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S. HRG. 111–611 

THE WAR ON DRUGS 

MEETS THE WAR ON PAIN: NURSING HOME 

PATIENTS CAUGHT IN THE CROSSFIRE 

LISTENING SESSION 

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

WASHINGTON, DC 

MARCH 24, 2010 

Serial No. 111–16 

Printed for the use of the Special Committee on Aging 

( 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

BILL NELSON, Florida 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

MARK UDALL, Colorado 

KIRSTEN GILLIBRAND, New York 

MICHAEL BENNET, Colorado 

ARLEN SPECTER, Pennsylvania 

AL FRANKEN, Minnesota 

BOB CORKER, Tennessee 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

GEORGE LeMIEUX, FLORIDA 

ORRIN HATCH, Utah 

SAM BROWNBACK, Kansas 

LINDSEY GRAHAM, South Carolina 

SAXBY CHAMBLISS, Georgia 

DEBRA WHITMAN, Majority Staff Director 

MICHAEL BASSETT, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Herb Kohl ............................................................. 1 

PANEL I 

Statement of Michael Schanke, Administrator, Oakridge Gardens Nursing 

Center, Menasha, WI; on behalf of American Health Care Association and 

National Center for Assisted Living ................................................................... 3 

Statement of Robert Warnock, D.PH., Vice President of Pharmacy Services, 

Golden Living, Fort Smith, AZ ........................................................................... 15 

Statement of Cheryl Phillips, M.D., President American Geriatrics Society, 

New York, NY ...................................................................................................... 26 

Statement of Ross Brickley, RPH, President, Continuing Care RX, INC., 

Raleigh, NC; on behalf of American Society of Consultant Pharmacists 

and the Quality Care Coalition For Patients in Pain ....................................... 35 

PANEL II 

Statement of Joseph Rannazzisi, Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement Administration, U.S. Department of 

Justice, Washington, DC ..................................................................................... 64 

Statement of Carmen Catizone, DPH, Executive Director, National Association of Boards of Pharmacy, Mount Prospect, IL .............................................. 74 

APPENDIX 

Mr. Schanke’s Responses to Senator Brownback’s Questions .............................. 83 

Mr. Warnock’s Responses to Senator Brownback’s Questions ............................. 83 

Ms. Phillip’s Responses to Senator Brownback’s Questions ................................ 84 

Mr. Brickley’s Responses to Senator Brownback’s Questions .............................. 84 

Mr. Rannazzisi Responses to Senator Brownback’s Questions ............................ 85 

Mr. Catizone’s Responses to Senator Brownback’s Questions ............................. 87 

Statement submitted from Fran Savard of AOPHA, Columbus, OH .................. 88 

Statement submitted by Ron Fisher, MD .............................................................. 89 

Statement submitted on behalf of the American Medical Directors Association 

(amda) ................................................................................................................... 90 

Statement submitted by the American Association of Homes and Services 

for the Aging (aahsa) ........................................................................................... 104 

Letters and information from the Members of Seniors Aid NH, Concord, 

NH ......................................................................................................................... 118

Statement of the National Community Pharmacists Association ....................... 121 

Statement submitted by Denise Barter, RPh, MBA, FASCP ............................... 125 

Testimony from the Pharmacy Society of Wisconsin ............................................ 127 

Letter from Kristie Roller-Bauknecht, Director of Pharmacy Services, Sauk 

City, WI ................................................................................................................. 131 

(III) 

(1) 

THE WAR ON DRUGS MEETS THE WAR ON 

PAIN: NURSING HOME PATIENTS CAUGHT 

IN THE CROSSFIRE 

WEDNESDAY, MARCH 24, 2010 

U.S. SENATE, 

SPECIAL COMMITTEE ON AGING, 

Washington, DC. 

The Committee met, pursuant to notice, at 2:05 p.m. in room 

SD–106, Dirksen Senate Office Building, Hon. Herb Kohl (chairman of the committee) presiding. 

Present: Senator Kohl. 

OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN 

The CHAIRMAN. Thank you so much for being here today. 

This afternoon, we’ll examine the dispensing of pain medication 

in nursing homes across our country, a very serious issue that impacts the daily well-being and comfort of millions of elderly Americans. 

It’s safe to say that most laws are created to prevent suffering. 

In the case of the U.S. Drug Enforcement Administration’s recent 

crackdown of nursing homes, it appears that the law exacerbates 

it. The hours it may take for a nursing home to fully comply with 

DEA regulations can feel like an eternity to an elderly nursing 

home resident who’s waiting for relief from excruciating pain. Our 

hope for today’s session is that we can find a better strategy that 

allows the DEA to do its job and enables infirmed nursing home 

residents to receive their medication in an expedient way. 

According to several of our panelists and other industry sources, 

nursing homes and long-term care facilities have found themselves 

either heightened—under heightened scrutiny from the DEA, a 

Federal agency with the vital job of regulating the use and sales 

of controlled substances. 

The DEA’s initiatives often save lives and do make a positive impact. The problem is that, while the DEA claims that they are 

working to keep prescription drugs out of the wrong hands, in reality they are causing widespread confusion, with the result of 

interruption and delays in timely access to pain medication for vulnerable seniors. 

We’ve heard from many providers in my home State of Wisconsin 

who say that they are faced with the impossible choice of following 

the letter of the law and caring for sick residents in the best way 

they know how. 

2 

While I support the DEA’s national drug diversion strategy, 

which prevents prescribed medications from reaching those who 

would abuse them, it seems that their efforts are misplaced here, 

with sick seniors paying the price. 

Today, we’ll hear about pain management for the elderly, the 

role of nurses in ordering and administering medication, and proposals for possible changes to the regulatory scheme that governs 

long-term care facilities and pharmacies. We’ll hear from the DEA, 

in order to gain a better understanding of what their intentions 

are. 

I understand that unanimous consent was not given this morning for committees to hold regularly scheduled hearings and meetings today. We appreciate that some of you have come a long way 

at your own expense to have your voices heard on this important 

issue. For that reason, although our committee will not be holding 

a formal hearing this afternoon, this will be regarded as a listening 

session, so that we can get and understand your positions on this 

issue. 

We’ll now turn to our first panel. Our first witness this afternoon 

will be Michael Schanke. Mr. Schanke is the Owner of Oakridge 

Gardens Nursing Home Center, and President of Gardenview and 

the Gardens of Fountain Way Assisted Living in Menasha, WI. Mr. 

Schanke is responsible for all aspects of daily operations at the 

Oakridge Gardens Nursing Home and these two assisted living facilities. 

He will be followed by Robert Warnock. He is Vice President of 

pharmacy services for Golden Living, a skilled nursing facility 

chain based in Fort Smith, AR. He’s a certified geriatric pharmacist. Golden Living cares for more than 60,000 nursing home 

and assisted living facility residents every day across our country 

in 37 States. 

Our next witness will be Dr. Cheryl Phillips, who’s President of 

the American Geriatrics Society. She’s also a Geriatrician and 

Chief Medical Officer of On Look Medical Senior Services. As President of the American Geriatrics Society, she represents 6400 geriatric healthcare professionals committed to improving the health 

and well-being of older Americans. 

Finally, we’ll be hearing from Ross Brickley. Mr. Brickley is a 

certified Geriatric Pharmacist and President of CCRX of North 

Carolina, Inc. He’s a past President of the American Society of Consultant Pharmacists and currently serves as a member of ASCP’s 

Board of Trustees and as the Treasurer of that society. 

We’re so pleased that you all took the time to be with us today. 

We’ll commence testimony with you, Mr. Schanke. 

3 

STATEMENT OF MICHAEL SCHANKE, ADMINISTRATOR, 

OAKRIDGE GARDENS NURSING CENTER, MENASHA, WI; ON 

BEHALF OF AMERICAN HEALTH CARE ASSOCIATION AND 

NATIONAL CENTER FOR ASSISTED LIVING 

Mr. SCHANKE. Thank you, Chairman Kohl and members of the 

committee. 

My name is Michael Schanke. My father and I are proud of the 

three long-term care facilities that we own and operate in Wisconsin’s Fox Valley. We have 180 full- and part-time staff, who care 

for more than 140 seniors. 

I appreciate the opportunity to be here today on behalf of so 

many of my fellow long-term care providers to share our collective 

concerns about this issue. 

Most importantly, I’m pleased to be here on behalf of my patients 

and others in facilities nationwide who are facing unacceptable 

delays in getting much needed pain medication. 

I witness firsthand the frustration, fear, and confusion of patients and family members forced to watch their loved ones suffer 

while my staffs struggle with their hands tied because of these 

DEA regulations. Usually, the medication they need to relieve a 

resident’s pain sits within our reach inside of our contingency kit. 

