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-[{"id": "FDA-1994-P-0003", "title": "ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/60mg-CLOSED", "context": "2023-05-02T10:36:48Z", "comments": []}, {"id": "FDA-2009-P-0429", "title": "Declare That the Product Tramadol Hyrochloride and Acetaminohen Tablets, 75 mg/650 mg is Suitable for Consideration in an Abbreviated New Drug Application (ANDA) - CLOSED", "context": "2022-01-05T01:03:55Z", "comments": []}, {"id": "FDA-2022-P-1863", "title": "Request that the FDA take the following two actions described below: 1) Update language in the labeling of sublingual buprenorphine products approved to treat opioid use disorder (OUD). 2) Issue a drug safety communication (DSC) to providers highlighting the potential clinical benefit of sublingual buprenorphine doses >16mg/day in patients with OUD.", "context": "2023-02-03T09:31:21Z", "comments": []}, {"id": "FDA-2018-P-0673", "title": "Requests that the FDA produce a study on control of alprazolam products in relation to the overall effect on the Opioid crisis in the USA.", "context": "2021-02-17T17:40:12Z", "comments": [{"text": "If someone is poisoned by lacing punch, gummie bears or whatever, it is not the drugs fault, it is the person delberately tampering with the food, beverage committing murder. Does the date rape drug take the rap when someone puts it in another persons drink? Is it guilty of the crime?
Despite what ignorant individuals are stating, the only people suffering from the opioid crisis are the people that need the medication to live. The lives of people with horrible medical conditions have been destroyed. The lives of the elderly have been destroyed. The correct od stats are 17k. People do not take the time to fact check the current 'fad." Govt quietly corrects data while continuing to disseminate erroneous data,
MILLIONS OF PEOPLE WITH ILLNESSES WHO PREVIOUSLY WERE ABLE TO FUNCTION, CONTRIBUTE TO SOCIETY ARE NOW INCAPACITARED AND IN EXRUCIATING PAIN. YOU HAVE DESTROYED THEIR LIVES AND THEIR FAMILIES AND WE BY FAR OUTNUMBER THE POOR LITTLE ADDICTS WHO COULD CARE LESS ABOUT ANYTHING OTHER THAN GETTING THEIR ILLEGAL FIX ON THE STREET.
THE SICK ARE NOW COMMITTING SUICIDE DUE TO NONSTOP PAIN.
STOP PICKING ON PEOPLE WITH ILLNESSES OF ANY KIND.
THERE SHOULD NOT BE A SIGN IN A CANCER DOCTORS OFFICE STATING THEY CANNOT GIVE YOU THE MEDICATION YOU NEED FOLLOWING CHEMO AND RADIATION.
THE DEA LIES ABOUT DRUG SHORTAGES FOR THE SICK, WHILE THE FDA WEBSITE LISTS THEM AS SHORT.
IGNORANT AMERICANS YET TO BE AFFECTED BY THE FACT THAT PAIN KILLS CONTINUE TO PREACH WITHOUT KNOWING THE CORRECT STATS OR THE TRUTH.
PERSECUTION OF PEOPLE IN PAIN OR ANY ILLNESS NEEDS TO STOP.
MAKING IT HARDER FOR SOMEONE THAT MEDICALLY NEEDS OPIOIDS OR XANAX IS IRRESPONSIBLE.
Figures Lie and Liars Figure Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard Lawhern, National Pain Report, 11/17/17
http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.html
CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, JEFFREY A. SINGER, 3/22/18
https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-high
Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.
Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.
https://www.ncbi.nlm.nih.gov/pubmed/28402482
B.C. doctors cant limit opioids or discriminate against pain patients
CAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18
https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/
The Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17
https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935
The truth about the US opioid crisis prescriptions arent the problem
Marc Lewis is a neuroscientist/author on addiction, The Guardian
https://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptions
Fentanyl & Heroin Deaths Lead Soaring Overdose Rate, 12/21/17, PNN
https://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-meds
Why Untreated Chronic Pain is a Medical Emergency
1/28/18 by Pharmaciststeve http://www.pharmaciststeve.com/?p=23988
Untreated Chronic Pain can Kill! 6/20/17 Suzanne Stewart, NPR
http://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.html
CDC Report Ignores Suicides of Pain Patients, June 07, 2018, Pat Anson, PNN
https://www.painnewsnetwork.org/stories/2018/6/7/cdc-report-ignores-suicides-by-pain-patients
Jeffrey M Geurin, Staff Sergeant, United States Air Force 1997-2008
https://www.regulations.gov/document?D=FDA-2018-N-1621-1264
Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17
https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227
Response to: FDA-2017-N-5608
by: Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MD
U Alabama at Birmingham School of Medicine & Yale School of Medicine
https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938&attachmentNumber=1&contentType=pdf
Time: Report: Chronic, Undertreated Pain Affects 116 Million Americans
By Maia Szalavitz 6/29/11
http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/
10 Myths About the Opioid Crisis, Pnn
https://www.painnewsnetwork.org/stories/2017/12/24/10-myths-about-the-opioid-crisis
The other opioid crisis: hospitals are running short of powerful painkillers
PAULINE BARTOLONE, KAISER HEALTH NEWS
http://www.latimes.com/business/la-fi-opioid-painkiller-hospitals-20180316-story.html#
In the midst of a massive opioid crisis, hospitals are experiencing an opioid shortage
Aaron Schachter, 5/14/18
https://www.marketplace.org/2018/05/14/health-care/midst-massive-opioid-crisis-hospitals-are-experiencing-opioid-shortage", "comment_id": "FDA-2018-P-0673-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0007", "comment_date": "2018-08-10T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5323}, {"text": "We highly object. Making it difficult for people who legitimately need medication is not the way to stop overdoses from illegal street drugs which are many times laced with heroin. The majority of deaths are due to ILLEGAL drugs bought on the street. By restricting opioids and in this case xanax, you are only driving up the black market for these illicit drugs. People who actually need these medications are being denied access and in some cases are probably now desperate enough to try impure illegal drugs in order to manage medical conditions. Who benefits? The drug cartels which now have even more people to sell to as restricting access has now driven up demand. Since the crackdown on opioids began, we now have even more ER overdose cases. Guess what, they aren't from legitimate prescriptions, but street laced "copies" especially fentanyl. And for the record, someone could just as easily kill them-self with alcohol (a central nervous system depressant) tobacco, tylenol, aspirin, antihistamines...To combat illegal drugs, you should be looking to the DEA to crack down on drug cartels, pill mills and hey how about looking into those drug and alcohol Rave parties. Children and teens need to be properly educated by their parents. It is time for people to start taking responsibility for themselves and to stop blaming drugs. This is like blaming steak knives for every stabbing death and banning them. What about butter knives? They can kill as well. And knives don't just get up off the table and stab someone, just like drugs don't just jump out of their bottle into people's mouths or up their noses. There will always be something illegal on the street that entices some people to get high. Targeting legitimate prescriptions only creates additional suffering and hardship for those that need the medication, while those abusing it still have access to their illegal supply.", "comment_id": "FDA-2018-P-0673-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0004", "comment_date": "2018-03-19T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 1926}, {"text": "In order to ensure that Alprazolam (Trade Name Xanax) be more strongly controlled in distribution and use I support moving it from Schedule 4 to Schedule 2.
In the United States the drug continues to show up in overdose cases implicating it as a contributor to overdose situations which lead to hospital visits, temporary or permanent debilitation and death.
I find this petition to be in good order becamse Alprazolam has an actual and growing potential for abuse not only of the drug by itself but in combination with other drugs such as both the natural and synthetic opioids.
Scientific evidence of its pharmacological effect continues to indicate it is a serious mood, mind and body altering drug which must be distributed in only rare cases.
The state of current scientific knowledge regarding the drug's interactions with other drugs, such and natural and synthetic opioids as well as the psychiatric states it can trigger have been recorded in studies that the manufacturers continue to marginalize.
Over the course of its (relatively) brief history a pattern of abuse has arisen for the drug itself and it is now being used in combination with other drugs to create specific life endangering effects.
The scope, duration, and significance of abuse is increasing at a high rate over time. The control of the current supply has clearly been lost.
The risk there is to the public health continues to be loss of mental ability, physical ability and life. The debilitating effects of the drug lead to the curtailing of economic activities by family members which damage growing children, other family members and the entire community in which these tragedies occur. Death is also expensive.
The psychic and physiological dependence liability is clear and warned about. It is hard to manage with an individual of general intelligence and strength let alone someone suffering from the very symptoms this drug is supposed to alleviate.
", "comment_id": "FDA-2018-P-0673-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0005", "comment_date": "2018-07-25T04:00:00Z", "comment_title": "Comment from Alfred Brock", "commenter_fname": null, "commenter_lname": null, "comment_length": 2027}, {"text": "I am a 55 year old female and disabled since MVA in 2005. I am a RN and worked as a nurse for 35 yrs. I have had multiple surgeries due to the accident and also was diagnosed with Hep C that was contracted in the late 80s from a blood transfusion. I was infected for more than 20 years before being aware and it quietly destroyed my liver. I was blessed to bedcover a perfect match at the very last moment and I have been cured of the Hepc now. However I continue with severe chronic pain and my new liver has complicated my options for pain relief. My doctors had found the best medication for me wS Fentanyl patch. It worked well for me for many years. My life and activities were greatly improved. My liver health had been great for 5 years. Since the opioid rules I have lost two of my PCP because they could not prescribe to me. My liver enzymes have been spiking since they took the patch away. My BP has been extremely high at times. I have allergies to a few pain medications and many I simply cant have for reason of causing harm to my liver. Now being sent your in paon management clinics that insist on painful injections that I was told by my doctors I could not have. I pay huge copays and family must run me to appointments that last for hours. They never put hands involved me nor read my piles of records. They send me for repeated Scans MRIs and such for proof that I already have in my records. I am now on oxycodone pills that they previously took me off due to allergy. I continue to have pinching in my liver and my daily pain is 9-10. I never sleep through the night due to constant pain. I need more oregano surgeries but due to my health now I worry about the risks. My life now is very difficult I am depressed and tearful most days. I have 5 sons and 4 grandchildren and fur to my pain I rarely can participate with them and depression again.Before all of this Opioid crisis my quality of life was good. Pain was minimal and I enjoyed my family had normal relations with my husband. I even thought I could possibly work a few hours a week sitting at a desk. I very much miss my job as a nurse. Even if u could not go back to work at least I felt a timed I could be purposeful. Its no longer the case.all I can do now is happily retire and spend days enjoying life and my grandchildren Burbank thats option is gone. I have to have pain control and the proper medication that does not harm me. Like it or not Fentanyl worked well and I had complications. I seem to put that small percentage that. Policy and lawmakers has not considered. I refuse to have my life taken away after all I have been through. I want my PCP back and not be told he will risk losing his license to care for medical ", "comment_id": "FDA-2018-P-0673-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0006", "comment_date": "2018-07-25T04:00:00Z", "comment_title": "Comment from Denise R Niemi", "commenter_fname": null, "commenter_lname": null, "comment_length": 2717}, {"text": "I am a 41 year old disabled women. This is ridiculous on how Congress want to restrict the people who really need pain meds even more. I had to get 3 spinal surgeries and still have pain, muscle spasms, permanent nerve damage and pain. It is hard doing everyday activities. In my spine I have 15 titanium rods, 4 cages and 2 spacers. My back is permanently damaged. I have depression and anxiety disorder. It is a hassle to see the doctor and they consumed with the fear of prescribing pain meds. What are the people with real pain going to do? You guys are going at this wrong. Us economically disproportionate patients will suffer. The people with money will have access. I am tired of the lack of care. The state of Florida medical is worse. I am always compliant, get drug tested and go to my appointments. Why do I have to suffer?", "comment_id": "FDA-2018-P-0673-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0008", "comment_date": "2018-08-10T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 836}, {"text": "I object to this matter.
I have been on alprazolam for 4 years. Obtaining this medication was not simple. I had multiple breathing attacks during the day, I've had my left side go numb, and multiple physical symptoms due to severe anxiety. The stigma already surrounding mental health is a hindrance to individuals who seek care. Why make this more complicated thus increasing the likelihood of self medicating a mental issue? This issue would been seen heavier on other sides such as alcohol as patients self treat anxiety in ways not helpful. Stop hindering the accessibility to mental health, and medications used appropriately are far less likely to be abused, because when someone needs it, they don't feel it. I don't "feel" Xanax. I begin to have a normal heart rate and other symptoms gone. Yes counseling helped give me tools to help, but xanax is also a necessary tool. We deserve a quality of life. We did not choose this. ", "comment_id": "FDA-2018-P-0673-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0010", "comment_date": "2018-08-14T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 966}]}, {"id": "FDA-2022-D-1847", "title": "Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency", "context": "2022-11-03T13:44:18Z", "comments": [{"text": "My son died September 11th, 2019 from an accidental overdose. He had overdosed twice before he died and it was only because of Narcan was he able to live another day. I have been talking to pharmacist, doctors, and the public in general and it is unbelievable how little they know about this lifesaving drug. I implore the FDA to please invest in a campaign of awareness concerning Narcan so that we can Save Just One. Someone dies every 5 minutes from an overdose or poisoning in this country. We are losing an entire generation.", "comment_id": "FDA-2022-D-1847-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0004", "comment_date": "2022-11-03T04:00:00Z", "comment_title": "Comment from LeAnne Burdette", "commenter_fname": null, "commenter_lname": null, "comment_length": 530}, {"text": "We are talking about lives here! The lives of the person who tried pot for the first time and it was laced with Fentanyl. The addict who couldn't no more and his overdose was a suicide attempt. We should have vending machines at every corner with Naloxone!. I understand regulations are necessary to keep individuals safe, but the individuals that need Naloxone are those not following regulations. I thank you for absolutely taking the initiative to lift regulations temporarily while we can get these numbers down. We should not limit a lifesaving medication by restricting it to prescription. Have not only harm reduction organizations carry it but recovery community organizations, rehabs, schools, libraries. Make it AVAILABLE! Easily accessible. ", "comment_id": "FDA-2022-D-1847-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0003", "comment_date": "2022-09-29T04:00:00Z", "comment_title": "Comment from Alex Grimes", "commenter_fname": null, "commenter_lname": null, "comment_length": 756}]}, {"id": "FDA-2007-P-0352", "title": "Determine That the Listed Drugs, Oxycodone Hydrochloride Extended Release Tablets, 15 mg, 30 mg, and 60 mg, Were Voluntarily Withdrawn by Purdue Pharma LP, for Reasons Other Than Safety or Effectiveness-CLOSED", "context": "2021-09-01T01:01:07Z", "comments": []}, {"id": "FDA-2002-P-0049", "title": "ANDA Suitability for Oxycodone and Acetaminophen Tablets-CLOSED", "context": "2021-09-01T01:03:00Z", "comments": []}, {"id": "FDA-2004-P-0098", "title": "ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 mg acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen", "context": "2021-09-01T01:02:10Z", "comments": []}, {"id": "FDA-2009-P-0459", "title": "To Permit the filing of an abbreviated new drug application for buprenorphine hydrochloride USP 8 mg combined with naloxone hydrochloride USP 2 mg in an orally soluble strip format to be marketed as Buprox", "context": "2022-01-05T01:03:53Z", "comments": []}, {"id": "HHS-OS-2009-0007", "title": "Proposed Rule on Buprenorpine Dispensing In Opioid Treatment Programs", "context": "2019-01-11T01:04:12Z", "comments": [{"text": "Comment 4", "comment_id": "HHS-OS-2009-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0006", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # fr_doc_num", "commenter_fname": "Ronald", "commenter_lname": "Pike", "comment_length": 9}, {"text": "see attatched file", "comment_id": "HHS-OS-2009-0007-0008", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0008", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Elizabeth", "commenter_lname": "Stanton MD", "comment_length": 18}, {"text": "please see attached comments from the Cleveland Clinic", "comment_id": "HHS-OS-2009-0007-0003", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0003", "comment_date": "2009-07-20T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "blair", "commenter_lname": "barnhart", "comment_length": 54}, {"text": "Comment from Robert Newman, M.D.", "comment_id": "HHS-OS-2009-0007-0010", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0010", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Robert", "commenter_lname": "Newman", "comment_length": 32}, {"text": "Please see the attached PDF file", "comment_id": "HHS-OS-2009-0007-0014", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0014", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Thomas", "commenter_lname": "Merrill", "comment_length": 32}, {"text": "See attached.", "comment_id": "HHS-OS-2009-0007-0012", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0012", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Elinore", "commenter_lname": "Mccance-Katz, M.D.", "comment_length": 13}, {"text": "August 17, 2009
Re: Dockett No. CSAT 001, Proposed Rule Change for Buprenorphine Take Homes for Opioid Treatment Programs (OTPs)
At Texas Clinic, we started utilizing buprenorphine, specifically Suboxone, soon after it was approved for usage in our OTP. We have had great success with this medication, as it seems to have reached a new population of individuals addicted to opiates.
Our main problem from the very beginning in giving buprenorphine to our patients has been the cumbersome take home restrictions identical to those placed on methadone dispensing. We are constantly having to get exception requests for take homes while our colleagues in private practice were simply able to prescribe or dispense Suboxone with no such restrictions.
The take home restrictions have definitely been a deterrent to successful treatment. Over the years, we have had patients drop out of treatment while waiting for their take homes to be processed for approval or simply switch to a private practice (which actually cost them more) because they had freedom to work, go to school, or manage their household more easily.
We would strongly be in favor of lifting any take home restrictions on buprenorphine in OTPs and, therefore, amending the Federal OTP regulations as soon as possible. In this vain, we would further propose that an emergency order be issued, lifting such restrictions immediately, to avoid the possibility of any other patients leaving treatment, relapsing, and going back to a life of abusing opioids.
Thank you for allowing us to comment on this proposed rule change.
Sincerely,
Farrukh Shamsi, MBA
Executive Director
Texas Clinic Fulton
6311 Fulton St.
Houston, TX 77022
(713) 694-8100", "comment_id": "HHS-OS-2009-0007-0009", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0009", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Farrouk", "commenter_lname": "Shamsi", "comment_length": 1798}, {"text": "Please find comments by the American Society of Addiction Medicine, regarding the approval of take-home buprenorphine within OTPs, attached. (Docket No. CSAT 001) Thank you.", "comment_id": "HHS-OS-2009-0007-0007", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0007", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Alexis", "commenter_lname": "Geier-Horan", "comment_length": 175}, {"text": "See Attached", "comment_id": "HHS-OS-2009-0007-0011", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0011", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Charles", "commenter_lname": "O'Keefe", "comment_length": 12}, {"text": "See Attached.", "comment_id": "HHS-OS-2009-0007-0013", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0013", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Doug", "commenter_lname": "Kramer", "comment_length": 13}]}, {"id": "FDA-1989-P-0003", "title": "MORPHINE SULFATE IN CAPSULE FORM ANDA SUITABILITY-CLOSED", "context": "2021-09-01T01:02:22Z", "comments": []}, {"id": "FDA-2009-P-0252", "title": "Opioid Risk Management", "context": "2022-01-05T01:03:40Z", "comments": []}, {"id": "FDA-2019-N-0299", "title": "Nonprescription Naloxone Labeling Resources", "context": "2019-03-11T08:39:00Z", "comments": []}, {"id": "FDA-2010-P-0593", "title": "Determine whether FENTORA\u00ae (fentanyl buccal tablet) 300 mcg (NDA 021947) has been voluntarily withdrawn , discontinued or withheld from sale for safety or efficacy reasons - CLOSED", "context": "2011-04-18T16:11:12Z", "comments": []}, {"id": "FDA-2011-N-0802", "title": "Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop; Request for Comments", "context": "2015-09-11T10:39:47Z", "comments": [{"text": "Please see the attached letter from the American Association of Nurse Anesthetists.", "comment_id": "FDA-2011-N-0802-0045", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0045", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from American Association of Nurse Anesthetists (AANA)", "commenter_fname": null, "commenter_lname": null, "comment_length": 83}, {"text": "Please see the attached PDF document for comments submitted by the Drug Policy Alliance in reference to Docket No. FDA-2014-N-0998. Thank you.", "comment_id": "FDA-2011-N-0802-0047", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0047", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from Drug Policy Alliance", "commenter_fname": null, "commenter_lname": null, "comment_length": 142}, {"text": "I stongly support the increase availability of Naloxone in the prevention of Opioid Overdose. Making naloxone availalble saves lives! I work as a nurse on a adult detox center at the University of Minnesota, Fairivew and we have noticed an alarming upward trend of 18 y o to 28 y o heroin addicts. Most started with abuse of narcotics then switched to heroin. Many are motivated to come to treatment because a friend overdosed and died. Recently I cared for a young male who came in because he himself nearly died of an overdose but a friend did rescue breathing and got him to an ER. Unfortunetly this friend overdosed the next day and died. We just had a high school student overdose on heroin and alcohol and died. As a mother and a nurse I request you make naloxone and needles available to the public. One idea would be to have public health and/ or pharmacy's distribute the medication/syringes after a person views an informational adminstartion/safety video on an i-pad.
As a community in the Twin Cities we organized a multi -agencyOpioid coaltion to fight this horrific trend of young opioid abusers. Availability of Naxolone is one layer of a solution to this problem. Additonal prevention and public education measures are urgently needed for this nation wide epidemic.
Thank you,
Mary Kay Borgstrom RN
Opioid Coalition Prevention Leader
www.opioidcoalition.org", "comment_id": "FDA-2011-N-0802-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0006", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Mary Kay Borgstrom - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1403}, {"text": "See attached file(s)", "comment_id": "FDA-2011-N-0802-0044", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0044", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from CVS Health", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Working in Massachusetts on the opioid overdose prevention initiative has been one of the most fulfilling times of my professional life. Teaching a parent or loved one of an opioid addict, who is consumed with the fear of losing their loved one to overdose, how to reverse an overdose with nasal naloxone is unparalleled. Most people are amazed at how easy it is to save someone's life with this medication. There is so much misinformation around naloxone that it is crucial to educate the public on its use and importance in our society. None of us can change the fact that presently we are literally fighting for peoples' lives when we talk about opioid abuse, but we can save people from dying from an overdose. An overdose often opens the door for people to reevaluate their situation and look at treatment as a viable option. I did a focus group a few weeks ago and this came from a participant: "I don’t use drugs, but I have been here a lot, I’m an alcoholic. I have had alcohol poisoning and I was lucky to survive. So when I took your class I thought it was important to get Narcan, because you never know. I left here and went to a sober house. My first day in the house, a young kid overdosed on heroin. I used that Narcan and saved his life. I called 911, they came, they took him to the hospital, no issues. I need to get more Narcan. It’s important that alcoholics know that it does apply to them, it applies to everyone if you can save someone’s life. "", "comment_id": "FDA-2011-N-0802-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0004", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Hillary Dubois - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1521}, {"text": "Please see the attached PDF for our comments submitted in collaboration with the American Pharmacists Association. Also, the National Alliance of State Pharmacy Associations would like to again express our appreciation for the opportunity to participate in and serve as a panelist at the FDA meeting: Exploring Naloxone Uptake and Use. Thank you.", "comment_id": "FDA-2011-N-0802-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0046", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from National Alliance of State Pharmacy Associations and American Pharmacists Association", "commenter_fname": null, "commenter_lname": null, "comment_length": 346}, {"text": "Many news and research articles have been decrying escalating trends in overdoses and deaths from opioid analgesics and heroin. Yet, rarely is mention made of the fact that there is an effective and safe antidote for such tragedies — naloxone. Isn’t it time to stop the complaining, and conducting pilot studies, and to start using naloxone on a broad scale to finally address and ameliorate the problems?
Evidence-based comments by Stewart B. Leavitt, MA, PhD, executive director of the Pain Treatment Topics and Opioids911-Safety education projects are in an attached MS Word document.", "comment_id": "FDA-2011-N-0802-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0003", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Pain Treatment Topics (Pain-Topics.org) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 608}, {"text": "Hello,
The United States is a leader in preventing overdose deaths with the use of naloxone.
People from all over the world utilize the resources that have been produced in the US about naloxone. The US has the experience, research, and expertise to respond to this preventable epidemic; leading the way for so many other places.
Having naloxone empowers all parties to engage in meaningful and educational dialogue about the risks associated with substances.
", "comment_id": "FDA-2011-N-0802-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0016", "comment_date": "2012-06-13T04:00:00Z", "comment_title": "Erin K Gibson - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 500}, {"text": "Naloxone use by VA Police in a first responder role outside the VA Hospital on VA grounds or City property requires
regulations to outline clear authority for use.
The Minneapolis VA has extended the naloxone rescue kits to providers to prescribe to patients, in addition, seek to
enable our VA police officers to be trained and have clear authority to administer a potential life saving medication for
opioid overdose.
I have been unable to establish authority for VA Police to administer naloxone (prescription medicine) under a
standing order because a standing order for naloxone is for an unknown patient.
I have asked our VA Legal counsel but no information is available.
The VA Police Chief here in Minneapolis wants naloxone rescue kits available in the medical kits used by the VA officers.
Clinical staff want this as well.
VA Police officers are first responders to off-site areas(not in the hospital) that include apartments on this campus
and must call 911 for city ambulance response if needed. Naloxone could be useful.
Past history does include a drug overdose at VA run apartments, sadly naloxone would not have helped in that case.
The Chief anticipates need. Pharmacy Service will commit to training the officers in opioid overdose avoidance, recognition
and response.
", "comment_id": "FDA-2011-N-0802-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0040", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from Gary Zielke", "commenter_fname": null, "commenter_lname": null, "comment_length": 1372}, {"text": "The FDA should act swiftly to make naloxone available over-the-counter. Increased access to naloxone will help save the lives of opioid users who often do not receive professional medical help because of the fear of police involvement. The majority of studies that compare different reasons for delaying or foregoing a call for assistance find that fear of police involvement is the most commonly cited reason. I attached an additional file which contains more details on the relevant empirical research. These findings make a compelling case for expanding the availability of naloxone. Even if fear of police prevents the seeking of professional medical assistance, the administration of naloxone by a witness can still save a life. And since it is unlikely that the fear of police will be completely eliminated in the near future, naloxone must be a critical part of comprehensive overdose prevention plans. As of April 11, 2012, only six states grant help-seekers and victims limited immunity from prosecution for possession of controlled opioids. Even in states that have enacted these 911 Good Samaritan protections, awareness of the law may remain low. For example, a year after Washington passed their 911 Good Samaritan law, only one of out of six of Seattle police had heard of it and only one out of three opioid users had heard of it. Furthermore, no state has extended Good Samaritan immunity to distribution offenses, despite the fact that most nonmedical opioid users obtain these drugs from friends or relatives who share or sell them. In this context, naloxone must be available to ensure that fear of punishment does not inadvertently condemn overdose victims to a death sentence.", "comment_id": "FDA-2011-N-0802-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0007", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Jeffrey Joseph Cece - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1706}]}, {"id": "FDA-2007-P-0065", "title": "Determine that Any Versions of Tramadol for Once-Daily Dosing will Not Be Approved Prior to Expiration of Three-Year Period of Exclusivity for Ultram ER - CLOSED", "context": "2021-09-01T01:00:58Z", "comments": []}, {"id": "FDA-2016-P-1875", "title": "Requests that the FDA guidelines for the Optimal Dose and Pharmacokinetics for any Naloxone Containing Product Intended for the Emergency Treatment of Suspected Opioid Overdose in All Settings (Including Non-Medical Settings) by Individuals (Including Non-Medically Trained Individuals)", "context": "2016-07-28T12:59:34Z", "comments": []}, {"id": "FDA-2005-P-0327", "title": "Oxycodone Hydrochloride Controlled Release Tablets for Oral Administration, in strengths of 30 mg and 60 mg are suitable for submission as an ANDA-CLOSED", "context": "2021-09-01T01:01:24Z", "comments": []}, {"id": "CMS-2019-0111", "title": "Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2020 (CMS-1715-P)", "context": "2020-10-16T21:14:52Z", "comments": [{"text": "Sept 12, 2019
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS1715P
P.O. Box 8016
Baltimore, MD 212448016
RE: Medicare Program; CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and
Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid
Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an
Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of
Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper
Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion
Regulations [CMS-1715-P]
Dear Administrator Verma:
I am writing in response to the request for comments on the Centers for Medicare and Medicaid Services
(CMS) Calendar Year (CY) 2020 Revisions to Payment Policies under the Physician Fee Schedule (PFS)
and Other Revisions to Medicare Part B proposed rule.
I am a physical therapist assistant and am concerned about this potential regulation change. Physical therapy and occupational therapy services are critically important for improving patient function in order to return home or maintain their highest level of independence and quality of life.
I appreciate the opportunity to provide feedback to CMS on the proposed rule. Specifically, I am writing
in response to CMS proposed application of the CQ/CO modifier when outpatient physical therapy and
occupational therapy services are furnished in whole or in part by a physical therapist assistant (PTA) or
occupational therapy assistant (OTA).
I understand that Section 53107 of the Bipartisan Budget Act of 2018 (BBA), enacted on February 9,
2018, included the assistant adjustment as a pay-for provision related to the repeal of the Medicare Part B
payment cap for therapy services. However, if finalized as proposed, this policy will negatively affect
Medicare beneficiary access and add administrative burden. Further, if the application of the modifiers is
finalized as proposed, the access to and safety of vital outpatient physical and occupational therapy
services for the most vulnerable physically impaired beneficiaries will be compromised.
I ask the Secretary to not finalize these policies as proposed. Instead, I am requesting that CMS, in
finalizing the therapy assistant adjustment provisions of Section 1834 of the BBA, implement the
following policy:
1. When a therapist and assistant are jointly furnishing services to a patient at the same time as a
team, and the therapist is fully engaged in the service during that time, the service during that
time period should be identified as a therapists services and be allocated to the therapist.
2. That CMS define in whole or in part to mean skilled therapy service furnished by a PTA or an
OTA that is furnished under the supervision of a therapist, but independent of any time the
therapist is furnishing the service.
3. That only those units of services provided in whole or in part by the assistant should be subject
to the 10% de minimis standard, the CQ/CO modifier, and subsequently the 15% payment
adjustment, not all units of the entire therapy service.
4. That no new burdensome documentation requirements be added. At a maximum, sub regulatory
guidance could revised to include a statement such as The provider should have a mechanism in
place to provide evidence whether a specific service was furnished independently by a therapist
or an assistant, or was furnished in part by an assistant in sufficient detail to permit the
determination of whether the de minimis threshold was met.
Thank you for the opportunity to comment on the CY 2020 Medicare Physician Fee Schedule and
proposed rule.
Sincerely,
Alvin Fall
PTA", "comment_id": "CMS-2019-0111-6442", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6442", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 4096}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary."
", "comment_id": "CMS-2019-0111-6412", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6412", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1988}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6590", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6590", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1972}, {"text": "Thank you for recognizing and addressing the disparity between student documentation requirements for teaching physicians and their students and those for advanced practice nurses (APRNs) and physician assistants (PAs) preceptors and their students. Currently, CMS allows teaching physicians to review and verify any student documentation of the components of E/M services in the medical record, rather than re-document the work. However, this burden reduction policy was not applied to APRN/PA preceptors and their students. Excluding APRN/PA preceptors and their students from this policy had the unintended effect of heightening the challenge of securing preceptors for APRN/PA students when teaching clinicians are in short supply. The revision contained in the Medicare Physician Fee Schedule proposed rule will authorize all APRNs /PAs and physicians to review and verify rather than re-document work for all E/M services by all members of the medical care team (including APRN/PA students). This will remove the disparity and lead to parity among providers and burden reduction for all clinicians. Therefore, we support the inclusion of APRN/PAs in the proposed rule.
For additional information, please contact the AANP Government Affairs Office at 703/740-2529 or governmentaffairs@aanp.org.", "comment_id": "CMS-2019-0111-6713", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6713", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1348}, {"text": "As a physical therapist and employer of 5 Physical Therapists assistants, I urge the payment policy be reviewed and deemed not beneficial for patient care. The use of physical therapists assistants in the healthcare world is vital for efficiency and quality. The proposed decrease in reimbursement will negatively impact employment and likely lead to additional shortages of rehab professionals through the country. I fully understand the need for cost containment however strongly disagree with this methodology. I urge your committee or group to reconsider the payment reduction.
Sincerely, Joe Walters PT
Owner, Physical Therapy One
Portage, MI 49024 ", "comment_id": "CMS-2019-0111-6706", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6706", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 671}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6705", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6705", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1972}, {"text": "CMS,
I strongly disagree with the CY 2020 Medicare Physician Fee Schedule Proposed Rule update to certain CPT codes for cardiac PET Imaging (CPT codes 78491, 78492, 78x31, 78x32). I disagree with this policy as it is based off of incorrect data and observation. It appears that inaccurate overhead data, a lack of thorough survey inputs and non-"real world" assumptions have caused Medicare and the RUC to recommend changes to the work inputs associated with Direct Expense and Practice Expense values, that combined with an inaccurate utilization rate resulted in a proposed reimbursement decline that is significant enough to make it impossible for facilities to continue to offer cardiac PET services after January 1, 2020.
The RUC and Medicare relied on market survey data to provide inputs for calculating the technical component (TC) reimbursement. These flawed surveys provided incorrect data or incomplete data regarding equipment direct expense, utilization rate, and practice expense inputs. In addition, the surveys failed to assess the true cost of starting, operating, and maintaining a cardiac PET lab, omitting input allowances for numerous high cost requirements. Therefore, based on this flawed survey data, both the RUC and Medicare recommended a reimbursement value well below what is necessary for the technical operation of a cardiac PET laboratory. I request that CMS NOT commence with the proposed reimbursement in 2020 and instead allow reimbursement to continue at current levels.
", "comment_id": "CMS-2019-0111-6759", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6759", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1543}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule. Thank you for taking the time to review these comments.
Sincerely,
Pamela Thurman
726 Marina Village Dr
Grand Rivers, KY 42045-9010
", "comment_id": "CMS-2019-0111-6644", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6644", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1838}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.
Sincerely,
Ursula Waller
128 Marshall Rd
Buckhead, GA 30625-2906
", "comment_id": "CMS-2019-0111-6631", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6631", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1770}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.
Sincerely,
Jaclyn Taylor
108 S Elmhurst Ave
Mount Prospect, IL 60056-3125
", "comment_id": "CMS-2019-0111-6629", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6629", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1779}]}, {"id": "DOD-2013-HA-0085", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\r\nTRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE For Life Beneficiaries through the TRICARE Mail Order Program", "context": "2020-10-22T01:33:13Z", "comments": [{"text": "i BELIEVE THE EFFECTIVE DATE OF THE RULE FOR OPTING OUT SHOULD BE EARLY IN 2013 AS MANY OF US BEGIN USING MAIL ORDER AT THAT TIME IN ACCORDANCE WITH THE LAW.....NOW YOU BACK IT OFF UNTIL February 14, 2014. IT WAS NOT THE BENEFICIARY FAULT THAT THE PHARMACY BENEFIT MANAGER WAS NOT READY TO IMPLEMENT THE LAW....ITS A FIVE YEAR PROGRAM AND SOME OF US PLAYED BY THE RULES AND NOW FIND WE ARE PENALIZED. AFTER WELL OVER A YEAR IN THE PROGRAM, THE MAJOR PROBLEM IS THE LACK OF ABILITY TO COMMUNICATE WITH EXPRESS SCRIPTS....IN WELL OVER A YEAR, WE HAVE NOT COMMUNICATED WITH A PHARMACIST OR EVEN A TECHNICIAN. WE HAVE NO IDEA THE QUALIFICATION OF THE SO CALLED ADVOCATES IN PHARMACOLOGY. THE RULES FOR OPTING OUT AND FOR A WAIVER SHOULD BE MUCH MORE SPECIFIC. EXPRESS SCRIPTS WORKS HARD ON KEEPING THE MEDICATIONS ON TIME....BUT GOD FORBID IF THE PHYSICIAN CHANGES THE mg OR THE DRUG....IMPOSSIBLE TO COMMUNICATE THE ISSUE WITH THEM IN TIME TO MEET THE DEMANDS OF THE MEDICATION. I ALSO QUESTION YOUR SAVINGS FROM THE PROGRAM...IN A RECENT DOD/IG REPORT THEY SAY THE PROGRAM IS A WASTE OF MONEY......WHEN AND WHERE WILL THE LIST OF SELECTED MEDICATION FOR MAIL ORDER BE POSTED? .THANK YOU FOR LETTING ME COMMENT. ", "comment_id": "DOD-2013-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0002", "comment_date": "2014-01-17T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 1211}, {"text": "See attached file(s)", "comment_id": "DOD-2013-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0004", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached comments of the National Association of Chain Drug Stores.", "comment_id": "DOD-2013-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0003", "comment_date": "2014-02-10T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 78}, {"text": "Please see attached comments from the Iowa Pharmacy Association.", "comment_id": "DOD-2013-HA-0085-0005", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0005", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 64}, {"text": "See attached file(s)", "comment_id": "DOD-2013-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0007", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached comments from the Pharmaceutical Care Management Association.", "comment_id": "DOD-2013-HA-0085-0006", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0006", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 81}]}, {"id": "DEA-2020-0002", "title": "Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl into Schedule I", "context": "2021-12-02T01:00:58Z", "comments": [{"text": "In light of growing number of opioid overdose deaths in America (more than 70,000 people died of opioid overdose in 2017 according to the CDC), I support the permanent addition of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl to list of Schedule 1 drugs. These drugs are structurally similar to the opioid fentanyl but are not FDA-approved drug products. As a result, users of these drugs are not protected by the FDA's quality standards. According to the CDC, abusing unregulated opioids of unknown quality and potency represents a significant risk of opioid overdose to users. Opioid overdose has been estimated to cost the United States more than 400 billion dollars annually (according the White House Council of Economic Advisors). Additionally, I argue that the social and emotional damage done to American communities caused by the opioid overdose epidemic cannot be presented solely financial terms. In an effort to minimize the presence of unregulated opioid substances of unknown quality and potency in illicit drug markets, I support the listing of these subtances as Schedule 1 drugs, as they meet the DEA's requirements for Schedule 1 subtances. ", "comment_id": "DEA-2020-0002-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0011", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Brian", "commenter_lname": "Rogers", "comment_length": 1287}, {"text": "Why don't you get a chemist to make a list of all the chemical pictures that cause drug addicts who are using fentanyl to feel satisfied so that we don't do this stupid add five chemicals and China imports four hundred variants. The solution is to list every fentanyl variant as schedule 1.", "comment_id": "DEA-2020-0002-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0009", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 298}, {"text": "The proposal to reschedule fentanyl to schedule one under the Controlled Substances Act though honorable in intent, may potentially do more harm than good. A large portion of our population relies on controlled substances, such has fentanyl, to relieve their chronic pain. While these drugs were never meant to be a long-term solution, that has become the reality we must deal with. Rendering fentanyl illegal would leave many patients in a lurch, unable to access the care they were previously receiving. These patients would no doubt either receive a prescription for a different opioid or worse, obtain illicit substances to fill the void they are now left with. While prescription drugs make up a great portion of the opioid epidemic and I agree that alternative therapies need to be established, it would be foolish to forget the schedule one substances that are already contributing to this nation-wide crisis. The majority of fentanyl related deaths are due to its mixture with other substances that are already classified as schedule one. Creating more illegal substances will not solve the issue, rather add fuel to the fire that is the illegal drugs trade. ", "comment_id": "DEA-2020-0002-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0006", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1167}, {"text": "Here's a article reported by CNN's Madeline Holcombe which explains everything we need to know about the fentanyl crisis that we are dealing with here in central Ohio: "This Ohio county (Franklin) may need a second morgue to handle the number of fentanyl overdoses." [1]
In her article, Holcome discusses the opioid scourge that is heavily affecting my home state. The article stated that [Franklin] county has seen 23 overdose deaths from January 31 to February 7, Dr. Anahi Ortiz, the county's coroner, said in a statement on her Facebook page. The next day, the county had five more. Dr. Ortiz also stated that [fentanyl] is the deadliest drug in the US, according to the Centers for Disease Control. It is up to 100 times more powerful than morphine, and just .025 milligrams can be deadly.While Franklin County usually has one or two overdose deaths in a day, Ortiz said on Facebook, one 26-hour period in September 2019 saw 10 people dying of overdoses.That year, overdose deaths in the county were up 15% from the year before, and 90% were opiate related.
Fentanyl is a drug that affects everyone and is not limited to race, income, social class, age, education level, etc. It is a killer and can be fatal on someone's first dose because of its potency and the chemicals it is mixed with for the purpose of "cutting" it for sale on the street and larger profits for the dealers.
I have never had a friend or relative killed or had their lives destroyed by it, but I believe that I am in the minority. Almost everyone has been impacted by these drugs. We have all watched the news reports, watched documentaries, seen the impacts of the drugs in TV shows or movies... everyone knows it is a problem which needs a solution ASAP! We need to make it a schedule 1 narcotic and take every legal step to eliminate fentanyl from our streets, or neighborhoods, our schools, and our homes. Fortunately we are in the process of closing/controlling entry on our southern border where most of this lethal drug is being smuggled in from central and southern America. There is no simple, single solution to combating this fentanyl plague, all possible solutions need to be taken, and reclassifying fentanyl to a schedule 1 drug is a necessary step to take.
[1] Madeline Holcombe, This Ohio county may need a second morgue to handle the number of fentanyl overdoses, CNN, (February 13, 2020), https://www.cnn.com/2020/02/13/us/ohio-fentanyl-overdose-second-morgue/index.html.
Thank you for considering my comments and concerns.
Respectfully,
James E. Yerian
", "comment_id": "DEA-2020-0002-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0008", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "James", "commenter_lname": "Yerian", "comment_length": 2663}, {"text": "This is a drug I think is abused by people by age and it is terrible to see it get worse year by year. I am glad that people will be punished at a higher degree of law if they are using these drugs to ruins the lives of others by providing a source for this drug. I hope that this reclassification will prevent further deaths and addiction.", "comment_id": "DEA-2020-0002-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0010", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Jose", "commenter_lname": "Vargas", "comment_length": 340}, {"text": "Yes, this is good because the drug dealers are the words and much worse than the users.", "comment_id": "DEA-2020-0002-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0007", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Lily", "commenter_lname": "Grant", "comment_length": 87}]}, {"id": "SAMHSA-2022-0001", "title": "Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) (Revised)", "context": "2022-06-14T14:14:08Z", "comments": [{"text": "This is completely absurd and unjust! It is time to move past these destructive policies. If a person's physician believes it is in one's best interest to use a medicine, then the federal government should not be able to hold this against the person due to a failed test. This is very un-American! Cannabis is a very safe, and effective medicine. We should embrace it as such.", "comment_id": "SAMHSA-2022-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0007", "comment_date": "2022-04-13T04:00:00Z", "comment_title": "Comment from Richard Rousseau", "commenter_fname": "Richard", "commenter_lname": "Rousseau", "comment_length": 384}, {"text": "Although I believe Oral Fluid testing is a good thing for quick non dot testing, I think it is offering many opportunities for Cheating for DOT testing. There will be more and more companies that will begin to do their own testing with their Employees which leaves the opportunity for friends and colleagues testing each other and promotes collaboration between Staff and Employee", "comment_id": "SAMHSA-2022-0001-0023", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0023", "comment_date": "2022-04-26T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Bill", "commenter_lname": "Kincaid", "comment_length": 381}, {"text": "I believe that medical cannabis users should be exempt from fedral drug screen failures.", "comment_id": "SAMHSA-2022-0001-0022", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0022", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 88}, {"text": "his is slightly insane but a logical outcome of the federal government’s continued refusal to change its outdated, disproven, and harmful categorization of cannabis as a Schedule I drug.", "comment_id": "SAMHSA-2022-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0019", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Alexi", "commenter_lname": "Martinez", "comment_length": 192}, {"text": "This rule is founded on completely archaic ideas about cannabis and how it affects an individual. There is no science backing up the non-legitimacy of medical use cases for cannabis where in many circumstances, actually improves the life of the person who uses it. Personally I have suffered from high anxiety/depression and PTSD and using cannabis before bed helps me immensely to calm down and get good rest. Without it I typically have night sweats/terrors that severely affects my performance the next day. Using cannabis before bed however allows me to function fully the next day and show up to work and other responsibilities with a clear and balanced mind. The harmless nature of this drug truthfully should allow it to be legal federally. Even for non medical patients, it is far safer to be taken recreationally than something like alcohol. Having cannabis be a schedule 1 drug is completely erroneous but while states have laws allowing it to be used medically, we should honor that and not move retroactively. Progress needs to be made here to establish facts about cannabis instead of digging in our heels based off assumptions made by politicians from decades ago. More and more research is coming out showing the benefits of cannabis and how truly harmless it can be. We need to be a country that creates rules based off these facts in order to maintain the sense of freedom that we cherish here. ", "comment_id": "SAMHSA-2022-0001-0021", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0021", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment from Eric Florence", "commenter_fname": "Eric", "commenter_lname": "Florence", "comment_length": 1412}, {"text": "SAMHSA 2022-0001 is a throwback to a relic of reefer-madness legislature. All of this is the politically neurotic outcome of the federal government’s continued refusal to change its outdated, targeted, and medically harmful categorization of cannabis as a Schedule I drug. Please look yourself in the mirror and explain this, “a physician’s authorization or medical recommendation for a Schedule I substance is not an acceptable medical explanation for a positive drug test.” I'll help, it's a back asswards loophole to apply to try to regulate an innoxious substance. It's also funny how the most addictive substances known to man are considered safe enough to assign to Schedule II; live with yourself knowing that you helped fuel a crisis that ruins lives and kills people because of a nonsensical mindset of ignorance, greed, and fear. You won't read it but here's to you, cheers; https://www.npr.org/2022/02/25/1082901958/opioid-settlement-johnson-26-billion, https://www.newsnationnow.com/health/where-do-us-opioid-trials-settlements-stand/.", "comment_id": "SAMHSA-2022-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0011", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1091}, {"text": "As a qualified SAP from 05 to present I am in support for Oral Fluid Testing but with the following caveats: 1) ONLY Urine Testing should be used for the RTD Return to Duty test. 2) There should be no change to the SAP being the sole author of any employee's mandatory Follow up Testing Plan. The SAP is the one in the entire RTD process who is spending up to hours of time providing a clinical assessment and applying diagnostic criteria with backend recommendations for education or treatment or both. Thus, upon any employee compliance the SAP should be the only Service Agent type deciding the amount of Follow-up Tests but also if they recommend ORAL or URINE for Follow-up tests. I would advise that all Follow up Tests are URINE TESTS only. The Oral Test appear from what I read to be the way to go for Pre-employment Test, Random's, Reasonable Suspicion, Post Accident etc but the RTD and Follow up Test should ALWAYS be Urine based. If there is a choice on either for Oral and Urine testing for RTD and Follow-up Testing this call should ONLY be for the contracted SAP to make and never the employer or 3rd party TPA. ", "comment_id": "SAMHSA-2022-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0027", "comment_date": "2022-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 1135}, {"text": "Comment on SAMHSA 2022-06884
I am an operations manager at a public transit authority and think adding the ability to conduct drug testing using oral fluids will be a benefit felt across the board. Our organization would certify staff to be able to self administer oral fluid testing as well as use a clinic. Drivers would still have to go to a clinic for BAC testing, so we would not self administer that test. It takes a lot of planning and resources to pull drivers off route for random testing, send them to the clinic, wait at the clinic, then coordinate getting them back on route. Being able to self administer random testing will simplify the process and make it more convenient to test at all times of service.
Our practice would be to use urine tests for pre-employment, return to duty, and follow up. In the cases of shy bladders or the inability to produce a large enough specimen, we would be open to transitioning from urine to oral fluids before exhausting the time limit. We prefer pre, return, and follow-up to be more structured through a clinic and to use urine, especially for return and follow-up.
In response to the question of whether or not to allow opposite gender techs to observe urine collection, our team was split. The male point of view was it makes no difference. The human resources and female recommendation was to have it observed by the same gender. Past experiences show female staff were already stressed about being observed. To have the collection observed by a male would further exacerbate the situation. Just because someone is going through the follow up process doesn't mean they should lose their dignity. We understand in smaller communities it may be harder to find same gender techs to observe urine collections, but we don't have the issue in our area.
In response to the question of whether or not refusing an opposite gender observer constitutes a refusal to test, we assumed that the regulation wouldn't require same gender observers. We would recommend calling that a refusal to test. If your test requires observing, you must have already tested positive. We cannot give someone the ability to cheat the system if they know there aren't many same gender techs.
In summary, let's get oral fluid testing up and running and relieve some of the burden placed on organizations to maintain compliance with drug testing. A separate soap box issue I would like to see movement on is THC levels testing to remove the current zero tolerance policy that can last for up to 60 days after last contact/consumption. Safety sensitive industries need a better answer than zero tolerance when cannabis products and marijuana use are rising as fast as they are now. Zero tolerance is hurting staff retention and recruiting. ", "comment_id": "SAMHSA-2022-0001-0030", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0030", "comment_date": "2022-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 2811}, {"text": "Comments of Airlines for America attached.", "comment_id": "SAMHSA-2022-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0040", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 42}, {"text": "Official comment from OraSure Technologies, Inc. is attached.", "comment_id": "SAMHSA-2022-0001-0038", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0038", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 61}]}, {"id": "FDA-2000-P-0565", "title": "ANDA Suitability for Combo Hydrocodone Bitartrate & Acetamine-CLOSED", "context": "2022-01-05T01:01:53Z", "comments": []}, {"id": "FDA-2019-P-5268", "title": "Requests that the FDA and DEA initiate the proceedings for rescheduling 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, its optical and geometric isomers, and salts of these isomers (including tramadol) from schedule IV to schedule II of the CSA", "context": "2020-05-29T13:57:02Z", "comments": []}, {"id": "SAMHSA-2023-0001", "title": "Medications for the Treatment of Opioid Use Disorder", "context": "2023-05-08T13:37:08Z", "comments": [{"text": "I think it would benefit greatly if Telemed appointments were permanently available for inductions/first visits.", "comment_id": "SAMHSA-2023-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0007", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Powell, Kennedy, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Kennedy", "commenter_lname": "Powell", "comment_length": 112}, {"text": "As a public health professional, I strongly urge SAMSHA to adopt the proposed changes to medications for opioid use disorder (MOUD) regulations to increase access to these lifesaving medications and enable people with substance use disorder (SUD) to successfully discontinue illicit drug use and reclaim their lives. I currently serve as deputy director of Virginia Harm Reduction Coalition, a 501(c)(3) nonprofit providing harm reduction services to people who use drugs (PWUD) in Southwest Virginia. I have witnessed firsthand the struggles our clients face in accessing MOUD, including not being able to afford to take time off work for appointments and facing stigma at work when they do, difficulties with getting childcare to facilitate appointments, and difficulties obtaining transportation to access appointments. I have witnessed clients struggle mightily to remain in treatment only to finally succumb to the weight of these barriers and relapse. The closest Medicaid-accepting methadone clinic to Roanoke, Virginia, is located 50 miles away in Martinsville. Methadone is much more effective for many of our clients than buprenorphine (especially since Virginia law makes obtaining buprenorphine without a naloxone component impossible for most patients). The availability of telehealth appointments for methadone patients and the ability of patients to receive up to 4 weeks’ worth of medication enables many more of our clients to enter and remain compliant with treatment. It is an absolute game changer. ", "comment_id": "SAMHSA-2023-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0014", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Zabielski, Barbie, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Barbie", "commenter_lname": "Zabielski", "comment_length": 1526}, {"text": "While I absolutely believe addiction and addiction issues are a significant problem, I wanted to make sure that my understanding (and my doctor’s understanding is correct as it was told to me, a pain patient). The proposal’s wording leaves no choice for someone taking opioids to NOT be dependent either physically or mentally. Meaning, it is appropriate to code all patient’s claims who use opioids as at least “opioid dependence” diagnosis. They have no choice to do this even if their doctors have zero dependency concerns documented in the medical chart. Even if the patient has no dependency issues with the opioid(s) being taken. And I am assuming there will be some sort of protections for the patients to ensure that there will be no denial of organ transplants, should they ever be needed in the future because of this coding. Because again, the patient and doctor had no choice.", "comment_id": "SAMHSA-2023-0001-0017", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0017", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 918}, {"text": "Anything to make buprenorphine more easily accessible. It is by far the safest opioid. It's use to treat pain and opioid overdose should be studied and encouraged. It is safe enough to be dispensed over the counter to competent adults.
H B Edwards, MD
Addiction Psychiatrist
BehaveNet, LLC", "comment_id": "SAMHSA-2023-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0019", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "HOWARD", "commenter_lname": "EDWARDS", "comment_length": 306}, {"text": "I am an OTP methadone patient. I've watched as federal and state laws have provided easier access to treatment. However, this means nothing if the OTP or Methadone clinic does not adopt these rules. I have 14 years 100% compliant in my treatment but my clinic will not allow me to have more than 6 take home doses. According to Samhsa and my state law I should be getting up to 27 doses. People at other clinics with less time clean can get more takehomes than me. But because you make these changes and do not require these opioid treatment programs to follow, nothing will change. It's a shame. You just let people suffer and die and do nothing about it. I am told by the people who run the clinic that they get paid more when we have to show up in person more. So it's become about these companies money and bottom lines and not peoples lives and treatment. You all should be quite ashamed of yourselves.", "comment_id": "SAMHSA-2023-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0020", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 919}, {"text": "January 24th, 2023
Substance Abuse and Mental Health Services Administration,
Department of Health and Human Services
Re: Notice of Proposed Rulemaking on Medications for the Treatment of Opioid Use Disorder
Dear Sir or Madam,
I am submitting a comment in response to SAMHSA’s proposed rulemaking “Medications for the Treatment of Opioid Use Disorder” published in the Federal Register on December 16th, 2022.
I am a 4th year medical student with a little more than 3 months left before graduation. I recently completed my addiction psychiatry rotation and I hope to practice as a Family Medicine Physician with a strong MOUD patient panel. I strongly support the rulemaking regarding the removal of stigmatizing language and inclusion of principles of harm reduction and patient centered perspectives. However, I would like to draw your attention to a few areas where you can better realize those ideals.
While the proposed change to methadone provision rules is an improvement to the pre-COVID days, it leaves many harmful practices in place. I would like to draw from the attached article by Frank et. al. published in the Harm Reduction Journal. Here, the authors affirm the importance of take-home doses, but note that the take-home dosing guidelines are the ‘ceiling’, not the ‘floor’, as “individual clinics can adopt stricter policies if they choose”. These policies can take many different forms, many of which are not addressed by the proposed rulemaking. I have also attached the “Methadone Manifesto”, published in the American Journal of Public Health. While the whole article is worth reading, Box A details some recommended additions/changes to the rule. Notably, the elimination of negative drug tests as a requirement for take home dosing, elimination of burdensome bottle return or lock box requirements, and prohibition of accelerated tapering schedules/financial detox (often insufficient for adequate withdrawal).
It is my belief that federal policy truly rooted in patient centered perspectives and harm reduction would include these provisions. I recommend reading both attached articles to push the proposed rule to be as patient-centered as possible. The MOUD policies should be as empowering and non-stigmatizing as the proposed language changes suggest. Thank you for the opportunity to submit a comment.
