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

More than 400 pregnant women prescribed topiramate in the past year

Between April 2021 and March 2022, more than 400 pregnant women were prescribed the anti-epileptic medicine topiramate, which has been found to cause congenital malformations, figures published by NHS Digital have revealed.
The data, published on 29 September 2022, covers prescribing of anti-epileptic drugs in females aged 0–54 years in England from 1 April 2018 through to 31 March 2022. Overall, it shows a reduction in the number of females prescribed sodium valproate; from 27,441 in April 2018 to 19,766 in March 2022.
However, the numbers also show that sodium valproate, which can cause birth defects, is still being prescribed during pregnancy, with 42 women being prescribed the drug at some point during their pregnancy between April 2021 and March 2022, compared with 43 in the previous year.
In addition, the data show that, during that same time period, 430 females were prescribed topiramate, which is used for treatment of migraines as well as epilepsy, during their pregnancy.
In 2021, a safety review, carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) found that carbamazepine, phenobarbital, phenytoin and topiramate were associated with an increased risk of major congenital malformations.
In July 2022, the MHRA launched a further review looking specifically at the safety of topiramate, after study results showed an increased risk of autism, developmental disorders and learning difficulties among babies exposed to the medicine during their mother’s pregnancy.
Daniel Jennings, senior policy and campaigns officer at Epilepsy Action, said it was “concerning” to see that prescribing figures for valproate had not decreased, compared with the previous year, and that despite the MHRA identifying other epilepsy medicines that could pose a risk if taken in pregnancy, there had been “little or no communication” about these risks.
“There is also still a large group of epilepsy medicines where we don’t have an adequate bank of evidence about their safe use during pregnancy,” he added.
“The MHRA and NHS England need to work together to communicate the risks and carry out research to protect women with epilepsy.”
Read full story
Source: The Pharmaceutical Journal. 7 October 2022
Patient Safety Learning

Patients turning to A&E as wait times for NHS mental health treatment spiral

Mental health patients are increasingly having to turn to A&E for help, experts have warned, as new research suggests nearly one in four are being forced to wait more than 12 weeks to start treatment.
The Royal College of Psychiatrists said its research found 43% of adults with mental illness say the long waits for treatment have led to their mental health getting worse. Almost a quarter (23%) have to wait more than 12 weeks to start treatment, with many so desperate they turn to A&E or dial 999.
The college said many people face a “hidden wait time” for starting treatment, with no publicly available data on how long people wait from their initial referral to actually starting treatment.
Those surveyed for the research had a range of mental illnesses, including eating disorders, addiction, bipolar disorder, anxiety and depression.
Dr Kate Lovett, the college’s presidential lead for recruitment, said: “We cannot sit idly by and watch the most vulnerable people in our society end up in crisis. Not only do spiralling mental health waiting times wreak havoc on patients’ lives, but they also leave NHS services with the impossible task of tackling rising demand.”
One female patient, a 45-year-old from south London, told how she ended up in A&E after having to wait seven months to be referred to a community team.
“The only other way to get help was to present to A&E, which was a traumatic experience – having to be reassessed and readmitted again and again. Turning up to A&E was the only way I could be seen regularly. No one should have to go through that.”
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Source: The Guardian, 10 October 2022
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NHS may cancel appointments and reduce visiting times over Covid and flu ‘twindemic’, leaders warn

NHS trusts may be forced to cancel appointments and limit visiting times in a Covid and flu “twindemic” this winter, health leaders have warned.
Fears have been raised the viruses could strip back the workforce and further increase demand for services during an already busy period.
It comes amid rising Covid infections in the UK. Around 1.3 million tested positive in late September, according to the latest figures, which was a 25% increase on the week before.
The UK is also concerned there could be a bad flu season this year, with lower immunity across the population due to reduced exposure in the Covid pandemic.
NHS leaders have warned that this background could make winter even more difficult for the health service.
“I make no bones about this: we know it’s going to be a pressurised time for trusts over the next four months if not longer,” Saffron Cordery from NHS Providers, which represents trusts in England, told The Independent.
The interim chief executive added: “We’re worried about Covid and we’re worried about flu.”
Ms Cordery said these joint pressures – which could increase demand, strip back workforces and introduce the need for greater infection control measures – could have a knock-on effect on services.
“We need to anticipate that there may well be cancellations for either outpatient appointments or routine procedures or operations, because there could be staff shortages or rising demand in emergency care – that means that those routine appointments cannot take place as quickly as we’d like,” she said.
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Source: The Independent, 8 October 2022
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NI 'needs mother and baby mental health unit'

