FDA Public Workshop on Opioid Prescriber Education

Margolis-FDA Convening: Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Crisis

Workshop Times and Dates

Wednesday, October 13: 1:00pm - 5:00pm EDT

Thursday, October 14: 1:00pm - 4:05pm EDT 

Event Summary

The estimated number of opioid analgesic prescriptions dispensed per capita in the United States has been steadily declining from a peak of 81 prescriptions per 100 residents in 2012 to 47 prescriptions per 100 residents in 2020 due to a wide variety of interventions, including prescriber education initiatives, intended to reduce inappropriate or unnecessary prescribing. Despite this decline, 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 opioids 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.

As the opioid and substance use crisis continues to evolve, The U.S. Food and Drug Administration (FDA) is reconsidering whether to require prescribers to complete education as part of the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS) and seeks input about the aspects of the opioid crisis that mandatory prescriber training through such a REMS could potentially mitigate. In light of the many available education programs and the lack of a nationwide standard, FDA is exploring the value of using the OA REMS to provide education on the appropriate use of opioids, on the risks of opioid abuse and misuse, and on the treatment of opioid use disorder. The dynamics of the opioid and substance use crisis have shifted significantly since the Opioid Analgesic REMS was initially implemented and new opportunities may have emerged for improving prescriber education at the Federal level and beyond. 

Please join the Duke-Margolis Center for Health Policy and the FDA for a two-day virtual public workshop that will convene regulators, clinical researchers, providers, patient advocates, and other stakeholders to exchange information and obtain input by discussing prescriber education’s potential role in alleviating the evolving opioid and substance use crisis. Participants will discuss the current landscape of the crisis, the state of opioid prescriber education, recent trends in opioid prescribing and pain management, the current state of opioid prescriber education requirements and opportunities to improve them, the potential role of prescriber education in alleviating the crisis, considerations for the future role of mandatory prescriber education through a REMS, and next steps for opioid prescriber education.

To register for the event, click here. Please email Thomas Roades or Brian Canter with any questions.