EFFECT OF A SIMULATION-BASED PHARMACOVIGILANCE AND ADR REPORTING MODULE ON KNOWLEDGE AND SKILLS AMONG FINAL-YEAR MBBS STUDENTS: A QUASI-EXPERIMENTAL STUDY

Background: Pharmacovigilance training in undergraduate medical education remains largely theoretical, leading to inadequate real-world reporting competency. Simulation-based training may help bridge this gap. Aim: To evaluate the effectiveness of a structured simulation-based pharmacovigilance module in improving knowledge and ADR-reporting skills among final-year MBBS students. Methods: A quasi-experimental single-group pre-test/post-test study was conducted among 45 final-year MBBS students. The intervention comprised interactive lectures, case-based simulations, and ADR form-filling exercises over four days. Knowledge was assessed using a validated 15-item MCQ test; skills were assessed using an OSPE checklist based on CDSCO ADR reporting formats. Paired t-test was used for statistical comparison. Results: Mean MCQ scores improved significantly from 11.45 ± 3.90 to 13.18 ± 3.20 after the module (p = 0.015; Cohen’s d = 0.88). The proportion of students achieving high scores (13–15) increased from 36% to 60%. OSPE scores improved from 5.2 to 8.1, demonstrating enhanced ability to identify ADRs and complete reporting forms accurately. Conclusion: The simulation-based pharmacovigilance module substantially improved theoretical knowledge and practical ADR-reporting skills among MBBS students. Such structured educational models may strengthen pharmacovigilance competency in undergraduate medical training.