Journal of Inflammation
Hace 22 horas
lunes, 25 de septiembre de 2023
What ever happened to biotech’s big comeback? Allison DeAngelis Damian Garde By Allison DeAngelis and Damian Garde Sept. 25, 2023
https://www.statnews.com/2023/09/25/biotech-stock-comeback/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275436977&_hsenc=p2ANqtz-_UdRg6s0_hm08dHcn63_pQEya6yfUTbNsBFFwYTh6yFkYLNE0edsDZ5iHPDL2N8nJRuOMR7G9xEb7_EbRyR5jE9OcySA&utm_content=275436977&utm_source=hs_email
After a couple bruising years on Wall Street, 2023 was supposed to bring about a recovery for the biotech industry. Instead, a closely watched biotech stock index has fallen about 10% for the year, dramatically underperforming the broader market and making it that much more difficult for cash-strapped companies to finance their science.
But there’s reason to believe the worst is over, STAT’s Allison DeAngelis and Damian Garde report. In just the last two weeks, two biotech companies successfully went public, and on Wednesday, the Federal Reserve projected that interest rates will drop next year, welcome news for a sector that had fallen out of favor with risk-averse investors. Venture capitalists are increasingly confident the market will support initial public offerings for biotech companies, and executives are dusting off their long-shelved IPO paperwork. Read more.
Pfizer RSV vaccine wins CDC recommendation for seasonal use only Helen Branswell By Helen Branswell Sept. 22, 2023
https://www.statnews.com/2023/09/22/pfizer-rsv-vaccine-cdc-seasonal-recommendation/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275436977&_hsenc=p2ANqtz-9mYIMtnydWyBvKQTvyXulE_LExU8sDYh9WkGpKiEJWlGZ8XdNmiHU6fV-5xfRYZdCmJZ8ZNHqlA_g8zgcSdS_CeSxrzg&utm_content=275436977&utm_source=hs_email
CDC backs maternal RSV vaccine for seasonal use
Pfizer’s new shot to protect infants against RSV by vaccinating their mothers late in pregnancy won a limited recommendation Friday from an expert panel that advises the Centers for Disease Control and Prevention, STAT's Helen Branswell reports. The panel said the vaccine should be given to pregnant women between September and January in order to protect babies born between October and March, when RSV traditionally peaks.
“This is another new tool we can use this fall and winter to help protect lives,” CDC Director Mandy Cohen said in a statement.
A monoclonal antibody to protect newborns from RSV was also recently approved — but experts told Branswell earlier this year they were worried the U.S. may not put this new arsenal of tools to good use. Read more about Pfizer's new vaccine.
COLOR CODE
STAT’s bi-weekly podcast, hosted by award-winning journalist and host Nicholas St. Fleur, weaves together stories and experiences of physicians, patients, historians, and other experts to illuminate the history of racism in the health care system and how it has — and continues — to impact people of color and underserved communities. Sign up to get notified each time a new episode drops, and subscribe today on Apple, Spotify, Pocket, Overcast, Soundcloud, Google, and Podcast Addict. This podcast was made possible with support from the Commonwealth Fund
https://www.statnews.com/category/color-code/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275436977&_hsenc=p2ANqtz-9JZMFNZ99yQFDxSBrn9zoHLXk1s6dtXXtp4fsgKTkAOoiFUpGQEQ3LXLPukle6HGVGv7oWfCJLULNwc-GF714KC-8mpA&utm_content=275436977&utm_source=hs_email
Physician Jennifer McKenney never knows what she might see in her rural emergency room in Fredonia, Kansas, where she is 80 miles from the nearest city. Rattlesnake bites, car accidents, toothaches — anything is possible, and sometimes she’s the only one there to deal with it.
For decades, rural areas like Fredonia have been facing a physician shortage. More than 46 million Americans, or 15% of the U.S. population, live in rural areas, but only 10% of doctors serve in these communities. In the first video of a special series focused on rural health, special projects editor Hyacinth Empinado explores how we got here — hint: it might have something to do with the Flexner Report, which Hyacinth and I first learned about while working on Color Code — and how the deficit might be addressed. Watch the video.
PEPFAR, one of the greatest public health inventions of our time, is at risk By Arjun Sharma
https://www.statnews.com/2023/09/13/pepfar-hiv-aids-womens-health-africa/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275436977&_hsenc=p2ANqtz--iJxzegn9lh9K0zpFe8-34Q-ZwE7-Yks-cx_oMwEQpPh-FQFRbWiMSyjlYvBWtntXnO1694dygwHnOgbd2EWSj1wzVPw&utm_content=275436977&utm_source=hs_email
The federal government runs out of money Oct. 1, and Congress still hasn’t clinched a deal — which means Washington is on shutdown watch this week. That’s bad news for staff at the various health care agencies, who might have to stop working temporarily or work without pay.
There are also questions about whether Congress will use the government funding moment to extend crucial federal money for community health centers and other health programs. Programs to fight AIDS globally and prepare for pandemics are set to expire at the end of the month.
However, my colleague John Wilkerson reports that HHS will continue providing many critical services. Nearly 60% of HHS workers would work through a shutdown, either because they’re deemed essential or because their operating divisions are already funded. For example, 81% of FDA staff would stay on, due in large part to user fees that companies pay for medical product reviews.
Cancer drug shortages widen disparities between big systems and small Angus Chen By Angus Chen
https://www.statnews.com/2023/09/25/cancer-drug-shortages-cisplatin-disparities/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275436977&_hsenc=p2ANqtz-8mqzzDMs7R63MhqwN3DohPVHO-sQzi1dEd7q0gcyV5tJZkB3ApNoXSV-M-DLhLSht2T20IqRCY7yyBLNHLlhEN_f0gXg&utm_content=275436977&utm_source=hs_email
While a months-long shortage of key chemotherapies has been a strain on practically all oncology practices, some clinics were able to secure supplies for their patients — while others struggled more. The difference was often in the size of the clinic, STAT’s Angus Chen reports, as larger clinics have key advantages — chief among them pharmacy teams that dedicated time to managing shortages and had access to more distributors.
In some cases, smaller community practices that struggled to maintain a chemotherapy supply during the shortage have had to send patients to larger systems for infusions. That translates to lost income for these practices, a problem some oncologists could become more common as drug shortages persist.
