From the Editor

As the life-altering coronavirus disease 2019 (COVID-19) pandemic gradually ebbs, we are all its survivors. Now, we are experiencing COVID-19 fatigue, trying to emerge from its dense fog that pervaded every facet of our lives. We are fully cognizant that there will not be a return to the previous “normal.” The pernicious virus had a transformative effect that did not spare any component of our society. Full recovery will not be easy.

As the uncertainty lingers about another devastating return of the pandemic later this year, we can see the reverberation of this invisible assault on human existence. Although a relatively small fraction of the population lost their lives, the rest of us are valiantly trying to readjust to the multiple ways our world has changed. Consider the following abrupt and sweeping burdens inflicted by the pandemic within a few short weeks:

Mental health. The acute stress of thanatophobia generated a triad of anxiety, depression, and nosophobia on a large scale. The demand for psychiatric care rapidly escalated. Suicide rate increased not only because of the stress of being locked down at home (alien to most people’s lifestyle) but because of the coincidental timing of the pandemic during April and May, the peak time of year for suicide. Animal researchers use immobilization as a paradigm to stress a rat or mouse. Many humans immobilized during the pandemic have developed exquisite empathy towards those rodents! The impact on children may also have long-term effects because playing and socializing with friends is a vital part of their lives. Parents have noticed dysphoria and acting out among their children, and an intense compensatory preoccupation with video games and electronic communications with friends.

Physical health. Medical care focused heavily on COVID-19 victims, to the detriment of all other medical conditions. Non-COVID-19 hospital admissions plummeted, and all elective surgeries and procedures were put on hold, depriving many people of medical care they badly needed. Emergency department (ED) visits also declined dramatically, including the usual flow of heart attacks, stroke, pulmonary embolus, asthma attacks, etc. The minimization of driving greatly reduced the admission of accident victims to EDs. Colonoscopies, cardiac stents, hip replacements, MRIs, mammography, and other procedures that are vital to maintain health and quality of life were halted. Dentists shuttered their practices due to the high risk of infection from exposure to oral secretions and breathing. One can only imagine the suffering of having a toothache with no dental help available, and how that might lead to narcotic abuse.

Social health. The imperative of social distancing disrupted most ordinary human activities, such as dining out, sitting in an auditorium for Grand Rounds or a lecture, visiting friends at their homes, the cherished interactions between grandparents and grandchildren (the lack of which I painfully experienced), and even seeing each other’s smiles behind the ubiquitous masks. And forget about hugging or kissing. The aversion to being near anyone who is coughing or sneezing led to an adaptive social paranoia and the social shunning of anyone who appeared to have an upper respiratory infection, even if it was unrelated to COVID-19.

Redemption for the pharmaceutical industry. The deadly pandemic intensified the public’s awareness of the importance of developing treatments and vaccines for COVID-19. The often-demonized pharmaceutical companies, with their extensive R&D infrastructure, emerged as a major source of hope for discovering an effective treatment for the coronavirus infection, or—better still—one or more vaccines that will enable society to return to its normal functions. It was quite impressive how many pharmaceutical companies “came to the rescue” with clinical trials to repurpose existing medications or to develop new ones. It was very encouraging to see multiple vaccine candidates being developed and expedited for testing around the world. A process that usually takes years was reduced to a few months, thanks to the existing technical infrastructure and thousands of scientists who enable rapid drug development. It is possible that the public may gradually modify its perception of the pharmaceutical industry from a “corporate villain” to an “indispensable health industry” for urgent medical crises such as a pandemic, and also for hundreds of medical diseases that are still in need of safe, effective therapies.

Economic burden. The unimaginable nightmare scenario of a total shutdown of all businesses led to the unprecedented loss of millions of jobs and livelihoods, reflected in miles-long lines of families at food banks. Overnight, the government switched from worrying about its $20-trillion deficit to printing several more trillion dollars to rescue the economy from collapse. The huge magnitude of a trillion can be appreciated if one is aware that it takes roughly 32 years to count to 1 billion, and 32,000 years to count to 1 trillion. Stimulating the economy while the gross domestic product threatens to sink by terrifying percentages (20% to 30%) was urgently needed, even though it meant mortgaging the future, especially when interest rates, and servicing the debt, will inevitably rise from the current zero to much higher levels in the future. The collapse of the once-thriving airline industry (bookings were down an estimated 98%) is an example of why desperate measures were needed to salvage an economy paralyzed by a viral pandemic.

Continue to: Political repercussions

Political repercussions. In our already hyperpartisan country, the COVID-19 crisis created more fissures across party lines. The blame game escalated as each side tried to exploit the crisis for political gain during a presidential election year. None of the leaders, from mayors to governors to the president, had any notion of how to wisely manage an unforeseen catastrophic pandemic. Thus, a political cacophony has developed, further exacerbating the public’s anxiety and uncertainty, especially about how and when the pandemic will end.

Education disruption. Never before have all schools and colleges around the country abruptly closed and sent students of all ages to shelter at home. Massive havoc ensued, with a wholesale switch to solitary online learning, the loss of the unique school and college social experience in the classroom and on campus, and the loss of experiencing commencement to receive a diploma (an important milestone for every graduate). Even medical students were not allowed to complete their clinical rotations and were sent home to attend online classes. A complete paradigm shift emerged about entrance exams: the SAT and ACT were eliminated for college applicants, and the MCAT for medical school applicants. This was unthinkable before the pandemic descended upon us, but benchmarks suddenly evaporated to adjust to the new reality. Then there followed disastrous financial losses by institutions of higher learning as well as academic medical centers and teaching hospitals, all slashing their budgets, furloughing employees, cutting salaries, and eliminating programs. Even the “sacred” tenure of senior faculty became a casualty of the financial “exigency.” Children’s nutrition suffered, especially among those in lower socioeconomic groups for whom the main meal of the day was the school lunch, and was made worse by their parents’ loss of income. For millions of people, the emotional toll was inevitable following the draconian measure of closing all educational institutions to contain the spread of the pandemic.

Family burden. Sheltering at home might have been fun for a few days, but after many weeks, it festered into a major stress, especially for those living in a small house, condominium, or apartment. The resilience of many families was tested as the exercise of freedoms collided with the fear of getting infected. Families were deprived of celebrating birthdays, weddings, funerals, graduation parties, retirement parties, Mother’s Day, Father’s Day, and various religious holidays, including Easter, Passover, and Eid al-Fitr.

Sexual burden. Intimacy and sexual contact between consenting adults living apart were sacrificed on the altar of the pernicious viral pandemic. Mandatory social distancing of 6 feet or more to avoid each other’s droplets emanating from simple speech, not just sneezing or coughing, makes intimacy practically impossible. Thus, physical closeness became taboo, and avoiding another person’s saliva or body secretions became a must to avoid contracting the virus. Being single was quite a lonely experience during this pandemic!

Entertainment deprivation. Americans are known to thrive on an extensive diet of spectator sports. Going to football, basketball, baseball, or hockey games to root for one’s team is intrinsically American. The pursuit of happiness extends to attending concerts, movies, Broadway shows, theme parks, and cruises with thousands of others. The pandemic ripped all those pleasurable leisure activities from our daily lives, leaving a big hole in people’s lives at the precise time fun activities were needed as a useful diversion from the dismal stress of a pandemic. To make things worse, it is uncertain when (if ever) such group activities will be restored, especially if the pandemic returns with another wave. But optimists would hurry to remind us that the “Roaring 20s” blossomed in the decade following the 1918 Spanish Flu pandemic.

Continue to: Legal system

Legal system. Astounding changes were instigated by the pandemic, such as the release of thousands of inmates, including felons, to avoid the spread of the virus in crowded prisons. For us psychiatrists, the silver lining in that unexpected action is that many of those released were patients with mental illness who were incarcerated because of the lack of hospitals that would take them. The police started issuing citations instead of arresting and jailing violators. Enforcement of the law was welcome when it targeted those who gouged the public for personal profit during the scarcity of masks, sanitizers, or even toilet paper and soap.

Medical practice. In addition to delaying medical care for patients, the freeze on so-called elective surgeries or procedures (many of which were actually necessary) was financially ruinous for physicians. Another regrettable consequence of the pandemic is a drop in pediatric vaccinations because parents were reluctant to take their children to the pediatrician. On a more positive note, the massive switch to telehealth was advantageous for both patients and psychiatrists because this technology is well-suited for psychiatric care. Fortunately, regulations that hampered telepsychiatry practice were substantially loosened or eliminated, and even the usually sacrosanct HIPAA regulations were temporarily sidelined.

Medical research. Both human and animal research came to a screeching halt, and many research assistants were furloughed. Data collection was disrupted, and a generation of scientific and medical discoveries became a casualty of the pandemic.

Medical literature. It was stunning to see how quickly COVID-19 occupied most of the pages of prominent journals. The scholarly articles were frankly quite useful, covering topics ranging from risk factors to early symptoms to treatment and pathophysiology across multiple organs. As with other paradigm shifts, there was an accelerated publication push, sometimes with expedited peer reviews to inform health care workers and the public while the pandemic was still raging. However, a couple of very prominent journals had to retract flawed articles that were hastily published without the usual due diligence and rigorous peer review. The pandemic clearly disrupted the science publishing process.

Travel effects. The steep reduction of flights (by 98%) was financially catastrophic, not only for airline companies but to business travel across the country. However, fewer cars on the road resulted in fewer accidents and deaths, and also reduced pollution. Paradoxically, to prevent crowding in subways, trains, and buses, officials reversed their traditional instructions and advised the public to drive their own cars instead of using public transportation!

Continue to: Heroism of front-line medical personnel

Heroism of front-line medical personnel. Everyone saluted and prayed for the health care professionals working at the bedside of highly infectious patients who needed 24/7 intensive care. Many have died while carrying out the noble but hazardous medical duties. Those heroes deserve our lasting respect and admiration.

The COVID-19 pandemic insidiously permeated and altered every aspect of our complex society and revealed how fragile our “normal lifestyle” really is. It is possible that nothing will ever be the same again, and an uneasy sense of vulnerability will engulf us as we cautiously return to a “new normal.” Even our language has expanded with the lexicon of pandemic terminology (Table). We all pray and hope that this plague never returns. And let’s hope one or more vaccines are developed soon so we can manage future recurrences like the annual flu season. In the meantime, keep your masks and sanitizers close by…

Postscript: Shortly after I completed this editorial, the ongoing COVID-19 plague was overshadowed by the scourge of racism, with massive protests, at times laced by violence, triggered by the death of a black man in custody of the police, under condemnable circumstances. The COVID-19 pandemic and the necessary social distancing it requires were temporarily ignored during the ensuing protests. The combined effect of those overlapping scourges are jarring to the country’s psyche, complicating and perhaps sabotaging the social recovery from the pandemic.

As the life-altering coronavirus disease 2019 (COVID-19) pandemic gradually ebbs, we are all its survivors. Now, we are experiencing COVID-19 fatigue, trying to emerge from its dense fog that pervaded every facet of our lives. We are fully cognizant that there will not be a return to the previous “normal.” The pernicious virus had a transformative effect that did not spare any component of our society. Full recovery will not be easy.

As the uncertainty lingers about another devastating return of the pandemic later this year, we can see the reverberation of this invisible assault on human existence. Although a relatively small fraction of the population lost their lives, the rest of us are valiantly trying to readjust to the multiple ways our world has changed. Consider the following abrupt and sweeping burdens inflicted by the pandemic within a few short weeks:

Mental health. The acute stress of thanatophobia generated a triad of anxiety, depression, and nosophobia on a large scale. The demand for psychiatric care rapidly escalated. Suicide rate increased not only because of the stress of being locked down at home (alien to most people’s lifestyle) but because of the coincidental timing of the pandemic during April and May, the peak time of year for suicide. Animal researchers use immobilization as a paradigm to stress a rat or mouse. Many humans immobilized during the pandemic have developed exquisite empathy towards those rodents! The impact on children may also have long-term effects because playing and socializing with friends is a vital part of their lives. Parents have noticed dysphoria and acting out among their children, and an intense compensatory preoccupation with video games and electronic communications with friends.

Physical health. Medical care focused heavily on COVID-19 victims, to the detriment of all other medical conditions. Non-COVID-19 hospital admissions plummeted, and all elective surgeries and procedures were put on hold, depriving many people of medical care they badly needed. Emergency department (ED) visits also declined dramatically, including the usual flow of heart attacks, stroke, pulmonary embolus, asthma attacks, etc. The minimization of driving greatly reduced the admission of accident victims to EDs. Colonoscopies, cardiac stents, hip replacements, MRIs, mammography, and other procedures that are vital to maintain health and quality of life were halted. Dentists shuttered their practices due to the high risk of infection from exposure to oral secretions and breathing. One can only imagine the suffering of having a toothache with no dental help available, and how that might lead to narcotic abuse.

Social health. The imperative of social distancing disrupted most ordinary human activities, such as dining out, sitting in an auditorium for Grand Rounds or a lecture, visiting friends at their homes, the cherished interactions between grandparents and grandchildren (the lack of which I painfully experienced), and even seeing each other’s smiles behind the ubiquitous masks. And forget about hugging or kissing. The aversion to being near anyone who is coughing or sneezing led to an adaptive social paranoia and the social shunning of anyone who appeared to have an upper respiratory infection, even if it was unrelated to COVID-19.

Redemption for the pharmaceutical industry. The deadly pandemic intensified the public’s awareness of the importance of developing treatments and vaccines for COVID-19. The often-demonized pharmaceutical companies, with their extensive R&D infrastructure, emerged as a major source of hope for discovering an effective treatment for the coronavirus infection, or—better still—one or more vaccines that will enable society to return to its normal functions. It was quite impressive how many pharmaceutical companies “came to the rescue” with clinical trials to repurpose existing medications or to develop new ones. It was very encouraging to see multiple vaccine candidates being developed and expedited for testing around the world. A process that usually takes years was reduced to a few months, thanks to the existing technical infrastructure and thousands of scientists who enable rapid drug development. It is possible that the public may gradually modify its perception of the pharmaceutical industry from a “corporate villain” to an “indispensable health industry” for urgent medical crises such as a pandemic, and also for hundreds of medical diseases that are still in need of safe, effective therapies.

Economic burden. The unimaginable nightmare scenario of a total shutdown of all businesses led to the unprecedented loss of millions of jobs and livelihoods, reflected in miles-long lines of families at food banks. Overnight, the government switched from worrying about its $20-trillion deficit to printing several more trillion dollars to rescue the economy from collapse. The huge magnitude of a trillion can be appreciated if one is aware that it takes roughly 32 years to count to 1 billion, and 32,000 years to count to 1 trillion. Stimulating the economy while the gross domestic product threatens to sink by terrifying percentages (20% to 30%) was urgently needed, even though it meant mortgaging the future, especially when interest rates, and servicing the debt, will inevitably rise from the current zero to much higher levels in the future. The collapse of the once-thriving airline industry (bookings were down an estimated 98%) is an example of why desperate measures were needed to salvage an economy paralyzed by a viral pandemic.

Continue to: Political repercussions

Political repercussions. In our already hyperpartisan country, the COVID-19 crisis created more fissures across party lines. The blame game escalated as each side tried to exploit the crisis for political gain during a presidential election year. None of the leaders, from mayors to governors to the president, had any notion of how to wisely manage an unforeseen catastrophic pandemic. Thus, a political cacophony has developed, further exacerbating the public’s anxiety and uncertainty, especially about how and when the pandemic will end.

Education disruption. Never before have all schools and colleges around the country abruptly closed and sent students of all ages to shelter at home. Massive havoc ensued, with a wholesale switch to solitary online learning, the loss of the unique school and college social experience in the classroom and on campus, and the loss of experiencing commencement to receive a diploma (an important milestone for every graduate). Even medical students were not allowed to complete their clinical rotations and were sent home to attend online classes. A complete paradigm shift emerged about entrance exams: the SAT and ACT were eliminated for college applicants, and the MCAT for medical school applicants. This was unthinkable before the pandemic descended upon us, but benchmarks suddenly evaporated to adjust to the new reality. Then there followed disastrous financial losses by institutions of higher learning as well as academic medical centers and teaching hospitals, all slashing their budgets, furloughing employees, cutting salaries, and eliminating programs. Even the “sacred” tenure of senior faculty became a casualty of the financial “exigency.” Children’s nutrition suffered, especially among those in lower socioeconomic groups for whom the main meal of the day was the school lunch, and was made worse by their parents’ loss of income. For millions of people, the emotional toll was inevitable following the draconian measure of closing all educational institutions to contain the spread of the pandemic.

Family burden. Sheltering at home might have been fun for a few days, but after many weeks, it festered into a major stress, especially for those living in a small house, condominium, or apartment. The resilience of many families was tested as the exercise of freedoms collided with the fear of getting infected. Families were deprived of celebrating birthdays, weddings, funerals, graduation parties, retirement parties, Mother’s Day, Father’s Day, and various religious holidays, including Easter, Passover, and Eid al-Fitr.

Sexual burden. Intimacy and sexual contact between consenting adults living apart were sacrificed on the altar of the pernicious viral pandemic. Mandatory social distancing of 6 feet or more to avoid each other’s droplets emanating from simple speech, not just sneezing or coughing, makes intimacy practically impossible. Thus, physical closeness became taboo, and avoiding another person’s saliva or body secretions became a must to avoid contracting the virus. Being single was quite a lonely experience during this pandemic!

Entertainment deprivation. Americans are known to thrive on an extensive diet of spectator sports. Going to football, basketball, baseball, or hockey games to root for one’s team is intrinsically American. The pursuit of happiness extends to attending concerts, movies, Broadway shows, theme parks, and cruises with thousands of others. The pandemic ripped all those pleasurable leisure activities from our daily lives, leaving a big hole in people’s lives at the precise time fun activities were needed as a useful diversion from the dismal stress of a pandemic. To make things worse, it is uncertain when (if ever) such group activities will be restored, especially if the pandemic returns with another wave. But optimists would hurry to remind us that the “Roaring 20s” blossomed in the decade following the 1918 Spanish Flu pandemic.

Continue to: Legal system

Legal system. Astounding changes were instigated by the pandemic, such as the release of thousands of inmates, including felons, to avoid the spread of the virus in crowded prisons. For us psychiatrists, the silver lining in that unexpected action is that many of those released were patients with mental illness who were incarcerated because of the lack of hospitals that would take them. The police started issuing citations instead of arresting and jailing violators. Enforcement of the law was welcome when it targeted those who gouged the public for personal profit during the scarcity of masks, sanitizers, or even toilet paper and soap.

Medical practice. In addition to delaying medical care for patients, the freeze on so-called elective surgeries or procedures (many of which were actually necessary) was financially ruinous for physicians. Another regrettable consequence of the pandemic is a drop in pediatric vaccinations because parents were reluctant to take their children to the pediatrician. On a more positive note, the massive switch to telehealth was advantageous for both patients and psychiatrists because this technology is well-suited for psychiatric care. Fortunately, regulations that hampered telepsychiatry practice were substantially loosened or eliminated, and even the usually sacrosanct HIPAA regulations were temporarily sidelined.

Medical research. Both human and animal research came to a screeching halt, and many research assistants were furloughed. Data collection was disrupted, and a generation of scientific and medical discoveries became a casualty of the pandemic.

Medical literature. It was stunning to see how quickly COVID-19 occupied most of the pages of prominent journals. The scholarly articles were frankly quite useful, covering topics ranging from risk factors to early symptoms to treatment and pathophysiology across multiple organs. As with other paradigm shifts, there was an accelerated publication push, sometimes with expedited peer reviews to inform health care workers and the public while the pandemic was still raging. However, a couple of very prominent journals had to retract flawed articles that were hastily published without the usual due diligence and rigorous peer review. The pandemic clearly disrupted the science publishing process.

Travel effects. The steep reduction of flights (by 98%) was financially catastrophic, not only for airline companies but to business travel across the country. However, fewer cars on the road resulted in fewer accidents and deaths, and also reduced pollution. Paradoxically, to prevent crowding in subways, trains, and buses, officials reversed their traditional instructions and advised the public to drive their own cars instead of using public transportation!

Continue to: Heroism of front-line medical personnel

Heroism of front-line medical personnel. Everyone saluted and prayed for the health care professionals working at the bedside of highly infectious patients who needed 24/7 intensive care. Many have died while carrying out the noble but hazardous medical duties. Those heroes deserve our lasting respect and admiration.

