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Showing results for tags 'Regulatory issue'.
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Content ArticleThe APPG held their annual general meeting in Parliament. Baroness Cumberlege was re-elected as Co-Chair of the group and in light of Jeremy Hunt’s recent appointment as Chancellor of the Exchequer, Sharon Hodgson MP was elected as Co-Chair, having previously supported the Group as Vice-Chair over the last calendar year. Sharon is is an Officer of the APPG for Valproate and other Anti-Epileptic Drugs in Pregnancy and Vice-Chair of the All-Party Parliamentary Group on Surgical Mesh. The current serving Vice-Chairs were re-elected, with the addition of Baroness Ritchie also joining as Vice-Chair. The Group looked back on a year of significant activity and progress, including the appointment of Dr Henrietta Hughes as the first Patient Safety Commissioner in England, and agreed that a renewed focus on seeking the implementation of redress schemes should be a priority for the Group over the next year.
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Content Article
How can Parliament make health and care safer for all? (4 November 2022)
Mark Hughes posted an article in Others
In this blog for the cross-party think tank Policy Connect, the Professional Standards Authority for Health and Social Care sets out its view on the biggest challenges affecting the quality and safety of health and social care outlined in its report Safer care for all - solutions from professional regulation and beyond. It describes gaps in the wider framework to protect the public highlighted in this report and considers where Parliament and the Government have an opportunity to act to support safer care for all. Related reading Patient Safety Learning: Joining up a fragmented landscape: Reflections on the PSA report ‘Safer care for all’ (12 September 2022) Working together to achieve safer care for all: a blog by Alan Clamp (12 September 2022) -
Content ArticleThe investigation and tribunal hearing of Dr Manjula Arora generated significant anger and anxiety among the medical profession. The case raised once again the perception of a regulatory process lacking in fairness; of a system in which the stakes seem much higher if you are a black and minority ethnic doctor. The General Medical Council (GMC) acknowledged that strength of feeling, making clear it would not oppose Dr Arora’s appeal against the sanction and commissioning a review of the case to understand lessons to be learned for future cases.
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Content ArticleThe General Medical Council (GMC) makes it clear that doctors in the United Kingdom are “personally accountable for [their] professional practice and must always be prepared to justify [their] decisions and actions.” It expects them to comply with a set of obligations, periodically updated, in a series of domains including safety and quality, skills and performance, and maintaining trust. But who is the GMC accountable to? Fundamental questions need to be asked about who health regulators are accountable to, say Martin McKee and Scott L Greer in this BMJ opinion piece.
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Content ArticleIn the UK, regulation prevents prescription-only medications being advertised directly to consumers, but not medical tests. This opinion piece in the BMJ raises concerns about the growing availability and popularity of consumer blood testing. The authors found that dozens of companies are offering health screening for a range of conditions and deficiencies through blood testing kits for use at home. They are often advertised to people with symptoms such as tiredness, low energy, irritability, sleep problems and weight issues. The authors highlight that reading blood test results requires context and training, and results can give people a false sense of security or panic depending on whether they are perceived to be in 'normal' range. They call for guidance on mixing NHS and private care to be updated and recommend that the Care Quality Commission (CQC) should be empowered to appraise private screening and the apps that recommend it.
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Content ArticleWe need a public register to show if healthcare professionals are in the pay of industry – or more patients will suffer, writes Margaret McCartney following the publication of the Independent Medicines and Medical Devices Safety Review. Hospitals in England are meant to publish registers of interest of staff – but a 2016 study shows that only a minority give the details they should. A publicly accessible digital register, updated at least annually and compelled by the regulator, would create transparency and get rid of the huge amount of work that campaigners have had to do to untangle where conflicts lie. Declarations alone can’t sort the problems of conflicted medicine. But a public register would allow us to know whose advice isn’t independent. We will still need to be alert to the unintended consequences of a register, and research will be needed. The UK is lagging behind. Kath Sansom, a journalist who founded the Sling the Mesh campaign, told Margaret: “I had no idea that I couldn’t trust my doctor or surgeon to give the best advice. It is essential that medics declare industry funding.”
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Content ArticleThis short and informative guide, produced by the Quality Care Commission, is for services who may be dealing with challenging behaviour. It includes definitions of the different types of restrictive interventions and directs providers to the evidence they need to provide in order to reassure the regulator that such practice is well governed and safe.
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Content ArticleIn basic terms, a safety management system (SMS) is a formal arrangement for managing, assuring, and improving safety. An SMS is not a single document, it is a framework for managing all risks that arise from running a transport system. It defines roles and responsibilities, sets arrangements for safety mechanisms, involves workers in the process, and ensures continuous improvement. The Railways and Other Guided Transport Systems (Safety) Regulations 2006 (ROGS) introduced the requirement for and content of an SMS. The regulations require most railway operators to maintain an SMS, and hold a safety certificate or authorisation indicating that the SMS has been accepted by the Office of Rail and Road.
