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Content Article
RCGP: Physician Associates update (October 2023)
Patient-Safety-Learning posted an article in GP and primary care
Physician associates (PAs) support doctors in the diagnosis and management of patient. They are often employed in general practice as members of the multidisciplinary team, trained in the medical model. This update outlines the Royal College of General Practitioners' (RCGP's) policy position on PAs. The RCGP sees PAs as having an enabling role to play for general practice, but highlights that they must always work under the supervision of GPs and must be considered additional members of the team, rather than a substitute for GPs. -
News Article
Doctor suspended for sterilising woman without permission
Patient Safety Learning posted a news article in News
A consultant gynaecologist who admitted sterilising a woman without her permission has been suspended from practising for 12 months. The woman - known as Patient A - was sterilised by Dr David Sim following an emergency caesarean section. Dr Sim previously admitted that the sterilisation was not necessary to save the woman's life or prevent harm to her health. The procedure took place at Daisy Hill Hospital in Newry in September 2021. On 1 December, the Medical Practitioners Tribunal Service (MPTS) found his fitness to practice was impaired. The tribunal previously heard Dr Sim and the patient had discussed sterilisation twice over a period of years, but the patient had never consented or expressed any wish to undergo sterilisation. When she required the emergency caesarean section, Dr Sim delivered the baby and blocked the patient's fallopian tubes to permanently impair their normal function. Dr Sim previously admitted to the tribunal that this was in violation of the woman's reproductive rights. Read full story Source: BBC News, 5 December 2023 -
Content ArticleGood medical practice has been updated. It sets out the standards of patient care and professional behaviour expected of all doctors in the UK, across all specialties, career stages and sectors. These standards will also apply to physician associates and anaesthesia associates in the future, once they’re regulated by the General Medical Council (GMC). It’s important to familiarise yourself with the updated standards before they come into effect on 30 January 2024.
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EventISO 45003:2021(E) is a guidance document that provides practical advice on managing psychosocial risks in the workplace. This document is designed to help organisations prevent work-related injury and ill health of their workers and other interested parties, and to promote well-being at work. This masterclass will explore the key concepts of ISO 45003:2021(E) and how they apply specifically to healthcare settings. It will discuss strategies for identifying and assessing psychosocial risks, implementing preventive measures, monitoring effectiveness, and promoting well-being in the workplace. The goal is for you to leave this masterclass with a comprehensive understanding of how ISO 45003:2021(E) can be used to manage psychosocial risks in your own organization. You will also have an opportunity to share best practices with colleagues from other healthcare organisations. Who should attend: Clinical staff, Managers, Admin staff, Policy makers and Board members. Key learning objectives: Participants will have a comprehensive understanding of psychosocial risks in the healthcare workplace. Participants will be able to identify preventive measures that can be implemented to manage these risks. Participants will understand the importance of monitoring and evaluating the effectiveness of these measures. Participants will have an increased awareness of their own well-being and safety in the workplace. Participants will have an opportunity to share best practices with colleagues from other healthcare organisations. Register
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Content ArticleThe MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations. This alert is for action by: Integrated Care Boards (in England), Health Boards (in Scotland), Health Boards (in Wales), and Health and Social Care Trusts (in Northern Ireland).
