Drug Safety - Pharmacovigilance: A Review

Pharmacovigilance (PV), also referred to as drug safety, encompasses the science and activities involved in detecting, assessing, understanding, and preventing adverse drug reactions (ADRs) and other drug-related issues1. As the global consumption of pharmaceutical products continues to rise, the importance of robust pharmacovigilance systems in ensuring drug safety has become increasingly critical. This review explores the evolution of pharmacovigilance, its global regulatory framework, and the methodologies employed in monitoring drug safety. It emphasizes the contributions of healthcare professionals, patients, and regulatory authorities in reporting ADRs, alongside the incorporation of advanced technologies such as big data analytics, artificial intelligence, and social media monitoring to enhance pharmacovigilance practices13. The review also addresses key challenges, including underreporting, data quality issues, and the growing complexity of new drug formulations. Looking ahead, the future of pharmacovigilance is expected to involve the adoption of more advanced signal detection techniques, enhanced patient-centered approaches, and greater international collaboration to strengthen drug safety on a global scale. This article aims to provide a comprehensive overview of pharmacovigilance and reporting requirements in several countries.