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Improving children’s medicines
  1. I Choonara
  1. Correspondence to:
    Professor Imti Choonara
    Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby, UK; imti.choonara{at}nottingham.ac.uk

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Perspective on the paper by McLay et al (see page584)

It is reassuring that the majority of Scottish paediatricians are aware of the concept of off label prescribing (p XXX).1 The term off label relates to the use of a medicine in a manner different from that recommended by the manufacturers in their product licence.2 A formal classification system for the different types of off label and unlicensed drug use was described in 1997. In a period of a few years, several studies confirmed that off label drug prescribing was a significant problem in children in hospital,3 in neonates,4 and in primary care.5

The main reason for carrying out these epidemiological studies was to highlight the fact that medicines used in children have not been scientifically evaluated to the same extent as those used in adults.6,7 Groups such as the European Network for Drug Investigation in Children have highlighted that this is a problem in different European countries8 and subsequent studies have shown that it is a worldwide problem.9 Off label prescribing is associated …

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