Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.

Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.

“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.

“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.

Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.

Create “Incident Command Structure”

In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.

Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”

Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.

First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.

“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”

Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.

“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.

“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”

Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.

In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.

Outpatient Care

Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.

To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.

One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.

Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.

Treatment Decisions

Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.

Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.

Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.

Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”

Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.

The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.

Inpatient Care

For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.

Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.

In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.

The Future

The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”

Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”

Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.

Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.

“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.

“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.

Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.

Create “Incident Command Structure”

In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.

Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”

Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.

First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.

“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”

Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.

“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.

“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”

Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.

In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.

Outpatient Care

Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.

To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.

One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.

Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.

Treatment Decisions

Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.

Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.

Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.

Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”

Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.

The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.

Inpatient Care

For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.

Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.

In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.

The Future

The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”

Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”

Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.

Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.

“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.

“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.

Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.

Create “Incident Command Structure”

In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.

Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”

Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.

First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.

“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”

Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.

“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.

“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”

Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.

In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.

Outpatient Care

Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.

To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.

One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.

Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.

Treatment Decisions

Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.

Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.

Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.

Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”

Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.

The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.

Inpatient Care

For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.

Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.

In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.

The Future

The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”

Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”

At one large practice in Bergen County, New Jersey, the waiting room is empty — but its patients are still receiving care. As of mid-March, the practice is still operating, thanks to the group’s willingness to adapt its work flow, sometimes radically, to mitigate the threat of the COVID-19 pandemic.

For example, patients now call the receptionist from their vehicles when they arrive, and wait there until receiving a call back telling them the clinician is ready. The practice has also started using telemedicine for the first time, to the extent it can be adopted in a hurry, and some clinicians are working from home on tasks such as medication refills.

Still, the rapidly increasing numbers of COVID-19 cases in the United States raises the possibility that some physician offices will decide or be forced to close temporarily, as occurred in London last month.

Many practices across the country are having to adjust the way they operate, amid daily changes in the pandemic. What should you do to adapt to this new way of operating your practice?

1. Create a task force to manage change

The readiness of medical practices to address the myriad challenges posed by this crisis has so far been a mixed bag, said Owen Dahl, MBA, a Texas-based medical practice management consultant. “Leadership is going to have to assess what’s happening in the community, what’s happening with staff members who may or may not have the disease and may or may not have to self-quarantine,” Dahl said.

The physicians, the administrator, CEO, or managing partner should be involved in decision making as the global crisis unfolds, added Laurie Morgan, MBA, a California-based practice management consultant. And depending on the size of the practice, it may be useful to delegate specific components of this work to various department managers or other individuals in the group.

The team should assess:

• Recommendations and/or mandates from local, state, and federal governments
• Guidance from specialty and state medical societies
• How to triage patients over the phone, virtual visits, or referral to an alternate site of care
• Where to send patients for testing
• The practice’s inventory of personal protective equipment (PPE)
• Review of and possible revision of current infection control policies
• Possible collaborations within the community
• Reimbursement policies for suspected COVID-19 triage, testing, and follow-up treatment — in office or virtually
• Whether some employees’ work (eg, billing, coding) can be done remotely
• Options for paying personnel in the case of a temporary shutdown
• What’s covered and excluded by the group’s business interruption insurance

2. Consider postponing nonessential appointments

What’s more, it’s crucial for practices to form a strategy that does not involve bringing patients into the office, said Javeed Siddiqui, MD, MPH, an infectious disease physician, epidemiologist, and chief medical officer of TeleMed2U. “One thing we really have to recognize in this pandemic is that we don’t want people going and sitting in our waiting room. We don’t want people coming, and not only exposing other patients, but also further exposing staff. Forward triaging is going to be essential in this type of pandemic.”

Reliant Medical Group, with multiple locations in Massachusetts, for example, announced to patients recently that it will postpone appointments for some routine and elective procedures, as determined by the group’s physicians and clinical staff.

“Taking this step will help limit the number of people passing through our facilities, which will help slow the spread of illness [as recommended by the CDC],” noted an email blast to patients.

3. Overcommunicate to patients

With a situation as dynamic and unprecedented as this, constant and clear communication with patients is crucial. “In general, in my experience, practices don’t realize how much communication is necessary,” said Morgan. “In order to be effective and get the word out, you have to be overcommunicating.”

Today’s practices have multiple ways to communicate to keep people informed, including email, text messaging, social media, patient portals, and even local television and radio.

One email or text message to the patient population can help direct them to the appropriate streams of information. Helping direct patients to updated information is critical.

In contrast, having the front desk field multitudes of calls from concerned patients ties up precious resources, according Siddiqui. “Right now, practices are absolutely inundated, patients are waiting on hold, and that creates a great deal of frustration,” he said.

“We really need to take a page from every other industry in the United States, and that is using secure SMS, email communication, and telehealth,” Siddiqui said. “Healthcare generally tends to be a laggard in this because so many people think, ‘Well, you can’t do that in healthcare,’ as opposed to thinking, ‘How can we do that in healthcare?’”

4. Take advantage of telemedicine

Fortunately, technology to interact with patients remotely is almost ubiquitous. Even for practices with little experience in this arena, various vendors exist that can get secure, HIPAA-compliant technologies up and running quickly.

Various payers have issued guidance regarding reimbursement for telemedicine specific to COVID-19, and on March 6, Congress passed a law regarding Medicare coverage and payment for virtual services during a government-declared state of emergency. Some of the rules about HIPAA compliance in telemedicine have been eased for this emergency.

But even with well-established telemedicine modalities in place, it’s crunch time for applying it to COVID-19. “You need to find a way to have telemedicine available and use it, because depending on how this goes, that’s going to be clearly the safest, best way to care for a huge number of people,” said Darryl Elmouchi, MD, MBA, chief medical officer of Spectrum Health System and president of Spectrum Health Medical Group in Michigan.

“What we recognize now, both with our past experience with telehealth for many years and specifically with this coronavirus testing we’ve done, is that it’s incredibly useful both for the clinicians and the patients,” Elmouchi said.

One possibility to consider is the tactic used by Spectrum, a large integrated healthcare system. The company mobilized its existing telemedicine program to offer free virtual screenings for anyone in Michigan showing possible symptoms of COVID-19. “We wanted to keep people out of our clinics, emergency rooms, and urgent care centers if they didn’t need to be there, and help allay fears,” he said.

Elmouchi said his company faced the problems that other physicians would also have to deal with. “It was a ton of work with a dedicated team that was focused on this. The hardest part was probably trying to determine how we can staff it,” he said.

With their dedicated virtual team still seeing regularly scheduled virtual patients, the system had to reassign its traditional teams, such as urgent care and primary care clinicians, to the virtual screening effort. “Then we had to figure out how we could operationalize it. It was a lot of work,” Elmouchi said.

Telemedicine capabilities are not limited to screening patients, but can also be used to stay in touch with patients who may be quarantined and provide follow-up care, he noted.

5. Identify COVID-19 testing sites

Access to tests remains a problem in the US, but is improving by the week. For practices that can attain the tests themselves, it will still require some creativity to administer them with as little risk as possible. In South Korea, for example, and increasingly in the United States, healthcare organizations are instructing patients waiting to be tested to stay in their cars and have a practitioner wearing the proper PPE go out to patients to test them there.

Alternatively, some practices may opt to have PPE-wearing staff members bring PPE to patients in their cars and then escort them to a designated testing area in the building —through the back door if noninfected patients are still being seen.

“Once in the office, you still need to isolate virus patients in any way you can,” Dahl said. “In fact, you want a negative-pressure environment if possible, with the air being sucked out rather than circulating,” he said, adding that a large restroom with a ventilation system could be repurposed as a makeshift exam room.

Community testing sites are another possibility, given proper coordination with other healthcare organizations and community officials. Siddiqui has been working with several communities in which individual clinics and hospitals are unable to handle testing on their own, and have instead collaborated to create community testing sites in tents on local athletic fields.

“One of our communities is looking at using the local college parking lot to do drive-through testing there,” he said. “We really need to embrace collaboration much more than we’ve ever done.”

Collaboration also requires sharing supplies and PPE, noted Dahl. “Don’t hoard them because of the shortage. Look at your inventory and make sure you can help out whomever you may be sending patients to.” And if your office is falling short, Dahl advises checking with offices in your community that may be closing — such as dentists or plastic surgeons — for supplies you can purchase or simply have.

The US Food and Drug Administration has issued some guidance to healthcare providers about shortages of surgical masks and gowns, including advice about reusable cloth alternatives to gowns.

In addition, some hospitals have asked clinicians to keep their masks and provided guidance on how to conserve supplies.

6. Preparing to potentially shut down

A temporary closure may be inevitable for some practices. “Maybe the physician owners will not feel like they have a choice,” said Morgan. “They might feel like they want to stay open for as long as they can; but if it’s not safe for patients or not safe for employees, maybe they’ll feel it’s better if they check out for a bit.”

Should practices make the decision to close or reduce hours, multimodal communication with patients and the public is paramount. Patients will want to know whom to call if they are feeling ill for any reason, where to seek care, and when the practice expects to reopen. Again, proactive outreach will be more efficient and comforting to patients.

Handling financial ramifications of closure is a top priority as well, and will require a full understanding of what is and isn’t covered by the practice’s business interruption insurance. Practices that don’t have a line of credit should reach out to banks and the Small Business Administration immediately, according to Dahl. Practices that have lines of credit already may want to ask for an increase, added Morgan.

Protecting employees’ income is challenging as well. For employees who are furloughed, consider allowing them to use their sick and vacation time during the shutdown — and possibly let staff ‘borrow’ not-yet accrued paid time off.

“However, there’s a risk with certain jobs in a medical practice that tend to have extremely high turnover, so physicians and administrators may be reluctant to pay people too much because they don’t know for sure those employees will come back to those jobs,” Morgan said. “On the other hand, if you have had a stable team for a very long time and feel confident that those employees are going to stay, then you may make a different decision.”

7. Seize work-from-home opportunities

Even if the practice isn’t seeing patients, there may be opportunities for some employees, such as billers and schedulers, to continue to work from home,” Morgan noted. Particularly if a practice is behind on its billing, a closure or slowdown is an ideal time to catch up. This measure will keep at least some people working — perhaps including some individuals who can be cross-trained to do other tasks — and maintain some cashflow when the practice needs it most.

Other remote-friendly jobs that often fall by the wayside when practices are busy include marketing tasks such as setting up or updating Google business pages, Healthgrades profiles, and so on, noted Morgan.

“Another thing that can be even more important, and is often overlooked, is making sure health plan directories have correct information about your practice,” she added. “These are pesky, often tedious tasks that may require repeated contact with health plans to fix things — perfect things to do when the office is not busy or closed.”

For administrators and billers, if the practice is able to keep paying these employees while partially or fully closed, it can also be an excellent time to do the sort of analysis that takes a lot of focused attention and is hard to do when busy. Some examples: a detailed comparison of payer performance, analysis of referral patterns, or a review of coding accuracy, Morgan suggested.

Although practices have varying levels of comfort in letting employees work from home, it’s not much different from working with external billing or scheduling services that have grown more popular in recent years, Morgan said.

As with many technologies, HIPAA is a leading concern, though it needn’t be, according to Morgan. “If you are on a cloud-based electronic medical record and practice management system, there’s a good chance that it’s very straightforward to set someone up to work from elsewhere and have that data be secure,” she said.

Finally, as the crisis begins to abate, practices must keep working in teams to evaluate and structure an orderly return to business as usual, gleaning best practices from colleagues whenever possible.

“I would tell practices this is not a time when anyone is competing with anyone,” said Elmouchi. “The more collaboration between practices and health systems that have larger resources, the better.”

This article was originally published on Medscape.com.
 

At one large practice in Bergen County, New Jersey, the waiting room is empty — but its patients are still receiving care. As of mid-March, the practice is still operating, thanks to the group’s willingness to adapt its work flow, sometimes radically, to mitigate the threat of the COVID-19 pandemic.

For example, patients now call the receptionist from their vehicles when they arrive, and wait there until receiving a call back telling them the clinician is ready. The practice has also started using telemedicine for the first time, to the extent it can be adopted in a hurry, and some clinicians are working from home on tasks such as medication refills.

Still, the rapidly increasing numbers of COVID-19 cases in the United States raises the possibility that some physician offices will decide or be forced to close temporarily, as occurred in London last month.

Many practices across the country are having to adjust the way they operate, amid daily changes in the pandemic. What should you do to adapt to this new way of operating your practice?

