viernes, 21 de junio de 2024
Exceptional Genetics, Generalizable Therapeutics, and Coronary Artery Disease (Posted May 30, 2024 0PM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=pgx&query=home
From the article: "The increasingly widespread availability of genomic sequencing has enabled the identification of persons and families with uniquely favorable traits, including a very low incidence of clinical events. Such exceptional persons across diverse communities are playing an important role in the genesis of medicines for common cardiovascular diseases. "
Implementation research: an approach to overcoming the know-do gap (Posted Jun 15, 2024 8AM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=Implementation&query=home
From the article: " Many people who could benefit from evidence-based treatments do not receive them; a circumstance that is sometimes referred to as the know-do gap. We know the interventions that can be beneficial, but we do not know how to do those interventions in real-world settings. The gap can be particularly large if influenced adversely by social determinants of health. Implementation research seeks to produce evidence to reduce the know-do gap."
Improving Noninvasive Colorectal Cancer Screening. John M Carethers et al. N Engl J Med 2024 3 (11) 1045-1046 (Posted Mar 14, 2024 10AM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=economic&query=home
From the article: "Screening for colorectal cancer saves lives. Screening tests have evolved to include stool-based, endoscopic and image-based, and blood-based methods, with minimal thresholds for sensitivity and specificity for colorectal cancer set by the baseline characteristics of FIT. Although multiple tests have been developed over time and vary in cost-effectiveness for colorectal cancer screening, the best screening test is the one that gets completed by the patient. Most of the recommended tests, including the two newer tests assessed in the studies now published in the Journal, improve on the sensitivity and approach the specificity of FIT. "
Implications of Provider Specialty, Test Type, and Demographic Factors on Genetic Testing Outcomes for Patients with Autism Spectrum Disorder (Posted Jun 18, 2024 4PM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=equity&query=home
From the abstract: "A minority of patients with autism spectrum disorder (ASD) are offered genetic testing by their providers or referred for genetics evaluation despite published guidelines and consensus statements supporting genetics-informed care for this population. This study aimed to investigate the ordering habits of providers of different specialties and to additionally assess the diagnostic utility of genetic testing by test type, patient sex, and race and ethnicity. "
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry JUNE 2024
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-development-oligonucleotide-therapeutics?utm_medium=email&utm_source=govdelivery
On June 17, 2024, the FDA announced the availability of a final guidance for industry entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics, replacing the June 2022 draft guidance on this topic.
Oligonucleotide therapeutics are an emerging therapeutic modality with increasing numbers of drugs in development. Oligonucleotide therapeutics include a wide variety of synthetically modified RNA or RNA/DNA hybrids that are specifically designed to bind to a target RNA sequence to alter RNA expression and/or downstream protein expression. Many antisense and small interfering RNA (siRNA) oligonucleotide therapeutics have been FDA-approved in recent years. In addition, increasing numbers of oligonucleotide therapeutics are currently in development. Oligonucleotide therapeutics have unique characteristics compared to small molecule drugs or biological products (e.g., chemistry, structure, sites of action, pharmacokinetic disposition, pharmacodynamics). Therefore, several factors should be considered in determining which studies are needed to characterize the clinical pharmacology of these products.
This final guidance provides the FDA’s recommendations to assist industry in the development of oligonucleotide therapeutics. Specifically, it provides the FDA’s recommendations for certain evaluations during development of oligonucleotide therapeutics, including: (1) characterizing the potential for QTc interval prolongation, (2) performing immunogenicity risk assessment, (3) characterizing the impact of hepatic and renal impairment, and (4) assessing the potential for drug-drug interactions. This guidance also provides recommendations on when to conduct these assessments and what types of assessments are suitable to address the topics listed above.
FDA updates guidance on interchangeability
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-guidance-interchangeability?utm_medium=email&utm_source=govdelivery
This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.
Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session; July 25, 2024 JULY 25, 2024
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/virtual-public-meeting-home-health-care-hub-stakeholder-listening-session-july-25-2024-07252024?utm_medium=email&utm_source=govdelivery
The U.S. Food and Drug Administration (FDA) continues to advance the Home as a Health Care Hub initiative with new ways to share progress, answer questions, and receive feedback from stakeholders.
Today, the FDA is announcing a new web page and virtual public meeting dedicated to this health equity initiative.
The new web page offers more detail about the initiative’s goals and background. It answers frequently asked questions, and it’s where we’ll share our progress.
A virtual public meeting on the initiative will provide information, seek input from stakeholders, and start a dialogue about barriers and opportunities associated with making the home part of the health care system.
Important information for the virtual public meeting:
Date: July 25, 2024
Time: 12:00 p.m. to 4:00 p.m. ET
Registration deadline: July 25, 2024, at 11 a.m. ET
To speak at the virtual public meeting: express your interest by noon, July 12, 2024, following the instructions on the meeting web page.
jueves, 20 de junio de 2024
Anesthesia-related closed claims in free-standing ambulatory surgery centers. June 19, 2024
https://psnet.ahrq.gov/issue/anesthesia-related-closed-claims-free-standing-ambulatory-surgery-centers
Anesthesia-related closed claims in free-standing ambulatory surgery centers.
Pimentel MPT, Chung S, Ross JM, et al. Anesth Analg. 2024;Epub Apr 19.
An increasing proportion of surgeries are performed in freestanding ambulatory surgery centers (ASCs) rather than in hospitals. This study examined closed anesthesia-related malpractice claims of ASCs and hospital-based operating rooms (HORs) to examine any differences in severity of injury, major injuries, allegations, comorbidities, contributing factors, and financial value of the claim. The most common type of injury in both ASC and HOR was dental injury followed by nerve damage. Claims with higher severity of injury were less frequent in ASCs compared to HORs, but patient burns and poor communication between patients and providers were more frequent issues among ASC claims.
Incidence of drug-related adverse events related to the use of high-alert drugs: a systematic review of randomized controlled trials. June 19, 2024
https://psnet.ahrq.gov/issue/incidence-drug-related-adverse-events-related-use-high-alert-drugs-systematic-review
Incidence of drug-related adverse events related to the use of high-alert drugs: a systematic review of randomized controlled trials.
Menezes MS, Doria GAA, Valença-Feitosa F, et al. Explor Res Clin Social Pharm. 2024;14:100435.
High-risk medications are classified as such due to their narrow therapeutic range and potential for serious adverse drug events (ADE). This review analyzes the results of randomized clinical trials to identify effective interventions to reduce ADE related to high-risk medications in hospitals. The most cited medications were warfarin, cyclophosphamide, and cyclosporine. The most common intervention was developing protocols for safe use.
Interventions to prevent falls in older adults: updated evidence report and systematic review for the US Preventive Services Task Force. June 19, 2024
https://psnet.ahrq.gov/issue/interventions-prevent-falls-older-adults-updated-evidence-report-and-systematic-review-us
Interventions to prevent falls in older adults: updated evidence report and systematic review for the US Preventive Services Task Force.
Guirguis-Blake JM, Perdue LA, Coppola EL, et al. JAMA. 2024;Epub Jun 4.
Falls are a leading cause of injury and death in adults aged 65 years and older, and prevention is a public health and patient safety priority. This review of interventions to prevent falls in community-dwelling older adults was conducted for the US Preventative Services Task Force (USPSTF). Multifactorial and exercise interventions were associated with reduced falls, with exercise interventions demonstrating the most consistent benefit.
Bridging the Gap In Neuroscience & African Ancestry America’s First African Ancestry Neuroscience Research Initiative
https://aanri.org/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9E6RsjkbCNPt60rPlnxd8QyBA94bOFYHcoc_wjY3diVxXvn4ZEIWfpcN0ygee0mcDXAh7htPUrcpDnvTn8arQSgN8YbA&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
New research aims to close the racial gap in neuroscience data
In neuroscience research, data is typically dominated by participants with European descent. This limits the potential for researchers to investigate disparities in neurological diseases — Black Americans are 20% more likely to experience major mental health problems, and twice as likely to develop Alzheimer’s disease. But one new study is making strides to change that.