Sincerely,
Jay Mainthia
", "comment_id": "SAMHSA-2023-0001-0034", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0034", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Jay", "commenter_lname": "Mainthia", "comment_length": 2510}, {"text": "My name is Jeffrey A. Singer, MD and I am a senior fellow at the Cato Institute, in the Department of Health Policy Studies. Please see my attached comment on the Proposed Rule.", "comment_id": "SAMHSA-2023-0001-0015", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0015", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Singer, Jeffrey, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Jeffrey", "commenter_lname": "Singer", "comment_length": 177}, {"text": "I am totally NOT in favor of SAMHSA adopting the Proposed Rule as is, in its entirety because it will create a huge financial hardship on the agencies that receive funding based on being CARF accredited if given one year or a non-accreditation outcome for more than a few recommendations that could be resolved within 60-90-days. Without a lot of details regarding why SAMHSA is moving into this direction, it is very difficult to really assess the pros and cons. However, one thing that I know is that agencies work hard to comply with CARF standards as well as overall service delivery to consumers and to put these stricter expectations as well as time restraints on these agencies appears to be a setup for failure. No agency is perfect and to say an agency can only have a hand full of recommendation is not reality because of the overall diversity within all agencies. It is not a one size fit all type of situation. The reason why agencies have chosen to comply with CARF standards as initially written is because we were want to provide a high level of care to our consumer based on surveyors' overall feedback within a reasonable amount of time to correct issues, etc. This is not a agency at large friendly proposal. ", "comment_id": "SAMHSA-2023-0001-0042", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0042", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": null, "commenter_lname": null, "comment_length": 1238}, {"text": "I wanted to say that I think this is a good thing for MH & addicted patients, also think that MH patient for some if not most should not be taken away our rights to certain anxiety and panic attacks meds such as benzodiazepines. When I came to South Carolina from California I had to quit on my own wt benzodiazepines because no doctor here would refill it.I would like to suggest for more groups & resources for MH patients as is almost non existent here in SC. I don’t think MH or addiction should be stigmatized anymore.!!! Thank you ", "comment_id": "SAMHSA-2023-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0027", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Rose", "commenter_lname": "Muniz", "comment_length": 551}, {"text": "To expect a treatment center to not have a singular standard (out of 1900) out of conformance seems like an unrealistic expectation. If a surveyor finds one treatment plan out of all the charts that they look at and that treatment plan was completed a week after its due date. Then that would be the one singular out of conformance that they are allowed to have for their entire survey (now they know they are only going to get a one year and they are stuck in compliance nightmares all year for every clinic they have). This regulation would force surveyors to decide if they should make any recommendations to the clinic to help them improve or decide that it is crucial for the clinic to stay open to treat patients so they must ignore any issues and just issue a perfect 100% survey at every location to ensure access to treatment for patients. It defeats the purpose of professional consultation and makes the survey process punitive.", "comment_id": "SAMHSA-2023-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0040", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Scott", "commenter_lname": "N", "comment_length": 943}]}, {"id": "DOD-2011-HA-0085", "title": "TRICARE; Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries", "context": "2020-10-22T01:28:06Z", "comments": [{"text": "See attached", "comment_id": "DOD-2011-HA-0085-0035", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0035", "comment_date": "2012-03-01T05:00:00Z", "comment_title": "NAABT Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "Dear Sir/Ma'am,
Please note my strong support FOR the proposed rule change.
The exclusion of maintenance therapies for addiction treatment because they are "addictive" ignores best practices in the medical treatment of substance use disorders, ties the hands of service providers, and makes recovery from chemical dependence harder for patients to achieve.
The proposed rule change would increase the effectiveness of treatment for this life-threatening and widespread illness.
Thank you,
William Aprill
LCSW-BACS, LAC, CCGC", "comment_id": "DOD-2011-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0002", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 565}, {"text": "Patients enrolled in a methadone clinic accept a high level of supervision and demonstrate a commitment to their recovery.", "comment_id": "DOD-2011-HA-0085-0017", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0017", "comment_date": "2012-02-14T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 122}, {"text": "I have submitted the comment below on letterhead using the file upload function. Here is the text.
As a researcher and clinician in the addiction field, I am writing to express my strong support for the proposed inclusion in TRICARE of coverage for methadone and buprenorphine maintenance for drug dependent individuals. Extensive research – much of it conducted with former military personnel receiving care in the Veterans Health Administration – indicates that opiate substitution therapies sharply reduce illicit drug use and risk of fatal overdose. These therapies have also been proven highly cost-effective.
At a time when a growing number of U.S. military personnel are reporting problems with prescription and non-prescription opioids, the addition of this benefit to TRICARE is critically important. For the regulatory change to be maximally beneficial to the health of our military personnel and their families, it should be coupled with extensive outreach to TRICARE providers to make them aware of the new insurance benefit.
Thank you for proposing this major step forward for the TRICARE program.
", "comment_id": "DOD-2011-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0003", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 1284}, {"text": "The use of opioid maintenance therapy on a long term basis has not been proven to improve functionality or reduce mortality or relapse. Most tests of the efficacy of opioid treatment therapy have been conducted on a short term basis. Research has shown that on a short term basis, those given methadone or buprenorphine reduce their use of other opioids, but only for as long as they are on the drugs. Many continue to use other substances such as alcohol, and continue to be at risk of overdose. Methadone overdoses have increased 400% from 2004-2008. Harm reduction philosophy (upon which use of an addictive substance is sanctioned to treat dependence on another substance) is an enabling philosophy that continues addiction, rather than treat it. As long as the person remains dependent on an abusable substance, he or she can never realize his/her potential as a whole, infinite spiritual being. It is a disrespectful and demeaning approach to the plight of the addict and keeps him/her shackled to the progression of this dangerous mental disorder and foreshortens his/her life. The use of chronic opioid therapy for chronic noncancer pain has created this epidemic of opioid dependent persons and yet so little is being done to stop the production of opioid dependent persons and much is being propagated about the "evidence-based" need for the use of more opioids to treat the problem. This is insane!", "comment_id": "DOD-2011-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0004", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 1419}, {"text": "The proposed change reflects the best evidence-based practice in the treatment of opioid dependence. I fully support this change in the applicable regulation.
I speak from the experience of prescribing buprenorphine (Suboxone/Subutex) since 2004 in the treatment of opioid dependence in the context of a comprehensive treatment program by our agency of which I am the medical director. I also support Opioid Treatment Programs that prescribe methadone in the treatment of opioid dependence along with counseling.
I am Board-certified in Internal Medicine and Addiction Medicine and have been working in the field of addiction medicine since 1989.", "comment_id": "DOD-2011-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0007", "comment_date": "2012-01-10T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 666}, {"text": "Dear Sir or Madam,
On behalf of the Ohio Department of Alcohol and Drug Addiction Services (ODADAS) Clinical Roundtable Committee, I am pleased to submit the following comments on the proposed rule related to TRICARE benefits, “Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (Document ID DOD-2011-HA-0085-0001).”
The Clinical Roundtable -- comprised of six senior clinicians and supervisors with established expertise in the clinical treatment of addictive disorders, drawn from ODADAS-certified treatment agencies from across the state -- strongly supports extending the benefit so that maintenance regimens of Medicated-Assisted Treatment (MAT) will be covered by TriCare. Scientific literature supports provision of MAT on an ongoing basis as being far more efficacious than alternative approaches, including detoxification-only or short-term utilization of MAT. Furthermore, several Roundtable members are familiar with the use of opioid replacement therapies (MAT) on an ongoing basis in their own agencies and have found it to be effective and practical.
The Clinical Roundtable also recommends addressing barriers that limit access to other clinical services (counseling, case management) within the TRICARE system. MAT is considerably more likely to be effective when combined with counseling and case management services; however, community agencies with the highest level of expertise in providing such services have found that they cannot receive reimbursement through TRICARE. While the Clinical Roundtable fully supports and recommends immediate action on the MAT proposal, there is a strong consensus that further access to addiction-related services needs to be addressed as well.
Thank you for this opportunity to provide comment. Please do not hesitate to call or email if I can be of additional assistance.
Sincerely,
Orman Hall, Director
ODADAS
", "comment_id": "DOD-2011-HA-0085-0026", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0026", "comment_date": "2012-02-27T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2019}, {"text": "See attached file(s)", "comment_id": "DOD-2011-HA-0085-0020", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0020", "comment_date": "2012-02-23T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached.", "comment_id": "DOD-2011-HA-0085-0033", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0033", "comment_date": "2012-02-28T05:00:00Z", "comment_title": "CSAC Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 13}, {"text": "On behalf of NAADAC, the Association for Addiction Professionals, which represents the professional interests of more than 75,000 addiction counselors, educators and other addiction-focused health care professionals in the United States, Canada and abroad, we thank you for this opportunity to submit comments to the Department of Defense regarding the TRICARE: Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (RIN 0720–AB54).
NAADAC applauds the proposed change in TRICARE policy regarding the use of therapeutic drugs in maintenance treatments for substance dependence. There is a wealth of medical evidence available that supports the belief that medication-assisted treatments are safe and highly effective. The extension of benefits to include these treatments increases the quality of treatment options available to TRICARE beneficiaries.
The use of medication-assisted treatments is not for everyone. Thus, we would recommend that included in the rule is a requirement that all individuals undergo an assessment prior to starting any medication-assisted treatment to ensure that they are receiving the appropriate care. We also recommend that there be a requirement that anyone receiving medication-assisted treatments also take part in a comprehensive psychosocial treatment program to be administered concurrently. We believe these added components will serve to prevent further dependence by assisting counselors in obtaining an ongoing assessment of the treatment.
While NAADAC does not have an official written statement outlining support for medicated assisted treatment for individuals with addiction problems, since 2005 we have been active in the development of training experiences surrounding this topic for addiction treatment professionals. Through a training program entitled “NAADAC’s Life Long Learning Series” five different training experiences have been developed and trained to ", "comment_id": "DOD-2011-HA-0085-0015", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0015", "comment_date": "2012-02-14T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2048}]}, {"id": "FDA-2017-P-6307", "title": "Request that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes pharmaceuticals LP (ANDA# A074769) as reference standard (RS) for the subject drug product to conduct in vivo bioequivalence studies.", "context": "2019-03-14T16:22:32Z", "comments": [{"text": "Goals for Chronic Pain Patients to receive adequate pain relief;
* For correct misinformation online and in Media about chronic pain patients and opioid therapy be amended and corrected!
* * institute a Chronic Pain Patients "Bill Of Rights".
-We all have a right to relief from our debilitating pain and discomfort.
* United Nations policy states PAIN MANAGEMENT IS A FUNDAMENTAL HUMAN RIGHT, under treatment or not treating is a crime against humanity and considered torture! That is what is being done to chronic pain patients all over this country right now! I being one of them as I am experiencing abandonment of care from my doctor. who has refused to treat me. Thus, I am in a very precarious state right now! I looking for a doctor. However, all pain management specialist are booked for at least a four month window! My pain is chronic 24/7, 365 days a year. I can't wait that four months. I do not want to end up as a statistic on the suicide list!
Since the narrative of the "opioid epidemic" has taken hold, some/ many doctors are refusing pain relief, in fear of retribution, imprisonment or loss of livelihood!
Many hospitals are implementing after surgery a spinal block and Tylenol, many patients are dying attributing it to cardiac arrest which is not the case!
#2 Collateral damage Because of the innumerable, severe, and long lasting effects of constant pain, I believe that treatment for chronic pain is a human right.
It impairs every part of a persons entire life, career, family, mind, body, spirit and soul. From financial hardships due to being unable to work and the family issues as we cannot be the parents, grandparents partners that we would have and should be.
Many chronic pain patients are hypo metabolizers or hyper-metabolizer ... I suffer with malabsorption I had a surgically inserted port in my chest.
I had tpn pumped into to my body for 12 to 24 hours a day for 8 + years.
I could not absorb the proteins in my food this is the way I sustained my life. It makes sense since food did not absorb either did my medication that is why I had to have higher doses For it to work.
We are not a one-size-fits-all society.
This creates, a lot of collateral damage to the family because we are not able to function in a fashion that our family needs us to ! It also starts to deteriorate our children's mindset as they are continually worried as to our health, expectancy of life/ longevity of life !
I know this first-hand has changed who my four children could have been ! It put too much weight on them while trying to go through school and life in general !
Because of all the family issues in addition to other health issues like brain and organ damage from lack of sleep, medications, and the rewiring of your brain from constant stress. Air condition, heating our sensory capabilities are all screwed up we need to help chronic pain patients get better treatment, education of the public on the complexities of chronic pain, lobby the government to make changes that will benefit chronic pain patients, and to foster a better understanding of chronic pain patients struggles day in Day Out with daily life.
After reading so many frustrating stories of chronic pain patients dealings with the healthcare industry, I decided to create a foundation that would serve the needs of chronic pain patients everywhere. By first educating the public on what chronic pain really is, how it affects us and our families, and what is missing in our treatment. Then I would like to focus on changing how government views chronic pain patients and writes guidelines and legislation that affects them.
For those of us who suffer day in and day out 24/7, 365 days a year Relentless, cruel, aching, affliction, agony, burn, catch, convulsive, cramping, crick, discomfort, distressing, fever, gripping, hurting, illness, injury, irritation, laceration, malady, misery, pang, paroxysm, prickling, sickness, smarting, soreness, spasm, stinging, stitching, straining, tenderness, thro, tingling , tormentous, torturous, troubling, twinging, wounding always present, horrendous, debilitating pain sharp, exacerbating,
There is a need in the chronic pain community and it is not being addressed, please we need to reduce the suffering as much as possible, of people suffering from chronic pain.
Suicidedue2pain
Malabsorbtion -TPN
Music therapy
Massage
Behavior therapy
Physical therapy
Biofeedback
Acupuncture etc
Three options - reform of opioid guidelines
3. Campaign/Organizational Goal and Key Objectives
Educating the public about chronic pain and how it affects chronic pain patients.
-Fight preconceived notions on pain medication and those who need it.
-What is missing from treatment of chronic pain?
-Changing governmental views
-Get new guidelines on pain medication created for chronic pain sufferers.
-Explain how the war on opioids is killing chronic pain sufferers!", "comment_id": "FDA-2017-P-6307-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0006", "comment_date": "2018-05-01T04:00:00Z", "comment_title": "Comment from CATHY KEAN", "commenter_fname": null, "commenter_lname": null, "comment_length": 5172}, {"text": "Dear Readers,
I am not certain how to write this letter, but I feel I must respond and comment on these regulations and have a voice in federal making of decisions.
I have been in chronic pain since 1984. In all these years since a respiratory infection ended with widespread body pain, I have not had one day without pain. The original disease has increased from musculoskeletal to inflammatory and degenerative arthritis throughout all my joints. Every X-ray is filled with arthritis and bone spurs, even bone in locations bone should not be. An MRI of my spine sent me to a neurosurgeon who said the only surgery that might work would never permit me to bend over again.
I take both diazepam and hydrocodone, in addition to medications you might not consider opioids or narcotics. These two are not high dosage, but they have worked and allowed me an active life. Daily I take care of horses, my own home, animals, and I work. I work as a writer and have had 16 books published while taking these medications. My main publisher has been WW Norton in NY. And for poetry, I have used a smaller, independent press. I also travel frequently to read my work, do workshops, and lecture on a variety of topics.
This is with my medications.
Without them, I am unable to get out of bed. I have had screams that are involuntary. I cannot bend or do any movement or work. My hands do not work, will not type, nor can I walk without severe pain. Without these medications, I will have no life, or
at least not one worth living.
The Dr. has changed. Even he has fear. He does not wish to prescribe medications like the ones I take, swears they would kill anyone else, all the exact same stories as the numerous other pain patients say they have heard. I feel sorry for those of us in pain, but I also feel sorry for those in the medical profession who are unable to really help their patients.
Many pain patients have been committing suicide rather than living a life suffering. These deaths are worse than the ones of addicts who are shooting up because they are created by the government's regulations and fear tactics. They are going after the wrong people.
Most of us are taking our meds at the right times, not asking for larger doses, and are responsible with our meds. We do not misuse our medicines. For us they are not addictive drugs, but healing agents that allow us to live full lives.
Please consider this in your Regulations. We do want to live. We do not overdose. We are not the criminals. We want to be free from pain, as anyone else also would.
Sincerely,
Linda Hogan
Professor Emerita
U of Colorado, Boulder
www.lindahoganwriter.com
", "comment_id": "FDA-2017-P-6307-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0003", "comment_date": "2018-03-28T04:00:00Z", "comment_title": "Comment from Linda Hogan", "commenter_fname": null, "commenter_lname": null, "comment_length": 2763}, {"text": "I'd like to start out by saying I'm a 39 yr old mother of 6. And have had chronic pain for over half my life.
I was 11 yrs old when I first started having back pain and then went on to knee pain. I was cative throughout school I was involved in track n field, volleyball, cheerleading & basketball. I had to wear 2 knee braces and was on a very high does of anti-inflammatory prescription from my knee doctor at age 12. After giving birth to my 3rd child at age 20 I had my 1st knee surgery, every year after that 1st surgery i had knee surgery after another for 5 years... I had been sent to neurologist's and physical therapy chiropractor and differant doctor's ect.
Finally at age 28 i found my dr and he referred me to a spine specialist and he diagnosed me with Schumann's disease which is very painful my spine was 69% curved on top and 69% curved on the bottom. They did surgery October15th 2010 and it was a very long recovery.
I've been on Percocet for 7 yrs and don't abuse it. I can't even get out of bed, walk or do basic self care without it. I've seen what drug addiction has done to our community and people i love.
But dont punish us that need our medication to live our basic daily lives.", "comment_id": "FDA-2017-P-6307-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0005", "comment_date": "2018-04-17T04:00:00Z", "comment_title": "Comment from Miranda MuellerMcClure", "commenter_fname": null, "commenter_lname": null, "comment_length": 1261}]}, {"id": "FDA-2016-P-1650", "title": "Requests that FDA assign a therapeutic equivalence (TE) rating of AA for Morphine Sulfate Oral Solution, 100 mg/5 mL (ADA 201517) approved on June 23, 2011-Withdrawn 3/12/2021", "context": "2021-03-25T13:23:26Z", "comments": []}, {"id": "FDA-2023-P-2656", "title": "Requests that the FDA determine whether ULTRAM (tramadol hydrochloride) Tablets, 50 mg, approved under New Drug Application number 020281, held by Janssen Pharmaceuticals, Inc., has been voluntarily withdrawn for reasons of safety or effectiveness", "context": "2023-10-05T12:36:32Z", "comments": []}, {"id": "FDA-1987-P-0012", "title": "ACETAMINOPHEN & HYDROCODONE BITARTRATE (TABLET & LIQUID)-CLOSED", "context": "2020-11-23T09:48:22Z", "comments": []}, {"id": "FDA-2021-P-0514", "title": "Requests that the FDA declare that Naloxone HC1 Nasal Spray, 8 mg/Spray, is suitable for submission as an ANDA and to introduce a new 8 mg/Spray metered spray strength for prescription use", "context": "2022-04-25T11:42:15Z", "comments": [{"text": "N/A", "comment_id": "FDA-2021-P-0514-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0007", "comment_date": "2022-04-25T04:00:00Z", "comment_title": "Comment from Foley & Lardner, LLP", "commenter_fname": null, "commenter_lname": null, "comment_length": 3}, {"text": "On behalf of Hikma Pharmaceuticals USA, Inc. (“Hikma”), the undersigned submits the following comments pursuant to 21 C.F.R. § 10.30(d) opposing the above-referenced suitability petition.", "comment_id": "FDA-2021-P-0514-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0006", "comment_date": "2021-08-20T04:00:00Z", "comment_title": "Comment from Lassman Law+Policy", "commenter_fname": null, "commenter_lname": null, "comment_length": 204}]}, {"id": "FDA-2005-P-0191", "title": "For patient safety and public health considerations, recommending scheduling tramadol under the Controlled Substances Act", "context": "2021-09-01T01:01:17Z", "comments": [{"text": "See attachment", "comment_id": "FDA-2005-P-0191-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0191-0005", "comment_date": "2016-03-22T04:00:00Z", "comment_title": "Comment from Ortho-McNeil, Inc. (Hyman, Phelps & McNamara)", "commenter_fname": null, "commenter_lname": null, "comment_length": 14}]}, {"id": "FDA-2016-D-0785", "title": "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products", "context": "2017-11-22T10:26:14Z", "comments": [{"text": "
My name is Jennifer Ford, and I have fibromyalgia. Including chronic pain, chronic fatigue, depression, anxiety, degenerative disc disease, COPD, just to name a few. I am able to barely maintain some level of a normal life with pain levels of a 5-6 on a good day. This is with the use of three hydrocodone a day. No more, no less. I receive a prescription of 90 per month. That's 3 a day, for 30 days. Take that away from me, and I have no idea what I'll do. Please leave chronic pain patients alone. We are patients, not addicts.
13", "comment_id": "FDA-2016-D-0785-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0008", "comment_date": "2016-05-09T04:00:00Z", "comment_title": "Comment from Jennifer Ford", "commenter_fname": null, "commenter_lname": null, "comment_length": 556}, {"text": "No more opioid guidelines that hurt the Chronic Pain community. My doctors are refusing medications they themselves put me on. We matter, the quality of our lives matter and our voices need to be listened to. Addiction within our community is very rare. ", "comment_id": "FDA-2016-D-0785-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0016", "comment_date": "2016-05-26T04:00:00Z", "comment_title": "Comment from C, Hope For The Hopeless Chronic Pain Issue's and Awareness", "commenter_fname": null, "commenter_lname": null, "comment_length": 254}, {"text": "I have taken opioids on and off for 30 years responsibly and safely. I have adhesive arachnoiditis. Without these meds many chronic pain patients will have no quality of life. What the government is doing is outrageous. You can buy codeine over the counter in Canada. It is not a gateway drug to heroin. Although the money grubbing addiction industry would like you to think so. The problem is heroin coming into the country from Mexico and China. If you want to fix the drug problem fix that. A new study shows that opioid overdoses peaked in 2012. Even if you take opioids off the market you will still have addicts acquiring it on the streets. You are throwing the baby out with the bath water. Patients who suffer everyday with excruciating pain rely on these medications to bring the pain down to a tolerable level. We take our medications responsibly. Any physician who says to take oxycodone off the market has no compassion. There is a place for opioids in medicine when the are prescribed responsibly. Pain patients are just getting warmed up! If you think we're going to tolerate this treatment you are wrong! ", "comment_id": "FDA-2016-D-0785-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0025", "comment_date": "2016-06-06T04:00:00Z", "comment_title": "Comment from Katherine Owen", "commenter_fname": null, "commenter_lname": null, "comment_length": 1124}, {"text": "I my name is James I have a chronic pain disease called rsd or crps. I use some of these drugs to control my pain and help me get through my day. There are many of us in the same position as I am. If you put uncentsable regulations on this we are going to be the ones that suffer from this for others stupidity pleases stop and think about the people that need this to get though our days and nights and to be able to spend time with our families. There are other ways to weed out the people that are abouseing theses drugs. I know we as the people of this country don't really matter to you people on any of these maters, but maybe just maybe for once in your time in office you will do the right thing and help the people that put you there. If you all had to spend one day in any of our shose you would understand where we are coming from. PLEASE PLEASE STOP AND THINK BEFORE YOU TAKE ANY ACTION ON THIS. If you were one of use you would be doing all you can't to take a different position on any of this.", "comment_id": "FDA-2016-D-0785-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0043", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from James Boles", "commenter_fname": null, "commenter_lname": null, "comment_length": 1016}, {"text": "Dr. Glapinski, I am a chronic pain sufferer and one who is DEPENDENT on oxycodone for a QUALITY OF LIFE. In reading your comment, you are aware that chronic pain pts depend on opiods and are in agreement, and then you turn around and say ban oxycodone. Just because you are against it for what ever reason, there are MANY LEGITIMATE chronic pain pts who retain a QUALITY OF LIFE by taking oxycodone. I have tried nearly all of them over the course of ten years. Opiods were my last resort, first came years of physical therapy, massage, chiro, accupuncture, epidurals, discographies, OTC AND NSAIDS that tore my stomach and liver up, facet injections, trigger point injections, nerve blocks, steriods, nerves burned, TENS, and two FAILED spinal fusions that left me with severe nerve damage. Oxycodone happens to be the one medication that agrees with me and takes my unbearable pain to a tolerable level, when I was on the right dose. Because of all these INHUMANE restrictions by the CDC, FDA, DEA and the government, Legitimate pain ots are having their once stable dose lowered to INEFFECTIVE DOSES or totally stripped of them, leaving many in agony and severe withdrawal. Shame on any of you doctors who abandon their patients. We are suffering from incurable conditions that cause severe pain, I beg God to take me daily. Would you do that to your Mom? Could you sit back and watch your loved one be at war with their body, stabbing, burning, crushing, piercing, pains, the emotional and mental toll it takes on a person, If your loved one got relief by taking opiods, would you want them to have some QUALITY OF LIFE and enjoy what they can or strip them of the only treatment they gave them some relief, force them to remain bedridden, shut off from society, many are turning to suicide to escape the pain. You doctors took an oath to do no harm. I get the DEA is targeting all our drs, there is way more harm being done to the chronically ill, we are being FORCED to suffer, to exist in hell, All the doctors thruout this country who believe in helping the suffering, especially when we've tried the alternative therapies OUR BODIES could take, it's physically, mentally and emotionally exhausting fighting this battle, then the stigma that is thrown on our backs, shame on all of you dra for not standing alongside the suffering. Perhaps if you treated each person as if you would your mom, maybe there would be compassion and empathy brought back into the dr/patient relationship. I see and hear nothing but NEGLECT, ABUSE, DEGRADING, DISCRIMINATION AGAINST LEGITIMATE PAIN PTS. Another fact is there is no opiod epidemic. The CDC used false data, even admitted to MISCLASSIFYING MANY heroin and fentanyl deaths, doubling and tripling one persons death, legit pain pts who committed suicide were listed an overdose, if alcohol or any other illicit drugs played a part the CDC looked the other way, they created mass hysteria that the media and government took off with, constantly demonizing a chronic pain pts LIFE SAVING MEDICATIONS. The CDC created FALSIFIED STATISTICS MADE TO FIT THE GOVERNMENTS ADDICTION DRIVEN AGENDA. Chronic pain pts are LAW ABIDING citizens who have DEBILITATING INCURABLE CONDITIONS, who have tried whatever was put in front of us by the medical community to get relief. We dont BREAK THE LAW, WE DONT ABUSE, SELL, SHARE, SNORT, OR ANYTHING ELSE TO OUR LIFE SAVING MEDS. WE ARE SICK FOR GOD SAKE. We are treated HORRIBLY by the medical community, treated like everyone is a pill seeking junkie, addict, and criminals. I am so fed up with paying the high price with my health and overall well being because of those who CHOOSE TO ABUSE, people who CHOOSE TO BREAK THE LAW, WHO CHOOSE TO POP DRUGS, OR GET DRUNK OFF ALCOHOL, PEOPLE WHO CHOOSE TO DESTROY THEIR BODIES, Addicts are given all kinds of opportunities to get help, all kinds of doors open for them, hell even the government passes out clean needles to shoot their drug of choice up with and safe houses to go get high and shoot up. When an addict, someone who CHOOSES TO ABUSE , fails a drug test during treatment they are given chance after chance, they aren't kicked out and turned away, A LEGITIMATE chronic intractable pain pts are turned away, judged and labeled as addicts, pts who have been with their drs for years and were on the same stable dose that worked for them are having meds reduced or taken away thru no fault of our own, for following the rules, getting drug tested monthly, shamed at the pharmacy, if you even find a pharmacy to fill your LEGAL lifesaving medication. Nearly all chronic pain pts have suffered for years and have years of medical records documenting their DEBILITATING INCURABLE conditions, usually has had many MRI's scans, tests, etc.These debilitating conditions only continue to worsen over time, so why are we decreasing legit pain pts meds when the doses really should be increased. How would it make you feel if your own mother were so poorly neglected!?", "comment_id": "FDA-2016-D-0785-0056", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0056", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Pam Molnar", "commenter_fname": null, "commenter_lname": null, "comment_length": 5013}, {"text": "1.Although the theme of the guidance seems, as expected, to proof that tested generic formulation (T) is not inferior to an approved AD reference formulation (R) and some studies were designed to test T against R directly, e.g. syringeability, introducing the control formulation (C) in some studies, e.g. extractability, created some confusion between qualifying an original brand name AD formulation (R) and a generic. We believe that, for generics, T should be tested directly against R, with no need for a third formulation (control), unless one route of abuse was not considered/listed on the R label.
2.There is no clarity if in-vitro testing need to be done or at least verified by a third party laboratory to avoid manufacturer's bias which we have noticed as a third party lab.
3.The draft guidance, as well as the previously approved AD guidance, focus on opioids but we believe that it should cover, also, non-opioids of potential abuse, e.g. amphetamines or molecules that can be precursor for recreational drugs, e.g. pseudoephedrine.
4.Smoking simulation study listed 233C as a definite temperature for heating but from our experience, this temp was not good to volatilize morphine or oxycodone and for which we needed to optimize the heating conditions. Not sure why the paper ignition temperature was used to set up this figure noting that different heating techniques including direct heating a drug on a piece of aluminum foil or putting a drug directly on ignited charcoal, e.g. "hookah", have been used. We believe that, smoking simulation studies should be optimized first using pure compounds and select the most effective heating condition/temp to test an AD formulation.
5.The guidance did not mention core separation as a part of physical manipulation for formulations with API is enclosed in a core within a hard shell.
6.The guidance did not mention saline solution for extractability or syringeability where it's a potential solvent that can be easily obtained by a drug abuser and safely injected. In this regard, for generics, we believe that all or representative solvents which were used to qualify an R should be used for T.
7.For particle size distribution following physical manipulation, 500 micron was used as a cut-off; does this mean no particle size characterization is needed below 500 micron?
8.Free base isolation; 233C for 2-15 minutes was listed to dry up a precipitated base without a rationale. From our experience, different temperatures and/or different heating times can be needed and noting that 233C was already suggested for smoking simulation, heating some compounds at this temp for 15 minutes may cause significant loss.
9.Liquid-liquid extraction was not listed but from our experience, after proper optimization, it was an efficient tool to isolate some opioids.
10.The guidance did not handle AD formulation which depend on conjugation of an active moiety to a pharmacologically inert side chain which needs to be cleaved inside the human body for slow release of the active molecule.
11.The guidance suggest 28 to 18 for syringeability and we suggest to consider either 28 or 27 as the latter is common and such small bore size should not make a difference compared to 28.
", "comment_id": "FDA-2016-D-0785-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0003", "comment_date": "2016-04-29T04:00:00Z", "comment_title": "Comment from Abdel Halim", "commenter_fname": null, "commenter_lname": null, "comment_length": 3791}, {"text": "I don't understand why you think that going after physicians & their patients, specifically chronic pain patients is going to somehow make this heroin epidemic lessen or disappear. I am a woman who was born with severe JRA at 15 months old, have had several surgeries, & other diagnoses along the way........Fibromyalgia, CFS, seemingly untreatable bi-lateral hip bursitis, constant back spasms, & the list goes on. I have for over 10 years been under the care of my wonderful rheumatologist & have ALWAYS listened to her, followed all directions, & more importantly NEVER, EVER given her reason to think I was doing anything otherwise. I am a perfect patient. My pain meds make my life liveable & when I say that....I mean my kind of liveable. I am permanently disabled so nothing is perfect, BUT being able to make dinner for my family at night & do some light housekeeping is only because of my pain meds. And now you want to make it harder? For what? Why? To eliminate what you think is the reason for heroin? Look around, do some more research. We have above pharmacy grade opiates coming across our borders & drug dealers are selling it to addicts. That's NOT us. Under 5% of the chronic pain community become addicts. Do we depend on our meds? Yes, but for living, for function, & so we are not bedridden. We aren't getting "high", we are getting some relief. There's a HUGE difference between physical dependence & psychological dependence. We are not in the latter group. Diabetics rely on their insulin, we rely on pain management. There is really no difference. Every medication comes with risks. You overdose on an over the counter medication too. It's called personal responsibility & because some don't practice that, you make ALL pay? You have already made getting our meds tougher with changing the scheduling class, breathing down the necks of our doctors, making them so scared to actually treat their patients now, pain contracts, random urine tests, pill counts, etc, etc...... What else do you want?? After all those things were implemented NOTHING changed with the addicts. In fact in one city next to me the drug use & overdoses have actually doubled since then! Seems like you are barking up the wrong tree. I get my meds, keep them in a fire safe locked box & practice good medication safety, but now I feel that at any moment my rheumatologist could pull the rug out from under me because of fear, or because you come up with some other crazy rule/regulation. She has already stated that it is out of her hands & she actually told me she will not longer prescribe pain meds to new patients, only the ones that are already on them. Really? Find another way to control this epidemic, because last I checked drug addicts don't hang out at rheumatologist, neurologist, or oncologists offices. Go after the drug dealers & the border. Please leave those of us that do nothing wrong alone. Will you release the suicide rates in the chronic pain community when they go off the charts? Because I have already read of SO many, & in many cases it happened because a physician got scared & just stopped their meds cold turkey, which is incredibly dangerous & in my opinion medically unethical. Those people end up in the ER & are treated like subhuman beings. Wow, that's really good medical care. Let the rheumatologists, neurologists, oncologists, & pain clinic physicians do their job. None of us want to be on these meds, but we have come to them because we have tried everything else. I have done physical therapy several times & got cortisone shots every 3 months for over 4 years. Give me a break! Until the scientists & researchers come out with some other medication and/or treatment that works as good as opiates, leave us alone. There are also so many of us that cannot take the conventional medications for our diseases because we have really horrible side effects, & opiates end up being our safest most effective treatment. Why punish the innocent people just trying to live a semi-normal life? When are you going to stop punishing the wrong group of people? Why should we pay for others bad decisions? I am disgusted & I don't deserve to be treated like this. The way pharmacists look at us, treat us, & even lie about how they "cannot" fill our prescriptions is beyond ridiculous. Thankfully I have a wonderful pharmacy. I ran a chronic pain support group on line for over 4 years & I heard the horror stories. They have been so bad I was forced to stop running the group.....between the stress & my own illness, well.....I just felt I had nothing left to give my members. Everything looks dim for them, & that's a sad state of affairs for people that have no choice, who were born with horribly painful diseases & illnesses. They aren't addicts, they are patients. Shame on the medical community, the government, the DEA, & the CDC. You aren't doing your job, you are just creating another problem. Looks good on paper maybe? Horrible!", "comment_id": "FDA-2016-D-0785-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0023", "comment_date": "2016-06-06T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5186}, {"text": "We are real chronic pain patients with real pain...........not drug addicts!", "comment_id": "FDA-2016-D-0785-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0071", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 76}, {"text": "The regulations against opiate pain medicine has been devastating to my family, to people I care about and to myself personally. I am not a pain patient or user of opiates but my husband who has been disabled for 20 years is a chronic pain patient. These regulations put him through on-going trauma, and pain. Our basic human rights are violated. We are not allowed to live where we want to, or in the state we want to, because we are prisoners to proximity to a doctor who will prescribe the essential medicine. To get this medicine he must submit to urine tests which violate his 5th amendment rights. Law enforcement doesn't belong in doctor's offices and hospitals! Basic human rights are disregarded in this failed "War on Drugs" created by Nixon for racist and evil objectives. Stop restricting medicines! Stop your "war" against the American people! Leave pain patients alone. Stop blaming suicides on pain medicine and look at the patients in chronic pain who are told that their only source of relief has been outlawed! Stop criminalizing self-medication. You are not supposed to control other people's choices with their own bodies. Citizens of the United States are back to having to reclaim their rights to self ownership.", "comment_id": "FDA-2016-D-0785-0078", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0078", "comment_date": "2016-07-07T04:00:00Z", "comment_title": "Comment from Heather Martin", "commenter_fname": null, "commenter_lname": null, "comment_length": 1267}, {"text": "Why are you not going after other patients medications? Start taking medications for those suffering from all other conditions too! SMH!! ", "comment_id": "FDA-2016-D-0785-0033", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0033", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 141}]}, {"id": "FDA-2004-P-0085", "title": "To Request Specific Action on the Regulation of Generic Transdermal Fentanyl Delivery System & to Request Similar Attention to New Product Approvals for Transdermal Fentanyl Products-CLOSED", "context": "2021-09-01T01:02:10Z", "comments": []}, {"id": "FDA-2008-P-0327", "title": "Abreviated New Drug Application (ANDA) Suitability for Tramadol Hydrochloride Tablets 100 mg-CLOSED", "context": "2022-01-05T01:03:16Z", "comments": []}, {"id": "DEA-2018-0004", "title": "Schedules of Controlled Substances:\nPlacement of Butyryl Fentanyl and\nU\u201347700 Into Schedule I (DEA-478)", "context": "2022-03-22T11:16:58Z", "comments": []}, {"id": "FDA-1994-P-0014", "title": "ANDA Suit for 120 mg Acetaminophen & 12 mg Codeine Tablet-CLOSED", "context": "2021-09-01T18:00:28Z", "comments": []}, {"id": "FDA-2015-P-1004", "title": "Requests that the Commissioner of Food and Drugs make a determination that Aspirin and Codeine Phosphate Tablets USP CIII, 325 mg/15 mg, 325 mg/30 mg, 325 mg/45 mg and 325 mg/60 mg combination drug products are suitable for submission in an ANDA.-withdrawn 11/17/22", "context": "2022-11-17T16:58:13Z", "comments": []}, {"id": "FRA-2019-0071", "title": "Drug and Alcohol Testing of Mechanical Employees\n\n\n", "context": "2022-07-20T14:05:26Z", "comments": [{"text": "The control of alcohol and drug use should be enforced in every workplace and for every type of employee regardless of the type of occupation. There are many jobs in society that should require the responsibility and control of alcohol and druge use. Especially when it comes to mechanical employees or those dealing with more serious responsibilites on the job on as daily basis. In agreement, employees who are testing or inspecting railroad rolling equipment should be covered when it comes to the scope of alcohol and drug regulation. Regulated employees should definitely include any MECH employees in order to make sure that they are covered. If this issue is proposed it would help when it comes to accidents as well as fatal accidents to prevent or keep them from continuing to happen as often and if any do happen, these specific employees would be covered and included. This rule would also not affect environmental resources or increased emissions both directly or indirectly so there should be no reason these employees shouldnt be covered. ", "comment_id": "FRA-2019-0071-0013", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0013", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from Alexandra Canaveral", "commenter_fname": "Alexandra", "commenter_lname": "Canaveral", "comment_length": 1053}, {"text": "I think this rule is necessary in order to make sure the use of ALcohol and drug is legal and will be regulated in any situation. The Mechanical employees and their rights to the previous acts have t be specified in this follow-up rule in order to make sure their rights of alcohol and drug use are legal and working correctly. This rule is giving clarification to many things involved in the previous acts published.", "comment_id": "FRA-2019-0071-0005", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0005", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from Guangshi(Stone) Chen", "commenter_fname": "Guangshi(Stone)", "commenter_lname": "Chen", "comment_length": 417}, {"text": "I support this proposed rule. The opioid epidemic has become larger than we could've ever predicted and it's a sickness that needs attention and availability. This proposition to expand coverage and redefine regulation is a step in the right direction to addressing the issue directly and transparently.", "comment_id": "FRA-2019-0071-0010", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0010", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from Joshua Cruzado", "commenter_fname": "Joshua", "commenter_lname": "Cruzado", "comment_length": 311}, {"text": "This proposed rule follows basic common sense on this issue. The rule protects railway workers, engineers, and others as well as the general public. According to the rule, it also saves millions of dollars per year through its deterrence effects. This is a logical step to take to expand the FRA's Congressionally mandated program. It is important for those who are inspected rolling equipment to be in the most sober state of mind they can be while performing their duties, lest they risk not only their own lives, which is commented on in the proposed rule, but the lives of those in the general public if they fail to adequately perofrm their testing/inspection duties due to a substance abuse disorder. ", "comment_id": "FRA-2019-0071-0011", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0011", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 711}, {"text": "The work that the people do benefit the country so making it to where the people working the trains and insure that it works properly is beneficial so that they can do the work correctly so that commerce and public transport keep on flowing so the country keeps up with the demand of products needed.", "comment_id": "FRA-2019-0071-0009", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0009", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from ashtyn bombala", "commenter_fname": "ashtyn", "commenter_lname": "bombala", "comment_length": 300}, {"text": "See the attached file.", "comment_id": "FRA-2019-0071-0003", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0003", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from NTSB", "commenter_fname": null, "commenter_lname": null, "comment_length": 22}, {"text": "Comments related to Docket No. FRA-2019-0071
Safety-sensitive jobs in relation to Medicinal cannabis use has been a hot topic in legislation. I was recently asked how it made me feel to be an advocate and so open about my medical cannabis treatment? How has it affected my life?
I chose to become a nurse because I love to take care of people. It's my passion and gives me purpose, to care for others and uphold the oath that I took. I have been left with this hollow feeling inside accompanied by waves of mourning and frustration. I continue to advocate for those like myself who either can't Medicate or suffer the repercussions of it.
When the topic comes up how's it affected my life and others seek to help me find solutions to my problem my response is usually to this effect:
I couldn't continue to contribute to the decline of the quality of life of Oklahoman’s at the hands of Oklahoma healthcare in order to obtain a paycheck all the while being scrutinized for my methods of medicating which is much safer and effective when properly maintained and managed. One mistake and a positive drug test for metabolites would immediately flag me for drug abuse and treatment and have to go before the board of nursing in order to gain back licensure.
I was passive-aggressively threatened by an employer whenever I brought up cannabis use for the patients that I was caring for and that we should be supporting them and educating them. I mentioned that there's a degree of liability here as well. The response I was given was nurses who medicate are the only liability so I nodded my head and turned in my resignation letter 3 days later due to extenuating personal circumstances as well.
There are other workforce concerns that go greatly unaddressed while medicinal cannabis remains a negative focal point burn out, lack of adequate sleep, pharmaceuticals etc which completely overlooked.
Stress and each individuals tolerance in managing has a great impact on their work and safety of them and those their work affects.
Programs like Predictive Safety mentioned in the article below should be utilized by employers to monitor changes in ability to perform safely. https://tulsaworld.com/opinion/columnists/lawrence-pasternack-medical-marijuana-and-workplace-safety/article_a55493d6-fed6-522e-b743-191002d46d71.html
Consider the following about stress and as an example the effects of working under safety sensitive conditions.
According to The American Institute of Stress:
About 33 percent of people report feeling extreme stress
77 percent of people experience stress that affects their physical health
73 percent of people have stress that impacts their mental health
48 percent of people have trouble sleeping because of stress
Those in safety sensitive positions should be able to medicate freely on their own time without fear of judgement or retaliation. Cannabis and all of its metabolites should be removed from workplace drug testing as it is an out dated resource and only contributes to stigma. Our bodies hold onto THC in fat cells while other drugs that cannabis is often compared to metabolize within a few days. The reason our bodies hold onto cannabinoids is simple and inarguable. Our bodies want it, need it even. The presence of metabolize does not indicate that there is an active impairment. The people who fall under this category are in some of the most mentally and physically taxing jobs because they are safety sensitive and would greatly benefit from medicinal cannabis after a long stressful day at work.
According to the report, 15.6% of all nurses reported feelings of burnout, with the percentage rising to 41% of “unengaged” nurses. What’s really interesting as well, is that 50% of nurses who reported feeling burned out also reported that they had no plans to leave their organization—pointing to the importance of supporting and meeting nurses where they are at in the workforce.
PTSD is an occupational hazard for nursing. It is estimated that up to 14 percent of the overall general nursing population experience symptoms that meet the criteria to be diagnosed with PTSD, which is 4 times higher than the general adult population.
The stigmatic bias and disregard for the many medicinal qualities of cannabis by many of our leaders is the root of the problem.
I am a nurse and patient and have seen and heard hundreds of testimonies from people some would consider to not be using medicinally.
The fact is that medicinal cannabis is the most safe and effecive treatment option for most of the people who medicate. These people have tried traditional methods of treating their problems only to end up with more complications both short term and long term.
As a medical professional it is of utmost importance that I hold tight to my oath to cause no harm and continue to advocate for medicinal cannabis use where it is applicable and reasonable.
", "comment_id": "FRA-2019-0071-0008", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0008", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from Kara McCurry", "commenter_fname": "Kara", "commenter_lname": "McCurry", "comment_length": 5113}, {"text": "Given that railroads have such an impact on our nation and communities via general transportation and supporting our economic system. It is obvious that the FRA should expand its scope of alcohol and drug regulation to cover mechanical (MECH) employees who test or inspect railroad rolling equipment. Also, the fact that two MECH employees have passed due to related events furthers the argument that something needs to be done.
", "comment_id": "FRA-2019-0071-0016", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0016", "comment_date": "2021-03-15T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 434}, {"text": " DOCKET NO. FRA-2019-0071
Posted by the Federal Railroad Administration (FRA)
Control of Alcohol and Drug Use: Coverage of Mechanical Employees and Miscellaneous Amendments
Section: II Mechanical Employees, Contractors, and Subcontractors
Dear FRA,
I am writing regarding the proposed rule revisions to FRA Regulations (49 CFR, Part 219). This rule will require random alcohol and drug testing to expand to contractors and subtractors working in the Maintenance of Way (MOW). Before June 12, 2017, only the regulated mechanical employees required pre-employment, post-accident, and random drug and alcohol testing. I support the revisions because these contractors are equally responsible for inspecting the railroad equipment and tracking their signal and communication systems. Train accidents are happening every 3 hours in our country. This data covers railroad employees, distracted drivers, and lack of proper warning signals for pedestrians and drivers.
When an employee becomes involved in a railroad accident, they must provide a specimen within 4 hours unless immediate medical treatment is required. If the worker is delayed based on injuries, an on-duty supervisor must provide documentation to the administration explaining such. The different agencies can go to the FRA website to view the mandated requirements for stand-alone or random drug and alcohol testing. These random screenings are performed quarterly on their roadway workers. The testing is divided into two separate categories, 50% involves testing for drugs and the other 25% involves testing for alcohol usage for annual records.
In closing, my position remains to support the proposed rule that alcohol and drug screening be expanded to "all" roadway workers. Hopefully, this will eliminate some percentage of tragic accidents that we often hear about regarding individuals losing their lives or life-threatening injuries, trying to "outrun" a train when approaching the railroad tracks. The clients in my treatment program are placed on a daily call-in for random drug and alcohol screening. The outcome of relapsing seems to decrease in numbers because of accountability. Therefore, the duties of a railroad worker who repairs our bridges, tracks, and roadways should be accountable for the safety of keeping themselves, our citizens, and co-workers unharmed if preventable. ", "comment_id": "FRA-2019-0071-0018", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0018", "comment_date": "2021-04-13T04:00:00Z", "comment_title": "Comment from Helen KING", "commenter_fname": "Helen", "commenter_lname": "KING", "comment_length": 2457}, {"text": "I am for this proposed rule since it provides a safer work environment for mechanical employees. If I was an employer, I wouldn't want my employees to the intoxicated or under the influence while dealing with machinery or equipment. It can lead to accidents especially if the equipment was dealt with improperly. Under executive summary, It explains incidents that led up to the revision of alcohol and drug regulation. These incidents either caused an injury or death for mechanical employees. If frequent drug tests became a necessary precaution, it will help prevent these kinds of incidents from increasing. ", "comment_id": "FRA-2019-0071-0015", "comment_url": "https://api.regulations.gov/v4/comments/FRA-2019-0071-0015", "comment_date": "2021-03-10T05:00:00Z", "comment_title": "Comment from Nadia Legorreta", "commenter_fname": "Nadia", "commenter_lname": "Legorreta", "comment_length": 618}]}, {"id": "FDA-2014-N-0233", "title": "Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics; Request for Comments", "context": "2014-08-22T11:57:35Z", "comments": [{"text": "See attached file(s).", "comment_id": "FDA-2014-N-0233-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0014", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from Oncology Nursing Society (ONS)", "commenter_fname": null, "commenter_lname": null, "comment_length": 21}, {"text": "The Notice seeks commentary on PREVENTING ACCIDENTAL USE by someone for whom the medication was not prescribed. This is a critically-important objective because opioids are currently the number one cause of child poisonings in the US, even with the implementation of universal child safe dispensing.
Divert-X – the dispensing and behavioral monitoring system under development by Vatex – tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms. Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients. A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.
Divert-X packaging is assembled in pharmacies in order to have a broad impact. A dispensing system must be agnostic to dose, dosage form, and manufacturer to cater for all the forms of Controlled Substances that are diverted and misused. The broad applicability of Divert-X will greatly assist its adoption if shown to be effective. Unit dose packaging that meets F1 level requirements will be suitable for packaging any medication regardless of toxicity. Based on current Poison Prevention Packaging Act (PPPA) criteria (1-2), a blister system certified to an F1 level is far safer than a certified pharmacy dispensing bottle (assuming both fail). Specifically, if F1-certified packaging fails, then a single dose is available to a child; conversely, if a pharmacy dispensing bottle fails, then the entire contents are available to the child. Hence, blister systems have a role in opioid safety because opioids are currently the number one cause of child poisonings in the US, even with the implementation of universal child safe dispensing mandates (3). While factory-assembled blister packs have been certified to an F1 level, no child-safe features have been added to any blister system assembled in a pharmacy because no market need has existed to date. The main existing market for pharmacy-assembled blisters is long-term care facilities, and these facilities are exempt from PPPA requirements because their medication management practices are similar to hospitals. All Vatex products will achieve F1 certification prior to commercialization.
The Notice also seeks commentary on packaging approaches to minimize in-home theft of medication by teens, visitors, caregivers, etc. Because blister packaging allows inventory assessment via a quick visual inspection and because blister packaging averts substitution schemes that use lookalike pills, this will have a preventive impact. Additionally, patients using Divert-X can obtain recent dose-removal times via telephone, text message, etc. in order to conduct their own diligence. Most importantly, Divert-X provides strong incentives for returning unused medications soon after they are dispensed. These incentives are the subject of a separate submission to this docket (search for “Safe Disposal”).
Because Divert-X will be challenged by users who are looking to subvert it, the packaging must possess many features to dissuade tampering but highlight it when it occurs. A tamper assessment by the pharmacist is the final step in the Divert-X cycle prior to obtaining a final score. Vatex is advantaged by the fact that the adhesives already in use for in-pharmacy assembly are far stronger than the materials used to make the packaging. Vatex has assessed products from all North American manufacturers of pharmacy-fill cards; in all cases, the cardstock and foils fail when attempts are made to disassemble or subvert a blister card. The strength of the seal itself serves as a child-safety feature. The strength of the seal relative to the materials of construction is a key in making tampering evident. Tamper-resistance features and child-proof features augment each other, and they are tested together under PPPA certification.
The PPPA provides and mandates all details needed for child-resistant package testing, but the packaging must also be useable by senior adults in order to obtain any certification. Hence, the PPPA also provides mandated protocols for determination of the Senior Adult Use Effectiveness score (1-2). The design of PPPA trials, for children and senior adults, are mandated to a very high level of detail, to include items such as the text of all allowable verbal interactions between testers and participants, the text of consent forms to be used, and scoring requirements. All Vatex products will achieve F1 certification prior to commercialization.
[please see the accompanying PDF attachment to view the references]", "comment_id": "FDA-2014-N-0233-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0012", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from Vatex Explorations, LLC", "commenter_fname": null, "commenter_lname": null, "comment_length": 4899}, {"text": "See attached file(s)", "comment_id": "FDA-2014-N-0233-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0018", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from Generic Pharmaceutical Association (GPhA)", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attachment", "comment_id": "FDA-2014-N-0233-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0028", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from Pharmaceutical Care Management Association (PCMA)", "commenter_fname": null, "commenter_lname": null, "comment_length": 14}, {"text": "The problem with opioids is not, generally speaking, a problem to be solved with technology. The problem is that there are too many legal opioids, and that physicians are too quick to prescribe them:
- One in seven pregnant women has been prescribed an opioid at some point during her pregnancy (http://www.medpagetoday.com/PainManagement/BackPain/44603)
- Nearly 50 percent of adolescents who visit a doctor complaining of a headache receive a prescription for one or more narcotics (http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/44647)
- More than 25 percent of Americans who use opioids for non-medical indications 200 or more days per year have been prescribed these drugs by a doctor (http://www.upi.com/Health_News/2014/03/03/Prescription-painkiller-abusers-often-get-them-from-a-doctor/UPI-70241393880460/)
With the average doctor visit lasting less than 20 minutes (http://www.asrn.org/journal-world-news-nursing-report/7-average-doctor-visit-grows-by-32-seconds-over-10-years.html), many physicians don't feel they can take the time to discuss pain management strategies -- or lifestyle changes -- with patients who visit them complaining of chronic pain. The situation is even worse in emergency rooms, where doctors may prescribe painkillers to addicts just to clear the decks for true emergency patients. Approving more painkillers -- opioid analgesics and others -- is only going to make it easier for doctors to take the easy way out and prescribe them for people who could solve their pain problems another way.
Creating a new surveillance state, in which people prescribed pain medication are tracked, is not the solution. There is little enough medical privacy in this country. The FDA seems to think that it can make everyone happy by making dangerous drugs plentiful (nice payout to pharmaceutical firms) and then handing out naloxone auto-injectors for when things go wrong. Sometimes, the right answer is to do less: approve fewer pain drugs, prescribe pain drugs less often, track fewer patients. Ask people to manage their pain in other ways -- lose the weight that is causing the back pain, take the physical therapy that will make movement less painful, go through a pregnancy without the lifestyle drugs that will harm your baby. ", "comment_id": "FDA-2014-N-0233-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0005", "comment_date": "2014-05-02T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 2317}, {"text": "Please see attached executive summary report (PDF format) and associated spreadsheet (Microsoft EXCEL format).", "comment_id": "FDA-2014-N-0233-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0006", "comment_date": "2014-05-28T04:00:00Z", "comment_title": "Comment from Luis Zuluaga", "commenter_fname": null, "commenter_lname": null, "comment_length": 110}, {"text": "Please see the attached comments of the National Association of Chain Drug Stores regarding Public Docket No. FDA–2014–N–0233; “Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics.”", "comment_id": "FDA-2014-N-0233-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0009", "comment_date": "2014-06-05T04:00:00Z", "comment_title": "Comment from National Association of Chain Drug Stores", "commenter_fname": null, "commenter_lname": null, "comment_length": 274}, {"text": "The Notice seeks information on the EFFECTIVENESS and ACCEPTABILITY of interventions that can be applied to reducing the prescription drug crisis. Vatex leverages established behavioral science to reduce diversion and misuse of Controlled Substances.
Divert-X – the dispensing and behavioral monitoring system under development by Vatex – tackles this problem directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms. Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients. A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.
The theory of action for our efforts is straightforward and evidence-based: checks & balances for oversight of psychoactive, addictive drugs promote thoughtful use, safer behaviors, and accountability. The Vatex hardware advancements are described in a separate submission to this Docket (search for “Hardware Design”) and are used to gather objective data on actual medication-use behaviors. These objective data are currently unavailable for individual patients. The application of proprietary analytics for assessing behavioral markers collected by the packaging is used in a management system designed to reduce diversion and misuse. The management system is termed “Active MTM” and is described in a separate submission to this Docket (search for “Management Systems”).
Several behavioral “big data” analogies to the Vatex approach exist. For example, insurers use real-time analytics to remotely uncover dishonest doctors and prevent “pay and chase” schemes (1). Brick-and-mortar and online casinos use real-time analytics to intervene in gambling addiction (2). Efforts of online gambling companies to identify problem gamblers are directly analogous to Divert-X because all data are collected remotely, in real-time, in fine detail, and are related to addiction (2-6). Another analogy is the proprietary credit scoring systems used by the consumer finance industry known as debt-repayment risk algorithms (7-9). The study of hidden human behavior has become central to several subfields of economics and finance (10). Because of this longstanding research focus, the behavioral and economics literature has firmly established that people are more accountable for their actions when they are being scored or merely aware that they might be scored (10-30), but the scoring system must remain somewhat opaque so that it is not subverted. For example, details of banking algorithms (used to score customers and employees) are tightly-held secrets (10). Similarly, the detailed methodology behind medication-use scoring will not be shared with the public generally in order to leverage behavioral science and to protect from subversion.
