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Found 473 results
  1. Content Article
    In this opinion piece, Kath Sansom, founder of Sling the Mesh, looks at why an audit of pelvic mesh outcomes due to be published in April 2023 has again failed to capture the true extent of the harm caused by the procedure. She outlines why the approach taken by the Government and NHS Digital was flawed and why it is so important to understand both the proportion of women who have experienced harm as a result of the procedure, and the nature of their injuries and side effects.
  2. Content Article
    Victoria Vallance, Director of Secondary and Specialist Care, provides an update on the Care Quality Commission (CQC)’s ongoing national maternity inspection programme and offers early insight into the emerging themes, including good practice examples to support wider learning across all trusts.
  3. Content Article
    In this blog, TranspariMED Founder Till Bruckner reviews The Truth Pill: The Myth of Drug Regulation in India, a new book that looks at problems with the medications regulatory system in India. The book's authors, Dinesh S. Thakur and Prashant Reddy T, draw on in-depth legal and regulatory analyses, numerous case studies and responses to hundreds of Freedom of Information requests to document glaring gaps in India’s legal framework and severe shortcomings in regulatory oversight and enforcement.
  4. Content Article
    Hospitals and other medical organisations are being hit by a rising number of cyberattacks; ransomware strikes on healthcare doubled annually between 2016 and 2021, according to a study published in December in the Journal of the American Medical Association. After a cyberattack, hospitals are forced to cancel procedures, reroute patients to other facilities and resort to pen-and-paper record-keeping. In this article, Wall Street Journal reporter James Rundle looks at how cyberattacks and a regulatory push are increasing the pressure on medical device manufacturers to improve the security of their products.
  5. Content Article
    Dr Freya Smith, a Specialty Trainee in General Practice, reflects on the sinister and toxic side of medicine, using the recent Paterson and vaginal mesh scandals to demonstrate how patients have been let down by the system. In an honest and personal account, she shares with us the horror and sadness she felt at learning of these scandals and how she aspires to keep her future patients safe.
  6. Content Article
    Twenty-six doctors were referred to the General Medical Council by a single hospital trust - no further action taken. BBC Newsnight investigated.
  7. News Article
    The National Institute for Health and Care Excellence (NICE) has decided not to recommend Evusheld for adults who are unlikely to have an adequate immune response or cannot have the vaccine against Covid-19, citing a lack of evidence that it is effective against circulating variants. However, it is still reviewing whether the antibody drug could be used to prevent covid-19 infection in adults at the highest risk of severe illness, including people with immunodeficiency, people who have had a solid organ transplant, and people with cancer. NICE’s director of medicines evaluation, Helen Knight, acknowledged that the decision would be “disappointing for the many thousands” of vulnerable people who “continue to significantly modify their behaviour to avoid infection. Commenting on NICE’s decision, Lennard Lee, senior clinical research fellow at the University of Birmingham, said, “While it’s right for NICE to ensure that treatment options are based on the best possible evidence for their safety, efficacy, and cost effectiveness, it must be recognised that those who remain extremely vulnerable to covid need to be prioritised in trials akin to those early days of the pandemic to find treatments fit for them. “Otherwise, we run the risk of consigning half a million people to continue to live in 2020, stuck in their homes, not able to see their families and friends for fear of infection with no protection.” Read full story Source: The BMJ, 16 February 2023
  8. News Article
    The chief executive of pharma group Novo Nordisk has apologised for breaking the UK industry code by failing to disclose its sponsorship of obesity and weight management training courses for healthcare professionals that also promoted its weight loss drug. The webinars, which were viewed by thousands of healthcare professionals, preferentially included positive information about Novo’s weight loss drug Saxenda, which the self-regulatory watchdog deemed a “disguised” large-scale promotional campaign. The industry self-regulatory body published a strongly worded reprimand last year, saying it was “concerned about the company’s compliance culture . . . internal governance systems and processes, and a perceived naivety and lack of accountability from Novo Nordisk”. It also said it was concerned about “the potential impact on patient safety” because the webinars, which were run by a third-party provider but sponsored by Novo, showed a “lack of balance” in how they compared the side effects of Saxenda and its competitors. Read full story (paywalled) Source: The Financial Times, 12 February 2023
  9. News Article
    Most health claims on formula milk products have little or no supporting evidence, researchers have said, prompting calls for stricter marketing rules to be introduced worldwide. Millions of parents use formula milk in what has become a multibillion-dollar global industry. But a study published in the BMJ has found most health and nutritional claims about the products appear to be backed by little or no high-quality scientific evidence. “The wide range of health and nutrition claims made by infant formula products are often not backed by scientific references,” said Dr Ka Yan Cheung and Loukia Petrou, the joint first co-authors of the study. “When they are, the evidence is often weak and biased.” Dr Daniel Munblit and Dr Robert Boyle, senior co-authors for the study, added: “There is a clear need for greater regulation and oversight to ensure that these claims are supported by sound scientific evidence and to protect the health and wellbeing of our youngest and most vulnerable populations.” Read full story Source: The Guardian, 15 February 2023
  10. Content Article
    This summary of how a National Patient Safety Board (NPSB) will benefit patients and families was coproduced by the NPSB Advocacy Board with Patients for Patient Safety US. It outlines how the NPSB would ensure more comprehensive learning from patient safety incidents, ensure patients and families have a core role in governance and priority setting and that data is used to better understand patient safety in the US.
