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228976

registered interest
date	23/03/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Pharmacy
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what will be the position of patients, previously served by a dispensing doctor practice, who live within 1.6 km of a pharmacy that closes, but still retains its licence, as a result of the closure of the Essential Small Pharmacies Scheme on 1 April 2015.
tabling member printed	The Countess of Mar
uin	HL5941
answer	answer is ministerial correction date of answer 25/03/2015 answer text <p>The ending of the essential small pharmacy local pharmaceutical services scheme on 31 March 2015 does not require such pharmacies to close. That is a decision for the individual contractor concerned. They may decide to return to the main National Health Service pharmaceutical list and come under the terms of the national community pharmacy contractual framework. Alternatively, they can decide to submit a proposal to NHS England to provide local pharmaceutical services. NHS England is working with individual providers of essential small pharmacies to ensure people in affected communities can continue to access appropriate NHS pharmaceutical services. However, if an essential small pharmacy – or any other type of pharmacy - did decide to close, it would no longer be able to provide NHS pharmaceutical services.</p><p> </p><p> </p><p> </p><p>Patients can at any time request in writing that a doctor provides them with NHS pharmaceutical services. Applications should be made via the doctor to the appropriate NHS England office. To be eligible to receive dispensing services from a doctor, a patient must meet certain criteria, such as having serious difficulty obtaining services from a pharmacy or the patient lives in a designated rural area, more than 1.6 kilometres from the nearest pharmacy. These criteria are set out in Regulation 48 of the National Health Services (Pharmaceutical Services and Local Pharmaceutical Services) Regulations 2013 – SI 2013/349. A patient must also be on the doctor’s patient list, or the patient list of the practice at which the doctor provides or performs primary medical services, and the practice must be authorised by NHS England to provide NHS dispensing services.</p><p> </p> answering member printed Earl Howe question first answered 25/03/2015 16:21:09 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

167280

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government how many adverse reactions to Cervarix, Gardasil and unbranded human papilloma virus vaccines have been reported to the Medicines and Healthcare Products Regulatory Agency up to the most recent date; how many of those reports are of serious adverse reactions for each category; and what is the age specific rate that these figures represent.
tabling member printed	The Countess of Mar
uin	HL3381
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>A total of 7947 suspected adverse reaction 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 December 2014. 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. The frequency of known side effects is listed in the product information (the Summary of Product Characteristics for health professionals and the Patient Information Leaflet) which are provided with the vaccines.</p><p> </p><p> </p><p> </p><p>The following table provides a breakdown of these reports by brand and seriousness.</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></tr><tr><td><p>Cervarix</p></td><td><p>6,260</p></td><td><p>1,762 (28%)</p></td></tr><tr><td><p>Gardasil</p></td><td><p>1,200</p></td><td><p>459 (38%)</p></td></tr><tr><td><p>HPV Brand unspecified</p></td><td><p>488</p></td><td><p>308 (63%)</p></td></tr><tr><td><p>Total</p></td><td><p>7,948*</p></td><td><p>2529 (32%)</p></td></tr></tbody></table><p> </p><p><em>Note:</em></p><p> </p><p>*The total number of reports received will not equal the total in the table above as some reports may have more than one suspect vaccine.</p><p> </p><p> </p><p> </p><p>The MHRA does not hold data on age-specific usage therefore we are unable to provide the age-specific rate that these figures represent. The MHRA continually reviews safety of the vaccine and, following administration of over 7 million doses in the UK alone, no serious new risks have been identified. The benefits in protecting against HPV-related disease far outweigh any possible side effects of the vaccine.</p><p> </p> answering member printed Earl Howe question first answered 16/12/2014 15:34:13 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

166877

registered interest
date	01/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Medical Records
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether clinical commissioning groups, general practitioner surgeries or any other National Health Service bodies have the legal right to provide insurance companies, or anyone else outside the National Health Service, with patients’ details, including their medical details; if so, which legislation permits such action; and, if any payment is received for supplying such information, to whom it is made.
tabling member printed	The Countess of Mar
uin	HL3295
answer	answer is ministerial correction date of answer 05/12/2014 answer text <p>In the vast majority of cases National Health Service organisations may only provide confidential information about a patient to insurance companies and other third parties such as employers with the explicit consent of the patient. However, there may be a small number of cases where disclosure may take place without seeking consent, for example where there is a court order. Healthcare professionals who supply medical reports to insurance companies and employers may charge a fee for doing so; NHS organisations that supply copies of medical records may charge a fee that covers their costs.</p><p> </p> answering member printed Earl Howe question first answered 05/12/2014 14:32:42 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

156576

registered interest
date	19/11/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Diseases
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government which organisations within the National Health Service or which represent members who provide services to the National Health Service are bound by the World Health Organisation’s International Classification of Diseases (ICD—10).
tabling member printed	The Countess of Mar
uin	HL2999
answer	answer is ministerial correction date of answer 26/11/2014 answer text <p>The United Kingdom as a member state of the World Health Organization (WHO) is expected to comply with the WHO Nomenclature Regulations 1967 and is required to use the most current version of the International Classification of Diseases (ICD-10) for reporting cause of death and disease for compiling and publishing mortality and morbidity statistics. As such all providers of National Health Service funded care are required to submit ICD-10 codes for national reporting.</p><p> </p> answering member printed Earl Howe question first answered 26/11/2014 12:58:45 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

