Implementation of Risk Evaluation and Mitigation Strategy Programs in a Health System


The Food and Drug Administration (FDA) received authority to require manufacturers to develop Risk Evaluation and Mitigation Strategy (REMS) programs from the Food and Drug Administration Amendments Act (FDAAA) of 2007.

Since FDAAA 2007, the number of REMS programs that require elements to assure safe use (ETASU) has increased. The pharmacy leadership team of a ten hospital health system identified the need for a pharmacist to be responsible for the implementation and standardization of REMS programs for the health system. 

In this webinar, Mandy Leonard, PharmD, BCPS and Katie Stabi, PharmD, BCPS: 

  • Define Risk Evaluation and Mitigation Strategy (REMS)
  • Describe the role of a Drug Information Center and a REMS Pharmacist in a health system
  • Define a process that can be created to ensure REMS Program requirements for a medication are addressed
  • Describe ways to utilize technology to meet REMS requirements
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