More than 100 Black people in Baltimore donated the brains of their deceased loved ones for the study, published in Nature Neuroscience last month. It’s the first major undertaking from the African Ancestry Neuroscience Research Initiative — a collaboration between the Lieber Institute for Brain Development, local community leaders, and Morgan State University, a historically Black research university in the city. The study’s findings could have implications for future personalized therapies informed by genetic ancestry. Read more on what researchers learned from STAT’s Alia Sajani.
https://www.statnews.com/?p=1171741&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8_fSdZtpF1kRbyXaDeryBtcOEWyxVuLV7PmZMTM96lvTvO8H0rKS-9BYEdM9B9I_NmYy3x_JR7zyDCsrRrltEF3RGosQ&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
Why haven’t journals retracted ‘research’ from Richard Lynn?
https://www.statnews.com/?p=1167931&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--K2EPLWFNCf_6-jRVUXZ6oaXTAs9C5H1m08zpjoWkd1sS-xQAwy6ZCowXNDi7hwdR8W1lJ10Zv6QWp_5RxkRIv_qmmsQ&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
The researcher Richard Lynn died in 2023, but his work continues to be cited today; Google Scholar reports more than 22,000 citations, with almost 4,500 of them coming after 2019. The last article he co-authored in a mainstream journal was published early in the year he died, and a posthumously published article recently appeared in a fringe journal.
What did he research, you ask? For decades, Lynn was one of the loudest proponents of the unfounded idea that Western civilization is threatened by “inferior races” that are genetically predisposed to low intelligence, violence, and criminality. His work has been repeatedly condemned by social scientists and biologists for using flawed methodology and deceptively collated data to support racism.
But despite decades of criticism of the poor quality and practices of his work, only a few journals have taken any action to retract his papers or even acknowledge the criticism. Read more in a new First Opinion essay about the legacy of his work.
Journals that published Richard Lynn’s racist ‘research’ articles should retract them Richard Lynn's work, especially his "national IQ" data, has been condemned as seriously flawed. It's time to retract these racist studies. By Dan Samorodnitsky, Kevin Bird, Jedidiah Carlson, James Lingford, Jon Phillips, Rebecca Sear, and Cathryn Townsend
https://www.statnews.com/?p=1171742&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9FaD_sNZkWDfLwvIt_IzyMwATL1_q28am3w5WD-SXwsg4U7-kgzu2sph9r0ZMPeZ17mgLCNaVmiOjhCf7lUDYiqw5Hhg&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
Addiction experts are sounding the alarm on a potential new crisis: gambling
A casino on the Las Vegas strip may have been an odd choice for a conference about treating opioid addiction. But it came with a silver lining: An opportunity for addiction experts to sound the alarm about the proliferation of online sports betting and, more broadly, the intersection of gambling and substance use disorders.
Drug counselors might be ill-equipped to help patients who present with concerning gambling behavior alongside a substance use disorder, one presenter said. Many will need to get up to speed quickly: Americans bet nearly $120 billion on sports in 2023, and the link between gambling and suicidality is well-documented. But the field is working to adapt, and a select few lawmakers are working to step in and regulate an industry that Rep. Paul Tonko (D-N.Y.) suggested could quickly turn into a “Wild West.
ABORTION Abortion pills, abortion laws, abortion rights — the landscape of reproductive rights swiftly changed when the Supreme Court overturned Roe v. Wade with the Dobbs v. Jackson Women’s Health decision.
https://www.statnews.com/topic/abortion/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-98dtiKRSxk6icJohjljjfqhlxVnA_dTVbBjPcdFhsvDOYKXafpJ3bsk5Oo25ildGE0FM0ve7S7GE6pm7O7kZH7NXJcOQ&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
Abortion is on the ballot this November
Two years after the Supreme Court overturned Roe v. Wade and less than five months before the general presidential election, abortion is still a major political issue for voters. But its relative importance depends on age, partisanship, and state dynamics, according to new results from the KFF Survey of Women Voters.
One in 10 women voters in the survey say that abortion is the most important issue for their vote this November. In the past, abortion has been more important to Republicans than Democrats, but that dynamic has reversed post-Roe, especially for Democrats living in states with abortion restrictions. Democrats living in these states also say they’re more motivated to vote in this year’s election, compared to those in states where reproductive rights are not on the ballot.
https://www.kff.org/womens-health-policy/poll-finding/kff-survey-of-women-voters-key-takeaways/
To treat obesity in children, task force favors behavioral therapy over drugs like Wegovy Elizabeth Cooney By Elizabeth Cooney June 18, 2024v
To treat obesity in children, task force favors behavioral therapy over drugs like Wegovy
Elizabeth Cooney
By Elizabeth Cooney June 18, 2024
https://www.statnews.com/2024/06/18/children-obesity-behavioral-therapy-wegovy-recommendations/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--ZhIOYXlNDm6tlfsnx1R9K79LovDoXbtEMaS7u_c7xs_6yqJz9l2C6WR-IkD9dNxNVE2gcXOWnUwR0F866_wwr0Uh9sA&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
Doctors debating whether to prescribe obesity drugs for children whose weight tops growth charts now have two camps to choose from: the American Academy of Pediatrics, which got pushback last year when it advised considering obesity drugs for kids 12 and older with high BMI, and the U.S. Preventive Services Task Force, which landed yesterday on behavioral interventions to help children 6 and older with high BMI (itself a controversial measure). Both groups encourage better nutrition, physical activity, and behavioral therapy from age 6, which can be hard to find.
Why such dissonance? The task force cited “inadequate” evidence on obesity drugs. AAP’s Sarah Armstrong, a Duke professor of pediatrics, cited the “P,” for preventive, in the task force's name. “The USPSTF really focuses on interventions clinicians can initiate for long-term prevention of chronic disease,” she told STAT. “We’re looking at the here and now: What do we need to treat obesity?”
‘That scares me’: New childhood obesity guidelines still face a long road to consensus
Isabella Cueto
Theresa Gaffney
By Isabella Cueto and Theresa Gaffney
https://www.statnews.com/2023/03/20/childhood-obesity-guidelines-eating-disorders-data-concerns/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9y52pL6xOSDCUtB6gB2jGA6fjKv-tMD7zIYZEmtMNaeI-zz6EwzLJIg-O0auUnJ3nY7E6w_m_YgwEXsVGo8jdeQolsGg&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
March 20, 2023
Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity
https://publications.aap.org/pediatrics/article/151/2/e2022060640/190443/Clinical-Practice-Guideline-for-the-Evaluation-and?autologincheck=redirected&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_oYFzoOX7Y6uPZoOX1surbwSpHo9hUtoffZZUggp10LMigZhSIzDUHp14qtdgWaaZnbgjHynVKvCsu7HKWngLqnfWP2A&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
For a 9-year-old patient at a Los Angeles obesity clinic, barriers to health are everywhere
Isabella Cueto
By Isabella Cueto
https://www.statnews.com/2023/07/17/healthy-weight-clinic-children-obesity-barriers/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-86DARqDUTbrlqJMpe7JBMWWPEgGsp4riFB3aJjjAYrgA52Qf7hGYT6g9DVdY7SlOzeH2cd5v8ZPcNoZ5lCSNmqUAT0aQ&_hsmi=312191336&utm_content=312191336&utm_source=hs_email
July 17, 2023
miércoles, 19 de junio de 2024
The burden of knowledge The Lancet Planetary Health
https://www.thelancet.com/journals/lanplh/issue/vol8no6/PIIS2542-5196(24)X0007-8
A systematic evaluation of seven different scores representing the EAT–Lancet reference diet and mortality, stroke, and greenhouse gas emissions in three cohorts
https://www.thelancet.com/journals/lanplh/article/PIIS2542-5196(24)00094-9/fulltext?dgcid=hubspot_update_feature_updatealerts_lanplh&utm_campaign=update-lanplh&utm_medium=email&_hsenc=p2ANqtz-8HfMk3FYhyb7vyINKoyV4LeE8iCkMSB2sFx8zuAUmdEWPdDb81h2r1_c0-5RPyaatOfravkhstWxJNiA9I4y3unPygxQ&_hsmi=312143855&utm_content=312105079&utm_source=hs_email
CAHPS Mental Health Surveys
CAHPS Mental Health Surveys: The CAHPS Outpatient Mental Health Survey asks adult patients about experiences with mental health and substance abuse services received in any outpatient setting. The CAHPS research team developed this instrument in response to changes in the ways these services are provided and as a replacement for CAHPS ECHO Survey.
