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Found 467 results
  1. 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.
  2. 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
  3. 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.
  4. 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
  5. 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.
  6. 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.
  7. 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.
  8. 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
  9. 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
  10. 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,
  11. 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
  12. 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.
  13. 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.
  14. Content Article
    The Royal College of Physicians of Edinburgh has released a statement on their position on the specific role of the physician associate.
  15. News Article
    Senior doctors are urging MPs to reject government plans to regulate “physician associates”, whose growing use in the NHS has divided the medical profession. The British Medical Association has said that allowing the General Medical Council (GMC) to regulate physician associates (PAs) would “blur the lines” between doctors and non-doctors. Many medics are opposed to the increased use of PAs, who they fear patients will wrongly see as doctors, even though they do not have a medical degree. They have expressed concern that letting the GMC – which regulates doctors – regulate PAs from April, as ministers plan, is “potentially dangerous” because it could confuse the public, diminish the status of doctors, and leave patients at risk of being treated by someone without the appropriate skills. The BMA is running advertisements in the Guardian and on social media asking MPs on a Commons committee examining the plan to vote against it when they consider it on Thursday. “PAs are not the same as doctors, and blurring the lines can have tragic consequences for patients who think they have seen a doctor when they have not,” the adverts say. Read full story Source: The Guardian, 18 January 2024
  16. News Article
    People trying to buy illicit synthetic opioids and sedatives online to treat pain, anxiety and insomnia increasingly risk taking a different drug that has caused dozens of deaths among heroin users, a leading expert has warned. Nitazenes – synthetic and extremely powerful drugs implicated in fatalities of chronic powdered heroin users in Birmingham, Bristol and London in recent months – have been detected in illicit supplies of tablets being sold as diazepam and codeine that appeal to a wider market. New figures released to the Guardian by the National Crime Agency reveal 65 people have died from taking nitazenes in the past six months – more than two a week, while detections in drug supplies have increased more than fivefold in the last two years. “[Nitazenes] are being mixed into heroin but it is also in fake diazepam, fake codeine and the person buying the tablets online is a very different kind of user to a heroin user,” Dr Caroline Copeland, the director of the National Programme on Substance Abuse Deaths said. “It means the risk is much wider.” Read full story Source: The Guardian, 17 January 2024
  17. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.
  18. News Article
    More NHS managers support regulation of their roles than oppose it, despite many fearing its implementation will be unfair or disproportionate, a survey suggests. The trade union Managers in Partnership surveyed NHS managers working at Agenda for Change band 8a and above throughout the UK late last year, collecting 291 responses. Asked whether they “in principle… support professional regulation of NHS managers”, 49% said they supported or strongly supported it. Just 19% said they opposed or strongly opposed, while the remainder were neutral. However, respondents – 22% of whom said they were already covered by a professional regulator, and likely to be nurses, doctors or finance or legal professionals – appeared sceptical about the benefits. Asked whether they thought professional regulation of NHS managers would make processes for raising concerns/whistleblowing better or worse, only 26% said it would be better. 20% said these would get worse, and the remainder said it would be “about the same”. Read full story (paywalled) Source: HSJ, 9 January 2023
  19. News Article
    Patients' lives are being put at risk because it is too easy to buy prescription-only medicines from online pharmacies, a leading pharmacist says. A BBC investigation found 20 online pharmacies selling restricted drugs without checks - such as GP approval. In total, over 1,600 various prescription-only pills were bought during the investigation entering false information without challenge. Regulator the General Pharmaceutical Council says extra checks are needed when selling some drugs online. The BBC's findings highlight the "wild west" of buying medicines on the web, says Thorrun Govind, a pharmacist, health lawyer and former chair of the Royal Pharmaceutical Society. "The current guidance basically tells pharmacies to be robust, but do that in your own way, and we know that under this current system, patients have died," she says. The parents of a woman who died in 2020, after accidentally overdosing on medicines she bought online, are among those calling for stricter rules. Katie Corrigan, from St Erth in Cornwall, had developed an addiction to painkillers after experiencing neck pain. "Katie needed help, she didn't need more medication," says her mum, Christine Taylor. Her GP had stopped supplying the drug after realising she had been allowed to request new prescriptions prematurely and been prescribed too much. Instead, Katie, 38, was able to buy a painkiller and a drug used to treat anxiety from multiple online pharmacies without notifying her GP. The coroner at Katie's inquest confirmed her GP had not been contacted by any of the pharmacies to check the drug was safe for her. In his final report, he said the safety controls were inadequate. Read full story Source: BBC News, 5 January 2024
  20. News Article
    The NHS will start recording harm caused to patients during strike action where exemptions have been rejected by the British Medical Association (BMA). BMA council chair Phillip Banfield yesterday accused NHS England of the “weaponisation” of the strike “derogation” process, saying trusts had this week submitted more of the requests, which would permit some striking doctors to return to work, and were not providing information needed to determine if they were justified. NHS England wrote back to Professor Banfield, insisting it was only trying to prioritise safety, but also saying it would revise its own approach to derogation requests. This will include: asking trusts whose requests were rejected by the BMA “to compile a picture” of the impact on services; reinforcing requirements to report patient safety incidents during strikes and after mitigation requests, so “we can evidence harm and near misses which might have been avoided”. The letter says: “We have consistently asked local medical and other clinical leaders to consider applying to the BMA for patient safety mitigations where they have significant concerns for patient safety that cannot be mitigated through other options available to them, and where they can make a strong evidential case that the return of a limited number of junior doctors would address these risks. “We have done this, in part, because we have received a number of reports over previous periods of action that some teams have been put off seeking patient safety mitigations because of their prior experience of having applications rejected, or not receiving a response in time. We are sure you would agree that this is an unsatisfactory position, and that where patient safety concerns exist, these should always be escalated appropriately.” Read full story (paywalled) Source: HSJ, 4 January 2024
  21. Content Article
    The Right Honourable Sir Anthony Hooper was asked by the General Medical Council (GMC) on 5 September 2014 to conduct an independent review of how the GMC engage with individuals who regard themselves as whistleblowers. Here is the GMC's action plan to address the recommendations in the Anthony Hooper’s review.
