Article

THE DIAGNOSIS: Black Dermographism

Black dermographism is characterized by asymptomatic black discoloration on the skin caused by contact with various metals, most commonly gold but also silver, nickel, zinc, lead, and aluminum.¹ These metallic particles have a black appearance as they do not reflect light.² Our patient was wearing gold hoop earrings at presentation, which were near the black patches. Certain topical products (eg, makeup, sunscreens [especially those containing zinc oxide or titanium oxide], toothpaste) can abrade metal, causing it to deposit on the skin and absorb light.³ The black discoloration is not permanent and can be prevented by avoiding contact between inciting products and metals.² No further diagnostic testing is necessary, and the patches will self-resolve if contact with the product is avoided.

Our patient noted that she wore a physical sunscreen daily, but the black patches were present only when she wore the gold hoop earrings. Given this history and physical examination findings in the office, it was suspected she had black dermographism due to her gold earrings and topical sunscreen. The patient was advised to avoid wearing the gold earrings.

Black dermographism is a misnomer because it is not a true urticarial reaction but rather a false dermographism; therefore, patients will not experience pruritus or erythema.¹ True dermographism is an inducible urticarial eruption from pressure or trauma to the skin. The clinical appearance is notable for erythematous wheals in the shape of the external force applied.⁴ Two other types of false dermographism include white dermographism, which occurs secondary to allergic contact dermatitis, and yellow dermographism, which is caused by bile deposits on the skin.⁴

Additional diagnoses were able to be ruled out for the following reasons: cutaneous mastocytosis can manifest with red-brown maculopapular lesions often accompanied by the Darier sign, which includes swelling, pruritus, and erythema but was not present in our patient.⁴ Allergic contact dermatitis manifests as a delayed eczematous reaction around 48 to 72 hours after exposure to an allergen. Our patient’s lesions formed while wearing gold earrings but did not manifest with a hypersensitivity reaction. Of note, symptomatic dermographism has been reported to mimic latex allergy.⁵ Ecchymosis may appear as erythematous, violaceous, or yellow-green patches depending on the stage but develops due to leakage from broken blood vessels secondary to trauma, which was not reported in our patient. Type I hypersensitivity reactions can occur minutes to hours after exposure to an allergen but typically manifest with a wheal-and-flare presentation.

Black dermographism from gold earrings can mimic concerning skin disorders or poor hygiene, causing unnecessary anxiety. Understanding that it is a harmless reaction between gold and certain topical products can reassure patients and prevent unnecessary testing or treatments.

THE DIAGNOSIS: Black Dermographism

Black dermographism is characterized by asymptomatic black discoloration on the skin caused by contact with various metals, most commonly gold but also silver, nickel, zinc, lead, and aluminum.¹ These metallic particles have a black appearance as they do not reflect light.² Our patient was wearing gold hoop earrings at presentation, which were near the black patches. Certain topical products (eg, makeup, sunscreens [especially those containing zinc oxide or titanium oxide], toothpaste) can abrade metal, causing it to deposit on the skin and absorb light.³ The black discoloration is not permanent and can be prevented by avoiding contact between inciting products and metals.² No further diagnostic testing is necessary, and the patches will self-resolve if contact with the product is avoided.

Our patient noted that she wore a physical sunscreen daily, but the black patches were present only when she wore the gold hoop earrings. Given this history and physical examination findings in the office, it was suspected she had black dermographism due to her gold earrings and topical sunscreen. The patient was advised to avoid wearing the gold earrings.

Black dermographism is a misnomer because it is not a true urticarial reaction but rather a false dermographism; therefore, patients will not experience pruritus or erythema.¹ True dermographism is an inducible urticarial eruption from pressure or trauma to the skin. The clinical appearance is notable for erythematous wheals in the shape of the external force applied.⁴ Two other types of false dermographism include white dermographism, which occurs secondary to allergic contact dermatitis, and yellow dermographism, which is caused by bile deposits on the skin.⁴

Additional diagnoses were able to be ruled out for the following reasons: cutaneous mastocytosis can manifest with red-brown maculopapular lesions often accompanied by the Darier sign, which includes swelling, pruritus, and erythema but was not present in our patient.⁴ Allergic contact dermatitis manifests as a delayed eczematous reaction around 48 to 72 hours after exposure to an allergen. Our patient’s lesions formed while wearing gold earrings but did not manifest with a hypersensitivity reaction. Of note, symptomatic dermographism has been reported to mimic latex allergy.⁵ Ecchymosis may appear as erythematous, violaceous, or yellow-green patches depending on the stage but develops due to leakage from broken blood vessels secondary to trauma, which was not reported in our patient. Type I hypersensitivity reactions can occur minutes to hours after exposure to an allergen but typically manifest with a wheal-and-flare presentation.

Black dermographism from gold earrings can mimic concerning skin disorders or poor hygiene, causing unnecessary anxiety. Understanding that it is a harmless reaction between gold and certain topical products can reassure patients and prevent unnecessary testing or treatments.

THE DIAGNOSIS: Black Dermographism

Black dermographism is characterized by asymptomatic black discoloration on the skin caused by contact with various metals, most commonly gold but also silver, nickel, zinc, lead, and aluminum.¹ These metallic particles have a black appearance as they do not reflect light.² Our patient was wearing gold hoop earrings at presentation, which were near the black patches. Certain topical products (eg, makeup, sunscreens [especially those containing zinc oxide or titanium oxide], toothpaste) can abrade metal, causing it to deposit on the skin and absorb light.³ The black discoloration is not permanent and can be prevented by avoiding contact between inciting products and metals.² No further diagnostic testing is necessary, and the patches will self-resolve if contact with the product is avoided.

Our patient noted that she wore a physical sunscreen daily, but the black patches were present only when she wore the gold hoop earrings. Given this history and physical examination findings in the office, it was suspected she had black dermographism due to her gold earrings and topical sunscreen. The patient was advised to avoid wearing the gold earrings.

Black dermographism is a misnomer because it is not a true urticarial reaction but rather a false dermographism; therefore, patients will not experience pruritus or erythema.¹ True dermographism is an inducible urticarial eruption from pressure or trauma to the skin. The clinical appearance is notable for erythematous wheals in the shape of the external force applied.⁴ Two other types of false dermographism include white dermographism, which occurs secondary to allergic contact dermatitis, and yellow dermographism, which is caused by bile deposits on the skin.⁴

Additional diagnoses were able to be ruled out for the following reasons: cutaneous mastocytosis can manifest with red-brown maculopapular lesions often accompanied by the Darier sign, which includes swelling, pruritus, and erythema but was not present in our patient.⁴ Allergic contact dermatitis manifests as a delayed eczematous reaction around 48 to 72 hours after exposure to an allergen. Our patient’s lesions formed while wearing gold earrings but did not manifest with a hypersensitivity reaction. Of note, symptomatic dermographism has been reported to mimic latex allergy.⁵ Ecchymosis may appear as erythematous, violaceous, or yellow-green patches depending on the stage but develops due to leakage from broken blood vessels secondary to trauma, which was not reported in our patient. Type I hypersensitivity reactions can occur minutes to hours after exposure to an allergen but typically manifest with a wheal-and-flare presentation.

Black dermographism from gold earrings can mimic concerning skin disorders or poor hygiene, causing unnecessary anxiety. Understanding that it is a harmless reaction between gold and certain topical products can reassure patients and prevent unnecessary testing or treatments.

THE DIAGNOSIS: Disseminate and Recurrent Infundibulofolliculitis

Histopathology demonstrated a lymphocyte-predominant infundibular infiltrate with mild spongiosis and lymphocytic exocytosis; a mild, superficial perivascular infiltrate also was present. The surrounding skin was largely normal with no notable papillomatosis, acanthosis, or hyperkeratosis (Figure 1). The clinical presentation and histopathologic findings led to the diagnosis of disseminate and recurrent infundibulofolliculitis (DRIF). The patient was started on a 2-week course of once-daily ammonium lactate lotion 12% and urea cream 40% and twice-daily triamcinolone ointment 0.1%. The patient was instructed to take a 1-week break before this regimen was repeated. Isotretinoin 0.5 mg/kg/d for 2 to 4 months was considered and will be an option if there is no improvement at follow-up.

Disseminate and recurrent infundibulofolliculitis is a rare noninfectious folliculitis that initially was described by Hitch and Lund¹ in 1968. Males of African descent are most commonly affected by DRIF, but the condition is not limited to this population.^2,3 It manifests as asymptomatic, flesh-colored, monomorphic, follicular papules distributed on the trunk and proximal extremities. Pustules can be present, and hair may be seen protruding from them. As the name suggests, DRIF is associated with histopathologic changes that are prominent at the infundibulum of hair follicles.^3,4 Disseminate and recurrent infundibulofolliculitis can persist for months to years because it often is resistant to treatment. Treatments include topical monotherapies such as corticosteroids, calcineurin inhibitors, or retinoids; combination topical treatments; antibiotics; and isotretinoin.² Recurrent remission and exacerbation occurs in many patients.³

The classic manifestations of DRIF, including follicular, monomorphic, flesh-colored papules distributed on the neck, trunk, and proximal upper extremities, were seen in our patient (Figure 2). These findings along with the skin biopsy identifying a lymphocytic infundibular infiltrate led to the diagnosis of DRIF. The papules associated with DRIF can be recurrent or chronic. The lesions in this patient were chronic and persistent.

Despite limited evidence, it has been suggested that DRIF may be a manifestation of atopic dermatitis in patients with darker skin tones. In our case, the patient had a history of childhood eczema. Other hypotheses have proposed that DRIF could be a nonspecific reaction to a currently unknown antigen. A causative infectious agent has not been identified, although the search continues. There is speculation that DRIF could be an overt expression of normal follicular prominence, but the presence of occasional pustules and lymphocyte- predominant infundibular infiltrate negates that.³

Confluent and reticulated papillomatosis was included in the differential for our patient and manifests as asymptomatic hyperpigmented papules and plaques frequently occurring on the upper trunk, neck, and axilla; however, these lesions have a peripheral netlike configuration, as the name suggests. Additionally, this condition is thought to have an infectious component (Dietzia papillomatosis) and responds to antibiotic treatment.⁵ Follicular eczema also was high in the differential diagnosis but usually is seasonal and pruritic, and histopathology typically shows the features of spongiotic dermatitis. It also would respond well to topical steroids.⁶ Another condition high on the differential was juxtaclavicular beaded lines, which also manifests as flesh-colored follicular papules distributed on the upper trunk; however, histopathology usually shows features of hyperplastic pilosebaceous units along with spongiosis and exocytosis.⁷ Pityrosporum folliculitis initially was considered, but the patient only endorsed occasional pruritus. Additionally, no fungal elements were observed.

Currently, there are no definitive treatments for DRIF. The topical treatments available include midpotency corticosteroids, tretinoin, calcineurin inhibitors, 12% lactic acid, and 20% to 40% urea. The systemic therapies are high-dose oral vitamin A (100,000 IU/d), isotretinoin, and psoralen plus UVA.^8-10

THE DIAGNOSIS: Disseminate and Recurrent Infundibulofolliculitis

Histopathology demonstrated a lymphocyte-predominant infundibular infiltrate with mild spongiosis and lymphocytic exocytosis; a mild, superficial perivascular infiltrate also was present. The surrounding skin was largely normal with no notable papillomatosis, acanthosis, or hyperkeratosis (Figure 1). The clinical presentation and histopathologic findings led to the diagnosis of disseminate and recurrent infundibulofolliculitis (DRIF). The patient was started on a 2-week course of once-daily ammonium lactate lotion 12% and urea cream 40% and twice-daily triamcinolone ointment 0.1%. The patient was instructed to take a 1-week break before this regimen was repeated. Isotretinoin 0.5 mg/kg/d for 2 to 4 months was considered and will be an option if there is no improvement at follow-up.

Disseminate and recurrent infundibulofolliculitis is a rare noninfectious folliculitis that initially was described by Hitch and Lund¹ in 1968. Males of African descent are most commonly affected by DRIF, but the condition is not limited to this population.^2,3 It manifests as asymptomatic, flesh-colored, monomorphic, follicular papules distributed on the trunk and proximal extremities. Pustules can be present, and hair may be seen protruding from them. As the name suggests, DRIF is associated with histopathologic changes that are prominent at the infundibulum of hair follicles.^3,4 Disseminate and recurrent infundibulofolliculitis can persist for months to years because it often is resistant to treatment. Treatments include topical monotherapies such as corticosteroids, calcineurin inhibitors, or retinoids; combination topical treatments; antibiotics; and isotretinoin.² Recurrent remission and exacerbation occurs in many patients.³

The classic manifestations of DRIF, including follicular, monomorphic, flesh-colored papules distributed on the neck, trunk, and proximal upper extremities, were seen in our patient (Figure 2). These findings along with the skin biopsy identifying a lymphocytic infundibular infiltrate led to the diagnosis of DRIF. The papules associated with DRIF can be recurrent or chronic. The lesions in this patient were chronic and persistent.

Despite limited evidence, it has been suggested that DRIF may be a manifestation of atopic dermatitis in patients with darker skin tones. In our case, the patient had a history of childhood eczema. Other hypotheses have proposed that DRIF could be a nonspecific reaction to a currently unknown antigen. A causative infectious agent has not been identified, although the search continues. There is speculation that DRIF could be an overt expression of normal follicular prominence, but the presence of occasional pustules and lymphocyte- predominant infundibular infiltrate negates that.³

Confluent and reticulated papillomatosis was included in the differential for our patient and manifests as asymptomatic hyperpigmented papules and plaques frequently occurring on the upper trunk, neck, and axilla; however, these lesions have a peripheral netlike configuration, as the name suggests. Additionally, this condition is thought to have an infectious component (Dietzia papillomatosis) and responds to antibiotic treatment.⁵ Follicular eczema also was high in the differential diagnosis but usually is seasonal and pruritic, and histopathology typically shows the features of spongiotic dermatitis. It also would respond well to topical steroids.⁶ Another condition high on the differential was juxtaclavicular beaded lines, which also manifests as flesh-colored follicular papules distributed on the upper trunk; however, histopathology usually shows features of hyperplastic pilosebaceous units along with spongiosis and exocytosis.⁷ Pityrosporum folliculitis initially was considered, but the patient only endorsed occasional pruritus. Additionally, no fungal elements were observed.

Currently, there are no definitive treatments for DRIF. The topical treatments available include midpotency corticosteroids, tretinoin, calcineurin inhibitors, 12% lactic acid, and 20% to 40% urea. The systemic therapies are high-dose oral vitamin A (100,000 IU/d), isotretinoin, and psoralen plus UVA.^8-10

THE DIAGNOSIS: Disseminate and Recurrent Infundibulofolliculitis

Histopathology demonstrated a lymphocyte-predominant infundibular infiltrate with mild spongiosis and lymphocytic exocytosis; a mild, superficial perivascular infiltrate also was present. The surrounding skin was largely normal with no notable papillomatosis, acanthosis, or hyperkeratosis (Figure 1). The clinical presentation and histopathologic findings led to the diagnosis of disseminate and recurrent infundibulofolliculitis (DRIF). The patient was started on a 2-week course of once-daily ammonium lactate lotion 12% and urea cream 40% and twice-daily triamcinolone ointment 0.1%. The patient was instructed to take a 1-week break before this regimen was repeated. Isotretinoin 0.5 mg/kg/d for 2 to 4 months was considered and will be an option if there is no improvement at follow-up.

Disseminate and recurrent infundibulofolliculitis is a rare noninfectious folliculitis that initially was described by Hitch and Lund¹ in 1968. Males of African descent are most commonly affected by DRIF, but the condition is not limited to this population.^2,3 It manifests as asymptomatic, flesh-colored, monomorphic, follicular papules distributed on the trunk and proximal extremities. Pustules can be present, and hair may be seen protruding from them. As the name suggests, DRIF is associated with histopathologic changes that are prominent at the infundibulum of hair follicles.^3,4 Disseminate and recurrent infundibulofolliculitis can persist for months to years because it often is resistant to treatment. Treatments include topical monotherapies such as corticosteroids, calcineurin inhibitors, or retinoids; combination topical treatments; antibiotics; and isotretinoin.² Recurrent remission and exacerbation occurs in many patients.³

The classic manifestations of DRIF, including follicular, monomorphic, flesh-colored papules distributed on the neck, trunk, and proximal upper extremities, were seen in our patient (Figure 2). These findings along with the skin biopsy identifying a lymphocytic infundibular infiltrate led to the diagnosis of DRIF. The papules associated with DRIF can be recurrent or chronic. The lesions in this patient were chronic and persistent.

Despite limited evidence, it has been suggested that DRIF may be a manifestation of atopic dermatitis in patients with darker skin tones. In our case, the patient had a history of childhood eczema. Other hypotheses have proposed that DRIF could be a nonspecific reaction to a currently unknown antigen. A causative infectious agent has not been identified, although the search continues. There is speculation that DRIF could be an overt expression of normal follicular prominence, but the presence of occasional pustules and lymphocyte- predominant infundibular infiltrate negates that.³

Confluent and reticulated papillomatosis was included in the differential for our patient and manifests as asymptomatic hyperpigmented papules and plaques frequently occurring on the upper trunk, neck, and axilla; however, these lesions have a peripheral netlike configuration, as the name suggests. Additionally, this condition is thought to have an infectious component (Dietzia papillomatosis) and responds to antibiotic treatment.⁵ Follicular eczema also was high in the differential diagnosis but usually is seasonal and pruritic, and histopathology typically shows the features of spongiotic dermatitis. It also would respond well to topical steroids.⁶ Another condition high on the differential was juxtaclavicular beaded lines, which also manifests as flesh-colored follicular papules distributed on the upper trunk; however, histopathology usually shows features of hyperplastic pilosebaceous units along with spongiosis and exocytosis.⁷ Pityrosporum folliculitis initially was considered, but the patient only endorsed occasional pruritus. Additionally, no fungal elements were observed.

Currently, there are no definitive treatments for DRIF. The topical treatments available include midpotency corticosteroids, tretinoin, calcineurin inhibitors, 12% lactic acid, and 20% to 40% urea. The systemic therapies are high-dose oral vitamin A (100,000 IU/d), isotretinoin, and psoralen plus UVA.^8-10

The Public Health and Welfare Act of 1988 prohibited the use of federal funds to “provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs.”¹ Although the Act included the caveat that the US Surgeon General may determine that “a demonstration needle exchange program would be effective in reducing drug abuse,” and thus federal funds could be used, the legislation prohibited federal, state, and local agencies from funding syringe services programs (SSPs). SSPs use various harm reduction tools to improve public safety and reduce the potential harmful consequences of risky behaviors, similar to how using a seat belt while driving reduces the risk of injury or death.² SSPs are rooted in evidence-based practices, and several studies, according to the Centers for Disease Control and Prevention, have found that people who use drugs (PWUDs) who use community-based SSPs are 5 times more likely to enter treatment than those who do not use these programs. Additionally, these programs have shown an estimated 50% reduction in HIV and hepatitis C infections.³

Amid a 2015 HIV outbreak in Indiana among individuals sharing needles for injection drug use, Congress passed an omnibus spending bill that partially lifted the federal funding restriction. Federal funds now may be used for operational costs that support SSPs but may not be used to purchase syringes themselves.⁴

Following the 2015 legislation, federal agencies began implementing SSPs. The Veterans Health Administration (VHA) established SSPs at 3 medical centers in 2017.⁵ Veterans who participated in the programs were able to access supplies (eg, syringes, fentanyl test strips, wound care kits, and condoms) through donations to US Department of Veterans Affairs (VA) medical centers (VAMCs). The success of these programs laid the foundation for the VHA to implement SSPs nationally. VHA SSPs provided access to naloxone (an opioid overdose reversal medication), fentanyl test strips, condoms, sterile syringe distribution, testing for blood-borne viruses, HIV pre-exposure prophylaxis, as well as educational materials and resources, and low-barrier access to drug treatment (eg, medications for opioid use disorder [OUD]).

