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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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Current Issue
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.

Current Issue Reference

Housing Program Expansion Opens Doors to More Veterans

Article Type
Changed
Mon, 08/25/2025 - 14:10

TOPLINE:Expanding United States Department of Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) eligibility to veterans with other-than-honorable (OTH) discharge significantly increased their program enrollments without impacting services for those with honorable discharge. Emergency department visits increased for honorable discharge veterans while hospitalizations rose for both groups.

METHODOLOGY:

  • A quality improvement study following SQUIRE 2.0 reporting guidelines analyzed data from 129,873 veterans enrolled in HUD-VASH between June 1, 2019, and September 30, 2021.
  • Analysis included 127,876 veterans (98.5%) with honorable/general discharge and 1997 veterans (1.5%) with OTH discharge, with a mean age of 53.7 years.
  • Researchers utilized an interrupted time series design to compare program enrollments and healthcare utilization before (June 2019-December 2020) and after (January 2021-September 2021) policy implementation.
  • Data linkage between the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse enabled tracking of emergency department visits, hospitalizations, and primary care visits.
     

TAKEAWAY:

  • Monthly HUD-VASH enrollments showed a significant increase for OTH veterans after the policy change (difference in slopes, 1.90; 95% confidence interval [CI], 1.28-2.52), while honorable/general veterans experienced a non-significant increase (difference in slopes, 9.23; 95% CI, −20.35-38.79).
  • Emergency department visits demonstrated a significant increase for honorable/general veterans (change in slope, 0.24; 95% CI, 0.12-0.35) but not for OTH veterans (change in slope, 0.08; 
    95% CI, −0.12-0.28).
  • Hospitalizations significantly increased for both OTH veterans (change in slope, 0.098; 95% CI, 0.009-0.170) and honorable/general veterans (change in slope, 0.078; 95% CI, 0.004-0.060).
  • Primary care visits showed no significant changes for either group after the policy implementation (OTH: change in slope, −0.12; 95% CI, −0.65-0.42; honorable/general: change in slope, 0.20; 
    95% CI, −0.13-0.53).

IN PRACTICE:“Expanding HUD-VASH eligibility increased access to housing and social support for OTH veterans without disrupting services for those with honorable discharges,” the authors reported. “Efforts should focus on improving access to connecting OTH veterans with clinical services outside of HUD-VASH.”

SOURCE:The study was led by Thomas F. Nubong, MD, Center of Innovation for Long-Term Services and Supports, Providence Veterans Affairs Medical Center in Providence. It was published online on August 5 in JAMA Network Open.

LIMITATIONS: According to the authors, the study period overlapped with the COVID-19 pandemic, potentially affecting results. Additionally, staff training on the policy change varied across US Department of Veterans Affairs (VA) sites, introducing implementation inconsistencies. The single-group interrupted time series design, while effective for tracking temporal trends, limited formal comparisons between discharge groups.

DISCLOSURES: The analyses were conducted under the VA Homeless Programs Office with operational funding support. Jack Tsai, PhD, and Eric Jutkowitz, PhD, reported being principal investigators of a VA Merit study on the Impact of COVID-19 for the HUD-VASH program. James L. Rudolph, MD, reported receiving grants from Icosavax outside the submitted work and being a United States government employee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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TOPLINE:Expanding United States Department of Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) eligibility to veterans with other-than-honorable (OTH) discharge significantly increased their program enrollments without impacting services for those with honorable discharge. Emergency department visits increased for honorable discharge veterans while hospitalizations rose for both groups.

METHODOLOGY:

  • A quality improvement study following SQUIRE 2.0 reporting guidelines analyzed data from 129,873 veterans enrolled in HUD-VASH between June 1, 2019, and September 30, 2021.
  • Analysis included 127,876 veterans (98.5%) with honorable/general discharge and 1997 veterans (1.5%) with OTH discharge, with a mean age of 53.7 years.
  • Researchers utilized an interrupted time series design to compare program enrollments and healthcare utilization before (June 2019-December 2020) and after (January 2021-September 2021) policy implementation.
  • Data linkage between the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse enabled tracking of emergency department visits, hospitalizations, and primary care visits.
     

TAKEAWAY:

  • Monthly HUD-VASH enrollments showed a significant increase for OTH veterans after the policy change (difference in slopes, 1.90; 95% confidence interval [CI], 1.28-2.52), while honorable/general veterans experienced a non-significant increase (difference in slopes, 9.23; 95% CI, −20.35-38.79).
  • Emergency department visits demonstrated a significant increase for honorable/general veterans (change in slope, 0.24; 95% CI, 0.12-0.35) but not for OTH veterans (change in slope, 0.08; 
    95% CI, −0.12-0.28).
  • Hospitalizations significantly increased for both OTH veterans (change in slope, 0.098; 95% CI, 0.009-0.170) and honorable/general veterans (change in slope, 0.078; 95% CI, 0.004-0.060).
  • Primary care visits showed no significant changes for either group after the policy implementation (OTH: change in slope, −0.12; 95% CI, −0.65-0.42; honorable/general: change in slope, 0.20; 
    95% CI, −0.13-0.53).

IN PRACTICE:“Expanding HUD-VASH eligibility increased access to housing and social support for OTH veterans without disrupting services for those with honorable discharges,” the authors reported. “Efforts should focus on improving access to connecting OTH veterans with clinical services outside of HUD-VASH.”

SOURCE:The study was led by Thomas F. Nubong, MD, Center of Innovation for Long-Term Services and Supports, Providence Veterans Affairs Medical Center in Providence. It was published online on August 5 in JAMA Network Open.

LIMITATIONS: According to the authors, the study period overlapped with the COVID-19 pandemic, potentially affecting results. Additionally, staff training on the policy change varied across US Department of Veterans Affairs (VA) sites, introducing implementation inconsistencies. The single-group interrupted time series design, while effective for tracking temporal trends, limited formal comparisons between discharge groups.

DISCLOSURES: The analyses were conducted under the VA Homeless Programs Office with operational funding support. Jack Tsai, PhD, and Eric Jutkowitz, PhD, reported being principal investigators of a VA Merit study on the Impact of COVID-19 for the HUD-VASH program. James L. Rudolph, MD, reported receiving grants from Icosavax outside the submitted work and being a United States government employee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE:Expanding United States Department of Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) eligibility to veterans with other-than-honorable (OTH) discharge significantly increased their program enrollments without impacting services for those with honorable discharge. Emergency department visits increased for honorable discharge veterans while hospitalizations rose for both groups.

METHODOLOGY:

  • A quality improvement study following SQUIRE 2.0 reporting guidelines analyzed data from 129,873 veterans enrolled in HUD-VASH between June 1, 2019, and September 30, 2021.
  • Analysis included 127,876 veterans (98.5%) with honorable/general discharge and 1997 veterans (1.5%) with OTH discharge, with a mean age of 53.7 years.
  • Researchers utilized an interrupted time series design to compare program enrollments and healthcare utilization before (June 2019-December 2020) and after (January 2021-September 2021) policy implementation.
  • Data linkage between the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse enabled tracking of emergency department visits, hospitalizations, and primary care visits.
     

TAKEAWAY:

  • Monthly HUD-VASH enrollments showed a significant increase for OTH veterans after the policy change (difference in slopes, 1.90; 95% confidence interval [CI], 1.28-2.52), while honorable/general veterans experienced a non-significant increase (difference in slopes, 9.23; 95% CI, −20.35-38.79).
  • Emergency department visits demonstrated a significant increase for honorable/general veterans (change in slope, 0.24; 95% CI, 0.12-0.35) but not for OTH veterans (change in slope, 0.08; 
    95% CI, −0.12-0.28).
  • Hospitalizations significantly increased for both OTH veterans (change in slope, 0.098; 95% CI, 0.009-0.170) and honorable/general veterans (change in slope, 0.078; 95% CI, 0.004-0.060).
  • Primary care visits showed no significant changes for either group after the policy implementation (OTH: change in slope, −0.12; 95% CI, −0.65-0.42; honorable/general: change in slope, 0.20; 
    95% CI, −0.13-0.53).

IN PRACTICE:“Expanding HUD-VASH eligibility increased access to housing and social support for OTH veterans without disrupting services for those with honorable discharges,” the authors reported. “Efforts should focus on improving access to connecting OTH veterans with clinical services outside of HUD-VASH.”

SOURCE:The study was led by Thomas F. Nubong, MD, Center of Innovation for Long-Term Services and Supports, Providence Veterans Affairs Medical Center in Providence. It was published online on August 5 in JAMA Network Open.

LIMITATIONS: According to the authors, the study period overlapped with the COVID-19 pandemic, potentially affecting results. Additionally, staff training on the policy change varied across US Department of Veterans Affairs (VA) sites, introducing implementation inconsistencies. The single-group interrupted time series design, while effective for tracking temporal trends, limited formal comparisons between discharge groups.

DISCLOSURES: The analyses were conducted under the VA Homeless Programs Office with operational funding support. Jack Tsai, PhD, and Eric Jutkowitz, PhD, reported being principal investigators of a VA Merit study on the Impact of COVID-19 for the HUD-VASH program. James L. Rudolph, MD, reported receiving grants from Icosavax outside the submitted work and being a United States government employee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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Mon, 08/25/2025 - 14:02

Critical Access for Veterans Bill Would Undermine VA Care

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The Critical Access for Veterans Care ActS.1868, introduced in May by Senators Kevin Cramer (R-ND) and Tim Sheehy (R-MT), would fundamentally reshape how veterans living in rural communities access private health care. The legislation establishes a new paradigm impacting veterans enrolled in US Department of Veterans Affairs (VA) health care who reside within 35 miles of any Centers for Medicare & Medicaid Services-designated Critical Access Hospital (CAH) or affiliated clinic. The bill would allow veterans unprecedented autonomy to self-refer directly to these facilities.

However, despite its seemingly straightforward title, the bill will not expedite care delivery, reduce travel burdens, or enhance network critical care capacity for veterans living in rural areas. Instead, the bill would further privatize veteran health care delivery by permitting veterans within this geographic radius to independently pursue care at CAHs and clinics without prior authorization. The legislation would establish a parallel referral system that erodes the Veterans Community Care Program (VCCP) eligibility determinations that were meticulously developed under the VA MISSION Act of 2018.

Some lawmakers have repeatedly pushed to eliminate VA's authorization role in the past 6 years, seeking to grant unrestricted private sector access to various veteran populations, particularly those requiring mental health services. Sponsors of the current bill are explicitly pursuing this same objective, characterizing VA authorization as an “unnecessary roadblock” that should be removed. However, this characterization misrepresents the actual function and value of the authorization process.

Over the past 6 years, provisions in the VA MISSION Act and other laws for predetermining veteran eligibility for private care have provided veterans with broad access while maintaining oversight and accountability. Enrolled veterans may receive comprehensive emergency medical and psychiatric care at any health care facility, including CAHs. They are guaranteed unrestricted walk-in urgent care access anywhere in the country. Veterans can also obtain outpatient and inpatient services through VCCP clinicians when they meet the following established access criteria: VA facilities exceed 30-minute travel times for primary and mental health services or 60 minutes for specialty care, or when appointment wait times surpass 20 days for primary/mental health care or 28 days for specialty services. Nearly half of covered veterans used this option in FY2023. 

This bill does more than upend the established paradigm of VCCP eligibility requirements: it also eliminates the critical function of utilization review and accountability. Its passage would establish a dangerous precedent. By eliminating drive time and wait time eligibility standards and simultaneously removing VA’s ability to manage use, the bill generates powerful political momentum to extend identical provisions to all enrolled veterans. Furthermore, this legislation could specifically precipitate the downsizing or closure of VA community-based outpatient clinics (CBOCs) in areas served by CAHs. North Dakota, for example, operates 5 CBOCs that could be affected. Veterans who live in rural areas within the standard 30- to 60-minute drive time of a CBOC and can secure appointments within the established 20- to 28-day timeframes would no longer be subject to the same eligibility criteria that govern all covered veterans.

The Veterans Healthcare Policy Institute (VHPI) has serious reservations about legislation that eliminates VA's indispensable authorization and referral functions for supplemental private care. Founded in 2016, the VHPI is a nonprofit, nonpartisan organization dedicated to analyzing health care, disability compensation, and benefits for US veterans and their families. It provides fact-based research to educate the public and improve care quality both within and outside the VA.

New initiatives threaten to drastically reduce veterans' health and disability benefits through staff cuts and service reductions that will limit access to earned benefits and life-sustaining health care. Attacks against the VA also threaten to erode the training that produces new cohorts of health professionals, dramatically exacerbating the nation’s already dire shortages of physicians, nurses, psychologists and social workers. 

VHPI’s coverage of Veterans Health Administration downsizing within rural health care provides important context. Starting with a comprehensive 15-page white paper published in 2024, VHPI has consistently highlighted how veterans living in rural communities face the same health care access challenges as all rural Americans—living in regions with severe shortages of health care facilities, professionals, and support staff. Lawmakers who assume veterans living in rural areas will experience shorter wait times and drive distances through private sector care fundamentally misunderstand these systemic issues 

VHPI is committed to rigorously scrutinize policies that may compromise high quality care for veterans, especially those living in rural areas.  The organization recently examined the flawed assumptions underlying these misguided policies. On August 12, VHPI released an in-depth analysis of private sector  clinicians’ capacity to care for veterans in across all 50 states titled “Veterans’ Health Care Choice—Myth or Reality? A State- by- State Reality Check of the False Promise of VA Privatization.” This analysis revealed that, in most states, and in all rural states, the private sector system was struggling to meet even the basic needs of non-veterans. As one long time VA expert stated, to imagine that the system could absorb an influx of millions of veterans – particularly when new cuts to Medicaid and other healthcare funding are implemented, is “delusional.”

 

Russell Lemle and Suzanne Gordon are senior policy analysts at the Veterans Healthcare Policy Institute. Suzanne Gordon is author of Wounds of War.

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The Critical Access for Veterans Care ActS.1868, introduced in May by Senators Kevin Cramer (R-ND) and Tim Sheehy (R-MT), would fundamentally reshape how veterans living in rural communities access private health care. The legislation establishes a new paradigm impacting veterans enrolled in US Department of Veterans Affairs (VA) health care who reside within 35 miles of any Centers for Medicare & Medicaid Services-designated Critical Access Hospital (CAH) or affiliated clinic. The bill would allow veterans unprecedented autonomy to self-refer directly to these facilities.

However, despite its seemingly straightforward title, the bill will not expedite care delivery, reduce travel burdens, or enhance network critical care capacity for veterans living in rural areas. Instead, the bill would further privatize veteran health care delivery by permitting veterans within this geographic radius to independently pursue care at CAHs and clinics without prior authorization. The legislation would establish a parallel referral system that erodes the Veterans Community Care Program (VCCP) eligibility determinations that were meticulously developed under the VA MISSION Act of 2018.

Some lawmakers have repeatedly pushed to eliminate VA's authorization role in the past 6 years, seeking to grant unrestricted private sector access to various veteran populations, particularly those requiring mental health services. Sponsors of the current bill are explicitly pursuing this same objective, characterizing VA authorization as an “unnecessary roadblock” that should be removed. However, this characterization misrepresents the actual function and value of the authorization process.

Over the past 6 years, provisions in the VA MISSION Act and other laws for predetermining veteran eligibility for private care have provided veterans with broad access while maintaining oversight and accountability. Enrolled veterans may receive comprehensive emergency medical and psychiatric care at any health care facility, including CAHs. They are guaranteed unrestricted walk-in urgent care access anywhere in the country. Veterans can also obtain outpatient and inpatient services through VCCP clinicians when they meet the following established access criteria: VA facilities exceed 30-minute travel times for primary and mental health services or 60 minutes for specialty care, or when appointment wait times surpass 20 days for primary/mental health care or 28 days for specialty services. Nearly half of covered veterans used this option in FY2023. 

This bill does more than upend the established paradigm of VCCP eligibility requirements: it also eliminates the critical function of utilization review and accountability. Its passage would establish a dangerous precedent. By eliminating drive time and wait time eligibility standards and simultaneously removing VA’s ability to manage use, the bill generates powerful political momentum to extend identical provisions to all enrolled veterans. Furthermore, this legislation could specifically precipitate the downsizing or closure of VA community-based outpatient clinics (CBOCs) in areas served by CAHs. North Dakota, for example, operates 5 CBOCs that could be affected. Veterans who live in rural areas within the standard 30- to 60-minute drive time of a CBOC and can secure appointments within the established 20- to 28-day timeframes would no longer be subject to the same eligibility criteria that govern all covered veterans.

The Veterans Healthcare Policy Institute (VHPI) has serious reservations about legislation that eliminates VA's indispensable authorization and referral functions for supplemental private care. Founded in 2016, the VHPI is a nonprofit, nonpartisan organization dedicated to analyzing health care, disability compensation, and benefits for US veterans and their families. It provides fact-based research to educate the public and improve care quality both within and outside the VA.

New initiatives threaten to drastically reduce veterans' health and disability benefits through staff cuts and service reductions that will limit access to earned benefits and life-sustaining health care. Attacks against the VA also threaten to erode the training that produces new cohorts of health professionals, dramatically exacerbating the nation’s already dire shortages of physicians, nurses, psychologists and social workers. 

VHPI’s coverage of Veterans Health Administration downsizing within rural health care provides important context. Starting with a comprehensive 15-page white paper published in 2024, VHPI has consistently highlighted how veterans living in rural communities face the same health care access challenges as all rural Americans—living in regions with severe shortages of health care facilities, professionals, and support staff. Lawmakers who assume veterans living in rural areas will experience shorter wait times and drive distances through private sector care fundamentally misunderstand these systemic issues 

VHPI is committed to rigorously scrutinize policies that may compromise high quality care for veterans, especially those living in rural areas.  The organization recently examined the flawed assumptions underlying these misguided policies. On August 12, VHPI released an in-depth analysis of private sector  clinicians’ capacity to care for veterans in across all 50 states titled “Veterans’ Health Care Choice—Myth or Reality? A State- by- State Reality Check of the False Promise of VA Privatization.” This analysis revealed that, in most states, and in all rural states, the private sector system was struggling to meet even the basic needs of non-veterans. As one long time VA expert stated, to imagine that the system could absorb an influx of millions of veterans – particularly when new cuts to Medicaid and other healthcare funding are implemented, is “delusional.”

 

Russell Lemle and Suzanne Gordon are senior policy analysts at the Veterans Healthcare Policy Institute. Suzanne Gordon is author of Wounds of War.

The Critical Access for Veterans Care ActS.1868, introduced in May by Senators Kevin Cramer (R-ND) and Tim Sheehy (R-MT), would fundamentally reshape how veterans living in rural communities access private health care. The legislation establishes a new paradigm impacting veterans enrolled in US Department of Veterans Affairs (VA) health care who reside within 35 miles of any Centers for Medicare & Medicaid Services-designated Critical Access Hospital (CAH) or affiliated clinic. The bill would allow veterans unprecedented autonomy to self-refer directly to these facilities.

However, despite its seemingly straightforward title, the bill will not expedite care delivery, reduce travel burdens, or enhance network critical care capacity for veterans living in rural areas. Instead, the bill would further privatize veteran health care delivery by permitting veterans within this geographic radius to independently pursue care at CAHs and clinics without prior authorization. The legislation would establish a parallel referral system that erodes the Veterans Community Care Program (VCCP) eligibility determinations that were meticulously developed under the VA MISSION Act of 2018.

Some lawmakers have repeatedly pushed to eliminate VA's authorization role in the past 6 years, seeking to grant unrestricted private sector access to various veteran populations, particularly those requiring mental health services. Sponsors of the current bill are explicitly pursuing this same objective, characterizing VA authorization as an “unnecessary roadblock” that should be removed. However, this characterization misrepresents the actual function and value of the authorization process.

Over the past 6 years, provisions in the VA MISSION Act and other laws for predetermining veteran eligibility for private care have provided veterans with broad access while maintaining oversight and accountability. Enrolled veterans may receive comprehensive emergency medical and psychiatric care at any health care facility, including CAHs. They are guaranteed unrestricted walk-in urgent care access anywhere in the country. Veterans can also obtain outpatient and inpatient services through VCCP clinicians when they meet the following established access criteria: VA facilities exceed 30-minute travel times for primary and mental health services or 60 minutes for specialty care, or when appointment wait times surpass 20 days for primary/mental health care or 28 days for specialty services. Nearly half of covered veterans used this option in FY2023. 

This bill does more than upend the established paradigm of VCCP eligibility requirements: it also eliminates the critical function of utilization review and accountability. Its passage would establish a dangerous precedent. By eliminating drive time and wait time eligibility standards and simultaneously removing VA’s ability to manage use, the bill generates powerful political momentum to extend identical provisions to all enrolled veterans. Furthermore, this legislation could specifically precipitate the downsizing or closure of VA community-based outpatient clinics (CBOCs) in areas served by CAHs. North Dakota, for example, operates 5 CBOCs that could be affected. Veterans who live in rural areas within the standard 30- to 60-minute drive time of a CBOC and can secure appointments within the established 20- to 28-day timeframes would no longer be subject to the same eligibility criteria that govern all covered veterans.

The Veterans Healthcare Policy Institute (VHPI) has serious reservations about legislation that eliminates VA's indispensable authorization and referral functions for supplemental private care. Founded in 2016, the VHPI is a nonprofit, nonpartisan organization dedicated to analyzing health care, disability compensation, and benefits for US veterans and their families. It provides fact-based research to educate the public and improve care quality both within and outside the VA.

New initiatives threaten to drastically reduce veterans' health and disability benefits through staff cuts and service reductions that will limit access to earned benefits and life-sustaining health care. Attacks against the VA also threaten to erode the training that produces new cohorts of health professionals, dramatically exacerbating the nation’s already dire shortages of physicians, nurses, psychologists and social workers. 

VHPI’s coverage of Veterans Health Administration downsizing within rural health care provides important context. Starting with a comprehensive 15-page white paper published in 2024, VHPI has consistently highlighted how veterans living in rural communities face the same health care access challenges as all rural Americans—living in regions with severe shortages of health care facilities, professionals, and support staff. Lawmakers who assume veterans living in rural areas will experience shorter wait times and drive distances through private sector care fundamentally misunderstand these systemic issues 

VHPI is committed to rigorously scrutinize policies that may compromise high quality care for veterans, especially those living in rural areas.  The organization recently examined the flawed assumptions underlying these misguided policies. On August 12, VHPI released an in-depth analysis of private sector  clinicians’ capacity to care for veterans in across all 50 states titled “Veterans’ Health Care Choice—Myth or Reality? A State- by- State Reality Check of the False Promise of VA Privatization.” This analysis revealed that, in most states, and in all rural states, the private sector system was struggling to meet even the basic needs of non-veterans. As one long time VA expert stated, to imagine that the system could absorb an influx of millions of veterans – particularly when new cuts to Medicaid and other healthcare funding are implemented, is “delusional.”

 

Russell Lemle and Suzanne Gordon are senior policy analysts at the Veterans Healthcare Policy Institute. Suzanne Gordon is author of Wounds of War.

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Mon, 08/25/2025 - 12:18

Weight Loss Before Military Training May Cut Injury Risk

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Tue, 08/19/2025 - 14:14

TOPLINE:

Army recruits who lost excess weight to enter military training experienced fewer musculoskeletal injuries (MSKIs), particularly in the lower extremities, during basic combat training than those who did not lose weight to join the service.

METHODOLOGY:

  • The nation’s obesity epidemic means that fewer individuals meet the US Army’s weight and body-fat standards for entering basic combat training. Only 29% of 17- to 24-year-olds in the country would have qualified to join the military in 2018, with overweight and obesity among the leading disqualifying factors.
  • Researchers analyzed data from 3168 Army trainees (mean age, 20.96 years; 62.34% men; mean maximum-ever BMI, 26.71) to examine the association between weight loss before enlistment and rates of MSKI during basic combat training.
  • Trainees completed a baseline questionnaire that asked whether the person lost weight to enter the Army and included follow-up questions about the amount of weight lost, duration of weight loss, methods used, and prior physical activity.
  • MSKIs were classified as any injury to the musculoskeletal system and further categorized by body region (lower extremities, upper extremities, spine/back, and other areas, including the torso and head/neck).
  • Researchers identified MSKIs from medical records collected throughout basic combat training and for up to 6 weeks afterward to capture injuries that occurred during training but were documented only after its completion.

TAKEAWAY:

  • Overall, 829 trainees (26.16%) reported losing weight to enter the Army, and they tended to have higher mean maximum-ever BMI, body-fat percentage, and lean mass compared with those who did not lose weight to join the service. The mean weight loss was 9.06 kg at a rate of 1.27 kg/wk among the 723 trainees with complete data.
  • The most commonly reported weight-loss methods were exercising more (83.7%), changing diet (61.0%), skipping meals (39.3%), and sweating using a sauna or rubber suit (25.6%).
  • Trainees who lost weight to join the service had a lower risk of any MSKI (hazard ratio [HR], 0.86) and lower extremity MSKIs (HR, 0.84) during training than those who did not lose weight to enter the Army. No difference was found between the two groups in the risk of upper extremity, spine/back, or other MSKIs.
  • Among trainees who lost weight to join the Army, the amount of time it took to lose weight was not associated with the risk for any MSKI or region-specific MSKIs.

IN PRACTICE:

“The findings highlight that losing excess weight before entering military training may reduce MSKI risk for incoming recruits, enforcing the benefits of healthy weight loss programs,” the authors wrote.

SOURCE:

The study, led by Vy T. Nguyen, MS, DSc, Military Performance Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts, was published online in Obesity .

LIMITATIONS: 

The study did not assess whether the association between weight loss and the rate of MSKIs persisted over long-term military service. How the two most frequently reported weight loss methods — increased exercise and dietary changes — may have influenced the observed association remains unclear. Medical records may not have captured all MSKIs if trainees did not seek medical care due to concerns about graduating on time or being placed on limited duty.

DISCLOSURES:

The study was supported by the US Army Medical Research and Development Command’s Military Operational Medicine Program. Two authors received support from the funder.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com

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TOPLINE:

Army recruits who lost excess weight to enter military training experienced fewer musculoskeletal injuries (MSKIs), particularly in the lower extremities, during basic combat training than those who did not lose weight to join the service.

METHODOLOGY:

  • The nation’s obesity epidemic means that fewer individuals meet the US Army’s weight and body-fat standards for entering basic combat training. Only 29% of 17- to 24-year-olds in the country would have qualified to join the military in 2018, with overweight and obesity among the leading disqualifying factors.
  • Researchers analyzed data from 3168 Army trainees (mean age, 20.96 years; 62.34% men; mean maximum-ever BMI, 26.71) to examine the association between weight loss before enlistment and rates of MSKI during basic combat training.
  • Trainees completed a baseline questionnaire that asked whether the person lost weight to enter the Army and included follow-up questions about the amount of weight lost, duration of weight loss, methods used, and prior physical activity.
  • MSKIs were classified as any injury to the musculoskeletal system and further categorized by body region (lower extremities, upper extremities, spine/back, and other areas, including the torso and head/neck).
  • Researchers identified MSKIs from medical records collected throughout basic combat training and for up to 6 weeks afterward to capture injuries that occurred during training but were documented only after its completion.

TAKEAWAY:

  • Overall, 829 trainees (26.16%) reported losing weight to enter the Army, and they tended to have higher mean maximum-ever BMI, body-fat percentage, and lean mass compared with those who did not lose weight to join the service. The mean weight loss was 9.06 kg at a rate of 1.27 kg/wk among the 723 trainees with complete data.
  • The most commonly reported weight-loss methods were exercising more (83.7%), changing diet (61.0%), skipping meals (39.3%), and sweating using a sauna or rubber suit (25.6%).
  • Trainees who lost weight to join the service had a lower risk of any MSKI (hazard ratio [HR], 0.86) and lower extremity MSKIs (HR, 0.84) during training than those who did not lose weight to enter the Army. No difference was found between the two groups in the risk of upper extremity, spine/back, or other MSKIs.
  • Among trainees who lost weight to join the Army, the amount of time it took to lose weight was not associated with the risk for any MSKI or region-specific MSKIs.

IN PRACTICE:

“The findings highlight that losing excess weight before entering military training may reduce MSKI risk for incoming recruits, enforcing the benefits of healthy weight loss programs,” the authors wrote.

SOURCE:

The study, led by Vy T. Nguyen, MS, DSc, Military Performance Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts, was published online in Obesity .

LIMITATIONS: 

The study did not assess whether the association between weight loss and the rate of MSKIs persisted over long-term military service. How the two most frequently reported weight loss methods — increased exercise and dietary changes — may have influenced the observed association remains unclear. Medical records may not have captured all MSKIs if trainees did not seek medical care due to concerns about graduating on time or being placed on limited duty.

DISCLOSURES:

The study was supported by the US Army Medical Research and Development Command’s Military Operational Medicine Program. Two authors received support from the funder.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com

TOPLINE:

Army recruits who lost excess weight to enter military training experienced fewer musculoskeletal injuries (MSKIs), particularly in the lower extremities, during basic combat training than those who did not lose weight to join the service.

METHODOLOGY:

  • The nation’s obesity epidemic means that fewer individuals meet the US Army’s weight and body-fat standards for entering basic combat training. Only 29% of 17- to 24-year-olds in the country would have qualified to join the military in 2018, with overweight and obesity among the leading disqualifying factors.
  • Researchers analyzed data from 3168 Army trainees (mean age, 20.96 years; 62.34% men; mean maximum-ever BMI, 26.71) to examine the association between weight loss before enlistment and rates of MSKI during basic combat training.
  • Trainees completed a baseline questionnaire that asked whether the person lost weight to enter the Army and included follow-up questions about the amount of weight lost, duration of weight loss, methods used, and prior physical activity.
  • MSKIs were classified as any injury to the musculoskeletal system and further categorized by body region (lower extremities, upper extremities, spine/back, and other areas, including the torso and head/neck).
  • Researchers identified MSKIs from medical records collected throughout basic combat training and for up to 6 weeks afterward to capture injuries that occurred during training but were documented only after its completion.

