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Showing results for tags 'Regulatory issue'.
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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 -
Content ArticleIn this article Sir Bernard Jenkin, Member of Parliament for Harwich and North Essex, considers the role of new statutory body to investigate patient safety concerns across England to improve NHS care at a national level, the Health Services Safety Investigations Body (HSSIB). He talks about the new “safe space” powers of the organisation and its intended role in the healthcare system.
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News ArticleValproate-containing medicines will be dispensed in the manufacturer’s original full pack, following changes in regulations coming into effect on Wednesday 11 October 2023. The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance for dispensers to support this change. Following a government consultation, this change to legislation has been made to ensure that patients always receive specific safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are contained in the manufacturer’s original full pack. These materials form a key part of the safety messaging and alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy. The changes follow a consultation on original pack dispensing and supply of medicines containing sodium valproate led by the Department of Health and Social Care (DHSC), in which there was overwhelming support for the introduction of the new measures, to further support safety of valproate-containing medicines. Minister for Public Health, Maria Caulfield, said: “This safety information will help patients stay informed about risks of valproate, and I encourage all dispensers of valproate to consult the new guidance carefully. “This continues our commitment to listening and learning from the experiences of people impacted by valproate and their families and using what we hear to improve patient safety.” Read full story Source: MHRA, 11 October 2023
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News ArticleThousands of complaints made against nurses and midwives were rejected by the watchdog without investigation last year as it battles a huge backlog amid concerns rogue staff are being left unchecked. The Nursing and Midwifery Council has rejected hundreds more cases a year since 2018, including 339 where nurses faced a criminal charge, 18 for alleged sexual offences and 599 over allegations of violence in 2022-23, according to data shared exclusively with The Independent. The new figures come after The Independent revealed shocking allegations that nurses and midwives accused of serious sexual, physical and racial abuse are being allowed to keep working because whistleblowers are being ignored and that the NMC was failing to tackle internal reports of alleged racism. And now, a new internal document, obtained by The Independent, reveals more staff have come forward to raise concerns since our expose. Former Victims’ Commissioner Dame Vera Baird KC said the backlog of complaints was “worryingly high” and called for urgent action to tackle it. Read full story Source: The Independent, 19 October 2023
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News Article
NMC ‘toxic culture’: regulator appoints barrister to investigate
Patient Safety Learning posted a news article in News
An employment and equality lawyer will lead investigations into claims of racism, sexism and toxic culture at the Nursing and Midwifery Council (NMC). The nursing regulator has appointed Ijeoma Omambala KC to review claims that fitness to practise cases have been mishandled, especially those involving racism, discrimination, sexual misconduct and child protection. She will lead a concurrent investigation into how complaints about allegations were handled. "I’m sorry anyone has concerns about our culture, and the regulatory decisions we take. We’re committed to a rigorous, transparent and independent response". Read full story (paywalled) Source: Nursing Standard, 17 October 2023 -
News ArticleThe government ignored expert warnings to regulate physician associates (PAs) for more than two decades and now patients have come to harm, doctors have said. A leading doctors’ union blamed the “dithering of successive governments” for the “extremely dangerous” increase in PAs carrying out doctors’ duties. Jeremy Hunt, then health secretary, told a House of Lords committee in 2016 that the government was “committed to introducing legislation for regulatory reform” and it was “a question of finding a parliamentary slot”, citing Brexit debates as a cause of the delay. Seven years, two consultations and at least two deaths later, regulation of PAs is still a year away, following a series of delays that the Faculty of Physician Associates itself has called “disappointing”. Dr Matt Kneale, co-chair of the Doctors’ Association UK, told The Telegraph the lack of regulation “poses a significant risk to both patient safety and the overall standard of care within the NHS”. He said supervising doctors taking on the accountability for PA was not a “tenable long-term solution”. “Regulation could and should have been introduced earlier to prevent instances of patient harm. The lack of action for over two decades is concerning and requires urgent action,” he added. Read full story (paywalled) Source: The Telegraph, 14 October 2023
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News Article
