Opioid treatment programs can now offer buprenorphine

May 23, 2003 -- The Substance Abuse and Mental Health Services Administration announced an interim final rule that will permit opioid treatment programs serving persons addicted to heroin or narcotic pain relievers to offer buprenorphine treatment along with methadone and ORLAAM.

The rule enables opioid treatment programs that are certified by SAMHSA to use the newly approved buprenorphine products, Subutex and Suboxone, for the maintenance or detoxification treatment of dependence on opioids such as heroin or prescription pain relievers. The rule went into effect May 22, 2003 with a comment period open for 60 days, until July 21, 2003.

"The availability and application of buprenorphine marked a new day in the treatment of addiction," said SAMHSA Administrator Charles G. Curie. "With this interim final rule, physicians in opioid treatment programs will be able to improve, expand and tailor treatment for the individual needs of their patients."

This amendment to the rules for opioid treatment programs will give these 1200 programs two more medications for their approximately 205,000 patients. As with other medical conditions, some patients will do better on one of the buprenorphine medications while others will require methadone or ORLAAM.

Subutex is formulated as a sublingual tablet that contains either 2 or 8 milligrams of buprenorphine. Suboxone is a fixed combination sublingual tablet that contains 2 milligrams of buprenorphine with 0.5 milligrams of naloxone, and 8 milligrams of buprenorphine together with 2 milligrams of naloxone. Naloxone is an opioid antagonist and is present in the Suboxone formulation to reduce its risk of intravenous abuse.

To offer these buprenorphine medications, opioid treatment programs will need to review their state licensing laws and regulations and modify their registration with the Drug Enforcement Administration (DEA) to add Schedule III narcotics to their registration certificates. Opioid treatment programs can initiate this process by fax or letter. The letter should include the OTP's DEA registration number and request that the registration be amended to list Schedule III narcotic drugs. The letter must be signed by the Program Sponsor (Program Director) or Medical Director.

The completed letter can be either faxed to Ms. Ghana Giles at 202-353-1125 or mailed to Ms. Ghana Giles at DEA, Registration Unit - ODRR, Washington, D.C., 20537. Following receipt and review, DEA will issue a modified registration certificate to each OTP. OTPs may contact their local DEA office for additional information on the status of their registration modification. Finally, interested OTPs may contact DEA at 800-882-9539 or online at www.deadiversion.usdoj.gov/drugreg/change_requests/sched_change.htm.

Once registration has been modified, opioid treatment programs can order Subutex and Suboxone directly from the product manufacturer by calling 866-882-2107. Comments on the interim final rule should be submitted to the Division of Pharmacologic Therapy, Center for Substance Abuse Treatment, Rockwall II, Room 6-18, 5600 Fishers Lane, Rockville, MD, 20857; Attention: DPT Federal Register Representative. Comments can be faxed to 301-443-3994 or emailed to DPT_Interimrule@samhsa.gov. The closing date for comments is July 21, 2003.

Information on SAMHSA's programs is available on the Internet at www.samhsa.gov

Posted: May 2003


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