Vatex sees strong parallels between the human desire to be seen as a good credit risk (rewards include improved loan pricing, employability in high-value positions, lower insurance rates (31-32)) and the desire to be seen as a credible patient (rewards include enhanced trust between provider and patient, straightforward access to needed medications, improved care quality). Bringing trust back to Controlled Substance prescribing and reducing patient-access disparities are key long-term Vatex goals. Employing a sophisticated device as an integral part of dispensing will emphasize to the patient, the family, and caregivers the serious safety risks associated with Controlled Substances. Because many people do not understand the risks of their medications, the packaging itself serves to warn (a behavioral “nudge” (33)) and should result in greater caution being taken to comply with prescribed regimens. Hence, the Divert-X packaging emphasizes safe-use and educational principles.
Precedent from the medical, behavioral, and economics literature show that Divert-X is likely to be a high-impact system. Vatex is combining key refinements of historical systems with its own innovation to address a pressing problem. The medical literature is replete with studies (34-37) showing that compliance to medications not regulated by DEA can be increased through a variety of actions with corresponding improvements in health and cost. Improving compliance to Controlled Substance regimens is much more challenging, however, because overconsumption is spurred by experimentation and addiction, because of the financial windfall for those patients who divert their ongoing prescriptions (38-43), and because current clinical tools cannot separate authentic patients from those exaggerating the intensity and duration of disease (44-49). Hence, the literature describing methods that improve Controlled Substance adherence is sparse. A single Europ [please see the PDF provided for the full version with references]
", "comment_id": "FDA-2014-N-0233-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0013", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from Vatex Explorations, LLC", "commenter_fname": null, "commenter_lname": null, "comment_length": 5135}, {"text": "The Notice seeks information on PAYER INCENTIVES and the feasibility of implementation of interventions that can be applied to reducing the prescription drug crisis. Innovative packaging that reduces opioid misuse can generate significant economic benefit by reducing the excess medical costs consequential to abuse and fraud. Outcomes improving financial returns for private and public healthcare payers will drive implementation of an evidence-based drug safety system.
Divert-X – the dispensing and behavioral monitoring system under development by Vatex – tackles prescription medication abuse by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms. Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients. A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.
The insurance community - private, Medicare, Medicaid, workers’ compensation, self-insured employers, and VA - will be the customer base for Divert-X. The market for an IT service to infer patient behavior towards opiates and other Controlled Substances and to provide actionable information must be developed. Vatex expects that data from Divert-X pilots will successfully demonstrate the identification of anomalous patient behaviors and reduction in the misuse and diversion of medications. This will allow an estimate to be made quantifying the economic benefit from the introduction of Divert-X. The economic outcome will be used to petition medical insurance companies and government payers that the use of the system will generate significant healthcare savings for their organizations.
Currently there are no technology-driven methods to differentiate between legitimate opiate patients and those abusing and diverting. Without effective tools, medical practice involving Controlled Substances has devolved to speculative, ineffective patient profiling (1-5), spawning numerous lawsuits and administrative actions (6-9), documented discussion of how to lie to patients (10-12), public battles between pharmacy and physician groups (13-15), and uncertainty expressed by DEA in court regarding how to establish the legitimacy of prescriptions (16). In the 2011 Government Accounting Office publication ‘Prescription Pain Reliever Abuse’ (17), DEA officials report that “based on the available prescription and sales data, there is no method to calculate which prescriptions are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and which are not.” As a result of the inability to identify and take broad action against diverters, the DEA increase their quota for opiate and Controlled Substance production based on demand- which naturally includes diverted medications. The recent Compounded Annual Growth Rates for opiate and stimulant DEA quotas are a staggering 27.0% and 33.4% respectively (18-19). Because Divert-X establishes dose-level accountability, it will reduce fraud, street medication supply, and diversion. It will provide an objective means to identify patients who are misusing opiates and other Controlled Substances and provide a novel method to combat the epidemic.
The Vatex sales channel will be direct to insurers. We expect that insurers will mandate the use of Divert-X for opiates and other Controlled Substances for their patient populations once they are convinced of the magnitude of savings that it will generate. The high volume of Controlled Substance prescribing will ensure that pharmacies are responsive to the dictates of health insurance payers to dispense using Divert-X. In order to facilitate the cooperation of pharmacies, the Divert-X device is designed so that it can be filled in a very efficient manner with only a moderately longer pharmacy process. A dispensing fee for Divert-X will be paid to the pharmacy that is in excess of and in addition to standard medication dispensing fees. Divert-X adoption will therefore create a new source of revenue for the pharmacy, which will facilitate co-operation.
Extrapolation from a 2007 insurance industry estimate (20) suggest that opiate misuse results in at least $100 billion in excess annual medical costs for insurers driven by the costs of emergency room visits, increased physician visits, diagnostic and drug-test spending, falls and other accidents, and abuse treatment programs. When this economic burden is considered against the annual volume of 200 million opiate prescriptions, abuse and fraud can be estimated to cause an average hidden cost burden of $500 in excess medical spending added to every prescription. Vatex’ corporate goal is to reduce Controlled Substance misuse and [please see the PDF provided for the full version with references]", "comment_id": "FDA-2014-N-0233-0022", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0022", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from Vatex Explorations, LLC", "commenter_fname": null, "commenter_lname": null, "comment_length": 5080}, {"text": "Friday, June 6, 2014
Colleen Brennan, Center for Drug Evaluation and Research
Office of Surveillance and Epidemiology
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 22, Rm. 4410
Silver Spring, MD 20993-0002
Re: Docket No. FDA–2014–N–0233; “Use of Innovative Packaging, Storage, and/or
Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics”
Ms. Brennan,
PillGuard Medication Delivery Systems appreciates the opportunity to comment on innovative packaging, storage, and disposal systems, technologies or designs (“designs”) that could be used to prevent or deter misuse and abuse of opioid analgesics by patients and others.
In 2003, Dr. Robert Muncy and I were discussing the widespread abuse of controlled prescription medications in areas of Kentucky. As doctors, we were concerned that legitimately prescribed medications were being diverted and abused in many ways. Hoping to help alleviate the complex problems and the human tragedy associated with the widespread and growing abuse of dangerous prescription drugs, we wanted to create a device that would both reduce current levels of prescription drug abuse, and help prevent future abuse of prescription medications. Moreover, we wanted to increase public health and safety in our communities. We further realized that both our state and federal governments could benefit from a reduction in the skyrocketing costs for law enforcement, criminal justice, health care, and social services associated with prescription drug abuse. We saw a need for a better-protected pill bottle designed to prevent diversion of dangerous medications and took the idea to the University of Kentucky Center for Manufacturing.
Powerful prescription medications can be life saving when taken under the supervision of a physician, but when abused, they can be just as life threatening as illicit drugs. The team concluded that the new kind of pill dispenser envisioned by the doctors should be one that: (a) would allow dispensing of a prescribed medication only in the prescribed amount no faster than the prescribed rate; (b) would detect tampering if someone were to try to break open the container or to otherwise forcibly remove the medication early; and (c) upon detection of tampering, pharmacists could be alerted.
The PillGuard medicine dispenser will address the prescription drug abuse problem by allowing doses of dangerous drugs only at carefully regulated times. Controlling the time of delivery for addictive medication will deter over dosage and criminal action. Misrepresenting the facts and current state of our company, commenter Divert-X (ID: FDA-2014-N-0233-0010) indicated that our company closed in early 2014 due to reimbursement factors. On the contrary, this past week we launched a pilot program at the James A. Haley Tampa VA Medical Center to demonstrate the effectiveness of the device on our nation's veterans. The Department of Veterans Affairs likely recognizes the immense danger to the "take as needed" approach and attributes that approach to the growing issue of abuse of controlled substances.
While PillGuard, other limited access devices, tamper-resistant formulations, smart blister packaging, dispensing and behavioral monitoring systems, and other abuse deterrent technologies will not likely eliminate our nation's prescription drug abuse problem, they can deter a large percentage of illegal abusers. With more assurance that the patient will not take their pills more frequently than prescribed or sell them all on the street, physicians can be more willing to prescribe these highly addictive medications when they will improve the patient’s health. The attachment recommends specific device characteristics and addresses several of the topics of interest.
We thank the FDA for allowing us to comment on this important matter and pledge our support to the FDA in fighting this national epidemic.
Sincerely,
Dr. Anthony McEldowney
CEO, PillGuard Medication Delivery Systems
(304) 514-9426
anthony.mceldowney@rammllc.com
", "comment_id": "FDA-2014-N-0233-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0019", "comment_date": "2014-06-16T04:00:00Z", "comment_title": "Comment from PillGuard Medication Delivery Services", "commenter_fname": null, "commenter_lname": null, "comment_length": 4236}]}, {"id": "FDA-2019-P-1643", "title": "Requests that the FDA immediately impose a moratorium on all future approvals of new drug applications (NDAs) for new opioids or new opioid forumulations.-WITHDRAWN 4/10/19", "context": "2019-04-11T12:44:20Z", "comments": []}, {"id": "FDA-2007-P-0124", "title": "ANDA Suitability for Hydrocodone Bitrartrate and Homatropine Methylbroomide Tablets, 2.5 mg / 0.75 mg - Closed", "context": "2021-09-01T01:01:00Z", "comments": []}, {"id": "DEA-2017-0005", "title": "Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl into Schedule I", "context": "2021-12-02T01:00:52Z", "comments": []}, {"id": "FDA-2016-P-4094", "title": "Request that the FDA to (i) require proposed generic versions of Intranasal (IN) naloxone products to provide specific pharmacokinetic (PK), device, stability and Chemistry, Manufacturing and Controls (CMC) data, as set-out herein, within the ANDA, to support the interchangeability of generic IN naloxone and the IN naloxone Reference Listed Drug (RLD); (ii) not to approve any", "context": "2017-05-30T11:27:51Z", "comments": [{"text": "See uploaded file. ", "comment_id": "FDA-2016-P-4094-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-4094-0004", "comment_date": "2017-05-30T04:00:00Z", "comment_title": "Comment from Erin", "commenter_fname": null, "commenter_lname": null, "comment_length": 19}, {"text": "See attached file(s)", "comment_id": "FDA-2016-P-4094-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-P-4094-0005", "comment_date": "2017-05-30T04:00:00Z", "comment_title": "Comment from Suki Iyer", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}]}, {"id": "DEA-2014-0005", "title": "Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II", "context": "2022-03-22T11:18:07Z", "comments": [{"text": "The proposed rescheduling of hydrocodone will place a large time-consuming burden on physicians and will result in a larger number of pills available for diversion. I am a Plastic,Reconstructive, & Hand surgeon in Lufkin, a small city in rural Deep East Texas. I am very busy, working at least 70 hours each week. Burns and hand & arm surgery particularly, with crush injuries from the heavy steel manufacturing and logging industry, are associated with signficant pain. It is my general policy to initially prescribe a small number of pain pills (30) following surgery. It is also my belief that one doesn't get any extra points for suffering, so if a patient has pain then I certainly wish to alleviate his suffering. I am presently president of the medical staff at Woodland Heights Hospital, recent president of the County Medical Society, former president of the medical staff at Memorial Medical Center, and I sit on the bylaws committees of both hospitals. I have been a delegate to the Texas Medical Association twenty times in my 25 year career in this same location. That is mentioned only to emphasize that I am not a crack-pot, I am a well respected member of the medical community. If a patient requires a refill, I can currently pick up the phone and speak to the pharmacists I know by name and quickly provide a refill. If hydrocodone is made schedule II, then I must instead write a prescription, make it accessible to the patient to pick up and carry to the pharmacist, or I must carry it to the pharmacy and drop it off. Forty percent of my patients live farther away from Lufkin than forty miles. Given the increased difficulty for me to refill the prescriptions I promise you that I will make my initial prescription in all cases at least 60 tablets. Not all of them need a re-fill, I assure you of that; but, a significant number do, and it would be such a hassle trying to get patients from Jasper, Newton, Onalaska, Cleveland, Shepherd, Livingston, Crockett, Grapeland, etc their prescription refills, therefore I promise you I will provide larger numbers up front. Unused pills sitting around are likely to be diverted. Please do not make my life more complicated, my patients truly in pain suffer more, and especially do not create your unintended consequence of MORE pills being diverted. Houston is not the same as Lufkin, and Washington DC is not the same as Williston, North Dakota. Please, while sitting in your ivory tower in Washington, DC, try to imagine how it is in rural areas of East and West Texas, Wyoming, or Western North Dakota. Enclosed is a photo of a map in my office. I have had at least one patient come from each dot on the map. Some of them have come for elective surgery, many in East Texas and Louisiana because they were injured. How in the world do you expect me to get their schedule II scripts to them at 8:00 pm at night? ", "comment_id": "DEA-2014-0005-0102", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0102", "comment_date": "2014-03-13T04:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "William", "commenter_lname": "Strinden MD", "comment_length": 2937}, {"text": "See attached file(s)", "comment_id": "DEA-2014-0005-0295", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0295", "comment_date": "2014-04-25T04:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 20}, {"text": "On first thought, I support changing to schedule 11 as hydrocodone by itself is schedule 11. However does this also apply to the cough syrups that have a small quantity of hydrocodone? Just which combinations would be involved?", "comment_id": "DEA-2014-0005-0019", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0019", "comment_date": "2014-02-28T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "anonymous", "commenter_lname": "Anonymous", "comment_length": 229}, {"text": "Re: Docket No. DEA-389
I am asking you to reconsider making hydrocodone a CII drug. I have arthritis in my cervical spine and this medication offers some relief from the terrible pain. I have been taking this drug for 2 years and don't believe that I am a public or personal threat to myself or to others. I am prescribed 90 tables per month, but typically don't take them all. I take them only as needed. I feel that me and other patients like myself who are not abusing hydrocodone and are taking it as prescribed, are being singled out and punished just because others are abusing this drug. People will abuse any drug, if they are so inclined.
If you make this drug a CII, I will have to get a new prescription each time, meaning that I will have to see my doctor each time and pay for an office visit each time. I am have very limited income and a high insurance deductible, so this will very difficult for me to do. Please, consider the patients that truly need this drug and who are not abusing or diverting it to others before making this decision that will impact my medical bills.
Thank you. ", "comment_id": "DEA-2014-0005-0043", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0043", "comment_date": "2014-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Jennifer", "commenter_lname": "Williams", "comment_length": 1150}, {"text": "I believe that hydrocodone products should be moved to C2 medications because too many people are abusing it because it is more available ,also it has big potential for abuse", "comment_id": "DEA-2014-0005-0039", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0039", "comment_date": "2014-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 174}, {"text": "As a community pharmacist for 16 years and now a faculty member in a college of pharmacy teaching pharmacy law, I see several unintended consequences of moving hydrocodone combination products from CIII to CII status. These include the following:
1. Drug of choice prescribed will change from hydrocodone combination products to some other CIII medications like codeine codeine combination products, Suboxone and Subutex (which have off-label uses for pain) and other CIII pain medications. This really isn't solving the abuse problem -- it is just shifting the problem to another drug.
2. This change will put increased hurdles on patients and pharmacists for those with legitimate pain and have a legitimate reason for using the medication.
3. There are already drug shortages for other CII medications because of stop orders that wholesalers are putting on community pharmacies that are impeding those pharmacies and pharmacists abilities to take care of patients with legitimate needs. Moving hydrocodone combination products to CII status will make this situation worse if there is no corresponding changes to this process.
4. We are already seeing an increase in heroin and other CI substance abuse as a result of the decreased availability of oxycontin and other oxycodone containing products. Not sure which is the lesser of the two evils.
I realize that the DEA is an enforcement agency -- I would like to know when the legitimate patient was lost in the big picture. Instead of having health care providers and pharmacists taking care of patients as our primary roles, it seems that the DEA would rather health care providers and pharmacists have our primary role be the "drug police". That is not what I went to pharmacy school for nor do I believe this is what most health care providers went to school for.
In conclusion, I realize why the DEA and FDA think that rescheduling hydrocodone combination products is a good idea. I believe the unintended consequences of the move would actually make the situation worse. Therefore, I respectfully ask that the DEA not reschedule hydrocodone combination products to CII.
Sincerely,
Mary Gurney", "comment_id": "DEA-2014-0005-0038", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0038", "comment_date": "2014-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Mary", "commenter_lname": "Gurney", "comment_length": 2257}, {"text": "I am a nurse practitioner in a state that does NOT allow us to write class II narcotics. For many patients we are their only healthcare provider.
This change will severely affect our patient’s ability to obtain their pain medications. Our practice is in a very rural area where the nearest pain management provider is approximately 1 hour away making it unobtainable for many patients. Many patients cannot make the drive due to cost of gas, cars in poor shape, or lack of family support to take them.
We also have a problem with the pain management providers not accepting all insurances, especially the Medicaid patients.
I do not want to see this rule changed. It will impact the poor, underserved patients the most.
", "comment_id": "DEA-2014-0005-0018", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0018", "comment_date": "2014-02-28T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 768}, {"text": "My name is Deborah. I am 42 years old and live in Alabama. I have a lower spinal birth defect, DDD, spinal stenosis & other painful health issues. For the past 6 years I have been under the care of a neurologist. In order to function I rely on Norco 10/325's, 2 pills per dose, 4 doses per day. I have been on this amount for 3 years & have worked hard to not increase this dosage. I am uninsured. Alabama is a state that refused the medicaid expansion funding allowed via the new National Healthcare Law. What this means to me is that I am in the gap, not enough income to buy a health plan but too much income to qualify for help through my state. I had a hearing to determine if I will be allowed my SSDI benefits 12/18/13 and am still waiting for the decision, If approved there will still be a large gap between approval & when Medicare will cover my medical expenses. I woke this morning to find that the rescheduling of my pain medicine is one step closer to becoming a reality. The impact this will have in my life is enormous so I am writing to give you a glimpse into how this will affect my family. My doctor of 6 years, due to a sanction placed by the state medical board cannot currently write any prescriptions stronger than a schedule lll. At this point I see my doctor 4x a year for appointments. Beginning last December the visits were reduced to $100 but until that point I had paid $175/visit for 3 years and then $250/visit from that point until the recent reduction. The $250 price range is the norm for visits to comparable doctors in my area. I have also done disc decompression that I raised 3/4 of the funding for via a fundraiser. I am making payments on the balance & will be for quite some time. I also pay out of pocket for all of my medications at the cost of $200/month. If this rescheduling goes into effect I will either have to stop treatments completely or switch my care to a new doctor & pay even more for my care. New patient doctor visits cost about $300 & follow up visits are in the $200-250 range. I am aware that the cost involved with obtaining a new prescription each month could run $75 for a urine screen or pick up fee to full visit cost every month. There is no way I can possibly absorb these costs & it may not even be an option to continue my care. When I first heard of these potential new regulations I made a few calls to doctors in my area and each time I mentioned that I am uninsured & require narcotics to maintain my quality of life the roadblock came up. Doctors do not want to take on an uninsured patient, apparently we are a risk whether it be fear of our diverting our medications or the potential that we may need therapy or care that we are unable to afford. I beg of you to consider the impact this rescheduling will have on myself & my family. Being unable to work I rely on family to help with these expenses and it has created a circle where they break their backs only to keep us barely above water. My children will have to watch mom suffer in agonizing pain. Now I am able to walk for short distances & leave the wheelchair for times that the walking is just more than my back & hips can tolerate. As a chronic pain patient I am very aware that some misuse this type of medication. Narcotics were not my first choice nor one I wanted but the only other medication that somewhat helped is a medication called Ultram. I tried it but it made me drunken, loopy & unable to function, I fell several times while taking it. I am at risk for having seizures if I ever take it again. I take my medication as directed & humbly give urine screens & pill counts when asked, I keep my medication under lock & key & don't even let people know I am on this medicine for fear of my safety if those who are addicted find out I am prescribed this. I can't even "rally the troops" so to speak via social media to encourage others to speak out for fear of those addicted knowing I have access to this narcotic & additionally, my pain contract forbids my sharing that I take this medication. It may be hard to imagine having no health insurance, if you are reading this letter you probably have it; but please try to imagine how drastically this will impact my life if it does go into effect. PLEASE, I beg of you, don't take my quality of life away. I have so much to offer to my family and children and society but I can't if I am in such pain that I can't function. My pain without intervention is so bad that I am unable to even think coherently & become severely depressed. I have cried buckets wondering how I can help myself maintain what little quality of life I have. PLEASE don't punish me and my family for actions of those who acquire these drugs illicitly & harm themselves. I've done everything required to show I do not misuse/divert my medicine. Abusers don't care about the law & will just find another substance to abuse. I have my pride, I have never begged for anything but I BEG you. If not for me, please, for my children.", "comment_id": "DEA-2014-0005-0022", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0022", "comment_date": "2014-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Deborah", "commenter_lname": "Anonymous", "comment_length": 5126}, {"text": "I think this is a great idea. I work with addicted adults and teenagers, and think this move will help put these drugs more out of their reach. You will always get people who are addicted to any opioids, but the harder you make it to get them, the better.", "comment_id": "DEA-2014-0005-0033", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0033", "comment_date": "2014-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 257}, {"text": "As a practicing physician, pain medications are a powerful (yet potentially dangerous) tool to assist my patients. Unfortunately those choosing to divert medications to unintended uses dilute my ability to provide safe and effective treatment to patients.
I am IN FAVOR of moving hydrocodone-containing medications into Schedule II drug category to: 1) allow me to continue providing safe and effective therapy where appropriate; 2) improve surveillance on appropriate prescribing, dispensing, and utilization of these medications; 3) improve law enforcement and judiciary support to licensed prescribing physicians; 4) providing law enforcement and judiciary with enhanced mechanisms to stiffle illegal prescribing, use, and diversion of hydrocodone-containing substances.
Hydrocodone medications have been Schedule III drugs and despite that level of oversight, drug diversion has demonstrably and consistently increased. Drug diversion is a HUGE public safety issue and the Federal Government is tasked with provision of measures to protect US citizens; albeit sometimes from their own misadventures.
In dispatching its Public Safety mandate, the US DEA must move hydrocodone into Schedule II.
", "comment_id": "DEA-2014-0005-0028", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2014-0005-0028", "comment_date": "2014-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2014-04333", "commenter_fname": "Michael", "commenter_lname": "Elston", "comment_length": 1228}]}, {"id": "FDA-2003-P-0276", "title": "Abbreviated New Drug Applications (ANDAs) Suitability for Hydrocodone Bitartrate-CLOSED", "context": "2021-09-01T01:03:05Z", "comments": []}, {"id": "FDA-2005-P-0009", "title": "ANDA Suitability for Oxycodone Hydrochloride, 7.5 mg Tablets, USP-CLOSED", "context": "2021-09-01T01:01:11Z", "comments": []}, {"id": "FDA-2018-D-1334", "title": "Opioid Dependence: Developing Depot Buprenorphine Products for Treatment", "context": "2019-02-07T10:53:56Z", "comments": [{"text": "With our rapidly changing society and health care system, opioid addiction has become a major problem all over the United States. The use of depot buprenorphine is one solution to help in decreasing opioid dependence. With the trial being a controlled, blinded study testing the doses seemed to prove to help. The patients that were tested with different characteristics such as new participants to treatment, the already stable patients like if the patient has a relapse, and patients that are not very like to prove effectiveness. Patients that are being seen at least weekly help to keep the studies current and allow for adjusting the dosages to better help to decrease the dependence on opioids. Since they are being checked weekly, it helps to build rapport with the patients making them more willing to come forward with what opioids they may have taken. The endpoints for patients help to better determine the studies effectiveness. With the reduction of cravings, improvement in sleep or mood, or other reported outcomes better helps to demonstrate the benefit of the depot buprenorphine. With the information about cravings, sleep, and mood this could lead to more products like buprenorphine being approved. One study done that was randomized with 428 participants. Forty-eight participants had a reaction at the injection site. With the buprenorphine 17.4% had a good response and 14.4% had a good response with the placebo. (Lofwall & et. el, 2018) If this only helps a few people with opioid dependence it would be worth it. Plus with more studies done it can help even more.
Lofwall & et el. (2018). Weekly and monthly subcutaneous buprenorphine depot formations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: a randomized clinical trial. JAMA Inter Med. 1;178(6):764-73. doi: 10.1001/jamainternmed.2018.1052.", "comment_id": "FDA-2018-D-1334-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1334-0005", "comment_date": "2018-07-06T04:00:00Z", "comment_title": "Comment from Emily Schindler", "commenter_fname": null, "commenter_lname": null, "comment_length": 1880}, {"text": "See attached file(s)", "comment_id": "FDA-2018-D-1334-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1334-0004", "comment_date": "2018-07-06T04:00:00Z", "comment_title": "Comment from Indivior", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "FDA-2018-D-1334-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-D-1334-0003", "comment_date": "2018-07-06T04:00:00Z", "comment_title": "Comment from Anthem, Inc", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}]}, {"id": "SAMHSA-2022-0002", "title": "Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) (Revised)", "context": "2022-06-14T14:07:49Z", "comments": [{"text": "Federal workers should absolutely be allowed use medical marijuana with a doctors recommendation just as they can use any other controlled substance with a valid prescription. The a huge portion of federal employees are disabled veterans and should be allowed to use medical marijuana if their doctor deems it an appropriate treatment.
The War on Marijuana is an ridiculous and it’s even more ridiculous that the federal government is proposing this language, as congress is moving towards completely removing cannabis from the controlled substance list. Stop discriminating against federal employees as the majority of states allow medical marijuana and it general direction is towards recreational legalization.", "comment_id": "SAMHSA-2022-0002-0003", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0003", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06884", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 728}, {"text": "Medical cannabis is legal in 37 states, there are many doctors and medical professionals that realize the benefits of cannabis. The federal government is completely out of touch with the American people on the benefits of medical cannabis, and it should be up to a doctor and their patient on its use. I find it disturbing that the Federal government wants to continue the use of urinalysis on their employees, current or prospective, to detect cannabis use when it does not detect intoxication. Continuing to test current or prospective federal employees for cannabis use limits the applicant pool, and will force current employees to retire early, or move to the private sector rather than continue this policy.", "comment_id": "SAMHSA-2022-0002-0004", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0004", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment from John Wurm", "commenter_fname": "John", "commenter_lname": "Wurm", "comment_length": 753}, {"text": "See attached file(s)", "comment_id": "SAMHSA-2022-0002-0006", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0006", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment from Markita Norman-Green", "commenter_fname": "Markita", "commenter_lname": "Norman-Green", "comment_length": 20}, {"text": "Comments of Airlines for America attached.", "comment_id": "SAMHSA-2022-0002-0012", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0012", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 42}, {"text": "See attached file(s)", "comment_id": "SAMHSA-2022-0002-0011", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0011", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "The comments of Laboratory Corporation of America Holdings (Labcorp) are attached.", "comment_id": "SAMHSA-2022-0002-0010", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0010", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 82}, {"text": "See attached file(s)", "comment_id": "SAMHSA-2022-0002-0026", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0026", "comment_date": "2022-06-14T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06884", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "SAMHSA-2022-0002-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0027", "comment_date": "2022-06-14T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06884", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached", "comment_id": "SAMHSA-2022-0002-0018", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0018", "comment_date": "2022-06-14T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06884", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "See attached", "comment_id": "SAMHSA-2022-0002-0020", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0002-0020", "comment_date": "2022-06-14T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06884", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}]}, {"id": "FDA-2013-P-0995", "title": "Refuse to File any 505(b )(2) New Drug Application (NDA) for a Buprenorphine/ Naloxone Drug Product Consisting of a Polymer Film for Application to the Oral Mucosal Membranes Unless Such 505(b )(2) NDA References NDA No. 22-410 (SUBOXONE\u00ae)-CLOSED", "context": "2013-09-25T10:29:17Z", "comments": []}, {"id": "ONDCP-2020-0001", "title": "Designation of Emerging Drug Threats in the United States ", "context": "2022-06-22T12:26:41Z", "comments": [{"text": "The United States has failed to recognize or act upon marijuana as a drug threat, despite clear violation of international treaties. The health harms are more apparent and societal and environmental harms will outstrip alcohol and tobacco. Never before has there been such a public health and safety concern over a plant, which at one time, was fairly benign, but now, with rising potencies is associated with violence, driving fatalities, increased youth access, use, and addiction, and negative impacts to the unborn. The United States must act accordingly and reign this in quickly before we lose generation of youth, destroy our environment, and to protect the public health and safety.", "comment_id": "ONDCP-2020-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0014", "comment_date": "2020-06-19T04:00:00Z", "comment_title": "06 19 20 Kenneth Finn", "commenter_fname": "Kenneth", "commenter_lname": "Finn", "comment_length": 693}, {"text": "I'm a 59 year old chronic pain patient with 4 autoimmune diseases. I've bad 20 surgeries in 17 years. There are no cures for the diseases I have. I've have tried multiple modalities to help ease my pain. I started with a pain management doctor 10 years ago. My pain had been kept to a tolerable level when I'm on pain medication. I have some quality of life now, but it's not as good as it could be since the CDC guidelines came out. My medicines were changed and dosages lowered. I try to stay active visiting a gym. I'm not expecting my pain medication to take away all my pain.I Just want to be able to do a few things. I've had to give up so many things because of the pain I suffer everyday. It's Not just me and my Doctor in the exam room anymore. Now the government is telling my doctor what he can and can't prescribe. I do not have an addictive personality or do my pain meds make me "high". I always pass my drug screenings and pill counts. I haven't done anything wrong but I'm being treated like a criminal. Please let doctors be doctors again and use the DEA to clean up our streets where the "illegal " heroin and fentanyl are killing people. My heart breaks for all the chronic pain patients who are suffering to the point of wanting just to die so the pain will stop. I chose to do this anonymously because I don't want anymore restrictions put on my medical history. I'm scared to death this has gone way too far with patients. ", "comment_id": "ONDCP-2020-0001-0018", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0018", "comment_date": "2020-06-19T04:00:00Z", "comment_title": "06 19 20 - Kerry", "commenter_fname": "Kerry", "commenter_lname": "Anonymous", "comment_length": 1519}, {"text": "See attached", "comment_id": "ONDCP-2020-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0011", "comment_date": "2020-06-05T04:00:00Z", "comment_title": "06 03 20 David G. Evans email", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "ONDCP's criteria that enables the country to be proactive in monitoring and identifying emerging drug threats to avoid public health crises has the potential to reverse destructive drug trends. The implementation of the sliding scale, both individually and holistically, allows for a more complete threat evaluation. There are three areas in which we can improve these criteria in order to prevent another crisis similar to the opioid epidemic. The first would be to prioritize or re-categorize these criteria to focus on the proactive measures, such as monitoring online discussions. Secondly, we must avoid the racial disparity experienced with the opioid crisis. Lastly, our outdated approach of smothering drug markets to force prohibition should be at the forefront when developing and implementing these criteria.
It would benefit all to prioritize or re-categorize these criteria based on preventive measures versus compiling data of newly diagnosed substance use disorders or measuring morbidity or mortality, when the damage has been done. Through identifying these avenues of discussion or activity early, we can increase interventions to keep the emerging drug threat at bay.
We also want to avoid racial divide over potentially criminalizing by prioritizing based on racial characteristics. "The narrative that today's heroin users are largely white and that heroin suppliers are largely black and Latino has contributed to the public's willingness to address opioid use less punitively" (Werle and Zedillo, 2018, p. 326). This has created massive disparities in our prison system. We must not prioritize criteria or use language that unfairly highlights a particular racial or ethnic group more than another.
Lastly, we must eliminate our reaction to smother drug markets, which actually makes the problem worse. Look at the Volstead Act during prohibition. Werle and Zedillo (2018) state that it "did far more to change what Americans drank than how much" (p. 330). Just as with the opioid crisis, eliminating access just pushes production, transportation, sale, and use underground. In addition, "overdoses are more common following cessation of naltrexone treatment than among either untreated heroin users or maintenance users" (Werle and Zedillo, 2018, p. 328). This may slightly benefit Big Pharma by allowing continuation of production and supply of a potentially dangerous drug; however, as a public-health focus, it is more dangerous if we try to eliminate the drug completely. We would benefit by removing or revising criteria that encouraged suppression that lead to illicit products, such as heroin, fentanyl, or synthetic opioids.
Some may object that this approach of rehabilitation versus criminalization by lowering access thresholds would "risk providing a[n] acceptable means for people to initiate drug use" (Werle and Zedillo, 2018, p. 338). However, this has not held true in countries, such as Switzerland, taking this public-health approach.
With these aspects in mind, we should re-categorize and reword the criteria, basing it on priority, equality, and a public-health approach instead of criminalized suppression. Through this proposed policy, we will see lives saved and decreased healthcare costs.", "comment_id": "ONDCP-2020-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0020", "comment_date": "2020-06-19T04:00:00Z", "comment_title": "06 19 20 Kerska", "commenter_fname": "Brian", "commenter_lname": "Kerska", "comment_length": 3344}, {"text": "See attached file(s)", "comment_id": "ONDCP-2020-0001-0013", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0013", "comment_date": "2020-06-19T04:00:00Z", "comment_title": "06 19 2020 Jesse LeBlanc", "commenter_fname": "Jesse", "commenter_lname": "LeBlanc", "comment_length": 20}, {"text": "The White House Drug policy has been completely off base for several years now. Due to relentless efforts by a Bloomberg influenced group of illegal lobbyists, PROP (Physicians for Responsible Opioid Prescribing), the Opioid Epidemic was adopted by the Trump Administration. This inadvertently helped profit a few severely corrupt and compromised individuals. The White House opioid policy was adopted upon corrupt and falsified CDC policy adopted in 2016. The US government went on full attack against prescribed opioids while overdose death continued to rise, unaffected, by the draconian opioid prescribing policies and laws being adopted at the federal and state level. These restrictions were promoted to the extreme detriment of pain patients numbering at least 50 million nationally. Fact: Studies show that prescription opioids comprise a very small percentage of all drug overdoses...usually under 5%. The real cause of deaths is counterfeit fentanyl in street drugs. That is why the White House attack on prescription opioids failed in a big way, because doctors do not prescribe counterfeit fentanyl -- drug dealers sell them.
The White House was misled by falsified policies that were adopted by the CDC due to illegal lobbying and other corrupt manipulations by Dr. Andrew Kolodny of PROP (Physicians for Responsible Opioid Prescribing). Kolodny who regularly steps aside from his Presidency position at PROP in order to appear uncompromised, was caught omitting information from his CDC disclosures. He is the founder of PROP, an agency that he claims is a non-profit. PROP is historically funded by rehab sources like Steve Rummler Hope Foundation and the Phoenix House. Kolodny launched the relentless attack on public opioid policy to benefit himself and his benefactors. PROP is the single force behind the promotion of the catastrophic CDC guidelines. His group was secretly inserted into the CDC guideline writing process in 2016, when Kolodny's former NY Health Dept. boss, Tom Frieden, appointed PROP members to misdirect public policy to accept the scientifically unfounded idea of 90 mme unit opioid limits. These limits were used to falsely suggest that prescription opioids were behind a rash of recent overdoses. The goal was to demonize opioid prescribers, manufacturers and patients into rehab treatment and to Suboxone. The Kolodny/PROP connections to past direct Suboxone marketing programs cannot be denied. Kolodny personally marketed Suboxone until 2005 for the city of New York under Mayor Bloomberg and now former CDC Director Frieden (then the NYC Health Director). He Marketed Suboxone by teaching Suboxone licensing classes until around 2017 (without disclosure.) Kolodny even promoted "Suboxone prescribed here" on the glass window of his personal psychiatric practice in New York. Kolodny holds two licenses for Suboxone prescribing and has given numerous interviews on the media suggesting that prescription opioids were to blame for the opioid epidemic and Suboxone is the cure. Kolodny even suggested in one article that he may have personally lost a great deal of money when Suboxone manufacturer, Reckitt Benckiser/Indivior was prosecuted by the DOJ for a variety of shady business practices including patent jumping. They were fined billions of dollars. But Kolodny didn't stop there. He promoted himself as an "opioid expert" and began testifying against opioid manufacturers in court for enormous fees of up to $750 per hour. He has continued to tamper with the CDC by recently submitting a letter comment urging the CDC not to correct the false opioid narrative that he, Frieden and PROP members promoted illegally via their participation in the leaked "Core Group" secretly assembled by Frieden to write the poorly conceived 2016 CDC Opioid Prescribing Guidelines. The guidelines were based on shoddy science with the 90 mme limit having absolutely no studies to back their usage whatsoever. 90 mme was based on category B, section 4 evidence...which is basically nothing more than conjecture. Kolodny's attempt to lobby the FDA on the 90 mme failed. The existence of counterfeit fentanyl as a primary threat to human life was ignored by the Core Group, but their tainted guidelines were pushed into effect with an illegally shortened public comment period.
Thousands of patients in pain have been harmed through the PROP corrupted CDC guidelines...losing jobs, homes, marriages and dignity. People who need surgeries are now avoiding these procedures due to the non-treatment of pain. People with hip surgeries are given Tylenol and ignored by desperate doctors. Hundreds have committed suicide -- desperate victims of untreated disease. Caring doctors are maliciously hounded by the DEA and mislead by false threats into giving up their DEA licenses to prescribe. Most have done nothing wrong and have no hope to appeal. The ONDC needs to research Kolodny and adjust for the corrupt CDC. I have attached a new PROP attempt to influence policy. ", "comment_id": "ONDCP-2020-0001-0017", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0017", "comment_date": "2020-06-19T04:00:00Z", "comment_title": "06 19 20 Robert Redfield", "commenter_fname": "Kirsten", "commenter_lname": "Klang", "comment_length": 5048}, {"text": null, "comment_id": "ONDCP-2020-0001-0024", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0024", "comment_date": "2020-06-29T00:00:00Z", "comment_title": "06 29 20 Todd Gillum (1)", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "ONDCP-2020-0001-0021", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0021", "comment_date": "2020-06-19T00:00:00Z", "comment_title": "06 20 20 Luna-Ly_Federal-Public-Comment - email", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": "This comment addresses the Office of National Drug Control Policy (ONDCP) specifically 21 CFR Part 1401 (RIN 3201-AA02) entitled Criteria for Designation of Emerging Drug Threats in the United States. To determine the emerging drug threats a committee was created and established 11 proposed criteria to identify emerging drug threats and I would like to propose an additional criteria to specifically address the vulnerable population of children aged 12-18, for whom drug abuse can be particularly debilitating, by examining federal, state, local and tribal data for the emergence of use of new or evolving drug, class of drugs, or other substances in this population. This new proposed criterion should exclude substance abuse disorder because waiting for children to develop a substance abuse disorder as written in criteria 7 will prove to be too late.
This additional criterion is important because drug misuse has been shown to increase with age starting in early adolescence and peaking in early adulthood (McGorry et al., 2011). With this fact in mind, interventions that aim to stop or postpone the onset of drug use should be targeted to a specific population before or during adolescence (McGorry et al., 2011). In order to effectively decrease the burden of emerging drug trends and its effect on medical and public health, the ONDCP must be able to carefully consider the adolescence population and quickly determine patterns to avoid another opioid crisis. Many are aware of the health hazard that adult opioid abuse poses in the United States, however the effect of opioid abuse on children is often overlooked. Opioid abuse is a major public health issue for children in the United States and is clearly evident with the increasing number of emergency department visits by young children and adolescents for poisoning by prescription opioids (Allareddy & Rampa, 2017). Emerging drugs threats in adolescence must be identified and action must be taken early to prevent future public health hazards.
References:
Allareddy, V., & Rampa, S. (2017). Opioid abuse in children: an emerging public health crisis in the United States. Pediatric Research, 82(4), 562-563.
McGorry, P., Purcell, R., Goldstone, S., Amminger, G. (2011). Age of onset and timing of treatment for mental and substance use disorders: Implications for preventive intervention strategies and models of care. Current Opinion in Psychiatry, 24(4), 301-306.
", "comment_id": "ONDCP-2020-0001-0033", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0033", "comment_date": "2020-06-30T04:00:00Z", "comment_title": "06 30 20 Leiber", "commenter_fname": "Nicole", "commenter_lname": "Lieber", "comment_length": 2478}, {"text": "See Attached", "comment_id": "ONDCP-2020-0001-0032", "comment_url": "https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0032", "comment_date": "2020-06-30T04:00:00Z", "comment_title": "06 30 20 Goodwin", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}]}, {"id": "FDA-2011-P-0045", "title": "Refuse to Approve King's Remoxy NDA Unless the Conditions Specified In the Petition Are Satisfied- CLOSED", "context": "2013-05-30T07:18:25Z", "comments": []}, {"id": "FDA-2017-P-5370", "title": "Requests that the FDA place a black box warning on pharmaceuticals in the CII opioids warning that the use of this kind of opioid carries greater risk of addiction and overdose death than the use of CIII opioid.", "context": "2019-03-28T11:04:16Z", "comments": []}, {"id": "FDA-2017-N-1094", "title": "Training for Opioid Analgesic Prescribers--Exploring the Path Forward", "context": "2017-08-25T16:17:17Z", "comments": [{"text": "Please see the attached file with personal testimony from a mother about her son which addresses the real needs of a chronic pain patient who suffers verifiable, substantiated, persistent chronic pain due to a genetic condition that results in daily subluxations and dislocations of joints. It discusses the necessary use of opioid medications in a controlled environment with doctor supervision, and how important reasonable access to opioids is in the treatment of his particular medical problem.", "comment_id": "FDA-2017-N-1094-0160", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0160", "comment_date": "2017-06-23T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 499}, {"text": "Dear Dr. Throckmorton,
Let's go back in time for a minute and recognize that FDA's ineffective warning, regarding the dangers of corticosteroids used to treat back pain, continues to result in unsustainable numbers of catastrophic injuries throughout the country - and the legitimate need for opioids for adhesive arachnoiditis patients (including misdiagnosed cases of Fibromyalgia).
As we both know, the topic of pain is complex (and not what it appears) as underlying profit motives have skewed accurate statistics.
On the National debate:
Federal OWCP is willing to authorize reimbursement for repeated, high risk epidural steroid injections. Ron Angel was offered ESI treatment indefinitely for his low back pain (approx. $2000 per injection). Ron also suffered an OTJ cervical spine injury, now a retired wildland fire fighter:
https://www.painnewsnetwork.org/stories/2015/10/21/jumping-from-fire-into-federal-work-comp-nightmare
For the record (again), the most commonly used corticosteroid used for back pain is Pfizer's Depo-medrol. Below is the link to Pfizer/New Zealand Depo-medrol datasheet:
http://www.medsafe.govt.nz/Profs/Datasheet/d/Depomedrolinj.pdf
Please note top of page 7: "Depo-Medrol may be used by any of the following routes: intramuscular, intra-articular, periarticular, intrabursal, intralesional and into the tendon sheath. It MUST NOT be used by the intrathecal, epidural or intravenous routes (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE EFFECTS)."
And bottom of page 18: "ADVERSE EFFECTS
Administration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, headache, functional gastrointestinal disorder/bladder dysfunction, seizures, visual impairment including blindness, ocular and periocular inflammation, and residue or slough at injection site."
FDA's warning has not changed the harmful standard of care for back pain, or the problem of injured worker coercion to undergo high risk, high cost injections: https://www.fda.gov/Drugs/DrugSafety/ucm394280.htm
We have reason to believe that FDA sold out to the interests of professional medical societies and large corporations (Pfizer). Arachnoiditis is grossly misdiagnosed for fear of legal liability; adverse events are under-reported/not reported to FDA for same reason.
Check out the comment written by Dr. Laxmaiah Manchikanti, Chairman of the American Society of Interventional Pain Physicians in Pain News Network blog:
https://www.painnewsnetwork.org/stories/2015/8/19/experts-say-epidural-injections-overused
Laxmaiah Manchikanti, MD 2 years ago Pending Awaiting Moderation 1 like
This is a very interesting perspective; however, there appears to be significant misinformation. All in all arachnoiditis is a significant problem which has been missed by multiple governmental agencies as well as physician organizations. It will not go away by ignoring it. All parties have responsibility. It can be avoided by utilizing alternate techniques, alternate drugs, and finally patients must also share responsibility. In the United States, no one can force anyone to have a procedure. Further, each and every patient should be educated about and understand the risks and benefits of any and all procedures and physicians should explain to them that steroids are an off-label use.
When you add up the error rates and multiply the estimated numbers of ESIs administered annually, you start to realize the magnitude of the problem. This cumulative trauma impacting the American public is not sustainable -- and little is being done to address medical malpractice taking place across the country. Both FDA and CDC are disregarding this public health crisis.
Let's face it: these agencies are run by politically appointed administrators. Dr. Tennant should be leading discussions on long term intractable pain conditions at FDA. Instead, the view is lop-sided, thanks to the likes of PROP, Ballantyne, and Sullivan:
https://www.painnewsnetwork.org/stories/2015/12/10/controversy-grows-over-journal-article-on-pain-treatment
On the Montana Front - please familiarize yourself with these egregious cases:
https://www.painnewsnetwork.org/stories/2017/5/26/patient-suicide-blamed-on-montana-pain-clinic
https://www.painnewsnetwork.org/stories/2017/5/18/patients-allege-mistreatment-at-montana-pain-clinic
https://www.painnewsnetwork.org/stories/2017/5/19/montana-urine-tests-sent-to-bankrupt-drug-lab
http://mtpr.org/post/pain-helped-him-pull-trigger
Unsuspecting back pain patients are pushed into harmful procedures then end up with permanent injuries and chronic pain for the remainder of their lives. Corporate decision makers deny these injuries and abandon them in their time of need.
We've been here done this.
Submitted on behalf of Arachnoiditis Awareness and Prevention A.S.A.P.
", "comment_id": "FDA-2017-N-1094-0251", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0251", "comment_date": "2017-07-12T04:00:00Z", "comment_title": "Comment from Terri Anderson", "commenter_fname": null, "commenter_lname": null, "comment_length": 5323}, {"text": "I've had moderate-to-severe rheumatoid arthritis for 9 years now. It is a very painful condition that is quite a challenge! I had to go on Disability, because I cannot depend on my body's ability to do just normal day-to-day activities consistently.
I started taking Percocet, which is an opioid, with my first flare-up in 2008. Flare-ups affect multiple joints all over my body with burning, throbbing, aching, stiff & swelling joints that usually last between 3-6 months. When the disease finally calms down to moderate status, my joints have a dull ache that causes extreme fatigue, so I still need pain relievers when I do projects that require more strength in my joints or when the pain is too uncomfortable to sleep. Unfortunately, with this disease, there has never been a day without pain. I have continued taking opiates for almost a decade, because getting some relief is worth the risk. Since there are some days when I can go without pain relievers, I have never considered myself to be an addict. I take my opiate medications responsibly. I have used many alternative ways to help relieve the pain, everything from acupuncture to tapping. I am not addicted, but I am dependent on opiates, as another tool to make my life productive, worth living, & less painful.
A few years ago, many obstacles were set in place to make it extremely difficult to obtain prescriptions for pain relief. The federal government, in deciding to stop people from becoming addicted to opioids, made it extremely difficult for people like me, with a chronic pain condition, to continue getting the very medications that make our lives tolerable & worth living. The CDC, DEA, FDA, NIH, & members of local & federal government have made our lives painful and unproductive. Our Quality of Life is being taken away from us! It is influencing our physicians, because now they are refusing to continue to prescribe opiates to control long-term chronic pain. They fear for their careers instead of caring for their patients.
My prescriptions have been reduced to half the dosage needed to lessen the pain, and this has totally altered the way I live my life, significantly reducing my capabilities. Extreme limitations & inconvenience along with increased office visits & costs are just a few of the many roadblocks we face in getting our prescriptions for pain relief now.
It's not fair to punish those of us who legitimately need opiates due to a disease or injury, in an effort to curtail another group that chooses to abuse the medications we need to live our lives in a productive way. Our lives literally depend on these medications to function. My disease has become much worse as a result of not being able to access the opioid medications that are necessary to lessen my pain, allow me to function, and be productive; whether it is to enable me to still work for a living or just be able to do things as simple as opening a door, cooking, doing housework, or just getting ready for the day.
In my experience, Pain Management Specialists are not needed. Mine does not understand my disease at all, & I am treated like an addict. He is a spine specialist which has nothing to do with rheumatology. Per his suggestions, I have tried various pain relievers, even one that caused me tremendous harm. He doesn't understand my pain or the cause, but I now have to pay for 2 doctor visits, 1 for the disease & 1 for pain. It is very expensive, stressful, & time-consuming just to be able to lessen the pain associated with my disease now. Healthcare was better & more efficient when my rheumatologist was able to treat both the disease & the pain.
CDC Guidelines were created in a sneaky, underhanded way without any expertise. (Attached)
The DEA has scared physicians out of treating pain. The FDA has required pharmaceuticals to reformulate opioids, which is a complete fail. The reason I know this is because when a Pain Management Specialist prescribed Oxycontin ER, my first month was the old formulation which lessened the pain adequately. However, the next month I received a new formulation which did not work at all for me.
Most people do not understand that the "opioid problem" is a substance abuse problem, not a chronic pain problem. As Dr. Kolodny & CDC continue to propagandize the false narrative that our medications are the problem and lump them in the same category as heroin, cocaine, & illegal fentanyl, we cannot live our lives productively & suicides will continue to happen more often. (Attached)
My suggestions are:
1.Immediate withdrawal of CDC guidelines for rewriting by a much better qualified stakeholder group including both pain management specialists & chronic pain patients.
2.DEA should be forced by Congress to cease prosecution of doctors whose only "crime" is an attempt to serve the medical needs of their patients.
3.Specialists like Rheumatologists should prescribe pain medications, because they understand both the disease & the pain associated with it.", "comment_id": "FDA-2017-N-1094-0112", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0112", "comment_date": "2017-05-22T04:00:00Z", "comment_title": "Comment from Pam Hawthorne", "commenter_fname": null, "commenter_lname": null, "comment_length": 5262}, {"text": "Attached please find comments submitted by the National Community Pharmacists Association (NCPA). ", "comment_id": "FDA-2017-N-1094-0272", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0272", "comment_date": "2017-07-12T04:00:00Z", "comment_title": "Comment from National Community Pharmacists Association", "commenter_fname": null, "commenter_lname": null, "comment_length": 98}, {"text": "Please start over with appropriate CDC guidelines.
Doctors need reassurance that it is safe to help chronic pain patients,
Preventing suicides in opiate refugees.
We must help patients who have become dependent on opiates over the last two decades.
Some cannot wean off opiates.
In my home state of Montana, there is a hostile regulatory environment for doctors who help pain patients. ", "comment_id": "FDA-2017-N-1094-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0018", "comment_date": "2017-05-05T04:00:00Z", "comment_title": "Comment from Mark Ibsen", "commenter_fname": null, "commenter_lname": null, "comment_length": 411}, {"text": "This is crony capitalism! Why are we attacking law abiding citizens using narcotic pain killers with government intervention? If the pain patients don't get their treatment from a doctor they will get it from a dealer. Heroin use will go up if we restrict pain medication for patients. Great for big government jobs for all the law enforcement involved in the war on drugs but terrible for the patient. This is just like gun control where overzealous idiots try to take guns from law abiding citizens to reduce gun ownership by criminals and it NEVER WORKS! Get big government out of the doctors office; these people went to school for YEARS and they know better than government agencies what their patients need. If you support restrictions on patients pain medications I hope you die a slow and painful death yourself so that you become a victim of your own legislature. Doctors and patients don't need the government counting their pills.", "comment_id": "FDA-2017-N-1094-0050", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0050", "comment_date": "2017-05-12T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 957}, {"text": "See attached file(s)", "comment_id": "FDA-2017-N-1094-0137", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0137", "comment_date": "2017-05-30T04:00:00Z", "comment_title": "Comment from Effie Tetteh", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Hi again. The past few months I have been slowly buying things to make artisan soaps. I have been on SSI for years with my autistic daughter. I want to DO THINGS! BE PRODUCTIVE and give back! If I have to sit in a chair and cry all the time, how could I possibly live? No human wants to do nothing and be in constant pain. This kind of pain never goes away. No, I would never kill anyone, but this kind of pain is relentless.
Broderick's neighbors told the Review Journal that he was a husband and father of two, who mostly kept to himself but had a friendly wave. One neighbor called Broderick a "really nice gentleman" who complained of back pain.
"He used to talk about taking pain pills," said Welborn Williams. "He couldn't get any sleep at night."
Broderick's Facebook page reveals a man who loved fishing and was a gun enthusiast. Ironically, in 2012 Broderick recommended without comment on his page a story about an employee at a Las Vegas medical clinic who was shot during an armed robbery.
The Review Journal reported that Broderick had a concealed weapons permit and five firearms. Williams said Broderick had offered to teach him about firearms.
"I hate to see anyone in pain like that," Williams said. "But there should have been another way for him."
https://www.painnewsnetwork.org/stories/2017/6/30/patient-shoots-two-at-las-vegas-pain-clinic
http://www.pharmaciststeve.com/
An email received this week from a chronic pain activist: "We just lost another intractable member of our support group two nights ago. She committed suicide because her medications were taken away for interstitial cystitis (a horribly painful bladder condition) and pudendal neuralgia, both of which she had battled for years. The nerve pain is equivalent to end-stage cancer pain, but the CDC and doctors in Colorado were merciless. She just couldn't hang on any longer without hope." She was just 30 years old.
http://globalnews.ca/news/3571142/commentary-a-deeply-disturbing-email-begins-to-tell-the-opioid-story-for-chronic-pain-patients/
"There's a difference between the people (who) need them and the people who are abusing them," Kain said.
The CDCin 2016 released new guidelines that discourage primary care doctors from prescribing opioids for chronic pain. The guidelines were meant to curb the rampant over-prescribing practices of the past but may have also created unintended consequences. "I don't walk with a cane. I don't have an open wound. I'm not in a wheelchair," Kain said, adding that looks can be deceiving. Most of the time, she's stuck in her Pleasant Hill home trying to get through the day with excruciating back pain.
http://www.kcci.com/article/has-opioid-epidemic-vilified-chronic-pain-patients/9970531", "comment_id": "FDA-2017-N-1094-0183", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0183", "comment_date": "2017-07-07T04:00:00Z", "comment_title": "Comment from Bambi Tuckey", "commenter_fname": null, "commenter_lname": null, "comment_length": 2910}, {"text": "I am a chronic pain patient and it took over 8 months to officially diagnosis me. I agree with training those prescribing pain medication both on pain and addiction signs. I also agree with go slow and low but not making it LAW because think about my situation I have Complex Regional Pain Syndrome CRPS and if you make limits on pain medication a law by state I have to go every week to the doctor to get a new prescription, pay co pays every week, go to the pharmacy every week until officially diagnosed with chronic pain. This puts burdens on the doctors time and the patients time and money. Most chronic pain patients take medication responsibly to ease the pain. We aren't taking it to "feel good". There must be some subjectivity when dealing with pain. The 30 day to now 3-7 days has been rectified, urine screens happen monthly, we go every month to the doctor as implemented. The focus needs to be on illicit drugs on the street. Evidence has proved that prescriptions have declined while overdoses have increased. Some insurances don't cover investigational treatments so your options are limited by insurance. You can't put real pain patients into one box and you can't scare doctors so much they abandon patients because of too much oversight. They are trained and if they aren't get them to take an online course and if a patient needs to be in pain management get them to a specialist. We must find a way to stop hurting real pain patients because we deserve care just like someone with cancer does and we also need to find a place for those suffering side effects of taking pain medication and get them help. Stop hurting and start helping. I'd love for CDC and politicians making black and white rules to live just one day in my shoes. Talk to the different chronic pain support groups, rare disease groups. You must hear both sides and bring the pendulum back that has swung way to far in err of hurting pain patients. ", "comment_id": "FDA-2017-N-1094-0086", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0086", "comment_date": "2017-05-18T04:00:00Z", "comment_title": "Comment from Amy V", "commenter_fname": null, "commenter_lname": null, "comment_length": 1987}, {"text": "Note I have RA, OA, fibromyalgia, degenerative & herniated disk (lumbar & cevical). Been on opioid 20 yrs this yr. I want to increase my meds from 4 to 5 a day. Instead I was given a stronger med 4 's
a day. Stronger is not as effective as the one I was taking. I've protested but Dr's say can't prescribe more than 4 a day, so I suffer in silence. Afraid to upset the apple cart.", "comment_id": "FDA-2017-N-1094-0095", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0095", "comment_date": "2017-05-18T04:00:00Z", "comment_title": "Comment from Michelle Harford", "commenter_fname": null, "commenter_lname": null, "comment_length": 408}]}, {"id": "FDA-2006-P-0329", "title": "Request All Applicants for Fentanyl Transdermal Systems Conduct A Study to Support the Safety of Their Fentanyl Transdermal Products-CLOSED", "context": "2021-09-01T01:01:35Z", "comments": []}, {"id": "FDA-2022-N-2673", "title": "Safety and effectiveness of certain naloxone hydrochloride drug products for nonprescription use; Request for Comments", "context": "2023-01-20T13:40:36Z", "comments": [{"text": "As a licensed HCP I support that all naloxone products should be moved from prescription to OCT status. The FDA choosing not to evaluate all products (even the 8 mg intranasal product KLOXDXADO and the 5 mg ZIMHI) to OTC is beyond perplexing.
