Off-label and unlicensed drug use among neonatal intensive care units in Southern Italy.

Background: Many drugs used for neonates are unlicensed or off-label. An increased risk of medication errors and unexpected adverse drug reactions is associated with their use. This risk is even higher in preterm newborns, because of their physiological immaturity and the exposure to many different medicines.

Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists.

Defining innovation in pharmacotherapy is complex because general definitions cannot be easily adapted to the specificity of different therapeutic areas. The Italian Society of Hospital Pharmacists has developed a position paper in which three criteria are used to recognise innovation to a new intervention: (1) clinical relevance of the trial's primary end-point; (2) evidence of superiority; (3) use of an adequate comparator in the controlled trial. Clinically relevant end-points should appear in predetermined lists by therapeutic area managed by our society; likewise, the third criterion must be documented by an authoritative therapeutic guideline recognised to be still valid.