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Mark Hughes

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  1. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Letters, medicines recalls and device notifications sent to healthcare professionals in November 2025 News and guidance on: Reported Cases of Patient Deaths Among Duchenne Muscular Dystrophy Patients Receiving Duvyzat®▼ (givinostat) and reminder of risk mitigation measures Tamoxifen: update to product information on QT prolongation and monitoring recommendations for high-risk patients MHRA begins hosting Patient Safety Commissioner
  2. Content Article
    Every year in Australia, an estimated 140,000 people experience a diagnostic error. For 21,000 people, it causes serious harm. For 4,000 people, it’s fatal. In this blog, the authors make the case for a national policy that puts diagnostic safety on the agenda, and drives real change to prevent errors before more patients are harmed.
  3. Event
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    Healthcare-associated infections (HAIs) remain a major, yet largely preventable, burden across all countries—contributing infection in 7% of hospital patients in high income settings, and 15% in Low and Middle-Income Countries thereby imposing significant costs on health systems and society. Environmental cleaning is a critical component of infection prevention and control strategies. However, it is often overlooked in terms of staffing, funding, and research investment. Over the past five years, a coalition of leading organizations—including WHO, ICAN, WaterAid, UK-PHRST, and LSHTM—has worked to raise awareness of this missed opportunity to reduce infection transmission. Join this event on 11 December, where speakers will highlight the collaborative efforts to strengthen the evidence base for environmental cleaning in healthcare settings. The event will mark the publication in Lancet Microbe of findings from a recent cluster randomized trial conducted in Cambodia which evaluates the effectiveness of the WHO training package on environmental cleaning. The programme will feature presentations, a panel discussion, and a Q&A session, followed by a networking reception. Find out more here.
  4. Content Article
    The Maternity Outcomes Signal System (MOSS) was developed by NHS England in response to the East Kent Reading the signals report. This recommended the development of a safety signal system capable of monitoring routinely collected maternity and neonatal outcomes to detect potential declines in safe care in a timely way. MOSS operates at trust site level. It is a near-real time safety signal system that supports early detection and rapid responses to potential safety issues in intrapartum care service delivery. These standard operating procedures explain the responsibilities of trust boards and maternity services, Integrated Care Boards, regions and the national team in relation to MOSS.
  5. News Article
    Electronic patient record systems pose “persistent” risks to patients and have directly contributed to several incidents of harm, a national safety watchdog has found. The Health Services Safety Investigations Body (HSSIB) has today published the findings of its thematic review into patient safety issues associated with EPRs, which examined 112 of its investigations dating from 2018 to May this year. The review found EPRs have contributed to incidents where patient care was missed, delayed or incorrect, and that the risks were “persistent despite national recommendations and guidance”. Read full article (paywalled). Source: Health Service Journal, 27 November 2025. Related reading You can read Patient Safety Learning's response to this report here.
  6. News Article
    A monthly injection could enable severe asthma patients to stop taking daily steroid tablets without affecting their symptoms, a new trial has found. The drug, Tezepelumab (also known as Tezspir and made by AstraZeneca), works by binding to and blocking a protein that drives airway inflammation. The injection is recommended as an additional maintenance treatment for patients over 12 when usual medications have not proven effective enough. It was approved for NHS use by the National Institute for Health and Care Excellence (NICE) in 2023. Read full article. Source: The Independent, 27 November 2025.
  7. News Article
    An NHS trust has been fined £200,000 for failing to provide "safe care and treatment" for a 16-year-old girl who died on hospital grounds after fleeing her ward. Ellame Ford-Dunn, from Upper Beeding, West Sussex, died at Worthing Hospital in March 2022 where she had been admitted as a mental health inpatient. She ran into the grounds of the hospital and was not immediately followed by a nurse because of "confusion" and a lack of appropriate procedure in place, the court heard. Last month, University Hospitals Sussex NHS Trust (UHST) pleaded guilty to failing to provide safe care and treatment to Ellame which exposed her to a significant risk of "avoidable harm". Read full article. Source: BBC News, 26 November 2025.
