TY - CHAP
T1 - Evidence-based pharmacovigilance for medicines used in public health programs in africa
AU - Ampadu, Haggar Hilda
AU - Esseku, Yvonne
AU - Dodoo, Alexander N.O.
N1 - Publisher Copyright:
© Springer Science+Business Media, LLC, part of Springer Nature 2018.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
KW - African countries
KW - Cohort event monitoring
KW - Pharmacovigilance
KW - Safety data
KW - Targeted spontaneous reporting
KW - World Health Organization (WHO)
UR - http://www.scopus.com/inward/record.url?scp=85055738822&partnerID=8YFLogxK
U2 - 10.1007/978-1-4939-8818-1_10
DO - 10.1007/978-1-4939-8818-1_10
M3 - Chapter
AN - SCOPUS:85055738822
T3 - Methods in Pharmacology and Toxicology
SP - 185
EP - 199
BT - Methods in Pharmacology and Toxicology
PB - Humana Press Inc.
ER -