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

MHRA's response to the Cumberlege report

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to the Independent Medicines and Medical Devices Safety Review.
In its response, the MHRA said: “Today’s publication of the Independent Medicines and Medical Devices Safety Review is of profound importance for the MHRA, since the safety of the public is our first priority."
"We therefore take this report and its findings extremely seriously. Throughout the Review’s work we have listened intently to the many distressing experiences of women and their families. We will now carefully study the findings and recommendations of the Report.
We recognise that patient safety must be continually protected and that many of the major changes recommended by the Review cannot wait. We are therefore making changes without delay to ensure that we listen to patients and involve them in every aspect of our work.
We are already taking steps to strengthen our collaboration with all bodies in the healthcare system and will strive to ensure that, working with these other bodies, the safety changes we advise are embedded without delay in clinical practice.
We wholeheartedly commit to demonstrating to those patients and families who have shared their experiences during the Review, and anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. We are determined to put patients and the public at the heart of everything we do."
Read full statement
Source: GOV.UK, 8 July 2020
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NHS patients in England face longest waits on record for surgery and cancer care

Far fewer people are having surgery or cancer treatment because COVID-19 has disrupted NHS services so dramatically, and those who do are facing the longest waits on record.
NHS figures reveal huge falls in the number of patients who have been going into hospital for a range of vital care in England since the pandemic began in March, prompting fears that their health will have worsened because diseases and conditions went untreated.
Patients have been unable to access a wide range of normal care since non-COVID-19 services were suspended in hospitals in March so the NHS could focus on treating the disease. Many patients were also afraid to go into hospital in case they became infected, which contributed to a fall in treatment volumes.
Tim Gardner, a senior policy fellow at the Health Foundation thinktank, said: “The dramatic falls in people visiting A&E, urgent referrals for suspected cancer and routine hospital procedures during lockdown are all growing evidence that more people are going without the care they need for serious health conditions."
“Early diagnosis and prompt treatment of cancer is crucial to saving lives, and delays in referrals and treatment during the pandemic are likely to mean more people are diagnosed later when their illness is further advanced and harder to treat.”
Read full story
Source: Guardian, 9 July 2020
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If we only ever sanctify the NHS, its harrowing failures will NEVER be cured, says Ian Birrell

Daniel Mason was born half a century ago without hands, with missing toes, a malformed mouth and impaired vision.
From an early age, he and his family had to deal with people asking about his disabilities. The impact on his life has been considerable.
Daniel’s mother Daphne long suspected the cause of his problems was a powerful hormone tablet called Primodos that was given to women to determine whether they were pregnant. But when she raised her concerns with doctors, they were dismissed.
Now, at last, Daphne has been vindicated with official confirmation this week that her fears were right, in the landmark review by Baroness Cumberlege into three separate health scandals that has exposed a litany of shameful failings by the NHS, regulatory authorities and private hospitals.
This damning report shows again the danger of placing a public service on a pedestal, with politicians happy to spout platitudes but scared to tackle systemic problems or confront the medical establishment.
But how many more of these inquiries must be held? How many more disturbing reports and reviews must be written?
How many more times must we listen to ministerial apologies to betrayed patients? How much more must we hear of ‘lessons being learned’ when clearly they are largely ignored?
Read full story
Source: Mail Online, 9 July 2020
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Coronavirus: Dementia patients 'deteriorating' without family visits

Relatives of care home residents with dementia should be treated as key workers, leading charities say.
In a letter to the health secretary, they write that the care given by family members is "essential" to residents' mental and physical health.
They argue the current limits on visitors have had "damaging consequences" and they want visits to resume safely, with relatives given the same access to care homes and coronavirus testing as staff.
Signed by the bosses of leading charities including Dementia UK and the Alzheimer's Society, the letter calls on the government to "urgently" address what it calls the "hidden catastrophe" happening in care homes.
The charities say that this "enforced separation" has caused a "deterioration" in residents' mental and physical health, particularly for those living with dementia - who make up more than 70% of the population of care homes.
Read full story
Source: BBC News, 9 July 2020
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Government delay could see people miss out on vaccines

Pharmacies are warning people are at risk of not getting the flu jab unless an urgent decision is made over the winter vaccination programme.
The Company Chemists’ Association, which represents large pharmacy groups, told HSJ the government and NHS England need to “urgently” clarify how many people it wants vaccinated for flu this year, as well as making changes to regulations.
An expanded and successful winter vaccine programme is seen as key to avoiding potentially catastrophic demand for hospital beds, with flu demand coinciding with covid-19 surges.
Malcolm Harrison, chief executive, said: “We need decisions made now. We have an ongoing dialogue with NHS England but they seem to be waiting on secretary of state’s decision on which groups need vaccinating. That is something [the health secretary, Matt Hancock] needs to make a decision about very, very soon.”
Read full story (paywalled)
Source: HSJ, 10 July 2020
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Non-invasive ventilation deaths fell for first time in 2019, audit finds