“Small practices are already struggling. In rural areas where access is a huge problem, the closest center may be hundreds of miles away,” said Kristin Rice, an oncologist at Medical Oncology Associates of San Diego. “We cannot afford to lose those small practices.” Read more.
domingo, 24 de septiembre de 2023
Neighborhood Disadvantage, African Genetic Ancestry, Cancer Subtype, and Mortality Among Breast Cancer Survivors HS Iyer et al, JAMA Network Open, August 30, 2023Neighborhood Disadvantage, African Genetic Ancestry, Cancer Subtype, and Mortality Among Breast Cancer Survivors HS Iyer et al, JAMA Network Open, August 30, 2023
Understanding the divergent evolution andepidemiology of H3N8 influenza viruses indogs andhorses Wasik BR , Rothschild E , Voorhees IEH , Reedy SE , Murcia PR , Pusterla N , Chambers TM , Goodman LB , Holmes EC , Kile JC , Parrish CR . Virus Evol 2023 9 (2) vead052 Understanding the divergent evolution andepidemiology of H3N8 influenza viruses indogs andhorses Wasik BR , Rothschild E , Voorhees IEH , Reedy SE , Murcia PR , Pusterla N , Chambers TM , Goodman LB , Holmes EC , Kile JC , Parrish CR . Virus Evol 2023 9 (2) vead052
Cost-Effectiveness Analysis in Public Health Genomics and Precision Health: Recent Findings, Methodologic Issues, and the Path Forward
https://www.cdc.gov/genomics/events/cost_effectiveness_2023.htm
Cost-Effectiveness Analysis in Public Health Genomics and Precision Health: Recent Findings, Methodologic Issues, and the Path Forward
October 26, 2023, 11:00 am – 12:00 pm ET
sábado, 23 de septiembre de 2023
Uncovering the shocking dangers of misdiagnosis.
https://psnet.ahrq.gov/issue/uncovering-shocking-dangers-misdiagnosis
Misdiagnosis continues to impact the safety of health care. This podcast with David Newman-Toker discusses foundational issues that detract from diagnostic safety and examines how teamwork, training, technology, tuning can make the process more reliable. Strategies for patients to play a role in their diagnostic process are also discussed.
Global Knowledge Sharing Platform for Patient Safety.
https://psnet.ahrq.gov/issue/global-knowledge-sharing-platform-patient-safety
The sharing of best practices is a key component of enabling successful strategy implementation in support of patient safety plans and goals. This website will capture, organize, and share experiences worldwide to support knowledge sharing and community building to reduce World Patient Safety Day targeted challenges.
‘Dr. Google’ meets its match: Dr. ChatGPT.
The use of artificial intelligence (AI) holds potential for health care improvement that is beginning to be documented. This article discusses ChatGPT in the context of wide availability of internet search tools as a mechanism for patients to find answers to clinical questions. It summarizes clinicians’ concerns about the tools and strategies to being used to ensure the accuracy and safety of these searches.
https://psnet.ahrq.gov/issue/dr-google-meets-its-match-dr-chatgpt
Understanding And Addressing Pre-Hospital Diagnostic Delays.
https://psnet.ahrq.gov/issue/understanding-and-addressing-pre-hospital-diagnostic-delays
Diagnostic delays stem from both human and process failures. This series of articles examines how strategies such as behavioral design, internet use, and prehospital practice play a role in the timing of diagnosis.
How Columbia ignored women, undermined prosecutors and protected a predator for more than 20 years.
https://psnet.ahrq.gov/issue/how-columbia-ignored-women-undermined-prosecutors-and-protected-predator-more-20-years
Sexual abuse of a patient is a never event. This article discusses how criminal behavior remained latent at a large health system due to persistent disregard of patient concerns, which enabled a serial sexual abuser to continue to practice medicine. The harm to the victims and fear of the peers who knew of the situation and were not psychologically safe enough to report it, are discussed.
California pharmacies are making millions of mistakes. They’re fighting to keep that secret.
https://psnet.ahrq.gov/issue/california-pharmacies-are-making-millions-mistakes-theyre-fighting-keep-secret
Safe practice in community pharmacy is challenged by production pressure, workforce shortages, and multitasking. This story examined the mistakes made at major retail pharmacy chains in California. It provides examples perpetrated across the industry to target universal areas of needed improvement and potential strategies to address them.
Wake-up call: night shifts adversely affect nurse health and retention, patient and public safety, and costs.
https://psnet.ahrq.gov/issue/wake-call-night-shifts-adversely-affect-nurse-health-and-retention-patient-and-public-safety
Extended and overnight shifts are associated with higher adverse event rates and burnout. This mini review summarizes the impact of overnight shifts on nurses' health, patient and public safety, and organizational costs (e.g., those related to nurse turnover). Organizational strategies to promote nurses' health and reduce errors are also summarized, ranging from low-cost measures such as breaks for physical activity during the shift to high-cost measures such as referral to sleep specialists or paid transportation home.
Defining speaking up in the healthcare system: a systematic review.
https://psnet.ahrq.gov/issue/defining-speaking-healthcare-system-systematic-review
Clinicians and staff are encouraged to speak up about safety concerns as a part of patient safety culture. This review had two aims: to review the literature on speaking up for patient safety, and to develop a single definition of "speaking up" in healthcare. 294 articles were identified with 51 directly focused on speaking up and the remaining on other aspects such as communication. 11 distinct definitions were identified from which the authors developed a single definition: a healthcare professional identifying a concern that might impact patient safety and using his or her voice to raise the concern to someone with the power to address it.
Problems and paradoxes of reliability and resilience in organizational networks.
https://psnet.ahrq.gov/issue/problems-and-paradoxes-reliability-and-resilience-organizational-networks
Organizational resilience and high reliability principles take a proactive approach to ensuring patient safety. Using a safety science perspective, this article highlights key features of organizational and network reliability and resilience and the challenges in applying these features to complex systems.
Enhancing patient safety: a national standard for cyber resiliency in healthcare.
https://psnet.ahrq.gov/issue/enhancing-patient-safety-national-standard-cyber-resiliency-healthcare
The threat of cybersecurity risks to patient safety is receiving increasing attention. This article describes the development of a new standard to support cyber resiliency in Canada’s healthcare system. The guidance addresses key areas of concern (e.g., organizational risk management, technology considerations, contingency planning), provides suggested roles and responsibilities for an organizational cybersecurity team, and emphasizes the importance of cyber incident response planning.
Factors associated with neuroradiologic diagnostic errors at a large tertiary-care academic medical center: a case-control study.
https://psnet.ahrq.gov/issue/factors-associated-neuroradiologic-diagnostic-errors-large-tertiary-care-academic-medical
Like many clinical areas, a variety of system factors can influence diagnostic error rates in neuroradiology. This study included 564 neuroradiologic examinations with diagnostic error and 1,019 without error. Diagnostic errors were associated with longer interpretation times, higher shift volume, and weekend interpretation.
