Proposed Methadone Treatment Legislation May Put Patients at Risk

Philip D. Isherwood, MD
Philip D. Isherwood, MD
8 Min Read

Isherwood is an addiction specialist and medical director of an opioid treatment program.

Overdoses in the U.S. due to opioids are hitting devastating new levels as high-potency synthetic opioids like fentanyl and metonitazene rack the nation. Medication-assisted treatment (MAT) for opioid use disorder is a life-saving intervention with unmatched success in patient outcomes. This typically includes treatment with FDA approved medications, such as methadone or buprenorphine, along with counseling or behavioral health support.

However, I’m concerned that the Modernizing Opioid Treatment Access Act (MOTAA) risks worsening the crisis rather than solving it by dismissing decades of data showing MAT programs are the gold standard for opioid use disorder (OUD) treatment. MOTAA would eliminate the requirement for MAT’s safety guardrails by allowing doctors to prescribe methadone outside of highly structured opioid treatment program (OTP) clinics.

As an addiction specialist working with patients in an office-based opioid treatment center, I see patients every day who are addicted to fentanyl. Like many of my fellow providers, I recognize the urgent need to increase access to treatment as this epidemic evolves. But I believe the approach laid out by MOTAA is unlikely to do so and risks patient and public safety.

High-Potency Synthetic Opioids Demand Complex Treatment

With overwhelming misuse of high-potency synthetic opioids like fentanyl and metonitazene, the OTP approach to methadone treatment is even more essential. Patients taking more dangerous high-potency synthetic opioids often require more time and higher dosing levels than those historically used for heroin treatment. This makes it more challenging to reach a therapeutic dose quickly and safely. On the spectrum of methadone induction, 2 weeks is the least amount of time to reach a maintenance dose (2-8 weeks).

High-potency synthetic opioids usually require more. Even utilizing higher dose methadone induction protocols, many patients need 8-12 weeks to reach a maintenance dose. During the induction time, people don’t feel well and may be more likely to utilize other substances or more substances, which can potentially be fatal.

Methadone is an unusual opioid: it is long-acting with a half-life of 24 to 36 hours, so it accumulates and can cause delayed toxicity, especially with stacked doses that can cause a patient to go to sleep and never wake up. We must accurately gauge patient tolerance, increase doses appropriately, regularly engage with patients, and carefully monitor intake to mitigate the terrible risk of relapse, overdose, and death, especially during the induction and stabilization periods.

These nuances necessitate greater oversight from a care team, with regular patient encounters to address underlying components of addiction, and frequent drug screenings.

Even in buprenorphine treatment, when I am transitioning patients from fentanyl and other high-potency synthetic opioids, I see patients frequently. For methadone, with its more complex pharmacodynamics, I cannot fathom not seeing a patient regularly during induction and stabilization.

Effective MAT Requires Close Oversight and Wraparound Services

In general, daily interactions with patients as we titrate the optimal dose of medication is crucial to safe recovery and long-term retention in MAT. This includes providing wraparound services with frequent patient touch-points: counseling, case management, peer support, and referrals to housing or job assistance, among others. In-depth patient engagement by a multidisciplinary team enables us to tailor a personalized treatment plan to meet individual needs.

Supporters of MOTAA suggest that the benefits of broad deregulation of methadone to allow private practice physicians to prescribe methadone would outweigh the risks. I respectfully and strongly disagree. While methadone is an effective component of OUD treatment, its misuse without supervision and wraparound services can lead to overdose and death.

The dangers of prescribing methadone without supervision have been corroborated in independent reports from the Substance Abuse and Mental Health Services Administration (SAMHSA) and other federal agencies throughout the 2000s, all finding that methadone prescriptions obtained in a physician’s office led to more overdose deaths. Daily interactions with patients as they get titrated up on methadone are crucial to preventing relapse.

The Need for Greater Access to Treatment

Another point made by MOTAA supporters is the need for greater access. They emphasize that if addiction specialist physicians who operate outside of OTPs can prescribe methadone for OUD to be dispensed at community pharmacies, more people can get the help they need.

However, as it is, many doctors remain hesitant to prescribe buprenorphine, even after the federal government eliminated X-waiver requirements, which were frequently cited as a barrier to treatment. Furthermore, patients often report difficulty filling buprenorphine prescriptions at their local pharmacies. Methadone, a schedule II narcotic, is a significantly more potent opioid agonist than buprenorphine; so, even if MOTAA reduced prescribing barriers to methadone, would doctors practicing outside a regulated OTP prescribe it? Would pharmacies carry it, especially at a time when most community pharmacies are stretched thin and understaffed? This bill could lead to additional administrative burdens and liabilities for pharmacists, in addition to scope of practice concerns.

Of course, I agree that we must examine all potential solutions to expand access to methadone treatment, especially for those in rural areas who lack access. One policy idea is to promote innovative partnerships among OTPs and the 1,400 federally qualified health centers already serving 9.6 million rural Americans. Moreover, additional federal investment to increase the number of OTP mobile clinics to serve rural and underserved communities would help. The Biden administration has rightly reduced regulatory barriers to operating these clinics and Medicare now covers their services.

We Need a More Effective Solution

I urge policymakers to take a closer look at MOTAA’s potential pitfalls and encourage SAMHSA and the National Institute on Drug Abuse to study innovative delivery models in pilot programs. Implementing large-scale legislative changes without a strong evidence base may have grave, unintended consequences. Together, we can all work to expand access to evidence-based MAT in ways that don’t endanger patients and our communities.

Philip D. Isherwood, MD, is national medical director of Office-Based Opioid Treatment Services for BayMark Health Services, and co-founder of AppleGate Recovery. He is also the medical director for an OTP in Breaux Bridge, Louisiana, and a member of the American Society of Addiction Medicine and the American Academy of Family Physicians.

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