The Pharmaceutical Journal
Vol 268 No 7200 p763-765
1 June 2002

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  Control of entry
  ABPI
  Trade unions
  Electronic prescribing
  Unlicensed medicines
  APSGB
  Zimbabwe
  The Journal

Letters to the Editor

Unlicensed medicines

Is there a guidance leaflet for vaccines?

From Mr J. Burton, MRPharmS

I read with interest that the Standing Medical Advisory Committee (SMAC) has recommended the publication of a standard guidance leaflet explaining the issues surrounding the use of unlicensed medicines in children (PJ, 25 May, p711).

Along similar lines, my local nursing and medical colleagues and I find it difficult to explain the situation to patients who are receiving unlicensed vaccines before travelling abroad.

After looking into the various issues surrounding the use of unlicensed, named patient products such as Japanese encephalitis and tick-borne encephalitis vaccine, we came to the conclusion that we had a responsibility to inform patients of the unlicensed nature of the products. This can be quite tricky. Even if this rather complex situation is explained tactfully the absence of a full licence can still be confusing and worrying for patients, particularly in light of the adverse publicity surrounding MMR vaccination.

To date we have no experience of a patient refusing vaccination on the grounds of the unlicensed nature of a product. However, I would like to hear from anyone who is aware of a leaflet or some other kind of explanatory reference that can be given to patients to help them understand why certain vaccines (or any other product) are used when they do not have a licence.

Jonathan Burton
Stirling
e-mail pharmacist@thecampus pharmacy.com

Leaflet already available

From Mr A. J. Nunn, FRPharmS

The Standing Medical Advisory Committee (SMAC) should be aware that the standard leaflet it calls for (PJ, 25 May, p711) is already available and in use.

Leaflets for both carers and older children explaining the issues surrounding licensing of medicines for children were produced by the Joint Medicines Committee of the Royal College of Paediatrics and Child Health and the Neonatal and Paediatric Pharmacists Group in October 2000. They have been written at an appropriate reading age and reviewed by parent groups. Leaflets were distributed to all NHS trusts and the text is available from the websites of the two organisations (www.nppg.demon.co.uk [see Current Topics/Patient Information Leaflets] and www.rcpch.ac.uk [see Publications/Formulary]).

These information leaflets were also sent to the Royal Pharmaceutical Society for comment and for consideration for distribution to community pharmacists. The Society did not support the idea that the leaflets be made available for distribution direct to the public.

Tony Nunn
Director of Pharmacy,
Royal Liverpool Children's NHS Trust

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