The COVID-19 pandemic insidiously permeated and altered every aspect of our complex society and revealed how fragile our “normal lifestyle” really is. It is possible that nothing will ever be the same again, and an uneasy sense of vulnerability will engulf us as we cautiously return to a “new normal.” Even our language has expanded with the lexicon of pandemic terminology (Table). We all pray and hope that this plague never returns. And let’s hope one or more vaccines are developed soon so we can manage future recurrences like the annual flu season. In the meantime, keep your masks and sanitizers close by…

Postscript: Shortly after I completed this editorial, the ongoing COVID-19 plague was overshadowed by the scourge of racism, with massive protests, at times laced by violence, triggered by the death of a black man in custody of the police, under condemnable circumstances. The COVID-19 pandemic and the necessary social distancing it requires were temporarily ignored during the ensuing protests. The combined effect of those overlapping scourges are jarring to the country’s psyche, complicating and perhaps sabotaging the social recovery from the pandemic.

As the life-altering coronavirus disease 2019 (COVID-19) pandemic gradually ebbs, we are all its survivors. Now, we are experiencing COVID-19 fatigue, trying to emerge from its dense fog that pervaded every facet of our lives. We are fully cognizant that there will not be a return to the previous “normal.” The pernicious virus had a transformative effect that did not spare any component of our society. Full recovery will not be easy.

As the uncertainty lingers about another devastating return of the pandemic later this year, we can see the reverberation of this invisible assault on human existence. Although a relatively small fraction of the population lost their lives, the rest of us are valiantly trying to readjust to the multiple ways our world has changed. Consider the following abrupt and sweeping burdens inflicted by the pandemic within a few short weeks:

Mental health. The acute stress of thanatophobia generated a triad of anxiety, depression, and nosophobia on a large scale. The demand for psychiatric care rapidly escalated. Suicide rate increased not only because of the stress of being locked down at home (alien to most people’s lifestyle) but because of the coincidental timing of the pandemic during April and May, the peak time of year for suicide. Animal researchers use immobilization as a paradigm to stress a rat or mouse. Many humans immobilized during the pandemic have developed exquisite empathy towards those rodents! The impact on children may also have long-term effects because playing and socializing with friends is a vital part of their lives. Parents have noticed dysphoria and acting out among their children, and an intense compensatory preoccupation with video games and electronic communications with friends.

Physical health. Medical care focused heavily on COVID-19 victims, to the detriment of all other medical conditions. Non-COVID-19 hospital admissions plummeted, and all elective surgeries and procedures were put on hold, depriving many people of medical care they badly needed. Emergency department (ED) visits also declined dramatically, including the usual flow of heart attacks, stroke, pulmonary embolus, asthma attacks, etc. The minimization of driving greatly reduced the admission of accident victims to EDs. Colonoscopies, cardiac stents, hip replacements, MRIs, mammography, and other procedures that are vital to maintain health and quality of life were halted. Dentists shuttered their practices due to the high risk of infection from exposure to oral secretions and breathing. One can only imagine the suffering of having a toothache with no dental help available, and how that might lead to narcotic abuse.

Social health. The imperative of social distancing disrupted most ordinary human activities, such as dining out, sitting in an auditorium for Grand Rounds or a lecture, visiting friends at their homes, the cherished interactions between grandparents and grandchildren (the lack of which I painfully experienced), and even seeing each other’s smiles behind the ubiquitous masks. And forget about hugging or kissing. The aversion to being near anyone who is coughing or sneezing led to an adaptive social paranoia and the social shunning of anyone who appeared to have an upper respiratory infection, even if it was unrelated to COVID-19.

Redemption for the pharmaceutical industry. The deadly pandemic intensified the public’s awareness of the importance of developing treatments and vaccines for COVID-19. The often-demonized pharmaceutical companies, with their extensive R&D infrastructure, emerged as a major source of hope for discovering an effective treatment for the coronavirus infection, or—better still—one or more vaccines that will enable society to return to its normal functions. It was quite impressive how many pharmaceutical companies “came to the rescue” with clinical trials to repurpose existing medications or to develop new ones. It was very encouraging to see multiple vaccine candidates being developed and expedited for testing around the world. A process that usually takes years was reduced to a few months, thanks to the existing technical infrastructure and thousands of scientists who enable rapid drug development. It is possible that the public may gradually modify its perception of the pharmaceutical industry from a “corporate villain” to an “indispensable health industry” for urgent medical crises such as a pandemic, and also for hundreds of medical diseases that are still in need of safe, effective therapies.

Economic burden. The unimaginable nightmare scenario of a total shutdown of all businesses led to the unprecedented loss of millions of jobs and livelihoods, reflected in miles-long lines of families at food banks. Overnight, the government switched from worrying about its $20-trillion deficit to printing several more trillion dollars to rescue the economy from collapse. The huge magnitude of a trillion can be appreciated if one is aware that it takes roughly 32 years to count to 1 billion, and 32,000 years to count to 1 trillion. Stimulating the economy while the gross domestic product threatens to sink by terrifying percentages (20% to 30%) was urgently needed, even though it meant mortgaging the future, especially when interest rates, and servicing the debt, will inevitably rise from the current zero to much higher levels in the future. The collapse of the once-thriving airline industry (bookings were down an estimated 98%) is an example of why desperate measures were needed to salvage an economy paralyzed by a viral pandemic.

Continue to: Political repercussions

Political repercussions. In our already hyperpartisan country, the COVID-19 crisis created more fissures across party lines. The blame game escalated as each side tried to exploit the crisis for political gain during a presidential election year. None of the leaders, from mayors to governors to the president, had any notion of how to wisely manage an unforeseen catastrophic pandemic. Thus, a political cacophony has developed, further exacerbating the public’s anxiety and uncertainty, especially about how and when the pandemic will end.

Education disruption. Never before have all schools and colleges around the country abruptly closed and sent students of all ages to shelter at home. Massive havoc ensued, with a wholesale switch to solitary online learning, the loss of the unique school and college social experience in the classroom and on campus, and the loss of experiencing commencement to receive a diploma (an important milestone for every graduate). Even medical students were not allowed to complete their clinical rotations and were sent home to attend online classes. A complete paradigm shift emerged about entrance exams: the SAT and ACT were eliminated for college applicants, and the MCAT for medical school applicants. This was unthinkable before the pandemic descended upon us, but benchmarks suddenly evaporated to adjust to the new reality. Then there followed disastrous financial losses by institutions of higher learning as well as academic medical centers and teaching hospitals, all slashing their budgets, furloughing employees, cutting salaries, and eliminating programs. Even the “sacred” tenure of senior faculty became a casualty of the financial “exigency.” Children’s nutrition suffered, especially among those in lower socioeconomic groups for whom the main meal of the day was the school lunch, and was made worse by their parents’ loss of income. For millions of people, the emotional toll was inevitable following the draconian measure of closing all educational institutions to contain the spread of the pandemic.

Family burden. Sheltering at home might have been fun for a few days, but after many weeks, it festered into a major stress, especially for those living in a small house, condominium, or apartment. The resilience of many families was tested as the exercise of freedoms collided with the fear of getting infected. Families were deprived of celebrating birthdays, weddings, funerals, graduation parties, retirement parties, Mother’s Day, Father’s Day, and various religious holidays, including Easter, Passover, and Eid al-Fitr.

Sexual burden. Intimacy and sexual contact between consenting adults living apart were sacrificed on the altar of the pernicious viral pandemic. Mandatory social distancing of 6 feet or more to avoid each other’s droplets emanating from simple speech, not just sneezing or coughing, makes intimacy practically impossible. Thus, physical closeness became taboo, and avoiding another person’s saliva or body secretions became a must to avoid contracting the virus. Being single was quite a lonely experience during this pandemic!

Entertainment deprivation. Americans are known to thrive on an extensive diet of spectator sports. Going to football, basketball, baseball, or hockey games to root for one’s team is intrinsically American. The pursuit of happiness extends to attending concerts, movies, Broadway shows, theme parks, and cruises with thousands of others. The pandemic ripped all those pleasurable leisure activities from our daily lives, leaving a big hole in people’s lives at the precise time fun activities were needed as a useful diversion from the dismal stress of a pandemic. To make things worse, it is uncertain when (if ever) such group activities will be restored, especially if the pandemic returns with another wave. But optimists would hurry to remind us that the “Roaring 20s” blossomed in the decade following the 1918 Spanish Flu pandemic.

Continue to: Legal system

Legal system. Astounding changes were instigated by the pandemic, such as the release of thousands of inmates, including felons, to avoid the spread of the virus in crowded prisons. For us psychiatrists, the silver lining in that unexpected action is that many of those released were patients with mental illness who were incarcerated because of the lack of hospitals that would take them. The police started issuing citations instead of arresting and jailing violators. Enforcement of the law was welcome when it targeted those who gouged the public for personal profit during the scarcity of masks, sanitizers, or even toilet paper and soap.

Medical practice. In addition to delaying medical care for patients, the freeze on so-called elective surgeries or procedures (many of which were actually necessary) was financially ruinous for physicians. Another regrettable consequence of the pandemic is a drop in pediatric vaccinations because parents were reluctant to take their children to the pediatrician. On a more positive note, the massive switch to telehealth was advantageous for both patients and psychiatrists because this technology is well-suited for psychiatric care. Fortunately, regulations that hampered telepsychiatry practice were substantially loosened or eliminated, and even the usually sacrosanct HIPAA regulations were temporarily sidelined.

Medical research. Both human and animal research came to a screeching halt, and many research assistants were furloughed. Data collection was disrupted, and a generation of scientific and medical discoveries became a casualty of the pandemic.

Medical literature. It was stunning to see how quickly COVID-19 occupied most of the pages of prominent journals. The scholarly articles were frankly quite useful, covering topics ranging from risk factors to early symptoms to treatment and pathophysiology across multiple organs. As with other paradigm shifts, there was an accelerated publication push, sometimes with expedited peer reviews to inform health care workers and the public while the pandemic was still raging. However, a couple of very prominent journals had to retract flawed articles that were hastily published without the usual due diligence and rigorous peer review. The pandemic clearly disrupted the science publishing process.

Travel effects. The steep reduction of flights (by 98%) was financially catastrophic, not only for airline companies but to business travel across the country. However, fewer cars on the road resulted in fewer accidents and deaths, and also reduced pollution. Paradoxically, to prevent crowding in subways, trains, and buses, officials reversed their traditional instructions and advised the public to drive their own cars instead of using public transportation!

Continue to: Heroism of front-line medical personnel

Heroism of front-line medical personnel. Everyone saluted and prayed for the health care professionals working at the bedside of highly infectious patients who needed 24/7 intensive care. Many have died while carrying out the noble but hazardous medical duties. Those heroes deserve our lasting respect and admiration.

The COVID-19 pandemic insidiously permeated and altered every aspect of our complex society and revealed how fragile our “normal lifestyle” really is. It is possible that nothing will ever be the same again, and an uneasy sense of vulnerability will engulf us as we cautiously return to a “new normal.” Even our language has expanded with the lexicon of pandemic terminology (Table). We all pray and hope that this plague never returns. And let’s hope one or more vaccines are developed soon so we can manage future recurrences like the annual flu season. In the meantime, keep your masks and sanitizers close by…

Postscript: Shortly after I completed this editorial, the ongoing COVID-19 plague was overshadowed by the scourge of racism, with massive protests, at times laced by violence, triggered by the death of a black man in custody of the police, under condemnable circumstances. The COVID-19 pandemic and the necessary social distancing it requires were temporarily ignored during the ensuing protests. The combined effect of those overlapping scourges are jarring to the country’s psyche, complicating and perhaps sabotaging the social recovery from the pandemic.

Although pelvic examinations may only last a few minutes, the examination is scary and uncomfortable for many patients. To help minimize fear and discomfort, the exam should take place in a comfortable and professional environment. The clinician should provide appropriate gowns, private facilities for undressing, sensitively use draping, and clearly explain the components of the examination. Trained professional chaperones play an important role in intimate physical examinations, including:

• providing reassurance to the patient of the professional integrity of the intimate examination
• supporting and educating the patient during the examination
• increasing the efficiency of the clinician during a procedure
• acting as a witness should a misunderstanding with the patient arise.

Major medical professional societies have issued guidance to clinicians on the use of a chaperone during intimate physical examinations. Professional society guidance ranges from endorsing joint decision-making between physician and patient on the presence of a chaperone to more proscriptive guidance that emphasizes the importance of a chaperone at every intimate physical examination.

Examples of professional societies’ guidance that supports joint decision-making between physician and patient about the presence of a chaperone include:

• American Medical Association: “Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients. Always honor a patient’s request to have a chaperone.”¹
• Society of Obstetricians and Gynaecologists of Canada: “It is a reasonable and acceptable practice to perform a physical examination, including breast and pelvic examination without the presence of a third person in the room unless the woman or health care provider indicates a desire for a third party to be present.” “If the health care provider chooses to have a third person present during all examinations, the health care provider should explain this policy to the woman.”²
• American College of Physicians: “Care and respect should guide the performance of the physical examination. The location and degree of privacy should be appropriate for the examination being performed, with chaperone services as an option. An appropriate setting and sufficient time should be allocated to encourage exploration of aspects of the patient’s life pertinent to health, including habits, relationships, sexuality, vocation, culture, religion, and spirituality.”³

By contrast, the following professional society guidance strongly recommends the presence of a chaperone for every intimate physical examination:

• United States Veterans Administration: “A female chaperone must be in the examination room during breast and pelvic exams…this includes procedures such as urodynamic testing or treatments such as pelvic floor physical therapy.”⁴
• Royal College of Obstetricians and Gynaecologists: “The presence of a chaperone is considered essential for every pelvic examination. Verbal consent should be obtained in the presence of the chaperone who is to be present during the examination and recorded in the notes. If the patient declines the presence of a chaperone, the doctor should explain that a chaperone is also required to help in many cases and then attempt to arrange for the chaperone to be standing nearby within earshot. The reasons for declining a chaperone and alternative arrangements offered should be documented. Consent should also be specific to whether the intended examination is vaginal, rectal or both. Communication skills are essential in conducting intimate examinations.”⁵
• American College Health Association (ACHA): “It is ACHA’s recommendation that, as part of institutional policy, a chaperone be provided for every sensitive medical examination and procedure.”⁶

Continue to: New guidance from ACOG on trained chaperones...

New guidance from ACOG on trained chaperones

The American College of Obstetricians and Gynecologists (ACOG) recently issued a committee opinion recommending “that a chaperone be present for all breast, genital, and rectal examinations. The need for a chaperone is irrespective of the sex or gender of the person performing the examination and applies to examinations performed in the outpatient and inpatient settings, including labor and delivery, as well as during diagnostic studies such as transvaginal ultrasonography and urodynamic testing.”⁷

This new proscriptive guidance will significantly change practice for the many obstetrician-gynecologists who do not routinely have a chaperone present during intimate examinations. The policy provides exceptions to the presence of a chaperone in cases of medical emergencies and if the patient declines a chaperone. ACOG recommends that when a patient declines a chaperone the clinician should educate the patient that a “chaperone is an integral part of the clinical team whose role includes assisting with the examination and protecting the patient and the physician. Any concerns the patient has regarding the presence of a chaperone should be elicited and addressed if feasible. If, after counseling, the patient refuses the chaperone, this decision should be respected and documented in the medical record.”⁷ ACOG discourages the use of family members, medical students, and residents as chaperones.

Training of chaperones

Chaperones are health care professionals who should be trained for their specific role. Chaperones need to protect patient privacy and the confidentiality of health information. Chaperones should be trained to recognize the components of a professional intimate examination and to identify variances from standard practice. In many ambulatory practices, medical assistants perform the role of chaperone. The American Association of Medical Assistants (AAMA) offers national certification for medical assistants through an examination developed by the National Board of Medical Examiners. To be eligible for AAMA certification an individual must complete at least two semesters of medical assisting education that includes courses in anatomy, physiology, pharmacology, and relevant mathematics.

Reporting variances that occur during an intimate examination

Best practices are evolving on how to deal with the rare event of a chaperone witnessing a physician perform an intimate examination that is outside of standard professional practice. Chaperones may be reluctant to report a variance because physicians are in a powerful position, and the accuracy of their report will be challenged, threatening the chaperone’s employment. Processes for encouraging all team members to report concerns must be clearly explained to the chaperone and other members of the health care team. Clinicians should be aware that deviations from standard practice will be reported and investigated. Medical practices must develop a reporting system that ensures the reporting individual will be protected from retaliation.

In addition, the chaperone needs to know to whom they should report a variance. In large multispecialty medical practices, chaperones often can report concerns to nursing leaders or human resources. In small ambulatory practices, chaperones may be advised to report concerns about a physician to the practice manager or medical director. Regardless, every practice should have the best process for reporting a concern. In turn, the practice leaders who are responsible for investigating reports of concerning behavior should have a defined process for confidentially interviewing the chaperone, clinician, and patient.

Even when a chaperone is present for intimate examinations, problems can arise if the chaperone is not trained to recognize variances from standard practice or does not have a clear means for reporting variances and when the practice does not have a process for investigating reported variances.

Sadly, misconduct has been documented among priests, ministers, sports coaches, professors, scout masters, and clinicians. Trusted professionals are in positions of power in relation to their clients, patients, and students. Physicians and nurses are held in high esteem and trust by patients. To preserve the trust of the public we must treat all people with dignity and respect their autonomy. The presence of a chaperone during intimate examinations may help us fulfill Hippocrates’ edict, “First, do no harm.” ●

Although pelvic examinations may only last a few minutes, the examination is scary and uncomfortable for many patients. To help minimize fear and discomfort, the exam should take place in a comfortable and professional environment. The clinician should provide appropriate gowns, private facilities for undressing, sensitively use draping, and clearly explain the components of the examination. Trained professional chaperones play an important role in intimate physical examinations, including:

• providing reassurance to the patient of the professional integrity of the intimate examination
• supporting and educating the patient during the examination
• increasing the efficiency of the clinician during a procedure
• acting as a witness should a misunderstanding with the patient arise.

Major medical professional societies have issued guidance to clinicians on the use of a chaperone during intimate physical examinations. Professional society guidance ranges from endorsing joint decision-making between physician and patient on the presence of a chaperone to more proscriptive guidance that emphasizes the importance of a chaperone at every intimate physical examination.

Examples of professional societies’ guidance that supports joint decision-making between physician and patient about the presence of a chaperone include:

• American Medical Association: “Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients. Always honor a patient’s request to have a chaperone.”¹
• Society of Obstetricians and Gynaecologists of Canada: “It is a reasonable and acceptable practice to perform a physical examination, including breast and pelvic examination without the presence of a third person in the room unless the woman or health care provider indicates a desire for a third party to be present.” “If the health care provider chooses to have a third person present during all examinations, the health care provider should explain this policy to the woman.”²
• American College of Physicians: “Care and respect should guide the performance of the physical examination. The location and degree of privacy should be appropriate for the examination being performed, with chaperone services as an option. An appropriate setting and sufficient time should be allocated to encourage exploration of aspects of the patient’s life pertinent to health, including habits, relationships, sexuality, vocation, culture, religion, and spirituality.”³

By contrast, the following professional society guidance strongly recommends the presence of a chaperone for every intimate physical examination:

• United States Veterans Administration: “A female chaperone must be in the examination room during breast and pelvic exams…this includes procedures such as urodynamic testing or treatments such as pelvic floor physical therapy.”⁴
• Royal College of Obstetricians and Gynaecologists: “The presence of a chaperone is considered essential for every pelvic examination. Verbal consent should be obtained in the presence of the chaperone who is to be present during the examination and recorded in the notes. If the patient declines the presence of a chaperone, the doctor should explain that a chaperone is also required to help in many cases and then attempt to arrange for the chaperone to be standing nearby within earshot. The reasons for declining a chaperone and alternative arrangements offered should be documented. Consent should also be specific to whether the intended examination is vaginal, rectal or both. Communication skills are essential in conducting intimate examinations.”⁵
• American College Health Association (ACHA): “It is ACHA’s recommendation that, as part of institutional policy, a chaperone be provided for every sensitive medical examination and procedure.”⁶

Continue to: New guidance from ACOG on trained chaperones...

