Data Driven vigiPoint Identification Study of Adverse Event Reporting Patterns for Zimbabwe Reports in VigiBase WHO Global Database of Individual Case Safety Reports for Medicines and Vaccines

Author(s): Priscilla P.M. Nyambayo, Michael S. Gold, Ushma C. Mehta

vigiPoint: Data driven analytic tool was developed by the Uppsala Monitoring Centre(UMC) to identify key features of VigiBase Individual Case Safety Reports (ICSRs) data subsets. Zimbabwe contributed ICSRs into VigiBase since 1998 hence the importance to understand the reporting patterns of Zimbabwe ICSRs compared to the rest of the world’s (RoW) data with and without the USA reports, which contributes 48% ICSRs to VigiBase.

Objective: The study explored vigiPoint differences in the Zimbabwe medicines and vaccines ICSRs reporting patterns compared to the RoW with and without the USA reports.

Methods and Materials: The study used vigiPoint analysis for VigiBase ICSRs reports analysis to outline data subsets of interest, pinpointing outstanding key features, using odds ratios subjected to statistical shrinkage distinguishing one data subset from another. The vigiPoint methodology compared 5213 Zimbabwe ICSRs reports in VigiBase from 1998-2022 with RoW with and without the USA unduplicated reports. To highlight features that deviate from the expected only, the threshold for the credibility interval of the log odds ratio was set at 0.5 and −0.5, respectively. The shrinkage was set to the vigiPoint default corresponding at 40% of the size of the Zimbabwe unduplicated ICSRs data subset.

Results: A total of 5213 ICSRs (20% vaccines AEFIs, and 80% medicines AEs) were analysed using VigiPoint method. Zimbabwe ICSRs compared with RoW and without USA ICSRs reports had most reports submitted from nurses, AEs for people age ranges 18-44 years (43.1 vs 30.7%), infants and children 1-23 months (13.8 vs 3.0%) and children 2-11 years (12.1 vs 4.0%). Zimbabwe ICSRs were serious 71.6% vs 35.8% RoW mostly cosuspected antiretrovirals, antituberculosis medicines, or vaccines.

Conclusion: Study findings are characteristic of limited healthcare settings, like other studies that found low physician-patient ratio, higher rates of HIV, TB, and comorbid diseases. Further studies of Zimbabwe ICSRs causality assessment outcomes including use of mHealth to enhance consumers/HCWs reporting are required.