New guidance on women’s use of valproate announced

As reported by the RCGP, 13 national bodies (including seven colleges) have created new, pragmatic guidance for the use of valproate in women during reproductive years

Experts from 13 national bodies have come together to create new guidance that will support health professionals regarding the use of valproate in women and girls.

Valproate is licensed for use only in the treatment of epilepsy and bipolar disorder, as it carries significant risk of birth defects and developmental disorders in children born to women who take the drug during pregnancy.

The advice is based on 2018 regulations issued by the Medicines and Healthcare Products Regulatory Authority (MHRA) around the prescribing and dispensing of valproate.

However, it also examines the more challenging issues that many clinicians encounter, such as the transition from paediatric to adult services, confidentiality and ability to consent to treatment.

The authors of the new guidance have taken a pragmatic approach to this topic, considering issues through life stages.

Professor Helen Stokes-Lampard, chair of the Royal College of General Practitioners, said: “Valproate use is now under strict regulation and we have clear guidance that it should not be prescribed to women in their reproductive years unless there are exceptional circumstances – but complex situations can occasionally arise.

“The care of women with epilepsy can span GP and specialist care and I do hope this guidance will provide much-needed support to doctors across all medical specialties, helping them to act in the best interests of the individual girl or woman, and ultimately improve the care we provide to our patients.

“Producing this report has taken a huge amount of work and I thank everyone who has been involved and contributed to it.”

Professor Sanjay Sisodiya, representing the Royal College of Physicians and the Association of British Neurologists, added: “The regulations around valproate have been well publicised. Their implementation in practice can throw up difficult situations. We hope that this document will provide both practical guidance and an illustration of the general approach which will be of value to clinicians.

“We hope also that the joint provenance of the guidance will ensure consistent messages for clinicians and patients. We realise that additional changes may occur and intend to update the document over time.”

Dr Angelika Wieck from the Royal College of Psychiatrists, said: “Managing mental health is particularly important for childbearing girls and women. Although valproate is an effective drug for the treatment of bipolar disorder, when taken during pregnancy it often causes serious problems in the physical and mental development of the baby.

“The new MHRA regulations are designed to minimise exposure in pregnancy and the Royal College of Psychiatrists welcomed the opportunity to contribute to this important guidance to support clinicians in implementing the new regulations and providing the most effective and safe care possible.”

Royal College of Paediatrics and child health clinical lead, Dr Daniel Hawcutt commented: “The dangers of valproate to the unborn child are now well recognised, so prescribing in women is now limited. However, it can be an effective medicine to treat seizures, especially in children.

“This pan-college advice is designed to help paediatric neurologists, as well as other groups, implement the MHRA toolkit and pregnancy prevention programme appropriately across all age groups, and in those with particularly complex circumstances including pre- and peri-pubertal girls, or those with complex neurodisability.”

Mr Edward Morris, VP of clinical quality at the Royal College of Obstetricians and Gynaecologists, said: “Most women with epilepsy have straightforward pregnancies. But careful management of the condition is needed before conception and during pregnancy, because there are risks which need to be minimised and are associated with maternal use of valproate and birth defects and developmental disorders in children.

“We welcome the publication of this guidance that provides further clarification for healthcare professionals on the use of valproate.”

Birte Harlev-Lam, executive director for professional leadership at the Royal College of Midwives, added: “This is clear and helpful guidance that supports the recent MHRA publication regarding Sodium Valproate in pregnancy.

“It adds to and harmonises the information health professionals provide when discussing pregnancy with young adults and women who may be taking or could be prescribed Sodium Valproate. It is a great example of the multidisciplinary team working in collaboration for the benefit of the people we care for.”

Carmel Bagness, professional lead midwifery and women’s health at the Royal College of Nursing, said: “The RCN is pleased to have played a part in producing this new guidance, which will be welcomed by midwives and nurses, setting out the evidence and pathways of care recommended for girls and women who may be at risk from valproate use pre-conception and during pregnancy.

“The guidance recognises the extra support needed by women with epilepsy when they become pregnant, and the difficult decisions that sometimes need to be taken. Having clinically-backed information on best practice will be a great help to nursing and midwifery staff.”

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