TAKEAWAY:

  • Overall, 829 trainees (26.16%) reported losing weight to enter the Army, and they tended to have higher mean maximum-ever BMI, body-fat percentage, and lean mass compared with those who did not lose weight to join the service. The mean weight loss was 9.06 kg at a rate of 1.27 kg/wk among the 723 trainees with complete data.
  • The most commonly reported weight-loss methods were exercising more (83.7%), changing diet (61.0%), skipping meals (39.3%), and sweating using a sauna or rubber suit (25.6%).
  • Trainees who lost weight to join the service had a lower risk of any MSKI (hazard ratio [HR], 0.86) and lower extremity MSKIs (HR, 0.84) during training than those who did not lose weight to enter the Army. No difference was found between the two groups in the risk of upper extremity, spine/back, or other MSKIs.
  • Among trainees who lost weight to join the Army, the amount of time it took to lose weight was not associated with the risk for any MSKI or region-specific MSKIs.

IN PRACTICE:

“The findings highlight that losing excess weight before entering military training may reduce MSKI risk for incoming recruits, enforcing the benefits of healthy weight loss programs,” the authors wrote.

SOURCE:

The study, led by Vy T. Nguyen, MS, DSc, Military Performance Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts, was published online in Obesity .

LIMITATIONS: 

The study did not assess whether the association between weight loss and the rate of MSKIs persisted over long-term military service. How the two most frequently reported weight loss methods — increased exercise and dietary changes — may have influenced the observed association remains unclear. Medical records may not have captured all MSKIs if trainees did not seek medical care due to concerns about graduating on time or being placed on limited duty.

DISCLOSURES:

The study was supported by the US Army Medical Research and Development Command’s Military Operational Medicine Program. Two authors received support from the funder.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com

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COPD CARE Academy: Design of Purposeful Training Guided by Implementation Strategies

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COPD CARE Academy: Design of Purposeful Training Guided by Implementation Strategies

Quality improvement (QI) initiatives within the US Department of Veterans Affairs (VA) play an important role in enhancing health care for veterans.1,2 While effective QI programs are often developed, veterans benefit only if they receive care at sites where the program is offered.3 It is estimated only 1% to 5% of patients receive benefit from evidence-based programs, limiting the opportunity for widespread impact.4,5

The Chronic Obstructive Pulmonary Disease (COPD) Coordinated Access to Reduce Exacerbations (CARE) Academy is a national training program designed to promote the adoption of a COPD primary care service.6 The Academy was created and iteratively refined by VA staff to include both clinical training emphasizing COPD management and program implementation strategies. Training programs such as COPD CARE are commonly described as a method to support adoption of health care services, but there is no consensus on a universal approach to training design.

This article describes COPD CARE training and implementation strategies (Table). The Academy began as a training program at 1 VA medical center (VAMC) and has expanded to 49 diverse VAMCs. The Academy illustrates how implementation strategies can be leveraged to develop pragmatic and impactful training. Highlights from the Academy's 9-year history are outlined in this article.

0825Fed-COPD-T1

COPD CARE

One in 4 veterans have a COPD diagnosis, and the 5-year mortality rate following a COPD flare is ≥ 50%.7,8 In 2015, a pharmacy resident designed and piloted COPD CARE, a program that used evidence-based practice to optimize management of the disease.9,10

The COPD CARE program is delivered by interprofessional team members. It includes a postacute care call completed 48 hours postdischarge, a wellness visit (face-to-face or virtual) 1 month postdischarge, and a follow-up visit scheduled 2 months postdischarge. Clinical pharmacist practitioners (CPPs) prescribe and collaborate with the COPD CARE health care team. Evidence-based practices embedded within COPD CARE include treatment optimization, symptom evaluation, severity staging, vaccination promotion, referrals, tobacco treatment, and comorbidity management.11-16 The initial COPD CARE pilot demonstrated promising results; patients received timely care and high rates of COPD best practices.11

Academy Design and Implementation

Initial COPD CARE training was tailored to the culture, context, and workflow of the William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin. Further service expansion required integration of implementation strategies that enable learners to apply and adapt content to fit different processes, staffing, and patient needs.

Formal Implementation Blueprint

A key aspect of the Academy is the integration of a formal implementation blueprint that includes training goals, scope, and key milestones to guide implementation. The Academy blueprint includes 4 phased training workbooks: (1) preimplementation support from local stakeholders; (2) integration of COPD CARE operational infrastructure into workflows; (3) preparing clinical champions; and (4) leading clinical training (Figure 1). Five weekly 1-hour synchronous virtual discussions are used for learning the workbook content that include learning objectives and opportunities to strategize how to overcome implementation barriers.

0825Fed-COPD-F1
Promoting and Facilitating Implementation

As clinicians apply content from the Academy to install informatics tools, coordinate clinical training, and build relationships across service lines, implementation barriers may occur. A learning collaborative allows peer-mentorship and shared problem solving. The Academy learning collaborative includes attendees across multiple VAMCs, allowing for diverse perspectives and cross-site learning. Within the field of dissemination and implementation science, this process of shared problem-solving to support individuals is referred to as implementation facilitation.17 Academy facilitators with prior experience provide a unique perspective and external facilitation from outside local VAMCs. Academy learners form local teams to engage in shared decision-making when applying Academy content. Following Academy completion, learning collaboratives continue to meet monthly to share clinical insights and operational updates.

Local Champions Promote Adaptability

One or more local champions were identified at each VAMC who were focused on the implementation of clinical training content and operational implementation of Academy content.18 Champions have helped develop adaptations of Academy content, such as integrating telehealth nursing within the COPD CARE referral process, which have become new best practices. Champions attend Academy sessions, which provide an opportunity to share adaptations to meet local needs.19

Using a Train-The-Trainer Model

Clinical training was designed to be dynamic and included video modeling, such as recorded examples of CPPs conducting COPD CARE visits and video clips highlighting clinical content. Each learner received a clinical workbook summarizing the content. The champion shares discussion questions to relate training content to the local clinical practice setting. The combination of live training, with videos of clinic visits and case-based discussion was intended to address differing learning styles. Clinical training was delivered using a train-the-trainer model led by the local champion, which allows clinicians with expertise to tailor their training. The use of a train-the-trainer model was intended to promote local buy-in and was often completed by frontline clinicians.

Informatics note templates provide clinicians with information needed to deliver training content during clinic visits. Direct hyperlinks to symptomatic scoring tools, resources to promote evidence-based medication optimization, and patient education resources were embedded within the electronic health record note templates. Direct links to consults for COPD referrals services discussed during clinical training were also included to promote ease of care coordination and awareness of referral opportunities. The integration of clinical training with informatics note template support was intentional to directly relate clinical training to clinical care delivery.

Audit and Feedback

To inform COPD CARE practice, the Academy included informatics infrastructure that allowed for timely local quality monitoring. Electronic health record note templates with embedded data fields track COPD CARE service implementation, including timely completion of patient visits, completion of patient medication reviews, appropriate testing, symptom assessment, and interventions made. Champions can organize template installation and integrate templates into COPD CARE clinical training. Data are included on a COPD CARE implementation dashboard.

An audit and feedback process is allows for the review of performance metrics and development of action plans.20,21 Data reports from note templates are described during the Academy, along with resources to help teams enhance delivery of their program based on performance metrics.

Building a Coalition

Within VA primary care, clinical care delivery is optimized through a team-based coalition of clinicians using the patient aligned care team (PACT) framework. The VA patient-centered team-based care delivery model, patient facilitates coordination of patient referrals, including patient review, scheduling, and completion of patient visits.22

Partnerships with VA Pharmacy Benefits Manager, VA Diffusion of Excellence, VA Quality Enhancement Research Initiative, VA Office of Pulmonary Medicine, and the VA Office of Rural Health have facilitated COPD CARE successes. Collaborations with VA Centers of Innovation helped benchmark the Academy’s impact. An academic partnership with the University of Wisconsin-Madison was established in 2017 and has provided evaluation expertise and leadership as the Academy has been iteratively developed, and revised.

Preliminary Metrics

COPD CARE has delivered > 2000 visits. CPPs have delivered COPD care, with a mean 9.4 of 10 best practices per patient visit. Improvements in veteran COPD symptoms have also been observed following COPD CARE patient visits.

DISCUSSION

The COPD CARE Academy was developed to promote rapid scale-up of a complex, team-based COPD service delivered during veteran care transitions. The implementation blueprint for the Academy is multifaceted and integrates both clinical-focused and implementation-focused infrastructure to apply training content.23 A randomized control trial evaluating the efficacy of training modalities found a need to expand implementation blueprints beyond clinical training alone, as training by itself may not be sufficient to change behavior.24 VA staff designed the Academy using clinical- and implementation-focused content within its implementation blueprint. Key components included leveraging clinical champions, using a train-the-trainer approach, and incorporating facilitation strategies to overcome adoption barriers.

Lewis et al emphasize matching implementation strategies to barriers within VA staff who identify care coordination as a key challenge.23 The informatics infrastructure developed for Academy learners, including standardized note templates, video modeling examples of clinic visits, and data capture for audit and feedback, was designed to complement clinical training and standardize service workflows (Figure 2). There are opportunities to explore how to optimize technology in the Academy.

0825Fed-COPD-F2

While Academy clinical training specifically focuses on COPD management, many implementation strategies can be considered to promote care delivery services for other chronic conditions. The Academy blueprint and implementation infrastructure, are strategies that may be considered within and outside the federal health care system. The opportunity for adaptations to Academy training enables clinical champions to promote tailored content to the needs of each unique VAMC. The translation of Academy implementation strategies for new chronic conditions will similarly require adaptations at each VAMC to promote adoption of content.

CONCLUSIONS

COPD CARE Academy is an example of the collaborative spirit within VA, and the opportunity for further advancement of health care programs. The VA is a national leader in Learning Health Systems implementation, in which “science, informatics, incentives and culture are aligned for continuous improvement and innovation.”25,26 There are many opportunities for VA staff to learn from one another to form partnerships between leaders, clinicians, and scientists to optimize health care delivery and further the VA’s work as a learning health system.

References
  1. Robinson CH, Thompto AJ, Lima EN, Damschroder LJ. Continuous quality improvement at the frontline: one interdisciplinary clinical team's four-year journey after completing a virtual learning program. Learn Health Syst. 2022;6(4):e10345. doi:10.1002/lrh2.10345
  2. US Department of Veterans Affairs. Continuous quality improvement (CQI) for clinical teams: a systematic review of reviews. Accessed July 24, 2025. https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID=4151
  3. Dondanville KA, Fina BA, Straud CL, et al. Launching a competency-based training program in evidence-based treatments for PTSD: supporting veteran-serving mental health providers in Texas. Community Ment Health J. 2021;57(5):910-919. doi:10.1007/S10597-020-00676-7
  4. Abildso CG, Zizzi SJ, Reger-Nash B. Evaluating an insurance- sponsored weight management program with the RE-AIM model, West Virginia, 2004-2008. Prev Chronic Dis. 2010;7(3):A46.
  5. Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National institutes of health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012;102(7):1274- 1281. doi:10.2105/AJPH.2012.300755
  6. Portillo EC, Maurer MA, Kettner JT, et al. Applying RE-AIM to examine the impact of an implementation facilitation package to scale up a program for veterans with chronic obstructive pulmonary disease. Implement Sci Commun. 2023;4(1):143. doi:10.1186/S43058-023-00520-5
  7. McGhan R, Radcliff T, Fish R, Sutherland ER, Welsh C, Make B. Predictors of rehospitalization and death after a severe exacerbation of COPD. Chest. 2007;132(6):1748- 1755. doi:10.1378/chest.06-3018
  8. Anderson E, Wiener RS, Resnick K, Elwy AR, Rinne ST. Care coordination for veterans with COPD: a positive deviance study. Am J Manag Care. 2020;26(2):63-68. doi:10.37765/AJMC.2020.42394
  9. 2024 GOLD Report. Global Initiative for Chronic Obstructive Lung Disease - GOLD. Accessed July 24, 2025. https://goldcopd.org/2024-gold-report/
  10. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-e69. doi:10.1164/rccm.202003-0625ST
  11. Portillo EC, Wilcox A, Seckel E, et al. Reducing COPD readmission rates: using a COPD care service during care transitions. Fed Pract. 2018;35(11):30-36.
  12. Portillo EC, Gruber S, Lehmann M, et al. Application of the replicating effective programs framework to design a COPD training program. J Am Pharm Assoc. 2021;61(2):e129-e135. doi:10.1016/J.JAPH.2020.10.023
  13. Portillo EC, Lehmann MR, Hagen TL, et al. Integration of the patient-centered medical home to deliver a care bundle for chronic obstructive pulmonary disease management. J Am Pharm Assoc. 2023;63(1):212-219. doi:10.1016/j.japh.2022.10.003
  14. Portillo E, Lehmann M, Hagen T, et al. Evaluation of an implementation package to deliver the COPD CARE service. BMJ Open Qual. 2023;12(1). doi:10.1136/BMJOQ-2022-002074
  15. Portillo E, Lehmann M, Maurer M, et al. Barriers to implementing a pharmacist-led COPD care bundle in rural settings: A qualitative evaluation. 2025 (under review).
  16. Population Health Management. American Hospital Association. Accessed July 24, 2025. https://www.aha.org/center/population-health-management
  17. Ritchie MJ, Dollar KM, Miller CK, et al. Using implementation facilitation to improve healthcare: implementation facilitation training manual. Accessed July 11, 2024. https:// www.queri.research.va.gov/tools/Facilitation-Manual.pdf
  18. Morena AL, Gaias LM, Larkin C. Understanding the role of clinical champions and their impact on clinician behavior change: the need for causal pathway mechanisms. Front Health Serv. 2022;2:896885. doi:10.3389/FRHS.2022.896885
  19. Ayele RA, Rabin BA, McCreight M, Battaglia C. Editorial: understanding, assessing, and guiding adaptations in public health and health systems interventions: current and future directions. Front Public Health. 2023;11:1228437. doi:10.3389/fpubh.2023.1228437
  20. Jamtvedt G, Flottorp S, Ivers N. Audit and feedback as a quality strategy. In: Improving Healthcare Services. World Health Organization; 2019. Accessed July 24, 2025. https://www.ncbi.nlm.nih.gov/books/NBK549284/
  21. Snider MDH, Boyd MR, Walker MR, Powell BJ, Lewis CC. Using audit and feedback to guide tailored implementations of measurement-based care in community mental health: a multiple case study. Implement Sci Commun. 2023;4(1):94. doi:10.1186/s43058-023-00474-8
  22. Patient Aligned Care Team (PACT) – Patient Care Services. US Department of Veterans Affairs. Accessed July 24, 2025. https://www.patientcare.va.gov/primarycare/PACT.asp
  23. Lewis CC, Scott K, Marriott BR. A methodology for generating a tailored implementation blueprint: an exemplar from a youth residential setting. Implementat Sci. 2018;13(1):68. doi:10.1186/s13012-018-0761-6
  24. Beidas RS, Edmunds JM, Marcus SC, Kendall PC. Training and consultation to promote implementation of an empirically supported treatment: a randomized trial. Psychiatr Serv. 2012;63(7):660-665. doi:10.1176/appi.ps.201100401
  25. Kilbourne AM, Schmidt J, Edmunds M, Vega R, Bowersox N, Atkins D. How the VA is training the next-generation workforce for learning health systems. Learn Health Syst. 2022;6(4):e10333. doi:10.1002/LRH2.10333
  26. Easterling D, Perry AC, Woodside R, Patel T, Gesell SB. Clarifying the concept of a learning health system for healthcare delivery organizations: implications from a qualitative analysis of the scientific literature. Learn Health Syst. 2021;6(2):e10287. doi:10.1002/LRH2.10287
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Edward C. Portillo, PharmDa; Steven Dob; Tiffany M. Parham, MAa; Jordyn Kettner, PharmDb; Nora Jacobson, PhDb; Jenna Vande Heyb; Dylan Erdeltb; Martha Maurer, PhD, MPH, MSSWb; Tim Hagen, MBAc; Molly Lehmann, PharmD, BCPSa; Sarah Will, PharmD, BCPSd; Heather Ourth, PharmD, BCPS, BCGPd; Michelle Chui, PharmD, PhDb; M. Shawn McFarland, PharmD, BCACPd

Author affiliations
aWilliams S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
bUniversity of Wisconsin, Madison School of Pharmacy
cVeterans Affairs Healthcare System of the Ozarks, Fayetteville, Arkansas
dUS Department of Veterans Affairs Clinical Pharmacy Practice Office, Washington, DC

Author disclosures
The authors report no actual or potential conflicts of interests with regards to the article.

Correspondence: Edward Portillo ([email protected])

Fed Pract. 2025;42(8):e0613. Published online August 15. doi:10.12788/fp.0613

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Edward C. Portillo, PharmDa; Steven Dob; Tiffany M. Parham, MAa; Jordyn Kettner, PharmDb; Nora Jacobson, PhDb; Jenna Vande Heyb; Dylan Erdeltb; Martha Maurer, PhD, MPH, MSSWb; Tim Hagen, MBAc; Molly Lehmann, PharmD, BCPSa; Sarah Will, PharmD, BCPSd; Heather Ourth, PharmD, BCPS, BCGPd; Michelle Chui, PharmD, PhDb; M. Shawn McFarland, PharmD, BCACPd

Author affiliations
aWilliams S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
bUniversity of Wisconsin, Madison School of Pharmacy
cVeterans Affairs Healthcare System of the Ozarks, Fayetteville, Arkansas
dUS Department of Veterans Affairs Clinical Pharmacy Practice Office, Washington, DC

Author disclosures
The authors report no actual or potential conflicts of interests with regards to the article.

Correspondence: Edward Portillo ([email protected])

Fed Pract. 2025;42(8):e0613. Published online August 15. doi:10.12788/fp.0613

Author and Disclosure Information

Edward C. Portillo, PharmDa; Steven Dob; Tiffany M. Parham, MAa; Jordyn Kettner, PharmDb; Nora Jacobson, PhDb; Jenna Vande Heyb; Dylan Erdeltb; Martha Maurer, PhD, MPH, MSSWb; Tim Hagen, MBAc; Molly Lehmann, PharmD, BCPSa; Sarah Will, PharmD, BCPSd; Heather Ourth, PharmD, BCPS, BCGPd; Michelle Chui, PharmD, PhDb; M. Shawn McFarland, PharmD, BCACPd

Author affiliations
aWilliams S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
bUniversity of Wisconsin, Madison School of Pharmacy
cVeterans Affairs Healthcare System of the Ozarks, Fayetteville, Arkansas
dUS Department of Veterans Affairs Clinical Pharmacy Practice Office, Washington, DC

Author disclosures
The authors report no actual or potential conflicts of interests with regards to the article.

Correspondence: Edward Portillo ([email protected])

Fed Pract. 2025;42(8):e0613. Published online August 15. doi:10.12788/fp.0613

Article PDF
Article PDF

Quality improvement (QI) initiatives within the US Department of Veterans Affairs (VA) play an important role in enhancing health care for veterans.1,2 While effective QI programs are often developed, veterans benefit only if they receive care at sites where the program is offered.3 It is estimated only 1% to 5% of patients receive benefit from evidence-based programs, limiting the opportunity for widespread impact.4,5

The Chronic Obstructive Pulmonary Disease (COPD) Coordinated Access to Reduce Exacerbations (CARE) Academy is a national training program designed to promote the adoption of a COPD primary care service.6 The Academy was created and iteratively refined by VA staff to include both clinical training emphasizing COPD management and program implementation strategies. Training programs such as COPD CARE are commonly described as a method to support adoption of health care services, but there is no consensus on a universal approach to training design.

This article describes COPD CARE training and implementation strategies (Table). The Academy began as a training program at 1 VA medical center (VAMC) and has expanded to 49 diverse VAMCs. The Academy illustrates how implementation strategies can be leveraged to develop pragmatic and impactful training. Highlights from the Academy's 9-year history are outlined in this article.

0825Fed-COPD-T1

COPD CARE

One in 4 veterans have a COPD diagnosis, and the 5-year mortality rate following a COPD flare is ≥ 50%.7,8 In 2015, a pharmacy resident designed and piloted COPD CARE, a program that used evidence-based practice to optimize management of the disease.9,10

The COPD CARE program is delivered by interprofessional team members. It includes a postacute care call completed 48 hours postdischarge, a wellness visit (face-to-face or virtual) 1 month postdischarge, and a follow-up visit scheduled 2 months postdischarge. Clinical pharmacist practitioners (CPPs) prescribe and collaborate with the COPD CARE health care team. Evidence-based practices embedded within COPD CARE include treatment optimization, symptom evaluation, severity staging, vaccination promotion, referrals, tobacco treatment, and comorbidity management.11-16 The initial COPD CARE pilot demonstrated promising results; patients received timely care and high rates of COPD best practices.11

Academy Design and Implementation

Initial COPD CARE training was tailored to the culture, context, and workflow of the William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin. Further service expansion required integration of implementation strategies that enable learners to apply and adapt content to fit different processes, staffing, and patient needs.

Formal Implementation Blueprint

A key aspect of the Academy is the integration of a formal implementation blueprint that includes training goals, scope, and key milestones to guide implementation. The Academy blueprint includes 4 phased training workbooks: (1) preimplementation support from local stakeholders; (2) integration of COPD CARE operational infrastructure into workflows; (3) preparing clinical champions; and (4) leading clinical training (Figure 1). Five weekly 1-hour synchronous virtual discussions are used for learning the workbook content that include learning objectives and opportunities to strategize how to overcome implementation barriers.

0825Fed-COPD-F1
Promoting and Facilitating Implementation

As clinicians apply content from the Academy to install informatics tools, coordinate clinical training, and build relationships across service lines, implementation barriers may occur. A learning collaborative allows peer-mentorship and shared problem solving. The Academy learning collaborative includes attendees across multiple VAMCs, allowing for diverse perspectives and cross-site learning. Within the field of dissemination and implementation science, this process of shared problem-solving to support individuals is referred to as implementation facilitation.17 Academy facilitators with prior experience provide a unique perspective and external facilitation from outside local VAMCs. Academy learners form local teams to engage in shared decision-making when applying Academy content. Following Academy completion, learning collaboratives continue to meet monthly to share clinical insights and operational updates.

Local Champions Promote Adaptability

One or more local champions were identified at each VAMC who were focused on the implementation of clinical training content and operational implementation of Academy content.18 Champions have helped develop adaptations of Academy content, such as integrating telehealth nursing within the COPD CARE referral process, which have become new best practices. Champions attend Academy sessions, which provide an opportunity to share adaptations to meet local needs.19

Using a Train-The-Trainer Model

Clinical training was designed to be dynamic and included video modeling, such as recorded examples of CPPs conducting COPD CARE visits and video clips highlighting clinical content. Each learner received a clinical workbook summarizing the content. The champion shares discussion questions to relate training content to the local clinical practice setting. The combination of live training, with videos of clinic visits and case-based discussion was intended to address differing learning styles. Clinical training was delivered using a train-the-trainer model led by the local champion, which allows clinicians with expertise to tailor their training. The use of a train-the-trainer model was intended to promote local buy-in and was often completed by frontline clinicians.

Informatics note templates provide clinicians with information needed to deliver training content during clinic visits. Direct hyperlinks to symptomatic scoring tools, resources to promote evidence-based medication optimization, and patient education resources were embedded within the electronic health record note templates. Direct links to consults for COPD referrals services discussed during clinical training were also included to promote ease of care coordination and awareness of referral opportunities. The integration of clinical training with informatics note template support was intentional to directly relate clinical training to clinical care delivery.

Audit and Feedback

To inform COPD CARE practice, the Academy included informatics infrastructure that allowed for timely local quality monitoring. Electronic health record note templates with embedded data fields track COPD CARE service implementation, including timely completion of patient visits, completion of patient medication reviews, appropriate testing, symptom assessment, and interventions made. Champions can organize template installation and integrate templates into COPD CARE clinical training. Data are included on a COPD CARE implementation dashboard.

An audit and feedback process is allows for the review of performance metrics and development of action plans.20,21 Data reports from note templates are described during the Academy, along with resources to help teams enhance delivery of their program based on performance metrics.

Building a Coalition

Within VA primary care, clinical care delivery is optimized through a team-based coalition of clinicians using the patient aligned care team (PACT) framework. The VA patient-centered team-based care delivery model, patient facilitates coordination of patient referrals, including patient review, scheduling, and completion of patient visits.22

Partnerships with VA Pharmacy Benefits Manager, VA Diffusion of Excellence, VA Quality Enhancement Research Initiative, VA Office of Pulmonary Medicine, and the VA Office of Rural Health have facilitated COPD CARE successes. Collaborations with VA Centers of Innovation helped benchmark the Academy’s impact. An academic partnership with the University of Wisconsin-Madison was established in 2017 and has provided evaluation expertise and leadership as the Academy has been iteratively developed, and revised.

Preliminary Metrics

COPD CARE has delivered > 2000 visits. CPPs have delivered COPD care, with a mean 9.4 of 10 best practices per patient visit. Improvements in veteran COPD symptoms have also been observed following COPD CARE patient visits.

DISCUSSION

The COPD CARE Academy was developed to promote rapid scale-up of a complex, team-based COPD service delivered during veteran care transitions. The implementation blueprint for the Academy is multifaceted and integrates both clinical-focused and implementation-focused infrastructure to apply training content.23 A randomized control trial evaluating the efficacy of training modalities found a need to expand implementation blueprints beyond clinical training alone, as training by itself may not be sufficient to change behavior.24 VA staff designed the Academy using clinical- and implementation-focused content within its implementation blueprint. Key components included leveraging clinical champions, using a train-the-trainer approach, and incorporating facilitation strategies to overcome adoption barriers.

Lewis et al emphasize matching implementation strategies to barriers within VA staff who identify care coordination as a key challenge.23 The informatics infrastructure developed for Academy learners, including standardized note templates, video modeling examples of clinic visits, and data capture for audit and feedback, was designed to complement clinical training and standardize service workflows (Figure 2). There are opportunities to explore how to optimize technology in the Academy.

0825Fed-COPD-F2

While Academy clinical training specifically focuses on COPD management, many implementation strategies can be considered to promote care delivery services for other chronic conditions. The Academy blueprint and implementation infrastructure, are strategies that may be considered within and outside the federal health care system. The opportunity for adaptations to Academy training enables clinical champions to promote tailored content to the needs of each unique VAMC. The translation of Academy implementation strategies for new chronic conditions will similarly require adaptations at each VAMC to promote adoption of content.

CONCLUSIONS

COPD CARE Academy is an example of the collaborative spirit within VA, and the opportunity for further advancement of health care programs. The VA is a national leader in Learning Health Systems implementation, in which “science, informatics, incentives and culture are aligned for continuous improvement and innovation.”25,26 There are many opportunities for VA staff to learn from one another to form partnerships between leaders, clinicians, and scientists to optimize health care delivery and further the VA’s work as a learning health system.

Quality improvement (QI) initiatives within the US Department of Veterans Affairs (VA) play an important role in enhancing health care for veterans.1,2 While effective QI programs are often developed, veterans benefit only if they receive care at sites where the program is offered.3 It is estimated only 1% to 5% of patients receive benefit from evidence-based programs, limiting the opportunity for widespread impact.4,5

The Chronic Obstructive Pulmonary Disease (COPD) Coordinated Access to Reduce Exacerbations (CARE) Academy is a national training program designed to promote the adoption of a COPD primary care service.6 The Academy was created and iteratively refined by VA staff to include both clinical training emphasizing COPD management and program implementation strategies. Training programs such as COPD CARE are commonly described as a method to support adoption of health care services, but there is no consensus on a universal approach to training design.

This article describes COPD CARE training and implementation strategies (Table). The Academy began as a training program at 1 VA medical center (VAMC) and has expanded to 49 diverse VAMCs. The Academy illustrates how implementation strategies can be leveraged to develop pragmatic and impactful training. Highlights from the Academy's 9-year history are outlined in this article.

0825Fed-COPD-T1

COPD CARE

One in 4 veterans have a COPD diagnosis, and the 5-year mortality rate following a COPD flare is ≥ 50%.7,8 In 2015, a pharmacy resident designed and piloted COPD CARE, a program that used evidence-based practice to optimize management of the disease.9,10

The COPD CARE program is delivered by interprofessional team members. It includes a postacute care call completed 48 hours postdischarge, a wellness visit (face-to-face or virtual) 1 month postdischarge, and a follow-up visit scheduled 2 months postdischarge. Clinical pharmacist practitioners (CPPs) prescribe and collaborate with the COPD CARE health care team. Evidence-based practices embedded within COPD CARE include treatment optimization, symptom evaluation, severity staging, vaccination promotion, referrals, tobacco treatment, and comorbidity management.11-16 The initial COPD CARE pilot demonstrated promising results; patients received timely care and high rates of COPD best practices.11

Academy Design and Implementation

Initial COPD CARE training was tailored to the culture, context, and workflow of the William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin. Further service expansion required integration of implementation strategies that enable learners to apply and adapt content to fit different processes, staffing, and patient needs.

Formal Implementation Blueprint

A key aspect of the Academy is the integration of a formal implementation blueprint that includes training goals, scope, and key milestones to guide implementation. The Academy blueprint includes 4 phased training workbooks: (1) preimplementation support from local stakeholders; (2) integration of COPD CARE operational infrastructure into workflows; (3) preparing clinical champions; and (4) leading clinical training (Figure 1). Five weekly 1-hour synchronous virtual discussions are used for learning the workbook content that include learning objectives and opportunities to strategize how to overcome implementation barriers.

