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Evaluation of the extended-release/long-acting opioid prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: a review.

Heyward J, Olson L, Sharfstein JM, et al. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration. JAMA Intern Med. 2019;180(2):301-309. doi:10.1001/jamainternmed.2019.5459.

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January 22, 2020
Heyward J, Olson L, Sharfstein JM, et al. JAMA Intern Med. 2019;180(2):301-309.
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Using documentation obtained through a Freedom of Information Act request, researchers investigated the implementation and effectiveness of the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioids. The REMS require manufacturers to deliver continuing education, develop medication guides for patients about opioid risks, and monitor and report on prescriber knowledge/behavior and patient safety. The authors found that the program was generally implemented as planned, but the effects of the program on inappropriate prescribing or improved patient outcomes could not be assessed because manufacturers collected population-level ecological data and did not collect data on patient-level outcomes. A previous WebM&M commentary describes an adverse event related to long-acting opioids.

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Heyward J, Olson L, Sharfstein JM, et al. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration. JAMA Intern Med. 2019;180(2):301-309. doi:10.1001/jamainternmed.2019.5459.

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