Abstract

PHARMACOVIGILANCE, ADR REPORTING AND IT’S AWARENESS

*Ghevare Omkar Dilip, Mr. Shivraj Suryawanshi, Dr. Ganesh S. Tolsarwad

Abstract

Pharmacovigilance (PV) plays a vital role in ensuring the safe and rational use of medicines after they reach the market. Adverse drug reactions (ADRs) remain a major cause of morbidity, mortality and healthcare burden worldwide. Despite well-established regulatory frameworks, under-reporting of ADRs continues to be a global challenge. The lack of awareness, insufficient training, inadequate reporting infrastructure and low perception of reporting importance are among the major barriers faced by healthcare professionals and patients. This review discusses the burden of ADR-related morbidity and mortality, the methods used to quantify ADRs, available ADR reporting systems, and the challenges associated with them. The review also highlights the applications of pharmacovigilance in improving patient safety and provides recommendations to promote ADR reporting culture and awareness. Adverse drug reactions (ADRs) are a major global public health challenge, contributing significantly to morbidity, mortality, and economic burden across healthcare systems worldwide. Pharmacovigilance, defined as the science and activities relating to the detection, assessment, understanding, and prevention of ADRs, plays a crucial role in ensuring medication safety and protecting patient health. Studies estimate that ADRs account for 5–10% of hospital admissions, prolong hospital stay by 2–9 days, and represent one of the leading causes of death in many countries. Despite the establishment of structured reporting systems such as the WHO Programme for International Drug Monitoring and national bodies like India’s Pharmacovigilance Programme (PvPI), underreporting remains a universal issue, with only 5–10% of actual ADRs reported globally Multiple factors—including lack of awareness, insufficient training, fear of legal implications, lack of time, and uncertainty about causality—continue to hinder the effectiveness of pharmacovigilance activities.

Keywords: Pharmacovigilance, Adverse Drug Reactions, ADR Reporting, PvPI, Awareness, Patient Safety, Drug Safety, Spontaneous Reporting.