Month: April 2024

Categories : Antibiotics Respiratory DiseasesTags :

Large Study Finds Antibiotics are Ineffective for Most Lower Respiratory Tract Infections

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Photo by Robina Weermeijer on Unsplash

Use of antibiotics provided no measurable impact on the severity or duration of coughs, even if a bacterial infection was present, finds a large prospective study of people seeking care for lower-respiratory tract infections. The study by researchers at Georgetown University Medical Center and colleagues appeared in the Journal of General Internal Medicine.

“Upper-respiratory tract infections usually include the common cold, sore throat, sinus infections and ear infections and have well established ways to determine if antibiotics should be given,” says the study’s lead author, Dan Merenstein, MD, professor of family medicine. “Lower-respiratory tract infections tend to have the potential to be more dangerous, since about 3% to 5% of these patients have pneumonia. But not everyone has easy access at an initial visit to an X-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection. Plus, patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time brings a resolution to most people’s infections.”

The antibiotics prescribed in this study for lower-tract infections were all appropriate, commonly used antibiotics to treat bacterial infections. But the researchers’ analysis showed that of the 29% of people given an antibiotic during their initial medical visit, there was no effect on the duration or overall severity of cough compared to those who didn’t receive an antibiotic.

“Physicians know, but probably overestimate, the percentage of lower-tract infections that are bacterial; they also likely overestimate their ability to distinguish viral from bacterial infections,” says Mark H. Ebell, MD, MS, a study author and professor in the College of Public Health at the University of Georgia. “In our analysis, 29% of people were prescribed an antibiotic, while only 7% were given an antiviral. But most patients do not need antivirals, as there exist only two respiratory viruses where we have medications to treat them: influenza and SARS-CoV-2. There are none for all of the other viruses.”

To determine if there was an actual bacterial or viral infection present, beyond the self-reported symptoms of a cough, the investigators confirmed the presence of pathogens with advanced lab tests to look for microbiologic results classified as only bacteria, only viruses, both virus and bacteria, or no organism detected. Very importantly, for those with a confirmed bacterial infection, the length of time until illness resolution was the same for those receiving an antibiotic versus those not receiving one –about 17 days.

Overuse of antibiotics can result in dizziness, nausea, diarrhoea and rash, along with about a 4% chance of serious adverse effects including anaphylaxis, which is a severe, life-threatening allergic reaction; Stevens-Johnson syndrome, a rare, serious disorder of the skin and mucous membranes; and Clostridioides difficile-associated diarrhoea. The World Health Organization considers antibiotic resistance to be a major an emerging threat.

“We know that cough can be an indicator of a serious problem. It is the most common illness-related reason for an ambulatory care visit, accounting for nearly 3 million outpatient visits and more than 4 million emergency department visits annually,” says Merenstein. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial, as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012.”

Source: Georgetown University School of Medicine

Categories : Cancer NeurologyTags :

Scientists Evaluate Old Epilepsy Drug for Glioma Prevention

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Photo by Anna Shvets on Pexels

A drug used to treat children with epilepsy prevents brain tumour formation and growth in two mouse models of neurofibromatosis type 1 (NF1), according to a study by researchers at Washington University School of Medicine in St. Louis. NF1 is a genetic condition that causes tumours to grow on nerves throughout the body.

The findings lay the groundwork for a clinical trial to assess whether the drug, lamotrigine, can prevent or delay brain tumours in children with NF1. The study is published online in the journal Neuro-Oncology.

“Based on these data, the Neurofibromatosis Clinical Trials Consortium is considering launching a first-of-its-kind prevention trial,” said senior author David H. Gutmann, MD, PhD, professor of neurology. “The plan is to enrol kids without symptoms, treat them for a limited time, and then see whether the number of children who develop tumours that require treatment goes down.

“This is a novel idea, so we took it to an NF1 patient focus group,” Gutmann continued. “They said, ‘This is exactly what we’re looking for.’ A short-term treatment with a drug that has been used safely for 30 years was acceptable to them if it reduced the chance their children would develop tumours and need chemotherapy that might have all kinds of side effects.”

