The Veterans Health Administration (VHA) clinical practice recommendations endorse a power mobility device (PMD) for individuals with adequate judgment, cognitive ability, and vision who are unable to propel a manual wheelchair or walk community distances despite standard medical and rehabilitative interventions.¹ VHA supports the use of a PMD in order to access medical care and accomplish activities of daily living, both at home and in the community for veterans with mobility limitations secondary to cardiovascular disease, neurologic disorders, pulmonary disease, or musculoskeletal disorders. The goal of a PMD use is increased participation in community and social life, improved health maintenance via enhanced access to medical facilities, and an overall enhanced quality of life. However, there is a common concern among health care providers that prescribing a PMD may decrease physical activity, in turn, leading to obesity and increasing morbidity. ²

The prevalence of obesity is increasing in the United States. In the past decade 35.0% of men and 36.8% of women were classified as obese (body mass index [BMI], ≥ 30).³ Recent figures from the Centers for Disease Control and Prevention estimate that the overall prevalence of obesity in Americans is closer to 42.4%.⁴ The veteran population is not immune to this; a 2014 study of nearly 5 million veterans reported that the prevalence of obesity in this population was 41%.^5,6 In addition to obesity being implicated in exacerbating many medical problems, such as osteoarthritis, insulin resistance, and heart disease, obesity also is associated with a significant decrease in lifespan.⁷ Almost half of adults who report ambulatory dysfunction are obese.⁸ Given the increased morbidity and mortality as a result of obesity, interventions that may promote weight gain need to be appropriately identified and minimized.

Methods

The institutional review board at Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia, reviewed and approved this study. A waiver of participant consent was approved due to the nature of the research (medical records of patients, some of whom were deceased) and the type of data collected (retrospective data). In addition, each individual was assigned a sequential code to de-identify any personal information. Prosthetics department medical records of consecutive veterans who received PMDs for the first time between January 1, 2011 and June 30, 2012, were reviewed.

Data extracted from the electronic health record (EHR) included demographics, indication for power mobility, weight at time of PMD prescription, weight at 2-years postprescription, and height. Weight readings were considered valid if weight was taken within 3 months of initial prescription and then again within 3 months at the 2-year interval. Individuals without weights recorded in these time frames were excluded. In addition, we excluded medical conditions that might significantly affect body weight, including amyotrophic lateral sclerosis (ALS), amputation during the study period, or history of weight loss surgery. Cancer diagnoses were excluded as they were not an indication for power mobility in the VHA. ALS, though variable in its disease course, was specifically excluded given the likelihood of these patients dying of the natural progression of the disease before the 2-year follow-up period: Median survival times in patients diagnosed with ALS aged > 60 years was < 15 months. ^10-12

The EHRs of 399 individuals who received a PMD during the period were reviewed, and 185 veterans met criteria for data analysis. Subject exclusions in the weight and BMI analysis included death during the follow-up period (89), missing data (68), prior PMD users who came in for replacements (53), and ALS (4) (Figure 1). Patients were not excluded based on the presence or absence of intentional weight loss efforts as this information was not readily available through chart review.

Statistical Analysis

The primary outcome measure was the change in BMI and body weight from time 1 (date of PMD prescription) to time 2 (2 years later). Analyses were performed using IBM SPSS Statistics, Version 21. BMI was calculated using the weight (lb) x 703/ (height [inches]).² Dichotomization of BMI was performed using the conventional cut scores: < 30.0, not obese; and ≥ 30.0, obese. Paired t tests and SPSS general linear model (repeated measures) were used to examine change of BMI from time 1 to time 2. The exact McNemar test was used to examine change in obesity classification across time 1 and time 2. Correlating with Yang’s retrospective observational study, data were analyzed separately for aged < 65 years and aged≥ 65 years.²

Results

Of the 185 veterans, 181 were male (98%); mean age was 67.3 years (range, 26-90); and 55% were aged ≥ 65 years. Musculoskeletal disorders (41.6%) were the most common primary indication for a PMD, followed by pulmonary disorders (25.4%) and cardiovascular disorders (23.8%) (Table 1).

There was a significant decrease in BMI in the first 2 years after receiving a PMD prescription for the first time (estimated marginal means: 31.5 to 30.9 , P = .02). However, age moderated the relationship between BMI and time F[1, 183] = 12.14, P = .001, partial η² = .06 (Table 2). The 101 subjects aged > 65 years experienced a significant decrease in BMI (estimated marginal means: 30.3 to 29.1, P < .001), whereas the 84 patients aged < 65 years experienced a slight and nonsignificant increase in BMI (estimated marginal means: 32.9 to 33.1, P = .45). BMI was significantly higher for subjects aged < 65 years at Time 1 (F[1, 183] = 4.32, P = .04, partial η² = .02) and at Time 2 (F[1, 183] = 11.04, P = .001, partial η² = .06).

Discussion

This study demonstrated a significant decrease in both weight and BMI at 2 years after the initiation of a PMD in patients aged < 65 years. No significant change was found for obesity rates. However, veterans who met criteria for obesity at the time of PMD prescription saw a significant decrease in their weight at 2 years compared with those who were nonobese.

VHA supports power mobility when there is a clear functional need that cannot be met by rehabilitation, surgical, or medical interventions to enhance veterans’ abilities to access medical care, accomplish necessary tasks of daily living, and to have greater access to their communities. Though limited by strength of association, studies involving PMD users generally found improvement in reported functional outcomes and overall satisfaction with PMD use based on a systematic review.¹³ Nonetheless, there is an implicit concern among providers that a PMD prescription, by limiting physical activity, may exacerbate obesity trends in potentially high-risk individuals.

However, a controversy exists about whether increasing physical activity alone leads to weight loss. A 2007 study followed 102 sedentary men and 100 women over 1 year randomized to moderately intensive exercise for 60 minutes, 6 days a week vs no intervention.¹⁴ The men lost an average of 4 pounds, and women lost an average of 3 pounds after 1 year. The Women’s Health Study divided 39,876 women into high, medium, and low levels of exercise groups. After 10 years, the intense exercise group did not have any significant weight loss.¹⁵

Our study was consistent with existing literature in that a PMD prescription did not correlate with weight gain.^2,9 In our veteran population aged ≥ 65 years, we observed an opposite trend of weight loss after PMD prescription. Of note, studies have shown that peak body weight occurs in the sixth decade, remains stable until about aged 70 years, and then slowly decreases thereafter, at a rate of 0.1 to 0.2 kg per year.¹⁶ This likely explains some of the weight loss trend we observed in our study of veterans aged ≥ 65 years. Possible additional explanations include improved access to health care and to more nutritional foods that promote general health and well-being.

Limitations

The data were gathered from a predominantly male veteran population, potentially limiting generalizability. The health of any individual is determined by the interaction of factors of which body weight is just a single, isolated component. As such, the effect of powered mobility on body weight is not a direct reflection on the effect on overall health. Additionally, there are many factors that may affect an individual’s body weight, such as optimal management of medical comorbidities, which could not be controlled for in this study. Also, while these values can be compared with other veteran populations, this study had no true control group.

Conclusions

Based on the findings of this study with aforementioned limitations, PMD use does not seem to be associated with significant weight changes. Further studies using control groups and assessing comorbidities are needed.

The Veterans Health Administration (VHA) clinical practice recommendations endorse a power mobility device (PMD) for individuals with adequate judgment, cognitive ability, and vision who are unable to propel a manual wheelchair or walk community distances despite standard medical and rehabilitative interventions.¹ VHA supports the use of a PMD in order to access medical care and accomplish activities of daily living, both at home and in the community for veterans with mobility limitations secondary to cardiovascular disease, neurologic disorders, pulmonary disease, or musculoskeletal disorders. The goal of a PMD use is increased participation in community and social life, improved health maintenance via enhanced access to medical facilities, and an overall enhanced quality of life. However, there is a common concern among health care providers that prescribing a PMD may decrease physical activity, in turn, leading to obesity and increasing morbidity. ²

The prevalence of obesity is increasing in the United States. In the past decade 35.0% of men and 36.8% of women were classified as obese (body mass index [BMI], ≥ 30).³ Recent figures from the Centers for Disease Control and Prevention estimate that the overall prevalence of obesity in Americans is closer to 42.4%.⁴ The veteran population is not immune to this; a 2014 study of nearly 5 million veterans reported that the prevalence of obesity in this population was 41%.^5,6 In addition to obesity being implicated in exacerbating many medical problems, such as osteoarthritis, insulin resistance, and heart disease, obesity also is associated with a significant decrease in lifespan.⁷ Almost half of adults who report ambulatory dysfunction are obese.⁸ Given the increased morbidity and mortality as a result of obesity, interventions that may promote weight gain need to be appropriately identified and minimized.

