Program Assistance Letter

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1 Program Assistance Letter DOCUMENT NUMBER: DATE: December 5, 2003 DOCUMENT TITLE: Use of Buprenorphine in Health Center Substance Abuse Treatment Programs TO: All Bureau of Primary Health Care Grantees Primary Care Associations Primary Care Offices Federally-Qualified Health Center Look-Alikes This Program Assistance Letter (PAL) provides information on how health centers providing or planning to provide substance abuse treatment services for opioid dependence, including dependence on prescription opioid medications, can use the authorities in the Drug Addiction Treatment Act of 2000 (DATA 2000) to provide buprenorphine to appropriate patients. It provides general information about the drugs approved by the Food and Drug Administration (FDA) and the procedures adopted by the Substance Abuse and Mental Health Services Administration (SAMHSA) for getting approval for dispensing the drugs in a clinic setting. The need for opioid dependence treatment far exceeds what is currently available. Health centers considering office-based treatment should assess patient need and the capacity of the health center to provide quality treatment. Office-based buprenorphine treatment for opioid dependence is designed to address several needs in accordance with public health objectives: To increase access to treatment; To mainstream the treatment of opioid dependence by coordinating it with treatment of other medical conditions; To offer treatment to patients outside the traditional Opioid Treatment Programs (e.g. methadone clinic system) The information contained in this PAL provides general direction for delivering office-based treatment. The BPHC, in collaboration with SAMHSA s Center for Substance Abuse Treatment (CSAT), is continually refining our guidance and technical assistance to support buprenorphine for the treatment of opioid dependence. SAMHSA has a web site dedicated to this new treatment, available at The web site provides answers to frequently asked questions relating to treatment guidelines, availability of the drug, training, coordination and linkage with other providers of substance abuse services, cost of the medication, and reimbursement for services. The included information is based on publications of the FDA, SAMHSA, the National Institute on Drug Abuse (NIDA), and the drug manufacturer, Reckitt Benckiser Pharmaceuticals, Inc., of Hull, United 1

2 Kingdom, and Richmond, Virginia. It is hoped that this document will help facilitate the use of officebased treatment within health centers. We encourage health centers that currently provide or are interested in providing substance abuse treatment services, including prescription opioid dependence treatment, to take advantage of these therapies to the extent that they can lead to improved health outcomes. If you have any questions regarding information contained in the document, please contact: Suzanne Feetham, Ph. D., on (301) or by to Kathleen McGee on (301) or by to or Harriet G. McCombs, Ph.D., on (301) or by to Sincerely, Attachments Sam Shekar, M.D., M.P.H. Assistant Surgeon General Associate Administrator for Primary Health Care 2

3 OFFICE BASED TREATMENT FOR OPIOID DEPENDENCE THE APPROVED DRUGS: Buprenorphine, a medication that has been clinically researched with the support of the National Institute on Drug Abuse (NIDA) for more than a decade, was approved by the Food and Drug Administration (FDA) on October 8, 2002, for the treatment of opioid dependence, including dependence on prescription opioids and heroin. FDA approved two brand name drugs containing buprenorphine: Subutex and Suboxone. In January 2003, Reckitt Benckiser began shipments of Suboxone to pharmacies in the United States. Suboxone, a combination of buprenorphine and naloxone, is indicated for most patients. It is dispensed sublingually and closely supervised by a physician during the initial induction period until stabilization is achieved and a maintenance dose is determined, if maintenance therapy is desired. A medical withdrawal or detoxification model may also be pursued after stabilization. Buprenorphine, a partial opioid agonist (see details next page), markedly reduces withdrawal symptoms and blocks the effects of subsequently administered opioids. Naloxone, a drug previously approved by the FDA, blocks the effects of opioids if used parenterally, but is not significantly absorbed sublingually and therefore may give Suboxone a low potential for intravenous abuse, since it would precipitate an acute withdrawal in opioid-dependent individuals. The approval of these formulations does not affect the treatment standards of previously approved medication-assisted treatments, such as methadone and LAAM (levo-alpha-acetyl-methadol). According to current Federal regulations, these therapies can only be dispensed in the context of an Opioid Treatment Program. The approval of Subutex and Suboxone does not affect the use of other Schedule II, III, IV, or V medications, such as morphine, that are not approved for the treatment of addiction. Finally, it should be noted that other forms of buprenorphine besides Subutex and Suboxone, e.g., Buprenex, are not approved for treatment of opioid addiction. Two examples for the use of the buprenorphine are provided below. Case 1: Joan is a 45-year-old woman on total remission after multimodal therapy for metastatic breast cancer referred back to you as her primary care provider. She required opioid painkillers for pain management and is painless at present but complains that when you start tapering her medication down, no matter how gradually, she develops dysphoria, vomiting and diarrhea. She will need to be medically withdrawn appropriately. Buprenorphine could be indicated in her case. Case 2: John is a 48-year-old man that you first began seeing several years ago, when he came for treatment of an abscess. He required hospitalization for endocarditis, and has virtually no venous access secondary to his long history of heroin intravenous drug use. He did relatively well in methadone treatment in the past, although he typically ends it because he has difficulty attending the daily clinic. He has multiple family 3

