WASHINGTON — When it comes to fighting opioid addiction, there’s no tool more effective than methadone. Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose.
But for decades, an archaic web of federal regulations has kept the medication out of reach for countless Americans. Physicians aren’t allowed to prescribe the drug directly to patients. Pharmacies aren’t allowed to dispense it. Patients who want methadone are often required to show up at a designated facility every day — sometimes at the crack of dawn — just to receive a single dose.
Now, amid a worsening addiction crisis, experts are urging the government to eliminate many of the restrictions surrounding methadone use. Keeping the current rules in place, they argue, probably costs thousands of lives each year.
“There’s momentum — there’s a lot of interest in expanding access to methadone via responsible dispensing,” said Regina LaBelle, a drug policy expert at Georgetown University and the former acting director of the Office of National Drug Control Policy. “Sometimes, it’s been so restricted it’s almost seen as a punishment.”
The debate surrounding methadone access highlights the urgency of the U.S. addiction crisis, and the fragmented nature of the country’s system for treating substance use. Over 100,000 Americans are dying of overdose each year, according to the Centers for Disease Control and Prevention — and roughly three-quarters of those deaths involve opioids.
Still, medications known to significantly reduce someone’s odds of overdose death remain vastly underutilized. Just a fraction of the roughly 3 million Americans with opioid use disorder are undergoing what’s known as medication-assisted treatment, or MAT — with medicines that help combat cravings and withdrawal symptoms, thereby helping people reduce their illicit drug use or stop altogether.
Those drugs are highly effective: Methadone has been shown to reduce the odds of overdose death by 59%, and another common drug, buprenorphine, has been shown to reduce the odds of a fatal overdose by 38%.
Yet methadone, in particular, remains highly restricted in part because the Drug Enforcement Administration classifies it as a controlled substance. The drug is, itself, an opioid, and it is also approved for use as a painkiller, leading some officials to fear that increasing access could lead to misuse or overdose.
Experts argue, however, that the benefits of methadone as an addiction treatment substantially outweigh any risks — and that federal officials have the authority to quickly unravel a web of decades-old, highly restrictive policies.
“Evidence shows it reduces overdose deaths, illicit opioid use, transmission of infectious diseases, and criminal justice outcomes,” said Sheri Doyle, a senior manager for the Pew Charitable Trusts’ substance use prevention and treatment initiative. “We believe there are a number of key actions the administration can take to support methadone use for opioid use disorder.”
According to a new Pew-funded report, by researchers at George Washington University, the federal government can expand methadone access without approval from Congress.
The report focuses on two key agencies: the Drug Enforcement Administration, and the Substance Abuse and Mental Health Services Administration. Both agencies could greatly expand methadone access by waiving several longstanding restrictions, according to the report’s authors, Bridget Dooling and Laura Stanley.
Among other actions, the report suggests that the DEA could eliminate its de facto ban on doctors prescribing methadone like any other medication, allowing patients to pick it up at a pharmacy instead of receiving their daily dose at an opioid treatment program, or OTP. Reclassifying methadone as a Schedule III drug, instead of Schedule II, would also make it easier for physicians to prescribe the drug directly, the authors wrote.
The report also proposes that SAMHSA eliminate its requirement that patients be addicted to opioids for a full year prior to beginning methadone treatment, and requirements that force patients to undergo regular testing for illicit opioids, like heroin.
Some of the report’s recommendations are already in place — at least temporarily. During the Covid-19 pandemic, the government moved quickly to relax restrictions on addiction medication. In early 2020, federal officials let patients access buprenorphine via telemedicine and eliminated the requirement that patients taking methadone show up daily at an OTP. Instead, in an effort to promote social distancing, it allowed those deemed “stable” to take home weeks’ worth of the drug.
Research now shows that the new allowances did not lead to an increase in misuse or overdose.
The GW report, Doyle argued, shows that SAMHSA and the DEA have “incredible authority” to loosen regulations and increase access to methadone.
It also highlights a double standard between methadone and other forms of addiction treatment, she said. Buprenorphine, for instance, can be prescribed by any provider who has obtained a special waiver, and can be dispensed at a pharmacy.
There’s even a double standard for methadone itself. Patients who want to use methadone as an addiction treatment have to jump through countless hoops, like verifying they’ve been experiencing addiction for at least a year, frequent drug testing, and daily visits to OTPs. But for patients using methadone as a painkiller, none of those restrictions apply.
The stringent rules surrounding methadone as an addiction treatment also pose an equity issue, Doyle said.
“People of color end up facing more stringent requirements because OTPs are more likely to be located in segregated counties that have more Black and Hispanic residents, and thus a higher capacity to provide methadone over buprenorphine,” she said. In other words: Patients from historically marginalized backgrounds are often funneled toward being treated with methadone, as opposed to buprenorphine — meaning their course of treatment requires more time, effort, and stress.
In general, increasing access to medication-based treatment has been an uphill climb. As long as the drugs have existed, they’ve been dogged by stigma and the criticism that they simply “substitute one drug for another” — a view that Tom Price, President Trump’s former health secretary, controversially voiced as recently as 2017.
Given the magnitude of the crisis, advocates argue, it’s time for government agencies to move past the stigma.
To date, President Biden has shown enthusiasm for expanding access to MAT, even calling for “universal access” to the treatments, including methadone, by 2025. The administration’s recent proposals for expanding methadone access, however, are far less ambitious than the changes advocates like LaBelle and Doyle have argued for.
Miriam Delphin-Rittmon, the SAMHSA administrator, has said she supports allowing patients to take home weeks’ worth of methadone even once the Covid-19 pandemic ends. Meanwhile, the DEA has allowed methadone clinics to operate “mobile” facilities — namely, vans that distribute the drug in underserved neighborhoods — for the first time.
“We can’t just have this report and not do anything about it,” LaBelle said. “It’s urgent that the administration, that policymakers, look at the recommendations, seriously consider them, and put into action those that they can.”
This article was supported by a grant from Bloomberg Philanthropies.