  8. Content Article
    On the 27 November 2025, the Health Services Safety Investigations Body (HSSIB) published a new report looking at patient safety issues associated with electronic patient record (EPR) systems. It is a thematic review which draws on findings from investigation reports by HSSIB and its predecessor organisation – the Healthcare Safety Investigation Branch (HSIB). In this article, Patient Safety Learning sets out its reflections on the report’s findings. HSSIB investigates patient safety concerns across the NHS in England and in independent healthcare settings where safety learning could also help to improve NHS care. Their latest report, Patient safety issues associated with electronic patient record (EPR) systems – a thematic review, summarises and analyses their previous investigation findings relating to EPR systems.[1] Its intention is to identify themes arising from these investigations and to share any additional safety learning. Patient Safety Learning welcomes HSSIB undertaking this work. We contributed to this report during its consultation stage and, in this article, we set out our reflections on its findings. EPR systems An EPR is a set of electronic information about a single patient. It can include: a patients’ own notes test results observations by a range of different clinicians prescribed medications. EPR systems are a way of managing clinical information with the intention of making it more easily accessible to both patients and healthcare professionals. They are becoming increasingly common in healthcare settings across the world and are a core part of how patient care is delivered. Patient Safety Learning perspective When safely implemented, EPR systems can help to support and improve care and treatment. However, there are also significant patient safety risks associated with their implementation and use. At Patient Safety Learning we highlighted a number of these issues last year in our report, Electronic patient record systems: Putting patient safety at the heart of implementation.[2] We believe patient safety should be core to all EPR systems, with robust safety considerations integrated throughout every stage of their introduction: Development Patient safety must be at the heart of the initial procurement, design, configuration and development of EPR systems. There should be a focus on: Interoperability (the ability to work with other computer systems or software used by the organisation to exchange and make use of information). Usability and design for safety, taking a user centred systems and human factors approach. Designing EPRs in collaboration with the staff who will use them. Rollout As EPRs are introduced into organisations, it is vital that the appropriate training and support is provided to staff. There needs to be: Sufficient usability testing (allowing staff who would be using these systems the opportunity to try them and provide feedback) Time allowed for amendments being made to reflect the most efficient and effective processes. Staff should not have to undertake significant workarounds to make an EPR functional; it needs to meet their needs as healthcare professionals and decision makers. A greater role for EPR manufacturers in providing training and support to staff. Implementation Once an EPR is in place, monitoring how it is operating in practice and learning and acting on any risk assessments, incidents or near misses that take place relating to this, is essential. In each of these stages there should be clear steps to involve and engage both patients and frontline staff as part of this process. HSSIB report Considering the patient safety issues associated with EPR systems, HSSIB’s new report states: “The review found that EPR systems could contribute to the risks of patient care being missed, delayed or incorrect. These risks were persistent despite national recommendations and actions seeking to mitigate them.” They grouped their findings into three main categories: Choosing an EPR system capable of meeting the needs of an organisation Implementing an EPR system that meets the needs of users Seeking feedback and ongoing EPR system optimisation Choosing an EPR system capable of meeting the needs of an organisation Before introducing a new EPR system into a healthcare organisation, it is vital that the appropriate planning and preparation takes place. Introducing these systems should be recognised as major organisational change programmes, and as such require the requisite investment of time and commitment from organisational leaders. HSSIB’s report picks up on a number of issues in this area, highlighting that: Organisations do not always have a clear understanding of their requirements/needs from an EPR system, limiting their ability to match requirements to system capabilities. Choosing an EPR system at the procurement stage is complicated by this lack of understanding, which is often compounded by limited