Federal Practitioner

The COVID-19 pandemic fueled a sharp uptick in deaths related to chronic liver disease and cirrhosis among people with diabetes, largely owing to nonalcoholic fatty liver disease (NAFLD) and alcohol-related liver disease (ALD), new data show.

“Our observations confirm that COVID-19 had a higher likelihood of impacting vulnerable populations with pre-existing chronic liver diseases and diabetes, with a death rate as high as 10% in individuals with co-existing chronic liver disease and diabetes,” write the authors.

“The inability to attend regular outpatient clinics for close monitoring and treatment accompanied by diversion of health care resources to COVID-19 care may have resulted in the suboptimal or delayed clinical care of individuals with diabetes and chronic liver disease during the COVID-19 pandemic,” they add.

Donghee Kim, MD, PhD, with the Division of Gastroenterology and Hepatology, Stanford (Calif.) University School of Medicine, and colleagues report their findings in the journal Digestive and Liver Disease.
 

Vulnerable group

The researchers used U.S. national mortality data (2017-2020) to estimate chronic liver disease–related mortality trends among individuals with diabetes before and during the COVID-19 pandemic.

Before the pandemic, the quarterly mortality for chronic liver disease remained stable (quarterly percentage change, 0.6%) but then sharply increased during the pandemic (QPC, 8.6%).

A similar trend was seen with cirrhosis-related mortality (QPC, 0.3% before the pandemic vs. 8.4% during the pandemic).

NAFLD and ALD mortality among individuals with diabetes was steadily increasing before the pandemic (QPC, 4.2% and 3.5%, respectively) but showed a more rapid increase during the pandemic (QPC, 9.6% and 7.7%, respectively).

ALD-related mortality in men was more than threefold higher than in women, while NAFLD-related mortality in women was more than twofold higher than in men.

Mortality for hepatitis C virus infection declined before the pandemic (QPC, −3.3%) and remained stable during the pandemic.

COVID-19–related mortality among adults with chronic liver disease and diabetes also rose sharply during the pandemic – from 0.4% in the first quarter of 2020 to 12.9% in the last quarter of 2020 – with no considerable difference between men and women.
 

Blame it on lockdowns?

Dr. Kim and colleagues say research is needed to better understand the direct and indirect influence of COVID-19 on coexisting chronic liver disease and diabetes.

“It is plausible that psychosocial stress and a higher predisposition to psychiatric disorders during the COVID-19 pandemic can increase the risk of alcohol use disorder and ALD,” they write.

“Furthermore, it is prudent to suspect that COVID-19–related lockdowns may increase the risk of obesity, leading to a higher risk of insulin resistance and metabolic complications, including diabetes and NAFLD. Future studies are needed to improve our understanding of these possible pathogenetic links. More importantly, emergency preparedness or contingency plans must be in place to continue and provide uninterrupted care for chronic ailments during times of disaster,” they add.

The study had no specific funding. The authors report no relevant financial relationships.

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

The COVID-19 pandemic fueled a sharp uptick in deaths related to chronic liver disease and cirrhosis among people with diabetes, largely owing to nonalcoholic fatty liver disease (NAFLD) and alcohol-related liver disease (ALD), new data show.

“Our observations confirm that COVID-19 had a higher likelihood of impacting vulnerable populations with pre-existing chronic liver diseases and diabetes, with a death rate as high as 10% in individuals with co-existing chronic liver disease and diabetes,” write the authors.

“The inability to attend regular outpatient clinics for close monitoring and treatment accompanied by diversion of health care resources to COVID-19 care may have resulted in the suboptimal or delayed clinical care of individuals with diabetes and chronic liver disease during the COVID-19 pandemic,” they add.

Donghee Kim, MD, PhD, with the Division of Gastroenterology and Hepatology, Stanford (Calif.) University School of Medicine, and colleagues report their findings in the journal Digestive and Liver Disease.
 

Vulnerable group

The researchers used U.S. national mortality data (2017-2020) to estimate chronic liver disease–related mortality trends among individuals with diabetes before and during the COVID-19 pandemic.

Before the pandemic, the quarterly mortality for chronic liver disease remained stable (quarterly percentage change, 0.6%) but then sharply increased during the pandemic (QPC, 8.6%).

A similar trend was seen with cirrhosis-related mortality (QPC, 0.3% before the pandemic vs. 8.4% during the pandemic).

NAFLD and ALD mortality among individuals with diabetes was steadily increasing before the pandemic (QPC, 4.2% and 3.5%, respectively) but showed a more rapid increase during the pandemic (QPC, 9.6% and 7.7%, respectively).

ALD-related mortality in men was more than threefold higher than in women, while NAFLD-related mortality in women was more than twofold higher than in men.

Mortality for hepatitis C virus infection declined before the pandemic (QPC, −3.3%) and remained stable during the pandemic.

COVID-19–related mortality among adults with chronic liver disease and diabetes also rose sharply during the pandemic – from 0.4% in the first quarter of 2020 to 12.9% in the last quarter of 2020 – with no considerable difference between men and women.
 

Blame it on lockdowns?

Dr. Kim and colleagues say research is needed to better understand the direct and indirect influence of COVID-19 on coexisting chronic liver disease and diabetes.

“It is plausible that psychosocial stress and a higher predisposition to psychiatric disorders during the COVID-19 pandemic can increase the risk of alcohol use disorder and ALD,” they write.

“Furthermore, it is prudent to suspect that COVID-19–related lockdowns may increase the risk of obesity, leading to a higher risk of insulin resistance and metabolic complications, including diabetes and NAFLD. Future studies are needed to improve our understanding of these possible pathogenetic links. More importantly, emergency preparedness or contingency plans must be in place to continue and provide uninterrupted care for chronic ailments during times of disaster,” they add.

The study had no specific funding. The authors report no relevant financial relationships.

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

The COVID-19 pandemic fueled a sharp uptick in deaths related to chronic liver disease and cirrhosis among people with diabetes, largely owing to nonalcoholic fatty liver disease (NAFLD) and alcohol-related liver disease (ALD), new data show.

“Our observations confirm that COVID-19 had a higher likelihood of impacting vulnerable populations with pre-existing chronic liver diseases and diabetes, with a death rate as high as 10% in individuals with co-existing chronic liver disease and diabetes,” write the authors.

“The inability to attend regular outpatient clinics for close monitoring and treatment accompanied by diversion of health care resources to COVID-19 care may have resulted in the suboptimal or delayed clinical care of individuals with diabetes and chronic liver disease during the COVID-19 pandemic,” they add.

Donghee Kim, MD, PhD, with the Division of Gastroenterology and Hepatology, Stanford (Calif.) University School of Medicine, and colleagues report their findings in the journal Digestive and Liver Disease.
 

Vulnerable group

The researchers used U.S. national mortality data (2017-2020) to estimate chronic liver disease–related mortality trends among individuals with diabetes before and during the COVID-19 pandemic.

Before the pandemic, the quarterly mortality for chronic liver disease remained stable (quarterly percentage change, 0.6%) but then sharply increased during the pandemic (QPC, 8.6%).

A similar trend was seen with cirrhosis-related mortality (QPC, 0.3% before the pandemic vs. 8.4% during the pandemic).

NAFLD and ALD mortality among individuals with diabetes was steadily increasing before the pandemic (QPC, 4.2% and 3.5%, respectively) but showed a more rapid increase during the pandemic (QPC, 9.6% and 7.7%, respectively).

ALD-related mortality in men was more than threefold higher than in women, while NAFLD-related mortality in women was more than twofold higher than in men.

Mortality for hepatitis C virus infection declined before the pandemic (QPC, −3.3%) and remained stable during the pandemic.

COVID-19–related mortality among adults with chronic liver disease and diabetes also rose sharply during the pandemic – from 0.4% in the first quarter of 2020 to 12.9% in the last quarter of 2020 – with no considerable difference between men and women.
 

Blame it on lockdowns?

Dr. Kim and colleagues say research is needed to better understand the direct and indirect influence of COVID-19 on coexisting chronic liver disease and diabetes.

“It is plausible that psychosocial stress and a higher predisposition to psychiatric disorders during the COVID-19 pandemic can increase the risk of alcohol use disorder and ALD,” they write.

“Furthermore, it is prudent to suspect that COVID-19–related lockdowns may increase the risk of obesity, leading to a higher risk of insulin resistance and metabolic complications, including diabetes and NAFLD. Future studies are needed to improve our understanding of these possible pathogenetic links. More importantly, emergency preparedness or contingency plans must be in place to continue and provide uninterrupted care for chronic ailments during times of disaster,” they add.

The study had no specific funding. The authors report no relevant financial relationships.

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

VIENNA – Sexual dysfunction in patients with gastrointestinal disorders is undermanaged, with a lack of clinician education, time constraints, and embarrassment preventing constructive discussions to improve patient care and quality of life, according to a new survey.

Overall, 71% of gastroenterologists do not ask their patients about sexual dysfunction, the survey finds.

“While patients with gastrointestinal disorders often experience sexual dysfunction, discussions around the matter are not routine in gastroenterological care,” said Marco Romano, MD, from the University of Campania “Luigi Vanvitelli,” Naples, Italy.

Romano presented the survey findings at this year’s United European Gastroenterology Week meeting.

The research shows not only a clear need for better awareness but also a need to build gastroenterologists’ confidence in addressing sexual dysfunction with their patients, Dr. Romano added.

“Most felt that sexual medicine education and improvement of communication skills within the context of their residency training might be important in order to increase the awareness of sexual dysfunction, to overcome barriers, and to improve care and quality of life for their patients,” reported Dr. Romano. “This will lead to prompt diagnosis and treatment of any sexual problems.”

Respectfully asking the patients if their gastrointestinal disorders interfere with their intimate relationships “is often considered a relief to patients who find that the gastrointestinal problem and the sexual dysfunction are interlinked,” he added.
 

The findings

The survey was needed because the question of whether gastroenterologists inquire about their patients’ sexual issues had never been assessed, Dr. Romano said.

The researchers sent a cross-sectional, anonymous online survey to members of the Italian Society of Gastroenterology and Digestive Endoscopy. The questionnaire, designed and informed by a literature review, consisted of 29 single multiple-choice and open-ended questions.

A total of 426 surveys were returned: 335 from experienced gastroenterologists and 91 from residents (less experienced). Of all respondents, 54.7% were men and 45.3% were women.

Even though most gastroenterologists do not ask their patients about sexual dysfunction, the majority want to learn how to manage the issue, the survey found. Of the survey respondents, 80% agreed that it would be useful for gastroenterologists to attend courses dedicated to the problem of sexual dysfunction.

Only 4% of patients report (initiate a dialogue about) the problem, the survey found. Among women aged 40-50 years, the most common complaint reported was dyspareunia (pain on intercourse). In men, the most frequent complaints reported were in the over-40s age group, with 75% citing erectile dysfunction and 45% reporting loss of libido.

The most common gastrointestinal disorders associated with sexual dysfunction are inflammatory bowel diseases (37% of cases), chronic liver diseases (28%), and irritable bowel syndrome (26%), according to the survey.

On the question of whether medications played a role in patients’ sexual dysfunction, nearly 15% of respondents said that prokinetic agents were involved, and 18% thought proton pump inhibitors affect sexual function. Both drug classes are considered responsible for sexual disturbances.

Few gastroenterologists prescribe phosphodiesterase type 5 inhibitors (PDE5i), e.g., Viagra, to treat sexual dysfunction, the survey found. Approximately 90% of respondents said that they never prescribed this class of drugs, preferring to refer patients to an andrologist. Of those who did prescribe PDE5i, significantly fewer residents did compared with experienced gastroenterologists (1.1% vs. 8.8%, respectively; P = .01).

Finally, the biggest reasons why gastroenterologists do not discuss sexual dysfunction are lack of knowledge (80%), insufficient experience (58%), time (44%), and embarrassment (30%).
 

Practice experience matters

There were some differences among respondents in the experienced group vs. the residents. More men were in the experienced group compared with residents (57.6% vs. 44%, respectively); mean age was 47 years vs. 29 years, respectively; and 71% had 5 or more years of experience in the experienced gastroenterologist group, whereas 78% had 1-5 years of experience among residents.

The survey found that more residents than experienced gastroenterologists “never discussed sexual dysfunction” (38.5% vs. 21.3%, respectively; P = .001) and that more residents than experienced gastroenterologists reported that “patients did not relate their sexual dysfunction to the prescribed therapy” (47.8% vs. 32.5%, respectively; P = .007).

The two groups varied regarding prescription drugs’ role in sexual dysfunction. More experienced gastroenterologists than residents felt that proton pump inhibitors (5.8% vs. 0%, respectively; P = .018) or prokinetics (19.8% vs. 9.5%, respectively; P = .028) might be responsible for some degree of sexual dysfunction.

More residents than experienced doctors felt that other (nongastroenterologic) drugs might contribute to sexual dysfunction in their patients (57.1% vs. 44.7%, respectively; P = .043).

Dr. Romano reported that fewer residents than experienced gastroenterologists referred male patients with sexual dysfunction to an andrologist (frequently/always: 28.1% vs. 44.4%, respectively; P = .004). However, more residents than experienced gastroenterologists disagreed that discussing sexual dysfunction with patients pertains only to specialists (andrologists and gynecologists; 83.5% vs. 71.2%, respectively; P = .018).
 

Time to step up

Asma Fikree, BMBCh, PhD, of Royal London Hospital, Barts Health NHS Trust, London, moderated the session. The survey highlights that asking patients about sexual dysfunction is an area for improvement for gastroenterologists, she said.

“We might do it in men and ask about erectile dysfunction, but we are very poor about asking in women,” Dr. Fikree noted.

The pros and cons of different medications should be discussed with patients, she said.

Gastroenterologists need to do a better job of considering how medications can lead to sexual dysfunction and interfere with quality of life, and training would help, she added.

“Some patients might not be very bothered by sexual dysfunction, but others might consider it very important,” Dr. Fikree said. “We should be considering this as part of their treatment and care.”

Dr. Romano and Dr. Fikree report no relevant financial relationships.

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

VIENNA – Sexual dysfunction in patients with gastrointestinal disorders is undermanaged, with a lack of clinician education, time constraints, and embarrassment preventing constructive discussions to improve patient care and quality of life, according to a new survey.

Overall, 71% of gastroenterologists do not ask their patients about sexual dysfunction, the survey finds.

“While patients with gastrointestinal disorders often experience sexual dysfunction, discussions around the matter are not routine in gastroenterological care,” said Marco Romano, MD, from the University of Campania “Luigi Vanvitelli,” Naples, Italy.

Romano presented the survey findings at this year’s United European Gastroenterology Week meeting.

The research shows not only a clear need for better awareness but also a need to build gastroenterologists’ confidence in addressing sexual dysfunction with their patients, Dr. Romano added.

“Most felt that sexual medicine education and improvement of communication skills within the context of their residency training might be important in order to increase the awareness of sexual dysfunction, to overcome barriers, and to improve care and quality of life for their patients,” reported Dr. Romano. “This will lead to prompt diagnosis and treatment of any sexual problems.”

