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PSI directs pharmacists to alert patients to valproate risks

February 22, 2018

Following new recommendations from the European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC)*, the pharmacy regulator has directed pharmacists that they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying medicines containing valproate. This includes providing counselling and including a Package Leaflet and Alert Card with each supply of these medicines.

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. The PSI’s latest notice to pharmacists regarding sodium valproate (Epilim®**) has been issued following new recommendations from the PRAC on 9 February 2018. 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.”

*PRAC Recommendations
**Epilim is a brand containing sodium valproate, which is licensed in Ireland.

Read the communication sent to all pharmacists.

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