  22. Content Article
    In this blog, Lucy Wilkinson, CQC’s Interim Head of equality, health inequalities and human rights, talks about the fundamental link between human rights and delivering safe, good quality care.
  23. News Article
    UK organisations responsible for protecting the public from advertisements of prescription-only drugs are putting patients at risk from the harms of weight loss drugs by not enforcing the law, critics have told The BMJ. The UK’s Human Medicines Regulations 2012 prohibit the advertising of prescription drugs to the general public, and companies that break the rules can be sanctioned with fines, orders to issue a corrective statement, or prosecution. Legal responsibility for regulating advertisements for medicines in the UK rests with the Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of health ministers. But there is also a system of self-regulation with a number of organisations operating their own codes of practice, including the Advertising Standards Authority. But The BMJ has found that the MHRA has not issued a single sanction for prescription drugs in the past five years. And among 16 cases where the MHRA took action by requesting changes to advertisements for weight loss drugs from June 2022 to July 2023, all were triggered by external complaints, not internal mechanisms, and none resulted in sanctions. Read full story Source: The BMJ, 13 December 2023
  24. News Article
    Many people are deeply confused about the growing number of “physician associates” in the NHS and wrongly assume they are doctors, research suggests. Around 4,000 physician associates work in the NHS in England. Ministers and health chiefs plan to increase the figure to 10,000 to help plug widespread gaps in the NHS workforce. However, there is widespread confusion among the public about their role and relationship with fully trained medics, according to a survey commissioned by the British Medical Association (BMA). A quarter of the representative sample of 2,009 people erroneously believed that a physician associate was a doctor, while a fifth made the same mistake about “physician assistants”. Many respondents thought that a physician associate was more senior than a junior doctor, even though only the latter have a medical degree. The expansion of physician associates has prompted a backlash by grassroots medics. They fear patients will be misled into thinking they have seen a doctor despite physician associates not having the same skills and training. The government has moved to try to quell criticism of physician associates by legislating to ensure they are regulated by the General Medical Council (GMC). Read full story Source: The Guardian, 13 December 2023
  25. News Article
    Physician Associates (PAs) and Anaesthesia Associates (AAs) will soon be regulated by the General Medical Council (GMC), improving patient safety and supporting plans to expand medical associate roles in the NHS to relieve pressure on doctors and GPs. The government will lay legislation this week to allow the GMC to begin the process of regulating medical associates, who are medically trained healthcare professionals who work alongside doctors to care for patients. The GMC will set standards of practice, education and training, and operate fitness to practice procedures, ensuring that PAs and AAs have the same levels of regulatory oversight and accountability as doctors and other regulated healthcare professionals. The regulations will come into force at the end of 2024. Physician Associates and Anaesthesia Associates are already making a great contribution to the NHS, supporting doctors to provide faster high quality care for patients. This new legislation paves the way for these professionals to be held to the same strict standards as doctors, boosting patient safety. Regulation and growth of these roles will support plans to reduce pressure on frontline services and improve access for patients. Health and Social Care Secretary, Victoria Atkins, said: "Physician Associates and Anaesthesia Associates are already making a great contribution to the NHS, supporting doctors to provide faster high quality care for patients. This new legislation paves the way for these professionals to be held to the same strict standards as doctors, boosting patient safety. This is part of our Long Term Workforce Plan to reform the NHS to ensure it has a workforce fit for the future." Read Press release Source: The Department of Health and Social Care and The Rt Hon Victoria Atkins MP, 11 December 2023
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