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Found 1,165 results
  1. News Article
    The US Food and Drug Administration (FDA) has granted accelerated approval for the Alzheimer’s disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline. Lecanemab will be marketed as Leqembi, the FDA statement said. It has shown “potential” as an Alzheimer’s disease treatment by appearing to slow progression, according to Phase 3 trial results, but it has raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding. In July, the FDA accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway and granted the drug priority review, according to the company. The accelerated approval programme allows for earlier approval of medications that treat serious conditions and “fill an unmet medical need” while the drugs continue to be studied in larger and longer trials. If those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval. But if the confirmatory trial does not show benefit, the FDA has the regulatory procedures that could lead to taking the drug off the market. Read full story Source: CNN Health, 7 January 2023
  2. News Article
    NHS trusts in England have increased recruitment from low-income “red list” countries to make up for the post-Brexit loss of EU staff, despite a code of practice to safeguard health services in those developing countries. A report by the Nuffield Trust thinktank also identified shortages in vital specialist areas since Brexit, including dentistry, cardiothoracic surgery and anaesthesiology. It found that Brexit is still causing issues with the supply of medicines in Northern Ireland despite a change in the arrangements put in place by the EU last April. The report says that since 2021, the Northern Ireland protocol obliging EU trade rules to be followed in the region has led to a different set of medicines being available compared with the rest of the UK. Of the 597 products specifically approved by the Medicines and Healthcare products Regulatory Agency since Brexit, “only eight were also approved for Northern Ireland under the same name and company”. It also found that since 2021, 52 products had been granted marketing authorisation for Northern Ireland but not in Great Britain under the EU approvals system, including a painkiller from the Slovenian company Sandoz Farmacevtska Druzba designed to stop people dying from opiate overdoses. The Democratic Unionist Party (DUP) described the report as “deeply alarming”. Read full story Source: The Guardian, 7 January 2023
  3. News Article
    A shortage of cough and cold medicines in the UK is a result of ministers’ “lack of planning”, according to pharmacy leaders. Rishi Sunak’s Conservatives were accused of “being in denial” as supply chain problems worsen, with pharmacists reporting shortages of once-common cold and flu medicines. The Association of Independent Multiple Pharmacies said throat lozenges, cough mixtures and some painkillers are among the affected medicines, after issues with the supply of antibiotics and HRT last year. “Pharmacists are struggling to obtain the very basic, most common cold and flu medicine,” chief executive Leyla Hannbeck told the PA news agency. “This isn’t just the branded medicines, it is also simple things like throat lozenges, cough mixtures or painkillers – particularly the ones that are soluble. “The demand has been high because this season we’ve seen higher cases of colds and flu and people are obviously trying very hard to look after themselves and making sure that they use the relevant products to manage the symptoms. “And that has led to a shortage of these products in terms of us not being able to obtain them.” Read full story Source: The Guardian, 4 January 2023
  4. News Article
    Families of people with dementia have said there is a national crisis in care safety as it emerged that more than half of residential homes reported on by inspectors this year were rated “inadequate” or requiring improvement – up from less than a third pre-pandemic. Serious and often shocking failings uncovered in previously “good” homes in recent months include people left in bed “for months”, pain medicine not being administered, violence between residents and malnutrition – including one person who didn’t eat for a month. In homes in England where standards have slumped from “good” to “inadequate”, residents’ dressings went unchanged for 20 days, there were “revolting” filthy carpets, “unexplained and unwitnessed wounds” and equipment was ”encrusted with dirt”, inspectors’ reports showed. Nearly one in 10 care homes in England that offer dementia support reported on by Care Quality Commission inspectors in 2022 were given the very worst rating – more than three times the ratio in 2019, according to Guardian analysis. Read full story Source: 29 December 2022
  5. News Article
