Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week. Ellume last month recalled certain lots of its COVID-19 Home Test due to an increased chance of false-positive results. FDA has classified the recall as a Class I recall, the most serious type.

“The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur,” the agency said.

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...findings support other reports of lead-contaminated turmeric in the United States (1,2) and highlight the diverse pathways through which children can be exposed to lead. They underscore the importance of a multidisciplinary approach and communication between health care providers and health department staff members in identifying potential links among lead poisoning cases, and the need for health care facilities to be prepared to respond to cases of lead poisoning. [CDC 11.12.2021] 

The national blood lead reference level had been 5 μg/dL but was lowered to 3.5 μg/dL in October 2021 (3). There is no safe BLL in children (4); BLLs once thought to pose little to no risk have shown to be risk factors for reading problems, intellectual delays, school failure, attention deficit-hyperactivity disorder, and antisocial behavior (3,5–7). Whereas the impact of lead exposure might be irreversible, exposure is preventable.¶,** Clinicians and public health professionals should be aware of risks outside traditional lead exposures (e.g., paint, dust, and contaminated soil). Adulteration of turmeric has reportedly been a source of lead exposure in other countries (1), where lead is purposefully added to enhance weight and color (2). Referrals for lead-risk assessments should emphasize same-day assessments when possible to reduce continued exposure to and absorption of lead. Public health officials and health care providers should work together to ensure the sources of lead exposure have been identified and controlled before chelation therapy is started. Health care providers who are unfamiliar with chelation therapy should consult with their regional pediatric environmental health specialty unit or poison control center for assistance.

Download PDF of full CDC article here

For full CDC article, click here. 

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This is good news! Few people will delay in taking care of their health. As more people rely on #telemedicine during the pandemic, 2/3 larger employers providing health coverage say they’ve made changes to telemedicine benefits, often affecting where & how people could access virtual care and what services are covered.

Kaiser Family Foundation 11.11.2021

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Perceiving, acknowledging and undoing the many ways medicine has contributed to racial injustice can be a daunting task for health care organizations. And while developing a plan for doing this is a good first step, putting that plan into action in training future physicians can be fraught with false starts and failed objectives.

AMA Equity Plan 2021-2023

Embedding equity into medicine requires planning and honesty. To meet this moment, the AMA has developed a plan to advance racial and social justice.

Read the Strategy

In a plenary presentation, “Operationalizing Racial Justice,” at ChangeMedEd^® 2021, AMA Senior Vice President and Chief Health Equity Officer Aletha Maybank, MD, MPH, provided a survey of the forces in the U.S. that have inhibited a reckoning with racism in medicine. She also outlined the roles of individuals and organizations in improving health equity and the key steps organizations need to take to ensure a successful and thorough transition to a racially just health care system.

ChangeMedEd is the AMA Accelerating Change in Medical Education initiative’s national conference, which brings together innovative leaders from institutions across the medical education continuum to reimagine the way future physicians are trained.

Make honesty your foundation

The AMA this year released a strategic plan to embed racial justice and advance health equity. The plan recognizes the harmful effects of the AMA’s past, targets the systemic inequities in the health care system and other social institutions, and charts a path toward a more promising and equitable future for patients and physicians alike.

The AMA’s plan centers on a three-year road map with five strategic approaches. Dr. Maybank focused on three of them to help other organizations get their health equity aspirations out of the abstract and into action.

Embed racial justice everywhere

One of the AMA’s approaches is to embed racial and social justice throughout its systems, policies, practices and culture. And while those might seem like macro-level issues, they all play out on the level of individuals.

“Most of us have good intentions about the impact of the decisions that we're making,” Dr. Maybank said. “We tend to focus on the parameters definitely around diversity and inclusion—great, important to do. We’ll talk about how are we engaging with communities—[also] important to do.”

But what often isn’t discussed is how to transform ourselves—our minds and hearts—to “work towards changing the structures and the systems that are in place within our institutions that are perpetually harming and driving these inequities,” Dr. Maybank said.

Learn more about health equity education on the AMA Ed Hub™, which features CME from the AMA Center for Health Equity and curated education from collaborating organizations. Resources include AMA STEPS Forward™ open-access toolkits, AMA Journal of Ethics^® articles and podcasts and the “Prioritizing Equity” video series.

Push upstream, and keep pushing

Addressing the determinants of health inequities requires shifting one’s gaze to structural drivers and also empowering physicians and their employers to dismantle structural racism.

Medical education is crucial to this in several ways. One is by adopting a public health framework, which includes supporting the 10 essential public health services.

