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1694950

registered interest
date	11/03/2024
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help ensure adequate levels of supply of medications prescribed for epilepsy.
tabling member constituency	Wigan
tabling member printed	Lisa Nandy
uin	17833
answer	answer is ministerial correction date of answer 14/03/2024 answer text <p>There are around 14,000 medicines licensed for supply in the United Kingdom, and while most are in good supply, there can sometimes be supply issues with a limited number of medicines. The medicine supply chain is highly regulated, complex, and global. Supply disruption is an issue which affects the UK, as well as the other countries around the world.</p><p> </p><p>The Department has been working intensively to address issues with the supply of some epilepsy medications. Guidance has been issued to healthcare professionals on how to manage patients requiring affected medicines while supply is disrupted.</p><p> </p><p>We will continue to work closely with industry, the National Health Service, and others to help ensure patients continue to have access to an alternative treatment until their usual product is back in stock. The Department has been engaging with the Epilepsy Society, and we will continue to keep them updated on any developments.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 14/03/2024 10:07:08 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4082 label Biography information for Lisa Nandy

1236041

registered interest
date	21/09/2020
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether his Department plans to (a) reinstate the Quality Outcomes Framework for Epilepsy indicator relating to contraception, conception and pregnancy and (b) give women who are taking anti-epileptic drugs access to pre-conceptional counselling through the Pregnancy Prevention Programme.
tabling member constituency	Stalybridge and Hyde
tabling member printed	Jonathan Reynolds
uin	92767
answer	answer is ministerial correction date of answer 22/12/2020 answer text <p>The Quality Outcomes Framework (QoF) indicator which focused upon contraception, conception and pregnancy advice was retired in 2014 due to limitations with measurement.</p><p>In July 2018, NHS England and Improvement (NHSE/I) published the ‘Report of the Review of the Quality and Outcomes Framework in England.’ This identified a number of principles for the reform of QoF which NHS E/I are continuing to implement, including a focus upon quality improvement activities in areas where metric development is challenging, and upon an increased personalisation of care. The report is available via the link below:</p><p><a href="https://www.england.nhs.uk/publication/report-of-the-review-of-the-quality-and-outcomes-framework-in-england/" target="_blank">https://www.england.nhs.uk/publication/report-of-the-review-of-the-quality-and-outcomes-framework-in-england/</a></p><p>NHS E/I continue to keep the QoF epilepsy domain under review, and are exploring the potential for new indicators to be developed and implemented.</p><p>Every pregnant woman taking the anti-epilepsy drug valproate must be enrolled in the statutory Pregnancy Prevention Programme, and every healthcare professional involved in the prescribing and dispensing of valproate (so for example GPs and pharmacists) must ensure women are aware of the serious risks to pregnancy valproate presents.</p><p>Following advice from the Commission on Human Medicines, the available data relating to safety of use of non-valproate epileptic medicines during pregnancy is currently being evaluated. As part of this review, the product information for prescribers and patients will be evaluated to ensure that it is clear and up to date, including the need for preconception counselling, as appropriate. The communications from this review will be made publicly available in order to support informed decision making about the most appropriate choice of antiepileptic treatment in the individual case.</p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 22/12/2020 10:29:06 answering member 4380 label Biography information for Jo Churchill
tabling member	4119 label Biography information for Jonathan Reynolds

1216766

registered interest
date	23/06/2020
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure the continued supply of epilepsy medication in the event that the UK exits the transition period without a trade agreement with the EU.
tabling member constituency	Bristol West
tabling member printed	Thangam Debbonaire
uin	63371
answer	answer is ministerial correction date of answer 08/07/2020 answer text <p>The United Kingdom left the European Union on 31 January and is now in a Transition Period until 31 December 2020. During this time, it remains our objective to negotiate a future relationship with the EU and in our respective published negotiating documents, we have both stated objectives to reach an agreement on trade in goods. The UK’s published approach sets out how we want to facilitate trade in medicinal products and support high levels of patient safety.</p><p>The Department has well-established procedures to deal with medicine shortages, whatever their cause, and will always work closely with the pharmaceutical industry and National Health Service to help ensure patients continue to have access to the medicines and treatments they need, including epilepsy medication, under all scenarios.</p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 08/07/2020 16:22:09 answering member 4380 label Biography information for Jo Churchill
tabling member	4433 label Biography information for Thangam Debbonaire

