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Unlicensed and off-label prescribing in children must improve

May 28, 2002

Many drugs prescribed to children in general practice are either not licensed for use in children ("unlicensed") or are prescribed outside the terms of the product licence ("off-label").

Three studies in this week's BMJ show that unlicensed and off-label prescription of drugs to children is common and carries a high risk of adverse drug reactions.

In the first study, researchers in Germany found 13% of prescriptions for a group of children in primary care were off-label. The proportion of off-label prescriptions was highest for 1-2 year olds and included drugs for heart conditions, genitourinary disorders, and anti-inflammatory agents. The authors conclude that efforts to improve the quality of drug treatment in children should not exclude widely marketed and firmly established drugs.

A second study by a team of Dutch researchers found over 22% of prescriptions for children aged 0-16 years were used off-label. Drug groups with the highest proportion of off-label use included oral contraceptives, and drugs for eye and skin conditions. They argue that many licensed drugs used by children in the community are poorly labelled for use in children, resulting in high rates of off-label use. Therefore labelling for children needs to be improved.

Although unlicensed and off-label prescribed drugs do not necessarily carry an actual threat to the health of a child, the risk of adverse drug reactions is high, as adequate dosing schemes have often not been assessed, according to a third study. The authors conclude that this situation is highly unsatisfactory, and efforts should be made to improve it.

British Medical Journal (BMJ)