Here’s how the FDA is advising hospitals to prepare for future public-health emergencies

While the COVID-19 pandemic is far from over — and not even close to slowing down — the Food and Drug Administration is already looking toward the next public health emergency.

The FDA has released a list of essential medications that hospitals should stock up on in the event of a public-health emergency. (Getty Images)
The FDA has released a list of essential medications that hospitals should stock up on in the event of a public-health emergency. (Getty Images)

On Friday, the FDA released a list of essential medications and “medical countermeasures” — which include drugs and devices for “a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease” — that are needed to help combat future threats to public health.

The list, which contains 223 drug and biological product essential medicines and medical countermeasures, along with 96 medical devices, features items that the FDA has deemed “medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms,” according to a press release issued by the agency.

“Basically, it’s a list of meds and devices to cover many conditions so that hospitals will be fully prepared in the event that there are mass shortages,” Jamie Alan, an assistant professor of pharmacology and toxicology at Michigan State University, explains to Yahoo Life. “This would be something the pharmacy could cross-check to make sure they were stocked up on everything they need.”

The list was created on the prompting of an executive order issued in early August.

“The goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological and nuclear threats,” the release says. “To accomplish this goal, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products.”

Ventilators were among the nearly 100 essential medical devices included on the FDA's list, which largely covered medications. (Getty Images)
Ventilators were among the nearly 100 essential medical devices included on the FDA’s list, which largely covered medications. (Getty Images)

The medications identified are ones that are “most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions,” the release says. The devices include diagnostic testing kits, supplies for rapid test development and processing, personal protective equipment, active vital-sign monitoring devices, devices for vaccine delivery and medical devices like ventilators.

According to the FDA, the items that made the list are what the agency anticipates “will be needed to respond to future pandemics, epidemics, and chemical, biological and radiological/nuclear threats.”

“When identifying essential medicines and medical countermeasures, we focused on including those that are medically necessary to have available in adequate supply which can be used for the widest populations to have the greatest potential impact on public health,” the release says.

The list will be used by federal partners to “carry out directives in the executive order, such as facilitating domestic production and increasing the domestic procurement of items on the

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NYC hospitals prepare for virus resurgence

NEW YORK (AP) — Like battle-hardened veterans, New York City hospitals and nursing homes are bracing for a potential resurgence of coronavirus patients, drawing on lessons learned in the spring when the outbreak brought the nation’s largest city to its knees.

The new playbook derives from the apocalyptic days of March and April, when testing and resources were scarce, emergency rooms overflowed, and funeral homes stacked corpses in refrigerated trailers.

Those insights, however hard won, make it far less likely that the city’s hospitals would collapse under a second wave of COVID-19, health care leaders said.


Even without a vaccine, doctors are touting increasingly effective coronavirus treatments, three-month supplies of personal protective equipment and contingency staffing plans.

Similar preparations are underway at New York’s hard hit nursing homes, which accounted for a staggering percentage of the state’s coronavirus deaths.

“We didn’t even have testing in February when there was so much transmission,” Dr. Mitchell Katz, head of the city’s public hospital system, said in an interview. “I can’t see how we’d ever have the same situation that we had in March and April, but we are preparing for that possibility anyway.”

Not only has critical care improved, Katz said, but coronavirus patients also are generally “not getting as intense as an exposure as they once did because of the wearing of masks.” New cases also are afflicting younger people, who are less likely than older patients to need hospitalization.

“Our hospitals are still quieter than they would have been a year ago because people are avoiding care out of concerns about COVID,” Katz added. “We can have several hundred additional patients and still not be full.”

New York has recorded nearly 37,000 new COVID-19 infections in October and is on pace to have more than double the number of people sickened this month as fell ill in September.

But so far, that increase has led to only a modest uptick in hospitalizations. On average, about 45 people a day have been admitted to New York City hospitals each day in October, city statistics show, up from an average of 29 per day in September.

That compares to an average 1,600 per day during the worst two weeks of the pandemic in March and April — a time when the state also recorded its highest daily death tolls and ambulance sirens became an ominous soundtrack to the city’s out-of-control pandemic.

Last week, by contrast, the city’s 11 public hospitals had six total intubated patients — down from a peak of 960.

