- The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
- A component of REMS is the FDA’s “Blueprint for Prescribing Continuing Education Program” whose first draft was published on 10/25/11. The intended audience is physicians who prescribe extended-release and long-acting opioids, and its content expounds upon what the FDA considers to be “best practices.” While the FDA has not announced its timeframe for the comment period, it is obvious that the evolving REMS strategy is a priority. As a side note, Dr. Suzanne Novak opined to workcompcentral (subscription required) on 12/15/11 that this blueprint should be provided as mandated CME courses.
- In 2011 President Obama launched a national drug control strategy that includes a specific “Epidemic: Responding to America’s Prescription Drug Abuse Crisis” The four cornerstones are education, tracking and monitoring, proper medication disposal, and enforcement. One key tactic is to build Prescription Drug Monitoring Program (PDMP) interoperability across state lines (for a good overview visit The Alliance of States with Prescription Monitoring Programs).
- While not new, the U.S. Department of Health and Human Services manages a National Guideline Clearinghouse that consolidates evidence-based clinical practice guidelines.
In this together – Mark
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