Meeting South Africa's pharmacovigilance challenges in the face of rapidly increasing public health treatment programmes.

Abstract

Among South Africa‘s (SA‘s) many public health challenges, having the largest treatment programmes globally is a significant challenge. The latter requires a robust pharmacovigilance (PV) programme. The purpose of this study was to conduct a review of the PV landscape in SA to meet the PV challenge of these treatment programmes. Aims and Objectives The aim of this study was to explore the decentralised PV approach to support key public health programmes. The specific objectives were firstly, to trace and reconstruct the history of PV activities to date. Secondly, to benchmark the current PV activities through an appropriate baseline assessment. Thirdly, to determine the impact of a PV training intervention. And finally, to evaluate the effectiveness of a low cost SAspecific PV strategy implemented in response to major public health challenges, namely HIV/AIDS and tuberculosis, through analysis of the data collected. Methodology This thesis followed a mixed methods approach including a literature survey, a structured questionnaire-based evaluation (baseline and before- and after-training assessments) and finally a retrospective review of ADR reports. Results The study reviewed published and grey literature to reconstruct the evolution of pharmacovigilance in SA. Through a baseline assessment in Eastern Cape Province, it also demonstrated areas that need strengthening and provided recommendations of simple, cost-effective interventions to close these gaps in that province, as well as generally in SA. Training, a key intervention recommended, was also tested and the study found a positive shift in knowledge gained by healthcare professionals (HCPs) from a one-day pharmacovigilance training intervention (p<0.002). Finally, a retrospective analysis of ADR data collected was conducted. Among others, this revealed the effectiveness of this low cost PV programme in detecting top causative agents, most common ADRs and their incidence across gender. Conclusions This study provided a review of the PV landscape in SA. The findings have the potential to inform treatment guidelines. Scaling up the methods used herein has the potential to detect trends that can be acted upon to reduce morbidity and mortality from large public health treatment programmes, especially in low-income settings.