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Found 473 results
  1. News Article
    In September last year, Ebrima Sajnia watched helplessly as his young son slowly died in front of his eyes. Mr Sajnia says three-year-old Lamin was set to start attending nursery school in a few weeks when he got a fever. A doctor at a local clinic prescribed medicines, including a cough syrup. Over the next few days, Lamin's condition deteriorated as he struggled to eat and even urinate. He was admitted to a hospital, where doctors detected kidney issues. Within seven days, Lamin was dead. He was among around 70 children - younger than five - who died in The Gambia of acute kidney injuries between July and October last year after consuming one of four cough syrups made by an Indian company called Maiden Pharmaceuticals. In October, the World Health Organization (WHO) linked the deaths to the syrups, saying it had found "unacceptable" levels of toxins in the medicines. A Gambian parliamentary panel also concluded after investigations that the deaths were the result of the children ingesting the syrups. Both Maiden Pharmaceuticals and the Indian government have denied this - India said in December that the syrups complied with quality standards when tested domestically. It's an assessment that Amadou Camara, chairperson of the Gambian panel that investigated the deaths, strongly disagrees with. "We have evidence. We tested these drugs. [They] contained unacceptable amounts of ethylene glycol and diethylene glycol, and these were directly imported from India, manufactured by Maiden," he says. Ethylene glycol and diethylene glycol are toxic to humans and could be fatal if consumed". Read full story Source: BBC News, 21 August 2023
  2. News Article
    The Care Quality Commission (CQC) has published a report on Stoke Mandeville Hospital, part of Buckinghamshire Healthcare NHS Trust following a recent inspection in June. CQC carried out a focused inspection of the trusts children’s emergency department in response to concerns raised about the safety and quality of the service. Inspectors found children and young people received safe care. However, the trust needs to review its systems to make sure potential serious incidents are managed in a way that allows any lessons learned to be shared, to reduce the risk of them happening again. Link to the full report (opens in a new browser window)
  3. News Article
    Drug companies are systematically funding grassroots patient groups that lobby the NHS medicines watchdog to approve the rollout of their drugs, the Observer has revealed. An investigation by the Observer has found that of 173 drug appraisals conducted by the National Institute for Health and Care Excellence (NICE) since April 2021, 138 involved patient groups that had a financial link to the maker of the drug being assessed, or have since received funding. Often, the financial interests were not clearly disclosed in NICE transparency documents. Many of the groups that received the payments went on to make impassioned pleas to England’s medicines watchdog calling for treatments to be approved for diseases and illnesses including cancer, heart disease, migraine and diabetes. Others made submissions appealing NICE decisions when medicines were refused for being too expensive. In one case, a small heart failure charity that gave evidence to a NICE committee arguing for a drug to be approved received £200,000 from the pharmaceutical company, according to the maker’s spending records. In another case, a cancer patient group supplied evidence relating to drugs made by 10 companies – from nine of which it had received funding. Read full story Source: The Guardian, 22 July 2023
  4. News Article
    Britain’s health regulator has partly suspended the manufacturing licence of Sciensus, a private company paid millions by the NHS to provide vital medicines, after the death of a cancer patient who was given the wrong dose of chemotherapy. The Medicines and Healthcare products Regulatory Agency (MHRA) said it had taken “immediate” action under regulation 28 of the Human Medicines Regulations 2012 law “where it appears to the MHRA that in the interests of safety the licence should be suspended”. The MHRA found “significant deficiencies” in standards at Sciensus during an investigation triggered by the death of one patient and the hospitalisation of three others. All four patients were administered “incorrect” doses of an unlicensed version of cabazitaxel, a licensed chemotherapy used to treat prostate cancer, according to people familiar with the matter. Read full story Source: The Guardian, 25 July 2023
  5. News Article
    More 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
  6. Event
    until
    This 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
  7. News Article
    The 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
  8. Content Article
    Investigations 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.
  9. News Article
    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
  10. News Article
    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
  11. Content Article
    The 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’.
  12. Content Article
    The 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.
  13. Content Article
    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.
  14. News Article
    Pharmaceutical 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
  15. Content Article
    This 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.
  16. News Article
    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
  17. Content Article
    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.
  18. Content Article
    This 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.
  19. Content Article
    The 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.
  20. News Article
    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
  21. News Article
    "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
  22. Content Article
    Following 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.
  23. Content Article
    In 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
  24. News Article
    Healthcare 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
  25. News Article
    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
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