AHRQ Releases Outpatient Mental Health Survey
https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/mhs/cahps-outpatient-mental-health-survey-adult-english.pdf
AHRQ’s Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program recently released the Outpatient Mental Health Survey. The survey is a standardized instrument that asks adult patients about their experiences receiving mental health and substance abuse services in any outpatient setting within the past 6 months.
This survey was developed by the CAHPS research team in response to changes in the way mental health and substance abuse services are provided. Potential users of this survey include mental health providers, medical groups, hospitals, health systems, health plans, healthcare monitoring organizations, and state agencies. Questions contained within the Outpatient Mental Health Survey focus on experiences with treatment and counseling services – including getting help between appointments and potential barriers to care. Additionally, demographic questions include an option for respondents to indicate their gender identity.
AHRQ Challenge on Designing the Optimal Future State of CDS Connect
AHRQ Challenge on Designing the Optimal Future State of CDS Connect: The winners of the CDS Connect Challenge are announced.
What is MyHealthfinder? Trusted information to help your family stay healthy.
https://health.gov/myhealthfinder
A new coalition of public and private health organizations, including AHRQ, has launched a campaign to promote the availability of no-cost preventive services under the Affordable Care Act. The Promoting Health Through Prevention campaign will use HHS’ Office of Disease Prevention and Health Promotion’s MyHealthfinder and other communications channels to highlight the importance of screenings for cancer, behavioral health conditions, heart disease and other preventive services. Additional participating organizations include AHIP, the American Academy of Family Physicians, the Blue Cross Blue Shield Association, the Centers for Disease Control and Prevention, Cigna Healthcare, Elevance Health, Florida Blue, Highmark Health, Humana, Kaiser Permanente, Mental Health America, the National Alliance of Healthcare Purchaser Coalitions, National Association of Community Health Centers, NCQA, Quartz Health Solutions and the VBID Center at the University of Michigan.
Webinar Series: Strengthening Primary Care Research
Webinar Series: Strengthening Primary Care Research: This series of webinars focuses on how to strengthen AHRQ’s primary research. For recordings of the presentations and slides, reference the webinars.
TeamSTEPPS 3.0
TeamSTEPPS 3.0: TeamSTEPPS is an evidence-based set of teamwork tools, aimed at optimizing patient outcomes by improving communication and teamwork skills among health care professionals. The training provides guides, videos, and exercises to practice the skills.
Surveys on Patient Safety Culture (SOPS)
Surveys on Patient Safety Culture (SOPS): Explore AHRQ's Surveys on Patient Safety Culture™ (SOPS®) surveys and supplemental items designed to capture provider and staff perceptions of patient safety culture in their organization.
Enhancing Surgical Team Communication: SOPS® and TeamSTEPPS® in Action (Webcast)
Enhancing Surgical Team Communication: SOPS® and TeamSTEPPS® in Action (Webcast): This webcast will provide background on AHRQ’s Surveys on Patient Safety Culture® (SOPS®) program, the TeamSTEPPS 3.0 team training curriculum, and how the use of TeamSTEPPS improves SOPS scores.
Registration is open for a webinar on July 25 at 1 p.m. ET on using the AHRQ Surveys on Patient Safety Culture® (SOPS®) Hospital Survey and TeamSTEPPS® resources to improve patient safety culture and surgical team communication. The SOPS Program helps healthcare organizations understand, measure and improve patient safety culture in healthcare settings. TeamSTEPPS provides evidence-based tools to optimize patient outcomes by improving communication and teamwork skills among healthcare teams, patients and family caregivers. The webinar will highlight how the University of North Carolina Department of Surgery used the AHRQ resources to improve patient safety culture and team communication.
Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review Monitoring Editor: Tiffany Leung Reviewed by Jennifer Wolff and Yuanchia ChuMobile Health Apps, Family Caregivers, and Care Planning: Scoping Review Monitoring Editor: Tiffany Leung Reviewed by Jennifer Wolff and Yuanchia Chu
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11157180/
Family caregivers who assist people living with multiple chronic conditions often lack sufficient support, but caregiver apps can help by enhancing care coordination and planning among patients, caregivers and clinicians, according to a scoping review in the Journal of Medical Internet Research. The research, authored by AHRQ researchers and other experts, identified important caregiver needs for information, support and care coordination for caregiving and self-care as well as desired app functionalities and features. Findings can inform developers and researchers in the design and implementation of mHealth apps to improve communication and outcomes of care. More research is needed to address the lack of studies about the specific needs of caregivers of people living with multiple chronic conditions, researchers asserted.
AHRQ Stats: Adverse Drug Events Involving Hypoglycemic Agents
https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/chartbooks/patientsafety/2023qdr-patient-safety-chartbook-final.pdf#page=71
In 2021, 7.5 percent of Hispanic patients, 6.6 percent of Black patients, 6.2 percent of patients with an “other” or unknown race, and 4.0 percent of White patients experienced adverse inpatient events involving hypoglycemic agents, which are used to control blood sugar levels in diabetic patients. (Source: AHRQ 2024
Space Station Research Advances NASA’s Plans to Explore the Moon, Mars
https://www.nasa.gov/missions/station/iss-research/space-station-research-advances-nasas-plans-to-explore-the-moon-mars/
Some of the challenges on missions to explore the Moon and Mars include preventing microbial contamination of these destinations, navigating there safely, protecting crew members and hardware from radiation, and maintaining and repairing equipment.
Research on the space station is helping NASA scientists develop tools and processes to ensure success on these important missions.
martes, 18 de junio de 2024
Introduction to FDA’s Office of Trade and Global Partnerships JULY 23, 2024
https://www.fda.gov/drugs/news-events-human-drugs/introduction-fdas-office-trade-and-global-partnerships-07232024?utm_medium=email&utm_source=govdelivery
The goal of this webinar is to provide an introduction to FDA’s Office of Trade and Global Partnerships (OTGP). OTGP serves as the FDA lead for addressing issues related to international trade of regulated products, mutual recognition agreements, and entering into arrangements and sharing information with global counterparts. OTGP also serves as the FDA lead for addressing cross-cutting issues in multilateral organizations, such as the World Health Organization, and coordinates issues arising in multilateral forums within FDA.
Through the webinar, the audience will learn how OTGP’s work relates to pharmaceutical products and understand the different types of international agreements and arrangements used by FDA. The audience will also learn when and how to contact OTGP.
Health Insurance Coverage: Estimates from the National Health Interview Survey
https://www.cdc.gov/nchs/nhis/healthinsurancecoverage.htm?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_kpzYcfc7YHO3S4jKhUw2hhYXlUSfPKktglGPrFod_xZjA1hyGtpUADCvgcIas1pG-RAW7MdUNr_p6lIE_IUvFig3BwQ&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Do you have a landline phone? If so, you may be healthier than me
In the second half of last year, 76% of adults and 87% of children lived in homes that did not have a landline telephone, but did have at least one cell phone. For 17 years, the National Center for Health Statistics has regularly released data on the proportion of people with landline phones versus wireless phones — a ratio that has practically flipped on its head over the decades. And in case you were wondering, this is relevant to health. As recently as 2018, NCHS data has shown that people who live in wireless-only homes are less likely to have health insurance or a regular place to go for medical care, and are more likely to face financial barriers to care.
