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EventAt this webinar, WHO will launch two WHO publications on Medication Safety, “Global burden of preventable medication-related harm” and “Policy brief on Medication Without Harm”, to create awareness and to support implementation of the WHO Global Patient Safety Challenge: Medication Without Harm. Register
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Content ArticleSalbutamol is a selective beta2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. The nebuliser liquids are licensed for use in the management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma. A Medicines Supply Notification (MSN) issued on 14 February 2024, detailed a shortage of salbutamol 2.5mg/2.5ml and 5mg/2.5ml nebuliser liquid. The resolution date is to be confirmed. The supply issues have been caused by a combination of manufacturing issues resulting in increased demand on other suppliers. Terbutaline, salbutamol with ipratropium, and ipratropium nebuliser liquids remain available, however, they cannot support an increase in demand. Ventolin® (salbutamol) 5mg/ml nebuliser liquid (20ml) is out of stock until mid-April 2024 and cannot support an increased demand after this date.
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News ArticleThe medical regulator failed to sound the alarm over Covid vaccine side effects and should be investigated, MPs have said. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving drugs and devices and monitors side effects caused by treatments. But the all-party parliamentary group (APPG) on pandemic response and recovery, an influential group of MPs, has raised “serious patient safety concerns”. It has claimed that “far from protecting patients” the regulator operates in a way that “puts them at serious risk”. Some 25 MPs across four parties have written to the health select committee asking for an urgent investigation. In reply, Steve Brine, the health committee chairman, has said an inquiry into patient safety is “very likely”. In a letter to Mr Brine, the APPG said that there was reason to believe that the MHRA had been aware of post-vaccination heart and clotting issues as early as February 2021, but did not highlight the problems for several months. Read full story (paywalled) Source: The Telegraph, 27 February 2024 Related reading on the hub: Interview with Charlet Crichton, founder of UKCVFamily
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Content ArticleTo decrease surgical site infections after appendectomy for acute appendicitis, preoperative broad-spectrum antibiotics are often used in clinical practice. However, this treatment strategy has come under scrutiny because of increasing rates of antibiotic-resistant infections. This multisite quality improvement project aimed to decrease the treatment of uncomplicated acute appendicitis with piperacillin-tazobactam without increasing the rate of surgical site infections. The intervention had two distinct components: Updating electronic health record orders to encourage preoperative administration of narrow-spectrum antibiotics. Educating surgeons and emergency department clinicians about selecting appropriate antibiotic therapy for acute appendicitis. Patient demographics, clinical characteristics and outcomes were compared six months before and after implementation of the quality improvement intervention. The intervention successfully decreased piperacillin-tazobactam administration without increasing the rate of surgical site infections in patients with acute appendicitis.
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News Article
ADHD drugs shortage fuels online black market
Patient Safety Learning posted a news article in News
Drugs used to treat ADHD are being openly traded in "potentially lethal" doses to UK buyers on encrypted apps, a BBC North West investigation has found. Criminals are cashing in on a national shortage to offer the prescription tablets in a secret mail-order service. The BBC found an unregulated online market stacked with medication which high street chemists were struggling to stock. It is feared patients are turning to the black market in desperation, but one psychiatrist has warned some of the drugs could contain other potentially harmful chemicals. Thousands of people with ADHD have been unable to get prescribed medication amid a major supply shortage. The BBC has heard how the situation has left children and adults in limbo and with the shortage set to last until December many are believed to be turning to illegitimate traders to help treat the condition. The BBC took these findings to Dr Morgan Toerien, associate specialist in mental health at Beyond Clinics in Warrington, who said: "A lot of these drugs are potentially lethal, not just dangerous - particularly if you weren't used to taking them and if you took a higher dose. "During my work in illicit drug treatment, we've tested people alleged to have taken a lot of the drugs seen on this channel and they don't actually contain what they say they do." He said people could be taking a tablet purporting to be to treat ADHD, but could be "far more dangerous". Read full story Source: BBC News, 28 February 2024 -
News Article
'Daily life is a struggle without my ADHD medicine'
Patient Safety Learning posted a news article in News
"Taking medication meant my brain was quiet for the first time; it was amazing, I cried because I was so happy," Jass Thethi, whose life was transformed after an ADHD diagnosis just over a year ago, told a BBC North West investigation. But the 34-year-old's joy was short-lived because, like more than 150,000 others who live with the condition and are reliant on medication, Jass has been affected by a UK-wide medicine shortage that started in September. Jass, who lives in Levenshulme, Greater Manchester, said: "When the medication shortage started I had to go back to white knuckling everyday life… I had to take the decision to change things and I had to quit the job I was doing." The charity ADHD UK said it had recorded a "significant decline" in the availability of medicines, with only 11% having their normal prescription in January, a drop from 52% in September. The Department of Health and Social Care (DHSC) said increased global demand and manufacturing issues were behind the shortages. Dr Morgan Toerien, associate specialist in mental health at Beyond Clinics in Warrington, said Jass's experience was not unique and many patients' lives had been "completely destabilised". Read full story Source: BBC News, 27 February 2024 Have you (or a loved one) ever been prescribed medication that you were then unable to get hold of at the pharmacy? To help us understand how these issues impact the lives of patients and families, please share your experience and insights in our Community post. We would also like to hear from pharmacists working in community or hospital settings, and others who have insights to share on this issue. -
Content ArticleWellcome Collection long read on two women who battled through decades of medical paternalism: Marie Lyon, who took Primodos, and Dr Isabel Gal, the scientist who first raised the alarm.
