Allowing pharmacies to dispense methadone is dangerous for patients and communities

Congress is expected to pass a massive $1.7 trillion omnibus spending package that includes numerous provisions aimed at addressing the opioid epidemic. I have been advocating for greater access to opioid addiction treatment for more than two decades. While the spending package contains many positive opioid treatment reforms, I am deeply concerned that Congress and others without on-the-ground experience will continue pushing dangerous policies to solve the opioid epidemic in the next Congress.

Many Americans with opioid use disorder go to one of the nearly 2,000 opioid treatment programs (OTPs) in the U.S. to receive high-quality, evidence-based care. These highly regulated facilities are made up of multidisciplinary teams of physicians, nurses, counselors, and social workers who provide comprehensive medication-assisted treatment.

As someone who has worked for nearly 30 years in operational, management, and executive roles at opioid treatment programs, I have seen firsthand how this epidemic afflicts Americans from all walks of life. Opioid use disorder, like diabetes and other chronic conditions, requires highly personalized care plans that evolve with an individual’s health and life circumstances. This combination of medicine with wraparound support services like counseling addresses the psychosocial issues that lead to and perpetuate the cycle of addiction and relapse.

Methadone is one of three FDA-approved medications that can be used to treat people with opioid use disorder. (The others are buprenorphine and naltrexone.) It is also a dangerous narcotic when misused and can cause fatal overdose. In 2004, the federal Substance Abuse and Mental Health Service Administration (SAMHSA) concluded that “the data confirmed a correlation between increased methadone distribution through pharmacy channels and a rise in methadone associated mortality. This supports the hypothesis that the growing use of methadone, prescribed and dispensed, for the outpatient management of chronic pain, explains the dramatic increases in methadone consumption and the growing availability of the drug from diversion and abuse.”

Because of its potential for misuse, federal regulations require methadone for opioid use disorder to be prescribed and dispensed in highly structured OTPs. These regulations help protect patients on their recovery journeys, ensure appropriate provider oversight, and prevent the selling, sharing, or misuse of the powerful narcotic in communities.

Some organizations — and members of Congress — believe the overdose crisis can be solved by reducing opioid addiction treatment to just prescribing methadone without any of the consumer or community protections built into the OTP regulations.

In early 2022, Senators Ed Markey (D-Mass.) and Rand Paul (R-Ky.) introduced the Opioid Treatment Access Act of 2022, a bill aimed at expanding access to opioid treatment. While the legislation contains some provisions to do just that — like removing duplicative registration requirements for mobile clinics and codifying methadone take-home flexibilities for patients — Section 4 of the bill is a step backward. It would allow methadone to be dispensed at neighborhood pharmacies with no oversight or diversion control mechanisms, putting patients and communities at risk for even greater overdose and misuse.

Section 4 of the act is a knee-jerk reaction in response to the mounting pressure on Congress to do something to address the opioid crisis. Broadly deregulating methadone prescribing, however, completely disregards the proven value of behavioral counseling in opioid addiction treatment. And seminal research has demonstrated that psychosocial services provided as part of comprehensive medication-assisted therapy are critical for ensuring patients remain engaged in their recovery process and continually return to receive care.

Opioid treatment programs have successfully adhered to evidence-based federal and state regulations and, as a result, are widely recognized as the gold standard of addiction care with unmatched patient recovery success. Yet when leaders of these programs express concerns about opening the floodgates for unregulated methadone prescriptions, a few members of Congress and one physician trade association are quick to write off these programs as self-interested businesses. This couldn’t be further from the truth. No other provider group better understands the nuances of severe opioid addiction and the whole-person approach to care that has been proven to give people the best chance at long-term recovery.

In the push to reform addiction treatment policies, there’s a false assertion being made that other countries are successfully rolling out unsupervised methadone dispensing at neighborhood pharmacies. The data don’t support these claims. A study in Canada shows that individuals receiving methadone from an opioid treatment program were more likely to stay in treatment, with a one-year retention rate of 57.3% compared to just 11.9% for those receiving methadone at an offsite pharmacy. This model isn’t the solution if the people who need treatment most don’t come back.

SAMHSA recently released draft regulations that will significantly expand access to life-saving care delivered by opioid treatment programs. These regulations, once implemented, will allow telehealth access to these programs and safely increase access to take-home medication. Congress must understand that policymaking in this complicated arena requires working with experts in the trenches and regulatory agencies that rely on evidence to appreciate the critical balancing act between increasing access and consumer and community protections.

If Congress requires dangerous policy changes without expert input, more people across the country will needlessly die of overdoses. Opioid treatment programs have long advocated for low-cost, evidence-based policy changes that would dramatically increase access to medication-assisted treatment while also reducing the dangerous unintended consequences of unsupervised methadone entering communities and exacerbating the overdose epidemic.

Opioid treatment programs understand the high stakes of the opioid epidemic better than anyone. And while many people opine about how to solve the opioid epidemic, policymakers and advocates need to pay attention to recommendations of the people who work day in and day out caring for people with opioid use disorder. The focus should be on optimizing the health care system, not watering down what’s known to work while simultaneously putting individuals and communities at risk.

Section 4 of the Opioid Treatment Access Act is short-sighted, and would unravel the progress that has been made in the fight against opioid overdoses. Congress must work with OTPs to enact evidence-based solutions that ensure every American seeking recovery can access comprehensive medication-assisted treatment.

Jason Kletter is an organizational psychologist, president of BayMark Health Services; president of the California Opioid Maintenance Providers group; and serves on the board, and as legislative committee chair, of the American Association for the Treatment of Opioid Dependence.

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