It’s another sign that health is inexplicably linked to access to technology. Earlier this month, a federal program to provide people with a discount on a computer and monthly internet expenses ended because funding ran out. In anticipation of this exact scenario, STAT published a First Opinion essay last year from three clinicians and researchers about the real life effects that a lack of internet access can have on patients.
https://www.statnews.com/2023/07/20/acp-internet-access-health-care/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8I4o_QWv9jje9o_72s0zwoPjF15POeVoT5x9LUMSlK1H0vnGrc4U5sXlx30kaFInOxCxteqA2hn1VClGiQVk5jmYdr2g&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Long Covid feels like a gun to my head By Rachel Hall-CliffordJune 18, 2024
https://www.statnews.com/2024/06/18/long-covid-infectious-disease-expert-personal-story-life-with-no-cure/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9NFKdgcs2pndGeiShj6LJ__XeZFbU9k9fIGIWlH5ctpBMVc5mwmtA7Bh_k51wh1oKaInpLlWhNfJmTupIrdQLFS5cCLg&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Rachel Hall-Clifford has spent her career studying neglected tropical diseases. But in 2022, she got Covid for the first time, and now she has her own neglected disease: long Covid. Hall-Clifford is not easily intimidated — she once talked a Guatemalan street gang out of harming her research team as someone held an assault rifle to their heads during a robbery. But in a new First Opinion essay, she admits that long Covid scares her like nothing else.
“This is not a funny story I will tell colleagues over drinks later,” she writes. “I spend a lot of my time lying in the dark (I’m here now, even as I type this) negotiating with god and science to make me — and all of us suffering with long Covid and other post-viral illnesses — better.” Read the essay, and watch out for an interview with Hall-Clifford on the First Opinion Podcast tomorrow.
https://open.spotify.com/show/3y7p5nBy5fRV5ixzDRf1HC?si=5e279efcb8e54718&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8BR4TUAE-n4jYDgHqq4k-o5BEntPArEA3VT79kVHSUVzbQ0ZgZ_losBocT5waX5Q3tLP6KjVnrHAkI55tG-t7jdie3_Q&_hsmi=312000659&utm_content=312000659&utm_source=hs_email&nd=1&dlsi=a5b76988e55f40db
Boehringer takes the reins on inhaler costs while navigating a complex drug pricing environment
https://www.statnews.com/sponsor/2024/05/20/boehringer-takes-the-reins-on-inhaler-costs-while-navigating-a-complex-drug-pricing-environment/
The U.S. healthcare industry is ever evolving, and there is one thing everyone agrees on: it’s complex and often challenging for patients, especially those most vulnerable. One of the complexities that impacts the daily lives of many Americans is the high costs of necessary treatments.
Sun’s out, statistics out: The news you need for this week’s heat wave
https://www.wpc.ncep.noaa.gov/heatrisk/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--LIMX8eqMx5xJ7W3Ihp7XP7JNJCQ5vUuL3xUQndk10y8fP8iO0vybSAQPUbs7UsteAT6Yl5IzH6bLAAQIBUUsuYPdlfA&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
It’s going to be very, very hot this week in many parts of the country. If you need evidence to convince any stubborn family members that, no, they aren’t immune to extreme heat and, yes, we should put the AC in the window, then STAT has you covered.
https://www.statnews.com/2023/10/30/extreme-heat-cardiovascular-deaths/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--2oTpQ3xceXz8-bZwe5z6P2OpdMsIQKV2-Nr38UPImYdN-V9eV_iQ_uIEw9TvOCPWCLbtmPbZ3AZheVtt3f8_-crZRfw&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
What can the heat do to you? Last summer was the hottest in 2,000 years here in the northern hemisphere. Heat waves are associated with an increased risk of preterm birth; they can put your heart into ‘oxygen debt,’ in addition to triggering heart attacks and strokes.
https://www.statnews.com/2024/05/14/hottest-summer-2000-years-nature-study-climate-change-effects-health/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-89YU8WGe-8nYVlDBOMbiATXxwxH_bsM7cX6yJ01nFj7B55fd8qSIbAq_o3L1Cn0kQvBxhU_br6p_eGJIAgnZNQ1KOlNA&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Maybe someday we’ll get prescriptions for AC, but today is not that day. Not enough people currently have access to air conditioning, and this is just one of the factors experts are considering when looking toward a future of even more extreme heat. Another already-in-use option: rapid cooling body bags.
https://www.statnews.com/2023/10/31/extreme-heat-death-health-care-providers-doctors-resources-climate-change/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8qMx4P3j9UOgTxT6PG8nWHFKjPyUz2ZUXQv6A2powI5pv4yQtF46MhLgT1nQQIVNVC_TqFxaD1xL_7T7bxdbIPXecM1Q&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
https://www.statnews.com/2023/07/18/doctors-prepare-for-extreme-heat-climate-change/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-82TN_Uo1ODLw4OZB1GKnhsLv6Vrfir4ukniHNEw3_Tb8zv1R4N0OBm4TPqBiyZpndG2MbhUEHTnCKzlQdfztfAYnRFoQ&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Drug overdose deaths fell for first time in five years, though still exceeded 100,000 Lev Facher By Lev FacherMay 15, 2024
https://www.statnews.com/2024/05/15/opioid-overdose-deaths-2023-cdc/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8OXdgFN-_zSJ1jIoUI_85fcRfDjNWUqTiX6BncFxxl8JKAzJ2bjO9jRvptTJr8VS2RjAucUcj8KDO_yhqUj-W1N_QUvQ&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Not enough people are getting medicine after an overdose, study says
About 17% of people on Medicare who survived a drug overdose in 2020 experienced another one within a year, according to a new study in JAMA Internal Medicine. But a much smaller percentage — just 4% — received medication for opioid use disorder in the year after an overdose. These drugs, including methadone or buprenorphine, are effective, cheap, and easy-to-distribute treatments that can help people recover from addiction. Of the study’s 136,762 Medicare beneficiaries who survived an overdose, 1,323 died within a year.
Researchers from a collection of federal agencies including CDC, CMS, and NIH found that receiving addiction medication, filling a prescription for naloxone (an emergency medicine that can reverse overdose), and receiving a behavioral health assessment or crisis services all reduced a person’s odds of dying from an overdose in the year after surviving one. The results point to a continued need to improve access to these medications and services, the authors write. But you already know that if you read reporting from STAT’s Lev Facher on overdose deaths in the U.S., federal research on treatment, and how private equity got into the recovery business.
June 17, 2024
Overdose, Behavioral Health Services, and Medications for Opioid Use Disorder After a Nonfatal Overdose
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2820177?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_j5nN2-kCLBvOznZcbhwgakS5-jEqBQ2fpiYnAabyuJ4lHYo9Fjxv-tNSNrwxJhim8SOq-nLLRjCp-E8xVOUgiNjFkBw&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
How the U.S. is sabotaging its best tools to prevent deaths in the opioid epidemic
Lev Facher
By Lev Facher
https://www.statnews.com/2024/03/05/opioid-addiction-treatment-methadone-buprenorphine-restrictions/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--bvFHmnkwTfO7Ftac0vXI3T63fUICKpAEkvMb6AmSd0DtTY_uNSxNnFuwxM0MLgyQ5wXWqme_OrcCIS6Fx5xnkab13uQ&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
March 5, 2024
COERCIVE CARE For decades, physicians have steered sickle cell patients toward sterilization BY ERIC BOODMAN
https://www.statnews.com/coercive-care-sickle-cell-disease/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-86wKJCPVuxVWkOAyX_Ht06w4eR9VhXCVNmu-dqc0v1OBmXRoUn5cBgDR92Tiwv-5N_AkPzrQ1LS7Ff10LkHQihe7ddRA&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
Since the late 1970s, a federal rule has required any patient on Medicare or Medicaid to sign a consent form at least 30 days before a tubal ligation or vasectomy. The idea is to give people time to make a careful, fully-informed decision. It’s necessary protection — a previous investigation by STAT’s Eric Boodman found that, for decades, some women with sickle cell disease have felt pressured into getting sterilizations they didn’t want or didn’t fully understand.