1. Create a task force to manage change

The readiness of medical practices to address the myriad challenges posed by this crisis has so far been a mixed bag, said Owen Dahl, MBA, a Texas-based medical practice management consultant. “Leadership is going to have to assess what’s happening in the community, what’s happening with staff members who may or may not have the disease and may or may not have to self-quarantine,” Dahl said.

The physicians, the administrator, CEO, or managing partner should be involved in decision making as the global crisis unfolds, added Laurie Morgan, MBA, a California-based practice management consultant. And depending on the size of the practice, it may be useful to delegate specific components of this work to various department managers or other individuals in the group.

The team should assess:

• Recommendations and/or mandates from local, state, and federal governments
• Guidance from specialty and state medical societies
• How to triage patients over the phone, virtual visits, or referral to an alternate site of care
• Where to send patients for testing
• The practice’s inventory of personal protective equipment (PPE)
• Review of and possible revision of current infection control policies
• Possible collaborations within the community
• Reimbursement policies for suspected COVID-19 triage, testing, and follow-up treatment — in office or virtually
• Whether some employees’ work (eg, billing, coding) can be done remotely
• Options for paying personnel in the case of a temporary shutdown
• What’s covered and excluded by the group’s business interruption insurance

2. Consider postponing nonessential appointments

What’s more, it’s crucial for practices to form a strategy that does not involve bringing patients into the office, said Javeed Siddiqui, MD, MPH, an infectious disease physician, epidemiologist, and chief medical officer of TeleMed2U. “One thing we really have to recognize in this pandemic is that we don’t want people going and sitting in our waiting room. We don’t want people coming, and not only exposing other patients, but also further exposing staff. Forward triaging is going to be essential in this type of pandemic.”

Reliant Medical Group, with multiple locations in Massachusetts, for example, announced to patients recently that it will postpone appointments for some routine and elective procedures, as determined by the group’s physicians and clinical staff.

“Taking this step will help limit the number of people passing through our facilities, which will help slow the spread of illness [as recommended by the CDC],” noted an email blast to patients.

3. Overcommunicate to patients

With a situation as dynamic and unprecedented as this, constant and clear communication with patients is crucial. “In general, in my experience, practices don’t realize how much communication is necessary,” said Morgan. “In order to be effective and get the word out, you have to be overcommunicating.”

Today’s practices have multiple ways to communicate to keep people informed, including email, text messaging, social media, patient portals, and even local television and radio.

One email or text message to the patient population can help direct them to the appropriate streams of information. Helping direct patients to updated information is critical.

In contrast, having the front desk field multitudes of calls from concerned patients ties up precious resources, according Siddiqui. “Right now, practices are absolutely inundated, patients are waiting on hold, and that creates a great deal of frustration,” he said.

“We really need to take a page from every other industry in the United States, and that is using secure SMS, email communication, and telehealth,” Siddiqui said. “Healthcare generally tends to be a laggard in this because so many people think, ‘Well, you can’t do that in healthcare,’ as opposed to thinking, ‘How can we do that in healthcare?’”

4. Take advantage of telemedicine

Fortunately, technology to interact with patients remotely is almost ubiquitous. Even for practices with little experience in this arena, various vendors exist that can get secure, HIPAA-compliant technologies up and running quickly.

Various payers have issued guidance regarding reimbursement for telemedicine specific to COVID-19, and on March 6, Congress passed a law regarding Medicare coverage and payment for virtual services during a government-declared state of emergency. Some of the rules about HIPAA compliance in telemedicine have been eased for this emergency.

But even with well-established telemedicine modalities in place, it’s crunch time for applying it to COVID-19. “You need to find a way to have telemedicine available and use it, because depending on how this goes, that’s going to be clearly the safest, best way to care for a huge number of people,” said Darryl Elmouchi, MD, MBA, chief medical officer of Spectrum Health System and president of Spectrum Health Medical Group in Michigan.

“What we recognize now, both with our past experience with telehealth for many years and specifically with this coronavirus testing we’ve done, is that it’s incredibly useful both for the clinicians and the patients,” Elmouchi said.

One possibility to consider is the tactic used by Spectrum, a large integrated healthcare system. The company mobilized its existing telemedicine program to offer free virtual screenings for anyone in Michigan showing possible symptoms of COVID-19. “We wanted to keep people out of our clinics, emergency rooms, and urgent care centers if they didn’t need to be there, and help allay fears,” he said.

Elmouchi said his company faced the problems that other physicians would also have to deal with. “It was a ton of work with a dedicated team that was focused on this. The hardest part was probably trying to determine how we can staff it,” he said.

With their dedicated virtual team still seeing regularly scheduled virtual patients, the system had to reassign its traditional teams, such as urgent care and primary care clinicians, to the virtual screening effort. “Then we had to figure out how we could operationalize it. It was a lot of work,” Elmouchi said.

Telemedicine capabilities are not limited to screening patients, but can also be used to stay in touch with patients who may be quarantined and provide follow-up care, he noted.

5. Identify COVID-19 testing sites

Access to tests remains a problem in the US, but is improving by the week. For practices that can attain the tests themselves, it will still require some creativity to administer them with as little risk as possible. In South Korea, for example, and increasingly in the United States, healthcare organizations are instructing patients waiting to be tested to stay in their cars and have a practitioner wearing the proper PPE go out to patients to test them there.

Alternatively, some practices may opt to have PPE-wearing staff members bring PPE to patients in their cars and then escort them to a designated testing area in the building —through the back door if noninfected patients are still being seen.

“Once in the office, you still need to isolate virus patients in any way you can,” Dahl said. “In fact, you want a negative-pressure environment if possible, with the air being sucked out rather than circulating,” he said, adding that a large restroom with a ventilation system could be repurposed as a makeshift exam room.

Community testing sites are another possibility, given proper coordination with other healthcare organizations and community officials. Siddiqui has been working with several communities in which individual clinics and hospitals are unable to handle testing on their own, and have instead collaborated to create community testing sites in tents on local athletic fields.

“One of our communities is looking at using the local college parking lot to do drive-through testing there,” he said. “We really need to embrace collaboration much more than we’ve ever done.”

Collaboration also requires sharing supplies and PPE, noted Dahl. “Don’t hoard them because of the shortage. Look at your inventory and make sure you can help out whomever you may be sending patients to.” And if your office is falling short, Dahl advises checking with offices in your community that may be closing — such as dentists or plastic surgeons — for supplies you can purchase or simply have.

The US Food and Drug Administration has issued some guidance to healthcare providers about shortages of surgical masks and gowns, including advice about reusable cloth alternatives to gowns.

In addition, some hospitals have asked clinicians to keep their masks and provided guidance on how to conserve supplies.

6. Preparing to potentially shut down

A temporary closure may be inevitable for some practices. “Maybe the physician owners will not feel like they have a choice,” said Morgan. “They might feel like they want to stay open for as long as they can; but if it’s not safe for patients or not safe for employees, maybe they’ll feel it’s better if they check out for a bit.”

Should practices make the decision to close or reduce hours, multimodal communication with patients and the public is paramount. Patients will want to know whom to call if they are feeling ill for any reason, where to seek care, and when the practice expects to reopen. Again, proactive outreach will be more efficient and comforting to patients.

Handling financial ramifications of closure is a top priority as well, and will require a full understanding of what is and isn’t covered by the practice’s business interruption insurance. Practices that don’t have a line of credit should reach out to banks and the Small Business Administration immediately, according to Dahl. Practices that have lines of credit already may want to ask for an increase, added Morgan.

Protecting employees’ income is challenging as well. For employees who are furloughed, consider allowing them to use their sick and vacation time during the shutdown — and possibly let staff ‘borrow’ not-yet accrued paid time off.

“However, there’s a risk with certain jobs in a medical practice that tend to have extremely high turnover, so physicians and administrators may be reluctant to pay people too much because they don’t know for sure those employees will come back to those jobs,” Morgan said. “On the other hand, if you have had a stable team for a very long time and feel confident that those employees are going to stay, then you may make a different decision.”

7. Seize work-from-home opportunities

Even if the practice isn’t seeing patients, there may be opportunities for some employees, such as billers and schedulers, to continue to work from home,” Morgan noted. Particularly if a practice is behind on its billing, a closure or slowdown is an ideal time to catch up. This measure will keep at least some people working — perhaps including some individuals who can be cross-trained to do other tasks — and maintain some cashflow when the practice needs it most.

Other remote-friendly jobs that often fall by the wayside when practices are busy include marketing tasks such as setting up or updating Google business pages, Healthgrades profiles, and so on, noted Morgan.

“Another thing that can be even more important, and is often overlooked, is making sure health plan directories have correct information about your practice,” she added. “These are pesky, often tedious tasks that may require repeated contact with health plans to fix things — perfect things to do when the office is not busy or closed.”

For administrators and billers, if the practice is able to keep paying these employees while partially or fully closed, it can also be an excellent time to do the sort of analysis that takes a lot of focused attention and is hard to do when busy. Some examples: a detailed comparison of payer performance, analysis of referral patterns, or a review of coding accuracy, Morgan suggested.

Although practices have varying levels of comfort in letting employees work from home, it’s not much different from working with external billing or scheduling services that have grown more popular in recent years, Morgan said.

As with many technologies, HIPAA is a leading concern, though it needn’t be, according to Morgan. “If you are on a cloud-based electronic medical record and practice management system, there’s a good chance that it’s very straightforward to set someone up to work from elsewhere and have that data be secure,” she said.

Finally, as the crisis begins to abate, practices must keep working in teams to evaluate and structure an orderly return to business as usual, gleaning best practices from colleagues whenever possible.

“I would tell practices this is not a time when anyone is competing with anyone,” said Elmouchi. “The more collaboration between practices and health systems that have larger resources, the better.”

This article was originally published on Medscape.com.
 

At one large practice in Bergen County, New Jersey, the waiting room is empty — but its patients are still receiving care. As of mid-March, the practice is still operating, thanks to the group’s willingness to adapt its work flow, sometimes radically, to mitigate the threat of the COVID-19 pandemic.

For example, patients now call the receptionist from their vehicles when they arrive, and wait there until receiving a call back telling them the clinician is ready. The practice has also started using telemedicine for the first time, to the extent it can be adopted in a hurry, and some clinicians are working from home on tasks such as medication refills.

Still, the rapidly increasing numbers of COVID-19 cases in the United States raises the possibility that some physician offices will decide or be forced to close temporarily, as occurred in London last month.

Many practices across the country are having to adjust the way they operate, amid daily changes in the pandemic. What should you do to adapt to this new way of operating your practice?

1. Create a task force to manage change

The readiness of medical practices to address the myriad challenges posed by this crisis has so far been a mixed bag, said Owen Dahl, MBA, a Texas-based medical practice management consultant. “Leadership is going to have to assess what’s happening in the community, what’s happening with staff members who may or may not have the disease and may or may not have to self-quarantine,” Dahl said.

The physicians, the administrator, CEO, or managing partner should be involved in decision making as the global crisis unfolds, added Laurie Morgan, MBA, a California-based practice management consultant. And depending on the size of the practice, it may be useful to delegate specific components of this work to various department managers or other individuals in the group.

The team should assess:

• Recommendations and/or mandates from local, state, and federal governments
• Guidance from specialty and state medical societies
• How to triage patients over the phone, virtual visits, or referral to an alternate site of care
• Where to send patients for testing
• The practice’s inventory of personal protective equipment (PPE)
• Review of and possible revision of current infection control policies
• Possible collaborations within the community
• Reimbursement policies for suspected COVID-19 triage, testing, and follow-up treatment — in office or virtually
• Whether some employees’ work (eg, billing, coding) can be done remotely
• Options for paying personnel in the case of a temporary shutdown
• What’s covered and excluded by the group’s business interruption insurance

2. Consider postponing nonessential appointments

What’s more, it’s crucial for practices to form a strategy that does not involve bringing patients into the office, said Javeed Siddiqui, MD, MPH, an infectious disease physician, epidemiologist, and chief medical officer of TeleMed2U. “One thing we really have to recognize in this pandemic is that we don’t want people going and sitting in our waiting room. We don’t want people coming, and not only exposing other patients, but also further exposing staff. Forward triaging is going to be essential in this type of pandemic.”

Reliant Medical Group, with multiple locations in Massachusetts, for example, announced to patients recently that it will postpone appointments for some routine and elective procedures, as determined by the group’s physicians and clinical staff.

“Taking this step will help limit the number of people passing through our facilities, which will help slow the spread of illness [as recommended by the CDC],” noted an email blast to patients.