An appeal to establish a dedicated Mother and Baby Perinatal Mental Health Unit will be delivered to the Nothern Ireland health minister later.
Individual women, charities and other organisations will hand over a public letter urging Robin Swann to act.
Northern Ireland is the only place in the UK which has no dedicated in-patient service for women with serious post-partum mental health issues.
The units admit mothers with their babies so that they can be with them.
About 70 women a year in Northern Ireland are admitted to hospital with post-partum psychosis. The health minister approved some funding for perinatal mental health last year. However, no decision has been made on in-patient services.
Read full story
Source: BBC, 10 October 2022
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Even mild Covid-19 during pregnancy ‘exhausts placenta and damages immune response’

Even mild cases of Covid-19 during pregnancy “exhaust” the placenta and damage its immune response, new research suggests.
The findings, which come as coronavirus cases are again on the rise in the UK, lend weight to multiple studies over the course of the pandemic linking the virus to a rise in dangerous pregnancy complications such as pre-eclampsia.
But the results of the study – the largest yet involving the placentas of infected women – may represent the “the tip of the iceberg” of how Covid-19 affects foetal or placental development, warned Dr Kristina Adams Waldorf, the senior author on the study, which was published last month in the American Journal of Obstetrics & Gynecology.
 
Early in the pandemic, it was widely assumed that the coronavirus did not harm the developing foetus because so few babies were born with the infection, said Dr Adams Waldorf, a professor of obstetrics and gynaecology at the University of Washington School of Medicine.
“But what we’re seeing now is that the placenta is vulnerable to Covid-19, and the infection changes the way the placenta works, and that in turn is likely to impact the development of the foetus,” explained the professor.
Read full story
Source: The Independent, 9 October 2022
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Children with Down Syndrome at up to 10-fold higher risk of diabetes

New research led by Queen Mary University of London (QMUL) and King's College London (KCL) has shown that children with Down Syndrome (DS) are up to 10 times more likely to be diagnosed with diabetes.
Although elevated rates of both type 1 diabetes and obesity in DS were already recognised, this is the first time that the incidence of these comorbidities has been mapped across the life span, in one of the biggest DS cohorts in the world.
The authors concluded: "Our study shows that patients with DS are at significantly increased risk of diabetes at a younger age than the general population, with more than four times the risk in children and young adults and more than double the risk in patients aged 25–44 years."
They added: "The underlying mechanisms for this increased susceptibility for diabetes in DS still need further investigation. A combination of factors, including genetic susceptibility, predisposition to auto- immunity, mitochondrial dysfunction, increased oxidative stress, and cellular dysfunction, are thought to contribute to this risk."
Corresponding author Andre Strydom, professor in intellectual disabilities at KCL, said: "This is the largest study ever conducted in Down Syndrome patients to show that they have unique needs with regards to diabetes and obesity, and that screening and intervention – including a healthy diet and physical activity – at younger ages is required compared with the general population.
"The results will help to inform the work of NHSE's LeDeR programme to reduce inequalities and premature mortality in people with Down Syndrome and learning disabilities."
Read full story
Source: Medscape UK, 5 October 2022
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Bullying, misogyny and sexual culture at Royal College of Nursing, inquiry finds

