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Showing results for tags 'Regulatory issue'.
Found 469 results
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News ArticleMore than two-thirds of people who are administering cosmetic surgery injections such as Botox in the UK are not qualified medical doctors, a new study suggests. The study is the first survey of who is providing cosmetic injectable services, including botulinum toxin (Botox) and dermal fillers, in the country. Dr David Zargaran, UCL Plastic Surgery, an author of the study, said: “There are well-documented, yet to-date unaddressed challenges in the UK cosmetic injectables market. “Without knowledge of the professional backgrounds of practitioners, we cannot adequately regulate the industry. “Our research highlights that the majority of practitioners are not doctors and include other healthcare professionals, as well as non-healthcare professionals such as beauticians. “The range of backgrounds opens a broader question relating to competence and consent. Read full story Source: The Independent, 24 July 2023
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EventuntilThis upcoming webinar will focus on CQCs approach for rolling out the new regulatory approach and provider portal to all health and social care providers. 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 our new regulatory approach. The webinar will be led by Chris Day, our Director of Engagement and Amanda Hutchinson, our Head of Regulatory Change. Register
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News ArticleThe majority of trust leaders have reported an increase in the ‘burden’ put on them by regulators, citing more demanding ‘ad hoc’ requests during heightened operational pressure. In NHS Providers’ latest survey of NHS trust leaders’ experiences of regulation, a little over half of respondents – 52% – said the burden from NHS England and the Care Quality Commission had increased in the past year. The percentage was higher among acute/community and community trusts, and all ambulance and specialist trust respondents said the burden had increased. An even higher overall share of trusts – 59% – said “ad hoc requests” from regulators had increased during the same time period. This includes requests for information or meetings at short notice, diverting staff from day-to-day operational duties. Read full story (paywalled) Source: HSJ, 20 July 2023
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Content ArticleInvestigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up. This article in Nature looks at the findings of researchers who have been studying clinical trials and calling for greater regulatory scrutiny. It particularly examines the work of John Carlisle, NHS anaesthetist and editor at the journal Anaesthesia, who scrutinised over 500 studies with randomised controlled trials, over a period of three years. Carlisle found that 26% of the papers had problems that were so widespread that the trial was impossible to trust, either because the authors were incompetent or because they had faked the data. He called these ‘zombie’ trials because they had the semblance of real research, but closer scrutiny showed they were masquerading as reliable information.
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News Article
US regulators approve first over-the-counter contraceptive pill
Patient Safety Learning posted a news article in News
The US Food and Drug Administration (FDA) has approved the first over-the-counter contraceptive pill, allowing millions of women and girls in the country to buy contraception without a prescription at a time when some states have sought to restrict access to birth control and abortion. FDA officials said on Thursday it cleared Perrigo’s Opill – an every day, prescription-only hormonal contraception first approved in 1973 – to be sold over-the-counter. The pill will be available in stores and online in the first quarter of next year, and there will be no age restrictions on sales. The regulatory approval paves the way for people to purchase the pill without a prescription for the first time since oral contraceptives became widely available in the 1960s. “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, the director of the FDA’s center for drug evaluation and research, said in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.” Read full story Source: The Guardian, 13 July 2023 -
News Article
CQC inspection process may be ‘disproportionate’, finds Government review
Patient Safety Learning posted a news article in News
The Care Quality Commission (CQC) inspection process may be ‘disproportionate’, a Government survey found, although the incredibly low response rate hampered conclusions. All 51,000 providers registered with the CQC were given access to a survey as part of a post implementation review but only 86 responded and only 36 of those were NHS providers. Most NHS responses to the survey came from organisations employing between 10 and 49 people, the review found. The lack of engagement with the survey meant no conclusion could be reached about whether an alternative system would impose less regulation of the health and social care sector. Criticisms among those who did respond included that the registration process is too inflexible, and the regulations too onerous and burdensome. Some also felt the CQC regulations do not cover all health and social care activities where there is a possible risk to patient safety or service users. Read full story Source: Pulse, 13 July 2023 -
Content ArticleThe author of this blog published by Sling the Mesh, writes that ever year new healthcare treatments are launched underpinned by flawed, mischievous, flimsy and fraudulent scientific evidence – also known as cheating. They look at different types of cheating and argue that cheating helped push surgical mesh implants as ‘gold standard’.
