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Firms 'Must Develop
Child-Friendly Drugs'
By Tash Shifrin
The Guardian - UK
8-17-4
 
Drugs companies must focus more on the needs of children when developing new medicines, the health minister Lord Warner said today.
 
Launching a new paediatric medicines strategy, Lord Warner said he hoped it would send a "strong message" to pharmaceutical companies that they had a duty to research and develop medicines geared specifically to children's needs.
 
The move follows warnings from an expert working group of the government's committee on the safety of medicine (CSM) that a group of anti-depressant drugs known as SSRIs - selective serotonin reuptake inhibitors - which includes the best-selling Seroxat, should not be given to children. There was a risk that children taking the drugs might become suicidal and aggressive or suffer mood swings, the experts found.
 
Most medicines are designed for and tested on adults, although they may be widely prescribed for children. Treatments that are effective in adults may not be suitable for juveniles.
 
Plans under the new strategy include the creation of a separate British National Formulary for children - similar to the existing British National Formulary which gives healthcare professionals up-to-date information about the impact of medicines.
 
The paediatric medicines strategy aims to encourage drugs companies to provide much better data on clinical trials with children for new and existing medicines. It will also include measures to improve patient information leaflets so that they offer better information on the effects of certain medicines on children.
 
Part of the £100m allocated for medical research in the chancellor's budget will also be used to promote research on drugs for children, which will be co-ordinated by the UK Clinical Research Collaboration.
 
Lord Warner said: "Until now there hasn't been enough emphasis on developing medicines specifically for use in children, and the UK has led the way in pushing for change in this area.
 
"Work is in progress on a British National Formulary for children and we will provide funding for its publication and distribution as soon as it is ready. I want the new strategy that I have announced today to give a strong message to pharmaceutical companies to focus on the needs of children when developing new medicines.
 
"Health professionals need the latest information so that they can make the right choices about the medicines and treatments for their younger patients, and that is why the new British National Formulary for children is so important."
 
The British National Formulary (BNF), which is jointly published by the British Medical Association and the Royal Pharmaceutical Society of Great Britain, welcomed the announcement, particularly the commitment to fund a similar guide for children. The advisory for healthcare professionals is expected to be produced in print and electronic formats in June next year and will be updated annually.
 
Ian Costello, editor of the BNF for children, said: "The use of medicines in children is particularly complex. Because many medicines are not licensed for use in children, healthcare professionals currently have to rely on a variety of non-standard resources. Selecting the right medicine and calculating the right dose for a child can be particularly problematic and can make treatment more difficult.
 
"Healthcare 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."
 
Guardian Unlimited © Guardian Newspapers Limited 2004
 
http://www.guardian.co.uk/medicine/story/0,11381,1284890,00.html




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