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Investing in the future of GI
This leads to promising investigators walking away from GI research frustrated by a lack of support. Investigators in the early stages of their careers are particularly hard hit.
Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field – clinicians and researchers alike – have benefited from discoveries made by dedicated investigators, past and present.
Creative young researchers are poised to make groundbreaking discoveries that will shape the future of gastroenterology. Unfortunately, declining government funding for biomedical research puts this potential in jeopardy. We’re at risk of losing an entire generation of researchers if we don’t act now.
To fill this gap, the AGA Research Foundation invites you to support young investigators’ research careers, allowing them to make discoveries that could ultimately improve patient care and even cure diseases.
“We are at the threshold of key research advances that will cure digestive diseases. We have the manpower, we have trained the people, now we need to have the security that they can stay in research and advance these cures,” said Kim Elaine Barrett, PhD, AGAF, AGA legacy society donor and AGA governing board member.
By joining others in supporting the AGA Research Foundation, you will ensure that young researchers have opportunities to continue their life-saving work.
Learn more or make a contribution at www.foundation.gastro.org.
This leads to promising investigators walking away from GI research frustrated by a lack of support. Investigators in the early stages of their careers are particularly hard hit.
Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field – clinicians and researchers alike – have benefited from discoveries made by dedicated investigators, past and present.
Creative young researchers are poised to make groundbreaking discoveries that will shape the future of gastroenterology. Unfortunately, declining government funding for biomedical research puts this potential in jeopardy. We’re at risk of losing an entire generation of researchers if we don’t act now.
To fill this gap, the AGA Research Foundation invites you to support young investigators’ research careers, allowing them to make discoveries that could ultimately improve patient care and even cure diseases.
“We are at the threshold of key research advances that will cure digestive diseases. We have the manpower, we have trained the people, now we need to have the security that they can stay in research and advance these cures,” said Kim Elaine Barrett, PhD, AGAF, AGA legacy society donor and AGA governing board member.
By joining others in supporting the AGA Research Foundation, you will ensure that young researchers have opportunities to continue their life-saving work.
Learn more or make a contribution at www.foundation.gastro.org.
This leads to promising investigators walking away from GI research frustrated by a lack of support. Investigators in the early stages of their careers are particularly hard hit.
Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field – clinicians and researchers alike – have benefited from discoveries made by dedicated investigators, past and present.
Creative young researchers are poised to make groundbreaking discoveries that will shape the future of gastroenterology. Unfortunately, declining government funding for biomedical research puts this potential in jeopardy. We’re at risk of losing an entire generation of researchers if we don’t act now.
To fill this gap, the AGA Research Foundation invites you to support young investigators’ research careers, allowing them to make discoveries that could ultimately improve patient care and even cure diseases.
“We are at the threshold of key research advances that will cure digestive diseases. We have the manpower, we have trained the people, now we need to have the security that they can stay in research and advance these cures,” said Kim Elaine Barrett, PhD, AGAF, AGA legacy society donor and AGA governing board member.
By joining others in supporting the AGA Research Foundation, you will ensure that young researchers have opportunities to continue their life-saving work.
Learn more or make a contribution at www.foundation.gastro.org.
Trailblazer for women in gastroenterology, Dr. Barbara H. Jung takes over as AGA president
She currently serves as the first woman Robert G. Petersdorf professor and chair of internal medicine at the University of Washington, Seattle, and is the fourth woman to lead the American Gastroenterological Association as its president.
Dr. Jung is an international expert in the field of transforming growth factor–beta superfamily signaling in colon cancer and has made significant contributions at AGA prior to becoming president, most recently as a member of the finance and operations committee, chair-elect of the audit committee and vice chair of the AGA Research Foundation.
Born in Portland, Ore., and raised in Munich, Germany, Dr. Jung’s parents provided unconditional support for her career choice in medicine and nurtured her leadership skills throughout her childhood.
Her academic career began at Ludwig Maximilians University of Munich followed by postdoctoral studies in colon cancer at the Sidney Kimmel Cancer Center in San Diego and eventually culminating in an internal medicine residency at the University of California, San Diego.
Dr. Jung joined the AGA Governing Board in June 2021 as vice president and served as president-elect prior to assuming the top leadership role. Over her time as an AGA member (which started during fellowship), Dr. Jung has also served on the AGA Audit Committee, AGA Registry Research and Publications Committee, AGA Research Policy Committee, and AGA Innovation and Technology Task Force. In 2017, she co-organized the AGA Academic Skills Workshop to train the next generation of gastroenterologists.
She currently serves as the first woman Robert G. Petersdorf professor and chair of internal medicine at the University of Washington, Seattle, and is the fourth woman to lead the American Gastroenterological Association as its president.
Dr. Jung is an international expert in the field of transforming growth factor–beta superfamily signaling in colon cancer and has made significant contributions at AGA prior to becoming president, most recently as a member of the finance and operations committee, chair-elect of the audit committee and vice chair of the AGA Research Foundation.
Born in Portland, Ore., and raised in Munich, Germany, Dr. Jung’s parents provided unconditional support for her career choice in medicine and nurtured her leadership skills throughout her childhood.
Her academic career began at Ludwig Maximilians University of Munich followed by postdoctoral studies in colon cancer at the Sidney Kimmel Cancer Center in San Diego and eventually culminating in an internal medicine residency at the University of California, San Diego.
Dr. Jung joined the AGA Governing Board in June 2021 as vice president and served as president-elect prior to assuming the top leadership role. Over her time as an AGA member (which started during fellowship), Dr. Jung has also served on the AGA Audit Committee, AGA Registry Research and Publications Committee, AGA Research Policy Committee, and AGA Innovation and Technology Task Force. In 2017, she co-organized the AGA Academic Skills Workshop to train the next generation of gastroenterologists.
She currently serves as the first woman Robert G. Petersdorf professor and chair of internal medicine at the University of Washington, Seattle, and is the fourth woman to lead the American Gastroenterological Association as its president.
Dr. Jung is an international expert in the field of transforming growth factor–beta superfamily signaling in colon cancer and has made significant contributions at AGA prior to becoming president, most recently as a member of the finance and operations committee, chair-elect of the audit committee and vice chair of the AGA Research Foundation.
Born in Portland, Ore., and raised in Munich, Germany, Dr. Jung’s parents provided unconditional support for her career choice in medicine and nurtured her leadership skills throughout her childhood.
Her academic career began at Ludwig Maximilians University of Munich followed by postdoctoral studies in colon cancer at the Sidney Kimmel Cancer Center in San Diego and eventually culminating in an internal medicine residency at the University of California, San Diego.
Dr. Jung joined the AGA Governing Board in June 2021 as vice president and served as president-elect prior to assuming the top leadership role. Over her time as an AGA member (which started during fellowship), Dr. Jung has also served on the AGA Audit Committee, AGA Registry Research and Publications Committee, AGA Research Policy Committee, and AGA Innovation and Technology Task Force. In 2017, she co-organized the AGA Academic Skills Workshop to train the next generation of gastroenterologists.
The cardiopulmonary effects of mask wearing
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.
There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.
But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.
But, as the poet said, all that is less than 2.5 microns in size is not coronavirus. Wildfire smoke is also chock full of fine particulate matter. And so, N95s are having something of a comeback.
That’s why an article that took a deep look at what happens to our cardiovascular system when we wear N95 masks caught my eye.
Mask wearing has been the subject of intense debate around the country. While the vast majority of evidence, as well as the personal experience of thousands of doctors, suggests that wearing a mask has no significant physiologic effects, it’s not hard to find those who suggest that mask wearing depletes oxygen levels, or leads to infection, or has other bizarre effects.
In a world of conflicting opinions, a controlled study is a wonderful thing, and that’s what appeared in JAMA Network Open.
This isn’t a huge study, but it’s big enough to make some important conclusions. Thirty individuals, all young and healthy, half female, were enrolled. Each participant spent 3 days in a metabolic chamber; this is essentially a giant, airtight room where all the inputs (oxygen levels and so on) and outputs (carbon dioxide levels and so on) can be precisely measured.
After a day of getting used to the environment, the participants spent a day either wearing an N95 mask or not for 16 waking hours. On the next day, they switched. Every other variable was controlled, from the calories in their diet to the temperature of the room itself.
They engaged in light exercise twice during the day – riding a stationary bike – and a host of physiologic parameters were measured. The question being, would the wearing of the mask for 16 hours straight change anything?
And the answer is yes, some things changed, but not by much.
Here’s a graph of the heart rate over time. You can see some separation, with higher heart rates during the mask-wearing day, particularly around 11 a.m. – when light exercise was scheduled.
Zooming in on the exercise period makes the difference more clear. The heart rate was about eight beats/min higher while masked and engaging in exercise. Systolic blood pressure was about 6 mm Hg higher. Oxygen saturation was lower by 0.7%.
So yes, exercising while wearing an N95 mask might be different from exercising without an N95 mask. But nothing here looks dangerous to me. The 0.7% decrease in oxygen saturation is smaller than the typical measurement error of a pulse oximeter. The authors write that venous pH decreased during the masked day, which is of more interest to me as a nephrologist, but they don’t show that data even in the supplement. I suspect it didn’t decrease much.
They also showed that respiratory rate during exercise decreased in the masked condition. That doesn’t really make sense when you think about it in the context of the other findings, which are all suggestive of increased metabolic rate and sympathetic drive. Does that call the whole procedure into question? No, but it’s worth noting.
These were young, healthy people. You could certainly argue that those with more vulnerable cardiopulmonary status might have had different effects from mask wearing, but without a specific study in those people, it’s just conjecture. Clearly, this study lets us conclude that mask wearing at rest has less of an effect than mask wearing during exercise.
But remember that, in reality, we are wearing masks for a reason. One could imagine a study where this metabolic chamber was filled with wildfire smoke at a concentration similar to what we saw in New York. In that situation, we might find that wearing an N95 is quite helpful. The thing is, studying masks in isolation is useful because you can control so many variables. But masks aren’t used in isolation. In fact, that’s sort of their defining characteristic.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.
There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.
But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.
But, as the poet said, all that is less than 2.5 microns in size is not coronavirus. Wildfire smoke is also chock full of fine particulate matter. And so, N95s are having something of a comeback.
That’s why an article that took a deep look at what happens to our cardiovascular system when we wear N95 masks caught my eye.
Mask wearing has been the subject of intense debate around the country. While the vast majority of evidence, as well as the personal experience of thousands of doctors, suggests that wearing a mask has no significant physiologic effects, it’s not hard to find those who suggest that mask wearing depletes oxygen levels, or leads to infection, or has other bizarre effects.
In a world of conflicting opinions, a controlled study is a wonderful thing, and that’s what appeared in JAMA Network Open.
This isn’t a huge study, but it’s big enough to make some important conclusions. Thirty individuals, all young and healthy, half female, were enrolled. Each participant spent 3 days in a metabolic chamber; this is essentially a giant, airtight room where all the inputs (oxygen levels and so on) and outputs (carbon dioxide levels and so on) can be precisely measured.
After a day of getting used to the environment, the participants spent a day either wearing an N95 mask or not for 16 waking hours. On the next day, they switched. Every other variable was controlled, from the calories in their diet to the temperature of the room itself.
They engaged in light exercise twice during the day – riding a stationary bike – and a host of physiologic parameters were measured. The question being, would the wearing of the mask for 16 hours straight change anything?
And the answer is yes, some things changed, but not by much.
Here’s a graph of the heart rate over time. You can see some separation, with higher heart rates during the mask-wearing day, particularly around 11 a.m. – when light exercise was scheduled.
Zooming in on the exercise period makes the difference more clear. The heart rate was about eight beats/min higher while masked and engaging in exercise. Systolic blood pressure was about 6 mm Hg higher. Oxygen saturation was lower by 0.7%.
So yes, exercising while wearing an N95 mask might be different from exercising without an N95 mask. But nothing here looks dangerous to me. The 0.7% decrease in oxygen saturation is smaller than the typical measurement error of a pulse oximeter. The authors write that venous pH decreased during the masked day, which is of more interest to me as a nephrologist, but they don’t show that data even in the supplement. I suspect it didn’t decrease much.
They also showed that respiratory rate during exercise decreased in the masked condition. That doesn’t really make sense when you think about it in the context of the other findings, which are all suggestive of increased metabolic rate and sympathetic drive. Does that call the whole procedure into question? No, but it’s worth noting.
These were young, healthy people. You could certainly argue that those with more vulnerable cardiopulmonary status might have had different effects from mask wearing, but without a specific study in those people, it’s just conjecture. Clearly, this study lets us conclude that mask wearing at rest has less of an effect than mask wearing during exercise.
But remember that, in reality, we are wearing masks for a reason. One could imagine a study where this metabolic chamber was filled with wildfire smoke at a concentration similar to what we saw in New York. In that situation, we might find that wearing an N95 is quite helpful. The thing is, studying masks in isolation is useful because you can control so many variables. But masks aren’t used in isolation. In fact, that’s sort of their defining characteristic.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.
There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.
But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.
But, as the poet said, all that is less than 2.5 microns in size is not coronavirus. Wildfire smoke is also chock full of fine particulate matter. And so, N95s are having something of a comeback.
That’s why an article that took a deep look at what happens to our cardiovascular system when we wear N95 masks caught my eye.
Mask wearing has been the subject of intense debate around the country. While the vast majority of evidence, as well as the personal experience of thousands of doctors, suggests that wearing a mask has no significant physiologic effects, it’s not hard to find those who suggest that mask wearing depletes oxygen levels, or leads to infection, or has other bizarre effects.
In a world of conflicting opinions, a controlled study is a wonderful thing, and that’s what appeared in JAMA Network Open.
This isn’t a huge study, but it’s big enough to make some important conclusions. Thirty individuals, all young and healthy, half female, were enrolled. Each participant spent 3 days in a metabolic chamber; this is essentially a giant, airtight room where all the inputs (oxygen levels and so on) and outputs (carbon dioxide levels and so on) can be precisely measured.
After a day of getting used to the environment, the participants spent a day either wearing an N95 mask or not for 16 waking hours. On the next day, they switched. Every other variable was controlled, from the calories in their diet to the temperature of the room itself.
They engaged in light exercise twice during the day – riding a stationary bike – and a host of physiologic parameters were measured. The question being, would the wearing of the mask for 16 hours straight change anything?
And the answer is yes, some things changed, but not by much.
Here’s a graph of the heart rate over time. You can see some separation, with higher heart rates during the mask-wearing day, particularly around 11 a.m. – when light exercise was scheduled.
Zooming in on the exercise period makes the difference more clear. The heart rate was about eight beats/min higher while masked and engaging in exercise. Systolic blood pressure was about 6 mm Hg higher. Oxygen saturation was lower by 0.7%.
So yes, exercising while wearing an N95 mask might be different from exercising without an N95 mask. But nothing here looks dangerous to me. The 0.7% decrease in oxygen saturation is smaller than the typical measurement error of a pulse oximeter. The authors write that venous pH decreased during the masked day, which is of more interest to me as a nephrologist, but they don’t show that data even in the supplement. I suspect it didn’t decrease much.
They also showed that respiratory rate during exercise decreased in the masked condition. That doesn’t really make sense when you think about it in the context of the other findings, which are all suggestive of increased metabolic rate and sympathetic drive. Does that call the whole procedure into question? No, but it’s worth noting.
