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Title: Effects of the Off-Label Drug Prescription in the Paediatric Population in Spain from the Adoption of the Latest European Regulation: A Pre-Post Study
Author: Lizano Díez, Irene
Aldalur-Uranga, Itziar
Figueiredo Escribá, Carlos de
Lastra, Cecilia
Mariño Hernández, Eduardo L.
Modamio Charles, Pilar
Keywords: Prescripció de medicaments
Seguretat dels pacients
Drug prescribing
Patients safety
Issue Date: 20-Apr-2021
Publisher: MDPI
Abstract: The year 2021 marks the 15th anniversary of the Paediatric Regulation (1901/2006/EC) in Europe. The main aim of the study was to conduct a pre-post comparison on the annual off-label prescription rates in the under-18 population in Spain and assess the potential influence of the Paediatric Regulation adoption. An observational study in the paediatric population was performed. Four cross-sectional annual periods, one before and the three latest periods after the adoption of the Regulation, were compared. Prescriptions in the primary health care setting were sorted by age group and drug and off-label status were determined. The number of off-label prescriptions issued by paediatricians was over two million per year. Prior to the adoption of the Paediatric Regulation, the off-label prescription rate was estimated at 7% of total prescriptions. Although the increase in the off-label rate over the study periods was mild, it was statistically significant (OR: 1.045; 95% CI: 1.043-1.046; p < 0.05). One of the most vulnerable population groups was neonates and infants up to 1 year, in which the off-label prescription rates showed the highest increase during the post follow-up period, which was statistically significant (OR: 4.270; 95% CI: 4.253-4.287; p < 0.05). The findings can help raise awareness and advocate for the development and authorization of medicines for children in the primary health care setting. Keywords: off-label prescription, paediatrics, paediatric regulation, pharmaceutical products, prescription drugs, primary health care
Note: Reproducció del document publicat a:‐tics13040588
It is part of: Pharmaceutics, 2021, vol. 13, num. 4, p. 588
Related resource:‐tics13040588
ISSN: 1999-4923
Appears in Collections:Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

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