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785879

registered interest
date	07/11/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Drugs: Side Effects
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 2 November (HL2355), what are the internationally understood definitions of (1) "suspected adverse event", and (2)"‘serious adverse event", following the administration of a drug.
tabling member printed	The Countess of Mar
uin	HL3027
answer	answer is ministerial correction date of answer 20/11/2017 answer text <p>My previous answer of 2 November referred specifically to reports from clinical trials. In the context of clinical trials, an adverse event (AE) is defined as: ‘Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.’ A serious adverse event (SAE) is defined as: ‘Any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect’.</p><p> </p><p>The term ‘suspected’ is not used in the context of AEs and SAEs.</p><p> </p><p>The definition of an adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended. Through the Yellow Card Scheme, the Medicines and Healthcare products Regulatory Agency encourages anyone to report a suspected ADR. For suspected ADRs, there is not necessarily a causal relationship with the medicine, but a suspicion by the reporter that the medicine may have been responsible. Suspected ADRs are continuously reviewed to detect possible new risks.</p> answering member printed Lord O'Shaughnessy question first answered 20/11/2017 12:23:22 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

785880

registered interest
date	07/11/2017
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, further to the Written Answer by Lord O'Shaughnessy on 2 November (HL2355), what are the latest figures for (1) suspected adverse events, and (2) serious adverse events, relating to (a) Gardasil, and (b) Cevarix, since those vaccines were introduced; and how many of those who reported serious adverse events remain incapacitated.
tabling member printed	The Countess of Mar
uin	HL3028
answer	answer is ministerial correction date of answer 20/11/2017 answer text <p>Through the Yellow Card Scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) has received 9,007 reports of suspected adverse reactions (ADRs) to human papillomavirus (HPV) vaccine, up to the 6 November 2017. This follows administration of more than nine million doses of HPV vaccine in the United Kingdom. A breakdown by brand and severity is provided in the table below.</p><p> </p><table><tbody><tr><td><p> </p></td><td><p>Total</p></td><td><p>Serious</p></td></tr><tr><td><p>HPV brand unspecified</p></td><td><p>691</p></td><td><p>485</p></td></tr><tr><td><p>Cervarix</p></td><td><p>6,323</p></td><td><p>1,822</p></td></tr><tr><td><p>Gardasil</p></td><td><p>1,961</p></td><td><p>842</p></td></tr><tr><td><p>Gardasil 9</p></td><td><p>37</p></td><td><p>18</p></td></tr><tr><td><p>Total</p></td><td><p>9,007</p></td><td><p>3,162</p></td></tr></tbody></table><p><em>Source</em>: MHRA Sentinel database for ADRs.</p><p>It should be noted that the total number of reports received by vaccine brand is not equal to the totals in the table above, as some reports included more than one HPV vaccine brand.</p><p> </p><p>Each report may contain more than one symptom. Of the serious reports, 25% include a symptom that is recorded as not recovered. This is based on the information available on outcome at the time of reporting and cannot be used to determine the number of patients with persistent symptoms. While the MHRA encourages reporters to update the outcome, this is not always provided.</p><p> </p> answering member printed Lord O'Shaughnessy question first answered 20/11/2017 12:30:55 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

784727

registered interest
date	06/11/2017
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, in the light of the BMJ best practice guidance on chronic fatigue syndrome published in July, whether there are any National Health Service tests available for autoimmune and metabolic dysfunction.
tabling member printed	The Countess of Mar
uin	HL2945
answer	answer is ministerial correction date of answer 20/11/2017 answer text <p>Clinical commissioning groups (CCGs) are responsible for commissioning many healthcare services to meet the needs and requirements of their local population, including those for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In doing so, CCGs will commission services that reflect the needs of local people and that support improvements in health and healthcare outcomes.</p><p> </p><p>The current National Institute for Health and Care Excellence (NICE) guidance on ME/CFS does not recommend routine autoimmune or metabolic testing but advises that diagnosis should be made after all other possible diagnoses have been excluded. Shared decision making should take place during diagnosis and all phases of care between the person with ME/CFS and healthcare professionals.</p><p> </p><p>On 20 September 2017, NICE announced plans to undertake a full review of the guidance.</p> answering member printed Lord O'Shaughnessy question first answered 20/11/2017 12:15:54 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

784728

registered interest
date	06/11/2017
answering body	Department for Digital, Culture, Media and Sport
answering dept id	10
answering dept short name	Digital, Culture, Media and Sport
answering dept sort name	Digital, Culture, Media and Sport
hansard heading	Advertising Standards Authority
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether the Advertising Standards Authority (ASA) Compliance Team reports to complainants or publishes details of its work in the case of further complaints following investigation and upholding by the ASA of the original complaint; and if not, why not.
tabling member printed	The Countess of Mar
uin	HL2946
answer	answer is ministerial correction date of answer 20/11/2017 answer text <p>The Advertising Standards Authority (ASA) is the UK's regulator of advertising. This regulatory system is independent of government and seeks to ensure that all adverts, wherever they appear, are legal, decent, honest and truthful. All ASA adjudications are published however given their independence from government we are not able to comment on the ASA's internal processes.</p> answering member printed Lord Ashton of Hyde question first answered 20/11/2017 17:45:27 answering member 4247 label Biography information for Lord Ashton of Hyde
tabling member	1861 label Biography information for The Countess of Mar