NASEM Report Provides Framework for Developing Opioid Prescribing Guidelines

In an effort to further address the current opioid crisis, the FDA contracted the NASEM to examine existing opioid prescribing guidelines and to help outline the type of research needed to fill the gaps in evidence.

The National Academies of Sciences, Engineering, and Medicine (NASEM) has issued a consensus report that provides recommendations for structuring future clinical practice guidelines on appropriate opioid prescribing for acute pain.

In an effort to further address the current opioid crisis, the Food and Drug Administration (FDA) contracted the NASEM to examine existing opioid prescribing guidelines and to help outline the type of research needed to fill the gaps in evidence. In their report, the NASEM committee makes several recommendations for developing a framework that can be used to develop evidence-based guidelines for opioid prescribing. Some of these recommendations include:

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  • Explicitly stating the patient population for which the guideline is applicable and the subpopulations for which the recommendations may need to be modified.
  • Using a standardized method when describing opioid prescribing strategies; morphine milligram equivalents (MMEs) could help with evaluating different opioids based on potency.
  • Examining both short- and long-term health outcomes (ie, pain, function, quality of life, morbidity/mortality) associated with opioid prescribing for acute pain and using appropriate study design to investigate these health outcomes and how they are linked to specific opioid prescribing strategies.
  • Establishing a process for disseminating and implementing new guidelines in addition to monitoring the impact of these guidelines on health outcomes, opioid misuse and abuse, as well as opioid-related deaths.
  • Addressing the appropriate use of opioids based on the indication and explicitly stating opioid alternatives (ie, acetaminophen, NSAIDs) as first-line therapies when indicated. 
  • Specifying which nonopioid interventions were used to relieve pain in addition to the opioid prescribing strategies being evaluated.

According to the NASEM, an extensive review of studies evaluating opioid prescribing for acute pain showed that very few specifically addressed the societal impact of opioid prescribing strategies. “While it seems intuitive that reducing opioid prescribing may result in fewer opioid overdoses and deaths, the impact of such reductions on patient pain control and the risk of unintended consequences for patients, their support systems, and their communities cannot be assumed and should be informed by accurate and comprehensive data,” the panel stated in the report. To address these gaps, the NASEM recommended that future research should take into account key patient populations, the impact of the clinical setting, and the link between intermediate outcomes (ie, amount used/unused, refill requests, misuse, diversion) and health outcomes.

“Moving forward, the FDA will consider the recommendations included in the consensus report as the agency works to implement the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) provision that requires the development of evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist,” the Agency stated in a press release.

For more information visit nap.edu.

This article originally appeared on MPR