These were young, healthy people. You could certainly argue that those with more vulnerable cardiopulmonary status might have had different effects from mask wearing, but without a specific study in those people, it’s just conjecture. Clearly, this study lets us conclude that mask wearing at rest has less of an effect than mask wearing during exercise.
But remember that, in reality, we are wearing masks for a reason. One could imagine a study where this metabolic chamber was filled with wildfire smoke at a concentration similar to what we saw in New York. In that situation, we might find that wearing an N95 is quite helpful. The thing is, studying masks in isolation is useful because you can control so many variables. But masks aren’t used in isolation. In fact, that’s sort of their defining characteristic.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Good COP, bad COP. Is this cardiorespiratory measure the best predictor of early death?
according to clinicians who champion the assessment. The COP is easier to obtain than cardiorespiratory measures that require people to exercise to their limit, advocates say; rather than running full speed, someone can walk or lightly jog on a treadmill, with a COP value obtained easily.
But other clinicians argue that maximal exercise tests have many prognostic benefits, and that physicians should do everything in their power to push patients to exercise as hard as possible. In particular, the VO2 max test captures the maximum amount of oxygen someone uses when exercising at their capacity and is the preferred method for measuring cardiovascular endurance.
The COP is a measure of the minimum number of liters of air during breathing required to move one liter of oxygen through the bloodstream. The lower the COP the better, because this means that someone is working less strenuously than someone else to transport the same amount of oxygen, denoting a more efficient interaction between their heart and lungs.
The COP for a fit person might be 15, about 20-25 for a healthy person, and 35 for someone with heart failure, according to Claudio Gil Araújo, MD, PhD, director of research and education at CLINIMEX, an exercise medicine clinic in Rio de Janeiro.
“Max VO2 is very important, that’s indisputable. But when do you use max VO2 in your daily life? Never,” Dr. Araújo said. But almost anyone can generate a COP.
Emerging uses for the COP
“I can put someone on the treadmill or bike, and after 3 or 4 minutes I have the COP. It’s like a walking pace,” Dr. Araújo said. Yet the values are obtained with roughly half the effort as VO2 max. Other clinicians argue exercising to the limits of endurance offers unique clinical insights.
“We should do everything in our power to exercise our patients to maximum. How long a patient is able to go is really important,” said Anu Lala, MD, a cardiologist who specializes in heart failure treatment at Mount Sinai Hospital in New York. A full-capacity exercise test gives useful insights into someone’s heart rate, heart rate recovery, blood pressure, and ECG response to vigorous exercise, Dr. Lala added, all of which are important clues to someone’s overall health.
In 2012 Dr. Araújo coauthored a study that first defined the COP, which is calculated by measuring expired gasses people produce while gently exercising, perhaps to the point where they begin to perspire, and then dividing their breathing capacity by their oxygen uptake every minute. The lowest value obtained during any exercise session is the COP.
Various studies show that higher COP values are associated with more severe heart lesions in patients with congenital heart disease; higher levels of mortality in seemingly healthy male adults; and with worse prognoses in patients with heart failure. These studies all appeared within the last 7 months.
The mortality study, which Dr. Araújo coauthored, compared COP in more than 3,000 U.S. men and women who completed an exercise test from 1973 to 2018 and were tracked for an average of 23 years. Although COP was introduced as an assessment in 2012, calculating the value from tests prior to that date was possible because those tests had captured the relevant breathing rate and oxygen uptake. In males aged 18-85 years, a worse COP was significantly associated with an increased risk for earlier death. This finding did not hold for females, however; Dr. Araújo noted that more research is needed to understand the discrepancy in COP’s predictive power by sex.
In the heart failure study, everyone enrolled had heart failure and completed a COP test. People with the worse COPs also had the worst symptoms of heart failure, but completing an exercise rehabilitation program improved COP values when researchers measured them again. Dr. Araújo was also part of this study, based in the Netherlands.
“I think the COP could become a novel parameter in clinical care,” for most people, said Thijs Eijsvogels, PhD, an exercise physiologist at Radboud University in Nijmegen, the Netherlands, and the senior author of the heart failure study. That said, Dr. Eijsvogels said elite athletes will always be more interested in measuring VO2 max.
Dr. Lala agreed that tests such as the COP have some value. Her own work has shown that measuring the efficiency of someone’s breathing patterns for exhaling carbon dioxide, which can also be done without making people exercise full strength, has prognostic value for patients with advanced heart failure. Even so, she said she would like to see maximal effort tests used as much as possible.
“I worry about saying we’re going to settle for a parameter that can be achieved at 50% of peak VO2 and then we don’t exercise our patients,” Dr. Lala said.
Dr. Araújo said he plans to continue to measure VO2 max but he believes COP has utility – even for elite athletes. One of his patients is a frequent Ironman competitor who competes well despite having a solid but not amazing VO2 max level. But her COP is quite low, Dr. Araújo said, which to him suggests an especially efficient interaction between her respiratory and cardiovascular systems.
“We have a new player in the game,” Dr. Araújo said.
The sources in this study report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to clinicians who champion the assessment. The COP is easier to obtain than cardiorespiratory measures that require people to exercise to their limit, advocates say; rather than running full speed, someone can walk or lightly jog on a treadmill, with a COP value obtained easily.
But other clinicians argue that maximal exercise tests have many prognostic benefits, and that physicians should do everything in their power to push patients to exercise as hard as possible. In particular, the VO2 max test captures the maximum amount of oxygen someone uses when exercising at their capacity and is the preferred method for measuring cardiovascular endurance.
The COP is a measure of the minimum number of liters of air during breathing required to move one liter of oxygen through the bloodstream. The lower the COP the better, because this means that someone is working less strenuously than someone else to transport the same amount of oxygen, denoting a more efficient interaction between their heart and lungs.
The COP for a fit person might be 15, about 20-25 for a healthy person, and 35 for someone with heart failure, according to Claudio Gil Araújo, MD, PhD, director of research and education at CLINIMEX, an exercise medicine clinic in Rio de Janeiro.
“Max VO2 is very important, that’s indisputable. But when do you use max VO2 in your daily life? Never,” Dr. Araújo said. But almost anyone can generate a COP.
Emerging uses for the COP
“I can put someone on the treadmill or bike, and after 3 or 4 minutes I have the COP. It’s like a walking pace,” Dr. Araújo said. Yet the values are obtained with roughly half the effort as VO2 max. Other clinicians argue exercising to the limits of endurance offers unique clinical insights.
“We should do everything in our power to exercise our patients to maximum. How long a patient is able to go is really important,” said Anu Lala, MD, a cardiologist who specializes in heart failure treatment at Mount Sinai Hospital in New York. A full-capacity exercise test gives useful insights into someone’s heart rate, heart rate recovery, blood pressure, and ECG response to vigorous exercise, Dr. Lala added, all of which are important clues to someone’s overall health.
In 2012 Dr. Araújo coauthored a study that first defined the COP, which is calculated by measuring expired gasses people produce while gently exercising, perhaps to the point where they begin to perspire, and then dividing their breathing capacity by their oxygen uptake every minute. The lowest value obtained during any exercise session is the COP.
Various studies show that higher COP values are associated with more severe heart lesions in patients with congenital heart disease; higher levels of mortality in seemingly healthy male adults; and with worse prognoses in patients with heart failure. These studies all appeared within the last 7 months.
The mortality study, which Dr. Araújo coauthored, compared COP in more than 3,000 U.S. men and women who completed an exercise test from 1973 to 2018 and were tracked for an average of 23 years. Although COP was introduced as an assessment in 2012, calculating the value from tests prior to that date was possible because those tests had captured the relevant breathing rate and oxygen uptake. In males aged 18-85 years, a worse COP was significantly associated with an increased risk for earlier death. This finding did not hold for females, however; Dr. Araújo noted that more research is needed to understand the discrepancy in COP’s predictive power by sex.
In the heart failure study, everyone enrolled had heart failure and completed a COP test. People with the worse COPs also had the worst symptoms of heart failure, but completing an exercise rehabilitation program improved COP values when researchers measured them again. Dr. Araújo was also part of this study, based in the Netherlands.
“I think the COP could become a novel parameter in clinical care,” for most people, said Thijs Eijsvogels, PhD, an exercise physiologist at Radboud University in Nijmegen, the Netherlands, and the senior author of the heart failure study. That said, Dr. Eijsvogels said elite athletes will always be more interested in measuring VO2 max.
Dr. Lala agreed that tests such as the COP have some value. Her own work has shown that measuring the efficiency of someone’s breathing patterns for exhaling carbon dioxide, which can also be done without making people exercise full strength, has prognostic value for patients with advanced heart failure. Even so, she said she would like to see maximal effort tests used as much as possible.
“I worry about saying we’re going to settle for a parameter that can be achieved at 50% of peak VO2 and then we don’t exercise our patients,” Dr. Lala said.
Dr. Araújo said he plans to continue to measure VO2 max but he believes COP has utility – even for elite athletes. One of his patients is a frequent Ironman competitor who competes well despite having a solid but not amazing VO2 max level. But her COP is quite low, Dr. Araújo said, which to him suggests an especially efficient interaction between her respiratory and cardiovascular systems.
“We have a new player in the game,” Dr. Araújo said.
The sources in this study report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to clinicians who champion the assessment. The COP is easier to obtain than cardiorespiratory measures that require people to exercise to their limit, advocates say; rather than running full speed, someone can walk or lightly jog on a treadmill, with a COP value obtained easily.
But other clinicians argue that maximal exercise tests have many prognostic benefits, and that physicians should do everything in their power to push patients to exercise as hard as possible. In particular, the VO2 max test captures the maximum amount of oxygen someone uses when exercising at their capacity and is the preferred method for measuring cardiovascular endurance.
The COP is a measure of the minimum number of liters of air during breathing required to move one liter of oxygen through the bloodstream. The lower the COP the better, because this means that someone is working less strenuously than someone else to transport the same amount of oxygen, denoting a more efficient interaction between their heart and lungs.
The COP for a fit person might be 15, about 20-25 for a healthy person, and 35 for someone with heart failure, according to Claudio Gil Araújo, MD, PhD, director of research and education at CLINIMEX, an exercise medicine clinic in Rio de Janeiro.
“Max VO2 is very important, that’s indisputable. But when do you use max VO2 in your daily life? Never,” Dr. Araújo said. But almost anyone can generate a COP.
Emerging uses for the COP
“I can put someone on the treadmill or bike, and after 3 or 4 minutes I have the COP. It’s like a walking pace,” Dr. Araújo said. Yet the values are obtained with roughly half the effort as VO2 max. Other clinicians argue exercising to the limits of endurance offers unique clinical insights.
“We should do everything in our power to exercise our patients to maximum. How long a patient is able to go is really important,” said Anu Lala, MD, a cardiologist who specializes in heart failure treatment at Mount Sinai Hospital in New York. A full-capacity exercise test gives useful insights into someone’s heart rate, heart rate recovery, blood pressure, and ECG response to vigorous exercise, Dr. Lala added, all of which are important clues to someone’s overall health.
In 2012 Dr. Araújo coauthored a study that first defined the COP, which is calculated by measuring expired gasses people produce while gently exercising, perhaps to the point where they begin to perspire, and then dividing their breathing capacity by their oxygen uptake every minute. The lowest value obtained during any exercise session is the COP.
Various studies show that higher COP values are associated with more severe heart lesions in patients with congenital heart disease; higher levels of mortality in seemingly healthy male adults; and with worse prognoses in patients with heart failure. These studies all appeared within the last 7 months.
The mortality study, which Dr. Araújo coauthored, compared COP in more than 3,000 U.S. men and women who completed an exercise test from 1973 to 2018 and were tracked for an average of 23 years. Although COP was introduced as an assessment in 2012, calculating the value from tests prior to that date was possible because those tests had captured the relevant breathing rate and oxygen uptake. In males aged 18-85 years, a worse COP was significantly associated with an increased risk for earlier death. This finding did not hold for females, however; Dr. Araújo noted that more research is needed to understand the discrepancy in COP’s predictive power by sex.
In the heart failure study, everyone enrolled had heart failure and completed a COP test. People with the worse COPs also had the worst symptoms of heart failure, but completing an exercise rehabilitation program improved COP values when researchers measured them again. Dr. Araújo was also part of this study, based in the Netherlands.
“I think the COP could become a novel parameter in clinical care,” for most people, said Thijs Eijsvogels, PhD, an exercise physiologist at Radboud University in Nijmegen, the Netherlands, and the senior author of the heart failure study. That said, Dr. Eijsvogels said elite athletes will always be more interested in measuring VO2 max.
Dr. Lala agreed that tests such as the COP have some value. Her own work has shown that measuring the efficiency of someone’s breathing patterns for exhaling carbon dioxide, which can also be done without making people exercise full strength, has prognostic value for patients with advanced heart failure. Even so, she said she would like to see maximal effort tests used as much as possible.
“I worry about saying we’re going to settle for a parameter that can be achieved at 50% of peak VO2 and then we don’t exercise our patients,” Dr. Lala said.
Dr. Araújo said he plans to continue to measure VO2 max but he believes COP has utility – even for elite athletes. One of his patients is a frequent Ironman competitor who competes well despite having a solid but not amazing VO2 max level. But her COP is quite low, Dr. Araújo said, which to him suggests an especially efficient interaction between her respiratory and cardiovascular systems.
“We have a new player in the game,” Dr. Araújo said.
The sources in this study report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-dose oral minoxidil for hair loss soars after NYT article
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
.
The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.
The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.
Rodney Sinclair, MD, professor of dermatology at the University of Melbourne, who conducted the original research on LDOM and hair loss and was quoted in the Times story, told this news organization that “the sharp uplift after the New York Times article was on the back of a gradual increase.” He added that “the momentum for minoxidil prescriptions is increasing,” so much so that it has led to a global shortage of LDOM. The drug appears to still be widely available in the United States, however. It is not on the ASHP shortages list.
“There has been growing momentum for minoxidil use since I first presented our data about 6 years ago,” Dr. Sinclair said. He noted that 2022 International Society of Hair Restoration Surgery survey data found that 26% of treating physicians always or often prescribed off-label oral minoxidil, up from 10% in 2019 and 0% in 2017, while another 20% said they prescribed it sometimes.
The authors of the new study looked at prescriptions for patients at eight health care systems before and after the Times article was published in August 2022. They calculated the rate of first-time oral minoxidil prescriptions for 2.5 mg and 5 mg tablets, excluding 10 mg tablets, which are prescribed for hypertension.
Among those receiving first-time prescriptions, 2,846 received them in the 7 months before the article and 3,695 in the 5 months after publication. Men (43.6% after vs. 37.7% before publication) and White individuals (68.6% after vs. 60.8% before publication) accounted for a higher proportion of prescriptions after the article was published. There was a 2.4-fold increase in first-time prescriptions among men, and a 1.7-fold increase among females, while people with comorbidities accounted for a smaller proportion after the publication.
“Socioeconomic factors, such as access to health care and education and income levels, may be associated with individuals seeking low-dose oral minoxidil after article publication,” wrote the authors.
In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.
He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.
The results are expected to published soon in the Journal of Drugs in Dermatology.
“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.
That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.
“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”
However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.
Both he and Dr. Sinclair expect demand for LDOM to continue increasing.
“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.
Dr. Sinclair and Dr. Friedman report no relevant financial relationships.
