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New valproate safety materials released by MHRA

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New valproate safety materials released by MHRA

New regulatory measures are in place to reduce the known harms from valproate.

This includes the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.

Safety and educational materials are available from the MHRA together with a Drug Safety Update.

These include a pharmacy poster, patient card and guide, warning stickers to be added to medicine packaging in exceptional circumstances where the original pack cannot be dispensed, and a healthcare professional guide.

The guide provides updated information on the risks of valproate in pregnancy and the risks for male patients, the new conditions for valproate prescribing and key points for patient discussions. 

The resources also include an Annual Risk Acknowledgement Form for female patients starting valproate and at annual review, and a Risk Acknowledgement Form for male patients starting valproate.

The new regulatory measures came into force on January 31.

Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.

At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.

Pharmacy teams should:

  • Remind patients on valproate that they must not stop taking their treatment without advice from their specialist
  • Continue to dispense valproate 
  • Be prepared to discuss the new safety measures with their patients 
  • Make sure patients receive the patient card and patient guide
  • Display the poster in the pharmacy.

What pharmacists need to know:

Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.

Pharmacists 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. 

Valproate-containing medicines must not subsequently be repackaged into plain dispensing packaging.

Exceptional circumstances 

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 from its manufacturer’s original full outer packaging (for example, in a monitored dosage system)

Assuming that the product is authorised, there are processes in place to make sure that the patient receives the patient information leaflet. That is not the case for unauthorised medicines, unless they are only unauthorised as a result of an assembly process.

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