But for some people, the waiting period can do more harm than good. For example: If you’re hoping for a tubal ligation during your C-section, but don’t know to ask for it far enough in advance, you might be out of luck. Or simply: A misplaced piece of paper could lead to, in the most extreme scenario, an unwanted pregnancy.
Now, 45 years after the rules came into effect, the federal government is quietly considering shortening the waiting period and clarifying the form. Read the latest story in Eric Boodman’s Coercive Care series, which asks the daunting ethical question of how to ensure true consent for a medical procedure as weighty as sterilization.
How doctors are pressuring sickle cell patients into unwanted sterilizations
Eric Boodman
By Eric Boodman
https://www.statnews.com/2024/05/21/sickle-cell-patients-steered-toward-sterilization-for-decades/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9ElKxDos1tG3FI41LfzWknsSpqxZ3uzjhcdtOG4vaJwu_pYR1ux5-G20ryYaorW3EVKYt1gj5ma1nPismlaQc0lbDKYw&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
This federal rule didn’t stop coercive sterilization — but it blocked contraceptive access. Can it be fixed?
Eric Boodman
By Eric Boodman
https://www.statnews.com/2024/06/18/sterilization-hhs-rule-did-not-stop-coercion-blocked-access/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_ofmSkZbXKPQJVtofJ-Hed3XdGkQyvOlYhjxS_99cXPPLYqHJtcueXqyV0dd7tzWgs24nMWcTpXzSVyFIsB-5OCUTRtw&_hsmi=312000659&utm_content=312000659&utm_source=hs_email
June 18, 2024
Medication Without Harm - How Digital Healthcare Tools Can Support Providers and Improve Patient Safety Event Date: July 24, 2024 | 2:30pm – 4:00pm ET
Medication Without Harm - How Digital Healthcare Tools Can Support Providers and Improve Patient Safety
Event Date: July 24, 2024 | 2:30pm – 4:00pm ET
https://digital.ahrq.gov/national-webinars/medication-without-harm-how-digital-healthcare-tools-can-support-providers-and
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling
Today, FDA announced a final rule that establishes certification regulations for certain medical gases and amends the requirements for current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling.
FDA has engaged with stakeholders and Congress for several years to gather input and evaluate the need for regulatory changes within the medical gas industry. This rule clarifies the regulatory obligations of entities that manufacture, process, pack, label, or distribute medical gases.
Key provisions established include:
Labeling requirements to clarify the statement of ingredients and quantity of contents, revise warning statements for certain designated medical gases, and establish more limited labeling requirements for bulk or transport containers.
CGMP requirements that recognize important differences in how medical gases are manufactured, labeled, and distributed, including the reuse of containers and labeling; mixing and commingling of gases; that gases are generally manufactured in a closed, pressurized system; and that many medical gases are generally not expected to expire or degrade.
Regulations to codify the certification process for designated medical gases, including provisions regarding supplemental applications, annual reporting, and withdrawal or revocation of approval of an application.
Safety reporting requirements that recognize certain events related to designated medical gases need not be reported to the agency.
FDA Published Report on Public Workshop to Enhance Clinical Study Diversity
https://www.fda.gov/media/179261/download?attachment=&utm_medium=email&utm_source=govdelivery
The U.S. Food and Drug Administration is announcing the publication of a report on topics discussed at the 2-day virtual public workshop titled “Public Workshop to Enhance Clinical Study Diversity,” held November 29 and 30, 2023.
FDA organized the workshop, in collaboration with the Clinical Trials Transformation Initiative, to discuss strategies to increase broader representation in clinical trials.
The report provides a summary of the workshop and does not provide guidance or reflect FDA’s current thinking on this subject. This report also satisfies a Food and Drug Omnibus Reform Act of 2022 mandate to publish a report on the workshop not later than 180 days after the close of the comment period.
https://ctti-clinicaltrials.org/virtual-public-workshop-to-enhance-clinical-study-diversity/?utm_medium=email&utm_source=govdelivery
OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers) By Kalie E. Richardson & John W.M. Claud —
https://mail.google.com/mail/u/0/#inbox/FMfcgzQVxHZZrLZRgzDNZmNTNtSfdPMT
FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. are safe, effective, and meet appropriate quality standards. While no office at FDA truly works in a vacuum, we can safely call OPQ the tip of FDA’s quality spear.
Facility Readiness: Goal Date Decisions Under GDUFA JUNE 2024
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/facility-readiness-goal-date-decisions-under-gdufa
This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter).
Introduction to FDA’s Office of Trade and Global Partnerships JULY 23, 2024
https://www.fda.gov/drugs/news-events-human-drugs/introduction-fdas-office-trade-and-global-partnerships-07232024
Date: July 23, 2024
Time: 1:00 PM - 2:00 PM ET
The goal of this webinar is to provide an introduction to FDA’s Office of Trade and Global Partnerships (OTGP). OTGP serves as the FDA lead for addressing issues related to international trade of regulated products, mutual recognition agreements, and entering into arrangements and sharing information with global counterparts. OTGP also serves as the FDA lead for addressing cross-cutting issues in multilateral organizations, such as the World Health Organization, and coordinates issues arising in multilateral forums within FDA.
Through the webinar, the audience will learn how OTGP’s work relates to pharmaceutical products and understand the different types of international agreements and arrangements used by FDA. The audience will also learn when and how to contact OTGP.
lunes, 17 de junio de 2024
New PBRN Learning Series: Registration Open for June 20 Webinar on Practice-Based Research Networks
New PBRN Learning Series: This page describes a new PBRN learning series of a June 20 webinar, Managing and Growing an Established PBRN, a July webinar, Highlighting and Promoting the Value of PBRNs, and an e-learning course, Building a Newer PBRN.
Register now for the first webinar in a new AHRQ Practice-Based Research Networks (PBRN) learning series to support and promote the work of PBRNs. The webinar, Managing and Growing an Established PBRN, is scheduled for June 20 from 4 to 5 p.m. ET. PBRNs engage practicing primary care clinicians in asking and answering clinical and organizational questions about primary healthcare. The webinar series will feature examples, information and advice from leaders actively working in PBRNs. It is sponsored by AHRQ’s National Center for Excellence in Primary Care Research and is open to anyone interested in working with PBRNs.
https://www.ahrq.gov/ncepcr/communities/pbrn/index.html
Antibiotics Not Associated with Shorter Duration or Reduced Severity of Acute Lower Respiratory Tract Infection
https://pubmed.ncbi.nlm.nih.gov/38619737/
Prescribed antibiotics did not reduce the duration and severity of coughing in patients with acute lower respiratory tract infections, a new AHRQ-funded study has found. The study, published in Journal of General Internal Medicine, analyzed data from more than 700 adult patients across primary and urgent care facilities in the United States. Researchers found that 29 percent of patients with cough and lower respiratory tract infection symptoms were prescribed antibiotics, but antibiotic provision did not affect cough duration or overall severity, regardless of viral, bacterial or mixed infections. Researchers concluded that patients had unrealistic expectations regarding the duration of lower respiratory tract infection and the effect of antibiotics, which should be the target of antibiotic stewardship efforts.
