FDA Panel Recommends Mandatory Opioid Training

David Smart/SHUTTERSTOCK.COM

According to Committee Chairperson Almut Winterstein, PhD, chair of the Drug Safety and Risk Management Committee and professor and chair of pharmaceutical outcomes and policy at the College of Pharmacy at the University of Florida in Gainesville, “Voluntary training under the current REMS has only been able to reach about 20% of all opioid prescribers. Most committee members felt that the only way to accelerate the process was to make the training mandatory.”

Joanna Katzman, MD, MSPH, director of the University of New Mexico Pain Center and a neurologist with University of New Mexico Health Sciences Center in Albuquerque, was invited to speak to the panel because of her experience with mandatory prescribing regulations. Dr. Katzman said the FDA’s current program doesn’t provide enough education on short-acting opioids or pain management. “These topics are important because, like long-acting opioids, short-acting opioids have risks associated with them,” she said. She added that the FDA’s program hasn’t reduced the number of opioids that have been prescribed or the number of deaths due to drug overdoses.

Dr. Messner believes that otolaryngologists would most benefit from increased knowledge about postoperative pain management strategies. “Historically, otolaryngologists relied almost exclusively on narcotics as the foundation of a pain control plan,” she said. “Now we know that there are alternative medications and pain control strategies that result in better pain control, without the risk of narcotics.”

Some panel members also suggested that clinicians be trained in best practices of pain management, that training be tied to recently released CDC guidelines, and that it involve mental health and suicide screening. “There needs to be education around safe prescribing methods, because, over the past decade, many physicians have become used to writing prescription refills without realizing the consequences of some patients becoming dependent on medications,” Dr. Katzman said. “By giving physicians such as otolaryngologists information regarding alternatives to opioid medications, such as non-opioid medications or other non-pharmacological modalities, such as speech and physical therapy, transcutaneous electrical nerve stimulation (TENS) units, and even behavioral interventions, they will have other options for treating patients who are in pain after having surgical procedures.”

Dr. Katzman also said it is incumbent upon healthcare professionals to learn how to screen patients so that they can prescribe a safe number of painkillers. “Most people who die of an unintentional opioid or heroin overdose get medications from a friend or relative,” she said. “These friends and relatives usually receive their medications from one doctor.”

What Training Might Entail

It’s now up to the FDA to decide what the training will entail and when it will become effective. Dr. Katzman said the FDA could implement a mandatory REMS program or consider other options, such as working with the U.S. Drug Enforcement Administration to enforce it or making continuing medical education a requirement to renew a medical license. The FDA could also suggest that individual states impose the mandate through medical licensing boards.