Pharmacovigilance: An Essential Approach to Medicine Safety, ADR Reporting and Risk Management

Abstract

Pharmacovigilance is an important branch of pharmaceutical and medical science concerned with the continuous monitoring of the safety and proper use of medicines. It includes the detection, collection, monitoring, assessment, understanding and prevention of adverse drug reactions (ADRs) and other medicine-related problems. Clinical trials cannot identify every possible adverse effect because medicines are studied in limited populations and for limited periods. Post-marketing monitoring is therefore essential for identifying rare, unexpected and long-term safety problems. This review summarizes the major concepts of pharmacovigilance, ADR classification and reporting, spontaneous reporting systems, documentation, causality assessment, signal detection, risk management and the role of pharmacists. The review also discusses the importance of patient safety, medication-error monitoring and the Pharmacovigilance Programme of India (PvPI). Effective and timely ADR reporting, accurate documentation, continuous safety monitoring and appropriate risk-minimization measures are essential for maintaining a favorable benefit–risk balance and promoting the safe and rational use of medicines.

Keywords: Pharmacovigilance; Adverse Drug Reactions; ADR Reporting; Signal Detection; Risk Management; Risk Management Plan; Patient Safety; Pharmacist; PvPI.