EVALUATING PHARMACOVIGILANCE AWARENESS AND ADVERSE DRUG REACTION REPORTING AMONG UNDERGRADUATE HEALTHCARE STUDENTS FOLLOWING A STRUCTURED EDUCATIONAL PROGRAMME

Abstract

Background: Despite continued progress in pharmaceutical development and regulatory surveillance, adverse drug reactions (ADRs) remain an important concern for healthcare systems. Successful pharmacovigilance relies substantially on healthcare professionals being able to identify suspected ADRs, record the relevant information, and report such events appropriately. As these essential skills and attitudes begin to develop during undergraduate training, evaluating pharmacovigilance awareness among future healthcare professionals and improving their knowledge in this area are important measures for promoting safer medication use and enhancing patient safety. Objective Primary objective: To evaluate participants’ knowledge and awareness of pharmacovigilance and adverse drug reaction (ADR) reporting following completion of a structured educational intervention. Secondary objectives: To describe previous exposure to ADRs, awareness of ADR reporting, attitudes toward compulsory reporting and curricular inclusion of pharmacovigilance, and participants’ evaluation of the educational programme. Materials and Methods A cross-sectional, post-session questionnaire-based study was conducted among healthcare students at Gyani Inder Singh Institute of Professional Studies, Dehradun, Uttarakhand. Participants attended a 2–3-hour structured pharmacovigilance programme comprising interactive lectures, audiovisual presentations, discussion, and instruction on ADR identification, reporting procedures, and the Pharmacovigilance Programme. Following the session, participants completed a faculty-reviewed, pilot-tested structured questionnaire. Because the study was designed to describe responses at a single post-session time point and did not include a pre-intervention or control group, categorical data were analysed descriptively as frequencies and percentages. Results A total of 61 students completed the survey. Most participants were enrolled in the Bachelor of Pharmacy programme (83.6%), while the remaining students represented Nursing, Diploma in Pharmacy, and Master of Pharmacy courses. Overall, 85.2% of students were familiar with the concept of pharmacovigilance, and 90.2% recognized the term adverse drug reaction. More than two-thirds (70.5%) reported having previously encountered an ADR during their academic or clinical exposure. Awareness regarding ADR reporting was observed in 78.7% of respondents, whereas 88.5% agreed that ADR reporting should be mandatory and that pharmacovigilance should receive greater emphasis within healthcare curricula. The educational programme was positively evaluated by participants, with the majority rating the session as either excellent or very good. Conclusion Healthcare students showed generally favourable post-session awareness and attitudes toward pharmacovigilance and ADR reporting, although gaps in reporting knowledge remained. The findings support continued pharmacovigilance teaching and practical ADR-reporting training; however, interpretation is limited by the single-centre convenience sample, predominance of B.Pharm participants, self-reported responses, and absence of pre–post assessment. Accordingly, the study indicates educational need and acceptability of the programme but does not establish a causal intervention effect.