Move naloxone to OTC NOW! ", "comment_id": "FDA-2022-N-2673-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0003", "comment_date": "2022-11-17T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 279}, {"text": "Komen", "comment_id": "FDA-2022-N-2673-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0002", "comment_date": "2022-11-17T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5}, {"text": "I am writing to submit my support for nonprescription/over-the-counter access to naloxone formulations across the United States. I am a PhD health researcher whose dissertation focus was on opioid use disorder and harm reduction. Naloxone saves lives, it is as simple as that. Increasing access to naloxone can help reduce overdoses and overdose deaths. Naloxone cannot be used recreationally, and there has been no scientific evidence of significant harm related to naloxone administration that outweighs the risks of opioid overdose. ", "comment_id": "FDA-2022-N-2673-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0004", "comment_date": "2022-11-17T05:00:00Z", "comment_title": "Comment from Maria Bolshakova", "commenter_fname": null, "commenter_lname": null, "comment_length": 536}, {"text": "ZIMHI is an amazing product! ", "comment_id": "FDA-2022-N-2673-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0071", "comment_date": "2022-12-22T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 29}, {"text": "Please allow naloxone to be distributed over the counter! In fact, if there is a way to have it available OTC for free - that would be the best harm reduction our country could provide to our citizens. It is a public health mechanism to save lives. My clinical practice is treating substance use disorders and I get out all the narcan I have. It is the best way to reverse an overdose and it needs to be readily available to everyone.", "comment_id": "FDA-2022-N-2673-0066", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0066", "comment_date": "2022-12-20T05:00:00Z", "comment_title": "Comment from Kathy Nevins", "commenter_fname": null, "commenter_lname": null, "comment_length": 434}, {"text": "See attached file(s)", "comment_id": "FDA-2022-N-2673-0070", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0070", "comment_date": "2022-12-22T05:00:00Z", "comment_title": "Comment from American Society of Anesthesiologists", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "We have decades of experience showing that laypeople with minimal training can successfully use naloxone to save lives. FDA desperately needs to make naloxone available over-the-counter in order to eliminate the myriad bureaucratic barriers that stem from its current status as a prescription-only product. While recent efforts, like the clarification related to the DSCSA, have gone a long way toward making naloxone easier to procure by harm reduction programs, they do not get rid of all hurdles. Additionally, making naloxone OTC would help protect end users who are sometimes harassed by police for having a prescription-only medicine. While I welcome FDA’s initiative to encourage sponsors to apply for OTC status for certain formulations and dose strengths, FDA’s preliminary assessment unfortunately leaves out the products with the longest track record of community use – 0.4 mg/mL intramuscular naloxone. The evidence of success of community naloxone programs is largely built upon the long use of IM product by lay bystanders. These decades of experience show that it is appropriate and safe for community use – especially by people who use drugs who are most often the frontline responders. This product is truly the backbone of the harm reduction naloxone response. And importantly, it is much more affordable than intranasal and autoinjector products. FDA should go further than simply encouraging companies to apply for OTC status for certain IN and autoinjector products. The agency should itself initiate an OTC switch for the widely used IM formulation. Not doing so risks giving the appearance that this critically important formulation is a second-tier product, which will have real implications for the harm reduction programs that rely on it, and for the people who use it.", "comment_id": "FDA-2022-N-2673-0067", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0067", "comment_date": "2022-12-20T05:00:00Z", "comment_title": "Comment from Roxanne Saucier", "commenter_fname": null, "commenter_lname": null, "comment_length": 1819}, {"text": "As a public health nurse, I strongly support the availability of over-the-counter naloxone. Naloxone is a life-saving medication that is safe and effective for the reversal of opioid overdose. In fact, naloxone is far safer than many currently available over-the-counter products. Many states allow widespread dispensing of naloxone, which has been shown to be a public health benefit.
With increased access, the public would also benefit from widespread education campaigns that explain the signs of opioid overdose, how to respond, and how to access effective treatments for opioid use disorder (of which the gold standard is opioid agonist medications).
OTC naloxone may have the added benefit of normalizing carrying naloxone and destigmatizing the use of opioids. While much more is needed to destigmatize drug use and addiction, OTC naloxone would be a small step in this direction.
", "comment_id": "FDA-2022-N-2673-0075", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0075", "comment_date": "2022-12-29T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 907}, {"text": "With the increase of synthetic fentanyl and opioid-related deaths across the country, expanding access and eliminating barriers to Narcan is pertinent. I work in patient access in the pharmaceutical industry for an unaffiliated company. I have no ties to this legislation or companies involved other then I’m the daughter of a recovering addict. I found my dad cold and blue, from an opioid-overdose. I called 911 and when the paramedics used 4 cans of Naloxone to save his life that night. The paramedics said if they would’ve arrived 15 seconds later, he would’ve died. My dad has overdosed multiple times but this was the closest call and it was directly in front of me. Had I had access to Narcan OTC, I would’ve administered it myself waiting for the paramedics to arrive. A friend lost her boyfriend to an accidental overdose due to synthetic fentanyl being laced. She to found him cold and blue, administered CPR, the paramedics used multiple cans of Narcan and could not revive him. It was simply too late and the fentanyl was too strong. Another family member overdosed on thanksgiving, his friend had a prescription for Narcan, and administered narcan and saved him on the driveway. I then submitted documents to get him baker acted and on the road to recovery. Addicts do recover, they just need the opportunity to do so and having Naloxone OTC without a prescription provides that opportunity. The proposed switch will expand consumer access and save lives. Personally, I would always keep Narcan in my purse in case anyone needs me to administer it. Increased access to Naloxone is vital to the public. ", "comment_id": "FDA-2022-N-2673-0077", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0077", "comment_date": "2023-01-04T05:00:00Z", "comment_title": "Comment from Savannah Simbulan", "commenter_fname": null, "commenter_lname": null, "comment_length": 1641}, {"text": "I support over-the-counter availability of naloxone due to the overwhelming likelihood that the people responding to an overdose will not have had the ability to obtain a prescription. A lifesaving, time-sensitive drug should not be gated behind a doctor’s prescription, particularly when the people most likely to use it will be recalcitrant to openly admit they are users of illegal drugs. ", "comment_id": "FDA-2022-N-2673-0100", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0100", "comment_date": "2023-01-13T05:00:00Z", "comment_title": "Comment from Sam Gross", "commenter_fname": null, "commenter_lname": null, "comment_length": 398}]}, {"id": "FDA-2001-P-0191", "title": "Refrain Approval of Any Buprenorphine Product-CLOSED", "context": "2021-09-01T02:02:08Z", "comments": []}, {"id": "FDA-1977-N-0411", "title": "Relationship of Methadone Treatment Programs", "context": "2021-09-01T18:06:33Z", "comments": [{"text": "N/a", "comment_id": "FDA-1977-N-0411-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1977-N-0411-0002", "comment_date": "2012-08-07T04:00:00Z", "comment_title": "The ADDICTION CTR", "commenter_fname": null, "commenter_lname": null, "comment_length": 3}, {"text": "N/a", "comment_id": "FDA-1977-N-0411-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1977-N-0411-0003", "comment_date": "2012-08-07T04:00:00Z", "comment_title": "EXEC OFFICE OF PRESIDENT", "commenter_fname": null, "commenter_lname": null, "comment_length": 3}]}, {"id": "FDA-1999-P-3513", "title": "ANDA Suitability Proposed a Dosage of Oxycodone and Acetaminophen Oral Solution-CLOSED", "context": "2021-09-01T02:04:14Z", "comments": []}, {"id": "FDA-2023-N-3159", "title": "Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants \u2013 Oxycodone", "context": "2023-08-23T13:46:06Z", "comments": []}, {"id": "FDA-2000-P-0024", "title": "ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen-CLOSED", "context": "2021-09-01T02:00:35Z", "comments": []}, {"id": "DEA-2017-0013", "title": "Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl into Schedule I", "context": "2021-12-02T01:00:51Z", "comments": []}, {"id": "FDA-1995-P-0004", "title": "ANDA Suitability for 2.5mg Hydrocodone Bitrate & 5mg Phenylephrine-CLOSED", "context": "2021-09-01T18:02:49Z", "comments": []}, {"id": "DEA-2007-0060", "title": "Control of a Chemical Precursor Used in the Illicit Manufacture of Fentanyl as a List I Chemical", "context": "2011-06-11T09:53:54Z", "comments": []}, {"id": "FDA-2013-P-0675", "title": "Declare That Tramadol Hydrochloride 37.5 mg and Acetaminophen 300 mg Tablets, is Suitable for Submission as an ANDA- withdrawn 11/17/22", "context": "2022-11-18T11:24:24Z", "comments": []}, {"id": "FDA-1976-N-0517", "title": "Methadone", "context": "2021-09-01T18:02:34Z", "comments": []}, {"id": "FDA-2005-P-0054", "title": "re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the controlled substances Act of 1970,as amended", "context": "2021-09-01T01:01:13Z", "comments": []}, {"id": "DOT-OST-2016-0189", "title": "Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Synthetic Opiates and Minor Amendments", "context": "2018-01-10T08:47:39Z", "comments": [{"text": "See attached file(s)", "comment_id": "DOT-OST-2016-0189-0048", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0048", "comment_date": "2017-03-23T04:00:00Z", "comment_title": "Comment from Robert E. Willette", "commenter_fname": "Robert", "commenter_lname": "Willette, Ph.D.", "comment_length": 20}, {"text": "Comments from the Association of Flight Attendants-CWA, AFL-CIO", "comment_id": "DOT-OST-2016-0189-0037", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0037", "comment_date": "2017-03-17T04:00:00Z", "comment_title": "Comment from Association of Flight Attendants-CWA, AFL-CIO", "commenter_fname": "Heather", "commenter_lname": "Healy", "comment_length": 63}, {"text": " I Dajuan Leavell a previous employee under the federal Department Of Transportation in Toledo, Ohio will love to comment
on the 49 rule of shy bladder. I think that the MRO evaluation process under the shy bladder situation is not reasonable at all.
I understand that an individual could hold his or her urine in for 3 hours due to them knowing the results will be positive. Altho
ugh what about the ones that are negative without a medical history and documentations of urinating problems? They do not get to prove there
innocents and they could also loose there livelihood. This is very unfair! its almost like robbery of your career to a existing
medical condition that was currently discovered. There has got to be a better way to prove your innocents in this situation.
Its hard to believe the MRO will consider a highly probable condition without medical documentation. I even offered blood and a hair test. YOU LOOSE GOOD
RELIABLE EMPLOYEES this way. I had never failed a drug test in my life. It hurts so bad its like being convicted of a crime
you didn't do. I committed 5 years to my employer no call offs and worked when the needed me, no discipline nothing on
my file or record. And this shy bladder situation is a joke when you don't look further into the situation. It could be something
that an employee will find out when its too late and lost there job!! You guys have to do better than that!!
Thank You for taking the time out to here me out. Please feel free to give feedback. My email is dajuanleavell23@gmail.com
", "comment_id": "DOT-OST-2016-0189-0009", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0009", "comment_date": "2017-01-30T05:00:00Z", "comment_title": "Comment from Dajuan Leavell", "commenter_fname": "Dajuan", "commenter_lname": "Leavell", "comment_length": 1598}, {"text": "
March 24, 2017
VIA Federal eRulemaking Portal
Docket Management Facility
U.S. Department of Transportation
1200 New Jersey Ave., SE
West Building Ground Floor Room W12-140
Washington, DC 20590-0001
Subject: Docket No. DOT-OST-2016-0189
Dear Docket Clerk,
The San Francisco Municipal Transportation Agency (SFMTA) appreciates the opportunity to review the U.S. Department of Transportation's (DOT) proposal to revise its drug testing program regulations as follows:
Align DOT's regulated-industry drug testing with the Department of Health and Human Services (HHS) laboratory drug testing requirements;
Add clarification to certain existing drug-testing provisions;
Remove outdated information from DOT's current regulation; and,
Remove the requirement for employers and C/TPAs to submit blind specimens.
We are in agreement and support the proposed changes.
SFMTA would also like to take this opportunity to express its interest in commenting on other aspects of the DOT regulations that are not currently open as part of this proposed rulemaking, such as post-accident testing, definition of an accident, and when drug testing is deemed appropriate. For example, we believe that the current definition of "accident" may not be broad enough to encompass other situations for which testing may be appropriate, such as serious safety violations, e.g., signal violations.
Specifically, we would welcome an opportunity to comment formally on the following sections of the Code of Federal Regulations (CFR): 49 CFR 655.4: Definitions, "Accident"; 49 CFR 655.43: Reasonable Suspicion Testing; and, 49 CFR 655.44: Post-Accident Testing.
We strongly encourage DOT to initiate a formal discussion on these issues as soon as possible. If you have any questions or require additional information, please do not hesitate to contact me at 415.701.4720 or Ed.Reiskin@sfmta.com.
Sincerely,
Edward D. Reiskin
Director of Transportation
", "comment_id": "DOT-OST-2016-0189-0070", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0070", "comment_date": "2017-03-27T04:00:00Z", "comment_title": "Comment from San Francisco Municipal Transportation Agency", "commenter_fname": "Edward", "commenter_lname": "Reiskin", "comment_length": 2318}, {"text": "See attached file(s)", "comment_id": "DOT-OST-2016-0189-0060", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0060", "comment_date": "2017-03-24T04:00:00Z", "comment_title": "Comment from CONSOL Energy Inc.", "commenter_fname": "Steven", "commenter_lname": "Buffone", "comment_length": 20}, {"text": "See attached PDF", "comment_id": "DOT-OST-2016-0189-0063", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0063", "comment_date": "2017-03-24T04:00:00Z", "comment_title": "Comment from Transportation Trades Department, AFL-CIO", "commenter_fname": "Edward", "commenter_lname": "Wytkind", "comment_length": 16}, {"text": "Comment provided by: Lisa Bradley; Certified Training Solutions
RE: DOT-OST-2016-0189-0038
We would like to express a similar opinion regarding 40.33, commented by SAPAA.
The concern is the requirement for all collectors, BATs, STTs, SAPs, and MROs to subscribe to the free ODAPC list-serve. This is an excellent idea, and we stress to our trainees that they need to sign up for updates online and that it is their responsibility to keep up with Regulation changes. However, please consider allowing more time (beyond the October 1, 2017 effective date) for all of these service agents to subscribe to the email updates list. We intend to communicate to our clients that they must subscribe to the list; however, we believe there will be many service agents that may not be aware of the requirement in such a short time (and thereby, be out of compliance once the Rule takes effect). We believe that allowing a bit more time for more service agents to hear about the Rule will result in a higher compliance rate once it goes into effect.
Some of our clients in covered industries have also expressed concern, since they are responsible for ensuring they use only compliant service agents. A question to consider is: Who is responsible for ensuring that all of these BATs, Collectors, etc. actually are on the email updates list and how will it be enforced?
Example: A trucking company uses a collection site/clinic for their urine drug collections, and the DER initially checks to ensure that all currently-employed collectors and BATs are subscribed to ODAPC's list-serve. However, there is often a lot of turnover in these types of positions at clinics and collection facilities. If every DER at every covered-company has to call every service agent (and document) frequently -possibly even daily to truly ensure full compliance - this will create significant new costs and record-keeping burdens on covered employers that may not have been considered in the new language.
Thank you for the opportunity to comment.", "comment_id": "DOT-OST-2016-0189-0054", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0054", "comment_date": "2017-03-23T04:00:00Z", "comment_title": "Comment from Lisa Bradley", "commenter_fname": "LISA", "commenter_lname": "BRADLEY", "comment_length": 2085}, {"text": "I believe that all drivers, in any instance, need to be tested for any kind of drug in their system because it is very unsafe to drive, specially, commercial vehicles under the influence of drugs because these drugs do not let people react as the normally would.", "comment_id": "DOT-OST-2016-0189-0032", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0032", "comment_date": "2017-03-09T05:00:00Z", "comment_title": "Comment from Miguel Lopez", "commenter_fname": "Miguel", "commenter_lname": "Lopez", "comment_length": 262}, {"text": "Dear Regulators,
I've worked over 20 years in this industry as a marketing rep for a SAMHSA certified lab, a collector-trainer and for a TPA. In my job, I communicate with labs, collection sites, TPA's, BAT techs and employers on the DOT regulations and collection requirements. I agree in the addition of the synthetic opioids and believe this would greatly increase safety for the public and help provide intervention to those who suffer with drug addiction. I also agree with the minor changes mentioned. I do feel the collector training should include the following scenarios for mock collections as a minimum: 1. Standard mock collection (no errors) 2. Shy bladder A. The normal scenario where the donor eventually provides a full specimen within range B. The unusual scenario where the donor stays all 3 hours, is compliant, but does not provide a specimen. 3. A specimen offered where the specimen is either "temp out of range" or "appears to be tampered" and the donor agrees to the 2nd observed collection. #4 would be the 2nd observed collection, also talking about the other scenarios when an observed collection may be ordered and 5. A refusal to test (being disruptive, not follow collection instruction, etc.) and 5B: Items a donor can refuse to do (i.e. not initial bottles seals or sign the COC form or provide a full SS #, that does not cancel the test when the donor follows all other guidelines. I find when you cover all of these items with mock collections, there are less errors and better retention. I also have found some SAMHSA certified labs have found the ability to test beyond the limited description for substitute specimens in order to capture the use of synthetic urine, (which is a real problem, and needs to be addressed). I believe the actual DOT positive drug test rate is far higher than reported. Labs should be able to use proprietary methods without having to fully disclose what they are except to the MRO who views the test result and the SAMSHA certified labs who would do a secondary confirmation test to verify the same result. It's a little like computer viruses and hackers, labs are always trying to stay one step ahead of the bad guys who would tamper with a test, but under the current DOT regulations, they have to give out the formula on how to do it. This really is a 2nd subject that deserves it's own rulemaking. There are currently SAMSHA certified labs that have effectively shut down the majority of use of these kind of tampering agents with NON-DOT tests, the same should be true for DOT testing since the technology is available. I would not advise not adding this subject to the existing recommendations as this would only delay the opioid panels from being added.
The current DOT collector guidelines do not address electronic chain of custody forms in either training guidelines or in practice guidelines.
It's recommended that the collector must go through the DOT collector training using standard paper chain of custody forms, and that if the collector will be using electronic chain of custody forms, must have additional training from the vendor on how to properly process the electronic chain of custody form on-line. In addition, common errors include the collector dismissing the donor without providing a specimen without fully allowing for the 3 hour time frame because they are closing for lunch or for the day. This should be a collector error and fatal flaw. I also think unless the site can reliably provide male and female collectors, they should not be able to offer to do a DOT collection, since some observed collections will be initiated during the collection (i.e. specimen temp out of range) which cannot be predicted in advance. I think it's also a disservice to claim to offer DOT breath alcohol without having the confirmation(i.e. breath alcohol test) available at the site. The reason is while the clear majority of alcohol saliva tests are negative, when one is positive it most likely is for reasonable cause or post-accident scenario where the outcome is critical.
It would also be helpful to include in the observed collection procedure on how to handle a transgender collection. Most collectors agree that the "legal" sex that is registered on the donor's driver's license, however this is a thorny issue with many opinions, so would further recommend this subject have it's own rule-making period. I would also recommend that the opioid panel be flexible enough that the employer and/or MRO can order additional opioid testing not in the expanded panel (i.e. Fentanyl) as the drugs of abuse are constantly evolving and users will continue to change their drugs of abuse in order to avoid detection. ", "comment_id": "DOT-OST-2016-0189-0056", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0056", "comment_date": "2017-03-24T04:00:00Z", "comment_title": "Comment from Esther Miller", "commenter_fname": "Esther", "commenter_lname": "Miller", "comment_length": 4849}, {"text": "Timely submitted comments the Chamber of Shipping of America are attached here.
R/
Kathy J Metcalf
President and CEO
Chamber of Shipping of America", "comment_id": "DOT-OST-2016-0189-0041", "comment_url": "https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0041", "comment_date": "2017-03-21T04:00:00Z", "comment_title": "Comment from Chamber of Shipping of America", "commenter_fname": "Kathy", "commenter_lname": "Metcalf", "comment_length": 168}]}, {"id": "FDA-2019-P-1783", "title": "Requests that the FDA immediately impose a moratorium on all future approvals of new drug applications (NDAs) for new opioids or new opioid formulations.", "context": "2019-09-16T08:56:20Z", "comments": [{"text": "Everyone deserves fresh healthy produces on both both rich and poor communities on the city the people are living. Like in Atlanta neither you're living in Bankhead or Buckhead, both of them deserve equal fresh clean healthy produce and much more on their communities.", "comment_id": "FDA-2019-P-1783-0160", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0160", "comment_date": "2019-09-11T04:00:00Z", "comment_title": "Comment from Jean Pressoir", "commenter_fname": null, "commenter_lname": null, "comment_length": 272}, {"text": "To see how it was that the republicans in Pennsylvania dropped all information on opiate drug's overdose potential and physical addiction potential shows how this is all about the money, selling the drug to uneducated parties in order to deceive them about the drug's nature and dangers. Then in Ohio, a republican leader proposed to limit how many times addicts were to be brought back after an overdose to two times. See? They sell killer dope to us, then limit how many times we are to be brought back after an overdose; in an active addiction. And then plan on a person relapsing 7-10 times if a person has an abuse history. So clearly bringing back a person so affected parasuicidally "a couple of times" is certainly NOT getting the job that needs to be done, done; the services to accomplish that are not substantially out there adequate to the growing need(s). See also article The Mega Group, Maxwell's, and the Mossad on guns for drugs ops (1 of a four part series), child trafficking ops, black market body parts trade (UC-Berkeley Dept. of Anthropology-Organswatch). at www.mintpressnews.com, and large scale secret drug fueled mass murder operations carried out inside war crimes, like Operations Phoenix and Condor. See book The Phoenix Program, by Douglas Valentine and books by Alex Constantine. The first step in these programs is to cut the anti-poverty budgets, creating the original crisis, then lie yuge and say the economic crisis is caused by drug abusers and the homeless in a deliberate big lie program based on what is termed "projective Inversion";blaming the victim/survivors for what the nazi budget cutters, eerrr republicans actually did. Then too, see how opiate drug producers targeted areas that had a lot of consumption and overdoses for greater supplies when it was not used for medical purposes. Kentucky, West Virginia, Ohio, etc..This is clearly a "slow death" program; one of many run by the nazis, eerrr republicans. Harass, cut back benefits, cut benefits off completely-dead client. Just what the nazi doctor ordered. . . . Lyle Courtsal www.3mpub.com-Kissinger wants to reduce population by 2/5ths any means necessary. . . See also Gary Kohl's at www.duluthreader.com and Peter Breggin on "warehousing", rather than receiving care for conditions humanely. . .
PS What we also see is rather than an individual patient specific, patient centered interactive approach to pain management, etc., is instead a swinging between one professional sub-cultural extreme, enough pain pills for the pain and the addiction-no effective support then professional subculture swings to a complete cutoff of access to opiate pain pills that actually did work for the majority of patients out there; opiate medicine cut off completely (by Sessions); patient's situations much worse for those using opiates successfully than before. No more pain meds-patient in new much nastier crisis medically and is probably not getting adequate medical support with or without pain meds-next visit doctor 2 months away?!! ", "comment_id": "FDA-2019-P-1783-0381", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0381", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Lyle Courtsal", "commenter_fname": null, "commenter_lname": null, "comment_length": 3099}, {"text": "I urge the FDA to impose an immediate, temporary moratorium on new opioid approvals. The National Academies of Sciences, Engineering, and Medicine issued detailed recommendations for an improved opioid regulatory framework more than two years ago, but the FDA has failed to put this new public health framework in place. Until it does, the moratorium is urgently needed.", "comment_id": "FDA-2019-P-1783-0382", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0382", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Erik Schnabel", "commenter_fname": null, "commenter_lname": null, "comment_length": 370}, {"text": "I absolutely support this petition.", "comment_id": "FDA-2019-P-1783-0364", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0364", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Adrian Devlin", "commenter_fname": null, "commenter_lname": null, "comment_length": 35}, {"text": "I'm tired of having to worry about whether people are selling their opioid products instead of disposing of them properly. The whole problem needs to be controlled.", "comment_id": "FDA-2019-P-1783-0369", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0369", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Carol Caffrey", "commenter_fname": null, "commenter_lname": null, "comment_length": 169}, {"text": "I completely support Public Citizen's petition concerning this critical public safety issue.", "comment_id": "FDA-2019-P-1783-0383", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0383", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Paul Netusil", "commenter_fname": null, "commenter_lname": null, "comment_length": 96}, {"text": "I am calling on the FDA to stop approving new opioids until it has adopted the public health opioid regulatory framework recommended in 2017 by the National Academies.
The FDA has recklessly approved dozens of new opioids without adequately assessing either their effectiveness or the likelihood that new products will be diverted into illegal trade and make the opioid addiction crisis still worse. Its up to us to demand the agency impose a freeze on opioid approvals until it adopts a safer approval process.
I am urging the FDA to impose an immediate, temporary moratorium on new opioid approvals. The National Academies of Sciences, Engineering, and Medicine issued detailed recommendations for an improved opioid regulatory framework more than two years ago, but the FDA has failed to put this new public health framework in place. Until it does, the moratorium is urgently needed.", "comment_id": "FDA-2019-P-1783-0385", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0385", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Gloria Fooks", "commenter_fname": null, "commenter_lname": null, "comment_length": 905}, {"text": "There are enough drugs already that can KILL and maim people. STOP with the quick release of new ways to get addicted ", "comment_id": "FDA-2019-P-1783-0386", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0386", "comment_date": "2019-09-16T04:00:00Z", "comment_title": "Comment from Barbara Khajavi", "commenter_fname": null, "commenter_lname": null, "comment_length": 118}, {"text": "I support the Citizen Petition from Public Citizen to restrict the sale of opioids.", "comment_id": "FDA-2019-P-1783-0090", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0090", "comment_date": "2019-09-11T04:00:00Z", "comment_title": "Comment from Jeff Nein", "commenter_fname": null, "commenter_lname": null, "comment_length": 83}, {"text": "I support this petition.", "comment_id": "FDA-2019-P-1783-0117", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1783-0117", "comment_date": "2019-09-11T04:00:00Z", "comment_title": "Comment from Cherie Gaines", "commenter_fname": null, "commenter_lname": null, "comment_length": 24}]}, {"id": "ONDCP_FRDOC_0001", "title": "Recently Posted ONDCP Rules and Notices.", "context": "2024-01-18T08:27:34Z", "comments": []}, {"id": "FDA-2010-P-0082", "title": "Citizen Petition Regarding Extended-Release Morphine Sulfate Drug Products-CLOSED", "context": "2022-01-05T01:04:09Z", "comments": []}, {"id": "FDA-2017-P-6918", "title": "Requests that the FDA amend the FDA contraindication of codeine in children younger than 12 years old.; CLOSED", "context": "2023-08-14T08:50:58Z", "comments": [{"text": "How is this possible? Why would the FDA deny cough medicine to children? They are very ill, some terminal. This is ludicrous! Codeine has been around for approximately 80 years. Are you going after the sick, disabled children now? Do you realize how this makes you look? You appear to be monsters! Monsters of the type I have never encountered in my 60 years on this planet. CHILDREN!!!", "comment_id": "FDA-2017-P-6918-0020", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0020", "comment_date": "2018-07-09T04:00:00Z", "comment_title": "Comment from Dee Eeeenst", "commenter_fname": null, "commenter_lname": null, "comment_length": 386}, {"text": "This petition is well thought out and expressed. Please note that the persons signing this, for the most part, are not affiliated with a pharmaceutical company, thereby avoiding conflicts of interest.
The goal is simple: to allow physicians to prescribe codeine to pediatric patients under certain conditions.
Please consider these two points when evaluating this petition.", "comment_id": "FDA-2017-P-6918-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0019", "comment_date": "2018-07-09T04:00:00Z", "comment_title": "Comment from DeeAnn Visk", "commenter_fname": null, "commenter_lname": null, "comment_length": 393}, {"text": "When used in the correct patient populations, codeine with acetaminophen is a highly effective scheduled 3 agent. It would be a serious detriment to lose this drug in our arsenal when treating sickle cell patients. ", "comment_id": "FDA-2017-P-6918-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0018", "comment_date": "2018-07-09T04:00:00Z", "comment_title": "Comment from Melinda Tran", "commenter_fname": null, "commenter_lname": null, "comment_length": 216}, {"text": "I support this citizen petition.", "comment_id": "FDA-2017-P-6918-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0017", "comment_date": "2018-07-09T04:00:00Z", "comment_title": "Comment from Vicky Pratt", "commenter_fname": null, "commenter_lname": null, "comment_length": 32}, {"text": "Why are the children being forced to suffer, it's bad enough the government has tortured millions with the CDC" GUIDELINES". Why do these precious children have to suffer more. I beg you please change the way pain Is Treated today and let these children have some relief. I've lost all hope in humanity now I beg you change these awful rules.it's the only way and the right thing to do. TY for your time", "comment_id": "FDA-2017-P-6918-0021", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6918-0021", "comment_date": "2018-07-09T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 428}]}, {"id": "FDA-2017-P-0663", "title": "Requests that the FDA refrain from approving any IN naloxone drug application (whether an NDA or ANDA) for the emergency treatment of a known or\nsuspected opioid overdose until the FDA considers whether such application adequately addresses the reliability of IN naloxone in actual field use.", "context": "2017-06-30T13:06:12Z", "comments": []}, {"id": "FDA-2009-P-0325", "title": "Request that FDA Require Specifc Impurity Data & Bioequivalence Data to Generic Formulations of Subutex\u00ae Sublingual Tablets (2 mg & 8 mg Buprenorphine) & Suboxone\u00ae Sublingual tablets (2 mg/0.5 mg & 8 mg/2 mg Buprenorphine/Naloxone)-CLOSED", "context": "2022-01-05T01:03:48Z", "comments": []}, {"id": "FDA-2009-P-0227", "title": "To Take Action to Strengthen FDA Regulation of Controlled Prescription Drugs by Issuing a new Rule Mandating Classwide Risk Evaluation and Mitigation Strategies (REMS) for all Opioid Drugs - CLOSED", "context": "2022-01-05T01:03:43Z", "comments": []}, {"id": "FDA-2006-P-0279", "title": "ANDA Suitability for Oxycodone Hydrochloride Capsules, 5 mg; CLOSED 12/08/2015", "context": "2021-09-01T01:01:34Z", "comments": []}, {"id": "FDA-2005-P-0325", "title": "Temporary Recall of Approval of OxyContin and Palladone Removal From Market and Label Changes Limiting Indications to Severe Chronic Pain From Documented Peripheral Tissue Disease Potential - CLOSED", "context": "2021-09-01T01:01:24Z", "comments": [{"text": null, "comment_id": "FDA-2005-P-0325-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0325-0013", "comment_date": "2008-12-22T05:00:00Z", "comment_title": "Stephen G. Gelfand - Reply Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-P-0325-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0325-0012", "comment_date": "2008-12-22T05:00:00Z", "comment_title": "Kirk Van Rooyan, M.D. and Barbara Van Rooyan. - Reply Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-P-0325-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0325-0011", "comment_date": "2008-12-22T05:00:00Z", "comment_title": "Purdue Pharma LP - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}]}, {"id": "FDA-1986-P-0002", "title": "ACETAMINOPHEN 650MG & CODEINE PHOSPHATE 15MG ANDA SUITABILITY-CLOSED", "context": "2021-09-01T18:01:09Z", "comments": []}, {"id": "FDA-2008-P-0401", "title": "To Permit the Filing of an Abbreviated New Drug Application (ANDA) Suitability for Morphine Sulfate Tablets 5 mg, 10 mg, and 20 mg Referencing Roxane Laboratories, Inc. - WITHDRAWN", "context": "2022-01-05T01:03:19Z", "comments": []}, {"id": "DEA-2008-0012", "title": "Control of a Chemical Precursor Used in the Illicit Manufacture of Fentanyl as a List I Chemical", "context": "2014-01-10T15:20:39Z", "comments": []}, {"id": "FDA-2003-P-0185", "title": "ANDA to declare that drug prod Hydrocodone Polistirex & Chlo-CLOSED", "context": "2021-09-01T01:02:59Z", "comments": []}, {"id": "FDA-2005-P-0425", "title": "To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information", "context": "2021-09-01T01:01:28Z", "comments": []}, {"id": "FDA-2014-P-1383", "title": "Request That the FDA determine that an Abbreviated New Drug Application ANDA may be submitted for Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets in strengths of 4 mg/1 mg and 12 mg/3 mg", "context": "2023-06-12T15:44:23Z", "comments": []}, {"id": "FDA-2009-P-0388", "title": "Determine that Morphine Sulfate Concentrate Oral Solution in a strength of 20mg/mL is suitable for submission in an Abbreviated New Drug Application (ANDA)-CLOSED", "context": "2022-01-05T01:03:50Z", "comments": []}, {"id": "FDA-1993-N-0363", "title": "Levo-Alpha-Acetyl-Methadol Revise Conditions for Use", "context": "2021-09-01T18:00:53Z", "comments": [{"text": "see attached", "comment_id": "FDA-1993-N-0363-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0006", "comment_date": "2017-04-17T04:00:00Z", "comment_title": "Comment from COMPA", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "see attached", "comment_id": "FDA-1993-N-0363-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0004", "comment_date": "2017-04-17T04:00:00Z", "comment_title": "Comment from James L. Sorensen", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": null, "comment_id": "FDA-1993-N-0363-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0009", "comment_date": "2017-04-17T00:00:00Z", "comment_title": "Comment from American Psychiatric Association", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-1993-N-0363-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0010", "comment_date": "2017-04-17T00:00:00Z", "comment_title": "Comment from State of California Department of Alcohol and Drug Programs", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-1993-N-0363-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0013", "comment_date": "2017-04-17T00:00:00Z", "comment_title": "Comment from Sidney H. Schnoll", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": "see attached", "comment_id": "FDA-1993-N-0363-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0005", "comment_date": "2017-04-17T04:00:00Z", "comment_title": "Comment from BAART", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "see attached", "comment_id": "FDA-1993-N-0363-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0002", "comment_date": "2017-04-17T04:00:00Z", "comment_title": "Comment from Beth Israel Medical Center", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "see attached", "comment_id": "FDA-1993-N-0363-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0003", "comment_date": "2017-04-17T04:00:00Z", "comment_title": "Comment from Forest Tennant", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": null, "comment_id": "FDA-1993-N-0363-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-1993-N-0363-0007", "comment_date": "2017-04-17T00:00:00Z", "comment_title": "Comment from California Organization of Methadone Provide (COMP)", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}]}, {"id": "DOD-2012-HA-0117", "title": "Proposed collection; comment request (TriCase Case Management & Authorization System; OMB Control Number 0720-TBD)", "context": "2012-09-20T12:33:18Z", "comments": []}, {"id": "VA-2020-VHA-0023", "title": "AQ31-Proposed Rule-Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists", "context": "2021-12-13T15:35:34Z", "comments": [{"text": "Please see attached Word document. ", "comment_id": "VA-2020-VHA-0023-0021", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0021", "comment_date": "2021-01-05T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Evans, Joel", "commenter_fname": "Joel", "commenter_lname": "Evans", "comment_length": 35}, {"text": "Opioid addiction is an ever-present threat to individuals living in the United States of American and around the world. According to the National Institute on Drug Abuse, 128 Americans die each day from a drug overdose. The problem of opioid addiction and overdose has been an increasingly important issue in the United States over the past couple of decades. Public health professionals and governmental organizations have been working together to create initiatives and rulings that favor preventative and treatment services for individuals that are addicted to drugs. The problem of opioid dependence is one that was, in part, caused by the drug manufacturers and physicians of the 1990s. Addiction and overdose are problems that need to be addressed. The United States Department of Veterans Affairs is working to improve the health outcomes of veterans who are at risk for addiction and overdose due to opioids.
Many deaths related to opioid addiction are preventable with public health intervention. Drug addiction is a multifactorial health issue caused by a multitude of different situations. Individuals impacted by opioid addiction often lack sufficient social support systems, suffered previous serious injuries, and are victims of poor prescription practices. Without interventional activities, an addicted individual could end up dying from a drug overdose. There are currently several populations disproportionately impacted by opioid dependence and opioid overdose.
Several populations are more vulnerable to struggling with drug addiction. A specific population at an increased risk within the United States are veterans. The Department of Veterans Affairs has an entire unit dedicated to overcoming drug abuse in veterans. The organization states that veterans experience Post-Traumatic Stress Disorder (PTSD) as a result of their service to their country. These individuals are more susceptible to drug use. This increased use could pose threats to their lives. Additionally, as a person is exposed to more stressors, the more that negatively impacts their health outcome.
Opioids are powerful drugs. Many of them serve as integral aspects of pain-relieving treatment in the United States. However, there are drawbacks to these powerful compounds. According to the Centers for Disease Control and Prevention, in the 1990s, the number of prescriptions written out for opioids began to rise. A rise in prescriptive practices correlated with the increased mortality due to opioid overdose. Since the discovery of opioids as an effective treatment for pain management, there have been issues with abuse, addiction, and overdose. As a nation, the United States is currently trying to combat this public health crisis.
A rule recently proposed by the Department of Veterans Affairs dealt with opioid addiction in the veteran population. As previously noted, these individuals are at an increased risk of addiction and overdose with opioids. The proposed rule would eliminate copay requirements for veterans seeking help for opioid addiction. Additionally, copayments would not be required for the obtainment of opioid antagonists. Common opioid antagonists are Naltrexone and Naloxone. Drugs like Naltrexone and Naloxone act in opposition to opioids. Opioid antagonists allow for the reversal of the negative impacts of opioids. If using extended-release versions of these drugs, they can cost hundreds to thousands of dollars. Veterans are typically older Americans who are already on restricted incomes. Adding this expense could push their budgets to the max. Eliminating the copay for Naltrexone and Naloxone could not only reduce the cost burden for veterans but also save their lives.
The number one cause of opioid dependence is related to pain management. Veterans experience injuries that persist well after they return home. We must ensure they have access to all of the services that they need to live a happy and healthy life. These high-risk individuals should have adequate access to opioid antagonists. Veterans should also have access to counseling and educational information on the subject of opioid addiction. We must fight for those who fought for us!", "comment_id": "VA-2020-VHA-0023-0009", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0009", "comment_date": "2020-11-18T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Eckley, Kaitlyn", "commenter_fname": "Kaitlyn", "commenter_lname": "Eckley", "comment_length": 4228}, {"text": "Opioid overdose death rates in the veteran population have increased over 65% since 20101 which is of particular concern after noting the already increased risk veterans are placed at for developing comorbid mental health conditions. The Department of Veteran Affairs has many initiatives in place for combatting this problem, but there remains the issue of opioid use specifically as research is continuing to show that current efforts (such as decreasing prescription provision) are not sufficient in reducing this phenomenon. This proposed rule would eliminate the copays needed for veterans covered under the VA to access potentially life-saving drugs such as naloxone, an opioid antagonist that could bring an individual out of an active overdose.
While available without prescription, naloxone can cost individuals hundreds of dollars without insurance in some locations, and even with insurance can be costly. Previous research in the veteran population has shown that increased copays can decrease not only medication adherence, but medication seeking2. If the goal is to protect our veterans from the harm of prescription drug misuse, the answer shouldn’t be making it more difficult to access ALL medications, but instead making those that are helpful and potentially life-saving more accessible. The military experience, as researchers have described it, puts veterans at a unique risk for developing mental health conditions that adversely affect their daily life and can drive other inhibiting factors such as homelessness or poverty3. The logical and data-based solution that exists to help prevent these factors from interfering with an individual’s ability to access necessary healthcare is to eliminate copays when capable3,4.
We see that the opioid epidemic is showing no signs of slowing down and we know that since 2017 there have been staggering trends in overdose fatalities even without considering veteran status. Adding this in, it seems only logical that this step, eliminating copays for opioid education resources and antagonist agents, be taken to protect those that spent their life protecting us. This proposed rule does, however, indicate that these waivers would be applicable to those indicated as “high risk” and does not have current definition about how those identifications would be made, which is where I think there should be further discussion. Previous research has discussed the different conditions that are unique to veterans regarding opioid use as well as how veterans are at a higher risk level than many for disabling conditions upon returning from service3. This prompts me to question the necessity of this inclusion for this proposed rule. Why must an already-established high-risk individual be re-classified into a second tier of high-risk to access resources that should be available to all? What separates risk level when you are involving an already high-risk group of people? Why do we need to sever the resources within this population? Aren’t all at a high enough risk to justify their deserving free resources to protect their health?
This proposition also includes leverage about “education.” I think this is an extremely valuable consideration and am so glad to see that the VA is wanting to educate those at risk of opioid misuse on ways to prevent overdose as well as how to respond in the event that those efforts aren’t successful. That said, why are these services not currently being provided, and if they are to be in the future, why is a copay even necessary? What message does that send our veterans? This proposed rule about eliminating copay requirements for opioid antagonists and educational services about their use is extremely encouraging and a giant leap forward in my view. What I want to focus on moving forward is why we are still considering only providing this accessibility to some, and not to all. Is it necessary to classify at-risk individuals by who has the most risk, when in reality they all are in need of help? Is it really that much of a stretch to provide this service to all veterans? Can we not work together for all and not just for some?
1.https://doi.org/10.1016/j.amepre.2019.01.016
2.https://doi.org/10.1161/circulationaha.108.783944
3.https://doi.org/10.3109/10826084.2013.796991
4.https://doi.org/10.1161/circulationaha.108.829655
", "comment_id": "VA-2020-VHA-0023-0008", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0008", "comment_date": "2020-11-17T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Caldwell, Kyle", "commenter_fname": "Kyle", "commenter_lname": "Caldwell", "comment_length": 4602}, {"text": "The Opioid Crisis in the United State is getting worse every day. Studies show that individuals with mental health illnesses have a higher chance of developing comorbid conditions like substance use disorders. Risk factors for mental health illnesses consist of both stress and trauma (NIH Comorbidity: Substance Use Disorders and Other Mental Illnesses DrugFacts) that are commonly found in the Military experience. "The 2014 JAMA Psychiatry study found the rate of PTSD to be 15 times higher than civilians." (NAMI Veterans and Active Duty) Given this information, it is the duty of the Department of Veteran Affairs to eliminate copays for Opioid Antagonists and Education on Use of Opioid Antagonists free of cost", "comment_id": "VA-2020-VHA-0023-0006", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0006", "comment_date": "2020-11-12T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Capstick, Casey", "commenter_fname": "Casey", "commenter_lname": "Capstick", "comment_length": 729}, {"text": "The elimination of copayment for opioid antagonist is critical for the progress in the United States. More specifically it is needed to prevent overdose among veterans and people affiliated with the Dept. of Veteran Affairs. Eliminating the copayment for opioid education will benefit people of all backgrounds but especially for people who may not have the funds to educate themselves on the dangers of opioid abuse. Proving the free education will prevent future overdoses and also spread awareness of the negative side effects of drug abuse. I would change the wording in the proposal from antagonist to something that is more relatable and not so demeaning to people who will interpret it the wrong way. Other than that, the proposed federal rule should be passed and will be very beneficial to society as a whole. ", "comment_id": "VA-2020-VHA-0023-0003", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0003", "comment_date": "2020-11-09T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Anonymous", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 819}, {"text": "Medical protocols that govern copayments to correspond with current legislative requirements. VA would be eradicating the copayment prerequisite for opioid antagonists equipped to veterans. These veterans who are at abnormal risk of overdose of a explicit medication or substance in order to setback the result of such an overdose. VA would also explain that no copayment would be mandatory for providing of learning on the use of opioid antagonists. The recommended rule would be a crucial part of VA's challenges to help veterans at an extreme risk of overdose.", "comment_id": "VA-2020-VHA-0023-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0004", "comment_date": "2020-11-09T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Cabrera, Eugenia", "commenter_fname": "Eugenia", "commenter_lname": "Cabrera", "comment_length": 567}, {"text": "While Public Law 114-198, sec. 915 and Public Law 114-223, sec. 243 already have eliminated co-payments for Veterans regarding Opioid antagonists, and the education of utilizing those lifesaving antagonists this rule would make the law clear in the VA's co-payment regulations, 38 CFR 17.108 and 17.110. This measure is critical in creating cross-governmental cohesion in the fight against the opioid crisis in our Veteran populace. According to the Veteran's Administration, the use of Opioids by the VA has decreased sustainably in the past several years, which has led to a decline in Opioid use and addiction amongst our Veterans. The availability and education on the use of Opioid antagonists would only further this fight against addiction and potentially save the lives of those suffering from Substance Abuse Disorder. The amendment to Section 17.110 paragraph (c)(12) adding a clear definition to whom is characterized by "high risk" is also an essential step in ensuring that any Veteran needing these measures will have the availability of lifesaving opioid antagonists afforded to them.
This proposed rule to amend 38 CFR 17.108 and 17.110 only solidifies the message of a united front against the opioid crisis in our Veteran community, and it secures that the policies enacted by Public Law 114-198, sec. 915 and Public Law 114-223, sec. 243 remain intact. ", "comment_id": "VA-2020-VHA-0023-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0005", "comment_date": "2020-11-09T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule - Kleisch, Suzanne", "commenter_fname": "Suzanne", "commenter_lname": "Kleisch", "comment_length": 1400}, {"text": "To Whom it May Concern,
I am a graduate student of public policy currently studying the rulemaking process. Thank you for the opportunity to contribute to this process; I hope my comment is useful in your considerations. My comment provides further support of your removal of the copayment burden for “high risk” veterans, a suggestion to strengthen the impact of this rule in conjunction with other VA programs, and an inquiry into your impact analysis lack of explanation on the impact of the expected loss of revenue on other veteran services.
Firstly, I agree with your course of action in codifying into regulation the two statutes that prompted this proposed rule. Removing the copayment requirement for high-risk individuals for receiving education about their medication and antagonist usage as well as for receiving treatment for an overdose itself will incentivize high-risk veterans’ usage of these services. This will reduce the risk of death from overdose by increasing the rate of overdose intervention as demonstrated by the VA’s assessment of service usage for high-risk individuals from 2017 to present (1). Since the launch of the VA’s Opioid Safety Initiative in 2013, the number of veterans prescribed opioids and the rate of opioid overdoses from prescription opioids has been decreasing. This program has multiple layers such as education, alternative pain management, risk mitigation strategies, and addiction treatment (2) and proved to be successful in reducing the opioid crisis in the veteran population however, the program is simply a starting point. This new rule, along with the Public Law statutes referenced above, further the goals of the OSI program, and the Comprehensive Addiction and Recovery Act of 2016, and are aligned with current best practices for treating chronic pain, mediating mental health comorbidities, and reducing the risk of addiction and overdose in the veteran population (3,4). Experts in the field have identified the removal of financial barriers to be a key factor in a person’s recovery from opioid dependence (4). By addressing the burden and deterrence of a copayment, this rule eliminates a barrier to treatment and education opportunities for many high-risk veterans who would otherwise forgo these services.
Education and outreach can help reduce self-stigmatization from internalized public stigmatization which is a leading factor in treatment deterrence for high-risk individuals (5). I believe this rule should incorporate wording ensuring outreach to identify high-risk veterans, encourage educational outpatient visits, and follow-up before and/or after both outpatient and inpatient visits for treatment and education. Not only will this increase the number of veterans who receive antagonist prescriptions, but these efforts will also aid the VA in tracking the most at risk of the high-risk population, aid in the dissemination of pain management alternatives, and overall reduce the risk of opioid misuse and overdose events. Outreach has proven effective in several studies conducted all over the US for people suffering with Opioid Use Disorder and is a main factor is reducing repeat overdose events (6,7,8,9,10). These outreach practices are already occurring in the VA and should be folded into the regulation to ensure their continuation as outreach is an integral part of increasing the effectiveness of this rule’s stated goal.
One aspect of the impact analysis that I am concerned about is the projected loss of revenue of >$150,000 with increases for each year of this rule’s existence due to the copayment exemptions. The “impact” analysis did not state where this revenue stream would be diverted from internally and how this may impact other veteran services of equal or greater importance. Does the VA plan to apply for a grant under the Food, Drug, and Cosmetic Act for the emergency treatment of opioid overdose (11)? One of these grants can offset at least $200,000 of antagonist costs which is greater than the yearly projected loss of revenue from this rule.
Thank you for considering my public comment in your review of the proposed rule Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists.
Best regards,
Mina Puig
Master of Public Policy and Administration Candidate
University of Massachusetts Amherst
Please see attached for list of referenced material.", "comment_id": "VA-2020-VHA-0023-0017", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0017", "comment_date": "2020-12-03T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Puig, Mina", "commenter_fname": "Mina", "commenter_lname": "Puig", "comment_length": 4521}, {"text": "The U.S. Department of Veterans Affairs’ (VA) proposal for this rule change is a great idea to remove the barriers to treatment faced by veterans. Removing copays and providing education are two strategies that could potentially improve the health outcomes of veterans battling opioid use disorder (OUD) which leads to opioid overdoses. We must combat the factors that may deter veterans from receiving treatment. This proposed rule to, provide education on the use of opioid antagonists and to exempt co-payments, showcases the VA understands the need for prevention intervention strategies to remove the burden on the veteran population and their families.
According to the Pain Management Opioid Safety VA Educational Guide (2014), veterans are more likely to die from accidental overdose than non-veterans.1 Research shows that veterans are prescribed higher doses of opioids and receive prescriptions for sedatives concurrently when suffering from Posttraumatic Stress Disorder (PTSD).1 This combination increases the likelihood for an accidental overdose.1 The National Institute on Drug Abuse found that barriers to opioid antagonist include stigma, lack of education, and lack of patient interest.2 Other research found that logistics, treatment experiences and beliefs, and knowledge of OUD medications also contribute to the lack of opioid antagonist use by patients and providers.3 The stigmas associated with OUD and high out-of-pocket cost were the most common barriers for patients.3
A common drug to reverse the effects of opioid intoxication is naloxone, commonly known as Narcan. In 2013, the Substance Abuse and Mental Health Services Administration started to recommend providers prescribe this drug to patients taking opioids.4 The cost of Naloxone product have been increasing since 2009. Currently the version manufactured by Kaleo has increased from $690.00 USD in 2014 to $4,500 USD in 2016.4 This life saving drug can cost a veteran hundreds of dollars with insurance and be even more costly without it. The goal should be to improve the health outcomes of all veterans. Making sure they can afford their medications is one way to do this. Removing the co-payments from inpatient hospital care, outpatient medical care, and for medications will remove the barrier veteran’s face when trying to receive care. A large majority of veterans deal with homelessness and poverty after service. It is understandable that these veterans will not have insurance that will cover these treatments.
The lack of knowledge about OUD medications contributes to the absence of opioid antagonist use by patients and providers. Research found that the lack of knowledge pertained to where/how to get treatment and negative views of OUD medications.3 Providing education will give veterans a sense of involvement and control over their treatment. Educating on the use of opioid antagonists to reverse the effects of overdoses of specific medications or substances will improve the health literacy of veterans.
With the epidemic on opioid overdose continuing to rise it is important that we create legislation to combat it for the most at risk populations. Veterans volunteer their lives and time to protect the United States and it is our duty to protect them when they return home. Many veterans suffer from injuries, both physical and mental, while in service to this country, that lead to their prescription and addiction to opioids. They come back from war and suffer from stress, anxiety, pain, trauma, which tarnishes their mental health. The proposed rule by the VA to eliminate co- payments for inpatient hospital care, outpatient medical care, and for medications and providing education on opioid antagonists gives us the opportunity to do just this. As a daughter to two veterans and a family member to multiple veterans from varies branches of the military I believe this proposed rule will be impactful to veterans battling OUD.
References
1.Pain Management Opioid Safety VA Educational Guide . U.S. Department of Veteran Affairs ; 2014.
2.NIDA. Substance Use and Military Life DrugFacts. National Institute on Drug Abuse website. https://www.drugabuse.gov/publications/drugfacts/substance-use-military-life. October 23, 2019 Accessed November 18, 2020.
3.Mackey K, Veazie S, Anderson J, Bourne D, Peterson K. Evidence Brief: Barriers and Facilitators to Use of Medications for Opioid Use Disorder. U.S. Department of Veterans Affairs ; 2019.
4.Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone — Risks to Efforts to Stem Overdose Deaths. New England Journal of Medicine. 2016;375(23):2213-2215. doi:10.1056/nejmp1609578
", "comment_id": "VA-2020-VHA-0023-0013", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0013", "comment_date": "2020-11-18T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-Thomas, Patricia", "commenter_fname": "Patricia", "commenter_lname": "Thomas", "comment_length": 4895}, {"text": "See attached file(s)", "comment_id": "VA-2020-VHA-0023-0018", "comment_url": "https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0018", "comment_date": "2020-12-04T05:00:00Z", "comment_title": "Comment on AQ31-Proposed Rule-NAMI", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}]}, {"id": "FDA-2017-N-5608", "title": "Opioid Policy Steering Committee", "context": "2018-03-08T11:28:23Z", "comments": [{"text": "Please stop this witch hunt!!! I hope and pray none of you ever have to live like I do!!! If these "guidelines" were put out just to family practice Dr's then why has no one stepped up to tell these pain specialists to continue treating their pain pts... it's heroin killing people!!! You are taking away someone's only ability to function, without my meds I can't be a good wife and/or mother, I've done back and neck injections and they don't help with my chronic everyday pain, I did physical therapy until it stopped working, these meds weren't my first choice but they gave me my life back and now you're literally killing people because they see no hope anymore and they kill themselves because the pain is too much to handle, I'm curled up in the fetal position when my pain isn't under control and not able to take care of my family and bawling my eyes out!!! The state and/or government shouldn't be this involved in a Dr caring for their patient and no two patients are the same either, it's not a one size fits all ", "comment_id": "FDA-2017-N-5608-0155", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0155", "comment_date": "2017-11-13T05:00:00Z", "comment_title": "Comment from Tera Dabb", "commenter_fname": null, "commenter_lname": null, "comment_length": 1085}, {"text": "Hello, I am a medical professional, chronic pain sufferer and concerned citizen. It is well-known that the current crisis is fueled by heroin and illicit fentanyl more than pain medications and that we are repeating history. When we shut the pill mills down without offering any help to the patients who used them, we created a heroin epidemic that is the main source of overdoses today. Now, we are cutting off legitimate pain patients in the same manner without seeing the harm that does. After being abruptly cut off, these patients are in immense, unbearable pain and either commit suicide or buy fentanyl-laced prescription medications from street dealers, which causes them to overdose. Again, we are contributing to the opioid epidemic with short-sighted and overreaching policies.
