Knowledge, Attitude and Practice of Pharmacovigilance Among Undergraduate Medical Students

Abstract

Pharmacovigilance (PV) is essential for ensuring drug safety by detecting, assessing, and preventing adverse drug reactions (ADRs). Despite its importance, ADR underreporting remains a global issue, with rates as high as 90–95%. Medical students, as future healthcare providers, play a crucial role in ADR reporting; however, gaps in their knowledge, attitude and practice (KAP) persist.This study aims to assess the KAP of PV among undergraduate medical students, identify barriers to ADR reporting and propose strategies for enhancing PV education. A cross-sectional study was conducted among 368 MBBS students at KMCH Institute of Health Sciences and Research, Coimbatore, Tamilnadu, India. A structured questionnaire assessed demographic details, knowledge (9 items), attitude (6 items) and practice (11 items) regarding PV. Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 27.0. Among the participants, 60.9% were female and 42.9% were under 20 years old. While 77.7% correctly defined PV, only 53.8% recognised the role of clinical trials in detecting rare ADRs. Awareness of India’s PV programme was moderate (66.8%), but only 45.1% had seen an ADR reporting form. Although 95.1% of students believed ADR reporting was necessary, only 5.7% had reported an ADR, highlighting a gap between awareness and practice. Key barriers included lack of training (66.6%), limited awareness of ADR monitoring centres (20.4%) and low utilisation of digital reporting tools (4.9%). Despite a positive attitude toward ADR reporting, practical engagement remains low due to insufficient training and regulatory awareness. Structured educational interventions can enhance PV practices among medical students.