sábado, 30 de septiembre de 2023
Disclosure of Medical Errors.
Disclosure of Medical Errors.
https://psnet.ahrq.gov/issue/disclosure-medical-errors
Irving, TX: American College of Emergency Physicians; 2023.
Error disclosure is difficult yet important for patient and clinician psychological healing. This statement provides guidance to address barriers to emergency physician disclosure of errors that took place in the emergency room. Recommendations for improvement include the development of organizational policies that support error reporting, disclosure procedures, and disclosure communication training.
Human Factors Workshop: A Systems Approach to Patient Safety.
Medstar Health. Lyon Village Community House, Arlington, VA, October 19 - 20, 2023.
https://psnet.ahrq.gov/issue/human-factors-workshop-systems-approach-patient-safety
Human factors strategies are a core approach to mitigating the impact of human error in medicine. This workshop will provide a safety science context to the application of human factors engineering to health care. The complementary approaches will be infused with discussions on event review and proactive safety improvement efforts.
Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop
https://www.federalregister.gov/documents/2023/09/26/2023-20903/advancing-the-development-of-pediatric-therapeutics-on-drug-dosing-in-pediatric-patients-with-renal?utm_medium=email&utm_source=govdelivery#:~:text=The%20main%20objective%20of%20the,and%20explore%20scientifically%20supported%20approaches
FDA is announcing the public workshop “Advancing the Development of Pediatric Therapeutics (ADEPT 8) Workshop on Drug Dosing in Pediatric Patients with Renal Impairment.”
The meeting will be held on Thursday, November 30 and Friday, December 1 from 9 a.m. to 5 p.m. ET. This workshop will be both on-site on the FDA’s White Oak Campus (Silver Spring, MD) and virtually.
The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current model for dosing. The workshop will allow time for open discussion and will specifically focus on measurements of renal function, extrapolation of adult data, and approaches to generating clinical trial data to assess the impact of renal impairment on the movement of drugs within the body in pediatric patients.
All attendees must register.
https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407?utm_medium=email&utm_source=govdelivery
Delayed Evaluation of Abdominal Pain in an Elderly Patient. Liliya Klimkiv, MD, Garth Utter, MD, MSc, and David K. Barnes, MD | September 27, 2023
Delayed Evaluation of Abdominal Pain in an Elderly Patient.
Liliya Klimkiv, MD, Garth Utter, MD, MSc, and David K. Barnes, MD | September 27, 2023
https://psnet.ahrq.gov/web-mm/delayed-evaluation-abdominal-pain-elderly-patient
This WebM&M Case describes an older adult patient with generalized abdominal pain who was eventually diagnosed with inoperable bowel necrosis. Although she appeared well and had stable vital signs, triage was delayed due to emergency department (ED) crowding, which is usually a result of hospital crowding. She was under-triaged and waited three hours before any diagnostic studies or interventions commenced. Once she was placed on a hallway gurney laboratory and imaging studies proceeded hastily. Catastrophic bowel necrosis was eventually identified, yet she was not moved to a standard ED treatment bed for another 25 minutes. Despite aggressive resuscitation, the surgeon determined that operative intervention was futile, and the patient died a short time later. The commentary highlights how hospital crowding and ED boarding can lead to delayed triage and inefficient ED throughput, which compromises patient safety and summarizes approaches to improving ED triage and throughput.
A Double “Never Event”: Wrong Patient and Wrong Side. Commentary by Alyssa Bellini, MD and Edgardo S Salcedo, MD, FACS | September 27, 2023
A Double “Never Event”: Wrong Patient and Wrong Side.
Commentary by Alyssa Bellini, MD and Edgardo S Salcedo, MD, FACS | September 27, 2023
https://psnet.ahrq.gov/web-mm/double-never-event-wrong-patient-and-wrong-side
This WebM&M Case highlights two “never events” involving the same patient. A first-year orthopedic surgery resident was consulted to aspirate fluid from the left ankle of a patient in the intensive care unit. The resident, accompanied by a second resident, approached the wrong patient and inserted the needle into the patient’s right ankle. At this point, a third resident entered the room and stated that it was the incorrect patient. The commentary highlights the importance of a proper time out and approaches to improve communication among all members of the care team.
