Full pack dispensing of valproate-containing medicines

Legal changes have come into force for England, Scotland and Wales to ensure that all patients (male and female) receive their valproate-containing medicine in the manufacturer’s original full pack and therefore will always receive information on the risks to the unborn child. Pharmacists must give valproate-containing medicines in the manufacturer’s original full pack every time, and the amount given must be as close as possible to the amount on the prescription. This applies to both NHS and private prescriptions. This will ensure that all the safety warnings associated with taking valproate-containing medicine are clearly visible and available to patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance for full pack dispensing of valproate-containing medicines. This guidance provides the reasons why these changes have been made and what pharmacists need to do differently.

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. You must not subsequently re-package any valproate-containing medicine into plain dispensing packaging.

There will be exceptional circumstances in which the manufacturers full pack does not need to be supplied. In these circumstances a risk assessment will need to be in place. The MHRA guidance covers these circumstances and links to templates for example risk assessment will be provided when available.

The full guidance can be found on the MHRA website.

Further information about valproate risks in pregnancy can be found on the MHRA’s Valproate use in women and girls page.