Optic gliomas, tumours on the optic nerve are the most serious type that those with NF1 get. Such tumours typically appear between ages 3 to 7. Though rarely fatal, they cause vision loss in up to a third of patients as well as other symptoms, including early puberty. Standard chemotherapy for optic gliomas is only moderately effective at preventing further vision loss and can affect children’s developing brains, resulting in cognitive and behavioural problems.

In a previous study, Gutmann and Corina Anastasaki, PhD, an assistant professor of neurology and the first author on the new paper, showed that lamotrigine stopped optic glioma growth in NF1 mice by suppressing neuronal hyperactivity. Intrigued, the Neurofibromatosis Clinical Trial Consortium asked Gutmann and Anastasaki to clarify the connection between NF1 mutation, neuronal excitability and optic gliomas; assess whether lamotrigine was effective at the doses already proven safe in children with epilepsy; and conduct these studies in more than one strain of NF1 mice.

In humans, NF1 could be caused by any one of thousands of different mutations in the NF1 gene, with different mutations causing different medical problems. Repeating experiments in multiple strains of mice was a way of gauging whether lamotrigine was likely to work in people regardless of the underlying mutation.

Anastasaki and Gutmann not only showed that lamotrigine worked in two strains of NF1 mice, they also showed that the drug worked at lower doses than those used for epilepsy, meaning that it was probably safe. Even better, they found that a short course of the drug had lasting effects, both as a preventive and a treatment. Mice with tumours and that were treated for four weeks starting at 12 weeks of age saw their tumours stop growing and even showed no further damage to the retinas. Mice that received a four-week course of the drug starting at 4 weeks of age, before tumours typically emerge, showed no tumour growth even four months after treatment had ended.

These findings have led Gutmann to suggest that a one-year course of treatment for young children with NF1, maybe between the ages of 2 to 4, might be enough to reduce their risk of brain tumours.

“The idea that we might be able to change the prognosis for these kids by intervening within a short time window is so exciting,” Gutmann said. “If we could just get them past the age when these tumours typically form, past age 7, they may never need treatment. I’d love it if I never again had to discuss chemotherapy for kids who aren’t even in first grade yet.”

Source: Washington University School of Medicine

Categories : IT in Healthcare Skeletal SystemTags :

AI Helps Clinicians to Assess and Treat Leg Fractures

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By using artificial intelligence (AI) techniques to process gait analyses and medical records data of patients with leg fractures, researchers have uncovered insights on patients and aspects of their recovery.

The study, which is published in the Journal of Orthopaedic Research, uncovered a significant association between the rates of hospital readmission after fracture surgery and the presence of underlying medical conditions. Correlations were also found between underlying medical conditions and orthopaedic complications, although these links were not significant.

It was also apparent that gait analyses in the early postinjury phase offer valuable insights into the injury’s impact on locomotion and recovery. For clinical professionals, these patterns were key to optimising rehabilitation strategies.

“Our findings demonstrate the profound impact that integrating machine learning and gait analysis into orthopaedic practice can have, not only in improving the accuracy of post-injury complication predictions but also in tailoring rehabilitation strategies to individual patient needs,” said corresponding author Mostafa Rezapour, PhD, of Wake Forest University School of Medicine. “This approach represents a pivotal shift towards more personalised, predictive, and ultimately more effective orthopaedic care.”

Dr. Rezapour added that the study underscores the critical importance of adopting a holistic view that encompasses not just the mechanical aspects of injury recovery but also the broader spectrum of patient health. “This is a step forward in our quest to optimize rehabilitation strategies, reduce recovery times, and improve overall quality of life for patients with lower extremity fractures,” he said.

Source: Wiley

Categories : Ethics and Law IT in HealthcareTags :

Admin and Ethics should be the Basis of Your Healthcare AI Stratetgy

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Technology continues to play a strong role in shaping healthcare. In 2023, the focus was on how Artificial Intelligence (AI),  became significantly entrenched in patient records, diagnosis and care. Now in 2024 the focus is on the ethical aspects of AI.  Many organisations including practitioner groups, hospitals and medical associations are putting together AI Codes of Conduct, with new legislation planning to be passed in countries such as the USA.

