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Global Ebola vaccine stockpile established
The International Coordinating Group (ICG) on Vaccine Provision announced the establishment of a global Ebola vaccine stockpile initiative.
The ICG, which was established in 1997, is made up of the World Health Organization, the United Nations Children’s Fund, the International Federation of Red Cross and Red Crescent Societies, and Médecins Sans Frontières.
The stockpile was created in order to make the single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live; trade name Everbo) rapidly available at the start of the next Ebola outbreak anywhere in the world. The vaccine was developed and is marketed by Merck Sharp & Dohme, with financial support from the United States.
The stockpile, which is maintained in Switzerland and managed by UNICEF, is designed to be readily deployed to other countries whenever there is an outbreak. The ICG will be the decision-making body for the vaccine’s allocation and release, as is also the case with previously created stockpiles of cholera, meningitis, and yellow fever vaccines.
“The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is 7 days,” according to the WHO press release.
Currently 6,890 doses are available for outbreak response, with further quantities to be delivered into the stockpile throughout 2021 and beyond. Initial use of the vaccine will be directed to health care and frontline workers. It is expected that it will take 2-3 years to reach the Strategic Advisory Group of Experts on Immunization–recommended level of 500,000 doses for the stockpile of Ebola vaccines.
The International Coordinating Group (ICG) on Vaccine Provision announced the establishment of a global Ebola vaccine stockpile initiative.
The ICG, which was established in 1997, is made up of the World Health Organization, the United Nations Children’s Fund, the International Federation of Red Cross and Red Crescent Societies, and Médecins Sans Frontières.
The stockpile was created in order to make the single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live; trade name Everbo) rapidly available at the start of the next Ebola outbreak anywhere in the world. The vaccine was developed and is marketed by Merck Sharp & Dohme, with financial support from the United States.
The stockpile, which is maintained in Switzerland and managed by UNICEF, is designed to be readily deployed to other countries whenever there is an outbreak. The ICG will be the decision-making body for the vaccine’s allocation and release, as is also the case with previously created stockpiles of cholera, meningitis, and yellow fever vaccines.
“The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is 7 days,” according to the WHO press release.
Currently 6,890 doses are available for outbreak response, with further quantities to be delivered into the stockpile throughout 2021 and beyond. Initial use of the vaccine will be directed to health care and frontline workers. It is expected that it will take 2-3 years to reach the Strategic Advisory Group of Experts on Immunization–recommended level of 500,000 doses for the stockpile of Ebola vaccines.
The International Coordinating Group (ICG) on Vaccine Provision announced the establishment of a global Ebola vaccine stockpile initiative.
The ICG, which was established in 1997, is made up of the World Health Organization, the United Nations Children’s Fund, the International Federation of Red Cross and Red Crescent Societies, and Médecins Sans Frontières.
The stockpile was created in order to make the single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live; trade name Everbo) rapidly available at the start of the next Ebola outbreak anywhere in the world. The vaccine was developed and is marketed by Merck Sharp & Dohme, with financial support from the United States.
The stockpile, which is maintained in Switzerland and managed by UNICEF, is designed to be readily deployed to other countries whenever there is an outbreak. The ICG will be the decision-making body for the vaccine’s allocation and release, as is also the case with previously created stockpiles of cholera, meningitis, and yellow fever vaccines.
“The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is 7 days,” according to the WHO press release.
Currently 6,890 doses are available for outbreak response, with further quantities to be delivered into the stockpile throughout 2021 and beyond. Initial use of the vaccine will be directed to health care and frontline workers. It is expected that it will take 2-3 years to reach the Strategic Advisory Group of Experts on Immunization–recommended level of 500,000 doses for the stockpile of Ebola vaccines.
Patients fend for themselves to access highly touted COVID antibody treatments
By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.
His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.
“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”
On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.
Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.
More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.
His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.
“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”
On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.
Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.
More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.
His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.
“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”
On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.
Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.
More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Biden’s COVID-19 challenge: 100 million vaccinations in the first 100 days. It won’t be easy.
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.
Many EM docs have treated COVID-19 patients without proper PPE: Survey
Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).
In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.
EM physicians were the physicians most likely to treat COVID-19 patients in person.
For comparison, among family medicine physicians, 58% said that they have treated COVID-19 patients in person, and 45% said they were treating them via telemedicine.
Data for the report were gathered from June 9 to July 20 as part of Medscape’s COVID-19 experience survey for all physicians. That survey drew more than 5,000 responses.
Nearly all (98%) of EM physicians who have treated COVID-19 patients said that they have done so since the beginning, when the World Health Organization declared a pandemic on March 11, 2020. For all U.S. physicians, the percentage was much higher than that – 73% said they had treated COVID-19 patients from the start.
EM physicians have often found themselves sacrificing their own safety for the sake of patients. More than half of EM physicians (54%) said that they had knowingly taken personal safety risks to treat a COVID-19 emergency, a percentage far higher than the 30% of all physicians who said they had done so.
Four percent of EM physicians have received a positive diagnosis of COVID-19 via testing. An additional 2% have been confirmed as having COVID on the basis of symptoms.
Steep income drops
Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.
Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.
Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.
More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
Grief and stress relief
Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.
The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.
Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.
Challenges to daily practice
By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.
Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”
COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.
More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.
A version of this article first appeared on Medscape.com.
Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).
In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.
EM physicians were the physicians most likely to treat COVID-19 patients in person.
For comparison, among family medicine physicians, 58% said that they have treated COVID-19 patients in person, and 45% said they were treating them via telemedicine.
Data for the report were gathered from June 9 to July 20 as part of Medscape’s COVID-19 experience survey for all physicians. That survey drew more than 5,000 responses.
Nearly all (98%) of EM physicians who have treated COVID-19 patients said that they have done so since the beginning, when the World Health Organization declared a pandemic on March 11, 2020. For all U.S. physicians, the percentage was much higher than that – 73% said they had treated COVID-19 patients from the start.
EM physicians have often found themselves sacrificing their own safety for the sake of patients. More than half of EM physicians (54%) said that they had knowingly taken personal safety risks to treat a COVID-19 emergency, a percentage far higher than the 30% of all physicians who said they had done so.
Four percent of EM physicians have received a positive diagnosis of COVID-19 via testing. An additional 2% have been confirmed as having COVID on the basis of symptoms.
Steep income drops
Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.
Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.
Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.
More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
Grief and stress relief
Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.
The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.
Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.
Challenges to daily practice
By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.
Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”
COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.
More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.
A version of this article first appeared on Medscape.com.
Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).
In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.
EM physicians were the physicians most likely to treat COVID-19 patients in person.
For comparison, among family medicine physicians, 58% said that they have treated COVID-19 patients in person, and 45% said they were treating them via telemedicine.
Data for the report were gathered from June 9 to July 20 as part of Medscape’s COVID-19 experience survey for all physicians. That survey drew more than 5,000 responses.
Nearly all (98%) of EM physicians who have treated COVID-19 patients said that they have done so since the beginning, when the World Health Organization declared a pandemic on March 11, 2020. For all U.S. physicians, the percentage was much higher than that – 73% said they had treated COVID-19 patients from the start.
EM physicians have often found themselves sacrificing their own safety for the sake of patients. More than half of EM physicians (54%) said that they had knowingly taken personal safety risks to treat a COVID-19 emergency, a percentage far higher than the 30% of all physicians who said they had done so.
Four percent of EM physicians have received a positive diagnosis of COVID-19 via testing. An additional 2% have been confirmed as having COVID on the basis of symptoms.
Steep income drops
Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.
Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.
Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.
More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
Grief and stress relief
Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.
The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.
Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.
Challenges to daily practice
By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.
Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”
COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.
More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.
A version of this article first appeared on Medscape.com.
Cardiometabolic Center Alliance promotes multiorgan, integrated T2D treatment
A one-stop shop approach to managing the spectrum of complications in patients with type 2 diabetes with a coordinated, multidisciplinary team of clinicians has taken root in at least two U.S. medical centers, and their efforts have now joined to take this concept national through the Cardiometabolic Center Alliance, which hopes to have at least 20 such centers running by the end of 2022.
In patients with type 2 diabetes (T2D), “multiple organs are affected by the same disease process,” notably the heart, kidneys, vasculature, and liver, but the care these patients often receive today is “fragmented, and typically without good coordination,” explained Mikhail N. Kosiborod, MD, a cardiologist and codirector of the Saint Luke’s Michael & Marlys Haverty Cardiometabolic Center of Excellence in Kansas City, Mo.
“We need to depart from the outdated idea that each medical specialty focuses on an organ system. It’s one patient with one disease that affects multiple organs and needs comprehensive, multidisciplinary care,” he said.
Historically, “we’ve looked to primary care physicians to ‘conduct the orchestra’ for complex, multispecialty care” for patients with T2D, but a recent “avalanche” of new treatments with new data and recommendations has made coordination by a single, generalist physician essentially impossible. “It isn’t realistic” to expect a single primary care physician to coordinate all the care a patient with T2D now needs to receive, said Dr. Kosiborod, who is also a professor of medicine at the University of Missouri–Kansas City. Plus, “patients can get lost” when they try to navigate on their own among several physicians, possibly in disparate locations, and without fully understanding what each physician is responsible for managing.
Application of recommended treatments ‘lagging’
“The data are there, and the recommendations are there for T2D and cardiovascular disease, heart failure, and diabetic kidney disease, but the problem has been implementation,” said Dr. Kosiborod. “Application in practice is lagging way behind the recommendations.” That led him and his associates to devise a “new model of care for patients with T2D,” the cardiometabolic center (CMC), as a status quo alternative.
The CMC paradigm is that patients with T2D, especially those with existing cardiovascular or chronic kidney disease or at high risk for these complications, undergo assessment and treatment at one site from a multidisciplinary staff of physicians and allied caregivers including nurse practitioners, nurse coordinators, pharmacists, dieticians, and diabetes educators who are cross-trained for managing both T2D and cardiovascular diseases.
The Cardiometabolic Center Alliance builds on the idea that this care model is defined by a set of detailed treatment protocols and processes of care that other sites can adopt to boost the number of patients aided by this approach, to gather data from a larger patient pool in a dedicated registry to better document the program’s impact, and to form a quality-improvement network that can collectively improve performance.
“It’s absolutely replicable,” maintained Dr. Kosiborod, who is also executive director of the Cardiometabolic Center Alliance. “We’ve codified all of the care and medications into an impressive package. We now have something that works, and many other centers are interested in building programs like this. By establishing a base of well-defined protocols and operating procedures we can train a cadre of allied professionals who can effectively implement the program across wider populations of patients, while using the brick and mortar center to manage more complex patients,” he added.
“We’re not taking patients” from primary care physicians, Dr. Kosiborod stressed. “We’re helping generalists give better care. They already have their hands full. We’re here to help physicians do better.”
He cited a recent study of 1,735 patients with atherosclerotic cardiovascular disease and diabetes (96% with T2D) enrolled in a registry at 119 U.S. sites during 2016-2018 that found less than 7% were on the full range of guideline-directed medical therapy that they qualified for based on existing treatment guidelines. “This is not acceptable,” Dr. Kosiborod declared.
“It’s so obvious that this needs to be a combined approach. It’s very difficult to have one provider take care of all of the T2D complications. There needs to be a new approach, and [the Cardiometabolic Center program at Saint Luke’s] has done a great job getting their initiative underway to take a more global approach,” commented Ralph A. DeFronzo, MD, chief of the diabetes division and professor of medicine at the University of Texas Health Science Center, San Antonio.
Early results show improved metrics
The Saint Luke’s Haverty CMC launched in 2019, and data from its first 129 patients with at least one follow-up visit documented early efficacy for the program, as reported at the American Heart Association’s Quality of Care and Outcome’s Research meeting, held virtually on May 15 and 16, 2020.
