Independent Medicines and Medical Devices Safety Review: Progress Report
(Limited Text - Ministerial Extracts only)
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The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)
In July 2021, the Government published their response to the recommendations of the independent medicines and medical devices safety review (the review). In this, we accepted the overarching conclusion of the review that the system failed to listen to patients, or to put patients at the centre of their care. We accepted the majority of the review’s nine strategic recommendations and 50 actions for improvement.
We also committed to publishing an update on progress made in the following year to implement the accepted strategic recommendations and actions for improvement. I am happy to be able to publish that report today, which shows that we have made substantial progress and sets out the remaining next steps. The key points are set out below.
Putting patient voice at the centre of patient safety
Dr Henrietta Hughes was appointed as the first patient safety commissioner in July 2022. Dr Henrietta Hughes is already championing the value of listening to patients to seek improvements to patient safety around the use of medicines and medical devices.
Pelvic mesh
In April 2022, the ninth specialist mesh centre opened in Bristol. Women from every region now have access to the specialist support services they need, including pain management, psychological support and surgical mesh removal. As of October 2022, over 1,900 patients had been referred for treatment.
The first annual clinical summit took place on 6 December 2022, where all nine mesh centres came together to share best practice in setting up the centres, delivering patient-centred care, and ensuring robust data collection to support continued improvement. To ensure these centres are supporting women as intended, I have asked the Department to work with NHS England to review mesh centre outcomes and patient experience.
Sodium valproate
Government take safety concerns associated with sodium valproate very seriously. Significant measures were introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018 to further reduce the use of valproate during pregnancy, including the introduction of the pregnancy prevention programme and smaller pack sizes to encourage monthly prescribing with a pictogram/warning image on valproate packaging.
The MHRA and NHS Digital have developed the medicines and pregnancy registry to improve our ability to monitor implementation and compliance with the pregnancy prevention programme. This tracks all women in England who are taking NHS-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. The latest data from the registry shows that the number of pregnant women prescribed valproate in a six-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. Last year the registry was also expanded to cover other anti-epileptic drugs in addition to sodium valproate.
Existing approaches to reduce the number of pregnant women exposed to sodium valproate are important and are making a difference, but there is no room for complacency, and we still need to do more. For that reason, the independent Commission on Human Medicines (CHM) has considered a comprehensive assessment by MHRA which included input from patients and other key stakeholders and a review of the available data.
The CHM has advised that there should be greater scrutiny of the way sodium valproate is prescribed and that further risk minimisation measures are required, in particular that two specialists should independently consider and document that there is no other effective or tolerated treatment. The CHM has established an implementation group to support the safe introduction of the new measures into clinical practice. The implementation group includes representation from across the healthcare system.
The proposed new measures will be implemented over the coming months according to patient priorities so that they can be introduced safely. In the meantime, health professionals are being reminded that sodium valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated, and the pregnancy prevention plan should be closely adhered to. It is important to note that patients taking sodium valproate are strongly advised to continue to do so until reviewed by a healthcare professional.
I will also be hosting a roundtable on valproate prescribing with key stakeholders on 19 December 2022, to discuss how we can work together to further improve monitoring and compliance with the regulatory controls.
Last year we held a consultation on original pack dispensing and whole pack dispensing of medicines containing sodium valproate, which included a proposal that medicines containing sodium valproate are always dispensed in the original manufacturer’s packaging. This would ensure patients, and particularly women and girls of childbearing potential, always receive the patient information leaflet with warnings about taking the medicine while pregnant. The Government have considered the responses received and will shortly publish a response to the consultation.
Medical device information system
Following extensive scoping work we have concluded that the best and fastest way to deliver a medical devices information system is by increasing the scope and coverage of outcome registries.
We aim to increase the scope and coverage of medical device outcome registries from 15% to 80% of high-risk procedures over the next three years. As well as device tracking the registries will include patient outcomes and patient experience, helping us deliver on wider objectives such as better information about individual consultants’ performance, which was highlighted in the Paterson inquiry.
Declaration of interests
The IMMDS review stated that transparency of payments made to clinicians needs to improve. We are in a piloting phase for the declaration of doctor’s interests in NHS and independent settings. Healthcare providers will publish this information to ensure it is more accessible to patients.
During the pilot, we will seek feedback from healthcare providers, doctors, and patients on the feasibility and cost of establishing and maintaining systems across different healthcare settings; the content of standardised templates and guidance; and the accessibility of information for patients. Full implementation will begin in 2023. Once we have a system in place for doctors, we will consider systems for other healthcare professionals.
Next steps
We know there is more work to do to improve women’s experiences of the healthcare system, and patient safety. The Government are committed to continuing to work with partners across the health and care system to implement the accepted recommendations and actions for improvement.
The review also brought into sharp focus the importance of listening to women's voices and was a key driver behind the decision to develop the first ever women’s health strategy for England, which we published this summer. Through the women’s health strategy, we will continue to improve the health and wellbeing of women and girls.
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