Parliamentary Written Questions

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As part of the ongoing work of the APPG the following Written Questions was submitted to the Department of Health on behalf of our APPG member Andrew Gwynne MP.

1) To ask the Secretary of State for Health, what steps his Department is taking through the Medicines and Healthcare Products Regulatory Agency to ensure that all women of child-bearing age who are prescribed Valproate have received the new guidance on the use of that treatment.

Answer :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. When it was authorised, valproate was known to have risks in pregnancy. The statutory Patient Information Leaflet which accompanies the medicine provides up-to-date detailed information on the risks of valproate in pregnancy. 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 and a checklist for prescribers; a reminder card to be provided by pharmacists to patients when the product is dispensed; a guide for women; and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated to relevant healthcare professionals from February 2016 including through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service), the MHRA’s Drug Safety Update bulletin and in hard copy from the marketing authorisation holders. Electronic copies of the toolkit are hosted on several websites, including the Electronic Medicines Compendium.
In addition the MHRA has worked, and continues to work with, a coalition of stakeholders including Royal Colleges, professional bodies, patient groups, relevant charities and health system organisations, including clinical commissioning groups, to increase awareness of the toolkit among general practitioners, pharmacists and patients, through a variety of communication channels.
In order to monitor the effectiveness of the valproate toolkit, the MHRA continues to work with all stakeholders to gather feedback that demonstrates the toolkit materials are being used. This includes working with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, the MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and the awareness of healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
All doctors are expected to comply with good practice set out in General Medical Council (GMC) guidance. The GMC prescribing guidance states that doctors should reach agreement with the patient on the treatment proposed, explaining the likely benefits, risks and burdens, including serious and common side effects. Doctors should report any adverse reactions to medicines through the Yellow Card Scheme.

2) To ask the Secretary of State for Health, whether GPs are required to (a) record and (b) report each instance when they have warned a female patient of the dangers of prescribed Valproate.

Answer : 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. When it was authorised, valproate was known to have risks in pregnancy. The statutory Patient Information Leaflet which accompanies the medicine provides up-to-date detailed information on the risks of valproate in pregnancy. 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 and a checklist for prescribers; a reminder card to be provided by pharmacists to patients when the product is dispensed; a guide for women; and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated to relevant healthcare professionals from February 2016 including through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service), the MHRA’s Drug Safety Update bulletin and in hard copy from the marketing authorisation holders. Electronic copies of the toolkit are hosted on several websites, including the Electronic Medicines Compendium.
In addition the MHRA has worked, and continues to work with, a coalition of stakeholders including Royal Colleges, professional bodies, patient groups, relevant charities and health system organisations, including clinical commissioning groups, to increase awareness of the toolkit among general practitioners, pharmacists and patients, through a variety of communication channels.
In order to monitor the effectiveness of the valproate toolkit, the MHRA continues to work with all stakeholders to gather feedback that demonstrates the toolkit materials are being used. This includes working with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, the MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and the awareness of healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
All doctors are expected to comply with good practice set out in General Medical Council (GMC) guidance. The GMC prescribing guidance states that doctors should reach agreement with the patient on the treatment proposed, explaining the likely benefits, risks and burdens, including serious and common side effects. Doctors should report any adverse reactions to medicines through the Yellow Card Scheme.

3) To ask the Secretary of State for Health, how (a) his Department and (b) the Medicines and Healthcare Products Regulatory Agency will be alerted when all concerned women have been warned of the dangers of prescribed Valproate.

Answer : 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. When it was authorised, valproate was known to have risks in pregnancy. The statutory Patient Information Leaflet which accompanies the medicine provides up-to-date detailed information on the risks of valproate in pregnancy. 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 and a checklist for prescribers; a reminder card to be provided by pharmacists to patients when the product is dispensed; a guide for women; and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated to relevant healthcare professionals from February 2016 including through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service), the MHRA’s Drug Safety Update bulletin and in hard copy from the marketing authorisation holders. Electronic copies of the toolkit are hosted on several websites, including the Electronic Medicines Compendium.
In addition the MHRA has worked, and continues to work with, a coalition of stakeholders including Royal Colleges, professional bodies, patient groups, relevant charities and health system organisations, including clinical commissioning groups, to increase awareness of the toolkit among general practitioners, pharmacists and patients, through a variety of communication channels.
In order to monitor the effectiveness of the valproate toolkit, the MHRA continues to work with all stakeholders to gather feedback that demonstrates the toolkit materials are being used. This includes working with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, the MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and the awareness of healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
All doctors are expected to comply with good practice set out in General Medical Council (GMC) guidance. The GMC prescribing guidance states that doctors should reach agreement with the patient on the treatment proposed, explaining the likely benefits, risks and burdens, including serious and common side effects. Doctors should report any adverse reactions to medicines through the Yellow Card Scheme.

Pregnant women with epilepsy ‘need specialist care’

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Pregnant women with epilepsy should be treated by a specialist healthcare team to prevent unnecessary deaths, according to new national guidelines.

Produced by the Royal College of Obstetricians and Gynaecologists, the guidelines recommend women seek advice well before pregnancy on their care.
Managing seizure control, tiredness and risks linked to some epilepsy medicines can make pregnancy a difficult time.

Around 2,500 infants are estimated to be born to women with epilepsy every year in the UK.
Early advice

But there are risks to the health of unborn babies from taking some anti-epileptic drugs during pregnancy, particularly sodium valproate.
EPILIM
Some women stop taking their medication or cut down, which can make seizures worse and increase the risk of harm to mother and baby.
However, the guidance says “most mothers have normal healthy babies”, but women with epilepsy should be informed that the risk to the foetus is dependent on the type, number and doses of drug they take.
These RCOG guidelines, for GPs, midwives, consultants and women with the condition, say women should:
seek advice from their GP before conception
be given the lowest effective dose of the most appropriate epilepsy medication
take a higher dose of folic acid to reduce the risk of spinal defects in their baby
give birth in a consultant-led unit if at risk of seizures during labour
receive support after the birth to minimise the risk of seizures from exhaustion and stress

What is epilepsy?
It’s a condition that affects the brain, leading to epileptic seizures.
A seizure happens when there is a sudden burst of intense electrical activity in the brain. This causes a temporary disruption to the way the brain normally works.
There are many different types of seizure. During the more serious ones, the person can lose awareness, go stiff, fall to the floor and the body can jerk.
Some types of epilepsy last for a limited time and the person eventually stops having seizures. But for many people epilepsy is a life-long condition.

Shakila Thangaratinam, lead author of the guidelines and professor of maternal and perinatal health at Barts and the London School of Medicine and Dentistry, said the right care before, during and after pregnancy was important.
“Women with epilepsy require multi-disciplinary care throughout their pregnancy, and healthcare professionals need to be aware of the small but significant increase in risks.
“While most women who have epilepsy remain free of seizures throughout their pregnancy, some may have more seizures if they are pregnant.
“It is important that these women receive pre-conception counselling, meet with an epilepsy specialist, and are monitored closely for seizure risk factors.”

Close monitoring

Louise Silverton, director for midwifery at the Royal College of Midwives, also welcomed the guidance.
“It is vital we remember that women with epilepsy are classified as high risk during their pregnancy, often they require more monitoring and specialist care during the course of their pregnancy. However, the majority of women with epilepsy will give birth safely.”
Experts say the risk of death is 10 times greater in pregnant women with epilepsy compared with those without the condition.
Between 2009 and 2013, 21 women died during pregnancy as a result of epilepsy – and in most of those cases their seizures were found to be poorly controlled.