Nearly 1 in 8 households—and 1 in 6 households with children—experienced food insecurity in 2017, defined as limited or uncertain availability of nutritionally adequate and safe foods.¹ Food insecurity is often even more pronounced among households with individuals with acute or chronic medical conditions.^2-6 Moreover, food insecurity is independently associated with a range of adverse health outcomes, including poorer control of diabetes mellitus, hypertension, depression and other major psychiatric disorders, HIV, and chronic lung and kidney disease, as well as poorer overall health status.^7-14 Food insecurity also has been associated with increased health care costs and acute care utilization as well as increased probability of delayed or missed care.^15-19

The relationship between food insecurity and poor health outcomes is a complex and often cyclic phenomenon (Figure 1). Poor nutritional status is fueled by limited access to healthful foods as well as increased reliance on calorie-dense and nutrient-poor “junk” foods, which are less expensive and often more readily available in low-income neighborhoods.^5,20-24 These compensatory dietary patterns place individuals at higher risk for developing cardiometabolic conditions and for poor control of these conditions.^{5,8,9,12,25,26} Additionally, the physiological and psychological stressors of food insecurity may precipitate depression and anxiety or worsen existing mental health conditions, resulting in feelings of overwhelm and decreased self-management capacity.^5,8,27-31 Food insecurity has further been associated with poor sleep, declines in cognitive function, and increased falls, particularly among the frail and elderly.^32-34

Prevalence and Importance of Food Insecurity Among US Veterans

Nearly 1.5 million veterans in the US are living below the federal poverty level (FPL).³⁹ An additional 2.4 million veterans are living paycheck to paycheck at < 200% of the FPL.⁴⁰ Veterans living in poverty are at even higher risk than nonveterans for food insecurity, homelessness, and other material hardship.⁴¹

Estimates of food insecurity among veterans vary widely, ranging from 6% to 24%—nearly twice that of the general US population.^8,42-45 Higher rates of food insecurity have been reported among certain high-risk subgroups, including veterans who served in Iraq and Afghanistan (27%), female veterans (28%), homeless and formerly homeless veterans (49%), and veterans with serious mental illness (35%).^6,32,43,46 Additional risk factors for food insecurity specific to veteran populations include younger age, having recently left active-duty military service, and lower final military paygrade.^42,45-47 As in the general population, veteran food insecurity is associated with a range of adverse health outcomes, including poorer overall health status as well as increased probability of delayed or missed care.^{6,8,32,42-44,46}

Even among veterans enrolled in federal food assistance programs, many still struggle to afford nutritionally adequate foods. As one example, in a study of mostly male homeless and formerly homeless veterans, O’Toole and colleagues found that nearly half of those reporting food insecurity were already receiving federal food assistance benefits, and 22% relied on emergency food resources.³² Of households served by Feeding America food pantries and meal programs, 20% have a member who has served in the US military.⁴⁸

Federal Programs To Address Food Insecurity

There are several important federal food assistance programs designed to help alleviate food insecurity. The Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp program) is the largest federal food assistance program and provides low-income Americans with cash benefits to purchase food. SNAP has been shown to substantially reduce food insecurity.^7,49 The program also is associated with significant decreases in cost-related medication nonadherence as well as reductions in health care costs and both acute care and nursing home utilization.^16,50-54 Although nearly 1.4 million veterans live in SNAP-enrolled households, 59% of eligible veterans are not enrolled.^43,55 Closing this SNAP eligibility-enrollment gap, has been a focus of recent efforts to improve long-term food security among veterans. There also are several federal food assistance programs for households with children, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. Among federal nutrition programs for seniors, the Older American’s Act contains designated funding to support nutrition services for older adults, including congregate meal programs in community settings like senior centers, places of worship, and housing communities, and home-delivered meals through programs like Meals on Wheels.⁵⁶

VHA Response to Food Insecurity

The Veterans Health Administration (VHA) is the country’s largest integrated, federally funded health care system.⁵⁷ In November 2015, congressional briefings on veteran food insecurity organized by the national non-profit organization MAZON: A Jewish Response to Hunger and hosted with bipartisan support were provided to the US House and Senate. As a result of these briefings, VHA chartered the national Ensuring Veteran Food Security Workgroup with a mandate to partner with governmental and nonprofit agencies to “focus on the issue of food insecurity, the identification of veterans at risk, the needed training of VHA staff and the coordination of resources and initiatives to support the veterans for whom we care.” Building off a pilot in US Department of Veterans Affairs (VA) Homeless Patient Aligned Care Teams (H-PACTs),³² VHA subsequently integrated a single-item food insecurity screening tool into the VA electronic health record (EHR) clinical reminder system (Figure 2). The clinical reminder, which was rolled out across VA medical centers nationally in October 2017, provides an alert to screen all noninstitutionalized veterans for food insecurity. To date, nearly 5 million veterans have been screened. When a veteran endorses food insecurity based on the initial screening question, a prompt appears to offer the veteran a referral to a social worker and/or dietitian. Positive screening results also should be communicated to the patient’s primary care provider. Depending on site-specific clinical flow, the reminders are typically completed in the outpatient setting either by nurses or medical assistants during intake or by providers as part of the clinical visit. However, any member of the health care team can complete the clinical reminder at any time. As of September 2019, approximately 74,000 veterans have been identified as food insecure.⁵⁸

Addressing Food Insecurity

VHA has been a recognized leader in addressing homelessness and other social determinants of health through its integrated care and PACT delivery models.^59-61 The food insecurity clinical reminder was designed to facilitate a tailored, interdisciplinary approach to identify and address food insecurity. Interdisciplinary care team members—including medical assistants, clinicians, social workers, registered dietitians, nurse care managers, occupational or physical therapists, and pharmacists—are uniquely positioned to identify veterans impacted by food insecurity, assess for associated clinical and/or social risk factors, and offer appropriate medical and nutrition interventions and resource referrals.

This interdisciplinary team-based model is essential given the range of potential drivers underlying veteran experiences of food insecurity and subsequent health outcomes. It is critically important for clinicians to review the medication list with veterans screening positive for food insecurity to assess for risk of hypoglycemia and/or cost-related nonadherence, make any necessary adjustments to therapeutic regimens, and assess for additional risk factors associated with food insecurity. Examples of tailored nutrition counseling that clinical dietitians may provide include meal preparation strategies for veterans who only have access to a microwave or hotplate, or recommendations for how veterans on medically restricted diets can best navigate food selection at soup kitchens or food pantries. Resource referrals provided by social workers or other care team members may include both emergency food resources to address immediate shortages (eg, food pantries, soup kitchens, or vouchers for free lunch) as well as resources focused on improving longer term food security (eg, federal food assistance programs or home delivered meal programs). Importantly, although providing a list of food resources may be helpful for some patients, such lists are often insufficient.^62,63 Many patients require active assistance with program enrollment either onsite the day of their clinic visit or through connection with a partnering community-based organization that can, in turn, identify appropriate resources and facilitate program enrollment.^63,64 Planned follow-up is also crucial to determine whether referrals are successful and to assess for ongoing need. Proposed roles for interdisciplinary care team members in addressing a positive food insecurity screen are outlined in Table 1.

VHA-Community Partnerships

In addition to services offered within VA, public and private sector partnerships can greatly enhance the range of resources available to food insecure veterans. Several VA facilities have developed formal community partnerships, such as the Veterans Pantry Pilot (VPP) program, a national partnership between Feeding America food banks and VA medical centers to establish onsite or mobile food pantries. There are currently 17 active Feeding America VPP sites, with a number of additional sites under development. Several of the VPP sites also include other “wraparound services,” such as SNAP application assistance.^65,66

State Veterans Affairs offices⁶⁷ and Veterans Service Organizations (VSOs)⁶⁸ also can serve as valuable partners for connecting veterans with needed resources. VSOs offer a range of services, including assistancewith benefit claims, employment and housing assistance, emergency food assistance, and transportation to medical appointments. Some VSOs also have established local affiliations with Meals on Wheels focused on veteran outreach and providing hot meals for low-income, homebound, and disabled veterans.

Additional Resources

Although resources vary by regional setting, several key governmental and community-based food assistance programs are summarized in Table 2. Local community partners and online/phone-based directories, such as United Way’s 2-1-1 can help identify additional local resources. For older adults and individuals with disabilities, local Aging and Disability Resources Centers can provide information and assistance connecting to needed resources.⁶⁹ Finally, there are a number of online resources available for clinicians interested in learning more about the impact of food insecurity on health and tools to use in the clinical setting (Table 3).

Conclusion

The VA has recognized food insecurity as a critical concern for the well-being of our nation’s veterans. Use of the EHR clinical reminder represents a crucial first step toward increasing provider awareness about veteran food insecurity and improving clinical efforts to address food insecurity once identified. Through the reminder, health care teams can connect veterans to needed resources and create both the individual and population-level data necessary to inform VHA and community efforts to address veteran food insecurity. Clinical reminder data are currently being used for local quality improvement efforts and have established the need nationally for formalized partnerships between VHA Social Work Services and Nutrition and Food Services to connect veterans with food and provide them with strategies to best use available food resources.

Moving forward, the Ensuring Veteran Food Security Workgroup continues to work with agencies and organizations across the country to improve food insecure veterans’ access to needed services. In addition to existing VA partnerships with Feeding America for the VPP, memorandums of understanding are currently underway to formalize partnerships with both the Food Research and Action Center (FRAC) and MAZON. Additional research is needed both to formally validate the current food insecurity clinical reminder screening question and to identify best practices and potential models for how to most effectively use VHA-community partnerships to address the unique needs of the veteran population.

Ensuring the food security of our nation’s veterans is essential to VA’s commitment to providing integrated, veteran-centered, whole person care. Toward that goal, VA health care teams are urged to use the clinical reminder and help connect food insecure veterans with relevant resources both within and outside of the VA health care system.

