Valproate-containing medicines (also known as sodium valproate or valproic acid) are approved in Ireland under the brand name Epilim, for the treatment of epilepsy and bipolar disorder. Based on the totality of available scientific data on this drug, it is known that children exposed in utero are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).
To prevent exposure during pregnancy, there is a robust regulatory framework for the licensed use of Epilim in women of childbearing potential. This regulatory framework was strengthened following participation by the Health Products Regulatory Authority (HPRA) in two EU-wide reviews in 2014 and 2017.
After the European Medicines Agency (EMA) issued new recommendations on the use of sodium valproate in early 2018, the HPRA collaborated with national stakeholders, including patient representatives and healthcare professionals, to implement the new valproate risk-minimisation measures in Ireland. These measures included changes to the product information for patients and healthcare professionals; a visual warning on the packaging of valproate medicines; updated educational materials to reflect the new measures and provide age-appropriate advice; and a patient alert card to be attached to the packaging so that pharmacists can go through it with the patient when valproate is dispensed.
To support the actions taken by the HPRA, the Pharmaceutical Society of Ireland directed pharmacists that they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying any medicine containing valproate. This includes providing counselling and including a Package Leaflet and Alert Card with each supply of these medicines.
To address the more operational aspects of this issue, a HSE Valproate Response Project was established in May 2018 under the remit of the HSE Office of the Chief Clinical Officer. The Project Team was able to provide expert support to individuals and families with concerns about previous exposure to valproate and the possible impact on their children. The HSE team has also worked to improve the structures in place to support families affected by foetal valproate syndrome. A specialist dedicated genetics clinic has been established in Our Lady’s Hospital, Crumlin, to support diagnosis, and the HSE is working to improve access to genetic testing.
The HSE’s medium- to long-term response to the valproate issue is focused on the establishment of a Programme for Women’s Health in Epilepsy within one of the Regional Epilepsy Centres, which will coordinate this national response. This means that all women taking valproate will have yearly follow-up, sign a valproate agreement form, be kept up-to-date with developments and signposted to other services, including the diagnostic service for those potentially exposed during pregnancy.
I have recently committed to holding an inquiry into the historical licensing and use of sodium valproate in Ireland and have asked officials in my department to examine a number of different options for the structure of this inquiry.