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Written question asked by Paul Burstow (Liberal Democrat) on Monday, 25 October 2004, in the House of Commons. It was due for an answer on Wednesday, 3 November 2004. It was answered by Baroness Winterton of Doncaster (Labour) on Wednesday, 3 November 2004 on behalf of the Department of Health.


Dept of Health

Question
To ask the Secretary of State for Health, if he will estimate what proportion of medicines prescribed to (a) children and (b) infants have never been tested on children or infants; for what proportion of medicines prescribed to (a) children and (b) infants there is no agreed level of dosage; what recent assessment he has made of drugs which are not licensed for that purpose being used for the treatment of children ; what percentage of medicines used for treatment of children do not have a dosage approved by the Medicines and Healthcare Products Regulatory Agency; and if he will make a statement.
Answer

Mr. Burstow: To ask the Secretary of State for Health (1) if he will estimate what proportion of medicines prescribed to (a) children and (b) infants have never been tested on children or infants; [194246] (2) for what proportion of medicines prescribed to (a) children and (b) infants there is no agreed level of dosage; [194252] (3) what recent assessment he has made of drugs which are not licensed for that purpose being used for the treatment of children; [194255] (4) what percentage of medicines used for treatment of children do not have a dosage approved by the Medicines and Healthcare Products Regulatory Agency; and if he will make a statement. [194258] Ms Rosie Winterton: The Medicines and Healthcare Products Regulatory Agency (MHRA) does not have access to data in a form that would allow any of the requested estimates to be made. For many medicines, there is a dosage regimen for use in children and infants which has been agreed by an authoritative body of health professionals, based on clinical experience, medical practice and evidence from the published literature. Such dosage regimens, for example, are set out in the Medicines for Children Formulary, which is published by the Royal College of Paediatricians and Child Health and is to be replaced in 2005 by the British National Formulary for children, published by the British Medical Association and the Royal Pharmaceutical Society of Great Britain. However, the dosage regimens, although agreed by health professionals, are not necessarily authorised by the MHRA. We are unable to provide the percentage of medicines that do not have an authorised dosage regimen for use in children, as we do not hold data in that form. In addition, some medicines are authorised for some, but not all appropriate, paediatric age ranges.


Secondary information

Type
Written question
Reference
426 c317W; 194246;194252;194255;194258
Session
2003-04
Subjects
Children Drugs NHS Medical treatments Testing
Link
View this Written question on www.publications.parliament.uk