    German public research funder Deutsche Forschungsgemeinschaft (DFG) is conducting an audit of the clinical trials it has supported in the past. The audit was announced in response to a request from TranspariMED asking DFG for a list of all its trials completed between 2009 and 2017, to which DFG replied that it currently has no such comprehensive dataset. DFG stated that it is "currently preparing an evaluation of its clinical trials programme. In the framework of this evaluation the data you requested will be collected and analysed, as the outcomes of trials supported by DFG is of high interest including for DFG itself." TranspariMED, an organisation which aims to end evidence distortion in medicine, sees this development as a good opportunity for DFG to check whether and when clinical trials were registered and their results made public. Previous research has shown that nearly a third of German academic trials never make their results public. This not only wastes public money, but also harms patients because it leaves gaps in the evidence base on the efficacy and safety of drugs, medical devices, and non-drug treatments. Due to gaps in German law, there is still no legal obligation to make the results of many German clinical trials public. Read full story Source: TranspariMed, 20 December 2022
  6. News Article
    The number of suspected scarlet fever cases since September has risen to nearly 30,000 after the UK Health Security Agency added almost 10,000 potential new infections in the last week. More than 27,000 people could have had infections since 12 September, according to the UKHSA, who revealed on Tuesday that there were more cases than first thought because of the “significant rise” in infections. The figures come from medical practitioners referring suspected cases to the local authority or health protection team. A total of 16 children aged under 18 have died from invasive group A streptococcus (iGAS), otherwise known as strep A. Parents are advised to contact 111 or a GP surgery if a child has symptoms. They can also include nausea and vomiting. New serious shortage protocols were issued to pharmacists last week in an attempt to help those experiencing supply issues with penicillin. Chemists had widely reported problems getting hold of liquid penicillin and amoxycillin due to the increase in demand. The antibiotics are often prescribed for children who have scarlet fever or strep A. People in the industry have also reported rising prices. Pharmacists are now able to prescribe an alternative antibiotic or formulation of penicillin, such as tablets. Read full story Source: The Guardian, 20 December 2022
  7. News Article
    Private menopause clinics are prescribing HRT at "twice the recommended dose", an investigation has revealed. The investigation by The Pharmaceutical Journal has revealed that patients attending private menopause clinics are subject to “unorthodox prescribing” by providers. Many are receiving oestrogen at up to double the recommended dose placing them at higher risk of cancer and vaginal bleeding. Nuttan Tanna, a pharmacist consultant in women’s health at London North West University Healthcare NHS Trust, said she had seen referrals for “bleeding investigations” and then found the patient was on "very large doses [of oestrogen] prescribed previously by private providers”. Brendon Jiang, a senior clinical pharmacist for North Oxfordshire Rural Alliance Primary Care Network, said that his team were increasingly getting letters from private clinics requesting for patients to be prescribed doses of oestrogen that are off-label or exceed licensed recommendations. He also raised concerns that patients were not taking enough progesterone alongside increased doses of oestrogen. Taking increased doses of oestrogen alone can increase the risk of womb cancer but progesterone protects against that risk and therefore the two hormones should be taken together. Read full story (paywalled) Source: The Telegraph, 19 December 2022 Further reading on the hub: Surgical menopause: a toolkit for healthcare professionals (British Menopause Society) Menopause Support - Getting the most out of your doctor’s appointment World Menopause Day 2022: Raising awareness of surgical menopause All-Party Parliamentary Group on Menopause: Inquiry to assess the impacts of menopause and the case for policy reform - conclusions
  8. News Article