Nearly 1 in 8 households—and 1 in 6 households with children—experienced food insecurity in 2017, defined as limited or uncertain availability of nutritionally adequate and safe foods.¹ Food insecurity is often even more pronounced among households with individuals with acute or chronic medical conditions.^2-6 Moreover, food insecurity is independently associated with a range of adverse health outcomes, including poorer control of diabetes mellitus, hypertension, depression and other major psychiatric disorders, HIV, and chronic lung and kidney disease, as well as poorer overall health status.^7-14 Food insecurity also has been associated with increased health care costs and acute care utilization as well as increased probability of delayed or missed care.^15-19

The relationship between food insecurity and poor health outcomes is a complex and often cyclic phenomenon (Figure 1). Poor nutritional status is fueled by limited access to healthful foods as well as increased reliance on calorie-dense and nutrient-poor “junk” foods, which are less expensive and often more readily available in low-income neighborhoods.^5,20-24 These compensatory dietary patterns place individuals at higher risk for developing cardiometabolic conditions and for poor control of these conditions.^{5,8,9,12,25,26} Additionally, the physiological and psychological stressors of food insecurity may precipitate depression and anxiety or worsen existing mental health conditions, resulting in feelings of overwhelm and decreased self-management capacity.^5,8,27-31 Food insecurity has further been associated with poor sleep, declines in cognitive function, and increased falls, particularly among the frail and elderly.^32-34

Prevalence and Importance of Food Insecurity Among US Veterans

Nearly 1.5 million veterans in the US are living below the federal poverty level (FPL).³⁹ An additional 2.4 million veterans are living paycheck to paycheck at < 200% of the FPL.⁴⁰ Veterans living in poverty are at even higher risk than nonveterans for food insecurity, homelessness, and other material hardship.⁴¹

Estimates of food insecurity among veterans vary widely, ranging from 6% to 24%—nearly twice that of the general US population.^8,42-45 Higher rates of food insecurity have been reported among certain high-risk subgroups, including veterans who served in Iraq and Afghanistan (27%), female veterans (28%), homeless and formerly homeless veterans (49%), and veterans with serious mental illness (35%).^6,32,43,46 Additional risk factors for food insecurity specific to veteran populations include younger age, having recently left active-duty military service, and lower final military paygrade.^42,45-47 As in the general population, veteran food insecurity is associated with a range of adverse health outcomes, including poorer overall health status as well as increased probability of delayed or missed care.^{6,8,32,42-44,46}

Even among veterans enrolled in federal food assistance programs, many still struggle to afford nutritionally adequate foods. As one example, in a study of mostly male homeless and formerly homeless veterans, O’Toole and colleagues found that nearly half of those reporting food insecurity were already receiving federal food assistance benefits, and 22% relied on emergency food resources.³² Of households served by Feeding America food pantries and meal programs, 20% have a member who has served in the US military.⁴⁸

Federal Programs To Address Food Insecurity

There are several important federal food assistance programs designed to help alleviate food insecurity. The Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp program) is the largest federal food assistance program and provides low-income Americans with cash benefits to purchase food. SNAP has been shown to substantially reduce food insecurity.^7,49 The program also is associated with significant decreases in cost-related medication nonadherence as well as reductions in health care costs and both acute care and nursing home utilization.^16,50-54 Although nearly 1.4 million veterans live in SNAP-enrolled households, 59% of eligible veterans are not enrolled.^43,55 Closing this SNAP eligibility-enrollment gap, has been a focus of recent efforts to improve long-term food security among veterans. There also are several federal food assistance programs for households with children, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. Among federal nutrition programs for seniors, the Older American’s Act contains designated funding to support nutrition services for older adults, including congregate meal programs in community settings like senior centers, places of worship, and housing communities, and home-delivered meals through programs like Meals on Wheels.⁵⁶

VHA Response to Food Insecurity

The Veterans Health Administration (VHA) is the country’s largest integrated, federally funded health care system.⁵⁷ In November 2015, congressional briefings on veteran food insecurity organized by the national non-profit organization MAZON: A Jewish Response to Hunger and hosted with bipartisan support were provided to the US House and Senate. As a result of these briefings, VHA chartered the national Ensuring Veteran Food Security Workgroup with a mandate to partner with governmental and nonprofit agencies to “focus on the issue of food insecurity, the identification of veterans at risk, the needed training of VHA staff and the coordination of resources and initiatives to support the veterans for whom we care.” Building off a pilot in US Department of Veterans Affairs (VA) Homeless Patient Aligned Care Teams (H-PACTs),³² VHA subsequently integrated a single-item food insecurity screening tool into the VA electronic health record (EHR) clinical reminder system (Figure 2). The clinical reminder, which was rolled out across VA medical centers nationally in October 2017, provides an alert to screen all noninstitutionalized veterans for food insecurity. To date, nearly 5 million veterans have been screened. When a veteran endorses food insecurity based on the initial screening question, a prompt appears to offer the veteran a referral to a social worker and/or dietitian. Positive screening results also should be communicated to the patient’s primary care provider. Depending on site-specific clinical flow, the reminders are typically completed in the outpatient setting either by nurses or medical assistants during intake or by providers as part of the clinical visit. However, any member of the health care team can complete the clinical reminder at any time. As of September 2019, approximately 74,000 veterans have been identified as food insecure.⁵⁸

Addressing Food Insecurity

VHA has been a recognized leader in addressing homelessness and other social determinants of health through its integrated care and PACT delivery models.^59-61 The food insecurity clinical reminder was designed to facilitate a tailored, interdisciplinary approach to identify and address food insecurity. Interdisciplinary care team members—including medical assistants, clinicians, social workers, registered dietitians, nurse care managers, occupational or physical therapists, and pharmacists—are uniquely positioned to identify veterans impacted by food insecurity, assess for associated clinical and/or social risk factors, and offer appropriate medical and nutrition interventions and resource referrals.

This interdisciplinary team-based model is essential given the range of potential drivers underlying veteran experiences of food insecurity and subsequent health outcomes. It is critically important for clinicians to review the medication list with veterans screening positive for food insecurity to assess for risk of hypoglycemia and/or cost-related nonadherence, make any necessary adjustments to therapeutic regimens, and assess for additional risk factors associated with food insecurity. Examples of tailored nutrition counseling that clinical dietitians may provide include meal preparation strategies for veterans who only have access to a microwave or hotplate, or recommendations for how veterans on medically restricted diets can best navigate food selection at soup kitchens or food pantries. Resource referrals provided by social workers or other care team members may include both emergency food resources to address immediate shortages (eg, food pantries, soup kitchens, or vouchers for free lunch) as well as resources focused on improving longer term food security (eg, federal food assistance programs or home delivered meal programs). Importantly, although providing a list of food resources may be helpful for some patients, such lists are often insufficient.^62,63 Many patients require active assistance with program enrollment either onsite the day of their clinic visit or through connection with a partnering community-based organization that can, in turn, identify appropriate resources and facilitate program enrollment.^63,64 Planned follow-up is also crucial to determine whether referrals are successful and to assess for ongoing need. Proposed roles for interdisciplinary care team members in addressing a positive food insecurity screen are outlined in Table 1.

VHA-Community Partnerships

In addition to services offered within VA, public and private sector partnerships can greatly enhance the range of resources available to food insecure veterans. Several VA facilities have developed formal community partnerships, such as the Veterans Pantry Pilot (VPP) program, a national partnership between Feeding America food banks and VA medical centers to establish onsite or mobile food pantries. There are currently 17 active Feeding America VPP sites, with a number of additional sites under development. Several of the VPP sites also include other “wraparound services,” such as SNAP application assistance.^65,66

State Veterans Affairs offices⁶⁷ and Veterans Service Organizations (VSOs)⁶⁸ also can serve as valuable partners for connecting veterans with needed resources. VSOs offer a range of services, including assistancewith benefit claims, employment and housing assistance, emergency food assistance, and transportation to medical appointments. Some VSOs also have established local affiliations with Meals on Wheels focused on veteran outreach and providing hot meals for low-income, homebound, and disabled veterans.

Additional Resources

Although resources vary by regional setting, several key governmental and community-based food assistance programs are summarized in Table 2. Local community partners and online/phone-based directories, such as United Way’s 2-1-1 can help identify additional local resources. For older adults and individuals with disabilities, local Aging and Disability Resources Centers can provide information and assistance connecting to needed resources.⁶⁹ Finally, there are a number of online resources available for clinicians interested in learning more about the impact of food insecurity on health and tools to use in the clinical setting (Table 3).

Conclusion

The VA has recognized food insecurity as a critical concern for the well-being of our nation’s veterans. Use of the EHR clinical reminder represents a crucial first step toward increasing provider awareness about veteran food insecurity and improving clinical efforts to address food insecurity once identified. Through the reminder, health care teams can connect veterans to needed resources and create both the individual and population-level data necessary to inform VHA and community efforts to address veteran food insecurity. Clinical reminder data are currently being used for local quality improvement efforts and have established the need nationally for formalized partnerships between VHA Social Work Services and Nutrition and Food Services to connect veterans with food and provide them with strategies to best use available food resources.

Moving forward, the Ensuring Veteran Food Security Workgroup continues to work with agencies and organizations across the country to improve food insecure veterans’ access to needed services. In addition to existing VA partnerships with Feeding America for the VPP, memorandums of understanding are currently underway to formalize partnerships with both the Food Research and Action Center (FRAC) and MAZON. Additional research is needed both to formally validate the current food insecurity clinical reminder screening question and to identify best practices and potential models for how to most effectively use VHA-community partnerships to address the unique needs of the veteran population.

Ensuring the food security of our nation’s veterans is essential to VA’s commitment to providing integrated, veteran-centered, whole person care. Toward that goal, VA health care teams are urged to use the clinical reminder and help connect food insecure veterans with relevant resources both within and outside of the VA health care system.

Nearly 1 in 8 households—and 1 in 6 households with children—experienced food insecurity in 2017, defined as limited or uncertain availability of nutritionally adequate and safe foods.¹ Food insecurity is often even more pronounced among households with individuals with acute or chronic medical conditions.^2-6 Moreover, food insecurity is independently associated with a range of adverse health outcomes, including poorer control of diabetes mellitus, hypertension, depression and other major psychiatric disorders, HIV, and chronic lung and kidney disease, as well as poorer overall health status.^7-14 Food insecurity also has been associated with increased health care costs and acute care utilization as well as increased probability of delayed or missed care.^15-19

The relationship between food insecurity and poor health outcomes is a complex and often cyclic phenomenon (Figure 1). Poor nutritional status is fueled by limited access to healthful foods as well as increased reliance on calorie-dense and nutrient-poor “junk” foods, which are less expensive and often more readily available in low-income neighborhoods.^5,20-24 These compensatory dietary patterns place individuals at higher risk for developing cardiometabolic conditions and for poor control of these conditions.^{5,8,9,12,25,26} Additionally, the physiological and psychological stressors of food insecurity may precipitate depression and anxiety or worsen existing mental health conditions, resulting in feelings of overwhelm and decreased self-management capacity.^5,8,27-31 Food insecurity has further been associated with poor sleep, declines in cognitive function, and increased falls, particularly among the frail and elderly.^32-34

Prevalence and Importance of Food Insecurity Among US Veterans

Nearly 1.5 million veterans in the US are living below the federal poverty level (FPL).³⁹ An additional 2.4 million veterans are living paycheck to paycheck at < 200% of the FPL.⁴⁰ Veterans living in poverty are at even higher risk than nonveterans for food insecurity, homelessness, and other material hardship.⁴¹

Estimates of food insecurity among veterans vary widely, ranging from 6% to 24%—nearly twice that of the general US population.^8,42-45 Higher rates of food insecurity have been reported among certain high-risk subgroups, including veterans who served in Iraq and Afghanistan (27%), female veterans (28%), homeless and formerly homeless veterans (49%), and veterans with serious mental illness (35%).^6,32,43,46 Additional risk factors for food insecurity specific to veteran populations include younger age, having recently left active-duty military service, and lower final military paygrade.^42,45-47 As in the general population, veteran food insecurity is associated with a range of adverse health outcomes, including poorer overall health status as well as increased probability of delayed or missed care.^{6,8,32,42-44,46}

Even among veterans enrolled in federal food assistance programs, many still struggle to afford nutritionally adequate foods. As one example, in a study of mostly male homeless and formerly homeless veterans, O’Toole and colleagues found that nearly half of those reporting food insecurity were already receiving federal food assistance benefits, and 22% relied on emergency food resources.³² Of households served by Feeding America food pantries and meal programs, 20% have a member who has served in the US military.⁴⁸

