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Incorporating REMS Programs into the Pharmacy Process:

Risk Evaluation and Mitigation Strategy (REMS) programs can be required by the Food and Drug Administration (FDA) for medications with serious safety concerns or adverse effects. Pharmacists and pharmacy technicians need to be familiar with the mandatory components of a medication’s REMS program. Examples of mandatory REMS tasks for pharmacists and pharmacy technicians will be reviewed. Additionally, recently approved medications with REMS in 2021, as well as modified REMS programs, such as pending changes for dispensing clozapine, will be examined.

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