PATTERN OF ADVERSE DRUG REACTIONS (ADRS) REPORTED TO THE PHARMACOVIGILANCE UNIT OF A TERTIARY CARE HOSPITAL IN NORTH INDIA
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Abstract
Adverse drug reactions represent a significant cause of morbidity and mortality in hospitalized patients. Pharmacovigilance systems are essential for detecting, assessing, and preventing drug-related adverse events in healthcare settings.
Objectives: To analyze the pattern of adverse drug reactions reported to the pharmacovigilance unit of a tertiary care teaching hospital in Mullana, Ambala, Haryana, and evaluate their characteristics, causality, and preventability.
Methodology: A retrospective observational study was conducted from November 1-25, 2018, analyzing ADR reports submitted to the institutional pharmacovigilance unit. Data collection included patient demographics, suspected drugs, ADR characteristics, causality assessment using WHO-UMC criteria, and preventability analysis using Schumock and Thornton scale. Statistical analysis was performed using SPSS version 25.0.
Results: A total of 156 ADR reports were analyzed, involving 142 patients. Mean age was 48.6±16.2 years with female predominance (54.5%). Skin and subcutaneous tissue disorders were most common (32.1%), followed by gastrointestinal disorders (24.4%). Antibiotics were the most frequently implicated drug class (28.8%), followed by NSAIDs (19.9%). Causality assessment revealed 'probable' relationship in 45.5% cases. Preventability analysis showed 38.5% ADRs were potentially preventable.
Conclusion: The study identified significant patterns in ADR reporting with predominance of dermatological reactions and antibiotic-associated adverse events. Implementation of targeted prevention strategies and enhanced pharmacovigilance activities are warranted to improve patient safety.
References
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Dr. Rajeev Ranjan Sinha
Assistant Professor, Department of Pharmacology, M M Institute of Medical Sciences and Research, Mullana, Ambala, Haryana, India
Dr. Firdous Hussain
Senior Resident, Department of Community Medicine, IGIMS, Patna, Bihar, India
Dr. Randhir Kumar
Assistant Professor, Department of Community Medicine, SGRRIM&HS, Dehradun, India
Dr.Arunkumar Rameshwarprasad Varun
Associate Professor, Department of Community Medicine, Rama Medical College Hospital & Research Centre, Hapur, Uttar Pradesh, India