That analysis from Dr. Kosiborod and associates compared various short-term metrics among their CMC patients against a control cohort of 387 similar patients with T2D who also received care in the Saint Luke’s Health System during 2019 but outside of the CMC. This observational study involved no patient randomization, but the researchers used propensity scoring to match the control patients with those managed in the CMC by several demographic and clinical parameters.
During follow-up that was generally less than 6 months, patients managed in the CMC averaged 12 pounds of weight loss, a 0.5% reduction in their average hemoglobin A1c, a mean 4.6–mm Hg cut in their systolic blood pressure, an average drop in their LDL cholesterol of 11.4 mg/dL, and among those receiving insulin the daily, average insulin dose fell by a relative 43%, compared with baseline. Among the controls, averages for these five parameters were weight loss of 2 pounds, a cut in A1c of 0.2%, a systolic blood pressure reduction of 0.6 mm Hg, a drop in LDL cholesterol of 4.9 mg/dL, and a relative rise in insulin dose of 6%. All of these between group differences were statistically significant except for LDL cholesterol.
Additional analysis of the medications that patients in the CMC and control group received also showed striking differences. Combined prescriptions for all components of guideline-directed medical therapy went to 41% of the CMC patients, compared with 2% of the controls, a statistically significant difference. Contributing to this difference were significantly increased rates of prescriptions for ACE inhibitors and statins.
The CMC staff also started 57% of their patients on a SGLT2 inhibitor and 90% on a GLP-1 receptor agonist (GLP-1 RA), compared with rates of 18% and 13%, respectively, among controls. Both of these between-group differences were also significant, and they highlighted the willingness and success of the CMC clinicians to put a large number of their patients on agents from both of these beneficial drug classes. This is a notable change from usual recent practice that limits most patients who actually receive these medications to a drug from just one of these two classes, often because of real or perceived limits on insurance coverage.
The data from these initial patients in the Saint Luke’s CMC show that the program was “very successful; it looks very promising,” said Dr. Kosiborod. The results show “transformational improvement in the quality of care.” Subsequent to this initial cohort from 2019, the Saint Luke’s CMC has seen “hundreds” of additional patients with T2D.
The Cardiometabolic Center Alliance gets started
The second member of the Cardiometabolic Center Alliance is a program run by the University Hospitals system based in Cleveland that had begun earlier in 2020. The University Hospitals’ Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) uses a comprehensive, multidisciplinary-care model developed independently of but very similar to the Saint Luke’s CMC. By the end of 2020, the CINEMA program had managed about 150 patients, said Sanjay Rajagopalan, MD, director of CINEMA and a professor of medicine at Case Western Reserve University, Cleveland.
“Our outcomes have been quite similar” to what the Saint Luke’s program reported, he said. “We had better use of guideline-directed therapies, more weight loss, and better control of metabolic parameters.” The CINEMA program entered the Cardiometabolic Center Alliance as a “key strategic partner,” which means it will have a role in shaping the alliance going forward. One issue the alliance faces is how to leverage its growth to improve management of patients with T2D who do not have access to a CMC.
The CMCs “are not meant for every patient with T2D, but for those with high risk for cardiovascular complications who require extra attention,” Dr. Rajagopalan said in an interview. Both he and Dr. Kosiborod acknowledged that, even if 200 CMCs were to eventually open, and even if each center averaged 5,000 managed patients, those 1 million patients would be a small fraction of the total number of U.S. patients with T2D.
“Having these centers will produce a ripple effect. The protocols will percolate to primary care physicians,” Dr. Rajagopalan predicted. Once that happens, “not all patients will need to go to a cardiometabolic center.” In addition, leveraging established protocols via nurse coordinators and virtual care could bring this model to many more patients, Dr. Kosiborod noted.
By the end of 2020, a total of three additional U.S. centers had joined Saint Luke’s and University Hospitals in the alliance, but Dr. Kosiborod said that none of the three had yet been officially announced. The alliance has also started a national cardiometabolic registry, which will be “instrumental for its mission to track, benchmark, and improve quality of care and outcomes; enable mechanisms for “learning health care systems”; and can be used to answer important research questions,” Dr. Kosiborod said.
Combined SGLT2 inhibitor and GLP-1 RA treatment takes off
A key element of the more aggressive, risk-driven management emphasized in the CMC approach is frequent use of combined treatment with an SGLT2 inhibitor and a GLP-1 RA. Both classes of glucose-lowering drugs have well-documented, risk-reducing benefits, notably reduced atherosclerotic cardiovascular events and weight loss produced by the GLP1-RAs, and cuts in heart failure onset and hospitalizations and slowing of chronic kidney disease progression by the SGLT2 inhibitors.
Until now, medical society recommendations as well as opinion leaders have approached these two drug classes with a presumption that physicians would usually prescribe patients an agent from only one of these two classes, largely because the high cost of agents in both classes, all still under patent, often means coverage limits by insurers. Physicians at both the Saint Luke’s and University Hospitals programs have been more proactive, and successful, in prescribing agents from both classes to their high-risk patients with T2D.
“We use combination treatment quite a bit,” said Dr. Kosiborod. “It’s very sensible to use both. Their mechanisms of action are different and likely don’t overlap, so it’s reasonable to presume their activity is complimentary.” But he acknowledged that this has not yet been formally studied for cardiovascular or renal outcomes. Study results have documented complimentary effects between the two classes for weight loss, blood pressure reduction, and to some extent A1c reduction. A key reason for more frequent combined treatment with an SGLT2 inhibitor and GLP-1 RA is increased focus on the ability of both drug classes to lower risk in patients with T2D and high cardiovascular-disease risk, rather than prescribing decisions driven largely by trying to further reduce a patient’s A1c.
Although insurance coverage is not a given, the Saint Luke’s CMC has had good results using patient-assistance programs run by various drug companies. Some patients have received their medications free of charge or with modest copays, depending on their income and insurance coverage. At Saint Luke’s, “many” patients with T2D have been able to get free medications through assistance programs, he said. And for patients with health insurance, getting coverage for an agent from each class “is easier now than it was 3-4 years ago.”
Dr. Kosiborod has been a consultant to several companies, and has received research grants from AstraZeneca and Boehringer Ingelheim. Dr. DeFronzo received research grants from Astra Zeneca, Janssen, and Merck; he has been an adviser to AstraZeneca, Boehringer Ingelheim, Intarcia, Janssen, and Novo Nordisk; and he has been a speaker on behalf of AstraZeneca and Novo Nordisk. Dr. Rajagopalan has been a consultant to Novo Nordisk and Takeda.
A one-stop shop approach to managing the spectrum of complications in patients with type 2 diabetes with a coordinated, multidisciplinary team of clinicians has taken root in at least two U.S. medical centers, and their efforts have now joined to take this concept national through the Cardiometabolic Center Alliance, which hopes to have at least 20 such centers running by the end of 2022.
In patients with type 2 diabetes (T2D), “multiple organs are affected by the same disease process,” notably the heart, kidneys, vasculature, and liver, but the care these patients often receive today is “fragmented, and typically without good coordination,” explained Mikhail N. Kosiborod, MD, a cardiologist and codirector of the Saint Luke’s Michael & Marlys Haverty Cardiometabolic Center of Excellence in Kansas City, Mo.
“We need to depart from the outdated idea that each medical specialty focuses on an organ system. It’s one patient with one disease that affects multiple organs and needs comprehensive, multidisciplinary care,” he said.
Historically, “we’ve looked to primary care physicians to ‘conduct the orchestra’ for complex, multispecialty care” for patients with T2D, but a recent “avalanche” of new treatments with new data and recommendations has made coordination by a single, generalist physician essentially impossible. “It isn’t realistic” to expect a single primary care physician to coordinate all the care a patient with T2D now needs to receive, said Dr. Kosiborod, who is also a professor of medicine at the University of Missouri–Kansas City. Plus, “patients can get lost” when they try to navigate on their own among several physicians, possibly in disparate locations, and without fully understanding what each physician is responsible for managing.
Application of recommended treatments ‘lagging’
“The data are there, and the recommendations are there for T2D and cardiovascular disease, heart failure, and diabetic kidney disease, but the problem has been implementation,” said Dr. Kosiborod. “Application in practice is lagging way behind the recommendations.” That led him and his associates to devise a “new model of care for patients with T2D,” the cardiometabolic center (CMC), as a status quo alternative.
The CMC paradigm is that patients with T2D, especially those with existing cardiovascular or chronic kidney disease or at high risk for these complications, undergo assessment and treatment at one site from a multidisciplinary staff of physicians and allied caregivers including nurse practitioners, nurse coordinators, pharmacists, dieticians, and diabetes educators who are cross-trained for managing both T2D and cardiovascular diseases.
The Cardiometabolic Center Alliance builds on the idea that this care model is defined by a set of detailed treatment protocols and processes of care that other sites can adopt to boost the number of patients aided by this approach, to gather data from a larger patient pool in a dedicated registry to better document the program’s impact, and to form a quality-improvement network that can collectively improve performance.
“It’s absolutely replicable,” maintained Dr. Kosiborod, who is also executive director of the Cardiometabolic Center Alliance. “We’ve codified all of the care and medications into an impressive package. We now have something that works, and many other centers are interested in building programs like this. By establishing a base of well-defined protocols and operating procedures we can train a cadre of allied professionals who can effectively implement the program across wider populations of patients, while using the brick and mortar center to manage more complex patients,” he added.
“We’re not taking patients” from primary care physicians, Dr. Kosiborod stressed. “We’re helping generalists give better care. They already have their hands full. We’re here to help physicians do better.”
He cited a recent study of 1,735 patients with atherosclerotic cardiovascular disease and diabetes (96% with T2D) enrolled in a registry at 119 U.S. sites during 2016-2018 that found less than 7% were on the full range of guideline-directed medical therapy that they qualified for based on existing treatment guidelines. “This is not acceptable,” Dr. Kosiborod declared.
“It’s so obvious that this needs to be a combined approach. It’s very difficult to have one provider take care of all of the T2D complications. There needs to be a new approach, and [the Cardiometabolic Center program at Saint Luke’s] has done a great job getting their initiative underway to take a more global approach,” commented Ralph A. DeFronzo, MD, chief of the diabetes division and professor of medicine at the University of Texas Health Science Center, San Antonio.
Early results show improved metrics
The Saint Luke’s Haverty CMC launched in 2019, and data from its first 129 patients with at least one follow-up visit documented early efficacy for the program, as reported at the American Heart Association’s Quality of Care and Outcome’s Research meeting, held virtually on May 15 and 16, 2020.
That analysis from Dr. Kosiborod and associates compared various short-term metrics among their CMC patients against a control cohort of 387 similar patients with T2D who also received care in the Saint Luke’s Health System during 2019 but outside of the CMC. This observational study involved no patient randomization, but the researchers used propensity scoring to match the control patients with those managed in the CMC by several demographic and clinical parameters.
During follow-up that was generally less than 6 months, patients managed in the CMC averaged 12 pounds of weight loss, a 0.5% reduction in their average hemoglobin A1c, a mean 4.6–mm Hg cut in their systolic blood pressure, an average drop in their LDL cholesterol of 11.4 mg/dL, and among those receiving insulin the daily, average insulin dose fell by a relative 43%, compared with baseline. Among the controls, averages for these five parameters were weight loss of 2 pounds, a cut in A1c of 0.2%, a systolic blood pressure reduction of 0.6 mm Hg, a drop in LDL cholesterol of 4.9 mg/dL, and a relative rise in insulin dose of 6%. All of these between group differences were statistically significant except for LDL cholesterol.
Additional analysis of the medications that patients in the CMC and control group received also showed striking differences. Combined prescriptions for all components of guideline-directed medical therapy went to 41% of the CMC patients, compared with 2% of the controls, a statistically significant difference. Contributing to this difference were significantly increased rates of prescriptions for ACE inhibitors and statins.