New guidance from ACOG on trained chaperones

The American College of Obstetricians and Gynecologists (ACOG) recently issued a committee opinion recommending “that a chaperone be present for all breast, genital, and rectal examinations. The need for a chaperone is irrespective of the sex or gender of the person performing the examination and applies to examinations performed in the outpatient and inpatient settings, including labor and delivery, as well as during diagnostic studies such as transvaginal ultrasonography and urodynamic testing.”⁷

This new proscriptive guidance will significantly change practice for the many obstetrician-gynecologists who do not routinely have a chaperone present during intimate examinations. The policy provides exceptions to the presence of a chaperone in cases of medical emergencies and if the patient declines a chaperone. ACOG recommends that when a patient declines a chaperone the clinician should educate the patient that a “chaperone is an integral part of the clinical team whose role includes assisting with the examination and protecting the patient and the physician. Any concerns the patient has regarding the presence of a chaperone should be elicited and addressed if feasible. If, after counseling, the patient refuses the chaperone, this decision should be respected and documented in the medical record.”⁷ ACOG discourages the use of family members, medical students, and residents as chaperones.

Training of chaperones

Chaperones are health care professionals who should be trained for their specific role. Chaperones need to protect patient privacy and the confidentiality of health information. Chaperones should be trained to recognize the components of a professional intimate examination and to identify variances from standard practice. In many ambulatory practices, medical assistants perform the role of chaperone. The American Association of Medical Assistants (AAMA) offers national certification for medical assistants through an examination developed by the National Board of Medical Examiners. To be eligible for AAMA certification an individual must complete at least two semesters of medical assisting education that includes courses in anatomy, physiology, pharmacology, and relevant mathematics.

Reporting variances that occur during an intimate examination

Best practices are evolving on how to deal with the rare event of a chaperone witnessing a physician perform an intimate examination that is outside of standard professional practice. Chaperones may be reluctant to report a variance because physicians are in a powerful position, and the accuracy of their report will be challenged, threatening the chaperone’s employment. Processes for encouraging all team members to report concerns must be clearly explained to the chaperone and other members of the health care team. Clinicians should be aware that deviations from standard practice will be reported and investigated. Medical practices must develop a reporting system that ensures the reporting individual will be protected from retaliation.

In addition, the chaperone needs to know to whom they should report a variance. In large multispecialty medical practices, chaperones often can report concerns to nursing leaders or human resources. In small ambulatory practices, chaperones may be advised to report concerns about a physician to the practice manager or medical director. Regardless, every practice should have the best process for reporting a concern. In turn, the practice leaders who are responsible for investigating reports of concerning behavior should have a defined process for confidentially interviewing the chaperone, clinician, and patient.

Even when a chaperone is present for intimate examinations, problems can arise if the chaperone is not trained to recognize variances from standard practice or does not have a clear means for reporting variances and when the practice does not have a process for investigating reported variances.

Sadly, misconduct has been documented among priests, ministers, sports coaches, professors, scout masters, and clinicians. Trusted professionals are in positions of power in relation to their clients, patients, and students. Physicians and nurses are held in high esteem and trust by patients. To preserve the trust of the public we must treat all people with dignity and respect their autonomy. The presence of a chaperone during intimate examinations may help us fulfill Hippocrates’ edict, “First, do no harm.” ●

Although pelvic examinations may only last a few minutes, the examination is scary and uncomfortable for many patients. To help minimize fear and discomfort, the exam should take place in a comfortable and professional environment. The clinician should provide appropriate gowns, private facilities for undressing, sensitively use draping, and clearly explain the components of the examination. Trained professional chaperones play an important role in intimate physical examinations, including:

• providing reassurance to the patient of the professional integrity of the intimate examination
• supporting and educating the patient during the examination
• increasing the efficiency of the clinician during a procedure
• acting as a witness should a misunderstanding with the patient arise.

Major medical professional societies have issued guidance to clinicians on the use of a chaperone during intimate physical examinations. Professional society guidance ranges from endorsing joint decision-making between physician and patient on the presence of a chaperone to more proscriptive guidance that emphasizes the importance of a chaperone at every intimate physical examination.

Examples of professional societies’ guidance that supports joint decision-making between physician and patient about the presence of a chaperone include:

• American Medical Association: “Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients. Always honor a patient’s request to have a chaperone.”¹
• Society of Obstetricians and Gynaecologists of Canada: “It is a reasonable and acceptable practice to perform a physical examination, including breast and pelvic examination without the presence of a third person in the room unless the woman or health care provider indicates a desire for a third party to be present.” “If the health care provider chooses to have a third person present during all examinations, the health care provider should explain this policy to the woman.”²
• American College of Physicians: “Care and respect should guide the performance of the physical examination. The location and degree of privacy should be appropriate for the examination being performed, with chaperone services as an option. An appropriate setting and sufficient time should be allocated to encourage exploration of aspects of the patient’s life pertinent to health, including habits, relationships, sexuality, vocation, culture, religion, and spirituality.”³

By contrast, the following professional society guidance strongly recommends the presence of a chaperone for every intimate physical examination:

• United States Veterans Administration: “A female chaperone must be in the examination room during breast and pelvic exams…this includes procedures such as urodynamic testing or treatments such as pelvic floor physical therapy.”⁴
• Royal College of Obstetricians and Gynaecologists: “The presence of a chaperone is considered essential for every pelvic examination. Verbal consent should be obtained in the presence of the chaperone who is to be present during the examination and recorded in the notes. If the patient declines the presence of a chaperone, the doctor should explain that a chaperone is also required to help in many cases and then attempt to arrange for the chaperone to be standing nearby within earshot. The reasons for declining a chaperone and alternative arrangements offered should be documented. Consent should also be specific to whether the intended examination is vaginal, rectal or both. Communication skills are essential in conducting intimate examinations.”⁵
• American College Health Association (ACHA): “It is ACHA’s recommendation that, as part of institutional policy, a chaperone be provided for every sensitive medical examination and procedure.”⁶

Continue to: New guidance from ACOG on trained chaperones...

New guidance from ACOG on trained chaperones

The American College of Obstetricians and Gynecologists (ACOG) recently issued a committee opinion recommending “that a chaperone be present for all breast, genital, and rectal examinations. The need for a chaperone is irrespective of the sex or gender of the person performing the examination and applies to examinations performed in the outpatient and inpatient settings, including labor and delivery, as well as during diagnostic studies such as transvaginal ultrasonography and urodynamic testing.”⁷

This new proscriptive guidance will significantly change practice for the many obstetrician-gynecologists who do not routinely have a chaperone present during intimate examinations. The policy provides exceptions to the presence of a chaperone in cases of medical emergencies and if the patient declines a chaperone. ACOG recommends that when a patient declines a chaperone the clinician should educate the patient that a “chaperone is an integral part of the clinical team whose role includes assisting with the examination and protecting the patient and the physician. Any concerns the patient has regarding the presence of a chaperone should be elicited and addressed if feasible. If, after counseling, the patient refuses the chaperone, this decision should be respected and documented in the medical record.”⁷ ACOG discourages the use of family members, medical students, and residents as chaperones.

Training of chaperones

Chaperones are health care professionals who should be trained for their specific role. Chaperones need to protect patient privacy and the confidentiality of health information. Chaperones should be trained to recognize the components of a professional intimate examination and to identify variances from standard practice. In many ambulatory practices, medical assistants perform the role of chaperone. The American Association of Medical Assistants (AAMA) offers national certification for medical assistants through an examination developed by the National Board of Medical Examiners. To be eligible for AAMA certification an individual must complete at least two semesters of medical assisting education that includes courses in anatomy, physiology, pharmacology, and relevant mathematics.

Reporting variances that occur during an intimate examination

Best practices are evolving on how to deal with the rare event of a chaperone witnessing a physician perform an intimate examination that is outside of standard professional practice. Chaperones may be reluctant to report a variance because physicians are in a powerful position, and the accuracy of their report will be challenged, threatening the chaperone’s employment. Processes for encouraging all team members to report concerns must be clearly explained to the chaperone and other members of the health care team. Clinicians should be aware that deviations from standard practice will be reported and investigated. Medical practices must develop a reporting system that ensures the reporting individual will be protected from retaliation.

In addition, the chaperone needs to know to whom they should report a variance. In large multispecialty medical practices, chaperones often can report concerns to nursing leaders or human resources. In small ambulatory practices, chaperones may be advised to report concerns about a physician to the practice manager or medical director. Regardless, every practice should have the best process for reporting a concern. In turn, the practice leaders who are responsible for investigating reports of concerning behavior should have a defined process for confidentially interviewing the chaperone, clinician, and patient.

Even when a chaperone is present for intimate examinations, problems can arise if the chaperone is not trained to recognize variances from standard practice or does not have a clear means for reporting variances and when the practice does not have a process for investigating reported variances.

Sadly, misconduct has been documented among priests, ministers, sports coaches, professors, scout masters, and clinicians. Trusted professionals are in positions of power in relation to their clients, patients, and students. Physicians and nurses are held in high esteem and trust by patients. To preserve the trust of the public we must treat all people with dignity and respect their autonomy. The presence of a chaperone during intimate examinations may help us fulfill Hippocrates’ edict, “First, do no harm.” ●

Psychiatry has been historically plagued by absurd misnomers. It started with the laughable “mental hygiene,” coined by William Sweetser, MD, in 1843, 1 year before the original 13 members of the Association of Medical Superintendents of American Institutions for the Insane established what in 1921 was renamed the American Psychiatric Association. Mental hygiene evokes an image of psychiatrists scrubbing the brains of mentally ill patients with soap and water! That term was neither medically nor scientifically appropriate, but it stuck for decades.

Enter “mental health.” In 1949, the National Institute of Mental Health was established. It is the 5th oldest of the 27 Institutes and Centers of the National Institutes of Health. Then, in 1963, Congress passed the Community Mental Health Act, which established Community Mental Health Centers around the country. It is perplexing that the term “health” was used instead of “illness,” when psychiatry is a medical specialty that treats mental disorders. Health is certainly the goal of all medical specialties, but cardiology was never called “heart health,” neurology was never called “brain health,” and pediatrics was never called “children’s health.” Like all its sister medical specialties, psychiatry treats disease and syndromes, but somehow, it has been transmogrified into “mental health.” Perhaps it was meant to be a euphemism to disguise and avert the unfortunate stigma associated with mental illness back during the institutionalization era.

The advent of ‘behavioral health’

Then suddenly, the term “behavioral health” was coined and began to be used as a substitute for psychiatry, further distorting psychiatry’s medical identity. Behavioral health is completely different from psychiatry. It refers to healthy behaviors that people should uphold throughout their lives to maintain their overall health and well-being, including eating a balanced diet, exercising regularly, avoiding tobacco and drugs of abuse, practicing safe sex, and establishing meaningful social relationships. So behavioral health promotes a healthy lifestyle, and that could very aptly apply to cardiology, pulmonology, nephrology, or hepatology, where good nutrition and avoiding weight gain, smoking, and sedentary living can reduce the risk for various medical diseases and early mortality. For dermatologists, behavioral health is avoiding sunburn, and for dentists, it is regular brushing and flossing.

Thus, behavioral health is a term that broadly promotes physical health and well-being, and should not be conflated with mental disorders. It is by no means synonymous with psychiatry, a medical discipline that addresses serious disorders of thought, emotions, affect, delusions, hallucinations, suicide, homicide, impulsivity, obsessions and compulsions, motivation, memory, attention, and judgment. Psychiatry is far more than behaviors that promote healthy living. Psychiatry contends with acute and chronic mental disorders, similar to other chronic medical conditions such as chronic heart, lung, gastrointestinal, or kidney diseases. Psychiatric disorders can emerge in individuals despite—and irrespective of—a healthy lifestyle promoted by behavioral health. Most psychiatric disorders have been shown to be highly genetic, and can be triggered by gene-environment interactions, even in the context of a healthful life that behavioral health advocates and fecundates.

I dislike conspiracy theories, but it is legitimate to inquire: Was there a “malicious intent” by insurance companies and managed-care entities when they abruptly replaced the medically accurate term “psychiatry” with the counterfactual “behavioral health”? Did they intend to portray psychiatry as somehow “different” from other medical specialties? Did this phraseological acrobatics facilitate and justify the carving out of psychiatric and addiction care, cursed with an anemic budget and absence of parity for persons with psychiatric brain disorders? Somehow, using behavioral health instead of psychiatry has the unfortunate connotation that patients with mental illness are “misbehaving” by not practicing healthy living, rather than being genuinely medically ill through no fault of their own. That’s a surreptitious de-medicalization of psychiatric brain disorders. It is very likely that the same companies that propagated behavioral health are the ones who came up with the demeaning term “providers,” which lumps physicians with nonphysicians, diluting the medical identify of psychiatrists, and implying a non-equivalence of psychiatric disorders with other medical conditions, which perpetuates stigma.

An erroneous epithet

We are psychiatric physicians, not “behavioral health advisors.” We are graduates of medical schools where we had clinical psychiatric experiences rotating with internal medicine, surgery, obstetrics and gynecology, and pediatrics. We did not have behavioral health rotations. And after graduating with an MD, we spent 4 additional years in psychiatric residency training, not behavioral health training, and we treated very sick patients in emergency departments and on inpatient units, not on behavioral health wards. We receive our board certification from the American Board of Psychiatry and Neurology, not from a behavioral health board. As psychiatrists, we are regularly consulted on the cases of medical and surgical patients who develop psychiatric disorders, which has absolutely nothing to do with behavioral health. Our psychiatric outpatient clinics require extensive medical knowledge and psychopharmacological skills, not behavioral health.

As part of our work as physicians and psychiatrists, we do counsel patients on adopting a healthy lifestyle because many of them have comorbid medical conditions such as diabetes, hypertension, dyslipidemia, chronic obstructive pulmonary disease, asthma, and kidney and gastrointestinal disorders. We practice collaborative care with primary care physicians so we can jointly manage patients’ physical and mental disorders, and help them optimize their lifestyles. Thus, behavioral health is a tiny component of what psychiatrists do, and it does not come close to defining our comprehensive medical care. Similarly, neurologists and cardiologists should not be labeled as behavior health specialties simply because they counsel their patients on how to lower the risk of strokes or heart attacks due to unhealthy lifestyles.

So, let’s call a spade a spade. Psychiatry is psychiatric medical care, not behavioral health. Let’s abandon this erroneous epithet and change the signs outside hospitals and clinics to “psychiatric medicine” facilities. I guarantee that orthopedists would not like it all if you call their specialty “bone health,” and may break your leg if you label their discipline “bone hygiene”… after washing it with soap and water, of course!

Psychiatry has been historically plagued by absurd misnomers. It started with the laughable “mental hygiene,” coined by William Sweetser, MD, in 1843, 1 year before the original 13 members of the Association of Medical Superintendents of American Institutions for the Insane established what in 1921 was renamed the American Psychiatric Association. Mental hygiene evokes an image of psychiatrists scrubbing the brains of mentally ill patients with soap and water! That term was neither medically nor scientifically appropriate, but it stuck for decades.

Enter “mental health.” In 1949, the National Institute of Mental Health was established. It is the 5th oldest of the 27 Institutes and Centers of the National Institutes of Health. Then, in 1963, Congress passed the Community Mental Health Act, which established Community Mental Health Centers around the country. It is perplexing that the term “health” was used instead of “illness,” when psychiatry is a medical specialty that treats mental disorders. Health is certainly the goal of all medical specialties, but cardiology was never called “heart health,” neurology was never called “brain health,” and pediatrics was never called “children’s health.” Like all its sister medical specialties, psychiatry treats disease and syndromes, but somehow, it has been transmogrified into “mental health.” Perhaps it was meant to be a euphemism to disguise and avert the unfortunate stigma associated with mental illness back during the institutionalization era.

The advent of ‘behavioral health’

Then suddenly, the term “behavioral health” was coined and began to be used as a substitute for psychiatry, further distorting psychiatry’s medical identity. Behavioral health is completely different from psychiatry. It refers to healthy behaviors that people should uphold throughout their lives to maintain their overall health and well-being, including eating a balanced diet, exercising regularly, avoiding tobacco and drugs of abuse, practicing safe sex, and establishing meaningful social relationships. So behavioral health promotes a healthy lifestyle, and that could very aptly apply to cardiology, pulmonology, nephrology, or hepatology, where good nutrition and avoiding weight gain, smoking, and sedentary living can reduce the risk for various medical diseases and early mortality. For dermatologists, behavioral health is avoiding sunburn, and for dentists, it is regular brushing and flossing.

Thus, behavioral health is a term that broadly promotes physical health and well-being, and should not be conflated with mental disorders. It is by no means synonymous with psychiatry, a medical discipline that addresses serious disorders of thought, emotions, affect, delusions, hallucinations, suicide, homicide, impulsivity, obsessions and compulsions, motivation, memory, attention, and judgment. Psychiatry is far more than behaviors that promote healthy living. Psychiatry contends with acute and chronic mental disorders, similar to other chronic medical conditions such as chronic heart, lung, gastrointestinal, or kidney diseases. Psychiatric disorders can emerge in individuals despite—and irrespective of—a healthy lifestyle promoted by behavioral health. Most psychiatric disorders have been shown to be highly genetic, and can be triggered by gene-environment interactions, even in the context of a healthful life that behavioral health advocates and fecundates.

I dislike conspiracy theories, but it is legitimate to inquire: Was there a “malicious intent” by insurance companies and managed-care entities when they abruptly replaced the medically accurate term “psychiatry” with the counterfactual “behavioral health”? Did they intend to portray psychiatry as somehow “different” from other medical specialties? Did this phraseological acrobatics facilitate and justify the carving out of psychiatric and addiction care, cursed with an anemic budget and absence of parity for persons with psychiatric brain disorders? Somehow, using behavioral health instead of psychiatry has the unfortunate connotation that patients with mental illness are “misbehaving” by not practicing healthy living, rather than being genuinely medically ill through no fault of their own. That’s a surreptitious de-medicalization of psychiatric brain disorders. It is very likely that the same companies that propagated behavioral health are the ones who came up with the demeaning term “providers,” which lumps physicians with nonphysicians, diluting the medical identify of psychiatrists, and implying a non-equivalence of psychiatric disorders with other medical conditions, which perpetuates stigma.

An erroneous epithet

We are psychiatric physicians, not “behavioral health advisors.” We are graduates of medical schools where we had clinical psychiatric experiences rotating with internal medicine, surgery, obstetrics and gynecology, and pediatrics. We did not have behavioral health rotations. And after graduating with an MD, we spent 4 additional years in psychiatric residency training, not behavioral health training, and we treated very sick patients in emergency departments and on inpatient units, not on behavioral health wards. We receive our board certification from the American Board of Psychiatry and Neurology, not from a behavioral health board. As psychiatrists, we are regularly consulted on the cases of medical and surgical patients who develop psychiatric disorders, which has absolutely nothing to do with behavioral health. Our psychiatric outpatient clinics require extensive medical knowledge and psychopharmacological skills, not behavioral health.

As part of our work as physicians and psychiatrists, we do counsel patients on adopting a healthy lifestyle because many of them have comorbid medical conditions such as diabetes, hypertension, dyslipidemia, chronic obstructive pulmonary disease, asthma, and kidney and gastrointestinal disorders. We practice collaborative care with primary care physicians so we can jointly manage patients’ physical and mental disorders, and help them optimize their lifestyles. Thus, behavioral health is a tiny component of what psychiatrists do, and it does not come close to defining our comprehensive medical care. Similarly, neurologists and cardiologists should not be labeled as behavior health specialties simply because they counsel their patients on how to lower the risk of strokes or heart attacks due to unhealthy lifestyles.

So, let’s call a spade a spade. Psychiatry is psychiatric medical care, not behavioral health. Let’s abandon this erroneous epithet and change the signs outside hospitals and clinics to “psychiatric medicine” facilities. I guarantee that orthopedists would not like it all if you call their specialty “bone health,” and may break your leg if you label their discipline “bone hygiene”… after washing it with soap and water, of course!

Psychiatry has been historically plagued by absurd misnomers. It started with the laughable “mental hygiene,” coined by William Sweetser, MD, in 1843, 1 year before the original 13 members of the Association of Medical Superintendents of American Institutions for the Insane established what in 1921 was renamed the American Psychiatric Association. Mental hygiene evokes an image of psychiatrists scrubbing the brains of mentally ill patients with soap and water! That term was neither medically nor scientifically appropriate, but it stuck for decades.

