A new study shows that reducing restrictions on buprenorphine, a medication that can treat opioid use disorder, did not lead to an increase in overdose deaths involving the treatment. The findings may help allay concerns that making buprenorphine more widely available could lead to more overdose deaths.
Buprenorphine and similar medications, like methadone and Suboxone, are opioid agonists that reduce withdrawal symptoms and cravings. Compared to methadone, buprenorphine has a lower potential for misuse and overdose, making it the most accessible of all the options, but it remains “substantially underused,” the study says.
There are restrictions on who can prescribe buprenorphine and where it can be obtained. It remains classified as a Schedule III controlled substance, meaning one with a moderate to low risk of dependence. Previously, buprenorphine had to be prescribed in a clinical setting by a prescriber registered with the Drug Enforcement Administration. Recent policy changes have removed the requirement commonly known as the “X waiver,” which had limited how many patients a provider could prescribe buprenorphine for.
During the coronavirus pandemic, federal rule changes allowed qualified clinicians tobuprenorphine, even to new patients, removing a requirement for in-person evaluations. That change will remain in place until the public health emergency declared in April 2020 is ended by the federal government.
To determine the effect of these policy changes, the federal researchers who conducted the study looked at 89,111 overdose deaths reported by 32 jurisdictions from July 2019, before the changes began, until June 2021, after about 15 months of the new policy. Of those 89,111 overdose deaths, 74,474 involved opioids.
Of the opioid-related deaths, just 1,995 cases involved buprenorphine. In total, buprenorphine was found in 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.
Despite an increase infrom 2019 to 2021, buprenorphine overdose deaths did not increase. There was some fluctuation between July 2019 and June 2021, but death rates either decreased or stayed stable, the researchers found.
“Our findings suggest that expanded prescribing was not associated with a disproportionate number of deaths involving buprenorphine,” researchers said in the study, which was was a collaborative effort between the National Institute on Drug Abuse and the Centers for Disease Control and Prevention.
“Nonetheless, although rare, overdose deaths involving buprenorphine highlight the importance of overdose prevention and support for those using buprenorphine both under medical supervision or outside of treatment for SUD [substance use disorder] or pain,” they wrote.
The researchers also said that more equitable access to the medications and other “harm reduction strategies” are needed to help address the overdose crisis.
Another finding of the study was that less than a quarter of buprenorphine-involved overdose deaths were people receiving treatment for opioid use disorder at the time of their death, and even fewer — about 20% — were specifically taking medications to help with the problem.
Only 3.2% of people who died of opioid overdoses were receiving treatment at the time.
This “stark finding,” researchers said, highlights “the need to expand access to evidence-based treatment, particularly medications for OUD; improve treatment retention; and support long-term recovery.”
A major part of why buprenorphine has had restrictions is the concern that it could be “diverted,” or given by the person receiving the prescription to someone else. The study did look at this issue, and found that while there may be some misuse, it was likely because people were trying to “suppress withdrawal and self-treat” their addiction “in the absence of formal treatment access.” This study, along with prior research, concluded that it was unlikely that people were misusing buprenorphine to experience a “high.”
The researchers said their findings were consistent with a 2022 study that reported no association between COVID-era prescribing flexibility for methadone-based treatment and methadone-involved overdose deaths. In most cases, patients who use methadone have to go to clinics daily for their dose, but during the pandemic patients were allowed to receive up to one month’s supply of the medication at a time.