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Cardiology groups push back on hydroxychloroquine, azithromycin for COVID-19
The .
“Hydroxychloroquine and azithromycin have been touted for potential prophylaxis or treatment for COVID-19; both drugs are listed as definite causes of torsade de pointes” and increase in the risk of other arrhythmias and sudden death, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society said in a joint statement April 8 in Circulation.
The statement came amid ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite lack of strong data.
In addition to underlying cardiovascular disease, “seriously ill patients often have comorbidities that can increase risk of serious arrhythmias,” including hypokalemia, hypomagnesemia, fever, and systemic inflammation, the groups said.
They recommended withholding the drugs in patients with baseline QT prolongation (e.g., QTc of at least 500 msec) or with known congenital long QT syndrome; monitoring cardiac rhythm and QT interval and withdrawing hydroxychloroquine and azithromycin if QTc exceeds 500 msec; correcting hypokalemia to levels greater than 4 mEq/L and hypomagnesemia to more than 2 mg/dL; and avoiding other QTc-prolonging agents when possible.
The groups noted that, “in patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so optimal electrocardiographic interval and rhythm monitoring may not be possible.” There is also a possible compounding arrhythmic effect when hydroxychloroquine and azithromycin are used together, but that has not been studied.
There’s a known risk of torsade de pointes with chloroquine and a possible risk with the antiviral HIV combination drug lopinavir-ritonavir, two other candidates for COVID-19 treatment. Hydroxychloroquine and chloroquine, both antimalarials, might help prevent or treat infection by interfering with angiotensin-converting enzyme 2 receptors, which the COVID-19 virus uses for cell entry, the groups said.
“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment. While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease,” Robert A. Harrington, MD, AHA president and chair of the department of medicine at Stanford (Calif.) University, emphasized in a press release.
SOURCE: Roden DM et al. Circulation. 2020 Apr 8. doi:10.1161/CIRCULATIONAHA.120.047521.
The .
“Hydroxychloroquine and azithromycin have been touted for potential prophylaxis or treatment for COVID-19; both drugs are listed as definite causes of torsade de pointes” and increase in the risk of other arrhythmias and sudden death, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society said in a joint statement April 8 in Circulation.
The statement came amid ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite lack of strong data.
In addition to underlying cardiovascular disease, “seriously ill patients often have comorbidities that can increase risk of serious arrhythmias,” including hypokalemia, hypomagnesemia, fever, and systemic inflammation, the groups said.
They recommended withholding the drugs in patients with baseline QT prolongation (e.g., QTc of at least 500 msec) or with known congenital long QT syndrome; monitoring cardiac rhythm and QT interval and withdrawing hydroxychloroquine and azithromycin if QTc exceeds 500 msec; correcting hypokalemia to levels greater than 4 mEq/L and hypomagnesemia to more than 2 mg/dL; and avoiding other QTc-prolonging agents when possible.
The groups noted that, “in patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so optimal electrocardiographic interval and rhythm monitoring may not be possible.” There is also a possible compounding arrhythmic effect when hydroxychloroquine and azithromycin are used together, but that has not been studied.
There’s a known risk of torsade de pointes with chloroquine and a possible risk with the antiviral HIV combination drug lopinavir-ritonavir, two other candidates for COVID-19 treatment. Hydroxychloroquine and chloroquine, both antimalarials, might help prevent or treat infection by interfering with angiotensin-converting enzyme 2 receptors, which the COVID-19 virus uses for cell entry, the groups said.
“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment. While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease,” Robert A. Harrington, MD, AHA president and chair of the department of medicine at Stanford (Calif.) University, emphasized in a press release.
SOURCE: Roden DM et al. Circulation. 2020 Apr 8. doi:10.1161/CIRCULATIONAHA.120.047521.
The .
“Hydroxychloroquine and azithromycin have been touted for potential prophylaxis or treatment for COVID-19; both drugs are listed as definite causes of torsade de pointes” and increase in the risk of other arrhythmias and sudden death, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society said in a joint statement April 8 in Circulation.
The statement came amid ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite lack of strong data.
In addition to underlying cardiovascular disease, “seriously ill patients often have comorbidities that can increase risk of serious arrhythmias,” including hypokalemia, hypomagnesemia, fever, and systemic inflammation, the groups said.
They recommended withholding the drugs in patients with baseline QT prolongation (e.g., QTc of at least 500 msec) or with known congenital long QT syndrome; monitoring cardiac rhythm and QT interval and withdrawing hydroxychloroquine and azithromycin if QTc exceeds 500 msec; correcting hypokalemia to levels greater than 4 mEq/L and hypomagnesemia to more than 2 mg/dL; and avoiding other QTc-prolonging agents when possible.
The groups noted that, “in patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so optimal electrocardiographic interval and rhythm monitoring may not be possible.” There is also a possible compounding arrhythmic effect when hydroxychloroquine and azithromycin are used together, but that has not been studied.
There’s a known risk of torsade de pointes with chloroquine and a possible risk with the antiviral HIV combination drug lopinavir-ritonavir, two other candidates for COVID-19 treatment. Hydroxychloroquine and chloroquine, both antimalarials, might help prevent or treat infection by interfering with angiotensin-converting enzyme 2 receptors, which the COVID-19 virus uses for cell entry, the groups said.
“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment. While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease,” Robert A. Harrington, MD, AHA president and chair of the department of medicine at Stanford (Calif.) University, emphasized in a press release.
SOURCE: Roden DM et al. Circulation. 2020 Apr 8. doi:10.1161/CIRCULATIONAHA.120.047521.
