Dispensers must provide only complete packs of the medicine to patients. Credit: luchschenF/Shutterstock.com.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on medicines containing valproate.

Safety information on the valproate-containing therapies will be displayed on all original packaging by the manufacturer. 

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The development comes following amendments to the Human Medicines Regulations 2012 that came into effect on 11 October 2023. The new regulations cover England, Scotland and Wales.

Dispensers such as pharmacists must provide only complete packs of medicines to patients, except in some rare situations, to ensure that the precise safety warnings and pictograms on the original packaging reach all users.

The guidance will inform patients about the risks to an unborn baby from using valproate-containing medications during pregnancy.

The regulations came into force after consultation.

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MHRA chief executive Dr June Raine stated: “It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed. 

“People’s situation may change, especially with regard to the possibility of pregnancy, so it is vital that the warnings about the harms of valproate are always brought to mind.”

The government noted that there are substantial risks of birth abnormalities in the foetus and developmental issues in children if women take valproate-containing medicines during pregnancy. 

Women and girls of childbearing potential who are prescribed valproate must therefore comply with the Valproate Pregnancy Prevention Programme. 

The programme is designed to ensure that patients are fully informed of the risks linked to taking the medication and the importance of avoiding pregnancy during the treatment.

UK Public Health Minister Maria Caulfield stated: “This safety information will help patients stay informed about risks of valproate, and I encourage all dispensers of valproate to consult the new guidance carefully.

“This continues our commitment to listening and learning from the experiences of people impacted by valproate and their families and using what we hear to improve patient safety.”