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FDA panel backs first over-the-counter birth control pill in US

The first non-prescription birth control pill in the US is on the way to approval, after a thumbs-up from an advisory committee of drug regulators.

The Food and Drug Administration (FDA) panel's unanimous vote is not binding, but means the agency is likely to formally approve the drug this summer.

Opill has been available, but only by prescription, for the past 50 years.

The push for over-the-counter access in the US comes amid Republican-led efforts to restrict access to abortion and contraception at the national and state level.

Advisors on the panel said they were mostly confident women of all ages would use the drug as appropriate without first consulting a healthcare provider.

"In the balance between benefit and risk, we'd have a hard time justifying not taking this action," said chairwoman Maria Coyle, an Ohio State University pharmacist.

"The drug is incredibly effective, and I think it will be effective in the over-the-counter realm just as it is in the prescription realm."

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Source: BBC News, 10 May 2023

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Figures show maternal death rate race disparity

Figures showing the risk of maternal death being almost four times higher among women from black ethnic minority backgrounds compared with white women in the UK have been published.

The figures, which relate to 2019 - 2021, have been released by MBRRACE-UK, a collaboration involving the University of Leicester.

The MBRRACE-UK collaboration (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries), led from Oxford Population Health's National Perinatal Epidemiology Unit, looked at data on women who died during, or up to six weeks after, pregnancy between 2019 and 2021 in the UK.

The report showed the risk of maternal death in 2019 - 2021 was almost four times higher among women from black ethnic minority backgrounds compared with white women.

Marian Knight, professor of Maternal and Child Population Health at Oxford Population Health and maternal reporting lead, said: "Persistent disparities in maternal health remain.

"It is critical that we are working towards more inclusive care where women are listened to, their voices are heard, and we are acting upon what they are telling us."

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Source: BBC News, 11 May 2023

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AI can predict pancreatic cancer three years before it occurs, major Harvard study finds

A breakthrough AI model can determine a person's risk of developing pancreatic cancer with staggering accuracy, research suggests.

Using medical records and information from previous scans, the AI was able to flag patients at a high risk of developing pancreatic cancer within the next three years with great accuracy.

There are currently no full-proof scans for pancreatic cancer, with doctors using a combination of CT scans, MRIs and other invasive procedures to diagnose it. This keeps many doctors away from recommending these screenings.

Over time, they also hope these AI models will help them develop a reliable way to screen for pancreatic cancer — which already exists for other types of the diseases.

"One of the most important decisions clinicians face day to day is who is at high risk for a disease, and who would benefit from further testing, which can also mean more invasive and more expensive procedures that carry their own risks," Dr Chris Sander, a biologist at Harvard who contributed to the study, said. 

"An AI tool that can zero in on those at highest risk for pancreatic cancer who stand to benefit most from further tests could go a long way toward improving clinical decision-making."

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Source: Mail Online, 9 May 2023

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Online UK pharmacies prescribing weight loss jabs to people with healthy BMI

Online pharmacies operating in the UK are approving and dispatching prescriptions of controversial slimming jabs for people of a healthy weight, a Guardian investigation has found.

Some pharmacies appear to be issuing prescriptions of such medications to people who lie about their body mass index (BMI) on an online form. In one case a reporter was issued a prescription after accurately saying their BMI was about 20. A healthy BMI lies between 18.5 and 24.9.

The findings have raised alarm among eating disorder charities, which have warned that weight-loss medications should only be sold under the strictest conditions. Their concern has prompted calls for online pharmacies to employ stronger health checks and screening for eating disorders.

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Source: The Guardian, 10 May 2023

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Children with type 2 diabetes to be given sensors to replace finger-prick testing

Hundreds of children who manage their type 2 diabetes by regularly pricking their finger can now monitor their glucose levels using automated sensors, the government’s expert health advisers have announced.

Doctors and nurses in England, Wales and Northern Ireland have been advised they can now give glucose monitoring devices to children with type 2 diabetes who currently use the more intrusive finger-prick testing methods, the National Institute for Health and Care Excellence (NICE) said on Thursday.

The health minister Helen Whately said that offering children the devices would relieve a burden and “empower them to manage their condition more easily”.

She said: “Type 2 diabetes is increasingly being diagnosed in children, many of whom face the constant stress of needing to monitor their blood glucose levels by finger-prick testing – often multiple times a day – just to stay healthy and avoid complications.”