  11. Content Article
    This Sky News investigation looks at one of the pharmaceutical industry's biggest scandals—the hormone pregnancy test Primodos which was prescribed to pregnant mothers in the UK between 1958 and 1978. Primodos was found to lead to birth defects, miscarriages and stillbirth, and regulatory failings led to avoidable harm to thousands of babies.
  12. Content Article
    This blog by Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson, looks at safety and regulatory issues associated with Essure, a permanent contraceptive implant. Essure anchors inside the fallopian tubes and reacts with the tissues, causing them to become inflamed and scarred. The resulting scar tissue then blocks the tubes off, intending to prevent fertilisation. The devices are about 4cm long and contain a stainless steel, nickel and titanium inner coil and an expanding outer coil containing iron, chromium and tin. Essure has been shown to cause allergic reactions, lifelong inflammatory reactions and internal injuries. The authors examine how Essure came to be approved for use in the USA, the UK and the rest of Europe, highlighting regulatory failings and conflicts of interest with the medical tech industry. They also highlight how pressure from women harmed by Essure resulted in its use being banned in several countries. The blog then describes ongoing efforts to access UK data on reports of adverse events due to Essure that are held by the Medicines and Healthcare Regulations Agency (MHRA). Freedom of Information requests for this data have been denied.
  13. Content Article
    The National Institute for Clinical Excellence (NICE) updated their guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. This review in the journal Diabetes, Obesity and Metabolism aimed to compare regulatory standards for CGM in the UK and Europe, with those applied in the USA by the Food and Drug Administration (FDA) and in Australia by the Australian Therapeutic Goods Administration (TGA). It describes the processes in place and highlights that the criteria applied in the UK for assessing accuracy do not translate into real-life performance. The authors offer a framework to evaluate CGM accuracy studies critically and conclude that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications applied in the EU can have discrepancies. They argue that the UK can bolster regulation, but that this need to be balanced to ensure that innovation and timely access to technology for people with type 1 diabetes are not hindered.
  14. News Article
    The government has rejected an urgent call by MPs to bring in a new licensing regime for non-surgical procedures such as Botox injections, chemical peels, microdermabrasion and non-surgical laser interventions. Ministers also rejected recommendations by the House of Commons Health and Social Care Committee to make dermal fillers available as prescription only substances—as Botox is—and to bring in specific standards for premises that provide non-surgical cosmetic procedures. The government also rejected several recommendations aimed at tackling obesity—including a dedicated eating disorder strategy, annual health and wellbeing checks for every child and young person, and restrictions on buy-one-get-one free deals for foods and drinks high in fat, salt, or sugar. Read full story Source: BMJ, 2 February 2023
  15. News Article
    A highly toxic chemical compound sold illegally in diet pills is to be reclassified as a poison, a government minister has said. Pills containing DNP, or 2,4-dinitrophenol, were responsible for the deaths of 32 young vulnerable adults, said campaigner Doug Shipsey. His daughter Bethany, from Worcester, died in 2017 after taking tablets containing the chemical. The deaths were down to a "collective failure of the UK government", he said. DNP is highly toxic and not intended for human consumption. An industrial chemical, it is sold illegally in diet pills as a fat-burning substance. Experts say buying drugs online is risky as medicines may be fake, out of date or extremely harmful. Mr Shipsey said he had targeted the minister following the death of another young man who had taken the drug sold as a slimming aid. Prior to this, following the inquests of dozens of young people who had suddenly and unexpectedly died from DNP toxicity, the government had "ignored numerous coroners reports" to prevent future deaths, he said. "So, at last after 32 deaths and almost six years of campaigning, the Home Office (HO) finally accept responsibility to control DNP under the Poisons ACT 1972," he added. Read full story Source: BBC News, 28 January 2023
  16. Content Article
    This episode discusses the role NICE plays in patient safety. The guests are: Professor Kevin Harris, senior responsible office for patient safety at NICE, and clinical advisor to the Interventional Procedures Programme and Professor Jane Blazeby, Professor of Surgery at University of Bristol.
