Off-Label Use of Drugs in Children

The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants,...

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Veröffentlicht in:Pediatrics (Evanston) 2014-03, Vol.133 (3), p.563-567
1. Verfasser: NEVILLE, Kathleen A
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description The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in the labeling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Practitioners use their professional judgment to determine these uses. As such, the term "off-label" does not imply an improper, illegal, contraindicated, or investigational use. Therapeutic decision-making must always rely on the best available evidence and the importance of the benefit for the individual patient.
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection
subjects Biological and medical sciences
Child
Children
Children & youth
Decision making
Drug therapy
Drugs
General aspects
Health aspects
Humans
Influence
Judgment
Medical sciences
Off label prescribing
Off-Label Use - legislation & jurisprudence
Off-Label Use - standards
Pediatrics
Pediatrics - legislation & jurisprudence
Pediatrics - methods
Pediatrics - standards
Prescription drugs
United States
United States Food and Drug Administration - legislation & jurisprudence
United States Food and Drug Administration - standards
title Off-Label Use of Drugs in Children
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