1171845

registered interest
date	20/01/2020
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, for what reasons epilepsy is allocated one point in the General Medical Services Statement of Financial Entitlements (Amendment) Directions 2019; and what steps GPs take to ensure that women of child bearing age who are prescribed Valporate are enrolled in a pregnancy prevention programme.
tabling member constituency	Lancaster and Fleetwood
tabling member printed	Cat Smith
uin	5459
answer	answer is ministerial correction date of answer 23/01/2020 answer text <p>Changes to the Quality and Outcomes Framework (QOF)- including allocation of points- are agreed as part of wider amendments to the General Medical Services (GMS) Contract. These changes are negotiated by NHS England and the British Medical Association’s (BMA) General Practitioners Committee England. Guidance on the 2019/20 GMS Contract concerning the QOF was published by the BMA and NHS England in April 2019. This guidance includes an epilepsy indicator which states that ‘the contractor establishes and maintains a register of patients aged 18 or over receiving drug treatment for epilepsy’. QOF points are generally weighted to the estimated workload associated with an indicator. Registers generally incur a lower workload than other indicators and therefore tend to attract a lower points value than other types of indicators.</p><p> </p><p>Care of patients with long term conditions in general practice is described in the essential services element of the contract and funded through the global sum payment. Patients should expect to receive high quality care irrespective of whether or not their condition is included in the QOF. The QOF indicators will continued to be reviewed going forward.</p><p> </p><p>It is a Care Quality Commission regulatory requirement for general practitioners (GPs) to follow the Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on valproate prescribing. The MHRA advises that ‘Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place’.</p><p> </p><p>NHS England are also taking broader action to support implementation of the MHRA pregnancy prevention guidelines. In April 2019, they introduced a new Quality Improvement module on prescribing safety into the QOF. As part of this module they expect practices to audit three measures, one of which is that girls and women of childbearing potential currently being prescribed valproate have had an annual specialist medication review and are taking this in compliance with the pregnancy prevention programme as documented by a specialist in the annual risk acknowledgement form. It is the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure women are aware of the risks and are on the pregnancy prevention programme.</p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill grouped question UIN 5460 question first answered 23/01/2020 17:19:31 answering member 4380 label Biography information for Jo Churchill
tabling member	4436 label Biography information for Cat Smith

1171846

registered interest
date	20/01/2020
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, for what reasons no points have been allocated to ongoing management for epilepsy medication in the General Medical Services contract Quality and Outcomes Framework.
tabling member constituency	Lancaster and Fleetwood
tabling member printed	Cat Smith
uin	5460
answer	answer is ministerial correction date of answer 23/01/2020 answer text <p>Changes to the Quality and Outcomes Framework (QOF)- including allocation of points- are agreed as part of wider amendments to the General Medical Services (GMS) Contract. These changes are negotiated by NHS England and the British Medical Association’s (BMA) General Practitioners Committee England. Guidance on the 2019/20 GMS Contract concerning the QOF was published by the BMA and NHS England in April 2019. This guidance includes an epilepsy indicator which states that ‘the contractor establishes and maintains a register of patients aged 18 or over receiving drug treatment for epilepsy’. QOF points are generally weighted to the estimated workload associated with an indicator. Registers generally incur a lower workload than other indicators and therefore tend to attract a lower points value than other types of indicators.</p><p> </p><p>Care of patients with long term conditions in general practice is described in the essential services element of the contract and funded through the global sum payment. Patients should expect to receive high quality care irrespective of whether or not their condition is included in the QOF. The QOF indicators will continued to be reviewed going forward.</p><p> </p><p>It is a Care Quality Commission regulatory requirement for general practitioners (GPs) to follow the Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on valproate prescribing. The MHRA advises that ‘Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place’.</p><p> </p><p>NHS England are also taking broader action to support implementation of the MHRA pregnancy prevention guidelines. In April 2019, they introduced a new Quality Improvement module on prescribing safety into the QOF. As part of this module they expect practices to audit three measures, one of which is that girls and women of childbearing potential currently being prescribed valproate have had an annual specialist medication review and are taking this in compliance with the pregnancy prevention programme as documented by a specialist in the annual risk acknowledgement form. It is the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure women are aware of the risks and are on the pregnancy prevention programme.</p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill grouped question UIN 5459 question first answered 23/01/2020 17:19:31 answering member 4380 label Biography information for Jo Churchill
tabling member	4436 label Biography information for Cat Smith

1150408

registered interest
date	17/10/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps his Department has taken to ensure people living in the London Borough of Southwark with epilepsy can continue to get the medication they need in the event of the UK leaving the EU without a deal.
tabling member constituency	Camberwell and Peckham
tabling member printed	Ms Harriet Harman
uin	1533
answer	answer is ministerial correction date of answer 22/10/2019 answer text <p>The Department is doing everything appropriate to prepare for leaving the European Union. We want to reassure patients throughout the United Kingdom that our plans should ensure the uninterrupted supply of medicines and medical products, including those for use in the treatment of epilepsy, once we have left the EU.</p><p>The Department, as part of our EU exit preparations, is implementing a multi-layered approach to mitigate potential disruption to supply, which consists of stockpiling where possible, securing freight capacity, changing or clarifying regulatory requirements, procuring additional warehousing, working closely with industry to improve trader readiness and putting in place the National Supply Disruption Response to manage potential shortages. Further details can be found at the following link:</p><p><a href="https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans" target="_blank">https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans</a></p><p>We have been working closely with suppliers to monitor over 300 different epilepsy medicines provided by almost 50 companies and we are pleased to see many are holding stockpiles far beyond the six weeks’ additional buffer we requested. We also know that the vast majority of those suppliers with lower levels of stockpiles have already taken action to re-route their supply chains away from the Channel short straits crossings where applicable.</p><p> </p><p>The Department, alongside NHS England and NHS Improvement, is ensuring that there is regular communication with frontline NHS organisations and stakeholders in the health and social care sector regarding our EU exit preparations. NHS England and NHS Improvement have also been holding EU exit roadshows in the lead up to 31 October.</p> answering member constituency Charnwood answering member printed Edward Argar question first answered 22/10/2019 11:18:05 answering member 4362 label Biography information for Edward Argar
tabling member	150 label Biography information for Ms Harriet Harman

