The five Massachusetts opioid treatment clinics where Ruth Potee works bend over backward to make methadone treatment easy and accessible for the people they serve. But Potee worries it isn’t enough.
The clinics have doctors on hand 12 hours a day to start new patients on methadone, which is considered the gold standard for opioid use disorder treatment. When possible, they send eligible patients home with the maximum number of take-home doses allowed under the law, rather than having them come to the clinic every day for supervised doses.
But not everyone is able to make the frequent trip to an opioid treatment center — a federal requirement that people with opioid use disorder must adhere to in order to receive methadone, a drug that can reduce the risk of overdose deaths by 50 percent.
It’s that group that Potee, an addiction services specialist, worries about. She and others argue methadone should be made more broadly available, prescribed by physicians and dispensed at pharmacies.
“It’s a miracle medicine — methadone saves lives,” Potee said. “It is one of the most effective treatments I’ve ever used in my 25-year career, and people don’t have access to it.”
Under federal law, methadone for the treatment of opioid use disorder is only available at 1,700 federally regulated opioid treatment programs, also called OTPs or methadone clinics.
But 80 percent of U.S. counties have no OTP, according to the Congressional Research Service, meaning patients often have to make lengthy journeys regularly to get the treatment that can save their life.
While the Biden administration, building off a pandemic-era flexibility that temporarily loosened the restrictions on take-home methadone doses, has proposed a rule that would reduce the number of days patients need to appear at an OTP to receive methadone, not all OTPs and states have embraced the idea.
“If every clinic were even as flexible as they could be, still people would not have access because the distances are too great,” Potee said. “Just the geography alone makes having this available in a pharmacy an absolute necessity.”
Addiction doctors and policymakers argue that with overdose deaths increasing and the illicit drug supply becoming deadlier, the U.S. can no longer afford to put such strict limits on a life-saving drug.
In Congress, Rep. Donald Norcross, D-N.J. and Sen. Edward J. Markey, D-Mass., have sponsored legislation that would allow physicians and psychiatrists board-certified in addiction medicine to prescribe methadone from their offices. They hope that such a move would expand the number of access points for patients seeking treatment.
They want the bill to be included in a forthcoming reauthorization of a 2018 law aimed at addressing the opioid crisis.
Clinics push back
But the measure faces pushback from some OTPs and the trade organization representing them.
“I understand why legislators and proponents think this is a good idea, but they are flirting with danger,” said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, a trade association representing OTPs.
He argues that such a move would lead to more methadone overdoses and diversion because physicians would be more likely to allow take-home doses, and said those offices are not equipped to provide the counseling and other services OTPs provide.
But addiction doctors, experts and the lawmakers argue OTPs have a business interest in ensuring they are the only ones who can dispense methadone. While they acknowledge methadone can be addictive and dangerous if taken improperly, they say it’s an effective treatment for opioid use disorder because it is slower-acting and its effects are less euphoric.
About 62 percent OTPs are operated by private for-profit facilities, according to the Substance Abuse and Mental Health Services Administration.
Norcross said the debate has become so heated that he cut off communications with the American Association for the Treatment of Opioid Dependence after two years of negotiations.
“They have become very aggressive in trying to defeat this,” Norcross said in an interview, adding that he had changed the legislation to try to get their support. “It’s nothing short of a national embarrassment where a cartel of OTPs have come together and are causing people the inability to get life-saving drugs.”
Norcross said he was “very close” to having the legislation included in the House Energy and Commerce Committee’s reauthorization of the 2018 law but leadership deferred to the American Association for the Treatment of Opioid Dependence.
There are higher hopes for Senate action, with Markey serving on the committee with jurisdiction over reauthorization of the law.
Several members of the Health, Education, Labor and Pensions Committee, including Chairman Bernie Sanders, I-Vt., have also co-sponsored the legislation.
While the committee has not released reauthorization legislation or scheduled a markup, Sanders said it is “something we’re going to look at.”
Increasing overdose deaths
In recent years, increases in drug overdoses have been driven by a deadlier illicit drug supply dominated by fentanyl.
An estimated 112,000 people died of drug overdoses in the 12-month period ending in May — an increase of 2.5 percent from the previous year, according to data from the Centers for Disease Control and Prevention.
Despite that, only 14 percent of people with opioid use disorder receive medication treatment like methadone, in part, said Nora Volkow, director of the National Institute on Drug Abuse, because there are not enough OTPs in the U.S. to treat the millions of people who need it.
“There are multiple barriers to access that is not justified based on what we know,” she said. “It would be very helpful for physicians to prescribe methadone. Other countries have been doing that for years.”
The United States is unique in its requirement that methadone only be dispensed by federally certified and highly regulated facilities; countries including Australia, Great Britain and Canada allow primary care physicians to prescribe methadone.
The current structure was set up by a 1974 law and it hasn’t changed much since. Methadone treatment typically requires patients to visit OTPs daily to receive their medications until they can prove they are “stable.”
While physicians in the United States can prescribe buprenorphine, another opioid use disorder treatment, methadone can be more useful at preventing fentanyl withdrawal symptoms.
But physicians in office-based settings have no choice but to refer patients to OTPs for methadone.
“More and more patients are interested in methadone, but the methadone rules make it more difficult to access,” said Michael Fingerhood, director of the division of addiction medicine at Johns Hopkins Medicine.
While there are many reasons someone might not receive treatment, experts say the restrictive nature of methadone treatment, which typically requires people to travel daily to clinics, at least for the first few months, has not helped.
The mean driving distance to an OTP is about 20 minutes one-way, and 37 minutes for people living in rural counties.
The longest drive was nearly two hours.
And there are no OTPs in Wyoming.
Studies have shown drive times longer than 10 minutes can reduce treatment completion rates.
“Many people simply cannot be driving 30 miles round trip every morning to get the medication they need to take care of their children, to go to work, to school — I would not be able to fit that into my life,” said Frances McGaffey, associate manager of substance use prevention and treatment at The Pew Charitable Trusts.
But a campaign called “Program, Not a Pill,” argues that allowing other physicians to prescribe methadone would disconnect treatment from programming that OTPs provide, like counseling.
“It’s not the expertise of the prescriber that is in question — there’s no doubt that they should be experts in understanding the disease,” said Jason Kletter, the leader of the campaign and the president of BayMark Health Services, a network of opioid treatment programs. “It’s the lack of resources in the private practice settings to engage with the patients on a regular basis.”
The American Association for the Treatment of Opioid Dependence and others argue access can be expanded through mobile vans that travel daily into communities and the proposed Substance Abuse and Mental Health Services Administration rule that would allow more take-home doses.
There are currently 33 vans across the country, according to SAMHSA data.
The association also argues that allowing board-certified addiction physicians to prescribe methadone will increase diversion and overdoses, and point to five federal agency studies issued in the early 2000s finding the majority of methadone deaths were attributed to physicians prescribing the drug in private practices.
But supporters said those studies took place at a time when physicians were widely overprescribing opioids, including methadone, for pain.
The National Academy of Sciences concluded in a 2019 report that restricting methadone prescribing to OTPs is “not supported by evidence,” pointing to several studies from the U.S. and other countries showing physicians can prescribe methadone with similar patient outcomes.
Board-certified addiction professionals are capable of treating their patients in a way that minimizes diversion or overdoses, said Brian Hurley, president of the American Society of Addiction Medicine.
“If I have a patient that I am concerned may not take medication as prescribed, whether it’s methadone or not, I can still send them to a pharmacy to pick it up daily,” he said.
“It isn’t like this creates a pathway to methadone that is really unusual. It just dramatically increases the number of potential pickup spots.”
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