THE ETHICS OF PRESCRIBING OFF-LABEL DRUGS IN CHILDREN. THE DILEMMA OF SILDENAFIL

Revista Romana de PEDIATRIE | Volumul LXIV, Nr. 2, An 2015

ISSN 1454-0398 | e-ISSN 2069-6175
ISSN-L 1454-0398
DOI: 10.37897/RJP

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Laszlo-Zoltan Sztankovszky, Magdalena Iorga, Cristian Gheonea and Georgiana Russu

ABSTRACT

The off-label prescription means that medicines are administered by an unlicensed route, in an unlicensed formulation or dosage or to a child below the stated age range. The use of drugs in an off-label or unlicensed manner to treat children is widespread. Because many prescribed treatments for children have not been adequately tested in children, this population of patients remains a vulnerable one. On the one hand, prescribing off-label use drugs in children determines a lot of controversies but, one the other hand, without this possibility, could be deprived of a chance to be treated. The paper presents the widespread phenomenon of off-label us drugs in children, reflecting in scientific studies in USA and Europe. An important focus is on Romanian statistic of Sildenafil prescription and on dilemmatic use of it in pediatric cardiology unit.

Keywords: ethics, drugs, children, prescribing, off-label

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