Children's medicines strategy launched by DoH
Promotion of research into paediatric medicines and the provision of better information on the use of medicines in children form part of a new paediatric medicines strategy launched earlier this week by the Department of Health. The strategy has been developed now because planned
changes to the regulatory structure at a European level, also designed
to improve medicines use in children, will not be adopted before 2006.
The UK strategy aims to increase the number of medicines that are appropriately
labelled and formulated for children. To do this, the Medicines and Healthcare
products Regulatory Agency has requested that manufacturers
provide data from trials involving children that have already been submitted elsewhere
(PJ, 29 May, p664). The MHRA will also offer free advice and fee waivers
for applications to include paediatric safety data in summaries of product
characteristics. Furthermore, the agency will advise companies on product
development where there is a therapeutic need for a paediatric version
of a medicine.
Other steps being taken are to discourage the discontinuation of paediatric
formulations of medicines and to invite companies that have licences
for children’s medicines in other countries to apply for a UK licence.
The other main strand of the new strategy is to improve information provision
around children’s medicines. As part of this, the DoH will provide
funding for the publication of the Children’s BNF (BNF-C) and its
distribution to pharmacists, doctors and extended formulary nurse prescribers.
BNF-C (jointly produced by the British Medical Association and the Royal
Pharmaceutical Society) is expected to be launched in June 2005 with
a new edition produced every year.
Ian Costello, editor of the BNF-C said: “Health care professionals
need clear, reliable and up-to-date information to inform prescribing
decisions. The BNF for children is a crucial step towards helping them
make the best decisions for their younger patients.”
The MHRA is also working on ways to make patient information leaflets
more applicable to the use of medicines in children. At present, leaflets
can be confusing when a medicine is being used off-label.
The strategy document is available as a PDF file
(120K).
ESRC/MRC funding An initiative set up between the Institute
of Education and the School of Pharmacy, University of London,
has attracted
funding from a joint Economic and Social Research Council and
Medical Research Council scheme to promote interdisciplinary working.
The
initiative aims to develop new research approaches
in children’s medicines.
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