Imagine what it’s like to look into the eyes of a resident or that 

resident’s family as the resident is in clear and sometimes intense 

pain, and having to tell those people that we can’t give medication 

they’ve been taking all along, not because we don’t have it, but because of a regulation. 

Or imagine telling a nursing staff made up of highly educated 

and trained medical professionals who are with patients around the 

clock, assessing their conditions in real time, that they are no 

longer allowed to do the job for which they have been trained. 

We’ve taken numerous steps to comply with the DEA’s increased 

enforcement of the Controlled Substances Act, at times to the detriment of the quality of the life of the patients we serve. 

I would like to share with you one specific example of how the 

DEA rules have interfered with our ability to treat residents in 

pain. In mid-February, on a Thursday, we had an admission of an 

88-year-old lady to our facility from the hospital, following a surgical repair of her L2 vertebrae. As with many of our newly admitted patients, one of our first goals was to manage her intense pain, 

so that she could begin her rehabilitation program, which would include both physical and occupational therapy. 

To treat her pain, the discharging physician ordered two things: 

a Fentanyl patch along with Percocet every 4 hours, as needed, for 

breakthrough pain. By Saturday, my nurses noted that she would 

probably run out of her initial order of Percocet by late Sunday 

afternoon. We immediately put a call out to her attending physician to inform him of the situation and to begin the process for securing more Percocet to treat her pain. Throughout the weekend, 

we followed up, on multiple occasions, with both the doctor and the 

pharmacy to inquire about the status of the Percocet prescription 

and to ensure that the written prescription had been received by 

our pharmacy. Because we were unable to receive this confirmation, by Sunday night we had run out of the initial Percocet preVerDate Nov 24 2008 15:06 Sep 30, 2010 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 H:\DOCS\57545.TXT SAG PsN: JOYCE
4 

scription. In order to provide her with some relief from her intense 

pain, we used contingency medication that we had in our facility. 

By Monday morning, the patient’s pain level had reached a 9 or 

10 on a 10–0 scale. Her family arrived, witnessed that their loved 

one was in such intense pain. They began to question why we were 

not treating her, as they knew we had the orders. We explained to 

her family that, due to changes in our process resulting from the 

need to follow DEA requirements, we would be unable to medicate 

her with her Percocet. 

By this time, the patient’s pain had become so intense and unmanageable that her family decided to have her transported back 

to the hospital emergency room, just before noon on Monday. The 

patient was readmitted to the hospital and treated with morphine 

and an epidural for pain control. She returned to our facilities 3 

days later, after that second hospitalization. 

The example illustrates that the ordering process for Schedule 2 

medications has become too focused on the paperwork, at the expense of patient care and comfort. 

Long-term care facilities work hard daily to meet stringent State 

and Federal regulations, which include adequate pain management 

for our patients. However, these rules pit providers’ compliance 

with those rules against compliance with other regulations. The 

DEA rules also ignore practical realities. 

We are fortunate to be in a medium-size community where we 

have doctors, clinicians, hospital systems, and a family owned 

pharmacy 5 minutes away. Not everyone has this ideal situation. 

The DEA rules imply that physicians are available at beck and 

call, which is not always the case. Healthcare is practiced in a dynamic setting, and the DEA rules are frustratingly static. 

In short, the DEA rules concerning Schedule 2 drugs need to be 

updated to account for the realities of medical practice, nursinghome care, and the three-way system of communication that occurs 

in the real world across care settings. 

Thank you very much for your time and continued attention to 

this important issue. 

[The prepared statement of Mr. Schanke follows:] 

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The CHAIRMAN. Thank you very much, Mr. Schanke. 

Now, we turn to Mr. Warnock. 

STATEMENT OF ROBERT WARNOCK, D.PH., VICE PRESIDENT 

OF PHARMACY SERVICES, GOLDEN LIVING, FORT SMITH, AZ 

Mr. WARNOCK. Chairman Kohl, thank you for inviting me here 

today. 

My name is Robert Warnock. I speak on behalf of Golden Living, 

a leading healthcare services company that operates more than 300 

skilled nursing facilities in 21 States. I am the company’s Vice 

President of pharmacy services. In addition, I am a certified Geriatric Pharmacist and licensed Doctor of Pharmacy. 

I’d like to discuss how some Drug Enforcement Agency regulations are imposing barriers to the timely and medically appropriate 

dispensing of controlled medications in skilled nursing facilities. 

This is essentially a collision of good intentions. 

The DEA works to protect the public against the diversion of 

harmful drugs, but the Agency’s regulations concerning the dispensing of Schedule 2 drugs can cause needless suffering for patients with legitimate medical needs for those medications. 

Additionally, some of these regulations are potentially placing 

skilled nursing facilities at risk of being noncompliant with CMS 

regulations governing the patient-care responsibilities of skilled 

nursing facilities. 

That said, Golden Living fully supports and commends the DEA 

for its role in protecting the public from drug diversion and illegal 

practices regarding the use of controlled substances. We wish to 

work cooperatively with the committee and the DEA, as well as 

Federal and State healthcare regulators, to improve the effectiveness of the regulatory system. However, existing DEA regulations 

are difficult to comply with in our skilled nursing facility environment, particularly in light of CMS regulations under which we already operate. CMS regulations cover the safe and effective handling of medications. 

Conflicting DEA and CMS regulations place skilled nursing facilities in a difficult position. On one hand, DEA regulations increase delays in the provision of needed medication. On the other 

hand, CMS regulations require that skilled nursing facilities provide immediate care of the patient’s needs. Compliance with both 

sets of regulations is challenging and, at times, impossible. 

Current DEA regulations require long-term care pharmacies to 

comply with very specific processes to allow the ordering and dispensing of Schedule 2 controlled drugs, including the requirement 

of hardcopy prescriptions signed by a physician. Skilled nursing facilities do not have onsite 24-hour physician staffs. Each patient 

has an attending physician who is responsible for his or her medical orders. But, most of these physicians maintain their primary 

practice outside of the skilled nursing facility and conduct many of 

their activities offsite and electronically. 

Manual processes for ordering and approving Schedule 2 prescriptions may be acceptable during regular office hours, when physicians, nurses, and long-term care pharmacists are present in 

their regular practice setting. After hours, however, pharmacies 

may be closed, and physicians may not have access to fax maVerDate Nov 24 2008 15:06 Sep 30, 2010 Jkt 000000 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 H:\DOCS\57545.TXT SAG PsN: JOYCE
16 

chines, if they are reachable at all. During these times, the required process frequently results in lengthy delays. 

DEA requirements for skilled nursing facilities differ from those 

under which hospitals operate. DEA provisions help hospitals and 

hospital pharmacies meet the immediate needs of their acute care 

patients for Schedule 2 medications. In hospitals, a physician’s 

order on a patient’s chart serves as a legal order and prescription 

for the pharmacy to fill the controlled substance. Also, nurses in 

hospitals are allowed to serve as physicians’ agents and can order 

the pharmacy to fill a prescription for the controlled substance. 

Similar provisions for skilled nursing facilities would enable us 

to better meet the needs of patients who become acutely ill in our 

facilities or who are in pain at the time of admission. In many 

cases, we would be able to help patients in severe discomfort faster 

than we can under current regulations. 

We would also ask that DEA follow more of an administrative 

approach to their work with skilled nursing facilities. In 2009, 

Golden Living experienced an unannounced inspection of five of our 

skilled nursing facilities by DEA agents. To our knowledge, these 

inspections were unusual and unprecedented. The aggressive law 

enforcement approach used by the DEA agents during these visits, 

including the use of armed escorts, had a chilling impact on facility 

operations. It disrupted the staff and their important caregiving responsibilities, and it frightened our patients and our employees. 

In cases where there is not an immediate concern or issue, we 

would suggest that such disruptions may be mitigated if skilled 

nursing facilities were given advance notice of future DEA visits of 

this nature. 

Thank you for your time today. 

[The prepared statement of Mr. Warnock follows:] 

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The CHAIRMAN. Thank you Mr. Warnock. 

Dr. Phillips. 

STATEMENT OF CHERYL PHILLIPS, M.D., PRESIDENT, 

AMERICAN GERIATRICS SOCIETY, NEW YORK, NY 

Dr. PHILLIPS. Thank you, Chairman Kohl and thank you for taking on this really important issue. 

I will speak as a geriatrician and an advocate, as we all are, for 

the patients and individuals that we’re concerned about throughout 

this. 

In addition to being President of the American Geriatrics Society—and very happy to represent that organization—I’m also the 

past President of the American Medical Director’s Association, 

which is the organization for physicians in long-term care practice. 

My entire clinical practice, scanning some 20 years, has been in the 

long-term care arena. 

