Adverse drug reaction reporting practices and reasons for underreporting among healthcare professionals in a tertiary care hospital: a questionnaire-based study
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20261122Keywords:
Pharmacovigilance, Underreporting of ADRs, Adverse drug reaction reporting systems, Knowledge attitude practice, BarriersAbstract
Background: Adverse drug reactions (ADRs) are a major global public health issue. When severe it can lead to morbidity, mortality, hospital admissions, increased risk of readmission, longer hospital stays, and other negative outcomes. Unfortunately, underreporting is a major limitation of spontaneous notification systems, with only 6-10% of all ADRs reported, weakening pharmacovigilance and jeopardizes patient safety. This study was done to evaluate ADR-reporting practices and reasons for underreporting among healthcare professionals at a tertiary-care hospital.
Methods: A cross-sectional, questionnaire-based study was conducted using an online self-administered form circulated to all doctors and nurses at the study site. Data from 111 respondents were analysed. The questionnaire covered knowledge, attitudes and practices related to ADR reporting and perceived barriers to its reporting.
Results: Of 400 healthcare practitioners (HCPs) only 111 responded (27.75%). Among the 111 respondents; 77% knew the meaning of pharmacovigilance, 82% of respondents felt qualified to report ADRs, only 64.9% were aware of what to report, and even fewer (53.2%) knew how to report an ADR. Only 30 (27.0%) reported ever submitting an ADR report, while 81 (73.0%) had never reported. Among these non-reporters, the commonest barriers were lack of knowledge about the reporting procedure, uncertainty regarding causality, time constraints, and the perception that observed events were already known or not sufficiently serious to warrant reporting. Awareness of the institutional reporting mechanism and of national pharmacovigilance pathways was low.
Conclusions: Although awareness of pharmacovigilance was high, actual ADR reporting was low, hindered by unfamiliarity with processes, time constraints, and poor access to ADR reporting forms. Practical steps like hands-on training, simplified reporting, institutional support, and regular feedback are needed to convert positive attitudes into sustained reporting. Multicentre and longitudinal studies should evaluate these interventions.
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