Raspoloživost, efikasnost i kvalitet lekova u pedijatriji

Abstract

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.

Ovaj rad je fokusiran na najznačajnije probleme savremene farmakoterapije u pedijatriji: nedostatak pedijatrijski dizajniranih i evaluiranih lekova, kao i nedostatak pedijatrijskih formulacija za decu mlađu od 12 godina. Dostupnost lekova koji se mogu koristiti u terapiji dece značajno je ograničena nedostatkom pedijatrijskih formulacija kako za oralnu tako i za parenteralnu primenu. Osim toga, veliki broj lekova koji se svakodnevno koristi u terapiji novorođene dece nije propisno evaluiran i upotrebljava se najčešće mimo propisane licence, što značajno utiče na efikasnost i bezbednost terapije. Osim toga, pojedine pomoćne supstance, koje u principu treba da budu farmakološki neaktivna jedinjenja, mogu izazvati ozbiljne neželjene efekte kod novorođenčadi i odojčadi. Doziranje lekova u formulacijama koje mogu da koriste deca, zasnovano na rezultatima pedijatrijskih kliničkih studija, imperativ je savremene farmakoterapije dece.