Mechcatie, Elizabeth.
Family Practice News 32(22): 7.
November 15, 2002
The approval of the partial opioid agonist buprenorphine for treating opiate dependence has paved the way for office-based treatment of opioid addiction and far greater access to treatment for hundreds of thousands of heroin addicts across the country.
Two sublingual formulations have been approved: Buprenorphine alone (Subutex), which will be given during the first few days of treatment under supervision, and a combination of buprenorphine and naloxone (Suboxone), which will be used during the maintenance phase of therapy. Naloxone has been added to deter abuse of the drug; if tablets are ground up and used intravenously the naloxone component will precipitate withdrawal symptoms.
Buprenorphine is the first narcotic drug for the treatment of opiate dependence that can be prescribed in an office setting. Buprenorphine is the fourth approved treatment for narcotic addition, following methadone and LAAM (L-alpha-acetylmethadol), schedule II drugs that can be dispensed only in special treatment programs, and naltrexone.
Subutex and Suboxone are schedule III drugs, which under the Drug Abuse Treatment Act of 2000 can now be prescribed in the office setting by physicians who meet certain requirements. Under this law, medications to treat opiate dependence that are less tightly controlled than schedule II drugs can be prescribed in the office setting, with various checks and balances to deter abuse and illegal diversion of the drug.
“It is hoped that with this new law and the availability of these new drugs, treatment will become available to many more patients,” said Dr. Cynthia McCormick, director of the Food and Drug Administration’s division of anesthetic, critical care, and addiction drug products, in Rockville, Md. About 70% of the nearly 1 million opiate addicts in the United States do not have access to treatment because there are not enough treatment programs. The availability of buprenorphine is not expected to replace methadone therapy.
Buprenorphine is considered to have less risk for causing psychological and/or physical dependence than schedule II drugs, she added. Buprenorphine is not a cure for addiction. Rather, the drug is for symptomatic treatment and has been studied and developed “to be used in the context of greater addiction therapy,” which includes psychotherapy counseling, and support, she noted. The risk of respiratory depression associated with high doses or overdoses is less likely than with other opioids, although fatal cases of respiratory depression have been reported in France where it has been available for several years, especially when it has been combined with alcohol or other CNS-depressant drugs.
“The big advantage to buprenorphine is that private doctors who may be treating opiate-addicted patients for HIV, hepatitis, diabetes, or hypertension can also be a qualified provider for buprenorphine–so patients can get both treatments from one physician, and that’s a huge gain,” said Dr. Elinore F. McCance-Katz, chair of the buprenorphine task force of the American Academy of Addiction Psychiatry (AAAP).
To become eligible to provide this treatment, physicians who are not board certified in addiction medicine need to take an 8-hour training session, developed by the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency that deals with substance abuse issues.
Sessions will be provided at meetings by organizations such as the AAAP, the American Society of Addiction Medicine, and the American Psychiatric Association (APA). The AAAP and APA also offers Web-based training courses. (See box.) “We train [physicians] to recognize addiction and how to induct patients onto buprenorphine” and about the necessary medical tests, buprenorphine maintenance treatment, and other kinds of substance abuse services patients are likely to need, including counseling services and urine toxicology screens, said Dr. McCance-Katz, professor of psychiatry and chair of addiction medicine at Virginia Commonwealth University, Richmond.
Physicians also need to apply for a waiver from the Controlled Substances Act, which allows physicians to provide office-based treatment. The waiver form can be obtained from SAMHSA. Physicians who are qualified to provide this treatment will also be assigned a new Drug Enforcement Administration number. Further, they must certify that they will see no more than 30 patients at a time and that they can provide other necessary services for addicts such as counseling on-site or via referrals.
SAMHSA will have a registry of physicians who have been granted a waiver, which pharmacists will be required to check before filling prescriptions via a toll-free number and through the SAMHSA Web site. Buprenorphine, previously approved as a schedule V drug for treating pain in an intravenous formulation, is a partial agonist of the same receptor site that accepts drugs like heroin and morphine. Subutex and Suboxone are available in 2-mg and 8-mg sublingual tablets.
The drugs are marketed by Reckitt Benckiser Pharmaceuticals, which collaborated with the FDA and other government agencies to develop a risk-management program with checks and balances designed to contain the risk for abuse and diversion of buprenorphine and to monitor patients for adverse effects. These measures include narrow distribution channels and monitoring for sudden increases in prescribing patterns that might be a red flag that a physician is exceeding his or her quota, Dr. McCormick said.
Surveillance will also include interviewing substance abusers, monitoring local drug markets, and monitoring adverse-event reports. About 2,000 physicians have received training so far, according to SAMHSA.
For More Information On Buprenorphine
Physicians can obtain information on the approval of buprenorphine and training sessions through the following sources:
- Substance Abuse and Mental Health Services Administration:
www.buprenorphine.samhsa.gov
or SAMHSA’s buprenorphine information center at
866-BUP-CSAT (toll-free, 8:30 a.m. to 5 p.m. EST)
or via e-mail at
[email protected] - The American Society of Addiction Medicine:
www.asam.org
ASAM has scheduled several training sessions for next year in different cities. - The American Academy of Addiction Psychiatry:
www.aaap.org
or 913-262-6161. The AAAP has scheduled training sessions and offers a
Web-based training course on office-based buprenorphine treatment that
meets the 8-hour requirement. More information on the courses can be
found at
www.aaap.org/buprenorphine/buprenorphine.html - The American Psychiatric Association:
www.psych.org
The APA is offering an on-line training course. - The Food and Drug Administration:
www.fda.gov/bbs/topics/ANSWERS/2002/ANS01165.html - Reckitt Benckiser:
www.suboxone.com