Guidance on withdrawal and alternatives to valproate for women
In December 2018, the Royal College of Psychiatrists published its position statement on the prescription of valproate-containing medicines to girls and women of reproductive potential, entitled ‘Withdrawal of, and alternatives to, valproate-containing medicine in girls and women of childbearing potential who have a psychiatric illness’. The statement reiterates the recent regulatory guidance issued by both the EMA (European Medicines Agency) in February 2018 and the MHRA in April 2018:
‘Valproate preparations must not be used in pregnant women. In girls and women of childbearing age, valproate preparations must not be used unless the patient meets the conditions of a “pregnancy prevention programme (PPP)”’
The PPP comprises the following features:
- Assessing patients for the potential to become pregnant
- Conducting pregnancy tests before starting and during treatment with valproate
- Counselling patients about the risks of valproate preparations
- Explaining the need for effective contraception throughout treatment
- Annual (or more frequent) reviews of treatment using a risk acknowledgement form to confirm the provision and understanding of relevant information.
The statement from the Royal College of Psychiatrists draws attention to:
- The hazards of prescribing valproate-containing medicines
- Alternatives to valproate-containing medicines
- Switching patients from valproate-containing medicines to alternative medication
- Reiterating the importance of completing the annual risk acknowledgement, making recommendations for alternative approaches.
The College acknowledges that this can be a challenging clinical issue to assess based on capacity and consent, which they will discuss in a separate paper in the future.
What should hospitals be doing?
Your visiting Ashtons Pharmacist will log a ‘clinical intervention’ on the Ashtons Live View system for any of your female patients newly admitted on or newly prescribed valproate therapy, if they are of childbearing age.
The responsibility then lies with the doctor to respond to this dialogue on Live View and to ensure the risk acknowledgment form is completed if the patient is to continue therapy, or measures are taken to switch to a safer alternative. The risk acknowledgment should then be retained with the patient’s notes for future reference. It is also vital any related relevant information is passed on to the GP or doctor when the patient moves on.
Ashtons has produced a 30-minute training seminar for doctors, addressing all issues related to the guidance, and covering the resources available for both the patient and the prescriber. Should you wish to see the seminar please contact your visiting Ashtons Pharmacist to make arrangements.
The MHRA annual risk acknowledgement for valproate can be seen on the UK Governments website.