Insulin Administration: Pen vs Vial – Similar, but Not Interchangeable Hana Camarillo, PharmD, BCACP, CDCES | September 27, 2023
Insulin Administration: Pen vs Vial – Similar, but Not Interchangeable
Hana Camarillo, PharmD, BCACP, CDCES | September 27, 2023
https://psnet.ahrq.gov/web-mm/insulin-administration-pen-vs-vial-similar-not-interchangeable
In this WebM&M Case a 14-year-old girl was admitted to the hospital with a new diagnosis of type 1 diabetes mellitus without ketoacidosis. Before discharge, medications intended for home use were delivered to the patient’s bedside, but the resident physician noticed a discrepancy. An insulin pen and pen needles had been ordered, but an insulin vial and extra insulin syringes were delivered. Neither the patient nor the parents had received education on how to draw up and administer insulin using a vial and syringe. The pharmacy staff reported that the insulin pen was out of stock, so the insulin vial was substituted because it contained the same active ingredient. The insulin product switch was declined, and another pharmacy was contacted to provide the insulin pen, which was delivered to the patient’s bedside the following day. The commentary summarizes the patient safety risks associated with drug shortages, drug interoperability standards, and the importance of clear communication between members of the care team if alternative therapies need to be considered.
Walking Out of a Hospital After Attempted Suicide. Commentary by James A. Bourgeois, OD, MD and Glen Xiong, MD | September 27, 2023
Walking Out of a Hospital After Attempted Suicide.
Commentary by James A. Bourgeois, OD, MD and Glen Xiong, MD | September 27, 2023
https://psnet.ahrq.gov/web-mm/walking-out-hospital-after-attempted-suicide
In this WebM&M Case a 42-year-old man with a history of posttraumatic stress disorder (PTSD), alcohol use disorder and anxiety disorder, was seen in the emergency department (ED) after a high-risk suicide attempt by hanging. The patient was agitated and attempted to escape from the ED while on an involuntary psychiatric commitment. The ED staff treated him as a “routine boarder” awaiting an inpatient bed, with insufficiently robust behavioral monitoring. He eloped, then further complications resulted when law enforcement personnel were involved in his psychiatric emergency and when correctional mental health services were not available in a timely manner. The commentary discusses the importance of assessing for hypoxia-associated delirium and/or hippocampal damage/amnesia after any strangulation and the need for inpatient psychiatric hospitalization after emergency stabilization and management of delirium.
A Missed Bowel Perforation –the Importance of Diagnostic Reasoning Leah Timbag, MD, MPH, Voltaire R. Sinigayan, MD, and Mithu Molla, MD, MBA | September 27, 2023
A Missed Bowel Perforation –the Importance of Diagnostic Reasoning
Leah Timbag, MD, MPH, Voltaire R. Sinigayan, MD, and Mithu Molla, MD, MBA | September 27, 2023
https://psnet.ahrq.gov/web-mm/missed-bowel-perforation-importance-diagnostic-reasoning
This WebM&M Spotlight Case with CE/MOC, describes the failure to identify a brewing abdominal process, which over the span of hours led to fulminant sepsis with rapid clinical deterioration and eventual demise. The patient’s ascitic fluid cultures and autopsy findings confirmed bowel perforation, but this diagnosis was never explicitly considered. The commentary discusses the importance of early identification of sepsis, the role of biomarkers and risk scores in conjunction with bedside examinations to assess patients with suspected sepsis, and approaches to improve the prognosis of patients in septic shock, such as protocolized sepsis bundles.
Advancing the Impact of Consumer Experience of Care Measurement: What’s Next?
Advancing the Impact of Consumer Experience of Care Measurement: What’s Next?: AHRQ’s National Advisory Council (NAC) asked experts to brief them about the current state of the science of consumer experience measurement with an eye toward what’s next. This blog features are some key takeaways from their discussion at the July 2023 meeting.
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” OCTOBER 2023
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
OCTOBER 2023
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-prescription-drug-and-biological-products-labeling-dosing-based-weight-or-body-surface-area?utm_medium=email&utm_source=govdelivery
Today, the U.S. Food and Drug Administration issued a final guidance titled, “Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – “Dose Banding.” This final guidance provides recommendations to assist applicants in incorporating information into human prescription drug labeling on how to dose patients with drugs that have weight- or body surface area-based doses when using ready-to-use containers offering a range of strengths (for example, as provided in pre-mixed infusion bags).
