Baroness Cumberlege
To ask His Majesty’s Government what further steps they are taking to protect patients and families from the harmful effects of sodium valproate taken during pregnancy, and what is their timetable for doing so.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
Our aim is to reduce and finally eliminate the harms of valproate in pregnancy. In December, we announced additional measures to protect women and families through a requirement for two prescribers, further warnings in the valproate product information, and improved educational materials. No woman of childbearing potential should receive valproate unless no other treatment is effective or tolerated. Implementation plans are now being finalised, with engagement with healthcare and patient organisations.
Baroness Cumberlege (Con)
My Lords, I thank my noble friend for that Answer. It goes some way, I think, to reassure many of us who have been very concerned about sodium valproate being given to pregnant women, and the result that that has had. I am seeking to ensure that, with the plain boxes which contain sodium valproate, those tablets are not actually opened without a clear warning, so that people know exactly what is contained in those boxes and the harmful effects it could have on their babies. Can the Minister tell me what is actually happening to those plain boxes, because sodium valproate should not be prescribed without a really clear warning about what it could do to babies and women?
Lord Markham (Con)
First, I thank my noble friend for all the vital work that she has done in this space. She is absolutely correct. The key thing is that there are circumstances where sodium valproate is the only effective treatment for bipolar and epilepsy-type disease problems. However, we have to ensure that if people are taking it, they are going into it with their eyes completely open, so that they fully understand the risks. That is absolutely to do with the packaging. It is also about making sure that if that packaging is split up there are leaflets in every part, and that everyone signs a consent form at least once a year, fully acknowledging the risks. Thereby, if people take the treatment, they are doing so with their eyes fully open.
Baroness Stuart of Edgbaston (CB)
My Lords, last year the Scottish Government set up an advisory group on the use of valproates. To what extent does the Minister work with the devolved Administrations to make sure that there are clear guidelines on this subject across the four nations?
Lord Markham (Con)
The regulatory authorities absolutely work closely here. It is my understanding that it is the intent of all the devolved Administrations to make sure that while there are circumstances in which this drug might be the correct treatment, as I mentioned, it is used only when everything else has been tried—and, in our case, in England—that two independent specialists will be required to prescribe it.
Baroness Wheeler (Lab)
My Lords, ensuring that patients’ decisions are based on informed consent and shared decision-making with their doctors and pharmacists is vital, especially in relation to the exception to ensuring that valproate is always dispensed in its original packaging. What steps are the Government taking to raise awareness among the health professionals involved and ensure that there is a properly joined-up approach to the advice and treatment given to the patient? How is data collection on this issue being improved, so that the effects of the safety measures and issues can be fully identified and addressed?
Lord Markham (Con)
The noble Baroness is correct. In terms of data, it is vital: first, that we have a register of all the people who are taking valproate so that we can be sure that the information is there; secondly, that we then keep a record of where patients have signed the annual acceptance; and, thirdly, that we are gaining data on testing. The latest suggestion is that we should also be looking at males taking valproate because there is evidence that it can, through their sperm, cause difficulties in pregnancies. On all those factors, data is central and we should make sure we collect it.
Lord Patel (CB)
My Lords, we have known for decades that sodium valproate, particularly when given in early pregnancy, causes 1% of babies to be born with deformity and as many as 10% to be born with learning disabilities. Despite the guidance issued two years ago, last year 250 babies were born to mothers taking high doses of sodium valproate. Does the Minister agree that we need to make the guidance much stricter, particularly about the appropriate contraception to use, and that when advising women who might be planning a pregnancy, sodium valproate should stop being prescribed for them?
Lord Markham (Con)
The noble Lord is absolutely correct. Everyone taking sodium valproate who is of childbearing age should be on a pregnancy prevention programme to make sure that those sorts of incidents do not happen. It is vital, when it is necessary for people to take it, that they really understand the risks and do everything to avoid pregnancy.
Baroness Bottomley of Nettlestone (Con)
My Lords, mention has been made of the reduction in the prescription of sodium valproate but can my noble friend clarify that with a few more figures? In the report by my distinguished noble friend, which has done so much, mention was made of a redress scheme. In December the Select Committee tasked Dr Henrietta Hughes, the Patient Safety Commissioner, to bring forward proposals of what that might look like. Can he inform the House of progress there?
Lord Markham (Con)
I thank my noble friend. Yes, the number of cases of people of childbearing age—this is a key criterion—taking sodium valproate has reduced by 33% over the past five years. The number of pregnancies has reduced by 73% but clearly that is not zero so more work needs to be done. I was speaking to Minister Caulfield this morning about the Patient Safety Commissioner. We are expecting her report shortly and from there we hope and believe that there will be a lot more we can do on regulation.
Baroness Bennett of Manor Castle (GP)
My Lords, I refer to the work of Dr Hughes, the Patient Safety Commissioner, and the initial Question from the noble Baroness, Lady Cumberlege, which referred to where sodium valproate is prescribed in different numbers of pills from the number that come in a packet, so the excess pills are taken by the pharmacist and put into plain paper packaging. The Patient Safety Commissioner has identified this as a real issue because sodium valproate must not be dispensed without the appropriate safety labels, but that is clearly happening. What are the Government doing to stop it?
Lord Markham (Con)
The noble Baroness is correct. First, the MHRA is working on guidelines which say that you must always dispense in the original packaging, come what may. In the meantime, secondly, all pharmacists should absolutely be putting leaflets in, whatever the packaging. Thirdly, everyone should have to sign an acceptance form so that they are going into this with their eyes open and understand the risks. Every year they are supposed to renew that acceptance form to make sure that, while it may be necessary in some cases, everyone goes into it with their eyes open to the risks.
Baroness Brinton (LD)
My Lords, in 2020 after the publication of the report by the noble Baroness, Lady Cumberlege, we had many debates in your Lordships’ House about the role of and the support for the Patient Safety Commissioner. She had not heard what her budget for the current financial year was at the beginning of May and said that, even leaving that aside, she would not be able to do her job properly. To follow the course of how patients with sodium valproate are supported and treated, she will need that resource. Will the Government review the resource needed for her to do this and many other tasks in her important role?
Lord Markham (Con)
My understanding from speaking to Minister Caulfield on exactly this subject this morning is that she has recently spoken to the Patient Safety Commissioner, who is happy that she has the resource that she now requires to do this part of the study.
Baroness Hollins (CB)
My Lords, I note that the damage caused by sodium valproate happens during the first trimester, when many women do not realise they are pregnant for a while, and, despite attempts to plan pregnancy, many pregnancies are unplanned. It is one thing to say that it is the woman’s knowledge, understanding and consent, but what about the long-term care of children who are born with damage caused by sodium valproate? What measures are being taken to attend particularly to the needs of this group?
Lord Markham (Con)
The noble Baroness is correct that unfortunately there will always be some cases. Dr Charlie Fairhurst has been advising the Government on how best to create the care pathways so we can make sure that we are catering for the children in this scenario. How it manifests itself, as I am sure the noble Baroness understands, is in things such as increased autism or cystic fibrosis, for which we have existing patient pathways for treatment. We must make sure that these children can get quick and easy access to those treatment pathways.