Inpatient mortality among people receiving non-invasive ventilation (NIV) has decreased for the first time since 2010, falling from 34% in 2013 to 26% in 2019, figures released by the British Thoracic Society show.
The annual National Adult Non-Invasive Ventilation audit, which began in 2010, reported “substantial improvements in processes of care and patient outcomes” in 2019 when compared with previous years.
“Some improvement in overall mortality may be attributed to improved patient selection,” it said. “Mortality outcomes were lower for each diagnostic category, and most notably for patients with COPD [chronic obstructive pulmonary disease] and obesity-related respiratory failure.”
Read full story (paywalled)
Source: BMJ, 10 July 2020
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Warning of serious brain disorders in people with mild coronavirus symptoms

Doctors may be missing signs of serious and potentially fatal brain disorders triggered by coronavirus, as they emerge in mildly affected or recovering patients, scientists have warned.
Neurologists are on Wednesday publishing details of more than 40 UK COVID-19 patients whose complications ranged from brain inflammation and delirium to nerve damage and stroke. In some cases, the neurological problem was the patient’s first and main symptom.
The cases, published in the journal Brain, revealed a rise in a life-threatening condition called acute disseminated encephalomyelitis (Adem), as the first wave of infections swept through Britain. At UCL’s Institute of Neurology, Adem cases rose from one a month before the pandemic to two or three per week in April and May. One woman, who was 59, died of the complication.
“We’re seeing things in the way Covid-19 affects the brain that we haven’t seen before with other viruses,” said Michael Zandi, a senior author on the study and a consultant at the institute and University College London Hospitals NHS foundation trust.
“What we’ve seen with some of these Adem patients, and in other patients, is you can have severe neurology, you can be quite sick, but actually have trivial lung disease,” he added.
Read full story
Source: The Guardian, 8 July 2020
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Coronavirus sufferers still have weird symptoms 100 days after surviving bug

Coronavirus patients have continued to suffer from fatigue, breathlessness and forgetfulness more than 100 days after contracting the bug. Many COVID-19 survivors have found that they are not back to normal months after they tested positive.
Louise Nicholls, from Litherland in Liverpool, is one of those people who found themselves suffering from curious symptoms long after she should have been back to normal.
She was told she had coronavirus by her doctor on 1 April having gone in search of medical help after suffering from a number of respiratory symptoms. "I was trying to do my workouts and I was getting really short of breath," Louise said.
"I couldn't put my finger on what was going on but it got worse every day. My chest started getting tighter and my lungs were burning. I didn't have a cough or a fever but I had shortness of breath and I was waking up with night sweats."
Louise said her symptoms were dismissed as anxiety by those around her at first, but when her symptoms got worse she phoned the doctor who said it sounded like coronavirus.
Louise said: "My doctor said it sounds like covid. She said 'you're young and fit, you'll be over it in a few weeks' and sent me on my way."
Louise's breathing continued to get worse and she was given a steroid inhaler, which she is still taking today. Although Louise feels much better than she did at one time, she is still struggling with her breathing today and is continuing to use her inhaler.
She said: "I feel much better than I was but I can't push myself too much... My chest feels tight if I don't take my inhaler every day."
Read full story
Source: Mirror, 12 July 2020
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Man plans to sue NHS after cancer surgery delayed due to coronavirus

A former senior NHS official plans to sue the organisation after he had to pay a private hospital £20,000 for potentially life-saving cancer surgery because NHS care was suspended due to COVID-19.
Rob McMahon, 68, decided to seek private treatment after Worcestershire Acute Hospitals NHS trust told him that he would have to wait much longer than usual for a biopsy. He was diagnosed with prostate cancer after an MRI scan on 19 March, four days before the lockdown began.
McMahon was due to see a consultant urologist on 27 March but that was changed to a telephone consultation and then did not take place for almost two weeks.
“At that appointment, the consultant said: ‘Don’t worry, these things are slow-growing. You’ll have a biopsy but not for two or three months.’ I thought, ‘that’s a long time’, so decided to see another consultant privately for a second opinion.”
A PET-CT scan confirmed that he had a large tumour on both lobes of the prostate and a biopsy showed the cancer was at risk of breaking out of the prostate capsule and spreading into his body. He then paid to undergo a radical prostatectomy at a private Spire hospital.
“This is care that I should have had on the NHS, not something that I should have had to pay for myself. I had an aggressive cancer. I needed urgent treatment – there was no time to waste,”, he said. “With the pandemic, he added, “it was almost like a veil came down over the NHS. He worked for the NHS for 17 years as a manager in hospitals in London, Birmingham and Redditch, Worcestershire, and was the chief executive of an NHS primary care trust in Leicester.”
Mary Smith of Novum Law, McMahon’s solicitors, said: “Unfortunately, Rob’s story is one of many we are hearing about from cancer patients who have been seriously affected by the disruption to oncology services as a result of COVID-19."
Read full story
Source: The Guardian, 11 July 2020
 
