The State of the Opioid Risk Evaluation and Mitigation Strategy Program

Lynn R. Webster, MD

Lifetree Clinical Research and Pain Clinic
Salt Lake City, UT

Prescription opioid misuse and abuse is an exponentially growing problem in the United States. Thus, appropriate patient selection is critical to ensure patient safety and minimize adverse outcomes associated with prescription opioid use. As first outlined by the Food and Drug Administration (FDA) Amendments Act of 2007, the FDA has developed Risk Evaluation and Mitigation Strategy (REMS) programs to minimize risks associated with certain prescription drugs. This approach requires drug manufacturers to implement measures to evaluate and mitigate safety issues for their products and ensure that the benefits of the drugs continue to outweigh their risks. Recently, the FDA has considered implementing a class-wide REMS for extended-release opioids and is currently reviewing input from the public and stakeholders.

References

Lipman AG. The Food and Drug Administration opioid Risk Evaluation and Mitigation Strategy. J Pain Palliat Care Pharmacother. 2009;23(3):219-221.
Hertz JA, Knight JR. Prescription drug misuse: a growing national problem. Adolesc Med Clin. 2006;17:751-769.
Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84:593-601.

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