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

Author

Listed:
  • 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
    Dartmouth Institute for Health Policy and Clinical Practice)

  • 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
    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)

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.

Suggested Citation

  • 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 Pa, 2021. "A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs," Drug Safety, Springer, vol. 44(7), pages 743-751, July.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:7:d:10.1007_s40264-021-01070-2
    DOI: 10.1007/s40264-021-01070-2
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    References listed on IDEAS

    as
    1. Ameet Sarpatwari & Mengdong He & Frazer A. Tessema & Joshua J. Gagne & Aaron S. Kesselheim, 2021. "Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program," Drug Safety, Springer, vol. 44(3), pages 327-335, March.
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    Cited by:

    1. Mufaddal Mahesri & Ameet Sarpatwari & Krista F. Huybrechts & Joyce Lii & Su Been Lee & Gita A. Toyserkani & Cynthia LaCivita & Esther H. Zhou & Gerald J. Dal Pan & Aaron S. Kesselheim & Katsiaryna Byk, 2024. "Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020," Drug Safety, Springer, vol. 47(9), pages 909-919, September.

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