Federal Programs To Address Food Insecurity

There are several important federal food assistance programs designed to help alleviate food insecurity. The Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp program) is the largest federal food assistance program and provides low-income Americans with cash benefits to purchase food. SNAP has been shown to substantially reduce food insecurity.^7,49 The program also is associated with significant decreases in cost-related medication nonadherence as well as reductions in health care costs and both acute care and nursing home utilization.^16,50-54 Although nearly 1.4 million veterans live in SNAP-enrolled households, 59% of eligible veterans are not enrolled.^43,55 Closing this SNAP eligibility-enrollment gap, has been a focus of recent efforts to improve long-term food security among veterans. There also are several federal food assistance programs for households with children, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. Among federal nutrition programs for seniors, the Older American’s Act contains designated funding to support nutrition services for older adults, including congregate meal programs in community settings like senior centers, places of worship, and housing communities, and home-delivered meals through programs like Meals on Wheels.⁵⁶

VHA Response to Food Insecurity

The Veterans Health Administration (VHA) is the country’s largest integrated, federally funded health care system.⁵⁷ In November 2015, congressional briefings on veteran food insecurity organized by the national non-profit organization MAZON: A Jewish Response to Hunger and hosted with bipartisan support were provided to the US House and Senate. As a result of these briefings, VHA chartered the national Ensuring Veteran Food Security Workgroup with a mandate to partner with governmental and nonprofit agencies to “focus on the issue of food insecurity, the identification of veterans at risk, the needed training of VHA staff and the coordination of resources and initiatives to support the veterans for whom we care.” Building off a pilot in US Department of Veterans Affairs (VA) Homeless Patient Aligned Care Teams (H-PACTs),³² VHA subsequently integrated a single-item food insecurity screening tool into the VA electronic health record (EHR) clinical reminder system (Figure 2). The clinical reminder, which was rolled out across VA medical centers nationally in October 2017, provides an alert to screen all noninstitutionalized veterans for food insecurity. To date, nearly 5 million veterans have been screened. When a veteran endorses food insecurity based on the initial screening question, a prompt appears to offer the veteran a referral to a social worker and/or dietitian. Positive screening results also should be communicated to the patient’s primary care provider. Depending on site-specific clinical flow, the reminders are typically completed in the outpatient setting either by nurses or medical assistants during intake or by providers as part of the clinical visit. However, any member of the health care team can complete the clinical reminder at any time. As of September 2019, approximately 74,000 veterans have been identified as food insecure.⁵⁸

Addressing Food Insecurity

VHA has been a recognized leader in addressing homelessness and other social determinants of health through its integrated care and PACT delivery models.^59-61 The food insecurity clinical reminder was designed to facilitate a tailored, interdisciplinary approach to identify and address food insecurity. Interdisciplinary care team members—including medical assistants, clinicians, social workers, registered dietitians, nurse care managers, occupational or physical therapists, and pharmacists—are uniquely positioned to identify veterans impacted by food insecurity, assess for associated clinical and/or social risk factors, and offer appropriate medical and nutrition interventions and resource referrals.

This interdisciplinary team-based model is essential given the range of potential drivers underlying veteran experiences of food insecurity and subsequent health outcomes. It is critically important for clinicians to review the medication list with veterans screening positive for food insecurity to assess for risk of hypoglycemia and/or cost-related nonadherence, make any necessary adjustments to therapeutic regimens, and assess for additional risk factors associated with food insecurity. Examples of tailored nutrition counseling that clinical dietitians may provide include meal preparation strategies for veterans who only have access to a microwave or hotplate, or recommendations for how veterans on medically restricted diets can best navigate food selection at soup kitchens or food pantries. Resource referrals provided by social workers or other care team members may include both emergency food resources to address immediate shortages (eg, food pantries, soup kitchens, or vouchers for free lunch) as well as resources focused on improving longer term food security (eg, federal food assistance programs or home delivered meal programs). Importantly, although providing a list of food resources may be helpful for some patients, such lists are often insufficient.^62,63 Many patients require active assistance with program enrollment either onsite the day of their clinic visit or through connection with a partnering community-based organization that can, in turn, identify appropriate resources and facilitate program enrollment.^63,64 Planned follow-up is also crucial to determine whether referrals are successful and to assess for ongoing need. Proposed roles for interdisciplinary care team members in addressing a positive food insecurity screen are outlined in Table 1.

VHA-Community Partnerships

In addition to services offered within VA, public and private sector partnerships can greatly enhance the range of resources available to food insecure veterans. Several VA facilities have developed formal community partnerships, such as the Veterans Pantry Pilot (VPP) program, a national partnership between Feeding America food banks and VA medical centers to establish onsite or mobile food pantries. There are currently 17 active Feeding America VPP sites, with a number of additional sites under development. Several of the VPP sites also include other “wraparound services,” such as SNAP application assistance.^65,66

State Veterans Affairs offices⁶⁷ and Veterans Service Organizations (VSOs)⁶⁸ also can serve as valuable partners for connecting veterans with needed resources. VSOs offer a range of services, including assistancewith benefit claims, employment and housing assistance, emergency food assistance, and transportation to medical appointments. Some VSOs also have established local affiliations with Meals on Wheels focused on veteran outreach and providing hot meals for low-income, homebound, and disabled veterans.

Additional Resources

Although resources vary by regional setting, several key governmental and community-based food assistance programs are summarized in Table 2. Local community partners and online/phone-based directories, such as United Way’s 2-1-1 can help identify additional local resources. For older adults and individuals with disabilities, local Aging and Disability Resources Centers can provide information and assistance connecting to needed resources.⁶⁹ Finally, there are a number of online resources available for clinicians interested in learning more about the impact of food insecurity on health and tools to use in the clinical setting (Table 3).

Conclusion

The VA has recognized food insecurity as a critical concern for the well-being of our nation’s veterans. Use of the EHR clinical reminder represents a crucial first step toward increasing provider awareness about veteran food insecurity and improving clinical efforts to address food insecurity once identified. Through the reminder, health care teams can connect veterans to needed resources and create both the individual and population-level data necessary to inform VHA and community efforts to address veteran food insecurity. Clinical reminder data are currently being used for local quality improvement efforts and have established the need nationally for formalized partnerships between VHA Social Work Services and Nutrition and Food Services to connect veterans with food and provide them with strategies to best use available food resources.

Moving forward, the Ensuring Veteran Food Security Workgroup continues to work with agencies and organizations across the country to improve food insecure veterans’ access to needed services. In addition to existing VA partnerships with Feeding America for the VPP, memorandums of understanding are currently underway to formalize partnerships with both the Food Research and Action Center (FRAC) and MAZON. Additional research is needed both to formally validate the current food insecurity clinical reminder screening question and to identify best practices and potential models for how to most effectively use VHA-community partnerships to address the unique needs of the veteran population.

Ensuring the food security of our nation’s veterans is essential to VA’s commitment to providing integrated, veteran-centered, whole person care. Toward that goal, VA health care teams are urged to use the clinical reminder and help connect food insecure veterans with relevant resources both within and outside of the VA health care system.

Cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) is a key co-stimulatory receptor expressed on activated T cells that negatively regulates T-cell activation.^1-3 It exerts its effects in part by the prevention of IL-2 transcription and inhibition of cell-cycle progression.⁴ Cytotoxic T-lymphocyte–associated antigen 4 also is expressed by a subset of CD25⁺CD4⁺ regulatory T cells (Tregs), where it plays a role in immune tolerance.⁵ Blockade has demonstrated antitumor activity as well as immune activation, and CTLA-4 dysregulation has been implicated in autoimmune diseases such as alopecia areata (AA).⁶

Ipilimumab is a fully humanized monoclonal antibody against CTLA-4 and one of a growing class of immune checkpoint inhibitor therapies for metastatic melanoma. Phase 2 and 3 clinical trials have shown an improved survival effect of ipilimumab in patients with advanced melanoma,^7-10 with 3-year survival rates ranging from 20.8% to 46.5%.^10,11 The US Food and Drug Administration approved ipilimumab in 2011 for treatment of unresectable or metastatic melanoma.¹² The most common toxicities of ipilimumab are immune-related adverse effects (irAEs), which represent loss of tolerance to self-antigens.¹³ Immune-related adverse effects occur in 64.2% of patients,¹⁴ with severe or life-threatening irAEs in 17.8% of patients.¹⁴ Rates of irAEs appear dose dependent but consistent across increased doses.¹⁵ Cutaneous irAEs occur in more than 47% of patients¹⁶ and commonly manifest as pruritus with or without a diffuse morbilliform rash,^10,17 though less common skin reactions, including vitiligo, vasculitis, and Stevens-Johnson syndrome/toxic epidermal necrolysis, have been documented.^9,18

Generalized AA and its more widespread variant, alopecia universalis, have been reported as adverse effects of ipilimumab monotherapy in 2 prior cases in the English-language literature (Table).^17,19 Alopecia areata also has been attributed to combination immune checkpoint inhibitor therapy.^20,21 We report a case of AA attributable to ipilimumab monotherapy that was localized exclusively to the scalp and remote in onset following treatment.

Case Report

An 88-year-old man with pT3bpN3 nodular melanoma of the back demonstrated multiple lung metastases by positron emission tomography–computed tomography. Lactate dehydrogenase was within reference range, and his Eastern Cooperative Oncology Group performance status was 0 (fully active). One month later, he was started on ipilimumab 3 mg/kg intravenous infusion every 3 weeks for a total of 4 doses. At approximately week 6, his course was complicated by mild fatigue, a faintly erythematous morbilliform rash, and mild pruritus, with laboratory evidence of subclinical hyperthyroidism. Follow-up positron emission tomography–computed tomography at the conclusion of treatment demonstrated complete regression of previously noted hypermetabolic foci. His symptoms and subclinical hyperthyroidism resolved several months later.

Seventeen months after completion of ipilimumab therapy (at age 90 years), the patient’s barber noted new-onset hair loss on the right occipital scalp. Physical examination demonstrated a well-circumscribed patch of nonscarring alopecia (approximately 6 cm) that was clinically consistent with AA (Figure). There were no associated symptoms or other involved areas of hair loss. He denied any personal or family history of AA. The patient’s melanoma has remained in remission to date.

Comment

This case is unique in that AA was localized to a single circumscribed patch on the scalp and occurred nearly 1.5 years after treatment with ipilimumab, which may indicate a robust blockade of CTLA-4 given the remote development of autoimmunity in the setting of persistent remission of melanoma. Although the appearance of AA may be coincidental, onset at 90 years of age would be unusual. The mean age of onset of AA has been reported between 25.2 and 36.3 years,^22,23 and its incidence in men older than 60 years is only 6.4 per 100,000 person-years.²⁴

Although AA is a rare irAE of CTLA-4 blockade, the disease has been increasingly linked to CTLA-4 dysregulation in both animal models and humans.^6,25,26 A genome-wide association study of 1054 patients with AA and 3278 controls implicated several genes controlling activation and proliferation of Tregs, including CTLA-4.²⁷ More specifically, single-nucleotide polymorphisms of the CTLA-4 gene were found to be associated with AA in a study of 1196 unrelated patients and 1280 controls,²⁸ and Megiorni et al²⁹ identified a single-nucleotide polymorphism of CTLA-4, CT60, as a contributory genetic determinant of AA in Italian patients.

Given the role of CTLA-4 dysregulation in the pathogenesis of AA, the very low rates of AA in ipilimumab are somewhat surprising, which may represent a reporting bias. Alternatively, there may be sufficient Treg activity to prevent high rates of AA at a lower ipilimumab dose of 3 mg/kg but insufficient activity to prevent development of other irAEs. With US Food and Drug Administration approval of ipilimumab at a higher dose of 10 mg/kg for use as adjuvant therapy for stage III melanomas,¹² less common cutaneous irAEs such as AA may be seen with increased frequency. Clinicians planning ipilimumab therapy should discuss this side effect and other potential irAEs with their patients before initiation of treatment.

Cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) is a key co-stimulatory receptor expressed on activated T cells that negatively regulates T-cell activation.^1-3 It exerts its effects in part by the prevention of IL-2 transcription and inhibition of cell-cycle progression.⁴ Cytotoxic T-lymphocyte–associated antigen 4 also is expressed by a subset of CD25⁺CD4⁺ regulatory T cells (Tregs), where it plays a role in immune tolerance.⁵ Blockade has demonstrated antitumor activity as well as immune activation, and CTLA-4 dysregulation has been implicated in autoimmune diseases such as alopecia areata (AA).⁶

Ipilimumab is a fully humanized monoclonal antibody against CTLA-4 and one of a growing class of immune checkpoint inhibitor therapies for metastatic melanoma. Phase 2 and 3 clinical trials have shown an improved survival effect of ipilimumab in patients with advanced melanoma,^7-10 with 3-year survival rates ranging from 20.8% to 46.5%.^10,11 The US Food and Drug Administration approved ipilimumab in 2011 for treatment of unresectable or metastatic melanoma.¹² The most common toxicities of ipilimumab are immune-related adverse effects (irAEs), which represent loss of tolerance to self-antigens.¹³ Immune-related adverse effects occur in 64.2% of patients,¹⁴ with severe or life-threatening irAEs in 17.8% of patients.¹⁴ Rates of irAEs appear dose dependent but consistent across increased doses.¹⁵ Cutaneous irAEs occur in more than 47% of patients¹⁶ and commonly manifest as pruritus with or without a diffuse morbilliform rash,^10,17 though less common skin reactions, including vitiligo, vasculitis, and Stevens-Johnson syndrome/toxic epidermal necrolysis, have been documented.^9,18

Generalized AA and its more widespread variant, alopecia universalis, have been reported as adverse effects of ipilimumab monotherapy in 2 prior cases in the English-language literature (Table).^17,19 Alopecia areata also has been attributed to combination immune checkpoint inhibitor therapy.^20,21 We report a case of AA attributable to ipilimumab monotherapy that was localized exclusively to the scalp and remote in onset following treatment.

Case Report

An 88-year-old man with pT3bpN3 nodular melanoma of the back demonstrated multiple lung metastases by positron emission tomography–computed tomography. Lactate dehydrogenase was within reference range, and his Eastern Cooperative Oncology Group performance status was 0 (fully active). One month later, he was started on ipilimumab 3 mg/kg intravenous infusion every 3 weeks for a total of 4 doses. At approximately week 6, his course was complicated by mild fatigue, a faintly erythematous morbilliform rash, and mild pruritus, with laboratory evidence of subclinical hyperthyroidism. Follow-up positron emission tomography–computed tomography at the conclusion of treatment demonstrated complete regression of previously noted hypermetabolic foci. His symptoms and subclinical hyperthyroidism resolved several months later.

Seventeen months after completion of ipilimumab therapy (at age 90 years), the patient’s barber noted new-onset hair loss on the right occipital scalp. Physical examination demonstrated a well-circumscribed patch of nonscarring alopecia (approximately 6 cm) that was clinically consistent with AA (Figure). There were no associated symptoms or other involved areas of hair loss. He denied any personal or family history of AA. The patient’s melanoma has remained in remission to date.

Comment

This case is unique in that AA was localized to a single circumscribed patch on the scalp and occurred nearly 1.5 years after treatment with ipilimumab, which may indicate a robust blockade of CTLA-4 given the remote development of autoimmunity in the setting of persistent remission of melanoma. Although the appearance of AA may be coincidental, onset at 90 years of age would be unusual. The mean age of onset of AA has been reported between 25.2 and 36.3 years,^22,23 and its incidence in men older than 60 years is only 6.4 per 100,000 person-years.²⁴

Although AA is a rare irAE of CTLA-4 blockade, the disease has been increasingly linked to CTLA-4 dysregulation in both animal models and humans.^6,25,26 A genome-wide association study of 1054 patients with AA and 3278 controls implicated several genes controlling activation and proliferation of Tregs, including CTLA-4.²⁷ More specifically, single-nucleotide polymorphisms of the CTLA-4 gene were found to be associated with AA in a study of 1196 unrelated patients and 1280 controls,²⁸ and Megiorni et al²⁹ identified a single-nucleotide polymorphism of CTLA-4, CT60, as a contributory genetic determinant of AA in Italian patients.

Given the role of CTLA-4 dysregulation in the pathogenesis of AA, the very low rates of AA in ipilimumab are somewhat surprising, which may represent a reporting bias. Alternatively, there may be sufficient Treg activity to prevent high rates of AA at a lower ipilimumab dose of 3 mg/kg but insufficient activity to prevent development of other irAEs. With US Food and Drug Administration approval of ipilimumab at a higher dose of 10 mg/kg for use as adjuvant therapy for stage III melanomas,¹² less common cutaneous irAEs such as AA may be seen with increased frequency. Clinicians planning ipilimumab therapy should discuss this side effect and other potential irAEs with their patients before initiation of treatment.

Cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) is a key co-stimulatory receptor expressed on activated T cells that negatively regulates T-cell activation.^1-3 It exerts its effects in part by the prevention of IL-2 transcription and inhibition of cell-cycle progression.⁴ Cytotoxic T-lymphocyte–associated antigen 4 also is expressed by a subset of CD25⁺CD4⁺ regulatory T cells (Tregs), where it plays a role in immune tolerance.⁵ Blockade has demonstrated antitumor activity as well as immune activation, and CTLA-4 dysregulation has been implicated in autoimmune diseases such as alopecia areata (AA).⁶

Ipilimumab is a fully humanized monoclonal antibody against CTLA-4 and one of a growing class of immune checkpoint inhibitor therapies for metastatic melanoma. Phase 2 and 3 clinical trials have shown an improved survival effect of ipilimumab in patients with advanced melanoma,^7-10 with 3-year survival rates ranging from 20.8% to 46.5%.^10,11 The US Food and Drug Administration approved ipilimumab in 2011 for treatment of unresectable or metastatic melanoma.¹² The most common toxicities of ipilimumab are immune-related adverse effects (irAEs), which represent loss of tolerance to self-antigens.¹³ Immune-related adverse effects occur in 64.2% of patients,¹⁴ with severe or life-threatening irAEs in 17.8% of patients.¹⁴ Rates of irAEs appear dose dependent but consistent across increased doses.¹⁵ Cutaneous irAEs occur in more than 47% of patients¹⁶ and commonly manifest as pruritus with or without a diffuse morbilliform rash,^10,17 though less common skin reactions, including vitiligo, vasculitis, and Stevens-Johnson syndrome/toxic epidermal necrolysis, have been documented.^9,18

Generalized AA and its more widespread variant, alopecia universalis, have been reported as adverse effects of ipilimumab monotherapy in 2 prior cases in the English-language literature (Table).^17,19 Alopecia areata also has been attributed to combination immune checkpoint inhibitor therapy.^20,21 We report a case of AA attributable to ipilimumab monotherapy that was localized exclusively to the scalp and remote in onset following treatment.

Case Report

An 88-year-old man with pT3bpN3 nodular melanoma of the back demonstrated multiple lung metastases by positron emission tomography–computed tomography. Lactate dehydrogenase was within reference range, and his Eastern Cooperative Oncology Group performance status was 0 (fully active). One month later, he was started on ipilimumab 3 mg/kg intravenous infusion every 3 weeks for a total of 4 doses. At approximately week 6, his course was complicated by mild fatigue, a faintly erythematous morbilliform rash, and mild pruritus, with laboratory evidence of subclinical hyperthyroidism. Follow-up positron emission tomography–computed tomography at the conclusion of treatment demonstrated complete regression of previously noted hypermetabolic foci. His symptoms and subclinical hyperthyroidism resolved several months later.

Seventeen months after completion of ipilimumab therapy (at age 90 years), the patient’s barber noted new-onset hair loss on the right occipital scalp. Physical examination demonstrated a well-circumscribed patch of nonscarring alopecia (approximately 6 cm) that was clinically consistent with AA (Figure). There were no associated symptoms or other involved areas of hair loss. He denied any personal or family history of AA. The patient’s melanoma has remained in remission to date.

Comment

This case is unique in that AA was localized to a single circumscribed patch on the scalp and occurred nearly 1.5 years after treatment with ipilimumab, which may indicate a robust blockade of CTLA-4 given the remote development of autoimmunity in the setting of persistent remission of melanoma. Although the appearance of AA may be coincidental, onset at 90 years of age would be unusual. The mean age of onset of AA has been reported between 25.2 and 36.3 years,^22,23 and its incidence in men older than 60 years is only 6.4 per 100,000 person-years.²⁴

Although AA is a rare irAE of CTLA-4 blockade, the disease has been increasingly linked to CTLA-4 dysregulation in both animal models and humans.^6,25,26 A genome-wide association study of 1054 patients with AA and 3278 controls implicated several genes controlling activation and proliferation of Tregs, including CTLA-4.²⁷ More specifically, single-nucleotide polymorphisms of the CTLA-4 gene were found to be associated with AA in a study of 1196 unrelated patients and 1280 controls,²⁸ and Megiorni et al²⁹ identified a single-nucleotide polymorphism of CTLA-4, CT60, as a contributory genetic determinant of AA in Italian patients.

Given the role of CTLA-4 dysregulation in the pathogenesis of AA, the very low rates of AA in ipilimumab are somewhat surprising, which may represent a reporting bias. Alternatively, there may be sufficient Treg activity to prevent high rates of AA at a lower ipilimumab dose of 3 mg/kg but insufficient activity to prevent development of other irAEs. With US Food and Drug Administration approval of ipilimumab at a higher dose of 10 mg/kg for use as adjuvant therapy for stage III melanomas,¹² less common cutaneous irAEs such as AA may be seen with increased frequency. Clinicians planning ipilimumab therapy should discuss this side effect and other potential irAEs with their patients before initiation of treatment.

The certainty that federal health care will be different, and the equal uncertainty about when and how the systems will evolve, were major topics at the recent AMSUS annual meeting. The Veterans Health Administration (VHA) and Military Health System (MHS) are in the midst of major transformations, although they are at very different points in the process and the final outcomes are yet unknown. This editorial, written at the end of 2019, will review some of the highlights of a discussion that is sure to continue in 2020 and beyond.

Almost everyone in the VA and many of the public can pinpoint the exact place (and time) the VHA’s upheaval began: Phoenix, Arizona, in 2014. “The attack on our system,” as VHA Executive in Charge Richard A. Stone, MD, described it at AMSUS, happened because “we were just too slow a bureaucracy,” he explained.¹ “We can debate how many veterans died while waiting for care, but the answer is that 1 was too many and it had to be fixed. We had to become a more agile organization.”

The US Department of Veterans Affairs (VA) response to the media firestorm and congressional outrage was uncharacteristically swift and sweeping. Both the VA Secretary and Deputy Under Secretary of Health were removed, as were many others in leadership at Phoenix and elsewhere. The VA faced an existential crisis as many loud voices called for dismantling the entire system in the wake of its perceived inability or unwillingness to care for those it was legally mandated to serve.² The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 and its successor the VA Mission Act of 2018 dramatically expanded veterans’ access to covered health care from non-VA health care providers (HCPs).

