Safety requirements for use of valproate ‘still not being fully met’, finds NHS audit

Only a quarter of patients on valproate, who do not have appropriate contraception, are being referred by their pharmacist to their GP or a specialist about the issue, an audit carried out by NHS England has found.

A report on the 2019/2020 Pharmacy Quality Scheme Valproate Audit — which was carried out in community pharmacies across England — published on 11 August 2022, has indicated that the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) safety requirements for use of valproate in women and girls of childbearing age, and trans men who are biologically able to be pregnant, are “still not being fully met”.

Since 2018, the MHRA has advised that valproate, a treatment for epilepsy and bipolar disorder, must not be used in anyone of childbearing potential, unless a Pregnancy Prevention Plan (PPP) is in place.

As part of a PPP, pharmacists are required to remind patients of the risks of taking sodium valproate in pregnancy and the need for highly effective contraception; ensure patients have been given the patient guide; and remind patients of the need for an annual specialist review.

However, the audit, which was conducted by 10,293 community pharmacies in England, including responses from 12,068 patients and patient representatives, found that pharmacists were not referring or signposting “a sizeable minority”, who appeared to be without appropriate contraception, back to the prescriber.

The report said that community pharmacists should refer “all people aged 12–55 who are biologically able to be pregnant and have not had their valproate medication reviewed within the last 12 months to their GP or specialist, as well as to local contraception services as appropriate”.

For patients not referred to their GP or specialist, the report said that the pharmacist should be able to confirm that the patient is fully informed, understands the risks of not using highly effective contraception and knows who to contact if their circumstances change.

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Source: The Pharmaceutical Journal, 12 August 2022