FROM JAMA NETWORK OPEN
Increase in message volume begs the question: ‘Should we be compensated for our time?’
The American Gastroenterological Association and other gastrointestinal-specific organizations have excellent resources available to members that focus on optimizing reimbursement in your clinical and endoscopic practice.
During the COVID-19 pandemic and public health emergency (PHE), many previously noncovered services were now covered under rules of the Centers for Medicare & Medicaid Services. During the pandemic, patient portal messages increased by 157%, meaning more work for health care teams, negatively impacting physician satisfaction, and increasing burnout.1 Medical burnout has been associated with increased time spent on electronic health records, with some subspeciality gastroenterology (GI) groups having a high EHR burden, according to a recently published article in the American Journal of Gastroenterology.2
This topic is a timely discussion as several large health systems have implemented processes to bill for non–face-to-face services (termed “asynchronous care”), some of which have not been well received in the lay media. It is important to note that despite these implementations, studies have shown only 1% of all incoming portal messages would meet criteria to be submitted for reimbursement. This impact might be slightly higher in chronic care management practices.
Providers and practices have several options when considering billing for non–face-to-face encounters, which we outline in Table 1.3
The focus of this article will be to review the more common non–face-to-face evaluation and management services, such as telephone E/M (patient phone call) and e-visits (patient portal messages) as these have recently generated the most interest and discussion amongst health care providers.
Telemedicine after COVID-19 pandemic
During the beginning of the pandemic, a web-based survey study found that almost all providers in GI practices implemented some form of telemedicine to continue to provide care for patients, compared to 32% prior to the pandemic.4,5 The high demand and essential requirement for telehealth evaluation facilitated its reimbursement, eliminating the primary barrier to previous use.6
One of the new covered benefits by CMS was asynchronous telehealth care.7 The PHE ended in May 2023, and since then a qualified health care provider (QHCP) does not have the full flexibility to deliver telemedicine services across state lines. The U.S. Department of Health and Human Services has considered some telehealth policy changes after the COVID-19 PHE and many of those will be extended, at least through 2024.8 As during the pandemic, where the U.S. national payer network (CMS, state Medicaid, and private payers) and state health agencies assisted to ensure patients get the care they need by authorizing providers to be compensated for non–face-to-face services, we believe this service will continue to be part of our clinical practice.
We recommend you stay informed about local and federal laws, regulations, and alternatives for reimbursement as they may be modified at the beginning of a new calendar year. Remember, you can always talk with your revenue cycle team to clarify any query.
Telephone evaluation and management services
The patient requests to speak with you.
Telephone evaluation and management services became more widely used after the pandemic and were recognized by CMS as a covered medical service under PHE. As outlined in Table 1, there are associated codes with this service and it can only apply to an established patient in your practice. The cumulative time spent over a 7-day period without generating an immediate follow-up visit could qualify for this CPT code. However, for a patient with a high-complexity diagnosis and/or decisions being made about care, it might be better to consider a virtual office visit as this would value the complex care at a higher level than the time spent during the telephone E/M encounter.
A common question comes up: Can my nurse or support team bill for telephone care? No, only QHCP can, which means physicians and advanced practice providers can bill for this E/M service, and it does not include time spent by other members of clinical staff in patient care. However, there are CPT codes for chronic care management, which is not covered in this article.
Virtual evaluation and management services
You respond to a patient-initiated portal message.
Patient portal messages increased exponentially during the pandemic with 2.5 more minutes spent per message, resulting in more EHR work by practitioners, compared with prior to the pandemic. One study showed an immediate postpandemic increase in EHR patient-initiated messages with no return to prepandemic baseline.1
Although studies evaluating postpandemic telemedicine services are needed, we believe that this trend will continue, and for this reason, it is important to create sustainable workflows to continue to provide this patient driven avenue of care.9
E-visits are asynchronous patient or guardian portal messages that require a minimum of 5 minutes to provide medical decision-making without prior E/M services in the last 7 days. To obtain reimbursement for this service, it cannot be initiated by the provider, and patient consent must be obtained. Documentation should include this information and the time spent in the encounter. The associated CPT codes with this e-service are outlined in Table 1.
A common question is, “Are there additional codes I should use if a portal message E/M visit lasts more than 30 minutes?” No. If an e-visit lasts more than 30 minutes, the QHCP should bill the CPT code 99423. However, we would advise that, if this care requires more than 30 minutes, then either virtual or face-to-face E/M be considered for the optimal reimbursement for provider time spent. Another common question is around consent for services, and we advise providers to review this requirement with their compliance colleagues as each institution has different policies.
Virtual check-in
Medicare also covers brief communication technology–based services also known as virtual check-ins, where patients can communicate with their provider after having established care. During this brief conversation that can be via telephone, audio/video, secure text messaging, email, or patient portal, providers will determine if an in-person visit is necessary. CMS has designed G codes for these virtual check-ins that are from the Healthcare Common Procedure Coding System (HCPCS). Two codes are available for this E/M service: G2012, which is outlined in Table 1, and G2010, which covers the evaluation of images and/or recorded videos. In order to be reimbursed for a G2010 code, providers need at least a 5-minute response to make a clinical determination or give the patient a medical impression.
Patient satisfaction, physician well-being and quality of care outcomes
Large health care systems like Kaiser Permanente implemented secure message patient-physician communication (the patient portal) even before the pandemic, showing promising results in 2010 with reduction in office visits, improvement in measurable quality outcomes, and high level of patient satisfaction.10 Post pandemic, several large health care centers opted to announce the billing implementation for patient-initiated portal messages.11 A focus was placed on educating their patients about when a message will and will not be billed. Using this type of strategy can help to improve patient awareness about potential billing without affecting patient satisfaction and care outcomes. Studies have shown the EHR has contributed to physician burnout and some physicians reducing their clinical time or leaving medicine; a reduction in messaging might have a positive impact on physician well-being.
The challenge is that medical billing is not routinely included as a curriculum topic in many residency and fellowship programs; however, trainees are part of E/M services and have limited knowledge of billing processes. Unfortunately, at this time, trainees cannot submit for reimbursement for asynchronous care as described above. We hope that this brief article will help junior gastroenterologists optimize their outpatient billing practices.
Dr. Nieto is an internal medicine chief resident with WellStar Cobb Medical Center, Austell, Ga. Dr. Kinnucan is a gastroenterologist with Mayo Clinic, Jacksonville, Fla. The authors have no conflicts of interest to disclose for this article. The authors certify that no financial and grant support has been received for this article.
References
1. Holmgren AJ et al. J Am Med Inform Assoc. 2021 Dec 9. doi: 10.1093/jamia/ocab268.
2. Bali AS et al. Am J Gastroenterol. 2023 Apr 24. doi: 10.14309/ajg.0000000000002254.
3. AAFP. Family Physician. “Coding Scenario: Coding for Virtual-Digital Visits”
4. Keihanian T. et al. Telehealth Utilization in Gastroenterology Clinics Amid the COVID-19 Pandemic: Impact on Clinical Practice and Gastroenterology Training. Gastroenterology. 2020 Jun 20. doi: 10.1053/j.gastro.2020.06.040.
5. Lewin S et al. J Crohns Colitis. 2020 Oct 21. doi: 10.1093/ecco-jcc/jjaa140.
6. Perisetti A and H Goyal. Dig Dis Sci. 2021 Mar 3. doi: 10.1007/s10620-021-06874-x.
7. Telehealth.HHS.gov. Medicaid and Medicare billing for asynchronous telehealth. Updated: 2022 May 4.
8. Telehealth.HHS.gov. Telehealth policy changes after the COVID-19 public health emergency. Last updated: 2023 Jan 23.
9. Fox B and Sizemore JO. Telehealth: Fad or the future. Epic Health Research Network. 2020 Aug 18.
10. Baer D. Patient-physician e-mail communication: the kaiser permanente experience. J Oncol Pract. 2011 Jul. doi: 10.1200/JOP.2011.000323.
11. Myclevelandclinic.org. MyChart Messaging.
12. Sinsky CA et al. J Gen Intern Med. 2022 Aug 29. doi: 10.1007/s11606-022-07766-0.
The American Gastroenterological Association and other gastrointestinal-specific organizations have excellent resources available to members that focus on optimizing reimbursement in your clinical and endoscopic practice.
During the COVID-19 pandemic and public health emergency (PHE), many previously noncovered services were now covered under rules of the Centers for Medicare & Medicaid Services. During the pandemic, patient portal messages increased by 157%, meaning more work for health care teams, negatively impacting physician satisfaction, and increasing burnout.1 Medical burnout has been associated with increased time spent on electronic health records, with some subspeciality gastroenterology (GI) groups having a high EHR burden, according to a recently published article in the American Journal of Gastroenterology.2
This topic is a timely discussion as several large health systems have implemented processes to bill for non–face-to-face services (termed “asynchronous care”), some of which have not been well received in the lay media. It is important to note that despite these implementations, studies have shown only 1% of all incoming portal messages would meet criteria to be submitted for reimbursement. This impact might be slightly higher in chronic care management practices.
Providers and practices have several options when considering billing for non–face-to-face encounters, which we outline in Table 1.3
The focus of this article will be to review the more common non–face-to-face evaluation and management services, such as telephone E/M (patient phone call) and e-visits (patient portal messages) as these have recently generated the most interest and discussion amongst health care providers.
Telemedicine after COVID-19 pandemic
During the beginning of the pandemic, a web-based survey study found that almost all providers in GI practices implemented some form of telemedicine to continue to provide care for patients, compared to 32% prior to the pandemic.4,5 The high demand and essential requirement for telehealth evaluation facilitated its reimbursement, eliminating the primary barrier to previous use.6
One of the new covered benefits by CMS was asynchronous telehealth care.7 The PHE ended in May 2023, and since then a qualified health care provider (QHCP) does not have the full flexibility to deliver telemedicine services across state lines. The U.S. Department of Health and Human Services has considered some telehealth policy changes after the COVID-19 PHE and many of those will be extended, at least through 2024.8 As during the pandemic, where the U.S. national payer network (CMS, state Medicaid, and private payers) and state health agencies assisted to ensure patients get the care they need by authorizing providers to be compensated for non–face-to-face services, we believe this service will continue to be part of our clinical practice.
We recommend you stay informed about local and federal laws, regulations, and alternatives for reimbursement as they may be modified at the beginning of a new calendar year. Remember, you can always talk with your revenue cycle team to clarify any query.
Telephone evaluation and management services
The patient requests to speak with you.
Telephone evaluation and management services became more widely used after the pandemic and were recognized by CMS as a covered medical service under PHE. As outlined in Table 1, there are associated codes with this service and it can only apply to an established patient in your practice. The cumulative time spent over a 7-day period without generating an immediate follow-up visit could qualify for this CPT code. However, for a patient with a high-complexity diagnosis and/or decisions being made about care, it might be better to consider a virtual office visit as this would value the complex care at a higher level than the time spent during the telephone E/M encounter.
A common question comes up: Can my nurse or support team bill for telephone care? No, only QHCP can, which means physicians and advanced practice providers can bill for this E/M service, and it does not include time spent by other members of clinical staff in patient care. However, there are CPT codes for chronic care management, which is not covered in this article.
Virtual evaluation and management services
You respond to a patient-initiated portal message.
Patient portal messages increased exponentially during the pandemic with 2.5 more minutes spent per message, resulting in more EHR work by practitioners, compared with prior to the pandemic. One study showed an immediate postpandemic increase in EHR patient-initiated messages with no return to prepandemic baseline.1
Although studies evaluating postpandemic telemedicine services are needed, we believe that this trend will continue, and for this reason, it is important to create sustainable workflows to continue to provide this patient driven avenue of care.9
E-visits are asynchronous patient or guardian portal messages that require a minimum of 5 minutes to provide medical decision-making without prior E/M services in the last 7 days. To obtain reimbursement for this service, it cannot be initiated by the provider, and patient consent must be obtained. Documentation should include this information and the time spent in the encounter. The associated CPT codes with this e-service are outlined in Table 1.
A common question is, “Are there additional codes I should use if a portal message E/M visit lasts more than 30 minutes?” No. If an e-visit lasts more than 30 minutes, the QHCP should bill the CPT code 99423. However, we would advise that, if this care requires more than 30 minutes, then either virtual or face-to-face E/M be considered for the optimal reimbursement for provider time spent. Another common question is around consent for services, and we advise providers to review this requirement with their compliance colleagues as each institution has different policies.
Virtual check-in
Medicare also covers brief communication technology–based services also known as virtual check-ins, where patients can communicate with their provider after having established care. During this brief conversation that can be via telephone, audio/video, secure text messaging, email, or patient portal, providers will determine if an in-person visit is necessary. CMS has designed G codes for these virtual check-ins that are from the Healthcare Common Procedure Coding System (HCPCS). Two codes are available for this E/M service: G2012, which is outlined in Table 1, and G2010, which covers the evaluation of images and/or recorded videos. In order to be reimbursed for a G2010 code, providers need at least a 5-minute response to make a clinical determination or give the patient a medical impression.
Patient satisfaction, physician well-being and quality of care outcomes
Large health care systems like Kaiser Permanente implemented secure message patient-physician communication (the patient portal) even before the pandemic, showing promising results in 2010 with reduction in office visits, improvement in measurable quality outcomes, and high level of patient satisfaction.10 Post pandemic, several large health care centers opted to announce the billing implementation for patient-initiated portal messages.11 A focus was placed on educating their patients about when a message will and will not be billed. Using this type of strategy can help to improve patient awareness about potential billing without affecting patient satisfaction and care outcomes. Studies have shown the EHR has contributed to physician burnout and some physicians reducing their clinical time or leaving medicine; a reduction in messaging might have a positive impact on physician well-being.
The challenge is that medical billing is not routinely included as a curriculum topic in many residency and fellowship programs; however, trainees are part of E/M services and have limited knowledge of billing processes. Unfortunately, at this time, trainees cannot submit for reimbursement for asynchronous care as described above. We hope that this brief article will help junior gastroenterologists optimize their outpatient billing practices.
Dr. Nieto is an internal medicine chief resident with WellStar Cobb Medical Center, Austell, Ga. Dr. Kinnucan is a gastroenterologist with Mayo Clinic, Jacksonville, Fla. The authors have no conflicts of interest to disclose for this article. The authors certify that no financial and grant support has been received for this article.
References
1. Holmgren AJ et al. J Am Med Inform Assoc. 2021 Dec 9. doi: 10.1093/jamia/ocab268.
2. Bali AS et al. Am J Gastroenterol. 2023 Apr 24. doi: 10.14309/ajg.0000000000002254.
3. AAFP. Family Physician. “Coding Scenario: Coding for Virtual-Digital Visits”
4. Keihanian T. et al. Telehealth Utilization in Gastroenterology Clinics Amid the COVID-19 Pandemic: Impact on Clinical Practice and Gastroenterology Training. Gastroenterology. 2020 Jun 20. doi: 10.1053/j.gastro.2020.06.040.
5. Lewin S et al. J Crohns Colitis. 2020 Oct 21. doi: 10.1093/ecco-jcc/jjaa140.
6. Perisetti A and H Goyal. Dig Dis Sci. 2021 Mar 3. doi: 10.1007/s10620-021-06874-x.
7. Telehealth.HHS.gov. Medicaid and Medicare billing for asynchronous telehealth. Updated: 2022 May 4.
8. Telehealth.HHS.gov. Telehealth policy changes after the COVID-19 public health emergency. Last updated: 2023 Jan 23.
9. Fox B and Sizemore JO. Telehealth: Fad or the future. Epic Health Research Network. 2020 Aug 18.
10. Baer D. Patient-physician e-mail communication: the kaiser permanente experience. J Oncol Pract. 2011 Jul. doi: 10.1200/JOP.2011.000323.
