The FDA is holding a workshop to discuss mandatory opioid prescriber education through the Opioid Analgesic Risk Evaluation and Mitigation Strategy.
The US Food and Drug Administration (FDA), in partnership with the Duke-Margolis Center for Health Policy, plans to hold a virtual public workshop that will allow participants to provide input on the current opioid crisis and how it might be mitigated by requiring prescribers of opioids to complete education as part of a Risk Evaluation and Mitigation Strategy (REMS).
The workshop, titled "Reconsidering Mandatory Opioid Prescriber Education Through a REMS in an Evolving Opioid Crisis,” will occur on October 13-14, 2021.
“The FDA recognizes that there may be new opportunities to improve prescriber education through the Opioid Analgesic Risk Evaluation and Mitigation Strategy and ensure that the education is being delivered in a way that minimizes the burden on the healthcare delivery system,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “The upcoming public workshop is the beginning of an important series of discussions with a broad group of stakeholders as the agency explores the value of mandatory opioid prescriber education on the appropriate use of opioids, the risks of opioid abuse and misuse and the treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.”1
Topics to be discussed include the value of a single source for education on the appropriate use of opioids, risks of opioid abuse, and treatment of opioid use disorder. A wide variety of interventions intended to reduce inappropriate or unnecessary prescribing will also be evaluated.
Additionally, a second workshop is being planned to gather input on potential issues associated with a move to mandatory prescriber education under a REMS, like what operational and technical issues might arise with such a system, and what should be included in potential mandatory prescriber education.
“Opioid addiction and abuse remain a serious public health crisis and addressing it is among the FDA’s highest priorities. We will continue to explore new approaches that allow us to confront the crisis head-on,” said Cavazzoni.1
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1. US Food and Drug Administration. FDA in brief: FDA announces public workshop to reconsider mandatory prescriber education for opioids. News release. September 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-public-workshop-reconsider-mandatory-prescriber-education-opioids?utm_medium=email&utm_source=govdelivery