The Pharmaceutical Journal
Vol 268 No 7200 p751-757
1 June 2002

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BMJ (bmj.com)

Off-label prescribing for children is common

Three studies published this week in the BMJ confirm that the unlicensed and off-label prescription of drugs to children is common (2002;324:1311, 1312 and 1313).

In the first study, German researchers found that among 1,592,006 prescriptions for a group of children in primary care, 13.2 per cent were off-label. The proportion of off-label prescriptions was highest for 1–2 year olds and was common for cardiovascular drugs, drugs used for genitourinary disorders and anti-inflammatory agents. The researchers conclude that efforts to improve the quality of drug treatment in children should also include widely marketed and firmly established drugs.

A second study, by Dutch researchers, found that 22.7 per cent of prescriptions for children aged 0 to 16 years were off-label. Oral contraceptives, eye, ear and skin products, and cardiovascular drugs were those most often used off-label.

In the final study, researchers, also from the Netherlands, calculated that the overall risk for children receiving an unlicensed or off-label drug was 13.9 per cent per consultation. They conclude: "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."