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11/11/2002

Pharmacists May Dispense New Opioid Addiction Treatment

Kate Traynor

Perhaps little noticed by pharmacists when signed into law, the Drug Addiction Treatment Act of 2000 permits prescribers who meet certain requirements to obtain a waiver allowing them to prescribe or dispense Schedule III, IV, or V controlled substances that have received FDA-approved labeling for the treatment of narcotic addiction.

The agency’s October approval for two such products—Subutex, containing buprepnorphine hydrochloride alone, and Suboxone, containing buprenorphine hydrochloride and naloxone hydrochloride (both manufactured by Reckitt Benckiser)—means that pharmacists may become involved in the outpatient treatment of opioid dependence.

Unlike methadone, a Schedule II controlled substance whose use in the treatment of opiate addition is restricted to specialized clinics, the new products can be dispensed by pharmacists and administered in private physicians’ offices.

Subutex tablets contain 2 or 8 mg of buprenorphine. Suboxone tablets contain a 4:1 ratio of buprenorphine and naloxone—2 mg of buprenorphine and 0.5 mg of naloxone or 8 mg of buprenorphine and 2 mg of naloxone. Buprenorphine is an opiate partial agonist that reduces withdrawal symptoms and blocks the effects of other opioids. Subutex is intended for use during the initial stage of treatment, and Suboxone is intended for use during the maintenance phase of treatment.

In preparation for FDA’s approval of the tablets’ labeling, the Drug Enforcement Administration (DEA) upgraded buprenorphine’s classification to Schedule III. DEA regarded the high-dose sublingual tablets as having a higher potential for abuse than buprenorphine injection, formerly a Schedule V drug.

Physicians who have obtained a waiver allowing them to prescribe the drug products are issued a special DEA identification number in addition to physicians’ original number. To verify that a physician has obtained the waiver, pharmacists can telephone 866-BUP-CSAT or send an e-mail message to info@buprenorphine.samhsa.gov.

FDA is encouraging pharmacists to watch for fraudulent buprenorphine prescriptions, such as prescriptions for one patient from multiple physicians. Another warning sign would be the receipt of many Subutex or Suboxone prescriptions from a single physician, because each physician is permitted to treat no more than 30 patients for opioid addiction at a time.

The agency is also asking pharmacists to be sensitive to the need for privacy when counseling opiate-addicted patients. During counseling sessions, patients who have picked up their Subutex or Suboxone doses should be reminded to return to the physician’s office so that the product, which is to be taken once daily, can be administered under supervision. Patients should also be told that serious overdosage can occur if the sublingual tablets are taken concurrently with benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol.

FDA expects the new products to be available by the end of 2002. About 700 physicians had obtained waivers by early October, FDA said.