The CMC staff also started 57% of their patients on a SGLT2 inhibitor and 90% on a GLP-1 receptor agonist (GLP-1 RA), compared with rates of 18% and 13%, respectively, among controls. Both of these between-group differences were also significant, and they highlighted the willingness and success of the CMC clinicians to put a large number of their patients on agents from both of these beneficial drug classes. This is a notable change from usual recent practice that limits most patients who actually receive these medications to a drug from just one of these two classes, often because of real or perceived limits on insurance coverage.
The data from these initial patients in the Saint Luke’s CMC show that the program was “very successful; it looks very promising,” said Dr. Kosiborod. The results show “transformational improvement in the quality of care.” Subsequent to this initial cohort from 2019, the Saint Luke’s CMC has seen “hundreds” of additional patients with T2D.
The Cardiometabolic Center Alliance gets started
The second member of the Cardiometabolic Center Alliance is a program run by the University Hospitals system based in Cleveland that had begun earlier in 2020. The University Hospitals’ Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) uses a comprehensive, multidisciplinary-care model developed independently of but very similar to the Saint Luke’s CMC. By the end of 2020, the CINEMA program had managed about 150 patients, said Sanjay Rajagopalan, MD, director of CINEMA and a professor of medicine at Case Western Reserve University, Cleveland.
“Our outcomes have been quite similar” to what the Saint Luke’s program reported, he said. “We had better use of guideline-directed therapies, more weight loss, and better control of metabolic parameters.” The CINEMA program entered the Cardiometabolic Center Alliance as a “key strategic partner,” which means it will have a role in shaping the alliance going forward. One issue the alliance faces is how to leverage its growth to improve management of patients with T2D who do not have access to a CMC.
The CMCs “are not meant for every patient with T2D, but for those with high risk for cardiovascular complications who require extra attention,” Dr. Rajagopalan said in an interview. Both he and Dr. Kosiborod acknowledged that, even if 200 CMCs were to eventually open, and even if each center averaged 5,000 managed patients, those 1 million patients would be a small fraction of the total number of U.S. patients with T2D.
“Having these centers will produce a ripple effect. The protocols will percolate to primary care physicians,” Dr. Rajagopalan predicted. Once that happens, “not all patients will need to go to a cardiometabolic center.” In addition, leveraging established protocols via nurse coordinators and virtual care could bring this model to many more patients, Dr. Kosiborod noted.
By the end of 2020, a total of three additional U.S. centers had joined Saint Luke’s and University Hospitals in the alliance, but Dr. Kosiborod said that none of the three had yet been officially announced. The alliance has also started a national cardiometabolic registry, which will be “instrumental for its mission to track, benchmark, and improve quality of care and outcomes; enable mechanisms for “learning health care systems”; and can be used to answer important research questions,” Dr. Kosiborod said.
Combined SGLT2 inhibitor and GLP-1 RA treatment takes off
A key element of the more aggressive, risk-driven management emphasized in the CMC approach is frequent use of combined treatment with an SGLT2 inhibitor and a GLP-1 RA. Both classes of glucose-lowering drugs have well-documented, risk-reducing benefits, notably reduced atherosclerotic cardiovascular events and weight loss produced by the GLP1-RAs, and cuts in heart failure onset and hospitalizations and slowing of chronic kidney disease progression by the SGLT2 inhibitors.
Until now, medical society recommendations as well as opinion leaders have approached these two drug classes with a presumption that physicians would usually prescribe patients an agent from only one of these two classes, largely because the high cost of agents in both classes, all still under patent, often means coverage limits by insurers. Physicians at both the Saint Luke’s and University Hospitals programs have been more proactive, and successful, in prescribing agents from both classes to their high-risk patients with T2D.
“We use combination treatment quite a bit,” said Dr. Kosiborod. “It’s very sensible to use both. Their mechanisms of action are different and likely don’t overlap, so it’s reasonable to presume their activity is complimentary.” But he acknowledged that this has not yet been formally studied for cardiovascular or renal outcomes. Study results have documented complimentary effects between the two classes for weight loss, blood pressure reduction, and to some extent A1c reduction. A key reason for more frequent combined treatment with an SGLT2 inhibitor and GLP-1 RA is increased focus on the ability of both drug classes to lower risk in patients with T2D and high cardiovascular-disease risk, rather than prescribing decisions driven largely by trying to further reduce a patient’s A1c.
Although insurance coverage is not a given, the Saint Luke’s CMC has had good results using patient-assistance programs run by various drug companies. Some patients have received their medications free of charge or with modest copays, depending on their income and insurance coverage. At Saint Luke’s, “many” patients with T2D have been able to get free medications through assistance programs, he said. And for patients with health insurance, getting coverage for an agent from each class “is easier now than it was 3-4 years ago.”
Dr. Kosiborod has been a consultant to several companies, and has received research grants from AstraZeneca and Boehringer Ingelheim. Dr. DeFronzo received research grants from Astra Zeneca, Janssen, and Merck; he has been an adviser to AstraZeneca, Boehringer Ingelheim, Intarcia, Janssen, and Novo Nordisk; and he has been a speaker on behalf of AstraZeneca and Novo Nordisk. Dr. Rajagopalan has been a consultant to Novo Nordisk and Takeda.
A one-stop shop approach to managing the spectrum of complications in patients with type 2 diabetes with a coordinated, multidisciplinary team of clinicians has taken root in at least two U.S. medical centers, and their efforts have now joined to take this concept national through the Cardiometabolic Center Alliance, which hopes to have at least 20 such centers running by the end of 2022.
In patients with type 2 diabetes (T2D), “multiple organs are affected by the same disease process,” notably the heart, kidneys, vasculature, and liver, but the care these patients often receive today is “fragmented, and typically without good coordination,” explained Mikhail N. Kosiborod, MD, a cardiologist and codirector of the Saint Luke’s Michael & Marlys Haverty Cardiometabolic Center of Excellence in Kansas City, Mo.
“We need to depart from the outdated idea that each medical specialty focuses on an organ system. It’s one patient with one disease that affects multiple organs and needs comprehensive, multidisciplinary care,” he said.
Historically, “we’ve looked to primary care physicians to ‘conduct the orchestra’ for complex, multispecialty care” for patients with T2D, but a recent “avalanche” of new treatments with new data and recommendations has made coordination by a single, generalist physician essentially impossible. “It isn’t realistic” to expect a single primary care physician to coordinate all the care a patient with T2D now needs to receive, said Dr. Kosiborod, who is also a professor of medicine at the University of Missouri–Kansas City. Plus, “patients can get lost” when they try to navigate on their own among several physicians, possibly in disparate locations, and without fully understanding what each physician is responsible for managing.
Application of recommended treatments ‘lagging’
“The data are there, and the recommendations are there for T2D and cardiovascular disease, heart failure, and diabetic kidney disease, but the problem has been implementation,” said Dr. Kosiborod. “Application in practice is lagging way behind the recommendations.” That led him and his associates to devise a “new model of care for patients with T2D,” the cardiometabolic center (CMC), as a status quo alternative.
The CMC paradigm is that patients with T2D, especially those with existing cardiovascular or chronic kidney disease or at high risk for these complications, undergo assessment and treatment at one site from a multidisciplinary staff of physicians and allied caregivers including nurse practitioners, nurse coordinators, pharmacists, dieticians, and diabetes educators who are cross-trained for managing both T2D and cardiovascular diseases.
The Cardiometabolic Center Alliance builds on the idea that this care model is defined by a set of detailed treatment protocols and processes of care that other sites can adopt to boost the number of patients aided by this approach, to gather data from a larger patient pool in a dedicated registry to better document the program’s impact, and to form a quality-improvement network that can collectively improve performance.
“It’s absolutely replicable,” maintained Dr. Kosiborod, who is also executive director of the Cardiometabolic Center Alliance. “We’ve codified all of the care and medications into an impressive package. We now have something that works, and many other centers are interested in building programs like this. By establishing a base of well-defined protocols and operating procedures we can train a cadre of allied professionals who can effectively implement the program across wider populations of patients, while using the brick and mortar center to manage more complex patients,” he added.
“We’re not taking patients” from primary care physicians, Dr. Kosiborod stressed. “We’re helping generalists give better care. They already have their hands full. We’re here to help physicians do better.”
He cited a recent study of 1,735 patients with atherosclerotic cardiovascular disease and diabetes (96% with T2D) enrolled in a registry at 119 U.S. sites during 2016-2018 that found less than 7% were on the full range of guideline-directed medical therapy that they qualified for based on existing treatment guidelines. “This is not acceptable,” Dr. Kosiborod declared.
“It’s so obvious that this needs to be a combined approach. It’s very difficult to have one provider take care of all of the T2D complications. There needs to be a new approach, and [the Cardiometabolic Center program at Saint Luke’s] has done a great job getting their initiative underway to take a more global approach,” commented Ralph A. DeFronzo, MD, chief of the diabetes division and professor of medicine at the University of Texas Health Science Center, San Antonio.
Early results show improved metrics
The Saint Luke’s Haverty CMC launched in 2019, and data from its first 129 patients with at least one follow-up visit documented early efficacy for the program, as reported at the American Heart Association’s Quality of Care and Outcome’s Research meeting, held virtually on May 15 and 16, 2020.
That analysis from Dr. Kosiborod and associates compared various short-term metrics among their CMC patients against a control cohort of 387 similar patients with T2D who also received care in the Saint Luke’s Health System during 2019 but outside of the CMC. This observational study involved no patient randomization, but the researchers used propensity scoring to match the control patients with those managed in the CMC by several demographic and clinical parameters.
During follow-up that was generally less than 6 months, patients managed in the CMC averaged 12 pounds of weight loss, a 0.5% reduction in their average hemoglobin A1c, a mean 4.6–mm Hg cut in their systolic blood pressure, an average drop in their LDL cholesterol of 11.4 mg/dL, and among those receiving insulin the daily, average insulin dose fell by a relative 43%, compared with baseline. Among the controls, averages for these five parameters were weight loss of 2 pounds, a cut in A1c of 0.2%, a systolic blood pressure reduction of 0.6 mm Hg, a drop in LDL cholesterol of 4.9 mg/dL, and a relative rise in insulin dose of 6%. All of these between group differences were statistically significant except for LDL cholesterol.
Additional analysis of the medications that patients in the CMC and control group received also showed striking differences. Combined prescriptions for all components of guideline-directed medical therapy went to 41% of the CMC patients, compared with 2% of the controls, a statistically significant difference. Contributing to this difference were significantly increased rates of prescriptions for ACE inhibitors and statins.
The CMC staff also started 57% of their patients on a SGLT2 inhibitor and 90% on a GLP-1 receptor agonist (GLP-1 RA), compared with rates of 18% and 13%, respectively, among controls. Both of these between-group differences were also significant, and they highlighted the willingness and success of the CMC clinicians to put a large number of their patients on agents from both of these beneficial drug classes. This is a notable change from usual recent practice that limits most patients who actually receive these medications to a drug from just one of these two classes, often because of real or perceived limits on insurance coverage.
The data from these initial patients in the Saint Luke’s CMC show that the program was “very successful; it looks very promising,” said Dr. Kosiborod. The results show “transformational improvement in the quality of care.” Subsequent to this initial cohort from 2019, the Saint Luke’s CMC has seen “hundreds” of additional patients with T2D.
The Cardiometabolic Center Alliance gets started
The second member of the Cardiometabolic Center Alliance is a program run by the University Hospitals system based in Cleveland that had begun earlier in 2020. The University Hospitals’ Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) uses a comprehensive, multidisciplinary-care model developed independently of but very similar to the Saint Luke’s CMC. By the end of 2020, the CINEMA program had managed about 150 patients, said Sanjay Rajagopalan, MD, director of CINEMA and a professor of medicine at Case Western Reserve University, Cleveland.
“Our outcomes have been quite similar” to what the Saint Luke’s program reported, he said. “We had better use of guideline-directed therapies, more weight loss, and better control of metabolic parameters.” The CINEMA program entered the Cardiometabolic Center Alliance as a “key strategic partner,” which means it will have a role in shaping the alliance going forward. One issue the alliance faces is how to leverage its growth to improve management of patients with T2D who do not have access to a CMC.
