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The Independent Medicines and Medical Devices Safety (IMMDS) Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as “disjointed, siloed, unresponsive and defensive."[1] Over two years on from the publication of the IMMDS Review’s report, First Do No Harm, the Health and Social Care Select Committee has today published a new report reviewing the implementation of its recommendations to date.[2] The Review made nine overarching safety recommendations, of which the Government accepted four in full, two in part, one in principle and rejected two.[3] Following an evidence session held on 13 December 2022, the Health and Social Care Select Committee’s report focuses specifically on two of the three medical interventions considered by the IMMDS Review, sodium valproate and pelvic mesh implants, and makes recommendations for Government action on these issues. Implementing recommendations The Committee’s report highlights the need to ensure that the below recommendations of the IMMDS Review, which the Government accepted, are fully implemented: That the Medicines and Healthcare products Regulatory Agency (MHRA) substantially revises its approach, particularly in relation to adverse event reporting and medical device regulation and ensures that it engages more with patients and their outcomes. A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. That it sets up a register of clinicians’ interests and ensures this includes financial and non-pecuniary interests for all doctors. That it establishes a register of industry payments to clinicians. Ensuring that the MHRA is responsive to patients and their outcomes is a long-term piece of work. The MHRA has come forward with numerous activities aimed at improving its approach in this respect, including the introduction of a new Patient Involvement Strategy.[4] While the jury is still out on what the impact of this will be, Patient Safety Learning believes that to meet the Review’s recommendation will require more than just increased patient involvement; it will mean meeting patients’ expectations that healthcare products are safe and that patients are free from avoidable harm. Turning to the creation of a central patient-identifiable database and a register of industry payments, there has been a lack of significant progress on these recommendations to date. However, pilot work on the register of clinicians’ interest has taken place and it has been stated by the Minister Maria Caulfield MP that implementation of this will begin in 2023. On each of these recommendations, we support the Committee’s calls for increased urgency by the Government in regards to their implementation. We also believe that there should be openly published timetables setting out plans for this. You can read more about the importance of registering of clinicians interests, industry payments to clinicians and the need for greater transparency and reporting around financial conflicts of interest in healthcare in a blog on the hub by Sling the Mesh founder Kath Sansom.[5] Redress A central focus of the report is the need for greater support for the women and children affected by the medical interventions covered by the IMMDS Review. Related to this, one of the key recommendations of the Review was to establish a new independent Redress Agency for those harmed by medicines and medical devices. It was envisioned that: “The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”[1] However, the Government rejected this recommendation, along with a recommendation to establish separate redress schemes for patients adversely affected by hormone pregnancy tests, sodium valproate and pelvic mesh. Instead they pointed towards patients having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability. Patient Safety Learning believes, like many individual patients and patient groups, that this response was wholly unsatisfactory. A new blog published on the hub this week highlights how for many harmed patients affected by the interventions considered in the report the clinical negligence route simply is not viable.[6] In the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need. The Committee’s report notes that the Minister Maria Caulfield MP has indicated that she is willing to look at the idea of a Redress Agency, as well as separate redress schemes. We would welcome this and support the Committee’s call for a formal statement on this with “more details on what such a review would include and seek to achieve, and timeline for completion”.[2] Audit of mesh patients Another recommendation of the IMMDS Review was for a retrospective audit of women who had pelvic mesh surgery, to help gain a fuller understanding of the nature and extent of mesh associated complications, with this data informing decisions over future pelvic mesh surgery. The Committee’s report notes that while this audit is underway, there are significant concerns that it is failing to adequately capture mesh related complications due to the data it draws on. The report therefore recommends that the Government “consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.”[2] Patient Safety Learning supports this recommendation, which echoes the IMMDS Review’s intentions that as part of this audit: “Every effort should be made to obtain sufficient data, and the audit results (assuming it is feasible) should be used to inform decisions over the future of pelvic mesh surgery.”[1] Patient Safety Commissioner The Committee’s report also stresses its support for the work of the new Patient Safety Commissioner for England, Dr Henrietta Hughes, urging the Secretary of State to ensure her duties and responsibilities are not impeded by a lack of resource for and within her office. It suggests that any additional work she may be tasked with relating to reviewing redress arrangements should be accompanied by additional resources. Patient Safety Learning supports this recommendation. The Patient Safety Commissioner can play an important role in helping to tackle unsafe care and empowering patients; however, her office must have the necessary resources and support to achieve this as indicated by the Select Committee. Engaging with patients At Patient Safety Learning, we believe that patient engagement is key to improving patient safety and identify this as one of the six foundations of safer care in our report, A Blueprint for Action.[7] Patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account. We concur therefore with the Committee’s calls for the Department of Health and Social Care to improve its approach to this, following concerns raised by patients and patient groups: “We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting up care schemes such as this one. We therefore urge the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.”[2] Hormone pregnancy tests One area of disappointment though that we would note with the Select Committee’s report is that it does not consider any of these issues in relation to patients and family members affected by hormone pregnancy tests, one of the three interventions covered by the IMMDS Review. They state that they were unable to do so due to ‘ongoing litigation’. Patient Safety Learning does not believe this is acceptable. Many of the issues covered by this review, such as reforms to the MHRA, a register of clinicians’ interests and industry payments and potentially revisiting proposals for an independent Redress Agency, equally concern those affected by hormone pregnancy tests. While this may be complicated in some areas by ongoing legal proceedings, the exclusion of this group of patients is in our view impossible to justify. You can read more about this issue, and the work being done by patients and groups to fight for justice and improve patient safety, in an interview on the hub with the Chair of the Association for Children Damaged by Hormone Pregnancy Tests, Marie Lyon.[8] References The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Health and Social Care Select Committee, Follow-up on the IMMDS report and the Government’s response: Sixth Report of Session 2022-23, 20 January 2023. Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021. MHRA, Patient Involvement Strategy 2021-25, 1 October 2021. Kath Sansom, No such thing as a free lunch – why recording conflicts of interests must be mandatory, 9 April 2021. Kath Sansom, The difficult of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023. Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019. Patient Safety Learning, Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.