  17. News Article
    A “most accomplished fraudster” was paid between £1m and £1.3m by the NHS during the nearly two decades she posed as a qualified doctor after forging a degree certificate, a court has heard. Zholia Alemi, believed to be 60 years old, worked as a psychiatrist in the UK for 19 years after claiming to have qualified at the University of Auckland in New Zealand, a trial at Manchester crown court heard. The defendant is accused of 20 offences, including forgery and fraud, which she denies. The jury heard Alemi’s case was that she was appropriately qualified and documents demonstrating her qualifications were genuine. She denies 13 counts of fraud, three counts of obtaining a pecuniary advantage by deception, two counts of forgery and two counts of using a false instrument. Read full story Source: The Guardian (paywalled)
  18. News Article
    The FDA is greenlighting the drug Leqembi after it appeared to slow cognitive decline in some early stage Alzheimer’s patients in spite of some potential risks. In this video, Kristen Dahlgren has more details about findings from the clinical trial. Watch full story Source: NBC News, 7 January 2023
  19. News Article
    NHS trusts in England have increased recruitment from low-income “red list” countries to make up for the post-Brexit loss of EU staff, despite a code of practice to safeguard health services in those developing countries. A report by the Nuffield Trust thinktank also identified shortages in vital specialist areas since Brexit, including dentistry, cardiothoracic surgery and anaesthesiology. It found that Brexit is still causing issues with the supply of medicines in Northern Ireland despite a change in the arrangements put in place by the EU last April. The report says that since 2021, the Northern Ireland protocol obliging EU trade rules to be followed in the region has led to a different set of medicines being available compared with the rest of the UK. Of the 597 products specifically approved by the Medicines and Healthcare products Regulatory Agency since Brexit, “only eight were also approved for Northern Ireland under the same name and company”. It also found that since 2021, 52 products had been granted marketing authorisation for Northern Ireland but not in Great Britain under the EU approvals system, including a painkiller from the Slovenian company Sandoz Farmacevtska Druzba designed to stop people dying from opiate overdoses. The Democratic Unionist Party (DUP) described the report as “deeply alarming”. Read full story Source: The Guardian, 7 January 2023
  20. Content Article
    In December 2022, the All Party Parliamentary (APPG) for Whistleblowing heard evidence on the state of the NHS following the recent report on the avoidable deaths and life changing injuries caused to mothers and babies at the East Kent Trust. The culture at this hospital was described as one where “everyone knew the problems” and where whistleblowers were “thrown to the lions”. A culture attributed to 45 of the 65 baby deaths reviewed.  This blog first appeared on the Whistleblowers UK website in December 2022.