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Content ArticleThe Safe Care at Home Review is an important reminder that people with care and support needs may experience abuse and neglect, sometimes under the guise of ‘care’. Older people, or people with disabilities, may be particularly vulnerable to harm because of their dependence on others and the complexity of their care needs. They might rely on other people for physical, mental or financial support, and may face difficulties recognising or reporting harm. The review draws on a range of evidence, including the Home Office funded Vulnerability Knowledge and Practice Programme, which has highlighted that one in six domestic homicides involved people who were cared for by, or caring for, the suspect.
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Content Article
Mental Capacity and Mental Health Legislation
Patient_Safety_Learning posted an article in Consent and privacy
This guide, published by Patient, outlines some of the key elements of mental capacity and mental health legislation including: General principles of consent Emergency treatment Best interests Adults who are not competent to give consent Advance care planning Mental Health Act relevant to consent Section 57: Treatment requiring consent and a second opinion. -
News ArticlePharmaceutical giants are pouring tens of millions of pounds into struggling NHS services – including paying the salaries of medical staff and funding the redesign of patient treatment – as they seek to boost drug sales in the UK, the Observer can reveal. The spending is revealed in an investigation that lays bare the growing role of Big Pharma in the UK’s health sector, with analysis of more than 300,000 drug company transactions since 2015 showing a surge in spending on activities other than research and development (R&D). Payments to UK health professionals and organisations, including donations, sponsorship, consultancy fees and expenses, reached a record £200m in 2022, excluding R&D with companies seeking to promote lucrative drugs for obesity, diabetes and heart conditions among the biggest spenders. The rise in spending raises concerns about the growing influence of pharmaceutical companies in the NHS as it reaches its 75th anniversary milestone. Amid record pressure on services, drug giants say closer collaboration can help deliver major benefits to patients. NHS England said collaborations with industry helped patients “benefit from faster access to innovative treatments” and that it was “not unusual for industry to provide funding to support service delivery in areas such as improving cardiovascular health, tackling infectious disease or rolling out innovative cancer therapies”. It added that “strict safeguards” were in place for managing conflicts of interest. Read full story Source: The Guardian, 8 July 2023
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Content ArticleThis factsheet from the General Medical Council sets out some of the key legislation and case law relating to medical decision making and consent in the UK. It is not intended to be a comprehensive list, nor is it a substitute for independent, up-to-date legal advice.
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News Article
Weight-loss jabs investigated for suicide risk
Patient Safety Learning posted a news article in News
Europe's drugs regulator has told BBC News it is conducting a review of some weight-loss jabs after being alerted to a possible link to thoughts of suicide and self-harm among users. Member state Iceland notified the European Medicines Agency after seeing three cases. The safety assessment will look at Wegovy, Saxenda and similar drugs, such as Ozempic, that help curb appetite. Product leaflets already list suicidal thoughts as a possible side effect. An EMA official said: "The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency, following three case reports. "A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. "The case reports included two cases of suicidal thoughts - one following the use of Saxenda and one after Ozempic. "One additional case reported thoughts of self-injury with Saxenda. "The EMA will communicate further when more information becomes available." Read full story Source: BBC News, 10 July 2023 -
Content Article
“I’ve been mocked, scolded and gaslighted”: a harmed patient’s experience of orthodontic treatment
Anonymous posted an article in Other conditions and diseases
In this opinion piece, a patient shares their experience of trying to access support from the healthcare system for debilitating jaw pain. They describe being dismissed and laughed at by doctors and orthodontists, highlight a knowledge gap around jaw issues and outline the need for more accountability in the orthodontics industry. -
Content ArticleThis easy-read guidance outlines what the Care Quality Commission (CQC) expects good care to look like for autistic people and people with a learning disability. It explains how the CQC aims to help health and adult social care services develop and run services that are right for the people they serve.
