President George W. Bush recently signed into law H.R. 6344, The Office of National Drug Control Policy Reauthorization Act of 2006. The law raises from 30 to 100 the number of patients a physician may treat for opioid addiction with buprenorphine (Subutex, Reckitt Benckiser Pharmaceuticals) C-III sublingual tablets or buprenorphine/naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) C-III sublingual tablets. Buprenorphine is the only controlled medication to receive Food & Drug Administration approval for this indication.
The 30-patient prescribing limit on individual physicians was part of the original Drug Addiction Treatment Act of 2000 (DATA 2000) that allowed office-based treatment with Schedule III-V drugs indicated for opioid dependence. To qualify for the 100-patient prescribing limit now allowed by law, doctors must be certified to treat opioid addiction with buprenorphine for at least a year, explained Edwin Salsitz, M.D., medical director of office-based opioid agonist therapy at Beth Israel Medical Center in New York City.
The locator does not list every physician with a valid waiver, however-just those who have agreed to be listed. Pharmacists wishing to verify that a physician not listed on the site has a valid DATA 2000 waiver number can contact SAMHSA at (240) 276-2716 or by e-mail at email@example.com
Salsitz said that a waiver number is not required when buprenorphine is prescribed for off-label use. He did mention, though, that it would be nice if physicians wrote something on the prescription form about the indication-for example, "Take one tablet twice daily for chronic pain." He went on to say that it is very reasonable for a pharmacist to call the prescriber and verify whether the drug is being prescribed for on-or off-label use.
Pharmacists are in an excellent position to educate the general public about buprenorphine therapy for opioid addiction. Timothy Lepak, president of the National Alliance of Advocates for Buprenorphine Treatment (http:// http://www.naabt.org/), reported that the organization recently launched a pharmacy outreach initiative that is currently piloting in New York City, Detroit, and Philadelphia. Pharmacists in those cities received a postcard directing them to the Web site at http:// http://www.naabt.org/pharm/, where they can order free educational materials and counter displays for their pharmacy and opt to be listed in the pharmacy locator as a buprenorphine-stocking pharmacy.
"Although most pharmacies can get buprenorphine rather quickly, very often timing is critical, because patients must be in the early stages of withdrawal when they take it," said Lepak. "If they have to wait, patients could be in severe withdrawal, and the risk of relapse increases tremendously." He said that the pharmacy locator would work like the NAABT physician locator (http:// http://www.naabt.org/patient_dr_connection.cfm), which uses patient ZIP codes to identify nearby physicians certified to treat opioid addiction with buprenorphine.