SAMHSA issues final rule allowing OTPs to dispense take-home buprenorphine
December 17, 2012

Opioid treatment programs (OTPs) will soon be able to dispense a month’s supply of buprenorphine to patients under a long-awaited final rule issued by the Substance Abuse and Mental Health Services Administration (SAMHSA). Currently, patients must wait one year before they can have a two-week take-home supply of methadone. Under the new rule, the same restrictions apply to methadone, but newly admitted and current patients can initiate or switch to take-home buprenorphine as soon as the rule takes effect, which will be 30 days after it is published in the Federal Register, expected within the next few days.

“These types of requirements impart a burden on patients and may affect their adherence to treatment,” SAMHSA said in supplementary information to the final rule, referring to take-home limitations. Daily dosing is required with both methadone and buprenorphine; no take-homes mean the patients must come to the clinic every day, which is beneficial for patients who need additional support but an inconvenience and sometimes a deterrent to treatment for those who do not.

Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), was clearly thrilled that, at last, the final rule has been issued. “We’ve been writing in support of this for more than seven years,” he told ADAW.

Philip L. Herschman, Ph.D., chief clinical officer of CRC Health Group, which has many OTPs throughout the country, said the change is welcome. “We’ve already been building the buprenorphine product business, both with Suboxone and generic buprenorphine,” he said (generic buprenorphine is buprenorphine without the naloxone). “This just adds to that growth.” At CRC, some patients are already starting to switch to generic buprenorphine from methadone, said Herschman.

Counseling and other services

Citing buprenorphine’s safety profile, as well as the experience of OTPs in treating challenging patients, SAMHSA is giving OTPs flexibility in take-homes of buprenorphine only. “The added flexibility will also benefit patients, who should be able to report to the OTP less frequently, while still benefitting from the counseling, medical, recovery and other services OTPs provide.”

Nicholas Reuter, senior public health analyst with SAMHSA’s Center for Substance Abuse Treatment and the author of the final rule, told ADAW that the lack of drug testing, counseling and other services provided by office-based physicians may be one reason for the increased abuse and diversion of buprenorphine. “OTPs take a very, very careful approach,” he said.

Under the final rule, OTPs are still required to assess patients before dispensing take-homes, and still required to provide counseling. Office- based physicians who prescribe buprenorphine do not have to do either, the rule noted, suggesting that this was the reason OTPs do not have the 100-patient cap that officebased physicians have.

While there may be an increased risk of diversion and abuse, the Department of Health and Human Services (HHS) said the “benefits of increased flexibility and increased access to care in OTP settings outweighs these possible risks.”

In fact, fears of diversion are likely what held up the final rule. Ironically, the delay made it possible to show that diversion — which is increasing and very worrying to officials — existed before OTPs even were approved to dispense buprenorphine. This proved that the office-based system, called office-based opioid treatment (OBOT), led to diversion in the absence of counseling and supportive treatment. Claims that OTP patients would divert buprenorphine take-homes were spurious, said Parrino.

Methadone vs. buprenorphine

Walter Ginter, project director of the Medication Assisted Recovery Support (MARS) project at the National Alliance for Medication Assisted Recovery, told ADAW he is concerned that patients will want to switch to buprenorphine to get the take-homes. “We have already seen this in places where methadone is available through a clinic, and buprenorphine is available through a doctor’s private practice,” he said. “Some patients switch to buprenorphine and relapse.”

Ginter comes from the perspective of having been maintained on both medications. He is currently on a high dose of methadone, and has been for many years. But in the 1990s he participated as a patient in the studies of buprenorphine. He liked it but preferred methadone, reflecting the fact that different medications work better for different patients.

OTPs won’t dispense takehomes of buprenorphine — or methadone — unless a patient is ready, said Herschman. Regardless of what a patient “wants,” if the patient isn’t ready for take-homes, he or she won’t get them, he said.