Important Valproate update

We are very concerned to hear from patient groups about examples of women and girls not always being given the important information they need when sodium valproate is being supplied from pharmacies. Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. As such, it is vital that women and girls receive the right information and advice, and that valproate is dispensed safely.

Action we are taking when valproate is not supplied safely

We have recently investigated instances of pharmacies where valproate has been dispensed in a white box with no safety warnings or Patient Information Leaflet. Our Inspectors have followed up with these pharmacies and their Superintendents to make sure they understand what went wrong, that procedures are reviewed and that the whole pharmacy team is made aware of how to dispense valproate safety.

Supplying valproate safely to women and girls – what you must do

You have a professional responsibility to make sure women and girls are informed about the risks of taking valproate in pregnancy and are aware of the Pregnancy Prevention Programme (PPP) so they can make informed choices.

Watch this video created by Central & North West London NHS Trust, in which a pharmacist talks to a patient about the risks of valproate and explains the Pregnancy Prevention Programme.

Valproate must not be given to any woman or girl able to have children unless there is a PPP in place. For women and girls, when they are dispensed valproate, they should expect:

• to be provided with a Patient Card every time valproate is dispensed
• for valproate to be dispensed with a copy of the patient information leaflet
• to be reminded of the risks in pregnancy and the need for highly effective contraception, and a reminder of the need for annual specialist review
• to be asked if they have received the Patient Guide
• that that their dispensed medicine has a warning on the container. This is usually included on manufacturers packs but needs to be added if dispensed in a white box.

You must make sure that the patient label is not placed over the warning labels or warning sticker on the box. Women taking valproate have shared with us examples of where this has happened.

Copies of the Valproate pharmacy materials (warning sticker, patient guide, healthcare professionals guide, patient card and poster) can be obtained from manufacturers or viewed/printed from product pages on the electronic medicines compendium.

Manufacturers packs such as Epilim now have a perforated warning card which you can flip up or remove to reveal a space for the patient label. Make sure you keep the warning card with the box and give both to the patient.

Recommendations for community pharmacies

Our inspectors check the pharmacy team are following the requirements of the Pregnancy Prevention Programme compliance. Pharmacies should:

• ensure a system is in place in the pharmacy to flag people who are at risk to make sure they are provided with the right information
• make sure people at risk have a PPP in place and understand the risks, and refer to local contraceptive services if appropriate
• refer people who have not had a review within the last 12 months to their GP or specialist and know who to contact if their circumstances change
• record referrals and information provided on the patient medication record

Find out more in this example of notable practice on supporting people taking valproate from our Knowledge Hub. 

Information and resource to help you  all of our resources and information about valproate on one page on our website so it is easier for you to stay up-to-date.

Please share the link with your colleagues in the wider pharmacy team.