awareness of how these systems meet national requirements, including interoperability (the ability to work with other IT systems) and clinical risk-management standards. They found evidence of limited support at a national or regional level to help organisations identify their local requirements/needs for an EPR system. Implementing an EPR system that meets the needs of users At Patient Safety Learning we believe that healthcare professionals and those who will be the primary users of EPR systems should be involved in each stage of their design, planning and implementation. HSSIB’s report also underlines the importance of this, noting issues including: Implementation of an EPR system was found to be a complex project that did not always effectively engage users to ensure it was safe and successful. When users were involved in EPR system implementation they were not always representative of those using the system in practice, with difficulties releasing staff from clinical work to contribute to implementation. Staff training in how to use an EPR system was often perceived to be limited. It did not always reflect how a system would be used in the ‘real world’, or offer advice on what to do if the EPR system failed. Seeking feedback and ongoing EPR system optimisation In our response as part of the consultation on this report, we emphasised the importance of the ongoing monitoring of how an EPR system operates after it has been introduced. This is a key issue we also highlighted in our report last year, connected with the often discussed concept in patient safety of the difference between ‘work as imagined’, ‘work as prescribed’ and ‘work as done’.[3] [4] With EPR systems, we need to look at the difference between how these are intended to work, and how they work in practice. Once an EPR system is live, there should be ‘continuous feedback loops’ to understand, and learn from, how it is working. We are therefore pleased to see that HSSIB highlight a number of these issues in their report, including: Staff reported limited routes for raising concerns about poor functionality and usability of EPR systems, and limited action when concerns were reported that could impact on patient safety. Ongoing management of EPR systems, including upgrades and changes, did not always align with the digital standards for clinical risk management. EPR systems were not always kept up to date in line with national guidance and standards, or changes to internal care processes. There were limited opportunities for organisations to share their experiences of implementing and optimising EPR systems for the benefit of other organisations. In seeking to assure the clinical safety of their health IT software, organisations in the NHS are required to meet a formal standard titled DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems. This standard, which is completed by a trust purchasing a system: “… provides a set of requirements suitably structured to promote and ensure the effective application of clinical risk management by those health organisations that are responsible for the deployment, use, maintenance or decommissioning of Health IT Systems within the health and care environment.”[5] DCB0160 documentation is typically completed by the clinical safety officer before the system is launched. The standard suggests that this also applies post launch. We think this exercise would be of particular value in the case of EPR systems, if it was also completed several months after launch as such a system may look and operate quite differently to the way it was expected to pre-launch. At Patient Safety Learning, we believe that organisations should consider completing a DCB0160 post-implementation. Concluding comments This new report from HSSIB makes a strong and valuable contribution on the subject of EPR systems and patient safety. The local-level learning prompts in the report, intended to help organisations consider and mitigate risks around procuring, implementing and optimising EPR systems, are particularly helpful. EPR systems have the potential to improve patient treatment and safety, increase efficiency and reduce the costs of healthcare. However, there are patient safety risks associated with their introduction and implementation. To fully realise their benefits, we need to ensure patient safety considerations are at the heart of their design, development and rollout. References HSSIB. Patient safety issues associated with electronic patient record (EPR) systems – a thematic review. 27 November 2025. Patient Safety Learning. Electronic patient record systems: Putting patient safety at the heart of implementation. 31 July 2024. Steven Shorrock. The Varieties of Human Work. 5 December 2016. Claire Cox. Putting the writing on the wall: Explaining work as imagined vs work as done. 1 August 2023. NHS England, DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems, Last Accessed 26 November 2025.
