Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. One aspect of the off-label problem in paediatrics depends on the lack of updating the drugs specific Summary Product Characteristics (SPC). This is a frequent problem in Italy. The Authors give the example of three of the most commonly prescribed drugs in paediatrics (acetaminophen, salbutamol and amoxicillin), the SPC which recommends wrong dosages compared to those based on the to-date evidence and recommended by clinical guidelines (“wrong-label”). Reviewing and updating of SPC should be one of the priorities to tackle the off-label problem in the Italian reality.
