Safety warnings to be provided to all patients with every valproate-containing medicine they receive under new law

Valproate-containing medicines will be dispensed in the manufacturer’s original full pack, following changes in regulations coming into effect on Wednesday 11 October 2023. The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance for dispensers to support this change.

Following a government consultation, this change to legislation has been made to ensure that patients always receive specific safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are contained in the manufacturer’s original full pack. These materials form a key part of the safety messaging and alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy.

The changes follow a consultation on original pack dispensing and supply of medicines containing sodium valproate led by the Department of Health and Social Care (DHSC), in which there was overwhelming support for the introduction of the new measures, to further support safety of valproate-containing medicines.

Minister for Public Health, Maria Caulfield, said:

“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.”

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Source: MHRA, 11 October 2023