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Content ArticleIn this letter to Health Secretary Steve Brine MP, members of the All Party Parliamentary Group (APPG) on Pandemic Response and Recovery raise serious concerns about the approach of the Medicines and Healthcare Products Regulatory Agency (MHRA) to patient safety. They outline problems within the MHRA that continue to put patients at serious risk of harm. The letter also highlights the role of the Independent Medicines and Medical Devices Safety Review (IMMDS), in its thorough investigation of Primodos, sodium valproate and pelvic mesh in bringing some of these concerns to the fore. It points to recent evidence presented to the APPG that indicates that the MHRA is at the heart of wider endemic failings, with issues uncovered so far being "the tip of a sizeable iceberg of failure." The letter outlines concerns about the following areas: The Yellow Card Scheme Conflicts of interest and transparency History of regulatory failures in the MHRA It calls on the Health and Social Care Select Committee to investigate these issues and make recommendations to the government on: legislative changes as to who is obligated to report adverse drug reactions. funding changes to the MHRA. separation of regulatory approval duties from post marketing pharmacovigilance. more inclusion of patients. greater transparency across the board. proper enforcement of Part 14 of the Human Medicines Regulations 2012.
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News ArticleIn 2009, Emma Murphy took a phone call from her sister that changed her life. “At first, I couldn’t make out what she was saying; she was crying so much,” Murphy says. “All I could hear was ‘Epilim’.” This was a brand name for sodium valproate, the medication Murphy had been taking since she was 12 to manage her epilepsy. Her sister explained that a woman, Janet Williams, on the local news had claimed that taking the drug during her pregnancies had harmed her children. She was appealing for other women who might have experienced this to come forward. Murphy found the news segment that evening and watched it. “I was just stunned,” she says. “Watching that, I knew. I knew there and then that my children had been affected.” At that point, Murphy was a mother to five children, all under six, and married to Joe, a taxi driver in Manchester. “My kids are fabulous, all of them, but I’d known for years that something was wrong,” she says. “They weren’t meeting milestones. There was delayed speech, slowness to crawl, not walking. There was a lot of drooling – that was really apparent. They were poorly, with constant infections. I was always at the doctors with one of them." A call between Murphy and Janet Williams was the start of an incredible partnership. It led to the report published this month by England’s patient safety commissioner, Dr Henrietta Hughes, which recommended a compensation scheme for families of children harmed by valproate taken in pregnancy. Hughes has suggested initial payments of £100,000 and described the damage caused by the drug as “a bigger scandal than thalidomide”. It is estimated that 20,000 British children have been exposed to the drug while in the womb. Williams and Murphy have campaigned relentlessly to reach this point. It is by no means the endpoint – even now, an estimated three babies are born each month having been exposed to the drug. Together, the women formed In-Fact (the Independent Fetal Anti Convulsant Trust) to find and support families like theirs. They were instrumental in the creation of an all-party parliamentary group to raise awareness in government. Read full story Source: The Guardian, 22 February 2024
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News ArticleCodeine linctus, an oral solution or syrup licensed to treat dry cough in adults, is to be reclassified to a prescription-only medicine due to the risk of abuse, dependency and overdose, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Codeine linctus is an opioid medicine which has previously been available to buy in pharmacies under the supervision of a pharmacist but will now only be available on prescription following an assessment by a healthcare professional. Since 2019, there have been increasing reports in the media of codeine linctus being misused as an ingredient in a recreational drink, commonly referred to as ‘Purple Drank’. The decision to reclassify the medicine has been made following a consultation with independent experts, healthcare professionals and patients. 992 responses were received. The consultation was launched by the MHRA after Yellow Card reports indicated instances of the medicine being abused, rather than for its intended use as a cough suppressant. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. Codeine linctus is an effective medicine for long term dry cough, but as it is an opioid, its misuse and abuse can have major health consequences." Alternative non-prescription cough medicines are available for short-term coughs to sooth an irritated throat, including honey and lemon mixtures and cough suppressants. Patients are urged to speak to a pharmacist for advice and not to buy codeine linctus from an unregistered website as it could be dangerous. Read full story Source: MHRA, 20 February 2024
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Content ArticleNorth Central London Integrated Care System has piloted new guidelines and a local dashboard to ensure there is a safety net in place for females taking sodium valproate.This is a paywalled article published by the Pharmaceutical Journal.
