Megan Brooks

Results from a large study make a strong case for offering long-acting injectable antipsychotics (LAIs) to patients newly diagnosed with schizophrenia.

Investigators found that among patients who switched to LAIs, mortality was lower and there were fewer suicide attempts in comparison with patients who continued taking the corresponding oral antipsychotic (OAP).

In addition, switching to an LAI antipsychotic within the first 2 years of OAP cut the risk for suicide death by 47%.

“With newly diagnosed schizophrenia, more active consideration of LAIs in this stage for better long-term outcomes (i.e., mortality and suicide risk) should be encouraged, particularly for those who have already exhibited poor adherence attitudes,” Cheng-yi Huang, MD, Bali Psychiatric Center, Ministry of Health and Welfare, New Taipei City, Taiwan, said in an interview.

The study was published online May 11 in JAMA Network Open.
 

Powerful incentive to switch

Using data from the Taiwan National Health Insurance Research Database, the investigators identified patients newly diagnosed with schizophrenia who received OAPs from 2002 to 2017.

Within this cohort, they defined the LAI group as patients who switched to LAIs and were prescribed LAIs at least four times within 1 year. The LAI group was propensity matched to patients who continued receiving OAPs of the same compounds. There were 2,614 patients in each group (median age, 30 years).

During the 16-year follow-up period, compared with patients who continued taking the OAP, those who switched to the LAI had a 34% lower risk for all-cause mortality (adjusted hazard ratio [aHR], 0.66; 95% confidence interval, 0.54-0.81), a 37% lower risk for natural-cause mortality (aHR, 0.63; 95% CI, 0.52-0.76), and a 28% lower risk for suicide attempts (incidence rate ratio, 0.72; 95% CI, 0.55-0.93).

The risk for suicide mortality was 47% lower for patients who switched to LAIs within the first 2 years of having begun taking the OAP (aHR, 0.53; 95% CI, 0.30-0.92).

A recent study from Canada found that the suicide rate among patients with schizophrenia spectrum disorders was more than 20 times higher than that of the general population.

“Clinically, most psychiatrists use LAIs with a conservative attitude, and the reasons for this attitude are generally not well supported by current scientific evidence,” Dr. Huang and colleagues note in their article.

Dr. Huang said the study provides a powerful incentive to begin treatment with LAIs for patients newly diagnosed with schizophrenia.

“Because this study compared depot versus the same oral compound, as soon as patients show response and tolerability to the OAP, they will benefit much more when switching to LAI of the same compound,” Dr. Huang told this news organization.
 

‘Remarkably underutilized’

Commenting on the study for an interview, William Carpenter Jr., MD, Maryland Psychiatric Research Center, University of Maryland, Baltimore, said this report is “very important and in a high-quality journal.”

“LAIs have been remarkably underutilized in the U.S. and not considered as main line and initial treatment. All of this is unfortunate attitude, not science,” Dr. Carpenter said.

There is now evidence that the field is shifting toward LAIs as frontline treatment, “at least conceptually and by research leaders,” he noted.

“In this report, the health and suicide information is new, extremely important, and robust. This report should alert clinicians to possible advantage of LAI in suicide prevention,” Dr. Carpenter added.

Also commenting for this news organization, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences, Staten Island University Hospital, New York, said the findings provide “another very robust argument for LAIs.”

“The decrease in all-cause mortality is really interesting,” said Dr. Sullivan, “and it would be interesting to find out whether some of this reflects improved metabolic states” with LAIs versus OAPs.

The finding that people who switched to LAIs within 2 years were at much lower risk for suicide and other mortality represents a “powerful argument for switching within 2 years,” Dr. Sullivan said.

However, in current clinical practice, clinicians often don’t suggest LAIs until patients have suffered repeated acute episodes of illness after not taking their oral antipsychotics. Such episodes have an impact on the individual and on their nervous system, Dr. Sullivan explained.

“That’s really undesirable. We know from other data that the more episodes someone has, the harder it is to get the illness symptoms under control,” he noted.

“We really ought to be thinking preventively about approaches that will decrease the risk of recurrence, and the evidence in this study is pretty compelling that the LAI was a significant intervention that decreased the risks. Thinking about LAIs as a preventive measure is a message that hasn’t gotten out to the practice community yet,” Dr. Sullivan added.

The study was supported by the Bali Psychiatric Center, Taiwan, through a grant from the Ministry of Health and Welfare. Dr. Huang, Dr. Carpenter, and Dr. Sullivan have disclosed no relevant financial relationships.

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

Results from a large study make a strong case for offering long-acting injectable antipsychotics (LAIs) to patients newly diagnosed with schizophrenia.

Investigators found that among patients who switched to LAIs, mortality was lower and there were fewer suicide attempts in comparison with patients who continued taking the corresponding oral antipsychotic (OAP).

In addition, switching to an LAI antipsychotic within the first 2 years of OAP cut the risk for suicide death by 47%.

“With newly diagnosed schizophrenia, more active consideration of LAIs in this stage for better long-term outcomes (i.e., mortality and suicide risk) should be encouraged, particularly for those who have already exhibited poor adherence attitudes,” Cheng-yi Huang, MD, Bali Psychiatric Center, Ministry of Health and Welfare, New Taipei City, Taiwan, said in an interview.

The study was published online May 11 in JAMA Network Open.
 

Powerful incentive to switch

Using data from the Taiwan National Health Insurance Research Database, the investigators identified patients newly diagnosed with schizophrenia who received OAPs from 2002 to 2017.

Within this cohort, they defined the LAI group as patients who switched to LAIs and were prescribed LAIs at least four times within 1 year. The LAI group was propensity matched to patients who continued receiving OAPs of the same compounds. There were 2,614 patients in each group (median age, 30 years).

During the 16-year follow-up period, compared with patients who continued taking the OAP, those who switched to the LAI had a 34% lower risk for all-cause mortality (adjusted hazard ratio [aHR], 0.66; 95% confidence interval, 0.54-0.81), a 37% lower risk for natural-cause mortality (aHR, 0.63; 95% CI, 0.52-0.76), and a 28% lower risk for suicide attempts (incidence rate ratio, 0.72; 95% CI, 0.55-0.93).

The risk for suicide mortality was 47% lower for patients who switched to LAIs within the first 2 years of having begun taking the OAP (aHR, 0.53; 95% CI, 0.30-0.92).

A recent study from Canada found that the suicide rate among patients with schizophrenia spectrum disorders was more than 20 times higher than that of the general population.