This is a very real, palpable issue; it’s not just a theoretical problem. It actually has been, in a variety of States, going on for many 

years, escalating, most recently, with some of the enforcement activities. 

So, I’ll start—we’ve had issues with stories. I, too, will tell the 

story of Mrs. M, who’s demented and 87 and is admitted back to 

the emergency room on a Friday night, after 4 days in the nursing 

home. She goes back to the same hospital she came from, because 

after her hip surgery, her orthopaedic surgeon felt like she needed 

to have less confusing pain meds and reduced her narcotics. 

Every day in the nursing home, her pain was slightly increasing 

until the day of transfer, when the nurse doing an assessment, 

working with the physician, communicating with the family, realized that we were not able to manage, in a timely manner; and the 

family, in frustration, as was mentioned in an earlier example, 

said, ‘‘Enough, already,’’ and sent her back to the hospital. 

I was part of a CMS panel that looked at rehospitalizations. One 

in four Medicare patients who go to the hospital and go to a nursing home are readmitted within 30 days. A big part of this is, in 

fact, pain management. This represents $4.3 billion a year, at 

about $10,000 per admission. Not only is it unnecessary cost, it’s 

unconscionable that Mrs. M needs to go back to the emergency 

room to have what can be provided in a licensed facility with 

nurses, therapists, physicians, and pharmacists ready to take care 

of her. 

So, what can a physician do if we can’t get the narcotic? Well, 

we can use a non-narcotic option; that’s not great. The pharmacy 

and the nurse can go outside of DEA regulations, give the medicine 

anyway, face significant sanctions and fine. Or what often happens 

is, a patient goes without. They’re the ones paying the price and 

suffering. 

It is not insignificant, untreated pain in the elderly. We have a 

lot of myths about pain management in the elderly. When we don’t 

address pain, seniors tend to not eat, they tend to not move, they 

are less mobile, they’re more likely to get pneumonia, they’re more 

likely to fall because of the muscle weakness related to the immobility. They are certainly more likely to have pressure ulcers. It 

often starts that spiral of decline and death. Pain management in 

27 

the elderly is a critical and important medical and social and moral 

issue. 

So, why is it that we have such a problem? As was mentioned 

earlier, in the hospital I can get called by a nurse who gives me 

an informed, professional assessment. I can have an interaction in 

a care plan decision, give an order, and it is executed in the hospital. That same nurse can go across the street to the nursing 

home, use her same assessment skills, can have the same dialog 

with me about a patient that I may have seen in the hospital a day 

earlier, but now I can’t give her that order for narcotic management or other medicines that follow under the schedule purview. 

Instead, I must call a pharmacy. Often it’s a 1–800 number for a 

regional pharmacist, sometimes States away. I will tell, from personal experience, that very often, after hours, that meant I wait for 

the pharmacist to call me back. I then have to find a fax after 

hours; I’m not one that carries one in my car. So, after hours or 

weekends, I need to fax, then, an original signature. Now, I call 

back the nursing home nurse, who then calls the pharmacist to 

verify the order. Each one of these steps takes time. Each one of 

these steps creates the opportunity for significant error. Each one 

of these means that Mrs. M is sitting in pain. That’s if things work 

well. That’s when the stars are aligned. 

More often than not, they aren’t. Most physicians do not have 

faxes at home or in their cars. So, after hours, even though we do 

have 24–7 availability, we don’t have the access to make this electronic communication with the pharmacies. Forty percent of physicians now who practice in nursing home settings don’t have typical 

office practices. So, we are not talking about the same dynamic of 

a physician sitting in a room with a complete support staff. 

So, we do recognize that this is a team relationship. This is not 

delegating work away from the physician to the nurse or the nursing home. This is a collaboration, both of us working in the scope 

of our licenses, with the most important goal of serving the individual. 

We recognize the importance of the DEA’s oversight, but I would 

offer that Mrs. M’s pain is not a law enforcement issue. This really 

is an issue of allowing the nurse to serve as the agent of the physician in this setting of care. We know that diversions occur. They 

occur everywhere. They are no more likely to be in nursing homes 

than elsewhere. There are checks and balances in place that others 

can speak of. 

I commend the effort of this. I wholeheartedly appreciate this 

work. We look forward to working with the DEA. We would like to 

find a regulatory solution to this. If not, I urge that we move toward a legislative solution to allow the nurse to be the managing 

agent. 

Thank you very much. 

[The prepared statement of Dr. Phillips follows:] 

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The CHAIRMAN. Thank you very much, Dr. Phillips. 

Now we speak—we turn to Mr. Brickley. 

STATEMENT OF ROSS BRICKLEY, RPH, PRESIDENT, CONTINUING CARE RX, INC., RALEIGH, NC; ON BEHALF OF AMERICAN SOCIETY OF CONSULTANT PHARMACISTS AND THE 

QUALITY CARE COALITION FOR PATIENTS IN PAIN 

Mr. BRICKLEY. Thank you, Chairman Kohl. 

My name is Ross Brickley. I’m a certified Geriatric Pharmacist 

in practice in North Carolina. 

I’m here on behalf of the American Society of Consultant Pharmacists and The Quality Care Coalition for Patients in Pain, a 

multistakeholder coalition of physicians, nurses, and pharmacists. 

Today, we have filed extensive written comments that describe in 

detail the issues and the background that brings us to this hearing. 

In the short time I have to present my testimony, I want to focus 

on the following: 

First, today across the country, long-term care patients are not 

receiving their controlled medications in a timely basis. Nearly 900 

clinicians responded to a survey that the QCCPP sent out last fall, 

that we are releasing later today. Two-thirds of the respondents 

said that the DEA rules were impeding patients’ access to controlled medications. This number jumped to 86 percent in Ohio, 

where DEA enforcement activity is the highest. 

Second, in addition to delays in treatment, the survey showed 

the difficulty in accessing controlled medications is changing prescribing practices. Just as Dr. Phillips mentioned, physicians are 

now writing for noncontrolled medications that are less effective 

and may create other problems for our frail elderly. 

Third, some nursing facility patients are being sent back to the 

hospital, just as our other panelists have indicated, because they 

could not get prompt medication treatment in the nursing home. 

One example that I had on Monday of this week—and I have all 

the latest technology in my nursing facilities that I serve—but, a 

patient was admitted late in the evening, around 6 p.m. He was 

an end-stage HIV patient on routine narcotic medication; high dose 

every 6 hours. So, he was admitted with chart orders from the hospital. Those were electronically submitted into my health record. I, 

electronically, had everything I needed. Unfortunately, I could not 

legally dispense that medication, because it did not have a quantity 

or a physician signature on that electronic document. 

Subsequently, we worked with the prescribers and such, and 

eventually, over an 18-hour period later, we finally got the signed 

prescription so we could legally dispense them and submit them 

out. I had an automated dispensing device there, one of the most 

highly technologically advanced devices possible. I could not release 

that medication, available in the nursing home, until I had that 

signed prescription in my pharmacy, available to administer. 

Those kind of DEA limitations, with the compliance and the paperwork, just as our other panelists have indicated, create challenges and barriers to patient care. 

Simply stated, the DEA rules were written nearly 40 years ago 

for outpatient treatment where a physician at a local, office would 

see a patient. If a controlled-substance medication was indicated, 

36 

the physician would write that prescription, hand it to the patient. 

The patient would fill it at a local pharmacy. This is a very different setting than what we have in the nursing home environment 

today. 

Chairman Kohl, these issues being discussed today are not new. 

For decades, the DEA and ASCP have met to discuss these issues, 

and the DEA has been fully aware of these systems. As early as 

1974, the DEA’s chief compliance officer, Kenneth Duran, in a letter to ASCP, wrote, ‘‘I’ve long felt that the existing regulations do 

not adequately speak to the nursing home situation, and members 

of my staff are presently reviewing applicable regulations to see if 

we can arrive at a practical solution which does not sacrifice necessary control.’’ 

More than two decades later, in March 1996, DEA’s Thomas 

Gitchel wrote, ‘‘We realize that there’s still some longstanding 

issues of concern, and it’s clear that the drafters of the Controlled 

Substance Act did not envision the evolution of the practice of 

pharmacy and medical care to what it has become today.’’ 

ASCP and I, personally, have continued to meet with the DEA 

for the past 10 years. We have no explanation for—after all these 

years—the DEA has decided to aggressively enforce these outpatient rules. In response to this, long-term care pharmacies have 

been forced to take drastic action. These are huge patient-care 

challenges. 

The rules that the DEA ask us to follow are simply incompatible 

and must be changed. In the interim, we need immediate relief, 

and ask for the following: 

First, the DEA must update its rules and policies for prescribing 

and dispensing controlled medications to reflect the practice realities of nursing home and hospice patients in long-term care facilities. We welcome the opportunity to work with the DEA to help 

them develop these rules. 

