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Found 452 results
  1. News Article
    A doctor working at a women’s health clinic in Melbourne has been suspended as a regulator revealed it was aware of concerns about other practitioners there. The facility’s boss claims it is a “witch hunt”. It follows the death of 30-year-old mother Harjit Kaur, who died in January at the Hampton Park Women’s Clinic after what was described as a “minor procedure”. It was later identified as a pregnancy termination. The Australian Health Practitioner Regulation Agency (Ahpra) has confirmed Dr Rudolph Lopes’ registration had been suspended but did not reveal the reason behind the decision. His registration details show he was reprimanded in 2021 for failing to respond to the regulator’s inquiries. “[The regulator] has received a range of concerns about a number of practitioners associated with the Hampton Park Women’s Clinic,” Ahpra said in a statement. “[The regulator] has established a specialist team to lead a co-ordinated examination of these issues which involve multiple practitioners across a number of professions and across a number of practice locations.” Ahpra chief executive, Martin Fletcher, said he was “gravely concerned by the picture that is emerging.” “We have taken strong action to protect the public while our investigations continue,” Fletcher said. “National boards stand ready to take any further regulatory action needed to keep patients safe. “While the coroner continues to examine the tragic death of a patient, our inquiries are focusing on a wider range of issues that our investigations bring to light.” Read more Source: The Guardian, 15 March 2024
  2. News Article
    A fertility clinic in London has had its licence to operate suspended because of “significant concerns” about the unit, the regulator has said. The Homerton Fertility Centre has been ordered by the Human Fertilisation and Embryology Authority (HFEA) to halt any new procedures while investigations continue. The clinic in east London said there had been three separate incidents highlighting errors in some freezing processes. This resulted in the “tragic loss of a small number of embryos” that either did not survive or became “undetectable”, which means an embryo stored in frozen liquid solution in a container cannot be found during subsequent thawing. The clinic has informed the patients affected and apologised for any distress caused. Homerton Healthcare NHS foundation trust said it began an investigation in late 2023 and immediately made regulators fully aware of it. The HFEA is now conducting its own investigation alongside the trust. In a statement, the clinic said that while the investigators had not been able to find any direct cause of the errors, it had made changes in the unit to prevent the recurrence of such incidents. All staff now work in pairs to ensure all clinical activities are checked by two healthcare professionals, competencies of staff within the unit have been rechecked, and security at the unit has been increased. Read full story Source: The Guardian, 8 March 2024
  3. News Article
    Physician associates should never see ‘undifferentiated’ patients in a GP setting, the BMA has declared in new ‘first of its kind’ guidance. Today, the union has published a national scope of practice laying out how physician associates (PAs) and anaesthesia associates (AA) should work safely in GP practices and secondary care. According to the BMA, the guidance is different from what it describes as the current ‘piecemeal or fragmented approach’ whereby individual organisations set their own guidelines for how PAs should be supervised. In general practice, the guidance said a GP ‘should first triage’ all patients and ‘decide which ones a PA can see’, suggesting annual health checks as an appropriate contact. The union is also clear that PAs ‘must not make independent management decisions for patients’ and must be clear in all their communications that ‘they are not doctors’. Read full story Source: Pulse, 7 March 2024
  4. Content Article
    Landmark national guidance outlining how MAPs (medical associate professionals) can work safely and effectively in the NHS, has been published by the British Medical Association (BMA). The association has unveiled its report Safe Scope of Practice, which sets out in highly detailed terms the responsibilities of MAPs including PAs (physician associates) and AA (anaesthesia associates). Described as a ‘first of its kind’ the report uses a traffic light-style system to illustrate what clinical duties MAPs should be able to carry out, as well as those responsibilities from which they should be prohibited.  The guidance also sets out six general principles for how MAPs should be deployed in primary and secondary-care settings. The guidance comes as the Government continues to press ahead with its plans to have PAs regulated by the GMC despite intense opposition to such a move from the BMA.