National Action Alliance for Patient and Workforce Safety
National Action Alliance for Patient and Workforce Safety
Register Now for June 18 Webinar on the National Action Alliance for Patient and Workforce Safety
Action Alliance
Registration is open for a webinar on June 18 from noon to 1 p.m. ET to highlight opportunities for elevating the patient voice when planning strategies for improving healthcare safety. The National Action Alliance for Patient and Workforce Safety, established by AHRQ on behalf of HHS, is a public-private collaboration that strives to improve safety across all healthcare settings. The webinar will feature presentations from experts at the Cincinnati College of Medicine who will discuss safety improvement efforts in pediatric care related to the following topics: listening to patient and family voices, strategies for meaningful engagement of patients and families, and the importance of workforce safety in driving patient safety. Access more information from previous National Action Alliance webinars and tools and resources to advance patient and workforce safety. Registration for future webinars is available on the National Action Alliance website.
https://www.ahrq.gov/action-alliance/webinars/index.html
AHRQ and Clinical Decision Support: Building the Bridge to Evidence-based Medicine
AHRQ and Clinical Decision Support: Building the Bridge to Evidence-based Medicine: Blog describes AHRQ's use of clinical decision support (CDS) and its use in AHRQ’s Digital Healthcare Research Program.
AHRQ Views: Advancing Evidence-Based Medicine With Clinical Decision Support
AHRQ’s ongoing research investments in clinical decision support (CDS) and its potential to help clinical teams recommend the latest evidence-based medicine to patients is the subject of a new AHRQ Views blog post. AHRQ’s Digital Healthcare Research Program has supported CDS research, implementation and demonstration projects throughout its 20-year history. Among other initiatives, AHRQ’s CDS Connect provides a web-based platform for authoring, sharing and reusing CDS so healthcare systems and developers can build upon what has already been developed. A recent Notice of Intent signaled AHRQ’s intent to fund new research on patient-centered CDS to explore how to involve patients, families and caregivers in CDS development. Access the blog post.
https://digital.ahrq.gov/
https://cds.ahrq.gov/cdsconnect
AHRQ’s Healthcare Extension Service—State-Based Solutions to Health Care Improvement
https://jamanetwork.com/journals/jama/article-abstract/2819779
AHRQ Announces Plans for National Healthcare Extension Service To Disseminate Evidence
A Notice of Information issued by AHRQ signals the agency’s intent to publish a Notice of Funding Opportunity to create state-based healthcare extension cooperatives to increase the use of patient-centered outcomes research evidence in clinical practice. Cooperatives will work with Medicaid agencies, managed care organizations, community groups, policy and payment experts and others to improve care delivery. AHRQ will also issue funding opportunities for two related projects: a national coordinating center and a national evaluation center. Working together, these projects will be designed to accelerate the dissemination and implementation of patient-centered outcomes research evidence through improvements in healthcare policy, payment and practice, and to reduce healthcare disparities, especially among people who receive Medicaid, are uninsured or are otherwise medically underserved. Access more information about the initiative, plus a recent JAMA Network viewpoint article by AHRQ experts.
https://grants.nih.gov/grants/guide/notice-files/NOT-HS-24-016.html
Global health leader critiques ‘ineptitude’ of U.S. response to bird flu outbreak among cows Andrew Joseph By Andrew Joseph June 13, 2024
https://www.statnews.com/2024/06/13/global-health-leader-critiques-ineptitude-of-u-s-response-to-bird-flu-outbreak-among-cows/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8zUxaihUr_cufBneEN29rPfkaTuL-txUPRbiYyGo3-XFo2R55QYXZNUWDgugjkNxHcek7vynArb35Q44KrE7pFP0QPTw&_hsmi=311840667&utm_content=311840667&utm_source=hs_email
Seth Berkley, the former head of Gavi, the Vaccine Alliance, gave voice last week to a point of view STAT has been hearing for a while about the U.S. response to the H5N1 bird flu outbreak in dairy cows. “It’s been shocking to watch the ineptitude,” Berkley, an American currently living in Switzerland, said at an event on the future of vaccines held in London.
Tracking bird flu virus changes in cows is stymied by missing data, scientists say
Helen Branswell
By Helen Branswell May 2, 2024
https://www.statnews.com/2024/05/02/bird-flu-in-cows-h5n1-virus-changes-missing-data/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8sEXGXz0MR-wuLj8gGi4WLs4-h-u4BPve6QHCjLaZz-GkoXZPP-sc7vBRDeVPHtED9G4gR9M3HxSUb1SHcqfnN-LwN4Q&_hsmi=311840667&utm_content=311840667&utm_source=hs_email
Berkley was talking, among other things, about the surveillance being done to try to get a handle on how widespread the outbreak has actually become. It has been nearly three months since the virus was first identified in cattle, and the country is no closer to an answer to that question. As of Friday, the U.S. Department of Agriculture had confirmed infections in 102 herds in 12 states; Iowa, one of the latest states to report infected herds, announced it had found two more that haven’t yet made it to the USDA list. To date three people — all farmworkers — have contracted the virus from cows.
Highly Pathogenic Avian Influenza Cases Detected in Two Northwest Iowa Dairies
https://iowaagriculture.gov/news/HPAI-detected-2-NW-iowa-dairies?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--kS8wzKMrHoHR3ESlf5038GzWo6ssQseoBDUNJCqAZfwNsdVSBYfJ1eeXY-w44Q3aP3KXY3_bwHmIG5LZQRGRadITSng&_hsmi=311840667&utm_content=311840667&utm_source=hs_email
Have any of the affected herds cleared their infections? If so, how many? The USDA couldn’t answer those questions on Thursday. And yet Agriculture Secretary Tom Vilsack confidently declared at a press conference earlier this month that his department feels it knows how the virus is moving between herds and how to stop it. “We are trying to essentially corner the virus,” Vilsack said, despite the fact that operators of only 11 of the affected herds have applied for USDA help to improve biosecurity on their farms and defray testing costs.
In dribs and drabs, USDA reports suggest containing bird flu outbreak in dairy cows will be challenging
Helen Branswell
By Helen Branswell June 13, 2024
https://www.statnews.com/2024/06/13/h5n1-bird-flu-usda-reports/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_oTipTi4kxPPX9uelB1kHqQM1yXcGMpySHjhN4vhUBBxardoo9yOJDxk2wpQQiK5w1xMfWYaDN2UjoRQMhFt4r6RM-Uw&_hsmi=311840667&utm_content=311840667&utm_source=hs_email
USDA aims to isolate, exhaust H5N1 virus in dairy herds
The government has faced repeated questions about whether it knows for certain how widespread bird flu in cattle is. To date, H5N1 has been confirmed in 80 herds in nine states.
https://www.agriculture.com/usda-aims-to-isolate-exhaust-h5n1-virus-in-dairy-herds-8657880?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8hjSbfqQ57uhTuyc2e4cqgbLyCmMWzIS4AteRH-wURVUz3LQ0x-YTmG9PEyBsB_UutVvYoR3I9KQNFKbiv2P6HulfJZg&_hsmi=311840667&utm_content=311840667&utm_source=hs_email
The government’s seeming inability to get farmers to disclose that they have infected animals has many worried observers wishing more states were doing what Michigan’s doing. True, it has more declared herds than any other state. But that’s because its response is more robust, fans of the state’s approach say. “One of our mantras is if you don’t test for it you don’t find it,” the state’s chief medical executive, Natasha Bagdasarian, told STAT in an interview.
- Helen Branswell
Michigan stands out for its aggressive bird flu response. Will other states follow its lead?