Methods

The institutional review board at Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia, reviewed and approved this study. A waiver of participant consent was approved due to the nature of the research (medical records of patients, some of whom were deceased) and the type of data collected (retrospective data). In addition, each individual was assigned a sequential code to de-identify any personal information. Prosthetics department medical records of consecutive veterans who received PMDs for the first time between January 1, 2011 and June 30, 2012, were reviewed.

Data extracted from the electronic health record (EHR) included demographics, indication for power mobility, weight at time of PMD prescription, weight at 2-years postprescription, and height. Weight readings were considered valid if weight was taken within 3 months of initial prescription and then again within 3 months at the 2-year interval. Individuals without weights recorded in these time frames were excluded. In addition, we excluded medical conditions that might significantly affect body weight, including amyotrophic lateral sclerosis (ALS), amputation during the study period, or history of weight loss surgery. Cancer diagnoses were excluded as they were not an indication for power mobility in the VHA. ALS, though variable in its disease course, was specifically excluded given the likelihood of these patients dying of the natural progression of the disease before the 2-year follow-up period: Median survival times in patients diagnosed with ALS aged > 60 years was < 15 months. ^10-12

The EHRs of 399 individuals who received a PMD during the period were reviewed, and 185 veterans met criteria for data analysis. Subject exclusions in the weight and BMI analysis included death during the follow-up period (89), missing data (68), prior PMD users who came in for replacements (53), and ALS (4) (Figure 1). Patients were not excluded based on the presence or absence of intentional weight loss efforts as this information was not readily available through chart review.

Statistical Analysis

The primary outcome measure was the change in BMI and body weight from time 1 (date of PMD prescription) to time 2 (2 years later). Analyses were performed using IBM SPSS Statistics, Version 21. BMI was calculated using the weight (lb) x 703/ (height [inches]).² Dichotomization of BMI was performed using the conventional cut scores: < 30.0, not obese; and ≥ 30.0, obese. Paired t tests and SPSS general linear model (repeated measures) were used to examine change of BMI from time 1 to time 2. The exact McNemar test was used to examine change in obesity classification across time 1 and time 2. Correlating with Yang’s retrospective observational study, data were analyzed separately for aged < 65 years and aged≥ 65 years.²

Results

Of the 185 veterans, 181 were male (98%); mean age was 67.3 years (range, 26-90); and 55% were aged ≥ 65 years. Musculoskeletal disorders (41.6%) were the most common primary indication for a PMD, followed by pulmonary disorders (25.4%) and cardiovascular disorders (23.8%) (Table 1).

There was a significant decrease in BMI in the first 2 years after receiving a PMD prescription for the first time (estimated marginal means: 31.5 to 30.9 , P = .02). However, age moderated the relationship between BMI and time F[1, 183] = 12.14, P = .001, partial η² = .06 (Table 2). The 101 subjects aged > 65 years experienced a significant decrease in BMI (estimated marginal means: 30.3 to 29.1, P < .001), whereas the 84 patients aged < 65 years experienced a slight and nonsignificant increase in BMI (estimated marginal means: 32.9 to 33.1, P = .45). BMI was significantly higher for subjects aged < 65 years at Time 1 (F[1, 183] = 4.32, P = .04, partial η² = .02) and at Time 2 (F[1, 183] = 11.04, P = .001, partial η² = .06).

Discussion

This study demonstrated a significant decrease in both weight and BMI at 2 years after the initiation of a PMD in patients aged < 65 years. No significant change was found for obesity rates. However, veterans who met criteria for obesity at the time of PMD prescription saw a significant decrease in their weight at 2 years compared with those who were nonobese.

VHA supports power mobility when there is a clear functional need that cannot be met by rehabilitation, surgical, or medical interventions to enhance veterans’ abilities to access medical care, accomplish necessary tasks of daily living, and to have greater access to their communities. Though limited by strength of association, studies involving PMD users generally found improvement in reported functional outcomes and overall satisfaction with PMD use based on a systematic review.¹³ Nonetheless, there is an implicit concern among providers that a PMD prescription, by limiting physical activity, may exacerbate obesity trends in potentially high-risk individuals.

However, a controversy exists about whether increasing physical activity alone leads to weight loss. A 2007 study followed 102 sedentary men and 100 women over 1 year randomized to moderately intensive exercise for 60 minutes, 6 days a week vs no intervention.¹⁴ The men lost an average of 4 pounds, and women lost an average of 3 pounds after 1 year. The Women’s Health Study divided 39,876 women into high, medium, and low levels of exercise groups. After 10 years, the intense exercise group did not have any significant weight loss.¹⁵

Our study was consistent with existing literature in that a PMD prescription did not correlate with weight gain.^2,9 In our veteran population aged ≥ 65 years, we observed an opposite trend of weight loss after PMD prescription. Of note, studies have shown that peak body weight occurs in the sixth decade, remains stable until about aged 70 years, and then slowly decreases thereafter, at a rate of 0.1 to 0.2 kg per year.¹⁶ This likely explains some of the weight loss trend we observed in our study of veterans aged ≥ 65 years. Possible additional explanations include improved access to health care and to more nutritional foods that promote general health and well-being.

Limitations

The data were gathered from a predominantly male veteran population, potentially limiting generalizability. The health of any individual is determined by the interaction of factors of which body weight is just a single, isolated component. As such, the effect of powered mobility on body weight is not a direct reflection on the effect on overall health. Additionally, there are many factors that may affect an individual’s body weight, such as optimal management of medical comorbidities, which could not be controlled for in this study. Also, while these values can be compared with other veteran populations, this study had no true control group.

Conclusions

Based on the findings of this study with aforementioned limitations, PMD use does not seem to be associated with significant weight changes. Further studies using control groups and assessing comorbidities are needed.

The Veterans Health Administration (VHA) clinical practice recommendations endorse a power mobility device (PMD) for individuals with adequate judgment, cognitive ability, and vision who are unable to propel a manual wheelchair or walk community distances despite standard medical and rehabilitative interventions.¹ VHA supports the use of a PMD in order to access medical care and accomplish activities of daily living, both at home and in the community for veterans with mobility limitations secondary to cardiovascular disease, neurologic disorders, pulmonary disease, or musculoskeletal disorders. The goal of a PMD use is increased participation in community and social life, improved health maintenance via enhanced access to medical facilities, and an overall enhanced quality of life. However, there is a common concern among health care providers that prescribing a PMD may decrease physical activity, in turn, leading to obesity and increasing morbidity. ²

The prevalence of obesity is increasing in the United States. In the past decade 35.0% of men and 36.8% of women were classified as obese (body mass index [BMI], ≥ 30).³ Recent figures from the Centers for Disease Control and Prevention estimate that the overall prevalence of obesity in Americans is closer to 42.4%.⁴ The veteran population is not immune to this; a 2014 study of nearly 5 million veterans reported that the prevalence of obesity in this population was 41%.^5,6 In addition to obesity being implicated in exacerbating many medical problems, such as osteoarthritis, insulin resistance, and heart disease, obesity also is associated with a significant decrease in lifespan.⁷ Almost half of adults who report ambulatory dysfunction are obese.⁸ Given the increased morbidity and mortality as a result of obesity, interventions that may promote weight gain need to be appropriately identified and minimized.

Methods

The institutional review board at Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia, reviewed and approved this study. A waiver of participant consent was approved due to the nature of the research (medical records of patients, some of whom were deceased) and the type of data collected (retrospective data). In addition, each individual was assigned a sequential code to de-identify any personal information. Prosthetics department medical records of consecutive veterans who received PMDs for the first time between January 1, 2011 and June 30, 2012, were reviewed.

