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[Off-label pediatric medicines in Spain].
Roi Piñeiro Pérez1, Esmeralda Núñez Cuadros1, Belén Rodríguez Marrodán1
1Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), Madrid España.
Anales De Pediatria
|January 29, 2021
Summary
Off-label and unlicensed drug use in Spanish pediatrics is common, ranging from 10% to 90% of prescriptions. The Spanish Association of Pediatrics (CM-AEP) proposes actions to improve pediatric medication information, ensuring children
Area of Science:
- Pediatric Pharmacology
- Drug Regulation
- Evidence-Based Medicine
Background:
- Off-label and unlicensed drug use is prevalent in pediatric care, with prescription rates varying widely (10%-90%).
- Regulatory frameworks for such drug use have existed in Spain since 2009.
- Pediatricians' knowledge and adherence to regulations regarding these medications are often limited, with over half non-compliant, frequently due to lack of awareness.
Purpose of the Study:
- To address the challenges and variability in the use of off-label and unlicensed drugs in pediatric populations.
- To highlight the necessity and legality of using these medications in children.
- To propose improvements in drug information for pediatric use, as advocated by the Medicines Committee of the Spanish Association of Pediatrics (CM-AEP).
Main Methods:
- Analysis of existing regulations and common practices in Spain concerning off-label and unlicensed drug prescriptions in pediatrics.
- Review of factors contributing to variability in reported usage rates across different pediatric subspecialties and methodologies.
- Identification of knowledge gaps and compliance issues among pediatricians regarding drug legislation.
Main Results:
- Significant variability in the reported incidence of off-label and unlicensed drug use in children, attributed to methodological differences and subspecialty variations.
- Limited awareness and inconsistent compliance with drug regulations among a substantial portion of pediatricians.
- Confirmation that the use of off-label and unlicensed drugs, despite challenges, is both legal and essential in pediatric medicine.
Conclusions:
- There is a critical need to enhance the availability and accessibility of drug information tailored for the pediatric population.
- The Medicines Committee of the Spanish Association of Pediatrics (CM-AEP) is actively developing recommendations to improve pediatric pharmacotherapy.
- Ensuring optimal and safe medication use in children requires addressing regulatory knowledge gaps and improving drug information resources.
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