Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations
Agency has been hesitant to take the steps because of logistical difficulties of creating an enormous program, but has been pushed by its risk management advisory committee, among others.
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US FDA is moving forward on two fronts to update and improve the Risk Evaluation & Mitigation Strategy to help limit misuse and abuse of opioid pain medications: the agency has a plan to incorporate IR sponsors into the existing REMS, and also a new 'blueprint' for the prescriber education that focuses on pain management.
US agency is convening two-day workshop on federal efforts to support healthcare provider education about pain management and safe use of the drugs; two University of Washington researchers say agency needs to exercise stricter oversight of opioid marketing and promotion.
This time, the agency may be ready to agree with its advisory committee.