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News Article
Trust leaders raise alarm over ‘mad’ approach to scrutiny of maternity services
Patient Safety Learning posted a news article in News
The management of fragile maternity services is being hamstrung by a lack of clear standards and direction from government and regulators, trust chairs and chief executives have told HSJ. Kathy Thomson, the retiring chief executive of Liverpool Women’s Foundation Trust, told HSJ that a major overhaul of regulation and oversight of maternity care was needed. She warned that trust leaders were confused about what was expected of their stewardship of maternity services. Much of the increased scrutiny of the sector was coming from people with little knowledge and experience of maternity care, and maternity was beset by too many initiatives which “somebody thinks are a nice thing to do”. Ms Thomson’s comments were echoed by a wide range of other NHS leaders (see ’damaging confidence’ below). Ms Thomson told HSJ: “How clear are we nationally about the real ask of maternity services? Are we going to say it’s the ten NHS Resolution (NHSR) safety standards, which are really tough to achieve and which we agonise over? Or is it the CQC standards, because they will often take a different view around very similar issues? “We’ve had that this year after we’ve been assessed as compliant by NHSR, but then had to re-provide evidence after we’ve been criticised by the CQC for something… and then NHSR have written back to say we’re still fully compliant. “So, should you put your time and energy into the NHSR standards, or do you spend the time on the more subjective drivers? Because we can’t keep doing all of it and having different parts of the NHS saying this is what you need to do or expecting something different.” Read full story (paywalled) Source: HSJ, 30 November 2023 -
News ArticleHealth Education England (HEE) and NHS England have warned BMA that its stance on medical associate professionals (MAPs) is impacting NHS relationships and patient confidence. HEE published an open letter to the BMA in response to the union’s call to halt recruitment of MAPs – which includes physician associates (PAs) working in general practice – until regulation is in place. The BMA Council passed a motion calling for a halt to recruitment of MAPs two weeks ago, on the grounds of patient safety. This followed a previous motion to that effect from its GP committee for England earlier this month. Proposing to bring forward a planned meeting with the BMA to discuss the matter, HEE’s letter said: "This continuing public discourse around MAPs is impacting relations between your members and their MAP colleagues, the health and wellbeing of MAPs already working in the NHS, and potentially the confidence of patients." HEE chief workforce, training and education officer Dr Navina Evans and NHS England medical director Sir Stephen Powis argued in the letter that evidence shows "MAPs are safe", and that they "increase the breadth of skill, capacity and flexibility of teams" and reduce workload pressure on other clinicians. ‘Any issues of patient safety identified resulting from MAPs ‘must be addressed in the same way we would any other profession’, the letter added. Read full story Source: Pulse, 27 November 2023
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News Article“Gut-wrenching,” says Lisa McManus. She is looking for words to describe how she and other thalidomide survivors feel ahead of a historic apology by Anthony Albanese for government failings in the tragedy. She is grateful for recognition of the medical disaster and relieved that a decade of advocacy has come to fruition. Around 80 of the 146 recognised survivors will witness the apology in Canberra on Wednesday in what McManus hopes will be “a step in the healing process”. But she is also frustrated that too many others have not lived to see the day. Thalidomide caused birth defects including “shortened or absent limbs, blindness, deafness or malformed internal organs”, according to the Department of Health. The drug was not tested on pregnant women before approval, and the birth defect crisis led to greater medical oversight worldwide, including the creation of Australia’s Therapeutic Goods Administration. Survivors and independent reports have criticised the government of the day for not acting sooner to remove thalidomide from shelves when problems became apparent. McManus leads Thalidomide Group Australia, having lobbied governments for a decade for an apology and better support. She’s “extremely grateful” for the apology, and says many survivors are anxious, excited and nervous – but that the apology itself can’t be the end. “I’m relieved it’s happening, I just can’t say ‘thank you’,” McManus says. “I’m very happy to think it’s here, but it won’t fix things, and I don’t want the government thinking they will deliver this and it’ll all be fine.” Read full story Source: The Guardian, 28 November 2023
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News Article
NHS in crisis as almost half of maternity wards are offering substandard care
Patient Safety Learning posted a news article in News
Almost half of all English maternity units are offering substandard care, making it one of the worst performing acute medical services in the NHS, Byline Times analysis has found. The analysis, based on inspections of English hospitals by the Care Quality Commission (CQC), found that 85 of 172 inspected maternity services in England received ratings of ‘inadequate’ (18) or ‘requires improvement (67) at their latest inspection. Some 65% of maternity wards were given subpar ratings for patient ‘safety’ one of several metrics looked at by the CQC. The findings come after the health regulator began a focused inspection programme of maternity wards last year after the a government review into the Shropshire maternity scandal, which saw 300 babies left dead or brain damaged by shoddy care. In one unit at Gloucestershire Royal Hospital, there was a shortage of midwives, not all medicines practices were safe which “potentially placed women at risk of harm” and serious incidents were not being investigated. The report found a backlog of 215 patient safety incidents that had not yet been looked into, as of March this year. Maria Caulfield, Minister for Women’s Health Strategy, told Byline Times that “maternity care is of the utmost importance to this Government” and stressed they have “invested £165 million a year since 2021 to grow the maternity workforce and improve neonatal services”. “Every parent must be able to have confidence in the care they receive when giving birth, and we are working incredibly hard to improve maternity services, focusing on recruitment, training, and the retention of midwives,” she added. Read full story Source: Byline Time, 28 November 2023 -
Content ArticleThe General Medical Council opened its first office in Scotland in 2003. Here Nicola Cotter, Head of GMC Scotland, looks back at the 20 years since, and just a few of her team’s achievements.