“Clinically, most psychiatrists use LAIs with a conservative attitude, and the reasons for this attitude are generally not well supported by current scientific evidence,” Dr. Huang and colleagues note in their article.

Dr. Huang said the study provides a powerful incentive to begin treatment with LAIs for patients newly diagnosed with schizophrenia.

“Because this study compared depot versus the same oral compound, as soon as patients show response and tolerability to the OAP, they will benefit much more when switching to LAI of the same compound,” Dr. Huang told this news organization.
 

‘Remarkably underutilized’

Commenting on the study for an interview, William Carpenter Jr., MD, Maryland Psychiatric Research Center, University of Maryland, Baltimore, said this report is “very important and in a high-quality journal.”

“LAIs have been remarkably underutilized in the U.S. and not considered as main line and initial treatment. All of this is unfortunate attitude, not science,” Dr. Carpenter said.

There is now evidence that the field is shifting toward LAIs as frontline treatment, “at least conceptually and by research leaders,” he noted.

“In this report, the health and suicide information is new, extremely important, and robust. This report should alert clinicians to possible advantage of LAI in suicide prevention,” Dr. Carpenter added.

Also commenting for this news organization, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences, Staten Island University Hospital, New York, said the findings provide “another very robust argument for LAIs.”

“The decrease in all-cause mortality is really interesting,” said Dr. Sullivan, “and it would be interesting to find out whether some of this reflects improved metabolic states” with LAIs versus OAPs.

The finding that people who switched to LAIs within 2 years were at much lower risk for suicide and other mortality represents a “powerful argument for switching within 2 years,” Dr. Sullivan said.

However, in current clinical practice, clinicians often don’t suggest LAIs until patients have suffered repeated acute episodes of illness after not taking their oral antipsychotics. Such episodes have an impact on the individual and on their nervous system, Dr. Sullivan explained.

“That’s really undesirable. We know from other data that the more episodes someone has, the harder it is to get the illness symptoms under control,” he noted.

“We really ought to be thinking preventively about approaches that will decrease the risk of recurrence, and the evidence in this study is pretty compelling that the LAI was a significant intervention that decreased the risks. Thinking about LAIs as a preventive measure is a message that hasn’t gotten out to the practice community yet,” Dr. Sullivan added.

The study was supported by the Bali Psychiatric Center, Taiwan, through a grant from the Ministry of Health and Welfare. Dr. Huang, Dr. Carpenter, and Dr. Sullivan have disclosed no relevant financial relationships.

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

Results from a large study make a strong case for offering long-acting injectable antipsychotics (LAIs) to patients newly diagnosed with schizophrenia.

Investigators found that among patients who switched to LAIs, mortality was lower and there were fewer suicide attempts in comparison with patients who continued taking the corresponding oral antipsychotic (OAP).

In addition, switching to an LAI antipsychotic within the first 2 years of OAP cut the risk for suicide death by 47%.

“With newly diagnosed schizophrenia, more active consideration of LAIs in this stage for better long-term outcomes (i.e., mortality and suicide risk) should be encouraged, particularly for those who have already exhibited poor adherence attitudes,” Cheng-yi Huang, MD, Bali Psychiatric Center, Ministry of Health and Welfare, New Taipei City, Taiwan, said in an interview.

The study was published online May 11 in JAMA Network Open.
 

Powerful incentive to switch

Using data from the Taiwan National Health Insurance Research Database, the investigators identified patients newly diagnosed with schizophrenia who received OAPs from 2002 to 2017.

Within this cohort, they defined the LAI group as patients who switched to LAIs and were prescribed LAIs at least four times within 1 year. The LAI group was propensity matched to patients who continued receiving OAPs of the same compounds. There were 2,614 patients in each group (median age, 30 years).

During the 16-year follow-up period, compared with patients who continued taking the OAP, those who switched to the LAI had a 34% lower risk for all-cause mortality (adjusted hazard ratio [aHR], 0.66; 95% confidence interval, 0.54-0.81), a 37% lower risk for natural-cause mortality (aHR, 0.63; 95% CI, 0.52-0.76), and a 28% lower risk for suicide attempts (incidence rate ratio, 0.72; 95% CI, 0.55-0.93).

The risk for suicide mortality was 47% lower for patients who switched to LAIs within the first 2 years of having begun taking the OAP (aHR, 0.53; 95% CI, 0.30-0.92).

A recent study from Canada found that the suicide rate among patients with schizophrenia spectrum disorders was more than 20 times higher than that of the general population.

“Clinically, most psychiatrists use LAIs with a conservative attitude, and the reasons for this attitude are generally not well supported by current scientific evidence,” Dr. Huang and colleagues note in their article.

Dr. Huang said the study provides a powerful incentive to begin treatment with LAIs for patients newly diagnosed with schizophrenia.

“Because this study compared depot versus the same oral compound, as soon as patients show response and tolerability to the OAP, they will benefit much more when switching to LAI of the same compound,” Dr. Huang told this news organization.
 

‘Remarkably underutilized’

Commenting on the study for an interview, William Carpenter Jr., MD, Maryland Psychiatric Research Center, University of Maryland, Baltimore, said this report is “very important and in a high-quality journal.”

“LAIs have been remarkably underutilized in the U.S. and not considered as main line and initial treatment. All of this is unfortunate attitude, not science,” Dr. Carpenter said.

There is now evidence that the field is shifting toward LAIs as frontline treatment, “at least conceptually and by research leaders,” he noted.

“In this report, the health and suicide information is new, extremely important, and robust. This report should alert clinicians to possible advantage of LAI in suicide prevention,” Dr. Carpenter added.

Also commenting for this news organization, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences, Staten Island University Hospital, New York, said the findings provide “another very robust argument for LAIs.”

“The decrease in all-cause mortality is really interesting,” said Dr. Sullivan, “and it would be interesting to find out whether some of this reflects improved metabolic states” with LAIs versus OAPs.

The finding that people who switched to LAIs within 2 years were at much lower risk for suicide and other mortality represents a “powerful argument for switching within 2 years,” Dr. Sullivan said.

However, in current clinical practice, clinicians often don’t suggest LAIs until patients have suffered repeated acute episodes of illness after not taking their oral antipsychotics. Such episodes have an impact on the individual and on their nervous system, Dr. Sullivan explained.

“That’s really undesirable. We know from other data that the more episodes someone has, the harder it is to get the illness symptoms under control,” he noted.