Megan Molteni
By Megan Molteni June 12, 2024
https://www.statnews.com/2024/06/12/h5n1-bird-flu-michigan-testing-more-animals-humans-than-other-states/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--XtwuL8mGI_bjm8eww7fYDwrG7TBNmcgr7ZTYsWmKN-k0T-l1wJGAyZXDmRZwMeC9AdIQMxp7BNFl4U8NzhP5ObtmYyw&_hsmi=311840667&utm_content=311840667&utm_source=hs_email
By Chuck Abbott Published on June 4, 2024
Community-centred strategies in public health surveillance Spencer G Lawson,Evan M Lowder The Lancet Public Health
Community-centred strategies in public health surveillance
Spencer G Lawson,Evan M Lowder
The Lancet Public Health
https://www.thelancet.com/journals/lanpub/issue/vol9no6/PIIS2468-2667(24)X0006-7
Sexual violence in the workplace and associated health outcomes: a nationwide, cross-sectional analysis of women in Iceland
https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(24)00075-6/fulltext?dgcid=hubspot_update_feature_updatealerts_lanpub&utm_campaign=update-lanpub&utm_medium=email&_hsenc=p2ANqtz--tQXJK9jXwBbPyNraeLOcNn2Y7OsaGyLSfgLH74enE9fGLgTVh2Wc4fb2jMQxzk3rwzqkQCjcI-vTfwtA6GFyYUXu5Fw&_hsmi=311104762&utm_content=311059151&utm_source=hs_email
Rethinking information ecosystems and infodemics
The Lancet Public Health
https://www.thelancet.com/journals/lanpub/issue/vol9no6/PIIS2468-2667(24)X0006-7
Insurer strategies to control costs associated with weight loss drugs By Justin Lo and Cynthia Cox Twitter KFF June 12, 2024
https://www.healthsystemtracker.org/brief/insurer-strategies-to-control-costs-associated-with-weight-loss-drugs/?_hsenc=p2ANqtz--yJM-KjV1Protr6BHjvQUUT7lzO_2gglr4qWV68MokusW836uhMfdqnayWVxFDOiJK9L8PTs75NqrBpMATY-Jd13FMKg&_hsmi=311243360&utm_campaign=KFF-Peterson&utm_medium=email&utm_content=311243360&utm_source=hs_email
Costly GLP-1 Drugs are Rarely Covered for Weight Loss by Marketplace Plans
For Drugs Used to Treat Diabetes, Plans Almost Always Require Prior Authorization or Other Utilization Management
Affordable Care Act (ACA) Marketplace plans rarely cover GLP-1 drugs approved solely for obesity treatment, according to a new KFF analysis of 2024 federal plan data. Wegovy, a drug that is approved for weight loss, is covered by just 1% of Marketplace prescription drug plans, compared to 82% of Marketplace prescription drug plans for Ozempic, which contains the same active ingredient as Wegovy (semaglutide) but is approved only for diabetes.
When GLP-1 drugs are covered for diabetes treatment, almost all plans use at least one utilization management strategy to control costs, such as prior authorization or quantity limits. Of the few Marketplace plans that cover GLP-1 drugs approved for obesity, all require prior authorization.
Utilization management tools are intended to balance cost control and access but may still pose barriers for people with a medical necessity to take these drugs. While insurers receive rebates to offset some of their costs, the list prices of GLP-1 drugs are about $1,000 per month, and growing demand for these medications could put upward pressure on premiums.
This analysis examines publicly available formularies of plans available on the federally facilitated ACA Marketplaces in 2024 and does not include states that run their own Marketplaces, where coverage patterns may differ. The ACA Marketplaces represent a small share of people with private health insurance, as most people with private coverage have plans sponsored by their employers. While information on employer plan formularies is not publicly available, these plans may be more likely to cover drugs for weight loss than ACA Marketplace plans given the desire to attract workers, though they may employ similar utilization management strategies.
MEDIA CONTACT:
Tammie Smith | 202.654.1410 | TammieS@kff.org
domingo, 16 de junio de 2024
Research biobank participants attitudes towards genetic exceptionalism and health record confidentiality. Victoria Dortenzio et al. J Community Genet 2024 3 (Posted Apr 08, 2024 9AM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=fhh&query=home
From the abstract: "The goals of this study were to determine biobank participants’ attitudes towards genetic exceptionalism and confidentiality and whether those attitudes are related to their preference for return of genetic results. An online questionnaire was distributed to patients with an EHR and email address who had previously enrolled in the BioMe Biobank program. Most participants responded with similar levels of concern in scenarios involving the use of genetic information and other types of health information, suggesting that participants want similar protections for genetic data as other types of sensitive health information, particularly mental health and family history records. "
An approach to identify gene-environment interactions and reveal new biological insight in complex traits (Posted Apr 25, 2024 9AM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=environmental&query=home
From the abstract: " Here, we present a powerful new approach to screen for interactions across the genome, an approach that shares substantial similarity to the Mendelian randomization framework. We identify and confirm 5 loci (6 independent signals) interacted with either cigarette smoking or alcohol consumption for serum lipids, and empirically demonstrate that interaction and mediation are the major contributors to genetic effect size heterogeneity across populations. "
Systematic reanalysis of genomic data by diagnostic laboratories: a scoping review of ethical, economic, legal and (psycho)social implications. Marije A van der Geest et al. Eur J Hum Genet 2024 3 (Posted Mar 18, 2024 9AM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=economic&query=home
From the abstract: "In total, we identified nine ELSI aspects, such as (perceived) professional responsibilities, implications for consent and cost-effectiveness. The identified ELSI aspects brought forward necessary trade-offs for GHPs to consciously take into account when considering responsible implementation of systematic reanalysis of NGS data in routine diagnostics, balancing the various strains on their laboratories and personnel while creating optimal results for new and former patients. "
Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes (Posted May 03, 2024 5PM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=diabetes&query=home
From the abstract: " Few young people with type 1 diabetes (T1D) meet glucose targets. Continuous glucose monitoring improves glycemia, but access is not equitable. We prospectively assessed the impact of a systematic and equitable digital-health-team-based care program implementing tighter glucose targets (HbA1c?
Harnessing population-wide health data to predict cancer risk (Posted May 26, 2024 11AM)
https://phgkb.cdc.gov/PHGKB/specificPHGKB.action?topic=cancer&query=home
From the article: "In an era of big data and efficient computing, the development of complex risk models has become substantially easier than assessing whether, how, and in what context they are useful. The 1976 observation by George E P Box that “All models are wrong but some are useful remains equally true nearly 50 years later. Only time will tell whether the impressive advances since Box's observation in our ability to build risk models will ultimately prove useful for cancer prevention. "
sábado, 15 de junio de 2024
Listen to the Latest ‘KFF Health News Minute’ JUNE 11, 2024
https://kffhealthnews.org/news/article/listen-to-the-latest-kff-health-news-minute-2024/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8oTIwNmqohGUJ2UlUF57PKbX398eStzNy3oUj5bNoEINtB5g5uUirZh_Q5KDzFN3i4o7zCYwnCLsCD2fOoA6kpWEnn6w&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Listen to the Latest ‘KFF Health News Minute’
“Health Minute” brings original health care and health policy reporting from the KFF Health News newsroom to the airwaves each week.
Journalists Discuss Abortion Laws, Pollution, and Potential Changes to Obamacare Subsidies JUNE 8, 2024
https://kffhealthnews.org/news/article/on-air-june-8-2024-abortion-laws-pollution-aca-subsidies/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--gU6u8806N7AjuaG2LpVFQroW_74Dho0i5nrwk0ELiZ9JTXOU_XkNIW7DvHJxIVTs1PoORrrHXAehJixsQATehJQt_Ww&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Journalists Discuss Abortion Laws, Pollution, and Potential Changes to Obamacare Subsidies
KFF Health News and California Healthline staff made the rounds on national and local media in the last two weeks to discuss topical stories. Here’s a collection of their appearances.
Watch: California Pays Drug Users To Stay Clean JUNE 13, 2024
https://kffhealthnews.org/news/article/california-pays-drug-users-to-stay-clean-broadcast-appearance/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--bwGdW85aUkHp34FUvFxle7M9tglX2ZSzthjr1CS7UQ6AXQSXMDZrYTpM7M-TF05YP1__6rzj70xSIZVWkPBsDC8N6Pw&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Watch: California Pays Drug Users To Stay Clean
KFF Health News senior correspondent Angela Hart discusses a state Medicaid experiment for people addicted to methamphetamine, cocaine, and other stimulants. For every clean urine test, they can earn money — up to $599 a year.
