Minister for Health Simon Harris has stated that parents affected by the drug sodium valproate have been 'let down' after the issue was raised yesterday in the Dáil by Fianna Fail TD, Bobby Aylward.
The Minister met with a selection of parents affected by the drug last month and has expressed his commitment to the issue.
"Unlike in the past with other people in the Department of Health I've taken a very interest in this issue", said Minister Harris.
Last February the new European Medicines Agency made recommendations on valproate which included:
- A new pregnancy prevention programme to support individual decision making; provide counselling and ensure annual treatment reviews.
- New visual warnings on outer packaging, including the use of pictograms
- The increased role of pharmacists in ensuring patient safety, through the use of a new reminder card each time the medicine is dispensed
In addition, the FACS (Foetal Anti-Convulsant Syndrome) Forum is calling for a range of other actions to be proactively taken in Ireland to reduce future incidence of FACS and to better support the individuals and families already affected:
- Conduct a national epidemiological study to identify individual cases of diagnosed and suspected FACS.
- All women of childbearing potential currently taking valproate and under GP-only care should be given priority referrals in 2018 to a specialist in epilepsy/ bipolar disorder for an urgent treatment review
- Establish nationally maintained registers for women prescribed with Valproate and of children affected by FACS
- Put in place streamlined diagnostic pathways for cases of suspected FACS via Clinical Genetics or other appropriate services in order to close the diagnostic gap.
- Undertake an audit of the needs of individuals & families affected by FACS and of the services/ supports provided to them
- Establish an independent investigation or inquiry into the historical use of Valproate in Ireland
Minister Harris will contact in the Forum in the next month with his proposed course of action.