A Profile of Adverse Drug Reactions in a Teritiary Care Teaching Hospital and Associated Factors

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Objective: The present study was conducted to identify, analyze the causality, and severity of adverse drug reactions and to find out the factors associated with ADR related factors. Adverse effects of drugs are identified as one of the main reason for increasing in-patient number in the hospital. This has become financial burden and also rise in mortality rate in society. The main purpose of the pharmacovigilance program is to identify the risks linked with the use of drugs. This study may be useful to identify and prevent adverse effects caused by drugs to increase the quality of life and ability of doctors to treat consequences of ADRs more effectively. The main aim of the present study was to explore and identify adverse effects caused by drugs and to improve patient safety with pharmacovigilance activities. Method: An observational study was conducted as part of Pharmacovigilance program for 14 months (January 2018 - Feb 2019). ADRs reported from hospital were filled into Suspected ADR forms - CDSCO forms. Causality assessment was done based on WHO- UMC causality scale and severity was assessed using Hartwig-Siegel scale. By taking history of the patient, and by regular monitoring of the inpatients, the causative factors for ADR related hospital admissions were evaluated. Results: Total 145 ADR reports were analyzed. Most of the ADRs were observed in females (60%). Majority of ADRs were caused by NSAIDs (32.4%), followed by antimicrobials (20%). Most common organ systems involved was skin (38%). Causality assessment showed 85.5% ADRs as probable. 18.6% of ADRs were of severe type and 51% moderate. ADR related hospital admissions were found in 53 cases (36.5%) and 92 cases of ADRs occurred during hospitalization (63.4%). Conclusion: The study generated a data of ADRs that is useful to the clinicians for optimum and safe use of drugs in day to day practice and help in creating ‘P’ drug list. The major reasons for ADR related hospital admissions are OTC and non-compliance. Hence a constructive Pharmacovigilance to minimize ADR related hospitalization, treatment cost, morbidity and mortalities are the need of the hour.