Debate continues in the veteran community and the wider society about whether this expansion constitutes an abandonment of a health care system dedicated to veterans and their unique health problems or a commitment to deliver the most efficient and high-quality care to veterans that can be obtained.^3-5 Many see this as a crossroads for the VA. Still, even if the VA will continue to exist, the question remains: in what form?

The increased use of private sector HCPs has wrought significant and long-lasting modifications to the traditional VA organization. In fiscal year (FY) 2017, the VA paid for care that non-VA HCPs provided for 24% of patients.⁶ Veterans with higher service-connected disability ratings and aged > 65 years were more likely to rely on the VA for care than were less disabled and younger patients.⁶ The Mission Act is expected to increase the VA expenditures by nearly $19 billion between FY 2019 and FY 2023, with the bulk of the patients still going to the VHA for their care.⁶ Stakeholders from unions to politicians are concerned that every dollar spent on community care is one less they can spend in VA institutions. It is unclear to what degree this concern will be actualized, as smaller hospitals and those in rural areas have always had contact with the private sector to obtain the specialty care veterans needed that the VA could not provide.

Compounding these trends is the VA’s ongoing staffing challenges. To meet the demand and eliminate wait times between September 2014 and September 2018, the VHA grew its workforce by > 40,000 individuals, a 13% growth rate. In FY 2019 alone, the VHA hired 28,000 new employees. And yet despite the rapid growth, a lower than average turnover rate, and relatively high employee satisfaction measures (at least when compared with those of other federal employees), the VHA still has 43,000 vacancies.^7,8

Which brings us to the very different set of challenges facing the Defense Health Agency (DHA). In an era of ballooning military budgets the DHA is being asked to “transform the MHS into an integrated readiness and health system, eliminate redundancies, and create a common high-quality experience for our beneficiaries.”⁹ The seeds of change were tucked into the National Defense Authorization Act (NDAA) of 2017, and their ramifications are only now becoming apparent. Among the most consequential of these changes are transfer of the management of hundreds of MHS hospitals and clinics from the medical services of the Army, Navy, and Air Force to the DHA.

“If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs explained at AMSUS.¹⁰ In October 2019, DoD transitioned the first group of facilities to the DHA, and the remainder will change management by the end of 2022. In the next step of the process, facilities will be combined—along with TRICARE providers—in 21 geographically based “markets” to streamline management and avoid “redundancies.” 

Lost in the bland language, though, is the scale of the contemplated changes. Although the exact shape of the changes have not been finalized, up to 18,000 MHS health care providers—civilian or uniformed—may be eliminated as DHA relies more heavily on TRICARE providers.¹¹ Not even the future of the Uniformed Service University for the Health Sciences and its leadership training and health care research are guaranteed.¹² The ominous possibility that the nation could lose its only military medical school has raised alarm among medical educators. They fear that the country may sacrifice its ability to train physicians with the highly skilled specialities needed on the battlefield and the familiarity with military culture that enables doctors in uniform to relate to the problems of active-duty families and retired service members.¹²VHA and MHS colleagues are undergoing a similar organizational transition with all the trepidation and expectation that accompanies the turning of an enormous ship in stormy seas. In the midst of these major institutional transformations, VHA and MHS need to band together if the unique specialty of military and VA medicine is to survive. Unless these unprecedented changes can establish a new spirit of solidarity to 2 often separate partners in one mission to care for those who serve, we may well be asking in the next few years, “Where have all the federal practitioners gone?”

The certainty that federal health care will be different, and the equal uncertainty about when and how the systems will evolve, were major topics at the recent AMSUS annual meeting. The Veterans Health Administration (VHA) and Military Health System (MHS) are in the midst of major transformations, although they are at very different points in the process and the final outcomes are yet unknown. This editorial, written at the end of 2019, will review some of the highlights of a discussion that is sure to continue in 2020 and beyond.

Almost everyone in the VA and many of the public can pinpoint the exact place (and time) the VHA’s upheaval began: Phoenix, Arizona, in 2014. “The attack on our system,” as VHA Executive in Charge Richard A. Stone, MD, described it at AMSUS, happened because “we were just too slow a bureaucracy,” he explained.¹ “We can debate how many veterans died while waiting for care, but the answer is that 1 was too many and it had to be fixed. We had to become a more agile organization.”

The US Department of Veterans Affairs (VA) response to the media firestorm and congressional outrage was uncharacteristically swift and sweeping. Both the VA Secretary and Deputy Under Secretary of Health were removed, as were many others in leadership at Phoenix and elsewhere. The VA faced an existential crisis as many loud voices called for dismantling the entire system in the wake of its perceived inability or unwillingness to care for those it was legally mandated to serve.² The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 and its successor the VA Mission Act of 2018 dramatically expanded veterans’ access to covered health care from non-VA health care providers (HCPs).

Debate continues in the veteran community and the wider society about whether this expansion constitutes an abandonment of a health care system dedicated to veterans and their unique health problems or a commitment to deliver the most efficient and high-quality care to veterans that can be obtained.^3-5 Many see this as a crossroads for the VA. Still, even if the VA will continue to exist, the question remains: in what form?

The increased use of private sector HCPs has wrought significant and long-lasting modifications to the traditional VA organization. In fiscal year (FY) 2017, the VA paid for care that non-VA HCPs provided for 24% of patients.⁶ Veterans with higher service-connected disability ratings and aged > 65 years were more likely to rely on the VA for care than were less disabled and younger patients.⁶ The Mission Act is expected to increase the VA expenditures by nearly $19 billion between FY 2019 and FY 2023, with the bulk of the patients still going to the VHA for their care.⁶ Stakeholders from unions to politicians are concerned that every dollar spent on community care is one less they can spend in VA institutions. It is unclear to what degree this concern will be actualized, as smaller hospitals and those in rural areas have always had contact with the private sector to obtain the specialty care veterans needed that the VA could not provide.

Compounding these trends is the VA’s ongoing staffing challenges. To meet the demand and eliminate wait times between September 2014 and September 2018, the VHA grew its workforce by > 40,000 individuals, a 13% growth rate. In FY 2019 alone, the VHA hired 28,000 new employees. And yet despite the rapid growth, a lower than average turnover rate, and relatively high employee satisfaction measures (at least when compared with those of other federal employees), the VHA still has 43,000 vacancies.^7,8

Which brings us to the very different set of challenges facing the Defense Health Agency (DHA). In an era of ballooning military budgets the DHA is being asked to “transform the MHS into an integrated readiness and health system, eliminate redundancies, and create a common high-quality experience for our beneficiaries.”⁹ The seeds of change were tucked into the National Defense Authorization Act (NDAA) of 2017, and their ramifications are only now becoming apparent. Among the most consequential of these changes are transfer of the management of hundreds of MHS hospitals and clinics from the medical services of the Army, Navy, and Air Force to the DHA.

“If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs explained at AMSUS.¹⁰ In October 2019, DoD transitioned the first group of facilities to the DHA, and the remainder will change management by the end of 2022. In the next step of the process, facilities will be combined—along with TRICARE providers—in 21 geographically based “markets” to streamline management and avoid “redundancies.” 

Lost in the bland language, though, is the scale of the contemplated changes. Although the exact shape of the changes have not been finalized, up to 18,000 MHS health care providers—civilian or uniformed—may be eliminated as DHA relies more heavily on TRICARE providers.¹¹ Not even the future of the Uniformed Service University for the Health Sciences and its leadership training and health care research are guaranteed.¹² The ominous possibility that the nation could lose its only military medical school has raised alarm among medical educators. They fear that the country may sacrifice its ability to train physicians with the highly skilled specialities needed on the battlefield and the familiarity with military culture that enables doctors in uniform to relate to the problems of active-duty families and retired service members.¹²VHA and MHS colleagues are undergoing a similar organizational transition with all the trepidation and expectation that accompanies the turning of an enormous ship in stormy seas. In the midst of these major institutional transformations, VHA and MHS need to band together if the unique specialty of military and VA medicine is to survive. Unless these unprecedented changes can establish a new spirit of solidarity to 2 often separate partners in one mission to care for those who serve, we may well be asking in the next few years, “Where have all the federal practitioners gone?”

The certainty that federal health care will be different, and the equal uncertainty about when and how the systems will evolve, were major topics at the recent AMSUS annual meeting. The Veterans Health Administration (VHA) and Military Health System (MHS) are in the midst of major transformations, although they are at very different points in the process and the final outcomes are yet unknown. This editorial, written at the end of 2019, will review some of the highlights of a discussion that is sure to continue in 2020 and beyond.

Almost everyone in the VA and many of the public can pinpoint the exact place (and time) the VHA’s upheaval began: Phoenix, Arizona, in 2014. “The attack on our system,” as VHA Executive in Charge Richard A. Stone, MD, described it at AMSUS, happened because “we were just too slow a bureaucracy,” he explained.¹ “We can debate how many veterans died while waiting for care, but the answer is that 1 was too many and it had to be fixed. We had to become a more agile organization.”

The US Department of Veterans Affairs (VA) response to the media firestorm and congressional outrage was uncharacteristically swift and sweeping. Both the VA Secretary and Deputy Under Secretary of Health were removed, as were many others in leadership at Phoenix and elsewhere. The VA faced an existential crisis as many loud voices called for dismantling the entire system in the wake of its perceived inability or unwillingness to care for those it was legally mandated to serve.² The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 and its successor the VA Mission Act of 2018 dramatically expanded veterans’ access to covered health care from non-VA health care providers (HCPs).

Debate continues in the veteran community and the wider society about whether this expansion constitutes an abandonment of a health care system dedicated to veterans and their unique health problems or a commitment to deliver the most efficient and high-quality care to veterans that can be obtained.^3-5 Many see this as a crossroads for the VA. Still, even if the VA will continue to exist, the question remains: in what form?

The increased use of private sector HCPs has wrought significant and long-lasting modifications to the traditional VA organization. In fiscal year (FY) 2017, the VA paid for care that non-VA HCPs provided for 24% of patients.⁶ Veterans with higher service-connected disability ratings and aged > 65 years were more likely to rely on the VA for care than were less disabled and younger patients.⁶ The Mission Act is expected to increase the VA expenditures by nearly $19 billion between FY 2019 and FY 2023, with the bulk of the patients still going to the VHA for their care.⁶ Stakeholders from unions to politicians are concerned that every dollar spent on community care is one less they can spend in VA institutions. It is unclear to what degree this concern will be actualized, as smaller hospitals and those in rural areas have always had contact with the private sector to obtain the specialty care veterans needed that the VA could not provide.

Compounding these trends is the VA’s ongoing staffing challenges. To meet the demand and eliminate wait times between September 2014 and September 2018, the VHA grew its workforce by > 40,000 individuals, a 13% growth rate. In FY 2019 alone, the VHA hired 28,000 new employees. And yet despite the rapid growth, a lower than average turnover rate, and relatively high employee satisfaction measures (at least when compared with those of other federal employees), the VHA still has 43,000 vacancies.^7,8

Which brings us to the very different set of challenges facing the Defense Health Agency (DHA). In an era of ballooning military budgets the DHA is being asked to “transform the MHS into an integrated readiness and health system, eliminate redundancies, and create a common high-quality experience for our beneficiaries.”⁹ The seeds of change were tucked into the National Defense Authorization Act (NDAA) of 2017, and their ramifications are only now becoming apparent. Among the most consequential of these changes are transfer of the management of hundreds of MHS hospitals and clinics from the medical services of the Army, Navy, and Air Force to the DHA.