3. Overcommunicate to patients

With a situation as dynamic and unprecedented as this, constant and clear communication with patients is crucial. “In general, in my experience, practices don’t realize how much communication is necessary,” said Morgan. “In order to be effective and get the word out, you have to be overcommunicating.”

Today’s practices have multiple ways to communicate to keep people informed, including email, text messaging, social media, patient portals, and even local television and radio.

One email or text message to the patient population can help direct them to the appropriate streams of information. Helping direct patients to updated information is critical.

In contrast, having the front desk field multitudes of calls from concerned patients ties up precious resources, according Siddiqui. “Right now, practices are absolutely inundated, patients are waiting on hold, and that creates a great deal of frustration,” he said.

“We really need to take a page from every other industry in the United States, and that is using secure SMS, email communication, and telehealth,” Siddiqui said. “Healthcare generally tends to be a laggard in this because so many people think, ‘Well, you can’t do that in healthcare,’ as opposed to thinking, ‘How can we do that in healthcare?’”

4. Take advantage of telemedicine

Fortunately, technology to interact with patients remotely is almost ubiquitous. Even for practices with little experience in this arena, various vendors exist that can get secure, HIPAA-compliant technologies up and running quickly.

Various payers have issued guidance regarding reimbursement for telemedicine specific to COVID-19, and on March 6, Congress passed a law regarding Medicare coverage and payment for virtual services during a government-declared state of emergency. Some of the rules about HIPAA compliance in telemedicine have been eased for this emergency.

But even with well-established telemedicine modalities in place, it’s crunch time for applying it to COVID-19. “You need to find a way to have telemedicine available and use it, because depending on how this goes, that’s going to be clearly the safest, best way to care for a huge number of people,” said Darryl Elmouchi, MD, MBA, chief medical officer of Spectrum Health System and president of Spectrum Health Medical Group in Michigan.

“What we recognize now, both with our past experience with telehealth for many years and specifically with this coronavirus testing we’ve done, is that it’s incredibly useful both for the clinicians and the patients,” Elmouchi said.

One possibility to consider is the tactic used by Spectrum, a large integrated healthcare system. The company mobilized its existing telemedicine program to offer free virtual screenings for anyone in Michigan showing possible symptoms of COVID-19. “We wanted to keep people out of our clinics, emergency rooms, and urgent care centers if they didn’t need to be there, and help allay fears,” he said.

Elmouchi said his company faced the problems that other physicians would also have to deal with. “It was a ton of work with a dedicated team that was focused on this. The hardest part was probably trying to determine how we can staff it,” he said.

With their dedicated virtual team still seeing regularly scheduled virtual patients, the system had to reassign its traditional teams, such as urgent care and primary care clinicians, to the virtual screening effort. “Then we had to figure out how we could operationalize it. It was a lot of work,” Elmouchi said.

Telemedicine capabilities are not limited to screening patients, but can also be used to stay in touch with patients who may be quarantined and provide follow-up care, he noted.

5. Identify COVID-19 testing sites

Access to tests remains a problem in the US, but is improving by the week. For practices that can attain the tests themselves, it will still require some creativity to administer them with as little risk as possible. In South Korea, for example, and increasingly in the United States, healthcare organizations are instructing patients waiting to be tested to stay in their cars and have a practitioner wearing the proper PPE go out to patients to test them there.

Alternatively, some practices may opt to have PPE-wearing staff members bring PPE to patients in their cars and then escort them to a designated testing area in the building —through the back door if noninfected patients are still being seen.

“Once in the office, you still need to isolate virus patients in any way you can,” Dahl said. “In fact, you want a negative-pressure environment if possible, with the air being sucked out rather than circulating,” he said, adding that a large restroom with a ventilation system could be repurposed as a makeshift exam room.

Community testing sites are another possibility, given proper coordination with other healthcare organizations and community officials. Siddiqui has been working with several communities in which individual clinics and hospitals are unable to handle testing on their own, and have instead collaborated to create community testing sites in tents on local athletic fields.

“One of our communities is looking at using the local college parking lot to do drive-through testing there,” he said. “We really need to embrace collaboration much more than we’ve ever done.”

Collaboration also requires sharing supplies and PPE, noted Dahl. “Don’t hoard them because of the shortage. Look at your inventory and make sure you can help out whomever you may be sending patients to.” And if your office is falling short, Dahl advises checking with offices in your community that may be closing — such as dentists or plastic surgeons — for supplies you can purchase or simply have.

The US Food and Drug Administration has issued some guidance to healthcare providers about shortages of surgical masks and gowns, including advice about reusable cloth alternatives to gowns.

In addition, some hospitals have asked clinicians to keep their masks and provided guidance on how to conserve supplies.

6. Preparing to potentially shut down

A temporary closure may be inevitable for some practices. “Maybe the physician owners will not feel like they have a choice,” said Morgan. “They might feel like they want to stay open for as long as they can; but if it’s not safe for patients or not safe for employees, maybe they’ll feel it’s better if they check out for a bit.”

Should practices make the decision to close or reduce hours, multimodal communication with patients and the public is paramount. Patients will want to know whom to call if they are feeling ill for any reason, where to seek care, and when the practice expects to reopen. Again, proactive outreach will be more efficient and comforting to patients.

Handling financial ramifications of closure is a top priority as well, and will require a full understanding of what is and isn’t covered by the practice’s business interruption insurance. Practices that don’t have a line of credit should reach out to banks and the Small Business Administration immediately, according to Dahl. Practices that have lines of credit already may want to ask for an increase, added Morgan.

Protecting employees’ income is challenging as well. For employees who are furloughed, consider allowing them to use their sick and vacation time during the shutdown — and possibly let staff ‘borrow’ not-yet accrued paid time off.

“However, there’s a risk with certain jobs in a medical practice that tend to have extremely high turnover, so physicians and administrators may be reluctant to pay people too much because they don’t know for sure those employees will come back to those jobs,” Morgan said. “On the other hand, if you have had a stable team for a very long time and feel confident that those employees are going to stay, then you may make a different decision.”

7. Seize work-from-home opportunities

Even if the practice isn’t seeing patients, there may be opportunities for some employees, such as billers and schedulers, to continue to work from home,” Morgan noted. Particularly if a practice is behind on its billing, a closure or slowdown is an ideal time to catch up. This measure will keep at least some people working — perhaps including some individuals who can be cross-trained to do other tasks — and maintain some cashflow when the practice needs it most.

Other remote-friendly jobs that often fall by the wayside when practices are busy include marketing tasks such as setting up or updating Google business pages, Healthgrades profiles, and so on, noted Morgan.

“Another thing that can be even more important, and is often overlooked, is making sure health plan directories have correct information about your practice,” she added. “These are pesky, often tedious tasks that may require repeated contact with health plans to fix things — perfect things to do when the office is not busy or closed.”

For administrators and billers, if the practice is able to keep paying these employees while partially or fully closed, it can also be an excellent time to do the sort of analysis that takes a lot of focused attention and is hard to do when busy. Some examples: a detailed comparison of payer performance, analysis of referral patterns, or a review of coding accuracy, Morgan suggested.

Although practices have varying levels of comfort in letting employees work from home, it’s not much different from working with external billing or scheduling services that have grown more popular in recent years, Morgan said.

As with many technologies, HIPAA is a leading concern, though it needn’t be, according to Morgan. “If you are on a cloud-based electronic medical record and practice management system, there’s a good chance that it’s very straightforward to set someone up to work from elsewhere and have that data be secure,” she said.

Finally, as the crisis begins to abate, practices must keep working in teams to evaluate and structure an orderly return to business as usual, gleaning best practices from colleagues whenever possible.

“I would tell practices this is not a time when anyone is competing with anyone,” said Elmouchi. “The more collaboration between practices and health systems that have larger resources, the better.”

This article was originally published on Medscape.com.
 

As the coronavirus pandemic escalates in the United States, Medscape Oncology reached out to a group of our contributors and asked them to provide their perspective on how their oncology departments and centers are preparing. Here are their responses to a number of issues facing oncologists in the US and around the world.
 

Have you shifted nonurgent follow-up visits to telemedicine, either via video or phone?

Kathy Miller, MD, Associate Director of Indiana University Simon Cancer Center: We are reviewing our clinic schedules and identifying “routine” follow-up patients who can be rescheduled. When patients are contacted to reschedule, they are asked if they have any urgent, immediate concerns that need to be addressed before the new appointment. If yes, they are offered a virtual visit.

Don Dizon, MD, Director of Women’s Cancers, Lifespan Cancer Institute; Director of Medical Oncology, Rhode Island Hospital: We have started to do this in preparation for a surge of people with COVID-19. Patients who are in long-term follow-up (no evidence of disease at 3 years or longer, being seen annually) or those in routine surveillance after curative treatment (that is, seen every 3 months) as well as those being seen for supportive care–type visits, like sexual health or survivorship, are all being contacted and visits are being moved to telehealth.

Jeffrey S. Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at NYU Langone Medical Center: Yes. Any follow-up, nontreatment visits are done by phone or video if the patient agrees. (They all have).
 

Have you delayed or canceled cancer surgeries?

Ravi B. Parikh, MD, MPP, Medical oncologist at the University of Pennsylvania and the Philadelphia VA Medical Center: The University of Pennsylvania has taken this seriously. We’ve canceled all elective surgeries, have ramped up our telemedicine (video and phone) capabilities significantly, are limiting our appointments mostly to on-treatment visits, and have been asked to reconsider regular scans and reviews.

Dizon: We have not done this. There are apparently differences in interpretation in what institutions might mean as “elective surgeries.” At our institution, surgery for invasive malignancies is not elective. However, this may (or will) change if resources become an issue.

Lidia Schapira, MD, Associate Professor of Medicine and Director of Cancer Survivorship at the Stanford Comprehensive Cancer Institute: Delaying elective surgery is something that hospitals here have already implemented, and I imagine that this trend will spread. But it may be difficult to decide in situations that are not exactly “life-saving” but where an earlier intervention could preserve function or improve quality of life.

Mark A. Lewis, MD, Director of Gastrointestinal Oncology at Intermountain Healthcare in Utah: Cancer surgeries have not been deemed elective or delayed.

Have you delayed or altered the delivery of potentially immune-comprising treatments?

David Kerr, MD, Professor of Cancer Medicine at the University of Oxford in England: We are considering delaying initiation of our adjuvant colorectal cancer treatments, as we have data from our own QUASAR trials suggesting that patients who commence chemotherapy between 2 and 6 weeks do equally as well as those who begin 6-12 weeks after surgery.

Parikh: I personally haven’t delayed giving chemotherapy to avoid immune compromise, but I believe some others may have. It’s a delicate balance between wanting to ensure cancer control and making sure we are flattening the curve. As an example, though, I delayed three on-treatment visits for my clinic last Monday, and I converted 70% of my visits to telemedicine. However, I’m a genitourinary cancer specialist and the treatments I give are very different from others.

Lewis: The most difficult calculus is around adjuvant therapy. For metastatic patients, I am trying to use the least immunosuppressive regimen possible that will still control their disease. As you can imagine, it’s an assessment of competing risks.

Schapira: Patients who need essential anticancer therapy should still get it, but attempts to deintensify therapy should continue—for example, holding or postponing treatment without harm (based on evidence, not opinion). This may be possible for patients considering hormonal therapies for breast or prostate cancer.

Patients who need radiation should discuss the timing with their radiation oncologist. In some cases, it may be possible to delay treatment without affecting outcomes, but these decisions should be made carefully. Alternatively, shorter courses of radiation may be appropriate.
 

Have you advised your own patients differently given the high risk to cancer patients?

Kerr: We have factored potential infection with the virus into discussions where the benefits of chemotherapy are very marginal. This could tip the balance toward the patient deciding not to pursue chemotherapy.

Dizon: The data from China are not entirely crystal-clear. While they noted that people with active cancer and those who had a history of cancer are at increased risk for more severe infections and worse outcomes, the Chinese cohort was small, and compared with people without cancer, it tended to be much older and to be smokers (former or current). Having said this, we are counseling everyone about the importance of social distancing, washing hands, and not touching your face.

Lewis: If I have a complete blood count with a differential that includes lymphocytes, I can advise my lymphopenic patients (who are particularly vulnerable to viral infection) to take special precautions regarding social distancing in their own families.
 

Have any of your hospitalized patients been affected by policy changes to prepare beds/departments for the expected increase in COVID-19–positive patients?

Weber: Not yet.

Dizon: No, not at the moment.
 

Have you been asked to assist with other services or COVID-19 task forces?

