Pharmacovigilance and its impact on drug safety

Abstract

Pharmacovigilance is the science and activities concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug related problems. Pre-marketing clinical trials provide essential information on efficacy and safety of drugs. they are limited by small sample size and short durations which makes post-marketing surveillance crucial for identifying, rare, serious and long-term adverse drug reactions. Pharmacovigilance systems rely on spontaneous reporting, active surveillance and pharmacoepidemiological studies to generate safety signals and support regulatory decision making. Effective pharmacovigilance contributes to the rational use of medicines, enhances patient safety, and improves public health outcomes through continuous monitoring of benefit-risk ratio of medicinal products. Strengthening reporting systems and increasing awareness among healthcare professionals and patients remain key to improving pharmacovigilance practices globally.