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386923
registered interest false more like this
date remove maximum value filtermore like thismore than 2015-07-01
answering body
Department of Health more like this
answering dept id 17 more like this
answering dept short name Health more like this
answering dept sort name Health more like this
hansard heading Vitamin B12 more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government what steps they are taking to find an alternative and reliable test to assess the vitamin B12 status of the population; and what level of false high results the current test provides. more like this
tabling member printed
The Countess of Mar remove filter
uin HL1032 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-07-14more like thismore than 2015-07-14
answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
answering member printed Lord Prior of Brampton more like this
grouped question UIN
HL1033 more like this
HL1034 more like this
HL1035 more like this
HL1036 more like this
HL1042 more like this
question first answered
less than 2015-07-14T15:00:41.673Zmore like thismore than 2015-07-14T15:00:41.673Z
answering member
127
label Biography information for Lord Prior of Brampton more like this
attachment
1
file name colbalamin and folate disorders.pdf more like this
title BSCH Guidance more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
386924
registered interest false more like this
date remove maximum value filtermore like thismore than 2015-07-01
answering body
Department of Health more like this
answering dept id 17 more like this
answering dept short name Health more like this
answering dept sort name Health more like this
hansard heading Vitamin B12 more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government whether they plan to review how pernicious anaemia and other symptoms of vitamin B12 deficiency in the United Kingdom population are diagnosed and treated, particularly taking into account the neurological and mental health impact of any failure to diagnose quickly and accurately; and, if not, why not. more like this
tabling member printed
The Countess of Mar remove filter
uin HL1033 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-07-14more like thismore than 2015-07-14
answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
answering member printed Lord Prior of Brampton more like this
grouped question UIN
HL1032 more like this
HL1034 more like this
HL1035 more like this
HL1036 more like this
HL1042 more like this
question first answered
less than 2015-07-14T15:00:41.81Zmore like thismore than 2015-07-14T15:00:41.81Z
answering member
127
label Biography information for Lord Prior of Brampton more like this
attachment
1
file name colbalamin and folate disorders.pdf more like this
title BSCH Guidance more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
386925
registered interest false more like this
date remove maximum value filtermore like thismore than 2015-07-01
answering body
Department of Health more like this
answering dept id 17 more like this
answering dept short name Health more like this
answering dept sort name Health more like this
hansard heading Vitamin B12 more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government what steps they are taking to ensure that a reliable test to assess the vitamin B12 status of the United Kingdom population is made available as a means to prevent serious and irreversible neurological damage before any mandatory fortification of flour with folic acid is introduced. more like this
tabling member printed
The Countess of Mar remove filter
uin HL1034 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-07-14more like thismore than 2015-07-14
answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
answering member printed Lord Prior of Brampton more like this
grouped question UIN
HL1032 more like this
HL1033 more like this
HL1035 more like this
HL1036 more like this
HL1042 more like this
question first answered
less than 2015-07-14T15:00:41.947Zmore like thismore than 2015-07-14T15:00:41.947Z
answering member
127
label Biography information for Lord Prior of Brampton more like this
attachment
1
file name colbalamin and folate disorders.pdf more like this
title BSCH Guidance more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
386926
registered interest false more like this
date remove maximum value filtermore like thismore than 2015-07-01
answering body
Department of Health more like this
answering dept id 17 more like this
answering dept short name Health more like this
answering dept sort name Health more like this
hansard heading Vitamin B12 more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government what assessment they have made of the frequency at which patients with pernicious anaemia require vitamin B12 replacement therapy by injection; whether they have any evidence that patients are purchasing additional supplies from unregulated sources; and whether they will review current guidance. more like this
tabling member printed
The Countess of Mar remove filter
uin HL1035 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-07-14more like thismore than 2015-07-14
answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
answering member printed Lord Prior of Brampton more like this
grouped question UIN
HL1032 more like this
HL1033 more like this
HL1034 more like this
HL1036 more like this
HL1042 more like this
question first answered
less than 2015-07-14T15:00:42.073Zmore like thismore than 2015-07-14T15:00:42.073Z
answering member
127
label Biography information for Lord Prior of Brampton more like this
attachment
1
file name colbalamin and folate disorders.pdf more like this
title BSCH Guidance more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
386927
registered interest false more like this
date remove maximum value filtermore like thismore than 2015-07-01
answering body
Department of Health more like this
answering dept id 17 more like this
answering dept short name Health more like this
answering dept sort name Health more like this
hansard heading Vitamin B12 more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government whether they have assessed the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies; and, if so, what they consider them to be. more like this
tabling member printed
The Countess of Mar remove filter
uin HL1036 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-07-14more like thismore than 2015-07-14
answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
answering member printed Lord Prior of Brampton more like this
grouped question UIN
HL1032 more like this
HL1033 more like this
HL1034 more like this
HL1035 more like this
HL1042 more like this
question first answered
less than 2015-07-14T15:00:42.183Zmore like thismore than 2015-07-14T15:00:42.183Z
answering member
127
label Biography information for Lord Prior of Brampton more like this
attachment
1
file name colbalamin and folate disorders.pdf more like this
title BSCH Guidance more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
385707
registered interest false more like this
date less than 2015-06-25more like thismore than 2015-06-25
answering body
Department for Transport more like this
answering dept id 27 more like this
answering dept short name Transport more like this
answering dept sort name Transport more like this
hansard heading Aircraft: Air Conditioning more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government whether the Cranfield study on cabin air ever collected reliable information on the concentration of organophosphates in a visible fume event; and if so, what the quantitative figures collected were. more like this
tabling member printed
The Countess of Mar remove filter
uin HL831 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-07-08more like thismore than 2015-07-08
answer text <p>The Cranfield University report of May 2011 successfully completed a range of air quality measurements during the course of 100 flights. Flight and cabin crew, as well as the investigating scientists reported a number of fume /smell events in a post-flight questionnaire. Samples specifically taken during recorded air quality events did not have notably elevated concentrations of any of the individually measured pollutants.</p><p> </p><p>Further detailed figures and measurements can be found in the Cranfield report.</p><p> </p> more like this
answering member printed Lord Ahmad of Wimbledon more like this
question first answered
less than 2015-07-08T13:18:12.967Zmore like thismore than 2015-07-08T13:18:12.967Z
answering member
4210
label Biography information for Lord Ahmad of Wimbledon more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
350104
registered interest false more like this
date less than 2015-06-11more like thismore than 2015-06-11
answering body
Department for International Development more like this
answering dept id 20 more like this
answering dept short name International Development more like this
answering dept sort name International Development more like this
hansard heading West Africa: Ebola more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government what has been the total cost so far of providing personnel from the Ministry of Defence, National Health Service and Public Health England, and materials and medicines from the United Kingdom, to international efforts to tackle the recent ebola crisis. more like this
tabling member printed
The Countess of Mar remove filter
uin HL418 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-06-25more like thismore than 2015-06-25
answer text <p>The UK has committed £427m to combat Ebola in West Africa, £373m for the ongoing response and £54m for early recovery programmes. This package of support covers the cost of UK operations, including Ministry of Defence assets and personnel, PHE clinicians, materials and medicines. Over £260 million has now been disbursed.</p> more like this
answering member printed Earl of Courtown more like this
question first answered
less than 2015-06-25T16:39:51.273Zmore like thismore than 2015-06-25T16:39:51.273Z
answering member
3359
label Biography information for The Earl of Courtown more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
350105
registered interest false more like this
date less than 2015-06-11more like thismore than 2015-06-11
answering body
Department for Work and Pensions more like this
answering dept id 29 more like this
answering dept short name Work and Pensions more like this
answering dept sort name Work and Pensions more like this
hansard heading Prescribed Industrial Diseases more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government how many claims they have received for Prescribed Disease C3b in the last 10 years; and of these, how many were allowed. more like this
tabling member printed
The Countess of Mar remove filter
uin HL419 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-06-18more like thismore than 2015-06-18
answer text <p /> <p>The information as requested is not available and could only be provided at disproportionate cost.</p> more like this
answering member printed Baroness Altmann more like this
question first answered
less than 2015-06-18T13:40:56.02Zmore like thismore than 2015-06-18T13:40:56.02Z
answering member
4533
label Biography information for Baroness Altmann more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
350106
registered interest false more like this
date less than 2015-06-11more like thismore than 2015-06-11
answering body
Department for Work and Pensions more like this
answering dept id 29 more like this
answering dept short name Work and Pensions more like this
answering dept sort name Work and Pensions more like this
hansard heading Sheep Dipping more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government, further to the statement by George Eustice, Minister of State, Department for Environment, Food and Rural Affairs, on 10 June (HC Deb, col 136WH), who published the 1991 Health and Safety Executive report of an inquiry into sheep dipping; and to whom it was distributed. more like this
tabling member printed
The Countess of Mar remove filter
uin HL420 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2015-06-18more like thismore than 2015-06-18
answer text <p /> <p>The 1991 Health and Safety Executive (HSE) report presented the findings of a 1990 survey of sheep dipping and was published by HSE as an internal document in May 1991.</p><p> </p><p>The report was discussed at a meeting of the then Health and Safety Commission’s Agricultural Industry Advisory Committee (AIAC) working group, Chemicals In Agriculture (ChemAg), on 10 July 1991. The ChemAg working group membership included HSE, the Confederation of British Industry, the Trades Union Congress and other industry organisations.</p> more like this