This report follows on from an evidence session held by the Select Committee on the 13 December 2022 to assess the Government’s progress against recommendations made in the Independent Medicines and Medical Devices Safety (IMMDS) report, First Do No Harm. This featured contributions from the Government Minister Maria Caulfield MP, patients and patient groups, and representatives from NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA). Summary of the reports recommendations The Government should: Urgently ensure that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented. Consider an alternative strategy for how to pro-actively contact pelvic mesh patients who have had the procedure about their post-operative experiences and possible side effects. Make the arrangements necessary to ensure the register of clinicians’ interests can be set up swiftly, subject to the pilot phase concluding, to prevent further delay. Move at pace to bring in the necessary secondary legislation to set this up a register of industry payments to clinicians. Ensure that the Patient Safety Commissioner for England’s ability to carry out her important role, as her duties and responsibilities is more clearly defined, is not impeded by a lack of resource for and within her office. The Department of Health and Social Care should: Respond to concerns raised about interactions and consultations with stakeholders around care schemes stemming from the review, reflecting on this experience and considering how to improve engagement with them in the future. The Secretary of State for Health and Social Care should: Make a statement detailing the Patient Safety Commissioner’s review of redress schemes for the medical interventions dealt with by the IMMDS review, and what additional resources will be made available to her to undertake it. The Minister for Mental Health and Women’s Strategy should: Make a statement on the review of redress and a possible Redress Agency, with more details on what such a review would include and seek to achieve, and timeline for completion.

Key findings It was identified that action could be taken at all points of the patient pathway to improve the quality of care, with a particular call to alert patients’ ‘usual’ epilepsy team when they present with a seizure. There is a need to improve documentation as, for example, 26.1% patients did not have their anti-seizure medication (ASM) written in their notes. In 38.5% hospitals, specific information or education regarding epilepsy was not routinely provided to patients until their first clinic appointment, which may be many weeks after discharge.

