FDA, National Academies Examining Opioids for Acute Pain

FDA is looking for evidence-based ways to fight opioid addiction by reducing the flow of prescription opioid products into patients’ homes.

“Think of it as primary prevention. Think of it as preventing new addiction, new exposure, new potential risk,” said Douglas C. Throckmorton, deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research, during a February 4 workshop convened by the National Academies of Science, Engineering, and Medicine in Washington, D.C.

FDA has asked a National Academies committee to develop a framework for evaluating existing clinical practice guidelines on the prescribing of opioids to treat acute pain resulting from specific conditions or medical procedures. FDA also requested that the group identify acute pain conditions for which opioid prescribing guidelines are needed and outline a future research agenda for opioid use in acute pain.

Throckmorton said those activities will support “rational opioid prescribing” by clinicians and will assist FDA as it focuses on “appropriate packaging, appropriate dosing, duration, and labeling” for prescription opioid products.

FDA officials have said that responding to the opioid crisis is a top priority for the agency.

Federal data indicate that 11.4 million people misuse prescription opioids each year, and more than 130 people die each day from opioid-related overdoses.

Recent research suggests that more than half of patients who are prescribed opioids for a variety of surgical procedures don’t use all of the medication, and unused doses may remain in the home.

“Human nature is to hold on to them just in case,” Throckmorton said. “But we know that for opioids, having them available in the medicine cabinet, having them available for diversion ... has important negative health consequences.”

He said FDA is especially interested in targeted advice from the committee about where to start with prescribing and research recommendations.

Workshop panelist Joanna Starrels, internal medicine specialist at Albert Einstein College of Medicine in New York, said her department examined electronic medical record data last year for 368 visits that resulted in a new opioid prescription.

She said back, spine, and joint pain accounted for 75 percent of visits that included an acute pain condition. Starrels also noted that a substantial number of visits to internal medicine clinics involve postoperative pain or fractures.

Other panelists from a variety of clinical disciplines named musculoskeletal pain, headache, dental pain, and shingles as conditions for which opioids are commonly prescribed in their practice settings.

The committee will hold a second workshop before developing its recommendations and releasing them to FDA and the public.

Throckmorton emphasized that the committee’s review of evidence on opioid prescribing should acknowledge the necessity pain management.

“This will not be a success if we reduce opioids inappropriately to the level that patients are no longer receiving treatment for their pain,” he cautioned.

[This news story appears in the May 1, 2019, issue of AJHP.]