- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive what plans there are for any products still held by Scottish National Blood Transfusion Service’s Protein Fractionation Centre.
Answer
Following the Medicines andHealthcare products Regulatory Agency (MHRA) inspection in January 2006, adecision was taken by the Scottish Blood Transfusion Service not to issueproducts from the Protein Fractionation Centre (PFC) to NHS Scotland except inthe case of clinical need. The products still held at the PFC are unlikely tobe used as they were produced before this date.
However, some in-dateproducts will be retained as contingency stocks, but will only be issued withthe approval of the MHRA. These are mainly specific specialist hyper-immuneplasma products.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive whether NHS Scotland is experiencing any shortage of plasma products.
Answer
There is no shortage ofplasma products within NHS Scotland. NHS National ServicesScotland has put contracts in place with other manufacturers for the long termsupply of products previously manufactured by the Scottish National BloodTransfusion Service at the Protein Fractionation Centre.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive whether any products have been destroyed since production restarted at the Scottish National Blood Transfusion Service’s Protein Fractionation Centre and, if so, what these products were, what quantity was involved and what the reasons were for their destruction.
Answer
Material used to test partof the Protein Fractionation Centre (PFC) production processes as well asout-of-date products, returns and quality samples have been disposed of.
Some part processed productswhich were not fit for further processing were discarded in September 2006.
The disposal of startingmaterials, intermediate products and finished products from the PFC is carriedout in compliance with the quality assurance procedures that are in place.
The following table showsproducts discarded at the PFC since 1 September 2006:
Product | Quantity | Reason For Discard |
| Human Albumin | 5,168g 1,070g | Expired Reject |
| Human Immunoglobulin for intravenous infusion | 945g 2672g | Expired Reject |
| Human Immunoglobulin for intramuscular infusion | 239 vials 277 vials | Expired Reject |
| Coagulation Factors | 43 kits 21 vials | Expired Reject |
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive from where it procures plasma products.
Answer
Plasma from Scotland’sblood donors has not been used to produce plasma products since 1998, due tothe risk posed by variant Creutzfeldt-Jacob Disease (vCJD).
Plasma products arepurchased by NHS National Services Scotland from a range of suppliers in Europe andthe US, who hold appropriate UK regulatory approvals for their plasma sources,manufacturing facilities and products, on a competitive tendering basis. Theseinclude:
Baxter Health Care; CSLBehring; Octapharma; Grifols; Biotest and Bio-Products Laboratory.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive whether any Scottish National Blood Transfusion Service Protein Fractionation Centre products were used by the NHS during the recent period of voluntary suspension and, if so, by whom and for what purpose.
Answer
While production atthe Protein Fractionation Centre (PFC) was voluntarily suspended, products remainedlicensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and arange of PFC products were issued under MHRA approval. These products were for thetreatment of patients with clotting disorders, burns, and those who required antibodyreplacement and prophylaxis for a range of conditions.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive when the Medicines and Healthcare Products Regulatory Authority first gave approval for the Scottish National Blood Transfusion Service’s Protein Fractionation Centre to restart operations after the voluntary suspension in January 2006.
Answer
The Medicines and Healthcareproducts Regulatory Agency granted approval to restart production of plasma productsfor clinical use on 14 September 2006. A follow-up inspection took place in February 2007.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive what the annual cost is of the contract with Bio Products Laboratory to supply products to NHS Scotland.
Answer
The annual cost of the contractwith Bio-Products Laboratory is £3.3 million.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive which products have been produced by the Scottish National Blood Transfusion Service’s Protein Fractionation Centre since it restarted production.
Answer
The Protein Fractionation Centrehas produced only one product for clinical use, a batch of anti-botulinum toxin,which will be issued to the Ministry of Defence during March 2007. This will havefull approval of the Medicines and Healthcare products Regulatory Agency.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Friday, 23 February 2007
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Current Status:
Answered by Andy Kerr on 7 March 2007
To ask the Scottish Executive what the length of contract is with Bio Products Laboratory to supply plasma products to NHS Scotland and on which date the contract commenced.
Answer
The contract with Bio-ProductsLaboratory commenced in June 2006 and extends to April 2008.
Between January and June 2006,plasma products were sourced from various contractors whilst a formal procurementprocess was put in place and the contract awarded.
- Asked by: Shona Robison, MSP for Dundee East, Scottish National Party
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Date lodged: Tuesday, 20 February 2007
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Current Status:
Answered by Lewis Macdonald on 6 March 2007
To ask the Scottish Executive how many people had to wait for hearing tests after referral in each year since 1999, broken down by NHS board.
Answer
I refer the member to the answer to question S2W-31888 on 6 March 2007. All answers to written parliamentary questions are availableon the Parliament’s website, the search facility for which can be found at
http://www.scottish.parliament.uk/webapp/wa.search.