  5. News Article
    Medical leaders support a planned increase in the number of physician associates (PA) in the NHS. But the British Medical Association (BMA) is concerned about a new law allowing the General Medical Council (GMC) to regulate PAs, who must be supervised by a fully qualified doctor. The doctors' union says it blurs the lines between doctors and PAs and could risk patient safety. Two families whose relatives were seen by PAs want the roles defined. The NHS has 3,286 PAs, who assist healthcare teams and are not authorised to prescribe or request scans. PAs and anaesthetic associates (AA) qualify after a funded two-year master's degree. They often have a science undergraduate degree, but that is not a prerequisite. Their role includes taking medical histories, conducting physical examinations and developing treatment plans. Like PAs, AAs are healthcare professionals who work as part of a multidisciplinary team with supervision from a named senior doctor. The Academy of Medical Royal Colleges said on Tuesday that it welcomes a push to increase the number of PAs in the NHS, but that it is "vital" that there are clear guidelines on how they are deployed. Read full story Source: BBC News, 5 March 2024
  6. News Article
    Harry Miller was a popular teenager, appreciated for his sharp humour, ability to get on with anyone and eagerness “for the next adventure”. In the autumn of 2017, he was struggling with difficult thoughts and feelings of anger. Harry, who was 14 and lived in south-west London, confided his inner turmoil to friends and family. “I’m just having these anger rages,” he told his mother one day. “It’s like I just go crazy suddenly and I can’t control it. I don’t know what’s going on.” Two years previously, Harry had been prescribed the drug montelukast for his asthma. Unbeknown to his parents, a range of psychiatric reactions had been reported in association with montelukast treatment, including aggression, depression and suicidal thoughts. Harry’s parents, Graham and Alison Miller were not properly warned of the potential side effects. Their son was referred to the NHS child and adolescent mental health services in January 2018, but he missed an appointment because it was sent to the wrong person. On 11 February 2018, Harry was found dead in the family home, with an inquest later recording a verdict of suicide. He was described in a tribute by friends at St Cecilia’s Church of England school in Southfields, south-west London, as a “super star burning brightly”. Two years after his death, his father read an online warning about the adverse reactions involving montelukast by the Medicines and Healthcare Products Regulatory Agency (MHRA). It said these could very rarely include suicidal behaviour. Graham Miller said: “It is an absolute outrage that parents are being given psychoactive substances to give to their children without proper warning of the risk.” This weekend, the MHRA has confirmed that the drug is under review. A montelukast UK action group is calling for more prominent warnings of the drug’s possible side effects. Read full story Source: BBC News, 3 March 2024
  7. News Article
    The medical regulator failed to sound the alarm over Covid vaccine side effects and should be investigated, MPs have said. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving drugs and devices and monitors side effects caused by treatments. But the all-party parliamentary group (APPG) on pandemic response and recovery, an influential group of MPs, has raised “serious patient safety concerns”. It has claimed that “far from protecting patients” the regulator operates in a way that “puts them at serious risk”. Some 25 MPs across four parties have written to the health select committee asking for an urgent investigation. In reply, Steve Brine, the health committee chairman, has said an inquiry into patient safety is “very likely”. In a letter to Mr Brine, the APPG said that there was reason to believe that the MHRA had been aware of post-vaccination heart and clotting issues as early as February 2021, but did not highlight the problems for several months. Read full story (paywalled) Source: The Telegraph, 27 February 2024 Related reading on the hub: Interview with Charlet Crichton, founder of UKCVFamily
  8. Content Article
    On 8 February 2024, Ombudsman, Rob Behrens and Patient Safety Commissioner, Henrietta Hughes, wrote a joint letter to government. Both have regulatory roles to play in improving patient safety and both are struggling to gain headway with the recalcitrant NHS. Supposedly independent of government, this correspondence shows they are in fact totally dependent on government, due to their limited powers writes Della Reynolds in this blog.
