| Previous Section | Index | Home Page |
29 Nov 2005 : Column 406W—continued
Plagiocephaly
Jon Trickett: To ask the Secretary of State for Health (1) if she will require all primary care trusts to offer treatment for plagiocephaly; and if she will make a statement; [19503]
(2) if she will make a statement on the treatment of plagiocephaly. [19504]
Mr. Byrne: There is a difference between positional plagiocephaly, where flattening of the skull is caused by pressure from the surface on which a baby is customarily laid and craniosynostosis, where the cranial sutures have closed prematurely. In the latter case, surgery may well be necessary to prevent future health problems. The national service framework for children, young people and maternity services sets out standards to ensure that primary care trusts (PCTs) base decisions about treatments on the best evidence available to them. Treatment for plagiocephaly is available should doctors and PCTs consider it necessary.
Prescriptions
Mr. Holloway: To ask the Secretary of State for Health how many pre-payment certificates for prescriptions have been issued in Gravesham in each of the last 12 months. [29823]
Jane Kennedy: Information on the number of pre-payment certificates (PPCs) issued for Gravesham is not separately identifiable. However, the number of PPCs issued for England, by month for each of the last 12 months is as follows:
Primary Care Trusts
Mr. Ruffley: To ask the Secretary of State for Health what the projected spending from central Government funding was per head of the population for each primary care trust in England in 2004–05. [25071]
Mr. Byrne: The information requested has been placed in the Library.
Mr. Holloway: To ask the Secretary of State for Health what recent representations she has had from the local primary care trust in Gravesham; and on what subjects. [28601]
Caroline Flint:
There have been no representations to the Department from the local primary care trust in Gravesham.
29 Nov 2005 : Column 407W
Private Sector NHS Treatment
Clive Efford: To ask the Secretary of State for Health (1) whether guarantees have been given to private sectorproviders of health services regarding the proportion of NHS patient services that will be transferred to them; [17422]
(2) what discussions she has had with private sectorhealth providers regarding the transfer of NHS services; [17423]
(3) what guarantees private sector health providers have sought regarding the transfer of NHS services to enable them to secure financial backing for their businesses. [17424]
Mr. Byrne: Patients will decide if they want to use an independent or national health service service.
No guarantees have been given to private sector providers of health services regarding the proportion of NHS patient services that will be transferred to them.
No discussions have taken place with private sector health providers regarding the transfer of NHS services, and no guarantees have been sought. Providers will have to bid against the terms laid down by the Department.
Public Service Agreements
Mr. Philip Hammond: To ask the Secretary of State for Health what the time scales are for achievement of all aspects of 2004 public service agreement target number three. [29205]
Caroline Flint: The Department's public service agreement (PSA) targets and associated technical notes were agreed with HM Treasury as part of 2004 spending review and are published on the Department's website at www.dh.gov.uk. PSA technical notes contain the measurement details of the targets including what the specific time scales are for achievement of all aspects 2004 public service agreement target number three.
Recovery and Support Unit
Mr. Burstow: To ask the Secretary of State for Health what the role is of her Department's Recovery and Support Unit; and what information it collects. [29825]
Jane Kennedy: The recovery and support unit (RSU) is the team within the Department that works with strategic health authorities (SHA) on the performance of the national health service. SHAs are the local headquarters of the NHS and are responsible for the performance management of NHS trusts and primary care trusts. The RSU uses routine data collections from the NHS and in exceptional circumstances will make a specific request for data from SHAs on a specific issue.
Roaccutane
Nick Harvey:
To ask the Secretary of State for Health (1) what steps she (a) has taken and (b) is taking in response to the conclusion of the European-wide review of isotretinoin (Roaccutane) that (i) the psychiatric adverse events be kept under review and (ii) more frequent periodic safety update reports be produced than is usual for a product of Roaccutane's age; [31190]
29 Nov 2005 : Column 408W
(2) what research her Department has commissioned into the side effects of isotretinoin (Roaccutane); and what assessment she has made of the significance of (a) the Medical and Healthcare products Regulatory Agency review of paediatric data on isotretinoin and (b) the suicide of David Roberts while taking the drug. [31191]
Jane Kennedy: The European-wide review of isotretinoin was completed in October 2003. This review was led by the United Kingdom and resulted in the harmonisation of the product information for prescribers, summary of product characteristics, throughout Europe. The review also developed a set of important principles for nationally agreed pregnancy prevention programmes.
Warnings about depression and suicide have been present in the product information for isotretinoin since 1997. Since the completion of the European review, the issue of psychiatric reactions associated with isotretinoin has been considered by an expert working group of the Committee on Safety of Medicines on two occasions in 2003 and 2005. The reviews by the expert group led to the product information being expanded to include warnings about the possibility of further psychiatric adverse reactions. During their review the expert group conducted a thorough assessment of all reports of suicidal behaviour received in association with isotretinoin. The patient information leaflet for isotretinoin currently includes extensive warnings about the potential psychiatric side effects associated with isotretinoin treatment.
Following the European review, the marketing authorisation holders for isotretinoin are required to submit annual periodic safety update reports (PSURs), more frequently than the three-yearly PSURs required by legislation for a product of this age. These PSURs contain a summary of all information on safety from any data source in the period of the report.
The Medicines and Healthcare products Regulatory Agency (MHRA) Department's strategy on medicines for children was implemented in July 2004. As part of the strategy, the MHRA has been assessing clinical data in children for those medicines where such data are known to exist with a view to modifying the product information for these medicines where appropriate.
For isotretinoin, clinical data concerning its use in children was known to exist, as isotretinoin was included in the United States of America Food and Drug Administration's (FDA) list of active ingredients for which paediatric exclusivity had been granted. This data was obtained, and the MHRA assessment report of them was considered by the paediatric medicines working group of the Committee on Safety of Medicines. The assessment report has been published on the MHRA website.
The working group recommended that no changes to the product information for isotretinoin were necessary as a consequence of the review of this data. The group also recommended that the marketing authorisation holder should provide information regarding the adverse event reports received in children aged 13 to 17 years in future PSUR. These recommendations have been adopted by the MHRA.
29 Nov 2005 : Column 409W
The MHRA continually monitors the safety of isotretinoin and any new data, including that generated by research will be carefully considered and independent expert advice sought from the Commission on Human Medicines, which has replaced the Committee on Safety of Medicines and the Medicines Commission as the Government's independent expert advisory committee. Similarly all reports of suicidal behaviour associated with isotretinoin are carefully reviewed as part of the ongoing review of psychiatric reactions associated with isotretinoin.
| Next Section | Index | Home Page |