Safety of Medicines and Medical Devices

Baroness Walmsley Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Walmsley (LD)]

My Lords, I also congratulate the noble Lord, Lord O’Shaughnessy, on achieving this debate and on his passionate opening speech. There can be no greater issue in relation to medicines and medical devices, apart from whether they work, than whether they are safe. I hope that the House will not be bored by the fact I agree with him, as I agree with the noble Lord, Lord Hunt. I will focus on similar issues but I also want to talk about the role of community pharmacies in ensuring the safe and cost-effective use of medicines and medical devices.

As we know, sodium valproate is a medicine prescribed for certain kinds of epilepsy and bipolar disease, and we know about the dreadful rates of birth defects in the babies of women taking these medicines during pregnancy. Despite the fact that clinicians were advised to prescribe valproate only to patients who had effective contraception and for whom no other medicine worked, and guidance was given about patient information and consent, questions arise about whether that is happening. In October 2016, a group of epilepsy charities surveyed nearly 3,000 women and reported that 20% of those who were taking sodium valproate were not aware of the risks in pregnancy. The survey was repeated a year later, when it was found that 18% of women taking the drug still did not know the risks, and 28% of women said that they had not been informed of the risks in pregnancy despite the availability of the MHRA toolkit produced in February 2016. More than two-thirds of women taking sodium valproate said that they have not received the toolkit. Philip Lee, the chief executive of Epilepsy Action, is calling for a mandatory discussion of the risks with a health professional for all women with epilepsy on valproate so that they can make informed choices before they conceive. Does the Minister agree with that?

On 30 November 2016, in answer to a question from my right honourable friend Norman Lamb MP in another place, the Minister in her former incarnation said:

“In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients. The MHRA’s current priority is working to ensure that women taking valproate are fully aware of the risks in pregnancy”.


Can the Minister now say what percentage of women taking valproate are receiving the MHRA materials? That is absolutely crucial to their informed decision. In addition, what lessons have been learned about how effectively to cascade down information and materials produced centrally? If they are produced centrally, however good they are, they are no use at all unless they get to the patients.

I turn from one medicine with considerable risks that have not been sufficiently taken into account to others for epilepsy where the risks are very low, as has been proved in other countries, yet their accessibility for patients with epilepsy in this country is not very good. I am talking about cannabis-based medicines, which, despite the change in their regulatory position last year, are still not getting to adults and children with epilepsy and other conditions which could benefit from them. Can the Minister update us on that?

The other issue mentioned by the noble Lord, Lord Hunt, is the use of vaginal mesh for pelvic organ prolapse. He is absolutely right: the NHS was very slow to listen to patients with complications after surgery and options were not available to them. Eventually, the Mesh Oversight Group was set up, which consisted of relevant professionals but, crucially, also included patients. One of its recommendations was addressing the knowledge of GPs, because it is to GPs that women go first. They go to GPs when they first realise that they may have a prolapse but, after the surgery, they go back to the GP when they feel that they have complications. The problem is that GPs do not necessarily realise what the cause might be.

As the noble Lord, Lord Hunt, mentioned, this report has particular focus on women who have developed complications. It is very important that they have access to specialist centres with multidisciplinary teams able to advise them and treat complications. I support the call of the noble Lord, Lord O’Shaughnessy, for those to become specialised commissioned hospital services. The Royal College of Surgeons, in its rather late briefing for this debate, also called for clinical trials and traceability by barcoding for all medical devices for implantation. That is important across a wide range. Can the Minister update us on the progress of those recommendations and tell us what lessons have been learned about patient involvement in policy-making? Finally, can the Minister or the noble Baroness, Lady Cumberlege, tell us about the progress of the Cumberlege review?

Given the shortage of time that GPs have to spend with their patients, community pharmacies have a big role to play in ensuring safe and cost-effective use of medicines. The New Medicine Service provides support to patients who have been newly prescribed medicines for long-term conditions. It is intended to improve medicines adherence and is focused on a small range of conditions. It has been assessed on its effectiveness and come out very well, but pharmacists are now suggesting that the service should be extended into other medical conditions where there is significantly poor adherence to the medicines regime. Is that proven intervention to be extended to other medical conditions?