2023, Vol. 5, Issue 1, Part B

Introduction: The primary objective of this study is to assess the knowledge, attitude and awareness of adverse drug reaction reporting process among Indian medical undergraduates in a tertiary care teaching hospital.

Material and Methods: This is a cross sectional questionnaire based study on 250 Indian medical graduates. Phase III – Part 1 and Part 2 Medical Undergraduates at Trichy SRM Medical College Hospital & Research Centre for next 3 months were included. The students were informed in person with participant information sheet during PHASE 3 clinical posting. Those students who did not gave informed consent for participation in the study were excluded.

Results: The mean age of the study participants was 20.12±1.3 years. There was male preponderance with 52% male medical graduates and 48% female medical graduates. Majority of the included subjects were in Phase III Part 1. Table 1 describe the distribution of knowledge related questions. Around 70% correctly answered the definition of pharmacovigilance, 40% answered about important purpose of pharmacovigilance, 48% on healthcare professionals are responsible for reporting ADRs, 61% on organization conducting National Pharmacovigilance Program in India, 40% on regulatory body responsible for monitoring pharmaceuticals and medical devices, 42% answered correctly on location of international centre for adverse drug reaction monitoring.

Conclusion: There is requirement for continuous medical education in these students on regulations of Pharmacovigilance. This study provides baseline data of the knowledge and attitude for providing educational intervention.