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Content Article
Beyond Compliance website
Patient Safety Learning posted an article in Medical devices (new)
Beyond Compliance is a service to support the safe and stepwise introduction of new or modified implantable medical devices. An independent panel of experts, known as the Beyond Compliance Advisory Group, work with the implant manufacturer to assess the relative risk of any new product, and the rate at which it should be introduced to the market. The service collects data about patients who receive these implants and about their recovery following surgery. This data is made available to clinicians using the implant, to the manufacturer, and to independent assessors from the Beyond Compliance Advisory Group, to provide real-time monitoring of the implant’s performance. The clinicians who agree to joining the advisory group are drawn from the most experienced and respected members of their field. Beyond Compliance is an optional service available to implant manufacturers. The service commenced in the field of joint replacement implants. Following the success of the introduction of Beyond Compliance to Orthopaedic there are now plans for it to be extended for use with other implantable medical devices. -
Content ArticleIn her latest blog, Patient Safety Commissioner Henrietta Hughes discusses MHRA's Yellow Card reporting system and why, until we have mandatory reporting, including for devices that are working as designed, we will continue to see avoidable harm occurring to patients. She stresses that it is vital that the voices and views of patients, clinicians, manufacturer, and health providers participate in the design and delivery of devices.
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Content ArticleIn this opinion piece for the BMJ, Partha Kar looks at the current debate surrounding the role of medical associate professionals (MAPs) in the NHS. He highlights the concerns raised by many that MAPs are “doctors on the cheap” and outlines the reasons for friction between junior doctors and MAPs, which include the issues of pay, training and regulation. He also outlines issues facing locally employed doctors (LEDs), international medical graduates (IMGs) and specialist, associate specialists (SASs) including lack of access to training, supervision and career progression. He makes five suggestions to improve the situation and calls for a pause to consider how these different roles can interact and work together, for the good of both staff and the health service.
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Content ArticleThe latest Care Quality Commission (CQC) report on the state of care in England is far from an encouraging read.1 Although the healthcare system is under serious strain, maternity services are among the areas identified as especially challenged. The problems identified in maternity care, while shocking, come as no surprise. The sector is seeing repeated high profile organisational failures and soaring clinical negligence claims, together with grim evidence of ongoing variation in outcomes, culture, and workforce challenges and inequities linked to socioeconomic status and ethnicity. In this BMJ Editorial, Mary Dixon-Woods and colleagues discuss why it's time for a fresh approach to regulation and improvement.
