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[Drug prescriptions study in the outpatient setting: assessment of off-label uses in children]
Encarnación Blanco-Reina1, M Auxiliadora Vega-Jiménez2, Ricardo Ocaña-Riola3
1Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España.
Insights
Nearly one-third of pediatric outpatients receive off-label or unlicensed prescriptions, often due to age or dosage variations. Improving evidence-based medicine is crucial for safer pediatric drug therapy.
Area of Science:
- Pediatric Pharmacology
- Drug Utilization Studies
- Evidence-Based Medicine
Background:
- Pediatric patients often receive medications prescribed off-label or unlicensed due to limited approved drug information.
- Understanding prescription patterns is essential for ensuring safe and effective medication use in children.
Purpose of the Study:
- To evaluate the prescription profile of non-hospitalized pediatric patients.
- To assess the prevalence and reasons for off-label and unlicensed medicine use in this population.
Main Methods:
- Cross-sectional study conducted in pediatric units and an emergency room.
- Data collected included sociodemographics, reasons for consultation, and therapeutic medication information.
- Prescriptions were classified based on Summary of Product Characteristics (SPC) requirements.
Main Results:
- 388 children were included, with an average of 1.7 drugs per child.
- Most prescribed drugs included ibuprofen, paracetamol, amoxicillin-clavulanate, and budesonide.
- 27.4% of prescriptions were off-label, primarily due to different age (60%) or dose (21.5%).
Conclusions:
- A significant proportion of pediatric outpatients are exposed to off-label or unlicensed prescriptions.
- Off-label use is often based on limited official information, highlighting the need for more research.
- Encouraging evidence-based medicine and adherence to specific drug regulations is vital for improving pediatric pharmacotherapy.
Objective:
to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric patients.
Design:
cross-sectional study.
Setting:
pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga).
Main Measurements:
sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC).
Results:
A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group. 27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10).
Conclusions:
The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations.
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