The CMCs “are not meant for every patient with T2D, but for those with high risk for cardiovascular complications who require extra attention,” Dr. Rajagopalan said in an interview. Both he and Dr. Kosiborod acknowledged that, even if 200 CMCs were to eventually open, and even if each center averaged 5,000 managed patients, those 1 million patients would be a small fraction of the total number of U.S. patients with T2D.
“Having these centers will produce a ripple effect. The protocols will percolate to primary care physicians,” Dr. Rajagopalan predicted. Once that happens, “not all patients will need to go to a cardiometabolic center.” In addition, leveraging established protocols via nurse coordinators and virtual care could bring this model to many more patients, Dr. Kosiborod noted.
By the end of 2020, a total of three additional U.S. centers had joined Saint Luke’s and University Hospitals in the alliance, but Dr. Kosiborod said that none of the three had yet been officially announced. The alliance has also started a national cardiometabolic registry, which will be “instrumental for its mission to track, benchmark, and improve quality of care and outcomes; enable mechanisms for “learning health care systems”; and can be used to answer important research questions,” Dr. Kosiborod said.
Combined SGLT2 inhibitor and GLP-1 RA treatment takes off
A key element of the more aggressive, risk-driven management emphasized in the CMC approach is frequent use of combined treatment with an SGLT2 inhibitor and a GLP-1 RA. Both classes of glucose-lowering drugs have well-documented, risk-reducing benefits, notably reduced atherosclerotic cardiovascular events and weight loss produced by the GLP1-RAs, and cuts in heart failure onset and hospitalizations and slowing of chronic kidney disease progression by the SGLT2 inhibitors.
Until now, medical society recommendations as well as opinion leaders have approached these two drug classes with a presumption that physicians would usually prescribe patients an agent from only one of these two classes, largely because the high cost of agents in both classes, all still under patent, often means coverage limits by insurers. Physicians at both the Saint Luke’s and University Hospitals programs have been more proactive, and successful, in prescribing agents from both classes to their high-risk patients with T2D.
“We use combination treatment quite a bit,” said Dr. Kosiborod. “It’s very sensible to use both. Their mechanisms of action are different and likely don’t overlap, so it’s reasonable to presume their activity is complimentary.” But he acknowledged that this has not yet been formally studied for cardiovascular or renal outcomes. Study results have documented complimentary effects between the two classes for weight loss, blood pressure reduction, and to some extent A1c reduction. A key reason for more frequent combined treatment with an SGLT2 inhibitor and GLP-1 RA is increased focus on the ability of both drug classes to lower risk in patients with T2D and high cardiovascular-disease risk, rather than prescribing decisions driven largely by trying to further reduce a patient’s A1c.
Although insurance coverage is not a given, the Saint Luke’s CMC has had good results using patient-assistance programs run by various drug companies. Some patients have received their medications free of charge or with modest copays, depending on their income and insurance coverage. At Saint Luke’s, “many” patients with T2D have been able to get free medications through assistance programs, he said. And for patients with health insurance, getting coverage for an agent from each class “is easier now than it was 3-4 years ago.”
Dr. Kosiborod has been a consultant to several companies, and has received research grants from AstraZeneca and Boehringer Ingelheim. Dr. DeFronzo received research grants from Astra Zeneca, Janssen, and Merck; he has been an adviser to AstraZeneca, Boehringer Ingelheim, Intarcia, Janssen, and Novo Nordisk; and he has been a speaker on behalf of AstraZeneca and Novo Nordisk. Dr. Rajagopalan has been a consultant to Novo Nordisk and Takeda.
Women physicians and the pandemic: A snapshot
“Women physicians do not have trouble balancing competing demands any more than men physicians do. It is simply a more common expectation that women physicians will adjust their professional lives,” she observed.
The daily grind of caring for patients during a global pandemic is taking an emotional and mental toll on doctors as well as a physical one. “The recently publicized suicide of emergency physician Lorna Breen, MD, following her intense work during the pandemic in New York should cause every physician to reflect on their culture in medicine,” Dr. Brubaker wrote in the article. In an interview, she expounded on the current climate for women psychiatrists and physicians in general, offering some coping techniques.
Question: The pandemic has amplified disparities among men and women physicians. What may be the repercussions from this, not just for patient care, but for work-life balance among women physicians?
Answer: Focusing on women in academic roles, both research and clinical productivity have changed in the professional arena. Many women continue to bear a disproportionate share of family responsibilities and have reduced paid work to accommodate these needs. These changes can impact academic promotion and, therefore, subsequent academic opportunities for leadership. These gaps will add to the well-recognized gender wage gap. Women physicians are more likely to experience reduced wages associated with reduced professional activities. This reduces their annual earnings, which reduces their contributions to Social Security and other retirement programs. This can adversely impact their financial security later in life, at a time when women are already disadvantaged, compared with men.
Q: Are women psychiatrists facing additional burdens, given that many patients are suffering from anxiety and depression right now, and seeking out prescriptions?
A: We know that mental health concerns are on the rise. Although I cannot point to specific evidence, as a result. Similar to those on the more well-recognized “front lines” in the ED and critical care units, I consider my psychiatric colleagues to be on the front lines as well, as they are addressing this marked increase in care needs, for patients and for other members of the health care team.
Q: You mentioned the suicide of Dr. Breen. What might women psychiatrists take away from this incident?
A: Physicians are drawn to our vocation with a commitment to be of service to others. During such demanding times as these, the “safety” rails between service to others and self-care shift – clearly this can endanger individual doctors.
Q: What advice might you have for women in this profession? Any resources that could provide support?
A: My advice is to ensure your own well-being, knowing that this differs for each woman. Be realistic with your time and commitments, allowing time for restoration and rest. Sometimes I tell my peers to meditate or do some other form of contemplative practice. Exercise (preferably outdoors) and sleep, including preparing for good sleep, such as not reading emails or patient charts right up until sleep time, are all important. Most importantly, identify your support team and check in regularly with them. Never hesitate to reach out for help. People truly do care and want to help you.
“Women physicians do not have trouble balancing competing demands any more than men physicians do. It is simply a more common expectation that women physicians will adjust their professional lives,” she observed.
The daily grind of caring for patients during a global pandemic is taking an emotional and mental toll on doctors as well as a physical one. “The recently publicized suicide of emergency physician Lorna Breen, MD, following her intense work during the pandemic in New York should cause every physician to reflect on their culture in medicine,” Dr. Brubaker wrote in the article. In an interview, she expounded on the current climate for women psychiatrists and physicians in general, offering some coping techniques.
Question: The pandemic has amplified disparities among men and women physicians. What may be the repercussions from this, not just for patient care, but for work-life balance among women physicians?
Answer: Focusing on women in academic roles, both research and clinical productivity have changed in the professional arena. Many women continue to bear a disproportionate share of family responsibilities and have reduced paid work to accommodate these needs. These changes can impact academic promotion and, therefore, subsequent academic opportunities for leadership. These gaps will add to the well-recognized gender wage gap. Women physicians are more likely to experience reduced wages associated with reduced professional activities. This reduces their annual earnings, which reduces their contributions to Social Security and other retirement programs. This can adversely impact their financial security later in life, at a time when women are already disadvantaged, compared with men.
Q: Are women psychiatrists facing additional burdens, given that many patients are suffering from anxiety and depression right now, and seeking out prescriptions?
A: We know that mental health concerns are on the rise. Although I cannot point to specific evidence, as a result. Similar to those on the more well-recognized “front lines” in the ED and critical care units, I consider my psychiatric colleagues to be on the front lines as well, as they are addressing this marked increase in care needs, for patients and for other members of the health care team.
Q: You mentioned the suicide of Dr. Breen. What might women psychiatrists take away from this incident?
A: Physicians are drawn to our vocation with a commitment to be of service to others. During such demanding times as these, the “safety” rails between service to others and self-care shift – clearly this can endanger individual doctors.
Q: What advice might you have for women in this profession? Any resources that could provide support?
A: My advice is to ensure your own well-being, knowing that this differs for each woman. Be realistic with your time and commitments, allowing time for restoration and rest. Sometimes I tell my peers to meditate or do some other form of contemplative practice. Exercise (preferably outdoors) and sleep, including preparing for good sleep, such as not reading emails or patient charts right up until sleep time, are all important. Most importantly, identify your support team and check in regularly with them. Never hesitate to reach out for help. People truly do care and want to help you.
“Women physicians do not have trouble balancing competing demands any more than men physicians do. It is simply a more common expectation that women physicians will adjust their professional lives,” she observed.
The daily grind of caring for patients during a global pandemic is taking an emotional and mental toll on doctors as well as a physical one. “The recently publicized suicide of emergency physician Lorna Breen, MD, following her intense work during the pandemic in New York should cause every physician to reflect on their culture in medicine,” Dr. Brubaker wrote in the article. In an interview, she expounded on the current climate for women psychiatrists and physicians in general, offering some coping techniques.
Question: The pandemic has amplified disparities among men and women physicians. What may be the repercussions from this, not just for patient care, but for work-life balance among women physicians?
Answer: Focusing on women in academic roles, both research and clinical productivity have changed in the professional arena. Many women continue to bear a disproportionate share of family responsibilities and have reduced paid work to accommodate these needs. These changes can impact academic promotion and, therefore, subsequent academic opportunities for leadership. These gaps will add to the well-recognized gender wage gap. Women physicians are more likely to experience reduced wages associated with reduced professional activities. This reduces their annual earnings, which reduces their contributions to Social Security and other retirement programs. This can adversely impact their financial security later in life, at a time when women are already disadvantaged, compared with men.
Q: Are women psychiatrists facing additional burdens, given that many patients are suffering from anxiety and depression right now, and seeking out prescriptions?
A: We know that mental health concerns are on the rise. Although I cannot point to specific evidence, as a result. Similar to those on the more well-recognized “front lines” in the ED and critical care units, I consider my psychiatric colleagues to be on the front lines as well, as they are addressing this marked increase in care needs, for patients and for other members of the health care team.
Q: You mentioned the suicide of Dr. Breen. What might women psychiatrists take away from this incident?
A: Physicians are drawn to our vocation with a commitment to be of service to others. During such demanding times as these, the “safety” rails between service to others and self-care shift – clearly this can endanger individual doctors.
Q: What advice might you have for women in this profession? Any resources that could provide support?
A: My advice is to ensure your own well-being, knowing that this differs for each woman. Be realistic with your time and commitments, allowing time for restoration and rest. Sometimes I tell my peers to meditate or do some other form of contemplative practice. Exercise (preferably outdoors) and sleep, including preparing for good sleep, such as not reading emails or patient charts right up until sleep time, are all important. Most importantly, identify your support team and check in regularly with them. Never hesitate to reach out for help. People truly do care and want to help you.
Further warning on SGLT2 inhibitor use and DKA risk in COVID-19
a new case series suggests.
Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.
“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.
Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”
These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.
“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”
On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.”
Pay special attention to the elderly, those with complications
However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.
The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.
With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.
In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.
The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.
None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.
Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.
A version of this article first appeared on Medscape.com.
a new case series suggests.
Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.
“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.
Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”
These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.
“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”
On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.”
Pay special attention to the elderly, those with complications
However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.
The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.
With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.
In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.
The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.
None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.
Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.
A version of this article first appeared on Medscape.com.
a new case series suggests.
Five patients with type 2 diabetes who were taking SGLT2 inhibitors presented in DKA despite having glucose levels below 300 mg/dL. The report was published online last month in AACE Clinical Case Reports by Rebecca J. Vitale, MD, and colleagues at Brigham and Women’s Hospital, Boston.
“A cluster of euglycemic DKA cases at our hospital during the first wave of the pandemic suggests that patients with diabetes taking SGLT2 inhibitors may be at enhanced risk for euDKA when they contract COVID-19,” senior author Naomi D.L. Fisher, MD, said in an interview.
