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Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries

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  • Wiwan Worakunphanich

    (Doctor of Philosophy Program in Social, Economic, and Administrative Pharmacy, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand
    Thai Traditional Medicine Research Institute, Department of Thai Traditional and Alternative Medicine, Ministry of Public Health, Nonthaburi 11000, Thailand)

  • Sitaporn Youngkong

    (Health Technology Assessment Graduate Program, Mahidol University, Bangkok 10400, Thailand
    Social and Administrative Pharmacy Excellence Research (SAPER) Unit, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand)

  • Wimon Suwankesawong

    (The College of Pharmaceutical and Health Consumer Protection of Thailand, Bangkok 10330, Thailand)

  • Claire Anderson

    (School of Pharmacy, University of Nottingham, Nottingham NG7 2RD, UK)

  • Montarat Thavorncharoensap

    (Health Technology Assessment Graduate Program, Mahidol University, Bangkok 10400, Thailand
    Social and Administrative Pharmacy Excellence Research (SAPER) Unit, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand)

Abstract

Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country’s system should be adopted.

Suggested Citation

  • Wiwan Worakunphanich & Sitaporn Youngkong & Wimon Suwankesawong & Claire Anderson & Montarat Thavorncharoensap, 2022. "Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries," IJERPH, MDPI, vol. 19(8), pages 1-12, April.
  • Handle: RePEc:gam:jijerp:v:19:y:2022:i:8:p:4447-:d:788891
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    References listed on IDEAS

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    1. Marin Banovac & Gianmario Candore & Jim Slattery & Francois Houÿez & David Haerry & Georgy Genov & Peter Arlett, 2017. "Patient Reporting in the EU: Analysis of EudraVigilance Data," Drug Safety, Springer, vol. 40(7), pages 629-645, July.
    2. Inácio, Pedro & Gomes, João José & Airaksinen, Marja & Cavaco, Afonso, 2018. "Exploring sociodemographic and economic factors that promote adverse drug reactions reporting by patients," Health Policy, Elsevier, vol. 122(3), pages 263-268.
    3. Sieta T. de Vries & Petra Denig & Carmen Lasheras Ruiz & François Houÿez & Lisa Wong & Alastair Sutcliffe & Peter G. M. Mol, 2018. "Interest in a Mobile App for Two-Way Risk Communication: A Survey Study Among European Healthcare Professionals and Patients," Drug Safety, Springer, vol. 41(7), pages 697-712, July.
    Full references (including those not matched with items on IDEAS)

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