“If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs explained at AMSUS.¹⁰ In October 2019, DoD transitioned the first group of facilities to the DHA, and the remainder will change management by the end of 2022. In the next step of the process, facilities will be combined—along with TRICARE providers—in 21 geographically based “markets” to streamline management and avoid “redundancies.” 

Lost in the bland language, though, is the scale of the contemplated changes. Although the exact shape of the changes have not been finalized, up to 18,000 MHS health care providers—civilian or uniformed—may be eliminated as DHA relies more heavily on TRICARE providers.¹¹ Not even the future of the Uniformed Service University for the Health Sciences and its leadership training and health care research are guaranteed.¹² The ominous possibility that the nation could lose its only military medical school has raised alarm among medical educators. They fear that the country may sacrifice its ability to train physicians with the highly skilled specialities needed on the battlefield and the familiarity with military culture that enables doctors in uniform to relate to the problems of active-duty families and retired service members.¹²VHA and MHS colleagues are undergoing a similar organizational transition with all the trepidation and expectation that accompanies the turning of an enormous ship in stormy seas. In the midst of these major institutional transformations, VHA and MHS need to band together if the unique specialty of military and VA medicine is to survive. Unless these unprecedented changes can establish a new spirit of solidarity to 2 often separate partners in one mission to care for those who serve, we may well be asking in the next few years, “Where have all the federal practitioners gone?”

Editor’s Note: I am very excited to introduce a section to The New Gastroenterologist that will address topics in clinical medical ethics we frequently face as gastroenterologists. There are several inherent ethical issues in gastroenterology that are not often explicitly discussed, such as periprocedural code status, informed consent, transplantation, performance of endoscopy in the critically ill, and nutrition support in the setting of end of life care. Often the most difficult decisions we make as clinicians are fraught with ethical implications which can be daunting and difficult to navigate. The goal of this section is to address these issues in a case-based format to offer some guidance to young gastroenterologists grappling with similar scenarios.

This month’s issue features the inaugural piece for this series, written by Dr. Lauren Feld (University of Washington), which discusses a clinical scenario in which a patient with a preexisting do-not-resuscitate (DNR) order is about to undergo endoscopy. The article provides a systematic approach to periprocedural code status and highlights existing guidelines that are generally not well known among gastroenterologists.
 

Vijaya L. Rao, MD
Editor in Chief

An 89-year old female with history of heart failure with reduced ejection fraction, chronic obstructive pulmonary disease, and dementia is admitted to the intensive care unit (ICU) with melena and acute post-hemorrhagic anemia. The family member designated as the patient’s power of attorney (POA) agrees that her code status upon admission will be do-not-resuscitate and do-not-intubate (DNR/DNI) without plan for invasive procedures. However, she has continued overt bleeding with concomitant hemodynamic instability. The POA and ICU team are now asking for urgent endoscopic evaluation, but do not agree to temporary code reversal for the duration of the procedure.

This vignette highlights an important distinction between a patient’s goals of care and the code status. While these two terms are often erroneously used interchangeably, “code status” refers to a patient’s wishes in the event of cardiopulmonary arrest, while “goals of care” refers to a more comprehensive understanding of what care fits within a patient’s values. Patients or their families may still desire interventions such as procedures, but not wish to have a resuscitation attempt in the event of cardiopulmonary arrest. This leads to the commonly encountered clinical scenario in which a patient planning to undergo endoscopy has an active DNR order.

Frequently, DNR orders are temporarily rescinded prior to invasive procedures. There are several reasons this occurs. First, patients or decision makers may decide that the improved rates of survival in intraprocedural arrests changes their risk-benefit assessment about resuscitation procedures. Secondly, proceduralists may feel an ethical duty to resuscitate a patient if the cause of the arrest is considered iatrogenic and potentially reversible. In addition, proceduralists may worry about legal or professional risk if a patient suffers cardiopulmonary arrest during a procedure and an attempt at resuscitation does not occur.

While this is a frequently encountered clinical scenario, there is wide variation in clinical practice. This variation led to the creation of guidelines set forth by the American Society of Anesthesiologists in 1993 and subsequently adopted by the American College of Surgeons. These guidelines recommend a discussion between the physician and the patient prior to the procedure, utilizing shared decision-making around three options: 1) a full attempt at resuscitation; 2) a limited attempt at resuscitation defined with regard to specific procedures; and 3) a limited attempt at resuscitation defined with regard to the patient’s goals and values.

However, these guidelines are both not well known and frequently not applied amongst clinicians and ancillary staff. Patients are frequently told that they must reverse their DNR order to full code prior to undergoing endoscopy. Dissemination of a systematic approach to a patient with a DNR order who requires endoscopy is important to ensure patients have autonomy over their medical decision-making, while also ensuring that health care professionals feel comfortable with their decisions.

• Physicians should avoid one-size-fits-all policies, such as the expectation that patients routinely return to full code for procedures.
• The patient and/or decision-makers should have a discussion regarding the risks during the procedure and potential reversibility of these risks.
• The patient should be presented with the option to either reverse to full code, refuse specific resuscitative measures such as defibrillation or intubation, or be allowed to explain his or her own views on goals of care and allow the procedural team to use their clinical judgment should an emergency arise.
• Physicians should be specific regarding the duration of the code status change. For example, in a patient who has reversed the code status to allow a full resuscitation attempt, the team and patient should discuss how long the patient will remain intubated after the procedure.
• This discussion should be documented carefully in the chart to assist with dissemination amongst the medical team.

This process will ensure that clear guidelines are defined such that everyone, including the patient’s potential decision makers, understand to what they are agreeing.

While physicians and care teams are primarily concerned with providing high-quality and individualized care to patients, it is true that concerns surrounding medicolegal risk are present. Careful informed consent and informed refusal conversations will reduce risk. Indeed, in a patient who has a DNR order, physicians are more likely to be at risk performing resuscitation efforts than withholding them. Communication between patients, families, and physicians remains the foundation for a trusting relationship and decreased litigation risk.

For this patient, engaging her POA in an honest and thorough discussion about her goals of care, as well as the risks of both performing and not performing the upper endoscopy are critical to her care. If her POA wishes to proceed with the procedure and have her remain DNR during the procedure, this should be documented and adhered to. Ultimately, the best outcome for this patient will occur with an individualized risk-benefit assessment and open, frequent communication among the care team and her POA.
 

Dr. Feld is a gastroenterology and hepatology fellow in the department of gastroenterology and hepatology, University of Washington, Seattle. She has no conflicts of interest.

Editor’s Note: I am very excited to introduce a section to The New Gastroenterologist that will address topics in clinical medical ethics we frequently face as gastroenterologists. There are several inherent ethical issues in gastroenterology that are not often explicitly discussed, such as periprocedural code status, informed consent, transplantation, performance of endoscopy in the critically ill, and nutrition support in the setting of end of life care. Often the most difficult decisions we make as clinicians are fraught with ethical implications which can be daunting and difficult to navigate. The goal of this section is to address these issues in a case-based format to offer some guidance to young gastroenterologists grappling with similar scenarios.

This month’s issue features the inaugural piece for this series, written by Dr. Lauren Feld (University of Washington), which discusses a clinical scenario in which a patient with a preexisting do-not-resuscitate (DNR) order is about to undergo endoscopy. The article provides a systematic approach to periprocedural code status and highlights existing guidelines that are generally not well known among gastroenterologists.
 

Vijaya L. Rao, MD
Editor in Chief

An 89-year old female with history of heart failure with reduced ejection fraction, chronic obstructive pulmonary disease, and dementia is admitted to the intensive care unit (ICU) with melena and acute post-hemorrhagic anemia. The family member designated as the patient’s power of attorney (POA) agrees that her code status upon admission will be do-not-resuscitate and do-not-intubate (DNR/DNI) without plan for invasive procedures. However, she has continued overt bleeding with concomitant hemodynamic instability. The POA and ICU team are now asking for urgent endoscopic evaluation, but do not agree to temporary code reversal for the duration of the procedure.

This vignette highlights an important distinction between a patient’s goals of care and the code status. While these two terms are often erroneously used interchangeably, “code status” refers to a patient’s wishes in the event of cardiopulmonary arrest, while “goals of care” refers to a more comprehensive understanding of what care fits within a patient’s values. Patients or their families may still desire interventions such as procedures, but not wish to have a resuscitation attempt in the event of cardiopulmonary arrest. This leads to the commonly encountered clinical scenario in which a patient planning to undergo endoscopy has an active DNR order.

Frequently, DNR orders are temporarily rescinded prior to invasive procedures. There are several reasons this occurs. First, patients or decision makers may decide that the improved rates of survival in intraprocedural arrests changes their risk-benefit assessment about resuscitation procedures. Secondly, proceduralists may feel an ethical duty to resuscitate a patient if the cause of the arrest is considered iatrogenic and potentially reversible. In addition, proceduralists may worry about legal or professional risk if a patient suffers cardiopulmonary arrest during a procedure and an attempt at resuscitation does not occur.

While this is a frequently encountered clinical scenario, there is wide variation in clinical practice. This variation led to the creation of guidelines set forth by the American Society of Anesthesiologists in 1993 and subsequently adopted by the American College of Surgeons. These guidelines recommend a discussion between the physician and the patient prior to the procedure, utilizing shared decision-making around three options: 1) a full attempt at resuscitation; 2) a limited attempt at resuscitation defined with regard to specific procedures; and 3) a limited attempt at resuscitation defined with regard to the patient’s goals and values.

However, these guidelines are both not well known and frequently not applied amongst clinicians and ancillary staff. Patients are frequently told that they must reverse their DNR order to full code prior to undergoing endoscopy. Dissemination of a systematic approach to a patient with a DNR order who requires endoscopy is important to ensure patients have autonomy over their medical decision-making, while also ensuring that health care professionals feel comfortable with their decisions.

• Physicians should avoid one-size-fits-all policies, such as the expectation that patients routinely return to full code for procedures.
• The patient and/or decision-makers should have a discussion regarding the risks during the procedure and potential reversibility of these risks.
• The patient should be presented with the option to either reverse to full code, refuse specific resuscitative measures such as defibrillation or intubation, or be allowed to explain his or her own views on goals of care and allow the procedural team to use their clinical judgment should an emergency arise.
• Physicians should be specific regarding the duration of the code status change. For example, in a patient who has reversed the code status to allow a full resuscitation attempt, the team and patient should discuss how long the patient will remain intubated after the procedure.
• This discussion should be documented carefully in the chart to assist with dissemination amongst the medical team.

This process will ensure that clear guidelines are defined such that everyone, including the patient’s potential decision makers, understand to what they are agreeing.

While physicians and care teams are primarily concerned with providing high-quality and individualized care to patients, it is true that concerns surrounding medicolegal risk are present. Careful informed consent and informed refusal conversations will reduce risk. Indeed, in a patient who has a DNR order, physicians are more likely to be at risk performing resuscitation efforts than withholding them. Communication between patients, families, and physicians remains the foundation for a trusting relationship and decreased litigation risk.

For this patient, engaging her POA in an honest and thorough discussion about her goals of care, as well as the risks of both performing and not performing the upper endoscopy are critical to her care. If her POA wishes to proceed with the procedure and have her remain DNR during the procedure, this should be documented and adhered to. Ultimately, the best outcome for this patient will occur with an individualized risk-benefit assessment and open, frequent communication among the care team and her POA.
 

Dr. Feld is a gastroenterology and hepatology fellow in the department of gastroenterology and hepatology, University of Washington, Seattle. She has no conflicts of interest.

