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A Risk Evaluation and Mitigation Strategy (REMS) to manage the risks of overdose, abuse, addiction, and diversion with rapid-onset opioids

R. Kaper, J. Schmider, R. Bradway, E. Floyd

The Journal of Pain, Volume 11, Issue 4, Supplement, April 2010, pS23

A Risk Evaluation and Mitigation Strategy (REMS), formalized in the Food and Drug Administration Amendments Act (FDAAA) in 2007, is a regulatory strategy to manage a known or potential serious risk. This presentation describes a REMS model developed for the rapid-onset opioids fentanyl buccal tablet (FBT) and oral transmucosal fentanyl citrate (OTFC). In response to requirements delineated by FDA, the model includes elements to assure safe use, a medication guide, an implementation system, and a timetable for assessment.

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