Data extracted from the electronic health record (EHR) included demographics, indication for power mobility, weight at time of PMD prescription, weight at 2-years postprescription, and height. Weight readings were considered valid if weight was taken within 3 months of initial prescription and then again within 3 months at the 2-year interval. Individuals without weights recorded in these time frames were excluded. In addition, we excluded medical conditions that might significantly affect body weight, including amyotrophic lateral sclerosis (ALS), amputation during the study period, or history of weight loss surgery. Cancer diagnoses were excluded as they were not an indication for power mobility in the VHA. ALS, though variable in its disease course, was specifically excluded given the likelihood of these patients dying of the natural progression of the disease before the 2-year follow-up period: Median survival times in patients diagnosed with ALS aged > 60 years was < 15 months. ^10-12

The EHRs of 399 individuals who received a PMD during the period were reviewed, and 185 veterans met criteria for data analysis. Subject exclusions in the weight and BMI analysis included death during the follow-up period (89), missing data (68), prior PMD users who came in for replacements (53), and ALS (4) (Figure 1). Patients were not excluded based on the presence or absence of intentional weight loss efforts as this information was not readily available through chart review.

Statistical Analysis

The primary outcome measure was the change in BMI and body weight from time 1 (date of PMD prescription) to time 2 (2 years later). Analyses were performed using IBM SPSS Statistics, Version 21. BMI was calculated using the weight (lb) x 703/ (height [inches]).² Dichotomization of BMI was performed using the conventional cut scores: < 30.0, not obese; and ≥ 30.0, obese. Paired t tests and SPSS general linear model (repeated measures) were used to examine change of BMI from time 1 to time 2. The exact McNemar test was used to examine change in obesity classification across time 1 and time 2. Correlating with Yang’s retrospective observational study, data were analyzed separately for aged < 65 years and aged≥ 65 years.²

Results

Of the 185 veterans, 181 were male (98%); mean age was 67.3 years (range, 26-90); and 55% were aged ≥ 65 years. Musculoskeletal disorders (41.6%) were the most common primary indication for a PMD, followed by pulmonary disorders (25.4%) and cardiovascular disorders (23.8%) (Table 1).

There was a significant decrease in BMI in the first 2 years after receiving a PMD prescription for the first time (estimated marginal means: 31.5 to 30.9 , P = .02). However, age moderated the relationship between BMI and time F[1, 183] = 12.14, P = .001, partial η² = .06 (Table 2). The 101 subjects aged > 65 years experienced a significant decrease in BMI (estimated marginal means: 30.3 to 29.1, P < .001), whereas the 84 patients aged < 65 years experienced a slight and nonsignificant increase in BMI (estimated marginal means: 32.9 to 33.1, P = .45). BMI was significantly higher for subjects aged < 65 years at Time 1 (F[1, 183] = 4.32, P = .04, partial η² = .02) and at Time 2 (F[1, 183] = 11.04, P = .001, partial η² = .06).

Discussion

This study demonstrated a significant decrease in both weight and BMI at 2 years after the initiation of a PMD in patients aged < 65 years. No significant change was found for obesity rates. However, veterans who met criteria for obesity at the time of PMD prescription saw a significant decrease in their weight at 2 years compared with those who were nonobese.

VHA supports power mobility when there is a clear functional need that cannot be met by rehabilitation, surgical, or medical interventions to enhance veterans’ abilities to access medical care, accomplish necessary tasks of daily living, and to have greater access to their communities. Though limited by strength of association, studies involving PMD users generally found improvement in reported functional outcomes and overall satisfaction with PMD use based on a systematic review.¹³ Nonetheless, there is an implicit concern among providers that a PMD prescription, by limiting physical activity, may exacerbate obesity trends in potentially high-risk individuals.

However, a controversy exists about whether increasing physical activity alone leads to weight loss. A 2007 study followed 102 sedentary men and 100 women over 1 year randomized to moderately intensive exercise for 60 minutes, 6 days a week vs no intervention.¹⁴ The men lost an average of 4 pounds, and women lost an average of 3 pounds after 1 year. The Women’s Health Study divided 39,876 women into high, medium, and low levels of exercise groups. After 10 years, the intense exercise group did not have any significant weight loss.¹⁵

Our study was consistent with existing literature in that a PMD prescription did not correlate with weight gain.^2,9 In our veteran population aged ≥ 65 years, we observed an opposite trend of weight loss after PMD prescription. Of note, studies have shown that peak body weight occurs in the sixth decade, remains stable until about aged 70 years, and then slowly decreases thereafter, at a rate of 0.1 to 0.2 kg per year.¹⁶ This likely explains some of the weight loss trend we observed in our study of veterans aged ≥ 65 years. Possible additional explanations include improved access to health care and to more nutritional foods that promote general health and well-being.

Limitations

The data were gathered from a predominantly male veteran population, potentially limiting generalizability. The health of any individual is determined by the interaction of factors of which body weight is just a single, isolated component. As such, the effect of powered mobility on body weight is not a direct reflection on the effect on overall health. Additionally, there are many factors that may affect an individual’s body weight, such as optimal management of medical comorbidities, which could not be controlled for in this study. Also, while these values can be compared with other veteran populations, this study had no true control group.

Conclusions

Based on the findings of this study with aforementioned limitations, PMD use does not seem to be associated with significant weight changes. Further studies using control groups and assessing comorbidities are needed.

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

A version of this article first appeared on WebMD.com.

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

A version of this article first appeared on WebMD.com.

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

A version of this article first appeared on WebMD.com.

Allergies to β-lactam antibiotics are among the most documented drug allergies, and approximately 10% of the US population reports an allergy specifically to penicillin.^1,2 Many allergic reactions are mediated via the antibody immunoglobulin E (IgE), producing an immediate hypersensitivity response, such as hives or anaphylaxis, which can be life threatening. Reactions also may be mediated by T cells of the immune system, which target various cell lines and can cause a drug reaction with eosinophilia and systemic symptoms or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).³Although β-lactam and penicillin allergies are frequently reported, < 5% manifest as either an IgE or T-cell–mediated response.⁴Furthermore, for the small proportion of patients who once had a true IgE-mediated reaction, including anaphylaxis, 80% experience a decrease in IgE antibodies over time, resulting in a loss of allergic response after about 10 years.² Due to this decline in IgE response and the initial mislabeling of mild non-IgE penicillin reactions, 95% of patients who are labeled as penicillin-allergic can eventually tolerate a penicillin.²

When a patient’s β-lactam allergy is never reevaluated, negative consequences can ensue. This allergy in a patient’s medical record can lead to the inappropriate avoidance of the entire β-lactam antibiotic class, which includes all penicillins, cephalosporins, and carbapenems. Withholding these antibiotics in certain situations can lead to negative patient outcomes.^5-7 For example, the drugs of choice for the infections syphilis and methicillin-susceptible Staphylococcus aureus (S aureus) are a penicillin or cephalosporin, and patients labeled as penicillin-allergic are more likely to experience treatment failure from using second-line therapies.⁸ Additionally, receiving non-β-lactam antibiotics puts patients at risk of multidrug-resistant pathogens like methicillin-resistant S aureus and vancomycin-resistant Enterococcus (VRE) as well as adverse effects, such as Clostridioides difficile infection.⁹ Using alternative, and likely broad-spectrum, antibiotics also can be financially detrimental: These medications often are more costly than their β-lactam alternatives, and the inappropriate use of therapies can result in longer hospital courses.^9-11

Penicillin allergies can complicate the antibiotic treatment strategy. The Memphis Veterans Affairs Medical Center (MVAMC) in Tennessee recently examined the negative sequelae of β-lactam allergies and found that more than half the patients received inappropriate antibiotics based on guideline recommendations, allergy history, and culture and sensitivity data.¹² To mitigate the problems for patients with β-lactam allergies, the 2016 guidelines from the Infectious Diseases Society of America (IDSA) on the Implementation of Antimicrobial Stewardship Programs (ASP) recommend that these patients undergo allergy assessment and penicillin skin testing.¹³In November 2017, MVAMC implemented such a process. The purpose of this study was to describe our pharmacist-run β-lactam allergy assessment (BLAA) protocol and penicillin allergy clinic (PAC) and evaluate their overall outcomes: the proportion of patients who have been cleared to receive an alternative β-lactam antibiotic or who have had their allergy removed altogether.