Dizon: I am keenly involved in the preparations and modifications to procedures, including staffing decisions in outpatient, movement to telehealth, and work-from-home policies.

Lewis: I am engaged in system-wide COVID-19 efforts around oncology.

Kerr: Perhaps oddest of all, I am learning with some of our junior doctors to care for ventilated patients. I still consider myself enough of a general physician that I would hope to be able to contribute to the truly sick, but I accept that I do need an appropriate refresher course.

Bishal Gyawali, MD, PhD, medical oncologist at Queen’s University Cancer Research Institute: Queen’s Hospital medical students are now volunteering to help with daycare, groceries, and other tasks for staff who are working in the hospital.
 

Are you experiencing any shortages in personal protective equipment (PPE) at your center?

Miller: Some supplies are running short, though none are frankly out at this point. However, rationing and controls are in place to stretch the supplies as far as possible, including reusing some PPE.

Dizon: We are rationing face masks and N95 respirators, eye shields, and even surgical scrubs. We are talking about postponing elective surgery to save PPE but are not yet to that point. We’re asking that face masks be reused for at least 2 days, maybe longer. PPEs are one per day. Scrubs are kept secure.

Lewis: We are being very careful not to overuse PPE but currently have an adequate inventory. We have had to move gloves and masks to areas where they are not accessible to the general public, as otherwise they were being stolen (this started weeks ago).

Kerr: Our National Health System has an adequate supply of PPE equipment centrally, but there seems to be a problem with distribution, as some hospitals are reporting shortages.

Weber: Masks are in short supply, so they are being used for several days if not wet. We are short of plastic gowns and are using paper chemo gowns. Similar story at many places.

This article first appeared on Medscape.com.

As the coronavirus pandemic escalates in the United States, Medscape Oncology reached out to a group of our contributors and asked them to provide their perspective on how their oncology departments and centers are preparing. Here are their responses to a number of issues facing oncologists in the US and around the world.
 

Have you shifted nonurgent follow-up visits to telemedicine, either via video or phone?

Kathy Miller, MD, Associate Director of Indiana University Simon Cancer Center: We are reviewing our clinic schedules and identifying “routine” follow-up patients who can be rescheduled. When patients are contacted to reschedule, they are asked if they have any urgent, immediate concerns that need to be addressed before the new appointment. If yes, they are offered a virtual visit.

Don Dizon, MD, Director of Women’s Cancers, Lifespan Cancer Institute; Director of Medical Oncology, Rhode Island Hospital: We have started to do this in preparation for a surge of people with COVID-19. Patients who are in long-term follow-up (no evidence of disease at 3 years or longer, being seen annually) or those in routine surveillance after curative treatment (that is, seen every 3 months) as well as those being seen for supportive care–type visits, like sexual health or survivorship, are all being contacted and visits are being moved to telehealth.

Jeffrey S. Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at NYU Langone Medical Center: Yes. Any follow-up, nontreatment visits are done by phone or video if the patient agrees. (They all have).
 

Have you delayed or canceled cancer surgeries?

Ravi B. Parikh, MD, MPP, Medical oncologist at the University of Pennsylvania and the Philadelphia VA Medical Center: The University of Pennsylvania has taken this seriously. We’ve canceled all elective surgeries, have ramped up our telemedicine (video and phone) capabilities significantly, are limiting our appointments mostly to on-treatment visits, and have been asked to reconsider regular scans and reviews.

Dizon: We have not done this. There are apparently differences in interpretation in what institutions might mean as “elective surgeries.” At our institution, surgery for invasive malignancies is not elective. However, this may (or will) change if resources become an issue.

Lidia Schapira, MD, Associate Professor of Medicine and Director of Cancer Survivorship at the Stanford Comprehensive Cancer Institute: Delaying elective surgery is something that hospitals here have already implemented, and I imagine that this trend will spread. But it may be difficult to decide in situations that are not exactly “life-saving” but where an earlier intervention could preserve function or improve quality of life.

Mark A. Lewis, MD, Director of Gastrointestinal Oncology at Intermountain Healthcare in Utah: Cancer surgeries have not been deemed elective or delayed.

Have you delayed or altered the delivery of potentially immune-comprising treatments?

David Kerr, MD, Professor of Cancer Medicine at the University of Oxford in England: We are considering delaying initiation of our adjuvant colorectal cancer treatments, as we have data from our own QUASAR trials suggesting that patients who commence chemotherapy between 2 and 6 weeks do equally as well as those who begin 6-12 weeks after surgery.

Parikh: I personally haven’t delayed giving chemotherapy to avoid immune compromise, but I believe some others may have. It’s a delicate balance between wanting to ensure cancer control and making sure we are flattening the curve. As an example, though, I delayed three on-treatment visits for my clinic last Monday, and I converted 70% of my visits to telemedicine. However, I’m a genitourinary cancer specialist and the treatments I give are very different from others.

Lewis: The most difficult calculus is around adjuvant therapy. For metastatic patients, I am trying to use the least immunosuppressive regimen possible that will still control their disease. As you can imagine, it’s an assessment of competing risks.

Schapira: Patients who need essential anticancer therapy should still get it, but attempts to deintensify therapy should continue—for example, holding or postponing treatment without harm (based on evidence, not opinion). This may be possible for patients considering hormonal therapies for breast or prostate cancer.

Patients who need radiation should discuss the timing with their radiation oncologist. In some cases, it may be possible to delay treatment without affecting outcomes, but these decisions should be made carefully. Alternatively, shorter courses of radiation may be appropriate.
 

Have you advised your own patients differently given the high risk to cancer patients?

Kerr: We have factored potential infection with the virus into discussions where the benefits of chemotherapy are very marginal. This could tip the balance toward the patient deciding not to pursue chemotherapy.

Dizon: The data from China are not entirely crystal-clear. While they noted that people with active cancer and those who had a history of cancer are at increased risk for more severe infections and worse outcomes, the Chinese cohort was small, and compared with people without cancer, it tended to be much older and to be smokers (former or current). Having said this, we are counseling everyone about the importance of social distancing, washing hands, and not touching your face.

Lewis: If I have a complete blood count with a differential that includes lymphocytes, I can advise my lymphopenic patients (who are particularly vulnerable to viral infection) to take special precautions regarding social distancing in their own families.
 

Have any of your hospitalized patients been affected by policy changes to prepare beds/departments for the expected increase in COVID-19–positive patients?

Weber: Not yet.

Dizon: No, not at the moment.
 

Have you been asked to assist with other services or COVID-19 task forces?

Dizon: I am keenly involved in the preparations and modifications to procedures, including staffing decisions in outpatient, movement to telehealth, and work-from-home policies.

Lewis: I am engaged in system-wide COVID-19 efforts around oncology.

Kerr: Perhaps oddest of all, I am learning with some of our junior doctors to care for ventilated patients. I still consider myself enough of a general physician that I would hope to be able to contribute to the truly sick, but I accept that I do need an appropriate refresher course.

Bishal Gyawali, MD, PhD, medical oncologist at Queen’s University Cancer Research Institute: Queen’s Hospital medical students are now volunteering to help with daycare, groceries, and other tasks for staff who are working in the hospital.
 

Are you experiencing any shortages in personal protective equipment (PPE) at your center?

Miller: Some supplies are running short, though none are frankly out at this point. However, rationing and controls are in place to stretch the supplies as far as possible, including reusing some PPE.

Dizon: We are rationing face masks and N95 respirators, eye shields, and even surgical scrubs. We are talking about postponing elective surgery to save PPE but are not yet to that point. We’re asking that face masks be reused for at least 2 days, maybe longer. PPEs are one per day. Scrubs are kept secure.

Lewis: We are being very careful not to overuse PPE but currently have an adequate inventory. We have had to move gloves and masks to areas where they are not accessible to the general public, as otherwise they were being stolen (this started weeks ago).

Kerr: Our National Health System has an adequate supply of PPE equipment centrally, but there seems to be a problem with distribution, as some hospitals are reporting shortages.

Weber: Masks are in short supply, so they are being used for several days if not wet. We are short of plastic gowns and are using paper chemo gowns. Similar story at many places.

This article first appeared on Medscape.com.

As the coronavirus pandemic escalates in the United States, Medscape Oncology reached out to a group of our contributors and asked them to provide their perspective on how their oncology departments and centers are preparing. Here are their responses to a number of issues facing oncologists in the US and around the world.
 

Have you shifted nonurgent follow-up visits to telemedicine, either via video or phone?

Kathy Miller, MD, Associate Director of Indiana University Simon Cancer Center: We are reviewing our clinic schedules and identifying “routine” follow-up patients who can be rescheduled. When patients are contacted to reschedule, they are asked if they have any urgent, immediate concerns that need to be addressed before the new appointment. If yes, they are offered a virtual visit.

Don Dizon, MD, Director of Women’s Cancers, Lifespan Cancer Institute; Director of Medical Oncology, Rhode Island Hospital: We have started to do this in preparation for a surge of people with COVID-19. Patients who are in long-term follow-up (no evidence of disease at 3 years or longer, being seen annually) or those in routine surveillance after curative treatment (that is, seen every 3 months) as well as those being seen for supportive care–type visits, like sexual health or survivorship, are all being contacted and visits are being moved to telehealth.

Jeffrey S. Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at NYU Langone Medical Center: Yes. Any follow-up, nontreatment visits are done by phone or video if the patient agrees. (They all have).
 

Have you delayed or canceled cancer surgeries?

Ravi B. Parikh, MD, MPP, Medical oncologist at the University of Pennsylvania and the Philadelphia VA Medical Center: The University of Pennsylvania has taken this seriously. We’ve canceled all elective surgeries, have ramped up our telemedicine (video and phone) capabilities significantly, are limiting our appointments mostly to on-treatment visits, and have been asked to reconsider regular scans and reviews.

Dizon: We have not done this. There are apparently differences in interpretation in what institutions might mean as “elective surgeries.” At our institution, surgery for invasive malignancies is not elective. However, this may (or will) change if resources become an issue.

Lidia Schapira, MD, Associate Professor of Medicine and Director of Cancer Survivorship at the Stanford Comprehensive Cancer Institute: Delaying elective surgery is something that hospitals here have already implemented, and I imagine that this trend will spread. But it may be difficult to decide in situations that are not exactly “life-saving” but where an earlier intervention could preserve function or improve quality of life.

Mark A. Lewis, MD, Director of Gastrointestinal Oncology at Intermountain Healthcare in Utah: Cancer surgeries have not been deemed elective or delayed.

Have you delayed or altered the delivery of potentially immune-comprising treatments?

David Kerr, MD, Professor of Cancer Medicine at the University of Oxford in England: We are considering delaying initiation of our adjuvant colorectal cancer treatments, as we have data from our own QUASAR trials suggesting that patients who commence chemotherapy between 2 and 6 weeks do equally as well as those who begin 6-12 weeks after surgery.

Parikh: I personally haven’t delayed giving chemotherapy to avoid immune compromise, but I believe some others may have. It’s a delicate balance between wanting to ensure cancer control and making sure we are flattening the curve. As an example, though, I delayed three on-treatment visits for my clinic last Monday, and I converted 70% of my visits to telemedicine. However, I’m a genitourinary cancer specialist and the treatments I give are very different from others.

Lewis: The most difficult calculus is around adjuvant therapy. For metastatic patients, I am trying to use the least immunosuppressive regimen possible that will still control their disease. As you can imagine, it’s an assessment of competing risks.

Schapira: Patients who need essential anticancer therapy should still get it, but attempts to deintensify therapy should continue—for example, holding or postponing treatment without harm (based on evidence, not opinion). This may be possible for patients considering hormonal therapies for breast or prostate cancer.

Patients who need radiation should discuss the timing with their radiation oncologist. In some cases, it may be possible to delay treatment without affecting outcomes, but these decisions should be made carefully. Alternatively, shorter courses of radiation may be appropriate.
 

Have you advised your own patients differently given the high risk to cancer patients?

Kerr: We have factored potential infection with the virus into discussions where the benefits of chemotherapy are very marginal. This could tip the balance toward the patient deciding not to pursue chemotherapy.

Dizon: The data from China are not entirely crystal-clear. While they noted that people with active cancer and those who had a history of cancer are at increased risk for more severe infections and worse outcomes, the Chinese cohort was small, and compared with people without cancer, it tended to be much older and to be smokers (former or current). Having said this, we are counseling everyone about the importance of social distancing, washing hands, and not touching your face.

Lewis: If I have a complete blood count with a differential that includes lymphocytes, I can advise my lymphopenic patients (who are particularly vulnerable to viral infection) to take special precautions regarding social distancing in their own families.
 

