Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent guidance he has issued to pregnant women on the effect of drinking alcohol during pregnancy.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The United Kingdom Chief Medical Officers’ Low Risk Drinking Guidelines published in August 2016 recommends that for women who are pregnant or planning to become pregnant, the safest approach is not to drink alcohol at all, to keep risks to a minimum. In March 2017, the Department issued guidance to industry setting out how the UK Chief Medical Officers’ low risk drinking guidelines could best be communicated on the labels of alcoholic drinks. This included specific advice on the communication of warnings not to drink alcohol during pregnancy. In light of the Chief Medical Officers’ guidance the National Health Service public facing website has updated their guidance and the Start4Life advice has also been updated. These can be viewed here at the following links:
https://www.nhs.uk/conditions/pregnancy-and-baby/alcohol-medicines-drugs-pregnant/
https://www.nhs.uk/start4life/pregnancy/alcohol/
Public Health England and NHS England as well as local commissioners are already undertaking awareness and education on the prevention agenda on the dangers of drinking any alcohol while pregnant such as through the Maternity Transformation Programme. The National Institute for Health and Care Excellence has also updated its guidelines ‘CG62 Antenatal care for uncomplicated pregnancies’ to reflect the Chief Medical Officers’ low risk guidelines that the safest approach is abstinence, and that where mothers are worried, they should seek advice from their midwife or general practitioner. This can be viewed at the following link:
https://www.gov.uk/government/publications/alcohol-consumption-advice-on-low-risk-drinking
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions his (a) Ministers and (b) officials have had with the (i) Medicines and Healthcare Regulatory Agency and (ii) members of the Expert Working Group on the review of hormone pregnancy tests (primodos) on why that Working Group changed the terms for that review from looking for an association to looking for a causal link as to the effect of the drugs concerned on the women it was given to.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency has a clearly defined, published policy on conflicts of interest for members of its scientific advisory committees and groups. This policy has been in place for a number of years and defines the level of participation of experts in the Commission on Human Medicines (CHM) and its Expert Groups.
Prior to being appointed to the CHM Expert Working Group (EWG) on Hormone Pregnancy Tests, all those invited to participate were required to complete and sign a declaration of interests form. At each meeting, experts were asked to declare any new interests. Experts with declared interests were precluded from participating in the EWG’s decision-making. Specific consideration was given to any concerns raised during the review and, in one case, led to one invited expert stepping down from the group before any scientific data were reviewed, even though the interest (a consultancy) had lapsed. All declared interests have been published.
In relation to the terms of reference of the EWG, an association between Hormone Pregnancy Tests and birth defects had long been the subject of debate, but the nature of any association remained uncertain. The EWG was formed specifically to review all the available evidence on the possible association between Hormone Pregnancy Tests during pregnancy and birth defects and reach a conclusion as to whether or not it supported a causal association. The terms of reference of the Expert Working Group on Hormone Pregnancy Tests defined the scope of the review, not the conclusion of the group, and did not change.
Asked by: Dan Carden (Labour - Liverpool, Walton)
Question to the Department for International Development:
To ask the Secretary of State for International Development, what steps her Department is taking to reduce maternal mortality.
Answered by Penny Mordaunt - Lord President of the Council and Leader of the House of Commons
Every year, the UK spends approximately £1 billion on reproductive, maternal, new-born and child health care.
The majority of maternal deaths are caused by complications during and following pregnancy and childbirth, such as severe bleeding, infections, complications from delivery and unsafe abortion. DFID works to reduce maternal mortality through a range of programmes, which focus on effective family planning, training health workers to manage obstetric emergencies and improving countries’ health systems to ensure health workers, drugs, equipment and transport are available when women and children need care.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, further to the Written Answers by Lord O’Shaughnessy on 15 November (HL11187 and HL11188), what data are recorded by the Medicines and Healthcare products Regulatory Agency’s pharmacovigilance work and the Yellow Card Scheme regarding drugs and dosages administered to women during IVF treatment and early pregnancy; to what extent this includes off-label drugs in order to monitor their long-term effects on women undergoing IVF treatment; how this compares to the collection of such data in other countries; and why the Human Fertilisation and Embryology Authority has no plans to establish a central database to monitor the long-term health implications of the medicines administered to women during IVF.
Answered by Lord O'Shaughnessy
The Medicines and Healthcare products Regulatory Agency (MHRA) continuously monitors all reports of suspected adverse drug reactions (ADRs) via the Yellow Card Scheme, including those reported in association with use for assisted reproduction such as in vitro fertilisation (IVF). These include reports of licensed and off-label use of medicines to suppress the natural menstrual cycle, medicines to prepare and stimulate the ovaries for ovulation, medicines at the time of egg collection and embryo transfer and medicines used to support the placenta during early pregnancy. The doses of each medicine used are set out in the product information of licensed medicines and are considered as part of the evaluation process when a potential safety concern is reviewed. A suspected ADR may be reported at any time after the medicine has been taken.
European Union legislation requires Member States to provide spontaneous reporting systems for ADRs to medicines. Such systems are widely used internationally for collection of suspected adverse reactions.
Data from the register of patients and treatments, maintained by the Human Fertilisation and Embryology Authority (HFEA), is already used for research on the long-term health implications of medicines administered during IVF. Among the research projects that have been conducted using HFEA register data are studies that looked at the cancer risk for women undergoing fertility treatment and children born as a result of assisted reproduction.
