The General Pharmaceutical Council (GPhC) has clarified what pharmacists need to do following a Medicines and Healthcare products Regulatory Agency (MHRA) warning to men taking valproate.

Last week, the UK medicines regulator said men taking valproate and their partners should use effective contraception, because of a small increased risk of harm to children if the drug is used by a father at conception.

Healthcare professionals should inform male patients about this ‘newly identified risk’ at their next routine treatment review and discuss how it impacts their current treatment and other options available, the MHRA said.

And in an email to pharmacy professionals, the GPhC said pharmacy teams should continue to dispense valproate and should be prepared to discuss the new advice with patients.

This includes reminding patients on valproate that they must not stop taking their treatment without advice from their specialist, and ensuring patients receive the valproate patient card and patient guide.

The GPhC is also urging pharmacy professionals to display the valproate pregnancy prevention programme poster for pharmacy teams in their dispensaries.

The new advice follows a retrospective observational study which found a possible association between valproate use by men and a small increased risk of a range of neurodevelopmental disorders in their children when compared to men prescribed lamotrigine or levetiracetam.

In the study of records from Scandinavian countries, researchers found around five out of 100 children had a neurodevelopmental disorder when born to fathers treated with valproate compared with around three out of 100 when born to fathers treated with lamotrigine or levetiracetam.

The advice in the new Drug Safety Update is a ‘precautionary measure’, the MHRA said, and while the study did not prove a link the findings raised an important safety issue that warranted action.

A version of this article first appeared in our sister title Hospital Pharmacy Europe.