“We really ought to be thinking preventively about approaches that will decrease the risk of recurrence, and the evidence in this study is pretty compelling that the LAI was a significant intervention that decreased the risks. Thinking about LAIs as a preventive measure is a message that hasn’t gotten out to the practice community yet,” Dr. Sullivan added.

The study was supported by the Bali Psychiatric Center, Taiwan, through a grant from the Ministry of Health and Welfare. Dr. Huang, Dr. Carpenter, and Dr. Sullivan have disclosed no relevant financial relationships.

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

The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.

The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.

The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .

The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.

“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.

“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.

“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
 

Road map to improve diversity, achieve allyship

The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.

The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.

The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.

It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.

The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.

“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.

“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.

The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.

It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.

The report also highlights additional opportunities to:

• improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
• identify and assist clinicians who experience mental health conditions, , or 
• emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
• increase privacy protections for patient data used in research
• maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
• perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
• expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry

The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.

The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.

This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.

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

The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.

The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.

The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .

The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.

“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.

“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.

“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
 

Road map to improve diversity, achieve allyship

The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.

The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.

The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.

It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.

The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.

“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.

“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.

The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.

It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.

The report also highlights additional opportunities to:

• improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
• identify and assist clinicians who experience mental health conditions, , or 
• emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
• increase privacy protections for patient data used in research
• maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
• perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
• expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry

The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.

The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.

This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.

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

The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.

The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.

The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .

The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.

“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.

“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.

“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
 

Road map to improve diversity, achieve allyship

The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.

The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.

The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.

It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.

The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.

“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.

“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.

The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.

It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.

The report also highlights additional opportunities to:

• improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
• identify and assist clinicians who experience mental health conditions, , or 
• emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
• increase privacy protections for patient data used in research
• maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
• perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
• expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry

The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.

The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.

This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.

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

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

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

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

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

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

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

Psychiatrists often develop long-term relationships with their patients, but what happens when a patient dies? Should the psychiatrist attend the patient’s funeral?

It’s a question Ashley Pettaway, MD, faced as a medical resident at the University of Alabama School of Medicine.

For 2 months, Dr. Pettaway was involved in the day-to-day care of a woman in her 40s who ultimately died. As part of that care, Dr. Pettaway had regular meetings with the patient’s husband and family members.

“The patient was about my mother’s age, so I naturally was kind of attached to her,” Dr. Pettaway told this news organization. After she died, her family invited Dr. Pettaway to the funeral.

“While I couldn’t make it to the funeral, it got me thinking. Should I go? If I go, what do I say? Who do I sit with? How do I introduce myself?” wondered Dr. Pettaway, now a resident in the department of psychiatry and neurobehavioral sciences, University of Virginia, Charlottesville.

She turned to the literature but found very little regarding psychiatrists attending their patients’ funerals. “This was surprising to me because in psychiatry, you can get so engrossed in patients’ lives,” Dr. Pettaway said.

Given the lack of rules or formal guidance on psychiatrists attending patients’ funerals, Dr. Pettaway and her mentor, Gabrielle Marzani, MD, conducted an informal survey of 12 supervising psychiatrists at the University of Virginia.

The survey results were presented at the virtual American Psychiatric Association 2021 Annual Meeting.

Ten of the 12 psychiatrists who were surveyed were caring for a patient who died while under their care. Five of those psychiatrists reported going to at least one patient’s funeral over the course of their career.

Among the psychiatrists who attended a patient’s funeral, their attendance was often based on their clinical intuition, their relationship with the family, or whether the patient was an established presence in the community. In the latter case, the psychiatrist attended as a community member.

The number of years in practice also mattered. Fewer senior faculty reported that they would be hesitant to attend and that they would not attend without a formal invitation from the family. Senior career psychiatrists were more likely to attend and felt that an invitation was not required.

None of the psychiatrists surveyed had received training or guidance on attending patients’ funerals at any point in their career.

Given the absence of formal recommendations, Dr. Pettaway believes increased conversation on this topic as part of residency training programs would help psychiatrists navigate these complex situations.
 

A complex issue

Commenting on the topic for an interview, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, said this is an “interesting and important topic that is underdiscussed.”

“I don’t think there’s a right answer that applies to every situation,” said Dr. Appelbaum, a past president of the APA.

There will be times, he said, when psychiatrists or other mental health professionals have worked closely with a patient for many years and may have interacted with the family over that period.

“When that patient passes away, they may feel, and the family may feel, that it would be comforting and appropriate for them to be at the funeral,” said Dr. Appelbaum.

However, he added, it’s important that psychiatrists “take the lead from the family.”

“There are obviously a number of complexities involved. One is how the family feels about the relationship with the psychiatrist – whether they were accepting of the reality that the patient had a mental disorder and was in treatment,” he said.

There is also the question of confidentiality, said Dr. Appelbaum.

“If it’s a large funeral and the psychiatrist is just one face in the crowd, that’s not likely to be an issue. But if it’s a relatively small group of mourners, all of whom know each other, and an unknown figure pops up, that could raise questions and perhaps inadvertently reveal to family members or friends that the deceased had a psychiatric condition and was in treatment. That needs to be taken into account as well,” he added.

In cases in which the family invites the psychiatrist, confidentiality is not a concern, and attendance by the psychiatrist is something the patient would have wanted, said Dr. Appelbaum.

How the patient died may also be factor. When a patient dies by suicide, it’s an “emotionally charged situation for both sides,” said Dr. Appelbaum.

In the case of a suicide, he noted, the deceased was often an active patient, and both the psychiatrist and the family are dealing with strong emotions – the psychiatrist with regret over loss of the patient and perhaps with questions as to what could have been done differently, and the family with sorrow but “also sometimes with suspicion or anger in that the psychiatrist somehow failed to keep the patient alive,” Dr. Appelbaum noted.

“In this situation, it’s even more crucial for the psychiatrist or other mental health professionals to take the lead from the family – perhaps to initiate contact to express condolences and inquire delicately about the funeral arrangements and whether their presence would be welcomed,” he said.

The research had no specific funding. Dr. Pettaway and Dr. Appelbaum have disclosed no relevant financial relationships.

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

Psychiatrists often develop long-term relationships with their patients, but what happens when a patient dies? Should the psychiatrist attend the patient’s funeral?

It’s a question Ashley Pettaway, MD, faced as a medical resident at the University of Alabama School of Medicine.

For 2 months, Dr. Pettaway was involved in the day-to-day care of a woman in her 40s who ultimately died. As part of that care, Dr. Pettaway had regular meetings with the patient’s husband and family members.

“The patient was about my mother’s age, so I naturally was kind of attached to her,” Dr. Pettaway told this news organization. After she died, her family invited Dr. Pettaway to the funeral.

“While I couldn’t make it to the funeral, it got me thinking. Should I go? If I go, what do I say? Who do I sit with? How do I introduce myself?” wondered Dr. Pettaway, now a resident in the department of psychiatry and neurobehavioral sciences, University of Virginia, Charlottesville.

She turned to the literature but found very little regarding psychiatrists attending their patients’ funerals. “This was surprising to me because in psychiatry, you can get so engrossed in patients’ lives,” Dr. Pettaway said.

Given the lack of rules or formal guidance on psychiatrists attending patients’ funerals, Dr. Pettaway and her mentor, Gabrielle Marzani, MD, conducted an informal survey of 12 supervising psychiatrists at the University of Virginia.

The survey results were presented at the virtual American Psychiatric Association 2021 Annual Meeting.

Ten of the 12 psychiatrists who were surveyed were caring for a patient who died while under their care. Five of those psychiatrists reported going to at least one patient’s funeral over the course of their career.

Among the psychiatrists who attended a patient’s funeral, their attendance was often based on their clinical intuition, their relationship with the family, or whether the patient was an established presence in the community. In the latter case, the psychiatrist attended as a community member.

The number of years in practice also mattered. Fewer senior faculty reported that they would be hesitant to attend and that they would not attend without a formal invitation from the family. Senior career psychiatrists were more likely to attend and felt that an invitation was not required.

None of the psychiatrists surveyed had received training or guidance on attending patients’ funerals at any point in their career.

Given the absence of formal recommendations, Dr. Pettaway believes increased conversation on this topic as part of residency training programs would help psychiatrists navigate these complex situations.
 

A complex issue

Commenting on the topic for an interview, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, said this is an “interesting and important topic that is underdiscussed.”

“I don’t think there’s a right answer that applies to every situation,” said Dr. Appelbaum, a past president of the APA.

There will be times, he said, when psychiatrists or other mental health professionals have worked closely with a patient for many years and may have interacted with the family over that period.

“When that patient passes away, they may feel, and the family may feel, that it would be comforting and appropriate for them to be at the funeral,” said Dr. Appelbaum.

However, he added, it’s important that psychiatrists “take the lead from the family.”

“There are obviously a number of complexities involved. One is how the family feels about the relationship with the psychiatrist – whether they were accepting of the reality that the patient had a mental disorder and was in treatment,” he said.

There is also the question of confidentiality, said Dr. Appelbaum.

“If it’s a large funeral and the psychiatrist is just one face in the crowd, that’s not likely to be an issue. But if it’s a relatively small group of mourners, all of whom know each other, and an unknown figure pops up, that could raise questions and perhaps inadvertently reveal to family members or friends that the deceased had a psychiatric condition and was in treatment. That needs to be taken into account as well,” he added.

In cases in which the family invites the psychiatrist, confidentiality is not a concern, and attendance by the psychiatrist is something the patient would have wanted, said Dr. Appelbaum.

How the patient died may also be factor. When a patient dies by suicide, it’s an “emotionally charged situation for both sides,” said Dr. Appelbaum.

In the case of a suicide, he noted, the deceased was often an active patient, and both the psychiatrist and the family are dealing with strong emotions – the psychiatrist with regret over loss of the patient and perhaps with questions as to what could have been done differently, and the family with sorrow but “also sometimes with suspicion or anger in that the psychiatrist somehow failed to keep the patient alive,” Dr. Appelbaum noted.

“In this situation, it’s even more crucial for the psychiatrist or other mental health professionals to take the lead from the family – perhaps to initiate contact to express condolences and inquire delicately about the funeral arrangements and whether their presence would be welcomed,” he said.

The research had no specific funding. Dr. Pettaway and Dr. Appelbaum have disclosed no relevant financial relationships.

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

Psychiatrists often develop long-term relationships with their patients, but what happens when a patient dies? Should the psychiatrist attend the patient’s funeral?

It’s a question Ashley Pettaway, MD, faced as a medical resident at the University of Alabama School of Medicine.

For 2 months, Dr. Pettaway was involved in the day-to-day care of a woman in her 40s who ultimately died. As part of that care, Dr. Pettaway had regular meetings with the patient’s husband and family members.

“The patient was about my mother’s age, so I naturally was kind of attached to her,” Dr. Pettaway told this news organization. After she died, her family invited Dr. Pettaway to the funeral.

“While I couldn’t make it to the funeral, it got me thinking. Should I go? If I go, what do I say? Who do I sit with? How do I introduce myself?” wondered Dr. Pettaway, now a resident in the department of psychiatry and neurobehavioral sciences, University of Virginia, Charlottesville.

She turned to the literature but found very little regarding psychiatrists attending their patients’ funerals. “This was surprising to me because in psychiatry, you can get so engrossed in patients’ lives,” Dr. Pettaway said.

Given the lack of rules or formal guidance on psychiatrists attending patients’ funerals, Dr. Pettaway and her mentor, Gabrielle Marzani, MD, conducted an informal survey of 12 supervising psychiatrists at the University of Virginia.

The survey results were presented at the virtual American Psychiatric Association 2021 Annual Meeting.

Ten of the 12 psychiatrists who were surveyed were caring for a patient who died while under their care. Five of those psychiatrists reported going to at least one patient’s funeral over the course of their career.

Among the psychiatrists who attended a patient’s funeral, their attendance was often based on their clinical intuition, their relationship with the family, or whether the patient was an established presence in the community. In the latter case, the psychiatrist attended as a community member.

The number of years in practice also mattered. Fewer senior faculty reported that they would be hesitant to attend and that they would not attend without a formal invitation from the family. Senior career psychiatrists were more likely to attend and felt that an invitation was not required.

None of the psychiatrists surveyed had received training or guidance on attending patients’ funerals at any point in their career.

Given the absence of formal recommendations, Dr. Pettaway believes increased conversation on this topic as part of residency training programs would help psychiatrists navigate these complex situations.
 

A complex issue

Commenting on the topic for an interview, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, said this is an “interesting and important topic that is underdiscussed.”