Several hospitalised in Austria after using suspected fake diabetes drug
Patient Safety Learning posted a news article in News
Several people have been admitted to hospital in Austria after using suspected fake versions of Novo Nordisk’s diabetes drug Ozempic, the country’s health safety body has said, the first report of harm to users as a European hunt for counterfeiters widened. The patients were reported to have suffered hypoglycaemia and seizures, serious side-effects that indicate that the product contained insulin instead of Ozempic’s active ingredient semaglutide, the health safety regulator Bundesamt für Sicherheit im Gesundheitswesen (BASG) said on Monday. The European Medicines Agency (EMA) warned last week that pens falsely labelled as Ozempic were in circulation, and Austria’s criminal investigation service said on Monday that the fake injection pens could still be in circulation. The Danish maker of the drug, Novo Nordisk, has warned of a rise in the online offers of counterfeit Ozempic as well as its weight-loss drug Wegovy, both based on semaglutide. “It appears that this shortage is being exploited by criminal organisations to bring counterfeits of Ozempic to market,” said BASG. Read full story Source: The Guardian, 24 October 2023 -
News Article
Confirm there is no plan to ‘replace doctors’, NHSE told
Patient Safety Learning posted a news article in News
The medical regulator has told NHS England to ‘directly tackle’ a perception there is a plan to replace doctors with physician associates amid an ‘intense’ debate about their future. General Medical Council chief executive Charlie Massey wants NHS England and health systems in the devolved nations to address several issues surrounding the expansion of medical associate roles. This follows intense debate over recent weeks, including multiple media reports of safety incidents where the involvement of physicians and anaesthesia associates has been questioned. The debate has been partially prompted by ambitions in the long-term workforce plan to increase their numbers, and the impact this would have on post-graduate medical training. Last week almost 90% cent of Royal College of Anaesthetists members voted to pause the rollout of anaesthesia associates, after an extraordinary general meeting. This prompted NHSE leaders to stress to trusts that associates should be working within established guidelines and have appropriate supervision. In response, Mr Massey has written to NHSE, calling for it to: “Directly tackle the perception that there is a plan for the health services to ‘replace’ doctors with PAs or AAs by convening and leading a system-wide discussion on an agreed vision for these roles.” Read full story (paywalled) Source: HSJ, 25 October 2023 -
News Article
Plan to pump 10,000 fake doctors into the NHS is insane and dangerous
Patient Safety Learning posted a news article in News
You might not have heard of a ‘physician associate’ - and that’s not your fault. They probably won’t tell you. A physician associate walks and talks like a doctor, but they are no replacement for one. To become a physician associate you need to complete a two-year postgraduate course or three-year apprenticeship. But despite much less learning than the five years a junior doctor must undergo to be qualified, they are often paid more than them. Which is why the government’s plan to flood the NHS with 10,000 more of them over the next 15 years doesn’t make any sense. There’s certainly no money-saving aspect. This is simply another corner-cutting exercise to quickly plug gaps in a struggling NHS that will put patients at risk. Far from saving doctors work (their original purpose), they often create more. Physician associates are unregulated so cannot be held accountable for their mistakes, meaning doctors must recheck any critical decisions they make. Critical decisions are made quite frequently in hospitals. But they’re not just overstretching doctors and creating more work; they’re harming patients. A recent Daily Mail investigation has found brain bleeds misdiagnosed as inconsequential headaches and lung disease mistaken for a chest infection. Doctors say they are “increasingly concerned” by this. Read full story Source: LBC, 16 October 2023 -
News ArticleRegulation of managers must not lead to a disbarring process without also introducing ”developmental” and supportive measures, NHS England’s national patient safety director has said. Speaking at HSJ’s Patient Safety Congress, Aidan Fowler was asked whether NHS board members and managers should be regulated, amid calls for this in the wake of the Lucy Letby scandal. He said: “I think there are pros and cons to regulation… What I would say is that you just have to be cautious that you do not lead to a disbarring process without the developmental side of regulation, and the support side of regulation. For staff, to support them to do a good job. “We have seen that there is a gap in patient safety training for boards, which we need to work on, for them to understand and to encourage them to talk about it more. “I think there is a developmental part of regulation, which is really important… in any discussion. I know because we are already having discussions around it. That is a key part to pay attention to.” Read full story (paywalled) Source: HSJ,18 September 2023
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News Article
Mackey: regulation of NHS managers ‘is coming’
Patient Safety Learning posted a news article in News
