Dáil Éireann Debate, Thursday - 9 November 2017
148. Deputy Louise O'Reilly asked the Minister for Health the views of the HSE and his Department when their attention was drawn to the fact that pregnant women were being prescribed sodium valproate without proper provision of information on the side effects; and if he will make a statement on the matter. [47364/17]
Amharc ar fhreagraValproate medicines have been authorised in all EU Member States for the treatment of epilepsy; whilst 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.
The Irish Medical Council's Guide to Professional Conduct and Ethics requires registered medical practitioners to make sure that, "any treatment, medication or therapy prescribed for a patient is safe, evidence-based and in the patient's best interests". They should weigh up the potential benefits with the risks of adverse effects and interactions when deciding what to prescribe and should review their patients' treatment regimes periodically. Registered medical practitioners are also required to "keep up-to-date with developments in medication safety."
In 2014 a review of valproate by the European Medicines Agency 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 Health Products Regulatory Authority (HPRA) as the competent authority for the regulation of medicines in Ireland 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 the valproate-containing products was introduced in Ireland earlier this year; products carrying the new external warning label are now being supplied to retail pharmacies.
In 2015 and again in October 2017, 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;
- 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.
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.