11. Myclevelandclinic.org. MyChart Messaging.
12. Sinsky CA et al. J Gen Intern Med. 2022 Aug 29. doi: 10.1007/s11606-022-07766-0.
The American Gastroenterological Association and other gastrointestinal-specific organizations have excellent resources available to members that focus on optimizing reimbursement in your clinical and endoscopic practice.
During the COVID-19 pandemic and public health emergency (PHE), many previously noncovered services were now covered under rules of the Centers for Medicare & Medicaid Services. During the pandemic, patient portal messages increased by 157%, meaning more work for health care teams, negatively impacting physician satisfaction, and increasing burnout.1 Medical burnout has been associated with increased time spent on electronic health records, with some subspeciality gastroenterology (GI) groups having a high EHR burden, according to a recently published article in the American Journal of Gastroenterology.2
This topic is a timely discussion as several large health systems have implemented processes to bill for non–face-to-face services (termed “asynchronous care”), some of which have not been well received in the lay media. It is important to note that despite these implementations, studies have shown only 1% of all incoming portal messages would meet criteria to be submitted for reimbursement. This impact might be slightly higher in chronic care management practices.
Providers and practices have several options when considering billing for non–face-to-face encounters, which we outline in Table 1.3
The focus of this article will be to review the more common non–face-to-face evaluation and management services, such as telephone E/M (patient phone call) and e-visits (patient portal messages) as these have recently generated the most interest and discussion amongst health care providers.
Telemedicine after COVID-19 pandemic
During the beginning of the pandemic, a web-based survey study found that almost all providers in GI practices implemented some form of telemedicine to continue to provide care for patients, compared to 32% prior to the pandemic.4,5 The high demand and essential requirement for telehealth evaluation facilitated its reimbursement, eliminating the primary barrier to previous use.6
One of the new covered benefits by CMS was asynchronous telehealth care.7 The PHE ended in May 2023, and since then a qualified health care provider (QHCP) does not have the full flexibility to deliver telemedicine services across state lines. The U.S. Department of Health and Human Services has considered some telehealth policy changes after the COVID-19 PHE and many of those will be extended, at least through 2024.8 As during the pandemic, where the U.S. national payer network (CMS, state Medicaid, and private payers) and state health agencies assisted to ensure patients get the care they need by authorizing providers to be compensated for non–face-to-face services, we believe this service will continue to be part of our clinical practice.
We recommend you stay informed about local and federal laws, regulations, and alternatives for reimbursement as they may be modified at the beginning of a new calendar year. Remember, you can always talk with your revenue cycle team to clarify any query.
Telephone evaluation and management services
The patient requests to speak with you.
Telephone evaluation and management services became more widely used after the pandemic and were recognized by CMS as a covered medical service under PHE. As outlined in Table 1, there are associated codes with this service and it can only apply to an established patient in your practice. The cumulative time spent over a 7-day period without generating an immediate follow-up visit could qualify for this CPT code. However, for a patient with a high-complexity diagnosis and/or decisions being made about care, it might be better to consider a virtual office visit as this would value the complex care at a higher level than the time spent during the telephone E/M encounter.
A common question comes up: Can my nurse or support team bill for telephone care? No, only QHCP can, which means physicians and advanced practice providers can bill for this E/M service, and it does not include time spent by other members of clinical staff in patient care. However, there are CPT codes for chronic care management, which is not covered in this article.
Virtual evaluation and management services
You respond to a patient-initiated portal message.
Patient portal messages increased exponentially during the pandemic with 2.5 more minutes spent per message, resulting in more EHR work by practitioners, compared with prior to the pandemic. One study showed an immediate postpandemic increase in EHR patient-initiated messages with no return to prepandemic baseline.1
Although studies evaluating postpandemic telemedicine services are needed, we believe that this trend will continue, and for this reason, it is important to create sustainable workflows to continue to provide this patient driven avenue of care.9
E-visits are asynchronous patient or guardian portal messages that require a minimum of 5 minutes to provide medical decision-making without prior E/M services in the last 7 days. To obtain reimbursement for this service, it cannot be initiated by the provider, and patient consent must be obtained. Documentation should include this information and the time spent in the encounter. The associated CPT codes with this e-service are outlined in Table 1.
A common question is, “Are there additional codes I should use if a portal message E/M visit lasts more than 30 minutes?” No. If an e-visit lasts more than 30 minutes, the QHCP should bill the CPT code 99423. However, we would advise that, if this care requires more than 30 minutes, then either virtual or face-to-face E/M be considered for the optimal reimbursement for provider time spent. Another common question is around consent for services, and we advise providers to review this requirement with their compliance colleagues as each institution has different policies.
Virtual check-in
Medicare also covers brief communication technology–based services also known as virtual check-ins, where patients can communicate with their provider after having established care. During this brief conversation that can be via telephone, audio/video, secure text messaging, email, or patient portal, providers will determine if an in-person visit is necessary. CMS has designed G codes for these virtual check-ins that are from the Healthcare Common Procedure Coding System (HCPCS). Two codes are available for this E/M service: G2012, which is outlined in Table 1, and G2010, which covers the evaluation of images and/or recorded videos. In order to be reimbursed for a G2010 code, providers need at least a 5-minute response to make a clinical determination or give the patient a medical impression.
Patient satisfaction, physician well-being and quality of care outcomes
Large health care systems like Kaiser Permanente implemented secure message patient-physician communication (the patient portal) even before the pandemic, showing promising results in 2010 with reduction in office visits, improvement in measurable quality outcomes, and high level of patient satisfaction.10 Post pandemic, several large health care centers opted to announce the billing implementation for patient-initiated portal messages.11 A focus was placed on educating their patients about when a message will and will not be billed. Using this type of strategy can help to improve patient awareness about potential billing without affecting patient satisfaction and care outcomes. Studies have shown the EHR has contributed to physician burnout and some physicians reducing their clinical time or leaving medicine; a reduction in messaging might have a positive impact on physician well-being.
The challenge is that medical billing is not routinely included as a curriculum topic in many residency and fellowship programs; however, trainees are part of E/M services and have limited knowledge of billing processes. Unfortunately, at this time, trainees cannot submit for reimbursement for asynchronous care as described above. We hope that this brief article will help junior gastroenterologists optimize their outpatient billing practices.
Dr. Nieto is an internal medicine chief resident with WellStar Cobb Medical Center, Austell, Ga. Dr. Kinnucan is a gastroenterologist with Mayo Clinic, Jacksonville, Fla. The authors have no conflicts of interest to disclose for this article. The authors certify that no financial and grant support has been received for this article.
References
1. Holmgren AJ et al. J Am Med Inform Assoc. 2021 Dec 9. doi: 10.1093/jamia/ocab268.
2. Bali AS et al. Am J Gastroenterol. 2023 Apr 24. doi: 10.14309/ajg.0000000000002254.
3. AAFP. Family Physician. “Coding Scenario: Coding for Virtual-Digital Visits”
4. Keihanian T. et al. Telehealth Utilization in Gastroenterology Clinics Amid the COVID-19 Pandemic: Impact on Clinical Practice and Gastroenterology Training. Gastroenterology. 2020 Jun 20. doi: 10.1053/j.gastro.2020.06.040.
5. Lewin S et al. J Crohns Colitis. 2020 Oct 21. doi: 10.1093/ecco-jcc/jjaa140.
6. Perisetti A and H Goyal. Dig Dis Sci. 2021 Mar 3. doi: 10.1007/s10620-021-06874-x.
7. Telehealth.HHS.gov. Medicaid and Medicare billing for asynchronous telehealth. Updated: 2022 May 4.
8. Telehealth.HHS.gov. Telehealth policy changes after the COVID-19 public health emergency. Last updated: 2023 Jan 23.
9. Fox B and Sizemore JO. Telehealth: Fad or the future. Epic Health Research Network. 2020 Aug 18.
10. Baer D. Patient-physician e-mail communication: the kaiser permanente experience. J Oncol Pract. 2011 Jul. doi: 10.1200/JOP.2011.000323.
11. Myclevelandclinic.org. MyChart Messaging.
12. Sinsky CA et al. J Gen Intern Med. 2022 Aug 29. doi: 10.1007/s11606-022-07766-0.
Applications of ChatGPT and Large Language Models in Medicine and Health Care: Benefits and Pitfalls
The development of [artificial intelligence] is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other.
Bill Gates 1
As the world emerges from the pandemic and the health care system faces new challenges, technology has become an increasingly important tool for health care professionals (HCPs). One such technology is the large language model (LLM), which has the potential to revolutionize the health care industry. ChatGPT, a popular LLM developed by OpenAI, has gained particular attention in the medical community for its ability to pass the United States Medical Licensing Exam.2 This article will explore the benefits and potential pitfalls of using LLMs like ChatGPT in medicine and health care.
Benefits
HCP burnout is a serious issue that can lead to lower productivity, increased medical errors, and decreased patient satisfaction.3 LLMs can alleviate some administrative burdens on HCPs, allowing them to focus on patient care. By assisting with billing, coding, insurance claims, and organizing schedules, LLMs like ChatGPT can free up time for HCPs to focus on what they do best: providing quality patient care.4 ChatGPT also can assist with diagnoses by providing accurate and reliable information based on a vast amount of clinical data. By learning the relationships between different medical conditions, symptoms, and treatment options, ChatGPT can provide an appropriate differential diagnosis (Figure 1). 
Imaging medical specialists like radiologists, pathologists, dermatologists, and others can benefit from combining computer vision diagnostics with ChatGPT report creation abilities to streamline the diagnostic workflow and improve diagnostic accuracy (Figure 2). 
Although using ChatGPT and other LLMs in mental health care has potential benefits, it is essential to note that they are not a substitute for human interaction and personalized care. While ChatGPT can remember information from previous conversations, it cannot provide the same level of personalized, high-quality care that a professional therapist or HCP can. However, by augmenting the work of HCPs, ChatGPT and other LLMs have the potential to make mental health care more accessible and efficient. In addition to providing effective screening in underserved areas, ChatGPT technology may improve the competence of physician assistants and nurse practitioners in delivering mental health care. With the increased incidence of mental health problems in veterans, the pertinence of a ChatGPT-like feature will only increase with time.9
ChatGPT can also be integrated into health care organizations’ websites and mobile apps, providing patients instant access to medical information, self-care advice, symptom checkers, scheduling appointments, and arranging transportation. These features can reduce the burden on health care staff and help patients stay informed and motivated to take an active role in their health. Additionally, health care organizations can use ChatGPT to engage patients by providing reminders for medication renewals and assistance with self-care.4,6,10,11
The potential of artificial intelligence (AI) in the field of medical education and research is immense. According to a study by Gilson and colleagues, ChatGPT has shown promising results as a medical education tool.12 ChatGPT can simulate clinical scenarios, provide real-time feedback, and improve diagnostic skills. It also offers new interactive and personalized learning opportunities for medical students and HCPs.13 ChatGPT can help researchers by streamlining the process of data analysis. It can also administer surveys or questionnaires, facilitate data collection on preferences and experiences, and help in writing scientific publications.14 Nevertheless, to fully unlock the potential of these AI models, additional models that perform checks for factual accuracy, plagiarism, and copyright infringement must be developed.15,16
AI Bill of Rights
In order to protect the American public, the White House Office of Science and Technology Policy (OSTP) has released a blueprint for an AI Bill of Rights that emphasizes 5 principles to protect the public from the harmful effects of AI models, including safe and effective systems; algorithmic discrimination protection; data privacy; notice and explanation; and human alternatives, considerations, and fallback (Figure 3).17 
One of the biggest challenges with LLMs like ChatGPT is the prevalence of inaccurate information or so-called hallucinations.16 These inaccuracies stem from the inability of LLMs to distinguish between real and fake information. To prevent hallucinations, researchers have proposed several methods, including training models on more diverse data, using adversarial training methods, and human-in-the-loop approaches.21 In addition, medicine-specific models like GatorTron, medPaLM, and Almanac were developed, increasing the accuracy of factual results.22-24 Unfortunately, only the GatorTron model is available to the public through the NVIDIA developers’ program.25
Despite these shortcomings, the future of LLMs in health care is promising. Although these models will not replace HCPs, they can help reduce the unnecessary burden on them, prevent burnout, and enable HCPs and patients spend more time together. Establishing an official hospital AI oversight governing body that would promote best practices could ensure the trustworthy implementation of these new technologies.26
Conclusions
The use of ChatGPT and other LLMs in health care has the potential to revolutionize the industry. By assisting HCPs with administrative tasks, improving the accuracy and reliability of diagnoses, and engaging patients, ChatGPT can help health care organizations provide better care to their patients. While LLMs are not a substitute for human interaction and personalized care, they can augment the work of HCPs, making health care more accessible and efficient. As the health care industry continues to evolve, it will be exciting to see how ChatGPT and other LLMs are used to improve patient outcomes and quality of care. In addition, AI technologies like ChatGPT offer enormous potential in medical education and research. To ensure that the benefits outweigh the risks, developing trustworthy AI health care products and establishing oversight governing bodies to ensure their implementation is essential. By doing so, we can help HCPs focus on what matters most, providing high-quality care to patients.
Acknowledgments
This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.