Methods

We conducted a retrospective, observational study with approval from the institutional review board at MVAMC. This institution is an academic teaching center with 240 acute care beds and a variety of outpatient clinics available at the main campus, serving veterans in Memphis and the Mid-South area, including west Tennessee, northern Mississippi, and northeastern Arkansas. Patients were consecutively evaluated from November 2017 through February 2020. All MVAMC patients with a documented β-lactam allergy were eligible for inclusion; there were no exclusion criteria. Electronic health record data were assessed and included basic patient demographics, allergy history, and the outcome of the BLAA and PAC. Descriptive statistics were used for data analysis.

The purpose of the BLAA process is to evaluate, clarify, and potentially clear patients of their β-lactam allergies. Started in November 2017, the process includes appropriate patient screening with documentation of the β-lactam allergy. When patients with a β-lactam allergy are admitted to the hospital, they are interviewed by an inpatient CPS. This pharmacist then enters an assessment into the patient’s chart, which includes details of the allergen, reaction, and timing of the event. Based on this information, the CPS provides recommendations: clearance for alternative β-lactams, avoidance of all β-lactams, or removal of the allergy.

In January 2019, the pharmacist-driven penicillin allergy clinic (PAC) was started. Eligible patients receive a skin test to confirm or rule out their allergy after hospital discharge. To facilitate patient identification and screening, the ASP/infectious diseases (ID) clinical pharmacist runs a daily report of hospitalized patients with documented β-lactam allergies. All inpatient CPSs had access to this report and could easily identify and interview patients. Following the interview, the pharmacist enters a note in the patient’s chart, using the BLAA template (eFigures 1 and 2). On completion, a note is viewable in the Notes section adjacent to the patient’s allergies. The pharmacist then can enter a PAC consult for eligible patients. Although most patients qualify for PAC, exclusion criteria include non–IgE-mediated allergies (ie, SJS/TEN), allergies to β-lactams other than penicillins, or recent reactions (ie, within the past 5 years). Each inpatient CPS is trained on this BLAA process, which includes patient screening, chart review, patient interviewing, and the BLAA template and note completion. Pharmacists must demonstrate competency in completing 5 BLAA notes with review from the ASP/ID pharmacist. Once training is completed, this process is integrated into the pharmacist’s everyday workflow.

Results

We evaluated 278 patients, using the BLAA protocol. In this veteran population, patients were generally older males and evenly split between African American and White patients (Table 2). Most patients reported an allergy to penicillin, with a rash being the most common reaction (Table 3).

Of the 278 assessed, 246 patients were evaluated via our BLAA alone and were not seen in PAC. We were able to remove 25% of these patients’ allergies by performing a thorough assessment. Of the 184 patients whose allergies could not be removed via the BLAA alone, 147 (80%) were still eligible for PAC but are awaiting scheduling. Patients ineligible for PAC included those with a cephalosporin allergy or a severe and non–IgE-mediated reaction. Other ineligible patients who were not eligible included those with diseases where risk of testing outweighed the benefits.

Of the 32 patients who were seen in PAC, 75% of allergies were removed through direct testing. No differences between race or gender were observed. Of the 8 patients (25%) whose allergies were not removed, 5 had confirmed penicillin allergies with a positive reaction; 4 of these patients have since tolerated an alternative β-lactam (either a cephalosporin or carbapenem). Three patients had inconclusive tests, most often because their positive control was nonreactive during the percutaneous portion of the skin test; these allergies could neither be confirmed nor removed. Two of these patients have since tolerated alternative β-lactams (both cephalosporins). Although these 8 patients should not be rechallenged with a penicillin antibiotic, they could still be considered for alternative β-lactams, based on the nature and histories of their allergies.

Discussion

We have implemented a unique and efficient way to evaluate, clarify, and clear β-lactam allergies. Our BLAA protocol allows for a smooth process by distributing the workload of evaluating and clarifying patients’ allergies over many inpatient CPS. Furthermore, the BLAA is readily accessible to health care providers (HCPs), allowing for optimal clinical decision making. HCPs can quickly gather further information on the β-lactam allergy, while seeing actionable recommendations, along with documentation of the PAC visit and subsequent events, if the patient has been seen.

This study demonstrated the promotion of alternative β-lactam use for nearly all patients: 99% of our patient population were deemed candidates for a β-lactam type antibiotic. This percentage included patients whose allergies have been fully cleared, both through BLAA alone and in PAC. Also included are patients who have been cleared for an alternative β-lactam and not necessarily a penicillin.

In our PAC, 8 patients were not cleared for penicillins: 5 had penicillin allergies confirmed, and 3 had inconclusive results. Based on the nature of their reactions and previous tolerance of alternative β-lactams, those 5 patients are still eligible for alternative β-lactams. Additionally, the 3 patients with inconclusive results are also eligible for alternative β-lactams for the same reasons. The patients for whom β-lactam antibiotic avoidance was recommended (4 patients, 1%) have not been seen in PAC, as their reactions disqualify them from penicillin skin testing. Two of these patients had anaphylaxis < 5 years ago and will be eligible for PAC if they do not experience anaphylaxis within the 5-year period.

Limitations

Although our study demonstrates many benefits of implementation of a BLAA protocol and PAC, it has several limitations. This analysis was a retrospective review of the limited number of patients who had assessments completed. Additionally, many patients were waiting to be seen in PAC. This delay is largely due to the length of time to establish our pharmacist-run PAC, the limited number of pharmacists trained and available for skin testing, the time constraints of our staff, and COVID-19 pandemic. Additionally, only pharmacists administer the BLAA questionnaire, but this process could be expanded to other professionals such as nursing staff. Also, this study was not set up as a before-and-after analysis that examined outcomes associated with individual patients. Future directions include assessing the clinical impact of this protocol, such as evaluating provider utilization of β-lactam antibiotics for patients with penicillin allergies and determining associated cost savings.

Conclusions

This study demonstrated that implementation of a pharmacist-driven BLAA protocol and PAC can effectively remove inaccurate penicillin allergy labels and clear patients for alternative β-lactam antibiotic use. The BLAA process in conjunction with PAC will continue to be used to better evaluate, clarify, and clear patient allergies to optimize their care.

Allergies to β-lactam antibiotics are among the most documented drug allergies, and approximately 10% of the US population reports an allergy specifically to penicillin.^1,2 Many allergic reactions are mediated via the antibody immunoglobulin E (IgE), producing an immediate hypersensitivity response, such as hives or anaphylaxis, which can be life threatening. Reactions also may be mediated by T cells of the immune system, which target various cell lines and can cause a drug reaction with eosinophilia and systemic symptoms or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).³Although β-lactam and penicillin allergies are frequently reported, < 5% manifest as either an IgE or T-cell–mediated response.⁴Furthermore, for the small proportion of patients who once had a true IgE-mediated reaction, including anaphylaxis, 80% experience a decrease in IgE antibodies over time, resulting in a loss of allergic response after about 10 years.² Due to this decline in IgE response and the initial mislabeling of mild non-IgE penicillin reactions, 95% of patients who are labeled as penicillin-allergic can eventually tolerate a penicillin.²

When a patient’s β-lactam allergy is never reevaluated, negative consequences can ensue. This allergy in a patient’s medical record can lead to the inappropriate avoidance of the entire β-lactam antibiotic class, which includes all penicillins, cephalosporins, and carbapenems. Withholding these antibiotics in certain situations can lead to negative patient outcomes.^5-7 For example, the drugs of choice for the infections syphilis and methicillin-susceptible Staphylococcus aureus (S aureus) are a penicillin or cephalosporin, and patients labeled as penicillin-allergic are more likely to experience treatment failure from using second-line therapies.⁸ Additionally, receiving non-β-lactam antibiotics puts patients at risk of multidrug-resistant pathogens like methicillin-resistant S aureus and vancomycin-resistant Enterococcus (VRE) as well as adverse effects, such as Clostridioides difficile infection.⁹ Using alternative, and likely broad-spectrum, antibiotics also can be financially detrimental: These medications often are more costly than their β-lactam alternatives, and the inappropriate use of therapies can result in longer hospital courses.^9-11

Penicillin allergies can complicate the antibiotic treatment strategy. The Memphis Veterans Affairs Medical Center (MVAMC) in Tennessee recently examined the negative sequelae of β-lactam allergies and found that more than half the patients received inappropriate antibiotics based on guideline recommendations, allergy history, and culture and sensitivity data.¹² To mitigate the problems for patients with β-lactam allergies, the 2016 guidelines from the Infectious Diseases Society of America (IDSA) on the Implementation of Antimicrobial Stewardship Programs (ASP) recommend that these patients undergo allergy assessment and penicillin skin testing.¹³In November 2017, MVAMC implemented such a process. The purpose of this study was to describe our pharmacist-run β-lactam allergy assessment (BLAA) protocol and penicillin allergy clinic (PAC) and evaluate their overall outcomes: the proportion of patients who have been cleared to receive an alternative β-lactam antibiotic or who have had their allergy removed altogether.