From battles to burnout: investigating the role of interphysician conflict in physician burnout.
https://psnet.ahrq.gov/issue/battles-burnout-investigating-role-interphysician-conflict-physician-burnout
Disruptive behaviors, including experiencing or witnessing coworker conflict, can lead to staff burnout and adverse events. In this study, emergency medicine and internal medicine physicians reported on conflicts with other physicians they'd experienced in the workplace. Participants reported feeling demoralized and burnt out after a conflict and brought those feelings to future interactions, priming the situation for additional conflict.
Impact of pharmacist-led admission medication reconciliation on patient outcomes in a large health system.
https://psnet.ahrq.gov/issue/impact-pharmacist-led-admission-medication-reconciliation-patient-outcomes-large-health
Obtaining a best possible medication history (BPM) is an important component of successful medication reconciliation programs. This study compared the impact of a pharmacy-led medication reconciliation program including BPMH on adverse drug events (ADEs) and complications among high-risk, complex patients across 16 hospitals. In the six months following implementation, 80,000 reconciliations were completed and nearly 40% required additional medication follow-up and/or clarification. Researchers identified a statistically significant decrease in both ADEs and complications after implementation.
Improving patients' intensive care admission through multidisciplinary simulation-based crisis resource management: a qualitative study.
https://psnet.ahrq.gov/issue/improving-patients-intensive-care-admission-through-multidisciplinary-simulation-based-crisis
Crisis (or crew) resource management (CRM) training focuses on improvement of non-technical skills such as communication, teamwork, and situational awareness. This quality improvement project consisted of simulation-based CRM training in the context of intensive care unit admission. Interviews with participants, conducted three months after the simulation, revealed several themes including reflections on patient safety. Participants described positive changes in workflow, professional standards, and smoother and controlled processes
Towards diagnostic excellence on academic ward teams: building a conceptual model of team dynamics in the diagnostic process.
https://psnet.ahrq.gov/issue/towards-diagnostic-excellence-academic-ward-teams-building-conceptual-model-team-dynamics
Teamwork is increasingly seen as an important component of diagnostic excellence. Through a systematic review and observations of team dynamics in a hospital medical ward, researchers identified three areas requiring additional research- (1) team structure, (2) contextual factors, and (3) emergent states (e.g., shared mental models).
Do not PIMP my nursing home ride! The impact of Potentially Inappropriate Medications Prescribing on residents' emergency care use.
https://psnet.ahrq.gov/issue/do-not-pimp-my-nursing-home-ride-impact-potentially-inappropriate-medications-prescribing
Potentially inappropriate prescribing in long-term care facilities increases the risk of adverse drug events and other adverse outcomes, including increased healthcare costs. Based on a secondary data analysis from the Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers (IDEM) randomized trial, this study found that increases in potentially inappropriate prescribing increased residents’ risk of going to the emergency room and increased total medication spending.
Do malpractice claim clinical case vignettes enhance diagnostic accuracy and acceptance in clinical reasoning education during GP training?
https://psnet.ahrq.gov/issue/do-malpractice-claim-clinical-case-vignettes-enhance-diagnostic-accuracy-and-acceptance
Clinical reasoning is an important component of medical education. In this study, first-year general practice residents concluded that diagnostic error cases, both with and without malpractice claim information, are equally effective for clinical reasoning education.
Are physician assistants able to correctly identify prescribing errors? A cross-sectional study.
https://psnet.ahrq.gov/issue/are-physician-assistants-able-correctly-identify-prescribing-errors-cross-sectional-study
A study conducted in 2011 concluded that pharmacy students identified more prescribing errors than their medical or nursing counterparts. This study replicates the 2011 study with first- and second-year physician assistant (PA) students. The results suggest PA students, regardless of year, identified prescribing errors at similar rates to medical and nursing students, although identification rates were low for all three student groups.
Pharmacy e-prescription dispensing before and after CancelRx implementation.
https://psnet.ahrq.gov/issue/pharmacy-e-prescription-dispensing-and-after-cancelrx-implementation
Pharmacy e-prescription dispensing before and after CancelRx implementation.
Pitts SI, Olson S, Yanek LR, et al. JAMA Intern Med. 2023;Epub Sep 5.
Previous research has found that CancelRx can improve communication between electronic health record (EHR) systems and pharmacy dispensing systems and increase successful medication discontinuation. This interrupted time series analysis assessed the impact of CancelRx implementation on successful discontinuation of medications e-prescribed in ambulatory healthcare settings. After CancelRx implementation, the proportion of e-prescriptions sold after discontinuation in the EHR decreased from 8.0% to 1.4%.
Preventing potential patient harm through clinical content interventions during oncology clinical trial implementation.
https://psnet.ahrq.gov/issue/preventing-potential-patient-harm-through-clinical-content-interventions-during-oncology
Preventing potential patient harm through clinical content interventions during oncology clinical trial implementation.
Loo VC, Kim S, Johnson LM, et al. J Patient Saf. 2023;Epub Aug 25.
Ensuring the safety of clinical trial participants is paramount to successful, meaningful clinical research. In this study, researchers examined 585 clinical trial documents and found that 17% included potential patient safety interventions (e.g., resolving medication dosing discrepancies). The authors suggest that clinical specialists’ review of study protocol documents could enhance patient safety during clinical trial conduct.
Ten years later, alarm fatigue is still a safety concern.
https://psnet.ahrq.gov/issue/ten-years-later-alarm-fatigue-still-safety-concern
Ten years later, alarm fatigue is still a safety concern.
Albanowski K, Burdick KJ, Bonafide CP, et al. AACN Adv Crit Care. 2023;34(3):189-197.
Alarm (or alert) fatigue occurs when clinicians ignore alarms, usually due to the majority being invalid or nonactionable, and thus fail to respond or respond more slowly to actionable alerts. The article describes the progress made in reducing nonactionable alarms and making actionable alarms more useful to responding clinicians. Clinical approaches include customization of alert parameters to reduce nonactionable alarms, while engineering solutions include reducing the volume or adjusting the tone of auditory alerts.
