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Keep up to date with the latest news, research and activity in patient safety.

Republic of Korea achieves the highest WHO level for regulation of medicines and vaccines

The World Health Organization (WHO) announces that the Ministry of Food and Drug Safety, Republic of Korea, has achieved maturity level four (ML4), the highest level in WHO’s classification of regulatory authorities for medical products. WHO has formally assessed the medical product regulatory authorities of 33 countries, of which only the Republic of Korea is listed as attaining this level in regulation for both locally produced as well as imported medicines and vaccines.
This achievement represents an important milestone for the Republic of Korea and for the world, signifying that the Ministry of Food and Drug Safety (MFDS), the national regulatory authority for medicines and vaccines, is operating at an advanced level of performance with continuous improvement
Only about 30% of the world’s regulatory authorities have the capacity to ensure medicines, vaccines and other health products are produced to required standards, work as intended and do not harm patients. WHO’s benchmarking efforts identify regulatory authorities that are operating at an advanced level so that they can act as a reference point for regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight. 
“This is a great testament for Republic of Korea’s commitment for ensuring safe and effective medicines and vaccines, and investing in building a strong regulatory system,” said Dr Mariângela Simão, Assistant Director-General, Access to Medicines and Health Products. “We hope the achievement will be sustained and also help promote confidence, trust and further reliance on national authorities attaining this high level”.
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Source: WHO, 29 November 2022
Patient Safety Learning

Doctors raise safety fears at Birmingham hospitals

Whistleblowers at one of England's worst performing hospital trusts have said a climate of fear among staff is putting patients at risk.
Former and current clinicians at University Hospitals Birmingham (UHB) NHS Trust allege they were punished by management for raising safety concerns, a BBC Newsnight investigation found.
One insider said the trust was "a bit like the mafia".
The trust said it took "patient safety very seriously". It said it had a "high reporting culture of incidents" to ensure accountability and learning.
Staff concerns included a dangerous shortage of nurses and a lack of communication leading to some haematology patients dying without receiving treatment.
The deaths of 20 patients in the haematology department of the Queen Elizabeth Hospital, which is run by the trust, led to a review in 2017 by consultant Emmanouil Nikolousis.
Mr Nikolousis, who left the trust in 2020, told the BBC he was shocked by the failings he found and believes patients' lives could have been saved.
A report by Mr Nikolousis criticised a lack of "ownership" of patients and a lack of communication among senior clinicians. In some cases this led to patients dying without having received treatment, he said.
"Certainly there should have been different actions done," he said. "They could be saved. Certainly, when you don't have an action done, then you don't really know the outcome."
Mr Nikolousis said he felt he had no option but to quit after his findings were ignored and his position was made "untenable". He left the NHS after 18 years.
"They were trying, as they did with other colleagues, to completely sort of ruin your career," he said.
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Source: BBC News, 1 December 2022
 
Patient Safety Learning

Thousands of referrals for sick babies turned down due to lack of beds

More than 1,000 referrals to admit very sick or premature babies to neonatal units were rejected in the last year due to a lack of beds, data obtained by HSJ has revealed.
Nineteen trusts turned down a total of 2,721 requests to admit a baby to their level three neonatal intensive care unit – those for the most serious cases – specifically due to a lack of a bed, between 2019-20 and 2021-22, with 1,345 such refusals taking place in 2021-22.
Experts told HSJ the issue – which appears to have led to families having to travel very long distances from their homes – was due to a shortage of staff, especially nurses, meaning insufficient beds (normally referral to as cots in neonatal care) can be opened.  
A British Association of Perinatal Medicine spokesperson told HSJ: “Neonatal intensive care units should run at less than 80% occupancy on average to allow for peaks and troughs in activity. There are a significant number which are having to run over that capacity limit which can cause flow problems – we’re a bit like an A&E that can’t stack the ambulances outside – once the baby is there, it has to come and we’re not able to control those admissions.”
Read full story (paywalled)
Source: HSJ, 1 December 2022
Patient Safety Learning