The NICE committee that reached the decision heard that children found finger pricking to check their glucose levels several times a day “burdensome”, “tiring” and “stressful”.

The devices, which give a continuous stream of real-time information on a smartphone, have already been recommended for children with type 1 diabetes, a less aggressive form of the disease.

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Source: The Guardian, 11 May 2023

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Pledge to reduce NHS backlog has been broken, Steve Barclay admits

A key government pledge to reduce the size of the NHS’s record-breaking care backlog has been broken, the health secretary has admitted.

Steve Barclay slipped out the news in a Commons statement on Tuesday about a totally unrelated area of NHS policy – his new plan to improve access to GP care.

He disclosed to MPs that the NHS in England had missed its target to ensure that all patients who had been waiting 18 months for an operation in hospital would be treated by April.

It is thought that about 10,000 people who had been waiting for at least 78 weeks were still languishing on the 7.2 million-strong waiting list at the end of April.

The failure to eradicate 18-month waits for care is embarrassing for Rishi Sunak, who made “cut waiting lists” one of his five key pledges and insisted as recently as January that the promise, which NHS England and the then health secretary Sajid Javid first made in the elective surgery recovery plan last year, would be honoured.

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Source: The Guardian, 9 May 2023

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Seriously ill children put at risk by firm’s failure to deliver NHS medication

Children with serious health conditions are getting sicker as a result of persistent failings by Sciensus, a private company paid millions by the NHS to deliver essential medication, the Guardian can reveal.

Parents of sick children say they are repeatedly let down by botched, delayed or missed deliveries, while NHS paediatric clinicians warn some are suffering avoidable harm as a result.

Sciensus failed to send injections to Autumn Powell, an eight-year-old girl with Crohn’s disease, four times this year, according to her mother, Dallas Powell. As a result, she has suffered stomach cramping, pain and fatigue, and been off school sick.

“It makes me mad, frustrated, but mostly it’s heartbreaking seeing my child suffering – and feeling helpless,” Powell said. “I am not one to go and complain publicly, but this is serious.”

In a complaint to the Care Quality Commission (CQC), the care regulator, three NHS paediatric clinicians working at two of the UK’s largest children’s hospitals have raised multiple concerns about Sciensus.

Medicines ordered by the NHS to be sent urgently to sick children were delayed or never arrived, they said. Parents of those with serious health conditions also experienced difficulties with the company’s app. In some cases Sciensus did not respond to emails and calls about children’s missing medicines.

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Source: The Guardian, 9 May 2023

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Staff shortages force pharmacies to close for 100,000 hours in a year amid plans to give them more work

Staff shortages forced pharmacies to shut for 100,000 hours in a year, new figures show, just as the government has unveiled plans to shift more GP work their way.

The data, shared exclusively with The Independent by the organisation which represents pharmacies in England, also showed that almost 1,000 establishments closed for good between October 2016 and November 2022.

The Pharmaceutical Services Negotiating Committee (PSNC) figures revealed that pharmacies in the most deprived areas were more likely to shut permanently due to lack of staff, with areas such as Birmingham and Manchester among the worst affected.

The figures come as the government announced plans on Tuesday to allow pharmacists to prescribe medicines for conditions including earache, sore throats and urinary tract infections without GP involvement.

However, experts have said the plans are unlikely to significantly reduce pressure on GP practices as prescriptions for these conditions make up just 3 per cent of all appointments.

And the King’s Fund health think tank warned of the potential for a postcode lottery – saying some pharmacies will not be able to offer the services because they may not have access to diagnostic tools, or sufficient staff and consultation rooms.

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Source: The Independent, 10 May 2023

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USA: Amid hospital 'chaos,' stick to standards to improve quality

Every time a mistake is made in a healthcare setting, there can be serious repercussions. Patients may suffer lifetime injuries or even pay the ultimate price for someone else's mistake. Hospitals may wind up paying the price literally — financially and legally — and suffer costly public reputation troubles in the aftermath. 

Increased patient loads combined with the workforce shortage and often decreasing financial resources have created "chaos" in hospitals, said Doug Salvador MD, chief quality officer at Baystate Health in Springfield, Mass. 