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Content Article
Professor Jane Somerville, emeritus professor of cardiology at Imperial College, talks about the issues facing doctors who raise concerns about patient safety issues in the NHS. She shares her views on the risks facing doctors who speak up and the ways that healthcare managers treat whistle blowers. She also highlights issues in the employment tribunal system and outlines the need to regulate NHS managers. In the video, Jane mentions the employment tribunal of Dr Martyn Pitman. Since this interview was recorded, Dr Pitman lost the case he brought for retaliatory victimisation. -
News Article
Brazilian butt lift death prompts meeting between UK and Turkey officials
Patient Safety Learning posted a news article in News
UK officials are to meet with counterparts in Turkey following the death of a British woman during so-called Brazilian butt lift surgery at a private hospital in the country’s capital Istanbul. Melissa Kerr, 31, from Gorleston in Norfolk, travelled to the private Medicana Haznedar hospital for the buttock enlargement surgery in 2019. She died at the hospital on the day of the surgery, which involves fat taken from elsewhere on the body being injected into the buttocks. An inquest into her death, which took place place in Norwich earlier this year, heard that Kerr, who was self-conscious about her appearance, was given only “limited information regarding the risks and mortality rate” associated with the operation. Jacqueline Lake, the senior coroner for Norfolk, wrote to the health secretary expressing concern about people travelling overseas for cosmetic surgery. In a written response to Lake, health minister Maria Caulfield confirmed UK officials would be travelling to Turkey to meet with their counterparts. “The intention is to discuss the regulatory framework, and the protections that are in place for UK nationals, and to identify concrete areas where the UK and Turkish authorities should work together to reduce the risks to patients in the future,” Caulfield says in the letter first reported by the BBC. “Specifically, I have noted in your report the lack of standard pre-assessment questions provided to Ms Kerr in Türkiye. “We remain aware countries providing healthcare tourism often conduct pre-assessment checks that may not match UK regulatory standards and we want to encourage all providers treating UK nationals to meet international best practices on pre-operative procedures whenever possible. “Such transparency and standardisation are important to reduce potential risks to patients and improve patient care in the UK and overseas." Read full story Source: The Guardian, 21 November 2023 -
Content ArticleThe Care Quality Commission's new assessment framework will apply to providers, local authorities and integrated care systems. Their ratings and key questions will stay central to their approach. They will continue to use: 5 key questions (safe, effective, caring, responsive and well-led) 4-point ratings scale (outstanding, good, requires improvement and inadequate).
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Content ArticleThe Care Quality Commission (CQC) have published the findings of their five local authority pilot assessments. Assessing how local authorities meet their duties under Part 1 of the Care Act (2014) is a new responsibility for CQC. During the pilots, the CQC looked at nine of their quality statements to assess how well each local authority is meeting its responsibilities. This enabled them to give an indicative rating. Birmingham City Council – indicative rating of good Lincolnshire County Council – indicative rating of good North Lincolnshire Council – indicative rating of good Nottingham City Council – indicative rating of requires improvement Suffolk County Council – indicative rating of good.
