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

TL;DR

This paper reviews global practices in monitoring and reporting adverse drug reactions, highlighting progress and challenges in improving patient safety.

Contribution

The paper identifies new trends and innovations in ADR monitoring, such as patient-centered reporting and predictive toxicology.

Findings

Global pharmacovigilance networks have made progress, but significant gaps remain in ADR detection and reporting.

Low and middle-income countries face particular challenges in ADR monitoring and prevention.

Emerging innovations could enhance ADR monitoring through real-world evidence and predictive methods.

Abstract

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.