  9. Content Article
    This report is a thematic review of investigation reports by HSSIB and its predecessor organisation – the Healthcare Safety Investigation Branch (HSIB) – that included consideration of electronic patient record (EPR) systems. Its intention is to identify themes arising from these investigations and to share any additional safety learning. You can read Patient Safety Learning's response to this report here. Key findings Choosing an EPR system capable of meeting the needs of an organisation Where EPR systems did not have the functions an organisation needed or did not support the user (patients and staff), they had contributed to patient safety incidents. There were inconsistencies in the terms used in the design of health IT systems and their functions, such as usability and functionality, and limited guidance to support understanding of these concepts in EPR system design. Organisations did not always have a clear understanding of their requirements/needs for an EPR system, limiting their ability to match requirements to system capabilities (the things a system can do). When procuring EPR systems, organisations sometimes faced challenges understanding system capabilities and whether they met required national standards, such as for interoperability (the ability to work with other IT systems) and clinical risk management. National and regional support for organisations to identify their local requirements/needs to inform EPR system procurement was limited. Some EPR system procurement decisions were perceived by staff to be influenced by factors other than system capabilities, such as cost savings. Implementing an EPR system that meets the needs of users Variation in governance processes for implementing EPR systems at national, regional and organisation levels meant associated risks to patient safety were not always identified and mitigated. Implementation of an EPR system was found to be a complex project that did not always effectively engage users to ensure it was safe and successful. Local configuration of EPR systems had the potential to introduce new risks to patient safety, with investigations identifying where this had occurred without the organisation recognising and mitigating against these risks. Factors contributing to an organisation’s ability to locally configure EPR systems included the capacity and capability of digital teams, the level of involvement of users in testing, support from manufacturers, and awareness and application of digital standards for clinical risk management. When users were involved in EPR system implementation they were not always representative of those using the system in practice, with difficulties faced releasing staff from clinical work to contribute to implementation. Several organisations faced challenges relating to the availability of working hardware and Wi-Fi connectivity to support the use of EPR systems in different clinical environments. Staff training in how to use an EPR system was often perceived to be limited. It did not always reflect how a system would be used in the ‘real world’, nor what to do if the EPR system failed. Seeking feedback and ongoing EPR system optimisation Staff reported limited routes for raising concerns about poor functionality and usability of EPR systems, and limited action when concerns were reported that could impact on patient safety. Ongoing management of EPR systems, including upgrades and changes, did not always align with the digital standards for clinical risk management. EPR systems were not always kept up to date in line with national guidance and standards, or to reflect changes to internal care processes. Factors contributing to limited ongoing optimisation of EPR systems after initial implementation included the need to manage a range of local digital priorities, limited collaboration between digital and clinical teams, cost of upgrades, and limited resourcing for ongoing work and infrastructure. There were limited opportunities for organisations to share their experiences of implementing and optimising EPR systems for the benefit of other organisations.
  10. Content Article
    Artificial intelligence (AI) is transforming health systems, reshaping how care is planned, delivered and governed. This report presents the first assessment of AI integration into health systems across the whole of the World Health Organization (WHO) European Region, based on findings from the 2024–2025 survey on AI for health care. It examines national strategies, governance models, legal and ethical frameworks, workforce readiness, data governance, stakeholder engagement, private sector roles and the uptake of AI applications. Drawing on insights from 50 Member States, the report explores how countries are navigating opportunities and challenges, highlighting emerging trends, gaps and practices to guide policy-makers towards coherent, ethical and people-centred approaches to AI in health care. The report’s key findings are organized into six sections, corresponding to the survey's themes: the navigators: steering AI strategy and oversight for health systems the change-makers: stakeholder engagement and workforce development the guardrails: legal, policy and guideline structures for AI in health the backbone: health data governance for trustworthy AI the catalysts: leveraging AI for health requirements the gatekeepers: tackling adoption barriers
  11. Content Article
    This infographic is from the Health Service Executive (HSE), the publicly funded healthcare system in the Republic of Ireland. The graphic is intended to share learning on choking incidents in the HSE and or HSE funded services, complementing their Patient Safety Supplement on ‘Reducing and managing the risk of choking in adults’.
  12. Content Article
    This letter from Jeremy Hunt MP, Chair of the All-Party Parliamentary Group (APPG) for Patient Safety, to Dr Penny Dash, Chair of the National Quality Board (NQB), sets out the APPG's views on how the NQB can help to create a more coherent and systematic approach to managing patient safety recommendations across the NHS. It suggests what recommendations the NQB could consider as part of this, how it could approach prioritisation and how it could measure and monitor the implementation of these actions.
