Off-label drugs prescription in neonatology: a physician's duty or a medical hazardous attitude?

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.

Shared decision-making in neonatology: an utopia or an attainable goal?

Medical decision making is sometimes considered as a relatively simple process in which a decision may be made by the physician, by the patient, or by both patient and physician working together. There are three main models of decision making--paternalism, patient informed choice, and shared decision-making (SDM), having each one of these drawbacks and limitations. Historically, the most adopted one was the paternalism (strongly 'Doctor knows best'), where the professional made the decision based on what he/she considered to be as the patient's best interest, not necessarily contemplating patient's will and wishes.