Independent Medicines and Medical Devices Safety Review: Progress Report

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.

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.

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.

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.