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News Article
MHRA warns of pregabalin ‘breathing difficulties’
Patient Safety Learning posted a news article in News
Pregabalin may be associated with serious breathing problems in patients with compromised respiratory systems, according to a drug safety alert from the medicines regulator. Elderly patients, patients with neurological disease, renal impairment and those who are taking antidepressant medication are also at increased risk of breathing problems from the drug, the Medicines Healthcare Regulatory Agency (MHRA) said (18 February). Pregabalin is a medication that has increasingly been prescribed to treat chronic pain, however, it is also used to treat epilepsy, fibromyalgia, restless leg syndrome, and generalised anxiety disorder. The use of pregabalin combined with central nervous system depressants such as opioids has been associated with an increased risk of respiratory failure, coma, and deaths since 2018, said the MHRA. However, a recent review of the safety of the drug has found that the use of pregabalin alone can also cause ‘severe’ respiratory depression. "The review identified a small number of worldwide cases of respiratory depression without an alternative cause or underlying medical conditions. In these cases, respiratory depression had a temporal relationship with the initiation of pregabalin or dose increase. Other cases were noted in patients with risk factors or underlying medical history. The majority of cases reviewed were reported in elderly patients," the alert said. Health professionals have been advised to consider adjustments in dose or dosing regimen are necessary for patients at higher risk of respiratory depression. The alert also told them to report suspected adverse drug reactions associated with the use of pregabalin via the Yellow Card website. Existing advice asks healthcare professionals to check the patient for a history of drug abuse before prescribing pregabalin and to observe patients who have been prescribed the drug for signs of drug abuse and dependence. Read full story Source: Pulse, 23 February 2021 -
Content ArticleThe Healthcare Safety Investigation Branch (HSIB) carried out a themed review of their maternal death investigations during the coronavirus (COVID-19) pandemic. The national learning reports can be used by healthcare leaders, policymakers, and the public to: Aid their knowledge of systemic patient safety risks. Understand the underlying contributing factors. Inform decision making to improve patient safety. Explore wider patient safety processes.
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Content ArticlePrevention of Future Deaths Reports (PFDs) made by coroners to address concerns arising from inquests can provide powerful leverage for change, although the reality is that health and social care organisations would generally rather avoid a PFD if possible because they also highlight - in a very public way - concerns about how their services operate which can, in turn, lead to further regulatory scrutiny, principally from the CQC. The need for more consistency in terms of thresholds for making PFDs and the form these take, plus the Chief Coroner’s strong commitment to ensuring that PFDs do what they are designed to do - i.e. harness learning from deaths - have been key drivers behind a recent re-vamping of the existing Chief Coroner’s guidance note on this. What do health and social care organisations need to know about the revised PFD guidance? This briefing looks in more detail about what’s changed (and what hasn’t).
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Content ArticleThis is the first in a series of thematic reports which will be published by the Independent Maternity Services Oversight Panel in the coming year. The purpose of the report is to summarise the learning which is emerging from the ongoing programme of independent clinical reviews of the maternity and neonatal care previously provided by the former Cwm Taf University Health Board. This particular report summarises the key themes and issues which emerged from the clinical review of 28 individual episodes of care1 which were provided by the Health Board between 01 January 2016 and 30 September 20182. It focuses on the care of mothers who needed unplanned emergency treatment during childbirth, including some who required admission to an Intensive Care Unit.
