12 January 2000
Non-prescription drugs for kids
by Kate Melville
In what sounds like a complete impossibility it seems that children in Europe and possibly elsewhere are being denied the same rights as adults in relation to receiving treatment with drugs that have been fully tested.
At least this is the claim of a team of European researchers in a article in the British Medical Journal (BMJ).
In what may come as a shock to many parents it appears that many drugs are not tested in children and this means they are therefore not specifically licensed for use in children. Clinical trials of drugs are usually not performed on children, however drugs that are licensed are then often prescribed outside the terms of their product license.
Using drugs like this renders them "off-label". The result is considerable concern within Europe and the United States about the use of unlicensed and off label drugs in children, according to the research team that was led by Sharon Conroy from the University of Nottingham in conjunction with colleagues from Sweden, Germany, Italy and the Netherlands.
Conroy's team investigated the prescribing practices in the children's wards of five hospitals in Derby, Uppsala, Marburg, Bergamo and Rotterdam.
Their results showed that over four weeks in 1998, 2,262 drug prescriptions were administered to 624 children. Almost half of all the prescriptions were either unlicensed or off-label (872 were off-label and 164 were unlicensed). This led to more than two thirds receiving an unlicensed or off-label prescription during their stay in hospital. From this small study it's not hard to see that there seems to be a real problem with the use of off-label and or unlicensed drugs to treat children.
If this issue is as wide spread as the study indicates then either the regulations for drug licensing will need to be altered or the way such drugs are used will need to be more carefully monitored.