US Opioid Policies Need Major Overhaul, NASEM Says – Medscape

 In Health
A National Academy of Sciences, Engineering, and Medicine (NASEM) panel is calling on regulators to overhaul opioid policies and give more weight to societal risks and benefits when approving or recalling opioid drugs, noting that some of these policies meant to curb the opioid epidemic may actually be driving illicit drug use.

The NASEM panel is also recommending mandatory education on opioid use disorders and pain treatment for prescribers, pharmacists, and others in healthcare, along with removing barriers to evidence-based treatment for opioid use disorders (OUDs).

The committee urged the US Food and Drug Administration (FDA) to review every opioid on the market using a proposed new risk-benefit framework and to promptly remove those that do not meet appropriateness criteria.

The recommendations in the NASEM report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use,”  echo those announced by the FDA in February 2016 as part of an overhaul of how it regulates opioids.

In a statement, FDA Commissioner Scott Gottlieb, MD, said he “was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments.”

The 18-member NASEM committee outlined the facts and trends of what it sees as a deepening opioid crisis — but also said data are severely lacking on the characterization of the epidemic and on the intertwining of pain and OUD.

A Leading Cause of Death

Overdoses are the leading cause of unintentional death in the United States, noted committee chair, Richard J. Bonnie, Harrison Foundation Professor of Medicine and Law and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia, Charlottesville, in a briefing.

“The numbers are extraordinary, and unfortunately, it’s still getting worse,” said Dr Bonnie. He said the response to the epidemic will require a coordinated and sustained effort — with an emphasis on continued attention.

“We have a habit in our country of taking notice and then moving on rapidly to something else,” he said. But, he said, “It took two decades for this epidemic to reach its current proportions, and it will take some significant period of time for it to unwind.”

Efforts to get physicians to write fewer opioid prescriptions have worked, but more needs to be done to educate and train clinicians, pharmacists, and other health professionals about the biology of pain, pain management, and OUD treatment, the panel notes.

That education has largely been provided — after medical school and residency — through continuing medical education sponsored by the opioid manufacturers.

The FDA now requires opioid makers to offer CME to clinicians, pharmacists, and others involved with the therapies. Participation by health professionals is voluntary, but the agency is weighing making participation mandatory.

The NASEM panel said health professional education about pain basics and opioids should be voluntary — and that it should not be offered by drug makers. “It would be optimal if any additional educational programs that we envision would be independent from manufacturers,” said NASEM committee member Aaron Kesselheim, MD, associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics and Law at Brigham & Women’s Hospital, Boston, Massachusetts.

Treatment education, however, should be required, and provided by health professional schools, professional societies, and state licensing boards. That training should include but not be limited to physicians, nurses, pharmacists, dentists, physician assistants, psychologists, and social workers.

Physicians and pharmacists also should be educated and trained to recognize and counsel patients at risk for OUD and/or overdose. The NASEM panel said those providers also should be encouraged to offer the overdose reversal agent naloxone when an opioid is prescribed to those at risk or when a patient seeks treatment for overdose or other opioid-related issues.

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