Editor’s Note: I am very excited to introduce a section to The New Gastroenterologist that will address topics in clinical medical ethics we frequently face as gastroenterologists. There are several inherent ethical issues in gastroenterology that are not often explicitly discussed, such as periprocedural code status, informed consent, transplantation, performance of endoscopy in the critically ill, and nutrition support in the setting of end of life care. Often the most difficult decisions we make as clinicians are fraught with ethical implications which can be daunting and difficult to navigate. The goal of this section is to address these issues in a case-based format to offer some guidance to young gastroenterologists grappling with similar scenarios.

This month’s issue features the inaugural piece for this series, written by Dr. Lauren Feld (University of Washington), which discusses a clinical scenario in which a patient with a preexisting do-not-resuscitate (DNR) order is about to undergo endoscopy. The article provides a systematic approach to periprocedural code status and highlights existing guidelines that are generally not well known among gastroenterologists.
 

Vijaya L. Rao, MD
Editor in Chief

An 89-year old female with history of heart failure with reduced ejection fraction, chronic obstructive pulmonary disease, and dementia is admitted to the intensive care unit (ICU) with melena and acute post-hemorrhagic anemia. The family member designated as the patient’s power of attorney (POA) agrees that her code status upon admission will be do-not-resuscitate and do-not-intubate (DNR/DNI) without plan for invasive procedures. However, she has continued overt bleeding with concomitant hemodynamic instability. The POA and ICU team are now asking for urgent endoscopic evaluation, but do not agree to temporary code reversal for the duration of the procedure.

This vignette highlights an important distinction between a patient’s goals of care and the code status. While these two terms are often erroneously used interchangeably, “code status” refers to a patient’s wishes in the event of cardiopulmonary arrest, while “goals of care” refers to a more comprehensive understanding of what care fits within a patient’s values. Patients or their families may still desire interventions such as procedures, but not wish to have a resuscitation attempt in the event of cardiopulmonary arrest. This leads to the commonly encountered clinical scenario in which a patient planning to undergo endoscopy has an active DNR order.

Frequently, DNR orders are temporarily rescinded prior to invasive procedures. There are several reasons this occurs. First, patients or decision makers may decide that the improved rates of survival in intraprocedural arrests changes their risk-benefit assessment about resuscitation procedures. Secondly, proceduralists may feel an ethical duty to resuscitate a patient if the cause of the arrest is considered iatrogenic and potentially reversible. In addition, proceduralists may worry about legal or professional risk if a patient suffers cardiopulmonary arrest during a procedure and an attempt at resuscitation does not occur.

While this is a frequently encountered clinical scenario, there is wide variation in clinical practice. This variation led to the creation of guidelines set forth by the American Society of Anesthesiologists in 1993 and subsequently adopted by the American College of Surgeons. These guidelines recommend a discussion between the physician and the patient prior to the procedure, utilizing shared decision-making around three options: 1) a full attempt at resuscitation; 2) a limited attempt at resuscitation defined with regard to specific procedures; and 3) a limited attempt at resuscitation defined with regard to the patient’s goals and values.

However, these guidelines are both not well known and frequently not applied amongst clinicians and ancillary staff. Patients are frequently told that they must reverse their DNR order to full code prior to undergoing endoscopy. Dissemination of a systematic approach to a patient with a DNR order who requires endoscopy is important to ensure patients have autonomy over their medical decision-making, while also ensuring that health care professionals feel comfortable with their decisions.

• Physicians should avoid one-size-fits-all policies, such as the expectation that patients routinely return to full code for procedures.
• The patient and/or decision-makers should have a discussion regarding the risks during the procedure and potential reversibility of these risks.
• The patient should be presented with the option to either reverse to full code, refuse specific resuscitative measures such as defibrillation or intubation, or be allowed to explain his or her own views on goals of care and allow the procedural team to use their clinical judgment should an emergency arise.
• Physicians should be specific regarding the duration of the code status change. For example, in a patient who has reversed the code status to allow a full resuscitation attempt, the team and patient should discuss how long the patient will remain intubated after the procedure.
• This discussion should be documented carefully in the chart to assist with dissemination amongst the medical team.

This process will ensure that clear guidelines are defined such that everyone, including the patient’s potential decision makers, understand to what they are agreeing.

While physicians and care teams are primarily concerned with providing high-quality and individualized care to patients, it is true that concerns surrounding medicolegal risk are present. Careful informed consent and informed refusal conversations will reduce risk. Indeed, in a patient who has a DNR order, physicians are more likely to be at risk performing resuscitation efforts than withholding them. Communication between patients, families, and physicians remains the foundation for a trusting relationship and decreased litigation risk.

For this patient, engaging her POA in an honest and thorough discussion about her goals of care, as well as the risks of both performing and not performing the upper endoscopy are critical to her care. If her POA wishes to proceed with the procedure and have her remain DNR during the procedure, this should be documented and adhered to. Ultimately, the best outcome for this patient will occur with an individualized risk-benefit assessment and open, frequent communication among the care team and her POA.
 

Dr. Feld is a gastroenterology and hepatology fellow in the department of gastroenterology and hepatology, University of Washington, Seattle. She has no conflicts of interest.

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.¹ On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.² In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.¹ Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.³ In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.² Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.⁴

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).⁵ Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.^5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”⁷ Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.⁶

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.⁸

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.^8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.^8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.⁸ In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.¹¹ In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.⁸

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.¹² The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).¹³

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.^14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.¹⁶ The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,^14,17 and minocycline foam is the first topical tetracycline.¹⁵

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.¹⁸ The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).¹⁹

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.²⁰ A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).²¹

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.^22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.²⁴ In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.^22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.²⁶ After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.²⁷ The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.²⁸

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.¹ On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.² In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.¹ Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.³ In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.² Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.⁴

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).⁵ Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.^5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”⁷ Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.⁶

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.⁸

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.^8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.^8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.⁸ In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.¹¹ In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.⁸

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.¹² The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).¹³

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.^14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.¹⁶ The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,^14,17 and minocycline foam is the first topical tetracycline.¹⁵

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.¹⁸ The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).¹⁹

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.²⁰ A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).²¹

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.^22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.²⁴ In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.^22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.²⁶ After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.²⁷ The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.²⁸

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.¹ On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.² In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.¹ Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.³ In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.² Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.⁴

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).⁵ Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.^5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”⁷ Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.⁶

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.⁸

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.^8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.^8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.⁸ In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.¹¹ In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.⁸

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.¹² The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).¹³

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.^14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.¹⁶ The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,^14,17 and minocycline foam is the first topical tetracycline.¹⁵

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.¹⁸ The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).¹⁹

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.²⁰ A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).²¹

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.^22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.²⁴ In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.^22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.²⁶ After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.²⁷ The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.²⁸

Antiepileptic drug (AED) exposure resulting from breastfeeding in infants is low, compared with exposure in mothers who took AEDs during pregnancy, according to a study published online ahead of print Dec. 30, 2019, in JAMA Neurology. The results may explain why previous research failed to find adverse neurodevelopmental effects of breastfeeding in infants whose mothers are undergoing AED treatment, said the authors.

“The results of this study add support to the general safety of breastfeeding by mothers with epilepsy who take AEDs,” wrote Angela K. Birnbaum, PhD, professor of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, and colleagues.
 

Investigators measured infants’ blood AED concentrations

To date, medical consensus about the safety of breastfeeding while the mother is taking AEDs has been elusive. Researchers have investigated breast milk concentrations of AEDs as surrogate markers of AED concentrations in children. Breast milk concentrations, however, do not account for differences in infant pharmacokinetic processes and thus could misrepresent AED exposure in children through breastfeeding.

Dr. Birnbaum and colleagues sought to measure blood concentrations of AEDs in mothers with epilepsy and the infants that they breastfed to achieve an objective measure of AED exposure through breastfeeding. They examined data collected from December 2012 to October 2016 in the prospective Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study. Eligible participants were pregnant women with epilepsy between the ages of 14 and 45 years whose pregnancies had progressed to fewer than 20 weeks’ gestational age and who had IQ scores greater than 70 points. Participants were followed up throughout pregnancy and for 9 months post partum. Children were enrolled at birth.

The investigators collected blood samples from mothers and infants who were breastfed at the same visit, which occurred at between 5 and 20 weeks after birth. The volume of ingested breast milk delivered through graduated feeding bottles each day and the total duration of all daily breastfeeding sessions were recorded. For infants, blood samples were collected from the plantar surface of the heel and stored as dried blood spots on filter paper. The study’s primary endpoint was the percentage of infant-to-mother concentration of AEDs. Concentrations of AEDs in infants at less than the lower limit of quantification were assessed as half of the lower limit.
 

Exposure in utero may be greater than exposure through breast milk

In all, the researchers enrolled 351 pregnant women with epilepsy into the study and collected data on 345 infants. Two hundred twenty-two (64.3%) of the infants were breastfed, and 146 (42.3%) had AED concentrations available. After excluding outliers and mothers with missing concentration data, Dr. Birnbaum and colleagues included 164 matching infant-mother concentration pairs in their analysis (i.e., of 135 mothers and 138 infants). Approximately 52% of the infants were female, and their median age at blood collection was 13 weeks. The mothers’ median age was 32 years. About 82% of mothers were receiving monotherapy. The investigators found no demographic differences between groups of mothers taking various AEDs.

Sixty-eight infants (49.3%) had AED concentrations that were less than the lower limit of quantification. AED concentration was not greater than the lower limit of quantification for any infants breastfed by mothers taking carbamazepine, oxcarbazepine, valproic acid, or topiramate. Most levetiracetam (71.4%) and zonisamide (60.0%) concentrations in infants were less than the lower limit of quantification. Most lamotrigine concentrations in infants (88.6%) were greater than the lower limit of quantification.

The median percentage of infant-to-mother concentration was 28.9% for lamotrigine, 5.3% for levetiracetam, 44.2% for zonisamide, 5.7% for carbamazepine, 5.4% for carbamazepine epoxide, 0.3% for oxcarbazepine, 17.2% for topiramate, and 21.4% for valproic acid. Multiple linear regression models indicated that maternal concentration was significantly associated with lamotrigine concentration in infants, but not levetiracetam concentration in infants.

“Prior studies at delivery demonstrated that umbilical-cord concentrations were nearly equal to maternal concentrations, suggesting extensive placental passage to the fetus,” wrote Dr. Birnbaum and colleagues. “Therefore, the amount of AED exposure via breast milk is likely substantially lower than fetal exposure during pregnancy and appears unlikely to confer any additional risks beyond those that might be associated with exposure in pregnancy, especially given prior studies showing no adverse neurodevelopmental effects of breastfeeding while taking AEDs.”

The investigators acknowledged several limitations of their research, including the observational design of the MONEAD study. The amount of AED in participants’ breast milk is unknown, and the investigators could not calculate relative infant dosages. Only one blood sample was taken per infant, thus the results may not reflect infants’ total exposure over time.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Development funded the research. The authors reported receiving research support from various pharmaceutical companies.

[email protected]

SOURCE: Birnbaum AK et al. JAMA Neurol. 2019 Dec 30. doi: 10.1001/jamaneurol.2019.4443.

Antiepileptic drug (AED) exposure resulting from breastfeeding in infants is low, compared with exposure in mothers who took AEDs during pregnancy, according to a study published online ahead of print Dec. 30, 2019, in JAMA Neurology. The results may explain why previous research failed to find adverse neurodevelopmental effects of breastfeeding in infants whose mothers are undergoing AED treatment, said the authors.

