L'uso off-label dei farmaci per i bambini è una caratteristica comune nel nord del mondo

Translated title of the contribution: The off-label use of drugs in children is a common aspect of prescribing throughout the world

Research output: Contribution to journalArticle

Abstract

The aim of this study was to evaluate the extent of, and compare the rates of, off-label drug use in pediatric therapies throughout the world in order to reveal which therapeutic areas are common to different countries and which areas are therefore important for effective interventions. A literature review was performed and 29 studies were evaluated, 11 of which involved pediatric hospital wards, 7 neonatal hospital wards, and 11 the community setting. In the pediatric hospital wards, off-label/unlicensed prescriptions ranged from 16-62%, in the neonatal wards they ranged from 55-80%, and in the community setting they ranged from 11-37%. The drugs most commonly involved in these prescriptions were acetaminophen, caffeine, salbutamol, and amoxicillin. The criteria used to classify prescriptions according to off-label or unlicensed status differed between studies, making a direct comparison difficult. Off-label prescribing exists everywhere and to a significant extent, but does not necessarily imply irrational prescribing. There is a lack of harmonization between the evidence, the product licenses, and clinical practice, and this is part of the reason off-label prescribing is so common. Many attempts have been made to improve knowledge on pediatric therapies, but more focused interventions are needed, also taking into consideration this lack of harmonization.

Original languageItalian
Pages (from-to)364-372
Number of pages9
JournalGiornale Italiano di Farmacia Clinica
Volume18
Issue number4
Publication statusPublished - Oct 2004

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Off-Label Use
Prescriptions
Pediatric Hospitals
Pharmaceutical Preparations
Pediatrics
Albuterol
Amoxicillin
Licensure
Acetaminophen
Caffeine
Therapeutics

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

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title = "L'uso off-label dei farmaci per i bambini {\`e} una caratteristica comune nel nord del mondo",
abstract = "The aim of this study was to evaluate the extent of, and compare the rates of, off-label drug use in pediatric therapies throughout the world in order to reveal which therapeutic areas are common to different countries and which areas are therefore important for effective interventions. A literature review was performed and 29 studies were evaluated, 11 of which involved pediatric hospital wards, 7 neonatal hospital wards, and 11 the community setting. In the pediatric hospital wards, off-label/unlicensed prescriptions ranged from 16-62{\%}, in the neonatal wards they ranged from 55-80{\%}, and in the community setting they ranged from 11-37{\%}. The drugs most commonly involved in these prescriptions were acetaminophen, caffeine, salbutamol, and amoxicillin. The criteria used to classify prescriptions according to off-label or unlicensed status differed between studies, making a direct comparison difficult. Off-label prescribing exists everywhere and to a significant extent, but does not necessarily imply irrational prescribing. There is a lack of harmonization between the evidence, the product licenses, and clinical practice, and this is part of the reason off-label prescribing is so common. Many attempts have been made to improve knowledge on pediatric therapies, but more focused interventions are needed, also taking into consideration this lack of harmonization.",
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