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3 Nov 2004 : Column 316W—continued
Matrons
Mr. Jenkin: To ask the Secretary of State for Health how many people are employed as matrons by Essex Rivers Health Care at (a) Colchester General Hospital and (b) Essex County Hospital. [195832]
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Dr. Ladyman: The information requested is not collected centrally. Information is collected on the number of nurse managers, which includes matrons, at national health service trust level and figures for Essex Rivers Healthcare NHS Trust are shown in the table.
| RDE | |
|---|---|
| Essex Rivers Healthcare NHS Trust | |
| Whole-time equivalent | 4 |
| Headcount | 4 |
Note:
Whole-time equivalent figures are rounded to the nearest whole number.
Medicines (Children and Infants)
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.
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Mr. Burstow: To ask the Secretary of State for Health (1) what progress has been made on a European regulation to encourage more drug companies to research specific medicines for children; [194254]
(2) what steps he is taking to ensure that pharmaceutical companies in the United Kingdom provide clear dosage information for children and adults on all drugs they produce; and if he will make a statement. [194257]
Ms Rosie Winterton: The Government published on 17 August a strategy to produce improvements in the short and medium term in the availability of medicines licensed for use in the paediatric population and to improve the information available on paediatric use. This includes requesting companies to submit completed paediatric clinical trials and assessing the data with a view to including information on paediatric use in the summary of product characteristics (SmPC). The Medicines and Healthcare Products Regulatory Agency (MHRA) is also stressing the need to provide data on paediatric use in its discussions with companies prior to the submission of marketing authorisation applications. The MHRA offers free scientific and regulatory advice to companies wishing to discuss paediatric drug development and grants a fee waiver to applications for certain applications to introduce paediatric information into the SmPC. It will consult shortly on a fee waiver for new applications for authorisations for paediatric use.
The European Commission published a proposal for a Regulation on medicines for paediatric use on 29 September. It contains a requirement that companies provide paediatric data for all new applications for marketing authorisation and for certain changes to existing authorisations. The member states will begin discussing the text of the draft Regulation on October 29 under the Dutch presidency. The United Kingdom will have an opportunity to drive the negotiations forward during its presidency in the second half of 2005. It is anticipated that the Regulation will not be finalised before the end of 2006.
Mr. Burstow: To ask the Secretary of State for Health what estimate he has made of the number of children who (a) died and (b) were injured as a result of treatment with drugs not licensed for the treatment of children in each of the last five years; and if he will make a statement. [194256]
Ms Rosie Winterton: The following table shows the total number of suspected adverse drug reaction (ADR) reports received via the yellow card scheme from 1 January to 31 December for each of the last five years, where the patient age was specified as 18 years or less. We do not have a sub-analysis of reports received in association with medicines not licensed for use in children.
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Please note that data held on the adverse drug reactions on-line information tracking (ADROIT) database is dynamic and may be subject to change.
It is important to note that a report of an adverse drug reaction does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease.
Mr. Burstow: To ask the Secretary of State for Health what plans he has to introduce a system of learning from the yellow card system about the correct dosage and prescribing methods for medicines for children. [194259]
Ms Rosie Winterton: The yellow card scheme is not designed to enable lessons to be drawn about correct dosage or prescribing methods for medicines for children. There are no plans to introduce a system of learning in this context.
Reports of suspected adverse drug reactions (ADRs) are held on a purpose designed computer database known as the adverse drug reactions on-line information tracking (ADROIT) database, which was introduced in 1991. Data held on ADROIT is dynamic and may be subject to change.
The Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency (CSM/MHRA) request that all suspected ADRs which occur in children are reported, regardless of whether the medicine is licensed for use in children. This is because the nature and course of illness and ADRs may differ between adults and children. In general, children are not exposed to medicines in clinical trials, many drugs which are routinely used to treat children are not licensed for use in this age group. It is therefore particularly important to focus on the safety of medicines in children.
We are interested in any side effects of medicines as used in clinical practice, regardless of whether they are being used according to the terms of the licence, as described in the product information.
It is important that we are aware of side effects which arise when medicines are used "off label", so that we can act to warn health professionals if necessary. However, the treatment of individual patients remains the responsibility of the doctor.
Mr. Burstow: To ask the Secretary of State for Health what progress has been made on the initiative in the Trent region to encourage reporting of adverse drug reactions in the use of medicines in the treatment of children. [194260]
Ms Rosie Winterton:
Between 1998 and 2001 the Medicines Control Agency (MCA) the predecessor of the Medicines and Healthcare products Regulatory Agency (MHRA) funded a pilot scheme in Trent to stimulate reporting of adverse drug reactions (ADRs) to medicines used in the treatment of children. The project had limited success in stimulating reporting. Following on from this and using lessons learned, the MHRA has pursued a wider strategy to enhance existing data collection mechanisms.
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This has included working with the British Paediatric Surveillance Unit (BPSU), of the Royal College of Paediatricians and Child Health and working with the Committee on Safety of Medicines Regional Monitoring Centres to promote ADR reporting in children.
The strategy will be taken forward in the European Regulation on medicines for paediatric use. In addition the MHRA is currently leading the development of a European guideline on paediatric pharmacovigilance.
Mr. Burstow: To ask the Secretary of State for Health if he will estimate the (a) time spent in hospitals and (b) cost involved in treating a person who has experienced an adverse drug reaction. [194261]
Ms Rosie Winterton: We do not hold data to answer this question. However a recent study, funded by the Medicines and Healthcare products Regulatory Authority and published in the British Medical Journal, provides relevant information. 1
Of 18,820 patients aged over 16 years admitted to hospital over a six month period and assessed for cause of admission, there were 1,225 admissions judged to be related to an adverse drug reaction (ADR), giving a prevalence of 6.5 per cent. Of these 1,225, the ADR was judged to lead directly to the admission in 80 per cent. of cases. The median bed stay was eight days, accounting for 4 per cent. of the hospital bed capacity. The projected annual cost of such admissions to the NHS is £466 million. The overall fatality was 0.15 per cent. Most reactions were either definitely or possibly avoidable. Drugs most commonly implicated in causing these admissions included low dose aspirin, diuretics, warfarin, and non-steroidal anti-inflammatory drugs other than aspirin, the most common reaction being gastrointestinal bleeding. There was no assessment made of whether the ADR was associated with off-label or unlicensed use.
British Medical Journal. 2004 July 3;329(7456):15–9 Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. Pirmohamed M., James S., Meakin S., Green C., Scott A.K., Walley T.J., Farrar K., Park B.K., Breckenridge A.M. Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool L69 3GE.
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