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News Article
The FDA is still letting doctors implant untested devices into our bodies
Patient Safety Learning posted a news article in News
When Kathleen Yaremchuk, Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, began getting calls about mysterious cases of respiratory distress, she launched a study to figure out what was going on. All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death. The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and haemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80% of medical devices are cleared for sale in the United States. But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Read full story (paywalled) Source: The Washington Post, 4 January 2019 -
News Article
Patient harm versus medical malpractice: What US clinicians fear more
Patient Safety Learning posted a news article in News
Attending physicians and advanced practice clinicians in US emergency departments are more concerned about medical errors resulting in patient harm than in malpractice litigation, according to a study published JAMA Network Open. The findings are based on an online survey of 1,222 ED clinicians across acute care hospitals in Massachusetts from January to September 2020. Respondents used a Likert scale of 1 (strongly disagree) to 6 (strongly agree) to indicate their degree of agreement with statements on how fearful they are of making a mistake that leads to a patient harm in their day-to-day practice, and how fearful they are of an error that results in being sued. The mean score was greater for fear of harm (4.40) than fear of being sued (3.40), the findings showed. Researchers said the mean scores for both fear of harm and fear of suit were similar regardless of whether the survey was completed before or after onset of the COVID-19 pandemic. Although previous studies have associated clinicians' fear of legal concerns with "excessive healthcare use through defensive medicine," the role fear of patient harm may play in clinical decision-making is less documented, researchers said. "Although the study did not delineate the association between this concern and potential overuse of testing, it suggested that fear of harm should be considered with, and may be more consequential, than fear of suit in medical decision-making," researchers said. Read full story Source: Becker's Hospital Review, 21 November 2022 -
News Article
Oklahoma proposes landmark rule to keep mailed medications safe
Patient Safety Learning posted a news article in News
Patients in Oklahoma, USA, who get their prescription medications by mail may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts. “This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. “We’ve got a tremendous amount of prescriptions that get mailed to patients. … What we did today was make sure our patients in Oklahoma are receiving safe products.” Exposure to extreme temperatures can degrade or weaken drugs, potentially changing their dosage or chemical makeup and rendering them ineffective or unsafe for patients. But while government oversight of how pharmacies store medications to keep them in defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found oversight of shipping to patients — during which drugs might be exposed to heat waves and below-freezing temperatures — is largely a system of blind trust. Mail-order pharmacy is a booming business, with soaring profits for some of the nation’s largest companies last year and more than 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data. NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping. Read full story Source: NBC News, 17 November 2022 -
News ArticleAt a time when it feels like the world’s perpetually on fire, we all need a therapist – but trying to find one in the USA is difficult. A study from the American Psychological Association (APA) found that 6 in 10 psychologists “no longer have openings for new patients” in America. The shortage comes as demand for therapy soars: since the beginning of the pandemic, about three-quarters of practitioners have seen their waiting lists expand. In the same period, almost 80% of practitioners report an increase in patients with anxiety disorders and 66% have seen an increase in those needing treatment for depression. “I started my private practice just before Covid hit, and it was certainly filling up then,” says Dr Jennifer Reid, a psychiatrist, writer and podcast host in Philadelphia. “But the numbers have exponentially risen since that time.” Reid focuses on anxiety and insomnia, which have been “major players” in the pandemic. Early on, people with anxiety, phobias or obsessive-compulsive disorder related to germs had particular trouble, she says. Then there was the isolation and the doomscrolling. And now, she says, people are struggling to re-enter the world. “People are finding they’re having anxiety trying to re-engage in social settings in situations that were previously not as safe” at Covid’s peak, she says. Often, she says, people may need to return to their primary care doctor for a period of time, “or they just end up going without and waiting on waitlists, unfortunately”. The APA study found that the average psychologist reported being contacted by 15 potential patients every month; Reid, who combines therapy and medical approaches, says she generally has space for about one new patient every few weeks. Read full story Source: The Guardian, 21 November 2022
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News Article
USA: Address ‘plane-crash level’ patient harm, HHS tells hospitals
Patient Safety Learning posted a news article in News