The recommendations outlined in the final guidance are intended for applicants seeking to include information in labeling under a supplement to an existing new drug application (NDA) or 351(a) biologics license application (BLA) or for an original NDA or 351(a) BLA.
viernes, 29 de septiembre de 2023
Effects of work shift or shift length on radiation safety perception
Effects of work shift or shift length on radiation safety perception
https://psnet.ahrq.gov/issue/effects-work-shift-or-shift-length-radiation-safety-perception
Clinical triggers and vital signs influencing crisis acknowledgment and calls for help by anesthesiologists: a simulation-based observational study. September 27, 2023
Clinical triggers and vital signs influencing crisis acknowledgment and calls for help by anesthesiologists: a simulation-based observational study.
September 27, 2023
https://psnet.ahrq.gov/issue/clinical-triggers-and-vital-signs-influencing-crisis-acknowledgment-and-calls-help
Making a move: using simulation to identify latent safety threats before the care of injured patients in a new physical space. September 27, 2023
Making a move: using simulation to identify latent safety threats before the care of injured patients in a new physical space.
September 27, 2023
https://psnet.ahrq.gov/issue/making-move-using-simulation-identify-latent-safety-threats-care-injured-patients-new
Kotagal M, Falcone RA, Daugherty M, et al. J Trauma Acute Care Surg. 2023;95(3):426-431.
Simulation can be used to identify latent safety threats (LSTs) when implementing new workflows or care locations. In this study, simulation scenarios were used to identify LSTs associated with the opening of a new emergency department and critical care area. The 118 identified threats involved equipment, structural or layout issues, resource concerns, and knowledge gaps. Failure mode and effects analysis informed an action plan to mitigate these threats.
The influence of hospital leadership support on burnout, psychological safety, and safety climate for US infection preventionists during the coronavirus disease 2019 (COVID-19) pandemic. September 27, 2023
The influence of hospital leadership support on burnout, psychological safety, and safety climate for US infection preventionists during the coronavirus disease 2019 (COVID-19) pandemic.
September 27, 2023
https://psnet.ahrq.gov/issue/influence-hospital-leadership-support-burnout-psychological-safety-and-safety-climate-us
Gilmartin HM, Saint S, Ratz D, et al. Infect Control Hosp Epidemiol. 2023;Epub Sep 13.
Burnout has been reported across numerous healthcare settings and disciplines during the COVID-19 pandemic. Among US hospital infection preventionists surveyed in this study, nearly half reported feeling burnt out, but strong leadership support was associated with lower rates of burnout. Leadership support was also associated with psychological safety and a stronger safety climate.
Scaling up a diagnostic pause at the ICU-to-ward transition: an exploration of barriers and facilitators to implementation of the ICU-PAUSE handoff tool. September 27, 2023
https://psnet.ahrq.gov/issue/scaling-diagnostic-pause-icu-ward-transition-exploration-barriers-and-facilitators
Scaling up a diagnostic pause at the ICU-to-ward transition: an exploration of barriers and facilitators to implementation of the ICU-PAUSE handoff tool.
Cornell EG, Harris E, McCune E, et al. Diagnosis (Berl). 2023;Epub Aug 21.
Structured handoffs can improve the quality of patient information passed from one care team to another. This article describes intensivists' perspectives on a potential handoff tool (ICU-PAUSE) for handoff from the intensive care unit (ICU) to medical ward. They described the usefulness of a structured clinical note, especially regarding pending tests and the status of high-risk medications. Several barriers were also discussed, such as the frequent training required for residents who rotate in and out of the ICU and potential duplication of the daily chart note.
FDA and the Center for Research on Complex Generics (CRCG) are hosting a public workshop on December 7-8, 2023: Characterization of Complex Excipients and Formulations Workshop Date and Time: December 7, 8:30 a.m. – 5:40 p.m. EST December 8, 8:30 a.m. – 3:15 p.m. EST
FDA and the Center for Research on Complex Generics (CRCG) are hosting a public workshop on December 7-8, 2023: Characterization of Complex Excipients and Formulations
Workshop Date and Time:
December 7, 8:30 a.m. – 5:40 p.m. EST
December 8, 8:30 a.m. – 3:15 p.m. EST
https://www.complexgenerics.org/characterization-of-complex-excipients-and-formulations/?utm_medium=email&utm_source=govdelivery
Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop
FDA Announced Public Workshop on ADEPT 8 Pediatric Renal Impairment - Drug Information Update
https://www.federalregister.gov/documents/2023/09/26/2023-20903/advancing-the-development-of-pediatric-therapeutics-on-drug-dosing-in-pediatric-patients-with-renal?utm_medium=email&utm_source=govdelivery#:~:text=The%20main%20objective%20of%20the,and%20explore%20scientifically%20supported%20approaches
FDA announced the public workshop “Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients with Renal Impairment.”
