Asked by: Valerie Vaz (Labour - Walsall and Bloxwich)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that clinicians are discussing with women and girls the risks of taking sodium valproate and other anti-epileptic drugs (AEDs) during pregnancy.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that documents forming the basis of the valproate Pregnancy Prevention Programme are available electronically and distributed regularly as hard copies to prescribers and pharmacists to support discussions of the risks of taking sodium valproate during pregnancy with women and girls who require this medicine. Healthcare professionals have been reminded of their responsibility to inform women and girls taking valproate of the risks, through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update. The conclusions of a safety review by the Commission of Human Medicines of the risks of other epilepsy medicines in pregnancy have recently been published to aid discussions about the most suitable treatment options.
The MHRA is working with the wider healthcare network to explore additional ways of improving the reach of regulatory communications through platforms in the healthcare and patient setting. The MHRA is working to establish a registry to monitor the use of valproate in women and girls and clinician and patient compliance with the current regulatory position.
Asked by: Valerie Vaz (Labour - Walsall and Bloxwich)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Commission on Human Medicines' review of the use of epilepsy medicines in pregnancy, published on 7 January 2021, whether the provisions of the Pregnancy Prevention Programme will be extended to include any other anti-epileptic drugs identified in posing a risk.
Answered by Nadine Dorries
The Commission on Human Medicines’ review concluded that lamotrigine and levetiracetam are safer to use during pregnancy than other epilepsy medicines and that some of the other reviewed antiepileptic drugs may also be associated with harms to the child. Where the data support evidence of harm, neither the magnitude nor the nature of the risks observed with the reviewed epilepsy medicines are as severe as that associated with the use of valproate during pregnancy. A Pregnancy Prevention Programme therefore has not been recommended for any of the other reviewed epilepsy medicines at this time.
Asked by: Jonathan Reynolds (Labour (Co-op) - Stalybridge and Hyde)
Question to the Department of Health and Social Care:
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.
Answered by Jo Churchill
The Quality Outcomes Framework (QoF) indicator which focused upon contraception, conception and pregnancy advice was retired in 2014 due to limitations with measurement.
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:
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.
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.
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.
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
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
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 Wyre)
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.