Health and Human Services (HHS) Secretary Xavier Becerra startled a recent meeting of senior health system leaders by declaring in opening remarks that a plane crash had just killed all 200 passengers. He immediately added that this hadn’t really happened; he’d said it only to illustrate the toll taken by medical error. The 14 November meeting at which Becerra spoke signalled a renewed commitment by HHS to preventing patient harm as it launched an “Action Alliance to Advance Patient Safety.” The Alliance aims to recruit the nation’s largest health systems as participants. “We’re losing pretty much an airline full of Americans every day to medical error, but we don’t think about it,” said Becerra. (The department’s fiscal 2022-2026 strategic plan actually estimated the death toll at roughly 550 daily, which would be a very large airliner.) “But the worst part about it is that it’s avoidable.” Though the meeting rhetoric was rousing and the invitee list impressive, specifics remained scarce. The Alliance is described only in general terms as a partnership among health systems, federal agencies, patients and others to implement Safer Together: A National Action Plan to Advance Patient Safety. Read full story Source: Forbes, 17 November 2022 -
News Article
US Senate investigates ‘catastrophic failure’ to protect female migrant detainees
Patient Safety Learning posted a news article in News
A US Senate investigation into allegations that unwanted medical procedures were performed on detained female immigrants in Georgia has uncovered “a catastrophic failure by the federal government” to protect the detainees. A Senate hearing on Tuesday by the bipartisan permanent subcommittee on investigations (PSI), chaired by the Georgia senator Jon Ossoff, announced its findings on conditions and practices at the Irwin county detention center (ICDC). The ICDC, located in Ocilla, Georgia, housed detainees who shared accounts of poor treatment including gynaecological procedures that were “excessive, invasive and often unnecessary”. An account of what was occurring at the ICDC first came to light when Dawn Wooten, a nurse at the facility, acted as a whistleblower. Ossoff called the alleged unnecessary and sometimes non-consensual medical treatment and procedures disclosed in the 18-month investigation “nightmarish and disgraceful”. Ossoff said: “This is an extraordinarily disturbing finding, and in my view represents a catastrophic failure by the federal government to respect basic human rights.” The report detailed the harrowing account of an unnamed woman who was detained in the ICDC in 2020. The detainee describes how Dr Mahendra Amin allegedly removed a portion of her fallopian tube, a result of a dilation and curettage procedure she was not made aware of, and how Amin told her “she would never be able to have children naturally again”. Read full story Source: The Guardian, 15 November 2022 -
News Article
FDA warns of rise in reports of child poisonings linked to cough medicine
Patient Safety Learning posted a news article in News
Poison control centres in the USA have seen an increase in reports of children ingesting a type of prescription cough medicine, a study published by the Food and Drug Administration (FDA)found. From 2010 through 2018, reports of paediatric poisonings involving the drug, benzonatate, increased each year, the study found. Benzonatate, sold under the brand name Tessalon, is prescribed to treat coughs caused by colds or the flu. It is not approved for children younger than 10 years old. The findings, published in the journal Pediatrics, were based on more than 4,600 cases reported to poison control centres. The reports included children who were unintentionally exposed to the drug, as well as children who abused or misused it intentionally. The proportion of cases with serious adverse effects was low. However, accidental or inappropriate use of benzonatate, which comes in gel capsules, can lead to serious health problems in children, including convulsions, cardiac arrest and death. The findings should galvanise doctors to be more careful when they prescribe these kinds of medications, said study author Dr. Ivone Kim, a pediatrician and senior medical officer at the FDA. Cough medications "should be treated like any other medication that can have serious side effects," Ameenuddin said, "which means not giving it to children without specific medical direction." Read full story Source: NBC News, 15 November 2022 -
News Article
US nurse who called emergency services on own hospital speaks out
Patient Safety Learning posted a news article in News
A nurse in the USA who called emergency services in response to staffing issues at Silverdale, Washington-based St. Michael Medical Center spoke out about her decision and the events leading up to the call. Kelsay Irby has been an emergency department charge nurse at the hospital for less than a year. On the 8 October, the night Ms Irby called emergency services for help, the ED was operating at less than 50% of its ideal staffing grid. Among the nearly 50 people in the hospital's waiting room were patients with cardiac or respiratory issues and children with high fevers — "all patients that made us very nervous to have in the lobby, unmonitored for extended periods of time," Ms. Irby said. The ED had one first-look nurse on the clock who was trying to keep up with patients checking in and could not supervise those waiting for care. After exhausting all other available options, Ms. Irby said she called emergency services' nonemergent line and asked the dispatcher if any crews were available to help ED staff. Ms. Irby was connected with a local fire chief who sent an emergency services crew to the hospital to monitor patients in the lobby, retake their vitals and do roll calls to ensure the ED team's patient list was accurate. Ms. Irby's actions made national headlines in the US as a dramatic example of the staffing issues hospitals nationwide are facing. "I didn’t recognize the impact of what I was doing that night," Ms. Irby wrote. "I was simply working my way down the list of possible sources of help for my coworkers and ultimately our patients." Read full story Source: Becker's Hospital Review, 8 November 2022 -
