MHRA drug alert— Valproate Pregnancy Prevention Programme Update

MHRA drug alert— Valproate Pregnancy Prevention Programme Update

October 23, 2018

Date issued: 22nd October 2018

Alert reference: DDL/Valproate/October-2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a update, to be actioned within 48 hours, to community pharmacy teams on the Valproate Pregnancy Prevention Programme and the related resources available, including statutory patient information leaflets and the importance of making these available to patients.

As communicated in a news story last month, pharmacies should now have received packs of educational materials for healthcare professionals and for patients. Further information on actions required was given to dispensers in the September 2018 Drug Safety Update.

In the latest alert, pharmacy teams are reminded that although manufactures’ packs (“original packs”) contain Patient Information Leaflets (PILs) of the risks associated with valproate medicines, the MHRA has been given evidence that when bulk product is being broken down and supplied in pharmacy boxes (“white boxes”), they often do not contain the PIL. Given the serious risk of harm with valproate being used in pregnancy, the PIL should always be provided with this medicine, even when dispensed in a pharmacy box.

Additional copies of the patient information leaflet of valproate-containing medicines are available to download.

To view the alert please visit the Central Alerting System website.

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