Enter “mental health.” In 1949, the National Institute of Mental Health was established. It is the 5th oldest of the 27 Institutes and Centers of the National Institutes of Health. Then, in 1963, Congress passed the Community Mental Health Act, which established Community Mental Health Centers around the country. It is perplexing that the term “health” was used instead of “illness,” when psychiatry is a medical specialty that treats mental disorders. Health is certainly the goal of all medical specialties, but cardiology was never called “heart health,” neurology was never called “brain health,” and pediatrics was never called “children’s health.” Like all its sister medical specialties, psychiatry treats disease and syndromes, but somehow, it has been transmogrified into “mental health.” Perhaps it was meant to be a euphemism to disguise and avert the unfortunate stigma associated with mental illness back during the institutionalization era.

The advent of ‘behavioral health’

Then suddenly, the term “behavioral health” was coined and began to be used as a substitute for psychiatry, further distorting psychiatry’s medical identity. Behavioral health is completely different from psychiatry. It refers to healthy behaviors that people should uphold throughout their lives to maintain their overall health and well-being, including eating a balanced diet, exercising regularly, avoiding tobacco and drugs of abuse, practicing safe sex, and establishing meaningful social relationships. So behavioral health promotes a healthy lifestyle, and that could very aptly apply to cardiology, pulmonology, nephrology, or hepatology, where good nutrition and avoiding weight gain, smoking, and sedentary living can reduce the risk for various medical diseases and early mortality. For dermatologists, behavioral health is avoiding sunburn, and for dentists, it is regular brushing and flossing.

Thus, behavioral health is a term that broadly promotes physical health and well-being, and should not be conflated with mental disorders. It is by no means synonymous with psychiatry, a medical discipline that addresses serious disorders of thought, emotions, affect, delusions, hallucinations, suicide, homicide, impulsivity, obsessions and compulsions, motivation, memory, attention, and judgment. Psychiatry is far more than behaviors that promote healthy living. Psychiatry contends with acute and chronic mental disorders, similar to other chronic medical conditions such as chronic heart, lung, gastrointestinal, or kidney diseases. Psychiatric disorders can emerge in individuals despite—and irrespective of—a healthy lifestyle promoted by behavioral health. Most psychiatric disorders have been shown to be highly genetic, and can be triggered by gene-environment interactions, even in the context of a healthful life that behavioral health advocates and fecundates.

I dislike conspiracy theories, but it is legitimate to inquire: Was there a “malicious intent” by insurance companies and managed-care entities when they abruptly replaced the medically accurate term “psychiatry” with the counterfactual “behavioral health”? Did they intend to portray psychiatry as somehow “different” from other medical specialties? Did this phraseological acrobatics facilitate and justify the carving out of psychiatric and addiction care, cursed with an anemic budget and absence of parity for persons with psychiatric brain disorders? Somehow, using behavioral health instead of psychiatry has the unfortunate connotation that patients with mental illness are “misbehaving” by not practicing healthy living, rather than being genuinely medically ill through no fault of their own. That’s a surreptitious de-medicalization of psychiatric brain disorders. It is very likely that the same companies that propagated behavioral health are the ones who came up with the demeaning term “providers,” which lumps physicians with nonphysicians, diluting the medical identify of psychiatrists, and implying a non-equivalence of psychiatric disorders with other medical conditions, which perpetuates stigma.

An erroneous epithet

We are psychiatric physicians, not “behavioral health advisors.” We are graduates of medical schools where we had clinical psychiatric experiences rotating with internal medicine, surgery, obstetrics and gynecology, and pediatrics. We did not have behavioral health rotations. And after graduating with an MD, we spent 4 additional years in psychiatric residency training, not behavioral health training, and we treated very sick patients in emergency departments and on inpatient units, not on behavioral health wards. We receive our board certification from the American Board of Psychiatry and Neurology, not from a behavioral health board. As psychiatrists, we are regularly consulted on the cases of medical and surgical patients who develop psychiatric disorders, which has absolutely nothing to do with behavioral health. Our psychiatric outpatient clinics require extensive medical knowledge and psychopharmacological skills, not behavioral health.

As part of our work as physicians and psychiatrists, we do counsel patients on adopting a healthy lifestyle because many of them have comorbid medical conditions such as diabetes, hypertension, dyslipidemia, chronic obstructive pulmonary disease, asthma, and kidney and gastrointestinal disorders. We practice collaborative care with primary care physicians so we can jointly manage patients’ physical and mental disorders, and help them optimize their lifestyles. Thus, behavioral health is a tiny component of what psychiatrists do, and it does not come close to defining our comprehensive medical care. Similarly, neurologists and cardiologists should not be labeled as behavior health specialties simply because they counsel their patients on how to lower the risk of strokes or heart attacks due to unhealthy lifestyles.

So, let’s call a spade a spade. Psychiatry is psychiatric medical care, not behavioral health. Let’s abandon this erroneous epithet and change the signs outside hospitals and clinics to “psychiatric medicine” facilities. I guarantee that orthopedists would not like it all if you call their specialty “bone health,” and may break your leg if you label their discipline “bone hygiene”… after washing it with soap and water, of course!

Although the US Food and Drug Administration (FDA) has granted emergency use authorization of remdesivir (Gilead Sciences, Inc., Foster City, California) to treat COVID-19, the disease caused by SARS-CoV-2, the drug is considered an investigational agent, not yet formally approved by the FDA and whose efficacy and safety has not yet been fully characterized. Remdesivir has been shown to be effective in reducing the time to recovery of people with COVID-19 disease. It has not been tested in a large controlled clinical trial of pregnant women with COVID-19; however, remdesivir has been given to pregnant women infected with COVID-19 in a compassionate use protocol. For pregnant women, the drug should only be used if the potential benefit justifies the potential risk to the mother and fetus.¹

Pharmacology. Remdesivir is a nucleoside RNA polymerase inhibitor. It has a molecular formula of
C₂₇H₃₅N₆O₈P and a molecular weight of 602.6 g/mol.¹

Mechanism of action. From FDA’s fact sheet: “Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types. Remdesivir triphosphate acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerases with low potential for mitochondrial toxicity.”¹

Treatment protocols

Remdesivir is authorized for treatment of hospitalized patients with severe COVID-19 disease, defined as patients with an oxygen saturation ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). The optimal dose and duration of treatment of COVID-19 with remdesivir is unknown.¹

Prior to initiating treatment, the estimated glomerular filtration rate should be documented to be ≥ 30 mL/min. An excipient used in the remdesivir formulation—sulfobutylether-β-cylcodextrin sodium salt—is renally cleared and accumulates in patients with decreased renal function. 

Baseline liver function tests should be performed prior to treatment and daily during the course of treatment. Remdesivir should not be initiated in patients with an alanine aminotransferase (ALT) level ≥ 5 times the upper limit of normal at baseline. Remdesivir should be discontinued in patients who develop an ALT level ≥ 5 times the upper limit of normal or in patients who develop elevated ALT levels and have increased bilirubin, alkaline phosphatase, or international normalized ratio.¹

In one open-label study (GS-US-540-5773), remdesivir treatment was discontinued due to an adverse event in 5% of patients on a 5-day regimen and in 10% of patients on a 10-day regimen.¹

Under the emergency use authorization, two treatment protocols have been proposed depending on the clinical severity of the COVID-19 infection¹:

• Protocol 1: For people with COVID-19 requiring mechanical ventilation and/or ECMO, the duration of therapy is 10 days, beginning with a loading dose of remdesivir 200 mg infused intravenously for 30 to 120 minutes on day 1 followed by a once-daily dose of 100 mg for 9 days.
• Protocol 2: For people with COVID-19 disease not requiring mechanical ventilation and/or ECMO, the duration of therapy is 5 days, beginning with a loading dose of remdesivir 200 mg infused intravenously for 30 to 120 minutes on day 1 followed by a once-daily dose of 100 mg for 4 days. If the patient does not show clinical improvement, treatment may be extended for an additional 5 days. ​​​​​​

Continue to: Randomized placebo-controlled trial results...

Randomized placebo-controlled trial results

The Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the National Institute of Allergy and Infectious Diseases, is a randomized, double-blind, placebo-controlled trial conducted by Gilead Sciences. The study began in February and evaluated up to 10 days of remdesivir treatment—200 mg IV once daily for 1 day followed by 100 mg IV once daily for 9 days in hospitalized adult patients with COVID-19. Patients were enrolled in a 1:1 manner to remdesivir or placebo, and time to recovery within 28 days after randomization was the trial’s endpoint. According to preliminary analysis of 606 recovered patients, recovery took a median of 11 days in the remdesivir group and 15 days in the placebo group (hazard ratio, 1.31; 95% confidence interval (CI), 1.12‒1.54; P<.001). Mortality rates were 8.0% and 11.6% in the remdesivir and placebo groups, respectively (P=.059).¹

5 vs 10 days of remdesivir treatment

The Gilead Sciences‒sponsored study GS-US-540-5773 was a randomized, open-label multicenter trial of patients with severe COVID-19. A total of 197 adult patients received 10-day remdesivir treatment (200 mg IV once daily for 1 day followed by 100 mg IV once daily for 9 days). An additional 200 adult patients received 5-day remdesivir treatment (200 mg IV once daily followed by 100 mg IV for 4 days). Both groups also received standard of care. Results suggested that patients receiving 10 days of remdesivir had similar improvement in clinical status compared with those receiving a 5-day treatment course (10-to-5 day odds ratio, 0.76; 95% CI, 0.51‒1.13] on day 14).¹ Improvement in clinical status was defined as an improvement of 2 or more points from baseline on a predefined 7-point scale that ranged from hospital discharge to increasing levels of oxygen support to death. Clinical recovery was achieved if patients ceased the need for oxygen support or were discharged.¹

The time to clinical improvement for 50% of patients was similar in each treatment group (10 days in the 5-day group versus 11 days in the 10-day group). By day 14, observed clinical improvement rates were 65% and 54% in the 5- and 10-day treatment groups, respectively. Clinical recovery rates were 70% and 59% in the 5- and 10-day treatment groups and mortality rates were 8% and 11%.¹

Adverse events

The use of remdesivir is contraindicated in patients who are hypersensitive to the drug. Its infusion may cause hypotension, nausea, vomiting, diaphoresis, and shivering. If signs of a clinically significant infusion reaction are observed the infusion should be discontinued. As noted above, elevation in ALT levels occurs with remdesivir treatment.¹

Reporting serious adverse events. If a serious and unexpected adverse event occurs and appears to be associated with the use of remdesivir, the prescribing health care provider and/or the provider’s designee should complete and submit a MedWatch form to the FDA using one of the following methods¹:

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Return form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) to the FDA by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178)
• Gilead requests that all FDA MedWatch forms also be returned to Gilead Pharmacovigilance and Epidemiology: fax: 1-650-522-5477 726; e-mail: [email protected]

Continue to: Drug interactions...

Drug interactions

Remdesivir has not been evaluated for drug-drug interactions in humans. The clinical relevance of in vitro drug interactions also has not been established. According to the FDA, remdesivir is a substrate for the drug metabolizing enzymes CYP2C8, CYP2D6, and CYP3A4, and is a substrate for organic anion transporting polypeptides 1B1 (OAPT1B1) and P-glycoprotein (P-gp) transporters. In vitro, remdesivir inhibits CYP3A4, OATP1B1, OATP1B3, BSEP, MRP4, and NTCP.¹

Pregnancy risk summary

Remdesivir has not been studied adequately in pregnant women and only should be used during pregnancy if the potential benefit of the drug justifies the potential risk to both mother and fetus.

Nonclinical animal studies that included systemic exposure of the predominant circulating metabolite of remdesivir in pregnant rats and rabbits (at 4 times the recommended dose of human exposure) demonstrated no adverse effect on embryofetal development.¹

Breastfeeding

The only information regarding breastfeeding and remdesivir comes from animal studies. The drug and its metabolites were detected in the plasma of nursing rat pups whose mothers given intravenous remdesivir daily from gestation day 6 to lactation day 20. Measured on lactation day 10, remdesivir exposure in the pups was about 1% that of maternal exposure.¹

“Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions from the drug in breastfeeding infants, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for remdesivir and any potential adverse effects on the breastfed child from remdesivir or from the underlying maternal condition.”¹

Although the US Food and Drug Administration (FDA) has granted emergency use authorization of remdesivir (Gilead Sciences, Inc., Foster City, California) to treat COVID-19, the disease caused by SARS-CoV-2, the drug is considered an investigational agent, not yet formally approved by the FDA and whose efficacy and safety has not yet been fully characterized. Remdesivir has been shown to be effective in reducing the time to recovery of people with COVID-19 disease. It has not been tested in a large controlled clinical trial of pregnant women with COVID-19; however, remdesivir has been given to pregnant women infected with COVID-19 in a compassionate use protocol. For pregnant women, the drug should only be used if the potential benefit justifies the potential risk to the mother and fetus.¹

Pharmacology. Remdesivir is a nucleoside RNA polymerase inhibitor. It has a molecular formula of
C₂₇H₃₅N₆O₈P and a molecular weight of 602.6 g/mol.¹

Mechanism of action. From FDA’s fact sheet: “Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types. Remdesivir triphosphate acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerases with low potential for mitochondrial toxicity.”¹

Treatment protocols

Remdesivir is authorized for treatment of hospitalized patients with severe COVID-19 disease, defined as patients with an oxygen saturation ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). The optimal dose and duration of treatment of COVID-19 with remdesivir is unknown.¹

Prior to initiating treatment, the estimated glomerular filtration rate should be documented to be ≥ 30 mL/min. An excipient used in the remdesivir formulation—sulfobutylether-β-cylcodextrin sodium salt—is renally cleared and accumulates in patients with decreased renal function. 

Baseline liver function tests should be performed prior to treatment and daily during the course of treatment. Remdesivir should not be initiated in patients with an alanine aminotransferase (ALT) level ≥ 5 times the upper limit of normal at baseline. Remdesivir should be discontinued in patients who develop an ALT level ≥ 5 times the upper limit of normal or in patients who develop elevated ALT levels and have increased bilirubin, alkaline phosphatase, or international normalized ratio.¹

In one open-label study (GS-US-540-5773), remdesivir treatment was discontinued due to an adverse event in 5% of patients on a 5-day regimen and in 10% of patients on a 10-day regimen.¹

Under the emergency use authorization, two treatment protocols have been proposed depending on the clinical severity of the COVID-19 infection¹:

• Protocol 1: For people with COVID-19 requiring mechanical ventilation and/or ECMO, the duration of therapy is 10 days, beginning with a loading dose of remdesivir 200 mg infused intravenously for 30 to 120 minutes on day 1 followed by a once-daily dose of 100 mg for 9 days.
• Protocol 2: For people with COVID-19 disease not requiring mechanical ventilation and/or ECMO, the duration of therapy is 5 days, beginning with a loading dose of remdesivir 200 mg infused intravenously for 30 to 120 minutes on day 1 followed by a once-daily dose of 100 mg for 4 days. If the patient does not show clinical improvement, treatment may be extended for an additional 5 days. ​​​​​​

Continue to: Randomized placebo-controlled trial results...

Randomized placebo-controlled trial results

The Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the National Institute of Allergy and Infectious Diseases, is a randomized, double-blind, placebo-controlled trial conducted by Gilead Sciences. The study began in February and evaluated up to 10 days of remdesivir treatment—200 mg IV once daily for 1 day followed by 100 mg IV once daily for 9 days in hospitalized adult patients with COVID-19. Patients were enrolled in a 1:1 manner to remdesivir or placebo, and time to recovery within 28 days after randomization was the trial’s endpoint. According to preliminary analysis of 606 recovered patients, recovery took a median of 11 days in the remdesivir group and 15 days in the placebo group (hazard ratio, 1.31; 95% confidence interval (CI), 1.12‒1.54; P<.001). Mortality rates were 8.0% and 11.6% in the remdesivir and placebo groups, respectively (P=.059).¹

5 vs 10 days of remdesivir treatment

The Gilead Sciences‒sponsored study GS-US-540-5773 was a randomized, open-label multicenter trial of patients with severe COVID-19. A total of 197 adult patients received 10-day remdesivir treatment (200 mg IV once daily for 1 day followed by 100 mg IV once daily for 9 days). An additional 200 adult patients received 5-day remdesivir treatment (200 mg IV once daily followed by 100 mg IV for 4 days). Both groups also received standard of care. Results suggested that patients receiving 10 days of remdesivir had similar improvement in clinical status compared with those receiving a 5-day treatment course (10-to-5 day odds ratio, 0.76; 95% CI, 0.51‒1.13] on day 14).¹ Improvement in clinical status was defined as an improvement of 2 or more points from baseline on a predefined 7-point scale that ranged from hospital discharge to increasing levels of oxygen support to death. Clinical recovery was achieved if patients ceased the need for oxygen support or were discharged.¹

The time to clinical improvement for 50% of patients was similar in each treatment group (10 days in the 5-day group versus 11 days in the 10-day group). By day 14, observed clinical improvement rates were 65% and 54% in the 5- and 10-day treatment groups, respectively. Clinical recovery rates were 70% and 59% in the 5- and 10-day treatment groups and mortality rates were 8% and 11%.¹

Adverse events

The use of remdesivir is contraindicated in patients who are hypersensitive to the drug. Its infusion may cause hypotension, nausea, vomiting, diaphoresis, and shivering. If signs of a clinically significant infusion reaction are observed the infusion should be discontinued. As noted above, elevation in ALT levels occurs with remdesivir treatment.¹

Reporting serious adverse events. If a serious and unexpected adverse event occurs and appears to be associated with the use of remdesivir, the prescribing health care provider and/or the provider’s designee should complete and submit a MedWatch form to the FDA using one of the following methods¹:

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Return form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) to the FDA by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178)
• Gilead requests that all FDA MedWatch forms also be returned to Gilead Pharmacovigilance and Epidemiology: fax: 1-650-522-5477 726; e-mail: [email protected]

Continue to: Drug interactions...

Drug interactions

Remdesivir has not been evaluated for drug-drug interactions in humans. The clinical relevance of in vitro drug interactions also has not been established. According to the FDA, remdesivir is a substrate for the drug metabolizing enzymes CYP2C8, CYP2D6, and CYP3A4, and is a substrate for organic anion transporting polypeptides 1B1 (OAPT1B1) and P-glycoprotein (P-gp) transporters. In vitro, remdesivir inhibits CYP3A4, OATP1B1, OATP1B3, BSEP, MRP4, and NTCP.¹

Pregnancy risk summary

Remdesivir has not been studied adequately in pregnant women and only should be used during pregnancy if the potential benefit of the drug justifies the potential risk to both mother and fetus.

Nonclinical animal studies that included systemic exposure of the predominant circulating metabolite of remdesivir in pregnant rats and rabbits (at 4 times the recommended dose of human exposure) demonstrated no adverse effect on embryofetal development.¹

Breastfeeding

The only information regarding breastfeeding and remdesivir comes from animal studies. The drug and its metabolites were detected in the plasma of nursing rat pups whose mothers given intravenous remdesivir daily from gestation day 6 to lactation day 20. Measured on lactation day 10, remdesivir exposure in the pups was about 1% that of maternal exposure.¹

“Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions from the drug in breastfeeding infants, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for remdesivir and any potential adverse effects on the breastfed child from remdesivir or from the underlying maternal condition.”¹

Although the US Food and Drug Administration (FDA) has granted emergency use authorization of remdesivir (Gilead Sciences, Inc., Foster City, California) to treat COVID-19, the disease caused by SARS-CoV-2, the drug is considered an investigational agent, not yet formally approved by the FDA and whose efficacy and safety has not yet been fully characterized. Remdesivir has been shown to be effective in reducing the time to recovery of people with COVID-19 disease. It has not been tested in a large controlled clinical trial of pregnant women with COVID-19; however, remdesivir has been given to pregnant women infected with COVID-19 in a compassionate use protocol. For pregnant women, the drug should only be used if the potential benefit justifies the potential risk to the mother and fetus.¹

Pharmacology. Remdesivir is a nucleoside RNA polymerase inhibitor. It has a molecular formula of
C₂₇H₃₅N₆O₈P and a molecular weight of 602.6 g/mol.¹

Mechanism of action. From FDA’s fact sheet: “Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types. Remdesivir triphosphate acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerases with low potential for mitochondrial toxicity.”¹

Treatment protocols

Remdesivir is authorized for treatment of hospitalized patients with severe COVID-19 disease, defined as patients with an oxygen saturation ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). The optimal dose and duration of treatment of COVID-19 with remdesivir is unknown.¹

Prior to initiating treatment, the estimated glomerular filtration rate should be documented to be ≥ 30 mL/min. An excipient used in the remdesivir formulation—sulfobutylether-β-cylcodextrin sodium salt—is renally cleared and accumulates in patients with decreased renal function. 

