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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EU will fund transfer of Covid-19 patients across borders to prevent hospitals buckling

The European Union has earmarked 220 million euros ($257 million) to fund the transfer of Covid-19 patients across its borders to prevent the hospital systems in the 27-nation bloc from buckling.



a person standing in a room: Healthcare workers wearing personal protective equipment (PPE) care for Covid-19 patients in an intensive care unit (ICU) at Thomayer hospital on October 14, 2020 in Prague. - The Czech Republic has the European Union's highest rate of coronavirus infection, according to the European Centre for Disease Prevention and Control. (Photo by Michal Cizek / AFP) (Photo by MICHAL CIZEK/AFP via Getty Images)


© MICHAL CIZEK/AFP/AFP via Getty Images
Healthcare workers wearing personal protective equipment (PPE) care for Covid-19 patients in an intensive care unit (ICU) at Thomayer hospital on October 14, 2020 in Prague. – The Czech Republic has the European Union’s highest rate of coronavirus infection, according to the European Centre for Disease Prevention and Control. (Photo by Michal Cizek / AFP) (Photo by MICHAL CIZEK/AFP via Getty Images)

Europe has become the world’s epicenter of the virus for the second time since the pandemic began, forcing several countries to reimpose national lockdowns as a second wave envelops the region and infections surpass 10 million.

Health officials in several EU countries have warned that their hospitals are near capacity and have raised the alarm that more cooperation is needed to ensure facilities are not overwhelmed.

“Numbers of cases are rising, numbers of hospitalizations are rising, numbers of deaths are rising — not as fast, fortunately, because we understand better today how to treat COVID patients and how to deal with disease,” EU Commission chief Ursula von der Leyen said Thursday night.

“But the spread of the virus will overwhelm our healthcare systems if we do not act urgently.”

Von der Leyen made her comments at a meeting with EU leaders, in which she laid out a number of measures to streamline and centralize the bloc’s Covid-19 response, from the use of tests, tracing apps and the distribution of vaccines.

The EU chief said the bloc was intensifying its efforts in obtaining and validating a vaccine, and that its members had agreed to a “fair distribution” to each state.

“The member states will all get vaccines at the same time and at the same conditions, based on their share of the EU population they have,” she said.

The EU will also now carry out rolling reviews from pharmaceutical companies, who will share quicker “step-by-step” updates with the bloc as they carry out their trials.

In terms of testing, the bloc is working to validate rapid antigen tests that can provide quicker results than the PCR (polymerase chain reaction) tests currently in use. In addition, the EU aims to mutually recognize test results across the bloc.

It will also try to share data collected through tracing apps. Twenty-two of the 27 member states have developed or are in the process of developing an app, and three have connected to a new European gateway since Monday. The 19 others hope plan to join in November.

Von der Leyen said there had been around 50 million app downloads in the bloc, but that was “not enough.”

“We need across the board coverage in the European Union,” she said.

The EU’s effort to centralize its response comes after it was criticized for poor coordination at the beginning of the region’s outbreak. Hard-hit countries like

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Wealthier hospitals stockpiling N95 masks leave nursing homes scrambling

Nursing homes, small physician offices and rural clinics are being left behind in the rush for N95 masks and other protective gear, exposing some of the country’s most vulnerable populations and their caregivers to COVID-19 while larger, wealthier health care facilities build equipment stockpiles.

Take Rhonda Bergeron, who owns three health clinics in rural southern Louisiana. She said she’s been desperate for personal protective equipment since her clinics became COVID testing sites. Her plight didn’t impress national suppliers puzzled by her lack of buying history when she asked for 500 gowns. And one supply company allows her only one box of 200 gloves per 30 days for her three clinics. Right now, she doesn’t have any large gloves on-site.

“So in the midst of the whole world shutting down, you can’t get PPE to cover your own employees,” she said. “They’re refilling stuff to larger corporations when realistically we are truly the front line here.”

More than eight months into the pandemic, health care leaders are again calling for a coordinated national strategy to distribute personal protective equipment to protect health care workers and their patients as a new wave of disease wells up across most of the country. The demand for such gear, especially in hot spots, can be more than 10 times the pre-pandemic levels. While supply chains have adjusted, and the availability of PPE has improved dramatically since the mayhem of the spring, limited factories and quantities of raw materials still constrain supply amid the ongoing high demand.

In this free-market scramble, larger hospitals and other providers are stockpiling what they can even while others struggle. Some facilities are scooping up supplies to prepare for a feared wave of COVID-19 hospitalizations; others are following new stockpiling laws and orders in states such as California, New York and Connecticut.

“They’re putting additional strain on what’s still a fragile hospital supply chain,” said Soumi Saha, vice president of advocacy for Premier Inc., a group-purchasing organization that procures supplies for over 4,000 U.S. hospitals and health systems of various sizes. “We want available product to go to front-line health care workers and not go into a warehouse right now.”

Related: A second surge of the coronavirus in the fall and winter could be catastrophic for the U.S. It’s not just more sick people that doctors worry about.

Over a quarter of nursing homes in the country reported a shortage of items such as N95 masks, gloves or gowns from Aug. 24 through Sept. 20. A recent survey from the American Medical Association found 36 percent of physician offices reported having a difficult time securing PPE. And about 90 percent of nonprofit Get Us PPE’s recent requests for help with protective gear have come from non-hospital facilities, such as nursing homes, group homes and homeless shelters.

“I can completely understand that large health systems don’t want to find themselves short on PPE,” said Dr. Ali Raja, co-founder of Get Us PPE and executive vice chairman of emergency medicine at

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EU to fund transfer of COVID-19 patients across borders to prevent hospitals collapse

BRUSSELS (Reuters) – The European Union will finance the transfer of patients across borders within the bloc to prevent hospitals from getting overwhelmed as COVID-19 infections and hospitalizations spike in the continent.

European Commission President Ursula Von Der Leyen gives a news briefing at the end of a virtual conference with EU leaders about EU government’s measures against the coronavirus disease (COVID19) crisis, in Brussels, Belgium, October 29, 2020. Olivier Hoslet/Pool via REUTERS

After a video conference of EU leaders to discuss the health crisis on Thursday, the head of the EU Commission Ursula von der Leyen said the EU executive had made available 220 million euros ($260 million) to move COVID-19 patients across borders.

“The spread of the virus will overwhelm our healthcare systems if we do not act urgently,” she said.

At the meeting leaders agreed to better coordinate efforts to battle the virus as infections in Europe exceeded 10 million, making the continent again the epicenter of the pandemic.

EU countries want to avoid divisions which dogged the 27-nation bloc at the beginning of the pandemic, when nations vied with each other to buy scarce medical equipment.

To better trace infections, von der Leyen said the EU would work for the quick validation at EU level of rapid antigen tests, which allow quicker results than the standard PCR (polymerase chain reaction) molecular kits.

The Commission is also intensifying its efforts to get potential vaccines against the new coronavirus.

The EU was in talks with four companies, and had already sealed supply deals with another three, she said.

The EU has secured potential vaccines being developed by AstraZeneca, Sanofi and Johnson & Johnson.

It has also said it is in talks with Moderna, CureVac and a partnership of Pfizer and BionTech. Reuters reported in September that the EU was also in preliminary talks with Novavax.

The chair of the meeting, Charles Michel, said EU leaders committed to a fair distribution of vaccines once available. That would be done in proportion to population, von der Leyen said.

Michel said vaccination plans at a national level were crucial to make sure the first limited doses of vaccines could be distributed quickly to those most in need.

Many countries however have not yet defined their inoculation plans, and have different targets.

($1 = 0.8461 euros)

Reporting by Francesco Guarascio, Robin Emmott, Jan Strupczewski; editing by Richard Pullin

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Utah hospitals ‘can’t keep up’ amid record-breaking surge

SALT LAKE CITY (AP) — Utah Gov. Gary Herbert and health officials said Thursday the state may soon need to implement crisis care protocols as hospitals reach a breaking point amid a record coronavirus surge.

Understaffing and a shortage of ICU beds could soon force Utah hospitals to shift to the protocols that dictate how patients will be treated when the system is overloaded.

Utah residents must take public health guidelines and mask-wearing seriously to avoid the drastic measures, health officials said.

“We cannot continue to argue about masking,” said Dr. Mark Shah, an emergency physician with Intermountain Healthcare. “We cannot continue to argue about whether this pandemic is real or made up. And we cannot continue to argue that health care will continue to be fine.”

In the past week, Utah’s positivity average has increased from 15.5% to 18.1%, according to state data. The weekly average for new cases per day has increased from 1,578 to 1,837. State epidemiologist Dr. Angela Dunn said that such a high positivity rate indicates the numbers of infection are far higher.


“The hospitals frankly just can’t keep up with the trend that we have going now as more and more people are going to be demanding hospital care,” Herbert told reporters.

Two more counties were placed in the high transmission category on Thursday, bringing the total with mask requirements to 23. Herbert, who has pushed for voluntary mask usage, said enforcement of health order requirements in the areas would be up to local officials.

There have been over 110,000 reported virus cases in Utah and 598 people have died, according to state data.

For most people, the new coronavirus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.

___

Sophia Eppolito is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

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FBI, DHS Warn Hospitals of ‘Credible Threat’ from Hackers

Several federal agencies on Wednesday warned hospitals and cyber-researchers about “credible” information “of an increased and imminent cybercrime threat to U.S. hospitals and health-care providers.”

