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20 Jul 2001 : Column: 722W
Ms Blears: My right hon. Friend the Secretary of State travels using the most efficient and cost-effective mode of transport and would travel on the underground as and when appropriate. He has not, as yet, had occasion to travel on the London underground in the course of his official duties.
Ms Blears: As with all medicines, the safety of Prozac (fluoxetine) is continually monitored by the Medicines Control Agency (MCA) and the independent expert advisory body, the Committee on Safety of Medicines (CSM).
Part of this monitoring is via the Yellow Card scheme, where health professionals report suspected adverse drug reactions (ADRs) to the MCA/CSM. Doctors are reminded in the British National Formulary about the possibility of delayed adverse effects of medicines and that any suspicion of such an effect should be reported. All reports received are routinely assessed by the MCA. The other data sources regularly used in the monitoring of drug safety in the United Kingdom include formal safety studies, published medical literature, information from pharmaceutical companies and other regulatory authorities throughout the world together with information on the level of drug prescribing.
In 1998, the CSM conducted a detailed review of the safety profile of Prozac and other similar drugs with particular reference to concerns about dependence. The CSM advised that there was insufficient evidence to support such an association. This was published in "Current Problems in Pharmacovigilance" in September 2000.
Ms Blears: The Department, in partnership with the Wellcome Trust and the Medical Research Council, plans to establish a large prospective cohort of about 500,000 volunteers. The cohort will be used to study interactions between genetic, environmental and lifestyle risk factors to help determine the relative contribution of these factors in the development of chronic diseases in middle or adult later life. The scientific programme and the business plan for this initiative is under development with a view to obtaining final funding decisions early next year. It is anticipated that full cohort recruitment will start in 2003.
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made by his Department since 1 April in relation to under-25 year olds residing in England receiving free prescriptions in Wales; 
Ms Blears: None. The Department has regular contacts with the National Assembly for Wales at all levels on a wide range of health issues, but prescription charges and exemption arrangements within Wales are a matter for the National Assembly itself.
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Mr. Paul Marsden: To ask the Secretary of State for Health if he will make a statement on the progress being made on the replacement of wards on Copthorne South Site at the Royal Shrewsbury Hospital. 
Yvette Cooper: The move from Copthorne South and achieving its closure is a recognised priority both locally and regionally. The Royal Shrewsbury Hospital National Health Service Trust and the Princess Royal Hospital NHS are finalising the outline business case for phase 1 of the scheme, in partnership with Shropshire health authority.
Mr. Paul Marsden: To ask the Secretary of State for Health how many full-time equivalent staff work in (a) legal services, (b) estates management, (c) IT services, (d) administration and (e) management in (i) Royal Shrewsbury Hospital NHS Trust, (ii) Community and Mental Health NHS Trust and (iii) Shropshire health authority; and if he will make a statement. 
Yvette Cooper: The table shows a breakdown of all the administration and estates staff information available centrally. It is therefore not possible to identify separately staff within information technology services and legal services.
|All areas of work||Central functions||Hotel and property||Scientific, therapeutic and technical support||Clinical support||Ambulance service support|
|Shropshire Health Authority all staff||110||110||0||0||(69)||0|
|Clerical and Administrative||80||80||0||0||0||0|
|Royal Shrewsbury Hospitals NHS Trust all staff||370||130||30||50||150||(69)|
|Clerical and Administrative||320||120||10||50||140||(69)|
|Maintenance and Works||20||0||20||0||0||0|
|Shropshire's Community and Mental Health Services NHS Trust all staff||410||230||90||10||50||30|
|Clerical and Administrative||340||220||30||10||50||30|
|Maintenance and Works||60||0||60||0||0||(69)|
(69) Five or less and greater than zero.