Baseline liver function tests should be performed prior to treatment and daily during the course of treatment. Remdesivir should not be initiated in patients with an alanine aminotransferase (ALT) level ≥ 5 times the upper limit of normal at baseline. Remdesivir should be discontinued in patients who develop an ALT level ≥ 5 times the upper limit of normal or in patients who develop elevated ALT levels and have increased bilirubin, alkaline phosphatase, or international normalized ratio.¹

In one open-label study (GS-US-540-5773), remdesivir treatment was discontinued due to an adverse event in 5% of patients on a 5-day regimen and in 10% of patients on a 10-day regimen.¹

Under the emergency use authorization, two treatment protocols have been proposed depending on the clinical severity of the COVID-19 infection¹:

• Protocol 1: For people with COVID-19 requiring mechanical ventilation and/or ECMO, the duration of therapy is 10 days, beginning with a loading dose of remdesivir 200 mg infused intravenously for 30 to 120 minutes on day 1 followed by a once-daily dose of 100 mg for 9 days.
• Protocol 2: For people with COVID-19 disease not requiring mechanical ventilation and/or ECMO, the duration of therapy is 5 days, beginning with a loading dose of remdesivir 200 mg infused intravenously for 30 to 120 minutes on day 1 followed by a once-daily dose of 100 mg for 4 days. If the patient does not show clinical improvement, treatment may be extended for an additional 5 days. ​​​​​​

Continue to: Randomized placebo-controlled trial results...

Randomized placebo-controlled trial results

The Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the National Institute of Allergy and Infectious Diseases, is a randomized, double-blind, placebo-controlled trial conducted by Gilead Sciences. The study began in February and evaluated up to 10 days of remdesivir treatment—200 mg IV once daily for 1 day followed by 100 mg IV once daily for 9 days in hospitalized adult patients with COVID-19. Patients were enrolled in a 1:1 manner to remdesivir or placebo, and time to recovery within 28 days after randomization was the trial’s endpoint. According to preliminary analysis of 606 recovered patients, recovery took a median of 11 days in the remdesivir group and 15 days in the placebo group (hazard ratio, 1.31; 95% confidence interval (CI), 1.12‒1.54; P<.001). Mortality rates were 8.0% and 11.6% in the remdesivir and placebo groups, respectively (P=.059).¹

5 vs 10 days of remdesivir treatment

The Gilead Sciences‒sponsored study GS-US-540-5773 was a randomized, open-label multicenter trial of patients with severe COVID-19. A total of 197 adult patients received 10-day remdesivir treatment (200 mg IV once daily for 1 day followed by 100 mg IV once daily for 9 days). An additional 200 adult patients received 5-day remdesivir treatment (200 mg IV once daily followed by 100 mg IV for 4 days). Both groups also received standard of care. Results suggested that patients receiving 10 days of remdesivir had similar improvement in clinical status compared with those receiving a 5-day treatment course (10-to-5 day odds ratio, 0.76; 95% CI, 0.51‒1.13] on day 14).¹ Improvement in clinical status was defined as an improvement of 2 or more points from baseline on a predefined 7-point scale that ranged from hospital discharge to increasing levels of oxygen support to death. Clinical recovery was achieved if patients ceased the need for oxygen support or were discharged.¹

The time to clinical improvement for 50% of patients was similar in each treatment group (10 days in the 5-day group versus 11 days in the 10-day group). By day 14, observed clinical improvement rates were 65% and 54% in the 5- and 10-day treatment groups, respectively. Clinical recovery rates were 70% and 59% in the 5- and 10-day treatment groups and mortality rates were 8% and 11%.¹

Adverse events

The use of remdesivir is contraindicated in patients who are hypersensitive to the drug. Its infusion may cause hypotension, nausea, vomiting, diaphoresis, and shivering. If signs of a clinically significant infusion reaction are observed the infusion should be discontinued. As noted above, elevation in ALT levels occurs with remdesivir treatment.¹

Reporting serious adverse events. If a serious and unexpected adverse event occurs and appears to be associated with the use of remdesivir, the prescribing health care provider and/or the provider’s designee should complete and submit a MedWatch form to the FDA using one of the following methods¹:

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Return form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) to the FDA by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178)
• Gilead requests that all FDA MedWatch forms also be returned to Gilead Pharmacovigilance and Epidemiology: fax: 1-650-522-5477 726; e-mail: [email protected]

Continue to: Drug interactions...

Drug interactions

Remdesivir has not been evaluated for drug-drug interactions in humans. The clinical relevance of in vitro drug interactions also has not been established. According to the FDA, remdesivir is a substrate for the drug metabolizing enzymes CYP2C8, CYP2D6, and CYP3A4, and is a substrate for organic anion transporting polypeptides 1B1 (OAPT1B1) and P-glycoprotein (P-gp) transporters. In vitro, remdesivir inhibits CYP3A4, OATP1B1, OATP1B3, BSEP, MRP4, and NTCP.¹

Pregnancy risk summary

Remdesivir has not been studied adequately in pregnant women and only should be used during pregnancy if the potential benefit of the drug justifies the potential risk to both mother and fetus.

Nonclinical animal studies that included systemic exposure of the predominant circulating metabolite of remdesivir in pregnant rats and rabbits (at 4 times the recommended dose of human exposure) demonstrated no adverse effect on embryofetal development.¹

Breastfeeding

The only information regarding breastfeeding and remdesivir comes from animal studies. The drug and its metabolites were detected in the plasma of nursing rat pups whose mothers given intravenous remdesivir daily from gestation day 6 to lactation day 20. Measured on lactation day 10, remdesivir exposure in the pups was about 1% that of maternal exposure.¹

“Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions from the drug in breastfeeding infants, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for remdesivir and any potential adverse effects on the breastfed child from remdesivir or from the underlying maternal condition.”¹

On June 17, 1775, American colonists, defending a forward redoubt on Breed’s Hill, ran out of gunpowder, and their position was overrun by British troops. The Battle of Bunker Hill resulted in the death of 140 colonists and 226 British soldiers, setting the stage for major combat throughout the colonies. American colonists lacked many necessary weapons. They had almost no gunpowder, few field cannons, and no warships. Yet, they fought on with the weapons at hand for 6 long years.

In the spring of 2020, American society has been shaken by the COVID-19 pandemic. Hospitals have been overrun with thousands of people infected with the disease. Some hospitals are breaking under the crush of intensely ill people filling up and spilling out of intensive care units. We are in a war, fighting a viral disease with a limited supply of weapons. We do not have access to the most powerful medical munitions: easily available rapid testing, proven antiviral medications, and an effective vaccine. Nevertheless, clinicians and patients are courageous, and we will continue the fight with the limited weapons we have until the pandemic is brought to an end.

Who is infected with SARS-CoV-2?

Rapid high-fidelity testing for SARS-CoV-2 nucleic acid sequences would be the best approach to identifying people with COVID-19 disease. At the beginning of the pandemic, testing was strictly rationed because of lack of reagents and test swabs. Clinicians were permitted to test only a minority of people who had symptoms. Asymptomatic individuals were not eligible to be tested. This terribly flawed approach to screening permitted a vast army of SARS-CoV-2–positive asymptomatic and mildly symptomatic people to circulate unchecked in the general population, infecting dozens of other people, some of whom developed moderate or severe disease. The Centers for Disease Control and Prevention (CDC) has reported on 7 independent clusters of COVID-19 disease, each of which appear to have been caused by one asymptomatic infected individual.⁶ Another cluster of COVID-19 disease from China appears to have been caused by one asymptomatic infected individual.⁷ Based on limited data, it appears that there may be a 1- to 3-day window where an individual with COVID-19 may be asymptomatic and able to infect others. I suspect that we will soon discover, based on testing for the presence of high-titre anti SARS-CoV-2 antibodies, that many people with no history of illness and people with mild respiratory symptoms had an undiagnosed COVID-19 infection.

As testing capacity expands we likely will be testing all women, including asymptomatic women, before they arrive at the hospital for childbirth or gynecologic surgery, as well as all inpatients and women with respiratory symptoms having an ambulatory encounter.

With expanded testing capability, some pregnant women who were symptomatic and tested positive for SARS-CoV-2 have had sequential long-term follow-up testing. A frequent observation is that over one to two weeks the viral symptoms resolve and the nasopharyngeal test becomes negative for SARS-CoV-2 on multiple sequential tests, only to become positive at a later date. The cause of the positive-negative-negative-positive test results is unknown, but it raises the possibility that once a person tests positive for SARS-CoV-2, they may be able to transmit the infection over many weeks, even after viral symptoms resolve.

Continue to: COVID-19: Respiratory droplet or aerosol transmission?

COVID-19: Respiratory droplet or aerosol transmission?

Respiratory droplets are large particles (> 5 µm in diameter) that tend to be pulled to the ground or furniture surfaces by gravity. Respiratory droplets do not circulate in the air for an extended period of time. Droplet nuclei are small particles less than 5 µm in diameter. These small particles may become aerosolized and float through the air for an extended period of time. The CDC and WHO believe that under ordinary conditions, SARS-CoV-2 is transmitted through respiratory droplets and contact routes.² In an analysis of more than 75,000 COVID-19 cases in China there were no reports of transmission by aerosolized airborne virus. Therefore, under ordinary conditions, surgical masks, face shields, gowns, and gloves provide a high level of protection from infection.⁸

In contrast to the WHO’s perspective, Dr. Harvey Fineberg, Chair of the National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, wrote a letter to the federal Office of Science and Technology Policy warning that normal breathing might generate aerosolization of the SARS-CoV-2 virus and result in airborne transmission.⁹ A report from the University of Nebraska Medical Center supports the concept of airborne transmission of SARS-CoV-2. In a study of 13 patients with COVID-19, room surfaces, toilet facilities, and air had evidence of viral contamination.¹⁰ The investigators concluded that disease spreads through respiratory droplets, person-to-person touch, contaminated surfaces, and airborne routes. Other investigators also have reported that aersolization of SARS-CoV-2 may occur.¹¹ Professional societies recommend that all medical staff caring for potential or confirmed COVID-19 patients should use personal protective equipment (PPE), including respirators (N95 respirators) when available. Importantly, all medical staff should be trained in and adhere to proper donning and doffing of PPE. The controversy about the modes of transmission of SARS-CoV-2 will continue, but as clinicians we need to work within the constraints of the equipment we have.

Certain medical procedures and devices are known to generate aerosolization of respiratory secretions. These procedures and devices include: bronchoscopy, intubation, extubation, cardiopulmonary resuscitation, nebulization, high-flow oxygen masks, and continuous- and bilevel-positive airway pressure devices. When aerosols are generated during the care of a patient with COVID-19, surgical masks are not sufficient protection against infection. When an aerosol is generated maximal protection of health care workers from viral transmission requires use of a negative-pressure room and an N95 respirator or powered air-purifying respirator (PAPR) device. However, negative-pressure rooms, N95 masks, and PAPRs are in very short supply or are unavailable in some health systems. We are lucky at our hospital that all of the labor rooms can be configured to operate in a negative-pressure mode, limiting potential airborne spread of the virus on the unit. Many hospitals restrict the use of N95 masks to anesthesiologists, leaving nurses, ObGyns, and surgical technicians without the best protective equipment, risking their health. As one action to reduce aerosolization of virus, obstetricians can markedly reduce the use of oxygen masks and nasal cannulas by laboring women.

Universal use of surgical masks and mouth-nose coverings

During the entire COVID-19 pandemic, PPE has been in short supply, including severe shortages of N95 masks, PAPRs, and in some health systems, surgical masks, gowns, eye protection, and face shields. Given the severe shortages, some clinicians have needed to conserve PPE, using the same PPE across multiple patient encounters and across multiple work shifts.

Given that the virus is transmitted by respiratory droplets and contaminated surfaces, use of face coverings, including surgical masks, face shields, and gloves is critically important. Scrupulous hand hygiene is a simple approach to reducing infection risk. In my health system, all employees are required to wear a surgical mask, all day every day, requiring distribution of 35,000 masks daily.¹² We also require every patient and visitor to our health care facilities to use a face mask. The purpose of the procedure or surgical mask is to prevent presymptomatic spread of COVID-19 from an asymptomatic health care worker to an uninfected patient or a colleague by reducing the transmission of respiratory droplets. Another benefit is to protect the uninfected health care worker from patients and colleagues who are infected and not yet diagnosed with COVID-19. The CDC now recommends that all people wear a mouth and nose covering when they are outside of their residence. America may become a nation where wearing masks in public becomes a routine practice. Since SARS-CoV-2 is transmitted by respiratory droplets, social distancing is an important preventive measure.

Continue to: Obstetric care...

Obstetric care

Can it be repeated too often? No. Containing COVID-19 disease requires social distancing, fastidious hand hygiene, and using a mask that covers the mouth and nose.

Pregnant women should be advised to assiduously practice social distancing and to wear a face covering or mask in public. Hand hygiene should be emphasized. Pregnant women with children should be advised to not allow their children to play with non‒cohabiting children because children may be asymptomatic vectors for COVID-19.

Pregnant health care workers should stop face-to-face contact with patients after 36 weeks’ gestation to avoid a late pregnancy infection that might cause the mother to be separated from her newborn. Based on data currently available, pregnancy in the absence of another risk factor is not a major risk factor for developing severe COVID-19 disease.¹³

Hyperthermia is a common feature of COVID-19. Acetaminophen is recommended treatment to suppress pyrexia during pregnancy.

The COVID-19 pandemic has transformed prenatal care from a series of face-to-face encounters at a health care facility to telemedicine either by telephone or a videoconferencing portal. Many factors contributed to the rapid switch to telemedicine, including orders by governors to restrict unnecessary travel, patients’ fear of contracting COVID-19 at their clinicians’ offices, clinicians’ fear of contracting COVID-19 from patients, and insurers’ rapid implementation of policies to pay for telemedicine visits. Most prenatal visits can be provided through telemedicine as long as the patient has a home blood pressure cuff and can reliably use the instrument. In-person visits may be required for blood testing, ultrasound assessment, anti-Rh immunoglobulin administration, and group B streptococcal infection screening. One regimen is to limit in-person prenatal visits to encounters at 12, 20, 28, and 36 weeks’ gestation when blood testing and ultrasound examinations are needed. The postpartum visit also may be conducted using telemedicine.

Pregnant women with COVID-19 and pneumonia are reported to have high rates of preterm birth less than 37 weeks (41%) and preterm prelabor rupture of membranes (19%).¹⁴

The rate of vertical transmission from mother to fetus is probably very low (<1%).¹⁵ However, based on serological studies, an occasional newborn has been reported to have IgM and IgG antibodies to the SARS-CoV-2 nucleoprotein at birth.^16,17

Pregnant women should be consistently and regularly screened for symptoms of an upper respiratory infection, including: fever, new cough, new runny nose or nasal congestion, new sore throat, shortness of breath, muscle aches, and anosmia. A report of any of these symptoms should result in nucleic acid testing of a nasal swab for SARS-CoV-2 of all pregnant women. Given limited testing resources, however, symptomatic pregnant women with the following characteristics should be prioritized for testing: if the woman is more than 36 weeks pregnant, intrapartum, or in the hospital after delivery. Ambulatory pregnant women with symptoms who do not need medical care should quarantine themselves at home, if possible, or at another secure location away from their families. In some regions, testing of ambulatory patients with upper respiratory symptoms is limited.

All women scheduled for induction or cesarean delivery (CD) and their support person should have a symptom screen 24 to 48 hours before arrival to the hospital and should be rescreened prior to entry to labor and delivery. In this situation if the pregnant woman screens positive, she should be tested for SARS-CoV-2, and if the test result is positive, the scheduled induction and CD should be rescheduled, if possible. All hospitalized women and their support persons should be screened for symptoms daily. If the pregnant woman screens positive she should have a nucleic acid test for SARS-CoV-2. If the support person screens positive, he or she should be sent home.

Systemic glucocorticoids may worsen the course of COVID-19. For pregnant women with COVID-19 disease, betamethasone administration should be limited to women at high risk for preterm delivery within 7 days and only given to women between 23 weeks to 33 weeks 6 days of gestation. Women at risk for preterm delivery at 34 weeks to 36 weeks and 6 days of gestation should not be given betamethasone.

If cervical ripening is required, outpatient regimens should be prioritized.

One support person plays an important role in optimal labor outcome and should be permitted at the hospital. All support persons should wear a surgical or procedure mask.

Nitrous oxide for labor anesthesia should not be used during the pandemic because it might cause aerosolization of respiratory secretions, endangering health care workers. Neuraxial anesthesia is an optimal approach to labor anesthesia.

Labor management and timing of delivery does not need to be altered during the COVID-19 pandemic. However, pregnant women with moderate or severe COVID-19 disease who are not improving may have a modest improvement in respiratory function if they are delivered preterm.

At the beginning of the COVID pandemic, the CDC recommended separation of a COVID-positive mother and her newborn until the mother’s respiratory symptoms resolved. However, the CDC now recommends that, for a COVID-positive mother, joint decision-making should be used to decide whether to support the baby rooming-in with the mother or to practice separation of mother and baby at birth to reduce the risk for postnatal infection from mother to newborn. There is no evidence that breast milk contains virus that can cause an infection. One option is for the mother who recently tested positive for SARS-CoV-2 to provide newborn nutrition with expressed breast milk.

Pregnant women with COVID-19 may be at increased risk for venous thromboembolism. Some experts recommend that hospitalized pregnant women and postpartum women with COVID-19 receive thromboembolism prophylaxis.
The Chinese Centers for Disease Control and Prevention described a classification system for COVID-19 disease, including 3 categories¹⁸:

• mild: no dyspnea, no pneumonia, or mild pneumonia
• severe: dyspnea, respiratory frequency ≥ 30 breaths per minute, blood oxygen saturation ≤ 93%, lung infiltrates > 50% within 48 hours of onset of symptoms
• critical: respiratory failure, septic shock, or multiple organ dysfunction or failure.

Among 72,314 cases in China, 81% had mild disease, 14% had severe disease, and 5% had critical disease. In a report of 118 pregnant women in China, 92% of the women had mild disease; 8% had severe disease (hypoxemia), one of whom developed critical disease requiring mechanical ventilation.¹⁹ In this cohort, the most common presenting symptoms were fever (75%), cough (73%), chest tightness (18%), fatigue (17%), shortness of breath (7%), diarrhea (7%), and headache (6%). Lymphopenia was present in 44% of the women.

Severe and critical COVID-19 disease are associated with elevations in D-dimer, C-reactive protein, troponin, ferritin, and creatine phosphokinase levels. These markers return to the normal range with resolution of disease.

Continue to: Gynecologic care...

Gynecologic care

Gynecologists are highly impacted by the COVID-19 pandemic. Most state governments have requested that all elective surgery be suspended for the duration of the pandemic in order to redeploy health resources to the care of COVID-19 patients. Except for high-priority gynecologic surgery, including cancer surgery, treatment of heavy vaginal bleeding, and surgical care of ectopic pregnancy and miscarriage, most gynecologic surgery has ceased.

All office visits for routine gynecologic care have been suspended. Video and telephone visits can be used for contraceptive counseling and prescribing and for managing problems associated with the menopause, endometriosis, and vaginitis. Cervical cancer screening can be deferred for 3 to 6 months, depending on patient risk factors.

Medicines to treat COVID-19 infections

There are many highly effective medicines to manage HIV infection and medicines that cure hepatitis C. There is an urgent need to develop precision medicines to treat this disease. Early in the pandemic some experts thought that hydroxychloroquine might be helpful in the treatment of COVID-19 disease. But recent evidence suggests that hydroxychloroquine is probably not an effective treatment. As the pandemic has evolved, there is evidence that remdesivir may have modest efficacy in treating COVID-19 disease.²⁰ Remdesivir has received emergency-use authorization by the FDA to treat COVID-19 infection.

