A government decision that patients should not be initiated on sodium valproate without the approval of two specialists should be “paused immediately”, a coalition of epilepsy organisations has said.
The new measure requiring two clinicians to sign off a valproate prescription was announced by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2022, following advice from the Commission on Human Medicines (CHM).
The CHM had recommended that no patient aged under 55 years — including men, women and children — be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. The measure also applies to those aged under 55 years who already take valproate.
Sodium valproate is used to treat epilepsy and bipolar disorder, but can result in birth defects if taken during pregnancy.
A joint statement published on behalf of 11 UK epilepsy organisations on 27 March 2023 warned: “This is dramatic shift in practice and risk for people with epilepsy without regard to each person’s situation and life choices and totally out of proportion to the risks to patient safety.”
The statement added that there was a lack of consultation in advance of the policy change and that no details of CHM’s safety review have been made available.
“The MHRA response to a freedom of information request is clear that we will not be given any opportunity to understand their rationale behind their decisions for the extension to children and men,” it said.
On 23 March 2023, the same coalition wrote to health secretary Steve Barclay, calling for an urgent review and suspension of the policy and asking him to intervene to allow the coalition to view the evidence base for the MHRA’s decision.
In February 2023, The Pharmaceutical Journal exclusively revealed that NHS England’s Valproate Safety Implementation Group had warned that the measure could have a “negative impact” on patients and that “reducing prescribing is important, rather than limiting access to those who need it”.
Responding to the coalition’s statement, a spokesperson for the MHRA said: “In light of concerns that the current regulatory requirements for safe use are not being consistently followed, with ongoing use of valproate in pregnancy, the MHRA announced changes to the way valproate will be used in the UK.
“This followed a rigorous review of all available data and advice from the independent CHM, which has listened to the views of patients and healthcare professionals.
“The CHM’s independent implementation group, which has representation from across the healthcare system, has advised that the new safety measures are introduced through a phased programme, according to patient safety priorities, to ensure patient care is not disrupted. This will be done in collaboration with other healthcare bodies.
“The reasons for the changes were outlined in a public statement and Drug Safety Update, and a separate briefing for charities. Further information will be made available to support the implementation of these measures in due course.”