“The results of this study add support to the general safety of breastfeeding by mothers with epilepsy who take AEDs,” wrote Angela K. Birnbaum, PhD, professor of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, and colleagues.
 

Investigators measured infants’ blood AED concentrations

To date, medical consensus about the safety of breastfeeding while the mother is taking AEDs has been elusive. Researchers have investigated breast milk concentrations of AEDs as surrogate markers of AED concentrations in children. Breast milk concentrations, however, do not account for differences in infant pharmacokinetic processes and thus could misrepresent AED exposure in children through breastfeeding.

Dr. Birnbaum and colleagues sought to measure blood concentrations of AEDs in mothers with epilepsy and the infants that they breastfed to achieve an objective measure of AED exposure through breastfeeding. They examined data collected from December 2012 to October 2016 in the prospective Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study. Eligible participants were pregnant women with epilepsy between the ages of 14 and 45 years whose pregnancies had progressed to fewer than 20 weeks’ gestational age and who had IQ scores greater than 70 points. Participants were followed up throughout pregnancy and for 9 months post partum. Children were enrolled at birth.

The investigators collected blood samples from mothers and infants who were breastfed at the same visit, which occurred at between 5 and 20 weeks after birth. The volume of ingested breast milk delivered through graduated feeding bottles each day and the total duration of all daily breastfeeding sessions were recorded. For infants, blood samples were collected from the plantar surface of the heel and stored as dried blood spots on filter paper. The study’s primary endpoint was the percentage of infant-to-mother concentration of AEDs. Concentrations of AEDs in infants at less than the lower limit of quantification were assessed as half of the lower limit.
 

Exposure in utero may be greater than exposure through breast milk

In all, the researchers enrolled 351 pregnant women with epilepsy into the study and collected data on 345 infants. Two hundred twenty-two (64.3%) of the infants were breastfed, and 146 (42.3%) had AED concentrations available. After excluding outliers and mothers with missing concentration data, Dr. Birnbaum and colleagues included 164 matching infant-mother concentration pairs in their analysis (i.e., of 135 mothers and 138 infants). Approximately 52% of the infants were female, and their median age at blood collection was 13 weeks. The mothers’ median age was 32 years. About 82% of mothers were receiving monotherapy. The investigators found no demographic differences between groups of mothers taking various AEDs.

Sixty-eight infants (49.3%) had AED concentrations that were less than the lower limit of quantification. AED concentration was not greater than the lower limit of quantification for any infants breastfed by mothers taking carbamazepine, oxcarbazepine, valproic acid, or topiramate. Most levetiracetam (71.4%) and zonisamide (60.0%) concentrations in infants were less than the lower limit of quantification. Most lamotrigine concentrations in infants (88.6%) were greater than the lower limit of quantification.

The median percentage of infant-to-mother concentration was 28.9% for lamotrigine, 5.3% for levetiracetam, 44.2% for zonisamide, 5.7% for carbamazepine, 5.4% for carbamazepine epoxide, 0.3% for oxcarbazepine, 17.2% for topiramate, and 21.4% for valproic acid. Multiple linear regression models indicated that maternal concentration was significantly associated with lamotrigine concentration in infants, but not levetiracetam concentration in infants.

“Prior studies at delivery demonstrated that umbilical-cord concentrations were nearly equal to maternal concentrations, suggesting extensive placental passage to the fetus,” wrote Dr. Birnbaum and colleagues. “Therefore, the amount of AED exposure via breast milk is likely substantially lower than fetal exposure during pregnancy and appears unlikely to confer any additional risks beyond those that might be associated with exposure in pregnancy, especially given prior studies showing no adverse neurodevelopmental effects of breastfeeding while taking AEDs.”

The investigators acknowledged several limitations of their research, including the observational design of the MONEAD study. The amount of AED in participants’ breast milk is unknown, and the investigators could not calculate relative infant dosages. Only one blood sample was taken per infant, thus the results may not reflect infants’ total exposure over time.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Development funded the research. The authors reported receiving research support from various pharmaceutical companies.

[email protected]

SOURCE: Birnbaum AK et al. JAMA Neurol. 2019 Dec 30. doi: 10.1001/jamaneurol.2019.4443.

Antiepileptic drug (AED) exposure resulting from breastfeeding in infants is low, compared with exposure in mothers who took AEDs during pregnancy, according to a study published online ahead of print Dec. 30, 2019, in JAMA Neurology. The results may explain why previous research failed to find adverse neurodevelopmental effects of breastfeeding in infants whose mothers are undergoing AED treatment, said the authors.

“The results of this study add support to the general safety of breastfeeding by mothers with epilepsy who take AEDs,” wrote Angela K. Birnbaum, PhD, professor of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, and colleagues.
 

Investigators measured infants’ blood AED concentrations

To date, medical consensus about the safety of breastfeeding while the mother is taking AEDs has been elusive. Researchers have investigated breast milk concentrations of AEDs as surrogate markers of AED concentrations in children. Breast milk concentrations, however, do not account for differences in infant pharmacokinetic processes and thus could misrepresent AED exposure in children through breastfeeding.

Dr. Birnbaum and colleagues sought to measure blood concentrations of AEDs in mothers with epilepsy and the infants that they breastfed to achieve an objective measure of AED exposure through breastfeeding. They examined data collected from December 2012 to October 2016 in the prospective Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study. Eligible participants were pregnant women with epilepsy between the ages of 14 and 45 years whose pregnancies had progressed to fewer than 20 weeks’ gestational age and who had IQ scores greater than 70 points. Participants were followed up throughout pregnancy and for 9 months post partum. Children were enrolled at birth.

The investigators collected blood samples from mothers and infants who were breastfed at the same visit, which occurred at between 5 and 20 weeks after birth. The volume of ingested breast milk delivered through graduated feeding bottles each day and the total duration of all daily breastfeeding sessions were recorded. For infants, blood samples were collected from the plantar surface of the heel and stored as dried blood spots on filter paper. The study’s primary endpoint was the percentage of infant-to-mother concentration of AEDs. Concentrations of AEDs in infants at less than the lower limit of quantification were assessed as half of the lower limit.
 

Exposure in utero may be greater than exposure through breast milk

In all, the researchers enrolled 351 pregnant women with epilepsy into the study and collected data on 345 infants. Two hundred twenty-two (64.3%) of the infants were breastfed, and 146 (42.3%) had AED concentrations available. After excluding outliers and mothers with missing concentration data, Dr. Birnbaum and colleagues included 164 matching infant-mother concentration pairs in their analysis (i.e., of 135 mothers and 138 infants). Approximately 52% of the infants were female, and their median age at blood collection was 13 weeks. The mothers’ median age was 32 years. About 82% of mothers were receiving monotherapy. The investigators found no demographic differences between groups of mothers taking various AEDs.

Sixty-eight infants (49.3%) had AED concentrations that were less than the lower limit of quantification. AED concentration was not greater than the lower limit of quantification for any infants breastfed by mothers taking carbamazepine, oxcarbazepine, valproic acid, or topiramate. Most levetiracetam (71.4%) and zonisamide (60.0%) concentrations in infants were less than the lower limit of quantification. Most lamotrigine concentrations in infants (88.6%) were greater than the lower limit of quantification.

The median percentage of infant-to-mother concentration was 28.9% for lamotrigine, 5.3% for levetiracetam, 44.2% for zonisamide, 5.7% for carbamazepine, 5.4% for carbamazepine epoxide, 0.3% for oxcarbazepine, 17.2% for topiramate, and 21.4% for valproic acid. Multiple linear regression models indicated that maternal concentration was significantly associated with lamotrigine concentration in infants, but not levetiracetam concentration in infants.

“Prior studies at delivery demonstrated that umbilical-cord concentrations were nearly equal to maternal concentrations, suggesting extensive placental passage to the fetus,” wrote Dr. Birnbaum and colleagues. “Therefore, the amount of AED exposure via breast milk is likely substantially lower than fetal exposure during pregnancy and appears unlikely to confer any additional risks beyond those that might be associated with exposure in pregnancy, especially given prior studies showing no adverse neurodevelopmental effects of breastfeeding while taking AEDs.”

The investigators acknowledged several limitations of their research, including the observational design of the MONEAD study. The amount of AED in participants’ breast milk is unknown, and the investigators could not calculate relative infant dosages. Only one blood sample was taken per infant, thus the results may not reflect infants’ total exposure over time.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Development funded the research. The authors reported receiving research support from various pharmaceutical companies.

[email protected]

SOURCE: Birnbaum AK et al. JAMA Neurol. 2019 Dec 30. doi: 10.1001/jamaneurol.2019.4443.

PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.

Mitchel L. Zoler/MDedge News

This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.

Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.

He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).

“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.

He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.

Mitchel L. Zoler/MDedge News

A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.

Mitchel L. Zoler/MDedge News

“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.

The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.

The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.

The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).

In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)

“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.

“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”

Mitchel L. Zoler/MDedge News

“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”

Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.

[email protected]

SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.

PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.

Mitchel L. Zoler/MDedge News

This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.

Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.

He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).

“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.

He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.

Mitchel L. Zoler/MDedge News

A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.

Mitchel L. Zoler/MDedge News

“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.

The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.

The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.

The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).

In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)

“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.

“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”

Mitchel L. Zoler/MDedge News

“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”

Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.

[email protected]

SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.

PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.

Mitchel L. Zoler/MDedge News

This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.

Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.

He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).

“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.

He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.

Mitchel L. Zoler/MDedge News

A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.

Mitchel L. Zoler/MDedge News

“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.

The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.

The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.

The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).

In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)

“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.

“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”

Mitchel L. Zoler/MDedge News

“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”

Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.

[email protected]

SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.

MADRID – A growing recognition that atopic dermatitis (AD) patients on dupilumab are prone to develop a paradoxical head and neck erythema that’s clinically and histologically distinct from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.

She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.

A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.

“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.

Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.

The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.

She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.

The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.

“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).

Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.

This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).

Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.

“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.

French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.

Bruce Jancin/MDedge News

[email protected]

MADRID – A growing recognition that atopic dermatitis (AD) patients on dupilumab are prone to develop a paradoxical head and neck erythema that’s clinically and histologically distinct from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.

She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.

A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.

“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.

Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.

The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.

She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.

The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.

“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).

Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.

This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).

Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.

“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.

French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.

Bruce Jancin/MDedge News

[email protected]

MADRID – A growing recognition that atopic dermatitis (AD) patients on dupilumab are prone to develop a paradoxical head and neck erythema that’s clinically and histologically distinct from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.

She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.

A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.

“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.

Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.

The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.

She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.

The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.

“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).

Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.

This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).

Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.

“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.

French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.

Bruce Jancin/MDedge News

[email protected]

Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.¹ These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.² The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.

Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.³ Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”⁴

In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.⁵ Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.

None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).^3-5

Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.⁶ Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.² Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.⁷ Factors that promote the adoption of organizational interventions such as NICHE have been identified.⁸ The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.⁹

Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.

Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.

Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.¹ These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.² The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.

Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.³ Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”⁴

In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.⁵ Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.

None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).^3-5

Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.⁶ Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.² Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.⁷ Factors that promote the adoption of organizational interventions such as NICHE have been identified.⁸ The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.⁹

Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.

Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.

Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.¹ These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.² The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.

Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.³ Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”⁴

In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.⁵ Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.

None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).^3-5

Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.⁶ Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.² Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.⁷ Factors that promote the adoption of organizational interventions such as NICHE have been identified.⁸ The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.⁹

Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.

Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.