Assessing Pharmacovigilance Knowledge, Attitudes, Practices and the Clinical spectrum of Adverse Drug Reactions among Healthcare Professionals at a Tertiary Care Teaching Hospital in Jaipur, India: A Two-Phase Observational Study
TL;DR
A wide gap separates ADR detection from ADR reporting in this setting and structured training embedded in medical and nursing curricula, simpler digital reporting channels, and targeted monitoring of high-risk drug classes such as antimicrobials and NSAIDs offer practical routes to narrow it.
Abstract
Background: Spontaneous reporting of adverse drug reactions (ADRs) by healthcare professionals (HCPs) remains the backbone of the Pharmacovigilance Programme of India (PvPI), yet persistent under reporting continues to limit the reliability of national drug safety data. Objectives: To assess the knowledge, attitudes, and practices (KAP) of HCPs regarding pharmacovigilance and ADR reporting, and to characterise the clinical spectrum, causality, severity, and preventability of ADRs documented at a tertiary care teaching hospital in Jaipur, Rajasthan. Materials and Methods: The study had two phases. Phase 1 was a cross-sectional online KAP survey of physicians and nurses (372 complete responses) using a 43-item pretested questionnaire. Phase 2 was a prospective, hospital-based observational study of 137 confirmed ADRs collected between February 2019 and May 2020 through combined active and spontaneous surveillance. Causality was assessed with both the WHO-UMC criteria and the Naranjo algorithm, severity with the Hartwig and Siegel scale, and preventability with the modified Schumock–Thornton criteria. Categorical associations were tested with the Chi-square test and expressed as crude odds ratios (ORs) with 95% confidence intervals (CIs). Results: Out of 372 respondents, 132 (35.48%) encountered the term pharmacovigilance for the first time through the survey itself. Although 260 (69.89%) had observed an ADR in practice, only 174 (46.77%) had ever filed a report. Previous use of the official reporting form (OR 8.34, 95% CI 4.05–17.18; p < 0.001) and formal pharmacovigilance training (OR 4.12, 95% CI 2.31–7.35; p < 0.001) showed the strongest associations with reporting. Among the 137 ADRs, antimicrobials (41.61%) and NSAIDs (27.74%) were the leading causative classes, and cutaneous reactions predominated. Half of the reactions (69/137, 50.36%) were judged definitely or probably preventable; 121 (88.32%) patients recovered completely and no deaths occurred. Conclusions: A wide gap separates ADR detection from ADR reporting in this setting. Structured training embedded in medical and nursing curricula, simpler digital reporting channels, and targeted monitoring of high-risk drug classes such as antimicrobials and NSAIDs offer practical routes to narrow it. Key words: Adverse drug reaction; India; knowledge attitude practice; pharmacovigilance; preventability; underreporting