From December 9th 2019 - February 28th 2020, Epilepsy Ireland conducted a survey aimed at establishing awareness of the risks associated with the use of the drug sodium valproate (Epilim) in pregnancy and individuals’ experience of the various risk-reduction measures that have been put in place by authorities following campaigning on the issue by Epilepsy Ireland and OACS Ireland.
Today we release the findings of the suvey which consists of data from 151 respondents who met the survey's criteria. All respondents are women/ girls living in Ireland and taking valproate (on or after 1 August 2018) or the parent/ guardian/ carer of a girl taking valproate in that time.
Overall, we are deeply concerned about the issues this survey has identified. Despite a concentrated effort from the HSE, HPRA and charities in recent years, too many women taking this drug are still not aware of the risks of the drug in pregnancy which include a 10% risk that a child exposed to valproate will have congenital malformations and a 30-40% chance they will have neurodevelopmental disabilities.
Although showing an improvement from our last survey in 2016, communication from healthcare professionals is still not as widespread as it should be and information materials are not being fully utilised. We are unfortunately some way off informing and educating ALL women taking this drug about its risks. Particularly concerning is that only a quarter of respondents have heard of the Valproate Pregnancy Prevention Programme, despite it being a mandatory requirement for being prescribed valproate.
The concerns identified in our survey can only be addressed by co-ordinated planning and action from a range of stakeholders. These stakeholders include the HSE, HPRA, Pharmaceutical Society of Ireland, professional bodies and patient groups including Epilepsy Ireland and OACS Ireland. Alongside our colleagues in OACS Ireland, Epilepsy Ireland calls for the establishment of a stakeholder group to consider all available data on this issue and to develop, implement & monitor new actions to address the identified issues. Capacity within the HSE’s epilepsy service must be increased to enable the mandatory annual consultations and risk checklist completion. It is unacceptable that four out of six specialist nursing posts, approved in 2018 for this purpose still remain vacant today and these must be filled immediately in order to avoid families being impacted by valproate in the future.
Positives from the survey include the relatively high usage of educational materials by pharmacists; the increased dispensing of valproate in original packaging with its package leaflet; the proactivity displayed by epilepsy specialist nurses in discussing valproate risks with patients; the fact that people find the information materials informative where they are available; and that outcomes for women switched away from valproate seem to be favourable to date. These factors will provide a solid base for a stakeholder group to build from in ensuring that all patients are fully informed about valproate.
We would like to thank everyone who took part in this survey which has provided a valuable insight that continued work needs to be done on this serious matter.
For more on sodium valproate click here. If you have any concerns, please do not hesitate to reach out to your local Community Resource Officer or your medical team. If you think your family may have been impacted by exposure to sodium valproate in utero, please contact OACS Ireland by email on firstname.lastname@example.org.
Summary of Findings
(Note: for full report, see pdf at the bottom of page)
Awareness of Risks
- 83% of respondents were aware that valproate can cause congenital malformations but just 66% were aware it can cause developmental problems.
- Only 27% of respondents said they had heard of the 'Prevent' Pregnancy Prevention Programme
- Just 30% of respondents said they had received a letter from the HSE informing them of the risks and asking them to contact their healthcare team to organise a review between July and October 2018.
Communications with Healthcare professionals
- Only 71% of respondents have ever had a discussion with a health professional about the risks of valproate in pregnancy
- Of the group who have ever had a discussion, 56% said that it took place since 1 August 2018. This represents just 39% of all respondents who have had a discussion since the introduction of the PPP.
- 67% of respondents said that they had met with their GP about their epilepsy since August 1 2018. Of these, 66% said that their GP had discussed the risk of valproate in pregnancy with them at that consultation. 34% reported that their GP did not discuss valproate risks.
- Where respondents had met with their consultant or epilepsy specialist nurse (ESN), 77% report their neurologist discussed the risks and 83% reported their ESN did so.
Patient Information Materials
- Just 30% of respondents said that they had received the 'Prevent: Patient Alert' card since August 1 2018 when receiving their prescription.
- 30% also said that they had been given the ‘Prevent: Patient Guide For Women & Girls’ booklet and by their GP or another doctor or nurse.
- Feedback on the materials was positive with 79% of respondents saying they fully understood the Patient Guide.
Annual Risk Acknowledgement Form
- 62% of respondents said they had not been asked to sign the Annual Risk Acknowledgement Form. 22% said that they had been asked, while 16% said they could not remember.
Valproate dispensing from the pharmacist
- In relation to the most recent occasion respondents received valproate from their pharmacist, 72% said they received it in the manufacturer's original box with a patient alert card and/or booklet. 9% said it was in the manufacturer's original box but with they were not given a patient alert card or booklet. 4% said they received it in a plain box/ plastic bag with no alert card/ booklet or PIL.
- 62% said that the pharmacist “always” provides the patient information booklet; 19% receive it some of the time; while 11% said that they have “never” received the booklet from their pharmacist. However, the patient alert card is 'always used' only 10% of the time.
- Just 12% of respondents said that their pharmacist “always” speaks to them about the risks associated with taking valproate during pregnancy when they collect their valproate prescription. 11% said that their pharmacist discusses it “more than half of the time”; 15% responded “less than half the time”, while a majority, 54% said that their pharmacist “never” discusses the risks when they pick up their prescription.
Outcomes of consultations
- Of those who have had a consultation with their GP, specialist or ESN since August 2018, 23% were switched from valproate to another medicine. None had been switched back afterwards.
- 10% were already taking valproate, decided to continue taking it and their doctor signed them up to the valproate pregnancy prevention programme. 33% were already taking valproate, decided to continue taking it, but their doctor did not sign them up to the valproate pregnancy prevention programme.
- Worryingly 4% reported that they were prescribed valproate for the first time but were not signed up to the valproate pregnancy prevention programme. No respondents reported that they were prescribed valproate for the first time and were signed up to the valproate pregnancy prevention programme