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Showing results for tags 'Regulatory issue'.
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News ArticleExperts say robust legal protections are needed to inspire public confidence. The UK government has set out plans to amend drug regulations in case it decides that COVID-19 vaccines should be used before they are licensed, in a bid to roll them out more quickly. In a consultation on the proposals that ran from 28 August to 18 September the Department of Health and Social Care for England explained that if a suitable vaccine emerged with strong evidence of safety, quality, and efficacy the government would seek to license it through the usual route but could supply it in the meantime. The document added, “A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality, and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested.” The consultation, and the timeframe in which it was conducted, prompted some people to post their concerns on social media. However, the Human Medicine Regulations 2012 already allow the licensing authority to temporarily authorise the supply of an unlicensed product in response to certain public health threats, including the suspected spread of pathogens. The proposed change would allow conditions to be attached “to ensure product safety, quality, and efficacy” The 2012 regulations also give healthcare professionals and manufacturers immunity from being sued in the civil courts for the use of some unlicensed products recommended by the licensing authority in response to a public health threat. The new regulations would extend the immunity to drug companies that have not manufactured the product but placed it on the market with the approval of the licensing authority, and they clarify the consequences for a breach of conditions imposed by the authority. Social media posts play into existing concerns that many people might not accept the vaccine, as surveys indicate. Lawyers have told the Department for Health and Social Care that to inspire public confidence it must provide redress for the few people who might experience adverse effects. Bozena Michalowska, a partner specialising in product liability at the law firm Leigh Day, said, “I do not believe that people will want to play Russian roulette with their health by taking a vaccine which they know nothing about, especially when they know that the risks they take are just taken by them and not a shared risk and they will not have sufficient protection should things go wrong.” Read full story Source: The BMJ, 28 September 2020
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News Article
Regulator removes struggling hospital’s junior doctors
Patient Safety Learning posted a news article in News
Ten junior doctors have been removed from a struggling hospital over concerns they were being left without adequate supervision on understaffed wards. Health Education England (HEE) removed the 10 foundation year one doctors, all on a general medicine rota, from Weston General Hospital last month. The General Medical Council said the trust’s previous efforts to address the issues “have not been sufficient or sustainable”. University Hospitals Bristol and Weston Foundation Trust did not say which services HEE had removed the juniors from or what mitigations had been put in place. However, the trust told HSJ none of the positions concerned were from the hospital’s emergency department, where the GMC has already imposed conditions on juniors’ training. HEE very rarely uses its power to withdraw trusts’ trainees. HSJ reported last June the regulator had only removed two posts at trusts under enhanced monitoring since the start of 2019. William Oldfield, University Hospitals Bristol and Weston FT medical director, said in a statement to HSJ: “We recognise the seriousness of the step taken by HEE to temporarily suspend the training programme for a small number of junior doctors at Weston General Hospital. ”We are working to provide the assurance HEE require to allow this training to recommence, and in the meantime we have appropriately mitigated the impact on services at Weston.” Read full story (paywalled) Source: HSJ, 10 May 2021 -
News Article
NHSE sends improvement director into struggling acute trust
Patient Safety Learning posted a news article in News
Regulators have sent an improvement director into a North West acute trust amid multiple allegations of poor care and ‘cover up’ across different specialties. University Hospitals of Morecambe Bay Foundation Trust, which spent 18 months in special measures midway through the last decade, is again now the subject of significant regulatory intervention from NHS England. The regulator has appointed Simon Bennett as a board-level improvement director, which comes after he undertook a similar assignment at the struggling Stockport FT. It comes amid ongoing external investigations into the trust’s urology and trauma and orthopaedics specialties, where serious allegations have been made about attempts to cover up poor care. The trust has a troubled history of care failings and regulatory intervention, including a major maternity scandal which culminated in the Kirkup Inquiry in the first half of the 2010s, and being placed in special measures in 2014. It was widely recognised that positive progress was subsequently made to implement the inquiry recommendations and improve services, which culminated in the trust exiting special measures in late 2015, and being rated “good” by the CQC in early 2017. However, the recent allegations and investigations have again brought regulatory intervention. Read full story (paywalled) Source: HSJ, 20 April 2021 -
