Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of actions required for this medicine. You should have received a pack of information materials for patients—if you have not yet received a pack, or if you are near to running out of any materials, you should order more using the details provided in the article.

Reminder of actions for healthcare professionals:

Actions for GPs

  • identify and recall all women and girls on valproate who may be of childbearing potential
  • provide the Patient Guide to the patient (or her parents or responsible person as necessary)
  • check they have been reviewed by a specialist in the last year (ie, they have an in-date Risk Acknowledgement Form) and are on highly effective contraception

Actions for specialists

  • book in review appointments at least annually with women and girls under the Pregnancy Prevention Programme and re-evaluate treatment as necessary
  • explain clearly the conditions as outlined in the supporting materials
  • complete and sign with the patient or their responsible person the Risk Acknowledgement Form—copies of the form must be given to the patient or responsible person and sent to their GP

Actions for dispensers

  • valproate medicines must always be dispensed with the accompanying patient information leaflet
  • dispense whole packs whenever possible, and ensure there is a warning label either on the carton or added via a sticker
  • discuss risks in pregnancy with female patients each time you dispense valproate medicines and ensure they have the Patient Guide and have seen their GP or specialist to discuss their treatment and the need for contraception
  • ensure new packs of valproate information materials are placed in a designated place accessible to all dispensing staff and dispose of any old materials related to valproate medicines

How to order more packs

Packs of information materials to support informing women on valproate of the risks in pregnancy and the need to be enrolled in the Pregnancy Prevention Programme have been sent to prescribers, dispensers, and healthcare professionals. A reminder of the key valproate materials and how to access them online is available in the May 2018, Drug Safety Update. Despite this we are hearing that women on valproate are still not receiving the information they are entitled to, including the patient information leaflet, and some women on valproate are unaware of the serious risks in pregnancy.

If you require more copies or if you have not received a pack, please contact the Sanofi medical information department without delay on 0845 372 7101 or email UK-Medicalinformation@sanofi.com.

Responsibilities of healthcare professionals

Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. As stated in the risk minimisation materials, the requirement for a Pregnancy Prevention Programme is applicable to all premenopausal female patients unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy. As for any medicine, use that does not comply with the conditions of the licence would be off-label and carry the accompanying responsibilities.

Report any suspected adverse drug reactions

Continue to report any suspected adverse drug reactions, including any case of a pregnancy exposed to valproate medicines, to the Yellow Card Scheme (see advice on reporting suspected adverse drug reactions from medicines taken during pregnancy). Should exposure occur, pregnancy outcomes should be monitored and reported.

Information resources available for those who dispense valproate

Below is a list of further information resources created for healthcare professionals:

New video available

A new video is available to support healthcare professionals in implementing the new 2018 regulatory measures, including the Pregnancy Prevention Programme and regular patient reviews.

Valproate – pregnancy prevention programme

Article citation: Drug Safety Update volume 12, issue 2; September 2018: 1.

Published 25 September 2018