Pharmacovigilance, defined by the World Health Organization (WHO) as “the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems,” plays a vital role in ensuring drug safety across healthcare systems worldwide [1]. This discipline was initially established following significant public health crises, most notably the thalidomide tragedy in the 1960s, which underscored the need for systematic drug safety monitoring [2]. The catastrophic effects of thalidomide, primarily used as a sedative in pregnant women, led to thousands of congenital disabilities, ultimately sparking regulatory changes that laid the foundation for modern pharmacovigilance practices [3]. Pharmacovigilance not only focuses on adverse drug reactions (ADRs) but also encompasses broader risk management, which includes tracking, evaluating, and mitigating risks associated with medicinal products. Given the complex landscape of drug safety, pharmacovigilance now involves an interdisciplinary approach, including clinical pharmacy, regulatory science, epidemiology, and data analytics [4]. The goal is to enhance patient safety by continuously assessing the risk-benefit profile of medicinal products as they are developed, tested, approved, and made available in real-world settings [5].
Akanksha Punekar*
10.5281/zenodo.17563807