Original Research

The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®

Mafora F. Matlala, Martha S. Lubbe, Hanlie Steyn
African Journal of Primary Health Care & Family Medicine | Vol 15, No 1 | a3659 | DOI: https://doi.org/10.4102/phcfm.v15i1.3659 | © 2023 Mafora F. Matlala, Martha S. Lubbe, Hanlie Steyn | This work is licensed under CC Attribution 4.0
Submitted: 11 May 2022 | Published: 18 January 2023

About the author(s)

Mafora F. Matlala, Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa; and Pharmacovigilance Unit, South African Health Products Regulatory Authority, Pretoria, South Africa
Martha S. Lubbe, Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa
Hanlie Steyn, Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa

Abstract

Background: Spontaneous reporting is regarded as a cornerstone of pharmacovigilance (PV) but presents many limitations, including varying quality and completeness of information, which is essential for causality assessment.

Aim: This study aimed to evaluate the completeness of adverse drug reaction (ADR) reports in South Africa based on the vigiGrade completeness score.

Setting: The South African Health Products Regulatory Authority (SAHPRA).

Methods: A cross-sectional, descriptive study of all reports received by SAHPRA and submitted to VigiBase® in 2017 was conducted. A report with a vigiGrade score > 0.8 is considered well-documented.

Results: The mean completeness score for the 8438 reports received was 0.456 (s.d. = 0.221). Only 11.3% of reports had a completeness score > 0.8. The completeness of reports submitted by consumers professionals did not significantly differ from reports by physicians, pharmacists or other healthcare professionals (d ≤ 0.2). Reports of reactions that resulted in death (M = 0.572, s.e. = 0.007), disability (M = 0.491, s.e. 0.033) or were life threatening (M = 0.474, s.e. = 0.013) had a medium to large practically significant effect (0.5 ≥ d ≤ 0.8) on the completeness score compared with reports of congenital anomaly (M = 0.348, s.e. = 0.089).

Conclusion: The completeness of reports submitted by consumers is comparable to those submitted by healthcare professionals. The completeness of reports was low and multiple measures to improve reporting are recommended.

Contribution: This study describes the completeness of ADR reports in South Africa and the results can be used to improve training.


Keywords

pharmacovigilance; adverse drug reactions; reports; completeness; South Africa; individual case safety report.

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Crossref Citations

1. Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Patrick Christ, Diana Dubrall, Matthias Schmid, Bernhardt Sachs
Drug Safety  vol: 46  issue: 12  first page: 1363  year: 2023  
doi: 10.1007/s40264-023-01355-8