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Sodium Valproate (Epilim) Campaign

pack of Sodium Valproate medication

There are/have been several aspects to our ongoing campaign surrounding Sodium Valproate, some of which have been progressed and are now in a different phase to when we first began campaigning on this matter. We continue to work with our colleagues in OACS Ireland to progress the outstanding issues and this page provides a summary of this entire campaign

Key issues

  • That the inquiry into the historical licensing and prescribing of Sodium Valproate announced by Minister Donnelly in November 2020 is established. Current status: Terms of reference agreed with Department of Health and awaiting cabinet approval. 
  • That the three outstanding epilepsy nurse specialists promised in 2018, and for which funding was secured in 2022, be recruited. Current status: Funding approved in 2022 and awaiting recruitment of nurses. 
  • That a Stakeholder Group be established to assess and strengthen the risk reduction measures associated with Sodium Valproate. Current status:  The Stakeholder Group was established in November 2022 and the work of the group is continuing. 
  • That the necessary services are put in place to support families who have been affected by Sodium Valproate. Current status: Our colleagues in OACS Ireland are continuing to engage with the HSE on the services families need to support their loved ones. 

About the campaign and key issues

Sodium Valproate (Epilim) is a common epilepsy drug which was licensed in Ireland in 1975. However, since the 1960s, evidence was emerging that the drug could have a severe impact on the unborn child if prescribed in pregnancy. Despite this, it was not until 2014 and again in 2018 that significant measures were taken to warn women of childbearing age about the potential impacts of this drug. In the years since it was first licensed in Ireland, many women continued to be prescribed Sodium Valproate with no warnings. 

For this reason, Minister for Health, Deputy Stephen Donnelly announced in Nov 2020 that an inquiry would be established into the historical licensing and prescribing of Sodium Valproate. This was a very welcome development. Families affected by this drug have waited long enough for answers on why this was allowed to happen to them, and the promised inquiry needs to be urgently established. In the years that followed the Minister’s announcement, a lengthy process between the Department of Health and OACS Ireland & Epilepsy Ireland was undertaken to agree the strongest Terms of Reference possible for the prospective inquiry. Towards the end of 2022, the terms of reference were finally agreed, and we await Government sign-off for these terms.

A key aspect of this campaign has also related to increased Epilepsy Nurse Specialist capacity to assist with the implementation of the Pregnancy Prevention Programme associated with Sodium Valproate.  In 2018 as part of the HSE Valproate Response Project, it was agreed that six Epilepsy Nurse Specialists would be appointed to epilepsy services in Ireland. The recruitment of the nurses would help to ensure that women currently on the drug were being informed yearly about the risks and to have discussions around family planning. This would help prevent families from being impacted by Sodium Valproate in the future. To date, only three of these nurses have been recruited. However, following continued campaigning by Epilepsy Ireland and OACS Ireland, in 2022, we received confirmation that funding had been secured for the outstanding positions. It is now vital that these posts are filled without delay. You can read more on this key development of our campaign by visiting the ‘News’ section of our website.

Another key aspect of our campaign surrounded the establishment of the Sodium Valproate Stakeholder Group. While good work has been conducted in strengthening risk reduction measures on the use of Sodium Valproate since 2018, there is still much work left to do. The pinnacle of the risk reduction measures introduced is what is called the Pregnancy Prevention Programme. This meant that any women on Sodium Valproate had to be reviewed annually by their clinician and that they had to sign an acknowledgement every year stating they were fully aware of the risks associated with the drug. In 2020, an Epilepsy Ireland survey found that many women who had taken or were taking the drug were dangerously unaware of the impacts Sodium Valproate could have and indeed, were equally unaware of the risk reduction measures that should be applied when on the medication. In addition, subsequent research from the RCSI reported concerning findings around the awareness of the risk reduction measures associated with Sodium Valproate amongst Healthcare Professionals.

For this reason, we alongside our colleagues in OACS Ireland called for the establishment of a stakeholder group. This would involve all involved in this issue (Department of Health, HSE, HPRA, GP & Pharmacy representatives, Patient Representatives etc) coming together to review the measures that are currently in place and to discuss where they can be strengthened – so we can ensure that no child is affected by exposure to Sodium Valproate (Epilim) in the future. Our campaigning led to this Stakeholder Group being established in late 2022 and the important work of this group is now underway. You can read more about this key development by visiting the ‘News’ section of our website.

As the representative organisation of families who have been impacted by Sodium Valproate, our colleagues in OACS Ireland are leading discussions regarding the services which need to be in place for the families whose children have been impacted by Sodium Valproate. Families are caring for children (many of whom are now adults) with severe disabilities and need a pathway of services in place to support their vast and varying needs.

Latest News 

The below are some of the latest updates on this matter  in the news section of our website and from national media reports, where you can read more:

Further information

**PLEASE CONTACT YOUR HEALTHCARE TEAM IF YOU HAVE ANY CONCERNS. DO NOT STOP TAKING VALPROATE WITHOUT FIRST SPEAKING WITH YOUR PRESCRIBER.**