The U.S. Food and Drug Administration (FDA) is reconsidering the need for mandatory opioid prescriber education through the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS), according to an announcement by Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The agency announced a two-day public workshop “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS.
Among the diverse topics that will be discussed, the FDA will explore the value of a single source for education on the appropriate use of opioids, risks of opioid abuse and misuse and treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.
The number of dispensed prescriptions for opioid analgesics has been steadily declining from a peak of 84 prescriptions per 100 residents in 2012 to 43 prescriptions per 100 residents in 2020.
A wide variety of interventions intended to reduce inappropriate or unnecessary prescribing, including prescriber education initiatives.
Despite this decrease in dispensing, opioid overdoses and opioid-involved deaths are higher than ever, with opioids often seen in combination with other substances such as cocaine, methamphetamine and benzodiazepines.
This rise has been driven primarily by a surge in overdose deaths initially involving heroin and then illicitly manufactured fentanyl and fentanyl analogues. Although these overdose deaths largely involve illicit substances, many users of illicit opioids are initially exposed to them through nonmedical use of prescription opioids. Moreover, as of 2020, prescription opioids were involved in more than 16,000 fatal overdoses per year, higher than the number seen at the peak of opioid analgesic dispensing in 2012.
The workshop is being convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between the FDA and Duke-Margolis. A second public workshop is being planned to solicit input on additional issues associated with a move to mandatory prescriber education under a REMS, such as operational and technical issues related to such a system and what should be included in potential mandatory prescriber education.