Opening Remarks

Studies in Europe (1) and Australia (2) have shown that a significant number of children, both in hospital and the community, receive unlicensed and off-label medicines. Unlicensed medicines are where the medicine has been modified from that specified in its product license (3). This may involve crushing a tablet in order to make it into a suspension so that a young child can take the medicine orally. Off-label medicines are those that are used in a different manner than recommended in the product license. This may involve using the medicine in a different age group, for a different indication, at a different dose or by a different route to that recommended (3)