Younger Children with Respiratory Tract Infections Are More Exposed to Off-Label Treatments: An Exploratory Retrospective Study in a Pediatric Emergency Setting.

UNLABELLED

Off-label drug use is prevalent in the pediatric population and represents a patient safety concern. We aimed to identify factors for off-label drug use in our pediatric emergency department (PED).

METHODS

We performed a retrospective data analysis. All patients aged 0-18 referred to PED from 1 September to 1 October 2022, were included. Further analysis was performed when respiratory tract infections were diagnosed.

DATA COLLECTED

gender, age, triage group, chronic diseases, vital signs, and PED-prescribed treatment (medications, dosages, methods of administration). Statistical analysis used SPSS 28.0, with significance at < 0.05.

RESULTS

Data from 473 patients were analyzed, median age 3.5 years. Chronic diseases were present in 17.1% of children. 387 medications were prescribed, 47.5% being off-label. Off-label treatment was common for external otitis, acute laryngitis, and acute bronchitis ( < 0.001). There was incorrect administration of tobramycin with dexamethasone for otitis ( = 16, 100%) and inappropriate use of salbutamol inhalations by age (34.8%, = 16). Some medications were given orally instead of injections (ondansetron = 5, 62.5%; dexamethasone = 82, 98.7%) or intranasally instead of intravenously (IV) (midazolam = 7, 87.5%). IV adrenalin was prescribed for inhalations ( = 46). Younger children were more likely to receive off-label treatment ( < 0.001).

CONCLUSION

Our study highlights the widespread issue of off-label and unlicensed drug prescribing in pediatric emergency care. Further research is necessary, because this reliance on off-label prescribing raises concerns about patient safety and compliance, especially given the limited clinical trials and therapeutic options available.