Mr. Kilian McGrane:

I thank the committee for the invitation to attend this morning's meeting. I am joined by my colleagues, Dr. John Murphy, consultant neonatologist at the National Maternity Hospital and the HSE's clinical lead for neonatology, Dr. Peter McKenna, clinical director for to the women and infants programme and Ms Cora Flynn, who is an advanced nurse practitioner in epilepsy in St. Vincent's University Hospital, and also a member of the HSE's sodium valproate national response team.

We would like to address some of the concerns about the use of sodium valproate medication during pregnancy. The agent, available since 1967, is widely used to treat patients with epilepsy. It is particularly useful in the treatment of juvenile myoclonic epilepsy, JME. In addition to patients with epilepsy, the medication may be used in psychiatric patients with bipolar disorders. The concerns about the use of sodium valproate in pregnancy stem from the adverse effects that it may have on the foetus. It is accepted that this drug may cause malformations and-or neurodevelopmental delay in the unborn infant. The risk of a congenital malformation is 10%. The types of malformation associated with the drug are spina bifida, limb abnormalities, cleft lip or palate, unusual facial appearance with a narrow prominent forehead and receding chin. The risk of neurodevelopmental delay is approximately 30% to 40%.

There may be delays in motor development, speech delay and memory problems.

In a paper entitled Fetal Valproate Syndrome: An Irish Experience, the department of genetics at Crumlin hospital describes 29 cases diagnosed in the period from 1995 to 2016. This publication demonstrates the wide spectrum of abnormalities that can result from the exposure to sodium valproate during pregnancy. Pregnant women with epilepsy are commonly encountered at antenatal clinics. It is estimated that in Ireland approximately 400 women with epilepsy go through pregnancy each year. In the current era, it is uncommon to find that an expectant mother is on sodium valproate medication. Most are on alternative anti-epileptic drugs such as Kepra or Lamictal. The default position is that sodium valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women. There may be exceptions when no other agent is able to control seizures, for example in some cases of juvenile myoclonus epilepsy. In this scenario, the patient should be under a neurologist who can oversee, modify and monitor the treatment. Important factors are the use of effective contraception and the need for rapid consultation if the patient becomes pregnant All healthcare professionals need to be fully aware of the risks posed by taking sodium valproate during pregnancy. Pharmacists should be in a position to both explain and give the patient the "Key Facts - Valproate and Pregnancy" card. The information contained on this card highlights the risk to the foetus.

The matter of unintended consequences must also be considered. Epilepsy is a serious disorder. In the last tri-annual report for the UK and Ireland, there were 14 deaths from epilepsy in pregnancy, or 0.4 per 100,000. A patient with epilepsy should not stop her medication suddenly if she becomes pregnant. The right course of events is that she should seek urgent medical advice and be changed to an alternative medication, where possible, in a controlled manner.

On a more general note regarding foetal malformations, it should be noted that in the four-year period from 2009 to 2011, there were 136 cases of spina bifida, 121 cases of anencephaly and 31 cases of encephalocoele recorded in Ireland. Thus, one per 1,000 pregnancies is affected. Countries that have introduced folic acid fortification of food have seen a 60% reduction in the incidence of these conditions.

This concludes my opening statement. Together with my colleagues, I will endeavour to answer any questions members may wish to pose.