The entire patient journey has benefited from the use of AI, in tangible ways that we can understand. From online bookings, the sharing of information with electronic health records, keyword diagnosis, sharing of visual scans, e-scripts, easy claims, SMS’s and billing, are all examples of how software systems are incorporated into practices to facilitate a streamlined experience for both the patient and doctor. *But although 75% of medical professionals agree on the transformation abilities of AI, only 6% have implemented an AI strategy.

Strategies need to include ethical considerations

CompuGroup Medical South Africa, (CGM SA), a leading international MedTech company that has spent over 20 years designing software solutions for the healthcare industry, has identified one main area that seems to constantly be the topic for ethical consideration.

This is the sharing of patient electronic health records or EHR’s. On one hand the wealth of information provided in each EHR – from a patient’s medical history, demographics, their laboratory test results over time, medicine prescribed, a history of medical procedures, X-rays to any medical allergies – offers endless opportunities for real time patient care. On the other hand, there seems to be a basic mistrust of how these records will be shared and stored, no one wants their personal medical information to end up on the internet.

But there’s also the philosophical view that although you might not want your info to be public record, it still has the ability to benefit the care of thousands of people. If we want a learning AI system that adapts as we do, if we want a decision making support system that is informed by past experiences, then the sharing of data should be viewed as a tool and no longer a privacy barrier.

Admin can cause burnout

Based on their interactions with professionals, CGM has informally noted that healthcare practices spend 73% of their time dealing with administrative tasks. This can be broken down into 38% focusing on EHR documentation and review, 19% related to insurance and billing, 11% on tests, medications and other orders and the final 6% on clinical planning and logistics.

Even during the consultation doctors can spend up to 40% of their time taking clinical notes. Besides the extra burden that this places on health care practices, this also leads to less attention being paid to the patient and still requires 1-2 hours of admin in the evenings. (Admin being the number one cause of burnout in clinicians and too much screen time during interactions being the number one complaint by patients.)

The solution

The ability for medical practitioners to implement valuable and effective advanced technical software, such as Autoscriber, will assist with time saving, data quality and overall job satisfaction. Autoscriber is an AI engine designed to ease the effort required when creating clinical notes by turning the consultation between patient and doctor into a structured summary that includes ICD-10 codes which is the standard method of classification of diseases used by South African medical professionals    

It identifies clinical facts in real time, including medications and symptoms. It then orders and summarises the data in a format ready for import into the EHR, creating a more detailed and standardised report on each patient encounter, allowing for a more holistic patient outcome. In essence, with the introduction of Autoscriber into the South African market, CGM seeks to aid practitioners in swiftly creating precise and efficient clinical records, saving them from extensive after-hours commitments.

Dilip Naran, VP of Product Architecture at CGM SA explains: “It is clear that AI will not replace healthcare professionals, but it will augment their capabilities to provide superior patient care. Ethical considerations are important but should not override patient care or safety. The Autoscriber solution provides full control to the HCP to use, edit or discard the transcribed note ensuring that these notes are comprehensive, attributable and contemporaneous.”

Categories : COVID PaediatricsTags :

Specific Nasal Cells Protect against COVID in Children

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Legend of spirals: This image highlights the appearance of nasal cultures from older adults, revealing distinct spiral-like patterns that were absent in cultures grown from children. Credit: University College London

Important differences in how the nasal cells of young and elderly people respond to the SARS-CoV-2 virus, could explain why children typically experience milder COVID symptoms, finds a new study led by researchers at UCL and the Wellcome Sanger Institute.

The study, published in Nature Microbiology, focused on the early effects of SARS-CoV-2 infection on the cells first targeted by the viruses, the human nasal epithelial cells (NECs).

These cells were donated from healthy participants, including children (0–11 years), adults (30–50 years) and, for the first time, the elderly (over 70 years).