0825Fed-COPD-F1
Promoting and Facilitating Implementation

As clinicians apply content from the Academy to install informatics tools, coordinate clinical training, and build relationships across service lines, implementation barriers may occur. A learning collaborative allows peer-mentorship and shared problem solving. The Academy learning collaborative includes attendees across multiple VAMCs, allowing for diverse perspectives and cross-site learning. Within the field of dissemination and implementation science, this process of shared problem-solving to support individuals is referred to as implementation facilitation.17 Academy facilitators with prior experience provide a unique perspective and external facilitation from outside local VAMCs. Academy learners form local teams to engage in shared decision-making when applying Academy content. Following Academy completion, learning collaboratives continue to meet monthly to share clinical insights and operational updates.

Local Champions Promote Adaptability

One or more local champions were identified at each VAMC who were focused on the implementation of clinical training content and operational implementation of Academy content.18 Champions have helped develop adaptations of Academy content, such as integrating telehealth nursing within the COPD CARE referral process, which have become new best practices. Champions attend Academy sessions, which provide an opportunity to share adaptations to meet local needs.19

Using a Train-The-Trainer Model

Clinical training was designed to be dynamic and included video modeling, such as recorded examples of CPPs conducting COPD CARE visits and video clips highlighting clinical content. Each learner received a clinical workbook summarizing the content. The champion shares discussion questions to relate training content to the local clinical practice setting. The combination of live training, with videos of clinic visits and case-based discussion was intended to address differing learning styles. Clinical training was delivered using a train-the-trainer model led by the local champion, which allows clinicians with expertise to tailor their training. The use of a train-the-trainer model was intended to promote local buy-in and was often completed by frontline clinicians.

Informatics note templates provide clinicians with information needed to deliver training content during clinic visits. Direct hyperlinks to symptomatic scoring tools, resources to promote evidence-based medication optimization, and patient education resources were embedded within the electronic health record note templates. Direct links to consults for COPD referrals services discussed during clinical training were also included to promote ease of care coordination and awareness of referral opportunities. The integration of clinical training with informatics note template support was intentional to directly relate clinical training to clinical care delivery.

Audit and Feedback

To inform COPD CARE practice, the Academy included informatics infrastructure that allowed for timely local quality monitoring. Electronic health record note templates with embedded data fields track COPD CARE service implementation, including timely completion of patient visits, completion of patient medication reviews, appropriate testing, symptom assessment, and interventions made. Champions can organize template installation and integrate templates into COPD CARE clinical training. Data are included on a COPD CARE implementation dashboard.

An audit and feedback process is allows for the review of performance metrics and development of action plans.20,21 Data reports from note templates are described during the Academy, along with resources to help teams enhance delivery of their program based on performance metrics.

Building a Coalition

Within VA primary care, clinical care delivery is optimized through a team-based coalition of clinicians using the patient aligned care team (PACT) framework. The VA patient-centered team-based care delivery model, patient facilitates coordination of patient referrals, including patient review, scheduling, and completion of patient visits.22

Partnerships with VA Pharmacy Benefits Manager, VA Diffusion of Excellence, VA Quality Enhancement Research Initiative, VA Office of Pulmonary Medicine, and the VA Office of Rural Health have facilitated COPD CARE successes. Collaborations with VA Centers of Innovation helped benchmark the Academy’s impact. An academic partnership with the University of Wisconsin-Madison was established in 2017 and has provided evaluation expertise and leadership as the Academy has been iteratively developed, and revised.

Preliminary Metrics

COPD CARE has delivered > 2000 visits. CPPs have delivered COPD care, with a mean 9.4 of 10 best practices per patient visit. Improvements in veteran COPD symptoms have also been observed following COPD CARE patient visits.

DISCUSSION

The COPD CARE Academy was developed to promote rapid scale-up of a complex, team-based COPD service delivered during veteran care transitions. The implementation blueprint for the Academy is multifaceted and integrates both clinical-focused and implementation-focused infrastructure to apply training content.23 A randomized control trial evaluating the efficacy of training modalities found a need to expand implementation blueprints beyond clinical training alone, as training by itself may not be sufficient to change behavior.24 VA staff designed the Academy using clinical- and implementation-focused content within its implementation blueprint. Key components included leveraging clinical champions, using a train-the-trainer approach, and incorporating facilitation strategies to overcome adoption barriers.

Lewis et al emphasize matching implementation strategies to barriers within VA staff who identify care coordination as a key challenge.23 The informatics infrastructure developed for Academy learners, including standardized note templates, video modeling examples of clinic visits, and data capture for audit and feedback, was designed to complement clinical training and standardize service workflows (Figure 2). There are opportunities to explore how to optimize technology in the Academy.

0825Fed-COPD-F2

While Academy clinical training specifically focuses on COPD management, many implementation strategies can be considered to promote care delivery services for other chronic conditions. The Academy blueprint and implementation infrastructure, are strategies that may be considered within and outside the federal health care system. The opportunity for adaptations to Academy training enables clinical champions to promote tailored content to the needs of each unique VAMC. The translation of Academy implementation strategies for new chronic conditions will similarly require adaptations at each VAMC to promote adoption of content.

CONCLUSIONS

COPD CARE Academy is an example of the collaborative spirit within VA, and the opportunity for further advancement of health care programs. The VA is a national leader in Learning Health Systems implementation, in which “science, informatics, incentives and culture are aligned for continuous improvement and innovation.”25,26 There are many opportunities for VA staff to learn from one another to form partnerships between leaders, clinicians, and scientists to optimize health care delivery and further the VA’s work as a learning health system.

References
  1. Robinson CH, Thompto AJ, Lima EN, Damschroder LJ. Continuous quality improvement at the frontline: one interdisciplinary clinical team's four-year journey after completing a virtual learning program. Learn Health Syst. 2022;6(4):e10345. doi:10.1002/lrh2.10345
  2. US Department of Veterans Affairs. Continuous quality improvement (CQI) for clinical teams: a systematic review of reviews. Accessed July 24, 2025. https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID=4151
  3. Dondanville KA, Fina BA, Straud CL, et al. Launching a competency-based training program in evidence-based treatments for PTSD: supporting veteran-serving mental health providers in Texas. Community Ment Health J. 2021;57(5):910-919. doi:10.1007/S10597-020-00676-7
  4. Abildso CG, Zizzi SJ, Reger-Nash B. Evaluating an insurance- sponsored weight management program with the RE-AIM model, West Virginia, 2004-2008. Prev Chronic Dis. 2010;7(3):A46.
  5. Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National institutes of health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012;102(7):1274- 1281. doi:10.2105/AJPH.2012.300755
  6. Portillo EC, Maurer MA, Kettner JT, et al. Applying RE-AIM to examine the impact of an implementation facilitation package to scale up a program for veterans with chronic obstructive pulmonary disease. Implement Sci Commun. 2023;4(1):143. doi:10.1186/S43058-023-00520-5
  7. McGhan R, Radcliff T, Fish R, Sutherland ER, Welsh C, Make B. Predictors of rehospitalization and death after a severe exacerbation of COPD. Chest. 2007;132(6):1748- 1755. doi:10.1378/chest.06-3018
  8. Anderson E, Wiener RS, Resnick K, Elwy AR, Rinne ST. Care coordination for veterans with COPD: a positive deviance study. Am J Manag Care. 2020;26(2):63-68. doi:10.37765/AJMC.2020.42394
  9. 2024 GOLD Report. Global Initiative for Chronic Obstructive Lung Disease - GOLD. Accessed July 24, 2025. https://goldcopd.org/2024-gold-report/
  10. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-e69. doi:10.1164/rccm.202003-0625ST
  11. Portillo EC, Wilcox A, Seckel E, et al. Reducing COPD readmission rates: using a COPD care service during care transitions. Fed Pract. 2018;35(11):30-36.
  12. Portillo EC, Gruber S, Lehmann M, et al. Application of the replicating effective programs framework to design a COPD training program. J Am Pharm Assoc. 2021;61(2):e129-e135. doi:10.1016/J.JAPH.2020.10.023
  13. Portillo EC, Lehmann MR, Hagen TL, et al. Integration of the patient-centered medical home to deliver a care bundle for chronic obstructive pulmonary disease management. J Am Pharm Assoc. 2023;63(1):212-219. doi:10.1016/j.japh.2022.10.003
  14. Portillo E, Lehmann M, Hagen T, et al. Evaluation of an implementation package to deliver the COPD CARE service. BMJ Open Qual. 2023;12(1). doi:10.1136/BMJOQ-2022-002074
  15. Portillo E, Lehmann M, Maurer M, et al. Barriers to implementing a pharmacist-led COPD care bundle in rural settings: A qualitative evaluation. 2025 (under review).
  16. Population Health Management. American Hospital Association. Accessed July 24, 2025. https://www.aha.org/center/population-health-management
  17. Ritchie MJ, Dollar KM, Miller CK, et al. Using implementation facilitation to improve healthcare: implementation facilitation training manual. Accessed July 11, 2024. https:// www.queri.research.va.gov/tools/Facilitation-Manual.pdf
  18. Morena AL, Gaias LM, Larkin C. Understanding the role of clinical champions and their impact on clinician behavior change: the need for causal pathway mechanisms. Front Health Serv. 2022;2:896885. doi:10.3389/FRHS.2022.896885
  19. Ayele RA, Rabin BA, McCreight M, Battaglia C. Editorial: understanding, assessing, and guiding adaptations in public health and health systems interventions: current and future directions. Front Public Health. 2023;11:1228437. doi:10.3389/fpubh.2023.1228437
  20. Jamtvedt G, Flottorp S, Ivers N. Audit and feedback as a quality strategy. In: Improving Healthcare Services. World Health Organization; 2019. Accessed July 24, 2025. https://www.ncbi.nlm.nih.gov/books/NBK549284/
  21. Snider MDH, Boyd MR, Walker MR, Powell BJ, Lewis CC. Using audit and feedback to guide tailored implementations of measurement-based care in community mental health: a multiple case study. Implement Sci Commun. 2023;4(1):94. doi:10.1186/s43058-023-00474-8
  22. Patient Aligned Care Team (PACT) – Patient Care Services. US Department of Veterans Affairs. Accessed July 24, 2025. https://www.patientcare.va.gov/primarycare/PACT.asp
  23. Lewis CC, Scott K, Marriott BR. A methodology for generating a tailored implementation blueprint: an exemplar from a youth residential setting. Implementat Sci. 2018;13(1):68. doi:10.1186/s13012-018-0761-6
  24. Beidas RS, Edmunds JM, Marcus SC, Kendall PC. Training and consultation to promote implementation of an empirically supported treatment: a randomized trial. Psychiatr Serv. 2012;63(7):660-665. doi:10.1176/appi.ps.201100401
  25. Kilbourne AM, Schmidt J, Edmunds M, Vega R, Bowersox N, Atkins D. How the VA is training the next-generation workforce for learning health systems. Learn Health Syst. 2022;6(4):e10333. doi:10.1002/LRH2.10333
  26. Easterling D, Perry AC, Woodside R, Patel T, Gesell SB. Clarifying the concept of a learning health system for healthcare delivery organizations: implications from a qualitative analysis of the scientific literature. Learn Health Syst. 2021;6(2):e10287. doi:10.1002/LRH2.10287
References
  1. Robinson CH, Thompto AJ, Lima EN, Damschroder LJ. Continuous quality improvement at the frontline: one interdisciplinary clinical team's four-year journey after completing a virtual learning program. Learn Health Syst. 2022;6(4):e10345. doi:10.1002/lrh2.10345
  2. US Department of Veterans Affairs. Continuous quality improvement (CQI) for clinical teams: a systematic review of reviews. Accessed July 24, 2025. https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID=4151
  3. Dondanville KA, Fina BA, Straud CL, et al. Launching a competency-based training program in evidence-based treatments for PTSD: supporting veteran-serving mental health providers in Texas. Community Ment Health J. 2021;57(5):910-919. doi:10.1007/S10597-020-00676-7
  4. Abildso CG, Zizzi SJ, Reger-Nash B. Evaluating an insurance- sponsored weight management program with the RE-AIM model, West Virginia, 2004-2008. Prev Chronic Dis. 2010;7(3):A46.
  5. Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National institutes of health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012;102(7):1274- 1281. doi:10.2105/AJPH.2012.300755
  6. Portillo EC, Maurer MA, Kettner JT, et al. Applying RE-AIM to examine the impact of an implementation facilitation package to scale up a program for veterans with chronic obstructive pulmonary disease. Implement Sci Commun. 2023;4(1):143. doi:10.1186/S43058-023-00520-5
  7. McGhan R, Radcliff T, Fish R, Sutherland ER, Welsh C, Make B. Predictors of rehospitalization and death after a severe exacerbation of COPD. Chest. 2007;132(6):1748- 1755. doi:10.1378/chest.06-3018
  8. Anderson E, Wiener RS, Resnick K, Elwy AR, Rinne ST. Care coordination for veterans with COPD: a positive deviance study. Am J Manag Care. 2020;26(2):63-68. doi:10.37765/AJMC.2020.42394
  9. 2024 GOLD Report. Global Initiative for Chronic Obstructive Lung Disease - GOLD. Accessed July 24, 2025. https://goldcopd.org/2024-gold-report/
  10. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-e69. doi:10.1164/rccm.202003-0625ST
  11. Portillo EC, Wilcox A, Seckel E, et al. Reducing COPD readmission rates: using a COPD care service during care transitions. Fed Pract. 2018;35(11):30-36.
  12. Portillo EC, Gruber S, Lehmann M, et al. Application of the replicating effective programs framework to design a COPD training program. J Am Pharm Assoc. 2021;61(2):e129-e135. doi:10.1016/J.JAPH.2020.10.023
  13. Portillo EC, Lehmann MR, Hagen TL, et al. Integration of the patient-centered medical home to deliver a care bundle for chronic obstructive pulmonary disease management. J Am Pharm Assoc. 2023;63(1):212-219. doi:10.1016/j.japh.2022.10.003
  14. Portillo E, Lehmann M, Hagen T, et al. Evaluation of an implementation package to deliver the COPD CARE service. BMJ Open Qual. 2023;12(1). doi:10.1136/BMJOQ-2022-002074
  15. Portillo E, Lehmann M, Maurer M, et al. Barriers to implementing a pharmacist-led COPD care bundle in rural settings: A qualitative evaluation. 2025 (under review).
  16. Population Health Management. American Hospital Association. Accessed July 24, 2025. https://www.aha.org/center/population-health-management
  17. Ritchie MJ, Dollar KM, Miller CK, et al. Using implementation facilitation to improve healthcare: implementation facilitation training manual. Accessed July 11, 2024. https:// www.queri.research.va.gov/tools/Facilitation-Manual.pdf
  18. Morena AL, Gaias LM, Larkin C. Understanding the role of clinical champions and their impact on clinician behavior change: the need for causal pathway mechanisms. Front Health Serv. 2022;2:896885. doi:10.3389/FRHS.2022.896885
  19. Ayele RA, Rabin BA, McCreight M, Battaglia C. Editorial: understanding, assessing, and guiding adaptations in public health and health systems interventions: current and future directions. Front Public Health. 2023;11:1228437. doi:10.3389/fpubh.2023.1228437
  20. Jamtvedt G, Flottorp S, Ivers N. Audit and feedback as a quality strategy. In: Improving Healthcare Services. World Health Organization; 2019. Accessed July 24, 2025. https://www.ncbi.nlm.nih.gov/books/NBK549284/
  21. Snider MDH, Boyd MR, Walker MR, Powell BJ, Lewis CC. Using audit and feedback to guide tailored implementations of measurement-based care in community mental health: a multiple case study. Implement Sci Commun. 2023;4(1):94. doi:10.1186/s43058-023-00474-8
  22. Patient Aligned Care Team (PACT) – Patient Care Services. US Department of Veterans Affairs. Accessed July 24, 2025. https://www.patientcare.va.gov/primarycare/PACT.asp
  23. Lewis CC, Scott K, Marriott BR. A methodology for generating a tailored implementation blueprint: an exemplar from a youth residential setting. Implementat Sci. 2018;13(1):68. doi:10.1186/s13012-018-0761-6
  24. Beidas RS, Edmunds JM, Marcus SC, Kendall PC. Training and consultation to promote implementation of an empirically supported treatment: a randomized trial. Psychiatr Serv. 2012;63(7):660-665. doi:10.1176/appi.ps.201100401
  25. Kilbourne AM, Schmidt J, Edmunds M, Vega R, Bowersox N, Atkins D. How the VA is training the next-generation workforce for learning health systems. Learn Health Syst. 2022;6(4):e10333. doi:10.1002/LRH2.10333
  26. Easterling D, Perry AC, Woodside R, Patel T, Gesell SB. Clarifying the concept of a learning health system for healthcare delivery organizations: implications from a qualitative analysis of the scientific literature. Learn Health Syst. 2021;6(2):e10287. doi:10.1002/LRH2.10287
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Consider Cultural Practices and Barriers to Care When Treating Alopecia Areata

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Consider Cultural Practices and Barriers to Care When Treating Alopecia Areata

The Comparison

A. Alopecia areata in a young girl with a lighter skin tone. The fine white vellus hairs are signs of regrowth. 

B. Alopecia areata in a 49-year-old man with tightly coiled hair and darker skin tone. Coiled white hairs are noted in the alopecia patches.

0825Fed-Cutis-Fa
Alopecia areata in a
young girl with a lighter skin
tone. The fine white vellus
hairs are signs of regrowth. Photographs courtesy of
Richard P. Usatine, MD.
0825Fed-Cutis-Fb
Alopecia areata in a
49-year-old man with tightly
coiled hair and darker skin
tone. Coiled white hairs
are noted in the alopecia
patches. Photographs courtesy of
Richard P. Usatine, MD.

Alopecia areata (AA) is a common autoimmune condition characterized by hair loss resulting from a T cell–mediated attack on the hair follicles. It manifests as nonscarring patches of hair loss on the scalp, eyebrows, eyelashes, and beard area as well as more extensive complete loss of scalp and body hair. While AA may affect individuals of any age, most patients develop their first patch(es) of hair loss during childhood.1 The treatment landscape for AA has evolved considerably in recent years, but barriers to access to newer treatments persist. 

Epidemiology 

AA is most prevalent among pediatric and adult individuals of African, Asian, or Hispanic/Latino descent.2-4 In some studies, Black individuals had higher odds and Asian individuals had lower odds of developing AA, while other studies have reported the highest standardized prevalence among Asian individuals.5 In the United States, AA affects about 1.47% of adults and as many as 0.11% of children.6-8 In Black patients, AA often manifests early with a female predominance.5 

AA frequently is associated with autoimmune comorbidities, the most common being thyroid disease.3,5 In Black patients, AA is associated with more atopic comorbidities, including asthma, atopic dermatitis, and allergic rhinitis.5 

Key Clinical Features 

AA clinically manifests similarly across different skin tones; however, in patients with more tightly coiled or curly hair, the extent of scalp hair loss may be underestimated without a full examination. Culturally sensitive approaches to hair and scalp evaluation are essential, especially for Black women, whose hair care practices and scalp conditions may be overlooked or misunderstood during visits to evaluate hair loss. A thoughtful history and gentle examination of the hair and scalp that considers hair texture, cultural practices such as head coverings (eg, headwraps, turbans, hijabs), use of hair adornments (eg, clips, beads, bows), traditional braiding, and use of natural oils or herbal treatments, as well as styling methods including tight hairstyles, use of heat styling tools (eg, flat irons, curling irons), chemical application (eg, straighteners, hair color), and washing or styling frequency can improve diagnostic accuracy and help build trust in the patient-provider relationship. 

Classic signs of AA visualized with dermoscopy include yellow and/or black dots on the scalp and exclamation point hairs. The appearance of fine white vellus hairs within the alopecic patches also may indicate early regrowth. On scalp trichoscopy, black dots are more prominent, and yellow dots are less prominent, in individuals with darker skin tones vs lighter skin tones.9 

Worth Noting 

In addition to a full examination of the scalp, documenting the extent of hair loss using validated severity scales, including the severity of alopecia tool (SALT), AA severity index (AASI), clinician-reported outcome assessment, and patient-reported outcome measures, can standardize disease severity assessment, facilitate timely insurance or medication approvals, and support objective tracking of treatment response, which may ultimately enhance access to care.10 

Prompt treatment of AA is essential. Not surprisingly, patients given a diagnosis of AA may experience considerable emotional and psychological distress—regardless of the extent of the loss.11 Treatment options include mid- to high-potency topical or intralesional corticosteroids and newer and more targeted systemic options, including 3 Janus kinase (JAK) inhibitors—baricitinib, ritlecitinib, and deuruxolitinib—for more extensive disease.12 Treatment with intralesional corticosteroids may cause transient hypopigmentation, which may be more noticeable in patients with darker skin tones. Delays in treatment with JAK inhibitors can lead to a less-than-optimal response. Of the 3 JAK inhibitors that are approved by the US Food and Drug Administration for AA, only ritlecitinib is approved for children 12 years and older, leaving a therapeutic gap for younger patients that often leads to uncomfortable scalp injections, delayed or no treatment, off-label use of JAK inhibitors as well as the pairing of off-label dupilumab with oral minoxidil.12 

Based on adult data, patients with severe disease and a shorter duration of hair loss (ie, < 4 years) tend to respond better to JAK inhibitors than those experiencing hair loss for longer periods. Also, those with more severe AA tend to have poorer outcomes than those with less severe disease.13 If treatment proves less than optimal, wigs and hair pieces may need to be considered. It is worth noting that some insurance companies will cover the cost of wigs for patients when prescribed as cranial prostheses. 

Health Disparity Highlight 

Health disparities in AA can be influenced by socioeconomic status and access to care. Patients from lower-income backgrounds often face barriers to accessing dermatologic care and treatments such as JAK inhibitors, which may remain inaccessible due to high costs and insurance limitations.14 These barriers can intersect with other factors such as age, sex, and race, potentially exacerbating disparities. Women with skin of color in underserved communities may experience delayed diagnosis, limited treatment options, and greater psychosocial distress from hair loss.14 Addressing these inequities requires advocacy, education for both patients and clinicians, and improved access to treatment to ensure comprehensive care for all patients. 

References
  1. Kara T, Topkarcı Z. Interactions between posttraumatic stress disorder and alopecia areata in child with trauma exposure: two case reports. Int J Trichology. 2018;10:131-134. doi:10.4103/ijt.ijt_2_18 
  2. Sy N, Mastacouris N, Strunk A, et al. Overall and racial and ethnic subgroup prevalences of alopecia areata, alopecia totalis, and alopecia universalis. JAMA Dermatol. 2023;159:419-423. 
  3. Lee H, Jung SJ, Patel AB, et al. Racial characteristics of alopecia areata in the United States. J Am Acad Dermatol. 2020;83:1064-1070. 
  4. Feaster B, McMichael AJ. Epidemiology of alopecia areata in Black patients: a retrospective chart review. J Am Acad Dermatol. 2022;87:1121-1123. 
  5. Lee HH, Gwillim E, Patel KR, et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: a systematic review and meta-analysis. J Am Acad Dermatol. 2020;82:675-682. 
  6. Mostaghimi A, Gao W, Ray M, et al. Trends in prevalence and incidence of alopecia areata, alopecia totalis, and alopecia universalis among adults and children in a US employer-sponsored insured population. JAMA Dermatol. 2023;159:411-418. 
  7. Adhanom R, Ansbro B, Castelo-Soccio L. Epidemiology of pediatric alopecia areata. Pediatr Dermatol. 2025;42 suppl 1(suppl 1):12-23. 
  8. Karampinis E, Toli O, Georgopoulou KE, et al. Exploring pediatric dermatology in skin of color: focus on dermoscopy. Life (Basel). 2024;14:1604. 
  9. King BA, Senna MM, Ohyama M, et al. Defining severity in alopecia areata: current perspectives and a multidimensional framework. Dermatol Ther (Heidelb). 2022;12:825-834. 
  10. Toussi A, Barton VR, Le ST, et al. Psychosocial and psychiatric comorbidities and health-related quality of life in alopecia areata: a systematic review. J Am Acad Dermatol. 2021;85:162-175. 
  11. Kalil L, Welch D, Heath CR, et al. Systemic therapies for pediatric alopecia areata. Pediatr Dermatol. 2025;42 suppl 1:36-42. 
  12. King BA, Craiglow BG. Janus kinase inhibitors for alopecia areata. J Am Acad Dermatol. 2023;89:S29-S32. 
  13. Klein EJ, Taiwò D, Kakpovbia E, et al. Disparities in Janus kinase inhibitor access for alopecia areata: a retrospective analysis. Int J Womens Dermatol. 2024;10:E155. 
  14. McKenzie PL, Maltenfort M, Bruckner AL, et al. Evaluation of the prevalence and incidence of pediatric alopecia areata using electronic health record data. JAMA Dermatol. 2022;158:547-551. doi:10.1001/jamadermatol.2022.0351
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The Comparison

A. Alopecia areata in a young girl with a lighter skin tone. The fine white vellus hairs are signs of regrowth. 

B. Alopecia areata in a 49-year-old man with tightly coiled hair and darker skin tone. Coiled white hairs are noted in the alopecia patches.

0825Fed-Cutis-Fa
Alopecia areata in a
young girl with a lighter skin
tone. The fine white vellus
hairs are signs of regrowth. Photographs courtesy of
Richard P. Usatine, MD.
0825Fed-Cutis-Fb
Alopecia areata in a
49-year-old man with tightly
coiled hair and darker skin
tone. Coiled white hairs
are noted in the alopecia
patches. Photographs courtesy of
Richard P. Usatine, MD.

Alopecia areata (AA) is a common autoimmune condition characterized by hair loss resulting from a T cell–mediated attack on the hair follicles. It manifests as nonscarring patches of hair loss on the scalp, eyebrows, eyelashes, and beard area as well as more extensive complete loss of scalp and body hair. While AA may affect individuals of any age, most patients develop their first patch(es) of hair loss during childhood.1 The treatment landscape for AA has evolved considerably in recent years, but barriers to access to newer treatments persist. 

Epidemiology 

AA is most prevalent among pediatric and adult individuals of African, Asian, or Hispanic/Latino descent.2-4 In some studies, Black individuals had higher odds and Asian individuals had lower odds of developing AA, while other studies have reported the highest standardized prevalence among Asian individuals.5 In the United States, AA affects about 1.47% of adults and as many as 0.11% of children.6-8 In Black patients, AA often manifests early with a female predominance.5 

AA frequently is associated with autoimmune comorbidities, the most common being thyroid disease.3,5 In Black patients, AA is associated with more atopic comorbidities, including asthma, atopic dermatitis, and allergic rhinitis.5 

Key Clinical Features 

AA clinically manifests similarly across different skin tones; however, in patients with more tightly coiled or curly hair, the extent of scalp hair loss may be underestimated without a full examination. Culturally sensitive approaches to hair and scalp evaluation are essential, especially for Black women, whose hair care practices and scalp conditions may be overlooked or misunderstood during visits to evaluate hair loss. A thoughtful history and gentle examination of the hair and scalp that considers hair texture, cultural practices such as head coverings (eg, headwraps, turbans, hijabs), use of hair adornments (eg, clips, beads, bows), traditional braiding, and use of natural oils or herbal treatments, as well as styling methods including tight hairstyles, use of heat styling tools (eg, flat irons, curling irons), chemical application (eg, straighteners, hair color), and washing or styling frequency can improve diagnostic accuracy and help build trust in the patient-provider relationship. 

Classic signs of AA visualized with dermoscopy include yellow and/or black dots on the scalp and exclamation point hairs. The appearance of fine white vellus hairs within the alopecic patches also may indicate early regrowth. On scalp trichoscopy, black dots are more prominent, and yellow dots are less prominent, in individuals with darker skin tones vs lighter skin tones.9 

Worth Noting 

In addition to a full examination of the scalp, documenting the extent of hair loss using validated severity scales, including the severity of alopecia tool (SALT), AA severity index (AASI), clinician-reported outcome assessment, and patient-reported outcome measures, can standardize disease severity assessment, facilitate timely insurance or medication approvals, and support objective tracking of treatment response, which may ultimately enhance access to care.10 

Prompt treatment of AA is essential. Not surprisingly, patients given a diagnosis of AA may experience considerable emotional and psychological distress—regardless of the extent of the loss.11 Treatment options include mid- to high-potency topical or intralesional corticosteroids and newer and more targeted systemic options, including 3 Janus kinase (JAK) inhibitors—baricitinib, ritlecitinib, and deuruxolitinib—for more extensive disease.12 Treatment with intralesional corticosteroids may cause transient hypopigmentation, which may be more noticeable in patients with darker skin tones. Delays in treatment with JAK inhibitors can lead to a less-than-optimal response. Of the 3 JAK inhibitors that are approved by the US Food and Drug Administration for AA, only ritlecitinib is approved for children 12 years and older, leaving a therapeutic gap for younger patients that often leads to uncomfortable scalp injections, delayed or no treatment, off-label use of JAK inhibitors as well as the pairing of off-label dupilumab with oral minoxidil.12 

Based on adult data, patients with severe disease and a shorter duration of hair loss (ie, < 4 years) tend to respond better to JAK inhibitors than those experiencing hair loss for longer periods. Also, those with more severe AA tend to have poorer outcomes than those with less severe disease.13 If treatment proves less than optimal, wigs and hair pieces may need to be considered. It is worth noting that some insurance companies will cover the cost of wigs for patients when prescribed as cranial prostheses. 

Health Disparity Highlight 

Health disparities in AA can be influenced by socioeconomic status and access to care. Patients from lower-income backgrounds often face barriers to accessing dermatologic care and treatments such as JAK inhibitors, which may remain inaccessible due to high costs and insurance limitations.14 These barriers can intersect with other factors such as age, sex, and race, potentially exacerbating disparities. Women with skin of color in underserved communities may experience delayed diagnosis, limited treatment options, and greater psychosocial distress from hair loss.14 Addressing these inequities requires advocacy, education for both patients and clinicians, and improved access to treatment to ensure comprehensive care for all patients. 

