Enhancing Pharmacovigilance and Drug Safety Monitoring: Trends, Challenges, and Future Directions in Global Healthcare Systems

Abstract

Pharmacovigilance has become an essential pillar of modern healthcare, aiming to monitor, detect, and prevent adverse drug reactions (ADRs). The rapid evolution of pharmaceuticals—including biologics, precision medicine, and complex drug formulations—has necessitated a shift from traditional post-marketing surveillance to data-driven, real-time monitoring systems. Advanced technologies such as artificial intelligence (AI), machine learning (ML), blockchain, and real-world evidence (RWE) have emerged as crucial tools in pharmacovigilance, improving ADR signal detection, regulatory compliance, and patient safety. However, despite these advancements, challenges persist, including underreporting of ADRs, fragmented regulatory frameworks, data privacy concerns, and disparities in global pharmacovigilance infrastructure. This paper explores the current trends, key barriers, and future strategies for strengthening pharmacovigilance. By analyzing data from the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and peer-reviewed studies, this review highlights the role of AI-driven pharmacovigilance, big data analytics, patient-centered reporting mechanisms, and pharmacogenomics in enhancing drug safety. The study ultimately underscores the need for harmonized global regulations, increased healthcare professional engagement, and integration of emerging digital health solutions to build a proactive and resilient pharmacovigilance system worldwide.