Respectfully asking the patients if their gastrointestinal disorders interfere with their intimate relationships “is often considered a relief to patients who find that the gastrointestinal problem and the sexual dysfunction are interlinked,” he added.
 

The findings

The survey was needed because the question of whether gastroenterologists inquire about their patients’ sexual issues had never been assessed, Dr. Romano said.

The researchers sent a cross-sectional, anonymous online survey to members of the Italian Society of Gastroenterology and Digestive Endoscopy. The questionnaire, designed and informed by a literature review, consisted of 29 single multiple-choice and open-ended questions.

A total of 426 surveys were returned: 335 from experienced gastroenterologists and 91 from residents (less experienced). Of all respondents, 54.7% were men and 45.3% were women.

Even though most gastroenterologists do not ask their patients about sexual dysfunction, the majority want to learn how to manage the issue, the survey found. Of the survey respondents, 80% agreed that it would be useful for gastroenterologists to attend courses dedicated to the problem of sexual dysfunction.

Only 4% of patients report (initiate a dialogue about) the problem, the survey found. Among women aged 40-50 years, the most common complaint reported was dyspareunia (pain on intercourse). In men, the most frequent complaints reported were in the over-40s age group, with 75% citing erectile dysfunction and 45% reporting loss of libido.

The most common gastrointestinal disorders associated with sexual dysfunction are inflammatory bowel diseases (37% of cases), chronic liver diseases (28%), and irritable bowel syndrome (26%), according to the survey.

On the question of whether medications played a role in patients’ sexual dysfunction, nearly 15% of respondents said that prokinetic agents were involved, and 18% thought proton pump inhibitors affect sexual function. Both drug classes are considered responsible for sexual disturbances.

Few gastroenterologists prescribe phosphodiesterase type 5 inhibitors (PDE5i), e.g., Viagra, to treat sexual dysfunction, the survey found. Approximately 90% of respondents said that they never prescribed this class of drugs, preferring to refer patients to an andrologist. Of those who did prescribe PDE5i, significantly fewer residents did compared with experienced gastroenterologists (1.1% vs. 8.8%, respectively; P = .01).

Finally, the biggest reasons why gastroenterologists do not discuss sexual dysfunction are lack of knowledge (80%), insufficient experience (58%), time (44%), and embarrassment (30%).
 

Practice experience matters

There were some differences among respondents in the experienced group vs. the residents. More men were in the experienced group compared with residents (57.6% vs. 44%, respectively); mean age was 47 years vs. 29 years, respectively; and 71% had 5 or more years of experience in the experienced gastroenterologist group, whereas 78% had 1-5 years of experience among residents.

The survey found that more residents than experienced gastroenterologists “never discussed sexual dysfunction” (38.5% vs. 21.3%, respectively; P = .001) and that more residents than experienced gastroenterologists reported that “patients did not relate their sexual dysfunction to the prescribed therapy” (47.8% vs. 32.5%, respectively; P = .007).

The two groups varied regarding prescription drugs’ role in sexual dysfunction. More experienced gastroenterologists than residents felt that proton pump inhibitors (5.8% vs. 0%, respectively; P = .018) or prokinetics (19.8% vs. 9.5%, respectively; P = .028) might be responsible for some degree of sexual dysfunction.

More residents than experienced doctors felt that other (nongastroenterologic) drugs might contribute to sexual dysfunction in their patients (57.1% vs. 44.7%, respectively; P = .043).

Dr. Romano reported that fewer residents than experienced gastroenterologists referred male patients with sexual dysfunction to an andrologist (frequently/always: 28.1% vs. 44.4%, respectively; P = .004). However, more residents than experienced gastroenterologists disagreed that discussing sexual dysfunction with patients pertains only to specialists (andrologists and gynecologists; 83.5% vs. 71.2%, respectively; P = .018).
 

Time to step up

Asma Fikree, BMBCh, PhD, of Royal London Hospital, Barts Health NHS Trust, London, moderated the session. The survey highlights that asking patients about sexual dysfunction is an area for improvement for gastroenterologists, she said.

“We might do it in men and ask about erectile dysfunction, but we are very poor about asking in women,” Dr. Fikree noted.

The pros and cons of different medications should be discussed with patients, she said.

Gastroenterologists need to do a better job of considering how medications can lead to sexual dysfunction and interfere with quality of life, and training would help, she added.

“Some patients might not be very bothered by sexual dysfunction, but others might consider it very important,” Dr. Fikree said. “We should be considering this as part of their treatment and care.”

Dr. Romano and Dr. Fikree report no relevant financial relationships.

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

VIENNA – Sexual dysfunction in patients with gastrointestinal disorders is undermanaged, with a lack of clinician education, time constraints, and embarrassment preventing constructive discussions to improve patient care and quality of life, according to a new survey.

Overall, 71% of gastroenterologists do not ask their patients about sexual dysfunction, the survey finds.

“While patients with gastrointestinal disorders often experience sexual dysfunction, discussions around the matter are not routine in gastroenterological care,” said Marco Romano, MD, from the University of Campania “Luigi Vanvitelli,” Naples, Italy.

Romano presented the survey findings at this year’s United European Gastroenterology Week meeting.

The research shows not only a clear need for better awareness but also a need to build gastroenterologists’ confidence in addressing sexual dysfunction with their patients, Dr. Romano added.

“Most felt that sexual medicine education and improvement of communication skills within the context of their residency training might be important in order to increase the awareness of sexual dysfunction, to overcome barriers, and to improve care and quality of life for their patients,” reported Dr. Romano. “This will lead to prompt diagnosis and treatment of any sexual problems.”

Respectfully asking the patients if their gastrointestinal disorders interfere with their intimate relationships “is often considered a relief to patients who find that the gastrointestinal problem and the sexual dysfunction are interlinked,” he added.
 

The findings

The survey was needed because the question of whether gastroenterologists inquire about their patients’ sexual issues had never been assessed, Dr. Romano said.

The researchers sent a cross-sectional, anonymous online survey to members of the Italian Society of Gastroenterology and Digestive Endoscopy. The questionnaire, designed and informed by a literature review, consisted of 29 single multiple-choice and open-ended questions.

A total of 426 surveys were returned: 335 from experienced gastroenterologists and 91 from residents (less experienced). Of all respondents, 54.7% were men and 45.3% were women.

Even though most gastroenterologists do not ask their patients about sexual dysfunction, the majority want to learn how to manage the issue, the survey found. Of the survey respondents, 80% agreed that it would be useful for gastroenterologists to attend courses dedicated to the problem of sexual dysfunction.

Only 4% of patients report (initiate a dialogue about) the problem, the survey found. Among women aged 40-50 years, the most common complaint reported was dyspareunia (pain on intercourse). In men, the most frequent complaints reported were in the over-40s age group, with 75% citing erectile dysfunction and 45% reporting loss of libido.

The most common gastrointestinal disorders associated with sexual dysfunction are inflammatory bowel diseases (37% of cases), chronic liver diseases (28%), and irritable bowel syndrome (26%), according to the survey.

On the question of whether medications played a role in patients’ sexual dysfunction, nearly 15% of respondents said that prokinetic agents were involved, and 18% thought proton pump inhibitors affect sexual function. Both drug classes are considered responsible for sexual disturbances.

Few gastroenterologists prescribe phosphodiesterase type 5 inhibitors (PDE5i), e.g., Viagra, to treat sexual dysfunction, the survey found. Approximately 90% of respondents said that they never prescribed this class of drugs, preferring to refer patients to an andrologist. Of those who did prescribe PDE5i, significantly fewer residents did compared with experienced gastroenterologists (1.1% vs. 8.8%, respectively; P = .01).

Finally, the biggest reasons why gastroenterologists do not discuss sexual dysfunction are lack of knowledge (80%), insufficient experience (58%), time (44%), and embarrassment (30%).
 

Practice experience matters

There were some differences among respondents in the experienced group vs. the residents. More men were in the experienced group compared with residents (57.6% vs. 44%, respectively); mean age was 47 years vs. 29 years, respectively; and 71% had 5 or more years of experience in the experienced gastroenterologist group, whereas 78% had 1-5 years of experience among residents.

The survey found that more residents than experienced gastroenterologists “never discussed sexual dysfunction” (38.5% vs. 21.3%, respectively; P = .001) and that more residents than experienced gastroenterologists reported that “patients did not relate their sexual dysfunction to the prescribed therapy” (47.8% vs. 32.5%, respectively; P = .007).

The two groups varied regarding prescription drugs’ role in sexual dysfunction. More experienced gastroenterologists than residents felt that proton pump inhibitors (5.8% vs. 0%, respectively; P = .018) or prokinetics (19.8% vs. 9.5%, respectively; P = .028) might be responsible for some degree of sexual dysfunction.

More residents than experienced doctors felt that other (nongastroenterologic) drugs might contribute to sexual dysfunction in their patients (57.1% vs. 44.7%, respectively; P = .043).

Dr. Romano reported that fewer residents than experienced gastroenterologists referred male patients with sexual dysfunction to an andrologist (frequently/always: 28.1% vs. 44.4%, respectively; P = .004). However, more residents than experienced gastroenterologists disagreed that discussing sexual dysfunction with patients pertains only to specialists (andrologists and gynecologists; 83.5% vs. 71.2%, respectively; P = .018).
 

Time to step up

Asma Fikree, BMBCh, PhD, of Royal London Hospital, Barts Health NHS Trust, London, moderated the session. The survey highlights that asking patients about sexual dysfunction is an area for improvement for gastroenterologists, she said.

“We might do it in men and ask about erectile dysfunction, but we are very poor about asking in women,” Dr. Fikree noted.

The pros and cons of different medications should be discussed with patients, she said.

Gastroenterologists need to do a better job of considering how medications can lead to sexual dysfunction and interfere with quality of life, and training would help, she added.

“Some patients might not be very bothered by sexual dysfunction, but others might consider it very important,” Dr. Fikree said. “We should be considering this as part of their treatment and care.”

Dr. Romano and Dr. Fikree report no relevant financial relationships.

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

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Opioid use disorder (OUD) is a public health crisis significantly affecting veterans. A substantial increase in veterans diagnosed with OUD has occurred, nearly tripling from 25,031 in 2003 to 69,142 in 2017.¹ Furthermore, compared with civilians, veterans are twice as likely to die of an accidental overdose, most often from opioids.²

For patients with active OUD, medications for opioid use disorder (MOUD) reduce the risk of overdose and all-cause mortality.³ In 2009, the US Department of Veterans Affairs (VA) and Department of Defense (DoD) published clinical practice guidelines for substance use disorders that strongly recommended MOUD with either buprenorphine or methadone as a first-line treatment. In 2015 updated guidelines encouraged buprenorphine initiation in primary care settings.^4,5 This was followed by an academic detailing campaign designed to encourage VA clinicians to initiate MOUD.¹ Despite this institutional support, MOUD remains underutilized within the VA, with widely variable rates of prescribing among VA sites.¹

Efforts to further expand MOUD cultivated interest in administering buprenorphine in VA emergency departments (EDs). Patients with OUD often use the ED for same-day care, providing opportunities to initiate buprenorphine in the ED 24 hours, 7 days per week. This has been especially true during the COVID-19 pandemic during which reliable access to usual recovery services has been disrupted and EDs have served as a safety net.⁶

Buprenorphine’s safety profile and prolonged effect duration make it superior to other MOUD options for ED administration. As a partial opioid agonist, buprenorphine is unlikely to cause significant sedation or respiratory depression compared with full agonists like methadone. This is known as the ceiling effect. Additionally, at higher doses, buprenorphine’s effects can last for about 3 days, potentially obviating the need for repeat dosing. D’Onofrio and colleagues seminal 2015 paper conceptually proved the feasibility and value of initiating buprenorphine in the ED; patients who received ED initiation therapy were more likely to be engaged in addiction treatment 30 days after their visit and have reduced rates of illicit opioid drug use.⁷ Such ED harm-reduction strategies are increasingly recognized as essential, given that 1 in 20 patients treated for a nonfatal opioid overdose in an ED will die within 1 year of their visit, many within 2 days.⁸ Finally, a significant barrier faced by physicians wanting to administer or prescribe buprenorphine for patients with OUD has been the special licensing required by the Drug Enforcement Administration Drug Addiction Treatment Act of 2000, also known as an X-waiver. A notable exception to this X-waiver requirement is the 72-hour rule, which allows nonwaivered practitioners to administer (but not prescribe for home use) buprenorphine to a patient to relieve acute withdrawal symptoms for up to 72 hours while arranging for specialist referral.Under the 72-hour rule, ED clinicians have a unique opportunity to treat patients experiencing acute withdrawal symptoms and bridge them to specialty care, without the burden of an X-waiver requirement.

The VA Greater Los Angeles Healthcare System (VAGLAHS), therefore, developed and implemented a program to administer buprenorphine in the ED to bridge patients with OUD to an appointment with substance use disorder (SUD) services. We describe our development, implementation and evaluation of this program protocol as a model for other VA EDs. This project was determined to be quality improvement (nonresearch) by the VAGLAHS Institutional Review Board.

ED MOUD Program

We engaged in a 2-month (January-March 2019) preimplementation process during which we (1) obtained stakeholder buy-in; (2) developed a protocol and supporting resources and tools; (3) worked with stakeholders to enact local organizational policy and process modifications; and (4) educated practitioners. 

Appendix 1 provides an overview of MOUD terminology, pharmacology, and regulations. We developed an 8-step program implementation plan for the ED MOUD program (Figure 1).

Obtaining Stakeholder Buy-in

Two ED physician champions (MC, JH) organized all activities. Champions obtained stakeholder buy-in from clinical and administrative leaders as well as from frontline personnel in OUD specialty care, ED, and pharmacy services. ED social workers and clerks who schedule post-ED appointments also were engaged. These stakeholders emphasized the importance of fitting the developed protocol into the existing ED workflows as well as minimizing additional resources required to initiate and maintain the program.

We ascertained that in fiscal year 2018, VAGLAHS had 156 ED visits with International Statistical Classification of Diseases, Tenth Revision (ICD-10) codes related to OUD for 108 unique patients. Based on these data and in consultation with OUD specialty care, we determined that the potential number of referrals to the SUD clinic would be manageable with existing resources. Additionally, there was consensus that most opioid withdrawal patients could be treated in the urgent care portion of our ED since these patients generally do not require special monitoring. This consideration was important for obtaining ED stakeholder buy-in and for planning protocol logistics.

Developing the Protocol

We customized resources created by CalBridge Behavioral Health Navigator Program (CA Bridge), formerly called ED Bridge, a program of the Public Health Institute in Oakland, California, funded through California Department of Health Care Services. CA Bridge offers technical assistance and support for hospitals as well as guidance and tools for establishing processes for EDs providing buprenorphine prescriptions for the management of acute opioid withdrawal and serving as a bridge to follow-up care in SUD clinics.⁹ We also reviewed protocols described by D’Onofrio and colleagues. With iterative input from stakeholders, we created a protocol concretely delineating each process and corresponding responsible party with the overall aim of removing potential barriers to MOUD initiation and follow-up (Appendix 2).