News ArticleA regulator has admitted “concerns” over the software Babylon Healthcare uses in one of its digital health solutions and is exploring how to address this. The Medicines and Healthcare products Regulatory Authority’s (MHRA) concerns relate to Babylon’s symptom checker “chatbot” tool. This is used by thousands of patients, including those registered with digital primary care practice GP at Hand. Two senior figures within the agency set out the MHRA’s concerns about the tool in a letter, seen by HSJ, which was sent to consultant oncologist David Watkins following a meeting between the parties last October. Dr Watkins has raised doubts over the tool’s safety for several years, including repeatedly documenting alleged flaws in the chatbot through videos posted online. However, last year, Babylon said only 20 of Dr Watkins’ 2,400 tests resulted in “genuine errors” being identified in the software. In the letter, dated 4 December, the MHRA’s clinical director for devices Duncan McPherson and head of software related device technologies Johan Ordish said Dr Watkins’ “concerns are all valid and ones that we share”. In the letter to Dr Watkins, the two MHRA directors also said the regulator is further exploring some of the issues highlighted and the work could “be important as we develop a new regulatory framework for medical devices in the UK”. Read full story (paywalled) Source: HSJ, 4 March 2021
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News Article
Modified vaccines for new Covid variants to be fast-tracked in UK
Patient Safety Learning posted a news article in News
The development of coronavirus vaccines tweaked to target new variants will be fast-tracked in the UK and four other countries, Britain’s regulator has said, adding that “robust evidence” on effectiveness and safety will still be required for authorisation. The approach, similar to the regulatory process for the modified flu vaccine, will not need a brand new approval or “lengthy” clinical studies, the Medicines and Healthcare Products Regulatory Agency (MHRA) said on Thursday. This will "significantly reduce" the length of time it takes for the vaccines to be ready, with concern mounting over the threat posed by the South African and Brazilian variants and their ability to partially evade the body’s immune response. Under the new guidance, developers will need to provide clear evidence their adapted vaccines produce a strong immune response to the variant and meet the high safety standards outlined by the MHRA. “This is based on scientific principles and does not cut any corners on safety or effectiveness,” said Dr Christian Schneider, chief scientific officer at the MHRA. Read full story Source: The Independent, 4 March 2021 -
News Article
Integrated care systems to be CQC-rated, says Hancock
Patient Safety Learning posted a news article in News
Health secretary Matt Hancock has said integrated care systems (ICS) will be rated by the Care Quality Commission (CQC). The government’s recent white paper for a new NHS bill did not discuss any change in the CQC’s legal framework to allow it to rate ICSs, which sparked uncertainty around how ICSs would be regulated. However, speaking in the House of Commons today of the “crucial” role the regulator plays in rating hospitals, Mr Hancock said: “I think that it is vital that the CQC has a similar role when it comes to ICSs.” The CQC has not confirmed what, if any, legal changes it is seeking. Currently, if the regulator wants to inspect how well a system is working, it must ask permission from the secretary of state to do so. It has carried out around 25 inspections of systems since 2017, but has not issued ratings. Giving evidence at a Parliamentary committee meeting earlier today, Sir Robert Francis, Healthwatch England chair, said: “A rating [from the CQC] that summarises the performance of the organisation to the public is a form of accountability. It doesn’t affect patient choice in quite the same way as a provider rating does, but it may be a way of explaining to the public how their system is doing.” He added that if inspectors are “continually being directed to go to the places the secretary of state chooses” then they may not carry the authority or credibility of an independent process. Read full story (paywalled) Source: HSJ, 2 March 2021 -