COVID-19: Dramatic changes to telepsychiatry rules and regs
In the wake of the coronavirus pandemic,
Under the 1135 emergency waiver, Medicare has expanded telehealth services to include patients across the country – not just in rural areas or under other limited conditions, as was previously the case. In addition, there’s now a waiver to the Ryan Haight Act that allows the prescribing of controlled substances via telemedicine.
Peter Yellowlees, MD, from University of California, Davis, reported that outpatient service at his center was converted to an almost 100% telepsychiatry service from mid- to late March.
He and John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, led a free webinar late last month sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
During the hour-long event, they answered questions and offered tips on changes in licensure, patient safety, new prescribing rules, and equipment needed.
“Clinicians need to be aware of these changes so they can ensure they are reaching as many people as possible and taking advantage of the reduced barriers to offering safe and effective video visits,” Dr. Torous said in an interview.
‘This is huge’
The new 1135 waiver “basically says CMS will pay for any patient on Medicare who is seen by video by any provider who is correctly licensed in any state in this country,” Dr. Yellowlees told webinar attendees.
“You don’t need to be licensed in the state where the patient is if the patient is on Medicare. This opens up a huge number of patients we can now see on video,” he said. “And you can bill at normal Medicare rates for whatever you normally get for your in-person patients.”
Although this temporary rule only applies to Medicare and not to private insurers, or to patients on Medicaid, “these are really big changes. This is huge,” Dr. Torous said.
Previously, the “originating site” rule stated that, for the most part, clinicians had to be licensed in the state where the patient was located and not where the physician was stationed.
Asked about college students receiving mental health care who were in school in the psychiatrist’s area but are now back home in a state where the clinician doesn’t have a license, Dr. Yellowlees said that scenario could be a bit “tricky.”
“Most of those patients probably aren’t on Medicare. Legally, you [usually] can’t see them on video if they have private insurance or Medicaid. So, hopefully you can give them a 3-month supply of medication and then recommend they see a local provider,” he said.
Still, all states have their own rules, Dr. Yellowlees said. He and Dr. Torous noted that the Federation of State Medical Boards has a “very up-to-date” listing of policies at FSMB.org, all of which are organized by state. In addition, the American Psychiatric Association provides a telepsychiatry toolkit on its website.
Ryan Haight Act and prescribing
Physicians are now permitted to prescribe medication to patients assessed via telemedicine.
For those with substance use disorders, the U.S. Drug Enforcement Administration has announced a new waiver for the Ryan Haight Online Pharmacy Consumer Protection Act.
The waiver states that “practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances” – as long as it’s for a legitimate medical purpose; real-time, two-way interactive communication with patients has been used; and the clinician “is acting in accordance with applicable Federal and State laws.”
“It’s now possible to prescribe all the normal psychiatric drugs but also benzodiazepines, stimulants, and potentially narcotics over telepsychiatry,” even at a first visit via video, Dr. Yellowlees said.
However, he noted at this point the waiver is current for only 60 days. “This isn’t a permanent condition. It could be extended or even shortened at any given time.”
In addition, SAMHSA has relaxed some of its own regulations regarding telehealth and opioid treatment programs. An FAQ section on the organization’s website provides guidance for providing methadone and buprenorphine treatment.
“Some of the previous regulations will probably be put back in place later on, but the new changes are helpful now,” Dr. Yellowlees said.
Simple equipment needed
Regarding equipment, Dr. Yellowlees noted that the most important component is just a laptop, tablet, or smartphone – for the clinician and for the patient.
“You don’t need fancy new technology with a separate camera or microphone,” he said. However, it might be worth investing in a little better system down the line, he added.
Simple platforms that can be used to meet virtually with patients include FaceTime, Google Hangouts, and Skype.
Although some of these (such as FaceTime) are not HIPAA compliant, “that’s okay for now” under the new rules, Dr. Yellowlees said. While the health system/commercial version of Skype is compliant, the normal consumer-downloaded version is not, he noted.
“I would still strongly suggest using HIPAA-compliant video-conferencing programs in the long run,” he added.
Either way, it’s important for various safety practices to be put into place. For example, clinicians should be careful because the consumer version of Skype can show names of patients who were previously spoken with.
A business associate agreement (BAA) is something that HIPAA-compliant video systems will offer and which should be signed. It’s an agreement that “you’ll be, essentially, looking through a tunnel at the persona at the other end, and the company cannot get inside the tunnel and watch you while you’re having your interview,” said Dr. Yellowlees.
“There are multiple videoconferencing systems around that you can use,” he added. “The three major ones are from Zoom, Vidyo, and VSee, but there are probably 40 or 50 more.”
“There are a lot out there, and we’re certainly not endorsing any one of them,” Dr. Torous added.
When evaluating potential programs, Dr. Yellowlees suggested looking at Yelp-style reviews or telemedicine review sites, or talk with colleagues.
“Basically, you want systems that offer high-definition video quality and the ability to ‘lock’ and ‘unlock’ the rooms. And you want it to have an app so mobile devices can use it,” he said.
Phone vs. video
Some patients, especially older ones, may be resistant to the idea of video chats, preferring to talk via telephone instead.
“If you can use video, it’s better to do that if you can, especially when setting up the systems are relatively simple,” Dr. Yellowlees said, adding that it might just be an issue of patients needing help to get started.
However, “for some people, this is a barrier that we have to respect,” Dr. Torous said.
Either way, clinicians should check the American Medical Association’s website for information about coding for both video and phone visits.
Asked whether a clinician needs written consent from patients for conducting telepsychiatry visits, Dr. Yellowlees said it’s important to check state-by-state rules. For example, California allows a verbal consent.