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Content ArticleThis article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England.
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Content ArticleWhen something goes wrong in health and social care, the people affected and staff often say, "I don’t want this to happen to anyone else." These 'Learning from safety incidents' resources are designed to do just that. Each one briefly describes a critical issue - what happened, what the Care Quality Commission (CQC) and the provider have done about it, and the steps you can take to avoid it happening in your service.
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Content ArticleEverybody has a right to good care. Much attention is rightly focused on the occasions when people experience poor quality care, but it is also important to recognise where care is good and to celebrate the services that are getting it right. Some care providers do things well through innovative new ways of working, or by doing the basics well. Others can learn from them and solutions should be shared across the system. This publication from the Care Quality Commission (CQC) is purposely focused on celebrating good and outstanding care that CQC's inspectors have seen.
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Content Article'The state of care in NHS acute hospitals 2014 to 2016' presents findings from the Care Quality Commission (CQC's) programme of NHS acute comprehensive inspections. The report captures what has been learned from three years’ worth of inspections. It gives a baseline on quality that is unique in the world – and also shows that it is possible, even in challenging times, to deliver the transformational change that is needed if the NHS is to continue delivering high-quality care into the future.
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Content ArticleThis study in the Journal of the American Medical Informatics Association aimed to evaluate the feasibility of using Unified Medical Language System (UMLS) semantic features for automated identification of reports about patient safety incidents by type and severity. UMLS was compared with results produced by bag-of-words (BOW) classifiers on three testing datasets. The authors found that UMLS-based semantic classifiers were more effective in identifying incidents by type and extreme-risk events than classifiers using bag-of-words (BOW) features.
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EventuntilThe Westminster Health Forum is a division of Westminster Forum Projects, an impartial and cross-party organisation which has no policy agenda of its own. Forums operated by Westminster Forum Projects enjoy considerable support from within Parliament and Government. The agenda: The impact of investigations in the NHS and the priorities of the Healthcare Safety Investigation Branch Progress of improving patient safety in the NHS Maintaining patient safety during COVID-19 - rapid learning to respond to the virus, continuity of care, and adapting care delivery practices Delivering safe care in the NHS - preventing errors, utilising data and technology, supporting the workforce, and promoting high quality leadership Learning from the voice of parents and families How to improve patient safety by reducing unwarranted variation and learning from clinical negligence claims The role of technology in reducing errors, enhancing care, and ensuring safety in remote healthcare and telemedicine Taking forward the National Patient Safety Syllabus and supporting the workforce to deliver care safely during the presence of COVID-19 Learning from harm, reducing the cost of litigation in the NHS, and the impact of COVID-19 Assessing findings from the Independent Medicines and Medical Devices Safety Review The role of the regulator in reducing avoidable harm and informing future practice Register
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Content ArticleSlow-lane logistics shouldn’t stymie fast-track science, says head of UK government’s Vaccine Taskforce, Kate Bingham, in this Nature article. Kate was appointed chair of the UK Vaccine Taskforce in May. The main job of this Taskforce is to identify, manufacture and develop the most promising pandemic vaccines and deliver them rapidly to the populations that need them. COVID-19 is an opportunity to create a permanent system for supplying vaccines for future pandemics, quickly and safely; this process must become as routine and reliable as crafting the yearly influenza vaccine, says Kate. Time and again, outstanding science has been slowed down by the ‘boring stuff’ — practicalities. That includes delays in manufacturing scale-up and legal approvals slowing pivotal US trials of one of my UK company’s potentially life-saving drugs, or progress hampered by logistics, regulatory disagreements and inadequate data disclosure. Often, the problem is not the science or the clinical trials, but the infrastructure. We must take pains now to make sure this does not stall future pandemic vaccines.
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Content ArticleSafety governance refers to the approaches taken to minimise the risk for patient harm across an entity or system. It typically comprises steering and rule-making functions such as policies, regulations and standards. To date, governance has focused on the clinical level and the hospital setting, with limited oversight and control over safety in other parts of the health system. All 25 countries that responded to a 2019 OECD Survey of Patient Safety Governance have enacted legislation that aims to promote patient safety. These practices include external accreditation and inspections of safety processes and outcomes. Safety governance models are also moving away from punishment and shaming towards increased trust and openness. Learning from success as well as failures represents a paradigm shift in safety governance, an approach that has been increasingly adopted in OECD countries.
