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Found 1,115 results
  1. Content Article
    This report looks into the circumstances surrounding the deaths of three young adults; Joanna, Jon and Ben. They each had learning disabilities, were patients at Cawston Park Hospital and died within a 27 month period (April 2018 to July 2020). It highlights multiple significant failures in care, including excessive use of restraint and seclusion, overmedication of patients, lack of record keeping and the physical assault of patients. The report also makes a series of recommendations for critical system and strategic change, both at a local and national level.
  2. News Article
    Scarlet fever cases have surged by tenfold in a year, official data shows, as pharmacists grapple with a shortage of antibiotics during a Strep A outbreak. Strep A bacteria usually only causes mild illness, including scarlet fever and strep throat, which is treated with antibiotics. But in rare cases, it can progress into a potentially life-threatening disease if it gets into the bloodstream. Infections are higher than normal for this time of year, and at least nine children have died after contracting the bacteria in recent weeks. Pharmacists say they are struggling to get their hands on antibiotics to treat Strep A infections – despite the government insisting there is no shortage. “We are worried because we are having to turn patients away,” said Dr Leyla Hannbeck, the head of the Association of Multiple Pharmacies (AIMP). Read more Source: The Independent, 8 December 2022
  3. News Article
    Antibiotics could be given to children at schools affected by Strep A to stop the spread of the infection, schools minister Nick Gibb has said. Mr Gibb told Sky News that the UK Health and Security Agency (UKHSA) is "working closely with the schools involved and giving very specific advice to those schools which may involve the use of penicillin". He added that health officials will "have more to say about that". "They're providing more general advice to parents, which is to look out for the symptoms - so, sore throat, fever, high temperature and also a red or raised rash on the skin are symptoms of this invasive Strep A outbreak." His comments came after the ninth death of a child from the infection. Read full story Source: Sky News, 6 December 2022
  4. News Article
    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”. Read full story Source: WHO, 29 November 2022
  5. News Article
    With flu cases rising, UK Covid scientists are turning their attention to finding the best life-saving drugs to fight the winter virus. A trial will run across 150 hospitals this year and next, recruiting thousands of patients. Flu vaccines help prevent infection but each year some people become very sick. And antiviral tablets - given within a couple of days of symptoms developing - are designed to reduce the severity of these bad infections. One of the pills the Imperial College London team will be testing is oseltamivir, or Tamiflu. It is recommended to treat severe flu - but whether it saves lives is unclear. Funded by the National Institute for Health and Care Research, the Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (Remap-Cap) will study how good the treatments are at reducing deaths and intensive care admissions. Chief investigator Prof Anthony Gordon told BBC News: "We want to learn at pace what works, just like we did during Covid. "We'll test multiple treatments in different combinations. Some are antivirals that stop the virus, others are steroids or other treatments that work on how the body responds to infections. "We hope that our trial will help to find urgently needed flu treatments rapidly. Our Covid trial changed clinical practice globally and we hope we can impact flu treatment and reduce winter pressures on the NHS in the same way." Read full story Source: BBC News, 29 November 2022
  6. News Article
    Patients in Oklahoma, USA, who get their prescription medications by mail may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts. “This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. “We’ve got a tremendous amount of prescriptions that get mailed to patients. … What we did today was make sure our patients in Oklahoma are receiving safe products.” Exposure to extreme temperatures can degrade or weaken drugs, potentially changing their dosage or chemical makeup and rendering them ineffective or unsafe for patients. But while government oversight of how pharmacies store medications to keep them in defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found oversight of shipping to patients — during which drugs might be exposed to heat waves and below-freezing temperatures — is largely a system of blind trust. Mail-order pharmacy is a booming business, with soaring profits for some of the nation’s largest companies last year and more than 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data. NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping. Read full story Source: NBC News, 17 November 2022
