New Jersey Administrative Code › Title 10 - HUMAN SERVICES › Chapter 161B - STANDARDS FOR LICENSURE OF OUTPATIENT SUBSTANCE USE DISORDER TREATMENT FACILITIES › Appendix B

Current through Register Vol. 56, No. 14, July 15, 2024
Administrative Bulletin
Division of Mental Health and Addiction Services
4-2007
Subject: BUPRENORPHINE GUIDELINES
I.
Background
The FDA approved the use of Buprenorphine, in the form of
				Suboxone and Subutex, for the treatment of opioid dependence on October 8, 2002
				for medical maintenance and medically supervised withdrawal. Buprenorphine is a
				partial agonist that is available for use solely by certified physicians in
				addiction medicine and those who have satisfied qualifications set-forth by and
				under the provisions of the Drug Addiction Treatment Act of 2000 (DATA 2000).
				Qualified physicians may prescribe up to 275 patients at one time.
While there are some current federal guidelines for use and the
				practice of opiate treatment, the State of New Jersey's Division of Mental
				Health and Addiction Services (DMHAS) seeks to provide modified details and
				guidelines for the use and practice in New Jersey. These guidelines are meant
				to enhance the existing federal guidelines.
A. Rationale for Buprenorphine Treatment
Patients are reporting for opiate treatment at increasingly
				higher rates than ever before. The opiate drugs are heroin, illegal methadone,
				hydrocodone, and oxycodone. The rates of addiction to prescription medication
				are also increasing at an alarming rate from both licit and illicit use. Recent
				data has shown that two or more narcotic pain medications, oxycodone,
				hydrocodone, and codeine were ranked among the 10 most common drugs involved in
				drug abuse deaths (SAMHSA 2002). The prevalence of heroin addiction has also
				been on the rise and is the highest since the 1970s. The need for effective
				opiate treatment is unquestionable.
It has been long noted that opiate addicted patients who
				present for treatment often find it difficult to remain engaged in treatment,
				detoxification and primary counseling, because the withdrawal is very
				uncomfortable and the craving and compulsion to use is too great to overcome.
				In those situations where patients are able to make a reasonable start in their
				recoveries, they often relapse before they can become fully engaged in
				continuing and aftercare therapy. Use of Buprenorphine can significantly
				address both issues. The detoxification, when indicated, can be performed much
				smoother. The issue of craving can also be managed for longer periods of time
				until the patient can get his or her recovery network and program stabilized.
				Lastly, for those individual patients who require long opiate medication
				therapy, Suboxone or Subutex can be safely utilized. Buprenorphine is approved
				by use for the treatment of opioid use disorder only in the formulation as
				Suboxone or Subutex. Injectable Buprenorphine is not approved for the treatment
				of opioid use disorder.
II.
Services To Be Provided Post
				Detoxification
Buprenorphine therapy is an adjunct to the full treatment
				experience;
not
in lieu of a full treatment experience
which includes stabilization (detoxification or maintenance),
				rehabilitation (counseling and education) and then follow-up (aftercare
				counseling and support groups). All patients accepted into buprenorphine
				therapy must be referred to an OOL licensed substance use disorders treatment
				facility or individual therapists who are certified and/or licensed to provide
				substance abuse counseling. Such licensure and certification shall be current
				and not revoked or suspended.
A. Primary and Aftercare Counseling
The primary counseling providers would need to accept
				buprenorphine therapy as an adjunct to addiction treatment, and not "contrary"
				to the previous concepts of total abstinence. Treatment professionals will need
				initial and ongoing education to effect this significant change in treatment
				philosophy. Those patients who are receiving therapy
should not be in
				segregated groups
. Currently those individuals in treatment with
				co-occurring disorders are not routinely segregated for primary and continuing
				care therapy, and those patients receiving Buprenorphine should not be
				segregated either. Patients on Suboxone or Subutex should be permitted to
				participate in primary and aftercare substance abuse counseling.
B. Patient Assessments/Screening Tools
All patients in all medical encounters should be screened for
				substance use disorders. Those patients who are presenting for substance use
				disorders treatment need to undergo a screening process to determine diagnosis,
				severity of illness, and the selection of an appropriate level of care for
				rehabilitation counseling. Providers should select a screening tool to utilize
				for each and every patient routinely (e.g. CAGE; COWS; CAGE-AID; and Narcotic
				Withdrawal Scale).
C. Complete History and Physical Examination
Each patient should undergo a complete history and physical
				examination. The history should include drug and alcohol use, psychiatric, past
				legal, medical, surgical, and family issues, and previous substance use
				disorders treatment. The physical examination should be complete and be
				specific for signs of addiction. Patient should also undergo a neurological and
				mental status examination. All patients treated with Suboxone or Subutex should
				meet DSM-5 criteria for opioid use disorder.
D. Comprehensive Patient Management and Referrals
All patients should be referred for follow-up of other primary
				medical conditions not being addressed in opiate outpatient therapy by the
				provider. Additionally, all patients with psychiatric diagnoses should be under
				the care of a psychiatrist who is expert in managing patients with addictive
				disorders. Patients need appropriate referral for specialized care of
				non-addiction medical issues.
E. Detoxification
Subutex is the
formulation of choice for detoxification
				in the inpatient setting
. Subutex is Buprenorphine without Naloxone
				and is therefore less likely to induce a withdrawal syndrome in patients that
				are still under the influence of some opiate.
Suboxone
is the formulation of choice for use in outpatient
				detoxification settings.
