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- Susan C Nicholson, Kimberly Evanyo, Gregory D Salinas, Nancy Roepke, B Stephen Burton, and Debi Susalka.
- Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
- J Opioid Manag. 2012 Jul 1;8(4):212-6.
AbstractThe 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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