Assessment, Monitoring and Reporting Adverse Drug Reactions of Corticosteroids: A Prospective Observational Study

Abstract

Background: Corticosteroids are widely used medication for the treatment of various conditions. Using too little dose of steroids can lead to sub therapeutic response whereas using higher dose of steroids can lead to Adverse drug Reactions (ADRs). These steroids, especially topical preparations are easily available in the pharmacy store and are sold without prescription. This has led to its irrational use and increased ADRs which has become a major concern. Aim: To assess, monitor and report suspected ADRs of Corticosteroid.

Method: A prospective observational study was conducted in the department of dermatology and general medicine in a tertiary care teaching hospital for the period of 6 months. All patients receiving any category of Steroid therapy were included. The suspected ADRs were assessed using standard scales and were reported to concerned departments. Result: A total of 226 patients were enrolled where 29 ADRs were detected. Around 3.98% of the subjects were found with clinically significant drug interaction. Oral steroids were responsible for most ADRs. Swelling of limbs was the most common ADR (3.09%) followed by joint pain (2.21%). On causality assessment, 31.06% of the ADRs were found to be Unlikely followed by 20.68% of the ADRS were certain via WHO scale whereas 41.4% were Doubtful and 20.68% were Definite via Naranjo scale. Most of the ADRs were probably preventable (72.42%) and moderately severe (62.08%).Conclusion: Involvement of pharmacist in patient care can help in prevention of ADRs which can promote drug safety and efficacy.

Keywords: ADR, Corticosteroids, Pharmacist, Pharmacovigilance