Second, to alleviate patient suffering, the DEA has the authority 

now, under the regulation, to clarify that a long-term care facility 

nurse is the agent of the prescriber, and may communicate orders 

to the pharmacy. 

Third, if the DEA does not act, we’ll call upon Congress to enact 

legislation that would require the DEA to recognize the long-term 

care facility nurse as an agent of the prescriber and recognize chart 

orders as legal prescription orders for controlled substances. 

Thank you, Chairman Kohl. 

[The prepared statement of Mr. Brickley follows:] 

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The CHAIRMAN. Thank you very much, Mr. Brickley. 

You’ve all been fairly clear and consistent in your expressions of 

the problem, as you see it. 

Hospital nurses may accept verbal orders from physicians for administration of controlled substances, but nursing home nurses 

may not, according to the DEA. Do you believe the DEA is making 

a reasonable distinction between these care settings? If you don’t 

believe so, explain, maybe again, why not. 

Would you like to try, Mr. Schanke, and then we’ll move on? 

Mr. SCHANKE. In terms of the distinction, I don’t see one. We 

have RNs with the same education and background and, many 

times, the same experience, whether in a hospital or in a nursing 

home. In the nursing home, my RNs are able to accept verbal orders for execution of treatment on any number of items. Why we’re 

segregating, now, this scheduled medication specifically, it doesn’t 

make sense to me, from a purely process standpoint. 

The CHAIRMAN. Yes. Now, some of you may know precisely how 

this thing is working out across the country. This has not always 

been the case. This is, what, a new DEA activity, is that right, Dr. 

Phillips? 

Dr. PHILLIPS. Actually, I would offer—this has been an intermittent activity. Back—I remember having 2-o’clock-in-the-morning 

struggles with dispensing pharmacies, back 2001, 2002, in Northern California. It was typically pharmacies who either had had 

pushback from the DEA or who were particularly focused on this 

interpretation. So, prior to, I would say, in the last year or two, it 

has been spotty enforcement and spotty action, and you might have 

one pharmacy in one county not paying attention to this DEA interpretation, where another county and different pharmacy would, 

which also made it very chaotic for physicians and other practitioners in the long-term care environment. 

So, it’s been a very real issue. It’s not just a brand new issue. 

It has certainly escalated in the past year or two. 

The CHAIRMAN. OK. 

Mr. Warnock, would you make some comments? 

Mr. WARNOCK. Thank you, Senator. 

Agree with what my colleagues have said. The increased enforcement clearly has taken place recently. That is when we started 

having this extra attention paid. That’s when we started having 

issues really come to the forefront in patient care. 

The other piece that I would make the argument is when these 

regulations were written, we never imagined—and I’ve been in 

long-term care for 30 years—we never imagined having the kinds 

of residents and patients that we now accept into a skilled nursing 

facility. These literally are an arm of the hospital. So, these rules 

clearly were designed to take care of custodial-care patients who 

didn’t have immediate, emergent needs, and that’s not the kind of 

residents we have any more. 

The CHAIRMAN. In trying to understand why they are moving so 

clearly in the direction in which they are moving, can any of you 

offer their justification for it? We’ll be hearing from the DEA on the 

next panel, but, you know, you always try and look at it from the 

other person’s point of view and understand what they’re doing and 

why they’re doing it. 

62 

Mr. Brickley, you have some thoughts on that? 

Mr. BRICKLEY. Yes. Putting the shoe on the other foot, Senator, 

you know, the Controlled Substance Act of 1970 is what it is. It 

was written then. It was written for a different patient-care population. As I noted in my reference, even in 1973 and 1974, the DEA 

recognized that there were components of the Controlled Substance 

Act that did not apply, did not fit with our setting. So, I can’t contest of the DEA following the letter of the law. 

The CHAIRMAN. Dr. Phillips? 

Dr. PHILLIPS. Yes, if I may. I believe there’s also some myths and 

misunderstandings of how clinical practice occurs in nursing home 

settings. It is not, as been mentioned, but may be seen by the DEA 

as, an outpatient kind of setting with absent doctors and nurses 

sort of running the show. That, in fact, is not the reality. Physicians are responsible for patients, 24/7. We work in a collaborative 

team-based environment with nurses, therapists, pharmacists, the 

entire spectrum of the license panel. So, decisions are still made in 

orders by physicians who are overseeing the care through the 

agent, in other contexts of care of the nurse in the nursing home. 

So, I think part of the challenge is getting the understanding, 

this is an environment of team-based integrated care for very frail, 

vulnerable individuals with considerable oversights at every step of 

the way, in both prescribing, dispensing, and administering and 

counting for all of the narcotics and other medications present. 

The CHAIRMAN. Now, is it fair to say that all of you would like 

to have the same method of prescribing pain medication in nursing 

home facilities as we have in the hospitals? Is that right? Is that 

what you’re advocating? 

Mr. SCHANKE. Yes. 

The CHAIRMAN. Mr. Schanke? 

Mr. SCHANKE. Absolutely. 

The CHAIRMAN. That’s what you’re advocating. 

Mr. Warnock? 

Mr. WARNOCK. Yes, sir. 

The CHAIRMAN. Dr. Phillips? 

Dr. PHILLIPS. Yes, sir. 

The CHAIRMAN. Mr. Brickley? 

Mr. BRICKLEY. Yes, Chairman. 

The CHAIRMAN. Any of you see any cautionary reasons why that 

shouldn’t be done? Do you have any imagined problems that might 

occur if we were using the same procedure? 

Mr. SCHANKE. Well, I’ll jump in. We’ve been doing it for a while, 

and we’ve got established procedures, in terms of tracking scheduled meds, in particular, from shift to shift, new orders, expired orders. We take managing the scheduled medications extremely seriously, just for many of the reasons the DEA wants us to, and we 

should be. We’re concerned about making sure we don’t have diversion issues and that the meds are used properly for our patients. 

So, extending the nurse as agent of physician to us is not going to 

change any of the sort of foundational things we already do to 

make sure we handle them safely, securely, and they’re administered properly. 

The CHAIRMAN. What are your legal liabilities here? I mean—any 

of you—what happens if, in fact, in your facility, if we were doing 

63 

it as hospitals do it, and somebody badly overprescribes? Are you— 

is there a legal—Dr. Phillips is there a legal liability here? 

Dr. PHILLIPS. Well, there are both licensure and law enforcement 

oversight and oversight of the DEA. So, if I am a negligent practitioner-prescriber, I’m accountable, whether it’s in the community, 

the nursing home, or the hospital. That doesn’t change by the setting; I still am obligated under my license and my oversight in my 

practice. 

So, I think that that piece is not a good argument, that this one 

setting of care—I applaud the DEA’s desire to address diversion 

and all issues of diversion which occur in the hospital, the office, 

the community and nursing home—need to be dealt with. But, it 

is not singularly the nursing home where the risk lies. Yet, we are 

creating the burden of this on the backs and the broken legs of our 

patients. That’s the real tragedy, and I think it’s the unintended 

consequence. 

The CHAIRMAN. Yes. 

Any comments from this panel on anything, whatever? Mr. 

Warnock or Mr. Brickley? 

You’ve been really good and complete in describing the problem, 

and I think we all appreciate that very much. 

Mr. WARNOCK. Thank you, Senator. The only thing I would like 

to express, and I think it’s been expressed very well here today, but 

I don’t want to leave without saying. It is very important that we 

solve this problem. These people deserve better than what we’re 

giving them today, and we need to provide better for them. 

The CHAIRMAN. Well, that’s very good. 

We’re going to have the representative from the DEA here on the 

next panel. If—probably redundant, but if you—if you wanted me 

to ask him a—just in the interest of trying to get to a resolution— 

one question, what would you suggest, Dr. Phillips? 

Dr. PHILLIPS. I guess I would ask, Why the nursing home? What 

is it about this setting that makes it, in particular, a focus for the 

DEA’s interpretation, when licensed nurses are practicing under 

the same scope of practice, the nurses are—the physicians are 

interacting under their same scope of practice, under the same 

State and Federal regulations, why this setting of care is being 

identified and targeted? 

The CHAIRMAN. Why is this any different from a hospital setting? 

Dr. PHILLIPS. Exactly. 

The CHAIRMAN. Is that right? 

Mr. SCHANKE. Yes. 

The CHAIRMAN. Would that be your question? 

Mr. SCHANKE. Yes. 

The CHAIRMAN. I am your faithful servant. 

Dr. PHILLIPS. Very good. 

The CHAIRMAN. Thanks a lot, folks, you’ve been good. 

Dr. PHILLIPS. Thank you. 

Mr. SCHANKE. Thank you. 

