Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. Males taking valproate are at an increased risk of impaired fertility. As such, it is vital that valproate is dispensed safely.
New regulatory measures
From 31 January 2024:
- Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
- At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.
The Medicines and Healthcare products Regulatory Agency (MHRA) have now published materials to support the implementation of these new measures, along with a Drug Safety Update.
New safety and education materials
These materials are all available on the MHRA website and include:
- Pharmacy poster - Provides important actions for pharmacists dispensing valproate to female patients.
- Patient card - Provides key information for female patients receiving valproate on contraception and pregnancy prevention.
- Warning stickers - To be added to packaging of medicine in exceptional circumstances where the original pack cannot be dispensed.
- Patient guide - Provides those taking valproate (or their parent, caregiver, or responsible person) with information on the risks of valproate in pregnancy and the risks to male patients and what they need to do.
- Healthcare Professional Guide - Provides updated information for healthcare professionals on the risks of valproate in pregnancy and the risks for male patients, the new conditions for valproate prescribing and key points for patient discussions.
The resources also include an Annual Risk Acknowledgement Form for female patients starting valproate and at annual review and Risk Acknowledgement Form for male patients starting valproate.
Full pack dispensing
What you need to know
- Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
- Pharmacists must either round up or down so that the patient receives their supply in the manufacturer’s original full pack and ensure that they receive an amount that is as close as possible to that prescribed.
- Valproate-containing medicines must not subsequently be re-packaged into plain dispensing packaging.
The manufacturer’s original full pack does not have to be supplied where:
- a risk assessment is in place that refers to the need for the patient to be sold or supplied valproate-containing medicines in different packaging from its manufacturer’s original full outer packaging (for example, in a monitored dosage system) and
- assuming that the product is authorised, there are processes in place to make sure that the patient receives the patient information leaflet. That is not the case for unauthorised medicines, unless they are only unauthorised as a result of an assembly process.
More information and resources
Watch our film where we speak to two women whose children were affected by exposure to sodium valproate during their pregnancies, to find out why it’s so important to make sure that women are made aware of the risks when dispensing sodium valproate.
Find out more in this example of notable practice on supporting people taking valproate from our Knowledge Hub.
Read a blog from Duncan Rudkin, our Chief Executive, where he uses a revalidation reflective account to reflect on his own role in raising awareness about dispensing valproate safely
Watch this video created by Central & North West London NHS Trust, in which a pharmacist talks to a patient about the risks of valproate which explains the Pregnancy Prevention Programme.