In 2020, the Biden Administration outlined 7 drug policy priorities, which included enhancing evidence-based harm reduction efforts. ⁶ This policy also discussed mandates for federal agencies to remove barriers to federal funding for purchasing syringes and other harm reduction supplies. The VHA responded to the policy by publishing guidance that recommended VAMCs develop and/or ensure veterans have access to harm reduction services in the community, where state law is not legally more stringent.⁷

In 2025 the Trump administration Statement of Drug Policy Priorities encouraged local jurisdictions to increase the availability of drug test strips and naloxone.⁸ These significant policy shifts moved SSPs from being housed mostly in local public health departments and community-based organizations to also being available at health care facilities. ⁹ VAMCs have unique opportunities to provide universal health care that includes both prevention services and other medical management to PWUD.

One study assessed staff perceptions of PWUD at a VAMC in preparation for a training program about harm reduction. The results indicated an overall positive staff perception of PWUD, although only the Drug and Drug Problems Perceptions Questionnaire (DDPPQ) was administered, which assessed comfort of working with this population and not explicitly the use of harm reduction.¹⁰ Another study interviewed clinical pharmacists, primary care clinicians, social workers, and directors of addiction and mental health services to determine barriers and facilitators (ie, potential opportunities to promote change) to implementing harm reduction at the VHA. The study identified barriers to be a lack of knowledge, time, and comfort, while suggesting opportunities for improvement were engagement of champions, communication and educational strategies, and adaptation of existing infrastructure.¹¹

While these findings are insightful for the VHA to disseminate a harm reduction program, there remains a gap in assessing staff willingness to provide harm reduction services. Evidence on harm reduction services among veterans is limited and more research is needed to better understand the role of these services and acceptance among enrolled veterans and VHA staff. Specifically, more research is needed on health care practitioners’ (HCPs) perceptions of harm reduction use.

Mental health care practitioners frequently treat patients with substance use disorders (SUDs), making them an ideal initial cohort to assess willingness to provide harm reduction to this population. By analyzing mental HCPs’ perceptions, additional interventions could be identified, implemented, and evaluated to improve their willingness to provide harm reduction tools.

This project focused on mental health clinicians with prescribing privileges: physicians (allopathic and osteopathic physicians), nurse practitioners, physician assistants, and clinical pharmacist practitioners. Mental health prescribers were selected because they are uniquely positioned at the intersection of prevention and treatment in drug use. Furthermore, mental health prescribers at the VAMCs included in this study are usually the primary point of entry to SUD clinics. This mixed-methods study used an anonymous online survey and voluntary postsurvey discussions with mental health care prescribers to elaborate on their beliefs and attitudes, providing deeper insight into their responses regarding harm reduction.

Methods

This project was conducted by the Veterans Integrated Services Network (VISN) 5 academic detailing team. VISN 5 serves veterans from economically and demographically diverse areas in Maryland; Washington, DC; West Virginia; and portions of Virginia, Pennsylvania, Ohio, and Kentucky. VAMCs in Baltimore, Maryland, and Washington, DC, serve a largely urban population while the 4 West Virginia facilities in Martinsburg, Huntington, Beckley, and Clarksburg, serve a largely rural population. West Virginia has been the epicenter of the opioid crisis and consistently has the highest drug overdose deaths per capita in the United States.¹² Among cities, Baltimore, Maryland, has the highest number of drug overdose deaths per capita with 174.1 per 100,000 people.^12,13

At the time of this project, the 6 VISN 5 VAMCs had established overdose education and naloxone distribution (OEND) programs. Although OEND programs have existed since 2013, VISN 5 SSPs and harm reduction services that provided fentanyl test strips were only available at the Martinsburg, Beckley, and Huntington VAMCs. All 6 VAMCs had substance use treatment programs with a variety of inpatient and outpatient mental health services. The Washington, DC and Baltimore VAMCs had opioid treatment programs that provided methadone maintenance.

The VISN 5 academic detailing team consists of 7 clinical pharmacists. These academic detailers plan annual systematic interventions to provide medical knowledge translation services on health-related campaigns. Academic detailers are trained in change management and motivational interviewing. They uniquely facilitate conversations with HCPs on various topics or campaigns, aiming for quality improvement and behavioral change through positive relationships and sharing resources.¹⁴ Academic detailing conversations and relationships with HCPs involve assessing and understanding HCP behaviors, including barriers and readiness to change to align with the goal of improving patient outcomes. Academic detailing has improved practice behaviors around providing OEND in VHA.¹⁵

To prepare for a harm reduction campaign, the academic detailers sought to gain insight from target VISN 5 mental health prescribers. Figure 1 outlines the project timeline, which started with emails inviting mental health prescribers to complete an anonymous online survey. Academic detailers from each site emailed mental health prescribers who completed the survey to determine interest in expanding on survey findings. Mental health prescribers who completed the survey could participate in a postsurvey discussion.

Surveys

Between January 29, 2024, and February 22, 2024, the academic detailers emailed facility mental health prescribers (N = 156) a link to an anonymous 15-question survey. The email informed recipients of the survey’s purpose: to gain a better understanding of prescriber perceptions of veterans with SUD and harm reduction programs and their willingness to provide harm reduction tools, to better determine interventions that could be implemented.

The survey collected prescriber demographic data and their perceptions of PWUD and harm reduction tools and education. Survey questions were extrapolated from validated surveys (eg, DDPPQ) and survey-based implicit association test.^16,17 The survey used multiple choice and 5-point Likert scale questions. Mental health prescribers were asked about their role at the VHA, years in practice, medical center affiliation, type of SUDs treated (eg, opioid, stimulant, alcohol, cannabis, or other), and whether they had previously met with academic detailers about harm reduction.

Respondents read statements about patients with or without SUD and provided Likert scale responses describing their regard, level of comfort, and preferences. The survey included Likert scale questions about respondents’ comfort in providing harm reduction education and supplies. Respondents also noted whether they believed harm reduction reduced substance use, harm reduction tools encourage people with SUD to continue using drugs, and whether HCPs can impact clinical change.

Postsurvey interviews with predetermined questions were conducted in-person or via video conference with ≥ 1 prescriber at each VAMC by an academic detailer. The postsurvey discussion offered an opportunity for respondents to further elaborate and describe previous experiences and current beliefs that may affect their attitudes toward people with SUD and their views on harm reduction. Participants received no compensation for survey completion or interviews.

Analysis

The Washington VAMC Institutional Review Board reviewed and approved this project as quality improvement with potential publication. No inferential statistics were calculated. Survey participant demographics were reported using frequencies and proportions reported for categorical variables. Notes from follow-up interviews were analyzed using the Prosci Awareness, Desire, Knowledge, Ability, and Reinforcement (ADKAR) Model for Change Management.¹⁸ This framework is used by academic detailers to determine a prescriber’s stage of change, which helps select the appropriate resources to move the clinician along a change framework. Completed postsurvey interview sheets, including notes written by the academic detailer, were analyzed by the project lead (NJ) who reviewed each interview sheet and analysis with the academic detailer who led the discussion.

Results

Sixty-six respondents completed the online survey (42% response rate), and 7 mental health prescribers participated in a postsurvey discussion. Thirty-one participants (47%) were physicians and 17 (26%) were in practice for > 20 years. Response rates reflected the size of mental health staff at each VAMC at the time of the survey: 17 respondents (26%) worked at each of the Martinsburg and Baltimore VAMCs, with fewer at the other VAMCs (Table 1). Alcohol use disorder was the most commonly reported SUD treated (n = 62; 33%), followed by cannabis use disorder (n = 40; 21%), OUD (n = 38; 20%), and stimulant use disorder (n = 37; 20%).

Respondents felt comfortable and confident educating patients on ways to reduce harm related to substance use (91%; mean [SD], 4.24 [0.84]). Most prescribers surveyed (97%; mean [SD], 1.59 [0.68]) disagreed or strongly disagreed that harm reduction encourages patients with SUD to continue using drugs, and all prescribers surveyed disagreed that there is nothing they can do to encourage harm reduction. Survey results were mixed for personal comfort in working with people with SUD vs people without SUD (Figure 2). Respondents were most willing to provide naloxone (95%; mean [SD], 4.71 [0.78]), compared to fentanyl test strips (61%; mean [SD], 3.61 [1.41]) or syringes (39%; mean [SD], 3.18 [1.39]). Respondents were neutral or least willing to provide syringes (Figure 3).

Seven postsurvey interviews were completed between academic detailers and mental health clinicians across the 6 VAMCs. Respondents included 1 physician assistant, 1 nurse practitioner, 1 pharmacist, and 4 physicians. Notes were analyzed using the ADKAR Change Competency Model to organize clinician stages of change (Table 2).

Barriers identified by interviewees included lack of mobile services, lack of confidence and awareness of the availability of harm reduction at their respective medical center, lack of time to discuss harm reduction, negative sentiments toward providing SUD-related harm reduction, discomfort with harm reduction products, and lack of knowledge and time to learn about harm reduction services. Opportunities identified to drive change in practice included additional time allotted during patient appointments, educational discussions and presentations to increase knowledge of and comfort with harm reduction tools, a clear clinical patient care workflow and process for harm reduction services, and reinforcement strategies to recognize success.

Discussion

This project investigated mental health prescribers’ perceptions of harm reduction at VAMCs in West Virginia, Maryland, and Washington, DC. While previous studies have demonstrated the efficacy of harm reduction tools, there is a lack of research on HCPs willingness to use these resources. This study suggests that while most respondents feel confident in and see the value of offering harm reduction resources to patients, a disparity exists between which resources HCPs are more likely to use and factors that would further enhance their ability to integrate harm reduction into practice. The follow-up interviews provided additional insight into the survey results.

Most respondents met the awareness and desire stage and moved to the knowledge, ability, or reinforcement ADKAR stage. It would be reasonable to extrapolate that most of the respondents felt comfortable with and were very likely to offer certain harm reduction tools. In the ADKAR interview analysis, the most common factors needed to drive change included having more time during patient appointments, additional education, clear processes for harm reduction services, and reinforcement strategies to sustain change. Respondents noted that harm reduction discussions took extra time in their already limited appointments with patients, which may have limited time for discussions surrounding all other mental health concerns. These discussions often necessitate in-depth conversations to accurately understand the patients’ needs. Given HCP time constraints, they may view harm reduction as lower in urgency and priority relative to other concerns. While most respondents were in the reinforcement phase, it is important to note the ADKAR model is fluid, and therefore an HCP could move forward or backward. This movement can be noted in the postsurvey interviews where, for example, prescriber 6 was determined to be in the reinforcement stage since they had already discussed harm reduction with patients. However, prescriber 6 also noted a barrier of unfamiliarity with local laws, which could shift them to the ADKAR knowledge stage.

Respondents noted that education through didactic sessions could lead to better incorporation of harm reduction into patient care. While harm reduction has evidence supporting its effectiveness, the respondents noted willingness to discuss harm reduction when treatment fails or the patient refuses treatment or referrals. Respondents expressed mixed opinions on use of harm reduction tools among patients with SUDs as some prescribers viewed harm reduction as part of a treatment plan and others viewed a return to drug use as a failure of treatment. Furthermore, respondents expressed hesitancy surrounding certain harm reduction tools, such as fentanyl test strips or syringes, and perceived these supplies as intended for medical use rather than harm reduction. HCPs may feel uncomfortable offering these supplies for drug use, despite their use for reducing risk.

Most responses were received from VAMCs with large mental health substance use programs. Respondents at larger, urban facilities (Washington, DC, and Baltimore, Maryland) expressed more hesitancy around using harm reduction tools despite having more harm reduction resources available compared to smaller or rural sites. These results align with previous studies that found no difference in prescribers providing medications for OUD in rural and urban VAMCs, showing urban sites, despite more resources, are not more willing to provide harm reduction or other addiction services.¹⁹ This evidence might indicate that urban sites may not use available resources (eg, methadone clinics) or that rural sites can provide just as robust medications for OUD care as urban sites.

Follow-up interview analysis indicated that HCPs lack knowledge of certain harm reduction tools. One-on-one peer discussions, like academic detailing, can facilitate discussions around a prescriber’s role in harm reduction, address gaps in knowledge by sharing what is available at the facilities for harm reduction, and suggest conversation points to help prescribers start harm reduction discussions with patients unwilling to begin treatment. Additionally, academic detailing can connect prescribers to available resources in the community to provide pragmatic approaches and suggestions. A clear and consistent treatment process may reduce barriers by reassuring prescribers they have support and by providing consistent directions so that prescribers do not waste time.

Reinforcement is important for sustaining change. VAMCs could consider positive feedback and other evidence-based reinforcement strategies (eg, social recognition, continuing education) to communicate that these changes are noticed and appreciated.²⁰ Late adopters may also be influenced by seeing positive feedback and results for peers. Systematic changes can be the catalyst for and sustain individual change.

Shifting perceptions and adopting change may be challenging, especially for SUD, which can be highly stigmatized. Promotion of successful change should be multifaceted and include both system and individual approaches. VHA systemic changes that could contribute to positive change include provision of time and access to SUD treatment training, a clear and sustainable treatment process, and reinforcement by recognizing success. In addition, facility leadership could provide support through dedicated time and resources during the workday for SUD treatment and harm reduction training. Support could empower HCPs and convey leadership support for harm reduction. This dedicated time could be used for didactic lecture sessions or individual meetings with academic detailers who can tailor discussions to the prescriber’s practice.

Strengths and Limitations

This survey included prescribers from a range of mental health care practice settings (eg, inpatient, outpatient clinic, rural, urban) and varied years of experience. This variety resulted in diverse perspectives and knowledge bases. Postsurvey interviews allowed academic detailers to gain deeper insight into answers in the survey, which can guide future interventions. Postsurvey interviews and application of the ADKAR model provided additional viewpoints on harm reduction.

A limitation of this project is the absence of an assessment of respondents’ harm reduction knowledge accuracy. Although respondents reported confidence in discussing harm reduction with patients, the survey did not assess whether their knowledge was accurate. Additionally, the survey did not ask about the availability of syringes and test strips at the prescribers’ VAMC, which could explain discrepancies in responses between naloxone and other forms of harm reduction (drug test strips and syringes were not available to all HCPs in the VISN). This lack of availability may have skewed responses. West Virginia SSPs, for example, were closed following legislative changes, which may contribute to stigma.²¹

Not all respondents were asked to do a follow-up interview, which limited the perspectives included in this study. Each site had ≥ 1 follow-up interview to limit the academic detailer’s workload. The initial survey included the phrase clean syringe, which can be stigmatizing and insinuate that PWUD are not clean. The preferred term would have been sterile syringe.²²

Conclusions

This survey of mental health prescribers found that most respondents are comfortable treating patients with SUD and confident in educating patients on harm reduction. Additionally, most respondents were more willing to provide naloxone vs fentanyl test strips or sterile syringes. A lack of time and awareness was the most frequently cited barrier to harm reduction services. As the VHA continues to expand access to harm reduction programs, which have proven to increase treatment rates and reduce disease, it will be imperative for HCPs, including mental health prescribers, to recognize the benefit of these programs for veterans with SUD. Future interventions should be designed and evaluated in collaboration with all HCPs and patients. This project determined ways to promote change for prescribers, but it will be important for further research to continue those conversations and incorporate patient perspectives.

The Public Health and Welfare Act of 1988 prohibited the use of federal funds to “provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs.”¹ Although the Act included the caveat that the US Surgeon General may determine that “a demonstration needle exchange program would be effective in reducing drug abuse,” and thus federal funds could be used, the legislation prohibited federal, state, and local agencies from funding syringe services programs (SSPs). SSPs use various harm reduction tools to improve public safety and reduce the potential harmful consequences of risky behaviors, similar to how using a seat belt while driving reduces the risk of injury or death.² SSPs are rooted in evidence-based practices, and several studies, according to the Centers for Disease Control and Prevention, have found that people who use drugs (PWUDs) who use community-based SSPs are 5 times more likely to enter treatment than those who do not use these programs. Additionally, these programs have shown an estimated 50% reduction in HIV and hepatitis C infections.³

Amid a 2015 HIV outbreak in Indiana among individuals sharing needles for injection drug use, Congress passed an omnibus spending bill that partially lifted the federal funding restriction. Federal funds now may be used for operational costs that support SSPs but may not be used to purchase syringes themselves.⁴

Following the 2015 legislation, federal agencies began implementing SSPs. The Veterans Health Administration (VHA) established SSPs at 3 medical centers in 2017.⁵ Veterans who participated in the programs were able to access supplies (eg, syringes, fentanyl test strips, wound care kits, and condoms) through donations to US Department of Veterans Affairs (VA) medical centers (VAMCs). The success of these programs laid the foundation for the VHA to implement SSPs nationally. VHA SSPs provided access to naloxone (an opioid overdose reversal medication), fentanyl test strips, condoms, sterile syringe distribution, testing for blood-borne viruses, HIV pre-exposure prophylaxis, as well as educational materials and resources, and low-barrier access to drug treatment (eg, medications for opioid use disorder [OUD]).

In 2020, the Biden Administration outlined 7 drug policy priorities, which included enhancing evidence-based harm reduction efforts. ⁶ This policy also discussed mandates for federal agencies to remove barriers to federal funding for purchasing syringes and other harm reduction supplies. The VHA responded to the policy by publishing guidance that recommended VAMCs develop and/or ensure veterans have access to harm reduction services in the community, where state law is not legally more stringent.⁷

In 2025 the Trump administration Statement of Drug Policy Priorities encouraged local jurisdictions to increase the availability of drug test strips and naloxone.⁸ These significant policy shifts moved SSPs from being housed mostly in local public health departments and community-based organizations to also being available at health care facilities. ⁹ VAMCs have unique opportunities to provide universal health care that includes both prevention services and other medical management to PWUD.

One study assessed staff perceptions of PWUD at a VAMC in preparation for a training program about harm reduction. The results indicated an overall positive staff perception of PWUD, although only the Drug and Drug Problems Perceptions Questionnaire (DDPPQ) was administered, which assessed comfort of working with this population and not explicitly the use of harm reduction.¹⁰ Another study interviewed clinical pharmacists, primary care clinicians, social workers, and directors of addiction and mental health services to determine barriers and facilitators (ie, potential opportunities to promote change) to implementing harm reduction at the VHA. The study identified barriers to be a lack of knowledge, time, and comfort, while suggesting opportunities for improvement were engagement of champions, communication and educational strategies, and adaptation of existing infrastructure.¹¹

While these findings are insightful for the VHA to disseminate a harm reduction program, there remains a gap in assessing staff willingness to provide harm reduction services. Evidence on harm reduction services among veterans is limited and more research is needed to better understand the role of these services and acceptance among enrolled veterans and VHA staff. Specifically, more research is needed on health care practitioners’ (HCPs) perceptions of harm reduction use.

Mental health care practitioners frequently treat patients with substance use disorders (SUDs), making them an ideal initial cohort to assess willingness to provide harm reduction to this population. By analyzing mental HCPs’ perceptions, additional interventions could be identified, implemented, and evaluated to improve their willingness to provide harm reduction tools.

This project focused on mental health clinicians with prescribing privileges: physicians (allopathic and osteopathic physicians), nurse practitioners, physician assistants, and clinical pharmacist practitioners. Mental health prescribers were selected because they are uniquely positioned at the intersection of prevention and treatment in drug use. Furthermore, mental health prescribers at the VAMCs included in this study are usually the primary point of entry to SUD clinics. This mixed-methods study used an anonymous online survey and voluntary postsurvey discussions with mental health care prescribers to elaborate on their beliefs and attitudes, providing deeper insight into their responses regarding harm reduction.