  9. News Article
    The House of Lords is being urged to throw out plans for non-doctor associate roles to be licensed by the same body as doctors. Under a planned new law, physician associates (PAs) will be regulated by the General Medical Council (GMC). The British Medical Association (BMA) believes this could lead to patients confusing the different roles, which it says could have "tragic consequences". There are about 3,200 PAs working in GP surgeries and hospitals in England, with 10,000 more planned in the next decade or so. They were introduced to help doctors with their work - examining and diagnosing patients and discussing treatments with them - although PAs are currently unregulated. Unlike doctors, they do not have to hold a medical degree, but they usually have a degree in a life science and have to undertake a two-year training course. The BMA, the union representing doctors in the UK, believes that regulation by the GMC could lead to a "blurring of the lines" between PAs and doctors. In an open letter to the House of Lords ahead of a debate on Monday, the BMA's chairman Prof Phil Banfield said: "PAs are not doctors. They do not hold a medical degree and are not medically trained, despite misleading statements made by some. "We know that patients are already confused about telling the difference between PAs and doctors, and this legislation will make this problem worse. "Keeping the GMC as the regulator exclusively of doctors would mean we retain the clear distinction between doctors and PAs." Read full story Source: BBC News, 25 February 2024
  10. Content Article
    The Government plans to expand physician associate (PA) and anaesthesia associate (AA) roles and to establish the General Medical Council (GMC) as their statutory regulator. There has been concerted opposition to the plans by groups including the Doctors’ Association UK (DAUK) and the British Medical Association (BMA). Earlier this month, the House of Lords sent the draft legislation to the main chamber for proper scrutiny, stating that this was the procedure when an issue "is politically or legally important or gives rise to issues of public policy". In this Medscape article, Dr Sheena Meredith outlines the Government's proposals and why the issue has become so contentious.
  11. Content Article
    In this letter to Health Secretary Steve Brine MP, members of the All Party Parliamentary Group (APPG) on Pandemic Response and Recovery raise serious concerns about the approach of the Medicines and Healthcare Products Regulatory Agency (MHRA) to patient safety. They outline problems within the MHRA that continue to put patients at serious risk of harm. The letter also highlights the role of the Independent Medicines and Medical Devices Safety Review (IMMDS), in its thorough investigation of Primodos, sodium valproate and pelvic mesh in bringing some of these concerns to the fore. It points to recent evidence presented to the APPG that indicates that the MHRA is at the heart of wider endemic failings, with issues uncovered so far being "the tip of a sizeable iceberg of failure." The letter outlines concerns about the following areas: The Yellow Card Scheme Conflicts of interest and transparency History of regulatory failures in the MHRA It calls on the Health and Social Care Select Committee to investigate these issues and make recommendations to the government on: legislative changes as to who is obligated to report adverse drug reactions. funding changes to the MHRA. separation of regulatory approval duties from post marketing pharmacovigilance. more inclusion of patients. greater transparency across the board. proper enforcement of Part 14 of the Human Medicines Regulations 2012.
  12. News Article
    Codeine linctus, an oral solution or syrup licensed to treat dry cough in adults, is to be reclassified to a prescription-only medicine due to the risk of abuse, dependency and overdose, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Codeine linctus is an opioid medicine which has previously been available to buy in pharmacies under the supervision of a pharmacist but will now only be available on prescription following an assessment by a healthcare professional. Since 2019, there have been increasing reports in the media of codeine linctus being misused as an ingredient in a recreational drink, commonly referred to as ‘Purple Drank’. The decision to reclassify the medicine has been made following a consultation with independent experts, healthcare professionals and patients. 992 responses were received. The consultation was launched by the MHRA after Yellow Card reports indicated instances of the medicine being abused, rather than for its intended use as a cough suppressant. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. Codeine linctus is an effective medicine for long term dry cough, but as it is an opioid, its misuse and abuse can have major health consequences." Alternative non-prescription cough medicines are available for short-term coughs to sooth an irritated throat, including honey and lemon mixtures and cough suppressants. Patients are urged to speak to a pharmacist for advice and not to buy codeine linctus from an unregistered website as it could be dangerous. Read full story Source: MHRA, 20 February 2024
  13. Content Article
    As the Cumberlege Review and Paterson Inquiry made clear, having accurate and timely data on treatments and outcomes is critical to patient safety. NHS England is working to strengthen this data by implementing a central database to collect key details of implantable devices at the time of operation. The new Outcomes and Registry Platform will bring existing registries together for the first time and introduce new registries. In a blog for the Patient Safety Commissioner website, Scott Pryde, Programme Director for NHS England’s Outcomes and Registries Programme, and Katherine Wilson, Clinical Steering Group Chair of the programme, discuss the new National Registry of Hearing Implants, a registry specifically for cochlear implants. They highlight the importance of collaboration between patients, clinicians, regulators and medical device manufacturers.
