NHS England has created a new tool to help with decisions on whether sodium valproate should be prescribed for bipolar disorder.
The tool is aimed at women, girls and anyone who could become pregnant, aged between 12-55, who are considering or taking valproate for epilepsy or bipolar disorder.
Developed in accordance with the NICE standards framework for shared decision-making support tools, the guidance aims to help patients understand the benefits and harms of taking valproate, and come to a decision with their clinician based on what matters most to them.
Sodium valproate is prescribed as a treatment for epilepsy and bipolar disorder and can cause birth defects in around one in ten babies born to those taking it while pregnant, and developmental problems in 30-40% of children whose mothers took the medicine while pregnant.
NICE guidance states that the medication ‘must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place’.
Between April 2018 and September 2020, 180 females were prescribed valproate while pregnant, while 47,532 females (ages 0-54) overall were given one or more prescription for the drug over the reporting period and 238 females stopped receiving prescriptions of valproate prior to their pregnancy.
Community pharmacists also play a key role in reducing inappropriate valproate prescribing, including providing information to patients, reminding them of the risks to pregnancy, and undertaking patient audits.
And after the General Pharmaceutical Council (GPhC) warned that some patients were not receiving patient information leaflet alongside a split pack of valproate, the government said that it would mandate original pack dispensing of sodium valproate, so that patients receive the whole pack in the original packaging, ensuring access to safety information.
This comes after the independent Commission on Human Medicines (CHM) advised in December that two specialists must independently consider that valproate is the only effective or tolerated treatment before a patient under the age of 55 can be initiated on the medication.
The Commission also advised that men under the age of 55 should also be offered the opportunity to have their treatment reviewed. NHSE said that the Medicines and Healthcare Regulatory Agency (MHRA) would release information about additional versions of the tools for men ‘imminently’.
And around 20,000 women with an active prescription for sodium valproate received a letter in 2021 urging them to speak to their GP ‘immediately’ if they think they may be pregnant.
A version of this article was first published by Pulse’s sister title The Pharmacist