Methods

We conducted a retrospective, observational study with approval from the institutional review board at MVAMC. This institution is an academic teaching center with 240 acute care beds and a variety of outpatient clinics available at the main campus, serving veterans in Memphis and the Mid-South area, including west Tennessee, northern Mississippi, and northeastern Arkansas. Patients were consecutively evaluated from November 2017 through February 2020. All MVAMC patients with a documented β-lactam allergy were eligible for inclusion; there were no exclusion criteria. Electronic health record data were assessed and included basic patient demographics, allergy history, and the outcome of the BLAA and PAC. Descriptive statistics were used for data analysis.

The purpose of the BLAA process is to evaluate, clarify, and potentially clear patients of their β-lactam allergies. Started in November 2017, the process includes appropriate patient screening with documentation of the β-lactam allergy. When patients with a β-lactam allergy are admitted to the hospital, they are interviewed by an inpatient CPS. This pharmacist then enters an assessment into the patient’s chart, which includes details of the allergen, reaction, and timing of the event. Based on this information, the CPS provides recommendations: clearance for alternative β-lactams, avoidance of all β-lactams, or removal of the allergy.

In January 2019, the pharmacist-driven penicillin allergy clinic (PAC) was started. Eligible patients receive a skin test to confirm or rule out their allergy after hospital discharge. To facilitate patient identification and screening, the ASP/infectious diseases (ID) clinical pharmacist runs a daily report of hospitalized patients with documented β-lactam allergies. All inpatient CPSs had access to this report and could easily identify and interview patients. Following the interview, the pharmacist enters a note in the patient’s chart, using the BLAA template (eFigures 1 and 2). On completion, a note is viewable in the Notes section adjacent to the patient’s allergies. The pharmacist then can enter a PAC consult for eligible patients. Although most patients qualify for PAC, exclusion criteria include non–IgE-mediated allergies (ie, SJS/TEN), allergies to β-lactams other than penicillins, or recent reactions (ie, within the past 5 years). Each inpatient CPS is trained on this BLAA process, which includes patient screening, chart review, patient interviewing, and the BLAA template and note completion. Pharmacists must demonstrate competency in completing 5 BLAA notes with review from the ASP/ID pharmacist. Once training is completed, this process is integrated into the pharmacist’s everyday workflow.

Results

We evaluated 278 patients, using the BLAA protocol. In this veteran population, patients were generally older males and evenly split between African American and White patients (Table 2). Most patients reported an allergy to penicillin, with a rash being the most common reaction (Table 3).

Of the 278 assessed, 246 patients were evaluated via our BLAA alone and were not seen in PAC. We were able to remove 25% of these patients’ allergies by performing a thorough assessment. Of the 184 patients whose allergies could not be removed via the BLAA alone, 147 (80%) were still eligible for PAC but are awaiting scheduling. Patients ineligible for PAC included those with a cephalosporin allergy or a severe and non–IgE-mediated reaction. Other ineligible patients who were not eligible included those with diseases where risk of testing outweighed the benefits.

Of the 32 patients who were seen in PAC, 75% of allergies were removed through direct testing. No differences between race or gender were observed. Of the 8 patients (25%) whose allergies were not removed, 5 had confirmed penicillin allergies with a positive reaction; 4 of these patients have since tolerated an alternative β-lactam (either a cephalosporin or carbapenem). Three patients had inconclusive tests, most often because their positive control was nonreactive during the percutaneous portion of the skin test; these allergies could neither be confirmed nor removed. Two of these patients have since tolerated alternative β-lactams (both cephalosporins). Although these 8 patients should not be rechallenged with a penicillin antibiotic, they could still be considered for alternative β-lactams, based on the nature and histories of their allergies.

Discussion

We have implemented a unique and efficient way to evaluate, clarify, and clear β-lactam allergies. Our BLAA protocol allows for a smooth process by distributing the workload of evaluating and clarifying patients’ allergies over many inpatient CPS. Furthermore, the BLAA is readily accessible to health care providers (HCPs), allowing for optimal clinical decision making. HCPs can quickly gather further information on the β-lactam allergy, while seeing actionable recommendations, along with documentation of the PAC visit and subsequent events, if the patient has been seen.

This study demonstrated the promotion of alternative β-lactam use for nearly all patients: 99% of our patient population were deemed candidates for a β-lactam type antibiotic. This percentage included patients whose allergies have been fully cleared, both through BLAA alone and in PAC. Also included are patients who have been cleared for an alternative β-lactam and not necessarily a penicillin.

In our PAC, 8 patients were not cleared for penicillins: 5 had penicillin allergies confirmed, and 3 had inconclusive results. Based on the nature of their reactions and previous tolerance of alternative β-lactams, those 5 patients are still eligible for alternative β-lactams. Additionally, the 3 patients with inconclusive results are also eligible for alternative β-lactams for the same reasons. The patients for whom β-lactam antibiotic avoidance was recommended (4 patients, 1%) have not been seen in PAC, as their reactions disqualify them from penicillin skin testing. Two of these patients had anaphylaxis < 5 years ago and will be eligible for PAC if they do not experience anaphylaxis within the 5-year period.

Limitations

Although our study demonstrates many benefits of implementation of a BLAA protocol and PAC, it has several limitations. This analysis was a retrospective review of the limited number of patients who had assessments completed. Additionally, many patients were waiting to be seen in PAC. This delay is largely due to the length of time to establish our pharmacist-run PAC, the limited number of pharmacists trained and available for skin testing, the time constraints of our staff, and COVID-19 pandemic. Additionally, only pharmacists administer the BLAA questionnaire, but this process could be expanded to other professionals such as nursing staff. Also, this study was not set up as a before-and-after analysis that examined outcomes associated with individual patients. Future directions include assessing the clinical impact of this protocol, such as evaluating provider utilization of β-lactam antibiotics for patients with penicillin allergies and determining associated cost savings.

Conclusions

This study demonstrated that implementation of a pharmacist-driven BLAA protocol and PAC can effectively remove inaccurate penicillin allergy labels and clear patients for alternative β-lactam antibiotic use. The BLAA process in conjunction with PAC will continue to be used to better evaluate, clarify, and clear patient allergies to optimize their care.