The Comparison

A. Alopecia areata in a young girl with a lighter skin tone. The fine white vellus hairs are signs of regrowth. 

B. Alopecia areata in a 49-year-old man with tightly coiled hair and darker skin tone. Coiled white hairs are noted in the alopecia patches.

0825Fed-Cutis-Fa
Alopecia areata in a
young girl with a lighter skin
tone. The fine white vellus
hairs are signs of regrowth. Photographs courtesy of
Richard P. Usatine, MD.
0825Fed-Cutis-Fb
Alopecia areata in a
49-year-old man with tightly
coiled hair and darker skin
tone. Coiled white hairs
are noted in the alopecia
patches. Photographs courtesy of
Richard P. Usatine, MD.

Alopecia areata (AA) is a common autoimmune condition characterized by hair loss resulting from a T cell–mediated attack on the hair follicles. It manifests as nonscarring patches of hair loss on the scalp, eyebrows, eyelashes, and beard area as well as more extensive complete loss of scalp and body hair. While AA may affect individuals of any age, most patients develop their first patch(es) of hair loss during childhood.1 The treatment landscape for AA has evolved considerably in recent years, but barriers to access to newer treatments persist. 

Epidemiology 

AA is most prevalent among pediatric and adult individuals of African, Asian, or Hispanic/Latino descent.2-4 In some studies, Black individuals had higher odds and Asian individuals had lower odds of developing AA, while other studies have reported the highest standardized prevalence among Asian individuals.5 In the United States, AA affects about 1.47% of adults and as many as 0.11% of children.6-8 In Black patients, AA often manifests early with a female predominance.5 

AA frequently is associated with autoimmune comorbidities, the most common being thyroid disease.3,5 In Black patients, AA is associated with more atopic comorbidities, including asthma, atopic dermatitis, and allergic rhinitis.5 

Key Clinical Features 

AA clinically manifests similarly across different skin tones; however, in patients with more tightly coiled or curly hair, the extent of scalp hair loss may be underestimated without a full examination. Culturally sensitive approaches to hair and scalp evaluation are essential, especially for Black women, whose hair care practices and scalp conditions may be overlooked or misunderstood during visits to evaluate hair loss. A thoughtful history and gentle examination of the hair and scalp that considers hair texture, cultural practices such as head coverings (eg, headwraps, turbans, hijabs), use of hair adornments (eg, clips, beads, bows), traditional braiding, and use of natural oils or herbal treatments, as well as styling methods including tight hairstyles, use of heat styling tools (eg, flat irons, curling irons), chemical application (eg, straighteners, hair color), and washing or styling frequency can improve diagnostic accuracy and help build trust in the patient-provider relationship. 

Classic signs of AA visualized with dermoscopy include yellow and/or black dots on the scalp and exclamation point hairs. The appearance of fine white vellus hairs within the alopecic patches also may indicate early regrowth. On scalp trichoscopy, black dots are more prominent, and yellow dots are less prominent, in individuals with darker skin tones vs lighter skin tones.9 

Worth Noting 

In addition to a full examination of the scalp, documenting the extent of hair loss using validated severity scales, including the severity of alopecia tool (SALT), AA severity index (AASI), clinician-reported outcome assessment, and patient-reported outcome measures, can standardize disease severity assessment, facilitate timely insurance or medication approvals, and support objective tracking of treatment response, which may ultimately enhance access to care.10 

Prompt treatment of AA is essential. Not surprisingly, patients given a diagnosis of AA may experience considerable emotional and psychological distress—regardless of the extent of the loss.11 Treatment options include mid- to high-potency topical or intralesional corticosteroids and newer and more targeted systemic options, including 3 Janus kinase (JAK) inhibitors—baricitinib, ritlecitinib, and deuruxolitinib—for more extensive disease.12 Treatment with intralesional corticosteroids may cause transient hypopigmentation, which may be more noticeable in patients with darker skin tones. Delays in treatment with JAK inhibitors can lead to a less-than-optimal response. Of the 3 JAK inhibitors that are approved by the US Food and Drug Administration for AA, only ritlecitinib is approved for children 12 years and older, leaving a therapeutic gap for younger patients that often leads to uncomfortable scalp injections, delayed or no treatment, off-label use of JAK inhibitors as well as the pairing of off-label dupilumab with oral minoxidil.12 

Based on adult data, patients with severe disease and a shorter duration of hair loss (ie, < 4 years) tend to respond better to JAK inhibitors than those experiencing hair loss for longer periods. Also, those with more severe AA tend to have poorer outcomes than those with less severe disease.13 If treatment proves less than optimal, wigs and hair pieces may need to be considered. It is worth noting that some insurance companies will cover the cost of wigs for patients when prescribed as cranial prostheses. 

Health Disparity Highlight 

Health disparities in AA can be influenced by socioeconomic status and access to care. Patients from lower-income backgrounds often face barriers to accessing dermatologic care and treatments such as JAK inhibitors, which may remain inaccessible due to high costs and insurance limitations.14 These barriers can intersect with other factors such as age, sex, and race, potentially exacerbating disparities. Women with skin of color in underserved communities may experience delayed diagnosis, limited treatment options, and greater psychosocial distress from hair loss.14 Addressing these inequities requires advocacy, education for both patients and clinicians, and improved access to treatment to ensure comprehensive care for all patients. 

References
  1. Kara T, Topkarcı Z. Interactions between posttraumatic stress disorder and alopecia areata in child with trauma exposure: two case reports. Int J Trichology. 2018;10:131-134. doi:10.4103/ijt.ijt_2_18 
  2. Sy N, Mastacouris N, Strunk A, et al. Overall and racial and ethnic subgroup prevalences of alopecia areata, alopecia totalis, and alopecia universalis. JAMA Dermatol. 2023;159:419-423. 
  3. Lee H, Jung SJ, Patel AB, et al. Racial characteristics of alopecia areata in the United States. J Am Acad Dermatol. 2020;83:1064-1070. 
  4. Feaster B, McMichael AJ. Epidemiology of alopecia areata in Black patients: a retrospective chart review. J Am Acad Dermatol. 2022;87:1121-1123. 
  5. Lee HH, Gwillim E, Patel KR, et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: a systematic review and meta-analysis. J Am Acad Dermatol. 2020;82:675-682. 
  6. Mostaghimi A, Gao W, Ray M, et al. Trends in prevalence and incidence of alopecia areata, alopecia totalis, and alopecia universalis among adults and children in a US employer-sponsored insured population. JAMA Dermatol. 2023;159:411-418. 
  7. Adhanom R, Ansbro B, Castelo-Soccio L. Epidemiology of pediatric alopecia areata. Pediatr Dermatol. 2025;42 suppl 1(suppl 1):12-23. 
  8. Karampinis E, Toli O, Georgopoulou KE, et al. Exploring pediatric dermatology in skin of color: focus on dermoscopy. Life (Basel). 2024;14:1604. 
  9. King BA, Senna MM, Ohyama M, et al. Defining severity in alopecia areata: current perspectives and a multidimensional framework. Dermatol Ther (Heidelb). 2022;12:825-834. 
  10. Toussi A, Barton VR, Le ST, et al. Psychosocial and psychiatric comorbidities and health-related quality of life in alopecia areata: a systematic review. J Am Acad Dermatol. 2021;85:162-175. 
  11. Kalil L, Welch D, Heath CR, et al. Systemic therapies for pediatric alopecia areata. Pediatr Dermatol. 2025;42 suppl 1:36-42. 
  12. King BA, Craiglow BG. Janus kinase inhibitors for alopecia areata. J Am Acad Dermatol. 2023;89:S29-S32. 
  13. Klein EJ, Taiwò D, Kakpovbia E, et al. Disparities in Janus kinase inhibitor access for alopecia areata: a retrospective analysis. Int J Womens Dermatol. 2024;10:E155. 
  14. McKenzie PL, Maltenfort M, Bruckner AL, et al. Evaluation of the prevalence and incidence of pediatric alopecia areata using electronic health record data. JAMA Dermatol. 2022;158:547-551. doi:10.1001/jamadermatol.2022.0351
References
  1. Kara T, Topkarcı Z. Interactions between posttraumatic stress disorder and alopecia areata in child with trauma exposure: two case reports. Int J Trichology. 2018;10:131-134. doi:10.4103/ijt.ijt_2_18 
  2. Sy N, Mastacouris N, Strunk A, et al. Overall and racial and ethnic subgroup prevalences of alopecia areata, alopecia totalis, and alopecia universalis. JAMA Dermatol. 2023;159:419-423. 
  3. Lee H, Jung SJ, Patel AB, et al. Racial characteristics of alopecia areata in the United States. J Am Acad Dermatol. 2020;83:1064-1070. 
  4. Feaster B, McMichael AJ. Epidemiology of alopecia areata in Black patients: a retrospective chart review. J Am Acad Dermatol. 2022;87:1121-1123. 
  5. Lee HH, Gwillim E, Patel KR, et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: a systematic review and meta-analysis. J Am Acad Dermatol. 2020;82:675-682. 
  6. Mostaghimi A, Gao W, Ray M, et al. Trends in prevalence and incidence of alopecia areata, alopecia totalis, and alopecia universalis among adults and children in a US employer-sponsored insured population. JAMA Dermatol. 2023;159:411-418. 
  7. Adhanom R, Ansbro B, Castelo-Soccio L. Epidemiology of pediatric alopecia areata. Pediatr Dermatol. 2025;42 suppl 1(suppl 1):12-23. 
  8. Karampinis E, Toli O, Georgopoulou KE, et al. Exploring pediatric dermatology in skin of color: focus on dermoscopy. Life (Basel). 2024;14:1604. 
  9. King BA, Senna MM, Ohyama M, et al. Defining severity in alopecia areata: current perspectives and a multidimensional framework. Dermatol Ther (Heidelb). 2022;12:825-834. 
  10. Toussi A, Barton VR, Le ST, et al. Psychosocial and psychiatric comorbidities and health-related quality of life in alopecia areata: a systematic review. J Am Acad Dermatol. 2021;85:162-175. 
  11. Kalil L, Welch D, Heath CR, et al. Systemic therapies for pediatric alopecia areata. Pediatr Dermatol. 2025;42 suppl 1:36-42. 
  12. King BA, Craiglow BG. Janus kinase inhibitors for alopecia areata. J Am Acad Dermatol. 2023;89:S29-S32. 
  13. Klein EJ, Taiwò D, Kakpovbia E, et al. Disparities in Janus kinase inhibitor access for alopecia areata: a retrospective analysis. Int J Womens Dermatol. 2024;10:E155. 
  14. McKenzie PL, Maltenfort M, Bruckner AL, et al. Evaluation of the prevalence and incidence of pediatric alopecia areata using electronic health record data. JAMA Dermatol. 2022;158:547-551. doi:10.1001/jamadermatol.2022.0351
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A Voice for Those Caring for Veterans With Cancer

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A Voice for Those Caring for Veterans With Cancer

At some point, most Americans will experience the anxiety associated with an organizational restructure or a corporate budget cut that leads to job loss. Self-assurances may follow by telling ourselves we will be fine, and we could even start a new position that (if we're lucky) will be better than our previous one. It can be devastating, but is not a life-or-death scenario.

Unless you care for veterans with cancer.

The recent workforce reductions across the US Department of Veterans of Affairs (VA) health care system, whether through voluntary retirements or forced layoffs, is a life-threatening crisis. Every position lost has the potential to directly impact whether a veteran receives the necessary care in their battle with cancer.

Veterans deserve every opportunity, treatment plan, and resource available to ensure their comfort and survival. They are entitled to the specialized, comprehensive, and thorough care they receive through the VAcare that cannot be duplicated in community health care. Because many of the health challenges they face are a direct result of serving our country, we owe it to them to provide the best care available from the most highly-trained and competent clinicians. This level of excellence cannot be achieved in a gutted or chaotic system.

Reducing or eliminating VA health care positions is a decision that demands careful examination. Like any organization, the VA experiences some measure of waste or inefficiency that should be eliminated. But that cannot be done swiftly or in large-scale action.

Consider these examples: the reduction of force resulting in the removal of those deemed to hold unnecessary administrative positionssuch as continuing education or physician oversighthas a direct impact on a clinician's ability to provide the most current and precise care. Reduced research funding limits the VA's contribution to health care innovation. The loss of contract positions that appear superfluous on paper represent the staff who schedule appointments, chemotherapy or radiation therapy, and wrap-around services for veterans. Even reducing auxiliary services like laundry may seem like a cost-saving measureuntil the hospital can't admit new patients due to lack of sanitized linens.

VA employees know that veterans need specialized care for their complex and unique challenges. That individualized care has led to the VA nearly eliminating disparity gaps experienced in traditional health care. The removal of support positions and opportunities in professional development demands coordination with less-prepared community-based health care; overpopulated work environments will have a lasting impact. Limiting the workforce will make it impossible to provide coordinated and exceptional care.

The Association of VA Hematology/Oncology (AVAHO) is a leader in professional development opportunities for those who care for veterans with cancer. As a nonprofit organization, AVAHO is also a voice for those working with veterans with cancer to ensure they receive the care they deserve. AVAHO is calling on its colleagues, veterans, and those committed to supporting veterans to voice their opposition to reducing critical staff, research, and resources within the VA.

We ask veterans to share stories describing the difference VA care makes. We ask cliniciansincluding those within the federal systemto explain how a system that is well-staffed, supported, and with ample resources can impact patient care. Americans must stand for the care our veterans have earned.

Most importantly, we call on policymakers to carefully consider the impact each position has on the outcome of excellent, well-coordinated, and state-of-the-art care. The lives of our veterans depend on it.

AVAHO is a 501(c)3 nonprofit organization dedicated to supporting and educating health care providers who serve veterans with cancer and hematological disorders. You can find out more and support their advocacy initiatives at www.avaho.org.

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Fed Pract. 2025;42(suppl 3). Published online August 12. doi:10.12788/fp.0615

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Fed Pract. 2025;42(suppl 3). Published online August 12. doi:10.12788/fp.0615

At some point, most Americans will experience the anxiety associated with an organizational restructure or a corporate budget cut that leads to job loss. Self-assurances may follow by telling ourselves we will be fine, and we could even start a new position that (if we're lucky) will be better than our previous one. It can be devastating, but is not a life-or-death scenario.

Unless you care for veterans with cancer.

The recent workforce reductions across the US Department of Veterans of Affairs (VA) health care system, whether through voluntary retirements or forced layoffs, is a life-threatening crisis. Every position lost has the potential to directly impact whether a veteran receives the necessary care in their battle with cancer.

Veterans deserve every opportunity, treatment plan, and resource available to ensure their comfort and survival. They are entitled to the specialized, comprehensive, and thorough care they receive through the VAcare that cannot be duplicated in community health care. Because many of the health challenges they face are a direct result of serving our country, we owe it to them to provide the best care available from the most highly-trained and competent clinicians. This level of excellence cannot be achieved in a gutted or chaotic system.

Reducing or eliminating VA health care positions is a decision that demands careful examination. Like any organization, the VA experiences some measure of waste or inefficiency that should be eliminated. But that cannot be done swiftly or in large-scale action.

Consider these examples: the reduction of force resulting in the removal of those deemed to hold unnecessary administrative positionssuch as continuing education or physician oversighthas a direct impact on a clinician's ability to provide the most current and precise care. Reduced research funding limits the VA's contribution to health care innovation. The loss of contract positions that appear superfluous on paper represent the staff who schedule appointments, chemotherapy or radiation therapy, and wrap-around services for veterans. Even reducing auxiliary services like laundry may seem like a cost-saving measureuntil the hospital can't admit new patients due to lack of sanitized linens.

VA employees know that veterans need specialized care for their complex and unique challenges. That individualized care has led to the VA nearly eliminating disparity gaps experienced in traditional health care. The removal of support positions and opportunities in professional development demands coordination with less-prepared community-based health care; overpopulated work environments will have a lasting impact. Limiting the workforce will make it impossible to provide coordinated and exceptional care.

The Association of VA Hematology/Oncology (AVAHO) is a leader in professional development opportunities for those who care for veterans with cancer. As a nonprofit organization, AVAHO is also a voice for those working with veterans with cancer to ensure they receive the care they deserve. AVAHO is calling on its colleagues, veterans, and those committed to supporting veterans to voice their opposition to reducing critical staff, research, and resources within the VA.

We ask veterans to share stories describing the difference VA care makes. We ask cliniciansincluding those within the federal systemto explain how a system that is well-staffed, supported, and with ample resources can impact patient care. Americans must stand for the care our veterans have earned.

Most importantly, we call on policymakers to carefully consider the impact each position has on the outcome of excellent, well-coordinated, and state-of-the-art care. The lives of our veterans depend on it.

AVAHO is a 501(c)3 nonprofit organization dedicated to supporting and educating health care providers who serve veterans with cancer and hematological disorders. You can find out more and support their advocacy initiatives at www.avaho.org.

At some point, most Americans will experience the anxiety associated with an organizational restructure or a corporate budget cut that leads to job loss. Self-assurances may follow by telling ourselves we will be fine, and we could even start a new position that (if we're lucky) will be better than our previous one. It can be devastating, but is not a life-or-death scenario.

Unless you care for veterans with cancer.

The recent workforce reductions across the US Department of Veterans of Affairs (VA) health care system, whether through voluntary retirements or forced layoffs, is a life-threatening crisis. Every position lost has the potential to directly impact whether a veteran receives the necessary care in their battle with cancer.

Veterans deserve every opportunity, treatment plan, and resource available to ensure their comfort and survival. They are entitled to the specialized, comprehensive, and thorough care they receive through the VAcare that cannot be duplicated in community health care. Because many of the health challenges they face are a direct result of serving our country, we owe it to them to provide the best care available from the most highly-trained and competent clinicians. This level of excellence cannot be achieved in a gutted or chaotic system.

Reducing or eliminating VA health care positions is a decision that demands careful examination. Like any organization, the VA experiences some measure of waste or inefficiency that should be eliminated. But that cannot be done swiftly or in large-scale action.

Consider these examples: the reduction of force resulting in the removal of those deemed to hold unnecessary administrative positionssuch as continuing education or physician oversighthas a direct impact on a clinician's ability to provide the most current and precise care. Reduced research funding limits the VA's contribution to health care innovation. The loss of contract positions that appear superfluous on paper represent the staff who schedule appointments, chemotherapy or radiation therapy, and wrap-around services for veterans. Even reducing auxiliary services like laundry may seem like a cost-saving measureuntil the hospital can't admit new patients due to lack of sanitized linens.

VA employees know that veterans need specialized care for their complex and unique challenges. That individualized care has led to the VA nearly eliminating disparity gaps experienced in traditional health care. The removal of support positions and opportunities in professional development demands coordination with less-prepared community-based health care; overpopulated work environments will have a lasting impact. Limiting the workforce will make it impossible to provide coordinated and exceptional care.

The Association of VA Hematology/Oncology (AVAHO) is a leader in professional development opportunities for those who care for veterans with cancer. As a nonprofit organization, AVAHO is also a voice for those working with veterans with cancer to ensure they receive the care they deserve. AVAHO is calling on its colleagues, veterans, and those committed to supporting veterans to voice their opposition to reducing critical staff, research, and resources within the VA.

We ask veterans to share stories describing the difference VA care makes. We ask cliniciansincluding those within the federal systemto explain how a system that is well-staffed, supported, and with ample resources can impact patient care. Americans must stand for the care our veterans have earned.

Most importantly, we call on policymakers to carefully consider the impact each position has on the outcome of excellent, well-coordinated, and state-of-the-art care. The lives of our veterans depend on it.

AVAHO is a 501(c)3 nonprofit organization dedicated to supporting and educating health care providers who serve veterans with cancer and hematological disorders. You can find out more and support their advocacy initiatives at www.avaho.org.

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Evaluation of Subcutaneous Contraception for Patient Self-Administration at North Florida/South Georgia Veterans Health System

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Evaluation of Subcutaneous Contraception for Patient Self-Administration at North Florida/South Georgia Veterans Health System

Medroxyprogesterone acetate is an injectable medication indicated for contraception and management of endometriosis-associated pain in females of reproductive age.1 Medroxyprogesterone inhibits gonadotropin secretion, which prevents follicular maturation and ovulation. This leads to endometrial thinning and a contraceptive effect. Adverse drug reactions (ADRs), such as weight gain, menstrual bleeding irregularities, and bone loss appear to be dose- and time-related. Two formulations of medroxyprogesterone acetate are available: 150 mg depot medroxyprogesterone acetate intramuscular (DMPA-IM) and 104 mg DMPA subcutaneous (DMPA-SC).2 Originally, medroxyprogesterone acetate injections required administration by a health care worker. While the current labeling for DMPA-SC still indicates a requirement for administration by a health care worker, data show that the medication can be safe and effective when self-administered.3

Self-Administered Contraception

The 2019 World Health Organization (WHO) guideline on self-care interventions recommends making self-administered injectable contraception available to individuals of reproductive age.3 The WHO recommendation is based on evidence from the Depo Self-Administration Study, which included 401 patients randomized 1:1 to receive self-administered or clinic-administered DMPA-SC. This study concluded that self-administration improved continuation of contraception.4

The North Florida/South Georgia Veterans Health System (NFSGVHS) is the largest US Department of Veterans Affairs (VA) health care system, serving > 22,000 female veterans. All primary care practitioners (PCP) have been trained in women’s health (WH). 

The WH patient-aligned care team (PACT) clinical pharmacy practitioner (CPP) proposed using DMPA-SC for outpatient self-administration to increase access, improve patient satisfaction, and reduce burden on patients and nurses for administration appointments. The Pharmacy and Therapeutics Committee (P&T), WH Medical Director, and Chief of Gynecology approved the proposal. DMPA-SC was added to the ordering menu with order sets. The order set included instructions that outlined the 12-week dosing interval, instructions to contact the prescriber if the injection was > 2 weeks overdue (aligning with dosing recommendations for administration every 12 to 14 weeks), and an optional order for a home pregnancy test if necessary. These instructions were designed to ensure proper self-administration of the medication and timely follow-up care. 

The gynecology and PACT health care practitioners (HCPs), including physicians, pharmacists, nurses, and medical assistants, received DMPA-SC education, which consisted of a review of medication, ADRs, contraindications, and administration. An NFSGVHS procedure was developed to ensure patients received self-administration education. DMPA-SC prescriptions were mailed to patients with scheduled nursing appointments. The patient would then bring DMPA-SC to the nursing appointment where they received administration instruction and completed the first injection under nurse supervision to ensure appropriate technique. Patients were offered supplementary educational documents and a calendar to keep track of injection days. The patients were responsible for ordering refills and administering subsequent injections at home. Once all stakeholders received education and order sets were in place, prescribers and nurses could begin offering the option for initiation of self-administered DMPA-SC to patients. All conversions or new prescriptions were initiated by prescribers as a part of usual care.

Medication Use Evaluation

A medication use evaluation was conducted about 1 year after the rollout to assess use, adherence, and impact of DMPA-SC for patient-self administration as a new contraceptive option for NFSGVHS patients.

A retrospective chart review was conducted for patients dispensed DMPA-SC from June 1, 2022, to July 1, 2023. Baseline body mass index (BMI), recorded prior to initiation of DMPA-SC, was compared with the most recent BMI on record at the completion of the study to evaluate weight change. Nursing visit attendance for the first injection was also assessed. Adherence was evaluated by reviewing the date of the initial DMPA-SC prescription, the date of the patient's first nursing visit, and subsequent refill patterns. A 2-week margin of error was established to account for the flexibility within the recommended dosing interval and delays in postal service delivery.

Forty patients were initiated on DMPA-SC for patient self-administration. The mean age of patients was 37.2 years. All 40 patients were female. Twenty-two patients (55%) identified as Black, 17 (43%) as White, and 1 (3%) as Asian. The majority (90%) of patients were non-Hispanic. The mean baseline BMI was 30 and BMI after DMPA-SC initiation was 30.4.

Twenty-eight (70%) patients had a nursing appointment, adhering to the NFSGVHS protocol. Five patients (13%) discontinued use and switched to DMPA-IM administered by an HCP and 4 (10%) discontinued use following an ADR (hives, mood changes, bruising, and menometrorrhagia). Of the 31 patients who continued therapy, 25 (81%) were refilling appropriately (Table). 

FDP04208314_T

Six patients with unidentified reasons for nonadherence were contacted to determine if there were unmet contraceptive needs. This subgroup included patients with an active prescription for DMPA-SC that did not meet refill expectations. Nonadherence was mostly due to forgetfulness, however 1 patient was unable to refill her DMPA-SC in a timely manner due to an outside hospital admission and another was unreachable. These conversations were documented in the electronic health record (EHR) and all patients requesting follow-up, reinitiation of therapy, or alternative regimens, the appropriate parties were notified to coordinate care.

Discussion

The uptake in DMPA-SC prescribing suggests prescribers and patients have embraced self-administration as an option for contraception. Most patients were appropriately scheduled for nursing appointments to reinforce education and ensure appropriate self-injection technique, as outlined in the NFSGVHS procedure.

The need to improve adherence to NFSGVHS procedure was identified because not all patients had scheduled nursing appointments. This is concerning because some patients may have started self-injecting DMPA-SC without proper education, which could lead to improper injection technique and diminished effectiveness. Nursing appointments ensure appropriate self-injection techniques and reinforce the importance of refilling every 12 weeks for proper effectiveness. Nonadherence to contraceptive therapy may result in unintended pregnancy, although no pregnancies were reported by patients in this study. Pharmacist involvement in DMPA-SC initiation and follow-up monitoring may help ensure adherence to local procedure for initiation and improve patient adherence. 

There is limited evidence comparing weight gain related to DMPA-SC vs DMPA-IM. However, in a small, 2-year, randomized study, weight changes were considered comparable for both cohorts with a mean increase of 3.5 kg in the DMPA-IM group vs 3.4 kg in the DMPA-SC group.5 While our analysis did not formally evaluate weight changes, BMI data were collected to evaluate for evidence of weight change. The duration of therapy varied per patient and may not have been long enough to see comparable weight changes. 

Strengths of this project include the use of the PACT multidisciplinary approach in primary care including physicians, pharmacists, and nurses. The NFSGVHS EHR is comprehensive, and data including appointments and pharmacy refill information was readily available for collection and evaluation. Limitations included inconsistent documentation in the patient’s EHR which made collection of some data difficult.

Cost Estimates

NFSGVHS had 231 patients prescribed DMPA-IM at the time of DMPA-SC rollout and 40 patients initiated DMPA-SC therapy in the first year. There are possible cost savings associated with the use of DMPA-SC compared to DMPA-IM. Although DMPA-IM costs about $120 annually and DMPA-SC costs about $252 annually, this does not account for indirect costs such as supplies, overhead cost, nursing visits, and patient travel.6 Additionally, allowing patients to self-administer the DMPA-SC injection at home provides nurses time to care for other patients.

Moving forward, the PACT and gynecology teams will receive instruction on the importance of adhering to NFSGVHS procedures to ensure new patients prescribed DMPA-SC receive education and present for nursing appointments to ensure appropriate self-injection.

DMPA has historically been administered in the clinic setting by an HCP; therefore, the prescriber was available to assess adherence to therapy based on patient’s attendance to scheduled clinic appointments. Some prescribers may feel apprehensive about shifting the onus of medication adherence to the patient when prescribing DMPA-SC. However, this model is comparable to any other prescription form of birth control, such as combined hormonal contraceptive pills, where the prescriber expects the patient to take the medication as prescribed and refill their prescriptions in a timely manner to avoid gaps in therapy. The findings of this project suggest the majority of patients who were prescribed self-administered DMPA-SC for contraception were adherent to therapy. The utility of self-administration of DMPA-SC for other labeled or off-label indications was not evaluated; however, it is possible that patients who are motivated to self-administer the medication (regardless of indication) would also demonstrate similar adherence rates.

Conclusions

The majority of patients who started DMPA-SC tolerated the medication well and continued to refill therapy within the recommended time period. Patient self-administration of DMPA-SC can enhance access by removing barriers to administration, increase patient autonomy and contraceptive continuation rates. Overall, the increase in DMPA-SC prescriptions suggests that patients and HCPs support the option for DMPA-SC self-administration at NFSGVHS.

References
  1. Depo-SubQ Provera. Package insert. Pharmacia & Upjohn Co; 2019.
  2. Kaunitz AM. Depot medroxyprogesterone acetate. UpToDate. Updated June 12, 2025. Accessed July 11, 2025. https://www.uptodate.com/contents/depot-medroxyprogesterone-acetate-dmpa-formulations-patient-selection-and-drug-administration
  3. World Health Organization. WHO guideline on self-care interventions for health and well-being, 2022 revision. World Health Organization. 2022. Accessed July 17, 2025. https://iris.who.int/bitstream/handle/10665/357828/9789240052192-eng.pdf
  4. Kohn JE, Simons HR, Della Badia L, et al. Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood. Contraception. 2018;97(3):198-204. doi:10.1016/j.contraception.2017.11.009
  5. Kaunitz AM, Darney PD, Ross D, Wolter KD, Speroff L. Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density. Contraception. 2009;80(1):7-17. doi:10.1016/j.contraception.2009.02.005
  6. UpToDate, Lexidrug. Medroxyprogesterone acetate. Accessed July 16, 2025. https://online.lexi.com
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Correspondence: Jalaina Brown ([email protected])

Fed Pract. 2025;42(8). Published online August 15. doi:10.12788/fp.0614

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Fed Pract. 2025;42(8). Published online August 15. doi:10.12788/fp.0614

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Correspondence: Jalaina Brown ([email protected])

Fed Pract. 2025;42(8). Published online August 15. doi:10.12788/fp.0614

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Article PDF

Medroxyprogesterone acetate is an injectable medication indicated for contraception and management of endometriosis-associated pain in females of reproductive age.1 Medroxyprogesterone inhibits gonadotropin secretion, which prevents follicular maturation and ovulation. This leads to endometrial thinning and a contraceptive effect. Adverse drug reactions (ADRs), such as weight gain, menstrual bleeding irregularities, and bone loss appear to be dose- and time-related. Two formulations of medroxyprogesterone acetate are available: 150 mg depot medroxyprogesterone acetate intramuscular (DMPA-IM) and 104 mg DMPA subcutaneous (DMPA-SC).2 Originally, medroxyprogesterone acetate injections required administration by a health care worker. While the current labeling for DMPA-SC still indicates a requirement for administration by a health care worker, data show that the medication can be safe and effective when self-administered.3

Self-Administered Contraception

The 2019 World Health Organization (WHO) guideline on self-care interventions recommends making self-administered injectable contraception available to individuals of reproductive age.3 The WHO recommendation is based on evidence from the Depo Self-Administration Study, which included 401 patients randomized 1:1 to receive self-administered or clinic-administered DMPA-SC. This study concluded that self-administration improved continuation of contraception.4

The North Florida/South Georgia Veterans Health System (NFSGVHS) is the largest US Department of Veterans Affairs (VA) health care system, serving > 22,000 female veterans. All primary care practitioners (PCP) have been trained in women’s health (WH). 

