Vol. 2, Issue 1, Part A (2025)

Background: Pharmacovigilance (PV) plays a pivotal role in ensuring medication safety through the detection and reporting of adverse drug reactions (ADRs). Hospital pharmacists, being central to medication management, are uniquely positioned to identify and report ADRs. However, under-reporting remains a global issue, particularly in developing countries.

Objective: This study aimed to assess the awareness, attitudes, and reporting practices regarding pharmacovigilance among hospital pharmacists across India and to identify factors influencing ADR-reporting behavior.

Methods: A nationwide, cross-sectional, questionnaire-based survey was conducted among 620 hospital pharmacists working in tertiary, secondary, and private hospitals. Data were collected through a validated, self-administered questionnaire covering four domains: demographic characteristics, knowledge, attitudes, and ADR-reporting practices. Descriptive statistics summarized participant responses, while chi-square tests and logistic regression identified predictors of ADR reporting. Statistical significance was set at p<0.05.

Results: Of the 780 distributed questionnaires, 620 complete responses were analyzed (response rate: 82.3%). The mean PV knowledge score was 6.8±1.9, with 57.4% demonstrating adequate knowledge. Although 86.1% recognized ADR reporting as a professional duty, only 27.9% had ever submitted a report, and just 11.6% had reported in the past year. Major barriers included uncertainty about causality (52.3%), lack of knowledge on reporting procedures (47.4%), and workload constraints (43.1%). Prior PV training (AOR 2.48, 95% CI 1.72-3.56, p<0.001), working in tertiary-care hospitals (AOR 1.64, p = 0.013), and ≥5 years of experience (AOR 1.39, p = 0.021) were significantly associated with ADR reporting.

Conclusion: Despite favorable attitudes and moderate knowledge, ADR under-reporting among hospital pharmacists remains a challenge. Strengthening pharmacovigilance requires multifaceted strategies, including routine PV education in pharmacy curricula, periodic training workshops, hospital-based PV committees, integration of electronic reporting systems, and feedback mechanisms. Enhancing institutional support and creating a non-punitive, feedback-driven reporting culture are critical for improving participation and ensuring medication safety at the national level.