Doctors are no longer prescribing these medications like they did in the past and are stopping entirely in some cases due to fear. We do not put the blame on a doctor if their diabetic patient goes against medical advice and is harmed due to noncompliance, yet we continue to prosecute pain management doctors when their patients harm themselves by going against medical advice. Why?
When we do actually get treatment for chronic pain patients who have been cut off, we put them on opioid maintenance medications like Suboxone. So, we essentially take them off of their opioid maintenance program just to put them on a new, more expensive one and treat them like criminals. Again, why?
The only way that we are going to solve this crisis is by focusing on the real problem: Addiction. Until we overhaul our addiction treatment and make it more affordable, less confusing and more effective, we will always have a problem with opioids. We need to stop focusing so much on legitimate patients who require these medications to be productive members of society and instead focus on helping those who are addicted.
It does not matter how many guidelines or policies or laws you make regarding pain medications, none of them will do any good. So far, in fact, they have really only made things worse. Please, for the sake of Americans across this country, begin focusing your efforts and money on addiction treatment that actually works. Only then will anything change.
Thank you. ", "comment_id": "FDA-2017-N-5608-0156", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0156", "comment_date": "2017-11-17T05:00:00Z", "comment_title": "Comment from Hillary B.", "commenter_fname": null, "commenter_lname": null, "comment_length": 2314}, {"text": "After numerous surgeries over the years for severe endometriosis, I was left with chronic pelvic pain due to scar tissue (that is aggravated by prolonged standing) and a condition called Pudendal Neuralgia (nerve damage that causes severe pain in the groin, vaginal and anal area with any amount of sitting) making it unbearable for me to sit for longer than 20 minutes. In fact, I had to give up a good government job because of the pain and was largely bed-ridden until I got into a comprehensive pain management program. For the past twelve years my pain has become manageable, and my life restored to some level of normalcy, with a number of pain medications that include opioids. The dosage is low (from 10mg to 30mg of Oxycodone per day) and I am permitted to take them "as needed", up to the aforementioned maximum dose, since my pain level varies from day to day depending on the nature and extent of my activity. I would like to point out, however, that my dosage has not changed in the entire twelve years I have been on this treatment regimen. Like so many other chronic pain sufferers, I do not...or should say dare not...abuse these medications as they mean the difference between a life worth living or wishing to die due to severe daily pain and activity restrictions. While illegal drug abuse and addiction is certainly a situation that needs to be addressed, please DO NOT punish those of us who depend on these medications for chronic pain relief by imposing unreasonable regulations that tie the hands of the responsible and ethical medical professionals running comprehensive programs of carefully monitored pain management...such as the one I attended until the new burdensome regulations made it impossible for them to continue their practice and they were forced to close down. ", "comment_id": "FDA-2017-N-5608-0247", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0247", "comment_date": "2017-11-28T05:00:00Z", "comment_title": "Comment from Janice H.", "commenter_fname": null, "commenter_lname": null, "comment_length": 1817}, {"text": "Is it necessary, is it safe, to include acetaminophen to every hydrocodone pill? Why can't you release an acetaminophen-free drug to reduce liver damage?", "comment_id": "FDA-2017-N-5608-0251", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0251", "comment_date": "2017-11-28T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 158}, {"text": "I have have four back surgeries and have been on and off opiates for over 30 years. I all that time I have stayed around the same dose of my opiate medication for the past 10 years even though my back has gotten much worse. As you can image I have have had many non-FDA approved epidural (which none worked) NSAID's that gave me 3 bleeding ulcers and 3 nights in ICU, PT, acupuncture,biofeedback and all other types of treatment, creams and braces. What I have found that allows me to get out of bed so I can live on my own is my opiate medication. My medication also helps me get to the store, helps me stand to fix my meals, exercise to keep my weight down and then to have enough relief to sleep when it is time too. The result that have been used have been faulse and we all know this is about money. Meanwhile you should ask you this question since these medications are so hard for people who really need them to get them prescribed to them why is more people dying each year from opiate overdoses? Basically the more the government gets involved in taking pain medication away from chronic pain patient and punsihing doctors who are treating us the more people who have died and will continue to do so. Get rid of the CDC requirement for chronic pain patients.
Below is what I deal wih every day", "comment_id": "FDA-2017-N-5608-0357", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0357", "comment_date": "2017-12-12T05:00:00Z", "comment_title": "Comment from Jenifer Markoe", "commenter_fname": null, "commenter_lname": null, "comment_length": 1310}, {"text": "The Abuse Deterrent Coalition has attached it's comment to this submission.", "comment_id": "FDA-2017-N-5608-0557", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0557", "comment_date": "2017-12-27T05:00:00Z", "comment_title": "Comment from Abuse Deterrent Coalition", "commenter_fname": null, "commenter_lname": null, "comment_length": 79}, {"text": "Please work on making more medication like Ultram and Nucynta, which are less likely to cause addiction, but still help chronic pain patients to function. Don't just turn your back on chronic pain patients without offering a solution. Please keep in mind that chronic pain patients are not the enemy, are not all abusers, misusers. Please keep chronic pain patients and their daily agony in mind when trying to solve this issue. Denying people relief who are in extreme pain is probably why a lot of people turn to obtaining them illegally. Yet, many doctor's offices are doing just that, and offering no other solutions. That seems like it will just make the problem even worse, not better. And forcing people to suffer to an extreme because of someone else's actions seems cruel.", "comment_id": "FDA-2017-N-5608-0394", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0394", "comment_date": "2017-12-19T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 793}, {"text": "People that are suffering from chronic pain such as Complex Regional Pain Syndrome which there is no cure for and is rated the highest pain level on the McGill Pain Scale are suddenly being told by their pain management doctor's that their dose of pain meds will be lowered or are being cut off cold turkey. People with this disease are not abusing their meds, they are urine tested. These meds make it able for them just to get out if bed. It's not fair that the doctor's have to be afraid of losing their licence's. They should not be told how to treat their patients.This disease Complex Regional Pain Syndrome is known as the Suicide Disease because people can't take the pain anymore. It affects all the limbs, internal organs and much more. You have no idea how many have taken their lives already. People in their 20's, mother's and father's, and many more. If the FDA and the Center for Disease Control keep dictating these rules to pain management doctor's there is going to be a lot more suicides. We should not have to be punished for the real drug addicts. We do not choose to have this disease and should not have our pain meds be taken away. I know of hundreds already going through this. The pain management doctor's should be able to treat their patients as they seem fit. Thank you", "comment_id": "FDA-2017-N-5608-0461", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0461", "comment_date": "2017-12-21T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 1338}, {"text": ""A one size fits all" dosing limit on opioids cannot be established. It fails to take into account the variations in individuals such as their condition, level of pain, genetic drug metabolism differences, and differences in ability to absorb in the GI tract. What suits one will never suit all. This needs to be left between the doctor and the patient to establish what is safe and effective for that individual and their needs.
I am a multiple rare disease patient, who suffers from severe intractable pain caused by my conditions. I have Adhesive Arachnoiditis, Ehlers-Danlos Syndrome, Chiari Malformation 1.5, cerebellar slumping, CRPS, and chronic spontaneous cerebrospinal fluid leaks.
A year and a half ago, my own pain management group forceable tapered all patients down to 90 mme. This took my own dosage, which I had been stable at for 8 years, down by 2/3rd. My pain became so severe that I could no longer function; I could not sleep, and when I did I had nightmares because of my pain. I could not even think; the pain was like a roar, and it drowned out even my own thoughts. It was not only terrible mentally; suffering that level of pain 24 hours a day had serious consequences for my physical health. The stress on my body caused my conditions to progress must faster, which meant losing the use of my arm and hand. I eventually finally left that pain practice when I reached a breaking point, and was very lucky to find a doctor willing to treat me as an individual. At that point, the constant stress of high pain had caused me to go into adrenal fatigue, and my cortisol level was close to 0. I had literally burnt out my adrenals, trying to withstand an inhuman level of suffering. Had I not gotten proper treatment for my pain at that time, I may have died.
I tell you my story as an example of why arbitrary dosage limits are harmful. Access to effective pain treatment must be preserved for chronic patients.
", "comment_id": "FDA-2017-N-5608-0490", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0490", "comment_date": "2017-12-22T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 1973}, {"text": "The majority of chronic pain patients use their meds as prescribed. We deserve to be treated with respect. Please stop taking our meds away from us. This will only cause more suicides and more people to turn to street drugs for help. ", "comment_id": "FDA-2017-N-5608-0555", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0555", "comment_date": "2017-12-27T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 234}]}, {"id": "FDA-1993-P-0018", "title": "ANDA Morphine Sulfate controlled release capsules 15,60,mgs-CLOSED", "context": "2021-09-01T18:00:25Z", "comments": []}, {"id": "CNCS-2021-0011", "title": "Opioid Recovery Coach Model Bundled Evaluation", "context": "2021-05-17T16:03:33Z", "comments": []}, {"id": "FDA-2006-P-0016", "title": "Risk Management Program for Fentanyl Products-CLOSED", "context": "2021-09-01T01:01:18Z", "comments": []}, {"id": "FDA-1981-N-0248", "title": "Revoke Exemption for Prescription Drugs Expectorants; CLOSED", "context": "2021-09-01T18:05:11Z", "comments": []}, {"id": "FDA-2003-N-0396", "title": "Risk Management Plans for Opiate Analgesic Drug Products with particular attention to modified-release products", "context": "2021-09-01T01:03:17Z", "comments": []}, {"id": "DEA-2017-0011", "title": "Schedules of Controlled Substances: Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl into Schedule I", "context": "2021-12-02T01:00:51Z", "comments": []}, {"id": "DEA-2018-0002", "title": "Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder", "context": "2022-04-02T01:07:02Z", "comments": []}, {"id": "FDA-2010-P-0012", "title": "Permit The Filing Of An Abbreviated New Drug Application for Morphine Sulfate Injection, 25 mg/mL (Preservative Free), Packaged In A 50 mL And A 100 mL Single Dose Vial-CLOSED", "context": "2022-01-05T01:03:55Z", "comments": []}, {"id": "FDA-2004-P-0096", "title": "ANDA Suitability for Acetaminophen, Butalbital Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg-CLOSED", "context": "2021-09-01T01:02:10Z", "comments": []}, {"id": "DEA-2019-0014", "title": "Schedules of Controlled Substances: Placement of Cyclopropyl Fentanyl, Methoxyacetyl fentanyl, ortho-Fluorofentanyl, and para-Fluorobutyryl Fentanyl in Schedule I", "context": "2021-12-02T01:00:59Z", "comments": []}, {"id": "FDA-2017-P-0428", "title": "Requests that the FDA refrain from approving any intranasal naloxone drug application until the FDA addresses its reliability in the field", "context": "2017-02-10T07:24:32Z", "comments": []}, {"id": "FDA-2006-P-0278", "title": "ANDA Suitability for Oxycodone and Acetaminophen drug product in an orally disintigrating form - CLOSED", "context": "2021-09-01T01:01:34Z", "comments": []}, {"id": "FDA-2002-P-0167", "title": "Abbreviated new drug application (ANDA)7.5 mg hydrocodone-CLOSED", "context": "2021-09-01T01:03:07Z", "comments": []}, {"id": "FDA-2002-P-0291", "title": "Request for immediate final approval of tramadol Hydrochlori-CLOSED", "context": "2021-09-01T01:03:14Z", "comments": []}, {"id": "FDA-1985-P-0002", "title": "ANDA SUITABILITY RE OXYCODONE HYDROCHLORIDE/ACETAMINOPHEN-CLOSED", "context": "2021-09-01T18:05:15Z", "comments": []}, {"id": "FDA-2017-P-1911", "title": "Request that the FDA ensure follow on products citing BUTRANS as the reference listed drug are as safe and effective as BUTRANS. CLOSED", "context": "2017-07-21T12:33:01Z", "comments": [{"text": "This war on "opioids" is actually a war on chronic incurable diseases. A war on chronic pain disease patients who benefit from opioid medications. Medications that enable millions of Americans relief of chronic debilitating pain associated with these diseases.
The fiction, widespread hysteria and distorted truths about this "opioid epidemic", is killing legitimate chronic pain disease patients who use their medications responsibly. We are patients.
100 million Americans have one or more chronic incurable pain Diseases. As the CDC, DEA, FDA, Medicaid and Medicare, and numerous other government agencies, are blaming Doctors for the over prescribing of opioid medication. NOBODY, is looking at or reading the statistics from chronic pain disease patients. How about NOT addressing these drugs as dangerous and addictive. When all else fails: physical therapy, exercise, over the counter medications and numerous injections etc, we chronic pain disease patients, are left with one option to help us cope, opioid pain medication. Lets address this medication as lifesaving and medically necessary for the million of Americans with chronic diseases. Chronic pain is a disease. Chronic pain disease patients are now the epidemic. The addiction rate of chronic pain disease patients is .02-.6 %. We do not misuse or abuse our medications.
No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against, by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our Dr's are afraid to treat us humanely, ethically and adequately. We have a disease that medication is readily accessible and beneficial to us and we are being denied. We, pain patients, are being discriminated against, due to people who abuse illegal heroin and illegal fentanyl. This is a direct hunt for Doctors who prescribe life saving medication, for pain disease patients, that benefit from them. We have our privacy invaded, we no longer are able to have doctor/patient confidentiality. We now have insurance agencies, pharmacists, and other government agencies in our physicians offices, monitoring, prosecuting and policing our physicians.
Though the statistics show a reduction in, opioid medications distributed, due to the CDC guidelines, death rates of overdoses from illegal opioids is rising.
The specific causes of deaths also needs to be closely investigated. The opioid in the person's system needs to be specified. Was it an illegal opioid, was it opioid medication specifically for that person, was there other drugs or alcohol involved? These statistics need to come out. These Government agencies do not want that information out, due to the fact that this "opioid epidemic", would then be debunked.
Let's put the shoe on the other foot. Restricting or taking away our medications is like FORCING people who do not want this medication to take it. One day those against these medications will need them but they will be denied.
We have a chronic disease. We want to be able to take care of our homes, our children, our selves, as much as possible. Without access to these life saving medications, we are unable to do so. We want to live, not just exist in pain 24/7.
We need the government agencies to look at the real statistics, not the hand picked. These agencies are not physicians. They are trying to doctor us, patients, without a medical license. They are also trying to police our physicians. This is a war on a disease, medications, physicians and patients.
We, chronic pain disease patients, need help. All the headlines, topics and stories on how opioids are bad and how people are abusing, misusing, overdosing, becoming addicted or dying from them. We need to look at the good they do and how they help our disease of chronic pain and the million of Americans who use them for some relief.
The government needs to put the focus on illegal drugs coming into, being manufactured and distributed in this country, illegal fentanyl, illegal heroin, methamphetamine, cocaine and all other ILLEGAL DRUGS. Not the legally prescribed and medically necessary medications we patients need. We chronic pain disease patients need help, but we are helpless due to the government and government agencies. There is stigma, scrutiny and discrimination against us due to a category of medications we desperately need and benefit from, opioid medications.
WE ARE PATIENTS NOT ADDICTS! !", "comment_id": "FDA-2017-P-1911-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-1911-0004", "comment_date": "2017-07-21T04:00:00Z", "comment_title": "Comment from Candi Simonis", "commenter_fname": null, "commenter_lname": null, "comment_length": 4632}]}, {"id": "FDA-2004-P-0162", "title": "ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen", "context": "2021-09-01T01:02:12Z", "comments": []}, {"id": "FDA-2000-P-0580", "title": "Oxycodone hydrochloirde/acetaminophen tablet 2.5mg/400mg; 5.0-CLOSED", "context": "2021-09-01T02:01:57Z", "comments": []}, {"id": "FDA-1998-P-0018", "title": "Drug products containing oxycodone hydrocloride tablet suitable-CLOSED", "context": "2021-09-01T18:02:54Z", "comments": []}, {"id": "DEA-2023-0106", "title": "Dispensing of Narcotic Drugs to Relieve Acute Withdrawal Symptoms of Opioid Use Disorder (DEA702)", "context": "2023-09-22T15:24:15Z", "comments": []}, {"id": "FDA-2013-P-1711", "title": "Refrain From Submitting the Stated Recommendation to HHS to Reclassify Hydrocodone Combination Products That Contain Hydrocodone Bitartrate in a Strength That is Lower Than 5 mg in Strength Into Schedule II", "context": "2017-03-21T09:22:03Z", "comments": [{"text": "I represent The Hawaii academy of Physician Assistants, a constituent organization of the AAPA. We work in a state where PAs are not yet authorized to prescribe Schedule II medications. The Drug Enforcement Administration’s (DEA’s) proposal (Docket No. DEA-389.” ) to reclassify hydrocodone combination products from Schedule III to Schedule II will affect us and the patients we serve. If implemented, the proposed rule will restrict PAs from prescribing hydrocodone combination productions in states where they do not yet have prescribing authority for Schedule II drugs. Reclassifying the medications will impose additional burdens on all patients who need these medications to manage severe pain.
We are opposed to this change and request that hydrocodone not be reclassified as a Schedule II drug.
Fielding Mercer, PA-C
President
Hawaii Academy of Physician Assistants
", "comment_id": "FDA-2013-P-1711-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2013-P-1711-0004", "comment_date": "2017-03-21T04:00:00Z", "comment_title": "Comment from Fielding Mercer", "commenter_fname": null, "commenter_lname": null, "comment_length": 928}]}, {"id": "FDA-2008-P-0127", "title": "Declare that the drug product, Acetaminophen, and Codeine Phosphate Effervescent Tablets in strengths of 500 mg/15 mg, 500 mg/30 mg, and 500 mg/60 mg, are suitable for consideration in an abbreviated new drug application", "context": "2022-01-05T01:03:08Z", "comments": []}, {"id": "FDA-2002-P-0003", "title": "Seek immediate final approval of generic tramadol hydrochloride-CLOSED", "context": "2021-09-01T01:02:57Z", "comments": []}, {"id": "CMS-2020-0060", "title": "Value in Opioid Use Disorder Treatment Demonstration (CMS-10728)", "context": "2021-04-04T01:05:32Z", "comments": [{"text": "See attached file(s)", "comment_id": "CMS-2020-0060-0009", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0009", "comment_date": "2020-07-29T04:00:00Z", "comment_title": "Comment on CMS-2020-0064-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "How do an FQHC sign up to participate. Please advise.
Thanks,
", "comment_id": "CMS-2020-0060-0002", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0002", "comment_date": "2020-07-14T04:00:00Z", "comment_title": "Comment on CMS-2020-0060-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 80}, {"text": "Please see attached comments from the American Association of Nurse Practitioners on CMS-10728 Value in Opioid Use Disorder Treatment Demonstration. ", "comment_id": "CMS-2020-0060-0007", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0007", "comment_date": "2020-07-29T04:00:00Z", "comment_title": "Comment on CMS-2020-0064-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 149}, {"text": "See attachment re CMS-10728 Value in Opioid Use Disorder Treatment Demonstration", "comment_id": "CMS-2020-0060-0006", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0006", "comment_date": "2020-07-29T04:00:00Z", "comment_title": "Comment on CMS-2020-0063-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 80}, {"text": "Please see the attached letter from the American Society of Addiction Medicine (ASAM).", "comment_id": "CMS-2020-0060-0003", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0003", "comment_date": "2020-07-28T04:00:00Z", "comment_title": "Comment on CMS-2020-0060-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 86}, {"text": "See attached file.", "comment_id": "CMS-2020-0060-0008", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0008", "comment_date": "2020-07-29T04:00:00Z", "comment_title": "Comment on CMS-2020-0064-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 18}, {"text": "Please see attached. ", "comment_id": "CMS-2020-0060-0004", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0004", "comment_date": "2020-07-29T04:00:00Z", "comment_title": "Comment on CMS-2020-0060-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 21}, {"text": "Please see the attached letter from axialHealthcare.", "comment_id": "CMS-2020-0060-0005", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2020-0060-0005", "comment_date": "2020-07-29T04:00:00Z", "comment_title": "Comment on CMS-2020-0060-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 52}]}, {"id": "DOD-2015-OS-0118", "title": "Privacy Act of 1974; System of Records (alteration, DMDC 02 DoD, Defense Enrollment Eligibility Reporting Systems (DEERS))", "context": "2020-10-22T01:30:01Z", "comments": []}, {"id": "FDA-1994-P-0021", "title": "ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/30mg-CLOSED", "context": "2023-05-02T10:50:35Z", "comments": []}, {"id": "DEA-2013-0010", "title": "Schedules of Controlled Substances: Placement of Tramadol into Schedule IV", "context": "2021-12-02T01:01:29Z", "comments": [{"text": "See attached file(s)", "comment_id": "DEA-2013-0010-0021", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0021", "comment_date": "2014-01-06T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Caroline", "commenter_lname": "Juran", "comment_length": 20}, {"text": "The reason this drug is being prescribed more is because the doctors don't fear the DEA breathing down their neck with a non scheduled prescription. I suffer chronic pain and this drug works for me. I can't imagine it having any abuse potential as you don't get High on it as you would taking the traditional schedule II and III narcotics. It doesn't even compare to pentazocine (Talwin) Sch IV. There is too much regulation of useful drugs in this country. I don't need my doctors scared to prescribe tramadol for me. I have been on it in excess of 7 years. My dose has remained the same for those seven years, 2 50mg tabs tid. It's not like the other narcotics and I've been on them all in the past at one time or another. If people want to try to get high off something they will. Something else will just fill in that gap. There seems to be a never ending story of scheduling drugs to what end. I live in Washington State, legal pot is available to me if I want it. I can't use marijuana as it makes me sick and I don't think it would help anyhow. Tramadol does help though, I do not want to see any scheduling decisions that scare my doctors off from prescribing a perfectly safe, effective, non escalating dose, necessary drug that I need to function . I have AIDS and severe peripheral neuropathy I have been on every drug from hydrocodone, morphine, and fentanyl and more not to mention all the amitrytylines and neurontins that don't work and cause bad side effects such as ticks, metallic taste, etc. This is the first one I have landed on that did not carry any of those drugs problems. All of those in Schedule II and III caused problems and the doses had to be escalated to keep my pain under control not to mention the addiction from them. I have finally found a non scheduled opiod where I don't have to escalate the dose that works for my pain (I've been on it over 7 years). Tramadol needs to remain unscheduled. This is not the first time this has been proposed and it needs to be overturned again. ", "comment_id": "DEA-2013-0010-0012", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0012", "comment_date": "2013-12-02T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Daniel", "commenter_lname": "Anonymous", "comment_length": 2067}, {"text": " “Docket No. DEA-351”
The Drug Enforcement Administration (DEA) proposes to place the substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including tramadol (the term “isomers” includes the optical and geometric isomers) into Schedule IV of the Controlled Substances Act (CSA).
Ok, for the United States of America to meet or help meet the standards of "Our" treaty obligations under The Psychotropic Substances Act of 1978 as amended by the Controlled Substances Act proper regulation of the substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including Tramadol (the term “isomers” includes the optical and geometric isomers) must be placed into Schedule IV of the Controlled Substances Act (CSA) or subjected to certain defined uses only. Current research shows the above named substance aka Tramadol to affect Public Health in the United States; the substance Tramadol has from research caused "Death", "Sickness" along with affecting "Commerce" by not being regulated enough to prevent "Serotonin syndrome" along with other symptoms.
I find it troubling that proper action has not already reflected a change in the regulation of "Tramadol", however now is the time. So the question proposed is to place "Tramadol" into either Schedule IV or III of the CSA. If "Tramadol" was to be placed into Schedule III of the CSA then what could occur is non use of the substance, now since there are reports of the drug working for some for "Restless leg syndrome" placement into Schedule IV should be considered. Further it would also be unethical not to a placement into the CSA. This substance is nothing compared to substances listed in Schedule III of the CSA so I believe action to place the substance into Schedule IV or V is warranted. I must note that there are similar substances that can be used that are much safer than "Tramadol" and those other substances have listings in Schedule IV and Schedules III along with Schedule II of the CSA.
Tramadol and its similar substances of this listings remind myself of "Libby Zion". I believe that to prevent "Death" along with "illness" caused by "Tramadol" we must accept previous similar occurrences and only allow combinations of Tramadol so in effect Schedule III placement could occur. Further notation should be noted that "Death" and "Illnesses" from using Tramadol are very different than substances listed in Schedule III of the CSA. We cannot compare Tramadol to Hydrocodone. Hydrocodone is an Opioid and Tramadol is Psychotropic in nature and very similar if not the same as a SNRI.
Codification
Section was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Controlled Substances Act which comprises this subchapter.
Change of Name
“Secretary of Health and Human Services” substituted for “Secretary of Health, Education, and Welfare” in par. (3) pursuant to section 509(b) ofPub. L. 96–88, which is classified to section 3508 (b) of Title 20, Education.
Effective Date
Section 112 of title I of Pub. L. 95–633provided that: “This title [enacting this section and section 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title and section 242a of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 801 and 812 of this title] and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States.” [The Convention entered into force in respect to the United States on July 15, 1980.]
", "comment_id": "DEA-2013-0010-0020", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0020", "comment_date": "2013-12-12T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Thomas", "commenter_lname": "Thompson", "comment_length": 4155}, {"text": "Please find attached comments by the Healthcare Distribution Management Association (HDMA). ", "comment_id": "DEA-2013-0010-0028", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0028", "comment_date": "2014-01-06T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Anita", "commenter_lname": "Ducca", "comment_length": 92}, {"text": "Please see the attached document submitted on behalf of the American Veterinary Medical Association.
Thank you!", "comment_id": "DEA-2013-0010-0027", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0027", "comment_date": "2014-01-06T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "W. Ron", "commenter_lname": "DeHaven", "comment_length": 121}, {"text": "Speaking and acting within ALL, ALL INCLUSIVE, his capacities, ALL INCLUSIVE, INCLUDING AND ESPECIALLY as the respective SOLE, PRO BONO Estate Administrator (abbreviated as "SOLE Est. Adm.") of the Delois Albert Brassell Estate (D-U-N-S Number 831823948 and active CAGE Code 5PAZ8) AND Robert James Brassell Estate (D-U-N-S Number 962019514 and active CAGE Code 64WJ9), ALL INCLUSIVE: I WANT MY OFFICIAL, FULLY-UPDATED, FULLY-AUTHENTICATED, FULLY-AUTHORIZED, FULLY-EMPOWERED ET AL., ALL INCLUSIVE, U.S. ET AL., ALL INCLUSIVE, DOD, USCG, NOAA (i.e., National Oceanic and Atmospheric Administration), CIA (i.e., United States Central Intelligence Agency), USDOJ (i.e., United States Department of Justice), HHS (i.e., United States Department of Health and Human Services), ODNI (i.e., Office of the United States Director of National Intelligence) ET AL., ALL INCLUSIVE, COMMON ACCESS CARDS (respectively one set for the aforementioned Delois Albert Brassell Estate and the other set for the aforementioned Robert James Brassell Estate, for now, for more sets WILL BE TIMELY AND CORRECTLY forthcoming) NOW, INCLUSIVE. Ever since I acquired the respective EINs (between Winter 2002 and Winter/Spring 2004) for the respective Delois Albert Brassell Estate (D-U-N-S Number 831823948 and active CAGE Code 5PAZ8) and Robert James Brassell Estate (D-U-N-S Number 962019514 and active CAGE Code 64WJ9), INCLUSIVE, among many various other Estates, INCLUSIVE, I was LEGALLY REQUIRED AND ENTITLED to be FORMALLY, CORRECTLY, TIMELY AND OTHERWISE ON-THE-RECORD informed of the precursors to ALL, ALL INCLUSIVE, such all-in-one smart cards, INCLUSIVE, so as to continue the work et al., ALL INCLUSIVE, said respective decedents were conducting, had established et al., ALL INCLUSIVE, among many various other affirmative-to-and-for-me matters, concerns et al., ALL INCLUSIVE. These, ALONG WITH MANY VARIOUS OTHER MATTERS, CONCERNS ET AL., ALL INCLUSIVE, WERE NOT FORTHCOMING, INCLUSIVE, i.e., IT DID NOT OCCUR, ALL INCLUSIVE. Said all-in-one smart cards, i.e., Common Access Cards, were, upon my additionally and correctly acquiring the respective New York State Surrogate Court (Suffolk County)-issued Certificates of Letters of Administration (a/k/a Certificates of Appointment) respectively for said Delois Albert Brassell Estate (Court Index Number 176A2004 (original court certificate number 17268), respective Certificate of Letters of Administration granted on and permanently valid from (i.e., respective date of estate administration appointment on) Friday, March 26, 2004 onward) and said Robert James Brassell Estate (Court Index Number 177A2004 (original court certificate number 17269), respective Certificate of Letters of Administration granted on and permanently valid from (i.e., respective date of estate administration appointment on) Thursday, March 18, 2004 onward), acquiring the respective D-U-N-S Numbers for each said and respective Estate AND FINALLY THE RESPECTIVE AND LONG-OVERDUE CAGE CODES (said Delois Albert Brassell Estate's respective CAGE Code actively issued on Tuesday, September 8, 2009 and said Robert James Brassell Estate's respective CAGE Code actively issued on Tuesday, September 10, 2010), ALL INCLUSIVE, REQUIRED TO BE TIMELY, OFFICIALLY, CORRECTLY, ON-THE-RECORD ET AL., ALL INCLUSIVE, TURNED OVER TO ME FIRST AND FOREMOST AS THE SOLE EST. ADM. OF THE RESPECTIVE REGISTERED ENTITIES SAID ESTATES, ALL INCLUSIVE. SAID COMMON ACCESS CARDS AND THEIR RESPECTIVE PRIVILEGES ET AL., ALL INCLUSIVE, WERE ILLEGALLY AND WITHOUT ANY OFFICIAL NOTICE-MAILED-TO-ME-AT-MY-OFFICIAL-BUSINESS-MAILING-ADDRESS-AT-THE-UNITED-STATES-POSTAL-SERVICE-JAMES-A.-FARLEY-BUILDING WITHHELD FROM ME WITHOUT ANY CAUSE ET AL., ALL INCLUSIVE, FROM THE HIGHEST LEVELS, ESPECIALLY FROM WITHOUT DOD, CIA, NOAA AND THE REST OF USDOC (i.e., United States Department of Commerce), USCG AND THE REST OF USDHS, ODNI ET AL., ALL INCLUSIVE, resulting in me, among numerous various other actions, INCLUSIVE, manually (via the USPS First-Class Mail) using my authority to purge virtually all independent contractors and subcontractors (including Charles Ellis Schumer (New York State Office of Court Administration currently-registered Attorney Registration Number 1923804 (since 1976) and William Gerard Asher (New York State Office of Court Administration currently-registered Attorney Registration Number 1209329 (since 1966))) associated with and within said respective Estates except for several respective independent contractors and subcontractors. The purge is OVERDUE AND NECESSARY, ALL INCLUSIVE, despite the metaphorical ET AL., ALL INCLUSIVE, foot dragging ET AL., ALL INCLUSIVE, from the President (i.e., POTUS), the rest of the White House Office/EOP, the United States National Security Council ("U.S. NSC"), the United States Homeland Security Council ("U.S. HSC") ET AL., ALL INCLUSIVE. I WANT ALL, ALL INCLUSIVE, MY COMMON ACCESS CARDS NOW, ALL INCLUSIVE. Thank you.", "comment_id": "DEA-2013-0010-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0007", "comment_date": "2013-11-22T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Robert", "commenter_lname": "Brassell Jr (C07673494)", "comment_length": 5012}, {"text": "On behalf of the Prescription Drug Abuse Medical Task force of San Diego, California we would like to strongly support
the proposed Docket No. DEA regulation 351 to move Tramadol to a schedule IV medication.
Tramadol is currently a "loop hole" drug which is addictive, abused, and diverted, yet many patient and prescriber do not realize this because it is not a controlled substance. Tramadol cannot currently be tracked in our state Prescription Drug Monitoring Program because it is not a scheduled medication.The morphine equivalents of the typical Tramadol dose of 50 mg contains 10 morphine equivalents compared to Hydrocodone 5mg which contains 5 Morphine equivalents and Oxycodone 5 mg which contain 7.5 morphine equivalents.
This regulation is an important step in combating the prescription drug abuse epidemic.
Roneet Lev, MD FACEP
Chair, Prescription Drug Abuse Medical Task Force
San Diego, California", "comment_id": "DEA-2013-0010-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0006", "comment_date": "2013-11-18T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Roneet", "commenter_lname": "Lev", "comment_length": 965}, {"text": "Society might not be as inept as believed to be
by those in power. Leave the people alone.
Let us decide what we ingest for pain or anxiety.
Many of us elderly persons know by now
That too many doctors turn away From pain treatment even though we
Patients have read about our "right to pain relief".
IGNORE THE STIGMA
SOMEONE HAS BEEN CRYING AND WRITHING AT
HOME, BED-RIDDEN FOR 3 WEEKS... RECLUSE..
IN PAIN.. TRULY WISHING FOR DEATH, when
Just a block away, medicine sits guarded by our laws..
Nurses and pharmacy assistants laugh us off
And the whole of society sits judging without pity
Or empathy. Control, control, and kill. Just wait until it
Happens to your loved one. It's coming for you, and you are
Not fighting hard enough for our liberty.
Stop badgering Doctors. They want to help, but dare they?
BUT THE DOCTOR SAYS I'M FINE
FINE? I'D BE BETTER OFF DEAD.
It's disgusting to witness someone hopeless, in pain ", "comment_id": "DEA-2013-0010-0024", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0024", "comment_date": "2014-01-06T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Deborah", "commenter_lname": "Anonymous", "comment_length": 1084}, {"text": "My girlfriend was in horrible pain for along time barely able to get off the couch. She had surgery her stomach muscle was torn from hip bone. Ins paid for half. Now both sides are torn and she has no insurance, being able to take the tramadol does not take all of her pain away but it helps to lead a some what normal life. It brakes my heart to think of her going back to that miserable women on the couch. Before the injury she was a work horse even worked side by side with her husband to build their own house. I realize there are addicts that abuse things but they always find some thing to get high on, Robatussin spray paint cans or whatever sick thing they find. The people that really need it and don't abuse it are the ones that will suffer. There not going to stop selling Robatussen or spray paint are they?", "comment_id": "DEA-2013-0010-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0010", "comment_date": "2013-11-26T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 827}, {"text": "I support the proposed Docket No. DEA-351, Schedules of Controlled Substances: Placement of Tramadol into Schedule IV. As a Certified Pharmacy Technician I see on a daily basis the abuse that Tramadol gets from patients. It is a controlled substance in Mississippi and the stricter laws have seemed to lessen the abuse. Since it is a controlled substance in this state, patients are only allowed to get this prescription at the max, two days early and a max of five refills per prescription.
Mississippi is one of the more stricter states when it comes to controlled substances and medications in general. We are one of two states that has made pseudoephedrine a scheduled drug and we are also a state in which controlled medications cannot be transferred, even within the same state or even to the same chain pharmacy. Tramadol’s opioid like actions makes it just as addicting as other opioid’s. The known abuse of its pharmacology is a potential harm to patients and society. Since becoming a controlled substance in Mississippi it has cut down on many issues that comes with dispensing addictive but non-controlled medications. Instead of just refusing to fill it we can now go back to the state laws and their regulations regarding controlled substances. This proposed docket would also make the penalties for illegal manufacturing, dispensing, distribution, export, import or any other illegal activity harsher in punishment.
", "comment_id": "DEA-2013-0010-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2013-0010-0008", "comment_date": "2013-11-25T05:00:00Z", "comment_title": "Comment on FR Doc # 2013-25933", "commenter_fname": "M", "commenter_lname": "Williams", "comment_length": 1504}]}, {"id": "FDA-2005-N-0093", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine; Khat; Tramadol; Zopiclone; Buprenorphine; Oripavine ", "context": "2021-09-01T01:01:14Z", "comments": [{"text": null, "comment_id": "FDA-2005-N-0093-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0007", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0004", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0010", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0005", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0003", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0011", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0006", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0009", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0008", "comment_date": "2006-01-24T05:00:00Z", "comment_title": "Food and Drug Administration - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}, {"text": null, "comment_id": "FDA-2005-N-0093-0002", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-N-0093-0002", "comment_date": "2005-12-19T05:00:00Z", "comment_title": "'Ray of Light Cannabis Chrisitan Ministry ' - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 0}]}, {"id": "SAMHSA-2016-0004", "title": "Protecting Our Infants Act Report to Congress ", "context": "2021-05-04T01:00:35Z", "comments": [{"text": "See attached file(s)", "comment_id": "SAMHSA-2016-0004-0023", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0023", "comment_date": "2017-02-21T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Rebecca", "commenter_lname": "Abbott", "comment_length": 20}, {"text": "Stop infant circumcision. ", "comment_id": "SAMHSA-2016-0004-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0007", "comment_date": "2017-01-27T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 26}, {"text": "See attached letter from the American Society of Addiction Medicine", "comment_id": "SAMHSA-2016-0004-0016", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0016", "comment_date": "2017-02-17T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Susan", "commenter_lname": "Awad", "comment_length": 67}, {"text": "See attached letter from Alkermes.", "comment_id": "SAMHSA-2016-0004-0018", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0018", "comment_date": "2017-02-21T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Sarah", "commenter_lname": "Akerman", "comment_length": 34}, {"text": "Please see attached comment letter.", "comment_id": "SAMHSA-2016-0004-0020", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0020", "comment_date": "2017-02-21T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Seamus", "commenter_lname": "Dolan", "comment_length": 35}, {"text": "Women need supports in addition to services, while pregnant and after their child is born. Babies exposed to drugs in utero are often fussy, difficult to soothe infants and children. It would be wonderful if the administration could find a way to tap into the compassionate individuals who are Pro-Life to volunteer their services to these families in need. Perhaps hospitals, clinics and treatment programs could be funded to advertise for volunteers and pay for child abuse and other appropriate clearances and provide training to the volunteers. Magee-Womens Hospital in Pittsburgh, PA has a program in their neonatal unit for volunteers to hold and rock babies. The waiting list is so long they no longer take names for volunteers. Programs like this across the country would be wonderful.", "comment_id": "SAMHSA-2016-0004-0009", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0009", "comment_date": "2017-01-31T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Janice", "commenter_lname": "Meinert", "comment_length": 799}, {"text": "See attached file(s)", "comment_id": "SAMHSA-2016-0004-0011", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0011", "comment_date": "2017-02-14T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Victoria", "commenter_lname": "Coleman-Cowger", "comment_length": 20}, {"text": "Please see Drug Policy Alliance's comment on Docket Number SAMSHA 2016-0004 attached.", "comment_id": "SAMHSA-2016-0004-0022", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0022", "comment_date": "2017-02-21T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Grant", "commenter_lname": "Smith", "comment_length": 89}, {"text": "As a former methadone patient who gave birth to 3 children while in treatment, I would like to see national standards advocating the use of split dosing upon confirmation of pregnancy. Maintaining an even level of medication in the system is essential to avoid learned withdrawal response in infants and can reduce symptom severity or prevent neonatal abstinence syndrome. There was no document or public study available concerning pregnancy while in methadone treatment. I had to do the research myself and present the studies to the clinic doctor in order to Split dose for the duration of my pregnancy and while breastfeeding. None of my children experienced NAS due to my diligence and willingness to fight for the healthiest outcome for them. Not all clinics are willing to allow for split dose. In my time as an advocate for patients, there were multiple occasions where despite the research, the clinic refused the patient split dose simply due to inconvenience, which is not a proper response in an evidence-based setting. Setting national standards, giving a clinic the proper method for administering medication during pregnancy, would benefit both mother and child and would reduce the severity of NAS in this population.
Additionally, having a website where patients could easily read the potential complications and outcomes of opioid use in pregnancy is necessary. There is no one place where these women could read the studies, learn the potential for NAS symptoms in babies, and educate themselves on the effect of use and ways to lessen the potential for these effects on their children. Knowledge is instrumental in assisting these women.
", "comment_id": "SAMHSA-2016-0004-0010", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0010", "comment_date": "2017-02-06T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Ericka", "commenter_lname": "Lear", "comment_length": 1683}, {"text": "RE: Docket Number SAMHSA-2016-0004
The Association of State and Territorial Health Officials (ASTHO) is pleased to offer the attached comment letter regarding the
Protecting Our Infants Act Report to Congress, "Part 4: Strategy to Protect Our Infants" (Section 2(b) of the Act) to the
Substance Abuse and Mental Health Service Administration (SAMHSA), US Department of Health and Human Services.
", "comment_id": "SAMHSA-2016-0004-0012", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0012", "comment_date": "2017-02-14T05:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Lynn", "commenter_lname": "Chaiken", "comment_length": 435}]}, {"id": "FDA-2004-P-0101", "title": "Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA-CLOSED", "context": "2021-09-01T01:02:11Z", "comments": []}, {"id": "FDA-2003-P-0115", "title": " determine whether Methenex (Methadone Hydrochloride 40 mg,Naloxone Hydrochloirde 2 mg) Tablets (effervescent) NDA 17-491 and NDA 17-490 Methenex (Methadone Hydrochloride 10 Gm, Naloxone Hydrochloride 0.5 Gm sponsored by Bristol Myers, have been withdrawn, discontinued from marketing or withheld from sale for safety or efficacy reasons\r\n", "context": "2021-09-01T01:02:56Z", "comments": []}, {"id": "FDA-2012-P-1028", "title": "Safety Concerns Regarding Buprenorphine for Opioid Dependence-CLOSED", "context": "2013-05-30T08:33:02Z", "comments": [{"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0004", "comment_date": "2012-10-23T04:00:00Z", "comment_title": "Amneal Pharmaceuticals, LLC (Venable LLP) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached file.", "comment_id": "FDA-2012-P-1028-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0007", "comment_date": "2012-12-11T05:00:00Z", "comment_title": "Actavis Inc. - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 25}, {"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0016", "comment_date": "2013-02-26T05:00:00Z", "comment_title": "Morgan Lewis & Bockius - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0015", "comment_date": "2013-02-26T05:00:00Z", "comment_title": "Amneal Pharmaceuticals, LLC (Venable LLP) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Actavis Inc. Comments to Docket No. FDA-2012-P-1028 (1-31-2013)", "comment_id": "FDA-2012-P-1028-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0014", "comment_date": "2013-02-26T05:00:00Z", "comment_title": "Actavis Inc. - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 63}, {"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0003", "comment_date": "2012-10-23T04:00:00Z", "comment_title": "American Society of Addiction Medicine - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0012", "comment_date": "2013-02-26T05:00:00Z", "comment_title": "American Society of Addiction Medicine - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0013", "comment_date": "2013-02-26T05:00:00Z", "comment_title": "American Society of Addiction Medicine - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "This memo is submitted to provide a correction to the Reckitt Benckiser Pharmaceuticals -- Response to Amneal Comment (Doc ID: FDA-2012-P-1028-0005)", "comment_id": "FDA-2012-P-1028-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0006", "comment_date": "2012-12-11T05:00:00Z", "comment_title": "Reckitt Benckiser Pharmaceuticals Inc. - Correction", "commenter_fname": null, "commenter_lname": null, "comment_length": 148}, {"text": "See attached file(s)", "comment_id": "FDA-2012-P-1028-0017", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0017", "comment_date": "2013-02-26T05:00:00Z", "comment_title": "Amneal Pharmaceuticals, LLC (Venable LLP) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}]}, {"id": "FDA-1994-P-0016", "title": "ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/15mg-CLOSED", "context": "2023-05-02T10:39:35Z", "comments": []}, {"id": "DEA-2015-0009", "title": "Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl into Schedule I", "context": "2021-12-02T01:00:50Z", "comments": []}, {"id": "CMS-2022-0191", "title": "Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024", "context": "2023-08-09T10:02:19Z", "comments": [{"text": "I am writing as a concerned Independent Agent, who cares about my clients and the means to which I can help them find the best Medicare Supplement option for their specific needs. Adding more and more regulations to agents AS A WHOLE will only be to the detriment of my clients and potential clients. Independent Agents are not the same categorically, as those at a large call center who are simply badgering Medicare Beneficiaries. They certainly don't care about the individuals they are calling. They just want to convince them to sign up for their product. These are the agencies you need to be regulating. NOT the Independent Agencies who actually HELP their clients. Adding more regulations, such as recording phone calls (2023 regulation) and 48 hour Scope of Appointments (proposed for 2024) will only hinder our ability to help our current clients and potential clients. We actually know our clients in most cases. We knew them when they were our clients for the Marketplace or an employee for one of our group clients. We know their health history and we take the time to go over what medications they take, to be sure they get the best supplements for their specific needs. We will no longer be able to do that with our hands tied! Please take these concerns into consideration for the current and proposed regulations. Please consider separating the regulations imposed on Independent Agencies vs the Large Call Centers who are cold calling beneficiaries without consent. They are the big bad wolf you are looking to tie up, not me!", "comment_id": "CMS-2022-0191-0253", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0253", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": "Sara", "commenter_lname": "Dean", "comment_length": 1550}, {"text": "•Prior authorization policies should only be used to confirm the presence of diagnoses. They should not be used to predetermine the necessary length of stay or for preadmission coding. ", "comment_id": "CMS-2022-0191-0301", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0301", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": "Cindy", "commenter_lname": "Thomas", "comment_length": 230}, {"text": "MTM Eligibility - We oppose lowering the cost threshold to the average annual cost of 5 generic drugs. Decreasing the cost threshold to one fifth of what the 2023 threshold is, will greatly increase the number of MTM eligible members, which again, is a significant financial impact to plans. The increased administrative cost will result in increased member premiums, copays and deductibles and will not result in more robust plan benefits to offer members.
We request some additional clarification and details on the proposed updated annual cost threshold methodology to fully understand the impact of this change. Will the methodology utilize the top 5 utilized generic drugs by prescription volume? Or the top 5 generic drugs by cost (i.e., plan paid amount)? Will this include/exclude generic specialty medications, that may be outliers in terms of cost compared to other non-specialty generic medications? Will there be a process to detect outlier NDC's to ensure they are not included in the average AWP calculation? Is the cost per 30-day supply of medication? ", "comment_id": "CMS-2022-0191-0287", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0287", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 1076}, {"text": "Below is an example of a Medicare Advantage plan clearly stating in the denial rationale that the 2MN rule does not apply to Medicare members. I have also attached a redacted determination letter from a different Medicare Advantage plan and another attachment of my supportive statements for the necessity of CMS-420-1.
Clinical: 75 yo woman presented to the ED with bloody stools and leg swelling. Positive signs of heart failure. Anemia with a hemoglobin of 7.5 and dropped to 6.8 and heme positive stools. Found to have acute diverticulitis and new cardiomyopathy with congestive heart failure; ejection fraction of 30%. Required four night stay for stabilization and treatment of acute diverticulitis, GI bleed and congestive heart failure.
MA plan determination: The member was hospitalized from 04/09/22 to 04/12/22 (discharged 04/13/22) at a DRG facility. Does the admission meet InterQual criteria (Severity of Illness and Intensity of Service) for acute inpatient level of care, OR could the services have been provided in an observation level of care? The two-midnight rule does not apply. InterQual criteria is used for both Commercial and Medicare members.
Determination: Upheld.
The member does not meet defined InterQual criteria for inpatient admission for GI bleed or diverticulitis. The admission dated 04/09/22 to 04/12/22 (discharged 04/13/22) does not meet InterQual criteria (Severity of Illness and Intensity of Service) for acute inpatient level of care. The services could have been provided in an observation level of care.
", "comment_id": "CMS-2022-0191-0295", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0295", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": "Florian", "commenter_lname": "Moger", "comment_length": 1591}, {"text": "We would like clarification on how the adherence measures will be excluded from the CAI adjustment. Our understanding is that the CAI adjustment looks at the total population of the plan and calculates the percentage of low income, dual eligible, and disabled members. It is unclear how excluding the adherence measures would be applied to the calculation. Furthermore, we are concerned with the impact of implementing risk adjustment to the adherence measures. For the diabetes adherence measures, the change had an adverse effect on the rating.", "comment_id": "CMS-2022-0191-0280", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0280", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 546}, {"text": "I support you efforts to make MA plans more closely align their coverage decisions with traditional Medicare. ", "comment_id": "CMS-2022-0191-0327", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0327", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": "RUSSELL", "commenter_lname": "JACKSON", "comment_length": 111}, {"text": "Regarding Guardrails - We feel that removing the guardrails will lead to unpredictability which will hurt plan's ability to budget and plan. While we understand that Tukey is meant to remove outliers and limit large swings, we feel keeping the guardrails in place will act as a guarantee.", "comment_id": "CMS-2022-0191-0282", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0282", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 292}, {"text": "Page 58, Section H. Review of Medical Necessity Decisions by a Physician or Other Health Care Professional With Expertise in the Field of Medicine Appropriate to the Requested Service and Technical Correction to Effectuation Requirements for Standard Payment Reconsiderations (§§ 422.566, 422.590, and 422.629)
•Adverse Decision – appropriate expertise to deny – Is there more objective direction that can be provided to define this as it feels slightly subjective?
", "comment_id": "CMS-2022-0191-0319", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0319", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 547}, {"text": "If you think direct mail during an election year is bad, you should see the volume of mail during Medicare Open Enrollment. Just like a political campaign, it can be difficult at times for knowledgeable professionals to figure out the best health insurance product let alone a single, 85 year-old, childless widow with chronic health conditions. Our hospital, Neosho Memorial, sponsored an unbiased educational program this year using SHICK counselors through the Area Agency on Aging. The attendees stories were desprate and heartbreaking. CMS's policy and technical changes to Medicare Advantage Program is good for our elderly and their healthcare providers. Please continue, you cannot underestimate the difference they will make in helping our patients simply make better choices AND receive the health services they "believe" they are paying for.
", "comment_id": "CMS-2022-0191-0240", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0240", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": "Patricia", "commenter_lname": "Morris", "comment_length": 878}, {"text": "I am an agent and mentor I teach agents how to own their own Medicare business. I read the deceptive marketing practices flourish in Medicare advantage Report by the finance committee. If you really look at the organizations that have the majority of complaints to CMS. You will find it is the robocallers, telemarketing, Television Advertising, radio advertising, and direct mail campaigns. These are the Third party organizations (TPMO), the problem is CMS and Ron Wyden Committee has lumped the above with Field agents and brokers. They are not the same and agents and Agency's do not advertise nor act to deceive consumers.
You need to separate these bad actors from independent agents and Agency's. Independent agents are helping consumers understand Medicare and are local in their area helping consumers understand Medical Group Networks, Formularies, and how the plan works. We do not call without a permission to call or SOA. Independent agents should not be lumped into these bad actors that you talk about in your deceptive marketing report, you know who is to blame yet you are punishing agents and agency owners who are not part of these deceptive practices. Agents and Agency owners follow the rules set forth by CMS. We only help those who we meet in person who request our help. Agents and Agencies would be good with getting rid of TV advertising, radio, direct mail campaigns, telemarketing bait and switch. Please do not get rid of educational Events, permission to call and SOA we are out here helping not hurting our seniors. We want you to get rid of these people who blow up our customers phone promising the unrealistic freebies that don't exist. But please know it is not the independent agent or agencies. Your problem is people who don't even hold a license in the insurance industry the robocallers, telemarketers, TV ads and deceptive direct mail. Stop those and your complaints will end.
Remember agents were the good guys!", "comment_id": "CMS-2022-0191-0248", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2022-0191-0248", "comment_date": "2023-02-13T05:00:00Z", "comment_title": "Comment on CMS-2022-0191-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 1979}]}, {"id": "FDA-1995-P-0100", "title": "ANDA Suitability for Hydrocodone Bitartrate and Acetaminophen (5mg/325mg) Capsule Form-CLOSED", "context": "2021-09-01T18:03:03Z", "comments": []}, {"id": "FDA-2012-P-1180", "title": "Determine That an Abbreviated New Drug Application (ANDA) Oxycodone Hydrochloride Extended-Release Capsules may be \r\nSubmitted and be Considered Bioequivalent to the Reference Listed Drug (RLD) Oxycontin\u00ae (Oxycodone Hydrochloride Controlled-Release) Tablets", "context": "2016-01-12T12:11:00Z", "comments": [{"text": "Please see the attached comment submitted on behalf of Purdue Pharma L.P.", "comment_id": "FDA-2012-P-1180-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2012-P-1180-0005", "comment_date": "2016-01-12T05:00:00Z", "comment_title": "Comment from Purdue Pharma L.P.", "commenter_fname": null, "commenter_lname": null, "comment_length": 73}]}, {"id": "FDA-2002-P-0051", "title": "Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA-CLOSED", "context": "2021-09-01T01:03:00Z", "comments": []}, {"id": "FDA-2012-P-1034", "title": "Determine Whether SUBOXONE\u00ae (Buprenorphine Hydrochloride and Naloxone hydrochloride) Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg\u00b9 Have Been Voluntarily Withdrawn From Sale - CLOSED", "context": "2013-06-10T16:59:23Z", "comments": []}, {"id": "FDA-2009-P-0154", "title": "Citizen Petition Requesting a Safety Review of ANDAs for which Subutex\u00ae or Suboxone\u00ae is the RLD", "context": "2022-01-05T01:03:40Z", "comments": []}, {"id": "FDA-2014-P-2058", "title": "Requests that the FDA make a determination that Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film in a strength of 16mg/4mg is suitable for submission in an ANDA. The designated RLD is Suboxone 12mg/3mg NDA 022410.", "context": "2023-06-13T09:35:11Z", "comments": []}, {"id": "FDA-2005-P-0058", "title": "Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.", "context": "2021-09-01T01:01:13Z", "comments": []}, {"id": "CMS-2021-0167", "title": "Opioid Treatment Program (OTP): CY 2022 Methadone Payment Exception (CMS-1751-IFC)", "context": "2022-06-22T12:14:07Z", "comments": [{"text": "It would be irresponsible of CMS to reduce OTP (Opioid Treatment Program) reimbursement for methadone while the current PHE is exacerbating opioid use disorders in the Medicare population. We need more, not less, support for medication-assisted treatment providers, and reducing reimbursement rates for methadone would likely make this drug less available to those who need it most. This is critical to avoid further opioid-related deaths.
Given the growing crisis, CMS should seek options to make methadone treatment more widely available by authorizing it to be dispensed in a pharmacy setting and/or increasing reimbursement rates to existing treatment providers. Given the abundance of pharmacies in most communities, this would capitalize on the existing pharmacy infrastructure and enable Medicare beneficiaries who are otherwise limited in treatment options to pursue medication-assisted treatment such as methadone.
", "comment_id": "CMS-2021-0167-0008", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0008", "comment_date": "2021-12-10T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 939}, {"text": "With the nation in the grips of both the COVID-19 pandemic and the enduring opioid epidemic, it is critical to ensure continued access to recovery from opioid use disorder (OUD) for Medicare beneficiaries. The proposed rule to freeze payment to Opioid Treatment Programs (OTPs) for methadone in calendar year 2022 at the current calendar year 2021 rate should be implemented to protect access to methadone treatment.
Over 1.2 million individuals over the age of 65 struggled with substance use disorder (SUD) in 2019. However, only 23.6 percent received treatment. The number of older adults seeking treatment for OUD specifically increased nearly 54 percent between 2013-2015, as the opioid epidemic began to accelerate, affecting individuals regardless of age, race, income, and other demographics. More than 200,000 Medicare beneficiaries nationwide have died due to opioid overdoses since 2015. Additionally, SUD is associated with many negative outcomes including health complications, accidents due to impairment, and decreased productivity. Individuals ages 65 and over are especially vulnerable during the pandemic.
According to the National Institute on Drug Abuse (NIDA), the effects of many substances, including opioids, such as impaired judgement or coordination, can lead to falls and motor vehicle accidents, which pose a much greater risk for older adults. Additionally, NIDA research shows that older adults are more likely to suffer from mood disorders, heart conditions, and cognitive disorders, all of which can worsen due to SUD, increasing negative health outcomes.