News ArticlePlans to give the health secretary control over a patient safety watchdog risks “massive untold consequences” for the NHS, experts have warned. Under proposals, Matt Hancock would be able to determine which incidents the Healthcare Safety Investigation Branch (HSIB) should investigate, while also being able to remove protections for NHS staff that mean they can give evidence without fear of reprisals. The move, outlined as part of wider reforms to the NHS, would give the health secretary far greater control over the HSIB than ministers currently have over the Air Accident Investigation Branch – on which the watchdog was modelled. Experts said the proposals cut across the original intention of an independent body that would act without fear or favour and earn the confidence of NHS staff. It is designed to operate under a so-called “safe space” for NHS staff to provide evidence of what went wrong during an incident without their testimony being used against them. Martin Bromiley, chair of the Clinical Human Factors Group and member of the expert panel that recommended the creation of HSIB in 2016, said he was seriously concerned over the plans. He said: “I am concerned about the reference to lifting safe space. As it stands with the Air Accident Investigation Branch people can apply to the High Court for it to be lifted and that makes sense because a judge can consider the whole case and the longer-term impact." Carl Macrae, Professor of Organisational Behaviour and Psychology at Nottingham University Business School, told The Independent: “I am very pleased to see there are concrete plans to establish HSIB as an independent body, but I am concerned this independence appears to be undermined by giving the secretary of state the power to tell it what to investigate." “People need to be able to trust that the healthcare investigator is acting with the sole purpose of improving safety and isn’t subject to political interference.” Read full story Source: The Independent, 24 February 2021
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News Article
Staff seeking second vaccination early threatened with ‘regulatory action’
Patient Safety Learning posted a news article in News
Staff at one of England’s largest hospital trusts have been threatened with disciplinary and regulatory action if they attempt to get their second COVID-19 vaccine dose early, HSJ has learned In an all staff email today, University Hospitals Birmingham Foundation Trust said: “Any staff trying to obtain a second dose ahead of their booked sessions could be considered deliberately attempting to deceive the NHS in order to obtain medicines and, as such will be a professional conduct issue which may result in disciplinary action and/or regulatory action being taken against you. The new note indicates the FT may have had a particular problem with staff seeking and/or getting second doses. The email said that if they attended vaccination centres, staff would be refused a second dose, and be asked to leave. Staff were also asked not to try and book another appointment at a different vaccination centre or “re-enter” the system through over means. The email added: “The current supply of vaccines is allocated to us to ensure all priority groups can receive their first dose and provide protection to as many as possible.” In December the trust’s executives were heavily criticised by unions for getting their first vaccine doses, after patients didn’t show up for appointments. The trust, which has been dealing with very large numbers of covid patients especially in intensive care, has also been the subject of concerns over culture and management in recent months. Read full story (paywalled) Source: HSJ, 20 February 2021 -
News ArticleStaff at a Midlands hospital trust told regulators they had repeatedly raised safety concerns internally without action being taken. The Care Quality Commission (CQC) has downgraded maternity services at Worcestershire Acute Hospital from “good” to “requires improvement” following an inspection prompted by the whistleblowers’ concerns. Staff had reported “continuously escalating” staffing level concerns to senior managers, but said they got “no response”. Some said they were fearful of raising concerns internally. Whistleblowers also reported delays to induction of labour, with examples of women waiting up to a week to be induced instead of one to two days. Managers said women who suffered delays were risk assessed. The CQC also identified a risk women might not be informed of significant harm caused to them or their babies following an incident, due to the way the trust was grading some babies who were admitted to the neonatal unit. However, it added: “When things went wrong, staff apologised and gave patients honest information and suitable support.” The report added the trust’s leaders were aware of the challenges in maternity, but “timely” action was not always taken to address the concerns. Read full story (paywalled) Source: HSJ, 19 February 2021
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News Article
Trusts could get new CQC ratings without inspection
Patient Safety Learning posted a news article in News
