As of January 7, 2013, opioid treatment programs (OTPs) can now dispense buprenorphine take-homes, with no predetermined waiting period for stable patients. The Substance Abuse and Mental Health Services Administration (SAMHSA) at last issued its final rule giving OTPs the welcome flexibility this past November, and the rule was published in the Federal Register December 6, 2012. Fears of diversion were probably the driving force behind the delay in the final rule; the proposed rule was issued in June 2009.
Because Schedule III substances—like buprenorphine—have a lower potential for abuse compared to Schedule II substances—like methadone—there is justification for the less-restrictive rules on dispensing buprenorphine, according to SAMHSA.
Of course, states can have stricter rules. Some require OTPs to be open 7 days a week, and the idea of buprenorphine take-homes isn’t even on their radar screens. Still, the final rule is a very important first step for OTPs and their patients.
Most OTP physicians (80 percent) have already completed the DATA training and obtained the required waivers, according to SAMHSA. OTPs will not have a cap on how many patients they can treat with either buprenorphine or methadone. However, for take-homes, OTPs will still be “required to assess and document each patient’s responsibility and stability to handle opioid drug products, including buprenorphine products,” SAMHSA said in the final rule.
At this important juncture in the history of OTPs, accompanying articles in this issue take a look back at the development of buprenorphine and methadone for treating patients with opioid use disorders, and the differences between the two medications. We also report thoughts from leaders in the field as to what the new rule is likely to mean to OTPs and their patients.
