Buprenorphine (branded as Suboxone) pharmacological treatment for opioid use disorder (addiction) has been shown to reduce risks of adverse events including overdose and to increase treatment retention (Thomas et al. 2014). This post interrogates two Federal laws, the SUPPORT Act of 2018, and the Drug Addiction Treatment Act of 2000 (DATA 2000), which place patient caps on physicians who prescribe buprenorphine for opioid use disorder (OUD). The SUPPORT Act provides an improvement on DATA 2000 restrictions, but further work remains to improve regulations on prescribing. Under the SUPPORT Act, physicians must train for 8 hours to prescribe buprenorphine for addiction, they are initially limited to 30 patients and must complete another application to prescribe beyond 30 patients, unless they are board-certified in addiction medicine or addiction psychiatry or qualifying practitioners practicing in a qualified practice setting, in which case clinicians can immediately treat up to 100 patients with buprenorphine (SUPPORT Act). Physicians who have prescribed buprenorphine treatment to 100 patients for at least one year can apply to increase the limit to 275 patients. There is no process of appeal to expand patient caps beyond 275 patients, or obtain a waiver on the 8 hours of training, and in many rural counties in the US there are no providers available who are certified to prescribe buprenorphine. I contend that these regulatory restrictions on prescribers are contrary to the aims of treating OUD, and mainly serve to make manageable a system of discipline placed upon providers which limits providers' clinical discretion to the detriment of patients.
This post assumes that policies should conform with a harm reduction framework according to which policies should aim to reduce the negative consequences of drug use without prioritizing abstinence (Marlatt 1996). Harm reduction aims to save lives and improve outcomes by meeting people where they are. I contend that buprenorphine regulations should, at least, allow providers to appeal to expand patient caps beyond 275 patients, and to obtain a waiver on the 8 hours of training in cases of hardship or clinical urgency.
What do you think? Should the law abolish (or reduce) the 8 hour training requirement for buprenorphine prescribers, given that there is no equivalent requirement for oxycodone prescribing despite that oxycodone is far more lethal than buprenorphine, and is similarly subject to diversion?
As a Board-certified Psychiatric Pharmacist, I support the mandatory training. There is now a flexible option for those in remote areas.
Half and Half (Webinar)
Physicians sign up for and attend a 4 hour virtual webinar via computer taught by a clinical expert. Once completed, participants will receive the second half of the course – a 4 hour online self-study portion. At the end of the course, participants are required to pass an exam with a 75% or higher before applying for their waiver.
What I don’t support is the exclusion of Qualified pharmacists from
also prescribing while at the same time expanding the roles of NPs and PAs. Pharmacists are called “the drug experts” but we certainly aren’t treated that way.
Is there a particular reason to require physicians to undergo additional training to prescribe buprenorphine for treatment of addiction, but NOT require additional training to prescribe opioid pain killers such as oxycodone, given then both are subject to misuse and diversion and that oxycodone presents a greater risk of overdose?
There is a good discussion about restrictions on the accessibility of buprenorphine treatment, from the Royal Australian College of General Practitioners, here;
https://www1.racgp.org.au/newsgp/clinical/should-all-gps-be-able-to-prescribe-buprenorphine
Christopher, we are now seeing the results of the lack of training that you mentioned regarding opioids. Now all health disciplines- including mine (Pharmacy)- are playing catch up. A bit late. A friend just lost her second child to the opiate crisis this weekend.
Recent JAMA Forum article on increasing access to opioid pharmacotherapy in the US;
"Avoiding future cases of opioid addiction, however, does little to address the harm that already exists. More than 2 million US residents now have an opioid use disorder. Yet the Surgeon General’s Report Facing Addiction in America found major gaps in access to effective treatment. The gaps go beyond financial and geographic barriers to include major quality concerns. In 2016, among those with opioid addiction who were able to receive specialty addiction care, only about 1 in 3 expected to receive treatment with medications. Yet it is the use of medications, particularly methadone and buprenorphine, that has the greatest potential to save lives. These treatments are associated with substantial reductions in the risk of death for individual patients and many fewer overdose fatalities at the population level.
Physician Training Needed
To save more lives from opioid addiction, physicians need training. That’s why we support a simple proposal: that the Accreditation Council on Graduate Medical Education (ACGME) require all residents in clinical specialties to take a course on the appropriate use of buprenorphine and other medications approved by the US Food and Drug Administration for the treatment of opioid addiction. This course is available for free. A second idea (put forward by Massachusetts addiction specialist Sarah Wakeman, MD) is for ACGME to require that all core faculty in these residency training programs apply for and receive the waiver needed to prescribe buprenorphine from the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration (DEA)."
Article Making Amends for the Opioid Epidemic
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