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Extended-release/long-acting opioid REMS may fill the need for prescribers' appropriate use education

S.C. Nicholson, K. Evanyo, G.D. Salinas, N. Roepke, B.S. Burton, D. Susalka

Journal of Opioid Management, Volume 8, Issue 4, Jul-Aug 2012, p212

Abstract
The Food and Drug Administration (FDA) is requiring manufacturers of long-acting and extended-release opioids to have a class-wide Risk Evaluation and Mitigation Strategy (REMS). The comprehensive risk management plan will include training for prescribers on the appropriate and safe use of these pain medications. The letter dated April 19, 2011 from FDA to manufacturers outlining the REMS requirements describes voluntary training that should be certified education "where practicable." The current report includes data from a recent comprehensive study of healthcare professionals and patients and highlights key insights that can guide the development of the opioid REMS training

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