In many cases, “simply jot down a note that consent was given and how” and write down the address where the patient is located at time of visit, such as for their home, he said.
If a patient wants to conduct a telehealth session while in their car, Dr. Yellowlees suggested getting the address of the parking lot. For safety, clinicians also are advised asking for the cell phone number of the patient as well as that of a loved one.
Vital signs
When it comes to checking vital signs, Dr. Yellowlees suggested asking patients to purchase an inexpensive blood pressure (BP) monitor, thermometer, etc, prior to an appointment.
“Ask them to do a BP test on video and show you the readings. For the AIMS [Abnormal Involuntary Movement Scale] test, or to check for tardive dyskinesia, instruct patients to come close to the camera to show movement.”
In addition, most psychiatric rating scales are available online, which patients can fill out before a telehealth visit. The Serious Mental Illness (SMI) Adviser mobile app also includes several of these scales, Dr. Torous noted.
Overall, “there have been dramatic changes in the rules and regulations governing [telepsychiatry] that, for the next 60 days, make it easier to offer telehealth to patients,” Dr. Torous said.
Therefore, all psychiatrists need to “get on board,” as soon as possible, Dr. Yellowlees added.
The webinar was funded in part by a grant from SAMHSA.
A version of this article originally appeared on Medscape.com.
In the wake of the coronavirus pandemic,
Under the 1135 emergency waiver, Medicare has expanded telehealth services to include patients across the country – not just in rural areas or under other limited conditions, as was previously the case. In addition, there’s now a waiver to the Ryan Haight Act that allows the prescribing of controlled substances via telemedicine.
Peter Yellowlees, MD, from University of California, Davis, reported that outpatient service at his center was converted to an almost 100% telepsychiatry service from mid- to late March.
He and John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, led a free webinar late last month sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
During the hour-long event, they answered questions and offered tips on changes in licensure, patient safety, new prescribing rules, and equipment needed.
“Clinicians need to be aware of these changes so they can ensure they are reaching as many people as possible and taking advantage of the reduced barriers to offering safe and effective video visits,” Dr. Torous said in an interview.
‘This is huge’
The new 1135 waiver “basically says CMS will pay for any patient on Medicare who is seen by video by any provider who is correctly licensed in any state in this country,” Dr. Yellowlees told webinar attendees.
“You don’t need to be licensed in the state where the patient is if the patient is on Medicare. This opens up a huge number of patients we can now see on video,” he said. “And you can bill at normal Medicare rates for whatever you normally get for your in-person patients.”
Although this temporary rule only applies to Medicare and not to private insurers, or to patients on Medicaid, “these are really big changes. This is huge,” Dr. Torous said.
Previously, the “originating site” rule stated that, for the most part, clinicians had to be licensed in the state where the patient was located and not where the physician was stationed.
Asked about college students receiving mental health care who were in school in the psychiatrist’s area but are now back home in a state where the clinician doesn’t have a license, Dr. Yellowlees said that scenario could be a bit “tricky.”
“Most of those patients probably aren’t on Medicare. Legally, you [usually] can’t see them on video if they have private insurance or Medicaid. So, hopefully you can give them a 3-month supply of medication and then recommend they see a local provider,” he said.
Still, all states have their own rules, Dr. Yellowlees said. He and Dr. Torous noted that the Federation of State Medical Boards has a “very up-to-date” listing of policies at FSMB.org, all of which are organized by state. In addition, the American Psychiatric Association provides a telepsychiatry toolkit on its website.
Ryan Haight Act and prescribing
Physicians are now permitted to prescribe medication to patients assessed via telemedicine.
For those with substance use disorders, the U.S. Drug Enforcement Administration has announced a new waiver for the Ryan Haight Online Pharmacy Consumer Protection Act.
The waiver states that “practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances” – as long as it’s for a legitimate medical purpose; real-time, two-way interactive communication with patients has been used; and the clinician “is acting in accordance with applicable Federal and State laws.”
“It’s now possible to prescribe all the normal psychiatric drugs but also benzodiazepines, stimulants, and potentially narcotics over telepsychiatry,” even at a first visit via video, Dr. Yellowlees said.
However, he noted at this point the waiver is current for only 60 days. “This isn’t a permanent condition. It could be extended or even shortened at any given time.”
In addition, SAMHSA has relaxed some of its own regulations regarding telehealth and opioid treatment programs. An FAQ section on the organization’s website provides guidance for providing methadone and buprenorphine treatment.
“Some of the previous regulations will probably be put back in place later on, but the new changes are helpful now,” Dr. Yellowlees said.
Simple equipment needed
Regarding equipment, Dr. Yellowlees noted that the most important component is just a laptop, tablet, or smartphone – for the clinician and for the patient.
“You don’t need fancy new technology with a separate camera or microphone,” he said. However, it might be worth investing in a little better system down the line, he added.
Simple platforms that can be used to meet virtually with patients include FaceTime, Google Hangouts, and Skype.
Although some of these (such as FaceTime) are not HIPAA compliant, “that’s okay for now” under the new rules, Dr. Yellowlees said. While the health system/commercial version of Skype is compliant, the normal consumer-downloaded version is not, he noted.
“I would still strongly suggest using HIPAA-compliant video-conferencing programs in the long run,” he added.
Either way, it’s important for various safety practices to be put into place. For example, clinicians should be careful because the consumer version of Skype can show names of patients who were previously spoken with.
A business associate agreement (BAA) is something that HIPAA-compliant video systems will offer and which should be signed. It’s an agreement that “you’ll be, essentially, looking through a tunnel at the persona at the other end, and the company cannot get inside the tunnel and watch you while you’re having your interview,” said Dr. Yellowlees.