The cells were then cultured to regrow into the different types of nasal cells. Using single-cell RNA sequencing techniques that enable scientists to identify the unique genetic networks and functions of thousands of individual cells, the team identified 24 distinct epithelial cell types. Cultures from each age group were then either mock-infected or infected with SARS-CoV-2.

After three days, the NECs of children responded quickly to SARS-CoV-2 by increasing interferon (the first line of anti-viral defence), restricting viral replication. However, this early anti-viral effect became less pronounced with age.

The researchers also found that NECs from elderly individuals not only produced more infectious virus particles, but also experienced increased cell shedding and damage.

The strong antiviral response in the NECs of children could explain why younger people typically experience milder symptoms. In contrast, the increased damage and higher viral replication found in NECs from elderly individuals could be linked to the greater severity of disease observed in older adults.

Project lead, Dr Claire Smith (Associate Professor at UCL Great Ormond Street Institute of Child Health), said: “Our research reveals how the type of cells we have in our nose changes with age, and how this affects our ability to combat SARS-CoV-2 infection. This could be crucial in developing effective anti-viral treatments tailored to different age groups, especially for the elderly who are at higher risk of severe COVID-19.”

Co-Senior author, Dr Kerstin Meyer (Wellcome Sanger Institute), said: “By carrying out SARS-CoV-2 infections of epithelial cells in vitro and studying the responses with single cell sequencing, we get a much more detailed understanding of the viral infection kinetics and see big differences in the innate immune response between cell types.”

Children infected with SARS-CoV-2 rarely progress to respiratory failure, but the risk of mortality in infected people over the age of 85 remains high, despite vaccination and improving treatment options.

The research underscores the importance of considering age as a critical factor in both research and treatment of infectious diseases.

Co-senior author, Dr Marko Nikolic (UCL Division of Medicine), said: “It is fascinating that when we take away immune cells from nasal samples, and are only left with nasal epithelial cells grown in a dish, we are still able to identify age-specific differences in our body’s response to the SARS-CoV-2 between the young and elderly to explain why children are generally protected from severe COVID-19.”

Dr Smith added: “Understanding the cellular differences at the initiation of infection is just the beginning. We now hope to investigate the long-term implications of these cellular changes and test therapeutic interventions using our unique cell culture model. This ‘gold-standard’ system is only possible with the support of our funders and the willingness of participants to provide their samples.”

The team suggest that future research should consider how ageing impacts the body’s response to other viral infections.

Source: University College London

Categories : Diet and Nutrition PaediatricsTags :

Giving Fizzy Drinks to Toddlers Increases Adult Obesity Risk

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Consuming sugar-sweetened drinks in the first few years of childhood can be linked to poor diet patterns that increase the risk of obesity in later life, according to a new study by the School of Psychology at Swansea University.

Published in the European Journal of Clinical Nutrition, the study tracked the influence of diet on 14 000 British children from birth to adulthood and is believed to be the longest of its kind ever reported.

Using the Avon Longitudinal Study of Parents and Children, the research team found:

  • Children who drank fizzy drinks such as cola or sugar-sweetened fruit cordials before the age of two gained more weight when they were 24 years old. Girls who had pure fruit juice gained less weight, while the weight of boys remained the same.
  • At three years of age, toddlers who drank cola consumed more calories, fat, protein, and sugar but less fibre. In contrast, those given pure apple juice consumed less fat and sugar but higher amounts of fibre.

The study also highlighted corresponding differences in food choices.

Children who consumed pure apple juice often followed a diet with more fish, fruit, green vegetables, and salad, whereas those drinking cola ate more burgers, sausages, pizza, french fries, meat, chocolate, and sweets.

Additionally, the team discovered a link between sugar-sweetened drinks and social deprivation, with children from affluent backgrounds more likely to have access to pure fruit juice.

Lead researcher Professor David Benton said: “The early diet establishes a food pattern that influences, throughout life, whether weight increases. The important challenge is to ensure that a child develops a good dietary habit: one that offers less fat and sugar, although pure fruit juice, one of your five a day, adds vitamin C, potassium, folate, and plant polyphenols.”

