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Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®

Author

Listed:
  • Haggar H. Ampadu

    (School of Medicine and Dentistry, University of Ghana
    Utrecht University)

  • Jarno Hoekman

    (Utrecht University)

  • Marieke L. Bruin

    (Utrecht University)

  • Shanthi N. Pal

    (Safety and Vigilance, World Health Organization)

  • Sten Olsson

    (Uppsala Monitoring Centre)

  • Daniele Sartori

    (Uppsala Monitoring Centre)

  • Hubert G. M. Leufkens

    (Utrecht University)

  • Alexander N. O. Dodoo

    (School of Medicine and Dentistry, University of Ghana)

Abstract

Introduction Following the start of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) by 10 member countries in 1968, it took another 24 years for the first two African countries to join in 1992, by which time the number of member countries in the PIDM had grown to 33. Whilst pharmacovigilance (PV), including the submission of individual case safety reports (ICSR) to VigiBase®, the WHO global ICSR database, is growing in Africa, no data have been published on the growth of ICSR reporting from Africa and how the features of ICSRs from Africa compare with the rest of the world (RoW). Objective The objective of this paper was to provide an overview of the growth of national PV centres in Africa, the reporting of ICSRs by African countries, and the features of ICSRs from Africa, and to compare ICSRs from Africa with the RoW. Methods The search and analysis interface of VigiBase®—VigiLyze®—was used to characterise ICSRs submitted by African countries and the RoW. The distribution of ICSRs by African countries was listed and characterised by anatomic therapeutic chemical (ATC) code, Medical Dictionary for Regulatory Activities (MedDRA®) system organ class (SOC) classification, and patient age and sex. The case-defining features of ICSRs between Africa and the RoW were also compared. Results The number of African countries in the PIDM increased from 2 in 1992 to 35 at the end of September 2015, and African PIDM members have cumulatively submitted 103,499 ICSRs (0.88 % of global ICSRs) to VigiBase®. The main class of products in African ICSRs are nucleoside and nucleotide reverse transcriptase inhibitors (14.04 %), non-nucleoside reverse transcriptase inhibitors (9.09 %), antivirals for the treatment of HIV infections (5.50 %), combinations of sulfonamides and trimethoprim (2.98 %) and angiotensin-converting enzyme (ACE) inhibitors (2.42 %). The main product classes implicated in ICSRs from the RoW are tumour necrosis factor-α (TNFα) inhibitors (5.29 %), topical nonsteroidal anti-inflammatory preparations (2.26 %), selective immunosuppressants (2.08 %), selective serotonin reuptake inhibitors (2.04 %) and HMG CoA reductase inhibitors (1.85 %). The main SOCs reported from Africa versus the RoW include skin and subcutaneous tissue disorders (31.14 % vs. 19.58 %), general disorders and administration site conditions (20.91 % vs. 30.49 %) and nervous system disorders (17.48 % vs. 19.13 %). The 18–44 years age group dominated ICSRs from Africa, while the 45–64 years age group dominated the RoW. Identical proportions of females (57 % Africa and the RoW) and males (37 % Africa and the RoW) were represented. Conclusions As at the end of September 2015, 35 of 54 African countries were Full Member countries of the PIDM. Although the number of ICSRs from Africa has increased substantially, ICSRs from Africa still make up

Suggested Citation

  • Haggar H. Ampadu & Jarno Hoekman & Marieke L. Bruin & Shanthi N. Pal & Sten Olsson & Daniele Sartori & Hubert G. M. Leufkens & Alexander N. O. Dodoo, 2016. "Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®," Drug Safety, Springer, vol. 39(4), pages 335-345, April.
  • Handle: RePEc:spr:drugsa:v:39:y:2016:i:4:d:10.1007_s40264-015-0387-4
    DOI: 10.1007/s40264-015-0387-4
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    1. Jürgen Beckmann & Ulrich Hagemann & Priya Bahri & Andrew Bate & Ian Boyd & Gerald Dal Pan & Brian Edwards & I. Edwards & Kenneth Hartigan-Go & Marie Lindquist & John McEwen & Yola Moride & Sten Olsson, 2014. "Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum," Drug Safety, Springer, vol. 37(10), pages 743-759, October.
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    1. Fawzi Thomas & Onome T. Abiri & James P. Komeh & Thomas A. Conteh & Abdulai Jawo Bah & Joseph Sam Kanu & Robert Terry & Arpine Abrahamyan & Pruthu Thekkur & Rony Zachariah, 2022. "Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting," IJERPH, MDPI, vol. 19(6), pages 1-12, March.
    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. Agnieszka Zimmermann & Agata Flis & Aleksandra Gaworska–Krzemińska & Marsha N Cohen, 2020. "Drug-safety reporting in Polish nursing practice—Cross sectional surveys," PLOS ONE, Public Library of Science, vol. 15(10), pages 1-13, October.
    4. Peter Yamoah & Frasia Oosthuizen, 2018. "An Assessment of the Reporting Pattern of Adverse Events Following Immunizations in VigiAccess," Global Journal of Health Science, Canadian Center of Science and Education, vol. 10(11), pages 1-46, November.
    5. George Tsey Sabblah & Delese Mimi Darko & Hudu Mogtari & Linda Härmark & Eugène Puijenbroek, 2017. "Patients’ Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana," Drug Safety, Springer, vol. 40(10), pages 911-921, October.

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