Understanding the Role of Pharmacovigilance in Patient Safety

Abstract

Pharmacovigilance (PV) plays a vital role in ensuring patient safety by monitoring the safety and efficacy of medicines throughout their lifecycle. Post-marketing surveillance helps identify adverse drug reactions (ADRs) and drug-related problems that may not have been detected in clinical trials due to their limited scope and population. PV involves the collection, assessment, and analysis of ADR data, often reported by healthcare professionals, patients, and pharmaceutical companies. Regulatory bodies like the FDA and EMA, alongside global organizations such as the WHO, work collaboratively to detect and manage potential drug safety issues. Despite its importance, PV faces challenges, including underreporting of ADRs and the complexity of determining causality. However, its impact on patient safety is profound, as it enables timely interventions, improves therapeutic decisions, and enhances public health outcomes. Continuous advancements in pharmacovigilance practices are crucial for the ongoing safety of medicines and protection of public health.