Dr. Fisher, an endocrinologist, added: “This complication is preventable with the simple measure of holding the drug. We are hopeful that widespread patient and physician education will prevent future cases of euDKA as COVID-19 infections continue to surge.”
These cases underscore recommendations published early in the COVID-19 pandemic by an international panel, she noted.
“Patients who are acutely ill with nausea, vomiting, abdominal pain, or diarrhea, or who are experiencing loss of appetite with reduced food and fluid intake, should be advised to hold their SGLT2 inhibitor. This medication should not be resumed until patients are feeling better and eating and drinking normally.”
On the other hand, “If patients with asymptomatic or mild COVID-19 infection are otherwise well, and are eating and drinking normally, there is no evidence that SGLT2 inhibitors need to be stopped. These patients should monitor [themselves] closely for worsening symptoms, especially resulting in poor hydration and nutrition, which would be reason to discontinue their medication.”
Pay special attention to the elderly, those with complications
However, special consideration should be given to elderly patients and those with medical conditions known to increase the likelihood of severe infection, like heart failure and chronic obstructive pulmonary disease, Dr. Fisher added.
The SGLT2 inhibitor class of drugs causes significant urinary glucose excretion, and they are also diuretics. A decrease in available glucose and volume depletion are probably both important contributors to euDKA, she explained.
With COVID-19 infection the euDKA risk is compounded by several mechanisms. Most cases of euDKA are associated with an underlying state of starvation that can be triggered by vomiting, diarrhea, loss of appetite, and poor oral intake.
In addition – although not yet known for certain – SARS-CoV-2 may also be toxic to pancreatic beta cells and thus reduce insulin secretion. The maladaptive inflammatory response seen with COVID-19 may also contribute, she said.
The patients in the current case series were three men and two women seen between March and May 2020. They ranged in age from 52 to 79 years.
None had a prior history of DKA or any known diabetes complications. In all of them, antihyperglycemic medications, including SGLT2 inhibitors, were stopped on hospital admission. The patients were initially treated with intravenous insulin, and then subcutaneous insulin after the DKA diagnosis.
Three of the patients were discharged to rehabilitation facilities on hospital days 28-47 and one (age 53 years) was discharged home on day 11. The other patient also had hypertension and nonalcoholic steatohepatitis.
A version of this article first appeared on Medscape.com.
Women psychiatrists struggle to balance work-life demands during COVID-19
Daily life is now a juggling act for Misty Richards, MD, MS. As the program director of a rigorous child psychiatry fellowship, a psychiatrist caring for women with perinatal psychiatric disorders, and the mother of three young children, Dr. Richards tries to view these tasks as an opportunity for growth. But some days it feels as if she’s navigating a storm in the middle of the ocean without a life jacket.
In the age of COVID, “the wave of demands has morphed into one giant tidal wave of desperate need,” Dr. Richards, of the department of psychiatry & biobehavioral sciences, University of California, Los Angeles, Semel Institute of Neuroscience & Human Behavior, said in an interview. “The painfully loud and clear message is that our patients need us, and our children – who have been stripped from healthy routines and peer interactions that nourish social-emotional development – rely on us. We cannot turn our backs for even a moment, or else they will suffer.”
Tasked with caring for a much sicker and distressed population, navigating home duties such as child care, online school, and taking care of certain family members, women psychiatrists are feeling the impact of COVID-19.
Many have seamlessly transferred their practices online, maintaining a lifeline with their patients through telehealth visits. Even with this convenience, the emotional labor of being a psychiatrist is still very stressful, Pooja Lakshmin, MD, of the department of psychiatry and behavioral sciences at George Washington University, Washington, said in an interview. Because the nature of work has changed, and many are doing things virtually at home, separating home from work life can be a challenge. “It’s harder to disconnect,” admitted Dr. Lakshmin. “Even my patients tell me that they have no time to themselves anymore.”
– a moving target that remains nowhere in sight, Dr. Richards said. “In this process, we are expected to fill the emotional cups of a broken nation, to provide answers that do not exist, and to do so with never-ending gratitude for a demanding system that has no ‘off’ switch,” she noted.
‘In two places at once’
COVID-19’s physical and emotional toll has swept across the various subspecialties of clinical psychiatry. As some navigate outpatient/telehealth work, inpatient psychiatrists directly interact with COVID patients.
“Our inpatient psychiatry unit regularly takes care of COVID patients, including perinatal patients who are COVID positive,” Samantha Meltzer-Brody, MD, MPH, distinguished professor and chair, University of North Carolina, Chapel Hill, department of psychiatry and director of medical school’s Center for Women’s Mood Disorders, said in an interview. A psychiatry consultation-liaison service also provides psychiatry care to medical and surgical patients, including medically ill COVID patients across the hospital.
“We are on the front lines in the sense that we are dealing with the trauma of the general population and having to be present for that emotional distress,” Dr. Meltzer-Brody said.
The struggle to balance rising caseloads and home responsibilities makes things difficult, she continued. “There’s a never-ending onslaught of patient referrals,” reflecting the anxiety and depression issues people are experiencing in the wake of a global pandemic, frenetic political situation in the United States, and job uncertainty.
Child care and elder care responsibilities affect both men and women, yet research shows that caregiving demands disproportionately affect women, observed Dr. Meltzer-Brody.
Overall, the stress of caregiving and parenting responsibilities for men and women has been markedly higher during the pandemic. Most clinical psychiatrists “have been extraordinarily busy for a very long time,” she added.
Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., has seen an increase in anxiety and depression in people with no previous history of diagnosed mental illness. “The impact of the pandemic has truly been multifaceted. People are struggling with loss of jobs, loss of wages, and loss of loved ones, along with grieving the loss of the usual way of life,” she said in an interview.
Many of her colleagues report feeling overburdened at work with increased admissions and patient loads, decreased time to see each patient, and the feeling of “needing to be in two places at once.”
“As a female psychiatrist, I do believe that we can sometimes have an increased mental burden due to the emotional and physical burnout that can occur when our routines are shaken,” added Dr. Bell, who specializes in adult, child, and adolescent psychiatry, and obesity and lifestyle medicine. Even in the early months of the pandemic, Dr. Bell said she heard people joke that “they don’t know if they are working from home or living at work.”
Physicians aren’t the only ones who are overwhelmed. “We’re also hearing stories from our patients – those at risk for partner violence, dealing with kids out of school, working full time while providing support at home,” Ludmila De Faria, MD, chair of the American Psychiatric Association’s Committee on Women’s Mental Health, said in an interview.
American mothers in particular spend nearly twice as much time caring for their children and cooking than their spouses, said Dr. Bell, citing recent studies. “Even if one is not a mom, if you couple the increased housework at baseline with the added responsibilities of working as a front-line physician and/or working from home while managing a household, it can lead to increased stress for all involved.”
Women leaving the workforce
Nationally, a growing number of women are either reducing their hours or leaving the workforce in response to the pandemic. Fidelity Investments, which surveyed 1,902 U.S. adults in mid-2020 projected that 4 in 10 women were mulling such options. Among 951 women surveyed, 42% were considering stepping back from their jobs because of their children’s homeschooling needs, and 27% cited difficulties of balancing home and job responsibilities.
Interruptions caused by child care affect women more than men, according to a report from the Century Foundation and the Center for American Progress. “Study after study has shown that, in response to school, child care, and camp closings, as well as reduced hours and reduced class sizes, significantly more women than men have reduced their work hours, left work to care for children, and spent more time on education and household tasks,” the authors noted.
They estimated that the American economy could incur $64.5 billion per year in lost wages and economic activity from the fallout of these trends. In September 2020, four times as many women as men left the workforce, nearly 865,000 women in comparison to 216,000 men.
Many women psychiatrists have been forced to choose between their careers or child care duties – decisions they don’t want to make, but that may be necessary during these unprecedented circumstances. They may be reducing their work hours to assist at home. Others are leaving their jobs, “a terrible situation given the enormous mental health needs of the pandemic” and the fact that so many areas of the United States already suffer from a shortage of clinical psychiatrists, said Dr. Meltzer-Brody.
She has personally seen the effects of this in the large academic department she supervises. “I’m seeing women reducing their work hours or leave positions,” she continued. In addition to child care needs, these women are tending to aging parents affected by COVID-19 or other illnesses, or dealing with the fact that options for elder care aren’t available.
“I have multiple faculty contending with that situation,” added Dr. Meltzer-Brody. As a result, productivity is going down. “These women are trying to keep all of the balls in the air but find they can’t.”
Dr. Richards believes some changes are in order to take the disproportionate burden off of women in psychiatry, and the workforce as a whole. The health care system “places too much pressure on individuals to compensate for its deficiencies. Those individuals who often step up to the plate are women, and this is not their sole burden to carry.”
A move toward telehealth in clinical psychiatry has made it possible for patients and physicians to meet virtually in their respective homes and discuss treatment options. “Even while this is both a blessing and privilege, it comes with the unique challenges of having to manage Zoom calls, child care, meals, distance learning, cleaning, and work responsibilities, while previously there was a clearer delineation to the day for many,” Dr. Bell said.
Clinical psychiatrists educating the public about the mental stressors of COVID-19 face their own unique challenges.
Dr. Lakshmin, who makes appearances in various media and social media outlets, said this adds more pressure to the job. “One of the challenges for me is to figure out how much outward facing I do. That’s hard when you’re navigating working and living through a pandemic. This is something I do because I enjoy doing it. But it’s still a type of work. And it’s certainly increased because the media has been paying more attention to mental health” since the pandemic started, she added.
The dual stress of COVID and social justice
Some women psychiatrists of color are dealing with social justice issues on top of other COVID stressors, Dr. De Faria said. The focus on addressing institutionalized racism means that minority women are taking on extra work to advocate for their peers.
Michelle Jacobs-Elliott, MD, of the department of psychiatry and assistant dean of the Office of Diversity and Health Equity at the University of Florida, Gainesville, knows of such responsibilities. “I have been in many discussions either with my coworkers in my department or others who work for the University of Florida” on systemic racism, she said in an interview.
Dr. Jacobs-Elliott became a trainer for Bias Reduction in Internal Medicine, a workshop aimed at reducing bias, and prior to 2020 participated in a social justice summit at the University of Florida. “Talking with my medical as well as undergraduate students about their experiences both here in Gainesville and elsewhere, they are all feeling the hurt, disappointment, and disbelief that we are still fighting battles that our grandparents fought in health care, housing, and employment. This adds an extra layer of stress to everyone’s life.”
The tense social climate has made the apparent racial inequalities in COVID-19 deaths and severity of disease hard to ignore, Dr. Bell noted. “It is my sincere hope that the availability of COVID-19 vaccines will help decrease the number of people affected by this horrible disease. The added burden of racism on top of the stressors of this pandemic can feel insurmountable. I hope 2021 will provide a way forward for us all.”
Taking time for self-care
Amid the endless referrals and increasing demands at home, women psychiatrists often don’t have the time to do normal activities, Dr. Meltzer-Brody observed. Like most people, COVID restrictions prevent them from traveling or going to the gym or restaurants. Dr. De Faria has not been able to visit family in Latin America, a trip she used to make twice a year. “That was once my de-stress time. But now, I can’t connect with my roots. My father is elderly and very much at risk.”
This is the time to get creative and resourceful – to make time for self-care, several sources said.
“We need to realize that we cannot be all things to all people, at the same time,” noted Dr. Bell. It’s important to prioritize what’s most important – and keep assessing your priorities. There’s no shame in tending to your own needs. Dr. Bell recommended that women in her profession should pick 1 day a week, put it in their calendar, and stick to this goal of self-care.
“Even if it’s only 15 minutes, it is important to put time aside. Some quick, cheap ideas are to do a quick meditation session, read a chapter in a book, listen to an audiobook, journal, go for a walk and get fresh air. Eat a healthy meal. Even 10 minutes helps,” she urged.