Methods

This project was conducted by the Veterans Integrated Services Network (VISN) 5 academic detailing team. VISN 5 serves veterans from economically and demographically diverse areas in Maryland; Washington, DC; West Virginia; and portions of Virginia, Pennsylvania, Ohio, and Kentucky. VAMCs in Baltimore, Maryland, and Washington, DC, serve a largely urban population while the 4 West Virginia facilities in Martinsburg, Huntington, Beckley, and Clarksburg, serve a largely rural population. West Virginia has been the epicenter of the opioid crisis and consistently has the highest drug overdose deaths per capita in the United States.¹² Among cities, Baltimore, Maryland, has the highest number of drug overdose deaths per capita with 174.1 per 100,000 people.^12,13

At the time of this project, the 6 VISN 5 VAMCs had established overdose education and naloxone distribution (OEND) programs. Although OEND programs have existed since 2013, VISN 5 SSPs and harm reduction services that provided fentanyl test strips were only available at the Martinsburg, Beckley, and Huntington VAMCs. All 6 VAMCs had substance use treatment programs with a variety of inpatient and outpatient mental health services. The Washington, DC and Baltimore VAMCs had opioid treatment programs that provided methadone maintenance.

The VISN 5 academic detailing team consists of 7 clinical pharmacists. These academic detailers plan annual systematic interventions to provide medical knowledge translation services on health-related campaigns. Academic detailers are trained in change management and motivational interviewing. They uniquely facilitate conversations with HCPs on various topics or campaigns, aiming for quality improvement and behavioral change through positive relationships and sharing resources.¹⁴ Academic detailing conversations and relationships with HCPs involve assessing and understanding HCP behaviors, including barriers and readiness to change to align with the goal of improving patient outcomes. Academic detailing has improved practice behaviors around providing OEND in VHA.¹⁵

To prepare for a harm reduction campaign, the academic detailers sought to gain insight from target VISN 5 mental health prescribers. Figure 1 outlines the project timeline, which started with emails inviting mental health prescribers to complete an anonymous online survey. Academic detailers from each site emailed mental health prescribers who completed the survey to determine interest in expanding on survey findings. Mental health prescribers who completed the survey could participate in a postsurvey discussion.

Surveys

Between January 29, 2024, and February 22, 2024, the academic detailers emailed facility mental health prescribers (N = 156) a link to an anonymous 15-question survey. The email informed recipients of the survey’s purpose: to gain a better understanding of prescriber perceptions of veterans with SUD and harm reduction programs and their willingness to provide harm reduction tools, to better determine interventions that could be implemented.

The survey collected prescriber demographic data and their perceptions of PWUD and harm reduction tools and education. Survey questions were extrapolated from validated surveys (eg, DDPPQ) and survey-based implicit association test.^16,17 The survey used multiple choice and 5-point Likert scale questions. Mental health prescribers were asked about their role at the VHA, years in practice, medical center affiliation, type of SUDs treated (eg, opioid, stimulant, alcohol, cannabis, or other), and whether they had previously met with academic detailers about harm reduction.

Respondents read statements about patients with or without SUD and provided Likert scale responses describing their regard, level of comfort, and preferences. The survey included Likert scale questions about respondents’ comfort in providing harm reduction education and supplies. Respondents also noted whether they believed harm reduction reduced substance use, harm reduction tools encourage people with SUD to continue using drugs, and whether HCPs can impact clinical change.

Postsurvey interviews with predetermined questions were conducted in-person or via video conference with ≥ 1 prescriber at each VAMC by an academic detailer. The postsurvey discussion offered an opportunity for respondents to further elaborate and describe previous experiences and current beliefs that may affect their attitudes toward people with SUD and their views on harm reduction. Participants received no compensation for survey completion or interviews.

Analysis

The Washington VAMC Institutional Review Board reviewed and approved this project as quality improvement with potential publication. No inferential statistics were calculated. Survey participant demographics were reported using frequencies and proportions reported for categorical variables. Notes from follow-up interviews were analyzed using the Prosci Awareness, Desire, Knowledge, Ability, and Reinforcement (ADKAR) Model for Change Management.¹⁸ This framework is used by academic detailers to determine a prescriber’s stage of change, which helps select the appropriate resources to move the clinician along a change framework. Completed postsurvey interview sheets, including notes written by the academic detailer, were analyzed by the project lead (NJ) who reviewed each interview sheet and analysis with the academic detailer who led the discussion.

Results

Sixty-six respondents completed the online survey (42% response rate), and 7 mental health prescribers participated in a postsurvey discussion. Thirty-one participants (47%) were physicians and 17 (26%) were in practice for > 20 years. Response rates reflected the size of mental health staff at each VAMC at the time of the survey: 17 respondents (26%) worked at each of the Martinsburg and Baltimore VAMCs, with fewer at the other VAMCs (Table 1). Alcohol use disorder was the most commonly reported SUD treated (n = 62; 33%), followed by cannabis use disorder (n = 40; 21%), OUD (n = 38; 20%), and stimulant use disorder (n = 37; 20%).

Respondents felt comfortable and confident educating patients on ways to reduce harm related to substance use (91%; mean [SD], 4.24 [0.84]). Most prescribers surveyed (97%; mean [SD], 1.59 [0.68]) disagreed or strongly disagreed that harm reduction encourages patients with SUD to continue using drugs, and all prescribers surveyed disagreed that there is nothing they can do to encourage harm reduction. Survey results were mixed for personal comfort in working with people with SUD vs people without SUD (Figure 2). Respondents were most willing to provide naloxone (95%; mean [SD], 4.71 [0.78]), compared to fentanyl test strips (61%; mean [SD], 3.61 [1.41]) or syringes (39%; mean [SD], 3.18 [1.39]). Respondents were neutral or least willing to provide syringes (Figure 3).

Seven postsurvey interviews were completed between academic detailers and mental health clinicians across the 6 VAMCs. Respondents included 1 physician assistant, 1 nurse practitioner, 1 pharmacist, and 4 physicians. Notes were analyzed using the ADKAR Change Competency Model to organize clinician stages of change (Table 2).

Barriers identified by interviewees included lack of mobile services, lack of confidence and awareness of the availability of harm reduction at their respective medical center, lack of time to discuss harm reduction, negative sentiments toward providing SUD-related harm reduction, discomfort with harm reduction products, and lack of knowledge and time to learn about harm reduction services. Opportunities identified to drive change in practice included additional time allotted during patient appointments, educational discussions and presentations to increase knowledge of and comfort with harm reduction tools, a clear clinical patient care workflow and process for harm reduction services, and reinforcement strategies to recognize success.

Discussion

This project investigated mental health prescribers’ perceptions of harm reduction at VAMCs in West Virginia, Maryland, and Washington, DC. While previous studies have demonstrated the efficacy of harm reduction tools, there is a lack of research on HCPs willingness to use these resources. This study suggests that while most respondents feel confident in and see the value of offering harm reduction resources to patients, a disparity exists between which resources HCPs are more likely to use and factors that would further enhance their ability to integrate harm reduction into practice. The follow-up interviews provided additional insight into the survey results.

Most respondents met the awareness and desire stage and moved to the knowledge, ability, or reinforcement ADKAR stage. It would be reasonable to extrapolate that most of the respondents felt comfortable with and were very likely to offer certain harm reduction tools. In the ADKAR interview analysis, the most common factors needed to drive change included having more time during patient appointments, additional education, clear processes for harm reduction services, and reinforcement strategies to sustain change. Respondents noted that harm reduction discussions took extra time in their already limited appointments with patients, which may have limited time for discussions surrounding all other mental health concerns. These discussions often necessitate in-depth conversations to accurately understand the patients’ needs. Given HCP time constraints, they may view harm reduction as lower in urgency and priority relative to other concerns. While most respondents were in the reinforcement phase, it is important to note the ADKAR model is fluid, and therefore an HCP could move forward or backward. This movement can be noted in the postsurvey interviews where, for example, prescriber 6 was determined to be in the reinforcement stage since they had already discussed harm reduction with patients. However, prescriber 6 also noted a barrier of unfamiliarity with local laws, which could shift them to the ADKAR knowledge stage.

Respondents noted that education through didactic sessions could lead to better incorporation of harm reduction into patient care. While harm reduction has evidence supporting its effectiveness, the respondents noted willingness to discuss harm reduction when treatment fails or the patient refuses treatment or referrals. Respondents expressed mixed opinions on use of harm reduction tools among patients with SUDs as some prescribers viewed harm reduction as part of a treatment plan and others viewed a return to drug use as a failure of treatment. Furthermore, respondents expressed hesitancy surrounding certain harm reduction tools, such as fentanyl test strips or syringes, and perceived these supplies as intended for medical use rather than harm reduction. HCPs may feel uncomfortable offering these supplies for drug use, despite their use for reducing risk.

Most responses were received from VAMCs with large mental health substance use programs. Respondents at larger, urban facilities (Washington, DC, and Baltimore, Maryland) expressed more hesitancy around using harm reduction tools despite having more harm reduction resources available compared to smaller or rural sites. These results align with previous studies that found no difference in prescribers providing medications for OUD in rural and urban VAMCs, showing urban sites, despite more resources, are not more willing to provide harm reduction or other addiction services.¹⁹ This evidence might indicate that urban sites may not use available resources (eg, methadone clinics) or that rural sites can provide just as robust medications for OUD care as urban sites.

Follow-up interview analysis indicated that HCPs lack knowledge of certain harm reduction tools. One-on-one peer discussions, like academic detailing, can facilitate discussions around a prescriber’s role in harm reduction, address gaps in knowledge by sharing what is available at the facilities for harm reduction, and suggest conversation points to help prescribers start harm reduction discussions with patients unwilling to begin treatment. Additionally, academic detailing can connect prescribers to available resources in the community to provide pragmatic approaches and suggestions. A clear and consistent treatment process may reduce barriers by reassuring prescribers they have support and by providing consistent directions so that prescribers do not waste time.

Reinforcement is important for sustaining change. VAMCs could consider positive feedback and other evidence-based reinforcement strategies (eg, social recognition, continuing education) to communicate that these changes are noticed and appreciated.²⁰ Late adopters may also be influenced by seeing positive feedback and results for peers. Systematic changes can be the catalyst for and sustain individual change.

Shifting perceptions and adopting change may be challenging, especially for SUD, which can be highly stigmatized. Promotion of successful change should be multifaceted and include both system and individual approaches. VHA systemic changes that could contribute to positive change include provision of time and access to SUD treatment training, a clear and sustainable treatment process, and reinforcement by recognizing success. In addition, facility leadership could provide support through dedicated time and resources during the workday for SUD treatment and harm reduction training. Support could empower HCPs and convey leadership support for harm reduction. This dedicated time could be used for didactic lecture sessions or individual meetings with academic detailers who can tailor discussions to the prescriber’s practice.

Strengths and Limitations

This survey included prescribers from a range of mental health care practice settings (eg, inpatient, outpatient clinic, rural, urban) and varied years of experience. This variety resulted in diverse perspectives and knowledge bases. Postsurvey interviews allowed academic detailers to gain deeper insight into answers in the survey, which can guide future interventions. Postsurvey interviews and application of the ADKAR model provided additional viewpoints on harm reduction.

A limitation of this project is the absence of an assessment of respondents’ harm reduction knowledge accuracy. Although respondents reported confidence in discussing harm reduction with patients, the survey did not assess whether their knowledge was accurate. Additionally, the survey did not ask about the availability of syringes and test strips at the prescribers’ VAMC, which could explain discrepancies in responses between naloxone and other forms of harm reduction (drug test strips and syringes were not available to all HCPs in the VISN). This lack of availability may have skewed responses. West Virginia SSPs, for example, were closed following legislative changes, which may contribute to stigma.²¹

Not all respondents were asked to do a follow-up interview, which limited the perspectives included in this study. Each site had ≥ 1 follow-up interview to limit the academic detailer’s workload. The initial survey included the phrase clean syringe, which can be stigmatizing and insinuate that PWUD are not clean. The preferred term would have been sterile syringe.²²

Conclusions

This survey of mental health prescribers found that most respondents are comfortable treating patients with SUD and confident in educating patients on harm reduction. Additionally, most respondents were more willing to provide naloxone vs fentanyl test strips or sterile syringes. A lack of time and awareness was the most frequently cited barrier to harm reduction services. As the VHA continues to expand access to harm reduction programs, which have proven to increase treatment rates and reduce disease, it will be imperative for HCPs, including mental health prescribers, to recognize the benefit of these programs for veterans with SUD. Future interventions should be designed and evaluated in collaboration with all HCPs and patients. This project determined ways to promote change for prescribers, but it will be important for further research to continue those conversations and incorporate patient perspectives.

The Public Health and Welfare Act of 1988 prohibited the use of federal funds to “provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs.”¹ Although the Act included the caveat that the US Surgeon General may determine that “a demonstration needle exchange program would be effective in reducing drug abuse,” and thus federal funds could be used, the legislation prohibited federal, state, and local agencies from funding syringe services programs (SSPs). SSPs use various harm reduction tools to improve public safety and reduce the potential harmful consequences of risky behaviors, similar to how using a seat belt while driving reduces the risk of injury or death.² SSPs are rooted in evidence-based practices, and several studies, according to the Centers for Disease Control and Prevention, have found that people who use drugs (PWUDs) who use community-based SSPs are 5 times more likely to enter treatment than those who do not use these programs. Additionally, these programs have shown an estimated 50% reduction in HIV and hepatitis C infections.³

Amid a 2015 HIV outbreak in Indiana among individuals sharing needles for injection drug use, Congress passed an omnibus spending bill that partially lifted the federal funding restriction. Federal funds now may be used for operational costs that support SSPs but may not be used to purchase syringes themselves.⁴

Following the 2015 legislation, federal agencies began implementing SSPs. The Veterans Health Administration (VHA) established SSPs at 3 medical centers in 2017.⁵ Veterans who participated in the programs were able to access supplies (eg, syringes, fentanyl test strips, wound care kits, and condoms) through donations to US Department of Veterans Affairs (VA) medical centers (VAMCs). The success of these programs laid the foundation for the VHA to implement SSPs nationally. VHA SSPs provided access to naloxone (an opioid overdose reversal medication), fentanyl test strips, condoms, sterile syringe distribution, testing for blood-borne viruses, HIV pre-exposure prophylaxis, as well as educational materials and resources, and low-barrier access to drug treatment (eg, medications for opioid use disorder [OUD]).

In 2020, the Biden Administration outlined 7 drug policy priorities, which included enhancing evidence-based harm reduction efforts. ⁶ This policy also discussed mandates for federal agencies to remove barriers to federal funding for purchasing syringes and other harm reduction supplies. The VHA responded to the policy by publishing guidance that recommended VAMCs develop and/or ensure veterans have access to harm reduction services in the community, where state law is not legally more stringent.⁷

In 2025 the Trump administration Statement of Drug Policy Priorities encouraged local jurisdictions to increase the availability of drug test strips and naloxone.⁸ These significant policy shifts moved SSPs from being housed mostly in local public health departments and community-based organizations to also being available at health care facilities. ⁹ VAMCs have unique opportunities to provide universal health care that includes both prevention services and other medical management to PWUD.

One study assessed staff perceptions of PWUD at a VAMC in preparation for a training program about harm reduction. The results indicated an overall positive staff perception of PWUD, although only the Drug and Drug Problems Perceptions Questionnaire (DDPPQ) was administered, which assessed comfort of working with this population and not explicitly the use of harm reduction.¹⁰ Another study interviewed clinical pharmacists, primary care clinicians, social workers, and directors of addiction and mental health services to determine barriers and facilitators (ie, potential opportunities to promote change) to implementing harm reduction at the VHA. The study identified barriers to be a lack of knowledge, time, and comfort, while suggesting opportunities for improvement were engagement of champions, communication and educational strategies, and adaptation of existing infrastructure.¹¹

While these findings are insightful for the VHA to disseminate a harm reduction program, there remains a gap in assessing staff willingness to provide harm reduction services. Evidence on harm reduction services among veterans is limited and more research is needed to better understand the role of these services and acceptance among enrolled veterans and VHA staff. Specifically, more research is needed on health care practitioners’ (HCPs) perceptions of harm reduction use.

Mental health care practitioners frequently treat patients with substance use disorders (SUDs), making them an ideal initial cohort to assess willingness to provide harm reduction to this population. By analyzing mental HCPs’ perceptions, additional interventions could be identified, implemented, and evaluated to improve their willingness to provide harm reduction tools.

This project focused on mental health clinicians with prescribing privileges: physicians (allopathic and osteopathic physicians), nurse practitioners, physician assistants, and clinical pharmacist practitioners. Mental health prescribers were selected because they are uniquely positioned at the intersection of prevention and treatment in drug use. Furthermore, mental health prescribers at the VAMCs included in this study are usually the primary point of entry to SUD clinics. This mixed-methods study used an anonymous online survey and voluntary postsurvey discussions with mental health care prescribers to elaborate on their beliefs and attitudes, providing deeper insight into their responses regarding harm reduction.

Methods

This project was conducted by the Veterans Integrated Services Network (VISN) 5 academic detailing team. VISN 5 serves veterans from economically and demographically diverse areas in Maryland; Washington, DC; West Virginia; and portions of Virginia, Pennsylvania, Ohio, and Kentucky. VAMCs in Baltimore, Maryland, and Washington, DC, serve a largely urban population while the 4 West Virginia facilities in Martinsburg, Huntington, Beckley, and Clarksburg, serve a largely rural population. West Virginia has been the epicenter of the opioid crisis and consistently has the highest drug overdose deaths per capita in the United States.¹² Among cities, Baltimore, Maryland, has the highest number of drug overdose deaths per capita with 174.1 per 100,000 people.^12,13

At the time of this project, the 6 VISN 5 VAMCs had established overdose education and naloxone distribution (OEND) programs. Although OEND programs have existed since 2013, VISN 5 SSPs and harm reduction services that provided fentanyl test strips were only available at the Martinsburg, Beckley, and Huntington VAMCs. All 6 VAMCs had substance use treatment programs with a variety of inpatient and outpatient mental health services. The Washington, DC and Baltimore VAMCs had opioid treatment programs that provided methadone maintenance.

The VISN 5 academic detailing team consists of 7 clinical pharmacists. These academic detailers plan annual systematic interventions to provide medical knowledge translation services on health-related campaigns. Academic detailers are trained in change management and motivational interviewing. They uniquely facilitate conversations with HCPs on various topics or campaigns, aiming for quality improvement and behavioral change through positive relationships and sharing resources.¹⁴ Academic detailing conversations and relationships with HCPs involve assessing and understanding HCP behaviors, including barriers and readiness to change to align with the goal of improving patient outcomes. Academic detailing has improved practice behaviors around providing OEND in VHA.¹⁵

To prepare for a harm reduction campaign, the academic detailers sought to gain insight from target VISN 5 mental health prescribers. Figure 1 outlines the project timeline, which started with emails inviting mental health prescribers to complete an anonymous online survey. Academic detailers from each site emailed mental health prescribers who completed the survey to determine interest in expanding on survey findings. Mental health prescribers who completed the survey could participate in a postsurvey discussion.

Surveys

Between January 29, 2024, and February 22, 2024, the academic detailers emailed facility mental health prescribers (N = 156) a link to an anonymous 15-question survey. The email informed recipients of the survey’s purpose: to gain a better understanding of prescriber perceptions of veterans with SUD and harm reduction programs and their willingness to provide harm reduction tools, to better determine interventions that could be implemented.