The Care Quality Commission (CQC) could regularly change its ratings of health and care providers without inspectors visiting them, under new plans from the watchdog. The CQC has said it wants to “move away from using comprehensive, on-site inspection as the main way of updating ratings” and instead use other sources like data and feedback from the public, to update ratings more regularly. At present — under the tough ratings regime introduced in 2014 in the wake of the Mid Staffs inquiry findings — it cannot change a provider’s score without carrying out a full inspection. It said in a recently published consultation that inspections “will remain an important part of how we assess quality,” but this will mostly be through more “targeted” inspections linked to significant risks to people’s safety, and the rights of vulnerable people. During the covid pandemic, CQC has targeted its on-site inspections at services where potential risks are identified, or where improvements are needed. Professor Ted Baker, the CQC’s chief inspector of hospitals, told HSJ the regulator wanted to move away from its current “fairly rigid” timetable of inspections in favour of a more “flexible” approach. Read full story (paywalled) Source: HSJ, 2 February 2021 -
News Article
GPs to fall under remit of new patient safety watchdog from 2023
Clive Flashman posted a news article in News
GP practices will be included in the remit of a new patient safety watchdog, due to come in from 2023 under the new Health and Care Bill, the Department of Health and Social Care (DHSC) has said. DHSC said that it expects the new Health Services Safety Investigations Body (HSSIB) to be ‘fully operational’ in England from April 2023 – ‘subject to parliamentary clearances’. It confirmed that the statutory independent body will investigate NHS care in GP practices, although it said that the HSSIB’s ‘focus is likely to be predominantly on investigating patient safety incidents in NHS trusts’. The body will also investigate care provided by the independent healthcare sector. RCGP vice-chair Dr Gary Howsam said: ‘It is important that we have further details about how this regulator will interact with general practice, and the expectations it will have of GPs and our teams, including ensuring GPs are not implicated for systemic issues out of their control.’ Read the full article here -
News Article‘Very heavy-handed, laborious and expensive’ inspections ‘have not been the right way’ of regulating hospitals, according to the Care Quality Commission’s (CQC) former chair. Speaking at a Royal Society of Medicine event on Wednesday, Lord David Prior, who is now the chair of NHS England, said “very few” physicians will have improved their work after reading a report from the regulator. He added that there is a role for the CQC to move in when “things are going wrong” although he is “sceptical” the regulator can actually drive improvement in hospitals. Lord Prior said: “I am highly sceptical as to whether or not CQC or any regulator can really drive improvement and drive the top hospitals to make them better. “And certainly I think there’ll be very few physicians who will say that their clinical work has improved as a result of reading a CQC report. “I think the sadness I have about CQC is that we have not been able, or it has not been able, to develop a series of predictive metrics that could replace these very heavy handed, very laborious and very expensive visits that we used to do.” Read full story (paywalled) Source: HSJ, 9 September 2021
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News Article
Unpublished hospital patient safety reports exposed
Patient Safety Learning posted a news article in News
Serious patient safety issues are being buried in confidential hospital reports, BBC Panorama has found. Freedom of Information requests revealed 111 reports, written by medical royal colleges, which NHS trusts have a duty to share. Eighty reports were given to the BBC but only 26 had been shared in full with regulators, and 16 published. The Department of Health would not comment on whether it might change the law to ensure publication. Since the 2015 Morecambe Bay maternity scandal in which 11 babies and a mother died, NHS Trusts are supposed to publish summaries of external reviews, and share them with the regulator. An earlier review into the hospital had previously identified concerns but had not been made public. Dr Bill Kirkup, who led a 2015 investigation into the Morecambe Bay scandal, said Panorama's findings were a "great disappointment". "People should know that there is something that is important enough to be looked at and they should know what the results of that scrutiny are. I can't understand what the rationale would be for withholding the existence of a report or the findings of the report. These are important matters of accountability in the public service." Read full story Source: BBC News, 19 May 2021 -
Event
The future for medicine regulation
Patient Safety Learning posted an event in Community Calendar