1. Bill Gates. The age of AI has begun. March 21, 2023. Accessed May 10, 2023. https://www.gatesnotes.com/the-age-of-ai-has-begun
2. Kung TH, Cheatham M, Medenilla A, et al. Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models. PLOS Digit Health. 2023;2(2):e0000198. Published 2023 Feb 9. doi:10.1371/journal.pdig.0000198
3. Shanafelt TD, West CP, Sinsky C, et al. Changes in burnout and satisfaction with work-life integration in physicians and the general US working population between 2011 and 2020. Mayo Clin Proc. 2022;97(3):491-506. doi:10.1016/j.mayocp.2021.11.021
4. Goodman RS, Patrinely JR Jr, Osterman T, Wheless L, Johnson DB. On the cusp: considering the impact of artificial intelligence language models in healthcare. Med. 2023;4(3):139-140. doi:10.1016/j.medj.2023.02.008
5. Will ChatGPT transform healthcare? Nat Med. 2023;29(3):505-506. doi:10.1038/s41591-023-02289-5
6. Hopkins AM, Logan JM, Kichenadasse G, Sorich MJ. Artificial intelligence chatbots will revolutionize how cancer patients access information: ChatGPT represents a paradigm-shift. JNCI Cancer Spectr. 2023;7(2):pkad010. doi:10.1093/jncics/pkad010
7. Babar Z, van Laarhoven T, Zanzotto FM, Marchiori E. Evaluating diagnostic content of AI-generated radiology reports of chest X-rays. Artif Intell Med. 2021;116:102075. doi:10.1016/j.artmed.2021.102075
8. Lecler A, Duron L, Soyer P. Revolutionizing radiology with GPT-based models: current applications, future possibilities and limitations of ChatGPT. Diagn Interv Imaging. 2023;S2211-5684(23)00027-X. doi:10.1016/j.diii.2023.02.003
9. Germain JM. Is ChatGPT smart enough to practice mental health therapy? March 23, 2023. Accessed May 11, 2023. https://www.technewsworld.com/story/is-chatgpt-smart-enough-to-practice-mental-health-therapy-178064.html
10. Cascella M, Montomoli J, Bellini V, Bignami E. Evaluating the feasibility of ChatGPT in healthcare: an analysis of multiple clinical and research scenarios. J Med Syst. 2023;47(1):33. Published 2023 Mar 4. doi:10.1007/s10916-023-01925-4
11. Jungwirth D, Haluza D. Artificial intelligence and public health: an exploratory study. Int J Environ Res Public Health. 2023;20(5):4541. Published 2023 Mar 3. doi:10.3390/ijerph20054541
12. Gilson A, Safranek CW, Huang T, et al. How does ChatGPT perform on the United States Medical Licensing Examination? The implications of large language models for medical education and knowledge assessment. JMIR Med Educ. 2023;9:e45312. Published 2023 Feb 8. doi:10.2196/45312
13. Eysenbach G. The role of ChatGPT, generative language models, and artificial intelligence in medical education: a conversation with ChatGPT and a call for papers. JMIR Med Educ. 2023;9:e46885. Published 2023 Mar 6. doi:10.2196/46885
14. Macdonald C, Adeloye D, Sheikh A, Rudan I. Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis. J Glob Health. 2023;13:01003. Published 2023 Feb 17. doi:10.7189/jogh.13.01003
15. Masters K. Ethical use of artificial intelligence in health professions education: AMEE Guide No.158. Med Teach. 2023;1-11. doi:10.1080/0142159X.2023.2186203
16. Smith CS. Hallucinations could blunt ChatGPT’s success. IEEE Spectrum. March 13, 2023. Accessed May 11, 2023. https://spectrum.ieee.org/ai-hallucination
17. Executive Office of the President, Office of Science and Technology Policy. Blueprint for an AI Bill of Rights. Accessed May 11, 2023. https://www.whitehouse.gov/ostp/ai-bill-of-rights
18. Executive office of the President. Executive Order 13960: promoting the use of trustworthy artificial intelligence in the federal government. Fed Regist. 2020;89(236):78939-78943.
19. US Department of Commerce, National institute of Standards and Technology. Artificial Intelligence Risk Management Framework (AI RMF 1.0). Published January 2023. doi:10.6028/NIST.AI.100-1
20. Microsoft. Azure Cognitive Search—Cloud Search Service. Accessed May 11, 2023. https://azure.microsoft.com/en-us/products/search
21. Aiyappa R, An J, Kwak H, Ahn YY. Can we trust the evaluation on ChatGPT? March 22, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.12767v1
22. Yang X, Chen A, Pournejatian N, et al. GatorTron: a large clinical language model to unlock patient information from unstructured electronic health records. Updated December 16, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2203.03540v3
23. Singhal K, Azizi S, Tu T, et al. Large language models encode clinical knowledge. December 26, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2212.13138v1
24. Zakka C, Chaurasia A, Shad R, Hiesinger W. Almanac: knowledge-grounded language models for clinical medicine. March 1, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.01229v1
25. NVIDIA. GatorTron-OG. Accessed May 11, 2023. https://catalog.ngc.nvidia.com/orgs/nvidia/teams/clara/models/gatortron_og
26. Borkowski AA, Jakey CE, Thomas LB, Viswanadhan N, Mastorides SM. Establishing a hospital artificial intelligence committee to improve patient care. Fed Pract. 2022;39(8):334-336. doi:10.12788/fp.0299
The development of [artificial intelligence] is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other.
Bill Gates 1
As the world emerges from the pandemic and the health care system faces new challenges, technology has become an increasingly important tool for health care professionals (HCPs). One such technology is the large language model (LLM), which has the potential to revolutionize the health care industry. ChatGPT, a popular LLM developed by OpenAI, has gained particular attention in the medical community for its ability to pass the United States Medical Licensing Exam.2 This article will explore the benefits and potential pitfalls of using LLMs like ChatGPT in medicine and health care.
Benefits
HCP burnout is a serious issue that can lead to lower productivity, increased medical errors, and decreased patient satisfaction.3 LLMs can alleviate some administrative burdens on HCPs, allowing them to focus on patient care. By assisting with billing, coding, insurance claims, and organizing schedules, LLMs like ChatGPT can free up time for HCPs to focus on what they do best: providing quality patient care.4 ChatGPT also can assist with diagnoses by providing accurate and reliable information based on a vast amount of clinical data. By learning the relationships between different medical conditions, symptoms, and treatment options, ChatGPT can provide an appropriate differential diagnosis (Figure 1).
Imaging medical specialists like radiologists, pathologists, dermatologists, and others can benefit from combining computer vision diagnostics with ChatGPT report creation abilities to streamline the diagnostic workflow and improve diagnostic accuracy (Figure 2).
Although using ChatGPT and other LLMs in mental health care has potential benefits, it is essential to note that they are not a substitute for human interaction and personalized care. While ChatGPT can remember information from previous conversations, it cannot provide the same level of personalized, high-quality care that a professional therapist or HCP can. However, by augmenting the work of HCPs, ChatGPT and other LLMs have the potential to make mental health care more accessible and efficient. In addition to providing effective screening in underserved areas, ChatGPT technology may improve the competence of physician assistants and nurse practitioners in delivering mental health care. With the increased incidence of mental health problems in veterans, the pertinence of a ChatGPT-like feature will only increase with time.9
ChatGPT can also be integrated into health care organizations’ websites and mobile apps, providing patients instant access to medical information, self-care advice, symptom checkers, scheduling appointments, and arranging transportation. These features can reduce the burden on health care staff and help patients stay informed and motivated to take an active role in their health. Additionally, health care organizations can use ChatGPT to engage patients by providing reminders for medication renewals and assistance with self-care.4,6,10,11
The potential of artificial intelligence (AI) in the field of medical education and research is immense. According to a study by Gilson and colleagues, ChatGPT has shown promising results as a medical education tool.12 ChatGPT can simulate clinical scenarios, provide real-time feedback, and improve diagnostic skills. It also offers new interactive and personalized learning opportunities for medical students and HCPs.13 ChatGPT can help researchers by streamlining the process of data analysis. It can also administer surveys or questionnaires, facilitate data collection on preferences and experiences, and help in writing scientific publications.14 Nevertheless, to fully unlock the potential of these AI models, additional models that perform checks for factual accuracy, plagiarism, and copyright infringement must be developed.15,16
AI Bill of Rights
In order to protect the American public, the White House Office of Science and Technology Policy (OSTP) has released a blueprint for an AI Bill of Rights that emphasizes 5 principles to protect the public from the harmful effects of AI models, including safe and effective systems; algorithmic discrimination protection; data privacy; notice and explanation; and human alternatives, considerations, and fallback (Figure 3).17
One of the biggest challenges with LLMs like ChatGPT is the prevalence of inaccurate information or so-called hallucinations.16 These inaccuracies stem from the inability of LLMs to distinguish between real and fake information. To prevent hallucinations, researchers have proposed several methods, including training models on more diverse data, using adversarial training methods, and human-in-the-loop approaches.21 In addition, medicine-specific models like GatorTron, medPaLM, and Almanac were developed, increasing the accuracy of factual results.22-24 Unfortunately, only the GatorTron model is available to the public through the NVIDIA developers’ program.25
Despite these shortcomings, the future of LLMs in health care is promising. Although these models will not replace HCPs, they can help reduce the unnecessary burden on them, prevent burnout, and enable HCPs and patients spend more time together. Establishing an official hospital AI oversight governing body that would promote best practices could ensure the trustworthy implementation of these new technologies.26
Conclusions
The use of ChatGPT and other LLMs in health care has the potential to revolutionize the industry. By assisting HCPs with administrative tasks, improving the accuracy and reliability of diagnoses, and engaging patients, ChatGPT can help health care organizations provide better care to their patients. While LLMs are not a substitute for human interaction and personalized care, they can augment the work of HCPs, making health care more accessible and efficient. As the health care industry continues to evolve, it will be exciting to see how ChatGPT and other LLMs are used to improve patient outcomes and quality of care. In addition, AI technologies like ChatGPT offer enormous potential in medical education and research. To ensure that the benefits outweigh the risks, developing trustworthy AI health care products and establishing oversight governing bodies to ensure their implementation is essential. By doing so, we can help HCPs focus on what matters most, providing high-quality care to patients.
Acknowledgments
This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.
The development of [artificial intelligence] is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other.
Bill Gates 1
As the world emerges from the pandemic and the health care system faces new challenges, technology has become an increasingly important tool for health care professionals (HCPs). One such technology is the large language model (LLM), which has the potential to revolutionize the health care industry. ChatGPT, a popular LLM developed by OpenAI, has gained particular attention in the medical community for its ability to pass the United States Medical Licensing Exam.2 This article will explore the benefits and potential pitfalls of using LLMs like ChatGPT in medicine and health care.
Benefits
HCP burnout is a serious issue that can lead to lower productivity, increased medical errors, and decreased patient satisfaction.3 LLMs can alleviate some administrative burdens on HCPs, allowing them to focus on patient care. By assisting with billing, coding, insurance claims, and organizing schedules, LLMs like ChatGPT can free up time for HCPs to focus on what they do best: providing quality patient care.4 ChatGPT also can assist with diagnoses by providing accurate and reliable information based on a vast amount of clinical data. By learning the relationships between different medical conditions, symptoms, and treatment options, ChatGPT can provide an appropriate differential diagnosis (Figure 1).
Imaging medical specialists like radiologists, pathologists, dermatologists, and others can benefit from combining computer vision diagnostics with ChatGPT report creation abilities to streamline the diagnostic workflow and improve diagnostic accuracy (Figure 2).
Although using ChatGPT and other LLMs in mental health care has potential benefits, it is essential to note that they are not a substitute for human interaction and personalized care. While ChatGPT can remember information from previous conversations, it cannot provide the same level of personalized, high-quality care that a professional therapist or HCP can. However, by augmenting the work of HCPs, ChatGPT and other LLMs have the potential to make mental health care more accessible and efficient. In addition to providing effective screening in underserved areas, ChatGPT technology may improve the competence of physician assistants and nurse practitioners in delivering mental health care. With the increased incidence of mental health problems in veterans, the pertinence of a ChatGPT-like feature will only increase with time.9
ChatGPT can also be integrated into health care organizations’ websites and mobile apps, providing patients instant access to medical information, self-care advice, symptom checkers, scheduling appointments, and arranging transportation. These features can reduce the burden on health care staff and help patients stay informed and motivated to take an active role in their health. Additionally, health care organizations can use ChatGPT to engage patients by providing reminders for medication renewals and assistance with self-care.4,6,10,11
The potential of artificial intelligence (AI) in the field of medical education and research is immense. According to a study by Gilson and colleagues, ChatGPT has shown promising results as a medical education tool.12 ChatGPT can simulate clinical scenarios, provide real-time feedback, and improve diagnostic skills. It also offers new interactive and personalized learning opportunities for medical students and HCPs.13 ChatGPT can help researchers by streamlining the process of data analysis. It can also administer surveys or questionnaires, facilitate data collection on preferences and experiences, and help in writing scientific publications.14 Nevertheless, to fully unlock the potential of these AI models, additional models that perform checks for factual accuracy, plagiarism, and copyright infringement must be developed.15,16
AI Bill of Rights
In order to protect the American public, the White House Office of Science and Technology Policy (OSTP) has released a blueprint for an AI Bill of Rights that emphasizes 5 principles to protect the public from the harmful effects of AI models, including safe and effective systems; algorithmic discrimination protection; data privacy; notice and explanation; and human alternatives, considerations, and fallback (Figure 3).17
One of the biggest challenges with LLMs like ChatGPT is the prevalence of inaccurate information or so-called hallucinations.16 These inaccuracies stem from the inability of LLMs to distinguish between real and fake information. To prevent hallucinations, researchers have proposed several methods, including training models on more diverse data, using adversarial training methods, and human-in-the-loop approaches.21 In addition, medicine-specific models like GatorTron, medPaLM, and Almanac were developed, increasing the accuracy of factual results.22-24 Unfortunately, only the GatorTron model is available to the public through the NVIDIA developers’ program.25
Despite these shortcomings, the future of LLMs in health care is promising. Although these models will not replace HCPs, they can help reduce the unnecessary burden on them, prevent burnout, and enable HCPs and patients spend more time together. Establishing an official hospital AI oversight governing body that would promote best practices could ensure the trustworthy implementation of these new technologies.26
Conclusions
The use of ChatGPT and other LLMs in health care has the potential to revolutionize the industry. By assisting HCPs with administrative tasks, improving the accuracy and reliability of diagnoses, and engaging patients, ChatGPT can help health care organizations provide better care to their patients. While LLMs are not a substitute for human interaction and personalized care, they can augment the work of HCPs, making health care more accessible and efficient. As the health care industry continues to evolve, it will be exciting to see how ChatGPT and other LLMs are used to improve patient outcomes and quality of care. In addition, AI technologies like ChatGPT offer enormous potential in medical education and research. To ensure that the benefits outweigh the risks, developing trustworthy AI health care products and establishing oversight governing bodies to ensure their implementation is essential. By doing so, we can help HCPs focus on what matters most, providing high-quality care to patients.
Acknowledgments
This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.
1. Bill Gates. The age of AI has begun. March 21, 2023. Accessed May 10, 2023. https://www.gatesnotes.com/the-age-of-ai-has-begun
2. Kung TH, Cheatham M, Medenilla A, et al. Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models. PLOS Digit Health. 2023;2(2):e0000198. Published 2023 Feb 9. doi:10.1371/journal.pdig.0000198
3. Shanafelt TD, West CP, Sinsky C, et al. Changes in burnout and satisfaction with work-life integration in physicians and the general US working population between 2011 and 2020. Mayo Clin Proc. 2022;97(3):491-506. doi:10.1016/j.mayocp.2021.11.021
4. Goodman RS, Patrinely JR Jr, Osterman T, Wheless L, Johnson DB. On the cusp: considering the impact of artificial intelligence language models in healthcare. Med. 2023;4(3):139-140. doi:10.1016/j.medj.2023.02.008
5. Will ChatGPT transform healthcare? Nat Med. 2023;29(3):505-506. doi:10.1038/s41591-023-02289-5
6. Hopkins AM, Logan JM, Kichenadasse G, Sorich MJ. Artificial intelligence chatbots will revolutionize how cancer patients access information: ChatGPT represents a paradigm-shift. JNCI Cancer Spectr. 2023;7(2):pkad010. doi:10.1093/jncics/pkad010
7. Babar Z, van Laarhoven T, Zanzotto FM, Marchiori E. Evaluating diagnostic content of AI-generated radiology reports of chest X-rays. Artif Intell Med. 2021;116:102075. doi:10.1016/j.artmed.2021.102075
8. Lecler A, Duron L, Soyer P. Revolutionizing radiology with GPT-based models: current applications, future possibilities and limitations of ChatGPT. Diagn Interv Imaging. 2023;S2211-5684(23)00027-X. doi:10.1016/j.diii.2023.02.003
9. Germain JM. Is ChatGPT smart enough to practice mental health therapy? March 23, 2023. Accessed May 11, 2023. https://www.technewsworld.com/story/is-chatgpt-smart-enough-to-practice-mental-health-therapy-178064.html
10. Cascella M, Montomoli J, Bellini V, Bignami E. Evaluating the feasibility of ChatGPT in healthcare: an analysis of multiple clinical and research scenarios. J Med Syst. 2023;47(1):33. Published 2023 Mar 4. doi:10.1007/s10916-023-01925-4
11. Jungwirth D, Haluza D. Artificial intelligence and public health: an exploratory study. Int J Environ Res Public Health. 2023;20(5):4541. Published 2023 Mar 3. doi:10.3390/ijerph20054541
12. Gilson A, Safranek CW, Huang T, et al. How does ChatGPT perform on the United States Medical Licensing Examination? The implications of large language models for medical education and knowledge assessment. JMIR Med Educ. 2023;9:e45312. Published 2023 Feb 8. doi:10.2196/45312
13. Eysenbach G. The role of ChatGPT, generative language models, and artificial intelligence in medical education: a conversation with ChatGPT and a call for papers. JMIR Med Educ. 2023;9:e46885. Published 2023 Mar 6. doi:10.2196/46885
14. Macdonald C, Adeloye D, Sheikh A, Rudan I. Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis. J Glob Health. 2023;13:01003. Published 2023 Feb 17. doi:10.7189/jogh.13.01003
15. Masters K. Ethical use of artificial intelligence in health professions education: AMEE Guide No.158. Med Teach. 2023;1-11. doi:10.1080/0142159X.2023.2186203
16. Smith CS. Hallucinations could blunt ChatGPT’s success. IEEE Spectrum. March 13, 2023. Accessed May 11, 2023. https://spectrum.ieee.org/ai-hallucination
17. Executive Office of the President, Office of Science and Technology Policy. Blueprint for an AI Bill of Rights. Accessed May 11, 2023. https://www.whitehouse.gov/ostp/ai-bill-of-rights
18. Executive office of the President. Executive Order 13960: promoting the use of trustworthy artificial intelligence in the federal government. Fed Regist. 2020;89(236):78939-78943.