Asked by: Andrew Selous (Conservative - South West Bedfordshire)
Question to the Home Office:
To ask the Secretary of State for the Home Department, whether it is an aggravated offence for a pregnant women to use (a) cannabis, (b) ecstasy, (c) heroin and (d) other illegal or street drugs during pregnancy; and if he will make a statement.
Answered by Nick Hurd
There is no specific offence for drug use. It is an offence under the Misuse of Drugs Act 1971 for any person to possess a controlled drug. The penalty will depend on: the class and quantity of drug, where a person and the drugs were found, their personal history and other aggravating or mitigating factors.
The Government is determined to protect vulnerable women from drug misuse. Advice about alcohol and drugs is available to pregnant women as part of their routine antenatal care. Pregnant women who misuse alcohol or drugs will be put in contact with a midwife or doctor who has special expertise in the care of pregnant women with alcohol or drug problems. They will be able to refer them to an alcohol or drug treatment programme and other organisations that can help.
Asked by: Andrew Selous (Conservative - South West Bedfordshire)
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 effect of substance abuse by women during pregnancy on a child's health.
Answered by Steve Brine
No specific assessment has been made. However, using illegal or street drugs during pregnancy, including cannabis, ecstasy, cocaine and heroin, can have a potentially serious effect on an unborn baby and the advice is to avoid these substances.
Advice about alcohol and drugs is available to pregnant women as part of their routine antenatal care. Pregnant women who misuse alcohol or drugs will be put in contact with a midwife or doctor who has special expertise in the care of pregnant women with alcohol or drug problems. They will be able to refer them to an alcohol or drug treatment programme and other organisations that can help.
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, which NHS prescription drugs contain (a) Valproate and (b) Sodium Valproate or their derivatives; and what warnings are given to patients of the associated risks to pregnant women.
Answered by Jackie Doyle-Price
The name valproate is often used to describe several medicines used in the treatment of epilepsy and bipolar disorder – sodium valproate, semisodium valproate and valproic acid.
Sodium valproate is the active constituent of the following brands of prescription drugs authorised in the United Kingdom: Epilim, Episenta, Sodium valproate Zentiva, Convulex, Sodium valproate Ivax, Valprotek, Epival, Orlept, and Sodium valproate Teva.
Valproate semisodium is the constituent of Depakote tablets and Syonell gastro resistant tablets.
All formulations of valproate (sodium valproate, valproic acid and valproate semisodium) carry a risk of birth defects if taken by pregnant women and should only be used to treat women and girls of childbearing potential if other drugs are ineffective or not tolerated. Over the years the evidence of risk has grown and following a European review on the risks of developmental disorders, which completed in 2014, there has been extensive work to communicate clear advice to health professionals and patients. Warnings about the risks of valproate if taken during pregnancy and that females of childbearing age should use an effective method of contraception throughout treatment are included in a boxed warning in the package leaflet which accompanies the medicine. This leaflet also provides detailed information of the magnitude and nature of the risk, details of the actions patients need to take, where to find additional information and the importance of discussing this with their doctor.
Warnings are present on the outer packaging of the medicine and in a patient card which should be provided by the pharmacist when valproate is dispensed. Further information on the risks is provided in a patient guide to be used to support discussions between the woman and her doctor.
A further European review, initiated because of concerns about the effectiveness of measures taken to date, will complete shortly. It will deliver a strengthened regulatory position which will enable a more structured and systematic approach, through a pregnancy prevention programme, to ensure that women understand and accept the risks of treatment, are supported in making informed choices about contraception and that there is specialist supervision and monitoring if they chose to continue with valproate treatment.
Asked by: Alex Sobel (Labour (Co-op) - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to reduce the incidence of drink and drug abuse among pregnant women.
Answered by Steve Brine
The 2016 UK Chief Medical Officers’ low risk drinking guidelines provide the public with the most up to date scientific information to help people make informed decisions about their own drinking. The guidelines recommend that if you are pregnant or think you could become pregnant, the safest approach is not to drink alcohol at all to keep risks to the baby to a minimum. The guidelines are available at:
https://www.gov.uk/government/publications/alcohol-consumption-advice-on-low-risk-drinking
Advice about alcohol and drugs is available to pregnant women as part of their routine antenatal care. Pregnant women who misuse alcohol or drugs will be put in contact with a midwife or doctor who has special experience in the care of pregnant women with alcohol or drug problems. They will be able to refer them to an alcohol or drug treatment programme and other organisations that can help.
Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many children have been diagnosed with fetal anti-convulsant syndrome as a result of their mothers taking sodium valproate during pregnancy in each of the last three years.
Answered by Steve Brine
The information requested is not collected centrally. The actual number of children diagnosed with fetal anti-convulsant syndrome in the United Kingdom is very difficult to estimate from medical records. It is important to note that fetal anti-convulsant syndrome is a nondrug specific condition that relates to abnormalities in children exposed to any anticonvulsant during pregnancy, not just valproate.
Because of its risks, valproate should only be used to treat women of childbearing age if other drugs are ineffective or not tolerated. The Medicines and Healthcare products Regulatory Agency is currently working with European regulators and with experts and healthcare bodies to decide what further action should be taken to ensure valproate should only be used to treat women of childbearing age if other drugs are ineffective or not tolerated. This review is expected to complete early next year.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions (a) he, (b) Ministers and (c) officials of his Department have had with their counterparts in the EU regarding valproate.
Answered by Steve Brine
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.
The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.
France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).
Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.
The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.