Assessment of analgesics induced adverse drug reactions in a tertiary care Hospital

Abstract

The objective of the study was to ascertain the different type of adverse drug reactions associated with analgesics, used for treating pain associated with different ailments in a tertiary care hospital and determine their causal relationship with the offending drug. This observational, non-interventional study was conducted in a tertiary care hospital at GSVM medical college Kanpur (U.P), India. Adverse drug reactions were reported by the physicians of different department and ADRs were assessed for different parameters-causality assessments, outcome and seriousness of ADRs as per World health organization (WHO), Expanded Rawlins and Thompson’s classification scale was used for determining type of ADRs, Predictability using CIOMS guidelines, severity using modified Hartwig’s scale and preventability as per Schumock and Thornton criteria. A total of 192 adverse drug reactions were reported from analgesics during treatment in tertiary care hospital. The Burden of ADRs in each patient was 2.25. Most of the adverse drug reactions were observed in the age group of 40-60 year. Gastritis (22.4%) was commonly reported reaction. Among analgesics, Aceclofenac + Paracetamol leads to 10.94% ADRs followed by Piroxicam (10.43%). Most of the adverse drug reactions on causality assessment were of Probable (96.35%) and possible (3.65%) nature. Type -A ADRs account for more than 50% of the total reported ADRs, followed by Type-B, C and D. Severity of most ADRs was found to be mild (94.80%) followed by severe and moderate and serious ADRs account in 4.69% cases and among serious ADRs most common were hematemesis (33.33%) and rash (22.22%). Most of the ADRs were of not-predictable type (69.27%) and not preventable type (96.34%). Digestive system was the most common organ system associated with Analgesics -ADRs.