Though rates of opioid use and overdoses were increasing as the pandemic began, they have surged to new highs, with a 28.5 percent increase over the first 12 months of the pandemic. Older adults are more likely to be isolated due to the pandemic and more likely to have access to prescription opioids. Overdoses among Medicare beneficiaries rose by roughly 200 per month during the second half of 2020, during the heights of the pandemic.
With the rates of overdose and OUD rising among Medicare beneficiaries, it is necessary to ensure continued access to OUD treatment. Medication-assisted treatment (MAT), which combines medications such as methadone and Suboxone with individual and group therapy, has proven to be the most effective treatment for OUD, and therefore it is critical to protect and expand access to MAT, especially as the pandemic continues. Many individuals struggle to find openings in existing MAT programs. Others are in communities without access to MAT at all. A 2019 University of Michigan study identified the biggest barriers to MAT treatment, according to providers, are state regulations and reimbursement rates. Additionally, as the opioid epidemic has spread, public support for prevention and treatment of OUD has significantly increase, decreasing stigma, a significant barrier to treatment.
The addition of methadone treatment as a Medicare Part B benefit in January 2020 expanded access to MAT to a large portion of older adults struggling to find recovery. However, a sharp and dramatic decrease in the reimbursement rate for methadone could upend that progress. As stated above, providers have identified reimbursement rates and costs as one of the top barriers to MAT. Slashing the reimbursement rate for methadone, especially with so little data available, could lead to financial impacts for clinics providing methadone treatment, significant cost sharing for Medicare beneficiaries, and other barriers to treatment at a time when the pandemic is fanning the flames of the opioid epidemic.
It is possible that freezing the rate at the current level will still result in some of these negative outcomes, as supply chain and logistics issues have driven up prices across the country and the globe. It is possible an increase is necessary. However, freezing the rate at the current level is a prudent solution for the moment. As stated in the proposed rule, a year will allow CMS additional time to study methadone use among Medicare beneficiaries, the prevalence of the two available methadone formulations, as well as potential alternative reimbursement formulas, given the unique nature of methadone.
Though it is concerning, given widespread inflation, that the rate will remain static in calendar year 2022, CMS’ rationale for this proposed rule is sound, and allows for additional time to study methadone treatment in general, a new benefit for Medicare. The proposed rule prevents a sharp decrease in the reimbursement rate, which could have injected chaos into the already fragile MAT infrastructure. Upon implementation of the proposed rule, it is critical that CMS dedicate significant time and resources to studying methadone treatment and reimbursement, as well as additional MAT options, particularly as the pandemic and opioid epidemic endure.
", "comment_id": "CMS-2021-0167-0009", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0009", "comment_date": "2021-12-15T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 4978}, {"text": "Please continue to keep current payment rates. We struggle as it is to have enough providers to provide these services. Decreasing would greatly impact them.", "comment_id": "CMS-2021-0167-0004", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0004", "comment_date": "2021-12-01T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 157}, {"text": "See attached file(s)", "comment_id": "CMS-2021-0167-0011", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0011", "comment_date": "2022-01-04T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See Attached", "comment_id": "CMS-2021-0167-0015", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0015", "comment_date": "2022-01-04T05:00:00Z", "comment_title": "AATOD RE Medicare Exception 01032022", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "PCMA appreciates the opportunity to comment on the U.S. Centers for Medicare & Medicaid Services’ interim final rule related to Opioid Treatment Programs: CY 2022 Methadone Payment Exception (interim final rule). ", "comment_id": "CMS-2021-0167-0012", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0012", "comment_date": "2022-01-04T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 224}, {"text": "On behalf of the Medication-Assisted Treatment Leadership Counsel, please accept the attached comments.", "comment_id": "CMS-2021-0167-0014", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0014", "comment_date": "2022-01-04T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 103}, {"text": "This is a very important issue and the action that is being taken is a step in the right direction. Addiction is a ruthless disease and it can happen to anyone.", "comment_id": "CMS-2021-0167-0007", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0007", "comment_date": "2021-12-10T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 160}, {"text": "Thank you for the opportunity to comment. I am a disabled physician. Please maintain or increase rates for reimbursement for treatment of pain and addiction such as with methadone. Lack of access is driving the overdose deaths. Lack of reimbursement and difficulty of practice is driving providers out. ", "comment_id": "CMS-2021-0167-0010", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0010", "comment_date": "2021-12-15T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 307}, {"text": "Eliminating the annual process to review methadone coverage treatment for CY 2022 to avoid implementing a possible decrease in the payment amounts for methadone for Medicare beneficiaries has been welcoming news for many who are indirectly or directly affected. I fully support maintaining the CY 2021 payment rate for methadone to treat opioid use disorders into CY 2022.
While many people might agree simply because it feels like the right thing to do, data across states indicate that this measure is critical for the fight against opioid overdose during the Coronavirus Disease 2019 (COVID-19) pandemic. The Centers for Disease Control and Prevention reported an increase in the use of opioids as the COVID-19 brought about lockdowns and quarantines. Prior to COVID- 19 opioid overdose cases consistently increased, but between May 2019 to May 2020, the United States saw 81,000 overdose deaths, the largest ever recorded.
While some data suggest that steps taken have improved prescription opioid misuse and fatalities, there have been increases with synthetic opioids such as Fentanyl, which is 50 to 100 times more potent than morphine. Prescription opioid misuse among medicare beneficiaries tends to come from chronic pain as they age.
The report states that nearly one million adults age 65 and older live with Substance Use Disorders (SUD). This number is almost certain to have increased over the years, following the increasing trend and the effects of the pandemic. It emphasizes the need to increase OTPs and expand the services offered across all states. Opioid use among older adults can result in excessive sedation, respiratory depression, impairment in vision, attention, coordination, and falls. Currently, falls are the leading cause of injury-related death among adults age 65 and older.
Decreasing the payment rate to Opioid treatment programs from $37.38 to $17.64 would have grave consequences, limiting access to SAMSHA certified and Medicare/Medicaid enrolled Opioid Treatment Programs (OTP). Many programs may choose not to participate due to inadequate funding.
These OTPs also provide psychosocial services. Most of these services have been transitioned to Telemedicine, thereby improving access. Data studying a clinician’s perspective on methadone service delivery indicate that 85 % of OTPs offered Telemedicine for medication management, psychosocial services, or both. These services might not be provided if payment rates are reduced.
Another factor to consider is that a decreased rate may hinder the enthusiasm and motivation of employees at OTPs. Compensation and benefits are directly related to employee motivation. Low employee morale can adversely affect attracting and retaining the best employees and negatively affect productivity.
While this interim final rule (IFC) freezes the payment to OTPs for methadone in CY 2022 at the CY 2021 rate, the annual update to the non-drug component of HCPCS G2067 for CY 2022 as required under § 410.67(d)(4)(iii) will be applied. It is worth noting that the effects of the pandemic on opioid use disorders will be long-lasting, possibly several years.
Much of the data required for evidence-based decision-making has been undermined by poor data collection, tracking, and COVID-19 restrictions. Opioid overdose is a public health crisis requiring increasing public awareness about prescription misuse, overdose, and making safe choices while providing both drug treatments and non-drug therapy.
According to the Centers for Disease Control and Prevention, the U.S. economic cost of opioid use disorder was 471 billion and fatal opioid overdose $550 billion during 2017, a total cost of $1,021 billion
The combined costs varied from $985 million in Wyoming to $1,204 in Hawaii. Federal and state public health agencies can use these data to help guide research, prevention, and resource allocation decisions.
", "comment_id": "CMS-2021-0167-0006", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2021-0167-0006", "comment_date": "2021-12-10T05:00:00Z", "comment_title": "Comment on CMS-2021-0167-0002", "commenter_fname": null, "commenter_lname": null, "comment_length": 3971}]}, {"id": "FDA-2016-N-2648", "title": "Announcement of Requirements and Registration for the 2016 FDA Naloxone App Competition", "context": "2016-09-20T09:36:10Z", "comments": []}, {"id": "DEA-2023-0028", "title": "Expansion of Induction of Buprenorphine via Telemedicine Encounter (DEA948)", "context": "2023-07-27T17:37:58Z", "comments": [{"text": "See attached file(s)", "comment_id": "DEA-2023-0028-2732", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2732", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "DEA-2023-0028-2708", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2708", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "DEA-2023-0028-2727", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2727", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "DEA-2023-0028-2703", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2703", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached file(s)", "comment_id": "DEA-2023-0028-2731", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2731", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": "Caden", "commenter_lname": "Owens", "comment_length": 20}, {"text": "The Blue Cross Blue Shield Association (BCBSA) appreciates the opportunity to respond to the Drug Enforcement Administration’s (DEA) request for comments on its Notice of Proposed Rulemaking (NPRM) on Expansion of Induction of Buprenorphine via Telemedicine Encounter (88 FR 12890).
BCBSA is a national federation of 34 independent, community-based and locally operated Blue Cross and Blue Shield (BCBS) companies (Plans) that collectively provide health care coverage for one in three Americans. For more than 90 years, BCBS Plans have offered quality health care coverage in all markets across America – serving those who purchase coverage on their own as well as those who obtain coverage through an employer, Medicare and Medicaid.
BCBS companies are committed to addressing the opioid crisis and ensuring that everyone impacted by the opioid crisis receives the right care in the right setting and has access to evidenced-based treatment. BCBS companies continue to work with medical professionals, pharmacists, elected leaders and community organizations to reduce improper opioid use and provide resources, clinical expertise and other insights to address the crisis. These efforts are critical to building and maintaining a robust opioid use disorder (OUD) treatment system that ensures widespread access to treatment.
BCBSA continues to encourage wide promotion of medication-assisted treatment (MAT) as the standard of care for OUD, recognizing that the National Institutes of Health have indicated that MAT has the highest probability of providing effective treatment for OUD when prescribed and monitored safely. As the DEA notes, when prescribed and monitored safely, MAT medications are considered effective in treating OUD, and have been found to have no adverse effects on a patient’s mental capacity, physical functioning or employability. Yet, despite the overwhelming evidence of buprenorphine’s effectiveness for treating OUD, it remains highly underutilized. Only 18% of individuals with an OUD receive MAT, and many receive no treatment at all.
One driver of the somewhat limited uptake is the significant shortage of providers prescribing MAT in many communities, particularly in rural and other underserved areas. On top of the workforce issues challenging primary and mental health care, only a limited number of providers are trained in best practices for OUD treatment, including MAT, and are actively treating the condition. This is demonstrated by the reality that as of 2020, 40% of U.S. counties lacked a single provider that could prescribe buprenorphine for OUD in an office setting.
For individuals currently receiving MAT, this treatment is a key component to maintaining recovery and functioning. If they lose access to this treatment and their recovery is compromised, they may be at risk of losing a job or other serious consequences that could heavily impact their lives and their families.
We applaud the removal of the outdated federal rules that prevented health care providers from prescribing buprenorphine (known as the “X-waiver”), as part of the 2023 appropriations package. This change allows additional health care providers to prescribe MAT for OUD, and further expands patient access to OUD treatment. However, this NPRM undermines that progress by increasing barriers to MAT. We urge the DEA to build the work of Congress in supporting more robust access to MAT for patients with OUD. To that end, we have several recommended modifications to the DEA’s proposed rule, detailed in our attached comment letter.
", "comment_id": "DEA-2023-0028-2714", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2714", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": null, "commenter_lname": null, "comment_length": 3660}, {"text": "As a telemedicine OUD provider, I strongly oppose the DEA's proposal to require an in-person visit for buprenorphine prescription. This is a high-barrier imposition in an era when primary care is increasingly hard to find. There is a complete lack of evidence for in-person visits improving patient outcomes or preventing diversion. This rule will do an immense amount of harm for patients who are most vulnerable as those are the patients who are least able to complete this unneeded task. ", "comment_id": "DEA-2023-0028-2693", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2693", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": "J", "commenter_lname": "Craig", "comment_length": 495}, {"text": "Bicycle Health has changed my life. I abused pain pills since I was 16 yrs old due to a dysfunctional home environment. I am now 38 years old with a 6 yr old autistic son. During Covid and due to my sond behavior I couldn't take the stress and emotional pain anymore and had no where to turn. I started taking Norcos again to help me cope, well sooner than later I needed more and more and it was killing my budget. Mind you all of my immediate family has passed away except for my 67 yr old mother who is not equipped to take my son for me. I cried out to God what do I do!??? I don't want to be on pain pills and I have no way to rehab because no one can take my son (he is nonverbal and I'm a single mom) Bicycle Health Team saved my life. I was able to communicate and get help via video and get kind and compassionate help. Please do not enforce a rule or law that would cost so many their lives. ", "comment_id": "DEA-2023-0028-2696", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2696", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": "Rebecca", "commenter_lname": "Devilbiss", "comment_length": 914}, {"text": "With a medication like buprenorphine, access should be limited as little as possible. Because of the unprecedented rise in opioid related overdoses, drug users should have as much access to regulated safer options like buprenorphine at all times. One should not need a prescription to access this medication. Its not unreasonable for distribution to be monitored, however, especially when considering the ultra-potent opioids that currently keep the illicit market afloat, excessive purchasing of buprenorphine might not indicate illicit redistribution; but the necessary regimen for someone with OUD and an unreasonably high tolerance to live unimpaired. One might argue that increasing access to this extent would increase use among individuals who arent dealing with OUD, however, even in the case that someone who hasnt previously used opioids becomes dependent on buprenorphine, it is a far safer alternative to opioids available from the illicit market. That is ignoring the fact that in many areas, opioids are already available over the counter; like loperamide and tianeptine. Opioids are already readily available to people who dont have a prescription (or a reason to have one), thus more ready access to a reasonably potent opioid like buprenorphine would only serve as a means of harm reduction; allowing anybody who wishes to use an opioid for whatever reason, to do so with a safe, reliable product that is produced within legal regulations, it would slow down the production of novel synthetic opioids created to replace holes in the illicit market, due to a lower demand because of safer access. there are far more benefits to having a legal, easily obtainable substance than one that is prohibited. Looking at alcohol, the situation is almost entirely identical. During prohibition, the purchase of alcohol was made more dangerous because users had to participate in an unregulated market, alcohol that was available was often produced under poor/no regulations and often contained harmful substances like methanol which would result in a deadlier product for users. People can drink themselves to death; and will, whether alcohol is legal, or illegal. The same situation exists with a drug like heroin. People have used opioids for thousands of years, and according to statistics, will continue to do so despite prohibition. If heroin is illegal, the product on the market will be tainted and more dangerous; causing more deaths by overdose. If heroin is legal, the dea can regulate the production of the drug and make sure anyone who uses it is doing so in a far safer environment with a far safer product. legalize and regulate drugs. drug prohibition was created with racist intent and kills people. bye", "comment_id": "DEA-2023-0028-2697", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2697", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": "Patrick", "commenter_lname": "Blount", "comment_length": 2725}, {"text": "In reference to Docket No. DEA-948, please do not restrict access to treatment for opioid use disorder. Peoples lives depend on this assistance. Thank you!", "comment_id": "DEA-2023-0028-2701", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2023-0028-2701", "comment_date": "2023-03-31T04:00:00Z", "comment_title": "Comment on FR Doc # 2023-04217", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 155}]}, {"id": "FDA-1986-P-0034", "title": "ACETAMINOPHEN, ASPIRIN & CODEINE PHOSPHATE ANDA SUITABILITY-CLOSED", "context": "2021-09-01T18:01:11Z", "comments": []}, {"id": "FDA-2017-D-2497", "title": "FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids", "context": "2018-01-29T14:06:44Z", "comments": [{"text": "See attached file(s)", "comment_id": "FDA-2017-D-2497-0280", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0280", "comment_date": "2017-07-10T04:00:00Z", "comment_title": "Comment from American Medical Association", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "HiDear Sir and Madom
I am a acupuncturist work in Virginia. acupuncture is works. I help many patient out pain or chronic pain with acupuncture. They wrote the story for me before. I put it in attachment as follow, may help you make the decision
", "comment_id": "FDA-2017-D-2497-0293", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0293", "comment_date": "2017-07-10T04:00:00Z", "comment_title": "Comment from Yan Fan", "commenter_fname": null, "commenter_lname": null, "comment_length": 264}, {"text": "Please see uploaded file with comments", "comment_id": "FDA-2017-D-2497-0445", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0445", "comment_date": "2017-07-11T04:00:00Z", "comment_title": "Comment from Academy of Integrative Pain Management", "commenter_fname": null, "commenter_lname": null, "comment_length": 38}, {"text": "On behalf of the Acupuncture Society of Virginia, please see the attached document with our organization's formal comment on FDA Draft Revisions to the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. ", "comment_id": "FDA-2017-D-2497-0321", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0321", "comment_date": "2017-07-11T04:00:00Z", "comment_title": "Comment from Acupuncture Society of Virginia", "commenter_fname": null, "commenter_lname": null, "comment_length": 237}, {"text": "See attached file(s)", "comment_id": "FDA-2017-D-2497-0525", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0525", "comment_date": "2017-07-12T04:00:00Z", "comment_title": "Comment from American Academy of Pain Medicine", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "A recent clinical trial comparing acupuncture to IV morphine in the Emergency Department* showed acupuncture providing comparable pain relief, with a faster onset time and fewer minor adverse events (4 versus 85). A large meta-analysis** definitively established acupuncture's efficacy over and above placebo for chronic pain -- while also showing that even the sham acupuncture (placebo) procedures used for these trials themselves had a clinical effect size of 0.33, comparable to that of NSAIDS but without their side effects (which kill over 10,000 patients per year in the United States).
Many well-meaning and otherwise expert physicians are simply not aware that acupuncture is a highly effective nonpharmaceutical alternative to opioids for acute as well as chronic pain, with an excellent safety profile.
*Grissa, M. H., Baccouche, H., Boubaker, H., Beltaief, K., Bzeouich, N., Fredj, N., ... & Nouira, S. (2016). Acupuncture vs intravenous morphine in the management of acute pain in the ED. The American journal of emergency medicine, 34(11), 2112-2116.
**Vickers, A. J., Cronin, A. M., Maschino, A. C., Lewith, G., MacPherson, H., Foster, N. E., ... & Acupuncture Trialists' Collaboration. (2012). Acupuncture for chronic pain: individual patient data meta-analysis. Archives of internal medicine, 172(19), 1444-1453.
", "comment_id": "FDA-2017-D-2497-0672", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0672", "comment_date": "2017-07-14T04:00:00Z", "comment_title": "Comment from Claudia Citkovitz", "commenter_fname": null, "commenter_lname": null, "comment_length": 1385}, {"text": "See attached file(s)", "comment_id": "FDA-2017-D-2497-0670", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0670", "comment_date": "2017-07-14T04:00:00Z", "comment_title": "Comment from Lynn Ashcraft", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "To: Food and Drug Administration, DHHS
Re: A Blueprint on Using Acupuncture as Adjunct Therapy to ER/LA Opioid Analgesics for Chronic Pain Management
My name is Casey H. Potetz. I am an acupuncture intern at the World Medicine Institute, in Honolulu, Hawaii. I have completed over 2,500 hours of educational and clinical training in the field of Acupuncture and Chinese Medicine. I am pursuing a Master of Science in Oriental Medicine and am on track to achieve Diplomate of Oriental Medicine status in January of 2018.
I want to thank you for opportunity to present comments regarding the management and support of chronic pain patients. I would also like to recognize the FDA's Risk Evaluation and Mitigation Strategy and it's efforts to combat opioid misuse.
Healthcare providers should be aware of available treatment options that may lead to decreased dependency on opioid medications. I have attached an outline of information on acupuncture therapy. This outline is intended to make acupuncture information available to healthcare providers. I am pleased to share this information and accept any questions or comments regarding this subject.
Regards,
Casey Potetz
CaseyPotetz@gmail.com", "comment_id": "FDA-2017-D-2497-0234", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0234", "comment_date": "2017-06-09T04:00:00Z", "comment_title": "Comment from Casey Potetz", "commenter_fname": null, "commenter_lname": null, "comment_length": 1251}, {"text": "See attached file(s) The FDA must not adopt the VA DoD or CDC guidelines, as there is abundant evidence to suggest that these guidelines are responsible for up to 40% of overdose deaths,which are suicides due to untreated chronic pain according to the Montana state suicide coordinator. Physicians must be educated about the very real, deadly consequences of leaving pain unrelieved, and the role that opioids has to play in alleviating many of these people's pain. ", "comment_id": "FDA-2017-D-2497-0640", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0640", "comment_date": "2017-07-13T04:00:00Z", "comment_title": "Comment from Maxx Lamb", "commenter_fname": null, "commenter_lname": null, "comment_length": 470}, {"text": "The Strengthening the Mid-Atlantic Region for Tomorrow (SMART) 501c4 supports the FDA revisions of the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. Educating both prescribers and patients on the risks of opioid therapy is key to combating the opioid overdose epidemic in the long term. We also suggest that the FDA take further action to impact the epidemic through expanding access to naloxone, by implementing a co-prescribing naloxone requirement to patients who are at risk of overdose as part of the FDA REMS program.
See attached file(s)", "comment_id": "FDA-2017-D-2497-0625", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0625", "comment_date": "2017-07-13T04:00:00Z", "comment_title": "Comment from Strengthening the Mid-Atlantic Region for Tomorrow (SMART)", "commenter_fname": null, "commenter_lname": null, "comment_length": 590}]}, {"id": "FDA-2018-P-3355", "title": "Requests that the FDA recategorize Naloxone 4mg Nasal Spray from Legend (prescription only) to over-the-counter status.", "context": "2022-11-17T14:40:09Z", "comments": [{"text": "See attached file(s)", "comment_id": "FDA-2018-P-3355-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0018", "comment_date": "2019-03-06T05:00:00Z", "comment_title": "Comment from NYC Department of Health & Mental Hygiene", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "As an infectious diseases specialist who was a pioneer in HIV/AIDS research, I have seen first-hand the impact of an epidemic has on affected individuals, their families and loved ones, and on the public health of a community. I am now working at the intersection of infectious diseases and the injection opioid epidemic and on developing harm reduction services in rural West Virginia. West Virginia leads the country in opioid overdose fatalities, with the highest rate per 100,000 by a wide margin. Widespread access to naloxone is key to curbing the overdose fatality rate.
Not only does naloxone meet the medical criteria for OTC designation, but the continued difficulties that both people who inject drugs (as well as their families and friends) encounter in obtaining this life-saving medication-- despite state laws meant to facilitate access-- has been well-documented in published studies, including here in West Virginia which is at the epicenter of this devastating epidemic.
OTC access-- as long as the naloxone is affordable-- will go a long way to solving the problem of getting naloxone into the hands of the people who actually need it, especially in rural areas where 911 help can be a 20-minute ride away. This loss of primarily young lives is a public health emergency, and there is no more important mission in healthcare than saving lives. Readily accessible naloxone is essential to that mission.
", "comment_id": "FDA-2018-P-3355-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0012", "comment_date": "2018-11-28T05:00:00Z", "comment_title": "Comment from Judith Feinberg", "commenter_fname": null, "commenter_lname": null, "comment_length": 1446}, {"text": "Increasing the accessibility and availability of Naloxone will save lives. I was a pharmacy technician at the time condoms were moved from behind the pharmacy counter out to the shelves in the Health and Beauty section of a local Target store, and since I stocked those shelves I saw at first hand the increase in sales of these products. There was no prescription requirement on these products, it was simply removing one step (asking the pharmacist or technician for the product). Eliminating the need to ask for a prescription, present the prescription to the pharmacist, and then be offered counselling on the product will reduce stigma and possible embarrassment; this will lead to more instances of Naloxone in the possession of those that could benefit. The only downsides I can see are whether insurances will continue to pay for this product once it is OTC, and what the cost of the product would be (i.e., above the copay amounts the patient would have paid had the product been filled as a prescription).", "comment_id": "FDA-2018-P-3355-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0015", "comment_date": "2018-11-28T05:00:00Z", "comment_title": "Comment from Rob Reinhardt", "commenter_fname": null, "commenter_lname": null, "comment_length": 1019}, {"text": "There are too many people dying from lack of availability. Also the cost remains too high but should be reduced as an over the counter item.", "comment_id": "FDA-2018-P-3355-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0007", "comment_date": "2018-11-05T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 141}, {"text": "See attached document. ", "comment_id": "FDA-2018-P-3355-0019", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0019", "comment_date": "2019-12-12T05:00:00Z", "comment_title": "Comment from Adapt Pharma Operations Limited", "commenter_fname": null, "commenter_lname": null, "comment_length": 24}, {"text": "An effective health intervention is one which is sound in and of itself and which is well-timed. Making naloxone widely available is sound in itself and it would be desperately well timed.
In the past 3 years I've trained about 200 people to use naloxone. They include frightened parents, stressed counselors, and nurses, lab techs, patients and prescribers. Laypeople readily understand how to use nasal naloxone. I've seen the light go on in someone's eyes because they have one more thing now that could save their child or a client they are meeting in the home. The range of health literacy among these has been great. No one has been mystified by the training. What upsets people is the idea of meeting an overdose without it.
Fentanyl is like a runaway train in the switch yard of the opioid epidemic. It's the steepest graph among the 3 describing opioid overdose death. Because the onset of overdose is so quick our best chance to save lives is to have naloxone widely available in our communities. Making naloxone over the counter is a strong step in that direction. While it does not in itself bring the price down, over the counter status is likely to help by expanding the number of people who would access it. If the projected number of deaths, let alone total number of overdose events, for the next decade is approximately 500,000 (AJPH Oct 2018 Humphreys et al) that is a market, unfortunately.
The risk profile for naloxone is nearly zero. Its benefit immense. It is actually a deterrent to abuse: in order to breath the victim must also suffer withdrawal.
As one of the 70 signers of this petition to FDA to make naloxone over the counter I hope FDA will find that it is sound, compassionate and timely to agree with our request.", "comment_id": "FDA-2018-P-3355-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0009", "comment_date": "2018-11-28T05:00:00Z", "comment_title": "Comment from Sara Smith", "commenter_fname": null, "commenter_lname": null, "comment_length": 1812}, {"text": "I submitted a comment about 10 days ago but have not either seen it posted or gotten a rejection. Is there a better way to submit? Others have asked about how to comment. Thanks!", "comment_id": "FDA-2018-P-3355-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0010", "comment_date": "2018-11-28T05:00:00Z", "comment_title": "Comment from Sara Smith", "commenter_fname": null, "commenter_lname": null, "comment_length": 181}, {"text": "Why should an addict who purchases illegal drugs on the street in order to get high (not for legitimate pain relief) be able to get over the counter help, while mllions of americans with painful medical conditions are forced to suffer because medication that helps them has been forcibly reduced to a level where it does not work, or worse, completely removed? US taxpayers and honest Americans should not be paying the price in pain or tax dollars to fix someone elses medical problem. If people in pain cannot get their medication over the counter (and we do not me nsaids which destroy kidneys, liver, cause blood condition problems), OR by prescription, than there is absolutley no reason why someone with an addiction disorder should be able to get their meds OTC.
Figures Lie and Liars Figure Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard A, Lawhern, NPR 11/16/17
http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.html
The Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17
https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935
The truth about the US opioid crisis prescriptions arent the problem
Marc Lewis is a neuroscientist and author on addiction, The Guardian
https://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptions
CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, J Singer, 3/22/18
https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-high
Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.
Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.
https://www.ncbi.nlm.nih.gov/pubmed/28402482
Message to CDC: Tear Down Your Walls of Silence!, 8/20/18,Richard Lawhern, PhD
https://www.painnewsnetwork.org/stories/2018/8/19/message-to-cdc-tear-down-your-walls-of-silence
CDC: Most Overdoses Involve Illicit Opioids, 8/31/18 Pat Anson
https://www.painnewsnetwork.org/stories/2018/8/31/cdc-most-overdoses-involve-illicit-opioids
One in 10 Suicides Linked to Chronic Pain, 9/12/18, Pat Anson
https://www.painnewsnetwork.org/stories/2018/9/12/one-in-10-suicides-linked-to-chronic-pain
Chronic Pain Among Suicide Decedents, 2003 to 2014: Findings From the National Violent Death Reporting System, Annals of Internal Medicine 9/11/18
http://annals.org/aim/fullarticle/2702061/chronic-pain-among-suicide-decedents-2003-2014-findings-from-national
CDC: 50 Million Americans Have Chronic Pain, 9/13/18, Pat Anson
https://www.painnewsnetwork.org/stories/2018/9/13/cdc-50-million-americans-have-chronic-pain
CDC Prevalence of Chronic Pain and High-Impact Chronic Pain Among AdultsUS, 2016, Weekly / 9/14/18 / 67(36);10011006, MORBIDITY & MORTALITY
https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm
Stop Calling it an Opioid CrisisIts a Heroin and Fentanyl Crisis, JEFFREY SINGER, 1/9/18
https://www.cato.org/blog/stop-calling-it-opioid-crisis-its-heroin-fentanyl-crisis
Diversion of Blame and the Opioid Crisis, 9/4/18, Richard Dobson, MD
https://www.painnewsnetwork.org/stories/2018/9/4/diversion-of-blame-and-the-opioid-crisis
B.C. doctors cant limit opioids or discriminate against pain patients: college
CAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18
https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/
Fentanyl & Heroin Deaths Lead Soaring Overdose Rate, 12/21/17
https://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-meds
Why Untreated Chronic Pain is a Medical Emergency 1/28/18
http://www.pharmaciststeve.com/?p=23988
Untreated Chronic Pain can Kill! 6/20/17 Suzanne Stewart
http://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.html
J Geurin, Staff sgt US Air Force (Honorably Medically Discharged)
Served 1997-2008 https://www.regulations.gov/document?D=FDA-2018-N-1621-1264
Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17
https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227
Response Opioid Policy Steering Committee Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MD
University of Alabama at Birmingham School of Medicine & Yale School of Medicine
https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938&attachmentNumber=1&contentType=pdf
Time: Report: Chronic, Undertreated Pain Affects 116 Million Americans, Maia Szalavitz 6/29/11
http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/
War On Opioids Punishes Desperate Pain Patients, The Peoples Pharmacy
https://www.peoplespharmacy.com/2017/03/13/war-on-opioids-punishes-desperate-pain-patients/comment-page-3/#comments", "comment_id": "FDA-2018-P-3355-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0006", "comment_date": "2018-09-27T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5271}, {"text": "Thank you for receiving our petition. This is a much needed step in the right direction to keeping our community and families safe from accidental overdose.
", "comment_id": "FDA-2018-P-3355-0011", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0011", "comment_date": "2018-11-28T05:00:00Z", "comment_title": "Comment from Kristie Klavinger", "commenter_fname": null, "commenter_lname": null, "comment_length": 162}, {"text": "I am writing to support making naloxone available as an OTC medication.
As a practicing physician it is clear that this increased availability will save many lives and produce minimal harm or risk. ", "comment_id": "FDA-2018-P-3355-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0014", "comment_date": "2018-11-28T05:00:00Z", "comment_title": "Comment from Martin Albert", "commenter_fname": null, "commenter_lname": null, "comment_length": 203}]}, {"id": "FDA-2017-N-2903", "title": "Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments", "context": "2017-09-15T11:56:53Z", "comments": [{"text": "See Attached", "comment_id": "FDA-2017-N-2903-0018", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0018", "comment_date": "2017-09-15T04:00:00Z", "comment_title": "Comment from John Burke", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "1) Nomenclature
To call tamper-resistant opioids Abuse Deterrent Formulations (ADFs) substantially misstates what these technologies can accomplish even if and when they work as intended. The Food and Drug Administration (FDA) is a scientific agency that should subscribe to maintain standards of accuracy, especially when communicating with the public and with stakeholders on issue of such grave importance. Accordingly, the term ADFs should be abandoned in favor of a more accurate terminology.
2) Vaccines & Measurement
As was discussed during the public meeting, the appropriate analogy to draw when discussing the effort to elevate all licit opioid-prescribing is to vaccination, which must prove safe and effective for the recipient, and must also provide a herd immunity or substantial public health benefits in outcomes of interest. In order to judge tamper-resistant technology, two separate scales should be considered.
3) Scale 1
Considering the denominator all prescription pain pill users (adherent patients as well as misusing patients and recreational misuse), the FDA should itself sponsor prospective studies of tamper-resistant technologies based on categories of type (not a particular brand). Particular brands should then be asked to match or outperform those results. Entirely new innovations should be judged against similar products with proven results. Any brand that agrees to place its product in the bucket study should be rewarded, if the technology is proven effective, with increased market penetration. The outcome of interest here is: in this community of users, does the technology thwart attempts to manipulate it without incurring new or exacerbating existing hazards?
4) Scale 2
The denominators of interest here are all adverse outcomes: overdose death totals; overdose totals; Hep C or HIV infection rates; etc. The buckets of technology-types and/or individual brands supply the numerator. If these technologies successfully deter manipulation but do not meaningfully affect outcomes vital to abatement of the opioid crisis, then there is a limit to the kinds of "vaccination" or public health claims that can be made on their behalf. On the other hand, if they can be shown as effective, it is important to seize on that knowledge and advance their market penetration.
Kathleen J. Frydl", "comment_id": "FDA-2017-N-2903-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0004", "comment_date": "2017-07-13T04:00:00Z", "comment_title": "Comment from Kathleen Frydl", "commenter_fname": null, "commenter_lname": null, "comment_length": 2383}, {"text": "Inflexxion, Inc. - Comments re: Data and Methods for Evaluating the Impact of Abuse-Deterrent Opioid Formulations", "comment_id": "FDA-2017-N-2903-0014", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0014", "comment_date": "2017-09-12T04:00:00Z", "comment_title": "Comment from Inflexxion, Inc.", "commenter_fname": null, "commenter_lname": null, "comment_length": 113}, {"text": "On behalf of McKesson, I am pleased to submit comments on FDA's notice, "Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments."", "comment_id": "FDA-2017-N-2903-0013", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0013", "comment_date": "2017-09-12T04:00:00Z", "comment_title": "Comment from McKesson", "commenter_fname": null, "commenter_lname": null, "comment_length": 333}, {"text": "See attached file(s)", "comment_id": "FDA-2017-N-2903-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0010", "comment_date": "2017-09-12T04:00:00Z", "comment_title": "Comment from Jack Henningfield", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "We must not leave any room for inference or interpretation with the choice of nomenclature and the words "abuse deterrent" in the context of opioids. Read the attached document to obtain a thorough understanding and rationale for modifying the current language for these formulations.", "comment_id": "FDA-2017-N-2903-0012", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0012", "comment_date": "2017-09-12T04:00:00Z", "comment_title": "Comment from Melissa Tasse", "commenter_fname": null, "commenter_lname": null, "comment_length": 295}, {"text": "Preventing Prescription Opioid Addiction Reduces Reliance on Abuse Deterrent Formulations while Treating Chronic Pain
While the focus of this initiative is to evaluate opioid formulations that are identified as abuse deterrent, the fact is that the recreational abuse of opioids is proceeded by addiction to the opioids. It is just common sense: As with most diseases, preventing opioid addiction is a lot better than needing to treat it or, for that matter, trying to avoid ways those addicted can administer it to achieve a greater high .
In May, Dr. Scott Gottlieb, the new FDA Commissioner, declared that addressing the opioid epidemic is his first and highest priority. In his FDA VOICE blog, he cites data unequivocally establishing prescription opioids as the major cause of opioid addiction. These medications are also gateway drugs: Some 75 percent of heroin users in treatment began their addiction with prescription opioids.
Prescription opioids are responsible for the majority of opioid-overdose deaths, responsible for about 22,000 of the 33,091 fatalities in 2015. The Agency for Healthcare Research and Quality reported 1.27-million emergency-room visits or inpatient stays for opioid-related issues in 2014 (the most recent year for which data is available).
The public debates over legal and regulatory policies to combat this epidemic are ongoing, with opinions continuing to evolve. Yet discussions mainly fail to consider another vital concern: the medically legitimate needs of people who require prescription opioids to help live with chronic pain. The inconvenient truth is that moderate-to-severe chronic pain typically cannot be adequately controlled with non-opioids.
One highly promising solution to this dilemma focuses on an underutilized treatment for chronic pain called buprenorphine ("bu-pren-or-fin"). It is the only opioid in the CIII schedule of drugs, a category recognized by the FDA as representing a reduced risk of addiction. All other opioids for pain are grouped in the riskier CII class.
Until recently, buprenorphine was only available as a once-a-week transdermal (skin) patch, which limited its efficacy and caused some doctors to eschew it. Early last year, however, the FDA approved a twice-daily formulation of buprenorphine that provides significant pain relief: a small, transparent film resembling a Listerine breath strip that dissolves against the inside of the cheek.
In this new form, buprenorphine may play a key role in fighting the prescription-opioid epidemic. It is the least addicting of all the opioids. It typically does not lead to withdrawal symptoms when stopped. Importantly, it reduces the risk of death due to overdose because it doesn't shut down respiration the way other opioids can.
Buprenorphine is not immune to abuse, especially by people who've never before taken prescription-opioid medicationthe so-called opioid-nave. But it poses much less risk than CII opioids because it doesn't produce the same kind of potentially addictive euphoria. People living with chronic pain can get relief from buprenorphine but addicts looking for a high don't like the drug very much, according to studies.
The FDA has approved high-dose buprenorphine (generally, over ten times the amount approved for pain management) as a treatment for opioid addiction. The advantage of buprenorphine is that it can eliminate withdrawal symptoms without triggering euphoria. This is in stark contrast to the use of methadone to treat heroin addiction. The dual ability of buprenorphine to both manage pain and also addiction underscores its uniqueness.
The danger posed by CII opioids is real and immediate. In an analysis by the Centers for Disease Control and Prevention, the longer the exposure of opioid-nave patients to CII opioids, the greater the risk of becoming a chronic user. A one-day supply is associated with a 6 percent risk of continuing the opioid for at least a year; a 30-day supply is associated with about a 35-percent risk of becoming a chronic user.
There are common-sense conclusions to be drawn here. For chronic-pain patients who are not getting adequate relief from non-opioids, prescribers should be required to offer buprenorphine as a first-line therapy before resorting to a CII opioid. For patients who have been on a CII-opioid long-term, the mandate should be to gradually replace the medication with buprenorphine.
The quickest and most effective way to encourage this change is for pharmacy benefit-management companies to adopt these requirements nationally. In addition, the FDA should mandate labelling changes for all CII opioids, requiring that prescribers try buprenorphine first as a treatment for chronic pain.
", "comment_id": "FDA-2017-N-2903-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0003", "comment_date": "2017-07-13T04:00:00Z", "comment_title": "Comment from Frank O'Donnell, Jr MD", "commenter_fname": null, "commenter_lname": null, "comment_length": 4856}, {"text": "I look at the reports on how the "opioid epidemic", has got to be stopped and addressed. I am, along with millions of other Americans, are on the other end of opioids.
I am on the end of the chronic pain disease epidemic. As the CDC, DEA and Medicaid and medicare, and numerous other government associates, are blaming Doctors for the over prescribing of medication, NOBODY, is looking at or reading the statistics from chronic pain disease patients. How about not addressing these drugs as dangerous and addictive. Let's look at them as lifesaving and medically necessary for the million of Americans in chronic pain. Chronic pain is a disease. It is now becoming an epidemic.
No other disease medication is scrutinized. Chronic pain is a disease. We as patients are being denied, dismissed and overlooked by our drs due to all the scrutiny associated with treating chronic pain disease. Our doctors are afraid to treat us adequately. We have a disease that medication is readily accessible to us and we are being denied. We pain patients are truly being discriminated against, due to people who use heroin, illegal fentanyl, and placed a blame on anyone but themselves. This is a witch hunt for drs who prescribe life saving medication and pain disease patients who benefit from this medication.
We have a chronic disease. We want to be able to take care of our homes, our children, our selves, as much as possible, but without access to our, potentially, life saving medications, we are unable to do so. We want to live not just exist in pain 24/7.
We need the government agencies to look at the real statistics, not the hand picked.
We need help. With all the headlines, topics and stories on how opioids are bad, let's look at what good they do for our disease of chronic pain and the million of Americans they help.
", "comment_id": "FDA-2017-N-2903-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0006", "comment_date": "2017-08-07T04:00:00Z", "comment_title": "Comment from Candi Simonis", "commenter_fname": null, "commenter_lname": null, "comment_length": 1901}, {"text": "See attached file(s)", "comment_id": "FDA-2017-N-2903-0009", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0009", "comment_date": "2017-09-12T04:00:00Z", "comment_title": "Comment from Sid Schnoll", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Comments provided by RADARS System", "comment_id": "FDA-2017-N-2903-0015", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0015", "comment_date": "2017-09-12T04:00:00Z", "comment_title": "Comment from RADARS System", "commenter_fname": null, "commenter_lname": null, "comment_length": 34}]}, {"id": "VA-2017-VHA-0004", "title": "AP94 - Interim Final Rule - Fertility Counseling and Treatment for Certain Veterans and Spouses", "context": "2019-03-07T08:26:27Z", "comments": [{"text": "Given that thousands of veterans suffer from the inability to reproduce naturally after combat or training and could benefit from the IVF treatments, it is important to note that each attempt costs $12,000, not including the medications that can cost up to $5,000, which is a lot for anyone to pay out of pocket. I do feel that for veterans with service-connected disabilities the costs should be handled, ultimately costing the veteran and their spouse nothing. I also agree with the combination of the previous comments from Morgan Rector and Julianna Duncan saying that if it was not a full service-connected injury causing them to be incapable of naturally reproducing, then the cost should be dealt with to an extent, but not fully by The Department of Veterans Affairs. I also think Steven Ham's question over coverage of fertility treatments for veterans with PTSD should be examined within the regulation. ", "comment_id": "VA-2017-VHA-0004-0010", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0010", "comment_date": "2017-03-08T05:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Gomel, Trisha", "commenter_fname": "Trisha", "commenter_lname": "Gomel", "comment_length": 918}, {"text": "I have attended the past few Veterans' Affairs hearings and this issue continuously arose. All references to this topic have been completely positive and there are many wishes to continue the support for FY 18. I am in accordance to these views. I believe veterans held up their promise to serve this country and the least congress can do is make sure they are served to the best of this nations ability. I agree with Trisha Gomel's comment when she stated her feelings in regards to veterans with service-connected disabilities. Their costs should be covered, ultimately costing the veteran and their spouse nothing. I am also in accordance to Steven Ham's question over coverage for veterans with PTSD. I think there should be evaluations for all IVF patients and spouses, as well as further evaluations for those who may be borderline on mental health issues. ", "comment_id": "VA-2017-VHA-0004-0012", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0012", "comment_date": "2017-03-15T04:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Bustos, Alysse", "commenter_fname": "Alysse", "commenter_lname": "Bustos", "comment_length": 875}, {"text": "Given the information and statistics on genitourinary injuries it should be a top priority to add fertility counseling and treatments for certain veterans to the Veteran's Health Care Act. It is unfair for veterans not to have the ability to procreate because of injuries sustained at work. Also this will take stress away from current active duty, because there will no longer be a need to have children as soon as possible. With so much medical advancement for IVF the costs for treatment are no longer as high as they once were. Steven Ham's comments on fertility treatment for individuals with PTSD should also be further looked at. Treatments such as IVF may not be necessary for mental situations but fertility counseling maybe a cheaper solution for these situations. ", "comment_id": "VA-2017-VHA-0004-0015", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0015", "comment_date": "2017-03-21T04:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule -Gullan, Steven", "commenter_fname": "Steven", "commenter_lname": "Gullan", "comment_length": 783}, {"text": "I would like to know why my son Collin Nesbitt had to pay for IVF when he got cancer while he was in the military and lost his ability to have kids do I have to contact President Trump to get this taken care of he should be re embersed for have to pay for this.
John Nesbitt
Father of Collin Nesbitt", "comment_id": "VA-2017-VHA-0004-0004", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0004", "comment_date": "2017-02-14T05:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Nesbitt, John", "commenter_fname": "John", "commenter_lname": "Nesbitt", "comment_length": 307}, {"text": "I believe that The Department of Veteran Affairs should cover all In Vitro Fertilization costs for any veterans that were injured in service which resulted in the inability to naturally reproduce and their spouses. These people were selflessly serving our country and they deserve the opportunity to start a family of their own and build a life for themselves. It is the least we can do for them since they give up so much and risk their lives for the United States. Plus, In Vitro Fertilization can be very expensive and not many people can afford to do such a thing, especially veterans coming out of the service who may not have a concrete career to pay for it. I support this proposal and these new regulations and hope that this proposal is passed and that our veterans are given the choice to start their own family. ", "comment_id": "VA-2017-VHA-0004-0008", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0008", "comment_date": "2017-02-21T05:00:00Z", "comment_title": "Comment on AP94-Interim Final Rule-Duncan, Julianna", "commenter_fname": "Julianna", "commenter_lname": "Duncan", "comment_length": 823}, {"text": "my name is Tobi, am 28.
I have always aspire to be a military personnel since I was little which i later change my mind. this is basically because of an uncle (US Army) that turned impotent after a severe injury during war. he is 54years old and he has no child (contrary to his wish). now he can not afford to pay for IVF likewise his insurance. implementing this rule will not only give hope to these kind of veteran but could also encourage more military aspirants.", "comment_id": "VA-2017-VHA-0004-0011", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0011", "comment_date": "2017-03-09T05:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Olu, Tobi", "commenter_fname": "tobi", "commenter_lname": "olu", "comment_length": 473}, {"text": "See attached file(s)", "comment_id": "VA-2017-VHA-0004-0013", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0013", "comment_date": "2017-03-21T04:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Byers, Michael", "commenter_fname": "Michael", "commenter_lname": "Byers", "comment_length": 20}, {"text": "My husband is service connected for testicular cancer and can no longer have children we recently paid out of pocket 17,000 and when we called champva and went to billing at Local VA hospital no one knew anything about this at all. Luckily my husband spoke infront of the senate committee of veterans affairs about PTSD in Sacramento at the capital building and has some of the senates personal numbers. I think he should call them about this.", "comment_id": "VA-2017-VHA-0004-0005", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0005", "comment_date": "2017-02-14T05:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Nesbitt, Alena", "commenter_fname": "Alena", "commenter_lname": "Nesbitt", "comment_length": 443}, {"text": "Submitted in response to RIN 2900AP94Fertility Counseling and Treatment for Certain Veterans and Spouses
The American Society for Reproductive Medicine appreciates the opportunity to comment on the amendments made by the Department of Veterans Affairs to its regulations allowing fertility counseling and treatment to be made available to certain veterans and their spouses.
ASRM is a multidisciplinary organization of nearly 8,000 professionals dedicated to the advancement of the art, science, and practice of reproductive medicine. Distinguished members of ASRM include obstetricians and gynecologists, urologists, reproductive endocrinologists, embryologists, mental health professionals and others.
Members of this country's armed services, injured in active duty in a way that results in their inability to have children without the use of medical treatment, deserve to receive the treatments they need to build their families regardless of whether they seek this treatment while still serving or after separation from service. Therefore, we are in support of the work the Veterans Administration is doing to develop policy and clinical guidelines, consistent with those of the Department of Defense, for providing fertility care and IVF treatment to our veterans.
With 2.8 to 5% of combat injuries to US troops involving genitourinary trauma and the great majority of the injured under the age of 35, there is a definite need for fertility care for this population. While the VA has been able to provide certain fertility treatments, the agency has until now been prohibited by law from offering in vitro fertilization, preventing it from providing precisely the care needed by some of those who have been most severely injured.
We remain very concerned, however, that the legislation that allows expanded assisted reproductive services, i.e., IVF, through the VA is temporary. The need for IVF among injured veterans and their spouses is not going to disappear when the benefit included in the appropriations bill expires on September 30, 2018. The amendment made to VA regulations operates to bring the fertility treatments provided in the Veterans' medical benefits package into line with the fertility treatments available through the DoD to active duty personnel, which is exactly where they need to be and where they need to stay.
ASRM, working with veterans' organizations and infertility patients' organizations, will continue to advocate for repeal of the ban on VA's provision of IVF and to make IVF a permanent part of the Veterans' medical benefits. We hope to be able to achieve this by the time the amendment expires.
", "comment_id": "VA-2017-VHA-0004-0016", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0016", "comment_date": "2017-03-21T04:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - Nicoll, Eleanor", "commenter_fname": "Eleanor", "commenter_lname": "Nicoll", "comment_length": 2725}, {"text": "I applaud the Department of Veteran Affairs for establishing the amendment to the services that are currently provided to veterans. I am glad to read (and agree) with the various comments in support of the VA offering fertility treatments to veterans suffering from the inability to procreate due to a service related injury. I believe that veterans should be able to obtain various medical care for them to live a healthy and fulfilling life. ", "comment_id": "VA-2017-VHA-0004-0014", "comment_url": "https://api.regulations.gov/v4/comments/VA-2017-VHA-0004-0014", "comment_date": "2017-03-21T04:00:00Z", "comment_title": "Comment on AP94 - Interim Final Rule - H., Kayleigh", "commenter_fname": "Kayleigh", "commenter_lname": "H", "comment_length": 444}]}, {"id": "FDA-2021-P-0036", "title": "Requests that the FDA declare that Tramadol Hydrochloride Tablets, 75 mg (scored), is suitable for submission as an Abbreviated New Drug Application.; CLOSED", "context": "2023-10-10T10:33:51Z", "comments": []}, {"id": "FDA-2004-P-0216", "title": "ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg Per 5mL.-CLOSED", "context": "2021-09-01T01:02:14Z", "comments": []}, {"id": "FDA-2012-P-1251", "title": "Declare That Morphine Sulfate Injection USP, 5 mg/ml, is Suitable for Submission in an Abbreviated New Drug Application (ANDA)", "context": "2021-02-09T14:13:57Z", "comments": []}, {"id": "CDC-2018-0085", "title": "Partnership Opportunity to Identify Products for Fentanyl Exposure in Personal Protective Equipment Information Database", "context": "2019-04-01T10:19:41Z", "comments": [{"text": "For this partnership to be most successful, we need manufacturers who are willing to participate and commit to helping end users find appropriate personal protective products that align with current guidance around fentanyl exposure. The current guidance is unclear, and a small working group of manufactures and stakeholders should convene to provide clarity, especially around dermal protection (gowns and coveralls). The CDC has provided guidance around PPE, however in areas such as respiratory, dermal (gowns and coveralls) and eye/face protection, it is not clear as to which PPE would be most effective related to relevant identified PPE standards. I have heard input from manufactures indicating that there is confusion around risk layering (e.g., multiple layers of risk for each identified user group) and that it would be difficult to translate into a guidance tool. More work needs to be done to simplify the PPE selection and risk identification guidance process. ", "comment_id": "CDC-2018-0085-0012", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0012", "comment_date": "2019-02-27T05:00:00Z", "comment_title": "Comment from Jonathan Bihl", "commenter_fname": "Jonathan", "commenter_lname": "Bihl", "comment_length": 978}, {"text": "W.L. Gore & Associates is interested to participate in this effort. Gore is the manufacturer of CHEMPAK brand PPE laminates which are used in CBRN and Hazmat situations. Laminates and ensembles made from CHEMPAK laminates are certified to all classes of NFPA 1994 as well as NFPA 1999 and NFPA 1992.
It is important to take an ensemble approach to both Fentanyl and Ebola, as laminate performance enough is not sufficient to fully protect the first responder. The NFPA standards listed above provide excellent protection hierarchy based on hazard level. This is further discussed in the Interagency Board (IAB) October 2017 Recommended Best Practices to Minimize Emergency Responder Exposures to Synthetic Opioids, Including Fentanyl and Fentanyl Analogs. It is attached for reference. ", "comment_id": "CDC-2018-0085-0020", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0020", "comment_date": "2019-03-28T04:00:00Z", "comment_title": "Comment from Jason Horowitz", "commenter_fname": "Jason", "commenter_lname": "Horowitz", "comment_length": 807}, {"text": "Blauer Manufacturing Co. is interested in participating in this partnership opportunity. Blauer is a producer of PPE certified to the NFPA 1994 standard for Classes 3, 3R, and 4. Consistent with the Interagency Board's (IAB) guidance on fentanyl response, our suits are used by drug interdiction teams that target fentanyl production and milling operations.", "comment_id": "CDC-2018-0085-0019", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0019", "comment_date": "2019-03-28T04:00:00Z", "comment_title": "Comment from Tom Ames", "commenter_fname": "Tom", "commenter_lname": "Ames", "comment_length": 363}, {"text": "RPB Safety would be happy to participate from a respiratory protection perspective.", "comment_id": "CDC-2018-0085-0016", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0016", "comment_date": "2019-03-28T04:00:00Z", "comment_title": "Comment from Christopher Hughes", "commenter_fname": "Christopher", "commenter_lname": "Hughes", "comment_length": 83}, {"text": "Modeling of a reference should be similar to that for hazardous drugs and PPE with regards to testing standards for gloves, gowns and respiratory protection; which to date we have no registry for PPE for hazardous drugs. Noted standards for hazardous drug related PPE:
-ASTM D6978 permeation standard used for gloves for the safe handling of hazardous drugs
-ASTM F739 for materials use for garb while handling hazardous drugs (understanding a new standard is soon to be released)
A document should be created to assimilate the NIOSH Alert "Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings" DHHS (NIOSH) Publication Number 2004165
Understanding the spectrum of the document will go beyond 'Health Care Settings'; it MUST include healthcare in all settings (clinics, hospitals, home infusion, home care settings, etc.)
Scope should include: manufacturing, transportation, receiving, storage, compounding, administration, disposal, investigation, detection, laboratory assessment, patient/victim handling, ultimate destruction
The PPE document should include a simplistic pictographic on the proper donning and doffing sequence to protect individuals.
Example: CDC Ebola PPE posters, attached.
", "comment_id": "CDC-2018-0085-0014", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0014", "comment_date": "2019-03-26T04:00:00Z", "comment_title": "Comment from Fred Massoomi", "commenter_fname": "Fred", "commenter_lname": "Massoomi", "comment_length": 1333}, {"text": "CDC-2018-0085; NIOSH-319
SAS Safety Corp. is willing to participate", "comment_id": "CDC-2018-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0002", "comment_date": "2018-10-19T04:00:00Z", "comment_title": "Comment from Todd Zuella", "commenter_fname": "Todd", "commenter_lname": "Zuella", "comment_length": 76}, {"text": "Hello,
I am submitting on behalf of Draeger as we would like to participate.