News ArticleThirty-three provider groups in the USA penned a joint letter to President Joe Biden this week warning of “gridlocked” hospital emergency departments that are threatening patients’ lives and the well-being of shorthanded healthcare workers. “In recent months, hospital emergency departments (EDs) have been brought to a breaking point. Not from a novel problem—rather, from a decades-long, unresolved problem known as patient ‘boarding,’ where admitted patients are held in the ED when there are no inpatient beds available,” provider associations including the American College of Emergency Physicians (ACEP) and the American Medical Association (AMA) wrote. “While the causes of ED boarding are multifactorial, unprecedented and rising staffing shortages throughout the healthcare system have recently brought this issue to a crisis point.” The issue of boarding “has become its own public health emergency” for adult and paediatric care alike, the latter of which is being driven by a spike in mental health visits and, more recently, a “triple threat” of flu, COVID-19 and respiratory illnesses that have backed up children’s hospitals. “If the system is already this strained during our ‘new normal,’ how will emergency departments be able to cope with a sudden surge of patients from a natural disaster, school shooting, mass casualty traffic event or disease outbreak?” the groups wrote. The letter included a handful of firsthand accounts solicited by ACEP from anonymous emergency physicians describing patients deteriorating or dying “during their tenth, eleventh or even twelfth hour of waiting to be seen by a physician.” Read full story Source: Fierce Healthcare, 10 November 2022
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News Article
CDC releases new, more flexible guidelines for prescribing opioids
Patient Safety Learning posted a news article in News
Responding to a backlash from pain patients in the USA, the Centers for Disease Control and Prevention (CDC) have released updated guidelines that offer clinicians more flexibility in the way they prescribe opioids for short- and long-term pain. The new recommendations eliminate numerical dose limits and caps on length of treatment for chronic pain patients that had been suggested in the landmark 2016 version of the agency’s advice, which was aimed at curbing the liberal use of the medication and controlling a rampaging opioid epidemic. Those guidelines cautioned doctors that commencing opioid therapy was a momentous decision for patients. Parts of that nonbinding document were widely misinterpreted, resulting in unintended harm to patients who were benefiting from use of opioids without much risk of addiction. Patients reported they were rapidly tapered off medication by doctors or saw their medication abruptly discontinued, the CDC acknowledged in the new document. The new 100 pages of guidance — which remain only recommendations for doctors, nurse practitioners and others authorised to prescribe opioids — emphasize returning the focus to the caregiver and patient deciding on the best course of treatment. Read full story (paywalled) Source: The Washington Post, 3 November 2022 -
News Article
US hospital flu cases hit 10-year high as vaccinations fall
Patient Safety Learning posted a news article in News
US influenza hospital admissions have hit the highest rate in a decade as vaccinations sag, US officials say. They said adults have received five million fewer influenza jabs this year compared with the same time last year. Health experts are worried a so-called tripledemic of flu, respiratory syncytial virus (RSV) and coronavirus could swamp hospitals this winter. At least 730 people have died of flu this year, according to the Centers for Disease Control and Prevention (CDC). While older people are the most vulnerable age group, at least four children are among the dead. CDC data shows there have been at least 1.6 million flu cases overall and some 13,000 people have been taken to hospital. This season's severity has not been matched at this point in the year since the H1N1 swine flu pandemic hit the US in 2009. "There's no doubt we will face some challenges this winter," Dawn O'Connell, the US Department of Health and Human Services' (HHS) assistant secretary for preparedness and response, said at a media briefing on Friday. Read full story Source: BBC News, 5 November 2022 -
Content ArticleAlthough serious medication errors are uncommon, their effects can be devastating for patients and their loved ones. The authors of this study in the journal Patient Safety searched the Pennsylvania Patient Safety Reporting System (PA-PSRS) for reports of serious medication errors in the emergency department from 1 January 2011 to 31 December 2020. They identified trends in the data, looking at patient sex, patient age, event harm score, event day of the week and event time of day. The authors found that: error reports more often specified that the patient was female. events were significantly more likely to happen over the weekend. most errors occurred at the prescribing stage. the most common error type was a wrong dose. They conclude that a number of patient safety strategies could reduce the risk of medication errors in the emergency department, including: stocking epinephrine autoinjectors. using clinical decision support at the ordering/prescribing stage of the process. adding an emergency medicine pharmacist to interdisciplinary emergency medicine teams.
