OTPs Can Now Dispense Buprenorphine Take-Homes with No Waiting Periods

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.

Comments

  1. Robert Newman, MD says:

    SAMHSA recently announced a new rule providing flexibility in dispensing buprenorphine for opioid addiction treatment (http://www.ofr.gov/OFRUpload/OFRData/2012-29417_PI.pdf). The flexibility, which does not apply to methadone, is justified by SAMHSA on the basis of “differences in the abuse potential between methadone and buprenorphine, as well as the actual abuse and mortality rates (buprenorphine is lower in each instance).”

    Is there in fact evidence demonstrating that buprenorphine is misused, abused, and diverted to a lesser extent than methadone used in the management of addiction (as opposed to prescriptions for pain management)? Greater safety afforded by the “ceiling effect” attributed to buprenorphine is an important consideration, but would not seem to justify continuing a blanket, rigidly applied, no-exceptions-permitted set of restrictions on take-home of methadone, while allowing clinicians flexibility to determine on an individual basis whether to provide buprenorphine for self-administration, and, if so, for how many days. (It is not clear if OTPs will in future be permitted to prescribe buprenorphine, as office-based physicians may; if so, the ability to get medication from a local pharmacy would represent another enormously important—but difficult to justify—advantage over methadone.)

    It seems clear to me that the attendance demands, rigidly imposed by federal regulation on every patient who receives methadone, reflect the assumption that no methadone recipient, under any circumstances, can be trusted to take home the medication during the first 90 days, and that beyond those initial three months, no methadone recipient can be trusted with more than X days “take-home” after less than Y number of months in treatment. This extremely negative, universally applied, stereotype of patients being treated with methadone strikes me as unwarranted, and, frankly, reprehensible, and the significance of the official view of patients, purely by virtue of their treatment with methadone, will not be lost on staff, patients, and the community.

    Also, logic would seem to dictate that addiction-treatment components mandated (by governmental regulation, “standards” set by organizations such as JCAHO, or self-imposed by programs) should apply—or not apply—equally, regardless of medication utilized. In other words, if it is deemed imperative that a new methadone patient receive weekly individual and/or group counseling, then this should be imposed as well on buprenorphine recipient at the same frequency—or waived for all. If a program feels it’s “best practice” to do weekly (or monthly) random, unannounced urine testing, then presumably buprenorphine recipients should be obliged to have several visits per week (or per month) so that urine collection indeed can be random and unannounced—or (and this is my strong preference) urine-testing demands should be eliminated for all.

    Finally, it is difficult to imagine that patients—new or long-term—if given a choice between required clinic visits as infrequently as once monthly as opposed to daily (!) or five times a week, or . . . , would not overwhelmingly opt for the former regimen. The new rule (42 CFR Part 8, RIN 0930-AA14) states the case succinctly and compellingly in citing “commenters” who “noted that from the patient’s perspective the critical advantage of buprenorphine is the possibility of avoiding the long-term daily attendance for dosing that is required with methadone therapy.” Absolutely correct . . . but how can one perpetuate universal denial of this “critical advantage” to patients with the same medical condition, whose physicians decide that they may be best-served with methadone? And note that those patients, who together with their physicians, conclude that they are not achieving optimal therapeutic outcome with buprenorphine will be very strongly discouraged from switching to methadone, given the inflexible demands, regardless of individual clinical considerations, associated with such a change.

    I am aware of no evidence (evidence!) indicating that buprenorphine is more effective than methadone on subgroups of patients defined by age, duration of dependence, social stability, etc. So just who might one expect to request and be granted the “critical advantage” that will now be associated with buprenorphine treatment? I suspect it will depend on finances: the amount of money that can and will be charged the patient (by clinic or by pharmacist), and the amount that can and will be collected by the program, will be decisive. That does not seem a desirable basis for determining what mediation might be most suitable in individual cases.

    Again, I love the flexibility that will apply to required attendance by patients receiving buprenorphine. At the same time, I deplore the diametrically opposite standards that will govern treatment of patients receiving methadone, and the bias against them that I believe they reflect.

    Robert Newman, MD

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