States Obtain Special Waivers to Help Unwinding Efforts
https://www.kff.org/policy-watch/states-obtain-special-waivers-to-help-unwinding-efforts/?utm_campaign=KFF-2023-The-Latest&utm_medium=email&_hsmi=275429267&_hsenc=p2ANqtz-_Q8MK3_1bPiArfpAem3S62aQUN4Xj45CIvX-UJiZapsGgloIO4Ht5oMb_1_O6MaPX_89tyWDu2z94igdN0Lv9_zK7o6g&utm_content=275429267&utm_source=hs_email
Yesterday, the Biden Administration announced that about 500,000 people, many of them children, will have Medicaid coverage restored after it found that 30 states were conducting renewals incorrectly. To date, more than 7.4 million adults and children have been disenrolled from Medicaid—73% for procedural reasons. Even before the announcement, many states have requested waivers to improve their unwinding efforts.
Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability
https://www.federalregister.gov/documents/2023/09/19/2023-20241/regulatory-considerations-for-prescription-drug-use-related-software-draft-guidance-for-industry?utm_medium=email&utm_source=govdelivery
The U.S. Food and Drug Administration issued a draft guidance for industry entitled, Regulatory Considerations for Prescription Drug-Use-Related Software. In response to comments received from FDA’s November 2018 proposed framework “Prescription Drug-Use-Related Software,” the agency is issuing the draft guidance to provide clarity to drug sponsors about how FDA will apply its drug labeling authorities to end-user output of prescription drug-use-related software, how FDA-required labeling will describe certain prescription drug-use-related software, and when and how to submit end-user output to FDA.
Digital health technologies used with prescription drugs can potentially offer new ways to help treat patients. Software, including those designed for mobile apps are used for health-related purposes, such as assisting patients with tracking their own drug ingestion, allowing health care practitioners to monitor patients taking a prescription drug, or providing information on how to use a drug. Digital health technologies may provide insight to patients, caregivers, and health care providers (collectively known as “end-users”) about a patient’s drug use. When drug sponsors develop digital health technologies, like prescription drug-use-related software for use with one or more of their drugs, FDA will apply its authorities according to an evidence-driven, risk-based framework consistent with existing drug labeling authorities
Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research OCTOBER 11, 2023
https://www.fda.gov/consumers/public-meetings-workshops-and-webinars/menopause-potential-impact-clinical-pharmacology-and-opportunities-future-research-10112023?utm_medium=email&utm_source=govdelivery
On October 11, 2023, the U.S. Food and Drug Administration (FDA) Office of Women’s Health (OWH), in collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), will host a free virtual public workshop entitled Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research. This workshop will discuss the current understanding of the impact of menopause on drug pharmacology and highlight the areas with the greatest need for further research and exploration.
This workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Each session will include a Q&A to respond to questions from attendees. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated drugs and biologics used by menopausal women for non-menopause-related indications. The discussion is intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD.
Workshop Objectives:
Examine the biological and physiological changes that occur during menopause
Discuss the current understanding of the impact of menopause on the PK, PD, and exposure-response relationships of FDA-regulated products used by menopausal women for non-menopause-related indications
Discuss whether the changes in drug absorption, distribution, metabolism, and elimination, if any, are specifically due to hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes)
Identify the research and data gaps regarding the impact of menopause on PK/PD, highlighting areas with the greatest need for further research and exploration
Date/Time of the Workshop:
Date: October 11, 2023
Time: 10:00 am-2:00 pm ET
Healthcare Industry Waste and Lifecycle Assessment
https://effectivehealthcare.ahrq.gov/products/lifecycle-assessment
The objective of this technical brief is to assess the current use of life cycle assessment frameworks in healthcare research and practice, understand the components of those frameworks, and assess gaps in research and practice to guide future directions.
Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD Repository Evidence Base
https://effectivehealthcare.ahrq.gov/products/ptsd-pharm-non-pharm-treatment-update/protocol
This review will update the literature base and build on the PTSD-Repository by adding newly-published studies, assessing risk of bias using the Cochrane risk-of-bias tool for randomized trials (RoB 2), and calculating standardized effect sizes.
(Section 944 (c) of the Public Health Service Act [42 U.S.C. 299c 3(c)] requires that information collected for research conducted or supported by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied unless they consent to the use of the information for another purpose.)
viernes, 22 de septiembre de 2023
Providing Hope During National Suicide Prevention Month
https://www.samhsa.gov/blog/providing-hope-during-national-suicide-prevention-month?utm_source=SAMHSA&utm_campaign=1ad3a066a6-EMAIL_CAMPAIGN_2023_09_19_02_32&utm_medium=email&utm_term=0_-1ad3a066a6-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
National Suicide Prevention Month is upon us again. This month represents hope: hope as we create more awareness around suicide; hope found in the resources available; and hope as we see the stigma around addressing suicide decrease. This month also can represent pain for those who have been touched by suicide. Whatever you are feeling this September, there are things you can do to create hope in your family and your community.
DAWN Drug-Related Emergency Department Visits Involving Suicide Attempts Short Report
https://www.samhsa.gov/data/sites/default/files/reports/rpt42709/ShortReport-EDVisits-SuicideAttempt.pdf?utm_source=SAMHSA&utm_campaign=2e186d1720-EMAIL_CAMPAIGN_2023_09_11_06_57&utm_medium=email&utm_term=0_-2e186d1720-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
The Drug Abuse Warning Network (DAWN) Drug-Related Emergency Department (ED) Visits Involving Suicide Attempts Short Report focuses on national estimates and characteristics of drug-related ED visits involving suicide attempts. There were 51 drug-related ED visits involving suicide attempts per 100,000 population. The short report identifies higher rates of suicide attempts among adolescent (age 12 to 17) females compared to adolescent males (231 per 100,000 vs. 66 per 100,00) and young adult (age 18 to 25) females compared to young adult males (145 per 100,000 vs. 73 per 100,000).
Coping With the Overdose Crisis as a Responder
https://mailchi.mp/health-emailupdates/dtac-bulletin-coping-with-the-overdose-as-a-responder?e=1162024328&utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
In 2021, more than 106,000 people in the United States died from a drug overdose. The U.S. overdose crisis has worsened over time, as illegally produced powerful synthetic opioids such as fentanyl and stimulants have flooded the market. For many first responders, this crisis has changed their jobs, adding stressful and otherwise adverse incidents to work that is often already stressful and challenging.
The following resources provide information regarding the effects of the overdose crisis on responders, highlighting the importance of community overdose prevention, and healthcare and emergency responder-specific mental health supports.
