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News Article
WHO issues alert over another India-made cough syrup
Patient Safety Learning posted a news article in News
The World Health Organization (WHO) has said that a batch of contaminated India-made cough syrup has been found in the Marshall Islands and Micronesia. The WHO said that the tested samples of Guaifenesin TG syrup, made by Punjab-based QP Pharmachem Ltd, showed "unacceptable amounts of diethylene glycol and ethylene glycol". Both compounds are toxic to humans and could be fatal if consumed. The WHO statement did not specify if anyone had fallen ill. The latest alert comes months after the WHO linked other cough syrups made in India to child deaths in The Gambia and Uzbekistan. Sudhir Pathak, managing director of QP Pharmachem, told the BBC that the company had exported the batch of 18,346 bottles to Cambodia after getting all due regulatory permissions. He said he didn't know how the product had reached the Marshall Islands and Micronesia. Read full story Source: BBC News, 26 April 2023 -
News Article
Alternative to epidural recommended for women in labour
Patient Safety Learning posted a news article in News
Women in labour should be offered an alternative to an epidural spinal block injection, say new draft guidelines for the NHS. The National Institute for Health and Care Excellence (NICE) is recommending remifentanil, which is a fast-acting morphine-like drug given into a vein. Women control the medication themselves, by pressing a button to get more of the drug for pain relief. A timer ensures the user cannot administer too much of it. Women who decide to try remifentanil and do not like it could still decide to have an epidural instead if there is no medical reason why they should not. They can use gas and air, also called Entonox, which is a mix of oxygen and nitrous oxide, at the same time. NICE says having remifentanil as a treatment option has advantages - it might enable women to be more mobile than with an epidural, which makes the legs numb and weak, for example. Evidence suggests fewer epidurals might mean fewer births using instruments like forceps and ventouse vacuum suction, says NICE. Read full story Source: BBC News, 25 April 2023 -
News ArticleChronically ill patients across the UK allege they've had to go without vital medication amid delays by a private company contracted by the NHS to deliver drugs. In the last year alone, Sciensus was awarded NHS contracts worth more than £5 million, despite being placed into special measures by health regulators in 2021 following widespread delivery failings. ITV News has revealed that the CQC is currently reviewing whether to take further regulatory action against Sciensus, having been made aware of concerns about the company’s performance. The company, which is based in Burton-on-Trent and says it "works with every NHS Trust in the country", should provide a lifeline for those who rely on specialised medications. These include those with long-term conditions - like cancer, HIV, and haemophilia - which often require drugs that can't be collected from high street or hospital pharmacies. One new mother with rheumatoid arthritis said she was taken to A&E after Sciensus left her without medication for three weeks. The 37-year-old, who wishes to remain anonymous, told ITV News: "I was unable walk with a small baby... it was such a chronic flare that I couldn't walk, which I've never, ever had before in my life." Read full story Source: ITV News, 21 April 2023
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News Article
Mifepristone: US Supreme Court delays abortion pill access decision
Patient Safety Learning posted a news article in News
The US Supreme Court has extended until Friday a temporary block on limits to access of a popular abortion pill. A Texas judge suspended approval of abortion drug mifepristone on 7 April, questioning its safety. Parts of that decision were upheld on appeal, prompting the Biden administration to make an emergency request to the Supreme Court. It's the most significant such case since the Supreme Court last year ended the nationwide right to abortion. The pill - used in more than half of abortions in the US - was first approved by the Food and Drug Administration (FDA) more than two decades ago. Critics say that by overriding the FDA's approval, the court in Texas has usurped the federal health agency's remit to regulate food, medicine, and medical devices. Legal experts warn the ruling opens the door for challenges to other approved medicines in the US and could also stifle development of future drugs. Read full story Source: BBC News, 20 April 2023 -
News Article
NHS Ayrshire & Arran team hailed for Parkinson's medication breakthrough
Patient Safety Learning posted a news article in News