“There are multiple videoconferencing systems around that you can use,” he added. “The three major ones are from Zoom, Vidyo, and VSee, but there are probably 40 or 50 more.”
“There are a lot out there, and we’re certainly not endorsing any one of them,” Dr. Torous added.
When evaluating potential programs, Dr. Yellowlees suggested looking at Yelp-style reviews or telemedicine review sites, or talk with colleagues.
“Basically, you want systems that offer high-definition video quality and the ability to ‘lock’ and ‘unlock’ the rooms. And you want it to have an app so mobile devices can use it,” he said.
Phone vs. video
Some patients, especially older ones, may be resistant to the idea of video chats, preferring to talk via telephone instead.
“If you can use video, it’s better to do that if you can, especially when setting up the systems are relatively simple,” Dr. Yellowlees said, adding that it might just be an issue of patients needing help to get started.
However, “for some people, this is a barrier that we have to respect,” Dr. Torous said.
Either way, clinicians should check the American Medical Association’s website for information about coding for both video and phone visits.
Asked whether a clinician needs written consent from patients for conducting telepsychiatry visits, Dr. Yellowlees said it’s important to check state-by-state rules. For example, California allows a verbal consent.
In many cases, “simply jot down a note that consent was given and how” and write down the address where the patient is located at time of visit, such as for their home, he said.
If a patient wants to conduct a telehealth session while in their car, Dr. Yellowlees suggested getting the address of the parking lot. For safety, clinicians also are advised asking for the cell phone number of the patient as well as that of a loved one.
Vital signs
When it comes to checking vital signs, Dr. Yellowlees suggested asking patients to purchase an inexpensive blood pressure (BP) monitor, thermometer, etc, prior to an appointment.
“Ask them to do a BP test on video and show you the readings. For the AIMS [Abnormal Involuntary Movement Scale] test, or to check for tardive dyskinesia, instruct patients to come close to the camera to show movement.”
In addition, most psychiatric rating scales are available online, which patients can fill out before a telehealth visit. The Serious Mental Illness (SMI) Adviser mobile app also includes several of these scales, Dr. Torous noted.
Overall, “there have been dramatic changes in the rules and regulations governing [telepsychiatry] that, for the next 60 days, make it easier to offer telehealth to patients,” Dr. Torous said.
Therefore, all psychiatrists need to “get on board,” as soon as possible, Dr. Yellowlees added.
The webinar was funded in part by a grant from SAMHSA.
A version of this article originally appeared on Medscape.com.
In the wake of the coronavirus pandemic,
Under the 1135 emergency waiver, Medicare has expanded telehealth services to include patients across the country – not just in rural areas or under other limited conditions, as was previously the case. In addition, there’s now a waiver to the Ryan Haight Act that allows the prescribing of controlled substances via telemedicine.
Peter Yellowlees, MD, from University of California, Davis, reported that outpatient service at his center was converted to an almost 100% telepsychiatry service from mid- to late March.
He and John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, led a free webinar late last month sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
During the hour-long event, they answered questions and offered tips on changes in licensure, patient safety, new prescribing rules, and equipment needed.
“Clinicians need to be aware of these changes so they can ensure they are reaching as many people as possible and taking advantage of the reduced barriers to offering safe and effective video visits,” Dr. Torous said in an interview.
‘This is huge’
The new 1135 waiver “basically says CMS will pay for any patient on Medicare who is seen by video by any provider who is correctly licensed in any state in this country,” Dr. Yellowlees told webinar attendees.
“You don’t need to be licensed in the state where the patient is if the patient is on Medicare. This opens up a huge number of patients we can now see on video,” he said. “And you can bill at normal Medicare rates for whatever you normally get for your in-person patients.”
Although this temporary rule only applies to Medicare and not to private insurers, or to patients on Medicaid, “these are really big changes. This is huge,” Dr. Torous said.
Previously, the “originating site” rule stated that, for the most part, clinicians had to be licensed in the state where the patient was located and not where the physician was stationed.
Asked about college students receiving mental health care who were in school in the psychiatrist’s area but are now back home in a state where the clinician doesn’t have a license, Dr. Yellowlees said that scenario could be a bit “tricky.”
“Most of those patients probably aren’t on Medicare. Legally, you [usually] can’t see them on video if they have private insurance or Medicaid. So, hopefully you can give them a 3-month supply of medication and then recommend they see a local provider,” he said.
Still, all states have their own rules, Dr. Yellowlees said. He and Dr. Torous noted that the Federation of State Medical Boards has a “very up-to-date” listing of policies at FSMB.org, all of which are organized by state. In addition, the American Psychiatric Association provides a telepsychiatry toolkit on its website.
Ryan Haight Act and prescribing
Physicians are now permitted to prescribe medication to patients assessed via telemedicine.
For those with substance use disorders, the U.S. Drug Enforcement Administration has announced a new waiver for the Ryan Haight Online Pharmacy Consumer Protection Act.
The waiver states that “practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances” – as long as it’s for a legitimate medical purpose; real-time, two-way interactive communication with patients has been used; and the clinician “is acting in accordance with applicable Federal and State laws.”
“It’s now possible to prescribe all the normal psychiatric drugs but also benzodiazepines, stimulants, and potentially narcotics over telepsychiatry,” even at a first visit via video, Dr. Yellowlees said.
However, he noted at this point the waiver is current for only 60 days. “This isn’t a permanent condition. It could be extended or even shortened at any given time.”