The WH patient-aligned care team (PACT) clinical pharmacy practitioner (CPP) proposed using DMPA-SC for outpatient self-administration to increase access, improve patient satisfaction, and reduce burden on patients and nurses for administration appointments. The Pharmacy and Therapeutics Committee (P&T), WH Medical Director, and Chief of Gynecology approved the proposal. DMPA-SC was added to the ordering menu with order sets. The order set included instructions that outlined the 12-week dosing interval, instructions to contact the prescriber if the injection was > 2 weeks overdue (aligning with dosing recommendations for administration every 12 to 14 weeks), and an optional order for a home pregnancy test if necessary. These instructions were designed to ensure proper self-administration of the medication and timely follow-up care. 

The gynecology and PACT health care practitioners (HCPs), including physicians, pharmacists, nurses, and medical assistants, received DMPA-SC education, which consisted of a review of medication, ADRs, contraindications, and administration. An NFSGVHS procedure was developed to ensure patients received self-administration education. DMPA-SC prescriptions were mailed to patients with scheduled nursing appointments. The patient would then bring DMPA-SC to the nursing appointment where they received administration instruction and completed the first injection under nurse supervision to ensure appropriate technique. Patients were offered supplementary educational documents and a calendar to keep track of injection days. The patients were responsible for ordering refills and administering subsequent injections at home. Once all stakeholders received education and order sets were in place, prescribers and nurses could begin offering the option for initiation of self-administered DMPA-SC to patients. All conversions or new prescriptions were initiated by prescribers as a part of usual care.

Medication Use Evaluation

A medication use evaluation was conducted about 1 year after the rollout to assess use, adherence, and impact of DMPA-SC for patient-self administration as a new contraceptive option for NFSGVHS patients.

A retrospective chart review was conducted for patients dispensed DMPA-SC from June 1, 2022, to July 1, 2023. Baseline body mass index (BMI), recorded prior to initiation of DMPA-SC, was compared with the most recent BMI on record at the completion of the study to evaluate weight change. Nursing visit attendance for the first injection was also assessed. Adherence was evaluated by reviewing the date of the initial DMPA-SC prescription, the date of the patient's first nursing visit, and subsequent refill patterns. A 2-week margin of error was established to account for the flexibility within the recommended dosing interval and delays in postal service delivery.

Forty patients were initiated on DMPA-SC for patient self-administration. The mean age of patients was 37.2 years. All 40 patients were female. Twenty-two patients (55%) identified as Black, 17 (43%) as White, and 1 (3%) as Asian. The majority (90%) of patients were non-Hispanic. The mean baseline BMI was 30 and BMI after DMPA-SC initiation was 30.4.

Twenty-eight (70%) patients had a nursing appointment, adhering to the NFSGVHS protocol. Five patients (13%) discontinued use and switched to DMPA-IM administered by an HCP and 4 (10%) discontinued use following an ADR (hives, mood changes, bruising, and menometrorrhagia). Of the 31 patients who continued therapy, 25 (81%) were refilling appropriately (Table). 

FDP04208314_T

Six patients with unidentified reasons for nonadherence were contacted to determine if there were unmet contraceptive needs. This subgroup included patients with an active prescription for DMPA-SC that did not meet refill expectations. Nonadherence was mostly due to forgetfulness, however 1 patient was unable to refill her DMPA-SC in a timely manner due to an outside hospital admission and another was unreachable. These conversations were documented in the electronic health record (EHR) and all patients requesting follow-up, reinitiation of therapy, or alternative regimens, the appropriate parties were notified to coordinate care.

Discussion

The uptake in DMPA-SC prescribing suggests prescribers and patients have embraced self-administration as an option for contraception. Most patients were appropriately scheduled for nursing appointments to reinforce education and ensure appropriate self-injection technique, as outlined in the NFSGVHS procedure.

The need to improve adherence to NFSGVHS procedure was identified because not all patients had scheduled nursing appointments. This is concerning because some patients may have started self-injecting DMPA-SC without proper education, which could lead to improper injection technique and diminished effectiveness. Nursing appointments ensure appropriate self-injection techniques and reinforce the importance of refilling every 12 weeks for proper effectiveness. Nonadherence to contraceptive therapy may result in unintended pregnancy, although no pregnancies were reported by patients in this study. Pharmacist involvement in DMPA-SC initiation and follow-up monitoring may help ensure adherence to local procedure for initiation and improve patient adherence. 

There is limited evidence comparing weight gain related to DMPA-SC vs DMPA-IM. However, in a small, 2-year, randomized study, weight changes were considered comparable for both cohorts with a mean increase of 3.5 kg in the DMPA-IM group vs 3.4 kg in the DMPA-SC group.5 While our analysis did not formally evaluate weight changes, BMI data were collected to evaluate for evidence of weight change. The duration of therapy varied per patient and may not have been long enough to see comparable weight changes. 

Strengths of this project include the use of the PACT multidisciplinary approach in primary care including physicians, pharmacists, and nurses. The NFSGVHS EHR is comprehensive, and data including appointments and pharmacy refill information was readily available for collection and evaluation. Limitations included inconsistent documentation in the patient’s EHR which made collection of some data difficult.

Cost Estimates

NFSGVHS had 231 patients prescribed DMPA-IM at the time of DMPA-SC rollout and 40 patients initiated DMPA-SC therapy in the first year. There are possible cost savings associated with the use of DMPA-SC compared to DMPA-IM. Although DMPA-IM costs about $120 annually and DMPA-SC costs about $252 annually, this does not account for indirect costs such as supplies, overhead cost, nursing visits, and patient travel.6 Additionally, allowing patients to self-administer the DMPA-SC injection at home provides nurses time to care for other patients.

Moving forward, the PACT and gynecology teams will receive instruction on the importance of adhering to NFSGVHS procedures to ensure new patients prescribed DMPA-SC receive education and present for nursing appointments to ensure appropriate self-injection.

DMPA has historically been administered in the clinic setting by an HCP; therefore, the prescriber was available to assess adherence to therapy based on patient’s attendance to scheduled clinic appointments. Some prescribers may feel apprehensive about shifting the onus of medication adherence to the patient when prescribing DMPA-SC. However, this model is comparable to any other prescription form of birth control, such as combined hormonal contraceptive pills, where the prescriber expects the patient to take the medication as prescribed and refill their prescriptions in a timely manner to avoid gaps in therapy. The findings of this project suggest the majority of patients who were prescribed self-administered DMPA-SC for contraception were adherent to therapy. The utility of self-administration of DMPA-SC for other labeled or off-label indications was not evaluated; however, it is possible that patients who are motivated to self-administer the medication (regardless of indication) would also demonstrate similar adherence rates.

Conclusions

The majority of patients who started DMPA-SC tolerated the medication well and continued to refill therapy within the recommended time period. Patient self-administration of DMPA-SC can enhance access by removing barriers to administration, increase patient autonomy and contraceptive continuation rates. Overall, the increase in DMPA-SC prescriptions suggests that patients and HCPs support the option for DMPA-SC self-administration at NFSGVHS.

Medroxyprogesterone acetate is an injectable medication indicated for contraception and management of endometriosis-associated pain in females of reproductive age.1 Medroxyprogesterone inhibits gonadotropin secretion, which prevents follicular maturation and ovulation. This leads to endometrial thinning and a contraceptive effect. Adverse drug reactions (ADRs), such as weight gain, menstrual bleeding irregularities, and bone loss appear to be dose- and time-related. Two formulations of medroxyprogesterone acetate are available: 150 mg depot medroxyprogesterone acetate intramuscular (DMPA-IM) and 104 mg DMPA subcutaneous (DMPA-SC).2 Originally, medroxyprogesterone acetate injections required administration by a health care worker. While the current labeling for DMPA-SC still indicates a requirement for administration by a health care worker, data show that the medication can be safe and effective when self-administered.3

Self-Administered Contraception

The 2019 World Health Organization (WHO) guideline on self-care interventions recommends making self-administered injectable contraception available to individuals of reproductive age.3 The WHO recommendation is based on evidence from the Depo Self-Administration Study, which included 401 patients randomized 1:1 to receive self-administered or clinic-administered DMPA-SC. This study concluded that self-administration improved continuation of contraception.4

The North Florida/South Georgia Veterans Health System (NFSGVHS) is the largest US Department of Veterans Affairs (VA) health care system, serving > 22,000 female veterans. All primary care practitioners (PCP) have been trained in women’s health (WH). 

The WH patient-aligned care team (PACT) clinical pharmacy practitioner (CPP) proposed using DMPA-SC for outpatient self-administration to increase access, improve patient satisfaction, and reduce burden on patients and nurses for administration appointments. The Pharmacy and Therapeutics Committee (P&T), WH Medical Director, and Chief of Gynecology approved the proposal. DMPA-SC was added to the ordering menu with order sets. The order set included instructions that outlined the 12-week dosing interval, instructions to contact the prescriber if the injection was > 2 weeks overdue (aligning with dosing recommendations for administration every 12 to 14 weeks), and an optional order for a home pregnancy test if necessary. These instructions were designed to ensure proper self-administration of the medication and timely follow-up care. 

The gynecology and PACT health care practitioners (HCPs), including physicians, pharmacists, nurses, and medical assistants, received DMPA-SC education, which consisted of a review of medication, ADRs, contraindications, and administration. An NFSGVHS procedure was developed to ensure patients received self-administration education. DMPA-SC prescriptions were mailed to patients with scheduled nursing appointments. The patient would then bring DMPA-SC to the nursing appointment where they received administration instruction and completed the first injection under nurse supervision to ensure appropriate technique. Patients were offered supplementary educational documents and a calendar to keep track of injection days. The patients were responsible for ordering refills and administering subsequent injections at home. Once all stakeholders received education and order sets were in place, prescribers and nurses could begin offering the option for initiation of self-administered DMPA-SC to patients. All conversions or new prescriptions were initiated by prescribers as a part of usual care.

Medication Use Evaluation

A medication use evaluation was conducted about 1 year after the rollout to assess use, adherence, and impact of DMPA-SC for patient-self administration as a new contraceptive option for NFSGVHS patients.

A retrospective chart review was conducted for patients dispensed DMPA-SC from June 1, 2022, to July 1, 2023. Baseline body mass index (BMI), recorded prior to initiation of DMPA-SC, was compared with the most recent BMI on record at the completion of the study to evaluate weight change. Nursing visit attendance for the first injection was also assessed. Adherence was evaluated by reviewing the date of the initial DMPA-SC prescription, the date of the patient's first nursing visit, and subsequent refill patterns. A 2-week margin of error was established to account for the flexibility within the recommended dosing interval and delays in postal service delivery.

Forty patients were initiated on DMPA-SC for patient self-administration. The mean age of patients was 37.2 years. All 40 patients were female. Twenty-two patients (55%) identified as Black, 17 (43%) as White, and 1 (3%) as Asian. The majority (90%) of patients were non-Hispanic. The mean baseline BMI was 30 and BMI after DMPA-SC initiation was 30.4.

Twenty-eight (70%) patients had a nursing appointment, adhering to the NFSGVHS protocol. Five patients (13%) discontinued use and switched to DMPA-IM administered by an HCP and 4 (10%) discontinued use following an ADR (hives, mood changes, bruising, and menometrorrhagia). Of the 31 patients who continued therapy, 25 (81%) were refilling appropriately (Table). 

FDP04208314_T

Six patients with unidentified reasons for nonadherence were contacted to determine if there were unmet contraceptive needs. This subgroup included patients with an active prescription for DMPA-SC that did not meet refill expectations. Nonadherence was mostly due to forgetfulness, however 1 patient was unable to refill her DMPA-SC in a timely manner due to an outside hospital admission and another was unreachable. These conversations were documented in the electronic health record (EHR) and all patients requesting follow-up, reinitiation of therapy, or alternative regimens, the appropriate parties were notified to coordinate care.

Discussion

The uptake in DMPA-SC prescribing suggests prescribers and patients have embraced self-administration as an option for contraception. Most patients were appropriately scheduled for nursing appointments to reinforce education and ensure appropriate self-injection technique, as outlined in the NFSGVHS procedure.

The need to improve adherence to NFSGVHS procedure was identified because not all patients had scheduled nursing appointments. This is concerning because some patients may have started self-injecting DMPA-SC without proper education, which could lead to improper injection technique and diminished effectiveness. Nursing appointments ensure appropriate self-injection techniques and reinforce the importance of refilling every 12 weeks for proper effectiveness. Nonadherence to contraceptive therapy may result in unintended pregnancy, although no pregnancies were reported by patients in this study. Pharmacist involvement in DMPA-SC initiation and follow-up monitoring may help ensure adherence to local procedure for initiation and improve patient adherence. 

There is limited evidence comparing weight gain related to DMPA-SC vs DMPA-IM. However, in a small, 2-year, randomized study, weight changes were considered comparable for both cohorts with a mean increase of 3.5 kg in the DMPA-IM group vs 3.4 kg in the DMPA-SC group.5 While our analysis did not formally evaluate weight changes, BMI data were collected to evaluate for evidence of weight change. The duration of therapy varied per patient and may not have been long enough to see comparable weight changes. 

Strengths of this project include the use of the PACT multidisciplinary approach in primary care including physicians, pharmacists, and nurses. The NFSGVHS EHR is comprehensive, and data including appointments and pharmacy refill information was readily available for collection and evaluation. Limitations included inconsistent documentation in the patient’s EHR which made collection of some data difficult.

Cost Estimates

NFSGVHS had 231 patients prescribed DMPA-IM at the time of DMPA-SC rollout and 40 patients initiated DMPA-SC therapy in the first year. There are possible cost savings associated with the use of DMPA-SC compared to DMPA-IM. Although DMPA-IM costs about $120 annually and DMPA-SC costs about $252 annually, this does not account for indirect costs such as supplies, overhead cost, nursing visits, and patient travel.6 Additionally, allowing patients to self-administer the DMPA-SC injection at home provides nurses time to care for other patients.

Moving forward, the PACT and gynecology teams will receive instruction on the importance of adhering to NFSGVHS procedures to ensure new patients prescribed DMPA-SC receive education and present for nursing appointments to ensure appropriate self-injection.

DMPA has historically been administered in the clinic setting by an HCP; therefore, the prescriber was available to assess adherence to therapy based on patient’s attendance to scheduled clinic appointments. Some prescribers may feel apprehensive about shifting the onus of medication adherence to the patient when prescribing DMPA-SC. However, this model is comparable to any other prescription form of birth control, such as combined hormonal contraceptive pills, where the prescriber expects the patient to take the medication as prescribed and refill their prescriptions in a timely manner to avoid gaps in therapy. The findings of this project suggest the majority of patients who were prescribed self-administered DMPA-SC for contraception were adherent to therapy. The utility of self-administration of DMPA-SC for other labeled or off-label indications was not evaluated; however, it is possible that patients who are motivated to self-administer the medication (regardless of indication) would also demonstrate similar adherence rates.

Conclusions

The majority of patients who started DMPA-SC tolerated the medication well and continued to refill therapy within the recommended time period. Patient self-administration of DMPA-SC can enhance access by removing barriers to administration, increase patient autonomy and contraceptive continuation rates. Overall, the increase in DMPA-SC prescriptions suggests that patients and HCPs support the option for DMPA-SC self-administration at NFSGVHS.

References
  1. Depo-SubQ Provera. Package insert. Pharmacia & Upjohn Co; 2019.
  2. Kaunitz AM. Depot medroxyprogesterone acetate. UpToDate. Updated June 12, 2025. Accessed July 11, 2025. https://www.uptodate.com/contents/depot-medroxyprogesterone-acetate-dmpa-formulations-patient-selection-and-drug-administration
  3. World Health Organization. WHO guideline on self-care interventions for health and well-being, 2022 revision. World Health Organization. 2022. Accessed July 17, 2025. https://iris.who.int/bitstream/handle/10665/357828/9789240052192-eng.pdf
  4. Kohn JE, Simons HR, Della Badia L, et al. Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood. Contraception. 2018;97(3):198-204. doi:10.1016/j.contraception.2017.11.009
  5. Kaunitz AM, Darney PD, Ross D, Wolter KD, Speroff L. Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density. Contraception. 2009;80(1):7-17. doi:10.1016/j.contraception.2009.02.005
  6. UpToDate, Lexidrug. Medroxyprogesterone acetate. Accessed July 16, 2025. https://online.lexi.com
References
  1. Depo-SubQ Provera. Package insert. Pharmacia & Upjohn Co; 2019.
  2. Kaunitz AM. Depot medroxyprogesterone acetate. UpToDate. Updated June 12, 2025. Accessed July 11, 2025. https://www.uptodate.com/contents/depot-medroxyprogesterone-acetate-dmpa-formulations-patient-selection-and-drug-administration
  3. World Health Organization. WHO guideline on self-care interventions for health and well-being, 2022 revision. World Health Organization. 2022. Accessed July 17, 2025. https://iris.who.int/bitstream/handle/10665/357828/9789240052192-eng.pdf
  4. Kohn JE, Simons HR, Della Badia L, et al. Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood. Contraception. 2018;97(3):198-204. doi:10.1016/j.contraception.2017.11.009
  5. Kaunitz AM, Darney PD, Ross D, Wolter KD, Speroff L. Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density. Contraception. 2009;80(1):7-17. doi:10.1016/j.contraception.2009.02.005
  6. UpToDate, Lexidrug. Medroxyprogesterone acetate. Accessed July 16, 2025. https://online.lexi.com
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Proactive Penicillin Allergy Delabeling: Lessons Learned From a Quality Improvement Project

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Proactive Penicillin Allergy Delabeling: Lessons Learned From a Quality Improvement Project

Penicillin allergy is common in the United States. About 9.0% to 13.8% of patients have a diagnosed penicillin allergy documented in their electronic health record. The annual incidence rates is 1.1% in males and 1.4% in females.1,2

Penicillin hypersensitivity likely wanes over time. A 1981 study found that 93% of patients who experienced an allergic reaction to penicillin had a positive skin test 7 to 12 months postreaction, but only 22% still had a positive test after 10 years.3 Confirmed type 1 hypersensitivity penicillin allergies, as demonstrated by positive skin prick testing, also are decreasing over time.4 Furthermore, many patients’ reactions may have been misdiagnosed as a penicillin allergy. Upon actual confirmatory testing of penicillin allergy, only 8.5% to 13.8% of patients believed to have a penicillin allergy were positive on skin prick testing of penicillin products.5,6 A 2024 US study found that 11% of individuals with a history of a penicillin reaction tested positive on skin testing.7 

The positive predictive value of penicillin allergy skin testing is poorly defined due to the ethical dilemma of orally challenging a patient who demonstrates skin test reactivity. Due to its high negative predictive value (NPV), skin prick combined with intradermal testing has been the gold-standard test in cases of clinical concern.6 Patients with positive skin testing are assumed to be truly positive, and therefore penicillin allergic, even though false-positive results to penicillin skin testing are known to occur.8 

Misdiagnosis of penicillin allergy carries substantial clinical and economic consequences. A 2011 study suggested a statistically significant 1.8% increased absolute risk of mortality and 5.5% increased absolute risk of intensive care unit admission for those labeled with penicillin allergy and admitted for an infection.9 Another study found a 14% increase in mortality associated with the diagnosis of penicillin allergy.10 In a 2014 case-control study, penicillin allergy also was associated with a 23.4% greater risk of Clostridioides difficile, 14.1% more methicillin-resistant Staphylococcus aureus, and 30.1% more vancomycin-resistant enterococci infections.11Direct cost savings during an inpatient admission for infection were as much as $609 per patient with additional indirect cost savings of up to $4254 per admission.12 When viewed from the perspective of a health care system, these costs quickly accumulate, negatively impacting the fiscal stability of our patients and placing additional financial strain on an over-burdened system. 

If 10% of US patients have penicillin allergy labels, then about 33 million patients might be eligible for delabeling. There are only 6309 board-certified allergists actively practicing in the US, which could amount to about 5231 potential penicillin challenges per allergist, not even including the 3.3 million new patients per year (assuming a 1% incidence).13 Clarifying each patient’s tolerance of penicillin products will clearly require nonallergist cooperation.  

The 2022 drug allergy practice parameter update recommends several consensus-based statements (CBSs) to directly address penicillin allergy.14 This guideline recommends proactive efforts to delabel patients with a reported penicillin allergy (CBS 4); advise against testing in cases where the history is inconsistent with a true allergic reaction, though a challenge may be offered (CBS 5); skin testing for those with a history of anaphylaxis or a recent reaction (CBS 6); advise against multiple-day penicillin challenges (CBS 7); advise against skin testing for pediatric patients with benign cutaneous reactions (CBS 8); and recommends direct oral challenge for adults with distant or benign cutaneous reactions (CBS 9). These recommendations create a potentially high demand for delabeling with allergy specialists. One potential solution is to perform direct oral challenges in primary care, emergency departments, and urgent care clinics.  

Evidence supporting the safety of direct oral penicillin challenges in low-risk patients was initially noted in the allergy community, but now evidence for their use in primary care clinics is growing—including in children.15 In a military-specific population, an amoxicillin challenge of Marine recruits with suspected penicillin allergy revealed that only 1.5% of those challenged acutely reacted and should be considered allergic to penicillin.16 Historically, in order to refute the diagnosis of penicillin allergy, an allergist would order penicillin skin prick testing. If the test was negative, an allergist would proceed to intradermal testing and if negative again (NPV of 97.9%), proceed to a graded oral challenge.6 However, this process is not fully reproducible in most clinics because the minor determinants mixture used in skin testing is not commercially available.17 Additionally, the full skin testing procedure requires specialized training, is more time-consuming, causes more discomfort, lacks US Food and Drug Administration approval for children, and has a higher cost ($220 per test for each patient as of 2016).18 As such, the movement toward direct oral challenges is progressing. Nonetheless, the best method for primary care or emergency department clinicians to determine who the appropriate patients are for this procedure has not been fully established. Risk tools have been created in the past to help delineate low-risk patients who would be appropriate for direct oral amoxicillin challenges, but these were not widely replicated or validated.19 The PEN-FAST standardized risk score was first published in 2020 and has since been validated in different groups with additional safety data. This scoring system ranges from 0 to 5 points, assigning 2 points for a penicillin reaction within the past five (F) years, 2 points for angioedema/anaphylaxis (A) or a severe (S) cutaneous reaction, and 1 point if treatment (T) was required for the reaction. A score < 3 is considered low-risk and safe for direct oral challenge, although most of the safety data are in patients with a score of 0 or 1.20 The PEN-FAST guided direct oral challenge with an NPV of 96.3% has now been prospectively shown to be noninferior to standard skin prick test/intradermal test/graded challenge for low-risk patients with a PEN-FAST score < 3.21 The PEN-FAST validating study was conducted predominantly with an Australian population of adult White women, but now it also has been validated in children aged > 12 years, as well as in European and North American cohorts.22-24

Air Force Delabeling Program

This article describes a method for proactively, safely, and efficiently delabeling penicillin allergic patients at an Air Force clinic. This quality improvement (QI) report provides a successful model for penicillin allergy delabeling, illustrates lessons learned, and suggests next steps toward improving patient options for an invaluable antibiotic class.

The first step was to proactively delabel penicillin allergy from a population of active duty service members and their dependents. Electronic health record (EHR) allergy search functions are a helpful tool in finding patients with allergy labels. The Kadena Medical Clinic, in Okinawa, Japan, uses the Military Health System GENESIS EHR, which includes a discern reporting portal with a patient allergy search that creates a patient-specific medication allergy report. To compile the most complete database of patients with a penicillin allergy, all 15 potential allergy search options for “penicillin” were selected, as were 4 relevant options for amoxicillin (including options with clavulanate). Including so many options for specific penicillin medication allergies helps add specificity to the diagnosis in the EHR but can make aggregation of data more difficult. The report allowed all these specific medications to be selected at once for a particular clinic. However, the report did not populate patients with the allergy listed in other fields or free text.  

The complete compiled list was manually reviewed for high-risk patients with severe cutaneous adverse reactions (SCARs) of any age. Patients with pregnancy, unsuitable medical histories (ie, severe asthma), or taking β-blockers were excluded. Patients remaining on the list were contacted by telephone and offered appointments during a single week that was dedicated to penicillin allergy delabeling. Allergists in the Air Force are assigned to a region where they offer allergy services at clinics without a regular allergist. The allergist for the region traveled to the QI site for a 1-week campaign at an estimated cost of $4600. When the patients were contacted, they were briefly informed of the goal of the penicillin delabeling campaign, and if interested, they were scheduled for 1 of 50 available appointments that week. Patients were contacted with enough lead time to stop oral antihistamines (OAH) for ≥ 7 days before the appointment.  

Patients were given an intake questionnaire and interviewed about their penicillin allergy history. This questionnaire inquired about the nature of the allergy, mental and physical health impacts of the allergy label, PEN-FAST scoring questions, and posttest attitude toward delabeling, if applicable. Patients with a PEN-FAST score < 3 were offered direct, graded oral challenge or the standard skin prick, followed by intradermal, followed by graded oral challenge protocol. Patients with PEN-FAST scores of ≥ 3 were offered skin testing prior to oral challenge protocol. Patients could decline further testing. If patients wished to proceed, they were asked to complete a written informed consent document.  

Oral challenges followed a 10%/90% protocol, beginning with 50 mg of liquid amoxicillin followed by 450 mg after 15 minutes, as long as the patient remained asymptomatic. Challenge forms are available in the eAppendix . After receiving the 450-mg amoxicillin dose, the patient remained in the clinic for 60 minutes before a final clinical evaluation. If the patient remained asymptomatic after this period, the penicillin or amoxicillin allergy was marked as resolved in the EHR. The patients were given contact information for the clinic for follow-up if a delayed reaction was noted and they wished the medication allergy to be re-entered. An EHR encounter note was created for each patient detailing the allergy testing and delabeling.  

FDP04208308_eA

This campaign was conducted at a basic life support-only facility by a single clinician without medical technician support. An allergic reaction medication kit was available and contained OAHs, intramuscular antihistamines, intramuscular epinephrine, intramuscular corticosteroids, and short-acting β-agonists for nebulization. The facility also had an urgent care room (staffed by primary care practitioners [PCPs]) that could help establish intravenous access and administer fluids if necessary and had previously established plans for emergency patient transport to a higher level of care, if necessary.

Program Outcomes

A list of 65 patients that included both active-duty service members and dependents with penicillin or amoxicillin allergy was created. This list was reviewed by an allergist to identify high-risk individuals, which required about 90 minutes. Two patients (3%) were excluded; 1 had a history of SCAR to penicillin and 1 had a complex medical history requiring continued OAH use. Sixty-three patients were contacted via telephone, and 29 patients (46%) scheduled an appointment. One patient (2%) was identified as penicillin-tolerant during the booking process, and the penicillin allergy was removed without testing (Figure 1).

FDP04208308_F1

Of the 29 scheduled patients, 5 patients (17%) failed to present for care. Of the potential appointments set aside for the program, only 42% were used. One patient (4%) who was seen in clinic was delabeled based on history alone as they had previously successfully tolerated a course of amoxicillin. Four patients (17%) declined further testing with a PEN-FAST score > 2 due to a clear history of acute immunoglobulin (Ig) E-mediated reaction to a penicillin product within the past year. One patient (4%) was unable to be tested due to ongoing OAH use and 1 patient (4%) declined further penicillin testing after the discussion about risks, benefits, and alternatives to the procedures offered.  

Of the 24 patients who arrived for a clinic appointment, 17 (71%) underwent penicillin allergy delabeling testing: 14 (82%) underwent direct challenge, and 3 (18%) underwent the skin testing before oral amoxicillin challenge procedure. Of the 17 who were tested, 16 (94%) tolerated a total dose of 500 mg of oral amoxicillin within the 1-hour observation period. One tested patient (6%) in the direct oral challenge group experienced an adverse reaction that was described as dull headache and hand tremor after the 50-mg dose; although it self-resolved within 15 minutes, this prompted the patient to discontinue the challenge. This adverse reaction was determined to be very unlikely IgE-mediated. None of the 3 patients who underwent the skin testing before oral challenge protocol experienced an adverse drug reaction (ADR). None of the 17 patients who received any oral amoxicillin required follow-up or reported a delayed cutaneous ADR to the challenge. No OAHs or epinephrine were used for any of the challenges. 

Data collected from patient questionnaires displayed perceived health impacts of a penicillin allergy on the patient population. Patients reported a variety of ADRs to previous administration of penicillin products: 17 (71%) reported urticaria, 2 (8%) reported anaphylaxis, and 3 (13%) were unable to recall the reaction (Figure 2). Nine patients (38%) felt their initial reaction was distressing. Fifteen patients (88%) felt relief following negative testing (Table).

