New regulatory measures tightening the rules around valproate prescribing are set to come into force from January 2024, and the Medicines and Healthcare products Regulatory Agency (MHRA) is urging healthcare organisations to adequately prepare.
From the new year, the first phase of the new measures will curb the use of valproate in new male or female patients under 55 years of age unless two specialists independently find there is no other effective or tolerated treatment, or that there are ‘compelling reasons that the reproductive risks do not apply’.
The measures aim to reduce the significant risk of serious harm to babies if sodium valproate, valproic acid or valproate semisodium are taken during pregnancy, as well as the risk of impaired fertility in males associated with the drug’s use.
These regulatory changes have been recommended by the Commission on Human Medicines to increase scrutiny of valproate prescribing and ensure that valproate is only used when the benefits outweigh the risk.
In addition to limiting new valproate prescribing, the measures include using a revised valproate Annual Risk Acknowledgement Form at the next annual specialist review of all women who could become pregnant and girls who are currently taking valproate.
This review will include the need for a second opinion’s signature if the patient is to continue with valproate.
A similar system will be introduced later in 2024 for male patients currently taking valproate.
The MHRA is urging healthcare organisations to adequately prepare for the changes, including designating a new or existing group to co-ordinate their implementation.
It is also encouraging patients to attend any offered appointments to discuss their treatment plan and to talk to a healthcare professional if they are concerned.
Dr Alison Cave, MHRA chief safety officer, said: ‘To better protect patients from [harm], we are taking robust regulatory action to ensure greater scrutiny of valproate prescribing. Valproate should only be used when no other treatment is effective.’
She added: ‘No one should stop taking valproate without advice from their specialist.’
Dr Henrietta Hughes, the Government’s independent patient safety commissioner for England, said: ‘We must dramatically reduce the number of babies exposed to teratogens which can cause physical and learning disabilities in children. To do this, all organisations must ensure they bring in new measures from January 2024.’
Professor Munir Pirmohamed, chair of the Commission on Human Medicines, added: ‘I am pleased to see the recommendations of the independent Commission on Human Medicines being prepared to be put into practice.
‘Valproate is a highly teratogenic medicine that also carries known risks to male fertility – it is therefore vital valproate is only used when there is no other effective or tolerated treatment option.
‘We have consulted with patients and healthcare professionals with experience of valproate to inform our recommendations and to ensure that they are introduced in a way that does not disrupt ongoing patient care.’
According to the MHRA, it is estimated that one in nine babies exposed to valproate during pregnancy will be born with major birth defects and as many as four in 10 born with a neurological disorder, ranging from poor educational attainment to autism spectrum disorder.
In May, NHS England launched a valproate decision support tool to help maintain patient safety and curb inappropriate prescribing of valproate during pregnancy.
And in September, new measures recommending the avoidance of all medicines containing topiramate during pregnancy were published by the European Medicines Agency‘s Pharmacovigilance Risk Assessment Committee.