The CHAIRMAN. So, we come to our next panel here today. We 

welcome our two witnesses. 

Our first witness on this panel will be Joseph Rannazzisi. Mr. 

Rannazzisi is the Deputy Assistant Administrator in the Office of 

Diversion Control at the Drug Enforcement Administration, located 

64 

in the U.S. Department of Justice. As Deputy Assistant Administrator, he is responsible for overseeing and coordinating major 

pharmaceutical and synthetic drug investigations, drafting and enforcing regulations, as well as establishing drug production quotas. 

We welcome you here today. 

Next, we’ll be hearing from Carmen Catizone. Mr. Catizone is 

the Executive Director of the National Association of Boards of 

Pharmacy, and the Secretary of the Association’s executive committee. The National Association of Boards of Pharmacy is the 

international association that assists members in developing and 

implementing standards for public health. 

We welcome you both here. 

Mr. Rannazzisi, we’ll start with you. 

STATEMENT OF JOSEPH RANNAZZISI, DEPUTY ASSISTANT 

ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG 

ENFORCEMENT ADMINISTRATION, U.S. DEPARTMENT OF 

JUSTICE, WASHINGTON, DC 

Mr. RANNAZZISI. Good afternoon, Chairman Kohl. 

On behalf of Acting Administrator Michele Leonhart and the 

men and women of the Drug Enforcement Administration, thank 

you for holding this hearing on this important issue regarding the 

issue of prescribing controlled substances to patients in long-term 

care facilities. 

DEA is charged with enforcing the Controlled Substances Act 

and its implementing regulations, which were designed, first and 

foremost, to protect the public health and safety. 

DEA accomplishes this mission, in part, through administrative 

and regulatory oversight of more than 1.3 million individuals and 

businesses registered to handle controlled substances. The registrant population consists of manufacturers, importers, wholesalers, distributors, pharmacies, and practitioners. 

With very few exceptions, however, DEA does not regulate longterm care facilities. This is due, in part, to the fact that these facilities typically do not have State controlled-substance registrations 

or hold DEA registrations. 

Controlled substances are powerful and potentially dangerous 

drugs when used improperly and without the proper practitioner 

oversight. That said, the CSA has, in its very core, the unique ability to provide a protective umbrella throughout the controlled-substance distribution chain. By design, the CSA provides built-in 

checks and balances to ensure that controlled substances are dispensed for legitimate need, while protecting the public health and 

safety from diversion. 

The CSA, in implementing regulations, therefore established specific limitations on who is authorized to prescribe, and under what 

conditions. The regulations set forth very precise elements that 

must be included in a prescription to reduce errors and solidify the 

authenticity of the prescription. 

For example, a practitioner—a term clearly defined in the Controlled Substances Act—is the only person who can prescribe a controlled substance. Furthermore, the practitioner must be licensed 

by the State in which he or she practices and must be registered 

by the Drug Enforcement Administration. Once these conditions 

65 

have been met, a practitioner can only prescribe a controlled substance after a determination has been made that the drug is needed for legitimate medical purpose and is prescribed in the usual 

course of professional practice. 

Though the responsibility for proper prescribing and dispensing 

of a controlled substance rests with the practitioner, it’s the pharmacist who’s the final gatekeeper. Under the Controlled Substances 

Act, a corresponding liability rests with the pharmacist to ensure 

that every prescription they fill is valid. They are the last line of 

defense before a controlled substance leaves the closed system of 

distribution. 

DEA understands that the laws and regulations may need to 

adapt whenever possible, to keep pace with advancements in technology, science, or medicine. DEA regularly works with, and solicits 

input from, the medical and scientific community. We also seek 

input from the general public through the notice and comment portion of the regulatory process. Over the years, DEA has promulgated several regulations to address the unique and specific needs 

of patients in long-term care facilities. 

For example, a pharmacist can typically only dispense a Schedule 2 controlled substance upon receipt of an original written prescription signed by a practitioner. However, if a patient is a resident of a long-term care facility, the practitioner can fax the written prescription to the pharmacy. 

As far back as 30 years ago, DEA recognized the need to address 

emergency situations in long-term care facilities by authorizing 

placement of emergency kits in those locations. These kits, however, are the responsibility and property of the DEA-registered 

pharmacy and not the facility. 

In 2005, DEA implemented regulations to allow retail pharmacies to install and operate automatic dispensing machines within long-term care facilities. These systems provide a means for patients to receive their medications in a more expedient manner. 

In 2007, DEA implemented a regulation which permits a practitioner to issue multiple prescriptions for Schedule 2 controlled substances. This option can provide patients with up to a 90-day supply of medicine. In the event of an emergency, DEA has authorized 

pharmacists to dispense Schedule 2 controlled substances upon receipt of a valid oral order from a prescribing practitioner. 

Finally, DEA has drafted an interim final rule that will allow for 

the electronic prescribing of controlled substances, and that rule 

should be posted today at the Office of the Federal Register and 

should be published within the next week or so. 

The current statutory and regulatory regime provides practitioners and pharmacists with a wide variety of mechanisms to deliver medications both safely and timely to patients in long-term 

care facilities. The Drug Enforcement Administration recognizes 

the importance of providing safe and effective medications to patients in need. As technologies evolve, or other circumstances dictate, DEA has and will continue to implement regulations whenever possible, to allow for proper prescribing and dispensing of controlled substances. 

Chairman Kohl, thank you again for your interest on this important matter and ensuring that patients who reside in these faciliVerDate Nov 24 2008 15:06 Sep 30, 2010 Jkt 000000 PO 00000 Frm 00069 Fmt 6633 Sfmt 6633 H:\DOCS\57545.TXT SAG PsN: JOYCE
66 

ties receive appropriate standard of care that they deserve. The Department of Justice and the Drug Enforcement Administration are 

committed to working with Congress on this and other matters. 

Thank you for this opportunity to appear today, and I look forward to answering any questions you may have. 

[The prepared statement of Mr. Rannazzisi follows:] 

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The CHAIRMAN. Thank you very much. 

Mr. Catizone. 

STATEMENT OF CARMEN CATIZONE, DPH, EXECUTIVE DIRECTOR, NATIONAL ASSOCIATION OF BOARDS OF PHARMACY, 

MOUNT PROSPECT, IL 

Mr. CATIZONE. Thank you, Chairman Kohl. 

With me today is—also, is William Winsley, Executive Director 

of the Ohio Board of Pharmacy and President-Elect of NABP. Mr. 

Winsely is uniquely qualified to speak on the issues today, because 

of his extensive background in pharmacy practice and regulation. 

His was the first State to be challenged by these issues. 

NABP appears before you today as an objective third party, with 

our only interest being the patient and the integrity of the medication distribution and dispensing systems. As an association of State 

regulatory agencies, we are not involved in the economics of the 

profession of pharmacy, and therefore, are removed from any direct 

concern with the economic impact on long-term care and long-term 

care practitioners that compliance with Federal and State laws and 

regulations may have, unless patient care suffers as a result of burdensome regulation. 

Mr. Chairman, it’s important to temper today’s hearing with the 

realization that emotions are running high and some of the dire 

consequences predicted to occur will not occur and, in all likelihood, 

if they do occur, will not be to the extent that they have been predicted. Furthermore, the accusations which characterize this struggle have clouded the issue and have obstructed necessary avenues 

of communication. Some of the statements today also falsely accuse 

the DEA and law enforcement authorities of actions that are simply not true. 

We concur that patient care is affected, but we also acknowledge 

that diversion is a serious issue. To what extent each of these unfortunate outcomes is occurring, and the reasons for their occurrence, are at the heart of this hearing. 

As NABP approached this issue, we sought to ignore the inflammatory comments and tried, instead, to determine what the facts 

are and what possible solutions exist. In this regard, we posed two 

questions to those with whom we spoke. 

To the practitioners in the long-term care industry, we asked 

whether compliance with the statutes and regulations of the DEA, 

which are considered intractable, could occur, but has not occurred 

because of the cost and inconvenience to the industry. 

To the DEA and regulatory authorities, we asked whether the 

basis for declaring that industry standards were illegal was statutory and regulatory, or interpretation of statutes and regulations. 

To be perfectly honest, Mr. Chairman, NABP believes that the 

inflexible positions advanced are not entirely accurate or absolute. 

Furthermore, addressing the issues under consideration today in 

an isolated way, even if approached with the wisdom of Solomon, 

might prevent the child from being split, but ultimately would result in further complications and conflicts, because the issues encompass significant areas and interpretations of the Controlled 

Substances Act. 

75 

To this end, the member States of NABP have called for us to 

invite the DEA and all stakeholders, those in long-term care and 

other practice settings, to work with us to review and pose revisions to the Controlled Substances Act. Those revisions would address the issues under consideration today, as well as other issues 

that need to be addressed because of significant changes in practice 

in patient care, technology, and regulation. 