COVID-19 has pushed society to find new ways to do things, Dr. Bell continued. Women psychiatrists, in assessing their work-life balance, may need to reassess their goals. Consider work schedules and see if there’s a place to scale back a task. Delegate tasks at home to family members, if necessary. Most importantly, exercise self-compassion, she stressed. “During this pandemic, I believe it is vital to keep our cups filled so we can pour into others.”
Dr. Lakshmin said she has benefited greatly from having a therapist during the pandemic. “It has been so instrumental in forcing me to take that time for myself, to give me a space to take care of me, and remember it’s okay to take care of me. It’s so important for us as psychiatrists to have that for ourselves. It’s not just for our patients – we need it, too.”
The APA has resources and numerous support groups that meet regularly to address and discuss the stressors of the pandemic. Its College Mental Health Caucus, for example, holds a monthly, hour-long Zoom meeting. Not surprisingly, women comprise the majority of attendees, Dr. De Faria said. “Most women in academic psychiatry are working from home and using telehealth, which isolates people a lot.” Maureen Sayres Van Niel, MD, who is head of the APA’s Women’s Caucus, sends out a regular newsletter that advises on self-care. Women psychiatrists should also contact their local psychiatric organizations to get support from their professional peers.
Sometimes it’s wise to leave work behind and engage with friends. Dr. De Faria regularly Zooms with a group of friends outside of her profession to de-stress and reconnect. “At least I can talk to them about things other than psychiatry.”
Mentally and physically exhausted, Dr. Jacobs-Elliott said she looks forward to the day when society can return to meeting with friends and family “without being afraid that we are an asymptomatic carrier who is infecting our loved ones.”
Daily life is now a juggling act for Misty Richards, MD, MS. As the program director of a rigorous child psychiatry fellowship, a psychiatrist caring for women with perinatal psychiatric disorders, and the mother of three young children, Dr. Richards tries to view these tasks as an opportunity for growth. But some days it feels as if she’s navigating a storm in the middle of the ocean without a life jacket.
In the age of COVID, “the wave of demands has morphed into one giant tidal wave of desperate need,” Dr. Richards, of the department of psychiatry & biobehavioral sciences, University of California, Los Angeles, Semel Institute of Neuroscience & Human Behavior, said in an interview. “The painfully loud and clear message is that our patients need us, and our children – who have been stripped from healthy routines and peer interactions that nourish social-emotional development – rely on us. We cannot turn our backs for even a moment, or else they will suffer.”
Tasked with caring for a much sicker and distressed population, navigating home duties such as child care, online school, and taking care of certain family members, women psychiatrists are feeling the impact of COVID-19.
Many have seamlessly transferred their practices online, maintaining a lifeline with their patients through telehealth visits. Even with this convenience, the emotional labor of being a psychiatrist is still very stressful, Pooja Lakshmin, MD, of the department of psychiatry and behavioral sciences at George Washington University, Washington, said in an interview. Because the nature of work has changed, and many are doing things virtually at home, separating home from work life can be a challenge. “It’s harder to disconnect,” admitted Dr. Lakshmin. “Even my patients tell me that they have no time to themselves anymore.”
– a moving target that remains nowhere in sight, Dr. Richards said. “In this process, we are expected to fill the emotional cups of a broken nation, to provide answers that do not exist, and to do so with never-ending gratitude for a demanding system that has no ‘off’ switch,” she noted.
‘In two places at once’
COVID-19’s physical and emotional toll has swept across the various subspecialties of clinical psychiatry. As some navigate outpatient/telehealth work, inpatient psychiatrists directly interact with COVID patients.
“Our inpatient psychiatry unit regularly takes care of COVID patients, including perinatal patients who are COVID positive,” Samantha Meltzer-Brody, MD, MPH, distinguished professor and chair, University of North Carolina, Chapel Hill, department of psychiatry and director of medical school’s Center for Women’s Mood Disorders, said in an interview. A psychiatry consultation-liaison service also provides psychiatry care to medical and surgical patients, including medically ill COVID patients across the hospital.
“We are on the front lines in the sense that we are dealing with the trauma of the general population and having to be present for that emotional distress,” Dr. Meltzer-Brody said.
The struggle to balance rising caseloads and home responsibilities makes things difficult, she continued. “There’s a never-ending onslaught of patient referrals,” reflecting the anxiety and depression issues people are experiencing in the wake of a global pandemic, frenetic political situation in the United States, and job uncertainty.
Child care and elder care responsibilities affect both men and women, yet research shows that caregiving demands disproportionately affect women, observed Dr. Meltzer-Brody.
Overall, the stress of caregiving and parenting responsibilities for men and women has been markedly higher during the pandemic. Most clinical psychiatrists “have been extraordinarily busy for a very long time,” she added.
Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., has seen an increase in anxiety and depression in people with no previous history of diagnosed mental illness. “The impact of the pandemic has truly been multifaceted. People are struggling with loss of jobs, loss of wages, and loss of loved ones, along with grieving the loss of the usual way of life,” she said in an interview.
Many of her colleagues report feeling overburdened at work with increased admissions and patient loads, decreased time to see each patient, and the feeling of “needing to be in two places at once.”
“As a female psychiatrist, I do believe that we can sometimes have an increased mental burden due to the emotional and physical burnout that can occur when our routines are shaken,” added Dr. Bell, who specializes in adult, child, and adolescent psychiatry, and obesity and lifestyle medicine. Even in the early months of the pandemic, Dr. Bell said she heard people joke that “they don’t know if they are working from home or living at work.”
Physicians aren’t the only ones who are overwhelmed. “We’re also hearing stories from our patients – those at risk for partner violence, dealing with kids out of school, working full time while providing support at home,” Ludmila De Faria, MD, chair of the American Psychiatric Association’s Committee on Women’s Mental Health, said in an interview.
American mothers in particular spend nearly twice as much time caring for their children and cooking than their spouses, said Dr. Bell, citing recent studies. “Even if one is not a mom, if you couple the increased housework at baseline with the added responsibilities of working as a front-line physician and/or working from home while managing a household, it can lead to increased stress for all involved.”
Women leaving the workforce
Nationally, a growing number of women are either reducing their hours or leaving the workforce in response to the pandemic. Fidelity Investments, which surveyed 1,902 U.S. adults in mid-2020 projected that 4 in 10 women were mulling such options. Among 951 women surveyed, 42% were considering stepping back from their jobs because of their children’s homeschooling needs, and 27% cited difficulties of balancing home and job responsibilities.
Interruptions caused by child care affect women more than men, according to a report from the Century Foundation and the Center for American Progress. “Study after study has shown that, in response to school, child care, and camp closings, as well as reduced hours and reduced class sizes, significantly more women than men have reduced their work hours, left work to care for children, and spent more time on education and household tasks,” the authors noted.
They estimated that the American economy could incur $64.5 billion per year in lost wages and economic activity from the fallout of these trends. In September 2020, four times as many women as men left the workforce, nearly 865,000 women in comparison to 216,000 men.
Many women psychiatrists have been forced to choose between their careers or child care duties – decisions they don’t want to make, but that may be necessary during these unprecedented circumstances. They may be reducing their work hours to assist at home. Others are leaving their jobs, “a terrible situation given the enormous mental health needs of the pandemic” and the fact that so many areas of the United States already suffer from a shortage of clinical psychiatrists, said Dr. Meltzer-Brody.
She has personally seen the effects of this in the large academic department she supervises. “I’m seeing women reducing their work hours or leave positions,” she continued. In addition to child care needs, these women are tending to aging parents affected by COVID-19 or other illnesses, or dealing with the fact that options for elder care aren’t available.
“I have multiple faculty contending with that situation,” added Dr. Meltzer-Brody. As a result, productivity is going down. “These women are trying to keep all of the balls in the air but find they can’t.”
Dr. Richards believes some changes are in order to take the disproportionate burden off of women in psychiatry, and the workforce as a whole. The health care system “places too much pressure on individuals to compensate for its deficiencies. Those individuals who often step up to the plate are women, and this is not their sole burden to carry.”
A move toward telehealth in clinical psychiatry has made it possible for patients and physicians to meet virtually in their respective homes and discuss treatment options. “Even while this is both a blessing and privilege, it comes with the unique challenges of having to manage Zoom calls, child care, meals, distance learning, cleaning, and work responsibilities, while previously there was a clearer delineation to the day for many,” Dr. Bell said.
Clinical psychiatrists educating the public about the mental stressors of COVID-19 face their own unique challenges.
Dr. Lakshmin, who makes appearances in various media and social media outlets, said this adds more pressure to the job. “One of the challenges for me is to figure out how much outward facing I do. That’s hard when you’re navigating working and living through a pandemic. This is something I do because I enjoy doing it. But it’s still a type of work. And it’s certainly increased because the media has been paying more attention to mental health” since the pandemic started, she added.
The dual stress of COVID and social justice
Some women psychiatrists of color are dealing with social justice issues on top of other COVID stressors, Dr. De Faria said. The focus on addressing institutionalized racism means that minority women are taking on extra work to advocate for their peers.
Michelle Jacobs-Elliott, MD, of the department of psychiatry and assistant dean of the Office of Diversity and Health Equity at the University of Florida, Gainesville, knows of such responsibilities. “I have been in many discussions either with my coworkers in my department or others who work for the University of Florida” on systemic racism, she said in an interview.
Dr. Jacobs-Elliott became a trainer for Bias Reduction in Internal Medicine, a workshop aimed at reducing bias, and prior to 2020 participated in a social justice summit at the University of Florida. “Talking with my medical as well as undergraduate students about their experiences both here in Gainesville and elsewhere, they are all feeling the hurt, disappointment, and disbelief that we are still fighting battles that our grandparents fought in health care, housing, and employment. This adds an extra layer of stress to everyone’s life.”
The tense social climate has made the apparent racial inequalities in COVID-19 deaths and severity of disease hard to ignore, Dr. Bell noted. “It is my sincere hope that the availability of COVID-19 vaccines will help decrease the number of people affected by this horrible disease. The added burden of racism on top of the stressors of this pandemic can feel insurmountable. I hope 2021 will provide a way forward for us all.”
Taking time for self-care
Amid the endless referrals and increasing demands at home, women psychiatrists often don’t have the time to do normal activities, Dr. Meltzer-Brody observed. Like most people, COVID restrictions prevent them from traveling or going to the gym or restaurants. Dr. De Faria has not been able to visit family in Latin America, a trip she used to make twice a year. “That was once my de-stress time. But now, I can’t connect with my roots. My father is elderly and very much at risk.”
This is the time to get creative and resourceful – to make time for self-care, several sources said.
“We need to realize that we cannot be all things to all people, at the same time,” noted Dr. Bell. It’s important to prioritize what’s most important – and keep assessing your priorities. There’s no shame in tending to your own needs. Dr. Bell recommended that women in her profession should pick 1 day a week, put it in their calendar, and stick to this goal of self-care.
“Even if it’s only 15 minutes, it is important to put time aside. Some quick, cheap ideas are to do a quick meditation session, read a chapter in a book, listen to an audiobook, journal, go for a walk and get fresh air. Eat a healthy meal. Even 10 minutes helps,” she urged.
COVID-19 has pushed society to find new ways to do things, Dr. Bell continued. Women psychiatrists, in assessing their work-life balance, may need to reassess their goals. Consider work schedules and see if there’s a place to scale back a task. Delegate tasks at home to family members, if necessary. Most importantly, exercise self-compassion, she stressed. “During this pandemic, I believe it is vital to keep our cups filled so we can pour into others.”
Dr. Lakshmin said she has benefited greatly from having a therapist during the pandemic. “It has been so instrumental in forcing me to take that time for myself, to give me a space to take care of me, and remember it’s okay to take care of me. It’s so important for us as psychiatrists to have that for ourselves. It’s not just for our patients – we need it, too.”
