Over the past 10 years, studies have shown widespread use of unlicensed and off-label drugs to treat children in hospital and in the community.1 2 A prospective European study showed that two thirds of children in hospital received at least one unlicensed or off-label drug, and almost half of all drug prescriptions for these children were either unlicensed or off label.1 Subsequent studies confirmed that the use of unlicensed and off-label drugs is more likely to be associated with drug toxicity.3

In 1999, concerns were raised about children in Europe receiving unlicensed or off-label drugs instead of ones that have been scientifically evaluated and licensed.4 In December 2006, after extensive consultation, the European parliament approved legislation that should improve the regulation of drug treatment for children (regulation number 1901/2006 on medicinal products for paediatric use).

The legislation aims to ensure that drugs used for children are subject to high quality …