  13. News Article
    The first details of the government’s new national maternity and neonatal taskforce have emerged in a letter sent to families, reports the New Statesman. The document confirms the group will be chaired by Wes Streeting MP, with Women’s health minister Baroness Merron as his deputy. The taskforce will have around 15 members in total and be up and running early in the new year. It will be tasked with turning the recommendations from the national maternity and neonatal investigation into a national action plan. Three of its 15 members will represent families, and each of those voices will be part of a wider “reference group” of 15-20 families. However, some have expressed concerns about the plans as not reflecting feedback sent by bereaved and harmed families back to the government in July. Read full article. Source: The New Statesman (21 November 2025)
  14. News Article
    New rules that force general practices in England to accept online queries from patients during core working hours are already risking harm to patients and increasing GPs’ workload and stress, a survey indicates. More than half (55%) of general practices polled in a BMA survey said online consultations were having a negative effect on patient care. Some 1341 practices responded to the survey, around 22% of England’s total number. Together, those practices represent almost 14 million registered patients. The Department of Health and Social Care dismissed the data, saying the survey involved a “small minority of GP practices” and did not reflect the national picture. Read full article (paywalled). Source: BMJ (20 November 2025)
  15. News Article
    A new at-home injection has been approved for use on the NHS offering a significant breakthrough for approximately 1,500 individuals in England and Wales living with a rare heart condition. Vutrisiran will be available for patients suffering from transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a debilitating illness where the liver-produced protein transthyretin misfolds, leading to deposits that stiffen the heart. Without intervention, this progressive condition can tragically culminate in heart failure. Vutrisiran, sold under the brand name Amvuttra and made by Alnylam Pharmaceuticals, works by binding to, and stifling messenger RNA (mRNA) to reduce the amount of transthyretin made by the liver. The injection, taken every three months by patients in their own home, has been recommended by Nice as a treatment option for some adults with ATTR-CM. Read full article. Source: The Independent (21 November 2025)
  16. News Article
    A trust under fire for quality and governance failures has been reprimanded by a watchdog for withholding information about a meeting of its senior leaders over maternity failures. The row relates to a meeting of the CEO, chief medical officer and chief nurse of Leeds Teaching Hospitals Trust with the chair and director of corporate governance at Swansea Bay University Health Board in February this year. Swansea has, like Leeds, been subject to major concerns about maternity and neonatal care failures in recent years, and in the summer was criticised in an independent review. The online meeting was held weeks after LTHT admitted that the deaths of 56 babies and two mothers may have been preventable, as its maternity and neonatal services came under increased scrutiny. Read full article (paywalled). Source: Health Service Journal (21 November 2025)
  17. Content Article
    Patient Safety Learning are seeking to recruit additional Trustees to lead the charity. The closing date for applications is 11.59pm on Wednesday 31 December 2025.
  18. Content Article
    This hub page links to an open access chapter of the book Safer Healthcare: Strategies for the Real World which considers that different challenges and different types of work require different safety strategies. It reflects on three broad approaches to the management of risk, which each have their own characteristic approach that can give rise to an authentic way of organising safety and possibilities for improvement. The chapter outlines three different approaches to safety, illustrated by the graphic below:
  19. Content Article
    This patient safety podcast episode from the Royal College of Paediatrics and Child Health (RCPCH) focuses on psychological safety in healthcare settings. This is the condition in which you feel safe to learn, safe to contribute and safe to challenge the status quo. The discussion features Dr Dal Hothi, a paediatric nephrologist at Great Ormond Street Hospital and Dr Jess Morgan, a paediatric doctor and Dinwoodie RCPCH Fellow. You can find a transcript of the podcast episode here.
  20. Content Article
    This national patient safety alert has been issued by the NHS England National Patient Safety team. This alert is for action by acute, community and mental health providers, health and justice services, primary care including nursing and care homes, general practice and community pharmacy. All actions should be completed as soon as possible but no later than 20 November 2026. This alert has been issued in response to concerns of patients with penicillin allergies being incorrectly recorded as a penicillamine allergies in electronic prescribing systems. This creates a risk of a patient with a known penicillin allergy being administered a penicillin-based antibiotic and having a potentially fatal anaphylactic reaction. The risk of this error is not specific to any one electronic prescribing system. Actions required At health system level Primary and secondary care organisations should form a working group across an appropriate geographical area, chaired by an appropriate chief clinical information officer, to co-ordinate implementation of the following actions: Identify patients recorded as having a penicillamine allergy by running a report in relevant digital systems in primary and secondary care. Clinically review the accuracy of the allergy status and amend accordingly. Ensure allergy records in electronic prescribing and related digital systems that record allergy status are updated. To prevent reoccurrence: Secondary care organisations should ensure allergy guidance and training cover safe recording of allergy status in electronic prescribing systems and related digital healthcare systems, including the need to check and correct allergy status on admission and discharge. Primary care should implement additional checks when staff (especially non-clinical staff) input allergy status into GP systems, for example, consider the need for a clinical review if penicillamine is the stated allergen. All organisations should work with digital system suppliers and user groups to develop and deploy additional built-in mitigations to reduce the likelihood of inadvertent recording of the wrong allergy, such as adding alerts and modifying search terms. Organisations should prioritise the safe deployment of upgrades to their digital systems where suppliers have developed effective mitigations and safety features. The working group should strongly consider producing regular reports on allergy status until assurance has been gained that the issue is resolved.