A team from NHS Ayrshire & Arran has successfully created a system to ensure that people with Parkinson’s get their medication on time while they are in hospital. Parkinson’s nurse specialist Nick Bryden, who led the team, explains: “The timely administration of medication is hugely important in helping to control symptoms in people with Parkinson’s. "Guidance states that Parkinson’s medication should be administered within 30 minutes, either side, of the prescribed time which can be challenging within a busy hospital ward environment." Nick, who works out of Biggart Hospital in Prestwick, added: “When we initially worked with our digital pharmacist, Richard Cottrell, it was to develop a system that would alert us to when a Parkinson’s patient was admitted to hospital. "It then became clear that we could take the system a step further and use it to monitor if people are on the right medication and whether or not it is being administered at the right time.” The team worked to develop a further system of clear visual prompts with NHS Digital services, which appear alongside relevant patient details on wards’ electronic whiteboards. Every patient prescribed Parkinson’s medication has a tulip symbol beside their name which changes colour and flashes when it’s close to the time to administer the medication. The system was initially piloted in a couple of wards and, due to its success, has now been rolled out to almost every ward in Ayrshire and Arran. Read full story Source: The Herald, 19 April 2023 Related reading on the hub: Top picks: Seven resources about Parkinson’s Professionals with Parkinson’s tackle time critical patient safety issue: a blog by Sam Freeman Carney -
News Article
Pharmacies on ‘brink of collapse’ in England
Patient Safety Learning posted a news article in News
England’s pharmacies are on the brink of collapse – struggling with a shortage of staff and medical supplies – combined with increased patient demand and soaring costs, according to an industry survey shared exclusively with this programme. Staff say that some patients are so frustrated by the supply problems, they’re getting aggressive. The Pharmaceutical Services Negotiating Committee, the industry body which carried out the survey, says the Government and NHS need to step in now, before it’s too late. View video Source: Channel 4 News, 12 April 2023 -
News ArticleThe manufacturer of eyedrops recently linked to deaths and injuries lacked measures to assure sterility at its factory in India, according to U.S. health inspectors. Food and Drug Administration officials uncovered about a dozen problems with how Global Pharma Healthcare made and tested its eyedrops during an inspection from late February through early March. The FDA released its preliminary inspection report Monday. The company uses procedures that can’t actually ensure its products are sterile, FDA staff wrote. In particular, the inspectors found that the plant had used “a deficient manufacturing process” between December 2020 and April 2022 for products that were later shipped to the US. The plant in India’s southern Tamil Nadu state produced eyedrops that have been linked to 68 bacterial infections in the U.S., including three deaths and eight cases of vision loss. Four people have had their eyeballs surgically removed due to infection. The drops were recalled in February by two U.S. distributors, EzriCare and Delsam Phama. In a statement, the FDA's Jeremy Khan wrote, “We urge consumers to stop using these products which may be harmful to their health.” Read full story Source: NBC News, 4 April 2023
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News Article
Cancer drug leaflets for patients in Europe omit important facts
Patient Safety Learning posted a news article in News
Cancer drug information leaflets for patients in Europe frequently omit important facts, while some are “potentially misleading” when it comes to treatment benefits and related uncertainties, researchers have found. Cancer is the biggest killer in Europe after heart conditions, with more than 3.7m new cases and 1.9m deaths every year, according to the World Health Organization. Medicines are a vital weapon against the disease. But critical facts about them are often missing from official sources of information provided to patients, clinicians and the public, according to a study led by researchers from King’s College London, Harvard Medical School and the University of Sydney, among others. “Regulated information sources for anticancer drugs in Europe fail to address the information needs of patients,” the study’s authors wrote in The BMJ journal. “If patients lack access to such information, clinical decisions may not align with their preferences and needs.” Read full story Source: The Guardian, 29 March 2023 -
News Article
Cough medicines containing pholcodine withdrawn over safety fears
Patient Safety Learning posted a news article in News
Certain cough medicines sold behind the counter at pharmacies are being withdrawn over safety concerns. Health experts say there is a very rare chance that some people could experience an allergic reaction linked to an ingredient called pholcodine. People should check the packaging of any cough tablets or syrups they have at home to see if pholcodine is listed among the ingredients. If it is, talk to your pharmacist about taking a different medicine. Products containing pholcodine do not need a prescription, but cannot be bought without consultation with the pharmacist as they are kept behind the counter. The Medicines and Healthcare Products Regulatory Agency (MHRA) described removing the products from sale as a precautionary measure. Read full story Source: BBC News. 15 March 2023 -
News Article
USA: Top 10 patient safety concerns for 2023
Patient Safety Learning posted a news article in News