The meeting will be held on Thursday, November 30 and Friday, December 1 from 9 a.m. to 5 p.m. ET. This workshop will be both on-site on the FDA’s White Oak Campus (Silver Spring, MD) and virtually.
The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current model for dosing. The workshop will allow time for open discussion and will specifically focus on measurements of renal function, extrapolation of adult data, and approaches to generating clinical trial data to assess the impact of renal impairment on the movement of drugs within the body in pediatric patients.
All attendees must register. FDA announced the public workshop “Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients with Renal Impairment.”
The meeting will be held on Thursday, November 30 and Friday, December 1 from 9 a.m. to 5 p.m. ET. This workshop will be both on-site on the FDA’s White Oak Campus (Silver Spring, MD) and virtually.
The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current model for dosing. The workshop will allow time for open discussion and will specifically focus on measurements of renal function, extrapolation of adult data, and approaches to generating clinical trial data to assess the impact of renal impairment on the movement of drugs within the body in pediatric patients.
All attendees must register.
https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407?utm_medium=email&utm_source=govdelivery
Drug Trials Snapshots: KORSUVA (Difelikefalin)
Drug Trials Snapshots: KORSUVA (Difelikefalin)
KORSUVA is an opioid receptor agonist for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-korsuva
jueves, 28 de septiembre de 2023
Conversations on Cancer: Living with Metastatic Breast Cancer OCTOBER 19, 2023
Conversations on Cancer: Living with Metastatic Breast Cancer
OCTOBER 19, 2023
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/conversations-cancer-living-metastatic-breast-cancer-10192023?utm_medium=email&utm_source=govdelivery
Background:
FDA Oncology Center of Excellence (OCE) in conjunction with the European Medicines Agency (EMA) presents a Conversations on Cancer public panel discussion October 19, 2023, addressing the experience of living with metastatic breast cancer.
Approximately 10-30% of breast cancer patients in the world are living with advanced stage or metastatic disease. With improvements in treatments and more options for therapies, many of these patients are living for years with their cancer. Cancer survivorship has become an issue of growing importance since the Institute of Medicine reported this to be an important public health issue in 2006, and it has continued to be highlighted through the more recent launch of the Cancer Moonshot in the US and the EU beating cancer plan in EU. Though many patients living with advanced breast cancer experience some of the same stressors and long-term impacts of therapies that affect all cancer survivors, they are not routinely included in cancer survivorship programs and research.
The panel will feature speakers with a range of perspectives on breast cancer and, for the first time, will be an international collaboration with our colleagues at the EMA with the hope of highlighting the day-to-day, year-to-year experience of patients living with metastatic breast cancer.
Some of the themes we plan to discuss include:
How people find care for advanced stage breast cancer? What are the barriers to finding new treatments?
What are some of the long-term effects of cancer therapies and how have they impacted patients’ choices for care?
Are there mental health issues that particularly need to be addressed for patients with advanced breast cancer such as stress, difficulty sleeping, job loss?
How can clinical researchers and regulators better address the key issues we have highlighted for patients living with metastatic breast cancer?
Given our new collaboration with the EMA, we also hope to learn from any common threads and/or distinctions amongst patients and providers in U.S. and Europe.
Webcast Information:
A free-of-charge webcast of this public panel discussion will be provided. Registration for the webcast is required at: https://www.surveymonkey.com/r/SGF5FCP
FDA plans to post archived webcast of this Conversations on Cancer program at: https://www.fda.gov/about-fda/project-community/conversations-cancer
Contact:
For any inquiries regarding this program, please send an email to: OCE-Engagement@fda.hhs.gov
Director’s Innovation Speaker Series: Social Connection: An Eye to the Past, Present, and Future
https://www.nimh.nih.gov/news/events/announcements/directors-innovation-speaker-series-social-connection-an-eye-to-the-past-present-and-future
During this lecture, Julianne Holt-Lunstad, Ph.D., will discuss the health impacts of having or lacking social connection. The COVID-19 pandemic raised awareness about loneliness but also revealed gaps in our understanding of the individual and public health impacts of social connection. Dr. Holt-Lunstad will highlight the scope of the issue, evidence of health implications, and challenges and opportunities for translating this evidence into practical solutions and policy.
