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 language | Italian |
|---|---|
| Pages (from-to) | 364-372 |
| Number of pages | 9 |
| Journal | Giornale Italiano di Farmacia Clinica |
| Volume | 18 |
| Issue number | 4 |
| Publication status | Published - Oct 2004 |
Fingerprint
ASJC Scopus subject areas
- Pharmacology (medical)
Cite this
L'uso off-label dei farmaci per i bambini è una caratteristica comune nel nord del mondo. / Pandolfini, Chiara; Bonati, Maurizio.
In: Giornale Italiano di Farmacia Clinica, Vol. 18, No. 4, 10.2004, p. 364-372.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - L'uso off-label dei farmaci per i bambini è una caratteristica comune nel nord del mondo
AU - Pandolfini, Chiara
AU - Bonati, Maurizio
PY - 2004/10
Y1 - 2004/10
N2 - 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.
AB - 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.
KW - Drug labeling
KW - Drug prescriptions
KW - Legislation
KW - Pediatrics
UR - http://www.scopus.com/inward/record.url?scp=14744279319&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=14744279319&partnerID=8YFLogxK
M3 - Articolo
AN - SCOPUS:14744279319
VL - 18
SP - 364
EP - 372
JO - Giornale Italiano di Farmacia Clinica
JF - Giornale Italiano di Farmacia Clinica
SN - 1120-3749
IS - 4
ER -