Regards,
Jimmy Vo", "comment_id": "CDC-2018-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0004", "comment_date": "2018-11-09T05:00:00Z", "comment_title": "Comment from Jimmy Vo", "commenter_fname": "Jimmy", "commenter_lname": "Vo", "comment_length": 121}, {"text": "3M Personal Safety Division would like to participate.", "comment_id": "CDC-2018-0085-0021", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0021", "comment_date": "2019-04-01T04:00:00Z", "comment_title": "Comment from Donald Rust", "commenter_fname": "Donald", "commenter_lname": "Rust", "comment_length": 54}, {"text": "CDC-2018-0085; NIOSH-319 National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention
Bolle Safety is willing to participate in this program for PPE for Fentanyl Exposure. ", "comment_id": "CDC-2018-0085-0005", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0005", "comment_date": "2018-11-14T05:00:00Z", "comment_title": "Comment from Bill Godfrey", "commenter_fname": "Bill", "commenter_lname": "Godfrey", "comment_length": 224}, {"text": "this certainly brings about corruption. if fentanyl is that dangerous, why is it allowed to be used in america. why isnt it simply banned. i think this invites corruption when govt allows private industry to make money off references set for those using fentanyl.
better to just ban this pollution toxic chemicals from any use at any time in america. this is an invitation to corruption.
shut it down.", "comment_id": "CDC-2018-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/CDC-2018-0085-0003", "comment_date": "2018-10-19T04:00:00Z", "comment_title": "Comment from Jean Ublieee", "commenter_fname": "jean", "commenter_lname": "ublieee", "comment_length": 415}]}, {"id": "FDA-1995-P-0018", "title": "ANDA Suit for Hydrocodone Bitartrate & Acetaminophen-CLOSED", "context": "2021-09-01T18:02:50Z", "comments": []}, {"id": "FDA-2007-E-0400", "title": "Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 5,697,896", "context": "2022-01-05T01:01:15Z", "comments": []}, {"id": "FDA-2012-N-0563", "title": "Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates", "context": "2012-07-13T10:28:32Z", "comments": []}, {"id": "FDA-1993-P-0041", "title": "Butalbital, Acetaminophen, Caffeine & Hydrocodone-CLOSED", "context": "2021-09-01T18:00:26Z", "comments": []}, {"id": "FDA-1982-N-0046", "title": "Revoke Exemption for Prescription Drugs for Cough Cold Symptoms", "context": "2021-09-01T18:01:13Z", "comments": []}, {"id": "DOD-2015-HA-0062", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\nTRICARE: Refills of Maintenance Medications Through Military Treatment Facility Pharmacies or Nation Mail Order Pharmacy Program", "context": "2020-10-22T01:30:45Z", "comments": [{"text": "Attached are the comment of the National Association of Chain Drug Stores", "comment_id": "DOD-2015-HA-0062-0006", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0006", "comment_date": "2015-10-07T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 73}, {"text": "Attached please find comments submitted by the National Community Pharmacists Association (NCPA). ", "comment_id": "DOD-2015-HA-0062-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0007", "comment_date": "2015-10-07T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 99}, {"text": "These people who have worked so hard to ensure our freedom should not have to worry about their medications. This rule is intended to save a few bucks but at what expense? If our retired military are on maintenance medications they can't afford to miss a day of medications due to any sort of delays ie. snail mail. ", "comment_id": "DOD-2015-HA-0062-0008", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0008", "comment_date": "2015-10-07T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 323}, {"text": "Recommend adding the following paragraph under paragraph 5 of Part 199.21 as sub paragraph viii. "All medications not provably known to be chemically stable at temperatures above 150 degrees Fahrenheit will be shipped in climate controlled containers during the months of May through September. All medications not provably known to be chemically stable below the freezing point of water will be shipped in climate controlled containers during the months of November through March. Climate control for these medications will be maintained until in the hands of the customer."
The FDA only certifies medications to be chemically stable between the temperatures of 59 degrees Fahrenheit and 86 degrees Fahrenheit. While some pharmaceutical manufacturers have tested their medications and found the climate control is absolutely necessary, many others have not. UPS trucks and other delivery vehicles in the Southeast U.S. often have on-truck temperatures near the brown sides of their trucks that exceed the boiling point of water. In the winter, particularly in the North, temperatures well below zero are similarly found in these vehicles. Medications exposed to these temperatures can change chemical composition and pose grave risk to the consumer, to include the risk of death. Anecdotal information on mail order pharmacy use in central Alabama has resulted in emergency room visits having been required for some patients as a result of these chemical changes in the heat of summer. The FDA has the necessary reports on file. If mail-order pharmacy use is to be directed, precautions should be taken to ensure the medicines shipped in this matter are kept in proper storage from the door of Express Scripts to the door of the customer.
Those who have served our military and receive these benefits deserve to know their medications are safe. Safeguards should be in place to ensure that all medications are kept within or near the FDA recommended temperature range of 59-86 degrees, unless it is absolutely proven that a particular medication can withstand a greater temperature range. "Best Commercial Practices" do not do this. "Best Commercial Practices" maximize profits, not safety. Those who have served this country deserve to have their safety put first.
As such, I recommend that the proposed insertion of a sub-paragraph viii (8) with the verbiage above, be inserted into the proposed change to the regulations.
", "comment_id": "DOD-2015-HA-0062-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0002", "comment_date": "2015-08-18T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2505}, {"text": "I have concerns that this change while offering some savings to Tricare is only targeting retirees. why aren't active duty being targeted as well? This question has to be asked. Just as there is discussion of hardship waivers, why not blanket waivers for say remote duty stations that have no or limited pharmacy access. Active duty has more readily access the the military pharmacies than most retirees as a good portion of active duty reside on the same military installations the pharmacies. Also will additional staffing be provided at the military pharmacies to accommodate the influx of retirees who will be forced to use the base pharmacy because of this rule? i don't see anything posted about this issue.", "comment_id": "DOD-2015-HA-0062-0005", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0005", "comment_date": "2015-10-05T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 721}, {"text": "I have concerns that this change while offering some savings to Tricare is only targeting retirees. The question has to be asked why aren't active duty being targeted as well? Just as there is discussion of hardship waivers, why not blanket waivers for say remote duty stations that have no or limited pharmacy access. Active duty has more readily access the the military pharmacies than most retirees as a good portion of active duty reside on the same military installations the pharmacies. Also will additional staffing be provided at the military pharmacies to accommodate the influx of retirees who will be forced to use the base pharmacy because of this rule? I see nothing posted about augmenting staffing for the certain influx of retirees.", "comment_id": "DOD-2015-HA-0062-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0003", "comment_date": "2015-08-18T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 752}, {"text": "I would like to make the following comments to the interim final rule revisions paragraph (r) to 32 CFR 199.21:
(2) Medications covered
(iii) It will be cost effective to dispense the medication from the mail order pharmacy.
"A concerted effort on the part of the mail order pharmacy shall be made to refill all prescriptions, for a patient, at the same time. All the filled prescriptions shall be combined and shipped in a single container ". I take 10 prescribed meds by mouth each day; Express Scripts cannot seem to fill all orders at the same time, rather they ship each med on a staggered basis (even when all scripts are submitted at the same time) thereby charging TRICARE more for shipping and handling. My local pharmacy has no trouble filling all the scripts in a single visit for pick up.
(5) Procedures.
(ii) An effective communication plan that includes efforts to educate beneficiaries in order to optimize participation and satisfaction will be implemented.
There must be an administrative channel for feedback as to the service received. My mail order pharmacy issues many conflicting communications to me and there is no one person to talk to. One representative says something that is conflicted by the follow up representative; notification of shipment status is nearly always wrong in that the med does not get shipped as promised and is weeks behind. I do not know that until I call, then I am informed they have not shipped it yet due to some lame excuse. My satisfaction and health therefore suffer. Prior approvals for brand name meds seem to disappear from the system. My doctors spend a great deal of time writing justification of brand name meds and it appears they are routinely denied. Denials of prescription medically necessary medications are not signed by a medical doctor or anyone, there must be personal accountability! Personally, my experience with the mail order pharmacy is that they basically Deceive, Delay, and Deny prescribed meds for military retirees.
", "comment_id": "DOD-2015-HA-0062-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2015-HA-0062-0004", "comment_date": "2015-09-22T04:00:00Z", "comment_title": "Comment on DOD-2015-HA-0062-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2085}]}, {"id": "FDA-2011-P-0869", "title": "Refuse to File Any New Drug Application (NDA) for Buprenorphine/naloxone Drug Product Unless Such NDA References Suboxone\u00ae, the Sublingual Film Formulation of This Product-CLOSED", "context": "2013-11-22T13:02:08Z", "comments": [{"text": "na", "comment_id": "FDA-2011-P-0869-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-P-0869-0007", "comment_date": "2013-11-22T05:00:00Z", "comment_title": "BioDelivery Sciences International, Inc. (Foley & Lardner LLP) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 2}, {"text": "N/A", "comment_id": "FDA-2011-P-0869-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-P-0869-0003", "comment_date": "2012-05-25T04:00:00Z", "comment_title": "BioDelivery Sciences International, Inc. (Foley & Lardner LLP) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 3}]}, {"id": "FDA-2014-P-0752", "title": "Requests That the FDA Issue a Federal Regulation to Place Naloxone Injected or Given Nasally to Reverse an Opioid Overdose Behind the Pharmacy Counter in Addition to Prescription use.", "context": "2015-04-01T07:03:55Z", "comments": []}, {"id": "FDA-2001-P-0416", "title": "Methenex(Methadone Hydrochloride 40mg Naloxone Hydrochloride", "context": "2021-09-01T02:02:39Z", "comments": []}, {"id": "FDA-2018-N-3685", "title": "International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plant and Resin; and 8 additional substances; Request for Comments", "context": "2019-03-04T13:05:41Z", "comments": [{"text": "See Attached", "comment_id": "FDA-2018-N-3685-8235", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-8235", "comment_date": "2018-11-01T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "See Attached", "comment_id": "FDA-2018-N-3685-10664", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-10664", "comment_date": "2018-11-15T05:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "Please rethink your stance on medical cannabis. I truly believe in the healing power of a patients right to choose their medicine and more natural is better. I benefit from medical marijuana in my state of Pa. I have overcome opioid addiction and chronic pain and depression issues. Knowing that no matter what medical problems I have in my future, having access to medical marijuana is enough to help me with my pain and anxiety and depression.
", "comment_id": "FDA-2018-N-3685-4850", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4850", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Meghan Thompson", "commenter_fname": null, "commenter_lname": null, "comment_length": 450}, {"text": "In regards to Cannabis Plant and Resin, I believe that anything less than full legalization is criminal. It makes criminals of decent citizens, and it drives the plant to an unregulated black market. With medical legalization prevalent, with growing consensus worldwide that the war on drugs is causing more harm than good, and finally with full legalization approved in Canada I believe that the United States and the world should follow. In doing so forgive the sentences of past and current non-violent cannabis offenders and expunge their cannabis related records. Finally, apologize for the destruction that the war on drugs has caused.
As for the others on this list. I recommend personalized treatment for substance abuse. Follow Portugal's lead and give help to those afflicted, not a criminal record!
May this world come together in peace. For we are far too divided.", "comment_id": "FDA-2018-N-3685-4879", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4879", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Adam Dochow", "commenter_fname": null, "commenter_lname": null, "comment_length": 907}, {"text": "Yes marijuana should be legalized or at the very least not be a schedule 1 drug. Alcohol is terrible, give people a chance to relax with a nice calming drug that you basically can't OD on. Reap the benefits of the tax money while creating a completely new Billion dollar industry. ", "comment_id": "FDA-2018-N-3685-4818", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4818", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Rsy Bartholow", "commenter_fname": null, "commenter_lname": null, "comment_length": 285}, {"text": "Cannabis is a medicinal herb that is well documented through history and is crucial to treating my glioblastoma that is predicted to kill me in six months if I can't access the herb. Classifying it as a schedule I drug is an abrogation of science, and criminalizing access and research is a crime against humanity. The only rational classification for the herb and its natural derivatives is none at all. Pharmaceutical derivatives introduce side effects, greatly increase cost, and significantly diminish the healing effect of the natural plant.
", "comment_id": "FDA-2018-N-3685-4886", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4886", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Carol Hiltner", "commenter_fname": null, "commenter_lname": null, "comment_length": 560}, {"text": "Yes, marijuana should be legalized. This will also accelerate research into the healing properties of the plant, which could lead to more uses for the different plant. ", "comment_id": "FDA-2018-N-3685-4984", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-4984", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Derek B", "commenter_fname": null, "commenter_lname": null, "comment_length": 169}, {"text": "Legality aside, schedule reduction for Cannabis Plant and Resin is more than warranted.
THC has a physically unreachable toxicity threshold, and causes no immediate threat to health. Alcohol, a legal and controlled substance, has a toxicity threshold among the lowest of all substances; the CDC reports "During 20102012, an annual average of 2,221 alcohol poisoning deaths (8.8 deaths per 1 million population) occurred among persons aged 15 years in the United States." which makes it one of the leading causes of preventable deaths in the United States for that time frame. Comparatively, cannabis use has caused 0 toxicity related deaths in not only the same time frame, but all of recorded history.
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6353a2.htm
CDC reports pertaining to other drugs currently on the same schedule, and drug overdoses in general:
"During July 2016June 2017, among 11,045 opioid overdose deaths, 2,275 (20.6%) decedents tested positive for any fentanyl analog, and 1,236 (11.2%) tested positive for carfentanil. Fourteen different fentanyl analogs were detected."
https://www.cdc.gov/mmwr/volumes/67/wr/mm6727a4.htm
"In 2016, there were more than 63,600 drug overdose deaths in the United States."
Factually, none of these were caused by the consumption of cannabis. That's 63,600 Americans who died in one year because they consumed too much alcohol, or too much of any other drug. 0 Americans have ever died as a direct result of consuming too much cannabis.
https://www.cdc.gov/nchs/products/databriefs/db294.htm
Setting aside arguments which could be made for recreational legalization at a federal level, and for the theraputic effects of other non-psychoactive substances (such as CBD, cannabinoids, and terpenes; anything not THC) that are present in cannabis, it's plain to see that the drug is not dangerous enough to remain on the Schedule 1 controlled substances list.
If the FDA truly has the American Public's best interests at heart, then cannabis will be removed from the schedule 1 controlled substances list, as a first step in the right direction. ", "comment_id": "FDA-2018-N-3685-5016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5016", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from James Ota", "commenter_fname": null, "commenter_lname": null, "comment_length": 2207}, {"text": "With the now long history of successful cannabis distribution in the medical fields, it no longer makes sense to have it banned as a highly dangerous substance. Coupled with the data showing increased safety and reduction in crime in states with recreational legality, the federal ban is no longer sensible.
With a state level choice by citizens to determine availability and true ability to research usage, we are best able to stop the problematic sides of the issue. Real research can be done to find both the positives and negatives of cannabis usage by the public. Children can be better insulated in the same fashion as they are for alcohol and tobacco plus the criminal justice system will be more efficient. The cost of criminalizing cannabis far outweighs the benefits and the volume of low level prosecutions stops prosecutions for high level crime.
So my opinion is that federal decoupling of legality and state level selective choice makes the most sense for the nation.", "comment_id": "FDA-2018-N-3685-5064", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5064", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Mich D", "commenter_fname": null, "commenter_lname": null, "comment_length": 989}, {"text": "The Cannabis Plant and Resin have already been legalized in many states, with even more putting it to a vote as soon as this coming November in one way or another. The "war on cannabis" happened long before we had our current scientific studying capabilities, and as such it has never had a true chance to be studied as a legitimate medicine. On top of this, the original reasons for its outlawing were highly suspect to begin with, chiefly influenced first by the business motivations of William Randolph Hearst (in conjunction with poorly attended congressional hearings and shoddy scientific studies), and later by the political motivations of the Nixon administration and the then burgeoning pharmaceutical industry, more than scientific merit. It's time we see the writing on the wall: If it won't be legalized for recreation at a federal level, the American people obviously want, at bare minimum, for Cannabis and Cannabis Resin to be changed to a Schedule IV or V drug so that it can be properly studied and the voters can make informed decisions on whether or not to continue its legalization.
Speaking of the current scheduling of Cannabis and Cannabis Resin, it's pretty difficult to make a coherent argument for how these drugs fit the description of other Schedule I narcotic. The definition for Schedule I narcotics per the DEA's website is as follows: "Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse." Not only do Cannabis and Cannabis Resin have currently accepted medical uses (treating epileptic seizures, for example), but how is it possible to assert that a drug has a high potential for abuse if there's a dearth of coherent, factual, peer-reviewed scientific study on that subject? Without scientific evidence the scheduling must be based on hearsay, and that our government would enact rules or regulations based on hearsay is a terrifying realization.
There are many other reasons why Cannabis and Cannabis Resin should be rescheduled but unfortunately there's simply not enough room in this comment to discuss them all. It's time to do right by the American people, and the ethical core that guides their principles, and reschedule Cannabis and Cannabis Resin to Schedule IV or V so it can be properly studied, after which the American people can finally be allowed to do their job: Make an educated decision on the ongoing legality of the substance.", "comment_id": "FDA-2018-N-3685-5068", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-N-3685-5068", "comment_date": "2018-10-29T04:00:00Z", "comment_title": "Comment from Jake Sparkman", "commenter_fname": null, "commenter_lname": null, "comment_length": 2528}]}, {"id": "FDA-2019-P-1679", "title": "Requests that the FDA revoke orphan drug designation for Sublocade (buprenorphine extended-release) injection for treatment of opiate addiction in opiate users, currently referred to as opioid use disorder", "context": "2019-11-07T16:23:01Z", "comments": [{"text": "Andrea G. Barthwell, M.D. D.F.A.S.A.M.", "comment_id": "FDA-2019-P-1679-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0046", "comment_date": "2019-05-09T04:00:00Z", "comment_title": "Comment from Andrea Barthwell", "commenter_fname": null, "commenter_lname": null, "comment_length": 39}, {"text": "See attached file(s)", "comment_id": "FDA-2019-P-1679-0072", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0072", "comment_date": "2019-07-25T04:00:00Z", "comment_title": "Comment from Edward Nunes", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "I know firsthand the devastation of the Opioid Addiction crisis. My husband and son have struggled with addiction for many years. My nonprofit organization Maryland Heroin Awareness Advocates (MHAA) is requesting the FDA to please strip the orphan designation granted to Sublocade.
Every individual is different and no single treatment will work for all of them. The more available treatment options we have will save lives, and are necessary to curb the massive deaths from opioid intoxication. This is definitely not a rare disease, and too many people who suffer don't have access to quality, long term treatment. We need to bring more medically assisted treatments to market not keeping treatments that have been found to be safe and effective off the market. The FDA needs to be on the side of patients and bring more treatments to the market.
The FDA should strip Sublocade of its orphan designation and ensure that more needed treatments are available to help stem this crisis.", "comment_id": "FDA-2019-P-1679-0048", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0048", "comment_date": "2019-05-14T04:00:00Z", "comment_title": "Comment from Maryland Heroin Awareness Advocates", "commenter_fname": null, "commenter_lname": null, "comment_length": 1009}, {"text": "Medication assisted therapy is proven to be effective for patients in abstaining from use and remaining in treatment programs as well as reducing their risk of overdose. Our options are currently limited and restrictive, as they dont provide many opportunities for patients with less than perfect adherence. Just as we have seen with injectable antipsychotic medication, removing the variable of adherence for such an important disease state keeps people healthy longer. Compared to schizophrenia, this often means saving lives for patients with opioid use disorder. The classic definition of an orphan drug does not apply to this product and we need access to as many tools as possible to help these patients. Allowing another medication option will only give us more versatility to treat all patients in a way that works best for them. ", "comment_id": "FDA-2019-P-1679-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0040", "comment_date": "2019-05-03T04:00:00Z", "comment_title": "Comment from Haley Pals", "commenter_fname": null, "commenter_lname": null, "comment_length": 838}, {"text": "A medication such as buprenorphine cannot he considered an orphan drug when it is being used as the principle medication to treat a disease that has been declared a public health crisis. The FDA has stated that they are invested in making it easier for new treatments to be made available for the treatment of opioid use disorder however their actions show otherwise. As a treatment provider who sees the damage this disease causes to individuals and their families, I see the urgent need to have every life saving treatment made available today and not in 7 years from now.", "comment_id": "FDA-2019-P-1679-0028", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0028", "comment_date": "2019-04-15T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 575}, {"text": "I write in my capacity as Professor of Psychiatry at NYU School of Medicine and as a NIDA-funded researcher focused on clinical trials for OUD. In the midst of an opioid crisis that affects several million people directly, plus family, friends, communities, there is a compelling need for a broad range of treatment options, and there seems to be no justification for orphan drug status, nor orphan disease exclusivity, neither on the basis of the size of the population, nor on the size of the market, nor exclusivity on the basis of "similarity." People need all of the pharmacotherapy options available, including various formulations (and durations of action) of buprenorphine, extended release naltrexone, methadone, etc. CAM2038, an alternative long-acting form of buprenorphine, differs substantially from Sublocade insofar as it can be initiated without a 7-day sublingual run-in period, making it the only long-acting opioid treatment that can be initiated directly in emergency departments (critical settings in which to intervene and save lives), and it does not contain NMP which precludes Sublocade use in pregnancy. ", "comment_id": "FDA-2019-P-1679-0031", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0031", "comment_date": "2019-04-17T04:00:00Z", "comment_title": "Comment from John Rotrosen", "commenter_fname": null, "commenter_lname": null, "comment_length": 1144}, {"text": "The opioid epidemic is taking lives in my community and impacting many people that I love. Granting orphan drug exclusivity will limit the treatments available to those who need them most. This makes no sense whatsoever. Right now, we need MORE treatments on the market, NOT less. Please reverse this terrible decision immediately.", "comment_id": "FDA-2019-P-1679-0030", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0030", "comment_date": "2019-04-16T04:00:00Z", "comment_title": "Comment from Matthew Harmon", "commenter_fname": null, "commenter_lname": null, "comment_length": 331}, {"text": "I am the Director and Founder of No More ODs, Inc. a Savannah Harm Reduction Coalition. We train and equip first responders, schools, restaurant staff, individuals or anyone that may come into contact with someone at risk of an opiate overdose, on how to identify an opiate overdose and how to reverse it.
After a life is saved, it is imperative to have resources available in order for the person to be able to live a healthy life of recovery. We need to be able to give options and choices to find the right fit for their Opioid Use Disorder.
I lost my son, Austin, to an opiate overdose 14 years ago. He didnt have the options available for a medically treated recovery. Granting orphan exclusivity to Sublocade would block other, needed treatments from being available to patients who need more options. Please do not grant orphan exclusivity to Sublocade, and please revoke its orphan drug designation. We need to ensure that patients can access to all safe and effective medications.
", "comment_id": "FDA-2019-P-1679-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0043", "comment_date": "2019-05-09T04:00:00Z", "comment_title": "Comment from Lesli Messinger", "commenter_fname": null, "commenter_lname": null, "comment_length": 1020}, {"text": "Hello. I am writing in reference to the petition being filed by Goodwin Procter against the FDAs decision to grant Sublocade orphan drug status. As a dual board certified Addiction Specialist and Family Medicine Physician, I work as a Regional Medical Director for CleanSlate Centers. We provide treatment to 13,000 patients in 11 states with OUD every day. I have personally had more than 15 years prescribing buprenorphine products.
On 1/10/18, Governor Wolf rightly declared the opioid epidemic an official statewide disaster in my home state of Pennsylvania following President Trump's declaration in October of 2017. Pennsylvania had 5559 opioid overdose related deaths in 2017. This is an all hands on deck disaster that demands every tool in the shed to be available for our patients.
I very much appreciate the benefit that buprenorphine related medications have brought to the table in treating this epidemic. I strongly believe that buprenorphine is directly accountable for countless lives saved during this crisis. I regularly see patients go from hopelessness to holding down a job and resurrecting their families in a matter of months or even weeks when they go through our program.
However, I firmly believe that as Alan Leshner, the former director of NIDA declared "All treatment works for some patients. No one treatment works for all patients". On the frontlines treating this epidemic, it is vital that we are given as many tools as possible. Indivior's product is a good product; however, it falls short in many instances. Having a product that is only injected once a week and indicated for induction in addition to maintenance in the treatment of OUD is invaluable.
I strongly urge you to please revoke the orphan drug status for Sublocade and allow other innovative people to continue to supply the medical world with much needed tools. ", "comment_id": "FDA-2019-P-1679-0047", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0047", "comment_date": "2019-05-09T04:00:00Z", "comment_title": "Comment from Todd Fausnaught", "commenter_fname": null, "commenter_lname": null, "comment_length": 1931}]}, {"id": "CNCS-2021-0018", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": "FDA-2023-N-0148", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": "FDA-2006-P-0148", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": "FDA-2009-P-0415", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": "FDA-2009-P-0289", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": "FDA-2015-P-1752", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": "FDA-2012-P-0818", "title": "Unknown Title", "context": "Unknown Context", "comments": []}, {"id": 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+[{"id": "FDA-2018-P-0673", "title": "Requests that the FDA produce a study on control of alprazolam products in relation to the overall effect on the Opioid crisis in the USA.", "context": "2021-02-17T17:40:12Z", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "Justice for Jake", "produce a study on control of", "alprazolam products in relation to the overall", "effect on the Opioid crisis in the USA", "OPEN"], "comments": [{"text": "If someone is poisoned by lacing punch, gummie bears or whatever, it is not the drugs fault, it is the person delberately tampering with the food, beverage committing murder. Does the date rape drug take the rap when someone puts it in another persons drink? Is it guilty of the crime?
Despite what ignorant individuals are stating, the only people suffering from the opioid crisis are the people that need the medication to live. The lives of people with horrible medical conditions have been destroyed. The lives of the elderly have been destroyed. The correct od stats are 17k. People do not take the time to fact check the current 'fad." Govt quietly corrects data while continuing to disseminate erroneous data,
MILLIONS OF PEOPLE WITH ILLNESSES WHO PREVIOUSLY WERE ABLE TO FUNCTION, CONTRIBUTE TO SOCIETY ARE NOW INCAPACITARED AND IN EXRUCIATING PAIN. YOU HAVE DESTROYED THEIR LIVES AND THEIR FAMILIES AND WE BY FAR OUTNUMBER THE POOR LITTLE ADDICTS WHO COULD CARE LESS ABOUT ANYTHING OTHER THAN GETTING THEIR ILLEGAL FIX ON THE STREET.
THE SICK ARE NOW COMMITTING SUICIDE DUE TO NONSTOP PAIN.
STOP PICKING ON PEOPLE WITH ILLNESSES OF ANY KIND.
THERE SHOULD NOT BE A SIGN IN A CANCER DOCTORS OFFICE STATING THEY CANNOT GIVE YOU THE MEDICATION YOU NEED FOLLOWING CHEMO AND RADIATION.
THE DEA LIES ABOUT DRUG SHORTAGES FOR THE SICK, WHILE THE FDA WEBSITE LISTS THEM AS SHORT.
IGNORANT AMERICANS YET TO BE AFFECTED BY THE FACT THAT PAIN KILLS CONTINUE TO PREACH WITHOUT KNOWING THE CORRECT STATS OR THE TRUTH.
PERSECUTION OF PEOPLE IN PAIN OR ANY ILLNESS NEEDS TO STOP.
MAKING IT HARDER FOR SOMEONE THAT MEDICALLY NEEDS OPIOIDS OR XANAX IS IRRESPONSIBLE.
Figures Lie and Liars Figure Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard Lawhern, National Pain Report, 11/17/17
http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.html
CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, JEFFREY A. SINGER, 3/22/18
https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-high
Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.
Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.
https://www.ncbi.nlm.nih.gov/pubmed/28402482
B.C. doctors cant limit opioids or discriminate against pain patients
CAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18
https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/
The Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17
https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935
The truth about the US opioid crisis prescriptions arent the problem
Marc Lewis is a neuroscientist/author on addiction, The Guardian
https://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptions
Fentanyl & Heroin Deaths Lead Soaring Overdose Rate, 12/21/17, PNN
https://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-meds
Why Untreated Chronic Pain is a Medical Emergency
1/28/18 by Pharmaciststeve http://www.pharmaciststeve.com/?p=23988
Untreated Chronic Pain can Kill! 6/20/17 Suzanne Stewart, NPR
http://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.html
CDC Report Ignores Suicides of Pain Patients, June 07, 2018, Pat Anson, PNN
https://www.painnewsnetwork.org/stories/2018/6/7/cdc-report-ignores-suicides-by-pain-patients
Jeffrey M Geurin, Staff Sergeant, United States Air Force 1997-2008
https://www.regulations.gov/document?D=FDA-2018-N-1621-1264
Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17
https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227
Response to: FDA-2017-N-5608
by: Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MD
U Alabama at Birmingham School of Medicine & Yale School of Medicine
https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938&attachmentNumber=1&contentType=pdf
Time: Report: Chronic, Undertreated Pain Affects 116 Million Americans
By Maia Szalavitz 6/29/11
http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/
10 Myths About the Opioid Crisis, Pnn
https://www.painnewsnetwork.org/stories/2017/12/24/10-myths-about-the-opioid-crisis
The other opioid crisis: hospitals are running short of powerful painkillers
PAULINE BARTOLONE, KAISER HEALTH NEWS
http://www.latimes.com/business/la-fi-opioid-painkiller-hospitals-20180316-story.html#
In the midst of a massive opioid crisis, hospitals are experiencing an opioid shortage
Aaron Schachter, 5/14/18
https://www.marketplace.org/2018/05/14/health-care/midst-massive-opioid-crisis-hospitals-are-experiencing-opioid-shortage", "comment_id": "FDA-2018-P-0673-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0007", "comment_date": "2018-08-10T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5323}, {"text": "We highly object. Making it difficult for people who legitimately need medication is not the way to stop overdoses from illegal street drugs which are many times laced with heroin. The majority of deaths are due to ILLEGAL drugs bought on the street. By restricting opioids and in this case xanax, you are only driving up the black market for these illicit drugs. People who actually need these medications are being denied access and in some cases are probably now desperate enough to try impure illegal drugs in order to manage medical conditions. Who benefits? The drug cartels which now have even more people to sell to as restricting access has now driven up demand. Since the crackdown on opioids began, we now have even more ER overdose cases. Guess what, they aren't from legitimate prescriptions, but street laced "copies" especially fentanyl. And for the record, someone could just as easily kill them-self with alcohol (a central nervous system depressant) tobacco, tylenol, aspirin, antihistamines...To combat illegal drugs, you should be looking to the DEA to crack down on drug cartels, pill mills and hey how about looking into those drug and alcohol Rave parties. Children and teens need to be properly educated by their parents. It is time for people to start taking responsibility for themselves and to stop blaming drugs. This is like blaming steak knives for every stabbing death and banning them. What about butter knives? They can kill as well. And knives don't just get up off the table and stab someone, just like drugs don't just jump out of their bottle into people's mouths or up their noses. There will always be something illegal on the street that entices some people to get high. Targeting legitimate prescriptions only creates additional suffering and hardship for those that need the medication, while those abusing it still have access to their illegal supply.", "comment_id": "FDA-2018-P-0673-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0004", "comment_date": "2018-03-19T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 1926}, {"text": "In order to ensure that Alprazolam (Trade Name Xanax) be more strongly controlled in distribution and use I support moving it from Schedule 4 to Schedule 2.
In the United States the drug continues to show up in overdose cases implicating it as a contributor to overdose situations which lead to hospital visits, temporary or permanent debilitation and death.
I find this petition to be in good order becamse Alprazolam has an actual and growing potential for abuse not only of the drug by itself but in combination with other drugs such as both the natural and synthetic opioids.
Scientific evidence of its pharmacological effect continues to indicate it is a serious mood, mind and body altering drug which must be distributed in only rare cases.
The state of current scientific knowledge regarding the drug's interactions with other drugs, such and natural and synthetic opioids as well as the psychiatric states it can trigger have been recorded in studies that the manufacturers continue to marginalize.
Over the course of its (relatively) brief history a pattern of abuse has arisen for the drug itself and it is now being used in combination with other drugs to create specific life endangering effects.
The scope, duration, and significance of abuse is increasing at a high rate over time. The control of the current supply has clearly been lost.
The risk there is to the public health continues to be loss of mental ability, physical ability and life. The debilitating effects of the drug lead to the curtailing of economic activities by family members which damage growing children, other family members and the entire community in which these tragedies occur. Death is also expensive.
The psychic and physiological dependence liability is clear and warned about. It is hard to manage with an individual of general intelligence and strength let alone someone suffering from the very symptoms this drug is supposed to alleviate.
", "comment_id": "FDA-2018-P-0673-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0005", "comment_date": "2018-07-25T04:00:00Z", "comment_title": "Comment from Alfred Brock", "commenter_fname": null, "commenter_lname": null, "comment_length": 2027}, {"text": "I am a 55 year old female and disabled since MVA in 2005. I am a RN and worked as a nurse for 35 yrs. I have had multiple surgeries due to the accident and also was diagnosed with Hep C that was contracted in the late 80s from a blood transfusion. I was infected for more than 20 years before being aware and it quietly destroyed my liver. I was blessed to bedcover a perfect match at the very last moment and I have been cured of the Hepc now. However I continue with severe chronic pain and my new liver has complicated my options for pain relief. My doctors had found the best medication for me wS Fentanyl patch. It worked well for me for many years. My life and activities were greatly improved. My liver health had been great for 5 years. Since the opioid rules I have lost two of my PCP because they could not prescribe to me. My liver enzymes have been spiking since they took the patch away. My BP has been extremely high at times. I have allergies to a few pain medications and many I simply cant have for reason of causing harm to my liver. Now being sent your in paon management clinics that insist on painful injections that I was told by my doctors I could not have. I pay huge copays and family must run me to appointments that last for hours. They never put hands involved me nor read my piles of records. They send me for repeated Scans MRIs and such for proof that I already have in my records. I am now on oxycodone pills that they previously took me off due to allergy. I continue to have pinching in my liver and my daily pain is 9-10. I never sleep through the night due to constant pain. I need more oregano surgeries but due to my health now I worry about the risks. My life now is very difficult I am depressed and tearful most days. I have 5 sons and 4 grandchildren and fur to my pain I rarely can participate with them and depression again.Before all of this Opioid crisis my quality of life was good. Pain was minimal and I enjoyed my family had normal relations with my husband. I even thought I could possibly work a few hours a week sitting at a desk. I very much miss my job as a nurse. Even if u could not go back to work at least I felt a timed I could be purposeful. Its no longer the case.all I can do now is happily retire and spend days enjoying life and my grandchildren Burbank thats option is gone. I have to have pain control and the proper medication that does not harm me. Like it or not Fentanyl worked well and I had complications. I seem to put that small percentage that. Policy and lawmakers has not considered. I refuse to have my life taken away after all I have been through. I want my PCP back and not be told he will risk losing his license to care for medical ", "comment_id": "FDA-2018-P-0673-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0006", "comment_date": "2018-07-25T04:00:00Z", "comment_title": "Comment from Denise R Niemi", "commenter_fname": null, "commenter_lname": null, "comment_length": 2717}, {"text": "I am a 41 year old disabled women. This is ridiculous on how Congress want to restrict the people who really need pain meds even more. I had to get 3 spinal surgeries and still have pain, muscle spasms, permanent nerve damage and pain. It is hard doing everyday activities. In my spine I have 15 titanium rods, 4 cages and 2 spacers. My back is permanently damaged. I have depression and anxiety disorder. It is a hassle to see the doctor and they consumed with the fear of prescribing pain meds. What are the people with real pain going to do? You guys are going at this wrong. Us economically disproportionate patients will suffer. The people with money will have access. I am tired of the lack of care. The state of Florida medical is worse. I am always compliant, get drug tested and go to my appointments. Why do I have to suffer?", "comment_id": "FDA-2018-P-0673-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0008", "comment_date": "2018-08-10T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 836}, {"text": "I object to this matter.
I have been on alprazolam for 4 years. Obtaining this medication was not simple. I had multiple breathing attacks during the day, I've had my left side go numb, and multiple physical symptoms due to severe anxiety. The stigma already surrounding mental health is a hindrance to individuals who seek care. Why make this more complicated thus increasing the likelihood of self medicating a mental issue? This issue would been seen heavier on other sides such as alcohol as patients self treat anxiety in ways not helpful. Stop hindering the accessibility to mental health, and medications used appropriately are far less likely to be abused, because when someone needs it, they don't feel it. I don't "feel" Xanax. I begin to have a normal heart rate and other symptoms gone. Yes counseling helped give me tools to help, but xanax is also a necessary tool. We deserve a quality of life. We did not choose this. ", "comment_id": "FDA-2018-P-0673-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0010", "comment_date": "2018-08-14T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 966}]}, {"id": "FDA-2022-D-1847", "title": "Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency", "context": "2022-11-03T13:44:18Z", "purpose": "Nonrulemaking", "keywords": ["CDER", "2022-329", "Exemption and Exclusion", "from Certain Requirements", "of the Drug Supply Chain Security Act", "for the Distribution", "of FDA-Approved Naloxone Products", "During the Opioid Public Health Emergency", "Open"], "comments": [{"text": "My son died September 11th, 2019 from an accidental overdose. He had overdosed twice before he died and it was only because of Narcan was he able to live another day. I have been talking to pharmacist, doctors, and the public in general and it is unbelievable how little they know about this lifesaving drug. I implore the FDA to please invest in a campaign of awareness concerning Narcan so that we can Save Just One. Someone dies every 5 minutes from an overdose or poisoning in this country. We are losing an entire generation.", "comment_id": "FDA-2022-D-1847-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0004", "comment_date": "2022-11-03T04:00:00Z", "comment_title": "Comment from LeAnne Burdette", "commenter_fname": null, "commenter_lname": null, "comment_length": 530}, {"text": "We are talking about lives here! The lives of the person who tried pot for the first time and it was laced with Fentanyl. The addict who couldn't no more and his overdose was a suicide attempt. We should have vending machines at every corner with Naloxone!. I understand regulations are necessary to keep individuals safe, but the individuals that need Naloxone are those not following regulations. I thank you for absolutely taking the initiative to lift regulations temporarily while we can get these numbers down. We should not limit a lifesaving medication by restricting it to prescription. Have not only harm reduction organizations carry it but recovery community organizations, rehabs, schools, libraries. Make it AVAILABLE! Easily accessible. ", "comment_id": "FDA-2022-D-1847-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0003", "comment_date": "2022-09-29T04:00:00Z", "comment_title": "Comment from Alex Grimes", "commenter_fname": null, "commenter_lname": null, "comment_length": 756}]}, {"id": "HHS-OS-2009-0007", "title": "Proposed Rule on Buprenorpine Dispensing In Opioid Treatment Programs", "context": "2019-01-11T01:04:12Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comment 4", "comment_id": "HHS-OS-2009-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0006", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # fr_doc_num", "commenter_fname": "Ronald", "commenter_lname": "Pike", "comment_length": 9}, {"text": "see attatched file", "comment_id": "HHS-OS-2009-0007-0008", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0008", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Elizabeth", "commenter_lname": "Stanton MD", "comment_length": 18}, {"text": "please see attached comments from the Cleveland Clinic", "comment_id": "HHS-OS-2009-0007-0003", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0003", "comment_date": "2009-07-20T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "blair", "commenter_lname": "barnhart", "comment_length": 54}, {"text": "Comment from Robert Newman, M.D.", "comment_id": "HHS-OS-2009-0007-0010", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0010", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Robert", "commenter_lname": "Newman", "comment_length": 32}, {"text": "Please see the attached PDF file", "comment_id": "HHS-OS-2009-0007-0014", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0014", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Thomas", "commenter_lname": "Merrill", "comment_length": 32}, {"text": "See attached.", "comment_id": "HHS-OS-2009-0007-0012", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0012", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Elinore", "commenter_lname": "Mccance-Katz, M.D.", "comment_length": 13}, {"text": "August 17, 2009
Re: Dockett No. CSAT 001, Proposed Rule Change for Buprenorphine Take Homes for Opioid Treatment Programs (OTPs)
At Texas Clinic, we started utilizing buprenorphine, specifically Suboxone, soon after it was approved for usage in our OTP. We have had great success with this medication, as it seems to have reached a new population of individuals addicted to opiates.
Our main problem from the very beginning in giving buprenorphine to our patients has been the cumbersome take home restrictions identical to those placed on methadone dispensing. We are constantly having to get exception requests for take homes while our colleagues in private practice were simply able to prescribe or dispense Suboxone with no such restrictions.
The take home restrictions have definitely been a deterrent to successful treatment. Over the years, we have had patients drop out of treatment while waiting for their take homes to be processed for approval or simply switch to a private practice (which actually cost them more) because they had freedom to work, go to school, or manage their household more easily.
We would strongly be in favor of lifting any take home restrictions on buprenorphine in OTPs and, therefore, amending the Federal OTP regulations as soon as possible. In this vain, we would further propose that an emergency order be issued, lifting such restrictions immediately, to avoid the possibility of any other patients leaving treatment, relapsing, and going back to a life of abusing opioids.
Thank you for allowing us to comment on this proposed rule change.
Sincerely,
Farrukh Shamsi, MBA
Executive Director
Texas Clinic Fulton
6311 Fulton St.
Houston, TX 77022
(713) 694-8100", "comment_id": "HHS-OS-2009-0007-0009", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0009", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Farrouk", "commenter_lname": "Shamsi", "comment_length": 1798}, {"text": "Please find comments by the American Society of Addiction Medicine, regarding the approval of take-home buprenorphine within OTPs, attached. (Docket No. CSAT 001) Thank you.", "comment_id": "HHS-OS-2009-0007-0007", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0007", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Alexis", "commenter_lname": "Geier-Horan", "comment_length": 175}, {"text": "See Attached", "comment_id": "HHS-OS-2009-0007-0011", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0011", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Charles", "commenter_lname": "O'Keefe", "comment_length": 12}, {"text": "See Attached.", "comment_id": "HHS-OS-2009-0007-0013", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0013", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Doug", "commenter_lname": "Kramer", "comment_length": 13}]}, {"id": "FDA-2011-N-0802", "title": "Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop; Request for Comments", "context": "2015-09-11T10:39:47Z", "purpose": "Nonrulemaking", "keywords": ["cder2011177", "CDER", "Naloxone", "Public Meeting", "Request for Comments", "2015-376", "open", "Exploring", "Uptake and Use"], "comments": [{"text": "Please see the attached letter from the American Association of Nurse Anesthetists.", "comment_id": "FDA-2011-N-0802-0045", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0045", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from American Association of Nurse Anesthetists (AANA)", "commenter_fname": null, "commenter_lname": null, "comment_length": 83}, {"text": "Please see the attached PDF document for comments submitted by the Drug Policy Alliance in reference to Docket No. FDA-2014-N-0998. Thank you.", "comment_id": "FDA-2011-N-0802-0047", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0047", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from Drug Policy Alliance", "commenter_fname": null, "commenter_lname": null, "comment_length": 142}, {"text": "I stongly support the increase availability of Naloxone in the prevention of Opioid Overdose. Making naloxone availalble saves lives! I work as a nurse on a adult detox center at the University of Minnesota, Fairivew and we have noticed an alarming upward trend of 18 y o to 28 y o heroin addicts. Most started with abuse of narcotics then switched to heroin. Many are motivated to come to treatment because a friend overdosed and died. Recently I cared for a young male who came in because he himself nearly died of an overdose but a friend did rescue breathing and got him to an ER. Unfortunetly this friend overdosed the next day and died. We just had a high school student overdose on heroin and alcohol and died. As a mother and a nurse I request you make naloxone and needles available to the public. One idea would be to have public health and/ or pharmacy's distribute the medication/syringes after a person views an informational adminstartion/safety video on an i-pad.
As a community in the Twin Cities we organized a multi -agencyOpioid coaltion to fight this horrific trend of young opioid abusers. Availability of Naxolone is one layer of a solution to this problem. Additonal prevention and public education measures are urgently needed for this nation wide epidemic.
Thank you,
Mary Kay Borgstrom RN
Opioid Coalition Prevention Leader
www.opioidcoalition.org", "comment_id": "FDA-2011-N-0802-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0006", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Mary Kay Borgstrom - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1403}, {"text": "See attached file(s)", "comment_id": "FDA-2011-N-0802-0044", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0044", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from CVS Health", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Working in Massachusetts on the opioid overdose prevention initiative has been one of the most fulfilling times of my professional life. Teaching a parent or loved one of an opioid addict, who is consumed with the fear of losing their loved one to overdose, how to reverse an overdose with nasal naloxone is unparalleled. Most people are amazed at how easy it is to save someone's life with this medication. There is so much misinformation around naloxone that it is crucial to educate the public on its use and importance in our society. None of us can change the fact that presently we are literally fighting for peoples' lives when we talk about opioid abuse, but we can save people from dying from an overdose. An overdose often opens the door for people to reevaluate their situation and look at treatment as a viable option. I did a focus group a few weeks ago and this came from a participant: "I don’t use drugs, but I have been here a lot, I’m an alcoholic. I have had alcohol poisoning and I was lucky to survive. So when I took your class I thought it was important to get Narcan, because you never know. I left here and went to a sober house. My first day in the house, a young kid overdosed on heroin. I used that Narcan and saved his life. I called 911, they came, they took him to the hospital, no issues. I need to get more Narcan. It’s important that alcoholics know that it does apply to them, it applies to everyone if you can save someone’s life. "", "comment_id": "FDA-2011-N-0802-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0004", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Hillary Dubois - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1521}, {"text": "Please see the attached PDF for our comments submitted in collaboration with the American Pharmacists Association. Also, the National Alliance of State Pharmacy Associations would like to again express our appreciation for the opportunity to participate in and serve as a panelist at the FDA meeting: Exploring Naloxone Uptake and Use. Thank you.", "comment_id": "FDA-2011-N-0802-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0046", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from National Alliance of State Pharmacy Associations and American Pharmacists Association", "commenter_fname": null, "commenter_lname": null, "comment_length": 346}, {"text": "Many news and research articles have been decrying escalating trends in overdoses and deaths from opioid analgesics and heroin. Yet, rarely is mention made of the fact that there is an effective and safe antidote for such tragedies — naloxone. Isn’t it time to stop the complaining, and conducting pilot studies, and to start using naloxone on a broad scale to finally address and ameliorate the problems?
Evidence-based comments by Stewart B. Leavitt, MA, PhD, executive director of the Pain Treatment Topics and Opioids911-Safety education projects are in an attached MS Word document.", "comment_id": "FDA-2011-N-0802-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0003", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Pain Treatment Topics (Pain-Topics.org) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 608}, {"text": "Hello,
The United States is a leader in preventing overdose deaths with the use of naloxone.
People from all over the world utilize the resources that have been produced in the US about naloxone. The US has the experience, research, and expertise to respond to this preventable epidemic; leading the way for so many other places.
Having naloxone empowers all parties to engage in meaningful and educational dialogue about the risks associated with substances.
", "comment_id": "FDA-2011-N-0802-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0016", "comment_date": "2012-06-13T04:00:00Z", "comment_title": "Erin K Gibson - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 500}, {"text": "Naloxone use by VA Police in a first responder role outside the VA Hospital on VA grounds or City property requires
regulations to outline clear authority for use.
The Minneapolis VA has extended the naloxone rescue kits to providers to prescribe to patients, in addition, seek to
enable our VA police officers to be trained and have clear authority to administer a potential life saving medication for
opioid overdose.
I have been unable to establish authority for VA Police to administer naloxone (prescription medicine) under a
standing order because a standing order for naloxone is for an unknown patient.
I have asked our VA Legal counsel but no information is available.
The VA Police Chief here in Minneapolis wants naloxone rescue kits available in the medical kits used by the VA officers.
Clinical staff want this as well.
VA Police officers are first responders to off-site areas(not in the hospital) that include apartments on this campus
and must call 911 for city ambulance response if needed. Naloxone could be useful.
Past history does include a drug overdose at VA run apartments, sadly naloxone would not have helped in that case.
The Chief anticipates need. Pharmacy Service will commit to training the officers in opioid overdose avoidance, recognition
and response.
", "comment_id": "FDA-2011-N-0802-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0040", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from Gary Zielke", "commenter_fname": null, "commenter_lname": null, "comment_length": 1372}, {"text": "The FDA should act swiftly to make naloxone available over-the-counter. Increased access to naloxone will help save the lives of opioid users who often do not receive professional medical help because of the fear of police involvement. The majority of studies that compare different reasons for delaying or foregoing a call for assistance find that fear of police involvement is the most commonly cited reason. I attached an additional file which contains more details on the relevant empirical research. These findings make a compelling case for expanding the availability of naloxone. Even if fear of police prevents the seeking of professional medical assistance, the administration of naloxone by a witness can still save a life. And since it is unlikely that the fear of police will be completely eliminated in the near future, naloxone must be a critical part of comprehensive overdose prevention plans. As of April 11, 2012, only six states grant help-seekers and victims limited immunity from prosecution for possession of controlled opioids. Even in states that have enacted these 911 Good Samaritan protections, awareness of the law may remain low. For example, a year after Washington passed their 911 Good Samaritan law, only one of out of six of Seattle police had heard of it and only one out of three opioid users had heard of it. Furthermore, no state has extended Good Samaritan immunity to distribution offenses, despite the fact that most nonmedical opioid users obtain these drugs from friends or relatives who share or sell them. In this context, naloxone must be available to ensure that fear of punishment does not inadvertently condemn overdose victims to a death sentence.", "comment_id": "FDA-2011-N-0802-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0007", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Jeffrey Joseph Cece - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1706}]}, {"id": "CMS-2019-0111", "title": "Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2020 (CMS-1715-P)", "context": "2020-10-16T21:14:52Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Sept 12, 2019
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS1715P
P.O. Box 8016
Baltimore, MD 212448016
RE: Medicare Program; CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and
Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid
Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an
Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of
Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper
Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion
Regulations [CMS-1715-P]
Dear Administrator Verma:
I am writing in response to the request for comments on the Centers for Medicare and Medicaid Services
(CMS) Calendar Year (CY) 2020 Revisions to Payment Policies under the Physician Fee Schedule (PFS)
and Other Revisions to Medicare Part B proposed rule.
I am a physical therapist assistant and am concerned about this potential regulation change. Physical therapy and occupational therapy services are critically important for improving patient function in order to return home or maintain their highest level of independence and quality of life.
I appreciate the opportunity to provide feedback to CMS on the proposed rule. Specifically, I am writing
in response to CMS proposed application of the CQ/CO modifier when outpatient physical therapy and
occupational therapy services are furnished in whole or in part by a physical therapist assistant (PTA) or
occupational therapy assistant (OTA).
I understand that Section 53107 of the Bipartisan Budget Act of 2018 (BBA), enacted on February 9,
2018, included the assistant adjustment as a pay-for provision related to the repeal of the Medicare Part B
payment cap for therapy services. However, if finalized as proposed, this policy will negatively affect
Medicare beneficiary access and add administrative burden. Further, if the application of the modifiers is
finalized as proposed, the access to and safety of vital outpatient physical and occupational therapy
services for the most vulnerable physically impaired beneficiaries will be compromised.
I ask the Secretary to not finalize these policies as proposed. Instead, I am requesting that CMS, in
finalizing the therapy assistant adjustment provisions of Section 1834 of the BBA, implement the
following policy:
1. When a therapist and assistant are jointly furnishing services to a patient at the same time as a
team, and the therapist is fully engaged in the service during that time, the service during that
time period should be identified as a therapists services and be allocated to the therapist.
2. That CMS define in whole or in part to mean skilled therapy service furnished by a PTA or an
OTA that is furnished under the supervision of a therapist, but independent of any time the
therapist is furnishing the service.
3. That only those units of services provided in whole or in part by the assistant should be subject
to the 10% de minimis standard, the CQ/CO modifier, and subsequently the 15% payment
adjustment, not all units of the entire therapy service.
4. That no new burdensome documentation requirements be added. At a maximum, sub regulatory
guidance could revised to include a statement such as The provider should have a mechanism in
place to provide evidence whether a specific service was furnished independently by a therapist
or an assistant, or was furnished in part by an assistant in sufficient detail to permit the
determination of whether the de minimis threshold was met.
Thank you for the opportunity to comment on the CY 2020 Medicare Physician Fee Schedule and
proposed rule.
Sincerely,
Alvin Fall
PTA", "comment_id": "CMS-2019-0111-6442", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6442", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 4096}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary."
", "comment_id": "CMS-2019-0111-6412", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6412", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1988}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6590", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6590", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1972}, {"text": "Thank you for recognizing and addressing the disparity between student documentation requirements for teaching physicians and their students and those for advanced practice nurses (APRNs) and physician assistants (PAs) preceptors and their students. Currently, CMS allows teaching physicians to review and verify any student documentation of the components of E/M services in the medical record, rather than re-document the work. However, this burden reduction policy was not applied to APRN/PA preceptors and their students. Excluding APRN/PA preceptors and their students from this policy had the unintended effect of heightening the challenge of securing preceptors for APRN/PA students when teaching clinicians are in short supply. The revision contained in the Medicare Physician Fee Schedule proposed rule will authorize all APRNs /PAs and physicians to review and verify rather than re-document work for all E/M services by all members of the medical care team (including APRN/PA students). This will remove the disparity and lead to parity among providers and burden reduction for all clinicians. Therefore, we support the inclusion of APRN/PAs in the proposed rule.
For additional information, please contact the AANP Government Affairs Office at 703/740-2529 or governmentaffairs@aanp.org.", "comment_id": "CMS-2019-0111-6713", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6713", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1348}, {"text": "As a physical therapist and employer of 5 Physical Therapists assistants, I urge the payment policy be reviewed and deemed not beneficial for patient care. The use of physical therapists assistants in the healthcare world is vital for efficiency and quality. The proposed decrease in reimbursement will negatively impact employment and likely lead to additional shortages of rehab professionals through the country. I fully understand the need for cost containment however strongly disagree with this methodology. I urge your committee or group to reconsider the payment reduction.
Sincerely, Joe Walters PT
Owner, Physical Therapy One
Portage, MI 49024 ", "comment_id": "CMS-2019-0111-6706", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6706", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 671}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6705", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6705", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1972}, {"text": "CMS,
I strongly disagree with the CY 2020 Medicare Physician Fee Schedule Proposed Rule update to certain CPT codes for cardiac PET Imaging (CPT codes 78491, 78492, 78x31, 78x32). I disagree with this policy as it is based off of incorrect data and observation. It appears that inaccurate overhead data, a lack of thorough survey inputs and non-"real world" assumptions have caused Medicare and the RUC to recommend changes to the work inputs associated with Direct Expense and Practice Expense values, that combined with an inaccurate utilization rate resulted in a proposed reimbursement decline that is significant enough to make it impossible for facilities to continue to offer cardiac PET services after January 1, 2020.
The RUC and Medicare relied on market survey data to provide inputs for calculating the technical component (TC) reimbursement. These flawed surveys provided incorrect data or incomplete data regarding equipment direct expense, utilization rate, and practice expense inputs. In addition, the surveys failed to assess the true cost of starting, operating, and maintaining a cardiac PET lab, omitting input allowances for numerous high cost requirements. Therefore, based on this flawed survey data, both the RUC and Medicare recommended a reimbursement value well below what is necessary for the technical operation of a cardiac PET laboratory. I request that CMS NOT commence with the proposed reimbursement in 2020 and instead allow reimbursement to continue at current levels.
", "comment_id": "CMS-2019-0111-6759", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6759", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1543}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule. Thank you for taking the time to review these comments.
Sincerely,
Pamela Thurman
726 Marina Village Dr
Grand Rivers, KY 42045-9010
", "comment_id": "CMS-2019-0111-6644", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6644", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1838}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.
Sincerely,
Ursula Waller
128 Marshall Rd
Buckhead, GA 30625-2906
", "comment_id": "CMS-2019-0111-6631", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6631", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1770}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.
