MHRA issues new materials for valproate safety measures

This week the MHRA has issued new safety and educational materials for patients and healthcare professionals to support the implementation of the new regulatory measures.

These materials include:

  • Updated Patient Guide
  • Updated Healthcare Professional Guide
  • Updated Annual Risk Acknowledgement Form
  • New Risk Acknowledgment Form for male patients starting valproate
  • Patient Card
  • Pharmacy Poster
  • Warning Stickers

The new materials should be used when updating guidance and SOPs relating to supplying valproate-containing products.

Pharmacy owners are encouraged to put in place a plan to implement the first phase of new regulatory measures, which came into force on 31st January 2024, to reduce the known harms of valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.

We have previously communicated the changes in regulations regarding original pack dispensing and special container status for valproate-containing products.

The GPhC has also issued some guidance around the new regulatory measures: https://www.pharmacyregulation.org/standards/guidance/sodium-valproate-resources-and-information

A CAS alert has also been issued: CAS-ViewAlert (mhra.gov.uk)

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