The Pharmaceutical Society of Ireland has today issued instructions to all pharmacists that they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying sodium valproate (Epilim). This includes providing counselling and including a Package Leaflet and Alert Card with each supply of the drug.
The new directive comes after the European Medicines Agency's recent recommendations on risk minimisation.
Niall Byrne, Registrar of the PSI states: "We cannot overstate the importance of informing patients of the risks associated with medicines containing valproate, which are used in the treatment of epilepsy and bipolar disorder...We are working closely with the Health Products Regulatory Authority (HPRA), the Health Service Executive (HSE) and other national stakeholders on the implementation of the new recommendations, which includes a valproate pregnancy prevention programme".
Mr Byrne added: "Patients must be counselled and provided with a Package Leaflet and Alert Card on each occasion these medicines are supplied. Anything less than this is not acceptable. If a member of the public has any concerns they should contact us on valproate.concerns@psi.ie or call 01-2184000."
Epilepsy Ireland welcomes this move by the PSI. We would strongly encourage anyone who receives valproate from now on without the leaflet or the alert card to report the incident to the PSI. Even today, it cannot be assumed that all women taking this drug are aware of the risks.
Epilepsy Ireland and the FACS Forum will continue to campaign for all valproate prescriptions to be dispensed in original external packaging which has the EU-approved warnings. Unfortunately, this is still not always happening in Ireland, as can be seen in photos published on Twitter recently under the #EpilimInABag hashtag.