Freedom of Information request (FOI 22/1028)
Published 17 January 2024
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18th October 2022
FOI 22/1028
Dear
We appreciate you taking the time to highlight this issue to us. MHRA has worked with all of the marketing authorisation holders to ensure appropriate warnings reach patients through the warnings on the packaging, the patient information leaflet, and the patient card. However, we do not regulate clinical or pharmacy practice and as such cannot enforce the use of the valproate Pregnancy Prevention Program by pharmacists. The General Pharmaceutical Council (GPhC) can inspect individual pharmacies to increase compliance and we will continue to work closely with the GPhC and other relevant organisations to support actions where ever we can in order to ensure all patients are informed about the risks of valproate.
In order to address the issue of supplying valproate without the associated warnings the Department of Health and Social Care (DHSC) led on a consultation to update the regulation to require original pack dispensing and specifically whole pack dispensing for valproate to ensure all patients receive a pack with the warnings. We understand that the response to the publication will be published soon.
Kind regards,
FOI Team
Safety & Surveillance Group