The Food and Drug Administration (FDA) will be holding a 2-day virtual public workshop to reconsider the need for mandatory opioid prescriber education as part of the Risk Evaluation and Mitigation Strategy (REMS).
In 2012, the FDA had approved the Extended Release/Long Acting (ER/LA) REMS in order to reduce serious adverse outcomes associated with the inappropriate use of extended release and long acting opioid analgesics. At the time, the Agency had decided against making mandatory education a REMS requirement. Instead, the FDA required opioid manufacturers make the training available to prescribers in a variety of formats and as continuing medical education.
Further evaluation of the opioid crisis led to an expansion of the REMS in 2018 to include immediate release opioid analgesics. The revised Opioid Analgesic REMS required that all opioid analgesic manufacturers make training available to prescribers as well as other members of the healthcare team (eg, nurses, pharmacists). The training, however, remained voluntary.
Since 2012, the number of dispensed opioid prescriptions has steadily decreased from 84 prescriptions per 100 residents to 43 prescriptions per 100 residents in 2020. However, overall opioid overdoses and opioid-involved deaths continue to increase, driven mainly by a rise in illicitly manufactured fentanyl and fentanyl analogues.
The public workshop “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis”, will allow participants the opportunity to provide input on a variety of interventions, including prescriber education initiatives, which may help mitigate the current opioid crisis. The workshop is being held on October 13th and 14th, 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. Workshop discussions will focus on how mandatory prescriber education through REMS can improve appropriate opioid prescribing, pain management, and treatment of opioid use disorder.
A second public workshop is being planned to gather input on potential issues associated with a mandatory prescriber education under a REMS, including operational and technical issues related to such a system and what should be included in potential mandatory prescriber education.
- FDA in brief: FDA announces public workshop to reconsider mandatory prescriber education for opioids. News release. US Food and Drug Administration. September 8, 2021. Accessed September 14, 2021. https://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-public-workshop-reconsider-mandatory-prescriber-education-opioids.
- Reconsidering mandatory opioid prescriber education through a risk evaluation and mitigation strategy in an evolving opioid crisis; public workshop; request for comments. News release. US Food and Drug Administration. US Department of Health and Human Services. September 9, 2021. Accessed September 14, 2021. https://www.federalregister.gov/documents/2021/09/09/2021-19437/reconsidering-mandatory-opioid-prescriber-education-through-a-risk-evaluation-and-mitigation.