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Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators

Author

Listed:
  • Hamza Garashi

    (Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology Medicine and Health, The University of Manchester, Manchester M13 9PT, UK)

  • Douglas Steinke

    (Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology Medicine and Health, The University of Manchester, Manchester M13 9PT, UK)

  • Ellen Schafheutle

    (Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology Medicine and Health, The University of Manchester, Manchester M13 9PT, UK)

Abstract

Using the WHO pharmacovigilance (PV) indicators as a framework, this study aimed to explore the structures, processes, and outcomes of three Arab countries’ (Jordan, Oman, and Kuwait) PV systems to inform recommendations for countries with nascent PV systems. A mixed-methods design involving document review, semi-structured interviews, and a questionnaire was employed. Fifty-six key informants from the three countries’ national PV centres (NPVCs) and pharmaceutical industry were interviewed. The questionnaire collecting quantitative measures was only completed by Oman and Kuwait’s NPVCs. Using the framework, system strengths were attributed to the presence of “core” structural indicators, including a dedicated and officially recognised NPVC, PV legislation, and a national PV advisory committee, as well as “complementary” structural indicators, e.g., a computerised case-report management system. Contrastingly, weaknesses were attributed to the absence of these indicators plus other “core” structural indicators, namely, regular financial provision and adequate staff. Other weaknesses were attributed to low performance in “core” process and outcome indicators including reporting rates, reporter awareness, and signal detection. Greater governmental prioritisation through the provision of legislative enforcements, resources, and expertise as part of a well-structured system is required. More regional coordination efforts are needed to allow for sharing of expertise in order to bolster nascent systems.

Suggested Citation

  • Hamza Garashi & Douglas Steinke & Ellen Schafheutle, 2022. "Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators," IJERPH, MDPI, vol. 19(5), pages 1-19, February.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:5:p:2518-:d:755431
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    References listed on IDEAS

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    1. Cacace, Mirella & Ettelt, Stefanie & Mays, Nicholas & Nolte, Ellen, 2013. "Assessing quality in cross-country comparisons of health systems and policies: Towards a set of generic quality criteria," Health Policy, Elsevier, vol. 112(1), pages 156-162.
    2. Hennink, Monique & Kaiser, Bonnie N., 2022. "Sample sizes for saturation in qualitative research: A systematic review of empirical tests," Social Science & Medicine, Elsevier, vol. 292(C).
    3. Li Zhang & Lisa Wong & Ying He & Ian Wong, 2014. "Pharmacovigilance in China: Current Situation, Successes and Challenges," Drug Safety, Springer, vol. 37(10), pages 765-770, October.
    4. Thamir M. Alshammari & Neslihan Mendi & Khalidah A. Alenzi & Yazed Alsowaida, 2019. "Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries," Drug Safety, Springer, vol. 42(7), pages 849-868, July.
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