  21. News Article
    Some integrated care systems (ICSs) still require “an awful lot of control” from the centre, Patricia Hewitt has told HSJ, tempering any expectations that her government-commissioned review will bring about a wholesale roll-back of national performance management. The former Labour health secretary, who is also an integrated care board chair, was commissioned in November by chancellor Jeremy Hunt and health secretary Steve Barclay to review ICS autonomy and accountability. In her first interview since she started the work, Ms Hewitt also said: She had not ruled out “legislative tweaks” as a result of her review, but emphasised ICBs already had substantial ”soft power”; Some ICBs were still indulging in ‘old school’ combative behaviour, and stressed they should not become ‘top down regulators’; She wanted to “catalyse” the Care Quality Commission’s move to focus on systems and integration; and It appeared there were probably too many non-clinical support staff in the NHS, but not too many managers, and she would look more closely at the issue. Read full story Source: HSJ, 30 December 2022
  22. News Article
    The reform of the UK’s Medical Device regulation offers a golden opportunity to drive innovation and growth in the UK’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach. But there is an urgent need for action to ensure we do not lose this opportunity. Senior members of the Life Sciences Council, Will Quince MP, Minister of State at the Department of Health and Social Care, Dr June Raine, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) and Peter Ellingworth, CEO, Association of British HealthTech Industries (ABHI) have today announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Acknowledging the Chancellor’s priorities of stability and growth supported by regulatory reforms, and the importance of the success of the system to UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system. The advisory group has agreed that aligned proposals will be published on three priority areas: international recognition routes for innovation system capacity. Read full press release Source; Gov.UK, 16 December 2022
  23. Content Article
    This editorial in the Journal of Patient Safety and Risk Management reflects on the achievements of the organisation Action Against Medical Accidents (AvMA) over the past 40 years and looks at the emerging role of Patient Safety Learning amongst organisations working for patient safety. Helen Hughes, Chief Executive of Patient Safety Learning, and Albert Wu, Editor-in-chief of the journal, reflect on the purpose and value of patient safety charities and not-for-profit organisations, highlighting the ways in which they channel and champion the patient voice and campaign to address specific areas of recurrent harm. They discuss the vital nature of the patient perspective in driving safety improvements in healthcare, and look at how these organisations amplify this. They also talk about the role of Patient Safety Learning and what it is doing to both drive system change at policy level, and share widely the knowledge of risk and good practice for safer care. They discuss the ways in which Patient Safety Learning delivers its aim to "listen to and promote the voice of the patient safety front line - patients, families and staff.”
  24. Event
    until
    This conference from the Westminster Health Forum will focus on the future for diagnostics and medical devices in England - looking at developments and next steps for strategy and regulation. The discussion takes place in the context of the upcoming MedTech strategy from DHSC, and will be an opportunity to examine priorities for improving flexibility and transparency in MedTech supply and procurement, securing value for money, and supporting the adoption of innovation in healthcare settings. Delegates will discuss implementation of the MHRA update to the regulation of medical devices, as well as priorities for safety, assessment and contribution to better patient outcomes. Overall, areas for discussion include: Regulation and evaluation: transition to the new medical device regulations and the updated evaluation process - implementation of the new MHRA medical device regulation proportionate regulation and support for businesses - addressing capacity constraints of authorisation of Approved Bodies patient access: establishing new device frameworks for supporting adoption of innovative medical technology - supporting patient access to devices currently on the market the supply chain: flexibility, transparency and responsiveness in the procurement and supply of medical technology collaboration between healthcare providers and suppliers - engaging healthcare professionals in procurement. Supporting the NHS: workforce efficiency and earlier diagnosis - innovation in diagnostic pathways to address backlogs and wait times - improving patient outcomes and the speed of recovery the role of the new community diagnostic centres - encouraging adoption of new diagnostic methods in the centres and across the NHS. Register
  25. News Article
    More than 10,000 patients have been given a faulty knee replacement which doubles the risk of joint failure, The Telegraph has disclosed. The implant, which has been in use since 2003, was withdrawn from the market by its manufacturer in October. The Telegraph has learnt that UK health regulator the Medicines and Healthcare products Regulatory Agency (MHRA) is now preparing to issue a field safety notice, prohibiting its use. Available across multiple NHS trusts, the implant, manufactured by Zimmer Biomet, a US firm, has been shown to fail in up to 7% of patients after ten years - twice the accepted failure rate of 3.5% set by the National Joint Registry. One study found the failure rate to be much higher at 17.6% - more than five times as high as the accepted level. This can have catastrophic consequences for patients, many of whom are elderly, as undergoing a second knee replacement operation poses a much greater risk. The knee replacement, called the Nexgen, is part of a family of Zimmer Biomet implant devices with 88 possible variants. In total, these have been given to over 183,000 people in England, Wales and Northern Ireland, and more than five million worldwide. Of these variants, three combinations have been proven to place patients at a dangerously high risk of joint failure. Read full story (paywalled) Source: The Telegraph, 5 December 2022
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