Evidence map›Paper›PMID 41807284›Full record

ArticlePharmacoepidemiology and drug safety2026

Trends and Patterns of Adverse Drug Reaction Reporting in Sierra Leone: A Retrospective Analysis of VigiFlow Data (2008-2022).

Isatu Jalloh, Onome Thomas Abiri, Peter Bai James, Rajesh Vagiri, Neelaveni Padayachee

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Article in Pharmacoepidemiology and drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1 · What the graph read from it

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1 citing paper in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Isatu JallohDepartment of Pharmacy and Pharmacology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0009-0005-3109-0576
Onome Thomas AbiriDepartment of Pharmacology and Therapeutics, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Peter Bai JamesNational Centre for Naturopathic Medicine, Faculty of Health, Southern Cross University, Pharmacy Board of Sierra Leone, Lismore, Australia.
Rajesh VagiriDivision of Pharmacology, Faculty of Pharmacy, Rhodes University, Makhanda, South Africa.
Neelaveni PadayacheeDepartment of Pharmacy and Pharmacology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAdverse drug reactions (ADRs) present significant obstacles for healthcare systems, impacting both patient safety and the effectiveness of treatments. Despite this, there is a scarcity of research on ADR reports in Sierra Leone, especially over long periods. This study aims to investigate the characteristics and reporting patterns found in the Sierra Leone pharmacovigilance database managed through VigiFlow.

methodThis study analyzes reports of ADRs from Sierra Leone's national pharmacovigilance database, VigiFlow, spanning from January 2008 to December 2022. Data collected included patient demographics (age, sex), reporter characteristics (type of reporter, year of reporting), and ADR-specific information (suspected medication, indication, ADR types (MedDRA), seriousness, outcome, actions taken, and time to onset), and completeness score. Descriptive statistics, chi-square tests, and the Kruskal-Wallis test with Bonferroni-adjusted post hoc tests were applied to identify patterns and associations within the dataset.

resultsA total of 3381 individual case safety reports (ICSRs) were analysed. The majority of reports involved females (54.7%) and adults aged 18 to 44 years (51.4%). Reporting rates increased after 2015, peaking in 2021. The most frequently implicated medications were anti-infective drugs (40.7%) and antiparasitic medicines (34.1%), particularly ivermectin, albendazole, and vaccines for cholera and yellow fever. The most commonly reported ADRs were headache (13.2%), fever (12.2%), and diarrhoea (7.6%), primarily affecting the nervous system and general disorder classes. Pharmacists were responsible for 39.0% of reports and achieved the highest completeness score, with a mean of 0.78. Age was significantly associated with the seriousness, outcome, and onset time of ADRs (p < 0.001), while gender was significantly associated with onset time (p = 0.007).

conclusionADR reporting in Sierra Leone has improved, with antiparasitic medicines and vaccines most frequently linked to reactions. Sustaining progress requires enhanced training, public engagement, and strengthened active pharmacovigilance to ensure completeness and patient safety.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsPharmacovigilanceAdolescentAdultAgedChildChild, PreschoolDatabases, FactualFemaleHumansInfantMaleMiddle AgedRetrospective StudiesSierra Leoneadverse drug reactionscompleteness scoreindividual case safety reportspharmacovigilanceSierra LeoneVigiFlow

Identifiers

PMID41807284
PMCPMC12975695

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