Allergies to β-lactam antibiotics are among the most documented drug allergies, and approximately 10% of the US population reports an allergy specifically to penicillin.^1,2 Many allergic reactions are mediated via the antibody immunoglobulin E (IgE), producing an immediate hypersensitivity response, such as hives or anaphylaxis, which can be life threatening. Reactions also may be mediated by T cells of the immune system, which target various cell lines and can cause a drug reaction with eosinophilia and systemic symptoms or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).³Although β-lactam and penicillin allergies are frequently reported, < 5% manifest as either an IgE or T-cell–mediated response.⁴Furthermore, for the small proportion of patients who once had a true IgE-mediated reaction, including anaphylaxis, 80% experience a decrease in IgE antibodies over time, resulting in a loss of allergic response after about 10 years.² Due to this decline in IgE response and the initial mislabeling of mild non-IgE penicillin reactions, 95% of patients who are labeled as penicillin-allergic can eventually tolerate a penicillin.²

When a patient’s β-lactam allergy is never reevaluated, negative consequences can ensue. This allergy in a patient’s medical record can lead to the inappropriate avoidance of the entire β-lactam antibiotic class, which includes all penicillins, cephalosporins, and carbapenems. Withholding these antibiotics in certain situations can lead to negative patient outcomes.^5-7 For example, the drugs of choice for the infections syphilis and methicillin-susceptible Staphylococcus aureus (S aureus) are a penicillin or cephalosporin, and patients labeled as penicillin-allergic are more likely to experience treatment failure from using second-line therapies.⁸ Additionally, receiving non-β-lactam antibiotics puts patients at risk of multidrug-resistant pathogens like methicillin-resistant S aureus and vancomycin-resistant Enterococcus (VRE) as well as adverse effects, such as Clostridioides difficile infection.⁹ Using alternative, and likely broad-spectrum, antibiotics also can be financially detrimental: These medications often are more costly than their β-lactam alternatives, and the inappropriate use of therapies can result in longer hospital courses.^9-11

Penicillin allergies can complicate the antibiotic treatment strategy. The Memphis Veterans Affairs Medical Center (MVAMC) in Tennessee recently examined the negative sequelae of β-lactam allergies and found that more than half the patients received inappropriate antibiotics based on guideline recommendations, allergy history, and culture and sensitivity data.¹² To mitigate the problems for patients with β-lactam allergies, the 2016 guidelines from the Infectious Diseases Society of America (IDSA) on the Implementation of Antimicrobial Stewardship Programs (ASP) recommend that these patients undergo allergy assessment and penicillin skin testing.¹³In November 2017, MVAMC implemented such a process. The purpose of this study was to describe our pharmacist-run β-lactam allergy assessment (BLAA) protocol and penicillin allergy clinic (PAC) and evaluate their overall outcomes: the proportion of patients who have been cleared to receive an alternative β-lactam antibiotic or who have had their allergy removed altogether.

Methods

We conducted a retrospective, observational study with approval from the institutional review board at MVAMC. This institution is an academic teaching center with 240 acute care beds and a variety of outpatient clinics available at the main campus, serving veterans in Memphis and the Mid-South area, including west Tennessee, northern Mississippi, and northeastern Arkansas. Patients were consecutively evaluated from November 2017 through February 2020. All MVAMC patients with a documented β-lactam allergy were eligible for inclusion; there were no exclusion criteria. Electronic health record data were assessed and included basic patient demographics, allergy history, and the outcome of the BLAA and PAC. Descriptive statistics were used for data analysis.

The purpose of the BLAA process is to evaluate, clarify, and potentially clear patients of their β-lactam allergies. Started in November 2017, the process includes appropriate patient screening with documentation of the β-lactam allergy. When patients with a β-lactam allergy are admitted to the hospital, they are interviewed by an inpatient CPS. This pharmacist then enters an assessment into the patient’s chart, which includes details of the allergen, reaction, and timing of the event. Based on this information, the CPS provides recommendations: clearance for alternative β-lactams, avoidance of all β-lactams, or removal of the allergy.

In January 2019, the pharmacist-driven penicillin allergy clinic (PAC) was started. Eligible patients receive a skin test to confirm or rule out their allergy after hospital discharge. To facilitate patient identification and screening, the ASP/infectious diseases (ID) clinical pharmacist runs a daily report of hospitalized patients with documented β-lactam allergies. All inpatient CPSs had access to this report and could easily identify and interview patients. Following the interview, the pharmacist enters a note in the patient’s chart, using the BLAA template (eFigures 1 and 2). On completion, a note is viewable in the Notes section adjacent to the patient’s allergies. The pharmacist then can enter a PAC consult for eligible patients. Although most patients qualify for PAC, exclusion criteria include non–IgE-mediated allergies (ie, SJS/TEN), allergies to β-lactams other than penicillins, or recent reactions (ie, within the past 5 years). Each inpatient CPS is trained on this BLAA process, which includes patient screening, chart review, patient interviewing, and the BLAA template and note completion. Pharmacists must demonstrate competency in completing 5 BLAA notes with review from the ASP/ID pharmacist. Once training is completed, this process is integrated into the pharmacist’s everyday workflow.

Results

We evaluated 278 patients, using the BLAA protocol. In this veteran population, patients were generally older males and evenly split between African American and White patients (Table 2). Most patients reported an allergy to penicillin, with a rash being the most common reaction (Table 3).

Of the 278 assessed, 246 patients were evaluated via our BLAA alone and were not seen in PAC. We were able to remove 25% of these patients’ allergies by performing a thorough assessment. Of the 184 patients whose allergies could not be removed via the BLAA alone, 147 (80%) were still eligible for PAC but are awaiting scheduling. Patients ineligible for PAC included those with a cephalosporin allergy or a severe and non–IgE-mediated reaction. Other ineligible patients who were not eligible included those with diseases where risk of testing outweighed the benefits.

Of the 32 patients who were seen in PAC, 75% of allergies were removed through direct testing. No differences between race or gender were observed. Of the 8 patients (25%) whose allergies were not removed, 5 had confirmed penicillin allergies with a positive reaction; 4 of these patients have since tolerated an alternative β-lactam (either a cephalosporin or carbapenem). Three patients had inconclusive tests, most often because their positive control was nonreactive during the percutaneous portion of the skin test; these allergies could neither be confirmed nor removed. Two of these patients have since tolerated alternative β-lactams (both cephalosporins). Although these 8 patients should not be rechallenged with a penicillin antibiotic, they could still be considered for alternative β-lactams, based on the nature and histories of their allergies.

Discussion

We have implemented a unique and efficient way to evaluate, clarify, and clear β-lactam allergies. Our BLAA protocol allows for a smooth process by distributing the workload of evaluating and clarifying patients’ allergies over many inpatient CPS. Furthermore, the BLAA is readily accessible to health care providers (HCPs), allowing for optimal clinical decision making. HCPs can quickly gather further information on the β-lactam allergy, while seeing actionable recommendations, along with documentation of the PAC visit and subsequent events, if the patient has been seen.

This study demonstrated the promotion of alternative β-lactam use for nearly all patients: 99% of our patient population were deemed candidates for a β-lactam type antibiotic. This percentage included patients whose allergies have been fully cleared, both through BLAA alone and in PAC. Also included are patients who have been cleared for an alternative β-lactam and not necessarily a penicillin.

In our PAC, 8 patients were not cleared for penicillins: 5 had penicillin allergies confirmed, and 3 had inconclusive results. Based on the nature of their reactions and previous tolerance of alternative β-lactams, those 5 patients are still eligible for alternative β-lactams. Additionally, the 3 patients with inconclusive results are also eligible for alternative β-lactams for the same reasons. The patients for whom β-lactam antibiotic avoidance was recommended (4 patients, 1%) have not been seen in PAC, as their reactions disqualify them from penicillin skin testing. Two of these patients had anaphylaxis < 5 years ago and will be eligible for PAC if they do not experience anaphylaxis within the 5-year period.

Limitations

Although our study demonstrates many benefits of implementation of a BLAA protocol and PAC, it has several limitations. This analysis was a retrospective review of the limited number of patients who had assessments completed. Additionally, many patients were waiting to be seen in PAC. This delay is largely due to the length of time to establish our pharmacist-run PAC, the limited number of pharmacists trained and available for skin testing, the time constraints of our staff, and COVID-19 pandemic. Additionally, only pharmacists administer the BLAA questionnaire, but this process could be expanded to other professionals such as nursing staff. Also, this study was not set up as a before-and-after analysis that examined outcomes associated with individual patients. Future directions include assessing the clinical impact of this protocol, such as evaluating provider utilization of β-lactam antibiotics for patients with penicillin allergies and determining associated cost savings.

Conclusions

This study demonstrated that implementation of a pharmacist-driven BLAA protocol and PAC can effectively remove inaccurate penicillin allergy labels and clear patients for alternative β-lactam antibiotic use. The BLAA process in conjunction with PAC will continue to be used to better evaluate, clarify, and clear patient allergies to optimize their care.

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

A version of this article first appeared on Medscape.com.

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

A version of this article first appeared on Medscape.com.

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

A version of this article first appeared on Medscape.com.

Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.¹ In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.² By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.³ Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.

Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.⁴ Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.³ Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.⁵ A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.⁶ Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.

Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.

Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.

The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.

Quality Improvement Project

This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.⁷ This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1 

Program Inclusion

Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.