In addition, SAMHSA has relaxed some of its own regulations regarding telehealth and opioid treatment programs. An FAQ section on the organization’s website provides guidance for providing methadone and buprenorphine treatment.
“Some of the previous regulations will probably be put back in place later on, but the new changes are helpful now,” Dr. Yellowlees said.
Simple equipment needed
Regarding equipment, Dr. Yellowlees noted that the most important component is just a laptop, tablet, or smartphone – for the clinician and for the patient.
“You don’t need fancy new technology with a separate camera or microphone,” he said. However, it might be worth investing in a little better system down the line, he added.
Simple platforms that can be used to meet virtually with patients include FaceTime, Google Hangouts, and Skype.
Although some of these (such as FaceTime) are not HIPAA compliant, “that’s okay for now” under the new rules, Dr. Yellowlees said. While the health system/commercial version of Skype is compliant, the normal consumer-downloaded version is not, he noted.
“I would still strongly suggest using HIPAA-compliant video-conferencing programs in the long run,” he added.
Either way, it’s important for various safety practices to be put into place. For example, clinicians should be careful because the consumer version of Skype can show names of patients who were previously spoken with.
A business associate agreement (BAA) is something that HIPAA-compliant video systems will offer and which should be signed. It’s an agreement that “you’ll be, essentially, looking through a tunnel at the persona at the other end, and the company cannot get inside the tunnel and watch you while you’re having your interview,” said Dr. Yellowlees.
“There are multiple videoconferencing systems around that you can use,” he added. “The three major ones are from Zoom, Vidyo, and VSee, but there are probably 40 or 50 more.”
“There are a lot out there, and we’re certainly not endorsing any one of them,” Dr. Torous added.
When evaluating potential programs, Dr. Yellowlees suggested looking at Yelp-style reviews or telemedicine review sites, or talk with colleagues.
“Basically, you want systems that offer high-definition video quality and the ability to ‘lock’ and ‘unlock’ the rooms. And you want it to have an app so mobile devices can use it,” he said.
Phone vs. video
Some patients, especially older ones, may be resistant to the idea of video chats, preferring to talk via telephone instead.
“If you can use video, it’s better to do that if you can, especially when setting up the systems are relatively simple,” Dr. Yellowlees said, adding that it might just be an issue of patients needing help to get started.
However, “for some people, this is a barrier that we have to respect,” Dr. Torous said.
Either way, clinicians should check the American Medical Association’s website for information about coding for both video and phone visits.
Asked whether a clinician needs written consent from patients for conducting telepsychiatry visits, Dr. Yellowlees said it’s important to check state-by-state rules. For example, California allows a verbal consent.
In many cases, “simply jot down a note that consent was given and how” and write down the address where the patient is located at time of visit, such as for their home, he said.
If a patient wants to conduct a telehealth session while in their car, Dr. Yellowlees suggested getting the address of the parking lot. For safety, clinicians also are advised asking for the cell phone number of the patient as well as that of a loved one.
Vital signs
When it comes to checking vital signs, Dr. Yellowlees suggested asking patients to purchase an inexpensive blood pressure (BP) monitor, thermometer, etc, prior to an appointment.
“Ask them to do a BP test on video and show you the readings. For the AIMS [Abnormal Involuntary Movement Scale] test, or to check for tardive dyskinesia, instruct patients to come close to the camera to show movement.”
In addition, most psychiatric rating scales are available online, which patients can fill out before a telehealth visit. The Serious Mental Illness (SMI) Adviser mobile app also includes several of these scales, Dr. Torous noted.
Overall, “there have been dramatic changes in the rules and regulations governing [telepsychiatry] that, for the next 60 days, make it easier to offer telehealth to patients,” Dr. Torous said.
Therefore, all psychiatrists need to “get on board,” as soon as possible, Dr. Yellowlees added.
The webinar was funded in part by a grant from SAMHSA.
A version of this article originally appeared on Medscape.com.
FDA approves first generic albuterol inhaler
The Food and Drug Administration has approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation, according to a release from the agency. This inhaler is indicated for prevention of bronchospasm in patients aged 4 years and older. Specifically, these are patients with reversible obstructive airway disease or exercise-induced bronchospasm.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD.
The most common side effects include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.
This approval comes as part of FDA’s efforts to guide industry through the development process of generic products, according to the release. Complex combination products – such as this inhaler, which comprises both medication and a delivery system – can be more challenging to develop than solid oral dosage forms, such as tablets.
The FDA released a draft guidance in March 2020 specific to proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. As with other similar guidances, it details the steps companies need to take in developing generics in order to submit complete applications for those products. The full news release regarding this approval is available on the FDA website.
This article was updated 4/8/20.
The Food and Drug Administration has approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation, according to a release from the agency. This inhaler is indicated for prevention of bronchospasm in patients aged 4 years and older. Specifically, these are patients with reversible obstructive airway disease or exercise-induced bronchospasm.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD.
The most common side effects include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.
This approval comes as part of FDA’s efforts to guide industry through the development process of generic products, according to the release. Complex combination products – such as this inhaler, which comprises both medication and a delivery system – can be more challenging to develop than solid oral dosage forms, such as tablets.
The FDA released a draft guidance in March 2020 specific to proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. As with other similar guidances, it details the steps companies need to take in developing generics in order to submit complete applications for those products. The full news release regarding this approval is available on the FDA website.
This article was updated 4/8/20.
The Food and Drug Administration has approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation, according to a release from the agency. This inhaler is indicated for prevention of bronchospasm in patients aged 4 years and older. Specifically, these are patients with reversible obstructive airway disease or exercise-induced bronchospasm.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD.
The most common side effects include upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.
This approval comes as part of FDA’s efforts to guide industry through the development process of generic products, according to the release. Complex combination products – such as this inhaler, which comprises both medication and a delivery system – can be more challenging to develop than solid oral dosage forms, such as tablets.
The FDA released a draft guidance in March 2020 specific to proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. As with other similar guidances, it details the steps companies need to take in developing generics in order to submit complete applications for those products. The full news release regarding this approval is available on the FDA website.
This article was updated 4/8/20.
Comorbidities the rule in New York’s COVID-19 deaths
In New York state, just over 86% of reported COVID-19 deaths involved at least one comorbidity, according to the state’s department of health.
As of midnight on April 6, there had been 5,489 fatalities caused by COVID-19 in the state, of which 86.2% (4,732) had at least one underlying condition, the New York State Department of Health reported April 7 on its COVID-19 tracker.
The leading comorbidity, seen in 55.4% of all deaths, was hypertension. In comparison, a recent estimate from the U.S. Department of Health & Human Services put the prevalence of high blood pressure at about 45% in the overall adult population.
In New York, the rest of the 10 most common comorbidities in COVID-19 fatalities were diabetes (37.3%), hyperlipidemia (18.5%), coronary artery disease (12.4%), renal disease (11.0%), dementia (9.1%), chronic obstructive pulmonary disease (8.3%), cancer (8.1%), atrial fibrillation (7.1%), and heart failure (7.1%), the NYSDOH said.
Other data on the tracker site show that 63% of all deaths involved a patient who was aged 70 years or older and that 61% of COVID-19 patients who have died in New York were male and 38.8% were female (sex unknown for 0.2%). Among all individuals who have tested positive, 54.8% were male and 44.6% were female (sex unknown for 0.6%).
As of the end of day on April 6, a total of 340,058 persons had been tested in the state and 40.8% (138,863) were positive for the SARS-CoV-2 virus. By county, the highest positive rates are in New York City: Queens at 57.4%, Brooklyn at 52.4%, and the Bronx at 52.3%, according to the NYSDOH.
In New York state, just over 86% of reported COVID-19 deaths involved at least one comorbidity, according to the state’s department of health.
As of midnight on April 6, there had been 5,489 fatalities caused by COVID-19 in the state, of which 86.2% (4,732) had at least one underlying condition, the New York State Department of Health reported April 7 on its COVID-19 tracker.
The leading comorbidity, seen in 55.4% of all deaths, was hypertension. In comparison, a recent estimate from the U.S. Department of Health & Human Services put the prevalence of high blood pressure at about 45% in the overall adult population.
In New York, the rest of the 10 most common comorbidities in COVID-19 fatalities were diabetes (37.3%), hyperlipidemia (18.5%), coronary artery disease (12.4%), renal disease (11.0%), dementia (9.1%), chronic obstructive pulmonary disease (8.3%), cancer (8.1%), atrial fibrillation (7.1%), and heart failure (7.1%), the NYSDOH said.
Other data on the tracker site show that 63% of all deaths involved a patient who was aged 70 years or older and that 61% of COVID-19 patients who have died in New York were male and 38.8% were female (sex unknown for 0.2%). Among all individuals who have tested positive, 54.8% were male and 44.6% were female (sex unknown for 0.6%).
As of the end of day on April 6, a total of 340,058 persons had been tested in the state and 40.8% (138,863) were positive for the SARS-CoV-2 virus. By county, the highest positive rates are in New York City: Queens at 57.4%, Brooklyn at 52.4%, and the Bronx at 52.3%, according to the NYSDOH.
In New York state, just over 86% of reported COVID-19 deaths involved at least one comorbidity, according to the state’s department of health.
As of midnight on April 6, there had been 5,489 fatalities caused by COVID-19 in the state, of which 86.2% (4,732) had at least one underlying condition, the New York State Department of Health reported April 7 on its COVID-19 tracker.
The leading comorbidity, seen in 55.4% of all deaths, was hypertension. In comparison, a recent estimate from the U.S. Department of Health & Human Services put the prevalence of high blood pressure at about 45% in the overall adult population.
In New York, the rest of the 10 most common comorbidities in COVID-19 fatalities were diabetes (37.3%), hyperlipidemia (18.5%), coronary artery disease (12.4%), renal disease (11.0%), dementia (9.1%), chronic obstructive pulmonary disease (8.3%), cancer (8.1%), atrial fibrillation (7.1%), and heart failure (7.1%), the NYSDOH said.
Other data on the tracker site show that 63% of all deaths involved a patient who was aged 70 years or older and that 61% of COVID-19 patients who have died in New York were male and 38.8% were female (sex unknown for 0.2%). Among all individuals who have tested positive, 54.8% were male and 44.6% were female (sex unknown for 0.6%).
As of the end of day on April 6, a total of 340,058 persons had been tested in the state and 40.8% (138,863) were positive for the SARS-CoV-2 virus. By county, the highest positive rates are in New York City: Queens at 57.4%, Brooklyn at 52.4%, and the Bronx at 52.3%, according to the NYSDOH.
SARS-CoV-2 escapes cotton, surgical masks of infected
June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here.
according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.
The report was published in Annals of Internal Medicine.
Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.
To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.
The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.
The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.
“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.
The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.
SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.
Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.
June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here.
according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.
The report was published in Annals of Internal Medicine.
Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.
To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.
The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.
The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.
“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.
The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.
SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.
Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.
June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here.
according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.
The report was published in Annals of Internal Medicine.
Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.
To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.
The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.
The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.
“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.
The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.
SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.
Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.
