A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Ameet Sarpatwari (), Mayookha Mitra-Majumdar, Katsiaryna Bykov, Jerry Avorn, Steven Woloshin, Gita A. Toyserkani, Cynthia LaCivita, Claudia Manzo, Esther H. Zhou, Ellen Pinnow, Gerald J. Dal Pan, Joshua J. Gagne, Krista F. Huybrechts, William B. Feldman, Kristyn Chin and Aaron S. Kesselheim
Additional contact information
Ameet Sarpatwari: Brigham and Women’s Hospital and Harvard Medical School
Mayookha Mitra-Majumdar: Brigham and Women’s Hospital and Harvard Medical School
Katsiaryna Bykov: Brigham and Women’s Hospital and Harvard Medical School
Jerry Avorn: Brigham and Women’s Hospital and Harvard Medical School
Steven Woloshin: Brigham and Women’s Hospital and Harvard Medical School
Gita A. Toyserkani: Center for Drug Evaluation and Research, Food and Drug Administration
Cynthia LaCivita: Center for Drug Evaluation and Research, Food and Drug Administration
Claudia Manzo: Center for Drug Evaluation and Research, Food and Drug Administration
Esther H. Zhou: Center for Drug Evaluation and Research, Food and Drug Administration
Ellen Pinnow: Center for Drug Evaluation and Research, Food and Drug Administration
Gerald J. Dal Pan: Center for Drug Evaluation and Research, Food and Drug Administration
Joshua J. Gagne: Brigham and Women’s Hospital and Harvard Medical School
Krista F. Huybrechts: Brigham and Women’s Hospital and Harvard Medical School
William B. Feldman: Brigham and Women’s Hospital and Harvard Medical School
Kristyn Chin: Brigham and Women’s Hospital and Harvard Medical School
Aaron S. Kesselheim: Brigham and Women’s Hospital and Harvard Medical School

Drug Safety, 2021, vol. 44, issue 7, No 3, 743-751

Abstract: Abstract Introduction Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Such programs can include requirements for patient monitoring, restrictions on dispensing or administration, and physician and pharmacy training and certification. However, there has been only scattered evidence on the impact of REMS programs on informed decision making, medication access, or patient outcomes. Objective The objective of this article was to describe a study that researchers at Brigham and Women’s Hospital and Harvard Medical School will conduct in partnership with the Food and Drug Administration’s Office of Surveillance and Epidemiology to investigate systematically how REMS programs have operated in practice. Methods Investigations include health insurance claims-based analyses to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs; surveys and interviews to understand physician and patient experiences with REMS; and REMS program material-based and interview-based analyses to understand the effectiveness of risk communication in REMS programs. Conclusions These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.

Date: 2021
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DOI: 10.1007/s40264-021-01070-2

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