What is an Adjournment Debate? There is a 30 minute Adjournment Debate at the end of each day's sitting of the House of Commons. They provide an opportunity for an individual backbench MP to raise an issue and receive a response from the relevant Minister. Unlike many other debates, these take place without a question which the House of Commons must then make a decision on. Foetal valproate spectrum disorder: Fatalities Caroline Nokes, MP for Romsey and Southampton North, opened this debate by talking about the case of Jake Alcroft, a 21-year-old who died in April this year after an infection triggered by problems with his kidneys. The coroner listed foetal valproate syndrome as a contributing factor to his death because of the physical damage done to Jake as an exposed baby, which meant that his bowel and bladder did not work properly and he relied on urostomy and colostomy bags. Some key points highlighted in this debate included: Warnings about sodium valproate and the risks during pregnancy are still not being consistently displayed on pharmacy prescriptions. Some of the recommendations made in relation to this by the Independent Medicines and Medical Devices Safety (IMMDS) Review have still not been implemented effectively. There are concerns that the illness can continue down the generations, and that is not yet well understood but it is causing real fear for the families who have been affected so far. Towards the end of this debate, Caroline Nokes made three requests for the Minister: To acknowledge that sodium valproate has contributed to a death. Asking if she was satisfied that the pregnancy prevention programme is adequately effective and that the information is properly communicated to women of child-bearing age. Calling for redress for patients and families affected by this, as recommended by the IMMDS Review. Maria Caulfield MP, Minister for Mental Health and the Women's Health Strategy, provided the Government response at the end of this debate.

Thank you to everyone who has shared your powerful stories with me about your own experiences and those of family members. Your testimonies are both heartfelt and heart breaking, a very emotional read. I cannot think of a greater motivation for decision makers to do what is right, without delay. I was very privileged to meet Yasmin Golding and to hear about the #SaferMumSaferBaby campaign by the Epilepsy Society. It was humbling to hear directly from Yasmin about her hopes and fears for the future and why having information to help minimise risk would make the world of difference. Thank you Yasmin 🙏 It’s so vital that patients can get the right information about medicines to be able to make the decisions which are the safest for themselves and their families. I met with Mid and South Essex Integrated Care System and Karen Flitton for a World Patient Safety Day webinar. The theme was Medication Without Harm and it was wonderful to see so many people with a passion for patient safety. I was also very pleased to meet with the team at Healthcare Safety Investigation Branch for a morning webinar to talk about patient safety and inclusion. Thanks very much James Titcombe for the kind invitation and to everyone for your insightful questions. Patient safety in a world of ransomware attacks was part of my conversation with Nicola Byrne the National Data Guardian. With more electronic patient records and electronic prescribing, there is a risk that patients can be harmed when we don’t have timely access to information. Cyber security is key to keeping patients safe by ensuring that access to information is protected. The Speak Up Month podcast I recorded with Jayne Chidgey-Clark and the National Guardian's Office has a theme of speaking up for safety and why psychological safety is so important Listen here: https://lnkd.in/enBsUx7w Psychological safety for all was also a topic of conversation when I met with Professional Standards Authority CEO Alan Clamp. Their recent publication Safer Care for All highlights the need for a swift and coordinated system response which tackles inequalities. We can only get this right if we get it right for everyone. Such a thought provoking week- thank you to everyone who has been in touch to help me have a greater understanding about your concerns and what needs to be done to get this right. *This article was first published on LinkedIn.

What is an Early Day Motion? Early Day Motions are motions submitted for debate in the House of Commons for which no day has been fixed, and as such very few are debated. They are used to put on record the views of individual MPs or to draw attention to specific events or campaigns. By attracting the signatures of other MPs, they can be used to demonstrate the level of parliamentary support for a particular cause or point of view. Early Day Motion 349: Financial redress for victims of surgical mesh, sodium valproate and hormone pregnancy tests This Early Day Motion has been signed by Sarah Green, Jim Shannon and Jonathan Edwards. It reads as follows: That this House regrets the avoidable harm caused by the use of surgical mesh, Primodos and Sodium Valproate; acknowledges the need to support the hundreds of victims in the UK suffering as a result of these interventions; welcomes the recommendations made by Baroness Cumberlege in her 2020 report on the IMMDS Review; notes that recommendation 4 of this report calls for the establishment of separate schemes to meet the costs of additional care and support to those who have suffered avoidable harm; regrets that in the two years since the report's publication, the Government has refused to accept this recommendation; further regrets the suggestion that victims should pursue legal routes to compensation, which fails to recognise the adversarial nature and inaccessibility of litigation; and calls on the Government to establish separate schemes to provide financial redress to the victims of surgical mesh, sodium valproate and hormone pregnancy tests, as recommended by the Cumberlege report. Related reading Independent Medicines and Medical Devices Safety Review, First Do No Harm, July 2020 Independent Medicines and Medical Devices Safety Review: A joint letter from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2022 Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021 Early Day Motion - Implementation of the Independent Medicines and Medical Devices Safety Review recommendations

This has not been implemented in a clinical setting. However, parents/ carers have been involved in the initial testing and ongoing development. Feedback is provided either via the helpline, an online survey signposted within the app or the email address webquery@youngepilepsy.org.uk.

