FDA Contracts With NASEM to Develop Opioid Rx Guidelines

Dentistry Today


The Food and Drug Administration (FDA) has contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop evidence-based guidelines for opioid prescriptions. NASEM will aim to understand what evidence is needed to ensure that these guidelines are sufficient as well as what research will be needed to generate that evidence. 

“This work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices,” said FDA commissioner Scott Gottlieb, MD.

NASEM’s work will include a review of current opioid guidelines, exploring how they were developed, what gaps in evidence they may have, and what research will be needed to fill in those gaps. The organization also will host a series of meetings and public workshops to gather knowledge and emerging evidence from a broad range of stakeholders related to the development and availability of guidelines based on their specialties.

“We acknowledge the work of our colleagues at the US Centers for Disease Control and Prevention (CDC) who have taken an initial step in developing federal guidelines on pain management and the use of opioids which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed,” said Gottlieb. 

“The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific, and would be based on prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain. Our work could potentially inform drug labelling. These two efforts are highly complementary and serve adjacent goals,” Gottlieb said.

For example, FDA analyses suggest that clinicians may prescribe far fewer pills at first for many common acute indications, such as a day or two of medication instead of a 30-day supply. This would reduce the number of pills that could be misused by patients, diverted to illicit markets, or abused by friends or family members.

“Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids. And too many prescriptions are written for longer durations of use than are appropriate for the medical need being addressed,” Gottlieb said. 

“That’s why it’s important that we reexamine how opioid analgesics are being prescribed when deemed an appropriate course of treatment. And it’s why we have to arm healthcare providers, who are the gatekeepers to prescription opioid analgesics, with the most current and comprehensive guidance on the appropriate management of pain,” Gottlieb said.

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