Have any of your hospitalized patients been affected by policy changes to prepare beds/departments for the expected increase in COVID-19–positive patients?

Weber: Not yet.

Dizon: No, not at the moment.
 

Have you been asked to assist with other services or COVID-19 task forces?

Dizon: I am keenly involved in the preparations and modifications to procedures, including staffing decisions in outpatient, movement to telehealth, and work-from-home policies.

Lewis: I am engaged in system-wide COVID-19 efforts around oncology.

Kerr: Perhaps oddest of all, I am learning with some of our junior doctors to care for ventilated patients. I still consider myself enough of a general physician that I would hope to be able to contribute to the truly sick, but I accept that I do need an appropriate refresher course.

Bishal Gyawali, MD, PhD, medical oncologist at Queen’s University Cancer Research Institute: Queen’s Hospital medical students are now volunteering to help with daycare, groceries, and other tasks for staff who are working in the hospital.
 

Are you experiencing any shortages in personal protective equipment (PPE) at your center?

Miller: Some supplies are running short, though none are frankly out at this point. However, rationing and controls are in place to stretch the supplies as far as possible, including reusing some PPE.

Dizon: We are rationing face masks and N95 respirators, eye shields, and even surgical scrubs. We are talking about postponing elective surgery to save PPE but are not yet to that point. We’re asking that face masks be reused for at least 2 days, maybe longer. PPEs are one per day. Scrubs are kept secure.

Lewis: We are being very careful not to overuse PPE but currently have an adequate inventory. We have had to move gloves and masks to areas where they are not accessible to the general public, as otherwise they were being stolen (this started weeks ago).

Kerr: Our National Health System has an adequate supply of PPE equipment centrally, but there seems to be a problem with distribution, as some hospitals are reporting shortages.

Weber: Masks are in short supply, so they are being used for several days if not wet. We are short of plastic gowns and are using paper chemo gowns. Similar story at many places.

This article first appeared on Medscape.com.

One of a smartphone’s simplest features has become a powerful communication and coordination tool for metro Seattle’s critical care departments.

Anne B. Lipke, MD, is the medical director of Swedish Medical Center’s Issaquah, Wash., campus in suburban Seattle. In an audio interview, Dr. Lipke explains how texting has become a fast, effective component of Seattle’s critical care response to COVID-19. And she offers lessons for physicians across the country who may soon be seeing situations similar to Seattle’s.

trudd@mdedge.com

One of a smartphone’s simplest features has become a powerful communication and coordination tool for metro Seattle’s critical care departments.

Anne B. Lipke, MD, is the medical director of Swedish Medical Center’s Issaquah, Wash., campus in suburban Seattle. In an audio interview, Dr. Lipke explains how texting has become a fast, effective component of Seattle’s critical care response to COVID-19. And she offers lessons for physicians across the country who may soon be seeing situations similar to Seattle’s.

trudd@mdedge.com

One of a smartphone’s simplest features has become a powerful communication and coordination tool for metro Seattle’s critical care departments.

Anne B. Lipke, MD, is the medical director of Swedish Medical Center’s Issaquah, Wash., campus in suburban Seattle. In an audio interview, Dr. Lipke explains how texting has become a fast, effective component of Seattle’s critical care response to COVID-19. And she offers lessons for physicians across the country who may soon be seeing situations similar to Seattle’s.

trudd@mdedge.com

For almost a quarter century, Julie Powers, a 48-year-old non-profit professional from Maryland, has been taking the same medication for her lupus — and until recently, she never worried that her supply would run out. Now she’s terrified that she might lose access to a drug that prevents her immune system from attacking her heart, lungs, and skin. She describes a feeling akin to being underwater, near drowning: “That’s what my life would be like,” she said. “I’ll suffocate.”

Powers’ concerns began roughly a week ago when she learned that her lupus drug, hydroxychloroquine (hi-DROCK-see-KLORA-quin), may be helpful in the treatment of Covid-19, the illness caused by the SARS-CoV-2 virus now racing across the planet. The medication was already being used around world to treat Covid-19 patients, but evidence of its effectiveness was largely anecdotal. Then, on March 16, a renowned infectious disease specialist, Didier Raoult, announced the results of a small clinical trial in France showing that patients receiving a combination of hydroxychloroquine and the common antibiotic azithromycin had notably lower levels of the virus in their bloodstream than those who did not receive the medication.

In the last week, this once obscure drug has been thrust into the national spotlight with everyone from doctors, to laypeople, to the U.S. president weighing in. The attention has so dramatically driven up demand that pharmacists are reporting depleted stocks of the drug, leaving many of the roughly 1.5 million lupus patients across the country unable to get their prescriptions filled. They now face an uncertain future as the public clings to one of the first signs of hope to appear since the coronavirus began sweeping across the U.S.

But scientists and physicians caution that this hope is based on studies that have been conducted outside of traditional scientific timelines. “The paper is interesting and certainly would warrant future more definitive studies,” Jeff Sparks, a rheumatologist and researcher at Harvard Medical School, said of the French study. “It might even be enough data to use the regimen off-label for sick and hospitalized patients.

“However,” he added, “it does not prove that the regimen actually works.”

Despite efforts to pin blame for the shortages on Trump alone, however, hydroxychloroquine scarcity was already setting in weeks ago, as doctors began responding on their own to percolating and preliminary research. Some evidence suggests that many doctors are now writing prescriptions prophylactically for patients with no known illness — as well as for themselves and family members — prompting at least one state pharmacy board to call an emergency meeting, scheduled for Sunday morning. The board planned to bar pharmacists from dispensing chloroquine or hydroxychloroquine for anyone other than confirmed Covid-19 patients without approval of the board's director.

A prolonged shortfall in supplies would likely have grave implications for people who depend on it — including Powers, who believes that she would not be alive today without the drug. “I guarantee you, it has saved my life,” she said. “It’s the only thing that’s protecting my organs. There’s nothing else.” Like others, she hopes that pharmaceutical companies that manufacture versions of the drug will be able to quickly ramp up production — something several have already promised to do. In the meantime, Powers has a message for the American public — one echoed by most lupus doctors: When it comes to hydroxychloroquine: “If you don’t need it, don’t get it.”

The origins of hydroxychloroquine can be traced back hundreds of years to South America, where the bark of the cinchona tree appears to have been used by Andean populations to treat shivering. European missionaries eventually brought the bark to Europe, where it was used to treat malaria. In 1820, French researchers isolated the substance in the bark responsible for its beneficial effects. They named it “quinine.” When the supply from South America began to dry up, the British and Dutch decided to grow the tree on plantations.

Over time, synthetic versions were developed, including a drug called chloroquine, which was created in the midst of World War II in an effort to spare overseas American troops from malaria. As it turned out, troops with rashes and arthritis saw an improvement in symptoms after using this anti-malarial medication. After the war, a related drug was created, one with fewer side-effects when taken long-term: hydroxychloroquine. It went on to be used to treat many types of autoimmune diseases, including rheumatoid arthritis and lupus. The latter, which disproportionately affects women, used to cut lives short — typically from failure of the kidneys. Those numbers have been reduced with strict management of the disease, but the Lupus Foundation of America estimates that 10 to 15 percent of patients die prematurely due to complications of the disease.

For almost a quarter century, Julie Powers, a 48-year-old non-profit professional from Maryland, has been taking the same medication for her lupus — and until recently, she never worried that her supply would run out. Now she’s terrified that she might lose access to a drug that prevents her immune system from attacking her heart, lungs, and skin. She describes a feeling akin to being underwater, near drowning: “That’s what my life would be like,” she said. “I’ll suffocate.”

Powers’ concerns began roughly a week ago when she learned that her lupus drug, hydroxychloroquine (hi-DROCK-see-KLORA-quin), may be helpful in the treatment of Covid-19, the illness caused by the SARS-CoV-2 virus now racing across the planet. The medication was already being used around world to treat Covid-19 patients, but evidence of its effectiveness was largely anecdotal. Then, on March 16, a renowned infectious disease specialist, Didier Raoult, announced the results of a small clinical trial in France showing that patients receiving a combination of hydroxychloroquine and the common antibiotic azithromycin had notably lower levels of the virus in their bloodstream than those who did not receive the medication.

In the last week, this once obscure drug has been thrust into the national spotlight with everyone from doctors, to laypeople, to the U.S. president weighing in. The attention has so dramatically driven up demand that pharmacists are reporting depleted stocks of the drug, leaving many of the roughly 1.5 million lupus patients across the country unable to get their prescriptions filled. They now face an uncertain future as the public clings to one of the first signs of hope to appear since the coronavirus began sweeping across the U.S.

But scientists and physicians caution that this hope is based on studies that have been conducted outside of traditional scientific timelines. “The paper is interesting and certainly would warrant future more definitive studies,” Jeff Sparks, a rheumatologist and researcher at Harvard Medical School, said of the French study. “It might even be enough data to use the regimen off-label for sick and hospitalized patients.

“However,” he added, “it does not prove that the regimen actually works.”

Despite efforts to pin blame for the shortages on Trump alone, however, hydroxychloroquine scarcity was already setting in weeks ago, as doctors began responding on their own to percolating and preliminary research. Some evidence suggests that many doctors are now writing prescriptions prophylactically for patients with no known illness — as well as for themselves and family members — prompting at least one state pharmacy board to call an emergency meeting, scheduled for Sunday morning. The board planned to bar pharmacists from dispensing chloroquine or hydroxychloroquine for anyone other than confirmed Covid-19 patients without approval of the board's director.

A prolonged shortfall in supplies would likely have grave implications for people who depend on it — including Powers, who believes that she would not be alive today without the drug. “I guarantee you, it has saved my life,” she said. “It’s the only thing that’s protecting my organs. There’s nothing else.” Like others, she hopes that pharmaceutical companies that manufacture versions of the drug will be able to quickly ramp up production — something several have already promised to do. In the meantime, Powers has a message for the American public — one echoed by most lupus doctors: When it comes to hydroxychloroquine: “If you don’t need it, don’t get it.”

The origins of hydroxychloroquine can be traced back hundreds of years to South America, where the bark of the cinchona tree appears to have been used by Andean populations to treat shivering. European missionaries eventually brought the bark to Europe, where it was used to treat malaria. In 1820, French researchers isolated the substance in the bark responsible for its beneficial effects. They named it “quinine.” When the supply from South America began to dry up, the British and Dutch decided to grow the tree on plantations.

Over time, synthetic versions were developed, including a drug called chloroquine, which was created in the midst of World War II in an effort to spare overseas American troops from malaria. As it turned out, troops with rashes and arthritis saw an improvement in symptoms after using this anti-malarial medication. After the war, a related drug was created, one with fewer side-effects when taken long-term: hydroxychloroquine. It went on to be used to treat many types of autoimmune diseases, including rheumatoid arthritis and lupus. The latter, which disproportionately affects women, used to cut lives short — typically from failure of the kidneys. Those numbers have been reduced with strict management of the disease, but the Lupus Foundation of America estimates that 10 to 15 percent of patients die prematurely due to complications of the disease.

For almost a quarter century, Julie Powers, a 48-year-old non-profit professional from Maryland, has been taking the same medication for her lupus — and until recently, she never worried that her supply would run out. Now she’s terrified that she might lose access to a drug that prevents her immune system from attacking her heart, lungs, and skin. She describes a feeling akin to being underwater, near drowning: “That’s what my life would be like,” she said. “I’ll suffocate.”

Powers’ concerns began roughly a week ago when she learned that her lupus drug, hydroxychloroquine (hi-DROCK-see-KLORA-quin), may be helpful in the treatment of Covid-19, the illness caused by the SARS-CoV-2 virus now racing across the planet. The medication was already being used around world to treat Covid-19 patients, but evidence of its effectiveness was largely anecdotal. Then, on March 16, a renowned infectious disease specialist, Didier Raoult, announced the results of a small clinical trial in France showing that patients receiving a combination of hydroxychloroquine and the common antibiotic azithromycin had notably lower levels of the virus in their bloodstream than those who did not receive the medication.

In the last week, this once obscure drug has been thrust into the national spotlight with everyone from doctors, to laypeople, to the U.S. president weighing in. The attention has so dramatically driven up demand that pharmacists are reporting depleted stocks of the drug, leaving many of the roughly 1.5 million lupus patients across the country unable to get their prescriptions filled. They now face an uncertain future as the public clings to one of the first signs of hope to appear since the coronavirus began sweeping across the U.S.

