Researchers say regulations that limit patient access to methadone may have contributed to a significant decline in supplies of the opioid use disorder medication within the US since the beginning of the pandemic.
The nation’s supply of methadone per capita fell 20% in the second quarter of 2020 compared to the first quarter of that year, marking the biggest decrease over the last decade, according to the findings of an analysis published Tuesday JAMA Network Open.
The study examined data tracking the commercial distribution of methadone, as well as the other most commonly used medication for treating opioid use disorder, buprenorphine, from Jan. 1, 2012 through June 30, 2021 to compare supplies of both drugs before and during the COVID-19.
While the per capita supply of buprenorphine has remained stable throughout the last decade, increasing by 7% from the first quarter of 2020 through June of 2021, methadone supplies have had more fluctuations.
Previously, the methadone supply had decreased significantly during the fourth quarter of 2016, when it declined 14%, and again in 2018, when it dropped by 13%, according to the study. However, in each instance supplies quickly recovered within the span of two quarters.
Addiction Amid COVID-19
The most recent decline in 2020 is unique in that per capita supplies of methadone had yet to recover as of June 2021, remaining below 2019 levels. The study found increases in the per capita supply of buprenorphine during the period examined were not enough to offset the decreases in the per capita supply of methadone.
“The fact that methadone decreased, has sort of stayed down, and doesn’t really seem to have been compensated by buprenorphine is something that sends up a red flag as far as if there is a problem in some places in ensuring that patients still have access to these effective interventions,” says study lead author Dr. Bradley Stein, a senior policy researcher and director of the Opioid Policies, Tools and Information Center at the RAND Corporation.
Reductions in the per capita methadone supply occurred across 35 states and the District of Columbia, with 16 experiencing a decrease of more than 10%, the study found. Many of the states with the largest decrease in methadone supply were located in the southern US The per capita supply of methadone in Alabama, Mississippi and Nebraska dropped by more than 30% compared to 2019 supply levels. Florida and New Hampshire both experienced the largest decreases at nearly 50%.
Increases in the per capita methadone supply did occur in 15 states, with Arizona, North Dakota, Kentucky, Delaware and Ohio all experiencing growth of more than 10%. By contrast, researchers found no substantial variation in the supply of buprenorphine across states.
State policies around ensuring patient access to methadone during the pandemic may have had an impact on their per capita supplies. Some states in response to the pandemic implemented programs to lessen access disruptions, such as allowing for curbside pickup of medications, allowing family members to pick up doses, and relaxing rules around taking home methadone.
Stein, however, stresses further investigation is needed to discover what impact, if any, state policies may have had on methadone supplies.
“We’re going to go back to the data and see if looking at the data can help us understand what were the impacts of some of these state policies,” Stein says.
Stein says it is also not yet clear what factors contributed to the steady overall decline in the per capita methadone supply. He speculates a potential explanation may be at least partly related to the tougher regulatory requirements for patients to access methadone compared to the rules around distributing buprenorphine.
Methadone can only be dispensed by one of nearly 2,000 opioid treatment programs Certified by the Substance Abuse and Mental Health Services Administration. Rules historically required most methadone patients to visit a treatment program daily to receive a dose that was monitored by clinic staff. Such requirements have been relaxed during the pandemic, in which patients are deemed stable are allowed to take more doses of methadone home without supervision. But new patients are still required to visit a clinic in person to start a prescription.
The requirements around distributing methadone made access to methadone even tougher for patients, especially during the pandemic’s early months. A previous JAMA Network study examining access to methadone from May through June of 2020 at nearly 300 clinics across 13 states, the District of Columbia, and three provinces in Canada found that more than 1 in 10 providers did not accept new patients, with one-third of those reporting facilities it was due to COVID-19.
“Just because policies were relaxed doesn’t mean that all clinics changed what was going on in the clinic to take advantage of those relaxed policies,” Stein says.
By contrast, there has been a much more concerted effort by government regulators to expand access to buprenorphine for years. Prior to the pandemic, buprenorphine could be prescribed by any clinician who received a wave to dispense the medication to a specified number of patients. In response to COVID-19, in April 2021, the US Department of Health and Human Services released new practicing guidelines that exempt most health care professionals from certification requirements to obtain a waiver, which allows them to prescribe buprenorphine to up to 30 patients.
“There are lots of factors related to the regulations around the use of methadone and buprenorphine, and I think there’s a lot of conversation about whether those should be re-visited and both the potential benefits and unintended consequences of doing so,” Stein says.
The study’s findings are the latest evidence to highlight the large gap that exists between the demand for opioid use disorder treatment and the number of Americans who actually receive it.
“It comes down to whether patients can receive the medication that can help them with their opioid use disorder,” Stein says. “This certainly is something that suggests we need to keep an eye on what happened during the pandemic and then what is continuing to happen to ensure that individuals with opioid use disorder are able to easily access these medications that are the gold standard treatment.”