Jump to content

Search the hub

Showing results for tags 'Regulatory issue'.

More search options

  • Search By Tags

    Start to type the tag you want to use, then select from the list.

  • Search By Author

Content Type


Forums

  • All
    • Commissioning, service provision and innovation in health and care
    • Coronavirus (COVID-19)
    • Culture
    • Improving patient safety
    • Investigations, risk management and legal issues
    • Leadership for patient safety
    • Organisations linked to patient safety (UK and beyond)
    • Patient engagement
    • Patient safety in health and care
    • Patient Safety Learning
    • Professionalising patient safety
    • Research, data and insight
    • Miscellaneous

Categories

  • Commissioning, service provision and innovation in health and care
    • Commissioning and funding patient safety
    • Digital health and care service provision
    • Health records and plans
    • Innovation programmes in health and care
    • Climate change/sustainability
  • Coronavirus (COVID-19)
    • Blogs
    • Data, research and statistics
    • Frontline insights during the pandemic
    • Good practice and useful resources
    • Guidance
    • Mental health
    • Exit strategies
    • Patient recovery
    • Questions around Government governance
  • Culture
    • Bullying and fear
    • Good practice
    • Occupational health and safety
    • Safety culture programmes
    • Second victim
    • Speak Up Guardians
    • Staff safety
    • Whistle blowing
  • Improving patient safety
    • Clinical governance and audits
    • Design for safety
    • Disasters averted/near misses
    • Equipment and facilities
    • Error traps
    • Health inequalities
    • Human factors (improving human performance in care delivery)
    • Improving systems of care
    • Implementation of improvements
    • International development and humanitarian
    • Safety stories
    • Stories from the front line
    • Workforce and resources
  • Investigations, risk management and legal issues
    • Investigations and complaints
    • Risk management and legal issues
  • Leadership for patient safety
    • Business case for patient safety
    • Boards
    • Clinical leadership
    • Exec teams
    • Inquiries
    • International reports
    • National/Governmental
    • Patient Safety Commissioner
    • Quality and safety reports
    • Techniques
    • Other
  • Organisations linked to patient safety (UK and beyond)
    • Government and ALB direction and guidance
    • International patient safety
    • Regulators and their regulations
  • Patient engagement
    • Consent and privacy
    • Harmed care patient pathways/post-incident pathways
    • How to engage for patient safety
    • Keeping patients safe
    • Patient-centred care
    • Patient Safety Partners
    • Patient stories
  • Patient safety in health and care
    • Care settings
    • Conditions
    • Diagnosis
    • High risk areas
    • Learning disabilities
    • Medication
    • Mental health
    • Men's health
    • Patient management
    • Social care
    • Transitions of care
    • Women's health
  • Patient Safety Learning
    • Patient Safety Learning campaigns
    • Patient Safety Learning documents
    • Patient Safety Standards
    • 2-minute Tuesdays
    • Patient Safety Learning Annual Conference 2019
    • Patient Safety Learning Annual Conference 2018
    • Patient Safety Learning Awards 2019
    • Patient Safety Learning Interviews
    • Patient Safety Learning webinars
  • Professionalising patient safety
    • Accreditation for patient safety
    • Competency framework
    • Medical students
    • Patient safety standards
    • Training & education
  • Research, data and insight
    • Data and insight
    • Research
  • Miscellaneous

News

  • News

Find results in...

Find results that contain...


Date Created

  • Start
    End

Last updated

  • Start
    End

Filter by number of...

Joined

  • Start

    End

Group

First name

Last name

Country

Join a private group (if appropriate)

About me

Organisation

Role

Found 469 results
  1. News Article
    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
  2. Content Article
    In 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.
  3. News Article
    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
  4. News Article
    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
  5. News Article
    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
  6. Content Article
    Physician 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.
  7. Content Article
    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.
  8. Content Article
    The 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).
  9. News Article
    Thousands 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
  10. Content Article
    Safety 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.
  11. Content Article
    When 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.
  12. News Article
    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
  13. News Article
    The 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
  14. 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.
  15. News Article
    Valproate-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
  16. Content Article
    This 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. 
  17. Content Article
    It 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.
  18. Content Article
    This 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.
  19. Event
    until
    This 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
  20. News Article
    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
  21. Content Article
    Investigative 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.
  22. Content Article
    These 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.
  23. News Article
    More than 1 in 10 sexual harassment complaints against doctors are not investigated by the General Medical Council because of an “arbitary” rule, the Observer has revealed. According to data obtained under the Freedom of Information Act, 13% of sexual misconduct complaints made between the years 2017-18 and 2021-22 were closed without investigation because the GMC is prevented from considering alleged incidents more than five years after the event. As part of the council’s remit to protect patient safety and improve medical education and practice across the UK it investigates any kind of complaint against doctors. The figures show the GMC refused to investigate 170 complaints relating to sexual assault, attempted rape, and rape in the period analysed. In 22 of those cases the five-year rule was cited. It received 566 sexual harassment complaints in the same period. Anthony Omo, the GMC’s general counsel and director of fitness to practise, told the Observer: “We can and do waive the five-year rule where there are grave allegations involving sexual assault or rape. In many cases involving sexual allegations, the GMC’s position will be that such serious misconduct is incompatible with continued registration.” A government consultation in February heard that the five-year-rule was “arbitrary” and “a barrier to public protection” as it allowed doctors who may be guilty of inappropriate behaviour to continue practising. However, despite commitments from the Department of Health and Social Care to scrap the limitation as a “top priority”, no date has been set. Read full story Source: The Guardian, 30 September 2023
  24. Content Article
    CQC's completed programme, which started in 2014, of comprehensive inspections of all specialist mental health services in England.
  25. Content Article
    In this article, Sharon Hartles highlights the high-profile legal battle involving numerous Primodos-affected claimants against pharmaceutical companies and the government. The court ruled against the claimants, dismissing their claims related to hormone pregnancy tests and foetal harm. This decision led to disappointment and criticism from advocates, MPs, and academics involved in the Primodos scandal. Sharon Hartles is affiliated with the Risky Hormones research project, which is an international collaboration in partnership with patient groups. Additionally, she is a member of the Harm and Evidence Research Collaborative at the Open University. Related reading on the hub: Primodos 2023: The fight for justice continues for the Association for Children Damaged by Hormone Pregnancy Tests Primodos, mesh and sodium valproate: Recommendations and the UK Government’s response Primodos: The next steps towards justice Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests
×
×
  • Create New...