Prescribing of drugs to children either without a suitable licence or off-label is a Europe-wide problem that requires European action, say Mrs Sharon Conroy (academic division of child health, University of Nottingham) and colleagues. Unless European agencies become more proactive in getting drugs tested in children, these patients "will continue to be denied the same rights as adults in relation to receiving treatment with drugs that have been fully tested", they add.
Reporting in the British Medical Journal (2000;320:79) Mrs Conroy et al describe a prospective study of drugs administered to children in general paediatric medical wards over four weeks. The aim of the study was to determine the extent of unlicensed and off-label drug use in five countries within the European Union. A total of 624 children received 2,262 prescriptions during the study period. The authors found that almost half of these prescriptions (1,036) were either unlicensed or off-label and over two-thirds of the children (67 per cent) received such a prescription. Many more prescriptions were off-label (872) than unlicensed (164) and analgesics and bronchodilators were among the top five off-label drugs prescribed in four of the five centres. More than half of off-label drug use in three of the centres was changes to dose and frequency, and this accounted for a third of off-label use in the other two centres, the authors say. Other common off-label uses were administration of a different formulation or in an age group for whom the drug had not been licensed. The authors suggest that the widespread use of inhaled corticosteroids in children aged under two years is a particular problem, as there are few data on growth suppression caused by therapy in this age group.

Children are being denied the right to fully tested drugs, the authors say