The APA has resources and numerous support groups that meet regularly to address and discuss the stressors of the pandemic. Its College Mental Health Caucus, for example, holds a monthly, hour-long Zoom meeting. Not surprisingly, women comprise the majority of attendees, Dr. De Faria said. “Most women in academic psychiatry are working from home and using telehealth, which isolates people a lot.” Maureen Sayres Van Niel, MD, who is head of the APA’s Women’s Caucus, sends out a regular newsletter that advises on self-care. Women psychiatrists should also contact their local psychiatric organizations to get support from their professional peers.
Sometimes it’s wise to leave work behind and engage with friends. Dr. De Faria regularly Zooms with a group of friends outside of her profession to de-stress and reconnect. “At least I can talk to them about things other than psychiatry.”
Mentally and physically exhausted, Dr. Jacobs-Elliott said she looks forward to the day when society can return to meeting with friends and family “without being afraid that we are an asymptomatic carrier who is infecting our loved ones.”
Daily life is now a juggling act for Misty Richards, MD, MS. As the program director of a rigorous child psychiatry fellowship, a psychiatrist caring for women with perinatal psychiatric disorders, and the mother of three young children, Dr. Richards tries to view these tasks as an opportunity for growth. But some days it feels as if she’s navigating a storm in the middle of the ocean without a life jacket.
In the age of COVID, “the wave of demands has morphed into one giant tidal wave of desperate need,” Dr. Richards, of the department of psychiatry & biobehavioral sciences, University of California, Los Angeles, Semel Institute of Neuroscience & Human Behavior, said in an interview. “The painfully loud and clear message is that our patients need us, and our children – who have been stripped from healthy routines and peer interactions that nourish social-emotional development – rely on us. We cannot turn our backs for even a moment, or else they will suffer.”
Tasked with caring for a much sicker and distressed population, navigating home duties such as child care, online school, and taking care of certain family members, women psychiatrists are feeling the impact of COVID-19.
Many have seamlessly transferred their practices online, maintaining a lifeline with their patients through telehealth visits. Even with this convenience, the emotional labor of being a psychiatrist is still very stressful, Pooja Lakshmin, MD, of the department of psychiatry and behavioral sciences at George Washington University, Washington, said in an interview. Because the nature of work has changed, and many are doing things virtually at home, separating home from work life can be a challenge. “It’s harder to disconnect,” admitted Dr. Lakshmin. “Even my patients tell me that they have no time to themselves anymore.”
– a moving target that remains nowhere in sight, Dr. Richards said. “In this process, we are expected to fill the emotional cups of a broken nation, to provide answers that do not exist, and to do so with never-ending gratitude for a demanding system that has no ‘off’ switch,” she noted.
‘In two places at once’
COVID-19’s physical and emotional toll has swept across the various subspecialties of clinical psychiatry. As some navigate outpatient/telehealth work, inpatient psychiatrists directly interact with COVID patients.
“Our inpatient psychiatry unit regularly takes care of COVID patients, including perinatal patients who are COVID positive,” Samantha Meltzer-Brody, MD, MPH, distinguished professor and chair, University of North Carolina, Chapel Hill, department of psychiatry and director of medical school’s Center for Women’s Mood Disorders, said in an interview. A psychiatry consultation-liaison service also provides psychiatry care to medical and surgical patients, including medically ill COVID patients across the hospital.
“We are on the front lines in the sense that we are dealing with the trauma of the general population and having to be present for that emotional distress,” Dr. Meltzer-Brody said.
The struggle to balance rising caseloads and home responsibilities makes things difficult, she continued. “There’s a never-ending onslaught of patient referrals,” reflecting the anxiety and depression issues people are experiencing in the wake of a global pandemic, frenetic political situation in the United States, and job uncertainty.
Child care and elder care responsibilities affect both men and women, yet research shows that caregiving demands disproportionately affect women, observed Dr. Meltzer-Brody.
Overall, the stress of caregiving and parenting responsibilities for men and women has been markedly higher during the pandemic. Most clinical psychiatrists “have been extraordinarily busy for a very long time,” she added.
Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., has seen an increase in anxiety and depression in people with no previous history of diagnosed mental illness. “The impact of the pandemic has truly been multifaceted. People are struggling with loss of jobs, loss of wages, and loss of loved ones, along with grieving the loss of the usual way of life,” she said in an interview.
Many of her colleagues report feeling overburdened at work with increased admissions and patient loads, decreased time to see each patient, and the feeling of “needing to be in two places at once.”
“As a female psychiatrist, I do believe that we can sometimes have an increased mental burden due to the emotional and physical burnout that can occur when our routines are shaken,” added Dr. Bell, who specializes in adult, child, and adolescent psychiatry, and obesity and lifestyle medicine. Even in the early months of the pandemic, Dr. Bell said she heard people joke that “they don’t know if they are working from home or living at work.”
Physicians aren’t the only ones who are overwhelmed. “We’re also hearing stories from our patients – those at risk for partner violence, dealing with kids out of school, working full time while providing support at home,” Ludmila De Faria, MD, chair of the American Psychiatric Association’s Committee on Women’s Mental Health, said in an interview.
American mothers in particular spend nearly twice as much time caring for their children and cooking than their spouses, said Dr. Bell, citing recent studies. “Even if one is not a mom, if you couple the increased housework at baseline with the added responsibilities of working as a front-line physician and/or working from home while managing a household, it can lead to increased stress for all involved.”
Women leaving the workforce
Nationally, a growing number of women are either reducing their hours or leaving the workforce in response to the pandemic. Fidelity Investments, which surveyed 1,902 U.S. adults in mid-2020 projected that 4 in 10 women were mulling such options. Among 951 women surveyed, 42% were considering stepping back from their jobs because of their children’s homeschooling needs, and 27% cited difficulties of balancing home and job responsibilities.
Interruptions caused by child care affect women more than men, according to a report from the Century Foundation and the Center for American Progress. “Study after study has shown that, in response to school, child care, and camp closings, as well as reduced hours and reduced class sizes, significantly more women than men have reduced their work hours, left work to care for children, and spent more time on education and household tasks,” the authors noted.
They estimated that the American economy could incur $64.5 billion per year in lost wages and economic activity from the fallout of these trends. In September 2020, four times as many women as men left the workforce, nearly 865,000 women in comparison to 216,000 men.
Many women psychiatrists have been forced to choose between their careers or child care duties – decisions they don’t want to make, but that may be necessary during these unprecedented circumstances. They may be reducing their work hours to assist at home. Others are leaving their jobs, “a terrible situation given the enormous mental health needs of the pandemic” and the fact that so many areas of the United States already suffer from a shortage of clinical psychiatrists, said Dr. Meltzer-Brody.
She has personally seen the effects of this in the large academic department she supervises. “I’m seeing women reducing their work hours or leave positions,” she continued. In addition to child care needs, these women are tending to aging parents affected by COVID-19 or other illnesses, or dealing with the fact that options for elder care aren’t available.
“I have multiple faculty contending with that situation,” added Dr. Meltzer-Brody. As a result, productivity is going down. “These women are trying to keep all of the balls in the air but find they can’t.”
Dr. Richards believes some changes are in order to take the disproportionate burden off of women in psychiatry, and the workforce as a whole. The health care system “places too much pressure on individuals to compensate for its deficiencies. Those individuals who often step up to the plate are women, and this is not their sole burden to carry.”
A move toward telehealth in clinical psychiatry has made it possible for patients and physicians to meet virtually in their respective homes and discuss treatment options. “Even while this is both a blessing and privilege, it comes with the unique challenges of having to manage Zoom calls, child care, meals, distance learning, cleaning, and work responsibilities, while previously there was a clearer delineation to the day for many,” Dr. Bell said.
Clinical psychiatrists educating the public about the mental stressors of COVID-19 face their own unique challenges.
Dr. Lakshmin, who makes appearances in various media and social media outlets, said this adds more pressure to the job. “One of the challenges for me is to figure out how much outward facing I do. That’s hard when you’re navigating working and living through a pandemic. This is something I do because I enjoy doing it. But it’s still a type of work. And it’s certainly increased because the media has been paying more attention to mental health” since the pandemic started, she added.
The dual stress of COVID and social justice
Some women psychiatrists of color are dealing with social justice issues on top of other COVID stressors, Dr. De Faria said. The focus on addressing institutionalized racism means that minority women are taking on extra work to advocate for their peers.
Michelle Jacobs-Elliott, MD, of the department of psychiatry and assistant dean of the Office of Diversity and Health Equity at the University of Florida, Gainesville, knows of such responsibilities. “I have been in many discussions either with my coworkers in my department or others who work for the University of Florida” on systemic racism, she said in an interview.
Dr. Jacobs-Elliott became a trainer for Bias Reduction in Internal Medicine, a workshop aimed at reducing bias, and prior to 2020 participated in a social justice summit at the University of Florida. “Talking with my medical as well as undergraduate students about their experiences both here in Gainesville and elsewhere, they are all feeling the hurt, disappointment, and disbelief that we are still fighting battles that our grandparents fought in health care, housing, and employment. This adds an extra layer of stress to everyone’s life.”
The tense social climate has made the apparent racial inequalities in COVID-19 deaths and severity of disease hard to ignore, Dr. Bell noted. “It is my sincere hope that the availability of COVID-19 vaccines will help decrease the number of people affected by this horrible disease. The added burden of racism on top of the stressors of this pandemic can feel insurmountable. I hope 2021 will provide a way forward for us all.”
Taking time for self-care
Amid the endless referrals and increasing demands at home, women psychiatrists often don’t have the time to do normal activities, Dr. Meltzer-Brody observed. Like most people, COVID restrictions prevent them from traveling or going to the gym or restaurants. Dr. De Faria has not been able to visit family in Latin America, a trip she used to make twice a year. “That was once my de-stress time. But now, I can’t connect with my roots. My father is elderly and very much at risk.”
This is the time to get creative and resourceful – to make time for self-care, several sources said.
“We need to realize that we cannot be all things to all people, at the same time,” noted Dr. Bell. It’s important to prioritize what’s most important – and keep assessing your priorities. There’s no shame in tending to your own needs. Dr. Bell recommended that women in her profession should pick 1 day a week, put it in their calendar, and stick to this goal of self-care.
“Even if it’s only 15 minutes, it is important to put time aside. Some quick, cheap ideas are to do a quick meditation session, read a chapter in a book, listen to an audiobook, journal, go for a walk and get fresh air. Eat a healthy meal. Even 10 minutes helps,” she urged.
COVID-19 has pushed society to find new ways to do things, Dr. Bell continued. Women psychiatrists, in assessing their work-life balance, may need to reassess their goals. Consider work schedules and see if there’s a place to scale back a task. Delegate tasks at home to family members, if necessary. Most importantly, exercise self-compassion, she stressed. “During this pandemic, I believe it is vital to keep our cups filled so we can pour into others.”
Dr. Lakshmin said she has benefited greatly from having a therapist during the pandemic. “It has been so instrumental in forcing me to take that time for myself, to give me a space to take care of me, and remember it’s okay to take care of me. It’s so important for us as psychiatrists to have that for ourselves. It’s not just for our patients – we need it, too.”
The APA has resources and numerous support groups that meet regularly to address and discuss the stressors of the pandemic. Its College Mental Health Caucus, for example, holds a monthly, hour-long Zoom meeting. Not surprisingly, women comprise the majority of attendees, Dr. De Faria said. “Most women in academic psychiatry are working from home and using telehealth, which isolates people a lot.” Maureen Sayres Van Niel, MD, who is head of the APA’s Women’s Caucus, sends out a regular newsletter that advises on self-care. Women psychiatrists should also contact their local psychiatric organizations to get support from their professional peers.
Sometimes it’s wise to leave work behind and engage with friends. Dr. De Faria regularly Zooms with a group of friends outside of her profession to de-stress and reconnect. “At least I can talk to them about things other than psychiatry.”