    Three more children have died from strep A, it has emerged, and pharmacists in the UK have been told they can supply alternative antibiotics to those originally prescribed, in a bid to ease shortages of certain forms of penicillin. The UK Health Security Agency (UKHSA) data shows at least 19 children have now died across the UK, while there are 7,750 cases of scarlet fever so far this season. This is more than treble the 2,538 at the same point in the year during the last comparably high season in 2017 to 2018. The Department of Health and Social Care (DHSC) has issued serious shortage protocols (SSPs) for three penicillin medicines amid increased demand for the antibiotics. Pharmacists and GPs in the UK have faced serious difficulties in securing supplies of penicillin and amoxycillin, antibiotics used to treat infections including strep A. As a result, parents have reported having to visit a string of pharmacies to obtain medicines prescribed for their sick children, while the price of some antibiotics has risen sharply – a situation pharmacists say has left them facing losses. The health minister Will Quince said: “The increased demand for the antibiotics prescribed to treat strep A has meant some pharmacists have been unable to supply the medicine shown on the prescription. “These serious shortage protocols will allow pharmacists to supply an alternative form of penicillin, which will make things easier for them, patients, and GPs. “We are taking decisive action to address these temporary issues and improve access to these medicines by continuing to work with manufacturers and wholesalers to speed up deliveries, bring forward stock they have to help ensure it gets to where it’s needed, and boost supply to meet demand as quickly as possible.” Read full story Source: The Guardian, 15 December 2022
  9. News Article
    Pharmacists say supplies of key antibiotics to treat strep A have "gone from bad to worse" in the past week. The Association of Independent Multiple Pharmacies (AIMP) said the situation was "unacceptable" and it was time for the government to get a plan in place. Four antibiotics, which treat different conditions, have been added to a list of products that the UK cannot export. The UK government says it is working urgently with manufacturers and wholesalers to speed up deliveries. However, Leyla Hannbeck, chief executive of the AIMP, which represents 4,000 pharmacies in the UK, said the supply of antibiotics to treat bacterial infections including strep A and scarlet fever was "very poor". She said the problem had been highlighted a week ago, but it was now getting worse, making it very difficult to get hold of any antibiotics. "People are having to go from one pharmacy to another - it's chaos," she said. "Supplies are not coming through to us and it feels like no-one cares." Read full story Source: BBC News, 14 December 2022
  10. News Article
    Medicine shortages are an “increasing problem” for Australia and antibiotics are among the commonly prescribed drugs currently in short supply, the peak body for general practitioners says. The drugs regulator, the Therapeutic Goods Administration (TGA), said the three most commonly prescribed antibiotics – amoxicillin, cefalexin and metronidazole – are scarce. They are used to treat a range of bacterial infections, including pneumonia and other chest infections, skin infections and urinary tract infections. To see patients through the shortage, the TGA has authorised pharmacists to provide alternative antibiotics without approval from the prescribing doctor. “Importantly, many of these medicines have alternatives available,” the TGA said. “Your pharmacist may be able to give you a different brand, or your doctor can prescribe a different strength or medicine with similar spectrum of activity.” A TGA spokesperson said “most of the antibiotic shortages are caused by manufacturing issues or an unexpected increase in demand”. Dr Nicole Higgins, the president of the Royal Australian College of General Practitioners, said the shortage of certain medicines was “becoming an increasing problem in Australia”. Read full story Source: The Guardian, 12 December 2022
  11. News Article
    A warning has been made over the possible side effects of a common NHS antibiotic by a coroner after a newly retired senior doctor died by suicide. "Respected and experienced" consultant cardiologist Robert Stevenson had no history of depression or mental health problems before he started a course of ciprofloxacin. But just over a week later, the 63-year-old went for a walk and messaged his wife to tell her he had left a note under his pillow. He was later found dead in a nearby wood. The note he had left was said to be "uncharacteristically confused and illogical" with "baseless concerns" that he might have AIDS after taking an online HIV tester kit, an inquest heard. The hearing was told Dr Stevenson hadn't been told about a "potential rare link" to suicidal behaviour in patients who took the drug, as this wasn't in line with medical guidance. Now, coroner Martin Fleming issued a warning to highlight the risk of taking the antibiotic, which is prescribed by the health service for serious conditions. Read full story Source: The Mirror, 20 June 2023
  12. News Article
