Assessment of pharmacovigilance approaches for monitoring the safety of antimalarial drugs in pregnancy

Post-marketing surveillance of drugs used in pregnancy is challenging, especially in developing countries where resources for pharmacovigilance are rare. There is a need to establish simple but effective systems to monitor safety of drugs given during pregnancy in resource constrained countries. Although ACTs are not recommended in early stages of pregnancy, inadvertent exposures to ACTs are unavoidable; this will occur through different channels including outpatient clinics, the informal sector, clinical trials or mass drug administration programmes because either the woman or the prescriber is unaware of her pregnancy status. Deliberate exposures will occur in situations where the benefit outweighs the potential risk, when no other effective antimalarial drugs are available and particularly in the case of severe malaria. There are currently no established systems to monitor drug safety in pregnancy in malaria endemic countries. The aim of this thesis was to develop and evaluate pharmacovigilance systems in resource constrained settings to provide a better estimate of the risk-benefit profile of ACTs in pregnancy.