  14. News Article
    An NHS trust has concluded that its former chief executive is not a “fit and proper person” to be on an NHS board, after investigating allegations of sexual harassment and inappropriate behaviour, HSJ has learned. HSJ understands The Robert Jones and Agnes Hunt (RJAH) Orthopaedic Hospital Foundation Trust commissioned a specialist external workplace investigation into Mark Brandreth, which considered serious allegations made about his behaviour during his time as trust chief executive between April 2016 and August 2021. Mr Brandreth is understood to dispute the allegations as well as the investigation’s findings, and is seeking to challenge RJAH’s handling of the complaints and its process for deciding he did not meet the Fit and Proper Person Test. Sources with knowledge of the situation said almost 30 female RJAH staff members came forward to give information to the investigation, but it focused on 12 employees who were willing to give evidence. HSJ has been told that as a result of the investigation, which concluded at the end of last year, the trust’s chair has informed NHSE in writing that it believes Mr Brandreth does not meet the “Fit and Proper Person Test”, implying he should be ruled out of board roles – or roles with equivalent responsibility – at English NHS organisations and adult social care providers. However, the trust, in Shropshire, is not planning to publish its ruling and – with no professional regulation in place for health and care managers and/or board members – it is unclear how effective the conclusion will be if it is not made public. A female staff member told HSJ of her concerns that “nothing is being done”. Read full story (paywalled) Source: HSJ, 21 February 2024
  15. Content Article
    The recent Hughes Report outlined the options for redress for those harmed by valproate and pelvic mesh  In this blog, AvMa's Chief Executive, Paul Whiteing, discusses the trade-off of redress schemes.
  16. Content Article
    The use of AI in medical devices, patient screening and other areas of healthcare is increasing. This Medscape article looks at some of the risks associated with the use of AI in healthcare. It outlines the difficulties regulators face in monitoring adaptive systems, the inbuilt bias that can exist in algorithms and cybersecurity and liability issues.
  17. Content Article
    The National Institute for Health Research (NIHR) awarded researchers from The Open University (OU), Manchester Metropolitan University, the Universities of Oxford, Glasgow and Edinburgh more than £141,000 to expand their world-first study of witnesses’ experience of giving evidence during health and social care workers’ professional conduct hearings. The project, Witness to harm, holding to account: Improving patient, family and colleague witnesses’ experiences of Fitness to Practise proceedings, mainly focuses on cases where there are allegations of harm. This focus should help regulators and employers identify potential improvements to support witnesses whose role in giving evidence is crucial to a fair hearing.
  18. News Article
    Hundreds of frontline NHS staff are treating patients despite being under investigation for their part in an alleged “industrial-scale” qualifications fraud. More than 700 nurses are caught up in a potential scandal, which a former head of the Royal College of Nursing said could put NHS patients at risk. The scam allegedly involves proxies impersonating nurses and taking a key test in Nigeria, which must be passed for them to become registered and allowed to work in the UK. “It’s very, very worrying if … there’s an organisation that’s involving themselves in fraudulent activity, enabling nurses to bypass these tests, or if they are using surrogates to do exams for them because the implication is that we end up in the UK with nurses who aren’t competent,” said Peter Carter, the ex-chief executive of the RCN and ex-chair of three NHS trusts. He praised the Nursing and Midwifery Council (NMC) for taking action against those involved “to protect the quality of care and patient safety and the reputation of nurses”. Nurses coming to work in the UK must be properly qualified, given nurses’ role in administering drugs and intravenous infusions and responding to emergencies such as a cardiac arrest, Carter added. Forty-eight of the nurses are already working as nurses in the NHS because the NMC is unable to rescind their admission to its register, which anyone wanting to work as a nurse or midwife in Britain has to be on. It has told them to retake the test to prove their skills are good enough to meet NHS standards but cannot suspend them. The 48 are due to face individual hearings, starting in March, at which they will be asked to explain how they apparently took and passed the computer-based test (CBT) of numeracy and clinical knowledge taken at the Yunnik test centre in the city of Ibadan. The times recorded raised suspicions because they were among the fastest the nursing regulator had ever seen. Read full story Source: The Guardian, 14 February 2024
  19. News Article