The survey collected prescriber demographic data and their perceptions of PWUD and harm reduction tools and education. Survey questions were extrapolated from validated surveys (eg, DDPPQ) and survey-based implicit association test.^16,17 The survey used multiple choice and 5-point Likert scale questions. Mental health prescribers were asked about their role at the VHA, years in practice, medical center affiliation, type of SUDs treated (eg, opioid, stimulant, alcohol, cannabis, or other), and whether they had previously met with academic detailers about harm reduction.

Respondents read statements about patients with or without SUD and provided Likert scale responses describing their regard, level of comfort, and preferences. The survey included Likert scale questions about respondents’ comfort in providing harm reduction education and supplies. Respondents also noted whether they believed harm reduction reduced substance use, harm reduction tools encourage people with SUD to continue using drugs, and whether HCPs can impact clinical change.

Postsurvey interviews with predetermined questions were conducted in-person or via video conference with ≥ 1 prescriber at each VAMC by an academic detailer. The postsurvey discussion offered an opportunity for respondents to further elaborate and describe previous experiences and current beliefs that may affect their attitudes toward people with SUD and their views on harm reduction. Participants received no compensation for survey completion or interviews.

Analysis

The Washington VAMC Institutional Review Board reviewed and approved this project as quality improvement with potential publication. No inferential statistics were calculated. Survey participant demographics were reported using frequencies and proportions reported for categorical variables. Notes from follow-up interviews were analyzed using the Prosci Awareness, Desire, Knowledge, Ability, and Reinforcement (ADKAR) Model for Change Management.¹⁸ This framework is used by academic detailers to determine a prescriber’s stage of change, which helps select the appropriate resources to move the clinician along a change framework. Completed postsurvey interview sheets, including notes written by the academic detailer, were analyzed by the project lead (NJ) who reviewed each interview sheet and analysis with the academic detailer who led the discussion.

Results

Sixty-six respondents completed the online survey (42% response rate), and 7 mental health prescribers participated in a postsurvey discussion. Thirty-one participants (47%) were physicians and 17 (26%) were in practice for > 20 years. Response rates reflected the size of mental health staff at each VAMC at the time of the survey: 17 respondents (26%) worked at each of the Martinsburg and Baltimore VAMCs, with fewer at the other VAMCs (Table 1). Alcohol use disorder was the most commonly reported SUD treated (n = 62; 33%), followed by cannabis use disorder (n = 40; 21%), OUD (n = 38; 20%), and stimulant use disorder (n = 37; 20%).

Respondents felt comfortable and confident educating patients on ways to reduce harm related to substance use (91%; mean [SD], 4.24 [0.84]). Most prescribers surveyed (97%; mean [SD], 1.59 [0.68]) disagreed or strongly disagreed that harm reduction encourages patients with SUD to continue using drugs, and all prescribers surveyed disagreed that there is nothing they can do to encourage harm reduction. Survey results were mixed for personal comfort in working with people with SUD vs people without SUD (Figure 2). Respondents were most willing to provide naloxone (95%; mean [SD], 4.71 [0.78]), compared to fentanyl test strips (61%; mean [SD], 3.61 [1.41]) or syringes (39%; mean [SD], 3.18 [1.39]). Respondents were neutral or least willing to provide syringes (Figure 3).

Seven postsurvey interviews were completed between academic detailers and mental health clinicians across the 6 VAMCs. Respondents included 1 physician assistant, 1 nurse practitioner, 1 pharmacist, and 4 physicians. Notes were analyzed using the ADKAR Change Competency Model to organize clinician stages of change (Table 2).

Barriers identified by interviewees included lack of mobile services, lack of confidence and awareness of the availability of harm reduction at their respective medical center, lack of time to discuss harm reduction, negative sentiments toward providing SUD-related harm reduction, discomfort with harm reduction products, and lack of knowledge and time to learn about harm reduction services. Opportunities identified to drive change in practice included additional time allotted during patient appointments, educational discussions and presentations to increase knowledge of and comfort with harm reduction tools, a clear clinical patient care workflow and process for harm reduction services, and reinforcement strategies to recognize success.

Discussion

This project investigated mental health prescribers’ perceptions of harm reduction at VAMCs in West Virginia, Maryland, and Washington, DC. While previous studies have demonstrated the efficacy of harm reduction tools, there is a lack of research on HCPs willingness to use these resources. This study suggests that while most respondents feel confident in and see the value of offering harm reduction resources to patients, a disparity exists between which resources HCPs are more likely to use and factors that would further enhance their ability to integrate harm reduction into practice. The follow-up interviews provided additional insight into the survey results.

Most respondents met the awareness and desire stage and moved to the knowledge, ability, or reinforcement ADKAR stage. It would be reasonable to extrapolate that most of the respondents felt comfortable with and were very likely to offer certain harm reduction tools. In the ADKAR interview analysis, the most common factors needed to drive change included having more time during patient appointments, additional education, clear processes for harm reduction services, and reinforcement strategies to sustain change. Respondents noted that harm reduction discussions took extra time in their already limited appointments with patients, which may have limited time for discussions surrounding all other mental health concerns. These discussions often necessitate in-depth conversations to accurately understand the patients’ needs. Given HCP time constraints, they may view harm reduction as lower in urgency and priority relative to other concerns. While most respondents were in the reinforcement phase, it is important to note the ADKAR model is fluid, and therefore an HCP could move forward or backward. This movement can be noted in the postsurvey interviews where, for example, prescriber 6 was determined to be in the reinforcement stage since they had already discussed harm reduction with patients. However, prescriber 6 also noted a barrier of unfamiliarity with local laws, which could shift them to the ADKAR knowledge stage.

Respondents noted that education through didactic sessions could lead to better incorporation of harm reduction into patient care. While harm reduction has evidence supporting its effectiveness, the respondents noted willingness to discuss harm reduction when treatment fails or the patient refuses treatment or referrals. Respondents expressed mixed opinions on use of harm reduction tools among patients with SUDs as some prescribers viewed harm reduction as part of a treatment plan and others viewed a return to drug use as a failure of treatment. Furthermore, respondents expressed hesitancy surrounding certain harm reduction tools, such as fentanyl test strips or syringes, and perceived these supplies as intended for medical use rather than harm reduction. HCPs may feel uncomfortable offering these supplies for drug use, despite their use for reducing risk.

Most responses were received from VAMCs with large mental health substance use programs. Respondents at larger, urban facilities (Washington, DC, and Baltimore, Maryland) expressed more hesitancy around using harm reduction tools despite having more harm reduction resources available compared to smaller or rural sites. These results align with previous studies that found no difference in prescribers providing medications for OUD in rural and urban VAMCs, showing urban sites, despite more resources, are not more willing to provide harm reduction or other addiction services.¹⁹ This evidence might indicate that urban sites may not use available resources (eg, methadone clinics) or that rural sites can provide just as robust medications for OUD care as urban sites.

Follow-up interview analysis indicated that HCPs lack knowledge of certain harm reduction tools. One-on-one peer discussions, like academic detailing, can facilitate discussions around a prescriber’s role in harm reduction, address gaps in knowledge by sharing what is available at the facilities for harm reduction, and suggest conversation points to help prescribers start harm reduction discussions with patients unwilling to begin treatment. Additionally, academic detailing can connect prescribers to available resources in the community to provide pragmatic approaches and suggestions. A clear and consistent treatment process may reduce barriers by reassuring prescribers they have support and by providing consistent directions so that prescribers do not waste time.

Reinforcement is important for sustaining change. VAMCs could consider positive feedback and other evidence-based reinforcement strategies (eg, social recognition, continuing education) to communicate that these changes are noticed and appreciated.²⁰ Late adopters may also be influenced by seeing positive feedback and results for peers. Systematic changes can be the catalyst for and sustain individual change.

Shifting perceptions and adopting change may be challenging, especially for SUD, which can be highly stigmatized. Promotion of successful change should be multifaceted and include both system and individual approaches. VHA systemic changes that could contribute to positive change include provision of time and access to SUD treatment training, a clear and sustainable treatment process, and reinforcement by recognizing success. In addition, facility leadership could provide support through dedicated time and resources during the workday for SUD treatment and harm reduction training. Support could empower HCPs and convey leadership support for harm reduction. This dedicated time could be used for didactic lecture sessions or individual meetings with academic detailers who can tailor discussions to the prescriber’s practice.

Strengths and Limitations

This survey included prescribers from a range of mental health care practice settings (eg, inpatient, outpatient clinic, rural, urban) and varied years of experience. This variety resulted in diverse perspectives and knowledge bases. Postsurvey interviews allowed academic detailers to gain deeper insight into answers in the survey, which can guide future interventions. Postsurvey interviews and application of the ADKAR model provided additional viewpoints on harm reduction.

A limitation of this project is the absence of an assessment of respondents’ harm reduction knowledge accuracy. Although respondents reported confidence in discussing harm reduction with patients, the survey did not assess whether their knowledge was accurate. Additionally, the survey did not ask about the availability of syringes and test strips at the prescribers’ VAMC, which could explain discrepancies in responses between naloxone and other forms of harm reduction (drug test strips and syringes were not available to all HCPs in the VISN). This lack of availability may have skewed responses. West Virginia SSPs, for example, were closed following legislative changes, which may contribute to stigma.²¹

Not all respondents were asked to do a follow-up interview, which limited the perspectives included in this study. Each site had ≥ 1 follow-up interview to limit the academic detailer’s workload. The initial survey included the phrase clean syringe, which can be stigmatizing and insinuate that PWUD are not clean. The preferred term would have been sterile syringe.²²

Conclusions

This survey of mental health prescribers found that most respondents are comfortable treating patients with SUD and confident in educating patients on harm reduction. Additionally, most respondents were more willing to provide naloxone vs fentanyl test strips or sterile syringes. A lack of time and awareness was the most frequently cited barrier to harm reduction services. As the VHA continues to expand access to harm reduction programs, which have proven to increase treatment rates and reduce disease, it will be imperative for HCPs, including mental health prescribers, to recognize the benefit of these programs for veterans with SUD. Future interventions should be designed and evaluated in collaboration with all HCPs and patients. This project determined ways to promote change for prescribers, but it will be important for further research to continue those conversations and incorporate patient perspectives.

Growing recognition of the limitations of long-term opioid therapy for chronic noncancer pain has highlighted the importance of nonpharmacologic approaches to pain treatment.^1,2 These treatments are varied and may include psychological and behavioral therapies (eg, cognitive behavioral therapy for chronic pain), exercise and movement therapies (eg, yoga), and manual therapies (eg, chiropractic). Body surface cold therapy, while predominantly used to reduce postoperative pain and inflammation,^3,4 pain subsequent to acute musculoskeletal injury,⁵ and pain related to muscle soreness,⁶ is a nonpharmacologic treatment that has shown pain-reducing benefits for chronic low back pain and knee osteoarthritis, as has its counterpart, superficial heat therapy.^7-9 Heat therapy has also been shown to improve strength, flexibility, and activities of daily living in patients with chronic low back pain.^10,11 Cold and heat therapies are commonly used complementarily. Cold therapies aim to reduce blood flow and inflammation and are often used immediately following trauma to an affected area, whereas heat therapies increase blood flow and metabolic activity and are commonly used to promote healing.⁵

Heat and cold therapies (also known as thermal therapies) benefit resource-limited health care systems, as most devices require a single expenditure and can be self-administered by patients at home as part of their pain self-management plan. In addition, these pain self-management tools may attenuate the need for more expensive specialty pain care and ongoing analgesic pharmacotherapy. Despite their potential, few studies have characterized the benefits of thermal therapies for patients with heterogeneous chronic pain syndromes.

The purpose of this retrospective cohort study was to examine the potential clinical and health system benefits of patient-administered thermal therapy. Our primary hypothesis was that patients with chronic musculoskeletal pain who received a thermal therapy self-management device would have fewer days of opioid prescriptions compared with a sample of matched control patients. Secondarily, we hypothesized that patients who received a thermal therapy device would have lower utilization of specialty pain care, fewer potentially hazardous opioid prescriptions (eg, high-dose opioid therapy and concurrent opioid and benzodiazepine prescriptions), fewer prescriptions for nonopioid analgesic medications, and decreased pain intensity when compared with matched controls.

Methods

This retrospective cohort study compared pain pharmacotherapy, pain treatment utilization, and pain intensity outcomes between patients who received a thermal therapy device and matched patients who did not. The study was approved by the US Department of Veterans Affairs (VA) Portland Health Care System Institutional Review Board and was granted a waiver of informed consent to access patient electronic health records (EHRs).

Pain Care

The VA uses ThermaZone thermal therapy devices (Innovative Medical Equipment) for chronic pain treatment. The device uses thermoelectric technology to provide point-of-contact cooling and heating therapy through site-specific pads (eg, ankle, knee, hip, back, elbow, shoulder). Patients place pads on sites where they experience pain, and temperature regulated water circulates through the device and to the pad, providing consistent, localized thermal therapy. The pads range in temperature from 1 °C to 52 °C, and temperatures are self-monitored and controlled by the patient.

Standard pain care in this study followed the VA stepped model of pain care, which builds on a foundation of patient education for pain self-management approaches (eg, exercise, mindfulness, relaxation, social support).¹² According to the VA stepped model of pain care, all patients with chronic pain should engage in these foundational self-management approaches. However, some patients require more intensive care. The VA stepped-up treatment engages primary and specialty care services—such as physical therapy, pharmacy, complementary and integrative health approaches, mental health, and substance use services—and, when indicated, may escalate treatment to interdisciplinary pain teams or tertiary pain centers. In this retrospective cohort study, treatment patients received a thermal therapy device and standard of care, whereas control patients received standard care only.

Sample Selection

Eligible patients were aged ≥ 18 years, had a musculoskeletal pain diagnosis documented in the EHR in the year prior to thermal therapy device receipt (or during the same period for a treatment patient’s matched control), and were enrolled in VA health care during the study period. Patients who died during the study period were excluded. Treatment patients received a thermal therapy device from the VA between January 1, 2017, and December 31, 2018, when complete data on thermal therapy devices were available. For control patients, the VA Corporate Data Warehouse (CDW) was used to identify VA patients with characteristics similar to those of treated patients.

We modeled the probability that a patient would receive a thermal therapy device using logistic regression. Predictor variables were measured in the year prior to device receipt and included variables associated with pain treatment utilization and analgesic pharmacotherapy receipt, as recommended by Brookhart et al.¹³ These included age, sex, race, ethnicity, VA service-connected disability status, comorbidities, receipt of medications for opioid use disorder, pain diagnoses, mental health diagnoses, and substance use disorder diagnoses.^14-19

The resulting propensity scores (eg, predicted probabilities) were used to match treatment patients 1:1 with control patients using a nearest-neighbor matching algorithm.²⁰ This procedure matches a control patient with the closest propensity score to that of the corresponding treatment patient. An exact match on VA facility was required (eg, treatment patients and matched controls received care at the same VA facility). Standardized differences were used to assess covariate balance between the matched groups, and kernel density plots of propensity scores tested for sufficient overlap.²¹ Control patients were selected from a pool of 1,150,149 patients.

Study Variables

The index date was the date the thermal therapy device was released to treatment patients or the same date for the matched controls. Data were extracted from the CDW over a 24-month period: 12 months prior to the index date through 12 months afterwards. Collecting data in the 12 months prior to treatment initiation allowed us to adjust for covariates and provided greater precision, as recommended for observational study designs.²²

Treatment conditions were defined dichotomously as receipt vs nonreceipt of a thermal therapy device. The primary outcome was the number of days of opioid use in the 12 months following the index date. Additional outcomes included days of high-dose opioid therapy (≥ 50 mg morphine equivalent [MME] daily), concurrent opioid and benzodiazepine prescriptions, and nonopioid analgesic pharmacotherapy (eg, nonsteroidal anti-inflammatory drugs, acetaminophen, muscle relaxants). All prescription data were based on medication fills obtained from VA pharmacy records. Additional outcomes included the number of visits to physical therapy, occupational therapy, physical medicine and rehabilitation, and interdisciplinary pain clinics, including interventional pain medicine.

Pain intensity ratings were collected as part of routine VA care using a numeric scale from 0 (no pain) to 10 (worst possible pain). Pain intensity trajectories were computed using all available EHR-derived pain intensity score data for each patient in the 12 months prior to and following the index date.

Covariates were extracted from the EHR and evaluated in the year prior to the index date, unless otherwise noted. They included age at the index date; self-reported sex, and race and ethnicity; service-connected disability status (disability awarded as a result of military service-related trauma or injury); Charlson Comorbidity Index; and diagnoses of opioid use disorder, alcohol use disorder, other substance use disorder, mood disorder, posttraumatic stress disorder, other anxiety disorder, psychotic disorder, neuropathic pain, and headache pain.²³ All diagnoses were coded as yes if identified in the EHR as a focus of treatment during any clinical encounter in the year prior to the index date or no if not identified as a focus of treatment.

The number of days patients had been living with pain was calculated and defined as the number of days from the first pain diagnosis available in a patient’s EHR to the index date. Finally, the number of pain-related surgeries (eg, surgeries with ≥ 1 pain diagnoses associated with the clinical encounter) and average pain intensity were computed for the pre- and postindex date evaluation periods and included as model covariates.

Statistical Analyses

For the 4 pharmacotherapy and 4 nonpharmacologic treatment usage outcomes, we tested the fit of linear models and several models with count distributions using the Bayesian information criterion.²⁴ Count distributions included Poisson, zero-inflated Poisson, negative binomial, and zero-inflated negative binomial. With 1 exception (days of high-dose opioid use), a negative binomial distribution best fit the data. For days of high-dose opioid use, a Gaussian distribution best fit the data.

Eight separate mixed-effects regression analyses compared changes in each outcome from the 12-month preindex period through the 12-month postindex period between treatment and control patients by testing the Time × Treatment interaction. This approach statistically accounts for observed pretreatment differences in outcome variables. Statistics for the main effects of time and treatment are also presented. To reduce bias, models controlled for covariates specified previously.

For pain intensity, we used random-effects growth modeling to quantify both fixed and random effects of pain intensity at the index date (eg, the model intercept), which estimates pain at the time of treatment initiation, and change in pain during the 12 months following the index date (eg, the model slope), which characterizes the trajectory of pain intensity ratings.²⁵ The model included piecewise components of pain score trajectories in the 12 months prior to the index date and in the 12 months following the index date. Several types of change for the 12-month postindex observation period were explored—including quadratic and cubic curvilinear change. A linear model for change in pain over time provided the best fit based on the Bayesian information criterion and parsimony of model parameters.²⁶ We report estimates of change in pain over time in monthly intervals for ease of interpretation. However, models used all individual pain scores rather than computing monthly averages when > 1 pain score was available within a month, as recommended in previous research.²⁷ This approach makes optimal use of all available data. Both random effects (intercept and slope) were regressed onto the set of covariates described previously.

This study used data available in the EHR over the 24-month observation period. We characterize the density (eg, frequency) of all outcome variables by treatment condition in the Appendix. Because the hypotheses were directional, the authors used a 2-sided α = 0.10 and applied a Bonferroni correction for the 9 statistical tests performed, resulting in an adjusted α of 0.01. Treatment utilization and pharmacotherapy outcome analyses were performed in Stata, version 16.1. Random-effects growth modeling of pain score trajectories was performed using Mplus, version 8.8.

Results

There were 2182 patients in the treatment group and 2182 matched controls. The mean (SD) age was 54 (15) years; 81% were male, and about two-thirds (68%) identified as White and non-Hispanic. Mental health comorbidities were common, with > 40% of the sample having diagnoses of a mood disorder and/or posttraumatic stress disorder. Nearly all patients (90%) had VA service-connected disability ratings. Among patients with chronic musculoskeletal pain, 8% had comorbid neuropathic pain and 14% had headache. The mean (SD) duration of chronic pain across both patient groups was 3416 (2016) days, or about 9.4 years (Table 1).

Pharmacotherapy

High-dose opioid use (> 50 MME daily dose), days of opioid use, and concurrent opioid and benzodiazepine use decreased for all patients from the pre- to posttreatment period (Table 2). However, high-dose opioid use (Time × Treatment interaction, 3.24; 99% CI, 0.34 to 6.14) (Figure 1A) and concurrent opioid and benzodiazepine use (Time × Treatment interaction, 0.76; 99% CI, 0.67 to 0.86) (Figure 1B) had a larger decrease for the treatment vs matched control group. Treatment and matched control patients had comparable reductions in days of opioid use (Time × Treatment interaction, 0.98; 99% CI, 0.91 to 1.05) (Figure 1C). Neither group showed changes in nonopioid analgesic pharmacotherapy over time (main effect of time, incidence rate ratio [IRR], 1.03; 99% CI, 0.99 to 1.07; Time × Treatment interaction, 0.95; 99% CI, 0.90 to 1.01) (Figure 1D).

Nonpharmacologic Pain Treatment

The number of physical therapy and pain clinic visits declined for treatment patients and increased slightly for matched control patients (Figure 2A and 2B). For occupational therapy visits, neither group showed changes over time (main effect of time IRR, 1.03; 99% CI, 0.83 to 1.22; Time × Treatment interaction, 1.20; 99% CI, 0.93 to 1.46) (Figure 2C). For physical medicine and rehabilitation visits, both groups decreased use over time (main effect of time IRR, 0.78; 99% CI, 0.66 to 0.90), but this decrease did not differ between treatment and control patients (Time × Treatment interaction, 1.16; 99% CI, 0.94 to 1.37) (Figure 2D).

Pain Intensity

Pain intensity decreased for both groups by an estimated 0.02 points per month (99% CI, -0.04 to -0.01; P < .01), or 0.24 points over the 12-month postindex follow-up period (Figure 3). There were no statistically significant differences between treatment and control patients in pain intensity changes over the follow-up period (B = -0.02; 99% CI, -0.06 to 0.02; P = .15).

Discussion

Patients with musculoskeletal pain who received a thermal therapy device showed a larger decline in use of some specialty pain treatments, including physical therapy and specialty pain clinic services, when compared with matched control patients. One possible explanation is that patients who used the device may have had their pain adequately managed and thus required less specialty pain care. However, the absence of clinically significant changes in pain intensity over time suggests that pain intensity alone did not account for the observed changes in pain treatment use. We were unable to measure constructs of pain interference or functioning, which may be better predictors of functional restoration, as these data are not routinely collected within the VA and documented in the EHR. Future studies could clarify these findings by including measures of pain interference and functioning.

Although the overall declines in physical therapy and specialty pain clinic use associated with thermal therapy were modest (< 1 visit per patient), the impact of these reductions can be profound. In resource-limited health care settings, even small reductions in high-cost care utilization could be of great value in that health systems could offset costs associated with treating chronic pain without compromising quality of care or key clinical outcomes, such as pain intensity. This study, however, did not include a cost analysis. Future studies should incorporate formal cost analyses to quantify cost offsets that may result from decreased specialty pain treatment use.

Patients who received thermal therapy devices did not show clinically meaningful reductions in pain intensity over time, defined as reductions in pain intensity of 1.7 to 2.0 on a 0 to 10 scale.^28,29 This finding is consistent with prior research that demonstrates relatively stable pain intensity self-ratings longitudinally by patients with chronic pain diagnoses, when assessed in the context of usual clinical care.³⁰ This finding, however, is inconsistent with prior literature that demonstrates pain-reducing benefits of thermal therapy for low back pain and knee osteoarthritis.^7-9

In this study, pain intensity ratings were derived from the EHR during routine outpatient clinical encounters and not at the time thermal therapy was self-administered, as has been done in prior clinical trials.^7-9 Pain location was not specified at the time of pain ratings, and it is possible that patients may have been endorsing pain in areas of the body that had not been treated by thermal therapy. Patient-level variability in pain intensity ratings (eg, within-patient range over time) was not examined, although prior research indicates substantial variability.³⁰ While average pain intensity ratings in the current study did not change, an examination of patient variability warrants further study, as a narrowing of pain intensity ratings can be perceived, by patients, as demonstrable improvement and has been associated with improved physical and psychological outcomes.³¹ Furthermore, pain intensity does not characterize physical or emotional functioning that can be captured with more comprehensive validated measures, some of which are recommended outcomes in pain clinical trials.³²

Our findings point to reductions in all forms of opioid use across both treatment and control patients. Data from the VA and in the US more generally point to downward trends in opioid prescribing during the study period.³³ This decline is likely due to increased use of risk mitigation approaches, such as routine urine drug screens and review of prescription drug monitoring databases.³⁴ These state-level databases track prescribing of controlled substances, including opioids and benzodiazepines, within a state. Implementation of these practices has been associated with declines in higher risk opioid prescribing.³⁴ Findings from this study further point to associations of reduced higher risk opioid use among patients who received thermal therapy devices. In the full sample of patients, reductions in days of opioid use, high-dose opioid use, and co-use of opioids and benzodiazepines were observed across all patients, with greater reductions observed in high-dose opioid use and concurrent opioid and benzodiazepine use among patients who received a thermal therapy device. Experimental studies indicate that the endogenous opioid system is implicated in pain relief and activated by thermal therapies. ³⁵ Differential reductions in higher-risk opioid use among patients who received thermal therapy devices in our study may be associated with endogenous opioid activation, though this was not specifically measured. It is also unclear whether thermal therapy was provided by clinicians in the context of opioid tapering or other risk mitigation efforts, or patients reduced higher risk opioid use of their own volition. Prior research has identified both patient- and clinician-initiated opioid tapering and discontinuation.³⁶ While a thorough explication of opioid dose reduction was beyond the scope of this study, future qualitative work could help explain potential benefits of thermal therapy in the context of analgesic pharmacotherapy use, including opioid medications.

Limitations

The extent to which patients used the thermal therapy device could not be measured; therefore, device receipt was used as a proxy for use. However, it was not possible to determine whether the frequency and duration of device use was associated with study outcomes. Treatment and control groups demonstrated some differences in outcome variables at the index date. Potential known biases were addressed using propensity score matching procedures and statistical procedures that controlled for patient demographic and clinical characteristics, as well as pretreatment values of all outcome variables. Nevertheless, as an observational study, this analysis cannot account for all known and unknown confounders, and a randomized controlled trial is needed to make claims of causality. The study population consisted of US veterans and included a low proportion of women. As a result, the findings may not be generalizable to other patient populations. Finally, prescription dispensing data, used as a proxy for pharmacotherapy use, do not necessarily reflect actual medication use.

Conclusions

This study is among the first to examine associations between thermal therapy and specialty pain treatment and analgesic pharmacotherapy use among US veterans. Although the retrospective cohort study design does not allow causal inferences regarding the efficacy of thermal therapy for veterans with chronic musculoskeletal pain, confidence in the findings is strengthened by methodological and statistical control of known confounders. Future trials employing experimental designs are needed to further clarify the clinical and health systems benefits of thermal therapy for musculoskeletal pain syndromes.

Growing recognition of the limitations of long-term opioid therapy for chronic noncancer pain has highlighted the importance of nonpharmacologic approaches to pain treatment.^1,2 These treatments are varied and may include psychological and behavioral therapies (eg, cognitive behavioral therapy for chronic pain), exercise and movement therapies (eg, yoga), and manual therapies (eg, chiropractic). Body surface cold therapy, while predominantly used to reduce postoperative pain and inflammation,^3,4 pain subsequent to acute musculoskeletal injury,⁵ and pain related to muscle soreness,⁶ is a nonpharmacologic treatment that has shown pain-reducing benefits for chronic low back pain and knee osteoarthritis, as has its counterpart, superficial heat therapy.^7-9 Heat therapy has also been shown to improve strength, flexibility, and activities of daily living in patients with chronic low back pain.^10,11 Cold and heat therapies are commonly used complementarily. Cold therapies aim to reduce blood flow and inflammation and are often used immediately following trauma to an affected area, whereas heat therapies increase blood flow and metabolic activity and are commonly used to promote healing.⁵

Heat and cold therapies (also known as thermal therapies) benefit resource-limited health care systems, as most devices require a single expenditure and can be self-administered by patients at home as part of their pain self-management plan. In addition, these pain self-management tools may attenuate the need for more expensive specialty pain care and ongoing analgesic pharmacotherapy. Despite their potential, few studies have characterized the benefits of thermal therapies for patients with heterogeneous chronic pain syndromes.

The purpose of this retrospective cohort study was to examine the potential clinical and health system benefits of patient-administered thermal therapy. Our primary hypothesis was that patients with chronic musculoskeletal pain who received a thermal therapy self-management device would have fewer days of opioid prescriptions compared with a sample of matched control patients. Secondarily, we hypothesized that patients who received a thermal therapy device would have lower utilization of specialty pain care, fewer potentially hazardous opioid prescriptions (eg, high-dose opioid therapy and concurrent opioid and benzodiazepine prescriptions), fewer prescriptions for nonopioid analgesic medications, and decreased pain intensity when compared with matched controls.

Methods

This retrospective cohort study compared pain pharmacotherapy, pain treatment utilization, and pain intensity outcomes between patients who received a thermal therapy device and matched patients who did not. The study was approved by the US Department of Veterans Affairs (VA) Portland Health Care System Institutional Review Board and was granted a waiver of informed consent to access patient electronic health records (EHRs).

Pain Care

The VA uses ThermaZone thermal therapy devices (Innovative Medical Equipment) for chronic pain treatment. The device uses thermoelectric technology to provide point-of-contact cooling and heating therapy through site-specific pads (eg, ankle, knee, hip, back, elbow, shoulder). Patients place pads on sites where they experience pain, and temperature regulated water circulates through the device and to the pad, providing consistent, localized thermal therapy. The pads range in temperature from 1 °C to 52 °C, and temperatures are self-monitored and controlled by the patient.

Standard pain care in this study followed the VA stepped model of pain care, which builds on a foundation of patient education for pain self-management approaches (eg, exercise, mindfulness, relaxation, social support).¹² According to the VA stepped model of pain care, all patients with chronic pain should engage in these foundational self-management approaches. However, some patients require more intensive care. The VA stepped-up treatment engages primary and specialty care services—such as physical therapy, pharmacy, complementary and integrative health approaches, mental health, and substance use services—and, when indicated, may escalate treatment to interdisciplinary pain teams or tertiary pain centers. In this retrospective cohort study, treatment patients received a thermal therapy device and standard of care, whereas control patients received standard care only.

Sample Selection

Eligible patients were aged ≥ 18 years, had a musculoskeletal pain diagnosis documented in the EHR in the year prior to thermal therapy device receipt (or during the same period for a treatment patient’s matched control), and were enrolled in VA health care during the study period. Patients who died during the study period were excluded. Treatment patients received a thermal therapy device from the VA between January 1, 2017, and December 31, 2018, when complete data on thermal therapy devices were available. For control patients, the VA Corporate Data Warehouse (CDW) was used to identify VA patients with characteristics similar to those of treated patients.

We modeled the probability that a patient would receive a thermal therapy device using logistic regression. Predictor variables were measured in the year prior to device receipt and included variables associated with pain treatment utilization and analgesic pharmacotherapy receipt, as recommended by Brookhart et al.¹³ These included age, sex, race, ethnicity, VA service-connected disability status, comorbidities, receipt of medications for opioid use disorder, pain diagnoses, mental health diagnoses, and substance use disorder diagnoses.^14-19

The resulting propensity scores (eg, predicted probabilities) were used to match treatment patients 1:1 with control patients using a nearest-neighbor matching algorithm.²⁰ This procedure matches a control patient with the closest propensity score to that of the corresponding treatment patient. An exact match on VA facility was required (eg, treatment patients and matched controls received care at the same VA facility). Standardized differences were used to assess covariate balance between the matched groups, and kernel density plots of propensity scores tested for sufficient overlap.²¹ Control patients were selected from a pool of 1,150,149 patients.

Study Variables

The index date was the date the thermal therapy device was released to treatment patients or the same date for the matched controls. Data were extracted from the CDW over a 24-month period: 12 months prior to the index date through 12 months afterwards. Collecting data in the 12 months prior to treatment initiation allowed us to adjust for covariates and provided greater precision, as recommended for observational study designs.²²

Treatment conditions were defined dichotomously as receipt vs nonreceipt of a thermal therapy device. The primary outcome was the number of days of opioid use in the 12 months following the index date. Additional outcomes included days of high-dose opioid therapy (≥ 50 mg morphine equivalent [MME] daily), concurrent opioid and benzodiazepine prescriptions, and nonopioid analgesic pharmacotherapy (eg, nonsteroidal anti-inflammatory drugs, acetaminophen, muscle relaxants). All prescription data were based on medication fills obtained from VA pharmacy records. Additional outcomes included the number of visits to physical therapy, occupational therapy, physical medicine and rehabilitation, and interdisciplinary pain clinics, including interventional pain medicine.

Pain intensity ratings were collected as part of routine VA care using a numeric scale from 0 (no pain) to 10 (worst possible pain). Pain intensity trajectories were computed using all available EHR-derived pain intensity score data for each patient in the 12 months prior to and following the index date.

Covariates were extracted from the EHR and evaluated in the year prior to the index date, unless otherwise noted. They included age at the index date; self-reported sex, and race and ethnicity; service-connected disability status (disability awarded as a result of military service-related trauma or injury); Charlson Comorbidity Index; and diagnoses of opioid use disorder, alcohol use disorder, other substance use disorder, mood disorder, posttraumatic stress disorder, other anxiety disorder, psychotic disorder, neuropathic pain, and headache pain.²³ All diagnoses were coded as yes if identified in the EHR as a focus of treatment during any clinical encounter in the year prior to the index date or no if not identified as a focus of treatment.

The number of days patients had been living with pain was calculated and defined as the number of days from the first pain diagnosis available in a patient’s EHR to the index date. Finally, the number of pain-related surgeries (eg, surgeries with ≥ 1 pain diagnoses associated with the clinical encounter) and average pain intensity were computed for the pre- and postindex date evaluation periods and included as model covariates.

Statistical Analyses

For the 4 pharmacotherapy and 4 nonpharmacologic treatment usage outcomes, we tested the fit of linear models and several models with count distributions using the Bayesian information criterion.²⁴ Count distributions included Poisson, zero-inflated Poisson, negative binomial, and zero-inflated negative binomial. With 1 exception (days of high-dose opioid use), a negative binomial distribution best fit the data. For days of high-dose opioid use, a Gaussian distribution best fit the data.

Eight separate mixed-effects regression analyses compared changes in each outcome from the 12-month preindex period through the 12-month postindex period between treatment and control patients by testing the Time × Treatment interaction. This approach statistically accounts for observed pretreatment differences in outcome variables. Statistics for the main effects of time and treatment are also presented. To reduce bias, models controlled for covariates specified previously.

For pain intensity, we used random-effects growth modeling to quantify both fixed and random effects of pain intensity at the index date (eg, the model intercept), which estimates pain at the time of treatment initiation, and change in pain during the 12 months following the index date (eg, the model slope), which characterizes the trajectory of pain intensity ratings.²⁵ The model included piecewise components of pain score trajectories in the 12 months prior to the index date and in the 12 months following the index date. Several types of change for the 12-month postindex observation period were explored—including quadratic and cubic curvilinear change. A linear model for change in pain over time provided the best fit based on the Bayesian information criterion and parsimony of model parameters.²⁶ We report estimates of change in pain over time in monthly intervals for ease of interpretation. However, models used all individual pain scores rather than computing monthly averages when > 1 pain score was available within a month, as recommended in previous research.²⁷ This approach makes optimal use of all available data. Both random effects (intercept and slope) were regressed onto the set of covariates described previously.

This study used data available in the EHR over the 24-month observation period. We characterize the density (eg, frequency) of all outcome variables by treatment condition in the Appendix. Because the hypotheses were directional, the authors used a 2-sided α = 0.10 and applied a Bonferroni correction for the 9 statistical tests performed, resulting in an adjusted α of 0.01. Treatment utilization and pharmacotherapy outcome analyses were performed in Stata, version 16.1. Random-effects growth modeling of pain score trajectories was performed using Mplus, version 8.8.

Results

There were 2182 patients in the treatment group and 2182 matched controls. The mean (SD) age was 54 (15) years; 81% were male, and about two-thirds (68%) identified as White and non-Hispanic. Mental health comorbidities were common, with > 40% of the sample having diagnoses of a mood disorder and/or posttraumatic stress disorder. Nearly all patients (90%) had VA service-connected disability ratings. Among patients with chronic musculoskeletal pain, 8% had comorbid neuropathic pain and 14% had headache. The mean (SD) duration of chronic pain across both patient groups was 3416 (2016) days, or about 9.4 years (Table 1).

Pharmacotherapy

High-dose opioid use (> 50 MME daily dose), days of opioid use, and concurrent opioid and benzodiazepine use decreased for all patients from the pre- to posttreatment period (Table 2). However, high-dose opioid use (Time × Treatment interaction, 3.24; 99% CI, 0.34 to 6.14) (Figure 1A) and concurrent opioid and benzodiazepine use (Time × Treatment interaction, 0.76; 99% CI, 0.67 to 0.86) (Figure 1B) had a larger decrease for the treatment vs matched control group. Treatment and matched control patients had comparable reductions in days of opioid use (Time × Treatment interaction, 0.98; 99% CI, 0.91 to 1.05) (Figure 1C). Neither group showed changes in nonopioid analgesic pharmacotherapy over time (main effect of time, incidence rate ratio [IRR], 1.03; 99% CI, 0.99 to 1.07; Time × Treatment interaction, 0.95; 99% CI, 0.90 to 1.01) (Figure 1D).

Nonpharmacologic Pain Treatment

The number of physical therapy and pain clinic visits declined for treatment patients and increased slightly for matched control patients (Figure 2A and 2B). For occupational therapy visits, neither group showed changes over time (main effect of time IRR, 1.03; 99% CI, 0.83 to 1.22; Time × Treatment interaction, 1.20; 99% CI, 0.93 to 1.46) (Figure 2C). For physical medicine and rehabilitation visits, both groups decreased use over time (main effect of time IRR, 0.78; 99% CI, 0.66 to 0.90), but this decrease did not differ between treatment and control patients (Time × Treatment interaction, 1.16; 99% CI, 0.94 to 1.37) (Figure 2D).

Pain Intensity

Pain intensity decreased for both groups by an estimated 0.02 points per month (99% CI, -0.04 to -0.01; P < .01), or 0.24 points over the 12-month postindex follow-up period (Figure 3). There were no statistically significant differences between treatment and control patients in pain intensity changes over the follow-up period (B = -0.02; 99% CI, -0.06 to 0.02; P = .15).

Discussion

Patients with musculoskeletal pain who received a thermal therapy device showed a larger decline in use of some specialty pain treatments, including physical therapy and specialty pain clinic services, when compared with matched control patients. One possible explanation is that patients who used the device may have had their pain adequately managed and thus required less specialty pain care. However, the absence of clinically significant changes in pain intensity over time suggests that pain intensity alone did not account for the observed changes in pain treatment use. We were unable to measure constructs of pain interference or functioning, which may be better predictors of functional restoration, as these data are not routinely collected within the VA and documented in the EHR. Future studies could clarify these findings by including measures of pain interference and functioning.

Although the overall declines in physical therapy and specialty pain clinic use associated with thermal therapy were modest (< 1 visit per patient), the impact of these reductions can be profound. In resource-limited health care settings, even small reductions in high-cost care utilization could be of great value in that health systems could offset costs associated with treating chronic pain without compromising quality of care or key clinical outcomes, such as pain intensity. This study, however, did not include a cost analysis. Future studies should incorporate formal cost analyses to quantify cost offsets that may result from decreased specialty pain treatment use.