The relative quiet stands in stark contrast to hospitals in Europe and the Mountain West that have been increasingly overwhelmed by new surges.

“The measures that were put in place seem to be working,” said Dr. Fritz Francois, chief medical officer at NYU Langone Health, alluding to widespread mask use, social distancing and authorities’ focus on hot spots in pockets of the city.

“Even if we see something of a resurgence,” Francois said, “the outlook is that it’s not going

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Nursing homes prepare for third COVID-19 surge

 Nursing homes, long in the spotlight as a key battleground in the fight to prevent the spread of COVID-19, are making key structural changes to prepare for an expected third surge of the disease. 

Facilities have implemented increased testing, promoted mask use and changed clinical practices in an effort to protect older Americans who are at higher risk of complications from the coronavirus.

While many changes are temporary to mitigate the virus until a vaccine is available, others are more permanent.

I think that what wont end will be a renewed and strengthened emphasis on infection control,” said Mark Parkinson, CEO of the American Health Care Association and National Center for Assisted Living (AHCA/NCAL).

The AHCA/NCAL, which represents more than 14,000 skilled nursing centers, assisted living communities and other homes, is preparing for “the next pandemic,” Parkinson said, as many weren’t prepared for the current one.

We are on hyper, high alert every single day and we will be until there is a vaccine and everyone gets vaccines,” Parkinson said.

More than 60,400 nursing home residents have died from COVID-19, with more than 260,500 confirmed cases across the country, according to the Centers for Medicare & Medicaid Services (CMS).

Health care experts say that despite the high figures, the situation has improved from earlier this year, when the coronavirus was spreading like wildfire in nursing homes across the country.

Parkinson said the situation at nursing homes was horrific” in March and April, with nearly 7,000 people dying of COVID-19 a month and a half into the pandemic.

The largest number of deaths have been in New York, California, New Jersey, Texas, Massachusetts, Florida and Illinois, with those seven states accounting for over 45 percent of all nursing home fatalities.

The states with the highest number of deaths per 1,000 residents include Massachusetts, New Jersey, Connecticut, Louisiana, Rhode Island, Mississippi, Georgia and Pennsylvania.

Conditions in nursing homes have improved dramatically since March. The two biggest reasons are the availability of personal protective equipment [PPE] back in March and April — we just didnt have the PPE that we needed to keep the virus from spreading — and the second thing thats occurred is the availability of testing,” Parkinson said.

Alex Brill, resident fellow at the American Enterprise Institute, noted that while the situation at nursing homes is improving, an increase in cases in parts of the U.S. will impact facilities for older Americans.

The nursing home COVID crisis in New York and New Jersey and Connecticut from the beginning of the pandemic, things are different and way better there. But as the pandemic is spreading throughout the country, we’re going to see it pop up in other nursing homes,” Brill said.

He added, If there’s a nursing home that hasn’t had many or any COVID-related deaths yet, they have to continue to watch what’s happening in their local community and be prepared for outbreaks.”

The first

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DVIDS – News – Task Force Illini Soldiers prepare for the new Army fitness test


LVIV, Ukraine – On Oct. 1, the implementation stage of the Army Combat Fitness Test (ACFT) began as the Army replaces the Army Physical Fitness Test (APFT) to assess Soldier fitness. Task Force Illini Soldiers are preparing for the new standards while deployed.

Prior to October 2020, Soldiers were required to take the 3-event APFT. The APFT included two-minutes of push-ups and sit-ups, and a 2-mile run. Participants were scored on the number of repetitions they completed against standards for their age and gender. Soldiers will not be required to take the ACFT for a record score until 2022.

The ACFT, now in its implementation stage, is the Army’s new 6-event test including a three-repetition maximum deadlift, a standing power throw, hand release push-ups, a sprint-drag-carry, leg tucks, and a two-mile run. The Army determined these events will better serve to gauge a Soldier’s physical readiness to complete basic Soldier tasks and perform to the classification of their Military Occupational Specialty (MOS) regardless of age and gender.

The scoring classifications for the ACFT are, in ascending score order: “moderate,” which includes occupations such as Wheeled Vehicle Mechanic and Unit Supply Specialist; “significant,” for occupations like Health Care Specialist and Human Resource Specialist; and “heavy” for occupations such as Cavalry Scout and Motor Transport Operator.

