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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, refl ecting in scientifi c studies in USA and Europe. An important focus is on Romanian statistic of Sildenafi l prescription and on dilemmatic use of it in pediatric cardiology unit. [ABSTRACT FROM AUTHOR]

The paper presents the ethical and methodological issues of the scientific research in children. The ethic requirements for a scientific research are: its importance for health, scientific validity, subjects selection, favourable risk-benefit ratio, independent review, informed consent and respect for the enrolled subjects. Confidentiality is very important for subjects protection. The research Ethics Committees are the forum approveing the research. [ABSTRACT FROM AUTHOR]