Identifying Appropriate Follow-up

To operationalize protocol implementation, we built on VA’s Emergency Department Rapid Access Clinic (ED-RAC) process, a mechanism for scheduling appointments for post-ED specialty follow-up care. This process facilitated veterans’ access to urgent specialty care follow-up after ED visits by scheduling appointments prior to ED discharge.¹⁰ For the ED MOUD program, we adapted the ED-RAC process to schedule appointments in SUD clinic prior to ED discharge. These appointments allowed patients to be seen by an SUD clinician within 72 hours of ED discharge. This step was critical to working within the 72-hour rule without relying on X-waiver licensing of ED clinicians. Alternatively, as was previous practice, per patient preference, patients were also referred to non-VA residential rehabilitation services if the facility had capacity and patients met criteria for admission.

Identification of Eligible Veterans

Target patients were those primarily presenting with a request for treatment of opioid dependence or withdrawal. Patients were not actively screened for OUD. Clinicians diagnosed and assessed for OUD as per their usual practice. Patients with OUD who presented to the ED for other reasons were assessed, at clinician discretion, for their interest in receiving MOUD. If patients presented in moderate-to-severe withdrawal (eg, Clinical Opiate Withdrawal Scale [COWS] ≥ 8), buprenorphine was initiated in the ED. These patients were subsequently referred to either the local SUD clinic or to a residential treatment center. Patients presenting with a COWS score < 8 were referred to the outpatient SUD clinic or residential treatment centers without initiating buprenorphine from the ED. The SUD clinic or residential treatment centers could offer buprenorphine or other MOUD options. From the ED, prescribing buprenorphine for patients to self-initiate at home was not available as this required an X-waivered prescriber, which were limited during the program time frame.

Support Tools and Resources

To facilitate ED clinicians using the protocol, we worked with a programmer experienced with the Computerized Patient Record System, the VA electronic health record (EHR), to create electronic order menu sets that directed clinicians to the protocol and educational materials (Appendix 3). These menus are readily accessible and embedded into the ED clinician workflow. The menus highlight key elements of the protocol, including indications for initiation, contraindications, recommended dosing with quick orders, and how to obtain follow-up for the patient. Links also are provided to the protocol and patient discharge handouts, including the CA Bridge website.

Organizational Policy and Processes

Before implementing the developed protocol, we worked with stakeholders to modify organizational policies and processes. Our pharmacy agreed to stock buprenorphine in the ED to make it readily available. EHR restrictions that historically prohibited ordering buprenorphine for ED administration by nonwaivered clinicians were modified. Additionally, our chief of staff, pharmacy, and credentialing department agreed that physicians did not need to apply for additional delineated privileges.

Clinician Education

The final preparation step was educating clinicians and other protocol users. The VAGLAHS SUD chief presented a lecture and answered questions about MOUD to core ED faculty about the rising prevalence of OUD and use of buprenorphine as a recommended treatment.

Evaluation

To assess adherence to the developed protocol, we conducted a retrospective health record review of all ED visits March 1 to October 25, 2019, in which the patient had OUD and may have qualified for MOUD. To do this, we identified (1) ED visits with an OUD ICD-10 code as a primary or secondary diagnoses; (2) ED referrals to outpatient SUD treatment; and/or (3) ED visits in which buprenorphine was given or prescribed. We included the latter 2 criteria as application of ICD-10 codes for OUD care was inconsistent. Visits were excluded if patients did not have OUD, had OUD in remission, were already maintained on a stable MOUD regimen and no longer using illicit drugs or craving additional opioids, or were presenting solely for a refill or administration of a missed dose. Patients who relapsed were categorized as unstable. Visits were excluded if the patient was admitted to the hospital or left against medical advice. Patients on MOUD who had relapsed or requested a change in MOUD treatment were included. For all included visits, 2 ED physicians (MC, JH) reviewed the ED clinician and nursing notes, pharmacy and referral records, diagnostic codes, and veteran demographics.

In the evaluation, there were 130 visits with 92 unique veterans meeting inclusion criteria. The final sample included 70 visits with 47 unique veterans (Table 1). Of note, 24 (53%) patients self-identified as homeless or were engaged with VA housing services. Twelve veterans had multiple ED visits (7 patients with 2 visits; 5 patients with ≥ 3 visits). In 30 (43%) visits the veteran’s primary reason for seeking ED care was to obtain treatment for opioid withdrawal or receive MOUD. Type of opiate used was specified in 58% of visits; of these, 69% indicated heroin use and 17% prescription medications. Buprenorphine was initiated in the ED in 18 (26%) visits for 10 veterans. Appendix 4 outlines the clinical course and follow-up after these visits. Some veterans returned to the ED for buprenorphine redosing per the 72-hour rule. SUD clinic appointments were provided in 11 visits, and direct transfer to an inpatient rehabilitation center was arranged in 4 visits. In 42 (60%) visits, across 32 unique veterans, buprenorphine was not given in the ED, but patients were referred for SUD treatment (Table 2). In 10 (14%) visits, patients were not referred for SUD treatment or given buprenorphine, primarily because the presenting reason was not definitively related to OUDs.

DISCUSSION

We developed the ED MOUD program as a bridge to SUD specialty care. Our 8 implementation steps can serve as a model for implementing programs at other VA EDs. We demonstrated feasibility, high follow-up rates, and high retention in treatment.

Patients who received ED buprenorphine initiation were more likely to follow up and had higher rates of ongoing engagement at 30 days than did those who received only a clinic referral. In a similar Canadian study, buprenorphine was initiated in the ED, and patients followed up as a walk-in for addiction services; however, only 54% of patients presented to this initial follow-up.¹¹ Our higher initial follow-up rate may be due to our ability to directly schedule clinic appointments. Our 70% 30-day follow-up rate is comparable, but slightly lower than the 2015 D’Onofrio and colleagues study in which 78% of patients remained engaged at 30 days.⁷ A possible reason is that in the D’Onofrio and colleagues study, all study physicians obtained X-waiver training and were able to prescribe buprenorphine after ED initiation or for self-initiation at home. X-waiver training was not required of our clinicians, and none of our patients were offered a prescription for self-initiation.

Our program demonstrates that it is feasible to develop a protocol without X-waiver licensing. This program provides a supportive framework for the use of MOUD and allows nonspecialists to gain experience and confidence in using buprenorphine. Any clinician could administer buprenorphine in the ED, and patients could be bridged at later ED visits until follow-up with a specialist. Of note, only a small percentage of the total visits for buprenorphine initiation required multiple daily visits for buprenorphine. Appointments with the specialist were assured to fall within a 72-hour window.

Our program has some limitations. First, the number of patients who were candidates for our ED MOUD program was small. In our 7-month review, only 47 patients were identified as potential candidates for MOUD treatment across 70 visits, and only 10 were initiated in the ED. Second, all patients were not actively screened for OUD. There was potential for missing eligible veterans as inclusion criteria relied on clinicians both recognizing OUD and manually entering a correct diagnostic code. We attempted to mitigate this by also reviewing all ED referrals to the SUD clinic and all patients who received buprenorphine in the ED. In addition, we do not have data on preimplementation rates of follow-up for comparison.

Future Directions

More than half of our patients did not receive ED buprenorphine initiation because they were not in moderate or severe withdrawal (COWS ≥ 8) similar to 57% of patients cited in the D’Onofrio and colleagues study.⁷ Teaching veterans how to start buprenorphine at home could greatly expand enrollment. However, this requires a prescription from an X-waiver licensed clinician. In 2021, the US Department of Health and Human Services removed the 8-hour training requirement for obtaining an X-waiver.¹² However, clinicians are still required to apply for licensing. Eliminating the X-waiver requirement, as proposed by D’Onofrio and colleagues in a 2021 editorial, would have allowed all clinicians to offer home initiation.¹³

Previous studies suggest that despite the ability to provide a prescription, clinicians may be reluctant to offer home initiation.^14–17 In a national VA 2019 survey, many emergency medicine physicians believe that SUD care is not in their scope of practice, as Dieujuste and colleagues described in Federal Practitioner.¹⁴ Although it is likely some attitudes have changed with the increased visibility of ED MOUD programs, there is still much work to be done to change perceptions.

Another area for improvement is screening for OUD in the ED to better reveal MOUD candidates. Missed opportunities (neither referral nor treatment offered) occurred in 21% of our visits. D’Onofrio and colleagues identified 66% of patients by screening all ED patients.⁷ Although universal screening for SUD in routine health care settings has been recommended, 2021 VA guidelines state that there is insufficient evidence to recommend universal screening.^18-20 There are also limited data on the best screening tool for OUD in the ED.²¹ Further research on how to effectively and efficiently identify OUD patients in the ED is needed.

Conclusions

With minimal resource allocation, we started the program to offer MOUD with buprenorphine for patients with OUD at a VA ED and provided addiction treatment follow-up. This program, the first of its kind within VA, can be modeled and expanded to other VA facilities. Given increasing numbers of fatal opioid overdose, and significant adverse impacts of the COVID-19 pandemic on the OUD crisis, developing local and national strategies to treat OUD is essential. Future steps include improved screening and expanding capacity to offer home initiation by increasing the number of X-waiver ED clinicians.⁶

Acknowledgments

Thank you to Jeffrey Balsam, PharmD, BCPS, Veterans Affairs Greater Los Angeles Clinical Applications Coordinator for his contributions in creating a Computerized Patient Record System opioid use disorder screening tool. Thank you to Gracielle Tan, MD, Veterans Affairs Greater Los Angeles Health Science Specialist for her administrative assistance in manuscript preparation.

Opioid use disorder (OUD) is a public health crisis significantly affecting veterans. A substantial increase in veterans diagnosed with OUD has occurred, nearly tripling from 25,031 in 2003 to 69,142 in 2017.¹ Furthermore, compared with civilians, veterans are twice as likely to die of an accidental overdose, most often from opioids.²

For patients with active OUD, medications for opioid use disorder (MOUD) reduce the risk of overdose and all-cause mortality.³ In 2009, the US Department of Veterans Affairs (VA) and Department of Defense (DoD) published clinical practice guidelines for substance use disorders that strongly recommended MOUD with either buprenorphine or methadone as a first-line treatment. In 2015 updated guidelines encouraged buprenorphine initiation in primary care settings.^4,5 This was followed by an academic detailing campaign designed to encourage VA clinicians to initiate MOUD.¹ Despite this institutional support, MOUD remains underutilized within the VA, with widely variable rates of prescribing among VA sites.¹

Efforts to further expand MOUD cultivated interest in administering buprenorphine in VA emergency departments (EDs). Patients with OUD often use the ED for same-day care, providing opportunities to initiate buprenorphine in the ED 24 hours, 7 days per week. This has been especially true during the COVID-19 pandemic during which reliable access to usual recovery services has been disrupted and EDs have served as a safety net.⁶

Buprenorphine’s safety profile and prolonged effect duration make it superior to other MOUD options for ED administration. As a partial opioid agonist, buprenorphine is unlikely to cause significant sedation or respiratory depression compared with full agonists like methadone. This is known as the ceiling effect. Additionally, at higher doses, buprenorphine’s effects can last for about 3 days, potentially obviating the need for repeat dosing. D’Onofrio and colleagues seminal 2015 paper conceptually proved the feasibility and value of initiating buprenorphine in the ED; patients who received ED initiation therapy were more likely to be engaged in addiction treatment 30 days after their visit and have reduced rates of illicit opioid drug use.⁷ Such ED harm-reduction strategies are increasingly recognized as essential, given that 1 in 20 patients treated for a nonfatal opioid overdose in an ED will die within 1 year of their visit, many within 2 days.⁸ Finally, a significant barrier faced by physicians wanting to administer or prescribe buprenorphine for patients with OUD has been the special licensing required by the Drug Enforcement Administration Drug Addiction Treatment Act of 2000, also known as an X-waiver. A notable exception to this X-waiver requirement is the 72-hour rule, which allows nonwaivered practitioners to administer (but not prescribe for home use) buprenorphine to a patient to relieve acute withdrawal symptoms for up to 72 hours while arranging for specialist referral.Under the 72-hour rule, ED clinicians have a unique opportunity to treat patients experiencing acute withdrawal symptoms and bridge them to specialty care, without the burden of an X-waiver requirement.

The VA Greater Los Angeles Healthcare System (VAGLAHS), therefore, developed and implemented a program to administer buprenorphine in the ED to bridge patients with OUD to an appointment with substance use disorder (SUD) services. We describe our development, implementation and evaluation of this program protocol as a model for other VA EDs. This project was determined to be quality improvement (nonresearch) by the VAGLAHS Institutional Review Board.

ED MOUD Program

We engaged in a 2-month (January-March 2019) preimplementation process during which we (1) obtained stakeholder buy-in; (2) developed a protocol and supporting resources and tools; (3) worked with stakeholders to enact local organizational policy and process modifications; and (4) educated practitioners. 

Appendix 1 provides an overview of MOUD terminology, pharmacology, and regulations. We developed an 8-step program implementation plan for the ED MOUD program (Figure 1).

Obtaining Stakeholder Buy-in

Two ED physician champions (MC, JH) organized all activities. Champions obtained stakeholder buy-in from clinical and administrative leaders as well as from frontline personnel in OUD specialty care, ED, and pharmacy services. ED social workers and clerks who schedule post-ED appointments also were engaged. These stakeholders emphasized the importance of fitting the developed protocol into the existing ED workflows as well as minimizing additional resources required to initiate and maintain the program.

We ascertained that in fiscal year 2018, VAGLAHS had 156 ED visits with International Statistical Classification of Diseases, Tenth Revision (ICD-10) codes related to OUD for 108 unique patients. Based on these data and in consultation with OUD specialty care, we determined that the potential number of referrals to the SUD clinic would be manageable with existing resources. Additionally, there was consensus that most opioid withdrawal patients could be treated in the urgent care portion of our ED since these patients generally do not require special monitoring. This consideration was important for obtaining ED stakeholder buy-in and for planning protocol logistics.

Developing the Protocol

We customized resources created by CalBridge Behavioral Health Navigator Program (CA Bridge), formerly called ED Bridge, a program of the Public Health Institute in Oakland, California, funded through California Department of Health Care Services. CA Bridge offers technical assistance and support for hospitals as well as guidance and tools for establishing processes for EDs providing buprenorphine prescriptions for the management of acute opioid withdrawal and serving as a bridge to follow-up care in SUD clinics.⁹ We also reviewed protocols described by D’Onofrio and colleagues. With iterative input from stakeholders, we created a protocol concretely delineating each process and corresponding responsible party with the overall aim of removing potential barriers to MOUD initiation and follow-up (Appendix 2).

Identifying Appropriate Follow-up

To operationalize protocol implementation, we built on VA’s Emergency Department Rapid Access Clinic (ED-RAC) process, a mechanism for scheduling appointments for post-ED specialty follow-up care. This process facilitated veterans’ access to urgent specialty care follow-up after ED visits by scheduling appointments prior to ED discharge.¹⁰ For the ED MOUD program, we adapted the ED-RAC process to schedule appointments in SUD clinic prior to ED discharge. These appointments allowed patients to be seen by an SUD clinician within 72 hours of ED discharge. This step was critical to working within the 72-hour rule without relying on X-waiver licensing of ED clinicians. Alternatively, as was previous practice, per patient preference, patients were also referred to non-VA residential rehabilitation services if the facility had capacity and patients met criteria for admission.