4 responsibilities, including caring for his elderly parents and a mentally retarded brother. He lives in a neighborhood where drugs are readily available, and he has struggled to remain abstinent under these circumstances. You judge him to be moderately motivated, and you are concerned that his continued drug use is placing him at high risk for further medical complications. Buprenorphine could be indicated for him. PHARMACOLOGY AND THERAPEUTIC CONSIDERATIONS Suboxone, a sublingual tablet, comes in two dosage forms: 2 mg buprenorphine/0.5 mg naloxone and 8 mg buprenorphine/2 mg naloxone. Subutex, also a sublingual tablet, is available in 2 mg and 8 mg strengths. Subutex or Suboxone is administered as a single daily dose in the range of 12 to 32 mg/day and their drug labels are available on the FDA Web site at: Less than daily dosing is possible in some patients. Buprenorphine is an opioid partial agonist. This means that, although buprenorphine is an opioid, and thus can produce typical opioid agonist effects and side effects, such as mild euphoria and respiratory depression, its maximal effects are less than those of full agonists like oxycodone, heroin and methadone. At low doses, buprenorphine produces sufficient agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. The agonist effects of buprenorphine increase linearly with increasing doses of the drug until at moderate doses the effects reach a plateau. At that point, the effects do not increase with increases in dose producing the so-called ceiling effect. Thus, buprenorphine carries a lower risk of abuse, dependence, and side effects compared to full opioid agonists. In fact, in high doses and under certain circumstances, buprenorphine, if not used appropriately, can actually block the effects of full opioid agonists and can precipitate withdrawal symptoms in opioid-dependent individuals. Buprenorphine is highly bound to plasma proteins. It is metabolized by the liver via the cytochrome P450 3A4 enzyme system into norbuprenorphine and other metabolites. The half- life of buprenorphine is hours. Safety: Because of its ceiling effect and poor bioavailability, buprenorphine is safer in overdose than opioid full agonists. The maximal effects of buprenorphine appear to occur in the mg dose range for sublingual tablets. Higher doses are unlikely to produce greater effects. Respiratory depression from buprenorphine (or buprenorphine/naloxone) overdose is less likely than from other opioids, although there have been some reports of deaths when injected buprenorphine has been combined with benzodiazepines and other depressants. There is no evidence of organ damage with chronic use of buprenorphine, although increases in liver enzymes are sometimes seen. Likewise, there is no evidence of significant disruption of cognitive or psychomotor performance with buprenorphine maintenance dosing. Information about the use of buprenorphine in pregnant, opioid-dependent women is limited; the few available case reports have not demonstrated any significant problems due to buprenorphine use during pregnancy. Suboxone and Subutex are classified by the FDA as Pregnancy Category C medications. See the Buprenorphine Clinical Practice Guidelines (available soon on SAMHSA s buprenorphine web site) for more information about the use of buprenorphine in pregnancy. Currently, methadone remains 4

