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Abstract

PATTERN OF ADVERSE DRUG REACTION IN TEACHING CARE HOSPITAL IN SOUTHERN INDIA: A RETROSPECTIVE STUDY

Moulya MV*, Dinesh R and Nagesh Raju G

ABSTRACT

Adverse drug reactions (ADRs) are the major public health problem and are considered to be a leading cause of morbidity and mortality. A Retrospective study was performed by collecting data from 2010 to 2013. The aim of this study was to assess the incidence and pattern of ADRs, assess causality, severity and preventability of ADRs, and to classify the ADRs based on WHO Adverse Reaction Terminology (WHO-ART). For Severity assessment, Modified Hartwig scale was used. Naranjo causality algorithm was used for assessing causality. Modified Schumock and Thorntons Scale were used for identifying preventability of ADR. 95 % CI interval with alpha level of 0.05 was used to identify significance of difference. A total 209 ADRs were identified out of which 53 % were male and 47 % were female patients (P=0.08). Causality assessment scale indicates 71 % ADRs were possible, 23 % ADRs were probable related to drug (P<0.001). Severity assessment reveal that 78 % were mild, 20 % moderate and 2 % ADRs were severe (P<0.001). Preventability scale indicates that 93 % of the ADR were definitely preventable. Majority of the ADR (35 %) reported were belonging to gastrointestinal system according to WHO-ART, and most commonly reported ADR was vomiting. Although the ADRs in the present study were non serious and preventable, monitoring and management of such ADRs through therapeutic interventions would be beneficial in better patient care.

Keywords: Adverse drug reactions, WHO Adverse Reaction Terminology, Causality assessment.


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