I propose to take Questions Nos. 372 to 375, inclusive, together.
This Department continues to liaise with the HSE and the Health Products Regulatory Authority (HPRA), as well as other stakeholders, to help address concerns raised over the use of sodium valproate, also known as Epilim.
As part of its Valproate Response Project, the HSE undertook a communication programme in 2018 to provide information to support the safe prescribing of valproate treatment in women with epilepsy, bipolar disorder and other conditions, to help prevent current and future harm to women of childbearing age who are pregnant or who could become pregnant while taking valproate medicines. To date, the communications plan has included:
1. Issuing letters to all prescribers and pharmacists in relation to new European Medicines Agency (EMA) and HPRA guidelines on the use of sodium valproate;
2. Issuing patient-specific letters to GPs;
3. Issuing 2500+ letters to patients who were dispensed sodium valproate;
4. Issuing letters to pharmacies advising them of the patient support service and requesting that they include a patient information leaflet every time they dispense sodium valproate;
5. Developing an information web page regarding sodium valproate; and
6. Using social media to provide regular updates to patients and stakeholders.
In addition to this HSE programme, the HPRA has collaborated with national stakeholders, including patient representatives and healthcare professionals, to implement the EMA’s new risk minimisation measures in Ireland.
These measures have 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.
In tandem with the actions taken by the HPRA, the Pharmaceutical Society of Ireland (PSI), as pharmacy regulator, has directed pharmacists that they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying medicines containing valproate. This includes providing a patient leaflet and Alert Card with each supply of these medicines.
On 22 March, the HSE, together with Epilepsy Ireland and the Organisation for Anti-Convulsant Syndrome (OACS) Ireland, held a public conference on sodium valproate with the aim of creating awareness for patients who were not included in the communications issued in 2018. Over 300 members of the public registered for this event, which focused on the response to this issue to date by the HSE and the HPRA.
With regard to diagnostic pathways, the HSE has advised that it has allocated funding for a dedicated Genetics Clinic to be situated in the National Children's Hospital Group. A consultant paediatrician has been appointed, and all paediatric patients referred to date with suspected foetal valproate syndrome (FVS) have been reviewed. The HSE has established a working group to identify the support service needs of patients diagnosed with FVS.
The approved product information and Package Leaflet for sodium valproate now includes detailed warnings and recommendations for healthcare professionals and patients regarding use of the drug, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. New packaging for Epilim products now includes a boxed warning and a pictogram indicating that use of sodium valproate can seriously harm an unborn baby. The PSI regularly reminds pharmacists that they must provide counselling and include a package leaflet and patient alert card with each supply of valproate medicines, whether or not the supply is made to the patient in the manufacturer’s original packaging.