Remdesivir

Based on expert opinion, in the absence of high-quality clinical trial evidence, our current practice is to offer pregnant women with severe or critical COVID-19 disease treatment with remdesivir.

Remdesivir (Gilead Sciences, Inc) is a nucleoside analog that inhibits RNA synthesis. A dose regimen for remdesivir is a 200-mg loading dose given intravenously, followed by 100 mg daily given intravenously for 5 to 10 days. Remdesivir may cause elevation of hepatic enzymes. Remdesivir has been administered to a few pregnant women to treat Ebola and Marburg virus disease.²¹

Experts in infectious disease are important resources for determining optimal medication regimens for the treatment of COVID-19 disease in pregnant women.

Continue to: Convalescent serum...

Convalescent serum

There are no high-quality studies demonstrating the efficacy of convalescent serum for treatment of COVID-19. A small case series suggests that there may be modest benefit to treatment of people with severe COVID-19 disease with convalescent serum.²²

Testing for anti-SARS-CoV-2 IgM and IgG antibodies

We may have a serious problem in our current approach to detecting COVID-19 disease. Based on measurement of IgM and IgG antibodies to SARS-CoV-2 nucleocapsid protein, our current nucleic acid tests for SARS-CoV-2 may detect less than 80% of infections early in the course of disease. In two studies of IgM and IgG antibodies to the SARS-CoV-2 nucleocapsid protein, a single polymerase chain reaction test for SARS-CoV-2 had less than a 60% sensitivity for detecting the virus.^23,24 During the second week of COVID-19 illness, IgM or IgG antibodies were detected in greater than 89% of infected patients.²³ Severe disease resulted in high concentrations of antibody.

When testing for IgM and IgG antibodies is widely available, it may become an option to test all health care workers. This will permit the assignment of those health care workers with the highest levels of antibody to frontline duties with COVID-19 patients during the next disease outbreak, likely to occur at some point during the next 12 months.

A COVID-19 vaccine

Dozens of research teams, including pharmaceutical and biotechnology companies and many academic laboratories, are working on developing and testing vaccines to prevent COVID-19 disease. An effective vaccine would reduce the number of people who develop severe disease during the next outbreak, reducing deaths, avoiding a shutdown of the country, and allowing the health systems to function normally. A vaccine is unlikely to be widely available until sometime early in 2021.

Facing COVID-19 well-being and mental health

SARS-CoV-2, like all viral particles, is incredibly small. Remarkably, it has changed permanently life on earth. COVID-19 is affecting our physical health, psychological well-being, economics, and patterns of social interaction. As clinicians it is difficult to face a viral enemy that cannot be stopped from causing the death of more than 100,000 people, including some of our clinical colleagues, within a short period of time.

Dr. Russ Harris, an Australian acceptance commitment therapist, has written an ebook (http://www.commpsych.com/wp-content/uploads/FACE_COVID-1.pdf) and produced an animated YouTube video, titled FACE COVID (https://www.youtube.com/watch?v=BmvNCdpHUYM), which describes a systematic approach to deal with the challenge of the pandemic. He advises a 9-step approach:

• F—focus on what is in your control
• A—acknowledge your thoughts and feelings
• C—come back to a focus on your body
• E—engage in what you are doing
• C—commit to acting effectively based on your core values
• O—opening up to difficult feelings and being kind to yourself and others
• V—values should guide your actions
• I—identify resources for help, assistance, support, and advice
• D—disinfect and practice social distancing.

This war will come to an end

During the American Revolution, colonists faced housing and food insecurity, epidemics of typhus and smallpox, traumatic injury including amputation of limbs, and a complete disruption of normal life activities. They persevered and, against the odds, successfully concluded the war. Unlike the colonists, who did not know if their conflict would end with success or failure, we clinicians know that the COVID-19 pandemic will end. We also know that eventually the global community of clinicians will develop and deploy the effective weapons we need to prevent a recurrence of this traumatic pandemic: population-wide testing for both the SARS-CoV-2 virus and serologic testing for IgG and IgM antibodies to the virus, effective antiviral medications, and a potent vaccine. ●

On June 17, 1775, American colonists, defending a forward redoubt on Breed’s Hill, ran out of gunpowder, and their position was overrun by British troops. The Battle of Bunker Hill resulted in the death of 140 colonists and 226 British soldiers, setting the stage for major combat throughout the colonies. American colonists lacked many necessary weapons. They had almost no gunpowder, few field cannons, and no warships. Yet, they fought on with the weapons at hand for 6 long years.

In the spring of 2020, American society has been shaken by the COVID-19 pandemic. Hospitals have been overrun with thousands of people infected with the disease. Some hospitals are breaking under the crush of intensely ill people filling up and spilling out of intensive care units. We are in a war, fighting a viral disease with a limited supply of weapons. We do not have access to the most powerful medical munitions: easily available rapid testing, proven antiviral medications, and an effective vaccine. Nevertheless, clinicians and patients are courageous, and we will continue the fight with the limited weapons we have until the pandemic is brought to an end.

Who is infected with SARS-CoV-2?

Rapid high-fidelity testing for SARS-CoV-2 nucleic acid sequences would be the best approach to identifying people with COVID-19 disease. At the beginning of the pandemic, testing was strictly rationed because of lack of reagents and test swabs. Clinicians were permitted to test only a minority of people who had symptoms. Asymptomatic individuals were not eligible to be tested. This terribly flawed approach to screening permitted a vast army of SARS-CoV-2–positive asymptomatic and mildly symptomatic people to circulate unchecked in the general population, infecting dozens of other people, some of whom developed moderate or severe disease. The Centers for Disease Control and Prevention (CDC) has reported on 7 independent clusters of COVID-19 disease, each of which appear to have been caused by one asymptomatic infected individual.⁶ Another cluster of COVID-19 disease from China appears to have been caused by one asymptomatic infected individual.⁷ Based on limited data, it appears that there may be a 1- to 3-day window where an individual with COVID-19 may be asymptomatic and able to infect others. I suspect that we will soon discover, based on testing for the presence of high-titre anti SARS-CoV-2 antibodies, that many people with no history of illness and people with mild respiratory symptoms had an undiagnosed COVID-19 infection.

As testing capacity expands we likely will be testing all women, including asymptomatic women, before they arrive at the hospital for childbirth or gynecologic surgery, as well as all inpatients and women with respiratory symptoms having an ambulatory encounter.

With expanded testing capability, some pregnant women who were symptomatic and tested positive for SARS-CoV-2 have had sequential long-term follow-up testing. A frequent observation is that over one to two weeks the viral symptoms resolve and the nasopharyngeal test becomes negative for SARS-CoV-2 on multiple sequential tests, only to become positive at a later date. The cause of the positive-negative-negative-positive test results is unknown, but it raises the possibility that once a person tests positive for SARS-CoV-2, they may be able to transmit the infection over many weeks, even after viral symptoms resolve.

Continue to: COVID-19: Respiratory droplet or aerosol transmission?

COVID-19: Respiratory droplet or aerosol transmission?

Respiratory droplets are large particles (> 5 µm in diameter) that tend to be pulled to the ground or furniture surfaces by gravity. Respiratory droplets do not circulate in the air for an extended period of time. Droplet nuclei are small particles less than 5 µm in diameter. These small particles may become aerosolized and float through the air for an extended period of time. The CDC and WHO believe that under ordinary conditions, SARS-CoV-2 is transmitted through respiratory droplets and contact routes.² In an analysis of more than 75,000 COVID-19 cases in China there were no reports of transmission by aerosolized airborne virus. Therefore, under ordinary conditions, surgical masks, face shields, gowns, and gloves provide a high level of protection from infection.⁸

In contrast to the WHO’s perspective, Dr. Harvey Fineberg, Chair of the National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, wrote a letter to the federal Office of Science and Technology Policy warning that normal breathing might generate aerosolization of the SARS-CoV-2 virus and result in airborne transmission.⁹ A report from the University of Nebraska Medical Center supports the concept of airborne transmission of SARS-CoV-2. In a study of 13 patients with COVID-19, room surfaces, toilet facilities, and air had evidence of viral contamination.¹⁰ The investigators concluded that disease spreads through respiratory droplets, person-to-person touch, contaminated surfaces, and airborne routes. Other investigators also have reported that aersolization of SARS-CoV-2 may occur.¹¹ Professional societies recommend that all medical staff caring for potential or confirmed COVID-19 patients should use personal protective equipment (PPE), including respirators (N95 respirators) when available. Importantly, all medical staff should be trained in and adhere to proper donning and doffing of PPE. The controversy about the modes of transmission of SARS-CoV-2 will continue, but as clinicians we need to work within the constraints of the equipment we have.

Certain medical procedures and devices are known to generate aerosolization of respiratory secretions. These procedures and devices include: bronchoscopy, intubation, extubation, cardiopulmonary resuscitation, nebulization, high-flow oxygen masks, and continuous- and bilevel-positive airway pressure devices. When aerosols are generated during the care of a patient with COVID-19, surgical masks are not sufficient protection against infection. When an aerosol is generated maximal protection of health care workers from viral transmission requires use of a negative-pressure room and an N95 respirator or powered air-purifying respirator (PAPR) device. However, negative-pressure rooms, N95 masks, and PAPRs are in very short supply or are unavailable in some health systems. We are lucky at our hospital that all of the labor rooms can be configured to operate in a negative-pressure mode, limiting potential airborne spread of the virus on the unit. Many hospitals restrict the use of N95 masks to anesthesiologists, leaving nurses, ObGyns, and surgical technicians without the best protective equipment, risking their health. As one action to reduce aerosolization of virus, obstetricians can markedly reduce the use of oxygen masks and nasal cannulas by laboring women.

Universal use of surgical masks and mouth-nose coverings

During the entire COVID-19 pandemic, PPE has been in short supply, including severe shortages of N95 masks, PAPRs, and in some health systems, surgical masks, gowns, eye protection, and face shields. Given the severe shortages, some clinicians have needed to conserve PPE, using the same PPE across multiple patient encounters and across multiple work shifts.

Given that the virus is transmitted by respiratory droplets and contaminated surfaces, use of face coverings, including surgical masks, face shields, and gloves is critically important. Scrupulous hand hygiene is a simple approach to reducing infection risk. In my health system, all employees are required to wear a surgical mask, all day every day, requiring distribution of 35,000 masks daily.¹² We also require every patient and visitor to our health care facilities to use a face mask. The purpose of the procedure or surgical mask is to prevent presymptomatic spread of COVID-19 from an asymptomatic health care worker to an uninfected patient or a colleague by reducing the transmission of respiratory droplets. Another benefit is to protect the uninfected health care worker from patients and colleagues who are infected and not yet diagnosed with COVID-19. The CDC now recommends that all people wear a mouth and nose covering when they are outside of their residence. America may become a nation where wearing masks in public becomes a routine practice. Since SARS-CoV-2 is transmitted by respiratory droplets, social distancing is an important preventive measure.

Continue to: Obstetric care...

Obstetric care

Can it be repeated too often? No. Containing COVID-19 disease requires social distancing, fastidious hand hygiene, and using a mask that covers the mouth and nose.

Pregnant women should be advised to assiduously practice social distancing and to wear a face covering or mask in public. Hand hygiene should be emphasized. Pregnant women with children should be advised to not allow their children to play with non‒cohabiting children because children may be asymptomatic vectors for COVID-19.

Pregnant health care workers should stop face-to-face contact with patients after 36 weeks’ gestation to avoid a late pregnancy infection that might cause the mother to be separated from her newborn. Based on data currently available, pregnancy in the absence of another risk factor is not a major risk factor for developing severe COVID-19 disease.¹³

Hyperthermia is a common feature of COVID-19. Acetaminophen is recommended treatment to suppress pyrexia during pregnancy.

The COVID-19 pandemic has transformed prenatal care from a series of face-to-face encounters at a health care facility to telemedicine either by telephone or a videoconferencing portal. Many factors contributed to the rapid switch to telemedicine, including orders by governors to restrict unnecessary travel, patients’ fear of contracting COVID-19 at their clinicians’ offices, clinicians’ fear of contracting COVID-19 from patients, and insurers’ rapid implementation of policies to pay for telemedicine visits. Most prenatal visits can be provided through telemedicine as long as the patient has a home blood pressure cuff and can reliably use the instrument. In-person visits may be required for blood testing, ultrasound assessment, anti-Rh immunoglobulin administration, and group B streptococcal infection screening. One regimen is to limit in-person prenatal visits to encounters at 12, 20, 28, and 36 weeks’ gestation when blood testing and ultrasound examinations are needed. The postpartum visit also may be conducted using telemedicine.

Pregnant women with COVID-19 and pneumonia are reported to have high rates of preterm birth less than 37 weeks (41%) and preterm prelabor rupture of membranes (19%).¹⁴

The rate of vertical transmission from mother to fetus is probably very low (<1%).¹⁵ However, based on serological studies, an occasional newborn has been reported to have IgM and IgG antibodies to the SARS-CoV-2 nucleoprotein at birth.^16,17

Pregnant women should be consistently and regularly screened for symptoms of an upper respiratory infection, including: fever, new cough, new runny nose or nasal congestion, new sore throat, shortness of breath, muscle aches, and anosmia. A report of any of these symptoms should result in nucleic acid testing of a nasal swab for SARS-CoV-2 of all pregnant women. Given limited testing resources, however, symptomatic pregnant women with the following characteristics should be prioritized for testing: if the woman is more than 36 weeks pregnant, intrapartum, or in the hospital after delivery. Ambulatory pregnant women with symptoms who do not need medical care should quarantine themselves at home, if possible, or at another secure location away from their families. In some regions, testing of ambulatory patients with upper respiratory symptoms is limited.

All women scheduled for induction or cesarean delivery (CD) and their support person should have a symptom screen 24 to 48 hours before arrival to the hospital and should be rescreened prior to entry to labor and delivery. In this situation if the pregnant woman screens positive, she should be tested for SARS-CoV-2, and if the test result is positive, the scheduled induction and CD should be rescheduled, if possible. All hospitalized women and their support persons should be screened for symptoms daily. If the pregnant woman screens positive she should have a nucleic acid test for SARS-CoV-2. If the support person screens positive, he or she should be sent home.

Systemic glucocorticoids may worsen the course of COVID-19. For pregnant women with COVID-19 disease, betamethasone administration should be limited to women at high risk for preterm delivery within 7 days and only given to women between 23 weeks to 33 weeks 6 days of gestation. Women at risk for preterm delivery at 34 weeks to 36 weeks and 6 days of gestation should not be given betamethasone.

If cervical ripening is required, outpatient regimens should be prioritized.

One support person plays an important role in optimal labor outcome and should be permitted at the hospital. All support persons should wear a surgical or procedure mask.

Nitrous oxide for labor anesthesia should not be used during the pandemic because it might cause aerosolization of respiratory secretions, endangering health care workers. Neuraxial anesthesia is an optimal approach to labor anesthesia.

Labor management and timing of delivery does not need to be altered during the COVID-19 pandemic. However, pregnant women with moderate or severe COVID-19 disease who are not improving may have a modest improvement in respiratory function if they are delivered preterm.

At the beginning of the COVID pandemic, the CDC recommended separation of a COVID-positive mother and her newborn until the mother’s respiratory symptoms resolved. However, the CDC now recommends that, for a COVID-positive mother, joint decision-making should be used to decide whether to support the baby rooming-in with the mother or to practice separation of mother and baby at birth to reduce the risk for postnatal infection from mother to newborn. There is no evidence that breast milk contains virus that can cause an infection. One option is for the mother who recently tested positive for SARS-CoV-2 to provide newborn nutrition with expressed breast milk.

Pregnant women with COVID-19 may be at increased risk for venous thromboembolism. Some experts recommend that hospitalized pregnant women and postpartum women with COVID-19 receive thromboembolism prophylaxis.
The Chinese Centers for Disease Control and Prevention described a classification system for COVID-19 disease, including 3 categories¹⁸:

• mild: no dyspnea, no pneumonia, or mild pneumonia
• severe: dyspnea, respiratory frequency ≥ 30 breaths per minute, blood oxygen saturation ≤ 93%, lung infiltrates > 50% within 48 hours of onset of symptoms
• critical: respiratory failure, septic shock, or multiple organ dysfunction or failure.

Among 72,314 cases in China, 81% had mild disease, 14% had severe disease, and 5% had critical disease. In a report of 118 pregnant women in China, 92% of the women had mild disease; 8% had severe disease (hypoxemia), one of whom developed critical disease requiring mechanical ventilation.¹⁹ In this cohort, the most common presenting symptoms were fever (75%), cough (73%), chest tightness (18%), fatigue (17%), shortness of breath (7%), diarrhea (7%), and headache (6%). Lymphopenia was present in 44% of the women.

Severe and critical COVID-19 disease are associated with elevations in D-dimer, C-reactive protein, troponin, ferritin, and creatine phosphokinase levels. These markers return to the normal range with resolution of disease.

Continue to: Gynecologic care...

Gynecologic care

Gynecologists are highly impacted by the COVID-19 pandemic. Most state governments have requested that all elective surgery be suspended for the duration of the pandemic in order to redeploy health resources to the care of COVID-19 patients. Except for high-priority gynecologic surgery, including cancer surgery, treatment of heavy vaginal bleeding, and surgical care of ectopic pregnancy and miscarriage, most gynecologic surgery has ceased.

All office visits for routine gynecologic care have been suspended. Video and telephone visits can be used for contraceptive counseling and prescribing and for managing problems associated with the menopause, endometriosis, and vaginitis. Cervical cancer screening can be deferred for 3 to 6 months, depending on patient risk factors.

Medicines to treat COVID-19 infections

There are many highly effective medicines to manage HIV infection and medicines that cure hepatitis C. There is an urgent need to develop precision medicines to treat this disease. Early in the pandemic some experts thought that hydroxychloroquine might be helpful in the treatment of COVID-19 disease. But recent evidence suggests that hydroxychloroquine is probably not an effective treatment. As the pandemic has evolved, there is evidence that remdesivir may have modest efficacy in treating COVID-19 disease.²⁰ Remdesivir has received emergency-use authorization by the FDA to treat COVID-19 infection.

Remdesivir

Based on expert opinion, in the absence of high-quality clinical trial evidence, our current practice is to offer pregnant women with severe or critical COVID-19 disease treatment with remdesivir.

Remdesivir (Gilead Sciences, Inc) is a nucleoside analog that inhibits RNA synthesis. A dose regimen for remdesivir is a 200-mg loading dose given intravenously, followed by 100 mg daily given intravenously for 5 to 10 days. Remdesivir may cause elevation of hepatic enzymes. Remdesivir has been administered to a few pregnant women to treat Ebola and Marburg virus disease.²¹

Experts in infectious disease are important resources for determining optimal medication regimens for the treatment of COVID-19 disease in pregnant women.

Continue to: Convalescent serum...

Convalescent serum

There are no high-quality studies demonstrating the efficacy of convalescent serum for treatment of COVID-19. A small case series suggests that there may be modest benefit to treatment of people with severe COVID-19 disease with convalescent serum.²²

Testing for anti-SARS-CoV-2 IgM and IgG antibodies

We may have a serious problem in our current approach to detecting COVID-19 disease. Based on measurement of IgM and IgG antibodies to SARS-CoV-2 nucleocapsid protein, our current nucleic acid tests for SARS-CoV-2 may detect less than 80% of infections early in the course of disease. In two studies of IgM and IgG antibodies to the SARS-CoV-2 nucleocapsid protein, a single polymerase chain reaction test for SARS-CoV-2 had less than a 60% sensitivity for detecting the virus.^23,24 During the second week of COVID-19 illness, IgM or IgG antibodies were detected in greater than 89% of infected patients.²³ Severe disease resulted in high concentrations of antibody.

When testing for IgM and IgG antibodies is widely available, it may become an option to test all health care workers. This will permit the assignment of those health care workers with the highest levels of antibody to frontline duties with COVID-19 patients during the next disease outbreak, likely to occur at some point during the next 12 months.

A COVID-19 vaccine

Dozens of research teams, including pharmaceutical and biotechnology companies and many academic laboratories, are working on developing and testing vaccines to prevent COVID-19 disease. An effective vaccine would reduce the number of people who develop severe disease during the next outbreak, reducing deaths, avoiding a shutdown of the country, and allowing the health systems to function normally. A vaccine is unlikely to be widely available until sometime early in 2021.

Facing COVID-19 well-being and mental health

SARS-CoV-2, like all viral particles, is incredibly small. Remarkably, it has changed permanently life on earth. COVID-19 is affecting our physical health, psychological well-being, economics, and patterns of social interaction. As clinicians it is difficult to face a viral enemy that cannot be stopped from causing the death of more than 100,000 people, including some of our clinical colleagues, within a short period of time.

Dr. Russ Harris, an Australian acceptance commitment therapist, has written an ebook (http://www.commpsych.com/wp-content/uploads/FACE_COVID-1.pdf) and produced an animated YouTube video, titled FACE COVID (https://www.youtube.com/watch?v=BmvNCdpHUYM), which describes a systematic approach to deal with the challenge of the pandemic. He advises a 9-step approach:

• F—focus on what is in your control
• A—acknowledge your thoughts and feelings
• C—come back to a focus on your body
• E—engage in what you are doing
• C—commit to acting effectively based on your core values
• O—opening up to difficult feelings and being kind to yourself and others
• V—values should guide your actions
• I—identify resources for help, assistance, support, and advice
• D—disinfect and practice social distancing.

This war will come to an end

During the American Revolution, colonists faced housing and food insecurity, epidemics of typhus and smallpox, traumatic injury including amputation of limbs, and a complete disruption of normal life activities. They persevered and, against the odds, successfully concluded the war. Unlike the colonists, who did not know if their conflict would end with success or failure, we clinicians know that the COVID-19 pandemic will end. We also know that eventually the global community of clinicians will develop and deploy the effective weapons we need to prevent a recurrence of this traumatic pandemic: population-wide testing for both the SARS-CoV-2 virus and serologic testing for IgG and IgM antibodies to the virus, effective antiviral medications, and a potent vaccine. ●

On June 17, 1775, American colonists, defending a forward redoubt on Breed’s Hill, ran out of gunpowder, and their position was overrun by British troops. The Battle of Bunker Hill resulted in the death of 140 colonists and 226 British soldiers, setting the stage for major combat throughout the colonies. American colonists lacked many necessary weapons. They had almost no gunpowder, few field cannons, and no warships. Yet, they fought on with the weapons at hand for 6 long years.

In the spring of 2020, American society has been shaken by the COVID-19 pandemic. Hospitals have been overrun with thousands of people infected with the disease. Some hospitals are breaking under the crush of intensely ill people filling up and spilling out of intensive care units. We are in a war, fighting a viral disease with a limited supply of weapons. We do not have access to the most powerful medical munitions: easily available rapid testing, proven antiviral medications, and an effective vaccine. Nevertheless, clinicians and patients are courageous, and we will continue the fight with the limited weapons we have until the pandemic is brought to an end.

Who is infected with SARS-CoV-2?

Rapid high-fidelity testing for SARS-CoV-2 nucleic acid sequences would be the best approach to identifying people with COVID-19 disease. At the beginning of the pandemic, testing was strictly rationed because of lack of reagents and test swabs. Clinicians were permitted to test only a minority of people who had symptoms. Asymptomatic individuals were not eligible to be tested. This terribly flawed approach to screening permitted a vast army of SARS-CoV-2–positive asymptomatic and mildly symptomatic people to circulate unchecked in the general population, infecting dozens of other people, some of whom developed moderate or severe disease. The Centers for Disease Control and Prevention (CDC) has reported on 7 independent clusters of COVID-19 disease, each of which appear to have been caused by one asymptomatic infected individual.⁶ Another cluster of COVID-19 disease from China appears to have been caused by one asymptomatic infected individual.⁷ Based on limited data, it appears that there may be a 1- to 3-day window where an individual with COVID-19 may be asymptomatic and able to infect others. I suspect that we will soon discover, based on testing for the presence of high-titre anti SARS-CoV-2 antibodies, that many people with no history of illness and people with mild respiratory symptoms had an undiagnosed COVID-19 infection.

As testing capacity expands we likely will be testing all women, including asymptomatic women, before they arrive at the hospital for childbirth or gynecologic surgery, as well as all inpatients and women with respiratory symptoms having an ambulatory encounter.

With expanded testing capability, some pregnant women who were symptomatic and tested positive for SARS-CoV-2 have had sequential long-term follow-up testing. A frequent observation is that over one to two weeks the viral symptoms resolve and the nasopharyngeal test becomes negative for SARS-CoV-2 on multiple sequential tests, only to become positive at a later date. The cause of the positive-negative-negative-positive test results is unknown, but it raises the possibility that once a person tests positive for SARS-CoV-2, they may be able to transmit the infection over many weeks, even after viral symptoms resolve.

Continue to: COVID-19: Respiratory droplet or aerosol transmission?

COVID-19: Respiratory droplet or aerosol transmission?

Respiratory droplets are large particles (> 5 µm in diameter) that tend to be pulled to the ground or furniture surfaces by gravity. Respiratory droplets do not circulate in the air for an extended period of time. Droplet nuclei are small particles less than 5 µm in diameter. These small particles may become aerosolized and float through the air for an extended period of time. The CDC and WHO believe that under ordinary conditions, SARS-CoV-2 is transmitted through respiratory droplets and contact routes.² In an analysis of more than 75,000 COVID-19 cases in China there were no reports of transmission by aerosolized airborne virus. Therefore, under ordinary conditions, surgical masks, face shields, gowns, and gloves provide a high level of protection from infection.⁸

In contrast to the WHO’s perspective, Dr. Harvey Fineberg, Chair of the National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, wrote a letter to the federal Office of Science and Technology Policy warning that normal breathing might generate aerosolization of the SARS-CoV-2 virus and result in airborne transmission.⁹ A report from the University of Nebraska Medical Center supports the concept of airborne transmission of SARS-CoV-2. In a study of 13 patients with COVID-19, room surfaces, toilet facilities, and air had evidence of viral contamination.¹⁰ The investigators concluded that disease spreads through respiratory droplets, person-to-person touch, contaminated surfaces, and airborne routes. Other investigators also have reported that aersolization of SARS-CoV-2 may occur.¹¹ Professional societies recommend that all medical staff caring for potential or confirmed COVID-19 patients should use personal protective equipment (PPE), including respirators (N95 respirators) when available. Importantly, all medical staff should be trained in and adhere to proper donning and doffing of PPE. The controversy about the modes of transmission of SARS-CoV-2 will continue, but as clinicians we need to work within the constraints of the equipment we have.

Certain medical procedures and devices are known to generate aerosolization of respiratory secretions. These procedures and devices include: bronchoscopy, intubation, extubation, cardiopulmonary resuscitation, nebulization, high-flow oxygen masks, and continuous- and bilevel-positive airway pressure devices. When aerosols are generated during the care of a patient with COVID-19, surgical masks are not sufficient protection against infection. When an aerosol is generated maximal protection of health care workers from viral transmission requires use of a negative-pressure room and an N95 respirator or powered air-purifying respirator (PAPR) device. However, negative-pressure rooms, N95 masks, and PAPRs are in very short supply or are unavailable in some health systems. We are lucky at our hospital that all of the labor rooms can be configured to operate in a negative-pressure mode, limiting potential airborne spread of the virus on the unit. Many hospitals restrict the use of N95 masks to anesthesiologists, leaving nurses, ObGyns, and surgical technicians without the best protective equipment, risking their health. As one action to reduce aerosolization of virus, obstetricians can markedly reduce the use of oxygen masks and nasal cannulas by laboring women.

Universal use of surgical masks and mouth-nose coverings

During the entire COVID-19 pandemic, PPE has been in short supply, including severe shortages of N95 masks, PAPRs, and in some health systems, surgical masks, gowns, eye protection, and face shields. Given the severe shortages, some clinicians have needed to conserve PPE, using the same PPE across multiple patient encounters and across multiple work shifts.

Given that the virus is transmitted by respiratory droplets and contaminated surfaces, use of face coverings, including surgical masks, face shields, and gloves is critically important. Scrupulous hand hygiene is a simple approach to reducing infection risk. In my health system, all employees are required to wear a surgical mask, all day every day, requiring distribution of 35,000 masks daily.¹² We also require every patient and visitor to our health care facilities to use a face mask. The purpose of the procedure or surgical mask is to prevent presymptomatic spread of COVID-19 from an asymptomatic health care worker to an uninfected patient or a colleague by reducing the transmission of respiratory droplets. Another benefit is to protect the uninfected health care worker from patients and colleagues who are infected and not yet diagnosed with COVID-19. The CDC now recommends that all people wear a mouth and nose covering when they are outside of their residence. America may become a nation where wearing masks in public becomes a routine practice. Since SARS-CoV-2 is transmitted by respiratory droplets, social distancing is an important preventive measure.

Continue to: Obstetric care...

Obstetric care

Can it be repeated too often? No. Containing COVID-19 disease requires social distancing, fastidious hand hygiene, and using a mask that covers the mouth and nose.

Pregnant women should be advised to assiduously practice social distancing and to wear a face covering or mask in public. Hand hygiene should be emphasized. Pregnant women with children should be advised to not allow their children to play with non‒cohabiting children because children may be asymptomatic vectors for COVID-19.

Pregnant health care workers should stop face-to-face contact with patients after 36 weeks’ gestation to avoid a late pregnancy infection that might cause the mother to be separated from her newborn. Based on data currently available, pregnancy in the absence of another risk factor is not a major risk factor for developing severe COVID-19 disease.¹³

Hyperthermia is a common feature of COVID-19. Acetaminophen is recommended treatment to suppress pyrexia during pregnancy.

The COVID-19 pandemic has transformed prenatal care from a series of face-to-face encounters at a health care facility to telemedicine either by telephone or a videoconferencing portal. Many factors contributed to the rapid switch to telemedicine, including orders by governors to restrict unnecessary travel, patients’ fear of contracting COVID-19 at their clinicians’ offices, clinicians’ fear of contracting COVID-19 from patients, and insurers’ rapid implementation of policies to pay for telemedicine visits. Most prenatal visits can be provided through telemedicine as long as the patient has a home blood pressure cuff and can reliably use the instrument. In-person visits may be required for blood testing, ultrasound assessment, anti-Rh immunoglobulin administration, and group B streptococcal infection screening. One regimen is to limit in-person prenatal visits to encounters at 12, 20, 28, and 36 weeks’ gestation when blood testing and ultrasound examinations are needed. The postpartum visit also may be conducted using telemedicine.

Pregnant women with COVID-19 and pneumonia are reported to have high rates of preterm birth less than 37 weeks (41%) and preterm prelabor rupture of membranes (19%).¹⁴

The rate of vertical transmission from mother to fetus is probably very low (<1%).¹⁵ However, based on serological studies, an occasional newborn has been reported to have IgM and IgG antibodies to the SARS-CoV-2 nucleoprotein at birth.^16,17

Pregnant women should be consistently and regularly screened for symptoms of an upper respiratory infection, including: fever, new cough, new runny nose or nasal congestion, new sore throat, shortness of breath, muscle aches, and anosmia. A report of any of these symptoms should result in nucleic acid testing of a nasal swab for SARS-CoV-2 of all pregnant women. Given limited testing resources, however, symptomatic pregnant women with the following characteristics should be prioritized for testing: if the woman is more than 36 weeks pregnant, intrapartum, or in the hospital after delivery. Ambulatory pregnant women with symptoms who do not need medical care should quarantine themselves at home, if possible, or at another secure location away from their families. In some regions, testing of ambulatory patients with upper respiratory symptoms is limited.

All women scheduled for induction or cesarean delivery (CD) and their support person should have a symptom screen 24 to 48 hours before arrival to the hospital and should be rescreened prior to entry to labor and delivery. In this situation if the pregnant woman screens positive, she should be tested for SARS-CoV-2, and if the test result is positive, the scheduled induction and CD should be rescheduled, if possible. All hospitalized women and their support persons should be screened for symptoms daily. If the pregnant woman screens positive she should have a nucleic acid test for SARS-CoV-2. If the support person screens positive, he or she should be sent home.

Systemic glucocorticoids may worsen the course of COVID-19. For pregnant women with COVID-19 disease, betamethasone administration should be limited to women at high risk for preterm delivery within 7 days and only given to women between 23 weeks to 33 weeks 6 days of gestation. Women at risk for preterm delivery at 34 weeks to 36 weeks and 6 days of gestation should not be given betamethasone.

If cervical ripening is required, outpatient regimens should be prioritized.

One support person plays an important role in optimal labor outcome and should be permitted at the hospital. All support persons should wear a surgical or procedure mask.

Nitrous oxide for labor anesthesia should not be used during the pandemic because it might cause aerosolization of respiratory secretions, endangering health care workers. Neuraxial anesthesia is an optimal approach to labor anesthesia.

Labor management and timing of delivery does not need to be altered during the COVID-19 pandemic. However, pregnant women with moderate or severe COVID-19 disease who are not improving may have a modest improvement in respiratory function if they are delivered preterm.

At the beginning of the COVID pandemic, the CDC recommended separation of a COVID-positive mother and her newborn until the mother’s respiratory symptoms resolved. However, the CDC now recommends that, for a COVID-positive mother, joint decision-making should be used to decide whether to support the baby rooming-in with the mother or to practice separation of mother and baby at birth to reduce the risk for postnatal infection from mother to newborn. There is no evidence that breast milk contains virus that can cause an infection. One option is for the mother who recently tested positive for SARS-CoV-2 to provide newborn nutrition with expressed breast milk.

Pregnant women with COVID-19 may be at increased risk for venous thromboembolism. Some experts recommend that hospitalized pregnant women and postpartum women with COVID-19 receive thromboembolism prophylaxis.
The Chinese Centers for Disease Control and Prevention described a classification system for COVID-19 disease, including 3 categories¹⁸:

• mild: no dyspnea, no pneumonia, or mild pneumonia
• severe: dyspnea, respiratory frequency ≥ 30 breaths per minute, blood oxygen saturation ≤ 93%, lung infiltrates > 50% within 48 hours of onset of symptoms
• critical: respiratory failure, septic shock, or multiple organ dysfunction or failure.

Among 72,314 cases in China, 81% had mild disease, 14% had severe disease, and 5% had critical disease. In a report of 118 pregnant women in China, 92% of the women had mild disease; 8% had severe disease (hypoxemia), one of whom developed critical disease requiring mechanical ventilation.¹⁹ In this cohort, the most common presenting symptoms were fever (75%), cough (73%), chest tightness (18%), fatigue (17%), shortness of breath (7%), diarrhea (7%), and headache (6%). Lymphopenia was present in 44% of the women.

Severe and critical COVID-19 disease are associated with elevations in D-dimer, C-reactive protein, troponin, ferritin, and creatine phosphokinase levels. These markers return to the normal range with resolution of disease.

Continue to: Gynecologic care...

Gynecologic care

Gynecologists are highly impacted by the COVID-19 pandemic. Most state governments have requested that all elective surgery be suspended for the duration of the pandemic in order to redeploy health resources to the care of COVID-19 patients. Except for high-priority gynecologic surgery, including cancer surgery, treatment of heavy vaginal bleeding, and surgical care of ectopic pregnancy and miscarriage, most gynecologic surgery has ceased.

All office visits for routine gynecologic care have been suspended. Video and telephone visits can be used for contraceptive counseling and prescribing and for managing problems associated with the menopause, endometriosis, and vaginitis. Cervical cancer screening can be deferred for 3 to 6 months, depending on patient risk factors.

Medicines to treat COVID-19 infections

There are many highly effective medicines to manage HIV infection and medicines that cure hepatitis C. There is an urgent need to develop precision medicines to treat this disease. Early in the pandemic some experts thought that hydroxychloroquine might be helpful in the treatment of COVID-19 disease. But recent evidence suggests that hydroxychloroquine is probably not an effective treatment. As the pandemic has evolved, there is evidence that remdesivir may have modest efficacy in treating COVID-19 disease.²⁰ Remdesivir has received emergency-use authorization by the FDA to treat COVID-19 infection.

Remdesivir

Based on expert opinion, in the absence of high-quality clinical trial evidence, our current practice is to offer pregnant women with severe or critical COVID-19 disease treatment with remdesivir.

Remdesivir (Gilead Sciences, Inc) is a nucleoside analog that inhibits RNA synthesis. A dose regimen for remdesivir is a 200-mg loading dose given intravenously, followed by 100 mg daily given intravenously for 5 to 10 days. Remdesivir may cause elevation of hepatic enzymes. Remdesivir has been administered to a few pregnant women to treat Ebola and Marburg virus disease.²¹

Experts in infectious disease are important resources for determining optimal medication regimens for the treatment of COVID-19 disease in pregnant women.

Continue to: Convalescent serum...

Convalescent serum

There are no high-quality studies demonstrating the efficacy of convalescent serum for treatment of COVID-19. A small case series suggests that there may be modest benefit to treatment of people with severe COVID-19 disease with convalescent serum.²²

Testing for anti-SARS-CoV-2 IgM and IgG antibodies

We may have a serious problem in our current approach to detecting COVID-19 disease. Based on measurement of IgM and IgG antibodies to SARS-CoV-2 nucleocapsid protein, our current nucleic acid tests for SARS-CoV-2 may detect less than 80% of infections early in the course of disease. In two studies of IgM and IgG antibodies to the SARS-CoV-2 nucleocapsid protein, a single polymerase chain reaction test for SARS-CoV-2 had less than a 60% sensitivity for detecting the virus.^23,24 During the second week of COVID-19 illness, IgM or IgG antibodies were detected in greater than 89% of infected patients.²³ Severe disease resulted in high concentrations of antibody.

When testing for IgM and IgG antibodies is widely available, it may become an option to test all health care workers. This will permit the assignment of those health care workers with the highest levels of antibody to frontline duties with COVID-19 patients during the next disease outbreak, likely to occur at some point during the next 12 months.

A COVID-19 vaccine

Dozens of research teams, including pharmaceutical and biotechnology companies and many academic laboratories, are working on developing and testing vaccines to prevent COVID-19 disease. An effective vaccine would reduce the number of people who develop severe disease during the next outbreak, reducing deaths, avoiding a shutdown of the country, and allowing the health systems to function normally. A vaccine is unlikely to be widely available until sometime early in 2021.

Facing COVID-19 well-being and mental health

SARS-CoV-2, like all viral particles, is incredibly small. Remarkably, it has changed permanently life on earth. COVID-19 is affecting our physical health, psychological well-being, economics, and patterns of social interaction. As clinicians it is difficult to face a viral enemy that cannot be stopped from causing the death of more than 100,000 people, including some of our clinical colleagues, within a short period of time.

Dr. Russ Harris, an Australian acceptance commitment therapist, has written an ebook (http://www.commpsych.com/wp-content/uploads/FACE_COVID-1.pdf) and produced an animated YouTube video, titled FACE COVID (https://www.youtube.com/watch?v=BmvNCdpHUYM), which describes a systematic approach to deal with the challenge of the pandemic. He advises a 9-step approach:

• F—focus on what is in your control
• A—acknowledge your thoughts and feelings
• C—come back to a focus on your body
• E—engage in what you are doing
• C—commit to acting effectively based on your core values
• O—opening up to difficult feelings and being kind to yourself and others
• V—values should guide your actions
• I—identify resources for help, assistance, support, and advice
• D—disinfect and practice social distancing.

This war will come to an end

During the American Revolution, colonists faced housing and food insecurity, epidemics of typhus and smallpox, traumatic injury including amputation of limbs, and a complete disruption of normal life activities. They persevered and, against the odds, successfully concluded the war. Unlike the colonists, who did not know if their conflict would end with success or failure, we clinicians know that the COVID-19 pandemic will end. We also know that eventually the global community of clinicians will develop and deploy the effective weapons we need to prevent a recurrence of this traumatic pandemic: population-wide testing for both the SARS-CoV-2 virus and serologic testing for IgG and IgM antibodies to the virus, effective antiviral medications, and a potent vaccine. ●

I am writing this in mid-April, in time for our May issue. These are unusual times. During unusual times, people rise up and do unusual and exemplary things. I firmly believe in the ability of humans to rise to the occasion and step out of their boundaries and boxes when needed. And the current COVID-19 pandemic is no exception. Our patients need us. The medical community needs us, and hematologists around the world have stepped up to help in any ways they can.

