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Younger Children with Respiratory Tract Infections Are More Exposed to Off-Label Treatments: An Exploratory
Greta Venckute1, Erika Zekaite-Vaisniene2, Urte Oniunaite3
1Department of Pediatrics, Medical Academy, Lithuanian University of Health Sciences, LT-44307 Kaunas, Lithuania.
Insights
Off-label drug use is common in pediatric emergency care, with nearly half of medications prescribed off-label. Younger children were more likely to receive these treatments, raising patient safety concerns.
Area of Science:
- Pediatric Emergency Medicine
- Pharmacology
- Patient Safety
Background:
- Off-label drug use is frequent in children.
- This practice poses significant patient safety risks.
- Limited data exists on factors influencing off-label prescribing in pediatric emergency settings.
Purpose of the Study:
- To investigate the prevalence and identify factors associated with off-label drug use.
- To analyze prescribing patterns in a pediatric emergency department (PED).
- To assess the safety implications of off-label prescribing in pediatric patients.
Main Methods:
- Retrospective data analysis of patients aged 0-18 years in a PED.
- Inclusion of patients diagnosed with respiratory tract infections for further analysis.
- Collection of demographic, clinical, and prescribing data; statistical analysis using SPSS.
Main Results:
- 47.5% of 387 prescribed medications were off-label.
- Off-label use was prevalent for otitis and bronchitis (p < 0.001).
- Younger children received off-label treatment more frequently (p < 0.001), with specific examples of incorrect administration and dosage.
Conclusions:
- Off-label and unlicensed drug prescribing is a significant issue in pediatric emergency care.
- Reliance on off-label prescribing raises concerns for patient safety and treatment compliance.
- Further research is needed due to limited clinical trials and therapeutic options for pediatric populations.
Abstract:
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 p < 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 (p < 0.001). There was incorrect administration of tobramycin with dexamethasone for otitis (n = 16, 100%) and inappropriate use of salbutamol inhalations by age (34.8%, n = 16). Some medications were given orally instead of injections (ondansetron n = 5, 62.5%; dexamethasone n = 82, 98.7%) or intranasally instead of intravenously (IV) (midazolam n = 7, 87.5%). IV adrenalin was prescribed for inhalations (n = 46). Younger children were more likely to receive off-label treatment (p < 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.
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