The FBI, the Department of Health and Human Services and the Cybersecurity and Infrastructure Security Agency, part of the Department of Homeland Security and known as CISA, said hackers were targeting the sector, “often leading to ransomware attacks, data theft and the disruption of health-care services,” according to an advisory.

The advisory warned that hackers might use Ryuk ransomware “for financial gain.”

The warning comes as COVID-19 cases and hospitalizations surge across the country. The cybersecurity company FireEye Inc. said multiple U.S hospitals had been hit by a “coordinated” ransomware attack, with at least three publicly confirming being struck this week.

Ransomware is a type of computer virus that locks up computers until a ransom is paid for a decryption key.

The attack was carried out by a financially motivated cybercrime group dubbed UNC1878 by computer security researchers, according to Charles Carmakal, FireEye’s strategic services chief technology officer. At least three hospitals were severely affected by ransomware on Tuesday, he said, and multiple hospitals have been hit over the past several weeks. UNC1878 intends to target and deploy ransomware to hundreds of other hospitals, Carmakal said.

“We are experiencing the most significant cybersecurity threat we’ve ever seen in the United States,” he said. “UNC1878, an Eastern European financially motivated threat actor, is deliberately targeting and disrupting U.S. hospitals, forcing them to divert patients to other health-care providers.”

Multiple hospitals have already been significantly affected by Ryuk ransomware and their networks have been taken offline, Carmakal added. “UNC1878 is one of most brazen, heartless, and disruptive threat actors I’ve observed over my career.”

Attackers using Trickbot malware, which is also cited in the federal advisory, claimed Monday in private communications channel to have attacked more than 400 hospitals in the U.S., said Alex Holden, the founder of the cyber investigations firm Hold Security. By Tuesday, the Trickbot attack group — which frequently works with ransomware operators Ryuk — claimed to have ransomed about 30 medical facilities around the country, Holden said.

Noncriminals running these malware and ransomware operations are known to embellish their achievements, he said.

St. Lawrence Health System in New York, Sonoma Valley Hospital in California, and Sky Lakes Medical Center in Oregon on Tuesday all publicly stated they were affected by ransomware attacks, according to local news reports.

The ransomware that has targeted hospitals, retirement communities and medical centers this year has typically started with emails that purport to be corporate communications and sometimes contain the name of the victim or their company in the text or its subject line, according to a FireEye report released Wednesday. However, the emails can contain malicious Google Docs, typically in the form of a PDF file, that contains a link to malware. The use of multiple links, as well as PDF files, can help trick email filters designed to spot simpler phishing tactics.

—With assistance

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US Authorities Warn Of ‘Imminent’ Cyber Threat To Hospitals

US security authorities warned Wednesday of an “imminent cybercrime threat” to hospitals and healthcare providers, urging them to increase their protection.

An advisory released by the FBI and two other government agencies said they had “credible information” that hackers were targeting the healthcare sector using malware, “often leading to ransomware attacks, data theft, and the disruption of healthcare services.”

The threat comes as US hospitals grapple with rising numbers of coronavirus cases, during a pandemic which has so far killed more than 226,000 people in the country.

Ransomware is a type of malicious software used by cybercriminals to encrypt users’ files until a ransom is paid.

Healthcare institutions have been frequent victims of ransomware for several years in the US and globally.

US federal agencies warned hackers were targeting the healthcare sector using malware that can lead to ransomware attacks US federal agencies warned hackers were targeting the healthcare sector using malware that can lead to ransomware attacks Photo: AFP / NICOLAS ASFOURI

Last month, a suspected ransomware attack disrupted patient care at a large chain of hospitals and clinics operating in the United States and Britain.

In 2017, the UK’s national healthcare system was one of the victims in a wave of global ransomware attacks, prompting some of its hospitals to divert ambulances and scrap operations.

The federal agencies urged US healthcare providers to take “timely and reasonable precautions” to protect their networks.

They encouraged healthcare providers to patch their operating systems, software and firmware as soon as possible, and to conduct antivirus and anti-malware scans regularly.

The agencies also recommended changing passwords regularly and using multi-factor authentication.

Copyright AFP. All rights reserved.

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FBI: U.S. Hospitals Targeted in Ransomware Attacks

(BOSTON) — Federal agencies warned that cybercriminals are unleashing a major ransomware assault against the U.S. healthcare system. Independent security experts say it has already hobbled at least five U.S. hospitals this week, and could potentially impact hundreds more.

In a joint alert Wednesday, the FBI and two federal agencies warned that they had “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” They said “malicious cyber actors” are targeting the sector with ransomware that could lead to “data theft and disruption of healthcare services.”

The aggressive offensive by a Russian-speaking criminal gang coincides with the U.S. presidential election, though there was no immediate indication it was motivated by anything but profit.