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Content ArticleOn the 7 February 2024, the Patient Safety Commissioner for England published a report considering options for redress for those who have been harmed by two of the interventions covered by the Independent Medicines and Medical Devices Safety Review: sodium valproate and pelvic mesh. In this blog, Patient Safety Learning sets out the background to this report, outlines responses from patient groups and campaigners, and reflects on how this work will be taken forward.
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News Article
Woman worried after no ADHD medicine for months
Patient Safety Learning posted a news article in News
A woman said she has been unable to get her ADHD medication for months. Hannah Huxford, 49, from Grimsby is one of thousands of patients unable to get hold of medicine to manage their symptoms due to a national shortage. Mrs Huxford, who was diagnosed with the condition two years ago, described the situation as a "huge worry". The Department of Health and Social Care (DHSC) said it had taken action to improve the supply of medicines but added that "some challenges remain". Mrs Huxford said the medicine made a "huge difference" and got her life back on track. "It enables me to function and concentrate so I can be more proactive, I can be more productive," she explained. She said she had been unable to get her usual supply since October 2023 and has to ration what she can get hold of. "Christmas time it was just getting beyond a joke. I was going back to the pharmacy, probably two or three times in a month, just to collect the little IOUs and it was getting to the point where that, in itself, was becoming a stress," she said. "All of a sudden, if this medication is taken away from me, I'm frightened that I will go back to not being able to cope." James Davies, from the Royal Pharmaceutical Society, said the supply shortage has been caused by manufacturing problems and an increase in demand. "There are more people who are being diagnosed with ADHD, more people seeking to access ADHD treatments. That's not just related to the UK, this is a global problem," he said. Mr Davies said some ADHD medication has come back into stock but added "it's quite a fluid situation at the moment". Read full story Source: BBC News, 19 February 2024 Have you (or a loved one) ever been prescribed medication that you were then unable to get hold of at the pharmacy? To help us understand how these issues impact the lives of patients and families, please share your experience and insights in our community thread on the topic: You'll need to register with the hub first, its free and easy to do. We would also like to hear from pharmacists working in community or hospital settings, and others who have insights to share on this issue. What barriers and challenges have you seen around medication availability? Is there anything that can be done to improve wider systems or processes? -
Content ArticleOn 29 December 2022, Shahzadi Khan was detained under section 2 of the Mental Health Act due to her mental state and the risks she presented. She was found to have had a manic episode with psychotic symptoms. Due to a lack of beds, she was placed in a privately-run mental health hospital in Norfolk. She remained there until her discharge to the family home on 26 January 2023. She was commenced on Olanzapine and Zopiclone for her mental health whilst an inpatient. Her diagnosis on discharge was mania with psychotic symptoms. She was to remain on olanzapine in the community. Her placement out of area contributed to disjointed and inadequate discharge planning to support her in the community and was exacerbated by poor communication between the team managing out of area placements and the local team. As a consequence, the aftercare planning did not take place in accordance with S117 Mental Health Act. This was exacerbated by a failure by all health professionals involved in her care within the mental health trust to recognise that she needed to be referred on to the Trafford Shared Care pathway. A referral would have ensured she received support and care for at least 12 weeks when she returned to the community. There is no clear reason for this failure. She was seen by the Home-Based Treatment Team (HBTT) on 28 January and 2 February, then discharged back to her GP. Within a week of that discharge from HBTT, which meant she had been left with no mental health support, she had deteriorated significantly. On 9 February her GP sent her to hospital for emergency assessment due to her presentation. She was discharged home to be seen by the Home- Based Treatment Team on 11th February. She was seen by that team on 11, 12, and 13 February. There was still no recognition of the fact that the Trafford policy was not being followed. She had indicated her lack of compliance with olanzapine, suicidal thoughts and her behaviour on 13th February was erratic. On 14 February 2023 she took a fatal overdose of prescribed zopiclone at her home address.