Dr Hayley Young added: “Obesity is a serious health concern, one that increases the risk of many other conditions. Our study shows that the dietary causes of adult obesity begin in early childhood and that if we are to control it, more attention needs to be given to our diet in the first years of life.”

Source: Swansea University

Categories : Cancer Environmental EffectsTags :

Radon Gas Contributing to Rise in Lung Cancer among Young Adults

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Photo by Vladyslav Cherkasenko on Unsplash

Although lung cancer is traditionally thought of as a “smoker’s disease,” a surprising 15–20% of newly diagnosed lung cancers occur in people who have never smoked, many of whom are in their 40s or 50s.

This concerning rise in non-smoking lung cancer cases is likely linked to long-term, high exposures of radon gas. This colourless, odourless gas is emitted from the breakdown of radioactive material naturally occurring underground that then seeps through building foundations. The gas can linger and accumulate in people’s homes and lungs silently unless they know to test for it.

Although the U.S. Environmental Protection Agency (EPA) recommends regular radon testing and corrective measures to lower exposure levels in homes, a new consumer survey conducted on behalf of The Ohio State University Comprehensive Cancer Center (OSUCCC) showed that a stunning 75% of Americans have not had their homes tested for radon, and over half (55%) are not concerned about radon exposure in their homes, community or schools.

“Anyone with lungs can develop lung cancer, and as a community we should be aware and concerned about radon exposure because it’s thought to be one of the leading causes of lung cancer in never-smokers – and there is something we can do reduce our risk,” said David Carbone, MD, PhD, a thoracic medical oncologist. “There are relatively simple tests to measure radon in the home and actions to reduce radon exposure.”

This includes installing outside the home a radon remediation system that sucks air from the basement, where radon gas typically lingers. Increasing air flow by opening windows and using fans/venting in your home, and sealing cracks in the floors, walls and foundation is also important.

Lung cancer rising in young non-smokers

The No. 1 risk factor for lung cancer is long-term cigarette smoking; however, rates of lung cancer among non-smokers continue to rise. The symptoms of the disease are the same regardless of whether the person has smoked: generally not feeling well or feeling tired all the time, frequent cough, chest pain, wheezing, shortness of breath or coughing up blood. These symptoms happen with other illnesses too, but Carbone notes anyone – regardless of age – who has a lingering symptom that doesn’t resolve despite initial treatment should insist on having it checked out.

Lung cancer screening is currently available only to people at the highest risk for the disease – older adults with a history of heavy smoking.

If detected in its earliest stages, the cure rate for lung cancer can be 90–95%. The bulk of cases, however, are not detected until the disease has spread throughout the lung or to other parts of the body, when treatments aren’t as effective. It is important that anyone deemed at risk for lung cancer get timely screening, and that people who might be at increased risk due to secondhand smoke, radon or occupational exposures (like firefighting) talk to their doctors about testing.

“Your health and the health of your family are the most important things you have. Really push to get your concerns addressed if your symptoms aren’t resolving, even if you don’t fit the typical ‘picture’ of lung cancer. It could truly save your life,” said Carbone.

Requiring radon testing in homes, schools and workplaces

Carbone noted that having high levels of radon exposure at school or work is just as much a health hazard as having high-level exposure in your basement.

He says he strongly supports potential legislation to require radon testing at schools, at places of business and during home sales to help reduce community risk. The effects of radon on your lungs is cumulative and can be delayed by decades.

“So your children playing in your basement or going to school today, exposed to unknown levels of radon, could be at risk for developing lung cancer 10, 20, 30 years from now,” Carbone said. “And because the gas is totally colourless and odourless, you would have no idea you were being exposed unless you knew the importance of proactively testing.”

Source: Ohio State University Wexner Medical Center

Categories : Injury & TraumaTags :

Synthetic Platelets Stop Bleeding and Promote Healing in Animal Models

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Scanning electron micrograph of red blood cells, T cells (orange) and platelets (green). Source: Wikimedia CC0

Researchers have developed hydrogel-based synthetic platelets that can be used to stop bleeding and, in animal models, has been shown to enhance healing at an injury site. The research is presented in Science Translational Medicine.

