The Food and Drug Administration Risk Evaluation and Mitigation Strategies on the Use of Opioids: Focus on Education

Douglas C. Throckmorton, MD

Deputy Director
Center for Drug Evaluation and Research

To address the escalating problem of prescription opioid abuse, the Food and Drug Administration (FDA) has developed the risk evaluation and mitigation strategy (REMS) for the use of long-acting opioids. The FDA chose to focus on these drugs because they are involved in a significant proportion of the problems related to aberrant opioid use. Furthermore, placing restrictions on all classes of opioids may have imposed an unnecessary burden on the healthcare system. Nevertheless, the FDA recognizes the dangers presented by the immediate-release opioids abuse and is now developing a separate REMS for these drugs. The goal of both of the REMS is to prevent abuse and minimize misuse of opioids, while ensuring that the patients who benefit from these medicines continue to have access to them. In addition, the FDA partakes in the Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) program -- a joint effort of the government, academia, and pharmaceutical industry to develop new classes of pain medicines.

In this video, Dr. Douglas Throckmorton, Deputy Director of the Center for Drugs Evaluation and Research, provides commentary regarding the use and abuse of opioids, as well as an update on the steps the FDA is taking to prevent it.

References

Slevin KA, Ashburn MA. Primary care physician opinion survey on FDA opioid risk evaluation and mitigation strategies. J Opioid Manag. 2011 Mar-Apr;7(2):109-15.
Craig DS. The Food and Drug Administration risk evaluation and mitigation strategy. J Pain Palliat Care Pharmacother. 2010 Jun;24(2):145-8.
Rappaport BA, Cerny I, Sanhai WR. ACTION on the Prevention of Chronic Pain after Surgery: Public-Private Partnerships, the Future of Analgesic Drug Development. Anesthesiology. 2010 Mar; 112(3): 509-510.

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