Date/Time: October 26, 2023, 2:00–3:00 p.m. ET
Location: Virtual or in-person at the NIMH Neuroscience Center buildingv
AHRQ announces new AHRQ Emergency Department Prevention Quality Indicators (ED PQI) Beta v2023 Software
https://qualityindicators.ahrq.gov/software/qi
ED PQI Beta v2023 software (SAS and Windows versions) is available for download from the AHRQ QI website at: https://qualityindicators.ahrq.gov/software/qi.
The ED PQI are area-level measures providing insight into health system performance and population health by measuring the frequency of ED visits for conditions that could be managed outside the hospital by high-quality, community-based care. These indicators capture an important dimension of health care by including care that begins in the ED but does not necessarily result in an inpatient stay. The ED PQI measures intend to identify targets for public health services improvement, to help identify disparities or gaps in care, and to indicate the potential impact of interventions aimed at improved health system functioning.
The ED PQI module includes five area-level Prevention Quality Emergency Department (PQE) Indicators:
PQE 01 - ED Visits for Non-Traumatic Dental Conditions.
PQE 02 - ED Visits for Chronic Ambulatory Care Sensitive Conditions.
PQE 03 - ED Visits for Acute Ambulatory Care Sensitive Conditions.
PQE 04 - ED Visits for Asthma.
PQE 05 - ED Visits for Back Pain.
For software details, please refer to: Release of AHRQ Emergency Department Prevention Quality Indicators Beta Software, v2023 (PDF, 251 KB).
For more information, see Technical Specifications, Software Instructions, Empirical Methods, and frequently asked questions (FAQ), all available on the AHRQ QI website.
Beta Software Feedback:
AHRQ welcomes all feedback from users of the ED PQI Beta v2023 Software. AHRQ is also seeking beta testers to respond to specific questions about the ED PQI Beta v2023 Software beginning in November. Please contact QIsupport@ahrq.hhs.gov for more information or for technical assistance.
Welcome to CDS Connect
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.
https://cds.ahrq.gov/index.php/cdsconnect
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.
miércoles, 27 de septiembre de 2023
During National Hispanic Heritage Month, AHRQ Salutes Promotores de Salud
During National Hispanic Heritage Month, AHRQ Salutes Promotores de Salud: Blog on the contributions of promotors to health and wellness during National Hispanic Heritage Month, the annual celebration of culture, values, impact, and advancements of the Hispanic community in America from Sept. 15 to Oct. 15. The theme of this year’s commemoration is Driving Prosperity, Power, and Progress in America.
Advancing the Impact of Consumer Experience of Care Measurement: What’s Next?
Advancing the Impact of Consumer Experience of Care Measurement: What’s Next?: AHRQ’s National Advisory Council (NAC) asked experts to brief them about the current state of the science of consumer experience measurement with an eye toward what’s next. This blog features are some key takeaways from their discussion at the July 2023 meeting.
Drug Trials Snapshots: CAMZYOS (mavacamten)
Drug Trials Snapshots: CAMZYOS
(mavacamten)
CAMZYOS is a cardiac myosin inhibitor used for the treatment of symptomatic New York Heart Association (NYHA) Class II to III obstructive hypertrophic cardiomyopathy (HCM) in adults to improve functional capacity and symptoms.
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-camzyos
Intergovernmental Negotiating Committee on Plastic Pollution
https://www.unep.org/inc-plastic-pollution?utm_medium=email&utm_source=govdelivery
Global Efforts to Address Plastic Pollution: An FDA Perspective
An arm of the United Nations is working to develop global consensus on how to reduce the rapid increase in plastic pollution. The United Nations Environment Assembly (UNEA), which is the supreme governing body of the United Nations Environment Program, issued Resolution 5/14 on March 2, 2022. It requested that an intergovernmental negotiating committee (INC) be set up to develop an international legally binding instrument on plastic pollution, including in the marine environment, based on a comprehensive approach that addresses the full life cycle of plastic.
The FDA is an active participant in the U.S. government’s interagency efforts related to the negotiation, with the FDA’s Office of Global Policy and Strategy (OGPS) as the agency lead, facilitating expert perspectives from across the agency’s product centers and representing the FDA at interagency and multilateral INC meetings.