    “What if I told you one of the strongest choices you could make was the choice to ask for help?” says a young, twentysomething woman in a red sweater, before recommending that viewers seek out counselling. This advert, promoted on Instagram and other social media platforms, is just one of many campaigns created by the California-based company BetterHelp, which offers to connect users with online therapists. The need for sophisticated digital alternatives to conventional face-to-face therapy has been well established in recent years. If we go by the latest data for NHS talking therapy services, 1.76 million people were referred for treatment in 2022-23, while 1.22 million actually started working with a therapist in person. While companies like BetterHelp are hoping to address some of the barriers that prevent people from seeking therapy, such as a dearth of trained practitioners in their area, or finding a therapist they can relate to, there is a concerning side to many of these platforms. Namely, what happens to the considerable amounts of deeply sensitive data they gather in the process? Moves are now under way in the UK to look at regulating these apps, and awareness of potential harm is growing. Last year, the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (Nice), began a three-year project, funded by the charity Wellcome, to explore how best to regulate digital mental health tools in the UK, as well as working with international partners to help drive consensus in digital mental health regulations globally. Holly Coole, senior manager for digital mental health at the MHRA, explains that while data privacy is important, the main focus of the project is to achieve a consensus on the minimum standards for safety for these tools. “We are more focused on the efficacy and safety of these products because that’s our role as a regulator, to make sure that patient safety is at the forefront of any device that is classed as a medical device,” she says. Read full story Source: The Guardian, 4 February 2024
  20. News Article
    Concerns have been raised that patients may not be receiving “vital” safety information after HSJ discovered a high-risk medication was frequently not being dispensed as originally packaged. In 2018, the Medicines and Healthcare Products Regulatory Agency asked pharmacies to dispense valproate-containing medications in their original pack where possible, to ensure packages include safety warnings. It also asked manufacturers to produce smaller pack sizes and add pictorial warnings, while pharmacists were additionally asked to add stickered warnings to the outer box of any valproate-containing medication not dispensed in its original packaging. Yet, data obtained via freedom of information requests to the NHS Business Services Authority revealed that while the proportion and number of valproate-containing items dispensed as split packs – as opposed to whole packs – had decreased over the last five years, split packs still accounted for more than half of items dispensed in 2022-23. Emma Murphy, of campaign group In-Fact, said the figures on split pack dispensing were “quite horrifying” and showed “the system is not working”. She added: “Attitudes have got to change – prescribers, GPs etc need to be proactive and warn women of the risks because this isn’t just a side effect, this is harming real babies. As a mum of five affected children, the consequences of valproate in pregnancy on that baby is devastating.” Alison Fuller, of Epilepsy Action, said the high proportion of split packs being dispensed made it “clear why the change in guidance introduced in October 2023 was necessary”, adding: “The manufacturer’s original full pack always contains all the relevant information, which is why it’s the best option for patient awareness.” Read full story (paywalled) Source: HSJ,
  21. News Article
    Unregulated healthcare workers are a risk to the most vulnerable patients, a former victim’s commissioner has warned after The Independent and Sky News uncovered a “horrifying” sexual abuse scandal within NHS mental health services. Dame Vera Baird called for a formal framework for healthcare assistants and support workers, who do not have a mandatory professional register like doctors and nurses and can “come in and go out from one hospital to another” without the same thorough checks. Dame Vera told The Independent that the setup did not lead to a “very safe way of working” because healthcare assistants are “in an environment where they are responsible for vulnerable people”. “If there has been abuse from mental health care assistants who are also agency staff who are coming in and going out from one hospital to another, that needs to be looked at,” she said. “This is not a very safe way of working. Some kind of framework around agency staff seems to be very important [to have].” She warned that sexual predators may go into mental health services and work in units where patients can be “highly sexualised”, prompting a “dreadful combination”. Read full story Source: The Independent, 30 January 2024
  22. Content Article
    Richard von Abendorff, an outgoing member of the Advisory Panel of the Healthcare Safety Investigation Branch (HSIB), has written an open letter to incoming Directors on what the new Health Services Safety Investigations Body (HSSIB) needs to address urgently and openly to become an exemplary investigatory safety learning service and, more vitally, how it must not contribute to compounded harm to patients and families. The full letter is attached at the end of this page.
  23. Content Article
    New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males. These safety and educational materials support the new regulatory measures announced in the National Patient Safety Alert. Healthcare professionals should review the new measures and materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing valproate.
  24. Content Article
    Sharing his own personal experiences of harm, Richard highlights four routes where patients and families can report patient safety incidents to ensure patients' voices can be heard and, most importantly, acted upon.
  25. Content Article
    The Royal College of Physicians of Edinburgh has released a statement on their position on the specific role of the physician associate.
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