title: Off-label drugs prescription in neonatology: a physician's duty or a medical hazardous attitude?
abstract: The off-label and unlicensed use of drugs in neonatology is a widespread reality in all the NICUs. Several explanations may be given to justify the extension of this phenomenon and, among them, the lack of ad hoc clinical trials in neonatal subpopulation and the freedom to cure worldwide recognized to relatives and physicians. It is well known that adverse effects are more frequent, more serious and more underreported when medicines are used unauthorized or off-label, being physicians in theory responsible for the newborn physical damage. To avoid this responsibility, we believe that a shared legal framework may be helpful where the informative process on risks/benefits ratio for the newborn has a pivotal role. The National and International Scientific Societies should promote a common guidelines also for the informations on drug effects to be supplied to relatives. But at the same time EMA has to implement its strong policy towards the mandatory request on trials, for every new drug, on specific neonatal and pediatric subpopulations.
authors.affiliation: Forensic Science Department, Cagliari University, SS 554 bivio Sestu, Monserrato (CA), Italy. ernestodaloja@pacs.unica.it
authors.forename: Ernesto
authors.initials: E
authors.lastname: d'Aloja
authors.forename: Francesco
authors.initials: F
authors.lastname: Paribello
authors.forename: Roberto
authors.initials: R
authors.lastname: Demontis
authors.forename: Mima
authors.initials: M
authors.lastname: Müller
mesh_terms: D001291:Attitude of Health Personnel; D005610:Freedom; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal / Q000941:ethics / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D008318:Malpractice / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D028681:Moral Obligations; D009359:Neonatology / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D010820:Physicians; D010818:Practice Patterns, Physicians' / Q000941:ethics / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data