156577

registered interest
date	19/11/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Chronic Fatigue Syndrome
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government why they do not record the numbers of people who are diagnosed with chronic fatigue syndrome/myalgic encephalomyelitis, given that current estimates are based on extrapolations from other countries.
tabling member printed	The Countess of Mar
uin	HL3000
answer	answer is ministerial correction date of answer 27/11/2014 answer text <p>With the exception of cancer, there is no comprehensive central record of disease diagnosis for any condition. In 2007, the National Institute for Health and Care Excellence produced the clinical guidance, <em>Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): Diagnosis and management of CFS/ME in adults and children</em> which estimates that the annual prevalence is approximately 4000 cases per million of the population.</p><p> </p> answering member printed Earl Howe question first answered 27/11/2014 12:42:01 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

93428

registered interest
date	14/10/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Aspartame
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government when they intend to publish the results of the Hull trial on aspartame on the Food Standards Agency website.
tabling member printed	The Countess of Mar
uin	HL2094
answer	answer is ministerial correction date of answer 24/10/2014 answer text <p>The Food Standards Agency (FSA) advise that the paper is still in the peer-review process. Publication in a scientific journal is expected and is the preferable route as it makes the data more readily available to the scientific community. Once this happens the FSA will publish the final report on foodbase, the FSA’s open access repository.</p><p> </p> answering member printed Earl Howe question first answered 24/10/2014 11:26:46 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

79197

registered interest
date	21/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 25 June 2012 (WA 21–2), whether they consider that the use of the CE-marked Trinity Biotech EU Lyme western blot test, when used with cerebrospinal fluid, would constitute "use of an in-house test" as defined by the Medical and Healthcare Products Regulatory Agency guidance.
tabling member printed	The Countess of Mar
uin	HL1358
answer	answer is ministerial correction date of answer 29/07/2014 answer text <p>Use of a sample type not indicated by the manufacturer would be considered to be off label use of the device. This off label use is not regulated by the Medicines and Healthcare products Regulatory Agency and would be the responsibility of the laboratory.</p> answering member printed Earl Howe question first answered 29/07/2014 13:16:10 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77264

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government when the testing of the cerebrospinal fluid of patients suspected of having Lyme disease using the Trinity Biotech kit at the Health Protection Agency’s Lyme Borreliosis Unit began; how many patients' samples were tested in that way; and how many patients were recorded as being positive over that period of time.
tabling member printed	The Countess of Mar
uin	HL998
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The Trinity Biotech blot has been in use since 2007 by the former Health Protection Agency's Lyme Borreliosis Unit for testing cerebrospinal fluid (CSF) and proved very reliable. It has also been used in this way by other laboratories in Europe. However, CSF antibodies will not be present if there is no evidence of any other antibodies in the serum. Data is not collected centrally on specific samples from patients as the final diagnosis is made by the clinician on the basis of the test results and the clinical presentation.</p> answering member printed Earl Howe question first answered 24/07/2014 12:31:17 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77265

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether, in December 2011, the Clinical Pathology Accreditation Service was made aware of modifications by the Health Protection Agency’s Lyme Borreliosis Unit to the Trinity Biotech immunoblot kit to be used for testing human cerebrospinal fluid.
tabling member printed	The Countess of Mar
uin	HL999
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's Lyme Borreliosis Unit (HPA LBU) was accredited by Clinical Pathology Accreditation who had access to, and was able to review, all the standard operating procedures of the unit.</p><p> </p><p>The Trinity Biotech Lyme Western Blot is a qualitative in vitro assay for the detection of Immunoglobulin (IgG or IgM) antibodies in human samples against specific antigens/proteins of <em>Borrelia afzelii, Borrelia garinii and Borrelia burgdorferi</em>. The Trinity Biotech Lyme Western Blot is intended as a confirmatory assay for use in testing human samples which have been previously found to be positive or equivocal using an Enzyme Immunoassay and Immunofluroescent Assay or other appropriate screening method. Positive second-tier results are supportive evidence of infection with <em>B. burgdorferi</em>. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to <em>B. burgdorferi</em>. The Trinity Biotech blot has been in use since 2007 by the former HPA’s LBU for testing cerebrospinal fluid (CSF) and proved very reliable. This technique has also been in use widely across Europe during this period as a diagnostic test using CSF as a sample to support the diagnosis of neuroborreliosis.</p> answering member printed Earl Howe question first answered 24/07/2014 12:32:59 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77266

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what evidence existed to show that the Health Protection Agency’s Lyme Borreliosis Unit (LBU) conformed with European Union and United Kingdom legislation for the use of the Trinity Biotech kit for <i>in vitro</i> testing when used with cerebrospinal fluid; and what testing was carried out by the LBU to verify that the use of that test kit was suitable, and sufficiently sensitive, for the detection of European and United Kingdom species of Borrelia infections in cerebrospinal fluid.
tabling member printed	The Countess of Mar
uin	HL1000
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's Lyme Borreliosis Unit adhered to legislation related to diagnostic testing. The Trinity Biotech Lyme Western Blot technique was widely used in Europe at that time for serum and samples. Controls were run with each batch of the test to verify the tests accuracy and sensitivity. Quality assurance samples were run to ensure independent validation of the results.</p> answering member printed Earl Howe question first answered 24/07/2014 14:21:30 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar