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Content ArticleDespite global consensus that access to pharmaceuticals as a lifesaving commodity is a fundamental human right, 2 billion people globally still lack access to medicines. In this blog, Karrar Karrar, Access to Medicines Adviser at Save the Children, looks at why weak regulatory systems are a major patient safety issue in low- and middle-income countries. He highlights that lack of regulatory capacity results in falsified, substandard and fake medicines making their way into local pharmacies and hospitals. It also delays patient access to new medicines due to lengthy processing times. Karrar argues that governments must prioritise investments in strengthening national regulatory systems and increase cross-country collaboration to strengthen regional and global regulatory networks and systems.
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Last week the Professional Standards Authority for Health and Social Care (PSA) published a new report, Safer care for all – solutions from professional regulation and beyond, which examines the current state of professional health and care regulation in the UK. In this blog, Patient Safety Learning considers this report from a patient safety perspective. PSA's chief executive, Alan Clamp, has also written a blog for the hub on the report, which can be read here. -
Content ArticleIn this report the Professional Standards Authority for Health and Social Care sets out its view on the biggest challenges affecting the quality and safety of health and social care. It puts forward a number of recommendations to ensure safer care for all, with its main recommendation being that an independent Health and Social Care Safety Commissioner should be appointed for each UK country to identify current, emerging and potential risks across the whole health and social care system, and bring about the necessary action across organisations.
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Content ArticleFor the first time since the 1990s, the Surgeons’ Hall Museums in Edinburgh has displayed a new pathology specimen—a transvaginal tape removed in April 2022 from a woman suffering complications of vaginal tape (or mesh) surgery performed in 2006. In this blog Louise Wilkie, the museums' Curator, explains how the device came to be displayed, the history of vaginal tape surgery and the controversy surrounding its introduction and regulation. She also highlights concerns about the subsequent treatment of women who experienced life-changing complications as a result of the procedure.
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Content ArticleIn this article, Anubha Taneja Mukherjee, Group Member Secretary of Thalassemia Patients Advocacy, writes about patient safety issues surrounding blood donation and transfusion in India. She looks at several recent cases of children with thalassemia being infected with HIV while having blood transfusions, and highlights growing concern about lack of regulation and inconsistent testing of donated blood in India. She argues that blood banks should use additional screening such as the Nucleic Acid Amplification Test (NAT) to provide a safety net and ensure that blood containing infectious diseases—such as HIV, hepatitis B and C, syphilis and malaria—is not unwittingly given to patients.
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Content ArticleThe results of NHS Providers’ annual survey on regulation offer a strong endorsement of the change in approach that regulators’ are trying to make to reflect a new context of system – but the survey also reflects the fact that trusts’ experience of regulation over the past year still doesn’t match the vision the national bodies have set out. In this HSJ article, Mariya Stamenova emphasises the importance of implementing regulations to ensure systematic and efficient functioning within the NHS Framework.
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In this joint blog, Patient Safety Learning and Sling the Mesh highlight several issues with the specialist mesh centres set up by the NHS to provide treatment and surgery for women who have been harmed by mesh. We identify key patient safety issues and look at what needs to be done to ensure women receive timely, compassionate and appropriate treatment for complications they face as a result of mesh implants. -
Content ArticleVaginal tapes, slings and meshes are medical devices that are surgically implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. This report written on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA) by York Health Economics Consortium, provides summaries of safety and adverse events related to vaginal tapes for SUI and POP. The summaries were developed using the data reported in systematic reviews of the effects and safety of vaginal tapes published in the 10 years up to 2012.
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Content ArticleThe Health and Care Act 2022 and reforms to the public health system have introduced a range of changes and some simplifications to the landscape of national bodies in the health and care system. This blog explains the core functions of the national bodies with the most significant role in setting policy for and shaping the operation of the health and care system. It also looks at how these organisations are held accountable for carrying out those functions and the extent to which central government can direct them.
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Content ArticleThe General Medical Council (GMC) is the UK's statutory body responsible for taking action to prevent a doctor from putting the safety and confidence of patients at risk. In this blog for The Spectator, doctor Max Pemberton argues that the GMC has lost the trust of doctors by bringing a series of inappropriate cases, resulting in the British Medical Association (BMA) calling for an overhaul of how the GMC is run. He describes some recent investigations as being about 'petty' issues and highlights the significant impact being under investigation can have on doctors' mental health.
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Content ArticleThis document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning. It also identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. This document also establishes a coherent concepts and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.
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Content ArticleThe Professional Standards Authority (PSA) are an independent body, accountable to the UK Parliament. PSA helps to protect the public through their work with organisations that register and regulate people working in health and social care: PSA oversee 10 statutory bodies that regulate health and social care professionals in the UK. PSA accredit registers of health and care professionals held by non-statutory bodies. PSA aim to improve regulation by providing advice to UK government and others, conducting/ commissioning research and promoting the principles of right-touch regulation. Here is a snapshot of the work they have done in 2020/21.
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Content ArticleThe Professional Standards Authority (PSA) performance reviews look at a regulators’ performance against PSA's Standards of Good Regulation, which describe the outcomes regulators are expected to achieve. They cover the key areas of the regulators’ work, together with the more general expectations about the way in which regulators are expected to act. Here is the review of the General Osteopathic Council performance review.
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Content ArticleThe Professional Standards Authority (PSA) performance reviews look at a regulators’ performance against PSA's Standards of Good Regulation, which describe the outcomes regulators are expected to achieve. They cover the key areas of the regulators’ work, together with the more general expectations about the way in which regulators are expected to act. Here is the review of the Health and Care Professions Council performance review.
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Content ArticleThe International Electrotechnical Commission (IEC) is a worldwide organisation for standardisation comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardisation in the electrical and electronic fields. This part of IEC 62366 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
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Content ArticleIn this British Journal of Nursing article, John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent reports on the duty of candour and shared decision-making.
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Content ArticleThis article in DIA Global Forum examines a new collaboration between the European Commission, the European Medicines Agency (EMA) EU Member States Belgium, France, and Germany, the Bill & Melinda Gates Foundation and the recently established African Medicines Agency (AMA). The group will mobilise more than €100 million over the next five years to support the AMA and other African medicines regulatory initiatives at regional and national levels. The initiative will foster collaboration and sharing of technical expertise by European regulators with AMA. It also aims to assist African national regulatory authorities (NRAs) in achieving the minimum World Health Organization (WHO) requirements for effective regulatory oversight of quality-assured, safe, local production of medicines and vaccines.
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Content ArticleIn this blog, Chris Day, Director of Engagement at the Care Quality Commission (CQC) sets out more detail on the CQC’s role in the assessment of Integrated Care Systems (ICSs). He highlights the importance of developing regulation that earns the trust of both people using services and those working in them. He outlines how the CQC will use its new responsibilities under the Health and Care Act 2022 to assess the extent to which each ICS understands the needs of its local population and whether it is working effectively in collaboration, with valued input from all health and care partners.
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Content ArticleCognition is the mental process of knowing, including awareness, perception, reasoning and judgement, and is distinct from emotion and volition. Cognitive processes include mental shortcuts, which speed up decision making. However, cognitive bias occurs when the shortcut causes inferences about other people and/or situations to be drawn in an illogical fashion. There is a tendency to display bias in judgements that are made in everyday life, indeed this is a natural element of the human psyche. Jumping to a conclusion, tunnel vision, only seeing what is expected/wanted, being influenced by the views of others, all are recognisable behaviours. However, whilst such biases may be commonplace and part of human nature, it is essential to guard against these in forensic science, where many processes require subjective evaluations and interpretations. The consequences of cognitive bias may be far-reaching; investigators may be influenced to follow a particular line of enquiry or interpretation of a finding that may be incomplete, or even wrong. Simply because there is a risk of a cognitive bias does not imply that it occurs. The problem is that as it is a subconscious bias it is unlikely that an individual will know either way and therefore it is wise that all practitioners understand the issue and take proportionate steps to mitigate against it.
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Content ArticleThe Forensic Science Regulator publishes lessons that can be learnt from quality failings.
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Content ArticleThe Medicines and Healthcare product Regulatory Agency’s (MHRA) Annual Report and Accounts for 2021/22 has now been published. It provides an overview of MHRA's performance and the events that have had most impact on the Agency during the past year.
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Content ArticleIn this article, Kamran Abbasi, editor in chief of the BMJ outlines the need for reform to the General Medical Council (GMC), which is responsible for regulating doctors in the United Kingdom. He talks about how the GMC received a significant backlash from doctors after its handling of the case of Manjula Arora, a GP who was disciplined for a word she used when asking her employer for a laptop. However, he highlights that the GMC's issues started long before this case, with racial bias, discrimination and an adversarial culture present over the last 30 years. Kamran also outlines measures that should be taken to ensure organisational change and accountability for the GMC.
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Published on 19 October 2022, the report of the investigation into maternity and neonatal services at East Kent Hospitals NHS Foundation Trust revealed a series of serious patient safety failings between 2009 and 2020, which resulted in avoidable harm to patients and deaths. The investigation found that if nationally recognised standards had been followed, the outcome could have been different in 97 of the 202 cases reviewed. In this article, Patient Safety Learning analyses the findings of this report from a broad patient safety perspective, focusing on five key themes that are consistent with many other serious patient safety inquiries and reports in recent years. It sets these in their wider context and highlights the need for a fundamental transformation in our approach to patient safety if similar scandals are to be prevented in the future.- Posted
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Content ArticleNHS chiefs and regulators have written to hospital bosses admitting winter could be so bad NHS staff may have to "depart from established procedures" to care for patients. Letter says regulators will take the challenging situations into context...
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Content ArticleThe APPG held their annual general meeting in Parliament. Baroness Cumberlege was re-elected as Co-Chair of the group and in light of Jeremy Hunt’s recent appointment as Chancellor of the Exchequer, Sharon Hodgson MP was elected as Co-Chair, having previously supported the Group as Vice-Chair over the last calendar year. Sharon is is an Officer of the APPG for Valproate and other Anti-Epileptic Drugs in Pregnancy and Vice-Chair of the All-Party Parliamentary Group on Surgical Mesh. The current serving Vice-Chairs were re-elected, with the addition of Baroness Ritchie also joining as Vice-Chair. The Group looked back on a year of significant activity and progress, including the appointment of Dr Henrietta Hughes as the first Patient Safety Commissioner in England, and agreed that a renewed focus on seeking the implementation of redress schemes should be a priority for the Group over the next year.
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