To the immediate question under review by this committee and 

affecting patient care in long-term practices, NABP recommends 

the following course of action: that DEA establish a new registration category for long-term care facilities, as defined by the States, 

with similar privileges and responsibilities as now exist for hospitals. If this could be enacted, the dilemma surrounding chart orders and agent of the prescriber could move toward a resolution. 

Presently the NABP Model Act, and a report developed in collaboration with the American Society for Consultant Pharmacists, 

define long-term care facilities within the definitions of an institutional facility. That definition includes hospitals, and would place 

upon long-term care facilities the same legal and regulatory standing. 

It should be noted, however, that diversion, unacceptable standards of care for our elderly, and outdated regulations would not be 

resolved by this immediate action. For those broader and more encompassing issues, we again recommend a more comprehensive 

analysis and review of the Controlled Substances Act. 

NABP is hopeful that this committee will support our effort and, 

through whatever authority available to it, bring the parties to the 

table to engage in this much-needed and valuable effort on behalf 

of the patient and integrity of the medication distribution and dispensing systems. 

Thank you for the opportunity to comment today. 

Mr. Winsley and I would be glad to answer any questions you 

may have, Mr. Chairman. 

[The prepared statement of Mr. Catizone follows:] 

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The CHAIRMAN. Thank you very much, Mr. Catizone. 

Mr. Rannazzisi, you’ve heard Mr. Catizone testify that DEA 

might well, and should, allow—should create a new registration 

category for nursing homes that will allow them to operate more 

like hospitals do, with respect to ordering controlled substances. Do 

you have a sense that your agency is prepared to work with the 

pharmacy boards, other regulators, as well as the provider community on such a solution? 

Mr. RANNAZZISI. Yes, sir. 

Let me explain our registration process a little. If a State decides 

to register, or give controlled substance authority to, a nursing 

home, depending on the extent of that controlled-substance authority, we would be obligated to register them. So, yes, we would register them. We’d work with them, and we have no problem registering them. However, our registration is based on the State-controlled substance authority that’s granted to the prospective registrant. So, it would be up to the States to make that first step, 

to give them controlled-substance authority, and then we would 

create a new class of registrant to encompass the nursing homes. 

The CHAIRMAN. What kind of an impediment does that present, 

Mr. Catizone? 

Mr. CATIZONE. Mr. Chairman, if the providers support this initiative and work with their State board of pharmacy, we see no impediment on behalf of the boards of pharmacy. The impediment 

would come from the provider community that might oppose this. 

But, if the panelists today were honest and sincere in trying to 

treat the patient, then we would see it moving forward quite quickly. 

The CHAIRMAN. So, you see this as being quite doable. 

Mr. CATIZONE. Yes, sir. 

The CHAIRMAN. Do you, Mr. Rannazzisi? 

Mr. RANNAZZISI. Absolutely. As long as the State controlled-substance authority is in place, yes, sir. It would just take us time to— 

not a lot of time, but time to create that new registrant category, 

but we’d be very expeditious in the creation of that. 

The CHAIRMAN. So, how do you imagine that we—if you have a 

set of—how do you imagine that we might move toward a resolution here that long-term care facilities find satisfactory, as well as 

yourself? What’s the next step? 

Mr. RANNAZZISI. If we’re talking about the registration of the 

long-term care facilities, the next step would be the States to make 

the decision whether they’re going to provide long-term care facilities with controlled—State controlled-substance registration. Once 

that is done, and they’ve been provided with that authority, we’ll 

do the rest. 

The CHAIRMAN. That’s a good answer. 

You heard the providers on the first panel discuss the practical 

dilemmas they face, trying to relieve pain and suffering among 

their residents. What efforts are you making to reach out to longterm care providers in order to help them do what is expected of 

them? 

Mr. RANNAZZISI. As I said in the testimony, the long-term care 

providers are not our registrants. We don’t have any regulatory 

control over them. We don’t inspect them. Our registrants in this 

80 

community would be either the practitioners that are prescribing 

or the pharmacy services corporations that are actually servicing 

the long-term care providers. 

Now, we do a number of different presentations. I think in 2009, 

we did over 25 presentations to all different groups in the medical 

community—the boards, American Medical Association, Mayo Clinic, National Community Pharmacists Association, the National 

Conference—we bring in medical and pharmacy board representatives, the American Society of International Interventional Pain 

Physicians, the list goes on and on—about 25 different presentations, and we talk about all aspects of the Controlled Substances 

Act, and we answer questions related to the Controlled Substances 

Act. 

In this situation, there are two registrants that relate directly to 

the long-term care facilities that are not registrants: the practitioners and the pharmacists, the pharmacists being the gatekeeper 

for the prescriptions, to determine whether they’re valid or not. I 

think that the pharmacists have a very good background, with 40 

years of the Controlled Substances Act, about determining what is 

a valid prescription. Inherent in the Act is a determination that a 

prescription is valid, on both the practitioner’s side and the pharmacist’s side. A prescription, to be valid, is issued for legitimate 

medical purpose in the usual course of professional practice; that’s 

the standard that the doctors are held to. The pharmacists have a 

corresponding responsibility to ensure that that prescription is 

valid, and they’re held to that same standard. The nurse is just a 

facilitator to make sure the medication is received and given to the 

patient. If the pharmacist and the practitioners understand the 

valid prescription requirement, there shouldn’t be a problem with 

the nursing homes. 

The CHAIRMAN. Do you see it that way, Mr. Catizone? 

Mr. CATIZONE. Yes, Chairman Kohl. 

The CHAIRMAN. Well, I get the sense that we may be moving in 

the right direction here. Before we, perhaps, begin to wind up this 

hearing, I would to take the somewhat unusual step of asking the 

Doctor to come back and sit down for a minute. Tell us, Dr. Phillips, if you feel that we’ve made a lot of progress, some progress, 

no progress. What do you think? 

Dr. PHILLIPS. I am delighted to hear—I am—I guess I’m a little 

bit taken back by the sense that somehow we have been inflammatory or exaggerative, because, in fact, these pain events were 

happening last year, they were happening yesterday, they’re happening today, and there will be hundreds of them happening tomorrow, so it is a very real issue. 

I’ll speak from personal experience, and maybe a little bit of ignorance. I had started this issue in California and tried to look at 

a State solution, back 5 years ago, and our State Board of Pharmacy said it was a DEA issue, and they had to go to defer to the 

DEA. Now, I’m hearing from the DEA that, in fact, it’s a States 

issue. So, I guess a little bit of caution on my part is, Are we going 

to do one of these, ‘‘It’s my turn, no, it’s my turn,’’ before it actually 

gets resolved? Where the authority lies, I’m unclear. But, I am concerned that we’ll do a little bit of push-pulling back and forth between the States and the DEA. 

81 

The CHAIRMAN. Go ahead, if you can. 

Mr. RANNAZZISI. Again, inherent in the registration process is a 

requirement that a controlled—the controlled-substance authority 

be granted by the State before DEA can issue a registration. Once 

that State decides how they’re going to grant that controlled-substance authority and the exact authority that they’ll be granted, we 

will proceed with the registration process. It depends on the State. 

The CHAIRMAN. Mr. Catizone. 

Mr. CATIZONE. Chairman Kohl, we will issue that explanation to 

the States, as well as our recommendation that they recognize this. 

Clearly, a letter from this committee or from you, sir, would help 

that process—that we could send to all the States, and work with 

the Congressmen and Senators in their States, as well, saying that 

this is an important initiative, we need to move quickly. That 

would move the issue very quickly. 

The CHAIRMAN. All right, well, I’ll be happy to do it. 

Dr. Phillips, you’ve got a nice smile on your face. 

Dr. PHILLIPS. Well, I think that’s a wonderful next step, and I’m 

delighted and appreciate both the efforts of the DEA, the pharmacy, and also our panel of providers. With your input, this will 

actually start to move. 

Thank you. 

The CHAIRMAN. I think that’s great. I’m moved to speculate and 

think that if we could have had you all working on healthcare, we 

would have done it in a month. It wouldn’t have taken—— 

Dr. PHILLIPS. You should have asked us, huh? [Laughter.] 

The CHAIRMAN. Without all the animosity. 

You’ve all done a great job. We thank you all for being here. I 

think that this has been a very, very good session that we’ve had 

this afternoon. 

Dr. PHILLIPS. Thank you. 

The CHAIRMAN. Thank you so much. 

[Whereupon, at 3 p.m., the hearing was adjourned.] 

