Abstract

OFF-LABEL USE OF MEDICINES AT A NEONATOLOGY CLINIC IN BULGARIA

*V. Pushkarova and V. Petkova

ABSTRACT

Newborn babies are a group of patients who require special attention with regard to drug therapy. The use of a drug in the paediatric population, with an insufficient knowledge of the pharmacokinetic and pharmacodynamic data, or of its side-effects, may result in undesirable effects, in the short- or long-term or both. However, many studies have demonstrated that some drugs used for hospitalized neonates as well as for those prescribed by general practitioners are either unlicensed or „„off-label‟‟. Although there are already legislative initiatives in the US and the EU to promote research into drug use in newborns, the percentage of off-label drugs in this group of patients remains high.

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