Another is by eliminating race-based clinical algorithms and teaching about their historical public health implications. Conversations about race-based medicine, Dr. Maybank noted, often center on the impact they have on individual patients. But they may fail to ask about the public health implications that result from so many patients having been prevented from accessing care for so long.

Related Coverage

City-level data reveals health inequities are far from inevitable

Foster racial healing

Charting a new course for a health system and a community requires promoting pathways for truth, reconciliation and transformation.

The AMA, for its part, recently removed the bust of Nathan Smith Davis, MD—commonly thought of as the association’s founder—from public view and placed it in the organization’s archive. Dr. Davis actively worked to exclude Black and women physicians from membership in the AMA in the mid- to late-19th century.

“These are not easy decisions, but again, I think if we're really committed to this space of equity—not harming [but] valuing, caring for people … we have the opportunity to do better and differently,” Dr. Maybank said.

Watch a recent “Prioritizing Equity” panel discussion with leaders from the AMA, American Academy of Pediatrics and the American Psychiatric Association on moving beyond apology toward restorative justice.

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An AHRQ-funded resource–"Six Building Blocks: A Team-Based Approach to Improving Opioid Management in Primary Care How-To-Implement Toolkit"—is available to help primary care teams reduce the number of patients on long-term opioid therapy for chronic pain. The evidence-based toolkit offers a quality improvement roadmap for redesigning patient care without practice facilitators or other external support. It helps clinical staff develop standardized workflows, track key measures and use electronic health record tools and registries. ###

A federal appeals court in New Orleans has suspended a COVID-19 vaccination requirement announced by President Joe Biden's administration for private employers with more than 100 employees, according to The Washington Post. [Becker's Health Review 11.7.2021) 

What is ahead for Illinois and other states? 

The U.S. Court of Appeals for the Fifth Circuit issued the decision Nov. 6 after a group of plaintiffs — including Louisiana, Utah, Texas, South Carolina and Mississippi — filed a lawsuit Nov. 5 questioning the Occupational Safety and Health Administration's authority in issuing the rule. 

In the decision, a panel of three judges wrote there is "cause to believe there are grave statutory and constitutional issues with the mandate."

The court's decision — which is not a ruling on policy merits — temporarily stops the vaccination requirement while the court does a more thorough review. The Justice Department has until 5 p.m. Nov. 8 to respond to the lawsuit's request for a more permanent freeze of the requirement.

Louisiana Attorney General Jeff Landry issued a statement praising the Fifth Circuit's decision, describing it as "a win for the liberty of job creators and their employees." He said the court's action "not only halts Biden from moving forward" but also "commands the judicious review we sought." 

OSHA issued an emergency temporary standard Nov. 4 outlining COVID-19 vaccination requirements for employers with 100 or more employees. The standard is expected to cover 84 million private-sector workers and two-thirds of the U.S. private-sector workforce. 

OSHA said businesses covered by the emergency temporary standard must put in place a mandatory COVID-19 vaccination policy, unless they adopt a policy requiring employees to be vaccinated or undergo regular testing and wear a face covering at work. Under the standard, employers also must provide paid time off to workers to get inoculated and provide paid leave to employees to recover from any side effects.

In an interview Nov. 7 on ABC , U.S. Surgeon General Vivek Murthy, MD, defended the vaccination requirement.

"The President and the administration wouldn't have put these requirements in place if they didn't think that they were appropriate and necessary, and the administration is certainly prepared to defend them," he told "This Week" co-anchor Martha Raddatz, adding that there is a history of vaccination requirements in the U.S.

But the emergency temporary standard has received some pushback from states and business groups, which are concerned about disruptions during the holiday season.

In addition to the Fifth Circuit case in Louisiana, a coalition of 11 states sued President Biden's administration Nov. 5 in the U.S. Court of Appeals for the Eighth Circuit over the rule for private businesses.

CMS has also announced a separate vaccination rule expected to cover 17 million healthcare workers at healthcare facilities participating in Medicare and Medicaid programs. The CMS regulation preempts state laws and other federal regulation requirements for all facilities that are regulated by CMS' Conditions of Participation.

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Chicago’s top doctor said Thursday the city continues to see a slight uptick in its COVID-19 metrics. [Health News Illinois  11.5.2021]

The seven-day average for new daily cases in Chicago is 328, a 12 percent increase from the prior week. The seven-day test positivity rate is 1.8 percent, a 0.2 percentage point increase from the prior week.

Chicago is also averaging 19 COVID-related hospitalizations per day, up two from the prior week.

