IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0327363.html
   My bibliography  Save this article

A comparative analysis of three pharmacovigilance system assessment tools

Author

Listed:
  • Muhammad Akhtar Abbas Khan
  • Jude Nwokike
  • Asim Rauf
  • Zaheer-Ud-Din Babar

Abstract

Background: Three key tools are currently available for assessing pharmacovigilance systems at the national level: the Indicator-Based Pharmacovigilance Assessment Tool (IPAT), the World Health Organization (WHO) Pharmacovigilance Indicators, and the Vigilance Module of the WHO Global Benchmarking Tool (GBT). These instruments are designed to evaluate the functionality and performance of national regulatory authorities within the context of their respective pharmacovigilance systems. Objectives: This study aims to identify, analyze, and compare the core characteristics and operational features of these pharmacovigilance assessment tools to better understand their scope, application, and limitations. Methodology: A structured document analysis was conducted on the three identified tools. The content was systematically reviewed, categorized, and synthesized to facilitate a comparative evaluation of its design, focus areas, and assessment criteria. Results: The analysis revealed that the available tools encompass a broad spectrum of indicators targeting different dimensions of pharmacovigilance systems, such as infrastructure, processes, and outcomes. However, exclusive reliance on a single tool may offer a limited perspective, potentially overlooking critical components of a national pharmacovigilance framework. Conclusion: This study underscores the heterogeneity of existing pharmacovigilance assessment tools and emphasizes the importance of context-specific adaptation. A tailored approach, involving the strategic selection or integration of tools, is recommended to ensure a comprehensive and accurate evaluation of national pharmacovigilance systems.

Suggested Citation

  • Muhammad Akhtar Abbas Khan & Jude Nwokike & Asim Rauf & Zaheer-Ud-Din Babar, 2025. "A comparative analysis of three pharmacovigilance system assessment tools," PLOS ONE, Public Library of Science, vol. 20(7), pages 1-12, July.
    • Handle: RePEc:plo:pone00:0327363
    DOI: 10.1371/journal.pone.0327363
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0327363
    Download Restriction: no
    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0327363&type=printable
    Download Restriction: no
    File URL: https://libkey.io/10.1371/journal.pone.0327363?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
    ---><---

    References listed on IDEAS

    as
    1. Aniello Santoro & Georgy Genov & Almath Spooner & June Raine & Peter Arlett, 2017. "Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works," Drug Safety, Springer, vol. 40(10), pages 855-869, October.
    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. Katherine Chinchilla & Cristiano Matos & Victoria Hall & Florence Hunsel, 2021. "Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation," Drug Safety, Springer, vol. 44(2), pages 181-191, February.
    2. Anna Radecka & Louise Loughlin & Mick Foy & Margarida Viana de Ferraz Guimaraes & Viola Macolic Sarinic & Marina Dimov Giusti & Marina Lesicar & Sabine Straus & Dolores Montero & Julia Pallos & Jelena, 2018. "Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action," Drug Safety, Springer, vol. 41(12), pages 1285-1302, December.

    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:plo:pone00:0327363. 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: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    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.