    More than a quarter of patients on antidepressants in England - about two million people - have been taking them for five years, the BBC has found. This is despite there being limited evidence of the benefits of taking the drugs for that length of time. A doctor who runs an NHS clinic helping people off the pills says withdrawal symptoms can make it hard for some to stop taking their medication. Withdrawal guidance was updated in 2019, but he says little has changed. More than eight million people in England are on antidepressants - which are prescribed for depression, anxiety and obsessive compulsive disorder and other conditions. That's one million more people than five years previously, NHS prescribing figures show. The investigation also uncovered evidence that a leading drug company attempted 27 years ago to conceal possible withdrawal effects that one drug could cause. Read full story Source: BBC News, 19 June 2023
  13. News Article
    A menopause doctor says scammers using her name to illegally sell testosterone online are damaging women's health. Dr Louise Newson, who founded Newson Health, has warned patients a website has stolen her brand and logo and is selling the sex hormone unlawfully. "We do not sell medication directly to anyone online," she adds. Testosterone is illegal to sell or supply without a prescription from a health professional and currently unlicensed in the UK for use by women. However, the National Institute for Health and Care Excellence (NICE) recommends it can be considered as a supplement for menopausal woman to treat low sexual desire if HRT alone is not effective. Dr Newson, whose private clinics operate in Stratford-upon-Avon, London, Southampton and Bournemouth, said medication was only prescribed after a consultation with a clinician. "As far as we are aware no Newson Health patients have fallen victim to this scam and we sincerely hope this remains the case," she said. The practice is working with relevant organisations to have the fraudulent website taken down, she added. Read full story Source: BBC News, 16 June 2023
  14. News Article
    Peers are launching an inquiry into private health companies paid millions of pounds to courier NHS medicines in England, after the Guardian exposed how sick children and adults were being harmed by botched, delayed or missed deliveries. The House of Lords public services committee will examine “the extent of the problems in homecare medicine services”, and the impact on patients, clinicians and the wider health service. More than 500,000 patients and their families rely on private companies contracted by the NHS to deliver essential medical supplies and care to their homes. A Guardian investigation revealed how Sciensus, Britain’s biggest provider of homecare medicines services, has struggled to provide a safe or reliable service. Seriously ill children as young as four have been let down, with some becoming sicker because of failings by the company. Patients and medics have complained to Sciensus and to regulators, but little has changed. Read full story Source: The Guardian, 13 June 2023
  15. News Article
    Antidepressants can cause severe, sometimes irreversible, sexual dysfunction that persists even after discontinuing the medication. Sufferers have described it as ‘chemical castration’ – a type of genital mutilation caused by antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs). The condition is known as post-SSRI sexual dysfunction (PSSD), a condition largely unrecognised, and the true incidence of which is unknown. David Healy, psychiatrist and founder of RxISK.org said, “I saw my first patient with PSSD in 2000, a 35-year-old lady who told me that three months after stopping treatment, she could rub a hard-bristled brush across her genitals and feel nothing.” David Healy, psychiatrist and founder of RxISK.org said, “I saw my first patient with PSSD in 2000, a 35-year-old lady who told me that three months after stopping treatment, she could rub a hard-bristled brush across her genitals and feel nothing.” Josef Witt-Doerring, psychiatrist and former FDA medical officer said, “This condition is so devastating that it will cause serious changes to your life and to those around you.” Read full story Source: Maryanne Demasi, 13 June 2023
  16. News Article
    Many media stories about ketamine as a treatment for psychiatric disorders such as depression “go well beyond the evidence base” by exaggerating the efficacy, safety and longevity of the drug or by overstating the risks, an analysis has found. Researchers examined 119 articles about ketamine and mental illness published by major print media in Australia, the US and UK over a five-year period. They found articles peaked in 2019, when the US Food and Drug Administration approved a ketamine-derived nasal spray known as esketamine for treatment-resistant depression. Researchers found 37% of articles contained inaccurate information, largely related to efficacy, safety information and the longevity of the effect of the treatment. Ketamine treatment was portrayed in an “extremely positive light” in 69% of articles, the review found. “Overly optimistic statements from medical professionals regarding efficacy or safety may encourage patients to seek treatments that may not be clinically appropriate,” says the paper, published in the journal BJPsych Open. “Disconcertingly, some articles included strong statements about treatment efficacy that went well beyond the evidence base. Conversely, exaggeration of the risks may discourage patients from pursuing a treatment that may be suitable for them.” Read full story Source: The Guardian, 8 June 2023