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News Article
BMA calls for immediate pause on recruitment of physician associates
Patient Safety Learning posted a news article in News
The BMA has called for an immediate halt to the recruitment of Medical Associate Professionals (MAPs) in the UK including Physician Associates (PAs) and Anaesthetic Associates (AAs). Doctors from across the UK who make up the BMA’s UK Council have passed a Motion which calls for the moratorium on the grounds of patient safety. They want the pause to last until the government and NHS put guarantees in place to make sure that MAPs are properly regulated and supervised. The move follows a number of recent cases in which patients have not always known they were being treated by a physician associate and tragically have come to harm. Professor Phil Banfield, BMA chair of council, said: “Doctors across the UK are getting more and more worried about the relentless expansion of the medical associate professions, brought into sharp focus by terrible cases of patients suffering serious harm after getting the wrong care from MAPs. Now is the time for the Government to listen before it is too late. We are clear: until there is clarity and material assurances about the role of MAPs, they should not be recruited in the NHS. “We have always been clear that MAPs can play an important part in NHS teams, and doctors will continue to value, respect and support individual staff they work with. But MAPs roles and responsibilities are not clearly defined. We are seeing increased instances of MAPs encroaching on the role of doctors; they are not doctors, do not have a medical degree and do not have the extensive training and depth of knowledge that doctors do. As doctors, we are worried that patients and public do not understand what this could mean in respect of the level of experience and expertise in care they receive. “The General Medical Council is the exclusive regulator of doctors in the UK. Adding staff who are not doctors and do not have a medical degree to the GMC register brings into question the competence and qualification of the whole medical profession. The Government may view this as a price worth paying for a shortcut to solving the workforce crisis they have presided over. We know otherwise. GMC regulation of MAPs will only add to the confusion and uncertainty that patients face. “Ministers may hope that by using secondary legislation, which may not even require the vote of MPs, they can avoid raising the alarm. But patients want doctors to remain doctors, regulated by a dedicated body, and they have a right to have confidence in the expert medical care they receive. There must be no doubt that when a patient goes to see a doctor, they are going to see a doctor. This blurring of roles and the confusion caused to patients must stop now.” Source: BMA, 16 November 2023 -
Content ArticleThe government recently published terms of reference for the Thirlwall Inquiry following the crimes committed by former neonatal nurse Lucy Letby while working for the Countess of Chester Hospital NHS Foundation Trust. As well as examining the detail of the offences, the inquiry will also probe whether the trust’s culture, management, governance structures and processes contributed to the failure to protect babies. In the wake of this tragedy, it became apparent that staff had sounded the alarm about Lucy Letby, but that their concerns were not acted on. The case has propelled the issue of NHS management structures and the regulation of managers back into the headlines and made it the subject of political debate.
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News Article
Nursing watchdog to miss target to cut soaring complaints backlog
Patient Safety Learning posted a news article in News
The nursing watchdog will miss its target to tackle a 5,500-case backlog of complaints as referrals hit a record high. The Nursing and Midwifery Council NMC has admitted it won’t hit its pledge to cut the number of unresolved complaints against nurses and midwives to 4,000 by March 2024. The news comes as it faces questions over the way it handles complaints after The Independent revealed a number of serious allegations, including poor investigations that have led to fears of rouge nursing going unchecked. The newspaper exposes have prompted two independent reviews. Details of the first two reviews have been revealed for the first time and will look at: The NMC’s response to whistleblower concerns, including whether they were treated fairly and whether it acted fairly and reasonably. Any evidence of cultural issues which may have impacted the NMC’s response to whistleblowing. Whether concerns raised are substantiated and indicate a decision-making process by the NMC which is insufficient in protecting the public. Evidence of shortcomings in guidance and training. The senior whistleblower whose evidence prompted the review said: “The NMC has refused to change its approach to the investigations into my whistleblowing concerns to allow me to share and explain my evidence without fear of reprisal. I don’t think it is possible to draw safe conclusions about either how I have been treated or the impact of our culture on case work from reviewing only 13 of our current 5,500 open cases, and 6 closed cases and a selection of my emails.” Read full story Source: The Independent, 16 November 2023 -
News Article
Most NHS maternity units not safe enough, says regulator
Patient Safety Learning posted a news article in News