The US Emergency Care Research Institute (ECRI) has said the paediatric mental health crisis is the most pressing patient safety concern in 2023. ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list. Here are the 10 patient safety concerns for 2023, according to the report: 1. The pediatric mental health crisis 2. Physical and verbal violence against healthcare staff 3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine 4. Impact on clinicians expected to work outside their scope of practice and competencies 5. Delayed identification and treatment of sepsis 6. Consequences of poor care coordination for patients with complex medical conditions 7. Risks of not looking beyond the "five rights" to achieve medication safety 8. Medication errors resulting from inaccurate patient medication lists 9. Accidental administration of neuromuscular blocking agents 10. Preventable harm due to omitted care or treatment For the number one spot, ECRI said the COVID-19 pandemic raised the situation, which includes high rates of depression and anxiety among children, to crisis levels. ECRI President and CEO Marcus Schabacker, MD, PhD, said social media, gun violence and other socioeconomic factors were fueling the issue, but COVID-19 pushed it into a crisis. "We're approaching a national public health emergency," Dr. Schabacker said in a statement. Read full story Source: Becker's Hospital Review, 13 March 2023 -
Content ArticleThis Quality Standard from the National Institute for Health and Care Excellence (NICE) has been updated to instruct healthcare professionals to diagnose women under the age of 65 with a urinary tract infection (UTI) if they have two or more key symptoms.
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Content ArticleIn this article, published by the Pharmaceutical Journal, Julia Robinson reviews the data and action taken so far to reduce avoidable harm caused by sodium valproate. Julia says that while there has been some progress in managing the risks of sodium valproate, babies are still being born after exposure to the drug, and safety concerns over antiepileptic use in men and women are multiplying.
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Content Article
A bitter pill: Primodos (Sky News, 3 January 2023)
Patient-Safety-Learning posted an article in Medication
This Sky News investigation looks at one of the pharmaceutical industry's biggest scandals—the hormone pregnancy test Primodos which was prescribed to pregnant mothers in the UK between 1958 and 1978. Primodos was found to lead to birth defects, miscarriages and stillbirth, and regulatory failings led to avoidable harm to thousands of babies. -
Content ArticleThere is little longitudinal information about the type and frequency of harm resulting from medication errors among outpatient children with cancer. This study aimed to characterise rates and types of medication errors and harm to outpatient children with leukaemia and lymphoma over 7 months of treatment.
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Content ArticleIn this study, Hawkins and Morse explored nurses’ work in the context of medication administration, errors and the organisation. Secondary analysis of ethnographic data included 92 hours of non-participant observation, and 37 unstructured interviews with nurses, administrators, and pharmacists. Think-aloud observations and analysis of institutional documents supplemented these data. Findings revealed the nature of nurses’ work was characterised by chasing a standard of care, prioritising practice and renegotiating routines. The rich description identified characteristics of nurses’ work as cyclical, chaotic and complex, shattering studies that explained nurses’ work as linear. A new theoretical model was developed, illustrating the inseparability of nurses’ work from contextual contingencies and enhancing our understanding of the cascading components of work that result in days that spin out of the nurses’ control. These results deepen our understanding why present efforts targeting the reduction of medication errors may be ineffective and places administration accountable for the context in which medication errors occur.
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Content Article
Patient Safety Commissioner: 100 Days Report (2 February 2023)
Patient Safety Learning posted an article in England
In this report, Dr Henrietta Hughes, Patient Safety Commissioner for England, reflects on her first 100 days in this new role. She sets out what she has heard, what she has done and her priorities for the year ahead. -
Content ArticleChronic pain is common and debilitating, affecting about one in five people globally. However, chronic pain can be difficult to treat, and management is often suboptimal. The 2021 National Institute for Health and Care Excellence guideline for chronic primary pain explicitly recommends against the use of pain medicines, with the exception of antidepressants. To provide patients and clinicians with an updated and comprehensive resource on the efficacy, safety, and tolerability of antidepressants to treat pain, Ferreira et al. conducted an overview of relevant systematic reviews. The study found no review could provide high certainty evidence on the effectiveness of antidepressants for pain for any condition. Nine reviews did provide evidence that some antidepressants were effective, such as moderate evidence suggesting serotonin-norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, were effective for back pain, post-operative pain, fibromyalgia and nerve pain. However, the study only found low certainty evidence that selective serotonin reuptake inhibitors (SSRIs) were effective for people with depression and pain related to other conditions, and that tricyclic antidepressants (TCAs) were effective for irritable bowel syndrome, nerve pain and chronic tension-type headaches. The findings suggest that a more nuanced approach is needed when prescribing antidepressants for pain conditions.
