Doctors must review all women on sodium valproate as data shows UK-wide differences

Healthcare professionals including GPs and pharmacists are being reminded to identify and review all women who are taking the epilepsy medication sodium valproate, after data showed there is a wide variation in prescribing practices across the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update on valproate asking healthcare professionals whether they are acting in full compliance with the new strengthened measures around the drug.

Although there has been a steady decline in the use of valproate for women and girls of childbearing age with epilepsy, there are still reports of women not being informed of the risks associated with the drug during pregnancy. And some women say they are not being given patient information materials with their dispensed medicines.

Variability across UK

Across the UK there is wide variability in the number of women and girls aged 14-45, being prescribed sodium valproate. From July to September 2018, figures for Southampton Clinical Commissioning Group (CCG) show that 15.96 per cent of people prescribed valproate are women and girls of childbearing age; the similar figure in South Warwickshire is 7.07 per cent.

In 2017 there were an estimated 3.3 per 10,000 pregnancies in the UK exposed to the harm of valproate in 2017 – around 250 live births. Up to 40 per cent of babies exposed to sodium valproate during pregnancy are born with physical or neurodevelopmental problems.

The Community Pharmacy Patient Safety Group has named raising awareness of risks around sodium valproate as one of its key priorities for 2019.

Advice and information for healthcare professionals.

"An audit function is available on all GP software systems – use this now to identify and recall all women and girls on valproate who may be of childbearing potential and refer to an appropriate specialist for a review"
MHRA

Risk acknowledgement form

A survey of 78 patients by INFACT, the national valproate campaign, showed that between June and September 2018, 88 per cent of respondents had not signed the risk acknowledgment form as part of the new regulations around valproate, agreeing they had been informed of the risks of valproate in pregnancy.

Latest data

The MHRA has been monitoring trends in the prescribing of valproate to assess the effectiveness of the new regulatory recommendations and the introduction of a pregnancy prevention programme.

Valproate is prescribed for epilepsy, bipolar disorder and migraine, although the most common indication for treatment is epilepsy.

Data from the Clinical Practice Research Datalink GOLD database shows that both new and repeat prescribing of valproate in girls and women of childbearing age and in pregnancy have declined  over the period between January 2010 and June 2018.

The decline was slightly larger in the rate of new valproate prescriptions. A sharp decline in new use with adolescent girls first seen in early 2015, has been sustained.

There was a 72 per cent reduction in new use in the first half of 2018 compared with the same period in 2010. The overall rate of prescribing valproate in women with epilepsy aged 14-45, during the same period has decreased by 37 per cent. Prescribing of valproate in pregnancy also declined by 47 per cent.