19. US Department of Commerce, National institute of Standards and Technology. Artificial Intelligence Risk Management Framework (AI RMF 1.0). Published January 2023. doi:10.6028/NIST.AI.100-1
20. Microsoft. Azure Cognitive Search—Cloud Search Service. Accessed May 11, 2023. https://azure.microsoft.com/en-us/products/search
21. Aiyappa R, An J, Kwak H, Ahn YY. Can we trust the evaluation on ChatGPT? March 22, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.12767v1
22. Yang X, Chen A, Pournejatian N, et al. GatorTron: a large clinical language model to unlock patient information from unstructured electronic health records. Updated December 16, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2203.03540v3
23. Singhal K, Azizi S, Tu T, et al. Large language models encode clinical knowledge. December 26, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2212.13138v1
24. Zakka C, Chaurasia A, Shad R, Hiesinger W. Almanac: knowledge-grounded language models for clinical medicine. March 1, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.01229v1
25. NVIDIA. GatorTron-OG. Accessed May 11, 2023. https://catalog.ngc.nvidia.com/orgs/nvidia/teams/clara/models/gatortron_og
26. Borkowski AA, Jakey CE, Thomas LB, Viswanadhan N, Mastorides SM. Establishing a hospital artificial intelligence committee to improve patient care. Fed Pract. 2022;39(8):334-336. doi:10.12788/fp.0299
1. Bill Gates. The age of AI has begun. March 21, 2023. Accessed May 10, 2023. https://www.gatesnotes.com/the-age-of-ai-has-begun
2. Kung TH, Cheatham M, Medenilla A, et al. Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models. PLOS Digit Health. 2023;2(2):e0000198. Published 2023 Feb 9. doi:10.1371/journal.pdig.0000198
3. Shanafelt TD, West CP, Sinsky C, et al. Changes in burnout and satisfaction with work-life integration in physicians and the general US working population between 2011 and 2020. Mayo Clin Proc. 2022;97(3):491-506. doi:10.1016/j.mayocp.2021.11.021
4. Goodman RS, Patrinely JR Jr, Osterman T, Wheless L, Johnson DB. On the cusp: considering the impact of artificial intelligence language models in healthcare. Med. 2023;4(3):139-140. doi:10.1016/j.medj.2023.02.008
5. Will ChatGPT transform healthcare? Nat Med. 2023;29(3):505-506. doi:10.1038/s41591-023-02289-5
6. Hopkins AM, Logan JM, Kichenadasse G, Sorich MJ. Artificial intelligence chatbots will revolutionize how cancer patients access information: ChatGPT represents a paradigm-shift. JNCI Cancer Spectr. 2023;7(2):pkad010. doi:10.1093/jncics/pkad010
7. Babar Z, van Laarhoven T, Zanzotto FM, Marchiori E. Evaluating diagnostic content of AI-generated radiology reports of chest X-rays. Artif Intell Med. 2021;116:102075. doi:10.1016/j.artmed.2021.102075
8. Lecler A, Duron L, Soyer P. Revolutionizing radiology with GPT-based models: current applications, future possibilities and limitations of ChatGPT. Diagn Interv Imaging. 2023;S2211-5684(23)00027-X. doi:10.1016/j.diii.2023.02.003
9. Germain JM. Is ChatGPT smart enough to practice mental health therapy? March 23, 2023. Accessed May 11, 2023. https://www.technewsworld.com/story/is-chatgpt-smart-enough-to-practice-mental-health-therapy-178064.html
10. Cascella M, Montomoli J, Bellini V, Bignami E. Evaluating the feasibility of ChatGPT in healthcare: an analysis of multiple clinical and research scenarios. J Med Syst. 2023;47(1):33. Published 2023 Mar 4. doi:10.1007/s10916-023-01925-4
11. Jungwirth D, Haluza D. Artificial intelligence and public health: an exploratory study. Int J Environ Res Public Health. 2023;20(5):4541. Published 2023 Mar 3. doi:10.3390/ijerph20054541
12. Gilson A, Safranek CW, Huang T, et al. How does ChatGPT perform on the United States Medical Licensing Examination? The implications of large language models for medical education and knowledge assessment. JMIR Med Educ. 2023;9:e45312. Published 2023 Feb 8. doi:10.2196/45312
13. Eysenbach G. The role of ChatGPT, generative language models, and artificial intelligence in medical education: a conversation with ChatGPT and a call for papers. JMIR Med Educ. 2023;9:e46885. Published 2023 Mar 6. doi:10.2196/46885
14. Macdonald C, Adeloye D, Sheikh A, Rudan I. Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis. J Glob Health. 2023;13:01003. Published 2023 Feb 17. doi:10.7189/jogh.13.01003
15. Masters K. Ethical use of artificial intelligence in health professions education: AMEE Guide No.158. Med Teach. 2023;1-11. doi:10.1080/0142159X.2023.2186203
16. Smith CS. Hallucinations could blunt ChatGPT’s success. IEEE Spectrum. March 13, 2023. Accessed May 11, 2023. https://spectrum.ieee.org/ai-hallucination
17. Executive Office of the President, Office of Science and Technology Policy. Blueprint for an AI Bill of Rights. Accessed May 11, 2023. https://www.whitehouse.gov/ostp/ai-bill-of-rights
18. Executive office of the President. Executive Order 13960: promoting the use of trustworthy artificial intelligence in the federal government. Fed Regist. 2020;89(236):78939-78943.
19. US Department of Commerce, National institute of Standards and Technology. Artificial Intelligence Risk Management Framework (AI RMF 1.0). Published January 2023. doi:10.6028/NIST.AI.100-1
20. Microsoft. Azure Cognitive Search—Cloud Search Service. Accessed May 11, 2023. https://azure.microsoft.com/en-us/products/search
21. Aiyappa R, An J, Kwak H, Ahn YY. Can we trust the evaluation on ChatGPT? March 22, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.12767v1
22. Yang X, Chen A, Pournejatian N, et al. GatorTron: a large clinical language model to unlock patient information from unstructured electronic health records. Updated December 16, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2203.03540v3
23. Singhal K, Azizi S, Tu T, et al. Large language models encode clinical knowledge. December 26, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2212.13138v1
24. Zakka C, Chaurasia A, Shad R, Hiesinger W. Almanac: knowledge-grounded language models for clinical medicine. March 1, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.01229v1
25. NVIDIA. GatorTron-OG. Accessed May 11, 2023. https://catalog.ngc.nvidia.com/orgs/nvidia/teams/clara/models/gatortron_og
26. Borkowski AA, Jakey CE, Thomas LB, Viswanadhan N, Mastorides SM. Establishing a hospital artificial intelligence committee to improve patient care. Fed Pract. 2022;39(8):334-336. doi:10.12788/fp.0299
WHO advises against nonsugar sweeteners for weight control
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
Impact of Pharmacist Interventions at an Outpatient US Coast Guard Clinic
The US Coast Guard (USCG) operates within the US Department of Homeland Security during times of peace and represents a force of > 55,000 active-duty service members (ADSMs), civilians, and reservists. ADSMs account for about 40,000 USCG personnel. The missions of the USCG include activities such as maritime law enforcement (drug interdiction), search and rescue, and defense readiness.1 Akin to other US Department of Defense (DoD) services, USCG ADSMs are required to maintain medical readiness to maximize operational success.
Whereas the DoD centralizes its health care services at military treatment facilities, USCG health care tends to be dispersed to smaller clinics and sickbays across large geographic areas. The USCG operates 42 clinics of varying sizes and medical capabilities, providing outpatient, dentistry, pharmacy, laboratory, radiology, physical therapy, optometry, and other health care services. Many ADSMs are evaluated by a USCG medical officer in these outpatient clinics, and ADSMs may choose to fill prescriptions at the in-house pharmacy if present at that clinic.
The USCG has 14 field pharmacists. In addition to the standard dispensing role at their respective clinics, USCG pharmacists provide regional oversight of pharmaceutical services for USCG units within their area of responsibility (AOR). Therefore, USCG pharmacists clinically, operationally, and logistically support these regional assets within their AOR while serving the traditional pharmacist role. USCG pharmacists have access to ADSM electronic health records (EHRs) when evaluating prescription orders, similar to other ambulatory care settings.
New recruits and accessions into the USCG are first screened for disqualifying health conditions, and ADSMs are required to maintain medical readiness throughout their careers.2 Therefore, this population tends to be younger and overall healthier compared with the general population. Equally important, medication errors or inappropriate prescribing in the ADSM group could negatively affect their duty status and mission readiness of the USCG in addition to exposing the ADSM to medication-related harms.
Duty status is an important and unique consideration in this population. ADSMs are expected to be deployable worldwide and physically and mentally capable of executing all duties associated with their position. Duty status implications and the perceived ability to stand watch are tied to an ADMS’s specialty, training, and unit role. Duty status is based on various frameworks like the USCG Medical Manual, Aeromedical Policy Letters, and other governing documents.3 Duty status determinations are initiated by privileged USCG medical practitioners and may be executed in consultation with relevant commands and other subject matter experts. An inappropriately dosed antibiotic prescription, for example, can extend the duration that an ADSM would be considered unfit for full duty due to prolonged illness. Accordingly, being on a limited duty status may negatively affect USCG total mission readiness as a whole. USCG pharmacists play a vital role in optimizing ADSMs’ medication therapies to ensure safety and efficacy.
Currently no published literature explores the number of medication interventions or the impact of those interventions made by USCG pharmacists. This study aimed to quantify the number, duty status impact, and replicability of medication interventions made by one pharmacist at the USCG Base Alameda clinic over 6 months.
Methods
As part of a USCG quality improvement study, a pharmacist tracked all medication interventions on a spreadsheet at USCG Base Alameda clinic from July 1, 2021, to December 31, 2021. The study defined a medication intervention as a communication with the prescriber with the intention to change the medication, strength, dose, dosage form, quantity, or instructions. Each intervention was subcategorized as either a drug therapy problem (DTP) or a non-DTP intervention. Interventions were divided into 7 categories.
Each DTP intervention was evaluated in a retrospective chart review by a panel of USCG pharmacists to assess for duty status severity and replicability. For duty status severity, the panel reviewed the intervention after considering patient-specific factors and determined whether the original prescribing (had there not been an intervention) could have reasonably resulted in a change of duty status for the ADSM from a fit for full duty (FFFD) status to a different duty status (eg, fit for limited duty [FFLD]). This duty status review factored in potential impacts across multiple positions and billets, including aviators (pilots) and divers. In addition, the panel, whose members all have prior community pharmacy experience, assessed replicability by determining whether the same intervention could have reasonably been made in the absence of access to the patient EHR, as would be common in a community pharmacy setting.
Interventions without an identified DTP were considered non-DTP interventions. These interventions involved recommendations for a more cost-effective medication or a similar in stock therapeutic option to minimize delay of patient care. The spreadsheet also included the date, medication name, medication class, specific intervention made, outcome, and other descriptive comments.
Results
During the 6-month period, 1751 prescriptions were dispensed at USCG Base Alameda pharmacy with 116 interventions (7%).
Among the DTP interventions, 26 (41%) dealt with an inappropriate dose, 13 (20%) were for medication omission, 7 (11%) for inappropriate dosage form, and 6 (9%) for excess medication (Table 2). 
Discussion
This study is novel in examining the impact of a pharmacist’s medication interventions in a USCG ambulatory care practice setting. A PubMed literature search of the phrases “Coast Guard AND pharmacy” or “Coast Guard AND pharmacy AND intervention” yielded no results specific to pharmacy interventions in a USCG setting. However, the 2021 implementation of the enterprise-wide MHS GENESIS EHR may support additional tracking and analysis tools in the future.
Pharmacist interventions have been studied in diverse patient populations and practice settings, and most conclude that pharmacists make meaningful interventions at their respective organizations.4-7 Many of these studies were conducted at open-door health care systems, whereas USCG clinics serve ADSMs nearly exclusively. The ADSM population tends to be younger and healthier due to age requirements and medical accession and retention standards.
It is important to recognize the value of a USCG pharmacist in identifying and rectifying potential medication errors, particularly those that may affect the ability to stand duty for ADSMs. An example intervention includes changing the daily starting dose of citalopram from the ordered 30 mg to the intended 10 mg. Inappropriately prescribed medication regimens may increase the incidence of adverse effects or prolong duration to therapeutic efficacy, which impairs the ability to stand duty. There were 3 circumstances where the prescriber had ordered the medication for an incorrect ADSM that were rectified by the pharmacist. If left unchanged, these errors could negatively affect the ADSM’s overall health, well-being, and duty status.
The acceptance rate for interventions in this study was 96%. The literature suggests a highly variable acceptance rate of pharmacist interventions when examined across various practice settings, health systems, and geographic locations.8-10 This study’s comparatively high rate could be due to the pharmacist-prescriber relationships at USCG clinics. By virtue of colocatation and teamwork initiatives, the pharmacist has the opportunity to develop positive rapport with physicians, physician assistants, and other clinic staff.
Having access to EHRs allowed the pharmacist to make 18 of the DTP interventions. Chart access is not unique to the USCG and is common in other ambulatory care settings. Those 18 interventions, such as reconciling a prescription ordered as fluticasone/salmeterol but recorded in the EHR as “will prescribe montelukast,” were deemed possible because of EHR access. Such interventions could potentially be lost if ADSMs solely received their pharmaceutical care elsewhere.
