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Mitigating the Safety Risks of Drugs With a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer?

Mayo Clinic Proceedings, Volume 89, Issue 12, December 2014, Pages 1673 - 1684


Approximately 40% of all newly approved drugs are subject to safety restrictions inclusive of Risk Evaluation and Mitigation Strategies (REMS), which were created with the US Food and Drug Administration Amendments Act of 2007. This law expanded Food and Drug Administration (FDA) authority to require REMS of manufacturers but left implementation to the FDA. As a result, the potential access to medications that are effective but not without safety concerns has improved, yet the converse is also true because access may be restricted due to REMS requirements (eg, physician or patient registration). With the July 2012 reauthorization of the Prescription Drug User Fee Act, the FDA was given additional authorities and mandates for enhancing and modernizing the drug safety system—specifically, measuring the effectiveness of REMS as well as standardizing and better integrating REMS into the overall health care system. So, are REMS, which were conceived as a tool to improve medication safety, working? Specifically, are REMS achieving their intended outcomes (mitigating safety risks of effective drugs) without causing unintended consequences (creating a burden to the health care system and physicians and/or diminishing patient access to drugs)? Sitting squarely in the crosshairs, the approved shared REMS for extended-release/long-acting opioid analgesics provide a lens through which this question can be examined. This article discusses the current status, stakeholders, and key policy issues for clinicians with a focus on the shared REMS for opioids, as well as the anticipated role of clinicians in optimizing patient care in the new world of REMS.

Abbreviations and Acronyms: ANDA - Abbreviated New Drug Application, ER/LA - extended-release/long-acting, ETASU - Elements to Assure Safe Use, FDA - Food and Drug Administration, FDAAA - FDA Amendments Act, MedGuides - Medication Guides, NDA - New Drug Application, PDUFA V - Prescription Drug User Fee Act, REMS - Risk Evaluation and Mitigation Strategies, RPC - REMS Program Companies, TIRF - transmucosal immediate-release fentanyl.


ProEd Communications, Inc, Beachwood, OH

Correspondence: Address to Marta J. Brooks, PharmD, ProEd Communications, Inc, 25101 Chagrin Blvd, Ste 230, Beachwood, OH 44122.