A national NHS leader has said regulation of managers ‘is coming’, and the service should ‘just go with it and make it as effective’ as possible. Sir Jim Mackey, national director for elective recovery and the chief executive of Northumbria Healthcare Foundation Trust, also told HSJ that regulation could offer better “protection” for management staff if implemented properly. NHS England is considering additional regulation of NHS management after being asked to “revisit” the idea by health and social care secretary Steve Barclay in the wake of the murder of babies by nurse Lucy Letby at the Countess of Chester Hospital. In an interview with HSJ, Sir Jim said: “Honestly, I think it’s coming. So we just need to go with it and make it as effective as it can be. It’s completely understandable in the current context for politicians and the public to want people in these positions to be regulated.” He continued: “There’s potentially some protection for people in being regulated in an effective way, as well as [being subject to] clear rules, clear processes. If somebody makes an allegation and it’s found to be wrong [and] you’ve been through a thorough regulatory process, it’s going to help you to move on and put it behind you.” Read full story (paywalled) Source: HSJ, 18 September 2023 -
News ArticleCertain spina bifida-related surgeries remain suspended at Children's Health Ireland at Temple Street (CHI) for almost a year amid serious allegations that unlicensed devices made with non-medical parts have been implanted in child patients. In two cases where these devices were used, the implants had to be removed from patients after causing significant harm, while the efficacy of a third is yet to be determined. One senior member at the hospital has raised concerns about the number of repeat operations required on young spina bifida patients and associated rates of reinfection, with disquiet in the hospital eventually leading to first an internal review of operations in October 2022 and later an external probe by US clinicians. In June this year there were 287 children on waiting lists in Ireland for life-changing spinal surgery. Despite a commitment first given by then health minister Simon Harris in 2017 that no child would be on the waiting list for more than four months, there are still more than 120 children waiting more than a year for scoliosis surgery, according to the Ombudsman for Children. CHI has declined to comment on allegations that one of its surgeons has used the unlicensed, failed implants, as well as its decision to cease operations on spina bifida patients. Patient advocate Amanda Santry, who took part in the external review on behalf of Spina Bifida & Hydrocephalus Paediatric Advocacy, has said she has been denied access to the review findings and has also called for a “full investigation” into the allegations of the use of non-medical parts. Read full story Source: The Ditch, 15 September 2023
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Content ArticlePhysician associates (PAs) work alongside doctors and form part of the multidisciplinary team. They work across a range of specialties in general practice, community and hospital settings. Anaesthesia associates (AAs), sometimes also known as physicians’ assistants (anaesthesia), work as part of the anaesthetic team. They provide care for patients before, during and after their operation or procedure. This General Medical Council (GMC) page outlines the roles of PAs and AAs and what the regulation will look like.
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Content Article
In a recent report, the Professional Standards Authority (PSA) for Health and Social Care sets out its view on the biggest challenges affecting the quality and safety of health and social care. In this blog, Alan Clamp, PSA's chief executive, summarises these challenges and the possible solutions. You can also read Patient Safety Learning's reflections on the PSA report here.- Posted
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Content ArticleThe Medical Protection Society (MPS) is a member-owned, not-for-profit protection organisation for doctors, dentists and healthcare professionals. Here is there response to the Department of Health and Social Care consultation which introduces the regulation for Physician Associates (PAs) and Anaesthesia Associates (AAs).
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Content Article
CQC: State of Care 2022/23
Patient Safety Learning posted an article in Care Quality Commission (CQC)
The Care Quality Commission (CQC) State of Care is an annual assessment of health care and social care in England. The report looks at the trends, shares examples of good and outstanding care, and highlights where care needs to improve. -
Content ArticleSafety Management Systems (SMSs) are an organised approach to managing safety which are widely used in different industries. In this report, the Health Services Safety Investigations Body (HSSIB) identifies the requirements for effective SMSs, how these are used in other safety-critical industries and considers the potential of application of this approach in healthcare. It makes safety recommendations for NHS England and the Care Quality Commission in relation to this. See also HSSIB's video Introduction to safety management systems.
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Content ArticleWhen a patient is deteriorating but no one is listening, Martha’s rule will guarantee a second opinion. Martha’s mother, Merope Mills, calls for doctors and nurses to embrace its implementation.
