Raspoloživost, efikasnost i kvalitet lekova u pedijatriji
Availability, quality and efficacy of drugs for use in pediatric patients
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This paper is focused on the most prominent problems of the contemporary pediatric pharmacotherapy: the lack of pediatrically designed and evaluated drugs, as well as the lack of pediatric formulations for children under 12 years of age. The availability of drugs that can be used in the treatment of children is significantly limited with the lack of pediatric formulations both for oral and parenteral use. Besides that, a majority of drugs that are used in the therapy of neonates and children's are not properly evaluated, so they are used off-label and unlicensed, which significantly influences efficacy and safety of a therapy. In addition, certain excipients that should be pharmacologically inactive can eventually cause severe adverse effects in neonates and infants. The dosing of drugs in formulations that can be used by children, based on results of pediatric clinical studies, is the utmost imperative of the contemporary pediatric pharmacotherapy.