Safety watchdog organizations, including The Joint Commission and The Leapfrog Group, have reported the result of that chaos: soaring cases of preventable medical errors. 

The solution, he and several other sources who spoke with Becker's said, is to create standard operating procedures in every department, at every step of the patient journey. These SOPs are more than lists of guidelines; they require strict adherence and limited room for error thanks to built-in cross-check points. And, when instituted properly, they highlight system flaws in real time by creating what Dr. Salvador called "situational awareness." 

Situational awareness, he added, keeps front-line healthcare professionals on top of their safety game. 

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Source: Becker's Healthcare, 9 May 2023

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AI poses existential threat and risk to health of millions, experts warn

AI could harm the health of millions and pose an existential threat to humanity, doctors and public health experts have said as they called for a halt to the development of artificial general intelligence until it is regulated.

Artificial intelligence has the potential to revolutionise healthcare by improving diagnosis of diseases, finding better ways to treat patients and extending care to more people.

But the development of artificial intelligence also has the potential to produce negative health impacts, according to health professionals from the UK, US, Australia, Costa Rica and Malaysia writing in the journal BMJ Global Health.

The risks associated with medicine and healthcare “include the potential for AI errors to cause patient harm, issues with data privacy and security and the use of AI in ways that will worsen social and health inequalities”, they said.

One example of harm, they said, was the use of an AI-driven pulse oximeter that overestimated blood oxygen levels in patients with darker skin, resulting in the undertreatment of their hypoxia.

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Source: The Guardian, 10 May 2023

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Lip fillers: Call for tighter regulation after botched treatments

Lip fillers have grown increasingly popular but the industry is "like the wild west", experts warn, with many patients left in pain and embarrassed by their appearance.

As Harriet Green left a salon after getting an injection to add volume to her lips, she was reassured the excess swelling would go down. But three months later her lips were still so bloated she could not close her mouth properly.

The 22-year-old from Acle in Norfolk needed three corrective procedures - costing a total of more than £700 - to get them back to normal.

Dr Saba Raja, a GP who runs her own aesthetics clinic in Norwich, says she is increasingly having to correct treatments which have gone wrong, describing the experience as "really distressing".

"Every month I'm getting enquires from young girls who have gone to a non-medical practitioner for lip or tear trough fillers under the eye and had complications.

"They often try to contact the practitioner but due to lack of training they are unable to deal with the complications. It is becoming more and more of a problem."

Dr Raja describes the industry as "like the wild west", with people injecting patients "out of the back of their cars" and in kitchens.

"Anti-wrinkle injections (Botox) are prescription-only but the injector can be anybody who has been on a day course. Dermal filler (for the lips and face) is not even a prescription-only medication, you can buy it off any website," she says.

"A lot of non-medical practitioners are buying cheap filler online, with no idea where it has come from. We really need strict regulations and minimum training standards."

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Source: BBC News, 9 May 2023

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Patients asked to return Emerade adrenaline pens for replacement

Patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should immediately contact their GP to obtain a prescription for, and be supplied with two auto-injectors of a different brand. Pharmacists and pharmacy teams can also help with obtaining new prescriptions and dispensing of new pens. Patients or carers should then return all Emerade 300 and 500 micrograms auto-injectors to their local pharmacy.

Patients should only return their Emerade pens when they have received a replacement from their pharmacy which will be an alternative brand - either EpiPen or Jext. They should ensure they know how to use the replacement pen, as each brand of pen works differently. Patients should ask their doctor, pharmacist, or nurse for help with this. Instructions are included inside the pack, along with details of the manufacturer’s website that also provides information, including videos, on how to use a new EpiPen or Jext adrenaline pen.

This precautionary recall is because some 300 microgram and 500 microgram Emerade auto-injector pens may rarely fail to activate if they are dropped, meaning a dose of adrenaline would not be delivered. Premature activation has also been detected in some of the 300 microgram and 500 microgram pens after they have been dropped, meaning that a dose of adrenaline is delivered too early.

The activation failure and premature activation was detected during a design assessment conducted by the manufacturer and therefore means there is a potential for some 300 microgram and 500 microgram Emerade pens to fail during use after having been dropped.

Read MHRA Press Release. 9 May 2023

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School-leavers could join NHS via apprenticeships in plan to fix staff shortages

School-leavers could receive on-the-job training as part of an attempt to help address NHS workforce shortages, under plans to allow tens of thousands of doctors and nurses to join the health service via apprenticeships.

