MHRA Valproate patient safety initiative

MHRA Valproate patient safety initiative

July 18, 2018

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.

In March 2018 the CMDh endorsed a strengthened regulatory position on valproate medicines.

 

Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

It is important women don’t stop taking valproate without first discussing it with their doctor.

Key messages

  1. Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the Pregnancy prevention programme
  2. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.
  3. These regulatory changes will be further supported in the upcoming months by:
  4. smaller pack sizes to encourage monthly prescribing and a pictogram/warning image on valproate labelling

All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed.

 

Key Resources

1.Link to MHRA Patient information leaflets and further details a : https://www.gov.uk/guidance/valproate-use-by-women-and-girls#toolkit

The national Patient Safety community group have launched a community pharmacy toolkit and also a clinical audit link to support pharmacies to provide key messages and information on this safety initiative.

2.Community Pharmacy toolkit : https://pharmacysafety.files.wordpress.com/2018/06/valproate-safe-supply-community-pharmacy-final.pdf

3.Community Pharmacy clinical audit link https://www.thecca.org.uk/files/Valproate%20safety%20audit%20FINAL%20140618.pdf




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