Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Baroness Cumberlege Excerpts

Tuesday 2nd March 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I will leave it to the response to the Cumberlege review to make the decision on the redress scheme. In the meantime, our focus is on a regime ensuring that those who take this important drug have the right advice to prevent them becoming pregnant. I emphasise that specialists review the treatment and ensure that an annual risk acknowledgment form is signed by the prescriber and the patient. This is an important measure ensuring that all those who take this potentially life-changing drug acknowledge and understand the implications of becoming pregnant.

[Baroness Cumberlege (Con) [V]]

My Lords, in our report we suggested that every pregnant woman who is on sodium valproate should be warned by her GP of the potential harm to her unborn child. Can my noble friend please tell me how many of the women exposed to this danger have been notified, and what the plans are to ensure that in future they are told? What incentive is given to GPs through the quality outcomes framework to ensure that they carry out this very important duty?

[Lord Bethell (Con)]

My Lords, as I explained a moment ago, there is an annual risk acknowledgment form signed by the prescriber and the patient, and that is shared with the patient’s GP. GPs should check that the patient has signed an up-to-date annual risk acknowledgment form each time a repeat prescription is issued. We have instituted a valproate safety implementation group that analyses, along with the MHRA, compliance with this plan. We acknowledge the review’s recommendation to introduce an indicator on safe prescribing in pregnancy for future iterations of the quality outcomes framework, and we will respond on that with the rest of the response to the review.