On August 8, the U.S. Food and Drug Administration (FDA) announced it will conduct a workshop to review the education that opioid prescribers receive. The two-day workshop is scheduled for October 13 and 14 and will take input from all “stakeholders” in the conversation including doctors, researchers, advocates and manufacturers.
In the FDA’s statement, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, stated, “There is no consistent education that all prescribers are required to take about the safe use of opioid medicines.” This has resulted in states coming up with their own standards that “likely differ with regard to content, focus and duration,” according to Dr. Cavazzoni.
The FDA intends to explore whether the agency should release a single standard for educating prescribers on “the appropriate use of opioids, the risks of opioid abuse and misuse and the treatment of opioid use disorder,” in order to address the many needs of prescribers while reducing the burden on them to do their own research.
The public workshop, “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis,” is an example of the variety of interventions the FDA is employing to reduce inappropriate or unnecessary prescribing of opioids.
The FDA announcement noted that the number of dispensed prescriptions for opioids has been steadily decreasing from an all-time peak of 84 prescriptions per 100 residents in 2012 down to 43 prescriptions per 100 residents in 2020.
Even though the number of prescriptions has been cut almost in half, opioid overdoses and opioid-involved deaths are higher than ever. Opioid overdoses have often been seen in combination with other substances such as cocaine, methamphetamine and benzodiazepines.
According to the FDA, opioid overdoses are mostly caused by heroin, fentanyl and fentanyl analogues. Despite the fact that these opioids are illegal and outside the FDA’s regulatory scope, the agency notes that most of these drugs are transitioned to after the user begins to use legally-prescribed opioids recreationally.
With this new education workshop, the FDA may be able to reduce the recreational use of prescribed opioids by standardizing the way states are educating prescribers on the dangers of abuse and addiction.