Opioid Prescribers May Face Strict New Guidelines

By Paul Gaita 07/14/17

The FDA is considering a host of new guidelines to step up efforts to combat opioid overdose rates.

male doctor with stethoscope in medical scrubs holding a bottle and tablets of generic white RX tablets

The Food and Drug Administration (FDA) met on July 10 and 11 to review the efficacy of anti-abuse formulated painkillers in reducing opioid addiction, but agency commissioner Dr. Scott Gottlieb also took the opportunity to address the possibility of holding both immediate-release opioid manufacturers and medical professionals to new and stricter guidelines regarding educational materials on such products.

At the opening of the meeting on July 10, Gottlieb said that he was "actively exploring the question of whether, in the future, there should be mandatory provider education" on prescription opioids—which would require manufacturers to provide doctors, pharmacists and other health professionals with prescriber guidelines for their products. His comments drew opposition from physician groups, which are opposed to a "one-size-fits-all" approach to training.

The Centers for Disease Control and Prevention (CDC) issued guidelines for prescribing opioids to medical professionals in 2016, which recommended prescribing fewer and lower doses of opioids, and to explore the possibility of non-opioid painkillers whenever possible. In spite of these efforts, opioids continued to be a viable option for serious pain relief, which helped to keep dependency and overdose rates at epidemic levels.

"America is simply awash in immediate-release opioid products," said Gottlieb. "Many people who become addicted to opioids will eventually move on to seek higher-dose formulations of these drugs or illicit street drugs, which are increasingly the low-cost alternatives."

To step up efforts to combat opioid overdose rates, Gottlieb proposed that the FDA expand its requirements for prescriber training to include manufacturers of immediate-release opioids. Previously, only manufacturers of extended-release, or long-acting painkillers were required to provide such education. Gottlieb also stated that the agency will release its own recommendations for assessing and managing patients with both opioid-based and non-opioid pain treatment. 

"I've asked my FDA colleagues to take a fresh look at what more we can do to confront this challenge and change the trajectory of the epidemic of addiction afflicting our nation," he said. "We need to make sure we strike a careful balance between access and safety while taking more vigorous steps to combat the epidemic. Given what we already know about the scope of current prescribing and the subsequent patterns of abuse, it's clear that there should be fewer prescriptions being written for opioids."

The American Academy of Family Physicians responded to Gottlieb's comments in a letter issued on July 10 that voiced opposition to limiting patient access to physician-prescribed pharmaceuticals, "as well as any actions that limit physicians' ability to prescribe these products based on the physician's medical specialty."

Writing on behalf of the Academy and its 129,000 family physicians and medical students, Board Chair Wanda D. Filer, M.D. noted that while educating physicians is an important tool, "the education must be designed to address needs and gaps of the learners. 'One size fits all' education is not optimal." Filer recommended that education should be based around "team-based care" involving "shared decision making and patient-centric counseling" that would "[promote] patients as stakeholders in their own care."

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.