Overdose Epidemic

Add flexibility on buprenorphine Rx for opioid-use disorder

Kevin B. O'Reilly , Senior News Editor

The nation’s worsening opioid-overdose epidemic has prompted the AMA to call for the elimination of dose-limit barriers to ensure adequate buprenorphine treatment for patients with opioid use disorder.

Now, patients and physicians encounter strict dose limits set by health insurers and other payers based on drug labels approved by the Food and Drug Administration (FDA) decades ago, when illicitly manufactured fentanyl and fentanyl analogues were not a major cause of mortality as it is today. Buprenorphine reduces the risk of fatal overdose, eases opioid withdrawal symptoms and cravings, and helps sustain recovery for patients with an opioid-use disorder.

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“Illicitly manufactured fentanyl and other synthetic opioids have created a far more dangerous and deadly epidemic in recent years, claiming more than 109,000 lives in 2022,” said Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force.

“As the drug-overdose epidemic evolves, health systems and insurers must adapt,” Dr. Mukkamala said. “Our colleagues in addiction medicine are seeing efficacy of using buprenorphine products at higher doses than the current FDA-approved labeling, but health insurers and others prevent patients from receiving this medication in a timely manner. Removing these outdated dosage caps will ensure physicians can prescribe life-saving medications without delay.”

To that effect, at the most recent AMA Interim Meeting, the House of Delegates adopted policy to:

  • Support patients’ ability to receive buprenorphine doses that exceed dosage limits listed in FDA-approved labeling when recommended by their prescriber for the treatment of opioid-use disorder.
  • Urge interested parties, including federal agencies, manufacturers, medical organizations, and health plans to review the evidence concerning buprenorphine dosing and revise labels and policies accordingly, in light of increasing mortality related to high-potency synthetic opioids.

There is already some forward momentum on the issue. Last month, the Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse and the FDA held a meeting with invited experts to “discuss medical need, emerging data and barriers to accessing high-dose buprenorphine in the context of high potency synthetic opioid exposure.”

Meanwhile, Washington state has taken action to allow physicians to “prescribe buprenorphine at up to 32 milligrams per day,” as noted in an issue brief from the Pew Charitable Trusts.

The AMA believes that science, evidence and compassion must continue to guide patient care and policy change as the nation’s opioid epidemic evolves into a more dangerous and complicated illicit drug overdose epidemic. Learn more at the AMA’s End the Epidemic website.