Journal of Clinical and Diagnostic Research (Feb 2012)

ADR Monitoring of NSAIDs among the in-Patients of the Orthopaedic Ward in a Tertiary Care Centre: A Prospective Observational Study


Journal volume & issue
Vol. 6, no. 1
pp. 42 – 46


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Background: The non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used of all the drugs. Despite their wide clinical use, their gastro-intestinal toxicity is a major limitation. A number of studies describe NASIDs as the leading causes of adverse drug reactions (ADRs). To augment an adverse drug reaction monitoring system, an active surveillance was planned and a pilot study was started in a tertiary care teaching hospital in Chennai. Objectives: The main aim of this study was to identify the incidence of the ADRs of the NSAIDs among the in - patients of the orthopaedic ward. It also aimed to assess the causality and the severity of the adverse effects with the monitoring of rational prescribing. Materials and Methods: This prospective, observational study was conducted among 200 in-patients of the orthopaedic ward over a period of 6 months. The incidences of the ADRs were collected and analyzed. The causality was analyzed by using Naranjo’s Algorithm and the severity was analyzed by using the Hartwing and Siegel scale. Result: Totally, 200 in- patients were studied, among which 5.5% (n=11) reported the occurrence of ADRs. Nearly 63.64% (n=7) of the ADRs were reported by men and 36.36% (n=4) were reported by females. The reactions which were observed were nausea, vomiting, gastritis, abdominal pain, diarrhoea, headache, rashes and oliguria. The most commonly reported ADR was gastritis and the system which was involved was the gastro-intestinal system. With the given drugs, Tablet (Tab) Diclofenac accounted for 72.73% (n=7) and Tab.Ibuprofen for 27.27 %( n=3) of all the ADRs. As per Naranjo’s Algorithm, 63.63% of the adverse reactions were “possible” and 36.37% were “Probable”. The severity assessment showed that 72.73% of the adverse effects were mild and that 27.27% were moderate. Conclusion: The incidence rate of the ADRs in the orthopaedic ward was found to be 5.5% and the ADRs were mild in nature. This shows that rational drug therapy and better prescription practices had brought down the ADRs to minimal in our tertiary care teaching hospital in Chennai.