But scientists and physicians caution that this hope is based on studies that have been conducted outside of traditional scientific timelines. “The paper is interesting and certainly would warrant future more definitive studies,” Jeff Sparks, a rheumatologist and researcher at Harvard Medical School, said of the French study. “It might even be enough data to use the regimen off-label for sick and hospitalized patients.

“However,” he added, “it does not prove that the regimen actually works.”

Despite efforts to pin blame for the shortages on Trump alone, however, hydroxychloroquine scarcity was already setting in weeks ago, as doctors began responding on their own to percolating and preliminary research. Some evidence suggests that many doctors are now writing prescriptions prophylactically for patients with no known illness — as well as for themselves and family members — prompting at least one state pharmacy board to call an emergency meeting, scheduled for Sunday morning. The board planned to bar pharmacists from dispensing chloroquine or hydroxychloroquine for anyone other than confirmed Covid-19 patients without approval of the board's director.

A prolonged shortfall in supplies would likely have grave implications for people who depend on it — including Powers, who believes that she would not be alive today without the drug. “I guarantee you, it has saved my life,” she said. “It’s the only thing that’s protecting my organs. There’s nothing else.” Like others, she hopes that pharmaceutical companies that manufacture versions of the drug will be able to quickly ramp up production — something several have already promised to do. In the meantime, Powers has a message for the American public — one echoed by most lupus doctors: When it comes to hydroxychloroquine: “If you don’t need it, don’t get it.”

The origins of hydroxychloroquine can be traced back hundreds of years to South America, where the bark of the cinchona tree appears to have been used by Andean populations to treat shivering. European missionaries eventually brought the bark to Europe, where it was used to treat malaria. In 1820, French researchers isolated the substance in the bark responsible for its beneficial effects. They named it “quinine.” When the supply from South America began to dry up, the British and Dutch decided to grow the tree on plantations.

Over time, synthetic versions were developed, including a drug called chloroquine, which was created in the midst of World War II in an effort to spare overseas American troops from malaria. As it turned out, troops with rashes and arthritis saw an improvement in symptoms after using this anti-malarial medication. After the war, a related drug was created, one with fewer side-effects when taken long-term: hydroxychloroquine. It went on to be used to treat many types of autoimmune diseases, including rheumatoid arthritis and lupus. The latter, which disproportionately affects women, used to cut lives short — typically from failure of the kidneys. Those numbers have been reduced with strict management of the disease, but the Lupus Foundation of America estimates that 10 to 15 percent of patients die prematurely due to complications of the disease.

In a webinar conducted on March 20, Leonard Valentino, MD, president and CEO of the National Hemophilia Foundation (NHF), provided specific information of relevance and some reassurance to the bleeding disorders community on the impact of COVID-19.

Overall, the risk of comorbidities is no different in the bleeding disorders population than in the general population, and similar precautions should be maintained, Dr. Valentino stated. He listed some of the at-risk populations as designated by the Centers for Disease Control and Prevention.

In particular, he pointed out that, when the CDC referred to a greater risk of COVID-19 to individuals with bleeding disorders, the organization was referring to patients with HIV and sickle cell disease. The CDC was not referring to patients with other forms of bleeding disorders, such as hemophilia, Dr. Valentino stated.

All individuals should be following CDC and state and federal recommendations with regard to social distancing and hygiene. However, with regard to immunocompromised individuals, “the two populations we [in the bleeding disorders community] have to be concerned about are those in gene therapy clinical trials and those with inhibitors,” said Dr. Valentino.

Patients in a gene therapy clinical trial should exercise additional precautions because the use of steroids, common in these trials. “Steroids are an immunosuppressive drug, and this would increase one’s risk of infection, including COVID-19,” according to Dr. Valentino.

In addition, “I will say, if you have hemophilia and an inhibitor [an antibody to clotting factor treatment], that may alter the immune system, and we don’t know what the implication of that is in terms of coronavirus infection and COVID-19 disease. So people with an inhibitor should take special precautions to limit their exposures.”

Patients with a port should not need to have extra concerns regarding COVID-19, but they should continue to exercise the good hygiene that has always been essential, according to Dr. Valentino.

Dr. Valentino asked: Are patients with a bleeding disorder who become infected with COVID-19 more susceptible to a bleed? “You shouldn’t be more susceptible to bleeding except if you have severe cough, and that cough could result in bleeding to the head,” he answered.

If a patient needs to go to the emergency department for a bleed or possible COVID-19 infection, they should wear a face mask if they are sick to prevent spreading of disease. “This is really the only instance where a face mask may be beneficial” in that it limits other people’s exposure to your infection. It is especially important to call ahead before visiting the doctor or going to the emergency department. “Make sure that they’re aware that you’re coming.”

Of particular concern to patients is the amount of factor product they should have on hand. The current CDC recommendation is a 30-day supply of medicines, but that is misleading, because it refers to general medications, such as high-blood pressure medicine, and not factor products. “The current MASAC [NHF’s Medical and Scientific Advisory Council] recommendation is to have a 14-day supply of factor products available to you,” said Dr. Valentino, “and one should reorder when you have a 1-week supply.”

MASAC has issued a letter on the crisis on the NHF website.

These recommendations should not be exceeded in order to ensure that there is enough factor available to all patients, he added. Hoarding is discouraged, and there are no concerns as yet of factor running out. “We have had conversations with manufacturers and … the supply chain is robust.” The greater concern is with regard to ancillary supplies in the hospital that a hemophilia patient may require during treatment.

Patients and practitioners should consult the COVID-19 pages of both the NHF and Hemophilia Federation of America (HFA) websites. This includes a Health and Wellness update by Dr. Valentino.

With regard to financial issues, he and Sharon Meyers, CEO and president of the HFA, spoke, stating that both NHF and HFA have advocacy for patients seeking to deal with insurance issues or in paying for their products, urging people to go to the organizational websites and to also use their emails: advocate@hemophilia.org and advocacy@hemophiliafed.org.

She also announced that the annual meeting of the HFA was being postponed to Aug. 24-26 at the Hilton Inner Harbor Baltimore, Md.

Dr. Valentino and Ms. Meyers did not provide any disclosure information.

mlesney@mededg.com

In a webinar conducted on March 20, Leonard Valentino, MD, president and CEO of the National Hemophilia Foundation (NHF), provided specific information of relevance and some reassurance to the bleeding disorders community on the impact of COVID-19.

Overall, the risk of comorbidities is no different in the bleeding disorders population than in the general population, and similar precautions should be maintained, Dr. Valentino stated. He listed some of the at-risk populations as designated by the Centers for Disease Control and Prevention.

In particular, he pointed out that, when the CDC referred to a greater risk of COVID-19 to individuals with bleeding disorders, the organization was referring to patients with HIV and sickle cell disease. The CDC was not referring to patients with other forms of bleeding disorders, such as hemophilia, Dr. Valentino stated.

All individuals should be following CDC and state and federal recommendations with regard to social distancing and hygiene. However, with regard to immunocompromised individuals, “the two populations we [in the bleeding disorders community] have to be concerned about are those in gene therapy clinical trials and those with inhibitors,” said Dr. Valentino.

Patients in a gene therapy clinical trial should exercise additional precautions because the use of steroids, common in these trials. “Steroids are an immunosuppressive drug, and this would increase one’s risk of infection, including COVID-19,” according to Dr. Valentino.

In addition, “I will say, if you have hemophilia and an inhibitor [an antibody to clotting factor treatment], that may alter the immune system, and we don’t know what the implication of that is in terms of coronavirus infection and COVID-19 disease. So people with an inhibitor should take special precautions to limit their exposures.”

Patients with a port should not need to have extra concerns regarding COVID-19, but they should continue to exercise the good hygiene that has always been essential, according to Dr. Valentino.

Dr. Valentino asked: Are patients with a bleeding disorder who become infected with COVID-19 more susceptible to a bleed? “You shouldn’t be more susceptible to bleeding except if you have severe cough, and that cough could result in bleeding to the head,” he answered.

If a patient needs to go to the emergency department for a bleed or possible COVID-19 infection, they should wear a face mask if they are sick to prevent spreading of disease. “This is really the only instance where a face mask may be beneficial” in that it limits other people’s exposure to your infection. It is especially important to call ahead before visiting the doctor or going to the emergency department. “Make sure that they’re aware that you’re coming.”

Of particular concern to patients is the amount of factor product they should have on hand. The current CDC recommendation is a 30-day supply of medicines, but that is misleading, because it refers to general medications, such as high-blood pressure medicine, and not factor products. “The current MASAC [NHF’s Medical and Scientific Advisory Council] recommendation is to have a 14-day supply of factor products available to you,” said Dr. Valentino, “and one should reorder when you have a 1-week supply.”

MASAC has issued a letter on the crisis on the NHF website.

These recommendations should not be exceeded in order to ensure that there is enough factor available to all patients, he added. Hoarding is discouraged, and there are no concerns as yet of factor running out. “We have had conversations with manufacturers and … the supply chain is robust.” The greater concern is with regard to ancillary supplies in the hospital that a hemophilia patient may require during treatment.

Patients and practitioners should consult the COVID-19 pages of both the NHF and Hemophilia Federation of America (HFA) websites. This includes a Health and Wellness update by Dr. Valentino.

With regard to financial issues, he and Sharon Meyers, CEO and president of the HFA, spoke, stating that both NHF and HFA have advocacy for patients seeking to deal with insurance issues or in paying for their products, urging people to go to the organizational websites and to also use their emails: advocate@hemophilia.org and advocacy@hemophiliafed.org.

She also announced that the annual meeting of the HFA was being postponed to Aug. 24-26 at the Hilton Inner Harbor Baltimore, Md.

Dr. Valentino and Ms. Meyers did not provide any disclosure information.

mlesney@mededg.com

In a webinar conducted on March 20, Leonard Valentino, MD, president and CEO of the National Hemophilia Foundation (NHF), provided specific information of relevance and some reassurance to the bleeding disorders community on the impact of COVID-19.

Overall, the risk of comorbidities is no different in the bleeding disorders population than in the general population, and similar precautions should be maintained, Dr. Valentino stated. He listed some of the at-risk populations as designated by the Centers for Disease Control and Prevention.

In particular, he pointed out that, when the CDC referred to a greater risk of COVID-19 to individuals with bleeding disorders, the organization was referring to patients with HIV and sickle cell disease. The CDC was not referring to patients with other forms of bleeding disorders, such as hemophilia, Dr. Valentino stated.

All individuals should be following CDC and state and federal recommendations with regard to social distancing and hygiene. However, with regard to immunocompromised individuals, “the two populations we [in the bleeding disorders community] have to be concerned about are those in gene therapy clinical trials and those with inhibitors,” said Dr. Valentino.

Patients in a gene therapy clinical trial should exercise additional precautions because the use of steroids, common in these trials. “Steroids are an immunosuppressive drug, and this would increase one’s risk of infection, including COVID-19,” according to Dr. Valentino.

In addition, “I will say, if you have hemophilia and an inhibitor [an antibody to clotting factor treatment], that may alter the immune system, and we don’t know what the implication of that is in terms of coronavirus infection and COVID-19 disease. So people with an inhibitor should take special precautions to limit their exposures.”

Patients with a port should not need to have extra concerns regarding COVID-19, but they should continue to exercise the good hygiene that has always been essential, according to Dr. Valentino.

Dr. Valentino asked: Are patients with a bleeding disorder who become infected with COVID-19 more susceptible to a bleed? “You shouldn’t be more susceptible to bleeding except if you have severe cough, and that cough could result in bleeding to the head,” he answered.

If a patient needs to go to the emergency department for a bleed or possible COVID-19 infection, they should wear a face mask if they are sick to prevent spreading of disease. “This is really the only instance where a face mask may be beneficial” in that it limits other people’s exposure to your infection. It is especially important to call ahead before visiting the doctor or going to the emergency department. “Make sure that they’re aware that you’re coming.”

Of particular concern to patients is the amount of factor product they should have on hand. The current CDC recommendation is a 30-day supply of medicines, but that is misleading, because it refers to general medications, such as high-blood pressure medicine, and not factor products. “The current MASAC [NHF’s Medical and Scientific Advisory Council] recommendation is to have a 14-day supply of factor products available to you,” said Dr. Valentino, “and one should reorder when you have a 1-week supply.”

MASAC has issued a letter on the crisis on the NHF website.

These recommendations should not be exceeded in order to ensure that there is enough factor available to all patients, he added. Hoarding is discouraged, and there are no concerns as yet of factor running out. “We have had conversations with manufacturers and … the supply chain is robust.” The greater concern is with regard to ancillary supplies in the hospital that a hemophilia patient may require during treatment.