Germany faces ‘catastrophic’ paediatric bed shortage as RSV cases soar

Intensive care doctors in Germany have warned that hospital paediatric units in the country are stretched to breaking point in part due to rising cases of respiratory infections among infants.
The intensive care association DIVI said the seasonal rise in respiratory syncytial virus (RSV) cases and a shortage of nurses was causing a “catastrophic situation” in hospitals.
RSV is a common, highly contagious virus that infects nearly all babies and toddlers by the age of two, some of whom can fall seriously ill. Experts say the easing of coronavirus pandemic restrictions means RSV is affecting a larger number of babies and children, whose immune systems aren’t primed to fend it off.
Cases of RSV and other respiratory illnesses have also increased in the UK and in the US, which is also suffering from a shortages of antivirals and antibiotics.
In Germany, hospital doctors are having to make difficult decisions about which children to assign to limited intensive care beds. In some cases, children with RSV or other serious conditions are getting transferred to hospitals elsewhere in Germany with spare capacity.
“If the forecasts are right, then things will get significantly more acute in the coming days and week,” Sebastian Brenner, head of the paediatric intensive care unit at University Hospital Dresden, told German news channel n-tv. “We see this in France, for example, and in Switzerland. If that happens, then there will be bottlenecks when it comes to treatment.”
Others warned that, in certain cases, doctors already were unable to provide the urgent care some children need.
“The situation is so precarious that we genuinely have to say children are dying because we can’t treat them any more,” Dr. Michael Sasse, head of paediatric intensive care at Hanover’s MHH University hospital, said.
Read full story
Source: The Guardian, 1 December 2022
Patient Safety Learning

What ambulance strike means for calls, response times and staffing

Ambulance services across England are set to go on strike before Christmas as thousands of paramedics and call handlers voted for action.
The announcement by union Unison comes as the Royal College of Nursing (RCN) confirmed 100,000 nurses across England, Wales and Northern Ireland will walk out on 15 and 20 December.
The union is calling for action on pay and a big increase in staff numbers, warning that unless these things happen, services will continue to decline.
Saffron Cordery, interim chief of NHS Providers, said on BBC radio four: “I think in terms of the ambulance strike, we know the challenges already of not having enough paramedics, call handlers available, because we’ve seen the challenges to ambulance handover times that we have at the moment in terms of not being able to transfer patients from ambulances into A&E departments and the challenges that brings when they can’t get back out on the road.
“Additional challenges on top of that, I think, will make response times incredibly stretched.”
Sources told The Independent that one option could be for services to maintain levels of staff to be able to respond to the most serious calls - category one and two calls - and deprioritise the less serious category three and four calls.
This has previously been negotiated during smaller-scale strikes.
However, senior sources suggested that on a larger scale it would be hard to not respond to category three calls, which might include an older person who has fallen.
It is also unclear how 999 call centres would operate during strikes as this work would likely count as life-saving emergency care, The Independent understands.
Read full story
Source: The Independent, 2 December 2022
Patient Safety Learning

My mum's 40-hour wait to get to A&E with hip break

When 85-year-old Koulla fell at home, her family immediately rang for an ambulance. She was in agonising pain - she had broken her hip.
It was around 8pm. It took another 14 hours for an ambulance to get to her, leaving her pregnant granddaughter to care for her through the night.
When they arrived the crews were able to give her pain relief and quickly transported her to the Royal Cornwall Hospital.
But there the wait continued - there were around 30 ambulances queuing to handover patients to A&E staff.
It was another 26 hours before she was taken inside to A&E.
She then faced many hours in A&E before being taken for surgery.
Koulla's daughter, Marianna Flint, 53, said: "It was awful. You feel helpless because you're giving your trust over to them to look after a family member who's in agony and who needs surgery."
She has since received a written apology from the Royal Cornwall for the care provided to her mother in August.
Ms Flint said: "I almost feel sorry for those looking after her. It's not down to them. There was no room inside to accept her in."
Read full story
Source: BBC News, 1 December 2022
Patient Safety Learning