Up to 1 in 10 doctors and a third of nurses could be trained through this vocational path in the coming years under the NHS workforce plan. The NHS’s doctor apprenticeship scheme is due to start in September, where medics in training will be able to earn money while they study.

The concept was first introduced as an alternative route into medicine circumventing the standard undergraduate or graduate university programmes.

Dr Latifa Patel, workforce lead for the British Medical Association, said innovative approaches to education and training are welcome but there were huge question marks over how far medical apprenticeships can solve the recruitment crisis.

Patel said: “We don’t know if medical schools and employing organisations are going to be able to produce medical degree programmes to meet individual apprenticeship needs while also meeting the same high standards of training experienced by traditional medical students.

“We have little evidence on whether the apprentice model will work at scale, and whether employers will want to take the investment risk with no guarantee of a return."

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Source: The Guardian, 10 May 2023

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Regulator clears trust to bring back junior doctors

Up to 10 junior doctor posts will be reinstated at a small district general hospital after regulators agreed it had improved its learning environment.

In 2021, Health Education England removed 10 doctors from Weston Hospital over concerns they were being left without adequate supervision on understaffed wards. 

The unusual move prompted University Hospitals Bristol and Weston Foundation Trust to launch a “quality improvement approach” to improve its learner and clinical supervision environment.

The regulator said the trust had made significant improvements that included:

  • Better staff engagement with the trust leadership at all levels.
  • Better clinical supervision, particularly around shift handovers and senior oversight of clinical decisions.
  • Better learner experience in new training settings in rheumatology and intensive care medicine.

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Source: HSJ, 10 May 2023

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‘Little evidence’ whether or not most antidepressants work for chronic pain

Antidepressants commonly used to treat chronic pain lack evidence as to whether or not they work, researchers have said, declaring the situation a global public health concern.

Chronic pain, typically defined as pain lasting three months or more, is a widespread problem affecting up to one in three people, with conditions ranging from osteoarthritis to fibromyalgia.

While exercise is often recommended, this is difficult for some patients, while there are concerns that opioids and other painkillers such as aspirin and paracetamol could do more harm than good.

Increasing numbers of patients are prescribed antidepressants to treat their pain, with hundreds of thousands in the UK estimated to be taking amitriptyline. Antidepressants affect chemicals known as neurotransmitters, which is how they are thought to relieve pain.

But a new Cochrane review, led by Prof Tamar Pincus, professor in health psychology at the University of Southampton, has revealed there is little evidence whether or not amitriptyline and many other common antidepressants work when it comes to tackling chronic pain.

“The fact that we don’t find evidence whether it works or not, is not the same as finding evidence that it doesn’t work,” she said. “We don’t know. The studies simply are not good enough.”

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Source: The Guardian, 10 May 2023

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Poor diabetes care may be behind 7,000 excess deaths

Delayed health checks among people with diabetes may have contributed to 7,000 more deaths than usual in England last year, a charity report suggests.

The routine checks help cut the risk of serious complications like amputations and heart attacks.

Diabetes UK says too many people are still being "left to go it alone" when managing their challenging condition.

There are more than five million people in the UK living with diabetes, but around 1.9 million missed out on routine vital checks in 2021-22, Diabetes UK says.

Disruption to care during the pandemic is likely to be a factor in the current backlog, which may be leading to higher numbers of deaths than usual in people with diabetes, it says.

Between January and March 2023, for example, there were 1,461 excess deaths involving diabetes - three times higher than during the same period last year.

"Urgent action is needed to reverse this trend and support everyone living with diabetes to live well with the condition," the report says.

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Source: BBC News, 10 May 2023

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Update on LFPSE implementation deadline

In an email to staff today (9 May 2023) NHS England (NHSE) have confirmed that to meet the deadline for implementing the new Learn From Patient Safety Events (LFPSE) service, Trusts will only need to ensure this is underway by the 30 September 2023, rather than fully implemented.

LFPSE is a new central national service for recording and analysing patient safety events that occur in healthcare. Some NHS organisations are now using this system, instead of the National Reporting and Learning System (NRLS), and all organisations will be expected to transition to this.