A number of medical situations require platelet transfusions – such as cases of severe bleeding, or for patients who are going into surgery or receiving chemotherapy. Currently, patients in any of those situations receive platelets harvested from blood donors, ideally from donors with a compatible blood type. This is challenging, because there is a very limited supply of platelets available, those platelets have a limited shelf life, and the platelets must be stored under controlled conditions.

“We’ve developed synthetic platelets that can be used with patients of any blood type and are engineered to go directly to the site of injury and promote healing,” says Ashley Brown, corresponding author of a paper on the synthetic platelets and biomedical engineering programme. “The synthetic platelets are also easy to store and transport, making it possible to give the synthetic platelets to patients in clinical situations sooner – such as in an ambulance or on the battlefield.”

The synthetic platelets are made of hydrogel nanoparticles that mimic the size, shape and mechanical properties of human platelets. Hydrogels are water-based gels that are composed of water and a small proportion of polymer molecules.

“Our synthetic platelets are deformable – meaning they can change shape – in the same way that normal platelets are,” Brown explains.

The researchers engineered the surface of the synthetic platelets to incorporate antibody fragments that bind to a protein called fibrin. When a body is injured, it synthesises fibrin at the site of the wound. The fibrin then forms a mesh-like substance to promote clotting.

“Because the synthetic platelets are coated with these antibody fragments, the synthetic platelets travel freely through the blood stream until they reach the wound site,” Brown says. “Once there, the antibody fragments bind to the fibrin, and the synthetic platelets expedite the clotting process.”

In addition to forming a clot within the fibrin network, the synthetic platelets act to contract the clot over time – just like normal platelets.

“This expedites the process of healing, allowing the body to move forward with tissue repair and recovery,” Brown says.

The researchers initially demonstrated the efficacy of the antibody fragments via in vitro testing, as well as demonstrating that the antibody fragments and synthetic platelets could be produced at scales that would make them viable for large-scale manufacturing.

The researchers then used a mouse model to determine the optimal dose of synthetic platelets necessary to stop bleeding.

Subsequent research in both mouse and pig models demonstrated that the synthetic platelets travelled to the site of a wound, expedited clotting, did not cause any clotting problems in areas outside of the wound, and accelerated healing.

“In the mouse and pig models, healing rates were comparable in animals that received platelet transfusions and synthetic platelet transfusions,” Brown says. “And both groups fared better than animals that did not receive either transfusion. We also found that the animals in both mouse and pig models were able to safely clear the synthetic platelets over time through normal kidney function. We didn’t see any adverse health effects associated with the use of the synthetic platelets.

“In addition, based on our preliminary estimates, we anticipate that the cost of the synthetic platelets – if they are approved for clinical use – would be comparable to the current cost of platelets,” Brown says.

“We are wrapping up preclinical efficacy testing and are in the process of securing funding for preclinical safety work that should allow us to obtain FDA approval to begin clinical trials within two years.”

Source: North Carolina State University

Categories : GastrointestinalTags :

Deprescribing Efforts Shows that PPI Risks are Less than Expected

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Photo by Towfiqu Barbhuiya on Unsplash

Whether it’s costs, safety risks or “pill fatigue” they’re trying to reduce, many health systems and clinics have started working on ways to encourage deprescribing of medications that patients may not need. Now, a new study published in the BMJ shows the potential promise, and pitfalls, of a massive effort to reduce overuse of proton pump inhibitors (PPIs), widely prescribed for heartburn.

The findings also reveal that some of the feared risks from PPIs may be overblown.

The U.S. study tracks the impact of an intervention that imposed limits on PPI prescription size and refills for patients without a documented reason to be on the medication, discontinued old prescriptions, and provided education to patients and clinicians on alternatives.

The effort was carried out in one region of the Veterans Health Administration system, called VISN 17, and involved a quarter of a million patients, making it one of the largest ever studies on deprescribing.

Key findings

In all, the intervention led to a massive reduction in PPI use: a nearly 30% reduction in prescriptions of PPIs compared to other VA regions.

