Mattie McGrath (Tipperary, Independent)
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404. To ask the Minister for Health the measures he is taking to address concerns that diagnoses of foetal anti-convulsant syndrome are still being made due to inadequate levels of public awareness in relation to the use of valproate medicines; the number of children diagnosed with the syndrome for each of the past four years; and if he will give consideration to introducing a financial redress scheme for persons with the condition. [47930/18]

Simon Harris (Wicklow, Fine Gael)
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A great deal of work has taken place in recent months to increase awareness of valproate medicines, following the European Medicines Agency's decision to introduce new measures to prevent exposure of babies to valproate medicines in the womb.

The Health Products Regulatory Authority 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.

The pharmacy regulator, the Pharmaceutical Society of Ireland, 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 counselling and including a Package Leaflet and patient alert card with each supply of these medicines.

Meanwhile, as part of its Valproate Response Project, the HSE has written to all prescribers and pharmacists in relation to the new EMA measures and guidelines; issued letters to almost 2,700 patients who were dispensed valproate within the last six months; and developed an online resource, supported by social media activity, to provide information to patients regarding valproate and the recommendations for its use.

With regard to financial redress, I am giving this further consideration, as recommended by the joint committee.

As the Deputy's question regarding the number of diagnoses relates to a service matter, I have arranged for the question to be referred to the HSE for direct reply to the Deputy.