The U.S. Food and Drug Administration (FDA) will hold in October a two-day virtual public workshop to discuss mandatory prescriber education for opioids, reconsidering its provision through the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS). Stakeholders will provide input on the current opioid crisis that might be measurably ameliorated by making prescriber education mandatory in a REMS. Topics will include how such education could enhance opioid prescribing, pain management and treatment of opioid use disorder; core competencies, knowledge gaps, clinical challenges or misunderstandings among practitioners that this framework could address; and any potential unintended consequences of the educational requirement. Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, described the workshop as "the beginning of an important series of discussions ... 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." She commented that while many public and private organizations have independently implemented their own education programs for safe and effective OA prescribing practices, consistent education on the safe use of opioid medicines is lacking. A second public workshop is expected to compile perspectives on additional issues concerning a transition to mandatory prescriber education under a REMS. Such issues include operational and technical factors and what would be incorporated into mandatory prescriber education.
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