Identification of Eligible Veterans

Target patients were those primarily presenting with a request for treatment of opioid dependence or withdrawal. Patients were not actively screened for OUD. Clinicians diagnosed and assessed for OUD as per their usual practice. Patients with OUD who presented to the ED for other reasons were assessed, at clinician discretion, for their interest in receiving MOUD. If patients presented in moderate-to-severe withdrawal (eg, Clinical Opiate Withdrawal Scale [COWS] ≥ 8), buprenorphine was initiated in the ED. These patients were subsequently referred to either the local SUD clinic or to a residential treatment center. Patients presenting with a COWS score < 8 were referred to the outpatient SUD clinic or residential treatment centers without initiating buprenorphine from the ED. The SUD clinic or residential treatment centers could offer buprenorphine or other MOUD options. From the ED, prescribing buprenorphine for patients to self-initiate at home was not available as this required an X-waivered prescriber, which were limited during the program time frame.

Support Tools and Resources

To facilitate ED clinicians using the protocol, we worked with a programmer experienced with the Computerized Patient Record System, the VA electronic health record (EHR), to create electronic order menu sets that directed clinicians to the protocol and educational materials (Appendix 3). These menus are readily accessible and embedded into the ED clinician workflow. The menus highlight key elements of the protocol, including indications for initiation, contraindications, recommended dosing with quick orders, and how to obtain follow-up for the patient. Links also are provided to the protocol and patient discharge handouts, including the CA Bridge website.

Organizational Policy and Processes

Before implementing the developed protocol, we worked with stakeholders to modify organizational policies and processes. Our pharmacy agreed to stock buprenorphine in the ED to make it readily available. EHR restrictions that historically prohibited ordering buprenorphine for ED administration by nonwaivered clinicians were modified. Additionally, our chief of staff, pharmacy, and credentialing department agreed that physicians did not need to apply for additional delineated privileges.

Clinician Education

The final preparation step was educating clinicians and other protocol users. The VAGLAHS SUD chief presented a lecture and answered questions about MOUD to core ED faculty about the rising prevalence of OUD and use of buprenorphine as a recommended treatment.

Evaluation

To assess adherence to the developed protocol, we conducted a retrospective health record review of all ED visits March 1 to October 25, 2019, in which the patient had OUD and may have qualified for MOUD. To do this, we identified (1) ED visits with an OUD ICD-10 code as a primary or secondary diagnoses; (2) ED referrals to outpatient SUD treatment; and/or (3) ED visits in which buprenorphine was given or prescribed. We included the latter 2 criteria as application of ICD-10 codes for OUD care was inconsistent. Visits were excluded if patients did not have OUD, had OUD in remission, were already maintained on a stable MOUD regimen and no longer using illicit drugs or craving additional opioids, or were presenting solely for a refill or administration of a missed dose. Patients who relapsed were categorized as unstable. Visits were excluded if the patient was admitted to the hospital or left against medical advice. Patients on MOUD who had relapsed or requested a change in MOUD treatment were included. For all included visits, 2 ED physicians (MC, JH) reviewed the ED clinician and nursing notes, pharmacy and referral records, diagnostic codes, and veteran demographics.

In the evaluation, there were 130 visits with 92 unique veterans meeting inclusion criteria. The final sample included 70 visits with 47 unique veterans (Table 1). Of note, 24 (53%) patients self-identified as homeless or were engaged with VA housing services. Twelve veterans had multiple ED visits (7 patients with 2 visits; 5 patients with ≥ 3 visits). In 30 (43%) visits the veteran’s primary reason for seeking ED care was to obtain treatment for opioid withdrawal or receive MOUD. Type of opiate used was specified in 58% of visits; of these, 69% indicated heroin use and 17% prescription medications. Buprenorphine was initiated in the ED in 18 (26%) visits for 10 veterans. Appendix 4 outlines the clinical course and follow-up after these visits. Some veterans returned to the ED for buprenorphine redosing per the 72-hour rule. SUD clinic appointments were provided in 11 visits, and direct transfer to an inpatient rehabilitation center was arranged in 4 visits. In 42 (60%) visits, across 32 unique veterans, buprenorphine was not given in the ED, but patients were referred for SUD treatment (Table 2). In 10 (14%) visits, patients were not referred for SUD treatment or given buprenorphine, primarily because the presenting reason was not definitively related to OUDs.

DISCUSSION

We developed the ED MOUD program as a bridge to SUD specialty care. Our 8 implementation steps can serve as a model for implementing programs at other VA EDs. We demonstrated feasibility, high follow-up rates, and high retention in treatment.

Patients who received ED buprenorphine initiation were more likely to follow up and had higher rates of ongoing engagement at 30 days than did those who received only a clinic referral. In a similar Canadian study, buprenorphine was initiated in the ED, and patients followed up as a walk-in for addiction services; however, only 54% of patients presented to this initial follow-up.¹¹ Our higher initial follow-up rate may be due to our ability to directly schedule clinic appointments. Our 70% 30-day follow-up rate is comparable, but slightly lower than the 2015 D’Onofrio and colleagues study in which 78% of patients remained engaged at 30 days.⁷ A possible reason is that in the D’Onofrio and colleagues study, all study physicians obtained X-waiver training and were able to prescribe buprenorphine after ED initiation or for self-initiation at home. X-waiver training was not required of our clinicians, and none of our patients were offered a prescription for self-initiation.

Our program demonstrates that it is feasible to develop a protocol without X-waiver licensing. This program provides a supportive framework for the use of MOUD and allows nonspecialists to gain experience and confidence in using buprenorphine. Any clinician could administer buprenorphine in the ED, and patients could be bridged at later ED visits until follow-up with a specialist. Of note, only a small percentage of the total visits for buprenorphine initiation required multiple daily visits for buprenorphine. Appointments with the specialist were assured to fall within a 72-hour window.

Our program has some limitations. First, the number of patients who were candidates for our ED MOUD program was small. In our 7-month review, only 47 patients were identified as potential candidates for MOUD treatment across 70 visits, and only 10 were initiated in the ED. Second, all patients were not actively screened for OUD. There was potential for missing eligible veterans as inclusion criteria relied on clinicians both recognizing OUD and manually entering a correct diagnostic code. We attempted to mitigate this by also reviewing all ED referrals to the SUD clinic and all patients who received buprenorphine in the ED. In addition, we do not have data on preimplementation rates of follow-up for comparison.

Future Directions

More than half of our patients did not receive ED buprenorphine initiation because they were not in moderate or severe withdrawal (COWS ≥ 8) similar to 57% of patients cited in the D’Onofrio and colleagues study.⁷ Teaching veterans how to start buprenorphine at home could greatly expand enrollment. However, this requires a prescription from an X-waiver licensed clinician. In 2021, the US Department of Health and Human Services removed the 8-hour training requirement for obtaining an X-waiver.¹² However, clinicians are still required to apply for licensing. Eliminating the X-waiver requirement, as proposed by D’Onofrio and colleagues in a 2021 editorial, would have allowed all clinicians to offer home initiation.¹³

Previous studies suggest that despite the ability to provide a prescription, clinicians may be reluctant to offer home initiation.^14–17 In a national VA 2019 survey, many emergency medicine physicians believe that SUD care is not in their scope of practice, as Dieujuste and colleagues described in Federal Practitioner.¹⁴ Although it is likely some attitudes have changed with the increased visibility of ED MOUD programs, there is still much work to be done to change perceptions.

Another area for improvement is screening for OUD in the ED to better reveal MOUD candidates. Missed opportunities (neither referral nor treatment offered) occurred in 21% of our visits. D’Onofrio and colleagues identified 66% of patients by screening all ED patients.⁷ Although universal screening for SUD in routine health care settings has been recommended, 2021 VA guidelines state that there is insufficient evidence to recommend universal screening.^18-20 There are also limited data on the best screening tool for OUD in the ED.²¹ Further research on how to effectively and efficiently identify OUD patients in the ED is needed.

Conclusions

With minimal resource allocation, we started the program to offer MOUD with buprenorphine for patients with OUD at a VA ED and provided addiction treatment follow-up. This program, the first of its kind within VA, can be modeled and expanded to other VA facilities. Given increasing numbers of fatal opioid overdose, and significant adverse impacts of the COVID-19 pandemic on the OUD crisis, developing local and national strategies to treat OUD is essential. Future steps include improved screening and expanding capacity to offer home initiation by increasing the number of X-waiver ED clinicians.⁶

Acknowledgments

Thank you to Jeffrey Balsam, PharmD, BCPS, Veterans Affairs Greater Los Angeles Clinical Applications Coordinator for his contributions in creating a Computerized Patient Record System opioid use disorder screening tool. Thank you to Gracielle Tan, MD, Veterans Affairs Greater Los Angeles Health Science Specialist for her administrative assistance in manuscript preparation.

Opioid use disorder (OUD) is a public health crisis significantly affecting veterans. A substantial increase in veterans diagnosed with OUD has occurred, nearly tripling from 25,031 in 2003 to 69,142 in 2017.¹ Furthermore, compared with civilians, veterans are twice as likely to die of an accidental overdose, most often from opioids.²

For patients with active OUD, medications for opioid use disorder (MOUD) reduce the risk of overdose and all-cause mortality.³ In 2009, the US Department of Veterans Affairs (VA) and Department of Defense (DoD) published clinical practice guidelines for substance use disorders that strongly recommended MOUD with either buprenorphine or methadone as a first-line treatment. In 2015 updated guidelines encouraged buprenorphine initiation in primary care settings.^4,5 This was followed by an academic detailing campaign designed to encourage VA clinicians to initiate MOUD.¹ Despite this institutional support, MOUD remains underutilized within the VA, with widely variable rates of prescribing among VA sites.¹

Efforts to further expand MOUD cultivated interest in administering buprenorphine in VA emergency departments (EDs). Patients with OUD often use the ED for same-day care, providing opportunities to initiate buprenorphine in the ED 24 hours, 7 days per week. This has been especially true during the COVID-19 pandemic during which reliable access to usual recovery services has been disrupted and EDs have served as a safety net.⁶

Buprenorphine’s safety profile and prolonged effect duration make it superior to other MOUD options for ED administration. As a partial opioid agonist, buprenorphine is unlikely to cause significant sedation or respiratory depression compared with full agonists like methadone. This is known as the ceiling effect. Additionally, at higher doses, buprenorphine’s effects can last for about 3 days, potentially obviating the need for repeat dosing. D’Onofrio and colleagues seminal 2015 paper conceptually proved the feasibility and value of initiating buprenorphine in the ED; patients who received ED initiation therapy were more likely to be engaged in addiction treatment 30 days after their visit and have reduced rates of illicit opioid drug use.⁷ Such ED harm-reduction strategies are increasingly recognized as essential, given that 1 in 20 patients treated for a nonfatal opioid overdose in an ED will die within 1 year of their visit, many within 2 days.⁸ Finally, a significant barrier faced by physicians wanting to administer or prescribe buprenorphine for patients with OUD has been the special licensing required by the Drug Enforcement Administration Drug Addiction Treatment Act of 2000, also known as an X-waiver. A notable exception to this X-waiver requirement is the 72-hour rule, which allows nonwaivered practitioners to administer (but not prescribe for home use) buprenorphine to a patient to relieve acute withdrawal symptoms for up to 72 hours while arranging for specialist referral.Under the 72-hour rule, ED clinicians have a unique opportunity to treat patients experiencing acute withdrawal symptoms and bridge them to specialty care, without the burden of an X-waiver requirement.

The VA Greater Los Angeles Healthcare System (VAGLAHS), therefore, developed and implemented a program to administer buprenorphine in the ED to bridge patients with OUD to an appointment with substance use disorder (SUD) services. We describe our development, implementation and evaluation of this program protocol as a model for other VA EDs. This project was determined to be quality improvement (nonresearch) by the VAGLAHS Institutional Review Board.

ED MOUD Program

We engaged in a 2-month (January-March 2019) preimplementation process during which we (1) obtained stakeholder buy-in; (2) developed a protocol and supporting resources and tools; (3) worked with stakeholders to enact local organizational policy and process modifications; and (4) educated practitioners. 

Appendix 1 provides an overview of MOUD terminology, pharmacology, and regulations. We developed an 8-step program implementation plan for the ED MOUD program (Figure 1).

Obtaining Stakeholder Buy-in

Two ED physician champions (MC, JH) organized all activities. Champions obtained stakeholder buy-in from clinical and administrative leaders as well as from frontline personnel in OUD specialty care, ED, and pharmacy services. ED social workers and clerks who schedule post-ED appointments also were engaged. These stakeholders emphasized the importance of fitting the developed protocol into the existing ED workflows as well as minimizing additional resources required to initiate and maintain the program.

We ascertained that in fiscal year 2018, VAGLAHS had 156 ED visits with International Statistical Classification of Diseases, Tenth Revision (ICD-10) codes related to OUD for 108 unique patients. Based on these data and in consultation with OUD specialty care, we determined that the potential number of referrals to the SUD clinic would be manageable with existing resources. Additionally, there was consensus that most opioid withdrawal patients could be treated in the urgent care portion of our ED since these patients generally do not require special monitoring. This consideration was important for obtaining ED stakeholder buy-in and for planning protocol logistics.

Developing the Protocol

We customized resources created by CalBridge Behavioral Health Navigator Program (CA Bridge), formerly called ED Bridge, a program of the Public Health Institute in Oakland, California, funded through California Department of Health Care Services. CA Bridge offers technical assistance and support for hospitals as well as guidance and tools for establishing processes for EDs providing buprenorphine prescriptions for the management of acute opioid withdrawal and serving as a bridge to follow-up care in SUD clinics.⁹ We also reviewed protocols described by D’Onofrio and colleagues. With iterative input from stakeholders, we created a protocol concretely delineating each process and corresponding responsible party with the overall aim of removing potential barriers to MOUD initiation and follow-up (Appendix 2).

Identifying Appropriate Follow-up

To operationalize protocol implementation, we built on VA’s Emergency Department Rapid Access Clinic (ED-RAC) process, a mechanism for scheduling appointments for post-ED specialty follow-up care. This process facilitated veterans’ access to urgent specialty care follow-up after ED visits by scheduling appointments prior to ED discharge.¹⁰ For the ED MOUD program, we adapted the ED-RAC process to schedule appointments in SUD clinic prior to ED discharge. These appointments allowed patients to be seen by an SUD clinician within 72 hours of ED discharge. This step was critical to working within the 72-hour rule without relying on X-waiver licensing of ED clinicians. Alternatively, as was previous practice, per patient preference, patients were also referred to non-VA residential rehabilitation services if the facility had capacity and patients met criteria for admission.