1149333

registered interest
date	15/10/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether anti-epileptic drugs are exempted from serious shortage protocols; and what assessment he has made of the potential effect of the use of such protocols on (a) people with learning disabilities and (b) their families in the event that the UK leaves the EU without a withdrawal agreement.
tabling member constituency	North Norfolk
tabling member printed	Norman Lamb
uin	475
answer	answer is ministerial correction date of answer 21/10/2019 answer text <p>While Serious Shortage Protocols (SSP) in England have the scope to cover all medicines and appliances that are on a National Health Service prescription in primary care, including anti-epileptic drugs, it is clear that an SSP for therapeutic or generic equivalents will not necessarily be suitable for all medicines and patients. For example, where medicines need to be prescribed by brand for clinical reasons, which is the case for epilepsy medication.</p><p>Any protocol would only be introduced if clinicians with expertise in the relevant area think it is appropriate. Pharmacists will have to use their professional judgment as to whether supplying against the protocol rather than the prescription is appropriate or the patient should be referred to their prescriber.</p><p>The legislation enabling Ministers to issue SSPs was not introduced as a European Union exit measure alone but as a business-as-usual measure that can be used before and after our exit from the EU.</p> answering member constituency Charnwood answering member printed Edward Argar question first answered 21/10/2019 13:07:33 answering member 4362 label Biography information for Edward Argar
tabling member	1439 label Biography information for Norman Lamb

1149339

registered interest
date	15/10/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the adequacy of the availability of anti-epilepsy medications in the event that the UK leaves the EU without a deal.
tabling member constituency	North Norfolk
tabling member printed	Norman Lamb
uin	479
answer	answer is ministerial correction date of answer 21/10/2019 answer text <p>The Department is doing everything appropriate to prepare for leaving the European Union. We want to reassure patients that our plans should ensure the uninterrupted supply of medicines and medical products, including those used for the treatment of epilepsy, once we have left the EU.</p><p>The Department, as part of our EU exit preparations, is implementing a multi-layered approach to mitigate potential disruption to supply, which consists of stockpiling where possible, securing freight capacity, changing or clarifying regulatory requirements, procuring additional warehousing, working closely with industry to improve trader readiness and putting in place the National Supply Disruption Response to manage potential shortages. Further details can be found at the following link:</p><p><a href="https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans" target="_blank">https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans</a></p><p>We have been working closely with suppliers to monitor over 300 different epilepsy medicines provided by almost 50 companies and we are pleased to see many are holding stockpiles far beyond the six weeks’ additional buffer we requested. We also know that the vast majority of those suppliers with lower levels of stockpiles are taking action to re-route their supply chains away from the short straits crossings where applicable.</p><p> </p><p> </p> answering member constituency Charnwood answering member printed Edward Argar question first answered 21/10/2019 13:04:06 answering member 4362 label Biography information for Edward Argar
tabling member	1439 label Biography information for Norman Lamb

1145541

registered interest
date	24/09/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the UK leaving the EU without a deal on access to epilepsy medication.
tabling member constituency	Dulwich and West Norwood
tabling member printed	Helen Hayes
uin	290454
answer	answer is ministerial correction date of answer 30/09/2019 answer text <p>The Department is doing everything appropriate to prepare for the United Kingdom’s exit from the European Union. Our plans should ensure the supply of medicines and medical products when we leave the EU on 31 October.</p><p>The Department, in consultation with the devolved administrations, has been working with trade bodies, product suppliers, and the health and care system in England to make detailed plans that should ensure continuation of the supply of medicines, to the whole of the UK and its Crown Dependencies.</p><p> </p><p>On 26 June, we wrote to suppliers of medicines to the UK from or via the EU or European Economic Area setting out our continuing multi-layered approach to support continuity of supply of medicines and medical products from 31 October.</p><p>Further details can be found at the following link:</p><p><a href="https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans" target="_blank">https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans</a></p><p> </p> answering member constituency Charnwood answering member printed Edward Argar question first answered 30/09/2019 16:50:47 answering member 4362 label Biography information for Edward Argar
tabling member	4510 label Biography information for Helen Hayes

1132912

registered interest
date	18/06/2019
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Epilepsy: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what recent discussions he has had with the Royal College of Nursing on monitoring the level of suicides among people who take antiepileptic drugs.
tabling member constituency	Strangford
tabling member printed	Jim Shannon
uin	266212
answer	answer is ministerial correction date of answer 26/06/2019 answer text <p>We have had no such discussions. As with all medicines, the safety of antiepileptic drugs remains under constant review by the Medicines and Healthcare products Regulatory Agency.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 26/06/2019 16:23:55 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4131 label Biography information for Jim Shannon