Adverse drug reactions evaluation of antimicrobials in COVID-19 inpatients using Modified Trigger Tool and Naranjo Algorithm

Background: The use of antimicrobials in COVID-19 treatment might increase the risk of adverse drug reactions (ADR). Therefore, the adverse effect further identification was needed to understand the safety profile of using these medicines. Objective: The research aims to evaluate the adverse effects of the use of COVID-19 antimicrobial agents, causality analysis, and factors related to this ADR. Method: Cross-sectional study using random sampling was conducted to obtain the data. The study used samples from COVID-19 adult inpatients in a hospital located in Java from July-December 2020. Adverse events (AE) were detected by a modified trigger tool using medication and laboratory result module triggers with 21 total triggers. Causality analysis of ADR was conducted using Naranjo Scale. Result: Of the 107 patients examined in this study, 92 patients had triggers. A total of 274 adverse events were found, where 265 adverse events were detected using the trigger tool, and 9 adverse events were detected without the trigger tool. The results of the ADR analysis using the Naranjo algorithm were obtained from as many as 126 ADRs in 60 patients with possible (94.4%) and probable (5.6%) scoring. The most common antimicrobials that cause ADR were azithromycin and oseltamivir. The most effective trigger in detecting ADR was the use of sedation with a positive predictive value of 0.67. The statistical analysis results showed no relationship between gender, age, comorbidities, severity, and body mass index on the incidence of ADR (p>0.05). Conclusion: Adverse drug reactions were commonly found in the use of azithromycin and oseltamivir for COVID-19 patients, so it is necessary to consider the choice of this therapy. The trigger tool and Naranjo algorithm were adequate to help the ADR monitoring process.