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Content ArticleDisease-modifying antirheumatic drugs (DMARDs) are a group of medications commonly used in people with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and systemic lupus erythematosus (SLE). They work by work suppressing the body's overactive immune and/or inflammatory systems and take effect over weeks or months. This information guide gives information for patients on conventional and biologic DMARDS, including how they work, the different kinds available and their side effects.
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Content ArticleIn 2016, the Centers for Disease Control and Prevention published prescribing guidelines for opioids. Though intended to encourage best practices in opioid prescribing, these guidelines fueled providers’ fears of opioids and led to many clinicians abandoning patients who relied on opioids for pain relief. In this article, Antje M. Barreveld reflects on the harms he may have caused by underprescribing these drugs, not overprescribing them.
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Content ArticleThis article in the journal Patient Safety describes a state-wide, population-based study into tracheostomy- and laryngectomy-related airway safety events. The Pennsylvania-based study aimed to assess the relationship of these events with associated factors, interventions and outcomes, to identify potential areas for improvement. The authors queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) to find tracheostomy- and laryngectomy-related airway safety event reports involving adults age 18 years and older that occurred between 1 January 2018, and 31 December 2020.
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Content ArticlePreventable harm continues to occur to critically ill premature babies, despite efforts by hospital neonatal intensive care units (NICUs) to improve processes and reduce harm. This article in the Journal for Healthcare Quality describes the introduction of a robust process improvement (RPI) program at a NICU in a US children's hospital. Leaders, staff, and parents were trained in RPI concepts and tools and given regular mentoring for their improvement initiatives, which focused on central line blood stream infections, very low birth weight infant nutrition and unplanned extubations. The authors conclude that implementing the RPI program resulted in significant and sustainable improvements to reduce harm in the NICU.
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Content ArticleRemote, at-home patient monitoring was widely used during the Covid-19 pandemic due to lack of hospital beds. This article in JAMA Network looks at the benefits of remote monitoring and how it can be used safely. Studies have shown that the use of remote telemonitoring reduced length of hospitalisation for Covid patients requiring oxygen, and the number of patient visits to emergency departments. The authors look at how the combined use of telehealth, home health and remote monitoring could bring hospital-level–monitoring services to patients in their home, and what barriers need to be overcome to achieve this.
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Content ArticleHuge numbers of patients suffer avoidable harm in US hospitals each year as a result of unsafe care. In this blog, published in the Harvard Business Review, the authors argue that these numbers could be greatly reduced by taking four actions: Make patient safety a top priority in hospitals’ practices and cultures, establish a National Patient Safety Board, create a national patient and staff reporting mechanism, and turn on EHRs machine learning systems that can alert staff to risky conditions.
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Content ArticleAn increasing number of cancer patients are using the internet to better understand their disease and connect with others facing the same challenges. Online cancer communities have developed into resources that highlight new research and evolving treatments. Combined with increasing health literacy and social media, they have enabled some patients to become experts in their cancer. This article in the journal JCO Oncology Practice examines the role of expert patients (e-patients) in advancing cancer medicine, and looks at opportunities available to those who wish to become more involved in research advocacy. The authors found that e-patients play a greater role in their own care and in larger conversations regarding practice, research, and policy. They highlight that clinicians can engage e-patients as partners in cancer care to work together towards improving healthcare access and outcomes for people with cancer.
