Penn LDI Team Leads Senate Health Care Committee Staff Briefing

Addiction and Recovery Specialists Provide Evidence for Methadone Distribution Changes

December 13, 2023

By:

Hoag Levins

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A team of six University of Pennsylvania and University of Pittsburgh addiction and recovery specialists briefed the Senate Committee on potential new methadone policies.

As the U.S. Senate Committee on Health, Education, Labor, and Pensions began considering legislation to recharge the national effort to address the opioid epidemic and overdose death rate, a contingent of academic researchers from the University of Pennsylvania’s Leonard Davis Institute of Health Economics (LDI) and the University of Pittsburgh Medical Center (UPMC) conducted a virtual briefing for a bipartisan group of committee staffers regarding the evidence.

The committee’s work is focused on a proposal for the refunding of the soon-to-expire programs of the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act). The act was a landmark piece of legislation and the largest congressional investment in overdose prevention at that time, supporting a broad range of programs aimed at expanding services and their reach across all aspects of substance use disorder treatment.

The new Senate effort is backgrounded by that fact that 80,000 people (222 per day) continue to die annually of opioid overdoses.

The need for OUD patients to make daily visits to remote methadone dispensing locations limits the usefulness of the drug.

Updating Methadone Regulations

While the committee’s new version of the SUPPORT Act continues and augments many of those previously established programs, it is also considering proposals to include several other pieces of new addiction-related legislation. One of these is the Modernizing Opioid Treatment Access Act (MOTAA) that would alter how methadone is regulated and expand how it is distributed for opioid use disorder (OUD).

Methadone, a synthetic opioid designed not to produce a high while it prevents addiction withdrawal symptoms and cravings, is strictly regulated by current Food and Drug Administration (FDA) regulations. A drug taken once a day, it can only be dispensed by opioid treatment program (OTP) locations certified by the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMSHA’s highly restrictive guidelines significantly limit the number of OUD patients who have access to the drug, which is considered the gold standard for OUD treatments because of the overwhelming evidence of its effectiveness.

Six-Member Penn/UPC Team

In their December 4 virtual meeting with a bipartisan group of Senate committee staffers, the six-member Penn LDI/UPC team of addiction and recovery specialists reviewed the evidence that suggests that making methadone more accessible through pharmacy prescriptions could reduce overdose deaths.

The team members were Ashish Thakrar, MD, MS, LDI Associate Fellow from the Perelman School of Medicine; David Mandell, ScD, LDI Senior Fellow and Director of the Penn Center for Mental Health; Jeffrey Jaeger, MD, FASAM LDI Senior Fellow from Perelman; Julia Hinckley, JD, Director of Policy Strategy at LDI; Paul Joudrey, MD, MPH, of UPMC; and Cambria King of UPMC.

Among the evidence addressed by the team of researchers:

Methadone is the single best treatment for OUD and saving lives. It reduces drug use and related crime at the same time it increases the patient’s ability to get and keep a job.
The current methadone regulations and restrictions have been unchanged since the 1970s and require a patient to come to an OTP treatment center daily to take the oral drug. This requirement to visit a distant physical location every day is what makes it difficult to stay employed and engage in other life-stabilizing activities while in a methadone program.
These OTP restrictions are part of the reason that only 18% of those with OUD are engaged in medication-based opioid use disorder (MOUD) programs, the most effective mode of treatment for addiction.
During the COVID-19 pandemic when emergency measures temporarily lifted in-person, OTP-only dispensing of methadone, methadone use increased for stable patients and there was not an increase in methadone overdoses.