5 the standard of care for the medication-assisted treatment of opioid-dependent pregnant women in the United States. Side effects of buprenorphine are similar to those of other opioids and include nausea, vomiting, and constipation. Buprenorphine and buprenorphine/naloxone can precipitate the opioid withdrawal syndrome in opioid dependent patients, if not used appropriately. Signs and symptoms of opioid withdrawal include: Dysphoric mood Nausea or vomiting Muscle aches/cramps Lacrimation Rhinorrhea Pupillary dilation Sweating Piloerection Diarrhea Yawning Mild fever Insomnia Craving Distress/irritability Refer to the Subutex and Suboxone package inserts (http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm) for a complete listing of drug interactions, contraindications, warnings, and precautions. Abuse Potential: Because of its opioid agonist effects, buprenorphine is subject to abuse, particularly by individuals who are not physically dependent on opioids. Naloxone is added to buprenorphine to decrease the likelihood of diversion use and abuse of the combination product by opioid-dependent individuals. Sublingual buprenorphine has moderate bioavailability, while sublingual naloxone has poor bioavailability. Thus, when the buprenorphine/naloxone tablet is taken in sublingual form, the buprenorphine opioid agonist effect predominates, and the naloxone does not precipitate opioid withdrawal in the opioid-dependent user. Naloxone via the parenteral route, however, has good bioavailability. If the sublingual buprenorphine/naloxone tablets are crushed and injected by an opioid-dependent individual, the naloxone effect predominates and can acutely precipitate the opioid withdrawal syndrome. Under certain circumstances buprenorphine by itself can also precipitate withdrawal in opioid-dependent individuals. This is more likely to occur with higher levels of physical dependence, with short time intervals (e.g., less than 2 hours) between a dose of opioid agonist (e.g., methadone) and a dose of buprenorphine, and with higher doses of buprenorphine. 5

6 PHASES OF TREATMENT Ideal candidates for opioid addiction treatment with buprenorphine are individuals who have been objectively diagnosed with opioid addiction, are willing to follow safety precautions for treatment, can be expected to comply with the treatment, have no contraindications to buprenorphine therapy, and who agree to buprenorphine treatment after a review of treatment options. There are three phases of buprenorphine maintenance therapy: induction, stabilization, and maintenance. The induction phase is the medically monitored startup of buprenorphine therapy. Buprenorphine for induction therapy is administered when an opioid-dependent individual has abstained from using fastacting opioids for more than 6 hours and long-acting opioids for more than 24 hours and is in the early stages of opioid withdrawal. If the patient is not in the early stages of withdrawal, i.e., if he or she has other opioids in the bloodstream, then the buprenorphine dose could precipitate acute withdrawal. Induction is typically initiated as observed therapy in the physician s office and it is recommended to be carried out using Suboxone. Subutex should be reserved for selected patients: pregnant women and patients on transition from long-acting opioids. As noted earlier, Buprenex, the parenteral analgesic form of buprenorphine, is not FDA-approved for use in opioid addiction treatment. The stabilization phase begins when the patients have discontinued or greatly reduced the use of their drug of abuse, no longer has cravings, and is experiencing few or no side effects. The buprenorphine dose may need to be adjusted during the stabilization phase. Because of the long half-life of buprenorphine, it is sometimes possible to switch patients to alternate-day dosing once stabilization has been achieved. Counseling can be introduced in this phase. The maintenance phase is reached when the patient is doing well on a steady dose of buprenorphine (preferably buprenorphine/naloxone). The length of time of the maintenance phase is individualized for each patient and may be indefinite. The alternative to going into (or continuing) a maintenance phase, once stabilization has been achieved, is medically supervised withdrawal. This takes the place of what was formerly called detoxification. More detailed information will be available in the Buprenorphine Clinical Practice Guidelines being prepared by SAMHSA. They will be posted on SAMHSA s buprenorphine web site at SUPPORT SERVICES Effective treatment of drug addiction requires comprehensive attention to all of an individual s medical and psychosocial co-morbidities. Pharmacological therapy alone rarely achieves long-term success. Thus, Suboxone and Subutex treatment should be combined with concurrent behavioral therapies and with the provision of needed social services. This point is of such importance that physicians must attest to their capacity to refer patients for counseling when they submit their Notification of Intent to begin prescribing Suboxone and Subutex to SAMHSA. The choice of treatment setting in which to provide non-pharmacological therapies should be determined based on the intensity of intervention required for a patient. The continuum of treatment setting 6