USCG uses independent duty health services technicians (IDHSs) who practice in settings where a medical officer is not present, such as at smaller sickbays or aboard Coast Guard cutters. In this study, an IDHS had mistakenly created a medication order for the medical officer to sign for bupropion SR, when the ADSM had been taking and was intended to continue taking bupropion XL. This order was signed off by the medical officer, but this oversight was identified and corrected by the pharmacist before dispensing. This indicates that there is a vital educational role that the USCG pharmacist fulfills when working with health care team members within the AOR.
Equally important to consider are the non-DTP interventions. In a military setting, minimizations of delay in care are a high priority. There were 34 instances where the pharmacist made an intervention to recommend a similar therapeutic medication that was in stock to ensure that the ADSM had timely access to the medication without the need for prior authorization. In the context of short-notice, mission-critical deployments that may last for multiple months, recognizing medication shortages or other inventory constraints and recommending therapeutic alternatives ensures that the USCG can maintain a ready posture for missions in addition to providing timely and quality patient care.
Saving about $1700 over 6 months is also important. While this was not explicitly evaluated in the study, prescribers may not be acutely aware of medication pricing. There are often significant price differences between different formulations of the same medication (eg, naproxen delayed-release vs tablets). Because USCG pharmacists are responsible for ordering medications and managing their regional budget within the AOR, they are best poised to make cost-savings recommendations. These interventions suggest that USCG pharmacists must continue to remain actively involved in the patient care team alongside physicians, physician assistants, nurses, and corpsmen. Throughout this setting and in so many others, patients’ health outcomes improve when pharmacists are more engaged in the pharmacotherapy care plan.
Limitations
Currently, the USCG does not publish ADSM demographic or health-related data, making it difficult to evaluate these interventions in the context of age, gender, or type of disease. Accordingly, potential directions for future research include how USCG pharmacists’ interventions are stratified by duty station and initial diagnosis. Such studies may support future models where USCG pharmacists are providing targeted education to prescribers based on disease or medication classes.
This analysis may have limited applicability to other practice settings even within USCG. Most USCG clinics have a limited number of medical officers; indeed, many have only one, and clinics with pharmacies typically have 1 to 5 medical officers aboard. USCG medical officers have a multitude of other duties, which may impact prescribing patterns and pharmacist interventions. Statistical analyses were limited by the dearth of baseline data or comparative literature. Finally, the assessment of DTP interventions’ impact did not use an official measurement tool like the US Department of Veterans Affairs’ Safety Assessment Code matrix.11 Instead, the study used the internal USCG pharmacist panel for the fitness for duty consideration as the main stratification of the DTP interventions’ duty status severity, because maintaining medical readiness is the top priority for a USCG clinic.
Conclusions
The multifaceted role of pharmacists in USCG clinics includes collaborating with the patient care team to make pharmacy interventions that have significant impacts on ADSMs’ wellness and the USCG mission. The ADSMs of this nation deserve quality medical care that translates into mission readiness, and the USCG pharmacy force stands ready to support that goal.
Acknowledgments
The authors acknowledge the contributions of CDR Christopher Janik, US Coast Guard Headquarters, and LCDR Darin Schneider, US Coast Guard D11 Regional Practice Manager, in the drafting of the manuscript.
1. US Coast Guard. Missions. Accessed May 4, 2023. https://www.uscg.mil/About/Missions
2. US Coast Guard. Coast Guard Medical Manual. Updated September 13, 2022. Accessed May 4, 2023. https://media.defense.gov/2022/Sep/14/2003076969/-1/-1/0/CIM_6000_1F.PDF
3. US Coast Guard. USCG Aeromedical Policy Letters. Accessed May 5, 2023. https://www.dcms.uscg.mil/Portals/10/CG-1/cg112/cg1121/docs/pdf/USCG_Aeromedical_Policy_Letters.pdf
4. Bedouch P, Sylvoz N, Charpiat B, et al. Trends in pharmacists’ medication order review in French hospitals from 2006 to 2009: analysis of pharmacists’ interventions from the Act-IP website observatory. J Clin Pharm Ther. 2015;40(1):32-40. doi:10.1111/jcpt.12214
5. Ooi PL, Zainal H, Lean QY, Ming LC, Ibrahim B. Pharmacists’ interventions on electronic prescriptions from various specialty wards in a Malaysian public hospital: a cross-sectional study. Pharmacy (Basel). 2021;9(4):161. Published 2021 Oct 1. doi:10.3390/pharmacy9040161
6. Alomi YA, El-Bahnasawi M, Kamran M, Shaweesh T, Alhaj S, Radwan RA. The clinical outcomes of pharmacist interventions at critical care services of private hospital in Riyadh City, Saudi Arabia. PTB Report. 2019;5(1):16-19. doi:10.5530/ptb.2019.5.4
7. Garin N, Sole N, Lucas B, et al. Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions. Sci Rep. 2021;11(1):883. Published 2021 Jan 13. doi:10.1038/s41598-020-80560-2
8. Zaal RJ, den Haak EW, Andrinopoulou ER, van Gelder T, Vulto AG, van den Bemt PMLA. Physicians’ acceptance of pharmacists’ interventions in daily hospital practice. Int J Clin Pharm. 2020;42(1):141-149. doi:10.1007/s11096-020-00970-0
9. Carson GL, Crosby K, Huxall GR, Brahm NC. Acceptance rates for pharmacist-initiated interventions in long-term care facilities. Inov Pharm. 2013;4(4):Article 135.
10. Bondesson A, Holmdahl L, Midlöv P, Höglund P, Andersson E, Eriksson T. Acceptance and importance of clinical pharmacists’ LIMM-based recommendations. Int J Clin Pharm. 2012;34(2):272-276. doi:10.1007/s11096-012-9609-3
11. US Department of Veterans Affairs. Safety assessment code (SAC) matrix. Updated June 3, 2015. Accessed May 4, 2023. https://www.patientsafety.va.gov/professionals/publications/matrix.asp
The US Coast Guard (USCG) operates within the US Department of Homeland Security during times of peace and represents a force of > 55,000 active-duty service members (ADSMs), civilians, and reservists. ADSMs account for about 40,000 USCG personnel. The missions of the USCG include activities such as maritime law enforcement (drug interdiction), search and rescue, and defense readiness.1 Akin to other US Department of Defense (DoD) services, USCG ADSMs are required to maintain medical readiness to maximize operational success.
Whereas the DoD centralizes its health care services at military treatment facilities, USCG health care tends to be dispersed to smaller clinics and sickbays across large geographic areas. The USCG operates 42 clinics of varying sizes and medical capabilities, providing outpatient, dentistry, pharmacy, laboratory, radiology, physical therapy, optometry, and other health care services. Many ADSMs are evaluated by a USCG medical officer in these outpatient clinics, and ADSMs may choose to fill prescriptions at the in-house pharmacy if present at that clinic.
The USCG has 14 field pharmacists. In addition to the standard dispensing role at their respective clinics, USCG pharmacists provide regional oversight of pharmaceutical services for USCG units within their area of responsibility (AOR). Therefore, USCG pharmacists clinically, operationally, and logistically support these regional assets within their AOR while serving the traditional pharmacist role. USCG pharmacists have access to ADSM electronic health records (EHRs) when evaluating prescription orders, similar to other ambulatory care settings.
New recruits and accessions into the USCG are first screened for disqualifying health conditions, and ADSMs are required to maintain medical readiness throughout their careers.2 Therefore, this population tends to be younger and overall healthier compared with the general population. Equally important, medication errors or inappropriate prescribing in the ADSM group could negatively affect their duty status and mission readiness of the USCG in addition to exposing the ADSM to medication-related harms.
Duty status is an important and unique consideration in this population. ADSMs are expected to be deployable worldwide and physically and mentally capable of executing all duties associated with their position. Duty status implications and the perceived ability to stand watch are tied to an ADMS’s specialty, training, and unit role. Duty status is based on various frameworks like the USCG Medical Manual, Aeromedical Policy Letters, and other governing documents.3 Duty status determinations are initiated by privileged USCG medical practitioners and may be executed in consultation with relevant commands and other subject matter experts. An inappropriately dosed antibiotic prescription, for example, can extend the duration that an ADSM would be considered unfit for full duty due to prolonged illness. Accordingly, being on a limited duty status may negatively affect USCG total mission readiness as a whole. USCG pharmacists play a vital role in optimizing ADSMs’ medication therapies to ensure safety and efficacy.
Currently no published literature explores the number of medication interventions or the impact of those interventions made by USCG pharmacists. This study aimed to quantify the number, duty status impact, and replicability of medication interventions made by one pharmacist at the USCG Base Alameda clinic over 6 months.
Methods
As part of a USCG quality improvement study, a pharmacist tracked all medication interventions on a spreadsheet at USCG Base Alameda clinic from July 1, 2021, to December 31, 2021. The study defined a medication intervention as a communication with the prescriber with the intention to change the medication, strength, dose, dosage form, quantity, or instructions. Each intervention was subcategorized as either a drug therapy problem (DTP) or a non-DTP intervention. Interventions were divided into 7 categories.
Each DTP intervention was evaluated in a retrospective chart review by a panel of USCG pharmacists to assess for duty status severity and replicability. For duty status severity, the panel reviewed the intervention after considering patient-specific factors and determined whether the original prescribing (had there not been an intervention) could have reasonably resulted in a change of duty status for the ADSM from a fit for full duty (FFFD) status to a different duty status (eg, fit for limited duty [FFLD]). This duty status review factored in potential impacts across multiple positions and billets, including aviators (pilots) and divers. In addition, the panel, whose members all have prior community pharmacy experience, assessed replicability by determining whether the same intervention could have reasonably been made in the absence of access to the patient EHR, as would be common in a community pharmacy setting.
Interventions without an identified DTP were considered non-DTP interventions. These interventions involved recommendations for a more cost-effective medication or a similar in stock therapeutic option to minimize delay of patient care. The spreadsheet also included the date, medication name, medication class, specific intervention made, outcome, and other descriptive comments.
Results
During the 6-month period, 1751 prescriptions were dispensed at USCG Base Alameda pharmacy with 116 interventions (7%).
Among the DTP interventions, 26 (41%) dealt with an inappropriate dose, 13 (20%) were for medication omission, 7 (11%) for inappropriate dosage form, and 6 (9%) for excess medication (Table 2).
Discussion
This study is novel in examining the impact of a pharmacist’s medication interventions in a USCG ambulatory care practice setting. A PubMed literature search of the phrases “Coast Guard AND pharmacy” or “Coast Guard AND pharmacy AND intervention” yielded no results specific to pharmacy interventions in a USCG setting. However, the 2021 implementation of the enterprise-wide MHS GENESIS EHR may support additional tracking and analysis tools in the future.
Pharmacist interventions have been studied in diverse patient populations and practice settings, and most conclude that pharmacists make meaningful interventions at their respective organizations.4-7 Many of these studies were conducted at open-door health care systems, whereas USCG clinics serve ADSMs nearly exclusively. The ADSM population tends to be younger and healthier due to age requirements and medical accession and retention standards.
It is important to recognize the value of a USCG pharmacist in identifying and rectifying potential medication errors, particularly those that may affect the ability to stand duty for ADSMs. An example intervention includes changing the daily starting dose of citalopram from the ordered 30 mg to the intended 10 mg. Inappropriately prescribed medication regimens may increase the incidence of adverse effects or prolong duration to therapeutic efficacy, which impairs the ability to stand duty. There were 3 circumstances where the prescriber had ordered the medication for an incorrect ADSM that were rectified by the pharmacist. If left unchanged, these errors could negatively affect the ADSM’s overall health, well-being, and duty status.
The acceptance rate for interventions in this study was 96%. The literature suggests a highly variable acceptance rate of pharmacist interventions when examined across various practice settings, health systems, and geographic locations.8-10 This study’s comparatively high rate could be due to the pharmacist-prescriber relationships at USCG clinics. By virtue of colocatation and teamwork initiatives, the pharmacist has the opportunity to develop positive rapport with physicians, physician assistants, and other clinic staff.
Having access to EHRs allowed the pharmacist to make 18 of the DTP interventions. Chart access is not unique to the USCG and is common in other ambulatory care settings. Those 18 interventions, such as reconciling a prescription ordered as fluticasone/salmeterol but recorded in the EHR as “will prescribe montelukast,” were deemed possible because of EHR access. Such interventions could potentially be lost if ADSMs solely received their pharmaceutical care elsewhere.
USCG uses independent duty health services technicians (IDHSs) who practice in settings where a medical officer is not present, such as at smaller sickbays or aboard Coast Guard cutters. In this study, an IDHS had mistakenly created a medication order for the medical officer to sign for bupropion SR, when the ADSM had been taking and was intended to continue taking bupropion XL. This order was signed off by the medical officer, but this oversight was identified and corrected by the pharmacist before dispensing. This indicates that there is a vital educational role that the USCG pharmacist fulfills when working with health care team members within the AOR.
Equally important to consider are the non-DTP interventions. In a military setting, minimizations of delay in care are a high priority. There were 34 instances where the pharmacist made an intervention to recommend a similar therapeutic medication that was in stock to ensure that the ADSM had timely access to the medication without the need for prior authorization. In the context of short-notice, mission-critical deployments that may last for multiple months, recognizing medication shortages or other inventory constraints and recommending therapeutic alternatives ensures that the USCG can maintain a ready posture for missions in addition to providing timely and quality patient care.
Saving about $1700 over 6 months is also important. While this was not explicitly evaluated in the study, prescribers may not be acutely aware of medication pricing. There are often significant price differences between different formulations of the same medication (eg, naproxen delayed-release vs tablets). Because USCG pharmacists are responsible for ordering medications and managing their regional budget within the AOR, they are best poised to make cost-savings recommendations. These interventions suggest that USCG pharmacists must continue to remain actively involved in the patient care team alongside physicians, physician assistants, nurses, and corpsmen. Throughout this setting and in so many others, patients’ health outcomes improve when pharmacists are more engaged in the pharmacotherapy care plan.
Limitations
Currently, the USCG does not publish ADSM demographic or health-related data, making it difficult to evaluate these interventions in the context of age, gender, or type of disease. Accordingly, potential directions for future research include how USCG pharmacists’ interventions are stratified by duty station and initial diagnosis. Such studies may support future models where USCG pharmacists are providing targeted education to prescribers based on disease or medication classes.
This analysis may have limited applicability to other practice settings even within USCG. Most USCG clinics have a limited number of medical officers; indeed, many have only one, and clinics with pharmacies typically have 1 to 5 medical officers aboard. USCG medical officers have a multitude of other duties, which may impact prescribing patterns and pharmacist interventions. Statistical analyses were limited by the dearth of baseline data or comparative literature. Finally, the assessment of DTP interventions’ impact did not use an official measurement tool like the US Department of Veterans Affairs’ Safety Assessment Code matrix.11 Instead, the study used the internal USCG pharmacist panel for the fitness for duty consideration as the main stratification of the DTP interventions’ duty status severity, because maintaining medical readiness is the top priority for a USCG clinic.
Conclusions
The multifaceted role of pharmacists in USCG clinics includes collaborating with the patient care team to make pharmacy interventions that have significant impacts on ADSMs’ wellness and the USCG mission. The ADSMs of this nation deserve quality medical care that translates into mission readiness, and the USCG pharmacy force stands ready to support that goal.
