The Deputy's questions regarding diagnosis of foetal anti-convulsant syndrome (FACS) are service matters for the HSE; therefore, these questions have been referred to the agency for attention and reply to the Deputy.
The Health Products Regulatory Authority (HPRA) has implemented a number of measures intended to ensure that all patients and healthcare professionals understand the risks and benefits of medicines containing sodium valproate. These measures include the introduction earlier this year of a warning label for the outer packaging of Epilim (sodium valproate) products; retail pharmacies are now being supplied with products carrying the new external warning label.
The product information supplied with this medicine also includes detailed warnings and recommendations for healthcare professionals and patients regarding the use of valproate, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. Within the last two weeks, the HPRA has been in contact with the pharmacy regulator, the Pharmaceutical Society of Ireland (PSI), to re-emphasise the importance of informing women of childbearing age of the potential risks of taking valproate-containing medicines. The PSI subsequently issued a circular to all registered pharmacists highlighting the need to include a patient leaflet and Alert Card with each supply of these medicines, and to provide additional labelling and counselling to patients as required.
Since March of this year, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has been conducting a new review to examine the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. When the PRAC's review is concluded, the HPRA will communicate the outcome and recommendations of the review to Irish patients, healthcare professionals and relevant stakeholders, including the HSE.