Mentally and physically exhausted, Dr. Jacobs-Elliott said she looks forward to the day when society can return to meeting with friends and family “without being afraid that we are an asymptomatic carrier who is infecting our loved ones.”
COVID-19 in children: Latest weekly increase is largest yet
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.
The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.
The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.
Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.
The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.
The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.
Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.
according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
There were 211,466 new cases reported in children during the week of Jan. 8-14, topping the previous high (Dec. 11-17) by almost 30,000. Those new cases bring the total for the pandemic to over 2.5 million children infected with the coronavirus, which represents 12.6% of all reported cases, the AAP and the CHA said Jan. 19 in their weekly COVID-19 report.
The rise in cases also brought an increase in the proportion reported among children. The week before (Jan. 1-7), cases in children were 12.9% of all cases reported, but the most recent week saw that number rise to 14.5% of all cases, the highest it’s been since early October, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rio, and Guam.
The corresponding figures for severe illness continue to be low: Children represent 1.8% of all hospitalizations from COVID-19 in 24 states and New York City and 0.06% of all deaths in 43 states and New York City. Three deaths were reported for the week of Jan. 8-14, making for a total of 191 since the pandemic started, the AAP and CHA said in their report.
Among the states, California has the most overall cases at just over 350,000, Wyoming has the highest proportion of cases in children (20.3%), and North Dakota has the highest rate of infection (over 8,100 per 100,000 children). The infection rate for the nation is now above 3,300 per 100,000 children, and 11 states reported rates over 5,000, according to the AAP and the CHA.
HHS will drop buprenorphine waiver rule for most physicians
Federal officials on Thursday announced a plan to largely drop the so-called X-waiver requirement for buprenorphine prescriptions for physicians in a bid to remove an administrative procedure widely seen as a barrier to opioid use disorder (OUD) treatment.
The Department of Health & Human Services unveiled new practice guidelines that include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.
A restriction included in the new HHS policy is a limit of treating no more than 30 patients with buprenorphine for OUD at any one time. There is an exception to this limit for hospital-based physicians, such as those working in emergency departments, HHS said.
, such as buprenorphine, and does not apply to methadone. The new guidelines say the date on which they will take effect will be added after publication in the Federal Register. HHS did not immediately answer a request from this news organization for a more specific timeline.
Welcomed change
The change in prescribing rule was widely welcomed, with the American Medical Association issuing a statement endorsing the revision. The AMA and many prescribers and researchers had seen the X-waiver as a hurdle to address the nation’s opioid epidemic.
There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, HHS said in a press release, which cited data from the Centers for Disease Control and Prevention.
In a tweet about the new policy, Peter Grinspoon, MD, a Boston internist and author of the memoir “Free Refills: A Doctor Confronts His Addiction,” contrasted the relative ease with which clinicians can give medicines that carry a risk for abuse with the challenge that has existed in trying to provide patients with buprenorphine.
“Absolutely insane that we need a special waiver for buprenorphine to TREAT opioid addiction, but not to prescribe oxycodone, Vicodin, etc., which can get people in trouble in the first place!!” Dr. Grinspoon tweeted.
Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said removing the X-waiver requirement can help lessen the stigma associated with this OUD treatment. The AMA had urged HHS to change the regulation.
“With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime,” Dr. Harris said in the AMA statement.
Researchers have in recent years sought to highlight what they described as missed opportunities for OUD treatment because of the need for the X-waiver.
Buprenorphine is a cost-effective treatment for opioid use disorder, which reduces the risk of injection-related infections and mortality risk, notes a study published online last month in JAMA Network Open.
However, results showed that fewer than 2% of obstetrician-gynecologists who examined women enrolled in Medicaid were trained to prescribe buprenorphine. The study, which was based on data from 31, 211 ob.gyns. who accepted Medicaid insurance, was created to quantify how many were on the list of Drug Addiction Treatment Act buprenorphine-waived clinicians.
The Drug Addiction Treatment Act has required 8 hours of training for physicians and 24 hours for nurse practitioners and physician assistants for the X-waiver needed to prescribe buprenorphine, the investigators report.
‘X the X-waiver’
Only 10% of recent family residency graduates reported being adequately trained to prescribe buprenorphine and only 7% reported actually prescribing the drug, write Kevin Fiscella, MD, University of Rochester (N.Y.) Medical Center and colleagues in a 2018 Viewpoint article published in JAMA Psychiatry.
In the article, which was subtitled “X the X Waiver,” they called for deregulation of buprenorphine as a way of mainstreaming treatment for OUD.
“The DATA 2000 has failed – too few physicians have obtained X-waivers,” the authors write. “Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”
The change, announced Jan. 14, leaves in place restrictions on prescribing for clinicians other than physicians. On a call with reporters, Adm. Brett P. Giroir, MD, assistant secretary for health, suggested that federal officials should take further steps to remove hurdles to buprenorphine prescriptions.
“Many people will say this has gone too far,” Dr. Giroir said of the drive to end the X-waiver for clinicians. “But I believe more people will say this has not gone far enough.”
A version of this article first appeared on Medscape.com.
Federal officials on Thursday announced a plan to largely drop the so-called X-waiver requirement for buprenorphine prescriptions for physicians in a bid to remove an administrative procedure widely seen as a barrier to opioid use disorder (OUD) treatment.
The Department of Health & Human Services unveiled new practice guidelines that include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.
A restriction included in the new HHS policy is a limit of treating no more than 30 patients with buprenorphine for OUD at any one time. There is an exception to this limit for hospital-based physicians, such as those working in emergency departments, HHS said.
, such as buprenorphine, and does not apply to methadone. The new guidelines say the date on which they will take effect will be added after publication in the Federal Register. HHS did not immediately answer a request from this news organization for a more specific timeline.
Welcomed change
The change in prescribing rule was widely welcomed, with the American Medical Association issuing a statement endorsing the revision. The AMA and many prescribers and researchers had seen the X-waiver as a hurdle to address the nation’s opioid epidemic.
There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, HHS said in a press release, which cited data from the Centers for Disease Control and Prevention.
In a tweet about the new policy, Peter Grinspoon, MD, a Boston internist and author of the memoir “Free Refills: A Doctor Confronts His Addiction,” contrasted the relative ease with which clinicians can give medicines that carry a risk for abuse with the challenge that has existed in trying to provide patients with buprenorphine.
“Absolutely insane that we need a special waiver for buprenorphine to TREAT opioid addiction, but not to prescribe oxycodone, Vicodin, etc., which can get people in trouble in the first place!!” Dr. Grinspoon tweeted.
Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said removing the X-waiver requirement can help lessen the stigma associated with this OUD treatment. The AMA had urged HHS to change the regulation.
“With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime,” Dr. Harris said in the AMA statement.
Researchers have in recent years sought to highlight what they described as missed opportunities for OUD treatment because of the need for the X-waiver.
Buprenorphine is a cost-effective treatment for opioid use disorder, which reduces the risk of injection-related infections and mortality risk, notes a study published online last month in JAMA Network Open.
However, results showed that fewer than 2% of obstetrician-gynecologists who examined women enrolled in Medicaid were trained to prescribe buprenorphine. The study, which was based on data from 31, 211 ob.gyns. who accepted Medicaid insurance, was created to quantify how many were on the list of Drug Addiction Treatment Act buprenorphine-waived clinicians.
The Drug Addiction Treatment Act has required 8 hours of training for physicians and 24 hours for nurse practitioners and physician assistants for the X-waiver needed to prescribe buprenorphine, the investigators report.
‘X the X-waiver’
Only 10% of recent family residency graduates reported being adequately trained to prescribe buprenorphine and only 7% reported actually prescribing the drug, write Kevin Fiscella, MD, University of Rochester (N.Y.) Medical Center and colleagues in a 2018 Viewpoint article published in JAMA Psychiatry.
In the article, which was subtitled “X the X Waiver,” they called for deregulation of buprenorphine as a way of mainstreaming treatment for OUD.
“The DATA 2000 has failed – too few physicians have obtained X-waivers,” the authors write. “Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”
The change, announced Jan. 14, leaves in place restrictions on prescribing for clinicians other than physicians. On a call with reporters, Adm. Brett P. Giroir, MD, assistant secretary for health, suggested that federal officials should take further steps to remove hurdles to buprenorphine prescriptions.
“Many people will say this has gone too far,” Dr. Giroir said of the drive to end the X-waiver for clinicians. “But I believe more people will say this has not gone far enough.”
A version of this article first appeared on Medscape.com.
Federal officials on Thursday announced a plan to largely drop the so-called X-waiver requirement for buprenorphine prescriptions for physicians in a bid to remove an administrative procedure widely seen as a barrier to opioid use disorder (OUD) treatment.
The Department of Health & Human Services unveiled new practice guidelines that include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.
A restriction included in the new HHS policy is a limit of treating no more than 30 patients with buprenorphine for OUD at any one time. There is an exception to this limit for hospital-based physicians, such as those working in emergency departments, HHS said.
, such as buprenorphine, and does not apply to methadone. The new guidelines say the date on which they will take effect will be added after publication in the Federal Register. HHS did not immediately answer a request from this news organization for a more specific timeline.
Welcomed change
The change in prescribing rule was widely welcomed, with the American Medical Association issuing a statement endorsing the revision. The AMA and many prescribers and researchers had seen the X-waiver as a hurdle to address the nation’s opioid epidemic.
There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, HHS said in a press release, which cited data from the Centers for Disease Control and Prevention.
In a tweet about the new policy, Peter Grinspoon, MD, a Boston internist and author of the memoir “Free Refills: A Doctor Confronts His Addiction,” contrasted the relative ease with which clinicians can give medicines that carry a risk for abuse with the challenge that has existed in trying to provide patients with buprenorphine.
“Absolutely insane that we need a special waiver for buprenorphine to TREAT opioid addiction, but not to prescribe oxycodone, Vicodin, etc., which can get people in trouble in the first place!!” Dr. Grinspoon tweeted.
Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said removing the X-waiver requirement can help lessen the stigma associated with this OUD treatment. The AMA had urged HHS to change the regulation.
“With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime,” Dr. Harris said in the AMA statement.
Researchers have in recent years sought to highlight what they described as missed opportunities for OUD treatment because of the need for the X-waiver.
Buprenorphine is a cost-effective treatment for opioid use disorder, which reduces the risk of injection-related infections and mortality risk, notes a study published online last month in JAMA Network Open.
However, results showed that fewer than 2% of obstetrician-gynecologists who examined women enrolled in Medicaid were trained to prescribe buprenorphine. The study, which was based on data from 31, 211 ob.gyns. who accepted Medicaid insurance, was created to quantify how many were on the list of Drug Addiction Treatment Act buprenorphine-waived clinicians.
The Drug Addiction Treatment Act has required 8 hours of training for physicians and 24 hours for nurse practitioners and physician assistants for the X-waiver needed to prescribe buprenorphine, the investigators report.
‘X the X-waiver’
Only 10% of recent family residency graduates reported being adequately trained to prescribe buprenorphine and only 7% reported actually prescribing the drug, write Kevin Fiscella, MD, University of Rochester (N.Y.) Medical Center and colleagues in a 2018 Viewpoint article published in JAMA Psychiatry.
In the article, which was subtitled “X the X Waiver,” they called for deregulation of buprenorphine as a way of mainstreaming treatment for OUD.
“The DATA 2000 has failed – too few physicians have obtained X-waivers,” the authors write. “Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”
The change, announced Jan. 14, leaves in place restrictions on prescribing for clinicians other than physicians. On a call with reporters, Adm. Brett P. Giroir, MD, assistant secretary for health, suggested that federal officials should take further steps to remove hurdles to buprenorphine prescriptions.
“Many people will say this has gone too far,” Dr. Giroir said of the drive to end the X-waiver for clinicians. “But I believe more people will say this has not gone far enough.”
A version of this article first appeared on Medscape.com.