Abstract

PHARMACOVIGILANCE AND ADVERSE DRUGS REACTION

Shravan Kumar*, Mrs. Jyoti Kumari*, Rajaram R. Rajbhar*

ABSTRACT

Pharmacovigilance, a scientific discipline of the public health and medicine. The primary goal is the detection, evaluation, understanding and prevention of ADRs and other drug-related problems. ADRs are a significant cause of patient morbidity and mortality, prolongs hospitalization and increases the burden of health expenditure. Despite providing valuable safety information, clinical trials may not adequately identify all the adverse events, thus a continuous monitoring of drugs post-marketing is necessitated. This article highlights the principles, scope and regulatory aspects of Pharmacovigilance, and underscores its significance with the contribution of healthcare professional, spontaneous reporting system and national and international Pharmacovigilance Programs in the safety of medicines. This is a comprehensive review of the publishedliterature, WHO guidelines, Pharmacovigilance Program of India (PvPI) documents, and regulatory sources with information concerning to the reporting of ADRs, PV systems, healthcare provider's awareness, regulatory bodies and the management of risk. Effective Pharmacovigilance can contribute to enhancing patient safety by enabling early identification of ADRs, continuing the risk-benefit evaluation, and putting risk minimization actions in place. Nevertheless, the underreporting of ADRs still persists due to insufficient knowledge, insufficient training, lack of reporting culture among the health care professionals. Augmentation of PV infrastructures, continuing educational programs and increasing spontaneity of ADR reporting can effectively improve drug safety outcomes. Pharmacovigilance is a fundamental and an indispensable part of the health care sector, contributing to the safe use of medicines along their life cycle, and plays a critical role in maintaining patient confidence.

Keywords: Pharmacovigilance; Adverse Drug Reactions (ADRs); Drug Safety; Adverse Drug Reaction Reporting; Post-Marketing Surveillance; Pharmacovigilance Programme of India (PvPI); Healthcare Professionals; Medication Safety; Risk Management; World Health Organizati