Unapproved and Off-Label Use of Drugs in a Children's Hospital

To the Editor: Treatment of children may be difficult because of a shortage of properly formulated or approved drugs. 1 In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). W...

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Veröffentlicht in:The New England journal of medicine 2000-10, Vol.343 (15), p.1125-1125
Hauptverfasser: `t Jong, Geert W, Vulto, Arnold G, de Hoog, Matthijs, Schimmel, Kirsten J.M, Tibboel, Dick, van den Anker, John N
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container_end_page 1125
container_issue 15
container_start_page 1125
container_title The New England journal of medicine
container_volume 343
creator `t Jong, Geert W
Vulto, Arnold G
de Hoog, Matthijs
Schimmel, Kirsten J.M
Tibboel, Dick
van den Anker, John N
description To the Editor: Treatment of children may be difficult because of a shortage of properly formulated or approved drugs. 1 In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). We studied the unapproved and off-label use of drugs in a children's hospital in which the hospital pharmacy, unlike pharmacies in many other European countries, is allowed to prepare “homemade” formulations and to modify commercial preparations in order to suit the needs of children. During a five-week period, we classified the use . . .
doi_str_mv 10.1056/NEJM200010123431515
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine
subjects Adolescent
Child
Child, Preschool
Drug Approval
Drug Labeling
Drug Prescriptions - statistics & numerical data
Drug Utilization Review
Formularies, Hospital
Hospitals, Pediatric - statistics & numerical data
Humans
Infant
Infant, Newborn
Netherlands
title Unapproved and Off-Label Use of Drugs in a Children's Hospital
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