“I don’t think there’s a right answer that applies to every situation,” said Dr. Appelbaum, a past president of the APA.

There will be times, he said, when psychiatrists or other mental health professionals have worked closely with a patient for many years and may have interacted with the family over that period.

“When that patient passes away, they may feel, and the family may feel, that it would be comforting and appropriate for them to be at the funeral,” said Dr. Appelbaum.

However, he added, it’s important that psychiatrists “take the lead from the family.”

“There are obviously a number of complexities involved. One is how the family feels about the relationship with the psychiatrist – whether they were accepting of the reality that the patient had a mental disorder and was in treatment,” he said.

There is also the question of confidentiality, said Dr. Appelbaum.

“If it’s a large funeral and the psychiatrist is just one face in the crowd, that’s not likely to be an issue. But if it’s a relatively small group of mourners, all of whom know each other, and an unknown figure pops up, that could raise questions and perhaps inadvertently reveal to family members or friends that the deceased had a psychiatric condition and was in treatment. That needs to be taken into account as well,” he added.

In cases in which the family invites the psychiatrist, confidentiality is not a concern, and attendance by the psychiatrist is something the patient would have wanted, said Dr. Appelbaum.

How the patient died may also be factor. When a patient dies by suicide, it’s an “emotionally charged situation for both sides,” said Dr. Appelbaum.

In the case of a suicide, he noted, the deceased was often an active patient, and both the psychiatrist and the family are dealing with strong emotions – the psychiatrist with regret over loss of the patient and perhaps with questions as to what could have been done differently, and the family with sorrow but “also sometimes with suspicion or anger in that the psychiatrist somehow failed to keep the patient alive,” Dr. Appelbaum noted.

“In this situation, it’s even more crucial for the psychiatrist or other mental health professionals to take the lead from the family – perhaps to initiate contact to express condolences and inquire delicately about the funeral arrangements and whether their presence would be welcomed,” he said.

The research had no specific funding. Dr. Pettaway and Dr. Appelbaum have disclosed no relevant financial relationships.

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

An online, culturally based peer support group that uses theater and other creative outlets is helping Asian Americans cope with the COVID-19 pandemic, new research shows.

The findings of the qualitative study suggest that the program could be a model to support the mental health of other minority community groups during the COVID pandemic and beyond, say investigators from the Yale University Child Study Center, New Haven, Conn.

The Yale Compassionate Home, Action Together (CHATogether) group was created to promote emotional wellness among Asian American youth, young adults, and their families.

Early in the pandemic, it expanded its purpose to serve as a COVID-19 support group. Through social media outreach, CHATogether encourages members to cope with COVID-19 by using productive and creative outlets.

“We are a community education program serving Asian American families,” said Eunice Yuen, MD, PhD, the program’s founder and director, who is with the Yale University Child Study Center.

“We started when the pandemic began, and we realized the unique emotional distress shared among Asian American families, such as family conflict and xenophobic attacks,” said Dr. Yuen.

She discussed the program at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
 

Skits, role playing

CHATogether groups consist of people with similar experiences and challenges who support each other through weekly online group meetings, she explained.

Group members work together to create family conflict scenarios and role-play dialogues on topics amplified during the COVID-19 pandemic, such as cross-cultural challenges among Asian Americans, academic expectations in home schooling, and Black Lives Matter and LGBTQ conflicts within Asian families.

Group members create skits that are based on their personal experiences and that allow them to work through their own internal conflicts and gain a sense of agency, said Dr. Yuen.

“CHATogether is really the interface of mental health, art, and theater, and we’re trying to create a vehicle that can be a lighthearted way for people to talk about mental health, especially for Asian American families,” said Dr. Yuen.

Preliminary results from a focus group with 10 CHATogether members who joined the program since the pandemic started identified four major ways in which the program has had a positive impact on the mental health and well-being of participants:

• It provides a safe and supportive environment, strengthens bonds between members, and increases the sense of belonging, thus encouraging engagement.
• It provides structural consistency/stability through regular meetings and consistent group functions. Weekly meetings provide a sense of control and hope in the midst of uncertainty during periods of sheltering in place.
• Through adapting the group to virtual platforms, group members experience the inherent strengths of a growth mindset and cognitive flexibility when facing challenges.
• It supports healthy coping skills through sublimation and altruism.

Looking ahead, Dr. Yuen said, the team plans to investigate the validity and effectiveness of this model and to expand the group to include other minorities, school educators, and medical education for trainees and medical students.

Commenting on the program, briefing moderator Jeffrey Borenstein, MD, president and CEO of the Brain and Behavior Research Foundation and editor-in-chief of Psychiatric News, described the initiative as a “great project that serves as a model that can be used not only for Asian Americans but for other groups.

“I think the key to it is that cultural sensitivity that we need to really take into account and cultural differences among people in order to best engage them and help support them. I think this program does that beautifully,” said Dr. Borenstein.

The work was supported by the APA’s Substance Abuse and Mental Health Services Administration Minority Fellowship, which provides a 1-year fellowship to psychiatry residents committed to addressing minority psychiatric mental health issues. Dr. Yuen and Dr. Borenstein disclosed no relevant financial relationships.

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

An online, culturally based peer support group that uses theater and other creative outlets is helping Asian Americans cope with the COVID-19 pandemic, new research shows.

The findings of the qualitative study suggest that the program could be a model to support the mental health of other minority community groups during the COVID pandemic and beyond, say investigators from the Yale University Child Study Center, New Haven, Conn.

The Yale Compassionate Home, Action Together (CHATogether) group was created to promote emotional wellness among Asian American youth, young adults, and their families.

Early in the pandemic, it expanded its purpose to serve as a COVID-19 support group. Through social media outreach, CHATogether encourages members to cope with COVID-19 by using productive and creative outlets.

“We are a community education program serving Asian American families,” said Eunice Yuen, MD, PhD, the program’s founder and director, who is with the Yale University Child Study Center.

“We started when the pandemic began, and we realized the unique emotional distress shared among Asian American families, such as family conflict and xenophobic attacks,” said Dr. Yuen.

She discussed the program at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
 

Skits, role playing

CHATogether groups consist of people with similar experiences and challenges who support each other through weekly online group meetings, she explained.

Group members work together to create family conflict scenarios and role-play dialogues on topics amplified during the COVID-19 pandemic, such as cross-cultural challenges among Asian Americans, academic expectations in home schooling, and Black Lives Matter and LGBTQ conflicts within Asian families.