The original date for Trusts to implement LFPSE was the 31 March 2023. However, in response to concerns about the achievability of this deadline, on the 18 October NHSE announced an optional six-month extension, meaning that Trusts needed to deploy the new system by the 30 September 2023.

Today’s email to NHS staff noted that some Trusts “are still anticipating challenges with the time scales”. Responding to this, NHSE clarified that provided the LFPSE transition within organisations Local Risk Management Systems was underway by the end of September, and that application of the guidance to configure formals and fields was being actively worked on, this milestone should be considered as having been met.

Commenting on this Helen Hughes, Chief Executive of charity Patient Safety Learning, said:

“This is a welcome announcement by NHS England, reducing the immediate pressure on staff who had raised serious concerns on the ability to have LFPSE configured and ready to submit events by the 30 September deadline. This flexibility will ensure that the new LFPSE service has a stronger chance of successful transition and to enable patient safety improvement”.

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New target for huge NHS App expansion in general practice

The vast majority of GP practices should allow patients to manage their care through the NHS App in less than a year, according to the primary care recovery plan published by government and NHS England today.  

The plan says patients at more than 90% of practices should be able to use the app to see their records, book appointments and order repeat prescriptions by March 2024. Currently, only around 20% of practices offer this, and data revealed recently by HSJ suggested use of the app is flatlining.

The plan says: “We want the public to have access to health information they can trust, find local services, and use the NHS App where this is their preference to see their medical records, order repeat prescriptions, manage routine appointments with their practice or local hospital and see messages from their practice.

“The NHS App ambitions are already a reality for people registered with around 20% of practices, so this plan focuses on how to increase that to over 90% by March 2024.”

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Source: HSJ, 9 May 2023

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What the NHS is learning from Brazil

Knocking on doors to check on people's health and catch problems before they escalate is common practice across Brazil. But could that approach work in the UK?

Comfort and Nahima are two out of four door-knockers on round Churchill Gardens, a council estate in the Pimlico neighbourhood of London, visiting residents as part of a proactive community healthcare pilot.

They can help with anything from housing issues which impact health, such as overcrowding, or pick up the early signs of diabetes by chatting informally to residents about their lifestyle.

These community health workers are partly funded by the local authority and partly by the NHS so they can co-ordinate between the local GP surgery and other social services.

Local GP Dr Connie Junghans-Minton says the proactive approach had led to fewer requests for appointments

The National Institute for Health Research helped crunch the data from the pilot. Households which had been visited regularly were 47% more likely to have received immunisations and 82% more likely to have taken up cancer screening, compared to other areas.

The idea to import this model to the UK came from Dr Matthew Harris, a public health expert at Imperial College London who worked as a GP in Brazil for four years. There, community health workers have been credited with achieving a drop of 34% in cardiovascular deaths.

"In Brazil they have scaled this role to such degree that they have 270,000 community health workers across the whole country, each of which looks after 150 households, visiting them at least once a month," Dr Harris said.

"They've seen extraordinary outcomes in terms of population health in the last two or three decades. We think we've got a lot to learn from that."

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Source: BBC News, 9 May 2023

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Barclay refusing to approve diagnostic centres that cannot be opened this year

Steve Barclay has refused to approve about 30 proposed community diagnostic centres (CDCs) – designed to speed up cancer treatment – unless they can be delivered in 2023, HSJ has learned.

Mr Barclay’s stance means the CDCs which were due to open in 2024, and which officials say cannot be brought forward, have been left in limbo. NHS England and local systems are now exploring workarounds, such as temporarily using mobile imaging units while the CDCs are established in attempt to win Mr Barclay’s backing.

Cancer Research UK director of evidence and implementation Naser Turabi said: “Community diagnostic centres can help the NHS diagnose cancers more quickly, but they require capital investment and funding for staff if they are to meet rising demand.

“Restricting the promised expansion of these centres will only lead to longer waits and worse outcomes for cancer patients in England.”

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Source: HSJ, 9 May 2023

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Doctor warns poor care at root of outcry over medical test leaving women in agony

A leading consultant has warned that poor care is at the root of a growing outcry over an invasive medical test that has left women in agony.

Dr Helgi Johannsson, vice-president of the Royal College of Anaesthetists, has spoken out about the hysteroscopy after the Sunday Mail revealed the suffering of a series of female patients.

