Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

30. To ask the Minister for Health his plans to undertake an investigation into the current and historical use of the drug, sodium valproate; if a State-wide register of those women who were on the medicine during pregnancy, and of the children affected by foetal anti-convulsant syndrome caused by exposure to sodium valproate during pregnancy, will be established; if appropriate pathways for the diagnosis and treatment of foetal anti-convulsant syndrome, in addition to providing additional services for children affected by this syndrome, will be put in place; and if he will make a statement on the matter. [48112/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I hope the two issues I am raising today will not be matters we will be discussing for a long time but will be addressed. The first issue relates to sodium valproate, more commonly known as Epilim, taken by women with epilepsy during pregnancy. The HSE is aware it has been shown to have serious health implications for pregnant women in particular.

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank the Deputy for her question which she highlighted last Thursday on Leaders' Questions.

Sodium valproate is a medicine licensed for use in Ireland to treat epilepsy and bipolar disorder. It is now well established that children exposed to valproate in the womb have an increased risk of congenital malformations and developmental disorders. In 2014, the European Medicines Agency, EMA, conducted a review of valproate and issued advice placing additional restrictions on the use of valproate in women and girls.

In March 2017, the EMA's pharmacovigilance risk assessment committee initiated a new review of the use of valproate in the treatment of women and girls who are pregnant or of child-bearing age. It is expected this review will be concluded before the end of the year. When it is, the Health Products Regulatory Authority, HPRA, will communicate its outcome and recommendations to Irish patients, health care professionals and relevant stakeholders, including the HSE.

The HSE national clinical programme for epilepsy is developing a draft protocol for the effective management of women with epilepsy. It includes prescribing guidance and detailed advice on the management of clinical issues relating to epilepsy in pregnancy. This guide will be for consideration and approval by the HSE before the end of 2017. The national clinical programme for epilepsy will consider the outcome of the EMA review when finalising this protocol.

Patients taking valproate-containing medicines are advised not to stop taking these medicines. If they have any concerns about their specific drug treatment and management of their condition, they should discuss these with a health care professional.

Health-related therapy supports and interventions for children can be accessed through both the HSE's primary care services and its disability services. We have a duty to meet the health care needs of our people, regardless of the situation. At my request, officials from my Department are scheduled to meet representatives from the foetal anti-convulsant syndrome, FACS, forum, on 23 November. I hope they find the meeting useful in exchanging information, ideas and their concerns. It will be an opportunity to be updated on the Department's perspective.

We have several important developments in the next few weeks with the EMA and the national clinical guidelines.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Those developments are welcome. Information is available that sodium valproate should not be prescribed to girls or women of child-bearing age or pregnant women unless alternative treatments are ineffective or not tolerated.

Yesterday evening, I received an email from a woman of child-bearing age, which I am happy to share with the Minister outside of the Chamber, in which she described how she picked up Epilim from a pharmacist in a plastic bag with no information leaflet. When she asked, she was told that was because she was getting fewer than 100 tablets. If it is 99 tablets or 1,000 tablets, the risk is the same. The risks are known. In advance of any reports, since we know the potential risks to women of child-bearing potential - the HSE's phrase - who are taking this drug, the Minister should instruct his officials to ensure that information is communicated. The woman in question communicated with the pharmacy, part of a large chain. It has apologised but it is not fair to ask patients to police this.

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The Deputy has a fair point. In advance of my departmental officials meeting with the FACS forum on 23 November, I will ask them to give consideration to this issue.

The HSE's medicines management programme launched its sodium valproate toolkit, an online resource consisting of a patient information booklet, a summary guide for prescribers and a patient-prescriber checklist. This information highlights that sodium valproate should not be prescribed to girls or women of child-bearing age or pregnant women unless alternative treatments are ineffective or not tolerated. The management programme is in contact with the HPRA regarding the EMA's review and any further safety recommendations which might arise from that work.

The Deputy made the point that there should be action now. I will ask my Department to contact the HPRA to discuss the matter in advance of its meeting with the FACS forum on 23 November. I would be happy to discuss the outcome of that meeting with the Deputy.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

It is welcome that such an instruction would go out. We are not saying the medicine is necessarily dangerous but it is in certain circumstances. The more awareness there is, the better. The actions being taken now are somewhat for the future.

I have met some of the women affected and their children, some of whom are adults. They have been profoundly affected by this drug. I am not a scientist or a doctor. I cannot make that equivalence but I have met them. These children suffer from a range of conditions.

As the Minister is aware, it can give rise to spina bifida, heart defects, breathing difficulties, overlapping fingers, clubfoot, hip dislocation and distinctive facial characteristics, all of which contribute to making life extremely difficult for these women. I have met them. They are fighting very hard for services but there is no recognition of what has caused them to need the additional services. The Minister should not forget some families who have already been impacted by the issue and also need to be looked after. It cannot just be a project for the future.

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

That is a fair point. We must ensure that all appropriate information and advice is followed but the Deputy raises the legitimate issue of what to do in respect of affected children. The Health Products Regulatory Authority, HPRA, advice notes that up to 10% of children exposed in utero to valproate are at risk of a congenital malformation and it is further estimated that up to 30% to 40% of such children are at risk of serious developmental disorders. The European Facts Forum estimated that up to 400 children in this country could be affected. A paper published in 2016 indicates that the use of sodium valproate in pregnancy has declined between 2008 and 2013 and an analysis of HSE pharmacy claim data from January 2014 to August 2016 indicates a decline from roughly 2,000 to fewer than 1,700 women aged 16 to 44 who were dispensed sodium valproate medicines under the community drugs scheme in that period.

The service needs of these children should be the primary purpose of the meeting on 23 November. Health services are available regardless of diagnosis or condition but if there is a sense that there is not a proper understanding or realisation of the needs of these children I hope that can be teased out at the meeting.