MHRA: Full pack dispensing of valproate-containing medicines (11 October 2023)

Summary

This is guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). These amendments currently apply in England, Scotland and Wales. This guidance should be regarded as good practice by pharmacists in Northern Ireland.

The change comes into force in England, Scotland and Wales from 11 October 2023. 

Content

Valproate-containing medicines are used in epilepsy and bipolar disorder. There are known risks associated with valproate-containing medicines, including significant risks to children of mothers who took a valproate-containing medicine during pregnancy. Exposure of an unborn baby to valproate during pregnancy is associated with a high risk of congenital malformations (11%) and neurodevelopmental disorders (30–40%), which may lead to permanent disability. 

Following a consultation, the Government has put in place amendments to the Human Medicines Regulations 2012 (HMRs) to:

• require manufacturer’s original full pack dispensing of valproate-containing medicines
• enable pharmacists to supply up to 10% more than or less than the amount on a prescription of medicines other than those containing valproate, so that they can dispense a manufacturer’s original full pack instead of splitting the pack, known as original pack dispensing (OPD).

This guidance provides information on the reasons for the change to dispensing of valproate-containing medicines (as above), and outlines what pharmacists need to do differently.