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FDA to issue pain management guidelines

August 23, 2018

By Jennifer Garvin

Silver Spring, Md. — The Food and Drug Administration announced Aug. 22 that it will develop prescribing guidelines in an effort to give health care providers "the most current and comprehensive guidance on the appropriate management of pain."

To do this, the FDA said it has awarded a contract to the National Academies of Sciences, Engineering, and Medicine to develop evidence-based guidelines for "appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures."

"The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner," said FDA Commissioner Scott Gottlieb, M.D., in prepared remarks.

Dr. Gottlieb said the FDA plans to re-examine how opioids are being prescribed since "many common, acute indications" could be treated with "just a day or two of medication rather than a 30-day supply, which is typically prescribed." He also said the FDA is concerned about excess pills being "misused or abused by friends or family members" and the increased risks for misuse, abuse and addiction some patients may face. Strategies for the management of acute pain in medicine and dentistry are the same.

"This presents a difficult challenge both for the U.S. Food and Drug Administration and for health care providers," Dr. Gottlieb said. "We want to reduce the likelihood of misuse and abuse of these drugs and, at the same time, ensure our approaches are properly targeted, evidence-based and serving the medical needs of patients."

"One of the ways we believe we can work together with medical professional societies as good stewards of public health is by developing a framework that can assist them in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed," Dr. Gottlieb concluded. "Ultimately, our public health goal is to support more rational prescribing practices."

The contract with the National Academies of Sciences, Engineering, and Medicine is independent from the National Academy of Medicine's new Action Collaborative on Countering the U.S. Opioid Epidemic, a public-private partnership of which the ADA is a supporting organization.

In March the ADA adopted interim policy on opioid prescribing that supports prescription limits and mandatory continuing education for dentists. The policy is believed to be one of the first of its kind from a major health professional organization. During a meeting with the National Institute on Drug Abuse and National Institute of Dental and Craniofacial Research, leadership from the two NIH branches praised the ADA for the policy.

ADA President Joseph P. Crowley and Executive Director Kathleen T. O'Loughlin met with Commissioner Gottlieb in March. The two shared several opioid articles published in the April 2018 edition of the Journal of the American Dental Association, including a systematic review that found various non-steroidal anti-inflammatory drugs, alone or in combination with acetaminophen, were found to be as effective, if not more effective at managing acute dental pain and produced less side effects than opioids.

For more than 10 years, ADA education efforts on this issue have included free quarterly webinars. The 2018 offerings included information on providers' role in helping DEA prevent prescription drug abuse, interprofessional approaches to addressing opioid abuse, and managing dental pain in adolescents and adults.

Follow all of the opioid-related ADA efforts at ADA.org/opioids.