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

Abstract

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. The model is aimed at safeguarding patient safety, specifically at avoiding use of FBT and OTFC in opioid non-tolerant patients and at mitigating the risk of abuse, misuse, and diversion, while maintaining access for appropriate patients. The model enrolls wholesalers/distributors, prescribers, pharmacies, and patients into a single system. To enroll, prescribers and pharmacists first complete a mandatory educational module. Enrolled prescribers select and counsel appropriate patients before writing a prescription for FBT or OTFC. At the pharmacy level, controls built in to the system verify enrollment of the prescriber before a prescription for FBT or OTFC is dispensed. In addition, patients are counseled by the pharmacist on the risks and appropriate use of FBT or OTFC. In summary, the REMS model has been designed in partnership with the FDA to ensure wholesalers/distributors, prescribers, pharmacists, and patients are aware of and understand the risks and appropriate use of FBT and OTFC. The effectiveness of the model will be assessed according to an agreed schedule. (Sponsored by Cephalon, Inc.)