Michael McGrath (Cork South Central, Fianna Fail)
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272. To ask the Minister for Health the HSE's policy in relation to sodium valproate being taken by a woman through pregnancy; the research that has been carried out here on the issue; and if he will make a statement on the matter. [47667/17]

Simon Harris (Wicklow, Fine Gael)
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Sodium valproate is a medicine licensed for use in Ireland to treat epilepsy and bipolar disorder.

In March of this year, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) initiated a new review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. This review is examining the available evidence and consulting with relevant stakeholder groups.

It is anticipated that the PRAC’s review of valproate will be concluded before the end of this year. As soon as the review is concluded, the Health Products Regulatory Authority (HPRA), which is the competent authority for the regulation of medicines in Ireland, will communicate the outcome and recommendations of the review to Irish patients, healthcare professionals and relevant stakeholders, including the HSE.

The HSE's Medicines Management Programme (MMP) is already actively involved in this area. Following a previous EMA review of valproate in 2014, the MMP convened a working group with representation from the National Clinical Programmes for Epilepsy and Mental Health to review available resources for the safe use of valproate in females. The MMP also consulted with the HPRA, the drug’s manufacturer, and with relevant patient groups.

In October 2016, the MMP launched its Valproate Toolkit, an online resource consisting of a patient information booklet, summary guide for prescribers and a patient/prescriber checklist. This information highlights that sodium valproate should not be prescribed to girls or women of childbearing age or pregnant women unless other treatments are ineffective or not tolerated. The MMP is in contact with the HPRA regarding the EMA's current review of valproate, and any further safety recommendations will receive appropriate consideration.

A research paper published in 2016 indicated that the use of sodium valproate in pregnancy declined between 2008 and 2013 in Ireland, based on the number of female patients aged 16-44 years who were dispensed the drug under the community drug schemes. A follow-on analysis of HSE pharmacy claims data from January 2014 to August 2016 indicates a decline (from approximately 2000 patients to fewer than 1700 patients) in the number of women aged 16-44 years who were dispensed sodium valproate medicines under community drug schemes in that period. The HSE continues to monitor the use of sodium valproate in women of childbearing age via its Medicines Management Programme.

The HSE Clinical Strategy and Programmes Division has developed the National Clinical Programme for Epilepsy, to provide the best value, safe care for all people with epilepsy in the right place, at the right time, sharing the best information available. The model of care under the national clinical programme includes the development of a very detailed protocol for the effective management of women with epilepsy. This protocol has been developed with input from the neurology, obstetric and paediatric specialties, but is intended for all healthcare professionals. It will cover the pathways of care and clinical issues associated with all aspects of pregnancy, contraception and menopause in epilepsy, as well as the responsibilities for clinical staff in relation to detailed management. It will include detailed support for the obstetrics service in the management of seizures and guidance for ante-natal care, including prescribing protocols and specific information covering the known extra risks of epilepsy associated with pregnancy to both the mother and foetus.

This practice guide for the management of women with epilepsy is for consideration and approval by the HSE before the end of 2017.