7 intensities ranges from episodic office-based therapy to intensive inpatient therapy. For more information on this topic, refer to the American Society of Addiction Medicine s Patient Placement Criteria (ASAM PPC-2R) (www.asam.org), the most widely used and comprehensive national guidelines for placement, continued stay, and discharge of patients with alcohol and other drug problems. Many different types of behavioral therapies (e.g., Motivational Enhancement Therapy, self-help programs) have been used successfully for substance abuse disorders. The SAMHSA Treatment Improvement Protocol (TIP) series (http://www.samhsa.gov/publications/publications.html) includes a number of documents that contain best practice guidelines for the provision of interventions and therapies for individuals with substance abuse disorders. OBTAINING APPROVAL TO ADMINISTER THE DRUGS The Drug Addiction Treatment Act of 2000 (DATA 2000) now gives physicians the ability both to treat opioid dependence and to monitor patient compliance safely and conveniently in the office, clinic, or hospital. DATA 2000 expands the clinical context of medication-assisted opioid addiction treatment by allowing qualified physicians to dispense or prescribe specially approved schedule III, IV, and V narcotic medications for the treatment of opioid addiction in treatment settings other than the traditional Opioid Treatment Program (i.e., methadone clinic). In addition, DATA 2000 reduces the regulatory burden on physicians who choose to practice opioid addiction therapy by permitting qualified physicians to apply for and receive waivers of the special registration requirements defined in the Controlled Substances Act. Suboxone and Subutex are the first therapies approved for primary care physicians prescribing under DATA The two compounds and the office-based model can expand access to treatment for patients with opioid addiction who now have little or no treatment options. Physicians may administer buprenorphine, as long as the have the minimum eight hours of training mandated by Congress and obtain a waiver that allows them to prescribe certain controlled substances. The physicians are eligible for waivers if they meet the requirements outlined below. This medication is not meant to replace methadone therapy, provided through special methadone treatment facilities, but provides the physician an opportunity to treat patients with opioid dependence, including dependence on prescription pain-killers and heroin. To receive a waiver to practice opioid addiction therapy with approved Schedule III, IV, or V narcotics, a physician must notify the Center for Substance Abuse Treatment (CSAT) in SAMHSA of his or her intent to begin dispensing or prescribing this treatment. This Notification of Intent must be submitted to SAMHSA before the initial dispensing or prescribing of opioid therapy. This can be done either by (1) filling out the waiver notification form attached to this PAL (Attachment A) and faxing it to the Center for Substance Abuse Treatment, Attention: Opioid Treatment Waiver Program at or mailing to the address on the form or (2) filling out and submitting the form on-line at SAMHSA s buprenorphine web site at The Notification of Intent must contain information on the physician's qualifying credentials (as defined below) and additional certifications. And, as stated above, physicians must attest to their capacity to refer opioid addiction therapy patients for appropriate counseling and other non-pharmacologic therapies. The physician must also agree to provide no more than 30 patients with such addiction therapy at any one time. (Note that the 30 patient limit applies to both physicians in solo practice and to entire group practices, and is not affected by the number of a physician's or group s practice locations.) 7

8 As part of the approval process, the Drug Enforcement Administration (DEA) will assign the physician a special identification number. DEA is preparing regulations that will require this ID number to be included on all buprenorphine prescriptions for opioid addiction therapy, along with the physician's regular DEA registration number. To qualify for a waiver under DATA 2000 a licensed physician (MD or DO) must meet any one or more of the following criteria: The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties. The physician holds an addiction certification from the American Society of Addiction Medicine. The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association. The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary of Health and Human Services (Secretary) determines is appropriate for purposes of this subclause. The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug. The physician has such other training or experience as the State medical licensing board (of the State in which the physician will provide maintenance or detoxification treatment) considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients. The physician has such other training or experience as the Secretary considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients (criteria to be established by regulation). TRAINING Information about training opportunities is available on SAMHSA s buprenorphine web site (http://www.buprenorphine.samhsa.gov). Both the American Academy of Addiction Psychiatry (http://www.aaap.org) and the American Psychiatric Association (http://www.psych.org) offer web based training courses. The American Academy of Addiction Psychiatry offers a Buprenorphine CD-ROM training that also meets the criteria for waiver eligibility. In addition, the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Osteopathic Academy of Addiction Medicine and the American Psychiatric Association offer on-site training courses at various locations during the year. 8

9 340B DISCOUNT BPHC Program Assistance Letter Grantees that participate in the 340B Drug Pricing Program may purchase Subutex and Suboxone products at discounted prices not to exceed their 340B ceiling prices. CONCLUSION The availability of an opioid addiction treatment offers an exciting opportunity for health centers to enhance the service they provide. All health center physicians providing substance abuse services, or those that are interested in starting to do so, are encouraged to obtain the necessary training and approval from SAMHSA as expeditiously as possible. 9

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