Deputy Rose Conway-Walsh speech.
In the Dáil, Deputy Rose Conway-Walsh raised the ongoing delays surrounding details of the promised inquiry into the historical licensing and prescribing of Sodium Valproate (Epilim) in Ireland. The Minister for Health, Deputy Stephen Donnelly confirmed in November 2020 that such an inquiry would be established after years of campaigning by OACS Ireland and Epilepsy Ireland. Unfortunately, there has been little detail ever since on the proposed inquiry. You can watch Deputy Conway-Walsh’s contribution on this in the video below. https://bit.ly/3rcRvUq
Deputy Marian Harkin- speech.
Dáil Éireann Deputy Marian Harkin- speech – Questions on Promised Legislation.
The Minister for Health, Deputy Stephen Donnelly confirmed in November 2020 that such an inquiry would be established after years of campaigning by OACS Ireland and Epilepsy Ireland. Unfortunately, there has been little detail ever since on the proposed inquiry. You can watch Deputy Harkin’s contribution on this in the video below. See link: https://bit.ly/3kxFyr0
What we are seeking:
That the inquiry into the historical licensing and prescribing of Sodium Valproate announced by Minister Donnelly in November is established as soon as possible
That the four currently unfilled Epilepsy Nurse Specialist posts approved in 2018 to manage the mandatory patient safety requirements for women who are prescribed Sodium Valproate are appointed immediately
That a stakeholder group is established by the Minister to review safety & risk measures around the prescribing and distribution of this drug.
That services are put in place to support families who have been affected.
OACS Ireland are leading discussions regarding the services which need to be in place for the families whose children have been impacted by Epilim (Sodium Valproate). Families are caring for children (many of whom are now adults) with severe disabilities and need have a full pathway of services in place to support their vast and varying needs. We want to welcome what the HSE has put in place for families however we are still in further discussions with them on a matter of outstanding issues.
Sodium Valproate (Epilim) is a common epilepsy drug which was licensed in Ireland in 1975. However, since the 1960s, it was known 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.
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. However, there has been little progress made since then on establishing the inquiry. 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.
With regard to the recruitment of nurses, in 2018 as part of the HSE Valproate Response Project, it was agreed that 6 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 2 of these nurses have been recruited.
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 was what was coined as 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 annually 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. For this reason, we alongside our colleagues in OACS Ireland have 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.
**Women and girls should not stop taking Epilim (Sodium Valproate) without first discussing it with their doctor. More information can be found at www.epilepsy.ie or by calling Epilepsy Ireland at 01 4557500. OACS Ireland can be contacted via www.oacsireland.com / firstname.lastname@example.org **