Beyond Adverse Drug Reactions: the Evolving Landscape of Pharmacovigilance in Ensuring Medication Safety

Abstract

Pharmacovigilance has evolved from focusing solely on adverse drug reaction (ADR) reporting to a comprehensive, patient-centered approach that ensures medication safety throughout a drug's life cycle. It now includes the monitoring of medication errors, drug interactions, vaccine safety, materiovigilance, and continuous benefit–risk assessment. Advances in artificial intelligence, machine learning, big data, electronic health records, digital reporting, and real-world evidence have strengthened signal detection and regulatory decision-making. However, challenges such as under-reporting, poor data quality, privacy concerns, and unequal pharmacovigilance infrastructure remain. Enhancing global collaboration, increasing the involvement of healthcare professionals and patients, and adopting advanced digital technologies are essential for improving medication safety and protecting public health.