Risk Evaluation and Mitigation Strategies

Aka: Risk Evaluation and Mitigation Strategies, REMS

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II. 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

III. Preparations: Examples

  1. Isotretinoin (Accutane)
  2. Clozapine
  3. Thalidomide

IV. Resources

  1. FDA: Risk Evaluation and Mitigation Strategies (REMS)
    1. https://www.fda.gov/Drugs/DrugSafety/REMS/default.htm

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