Issues and critiques of the forthcoming risk evaluation and mitigation strategy (REMS) for opioids in pain management.

OBJECTIVE: To examine the history and suitability of the Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategy (REMS) for reducing the safety risks associated with the use of opioid medications, including the risks of abuse and overdose. This article will highlight recent attempts by the FDA to introduce a class wide REMS for new and existing Schedule II long-acting opioid drugs. A critique of these current REMS efforts and recommendations for the future will also be provided.

DESIGN: A literature review and commentary design are utilized to highlight issues surrounding REMS efforts and to explore possible future directions. Expert opinion is offered to potentially guide future efforts in this arena.

CONCLUSIONS: The stated goal of the FDA's proposed class wide opioid REMS program is to decrease abuse, misuse, addiction and overdose deaths from opioid medications. While the REMS program may have theoretical capabilities for evaluating and addressing problematic drug use among prescribed patients, it is unlikely to reduce the bulk of prescription drug abuse that occurs with non-patients. Our recommendations provide some ideas on how the REMS program can be improved to achieve the goals set for it by Congress and the FDA.