Grief and Loss in Substance Use Disorder Treatment — Webinar Friday, October 6, 2023 1 p.m. ET
https://attcnetwork.org/centers/pacific-southwest-attc/event/grief-and-loss-substance-use-disorder-treatment-sapc-ucla?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
The experience of grief and loss is complex in the substance use disorder treatment field and is rarely addressed. This lecture series event will describe the grieving process, phases of grief, and what happens when the process is interrupted. Traumatic grief, suicide, and the impact of COVID-19 and overdose deaths experienced in the treatment and recovery field will also be discussed. Helpful resources will be shared including how to support SUD treatment providers.
Xylazine and HIV in the Era of Synthetic Street Drugs — Webinar Friday, October 6, 2023 12 p.m. ET
https://opioidresponsenetwork.org/events/?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D#event=76915086;instance=20231006120000?popup=1
This presentation will review the history of US street drug markets since the early 1990s to explain the emergence of xylazine, fentanyl, and crystal methamphetamine in regional markets formerly dominated by heroin and cocaine. It will examine the relationship between each of these newly prevalent synthetic substances and describe what we know so far about their impact on HIV and related comorbidities.
Addressing Functional Cognition in Mental Health — Webinar Series Tuesday, October 3, 2023 1 p.m. ET
https://mhttcnetwork.org/centers/mountain-plains-mhttc/event/cognitive-impairment-and-influence-performance?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
This three-part series focuses on understanding the cognitive impairments associated with mental illness and the impact on participation and performance in everyday life. The series will provide an overview of cognitive impairment and its influence on participation, the evaluation process and intervention approaches. You may choose to attend one or more of the following sessions:
Tuesday, October 3, 2023 1 p.m. ET Session 1: Cognitive Impairment and Influence on Performance
Tuesday, October 10, 2023 1 p.m. ET Session 2: Evaluation of Cognitive Impairment
Tuesday, October 24, 2023 1 p.m. ET Session 3: Interventions for Cognitive Impairment
Contingency Management — Webinar Series Monday, October 2, 2023 2 p.m. ET
https://attcnetwork.org/centers/great-lakes-attc/event/contingency-management-october-2023?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
This training will assist participants in understanding the fundamentals of contingency management (CM) and developing a plan for CM implementation in their organization or clinical setting. Special attention will be paid to the use of CM as a primary treatment for stimulant use disorders. Additional dates in this series include:
Monday, October 9, 2023 2 p.m. ET
Monday, October 16, 2023 2 p.m. ET
Monday, October 23, 2023 2 p.m. ET
The Unintentional Harms of Weight Loss Recommendations — Webinar Thursday, September 28, 2023 2 p.m. ET
https://us06web.zoom.us/webinar/register/WN_SMXwIfImTmic1QowmXrYcw?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D#/registration
In this presentation, participants learn why weight loss recommendation by healthcare providers is harmful to patients. The evidence regarding the relationship between the recommendation of weight loss and weight stigma, weight cycling, eating disorders, and health will be presented. Evidence based practices of weight inclusive care will be presented and the complicated, nuanced topic of what to do when patients want to lose weight will be discussed.
Update on the U.S. Overdose Crisis: Which Drugs, Who is Dying, and How Do We Save Lives? — Webinar Wednesday, September 27, 2023 5 p.m. ET
https://opioidresponsenetwork.org/events/?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D#event=76915391;instance=20230927170000?popup=1
This webinar will review findings from national and local epidemiological studies on recent changes in U.S. overdose mortality. In recent years, overdose deaths increasingly involve polysubstance, namely opioids and stimulants. Fentanyl dominates almost everywhere, but the other specific drugs implicated vary regionally.
Celebrating Recovery: A Conversation with 2022 Recovery Innovation Challenge Winners — Webinar Wednesday, September 27, 2023 1 p.m. ET
https://mhttcnetwork.org/centers/global-mhttc/event/celebrating-recovery-conversation-2022-recovery-innovation-challenge?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
This hour-long event showcases the winners of the 2022 Recovery Innovation Challenge through a “talk-show” format. Up to five Challenge Winners will share their innovative strategies for recovery, lessons learned from implementation, and recommendations for replication in other communities.
Enhancing Care for People with Developmental Disabilities and Substance Use Disorders — Webinar Tuesday, September 26, 2023 1 p.m. ET
https://attcnetwork.org/centers/mountain-plains-attc/event/enhancing-care-people-developmental-disabilities-and-substance?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
Providing substance use disorder (SUD) treatment for people with developmental disabilities (DD) requires a flexible and individualized approach, yet there is a lack of available guidelines to inform best practices. This webinar will provide insights, practical suggestions, and expert tips for behavioral health professionals who work with people who have SUD and DD.
Overdose Grief, Loss, and Healing Supports — Interactive Webinar Monday, September 25, 2023 10 a.m. ET
https://attcnetwork.org/centers/northeast-caribbean-attc/event/overdose-grief-loss-and-healing-supports-92523-carccrpa-ce?utm_source=SAMHSA&utm_campaign=3315782ffc-EMAIL_CAMPAIGN_2023_09_20_06_25&utm_medium=email&utm_term=0_-3315782ffc-%5BLIST_EMAIL_ID%5D
How do we respond to the emotional and psychological toll the overdose of a client or resident has on professional caregivers and other peers? This interactive session will review grief challenges that addiction professionals experience when clients and residents suffer a recurrence and succumb to an overdose. Content will review the behavioral, physical, and psychological responses to grief, coping strategies, and provider self-care. Discussion will also review agency prevention/postvention activities that can help support staff and residents healing from overdose loss.
jueves, 21 de septiembre de 2023
SAMHSA Releases New Data on Recovery from Substance Use and Mental Health Problems Among Adults in the United States
https://www.samhsa.gov/newsroom/press-announcements/20230920/new-data-recovery-from-substance-use-mental-health-problems-among-adults-in-united-states?utm_source=SAMHSA&utm_campaign=3aa79b9f89-EMAIL_CAMPAIGN_2023_09_20_01_42&utm_medium=email&utm_term=0_-3aa79b9f89-%5BLIST_EMAIL_ID%5D
The Substance Abuse and Mental Health Services Administration (SAMHSA) today released Recovery from Substance Use and Mental Health Problems Among Adults in the United States, a new report that provides data on the adults in recovery from their substance use and/or mental health problem and provides policy recommendations identified as supporting recovery.
Using data from the 2021 National Survey on Drug Use and Health (NSDUH), this report shows that 70 million adults aged 18 or older perceived that they ever had a substance use and/or mental health problem. For substance use specifically, of the 29.0 million adults who perceived that they ever had a substance use problem, 72.2% (or 20.9 million) considered themselves to be in recovery or to have recovered from their drug or alcohol use problem. For mental health, of the 58.7 million adults who perceived they ever had a mental health problem, 66.5% (or 38.8 million) considered themselves to be in recovery or to have recovered from their mental health problem.
