Valproate Tool Kit: Updated guidelines on the use of valproate in women

 In Medicines Management Processes, MRHA News and Safety Alerts, Pharmacy Information

Unborn babies exposed to valproate during pregnancy are at very high risk (30-40 in every 100) of neurodevelopment disability – such as lower intelligence and autistic spectrum disorders, and also at risk (10 in every 100) of other birth defects. However, surveys show that a significant number of women (20%) who are taking valproate are unaware of the risks in pregnancy and haven’t been provided with any written information.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided regulatory guidance for prescribers, nurses and pharmacists and information resources for patients in recent years, and this was updated in April 2017. In girls and women of childbearing age, valproate should be initiated and supervised by a specialist and only used when other medications have not been effective or are unsuitable due to side effects.

What does the MHRA Valproate resource include?

The MHRA resources include:

  • A booklet for healthcare professionals
  • A consultation checklist for prescribers:
    – Individual risk can be minimised by use of the lowest possible effective dose
    – The need for contraception (if child bearing age)
    – The need for regular review of the need for treatment
    – The need for urgent review if the patient is planning a pregnancy
  • A guide for patients which includes:
    – What are the risks of taking valproate during pregnancy
    — What does this mean for the patient
    — Things to remember when taking valproate.
  • Information summary card for patients.

A MHRA Patient Safety Alert (reference number NHS/PSA/RE/2017/002) provides further guidance:

  • Use the valproate toolkit to support fully informed decisions in girls and women of childbearing age
  • Identify girls and women of childbearing age in order to use all relevant valproate resources in planning their care
  • Embed these valproate resources into clinical practice for current and future patients
  • Circulate this alert to build staff awareness of the valproate resources available and to understand their role in identifying girls and patients of childbearing age taking valproate


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