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Content ArticleThe Professional Standards Authority (PSA) oversees the work of 10 statutory bodies that regulate health and social care professionals in the UK. In undertaking this oversight role, PSA strive to strike a proper balance between scrutiny on the one hand, and advice and support on the other. During 2022/23 they implemented changes to their performance review processes to ensure they continue to be proportionate and that they contribute to improvements in professional regulation. This year PSA have made further improvements to their performance reviews for the statutory regulators in health and social care and to their Accredited Registers programme. They published their Safer care for all report in September 2022.
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News Article
Patient dies and three hospitalised in Sciensus chemotherapy incident
Patient Safety Learning posted a news article in News
A cancer patient has died and three others have been hospitalised after they were administered unlicensed versions of chemotherapy by Sciensus, a private company paid millions by the NHS to provide essential medication. Three health regulators have launched inquiries into the incident, according to people familiar with the matter. It was caused by an issue at the firm’s medicines manufacturing unit. In a statement, Sciensus confirmed an “isolated incident” had “affected four patients” and that it was “deeply saddened” that one of them had died. Sciensus offered its “sincere condolences” to the family and friends of the patient who died, and is conducting a thorough investigation, it added. The four patients received unlicensed versions of cabazitaxel, a licensed chemotherapy used to treat prostate cancer. The versions administered to the patients differed from the licensed product and therefore were considered unlicensed medicines. Sciensus is required to comply with official standards to ensure the quality of the products it produces and the protection of public health. Breaches of these standards can result in the MHRA suspending or removing a company’s licence. “Patient safety is our highest priority,” said Dr Alison Cave, the MHRA’s chief safety officer. “We are urgently investigating this issue and we will take any necessary regulatory measures to ensure patients are protected." Read full story Source: The Guardian, 7 July 2023 -
News Article
Sarms: Illegal muscle drugs sold in UK shops, BBC finds
Patient Safety Learning posted a news article in News
"Dangerous" muscle-building drugs are being sold illegally in shops around the UK, a BBC investigation has found. The substances, known as Sarms, can cause erectile dysfunction, mood swings and liver problems, doctors warn. Secret filming by the BBC found they were widely available in shops that sell bodybuilding supplements as well as online. Responding to the findings, the Royal Pharmaceutical Society (RPS) called for the law to be tightened. Sarms - which stands for selective androgen receptor modulators - are body-enhancing drugs that mimic the effects of anabolic steroids, which increase muscle mass and strength. Originally developed as an experimental drug to treat muscle-wasting conditions, they have become popular with gym-goers on social media who want to build muscle and lose fat. Read full story Source: BBC News, 7 July 2023 -
Content ArticleFollowing an extensive process of internal and external engagement, the Medicines and Healthcare products Regulatory Agency has published their corporate plan for the next 3 years. Their priorities are: Maintain public trust through transparency and proactive communication Enable healthcare access to safe and effective medical products Deliver scientific and regulatory excellence through strategic partnerships Become an agency where people flourish alongside a responsive customer service culture.
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Content ArticleIn this blog, Kath Sansom, founder of campaign group Sling the Mesh, outlines her concerns about three new mesh products for muscle and tendon injuries that have been given near automatic approval by the US Food and Drug Administration (FDA). She highlights that although the manufacturers claim the products have caused no sensitivity issues and no adverse responses in animals, there is no data on the potential long term impact of the mesh devices. Highlighting the knowledge that we now have about the potential for surgical mesh to cause severe injury and side-effects, Kath raises concerns about the lack of regulatory rigour and the potential for these degradable devices to cause fibromyalgia and other systemic issues. Read more about the approval of products for shoulder soft tissue repair
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News ArticleHealthcare staff from the European Union can join or continue to work in the NHS for the next five years without undergoing additional exams or further assessments, the government has decided. The “standstill provisions”, which were put in place after the UK left the European Union in 2020, have been extended by government until 2028. The NHS has become increasingly reliant on recruiting staff from overseas, particularly nurses, but has seen a significant drop in the number of staff joining from the European Union post-Brexit. The review by the Department of Health and Social Care said: “Retaining the standstill provisions for a temporary period of five years will support the [DHSC’s] ambition to attract and recruit overseas healthcare professionals, without introducing complex and burdensome registration routes. “[European Economic Area]-qualified healthcare professionals will be able to continue to register with the relevant professional regulator, without the need to sit additional professional exams, mitigating delays to registration and employment in the NHS.” Read full story (paywalled) Source: HSJ, 29 June 2023