FDP04208308_F2FDP04208308_T

Discussion

To our knowledge, this was the first documented proactive penicillin delabeling QI project in a military clinic treating both active-duty service members and their dependents, modeled on the 2022 drug allergy guidelines.14 Several interesting lessons were learned that may improve future similar QI projects. Only 46% of patients identified as having penicillin allergy presented for evaluation, leaving 42% of available appointments unused. Without prior data on anticipated participation rates, these data provide a crude benchmark for utilization rates, which can inform future resource planning. While attempts were made to contact each patient, additional efforts to publicize the penicillin allergy delabeling campaign would have been useful to improve efficiency.

In addition, when patients with a PEN-FAST score of < 3 were educated about the risks and benefits of each procedure and offered the direct oral graded challenge and skin testing prior to oral challenge, 82% preferred the direct challenge. None of the patients who experienced a penicillin ADR in the past year wished to undergo skin testing or oral challenge, though each was educated on penicillin allergy and the possibility of testing in the future, making each encounter beneficial. Of the 17 patients tested, 16 (94%) tolerated oral amoxicillin and 1 (6%) experienced a mild, self-resolving ADR that was very unlikely of an IgE-mediated origin. Additionally, while plans and preparations for ADRs to the challenges were available, none were required. Patient questionnaires demonstrated the heterogeneity of previous ADRs and their attitude toward their allergy diagnosis. The positive impact of delabeling on patient well-being noted by 88% of patients reinforced the benefit of the effort.  

This project was limited by a relatively small sample size, which may not have been large enough to detect ADRs, especially IgE-mediated allergic reactions. Herein lies the importance of having clinicians equipped to treat allergic ADRs to conduct penicillin challenges in the primary care setting. It is prudent to ensure not only proper training of physicians performing these challenges, but also appropriate equipment, medication, and response personnel. Medications that are useful include epinephrine, OAHs, albuterol, steroids, and intravenous fluids.  

Having a response area and plan are essential to ensure appropriate care in the rare instance of allergic ADRs progressing to anaphylaxis. In rare cases, emergency medical services may be required and having a plan with appropriate response and transport time is essential to patient safety. This may not be practical in more rural or smaller practices. In those scenarios, it may be helpful to partner with a larger practice to send patients for delabeling or to use clinical space in closer proximity to emergency services. Perhaps an ideal setting might be urgent or emergent care centers due to high acuity resources and frequent prescription of amoxicillin antibiotics; however, this may be complicated by concurrent infections raising the incidence of delayed benign eruptions with amoxicillin ingestion and complicating the patient’s allergy records. Further training of urgent and emergent care practitioners would be helpful for proper patient education regarding antibiotic-associated reactions.  

Full testing integration into other primary care clinics may be limited due to the specialized training required for complete skin testing. Nevertheless, as shown in this project, most patients may be delabeled based on a PEN-FAST evaluation followed by oral challenge alone. Incorporation in other QI projects could involve continuing medical education to train staff physicians on PEN-FAST, teaching primary care residents during training, and site visits by allergists to train local physicians on testing. This project involved training 2 PCPs to conduct skin and oral challenge testing using PEN-FAST to guide clinical decision-making with an allergist available for consultation if needed. Future projects might model a similar approach or perhaps focus on training more physicians on oral challenges alone to reach a high percentage of the target population.

Conclusions

This project demonstrates a safe, efficient, and cost-effective model for penicillin allergy delabeling in clinics without regular access to allergy services. The use of PEN-FAST allows a quick and simple method to screen patients with penicillin allergy to meet the goals of the 2022 CBSs, but data are still accumulating to validate this method of screening across populations. This project demonstrates additional support for the use of PEN-FAST, while illustrating appropriate education regarding oral testing technique and its limitations.

Using an EHR report limited the patients in the testing pool and subsequent sample size. This suggests that a primary care identification-driven enrollment in testing may offer even more benefit both in allergy detection and education of testing benefits. Oral challenges are more cost effective, shorter in duration, and have fewer training requirements when compared with antecedent skin testing, making them an ideal option for PCPs in a clinic setting. Trained PCPs may opt to offer periodic appointments for delabeling, or offer days dedicated to delabeling as many patients as possible. Penicillin delabeling is an urgent and expansive charge; this study offers a replicable model for executing this important task.

References
  1. Macy E, Poon KYT. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009;122(8):778.e1-778.e7787. doi:10.1016/j.amjmed.2009.01.034
  2. Zhou L, Dhopeshwarkar N, Blumenthal KG, et al. Drug allergies documented in electronic health records of a large healthcare system. Allergy. 2016;71(9):1305-1313. doi:10.1111/all.12881
  3. Sullivan TJ, Wedner HJ, Shatz GS, Yecies LD, Parker CW. Skin testing to detect penicillin allergy. J Allergy Clin Immunol. 1981;68(3):171-180. doi:10.1016/0091-6749(81)90180-9
  4. Macy E, Schatz M, Lin C, Poon KY. The falling rate of positive penicillin skin tests from 1995 to 2007. Perm J. 2009;13(2):12-18. doi:10.7812/TPP/08-073
  5. Fox SJ, Park MA. Penicillin skin testing is a safe and effective tool for evaluating penicillin allergy in the pediatric population. J Allergy Clin Immunol Pract. 2014;2(4):439-444. doi:10.1016/j.jaip.2014.04.013
  6. Solensky R, Jacobs J, Lester M, et al. Penicillin Allergy Evaluation: A Prospective, Multicenter, Open-Label Evaluation of a Comprehensive Penicillin Skin Test Kit. J Allergy Clin Immunol Pract. 2019;7(6):1876-1885.e3. doi:10.1016/j.jaip.2019.02.040 7. 
  7. Gonzalez-Estrada A, Park MA, Accarino JJO, et al. Predicting penicillin allergy: A United States multicenter retrospective study. J Allergy Clin Immunol Pract. 2024;12(5):1181-1191.e10. doi:10.1016/j.jaip.2024.01.010
  8. Stüwe HT, Geissler W, Paap A, Cromwell O. The presence of latex can induce false-positive skin tests in subjects tested with penicillin determinants. Allergy. 1997;52(12):1243. doi:10.1111/j.1398-9995.1997.tb00975.x
  9. Charneski L, Deshpande G, Smith SW. Impact of an antimicrobial allergy label in the medical record on clinical outcomes in hospitalized patients. Pharmacotherapy. 2011;31(8):742-747. doi:10.1592/phco.31.8.742
  10. Blumenthal KG, Lu N, Zhang Y, Walensky RP, Choi HK. Recorded penicillin allergy and risk of mortality: a population-based matched cohort study. J Gen Intern Med. 2019;34(9):1685-1687. doi:10.1007/s11606-019-04991-y
  11. Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin “allergy” in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014;133(3):790-796. doi:10.1016/j.jaci.2013.09.021
  12. Mattingly TJ II, Fulton A, Lumish RA, et al. The cost of self-reported penicillin allergy: a systematic review. J Allergy Clin Immunol Pract. 2018;6(5):1649-1654.e4. doi:10.1016/j.jaip.2017.12.033
  13. Diplomate Statistics. American Board of Allergy and Immunology website. Published February, 18 2021. Accessed July 28, 2025. https://www.abai.org/statistics_diplomates.asp
  14. Khan DA, Banerji A, Blumenthal KG, et al. Drug allergy: a 2022 practice parameter update. J Allergy Clin Immunol. 2022;150(6):1333-1393. doi:10.1016/j.jaci.2022.08.028 
  15. Mill C, Primeau MN, Medoff E, et al. Assessing the diagnostic properties of a graded oral provocation challenge for the diagnosis of immediate and nonimmediate reactions to amoxicillin in children. JAMA Pediatr. 2016;170:e160033. doi:10.1001/jamapediatrics.2016.0033
  16. Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017;5(3):813-815. doi:10.1016/j.jaip.2017.01.023
  17. Shenoy ES, Macy E, Rowe T, Blumenthal KG. Evaluation and management of penicillin allergy: a review. JAMA. 2019;321(2):188–99. doi:10.1001/jama.2018.19283
  18. Blumenthal KG, Li Y, Banerji A, et al. The cost of penicillin allergy evaluation. J Allergy Clin Immunol Pract. 2018;6(3):1019-1027.e2. doi:10.1016/j.jaip.2017.08.006
  19. Banks TA, Tucker M, Macy E. Evaluating penicillin allergies without skin testing. Curr Allergy Asthma Rep. 2019;19(5):27. doi:10.1007/s11882-019-0854-6
  20. Trubiano JA, Vogrin S, Chua KYL, et al. Development and validation of a penicillin allergy clinical decision rule. JAMA Intern Med. 2020;180(5):745-752. doi:10.1001/jamainternmed.2020.0403
  21. Copaescu AM, Vogrin S, James F, et al. Efficacy of a clinical decision rule to enable direct oral challenge in patients with low-risk penicillin allergy: the PALACE randomized clinical trial. JAMA Intern Med. 2023;183(9):944-952. doi:10.1001/jamainternmed.2023.2986
  22. Copaescu AM, Vogrin S, Shand G, et al. Validation of the PEN-FAST score in a pediatric population. JAMA Netw Open. 2022;5(9):e2233703. doi:10.1001/jamanetworkopen.2022.33703
  23. Piotin A, Godet J, Trubiano JA, et al. Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. Ann Allergy Asthma Immunol. 2022;128(1):27-32. doi:10.1016/j.anai.2021.07.005
  24. Su C, Belmont A, Liao J, et al. Evaluating the PEN-FAST clinical decision-making tool to enhance penicillin allergy delabeling. JAMA Intern Med. 2023;183(8):883-885. doi:10.1001/jamainternmed.2023.1572
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b673rd Medical Group, Joint Base Elmendorf-Richardson, Alaska

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The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Sarah McDonald ([email protected])

Fed Pract. 2025;42(8). Published online August 17. doi:10.12788/fp.0611

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The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Sarah McDonald ([email protected])

Fed Pract. 2025;42(8). Published online August 17. doi:10.12788/fp.0611

Author and Disclosure Information

Maj Sarah McDonald, MD, MC USAFa; Lt Col Derek Smith, MD, MC USAFb

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Correspondence: Sarah McDonald ([email protected])

Fed Pract. 2025;42(8). Published online August 17. doi:10.12788/fp.0611

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Article PDF

Penicillin allergy is common in the United States. About 9.0% to 13.8% of patients have a diagnosed penicillin allergy documented in their electronic health record. The annual incidence rates is 1.1% in males and 1.4% in females.1,2

Penicillin hypersensitivity likely wanes over time. A 1981 study found that 93% of patients who experienced an allergic reaction to penicillin had a positive skin test 7 to 12 months postreaction, but only 22% still had a positive test after 10 years.3 Confirmed type 1 hypersensitivity penicillin allergies, as demonstrated by positive skin prick testing, also are decreasing over time.4 Furthermore, many patients’ reactions may have been misdiagnosed as a penicillin allergy. Upon actual confirmatory testing of penicillin allergy, only 8.5% to 13.8% of patients believed to have a penicillin allergy were positive on skin prick testing of penicillin products.5,6 A 2024 US study found that 11% of individuals with a history of a penicillin reaction tested positive on skin testing.7 

The positive predictive value of penicillin allergy skin testing is poorly defined due to the ethical dilemma of orally challenging a patient who demonstrates skin test reactivity. Due to its high negative predictive value (NPV), skin prick combined with intradermal testing has been the gold-standard test in cases of clinical concern.6 Patients with positive skin testing are assumed to be truly positive, and therefore penicillin allergic, even though false-positive results to penicillin skin testing are known to occur.8 

Misdiagnosis of penicillin allergy carries substantial clinical and economic consequences. A 2011 study suggested a statistically significant 1.8% increased absolute risk of mortality and 5.5% increased absolute risk of intensive care unit admission for those labeled with penicillin allergy and admitted for an infection.9 Another study found a 14% increase in mortality associated with the diagnosis of penicillin allergy.10 In a 2014 case-control study, penicillin allergy also was associated with a 23.4% greater risk of Clostridioides difficile, 14.1% more methicillin-resistant Staphylococcus aureus, and 30.1% more vancomycin-resistant enterococci infections.11Direct cost savings during an inpatient admission for infection were as much as $609 per patient with additional indirect cost savings of up to $4254 per admission.12 When viewed from the perspective of a health care system, these costs quickly accumulate, negatively impacting the fiscal stability of our patients and placing additional financial strain on an over-burdened system. 

If 10% of US patients have penicillin allergy labels, then about 33 million patients might be eligible for delabeling. There are only 6309 board-certified allergists actively practicing in the US, which could amount to about 5231 potential penicillin challenges per allergist, not even including the 3.3 million new patients per year (assuming a 1% incidence).13 Clarifying each patient’s tolerance of penicillin products will clearly require nonallergist cooperation.  

The 2022 drug allergy practice parameter update recommends several consensus-based statements (CBSs) to directly address penicillin allergy.14 This guideline recommends proactive efforts to delabel patients with a reported penicillin allergy (CBS 4); advise against testing in cases where the history is inconsistent with a true allergic reaction, though a challenge may be offered (CBS 5); skin testing for those with a history of anaphylaxis or a recent reaction (CBS 6); advise against multiple-day penicillin challenges (CBS 7); advise against skin testing for pediatric patients with benign cutaneous reactions (CBS 8); and recommends direct oral challenge for adults with distant or benign cutaneous reactions (CBS 9). These recommendations create a potentially high demand for delabeling with allergy specialists. One potential solution is to perform direct oral challenges in primary care, emergency departments, and urgent care clinics.  

Evidence supporting the safety of direct oral penicillin challenges in low-risk patients was initially noted in the allergy community, but now evidence for their use in primary care clinics is growing—including in children.15 In a military-specific population, an amoxicillin challenge of Marine recruits with suspected penicillin allergy revealed that only 1.5% of those challenged acutely reacted and should be considered allergic to penicillin.16 Historically, in order to refute the diagnosis of penicillin allergy, an allergist would order penicillin skin prick testing. If the test was negative, an allergist would proceed to intradermal testing and if negative again (NPV of 97.9%), proceed to a graded oral challenge.6 However, this process is not fully reproducible in most clinics because the minor determinants mixture used in skin testing is not commercially available.17 Additionally, the full skin testing procedure requires specialized training, is more time-consuming, causes more discomfort, lacks US Food and Drug Administration approval for children, and has a higher cost ($220 per test for each patient as of 2016).18 As such, the movement toward direct oral challenges is progressing. Nonetheless, the best method for primary care or emergency department clinicians to determine who the appropriate patients are for this procedure has not been fully established. Risk tools have been created in the past to help delineate low-risk patients who would be appropriate for direct oral amoxicillin challenges, but these were not widely replicated or validated.19 The PEN-FAST standardized risk score was first published in 2020 and has since been validated in different groups with additional safety data. This scoring system ranges from 0 to 5 points, assigning 2 points for a penicillin reaction within the past five (F) years, 2 points for angioedema/anaphylaxis (A) or a severe (S) cutaneous reaction, and 1 point if treatment (T) was required for the reaction. A score < 3 is considered low-risk and safe for direct oral challenge, although most of the safety data are in patients with a score of 0 or 1.20 The PEN-FAST guided direct oral challenge with an NPV of 96.3% has now been prospectively shown to be noninferior to standard skin prick test/intradermal test/graded challenge for low-risk patients with a PEN-FAST score < 3.21 The PEN-FAST validating study was conducted predominantly with an Australian population of adult White women, but now it also has been validated in children aged > 12 years, as well as in European and North American cohorts.22-24

Air Force Delabeling Program

This article describes a method for proactively, safely, and efficiently delabeling penicillin allergic patients at an Air Force clinic. This quality improvement (QI) report provides a successful model for penicillin allergy delabeling, illustrates lessons learned, and suggests next steps toward improving patient options for an invaluable antibiotic class.

The first step was to proactively delabel penicillin allergy from a population of active duty service members and their dependents. Electronic health record (EHR) allergy search functions are a helpful tool in finding patients with allergy labels. The Kadena Medical Clinic, in Okinawa, Japan, uses the Military Health System GENESIS EHR, which includes a discern reporting portal with a patient allergy search that creates a patient-specific medication allergy report. To compile the most complete database of patients with a penicillin allergy, all 15 potential allergy search options for “penicillin” were selected, as were 4 relevant options for amoxicillin (including options with clavulanate). Including so many options for specific penicillin medication allergies helps add specificity to the diagnosis in the EHR but can make aggregation of data more difficult. The report allowed all these specific medications to be selected at once for a particular clinic. However, the report did not populate patients with the allergy listed in other fields or free text.  

The complete compiled list was manually reviewed for high-risk patients with severe cutaneous adverse reactions (SCARs) of any age. Patients with pregnancy, unsuitable medical histories (ie, severe asthma), or taking β-blockers were excluded. Patients remaining on the list were contacted by telephone and offered appointments during a single week that was dedicated to penicillin allergy delabeling. Allergists in the Air Force are assigned to a region where they offer allergy services at clinics without a regular allergist. The allergist for the region traveled to the QI site for a 1-week campaign at an estimated cost of $4600. When the patients were contacted, they were briefly informed of the goal of the penicillin delabeling campaign, and if interested, they were scheduled for 1 of 50 available appointments that week. Patients were contacted with enough lead time to stop oral antihistamines (OAH) for ≥ 7 days before the appointment.  

Patients were given an intake questionnaire and interviewed about their penicillin allergy history. This questionnaire inquired about the nature of the allergy, mental and physical health impacts of the allergy label, PEN-FAST scoring questions, and posttest attitude toward delabeling, if applicable. Patients with a PEN-FAST score < 3 were offered direct, graded oral challenge or the standard skin prick, followed by intradermal, followed by graded oral challenge protocol. Patients with PEN-FAST scores of ≥ 3 were offered skin testing prior to oral challenge protocol. Patients could decline further testing. If patients wished to proceed, they were asked to complete a written informed consent document.  

Oral challenges followed a 10%/90% protocol, beginning with 50 mg of liquid amoxicillin followed by 450 mg after 15 minutes, as long as the patient remained asymptomatic. Challenge forms are available in the eAppendix . After receiving the 450-mg amoxicillin dose, the patient remained in the clinic for 60 minutes before a final clinical evaluation. If the patient remained asymptomatic after this period, the penicillin or amoxicillin allergy was marked as resolved in the EHR. The patients were given contact information for the clinic for follow-up if a delayed reaction was noted and they wished the medication allergy to be re-entered. An EHR encounter note was created for each patient detailing the allergy testing and delabeling.  

FDP04208308_eA

This campaign was conducted at a basic life support-only facility by a single clinician without medical technician support. An allergic reaction medication kit was available and contained OAHs, intramuscular antihistamines, intramuscular epinephrine, intramuscular corticosteroids, and short-acting β-agonists for nebulization. The facility also had an urgent care room (staffed by primary care practitioners [PCPs]) that could help establish intravenous access and administer fluids if necessary and had previously established plans for emergency patient transport to a higher level of care, if necessary.

Program Outcomes

A list of 65 patients that included both active-duty service members and dependents with penicillin or amoxicillin allergy was created. This list was reviewed by an allergist to identify high-risk individuals, which required about 90 minutes. Two patients (3%) were excluded; 1 had a history of SCAR to penicillin and 1 had a complex medical history requiring continued OAH use. Sixty-three patients were contacted via telephone, and 29 patients (46%) scheduled an appointment. One patient (2%) was identified as penicillin-tolerant during the booking process, and the penicillin allergy was removed without testing (Figure 1).

FDP04208308_F1

Of the 29 scheduled patients, 5 patients (17%) failed to present for care. Of the potential appointments set aside for the program, only 42% were used. One patient (4%) who was seen in clinic was delabeled based on history alone as they had previously successfully tolerated a course of amoxicillin. Four patients (17%) declined further testing with a PEN-FAST score > 2 due to a clear history of acute immunoglobulin (Ig) E-mediated reaction to a penicillin product within the past year. One patient (4%) was unable to be tested due to ongoing OAH use and 1 patient (4%) declined further penicillin testing after the discussion about risks, benefits, and alternatives to the procedures offered.  

Of the 24 patients who arrived for a clinic appointment, 17 (71%) underwent penicillin allergy delabeling testing: 14 (82%) underwent direct challenge, and 3 (18%) underwent the skin testing before oral amoxicillin challenge procedure. Of the 17 who were tested, 16 (94%) tolerated a total dose of 500 mg of oral amoxicillin within the 1-hour observation period. One tested patient (6%) in the direct oral challenge group experienced an adverse reaction that was described as dull headache and hand tremor after the 50-mg dose; although it self-resolved within 15 minutes, this prompted the patient to discontinue the challenge. This adverse reaction was determined to be very unlikely IgE-mediated. None of the 3 patients who underwent the skin testing before oral challenge protocol experienced an adverse drug reaction (ADR). None of the 17 patients who received any oral amoxicillin required follow-up or reported a delayed cutaneous ADR to the challenge. No OAHs or epinephrine were used for any of the challenges. 

Data collected from patient questionnaires displayed perceived health impacts of a penicillin allergy on the patient population. Patients reported a variety of ADRs to previous administration of penicillin products: 17 (71%) reported urticaria, 2 (8%) reported anaphylaxis, and 3 (13%) were unable to recall the reaction (Figure 2). Nine patients (38%) felt their initial reaction was distressing. Fifteen patients (88%) felt relief following negative testing (Table).

FDP04208308_F2FDP04208308_T

Discussion

To our knowledge, this was the first documented proactive penicillin delabeling QI project in a military clinic treating both active-duty service members and their dependents, modeled on the 2022 drug allergy guidelines.14 Several interesting lessons were learned that may improve future similar QI projects. Only 46% of patients identified as having penicillin allergy presented for evaluation, leaving 42% of available appointments unused. Without prior data on anticipated participation rates, these data provide a crude benchmark for utilization rates, which can inform future resource planning. While attempts were made to contact each patient, additional efforts to publicize the penicillin allergy delabeling campaign would have been useful to improve efficiency.

In addition, when patients with a PEN-FAST score of < 3 were educated about the risks and benefits of each procedure and offered the direct oral graded challenge and skin testing prior to oral challenge, 82% preferred the direct challenge. None of the patients who experienced a penicillin ADR in the past year wished to undergo skin testing or oral challenge, though each was educated on penicillin allergy and the possibility of testing in the future, making each encounter beneficial. Of the 17 patients tested, 16 (94%) tolerated oral amoxicillin and 1 (6%) experienced a mild, self-resolving ADR that was very unlikely of an IgE-mediated origin. Additionally, while plans and preparations for ADRs to the challenges were available, none were required. Patient questionnaires demonstrated the heterogeneity of previous ADRs and their attitude toward their allergy diagnosis. The positive impact of delabeling on patient well-being noted by 88% of patients reinforced the benefit of the effort.  

This project was limited by a relatively small sample size, which may not have been large enough to detect ADRs, especially IgE-mediated allergic reactions. Herein lies the importance of having clinicians equipped to treat allergic ADRs to conduct penicillin challenges in the primary care setting. It is prudent to ensure not only proper training of physicians performing these challenges, but also appropriate equipment, medication, and response personnel. Medications that are useful include epinephrine, OAHs, albuterol, steroids, and intravenous fluids.  

Having a response area and plan are essential to ensure appropriate care in the rare instance of allergic ADRs progressing to anaphylaxis. In rare cases, emergency medical services may be required and having a plan with appropriate response and transport time is essential to patient safety. This may not be practical in more rural or smaller practices. In those scenarios, it may be helpful to partner with a larger practice to send patients for delabeling or to use clinical space in closer proximity to emergency services. Perhaps an ideal setting might be urgent or emergent care centers due to high acuity resources and frequent prescription of amoxicillin antibiotics; however, this may be complicated by concurrent infections raising the incidence of delayed benign eruptions with amoxicillin ingestion and complicating the patient’s allergy records. Further training of urgent and emergent care practitioners would be helpful for proper patient education regarding antibiotic-associated reactions.  

Full testing integration into other primary care clinics may be limited due to the specialized training required for complete skin testing. Nevertheless, as shown in this project, most patients may be delabeled based on a PEN-FAST evaluation followed by oral challenge alone. Incorporation in other QI projects could involve continuing medical education to train staff physicians on PEN-FAST, teaching primary care residents during training, and site visits by allergists to train local physicians on testing. This project involved training 2 PCPs to conduct skin and oral challenge testing using PEN-FAST to guide clinical decision-making with an allergist available for consultation if needed. Future projects might model a similar approach or perhaps focus on training more physicians on oral challenges alone to reach a high percentage of the target population.

Conclusions

This project demonstrates a safe, efficient, and cost-effective model for penicillin allergy delabeling in clinics without regular access to allergy services. The use of PEN-FAST allows a quick and simple method to screen patients with penicillin allergy to meet the goals of the 2022 CBSs, but data are still accumulating to validate this method of screening across populations. This project demonstrates additional support for the use of PEN-FAST, while illustrating appropriate education regarding oral testing technique and its limitations.

Using an EHR report limited the patients in the testing pool and subsequent sample size. This suggests that a primary care identification-driven enrollment in testing may offer even more benefit both in allergy detection and education of testing benefits. Oral challenges are more cost effective, shorter in duration, and have fewer training requirements when compared with antecedent skin testing, making them an ideal option for PCPs in a clinic setting. Trained PCPs may opt to offer periodic appointments for delabeling, or offer days dedicated to delabeling as many patients as possible. Penicillin delabeling is an urgent and expansive charge; this study offers a replicable model for executing this important task.

Penicillin allergy is common in the United States. About 9.0% to 13.8% of patients have a diagnosed penicillin allergy documented in their electronic health record. The annual incidence rates is 1.1% in males and 1.4% in females.1,2

Penicillin hypersensitivity likely wanes over time. A 1981 study found that 93% of patients who experienced an allergic reaction to penicillin had a positive skin test 7 to 12 months postreaction, but only 22% still had a positive test after 10 years.3 Confirmed type 1 hypersensitivity penicillin allergies, as demonstrated by positive skin prick testing, also are decreasing over time.4 Furthermore, many patients’ reactions may have been misdiagnosed as a penicillin allergy. Upon actual confirmatory testing of penicillin allergy, only 8.5% to 13.8% of patients believed to have a penicillin allergy were positive on skin prick testing of penicillin products.5,6 A 2024 US study found that 11% of individuals with a history of a penicillin reaction tested positive on skin testing.7 

The positive predictive value of penicillin allergy skin testing is poorly defined due to the ethical dilemma of orally challenging a patient who demonstrates skin test reactivity. Due to its high negative predictive value (NPV), skin prick combined with intradermal testing has been the gold-standard test in cases of clinical concern.6 Patients with positive skin testing are assumed to be truly positive, and therefore penicillin allergic, even though false-positive results to penicillin skin testing are known to occur.8 

Misdiagnosis of penicillin allergy carries substantial clinical and economic consequences. A 2011 study suggested a statistically significant 1.8% increased absolute risk of mortality and 5.5% increased absolute risk of intensive care unit admission for those labeled with penicillin allergy and admitted for an infection.9 Another study found a 14% increase in mortality associated with the diagnosis of penicillin allergy.10 In a 2014 case-control study, penicillin allergy also was associated with a 23.4% greater risk of Clostridioides difficile, 14.1% more methicillin-resistant Staphylococcus aureus, and 30.1% more vancomycin-resistant enterococci infections.11Direct cost savings during an inpatient admission for infection were as much as $609 per patient with additional indirect cost savings of up to $4254 per admission.12 When viewed from the perspective of a health care system, these costs quickly accumulate, negatively impacting the fiscal stability of our patients and placing additional financial strain on an over-burdened system. 

If 10% of US patients have penicillin allergy labels, then about 33 million patients might be eligible for delabeling. There are only 6309 board-certified allergists actively practicing in the US, which could amount to about 5231 potential penicillin challenges per allergist, not even including the 3.3 million new patients per year (assuming a 1% incidence).13 Clarifying each patient’s tolerance of penicillin products will clearly require nonallergist cooperation.  

The 2022 drug allergy practice parameter update recommends several consensus-based statements (CBSs) to directly address penicillin allergy.14 This guideline recommends proactive efforts to delabel patients with a reported penicillin allergy (CBS 4); advise against testing in cases where the history is inconsistent with a true allergic reaction, though a challenge may be offered (CBS 5); skin testing for those with a history of anaphylaxis or a recent reaction (CBS 6); advise against multiple-day penicillin challenges (CBS 7); advise against skin testing for pediatric patients with benign cutaneous reactions (CBS 8); and recommends direct oral challenge for adults with distant or benign cutaneous reactions (CBS 9). These recommendations create a potentially high demand for delabeling with allergy specialists. One potential solution is to perform direct oral challenges in primary care, emergency departments, and urgent care clinics.  

Evidence supporting the safety of direct oral penicillin challenges in low-risk patients was initially noted in the allergy community, but now evidence for their use in primary care clinics is growing—including in children.15 In a military-specific population, an amoxicillin challenge of Marine recruits with suspected penicillin allergy revealed that only 1.5% of those challenged acutely reacted and should be considered allergic to penicillin.16 Historically, in order to refute the diagnosis of penicillin allergy, an allergist would order penicillin skin prick testing. If the test was negative, an allergist would proceed to intradermal testing and if negative again (NPV of 97.9%), proceed to a graded oral challenge.6 However, this process is not fully reproducible in most clinics because the minor determinants mixture used in skin testing is not commercially available.17 Additionally, the full skin testing procedure requires specialized training, is more time-consuming, causes more discomfort, lacks US Food and Drug Administration approval for children, and has a higher cost ($220 per test for each patient as of 2016).18 As such, the movement toward direct oral challenges is progressing. Nonetheless, the best method for primary care or emergency department clinicians to determine who the appropriate patients are for this procedure has not been fully established. Risk tools have been created in the past to help delineate low-risk patients who would be appropriate for direct oral amoxicillin challenges, but these were not widely replicated or validated.19 The PEN-FAST standardized risk score was first published in 2020 and has since been validated in different groups with additional safety data. This scoring system ranges from 0 to 5 points, assigning 2 points for a penicillin reaction within the past five (F) years, 2 points for angioedema/anaphylaxis (A) or a severe (S) cutaneous reaction, and 1 point if treatment (T) was required for the reaction. A score < 3 is considered low-risk and safe for direct oral challenge, although most of the safety data are in patients with a score of 0 or 1.20 The PEN-FAST guided direct oral challenge with an NPV of 96.3% has now been prospectively shown to be noninferior to standard skin prick test/intradermal test/graded challenge for low-risk patients with a PEN-FAST score < 3.21 The PEN-FAST validating study was conducted predominantly with an Australian population of adult White women, but now it also has been validated in children aged > 12 years, as well as in European and North American cohorts.22-24

Air Force Delabeling Program

This article describes a method for proactively, safely, and efficiently delabeling penicillin allergic patients at an Air Force clinic. This quality improvement (QI) report provides a successful model for penicillin allergy delabeling, illustrates lessons learned, and suggests next steps toward improving patient options for an invaluable antibiotic class.