“If we take a look, we still are seeing a little bit of an uptick in our numbers,” Chicago Department of Public Health Commissioner Dr. Allison Arwady said during a Facebook live event. While all metrics outside of daily deaths are increasing, she stated that none are yet in a high-risk category for transmission. 

Arwady also said the city continues to make progress on its goal to have at least 77 percent of eligible residents receive at least one dose of vaccine by the end of the year. 

About 75.5 percent of eligible Chicago residents have received at least one dose of a COVID-19 vaccine as of Thursday, while 69.6 percent are fully vaccinated.

Data on kids ages 5 to 11 will be on the website by next week, Arwady said.

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State and Chicago-area health officials said Wednesday they will adopt federal recommendations for Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11 years old, with initial shipments of doses already being received by providers. [Health News Illinois 11.4.2021]

The Centers for Disease Control and Prevention on Tuesday authorized the vaccine for use in the age group, with a smaller dose to be administered three weeks apart.

Chicago Department of Public Health Commissioner Dr. Allison Arwady said they have already received 30,000 doses.

“This is great news for our children and our families, and a decision that I know parents have been waiting for,” she said. “We have been planning our roll out for weeks ... and vaccinations can begin right away.”

The Illinois Department of Public Health previously said it expects to receive an initial shipment of 500,000 doses, with nearly 306,000 of the initial doses going to the state, 73,000 to the city of Chicago and over 100,000 to the federal government’s pharmacy partners.

Approximately 2,200 pediatric providers in Illinois have enrolled in the state’s immunization registry and can administer the COVID-19 vaccine to their patients, the agency said in a statement. Work also continues with schools to set up vaccination clinics and more than 1,200 youth vaccination events have been held or are scheduled.

“We need as many people as possible, including children, to be vaccinated to stop the spread of the virus and end this pandemic,’ said IDPH Director Dr. Ngozi Ezike.

Chicago’s in-home vaccination program will begin offering pediatric vaccination for all eligible children starting Nov. 15.

The Illinois Department of Public Health reported 1,746 new COVID-19 cases and 41 deaths on Wednesday.

The new cases bring the state’s total to 1,705,777, while the death toll is 25,898.

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Importance: Rural hospitals are increasingly merging with other hospitals. The associations of hospital mergers with quality of care need further investigation.

Objectives: To examine changes in quality of care for patients at rural hospitals that merged compared with those that remained independent.

Design, setting, and participants: In this case-control study, mergers at community nonrehabilitation hospitals in Federal Office of Rural Health Policy-eligible zip codes during 2009 to 2016 in 32 states were identified from Irving Levin Associates and the American Hospital Association Annual Survey. Outcomes for inpatient stays for select conditions and elective procedures were derived from the Healthcare Cost and Utilization Project State Inpatient Databases. Difference-in-differences linear probability models were used to assess premerger to postmerger changes in outcomes for patients discharged from merged vs comparison hospitals that remained independent. Data were analyzed from February to December 2020. 

... Conclusions and relevance: These findings suggest that rural hospital mergers were associated with better mortality outcomes for AMI and several other conditions. This finding is important to enhancing rural health care and reducing urban-rural disparities in quality of care.

See full article here>

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Children ages 5-11 should be vaccinated against COVID-19 with the Pfizer/BioNTech vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) said on Tuesday. [MedPage 11.2.2201]

ACIP voted 14-0 to recommend vaccinating this population with a two-dose regimen of 10 μg apiece, 21 days apart, citing the favorable benefit-risk association, the idea of restoring normalcy to children, and especially the extensive data presented by FDA and CDC staff.

"Today is a monumental day in the course of this pandemic and one that many of us will be very eager to see," said CDC Director Rochelle Walensky, MD, once again addressing the panel. She added that since the first vaccines were authorized for ages 16 and up, the question has been when protection might be expanded to younger children. 

This is a "recommendation likely to have tremendous impact," Walensky said. She said she was eager to see how committee members "interpret what we know and acknowledge areas of uncertainty."

Walensky also said that 745 children have died of COVID during the pandemic, including 94 children ages 5-11, and over 2,300 children in this population have been diagnosed with multi-system inflammatory syndrome (MIS-C).

Many committee members spoke as parents and grandparents and explained how they have vaccinated their children and grandchildren. Consumer representative Veronica McNally, JD, got a bit choked up when talking about how she would vaccinate her child after this recommendation, and would do so to prevent "the 95th death" in a child.

In an unusual move, several liaison representatives from the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), National Association of Pediatric Nurse Practitioners (NAPNAP), and the Pediatric Infectious Diseases Society (PIDS) read statements in support of vaccination for this age group prior to the ACIP vote.

Full article here> 

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