Patients who received thermal therapy devices did not show clinically meaningful reductions in pain intensity over time, defined as reductions in pain intensity of 1.7 to 2.0 on a 0 to 10 scale.^28,29 This finding is consistent with prior research that demonstrates relatively stable pain intensity self-ratings longitudinally by patients with chronic pain diagnoses, when assessed in the context of usual clinical care.³⁰ This finding, however, is inconsistent with prior literature that demonstrates pain-reducing benefits of thermal therapy for low back pain and knee osteoarthritis.^7-9

In this study, pain intensity ratings were derived from the EHR during routine outpatient clinical encounters and not at the time thermal therapy was self-administered, as has been done in prior clinical trials.^7-9 Pain location was not specified at the time of pain ratings, and it is possible that patients may have been endorsing pain in areas of the body that had not been treated by thermal therapy. Patient-level variability in pain intensity ratings (eg, within-patient range over time) was not examined, although prior research indicates substantial variability.³⁰ While average pain intensity ratings in the current study did not change, an examination of patient variability warrants further study, as a narrowing of pain intensity ratings can be perceived, by patients, as demonstrable improvement and has been associated with improved physical and psychological outcomes.³¹ Furthermore, pain intensity does not characterize physical or emotional functioning that can be captured with more comprehensive validated measures, some of which are recommended outcomes in pain clinical trials.³²

Our findings point to reductions in all forms of opioid use across both treatment and control patients. Data from the VA and in the US more generally point to downward trends in opioid prescribing during the study period.³³ This decline is likely due to increased use of risk mitigation approaches, such as routine urine drug screens and review of prescription drug monitoring databases.³⁴ These state-level databases track prescribing of controlled substances, including opioids and benzodiazepines, within a state. Implementation of these practices has been associated with declines in higher risk opioid prescribing.³⁴ Findings from this study further point to associations of reduced higher risk opioid use among patients who received thermal therapy devices. In the full sample of patients, reductions in days of opioid use, high-dose opioid use, and co-use of opioids and benzodiazepines were observed across all patients, with greater reductions observed in high-dose opioid use and concurrent opioid and benzodiazepine use among patients who received a thermal therapy device. Experimental studies indicate that the endogenous opioid system is implicated in pain relief and activated by thermal therapies. ³⁵ Differential reductions in higher-risk opioid use among patients who received thermal therapy devices in our study may be associated with endogenous opioid activation, though this was not specifically measured. It is also unclear whether thermal therapy was provided by clinicians in the context of opioid tapering or other risk mitigation efforts, or patients reduced higher risk opioid use of their own volition. Prior research has identified both patient- and clinician-initiated opioid tapering and discontinuation.³⁶ While a thorough explication of opioid dose reduction was beyond the scope of this study, future qualitative work could help explain potential benefits of thermal therapy in the context of analgesic pharmacotherapy use, including opioid medications.

Limitations

The extent to which patients used the thermal therapy device could not be measured; therefore, device receipt was used as a proxy for use. However, it was not possible to determine whether the frequency and duration of device use was associated with study outcomes. Treatment and control groups demonstrated some differences in outcome variables at the index date. Potential known biases were addressed using propensity score matching procedures and statistical procedures that controlled for patient demographic and clinical characteristics, as well as pretreatment values of all outcome variables. Nevertheless, as an observational study, this analysis cannot account for all known and unknown confounders, and a randomized controlled trial is needed to make claims of causality. The study population consisted of US veterans and included a low proportion of women. As a result, the findings may not be generalizable to other patient populations. Finally, prescription dispensing data, used as a proxy for pharmacotherapy use, do not necessarily reflect actual medication use.

Conclusions

This study is among the first to examine associations between thermal therapy and specialty pain treatment and analgesic pharmacotherapy use among US veterans. Although the retrospective cohort study design does not allow causal inferences regarding the efficacy of thermal therapy for veterans with chronic musculoskeletal pain, confidence in the findings is strengthened by methodological and statistical control of known confounders. Future trials employing experimental designs are needed to further clarify the clinical and health systems benefits of thermal therapy for musculoskeletal pain syndromes.

Growing recognition of the limitations of long-term opioid therapy for chronic noncancer pain has highlighted the importance of nonpharmacologic approaches to pain treatment.^1,2 These treatments are varied and may include psychological and behavioral therapies (eg, cognitive behavioral therapy for chronic pain), exercise and movement therapies (eg, yoga), and manual therapies (eg, chiropractic). Body surface cold therapy, while predominantly used to reduce postoperative pain and inflammation,^3,4 pain subsequent to acute musculoskeletal injury,⁵ and pain related to muscle soreness,⁶ is a nonpharmacologic treatment that has shown pain-reducing benefits for chronic low back pain and knee osteoarthritis, as has its counterpart, superficial heat therapy.^7-9 Heat therapy has also been shown to improve strength, flexibility, and activities of daily living in patients with chronic low back pain.^10,11 Cold and heat therapies are commonly used complementarily. Cold therapies aim to reduce blood flow and inflammation and are often used immediately following trauma to an affected area, whereas heat therapies increase blood flow and metabolic activity and are commonly used to promote healing.⁵

Heat and cold therapies (also known as thermal therapies) benefit resource-limited health care systems, as most devices require a single expenditure and can be self-administered by patients at home as part of their pain self-management plan. In addition, these pain self-management tools may attenuate the need for more expensive specialty pain care and ongoing analgesic pharmacotherapy. Despite their potential, few studies have characterized the benefits of thermal therapies for patients with heterogeneous chronic pain syndromes.

The purpose of this retrospective cohort study was to examine the potential clinical and health system benefits of patient-administered thermal therapy. Our primary hypothesis was that patients with chronic musculoskeletal pain who received a thermal therapy self-management device would have fewer days of opioid prescriptions compared with a sample of matched control patients. Secondarily, we hypothesized that patients who received a thermal therapy device would have lower utilization of specialty pain care, fewer potentially hazardous opioid prescriptions (eg, high-dose opioid therapy and concurrent opioid and benzodiazepine prescriptions), fewer prescriptions for nonopioid analgesic medications, and decreased pain intensity when compared with matched controls.

Methods

This retrospective cohort study compared pain pharmacotherapy, pain treatment utilization, and pain intensity outcomes between patients who received a thermal therapy device and matched patients who did not. The study was approved by the US Department of Veterans Affairs (VA) Portland Health Care System Institutional Review Board and was granted a waiver of informed consent to access patient electronic health records (EHRs).

Pain Care

The VA uses ThermaZone thermal therapy devices (Innovative Medical Equipment) for chronic pain treatment. The device uses thermoelectric technology to provide point-of-contact cooling and heating therapy through site-specific pads (eg, ankle, knee, hip, back, elbow, shoulder). Patients place pads on sites where they experience pain, and temperature regulated water circulates through the device and to the pad, providing consistent, localized thermal therapy. The pads range in temperature from 1 °C to 52 °C, and temperatures are self-monitored and controlled by the patient.

Standard pain care in this study followed the VA stepped model of pain care, which builds on a foundation of patient education for pain self-management approaches (eg, exercise, mindfulness, relaxation, social support).¹² According to the VA stepped model of pain care, all patients with chronic pain should engage in these foundational self-management approaches. However, some patients require more intensive care. The VA stepped-up treatment engages primary and specialty care services—such as physical therapy, pharmacy, complementary and integrative health approaches, mental health, and substance use services—and, when indicated, may escalate treatment to interdisciplinary pain teams or tertiary pain centers. In this retrospective cohort study, treatment patients received a thermal therapy device and standard of care, whereas control patients received standard care only.

Sample Selection

Eligible patients were aged ≥ 18 years, had a musculoskeletal pain diagnosis documented in the EHR in the year prior to thermal therapy device receipt (or during the same period for a treatment patient’s matched control), and were enrolled in VA health care during the study period. Patients who died during the study period were excluded. Treatment patients received a thermal therapy device from the VA between January 1, 2017, and December 31, 2018, when complete data on thermal therapy devices were available. For control patients, the VA Corporate Data Warehouse (CDW) was used to identify VA patients with characteristics similar to those of treated patients.

We modeled the probability that a patient would receive a thermal therapy device using logistic regression. Predictor variables were measured in the year prior to device receipt and included variables associated with pain treatment utilization and analgesic pharmacotherapy receipt, as recommended by Brookhart et al.¹³ These included age, sex, race, ethnicity, VA service-connected disability status, comorbidities, receipt of medications for opioid use disorder, pain diagnoses, mental health diagnoses, and substance use disorder diagnoses.^14-19

The resulting propensity scores (eg, predicted probabilities) were used to match treatment patients 1:1 with control patients using a nearest-neighbor matching algorithm.²⁰ This procedure matches a control patient with the closest propensity score to that of the corresponding treatment patient. An exact match on VA facility was required (eg, treatment patients and matched controls received care at the same VA facility). Standardized differences were used to assess covariate balance between the matched groups, and kernel density plots of propensity scores tested for sufficient overlap.²¹ Control patients were selected from a pool of 1,150,149 patients.

Study Variables

The index date was the date the thermal therapy device was released to treatment patients or the same date for the matched controls. Data were extracted from the CDW over a 24-month period: 12 months prior to the index date through 12 months afterwards. Collecting data in the 12 months prior to treatment initiation allowed us to adjust for covariates and provided greater precision, as recommended for observational study designs.²²

Treatment conditions were defined dichotomously as receipt vs nonreceipt of a thermal therapy device. The primary outcome was the number of days of opioid use in the 12 months following the index date. Additional outcomes included days of high-dose opioid therapy (≥ 50 mg morphine equivalent [MME] daily), concurrent opioid and benzodiazepine prescriptions, and nonopioid analgesic pharmacotherapy (eg, nonsteroidal anti-inflammatory drugs, acetaminophen, muscle relaxants). All prescription data were based on medication fills obtained from VA pharmacy records. Additional outcomes included the number of visits to physical therapy, occupational therapy, physical medicine and rehabilitation, and interdisciplinary pain clinics, including interventional pain medicine.

Pain intensity ratings were collected as part of routine VA care using a numeric scale from 0 (no pain) to 10 (worst possible pain). Pain intensity trajectories were computed using all available EHR-derived pain intensity score data for each patient in the 12 months prior to and following the index date.

Covariates were extracted from the EHR and evaluated in the year prior to the index date, unless otherwise noted. They included age at the index date; self-reported sex, and race and ethnicity; service-connected disability status (disability awarded as a result of military service-related trauma or injury); Charlson Comorbidity Index; and diagnoses of opioid use disorder, alcohol use disorder, other substance use disorder, mood disorder, posttraumatic stress disorder, other anxiety disorder, psychotic disorder, neuropathic pain, and headache pain.²³ All diagnoses were coded as yes if identified in the EHR as a focus of treatment during any clinical encounter in the year prior to the index date or no if not identified as a focus of treatment.

The number of days patients had been living with pain was calculated and defined as the number of days from the first pain diagnosis available in a patient’s EHR to the index date. Finally, the number of pain-related surgeries (eg, surgeries with ≥ 1 pain diagnoses associated with the clinical encounter) and average pain intensity were computed for the pre- and postindex date evaluation periods and included as model covariates.

Statistical Analyses

For the 4 pharmacotherapy and 4 nonpharmacologic treatment usage outcomes, we tested the fit of linear models and several models with count distributions using the Bayesian information criterion.²⁴ Count distributions included Poisson, zero-inflated Poisson, negative binomial, and zero-inflated negative binomial. With 1 exception (days of high-dose opioid use), a negative binomial distribution best fit the data. For days of high-dose opioid use, a Gaussian distribution best fit the data.

Eight separate mixed-effects regression analyses compared changes in each outcome from the 12-month preindex period through the 12-month postindex period between treatment and control patients by testing the Time × Treatment interaction. This approach statistically accounts for observed pretreatment differences in outcome variables. Statistics for the main effects of time and treatment are also presented. To reduce bias, models controlled for covariates specified previously.

For pain intensity, we used random-effects growth modeling to quantify both fixed and random effects of pain intensity at the index date (eg, the model intercept), which estimates pain at the time of treatment initiation, and change in pain during the 12 months following the index date (eg, the model slope), which characterizes the trajectory of pain intensity ratings.²⁵ The model included piecewise components of pain score trajectories in the 12 months prior to the index date and in the 12 months following the index date. Several types of change for the 12-month postindex observation period were explored—including quadratic and cubic curvilinear change. A linear model for change in pain over time provided the best fit based on the Bayesian information criterion and parsimony of model parameters.²⁶ We report estimates of change in pain over time in monthly intervals for ease of interpretation. However, models used all individual pain scores rather than computing monthly averages when > 1 pain score was available within a month, as recommended in previous research.²⁷ This approach makes optimal use of all available data. Both random effects (intercept and slope) were regressed onto the set of covariates described previously.

This study used data available in the EHR over the 24-month observation period. We characterize the density (eg, frequency) of all outcome variables by treatment condition in the Appendix. Because the hypotheses were directional, the authors used a 2-sided α = 0.10 and applied a Bonferroni correction for the 9 statistical tests performed, resulting in an adjusted α of 0.01. Treatment utilization and pharmacotherapy outcome analyses were performed in Stata, version 16.1. Random-effects growth modeling of pain score trajectories was performed using Mplus, version 8.8.

Results

There were 2182 patients in the treatment group and 2182 matched controls. The mean (SD) age was 54 (15) years; 81% were male, and about two-thirds (68%) identified as White and non-Hispanic. Mental health comorbidities were common, with > 40% of the sample having diagnoses of a mood disorder and/or posttraumatic stress disorder. Nearly all patients (90%) had VA service-connected disability ratings. Among patients with chronic musculoskeletal pain, 8% had comorbid neuropathic pain and 14% had headache. The mean (SD) duration of chronic pain across both patient groups was 3416 (2016) days, or about 9.4 years (Table 1).

Pharmacotherapy

High-dose opioid use (> 50 MME daily dose), days of opioid use, and concurrent opioid and benzodiazepine use decreased for all patients from the pre- to posttreatment period (Table 2). However, high-dose opioid use (Time × Treatment interaction, 3.24; 99% CI, 0.34 to 6.14) (Figure 1A) and concurrent opioid and benzodiazepine use (Time × Treatment interaction, 0.76; 99% CI, 0.67 to 0.86) (Figure 1B) had a larger decrease for the treatment vs matched control group. Treatment and matched control patients had comparable reductions in days of opioid use (Time × Treatment interaction, 0.98; 99% CI, 0.91 to 1.05) (Figure 1C). Neither group showed changes in nonopioid analgesic pharmacotherapy over time (main effect of time, incidence rate ratio [IRR], 1.03; 99% CI, 0.99 to 1.07; Time × Treatment interaction, 0.95; 99% CI, 0.90 to 1.01) (Figure 1D).

Nonpharmacologic Pain Treatment

The number of physical therapy and pain clinic visits declined for treatment patients and increased slightly for matched control patients (Figure 2A and 2B). For occupational therapy visits, neither group showed changes over time (main effect of time IRR, 1.03; 99% CI, 0.83 to 1.22; Time × Treatment interaction, 1.20; 99% CI, 0.93 to 1.46) (Figure 2C). For physical medicine and rehabilitation visits, both groups decreased use over time (main effect of time IRR, 0.78; 99% CI, 0.66 to 0.90), but this decrease did not differ between treatment and control patients (Time × Treatment interaction, 1.16; 99% CI, 0.94 to 1.37) (Figure 2D).

Pain Intensity

Pain intensity decreased for both groups by an estimated 0.02 points per month (99% CI, -0.04 to -0.01; P < .01), or 0.24 points over the 12-month postindex follow-up period (Figure 3). There were no statistically significant differences between treatment and control patients in pain intensity changes over the follow-up period (B = -0.02; 99% CI, -0.06 to 0.02; P = .15).

Discussion

Patients with musculoskeletal pain who received a thermal therapy device showed a larger decline in use of some specialty pain treatments, including physical therapy and specialty pain clinic services, when compared with matched control patients. One possible explanation is that patients who used the device may have had their pain adequately managed and thus required less specialty pain care. However, the absence of clinically significant changes in pain intensity over time suggests that pain intensity alone did not account for the observed changes in pain treatment use. We were unable to measure constructs of pain interference or functioning, which may be better predictors of functional restoration, as these data are not routinely collected within the VA and documented in the EHR. Future studies could clarify these findings by including measures of pain interference and functioning.

Although the overall declines in physical therapy and specialty pain clinic use associated with thermal therapy were modest (< 1 visit per patient), the impact of these reductions can be profound. In resource-limited health care settings, even small reductions in high-cost care utilization could be of great value in that health systems could offset costs associated with treating chronic pain without compromising quality of care or key clinical outcomes, such as pain intensity. This study, however, did not include a cost analysis. Future studies should incorporate formal cost analyses to quantify cost offsets that may result from decreased specialty pain treatment use.

Patients who received thermal therapy devices did not show clinically meaningful reductions in pain intensity over time, defined as reductions in pain intensity of 1.7 to 2.0 on a 0 to 10 scale.^28,29 This finding is consistent with prior research that demonstrates relatively stable pain intensity self-ratings longitudinally by patients with chronic pain diagnoses, when assessed in the context of usual clinical care.³⁰ This finding, however, is inconsistent with prior literature that demonstrates pain-reducing benefits of thermal therapy for low back pain and knee osteoarthritis.^7-9

In this study, pain intensity ratings were derived from the EHR during routine outpatient clinical encounters and not at the time thermal therapy was self-administered, as has been done in prior clinical trials.^7-9 Pain location was not specified at the time of pain ratings, and it is possible that patients may have been endorsing pain in areas of the body that had not been treated by thermal therapy. Patient-level variability in pain intensity ratings (eg, within-patient range over time) was not examined, although prior research indicates substantial variability.³⁰ While average pain intensity ratings in the current study did not change, an examination of patient variability warrants further study, as a narrowing of pain intensity ratings can be perceived, by patients, as demonstrable improvement and has been associated with improved physical and psychological outcomes.³¹ Furthermore, pain intensity does not characterize physical or emotional functioning that can be captured with more comprehensive validated measures, some of which are recommended outcomes in pain clinical trials.³²

Our findings point to reductions in all forms of opioid use across both treatment and control patients. Data from the VA and in the US more generally point to downward trends in opioid prescribing during the study period.³³ This decline is likely due to increased use of risk mitigation approaches, such as routine urine drug screens and review of prescription drug monitoring databases.³⁴ These state-level databases track prescribing of controlled substances, including opioids and benzodiazepines, within a state. Implementation of these practices has been associated with declines in higher risk opioid prescribing.³⁴ Findings from this study further point to associations of reduced higher risk opioid use among patients who received thermal therapy devices. In the full sample of patients, reductions in days of opioid use, high-dose opioid use, and co-use of opioids and benzodiazepines were observed across all patients, with greater reductions observed in high-dose opioid use and concurrent opioid and benzodiazepine use among patients who received a thermal therapy device. Experimental studies indicate that the endogenous opioid system is implicated in pain relief and activated by thermal therapies. ³⁵ Differential reductions in higher-risk opioid use among patients who received thermal therapy devices in our study may be associated with endogenous opioid activation, though this was not specifically measured. It is also unclear whether thermal therapy was provided by clinicians in the context of opioid tapering or other risk mitigation efforts, or patients reduced higher risk opioid use of their own volition. Prior research has identified both patient- and clinician-initiated opioid tapering and discontinuation.³⁶ While a thorough explication of opioid dose reduction was beyond the scope of this study, future qualitative work could help explain potential benefits of thermal therapy in the context of analgesic pharmacotherapy use, including opioid medications.

