Evidence-based pharmacovigilance for medicines used in public health programs in africa

Pharmacovigilance in Africa has grown sharply this millennium with the number of African countries joining the World Health Organisation (WHO) Programme for International Drug Monitoring having increased from just 5 in the year 2000 to 35 in 2017. However, published information indicates that Africa’s contribution of individual case safety reports (ICSRs) to the WHO ICSR database (VigiBase) is paltry currently standing at less than 1% of the >14 million ICSRs in VigiBase. Moreover, there is little evidence of African countries collecting, analyzing, and using data from their settings to inform pharmacovigilance and drug safety decisions in their own countries. The huge doses of medicine and vaccines deployed for public health programs including those against malaria, tuberculosis, and HIV/AIDS as well as those for infant immunization against preventable diseases means that there is opportunity to collect real world data in relation to these medicines and vaccines. Spontaneous reporting may not necessarily be the best approach in the various African countries considering the high under-reporting associated with all spontaneous reporting schemes globally. However, there are opportunities to utilize more active pharmacovigilance approaches including cohort event monitoring and targeted spontaneous reporting to improve collection and use of safety data in Africa to improve patient care, especially in public health programs in Africa.