“We are experiencing the most significant cyber security threat we’ve ever seen in the United States,” Charles Carmakal, chief technical officer of the cybersecurity firm Mandiant, said in a statement. He’s concerned that the group may deploy malware to hundreds of hospitals over the next few weeks.

Alex Holden, CEO of Hold Security, which has been closely tracking the ransomware in question for more than a year, agreed that the unfolding offensive is unprecedented in magnitude for the U.S. Administrative problems caused by ransomware, which scrambles data into gibberish that can only be unlocked with software keys provided once targets pay up, could further stress hospitals burdened by a nationwide spike in COVID-19 cases.

The cybercriminals suspected of the attacks use a strain of ransomware known as Ryuk, which is seeded through a network of zombie computers called Trickbot that Microsoft began trying to counter earlier in October. While the company has had considerable success knocking Trickbot command-and-control servers offline through legal action, analysts say criminals have still been finding ways to spread Ryuk.

The U.S. has seen a plague of ransomware over the past 18 months or so.

In September, a ransomware attack hobbled all 250 U.S. facilities of the hospital chain Universal Health Services, forcing doctors and nurses to rely on paper and pencil for record-keeping and slowing lab work. Employees described chaotic conditions impeding patient care. Also in September, the first known fatality related to ransomware occurred in Duesseldorf, Germany, when an IT system failure forced a critically ill patient to be routed to a hospital in another city.

Holden said he alerted federal law enforcement Friday after monitoring infection attempts at a number of hospitals, some of which may have beaten back infections. The FBI did not immediately respond to a request for comment.

He said the group was demanding exorbitant ransoms well above $10 million per target and that criminals involved on the dark web were discussing plans to try to infect more than 400 hospitals, clinics and other medical facilities.

“One of the comments from the bad guys is that they are expecting to cause panic and, no, they are not hitting election systems,” Holden said. “They are hitting where it hurts even more and they know it.” U.S. officials have repeatedly expressed concern about major

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Building wave of ransomware attacks strike U.S. hospitals

By Christopher Bing and Joseph Menn

WASHINGTON/SAN FRANCISCO (Reuters) – Eastern European criminals are targeting dozens of U.S. hospitals with ransomware, and federal officials on Wednesday urged healthcare facilities to beef up preparations rapidly in case they are next.

The FBI is investigating the recent attacks, which include incidents in Oregon, California and New York made public just this week, according to three cybersecurity consultants familiar with the matter.

A doctor at one hospital told Reuters that the facility was functioning on paper after an attack and unable to transfer patients because the nearest alternative was an hour away. The doctor declined to be named because staff were not authorized to speak with reporters.

“We can still watch vitals and getting imaging done, but all results are being communicated via paper only,” the doctor said. Staff could see historic records but not update those files.

Experts said the likely group behind the attacks was known as Wizard Spider or UNC 1878. They warned that such attacks can disrupt hospital operations and lead to loss of life.

The attacks prompted a teleconference call on Wednesday led by FBI and Homeland Security officials for hospital administrators and cybersecurity experts.

A participant told Reuters that government officials warned hospitals to make sure their backup systems were in order, disconnect systems from the internet where possible, and avoid using personal email accounts.

The FBI did not immediately respond to a request for comment.

“This appears to have been a coordinated attack designed to disrupt hospitals specifically all around the country,” said Allan Liska, a threat intelligence analyst with U.S. cybersecurity firm Recorded Future.

“While multiple ransomware attacks against healthcare providers each week have been commonplace, this is the first time we have seen six hospitals targeted in the same day by the same ransomware actor.”

In the past, ransomware infections at hospitals have downed patient record-keeping databases, which critically store up-to-date medical information, affecting hospitals’ ability to provide healthcare.

Ransomware attacks have jumped 50% over the past three months, security firm Check Point said Wednesday, with the proportion of polled healthcare organizations impacted jumping to 4% in the third quarter from 2.3% in the previous quarter.

Two of the three consultants familiar with the attacks said the cyber criminals were commonly using a type of ransomware known as “Ryuk,” which locks up a victim’s computer until a payment is received.

The teleconference call participant said government officials disclosed that the attackers used Ryuk and another trojan, known as Trickbot, against the hospitals.

“UNC1878 is one of the most brazen, heartless, and disruptive threat actors I’ve observed over my career,” said Charles Carmakal, senior vice president for U.S. cyber incident response firm Mandiant.

“Multiple hospitals have already been significantly impacted by Ryuk ransomware and their networks have been taken offline.”

Experts say the deployment of Trickbot is significant after efforts by Microsoft <MSFT.O> to disrupt the hacking network earlier this month.

That initiative was designed to handicap the cyber criminals, but they seem

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