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COVID-19: Many trusts have not done risk assessments for ethnic minority staff

Some NHS trusts in England are yet to complete /cOVID-19 risk assessments for their staff from ethnic minority groups more than two months after the NHS first told them to do so, an investigation by The BMJ has found.
On 29 April NHS England’s chief executive, Simon Stevens, wrote to all NHS leaders telling them to carry out risk assessments and make “appropriate arrangements” to protect ethnic minority staff, amid growing evidence that they were at greater risk of contracting and dying from COVID-19.
However, The BMJ asked England’s 140 acute care trusts for details of risk assessments they had carried out and what subsequent actions they had put in place. Seventy trusts responded. Of these, 27 (39%) said that assessments were yet to be completed for all ethnic minority staff, and 43 (61%) indicated that assessments had been completed. But the other 70 trusts were unable to provide a response within the 20 day deadline, citing “unprecedented challenges” posed by the COVID-19 pandemic, so it is not known what stage they are at in risk assessing staff.
Commenting on The BMJ’s findings, Chaand Nagpaul, the BMA’s chair of council, said, “Clearly, we know that a significant number of doctors have not been risk assessed. It is a shame that it has taken so long, because the risk assessments and mitigations would have been most useful and impactful during the peak of the virus.”
Doctors’ leaders have suggested that systemic race inequalities in the workplace may have exacerbated delays in risk assessing staff. Nagpaul said, “The BMA survey found that doctors from a BAME [black, Asian, and minority ethnic] background felt under more pressure to see patients without adequate protection. So it does beg the question of whether there’s also been this added factor of BAME healthcare staff feeling unable to demand their right to being assessed and protected."
“This is something the NHS needs to tackle. This is an issue that predates covid. It’s vital that we have an NHS where anyone is able to voice their concerns. No one should have to suffer or have fear in silence.”
Read full story
Source: The BMJ, 10 July 2020
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NHS data reveals 'huge variation' in COVID-19 death rates across England

A wide disparity in coronavirus mortality rates has emerged in English hospitals, with data seen by the Guardian showing that one hospital trust in south-west England had a death rate from the disease of 80% while in one London trust it was just 12.5%.
The figures, which NHS England has compiled but never published, show the age-standardised mortality rates that all of the country’s 135 acute hospital trusts have recorded during the pandemic. Doctors regard age as the single biggest predictor or risk factor for dying from COVID-19.
They cover the period from the start of the coronavirus crisis in March, through its peak in late March and April, up until 15 May, by which time 42,850 (85%) of the 50,219 deaths so far in all settings had occurred in England and Wales.
It is the first such data to emerge about how many people have lived or died in each trust after being treated there because they had been left critically ill by the disease. They are based on patients who were treated in an intensive care or high-dependency unit or on a ward.
Senior doctors said the dramatic gap in death rates of 67.5 percentage points between the trusts with the highest and lowest rates was notable and may mean that some hospitals needed to learn lessons from others.
Read full story
Source: Guardian, 14 June 2020
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Trust failed to complete 21 instructions from safety review

Only two out of 23 recommendations from a royal college review into a trust’s troubled maternity services can be shown to be fully implemented, a new investigation has revealed.
A learning and review committee, set up by East Kent Hospitals University Foundation Trust, found that 11 more of the recommendations from a 2016 review by the Royal College of Obstetricians and Gynaecologists (RCOG) were “partially” implemented.
But it said there was either no evidence the remaining 10 had been delivered, or there was evidence they were not implemented.
The original RCOG review looked at a number of cases where babies had died as well as broader issues within the maternity service at the trust.
The committee was set up after an inquest into the death of Harry Richford, who died a week after his birth in 2017 at the trust’s Queen Elizabeth, the Queen Mother, Hospital in Thanet. Many of the issues which came to light at his inquest echoed those from the RCOG report.
Committee chair Des Holden, medical director of Kent Surrey Sussex Academic Health Science Network, highlighted the difficulties in tracking evidence and action plans during a time when the trust had significant changes in leadership. But he said the committee felt cases where evidence could not be found or the standard of evidence gave concern, the recommendations could not be said to be met.
Derek Richford, Harry’s grandfather, said on behalf of the family: “We are saddened and shocked to find that over four years after the RCOG found fundamental systemic failings and made 23 recommendations, only two have been completed. It is not good enough for them to now say ‘leadership has changed’. The main board must take responsibility and be held to account.”
Read full story (paywalled)
Source: HSJ, 13 July 2020
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Coroner orders closer working between five trusts after prisoner’s death

