As part of the continuing efforts to reduce the risks associated with the anti-seizure medication, Sodium Valproate (Epilim), the Health Products Regulatory Authority (HPRA) have recently reissued patient information materials and reminders to prescribers and pharmacists about their obligations under the Pregnancy Prevention Programme (PPP) and risk reduction measures associated with the medication.
There have been no updates to the information provided within these important documents. However, the materials being reissued is an important step in continuing to ensure that both patients and healthcare professionals are aware of the risks.
In addition, some changes have been made to the Annual Risk Acknowledgement form (ARAF), a core element of the PPP which needs to be signed annually by women taking the medication, confirming that the risks around the medication and pregnancy have been fully explained to them by their specialist.
The key content of the ARAF has remained, but the form has been simplified by removing duplication and by placing a greater focus on a shared patient/specialist approach to completing the form during the consultation. We hope this measure will go some way to helping improve communication on risks and adherence to the PPP. This updated ARAF form has been circulated to prescribers as part of the reissuing of materials, and you can also download the form at the end of this article for information.
Many of the changes included are a result of the work of the Department of Health’s Valproate Stakeholder Group – which, following representations by Epilepsy Ireland and OACS Ireland - was set up to assess the current risk reduction measures in place; and strengthen them where appropriate. Both Epilepsy Ireland and OACS Ireland are members of this group, alongside representatives from the HSE, Department of Health, and the wider healthcare community. We look forward to continuing our work as part of the Sodium Valproate Stakeholder Group.
Sodium Valproate (Epilim) is a medicine licensed in Ireland to treat epilepsy and bipolar disorder. If a woman becomes pregnant while taking Epilim, their baby is at risk of serious birth defects and developmental disorders. In 30-40% of cases where the child has been exposed to valproate in utero, the child will have serious developmental disorders. In 10% of cases, the child will have congenital malformations. For men taking the medication, a potential link between an increased risk of neurodevelopmental disorders in children of fathers treated with the medication continues to be investigated. For these reasons, there are a series of risk reduction measures associated with the prescribing and dispensing of the medication – you can find out more information on each within the relevant section of our website below:
- Visit the ‘Women’ section of our website for more information on the Pregnancy Prevention Programme associated with Sodium Valproate
- Visit the ‘Men’ section of our website for more information on the precautionary measures associated with males being treated with Sodium Valproate
Finally, we still await the official start of the inquiry into the historical licensing and prescribing of Sodium Valproate. While a chair has been appointed, direct engagement with the inquiry has not yet commenced. This is due to a delay with introducing statutory instruments required under the Data Protection Act. We understand that these statutory instruments were given approval by both Houses of the Oireachtas just before the Summer recess, meaning the inquiry should formally begin soon. We look forward to engaging with the inquiry when this happens.
If you need any information or support on your or your loved one’s journey with epilepsy, please do not hesitate to contact your local Community Resource Officer. Visit the ‘Our Local Service’ page on our website for details of your local Community Resource Officer.