DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20183933

Evaluation the pattern of adverse drug reactions by non-steroidal anti-inflammatory drugs at the outpatient orthopedics department of a university teaching hospital in north India

Harpreet Singh Sidhu, Akshay Sadhotra

Abstract


Background: The study was conducted with an aim to evaluate the pattern of occurrence of adverse drug reactions (ADRs) of Non-steroidal anti-inflammatory drugs (NSAIDs) in orthopedic patients in a tertiary care teaching hospital of North India.

Methods: An observational study was carried out in the orthopedic outpatient department at the tertiary care hospital for the period of six months. All patients diagnosed with acute pain and receiving NSAIDs were included. The documented ADRs were assessed for causality, severity and preventability using Naranjo’s algorithm and WHO-UMC scale, modified Hartwig and Seigel Scale and modified Schumock and Thornton scale, respectively.

Results: A total of 84 ADRs were reported from 51 patients. The most common ADRs observed were from gastrointestinal (38%) followed by skin (18%) and autonomic nervous system (12%). Maximum number of ADRs were reported in patients on diclofenac (47%) followed by piroxicam (44%). Upon causality assessment, majority of the reactions were possible (61.5% with WHO-UMC scale, and 57.1% with Naranjo’s algorithm). The association of results between the two scales was statistically significant (p<0.001). Majority of ADRs (73.4%) were assessed as mild and 66.7% of the ADRs were probably preventable.

Conclusions: Authors conclude that incidence of ADRs can be decreased and compliance can be improved by early detection and management.

Keywords


Adverse drug reactions, Fixed dose combination, India, Pharmacovigilance

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