Smita Shenoy
Manipal University, India
Title: A retrospective analysis of serious adverse drug reactions in a tertiary care hospital
Biography
Biography: Smita Shenoy
Abstract
Serious adverse drug reactions (ADRs) are associated with morbidity and mortality and result in financial burden to the patient and society. A retrospective observational study of serious adverse drug reactions over 1 year in a tertiary care hospital was carried out. Risk factors for serious ADRs were identified (Chi square test). Average direct cost of managing the adverse drug reaction was calculated. Of the 985 adverse drug reactions reported, 95 were serious ADRs. About 49.47% (n= 47) of patients were males and 50.53% (n=48) were females. The mean age of patients with serious ADRs was 48.63±15.59 years. Of the total hospital admissions, 0.05% was due to serious ADRs. The median duration of hospital stay due to serious adverse drug reaction was 7(4, 11) days. Hematological disorders (41.05%) were the most common serious ADRs followed by electrolyte disturbances (18.94%) and hypersensitivity reactions (13.68%).The common serious ADRs were leucopenia (15.78%), febrile neutropenia (12.63%) and hyponatraemia (11.57%). Anticancer drugs constituted the majority of the suspect drugs. Concomitant medications included anticancer drugs, antitubercular drugs, antiretrovirals, antileprotic drugs, antimicrobials, steroids and analgesics. The risk factor for developing serious ADRs was gender (females, p<0.04 versus males), coexisting disease (p< 0.001) and more than two concomitant medications (p< 0.01). The average total direct cost was Rs. 7306.91 per serious ADR. Since ADRs are associated with a wide variety of drugs and can affect any organ in the body, it is important to detect them early and have appropriate preventive strategies.