Identification of Eligible Veterans

Target patients were those primarily presenting with a request for treatment of opioid dependence or withdrawal. Patients were not actively screened for OUD. Clinicians diagnosed and assessed for OUD as per their usual practice. Patients with OUD who presented to the ED for other reasons were assessed, at clinician discretion, for their interest in receiving MOUD. If patients presented in moderate-to-severe withdrawal (eg, Clinical Opiate Withdrawal Scale [COWS] ≥ 8), buprenorphine was initiated in the ED. These patients were subsequently referred to either the local SUD clinic or to a residential treatment center. Patients presenting with a COWS score < 8 were referred to the outpatient SUD clinic or residential treatment centers without initiating buprenorphine from the ED. The SUD clinic or residential treatment centers could offer buprenorphine or other MOUD options. From the ED, prescribing buprenorphine for patients to self-initiate at home was not available as this required an X-waivered prescriber, which were limited during the program time frame.

Support Tools and Resources

To facilitate ED clinicians using the protocol, we worked with a programmer experienced with the Computerized Patient Record System, the VA electronic health record (EHR), to create electronic order menu sets that directed clinicians to the protocol and educational materials (Appendix 3). These menus are readily accessible and embedded into the ED clinician workflow. The menus highlight key elements of the protocol, including indications for initiation, contraindications, recommended dosing with quick orders, and how to obtain follow-up for the patient. Links also are provided to the protocol and patient discharge handouts, including the CA Bridge website.

Organizational Policy and Processes

Before implementing the developed protocol, we worked with stakeholders to modify organizational policies and processes. Our pharmacy agreed to stock buprenorphine in the ED to make it readily available. EHR restrictions that historically prohibited ordering buprenorphine for ED administration by nonwaivered clinicians were modified. Additionally, our chief of staff, pharmacy, and credentialing department agreed that physicians did not need to apply for additional delineated privileges.

Clinician Education

The final preparation step was educating clinicians and other protocol users. The VAGLAHS SUD chief presented a lecture and answered questions about MOUD to core ED faculty about the rising prevalence of OUD and use of buprenorphine as a recommended treatment.

Evaluation

To assess adherence to the developed protocol, we conducted a retrospective health record review of all ED visits March 1 to October 25, 2019, in which the patient had OUD and may have qualified for MOUD. To do this, we identified (1) ED visits with an OUD ICD-10 code as a primary or secondary diagnoses; (2) ED referrals to outpatient SUD treatment; and/or (3) ED visits in which buprenorphine was given or prescribed. We included the latter 2 criteria as application of ICD-10 codes for OUD care was inconsistent. Visits were excluded if patients did not have OUD, had OUD in remission, were already maintained on a stable MOUD regimen and no longer using illicit drugs or craving additional opioids, or were presenting solely for a refill or administration of a missed dose. Patients who relapsed were categorized as unstable. Visits were excluded if the patient was admitted to the hospital or left against medical advice. Patients on MOUD who had relapsed or requested a change in MOUD treatment were included. For all included visits, 2 ED physicians (MC, JH) reviewed the ED clinician and nursing notes, pharmacy and referral records, diagnostic codes, and veteran demographics.

In the evaluation, there were 130 visits with 92 unique veterans meeting inclusion criteria. The final sample included 70 visits with 47 unique veterans (Table 1). Of note, 24 (53%) patients self-identified as homeless or were engaged with VA housing services. Twelve veterans had multiple ED visits (7 patients with 2 visits; 5 patients with ≥ 3 visits). In 30 (43%) visits the veteran’s primary reason for seeking ED care was to obtain treatment for opioid withdrawal or receive MOUD. Type of opiate used was specified in 58% of visits; of these, 69% indicated heroin use and 17% prescription medications. Buprenorphine was initiated in the ED in 18 (26%) visits for 10 veterans. Appendix 4 outlines the clinical course and follow-up after these visits. Some veterans returned to the ED for buprenorphine redosing per the 72-hour rule. SUD clinic appointments were provided in 11 visits, and direct transfer to an inpatient rehabilitation center was arranged in 4 visits. In 42 (60%) visits, across 32 unique veterans, buprenorphine was not given in the ED, but patients were referred for SUD treatment (Table 2). In 10 (14%) visits, patients were not referred for SUD treatment or given buprenorphine, primarily because the presenting reason was not definitively related to OUDs.

DISCUSSION

We developed the ED MOUD program as a bridge to SUD specialty care. Our 8 implementation steps can serve as a model for implementing programs at other VA EDs. We demonstrated feasibility, high follow-up rates, and high retention in treatment.

Patients who received ED buprenorphine initiation were more likely to follow up and had higher rates of ongoing engagement at 30 days than did those who received only a clinic referral. In a similar Canadian study, buprenorphine was initiated in the ED, and patients followed up as a walk-in for addiction services; however, only 54% of patients presented to this initial follow-up.¹¹ Our higher initial follow-up rate may be due to our ability to directly schedule clinic appointments. Our 70% 30-day follow-up rate is comparable, but slightly lower than the 2015 D’Onofrio and colleagues study in which 78% of patients remained engaged at 30 days.⁷ A possible reason is that in the D’Onofrio and colleagues study, all study physicians obtained X-waiver training and were able to prescribe buprenorphine after ED initiation or for self-initiation at home. X-waiver training was not required of our clinicians, and none of our patients were offered a prescription for self-initiation.

Our program demonstrates that it is feasible to develop a protocol without X-waiver licensing. This program provides a supportive framework for the use of MOUD and allows nonspecialists to gain experience and confidence in using buprenorphine. Any clinician could administer buprenorphine in the ED, and patients could be bridged at later ED visits until follow-up with a specialist. Of note, only a small percentage of the total visits for buprenorphine initiation required multiple daily visits for buprenorphine. Appointments with the specialist were assured to fall within a 72-hour window.

Our program has some limitations. First, the number of patients who were candidates for our ED MOUD program was small. In our 7-month review, only 47 patients were identified as potential candidates for MOUD treatment across 70 visits, and only 10 were initiated in the ED. Second, all patients were not actively screened for OUD. There was potential for missing eligible veterans as inclusion criteria relied on clinicians both recognizing OUD and manually entering a correct diagnostic code. We attempted to mitigate this by also reviewing all ED referrals to the SUD clinic and all patients who received buprenorphine in the ED. In addition, we do not have data on preimplementation rates of follow-up for comparison.

Future Directions

More than half of our patients did not receive ED buprenorphine initiation because they were not in moderate or severe withdrawal (COWS ≥ 8) similar to 57% of patients cited in the D’Onofrio and colleagues study.⁷ Teaching veterans how to start buprenorphine at home could greatly expand enrollment. However, this requires a prescription from an X-waiver licensed clinician. In 2021, the US Department of Health and Human Services removed the 8-hour training requirement for obtaining an X-waiver.¹² However, clinicians are still required to apply for licensing. Eliminating the X-waiver requirement, as proposed by D’Onofrio and colleagues in a 2021 editorial, would have allowed all clinicians to offer home initiation.¹³

Previous studies suggest that despite the ability to provide a prescription, clinicians may be reluctant to offer home initiation.^14–17 In a national VA 2019 survey, many emergency medicine physicians believe that SUD care is not in their scope of practice, as Dieujuste and colleagues described in Federal Practitioner.¹⁴ Although it is likely some attitudes have changed with the increased visibility of ED MOUD programs, there is still much work to be done to change perceptions.

Another area for improvement is screening for OUD in the ED to better reveal MOUD candidates. Missed opportunities (neither referral nor treatment offered) occurred in 21% of our visits. D’Onofrio and colleagues identified 66% of patients by screening all ED patients.⁷ Although universal screening for SUD in routine health care settings has been recommended, 2021 VA guidelines state that there is insufficient evidence to recommend universal screening.^18-20 There are also limited data on the best screening tool for OUD in the ED.²¹ Further research on how to effectively and efficiently identify OUD patients in the ED is needed.

Conclusions

With minimal resource allocation, we started the program to offer MOUD with buprenorphine for patients with OUD at a VA ED and provided addiction treatment follow-up. This program, the first of its kind within VA, can be modeled and expanded to other VA facilities. Given increasing numbers of fatal opioid overdose, and significant adverse impacts of the COVID-19 pandemic on the OUD crisis, developing local and national strategies to treat OUD is essential. Future steps include improved screening and expanding capacity to offer home initiation by increasing the number of X-waiver ED clinicians.⁶

Acknowledgments

Thank you to Jeffrey Balsam, PharmD, BCPS, Veterans Affairs Greater Los Angeles Clinical Applications Coordinator for his contributions in creating a Computerized Patient Record System opioid use disorder screening tool. Thank you to Gracielle Tan, MD, Veterans Affairs Greater Los Angeles Health Science Specialist for her administrative assistance in manuscript preparation.

The drug fezolinetant, a selective neurokinin-3 receptor antagonist under investigation for treatment of menopausal vasomotor symptoms, showed acceptable long-term safety and tolerability during a 1-year phase 3 randomized controlled trial, according to data presented at the annual meeting of the North American Menopause Society. The study, called SKYLIGHT 4, examined fezolinetant treatment, especially in terms of endometrial health.

The findings mean that fezolinetant “may help bridge a gap in the management of vasomotor symptoms,” according to lead author Genevieve Neal-Perry, MD, PhD, chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

This study was an important step in fezolinetant’s path toward potential approval by the Food and Drug Administration for vasomotor symptoms.

”Moderate and severe vasomotor symptoms can adversely affect quality of life of those affected and result in sleep disruption as well as increased risk for heart disease and other high-risk medical problems,” Dr. Neal-Perry said. “Although menopausal hormone therapy significantly improves vasomotor symptoms, it may not be desired or it may not be safe for some women,” resulting in gaps in care and a need for targeted, nonhormonal therapies for hot flashes. A planned study will also assess the safety of the drug in patients with a diagnosis of hormone-sensitive cancer and disorders that increase the risk for blood clots.

”Fezolinetant has a low side effect profile, it is a nonhormonal option, and it is selective for the neurons that trigger and mediate hot flashes,” Dr. Neal-Perry said.

Hot flashes are caused by kisspeptin, neurokinin B, and dynorphin neurons located in the hypothalamus. Fezolinetant works by selectively blocking the neurokinin 3 receptor (NK3R), which regulates a person’s sense of temperature, Dr. Neal-Perry explained. Overactivation of NK3R, resulting from low estrogen levels, plays a role in the hot flashes and cold sweats women experience during menopause.

Drug development for hot flashes ”has been hampered by a lack of knowledge regarding the biological cause,” Dr. Neal-Perry said. “Now that we have a robust understanding of the basic biology of hot flashes, we can develop novel, highly effective, and targeted therapy.”

This safety study involved 1,830 women, ages 40-65, who were experiencing menopausal vasomotor symptoms and were randomly assigned to one of three arms for 52 weeks: 45 mg of fezolinetant, 30 mg of fezolinetant, or a placebo once daily.

The primary endpoints included the percentage of women with endometrial hyperplasia, the percentage of women with endometrial cancer, and the frequency and severity of treatment-emergent adverse events (TEAEs). To meet the primary safety endpoint, no more than 1% of participants could have hyperplasia or malignancy, with an upper confidence interval boundary not greater than 4%. Women who met prespecified criteria for their endometrial health to be assessed, underwent endometrial biopsies at baseline and at the end of the study. Three independent pathologists analyzed the tissue without knowledge of which study arm each sample came from. Among the 599 endometrial biopsy samples, 0.5% of the 203 participants taking 45 mg fezolinetant had hyperplasia while none of the women in the other two arms did. Among the 210 women taking 30 mg of fezolinetant, 0.5% had a malignancy; no malignancies occurred in the other two arms.

Overall adverse events were similar across all three arms, including rates of adverse events leading to discontinuation. The most common adverse events were headache and COVID-19. TEAEs related to the drug were 18.1% in the 45-mg arm, 15.4% in the 30-mg arm, and 17.4% in the placebo arm. Serious adverse events were similar across all three arms, and only 0.5% of participants in the 45-mg arm experienced drug-related serious adverse events, compared with none of the women in the 30-mg arm and 0.2% of women in the placebo group.

”The frequency of transaminase elevations was low, and these TEAEs were generally isolated, transient, and resolved on treatment or with discontinuation,” the authors reported.

The next steps for fezolinetant will be to assess its effect on mood and quality of life measures related to vasomotor symptoms, Dr. Neal-Perry said.

Samantha Dunham, MD, a NAMS-certified menopause practitioner and an associate professor of obstetrics and gynecology at New York University, suggested the drug’s safety in the study is encouraging.

”As a medication that treats menopausal symptoms, the study confirmed there are no issues with the endometrium, or lining of the uterus, not that one would expect issues given the mechanism of action,” Dr. Dunham, also codirector of NYU Langone’s Center for Midlife Health and Menopause, said in an interview. Dr. Dunham was not involved in the study.

”Earlier versions of medication in this class have caused liver enzyme elevation.” The trial of this medication showed that there were only transient elevations in liver enzymes, which resolved upon cessation of the medication. Dr. Dunham said. ”If the medicine proves to be safe over long periods of time in different populations, this will be a very significant medication for treating menopausal vasomotor symptoms.”

The research was funded by Astellas Pharma. Dr. Dunham had no disclosures. Dr. Neal-Perry is a scientific advisory board member for Astellas and Ferring Pharmaceuticals, and has received research funding from Merck and Overa.

The drug fezolinetant, a selective neurokinin-3 receptor antagonist under investigation for treatment of menopausal vasomotor symptoms, showed acceptable long-term safety and tolerability during a 1-year phase 3 randomized controlled trial, according to data presented at the annual meeting of the North American Menopause Society. The study, called SKYLIGHT 4, examined fezolinetant treatment, especially in terms of endometrial health.

The findings mean that fezolinetant “may help bridge a gap in the management of vasomotor symptoms,” according to lead author Genevieve Neal-Perry, MD, PhD, chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

This study was an important step in fezolinetant’s path toward potential approval by the Food and Drug Administration for vasomotor symptoms.

”Moderate and severe vasomotor symptoms can adversely affect quality of life of those affected and result in sleep disruption as well as increased risk for heart disease and other high-risk medical problems,” Dr. Neal-Perry said. “Although menopausal hormone therapy significantly improves vasomotor symptoms, it may not be desired or it may not be safe for some women,” resulting in gaps in care and a need for targeted, nonhormonal therapies for hot flashes. A planned study will also assess the safety of the drug in patients with a diagnosis of hormone-sensitive cancer and disorders that increase the risk for blood clots.

”Fezolinetant has a low side effect profile, it is a nonhormonal option, and it is selective for the neurons that trigger and mediate hot flashes,” Dr. Neal-Perry said.

Hot flashes are caused by kisspeptin, neurokinin B, and dynorphin neurons located in the hypothalamus. Fezolinetant works by selectively blocking the neurokinin 3 receptor (NK3R), which regulates a person’s sense of temperature, Dr. Neal-Perry explained. Overactivation of NK3R, resulting from low estrogen levels, plays a role in the hot flashes and cold sweats women experience during menopause.

Drug development for hot flashes ”has been hampered by a lack of knowledge regarding the biological cause,” Dr. Neal-Perry said. “Now that we have a robust understanding of the basic biology of hot flashes, we can develop novel, highly effective, and targeted therapy.”

This safety study involved 1,830 women, ages 40-65, who were experiencing menopausal vasomotor symptoms and were randomly assigned to one of three arms for 52 weeks: 45 mg of fezolinetant, 30 mg of fezolinetant, or a placebo once daily.

