The Pharmaceutical Journal
Vol 268 No 7199 p705-712
25 May 2002

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Call for children’s leaflet for unlicensed medicines

A standard leaflet explaining the issues surrounding medicines for children should be made available for pharmacists to include with children's medicines, the Standing Medical Advisory Committee (SMAC) has recommended.

In a recently updated document on licensing and prescribing of drugs in children, SMAC recommends that a generic information leaflet would help to reassure parents and children when a child receives a medicine that contains a leaflet stating that the drug is not recommended for children.

SMAC also recommends that one authoritative source of advice on non-licensed drugs in paediatrics, equivalent to the British National Formulary, should be produced. However, it concedes that a licensing body would be in a difficult position to sanction use of unlicensed medicines. SMAC suggests that a body such as the National Institute for Clinical Excellence might address the issue.

The recommendations, which also examine problems with research into paediatric drugs, are available here.

However, paediatric pharmacists say that the SMAC document adds little to what is already being done to correct the current situation.

Tony Nunn, director of pharmacy at the Royal Liverpool Children's NHS Trust, told The Journal that the information provided by SMAC was incomplete and often naive. No mention of DIAL, the national paediatric medicines advisory service at Alder Hey hospital, was made.

His views were endorsed by Sharon Conroy, chairman of the Neonatal Paediatrics Pharmacists Group. She added that the NPPG had worked hard to address the situation, including the production of "Medicines for Children", a national paediatric formulary, which seemed to have been ignored in the SMAC document.

The European Commission is also examining the issue of safety of children's medicines (PJ, 16 March, p349) and draft legislation will be published later this year.