Tasked with monitoring this work on a day-to-day basis for OGPS is Matt Scherer, an international policy analyst in the Office of Trade and Global Partnerships. We had a chance to talk about the process with Scherer, and we capture his insights below.
To start out, what precipitated the March 2022 resolution? Could you give us some idea of the problem the resolution is trying to address?
Plastic products have become ubiquitous in our lives – they’re versatile, durable, lightweight, and relatively inexpensive. The global annual production of plastic products has more than doubled over the last 20 years — however, waste management capacity has not kept up. As a result, plastic waste has also doubled. According to OECD [Organisation for Economic Co-operation and Development], 23% of plastic waste was improperly disposed of, burned, or leaked into the environment. Given current trends, it’s predicted that leakage of plastic into the environment will again double by 2060 to 49 million tons per year. This waste finds itself on land, sea, and waterways, and does not know national boundaries, hence the need for a global effort.
What has happened since that March 2022 resolution was adopted?
The resolution provided for the establishment of this intergovernmental negotiating committee, or the INC. So far, there have been two INC meetings, the most recent one was in Paris in May of this year.
These have been opportunities for the parties to the United Nations to get together and start to air their initial views on what the instrument should include. The United States seeks to negotiate an ambitious instrument containing both binding and voluntary provisions that are sufficiently flexible to maximize global participation.
And so, there's been a lot of global dialogue through the INC process, but then in preparation for this dialogue, there's a lot of work happening within the U.S. government to ensure that the appropriate parts of the interagency are engaged and that we develop a position in advance of any more formal, substantive negotiations. That has been a really involved process.
When the average person thinks about ending plastic pollution, putting that empty bottle in a recycle bin is probably all that comes to mind. But the UN has put forth a broad list of 12 possible core obligations that reach deep into all corners of the total life cycle of plastic. Can you expand on this wider view of the plastic pollution problem and how the need for making such critical changes has opened your eyes or been received by governments?
I was part of that “average” group as well, and this project has certainly opened my eyes to the complexities of the problem that covers the entire supply chain for plastic, from production to waste management.
Not only is the INC looking at the downstream measures we’re all familiar with such as improving circularity (reduce, reuse, repair, recycle) and better waste management, but the INC is also considering measures to reduce the production and demand for primary plastic polymers and to control the use of certain substances that have potential adverse health effects or impede circularity of plastic products. There is also a concern about microplastics — very small pieces of plastic that are either intentionally added to some products or that are the result of the degradation of larger pieces of plastic.
There is a desire within the INC to pull all of these levers in the instrument — production, demand, circularity, and waste management — and it will need to be done in a manner that is sensitive to the principles of environmental justice.
Global negotiations are equally complex. There are 193 countries participating in this process — and each has its own experience with plastic pollution and its own relationship with plastic products and producers. You can imagine that a smaller island nation with a tourism-based economy that has plastic debris washing up on its beaches would view the problem differently than an industrial nation whose economy is dependent on the petrochemical industry.
So, it's really quite challenging. We are dealing with a diversity of different perspectives, as well as different governments and legal systems across the world. It's a lot to work through.
What is the FDA’s role in these discussions?
The agency has been engaged in these efforts since the INC was established as there is notable overlap between the commodities FDA regulates and the UNEA resolution. Many FDA-regulated products directly incorporate or are packaged in plastic, which can be integral to their safety and efficacy. There are obvious implications for food contact materials, but plastics are used in medical products, as well. For example, many medical devices include plastic components, and plastic is a frequently used material in pharmaceutical container closure systems, which are important for ensuring product stability and quality. There's also plastic used in many drug and vaccine delivery devices.
The point of all this is that in most, if not all, FDA-regulated commodities, plastic can be important to manage or ensure safety and efficacy. If the UNEA instrument were written in such a way that didn’t account for these important uses of plastic, it could result in unintended consequences such as product shortages. It is important that any agreement focusing on plastic pollution avoid compromising a regulator’s ability to ensure the safety and effectiveness of the products it regulates.
If plastic is so endemic to medical products and food safety, certainly our regulatory counterparts are grappling with some of the same issues?