  7. News Article
    Poison control centres in the USA have seen an increase in reports of children ingesting a type of prescription cough medicine, a study published by the Food and Drug Administration (FDA)found. From 2010 through 2018, reports of paediatric poisonings involving the drug, benzonatate, increased each year, the study found. Benzonatate, sold under the brand name Tessalon, is prescribed to treat coughs caused by colds or the flu. It is not approved for children younger than 10 years old. The findings, published in the journal Pediatrics, were based on more than 4,600 cases reported to poison control centres. The reports included children who were unintentionally exposed to the drug, as well as children who abused or misused it intentionally. The proportion of cases with serious adverse effects was low. However, accidental or inappropriate use of benzonatate, which comes in gel capsules, can lead to serious health problems in children, including convulsions, cardiac arrest and death. The findings should galvanise doctors to be more careful when they prescribe these kinds of medications, said study author Dr. Ivone Kim, a pediatrician and senior medical officer at the FDA. Cough medications "should be treated like any other medication that can have serious side effects," Ameenuddin said, "which means not giving it to children without specific medical direction." Read full story Source: NBC News, 15 November 2022
  8. News Article
    The antibody drug Evusheld is effective for protecting clinically extremely vulnerable people from Covid-19, including its omicron variants, a preprint study has reported. The prophylactic treatment, manufactured by AstraZeneca, is a combination of two long acting antibodies (tixagevimab and cilgavimab). It is given as two separate, sequential intramuscular injections in the same session and can be administered in the community. A research team, led by the University of Birmingham alongside academics from King’s College London and the UK Health Security Agency, carried out a systematic review and meta-analysis to examine its effectiveness in immunocompromised patients. The paper examined the outcomes among 24 773 immunocompromised participants across 17 international studies, 10 775 of whom received Evusheld. Overall, it reported that the treatment was 86% effective for preventing covid specific death, 88% effective in preventing intensive care admission, effective in preventing hospital admission, and 40% effective in preventing Covid-19 infection. The study’s senior investigator, Lennard Lee, senior research fellow at the University of Birmingham and academic medical oncologist at the University of Oxford, said, “There is strong evidence emerging across the world that this approach of using prophylactic antibody therapies in combination with vaccination is a revolutionary approach to safeguard the most vulnerable patients this winter. The science and data suggest that it would be a successful approach for many cancer and immunocompromised patients at the highest level of risk.” Evusheld is already being given to immunocompromised patients in countries including the United States, France, and Israel, but the UK government is waiting for more data on the duration of protection it provides against omicron and its subvariants before deciding whether it should be used. Read full story Source: BMJ, 8 November 2022
  9. News Article
    Responding to a backlash from pain patients in the USA, the Centers for Disease Control and Prevention (CDC) have released updated guidelines that offer clinicians more flexibility in the way they prescribe opioids for short- and long-term pain. The new recommendations eliminate numerical dose limits and caps on length of treatment for chronic pain patients that had been suggested in the landmark 2016 version of the agency’s advice, which was aimed at curbing the liberal use of the medication and controlling a rampaging opioid epidemic. Those guidelines cautioned doctors that commencing opioid therapy was a momentous decision for patients. Parts of that nonbinding document were widely misinterpreted, resulting in unintended harm to patients who were benefiting from use of opioids without much risk of addiction. Patients reported they were rapidly tapered off medication by doctors or saw their medication abruptly discontinued, the CDC acknowledged in the new document. The new 100 pages of guidance — which remain only recommendations for doctors, nurse practitioners and others authorised to prescribe opioids — emphasize returning the focus to the caregiver and patient deciding on the best course of treatment. Read full story (paywalled) Source: The Washington Post, 3 November 2022
  10. News Article
