Future of Medical Education Journal

Future of Medical Education Journal

Pharmacovigilance: Ensuring Drug Safety and Patient Wellbeing, as an Elective in Competency-Based Medical Education Curriculum

Document Type : Original Article

Authors
Krushika Domadiya 1
Hitesh Chaudhari 2
Ankit Patel 2
Keyur Hirpara 2
Alpa Gor 2
Bharat Gajjar 2
1 Department of Pharmacology, Gmers Medical College, Junagadh, Gujarat, India
2 Department of Pharmacology, Pramukhswami Medical College Karamsad, Anand, Gujarat, India
10.22038/fmej.2025.89377.1663
Abstract
Background: The shift to competency-based medical education (CBME) has led to the introduction of targeted electives, such as pharmacovigilance, to enhance practical skills among medical students. This elective is vital for educating students on drug safety, therapeutic efficacy, and adverse drug reactions (ADRs). This study aimed to evaluate knowledge, attitudes, practical skills, and their importance in promoting patient safety and rational drug use among phase III part 1 medical students as an elective.
Method: A descriptive cross-sectional study was conducted in the Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India. A total of 22 students who have opted for pharmacovigilance as an elective were included in the study. Their knowledge (out of 10), attitude, completeness score (out of 10) of ADRs were reported and their feedback on course content, teachers' effectiveness and overall training were evaluated.
Results: The average multiple-choice question score was 7.8 out of 10. While 21 (95.5%) students believed that reporting ADRs is necessary and 17 (77.3%) thought it was mandatory, a total of 36 ADRs were identified with an average completeness score of 8.81 ± 0.56. Student feedback on the elective, assessed via a Likert scale, showed mean scores between 4.44 and 4.81, reflecting high satisfaction.
Conclusion: The elective posting effectively improves students' knowledge, attitudes and practical skills regarding the quality of ADR reporting in terms of completeness.
Keywords
Elective
Pharmacovigilance
Adverse Drug Reaction Reporting
Competency-Based Medical Education
Patient Safety
Subjects
  1. Cadogan CA, Ryan C, Hughes CM. Appropriate polypharmacy and medicine safety: when many is not too many. Drug Saf. 2016;39:109–16.
  2. Narwane SP, Agrawal PA, Mahavarakar VN. Evaluation of Elective Posting on Adverse Drug Reaction and Pharmacovigilance under Competency-based Medical Education Curriculum among Undergraduates: A New Step in Medical Education. J Datta Meghe Inst Med Sci Univ. 2024;19(2):330–4.
  3. Medical Council of India. Module on Electives for Undergraduate Medical Education Program 2020 [Internet]. 2020 [cited 2025 Jan 5]. p. 1–30. Available from: https://www.nmc.org.in/wp-content/uploads/2020/05/Electives-Module-20-05-2020.pdf
  4. Patil JS, Latha S, Patil V, Hugar L. Competency-Based Medical Education: Perception and Challenges among Students. J Datta Meghe Inst Med Sci Univ. 2023;18(1):63–9.
  5. Meher BR, Joshua N, Asha B, Mukherji D. A questionnaire-based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspect Clin Res. 2015;6(4):217–21.
  6. Guidelines for Implementation of New CBME Course Curriculum for MBBS Batch 2021‑22 Admitted in February‑March 2022. Nationa Medical Commission (Undergraduate Medical Education Board) Circular no.U.11026/1/2022‑UGMEB; 2022. [Internet]. [cited 2025 Jan 10]. Available from: https:/%0Awww.nmc.org.in/MCIRest/open/getDocument?path=/Documents/%0APublic/Portal/LatestNews/Implementation.pdf
  7. Mahajan MM, Thatte UM, Gogtay NJ, Deshpande S. An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India. Perspect Clin Res. 2018;9(3):123–6.
  8. Rehan HS, Sah RK, Chopra D. Comparison of knowledge, attitude and practices of resident doctors and nurses on adverse drug reaction monitoring and reporting in a tertiary care hospital. Indian J Pharmacol. 2012;44(6):699–703.
  9. Upadhyaya HB, Vora MB, Nagar JG, Patel PB. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat. J Adv Pharm Technol Res. 2015;6(1):29–34.
  10. Panneerselvam N, Kathirvelu P, Manoharan R. Impact of educational intervention on the knowledge, attitude, and practice of pharmacovigilance among postgraduates of a tertiary care center, Kanchipuram, Tamil Nadu, India. Perspect Clin Res. 2022;13(4):199–204.
  11. Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res. 2011;2(4):129–36.
  12. Schutte T, Tichelaar J, Reumerman MO, van Eekeren R, Rolfes L, van Puijenbroek EP, et al. Feasibility and educational value of a student-run pharmacovigilance programme: a prospective cohort study. Drug Saf. 2017;40:409–18.
Future of Medical Education Journal
Volume 15, Issue 4
Autumn 2025
Pages 14-18