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Italian Journal of Pediatrics

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Open Access 01-12-2014 | Research

Incidence of unlicensed and off-label prescription in children

Authors: Petra Langerová, Jiří Vrtal, Karel Urbánek

Published in: Italian Journal of Pediatrics | Issue 1/2014

Abstract

Background

Many common drugs have not been licensed for use in children.

Methods

This study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.

Results

Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.

Conclusions

This study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.

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Title: Incidence of unlicensed and off-label prescription in children
Authors: Petra Langerová
Jiří Vrtal
Karel Urbánek
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Italian Journal of Pediatrics / Issue 1/2014
Electronic ISSN: 1824-7288
DOI: https://doi.org/10.1186/1824-7288-40-12

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Incidence of unlicensed and off-label prescription in children

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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