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Content ArticleRaDonda Leanne Vaught faced criminal charges over a fatal medication error she made in 2017. Her trial has raised important questions over medical errors, reporting and process improvement, as well as who bears responsibility for widespread use of tech overrides in hospitals. There is debate over whether automated dispensing cabinet overrides are a reckless act or institutionalised as ordinary given the widespread use of IT workarounds among healthcare professionals. The Nashville District Attorney's Office described this override as a reckless act and a foundation for Ms. Vaught's reckless homicide charge, while some experts have said cabinet overrides are used daily at many hospitals.
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Content ArticlePrimary care is a crucial part of every healthcare system, but the US spends less on primary care and more on specialty care than other high-income countries. The results of this are burnout, high staff turnover and physician shortages. These were all major problems before Covid-19, that have been worsened by the pandemic. In this episode of The Commonwealth Foundation's podcast The Dose, host Shanoor Seervai asks Asaf Bitton, MD, executive director of the health innovation center at Ariadne Labs, what it will take to rebuild the USA's broken primary care system.
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Content ArticleThis study in the Journal of Patient Safety aimed to describe the contributing factors in diagnosis-related and failure-to-monitor malpractice claims in which nurses are named the primary responsible party. It also aimed to identify actions healthcare leaders can take to enhance the role of nurses in diagnosis. The authors found that as nurses are held legally accountable for their role in diagnosis, leaders need to raise awareness across the system of the roles and responsibilities of nurses in this area. They also need to focus on enhancing nurses' diagnostic skills and knowledge.
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Content ArticlePrimary care providers (PCPs) serve as most people’s first point of contact with the healthcare system. These clinicians build relationships with their patients over time and help coordinate care delivered by other health care providers. Evidence shows that a strong foundation of primary care yields better health outcomes overall, greater equity in health care access and outcomes, and lower per capita health costs. But in the United States, decades of underinvestment and a low provider supply, among other problems, have limited access to effective primary care. This Commonwealth Fund brief highlights gaps in the US primary care system by comparing its performance to systems in 10 other high-income countries.
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Content ArticleThis article in The Journal of Post-Acute and Long-Term Care Medicine looks at the issue of systemic racism in long-term services and supports (LTSS) including nursing homes and home- and community-based care in the USA. The authors highlight segregation and disparities, with Black, Indigenous, and persons of colour (BIPOC) users having less access to quality care and reporting poorer quality of life. The authors make a number of policy recommendations to address these health inequalities in LTSS: Targeted increases to Medicaid reimbursement tied to direct care, and targeted enhanced Medicare and/or Medicaid reimbursement to LTSS providers that serve a disproportionate share of Medicaid or underserved older adults. Pay for performance incentives should focus on improving care among LTSS providers who serve individuals with disadvantaged status because of systemic racism and that operate above and beyond a person's clinical severity and comorbidity. The Centers for Medicare & Medicaid Services (CMS) should develop an overall health equity measure which would help capture how well providers meet the needs of diverse populations. Care Compare quality scores by race and ethnicity should be used internally and shared with states to develop culturally appropriate policies. Race and ethnicity-specific quality measures should be included on state-level report cards to incentivise action among states and tailor solutions to the local context. Promote culture change in nursing homes, with an ultimate goal of creating a person-centred, homelike model of care. Expand access to Medicaid-waivered home- and community-based services. Ensure that home- and community-based services are culturally appropriate. Promote integrated home- and community-based programs that can be targeted to BIPOC users to address existing disparities in outcomes.
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Content ArticleThis article in the journal JAMA Network Open aimed to determine if the Agency for Healthcare Research and Quality (AHRQ) Safety Program for Improving Antibiotic Use, an educational initiative to establish antibiotic stewardship programs focusing on patient safety, is associated with reductions in antibiotic use in long term care settings. The authors looked at 439 long term care settings and found that participation in training on antibiotic stewardship from AHRQ was associated with a reduction in antibiotic use and urine culture collection. Fluoroquinolones, an antibiotic class targeted by the AHRQ safety program, had the greatest decrease.
