Latest valproate information as new rules come into force

The Medicines and Healthcare Regulatory Authority (MHRA) has issued new dispensary posters, patient cards and guidance for healthcare teams as changes to valproate regulations came into effect this week.

The government body has also stressed the ‘vital role’ of pharmacists in ensuring patients are aware of the risks of valproate.

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As of Wednesday 31 January, new measures mean that valproate must not be started in new patients – both male and female – aged below 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’, MHRA guidance says.

And women of childbearing potential and girls currently prescribed valproate will need a second specialist signature if the patient is to continue with valproate after their next annual specialist review.

This is due to the ‘significant risk of serious harm’ to a baby after exposure to valproate in pregnancy, as well as other known risks such as the risk of impaired male fertility.

Pharmacy teams should continue to dispense valproate in the manufacturer’s original full pack but do not need to check for the two specialist signatures.

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They should be ready to discuss the new measures with patients and if required offer patients a referral to a specialist to discuss their treatment options.

And patients should be told to not stop taking their treatment without advice from their specialist, the MHRA said.

The MHRA has stressed the ‘vital role’ that pharmacists and pharmacy staff play in ensuring that patients know the risks of valproate, as well as in supporting the valproate Pregnancy Prevention Programme.

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‘These new measures do not change this role and we have communicated how important it is that patients are counselled on the risks by pharmacists,’ a spokesperson for the MHRA told The Pharmacist.

Read more from Dr Alison Cave, chief safety officer at the MHRA asking healthcare professionals to work together to better protect patients from the unnecessary harms of valproate, and to prescribe safer alternatives.