The Pharmaceutical Journal
Vol 270 No 7239 p334
8 March 2003

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Letters to the Editor

Children's medicines

A licence means a degree of confidence

From Mr C. Cheung, MRPharmS, and others

We are grateful for Professor Howard McNulty's opinions (PJ, 22 February, p269) regarding our Broad Spectrum article (PJ, 14 December 2002, p843). Unfortunately, the arguments he puts forward indicate he has misinterpreted our intentions and does not understand the issues faced by paediatric medical professionals.

We would like to reassure Professor McNulty that we are fully aware of the legal and ethical aspects of medicines utilisation. His letter summarises the Medicines Act 1968, but neglects to mention that the existence of marketing authorisation guarantees the quality, safety and effi-cacy of medicinal products. A manufactured "specials" product does not have to be assessed against this criterion.¹

The purpose of our article was to draw attention to the need for increasing the range of licensed paediatric medicines. Currently, the lack of reliable information and suitable formulations gives rise to potential drug errors.²

Using unlicensed medicines causes distress for all concerned. The use of unproven therapies requires a through understanding of the disease and the drug. Achieving this objective is perhaps easier in specialist centres (because of the concentration of knowledge and experience), but more difficult in the general setting of primary care. Furthermore, the outcome of an unlicensed product can be unpredictable; it may not have an effect, or may exacerbate the disease.

Unlicensed and off-label usage is acceptable for the interim period. However, if this were the norm for the long-term, then we, as health care professionals, are admitting children will never receive the best possible care. The assurance of a licence means there is a high degree of confidence that the therapy will work or, at the very least, cause no harm.

Professor McNulty is correct to state that pharmacists are the experts in medicines, but no one can predict the unknown, which is precisely the reason for reducing the need for unlicensed medicines.

Chi Cheung
John Persaud
Department of Pharmacy
Birmingham Children's Hospital NHS Trust

Seau-Tak Cheung
Department of Medicine
University Hospital Birmingham NHS Trust

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