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Content ArticleWhile approximately one in ten Americans suffers from a rare disease, only 5% of rare diseases have a U.S. Food and Drug Administration (FDA) approved treatment. Congressional and regulatory efforts to stimulate the development of rare-disease treatments, while laudable, have not resolved the fundamental issues surrounding rare-disease treatment development. Indeed, small patient populations, incomplete scientific understanding of rare diseases, and high development costs continually limit the availability of rare-disease treatments. To illustrate the struggle of developing and approving safe rare-disease treatments, this article from While approximately one in ten Americans suffers from a rare disease, only 5 percent of rare diseases have a U.S. Food and Drug Administration (FDA) approved treatment. Congressional and regulatory efforts to stimulate the development of rare-disease treatments, while laudable, have not resolved the fundamental issues surrounding rare-disease treatment development. Indeed, small patient populations, incomplete scientific understanding of rare diseases, and high development costs continually limit the availability of rare-disease treatments. To illustrate the struggle of developing and approving safe rare-disease treatments, this article from Julien B Bannister begins by discussing the approval of Eteplirsen, the first drug approved for treating a rare disease called Duchenne muscular dystrophy. After exploring the current drug regulation system and how this impacts the availability of rare-disease treatments, he examines the 21st Century Cures Act's patient experience data provisions and the pending Trickett Wendler Right to Try Act. Ultimately, the unmet therapeutic needs of rare-disease patients can be met while protecting patient safety. Bannister reasons that, if carefully implemented, the 21st Century Cures Act and the Trickett Wendler Right to Try Act could work in tandem to safely facilitate patient access to rare-disease treatments.
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Content ArticleIn Part 8 of the 'Why investigate' blog series, Martin Langham takes a look at the hub's error trap gallery and explains why when we conclude it's an error trap we are missing the bigger picture.
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Content ArticlePeter Walsh, Chief Executive of Action against Medical Accidents (AvMa), guest blogs for the Professional Standards Authority, setting out the key priorities AvMa would like to see as part of regulatory reform to ensure patients have a voice.
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Content ArticleThe Care Quality Commission (CQC) has published the second report of Professor Glynis Murphy’s independent review of its regulation of Whorlton Hall between 2015 and 2019. CQC commissioned Professor Murphy to conduct an independent review to look at whether the abuse of patients at Whorlton Hall could have been recognised earlier by the regulatory process and to make recommendations for how CQC can improve its regulation of similar services in the future. In addition, CQC asked Professor Murphy to conduct a review of international research evidence to look at how abuse is detected within services for adults with a learning disability and autistic people and how such detection can be improved. The first report of Professor Murphy’s review made a number of recommendations for CQC to strengthen its inspection and regulatory approach for mental health, learning disability and/or autism services. This second report outlines the progress that CQC has made to implement the recommendations. This includes publication of the final report of its review of restraint, seclusion and segregation; work on closed cultures and the development of a tool for rating support plans.
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Content ArticleIn the summer of 2019, following a televised Panorama programme showing abusive care of people with learning disabilities and/or autism in Whorlton Hall (an independent hospital in the north of England), the Care Quality Commission (CQC) requested an independent review of its inspections of Whorlton Hall. Professor Glynis Murphy was appointed to conduct the review.
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Content ArticleThe Canadian Patient Safety Institute's (CPSI's) strategic plan for 2018-2023 promises to lead health system-level strategies to ensure safe healthcare by demonstrating what works and by strengthening commitment. Patient safety incidents in total (acute care and home care combined) are the third leading cause of death, behind cancer and heart disease with just under 28,000 deaths across Canada (2013). This is equivalent to such harm events occurring in Canada every one minute and 18 seconds, resulting in a death every 13 minutes and 14 seconds. Strengthening Commitment for Improvement Together: A Policy Framework for Patient Safety, focuses on key policy levers available to influence system changes.
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Content ArticleIt has been 20 years since the report An Organisation With A Memory drew attention to the problem of adverse health events in the NHS. Since then, patient safety has blossomed as an explicit policy focus of the NHS (and other health systems worldwide), bringing with it new regulatory and organisational arrangements, safety campaigns, reporting and alerting systems, and other measures intended to enshrine patient safety at the heart of health care. At this juncture, it is useful to reflect on developments over the past few decades. The following timeline has been put together by myself, historian Christopher Sirrs, as part of the Wellcome Trust project 'Hazardous Hospitals: Cultures of Safety in NHS General Hospitals, c.1960-Present.' Members of the Patient Safety Learning hub are invited to comment or reflect on the timeline, highlighting innovative safety campaigns, research projects, or other initiatives which have promoted patient safety in the UK. More broadly, the project is interested to hear from anyone with direct experience of promoting safety in NHS hospitals, such as patient safety managers, clinical risk managers, or members of official bodies. Further details can be found on the project website.
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Content ArticleThis comprehensive systematic review, produced by the General Medical Council) examined the prevalence, severity and key types of preventable patient harm.
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Content ArticleIn her blog for the Professional Standards Authority, Sarah Seddon talks about her personal experience as a patient going through the fitness to practise process. She outlines her thoughts on the key considerations that she believes regulators should take into account to help 'humanise' the process. "I was known as ‘Woman A’. To me, this embodies the entire impersonal, inhumane world of fitness to practise. I wasn’t a person with needs, thoughts and feelings; I wasn’t a bereaved mum; I wasn’t a professional anymore but simply a piece of evidence."