Yes, I would expect that our regulatory counterparts have been or will be grappling with the same issues. I met with many individuals and organizations at INC-2 in Paris, in both formal and informal settings. Thus far, the delegates I have met were mainly from their countries’ Environmental Ministries, but I am eager to hear how our international health regulatory counterparts are dealing with these same issues. Perhaps there is an opportunity to learn from each other. Working with the FDA’s product centers on this over the last year has given me a keen appreciation for the many nuances of the issue and why regulator participation early in the process is important.
One of the common objectives in many multilateral environmental agreements is to protect human health and this one likely will as well. We embrace that goal and want to ensure it can be achieved without affecting the availability of safe and effective medical products and food.
Is the United States taking into account the views of non-governmental stakeholders?
That is another important part of the process. The State Department (State) is the lead negotiator for the United States. Before each INC, it has been organizing listening sessions with environmental NGOs [nongovernmental organizations] and industry. State also leads engagement with local and state governments, tribes and, of course, the Hill. One task I'm taking on is to ensure that our regulated industry is aware of and engaged in these sessions. I've attended several listening sessions thus far and met directly with stakeholders at INC-2 in Paris and expect to do so again at INC-3 in Nairobi. There is a lot of passion in the NGO community, and they are pushing all members to maximize the ambition of the instrument. Likewise, some aspects of industry are very much engaged as they are likely to be affected by the final provisions of an agreement. Rich stakeholder engagement, including by FDA-regulated entities, is good for the process.
You've attended a couple of meetings already, and you're attending a third meeting in Nairobi, Kenya, in November. So how long can we expect this whole process to take, if you say we're early on?
Well, we're early on in terms of our progress. We're not necessarily early on in the process.
There will be five INC meetings total, and we are coming upon INC-3. The fifth and final INC meeting is planned for late fall 2024 in South Korea. And, at that time, the goal is to have agreed upon text that can then be taken back to each member state’s leadership, to go through their own processes to ratify or sign. So, there is quite a bit of work that has to be done and not a lot of time to do it.
So far, the bulk of the international work has been taking place at these INC meetings, but I think it's clear that starting after INC3, we're going to have intersessional work to achieve the ultimate goal of developing an international instrument to stop plastic pollution.
There is a lot of difficult work ahead, but I am optimistic. There are so many dedicated people across the globe working toward the final objective of ending plastic pollution. I am glad to be one of them.
Annual Report to the Nation Part 2: New cancer diagnoses fell abruptly early in the COVID-19 pandemic
https://www.cancer.gov/news-events/press-releases/2023/annual-report-to-the-nation-part-2-pandemic-cancer-diagnoses?cid=eb_govdel
Annual Report to the Nation: Cancer deaths continue downward trend; modest improvements in survival for pancreatic cancer
https://www.cancer.gov/news-events/press-releases/2022/annual-report-to-the-nation-2022
martes, 26 de septiembre de 2023
How does long covid impact the school experiences of children and young people?
In a recent qualitative study published in BMJ Open, researchers drew evidence from narrative interviews of children and young people (CYP) with Long Covid (LC) to improve their understanding of their school experiences in the United Kingdom (UK).
https://www.news-medical.net/news/20230926/How-does-long-covid-impact-the-school-experiences-of-children-and-young-people.aspx
How the COVID-19 pandemic affected mental well-being of UK secondary school students
In a recent study published in JAMA Network Open, researchers evaluated the impact of coronavirus disease 2019 (COVID-19) on the mental health of secondary school children in the United Kingdom (UK). They also investigated the relationships between individual, home, friendship, and school (e.g., school community, operational elements of the school, the larger school context) variables and secondary school students' mental health challenges and psychiatric well-being before and during the pandemic.
https://www.news-medical.net/news/20230926/How-the-COVID-19-pandemic-affected-mental-well-being-of-UK-secondary-school-students.aspx
Black people are more likely to be physically restrained in emergency rooms, study finds By Anika NayakSept. 25, 2023
https://www.statnews.com/2023/09/25/emergency-departments-restraints-racial-disparities/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275724841&_hsenc=p2ANqtz-_E4BwVBfwfKjew7tIvWC63vtPcTR73X0pvomUL0cWCKBSZDTDbnufwN1Dmj9wdl_ddKXpLNOWuQgaMDpcH8w7g-TDPQQ&utm_content=275724841&utm_source=hs_email
Black patients are more likely to be physically restrained than patients from other racial groups, according to new research out of the University of California, San Francisco, and University of California, Davis. A systematic review that performed a meta-analysis of six studies and looked at over 1.6 million patient encounters showed that restraints were used in ERs in less than 1% of clinical encounters. But Black patients were 31% more likely to be placed in restraints than white patients.