Five NHS trusts in the South West have been ordered to make immediate improvements after the death of a 20-year-old prisoner who needed healthcare.
Lewis Francis was arrested in Wells, Somerset, in 2017 after stabbing his mother while “acutely psychotic” and taken into custody. Although his condition mandated a transfer to a medium secure mental health hospital, there was “no mechanism” in place to move Mr Francis and he was taken to prison, where he died by suicide two days later, according to a coroner.
Contributory factors to his death included “insufficient collaboration, communication and ownership between and within organisations… together with insufficient knowledge of… the Mental Health Act,” according to Nicholas Rheinberg, the assistant coroner for Exeter and Greater Devon.
In a Prevention of Future Deaths report, Mr Rheinberg said a memorandum of understanding was in place for the transfer of “mentally ill prisoners direct from police custody” in the West Midlands, and he called on the South West Provider Collaborative to agree a similar deal with “relevant organisations and agencies”.
Read full story (paywalled)
Source: HSJ, 14 July 2020
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‘No one ever tried to contact me’: Former police chief’s anger over ‘do not resuscitate’ order for his sister

Across the country there have been reports of “do not resuscitate” (DNR) orders being imposed on patients with no consultation, as is their legal right, or after a few minutes on the phone as part of a blanket process.
Laurence Carr, a former detective chief superintendent for Merseyside Police, is still angry over the actions of doctors at Warrington Hospital who imposed an unlawful “do not resuscitate” order on his sister, Maria, aged 64.
She has mental health problems and lacks the capacity to be consulted or make decisions and has been living in a care home for 20 years. As her main relative, Mr Carr found out about the notice on her records only when she was discharged to a different hospital a week later.
Maria had been admitted for a urinary tract infection at the end of March. Although she has diabetes and an infection on her leg her condition was not life threatening.
Mr Carr said: “My sister has no capacity to effectively be consulted due to her mental illness and would not understand if they did try to explain, so I was furious that I had not been consulted."
He later learnt that the reason given by the hospital for imposing the DNR was "multiple comorbitidies".
In a statement, Warrington and Halton Teaching Hospitals Foundation Trust said it was fully aware of the law, which was reflected in its policies and regular training.
It said: “We did not follow our own policy in this case and have the requisite discussions with the family. The template form which was completed in this case indicates that discussion with the family was ‘awaiting’. Regretfully due to human error this did not occur."
Mr Carr and his sister are not alone. National charity Turning Point said it had learnt of 19 inappropriate DNARs from families, while Learning Disability England said almost one-fifth of its members had reported DNARs placed in people’s medical records without consultation during March and April.
Read full story
Source: The Independent, 14 July 2020
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Coronavirus: People told to phone ahead before going to A&E in Wales

People with non-life threatening illnesses will be told to call before going to Wales' biggest A&E department. Patients will be assessed remotely and given a time slot for the University Hospital of Wales in Cardiff if needed.
Hospital bosses feel returning to over-crowded waiting rooms would provide an "unacceptable" risk to patients due to coronavirus.
The system is set to start at the end of July, but will not apply to people with serious illnesses or injuries.
Details are still being discussed by Cardiff and Vale health board, but patients with less serious illnesses or injuries will be told to phone ahead, most likely on the 24-hour number used to contact the local GP out-of-hours service. They will be assessed by a doctor or a nurse and, depending on the severity of the condition, will either be given a time window to go to A&E or be directed to other services.
This system was introduced in Denmark several years ago.
"This is all about being safe and ensuring that emergency medicine and emergency care is safe and not about putting barriers in place to those more vulnerable people," says the department's lead-doctor Dr Katja Empson.
"What we really think is that by using this system, we'll be able to focus our attention on those vulnerable groups when they do present."
If successful, the system could become a long-term answer to reducing pressures on emergency medicine, she added.
Read full story
Source: BBC News, 14 July 2020
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Women are duped into believing the most common mesh operation is safe, campaigners say

The NHS have duped thousands of women into believing the most common incontinence mesh operation is safe, by not adding loss of sex life into its risk figures, campaigners say.
The move keeps figures low so surgeons can reassure women that it is a safe day case operation.
The discovery is buried in a report from five years ago, and when questioned on it, the MHRA, tasked with making sure implants are safe for patients, passed the buck and blamed the report authors.
The revelation comes after a debate in Westminster, where health minister Jackie Doyle Price said there was not enough evidence to suspend the plastic implants and quoted a risk of 1-3%.
However, those figures were blown out of the water just weeks before the debate in a landmark study using the NHS’s own hospital re-admission figures which show TVT mesh tape risk is at least 10%.
Campaigners say even that is not a reflection of the true scale of the mesh disaster because it does not take into account women going to doctors for pain medication or those suffering in silence.
Read full story
Source: Cambs Times, 31 October 201t
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