IDEAS home Printed from https://ideas.repec.org/a/gam/jijerp/v19y2022i6p3264-d768149.html
   My bibliography  Save this article

Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting

Author

Listed:
  • Fawzi Thomas

    (National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
    College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone)

  • Onome T. Abiri

    (National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
    College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone)

  • James P. Komeh

    (National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
    College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone)

  • Thomas A. Conteh

    (National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone
    College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone)

  • Abdulai Jawo Bah

    (College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone
    Institute of Global Health and Development, Queen Margaret University, Edinburgh EH21 6UU, UK)

  • Joseph Sam Kanu

    (College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone
    National Disease Surveillance Program, Directorate of Health Security and Emergencies, Ministry of Health and Sanitation, Freetown 02717, Sierra Leone)

  • Robert Terry

    (UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in Tropical Diseases (TDR), 1211 Geneva, Switzerland)

  • Arpine Abrahamyan

    (Tuberculosis Research and Prevention NGO (TB-RPC), Yerevan 0014, Armenia)

  • Pruthu Thekkur

    (Centre for Operational Research, International Union against Tuberculosis and Lung Disease, 75001 Paris, France)

  • Rony Zachariah

    (UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in Tropical Diseases (TDR), 1211 Geneva, Switzerland)

Abstract

Background: Monitoring of adverse drug reactions (ADRs) to antimicrobials is important, as they can cause life-threatening illness, permanent disabilities, and death. We assessed country-wide ADR reporting on antimicrobials and their outcomes. Methods: A cross-sectional study was conducted using individual case safety reports (ICSRs) entered into the national pharmacovigilance database (VigiFlow) during 2017–2021. Results: Of 566 ICSRs, inconsistent reporting was seen, with the highest reporting in 2017 and 2019 (mass drug campaigns for deworming), zero reporting in 2018 (reasons unknown), and only a handful in 2020 and 2021 (since COVID-19). Of 566 ICSRs, 90% were for antiparasitics (actively reported during mass campaigns), while the rest (passive reporting from health facilities) included 8% antibiotics, 7% antivirals, and 0.2% antifungals. In total, 90% of the reports took >30 days to be entered (median = 165; range 2–420 days), while 44% had <75% of all variables filled in (desired target = 100%). There were 10 serious ADRs, 18 drug withdrawals, and 60% of ADRs affected the gastrointestinal system. The patient outcomes (N-566) were: recovered (59.5%), recovering (35.5%), not recovered (1.4%), death (0.2%), and unknown (3.4%). There was no final ascertainment of ‘recovering’ outcomes. Conclusions: ADR reporting is inconsistent, with delays and incomplete data. This is a wake-up call for introducing active reporting and setting performance targets.

Suggested Citation

  • 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.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:6:p:3264-:d:768149
    as

    Download full text from publisher

    File URL: https://www.mdpi.com/1660-4601/19/6/3264/pdf
    Download Restriction: no
    File URL: https://www.mdpi.com/1660-4601/19/6/3264/
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. 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.
    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. 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.
    2. 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.
    3. 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.
    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.

    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:gam:jijerp:v:19:y:2022:i:6:p:3264-:d:768149. 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: MDPI Indexing Manager (email available below). General contact details of provider: https://www.mdpi.com .

    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.