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.
Afr J Prim Health Care Fam Med. 2023 Jan 18;15(1):e1-e9. doi: 10.4102/phcfm.v15i1.3659.
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.
This study aimed to evaluate the completeness of adverse drug reaction (ADR) reports in South Africa based on the vigiGrade completeness score.
The South African Health Products Regulatory Authority (SAHPRA).
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.
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).
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.
自发报告被视为药物警戒（PV）的基石，但存在许多局限性，包括信息的质量和完整性各不相同，这对于因果关系评估至关重要。
本研究旨在根据 vigiGrade 完整性评分评估南非不良药物反应（ADR）报告的完整性。
南非卫生产品监管局（SAHPRA）。
对 2017 年由 SAHPRA 收到并提交给 VigiBase®的所有报告进行了一项横断面、描述性研究。 vigiGrade 得分为 0.8 的报告被认为记录完整。
收到的 8438 份报告的平均完整性评分为 0.456（标准差=0.221）。只有 11.3%的报告完整性评分为 0.8。消费者专业人员提交的报告的完整性与医生、药剂师或其他医疗保健专业人员提交的报告没有显著差异（d ≤ 0.2）。导致死亡（M = 0.572，标准误=0.007）、残疾（M = 0.491，标准误 0.033）或危及生命（M = 0.474，标准误=0.013）的反应报告的完整性评分与先天性异常报告（M = 0.348，标准误 0.089）相比具有中等至较大的实际显著影响（0.5≥d≤0.8）。
消费者提交的报告的完整性与医疗保健专业人员提交的报告相当。报告的完整性较低，建议采取多项措施提高报告质量。
本研究描述了南非 ADR 报告的完整性，研究结果可用于改进培训。