untilThis Westminster conference will examine key issues for medicine regulation, looking at next steps for clinical trials and patient involvement. Overall, key areas for discussion include: regulation - the MHRA’s Delivery Plan for 2021-23 - the evolving role and scope of the regulator - developing new approaches to regulation - partnerships. clinical trials - priorities for change following consultation - public involvement - efficiency - transparency - issues for ensuring patients are listened to and responded to as part of the process. innovation - regulatory support - developing frameworks to facilitate safe access to innovative products & new therapies - options for streamlining & fast-track approvals. wider priorities - evidence collection - improving health outcomes - engagement with the wider life sciences ecosystem - the UK’s international role. Keynote sessions with Dr Glenn Wells, Chief Partnerships Officer, MHRA; Juliet Tizzard, Director of Policy and Partnerships, Health Research Authority; Dr Ali Hansford, Head of Regulatory Strategy Policy, ABPI; and Meindert Boysen, Director, Centre of Health Technology Evaluation, NICE. The conference will be an opportunity for stakeholders to consider the issues alongside key policy officials who are due to attend from the DHSC; DIT; MHRA; GLD; OLS; and The Scottish Government. Register -
EventThis Westminster Health conference will discuss the next steps for professional healthcare regulation in the UK. It is being structured as an opportunity to consider: issues emerging from the Government’s consultations on regulating healthcare professionals measures in the Health and Social Care Act aimed at simplifying and modernising the legal framework for the regulation of health and care professions the impact of the pandemic on the landscape for professional healthcare regulation. Overall, areas for discussion include: priorities - changes in the approach to regulation ◦ placing patient safety at the heart of any new regulatory model. reform - stakeholder perspectives on proposals ◦ development of overarching criteria for regulation ◦ improving regulatory efficiency. impact - supporting regulated professionals to deliver high quality care ◦ preparing the workforce for the challenges of the future ◦ the role of regulatory reforms. safety - aligning reform with patient safety policy ◦ developing the role of regulation in promoting safe practices. education & training - next steps for providers ◦ quality assurance ◦ improving professionalism, leadership & delivery of new healthcare models. streamlining regulators - options & impact ◦ ensuring that there is capacity for any proposed changes to be effectively delivered. fitness to practise - assessing the future ◦ implications and priorities for health & wellbeing. the pandemic - how it has affected the landscape for healthcare regulation ◦ how to safeguard positive regulatory developments in upcoming reforms. Keynote contributions from Charlie Massey, Chief Executive and Registrar, General Medical Council; and Alan Clamp, Chief Executive, Professional Standards Authority. Patient Safety Learning's Helen Hughes will be one of the speakers. Register
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EventuntilThe Medicines and Healthcare products Regulatory Agency (MHRA) will be holding a joint virtual Innovative Licencing and Access Pathway (ILAP) information and update session. This event will provide an opportunity for patient groups and patient experts to receive an update on the work of the ILAP, how the MHRA involve patient and public representatives, and future developments about how the MHRA are accelerating the time to market and facilitating patient access to innovative medicines. This event is open to all patient and public representatives who are involved in the work of any of the ILAP partners. Along with presentations from some of the ILAP team, a patient representative will share their experiences as a member of the pilot ILAP Patient and Public Reference Group. There will also be a panel discussion session with plenty of opportunity for questions from participants. Register
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EventThis Westminster Forum conference will be an important opportunity to examine the next steps for improving patient safety in the NHS in the context of the ongoing pandemic, the updated Patient Safety Strategy, and the MHRA consultation launched to improve patient safety and regulation around medical devices. Delegates will also discuss priorities in the context of the Health and Care Bill, which includes measures aiming to strengthen the role of the Healthcare Safety Investigation Branch (HSIB) in improving patient safety. Key areas for discussion include: system learning - assessing approaches, sharing best practice, supporting the workforce, education and training, and building a learning culture patient involvement - examining priorities for involving patients and the public within patient safety regulation - options for a more flexible and adaptable approach clinical negligence - how best to improve the negligence system the role of the HSIB - including its scope going forward and informing whole system learning COVID-19 - looking at what has been learned for patient safety and how best to drive improvements in recovery from the pandemic and into the future. Register
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EventuntilWhile the pandemic didn’t cause all the shifts happening in healthcare, it had a major hand in accelerating and shaping the changes that will alter the healthcare landscape far into the future. Join Fierce Healthcare as we examine the tectonic transformation across healthcare. We’ll explore changing consumer expectations in access to care, the moves by major tech players and providers to reach their customers and strategies for actually paying for everything. Register
