Open AccessTHE ETHICS OF PRESCRIBING OFF-LABEL DRUGS IN CHILDREN.THE DILEMMA OF SILDENAFIL
Author(s) -
Laszlo-Zoltan Sztankovszky,
Magdalena Iorga,
Cristian Gheonea,
Georgiana Russu
Publication year - 2015
Publication title -
romanian journal of pediatrics
Language(s) - English
Resource type - Journals
eISSN - 2069-6175
pISSN - 1454-0398
DOI - 10.37897/rjp.2015.2.4
Subject(s) - sildenafil , medicine , medical prescription , off label use , population , intensive care medicine , pediatrics , family medicine , pharmacology , environmental health
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.