1. Figures are rounded to the nearest 10
2. Due to rounding totals may not equal the sum of component parts. Figures exclude learners and agency staff
Department of Health Non-medical Workforce Census
Ms Blears: People under 18-years-old (under 19 if in full-time education); pregnant women; and women who have borne a child in the previous 12 months pay no charges for national health service dental care or treatment. Free dental care or treatment under the NHS is also available to those in receipt of certain benefits and tax credits. In addition, anyone on a low income may be entitled to full or partial remission of charges through the NHS low income scheme. We have no plans to introduce free dental check-ups for all and believe that it is a better use of scarce resources to focus help on those who need it most.
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Paul Flynn: To ask the Secretary of State for Health what percentage of medicines prescribed to (a) children and (b) adults (i) do not have full marketing authorisation by the Medicines Control Agency and (ii) are not licensed for all ages. 
Ms Blears [holding answer 17 July 2001]: In the United Kingdom, there is a legal exemption to allow supply of unlicensed medicines under certain conditions. This allows a doctor or dentist to prescribe an unlicensed medicine or a licensed medicine outside its licensed indications ('off-label' prescribing) for the special needs of his individual patient. For instance a doctor may prescribe a medicine for a child that is licensed only for adults. The Department has not undertaken research into such prescribing, or monitored the level of its use. However, reports in the literature of results of hospital- based surveys indicate that such prescribing is extensive in children. For example, in a neonatal intensive care unit around 90 per cent. of neonates received off-label or unlicensed medicines 1 ; in an intensive care unit around 70 per cent. of children received a medicine outside a licensed indication and 31 per cent. of prescriptions were for unlicensed or off-label use 2 ; and in a study of children in medical and surgical wards 25 per cent. of the products prescribed during the admission were for unlicensed indications 3 . In primary care the incidence of off-label or unlicensed prescribing to the paediatric population is thought to be around 10 per cent. 4 . Copies of the referenced papers will be placed in the Library. No similar evidence exists for adults.
We recognise the critical importance of this issue and agree that children should have access to medicines that have been fully evaluated to the same high standards of safety, quality and efficacy as those available for the adult population. The problem is not confined to the UK, but affects the whole of Europe and the United States of America. The UK is leading the call for action at a European level. Medicines regulation in the UK derives largely from European legislation and an international approach to the problem is therefore needed.
We have consequently raised the profile of this issue at a European level, including taking the lead in developing a European guideline, adopted in 1997, to encourage companies to undertake appropriate clinical trials on the use of medicines in the treatment of children. This formed the basis for an international guideline, which came into operation in January in the European Union, and also applies in the USA and Japan. In addition, the Council of the European Union has asked the European Commission to bring forward measures to make sure that medicines for children are fully adapted to their specific needs. We are presently waiting for their proposals. However, the Commission has stated its intention to comply with this request. The UK will play an active role in the development of this initiative to ensure that effective solutions are found.
In addition the Committee on Proprietary Medicinal Products (CPMP), the scientific advisory committee of the European Medicines Evaluation Agency (EMEA), recognising the importance of this topic has announced its intention to set up a paediatric expert group to advise the EMEA and its scientific committees on all questions
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relating to the development and use of medicinal products in children. The UK has nominated representatives to this paediatric expert group.
In the meantime, the UK Government have taken important steps at a national level within the existing regulatory framework. The Committee on Safety of Medicines (CSM), an independent expert committee that advises the licensing authority, asks companies for paediatric development plans where appropriate and has established a paediatric sub-group to provide expert advice on the licensing and safety of medicines for children. Product information for parents and carers is being simplified and the profile of monitoring the safety of medicines used in the treatment of children has been increased. Since 1998, the MCA has jointly funded a pilot scheme in Trent, the Paediatric Regional Monitoring Centre (PRMC), to stimulate reporting of adverse drug reactions (ADRs) to medicines used in the treatment of children. The scheme aimed to stimulate the reporting of suspected ADRs in children. The progress of the PRMC was reviewed after two years and it was concluded that it has been only of limited success. The MCA and CSM are now proposing to pursue a wider strategy to enhance existing data collection mechanisms and the lessons learned from the PRMC will be fully utilised in taking forward this strategy. The Government are committed to finding a long-term solution so that parents and carers can be reassured about the safety of medicines given to children.
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