SCOTUS Rejects Abortion Pill Challenge — For Now EPISODE 351 JUNE 13, 2024
https://kffhealthnews.org/news/podcast/what-the-health-351-supreme-court-abortion-pill-mifepristone-june-13-2024/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8_AW-xE3Qd8ZOKG5e3gAVlctrseNGpt7g7j0-4AgabW_JezYN2q6I8ryZeyxg42ys1182tM0iKn3avglzpLEbx65TvVw&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
KFF Health News' 'What the Health?': SCOTUS Rejects Abortion Pill Challenge — For Now
The Supreme Court has dismissed a challenge to the FDA’s approval of the abortion pill mifepristone, ruling unanimously that the anti-abortion doctor group that filed the suit lacked standing. But abortion opponents are expected to pursue other strategies to ban or restrict the medication. Meanwhile, the Biden administration moves to stop the inclusion of medical debt on individual credit reports, and former President Donald Trump tries to claim credit for $35 insulin. Anna Edney of Bloomberg News, Rachana Pradhan of KFF Health News, and Emmarie Huetteman of KFF Health News join KFF Health News chief Washington correspondent Julie Rovner to discuss these stories and more. Also this week, Rovner interviews KFF president and CEO Drew Altman about KFF’s new “Health Policy 101” primer.
Heat Rules for California Workers Would Also Help Keep Schoolchildren Cool By Samantha Young JUNE 10, 2024
https://kffhealthnews.org/news/article/california-indoor-heat-rules-schools-children-cooling/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--bU-zFWnNOotIRMx0KxA2XSjizS3zYlV0owLovA9Y1PE9BlG9osM-gQatxRwcwL_GFJ-yyDoFmHZwGafkSG7uzAD9KXg&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Heat Rules for California Workers Would Also Help Keep Schoolchildren Cool
By Samantha Young
Proposed state standards to protect indoor workers from extreme heat would extend to schools. The rules come as climate change is bringing more frequent and intense heat waves, causing schools nationwide to cancel instruction.
Many Young Adults Who Began Vaping as Teens Can’t Shake the Habit By John Daley, Colorado Public Radio JUNE 12, 2024
https://kffhealthnews.org/news/article/generation-vape-teen-habit-young-adult-addiction/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_6dlolOwOV2o5aOrJqmjHacrYAuEDQTsKnZdyq1yTu26lIZflxvNVpHKIv2miVxqwGXY23FzmkAY-UQFJwmGP5p1G3ng&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Many Young Adults Who Began Vaping as Teens Can’t Shake the Habit
By John Daley, Colorado Public Radio
New data on substance use among young adults suggests that many former teen e-cigarette users are continuing the habit.
Bird Flu Tests Are Hard To Get. So How Will We Know When To Sound the Pandemic Alarm? By Amy Maxmen and Arthur Allen JUNE 11, 2024
https://kffhealthnews.org/news/article/bird-flu-tests-pandemic-possibility-preparedness/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_S02eqqG3npvbp-tCTWIQX0isU1WBAJY0le4cvTKcSZrjU_LXEPzQTYpaA3LEXVT2FWpyzXLR5hTtIDVe6ky9YRxELkw&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Bird Flu Tests Are Hard To Get. So How Will We Know When To Sound the Pandemic Alarm?
By Amy Maxmen and Arthur Allen
If widely used, flu tests could be helpful now. In the meantime, the government needs to clear a path for H5N1 tests, researchers warn, to avoid the early missteps of the covid pandemic.
‘I Try To Stay Strong’: Mom Struggles To Get Diagnosis for Son’s Developmental Problems By Sejal Parekh JUNE 12, 2024
https://kffhealthnews.org/news/article/alameda-county-california-mom-diagnosis-child-behavioral-issues/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9QoxcjeD17eRHbbYapPzKD1iwKeJG36EAX7nmVuJyd6FZ5YjuDz4xvBpAZV8xLAKiDHDZ9R0ezkKgU7THyjBJGZcF-kQ&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
‘I Try To Stay Strong’: Mom Struggles To Get Diagnosis for Son’s Developmental Problems
By Sejal Parekh
An Alameda County mother has spent 10 months seeking help for her 4-year-old son’s speech and behavior issues from his school district and her Medicaid health insurer. She still doesn’t have an answer.
California Lawmakers Preserve Aid to Older, Disabled Immigrants By Vanessa G. Sánchez JUNE 14, 2024
https://kffhealthnews.org/news/article/california-lawmakers-aid-immigrants-in-home-services-budget-newsom/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--5YAc1aJspXSb0Fw3d73uCBMS6UJqStYWKQKjcLV-WGBBoY4S9roLiOH49n-K-wZebfPjVgSlPvJuqk1IEUudoQwV-ww&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
California Lawmakers Preserve Aid to Older, Disabled Immigrants
By Vanessa G. Sánchez
Lawmakers passed a budget that rejected Gov. Gavin Newsom’s proposal to save nearly $95 million by eliminating in-home support services for qualifying older, blind, and disabled immigrants lacking legal residency. Advocates say Newsom’s plan would have cost more in the long run. Newsom has not indicated whether he’ll veto.
Nursing Homes Are Left in the Dark as More Utilities Cut Power To Prevent Wildfires By Kate Ruder JUNE 10, 2024
https://kffhealthnews.org/news/article/nursing-homes-power-shut-offs-outages-wildfires-preparedness/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8adq85MhuXp-FjiplC4gZcx9wd1Szg6fL9YlwGXd79zmscK96QhmQjCwwUvd3rVOV_5tByeylUeT6mJGNogjTopZDO6Q&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Nursing Homes Are Left in the Dark as More Utilities Cut Power To Prevent Wildfires
By Kate Ruder
A nursing home in Colorado had 75 minutes to prepare for a power outage that lasted 28 hours. Such public safety power shut-offs are being used more often as a fire prevention tool, but not all health facilities are prepared.
Funding Instability Plagues Program That Brings Docs to Underserved Areas By Michelle Andrews JUNE 13, 2024
https://kffhealthnews.org/news/article/physician-teaching-health-centers-funding-instability-underserved-areas/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_7IztIHO2ufu4ByP6ul854O4e21iNKSYVANie8DDJCPTM3TRPDBU53deUafELdldxbI_mTglNMNhZfUULhn6PN9QCS1w&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Funding Instability Plagues Program That Brings Docs to Underserved Areas
By Michelle Andrews
A medical residency program designed to train future primary care physicians in outpatient rather than hospital settings has proved an effective means to bring doctors to rural and underserved areas. But it hinges on unpredictable congressional funding.
Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals By Samantha Liss JUNE 14, 2024
https://kffhealthnews.org/news/article/indiana-copa-hospital-monopoly-scrutiny/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8z8EE64rVcj8Z0mVsCYcVCZFrYqyO5QCPZVHrGpJtEapTKa4YXrL_XfPPfQ1hx0YcQJIp0mOkyqhT05wQqtfVe-f2Knw&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals
By Samantha Liss
If Indiana officials approve a proposed hospital merger in western Indiana in the coming months, the state will have its first hospital monopoly created by a “Certificate of Public Advantage.” Other such deals have resulted in government reports documenting diminished care in Tennessee and North Carolina.
Biden’s on Target About What Repealing ACA Would Mean for Preexisting Condition Protections By Jacob Gardenswartz JUNE 13, 2024
https://kffhealthnews.org/news/article/fact-check-biden-campaign-ad-repealing-obamacare-preexisting-conditions/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9Jb8F6By49BdhtDaMdfNPD2U6Mi2Yut9c-f7ZVO7Rhl2ykpG8uIaL6L78e5UJr4YeM37LJK68_923-i5X9NiWUPyEZ1A&_hsmi=311632835&utm_content=311632835&utm_source=hs_email
KFF HEALTH NEWS & POLITIFACT HEALTHCHECK
Biden’s on Target About What Repealing ACA Would Mean for Preexisting Condition Protections
By Jacob Gardenswartz
A Biden campaign ad highlighting how an Obamacare repeal would affect people with preexisting conditions is mostly true.
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