  21. News Article
    Barcode errors on medicines “pose critical patient safety risks” and could have “potentially fatal consequences,” Henrietta Hughes has warned. The Patient Safety Commissioner for England’s warning comes as a petition has been launched by pharmacists report growing problems with barcode data errors and missing 2D barcodes on UK medicine packs. The issue has been highlighted by several ‘Class 4 medicines defect notifications’ during 2025 that were linked to barcode or labelling problems, including fexofenadine hydrochloride tablets in August 2025, and simvastatin tablets in July 2025. Read full article. Source: The Pharmaceutical Journal (20 November 2025)
  22. News Article
    Wes Streeting has promised to overturn the “jaw-dropping” and “indefensible” inequality in the NHS compensation scheme for babies brain-damaged at birth that means wealthy parents get higher payouts than poorer families. The health secretary said he was “determined” to change the system for dealing with clinical negligence in maternity care, which links the level of damages paid to the parents’ income and background. The existing longstanding compensation scheme includes a payment for future “loss of earnings”, based on what a child might have been expected to earn over the course of their life had they not been harmed at birth. Under a bizarre anomaly, highlighted by The Observer this month, this is calculated by looking at the child’s background, including their parents’ earnings and education. Other “relevant factors” such as the achievements of their siblings can also be taken into account. It means that children of wealthy parents can receive higher damages than those from less privileged backgrounds. The largest packages are typically given to the richest families. Read full article. Source: The Observer (20 November 2025)
  23. Content Article
    This document sets out the government’s 10-year strategy for men’s health in England. It details the government’s vision for men’s health over the next 10 years and actions they are taking now to improve the health and wellbeing of all men and boys in England. This document includes the following strategic framework for the Men's Health Strategy:
  24. News Article
    NHS doctors will be able to use AI tools to help them spot growths which can turn into bowel cancer after the technology was given the green light for use in the health service. Growths in the bowel called polyps are not cancerous, but certain types of polyps can develop into cancer if they are not found and removed early. These can be spotted during a camera test to look inside the bowel, known as a colonoscopy. The National Institute for Health and Care Excellence (Nice) has conditionally approved five new AI tools, which it said can act as a “second pair of eyes” during these examinations. Nice made the draft recommendations after reviewing evidence which suggests they can help doctors find more polyps during bowel examinations. The AI technologies can be used in the NHS while more evidence is collected on them over the next four years, Nice said. Read full article. Source: The Independent, 20 November 2025.
  25. News Article
    Up to 50,000 nurses could quit the UK over the government’s immigration proposals, plunging the NHS into its biggest ever workforce crisis, research suggests. Keir Starmer has vowed to curb net migration, with plans to force migrants to wait as long as 10 years to apply to settle in the UK instead of automatically gaining settled status after five years. The measures, which also include plans to raise foreign workers’ skills requirements to degree level and raise the standards of English language required for all types of visa, including dependents, are seen as an attempt to combat the rise of Nigel Farage’s Reform UK party. A public consultation on the plans is expected imminently, sources said. A survey conducted by the Royal College of Nursing (RCN), seen by the Guardian, found the plans have sparked profound distress among foreign NHS and social care staff. There are more than 200,000 internationally educated nursing staff, about 25% of the UK’s total workforce of 794,000. The government’s proposed changes to indefinite leave to remain (ILR) have triggered alarm, with many now considering leaving the UK for good, the survey suggests. Read full article. Source: The Guardian (20 November 2025)
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