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Zdrowie i gospodarka · 09/09/2021

Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis." Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is 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. We expect interested stakeholders to include healthcare providers, healthcare professional associations, pharmacists, pharmacy benefit managers, public and private insurers, patient organizations, Federal and State Agencies, providers of continuing education for healthcare professionals, and the public. 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

Source: Federal Register — Food and Drug AdministrationOpen original release →