A Prospective Observational Study on Causality and Severity Assessment of Adverse Drug Reactions in A Tertiary Care Teaching Hospital

Author(s): A V Kishore Babu* and A Srinivasa Rao

Abstract: Objective: Adverse drug reactions accounts for major hospital admission and relatively increased health care costs in the present days. The main purpose of the study is to assess the causality and severity of adverse drug reactions from various departments of tertiary care teaching hospital. Method: A prospective observational study was carried out in a tertiary care teaching hospital at Hyderabad, India, for a period of 12 months. Patients of all age and both genders were included in the study. Adverse drug reactions reported from various departments by physicians were analyzed by Naranjo’s and Hartwig’s Siegel’s scale respectively. Descriptive statistics were used for data analysis. Results: A total of 86 ADRs were reported over 12 month’s period. Of these, 57% in female and 43% in male category. Highest ADRs were reported from 21- 30 (31%) years of age followed by 31-40 (23%) years. Maximum numbers of cases were reported from general medicine department (37%). Among all the suspected drugs, antimicrobial agents accounted for 46% of total ADR cases. Most of the ADRs were involved on the skin (51%). Naranjo’s ADR probability scale showed that 55% of ADRs were probable. Hartwig’s and Siegel’s the severity assessment scales shown that 63% ADRs are moderate followed by 8% severe ADR cases. Conclusion: This study provides a database of ADRs due to commonly used drugs. Hence our study advises that there is a need of spontaneous ADR reporting from physicians. This study also suggests further research in India for the improvement of possible intervention strategies to reduce burden and cost of ADRs.

PAGES: 231-235  |  272 VIEWS  376 DOWNLOADS