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New Law: Full packs of Valproate-containing medicines now come with safety warning


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Patients will receive warnings and pictograms, including a patient card and the Patient Information Leaflet with the pack

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription.

The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the unborn baby if valproate-containing medicines are used in pregnancy.

The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained in the manufacturer’s original full pack.

Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.

Dr June Raine, MHRA Chief Executive spoke about the necessary changes in the law and said, “It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed.

“The changes in the law announced today to ensure this happens,” he added.

“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.”

He continued: “It is very important that patients do not stop taking valproate-containing medicines without advice from a healthcare professional. If you are concerned about the risks, talk to your doctor, pharmacist or another healthcare professional.”

However, pharmacists can make an exception to dispense valproate-containing medicines in the manufacturer’s original full pack on an individual patient basis.

It will be only considered if the patient needs a monitored dosage system, and must receive the Patient Information Leaflet which contains information about the risks of valproate-containing medicine for the unborn child.


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