Group members create skits that are based on their personal experiences and that allow them to work through their own internal conflicts and gain a sense of agency, said Dr. Yuen.

“CHATogether is really the interface of mental health, art, and theater, and we’re trying to create a vehicle that can be a lighthearted way for people to talk about mental health, especially for Asian American families,” said Dr. Yuen.

Preliminary results from a focus group with 10 CHATogether members who joined the program since the pandemic started identified four major ways in which the program has had a positive impact on the mental health and well-being of participants:

• It provides a safe and supportive environment, strengthens bonds between members, and increases the sense of belonging, thus encouraging engagement.
• It provides structural consistency/stability through regular meetings and consistent group functions. Weekly meetings provide a sense of control and hope in the midst of uncertainty during periods of sheltering in place.
• Through adapting the group to virtual platforms, group members experience the inherent strengths of a growth mindset and cognitive flexibility when facing challenges.
• It supports healthy coping skills through sublimation and altruism.

Looking ahead, Dr. Yuen said, the team plans to investigate the validity and effectiveness of this model and to expand the group to include other minorities, school educators, and medical education for trainees and medical students.

Commenting on the program, briefing moderator Jeffrey Borenstein, MD, president and CEO of the Brain and Behavior Research Foundation and editor-in-chief of Psychiatric News, described the initiative as a “great project that serves as a model that can be used not only for Asian Americans but for other groups.

“I think the key to it is that cultural sensitivity that we need to really take into account and cultural differences among people in order to best engage them and help support them. I think this program does that beautifully,” said Dr. Borenstein.

The work was supported by the APA’s Substance Abuse and Mental Health Services Administration Minority Fellowship, which provides a 1-year fellowship to psychiatry residents committed to addressing minority psychiatric mental health issues. Dr. Yuen and Dr. Borenstein disclosed no relevant financial relationships.

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

An online, culturally based peer support group that uses theater and other creative outlets is helping Asian Americans cope with the COVID-19 pandemic, new research shows.

The findings of the qualitative study suggest that the program could be a model to support the mental health of other minority community groups during the COVID pandemic and beyond, say investigators from the Yale University Child Study Center, New Haven, Conn.

The Yale Compassionate Home, Action Together (CHATogether) group was created to promote emotional wellness among Asian American youth, young adults, and their families.

Early in the pandemic, it expanded its purpose to serve as a COVID-19 support group. Through social media outreach, CHATogether encourages members to cope with COVID-19 by using productive and creative outlets.

“We are a community education program serving Asian American families,” said Eunice Yuen, MD, PhD, the program’s founder and director, who is with the Yale University Child Study Center.

“We started when the pandemic began, and we realized the unique emotional distress shared among Asian American families, such as family conflict and xenophobic attacks,” said Dr. Yuen.

She discussed the program at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
 

Skits, role playing

CHATogether groups consist of people with similar experiences and challenges who support each other through weekly online group meetings, she explained.

Group members work together to create family conflict scenarios and role-play dialogues on topics amplified during the COVID-19 pandemic, such as cross-cultural challenges among Asian Americans, academic expectations in home schooling, and Black Lives Matter and LGBTQ conflicts within Asian families.

Group members create skits that are based on their personal experiences and that allow them to work through their own internal conflicts and gain a sense of agency, said Dr. Yuen.

“CHATogether is really the interface of mental health, art, and theater, and we’re trying to create a vehicle that can be a lighthearted way for people to talk about mental health, especially for Asian American families,” said Dr. Yuen.

Preliminary results from a focus group with 10 CHATogether members who joined the program since the pandemic started identified four major ways in which the program has had a positive impact on the mental health and well-being of participants:

• It provides a safe and supportive environment, strengthens bonds between members, and increases the sense of belonging, thus encouraging engagement.
• It provides structural consistency/stability through regular meetings and consistent group functions. Weekly meetings provide a sense of control and hope in the midst of uncertainty during periods of sheltering in place.
• Through adapting the group to virtual platforms, group members experience the inherent strengths of a growth mindset and cognitive flexibility when facing challenges.
• It supports healthy coping skills through sublimation and altruism.

Looking ahead, Dr. Yuen said, the team plans to investigate the validity and effectiveness of this model and to expand the group to include other minorities, school educators, and medical education for trainees and medical students.

Commenting on the program, briefing moderator Jeffrey Borenstein, MD, president and CEO of the Brain and Behavior Research Foundation and editor-in-chief of Psychiatric News, described the initiative as a “great project that serves as a model that can be used not only for Asian Americans but for other groups.

“I think the key to it is that cultural sensitivity that we need to really take into account and cultural differences among people in order to best engage them and help support them. I think this program does that beautifully,” said Dr. Borenstein.

The work was supported by the APA’s Substance Abuse and Mental Health Services Administration Minority Fellowship, which provides a 1-year fellowship to psychiatry residents committed to addressing minority psychiatric mental health issues. Dr. Yuen and Dr. Borenstein disclosed no relevant financial relationships.

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

An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
 

For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.

The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
 

Noninvasive option

Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.

“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.

The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).

Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.

Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).

PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).

Compared with placebo, significant improvement in the Clinical Global Impression–Improvement scale (CGI-I) was observed with both BXCL501 doses at 1 and 2 hours after dosing and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.

The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.

All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
 

Nipping it in the bud

SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.

Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).

Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.

BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.

“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.

“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.

Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
 

Negotiation first, medication second 

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.

“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.

“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.

He also noted that patients in the SERENITY trials had moderate to severe acute agitation.

“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.

“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.

He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.

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

An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
 

For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.

The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
 

Noninvasive option

Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.

“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.

The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).

Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.

Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).

PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).

Compared with placebo, significant improvement in the Clinical Global Impression–Improvement scale (CGI-I) was observed with both BXCL501 doses at 1 and 2 hours after dosing and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.

The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.

All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
 

Nipping it in the bud

SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.

Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).

Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.

BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.

“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.

“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.

Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
 

Negotiation first, medication second 

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.

“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.

“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.

He also noted that patients in the SERENITY trials had moderate to severe acute agitation.

“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.

“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.

He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.

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

An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
 

For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.

The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
 

Noninvasive option

Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.

“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.

The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).

Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.

Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).

PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).

Compared with placebo, significant improvement in the Clinical Global Impression–Improvement scale (CGI-I) was observed with both BXCL501 doses at 1 and 2 hours after dosing and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.

The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.

All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
 

Nipping it in the bud

SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.

Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).

Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.

BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.

“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.

“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.

Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
 

Negotiation first, medication second 

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.

“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.

“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.

He also noted that patients in the SERENITY trials had moderate to severe acute agitation.

“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.

“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.

He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.

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

Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of death or adverse cardiovascular events, compared with standard hospital food, new research indicates.
 

The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index, weight loss, and low food intake upon hospital admission.

“This high-risk group of chronic heart failure patients showed a significant improvement in mortality over 30 and 180 days, as well as other clinical outcomes, when individualized nutritional support interventions were offered to patients,” Philipp Schuetz, MD, MPH, Kantonsspital Aarau, Switzerland, said in an interview.

“While monitoring the nutritional status should be done also in outpatient settings by [general practitioners], malnutrition screening upon hospital admission may help to identify high-risk patients with high risk for nutritional status deterioration during the hospital stay who will benefit from nutritional assessment and treatment,” said Dr. Schuetz.

The study was published online May 3 in the Journal of the American College of Cardiology.
 

It’s not all about salt

The findings are based on a prespecified secondary analysis of outcomes in 645 patients (median age, 78.8 years, 52% men) hospitalized with chronic heart failure who participated in the open-label EFFORT study.  

One-third of patients were hospitalized for acute decompensated heart failure and two-thirds had chronic heart failure and other acute medical illnesses requiring hospitalization.

All patients were at risk of malnutrition based on a Nutritional Risk Screening (NRS) score of 3 points or higher. They were randomly allocated 1:1 to individualized nutritional support to reach energy, protein, and micronutrient goals or usual hospital food (control group). 

By 30 days, 27 of 321 patients (8.4%) receiving nutritional support had died compared with 48 of 324 patients (14.8%) in the control group (adjusted odds ratio [OR]: 0.44; 95% confidence interval, 0.26-0.75; P = .002)

Patients with high nutritional risk (NRS >4 points) showed the most benefit from nutritional support.

Compared with patients with moderate nutritional risk scores (NRS score 3-4), those with high nutritional risk (NRS >4) had a highly significant 65% increased mortality risk over 180 days.

The individual component of the NRS with the strongest association with mortality was low food intake in the week before hospitalization.

Patients who received nutritional support in the hospital also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; OR, 0.50; 95% CI, 0.34-0.75; P = .001).

“Historically, cardiologists and internists caring for patients with heart failure have mainly focused on salt-restrictive diets to reduce blood volume and thus optimize heart function. Yet, reduction of salt intake has not been shown to effectively improve clinical outcome but may, on the contrary, increase the risk of malnutrition as low-salt diets are often not tasty,” Dr. Schuetz said.

“Our data suggest that we should move our focus away from salt-restrictive diets to high-protein diets to cover individual nutritional goals in this high-risk group of patients, which includes screening, assessment, and nutritional support by dietitians,” Dr. Schuetz said.

In a linked editorial, Sheldon Gottlieb, MD, Johns Hopkins University, Baltimore, said there has been “relatively little attention” paid to the role of diet in heart failure other than recommending reduced salt intake. 

In fact, in the 2021 American College of Cardiology expert consensus recommendations for optimizing heart failure treatment, roughly five words are devoted to diet and exercise and there is no mention of nutrition assessment by a dietitian, he points out.

“This study adds another tile to the still-fragmentary mosaic picture of the patient with heart failure at nutritional risk who might benefit from nutritional support,” Dr. Dr. Gottlieb wrote.

“ ‘Good medical care’ dictates that all hospitalized patients deserve to have a standardized nutritional assessment; the challenge remains: how to determine which patient with heart failure at nutritional risk will benefit by medical nutrition therapy,” Dr. Gottlieb said.

The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau provided funding for the trial. Dr. Schuetz’s institution has previously received unrestricted grant money unrelated to this project from Nestle Health Science and Abbott Nutrition. Dr. Gottlieb owns a federal trademark for the “Greens, Beans, and Leans” diet, and has a pending federal trademark for “FLOATS”: flax + oats cereal.

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

Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of death or adverse cardiovascular events, compared with standard hospital food, new research indicates.
 

The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index, weight loss, and low food intake upon hospital admission.

“This high-risk group of chronic heart failure patients showed a significant improvement in mortality over 30 and 180 days, as well as other clinical outcomes, when individualized nutritional support interventions were offered to patients,” Philipp Schuetz, MD, MPH, Kantonsspital Aarau, Switzerland, said in an interview.

“While monitoring the nutritional status should be done also in outpatient settings by [general practitioners], malnutrition screening upon hospital admission may help to identify high-risk patients with high risk for nutritional status deterioration during the hospital stay who will benefit from nutritional assessment and treatment,” said Dr. Schuetz.

The study was published online May 3 in the Journal of the American College of Cardiology.
 

It’s not all about salt

The findings are based on a prespecified secondary analysis of outcomes in 645 patients (median age, 78.8 years, 52% men) hospitalized with chronic heart failure who participated in the open-label EFFORT study.  

One-third of patients were hospitalized for acute decompensated heart failure and two-thirds had chronic heart failure and other acute medical illnesses requiring hospitalization.

All patients were at risk of malnutrition based on a Nutritional Risk Screening (NRS) score of 3 points or higher. They were randomly allocated 1:1 to individualized nutritional support to reach energy, protein, and micronutrient goals or usual hospital food (control group). 

By 30 days, 27 of 321 patients (8.4%) receiving nutritional support had died compared with 48 of 324 patients (14.8%) in the control group (adjusted odds ratio [OR]: 0.44; 95% confidence interval, 0.26-0.75; P = .002)

Patients with high nutritional risk (NRS >4 points) showed the most benefit from nutritional support.

Compared with patients with moderate nutritional risk scores (NRS score 3-4), those with high nutritional risk (NRS >4) had a highly significant 65% increased mortality risk over 180 days.

The individual component of the NRS with the strongest association with mortality was low food intake in the week before hospitalization.

Patients who received nutritional support in the hospital also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; OR, 0.50; 95% CI, 0.34-0.75; P = .001).

“Historically, cardiologists and internists caring for patients with heart failure have mainly focused on salt-restrictive diets to reduce blood volume and thus optimize heart function. Yet, reduction of salt intake has not been shown to effectively improve clinical outcome but may, on the contrary, increase the risk of malnutrition as low-salt diets are often not tasty,” Dr. Schuetz said.