Using physical restraints is meant to be a last result in emergency rooms. The study did not directly address the underlying reasons that Black adults are at greater risk of being physically restrained than other groups, but researchers hypothesize that “structural racism plays an important role,” as one of the study’s authors told STAT’s Anika Nayak.
Dairy farmers are running out of chances to kill the terms ‘oat milk’ and ‘soy milk’ Nicholas Florko By Nicholas Florko Sept. 26, 2023
https://www.statnews.com/2023/09/26/dairy-farmers-oat-milk-soy-milk/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=275724841&_hsenc=p2ANqtz--G2q2ZkXMnuOqTdghOKSpLaUoetaHzsme-932c4AWbeHaPGaSIROb54Hkd9Cjnwpz_LzTLLLBNP-Wvc72nCGkjS63uVw&utm_content=275724841&utm_source=hs_email
The debate over whether nut, oat, and other plant-based alternatives to cow’s milk can be called “the m word” has reached the federal government. In fact, it’s even led one Idaho congressman to go around grocery stores placing “This is not milk” sticky notes on cartons of plant-based drinks.
So far, the Food and Drug Administration has allowed plant-based companies to call their products milk. But the dairy industry has one last shot: adding language to a massive agriculture bill that must pass in the coming months that would ban plant-based companies from using the word milk. The industry has tried this tactic before, and is now splintering on the milk labeling issue.
My STAT colleague Nick Florko dipped into the drama. Read more here.
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing OCTOBER 31, 2023 - NOVEMBER 1, 2023
https://www.fda.gov/drugs/news-events-human-drugs/pharmaceutical-quality-symposium-2023-quality-supply-chain-advanced-manufacturing-10312023?utm_medium=email&utm_source=govdelivery
SBIA | Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing
https://sbiaevents.com/files2023/PQS-2023-Agenda.pdf?utm_medium=email&utm_source=govdelivery
A Family-Centered Approach to Implementing Plans of Safe Care for Infants and Families Affected by Prenatal Substance Exposure Thursday, October 19, 2023 2 - 3 p.m. ET
A Family-Centered Approach to Implementing Plans of Safe Care for Infants and Families Affected by Prenatal Substance Exposure
Thursday, October 19, 2023 2 - 3 p.m. ET
https://cffutures.zoom.us/webinar/register/WN_l7v20c0CQ_ebPD8jBLlbJg?utm_source=SAMHSA&utm_campaign=d73ce9b8f4-EMAIL_CAMPAIGN_2023_09_21_05_03&utm_medium=email&utm_term=0_-d73ce9b8f4-%5BLIST_EMAIL_ID%5D#/registration
The 2016 Amendments to the Child Abuse and Prevention Treatment Act (CAPTA) clarified that for infants affected by prenatal substance exposure, a Plan of Safe Care is developed that addresses “the health and substance use disorder treatment needs of the infants and their affected family or caregiver.” A family-centered approach to plans of safe care assists states, Tribes, and communities in meeting the provisions of this legislation and the needs of families. Join this webinar to learn more about:
The essential elements of a family-centered approach
Michigan’s collaborative systems efforts across home visiting, substance use disorder treatment, healthcare, and child welfare to enhance a family-centered approach to plans of safe care
Data to understand needs and inform progress
Equitable access to family-centered services
Stigma
Meet the Presenters:
Latonya Adjei-Tabi, M.P.A.: Senior Program Associate and serves as Change Liaison for National Center for Substance Abuse and Child Welfare.
Meagan Chuey, Ph.D., CNM, RN: Maternal and Infant Health Nurse Consultant for MDHHS’ Division of Maternal and Infant Health.
Annie Heit, M.P.H., RN: Home Visiting Substance Use Coordinator and lead for the Peer Navigator Pilot Project.
Jessica Kincaid, M.A., LPC: Substance Use Disorder Analyst for the Michigan Children’s Services Administration.
Heather Rosales, LMSW, CAADC: Michigan State’s Women’s Treatment Specialist.
Creative Strategies for Improving Health Access in U.S./Mexico Border Communities Join us for this event in observance of Hispanic Heritage Month!
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