title: Off-label use of drugs in children.
abstract: 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.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Frattarelli
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Galinkin
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Green
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Johnson
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Neville
authors.forename: Ian M
authors.initials: IM
authors.lastname: Paul
authors.forename: John N
authors.initials: JN
authors.lastname: Van Den Anker
mesh_terms: D002648:Child; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence* / Q000592:standards*; D010372:Pediatrics / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
keywords: adolescents; children; infants; off-label drug use; pediatrics; pharmaceuticals; prescribing