The first step was to proactively delabel penicillin allergy from a population of active duty service members and their dependents. Electronic health record (EHR) allergy search functions are a helpful tool in finding patients with allergy labels. The Kadena Medical Clinic, in Okinawa, Japan, uses the Military Health System GENESIS EHR, which includes a discern reporting portal with a patient allergy search that creates a patient-specific medication allergy report. To compile the most complete database of patients with a penicillin allergy, all 15 potential allergy search options for “penicillin” were selected, as were 4 relevant options for amoxicillin (including options with clavulanate). Including so many options for specific penicillin medication allergies helps add specificity to the diagnosis in the EHR but can make aggregation of data more difficult. The report allowed all these specific medications to be selected at once for a particular clinic. However, the report did not populate patients with the allergy listed in other fields or free text.  

The complete compiled list was manually reviewed for high-risk patients with severe cutaneous adverse reactions (SCARs) of any age. Patients with pregnancy, unsuitable medical histories (ie, severe asthma), or taking β-blockers were excluded. Patients remaining on the list were contacted by telephone and offered appointments during a single week that was dedicated to penicillin allergy delabeling. Allergists in the Air Force are assigned to a region where they offer allergy services at clinics without a regular allergist. The allergist for the region traveled to the QI site for a 1-week campaign at an estimated cost of $4600. When the patients were contacted, they were briefly informed of the goal of the penicillin delabeling campaign, and if interested, they were scheduled for 1 of 50 available appointments that week. Patients were contacted with enough lead time to stop oral antihistamines (OAH) for ≥ 7 days before the appointment.  

Patients were given an intake questionnaire and interviewed about their penicillin allergy history. This questionnaire inquired about the nature of the allergy, mental and physical health impacts of the allergy label, PEN-FAST scoring questions, and posttest attitude toward delabeling, if applicable. Patients with a PEN-FAST score < 3 were offered direct, graded oral challenge or the standard skin prick, followed by intradermal, followed by graded oral challenge protocol. Patients with PEN-FAST scores of ≥ 3 were offered skin testing prior to oral challenge protocol. Patients could decline further testing. If patients wished to proceed, they were asked to complete a written informed consent document.  

Oral challenges followed a 10%/90% protocol, beginning with 50 mg of liquid amoxicillin followed by 450 mg after 15 minutes, as long as the patient remained asymptomatic. Challenge forms are available in the eAppendix . After receiving the 450-mg amoxicillin dose, the patient remained in the clinic for 60 minutes before a final clinical evaluation. If the patient remained asymptomatic after this period, the penicillin or amoxicillin allergy was marked as resolved in the EHR. The patients were given contact information for the clinic for follow-up if a delayed reaction was noted and they wished the medication allergy to be re-entered. An EHR encounter note was created for each patient detailing the allergy testing and delabeling.  

FDP04208308_eA

This campaign was conducted at a basic life support-only facility by a single clinician without medical technician support. An allergic reaction medication kit was available and contained OAHs, intramuscular antihistamines, intramuscular epinephrine, intramuscular corticosteroids, and short-acting β-agonists for nebulization. The facility also had an urgent care room (staffed by primary care practitioners [PCPs]) that could help establish intravenous access and administer fluids if necessary and had previously established plans for emergency patient transport to a higher level of care, if necessary.

Program Outcomes

A list of 65 patients that included both active-duty service members and dependents with penicillin or amoxicillin allergy was created. This list was reviewed by an allergist to identify high-risk individuals, which required about 90 minutes. Two patients (3%) were excluded; 1 had a history of SCAR to penicillin and 1 had a complex medical history requiring continued OAH use. Sixty-three patients were contacted via telephone, and 29 patients (46%) scheduled an appointment. One patient (2%) was identified as penicillin-tolerant during the booking process, and the penicillin allergy was removed without testing (Figure 1).

FDP04208308_F1

Of the 29 scheduled patients, 5 patients (17%) failed to present for care. Of the potential appointments set aside for the program, only 42% were used. One patient (4%) who was seen in clinic was delabeled based on history alone as they had previously successfully tolerated a course of amoxicillin. Four patients (17%) declined further testing with a PEN-FAST score > 2 due to a clear history of acute immunoglobulin (Ig) E-mediated reaction to a penicillin product within the past year. One patient (4%) was unable to be tested due to ongoing OAH use and 1 patient (4%) declined further penicillin testing after the discussion about risks, benefits, and alternatives to the procedures offered.  

Of the 24 patients who arrived for a clinic appointment, 17 (71%) underwent penicillin allergy delabeling testing: 14 (82%) underwent direct challenge, and 3 (18%) underwent the skin testing before oral amoxicillin challenge procedure. Of the 17 who were tested, 16 (94%) tolerated a total dose of 500 mg of oral amoxicillin within the 1-hour observation period. One tested patient (6%) in the direct oral challenge group experienced an adverse reaction that was described as dull headache and hand tremor after the 50-mg dose; although it self-resolved within 15 minutes, this prompted the patient to discontinue the challenge. This adverse reaction was determined to be very unlikely IgE-mediated. None of the 3 patients who underwent the skin testing before oral challenge protocol experienced an adverse drug reaction (ADR). None of the 17 patients who received any oral amoxicillin required follow-up or reported a delayed cutaneous ADR to the challenge. No OAHs or epinephrine were used for any of the challenges. 

Data collected from patient questionnaires displayed perceived health impacts of a penicillin allergy on the patient population. Patients reported a variety of ADRs to previous administration of penicillin products: 17 (71%) reported urticaria, 2 (8%) reported anaphylaxis, and 3 (13%) were unable to recall the reaction (Figure 2). Nine patients (38%) felt their initial reaction was distressing. Fifteen patients (88%) felt relief following negative testing (Table).

FDP04208308_F2FDP04208308_T

Discussion

To our knowledge, this was the first documented proactive penicillin delabeling QI project in a military clinic treating both active-duty service members and their dependents, modeled on the 2022 drug allergy guidelines.14 Several interesting lessons were learned that may improve future similar QI projects. Only 46% of patients identified as having penicillin allergy presented for evaluation, leaving 42% of available appointments unused. Without prior data on anticipated participation rates, these data provide a crude benchmark for utilization rates, which can inform future resource planning. While attempts were made to contact each patient, additional efforts to publicize the penicillin allergy delabeling campaign would have been useful to improve efficiency.

In addition, when patients with a PEN-FAST score of < 3 were educated about the risks and benefits of each procedure and offered the direct oral graded challenge and skin testing prior to oral challenge, 82% preferred the direct challenge. None of the patients who experienced a penicillin ADR in the past year wished to undergo skin testing or oral challenge, though each was educated on penicillin allergy and the possibility of testing in the future, making each encounter beneficial. Of the 17 patients tested, 16 (94%) tolerated oral amoxicillin and 1 (6%) experienced a mild, self-resolving ADR that was very unlikely of an IgE-mediated origin. Additionally, while plans and preparations for ADRs to the challenges were available, none were required. Patient questionnaires demonstrated the heterogeneity of previous ADRs and their attitude toward their allergy diagnosis. The positive impact of delabeling on patient well-being noted by 88% of patients reinforced the benefit of the effort.  

This project was limited by a relatively small sample size, which may not have been large enough to detect ADRs, especially IgE-mediated allergic reactions. Herein lies the importance of having clinicians equipped to treat allergic ADRs to conduct penicillin challenges in the primary care setting. It is prudent to ensure not only proper training of physicians performing these challenges, but also appropriate equipment, medication, and response personnel. Medications that are useful include epinephrine, OAHs, albuterol, steroids, and intravenous fluids.  

Having a response area and plan are essential to ensure appropriate care in the rare instance of allergic ADRs progressing to anaphylaxis. In rare cases, emergency medical services may be required and having a plan with appropriate response and transport time is essential to patient safety. This may not be practical in more rural or smaller practices. In those scenarios, it may be helpful to partner with a larger practice to send patients for delabeling or to use clinical space in closer proximity to emergency services. Perhaps an ideal setting might be urgent or emergent care centers due to high acuity resources and frequent prescription of amoxicillin antibiotics; however, this may be complicated by concurrent infections raising the incidence of delayed benign eruptions with amoxicillin ingestion and complicating the patient’s allergy records. Further training of urgent and emergent care practitioners would be helpful for proper patient education regarding antibiotic-associated reactions.  

Full testing integration into other primary care clinics may be limited due to the specialized training required for complete skin testing. Nevertheless, as shown in this project, most patients may be delabeled based on a PEN-FAST evaluation followed by oral challenge alone. Incorporation in other QI projects could involve continuing medical education to train staff physicians on PEN-FAST, teaching primary care residents during training, and site visits by allergists to train local physicians on testing. This project involved training 2 PCPs to conduct skin and oral challenge testing using PEN-FAST to guide clinical decision-making with an allergist available for consultation if needed. Future projects might model a similar approach or perhaps focus on training more physicians on oral challenges alone to reach a high percentage of the target population.

Conclusions

This project demonstrates a safe, efficient, and cost-effective model for penicillin allergy delabeling in clinics without regular access to allergy services. The use of PEN-FAST allows a quick and simple method to screen patients with penicillin allergy to meet the goals of the 2022 CBSs, but data are still accumulating to validate this method of screening across populations. This project demonstrates additional support for the use of PEN-FAST, while illustrating appropriate education regarding oral testing technique and its limitations.

Using an EHR report limited the patients in the testing pool and subsequent sample size. This suggests that a primary care identification-driven enrollment in testing may offer even more benefit both in allergy detection and education of testing benefits. Oral challenges are more cost effective, shorter in duration, and have fewer training requirements when compared with antecedent skin testing, making them an ideal option for PCPs in a clinic setting. Trained PCPs may opt to offer periodic appointments for delabeling, or offer days dedicated to delabeling as many patients as possible. Penicillin delabeling is an urgent and expansive charge; this study offers a replicable model for executing this important task.

References
  1. Macy E, Poon KYT. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009;122(8):778.e1-778.e7787. doi:10.1016/j.amjmed.2009.01.034
  2. Zhou L, Dhopeshwarkar N, Blumenthal KG, et al. Drug allergies documented in electronic health records of a large healthcare system. Allergy. 2016;71(9):1305-1313. doi:10.1111/all.12881
  3. Sullivan TJ, Wedner HJ, Shatz GS, Yecies LD, Parker CW. Skin testing to detect penicillin allergy. J Allergy Clin Immunol. 1981;68(3):171-180. doi:10.1016/0091-6749(81)90180-9
  4. Macy E, Schatz M, Lin C, Poon KY. The falling rate of positive penicillin skin tests from 1995 to 2007. Perm J. 2009;13(2):12-18. doi:10.7812/TPP/08-073
  5. Fox SJ, Park MA. Penicillin skin testing is a safe and effective tool for evaluating penicillin allergy in the pediatric population. J Allergy Clin Immunol Pract. 2014;2(4):439-444. doi:10.1016/j.jaip.2014.04.013
  6. Solensky R, Jacobs J, Lester M, et al. Penicillin Allergy Evaluation: A Prospective, Multicenter, Open-Label Evaluation of a Comprehensive Penicillin Skin Test Kit. J Allergy Clin Immunol Pract. 2019;7(6):1876-1885.e3. doi:10.1016/j.jaip.2019.02.040 7. 
  7. Gonzalez-Estrada A, Park MA, Accarino JJO, et al. Predicting penicillin allergy: A United States multicenter retrospective study. J Allergy Clin Immunol Pract. 2024;12(5):1181-1191.e10. doi:10.1016/j.jaip.2024.01.010
  8. Stüwe HT, Geissler W, Paap A, Cromwell O. The presence of latex can induce false-positive skin tests in subjects tested with penicillin determinants. Allergy. 1997;52(12):1243. doi:10.1111/j.1398-9995.1997.tb00975.x
  9. Charneski L, Deshpande G, Smith SW. Impact of an antimicrobial allergy label in the medical record on clinical outcomes in hospitalized patients. Pharmacotherapy. 2011;31(8):742-747. doi:10.1592/phco.31.8.742
  10. Blumenthal KG, Lu N, Zhang Y, Walensky RP, Choi HK. Recorded penicillin allergy and risk of mortality: a population-based matched cohort study. J Gen Intern Med. 2019;34(9):1685-1687. doi:10.1007/s11606-019-04991-y
  11. Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin “allergy” in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014;133(3):790-796. doi:10.1016/j.jaci.2013.09.021
  12. Mattingly TJ II, Fulton A, Lumish RA, et al. The cost of self-reported penicillin allergy: a systematic review. J Allergy Clin Immunol Pract. 2018;6(5):1649-1654.e4. doi:10.1016/j.jaip.2017.12.033
  13. Diplomate Statistics. American Board of Allergy and Immunology website. Published February, 18 2021. Accessed July 28, 2025. https://www.abai.org/statistics_diplomates.asp
  14. Khan DA, Banerji A, Blumenthal KG, et al. Drug allergy: a 2022 practice parameter update. J Allergy Clin Immunol. 2022;150(6):1333-1393. doi:10.1016/j.jaci.2022.08.028 
  15. Mill C, Primeau MN, Medoff E, et al. Assessing the diagnostic properties of a graded oral provocation challenge for the diagnosis of immediate and nonimmediate reactions to amoxicillin in children. JAMA Pediatr. 2016;170:e160033. doi:10.1001/jamapediatrics.2016.0033
  16. Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017;5(3):813-815. doi:10.1016/j.jaip.2017.01.023
  17. Shenoy ES, Macy E, Rowe T, Blumenthal KG. Evaluation and management of penicillin allergy: a review. JAMA. 2019;321(2):188–99. doi:10.1001/jama.2018.19283
  18. Blumenthal KG, Li Y, Banerji A, et al. The cost of penicillin allergy evaluation. J Allergy Clin Immunol Pract. 2018;6(3):1019-1027.e2. doi:10.1016/j.jaip.2017.08.006
  19. Banks TA, Tucker M, Macy E. Evaluating penicillin allergies without skin testing. Curr Allergy Asthma Rep. 2019;19(5):27. doi:10.1007/s11882-019-0854-6
  20. Trubiano JA, Vogrin S, Chua KYL, et al. Development and validation of a penicillin allergy clinical decision rule. JAMA Intern Med. 2020;180(5):745-752. doi:10.1001/jamainternmed.2020.0403
  21. Copaescu AM, Vogrin S, James F, et al. Efficacy of a clinical decision rule to enable direct oral challenge in patients with low-risk penicillin allergy: the PALACE randomized clinical trial. JAMA Intern Med. 2023;183(9):944-952. doi:10.1001/jamainternmed.2023.2986
  22. Copaescu AM, Vogrin S, Shand G, et al. Validation of the PEN-FAST score in a pediatric population. JAMA Netw Open. 2022;5(9):e2233703. doi:10.1001/jamanetworkopen.2022.33703
  23. Piotin A, Godet J, Trubiano JA, et al. Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. Ann Allergy Asthma Immunol. 2022;128(1):27-32. doi:10.1016/j.anai.2021.07.005
  24. Su C, Belmont A, Liao J, et al. Evaluating the PEN-FAST clinical decision-making tool to enhance penicillin allergy delabeling. JAMA Intern Med. 2023;183(8):883-885. doi:10.1001/jamainternmed.2023.1572
References
  1. Macy E, Poon KYT. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009;122(8):778.e1-778.e7787. doi:10.1016/j.amjmed.2009.01.034
  2. Zhou L, Dhopeshwarkar N, Blumenthal KG, et al. Drug allergies documented in electronic health records of a large healthcare system. Allergy. 2016;71(9):1305-1313. doi:10.1111/all.12881
  3. Sullivan TJ, Wedner HJ, Shatz GS, Yecies LD, Parker CW. Skin testing to detect penicillin allergy. J Allergy Clin Immunol. 1981;68(3):171-180. doi:10.1016/0091-6749(81)90180-9
  4. Macy E, Schatz M, Lin C, Poon KY. The falling rate of positive penicillin skin tests from 1995 to 2007. Perm J. 2009;13(2):12-18. doi:10.7812/TPP/08-073
  5. Fox SJ, Park MA. Penicillin skin testing is a safe and effective tool for evaluating penicillin allergy in the pediatric population. J Allergy Clin Immunol Pract. 2014;2(4):439-444. doi:10.1016/j.jaip.2014.04.013
  6. Solensky R, Jacobs J, Lester M, et al. Penicillin Allergy Evaluation: A Prospective, Multicenter, Open-Label Evaluation of a Comprehensive Penicillin Skin Test Kit. J Allergy Clin Immunol Pract. 2019;7(6):1876-1885.e3. doi:10.1016/j.jaip.2019.02.040 7. 
  7. Gonzalez-Estrada A, Park MA, Accarino JJO, et al. Predicting penicillin allergy: A United States multicenter retrospective study. J Allergy Clin Immunol Pract. 2024;12(5):1181-1191.e10. doi:10.1016/j.jaip.2024.01.010
  8. Stüwe HT, Geissler W, Paap A, Cromwell O. The presence of latex can induce false-positive skin tests in subjects tested with penicillin determinants. Allergy. 1997;52(12):1243. doi:10.1111/j.1398-9995.1997.tb00975.x
  9. Charneski L, Deshpande G, Smith SW. Impact of an antimicrobial allergy label in the medical record on clinical outcomes in hospitalized patients. Pharmacotherapy. 2011;31(8):742-747. doi:10.1592/phco.31.8.742
  10. Blumenthal KG, Lu N, Zhang Y, Walensky RP, Choi HK. Recorded penicillin allergy and risk of mortality: a population-based matched cohort study. J Gen Intern Med. 2019;34(9):1685-1687. doi:10.1007/s11606-019-04991-y
  11. Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin “allergy” in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014;133(3):790-796. doi:10.1016/j.jaci.2013.09.021
  12. Mattingly TJ II, Fulton A, Lumish RA, et al. The cost of self-reported penicillin allergy: a systematic review. J Allergy Clin Immunol Pract. 2018;6(5):1649-1654.e4. doi:10.1016/j.jaip.2017.12.033
  13. Diplomate Statistics. American Board of Allergy and Immunology website. Published February, 18 2021. Accessed July 28, 2025. https://www.abai.org/statistics_diplomates.asp
  14. Khan DA, Banerji A, Blumenthal KG, et al. Drug allergy: a 2022 practice parameter update. J Allergy Clin Immunol. 2022;150(6):1333-1393. doi:10.1016/j.jaci.2022.08.028 
  15. Mill C, Primeau MN, Medoff E, et al. Assessing the diagnostic properties of a graded oral provocation challenge for the diagnosis of immediate and nonimmediate reactions to amoxicillin in children. JAMA Pediatr. 2016;170:e160033. doi:10.1001/jamapediatrics.2016.0033
  16. Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017;5(3):813-815. doi:10.1016/j.jaip.2017.01.023
  17. Shenoy ES, Macy E, Rowe T, Blumenthal KG. Evaluation and management of penicillin allergy: a review. JAMA. 2019;321(2):188–99. doi:10.1001/jama.2018.19283
  18. Blumenthal KG, Li Y, Banerji A, et al. The cost of penicillin allergy evaluation. J Allergy Clin Immunol Pract. 2018;6(3):1019-1027.e2. doi:10.1016/j.jaip.2017.08.006
  19. Banks TA, Tucker M, Macy E. Evaluating penicillin allergies without skin testing. Curr Allergy Asthma Rep. 2019;19(5):27. doi:10.1007/s11882-019-0854-6
  20. Trubiano JA, Vogrin S, Chua KYL, et al. Development and validation of a penicillin allergy clinical decision rule. JAMA Intern Med. 2020;180(5):745-752. doi:10.1001/jamainternmed.2020.0403
  21. Copaescu AM, Vogrin S, James F, et al. Efficacy of a clinical decision rule to enable direct oral challenge in patients with low-risk penicillin allergy: the PALACE randomized clinical trial. JAMA Intern Med. 2023;183(9):944-952. doi:10.1001/jamainternmed.2023.2986
  22. Copaescu AM, Vogrin S, Shand G, et al. Validation of the PEN-FAST score in a pediatric population. JAMA Netw Open. 2022;5(9):e2233703. doi:10.1001/jamanetworkopen.2022.33703
  23. Piotin A, Godet J, Trubiano JA, et al. Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. Ann Allergy Asthma Immunol. 2022;128(1):27-32. doi:10.1016/j.anai.2021.07.005
  24. Su C, Belmont A, Liao J, et al. Evaluating the PEN-FAST clinical decision-making tool to enhance penicillin allergy delabeling. JAMA Intern Med. 2023;183(8):883-885. doi:10.1001/jamainternmed.2023.1572
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Profound Hypoxemia in a Patient With Hypertriglyceridemia-Induced Pancreatitis

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Profound Hypoxemia in a Patient With Hypertriglyceridemia-Induced Pancreatitis

Acute pancreatitis can be associated with multiorgan system failure, including respiratory failure, which has a high mortality rate. Acute respiratory distress syndrome (ARDS) is a known complication of severe, acute pancreatitis, and is fatal in up to 40% of cases. Mortality rates exceed 80% in patients with PaO2/FiO2 < 100 mm Hg.2 Although ARDS is typically associated with bilateral pulmonary infiltrates, severe hypoxemia in pancreatitis may not be visible in radiography in up to 50% of cases.1

Hypertriglyceridemia is the third-most common cause of acute pancreatitis, with an incidence of 2% to 10% among patients diagnosed with acute pancreatitis.3.4 Elevated serum triglycerides have been proposed to trigger acute pancreatitis by increasing plasma viscosity, which leads to ischemia and inflammation of the pancreas.4 In severe cases of hypertriglyceridemia-induced acute pancreatitis, plasmapheresis is used to rapidly reduce serum chylomicron and triglyceride levels.3    

This case report discusses a patient with acute pancreatitis whose hypoxemia coincided with the severity of hypertriglyceridemia, but without radiographic evidence of pulmonary infiltrates or other known pulmonary causes.

Case Presentation

A 60-year-old male presented to the emergency department with several hours of diffuse abdominal pain, nausea, and vomiting. The patient reported that his symptoms began after eating fried chicken. He reported no dyspnea, fever, chills, or other symptoms. His medical history included type 2 diabetes (hemoglobin A1c, 11.1%), Hashimoto hypothyroidism, severe obstructive sleep apnea not on continuous positive airway pressure (apnea-hypoxia index, 59/h), and obesity (body mass index, 52). Initial vital signs were afebrile, heart rate of 90 beats/min, and oxygen saturation (SpO2) of 85% on 6L oxygen via nasal cannula. He was admitted to the intensive care unit and quickly maximized on high flow nasal cannula, ultimately requiring endotracheal intubation and mechanical ventilation.

Initial laboratory studies were remarkable for serum sodium of 120 mmol/L (reference range, 136-146 mmol/L), creatinine of 1.65 mg/dL (reference range, 0.52-1.28 mg/dL), anion gap of 18 mEq/L (reference range, 3-11 mEq/L), lipase level of 1115 U/L (reference range, 11-82 U/L), glucose level of 334 mg/dL (reference range, 70-110 mg/dL), white blood count of 13.1 K/uL (reference range, 4.5-11.0 K/uL), lactate level of 3.8 mmol/L (reference range, 0.5-2.2 mmol/L), triglyceride level of 1605 mg/dL (reference range, 40-160 mg/dL), cholesterol level of 565 mg/dL (reference range, < 200 mg/dL), aminotransferase of 21 U/L (reference range, 13-36 U/L), alanine aminotransferase of < 3 U/L (reference range, 7-45 U/L), and total bilirubin level of 1.6 mg/dL (reference range, 0.2-1 mg/dL).     

The patient had an initial arterial blood gas pH of 7.26, partial pressure of CO2 and O2 of 64.1 mm Hg and 74.1 mm Hg, respectively, on volume control with a tidal volume of 500 mL, positive end-expiratory pressure of 10 cm H2O, respiratory rate of 26 breaths/min, and FiO2 was 100%, which yielded a PaO2/FiO2 of 74 mm Hg. The patient was maintained in steep reverse-Trendelenburg position with moderate improvement in his SpO2.    

Chest X-ray and computed tomography angiogram did not reveal pleural effusions, pulmonary infiltrates, or pulmonary embolism (Figure 1). Computed tomography of the abdomen and pelvis demonstrated severe acute interstitial edematous pancreatitis with no evidence of pancreatic necrosis or evidence of gallstones (Figure 2). A transthoracic echocardiogram with bubble was negative for intracardiac right to left shunting.    

FDP04208304_F1
FDP04208304_F2
The leading diagnosis was ARDS secondary to acute pancreatitis with hypoxemia exacerbated by morbid obesity and untreated obstructive sleep apnea leading to hypoventilation.

Treatment

The patient was intubated and restricted to nothing by mouth and provided fluid resuscitation with crystalloids. On hospital day 1, he remained intubated and on mechanical ventilation, started on plasmapheresis and continued insulin infusion for severe hypertriglyceridemia. The patient’s PaO2/FiO2 ratio remained persistently < 100 mm Hg despite maximal ventilatory support. After 3 sessions of plasmapheresis, the serum triglyceride levels and oxygen requirements improved (Figure 3).

FDP04208304_F3

Due to prolonged intubation, the patient ultimately required a tracheostomy. By hospital day 48, the patient was successfully weaned off mechanical ventilation. His tracheostomy was decannulated uneventfully on hospital day 55 and the stoma was closed. The patient was discharged to a skilled nursing home for rehabilitation and received intensive physical therapy for deconditioning from prolonged hospitalization.

Discussion

Respiratory insufficiency is a common and potentially lethal complication observed in one-third of patients with acute pancreatitis.1 Radiographic evidence of pleural effusions, atelectasis and pulmonary infiltrates are often present. Acute lung injury (ALI) and ARDS are the most severe pulmonary complications of acute pancreatitis.5 It has been proposed that ALI and ARDS are driven by a hyperinflammatory state, which has multiple downstream effects. Pulmonary parenchymal and vascular damage has been associated with activated proinflammatory cytokines, trypsin, phospholipase A, and free fatty acids (Figure 4).1

FDP04208304_F4

Hypoxemia secondary to acute pancreatitis may occur without initial radiographic findings and has been observed in up to half of patients.1 Hypoxemia in ARDS occurs due to ventilation-perfusion defects causing gas exchange impairments which may be worsened further by high distending volumes and pressures on mechanical ventilation, dyssynchronous breathing, and/or lung derecruitment.6 Patients who require intubation for pancreatitis-associated ALI or ARDS eventually exhibit imaging findings consistent with their disease.1 The patient in this case exhibited severe hypoxemia for several days despite persistently negative radiographic studies. His history of obstructive sleep apnea and a body mass index of 52 may have contributed to respiratory failure; however, assessment of other contributors to the acute and profound hypoxemia yielded largely unremarkable results. The patient did not have a history or evidence of heart failure and his hypoxemia did not improve with diuresis. He tested positive for COVID-19 on admission and was briefly treated with remdesivir and dexamethasone, but it was determined that the test was likely a false positive due to negative subsequent tests and elevated cycle thresholds (> 40). A concomitant COVID-19 infection likely did not contribute to his symptoms.    

Ventilation-perfusion mismatch is a well-recognized complication of pancreatitis, which results in right-to-left shunting.5 While we considered whether an intracardiac shunt may have contributed to the patient’s hypoxemia, a transthoracic echocardiogram with bubble contrast was negative.    

The patient had a peak serum triglyceride of > 6000 mg/dl, which meets the criteria for very severe hypertriglyceridemia.7 As observed in prior reports, the extent of the hypertriglyceridemia in this patient resulted in pronounced lipemic blood, which was appreciable by the eye and necessitated several rounds of centrifugation to analyze the laboratory studies.8 In this case, plasmapheresis was used to rapidly treat the hypertriglyceridemia, thereby reducing inflammation and further damage to the pancreas.9    

It is possible the patient’s hypertriglyceridemia may have been associated with his hypoxemia. His hypoxemia was most pronounced approximately 24 hours postadmission, which coincided with the peak of the hypertriglyceridemia. It remains unclear whether the severity of triglyceride elevation could accurately predict the severity of respiratory insufficiency. Hypoxemia is thought to modulate triglyceride metabolism through stimulation of intracellular lipolysis, upregulation of very low-density lipoproteins production in the liver, and inhibition of triglyceride-rich lipoprotein metabolism.10 Evidence from rodent studies supports the idea that acute hypoxemia increases triglycerides, and the degree of hypoxemia correlates with the elevated triglyceride levels.11 However, this has not been consistently observed in humans and may vary by prandial state.12,13 Thus, dysfunction of lipid metabolism may be a relevant clinical indicator of hypoxemia; further work is needed to elucidate this association.

Patient Perspective

The patient continues to undergo extensive rehabilitation following his prolonged illness and hospitalization. He expressed gratitude for the care received. However, he has limited and distorted recollection of the events during his hospitalization and stated that it felt “like an extraterrestrial state.”

