IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v43y2020i5d10.1007_s40264-020-00905-8.html
   My bibliography  Save this article

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
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-020-00905-8
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.

    File URL: https://libkey.io/10.1007/s40264-020-00905-8?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    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. 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.
    3. 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.
    4. 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.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Sigal Kaplan & Aurore Bergamasco & Martin Sergerie & Anne-Marie Castilloux & Yola Moride, 2020. "Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance," Drug Safety, Springer, vol. 43(2), pages 163-177, February.
    2. Camille Goyer & Genaro Castillon & Yola Moride, 2022. "Implementation of Interventions and Policies on Opioids and Awareness of Opioid-Related Harms in Canada: A Multistage Mixed Methods Descriptive Study," IJERPH, MDPI, vol. 19(9), pages 1-12, April.
    3. Soraya Machado de Jesus & Rafael Santos Santana & Silvana Nair Leite, 2020. "The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review," PLOS Neglected Tropical Diseases, Public Library of Science, vol. 14(8), pages 1-24, August.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:43:y:2020:i:5:d:10.1007_s40264-020-00905-8. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.