England's healthcare regulator has told BBC News that maternity units currently have the poorest safety ratings of any hospital service it inspects. BBC analysis of Care Quality Commission (CQC) records showed it deemed two-thirds (67%) of them not to be safe enough, up from 55% last autumn. The "deterioration" follows efforts to improve NHS maternity care, and is blamed partly on a midwife shortage. The Department for Heath and Social Care (DHSC) said £165m a year was being invested in boosting the maternity workforce, but said "we know there is more to do". The BBC's analysis also revealed the proportion of maternity units with the poorest safety ranking of "inadequate" - meaning that there is a high risk of avoidable harm to mother or baby - has more than doubled from 7% to 15% since September 2022. The CQC, which also inspects core services such as emergency care and critical care, said the situation was "unacceptable" and "disappointing". "We've seen this deterioration, and action needs to happen now, so that women can have the assurance they need that they're going to get that high-quality care in any maternity setting across England," said Kate Terroni, the CQC's deputy chief executive. The regulator has been conducting focused inspections because of concerns about maternity care. These findings are "the poorest they have been" since it started recording the data in this way in 2018, Ms Terroni said. Read full story Source: BBC News, 16 November 2023 -
News Article
Private health firm Sciensus fails to fix defects that led to UK patient’s death
Patient Safety Learning posted a news article in News
A private health company paid millions by the NHS has failed to fix safety defects that led to the death of a cancer patient, the Guardian can reveal. Three patients were hospitalised and a fourth died when they were given the wrong doses of a powerful chemotherapy drug after a catastrophic IT failure at the medicine manufacturing unit of Sciensus in April this year. The incident, first revealed by the Guardian in July, prompted an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA). Its inspectors found “significant deficiencies” at the Sciensus manufacturing facilities and ordered the partial suspension of its manufacturing licence. However, six months after the IT blunder, Sciensus has not fixed the problems identified by the regulator, according to people familiar with the matter. As a result, the suspension of its licence – originally due to be lifted last month – has been extended until July next year. Sciensus is the UK’s biggest provider of medicines services to NHS and private patients at home. It is contracted by the NHS and other organisations to deliver and administer medicines to more than 200,000 people with conditions such as heart disease, diabetes, dementia, HIV and cancer. Read full story Source: The Guardian, 5 November 2023 -
News ArticleTreatment with isotretinoin for UK patients under 18 years of age must be approved by two prescribers in a series of regulatory changes announced by the Medicines and Healthcare products Regulatory Agency (MHRA) to strengthen the safe use of this drug. Isotretinoin, also known by the brand names Roaccutane and Reticutan, is an effective treatment for severe acne or when there is a risk of permanent scarring. While the drug has helped many patients with severe acne, concerns have arisen among patients and members of the public regarding suspected mental health side effects, including depression, anxiety, psychotic symptoms, and suicide, as well as sexual side effects. Following an expert safety review, the Commission on Human Medicines (CHM) agreed in April of this year to a number of recommendations to strengthen the safe use of the treatment. The safety review concluded that because of gaps in the available evidence, it was not possible to say that isotretinoin definitely caused many of the short-term or long-term mental health and sexual side effects. However, since the individual experiences of patients and families continued to cause concern, the experts recommended that action be taken to ensure patients were made aware of these potential risks and that they were carefully monitored during treatment. "The overall balance of risks and benefits for isotretinoin remains favourable," the authors of the report concluded, but further action should be taken to ensure patients were fully informed about isotretinoin and were effectively monitored during and after treatment, they recommended. Anna Rossiter, programme manager for Medicines for Children at the Royal College of Paediatrics and Child Health, said the information for young people and their families "needs to be written in a format that is easy to understand and must set out the possible side effects that might be experienced". Read full story Source: Medscape, 1 November 2023
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News Article
Warning as patients hospitalised after taking fake Ozempic weight-loss drug
Patient Safety Learning posted a news article in News
People have been hospitalised after taking a fake version of the weight-loss control jab Ozempic, with 369 drugs seized by the UK’s medicines safety regulator. The fake jabs, obtained without prescription through black market suppliers, were seized by the Medicines and Healthcare Products Regulatory Agency. Ozempic, the brand name for semaglutide, and demand for the medicine has contributed to shortages in the product, which is also used for people with type 2 diabetes. The watchdog said a low number of patients had been hospitalised and reported serious side effects, including hypoglycaemic shock. Others ended up in a coma, which indicates the pens may have contained insulin rather than semaglutide. It has urged the public not to buy drugs without a prescription and warned buying prescription-only medicines online “poses a direct danger to health”. Read full story Source: The Independent, 29 October 2023