Implementation

Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.

Observations

Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.

Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.

Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P aeruginosa (29%) was identified in 4 cases. Other organisms included P mirabilis (14%) in 2 patients and streptococcus species (14%) in 2 cases. Enterococcus faecium (7%) was isolated in 1 case.

Discussion

This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.

Limitations

The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.

The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.

Future Directions

Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.

On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.

Conclusions

This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.

This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.

Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.

Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.¹ In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.² By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.³ Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.

Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.⁴ Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.³ Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.⁵ A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.⁶ Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.

Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.

Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.

The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.

Quality Improvement Project

This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.⁷ This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1 

Program Inclusion

Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.

Implementation

Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.

Observations

Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.

Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.

Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P aeruginosa (29%) was identified in 4 cases. Other organisms included P mirabilis (14%) in 2 patients and streptococcus species (14%) in 2 cases. Enterococcus faecium (7%) was isolated in 1 case.

Discussion

This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.

Limitations

The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.

The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.

Future Directions

Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.

On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.

Conclusions

This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.

This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.

Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.

Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.¹ In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.² By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.³ Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.

Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.⁴ Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.³ Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.⁵ A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.⁶ Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.

Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.

Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.

The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.

Quality Improvement Project

This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.⁷ This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1 

Program Inclusion

Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.

Implementation

Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.

Observations

Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.

Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.

Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P aeruginosa (29%) was identified in 4 cases. Other organisms included P mirabilis (14%) in 2 patients and streptococcus species (14%) in 2 cases. Enterococcus faecium (7%) was isolated in 1 case.

Discussion

This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.

Limitations

The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.

The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.

Future Directions

Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.

On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.

Conclusions

This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.

This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.

Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.

We present a case of an orbital varix masquerading as an orbital lymphoma. Our case underscores the importance of clinical correlation and thorough study of the ordered films by the ordering health care provider.

Case Presentation

An 84-year-old female veteran presented to the Bay Pines Veterans Affairs Healthcare System emergency department. She had a past ocular history of nonproliferative diabetic retinopathy in both eyes (OU) and senile cataracts OU. She had a complicated medical history most notable for congestive heart failure and Stage IV B cell follicular lymphoma, having received 6 rounds of chemotherapy, and has since been on rituximab maintenance therapy for the past few years.

The patient reported dyspnea on exertion, 30-pound weight gain, and ocular pain in her right eye (OD), more so than her left eye (OS) that was severe enough to wake her from sleep. She endorsed an associated headache but reported no visual loss or any other ocular symptoms other than conjunctival injection. On examination, the patient demonstrated jugular venous distension. X-ray imaging obtained in the emergency department demonstrated bilateral pleural effusions. Our patient was admitted subsequently for an exacerbation of congestive heart failure. She was monitored for euvolemia and discharged 4 days later.

During admission, imaging of the orbits was obtained. Computed tomography (CT) of the head without contrast demonstrated at least 4 intraorbital masses in the right orbit, measuring up to 22 mm in maximum diameter and at least 3 intraorbital masses in the left orbit, measuring up to 16 mm in diameter (Figure 1). Magnetic resonance imaging (MRI) with contrast of the brain and orbits was ordered, which demonstrated multiple bilateral uniformly enhancing, primarily extraconal masses present in both orbits, the largest of which occupied the superomedial aspect of the right orbit and measured 12 x 18 x 20 mm. Further, the ophthalmic veins were noted to be engorged. The cavernous did not demonstrate any thrombosis. No other ocular structures were compromised, although there was compression of the extraocular muscles in both orbits (Figures 2, 3, 4, 5, and 6). At that time, the reading radiologist suggested the most likely diagnosis was metastatic orbital lymphoma given the clinical history, which became the working diagnosis.

Discussion

In a study of 242 patients, Bacorn and colleagues found that a clinician’s preoperative assessment correlated with histopathologic diagnosis in 75.7% of cases, whereas the radiology report was correct in only 52.4% of cases.¹ Retrospective analysis identified clues that could have been used to more rapidly elucidate the true diagnosis for our patient.

In regard to symptomatology, orbital varices present with intermittent proptosis, vision loss, and rarely, periorbital pain unless thrombosed.^2,3 The severity of periorbital pain experienced by our patient is atypical of an orbital varix especially in the absence of a phlebolith. A specific feature of orbital varix is enlargement with the Valsalva maneuver.³ Although the patient did not report the notedsymptoms, more pointed questioning may have helped elucidate our patient’s true diagnosis sooner.

Radiologically, the presence of a partial flow void (decreased signal on T2) is useful for confirming the vascular nature of a lesion as was present in our case. Specific to the radiologic evaluation of orbital varices, it is recommended to obtain imaging with and without the Valsalva maneuver.⁴ Ultrasound is a superb tool in our armamentarium to image orbital lesions. B-scan ultrasound with and without Valsalva should be able to demonstrate variation in size when standing (minimal distension) vs lying flat with Valsalva (maximal distension).⁴ Further, Doppler ultrasound would be able to demonstrate changes in flow within the lesion when comparing previously mentioned maneuvers.⁴ Orbital lymphoma would not demonstrate this variation.

The size change of an orbital varix lesion may be further demonstrated on head CT with contrast. On CT, an orbital varix will demonstrate isodensity to other venous structures, whereas orbital lymphomas will be hyperdense when compared to extraocular muscles.^4,5 Further, a head CT without contrast may demonstrate phleboliths within an orbital varix.⁴ MRI should be performed with the Valsalva maneuver. On T1 and T2 studies, orbital varices demonstrate hypointensity when compared to extraocular muscles (EOMs).⁴ Lymphomas demonstrate a very specific radiologic pattern on MRI. On T1, they demonstrate isointensity to hypointensity when compared to EOMS, and on T2, they demonstrate iso- to hyperintensity when compared to EOMs.⁵ With respect to fluorodeoxyglucose (FDG) positron emission tomography (PET), our patient’s orbital lesion did not demonstrate FDG uptake. In patients where lymphoma previously demonstrated FDG PET uptake, the absence of such uptake strongly argues against malignant nature of the lesion (Figure 7).

Conclusions

We present a case of an orbital varix masquerading as an orbital lymphoma. While the ruling out of a diagnosis that might portend a poor prognosis is always of paramount importance, proper use of investigative studies and a thorough history could have helped elucidate the true diagnosis sooner: In this case an orbital varix masquerading as an orbital lymphoma. Mainly, the use of the Valsalva maneuver during the physical examination (resulting in proptosis) and during radiologic studies might have obviated the need for formal biopsy. Furthermore, orbital pain may be a presenting symptom of fluid overload in patients with a history of orbital varices.

We present a case of an orbital varix masquerading as an orbital lymphoma. Our case underscores the importance of clinical correlation and thorough study of the ordered films by the ordering health care provider.

Case Presentation

An 84-year-old female veteran presented to the Bay Pines Veterans Affairs Healthcare System emergency department. She had a past ocular history of nonproliferative diabetic retinopathy in both eyes (OU) and senile cataracts OU. She had a complicated medical history most notable for congestive heart failure and Stage IV B cell follicular lymphoma, having received 6 rounds of chemotherapy, and has since been on rituximab maintenance therapy for the past few years.

The patient reported dyspnea on exertion, 30-pound weight gain, and ocular pain in her right eye (OD), more so than her left eye (OS) that was severe enough to wake her from sleep. She endorsed an associated headache but reported no visual loss or any other ocular symptoms other than conjunctival injection. On examination, the patient demonstrated jugular venous distension. X-ray imaging obtained in the emergency department demonstrated bilateral pleural effusions. Our patient was admitted subsequently for an exacerbation of congestive heart failure. She was monitored for euvolemia and discharged 4 days later.

During admission, imaging of the orbits was obtained. Computed tomography (CT) of the head without contrast demonstrated at least 4 intraorbital masses in the right orbit, measuring up to 22 mm in maximum diameter and at least 3 intraorbital masses in the left orbit, measuring up to 16 mm in diameter (Figure 1). Magnetic resonance imaging (MRI) with contrast of the brain and orbits was ordered, which demonstrated multiple bilateral uniformly enhancing, primarily extraconal masses present in both orbits, the largest of which occupied the superomedial aspect of the right orbit and measured 12 x 18 x 20 mm. Further, the ophthalmic veins were noted to be engorged. The cavernous did not demonstrate any thrombosis. No other ocular structures were compromised, although there was compression of the extraocular muscles in both orbits (Figures 2, 3, 4, 5, and 6). At that time, the reading radiologist suggested the most likely diagnosis was metastatic orbital lymphoma given the clinical history, which became the working diagnosis.

