It has been 46 years since the granting of the license of Epilim (Sodium Valproate) in Ireland. The overwhelming impact it has had on families clearly evident. OACS Ireland families have been dealt a dreadful hand in life, and it is our duty to ensure that children and adults impacted by this drug are as comfortable and carefree now and for their long-term future and when we are no longer here. Alongside our colleagues in Epilepsy Ireland, we have written to the Minister for Health regarding the lack of progress on the key issues which we have been campaigning on in relation to Sodium Valproate (Epilim). In our correspondence to the Minister, we have identified three issues which must be urgently addressed, and which require a renewed focus on by the Minister & his department officials. These are as follows:
1) The need for the promised inquiry into the historical licensing and prescribing of Sodium Valproate to be established.
The Minister for Health announced in November 2020 that an inquiry would be established. While cognisant of all the challenges that have faced health services in the months thereafter, we have yet to receive any details on the proposed inquiry since responding to initial requests from the Department in January. We have been extremely patient on this matter since then but have been met with silence in recent months. Further delays are not acceptable. We must see details of the proposed inquiry so families affected by Valproate can get the answers they deserve.
2) The need for a stakeholder group to be established.
When a woman is prescribed Sodium Valproate, there are a number of risk minimisation measures which must be applied around the prescribing and dispensing of the drug. These ensure that all women are fully aware of the risks associated with the medication if taken in pregnancy. However, a survey Epilepsy Ireland published in 2020 of women who were taking or had been taking Sodium Valproate found that many woman were dangerously unaware of these risks. Further, we found low awareness of the actual risk minimisation measures that are supposed to be used. For this reason, Epilepsy Ireland & OACS Ireland proposed that the Minister establish a Stakeholder group to review and strengthen existing risk management measures. The group would consist of medical professionals, patient representatives, HSE, HPRA, Pharmaceutical Society of Ireland and representative groups such as the ICGP and IPU. The Minister agreed to this proposal but since last November, there has been no further progress made. This group needs to be established as soon as possible to ensure that the risks of children being born with valproate-related disabilities are minimised or eliminated.
3) The need for services to be put in place for families caring for children & adults impacted by Epilim (Sodium Valproate).
If a child is exposed to Sodium Valproate in utero, they have a 30-40% chance of having a neurodevelopmental delay and a 10% chance of having a congenital malformation. The needs of children impacted by exposure to the medication are complex, constantly evolving, and varying. Therefore, in order to support families impacted by Valproate, a suite of services and supports was proposed by the HSE’s Valproate Response Project in 2019. The vast majority of the services which were agreed have not been put in place. This has to change, and families impacted by Sodium Valproate need these vital supports. We continue to work with the HSE to ensure services are provided and prioritized for families who have received a diagnosis of Foetal Valproate Syndrome / Spectrum Disorder.
What can you do ?
You can contact your local representative and ask them to follow up with the Minister for Health on your behalf. You can read and download our correspondence to the Minister by clicking HERE.
We look forward to the Minister’s reply and will to continue to campaign on this matter alongside our colleagues in Epilepsy Ireland until these issues are resolved.
To read more about Sodium Valproate and why an inquiry was ordered by the Minister, click HERE.
**Women and girls should not stop taking valproate without first discussing it with their doctor. More information can be found HERE
OACS Ireland email address: email@example.com
Please feel free to contact Epilepsy Ireland at 01 4557500**