Easing prescription rules for opioid treatment drugs did not increase overdose deaths, study finds

A new study shows that easing restrictions on buprenorphine, a drug that can treat opioid use disorder, did not lead to an increase in overdose deaths involving the treatment. The findings could help allay concerns that making buprenorphine more widely available could lead to more overdose deaths.

Buprenorphine and similar medications, such as methadone and Suboxone, are opioid agonists that reduce withdrawal symptoms and cravings. Compared to methadone, buprenorphine has a lower potential for abuse and overdose, making it the most accessible of all the options, but it remains “significantly underused,” the study said.

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 addiction. 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 to.

During the coronavirus pandemic, federal rule changes allowed qualified clinicians externally prescribe buprenorphine, even for new patients, removes a requirement for personal evaluation. This change will remain in place until the public health emergency declared in April 2020 is ended by the federal government.

To determine the impact 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, to June 2021, after about 15 months of the new policy. Of these 89,111 overdose deaths, 74,474 involved opioids.

Of opioid-related deaths, only 1,995 cases involved buprenorphine. In total, buprenorphine was found in 2.2% of all overdose deaths and 2.6% of opioid-involved overdose deaths.

Despite an increase in overdose deaths from 2019 to 2021, buprenorphine overdose deaths did not increase. There were some fluctuations between July 2019 and June 2021, but death rates either decreased or remained stable, the researchers found.

“Our findings suggest that expanded prescribing was not associated with a disproportionate number of deaths involving buprenorphine,” said researchers in the study, which was a collaboration between the National Institute on Drug Abuse and the Centers for Disease Control and Prevention.

“Nevertheless, although rare, overdose deaths involving buprenorphine highlight the importance of overdose prevention and support for those using buprenorphine both under medical supervision and outside of treatment for SUD [substance use disorder] or pain,” they wrote.

The researchers also said that more equitable access to the drugs 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 who were receiving treatment for opioid use disorder at the time of their death, and even fewer — about 20% — were taking medication specifically to help with the problem.

Only 3.2% of people who died from opioid overdoses received treatment at the time.

This “strong 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 big 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 looked at this issue, and found that while there may be some abuse, 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 previous research, concluded that people were unlikely to abuse 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, methadone patients must go to clinics daily to get their dose, but during the pandemic, patients were allowed to receive up to a month’s supply of medication at a time.

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