Markey, Paul Aim to Get Methadone Treatment for Opioid Use Disorder Into Pharmacies
WASHINGTON — Sens. Ed Markey, D-Mass., and Rand Paul, R-Ky., in February introduced a bill which would revise outdated regulations on methadone treatment and allow any pharmacy to dispense methadone for treating opioid use disorders.
The bill has since been referred to the Senate’s Committee on Health, Education, Labor, and Pensions.
“The Opioid Treatment Access Act would reduce restrictions on how long and where addiction treatment specialists can prescribe take-home methadone for patients in recovery, eliminating decades-old regulations that were based in racism and stigma. We must do everything we can to get patients the treatment they need,” said Markey, in an email to The Well News.
Under the Controlled Substances Act, methadone and buprenorphine are opioids approved for treatment of opioid use disorder from federally-certified opioid treatment programs, often called methadone clinics.
Evidence from the National Institute on Drug Abuse shows that methadone and buprenorphine reduce opioid use disorder-related symptoms, opioid use, the risk of infectious disease transmission and criminal behavior associated with drug use.
Patients on methadone had 33% fewer opioid-positive drug tests and were 4.44 times more likely to stay in treatment compared to controls, even in the absence of counseling services, according to the evidence.
In almost all circumstances, these medication-assisted treatments can only be offered at methadone clinics and those clinics are not often located in rural areas.
“Opioid Treatment Programs tend to be established in urban areas. SAMHSA supports the options of people who have opioid use disorder who have been dispensed methadone to access their care via opioid treatment programs or a corresponding mobile unit,” said a spokesperson from the Substance Abuse and Mental Health Services Administration, in an email to The Well News.
Both the House and Senate bills, which have identical language, would allow mobile sites to dispense treatment, instead of only federally-certified methadone clinics.
“The priority is in connecting people to evidence-based treatments and supports that are proven to help people pursue and attain recovery. The addition of mobile units may allow an opioid treatment program to service larger areas, thereby reaching more people who need treatment,” said the SAMHSA spokesperson.
The bill would build on some of SAMHSA’s COVID-19 exemptions that were granted to allow patients to receive longer take-home supplies of methadone.
It would also direct SAMHSA to conduct national research to study existing and current regulatory flexibilities on accessing treatment.
From 1970-2001, the U.S. Food and Drug Administration regulated methadone treatment programs. Under the FDA rules, a person in treatment was required to treat at methadone clinics for three years before they could receive a monthly take-home methadone dose.
In 2001, SAMHSA took over methadone regulations and eventually changed the federal rules to allow for a monthly take-home methadone dose after two years of treatment.
Under the public health emergency declared by the Health and Human Services secretary in relation to the COVID-19 pandemic, SAMHSA allowed methadone clinics to dispense 28 days of take-home methadone doses to stable patients for the treatment of opioid use disorder.
The order also allowed for up to 14 doses of take-home methadone for less-stable patients, allowing treatment specialists at methadone clinics to determine whether they can safely handle the level of take-home medication.
Once the public emergency period ends, SAMHSA will extend these regulatory regulations for a year, but after that they are set to expire.
A study which examines the relaxation of methadone take-home protocols during the COVID-era shows that patients having access to larger quantities of methadone increases engagement with treatment, with only a few reported incidents of misuse.
One of the individuals who helped to draft the bill, Zachary Talbott, said during a phone call with The Well News that the bill would allow for a greater relaxation in treatment protocols for accessing take-home methadone.
“Under the federal rules you have to be in treatment for two years before you can have a monthly take-home [of methadone]. It’s arbitrary, there is no objective evidence,” said Talbott, who serves as president and chairman of the board of the National Alliance for Medication Assisted Recovery.
The bill would allow certain prescribers up to one month of take-home doses to be dispensed at a pharmacy and permit certain aspects of the care to be conducted via telehealth.
The timeline surrounding the early federal rule-setting for take-home methadone treatment overlaps with the two times in history that methadone toxicity was overrunning hospitals and emergency departments.
The first was in the 60s-70s when methadone received full approval for treatment under the FDA.
The second rise of methadone mortality was in the early 2000s due to steep increases in the prescribing of methadone for pain, especially in states where methadone was on the Medicaid preferred drug list, according to data from the Centers for Disease Control and Prevention and Department of Health and Human Services.
Talbott said that multiple studies show the rise of opioid overdoses related to methadone came from private prescriptions for pain and not from methadone dispensed from opioid treatment programs.
In 2008, the DEA restricted 40mg methadone tablets to the detoxification and maintenance of opioid addiction but continued to allow pharmacies to dispense 5mg and 10mg formulations for the treatment of pain.
“We can’t ignore that history, but at the same time… there is no data to suggest that letting patients move beyond the opioid treatment program system would cause harm,” said Talbott.
A brief on a Government Accountability Office report from 2009 — which examines methadone-related deaths — also found that a lack of knowledge about the “unique pharmacological properties” of methadone among prescribing physicians and patients contributed to the problem at the time.
“This is why there is provision of the Opioid Treatment Access Act that ensures any practitioners who utilize methadone for opioid use disorder are trained and have specialty knowledge and/or experience,” said Talbott.
Unlike methadone, buprenorphine is a partial opioid agonist, meaning that it is less dangerous and addictive. A physician may obtain a waiver to treat opioid addiction with buprenorphine under the Drug Addiction Treatment Act of 2000.
In 2019, 67 of these waivers were obtained, according to a report from the Congressional Research Service.
“We are just now getting emergency physicians to start undertaking buprenorphine because its safety profile is much higher… [but] primary care physicians cannot usually participate in the initiation of methadone,” said Dr. Shawn Ryan, co-founder, president and chief medical officer of Brightview Health, during a phone call with The Well News.
Brightview Health is a multi-state outpatient addiction treatment organization, and Ryan oversees a large network of opioid treatment program providers across territories where there is incongruity.
Ryan said there is a need for greater federal guidance and regulatory consistency throughout the field, as so much of the ability to distribute these medications depends on the state and regulatory frameworks, and how the provider interprets the opioid treatment program rights.
“Most providers don’t even know where to send someone. And then, when they do send them somewhere…the patient often slips through the cracks,” said Ryan.
The bill would emphasize that states should align their regulation of opioid treatment programs in a way that is consistent with the intent of the legislation to break down barriers of care.
Ryan said that the pandemic allowed for a “forced experimentation,” surrounding methadone take-home protocols in a way that never occurred in the field.
“Depending on how much data we can collect from different opioid treatment programs systems, we may be actually able to find [a system] which balances the pros and cons… We haven’t done that at scale in this field, and we haven’t given the physicians a lot of ability to make that determination,” said Ryan.
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