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Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review

Author

Listed:
  • Andrea M. Russell

    (Northwestern University Feinberg School of Medicine)

  • Elaine H. Morrato

    (University of Colorado Anschutz Medical Campus)

  • Rebecca M. Lovett

    (Northwestern University Feinberg School of Medicine)

  • Meredith Y. Smith

    (Global Patient Safety, Labeling and Pediatrics, Amgen, Inc.
    University of Southern California)

Abstract

Introduction Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety. Objective The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs. Methods Peer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included. Results Key opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access. Conclusions Gaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine.

Suggested Citation

  • Andrea M. Russell & Elaine H. Morrato & Rebecca M. Lovett & Meredith Y. Smith, 2020. "Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review," Drug Safety, Springer, vol. 43(5), pages 427-446, May.
    • Handle: RePEc:spr:drugsa:v:43:y:2020:i:5:d:10.1007_s40264-020-00905-8
    DOI: 10.1007/s40264-020-00905-8
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    References listed on IDEAS

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    1. Wally Landsberg & Imad Al-Dakkak & Antonia Coppin-Renz & Uli Geis & Timothy Peters-Strickland & Emiel Heumen & Mirza Rahman, 2018. "Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study," Drug Safety, Springer, vol. 41(8), pages 797-806, August.
    2. Giampiero Mazzaglia & Sabine M. J. Straus & Peter Arlett & Daniela Silva & Heidi Janssen & June Raine & Enrica Alteri, 2018. "Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs," Drug Safety, Springer, vol. 41(2), pages 191-202, February.
    3. Nancy A. Brandenburg & Robert Bwire & John Freeman & Florence Houn & Paul Sheehan & Jerome B. Zeldis, 2017. "Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention," Drug Safety, Springer, vol. 40(4), pages 333-341, April.
    4. Meredith Y. Smith & Andrea Russell & Priya Bahri & Peter G. M. Mol & Sarah Frise & Emily Freeman & Elaine H. Morrato, 2018. "The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products," Drug Safety, Springer, vol. 41(4), pages 389-401, April.
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