A retrospective cross-sectional study to analyze adverse drug reactions reported at tertiary care hospital

Objectives: To analyze the pattern and nature of adverse drug reactions (ADRs) reported to ADR monitoring center (AMC) of tertiary care hospital in Kanpur. Materials and Methods: This study is a retrospective crosssectional analysis of all ADRs reported to AMC, Department of Pharmacology, GSVM Medical College, Kanpur during 12 months duration (July 2018 to June 2019). These ADRs were analyzed for the pattern, system organ class involved, suspected drug/drugs, type of reactions, seriousness and causality assessment. Results: A total of 408 ADRs were reported from 299 patients. The majority of the patients (84.950%) were between 19-60 years with female preponderance (54.515%). As per the WHO-UMC causality assessment system, 84.615% ADRs were probable while 15.385% ADRs were possible and 3 patients (1.003%) suffered from serious ADRs. The gastrointestinal (36.520%) was the most affected system, followed by the nervous system (15.931%), skin & subcutaneous tissue (14.706%), psychiatric (13.971%) and general (10.539%) disorders. The majority of ADRs were of type-A (86.275%) while remaining of type-B (0.490%), type-C (0.490%) and type-F (0.245%). Conclusions: We can prevent these ‘avoidable’ reactions by safe prescribing and enthusiastic participation in pharmacovigilance. The concept of ADR reporting is still new in India and reporting of ADRs is scarce. There is a need for active participation of all the departments of this tertiary care hospital for ADRs reporting. This study warrants further research in the northern part of India for the development of possible intervention strategies so that the burden of ADRs can be reduced.