“SAMHSA is committed to continuing to provide valuable, relevant data that helps inform, guide and support life in recovery,” said Miriam E. Delphin-Rittmon, Ph.D., U.S. Department of Health and Human Services Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “With a whole-health approach, recovery is real and possible for all those impacted by mental health and substance use conditions.”
Guide to Integrate Patient-Generated Digital Health Data into Electronic Health Records in Ambulatory Care Settings
https://digital.ahrq.gov/health-it-tools-and-resources/patient-generated-health-data-i-patient-reported-outcomes/practical-guide
About AHRQ's Digital Healthcare Research ProgramAbout AHRQ's Digital Healthcare Research Program
https://digital.ahrq.gov/
The National Action Alliance To Advance Patient Safety
The National Action Alliance To Advance Patient Safety: The Agency for Healthcare Research and Quality (AHRQ), on behalf of the Department of Health and Human Services (HHS), has established the National Action Alliance to Advance Patient Safety as a public-private collaboration to improve both patient and workforce safety. The National Action Alliance is a partnership between HHS and its Federal agencies and private stakeholders, including healthcare systems, clinicians, allied health professionals, patients, families, caregivers, professional societies, patient and workforce safety advocates, the digital healthcare sector, health services researchers, employers, and payors interested in recommitting our Nation to advancing patient and workforce safety to move toward zero harm in healthcare.
Upcoming Webinar: Learning Health System’s Potential To Reduce Patient Harms. A webinar on Sept. 26 from 2 to 3 p.m. ET
Upcoming Webinar
Learning Health System’s Potential To Reduce Patient Harms. A webinar on Sept. 26 from 2 to 3 p.m. ET will highlight the Veterans Health Administration’s (VHA) Journey to High Reliability: Advancing Toward Zero Harm and Becoming a Learning Health System. The webinar is part of a series sponsored by the AHRQ-led National Action Alliance to Advance Patient Safety, a public–private collaboration to support healthcare delivery systems’ move toward zero harm.
Intensive care unit critical incident analysis as an objective tool to select content for a simulation curriculum. September 13, 2023
https://psnet.ahrq.gov/issue/intensive-care-unit-critical-incident-analysis-objective-tool-select-content-simulation
Intensive care units (ICUs) are complex care environments at high risk for medical errors. In this retrospective study, researchers identified the occurrence of common ICU scenarios and skills during code blue events and measured trainees’ self-reported confidence in these skills. The analysis found that more than 25% of trainees reported low levels of confidence in three scenarios – familiarity with the advanced life support trolley, electrocardiogram strip interpretation, and operation of an external defibrillator. This process of integrating critical incident data with trainee self-assessment can be generalized to other clinical scenarios to create targeted education and simulation curriculum.
Patient and family contributions to improve the diagnostic process through the OurDX electronic health record tool: a mixed method analysis. September 13, 2023
https://psnet.ahrq.gov/issue/patient-and-family-contributions-improve-diagnostic-process-through-ourdx-electronic-health
Patient and family engagement is essential to effective and safe diagnosis. OurDX is a previsit online engagement tool to help identify opportunities to improve diagnostic safety in patients and families living with chronic conditions. In this study, researchers implemented OurDX in specialty and primary care clinics at two academic healthcare organizations and examined the potential safety issues and whether patient/family contributions were integrated into the post-visit notes. Qualitative analysis of 450 OurDX reports found that participants contributed important information about the diagnostic process. Participants with diagnostic concerns were more likely to raise concerns about the diagnostic process (e.g., access barriers, problems with tests/referrals, communication breakdowns), which may represent diagnostic blind spots.
Physician perspectives on responding to clinician-perpetuated interpersonal racism against Black patients with serious illness. September 13, 2023
https://psnet.ahrq.gov/issue/physician-perspectives-responding-clinician-perpetuated-interpersonal-racism-against-black
Structural racism continues to perpetuate health disparities. As part of their study on how black patients with serious illness experience racism from providers, researchers conducted interviews with 21 providers to understand ways they address anti-Black racism in their practice. Providers felt unprepared to address racism with their patients, wanted to provide tools for patients to bring up their experiences while also acknowledging the additional burden this would place on Black patients, and thought patient- and provider-facing programs could facilitate discussions. Additionally, despite extensive research on the negative impacts of structural racism on health, participants cited the need for more data.
Strategies for Improving Clinician Psychological Safety in Reporting and Discussing Diagnostic Error
Strategies for Improving Clinician Psychological Safety in Reporting and Discussing Diagnostic Error: One of the best ways to collect information about diagnostic errors is through self-reporting by patients and clinicians. Successful approaches to learn from diagnostic quality and develop strategies to reduce harm from diagnostic failure depend on two workplace characteristics: psychological safety and organizational safety culture. Both concepts are explored in this issue brief.
Digital Healthcare Research
https://digital.ahrq.gov/program-overview/research-reports/2022-year-review
The annual report emphasizes the program’s efforts to identify digital tools and resources to improve health outcomes, reduce medical costs and create a more efficient healthcare system. Showcased in the report are AHRQ-funded studies that focus on helping patients, providers and health systems make more informed decisions about care options.
AHRQ’s Digital Healthcare Research Program Is Identifying the Technology To Advance Care Quality, Safety, and Effectiveness
AHRQ’s Digital Healthcare Research Program Is Identifying the Technology To Advance Care Quality, Safety, and Effectiveness: AHRQ's recently released 2022 year in review, Improving Healthcare Through AHRQ’s Digital Healthcare Research, showcases several studies that focus on helping patients, providers, and health systems make more informed decisions about care options. We also note several projects that proved easily scalable across systems or that identified ways to improve uptake.
For World Patient Safety Day 2023, AHRQ Recognizes the Imperative of Engaging Patients in Their Care
For World Patient Safety Day 2023, AHRQ Recognizes the Imperative of Engaging Patients in Their Care
For World Patient Safety Day, Recognizing the Imperative of Engaging Patients in Their Care. AHRQ’s support of World Patient Safety Day 2023 and the agency’s ongoing efforts to emphasize patient safety as a core value is featured in blog post by Director Robert Otto Valdez, Ph.D., M.H.S.A. This year’s Sept. 17 observance recognized the crucial role played by patients, families and caregivers in receiving the safest possible healthcare. Dr. Valdez highlights numerous AHRQ resources for helping patients, families, caregivers and health professionals work together to improve care.