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Content ArticleIn this video, Leah Coufal’s mother, Lenore Alexander, recounts the tragic story of her 12-year-old daughter’s preventable death in hospital in December 2002. Leah died from opioid-induced respiratory depression due to a lack of continuous postoperative monitoring which could have saved her life. Lenore now campaigns for the legal requirement to monitor patients on opioids after surgery.
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Content ArticleIn this YouTube video, Jerika T. Lam, Associate Professor at Chapman University, School of Pharmacy, offers insights on patient safety from a pharmacist’s perspective. As someone who works in a clinic that serves marginalised and underserved communities, she describes the important role pharmacists can play on a healthcare team alongside doctors and nurses to ensure patients get the appropriate medications with minimal drug interactions.
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Content ArticleThis paper aims to highlight how to reduce medication errors through the implementation of human factors science to the design features of medication containers. Despite efforts to employ automation for increased safety and decreased workload, medication administration in hospital wards is still heavily dependent on human operators (pharmacists, nurses, physicians, etc.). Improving this multi-step process requires its being studied and designed as an interface in a complex socio-technical system. Human factors engineering, also known as ergonomics, involves designing socio-technical systems to improve overall system performance, and reduces the risk of system, and in particular, operator, failures. The incorporation of human factors principles into the design of the work environment and tools that are in use during medication administration could improve this process. During periods of high workload, the cognitive effort necessary to work through a very demanding process may overwhelm even expert operators. In such conditions, the entire system should facilitate the human operator’s high level of performance. Regarding medications, clinicians should be provided with as many perceptual cues as possible to facilitate medication identification. Neglecting the shape of the container as one of the features that differentiates between classes of medications is a lost opportunity to use a helpful characteristic, and medication administration failures that happen in the absence of such intentional design arise from “designer error” rather than “user error”. Guidelines that define a container’s shape for each class of medication would compel pharmaceutical manufacturers to be compatible and would eliminate the confusion that arises when a hospital changes the supplier of a given medication.
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Content ArticleOn 4 March 2020 an investigation into the death of Yvonne Eaves was opened. The inquest came to a narrative conclusion that "The Deceased suffered from a chronic mental disorder and serious self-neglect. After compulsory admission to hospital under the Mental Health Act there was a gross failure to provide her with basic medical care which contributed to her death and it was possible that if she had received that care and VTE prophylaxis treatment she would not have developed a pulmonary thromboembolism and died."
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Content ArticleThis episode discusses the role NICE plays in patient safety. The guests are: Professor Kevin Harris, senior responsible office for patient safety at NICE, and clinical advisor to the Interventional Procedures Programme and Professor Jane Blazeby, Professor of Surgery at University of Bristol.
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Content ArticleThis study by a team at the University of Derby in the British Journal of Anaesthesia used experimental psychology methods to explore the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a visual search task. The authors found that errors were detected faster when presented in the colour-coded compartmentalised trays than in conventional trays, a finding that was replicated for correct responses for error-absent trays. Overall, colour-coded compartmentalised trays were associated with significant performance improvements when compared with conventional trays.
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Content ArticleTo date, research on adverse drug reactions (ADRs) has focused on secondary care, and there is limited studies that have prospectively examined ADRs affecting older adults in general practice. This study from Doherty et al. examined the cumulative incidence and severity of ADRs and associated patient characteristics in a sample of community-dwelling older adults. They found that over one-quarter of older adults experienced an ADR over a 6-year period. Polypharmacy is independently associated with ADR risk in general practice and older adults on ≥10 drug classes should be prioritised for regular medication review.
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Content ArticleThe Health and Social Care Select Committee have published a new report reviewing the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. This blog sets out Patient Safety Learning’s reflections on this report.
