Younger Children are More Exposed to Off-label Treatment in Pediatric Emergency Department

Abstract

Background and Aims: off-label medication are prevalent in pediatrics and represents patient safety concern associated with elevated risk of adverse drug effects. We aimed to identify fac-tors linked to off-label drug use in our pediatric emergency department (PED). Methods: Retrospective data analysis was performed. All patients diagnosed with otitis or respiratory tract infections (RTIs)aged 0-18yrs who attended our PED September 1 st - October1st ;2022 were included. Data collected: gender, age, triage cathegory, chronic diseases, vital signs, PED-prescribed treatment(medications, dosages, administration methods). Statistical analysis was performed using SPSS 28.0, p < 0.05 was considered significant. Results: We analysed 473 patient records; median age- 3.595yrs(IQR1.97-5.77); 42.7%-female. Majority were triaged as 4 (not urgent)–85.6%. 17.1% had chronic diseases. 387 medications were prescribed, 47.5% were off-label. Mostly, off-label treatment was administered for unspecified external otitis (tobramycin & dexamethasone eye drops, n = 16 (100%)), acute laryngitis (adrenalin inhalations, dexamethasone orally), unspecified acute bronchitis (dexamethasone orally, salbutamol) (p < 0.001). 34.8% of salbutamol inhalations were misused by age (n = 16). Children received some medication orally vs injections (on dansetronn = 5, 62.5%; dexamethasone n = 82, 98.7%), intranasally vs IV(midazolam n = 7, 87.5%). IV adrenalin was always prescribed for inhalations (n = 46). There was no correlation between off-label prescription and gender, triage group, chronic diseases. We noted that younger children (3.4yrs (IQR1.9- 4.9) were more likely to receive off-label treatment (ORE - 0.17, CI95% (- 0.257-- 0.084);p < 0.001).Conclusions: We observed that leading cause of off-label use was inappropriate medication administration forms. External otitis, laryngitis, acute bronchitis were with highest prevalence of drug misuse. Younger children were more likely to receive off-label treatment in PED. Conclusions We observed that leading cause of off-label use was inappropriate medication administration forms. External otitis, laryngitis, acute bronchitis were with highest prevalence of drug misuse. Younger children were more likely to receive off-label treatment in PED.