FROM ANNALS OF INTERNAL MEDICINE
AMA president calls for greater reliance on science in COVID-19 fight
The president of the American Medical Association is calling on politicians and the media to rely on science and evidence to help the public through the COVID-19 pandemic.
“We live in a time when misinformation, falsehoods, and outright lies spread like viruses online, through social media and even, at times, in the media at large,” Patrice A. Harris, MD, said during an April 7 address. “We have witnessed a concerning shift over the last several decades where policy decisions seem to be driven by ideology and politics instead of facts and evidence. The result is a growing mistrust in American institutions, in science, and in the counsel of leading experts whose lives are dedicated to the pursuit of evidence and reason.”
To that end, she called on everyone – from politicians to the general public – to trust the scientific evidence.
Dr. Harris noted that the scientific data on COVID-19 have already yielded important lessons about who is more likely to be affected and how easily the virus can spread. The data also point to the effectiveness of stay-at-home and shelter-in-place orders. “This is our best chance to slow the spread of the virus,” she said, adding that the enhanced emphasis on hand washing and other hygiene practices “may seem ‘simplistic,’ but they are, in fact, based in science and evidence.”
And, as the pandemic continues, Dr. Harris said that now is the time to rely on science. She said the AMA “calls on all elected officials to affirm science, evidence, and fact in their words and actions,” and she urged that the government’s scientific institutions be led by experts who are “protected from political influence.”
It is incumbent upon everyone to actively work to contain and stop the spread of misinformation related to COVID-19, she said. “We must ensure the war is against the virus and not against science,” Dr. Harris said.
The president of the American Medical Association is calling on politicians and the media to rely on science and evidence to help the public through the COVID-19 pandemic.
“We live in a time when misinformation, falsehoods, and outright lies spread like viruses online, through social media and even, at times, in the media at large,” Patrice A. Harris, MD, said during an April 7 address. “We have witnessed a concerning shift over the last several decades where policy decisions seem to be driven by ideology and politics instead of facts and evidence. The result is a growing mistrust in American institutions, in science, and in the counsel of leading experts whose lives are dedicated to the pursuit of evidence and reason.”
To that end, she called on everyone – from politicians to the general public – to trust the scientific evidence.
Dr. Harris noted that the scientific data on COVID-19 have already yielded important lessons about who is more likely to be affected and how easily the virus can spread. The data also point to the effectiveness of stay-at-home and shelter-in-place orders. “This is our best chance to slow the spread of the virus,” she said, adding that the enhanced emphasis on hand washing and other hygiene practices “may seem ‘simplistic,’ but they are, in fact, based in science and evidence.”
And, as the pandemic continues, Dr. Harris said that now is the time to rely on science. She said the AMA “calls on all elected officials to affirm science, evidence, and fact in their words and actions,” and she urged that the government’s scientific institutions be led by experts who are “protected from political influence.”
It is incumbent upon everyone to actively work to contain and stop the spread of misinformation related to COVID-19, she said. “We must ensure the war is against the virus and not against science,” Dr. Harris said.
The president of the American Medical Association is calling on politicians and the media to rely on science and evidence to help the public through the COVID-19 pandemic.
“We live in a time when misinformation, falsehoods, and outright lies spread like viruses online, through social media and even, at times, in the media at large,” Patrice A. Harris, MD, said during an April 7 address. “We have witnessed a concerning shift over the last several decades where policy decisions seem to be driven by ideology and politics instead of facts and evidence. The result is a growing mistrust in American institutions, in science, and in the counsel of leading experts whose lives are dedicated to the pursuit of evidence and reason.”
To that end, she called on everyone – from politicians to the general public – to trust the scientific evidence.
Dr. Harris noted that the scientific data on COVID-19 have already yielded important lessons about who is more likely to be affected and how easily the virus can spread. The data also point to the effectiveness of stay-at-home and shelter-in-place orders. “This is our best chance to slow the spread of the virus,” she said, adding that the enhanced emphasis on hand washing and other hygiene practices “may seem ‘simplistic,’ but they are, in fact, based in science and evidence.”
And, as the pandemic continues, Dr. Harris said that now is the time to rely on science. She said the AMA “calls on all elected officials to affirm science, evidence, and fact in their words and actions,” and she urged that the government’s scientific institutions be led by experts who are “protected from political influence.”
It is incumbent upon everyone to actively work to contain and stop the spread of misinformation related to COVID-19, she said. “We must ensure the war is against the virus and not against science,” Dr. Harris said.
Nearly 24 tests for the novel coronavirus are available
according to the Infectious Diseases Society of America (IDSA).
“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.
The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
Tests are being approved through an abbreviated process
Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.
The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.
Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.
The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
The time to obtain results varies
The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.
One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”
How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.
Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.
according to the Infectious Diseases Society of America (IDSA).
“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.
The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
Tests are being approved through an abbreviated process
Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.
The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.
Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.
The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
The time to obtain results varies
The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.
One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”
How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.
Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.
according to the Infectious Diseases Society of America (IDSA).
“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.
The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
Tests are being approved through an abbreviated process
Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.
The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.
Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.
The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
The time to obtain results varies
The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.
One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”
How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.
Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.
Cytokine release syndrome in severe COVID-19: Is tocilizumab effective?
A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.
The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.
Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.
A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.
The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.
Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.
“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.
This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.
SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.
A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.
The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.
Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.
A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.
The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.
Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.
“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.
This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.
SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.
A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.
The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.
Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.
A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.
The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.
Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.
“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.
This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.
SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.
FROM THE INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
U.S. hospitals facing severe challenges from COVID-19, HHS report says
Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).
From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.
The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.
The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.
To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.
Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.
The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.
As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”
Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
Supply Shortages
The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.
Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.
Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.
To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.
Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.
Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.
Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.
Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.
Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
What Hospitals Want
As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.
“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.
This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.
Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.
Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:
- Let them reassign licensed professionals within their hospitals and across healthcare networks
- Provide flexibility with respect to licensed professionals practicing across state lines
- Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships
This article first appeared on Medscape.com.
Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).
From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.
The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.
The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.
To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.
Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.
The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.
As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”
Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
Supply Shortages
The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.
Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.
Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.
To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.
Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.
Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.
Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.
Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.
Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
What Hospitals Want
As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.
“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.
This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.
Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.
Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:
- Let them reassign licensed professionals within their hospitals and across healthcare networks
- Provide flexibility with respect to licensed professionals practicing across state lines
- Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships
This article first appeared on Medscape.com.
Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).
From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.
The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.
The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.
To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.
Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.
The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.
As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”
Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
Supply Shortages
The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.
Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.
Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.
To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.
Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.
Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.
Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.
Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.
Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
What Hospitals Want
As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.
“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.
This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.
Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.
Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:
- Let them reassign licensed professionals within their hospitals and across healthcare networks
- Provide flexibility with respect to licensed professionals practicing across state lines
- Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships
This article first appeared on Medscape.com.
Many children with COVID-19 don’t have cough or fever
according to the Centers for Disease and Prevention Control.
Among pediatric patients younger than 18 years in the United States, 73% had at least one of the trio of symptoms, compared with 93% of adults aged 18-64, noted Lucy A. McNamara, PhD, and the CDC’s COVID-19 response team, based on a preliminary analysis of the 149,082 cases reported as of April 2.
By a small margin, fever – present in 58% of pediatric patients – was the most common sign or symptom of COVID-19, compared with cough at 54% and shortness of breath in 13%. In adults, cough (81%) was seen most often, followed by fever (71%) and shortness of breath (43%), the investigators reported in the MMWR.
In both children and adults, headache and myalgia were more common than shortness of breath, as was sore throat in children, the team added.
“These findings are largely consistent with a report on pediatric COVID-19 patients aged <16 years in China, which found that only 41.5% of pediatric patients had fever [and] 48.5% had cough,” they wrote.
The CDC analysis of pediatric patients was limited by its small sample size, with data on signs and symptoms available for only 11% (291) of the 2,572 children known to have COVID-19 as of April 2. The adult population included 10,944 individuals, who represented 9.6% of the 113,985 U.S. patients aged 18-65, the response team said.
“As the number of COVID-19 cases continues to increase in many parts of the United States, it will be important to adapt COVID-19 surveillance strategies to maintain collection of critical case information without overburdening jurisdiction health departments,” they said.
SOURCE: McNamara LA et al. MMWR 2020 Apr 6;69(early release):1-5.
according to the Centers for Disease and Prevention Control.
Among pediatric patients younger than 18 years in the United States, 73% had at least one of the trio of symptoms, compared with 93% of adults aged 18-64, noted Lucy A. McNamara, PhD, and the CDC’s COVID-19 response team, based on a preliminary analysis of the 149,082 cases reported as of April 2.
By a small margin, fever – present in 58% of pediatric patients – was the most common sign or symptom of COVID-19, compared with cough at 54% and shortness of breath in 13%. In adults, cough (81%) was seen most often, followed by fever (71%) and shortness of breath (43%), the investigators reported in the MMWR.
In both children and adults, headache and myalgia were more common than shortness of breath, as was sore throat in children, the team added.
“These findings are largely consistent with a report on pediatric COVID-19 patients aged <16 years in China, which found that only 41.5% of pediatric patients had fever [and] 48.5% had cough,” they wrote.
The CDC analysis of pediatric patients was limited by its small sample size, with data on signs and symptoms available for only 11% (291) of the 2,572 children known to have COVID-19 as of April 2. The adult population included 10,944 individuals, who represented 9.6% of the 113,985 U.S. patients aged 18-65, the response team said.
“As the number of COVID-19 cases continues to increase in many parts of the United States, it will be important to adapt COVID-19 surveillance strategies to maintain collection of critical case information without overburdening jurisdiction health departments,” they said.
SOURCE: McNamara LA et al. MMWR 2020 Apr 6;69(early release):1-5.
according to the Centers for Disease and Prevention Control.
Among pediatric patients younger than 18 years in the United States, 73% had at least one of the trio of symptoms, compared with 93% of adults aged 18-64, noted Lucy A. McNamara, PhD, and the CDC’s COVID-19 response team, based on a preliminary analysis of the 149,082 cases reported as of April 2.
By a small margin, fever – present in 58% of pediatric patients – was the most common sign or symptom of COVID-19, compared with cough at 54% and shortness of breath in 13%. In adults, cough (81%) was seen most often, followed by fever (71%) and shortness of breath (43%), the investigators reported in the MMWR.
In both children and adults, headache and myalgia were more common than shortness of breath, as was sore throat in children, the team added.
“These findings are largely consistent with a report on pediatric COVID-19 patients aged <16 years in China, which found that only 41.5% of pediatric patients had fever [and] 48.5% had cough,” they wrote.
The CDC analysis of pediatric patients was limited by its small sample size, with data on signs and symptoms available for only 11% (291) of the 2,572 children known to have COVID-19 as of April 2. The adult population included 10,944 individuals, who represented 9.6% of the 113,985 U.S. patients aged 18-65, the response team said.
“As the number of COVID-19 cases continues to increase in many parts of the United States, it will be important to adapt COVID-19 surveillance strategies to maintain collection of critical case information without overburdening jurisdiction health departments,” they said.
SOURCE: McNamara LA et al. MMWR 2020 Apr 6;69(early release):1-5.
FROM MMWR