Limitations

The extent to which patients used the thermal therapy device could not be measured; therefore, device receipt was used as a proxy for use. However, it was not possible to determine whether the frequency and duration of device use was associated with study outcomes. Treatment and control groups demonstrated some differences in outcome variables at the index date. Potential known biases were addressed using propensity score matching procedures and statistical procedures that controlled for patient demographic and clinical characteristics, as well as pretreatment values of all outcome variables. Nevertheless, as an observational study, this analysis cannot account for all known and unknown confounders, and a randomized controlled trial is needed to make claims of causality. The study population consisted of US veterans and included a low proportion of women. As a result, the findings may not be generalizable to other patient populations. Finally, prescription dispensing data, used as a proxy for pharmacotherapy use, do not necessarily reflect actual medication use.

Conclusions

This study is among the first to examine associations between thermal therapy and specialty pain treatment and analgesic pharmacotherapy use among US veterans. Although the retrospective cohort study design does not allow causal inferences regarding the efficacy of thermal therapy for veterans with chronic musculoskeletal pain, confidence in the findings is strengthened by methodological and statistical control of known confounders. Future trials employing experimental designs are needed to further clarify the clinical and health systems benefits of thermal therapy for musculoskeletal pain syndromes.

Self-reported penicillin allergies are common, with a prevalence of about 10% of patients, according to the Centers for Disease Control and Prevention (CDC).¹ However, only about 1% of patients have a true immunoglobulin E (IgE)-mediated allergy. This issue is often further complicated by inaccurate classification of nonallergic adverse effects as an allergy, resulting in incomplete allergy documentation in the electronic health record (EHR). The cross-reactivity rate with cephalosporins (Β-lactam antibiotics) in patients reporting a penicillin allergy is < 1%, which suggests that many patients with reported penicillin allergies can safely receive them.² Despite this, patients with self-reported penicillin allergies often receive non–Β-lactam antibiotic agents, which may be associated with an increased risk of adverse drug reactions (ADRs), increased health care costs, and inferior clinical outcomes.³

Several strategies are recommended to assess patients with self-reported penicillin allergies. According to the CDC, evaluating a patient who reports a penicillin or other Β-lactam antibiotic allergy involves 3 steps: (1) obtaining a thorough medical history, including previous exposures to penicillin or other Β-lactam antibiotic; (2) performing a skin test using the penicillin major and minor determinants; and (3) among those who have a negative penicillin skin test, performing an observed oral challenge with 250 mg amoxicillin before proceeding directly to treatment with the indicated Β-lactam therapy.⁴

Most existing clinical guidance for assessing patients with self-reported penicillin allergies stems from site-specific policies and primarily focuses on oral amoxicillin challenges or penicillin skin testing (PST). However, performing these tests may not be feasible at all facilities due to time constraints and lack of allergists. Therefore, alternative strategies are necessary, such as conducting detailed patient interviews. Few studies have evaluated switching to Β-lactam agents following a penicillin allergy interview alone. However, with thorough patient histories and detailed interviews, patients with reported penicillin allergies can safely use Β-lactam antibiotics.⁵ Implementing this procedure provides a cost-savings opportunity by not having to administer additional antibiotics for testing in addition to improving antibiotic stewardship.

The Memphis Veterans Affairs Medical Center (MVAMC) created the Allergy to Β-Lactam Evaluation (ABLE) process to clarify and remove penicillin allergies. The process involves conducting a thorough chart review and patient interview followed by completion of a note template that provides recommendations about patient allergies and Β-lactam prescribing. Mitchell et al found that the pharmacist-led process to be beneficial for addressing Β-lactam allergy clearance.⁶ As a result, the ABLE process was implemented at several other US Department of Veterans Affairs (VA) medical centers (VAMCs). Using the ABLE template, the purpose of this study was to evaluate the impact of a pharmacist-led penicillin allergy initiative on penicillin allergy delabeling with an interview process alone.

Methods

Prior to ABLE process implementation, there were no standardized procedures for documenting allergy histories. ABLE was implemented at the Robley Rex VAMC (RRVAMC) in November 2022. During the interview phase, patients were initially identified during admission via TheraDoc as having either a penicillin allergy or ADR. The infectious disease pharmacist or pharmacy resident interviewed patients with documented penicillin allergies or ADRs using a standardized questionnaire (eAppendix 1). Not all identified patients could be interviewed. Patients currently receiving an antibiotic were prioritized for interviews. Patients were excluded if they declined or were unable to be interviewed, although a patient’s caregiver(s) could be interviewed in person or via telephone, if the patient was not available.

Following the interview, pharmacists used guidance from the ABLE process in addition to a detailed EHR review to determine whether the patient was eligible for an allergy update or removal and/or switch to a Β-lactam antibiotic (Figure). If eligible for modification, the interviewing pharmacist made the necessary changes. A templated process note with patient-specific recommendations was entered into the Computerized Patient Record System (CPRS) and the primary care team attending physician was added as an additional signer to be alerted in the system note (eAppendix 2).

This single-center, retrospective cohort study involved review of CPRS notes and clinical interviews in the interviewed group. Hospitalized patients at the RRVAMC aged ≥ 18 years with a documented penicillin allergy or ADR were included. The historical control group consisted of patients admitted between October 31, 2019, and October 31, 2022, and the intervention group consisted of patients admitted between November 1, 2022, and March 1, 2023. Patients in the historical control group were matched 1:1 to the intervention group for penicillin allergy severity (allergy [IgE-mediated], unknown, adverse effect, severe cutaneous or other non–IgE-mediated reaction) and whether they received a noncarbapenem non–Β-lactam antibiotic.

The primary outcome was the number of patient allergies/ADRs removed or changed on patient profiles regardless of whether their antibiotic regimen was changed. This outcome was further assessed by evaluating the number of patient allergies or ADRs removed or changed on patient profiles with or without a change in antibiotic regimen. Primary outcomes were analyzed using χ² and/ or Fisher exact tests, as appropriate to determine statistically significant differences between the interviewed group and the historical control.

Results

Seventy patients were included: 35 patients in the interviewed group and 35 patients in the historical control group, respectively. Both groups had a mean age of 72 years and predominantly included White male patients (Table 1). Following the interview, the allergy profile was modified for 6 patients (17%) in the interview group vs 0 patients in the control group (P = .03) (Table 2). The primary outcome was analyzed separately regardless of an antibiotic regimen change. There was not a statistically significant difference between groups when assessing patients for change in therapy (P > .99). All 6 patients with an allergy profile modification had no change in antibiotic regimen.

Discussion

This study suggests the ABLE process may be a valuable tool for adjusting penicillin allergies or ADRs within patient EHRs. In the interview group, allergies were modified in 6 (17%) patients while no patients in the control group had allergy modifications. Of the 6 allergy profile modifications, 4 allergy labels were changed from an allergy to an ADR. These patients were cleared to receive future Β-lactam antibiotics after clinicians recognized the lack of a true IgE-mediated allergic reaction. In addition, 2 of the modified allergy profiles removed the allergy designation. Although this represents a small subset of interviewed patients, it illustrates the clinical effectiveness of an interview process alone to remove penicillin allergy designations.

Previous research has assessed the impact of pharmacist intervention on penicillin allergy clarification. Mitchell et al implemented a pharmacist-driven Β-lactam allergy assessment and penicillin allergy clinic (PAC) at the MVAMC with the goal of evaluating its impact on allergy clearance. In their study, clinical pharmacy specialists evaluated patients with Β-lactam allergies, and those deemed eligible were later seen in the PAC. Among the 246 patients evaluated using the Β-lactam allergy assessment alone and who were not seen in the PAC, 25% had their penicillin allergy removed following a detailed assessment.⁶

Song et al evaluated the effectiveness and feasibility of a pharmacist-driven penicillin allergy delabeling pilot program without skin testing or oral challenges. Patients with penicillin allergies were interviewed by a pharmacy resident using a standardized checklist. Among the 66 patients interviewed, 12 (18%) met the criteria for delabeling and consented to removal of their allergy.⁷ The delabeling rates in these 2 studies are similar to the 17% rate of allergy modification in our study, although this study is the only one to compare results to a historical control group.

Harper et al evaluated the impact of a penicillin allergy assessment, including penicillin skin testing and oral amoxicillin challenges, on delabeling penicillin allergies. Pharmacists completed a penicillin allergy assessment and performed penicillin skin testing and/or oral amoxicillin challenges for eligible patients. Of 35 patients, 31 (89%) had their penicillin allergies delabeled in the EHR.⁸ The rate of penicillin allergy delabeling in Harper et al was likely higher than that seen in our study due to the use of oral challenge and skin testing. Regardless, a detailed penicillin allergy interview alone was effective at RRVAMC, resulting in a significant rate of allergy removal or change. This supports the use of detailed penicillin allergy assessments in settings where penicillin skin testing or oral challenges may not be feasible.

Mann et al demonstrated the effectiveness of penicillin allergy assessments in switching eligible patients to Β-lactam antibiotics. Their single-center, prospective study assessed the impact of a pharmacist-driven detailed penicillin allergy interview initiative. Interviews that evaluated potential changes to allergy profiles were conducted with 175 patients. Of these patients, 135 (77.1%) were on antimicrobial therapy and 42 (31.1%) patients receiving therapy met criteria to switch to a noncarbapenem Β-lactam antibiotic. Thirty-one patients (73.8%) switched with no signs or symptoms of intolerance demonstrating that an interview can be a valuable tool for antibiotic optimization, specifically in patients with penicillin allergy.⁹ No patients in our study switched antibiotic therapy, likely because only a small number of patients were eligible for transition to a noncarbapenem Β-lactam antibiotic. In the Mann et al study, non–Β-lactam antibiotics, such as fluoroquinolones and carbapenems, accounted for > 75% of the antibiotics used.

Limitations

The sample size of this study was small and its duration was short. There is a risk for selection bias as not all identified patients were able to be interviewed while admitted, but patients on antibiotics were prioritized as they were most likely to directly benefit during their current admission from a modification of their allergy. Most patients in the study were White and male, which may limit the generalizability of the results. Additionally, recommendations regarding antibiotic changes were primarily communicated to the treatment team based on a templated note in CPRS alone. Therefore, implementation of these recommendations largely relied upon nonverbal communication. Direct pharmacist-physician communication could have led to a larger impact on antimicrobial therapy changes. The interviewer’s participation in daily rounds with time allotted to discuss this topic can be considered in the future to improve these processes.

Conclusions

This study found that the ABLE process identified patients for penicillin allergy delabeling. With the high prevalence of inaccurate penicillin allergy documentation, this tool offers VA health care systems a way to empower pharmacists in allergy clarification, leading to improvements in antibiotic stewardship. Although the sample size was small, the ABLE process may provide a framework for VA clinicians. Future research has the potential to demonstrate the practicality and effectiveness this pharmacist-led penicillin allergy interview process can offer clinicians.

Self-reported penicillin allergies are common, with a prevalence of about 10% of patients, according to the Centers for Disease Control and Prevention (CDC).¹ However, only about 1% of patients have a true immunoglobulin E (IgE)-mediated allergy. This issue is often further complicated by inaccurate classification of nonallergic adverse effects as an allergy, resulting in incomplete allergy documentation in the electronic health record (EHR). The cross-reactivity rate with cephalosporins (Β-lactam antibiotics) in patients reporting a penicillin allergy is < 1%, which suggests that many patients with reported penicillin allergies can safely receive them.² Despite this, patients with self-reported penicillin allergies often receive non–Β-lactam antibiotic agents, which may be associated with an increased risk of adverse drug reactions (ADRs), increased health care costs, and inferior clinical outcomes.³

Several strategies are recommended to assess patients with self-reported penicillin allergies. According to the CDC, evaluating a patient who reports a penicillin or other Β-lactam antibiotic allergy involves 3 steps: (1) obtaining a thorough medical history, including previous exposures to penicillin or other Β-lactam antibiotic; (2) performing a skin test using the penicillin major and minor determinants; and (3) among those who have a negative penicillin skin test, performing an observed oral challenge with 250 mg amoxicillin before proceeding directly to treatment with the indicated Β-lactam therapy.⁴

Most existing clinical guidance for assessing patients with self-reported penicillin allergies stems from site-specific policies and primarily focuses on oral amoxicillin challenges or penicillin skin testing (PST). However, performing these tests may not be feasible at all facilities due to time constraints and lack of allergists. Therefore, alternative strategies are necessary, such as conducting detailed patient interviews. Few studies have evaluated switching to Β-lactam agents following a penicillin allergy interview alone. However, with thorough patient histories and detailed interviews, patients with reported penicillin allergies can safely use Β-lactam antibiotics.⁵ Implementing this procedure provides a cost-savings opportunity by not having to administer additional antibiotics for testing in addition to improving antibiotic stewardship.

The Memphis Veterans Affairs Medical Center (MVAMC) created the Allergy to Β-Lactam Evaluation (ABLE) process to clarify and remove penicillin allergies. The process involves conducting a thorough chart review and patient interview followed by completion of a note template that provides recommendations about patient allergies and Β-lactam prescribing. Mitchell et al found that the pharmacist-led process to be beneficial for addressing Β-lactam allergy clearance.⁶ As a result, the ABLE process was implemented at several other US Department of Veterans Affairs (VA) medical centers (VAMCs). Using the ABLE template, the purpose of this study was to evaluate the impact of a pharmacist-led penicillin allergy initiative on penicillin allergy delabeling with an interview process alone.

Methods

Prior to ABLE process implementation, there were no standardized procedures for documenting allergy histories. ABLE was implemented at the Robley Rex VAMC (RRVAMC) in November 2022. During the interview phase, patients were initially identified during admission via TheraDoc as having either a penicillin allergy or ADR. The infectious disease pharmacist or pharmacy resident interviewed patients with documented penicillin allergies or ADRs using a standardized questionnaire (eAppendix 1). Not all identified patients could be interviewed. Patients currently receiving an antibiotic were prioritized for interviews. Patients were excluded if they declined or were unable to be interviewed, although a patient’s caregiver(s) could be interviewed in person or via telephone, if the patient was not available.

Following the interview, pharmacists used guidance from the ABLE process in addition to a detailed EHR review to determine whether the patient was eligible for an allergy update or removal and/or switch to a Β-lactam antibiotic (Figure). If eligible for modification, the interviewing pharmacist made the necessary changes. A templated process note with patient-specific recommendations was entered into the Computerized Patient Record System (CPRS) and the primary care team attending physician was added as an additional signer to be alerted in the system note (eAppendix 2).

This single-center, retrospective cohort study involved review of CPRS notes and clinical interviews in the interviewed group. Hospitalized patients at the RRVAMC aged ≥ 18 years with a documented penicillin allergy or ADR were included. The historical control group consisted of patients admitted between October 31, 2019, and October 31, 2022, and the intervention group consisted of patients admitted between November 1, 2022, and March 1, 2023. Patients in the historical control group were matched 1:1 to the intervention group for penicillin allergy severity (allergy [IgE-mediated], unknown, adverse effect, severe cutaneous or other non–IgE-mediated reaction) and whether they received a noncarbapenem non–Β-lactam antibiotic.

The primary outcome was the number of patient allergies/ADRs removed or changed on patient profiles regardless of whether their antibiotic regimen was changed. This outcome was further assessed by evaluating the number of patient allergies or ADRs removed or changed on patient profiles with or without a change in antibiotic regimen. Primary outcomes were analyzed using χ² and/ or Fisher exact tests, as appropriate to determine statistically significant differences between the interviewed group and the historical control.

Results

Seventy patients were included: 35 patients in the interviewed group and 35 patients in the historical control group, respectively. Both groups had a mean age of 72 years and predominantly included White male patients (Table 1). Following the interview, the allergy profile was modified for 6 patients (17%) in the interview group vs 0 patients in the control group (P = .03) (Table 2). The primary outcome was analyzed separately regardless of an antibiotic regimen change. There was not a statistically significant difference between groups when assessing patients for change in therapy (P > .99). All 6 patients with an allergy profile modification had no change in antibiotic regimen.

Discussion

This study suggests the ABLE process may be a valuable tool for adjusting penicillin allergies or ADRs within patient EHRs. In the interview group, allergies were modified in 6 (17%) patients while no patients in the control group had allergy modifications. Of the 6 allergy profile modifications, 4 allergy labels were changed from an allergy to an ADR. These patients were cleared to receive future Β-lactam antibiotics after clinicians recognized the lack of a true IgE-mediated allergic reaction. In addition, 2 of the modified allergy profiles removed the allergy designation. Although this represents a small subset of interviewed patients, it illustrates the clinical effectiveness of an interview process alone to remove penicillin allergy designations.

Previous research has assessed the impact of pharmacist intervention on penicillin allergy clarification. Mitchell et al implemented a pharmacist-driven Β-lactam allergy assessment and penicillin allergy clinic (PAC) at the MVAMC with the goal of evaluating its impact on allergy clearance. In their study, clinical pharmacy specialists evaluated patients with Β-lactam allergies, and those deemed eligible were later seen in the PAC. Among the 246 patients evaluated using the Β-lactam allergy assessment alone and who were not seen in the PAC, 25% had their penicillin allergy removed following a detailed assessment.⁶

Song et al evaluated the effectiveness and feasibility of a pharmacist-driven penicillin allergy delabeling pilot program without skin testing or oral challenges. Patients with penicillin allergies were interviewed by a pharmacy resident using a standardized checklist. Among the 66 patients interviewed, 12 (18%) met the criteria for delabeling and consented to removal of their allergy.⁷ The delabeling rates in these 2 studies are similar to the 17% rate of allergy modification in our study, although this study is the only one to compare results to a historical control group.

Harper et al evaluated the impact of a penicillin allergy assessment, including penicillin skin testing and oral amoxicillin challenges, on delabeling penicillin allergies. Pharmacists completed a penicillin allergy assessment and performed penicillin skin testing and/or oral amoxicillin challenges for eligible patients. Of 35 patients, 31 (89%) had their penicillin allergies delabeled in the EHR.⁸ The rate of penicillin allergy delabeling in Harper et al was likely higher than that seen in our study due to the use of oral challenge and skin testing. Regardless, a detailed penicillin allergy interview alone was effective at RRVAMC, resulting in a significant rate of allergy removal or change. This supports the use of detailed penicillin allergy assessments in settings where penicillin skin testing or oral challenges may not be feasible.

Mann et al demonstrated the effectiveness of penicillin allergy assessments in switching eligible patients to Β-lactam antibiotics. Their single-center, prospective study assessed the impact of a pharmacist-driven detailed penicillin allergy interview initiative. Interviews that evaluated potential changes to allergy profiles were conducted with 175 patients. Of these patients, 135 (77.1%) were on antimicrobial therapy and 42 (31.1%) patients receiving therapy met criteria to switch to a noncarbapenem Β-lactam antibiotic. Thirty-one patients (73.8%) switched with no signs or symptoms of intolerance demonstrating that an interview can be a valuable tool for antibiotic optimization, specifically in patients with penicillin allergy.⁹ No patients in our study switched antibiotic therapy, likely because only a small number of patients were eligible for transition to a noncarbapenem Β-lactam antibiotic. In the Mann et al study, non–Β-lactam antibiotics, such as fluoroquinolones and carbapenems, accounted for > 75% of the antibiotics used.

Limitations

The sample size of this study was small and its duration was short. There is a risk for selection bias as not all identified patients were able to be interviewed while admitted, but patients on antibiotics were prioritized as they were most likely to directly benefit during their current admission from a modification of their allergy. Most patients in the study were White and male, which may limit the generalizability of the results. Additionally, recommendations regarding antibiotic changes were primarily communicated to the treatment team based on a templated note in CPRS alone. Therefore, implementation of these recommendations largely relied upon nonverbal communication. Direct pharmacist-physician communication could have led to a larger impact on antimicrobial therapy changes. The interviewer’s participation in daily rounds with time allotted to discuss this topic can be considered in the future to improve these processes.