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Content ArticleThe National Institute for Health and Care Excellence (NICE) pioneered the Health Technology Assessment (HTA) processes and methodologies. Technology appraisals (TAs) focus on pharmaceutical products and clinical and economic data, which are presented by the product manufacturers to the NICE appraisal committee for decision-making. Uncertainty in data reduces the chance of a positive outcome from the HTA process or requires a higher discount. This study in the BMJ Open aimed to investigate the quality of clinical data submitted by product manufacturers to NICE. The authors found that the primary components of clinical evidence influencing NICE’s decision-making framework were of poor quality. They argue that there is a need to generate robust clinical data for premarket and postmarket introduction of medicines into clinical practice, to ensure they deliver benefits to patients.
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Content ArticleMedication errors in ambulatory care settings present unique patient safety challenges. This systematic review explored the prevalence of medication errors in outpatient and ambulatory care settings. Findings indicate that prescribing errors (e.g., dosing errors) are the most common type of medication error and are often attributed to latent factors, such as knowledge gaps.
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Content ArticleThis study aimed to assess whether the risk of 90-day mortality is comparable for individuals who switch early to oral antibiotics and those who continue intravenous (IV) antibiotics in the treatment of uncomplicated gram-negative bacteremia. The results suggest that transition to oral antibiotics within four days after initial blood culture may be an effective alternative to prolonged IV antibiotic treatment for uncomplicated gram-negative bacteremia.
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News ArticleCommunity Pharmacy Scotland (CPS) is calling for all pharmacy staff to be allowed to prepare and assemble medication without requiring supervision from a pharmacist or pharmacy technician. Its comments came in its response to a Department of Health and Social Care consultation on pharmacy supervision, published on 7 December 2023, which sets out proposals to amend the Medicines Act 1968 and The Human Medicines Regulations 2012. The consultation includes proposals to enable pharmacists to authorise pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, sale and supply of medicine; to enable pharmacists to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist; and to allow pharmacy technicians to supervise the preparation, assembly and dispensing of medicines in hospital aseptic facilities In its response, the CPS disagreed with the first of these proposals, arguing that “the preparation and assembly of [pharmacy] and [prescription-only] medications can be safely carried out from a registered pharmacy premises, without requiring supervision by a Responsible Pharmacist or an authorised pharmacy technician”. CPS also said there is “a major flaw in the logic” of the government proposal because “it relies heavily on individuals rather than on safe systems”, making the proposed new way of working “vulnerable to changes in personal circumstance”. “The environment, technology, training, conditions and [standard operating procedures] in the community pharmacy setting have a bigger effect on safety of preparation and assembly than supervision by an individual,” the response said. Read full story Source: The Pharmaceutical Journal, 12 February 2024
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News ArticleAlzheimer's patients could lose out on two groundbreaking new drugs because the NHS is unprepared, a leading charity has told BBC Panorama. Lecanemab and donanemab slow down the early stages of the disease - which is the most common form of dementia. But Alzheimer's Research UK says the NHS is not ready to roll out the drugs, which could be licensed this year. The treatments would then be subject to an assessment of cost and benefits before they are made available. Lecanemab and donanemab represent a step forward because they target one of the causes of Alzheimer's, rather than treating the symptoms. However, their effectiveness depends on early diagnosis - and very few people have the specialist scans or investigations which would be needed. Questions also remain over potentially harmful side-effects of the drugs and whether the benefit they offer represents value for NHS money. Read full story Source: BBC News, 12 February 2024
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Content ArticleDespite progress on patient safety since the publication of the Institute of Medicine’s 1999 report, To Err Is Human, significant problems remain. Human factors and systems engineering (HF/SE) has been increasingly recognized and advocated for its value in understanding, improving, and redesigning processes for safer care, especially for complex interacting sociotechnical systems. However, broad awareness of HF/SE and its adoption into safety improvement work have been frustratingly slow. We provide an overview of HF/SE, its demonstrated value to a wide range of patient safety problems (in particular, medication safety), and challenges to its broader implementation across health care. We make a variety of recommendations to maximise the spread of HF/SE, including formal and informal education programmes, greater adoption of HF/SE by health care organisations, expanded funding to foster more clinician-engineer partnerships, and coordinated national efforts to design and operationalise a system for spreading HF/SE into health care nationally.
