A Fine Balance: Report Aims to Combat Opioid Epidemic, Manage Pain

Megan Brooks

January 07, 2020

A new consensus report from the National Academies of Sciences, Engineering, and Medicine (NASEM) aims to address the US epidemic of opioid misuse and overdose while ensuring effective pain management.

The report outlines a two-part framework for developing evidence-based clinical practice guidelines (CPGs) for appropriate opioid prescribing for acute pain.

The authors recommend both an analytic framework and an evidence evaluation framework that medical professional societies; healthcare organizations; and state, national, and local agencies can use to develop CPGs for prescribing opioids to manage acute pain. 

The analytic framework describes the evidence that needs to be assessed before making an opioid prescribing recommendation; the intermediate outcomes of different prescribing strategies (such as refill requests, unused pills, misuse, or diversion); and health outcomes (such as pain relief, improved quality of life, adverse effects, morbidity, and mortality). The analytic framework also highlights gaps in the current evidence, suggesting potential areas for new research.

The evidence evaluation framework would then be used by the developers of the CPGs to grade the quality of existing evidence and the strength of recommendations they make.

"A standardized process for developing CPGs would provide trustworthy evidence-based criteria for prescribing opioids, help clinicians assess the potential risks and benefits of prescribing opioids, and identify areas where more evidence and research is needed," write the NASEM committee, chaired by Bernard Lo, MD, The Greenwall Foundation and University of California San Francisco.

"Right Size" Prescribing

The US Food and Drug Administration (FDA) contracted with NASEM to develop the framework, as part of ongoing efforts to address the current opioid crisis.

"The FDA’s efforts to address the opioid crisis must focus on encouraging 'right size' prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

"That’s why it’s important that we re-examine how opioid analgesics are being prescribed and help to ensure that healthcare providers — who are the gatekeepers to prescription opioid analgesics — are provided with the most current and comprehensive guidance on the appropriate management of pain," said Woodcock.

As part of its work, the committee examined existing opioid analgesic prescribing guidelines, identified gaps in the evidence base and outlined the type of research that's needed to fill these gaps.

The NASEM committee identified a number of priority surgical procedures and medical conditions for which evidence-based CPGs for opioid prescribing would be particularly helpful. These indications were selected based on their prevalence/frequency, and upon evidence of variation in prescribing opioids for them.

High-priority surgical procedures include cesarean delivery, total knee replacement, and wisdom tooth removal; and medical indications include low back pain, sickle cell disease, migraines, and kidney stones.

"For example, childbirth is the most common reason for hospital admission and C-section is the most common surgical procedure in the United States, but there are no evidence-based guidelines for opioid prescribing after cesarean or vaginal delivery," the authors note.

"In other common conditions, like low back pain, there is a lack of evidence that opioids are more effective for acute pain than nonopioid alternatives such as over-the-counter medications or physical therapy. In these situations, a trustworthy CPG can help clinicians relieve acute pain and reduce the risks of excessive prescribing of opioids," the report says.

Knowledge Gaps

Key gaps in knowledge identified by the committee, which they say need addressing via further research, include:

  • How nonopioid interventions affect the need for opioids and the outcomes of patients who have been prescribed opioids

  • The outcomes of opioid prescribing strategies in different patient populations, such as children and the elderly

  • The impact of the clinical setting on opioid prescribing strategies (for example, emergency departments, primary care clinics, or ambulatory surgical facilities)

  • How the amount of opioids prescribed and the amount left over affect health outcomes, particularly long-term health outcomes.

Healthcare providers play a "critical role" in addressing the opioid crisis, Woodcock said, "both in reducing the rate of new addiction by decreasing unnecessary or inappropriate exposure to opioid analgesics, while still providing appropriate pain treatment to patients who have medical needs for these medicines. However, there are still too many prescriptions written for opioid analgesics for durations of use longer than are appropriate for the medical need being addressed."

Going forward, Woodcock said 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 (SUPPORT) Act.

This legislation requires 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 FDA remains committed to addressing this national crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal importation and sale of opioid products," said Woodcock.

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