What is it about?
This study evaluated the knowledge, attitude and practice (KAP) of doctors toward adverse drug reaction (ADR) reporting in a tertiary care teaching hospital in Sikkim. Using a structured questionnaire from the Pharmacovigilance Programme of India (PvPI), the study assessed how aware clinicians were about pharmacovigilance, how they perceived the importance of ADR reporting, and whether they actually engaged in reporting. Among 75 respondents, the overall knowledge score was moderate (56.3% correct responses). While almost all clinicians (97%) believed that ADR reporting is necessary, major gaps were found: 1. 79% were unaware that their hospital had an ADR Monitoring Centre (AMC). 2. 87% were not sending ADR forms to the AMC. 3. Only 24% had ever documented an ADR despite 75% encountering one in practice. Factors discouraging reporting included difficulty in assessing causality and lack of time
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Why is it important?
ADR reporting is the backbone of pharmacovigilance, enabling early detection of drug safety problems and safeguarding patients. India’s diverse population and disease patterns make local ADR data crucial, yet under-reporting weakens the national PvPI database. This study highlights a significant disconnect: clinicians generally recognize the importance of ADR reporting, but lack the knowledge, awareness, and systems support needed to translate that attitude into action. Identifying these barriers helps institutions design targeted interventions—such as training, sensitization, simpler reporting pathways, and improved communication—to strengthen drug safety surveillance in the region.
Perspectives
or clinicians: Understanding practical causality assessment tools (e.g., WHO–UMC scale, Naranjo algorithm) and being familiar with reporting processes can reduce hesitation and improve reporting rates. For hospital administrators: Strengthening visibility of the AMC, providing regular training, and simplifying the reporting workflow can transform ADR reporting into routine clinical practice. For policymakers and PvPI: The study underscores the need for sustained outreach, standardized training modules, and enhanced coordination between national, regional, and hospital-based pharmacovigilance units. For the public and patients: Improved ADR reporting leads to safer prescribing, better understanding of drug risks, and earlier identification of population-specific adverse effects.
Dr Supratim Datta
Sikkim Manipal Institute of Medical Sciences
Read the Original
This page is a summary of: An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim, Perspectives in Clinical Research, January 2015, Medknow,
DOI: 10.4103/2229-3485.167096.
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