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Home My WebLink About2016-08-08 16-290 Council Documents (23) Buprenorphine SAMHSA Page 1 of 8 • Home Newsroom Site Map Contact Us X s Subitance Abuse and Modal Haellih arrkrAa a.uon ISearch SAMHSA.gov Search Connect with SAMHSA: Find Help & Topics Programs& Grants Data About Us Publications Treatment Campaigns Programs&Campaigns» Medication-Assisted Treatment» Medicationgo SHARi + and Counseling Treatment»Buprenorphine Medication- Buprenorphine Assisted Treatment Buprenorphine is used in medication-assisted treatment(MAT) to help people reduce or quit their use of heroin or other opiates, such as pain Certification of relievers like morphine. Opioid Treatment Programs Buprenorphine Approved for clinical use in October 2002 by the Food and Drug Waiver Administration (FDA), buprenorphine represents the latest advance in Management medication-assisted treatment(MAT). Medications such as • buprenorphine, in combination with counseling and behavioral therapies, provide a whole-patient approach to the treatment of opioid Oversight of dependency. When taken as prescribed, buprenorphine is safe and Accrediting effective. Bodies Unlike methadone treatment, which must be performed in a highly Medication and structured clinic, buprenorphine is the first medication to treat opioid Counseling dependency that is permitted to be prescribed or dispensed in physician Treatment offices, significantly increasing treatment access. Under the Drug Addiction Treatment Act of 2000 (DATA 2000), qualified U.S. physicians can offer buprenorphine for opioid dependency in various settings, Buprenorphine including in an office, community hospital, health department, or Methadone correctional facility. Learn more about SAMHSA's buprenorphine waiver management. Naltrexone Naloxone SAMHSA-certified opioid treatment programs(OTPs) also are allowed to offer buprenorphine, but only are permitted to dispense treatment. Opioid Learn more about certification of OTPs. Overdose As with all medications used in MAT, buprenorphine is prescribed as Common part of a comprehensive treatment plan that includes counseling and Comorbidities participation in social support programs. Insurance and Buprenorphine offers several benefits to those with opioid dependency Payments and to others for whom treatment in a methadone clinic is not preferred or is less convenient. The FDA has approved the following • Training Materials buprenorphine products: and Resources • Bunavail (buprenorphine and naloxone) buccal film http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine 7/18/2016 Buprenorphine I SAMHSA Page 2 of 8 Physician and • Suboxone (buprenorphine and naloxone) film • Program Data • Zubsolv (buprenorphine and naloxone) sublingual tablets • Buprenorphine-containing transmucosal products for opioid Legislation, dependency Regulations& Guidelines Refer to the product websites for a complete listing of drug About DPT interactions, warnings, and precautions. Buprenorphine How Buprenorphine Works Pharmacy Lookup Buprenorphine has unique pharmacological properties that help: MAT-PDOA • Lower the potential for misuse • Diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings • Increase safety in cases of overdose Buprenorphine is an opioid partial agonist. This means that, like opioids, it produces effects such as euphoria or respiratory depression. With buprenorphine, however, these effects are weaker than those of full drugs such as heroin and methadone. Buprenorphine's opioid effects increase with each dose until at • moderate doses they level off, even with further dose increases. This "ceiling effect"lowers the risk of misuse, dependency, and side effects. Also, because of buprenorphine's long-acting agent, many patients may not have to take it every day. Side Effects of Buprenorphine Buprenorphine's side effects are similar to those of opioids and can include: • Nausea, vomiting, and constipation • Muscle aches and cramps • Cravings • Inability to sleep • Distress and irritability • Fever Buprenorphine Misuse Potential Because of buprenorphine's opioid effects, it can be misused, particularly by people who do not have an opioid dependency. Naloxone is added to buprenorphine to decrease the likelihood of 1111 diversion and misuse of the combination drug product. When these http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine 7/18/2016 Buprenorphine SAMHSA Page 3 of 8 • products are taken as sublingual tablets, buprenorphine's opioid effects dominate and naloxone blocks opioid withdrawals. If the sublingual tablets are crushed and injected, however, the naloxone effect dominates and can bring on opioid withdrawals. Buprenorphine Safety People should use the following precautions when taking buprenorphine: • Do not take other medications without first consulting your doctor. • Do not use illegal drugs, drink alcohol, or take sedatives, tranquilizers, or other drugs that slow breathing. Mixing large amounts of other medications with buprenorphine can lead to overdose or death. • Do ensure that a physician monitors any liver-related health issues that you may have. Pregnant or Breastfeeding Women and Buprenorphine Limited information exists on the use of buprenorphine in women who are pregnant and have an opioid dependency. But the few case reports • available have not demonstrated any significant problems resulting from use of buprenorphine during pregnancy. The FDA classifies buprenorphine products as Pregnancy Category C medications, indicating that the risk of adverse effects has not been ruled out. Review SAMHSA's TIP 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction—2004 and Federal Guidelines for Opioid Treatment Programs—2015 for more information about the use of buprenorphine in pregnancy. In the United States, methadone remains the current standard of care for the use of MAT with pregnant women who have opioid dependency. Treatment with Buprenorphine The ideal candidates for opioid dependency treatment with buprenorphine: • Have been objectively diagnosed with an opioid dependency • Are willing to follow safety precautions for the treatment • Have been cleared of any health conflicts