Discussion

In a study of 242 patients, Bacorn and colleagues found that a clinician’s preoperative assessment correlated with histopathologic diagnosis in 75.7% of cases, whereas the radiology report was correct in only 52.4% of cases.¹ Retrospective analysis identified clues that could have been used to more rapidly elucidate the true diagnosis for our patient.

In regard to symptomatology, orbital varices present with intermittent proptosis, vision loss, and rarely, periorbital pain unless thrombosed.^2,3 The severity of periorbital pain experienced by our patient is atypical of an orbital varix especially in the absence of a phlebolith. A specific feature of orbital varix is enlargement with the Valsalva maneuver.³ Although the patient did not report the notedsymptoms, more pointed questioning may have helped elucidate our patient’s true diagnosis sooner.

Radiologically, the presence of a partial flow void (decreased signal on T2) is useful for confirming the vascular nature of a lesion as was present in our case. Specific to the radiologic evaluation of orbital varices, it is recommended to obtain imaging with and without the Valsalva maneuver.⁴ Ultrasound is a superb tool in our armamentarium to image orbital lesions. B-scan ultrasound with and without Valsalva should be able to demonstrate variation in size when standing (minimal distension) vs lying flat with Valsalva (maximal distension).⁴ Further, Doppler ultrasound would be able to demonstrate changes in flow within the lesion when comparing previously mentioned maneuvers.⁴ Orbital lymphoma would not demonstrate this variation.

The size change of an orbital varix lesion may be further demonstrated on head CT with contrast. On CT, an orbital varix will demonstrate isodensity to other venous structures, whereas orbital lymphomas will be hyperdense when compared to extraocular muscles.^4,5 Further, a head CT without contrast may demonstrate phleboliths within an orbital varix.⁴ MRI should be performed with the Valsalva maneuver. On T1 and T2 studies, orbital varices demonstrate hypointensity when compared to extraocular muscles (EOMs).⁴ Lymphomas demonstrate a very specific radiologic pattern on MRI. On T1, they demonstrate isointensity to hypointensity when compared to EOMS, and on T2, they demonstrate iso- to hyperintensity when compared to EOMs.⁵ With respect to fluorodeoxyglucose (FDG) positron emission tomography (PET), our patient’s orbital lesion did not demonstrate FDG uptake. In patients where lymphoma previously demonstrated FDG PET uptake, the absence of such uptake strongly argues against malignant nature of the lesion (Figure 7).

Conclusions

We present a case of an orbital varix masquerading as an orbital lymphoma. While the ruling out of a diagnosis that might portend a poor prognosis is always of paramount importance, proper use of investigative studies and a thorough history could have helped elucidate the true diagnosis sooner: In this case an orbital varix masquerading as an orbital lymphoma. Mainly, the use of the Valsalva maneuver during the physical examination (resulting in proptosis) and during radiologic studies might have obviated the need for formal biopsy. Furthermore, orbital pain may be a presenting symptom of fluid overload in patients with a history of orbital varices.

We present a case of an orbital varix masquerading as an orbital lymphoma. Our case underscores the importance of clinical correlation and thorough study of the ordered films by the ordering health care provider.

Case Presentation

An 84-year-old female veteran presented to the Bay Pines Veterans Affairs Healthcare System emergency department. She had a past ocular history of nonproliferative diabetic retinopathy in both eyes (OU) and senile cataracts OU. She had a complicated medical history most notable for congestive heart failure and Stage IV B cell follicular lymphoma, having received 6 rounds of chemotherapy, and has since been on rituximab maintenance therapy for the past few years.

The patient reported dyspnea on exertion, 30-pound weight gain, and ocular pain in her right eye (OD), more so than her left eye (OS) that was severe enough to wake her from sleep. She endorsed an associated headache but reported no visual loss or any other ocular symptoms other than conjunctival injection. On examination, the patient demonstrated jugular venous distension. X-ray imaging obtained in the emergency department demonstrated bilateral pleural effusions. Our patient was admitted subsequently for an exacerbation of congestive heart failure. She was monitored for euvolemia and discharged 4 days later.

During admission, imaging of the orbits was obtained. Computed tomography (CT) of the head without contrast demonstrated at least 4 intraorbital masses in the right orbit, measuring up to 22 mm in maximum diameter and at least 3 intraorbital masses in the left orbit, measuring up to 16 mm in diameter (Figure 1). Magnetic resonance imaging (MRI) with contrast of the brain and orbits was ordered, which demonstrated multiple bilateral uniformly enhancing, primarily extraconal masses present in both orbits, the largest of which occupied the superomedial aspect of the right orbit and measured 12 x 18 x 20 mm. Further, the ophthalmic veins were noted to be engorged. The cavernous did not demonstrate any thrombosis. No other ocular structures were compromised, although there was compression of the extraocular muscles in both orbits (Figures 2, 3, 4, 5, and 6). At that time, the reading radiologist suggested the most likely diagnosis was metastatic orbital lymphoma given the clinical history, which became the working diagnosis.

Discussion

In a study of 242 patients, Bacorn and colleagues found that a clinician’s preoperative assessment correlated with histopathologic diagnosis in 75.7% of cases, whereas the radiology report was correct in only 52.4% of cases.¹ Retrospective analysis identified clues that could have been used to more rapidly elucidate the true diagnosis for our patient.

In regard to symptomatology, orbital varices present with intermittent proptosis, vision loss, and rarely, periorbital pain unless thrombosed.^2,3 The severity of periorbital pain experienced by our patient is atypical of an orbital varix especially in the absence of a phlebolith. A specific feature of orbital varix is enlargement with the Valsalva maneuver.³ Although the patient did not report the notedsymptoms, more pointed questioning may have helped elucidate our patient’s true diagnosis sooner.

Radiologically, the presence of a partial flow void (decreased signal on T2) is useful for confirming the vascular nature of a lesion as was present in our case. Specific to the radiologic evaluation of orbital varices, it is recommended to obtain imaging with and without the Valsalva maneuver.⁴ Ultrasound is a superb tool in our armamentarium to image orbital lesions. B-scan ultrasound with and without Valsalva should be able to demonstrate variation in size when standing (minimal distension) vs lying flat with Valsalva (maximal distension).⁴ Further, Doppler ultrasound would be able to demonstrate changes in flow within the lesion when comparing previously mentioned maneuvers.⁴ Orbital lymphoma would not demonstrate this variation.

The size change of an orbital varix lesion may be further demonstrated on head CT with contrast. On CT, an orbital varix will demonstrate isodensity to other venous structures, whereas orbital lymphomas will be hyperdense when compared to extraocular muscles.^4,5 Further, a head CT without contrast may demonstrate phleboliths within an orbital varix.⁴ MRI should be performed with the Valsalva maneuver. On T1 and T2 studies, orbital varices demonstrate hypointensity when compared to extraocular muscles (EOMs).⁴ Lymphomas demonstrate a very specific radiologic pattern on MRI. On T1, they demonstrate isointensity to hypointensity when compared to EOMS, and on T2, they demonstrate iso- to hyperintensity when compared to EOMs.⁵ With respect to fluorodeoxyglucose (FDG) positron emission tomography (PET), our patient’s orbital lesion did not demonstrate FDG uptake. In patients where lymphoma previously demonstrated FDG PET uptake, the absence of such uptake strongly argues against malignant nature of the lesion (Figure 7).

Conclusions

We present a case of an orbital varix masquerading as an orbital lymphoma. While the ruling out of a diagnosis that might portend a poor prognosis is always of paramount importance, proper use of investigative studies and a thorough history could have helped elucidate the true diagnosis sooner: In this case an orbital varix masquerading as an orbital lymphoma. Mainly, the use of the Valsalva maneuver during the physical examination (resulting in proptosis) and during radiologic studies might have obviated the need for formal biopsy. Furthermore, orbital pain may be a presenting symptom of fluid overload in patients with a history of orbital varices.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.