Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications for his policies of levels of disability in children of men who have been prescribed sodium valporate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Valproate is recognised to be associated with risks to children which can be disabling, when women take valproate during pregnancy and there are measures in place to ensure women are aware of the risks and the importance of using contraception while taking valproate to minimise the risk of a pregnancy being exposed to valproate.
There are concerns that children of men who have been prescribed valproate may also be at risk. A recent study was supplied to regulatory authorities across Europe including the United Kingdom’s Medicines and Healthcare products Regulatory Agency which suggested an increased risk of neurodevelopmental disorders in children when fathers took valproate. Unfortunately, errors were identified in the study that require reanalysis before conclusions can be drawn, and more information on this is available at the following link:
Once this reanalysis has been completed the necessary regulatory action will be taken and information provided to healthcare professionals and patients. However, it is worth noting that the initial data did not suggest a risk of major congenital malformations and the risk of neurodevelopmental disorders was much lower than observed in studies when women take valproate during pregnancy.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will make an assessment of the potential merits of reviewing prescribing guidelines for sodium valproate to help ensure that babies of men and women do not experience disability due to that medication.
Answered by Will Quince
The National Institute for Health and Care Excellence (NICE) is the independent, expert body responsible for developing authoritative, evidence-based guidance for the National Health Service on best practice. NICE will consider any amendments to its existing recommendations on the use of sodium valproate in the light of any changes to the medicine’s regulatory status.
In August 2023, NICE added a note to its guidance stating “The Medicines and Healthcare products Regulatory Agency (MHRA) issued new safety advice on risks associated with valproate for the under 55s in December 2022. NICE states that the valproate recommendations in this guideline will be reviewed once further advice from the MHRA is available. People currently taking valproate should not stop taking it unless they are advised by a specialist to do so”.
Asked by: Alan Brown (Scottish National Party - Kilmarnock and Loudoun)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the proposed timescales are for the Patient Safety Commissioner review on sodium valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Patient Safety Commissioner is expected to publish a report of her current work examining options for redress for those harmed by sodium valproate and pelvic mesh in early 2024. Ministers will consider the report’s findings before deciding how to proceed on this matter.
Asked by: Charlotte Nichols (Labour - Warrington North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare Products Regulatory Agency is taking steps to investigate the potential effect of valproate on men and their fertility.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Valproate is a medicine authorised for the treatment of epilepsy and bipolar disorder. The product information for all medicines is approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The product information for valproate containing medicines has listed male infertility as a possible side effect since 2011.
In 2021, the MHRA reviewed the totality of data on the risk of male infertility associated with valproate including evidence for reversibility of effects. Although the data are limited, the valproate product information was updated in 2021 to advise that male infertility is usually reversible after treatment discontinuation and may be reversible after dose reduction. However, in some cases, the reversibility of male infertility was unknown.
The underlying biological mechanism is currently uncertain, but animal data on valproate show toxicity to testicular tissue structure and function. MHRA keeps all data under review and is investigating the clinical relevance of these data with the marketing authorisation holders.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will make an assessment of the potential impact of (a) automated dispensing technology, (b) digital consultations and (c) other digital technologies on levels of efficiency in the pharmacy sector.
Answered by Neil O'Brien
Between 16 March and 8 June 2022, the Government ran a consultation on proposals to enable all pharmacies to be able to access external hub dispensing services facilitating greater use of automation. An impact assessment which takes into consideration the role of automated dispensing technology in the hub and spoke model was completed as part of this work. The impact assessment is available at the following link:
There will be synergistic efficiencies gained by using hub and spoke dispensing and original pack dispensing (OPD) supporting the highly automated processes that hubs are likely to employ. Between 1 November and 13 December 2021, the Government consulted on proposals to enable OPD. The consultation response is available at the following link:
The Delivery plan for recovering access to primary care, published on 9 May, commits to significantly improving the digital infrastructure between general practice and community pharmacy by introducing interoperable digital solutions to support secure communications between general practice and community pharmacies. There are no plans to make an assessment of the potential impact of digital consultations and other digital technologies on levels of efficiency.
Asked by: Alan Brown (Scottish National Party - Kilmarnock and Loudoun)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 5 May 2023 to Question 183124 on Pregnancy: Sodium Valproate, how many sodium valproate victims there have been in England.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The information requested is not collected centrally. Limitations to historical data recording and collation mean that the total number of children diagnosed with congenital malformations or neurodevelopmental disorders following exposure to sodium valproate in utero in England or across the United Kingdom since its authorisation is very difficult to estimate.
Asked by: Alan Brown (Scottish National Party - Kilmarnock and Loudoun)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many sodium valproate victims there are in Scotland.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The information requested is not collected centrally.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the timeframe is for the Patient Safety Commissioner for Valproate producing the lifetime costings of caring for a disabled child affected by sodium valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Our sympathies remain with all those affected by the side effects of sodium valproate.
The Department has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work on redress for people harmed by sodium valproate and pelvic mesh. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take. The work is expected to take around four months and the Patient Safety Commissioner will publish a report setting out the findings from this work. Once finalised, Ministers will consider the report’s findings before deciding how to proceed on this matter.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what progress he has made on discussions with the Patient Safety Commissioner on the costings for compensation for people who have been harmed by Valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Our sympathies remain with all those affected by the side effects of sodium valproate. Patient safety is a priority, and we are taking a range of action to improve the future safety of medicines and medical devices, setting high standards for industry to market and manufacture products, with the aim of reducing harm in the future.
The Department has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work on redress for people harmed by sodium valproate and pelvic mesh.
The Patient Safety Commissioner will publish a report setting out the findings from this work. Once finalised, Ministers will consider the report’s findings before deciding how to proceed on this matter.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question
To ask the Minister for Women and Equalities, what steps the Government is taking to support women with epilepsy to make informed family planning choices and have safe pregnancies.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Tighter restrictions continue to reduce the number of pregnancies exposed to sodium valproate and support women to make informed choices. The MHRA and Commission on Human Medicines (CHM) has announced it will introduce tighter restrictions to reduce pregnancies exposed to sodium valproate, including the recommendation for no new patients under 55 years of age to be prescribed valproate unless two specialists independently consider and document that no other medicine is effective or tolerated.