The primary endpoints included the percentage of women with endometrial hyperplasia, the percentage of women with endometrial cancer, and the frequency and severity of treatment-emergent adverse events (TEAEs). To meet the primary safety endpoint, no more than 1% of participants could have hyperplasia or malignancy, with an upper confidence interval boundary not greater than 4%. Women who met prespecified criteria for their endometrial health to be assessed, underwent endometrial biopsies at baseline and at the end of the study. Three independent pathologists analyzed the tissue without knowledge of which study arm each sample came from. Among the 599 endometrial biopsy samples, 0.5% of the 203 participants taking 45 mg fezolinetant had hyperplasia while none of the women in the other two arms did. Among the 210 women taking 30 mg of fezolinetant, 0.5% had a malignancy; no malignancies occurred in the other two arms.

Overall adverse events were similar across all three arms, including rates of adverse events leading to discontinuation. The most common adverse events were headache and COVID-19. TEAEs related to the drug were 18.1% in the 45-mg arm, 15.4% in the 30-mg arm, and 17.4% in the placebo arm. Serious adverse events were similar across all three arms, and only 0.5% of participants in the 45-mg arm experienced drug-related serious adverse events, compared with none of the women in the 30-mg arm and 0.2% of women in the placebo group.

”The frequency of transaminase elevations was low, and these TEAEs were generally isolated, transient, and resolved on treatment or with discontinuation,” the authors reported.

The next steps for fezolinetant will be to assess its effect on mood and quality of life measures related to vasomotor symptoms, Dr. Neal-Perry said.

Samantha Dunham, MD, a NAMS-certified menopause practitioner and an associate professor of obstetrics and gynecology at New York University, suggested the drug’s safety in the study is encouraging.

”As a medication that treats menopausal symptoms, the study confirmed there are no issues with the endometrium, or lining of the uterus, not that one would expect issues given the mechanism of action,” Dr. Dunham, also codirector of NYU Langone’s Center for Midlife Health and Menopause, said in an interview. Dr. Dunham was not involved in the study.

”Earlier versions of medication in this class have caused liver enzyme elevation.” The trial of this medication showed that there were only transient elevations in liver enzymes, which resolved upon cessation of the medication. Dr. Dunham said. ”If the medicine proves to be safe over long periods of time in different populations, this will be a very significant medication for treating menopausal vasomotor symptoms.”

The research was funded by Astellas Pharma. Dr. Dunham had no disclosures. Dr. Neal-Perry is a scientific advisory board member for Astellas and Ferring Pharmaceuticals, and has received research funding from Merck and Overa.

The drug fezolinetant, a selective neurokinin-3 receptor antagonist under investigation for treatment of menopausal vasomotor symptoms, showed acceptable long-term safety and tolerability during a 1-year phase 3 randomized controlled trial, according to data presented at the annual meeting of the North American Menopause Society. The study, called SKYLIGHT 4, examined fezolinetant treatment, especially in terms of endometrial health.

The findings mean that fezolinetant “may help bridge a gap in the management of vasomotor symptoms,” according to lead author Genevieve Neal-Perry, MD, PhD, chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

This study was an important step in fezolinetant’s path toward potential approval by the Food and Drug Administration for vasomotor symptoms.

”Moderate and severe vasomotor symptoms can adversely affect quality of life of those affected and result in sleep disruption as well as increased risk for heart disease and other high-risk medical problems,” Dr. Neal-Perry said. “Although menopausal hormone therapy significantly improves vasomotor symptoms, it may not be desired or it may not be safe for some women,” resulting in gaps in care and a need for targeted, nonhormonal therapies for hot flashes. A planned study will also assess the safety of the drug in patients with a diagnosis of hormone-sensitive cancer and disorders that increase the risk for blood clots.

”Fezolinetant has a low side effect profile, it is a nonhormonal option, and it is selective for the neurons that trigger and mediate hot flashes,” Dr. Neal-Perry said.

Hot flashes are caused by kisspeptin, neurokinin B, and dynorphin neurons located in the hypothalamus. Fezolinetant works by selectively blocking the neurokinin 3 receptor (NK3R), which regulates a person’s sense of temperature, Dr. Neal-Perry explained. Overactivation of NK3R, resulting from low estrogen levels, plays a role in the hot flashes and cold sweats women experience during menopause.

Drug development for hot flashes ”has been hampered by a lack of knowledge regarding the biological cause,” Dr. Neal-Perry said. “Now that we have a robust understanding of the basic biology of hot flashes, we can develop novel, highly effective, and targeted therapy.”

This safety study involved 1,830 women, ages 40-65, who were experiencing menopausal vasomotor symptoms and were randomly assigned to one of three arms for 52 weeks: 45 mg of fezolinetant, 30 mg of fezolinetant, or a placebo once daily.

The primary endpoints included the percentage of women with endometrial hyperplasia, the percentage of women with endometrial cancer, and the frequency and severity of treatment-emergent adverse events (TEAEs). To meet the primary safety endpoint, no more than 1% of participants could have hyperplasia or malignancy, with an upper confidence interval boundary not greater than 4%. Women who met prespecified criteria for their endometrial health to be assessed, underwent endometrial biopsies at baseline and at the end of the study. Three independent pathologists analyzed the tissue without knowledge of which study arm each sample came from. Among the 599 endometrial biopsy samples, 0.5% of the 203 participants taking 45 mg fezolinetant had hyperplasia while none of the women in the other two arms did. Among the 210 women taking 30 mg of fezolinetant, 0.5% had a malignancy; no malignancies occurred in the other two arms.

Overall adverse events were similar across all three arms, including rates of adverse events leading to discontinuation. The most common adverse events were headache and COVID-19. TEAEs related to the drug were 18.1% in the 45-mg arm, 15.4% in the 30-mg arm, and 17.4% in the placebo arm. Serious adverse events were similar across all three arms, and only 0.5% of participants in the 45-mg arm experienced drug-related serious adverse events, compared with none of the women in the 30-mg arm and 0.2% of women in the placebo group.

”The frequency of transaminase elevations was low, and these TEAEs were generally isolated, transient, and resolved on treatment or with discontinuation,” the authors reported.

The next steps for fezolinetant will be to assess its effect on mood and quality of life measures related to vasomotor symptoms, Dr. Neal-Perry said.

Samantha Dunham, MD, a NAMS-certified menopause practitioner and an associate professor of obstetrics and gynecology at New York University, suggested the drug’s safety in the study is encouraging.

”As a medication that treats menopausal symptoms, the study confirmed there are no issues with the endometrium, or lining of the uterus, not that one would expect issues given the mechanism of action,” Dr. Dunham, also codirector of NYU Langone’s Center for Midlife Health and Menopause, said in an interview. Dr. Dunham was not involved in the study.

”Earlier versions of medication in this class have caused liver enzyme elevation.” The trial of this medication showed that there were only transient elevations in liver enzymes, which resolved upon cessation of the medication. Dr. Dunham said. ”If the medicine proves to be safe over long periods of time in different populations, this will be a very significant medication for treating menopausal vasomotor symptoms.”

The research was funded by Astellas Pharma. Dr. Dunham had no disclosures. Dr. Neal-Perry is a scientific advisory board member for Astellas and Ferring Pharmaceuticals, and has received research funding from Merck and Overa.

Transplantation of cadaveric pancreatic islet cells resulted in graft survival and function with acceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.

The study is a long-term follow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cell product for treating people with type 1 diabetes.

One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawareness, and the other trial included 24 people who also experienced those complications and were already receiving immunosuppression following kidney transplant. The trials, both registered with the U.S. Food and Drug Administration (FDA), met their primary efficacy and safety endpoints at 2- and 3-year timepoints.

The follow-up data have now been published in Diabetes Care by Michael Rickels, MD, and colleagues.

The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized immunosuppression using methods that Dr. Rickels and colleagues have been developing since 2004. The approach involves multiple modalities to protect the islets prior to transplantation.

Among the 34 islet-alone and eight islet-after–kidney transplant recipients who entered the extended follow-up, durable graft survival allowing for achievement of glycemic targets occurred without severe hypoglycemia or adverse effects from immunosuppression.

The primary outcome, actuarial survival of graft islet function, was 56% at the maximum follow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after–kidney transplantation group (P = .004).

The findings suggest that “in the long run, islet transplantation has efficacy, including among those who have had kidney transplants ... Most type 1 diabetes patients are improved tremendously with current insulin delivery systems ... but for those having the most difficulty controlling their blood sugar – and those whose diabetes has already been complicated by needing a kidney transplant – the outcomes we saw in this study are what we’ve been hoping to achieve for more than 20 years,” said Dr. Rickels in a statement from his institution, the University of Pennsylvania, Philadelphia.

In the initial trials at day 75 after the initial transplant, 87.5% of the islet-alone and 71% of the islet-after–kidney transplant group achieved hemoglobin A1c under 7%, and 85% and 54%, respectively, achieved A1c at or under 6.5%. At the end of maximal follow-up, 49% of islet-only transplant recipients maintained A1c under 7%, although none had A1c at or under 6.5%. For the islet-after–kidney transplant group, these proportions were 35% and 17%, respectively (P = .0017 for A1c under 7.0% and P < .0001 for A1c ≤ 6.5%, respectively, between the groups).

There were 12 severe hypoglycemic episodes in five patients (three islet-alone and two islet-after–kidney transplant group) during the initial trials, but no additional episodes occurred in either group during long-term follow-up.  

Overall, 53 individuals – 37 in the islet-alone and 16 in the islet-after–kidney transplant group – or 74% of the total, achieved a period of insulin independence with A1c under 7%, ranging from 36 to 481 days. The range of time to achieving insulin independence reflects individuals who received one, two, or three islet infusions.

The fact that most patients achieved insulin independence following just one (n = 20) or two (n = 30) infusions and only three patients required three infusions was notable, Dr. Rickels said.

“Currently, around the world, there’s an expectation of two to three donor pancreases being needed. Here, it’s one, maybe two. It’s a much more efficient protocol and opens up access for more islet transplantation as a hoped-for alternative to pancreas transplants.”

Of those who achieved insulin independence, 30 (57%) remained insulin-independent throughout follow-up (20 of 37 islet-alone and 10 of 16 islet-after–kidney transplant patients), with no difference in duration of insulin independence between the groups.

There were no deaths during post-transplant follow-up. Rates of serious adverse events were 0.31 and 0.43 per patient-year for the islet-after–kidney and islet-alone transplant groups, respectively. Of a total of 104 serious adverse events, 65 occurred during the initial trials and had been previously reported. Of the additional 39 serious adverse events that occurred during long-term follow-up, 11 were possibly due to immunosuppression and 27 were deemed unrelated to the procedures.

According to Dr. Rickels, “These are the most seriously affected patients, and you’d be expecting to see some hospitalizations in a population managed on immunosuppression therapy ... It’s important to note that none of the adverse events were related to the actual islet product. Also, kidney function remained stable during long-term follow-up in both cohorts, in fact, improving in those who had kidney transplants.”

Overall, he said, “This is a much less invasive procedure that opens itself up to significantly fewer complications than what many of these patients would otherwise require, a pancreas transplant, which involves major abdominal surgery.”

The investigators plan to submit these data as part of a biologic license application (BLA) to the FDA.

The research was supported by grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Allergy and Infectious Diseases. Dr. Rickels has reported receiving consulting fees from Sernova and Vertex Pharmaceuticals.

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

Transplantation of cadaveric pancreatic islet cells resulted in graft survival and function with acceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.

The study is a long-term follow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cell product for treating people with type 1 diabetes.

One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawareness, and the other trial included 24 people who also experienced those complications and were already receiving immunosuppression following kidney transplant. The trials, both registered with the U.S. Food and Drug Administration (FDA), met their primary efficacy and safety endpoints at 2- and 3-year timepoints.

The follow-up data have now been published in Diabetes Care by Michael Rickels, MD, and colleagues.

The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized immunosuppression using methods that Dr. Rickels and colleagues have been developing since 2004. The approach involves multiple modalities to protect the islets prior to transplantation.

Among the 34 islet-alone and eight islet-after–kidney transplant recipients who entered the extended follow-up, durable graft survival allowing for achievement of glycemic targets occurred without severe hypoglycemia or adverse effects from immunosuppression.

The primary outcome, actuarial survival of graft islet function, was 56% at the maximum follow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after–kidney transplantation group (P = .004).

The findings suggest that “in the long run, islet transplantation has efficacy, including among those who have had kidney transplants ... Most type 1 diabetes patients are improved tremendously with current insulin delivery systems ... but for those having the most difficulty controlling their blood sugar – and those whose diabetes has already been complicated by needing a kidney transplant – the outcomes we saw in this study are what we’ve been hoping to achieve for more than 20 years,” said Dr. Rickels in a statement from his institution, the University of Pennsylvania, Philadelphia.

In the initial trials at day 75 after the initial transplant, 87.5% of the islet-alone and 71% of the islet-after–kidney transplant group achieved hemoglobin A1c under 7%, and 85% and 54%, respectively, achieved A1c at or under 6.5%. At the end of maximal follow-up, 49% of islet-only transplant recipients maintained A1c under 7%, although none had A1c at or under 6.5%. For the islet-after–kidney transplant group, these proportions were 35% and 17%, respectively (P = .0017 for A1c under 7.0% and P < .0001 for A1c ≤ 6.5%, respectively, between the groups).

There were 12 severe hypoglycemic episodes in five patients (three islet-alone and two islet-after–kidney transplant group) during the initial trials, but no additional episodes occurred in either group during long-term follow-up.  

Overall, 53 individuals – 37 in the islet-alone and 16 in the islet-after–kidney transplant group – or 74% of the total, achieved a period of insulin independence with A1c under 7%, ranging from 36 to 481 days. The range of time to achieving insulin independence reflects individuals who received one, two, or three islet infusions.

The fact that most patients achieved insulin independence following just one (n = 20) or two (n = 30) infusions and only three patients required three infusions was notable, Dr. Rickels said.

“Currently, around the world, there’s an expectation of two to three donor pancreases being needed. Here, it’s one, maybe two. It’s a much more efficient protocol and opens up access for more islet transplantation as a hoped-for alternative to pancreas transplants.”

Of those who achieved insulin independence, 30 (57%) remained insulin-independent throughout follow-up (20 of 37 islet-alone and 10 of 16 islet-after–kidney transplant patients), with no difference in duration of insulin independence between the groups.

There were no deaths during post-transplant follow-up. Rates of serious adverse events were 0.31 and 0.43 per patient-year for the islet-after–kidney and islet-alone transplant groups, respectively. Of a total of 104 serious adverse events, 65 occurred during the initial trials and had been previously reported. Of the additional 39 serious adverse events that occurred during long-term follow-up, 11 were possibly due to immunosuppression and 27 were deemed unrelated to the procedures.

According to Dr. Rickels, “These are the most seriously affected patients, and you’d be expecting to see some hospitalizations in a population managed on immunosuppression therapy ... It’s important to note that none of the adverse events were related to the actual islet product. Also, kidney function remained stable during long-term follow-up in both cohorts, in fact, improving in those who had kidney transplants.”