A damning inquiry into the Royal College of Nursing, the world’s biggest nurses’ union, has exposed bullying, misogyny and a sexual culture where women are at risk of “alcohol and power-related exploitation”.
A 77-page internal report by Bruce Carr KC, leaked to the Guardian, lays bare how the RCN’s senior leadership has been “riddled with division, dysfunction and distrust” and condemns the male-dominated governing body, known as council, as “not fit for purpose”.
Grave concerns are also raised about the RCN’s annual conference, known as congress, where Carr says an “inappropriate sexual culture” warrants further urgent investigation “to identify the extent to which [it] has actually resulted in exploitation of the vulnerable”.
The eminent barrister reports that there is evidence to support the “impression” that senior individuals have been seeking to take sexual advantage of subordinates and “engaging in unwanted sexual behaviours”.
He calls on those whose conduct is cited in the report, whom he does not name, to consider their positions in the light of testimony of groping, humiliation of female staff members and a refusal of those in positions of responsibility to reflect on the letters of resignation from women on the council, who have complained of “gaslighting and microaggressions”.
Read full story
Source: The Guardian, 10 October 2022
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Social care ‘on its knees’ as vacancies hit record high

Social care services face an “absolute crisis” over record vacancies as unfilled jobs have risen by more than 50% in a year, a new analysis reveals.
New data on social care workers shows at least 165,000 vacancies across adult social care providers at the end of 2021-22.
This is the highest on record according to the charity Skills for Care, which has collected the data since 2012.
Leading think tanks have warned the figures to point to the “absolute crisis” facing social care with the “system on its knees”.
At the same time the demand for care has risen, highlighting that social care is facing a complex challenge with recruitment and retention which will be impacting on the lives of people who need social care. The annual report by Skills for Care predicts social care services will need an extra 480,000 workers by 2035 to meet the demand but could be set to lose 430,000 staff to retirement over the next decade.
Simon Bottery, senior fellow at The King’s Fund, said the report was evidence “of the absolute crisis social care faces when trying to recruit staff, a crisis that has profound consequences for people needing care”.
He added: “A key reason for that is pay, which continues to lag behind other sectors including retail and hospitality, as well as similar roles in the NHS. Our recent analysis found that nearly 400,000 care workers would be better paid to work in most supermarkets."
Read full story
Source: The Independent, 11 October 2022
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NHSE drops tech target

NHS England has revealed it is no longer planning to meet a long-term plan maternity digitisation target, because of a change of approach.
Under the heading of “empowering people”, the 2019 long-term plan promised to extend digital access to maternity records to the whole country by 2023-24. This was in addition to digitising the so-called red book, which is used to track the health of babies and young children.
It followed a recommendation in the 2016 Better Births report, led by former health minister Baroness Julia Cumberlege and commissioned by NHS England. It was intended to reduce bureaucracy and improve safety, as well as provide parents with better information.
However, a paper prepared by chief nursing officer Ruth May for NHSE’s October board meeting said while the organisation “remains committed” to digitising the records, meeting the 2024 deadline would be a challenge due to “varying levels of digital maturity and change capacity across maternity services”.
In response, Royal College of Obstetricians and Gynaecologists president Edward Morris told HSJ: “While we recognise the enormous pressures that maternity services are currently facing, we are disappointed that NHSE is no longer on track to meet the target to digitise maternity records by 2024.
“This programme of digitisation will help realise our ambition for more effective use of data collected during pregnancy, to help identify and prevent the future onset of disease and improve outcomes for women and their babies.
“If digital maternity records are to become part of the wider shift to electronic patient records, it is vital that this information is still accessible to both women and healthcare professionals as an important tool for shared decision making.”
Read full story (paywalled)
Source:  HSJ, 11 October 2022
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Lucy Letby was ‘constant malevolent’ presence on neonatal ward, court hears

A nurse murdered seven babies and attempted to kill 10 others by poisoning them on a hospital neonatal unit where she was a “constant malevolent presence”, a court has heard.
Lucy Letby, 32, fatally injected newborns with insulin, air or milk during night shifts when she knew their parents would not be present, a jury was told.
One of the babies was just 24 hours old when Letby allegedly injected him with air, killing him just 90 minutes after she came on shift. The nurse tried to kill his twin sister the next day, it is alleged.
The court was told that Letby, who was trained to care for the most seriously ill babies, developed an “unusual interest” in the parents of some of her 17 alleged victims and in some cases tracked them on Facebook.
Jurors were told that she was the only “common denominator” that connected the deaths of seven infants and the “catastrophic” collapses of 10 others at the Countess of Chester hospital between June 2015 and June 2016. She allegedly tried to kill some babies more than once – in one case, three times – using various methods.
Nick Johnson KC, prosecuting, told the jury: “We say the collapses and deaths of the 17 children named on the indictment were not normally occurring tragedies. They were all the work, we say, of the woman in the dock who we say was a constant malevolent presence when things took a turn for the worse for these children.”
Read full story
Source: The Guardian, 10 October 2022
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‘Exploited’ foreign doctors worry about risk to UK patients

