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Medicinal Products

Dáil Éireann Debate, Wednesday - 4 May 2022

Wednesday, 4 May 2022

Questions (538)

Patrick Costello


538. Deputy Patrick Costello asked the Minister for Health the actions taken by his Department and the HSE to implement the 2014 EMA ruling in relation to Valproate specifically around educating general practitioners to the dangers of proscription; and if he will make a statement on the matter. [22269/22]

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Written answers (Question to Health)

In October 2014, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) completed a review of sodium valproate and recommended strengthening restrictions on the use of valproate in women and girls, and for women to be better informed of the risks of valproate during pregnancy. 

The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland.  The outcome of the 2014 EMA review was highlighted in the HPRA Drug Safety newsletter of December 2014, and a direct healthcare professional communication (DHPC) was issued to all healthcare professionals at that time. The HPRA also provided information to prescribers on the availability of the HSE “Valproate toolkit” in its August 2016 Newsletter.  

For its part, the HSE sought to support the safety messages of the HPRA and disseminate relevant information in many ways, including: 

- development of a Valproate toolkit through the collaborative work of the National Clinical Programmes for Medicines Management and Epilepsy, with input from HSE Mental Health division. 

- the National Director of HSE’s Clinical Strategy and Programmes sent letters to relevant organisations informing them of the availability of the toolkit. This communication campaign included letters to prescribers and patient organisations such as the Irish Institute of Pharmacy (IIOP), Irish Medication Safety Network, General Practitioners via the PCRS, Neurological Alliance Ireland, Epilepsy Ireland, College of Psychiatrists of Ireland, ICGP, etc. 

- the National Clinical Programme for Epilepsy developed an extensive practice guide for the management of women with epilepsy, which covered the pathways of care associated with all aspects of pregnancy, contraception and menopause.

As the Deputy may be aware, the EMA conducted a further review of sodium valproate in 2017-18, and subsequently recommended additional measures to avoid valproate exposure in pregnancy. These recommendations have also been implemented by the HPRA and HSE.