Overall, he said, “This is a much less invasive procedure that opens itself up to significantly fewer complications than what many of these patients would otherwise require, a pancreas transplant, which involves major abdominal surgery.”

The investigators plan to submit these data as part of a biologic license application (BLA) to the FDA.

The research was supported by grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Allergy and Infectious Diseases. Dr. Rickels has reported receiving consulting fees from Sernova and Vertex Pharmaceuticals.

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

Transplantation of cadaveric pancreatic islet cells resulted in graft survival and function with acceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.

The study is a long-term follow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cell product for treating people with type 1 diabetes.

One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawareness, and the other trial included 24 people who also experienced those complications and were already receiving immunosuppression following kidney transplant. The trials, both registered with the U.S. Food and Drug Administration (FDA), met their primary efficacy and safety endpoints at 2- and 3-year timepoints.

The follow-up data have now been published in Diabetes Care by Michael Rickels, MD, and colleagues.

The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized immunosuppression using methods that Dr. Rickels and colleagues have been developing since 2004. The approach involves multiple modalities to protect the islets prior to transplantation.

Among the 34 islet-alone and eight islet-after–kidney transplant recipients who entered the extended follow-up, durable graft survival allowing for achievement of glycemic targets occurred without severe hypoglycemia or adverse effects from immunosuppression.

The primary outcome, actuarial survival of graft islet function, was 56% at the maximum follow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after–kidney transplantation group (P = .004).

The findings suggest that “in the long run, islet transplantation has efficacy, including among those who have had kidney transplants ... Most type 1 diabetes patients are improved tremendously with current insulin delivery systems ... but for those having the most difficulty controlling their blood sugar – and those whose diabetes has already been complicated by needing a kidney transplant – the outcomes we saw in this study are what we’ve been hoping to achieve for more than 20 years,” said Dr. Rickels in a statement from his institution, the University of Pennsylvania, Philadelphia.

In the initial trials at day 75 after the initial transplant, 87.5% of the islet-alone and 71% of the islet-after–kidney transplant group achieved hemoglobin A1c under 7%, and 85% and 54%, respectively, achieved A1c at or under 6.5%. At the end of maximal follow-up, 49% of islet-only transplant recipients maintained A1c under 7%, although none had A1c at or under 6.5%. For the islet-after–kidney transplant group, these proportions were 35% and 17%, respectively (P = .0017 for A1c under 7.0% and P < .0001 for A1c ≤ 6.5%, respectively, between the groups).

There were 12 severe hypoglycemic episodes in five patients (three islet-alone and two islet-after–kidney transplant group) during the initial trials, but no additional episodes occurred in either group during long-term follow-up.  

Overall, 53 individuals – 37 in the islet-alone and 16 in the islet-after–kidney transplant group – or 74% of the total, achieved a period of insulin independence with A1c under 7%, ranging from 36 to 481 days. The range of time to achieving insulin independence reflects individuals who received one, two, or three islet infusions.

The fact that most patients achieved insulin independence following just one (n = 20) or two (n = 30) infusions and only three patients required three infusions was notable, Dr. Rickels said.

“Currently, around the world, there’s an expectation of two to three donor pancreases being needed. Here, it’s one, maybe two. It’s a much more efficient protocol and opens up access for more islet transplantation as a hoped-for alternative to pancreas transplants.”

Of those who achieved insulin independence, 30 (57%) remained insulin-independent throughout follow-up (20 of 37 islet-alone and 10 of 16 islet-after–kidney transplant patients), with no difference in duration of insulin independence between the groups.

There were no deaths during post-transplant follow-up. Rates of serious adverse events were 0.31 and 0.43 per patient-year for the islet-after–kidney and islet-alone transplant groups, respectively. Of a total of 104 serious adverse events, 65 occurred during the initial trials and had been previously reported. Of the additional 39 serious adverse events that occurred during long-term follow-up, 11 were possibly due to immunosuppression and 27 were deemed unrelated to the procedures.

According to Dr. Rickels, “These are the most seriously affected patients, and you’d be expecting to see some hospitalizations in a population managed on immunosuppression therapy ... It’s important to note that none of the adverse events were related to the actual islet product. Also, kidney function remained stable during long-term follow-up in both cohorts, in fact, improving in those who had kidney transplants.”

Overall, he said, “This is a much less invasive procedure that opens itself up to significantly fewer complications than what many of these patients would otherwise require, a pancreas transplant, which involves major abdominal surgery.”

The investigators plan to submit these data as part of a biologic license application (BLA) to the FDA.

The research was supported by grants from JDRF, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Allergy and Infectious Diseases. Dr. Rickels has reported receiving consulting fees from Sernova and Vertex Pharmaceuticals.

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

Symptoms of menopause can significantly disrupt a woman’s ability to work, according to a cross-sectional study presented at the annual meeting of the North American Menopause Society.

The study, by researchers at the Mayo Clinic, found that roughly one in eight women said issues stemming from menopause caused them to miss multiple days of work; reduce hours on the job; and even quit, retire, or be laid off.

“We were shocked to see the significant impact of menopause symptoms in the workplace,” Ekta Kapoor, MD, an associate professor of medicine at the Mayo Clinic in Rochester, Minn. said in an interview. “The potential economic impact of untreated menopause symptoms at the workplace is mind-boggling.”

The findings represent an opportunity to improve the treatment of menopause symptoms in working women and “draw attention to the need for creation of workplace policies that include education of employers, managers, and supervisors in order to support midlife women during this universal life stage transition,” Dr. Kapoor added.

Laurie Jeffers, DNP, certified menopause practitioner and codirector of the Center for Midlife Health and Menopause within the department of obstetrics & gynecology at New York University Langone Health, said the findings agree with the results of previous studies from the Netherlands and elsewhere.

“We know that across different studies up to 80% of women during the menopause transition and early post menopause will have high symptom burden, with vasomotor symptoms being the most common,” Dr. Jeffers said. “Psychological symptoms were notably significant in this study, which is also not surprising given that there can be an exacerbation of anxiety or depression during the menopausal transition due to the variability of hormonal activity during this time.”
 

4,400 women surveyed

Dr. Kapoor and colleagues analyzed data from 4,440 currently employed women, ages 45-60, who were enrolled in the Mayo Clinic Registry of Midlife Women and completed an online questionnaire between March and June 2021 about their menopause symptoms and the symptoms’ effects on their work. The participants all receive their primary care at one of four Mayo Clinic sites in Rochester; Scottsdale, Ariz.; Jacksonville, Fla.; and northwest Wisconsin.

The researchers defined an adverse outcome from a menopausal symptom as one that directly caused women to miss a day from work in the past year or, within the past 6 months, to cut back on work hours, to experience a layoff or job termination, or to quit, retire or change jobs.

Most of the respondents were White (95%), married (77%), and had at least a college degree (59%), and their average age was 54. Their overall average Menopause Rating Scale (MRS) score – including somatic, psychological, and urogenital domains – was 23.1, which indicated a severe level of menopause symptoms.

More than one in eight women (13%) reported having at least one adverse outcome because of menopause symptoms, most commonly missing work (11%).

The women reported missing an average 3 days of work because of menopause symptoms. About half as many (6%) reported cutting back on hours at work in the past 6 months. A small percentage reported being laid off in the past 6 months (0.3%), or quitting, retiring, or changing jobs in the past 6 months (1%) because of menopause symptoms.

Menopause symptoms may well be contributing to the gender wage gap, Dr. Kapoor said, in the same way that other factors affect women’s overall earnings, such as taking time off for having or raising a family, being responsible for a large share of housework, and taking on more mentoring or teaching roles that aren’t as highly valued at work.

“Women going through the menopause transition, and those who are postmenopausal, are at important stages of their careers,” Dr. Kapoor said. “They are often seeking, or already in leadership positions. Any impediments at this important stage in their professional lives can prove to be very costly, resulting in missed opportunities for promotion and leadership roles.”

Unsurprisingly, the higher a woman’s MRS score, the more likely she was to report an adverse work outcome, regardless of the symptom. For example, women whose symptom severity ranked in the top 25% overall were 15.6 times more likely to have an adverse work experience than those with the lowest level of symptoms (P < .001). Psychological symptoms had the greatest effect on work. Women whose psychological symptoms ranked in the top 25% in terms of severity were 21 times more likely to have an adverse work effect, compared with those with the lowest level of severity, according to the researchers.

The results echo findings from a recent survey from Carrot Fertility of 1,000 women, ages 40-55, about the effects of menopause on their careers. In that survey, 79% of respondents described working during menopause as more challenging than other common life stages and life experiences, including starting a new job, starting a family or getting a promotion.

Yet 77% of women felt uncomfortable talking with executives about the problem, and 63% didn’t feel comfortable talking to human resources about the issue. More than half (58%) didn’t want to discuss it with their immediate supervisor. Only 8% said their employer has offered significant support for menopause.

“Menopause symptoms continue to be undertreated for a variety of reasons [and] impact multiple aspects of a woman’s life, including her performance in the workplace,” Dr. Kapoor said. “In addition to focusing our attention on adequate treatment of menopause symptoms, we need advocacy for creation of workplace policies that can help women navigate this important and universal stage of their lives.”

Those policies might include education about menopause to increase knowledge and awareness among employers and managers, Dr. Kapoor said. She also noted the need to improve communication with women in discussing appropriate support and work adjustments during menopause.

"There is also evidence that less than 20%-30% of women seek help for their symptoms,” Dr. Jeffers said. “There are a variety of evidence-based hormonal and nonhormonal options available to ease these symptoms, and knowledgeable clinical management of these symptoms can favorably impact this transition. This study is interesting in that the population of women surveyed presumably had access to high-quality health resources and yet still had a high symptom burden.”

Dr. Kapoor cautioned that the data collection occurred in the midst of the COVID-19 pandemic, “which may have heightened the adverse experiences of women at the workplace. On the other hand, many of these women may have been working from home, which may have made their menopause experience more favorable than it would have been had they been working in actual offices,” thereby again underrepresenting the problem.

Dr. Kapoor added that the study population may not be representative since they all received treatment at a tertiary health care center and were almost all White women.

“Perhaps the impact of menopause symptoms in the minority populations and the community is even greater,” Dr. Kapoor said. “Our data might be underrepresenting the extent of the problem.”

The research did not use external funding. Dr. Kapoor has received grant support from Mithra Pharmaceuticals and consulted for Astellas, Mithra Pharmaceuticals, Scynexis, and Womaness. Dr. Jeffers had no disclosures.

*This story was updated on Nov. 28, 2022.

Symptoms of menopause can significantly disrupt a woman’s ability to work, according to a cross-sectional study presented at the annual meeting of the North American Menopause Society.

The study, by researchers at the Mayo Clinic, found that roughly one in eight women said issues stemming from menopause caused them to miss multiple days of work; reduce hours on the job; and even quit, retire, or be laid off.

“We were shocked to see the significant impact of menopause symptoms in the workplace,” Ekta Kapoor, MD, an associate professor of medicine at the Mayo Clinic in Rochester, Minn. said in an interview. “The potential economic impact of untreated menopause symptoms at the workplace is mind-boggling.”

The findings represent an opportunity to improve the treatment of menopause symptoms in working women and “draw attention to the need for creation of workplace policies that include education of employers, managers, and supervisors in order to support midlife women during this universal life stage transition,” Dr. Kapoor added.

Laurie Jeffers, DNP, certified menopause practitioner and codirector of the Center for Midlife Health and Menopause within the department of obstetrics & gynecology at New York University Langone Health, said the findings agree with the results of previous studies from the Netherlands and elsewhere.

“We know that across different studies up to 80% of women during the menopause transition and early post menopause will have high symptom burden, with vasomotor symptoms being the most common,” Dr. Jeffers said. “Psychological symptoms were notably significant in this study, which is also not surprising given that there can be an exacerbation of anxiety or depression during the menopausal transition due to the variability of hormonal activity during this time.”
 

4,400 women surveyed

Dr. Kapoor and colleagues analyzed data from 4,440 currently employed women, ages 45-60, who were enrolled in the Mayo Clinic Registry of Midlife Women and completed an online questionnaire between March and June 2021 about their menopause symptoms and the symptoms’ effects on their work. The participants all receive their primary care at one of four Mayo Clinic sites in Rochester; Scottsdale, Ariz.; Jacksonville, Fla.; and northwest Wisconsin.

The researchers defined an adverse outcome from a menopausal symptom as one that directly caused women to miss a day from work in the past year or, within the past 6 months, to cut back on work hours, to experience a layoff or job termination, or to quit, retire or change jobs.

Most of the respondents were White (95%), married (77%), and had at least a college degree (59%), and their average age was 54. Their overall average Menopause Rating Scale (MRS) score – including somatic, psychological, and urogenital domains – was 23.1, which indicated a severe level of menopause symptoms.

More than one in eight women (13%) reported having at least one adverse outcome because of menopause symptoms, most commonly missing work (11%).

The women reported missing an average 3 days of work because of menopause symptoms. About half as many (6%) reported cutting back on hours at work in the past 6 months. A small percentage reported being laid off in the past 6 months (0.3%), or quitting, retiring, or changing jobs in the past 6 months (1%) because of menopause symptoms.

Menopause symptoms may well be contributing to the gender wage gap, Dr. Kapoor said, in the same way that other factors affect women’s overall earnings, such as taking time off for having or raising a family, being responsible for a large share of housework, and taking on more mentoring or teaching roles that aren’t as highly valued at work.

“Women going through the menopause transition, and those who are postmenopausal, are at important stages of their careers,” Dr. Kapoor said. “They are often seeking, or already in leadership positions. Any impediments at this important stage in their professional lives can prove to be very costly, resulting in missed opportunities for promotion and leadership roles.”

Unsurprisingly, the higher a woman’s MRS score, the more likely she was to report an adverse work outcome, regardless of the symptom. For example, women whose symptom severity ranked in the top 25% overall were 15.6 times more likely to have an adverse work experience than those with the lowest level of symptoms (P < .001). Psychological symptoms had the greatest effect on work. Women whose psychological symptoms ranked in the top 25% in terms of severity were 21 times more likely to have an adverse work effect, compared with those with the lowest level of severity, according to the researchers.

The results echo findings from a recent survey from Carrot Fertility of 1,000 women, ages 40-55, about the effects of menopause on their careers. In that survey, 79% of respondents described working during menopause as more challenging than other common life stages and life experiences, including starting a new job, starting a family or getting a promotion.

Yet 77% of women felt uncomfortable talking with executives about the problem, and 63% didn’t feel comfortable talking to human resources about the issue. More than half (58%) didn’t want to discuss it with their immediate supervisor. Only 8% said their employer has offered significant support for menopause.

“Menopause symptoms continue to be undertreated for a variety of reasons [and] impact multiple aspects of a woman’s life, including her performance in the workplace,” Dr. Kapoor said. “In addition to focusing our attention on adequate treatment of menopause symptoms, we need advocacy for creation of workplace policies that can help women navigate this important and universal stage of their lives.”

Those policies might include education about menopause to increase knowledge and awareness among employers and managers, Dr. Kapoor said. She also noted the need to improve communication with women in discussing appropriate support and work adjustments during menopause.

