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 are dispensed valproate safely.
Supplying valproate safely
Pharmacy professionals have a key role in supplying valproate safely. Valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.
New rules came into force on 11 October 2023 which require manufacturer’s original full pack dispensing of valproate-containing medicines. This is to ensure that patients always receive information about the harms of valproate during pregnancy.
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.
Find out more about what you need to do in our Focus on supplying medicines safely: sodium valproate
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.
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.
How pharmacies can support women and girls taking valproate
Our inspectors check the pharmacy team are following the requirements of the Pregnancy Prevention Programme during inspections.
Medicines in Pregnancy Registry
NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) have developed a valproate registry. Work is underway to extend the valproate registry to include Scotland and Wales. Data collected in England between April 2018 and March 2023 shows:
- Of the 52,572 females prescribed valproate since April 2018, 1,218 females had a total of 1,474 conceptions
- 315 of those females were prescribed valproate in a month in which they were pregnant
- Of the 300 females, 15 were identified as new additions in the most recent 6 months, October 2022 to March 2023