§ Mr. AmessTo ask the Secretary of State for Health if he will provide funding to allow all NHS patients to access virus-inactivated plasma; and if he will make a statement. [74060]
§ Ms BlearsPlasma used for the production of blood products is virus inactivated and is already sourced from United States donors as a precaution against the theoretical risk of vCJD.
An announcement was made on 15 August 2002 that fresh frozen plasma (FFP) will be obtained from the United States for new born babies and children born after 1 January 1996. This measure is designed to protect the most vulnerable group who will not have been exposed to BSE through foodstuffs. The United States FFP will be subject to treatment with methylene blue to reduce the risk of transmission of blood borne viruses.
The Government expert advisory committee on the microbiological safety of blood and tissue for transplantation is continuing to keep this issue under review and there are currently no plans to allocate further funding.
795W
§ Mr. AmessTo ask the Secretary of State for Health for what reason the Government did not decide in 1998 to stop the use in transfusions of fresh frozen plasma derived from UK donors; and if he will make a statement. [74061]
§ Ms BlearsThe Government expert advisory committee on the microbiological safety of blood and tissues for transplantation did consider the importation of fresh frozen plasma (FFP) in 1998. The National Blood Service advised that sustainable supplies of imported plasma for FFP could not be obtained for the large number of patients every year who required it.
§ Sandra GidleyTo ask the Secretary of State for Health if she will apply the obligatory safety monitoring and other patient safeguards which are standard for licensed pharmaceutical products to fresh frozen plasma and methylene blue-treated fresh frozen plasma. [74204]
§ Ms BlearsThe Medicines Control Agency already ensures that the United Kingdom's blood services meet European good manufacturing practice standards. In addition, the new European Blood Directive will, when adopted, require the accreditation of all blood establishments to ensure common standards of safety and quality in blood and blood components across all Members States and the reporting of serious adverse reactions attributable to the safety and quality of blood and blood components.
The UK serious hazards of transfusion (SHOT) reporting system has had safety monitoring of fresh frozen plasma (FFP) and methylene blue treated FFP in place for five years. Although SHOT is a voluntary scheme the level of reporting compares favourably with reporting of suspected adverse drug reactions associated with licensed pharmaceuticals. Ninety two per cent. of hospitals in the UK already participate in SHOT and recent guidance to the National Health Service on the appropriate use of blood asks all hospitals to ensure participation www.doh.gov.uk/publications/coinh.html. SHOT publishes an annual report, and a copy of the most recent, for 2000–2001, has been placed in the Library.
The National Blood Service is developing a new patient information leaflet for all patients who will undergo a transfusion with blood or blood components.
§ Sandra GidleyTo ask the Secretary of State for Health when he will announce his decision regarding the funding for the provision of non-UK plasma; and if he will make a statement. [74205]
§ Ms BlearsPlasma used for the production of blood products is already sourced from United States donors as a precaution against the theoretical risk of vCJD.
An announcement was made on 15 August 2002 that fresh frozen plasma (FFP) will be obtained from the United States for new born babies and children born after 1 January 1996. This measure is designed to protect the most vulnerable group who will not have been exposed to BSE through foodstuffs.
The Government expert advisory committee on the microbiological safety of blood and tissue for transplantation is continuing to keep this issue under review.
796W
§ Jane GriffithsTo ask the Secretary of State for Health what measures are in place to prevent the transmissions of West Nile Fever in blood purchased from the United States for use in the UK. [74756]
§ Ms BlearsPlasma is currently imported from the United States for the production of plasma products, as a precaution against the theoretical risk of vCJD transmission. Viral inactivation of these products is carried out as a safety measure to remove the risk to patients of transfusion transmittable viruses, including West Nile fever virus, should it be present. The decision to import plasma for babies and young children born after 1 January 1996 from the United States was recently announced. This plasma will also undergo viral inactivation.
§ Mr. HavardTo ask the Secretary of State for Health for what reason methylene blue-treated fresh frozen plasma is being advocated for use in children and others by the National Blood Service; and what assessment he has made of its safety. [73932]
§ Ms BlearsAs an added precaution against the theoretical risk of vCJD transmission, the Government's expert advisory committee on the microbiological safety of blood and tissues for transplantation (MSBT) has recommended importing single unit fresh frozen plasma (FFP) from the United States. On 15 August 2002 the Government announced that imported FFP would be used for new-born babies and young children born after 1 January 1996.
On the advice of MSBT, US sourced FFP will be virally inactivated using methylene blue (MB) treatment. MB has been administered in medical practice since 1900, and in much larger doses, many thousand-fold, than the National Blood Service (NBS) will be using. NBS will be removing more than 90 per cent. of MB before the FFP is issued to National Health Service hospitals. MB is a registered medical device under the Medical Devices Directive and has a European safety (CE) marking.