Doctors recruited from some of the world's poorest countries to work in UK hospitals say they're being exploited - and believe they're so overworked they fear putting patients' health at risk.
A BBC investigation has found evidence that doctors from Nigeria are being recruited by a British healthcare company and expected to work in private hospitals under conditions not allowed in the National Health Service.
The British Medical Association (BMA) has described the situation as "shocking" and says the sector needs to be brought in line with NHS working practices.
Dr Jenny Vaughan of the Doctors Association UK said, "This is a slave-type work with… excess hours, the like of which we thought had been gone 30 years ago. It is not acceptable for patients for patient-safety reasons. It is not acceptable for doctors. "
Read full story
Source: BBC News, 11 October 2022
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Spire Healthcare patients recalled over shoulder op concerns

Spire Healthcare, a private healthcare company, has confirmed it will recall patients amid concerns about a surgeon's operations.
It comes after Walsall Healthcare Trust announced it was recalling 600 NHS patients who underwent shoulder surgery performed by Mr Shah.
Spire said it was committed to promptly responding to concerns and undertaking good governance.
Mr Shah is the third shoulder surgeon since 2019 operating from Spire premises to have had issues.
One private patient, Martin Byrne, said he was in immediate pain after an operation to repair his rotator cuff performed by Mr Shah at Spire, Little Aston, in Sutton Coldfield in August 2018.
He had a further two operations, one on the NHS by Mr Shah and another at Spire, but has since been told nothing more can be done surgically.
"This has broken me as a man," he said. "I can't do the things that I used to do with my children. I can't help out lifting at work.
"I have sat on the bed crying at night from the pain and I feel that Spire have offered me a lot of tea and sympathy, but they have just fobbed me off.
"In my opinion, he has ruined me."
Read full story
Source: BBC News, 11 October 2022
Patient Safety Learning

Digital mental health tools to be regulated

Recent years has seen a large, and rapid, growth in the availability of digital mental health tools. Do an online search for 'NHS Mental Health Apps' and an abundance of options will appear.
These online tools can be helpful for people experiencing mental health problems, however, the Medicines Health and Regulatory products Agency (MHRA) said, they "present regulatory challenges" - such as clarity around whether they are medical devices and, if so, which risk classification they fall under.
"Digital mental health tools offer millions of people vital support and guidance to explore and help manage their mental health issues every day," said Johan Ordish, head of software and artificial intelligence (AI) at the MHRA. He pointed out, however, that there are a number of "regulatory complexities" in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness.
Minister for Mental Health, Dr Caroline Johnson, said: "Digital mental health tools can be incredibly useful to help build resilience and prevent problems worsening, but it’s crucial these are regulated properly."
To address these vital issues MHRA and NICE will explore and produce guidance on regulating digital mental health tools, using £1.8m funding by Wellcome over 3 years.
The project will review key aspects of medical device regulations to produce guidance that will support digital mental health in several significant areas – including:
Determining what qualifies as a medical device. The risk classification the devices would fall under. A review of the current evidence base for the devices. The MHRA explained that to achieve this it will "engage with" and "learn from" those with lived experience, subject experts, and patients, to inform their conclusions. 
Read full story
Source: Medscape UK, 11 October 2022
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Shocking scenes uncovered inside Britain's mental health service crisis