NHSE director demands maternity consultants work nights

The deputy chair of NHS England has said it should be as ‘demanding’ of medical cover in obstetrics and neonatal care as it is for emergency departments, to improve safety in the wake of repeated care scandals.
Sir Andrew Morris, who was the long-serving chief executive officer of the well-regarded Frimley Health Foundation Trust, said the service would “expect a consultant to be on duty in an emergency department [from] 8am till 10pm, or midnight, seven days a week”.
Speaking at NHS England’s public board meeting yesterday, Sir Andrew said: “We haven’t set that similar expectation out for [maternity care]. I know we’re saying we’re expecting that two ward rounds are undertaken, each day, seven days a week, but that is very different to the service I think is appropriate for this type of semi-emergency operation, that most trusts run.
“I’d like us to be as demanding of organisations [in relation to obstetrics and neonatal] as we are for the emergency department.”
Read full story (paywalled)
Source: HSJ, 1 December 2022
Patient Safety Learning

Medical jargon putting patients in harm's way

Patients are struggling to understand their doctors because of confusing medical jargon, a study has found.
Almost 80% of people do not know that the word 'impressive' actually means 'worrying' in a medical context.
Critics said using the word borders on 'disrespectful' because 'we're describing something as impressive that is causing real harm for patients'.
More than one in five of respondents could not work out the phrase 'your tumour is progressing', which means a patient's cancer is worsening.
And the majority of participants failed to recognise that 'positive lymph nodes' meant the cancer had spread.
The word 'impressive' means something admirable to most people. But when physicians describe a chest X-ray as impressive, they actually mean it is worrying. Some 79% of study participants did not get this meaning. Only 44 participants correctly understood that a clinician was actually giving them bad news.  
Read full story
Source: Mail Online, 1 December 2022
Patient Safety Learning

Six children have died with Strep A bacterial infection

There have been five recorded deaths within seven days of an invasive Strep A diagnosis in children under 10 in England this season, the UK Health Security Agency has said.
A child under the age of 10 has also died in Wales after contracting the infection.
Group A strep bacteria can cause many infections, ranging from minor illnesses to deadly diseases, but serious complications and deaths are rare.
According to UKHSA data, there were 2.3 cases of invasive disease per 100,000 children aged one to four this year in England, compared with an average of 0.5 in the pre-pandemic seasons (2017 to 2019).
There have also been 1.1 cases per 100,000 children aged five to nine, compared with the pre-pandemic average of 0.3 (2017 to 2019).
The UKHSA said investigations are under way following reports of an increase in lower respiratory tract Group A Strep infections in children over the past few weeks, which have caused severe illness.
It added that there is no evidence to suggest a new strain of Strep A is circulating, and the increase is most likely related to high amounts of circulating bacteria and social mixing.
Read full story
Source: Sky News, 3 December 2022
Patient Safety Learning

Pelvic mesh victims left unsure of futures as legal fees threaten to slash class action payout

In September, Shine Lawyers won a $300 million settlement in two class actions over the failed mesh products by Johnson & Johnson Medical and Ethicon. However, the law firm is proposing to take up to $99.5 million from the payout in costs, just under a third of the total sum.
Of 11,000 women involved in the class action, Janelle Gale is one of 200 who is not happy with Shine Lawyers' compensation proposal. Representatives of the group said there was mass confusion over what compensation they might be eligible for and how many hoops they would have to jump through to receive a payment.
Despite having barely any leakage before her 2014 surgery, afterwards Janelle became heavily incontinent. She was a drag-racing champion, but that came to a halt. She said it destroyed her marriage, she couldn't have sex and she still can't work.
Read more
Source: ABC News, 3 December 2022
Patient-Safety-Learning

Climate of fear putting patients at risk, say doctors

Whistleblowers at one of England's worst performing hospital trusts have said a climate of fear among staff is putting patients at risk.
Former and current clinicians at University Hospitals Birmingham (UHB) NHS Trust allege they were punished by management for raising safety concerns, a BBC Newsnight investigation found. One insider said the trust was "a bit like the mafia."
The trust said it took "patient safety very seriously." It said it had a "high reporting culture of incidents" to ensure accountability and learning.
Staff concerns included a dangerous shortage of nurses and a lack of communication leading to some haematology patients dying without receiving treatment, an investigation by BBC Newsnight and BBC West Midlands found.
Read more
Source: BBC News, 2 December 2022
Patient-Safety-Learning

