The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a change in licence for valproate, which means it can no longer be prescribed to women or girl of childbearing potential unless they are enrolled on the pregnancy prevention programme (PPP).
Women and girls who take valproate, which is a treatment for bipolar disorder and epilepsy, during pregnancy are at significant risk of birth defects and developmental defects (4 in 10 babies are at risk of developmental disorders and 1 in 10 of birth defects).
Healthcare professionals are being advised to ensure all woman or girl of childbearing age is enrolled on the PPP before prescribing valproate, as well as ensuring patients sign a risk acknowledgement form when their treatment is reviewed at least annually.
Regulatory measures have already been put in place by the NHS through altering prescription behaviour and NHS Digital working with GP systems suppliers to provide a search and audit of women and girls prescribed to valproate.
Director of Primary and Social Care Technology at NHS Digital, Nic Fox, said: “All GP systems have alerts applied and we are continuing to work with some of the suppliers to ensure these high visibility alerts are consistent across primary care. These alerts ensure that GPs are prompted at the time of prescribing.”
In parallel with these changes, the National Institute for Health and Care Excellence (NICE) is amending its guidelines.
NICE has also started work on an update of its guidelines on epilepsy.
Director of the Centre for Guidelines at NICE, Professor Mark Baker, said: “NICE welcomes restricting the use of valproate in women of childbearing potential. It is important that everyone affected by these changes is made aware of them as soon as possible.
“We have therefore taken immediate steps to amend our guidelines on the diagnosis and management of epilepsies, the assessment and management of bipolar disorder, depression in adults, and antenatal and postnatal mental health to reflect this important change to the drug’s licence.”
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