Since the beginning of the year with rumblings of the emergence of a novel SARs-CoV-2 virus in patients with influenza-like illness, the hematology community has banded together to figure out what this will mean for our patients battling malignant and nonmalignant blood disorders.

With very little published literature to go on, we have had to glean from our experience with the H1N1 influenza pandemic to develop a strategy to support hematology patients who may develop COVID-19 infection. With more questions than answers, institutions around the country and globally began to collaborate and communicate furiously with each other to learn from those who had experienced the effects of the virus before we had. We have been learning to anticipate blood supply changes, treatment modifications, and therapeutic needs for those who will inevitably get the virus.

Concern rose not just for the patients but also for the providers and clinical team who care for the hematology patients. How do we preserve and protect our workforce? A pandemic does not prevent new-diagnosis leukemia or myelodysplastic syndrome blast crisis from presenting as usual at 3 p.m. on a Friday afternoon. Who is at highest risk among the staff? If we practice social distancing what does that look like in a hematology clinic, in an infusion room? Or on the stem cell transplant in-patient unit? So many questions with minimal scientific evidence to guide our decisions.

As a sickle cell disease (SCD) specialist, I had some unique concerns. Roughly 10%-15% of the sickle cell population in the United States are supported by monthly red blood cell exchange transfusions, a lifesaving therapy to prevent recurrent stroke and to manage severe end organ damage. The vast majority of patients are on some disease-modifying therapy that requires ongoing lifelong monitoring of hematologic parameters, as well as renal and hepatic function. Most SCD patients also are members of racial minorities, live in densely populated parts of the city, and have significant social determinants of health that make adherence to social distancing mandates near impossible.

Frequent exposure to acute care for painful exacerbations of their disease, preexisting comorbidities involving the lung, heart, and kidney, and their underlying cellular and humoral immune dysfunction also put our patients at heightened risk of contracting COVID-19 infection.

So how have we handled the COVID-19 pandemic thus far? We have engaged various partners, collaborators, and colleagues to figure things out. Our institutions have established incident command operations to supervise and guide bed management, staff deployment/redeployment, and the supply chain, particularly as regards personal protective equipment; and to support physician and staff wellness. Our administrative leaders have partnered seamlessly with clinical leaders to rapidly roll out robust telemedicine strategies so that we can continue to provide ongoing medical care as best we can.

We have worked tirelessly across disciplines to develop guidance documents that are specialty specific with ways to support disease populations working with the hospitalist and acute care units to define testing, treatment, and admission and discharge criteria. We have engaged communications teams that have developed health-literate public messaging for the patients and the community about coronavirus as well as the rapidly changing public health guidelines to help #flattenthecurve.

As providers, we have reviewed our patient panels to determine who can tolerate appointment delays and who has to come in to be seen with minimal impact to health outcomes. We have read more articles in the past month than perhaps the past year; listened to more podcasts, webinars, and virtual lectures on COVID-19 and strategies to halt spread of the virus – just trying to learn more. We have engaged in social media – following COVID-19 public and private groups – to get and to offer support, as well as keep a finger on the pulse of the health community around this pandemic.

For my SCD population, I have had to decide who can tolerate simple rather than exchange transfusions for the next 3-6 months and what is the minimum number of red cell units we can safely use per red cell exchange procedure as we prepare for a possible blood supply shortage. The hematology community has worked tirelessly with national societies and numerous stakeholder groups to develop a comprehensive toolkit with regularly updated information about COVID-19 relevant to the hematology community (hematology.org/covid-19).

At a practice level, we are proactively reaching out to our hematology patients and their families to reassure them and connect them with resources and support while ensuring that they have adequate supply of their daily hematology medications with tips like using the pharmacy drive-through or home medication delivery options. The past 2 weeks in Charlotte, N.C., have been hectic with preparation. My days are long; a mixture of telemedicine visits, strategic meetings, and meetings to cascade the newest plan to the staff so that they know and are comfortable with it for the patients they take care of.

When the adrenaline from each day begins to wane, we think of our individual families; we worry about relatives far and near. We mourn the loss of loved ones or other hematologists or providers who have succumbed to the COVID-19 virus. We take a minute to think about ourselves and how this pandemic affects us individually and personally. I think about my older sister who runs a smaller hospital in the Bronx, N.Y. She is at the epicenter of the pandemic and is short-staffed in the ICU and medicine floors. Because she is an ob.gyn, she has called me for guidance on a pregnant woman with anemia and sickle cell trait. I hadn’t heard from her in 24 hours and I began to wonder – is she okay? Why didn’t she answer my call this morning? Is she sick? Did she get the information I sent to her linking her with our virtual ICU experts so she can implement a similar program for her hospital?

Next, I think of my younger sister in Long Island, N.Y., who was covering shifts as a hospitalist. She had asked me to send her some hematology tips on managing disseminated intravascular coagulopathy in COVID-19 patients as she has limited access to consultants. She sees an average of seven to nine COVID-19–positive patients and several persons under investigation per shift.

I also think of my 76-year-old mom who is upset that she cannot go to the adult center because of social distancing. So, even though I am weary, I do a FaceTime call with mom. I try to explain why it’s important for her to stay indoors. It’s only temporary, I reassure her; but I cannot say how long “temporary” is.

I pack up my bags, change out of my scrubs to head to my car thinking of my daughter who just turned 21 years old and was so excited about her college graduation in May. She had a meltdown yesterday because her university announced there will be no in-person gradation. I wonder how I can help her see the big picture and yet, why should she? She’s only 21.

Then I get a page – it’s a patient with sickle cell disease – my first COVID-19–positive patient. As I take the history and turn my computer back on to do this consult, I realize that this is what all the preparation was for. The sickle cell guidance document we had worked on over the past weeks to outline a step-by-step approach to managing a SCD patient with COVID-19 that is intentionally aligned with our institutions COVID-19 treatment protocol with specific nuances relevant to patients with red blood cell disorders, was now being put to use. I felt glad for my patient that we were prepared and had a semblance of a plan on how to approach his care.

The battle is far from over. Actually, as of my writing this, it’s just starting in my part of the country. The days will continue to be long. I continue to appreciate the beauty of the human spirit among the people we work with, the hematology community we belong to, and the patients that we serve. I am committed (as are all of you) to staying “on-duty” for as long as I can, and I’d like to take this opportunity to say to all the hematologists out there – “Thank you for your service and for reporting for duty to the front lines.”

Ifeyinwa (Ify) Osunkwo, MD, MPH, is a professor of medicine and the director of the Sickle Cell Disease Enterprise at the Levine Cancer Institute, Atrium Health, Charlotte, N.C. She is the editor in chief of Hematology News.

I am writing this in mid-April, in time for our May issue. These are unusual times. During unusual times, people rise up and do unusual and exemplary things. I firmly believe in the ability of humans to rise to the occasion and step out of their boundaries and boxes when needed. And the current COVID-19 pandemic is no exception. Our patients need us. The medical community needs us, and hematologists around the world have stepped up to help in any ways they can.

Since the beginning of the year with rumblings of the emergence of a novel SARs-CoV-2 virus in patients with influenza-like illness, the hematology community has banded together to figure out what this will mean for our patients battling malignant and nonmalignant blood disorders.

With very little published literature to go on, we have had to glean from our experience with the H1N1 influenza pandemic to develop a strategy to support hematology patients who may develop COVID-19 infection. With more questions than answers, institutions around the country and globally began to collaborate and communicate furiously with each other to learn from those who had experienced the effects of the virus before we had. We have been learning to anticipate blood supply changes, treatment modifications, and therapeutic needs for those who will inevitably get the virus.

Concern rose not just for the patients but also for the providers and clinical team who care for the hematology patients. How do we preserve and protect our workforce? A pandemic does not prevent new-diagnosis leukemia or myelodysplastic syndrome blast crisis from presenting as usual at 3 p.m. on a Friday afternoon. Who is at highest risk among the staff? If we practice social distancing what does that look like in a hematology clinic, in an infusion room? Or on the stem cell transplant in-patient unit? So many questions with minimal scientific evidence to guide our decisions.

As a sickle cell disease (SCD) specialist, I had some unique concerns. Roughly 10%-15% of the sickle cell population in the United States are supported by monthly red blood cell exchange transfusions, a lifesaving therapy to prevent recurrent stroke and to manage severe end organ damage. The vast majority of patients are on some disease-modifying therapy that requires ongoing lifelong monitoring of hematologic parameters, as well as renal and hepatic function. Most SCD patients also are members of racial minorities, live in densely populated parts of the city, and have significant social determinants of health that make adherence to social distancing mandates near impossible.

Frequent exposure to acute care for painful exacerbations of their disease, preexisting comorbidities involving the lung, heart, and kidney, and their underlying cellular and humoral immune dysfunction also put our patients at heightened risk of contracting COVID-19 infection.

So how have we handled the COVID-19 pandemic thus far? We have engaged various partners, collaborators, and colleagues to figure things out. Our institutions have established incident command operations to supervise and guide bed management, staff deployment/redeployment, and the supply chain, particularly as regards personal protective equipment; and to support physician and staff wellness. Our administrative leaders have partnered seamlessly with clinical leaders to rapidly roll out robust telemedicine strategies so that we can continue to provide ongoing medical care as best we can.

We have worked tirelessly across disciplines to develop guidance documents that are specialty specific with ways to support disease populations working with the hospitalist and acute care units to define testing, treatment, and admission and discharge criteria. We have engaged communications teams that have developed health-literate public messaging for the patients and the community about coronavirus as well as the rapidly changing public health guidelines to help #flattenthecurve.

As providers, we have reviewed our patient panels to determine who can tolerate appointment delays and who has to come in to be seen with minimal impact to health outcomes. We have read more articles in the past month than perhaps the past year; listened to more podcasts, webinars, and virtual lectures on COVID-19 and strategies to halt spread of the virus – just trying to learn more. We have engaged in social media – following COVID-19 public and private groups – to get and to offer support, as well as keep a finger on the pulse of the health community around this pandemic.

For my SCD population, I have had to decide who can tolerate simple rather than exchange transfusions for the next 3-6 months and what is the minimum number of red cell units we can safely use per red cell exchange procedure as we prepare for a possible blood supply shortage. The hematology community has worked tirelessly with national societies and numerous stakeholder groups to develop a comprehensive toolkit with regularly updated information about COVID-19 relevant to the hematology community (hematology.org/covid-19).

At a practice level, we are proactively reaching out to our hematology patients and their families to reassure them and connect them with resources and support while ensuring that they have adequate supply of their daily hematology medications with tips like using the pharmacy drive-through or home medication delivery options. The past 2 weeks in Charlotte, N.C., have been hectic with preparation. My days are long; a mixture of telemedicine visits, strategic meetings, and meetings to cascade the newest plan to the staff so that they know and are comfortable with it for the patients they take care of.

When the adrenaline from each day begins to wane, we think of our individual families; we worry about relatives far and near. We mourn the loss of loved ones or other hematologists or providers who have succumbed to the COVID-19 virus. We take a minute to think about ourselves and how this pandemic affects us individually and personally. I think about my older sister who runs a smaller hospital in the Bronx, N.Y. She is at the epicenter of the pandemic and is short-staffed in the ICU and medicine floors. Because she is an ob.gyn, she has called me for guidance on a pregnant woman with anemia and sickle cell trait. I hadn’t heard from her in 24 hours and I began to wonder – is she okay? Why didn’t she answer my call this morning? Is she sick? Did she get the information I sent to her linking her with our virtual ICU experts so she can implement a similar program for her hospital?

Next, I think of my younger sister in Long Island, N.Y., who was covering shifts as a hospitalist. She had asked me to send her some hematology tips on managing disseminated intravascular coagulopathy in COVID-19 patients as she has limited access to consultants. She sees an average of seven to nine COVID-19–positive patients and several persons under investigation per shift.

I also think of my 76-year-old mom who is upset that she cannot go to the adult center because of social distancing. So, even though I am weary, I do a FaceTime call with mom. I try to explain why it’s important for her to stay indoors. It’s only temporary, I reassure her; but I cannot say how long “temporary” is.

I pack up my bags, change out of my scrubs to head to my car thinking of my daughter who just turned 21 years old and was so excited about her college graduation in May. She had a meltdown yesterday because her university announced there will be no in-person gradation. I wonder how I can help her see the big picture and yet, why should she? She’s only 21.

Then I get a page – it’s a patient with sickle cell disease – my first COVID-19–positive patient. As I take the history and turn my computer back on to do this consult, I realize that this is what all the preparation was for. The sickle cell guidance document we had worked on over the past weeks to outline a step-by-step approach to managing a SCD patient with COVID-19 that is intentionally aligned with our institutions COVID-19 treatment protocol with specific nuances relevant to patients with red blood cell disorders, was now being put to use. I felt glad for my patient that we were prepared and had a semblance of a plan on how to approach his care.

The battle is far from over. Actually, as of my writing this, it’s just starting in my part of the country. The days will continue to be long. I continue to appreciate the beauty of the human spirit among the people we work with, the hematology community we belong to, and the patients that we serve. I am committed (as are all of you) to staying “on-duty” for as long as I can, and I’d like to take this opportunity to say to all the hematologists out there – “Thank you for your service and for reporting for duty to the front lines.”

Ifeyinwa (Ify) Osunkwo, MD, MPH, is a professor of medicine and the director of the Sickle Cell Disease Enterprise at the Levine Cancer Institute, Atrium Health, Charlotte, N.C. She is the editor in chief of Hematology News.

I am writing this in mid-April, in time for our May issue. These are unusual times. During unusual times, people rise up and do unusual and exemplary things. I firmly believe in the ability of humans to rise to the occasion and step out of their boundaries and boxes when needed. And the current COVID-19 pandemic is no exception. Our patients need us. The medical community needs us, and hematologists around the world have stepped up to help in any ways they can.

Since the beginning of the year with rumblings of the emergence of a novel SARs-CoV-2 virus in patients with influenza-like illness, the hematology community has banded together to figure out what this will mean for our patients battling malignant and nonmalignant blood disorders.

With very little published literature to go on, we have had to glean from our experience with the H1N1 influenza pandemic to develop a strategy to support hematology patients who may develop COVID-19 infection. With more questions than answers, institutions around the country and globally began to collaborate and communicate furiously with each other to learn from those who had experienced the effects of the virus before we had. We have been learning to anticipate blood supply changes, treatment modifications, and therapeutic needs for those who will inevitably get the virus.

Concern rose not just for the patients but also for the providers and clinical team who care for the hematology patients. How do we preserve and protect our workforce? A pandemic does not prevent new-diagnosis leukemia or myelodysplastic syndrome blast crisis from presenting as usual at 3 p.m. on a Friday afternoon. Who is at highest risk among the staff? If we practice social distancing what does that look like in a hematology clinic, in an infusion room? Or on the stem cell transplant in-patient unit? So many questions with minimal scientific evidence to guide our decisions.

As a sickle cell disease (SCD) specialist, I had some unique concerns. Roughly 10%-15% of the sickle cell population in the United States are supported by monthly red blood cell exchange transfusions, a lifesaving therapy to prevent recurrent stroke and to manage severe end organ damage. The vast majority of patients are on some disease-modifying therapy that requires ongoing lifelong monitoring of hematologic parameters, as well as renal and hepatic function. Most SCD patients also are members of racial minorities, live in densely populated parts of the city, and have significant social determinants of health that make adherence to social distancing mandates near impossible.

Frequent exposure to acute care for painful exacerbations of their disease, preexisting comorbidities involving the lung, heart, and kidney, and their underlying cellular and humoral immune dysfunction also put our patients at heightened risk of contracting COVID-19 infection.

So how have we handled the COVID-19 pandemic thus far? We have engaged various partners, collaborators, and colleagues to figure things out. Our institutions have established incident command operations to supervise and guide bed management, staff deployment/redeployment, and the supply chain, particularly as regards personal protective equipment; and to support physician and staff wellness. Our administrative leaders have partnered seamlessly with clinical leaders to rapidly roll out robust telemedicine strategies so that we can continue to provide ongoing medical care as best we can.

We have worked tirelessly across disciplines to develop guidance documents that are specialty specific with ways to support disease populations working with the hospitalist and acute care units to define testing, treatment, and admission and discharge criteria. We have engaged communications teams that have developed health-literate public messaging for the patients and the community about coronavirus as well as the rapidly changing public health guidelines to help #flattenthecurve.

As providers, we have reviewed our patient panels to determine who can tolerate appointment delays and who has to come in to be seen with minimal impact to health outcomes. We have read more articles in the past month than perhaps the past year; listened to more podcasts, webinars, and virtual lectures on COVID-19 and strategies to halt spread of the virus – just trying to learn more. We have engaged in social media – following COVID-19 public and private groups – to get and to offer support, as well as keep a finger on the pulse of the health community around this pandemic.

For my SCD population, I have had to decide who can tolerate simple rather than exchange transfusions for the next 3-6 months and what is the minimum number of red cell units we can safely use per red cell exchange procedure as we prepare for a possible blood supply shortage. The hematology community has worked tirelessly with national societies and numerous stakeholder groups to develop a comprehensive toolkit with regularly updated information about COVID-19 relevant to the hematology community (hematology.org/covid-19).

At a practice level, we are proactively reaching out to our hematology patients and their families to reassure them and connect them with resources and support while ensuring that they have adequate supply of their daily hematology medications with tips like using the pharmacy drive-through or home medication delivery options. The past 2 weeks in Charlotte, N.C., have been hectic with preparation. My days are long; a mixture of telemedicine visits, strategic meetings, and meetings to cascade the newest plan to the staff so that they know and are comfortable with it for the patients they take care of.

When the adrenaline from each day begins to wane, we think of our individual families; we worry about relatives far and near. We mourn the loss of loved ones or other hematologists or providers who have succumbed to the COVID-19 virus. We take a minute to think about ourselves and how this pandemic affects us individually and personally. I think about my older sister who runs a smaller hospital in the Bronx, N.Y. She is at the epicenter of the pandemic and is short-staffed in the ICU and medicine floors. Because she is an ob.gyn, she has called me for guidance on a pregnant woman with anemia and sickle cell trait. I hadn’t heard from her in 24 hours and I began to wonder – is she okay? Why didn’t she answer my call this morning? Is she sick? Did she get the information I sent to her linking her with our virtual ICU experts so she can implement a similar program for her hospital?

Next, I think of my younger sister in Long Island, N.Y., who was covering shifts as a hospitalist. She had asked me to send her some hematology tips on managing disseminated intravascular coagulopathy in COVID-19 patients as she has limited access to consultants. She sees an average of seven to nine COVID-19–positive patients and several persons under investigation per shift.

I also think of my 76-year-old mom who is upset that she cannot go to the adult center because of social distancing. So, even though I am weary, I do a FaceTime call with mom. I try to explain why it’s important for her to stay indoors. It’s only temporary, I reassure her; but I cannot say how long “temporary” is.

I pack up my bags, change out of my scrubs to head to my car thinking of my daughter who just turned 21 years old and was so excited about her college graduation in May. She had a meltdown yesterday because her university announced there will be no in-person gradation. I wonder how I can help her see the big picture and yet, why should she? She’s only 21.

Then I get a page – it’s a patient with sickle cell disease – my first COVID-19–positive patient. As I take the history and turn my computer back on to do this consult, I realize that this is what all the preparation was for. The sickle cell guidance document we had worked on over the past weeks to outline a step-by-step approach to managing a SCD patient with COVID-19 that is intentionally aligned with our institutions COVID-19 treatment protocol with specific nuances relevant to patients with red blood cell disorders, was now being put to use. I felt glad for my patient that we were prepared and had a semblance of a plan on how to approach his care.

The battle is far from over. Actually, as of my writing this, it’s just starting in my part of the country. The days will continue to be long. I continue to appreciate the beauty of the human spirit among the people we work with, the hematology community we belong to, and the patients that we serve. I am committed (as are all of you) to staying “on-duty” for as long as I can, and I’d like to take this opportunity to say to all the hematologists out there – “Thank you for your service and for reporting for duty to the front lines.”

Ifeyinwa (Ify) Osunkwo, MD, MPH, is a professor of medicine and the director of the Sickle Cell Disease Enterprise at the Levine Cancer Institute, Atrium Health, Charlotte, N.C. She is the editor in chief of Hematology News.