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


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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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