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News Article
UK hospitals failing to follow guidelines on group B Strep
Patient Safety Learning posted a news article in News
Failures to follow national guidelines to prevent group B Strep infections in newborn babies is leading to a postcode lottery of care and opportunities to stop deadly infections being missed, a new report has found. Nearly 90% of hospitals in the UK are not using the recommended test for GBS carriage – which costs around £11- despite clear guidance issued by the Royal College of Obstetricians and Gynaecologists (RCOG) and Public Health England (PHE) that the test can significantly decrease false-negative results. Group B Strep is the UK’s most common cause of severe infection in newborn babies, causing sepsis, pneumonia, and meningitis. Approximately 800 babies a year in the UK develop group B Strep infection in their first 3 months of life, 50 babies will die, with another 70 survivors left with life-changing disabilities. Most of these infections could be prevented. Only a tiny number of NHS Trusts are following the key new recommendations around giving pregnant women information on group B Strep, offering testing to some pregnant women, and following Public Health England guidelines on testing for group B Strep. As a result, pregnant women face a postcode lottery, potentially receiving significantly different care from recommended practice. Read full story Source: Group B Strep Support, 1 February 2021 -
Content ArticleThe Royal College of Obstetrics and Gynaecology (RCOG) has guidance on group B Strep infection in newborn babies, which was last updated in September 2017. A national learning published earlier in 2020 by the Healthcare Safety Investigation Branch (HSIB) highlighted that the RCOG guidance was not being followed. This report from the Group B Strep Support reinforces these findings. Only a tiny number of NHS Trusts are following the key new recommendations around giving pregnant women information on group B Strep, offering testing to some pregnant women, and following Public Health England guidelines on testing for group B Strep. As a result, pregnant women face a postcode lottery, potentially receiving significantly different care from recommended practice. Group B Strep Support recommends that the NHS prioritises the prevention of group B Strep infection in newborn babies. A key step towards this would be to ensure published national guidance from recognised expert bodies is adopted and implemented in a timely manner.
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Content ArticleThe Royal College of General Practitioners has updated its guidance on online consultations. The resource gives a useful set of questions to consider when using online consultations, such as which provider is used, the standard of patient care, and ensuring equitable access.
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Content ArticleThe World Health Organization (WHO) has recently published, for consultation, the third draft of its Global Patient Safety Action Plan 2021-2030. In this blog, Patient Safety Learning reflects on areas where our initial feedback in September 2019 has been incorporated into the new draft and where we believe the Action Plan can be further strengthened
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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 -
News ArticleAt least seven so-called NHS “never events” should be reclassified because the health service has failed to put in place effective measures to stop them from repeatedly happening, safety experts have said. The independent Healthcare Safety Investigation Branch (HSIB) said NHS England should remove the never event incidents from the list of 15 it requires hospitals to report, because they are not “wholly preventable” and the NHS has not adequately recognised the systemic risks that mean they keep happening. The errors include examples such as a 62-year-old man having the wrong hip replaced during surgery and a nine-year-old girl who was given a drug by injection that should have been given by mouth. Other incidents included a woman who had a vaginal swab left inside her following the birth of her first child and a 26-year-old man who had a feeding tube accidentally inserted into his lung rather than his stomach. In a new report, investigators from HSIB carried out a detailed analysis of seven incidents it has investigated which account for the majority of never events recorded by NHS hospitals in 2018-19. NHS England claims there are steps hospitals can take that mean the errors should never happen but HSIB says many of the steps are administrative, such as a checklist, and do not fully take into account the environment staff work in, the nature of the errors or how they happen. Read full story Source: The Independent, 21 January 2021
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Content Article‘Never events’ are patient safety incidents that are defined as being wholly preventable. They are considered wholly preventable because guidance or safety recommendations are in place at a national level and should have been implemented by all providers in the healthcare system. This should act as a strong systemic barrier to prevent the serious incident from happening. The latest national report from the Healthcare Safety Investigation Branch (HSIB) says that 'Never Events' should not be defined as such if they don’t have strong enough barriers in place to stop them happening.It recommends that seven Never Events on a list of 15 should be removed until better barriers are in place. They are using the Safety Engineering Initiative for Patient Safety (SEIPS) model to carry out the analysis. SEIPS provides a framework for understanding structures, processes and outcomes in healthcare, and their relationships.
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Content ArticleSurgical site infections (SSIs) present a considerable challenge for healthcare systems across the world, including in the UK, and have a substantial impact on patients and healthcare professionals. Despite clear evidence and guidelines on how to reduce the risk of these infections on a global, regional and national basis – and the fact that research shows up to 60% of SSIs are preventable – infection rates remain high. Progress has been made in recent years, yet more than 5% of patients undergoing a surgical procedure still develop an SSI, and each infection has been estimated to cost the NHS between £10,0003 and £100,000 per patient. It is now time to act. Collectively we need to reduce the variation in practice across the UK, embed evidence-based examples of best practice, and work collaboratively with the NHS to help reduce the incidence of SSIs to improve patient outcomes. Embedding this guidance and changes to practice cannot take place in silos. It will require action from the whole healthcare community: from policymakers, to trusts, to hospitals, healthcare professionals and medical Royal Colleges, right the way through to the patient themselves. This report, Time to Act: A State of the Nation report on Surgical Site Infections in the UK, will review the available evidence, examples of best practice and reflections from the front line, to make recommendations to each of these groups in order to drive significant improvement in reducing SSI rates in the UK.
