Pharmacovigilance and Adverse Drug Reaction Monitoring in Post-Marketing Surveillance

Abstract

Pharmacovigilance (PV) has become an indispensable component of public health systems across the globe, particularly as concerns about drug safety continue to grow. Post-marketing surveillance (PMS), which includes the ongoing monitoring of drug safety after approval, plays a vital role in identifying, assessing, and preventing adverse drug reactions (ADRs). Despite rigorous preclinical and clinical trials, unforeseen ADRs may arise only after large-scale use. This paper explores the mechanisms, tools, and challenges associated with pharmacovigilance in PMS. A comprehensive literature review and comparative analysis of global regulatory frameworks are presented, along with an evaluation of spontaneous reporting systems, electronic health records, and modern signal detection technologies. The study also examines the integration of artificial intelligence (AI) in ADR detection and the impact of pharmacovigilance in refining clinical guidelines. This paper emphasizes the urgent need for robust pharmacovigilance programs, healthcare professional training, and patient involvement to ensure drug safety and effective therapeutic outcomes.

DOI: 10.8612/40.3.2025.2