    A new pill that could prevent pre-eclampsia has become the first pregnancy drug to be fast-tracked for development by the UK’s drug regulator. Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from 20 weeks of pregnancy could stop them developing the condition. Pre-eclampsia endangers the lives of thousands of expectant mothers and their babies in the UK each year, and has no therapeutic options. Globally, it affects between 2% and 8% of pregnancies and kills up to half a million babies and 100,000 women a year. MirZyme Therapeutics has been awarded an innovative licensing and access pathway (ILAP), or so-called innovation passport, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The passport was established in January 2021 to expedite access to essential new drugs at the height of the Covid pandemic. It is granted to medicines that address the needs of patients with life-threatening and unmet medical needs, with a view to getting the drug to the market as quickly as possible. Read full story Source: The Guardian, 8 November 2022
  11. News Article
    GPs are breaching medical guidelines by prescribing antidepressants for children as young as 11 who cannot get other help for their mental health problems, NHS-funded research reveals. Official guidance says that under-18s should only be given the drugs in conjunction with talking therapies and after being assessed by a psychiatrist. But family doctors in England are “often” writing prescriptions for antidepressants for that age group even though such youngsters have not yet seen a psychiatrist, according to a report by the National Institute for Health and Care Research (NIHR), the NHS research body. The report linked the prescriptions to the long wait many young people, some self-harming or suicidal, face before starting treatment with NHS child and adolescent mental health services (CAMHS). Under-18s are prescribed the drugs for anxiety, depression, pain and bedwetting. The guidance on antidepressants has been issued by the National Institute for Health and Care Excellence (NICE), which advises the NHS on which treatments are effective. Referencing NICE’s recommendation of a two-step approval process, the NIHR study said “this often” did not happen. “No antidepressants are licensed in the UK for anxiety in children and teenagers under 18 years, except for obsessive compulsive disorder. Yet both specialists [psychiatrists] and GPs prescribe them. Thousands of children and teenagers in the UK are taking antidepressants for depression and anxiety. The numbers continue to rise and many have not seen a specialist.” Read full story Source: The Guardian, 4 November 2022
  12. News Article
    Theresa May has urged the government to consider “redress” for the victims of a hormone pregnancy test blamed for causing serious birth defects. The former prime minister said that while Primodos victims had received an apology, “lives have suffered as a result” of the drug’s use. In an interview for a Sky News documentary, she praised campaigners who had been “beating their head against a brick wall of the state” which tried to “stop them in their tracks”. A review in 2017 found that scientific evidence did “not support a causal association” between the use of hormone pregnancy tests such as Primodos and birth defects or miscarriage. But Ms May ordered a second review in 2018, because, she said, she felt that it “wasn’t the slam-dunk answer that people said it was”. “At one point it says that they could not find a causal association between Primodos and congenital anomalies, but neither could they categorically say that there was no causal link,” she said. The second review concluded last month that there had been “avoidable harm” caused by Primodos and two other products – sodium valproate and vaginal mesh. An interview for Bitter Pill: Primodos, which will air on Sky Documentaries, Ms May said: “I think it’s important that the government looks at the whole question of redress and about how that redress can be brought up for people. Read full story Source: The Independent, 28 August 2020
  13. News Article
    A senior coroner has demanded action by Simon Stevens, chief executive of NHS England, to ensure that GPs monitor repeat prescriptions properly, after an 84 year old man with dementia died from an overdose of tramadol. Peter Cole, who was found collapsed at his home in Welwyn in Hertfordshire by a neighbour, had amassed a large quantity of unused prescription drugs at his house. He had numerous drugs on repeat prescription, said Geoffrey Sullivan, chief coroner for Hertfordshire. Read full story (paywalled) Source: BMJ, 5 August 2020
  14. News Article
    Antibiotic resistance is an increasing challenge for modern medicine as more naturally occurring antimicrobials are needed to tackle infections capable of resisting treatments currently in use. New research from the University of Warwick has investigated natural remedies to fill the gap in the antibiotic market, taking their cue from a 1,000-year-old text known as Bald's Leechbook. Read the full article here.
