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Risk Evaluation and Mitigation Strategies, REMS

  • Definitions
  1. Risk Evaluation and Mitigation Strategies (REMS)
    1. FDA programs for high risk medications
    2. Requires mandatory provider certification, patient counseling by pharmacist, Patient Education
  • Preparations
  • Examples
  1. Isotretinoin (Accutane)
  2. Clozapine
  3. Thalidomide
  • Resources
  1. FDA: Risk Evaluation and Mitigation Strategies (REMS)
    1. https://www.fda.gov/Drugs/DrugSafety/REMS/default.htm