INTRODUCTION Rational drug use is essential for patient safety, yet adverse drug reactions (ADRs)–defined by the World Health Organization (WHO) as harmful and unintended responses of drugs at normal therapeutic doses – remain a significant clinical and public health challenge.1 ADRs occur in 4.6%–17.6% of hospitalized patients and contribute to considerable morbidity, mortality, and healthcare costs.2 Strengthening pharmacovigilance (PV) systems, including PV Programme of India (PvPI), is therefore critical for improving ADR detection and reporting. With ADR reporting now integrated into the Competency-based Medical Education (CBME) curriculum, assessing medical students’ knowledge, attitudes, and practices (KAPs) is necessary to identify the gaps and enhance training. This study evaluates MBBS students’ KAP regarding PV, to identify the gaps and determine the need for further training. MATERIALS AND METHODS This study was conducted at a tertiary care teaching hospital in Odisha after approval from the Institutional Ethics Committee (No. 1473/Chairman-IEC/MKCG). A cross-sectional, questionnaire-based design was conducted from February to May 2024. A total of 375 MBBS students aged ≥19 years who provided informed consent were included. Of these, 75 students (25 from each phase) formed the pilot group and 300 students (100 from each phase) constituted the main cohort. Data were collected using a self-administered, validated 36-item questionnaire2,3 (Microsoft Forms) assessing KAP, demographics, and perceptions related to PV within the CBME curriculum. Questionnaire development followed the Lynn Method, with items derived from WHO, PvPI, UMC, and NMC-CBME guidelines.4 Content validation by ten experts showed strong agreement, with an I-Content Validity Index (CVI) of 0.92, S-CVI of 0.91 and a mean Content Validity Ratio of 0.82 using the Lawshe Method;5 35 of 36 items met required criteria. Construct validity was established through Exploratory Factor Analysis of pilot data (Kaiser-Meyer-Olkin = 0.84; Bartlett’s test P < 0.001). Reliability analysis demonstrated high internal consistency. Data were analyzed using the SPSS software version 26 (IBM Corp., Armonk, NY) using descriptive statistics and Chi-square or Fisher’s exact tests, with P < 0.05 considered significant. RESULTS Among the 300 MBBS students who completed the questionnaire, 59.5% were male and 40.5% were female. Most Phase 2 (30.4%) and Phase 3 Part I (24.3%) students were aged 19–22 years, whereas the majority in Phase 3 Part II were 23–25 years (16%), with 9.34% older than 25 years. Overall, 72.7% of students correctly defined “Pharmacovigilance,” with the highest proportion from Phase 3 Part I. Only 46.1% accurately defined an ADR, mainly from Phase 3 Part II. The correct knowledge of ADR reporting methods was observed in 46.13%, primarily from Phase 2. A large majority (80.27%) correctly identified who can report ADRs, and 62.93% knew when to report them. Awareness of the National Coordination Center and the Uppsala Monitoring Center was reported by 78.93% and 72%, respectively. Knowledge of causality assessment was noted in 81.6%, while 59.73% were aware of Will’s and Brown’s Classification. Notably, 93.87% supported establishing a PV unit in every medical college. Students demonstrated a highly positive attitude: 98.13% agreed that ADR reporting is necessary and 98.08% considered it a professional responsibility. Adequate training was reported by 83%, with 97.67% supporting formal PV training and 93% endorsing installation of ADR reporting boxes. Although 92.4% had received ADR training and 94.53% had seen forms, 57.73% had never encountered an ADR and 66.27% had never reported one. Interest in additional training was expressed by 87.33% and 99.16% believed reporting improves patient safety. While 56.34% had visited the ADR Monitoring Center, 94.27% felt encouraged by their institution. The key barriers included limited patient information (38.18%) and insufficient promotion of ADR reporting (19.78%). DISCUSSION This study evaluated MBBS students’ KAP toward PV and compared the findings with Venepally2 and Meher et al.3 Knowledge levels were moderate: 46.13% correctly defined ADRs, lower than Meher et al.3 (67.8%) and Venepally et al.2 (76.5%). Awareness of “Who can report ADRs” was higher (80.27%) than Meher et al. (69.4%) and Venepally et al. (45%). Correct PV definition was achieved by 72.7%, exceeding Meher et al. (51.6%) but slightly below Venepally et al. (92%). Awareness of the Uppsala Monitoring Center (72%) was also higher than Meher et al. (46.11%). Furthermore, 93.87% supported establishing PV units, closely aligning with Venepally et al. (98.5%). Attitudes were overwhelmingly positive. Nearly all students (98.13%) agreed ADR reporting is necessary, comparable to Meher et al. (95.5%) and 98.08% viewed it as a shared professional responsibility, substantially higher than Meher et al. (23.8%). In addition, 97.67% advocated strengthening PV education. Practice outcomes were relatively limited. Only 42.27% had encountered an ADR, lower than Meher et al. (76.1%) and Venepally et al. (65%). However, ADR reporting participation (33.73%) exceeded Meher et al. (11.1%) and visits to ADR Monitoring Centers (56.34%) were higher than prior reports. CONCLUSION Undergraduate medical students demonstrated strong knowledge and positive attitudes toward PV, but limited practical exposure underscores the need for structured hands-on training, workshops, and experiential learning to enhance ADR reporting competence. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Biswas et al. (Thu,) studied this question.