Patients and practitioners should consult the COVID-19 pages of both the NHF and Hemophilia Federation of America (HFA) websites. This includes a Health and Wellness update by Dr. Valentino.

With regard to financial issues, he and Sharon Meyers, CEO and president of the HFA, spoke, stating that both NHF and HFA have advocacy for patients seeking to deal with insurance issues or in paying for their products, urging people to go to the organizational websites and to also use their emails: advocate@hemophilia.org and advocacy@hemophiliafed.org.

She also announced that the annual meeting of the HFA was being postponed to Aug. 24-26 at the Hilton Inner Harbor Baltimore, Md.

Dr. Valentino and Ms. Meyers did not provide any disclosure information.

mlesney@mededg.com

Click to read.

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that affects approximately 10% of US children. Colloidal oatmeal has long been used as a topical treatment for AD and modern research confirms the benefits of colloidal oatmeal formulations to significantly improve symptoms. Click to learn more about colloidal oatmeal in combination with oat flour and oat extract as effective and well-tolerated skin-directed therapy for your young AD patients. 

Click to read. 

About the Author

Click to read.

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that affects approximately 10% of US children. Colloidal oatmeal has long been used as a topical treatment for AD and modern research confirms the benefits of colloidal oatmeal formulations to significantly improve symptoms. Click to learn more about colloidal oatmeal in combination with oat flour and oat extract as effective and well-tolerated skin-directed therapy for your young AD patients. 

Click to read. 

About the Author

Click to read.

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that affects approximately 10% of US children. Colloidal oatmeal has long been used as a topical treatment for AD and modern research confirms the benefits of colloidal oatmeal formulations to significantly improve symptoms. Click to learn more about colloidal oatmeal in combination with oat flour and oat extract as effective and well-tolerated skin-directed therapy for your young AD patients. 

Click to read. 

About the Author

Gastroenterologists and other clinicians caring for patients with inflammatory bowel disease are being encouraged to report outcomes for pediatric and adult patients with IBD and COVID-19 infections to a new international registry.

The Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry is a repository for data on all cases of COVID-19 in patients with IBD, including those who are asymptomatic and detected only through public health screening.

The idea for the registry came from gastroenterologists at the University of North Carolina at Chapel Hill and at the Icahn School of Medicine at Mount Sinai, New York.

It was developed out of the recognition that, “with the emergence of this international health crisis, it would make sense to develop a registry to allow clinicians taking care of patients with inflammatory bowel disease to report on the specifics of their cases, so that we could then quickly define what the impact is of this disease on our patients, and determine how disease severity, medication, and specific demographics impact COVID-related outcomes in our population,” said registry cofounder Erica Brenner, MD, a pediatric gastroenterology fellow at UNC.

As of March 19, 2020, 14 cases of COVID-19 infections in patients with IBD had been reported to the registry: 6 from the United States, 3 from Spain, and 1 each from the United Kingdom, Switzerland, Ireland, Italy and the Netherlands. There were no patient deaths, and only two required hospitalization. Neither of the hospitalized patients required intensive care or ventilator support.

Dr. Brenner noted that it’s still early days, and that a clearer picture of the pandemic will begin to emerge as more cases are reported.

“We are planning at least weekly to update our ‘Updates and Data’ tab on the registry with summary data and aggregate information,” she said in an interview.

All data in the registry are deidentified in accordance with HIPAA Safe Harbor standards. The UNC–Chapel Hill Office for Human Research Ethics has determined that storage and analysis of deidentified data is exempt from institutional review board requirement because it does not constitute human subjects research as defined under federal regulations.

SECURE-IBD was the inspiration for a similarly designed COVID-19 registry for clinicians who treat patients with rheumatologic disorders, who often are treated with immunosuppressive agents familiar to the rheumatology community, such as infliximab (Remicade and biosimilars), adalimumab (Humira and biosimilars), and methotrexate.

“We’re in the process of talking to different leaders across specialties to leverage our blueprint to implement registries in all sorts of disease states, including cirrhosis, psoriasis, lupus, and sickle cell disease,” Dr. Brenner said.

The data entry process is estimated to take 5 minutes. Participating clinicians are requested to reported on confirmed COVID-19 cases only “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

“The success of this registry depends on international collaboration and buy-in from clinicians around the world, so we really encourage all clinicians who take care of patients with inflammatory bowel disease to go to our website and report a case,” Dr. Brenner said.

Gastroenterologists and other clinicians caring for patients with inflammatory bowel disease are being encouraged to report outcomes for pediatric and adult patients with IBD and COVID-19 infections to a new international registry.

The Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry is a repository for data on all cases of COVID-19 in patients with IBD, including those who are asymptomatic and detected only through public health screening.

The idea for the registry came from gastroenterologists at the University of North Carolina at Chapel Hill and at the Icahn School of Medicine at Mount Sinai, New York.

It was developed out of the recognition that, “with the emergence of this international health crisis, it would make sense to develop a registry to allow clinicians taking care of patients with inflammatory bowel disease to report on the specifics of their cases, so that we could then quickly define what the impact is of this disease on our patients, and determine how disease severity, medication, and specific demographics impact COVID-related outcomes in our population,” said registry cofounder Erica Brenner, MD, a pediatric gastroenterology fellow at UNC.

As of March 19, 2020, 14 cases of COVID-19 infections in patients with IBD had been reported to the registry: 6 from the United States, 3 from Spain, and 1 each from the United Kingdom, Switzerland, Ireland, Italy and the Netherlands. There were no patient deaths, and only two required hospitalization. Neither of the hospitalized patients required intensive care or ventilator support.

Dr. Brenner noted that it’s still early days, and that a clearer picture of the pandemic will begin to emerge as more cases are reported.

“We are planning at least weekly to update our ‘Updates and Data’ tab on the registry with summary data and aggregate information,” she said in an interview.

All data in the registry are deidentified in accordance with HIPAA Safe Harbor standards. The UNC–Chapel Hill Office for Human Research Ethics has determined that storage and analysis of deidentified data is exempt from institutional review board requirement because it does not constitute human subjects research as defined under federal regulations.

SECURE-IBD was the inspiration for a similarly designed COVID-19 registry for clinicians who treat patients with rheumatologic disorders, who often are treated with immunosuppressive agents familiar to the rheumatology community, such as infliximab (Remicade and biosimilars), adalimumab (Humira and biosimilars), and methotrexate.

“We’re in the process of talking to different leaders across specialties to leverage our blueprint to implement registries in all sorts of disease states, including cirrhosis, psoriasis, lupus, and sickle cell disease,” Dr. Brenner said.

The data entry process is estimated to take 5 minutes. Participating clinicians are requested to reported on confirmed COVID-19 cases only “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

“The success of this registry depends on international collaboration and buy-in from clinicians around the world, so we really encourage all clinicians who take care of patients with inflammatory bowel disease to go to our website and report a case,” Dr. Brenner said.

Gastroenterologists and other clinicians caring for patients with inflammatory bowel disease are being encouraged to report outcomes for pediatric and adult patients with IBD and COVID-19 infections to a new international registry.

The Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry is a repository for data on all cases of COVID-19 in patients with IBD, including those who are asymptomatic and detected only through public health screening.

The idea for the registry came from gastroenterologists at the University of North Carolina at Chapel Hill and at the Icahn School of Medicine at Mount Sinai, New York.

It was developed out of the recognition that, “with the emergence of this international health crisis, it would make sense to develop a registry to allow clinicians taking care of patients with inflammatory bowel disease to report on the specifics of their cases, so that we could then quickly define what the impact is of this disease on our patients, and determine how disease severity, medication, and specific demographics impact COVID-related outcomes in our population,” said registry cofounder Erica Brenner, MD, a pediatric gastroenterology fellow at UNC.

As of March 19, 2020, 14 cases of COVID-19 infections in patients with IBD had been reported to the registry: 6 from the United States, 3 from Spain, and 1 each from the United Kingdom, Switzerland, Ireland, Italy and the Netherlands. There were no patient deaths, and only two required hospitalization. Neither of the hospitalized patients required intensive care or ventilator support.

Dr. Brenner noted that it’s still early days, and that a clearer picture of the pandemic will begin to emerge as more cases are reported.

“We are planning at least weekly to update our ‘Updates and Data’ tab on the registry with summary data and aggregate information,” she said in an interview.

All data in the registry are deidentified in accordance with HIPAA Safe Harbor standards. The UNC–Chapel Hill Office for Human Research Ethics has determined that storage and analysis of deidentified data is exempt from institutional review board requirement because it does not constitute human subjects research as defined under federal regulations.

SECURE-IBD was the inspiration for a similarly designed COVID-19 registry for clinicians who treat patients with rheumatologic disorders, who often are treated with immunosuppressive agents familiar to the rheumatology community, such as infliximab (Remicade and biosimilars), adalimumab (Humira and biosimilars), and methotrexate.

“We’re in the process of talking to different leaders across specialties to leverage our blueprint to implement registries in all sorts of disease states, including cirrhosis, psoriasis, lupus, and sickle cell disease,” Dr. Brenner said.

The data entry process is estimated to take 5 minutes. Participating clinicians are requested to reported on confirmed COVID-19 cases only “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

“The success of this registry depends on international collaboration and buy-in from clinicians around the world, so we really encourage all clinicians who take care of patients with inflammatory bowel disease to go to our website and report a case,” Dr. Brenner said.

Researchers have hypothesized that treatments that increase angiotensin-converting enzyme 2 (ACE2) may also increase the risk of novel coronavirus disease (COVID-19). This speculation and other concerns have led some officials and organizations to question whether ibuprofen or other drugs such as renin angiotensin aldosterone system (RAAS) antagonists should be avoided as treatments in patients with COVID-19. Health agencies and professional organizations have said they are not recommending against these medications.

The Food and Drug Administration on March 19 advised patients that it was “not aware of scientific evidence connecting” nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen “with worsening COVID-19 symptoms.”

“The agency is investigating this issue further and will communicate publicly when more information is available,” the FDA said. “However, all prescription NSAID labels warn that ‘the pharmacological activity of NSAIDs in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.’ ” The FDA also noted that other over-the-counter and prescription medications are available for pain relief and fever reduction, and patients who “are concerned about taking NSAIDs and rely on these medications to treat chronic diseases” should talk to a health care provider.

A World Health Organization spokesperson said during a press conference on March 17 that the organization was looking into concerns about ibuprofen use in patients with COVID-19 and suggested that in the meantime patients take acetaminophen for fever instead. On March 18, the WHO said that it was not recommending against the use of ibuprofen.

“At present, based on currently available information, WHO does not recommend against the use of ibuprofen,” the organization said. “We are also consulting with physicians treating COVID-19 patients and are not aware of reports of any negative effects of ibuprofen, beyond the usual known side effects that limit its use in certain populations. WHO is not aware of published clinical or population-based data on this topic.”

A spokesperson for the National Institute of Allergy and Infectious Diseases said on March 18, “More research is needed to evaluate reports that ibruprofen and other over-the-counter anti-inflammatory drugs may affect the course of COVID-19. Currently, there is no conclusive evidence that ibuprofen and other over-the-counter anti-inflammatory drugs increase the risk of serious complications or of acquiring the virus that causes COVID-19. There is also no conclusive evidence that taking over-the-counter anti-inflammatory drugs is harmful for other respiratory infections.”

The European Medicines Agency (EMA) on March 18 said, “There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.”

In correspondence published March 11 in the Lancet Respiratory Medicine, Lei Fang, MD, of the department of biomedicine at University Hospital Basel (Switzerland), and colleagues suggested that patients with hypertension and diabetes mellitus may be at increased risk of COVID-19 because these comorbidities “are often treated with angiotensin converting enzyme (ACE) inhibitors.” In addition, “ACE2 polymorphisms that have been linked to diabetes mellitus, cerebral stroke, and hypertension” also may play a role, the researchers said (Lancet Respir Med. 2020 Mar 11. https://doi.org/10.1016/S2213-2600(20)30116-8).

“ACE2 is substantially increased in patients with type 1 or type 2 diabetes, who are treated with ACE inhibitors and angiotensin II type-I receptor blockers (ARBs). Hypertension is also treated with ACE inhibitors and ARBs, which results in an upregulation of ACE2. ACE2 can also be increased by thiazolidinediones and ibuprofen.”

A March 16 statement from the Heart Failure Society of America (HSFC), American College of Cardiology (ACC), and American Heart Association (AHA) addressed concerns about using RAAS antagonists in COVID-19.

