The ‘pan-College’ advice is based on 2018 regulations issued by the Medicines and Healthcare Products Regulatory Authority (MHRA) around the prescribing and dispensing of valproate - but looks at the more challenging issues that clinicians across primary and specialist care might encounter in daily practice. These include transition from paediatric to adulthood services, competence to consent to treatment, and confidentiality.
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 in pregnancy.
The MHRA regulations state that valproate should not be prescribed to women in their reproductive years without a pregnancy prevention plan (PPP), unless a girl or woman suffers from a type of epilepsy that is not responding to other treatments.
The authors of the new guidance take a pragmatic approach, considering issues through life stages. It does not profess to answer every complex ethical issue but brings together data and best practice from the collaborating bodies across the UK, as well as signposting to a wide range of helpful resources.
Royal College of Paediatrics and Child Health Clinical Lead, Dr Daniel Hawcutt said:
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.
Valproate should only be prescribed as long as girls and women are on a pregnancy prevention programme, ideally long acting reversible contraception (LARCs). It is equally essential that women should not stop taking valproate without medical advice. Women and girls are advised to seek advice from their GP and/or specialist team before conception or as soon as they are aware that they are pregnant. For those with epilepsy, the lowest effective dose of the most appropriate anti-epileptic drug should be prescribed and they should be looked after by a specialist team throughout pregnancy.