A Prospective Study On Causality, Severity, Preventability & Predictability Assessment of Adverse Drug Reactions of Non-steroidal Anti-inflammatory Drugs With Drug Safety Monitoring

Abstract

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used medications for the treatment of pain and inflammation. Although NSAIDs are widely used in medical settings, they are not without adverse drug reactions (ADRs).

The purpose of this prospective observational study was to assess the incidence and pattern of adverse drug reactions, causality, severity, predictability and preventability of ADRs with NSAIDs in a tertiary care teaching hospital.

Method: A total of 600 Orthopaedic out-patients were enrolled in the study to assess the risk of ADRs caused by NSAIDs over a 10-month period. Naranjo’s Algorithm, modified Hartwig and Seigel scale and modified Schumock and Thornton scale were used to assess the causality, severity and preventability of the documented ADRs and descriptive statistics were applied.

Results: The 600 patients reported a total of 35 adverse events. The incidence of ADRs to NSAIDs was found to be 05.83%, with a total 10 types of ADRs. Tab Diclofenac (57.14%) was the most commonly prescribed NSAID associated with ADRs, followed by Paracetamol (11.42%) and others. The gastrointestinal system (71.43%) was the most commonly affected system organ class. The most frequently reported ADRs were gastritis (25.71%), nausea (17.14%) and abdominal pain (14.29%). According to Naranjo’s Algorithm, 62.87% of ADRs were possible and 37.14% were probable type, and the majority of ADRs were mild in severity. Among all the ADRs 71.43% were not-preventable, 20.00% probably-preventable, 08.57% definitely-preventable ADRs; while 91.43% ADRs were not-predictable.

Conclusion: In this study, the incidence of adverse reactions to NSAID was 05.83%, with Diclofenac being the most commonly implicated drug for ADRs. The majority of the suspected ADRs associated with NSAIDs were mild, possible, unpredictable and unpreventable. Management of such ADRs through therapeutic interventions would result in a better patient outcome.