answering member printed Baroness Altmann more like this
question first answered
less than 2015-06-18T13:32:17.067Zmore like thismore than 2015-06-18T13:32:17.067Z
answering member
4533
label Biography information for Baroness Altmann more like this
tabling member
1861
label Biography information for The Countess of Mar more like this
347943
registered interest false more like this
date less than 2015-06-02more like thismore than 2015-06-02
answering body
Department of Health more like this
answering dept id 17 more like this
answering dept short name Health more like this
answering dept sort name Health more like this
hansard heading Human Papillomavirus: Vaccination more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty’s Government, to date, how many adverse reactions to (1) Cervarix, (2) Gardasil and (3) generic human papilloma virus vaccines have been reported to the Medicines and Healthcare products Regulatory Agency; for each category, how many of those reports are of serious adverse reactions; and what age-specific rate those figures represent. more like this
tabling member printed
The Countess of Mar remove filter
uin HL229 more like this
answer
answer
is ministerial correction true more like this
date of answer less than 2015-06-16more like thismore than 2015-06-16
answer text <p>A total of 8,243 suspected adverse drug reaction (ADR) reports with human papilloma virus (HPV) vaccines have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA), via the Yellow Card Scheme, up to 3 June 2015.</p><p> </p><p> </p><p> </p><p>To date, more than 8 million doses of HPV vaccine have been given across the United Kingdom as part of the routine immunisation programme. The MHRA does not hold data on age-specific vaccine usage, and therefore age-specific reporting rates cannot be calculated.</p><p> </p><p> </p><p> </p><p>It is important to note that a Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine may have been the cause. Yellow Card data cannot be used as a reliable indicator of the frequency of suspected ADRs to vaccines or medicines. The level of ADR reporting may fluctuate between given years due to a variety of reasons such as a medicine being new (reporting rates are generally higher when a product is first introduced), stimulated interest/publicity and variations in exposure to the medicine.</p><p> </p><p> </p><p> </p><p>The possible known side effects, and the frequency, are listed in the product information which is provided with the vaccines. The vast majority of the 8,243 ADRs relate to the known risks of vaccination that are well-described in the available product information. The proportion of suspected ADRs for HPV vaccines that were reported as serious (32%) is less than the proportion reported as serious for other routinely used vaccines (68% overall) during the same time period. The expected benefits in protecting against HPV-related mortality and disease outweigh the known side effects of HPV vaccine.</p><p> </p><p> </p><p> </p><p>The following table provides a breakdown of UK suspected spontaneous ADRs received via the Yellow Card Scheme in association with the HPV vaccine. The MHRA does not hold data on age-specific vaccine usage, and therefore age-specific reporting rates cannot be calculated.</p><p> </p><p> </p><p> </p><table><tbody><tr><td><p>Vaccine Brand</p></td><td><p>Total number of reports</p></td><td><p>Number of serious reports (% of total)</p></td><td><p>Reporting rate per 1000 doses (serious reporting rates per 1000)</p></td></tr><tr><td><p>Cervarix</p></td><td><p>6,266</p></td><td><p>1,768 (28%)</p></td><td><p><ins class="ministerial">n/a **</ins><del class="ministerial">0.78 (0.22)</del></p></td></tr><tr><td><p>Gardasil</p></td><td><p>1,471</p></td><td><p>504 (34%)</p></td><td><p><ins class="ministerial">n/a **</ins><del class="ministerial">0.18 (0.06)</del></p></td></tr><tr><td><p>HPV Brand unspecified</p></td><td><p>507</p></td><td><p>326 (64%)</p></td><td><p><ins class="ministerial">n/a ** </ins><del class="ministerial">0.06 (0.04)</del></p></td></tr><tr><td><p>Total for Human Papilloma virus vaccines</p></td><td><p>*8,244</p></td><td><p>2,598 (32%)</p></td><td><p>1.03 (0.32)</p></td></tr></tbody></table><p> </p><p><em>Source:</em> MHRA sentinel database for adverse reactions.</p><p> </p><p>* It should be noted that the total number of reports received will not be equal to the totals in the table above as some reports of suspected adverse reactions may have included more than one vaccine.</p><p><ins class="ministerial">**Updated UK-wide brand-specific usage data are not available to MHRA at the time of writing based on a minimum of 8 million combined doses of Cervarix and Gardasil administered across the UK to date.</ins></p><p> </p><p><ins class="ministerial"> <p> </p><p> </p><p> </p></ins></p><p> </p><p> </p><p> </p><p> </p><p> </p><p>The seriousness criteria for ADR reporting were determined by a working group of the Council for International Organizations of Medical Sciences (CIOMS) and are defined as 6 possible categories which are explained on the Yellow Card. The MHRA asks reporters to select one of the following criteria by ticking the appropriate box on the Yellow Card: (1) patient died due to reaction; (2) life threatening; (3) resulted in hospitalisation or prolonged inpatient hospitalisation; (4) congenital abnormality; and (5) involved persistent or significant disability or incapacity; or (6) if the reaction was deemed medically significant. In addition to this, seriousness of reaction terms has also been defined by the MHRA in its medical dictionary. Therefore an ADR report can be serious because the reporter considers the reaction to be serious or because the reaction term itself is considered serious in the MHRA medical dictionary.</p><p> </p>
answering member printed Lord Prior of Brampton more like this
question first answered
less than 2015-06-16T14:35:02.313Zmore like thismore than 2015-06-16T14:35:02.313Z
question first ministerially corrected
less than 2015-07-03T14:01:13.16Zmore like thismore than 2015-07-03T14:01:13.16Z
answering member
127
label Biography information for Lord Prior of Brampton more like this
previous answer version
5462
answering member printed Lord Prior of Brampton more like this
answering member
127
label Biography information for Lord Prior of Brampton more like this
tabling member
1861
label Biography information for The Countess of Mar more like this