His intervention comes amid a growing backlash around the procedure used to investigate and treat problems in the womb, with more than 3000 women now reporting being left with post-traumatic stress and excruciating pain.

The test involves a long scope being inserted into the womb, often without anaesthetic, leaving one in three in pain.

Dr Johannsson, a consultant anaesthetist at Charing Cross Hospital in London, said: “It sounds like a lot of this is poor care and badly handled, and emotionally badly handled, and (they) didn’t stop when they were supposed to.

“Stories of being held down to finish the procedure are just awful. It’s important that we make the OH as good as we can possibly make it, including some sort of inhalation sedation, but having the ability to say stop when you need to is so important and a measure of good care.”

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Source: Daily Record, 7 May 2023

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Patients getting sicker as they face long waits for NHS care, says top GP

Patients are developing cancers and enduring so much pain that they cannot climb stairs because of the 7.2 million-strong waiting list for NHS scans and treatment, Britain’s top GP has said.

Prof Kamila Hawthorne, the chair of the Royal College of GPs, said the record delays for care and the uncertainty for patients about when they would finally be seen was leaving people feeling “helpless and forgotten”.

These included people with heart problems, those awaiting a hip or knee replacement, and people with potential signs of cancer whom GPs have said need to be seen urgently, she said.

In an interview with the Guardian, she voiced serious concern that some of these patients saw their health deteriorate as a direct result of the delay in accessing hospital care.

“Patients getting sicker while they are on the waiting list is something GPs see and worry about, because the risk to the patient is so much greater. It’s inevitable that some people stuck will get sicker, because that’s the nature of illness,” she said.

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Source: The Guardian, 7 May 2023

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NHS managers covering up issues - whistleblower

Managers at a medical rehabilitation unit are "covering it up" when issues are raised, a whistleblower has said.

The whistleblower claimed Cambridge Rehabilitation Unit (CRU) management bullied staff who flagged concerns over shortages and unsafe practice.

Documents detail claims of "dangerous" staffing levels, patients left in bed all day without therapy and a one-star food hygiene rating.

Through the Freedom of Information Act, the BBC discovered three whistleblowing complaints were made to the Care Quality Commission (CQC) between May and August last year.

The first said wards "run on dangerous levels of staff" and no action was taken when staff flagged concerns.

The second stated there was "bullying occurring from management when staff raise concerns regarding short staffing and unsafe practice".

They said: "When issues relating to patient safety are raised... management are 'covering it up'."

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Source: BBC News, 9 May 2023

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Pharmacies in England to offer prescriptions for seven conditions amid surgery crisis

Millions of patients in England will be able to get prescriptions for seven common conditions, plus more blood pressure checks and the contraceptive pill, directly from pharmacies under proposals to tackle the crisis in GP surgeries.

Those suffering from earache, a sore throat, sinusitis, impetigo, shingles, infected insect bites and uncomplicated urinary tract infections (UTIs) in women are set to be prescribed medicine by pharmacists without the need to see a doctor or nurse for the first time.

The reforms are designed to free up 15m GP appointments over the next two years.

The blueprint was broadly welcomed by health leaders, with Thorrun Govind, chair of the Royal Pharmaceutical Society in England, calling it a “real game-changer” for patients.

But experts said not all pharmacies would be able to offer all or any of the new services, meaning the shake-up could result in frustrated patients being “bumped from pillar to post, only to end up back at the GP”.

There are also concerns that patients may not be able to recognise the seriousness of some conditions, including whether a UTI can be classed as “uncomplicated”.

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Source: The Guardian, 9 May 2023

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Elective recovery drive at risk from product shortages, warns NHS Supply Chain

Long-running supply issues with blood collection equipment risk delaying the elective recovery, according to an internal NHS Supply Chain communication seen by HSJ.

Global supply and manufacturing delays have caused the delivery of blood collection sets, apparatus used to draw intravenous blood into vacuum tubes, by months. The problems are affecting multiple products and suppliers.

An NHS Supply Chain procurement advisory cell communication warned trusts: “There is a risk that the continued supply disruption of blood collection sets is delaying elective recovery, with providers restricting blood collection to continue to prioritise urgent procedures.” 

This is the second “important customer notice” relating to supply problems with blood collection equipment issued by the national procurement agency.

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Source: HSJ, 9 May 2023

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