  17. News Article
    GPs in England may start offering weight-loss jabs to some patients to reduce obesity-related illnesses and resultant pressure on hospitals. Wegovy was approved for NHS use after research suggested users could shed over 10% of their body weight. The drug blunts appetite, so users feel full and eat less. Rishi Sunak said it could be a "game-changer" as he announced a £40 million pilot scheme to increase access to specialist weight management services. But experts warn "skinny jabs" - widely used in the US and endorsed by many celebrities - are not a quick fix or a substitute for a healthy diet and exercise. NHS drugs watchdog, the National Institute for Health and Care Excellence (NICE), says patients can access Wegovy for a maximum of two years via specialist weight-management services. The new scheme will test how GPs could safely prescribe such drugs and the NHS provide support in the community or digitally, contributing to the government's wider ambition to reduce pressure on hospitals and give patients access to the care they need where it is most convenient for them. Read full story Source: BBC News, 7 June 2023
  18. News Article
    Thousands of people in England who get migraines could benefit from a drug that has been approved on the NHS. The National Institute for Health and Care Excellence (Nice), the drugs regulator, said it was recommending rimegepant for preventing migraines in the approximately 145,000 adults where at least three previous preventive treatments had failed. The drug, also called Vydura and made by Pfizer, is taken as a wafer which dissolves under the tongue. It is the first time Nice has recommended an oral treatment for preventing migraines. “Each year the lives of millions of people in England are blighted by migraine attacks,” said Helen Knight, the director of medicines evaluation at Nice. “They can be extremely debilitating and can significantly affect a person’s quality of life. “Rimegepant is the first oral treatment for migraine to be recommended by Nice and for many thousands of people it is likely to be a welcome and more convenient addition to existing options for a condition that is often overlooked and undertreated.” Read full story Source: The Guardian, 31 March 2023
  19. News Article
    The US Food and Drug Administration has proposed to add to what you get with your prescription drugs. The proposed rule would require the prescriptions you get to come with a new kind of single-page medication guide with an easy-to-use set of directions and easy-to-understand safety information, a goal the FDA has been working toward for years. One study found that nearly 75% of Americans have had trouble taking their medicine as directed. A lot of that is due to cost – people might not be able to afford their medicine, so they don’t take it – but some is due to confusion. They might get more than one kind of written information with their prescription, or the information they receive can be conflicting, incomplete or repetitive, the FDA said. When people are confused or misinformed about their prescription, there is a good chance they will not take it or will stop taking it, and that can directly hurt their health. “Research suggests that medication nonadherence can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in our country each year,” the FDA says. The agency said the new proposal is also meant to help fight the “nation’s crisis with health care misinformation and disinformation.” Read full story Source: CNN, 30 May 2023
  20. News Article
    Claims for damages by more than 170 people who say they were affected by hormone-based pregnancy test drugs have been thrown out by a High Court judge. The drugs, including Primodos, were given to women to test if they were pregnant from the 1950s to 1970s and alleged to have caused birth defects. But the judge ruled there was no new evidence linking the tests with foetal harm and "no real prospect of success". Campaigners say they are "profoundly disappointed" with the judgement. Legal action had been brought against three drug companies - Bayer Pharma, Schering Health Care, Aventis Pharma - as well as the government in a bid for compensation. However, they argued there was no evidence of a "causal association" between the hormone pregnancy tests and the harm suffered by the claimants. Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, said she was "profoundly disappointed" with the judgement. "We do not accept the defendants' claim that our evidence did not provide sufficient scientific evidence and look forward to the additional scientific evidence, to support our original argument, which is due to be published shortly," she added. Read full story Source: BBC News, 28 May 2023 Further reading on the hub: Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests
  21. News Article
    A brand-new genetic research resource, known as a ‘biobank’, will be piloted by the Medicines and Healthcare products Regulatory Agency (MHRA) in a joint venture with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines. The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait. This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup. Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. Understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies, such as the screening tests enabled through the information provided by the Yellow Card biobank. These strategies would in turn provide the opportunity to prevent rather than react to adverse drug reactions. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. Read full story Source: MHRA, 25 May 2023
  22. News Article
    A new treatment could help people to stop taking addictive opioid painkillers for chronic pain, research suggests. Data suggests there are one million people at risk from longer-term continuous opioid prescriptions, and more than 50,000 have been taking these for six months or more. While recent NHS initiatives have managed to reduce opioid prescribing by 8%, saving an estimated 350 lives, the new research has found evidence that could help many more people stop their opioid painkiller use. A team of researchers and doctors has developed and successfully trialled a programme designed to guide people in coming off prescription painkillers, tapering their opioid intake and learning how to manage their pain using alternative techniques with a course which combines one-to-one and group support. According to the findings, after one year, one in five people were able to stop taking opioids without their pain increasing. The scientists suggest the new treatment is an alternative to opioid use and has potential to give patients a better quality of life. Read full story Source: The Independent, 23 May 2023
  23. News Article
    Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels. Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns. The shortages are so acute that they are commanding the attention of the White House and Congress. The Biden administration has assembled a team to find long-term solutions for shoring up the pharmaceutical supply chain, at a time when the United States remains heavily reliant on medicines and drug ingredients from India and China. And in recent weeks, generic drug makers, supply-chain experts and patient advocates have appeared before lawmakers to discuss the problems. The scarcity of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancers has only heightened concerns. “This is, in my opinion, a public health emergency,” said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and a president-elect of the Society of Gynecologic Oncology, “because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now.” Read full story (paywalled) Source: New York Times, 17 May 2023
  24. News Article
    Nineteen suspects have been identified by police as part of a new inquiry into hundreds of deaths at a hospital. An independent panel found 456 patients died after being given opiates inappropriately at Gosport War Memorial Hospital between 1987 and 2001. The new criminal investigation is being led by Kent Police after three previous ones by Hampshire Constabulary resulted in no prosecutions. Police said interviews with the suspects under caution were ongoing. Detectives are examining more than 750 patient records as part of Operation Magenta after families, who have also campaigned for judge-led "Hillsborough-style" inquests, repeatedly called for justice. Read full story Source: BBC, 17 May 2023
  25. News Article
    The boss of a private healthcare company exposed by the Guardian for putting seriously ill children and adults at risk was warned it was failing patients three years ago. Darryn Gibson, the chief executive of Sciensus, Britain’s biggest medicines courier, was told in November 2020 that patients with bleeding disorders were being left dangerously exposed to internal bleeding with little or no treatment at home as a result of botched, delayed or missed deliveries. Gibson received the written warning from Kate Burt, the chief executive of the Haemophilia Society, a leading health charity, after she had become outraged at how vulnerable patients were being let down. Sciensus blamed IT issues and promised action. However, three years later, patients remain at “very serious” risk of harm because of “recurring” problems with the company, Burt said. “We continue to receive complaints about missing, incomplete or inaccurate deliveries and are very concerned to see the same issues recurring, indicating that far more needs to be done to improve Sciensus’s ordering and delivery systems,” she said. Read full story Source: The Guardian, 12 May 2023
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