(83) 

A P P E N D I X 

MR. SCHANKE’S RESPONSES TO SENATOR BROWNBACK’S QUESTIONS

Question. It is acceptable for nurses in long-term care to take phone and ‘‘chart 

orders’’ for all other medications and treatments—antibiotics, anti-coagulants, insulin, etc. Some of these medications have life threatening implications if the order 

is incorrect and/or administered inappropriately. Given the dispensing controls that 

are in place for narcotics, can’t we accomplish the same physician involvement by 

having them sign the ‘‘chart order’’ with the required information during their next 

visit without requiring the extra step of a retail prescription form? 

Answer. The current procedures for continuation of orders and implementation of 

new orders for existing patients and newly admitted patients are effective for all 

medications and treatments. There is no reason to believe that the same would be 

not be true should we have the ability to include narcotics and other ‘‘schedule’’ 

medications in those procedures. The information required for a narcotic order will 

still be obtained concurrently with the immediate implementation of the physicians 

order for the pain medication. If we had the ability to use the ‘‘chart order’’ or a 

phone order there would be much less potential for a delay in the administration 

of the pain medication. Delays continue to occur while we wait for DEA required 

paperwork/verbal communication to find its way from physician, direct to pharmacist, back to nursing staff before we can give the needed pain medications. 

Question. Do you think it is time to change the CSA act to reflect the practice 

of Long Term Care, similar to what occurs in hospitals? The hospital nurse is employed by the hospital, yet can take orders for narcotics over the phone without the 

need for a written or verbal prescription to the pharmacist. 

Answer. I do think it is time for the CSA act to reflect the practice of Long Term 

Care. Nursing staff in Long Term Care facilities must communicate with the physician and receive that physician’s instructions for any and all treatments and medications, whether new or existing. There is no practical difference in starting/continuing an order for insulin or starting/continuing an order for a pain medication. 

Insulin can be ordered by a physician over the phone to my nursing staff and followed up with a signature. A simple pain medication cannot be ordered over the 

phone, but must have specific paper work completed before we can consider giving 

it. 

The DEA’s enforcement of outdated rules does not prevent diversion. We do not 

have a diversion problem in the Fox Valley according to my local police force and 

our area wide drug enforcement unit. In fact, there has been only one instance of 

diversion of a controlled medication investigated by either agency in the last three 

years and that was an Assisted Living Facility not a Skilled Nursing Facility. As 

was stated at the hearing, diversion is no more likely to occur in a nursing home 

than it is in any other setting. I would submit that our internal controls and procedures make it very difficult to commit diversion and more difficult to continue diversion as evidenced by the virtual absence of policy activity in this area. We take the 

management of controlled medications seriously; our hope is that the DEA will take 

our patient’s pain needs just as seriously. 

MR. WARNOCK’S RESPONSES TO SENATOR BROWNBACK’S QUESTIONS

Question. It is acceptable for nurses in long-term care to take phone and ‘‘chart 

orders’’ for all other medications and treatments—antibiotics, anti-coagulants, insulin, etc. Some of these medications have life threatening implications if the order 

is incorrect and/or administered inappropriately. Given the dispensing controls that 

are in place for narcotics, can’t we accomplish the same physician involvement by 

having them sign the ‘‘chart order’’ with the required information during their next 

visit without requiring the extra step of a retail prescription form? 

84 

Answer. Yes, it is acceptable for all non-controlled drugs to be ordered verbally 

and chart orders are the official orders for these drugs. I agree that we could treat 

controlled drugs just as we do all other drugs and the risk of diversion would not 

change appreciably. 

Question. Do you think it is time to change the CSA act to reflect the practice 

of Long Term Care, similar to what occurs in hospitals? The hospital nurse is employed by the hospital, yet can take orders for narcotics over the phone without the 

need for a written or verbal prescription to the pharmacist. 

Answer. Yes, I believe this is the most reasonable and easily implemented solution to this issue. I only hope we can find a path to accomplish this change quickly 

so we can move forward with better care of our patients more quickly. 

MS. PHILLIPS RESPONSES TO SENATOR BROWNBACK’S QUESTIONS

Question. It is acceptable for nurses in long-term care to take phone and ‘‘chart 

orders’’ for all other medications and treatments—antibiotics, anti-coagulants, insulin, etc. Some of these medications have life threatening implications if the order 

is incorrect and/or administered inappropriately. Given the dispensing controls that 

are in place for narcotics, can’t we accomplish the same physician involvement by 

having them sign the ‘‘chart order’’ with the required information during their next 

visit without requiring the extra step of a retail prescription form? 

Answer. Yes, we can give telephone orders for these other medications and yes, 

they often DO have life-threatening implications if not administered correctly, And 

yes, one piece of what we are saying is that we (physicians) do have to sign the orders within 7 days and thus would also have to sign any orders for narcotics ordered 

as well. There is a check and balance process in place. Every verbal order must be 

signed and the pharmacy will not release meds without an order—so even if the 

nurse were diverting, it would be identified when the physician was asked to sign 

the order. 

Question. Do you think it is time to change the CSA act to reflect the practice 

of Long Term Care, similar to what occurs in hospitals? The hospital nurse is employed by the hospital, yet can take orders for narcotics over the phone without the 

need for a written or verbal prescription to the pharmacist. 

Answer. Yes, very much. What we are hoping is that the nurse will become the 

‘‘agent’’ as it is in the hospital. 

MR. BRICKLEY’S RESPONSES TO SENATOR BROWNBACK’S QUESTION

Question. It is acceptable for nurses in long-term care to take phone and ‘‘chart 

orders’’ for all other medications and treatments—antibiotics, anti-coagulants, insulin, etc. Some of these medications have life threatening implications if the order 

is incorrect and/or administered inappropriately. Given the dispensing controls that 

are in place for narcotics, can’t we accomplish the same physician involvement by 

having them sign the ‘‘chart order’’ with the required information during their next 

visit without requiring the extra step of a retail prescription form? 

Answer. The current monthly physician order sheet recaps do not contain all of 

the data required by the DEA (i.e. quantity, DEA #, patient address, Physician address etc..) Although we could ask 70–80 software companies to re-design the 

monthly physician order re-caps, there is still the patient care barriers for new controlled substance orders for existing or new admissions to the long term care facilities. Only by getting the DEA to recognize a nurse as the agent of the prescriber 

and to recognize a ‘‘chart order’’ as a valid prescription order will be able to promptly dispense controlled substances for these frail, elderly residents. 

Question. Do you think it is time to change the CSA act to reflect the practice 

of Long Term Care, similar to what occurs in hospitals? The hospital nurse is employed by the hospital, yet can take orders for narcotics over the phone without the 

need for a written or verbal prescription to the pharmacist. 

Answer. Yes, it is clearly time to update the Controlled Substance Act to reflect 

the practice standards that are being followed in LTC facilities. The chart orders 

and medical record systems are very similar to a hospital setting so it makes sense 

to modify the CSA to treat LTC facilities similar to hospitals. 

85 

MR. RANNAZZISI’S RESPONSES TO SENATOR BROWNBACK’S QUESTIONS

Question. It is acceptable for nurses in long-term care to take phone and ‘‘chart 

orders’’ for all other medications and treatments-antibiotics, anti-coagulants, insulin, 

etc. Some of these medications have life threatening implications if the order is incorrect and/or administered inappropriately. Given the dispensing controls that are 

in place for narcotics, can’t we accomplish the same physician involvement by having them sign the ‘‘chart order’’ with the required information during their next visit 

without requiring the extra step of a retail prescription form? 

Answer. A proper response to this question requires two important distinctions be 

made: (1) the statutory and regulatory scheme applicable to controlled substances 

includes stringent controls not applicable to— non-controlled substances; and (2) the 

characteristics of a physician’s order for a substance to be dispensed to a patient, 

and the circumstances surrounding that order, determine whether the order is 

deemed a ‘‘chart order’’ or a ‘‘prescription,’’ which in turn determines whether dispensing a controlled substance is authorized under the Controlled Substances Act 

(CSA). 

Even after meeting all applicable requirements under the Federal Food, Drug, 

and Cosmetic Act controlled substance medications can only be dispensed to patients pursuant to the stringent controls imposed by the CSA, because controlled 

substances (as opposed to non-controlled substances) have the potential for abuse, 

and are frequently diverted into the illicit market. 

Next, an appreciation for the differences between a ‘‘chart order’’ and a ‘‘prescription’’ is necessary. A Drug Enforcement Administration (DEA)-registered hospital is 

a ‘‘practitioner’’ within the meaning of the CSA; therefore it is permissible for such 

a hospital to dispense controlled substances directly to patients without a prescription. Because of this, in a hospital setting, a hospital may dispense a controlled substance for immediate administration to a patient pursuant to an order for medication made by a physician who is an agent or employee of the DEA-registered hospital. This may occur, for example, through the issuance of a ‘‘chart order.’’ In this 

context, the term ‘‘chart order’’ should be distinguished from the term ‘‘prescription.’’ 

