Adverse drug reaction reporting and monitoring: A review of global practices

The negative drug reactions (ADRs) are a major challenge to the global health due to their contribution to morbidity and mortality as well as the increased healthcare expenditure. Therefore, it is of interest to explore the international contextual situation of ADR reporting and monitoring systems, their development, their presence in the market, and their future perspectives. The review provides an overview of different pharmacovigilance frameworks put in place by international organizations and national regulatory bodies and their weaknesses and strengths. It was found that despite the tremendous progress achieved in the formation of global pharmacovigilance networks, much still needs to be done in the detection, reporting, and prevention of ADRs especially in the low and middle-income countries. The review identifies new trends and possible innovations that can change ADR monitoring in the decade and provide patient- centered reporting, integrate real-world evidence, and predictive toxicology methods.