Dáil Éireann Debate, Tuesday - 7 November 2017
722. Deputy Billy Kelleher asked the Minister for Health if his attention has been drawn to concerns regarding the way the European Medicines Agency 2014 recommendation that sodium valproate should not be prescribed for girls and women of childbearing age is being implemented [46307/17]
View answer723. Deputy Billy Kelleher asked the Minister for Health when sodium valproate was first prescribed here; and if there are estimates of the number of children who have been adversely impacted by it [46308/17]
View answer725. Deputy Billy Kelleher asked the Minister for Health if his attention has been drawn to the fact that an organisation (details supplied) has conducted a number of surveys of women taking valproate and found that while doctor-patient communication is improving since 2014, only 56% of women surveyed in December 2016 indicated that they have had discussions on this issue with their health care professionals and the attention of 1 in 5 has not been drawn to the new restrictions in place since 2014 [46310/17]
View answer726. Deputy Billy Kelleher asked the Minister for Health his views on whether the use of valproate information resources should be mandatory and informed consent should be obtained when using the drug in women and girls; his further views on whether a valproate register should be established and properly resourced public awareness campaigns need to happen; and his views on whether warnings should be displayed on the external packaging of the drug and that valproate medication should not be dispensed without original internal and external packaging [46311/17]
View answer748. Deputy Thomas P. Broughan asked the Minister for Health the work his departmental officials are undertaking in relation to the prescribing of medicines containing sodium valproate; the number of families that have been affected by foetal anticonvulsant syndrome due to the use of this medicine; the supports being provided to these families; the measures being taken to curb use of this drug particularly in women and girls; and if he will make a statement on the matter. [46520/17]
View answer771. Deputy Róisín Shortall asked the Minister for Health if his attention has been drawn to concerns raised by the EMA regarding the implementation of its 2014 recommendations on the prescription of valproate to women of childbearing age; the actions the HSE will take to address these concerns; and if he will make a statement on the matter. [46628/17]
View answerI propose to take Questions Nos. 722, 723, 725, 726, 748 and 771 together.
Sodium valproate has been licensed for use in Ireland since 1983. Valproate medicines have been authorised in all EU Member States and in Norway and Iceland for the treatment of epilepsy; valproate-containing medicines are also approved nationally in Ireland to treat bipolar disorder.
Valproate medicines should be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. It is also recommended that valproate should not be used in women of child-bearing potential unless other treatments are ineffective or not tolerated because of the risk of congenital malformations and developmental disorders in infants exposed to valproate in utero. Women who could become pregnant should be given medical advice on the benefits and risks of treatments before valproate is prescribed and use effective contraception during treatment. Clinicians, in consultation with their patient, may consider the therapeutic benefit of valproate to outweigh any possible risks for individual patients where discontinuation of therapy or switching to alternative therapies is not possible or poses an unacceptable risk to the health of that patient and consequentially to the health of the unborn child.
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. The most recent component of the current review was a public hearing held at the London offices of the EMA on 26 September.
It is anticipated that the PRAC’s current 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.
A previous EMA review of valproate, in 2014, resulted in measures to strengthen the warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. The HPRA has highlighted the results of previous reviews of valproate and provided revised educational materials for both healthcare professionals and patients. A warning label for the outer packaging of Epilim (sodium valproate) products was introduced in Ireland earlier this year; products carrying the new external warning label are now being supplied to retail pharmacies.
In October 2016, the HSE's Medicines Management Programme (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 continues to monitor the use of valproate by women of childbearing age. The MMP is also in regular contact with the HPRA regarding the EMA's current review of valproate, and will consider any recommendations arising from the review.
Foetal Anti-Convulsant Syndrome (FACS) is the name of a syndrome that can affect some babies if they were exposed to certain anti-epileptic drugs while in the womb. FACS can manifest as physical malformations as well as developmental, behavioral and learning difficulties. Children with FACS can have a mixture of mild to more serious symptoms. The management of FACS usually involves a multidisciplinary approach with different specialties depending on the nature and severity of the symptoms. Children born with developmental delays may require specialist paediatric care, as well as speech and language therapy and physiotherapy. Information published by the HPRA indicates that children exposed in utero to valproate are at high risk of congenital malformations in approximately 10% of cases, and of serious developmental disorders in up to 30-40% of cases. There is also an increased risk of autistic spectrum disorder, childhood autism and attention deficit hyperactivity disorder (ADHD).
In October of this year, and in 2015, the Pharmaceutical Society of Ireland, as regulator for pharmacists and pharmacies in Ireland, again highlighted the risks of the use of valproate in women of child-bearing age to ensure that those patients are informed and understand:
- the risks associated with valproate use during pregnancy;
- the need to use effective contraception;
- the need for regular review of treatment; and
- the need to immediately consult a healthcare professional if they are planning a pregnancy or if they become pregnant.
Pharmacists were encouraged to bring these issues, and any other relevant educational materials, to the attention of patients presenting in their pharmacy.
The Irish Epilepsy and Pregnancy Register, based in Beaumont Hospital, was set up in 2001 for pregnant women with epilepsy in Ireland. The aim of this Register is to find out which type of epilepsy drugs women are taking while pregnant and to collect information on the health of their babies after delivery. Since 2007, the Irish Register has had a formal link to the United Kingdom Epilepsy and Pregnancy Register. Women with epilepsy who become pregnant, whether or not they are taking anti-epileptic drugs for their epilepsy, are eligible to register their pregnancy.
Patients currently taking valproate containing medicines are advised not to stop taking these medicines and, if they have any concerns about their specific drug treatment and management of their condition, to discuss these with a healthcare professional.