“Our data suggest that we should move our focus away from salt-restrictive diets to high-protein diets to cover individual nutritional goals in this high-risk group of patients, which includes screening, assessment, and nutritional support by dietitians,” Dr. Schuetz said.

In a linked editorial, Sheldon Gottlieb, MD, Johns Hopkins University, Baltimore, said there has been “relatively little attention” paid to the role of diet in heart failure other than recommending reduced salt intake. 

In fact, in the 2021 American College of Cardiology expert consensus recommendations for optimizing heart failure treatment, roughly five words are devoted to diet and exercise and there is no mention of nutrition assessment by a dietitian, he points out.

“This study adds another tile to the still-fragmentary mosaic picture of the patient with heart failure at nutritional risk who might benefit from nutritional support,” Dr. Dr. Gottlieb wrote.

“ ‘Good medical care’ dictates that all hospitalized patients deserve to have a standardized nutritional assessment; the challenge remains: how to determine which patient with heart failure at nutritional risk will benefit by medical nutrition therapy,” Dr. Gottlieb said.

The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau provided funding for the trial. Dr. Schuetz’s institution has previously received unrestricted grant money unrelated to this project from Nestle Health Science and Abbott Nutrition. Dr. Gottlieb owns a federal trademark for the “Greens, Beans, and Leans” diet, and has a pending federal trademark for “FLOATS”: flax + oats cereal.

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

Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of death or adverse cardiovascular events, compared with standard hospital food, new research indicates.
 

The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index, weight loss, and low food intake upon hospital admission.

“This high-risk group of chronic heart failure patients showed a significant improvement in mortality over 30 and 180 days, as well as other clinical outcomes, when individualized nutritional support interventions were offered to patients,” Philipp Schuetz, MD, MPH, Kantonsspital Aarau, Switzerland, said in an interview.

“While monitoring the nutritional status should be done also in outpatient settings by [general practitioners], malnutrition screening upon hospital admission may help to identify high-risk patients with high risk for nutritional status deterioration during the hospital stay who will benefit from nutritional assessment and treatment,” said Dr. Schuetz.

The study was published online May 3 in the Journal of the American College of Cardiology.
 

It’s not all about salt

The findings are based on a prespecified secondary analysis of outcomes in 645 patients (median age, 78.8 years, 52% men) hospitalized with chronic heart failure who participated in the open-label EFFORT study.  

One-third of patients were hospitalized for acute decompensated heart failure and two-thirds had chronic heart failure and other acute medical illnesses requiring hospitalization.

All patients were at risk of malnutrition based on a Nutritional Risk Screening (NRS) score of 3 points or higher. They were randomly allocated 1:1 to individualized nutritional support to reach energy, protein, and micronutrient goals or usual hospital food (control group). 

By 30 days, 27 of 321 patients (8.4%) receiving nutritional support had died compared with 48 of 324 patients (14.8%) in the control group (adjusted odds ratio [OR]: 0.44; 95% confidence interval, 0.26-0.75; P = .002)

Patients with high nutritional risk (NRS >4 points) showed the most benefit from nutritional support.

Compared with patients with moderate nutritional risk scores (NRS score 3-4), those with high nutritional risk (NRS >4) had a highly significant 65% increased mortality risk over 180 days.

The individual component of the NRS with the strongest association with mortality was low food intake in the week before hospitalization.

Patients who received nutritional support in the hospital also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; OR, 0.50; 95% CI, 0.34-0.75; P = .001).

“Historically, cardiologists and internists caring for patients with heart failure have mainly focused on salt-restrictive diets to reduce blood volume and thus optimize heart function. Yet, reduction of salt intake has not been shown to effectively improve clinical outcome but may, on the contrary, increase the risk of malnutrition as low-salt diets are often not tasty,” Dr. Schuetz said.

“Our data suggest that we should move our focus away from salt-restrictive diets to high-protein diets to cover individual nutritional goals in this high-risk group of patients, which includes screening, assessment, and nutritional support by dietitians,” Dr. Schuetz said.

In a linked editorial, Sheldon Gottlieb, MD, Johns Hopkins University, Baltimore, said there has been “relatively little attention” paid to the role of diet in heart failure other than recommending reduced salt intake. 

In fact, in the 2021 American College of Cardiology expert consensus recommendations for optimizing heart failure treatment, roughly five words are devoted to diet and exercise and there is no mention of nutrition assessment by a dietitian, he points out.

“This study adds another tile to the still-fragmentary mosaic picture of the patient with heart failure at nutritional risk who might benefit from nutritional support,” Dr. Dr. Gottlieb wrote.

“ ‘Good medical care’ dictates that all hospitalized patients deserve to have a standardized nutritional assessment; the challenge remains: how to determine which patient with heart failure at nutritional risk will benefit by medical nutrition therapy,” Dr. Gottlieb said.

The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau provided funding for the trial. Dr. Schuetz’s institution has previously received unrestricted grant money unrelated to this project from Nestle Health Science and Abbott Nutrition. Dr. Gottlieb owns a federal trademark for the “Greens, Beans, and Leans” diet, and has a pending federal trademark for “FLOATS”: flax + oats cereal.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

“One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

“One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

“One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.

The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.

Serious mental health hit

In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.

Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.

The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%). 

Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).

In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.

Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).

The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.

Call to action

More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.

More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.

Nearly half (49%) of parents of children younger than 18 years say their child received help from a mental health professional since the start of the pandemic; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.

More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.

“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.

“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.

Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.

For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).

Resiliency a finite resource

Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.

“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.

He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.

“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.

The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.

“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.

“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.

While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.

“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.

“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.

“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.

Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.

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

Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.

The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.

Serious mental health hit

In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.

Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.

The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%). 

Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).

In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.

Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).

The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.

Call to action

More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.

More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.

Nearly half (49%) of parents of children younger than 18 years say their child received help from a mental health professional since the start of the pandemic; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.

More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.

“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.

“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.

Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.

For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).

Resiliency a finite resource

Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.

“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.

He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.

“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.

The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.

“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.

“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.

While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.

“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.

“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.

“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.

Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.

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

Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.

The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.

Serious mental health hit

In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.

Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.

The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%). 

Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).

In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.

Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).

The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.

Call to action

More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.

More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.

Nearly half (49%) of parents of children younger than 18 years say their child received help from a mental health professional since the start of the pandemic; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.

More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.

“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.

“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.

Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.

For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).

Resiliency a finite resource

Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.

“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.

He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.

“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.

The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.

“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.

“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.

While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.

“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.

“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.

“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.

Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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