“I think it’s a good comprehensive assessment of someone’s fitness. I think it is going to be a challenge for unit leaders to implement. It will be a rough start, but I am optimistic that we’ll get past the learning curve,” said Capt. Jonathon Gosa, a Task Force Illini Brigade Fires Advisor from East Moline, Illinois.

Though Task Force Illini Soldiers are not currently required to take the ACFT during their deployment, but many members are still using their time to prepare themselves for the test.

“I’m getting in better shape for the new ACFT. As a junior non-commissioned officer, I can’t expect my Soldiers to do anything I can’t do myself,” said Cpl. Cody Gaboriault, an Artillery Repairer from Creve Couer, Illinois.

Soldiers said they are looking forward to challenging themselves to complete the new ACFT events, and they have noted what they need to work most on.

“The sprint-drag-carry seems like the most endurance heavy event. It will be a test of mental and physical strength,” said Sgt. Dayna Brown, an Automated Logistics Specialist from Decatur, Illinois.

The deadlift seems to be the event most Task Force Illini Soldiers are looking forward to. The event requires a Soldier to deadlift between 140 and 340 pounds depending on their physical requirement classification.

“I’m excited for deadlifting because it’s already a part of my workout routine,” said Spc. Gianna Polizzi, Supply Specialist and Chicago resident. “I think the ACFT will be beneficial for those who already love strength training and for those who want to get into it more.”

Task Force Illini is the command element of Joint Multinational Training Group-Ukraine, which is responsible

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States prepare for their own vaccine safety reviews amid worries about Trump’s influence on the FDA

“Frankly, I’m not going to trust the federal government’s opinion,” New York Gov. Andrew Cuomo said in announcing his state’s vaccine review panel. California Gov. Gavin Newsom, who announced his state’s 11 member panel of doctors and scientists on Monday said: “Of course we won’t take anyone’s word for it.”

President Donald Trump’s intense push for a vaccine before the election – which is now virtually impossible given that none of the leading vaccine candidates will be ready by then — on top of administration pressure on the FDA and Centers for Disease Control, have sowed growing public doubt about vaccine safety, particularly as the research into the shots has progressed at an unprecedented breakneck pace.

A CNN poll from earlier this month showed only about half of Americans might get a vaccine, while a more recent Stat News poll revealed 58 percent of the U.S. public said they would get vaccinated as soon as a vaccine was available – a big decline over its prior poll. If large numbers of people spurn the shot, its power to beat back the pandemic is diminished.

States have not yet released a lot of details about their vaccine reviews. The additional layer of oversight raises questions about whether a state agency could impede use of a federally-approved vaccine, and whether they could end up slowing down the pandemic response, rather than enhancing it.

Even though governors say they are protecting their residents in case pressure from the White House leads the FDA to approve a flawed vaccine, some officials and public health advocates are warning that these state interventions could confuse the public and prevent people from seeking a shot even if it is safe and effective.

It is “hard to see how any state could replicate anything like the national, gold standard system” of FDA approval, said former FDA commissioner Mark McClellan, who now heads a major health policy center at Duke.

Critics of the state review panels include both Republicans in Congress as well as nonpartisan public health experts in both the advocacy and academic worlds.

Rep. Greg Walden of Oregon, the outgoing top Republican on the House Energy and Commerce Committee, which oversees the FDA, called the state vaccine panels a “reckless” idea that would “dangerously undermine the FDA” and increase public vaccine hesitancy.

Walden told a recent committee hearing that the FDA had ample safeguards, including an independent data safety monitoring board for each vaccine trial, as well as the outside experts that serve on the FDA’s Vaccines and Related Biological Products Advisory Committee. FDA Commissioner Stephen Hahn has said the advisory panel, which meets for the first time to discuss Covid-19 vaccines this Thursday, will review every vaccine prior to an emergency authorization or approval.

States “would be hard-pressed to find more qualified experts” than those already on the FDA and CDC advisory panels, said Amy Pisani, executive director of the nonprofit Vaccinate Your Family. Their “recommendations will speak for themselves,” she said.

Traditionally the states have

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