Acknowledgments
The authors acknowledge the contributions of CDR Christopher Janik, US Coast Guard Headquarters, and LCDR Darin Schneider, US Coast Guard D11 Regional Practice Manager, in the drafting of the manuscript.
The US Coast Guard (USCG) operates within the US Department of Homeland Security during times of peace and represents a force of > 55,000 active-duty service members (ADSMs), civilians, and reservists. ADSMs account for about 40,000 USCG personnel. The missions of the USCG include activities such as maritime law enforcement (drug interdiction), search and rescue, and defense readiness.1 Akin to other US Department of Defense (DoD) services, USCG ADSMs are required to maintain medical readiness to maximize operational success.
Whereas the DoD centralizes its health care services at military treatment facilities, USCG health care tends to be dispersed to smaller clinics and sickbays across large geographic areas. The USCG operates 42 clinics of varying sizes and medical capabilities, providing outpatient, dentistry, pharmacy, laboratory, radiology, physical therapy, optometry, and other health care services. Many ADSMs are evaluated by a USCG medical officer in these outpatient clinics, and ADSMs may choose to fill prescriptions at the in-house pharmacy if present at that clinic.
The USCG has 14 field pharmacists. In addition to the standard dispensing role at their respective clinics, USCG pharmacists provide regional oversight of pharmaceutical services for USCG units within their area of responsibility (AOR). Therefore, USCG pharmacists clinically, operationally, and logistically support these regional assets within their AOR while serving the traditional pharmacist role. USCG pharmacists have access to ADSM electronic health records (EHRs) when evaluating prescription orders, similar to other ambulatory care settings.
New recruits and accessions into the USCG are first screened for disqualifying health conditions, and ADSMs are required to maintain medical readiness throughout their careers.2 Therefore, this population tends to be younger and overall healthier compared with the general population. Equally important, medication errors or inappropriate prescribing in the ADSM group could negatively affect their duty status and mission readiness of the USCG in addition to exposing the ADSM to medication-related harms.
Duty status is an important and unique consideration in this population. ADSMs are expected to be deployable worldwide and physically and mentally capable of executing all duties associated with their position. Duty status implications and the perceived ability to stand watch are tied to an ADMS’s specialty, training, and unit role. Duty status is based on various frameworks like the USCG Medical Manual, Aeromedical Policy Letters, and other governing documents.3 Duty status determinations are initiated by privileged USCG medical practitioners and may be executed in consultation with relevant commands and other subject matter experts. An inappropriately dosed antibiotic prescription, for example, can extend the duration that an ADSM would be considered unfit for full duty due to prolonged illness. Accordingly, being on a limited duty status may negatively affect USCG total mission readiness as a whole. USCG pharmacists play a vital role in optimizing ADSMs’ medication therapies to ensure safety and efficacy.
Currently no published literature explores the number of medication interventions or the impact of those interventions made by USCG pharmacists. This study aimed to quantify the number, duty status impact, and replicability of medication interventions made by one pharmacist at the USCG Base Alameda clinic over 6 months.
Methods
As part of a USCG quality improvement study, a pharmacist tracked all medication interventions on a spreadsheet at USCG Base Alameda clinic from July 1, 2021, to December 31, 2021. The study defined a medication intervention as a communication with the prescriber with the intention to change the medication, strength, dose, dosage form, quantity, or instructions. Each intervention was subcategorized as either a drug therapy problem (DTP) or a non-DTP intervention. Interventions were divided into 7 categories.
Each DTP intervention was evaluated in a retrospective chart review by a panel of USCG pharmacists to assess for duty status severity and replicability. For duty status severity, the panel reviewed the intervention after considering patient-specific factors and determined whether the original prescribing (had there not been an intervention) could have reasonably resulted in a change of duty status for the ADSM from a fit for full duty (FFFD) status to a different duty status (eg, fit for limited duty [FFLD]). This duty status review factored in potential impacts across multiple positions and billets, including aviators (pilots) and divers. In addition, the panel, whose members all have prior community pharmacy experience, assessed replicability by determining whether the same intervention could have reasonably been made in the absence of access to the patient EHR, as would be common in a community pharmacy setting.
Interventions without an identified DTP were considered non-DTP interventions. These interventions involved recommendations for a more cost-effective medication or a similar in stock therapeutic option to minimize delay of patient care. The spreadsheet also included the date, medication name, medication class, specific intervention made, outcome, and other descriptive comments.
Results
During the 6-month period, 1751 prescriptions were dispensed at USCG Base Alameda pharmacy with 116 interventions (7%).
Among the DTP interventions, 26 (41%) dealt with an inappropriate dose, 13 (20%) were for medication omission, 7 (11%) for inappropriate dosage form, and 6 (9%) for excess medication (Table 2).
Discussion
This study is novel in examining the impact of a pharmacist’s medication interventions in a USCG ambulatory care practice setting. A PubMed literature search of the phrases “Coast Guard AND pharmacy” or “Coast Guard AND pharmacy AND intervention” yielded no results specific to pharmacy interventions in a USCG setting. However, the 2021 implementation of the enterprise-wide MHS GENESIS EHR may support additional tracking and analysis tools in the future.
Pharmacist interventions have been studied in diverse patient populations and practice settings, and most conclude that pharmacists make meaningful interventions at their respective organizations.4-7 Many of these studies were conducted at open-door health care systems, whereas USCG clinics serve ADSMs nearly exclusively. The ADSM population tends to be younger and healthier due to age requirements and medical accession and retention standards.
It is important to recognize the value of a USCG pharmacist in identifying and rectifying potential medication errors, particularly those that may affect the ability to stand duty for ADSMs. An example intervention includes changing the daily starting dose of citalopram from the ordered 30 mg to the intended 10 mg. Inappropriately prescribed medication regimens may increase the incidence of adverse effects or prolong duration to therapeutic efficacy, which impairs the ability to stand duty. There were 3 circumstances where the prescriber had ordered the medication for an incorrect ADSM that were rectified by the pharmacist. If left unchanged, these errors could negatively affect the ADSM’s overall health, well-being, and duty status.
The acceptance rate for interventions in this study was 96%. The literature suggests a highly variable acceptance rate of pharmacist interventions when examined across various practice settings, health systems, and geographic locations.8-10 This study’s comparatively high rate could be due to the pharmacist-prescriber relationships at USCG clinics. By virtue of colocatation and teamwork initiatives, the pharmacist has the opportunity to develop positive rapport with physicians, physician assistants, and other clinic staff.
Having access to EHRs allowed the pharmacist to make 18 of the DTP interventions. Chart access is not unique to the USCG and is common in other ambulatory care settings. Those 18 interventions, such as reconciling a prescription ordered as fluticasone/salmeterol but recorded in the EHR as “will prescribe montelukast,” were deemed possible because of EHR access. Such interventions could potentially be lost if ADSMs solely received their pharmaceutical care elsewhere.
USCG uses independent duty health services technicians (IDHSs) who practice in settings where a medical officer is not present, such as at smaller sickbays or aboard Coast Guard cutters. In this study, an IDHS had mistakenly created a medication order for the medical officer to sign for bupropion SR, when the ADSM had been taking and was intended to continue taking bupropion XL. This order was signed off by the medical officer, but this oversight was identified and corrected by the pharmacist before dispensing. This indicates that there is a vital educational role that the USCG pharmacist fulfills when working with health care team members within the AOR.
Equally important to consider are the non-DTP interventions. In a military setting, minimizations of delay in care are a high priority. There were 34 instances where the pharmacist made an intervention to recommend a similar therapeutic medication that was in stock to ensure that the ADSM had timely access to the medication without the need for prior authorization. In the context of short-notice, mission-critical deployments that may last for multiple months, recognizing medication shortages or other inventory constraints and recommending therapeutic alternatives ensures that the USCG can maintain a ready posture for missions in addition to providing timely and quality patient care.
Saving about $1700 over 6 months is also important. While this was not explicitly evaluated in the study, prescribers may not be acutely aware of medication pricing. There are often significant price differences between different formulations of the same medication (eg, naproxen delayed-release vs tablets). Because USCG pharmacists are responsible for ordering medications and managing their regional budget within the AOR, they are best poised to make cost-savings recommendations. These interventions suggest that USCG pharmacists must continue to remain actively involved in the patient care team alongside physicians, physician assistants, nurses, and corpsmen. Throughout this setting and in so many others, patients’ health outcomes improve when pharmacists are more engaged in the pharmacotherapy care plan.
Limitations
Currently, the USCG does not publish ADSM demographic or health-related data, making it difficult to evaluate these interventions in the context of age, gender, or type of disease. Accordingly, potential directions for future research include how USCG pharmacists’ interventions are stratified by duty station and initial diagnosis. Such studies may support future models where USCG pharmacists are providing targeted education to prescribers based on disease or medication classes.
This analysis may have limited applicability to other practice settings even within USCG. Most USCG clinics have a limited number of medical officers; indeed, many have only one, and clinics with pharmacies typically have 1 to 5 medical officers aboard. USCG medical officers have a multitude of other duties, which may impact prescribing patterns and pharmacist interventions. Statistical analyses were limited by the dearth of baseline data or comparative literature. Finally, the assessment of DTP interventions’ impact did not use an official measurement tool like the US Department of Veterans Affairs’ Safety Assessment Code matrix.11 Instead, the study used the internal USCG pharmacist panel for the fitness for duty consideration as the main stratification of the DTP interventions’ duty status severity, because maintaining medical readiness is the top priority for a USCG clinic.
Conclusions
The multifaceted role of pharmacists in USCG clinics includes collaborating with the patient care team to make pharmacy interventions that have significant impacts on ADSMs’ wellness and the USCG mission. The ADSMs of this nation deserve quality medical care that translates into mission readiness, and the USCG pharmacy force stands ready to support that goal.
Acknowledgments
The authors acknowledge the contributions of CDR Christopher Janik, US Coast Guard Headquarters, and LCDR Darin Schneider, US Coast Guard D11 Regional Practice Manager, in the drafting of the manuscript.
1. US Coast Guard. Missions. Accessed May 4, 2023. https://www.uscg.mil/About/Missions
2. US Coast Guard. Coast Guard Medical Manual. Updated September 13, 2022. Accessed May 4, 2023. https://media.defense.gov/2022/Sep/14/2003076969/-1/-1/0/CIM_6000_1F.PDF
3. US Coast Guard. USCG Aeromedical Policy Letters. Accessed May 5, 2023. https://www.dcms.uscg.mil/Portals/10/CG-1/cg112/cg1121/docs/pdf/USCG_Aeromedical_Policy_Letters.pdf
4. Bedouch P, Sylvoz N, Charpiat B, et al. Trends in pharmacists’ medication order review in French hospitals from 2006 to 2009: analysis of pharmacists’ interventions from the Act-IP website observatory. J Clin Pharm Ther. 2015;40(1):32-40. doi:10.1111/jcpt.12214
5. Ooi PL, Zainal H, Lean QY, Ming LC, Ibrahim B. Pharmacists’ interventions on electronic prescriptions from various specialty wards in a Malaysian public hospital: a cross-sectional study. Pharmacy (Basel). 2021;9(4):161. Published 2021 Oct 1. doi:10.3390/pharmacy9040161
6. Alomi YA, El-Bahnasawi M, Kamran M, Shaweesh T, Alhaj S, Radwan RA. The clinical outcomes of pharmacist interventions at critical care services of private hospital in Riyadh City, Saudi Arabia. PTB Report. 2019;5(1):16-19. doi:10.5530/ptb.2019.5.4
7. Garin N, Sole N, Lucas B, et al. Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions. Sci Rep. 2021;11(1):883. Published 2021 Jan 13. doi:10.1038/s41598-020-80560-2
8. Zaal RJ, den Haak EW, Andrinopoulou ER, van Gelder T, Vulto AG, van den Bemt PMLA. Physicians’ acceptance of pharmacists’ interventions in daily hospital practice. Int J Clin Pharm. 2020;42(1):141-149. doi:10.1007/s11096-020-00970-0
9. Carson GL, Crosby K, Huxall GR, Brahm NC. Acceptance rates for pharmacist-initiated interventions in long-term care facilities. Inov Pharm. 2013;4(4):Article 135.
10. Bondesson A, Holmdahl L, Midlöv P, Höglund P, Andersson E, Eriksson T. Acceptance and importance of clinical pharmacists’ LIMM-based recommendations. Int J Clin Pharm. 2012;34(2):272-276. doi:10.1007/s11096-012-9609-3
11. US Department of Veterans Affairs. Safety assessment code (SAC) matrix. Updated June 3, 2015. Accessed May 4, 2023. https://www.patientsafety.va.gov/professionals/publications/matrix.asp
1. US Coast Guard. Missions. Accessed May 4, 2023. https://www.uscg.mil/About/Missions
2. US Coast Guard. Coast Guard Medical Manual. Updated September 13, 2022. Accessed May 4, 2023. https://media.defense.gov/2022/Sep/14/2003076969/-1/-1/0/CIM_6000_1F.PDF
3. US Coast Guard. USCG Aeromedical Policy Letters. Accessed May 5, 2023. https://www.dcms.uscg.mil/Portals/10/CG-1/cg112/cg1121/docs/pdf/USCG_Aeromedical_Policy_Letters.pdf
4. Bedouch P, Sylvoz N, Charpiat B, et al. Trends in pharmacists’ medication order review in French hospitals from 2006 to 2009: analysis of pharmacists’ interventions from the Act-IP website observatory. J Clin Pharm Ther. 2015;40(1):32-40. doi:10.1111/jcpt.12214
5. Ooi PL, Zainal H, Lean QY, Ming LC, Ibrahim B. Pharmacists’ interventions on electronic prescriptions from various specialty wards in a Malaysian public hospital: a cross-sectional study. Pharmacy (Basel). 2021;9(4):161. Published 2021 Oct 1. doi:10.3390/pharmacy9040161
6. Alomi YA, El-Bahnasawi M, Kamran M, Shaweesh T, Alhaj S, Radwan RA. The clinical outcomes of pharmacist interventions at critical care services of private hospital in Riyadh City, Saudi Arabia. PTB Report. 2019;5(1):16-19. doi:10.5530/ptb.2019.5.4
7. Garin N, Sole N, Lucas B, et al. Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions. Sci Rep. 2021;11(1):883. Published 2021 Jan 13. doi:10.1038/s41598-020-80560-2
8. Zaal RJ, den Haak EW, Andrinopoulou ER, van Gelder T, Vulto AG, van den Bemt PMLA. Physicians’ acceptance of pharmacists’ interventions in daily hospital practice. Int J Clin Pharm. 2020;42(1):141-149. doi:10.1007/s11096-020-00970-0
9. Carson GL, Crosby K, Huxall GR, Brahm NC. Acceptance rates for pharmacist-initiated interventions in long-term care facilities. Inov Pharm. 2013;4(4):Article 135.
10. Bondesson A, Holmdahl L, Midlöv P, Höglund P, Andersson E, Eriksson T. Acceptance and importance of clinical pharmacists’ LIMM-based recommendations. Int J Clin Pharm. 2012;34(2):272-276. doi:10.1007/s11096-012-9609-3
11. US Department of Veterans Affairs. Safety assessment code (SAC) matrix. Updated June 3, 2015. Accessed May 4, 2023. https://www.patientsafety.va.gov/professionals/publications/matrix.asp
Widespread carboplatin, cisplatin shortages: NCCN survey
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.