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Content ArticleWorld Health Organization (WHO) presentation summarising the global guidelines and recommendation for the prevention of surgical site infections.
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News ArticleIn July last year, the Independent Medicines and Medical Devices Safety Review – chaired by Baroness Cumberlege— published its landmark report, First Do No Harm. It followed a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh. Yesterday, in a written statement to Parliament, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, gave an update on the government’s response to the recommendations of the Cumberlege Review. In an article in The Times today, Baroness Cumberlege welcomes that the government has now accepted the need for a patient safety commissioner for England and the amendment to the Medicines and Medical Devices Bill, which is being considered in the House of Lords today, which she hopes "will swiftly become law". However, she also states that "... a full response to the review's is still outstanding 6 months after publication. Action is urgently needed to ensure we help those who have already suffered and reduce the risk of harm to patients in future". Read full story (paywalled) Source: The Times, 12 January 2021
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Content ArticleThe Care Quality Commission (CQC) has published the second report of Professor Glynis Murphy’s independent review of its regulation of Whorlton Hall between 2015 and 2019. CQC commissioned Professor Murphy to conduct an independent review to look at whether the abuse of patients at Whorlton Hall could have been recognised earlier by the regulatory process and to make recommendations for how CQC can improve its regulation of similar services in the future. In addition, CQC asked Professor Murphy to conduct a review of international research evidence to look at how abuse is detected within services for adults with a learning disability and autistic people and how such detection can be improved. The first report of Professor Murphy’s review made a number of recommendations for CQC to strengthen its inspection and regulatory approach for mental health, learning disability and/or autism services. This second report outlines the progress that CQC has made to implement the recommendations. This includes publication of the final report of its review of restraint, seclusion and segregation; work on closed cultures and the development of a tool for rating support plans.
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News ArticleIn a Letter to the Editor published in The Times yesterday, the All Party Parliamentary Group on First Do No Harm Co-Chair Baroness Julia Cumberlege argues in favour of the work of the Independent Medicines and Medical Devices Safety (IMMDS) Review and its report 'First Do No Harm'. "Inquiries are only as good as the change for the better that results from their work." Read full letter (paywalled) Source: The Times, 5 January 2021
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News ArticleNHS guidance ‘too long to read,’ say hospital staff as safety watchdog exposes systemic risks to patients. The Healthcare Safety Investigation Branch (HSIB) revealed some NHS staff had admitted not reading official guidance on how to avoid the ‘never event’ error as part of a new report identifying deeper systemic problems that it said left patients at an increased risk. The independent body warned patients across the NHS remained vulnerable to being injured or even killed by the error that keeps happening in hospitals despite warnings and safety alerts over the last 15 years. HSIB launched a national investigation into the problem of misplaced nasogastric (NG) tubes after a 26-year-old man had 1,450ml of liquid feed fed into his lungs in December 2018 after a bike accident. The patient recovered but the error was not spotted, even after an X-ray. Read full story Source: The Independent, 17 December 2020
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Content ArticleThe latest Healthcare Safety Investigation Branch (HSIB) report focuses on the life-threatening risk posed by the accidental misplacement of tubes that deliver food or medication to critically ill patients.
