title: [Off-label drugs use in children--clinical perspective].
abstract: Administration of drugs off-label occurs commonly in pediatrics. The majority of pediatricians prescribe unregistered drugs deliberately. The most common reasons that prompt them to do so are the necessity to treat their patients while there is no alternative medication, and their conviction that the treatment with an unregistered drug is more efficient and/or safer than the treatment with a registered one. The pediatric practice departs from the registered use of drugs most commonly in the following points: the dose, indications, different age of a patient. It is an alarming fact that a substantial group of medications used to treat children has not been included into clinical trials which might result in their registration as drugs suitable for use in pediatrics. Current legal regulations, which have been introduced mainly with the view of protecting patients' safety, considerably inhibit the implementation of clinical trials with children. Moreover, parents, guardians, as well as health-care providers often perceive medical experiments in a very negative way, which causes further difficulties. It should be stressed that the administration of drugs off-label is each pediatrician's autonomous decision for which they take full responsibility.
authors.affiliation: Klinika Chorób Dzieci Katedry Pediatrii, Polsko-Amerykański Instytut Pediatrii, Wydziału Lekarskiego, Uniwersytetu Jagiellońskiego w Krakowie. kwintap@mp.pl
authors.forename: Przemko
authors.initials: P
authors.lastname: Kwinta
mesh_terms: D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010372:Pediatrics / Q000592:standards*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012941:Social Responsibility