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US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS
Elaine H Morrato1,2, Elizabeth J Campagna3, Cynthia LaCivita4
1Parkinson School of Health Sciences and Public Health, Loyola University Chicago, 2160 South First Avenue, Building 120, Maywood, IL, 60153, USA. EMorrato@luc.edu.
Risk Evaluation and Mitigation Strategies (REMS) commonly undergo modifications, showing adaptation to new drug evidence and healthcare changes. These updates ensure patient safety and optimize risk management throughout a drug's lifecycle.
Area of Science:
- Pharmacovigilance and Drug Safety
- Health Policy and Regulation
- Pharmaceutical Sciences
Background:
- Risk Evaluation and Mitigation Strategies (REMS) are FDA-mandated interventions for drugs with significant safety concerns.
- REMS aim to ensure benefits outweigh risks and are designed to evolve with new evidence and healthcare contexts.
Purpose of the Study:
- To analyze the frequency and types of REMS modifications over time.
- To provide insights for health policy and pharmacovigilance practices regarding REMS evolution.
Main Methods:
- Retrospective longitudinal case series using FDA's REMS@FDA data (2008-2022).
- Analyzed 100 REMS programs with Elements to Assure Safe Use (ETASU), grouped into 67 REMS Classes.
- Categorized modifications as major or minor based on FDA guidance.
Main Results:
- 96% of REMS classes were modified; modifications occurred frequently (1.2/year/class) and often early (median 15.4 months).
- Most common modifications involved REMS goals/design (221) and materials (167).
- Over time, 50% of early REMS classes evolved to shared systems, and 33% were released from REMS.
Conclusions:
- REMS modifications are common, indicating adaptability to new drug safety data.
- These changes reflect a dynamic learning health system, adjusting to evolving evidence and healthcare delivery.
- Findings support ongoing evaluation and refinement of REMS programs.
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