Abstract

MATLALA, Mafora F.; LUBBE, Martha S.  and  STEYN, Hanlie. The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®. Afr. j. prim. health care fam. med. (Online) [online]. 2023, vol.15, n.1, pp.1-9. ISSN 2071-2936.  http://dx.doi.org/10.4102/PHCFM.V15I1.3659.

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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