Abstract
Adverse drug reaction (ADRs) monitoring is an ongoing and continuing process used by health care professionals to enhance effective patient care and to improve quality of life. The present study was carried out to monitor the incidence of ADRs in a multispecialty teaching hospital in India. A prospective reporting study was conducted including both in-patient and outpatient departments. The Naranjos Algorithm Scale was used for the casualty assessment and a Modified Hartwig and Siegel Scale was used for the severity assessment. Confirmed ADRs were classified according to the Wills & Brown method. The economic burden of ADRs was also measured by calculating the average cost incurred in treating the ADRs. During the study period, a total of 208 adverse drug events were reported, in which 183 reports from 172 patients were confirmed as ADRs. Out of 183 ADRs, 171 reactions were reported in in-patient departments and the remaining 12 from the outpatient department. Of all the ADRs, 132 (72.1%) reports during the hospital stay and 27.9% of ADR-related admissions were observed. The causality assessments of 92 cases were observed to be probable (50.3%). The severity assessment revealed that mild type (57.8%) reactions were most common. The majority of the reactions were of Type H (119, 65.0%), they were not predictable. In the management of ADRs, the suspected drug was discontinued in 61 (33.3%) cases. An ADR monitoring programme was found to be useful and beneficial to the patients and health care professionals for a better therapeutic outcome.
Published Version
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