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Content ArticleThis is guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). These amendments currently apply in England, Scotland and Wales. This guidance should be regarded as good practice by pharmacists in Northern Ireland. The change comes into force in England, Scotland and Wales from 11 October 2023.
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Content ArticleIt is important that people who work in health and care are trained, skilled and treat patients and service users well. Regulators and accredited registers help to keep you safe by ‘registering’ health and care practitioners - you should check a practitioner’s registration when you: Pay for private services from a health or care practitioner. Employ a health or care practitioner. Commission services from a health or care practitioner. Have concerns about a practitioner. The link below allows you to search for a practitioner.
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Content ArticleThis report presents findings from a rapid evidence review into improvement cultures in health and adult social care settings. The review aims to inform CQC’s approach to assessing and encouraging improvement, improvement cultures and improvement capabilities of services, while maintaining and strengthening CQC’s regulatory role. It also identifies gaps in the current evidence base.
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EventuntilThis upcoming webinar from the Care Quality Commission will focus on quality statements and evidence categories. It will talk through where these two elements fit in the wider new regulatory approach and what guidance is available to help you understand them. The webinar will focus on example quality statements to explore how CQC will use evidence categories to identify specific sources of evidence to use in their assessments. Alongside the provider guidance, this webinar will give you the information you need to understand the evidence that CQC use to assess each of their new quality statements. This one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them and other stakeholders to hear the latest updates about CQC's new regulatory approach. The webinar will be led by Dave James, Head of Policy – Adult Social Care and Amanda Hutchinson, Head of Regulatory Change. Register
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News Article
Trust sent domestic abuse victim’s address to ex-partner, says regulator
Patient Safety Learning posted a news article in News
A trust has been reprimanded by the Information Commissioner’s Office (ICO) for exposing a domestic abuse victim to risk by disclosing their address to an ex-partner. University Hospitals Dorset Foundation Trust is one of only seven organisations in the UK – and the only NHS organisation – to have received a reprimand since July 2022 for a data breach involving a victim of domestic abuse. According to new details released by the ICO, University Hospitals Dorset received a reprimand in April this year over a procedure it had in place that, when sending correspondence by letter, would include the full addresses of all recipients of that letter without their consent to do so. In the case that was referred to the ICO, the subject of the data breach had their full address revealed to their ex-partner despite previous allegations of abuse, which has created a “risk of unwanted contact which will remain”. The ICO concluded that, while the subject did not request their address be withheld, it would not be a reasonable expectation that personal information would be shared without prior consent. The report raised concerns that UHD did not have a clear policy in place for managing situations where there are parental disputes and that no formal training was provided to administrative staff for dealing with such circumstances. Read full story (paywalled) Source: HSJ, 2 October 2023 -
Content ArticleInvestigative journalist and medical researcher Maryanne Demasi interviews Phillip Buckhaults, a cancer genomics expert and professor at the University of South Carolina. Professor Buckhaults describes how he decided to test for DNA contamination in vials of Pfizer and Moderna’s bivalent booster shots, hoping to debunk myths about contamination. However, his research revealed that billions of tiny DNA fragments are present in Pfizer’s mRNA vaccine. He highlights the need for further research to find out whether this poses any risk to people who have been given the vaccine, particularly around whether these fragments of DNA could trigger people developing cancer or autoimmune conditions.
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Content ArticleThese videos posted by Melissa Sheldrick tell the story of her son Andrew, who died aged eight from a medication error. The investigation into Andrew's death found that he had been given baclofen by his pharmacy instead of the tryptophan he had been prescribed. When tested, the dose of baclofen in the bottle given to Andrew contained three times the lethal dose of baclofen for adults. PSMF Melissa's story. In this video, Andrew's mother Melissa talks about what happened to Andrew and how it led to her campaigning for mandatory reporting of medication errors by pharmacists across Canada, Australia and the US. Patients taking the lead: Collaborating for safer healthcare. This presentation was originally given at the World Health Organization's (WHO's) World Patient Safety Day conference on 12 September 2023 in Geneva, Switzerland. Melissa tells Andrew's story and talks about how she has raised awareness of gaps in accountability for pharmacies and pharmacists. She describes how she was invited to be part of a taskforce to improve safety in pharmacy by the pharmacy regulator in her home state of Ontario—this was the first time a member of the public had been included in such a taskforce.