  15. News Article
    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
  16. News Article
    Former health secretary Jeremy Hunt has warned ministers not to let the Cumberlege review “gather dust on a shelf”. The chair of the Commons Health and Social Care Committee told The Independent it was vital action was taken to implement the recommendations. Mr Hunt, who made patient safety a key focus of his tenure as health secretary, backed the idea of an independent patient safety commissioner that would be outside the NHS and have powers to advocate for patient issues. Mr Hunt said: “This report should be a powerful wake-up call that our healthcare system is still too closed, defensive and focused on blame rather than learning lessons. It’s truly harrowing to hear of all the women and families who live with permanent anguish because of these medicines and devices, and it has clearly taken too long for their voices to be heard.” “The NHS is one of the safest health systems in the world, and we’re all rightly in awe of our frontline heroes. But in healthcare getting it right ‘most’ times isn’t good enough because the exceptions wreak lifelong devastation on families. So we must not allow this seminal report to gather dust on a shelf: lessons must be learnt once and for all.” Read full story Source: The Independent, 8 July 2020
  17. News Article
    Many lives have been ruined because officials failed to hear the concerns of women given drugs and procedures that caused them or their babies considerable harm, says a review. More than 700 women and their families shared "harrowing" details about vaginal mesh, Primodos and an epilepsy drug called sodium valproate. Too often worries and complaints were dismissed as "women's problems". It says arrogant attitudes left women traumatised, intimidated and confused. June Wray, 73 and from Newcastle, experienced chronic pain after having a vaginal mesh procedure in 2009. "Sometimes the pain is so severe, I feel like I will pass out. But when I told GPs and surgeons, they didn't believe me. They just looked at me like I was mad." The chairwoman of the highly critical review, Baroness Julia Cumberlege, said the families affected deserved a fulsome apology from the government. She said: "I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself." Read full story Source: BBC News, 8 July 2020
  18. News Article
    A Scottish Government committee has found that the “profound failings” of IT systems are the biggest problem facing a medicine-prescribing service that does not sufficiently focus on patients. A report from the members of Scottish Parliament on the Health and Sport Committee describes a medicines system “burdened by market forces, public sector administrative bureaucracy and under resourcing, inconsistent leadership and a lack of comprehensive, strategic thinking and imagination, allied to an almost complete absence of useable data”. The committee particularly criticised the failure of the NHS to introduce appropriate IT systems. “We are extremely disappointed that once again all roads lead to the dismal failure of the NHS in Scotland to implement comprehensive IT systems which maximise the use of patient data to provide a better service,” the report says. Committee members are calling for an overhaul of the system to allow for collection and analysis of data that would ensure the best possible outcomes for patients and cost savings for the NHS. MSPs found a “lack of care” to understand patients’ experience of taking medicines and a lack of follow up to ensure that medicines were effective or even being used. Prescribers were “instinctively reaching for the prescription pad” and not taking the time to discuss medicines with patients, nor were the principals of realistic medicine, in which patients and clinicians share decision making about their care, being followed. Read full story Source: Public Technology.net, 1 July 2020
  19. News Article
    Police in Bristol have launched investigations into the circumstances that led to the death of a teenager with autism and learning disabilities. Avon and Somerset Police told HSJ they are investigating the circumstances behind the death of Oliver McGowan in 2016, at North Bristol Trust. They said: “As part of the enquiry [officers] will interview a number of individuals as they seek to establish the circumstances around Oliver’s death before seeking advice from the Crown Prosecution Service.” Oliver died in 2016 at Bristol’s Southmead Hospital after being admitted following a seizure. He had mild autism, epilepsy and learning difficulties. During previous hospital spells he experienced very bad reactions to antipsychotic medications, prompting warnings in his medical records that he had an intolerance to these drugs. Despite this Oliver was given anti-psychotic medication by doctors at Southmead against his own and his parents’ wishes. This led him to suffer a severe brain swelling which led to his death. His death has since prompted a national training programme for NHS staff on the care of people with autism and learning disabilities. Read full story (paywalled) Source: HSJ, 1 July 2020
  20. News Article
    Low dose dexamethasone reduces deaths in patients hospitalised with COVID-19 who need ventilation, according to preliminary results from the RECOVERY trial. The drug was also found to reduce deaths by one-fifth in other hospitalised patients receiving oxygen only, but no benefit was seen among COVID-19 patients who did not need respiratory support. The chief investigators from the University of Oxford trial said that the findings represent a “major breakthrough” which is “globally applicable” as the drug is cheap and readily available. Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and a chief investigator on the trial, added, “This is the only drug that has so far been shown to reduce mortality, and it reduces it significantly. It is a major breakthrough.” Read full story Source: BMJ, 16 June 2020