Health inequities lead to early death in many persons with disabilities

A new report by the World Health Organization shows evidence of a higher risk of premature death and illness among many persons with disabilities compared to others in the society. 
The Global report on health equity for persons with disabilities published today shows that because of the systemic and persistent health inequities, many persons with disabilities face the risk of dying much earlier—even up to 20 years earlier—than persons without disabilities.
They have an increased risk of developing chronic conditions, with up to double the risk of asthma, depression, diabetes, obesity, oral diseases, and stroke.  Many of the differences in health outcomes cannot be explained by the underlying health condition or impairment, but by avoidable, unfair and unjust factors.
Read more
Source: WHO, 2 December 2022
Patient-Safety-Learning

Wales ‘displaying a dangerous and growing reliance’ on agency nurses

The NHS in Wales could move to a model in which most or all nursing care is outsourced to private companies, if its increasing reliance on agency staff continues, a union report has claimed.
According to the Royal College of Nursing, the Welsh health service risks moving to a situation where it no longer directly employs staff to provide patient care. NHS Wales spent between £133m and £140m on agency nursing during 2021-22, based on different freedom of information (FOI) requests and official figures, the RCN’s report suggested.
RCN Wales said, “If this trend continues, Wales will move to a situation where NHS Wales no longer directly employs staff to provide patient care and instead moves to a model in which most or all nursing care is outsourced to private companies.”
Read more
Source: Nursing Times, 4 December 2022
Patient-Safety-Learning

Covid causing liver damage lasting months after infection, study finds

Covid is causing liver damage lasting months after infection, according to new research.
Researchers at Massachusetts General Hospital, Boston, discovered Covid-positive patients had a “statistically significant” higher liver stiffness than the rest of the population.
Liver stiffness could indicate long-term liver injury such as inflammation or fibrosis, the buildup of scar tissue in the liver.
Dr Firouzeh Heidari a Research Fellow at Massachusetts General Hospital, said their findings show damage caused by Covid persists for a long time. She said, “Our study is part of emerging evidence that Covid-19 infection may lead to liver injury that lasts well after the acute illness. We don’t yet know if elevated liver stiffness observed after Covid-19 infection will lead to adverse patient outcomes.”
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Source: The Independent, 4 December 2022
Patient-Safety-Learning

NHS must ‘urgently investigate disturbing’ figures on rape and sex assault in hospitals

The NHS should “urgently investigate” after Byline Times uncovered “disturbing” figures showing that more than 4,000 patients, visitors and NHS staff were raped or sexually assaulted in hospitals over the past four years, the Shadow Health and Social Care Secretary has said.
An investigation by Byline Times has unearthed that 4,100 patients, visitors and NHS staff were raped (1,364) or sexually assaulted (at least 2,744) in a hospital setting between January 2019 and September 2022–with 633 raped or assaulted while on a hospital ward. At least three of the incidents were against a female child aged under 13. 
Data from 31 police forces in England and Wales based on reported rapes and assaults revealed the scale of sexual violence within hospital settings, with victims including patients and staff members.
Labour’s Shadow Health and Social Care Secretary Wes Streeting said, “Hospitals ought to be safe places for patients and staff, but these disturbing findings show that is not the case for far too many people. The NHS should urgently investigate why these disgusting crimes are allowed to happen and on such a widespread scale.”
Read more
Source: Byline Times, 5 December 2022
Patient-Safety-Learning

Good social relations promote active and healthy aging in Europe, finds researcher

In the older European population, men, as well as those with lower socioeconomic status, weak social ties, and poor health, might experience more difficulties getting informal support and are considered to have a higher risk of worsening frailty state and lower quality of life. This reality is shown in a new doctoral thesis at Umeå university.
Read the full article here
Clive Flashman
Registered address: Patient Safety Learning, China Works SB203, 100 Black Prince Road Vauxhall, London, SE1 7SJ

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