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News Article
Legal right to visit patients proposed by government
Patient Safety Learning posted a news article in News
The government has proposed new legislation to make patient visiting a legal right and also give the Care Quality Commission (CQC) fresh powers to enforce it. The Department of Health and Social Care has launched a consultation to seek views from patients, care home residents, families, professionals and providers on the introduction of new legislation which will require health and care settings, including hospitals, to accommodate visitors in most circumstances. It said the new visiting laws will also provide the CQC with a “clearer basis for identifying where hospitals and care homes are not meeting the required standard”, and enable it to enforce the standards by issuing requirement or warning notices, imposing conditions, suspending a registration or cancelling a registration. It said although the CQC currently has powers “to clamp down on unethical visiting restrictions”, the expected standard of visiting rules is not “specifically outlined in regulations”. Read full story (paywalled) Source: HSJ, 21 June 2023 -
News Article
Fresh review into ‘doctors being bullied with regulatory referrals’
Patient Safety Learning posted a news article in News
Investigators have begun a further review of how a major trust handles disciplinary and professional standards cases, including allegations leaders had targeted some doctors with referrals to the medical regulator, HSJ has learned. The claims were part of a raft of concerns raised about University Hospitals Birmingham Foundation Trust over recent months, including BBC Newsnight reporting that a large number of General Medical Council referrals had led to no action; and claims of whistleblowing doctors “being bullied… by the threat of referrals to the GMC”. One external review of UHB, whose report was published in March, already examined the issue, and said it had identified 17 cases which contradicted Newsnight’s claim, with two referrals resulting in criminal conviction and removal from the medical register. It said there was “nothing exceptional” about the referral numbers or types at UHB, or their outcomes, but also noted that medical staff told the review about “dysfunctional processes for maintaining higher professional standards”, and “expressed a perception that there was a rather rapid process to escalate to a GMC referral”. Read full story (paywalled) Source: HSJ, 21 June 2023 -
Event
Ethics and regulation for AI in health
Patient Safety Learning posted an event in Community Calendar
untilAs the adoption of artificial intelligence (AI) in health and care continues to progress rapidly, it's essential that clinicians ensure this technology is used for the benefit of patients and to assist us in providing equitable and high-quality care both now and in the future. However, it's also crucial that we are aware of the potential risks and unintended consequences of using AI. This month, the RSM will delve into the development of machine learning (ML) and AI and their applications to healthcare. It will also debate the need for ethical guidelines and regulation in this field. By attending this event, you will understand: What is machine learning and artificial intelligence. How AI is being currently applied to healthcare and the potential future uses. How data drives AI and the potential bias within the data. The way ML and AI can lead to errors and harm. The ethical issues surrounding the use of AI in healthcare. The need for regulations and governance, both in healthcare and the broader society. Register -
News ArticleThe government should ‘relieve’ GP practices of being the sole controller for their patients’ data, a senior NHS England director has said. Tim Ferris, NHSE director of transformation, said it was a “challenge” that GP practices acted as the sole controllers of their patients’ data. Dr Ferris, whose background is as a primary care doctor in the US, was giving evidence to a Lords committee on integration of primary and community care today. He was asked whether it was time to revisit legislation on the control of GP patient data. He said: “Thirty years ago when the law was created, it made more sense. But I think it might no longer be fit for purpose… The idea that if I were a GP in this country, if I had legal liability for the exchange of data, I would be worried about that.” Dr Ferris agreed there would be merit to the committee recommending the government “relieve” GPs of the sole responsibility for data protection, and their data controller status. Read full story (paywalled) Source: HSJ, 20 June 2023
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Content ArticleThe 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. The terms of reference were: “To conduct a review of how the General Medical Council handles cases involving individuals who regard themselves as whistleblowers and who have appropriately raised concerns in the public interest. These are individuals: whose fitness to practise is being investigated or determined under the General Medical Council (Fitness to Practise) Rules 2004; or who have reported such a concern to the GMC.” This is the report by the Right Honourable Sir Anthony Hooper to the GMC presented on the 19th March 2015.