with using buprenorphine • Have reviewed other treatment options before agreeing to buprenorphine treatment • Before buprenorphine treatment begins, policies and procedures should be in place to guarantee patient privacy and the confidentiality of http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine 7/18/2016 Buprenorphine l SAMHSA Page 4 of 8 personally identifiable health information. Under the Confidentiality Regulation, 42 Code of Federal Regulations (CFR) 2, information • relating to substance use and alcohol treatment must be handled with a higher degree of confidentiality than other medical information. Buprenorphine treatment happens in three phases: 1. The Induction Phase is the medically monitored startup of buprenorphine treatment performed in a qualified physician's office or certified OTP using approved buprenorphine products. The medication is administered when a person with an opioid dependency has abstained from using opioids for 12 to 24 hours and is in the early stages of opioid withdrawal. It is important to note that buprenorphine can bring on acute withdrawal for patents who are not in the early stages of withdrawal and who have other opioids in their bloodstream. 2. The Stabilization Phase begins after a patient has discontinued or greatly reduced their misuse of the problem drug, no longer has cravings, and experiences few, if any, side effects. The buprenorphine dose may need to be adjusted during this phase. Because of the long-acting agent of buprenorphine, once patients have been stabilized, they can sometimes switch to alternate-day dosing instead of dosing every day. 3. The Maintenance Phase occurs when a patient is doing well on a steady dose of buprenorphine. The length of time 111 of the maintenance phase is tailored to each patient and could be indefinite. Once an individual is stabilized, an alternative approach would be to go into a medically supervised withdrawal, which makes the transition from a physically dependent state smoother. People then can engage in further rehabilitation—with or without MAT—to prevent a possible relapse. Treatment of opioid dependency with buprenorphine is most effective in combination with counseling services, which can include different forms of behavioral therapy and self-help programs. Learn more about medication and counseling treatment. Switch from Methadone to Buprenorphine Patients can possibly switch from methadone to buprenorphine treatment, but because the two medications are so different, patients may not always be satisfied with the results. Studies indicate that buprenorphine is equally as effective as moderate doses of methadone. However, because buprenorphine is unlikely to be as effective as more optimal-dose methadone, it may not be the treatment of choice for patients with high levels of physical dependency. A number of factors affect whether buprenorphine is a good choice for • someone who is currently receiving methadone. Patients receiving http://www.sarnhsa.gov/medication-assisted-treatment/treatment/buprenorphine 7/18/2016 Buprenorphine I SAMHSA Page 5 of 8 buprenorphine can possibly be switched to methadone. Patients • interested in learning more about switching their treatment should discuss this with their doctor. Learn more about methadone. Training on Providing Buprenorphine Buprenorphine as an opioid use disorder treatment is carefully regulated. Qualified physicians are required to acquire and maintain certifications to legally dispense or prescribe opioid dependency medications. SAMHSA's Division of Pharmacologic Therapies (DPT) makes available required buprenorphine training for physicians, webinars, workshops, and summits, and publications and research. Publications and Resources • Buprenorphine: Guide for Nurses in the Treatment of Opioid Addiction —2009 • Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: Quick Guide for Physicians Based on TIP 40— 2005 • The Facts About Buprenorphine for Treatment of Opioid Addiction —2009; also available in Chinese, Russian, Spanish, and Vietnamese. • Last Updated: 05/31/2016 0 PHYSICIAN LOCATOR it,", f Pl0113 TREATMENT '° . up, 4, ROGR - TORY *,,,, ' . http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine 7/18/2016 Buprenorphine SAMHSA Page 6 of 8 Ali • 1111, PHARMACY LOOKUP New Federal Regulations Increase Limit Rule to 275 Patients Physicians who have prescribed buprenorphine to 100 patients for at least one year can now increase their patient limits to 275 under new federal regulations. Review the final rule in the Federal Register. The form to request the higher limit is not yet available. To receive the form and guidance information, contact the SAMHSA Center for Substance Abuse Treatment(CSAT) at info@buprenorrhine.samhsa.gov. Please include your contact information, your data waiver number and patient limit, and a statement affirming your 100 patient certification for at least one year. For more information, send an email or call 866-BUP-CSAT(866- • 287-2728). Publications » 2014 Buprenorphine Summit: Report of Proceedings (PDF J 3 MB) » Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends— 2009 » Federal Guidelines for Opioid Treatment Programs—2015 » Medication-Assisted Treatment of Alcohol Use Disorder— 2015 » TIP 40: Clinical Guidelines for the Use of Buprenorphine— 2004 i http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine 7/18/2016 Buprenorphine I SAMHSA Page 7 of 8 Related SAMHSA Resources • » Behavioral Health Treatments and Services » Medical Records Privacy and Confidentiality » Mental and Substance Use Disorders » Prescription Drug Misuse and Abuse Contact Us For information on buprenorphine treatment, contact the SAMHSA Center for Substance Abuse Treatment (CSAT) at 866-BUP-CSAT (866-287-2728) or info@buprenorphine.samhsa.gov. For information about other medication-assisted treatment(MAT) or the certification of opioid treatment programs (OTPs), contact the SAMHSA Division of Pharmacologic Therapies at 240-276-2700 or otp-extranet@opioid.samhsa.gov. Contact SAMHSA's regional OTP Compliance Officers to determine if an OTP is qualified to provide treatment for substance use disorders. 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