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News Article
Shropshire baby deaths: Hospitals must adopt new safety steps
Patient Safety Learning posted a news article in News
All NHS trusts in England have been given a deadline of Monday to enact safety improvements in maternity care amid Shropshire's baby deaths scandal. Heath chiefs have told hospitals they must have the 12 "urgent clinical priorities" in place by 17:00 GMT. The move is to address "too much variation" in outcomes for families. It comes during a probe into the maternity care of more than 1,800 families in Shropshire. The inquiry, launched amid concerns of repeated failings at Shrewsbury and Telford Hospital NHS Trust (SaTH), focuses on the experience of 1,862 in total, and includes instances of infant fatality. An interim report published last week found poor care over nearly two decades had harmed dozens of women and their babies. The report called for seven "essential actions" to be implemented at maternity units across England. But that has since been transformed into 12 clinical tasks, including giving women with complex pregnancies a named consultant, ensuring regular training of fetal heart rate monitoring, and developing a proper process to gather the views of families. The directions are revealed in a letter in which NHS England says there is "too much variation in experience and outcomes for women and their families". Read full story Source: BBC News, 15 December 2020 -
News ArticleStrong leadership, challenging poor workplace culture, and ringfencing maternity funding are key to improving safety. That’s the message from two leading Royal Colleges as they respond to the independent review of maternity services at Shrewsbury and Telford NHS Trust led by Donna Ockenden. The RCOG and the Royal College of Midwives (RCM) have today welcomed the Ockenden Review and its recognition of the need to challenge poor working relationships, improve funding and access to multidisciplinary training and crucially to listen to women and their families to improve learning and to ensure tragedies such as those that have happened at Shrewsbury and Telford NHS Trust never occur again. The Colleges have said that the local actions for learning and the immediate and essential actions laid out in this report must be read and acted upon immediately in all Trusts and Health Boards delivering maternity services across the UK. Commenting, Dr Edward Morris, President of the Royal College of Obstetricians and Gynaecologists, said: “This report makes difficult reading for all of us working in maternity services and should be a watershed moment for the system. Reducing risk needs a holistic approach that targets the specific challenges of fetal monitoring interpretation and strengthens organisational functioning, culture and behaviour." Read press release Source: RCOG, 10 December 2020
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Content ArticleSerious complications and deaths resulting from maternity care have an everlasting impact on families and loved ones. The families who have contributed to the Ockenden Review want answers to understand the events surrounding their maternity experiences, and their voices to be heard, to prevent recurrence as much as possible. They are concerned by the perception that clinical teams have failed to learn lessons from serious events in the past. The learning of lessons and embedding of meaningful change at The Shrewsbury and Telford Hospital NHS Trust and in maternity care overall is essential both for families involved in this review and those who will access maternity services in the future. After reviewing 250 cases and listening to many more families, this first report identifies themes and recommendations for immediate action and change, both at The Shrewsbury and Telford Hospital NHS Trust and across every maternity service in England.
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Content ArticleJames Titcombe, Patient Safety Campaigner and co-founder of Harmed Patients Alliance, discusses the findings of the recent Bill Kirkup report 'The Life and Death of Elizabeth Dixon: A Catalyst for Change'.
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Content ArticleThis Healthcare Safety Investigation Branch (HSIB) report charts the emerging patient safety risks that can come with the introduction of ‘smart’ infusion pump technology into hospitals. Smart infusion pumps are the latest generation of programmable devices that administer medication. They are seen as a way of improving safety as the smart functionality aims to prevent underdoses or overdoses – they are equipped with features such as alerts or alarms to help detect problems. The investigation was launched after one NHS Trust recorded three incidents where a smart infusion pump delivered an overdose of fentanyl, a powerful pain medication. The patients weren’t harmed as it was swiftly picked up, however it emphasised the new risks that come with introducing new technology and the potential for serious medication errors. The investigation focused on the barriers to implementing the technology effectively across the NHS, rather than on the technology itself.
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Content ArticleLaura Anne Jones MS (Member of the Senedd) tabled a formal written question concerning the implementation of the findings of the Cumberlege Review in Wales. This is the formal response from the Minister for Health and Social Services, Vaughan Gething MS.
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News Article
Elizabeth Dixon death inquiry 'exposes 20-year cover-up' of mistakes
Patient Safety Learning posted a news article in News
The death of a premature baby in 2001 led to a "20-year cover-up" of mistakes by health workers, an independent inquiry has found. Elizabeth Dixon, from Hampshire, died due to a blocked breathing tube shortly before her first birthday. The government, which ordered the inquiry in 2017, said the mistakes in her care were "shocking and harrowing". The inquiry report by Dr Bill Kirkup said some of those involved had been "persistently dishonest". Elizabeth, known as Lizzie, died from asphyxiation after suffering a blockage in her tracheostomy tube while under the care of a private nursing agency at home. Dr Bill Kirkup, who was appointed by the government to review the case, said her "profound disability and death could have been avoided". He said: "There were failures of care by every organisation that looked after her, none of which was admitted at the time, nor properly investigated then or later." "Instead, a cover-up began on the day that she died, propped up by denial and deception." Read full story Source: BBC News, 26 November 2020 Patient Safety Learning's statement on the Dixon Inquiry report
