On March 3-4, the National Academy of Sciences, Engineering, and Medicine (NASEM) hosted a workshop on how to expand access to methadone. We covered the entire meeting and will include individual stories focused on specific topics. The main point of the NASEM workshop was how to expand access to methadone for opioid use disorder (OUD) in non-legislative ways.
AT Forum has already written about the two main bills in Congress which would remove many of the federal regulations governing opioid treatment programs (OTPs), the only providers allowed to dispense methadone for the treatment of OUD. The American Association for the Treatment of Opioid Dependence (AATOD) which has OTPs as its membership base endorses most of these changes, but notably, not the changes which exclude OTP clinicians from decision-making in what patients receive take-homes, how much, and in what way (see https://atforum.com/2022/03/aatod-methadone-reform-bills-dispensing/).
Alan I. Leshner, Ph.D.., former head of the National Institute on Drug Abuse (NIDA) and Chief Executive Officer emeritus of the American Association for the Advancement of Science, headed the workshop.
In this article, we focus on the discussions around expanding methadone for OUD to primary care. This is really a two-part process, involving prescribing by primary care and dispensing by pharmacies, neither of which is allowed currently. Buprenorphine can be prescribed by primary care providers and dispensed by pharmacies.
“We need to think about prescribing in primary care,” said Magdalena Cerdá, DrPH, Associate Professor and Director of the Center for Opioid Epidemiology and Policy at the Department of Population Health at NYU Grossman School of Medicine. The rationale for this is partly the skyrocketing of opioid overdose rates, and the segregation by race of treatment (OTPs are more likely to be located in Black communities, and buprenorphine providers are more likely to be located in white communities, she said). In addition, there are workforce issues regarding OTPs, because “the requirement that facilities offer counseling makes it difficult to staff up.” She also urged that the possibility of community settings to dispense methadone be explored and expanded.
One anonymous question from the comment section was:
“Before the 2010-2012 restrictions on opioid prescribing for pain, rx opioid overdose deaths exceeded those due to heroin. At that time, methadone was among the top 3 rx opioids involved in fatal overdoses. If we move methadone to primary care to enhance access how do we avoid old overdose trends?”
A response, also from the comment section, came from Gail Groves Scott, M.P.H. who said: “Doctors prescribing methadone for pain during the spike in the overdoses did not have training” in the pharmacology of the medication, and that most of the physicians prescribing it were primary care or internal medicine physicians, not pain specialists. She further noted that the methadone prescriptions for pain were mostly driving by insurance coverage and formularies. Good methadone maintenance treatment for OUD requires “trained clinicians and informed patients,” she noted.
There are also questions about how the actual changes would be implemented, which is why Bridget Dooling, J.D., is a research professor with the George Washington University Regulatory Studies Center, and formerly with the federal Office of Management and Budget, said it’s better to direct efforts to Congress instead of to federal agencies. Nothing in the Controlled Substances Act says that methadone has to be delivered exclusively by OTPs, she noted. While there are “amazing tales of innovation and heroics,” it should be “easier to pilot new ways of treatment,” she said. “There are a lot of cooks in this regulatory kitchen.”
Let’s say that President Biden does decide that methadone should be more easily available, she speculated. “Whose job is it to implement that decision? I didn’t hear whose job it is to do this. SAMHSA? DEA? ONDCP? ASPA? FDA? And this is just at the federal level.” One idea put forward is that an Executive Order task the ONDCP – or someone else – implement the concept of removing barriers to medications, as President Biden suggested in his March 8 State of the Union message.
Dooling suggested that SAMHSA, which already has broad authority under the Controlled Substances Act to shape the way methadone is prescribed, move toward more take-homes and “take a look at its regulations to see what’s outdated,” said Dooling. “We know so much more about addiction and opioids than we used to.”
Corey Davis, a lawyer who is director of the Harm Reduction Legal Project of the Network for Public Health Law, said the very fact that OTPs are the only place to get methadone “is a barrier to care.” Even if all of the regulations were eliminated, there are still “huge swaths of the country where the OTP is more than two hours away,” said Davis. “We know that methadone works, improves outcomes, saves lives, but it is unnecessarily regulated,” he said.
Like many, Davis noted that the liberalized take-homes during the epidemic have not resulted in increased diversion or overdoses. However, also like many, he did not mention the fact that in each and every case, these take-homes were supervised by the OTP, which selected which patients were stable enough to receive take-homes, and how many take-homes.
“The big thing that needs to be changes is that methadone for OUD only come from OTPs,” concluded Davis.
Stay tuned for more reports from the NASEM workshop.