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Drugs with Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU) & Utilization

Basic Details
Status
Complete
Last Updated
Tuesday, July 23, 2024
Original Posting Date
Health Outcome(s)
utilization
Purpose
Drug Use
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

The U.S. Food and Drug Administration (FDA) pursued this study to demonstrate how Sentinel can be utilized to answer regulatory questions regarding drugs with elements to assure safe use (ETASU) by exploring the utilization patterns of drugs with approved Risk Evaluation and Mitigation Strategies (REMS) that employ ETASU. To ensure that the benefits of a drug or biological product outweigh its risks, the FDA can require a REMS with an ETASU to mitigate a specific and serious risk listed in the labeling of the drug. This study provided summary tables of total counts, incidence, and prevalence of dispensings and procedure codes of drugs with approved REMS that employ ETASU among enrolled members in the Sentinel Distributed Database (SDD). This study provided baseline information on utilization patterns of specific drugs with REMS with ETASU which could support the planning of future studies on these products.

Result(s) (2)
Utilization of Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU) Utilization of Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU): A Descriptive Analysis