  21. News Article
    Selected NHS coronavirus patients will soon be able to access an experimental treatment to speed up their recovery, with the health secretary Matt Hancock suggesting it is probably “the biggest step forward’’ in medication since the beginning of the COVID-19 crisis. The anti-viral drug remdesivir will be made available to patients meeting certain clinical criteria to support their recovery in hospital. The drug is currently undergoing clinical trials around the world, including in the UK, and peer-reviewed data showed it can shorten the time to recovery by about four days. Treatment will initially be prioritised for patients who have the greatest likelihood of deriving the most benefit, according to the Department of Health and Social Care (DHSC). Satisfied the drug can help boost recovery, the government’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of remdesivir through its early access to medicines scheme. The experimental anti-viral drug was granted emergency authorisation to treat Covid-19 in the US by the Food and Drug Administration earlier this month. Read full story Source: The Independent, 26 May 2020
  22. News Article
    People carrying Emerade 500 microgram adrenaline auto-injector pens should return them and get hold of a prescription for a different brand. A fault has been detected in the pens, meaning the dose of adrenaline may not be delivered when needed for people with severe allergies. The official advice comes from the Medicines and Healthcare products Regulatory Agency (MHRA). Alternative brands - EpiPen and Jext - are available up to 300 micrograms. "Action has been taken to protect patients, following detection of a fault in one component of the Emerade adrenaline auto-injector pens," an MHRA spokesperson said. "Patients should return all Emerade 500 microgram pens to their local pharmacy once they have a new prescription and have been supplied with pens of an alternative brand." If an Emerade pen does need to be used before a patient can get hold an alternative pen, the advice is that it should be pressed very firmly against the thigh. If this does not work, the patient should immediately use their second pen. Read full story Source: BBC News, 19 May 2020
  23. News Article
    The government is under pressure to go further on measures to relax rules on powerful painkillers such as morphine to prevent patients suffering “unnecessary pain and distress in the last days of their lives”. On Tuesday the health secretary, Matt Hancock, announced staff in care homes and hospices would be allowed to “re-use” controlled drugs such as morphine and midazolam, with medication prescribed for one patient used for another where there is an immediate need. But the Home Office today confirmed to The Independent that it had no plans to extend the rules to the care of patients in their own homes – a restriction experts and charities have warned could leave people suffering at the end of their lives. The government announced the changes following concerns over the supply of drugs. The Royal College of GPs (RCGP) welcomed the changes announced by Mr Hancock, calling them “a significant step forward”, but added: “This only applies to patients living in care home and hospice settings, so there is still work to be done to ensure patients living in their own homes have appropriate access to necessary medication in a timely way.” Last week the RCGP wrote to home secretary Priti Patel warning that people were suffering unnecessarily due to problems accessing drugs. Read full story Source: The Independent, 30 April 2020
  24. News Article
    UK medicines agencies have changed their advice on ibuprofen to say that the drug can be used to treat patients with symptoms of COVID-19, although the evidence that prompted the revision has not been made public. The change follows a review by the Commission on Human Medicines’ expert working group on COVID-19 which, along with previous reviews of evidence, concluded that there is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and contracting or worsening of COVID-19. The group’s review has not been published, but prompted the Medicines and Healthcare Products Regulatory Agency (MHRA), NHS England, and the National Institute for Health and Care Excellence (NICE) to update their advice to say that patients can take paracetamol or ibuprofen for symptoms of COVID-19, such as fever and headache. This is a change to NICE’s recommendation on 3 April that paracetamol should be used in preference to NSAIDs for managing fever in patients with suspected COVID-19 until more evidence is available. Read full story Source: BMJ, 17 April 2020
  25. News Article
    Doctors have been warned that crucial drugs used to help sedate and ventilate patients in intensive care are running out due to the demand caused by coronavirus. An alert to hospitals from NHS England today said there were “limited supplies” of muscle relaxant drugs atracurium, cisatracurium and rocuronium, which are used during intubation when patients are sedated and paralysed with a ventilator used to help them breathe. As a result of the shortages, and to help maintain supplies, NHS England said it would now manage existing supplies “centrally”. Its said supplies of atracurium and cisatracurium were likely to be exhausted in coming days, and hospitals would need to switch to alternatives that were still available. A critical care nurse working in ICU in the south of England told The Independent they were already using alternatives but that this had to be used at different concentrations and run for longer to achieve the same sedation. She said changes like this with staff overstretched could increase the likelihood of drug errors. Read full story Source: The Independent, 17 April 2020
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