"There is also evidence that less than 20%-30% of women seek help for their symptoms,” Dr. Jeffers said. “There are a variety of evidence-based hormonal and nonhormonal options available to ease these symptoms, and knowledgeable clinical management of these symptoms can favorably impact this transition. This study is interesting in that the population of women surveyed presumably had access to high-quality health resources and yet still had a high symptom burden.”

Dr. Kapoor cautioned that the data collection occurred in the midst of the COVID-19 pandemic, “which may have heightened the adverse experiences of women at the workplace. On the other hand, many of these women may have been working from home, which may have made their menopause experience more favorable than it would have been had they been working in actual offices,” thereby again underrepresenting the problem.

Dr. Kapoor added that the study population may not be representative since they all received treatment at a tertiary health care center and were almost all White women.

“Perhaps the impact of menopause symptoms in the minority populations and the community is even greater,” Dr. Kapoor said. “Our data might be underrepresenting the extent of the problem.”

The research did not use external funding. Dr. Kapoor has received grant support from Mithra Pharmaceuticals and consulted for Astellas, Mithra Pharmaceuticals, Scynexis, and Womaness. Dr. Jeffers had no disclosures.

*This story was updated on Nov. 28, 2022.

Symptoms of menopause can significantly disrupt a woman’s ability to work, according to a cross-sectional study presented at the annual meeting of the North American Menopause Society.

The study, by researchers at the Mayo Clinic, found that roughly one in eight women said issues stemming from menopause caused them to miss multiple days of work; reduce hours on the job; and even quit, retire, or be laid off.

“We were shocked to see the significant impact of menopause symptoms in the workplace,” Ekta Kapoor, MD, an associate professor of medicine at the Mayo Clinic in Rochester, Minn. said in an interview. “The potential economic impact of untreated menopause symptoms at the workplace is mind-boggling.”

The findings represent an opportunity to improve the treatment of menopause symptoms in working women and “draw attention to the need for creation of workplace policies that include education of employers, managers, and supervisors in order to support midlife women during this universal life stage transition,” Dr. Kapoor added.

Laurie Jeffers, DNP, certified menopause practitioner and codirector of the Center for Midlife Health and Menopause within the department of obstetrics & gynecology at New York University Langone Health, said the findings agree with the results of previous studies from the Netherlands and elsewhere.

“We know that across different studies up to 80% of women during the menopause transition and early post menopause will have high symptom burden, with vasomotor symptoms being the most common,” Dr. Jeffers said. “Psychological symptoms were notably significant in this study, which is also not surprising given that there can be an exacerbation of anxiety or depression during the menopausal transition due to the variability of hormonal activity during this time.”
 

4,400 women surveyed

Dr. Kapoor and colleagues analyzed data from 4,440 currently employed women, ages 45-60, who were enrolled in the Mayo Clinic Registry of Midlife Women and completed an online questionnaire between March and June 2021 about their menopause symptoms and the symptoms’ effects on their work. The participants all receive their primary care at one of four Mayo Clinic sites in Rochester; Scottsdale, Ariz.; Jacksonville, Fla.; and northwest Wisconsin.

The researchers defined an adverse outcome from a menopausal symptom as one that directly caused women to miss a day from work in the past year or, within the past 6 months, to cut back on work hours, to experience a layoff or job termination, or to quit, retire or change jobs.

Most of the respondents were White (95%), married (77%), and had at least a college degree (59%), and their average age was 54. Their overall average Menopause Rating Scale (MRS) score – including somatic, psychological, and urogenital domains – was 23.1, which indicated a severe level of menopause symptoms.

More than one in eight women (13%) reported having at least one adverse outcome because of menopause symptoms, most commonly missing work (11%).

The women reported missing an average 3 days of work because of menopause symptoms. About half as many (6%) reported cutting back on hours at work in the past 6 months. A small percentage reported being laid off in the past 6 months (0.3%), or quitting, retiring, or changing jobs in the past 6 months (1%) because of menopause symptoms.

Menopause symptoms may well be contributing to the gender wage gap, Dr. Kapoor said, in the same way that other factors affect women’s overall earnings, such as taking time off for having or raising a family, being responsible for a large share of housework, and taking on more mentoring or teaching roles that aren’t as highly valued at work.

“Women going through the menopause transition, and those who are postmenopausal, are at important stages of their careers,” Dr. Kapoor said. “They are often seeking, or already in leadership positions. Any impediments at this important stage in their professional lives can prove to be very costly, resulting in missed opportunities for promotion and leadership roles.”

Unsurprisingly, the higher a woman’s MRS score, the more likely she was to report an adverse work outcome, regardless of the symptom. For example, women whose symptom severity ranked in the top 25% overall were 15.6 times more likely to have an adverse work experience than those with the lowest level of symptoms (P < .001). Psychological symptoms had the greatest effect on work. Women whose psychological symptoms ranked in the top 25% in terms of severity were 21 times more likely to have an adverse work effect, compared with those with the lowest level of severity, according to the researchers.

The results echo findings from a recent survey from Carrot Fertility of 1,000 women, ages 40-55, about the effects of menopause on their careers. In that survey, 79% of respondents described working during menopause as more challenging than other common life stages and life experiences, including starting a new job, starting a family or getting a promotion.

Yet 77% of women felt uncomfortable talking with executives about the problem, and 63% didn’t feel comfortable talking to human resources about the issue. More than half (58%) didn’t want to discuss it with their immediate supervisor. Only 8% said their employer has offered significant support for menopause.

“Menopause symptoms continue to be undertreated for a variety of reasons [and] impact multiple aspects of a woman’s life, including her performance in the workplace,” Dr. Kapoor said. “In addition to focusing our attention on adequate treatment of menopause symptoms, we need advocacy for creation of workplace policies that can help women navigate this important and universal stage of their lives.”

Those policies might include education about menopause to increase knowledge and awareness among employers and managers, Dr. Kapoor said. She also noted the need to improve communication with women in discussing appropriate support and work adjustments during menopause.

"There is also evidence that less than 20%-30% of women seek help for their symptoms,” Dr. Jeffers said. “There are a variety of evidence-based hormonal and nonhormonal options available to ease these symptoms, and knowledgeable clinical management of these symptoms can favorably impact this transition. This study is interesting in that the population of women surveyed presumably had access to high-quality health resources and yet still had a high symptom burden.”

Dr. Kapoor cautioned that the data collection occurred in the midst of the COVID-19 pandemic, “which may have heightened the adverse experiences of women at the workplace. On the other hand, many of these women may have been working from home, which may have made their menopause experience more favorable than it would have been had they been working in actual offices,” thereby again underrepresenting the problem.

Dr. Kapoor added that the study population may not be representative since they all received treatment at a tertiary health care center and were almost all White women.

“Perhaps the impact of menopause symptoms in the minority populations and the community is even greater,” Dr. Kapoor said. “Our data might be underrepresenting the extent of the problem.”

The research did not use external funding. Dr. Kapoor has received grant support from Mithra Pharmaceuticals and consulted for Astellas, Mithra Pharmaceuticals, Scynexis, and Womaness. Dr. Jeffers had no disclosures.

*This story was updated on Nov. 28, 2022.

A majority of hospitalized patients at low risk for venous thromboembolism were unnecessarily treated with medication, based on data from more than 400 individuals.

Prevention of venous thromboembolism (VTE) is important, and current guidelines from the American College of Chest Physicians suggest that patients with high or moderate risk for VTE be treated with mechanical prophylaxis, and that pharmacological prophylaxis is not recommended for patients at high risk for bleeding, said Hui Chong Lau, MD, in a presentation at the annual meeting of the American College of Chest Physicians (CHEST).

However, the nature of VTE prophylaxis using a risk assessment score has not been explored, said Dr. Lau, a third-year resident in internal medicine at Crozer-Chester Medical Center, Upland, Penn.

Low-molecular-weight heparin (LWMH) and intermittent pneumatic compression are often used to reduce VTE risk during hospitalization, but for patients with low VTE risk, prophylaxis is not necessarily recommended, he said. In fact, overuse of chemical prophylaxis in low-risk patients can increase bleeding risk and contribute to patient discomfort in the form of additional needle sticks while hospitalized, Dr. Lau said in the presentation.

“We wanted to see how well physicians in the hospital used a risk assessment model to stratify patients,” and how well the patients were assigned to the correct prophylaxis, he explained.

Dr. Lau and colleagues reviewed data from 469 adult patients hospitalized at a single medical center who were hospitalized between January 2021 and June 2021. The researchers retrospectively performed risk assessment using the Padua prediction score. A score of less than 4 was considered low risk for VTE, and a score of 4 or higher was considered high risk.

In the study population, 180 patients were identified as low risk and 289 were considered high risk.

Based on the Padua score, 95% of the patients at high risk were on the correct prophylaxis, Dr. Lau said.

A total of 193 high-risk patients were on heparin. However, many of these patients had good kidney function, and could have been treated with enoxaparin instead; “this would have spared them two needle sticks per day,” Dr. Lau noted.

Of the 180 low-risk patients, 168 (93.3%) were on chemical prophylaxis, and should have been on mechanical prophylaxis, he said. Only 10 patients (5%) who were considered low risk were placed on mechanical prophylaxis.

Overall, 3.6% of all patients who received chemical VTE prophylaxis developed bleeding.

The results were limited by the retrospective design and use of data from a single center. However, the findings emphasize the need for better attention to VTE risk when considering prophylaxis, said Dr. Lau. “We have to have risk assessment every day,” during a hospital stay, and adjust treatment accordingly, he said.

“We are likely overusing chemical VTE prophylaxis in low-risk patients,” he concluded.

Additional research is needed to better understand the potential consequences of overusing chemical VTE, including not only bleeding risk, but also financial costs and patient discomfort, he said.

The study received no outside funding. The researchers had no financial conflicts to disclose.

A majority of hospitalized patients at low risk for venous thromboembolism were unnecessarily treated with medication, based on data from more than 400 individuals.

Prevention of venous thromboembolism (VTE) is important, and current guidelines from the American College of Chest Physicians suggest that patients with high or moderate risk for VTE be treated with mechanical prophylaxis, and that pharmacological prophylaxis is not recommended for patients at high risk for bleeding, said Hui Chong Lau, MD, in a presentation at the annual meeting of the American College of Chest Physicians (CHEST).

However, the nature of VTE prophylaxis using a risk assessment score has not been explored, said Dr. Lau, a third-year resident in internal medicine at Crozer-Chester Medical Center, Upland, Penn.

Low-molecular-weight heparin (LWMH) and intermittent pneumatic compression are often used to reduce VTE risk during hospitalization, but for patients with low VTE risk, prophylaxis is not necessarily recommended, he said. In fact, overuse of chemical prophylaxis in low-risk patients can increase bleeding risk and contribute to patient discomfort in the form of additional needle sticks while hospitalized, Dr. Lau said in the presentation.

“We wanted to see how well physicians in the hospital used a risk assessment model to stratify patients,” and how well the patients were assigned to the correct prophylaxis, he explained.

Dr. Lau and colleagues reviewed data from 469 adult patients hospitalized at a single medical center who were hospitalized between January 2021 and June 2021. The researchers retrospectively performed risk assessment using the Padua prediction score. A score of less than 4 was considered low risk for VTE, and a score of 4 or higher was considered high risk.

In the study population, 180 patients were identified as low risk and 289 were considered high risk.

Based on the Padua score, 95% of the patients at high risk were on the correct prophylaxis, Dr. Lau said.

A total of 193 high-risk patients were on heparin. However, many of these patients had good kidney function, and could have been treated with enoxaparin instead; “this would have spared them two needle sticks per day,” Dr. Lau noted.

Of the 180 low-risk patients, 168 (93.3%) were on chemical prophylaxis, and should have been on mechanical prophylaxis, he said. Only 10 patients (5%) who were considered low risk were placed on mechanical prophylaxis.

Overall, 3.6% of all patients who received chemical VTE prophylaxis developed bleeding.

The results were limited by the retrospective design and use of data from a single center. However, the findings emphasize the need for better attention to VTE risk when considering prophylaxis, said Dr. Lau. “We have to have risk assessment every day,” during a hospital stay, and adjust treatment accordingly, he said.

“We are likely overusing chemical VTE prophylaxis in low-risk patients,” he concluded.

Additional research is needed to better understand the potential consequences of overusing chemical VTE, including not only bleeding risk, but also financial costs and patient discomfort, he said.

The study received no outside funding. The researchers had no financial conflicts to disclose.

A majority of hospitalized patients at low risk for venous thromboembolism were unnecessarily treated with medication, based on data from more than 400 individuals.

Prevention of venous thromboembolism (VTE) is important, and current guidelines from the American College of Chest Physicians suggest that patients with high or moderate risk for VTE be treated with mechanical prophylaxis, and that pharmacological prophylaxis is not recommended for patients at high risk for bleeding, said Hui Chong Lau, MD, in a presentation at the annual meeting of the American College of Chest Physicians (CHEST).

However, the nature of VTE prophylaxis using a risk assessment score has not been explored, said Dr. Lau, a third-year resident in internal medicine at Crozer-Chester Medical Center, Upland, Penn.

Low-molecular-weight heparin (LWMH) and intermittent pneumatic compression are often used to reduce VTE risk during hospitalization, but for patients with low VTE risk, prophylaxis is not necessarily recommended, he said. In fact, overuse of chemical prophylaxis in low-risk patients can increase bleeding risk and contribute to patient discomfort in the form of additional needle sticks while hospitalized, Dr. Lau said in the presentation.

“We wanted to see how well physicians in the hospital used a risk assessment model to stratify patients,” and how well the patients were assigned to the correct prophylaxis, he explained.

Dr. Lau and colleagues reviewed data from 469 adult patients hospitalized at a single medical center who were hospitalized between January 2021 and June 2021. The researchers retrospectively performed risk assessment using the Padua prediction score. A score of less than 4 was considered low risk for VTE, and a score of 4 or higher was considered high risk.

In the study population, 180 patients were identified as low risk and 289 were considered high risk.

Based on the Padua score, 95% of the patients at high risk were on the correct prophylaxis, Dr. Lau said.

A total of 193 high-risk patients were on heparin. However, many of these patients had good kidney function, and could have been treated with enoxaparin instead; “this would have spared them two needle sticks per day,” Dr. Lau noted.

Of the 180 low-risk patients, 168 (93.3%) were on chemical prophylaxis, and should have been on mechanical prophylaxis, he said. Only 10 patients (5%) who were considered low risk were placed on mechanical prophylaxis.

Overall, 3.6% of all patients who received chemical VTE prophylaxis developed bleeding.

The results were limited by the retrospective design and use of data from a single center. However, the findings emphasize the need for better attention to VTE risk when considering prophylaxis, said Dr. Lau. “We have to have risk assessment every day,” during a hospital stay, and adjust treatment accordingly, he said.

“We are likely overusing chemical VTE prophylaxis in low-risk patients,” he concluded.

Additional research is needed to better understand the potential consequences of overusing chemical VTE, including not only bleeding risk, but also financial costs and patient discomfort, he said.

The study received no outside funding. The researchers had no financial conflicts to disclose.