Suboxone is the Buprenorphine formulated with
				Naloxone which provides added protection and deterrence from using unauthorized
				opiates which is assumed to be a greater risk in the outpatient settings.
				Buprenorphine, when prescribed appropriately, is very effective in stabilizing
				opiate withdrawal symptoms without initiating or worsening withdrawal
				symptomatology in appropriately prepared patients.
Many patients who enter into treatment for opioid use disorder
				are fearful that they will not receive the appropriate care and will be left to
				suffer moderate to severe withdrawal. Therefore, many patients who arrive have
				used an opiate just prior to their arrival. Use of Buprenorphine prematurely
				can induce withdrawal as it is also a partial agonist. It is important to
				instruct the patients that they do not use any opiates at least twelve hours
				before they arrive.
Detoxification is a two-step process; stabilization (the
				amelioration of signs and symptoms of withdrawal) followed by a tapering of the
				medication to zero. Patient selection for rapid detoxification is crucial. Some
				patients may require a slower detoxification occurring over a number of weeks
				and other patients may require maintenance therapy with Buprenorphine.
For those patients who cannot be stabilized and withdrawn from
				Buprenorphine on an inpatient basis, they can be managed by qualified
				providers, Addiction Medicine Physicians or Primary Care Physicians with the
				Buprenorphine Waivers.
Once the patient has begun or completed detoxification, he or
				she is ready for primary substance abuse counseling.
F. Buprenorphine Maintenance
1.Adjunctive Therapy
Once detoxification or stabilization through the adjunctive use
				of Buprenorphine has occurred, primary opiate addiction counseling can commence
				without the distraction of opiate craving and withdrawal. The primary
				counseling should begin at the appropriate level of care as indicated by the
				use of some standardized criteria (ASAM Criteria). Primary counseling can occur
				as residential, intensive outpatient, traditional weekly individual or group
				therapy. While the patient is engaged in primary substance abuse counseling
				treatment, his or her Buprenorphine can be managed by a certified physician
				provider. Upon completion of primary treatment (counseling) and aftercare, the
				patient can continue under the care of a prescribing physician for continued
				use of the Buprenorphine, if indicated.
If patients are stabilized with Subutex they should be switched
				over to Suboxone, which has less of an abuse potential and provides the added
				benefit of being a deterrent to illicit opiate use, during the time of primary
				treatment.
G. After Primary and Aftercare Treatment and Discharge
				Care
After patients have completed their primary and aftercare
				counseling, some patients will have been effectively withdrawn from their
				Buprenorphine therapy while others may be continuing on a maintenance regime.
				These patients will need to follow-up with a provider, their primary care
				physician, another provider with a waiver, or an Addiction Medicine Specialist,
				to prescribe the Buprenorphine. These arrangements should be made prior to
				discharge from the counseling phase of treatment so as not to interrupt the
				maintenance pharmacotherapy.
III.
Treatment Protocols
All physicians are referred to the federal guidelines
				established through the Center for Substance Abuse Treatment (CSAT) for the
				minimum requirements. The New Jersey Guidelines are meant to enhance the
				guidelines put forth by CSAT.
A. 24-Hour Medical Care Availability
During the induction and stabilization phase of Buprenorphine
				therapy, medical care and consultation shall be available on a 24-hour basis.
				This care should be supervised by the waivered physician performing the
				induction.
IV.
Special Populations
A. Buprenorphine and Pregnancy
Currently,
Methadone is still the pharmacotherapy of
				choice
for the treatment of opiate dependent pregnant patients.
				Patients should be offered referral to a Methadone provider for care. If the
				patient, however, refuses or has misgivings about Methadone, Buprenorphine has
				been used successfully. The FDA classifies Buprenorphine as a Category C drug.
				The risks of Category C drugs must be explained to the patient and thereafter
				can be used with informed consent. Buprenorphine use in pregnancy needs to be
				further evaluated by controlled studies. To date, the safety has been
				determined by case series reports. The discussion and informed consent should
				be clearly documented in the patient's chart. Subutex is the formulation of
				choice.
B. Buprenorphine Maintenance and Pain Management
1. Acute Pain
Patients who are on Buprenorphine maintenance and who are
				experiencing
acute pain
should attempt to manage the pain with
non-narcotic medications
in combination with their prescribed
				Buprenorphine. Buprenorphine has analgesic properties and can be an effective
				analgesic. The dose of Buprenorphine can be increased to try to improve the
				analgesia, in conjunction with non-narcotic analgesics. Patients for whom the
				pain is not relieved should undergo aggressive treatment with narcotic
				analgesics. The Buprenorphine should be discontinued while the appropriate
				opiate analgesic is employed to address the acute pain. Once the acute pain has
				been successfully managed, the Buprenorphine should be restarted.
2. Chronic Pain
Opioid dependent patients with
chronic pain are usually
				not good candidates
for Buprenorphine therapy because of the analgesic
				"ceiling effect". These patients fair better with long acting narcotic
				analgesics. Methadone has proven to be an effective choice.
V.
Clinical Guidelines References
For DETOXIFICATION see Clinical Guidelines CSAT TIP #40.
For INDUCTION see Clinical Guidelines CSAT TIP #40.
For MAINTENANCE THERAPY see Clinical Guidelines CSAT TIP
				#40.
For BUPRENORPHINE DISCONTINUATION see Clinical Guidelines CSAT
				TIP #40.
VI.
Scope
Substance use disorders treatment providers or medical
				practitioners using Buprenorphine, in the form of Suboxone and Subutex, for the
				treatment of opioid use disorder for medical maintenance and medically
				supervised withdrawal.