Conclusions

This report describes a case of marked hypoxemia in the setting of acute pancreatitis. Pulmonary insufficiency in acute pancreatitis is commonly associated with imaging findings such as atelectasis, pleural effusions, and pulmonary infiltrates; however, up to half of cases initially lack any radiographic findings. Plasmapheresis is an effective treatment for hypertriglyceridemia-induced pancreatitis to both directly reduce circulating triglycerides and inflammation. Plasmapheresis also represents a promising therapy for the prevention of further episodes of pancreatitis in patients with recurrent pancreatitis. We propose a feedback mechanism through which pancreatitis induces severe hypoxemia, which may modulate lipid metabolism and severe hypertriglyceridemia correlates with respiratory failure.

References
  1. Zhou M-T, Chen C-S, Chen B-C, Zhang Q-Y, Andersson R. Acute lung injury and ARDS in acute pancreatitis: mechanisms and potential intervention. World J Gastroenterol. 2010;16(17):2094-2099. doi:10.3748/wjg.v16.i17.2094
  2. Peek GJ, White S, Scott AD, et al. Severe acute respiratory distress syndrome secondary to acute pancreatitis successfully treated with extracorporeal membrane oxygenation in three patients. Ann Surg. 1998;227(4):572-574. doi:10.1097/00000658-199804000-00020
  3. Searles GE, Ooi TC. Underrecognition of chylomicronemia as a cause of acute pancreatitis. Can Med Assoc J. 1992;147(12):1806-1808.
  4. de Pretis N, Amodio A, Frulloni L. Hypertriglyceridemic pancreatitis: Epidemiology, pathophysiology and clinical management. United European Gastroenterol J. 2018;6(5):649-655. doi:10.1177/2050640618755002
  5. Ranson JH, Turner JW, Roses DF, et al. Respiratory compli cations in acute pancreatitis. Ann Surg. 1974;179(5):557-566. doi:10.1097/00000658-197405000-00006 6. Swenson KE, Swenson ER. Pathophysiology of acute respiratory distress syndrome and COVID-19 lung injury. Crit Care Clin. 2021;37(4):749-776. doi:10.1016/j.ccc.2021.05.003
  6. Swenson KE, Swenson ER. Pathophysiology of acute respiratory distress syndrome and COVID- 19 lung injury. Crit Care Clin. 2021;37(4):749-776. doi:10.1016/j.ccc.2021.05.003
  7. Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(9):2969-2989. doi:10.1210/jc.2011-3213
  8. Ahern BJ, Yi HJ, Somma CL. Hypertriglyceridemia-induced pancreatitis and a lipemic blood sample: a case report and brief clinical review. J Emerg Nurs. 2022;48(4):455-459. doi:10.1016/j.jen.2022.02.001
  9. Garg R, Rustagi T. Management of hypertriglyceridemia induced acute pancreatitis. Biomed Res Int. 2018;2018:4721357. doi:10.1155/2018/4721357
  10. Morin R, Goulet N, Mauger J-F, Imbeault P. Physiological responses to hypoxia on triglyceride levels. Front Physiol. 2021;12:730935. doi:10.3389/fphys.2021.730935
  11. Jun JC, Shin M-K, Yao Q, et al. Acute hypoxia induces hypertriglyceridemia by decreasing plasma triglyceride clearance in mice. Am J Physiol Endocrinol Metab. 2012;303(3):E377-88. doi:10.1152/ajpendo.00641.2011
  12. Mahat B, Chassé É, Lindon C, Mauger J-F, Imbeault P. No effect of acute normobaric hypoxia on plasma triglyceride levels in fasting healthy men. Appl Physiol Nutr Metab. 2018;43(7):727-732. doi:10.1139/apnm-2017-0505
  13. Mauger J-F, Chassé É, Mahat B, Lindon C, Bordenave N, Imbeault P. The effect of acute continuous hypoxia on triglyceride levels in constantly fed healthy men. Front Physiol. 2019;10:752. doi:10.3389/fphys.2019.00752
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Eileen Nguyen, MD, PhDa; Jeffrey Xia, MDb; Jennifer S. Kim, MDa; Melisa R. Chang, MDb,c; Jaime Betancourt, MDb,c; Dale Jun, MDb,c

Author affiliations 
aUCLA, Los Angeles, California 
bDavid Geffen School of Medicine at UCLA, Los Angeles, California 
cGreater Los Angeles Veterans Affairs Healthcare System, California

Author disclosures 
Authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Dale Jun ([email protected])

Fed Pract. 2025;42(8). Published online August 16. doi:10.12788/fp.0610

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Eileen Nguyen, MD, PhDa; Jeffrey Xia, MDb; Jennifer S. Kim, MDa; Melisa R. Chang, MDb,c; Jaime Betancourt, MDb,c; Dale Jun, MDb,c

Author affiliations 
aUCLA, Los Angeles, California 
bDavid Geffen School of Medicine at UCLA, Los Angeles, California 
cGreater Los Angeles Veterans Affairs Healthcare System, California

Author disclosures 
Authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Dale Jun ([email protected])

Fed Pract. 2025;42(8). Published online August 16. doi:10.12788/fp.0610

Author and Disclosure Information

Eileen Nguyen, MD, PhDa; Jeffrey Xia, MDb; Jennifer S. Kim, MDa; Melisa R. Chang, MDb,c; Jaime Betancourt, MDb,c; Dale Jun, MDb,c

Author affiliations 
aUCLA, Los Angeles, California 
bDavid Geffen School of Medicine at UCLA, Los Angeles, California 
cGreater Los Angeles Veterans Affairs Healthcare System, California

Author disclosures 
Authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Dale Jun ([email protected])

Fed Pract. 2025;42(8). Published online August 16. doi:10.12788/fp.0610

Article PDF
Article PDF

Acute pancreatitis can be associated with multiorgan system failure, including respiratory failure, which has a high mortality rate. Acute respiratory distress syndrome (ARDS) is a known complication of severe, acute pancreatitis, and is fatal in up to 40% of cases. Mortality rates exceed 80% in patients with PaO2/FiO2 < 100 mm Hg.2 Although ARDS is typically associated with bilateral pulmonary infiltrates, severe hypoxemia in pancreatitis may not be visible in radiography in up to 50% of cases.1

Hypertriglyceridemia is the third-most common cause of acute pancreatitis, with an incidence of 2% to 10% among patients diagnosed with acute pancreatitis.3.4 Elevated serum triglycerides have been proposed to trigger acute pancreatitis by increasing plasma viscosity, which leads to ischemia and inflammation of the pancreas.4 In severe cases of hypertriglyceridemia-induced acute pancreatitis, plasmapheresis is used to rapidly reduce serum chylomicron and triglyceride levels.3    

This case report discusses a patient with acute pancreatitis whose hypoxemia coincided with the severity of hypertriglyceridemia, but without radiographic evidence of pulmonary infiltrates or other known pulmonary causes.

Case Presentation

A 60-year-old male presented to the emergency department with several hours of diffuse abdominal pain, nausea, and vomiting. The patient reported that his symptoms began after eating fried chicken. He reported no dyspnea, fever, chills, or other symptoms. His medical history included type 2 diabetes (hemoglobin A1c, 11.1%), Hashimoto hypothyroidism, severe obstructive sleep apnea not on continuous positive airway pressure (apnea-hypoxia index, 59/h), and obesity (body mass index, 52). Initial vital signs were afebrile, heart rate of 90 beats/min, and oxygen saturation (SpO2) of 85% on 6L oxygen via nasal cannula. He was admitted to the intensive care unit and quickly maximized on high flow nasal cannula, ultimately requiring endotracheal intubation and mechanical ventilation.

Initial laboratory studies were remarkable for serum sodium of 120 mmol/L (reference range, 136-146 mmol/L), creatinine of 1.65 mg/dL (reference range, 0.52-1.28 mg/dL), anion gap of 18 mEq/L (reference range, 3-11 mEq/L), lipase level of 1115 U/L (reference range, 11-82 U/L), glucose level of 334 mg/dL (reference range, 70-110 mg/dL), white blood count of 13.1 K/uL (reference range, 4.5-11.0 K/uL), lactate level of 3.8 mmol/L (reference range, 0.5-2.2 mmol/L), triglyceride level of 1605 mg/dL (reference range, 40-160 mg/dL), cholesterol level of 565 mg/dL (reference range, < 200 mg/dL), aminotransferase of 21 U/L (reference range, 13-36 U/L), alanine aminotransferase of < 3 U/L (reference range, 7-45 U/L), and total bilirubin level of 1.6 mg/dL (reference range, 0.2-1 mg/dL).     

The patient had an initial arterial blood gas pH of 7.26, partial pressure of CO2 and O2 of 64.1 mm Hg and 74.1 mm Hg, respectively, on volume control with a tidal volume of 500 mL, positive end-expiratory pressure of 10 cm H2O, respiratory rate of 26 breaths/min, and FiO2 was 100%, which yielded a PaO2/FiO2 of 74 mm Hg. The patient was maintained in steep reverse-Trendelenburg position with moderate improvement in his SpO2.    

Chest X-ray and computed tomography angiogram did not reveal pleural effusions, pulmonary infiltrates, or pulmonary embolism (Figure 1). Computed tomography of the abdomen and pelvis demonstrated severe acute interstitial edematous pancreatitis with no evidence of pancreatic necrosis or evidence of gallstones (Figure 2). A transthoracic echocardiogram with bubble was negative for intracardiac right to left shunting.    

FDP04208304_F1
FDP04208304_F2
The leading diagnosis was ARDS secondary to acute pancreatitis with hypoxemia exacerbated by morbid obesity and untreated obstructive sleep apnea leading to hypoventilation.

Treatment

The patient was intubated and restricted to nothing by mouth and provided fluid resuscitation with crystalloids. On hospital day 1, he remained intubated and on mechanical ventilation, started on plasmapheresis and continued insulin infusion for severe hypertriglyceridemia. The patient’s PaO2/FiO2 ratio remained persistently < 100 mm Hg despite maximal ventilatory support. After 3 sessions of plasmapheresis, the serum triglyceride levels and oxygen requirements improved (Figure 3).

FDP04208304_F3

Due to prolonged intubation, the patient ultimately required a tracheostomy. By hospital day 48, the patient was successfully weaned off mechanical ventilation. His tracheostomy was decannulated uneventfully on hospital day 55 and the stoma was closed. The patient was discharged to a skilled nursing home for rehabilitation and received intensive physical therapy for deconditioning from prolonged hospitalization.

Discussion

Respiratory insufficiency is a common and potentially lethal complication observed in one-third of patients with acute pancreatitis.1 Radiographic evidence of pleural effusions, atelectasis and pulmonary infiltrates are often present. Acute lung injury (ALI) and ARDS are the most severe pulmonary complications of acute pancreatitis.5 It has been proposed that ALI and ARDS are driven by a hyperinflammatory state, which has multiple downstream effects. Pulmonary parenchymal and vascular damage has been associated with activated proinflammatory cytokines, trypsin, phospholipase A, and free fatty acids (Figure 4).1

FDP04208304_F4

Hypoxemia secondary to acute pancreatitis may occur without initial radiographic findings and has been observed in up to half of patients.1 Hypoxemia in ARDS occurs due to ventilation-perfusion defects causing gas exchange impairments which may be worsened further by high distending volumes and pressures on mechanical ventilation, dyssynchronous breathing, and/or lung derecruitment.6 Patients who require intubation for pancreatitis-associated ALI or ARDS eventually exhibit imaging findings consistent with their disease.1 The patient in this case exhibited severe hypoxemia for several days despite persistently negative radiographic studies. His history of obstructive sleep apnea and a body mass index of 52 may have contributed to respiratory failure; however, assessment of other contributors to the acute and profound hypoxemia yielded largely unremarkable results. The patient did not have a history or evidence of heart failure and his hypoxemia did not improve with diuresis. He tested positive for COVID-19 on admission and was briefly treated with remdesivir and dexamethasone, but it was determined that the test was likely a false positive due to negative subsequent tests and elevated cycle thresholds (> 40). A concomitant COVID-19 infection likely did not contribute to his symptoms.    

Ventilation-perfusion mismatch is a well-recognized complication of pancreatitis, which results in right-to-left shunting.5 While we considered whether an intracardiac shunt may have contributed to the patient’s hypoxemia, a transthoracic echocardiogram with bubble contrast was negative.    

The patient had a peak serum triglyceride of > 6000 mg/dl, which meets the criteria for very severe hypertriglyceridemia.7 As observed in prior reports, the extent of the hypertriglyceridemia in this patient resulted in pronounced lipemic blood, which was appreciable by the eye and necessitated several rounds of centrifugation to analyze the laboratory studies.8 In this case, plasmapheresis was used to rapidly treat the hypertriglyceridemia, thereby reducing inflammation and further damage to the pancreas.9    

It is possible the patient’s hypertriglyceridemia may have been associated with his hypoxemia. His hypoxemia was most pronounced approximately 24 hours postadmission, which coincided with the peak of the hypertriglyceridemia. It remains unclear whether the severity of triglyceride elevation could accurately predict the severity of respiratory insufficiency. Hypoxemia is thought to modulate triglyceride metabolism through stimulation of intracellular lipolysis, upregulation of very low-density lipoproteins production in the liver, and inhibition of triglyceride-rich lipoprotein metabolism.10 Evidence from rodent studies supports the idea that acute hypoxemia increases triglycerides, and the degree of hypoxemia correlates with the elevated triglyceride levels.11 However, this has not been consistently observed in humans and may vary by prandial state.12,13 Thus, dysfunction of lipid metabolism may be a relevant clinical indicator of hypoxemia; further work is needed to elucidate this association.

Patient Perspective

The patient continues to undergo extensive rehabilitation following his prolonged illness and hospitalization. He expressed gratitude for the care received. However, he has limited and distorted recollection of the events during his hospitalization and stated that it felt “like an extraterrestrial state.”

Conclusions

This report describes a case of marked hypoxemia in the setting of acute pancreatitis. Pulmonary insufficiency in acute pancreatitis is commonly associated with imaging findings such as atelectasis, pleural effusions, and pulmonary infiltrates; however, up to half of cases initially lack any radiographic findings. Plasmapheresis is an effective treatment for hypertriglyceridemia-induced pancreatitis to both directly reduce circulating triglycerides and inflammation. Plasmapheresis also represents a promising therapy for the prevention of further episodes of pancreatitis in patients with recurrent pancreatitis. We propose a feedback mechanism through which pancreatitis induces severe hypoxemia, which may modulate lipid metabolism and severe hypertriglyceridemia correlates with respiratory failure.

Acute pancreatitis can be associated with multiorgan system failure, including respiratory failure, which has a high mortality rate. Acute respiratory distress syndrome (ARDS) is a known complication of severe, acute pancreatitis, and is fatal in up to 40% of cases. Mortality rates exceed 80% in patients with PaO2/FiO2 < 100 mm Hg.2 Although ARDS is typically associated with bilateral pulmonary infiltrates, severe hypoxemia in pancreatitis may not be visible in radiography in up to 50% of cases.1

Hypertriglyceridemia is the third-most common cause of acute pancreatitis, with an incidence of 2% to 10% among patients diagnosed with acute pancreatitis.3.4 Elevated serum triglycerides have been proposed to trigger acute pancreatitis by increasing plasma viscosity, which leads to ischemia and inflammation of the pancreas.4 In severe cases of hypertriglyceridemia-induced acute pancreatitis, plasmapheresis is used to rapidly reduce serum chylomicron and triglyceride levels.3    

This case report discusses a patient with acute pancreatitis whose hypoxemia coincided with the severity of hypertriglyceridemia, but without radiographic evidence of pulmonary infiltrates or other known pulmonary causes.

Case Presentation

A 60-year-old male presented to the emergency department with several hours of diffuse abdominal pain, nausea, and vomiting. The patient reported that his symptoms began after eating fried chicken. He reported no dyspnea, fever, chills, or other symptoms. His medical history included type 2 diabetes (hemoglobin A1c, 11.1%), Hashimoto hypothyroidism, severe obstructive sleep apnea not on continuous positive airway pressure (apnea-hypoxia index, 59/h), and obesity (body mass index, 52). Initial vital signs were afebrile, heart rate of 90 beats/min, and oxygen saturation (SpO2) of 85% on 6L oxygen via nasal cannula. He was admitted to the intensive care unit and quickly maximized on high flow nasal cannula, ultimately requiring endotracheal intubation and mechanical ventilation.

Initial laboratory studies were remarkable for serum sodium of 120 mmol/L (reference range, 136-146 mmol/L), creatinine of 1.65 mg/dL (reference range, 0.52-1.28 mg/dL), anion gap of 18 mEq/L (reference range, 3-11 mEq/L), lipase level of 1115 U/L (reference range, 11-82 U/L), glucose level of 334 mg/dL (reference range, 70-110 mg/dL), white blood count of 13.1 K/uL (reference range, 4.5-11.0 K/uL), lactate level of 3.8 mmol/L (reference range, 0.5-2.2 mmol/L), triglyceride level of 1605 mg/dL (reference range, 40-160 mg/dL), cholesterol level of 565 mg/dL (reference range, < 200 mg/dL), aminotransferase of 21 U/L (reference range, 13-36 U/L), alanine aminotransferase of < 3 U/L (reference range, 7-45 U/L), and total bilirubin level of 1.6 mg/dL (reference range, 0.2-1 mg/dL).     

The patient had an initial arterial blood gas pH of 7.26, partial pressure of CO2 and O2 of 64.1 mm Hg and 74.1 mm Hg, respectively, on volume control with a tidal volume of 500 mL, positive end-expiratory pressure of 10 cm H2O, respiratory rate of 26 breaths/min, and FiO2 was 100%, which yielded a PaO2/FiO2 of 74 mm Hg. The patient was maintained in steep reverse-Trendelenburg position with moderate improvement in his SpO2.    

Chest X-ray and computed tomography angiogram did not reveal pleural effusions, pulmonary infiltrates, or pulmonary embolism (Figure 1). Computed tomography of the abdomen and pelvis demonstrated severe acute interstitial edematous pancreatitis with no evidence of pancreatic necrosis or evidence of gallstones (Figure 2). A transthoracic echocardiogram with bubble was negative for intracardiac right to left shunting.    

FDP04208304_F1
FDP04208304_F2
The leading diagnosis was ARDS secondary to acute pancreatitis with hypoxemia exacerbated by morbid obesity and untreated obstructive sleep apnea leading to hypoventilation.

Treatment

The patient was intubated and restricted to nothing by mouth and provided fluid resuscitation with crystalloids. On hospital day 1, he remained intubated and on mechanical ventilation, started on plasmapheresis and continued insulin infusion for severe hypertriglyceridemia. The patient’s PaO2/FiO2 ratio remained persistently < 100 mm Hg despite maximal ventilatory support. After 3 sessions of plasmapheresis, the serum triglyceride levels and oxygen requirements improved (Figure 3).

FDP04208304_F3

Due to prolonged intubation, the patient ultimately required a tracheostomy. By hospital day 48, the patient was successfully weaned off mechanical ventilation. His tracheostomy was decannulated uneventfully on hospital day 55 and the stoma was closed. The patient was discharged to a skilled nursing home for rehabilitation and received intensive physical therapy for deconditioning from prolonged hospitalization.

Discussion

Respiratory insufficiency is a common and potentially lethal complication observed in one-third of patients with acute pancreatitis.1 Radiographic evidence of pleural effusions, atelectasis and pulmonary infiltrates are often present. Acute lung injury (ALI) and ARDS are the most severe pulmonary complications of acute pancreatitis.5 It has been proposed that ALI and ARDS are driven by a hyperinflammatory state, which has multiple downstream effects. Pulmonary parenchymal and vascular damage has been associated with activated proinflammatory cytokines, trypsin, phospholipase A, and free fatty acids (Figure 4).1

FDP04208304_F4

Hypoxemia secondary to acute pancreatitis may occur without initial radiographic findings and has been observed in up to half of patients.1 Hypoxemia in ARDS occurs due to ventilation-perfusion defects causing gas exchange impairments which may be worsened further by high distending volumes and pressures on mechanical ventilation, dyssynchronous breathing, and/or lung derecruitment.6 Patients who require intubation for pancreatitis-associated ALI or ARDS eventually exhibit imaging findings consistent with their disease.1 The patient in this case exhibited severe hypoxemia for several days despite persistently negative radiographic studies. His history of obstructive sleep apnea and a body mass index of 52 may have contributed to respiratory failure; however, assessment of other contributors to the acute and profound hypoxemia yielded largely unremarkable results. The patient did not have a history or evidence of heart failure and his hypoxemia did not improve with diuresis. He tested positive for COVID-19 on admission and was briefly treated with remdesivir and dexamethasone, but it was determined that the test was likely a false positive due to negative subsequent tests and elevated cycle thresholds (> 40). A concomitant COVID-19 infection likely did not contribute to his symptoms.    

Ventilation-perfusion mismatch is a well-recognized complication of pancreatitis, which results in right-to-left shunting.5 While we considered whether an intracardiac shunt may have contributed to the patient’s hypoxemia, a transthoracic echocardiogram with bubble contrast was negative.    

The patient had a peak serum triglyceride of > 6000 mg/dl, which meets the criteria for very severe hypertriglyceridemia.7 As observed in prior reports, the extent of the hypertriglyceridemia in this patient resulted in pronounced lipemic blood, which was appreciable by the eye and necessitated several rounds of centrifugation to analyze the laboratory studies.8 In this case, plasmapheresis was used to rapidly treat the hypertriglyceridemia, thereby reducing inflammation and further damage to the pancreas.9    

It is possible the patient’s hypertriglyceridemia may have been associated with his hypoxemia. His hypoxemia was most pronounced approximately 24 hours postadmission, which coincided with the peak of the hypertriglyceridemia. It remains unclear whether the severity of triglyceride elevation could accurately predict the severity of respiratory insufficiency. Hypoxemia is thought to modulate triglyceride metabolism through stimulation of intracellular lipolysis, upregulation of very low-density lipoproteins production in the liver, and inhibition of triglyceride-rich lipoprotein metabolism.10 Evidence from rodent studies supports the idea that acute hypoxemia increases triglycerides, and the degree of hypoxemia correlates with the elevated triglyceride levels.11 However, this has not been consistently observed in humans and may vary by prandial state.12,13 Thus, dysfunction of lipid metabolism may be a relevant clinical indicator of hypoxemia; further work is needed to elucidate this association.

Patient Perspective

The patient continues to undergo extensive rehabilitation following his prolonged illness and hospitalization. He expressed gratitude for the care received. However, he has limited and distorted recollection of the events during his hospitalization and stated that it felt “like an extraterrestrial state.”

Conclusions

This report describes a case of marked hypoxemia in the setting of acute pancreatitis. Pulmonary insufficiency in acute pancreatitis is commonly associated with imaging findings such as atelectasis, pleural effusions, and pulmonary infiltrates; however, up to half of cases initially lack any radiographic findings. Plasmapheresis is an effective treatment for hypertriglyceridemia-induced pancreatitis to both directly reduce circulating triglycerides and inflammation. Plasmapheresis also represents a promising therapy for the prevention of further episodes of pancreatitis in patients with recurrent pancreatitis. We propose a feedback mechanism through which pancreatitis induces severe hypoxemia, which may modulate lipid metabolism and severe hypertriglyceridemia correlates with respiratory failure.

References
  1. Zhou M-T, Chen C-S, Chen B-C, Zhang Q-Y, Andersson R. Acute lung injury and ARDS in acute pancreatitis: mechanisms and potential intervention. World J Gastroenterol. 2010;16(17):2094-2099. doi:10.3748/wjg.v16.i17.2094
  2. Peek GJ, White S, Scott AD, et al. Severe acute respiratory distress syndrome secondary to acute pancreatitis successfully treated with extracorporeal membrane oxygenation in three patients. Ann Surg. 1998;227(4):572-574. doi:10.1097/00000658-199804000-00020
  3. Searles GE, Ooi TC. Underrecognition of chylomicronemia as a cause of acute pancreatitis. Can Med Assoc J. 1992;147(12):1806-1808.
  4. de Pretis N, Amodio A, Frulloni L. Hypertriglyceridemic pancreatitis: Epidemiology, pathophysiology and clinical management. United European Gastroenterol J. 2018;6(5):649-655. doi:10.1177/2050640618755002
  5. Ranson JH, Turner JW, Roses DF, et al. Respiratory compli cations in acute pancreatitis. Ann Surg. 1974;179(5):557-566. doi:10.1097/00000658-197405000-00006 6. Swenson KE, Swenson ER. Pathophysiology of acute respiratory distress syndrome and COVID-19 lung injury. Crit Care Clin. 2021;37(4):749-776. doi:10.1016/j.ccc.2021.05.003
  6. Swenson KE, Swenson ER. Pathophysiology of acute respiratory distress syndrome and COVID- 19 lung injury. Crit Care Clin. 2021;37(4):749-776. doi:10.1016/j.ccc.2021.05.003
  7. Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(9):2969-2989. doi:10.1210/jc.2011-3213
  8. Ahern BJ, Yi HJ, Somma CL. Hypertriglyceridemia-induced pancreatitis and a lipemic blood sample: a case report and brief clinical review. J Emerg Nurs. 2022;48(4):455-459. doi:10.1016/j.jen.2022.02.001
  9. Garg R, Rustagi T. Management of hypertriglyceridemia induced acute pancreatitis. Biomed Res Int. 2018;2018:4721357. doi:10.1155/2018/4721357
  10. Morin R, Goulet N, Mauger J-F, Imbeault P. Physiological responses to hypoxia on triglyceride levels. Front Physiol. 2021;12:730935. doi:10.3389/fphys.2021.730935
  11. Jun JC, Shin M-K, Yao Q, et al. Acute hypoxia induces hypertriglyceridemia by decreasing plasma triglyceride clearance in mice. Am J Physiol Endocrinol Metab. 2012;303(3):E377-88. doi:10.1152/ajpendo.00641.2011
  12. Mahat B, Chassé É, Lindon C, Mauger J-F, Imbeault P. No effect of acute normobaric hypoxia on plasma triglyceride levels in fasting healthy men. Appl Physiol Nutr Metab. 2018;43(7):727-732. doi:10.1139/apnm-2017-0505
  13. Mauger J-F, Chassé É, Mahat B, Lindon C, Bordenave N, Imbeault P. The effect of acute continuous hypoxia on triglyceride levels in constantly fed healthy men. Front Physiol. 2019;10:752. doi:10.3389/fphys.2019.00752
References
  1. Zhou M-T, Chen C-S, Chen B-C, Zhang Q-Y, Andersson R. Acute lung injury and ARDS in acute pancreatitis: mechanisms and potential intervention. World J Gastroenterol. 2010;16(17):2094-2099. doi:10.3748/wjg.v16.i17.2094
  2. Peek GJ, White S, Scott AD, et al. Severe acute respiratory distress syndrome secondary to acute pancreatitis successfully treated with extracorporeal membrane oxygenation in three patients. Ann Surg. 1998;227(4):572-574. doi:10.1097/00000658-199804000-00020
  3. Searles GE, Ooi TC. Underrecognition of chylomicronemia as a cause of acute pancreatitis. Can Med Assoc J. 1992;147(12):1806-1808.
  4. de Pretis N, Amodio A, Frulloni L. Hypertriglyceridemic pancreatitis: Epidemiology, pathophysiology and clinical management. United European Gastroenterol J. 2018;6(5):649-655. doi:10.1177/2050640618755002
  5. Ranson JH, Turner JW, Roses DF, et al. Respiratory compli cations in acute pancreatitis. Ann Surg. 1974;179(5):557-566. doi:10.1097/00000658-197405000-00006 6. Swenson KE, Swenson ER. Pathophysiology of acute respiratory distress syndrome and COVID-19 lung injury. Crit Care Clin. 2021;37(4):749-776. doi:10.1016/j.ccc.2021.05.003
  6. Swenson KE, Swenson ER. Pathophysiology of acute respiratory distress syndrome and COVID- 19 lung injury. Crit Care Clin. 2021;37(4):749-776. doi:10.1016/j.ccc.2021.05.003
  7. Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(9):2969-2989. doi:10.1210/jc.2011-3213
  8. Ahern BJ, Yi HJ, Somma CL. Hypertriglyceridemia-induced pancreatitis and a lipemic blood sample: a case report and brief clinical review. J Emerg Nurs. 2022;48(4):455-459. doi:10.1016/j.jen.2022.02.001
  9. Garg R, Rustagi T. Management of hypertriglyceridemia induced acute pancreatitis. Biomed Res Int. 2018;2018:4721357. doi:10.1155/2018/4721357
  10. Morin R, Goulet N, Mauger J-F, Imbeault P. Physiological responses to hypoxia on triglyceride levels. Front Physiol. 2021;12:730935. doi:10.3389/fphys.2021.730935
  11. Jun JC, Shin M-K, Yao Q, et al. Acute hypoxia induces hypertriglyceridemia by decreasing plasma triglyceride clearance in mice. Am J Physiol Endocrinol Metab. 2012;303(3):E377-88. doi:10.1152/ajpendo.00641.2011
  12. Mahat B, Chassé É, Lindon C, Mauger J-F, Imbeault P. No effect of acute normobaric hypoxia on plasma triglyceride levels in fasting healthy men. Appl Physiol Nutr Metab. 2018;43(7):727-732. doi:10.1139/apnm-2017-0505
  13. Mauger J-F, Chassé É, Mahat B, Lindon C, Bordenave N, Imbeault P. The effect of acute continuous hypoxia on triglyceride levels in constantly fed healthy men. Front Physiol. 2019;10:752. doi:10.3389/fphys.2019.00752
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Federal Practitioner - 42(8)
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Federal Practitioner - 42(8)
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Profound Hypoxemia in a Patient With Hypertriglyceridemia-Induced Pancreatitis

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Profound Hypoxemia in a Patient With Hypertriglyceridemia-Induced Pancreatitis

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