What’s Wrong With This Picture? NIST Face Analysis Program Helps to Find Answers
https://www.nist.gov/news-events/news/2023/09/whats-wrong-picture-nist-face-analysis-program-helps-find-answers
NIST Evaluates Face Recognition Software’s Accuracy for Flight Boarding
Agency’s new test concerns checking in passengers and documenting their exit from a country.
https://www.nist.gov/news-events/news/2021/07/nist-evaluates-face-recognition-softwares-accuracy-flight-boarding
AHRQ’s Digital Healthcare Research Program Is Identifying the Technology To Advance Care Quality, Safety, and Effectiveness
AHRQ’s Digital Healthcare Research Program Is Identifying the Technology To Advance Care Quality, Safety, and Effectiveness: AHRQ's recently released 2022 year in review, Improving Healthcare Through AHRQ’s Digital Healthcare Research, showcases several studies that focus on helping patients, providers, and health systems make more informed decisions about care options. We also note several projects that proved easily scalable across systems or that identified ways to improve uptake.
Two-Day Virtual Public Meeting: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies
During the COVID-19 public health emergency (PHE), the U.S. Food and Drug Administration provided recommendations to mitigate the disruption of clinical studies.
Join us for a virtual public meeting on October 18 and 19, 2023, in collaboration with the Clinical Trials Transformation Initiative to discuss these recommendations and to discuss advanced planning approaches to mitigate the disruption of clinical studies during disasters and PHEs.
The public meeting will take place from 10 a.m. to 1:30 p.m. ET on both days and is free to attend. The meeting agenda can be viewed here.
https://duke.zoom.us/meeting/register/tJAvcO-oqD4vE9Ov1Vv-A3SoItVhL7Rhg66T?utm_medium=email&utm_source=govdelivery#/registration
The two-day virtual public meeting will include presentations, panels and discussion opportunities led by FDA, pharmaceutical and medical device industries, academia, research study teams, patients, patient advocacy groups and other federal agencies, who will share their experiences and best practices including approaches they used to effectively navigate disruptions to clinical studies during the COVID-19 PHE.
This public meeting fulfills a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).
miércoles, 20 de septiembre de 2023
AHRQ Challenge on Designing the Optimal Future State of CDS Connect
AHRQ Challenge on Designing the Optimal Future State of CDS Connect: The purpose of this Challenge Competition is to solicit ideas on the future state of CDS Connect.
New Challenge Competition Offers Prizes for Ideas on Advancing AHRQ’s CDS Connect
https://cds.ahrq.gov/index.php/cdsconnect
The CDS Connect Project is a freely available web-based platform that enables the clinical decision support (CDS) community to identify evidence-based care, translate and codify information into an interoperable health IT standard, and leverage tooling to promote a collaborative model of CDS development.
FDA Drug Topics: Regulatory Framework for Human Drug Compounding - September 26, 2023 Tuesday, September 26, 2023 2:00:00 PM ART - 3:15:00 PM ART
https://collaborationcqpub1.fda.gov/content/connect/c1/7/en/events/event/shared/94630851/event_registration.html?_charset_=utf-8&connect-session=breezbreez3no7tpeydqqet4fa&sco-id=262625629&utm_medium=email&utm_source=govdelivery
Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. Compounded drugs serve an important medical need for certain populations who cannot be treated with FDA-approved medications, including pediatric patients or patients with allergies requiring drugs made without certain excipients. Although compounded drugs can serve an important medical need for certain patients, they also present a risk. FDA's compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to drugs compounded pursuant to provisions established in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning Human Drug Compounding. This presentation provides an overview of human drug compounding and its regulatory framework, differentiates drug compounding from the FDA new drug approval process, describes the bulk drug substance evaluation process, and provides examples.
AHRQ’s Digital Healthcare Research Program Is Identifying the Technology To Advance Care Quality, Safety, and Effectiveness
AHRQ’s Digital Healthcare Research Program Is Identifying the Technology To Advance Care Quality, Safety, and Effectiveness: AHRQ's recently released 2022 year in review, Improving Healthcare Through AHRQ’s Digital Healthcare Research, showcases several studies that focus on helping patients, providers, and health systems make more informed decisions about care options. We also note several projects that proved easily scalable across systems or that identified ways to improve uptake.
The global launch of Women, power and cancer: A Lancet Commission on Women miércoles, 27 de septiembre de 2023 9:00 - 11:30 (UTC-03:00) Ciudad de Buenos Aires
https://iheid.webex.com/webappng/sites/iheid/meeting/register/00eddfcb4e684ad9b5c5a37273c57944?ticket=4832534b00000006e5fceeeb0f51bd0707ad838286b4f27f1067c7d3abf9be7a161c7cf3d342e042×tamp=1695215189458&RGID=r76ba5e10ef0689915b0e83d01e77a662
We are pleased to invite you to the virtual launch of Women, power and cancer: A Lancet Commission, on Sep 27, 2023, at 13:00 BST/11:00 EDT. Attendance is free, and you can register to attend the session here.
Women, power, and cancer: A Lancet Commission applies an intersectional feminist approach to investigate, expose, and challenge the current imbalance of power in relation to cancer. The report calls for sex and gender to be included in all cancer-related policies and guidelines, making them responsive to the needs and aspirations of all women, whether they be cancer patients, care providers, researchers, or advocates.
With opening remarks from Vania Wisdom, Executive Editor of The Lancet and Oncology Ambassador, and a panel discussion moderated by Richard Horton, Editor-in-Chief of The Lancet, join us as the authors discuss key findings and recommendations from the Commission.
martes, 19 de septiembre de 2023
Dana-Farber deal highlights a surprising trend: New cancer centers are in vogue Tara Bannow By Tara Bannow Sept. 15, 2023
https://www.statnews.com/2023/09/15/dana-farber-deal-cancer-centers/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=274613026&_hsenc=p2ANqtz-_HvosqWhDGpHEjMj2WlPZWfUzEIvB_oZR5g8f_qhSPbJe5HEeHlJ6Mfqjl85hv8521uzpra2gwm5-KNTEXI2ykBSJYhg&utm_content=274613024&utm_source=hs_email
There’s little appetite to build general acute-care hospitals these days, especially as their financial outlook dims and more services move outpatient. But as the Dana-Farber Cancer Institute's plan to build a new cancer hospital with Beth Israel Deaconess shows, cancer centers are the exception to the rule.
