A Study of Adverse Drug Reactions in a Tertiary care Hospital of Pune

Purpose: To study the adverse drug reactions (ADR’s) reported from wards and critical units in a tertiary care hospital of Pune. The adverse drug reactions were analyzed by Naranjo’s algorithm scale and Hartwig severity assessment scale and the outcomes were studied.Methods: This observational and cross-sectional study was conducted for 6months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital of Pune. The data collection was done only in wards and critical units. Patients of all age groups and either sex were included in this study. The adverse drug reactions were assessed for their causality and severity by performing the Naranjo’s algorithm scale and Hartwig’s scale respectively. The outcomes were studied. Data analysis was done by descriptive statistics. Result: Total 50 adverse drug reactions were reported from wards and critical units. 21-30 years age group was reported to have more adverse drug reactions. The most commonly affected organ is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%). According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite. As per Hartwig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20 (44.44%) and severe 4 (8.88%). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period.Limitations: Study was conducted only in wards and critical units not in all departments of the hospital. Some of the ADR’s have gone un-reported by Resident Medical Officer (RMO) due to increased work pressure, lack of awareness or busy environment.