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Nevada News: Buprenorphine (Suboxone®/Subutex®) Confusion
Reprinted from the April 2007 Nevada State Board of Pharmacy Newsletter.
On June 23, 2005, a final rule was published expanding the Drug Addiction Treatment Act of 2000 to include specifically approved Schedule III, IV, and V medications for use in the treatment of opiate detoxification and maintenance. Currently, Suboxone® (buprenorphine and naloxone) and Subutex® (buprenorphine) are the only two drugs in this category that have been approved by Food and Drug Administration (FDA). A physician must apply for, and receive, a waiver from Drug Enforcement Administration (DEA) to prescribe these medications for detoxification or maintenance purposes. If so certified, the physician is assigned a certification DEA number in which the alpha character is replaced with an “X” in the physician’s original DEA number. Prescriptions for buprenorphine for detoxification or maintenance purposes must include both the existing DEA number and the certification DEA number as it is with methadone.
The question now comes from many of you: “Can any physician prescribe buprenorphine for pain, even though it is “off-label” and the physician has not been certified by DEA to use buprenorphine for opiate addiction?” The answer is “yes”; however, the prescription must indicate on it somewhere (like in the sig) that it is being prescribed for pain, so that the pharmacist knows that it can be dispensed without the “X” DEA number. If you desire further information, please call FDA at 1-888/BUP-CSAT or visit its Web site www.buprenorphine.samhsa.gov. This Web site may also be used (by clicking on “Buprenorphine Locator”) to verify a physician’s status, or you may call 240/276-2716.