This page includes: aims and objectives of the passport a link to the tool/template guidance for professionals guidance for parents and carers guidance for children and young people.

Key themes to guide future quality measurement work for Children and young People (CYP) services: increase awareness of, and engagement with, quality measurement for CYP improve collaboration and partnership working focus on what matters most to children, young people and families simplify where possible combine existing and new data sources link measurement to action.

Key learning points: There are at least three epilepsy-related deaths a day in the UK. Sudden unexpected death in epilepsy (SUDEP) is less common in young children than in adults, but can still happen. All children suffering a first convulsion, whatever the suspected trigger, must be conveyed to A&E; even if the convulsions have stopped by the time the ambulance crew arrive. This is in case the convulsions signify a serious underlying condition requiring treatment.

What is an Early Day Motion? Early Day Motions are motions submitted for debate in the House of Commons for which no day has been fixed, and as such very few are debated. They are used to put on record the views of individual MPs or to draw attention to specific events or campaigns. By attracting the signatures of other MPs, they can be used to demonstrate the level of parliamentary support for a particular cause or point of view. Early Day Motion 78: Implementation of the Independent Medicines and Medical Devices Safety Review recommendations This Early Day Motion was sponsored by Cat Smith MP, Ben Lake MP, Apsana Begum MP, David Lidden MP, Claire Hanna MP and Tim Farron MP. It reads as follows: That this House notes that sodium valproate can cause serious problems in a developing baby; further notes that 10 percent of babies whose mothers take sodium valproate during pregnancy are at risk of having a birth defect, and up to 40 percent have problems with development and learning as they grow; welcomes the July 2020 Independent Medicines and Medical Devices Safety Review; and calls on the Government to implement its recommendations in full, including paying compensation to people disabled by sodium valproate. Related reading Independent Medicines and Medical Devices Safety Review, First Do No Harm, July 2020 Independent Medicines and Medical Devices Safety Review: A joint letter from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2022 Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021

What is an Early Day Motion? Early Day Motions are motions submitted for debate in the House of Commons for which no day has been fixed - as such very few are debated. They are used to put on record the views of individual MPs or to draw attention to specific events or campaigns. By attracting the signatures of other MPs, they can be used to demonstrate the level of parliamentary support for a particular cause or point of view.[1] Early Day Motion 556 - Government response to the recommendations of the First Do No Harm report This Early Day Motion was sponsored by Emma Hardy MP, Hywel Williams MP, Ben Lake MP and Liz Saville Roberts MP. It reads as follows: That this House notes the Government’s response to the Independent Medicines and Medical Devices Safety Review, First Do No Harm; notes with disappointment its failure to implement all nine recommendations in full; further notes that the creation of a new independent Redress Agency for people harmed by medicines and medical devices has been refused outright and that, despite the clear findings of the Report, there is no offer of compensation for any of the victims or their families; notes that the recommended mandatory reporting of all financial and non-pecuniary interests and relevant payments involving healthcare professionals is proposed not on a single database as recommended, but dispersed on individual employer’s websites; notes with concern calls from the pharmaceutical industry for the Secretary of State to use the Medicines and Medical Devices Act 2021 to mandate rapid timelines for regulatory approvals in the face of the Report’s findings of the suppression of negative research and outcomes, and the silencing of patient voices; notes the lack of commitment to mandatory reporting, underpinned by legislation, of all payments made to teaching hospitals, research institutions and individual clinicians by the pharmaceutical and medical device industries; and calls on the Government to reconsider its response and to implement all nine recommendations in their entirety and to ensure patient safety remains paramount in any changes to regulatory approval frameworks. References UK Parliament, What are Early Day Motions?, Last Accessed 15 September 2020 Related reading Department of Health and Social Care, Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021 Independent Medicines and Medical Devices Safety Review, First Do No Harm, July 2020 Independent Report of the Patient Reference Group – response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021 Kath Sansom, Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies, 15 April 2021 Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021