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EventHere is how to obtain a quick overview of the new Acceptable Means of Compliance (AMC) and Guidance Material (GM) addressing software published in October 2019 (Reference: ED Decision 2019/022/R). Note: Participation to Basics of regulation on the 02/03/2021 is recommended if you don't know what are AMC, GM and structure of 2017/373. Register
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EventuntilThis Westminster Health Forum policy conference will examine next steps for maternity services in England. Areas for discussion include: the Ockenden Review and the NHS Long Term Plan - progress and outstanding issues in meeting recommendations and ambitions relating to maternity care care during COVID-19 - adjustments in delivery, lessons learned, and possible directions for post-pandemic maternal care and recovery of services health inequalities - looking at priorities for how they can be address and improving support key issues for innovation, safety and regulation. Agenda Register
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Event
Veracuity: Innovative approaches to drug safety
Sam posted an event in Community Calendar
Veracuity was conceived out of a recognition that the practice of pharmacovigilance is performed suboptimally. That is because it relies entirely on a voluntary reporting system – one in which consumers and healthcare professionals must devote considerable energy if they were so inclined to notify somebody about a side effect they attribute to a bio-pharmaceutical product. Adverse event reporting is infrequent and cumbersome because stakeholders are only vaguely aware of their responsibility and the current system is neither easy nor fast to use. Nor does it provide reporters with any immediate helpful feedback. With only a very small percentage of adverse drug events ever reaching the attention of manufacturers or regulators, it is easy to conclude that the medical community and the public may be wholly unaware of tremendous risks and liabilities that may be attributed to drug products. This workshop allows participation in insightful conversation on the future of our industry. Program: Fishbein, J: Introduction and closing remarks. Barrett, CP: Implementation of Post-marketing Risk Management Commitment. Laugel, I: The future of pharmacovigilance with the use of artificial intelligence sounds good. Marschler, M: The use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products. This webinar meets two times. Fri, Jan 29, 2021 12:00 PM - 2:00 PM GMT Fri, Jan 29, 2021 6:00 PM - 8:00 PM GMT Register 2021-workshop-flier.pdf -
Content ArticleThis open letter from the Pharmacists' Defence Association (PDA) raises concerns about unnecessary full or part-day closures of community pharmacies throughout the UK by some large multiple pharmacy operators. The letter states that these operators are telling patients and the government that they have been unable to find pharmacists, citing an alleged national pharmacist shortage. However, the PDA's members report that this is not the case, and the letter draws attention to closures being planned four weeks in advance, and to locum pharmacists having agreed rates of pay reduced at the last minute. The PDA highlights the risk to patient safety caused by these closures, and calls for more regulatory action to be taken by the government and other regulators. The letter is addressed to: Government Health Secretaries of England, Northern Ireland, Scotland and Wales Chief Executives of the National Health Service in England, Northern Ireland, Scotland and Wales NHS Chief Pharmaceutical Officers for England, Northern Ireland, Scotland and Wales Chief Executive of General Pharmaceutical Council and Pharmaceutical Society of Northern Ireland.
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Content ArticleThis study presents the findings of ‘The concept of seriousness in fitness to practise’ project commissioned by the General Dental Council (GDC) and the Nursing and Midwifery Council (NMC). The project took place between December 2019 and September 2021 and investigated how seriousness in Fitness to Practise (FtP) cases is understood and applied by health professions regulators. The research aimed to: develop an understanding of how the concept of seriousness in relation to misconduct is defined and applied by professional regulators, and to identify the considerations that influence that application. achieve a clearer understanding of the similarities and differences in approaches across regulation and reasons for these. describe the relationship between professional misconduct, enforcement actions and the statutory objectives of healthcare regulation.
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Content ArticleDiscussion on issues relating to vaginal mesh implants from 29 Jun 2022.
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Content ArticleContinuing the 'Why investigate' series, in this blog, Martin Langham looks at collecting data, introduces the idea of measurement, and asks what published science is there for testing it ‘beyond reasonable doubt’.
