Ever since the deadly synthetic opioid fentanyl began showing up in the illicit drug supply in 2014, the number of U.S. overdose deaths has skyrocketed — exceeding all other accidental deaths, including car crashes and gun violence.
In response, the federal government and some states are redoubling efforts to curb the epidemic of overdoses from opioid painkillers, heroin and fentanyl by making medication-assisted treatment more accessible to the estimated 9.5 million people with an opioid use disorder.
Last week, the federal Substance Abuse and Mental Health Services Administration proposed to make permanent pandemic-era rule changes that have allowed certain patients to take home up to a 28-day supply of the addiction medication methadone, instead of showing up for a daily dose at a crowded clinic.
But state drug and alcohol agencies and clinic operators will decide whether to adopt the new baseline rules or retain stricter state regulations. And those that opt for a more flexible approach will have to overcome the stigma, fear and misinformation about methadone that, for decades, has dogged patients who rely on the addiction medication and clinics that dispense it.
Unlike buprenorphine and naltrexone, the other two drugs approved by the U.S. Food and Drug Administration for the treatment of addiction, methadone has been required under federal law to be administered in person at clinics where long lines and full parking lots have caused resentment among neighbors and passersby. The new rules would allow patients who meet certain qualifications to take it at home for up to 28 days.
Advocates for people with addiction and the methadone industry have long sought the permanent rule changes proposed last week, which would allow more of the nation’s 476,000 methadone patients to take their daily dose in the privacy of their own homes.
In addition, a bipartisan bill in Congress, the Opioid Treatment Access Act, would take the administration’s liberalization of methadone rules a step further, allowing doctors to prescribe the powerful medication and pharmacies to dispense it.
Mark Parrino, who heads the methadone industry group the American Association for the Treatment of Opioid Dependence, applauded the new federal proposal. If states align their policies with the new recommendations, he said, it will “advance the work of our field in admitting patients to treatment and keeping them in treatment.”
Under current state statutes and rules, methadone clinics, known as opioid treatment programs or OTPs, are tightly regulated. In addition to a variety of costly security measures to ensure the addiction medication is not diverted to illicit markets, many states set limits on where clinics can be located and when they can operate.
Nineteen states and the District of Columbia require providers to prove sufficient need for a new treatment facility to be opened, and seven states and the District of Columbia impose zoning regulations that limit where clinics can be located, according to research by The Pew Charitable Trusts, a nonprofit based in Washington, D.C. (Pew also funds Stateline.)
“In recent years, we’ve seen some states taking another look at their OTP regulations to expand access to care and improve the patient experience,” said Frances McGaffey, who leads Pew’s research on how states regulate opioid treatment programs.
This year and last, Colorado, Kentucky, Massachusetts and New York moved to streamline state restrictions on clinics that made it difficult for patients to access their services, she said.
But prejudice and “not in my backyard” political pressures have made change difficult in some states. In West Virginia, for example, which has by far the highest overdose death rate in the country, an effort this year to repeal a 2007 moratorium on new methadone clinics failed to pass the legislature.
The Biden administration’s push for relaxed methadone rules comes on the heels of an industry survey released earlier this month showing that the number of patients taking methadone for an opioid addiction surged from 312,000 in 2020, to 476,000 in 2021.
In response to increasing demand, the number of opioid treatment programs grew to 1,963 this year, a 30% increase since 2018.
One reason for the spike in methadone use, according to the survey, conducted by the Association for the Treatment of Opioid Dependence and the National Association of State Alcohol and Drug Abuse Directors, may be the growing prevalence of fentanyl in the illicit drug supply.
Fifty times stronger than heroin, the synthetic opioid was responsible for two-thirds of the more than 107,000 overdose deaths last year. In addition to killing more people, fentanyl use may be making opioid addiction harder to treat using buprenorphine, which is not as strong a match for fentanyl.
“Initial indications are that methadone may be preferable in treating fentanyl to relieve withdrawal symptoms and cravings and retaining patients in treatment,” according to the survey.
Typically found added to heroin and other drugs, fentanyl became a staple in the illicit drug market in 2014, according to the U.S. Drug Enforcement Administration. And by 2016, it was killing more people than heroin, according to the federal Centers for Disease Control and Prevention.
Drug users, including casual recreational users, were mostly unaware of the powerful contaminant, and tens of thousands of people died.
But by 2019, fentanyl was replacing heroin in some parts of the country, and drug users reported intentional use of the cheaper, faster-acting drug, Stateline has reported.
The number of overdose deaths from all opioids spiked nearly 60% between January 2020 and 2021, according to the CDC. Both buprenorphine and methadone have been shown to save lives, reducing overdoses by up to 76% in the first three months of use compared with no treatment.
In proposing relaxed rules for methadone, the federal Substance Abuse and Mental Health Services Administration also proposed that clinicians continue to initiate patients on buprenorphine through a telehealth consultation instead of the pre-pandemic federal requirement that patients show up in person.
Unlike methadone, which presents a higher risk of overdose if used incorrectly and is tightly regulated by federal authorities, buprenorphine can be prescribed by doctors and advanced practice nurses and taken at home.
Dr. Andrew Kolodny, senior scientist at the Brandeis University Heller School for Social Policy and Management, who has long promoted the use of buprenorphine, said the safe and effective addiction drug is still considered the first line of treatment for most patients, including those who are using illicit fentanyl.
But in the past few years, he said, some addiction practitioners report having to adjust traditional protocols for initiating fentanyl patients on buprenorphine and, in some cases, have opted for methadone instead.
To avoid sudden withdrawal symptoms from residual fentanyl, which tends to stay in the body longer than other opioids, some practitioners are starting with a lower dose of buprenorphine and gradually moving to a higher dose, he said.
Patients with addictions to prescription painkillers or heroin start feeling better immediately after taking a first dose of buprenorphine. But for patients who have been using fentanyl regularly, Kolodny said, it may take a few days before they start feeling normal.
In some cases, that could result in fentanyl patients dropping out of treatment, he said. For some fentanyl users, methadone will more effectively relieve those cravings, Kolodny and other experts say. But for now, choosing methadone to treat an opioid addiction usually means commuting daily to a clinic.
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