A STUDY ON ADVERSE DRUG REACTIONS IN HOSPITALIZED PATIENTS WITH DIABETES MELLITUS IN A MULTI -SPECIALITY TEACHING HOSPITAL
Abstract
ABSTRACT
Objectives: Adverse drug reactions (ADRs) are well known to occur with any class of drugs when used in normal doses for the management of
diseases. Anti-diabetic agents are no exception to this. The main aim of the study was to detect and analyze ADRs in hospitalized patients with diabetes
mellitus in a multi-specialty hospital.
Methods: The prospective observational study was conducted in a 1000 bed multi-disciplinary teaching hospital at Dakshin Kannada district in south
India over a period of 2-year between June 2013 and May 2015.
Results: A total of 102 ADRs were reported from 99 patients during the study period with male predominance (60.60%) over females. The average
age of the patients in the study was found to be 59.8±13.15 years. The majority of the ADRs occurred in the age group of 40-80 years. The average
duration of diabetes mellitus in the study was 10.08±7.69 years. The class of drugs most commonly responsible for causing ADRs was found to be
anti-diabetic drugs (67.64%) followed by antimicrobial agents (10.78%). The most commonly occurred ADRs was hypoglycemia (63.72%) followed
by gastritis (6.86%). Causality assessment by using Naranjo scale indicated that majority of the ADRs (59.80%) were probable, 37.25% were possible,
and 2.94% were definite. The severity assessment using the Hartwig and Siegal scale indicated that the majority of the ADRs were mild†followed
by moderate†and severe,†respectively. Preventability assessment using modified Schumock and Thornton revealed that 57.84% were definitely
preventable, 33.33% were probably preventable, and 8.82% were not preventable.
Conclusion: The study shows that the active involvement of a clinical pharmacist helps in monitoring and detecting ARDs and their management
through therapeutic interventions would be beneficial in the better patient outcome.
Keywords: Adverse drug reaction, Diabetes mellitus, Clinical pharmacist.
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