A shocking undercover investigation has laid bare appalling failures in patient care on Britain’s mental health wards.
Reporters from Channel 4’s Dispatches programme spent three months secretly filming at one of the UK’s biggest mental health trusts – Essex Partnership University NHS Foundation Trust. 
The footage reveals horrifying abuses of vulnerable residents on two acute mental health wards. It includes patients being dragged across the floor, pinned down by staff, mocked while they are in distress and humiliated.
On one occasion, a patient who is at high risk of suicide and supposed to be under constant supervision is left unattended and makes an attempt on their own life. Another chaotic scene involves staff trying to locate a crucial bag of specialist cutting devices to save the life of a female patient who got hold of a ligature, after a carer failed to keep watch.
In one distressing example, a young woman being treated for anorexia – who is heard hyperventilating with fear – is dragged across the floor by her arms. When she is later discovered making a suicide attempt, she is pinned down by five carers for 40 minutes. As the woman lies sobbing on the floor, one of the staff members discusses the success of his latest diet. Another carer laughs as she marks the rhythm of the woman’s laboured breathing with her hands.
The damning footage raises fresh concerns about the state of treatment for the most mentally unwell in this country.
While the Essex Trust is just one of 54 across England, mental health professionals and families warn that such failures are widespread.
Former mental health nurse Julie Repper, director of imROC, an organisation that helps improve patients’ experiences in mental health services, describes events in the film as ‘literally abusive’.
"I asked the peer support workers we train about their experiences of the system, and they described seeing repeated ligaturing, people being dragged by their feet and being restrained. It’s ubiquitous".
"These units are supposed to keep people safe, but this film shows they’re not. Everybody has a stake in seeing this improve, because every single one of us may become overwhelmed at some point and find we hit a crisis."
Read full story
Source: MailOnline, 10 October 2022
Patient Safety Learning

Trust orders 'civility training' for senior leaders

An ambulance service rated ‘inadequate’ by the Care Quality Commission has set out a wide-ranging improvement plan, including ‘civility training’ for senior leaders and ensuring board members hear a mix of ‘positive and negative’ stories from patients and staff.
South Central Ambulance Service has been moved into the equivalent of “special measures” by NHS England, in the wake of the Care Quality Commission report in August which criticised “extreme positivity” at the highest levels of the organisation.
This means 3 out of only 10 dedicated ambulance service trusts in England are now in segment four of NHSE’s system oversight framework, the successor to special measures. The other ambulance services in segment four are East of England and South East Coast.
In a damning inspection report published in August, the care watchdog said that leaders were “out of touch” and staff had faced a “dismissive attitude” when they tried to raise concerns.
One staff member told inspectors: “When sexual harassment is reported it seems to be brushed under the carpet and the person is given a second chance. Because of this, a lot of staff feel unsafe, unsupported and vulnerable when coming to work.”
An improvement plan summary published at the start of last month included a large number of priorites and actions, including to “ensure [a] mix of positive and negative patient/staff stories are presented to [trust] board meetings” – an apparent attempt to address CQC concerns that its positive outlook could feel “dismissive of the reality to frontline staff”.
Read full story (paywalled)
Source: HSJ, 11 October 2022
Sam

New NHS genetic testing service ‘could save thousands of children’ in England

Very sick babies and children will be diagnosed and start treatment more quickly thanks to a “revolutionary” new genetic testing service being launched by the NHS.
Doctors will gain vital insights within as little as two days into what illnesses more than 1,000 newborns and infants a year in England have from the rapid analysis of blood tests.
Until now, when doctors suspected a genetic disorder, such tests have sometimes taken weeks as they had to be done in a sequential order to rule out other possible diagnoses, delaying treatment.
NHS England bosses say the service could save the lives of thousands of seriously ill children over time and will usher in “a new era of genomic medicine”.
The clinical scientists, genetic technologists and bioinformaticians will carry out much faster processing of DNA samples, including saliva and other tissue samples as well as blood. They will share their findings with medical teams and patients’ families.
“This global first is an incredible moment for the NHS and will be revolutionary in helping us to rapidly diagnose the illnesses of thousands of seriously ill children and babies, saving countless lives in the years to come,” said Amanda Pritchard, NHS England’s chief executive.
Read full story
Source: The Guardian, 12 October 2022
Further hub reading
Genetic profiling and precision medicine – the future of cancer treatment
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