This year alone, at least six prominent cancer centers have announced plans to build new hospitals in cities like New York, Chicago, and Austin. Experts say the wave is largely driven by the advent of targeted precision therapies like CAR-T, which are still mostly delivered in hospitals. In Boston, leaders with Dana-Farber and Beth Israel Deaconess acknowledged a lot of cancer care is moving into outpatient settings, but said there still aren’t enough beds to care for all the cancer patients who need care. STAT's Tara Bannow has more.
Public policy and health in the USA miniseries: should investors own healthcare?
Lancet Webinars | Public policy and health in the USA miniseries: should investors own healthcare?
Public policy and health in the USA miniseries: should investors own healthcare?
Tues, Sept 26, 2023
14:00 EDT / 19:00 BST
https://event.on24.com/wcc/r/4261292/F83D33EB8BF67FD27D747E69F489D5E3?partnerref=hubspot_email_usinvestorshealthcare23_registration2&utm_campaign=usinvestorshealthcare23&utm_medium=email&_hsenc=p2ANqtz-8MfbvzLZmM7PIG1KrjdTb6bAIAlJbbssgFViuQREIKVOPZ_pZAOaRrmtTE12jX_NuKVbEcyDebRu45uSoVV78aazklCA&_hsmi=274745909&utm_content=271084668&utm_source=hs_email&hsCtaTracking=0edcc6e7-b051-4115-83e3-19a69116e8a8%7C3e5adfc7-394b-4754-94c2-b7b144a8d8b9
Accreditation Scheme for Conformity Assessment (ASCA)Accreditation Scheme for Conformity Assessment (ASCA)
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca?utm_medium=email&utm_source=govdelivery
The Accreditation Scheme for Conformity Assessment (ASCA) is a voluntary accreditation program that capitalizes on the increasingly prominent role of consensus standards in regulatory science.
Effective today, the U.S. Food and Drug Administration’s ASCA program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V).
The ASCA program’s goals are to:
Streamline conformity assessment in medical device submissions
Enhance the FDA’s confidence in test methods and results
Decrease the need for additional information related to conformance with a standard
Promote consistency, predictability, and efficiency in medical device review
Serve as a least burdensome approach to conformity assessment
lunes, 18 de septiembre de 2023
CAHPS Research Meetings: Patient Experience, Patient Safety, and Provider Well-Being: Associations and Paths for Quality Improvement (October 19, 2023)
CAHPS Research Meetings: AHRQ occasionally hosts research meetings that bring together researchers, subject matter experts and key stakeholders to focus on specific topics of interest related to CAHPS surveys.
FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors OCTOBER 16, 2023
https://www.fda.gov/news-events/fdacder-office-clinical-pharmacology-and-international-society-pharmacometrics-isop-public-workshop?utm_medium=email&utm_source=govdelivery
On October 16, 2023, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP) in collaboration with the International Society of Pharmacometrics (ISoP) will hold a hybrid public workshop entitled Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors. The workshop will examine how various intrinsic and extrinsic factors can influence the investigation and selection of dosages during clinical development.
Workshop Objectives:
To discuss best practices and methods to incorporate quantitative methods into the clinical development of oncologic products as a means to support dosage optimization that has been strongly advocated for in recent engagements
To describe the impact of dosage exploration on the benefit/risk assessment for oncologic products and highlight ongoing efforts from regulatory agencies, academic centers, and industry to shift current practices used to select dosages for investigation in clinical trials and identify the recommended dosage for marketing applications and labeling
To discuss the role of model-based approaches in investigating how various intrinsic and extrinsic factors can influence the investigation and selection of dosages during clinical development
Date/Time of the Workshop:
Date: October 16, 2023
Time: 10:00am-4:30pm ET
The primary audience includes clinical pharmacologists, pharmacometricians, pharmacologists/toxicologists, clinicians/healthcare providers, statisticians, patients, and patient advocates. This hybrid event is open to the public with no cost to attend; however, registration is required. More information about this event can be found here.
Pharmacovigilance against racial capitalism The Lancet Vol. 402 Published: September 09, 2023
https://www.thelancet.com/equity-diversity-inclusion?dgcid=hubspot_update_feature_updatealerts_lanplh&utm_campaign=update-lanplh&utm_medium=email&_hsmi=274609108&_hsenc=p2ANqtz-_M4bB3AF4o2TGa5a3yUSpNnIpHNV6LQemGzHJXRtwqc7hmz5yGa7LoRgQaBXhD0qOwbR53AOGSsfRNjphWqrE9E_vGLg&utm_content=274412428&utm_source=hs_email
Pharmacovigilance against racial capitalism
Harriet A Washington
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01848-2/fulltext
domingo, 17 de septiembre de 2023
In search of an international multidimensional action plan for second victim support: a narrative review.
Clinicians who are involved in a patient safety incident can experience psychological harm. This literature review of 104 studies identified five levels of support that can be provided to healthcare workers after a patient safety incident – (1) prevention, (2) self-care of individuals and/or teams, (3) support by peers and triage, (4) structured professional support, and (5) structured clinical support.
https://psnet.ahrq.gov/issue/search-international-multidimensional-action-plan-second-victim-support-narrative-review
Advancing Patient Care Excellence through Human Factors Engineering.
https://psnet.ahrq.gov/issue/advancing-patient-care-excellence-through-human-factors-engineering
Human factors engineering (HFE) is a core approach to improving the reliability and safety of complex practice. This conference will provide direction in understanding how to proactively define risks and design processes to reduce the potential for failure.
Complications and Errors in Periodontal and Implant Therapy.
https://psnet.ahrq.gov/issue/complications-and-errors-periodontal-and-implant-therapy
Patient safety in dentistry shares common challenges with medicine and their emergence in a distinct care environment. This special issue covers a range of adverse events and treatment mistakes associated with periodontal procedures. Topics examined include human factors, implant placement and methodologic bias.
A Transformational Effort on Patient Safety.
https://psnet.ahrq.gov/issue/transformational-effort-patient-safety
The President’s Council of Advisors on Science and Technology brings together topic experts to summarize important issues for the consideration of the President of the United States. This report introduces the persistent problem of unsafe care and recommends a federal leadership entity, application of evidence-based solutions, true patient partnership and research funding as avenues to achieve stable improvement.
Pediatric Diagnostic Safety: State of the Science and Future Directions.
https://psnet.ahrq.gov/issue/pediatric-diagnostic-safety-state-science-and-future-directions
Unique challenges accompany efforts to study and reduce diagnostic error in children. This issue brief discusses addressing obstacles associated with testing and care access limitations that affect diagnosis across a variety of pediatric care environments. It also provides recommendations for building capacity to advance pediatric diagnostic safety. This issue brief is part of a series on diagnostic safety.
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