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A prospective study of causality and severity assessment of adverse drug reactions of antibiotics at an Indian tertiary care teaching hospital

Volume No : (2021) Volume: 09 Issue : 42 Year : 2021 Page No: 33-36

Authors : Amit Kumar, V. N. Vamsi Krishna, U. Christine, M. Siva Ganga, G. K. Santosh Raju

Abstract :

Aim: The main aim of this study is to detect and evaluate the adverse drug reactions (ADRs) of antibiotics using causality and severity assessment scales. Materials and Methods: A prospective observational study was conducted for a period of 6 months. In this study, case reports of all the inpatients were included and outpatients were excluded. The causality assessment of reported ADR was carried out using World Health Organization Uppsala Monitoring Centre (WHO-UMC) system and Naranjo scale. Modified Hartwig-Siegel scale (MHS) was also used for the severity assessment of adverse events.

Results: A total of 106 ADR were reported from 143 patients. Among them, 60.4% were male and 39.6% were female. Majority of the ADR were found in the age group of 46–55 years

(40.6%). It was reported that azithromycin was the most frequent cause of ADR accounted for 23.6%, with vomiting, dysgeusia, erythema, and swelling. As per the WHO-UMC system, majority were observed with certain (56.6%) related adverse event and least was observed with conditional (1.9%). As per Naranjo scale, majority of the reports were comes under definite (58.5%) and least observed reports were comes under doubtful (4.7%). According to MHS scale, majority of the

reports were with moderate reactions (70.8%). Severe reactions were least observed in this study. 

Conclusion: Reviewing of medication history of antibiotics plays an important role in preventing adverse effects. Hence, clinical pharmacists should take the responsibility in providing evidence-based therapeutic recommendations for better management of adverse reactions.

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