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News ArticleCampaigners have accused the UK government of betraying them after a review of redress for victims of health scandals excluded families who may have been affected by the hormone pregnancy test Primodos. A report published on Wednesday by the patient safety commissioner, Dr Henrietta Hughes, found a “clear case for redress” for thousands of women and children who suffered “avoidable harm” from the epilepsy treatment sodium valproate and from vaginal mesh implants. But despite the commissioner wanting to include families affected by hormone pregnancy tests in her review, the Department of Health and Social Care (DHSC) told her they would not be included. Primodos was an oral hormonal drug used between the 1950s and 70s for regulating menstrual cycles, and as a pregnancy test. Hormone pregnancy tests stopped being sold in the late 1970s and manufacturers have faced claims that such tests led to birth defects and miscarriages. Last year, the high court dismissed a case brought by more than 100 families to seek legal compensation owing to insufficient new evidence. The Hughes report states: “Our terms of reference did not include the issue of hormone pregnancy tests. This was a decision taken by DHSC and should not be interpreted as representing the views of the commissioner on the avoidable harm suffered in relation to hormone pregnancy tests or the action required to address this. “The patient safety commissioner wanted them included in the scope but, nevertheless, agreed to take on the work as defined by DHSC ministers.” Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests, said the families of those who took the tests felt “left out in the cold” and betrayed that they were not included in the commissioner’s review. “I feel betrayed by the patient safety commissioner, by the IMMDS [Independent Medicines and Medical Devices Safety] review and by the secretary of state for health – all three have betrayed our families because, basically, they have just forgotten us. It’s a case of ‘it’s too difficult so we will just focus on valproate and mesh’,” Lyon said. Prof Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, who led a systematic review of Primodos in 2018, said: “It’s unclear to me how the commissioner can keep patients safe if they are blocked and don’t have the power to go to areas where patient safety matters.” Read full story Source: The Guardian, 7 February 2024
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News Article
Mesh and sodium valproate scandal victims need payouts soon, report says
Patient Safety Learning posted a news article in News
Families of children left disabled by an epilepsy drug and women injured by pelvic mesh implants should be given urgent financial help, England's patient safety commissioner has said. Dr Henrietta Hughes has called on the government to act quickly to help victims of the two health scandals. It follows a review which found lives had been ruined because concerns about some treatments were not listened to. It is estimated that, since the early 1970s, about 20,000 babies have been born with disabilities after foetal exposure to sodium valproate, which can harm unborn babies if taken in pregnancy. Scientific papers from as early as the 1980s suggested valproate medicines were dangerous to developing babies, yet warnings about the potential effects were not added to some packaging until 2016. Some families affected have been campaigning for decades to raise awareness of the potential effects of the drug, with some calling for compensation and a public inquiry. Dr Hughes was asked by the government to look into a potential compensation scheme for those affected by that scandal, as well as the one involving some 10,000 women who were injured by their pelvic mesh implants - a treatment for pelvic organ prolapse (POP) and incontinence. Read full story Source: BBC News, 7 February 2024 -
Content ArticleIn late 2023, the Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, asked the Patient Safety Commissioner for England to explore redress options for those who have been harmed by pelvic mesh and sodium valproate. This report sets out the outcome of this project and is designed to help the government understand the options available for providing redress to those patients harmed by pelvic mesh and valproate.
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News Article
‘Get on with it’: patient champion demands epilepsy drug redress
Patient Safety Learning posted a news article in News
Ministers must begin paying compensation to the families of children disabled by the epilepsy drug sodium valproate by next year, a report will say this week. The report’s author, Dr Henrietta Hughes, England’s patient safety commissioner, says valproate is “a bigger scandal than thalidomide, in terms of the numbers of people affected”. She will back calls for financial redress for the thousands of children left physically and mentally disabled. Every month, three babies are still being born who have been exposed to the drug. Speaking before the report’s launch, Hughes, 54, a GP, said the state had failed pregnant women by not telling them about key information regarding the drug’s risks. “These families have already been betrayed, because they weren’t given the right information to be able to make decisions to keep themselves and their family safe,” she said. “There are senior politicians of every stripe who have expressed their sincere sympathy and support for patients who have been harmed. I take the view that people who seek high office need to also accept the responsibility that comes with that high office. “The time for redress is now. The government is responsible. I’ve been asked to give them options for redress and I’ve done that. They have the recommendations, they have the advice, they have everything they need. Get on with it.” Read full story (paywalled) Source: The Times, February 2024 -
Content ArticleChildren are more than twice as likely as adults to experience a medication error at home. In this interview for the journal Patient Safety, Dr Kathleen Walsh, paediatrician at Boston Children’s Hospital, discusses why that is the case and provides some tips to keep children—and adults—safe.
