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Thirteen UK healthcare bodies launch ‘pragmatic’ guidance on valproate use

2nd April 2019

The iHV is delighted to have worked and collaborated with experts from national bodies, including seven Royal Colleges, to launch new practical guidance to support doctors and other health professionals around valproate use in women and girls in their reproductive years.

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.

Of note to HVs from the Guidance:

Midwives could notify the GP and Health Visitor on discharge from hospital that the baby has been exposed to valproate (or other antiepileptic drugs) in utero. This should be coded on medical records and entered into the baby’s “Red Book”. The best way for standardised coding across settings will need to be defined. Health visitors should be competent to monitor for fetal anticonvulsant syndrome (FACS) during child development checks, so that they are able to identify and refer early. In order to fulfil this role, they need access to training and resources. The consensus view is that specialist routine follow up of all babies at risk of FACS should be recommended, so that health, education and social care services can optimise the care of these children and help their families.

The Institute is working with some of the experts to develop some Good Practice Points for Health Visitors on this guidance – so keep an eye out for these coming shortly!