Results of our valproate survey

Background

In 2017 Epilepsy Action, Epilepsy Society and Young Epilepsy conducted a survey of women and girls with epilepsy who take valproate as a medicine, and their parents and carers. The results showed that 1 in 5 (18%) women taking valproate were unaware that taking it during pregnancy can harm an unborn baby.

On 24 April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) changed the licence for valproate medicines in the UK. Valproate must no longer be prescribed to women or girls who are able to become pregnant unless they are on the Pregnancy Prevention Programme (PPP).

As part of the PPP, the prescriber must make sure the woman or girl understands the risk if she became pregnant while taking the medicine. The MHRA have produced materials to support healthcare professionals informing women on valproate of the risks in pregnancy. These include: a ‘Prevent: valproate pregnancy prevention’ card about use of valproate and pregnancy which should be given out with a prescription of valproate; a booklet, Prevent: A Patient Guide for healthcare professionals to give to patients; and a patient information leaflet (PIL) which should be provided with any medicine containing valproate.

Women must also be aware of the need to take contraception while on valproate. A risk acknowledgement form must be completed and signed during a review, which must take place at least once a year.

Between October 2019 and January 2020, Epilepsy Action worked with Epilepsy Society and Young Epilepsy to conduct another survey of women who have taken or who are taking valproate, since the introduction of the PPP. We surveyed women and girls who have taken valproate since 1 August 2018, and who therefore should have seen a health professional in that time.

The report below explains the findings of the survey, based on the 751 responses we received. Of these, 519 were taking valproate at the time of the survey and 51 had been prescribed it in the past but stopped after 1 August 2018. 56 respondents were parents or carers of girls under 13 years old. These responses have not been included in the results below as this age group is subject to different prescribing guidelines.

The survey results reported below are based on the responses of these 514 respondents.

• The results in England were in line with the overall numbers for the UK.
• It must be noted that the numbers reported for Wales (47), Scotland (57) and Northern Ireland (37) are low and so must be treated with caution.
• Looking at regional data Wales is performing better than other areas with regards to making sure women are aware of the risks of both physical birth defects and learning and development problems.
• Women in Wales stated that they are more aware of the risks of birth defects and learning difficulties, (93% and 86% compared to 89% and 82% nationally). Women in Wales are also much more likely to have been asked to sign the Annual Risk Acknowledgement Form. 61% of respondents in Wales stated that they had been asked to sign, compared to 41% nationally (in Northern Ireland only 23% had been asked to sign, and 33% in Scotland).
• Women in Northern Ireland were more likely to have not received information about Prevent (69% of women in Northern Ireland had received a patient information leaflet, 27% received a prevent card, and 35% received a prevent booklet).
• Women in Northern Ireland were less likely to have received advice about the risks of taking valproate from a healthcare professional. Only 50% had such a discussion with their GP (75% nationally), 75% with a neurologist (79% nationally), and 25% with an epilepsy specialist nurse (84% nationally). Women in both Wales and Scotland were also more likely to have had such a conversation than women in Northern Ireland.
• Women in Northern Ireland were more likely to be worried or confused after discussions with their healthcare professional (60% compared to 32% nationally). However, women in Scotland and Wales were less likely to be worried or confused (26% and 21% respectively).
• 14% of women who had not received any information from healthcare professionals came from the East Midlands. This compared to 7% of respondents from the East Midlands overall, suggesting that there may be a issue in this region.

Conclusions

More work is needed to make sure that all women taking valproate are aware of the risks of taking the medication during pregnancy and of the Prevent programme.

The biggest concern highlighted by the survey is that despite the licensing conditions for valproate requiring a prescription only to be made after the Annual Risk Acknowledgement Form has been signed and completed, half of all respondents taking valproate said they had never been asked to sign one.

It is also very concerning that there is a cohort of 56 women (11% of respondents to the survey) who said they had not received any of the Pregnancy Prevention Programme (PPP) materials from their healthcare professional.

It is clear from the results of our survey that more needs to be done to explain both the Pregnancy Prevention Programme, and the risks of taking valproate during pregnancy, particularly in Northern Ireland, and East Midlands.

More work is also needed to ensure that healthcare professionals are discussing the risks of taking valproate during pregnancy. There are still too many women reporting that they had not had a discussion with their GP (25%), neurologist (21%), paediatrician (18%) or epilepsy specialist nurse (16%).

Distribution of the patient information is lacking both within the healthcare setting and pharmacy and further steps are required to ensure this material is distributed.

The more information women receive the more satisfied they are with the programme, and importantly, the more aware they are of the risks of taking valproate during pregnancy.

Further consideration should also be given to concerns many respondents raised about the restrictions placed on them by the PPP, and being required to use unsuitable contraceptives.