Sincerely,
Jaclyn Taylor
108 S Elmhurst Ave
Mount Prospect, IL 60056-3125
", "comment_id": "CMS-2019-0111-6629", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6629", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1779}]}, {"id": "DOD-2013-HA-0085", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\r\nTRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE For Life Beneficiaries through the TRICARE Mail Order Program", "context": "2020-10-22T01:33:13Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "i BELIEVE THE EFFECTIVE DATE OF THE RULE FOR OPTING OUT SHOULD BE EARLY IN 2013 AS MANY OF US BEGIN USING MAIL ORDER AT THAT TIME IN ACCORDANCE WITH THE LAW.....NOW YOU BACK IT OFF UNTIL February 14, 2014. IT WAS NOT THE BENEFICIARY FAULT THAT THE PHARMACY BENEFIT MANAGER WAS NOT READY TO IMPLEMENT THE LAW....ITS A FIVE YEAR PROGRAM AND SOME OF US PLAYED BY THE RULES AND NOW FIND WE ARE PENALIZED. AFTER WELL OVER A YEAR IN THE PROGRAM, THE MAJOR PROBLEM IS THE LACK OF ABILITY TO COMMUNICATE WITH EXPRESS SCRIPTS....IN WELL OVER A YEAR, WE HAVE NOT COMMUNICATED WITH A PHARMACIST OR EVEN A TECHNICIAN. WE HAVE NO IDEA THE QUALIFICATION OF THE SO CALLED ADVOCATES IN PHARMACOLOGY. THE RULES FOR OPTING OUT AND FOR A WAIVER SHOULD BE MUCH MORE SPECIFIC. EXPRESS SCRIPTS WORKS HARD ON KEEPING THE MEDICATIONS ON TIME....BUT GOD FORBID IF THE PHYSICIAN CHANGES THE mg OR THE DRUG....IMPOSSIBLE TO COMMUNICATE THE ISSUE WITH THEM IN TIME TO MEET THE DEMANDS OF THE MEDICATION. I ALSO QUESTION YOUR SAVINGS FROM THE PROGRAM...IN A RECENT DOD/IG REPORT THEY SAY THE PROGRAM IS A WASTE OF MONEY......WHEN AND WHERE WILL THE LIST OF SELECTED MEDICATION FOR MAIL ORDER BE POSTED? .THANK YOU FOR LETTING ME COMMENT. ", "comment_id": "DOD-2013-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0002", "comment_date": "2014-01-17T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 1211}, {"text": "See attached file(s)", "comment_id": "DOD-2013-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0004", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached comments of the National Association of Chain Drug Stores.", "comment_id": "DOD-2013-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0003", "comment_date": "2014-02-10T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 78}, {"text": "Please see attached comments from the Iowa Pharmacy Association.", "comment_id": "DOD-2013-HA-0085-0005", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0005", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 64}, {"text": "See attached file(s)", "comment_id": "DOD-2013-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0007", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached comments from the Pharmaceutical Care Management Association.", "comment_id": "DOD-2013-HA-0085-0006", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0006", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 81}]}, {"id": "DEA-2020-0002", "title": "Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl into Schedule I", "context": "2021-12-02T01:00:58Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "In light of growing number of opioid overdose deaths in America (more than 70,000 people died of opioid overdose in 2017 according to the CDC), I support the permanent addition of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl to list of Schedule 1 drugs. These drugs are structurally similar to the opioid fentanyl but are not FDA-approved drug products. As a result, users of these drugs are not protected by the FDA's quality standards. According to the CDC, abusing unregulated opioids of unknown quality and potency represents a significant risk of opioid overdose to users. Opioid overdose has been estimated to cost the United States more than 400 billion dollars annually (according the White House Council of Economic Advisors). Additionally, I argue that the social and emotional damage done to American communities caused by the opioid overdose epidemic cannot be presented solely financial terms. In an effort to minimize the presence of unregulated opioid substances of unknown quality and potency in illicit drug markets, I support the listing of these subtances as Schedule 1 drugs, as they meet the DEA's requirements for Schedule 1 subtances. ", "comment_id": "DEA-2020-0002-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0011", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Brian", "commenter_lname": "Rogers", "comment_length": 1287}, {"text": "Why don't you get a chemist to make a list of all the chemical pictures that cause drug addicts who are using fentanyl to feel satisfied so that we don't do this stupid add five chemicals and China imports four hundred variants. The solution is to list every fentanyl variant as schedule 1.", "comment_id": "DEA-2020-0002-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0009", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 298}, {"text": "The proposal to reschedule fentanyl to schedule one under the Controlled Substances Act though honorable in intent, may potentially do more harm than good. A large portion of our population relies on controlled substances, such has fentanyl, to relieve their chronic pain. While these drugs were never meant to be a long-term solution, that has become the reality we must deal with. Rendering fentanyl illegal would leave many patients in a lurch, unable to access the care they were previously receiving. These patients would no doubt either receive a prescription for a different opioid or worse, obtain illicit substances to fill the void they are now left with. While prescription drugs make up a great portion of the opioid epidemic and I agree that alternative therapies need to be established, it would be foolish to forget the schedule one substances that are already contributing to this nation-wide crisis. The majority of fentanyl related deaths are due to its mixture with other substances that are already classified as schedule one. Creating more illegal substances will not solve the issue, rather add fuel to the fire that is the illegal drugs trade. ", "comment_id": "DEA-2020-0002-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0006", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1167}, {"text": "Here's a article reported by CNN's Madeline Holcombe which explains everything we need to know about the fentanyl crisis that we are dealing with here in central Ohio: "This Ohio county (Franklin) may need a second morgue to handle the number of fentanyl overdoses." [1]
In her article, Holcome discusses the opioid scourge that is heavily affecting my home state. The article stated that [Franklin] county has seen 23 overdose deaths from January 31 to February 7, Dr. Anahi Ortiz, the county's coroner, said in a statement on her Facebook page. The next day, the county had five more. Dr. Ortiz also stated that [fentanyl] is the deadliest drug in the US, according to the Centers for Disease Control. It is up to 100 times more powerful than morphine, and just .025 milligrams can be deadly.While Franklin County usually has one or two overdose deaths in a day, Ortiz said on Facebook, one 26-hour period in September 2019 saw 10 people dying of overdoses.That year, overdose deaths in the county were up 15% from the year before, and 90% were opiate related.
Fentanyl is a drug that affects everyone and is not limited to race, income, social class, age, education level, etc. It is a killer and can be fatal on someone's first dose because of its potency and the chemicals it is mixed with for the purpose of "cutting" it for sale on the street and larger profits for the dealers.
I have never had a friend or relative killed or had their lives destroyed by it, but I believe that I am in the minority. Almost everyone has been impacted by these drugs. We have all watched the news reports, watched documentaries, seen the impacts of the drugs in TV shows or movies... everyone knows it is a problem which needs a solution ASAP! We need to make it a schedule 1 narcotic and take every legal step to eliminate fentanyl from our streets, or neighborhoods, our schools, and our homes. Fortunately we are in the process of closing/controlling entry on our southern border where most of this lethal drug is being smuggled in from central and southern America. There is no simple, single solution to combating this fentanyl plague, all possible solutions need to be taken, and reclassifying fentanyl to a schedule 1 drug is a necessary step to take.
[1] Madeline Holcombe, This Ohio county may need a second morgue to handle the number of fentanyl overdoses, CNN, (February 13, 2020), https://www.cnn.com/2020/02/13/us/ohio-fentanyl-overdose-second-morgue/index.html.
Thank you for considering my comments and concerns.
Respectfully,
James E. Yerian
", "comment_id": "DEA-2020-0002-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0008", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "James", "commenter_lname": "Yerian", "comment_length": 2663}, {"text": "This is a drug I think is abused by people by age and it is terrible to see it get worse year by year. I am glad that people will be punished at a higher degree of law if they are using these drugs to ruins the lives of others by providing a source for this drug. I hope that this reclassification will prevent further deaths and addiction.", "comment_id": "DEA-2020-0002-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0010", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Jose", "commenter_lname": "Vargas", "comment_length": 340}, {"text": "Yes, this is good because the drug dealers are the words and much worse than the users.", "comment_id": "DEA-2020-0002-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0007", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Lily", "commenter_lname": "Grant", "comment_length": 87}]}, {"id": "SAMHSA-2022-0001", "title": "Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) (Revised)", "context": "2022-06-14T14:14:08Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "This is completely absurd and unjust! It is time to move past these destructive policies. If a person's physician believes it is in one's best interest to use a medicine, then the federal government should not be able to hold this against the person due to a failed test. This is very un-American! Cannabis is a very safe, and effective medicine. We should embrace it as such.", "comment_id": "SAMHSA-2022-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0007", "comment_date": "2022-04-13T04:00:00Z", "comment_title": "Comment from Richard Rousseau", "commenter_fname": "Richard", "commenter_lname": "Rousseau", "comment_length": 384}, {"text": "Although I believe Oral Fluid testing is a good thing for quick non dot testing, I think it is offering many opportunities for Cheating for DOT testing. There will be more and more companies that will begin to do their own testing with their Employees which leaves the opportunity for friends and colleagues testing each other and promotes collaboration between Staff and Employee", "comment_id": "SAMHSA-2022-0001-0023", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0023", "comment_date": "2022-04-26T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Bill", "commenter_lname": "Kincaid", "comment_length": 381}, {"text": "I believe that medical cannabis users should be exempt from fedral drug screen failures.", "comment_id": "SAMHSA-2022-0001-0022", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0022", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 88}, {"text": "his is slightly insane but a logical outcome of the federal government’s continued refusal to change its outdated, disproven, and harmful categorization of cannabis as a Schedule I drug.", "comment_id": "SAMHSA-2022-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0019", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Alexi", "commenter_lname": "Martinez", "comment_length": 192}, {"text": "This rule is founded on completely archaic ideas about cannabis and how it affects an individual. There is no science backing up the non-legitimacy of medical use cases for cannabis where in many circumstances, actually improves the life of the person who uses it. Personally I have suffered from high anxiety/depression and PTSD and using cannabis before bed helps me immensely to calm down and get good rest. Without it I typically have night sweats/terrors that severely affects my performance the next day. Using cannabis before bed however allows me to function fully the next day and show up to work and other responsibilities with a clear and balanced mind. The harmless nature of this drug truthfully should allow it to be legal federally. Even for non medical patients, it is far safer to be taken recreationally than something like alcohol. Having cannabis be a schedule 1 drug is completely erroneous but while states have laws allowing it to be used medically, we should honor that and not move retroactively. Progress needs to be made here to establish facts about cannabis instead of digging in our heels based off assumptions made by politicians from decades ago. More and more research is coming out showing the benefits of cannabis and how truly harmless it can be. We need to be a country that creates rules based off these facts in order to maintain the sense of freedom that we cherish here. ", "comment_id": "SAMHSA-2022-0001-0021", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0021", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment from Eric Florence", "commenter_fname": "Eric", "commenter_lname": "Florence", "comment_length": 1412}, {"text": "SAMHSA 2022-0001 is a throwback to a relic of reefer-madness legislature. All of this is the politically neurotic outcome of the federal government’s continued refusal to change its outdated, targeted, and medically harmful categorization of cannabis as a Schedule I drug. Please look yourself in the mirror and explain this, “a physician’s authorization or medical recommendation for a Schedule I substance is not an acceptable medical explanation for a positive drug test.” I'll help, it's a back asswards loophole to apply to try to regulate an innoxious substance. It's also funny how the most addictive substances known to man are considered safe enough to assign to Schedule II; live with yourself knowing that you helped fuel a crisis that ruins lives and kills people because of a nonsensical mindset of ignorance, greed, and fear. You won't read it but here's to you, cheers; https://www.npr.org/2022/02/25/1082901958/opioid-settlement-johnson-26-billion, https://www.newsnationnow.com/health/where-do-us-opioid-trials-settlements-stand/.", "comment_id": "SAMHSA-2022-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0011", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1091}, {"text": "As a qualified SAP from 05 to present I am in support for Oral Fluid Testing but with the following caveats: 1) ONLY Urine Testing should be used for the RTD Return to Duty test. 2) There should be no change to the SAP being the sole author of any employee's mandatory Follow up Testing Plan. The SAP is the one in the entire RTD process who is spending up to hours of time providing a clinical assessment and applying diagnostic criteria with backend recommendations for education or treatment or both. Thus, upon any employee compliance the SAP should be the only Service Agent type deciding the amount of Follow-up Tests but also if they recommend ORAL or URINE for Follow-up tests. I would advise that all Follow up Tests are URINE TESTS only. The Oral Test appear from what I read to be the way to go for Pre-employment Test, Random's, Reasonable Suspicion, Post Accident etc but the RTD and Follow up Test should ALWAYS be Urine based. If there is a choice on either for Oral and Urine testing for RTD and Follow-up Testing this call should ONLY be for the contracted SAP to make and never the employer or 3rd party TPA. ", "comment_id": "SAMHSA-2022-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0027", "comment_date": "2022-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 1135}, {"text": "Comment on SAMHSA 2022-06884
I am an operations manager at a public transit authority and think adding the ability to conduct drug testing using oral fluids will be a benefit felt across the board. Our organization would certify staff to be able to self administer oral fluid testing as well as use a clinic. Drivers would still have to go to a clinic for BAC testing, so we would not self administer that test. It takes a lot of planning and resources to pull drivers off route for random testing, send them to the clinic, wait at the clinic, then coordinate getting them back on route. Being able to self administer random testing will simplify the process and make it more convenient to test at all times of service.
Our practice would be to use urine tests for pre-employment, return to duty, and follow up. In the cases of shy bladders or the inability to produce a large enough specimen, we would be open to transitioning from urine to oral fluids before exhausting the time limit. We prefer pre, return, and follow-up to be more structured through a clinic and to use urine, especially for return and follow-up.
In response to the question of whether or not to allow opposite gender techs to observe urine collection, our team was split. The male point of view was it makes no difference. The human resources and female recommendation was to have it observed by the same gender. Past experiences show female staff were already stressed about being observed. To have the collection observed by a male would further exacerbate the situation. Just because someone is going through the follow up process doesn't mean they should lose their dignity. We understand in smaller communities it may be harder to find same gender techs to observe urine collections, but we don't have the issue in our area.
In response to the question of whether or not refusing an opposite gender observer constitutes a refusal to test, we assumed that the regulation wouldn't require same gender observers. We would recommend calling that a refusal to test. If your test requires observing, you must have already tested positive. We cannot give someone the ability to cheat the system if they know there aren't many same gender techs.
In summary, let's get oral fluid testing up and running and relieve some of the burden placed on organizations to maintain compliance with drug testing. A separate soap box issue I would like to see movement on is THC levels testing to remove the current zero tolerance policy that can last for up to 60 days after last contact/consumption. Safety sensitive industries need a better answer than zero tolerance when cannabis products and marijuana use are rising as fast as they are now. Zero tolerance is hurting staff retention and recruiting. ", "comment_id": "SAMHSA-2022-0001-0030", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0030", "comment_date": "2022-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 2811}, {"text": "Comments of Airlines for America attached.", "comment_id": "SAMHSA-2022-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0040", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 42}, {"text": "Official comment from OraSure Technologies, Inc. is attached.", "comment_id": "SAMHSA-2022-0001-0038", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0038", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 61}]}, {"id": "SAMHSA-2023-0001", "title": "Medications for the Treatment of Opioid Use Disorder", "context": "2023-05-08T13:37:08Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I think it would benefit greatly if Telemed appointments were permanently available for inductions/first visits.", "comment_id": "SAMHSA-2023-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0007", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Powell, Kennedy, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Kennedy", "commenter_lname": "Powell", "comment_length": 112}, {"text": "As a public health professional, I strongly urge SAMSHA to adopt the proposed changes to medications for opioid use disorder (MOUD) regulations to increase access to these lifesaving medications and enable people with substance use disorder (SUD) to successfully discontinue illicit drug use and reclaim their lives. I currently serve as deputy director of Virginia Harm Reduction Coalition, a 501(c)(3) nonprofit providing harm reduction services to people who use drugs (PWUD) in Southwest Virginia. I have witnessed firsthand the struggles our clients face in accessing MOUD, including not being able to afford to take time off work for appointments and facing stigma at work when they do, difficulties with getting childcare to facilitate appointments, and difficulties obtaining transportation to access appointments. I have witnessed clients struggle mightily to remain in treatment only to finally succumb to the weight of these barriers and relapse. The closest Medicaid-accepting methadone clinic to Roanoke, Virginia, is located 50 miles away in Martinsville. Methadone is much more effective for many of our clients than buprenorphine (especially since Virginia law makes obtaining buprenorphine without a naloxone component impossible for most patients). The availability of telehealth appointments for methadone patients and the ability of patients to receive up to 4 weeks’ worth of medication enables many more of our clients to enter and remain compliant with treatment. It is an absolute game changer. ", "comment_id": "SAMHSA-2023-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0014", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Zabielski, Barbie, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Barbie", "commenter_lname": "Zabielski", "comment_length": 1526}, {"text": "While I absolutely believe addiction and addiction issues are a significant problem, I wanted to make sure that my understanding (and my doctor’s understanding is correct as it was told to me, a pain patient). The proposal’s wording leaves no choice for someone taking opioids to NOT be dependent either physically or mentally. Meaning, it is appropriate to code all patient’s claims who use opioids as at least “opioid dependence” diagnosis. They have no choice to do this even if their doctors have zero dependency concerns documented in the medical chart. Even if the patient has no dependency issues with the opioid(s) being taken. And I am assuming there will be some sort of protections for the patients to ensure that there will be no denial of organ transplants, should they ever be needed in the future because of this coding. Because again, the patient and doctor had no choice.", "comment_id": "SAMHSA-2023-0001-0017", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0017", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 918}, {"text": "Anything to make buprenorphine more easily accessible. It is by far the safest opioid. It's use to treat pain and opioid overdose should be studied and encouraged. It is safe enough to be dispensed over the counter to competent adults.
H B Edwards, MD
Addiction Psychiatrist
BehaveNet, LLC", "comment_id": "SAMHSA-2023-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0019", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "HOWARD", "commenter_lname": "EDWARDS", "comment_length": 306}, {"text": "I am an OTP methadone patient. I've watched as federal and state laws have provided easier access to treatment. However, this means nothing if the OTP or Methadone clinic does not adopt these rules. I have 14 years 100% compliant in my treatment but my clinic will not allow me to have more than 6 take home doses. According to Samhsa and my state law I should be getting up to 27 doses. People at other clinics with less time clean can get more takehomes than me. But because you make these changes and do not require these opioid treatment programs to follow, nothing will change. It's a shame. You just let people suffer and die and do nothing about it. I am told by the people who run the clinic that they get paid more when we have to show up in person more. So it's become about these companies money and bottom lines and not peoples lives and treatment. You all should be quite ashamed of yourselves.", "comment_id": "SAMHSA-2023-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0020", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 919}, {"text": "January 24th, 2023
Substance Abuse and Mental Health Services Administration,
Department of Health and Human Services
Re: Notice of Proposed Rulemaking on Medications for the Treatment of Opioid Use Disorder
Dear Sir or Madam,
I am submitting a comment in response to SAMHSA’s proposed rulemaking “Medications for the Treatment of Opioid Use Disorder” published in the Federal Register on December 16th, 2022.
I am a 4th year medical student with a little more than 3 months left before graduation. I recently completed my addiction psychiatry rotation and I hope to practice as a Family Medicine Physician with a strong MOUD patient panel. I strongly support the rulemaking regarding the removal of stigmatizing language and inclusion of principles of harm reduction and patient centered perspectives. However, I would like to draw your attention to a few areas where you can better realize those ideals.
While the proposed change to methadone provision rules is an improvement to the pre-COVID days, it leaves many harmful practices in place. I would like to draw from the attached article by Frank et. al. published in the Harm Reduction Journal. Here, the authors affirm the importance of take-home doses, but note that the take-home dosing guidelines are the ‘ceiling’, not the ‘floor’, as “individual clinics can adopt stricter policies if they choose”. These policies can take many different forms, many of which are not addressed by the proposed rulemaking. I have also attached the “Methadone Manifesto”, published in the American Journal of Public Health. While the whole article is worth reading, Box A details some recommended additions/changes to the rule. Notably, the elimination of negative drug tests as a requirement for take home dosing, elimination of burdensome bottle return or lock box requirements, and prohibition of accelerated tapering schedules/financial detox (often insufficient for adequate withdrawal).
It is my belief that federal policy truly rooted in patient centered perspectives and harm reduction would include these provisions. I recommend reading both attached articles to push the proposed rule to be as patient-centered as possible. The MOUD policies should be as empowering and non-stigmatizing as the proposed language changes suggest. Thank you for the opportunity to submit a comment.
Sincerely,
Jay Mainthia
", "comment_id": "SAMHSA-2023-0001-0034", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0034", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Jay", "commenter_lname": "Mainthia", "comment_length": 2510}, {"text": "My name is Jeffrey A. Singer, MD and I am a senior fellow at the Cato Institute, in the Department of Health Policy Studies. Please see my attached comment on the Proposed Rule.", "comment_id": "SAMHSA-2023-0001-0015", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0015", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Singer, Jeffrey, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Jeffrey", "commenter_lname": "Singer", "comment_length": 177}, {"text": "I am totally NOT in favor of SAMHSA adopting the Proposed Rule as is, in its entirety because it will create a huge financial hardship on the agencies that receive funding based on being CARF accredited if given one year or a non-accreditation outcome for more than a few recommendations that could be resolved within 60-90-days. Without a lot of details regarding why SAMHSA is moving into this direction, it is very difficult to really assess the pros and cons. However, one thing that I know is that agencies work hard to comply with CARF standards as well as overall service delivery to consumers and to put these stricter expectations as well as time restraints on these agencies appears to be a setup for failure. No agency is perfect and to say an agency can only have a hand full of recommendation is not reality because of the overall diversity within all agencies. It is not a one size fit all type of situation. The reason why agencies have chosen to comply with CARF standards as initially written is because we were want to provide a high level of care to our consumer based on surveyors' overall feedback within a reasonable amount of time to correct issues, etc. This is not a agency at large friendly proposal. ", "comment_id": "SAMHSA-2023-0001-0042", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0042", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": null, "commenter_lname": null, "comment_length": 1238}, {"text": "I wanted to say that I think this is a good thing for MH & addicted patients, also think that MH patient for some if not most should not be taken away our rights to certain anxiety and panic attacks meds such as benzodiazepines. When I came to South Carolina from California I had to quit on my own wt benzodiazepines because no doctor here would refill it.I would like to suggest for more groups & resources for MH patients as is almost non existent here in SC. I don’t think MH or addiction should be stigmatized anymore.!!! Thank you ", "comment_id": "SAMHSA-2023-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0027", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Rose", "commenter_lname": "Muniz", "comment_length": 551}, {"text": "To expect a treatment center to not have a singular standard (out of 1900) out of conformance seems like an unrealistic expectation. If a surveyor finds one treatment plan out of all the charts that they look at and that treatment plan was completed a week after its due date. Then that would be the one singular out of conformance that they are allowed to have for their entire survey (now they know they are only going to get a one year and they are stuck in compliance nightmares all year for every clinic they have). This regulation would force surveyors to decide if they should make any recommendations to the clinic to help them improve or decide that it is crucial for the clinic to stay open to treat patients so they must ignore any issues and just issue a perfect 100% survey at every location to ensure access to treatment for patients. It defeats the purpose of professional consultation and makes the survey process punitive.", "comment_id": "SAMHSA-2023-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0040", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Scott", "commenter_lname": "N", "comment_length": 943}]}, {"id": "DOD-2011-HA-0085", "title": "TRICARE; Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries", "context": "2020-10-22T01:28:06Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "See attached", "comment_id": "DOD-2011-HA-0085-0035", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0035", "comment_date": "2012-03-01T05:00:00Z", "comment_title": "NAABT Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "Dear Sir/Ma'am,
Please note my strong support FOR the proposed rule change.
The exclusion of maintenance therapies for addiction treatment because they are "addictive" ignores best practices in the medical treatment of substance use disorders, ties the hands of service providers, and makes recovery from chemical dependence harder for patients to achieve.
The proposed rule change would increase the effectiveness of treatment for this life-threatening and widespread illness.
Thank you,
William Aprill
LCSW-BACS, LAC, CCGC", "comment_id": "DOD-2011-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0002", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 565}, {"text": "Patients enrolled in a methadone clinic accept a high level of supervision and demonstrate a commitment to their recovery.", "comment_id": "DOD-2011-HA-0085-0017", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0017", "comment_date": "2012-02-14T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 122}, {"text": "I have submitted the comment below on letterhead using the file upload function. Here is the text.
As a researcher and clinician in the addiction field, I am writing to express my strong support for the proposed inclusion in TRICARE of coverage for methadone and buprenorphine maintenance for drug dependent individuals. Extensive research – much of it conducted with former military personnel receiving care in the Veterans Health Administration – indicates that opiate substitution therapies sharply reduce illicit drug use and risk of fatal overdose. These therapies have also been proven highly cost-effective.
At a time when a growing number of U.S. military personnel are reporting problems with prescription and non-prescription opioids, the addition of this benefit to TRICARE is critically important. For the regulatory change to be maximally beneficial to the health of our military personnel and their families, it should be coupled with extensive outreach to TRICARE providers to make them aware of the new insurance benefit.
Thank you for proposing this major step forward for the TRICARE program.
", "comment_id": "DOD-2011-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0003", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 1284}, {"text": "The use of opioid maintenance therapy on a long term basis has not been proven to improve functionality or reduce mortality or relapse. Most tests of the efficacy of opioid treatment therapy have been conducted on a short term basis. Research has shown that on a short term basis, those given methadone or buprenorphine reduce their use of other opioids, but only for as long as they are on the drugs. Many continue to use other substances such as alcohol, and continue to be at risk of overdose. Methadone overdoses have increased 400% from 2004-2008. Harm reduction philosophy (upon which use of an addictive substance is sanctioned to treat dependence on another substance) is an enabling philosophy that continues addiction, rather than treat it. As long as the person remains dependent on an abusable substance, he or she can never realize his/her potential as a whole, infinite spiritual being. It is a disrespectful and demeaning approach to the plight of the addict and keeps him/her shackled to the progression of this dangerous mental disorder and foreshortens his/her life. The use of chronic opioid therapy for chronic noncancer pain has created this epidemic of opioid dependent persons and yet so little is being done to stop the production of opioid dependent persons and much is being propagated about the "evidence-based" need for the use of more opioids to treat the problem. This is insane!", "comment_id": "DOD-2011-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0004", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 1419}, {"text": "The proposed change reflects the best evidence-based practice in the treatment of opioid dependence. I fully support this change in the applicable regulation.
I speak from the experience of prescribing buprenorphine (Suboxone/Subutex) since 2004 in the treatment of opioid dependence in the context of a comprehensive treatment program by our agency of which I am the medical director. I also support Opioid Treatment Programs that prescribe methadone in the treatment of opioid dependence along with counseling.
I am Board-certified in Internal Medicine and Addiction Medicine and have been working in the field of addiction medicine since 1989.", "comment_id": "DOD-2011-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0007", "comment_date": "2012-01-10T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 666}, {"text": "Dear Sir or Madam,
On behalf of the Ohio Department of Alcohol and Drug Addiction Services (ODADAS) Clinical Roundtable Committee, I am pleased to submit the following comments on the proposed rule related to TRICARE benefits, “Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (Document ID DOD-2011-HA-0085-0001).”
The Clinical Roundtable -- comprised of six senior clinicians and supervisors with established expertise in the clinical treatment of addictive disorders, drawn from ODADAS-certified treatment agencies from across the state -- strongly supports extending the benefit so that maintenance regimens of Medicated-Assisted Treatment (MAT) will be covered by TriCare. Scientific literature supports provision of MAT on an ongoing basis as being far more efficacious than alternative approaches, including detoxification-only or short-term utilization of MAT. Furthermore, several Roundtable members are familiar with the use of opioid replacement therapies (MAT) on an ongoing basis in their own agencies and have found it to be effective and practical.
The Clinical Roundtable also recommends addressing barriers that limit access to other clinical services (counseling, case management) within the TRICARE system. MAT is considerably more likely to be effective when combined with counseling and case management services; however, community agencies with the highest level of expertise in providing such services have found that they cannot receive reimbursement through TRICARE. While the Clinical Roundtable fully supports and recommends immediate action on the MAT proposal, there is a strong consensus that further access to addiction-related services needs to be addressed as well.
Thank you for this opportunity to provide comment. Please do not hesitate to call or email if I can be of additional assistance.
Sincerely,
Orman Hall, Director
ODADAS
", "comment_id": "DOD-2011-HA-0085-0026", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0026", "comment_date": "2012-02-27T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2019}, {"text": "See attached file(s)", "comment_id": "DOD-2011-HA-0085-0020", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0020", "comment_date": "2012-02-23T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached.", "comment_id": "DOD-2011-HA-0085-0033", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0033", "comment_date": "2012-02-28T05:00:00Z", "comment_title": "CSAC Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 13}, {"text": "On behalf of NAADAC, the Association for Addiction Professionals, which represents the professional interests of more than 75,000 addiction counselors, educators and other addiction-focused health care professionals in the United States, Canada and abroad, we thank you for this opportunity to submit comments to the Department of Defense regarding the TRICARE: Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (RIN 0720–AB54).
NAADAC applauds the proposed change in TRICARE policy regarding the use of therapeutic drugs in maintenance treatments for substance dependence. There is a wealth of medical evidence available that supports the belief that medication-assisted treatments are safe and highly effective. The extension of benefits to include these treatments increases the quality of treatment options available to TRICARE beneficiaries.
The use of medication-assisted treatments is not for everyone. Thus, we would recommend that included in the rule is a requirement that all individuals undergo an assessment prior to starting any medication-assisted treatment to ensure that they are receiving the appropriate care. We also recommend that there be a requirement that anyone receiving medication-assisted treatments also take part in a comprehensive psychosocial treatment program to be administered concurrently. We believe these added components will serve to prevent further dependence by assisting counselors in obtaining an ongoing assessment of the treatment.
While NAADAC does not have an official written statement outlining support for medicated assisted treatment for individuals with addiction problems, since 2005 we have been active in the development of training experiences surrounding this topic for addiction treatment professionals. Through a training program entitled “NAADAC’s Life Long Learning Series” five different training experiences have been developed and trained to ", "comment_id": "DOD-2011-HA-0085-0015", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0015", "comment_date": "2012-02-14T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2048}]}, {"id": "FDA-2017-P-6307", "title": "Request that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes pharmaceuticals LP (ANDA# A074769) as reference standard (RS) for the subject drug product to conduct in vivo bioequivalence studies.", "context": "2019-03-14T16:22:32Z", "purpose": "Nonrulemaking", "keywords": ["CITIZEN PETITION", "CDER", "Aurolife Pharma LLC", "Reference listed drug (MSCONTIN", "NDA # 019516)", "Purdue Pharma LP", "discontinued", "MS CONTIN", "Referencing Approved Drug Products in ANDA", "Morphine Sulfate Extended Release Tablets", "100 mg", "Rhodes Pharmaceuticals LP (ANDA# A074769)"], "comments": [{"text": "Goals for Chronic Pain Patients to receive adequate pain relief;
* For correct misinformation online and in Media about chronic pain patients and opioid therapy be amended and corrected!
* * institute a Chronic Pain Patients "Bill Of Rights".
-We all have a right to relief from our debilitating pain and discomfort.
* United Nations policy states PAIN MANAGEMENT IS A FUNDAMENTAL HUMAN RIGHT, under treatment or not treating is a crime against humanity and considered torture! That is what is being done to chronic pain patients all over this country right now! I being one of them as I am experiencing abandonment of care from my doctor. who has refused to treat me. Thus, I am in a very precarious state right now! I looking for a doctor. However, all pain management specialist are booked for at least a four month window! My pain is chronic 24/7, 365 days a year. I can't wait that four months. I do not want to end up as a statistic on the suicide list!
Since the narrative of the "opioid epidemic" has taken hold, some/ many doctors are refusing pain relief, in fear of retribution, imprisonment or loss of livelihood!
Many hospitals are implementing after surgery a spinal block and Tylenol, many patients are dying attributing it to cardiac arrest which is not the case!
#2 Collateral damage Because of the innumerable, severe, and long lasting effects of constant pain, I believe that treatment for chronic pain is a human right.
It impairs every part of a persons entire life, career, family, mind, body, spirit and soul. From financial hardships due to being unable to work and the family issues as we cannot be the parents, grandparents partners that we would have and should be.
Many chronic pain patients are hypo metabolizers or hyper-metabolizer ... I suffer with malabsorption I had a surgically inserted port in my chest.
I had tpn pumped into to my body for 12 to 24 hours a day for 8 + years.
I could not absorb the proteins in my food this is the way I sustained my life. It makes sense since food did not absorb either did my medication that is why I had to have higher doses For it to work.
We are not a one-size-fits-all society.
This creates, a lot of collateral damage to the family because we are not able to function in a fashion that our family needs us to ! It also starts to deteriorate our children's mindset as they are continually worried as to our health, expectancy of life/ longevity of life !
I know this first-hand has changed who my four children could have been ! It put too much weight on them while trying to go through school and life in general !
Because of all the family issues in addition to other health issues like brain and organ damage from lack of sleep, medications, and the rewiring of your brain from constant stress. Air condition, heating our sensory capabilities are all screwed up we need to help chronic pain patients get better treatment, education of the public on the complexities of chronic pain, lobby the government to make changes that will benefit chronic pain patients, and to foster a better understanding of chronic pain patients struggles day in Day Out with daily life.
After reading so many frustrating stories of chronic pain patients dealings with the healthcare industry, I decided to create a foundation that would serve the needs of chronic pain patients everywhere. By first educating the public on what chronic pain really is, how it affects us and our families, and what is missing in our treatment. Then I would like to focus on changing how government views chronic pain patients and writes guidelines and legislation that affects them.
For those of us who suffer day in and day out 24/7, 365 days a year Relentless, cruel, aching, affliction, agony, burn, catch, convulsive, cramping, crick, discomfort, distressing, fever, gripping, hurting, illness, injury, irritation, laceration, malady, misery, pang, paroxysm, prickling, sickness, smarting, soreness, spasm, stinging, stitching, straining, tenderness, thro, tingling , tormentous, torturous, troubling, twinging, wounding always present, horrendous, debilitating pain sharp, exacerbating,
There is a need in the chronic pain community and it is not being addressed, please we need to reduce the suffering as much as possible, of people suffering from chronic pain.
Suicidedue2pain
Malabsorbtion -TPN
Music therapy
Massage
Behavior therapy
Physical therapy
Biofeedback
Acupuncture etc
Three options - reform of opioid guidelines
3. Campaign/Organizational Goal and Key Objectives
Educating the public about chronic pain and how it affects chronic pain patients.
-Fight preconceived notions on pain medication and those who need it.
-What is missing from treatment of chronic pain?
-Changing governmental views
-Get new guidelines on pain medication created for chronic pain sufferers.
-Explain how the war on opioids is killing chronic pain sufferers!", "comment_id": "FDA-2017-P-6307-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0006", "comment_date": "2018-05-01T04:00:00Z", "comment_title": "Comment from CATHY KEAN", "commenter_fname": null, "commenter_lname": null, "comment_length": 5172}, {"text": "Dear Readers,
I am not certain how to write this letter, but I feel I must respond and comment on these regulations and have a voice in federal making of decisions.
I have been in chronic pain since 1984. In all these years since a respiratory infection ended with widespread body pain, I have not had one day without pain. The original disease has increased from musculoskeletal to inflammatory and degenerative arthritis throughout all my joints. Every X-ray is filled with arthritis and bone spurs, even bone in locations bone should not be. An MRI of my spine sent me to a neurosurgeon who said the only surgery that might work would never permit me to bend over again.
I take both diazepam and hydrocodone, in addition to medications you might not consider opioids or narcotics. These two are not high dosage, but they have worked and allowed me an active life. Daily I take care of horses, my own home, animals, and I work. I work as a writer and have had 16 books published while taking these medications. My main publisher has been WW Norton in NY. And for poetry, I have used a smaller, independent press. I also travel frequently to read my work, do workshops, and lecture on a variety of topics.
This is with my medications.
Without them, I am unable to get out of bed. I have had screams that are involuntary. I cannot bend or do any movement or work. My hands do not work, will not type, nor can I walk without severe pain. Without these medications, I will have no life, or
at least not one worth living.
The Dr. has changed. Even he has fear. He does not wish to prescribe medications like the ones I take, swears they would kill anyone else, all the exact same stories as the numerous other pain patients say they have heard. I feel sorry for those of us in pain, but I also feel sorry for those in the medical profession who are unable to really help their patients.
Many pain patients have been committing suicide rather than living a life suffering. These deaths are worse than the ones of addicts who are shooting up because they are created by the government's regulations and fear tactics. They are going after the wrong people.
Most of us are taking our meds at the right times, not asking for larger doses, and are responsible with our meds. We do not misuse our medicines. For us they are not addictive drugs, but healing agents that allow us to live full lives.
Please consider this in your Regulations. We do want to live. We do not overdose. We are not the criminals. We want to be free from pain, as anyone else also would.
Sincerely,
Linda Hogan
Professor Emerita
U of Colorado, Boulder
www.lindahoganwriter.com
", "comment_id": "FDA-2017-P-6307-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0003", "comment_date": "2018-03-28T04:00:00Z", "comment_title": "Comment from Linda Hogan", "commenter_fname": null, "commenter_lname": null, "comment_length": 2763}, {"text": "I'd like to start out by saying I'm a 39 yr old mother of 6. And have had chronic pain for over half my life.
I was 11 yrs old when I first started having back pain and then went on to knee pain. I was cative throughout school I was involved in track n field, volleyball, cheerleading & basketball. I had to wear 2 knee braces and was on a very high does of anti-inflammatory prescription from my knee doctor at age 12. After giving birth to my 3rd child at age 20 I had my 1st knee surgery, every year after that 1st surgery i had knee surgery after another for 5 years... I had been sent to neurologist's and physical therapy chiropractor and differant doctor's ect.
Finally at age 28 i found my dr and he referred me to a spine specialist and he diagnosed me with Schumann's disease which is very painful my spine was 69% curved on top and 69% curved on the bottom. They did surgery October15th 2010 and it was a very long recovery.
I've been on Percocet for 7 yrs and don't abuse it. I can't even get out of bed, walk or do basic self care without it. I've seen what drug addiction has done to our community and people i love.
But dont punish us that need our medication to live our basic daily lives.", "comment_id": "FDA-2017-P-6307-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0005", "comment_date": "2018-04-17T04:00:00Z", "comment_title": "Comment from Miranda MuellerMcClure", "commenter_fname": null, "commenter_lname": null, "comment_length": 1261}]}, {"id": "FDA-2021-P-0514", "title": "Requests that the FDA declare that Naloxone HC1 Nasal Spray, 8 mg/Spray, is suitable for submission as an ANDA and to introduce a new 8 mg/Spray metered spray strength for prescription use", "context": "2022-04-25T11:42:15Z", "purpose": "Nonrulemaking", "keywords": ["Suitability Petition", "CDER", "HYMAN, PHELPS & MCNAMARA, P.C.", "for prescription use", "metered spray strength", "introduce a new 8 mg/Spray", "Approved Drug Products with", "Orange Book", "Therapeutic Equivalence Evaluations", "Reference Listed Drug (RLD)", "as an ANDA", "Abbreviated New Drug Application (ANDA)", "is suitable for submission", "8 mg/Spray", "declare that Naloxone HCl Nasal Spray", "OPEN"], "comments": [{"text": "N/A", "comment_id": "FDA-2021-P-0514-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0007", "comment_date": "2022-04-25T04:00:00Z", "comment_title": "Comment from Foley & Lardner, LLP", "commenter_fname": null, "commenter_lname": null, "comment_length": 3}, {"text": "On behalf of Hikma Pharmaceuticals USA, Inc. (“Hikma”), the undersigned submits the following comments pursuant to 21 C.F.R. § 10.30(d) opposing the above-referenced suitability petition.", "comment_id": "FDA-2021-P-0514-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0006", "comment_date": "2021-08-20T04:00:00Z", "comment_title": "Comment from Lassman Law+Policy", "commenter_fname": null, "commenter_lname": null, "comment_length": 204}]}, {"id": "FDA-2005-P-0191", "title": "For patient safety and public health considerations, recommending scheduling tramadol under the Controlled Substances Act", "context": "2021-09-01T01:01:17Z", "purpose": "Nonrulemaking", "keywords": ["substances", "controlled", "tramadol", "fda", "scheduling", "drugs", "food", "CDER"], "comments": [{"text": "See attachment", "comment_id": "FDA-2005-P-0191-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0191-0005", "comment_date": "2016-03-22T04:00:00Z", "comment_title": "Comment from Ortho-McNeil, Inc. (Hyman, Phelps & McNamara)", "commenter_fname": null, "commenter_lname": null, "comment_length": 14}]}, {"id": "FDA-2016-D-0785", "title": "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products", "context": "2017-11-22T10:26:14Z", "purpose": "Nonrulemaking", "keywords": ["2015-181", "General Principles for Evaluating", "Abuse Deterrence of Generic Solid Oral", "Opioid Drugs Products", "2016-932"], "comments": [{"text": "
My name is Jennifer Ford, and I have fibromyalgia. Including chronic pain, chronic fatigue, depression, anxiety, degenerative disc disease, COPD, just to name a few. I am able to barely maintain some level of a normal life with pain levels of a 5-6 on a good day. This is with the use of three hydrocodone a day. No more, no less. I receive a prescription of 90 per month. That's 3 a day, for 30 days. Take that away from me, and I have no idea what I'll do. Please leave chronic pain patients alone. We are patients, not addicts.
13", "comment_id": "FDA-2016-D-0785-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0008", "comment_date": "2016-05-09T04:00:00Z", "comment_title": "Comment from Jennifer Ford", "commenter_fname": null, "commenter_lname": null, "comment_length": 556}, {"text": "No more opioid guidelines that hurt the Chronic Pain community. My doctors are refusing medications they themselves put me on. We matter, the quality of our lives matter and our voices need to be listened to. Addiction within our community is very rare. ", "comment_id": "FDA-2016-D-0785-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0016", "comment_date": "2016-05-26T04:00:00Z", "comment_title": "Comment from C, Hope For The Hopeless Chronic Pain Issue's and Awareness", "commenter_fname": null, "commenter_lname": null, "comment_length": 254}, {"text": "I have taken opioids on and off for 30 years responsibly and safely. I have adhesive arachnoiditis. Without these meds many chronic pain patients will have no quality of life. What the government is doing is outrageous. You can buy codeine over the counter in Canada. It is not a gateway drug to heroin. Although the money grubbing addiction industry would like you to think so. The problem is heroin coming into the country from Mexico and China. If you want to fix the drug problem fix that. A new study shows that opioid overdoses peaked in 2012. Even if you take opioids off the market you will still have addicts acquiring it on the streets. You are throwing the baby out with the bath water. Patients who suffer everyday with excruciating pain rely on these medications to bring the pain down to a tolerable level. We take our medications responsibly. Any physician who says to take oxycodone off the market has no compassion. There is a place for opioids in medicine when the are prescribed responsibly. Pain patients are just getting warmed up! If you think we're going to tolerate this treatment you are wrong! ", "comment_id": "FDA-2016-D-0785-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0025", "comment_date": "2016-06-06T04:00:00Z", "comment_title": "Comment from Katherine Owen", "commenter_fname": null, "commenter_lname": null, "comment_length": 1124}, {"text": "I my name is James I have a chronic pain disease called rsd or crps. I use some of these drugs to control my pain and help me get through my day. There are many of us in the same position as I am. If you put uncentsable regulations on this we are going to be the ones that suffer from this for others stupidity pleases stop and think about the people that need this to get though our days and nights and to be able to spend time with our families. There are other ways to weed out the people that are abouseing theses drugs. I know we as the people of this country don't really matter to you people on any of these maters, but maybe just maybe for once in your time in office you will do the right thing and help the people that put you there. If you all had to spend one day in any of our shose you would understand where we are coming from. PLEASE PLEASE STOP AND THINK BEFORE YOU TAKE ANY ACTION ON THIS. If you were one of use you would be doing all you can't to take a different position on any of this.", "comment_id": "FDA-2016-D-0785-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0043", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from James Boles", "commenter_fname": null, "commenter_lname": null, "comment_length": 1016}, {"text": "Dr. Glapinski, I am a chronic pain sufferer and one who is DEPENDENT on oxycodone for a QUALITY OF LIFE. In reading your comment, you are aware that chronic pain pts depend on opiods and are in agreement, and then you turn around and say ban oxycodone. Just because you are against it for what ever reason, there are MANY LEGITIMATE chronic pain pts who retain a QUALITY OF LIFE by taking oxycodone. I have tried nearly all of them over the course of ten years. Opiods were my last resort, first came years of physical therapy, massage, chiro, accupuncture, epidurals, discographies, OTC AND NSAIDS that tore my stomach and liver up, facet injections, trigger point injections, nerve blocks, steriods, nerves burned, TENS, and two FAILED spinal fusions that left me with severe nerve damage. Oxycodone happens to be the one medication that agrees with me and takes my unbearable pain to a tolerable level, when I was on the right dose. Because of all these INHUMANE restrictions by the CDC, FDA, DEA and the government, Legitimate pain ots are having their once stable dose lowered to INEFFECTIVE DOSES or totally stripped of them, leaving many in agony and severe withdrawal. Shame on any of you doctors who abandon their patients. We are suffering from incurable conditions that cause severe pain, I beg God to take me daily. Would you do that to your Mom? Could you sit back and watch your loved one be at war with their body, stabbing, burning, crushing, piercing, pains, the emotional and mental toll it takes on a person, If your loved one got relief by taking opiods, would you want them to have some QUALITY OF LIFE and enjoy what they can or strip them of the only treatment they gave them some relief, force them to remain bedridden, shut off from society, many are turning to suicide to escape the pain. You doctors took an oath to do no harm. I get the DEA is targeting all our drs, there is way more harm being done to the chronically ill, we are being FORCED to suffer, to exist in hell, All the doctors thruout this country who believe in helping the suffering, especially when we've tried the alternative therapies OUR BODIES could take, it's physically, mentally and emotionally exhausting fighting this battle, then the stigma that is thrown on our backs, shame on all of you dra for not standing alongside the suffering. Perhaps if you treated each person as if you would your mom, maybe there would be compassion and empathy brought back into the dr/patient relationship. I see and hear nothing but NEGLECT, ABUSE, DEGRADING, DISCRIMINATION AGAINST LEGITIMATE PAIN PTS. Another fact is there is no opiod epidemic. The CDC used false data, even admitted to MISCLASSIFYING MANY heroin and fentanyl deaths, doubling and tripling one persons death, legit pain pts who committed suicide were listed an overdose, if alcohol or any other illicit drugs played a part the CDC looked the other way, they created mass hysteria that the media and government took off with, constantly demonizing a chronic pain pts LIFE SAVING MEDICATIONS. The CDC created FALSIFIED STATISTICS MADE TO FIT THE GOVERNMENTS ADDICTION DRIVEN AGENDA. Chronic pain pts are LAW ABIDING citizens who have DEBILITATING INCURABLE CONDITIONS, who have tried whatever was put in front of us by the medical community to get relief. We dont BREAK THE LAW, WE DONT ABUSE, SELL, SHARE, SNORT, OR ANYTHING ELSE TO OUR LIFE SAVING MEDS. WE ARE SICK FOR GOD SAKE. We are treated HORRIBLY by the medical community, treated like everyone is a pill seeking junkie, addict, and criminals. I am so fed up with paying the high price with my health and overall well being because of those who CHOOSE TO ABUSE, people who CHOOSE TO BREAK THE LAW, WHO CHOOSE TO POP DRUGS, OR GET DRUNK OFF ALCOHOL, PEOPLE WHO CHOOSE TO DESTROY THEIR BODIES, Addicts are given all kinds of opportunities to get help, all kinds of doors open for them, hell even the government passes out clean needles to shoot their drug of choice up with and safe houses to go get high and shoot up. When an addict, someone who CHOOSES TO ABUSE , fails a drug test during treatment they are given chance after chance, they aren't kicked out and turned away, A LEGITIMATE chronic intractable pain pts are turned away, judged and labeled as addicts, pts who have been with their drs for years and were on the same stable dose that worked for them are having meds reduced or taken away thru no fault of our own, for following the rules, getting drug tested monthly, shamed at the pharmacy, if you even find a pharmacy to fill your LEGAL lifesaving medication. Nearly all chronic pain pts have suffered for years and have years of medical records documenting their DEBILITATING INCURABLE conditions, usually has had many MRI's scans, tests, etc.These debilitating conditions only continue to worsen over time, so why are we decreasing legit pain pts meds when the doses really should be increased. How would it make you feel if your own mother were so poorly neglected!?", "comment_id": "FDA-2016-D-0785-0056", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0056", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Pam Molnar", "commenter_fname": null, "commenter_lname": null, "comment_length": 5013}, {"text": "1.Although the theme of the guidance seems, as expected, to proof that tested generic formulation (T) is not inferior to an approved AD reference formulation (R) and some studies were designed to test T against R directly, e.g. syringeability, introducing the control formulation (C) in some studies, e.g. extractability, created some confusion between qualifying an original brand name AD formulation (R) and a generic. We believe that, for generics, T should be tested directly against R, with no need for a third formulation (control), unless one route of abuse was not considered/listed on the R label.
2.There is no clarity if in-vitro testing need to be done or at least verified by a third party laboratory to avoid manufacturer's bias which we have noticed as a third party lab.
3.The draft guidance, as well as the previously approved AD guidance, focus on opioids but we believe that it should cover, also, non-opioids of potential abuse, e.g. amphetamines or molecules that can be precursor for recreational drugs, e.g. pseudoephedrine.
4.Smoking simulation study listed 233C as a definite temperature for heating but from our experience, this temp was not good to volatilize morphine or oxycodone and for which we needed to optimize the heating conditions. Not sure why the paper ignition temperature was used to set up this figure noting that different heating techniques including direct heating a drug on a piece of aluminum foil or putting a drug directly on ignited charcoal, e.g. "hookah", have been used. We believe that, smoking simulation studies should be optimized first using pure compounds and select the most effective heating condition/temp to test an AD formulation.
5.The guidance did not mention core separation as a part of physical manipulation for formulations with API is enclosed in a core within a hard shell.
6.The guidance did not mention saline solution for extractability or syringeability where it's a potential solvent that can be easily obtained by a drug abuser and safely injected. In this regard, for generics, we believe that all or representative solvents which were used to qualify an R should be used for T.
7.For particle size distribution following physical manipulation, 500 micron was used as a cut-off; does this mean no particle size characterization is needed below 500 micron?
8.Free base isolation; 233C for 2-15 minutes was listed to dry up a precipitated base without a rationale. From our experience, different temperatures and/or different heating times can be needed and noting that 233C was already suggested for smoking simulation, heating some compounds at this temp for 15 minutes may cause significant loss.
9.Liquid-liquid extraction was not listed but from our experience, after proper optimization, it was an efficient tool to isolate some opioids.
10.The guidance did not handle AD formulation which depend on conjugation of an active moiety to a pharmacologically inert side chain which needs to be cleaved inside the human body for slow release of the active molecule.
11.The guidance suggest 28 to 18 for syringeability and we suggest to consider either 28 or 27 as the latter is common and such small bore size should not make a difference compared to 28.
", "comment_id": "FDA-2016-D-0785-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0003", "comment_date": "2016-04-29T04:00:00Z", "comment_title": "Comment from Abdel Halim", "commenter_fname": null, "commenter_lname": null, "comment_length": 3791}, {"text": "I don't understand why you think that going after physicians & their patients, specifically chronic pain patients is going to somehow make this heroin epidemic lessen or disappear. I am a woman who was born with severe JRA at 15 months old, have had several surgeries, & other diagnoses along the way........Fibromyalgia, CFS, seemingly untreatable bi-lateral hip bursitis, constant back spasms, & the list goes on. I have for over 10 years been under the care of my wonderful rheumatologist & have ALWAYS listened to her, followed all directions, & more importantly NEVER, EVER given her reason to think I was doing anything otherwise. I am a perfect patient. My pain meds make my life liveable & when I say that....I mean my kind of liveable. I am permanently disabled so nothing is perfect, BUT being able to make dinner for my family at night & do some light housekeeping is only because of my pain meds. And now you want to make it harder? For what? Why? To eliminate what you think is the reason for heroin? Look around, do some more research. We have above pharmacy grade opiates coming across our borders & drug dealers are selling it to addicts. That's NOT us. Under 5% of the chronic pain community become addicts. Do we depend on our meds? Yes, but for living, for function, & so we are not bedridden. We aren't getting "high", we are getting some relief. There's a HUGE difference between physical dependence & psychological dependence. We are not in the latter group. Diabetics rely on their insulin, we rely on pain management. There is really no difference. Every medication comes with risks. You overdose on an over the counter medication too. It's called personal responsibility & because some don't practice that, you make ALL pay? You have already made getting our meds tougher with changing the scheduling class, breathing down the necks of our doctors, making them so scared to actually treat their patients now, pain contracts, random urine tests, pill counts, etc, etc...... What else do you want?? After all those things were implemented NOTHING changed with the addicts. In fact in one city next to me the drug use & overdoses have actually doubled since then! Seems like you are barking up the wrong tree. I get my meds, keep them in a fire safe locked box & practice good medication safety, but now I feel that at any moment my rheumatologist could pull the rug out from under me because of fear, or because you come up with some other crazy rule/regulation. She has already stated that it is out of her hands & she actually told me she will not longer prescribe pain meds to new patients, only the ones that are already on them. Really? Find another way to control this epidemic, because last I checked drug addicts don't hang out at rheumatologist, neurologist, or oncologists offices. Go after the drug dealers & the border. Please leave those of us that do nothing wrong alone. Will you release the suicide rates in the chronic pain community when they go off the charts? Because I have already read of SO many, & in many cases it happened because a physician got scared & just stopped their meds cold turkey, which is incredibly dangerous & in my opinion medically unethical. Those people end up in the ER & are treated like subhuman beings. Wow, that's really good medical care. Let the rheumatologists, neurologists, oncologists, & pain clinic physicians do their job. None of us want to be on these meds, but we have come to them because we have tried everything else. I have done physical therapy several times & got cortisone shots every 3 months for over 4 years. Give me a break! Until the scientists & researchers come out with some other medication and/or treatment that works as good as opiates, leave us alone. There are also so many of us that cannot take the conventional medications for our diseases because we have really horrible side effects, & opiates end up being our safest most effective treatment. Why punish the innocent people just trying to live a semi-normal life? When are you going to stop punishing the wrong group of people? Why should we pay for others bad decisions? I am disgusted & I don't deserve to be treated like this. The way pharmacists look at us, treat us, & even lie about how they "cannot" fill our prescriptions is beyond ridiculous. Thankfully I have a wonderful pharmacy. I ran a chronic pain support group on line for over 4 years & I heard the horror stories. They have been so bad I was forced to stop running the group.....between the stress & my own illness, well.....I just felt I had nothing left to give my members. Everything looks dim for them, & that's a sad state of affairs for people that have no choice, who were born with horribly painful diseases & illnesses. They aren't addicts, they are patients. Shame on the medical community, the government, the DEA, & the CDC. You aren't doing your job, you are just creating another problem. Looks good on paper maybe? Horrible!", "comment_id": "FDA-2016-D-0785-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0023", "comment_date": "2016-06-06T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5186}, {"text": "We are real chronic pain patients with real pain...........not drug addicts!", "comment_id": "FDA-2016-D-0785-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0071", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 76}, {"text": "The regulations against opiate pain medicine has been devastating to my family, to people I care about and to myself personally. I am not a pain patient or user of opiates but my husband who has been disabled for 20 years is a chronic pain patient. These regulations put him through on-going trauma, and pain. Our basic human rights are violated. We are not allowed to live where we want to, or in the state we want to, because we are prisoners to proximity to a doctor who will prescribe the essential medicine. To get this medicine he must submit to urine tests which violate his 5th amendment rights. Law enforcement doesn't belong in doctor's offices and hospitals! Basic human rights are disregarded in this failed "War on Drugs" created by Nixon for racist and evil objectives. Stop restricting medicines! Stop your "war" against the American people! Leave pain patients alone. Stop blaming suicides on pain medicine and look at the patients in chronic pain who are told that their only source of relief has been outlawed! Stop criminalizing self-medication. You are not supposed to control other people's choices with their own bodies. Citizens of the United States are back to having to reclaim their rights to self ownership.", "comment_id": "FDA-2016-D-0785-0078", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0078", "comment_date": "2016-07-07T04:00:00Z", "comment_title": "Comment from Heather Martin", "commenter_fname": null, "commenter_lname": null, "comment_length": 1267}, {"text": "Why are you not going after other patients medications? Start taking medications for those suffering from all other conditions too! SMH!! ", "comment_id": "FDA-2016-D-0785-0033", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0033", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 141}]}]
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