Sodium Valproate

Full pack dispensing reminder

• 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.

Exceptional circumstances 

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.

New Regulations for prescribing Valproate (does not affect dispensing process)

• 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 the 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.

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.