European Journal of Cardiovascular Medicine

Background Pharmacovigilance involves early detection of adverse drug reactions (ADRs) for safe use of drugs.This study assessed the awareness of ADR and its reporting among first year medical students, and the impact of sensitization program on their awareness at a tertiary care teaching hospital in Navi Mumbai.  Methodology In this cross-sectional study, we collected responses from a total of 202 first professional MBBS students using a 10-item self-reported questionnaire. The questionnaire included closed ended items validated before use. Afterpre-test, a 45-minute sensitization session on ADR reporting and pharmacovigilance was conducted. Post-testwith same questionnaire was held after the session. Absolute change in percentage of correct responses and improvement in the scores on three-point scale (improved, no change, decline) were assessed based on the change in the percentage score from pre-test to post-test assessment. Results Complete data available for 118 studentswere analyzed. The percentage of correct responses increased from 76.55% (pre-test) to 81.39% (post-test) after the sensitization session for (n=118). Thus, mean absolute scores improved significantly (4.84% improvement; p=0.003). Greatimprovements (% responders) was seen for the item (1) Are there separate ADR reporting forms for doctors and patients (46.6%)Improvement in scores was observed in 94 (79.7%), no change(1.7%), decline (18.6%). Conclusion Awareness about ADR and its reporting was considerable amongst medical students, and sensitization session further improved the awareness.Early sensitization andfrequent short sessions are needed to improve ADR reporting among health care workers and professionals.