Valproate: dispense full packs of valproate-containing medicines
Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
Following a consultation, the Government has amended the Human Medicines Regulations 2012 (HMRs) to require manufacturer’s original full pack dispensing of valproate-containing medicines.
We published guidance for dispensing of valproate-containing medicines.
The change came into force in England, Scotland and Wales on 11 October 2023. While the legislative change currently does not apply to Northern Ireland, the guidance on dispensing valproate-containing medicines should be considered by pharmacists in Northern Ireland as good practice.
Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack from 11 October 2023. You 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.
The aim of amendments to require manufacturer’s original full pack dispensing of valproate-containing medicines is to ensure that women always receive information about the harms of valproate during pregnancy. This will further decrease the number of babies who are exposed to valproate in pregnancy.
The change in practice will ensure that patients (male and female) are provided with the specific warnings and pictograms on the labelling and a detachable patient card, along with the statutory Patient Information Leaflet.
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 (for example, in a monitored dosage system) and there are processes in place to make sure that the patient receives the Patient Information Leaflet.
Dispensers of valproate are also reminded to provide patients of childbearing potential with the patient card (if not affixed to pack) and patient guide as part of the Pregnancy Prevention Programme.
See our published guidance for more information about these measures and why the rules on dispensing valproate-containing medicines have been changed.
Article citation: Drug Safety Update volume 17, issue 3: October 2023: 3.