A prescription, unlike a chart order, must contain all of the information specified 

in 21 C.F.R. § 1306.05, including, among other things, the signature of the physician 

on the day that the order is authorized. 

Unlike hospitals, Long Term Care Facilities (LTCFs) are not DEA registrants. 

Therefore, if a ‘‘chart order’’ at a LTCF contains all of the required elements of a 

prescription, including the signature of a physician on the day that the order is 

signed, then the chart order itself could serve as a valid prescription. The required 

elements, which are set forth in 21 C.F.R. § 1306.05, are as follows: 

• Signature of issuing practitioner 

• Date of issuance (which must be the same day that the prescription is signed) 

•Full name and address of patient 

• Drug name 

• Strength 

• Dosage form 

• Quantity prescribed 

• Directions for use 

• Name, address, and DEA registration number of issuing practitioner 

Depending on the schedule of the drug, there may also be time limitations on how 

long a prescription is valid as well as the number of refills. For example, under 21 

CFR § 1306.22(a), ‘‘No prescription for a controlled substance listed in Schedule III 

or IV shall be filled or refilled more than six months after the date on which such 

prescription was issued and no such prescription authorized to be refilled may be 

refilled more than five times.’’ Additionally, the determination that use of a controlled substance is medically necessary in any particular case must be made by a 

practitioner acting in the usual course of professional practice. See United States v. 

Moore, 423 U.S. 122 (1975); 21 CFR 1306.04(a). Such determinations cannot be delegated to LTCF staff. 

Practically speaking, though, chart orders at non-DEA registered LTCFs typically 

do not contain all of these required elements of a prescription. In particular, chart 

orders at LTCFs often lack the signature of the issuing practitioner, which is critical 

to substantiate that he/she did in fact authorize controlled substance medication(s) 

for a specific legitimate medical need. 

Prescriptions must contain all of the elements listed above primarily because controlled substances, in contrast to non-controlled substances such as antibiotics, anticoagulants, and insulin, have potential for abuse and are frequently diverted into 

the illicit market. Therefore, the dispensing of controlled substances is generally 

86 

subject to tighter controls and more regulatory oversight than non-controlled substances. 

Question. Do you think it is time to change the CSA act to reflect the practice 

of Long Term Care, similar to what occurs in hospitals? The hospital nurse is employed by the hospital, yet can take orders for narcotics over the phone without the 

need for a written or verbal prescription to the pharmacist. 

Answer. The CSA already allows for such a result if the relevant state has granted controlled substance authority to LTCFs in the same way it does for hospitals. 

Hospitals have state controlled substance authority, and are registered with the 

DEA—commensurate with that authority—to handle controlled substances. Individual states make the determination whether to issue licenses to qualified persons 

or facilities to handle controlled substances and under what limitations, and DEA 

registered practitioners may only engage in those activities that are authorized 

under state law for the jurisdiction in which they are located. If an LTCF were to 

satisfy a state’s requirements for licensure as a hospital, such an LTCF could apply 

for DEA registration similar to that of a hospital. If so, registration of the LTCF 

by DEA would permit independent controlled substance authority, allow the facility 

to maintain a common stock of controlled substances on the premises, and the LTCF 

may be able to utilize chart orders like a hospital if allowed under state law and 

commensurate with federal regulations. Registration by DEA would also subject the 

facility to DEA oversight, recordkeeping requirements, and security requirements. 

In order for this option to be fully realized, however, states would first need to enact 

laws or regulations to permit this type of activity by LTCFs. 

Nonetheless, even in the absence of state authorization in this area, the current 

statutory and regulatory regime provides practitioners and pharmacists with a wide 

variety of means to deliver controlled substances both safely and timely to residents 

of LTCFs. Over the years DEA has implemented regulations, consistent with the 

CSA, that were specifically tailored to assist practitioners and pharmacists by making it easier to prescribe and dispense controlled substances to residents of LTCFs. 

Currently, several options exist for a practitioner to prescribe controlled substances 

to their patient in a LTCF setting. The following is a summary of existing regulatory exceptions made to ensure that residents’ medical needs at LTCFs are met: 

•For a controlled substance in schedules II–V a practitioner can manually write 

a prescription for his or her patient. The prescription must be dated as of the date 

signed, and is required to contain specific information including: name and address 

of the patient; drug name and strength; dosage form; quantity prescribed; directions 

for use; and name, address, and DEA number of issuing practitioner. 21 C.F.R. 

§ 1306.05(a). 

•The CSA provides that a controlled substance in schedule II—the most stringent 

schedule for substances having a medicinal purpose and high abuse potential—may 

only be dispensed pursuant to a written prescription of a practitioner. 21 U.S.C. 

§ 829(a). However, should an emergency situation arise, this statutory provision contains an exception that allows practitioners to issue emergency oral prescriptions 

with the regulatory requirement that the oral prescription be immediately reduced 

to writing by the pharmacist and contain all the information required for a written 

prescription, except for the signature of the prescribing individual practitioner, and 

must be followed up within seven days by a written prescription from the practitioner to the dispensing pharmacy. To facilitate the receipt of controlled substances 

under these circumstances, DEA has allowed pharmacies to establish ‘‘emergency 

kits’’ in the LTCF that are routinely stocked with commonly dispensed controlled 

substances. These kits are extensions of the pharmacy and are controlled under the 

pharmacy’s DEA registration. 

• Another means by which residents can receive medications more efficiently is a 

federal regulation that contains a provision specifically designed to accommodate 

LTCFs. The regulation provides for the dispensing of controlled substances on the 

premises of a LTCF through the use of an automated dispensing machine. Such dispensing must still be accomplished via a legitimate prescription, but places the supply of controlled substances on location for convenient dispensing to a patient. 21 

C.F.R. § 1301.27. 

•Though practitioners cannot issue refills for schedule II controlled substance prescriptions, DEA has implemented a regulation that allows practitioners to issue 

multiple prescriptions authorizing a patient to receive up to a 90-day supply for 

these substances. 21 CFR § 1306.12. 

• An exception for delivery of a schedule II prescription to a pharmacy for LTCFs 

also exists at 21 CFR § 1306.11(f). Under this regulation a written prescription containing all the information required by 21 C.F.R. 1306.05, including the signature 

of the practitioner, may be transmitted via fax by the practitioner or practitioner’s 

87 

agent. Partial filling of schedule II prescriptions is also allowed for LTCF residents 

or an individual with a terminal illness as long as the amount dispensed does not 

exceed the total amount prescribed and occurs within 60 days (21 CFR § 1306.l3(b). 

• Schedule III–V prescriptions may also be written but may be refilled up to five 

times in a six-month period as directed by the prescriber. A fax of a written schedule III–V prescription may also be transmitted to a pharmacy by the practitioner 

or the practitioner’s agent. Prescriptions for schedule III–V substances may also be 

orally transmitted by the practitioner to a pharmacy. Partial filling is also permissible for schedule III–V prescriptions not to exceed six months from date of issuance. 

DEA has also published an Interim Final Rule allowing for the electronic prescribing of controlled substances. The effective date of this rule was June 1, 2010. 

This rule provides yet another tool for practitioners to use when prescribing a controlled substance for their patient, including those who reside in an LTCF. This rule 

allows practitioners to use a computer, laptop or PDA device to send a prescription 

to a pharmacy from a remote location instantaneously. 

MR. CATIZONE’S RESPONSES TO SENATOR BROWNBACK’S QUESTIONS

Question. It is acceptable for nurses in long-term care to take phone and ‘‘chart 

orders’’ for all other medications and treatments—antibiotics, anti-coagulants, insulin, etc. Some of these medications have life threatening implications if the order 

is incorrect and/or administered inappropriately. Given the dispensing controls that 

are in place for narcotics, can’t we accomplish the same physician involvement by 

having them sign the ‘‘chart order’’ with the required information during their next 

visit without requiring the extra step of a retail prescription form? 

Answer. The question involves an area of expertise best answered by the DEA. 

Our understanding is that the Controlled Substances (CSA) and accompanying regulations specifically prohibit the activities noted. 

Question. Do you think it is time to change the CSA act to reflect the practice 

of Long Term Care, similar to what occurs in hospitals? The hospital nurse is employed by the hospital, yet can take orders for narcotics over the phone without the 

need for a written or verbal prescription to the pharmacist. 

Answer. NABP believes that the CSA has been effective in protecting patients and 

combating drug diversion since its creation and adoption. However, pharmacy practice in long term care and other settings has changed dramatically since the inception of the CSA more than 30 years ago. The member State Boards of NABP are 

requesting a review of the CSA and amendments to recognize the changes in pharmacy practice across all settings, including long term care. 

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