But the drive to reduce potentially unnecessary PPI use had one unintended consequence: a drop in prescribing to veterans who actually have an ongoing need to take PPIs because their other medicines carry a high risk of gastrointestinal bleeding. Strong evidence shows that PPIs are effective for preventing gastrointestinal bleeding and they are recommended in clinical guidelines.

Reassuringly, no matter the reason for taking PPIs, the deprescribing effort didn’t lead to increases in health care visits with gastrointestinal diagnoses. Nor did it lead to increases in gastrointestinal bleeding in patients at high risk, which suggests that the deprescribing initiative itself was safe.

Interestingly, the rate of purported negative PPI effects, such as kidney disease, stroke, heart attack or pneumonia, didn’t go down in VISN17 relative to the other regions. Hip fractures, another risk linked with PPIs in past studies, only went down by a small percentage.

This supports evidence from other high-quality studies that suggest PPIs may be a marker of patients at risk for certain adverse outcomes, but that the drugs are unlikely to be the cause.

For this reason, the main benefits to deprescribing PPIs have more to do with cost and hassle of taking more pills than clinical risk reduction.

More about the study

The new VA-funded study uses data from multiple years before and after VISN 17 implemented its PPI deprescribing program for most veterans living in Texas, and parts of New Mexico and Oklahoma.

It was led by a multi-institutional team that includes investigators from University of Michigan and the VA Center for Clinical Management Research (CCMR) in Ann Arbor; the University of Pennsylvania and the VA Center for Health Equity Research and Promotion (CHERP) in Philadelphia; and the Yale School of Medicine and VA Center for Pain Research, Informatics, Multi-morbidities, and Education (PRIME).

“This intervention worked so well because it was involuntary to some degree – refills could no longer be on autopilot for patients without a clear indication for the medication,” says Jacob Kurlander, MD, MS, first author of the study and a gastroenterologist at Michigan Medicine, U-M’s academic medical center, and the Lieutenant Colonel Charles S. Kettles VA Ann Arbor Medical Center. “At the same time, what we saw is that is that patients who benefit from PPIs for bleeding prevention – which is sometimes overlooked by doctors – got swept up in this effort, too.”

This signals that deprescribing efforts need to take even more care to ensure providers don’t allow a patient who has a need for the drug to inadvertently go off it, Kurlander said.

“Our findings also suggest that PPIs may not be as harmful as some have feared,” he adds.

Before the VISN 17 program started, about 26% of veterans across the country who got their primary care from a VA provider were prescribed a PPI in a six-month period.

By the end of the study period in 2019, only about 15% of veterans in VISN 17 had a PPI prescription, compared with about 22% of those in the other regions.

This means PPI prescribing dropped by 30% within VISN 17, and that there was more than a 7% absolute reduction in PPI use between VISN 17 and other regions by the end of the study period.

The researchers even connected veterans’ VA records with their Medicare data in case they received care outside the VA, and also used information from death certificates to look for causes of cardiovascular-related death. There were no differences between VISN 17 and the other regions.

Categories : Healthcare Politics and RegulationsTags :

SAHPRA Recalls Two Batches Of Benylin Paediatric Syrup

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Photo by cottonbro studio

On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup. SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing.

SAHPRA, in collaboration with Kenvue, have identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100 mL with a plastic measuring cup. It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.

SAHPRA wishes to inform the public not to panic as the matter is being handled with priority. Batch recalls are batch-specific and do not necessarily apply to other batches/similar products. The manufacturer is a SAHPRA-licenced manufacturer and complies with Good Manufacturing Practices. The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name.

SAHPRA is alerting healthcare professionals and the public to discontinue the use of the two batches mentioned, remove them from their inventory and return them to their normal distribution channel(s) with immediate effect.

Classification of the recalls

The recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a country-wide recall. The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.

What the public should know

Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.

Members of the public who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional and report this using the Med Safety App or send an email to: adr@sahpra.org.za.

The recall is limited to batch numbers 329304 and 329303 of Benylin Paediatric Syrup.

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Source: SAHPRA