“Patients with underlying cardiovascular diseases appear to have an increased risk for adverse outcomes with [COVID-19],” the organizations said. “Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients also may have severe cardiovascular damage. [ACE2] receptors have been shown to be the entry point into human cells for SARS-CoV-2, the virus that causes COVID-19. In a few experimental studies with animal models, both [ACE] inhibitors and angiotensin receptor blockers (ARBs) have been shown to upregulate ACE2 expression in the heart. Though these have not been shown in human studies, or in the setting of COVID-19, such potential upregulation of ACE2 by ACE inhibitors or ARBs has resulted in a speculation of potential increased risk for COVID-19 infection in patients with background treatment of these medications.”

ACE2, ACE, angiotensin II, and other RAAS system interactions “are quite complex, and at times, paradoxical,” the statement says. “In experimental studies, both ACE inhibitors and ARBs have been shown to reduce severe lung injury in certain viral pneumonias, and it has been speculated that these agents could be beneficial in COVID-19.

“Currently there are no experimental or clinical data demonstrating beneficial or adverse outcomes with background use of ACE inhibitors, ARBs or other RAAS antagonists in COVID-19 or among COVID-19 patients with a history of cardiovascular disease treated with such agents. The HFSA, ACC, and AHA recommend continuation of RAAS antagonists for those patients who are currently prescribed such agents for indications for which these agents are known to be beneficial, such as heart failure, hypertension, or ischemic heart disease. In the event patients with cardiovascular disease are diagnosed with COVID-19, individualized treatment decisions should be made according to each patient’s hemodynamic status and clinical presentation. Therefore, be advised not to add or remove any RAAS-related treatments, beyond actions based on standard clinical practice.

“These theoretical concerns and findings of cardiovascular involvement with COVID-19 deserve much more detailed research, and quickly. As further research and developments related to this issue evolve, we will update these recommendations as needed.”

Dr. Fang and colleagues had no competing interests.
 

jremaly@mdedge.com

SOURCE: Fang L et al. Lancet Respir Med. 2020 Mar 11. doi: 10.1016/S2213-2600(20)30116-8.

Researchers have hypothesized that treatments that increase angiotensin-converting enzyme 2 (ACE2) may also increase the risk of novel coronavirus disease (COVID-19). This speculation and other concerns have led some officials and organizations to question whether ibuprofen or other drugs such as renin angiotensin aldosterone system (RAAS) antagonists should be avoided as treatments in patients with COVID-19. Health agencies and professional organizations have said they are not recommending against these medications.

The Food and Drug Administration on March 19 advised patients that it was “not aware of scientific evidence connecting” nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen “with worsening COVID-19 symptoms.”

“The agency is investigating this issue further and will communicate publicly when more information is available,” the FDA said. “However, all prescription NSAID labels warn that ‘the pharmacological activity of NSAIDs in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.’ ” The FDA also noted that other over-the-counter and prescription medications are available for pain relief and fever reduction, and patients who “are concerned about taking NSAIDs and rely on these medications to treat chronic diseases” should talk to a health care provider.

A World Health Organization spokesperson said during a press conference on March 17 that the organization was looking into concerns about ibuprofen use in patients with COVID-19 and suggested that in the meantime patients take acetaminophen for fever instead. On March 18, the WHO said that it was not recommending against the use of ibuprofen.

“At present, based on currently available information, WHO does not recommend against the use of ibuprofen,” the organization said. “We are also consulting with physicians treating COVID-19 patients and are not aware of reports of any negative effects of ibuprofen, beyond the usual known side effects that limit its use in certain populations. WHO is not aware of published clinical or population-based data on this topic.”

A spokesperson for the National Institute of Allergy and Infectious Diseases said on March 18, “More research is needed to evaluate reports that ibruprofen and other over-the-counter anti-inflammatory drugs may affect the course of COVID-19. Currently, there is no conclusive evidence that ibuprofen and other over-the-counter anti-inflammatory drugs increase the risk of serious complications or of acquiring the virus that causes COVID-19. There is also no conclusive evidence that taking over-the-counter anti-inflammatory drugs is harmful for other respiratory infections.”

The European Medicines Agency (EMA) on March 18 said, “There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.”

In correspondence published March 11 in the Lancet Respiratory Medicine, Lei Fang, MD, of the department of biomedicine at University Hospital Basel (Switzerland), and colleagues suggested that patients with hypertension and diabetes mellitus may be at increased risk of COVID-19 because these comorbidities “are often treated with angiotensin converting enzyme (ACE) inhibitors.” In addition, “ACE2 polymorphisms that have been linked to diabetes mellitus, cerebral stroke, and hypertension” also may play a role, the researchers said (Lancet Respir Med. 2020 Mar 11. https://doi.org/10.1016/S2213-2600(20)30116-8).

“ACE2 is substantially increased in patients with type 1 or type 2 diabetes, who are treated with ACE inhibitors and angiotensin II type-I receptor blockers (ARBs). Hypertension is also treated with ACE inhibitors and ARBs, which results in an upregulation of ACE2. ACE2 can also be increased by thiazolidinediones and ibuprofen.”

A March 16 statement from the Heart Failure Society of America (HSFC), American College of Cardiology (ACC), and American Heart Association (AHA) addressed concerns about using RAAS antagonists in COVID-19.

“Patients with underlying cardiovascular diseases appear to have an increased risk for adverse outcomes with [COVID-19],” the organizations said. “Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients also may have severe cardiovascular damage. [ACE2] receptors have been shown to be the entry point into human cells for SARS-CoV-2, the virus that causes COVID-19. In a few experimental studies with animal models, both [ACE] inhibitors and angiotensin receptor blockers (ARBs) have been shown to upregulate ACE2 expression in the heart. Though these have not been shown in human studies, or in the setting of COVID-19, such potential upregulation of ACE2 by ACE inhibitors or ARBs has resulted in a speculation of potential increased risk for COVID-19 infection in patients with background treatment of these medications.”

ACE2, ACE, angiotensin II, and other RAAS system interactions “are quite complex, and at times, paradoxical,” the statement says. “In experimental studies, both ACE inhibitors and ARBs have been shown to reduce severe lung injury in certain viral pneumonias, and it has been speculated that these agents could be beneficial in COVID-19.

“Currently there are no experimental or clinical data demonstrating beneficial or adverse outcomes with background use of ACE inhibitors, ARBs or other RAAS antagonists in COVID-19 or among COVID-19 patients with a history of cardiovascular disease treated with such agents. The HFSA, ACC, and AHA recommend continuation of RAAS antagonists for those patients who are currently prescribed such agents for indications for which these agents are known to be beneficial, such as heart failure, hypertension, or ischemic heart disease. In the event patients with cardiovascular disease are diagnosed with COVID-19, individualized treatment decisions should be made according to each patient’s hemodynamic status and clinical presentation. Therefore, be advised not to add or remove any RAAS-related treatments, beyond actions based on standard clinical practice.

“These theoretical concerns and findings of cardiovascular involvement with COVID-19 deserve much more detailed research, and quickly. As further research and developments related to this issue evolve, we will update these recommendations as needed.”

Dr. Fang and colleagues had no competing interests.
 

jremaly@mdedge.com

SOURCE: Fang L et al. Lancet Respir Med. 2020 Mar 11. doi: 10.1016/S2213-2600(20)30116-8.

Researchers have hypothesized that treatments that increase angiotensin-converting enzyme 2 (ACE2) may also increase the risk of novel coronavirus disease (COVID-19). This speculation and other concerns have led some officials and organizations to question whether ibuprofen or other drugs such as renin angiotensin aldosterone system (RAAS) antagonists should be avoided as treatments in patients with COVID-19. Health agencies and professional organizations have said they are not recommending against these medications.

The Food and Drug Administration on March 19 advised patients that it was “not aware of scientific evidence connecting” nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen “with worsening COVID-19 symptoms.”

“The agency is investigating this issue further and will communicate publicly when more information is available,” the FDA said. “However, all prescription NSAID labels warn that ‘the pharmacological activity of NSAIDs in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.’ ” The FDA also noted that other over-the-counter and prescription medications are available for pain relief and fever reduction, and patients who “are concerned about taking NSAIDs and rely on these medications to treat chronic diseases” should talk to a health care provider.

A World Health Organization spokesperson said during a press conference on March 17 that the organization was looking into concerns about ibuprofen use in patients with COVID-19 and suggested that in the meantime patients take acetaminophen for fever instead. On March 18, the WHO said that it was not recommending against the use of ibuprofen.

“At present, based on currently available information, WHO does not recommend against the use of ibuprofen,” the organization said. “We are also consulting with physicians treating COVID-19 patients and are not aware of reports of any negative effects of ibuprofen, beyond the usual known side effects that limit its use in certain populations. WHO is not aware of published clinical or population-based data on this topic.”

A spokesperson for the National Institute of Allergy and Infectious Diseases said on March 18, “More research is needed to evaluate reports that ibruprofen and other over-the-counter anti-inflammatory drugs may affect the course of COVID-19. Currently, there is no conclusive evidence that ibuprofen and other over-the-counter anti-inflammatory drugs increase the risk of serious complications or of acquiring the virus that causes COVID-19. There is also no conclusive evidence that taking over-the-counter anti-inflammatory drugs is harmful for other respiratory infections.”

The European Medicines Agency (EMA) on March 18 said, “There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.”

In correspondence published March 11 in the Lancet Respiratory Medicine, Lei Fang, MD, of the department of biomedicine at University Hospital Basel (Switzerland), and colleagues suggested that patients with hypertension and diabetes mellitus may be at increased risk of COVID-19 because these comorbidities “are often treated with angiotensin converting enzyme (ACE) inhibitors.” In addition, “ACE2 polymorphisms that have been linked to diabetes mellitus, cerebral stroke, and hypertension” also may play a role, the researchers said (Lancet Respir Med. 2020 Mar 11. https://doi.org/10.1016/S2213-2600(20)30116-8).

“ACE2 is substantially increased in patients with type 1 or type 2 diabetes, who are treated with ACE inhibitors and angiotensin II type-I receptor blockers (ARBs). Hypertension is also treated with ACE inhibitors and ARBs, which results in an upregulation of ACE2. ACE2 can also be increased by thiazolidinediones and ibuprofen.”

A March 16 statement from the Heart Failure Society of America (HSFC), American College of Cardiology (ACC), and American Heart Association (AHA) addressed concerns about using RAAS antagonists in COVID-19.

“Patients with underlying cardiovascular diseases appear to have an increased risk for adverse outcomes with [COVID-19],” the organizations said. “Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients also may have severe cardiovascular damage. [ACE2] receptors have been shown to be the entry point into human cells for SARS-CoV-2, the virus that causes COVID-19. In a few experimental studies with animal models, both [ACE] inhibitors and angiotensin receptor blockers (ARBs) have been shown to upregulate ACE2 expression in the heart. Though these have not been shown in human studies, or in the setting of COVID-19, such potential upregulation of ACE2 by ACE inhibitors or ARBs has resulted in a speculation of potential increased risk for COVID-19 infection in patients with background treatment of these medications.”

ACE2, ACE, angiotensin II, and other RAAS system interactions “are quite complex, and at times, paradoxical,” the statement says. “In experimental studies, both ACE inhibitors and ARBs have been shown to reduce severe lung injury in certain viral pneumonias, and it has been speculated that these agents could be beneficial in COVID-19.

“Currently there are no experimental or clinical data demonstrating beneficial or adverse outcomes with background use of ACE inhibitors, ARBs or other RAAS antagonists in COVID-19 or among COVID-19 patients with a history of cardiovascular disease treated with such agents. The HFSA, ACC, and AHA recommend continuation of RAAS antagonists for those patients who are currently prescribed such agents for indications for which these agents are known to be beneficial, such as heart failure, hypertension, or ischemic heart disease. In the event patients with cardiovascular disease are diagnosed with COVID-19, individualized treatment decisions should be made according to each patient’s hemodynamic status and clinical presentation. Therefore, be advised not to add or remove any RAAS-related treatments, beyond actions based on standard clinical practice.

“These theoretical concerns and findings of cardiovascular involvement with COVID-19 deserve much more detailed research, and quickly. As further research and developments related to this issue evolve, we will update these recommendations as needed.”

Dr. Fang and colleagues had no competing interests.
 

jremaly@mdedge.com

SOURCE: Fang L et al. Lancet Respir Med. 2020 Mar 11. doi: 10.1016/S2213-2600(20)30116-8.