Evaluation of prescribing pattern and adverse effects of fixed dose combination of non-steroidal anti-inflammatory drugs

Abstract

Background: The use of fixed does combination of drugs is a major controversial health related issue. The non-steroidal anti-inflammatory drugs (NSAIDs) is one of the most frequently use drugs in population. The present study was undertaken to observe the pattern of use fixed dose combinations of NSAIDs and its adverse effects. Methods: The study was approved by the institutional ethics committee. Randomly selected patients irrespective of age and sex, who were on NSAIDs from the indoor and outdoor patients of paediatric, medicine and orthopaedic departments, were included in the study. Patients with history of administration of NSAIDs in last 30 days kidney, liver, acid-peptic disease, pregnancy and lactation were excluded from the study. WHO causality assessment scale was used for adverse reactions occurred due to fixed dose combinations (FDCs) of NSAIDs. The preventability, severity of the adverse drug reactions (ADRs) was evaluated. Results: Total one thousand participants were included in the study, among them 112 had received analgesic FDCs. Diclofenac+paracetamol and ibuprofen+paracetamol were the highest used in the study. Maximum combinations were found in the age group 41-60 years, the second highest (37 combinations) were in age group of 19-40 years. Fourty-two ADRs were due to the use of FDCs of NSAIDS. It was found that nimesulide+paracetamol was culprit in causing ADRs in 60 percent and diclofenec+paracetamol was in 40 percent of the participants. GI related adverse reaction observed in 28 participants. It was found that eighty percent of the adverse reaction was possible in nature. Most of the ADRs were mild in nature. It was evident that majority of ADRs were definitely preventable. Conclusions: There is a wide use of analgesic FDCs which should be discouraged.