Abstract

To determine the prevalence and the occurrence of ADR To determine the patients economic impact on ADRs treatment The study was carried out at South Indian tertiary care hospital, for a period of 6 months. All the necessary and relevant data were collected from patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview and reporter interview. Patients of either sex of any age who developed ADR within the hospital were included in the study. If any doubts/disagreements of the occurrence of ADRs (Allergic reactions due to pollen, dust and insect are excluded from the study).Patients who developed ADR outside of the hospital were excluded from the study. ADR documentation form was validated using CDSCO ADR form. Causality assessment was done using Naranjos assessment scale. Hartwig scale was used to analyze severity of ADRs. Among 22203 patients admitted to the hospitals during the 6 months period, a total of 32 suspected ADRs were reported and evaluated. The prevalence of ADR was found to be 0.14%, males were affected more, Type B reactions were more predominant, most ADRs reported were mild to moderate using Hartwig's scale most ADRs were found to be probable using Naranjos scale. Most of the ADRs were associated with Antibiotics (cephalosporins) prescribed from Hematology and Neurology department and mainly caused dermatological reactions. Patient economic expenditure was studied and most ADRs occurred during the disease treatment period (between the admission and discharge time). ADRs are a common occurrence, but are often not recognized. Even if they are recognized they are under-reported as many physicians are unaware that clinically important ADRs should be reported to ADRs monitoring centers.

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