New initiative to encourage more medicines for children
Paediatric joint venture leads the way
A joint venture for pharmacy paediatric research between the Institute
for Child Health, the London School of Pharmacy (SOP) and Great
Ormond Street has provided the impetus for another joint venture
at the SOP, this time in clinical pharmaceutics, with the pharmacy
department at University College London Hospitals NHS Trust. Kevin
Taylor, previously reader in pharmacy, has been appointed professor
of clinical pharmaceutics at SOP. |
Strategies to encourage pharmaceutical companies to develop better medicines for children were announced by the Department of Health and the Medicines and Healthcare products Regulatory Agency at the end of August. The initiative
is designed as a short- to medium-term measure, to complement the long-term
changes that will be brought in by the new European Union regulation
on paediatric medicines, the introduction of which has been delayed until
2006.
The UK initiative aims to increase the number of medicines labelled and
formulated for children. To do this, it will take advantage of the new
system for children’s medicines in the US and ask companies to
supply to it the paediatric data they submit to the US Food and Drug
Administration. It will also offer free scientific advice and waive fees
for applications that include paediatric safety information in the summary
of product characteristics. Other actions include encouraging companies
with paediatric medicines licensed outside the UK to apply for UK marketing
authorisations and to discourage the discontinuation of medicines used
in children.
Improving the amount of information available to prescribers, carers
and patients is the other main aim of the initiative. As part of this,
the DoH will provide funding for the production of the Children’s
BNF (BNF-C) and its distribution to pharmacists, doctors and extended
formulary nurse prescribers. BNF-C (published by the Royal Pharmaceutical
Society, the BMJ publishing group and the Royal College of Paediatrics
and Child Health publishing group) is expected to be launched next June,
with a new edition produced every year.
The MHRA is also working on ways to make patient information leaflets
more appropriate for medicines used to treat children.
Measures in the EU regulation to encourage the development of more medicines
for children include offering an extension of the supplementary protection
certificate if appropriate paediatric data is included in the summary
of product characteristics for patented products and a ten year period
of data exclusivity for off-patent products.
The UK strategy document and proposed EU regulation are available here
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Hospital Pharmacist