Conclusions

This study found that the ABLE process identified patients for penicillin allergy delabeling. With the high prevalence of inaccurate penicillin allergy documentation, this tool offers VA health care systems a way to empower pharmacists in allergy clarification, leading to improvements in antibiotic stewardship. Although the sample size was small, the ABLE process may provide a framework for VA clinicians. Future research has the potential to demonstrate the practicality and effectiveness this pharmacist-led penicillin allergy interview process can offer clinicians.

Self-reported penicillin allergies are common, with a prevalence of about 10% of patients, according to the Centers for Disease Control and Prevention (CDC).¹ However, only about 1% of patients have a true immunoglobulin E (IgE)-mediated allergy. This issue is often further complicated by inaccurate classification of nonallergic adverse effects as an allergy, resulting in incomplete allergy documentation in the electronic health record (EHR). The cross-reactivity rate with cephalosporins (Β-lactam antibiotics) in patients reporting a penicillin allergy is < 1%, which suggests that many patients with reported penicillin allergies can safely receive them.² Despite this, patients with self-reported penicillin allergies often receive non–Β-lactam antibiotic agents, which may be associated with an increased risk of adverse drug reactions (ADRs), increased health care costs, and inferior clinical outcomes.³

Several strategies are recommended to assess patients with self-reported penicillin allergies. According to the CDC, evaluating a patient who reports a penicillin or other Β-lactam antibiotic allergy involves 3 steps: (1) obtaining a thorough medical history, including previous exposures to penicillin or other Β-lactam antibiotic; (2) performing a skin test using the penicillin major and minor determinants; and (3) among those who have a negative penicillin skin test, performing an observed oral challenge with 250 mg amoxicillin before proceeding directly to treatment with the indicated Β-lactam therapy.⁴

Most existing clinical guidance for assessing patients with self-reported penicillin allergies stems from site-specific policies and primarily focuses on oral amoxicillin challenges or penicillin skin testing (PST). However, performing these tests may not be feasible at all facilities due to time constraints and lack of allergists. Therefore, alternative strategies are necessary, such as conducting detailed patient interviews. Few studies have evaluated switching to Β-lactam agents following a penicillin allergy interview alone. However, with thorough patient histories and detailed interviews, patients with reported penicillin allergies can safely use Β-lactam antibiotics.⁵ Implementing this procedure provides a cost-savings opportunity by not having to administer additional antibiotics for testing in addition to improving antibiotic stewardship.

The Memphis Veterans Affairs Medical Center (MVAMC) created the Allergy to Β-Lactam Evaluation (ABLE) process to clarify and remove penicillin allergies. The process involves conducting a thorough chart review and patient interview followed by completion of a note template that provides recommendations about patient allergies and Β-lactam prescribing. Mitchell et al found that the pharmacist-led process to be beneficial for addressing Β-lactam allergy clearance.⁶ As a result, the ABLE process was implemented at several other US Department of Veterans Affairs (VA) medical centers (VAMCs). Using the ABLE template, the purpose of this study was to evaluate the impact of a pharmacist-led penicillin allergy initiative on penicillin allergy delabeling with an interview process alone.

Methods

Prior to ABLE process implementation, there were no standardized procedures for documenting allergy histories. ABLE was implemented at the Robley Rex VAMC (RRVAMC) in November 2022. During the interview phase, patients were initially identified during admission via TheraDoc as having either a penicillin allergy or ADR. The infectious disease pharmacist or pharmacy resident interviewed patients with documented penicillin allergies or ADRs using a standardized questionnaire (eAppendix 1). Not all identified patients could be interviewed. Patients currently receiving an antibiotic were prioritized for interviews. Patients were excluded if they declined or were unable to be interviewed, although a patient’s caregiver(s) could be interviewed in person or via telephone, if the patient was not available.

Following the interview, pharmacists used guidance from the ABLE process in addition to a detailed EHR review to determine whether the patient was eligible for an allergy update or removal and/or switch to a Β-lactam antibiotic (Figure). If eligible for modification, the interviewing pharmacist made the necessary changes. A templated process note with patient-specific recommendations was entered into the Computerized Patient Record System (CPRS) and the primary care team attending physician was added as an additional signer to be alerted in the system note (eAppendix 2).

This single-center, retrospective cohort study involved review of CPRS notes and clinical interviews in the interviewed group. Hospitalized patients at the RRVAMC aged ≥ 18 years with a documented penicillin allergy or ADR were included. The historical control group consisted of patients admitted between October 31, 2019, and October 31, 2022, and the intervention group consisted of patients admitted between November 1, 2022, and March 1, 2023. Patients in the historical control group were matched 1:1 to the intervention group for penicillin allergy severity (allergy [IgE-mediated], unknown, adverse effect, severe cutaneous or other non–IgE-mediated reaction) and whether they received a noncarbapenem non–Β-lactam antibiotic.

The primary outcome was the number of patient allergies/ADRs removed or changed on patient profiles regardless of whether their antibiotic regimen was changed. This outcome was further assessed by evaluating the number of patient allergies or ADRs removed or changed on patient profiles with or without a change in antibiotic regimen. Primary outcomes were analyzed using χ² and/ or Fisher exact tests, as appropriate to determine statistically significant differences between the interviewed group and the historical control.

Results

Seventy patients were included: 35 patients in the interviewed group and 35 patients in the historical control group, respectively. Both groups had a mean age of 72 years and predominantly included White male patients (Table 1). Following the interview, the allergy profile was modified for 6 patients (17%) in the interview group vs 0 patients in the control group (P = .03) (Table 2). The primary outcome was analyzed separately regardless of an antibiotic regimen change. There was not a statistically significant difference between groups when assessing patients for change in therapy (P > .99). All 6 patients with an allergy profile modification had no change in antibiotic regimen.

Discussion

This study suggests the ABLE process may be a valuable tool for adjusting penicillin allergies or ADRs within patient EHRs. In the interview group, allergies were modified in 6 (17%) patients while no patients in the control group had allergy modifications. Of the 6 allergy profile modifications, 4 allergy labels were changed from an allergy to an ADR. These patients were cleared to receive future Β-lactam antibiotics after clinicians recognized the lack of a true IgE-mediated allergic reaction. In addition, 2 of the modified allergy profiles removed the allergy designation. Although this represents a small subset of interviewed patients, it illustrates the clinical effectiveness of an interview process alone to remove penicillin allergy designations.

Previous research has assessed the impact of pharmacist intervention on penicillin allergy clarification. Mitchell et al implemented a pharmacist-driven Β-lactam allergy assessment and penicillin allergy clinic (PAC) at the MVAMC with the goal of evaluating its impact on allergy clearance. In their study, clinical pharmacy specialists evaluated patients with Β-lactam allergies, and those deemed eligible were later seen in the PAC. Among the 246 patients evaluated using the Β-lactam allergy assessment alone and who were not seen in the PAC, 25% had their penicillin allergy removed following a detailed assessment.⁶

Song et al evaluated the effectiveness and feasibility of a pharmacist-driven penicillin allergy delabeling pilot program without skin testing or oral challenges. Patients with penicillin allergies were interviewed by a pharmacy resident using a standardized checklist. Among the 66 patients interviewed, 12 (18%) met the criteria for delabeling and consented to removal of their allergy.⁷ The delabeling rates in these 2 studies are similar to the 17% rate of allergy modification in our study, although this study is the only one to compare results to a historical control group.

Harper et al evaluated the impact of a penicillin allergy assessment, including penicillin skin testing and oral amoxicillin challenges, on delabeling penicillin allergies. Pharmacists completed a penicillin allergy assessment and performed penicillin skin testing and/or oral amoxicillin challenges for eligible patients. Of 35 patients, 31 (89%) had their penicillin allergies delabeled in the EHR.⁸ The rate of penicillin allergy delabeling in Harper et al was likely higher than that seen in our study due to the use of oral challenge and skin testing. Regardless, a detailed penicillin allergy interview alone was effective at RRVAMC, resulting in a significant rate of allergy removal or change. This supports the use of detailed penicillin allergy assessments in settings where penicillin skin testing or oral challenges may not be feasible.

Mann et al demonstrated the effectiveness of penicillin allergy assessments in switching eligible patients to Β-lactam antibiotics. Their single-center, prospective study assessed the impact of a pharmacist-driven detailed penicillin allergy interview initiative. Interviews that evaluated potential changes to allergy profiles were conducted with 175 patients. Of these patients, 135 (77.1%) were on antimicrobial therapy and 42 (31.1%) patients receiving therapy met criteria to switch to a noncarbapenem Β-lactam antibiotic. Thirty-one patients (73.8%) switched with no signs or symptoms of intolerance demonstrating that an interview can be a valuable tool for antibiotic optimization, specifically in patients with penicillin allergy.⁹ No patients in our study switched antibiotic therapy, likely because only a small number of patients were eligible for transition to a noncarbapenem Β-lactam antibiotic. In the Mann et al study, non–Β-lactam antibiotics, such as fluoroquinolones and carbapenems, accounted for > 75% of the antibiotics used.

Limitations

The sample size of this study was small and its duration was short. There is a risk for selection bias as not all identified patients were able to be interviewed while admitted, but patients on antibiotics were prioritized as they were most likely to directly benefit during their current admission from a modification of their allergy. Most patients in the study were White and male, which may limit the generalizability of the results. Additionally, recommendations regarding antibiotic changes were primarily communicated to the treatment team based on a templated note in CPRS alone. Therefore, implementation of these recommendations largely relied upon nonverbal communication. Direct pharmacist-physician communication could have led to a larger impact on antimicrobial therapy changes. The interviewer’s participation in daily rounds with time allotted to discuss this topic can be considered in the future to improve these processes.

Conclusions

This study found that the ABLE process identified patients for penicillin allergy delabeling. With the high prevalence of inaccurate penicillin allergy documentation, this tool offers VA health care systems a way to empower pharmacists in allergy clarification, leading to improvements in antibiotic stewardship. Although the sample size was small, the ABLE process may provide a framework for VA clinicians. Future research has the potential to demonstrate the practicality and effectiveness this pharmacist-led penicillin allergy interview process can offer clinicians.

Given its safety profile and bactericidal activity against the predominant organisms causing surgical site infections (SSIs), cefazolin remains the most popular choice for surgical prophylaxis.¹ Cefazolin offers protection against the pathogens most likely to contaminate the surgical site while minimizing inappropriate methicillin- resistant Staphylococcus aureus coverage that occurs with alternatives such as vancomycin and clindamycin. Documented allergies to Β-lactam antibiotics have historically forced clinicians to avoid the use of cephalosporins due to the potential risk of cross-reactivity. True type 1 (immunoglobin E [IgE]-mediated) cross-allergic reactions between penicillin and cephalosporins are rare, and previously reported data indicate cross-reactivity as a result of antibody recognition is more closely related to the side-chain identity rather than the Β-lactam ring.^2,3

About 10% of US patients report having a penicillin allergy; however, < 1% of the population has a true IgE-mediated allergic reaction.⁴ Previous research that has challenged penicillin allergies with cefazolin for surgical prophylaxis has reported minimal rates of allergic reactions.^2-5

In previous trials, patients with a history of delayed skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), were excluded. Additionally, patients with an allergy to cefazolin including those with urticaria, angioedema, bronchospasm, or anaphylaxis, were excluded from perioperative retrial of cefazolin. Grant et al found that cefazolin can be safely given to patients with IgE-mediated reactions to penicillin and other cephalosporins due to a structurally different side chain.³

In January 2023, the Veteran Health Indiana (VHI) pharmacy team in conjunction with surgery, infectious disease, and anesthesiology, implemented a screening tool as an amendment to perioperative antibiotic guidance to help determine which patients with a documented penicillin allergy could be candidates for perioperative cefazolin. The implemented screening tool (Allergy Clarification for Cefazolin Evidence-Based Prescribing Tool) has been described by Lam et al, who reported that an increased proportion of patients with documented penicillin allergy received cefazolin without more adverse drug reactions (ADRs).⁵ Patients with a Β-lactam allergy were eligible to receive cefazolin unless the ADR was SJS, TEN, or DRESS, or the offending agent was cefazolin and the patient experienced urticaria, angioedema, bronchospasm, or anaphylaxis. If the reaction was not from cefazolin or was unknown, patients were eligible to receive cefazolin (Figure).

To date, minimal data exist to evaluate the incidence of ADRs when cefazolin is given perioperatively to patients with a previously documented penicillin allergy. The purpose of this study was to evaluate the incidence of allergic ADRs in patients who had a documented penicillin allergy and received periprocedural antibiotics.

Methods

This single-center, retrospective chart review used the US Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) to identify patients with a documented penicillin allergy who underwent an operation and received periprocedural antibiotics between February 1, 2023, and January 31, 2024. This study was reviewed and approved by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

Patients were enrolled if they were aged ≥ 18 years, had a documented penicillin allergy, underwent a surgical intervention, and received perioperative antibiotics during the study period. Patients were excluded if they had a documented penicillin allergy resulting in severe delayed skin reactions (ie, SJS, TEN, or DRESS). These criteria produced 197 surgical procedures. Data were collected for each surgical procedure, so patients could be included more than once. Patient history of allergic reaction to penicillin was obtained through CPRS.

The primary endpoint was the percentage of allergic ADRs in patients with penicillin allergies receiving cefazolin perioperatively. Secondary outcomes included the appropriateness of the antibiotic regimen in congruence with American System of Health Pharmacists (ASHP) recommendations, incidence of SSIs within 30 days of the procedure, incidence of ADRs in those with a history of anaphylaxis vs nonanaphylaxis allergy, incidence of allergic reaction requiring pharmacologic and nonpharmacologic interventions, and incidence of acute kidney injury (AKI). AKI was defined as an increase in serum creatinine by ≥ 0.3 mg/dL within 48 hours or an increase in serum creatinine to ≥ 1.5 times baseline.

Demographic data included sex, age, race, preoperative serum creatinine, and postoperative serum creatinine. Anaphylaxis was defined as an acute onset of illness (within minutes to several hours) with involvement of skin, mucosal tissue, or both involving either respiratory compromise or reduced blood pressures. Allergic reactions were defined as facial, tongue, throat, airway, lip, mouth, periorbital, or eye swelling, urticaria, angioedema, dyspnea, anaphylaxis, or a positive penicillin skin test. Additionally, data collected included the description and severity of postprophylactic antibiotic reaction, antibiotic choice, interventions required for the allergic reaction, SSI occurrence, date of SSI, operating specialty, and postoperative change in renal function.

Descriptive statistics, including mean, SD, and percentages were reported for baseline characteristics of the study population. Percentages were used to demonstrate the differences in primary and secondary outcomes for each study group. Fisher exact tests were used for incidence of ADRs in patients with penicillin allergy who received cefazolin and reported incidence of SSIs.

Results

A total of 197 surgical procedures in patients with a documented penicillin allergy were included; 127 procedures used cefazolin perioperatively, 3 procedures used cefazolin plus gentamicin, and 67 procedures used other antibiotics. Most patients were White (n = 160; 81.2%), male (n = 158; 80.2%), and had a mean age of 64.9 years. Urology was the most common surgical specialty (n = 59; 29.9%) (Table 1). Of the 16 patients with documented penicillin anaphylaxis reaction, 8 received cefazolin and 8 received a different antibiotic. A total of 181 patients reported a nonanaphylaxis allergy. One hundred fifty-one patients (68.6%) reported a reaction history of hives, rash, or swelling (Table 2). Patients could report ≥ 1 reaction. The most prevalent antibiotics used were cefazolin, which was used by 130 patients (61.3%), and clindamycin which was used by 33 patients (15.6%) (Table 3). Patients could receive ≥ 1 antibiotic.

For the primary outcome, the incidence of allergic reactions in patients allergic to penicillin, there was no incidence of allergic reactions in either the cefazolin or other group. Given the absence of reactions, no interventions were required.

There were no ADRs in those with history of anaphylaxis or nonanaphylaxis allergy. In the cefazolin group, 126 of 127 surgical procedure regimens (99.2%) were congruent with ASHP recommendations, all 3 surgical procedures regimens in the cefazolin plus gentamicin group were congruent with ASHP recommendations, and 58 of 67 surgical procedure regimens (86.6%) in the other antibiotic group were congruent with ASHP recommendations. None of the 127 patients in the cefazolin group or of the 3 patients in the cefazolin plus gentamicin group reported an SSI, and 3 of 67 patients (4.5%) had an SSI in the other antibiotic group. One procedure that resulted in SSI was not congruent with ASHP recommendations. Twenty-four patients had 2 serum creatinine levels drawn within 48 hours of surgery. One of 12 patients (8.3%) and 0 of 12 patients had an AKI in the cefazolin and other antibiotic group, respectively (Table 4).

Discussion

Implementation of a screening tool at VHI allowed patients with documented penicillin allergy, including anaphylaxis, to receive cefazolin perioperatively. Broad spectrum antibiotics such as vancomycin, clindamycin, and fluoroquinolones are frequently used in patients allergic to penicillin, which can increase health care costs, risk of toxicity, and antimicrobial resistance.⁴ There was no incidence of allergic reactions noted in patients allergic to penicillin who received cefazolin. When comparing the incidence of observed allergic reactions to received perioperative antibiotics in the cefazolin group to previously published literature, no difference in allergy rates (P = .09) was found.³ Most antibiotics administered were congruent with ASHP guideline recommendations, and most patients eligible for cefazolin received it perioperatively.

Similar to this study, Goodman et al concluded that cefazolin appears to be a safe regimen in patients with documented penicillin anaphylactic reaction for surgical prophylaxis with only 1 (0.2%) potential allergic reaction.⁶ Patients who received cefazolin perioperatively had a statistically significant decrease in SSI rates. There were no clinically or statistically significant differences found between the proportion of allergic reactions or ADRs when compared to alternative antibiotics. Lessard et al concluded that a pharmacist-led interdisciplinary collaborative practice agreement increased cefazolin use in patients allergic to penicillin, including those with urticaria and anaphylaxis, with no reported ADRs.⁷ This study further demonstrated the safety of cefazolin use in patients with anaphylaxis to penicillin.

Limitations

This study’s single-center, retrospective design, patient population, and small sample size limit the generalizability of its results. The data collected are dependent on documentation in the chart. No ADRs were reported from the antibiotics patients received perioperatively. When considering safety data, information such as serum creatinine were available only in CPRS and some patients did not receive a postprocedure serum creatinine level. Additionally, this study did not investigate whether there was an increase in preferred preoperative antimicrobial prophylaxis after implementation of this protocol.

Conclusions

The results of this study support the use of cefazolin perioperatively in patients allergic to penicillin, including those with a history of anaphylaxis. Additional research should be conducted to validate data given the low incidence of ADRs. The primary outcome did not reach statistical significance, but the results may be clinically significant from a stewardship and safety perspective. VHI continues to use the screening tool described in this article.

Given its safety profile and bactericidal activity against the predominant organisms causing surgical site infections (SSIs), cefazolin remains the most popular choice for surgical prophylaxis.¹ Cefazolin offers protection against the pathogens most likely to contaminate the surgical site while minimizing inappropriate methicillin- resistant Staphylococcus aureus coverage that occurs with alternatives such as vancomycin and clindamycin. Documented allergies to Β-lactam antibiotics have historically forced clinicians to avoid the use of cephalosporins due to the potential risk of cross-reactivity. True type 1 (immunoglobin E [IgE]-mediated) cross-allergic reactions between penicillin and cephalosporins are rare, and previously reported data indicate cross-reactivity as a result of antibody recognition is more closely related to the side-chain identity rather than the Β-lactam ring.^2,3

About 10% of US patients report having a penicillin allergy; however, < 1% of the population has a true IgE-mediated allergic reaction.⁴ Previous research that has challenged penicillin allergies with cefazolin for surgical prophylaxis has reported minimal rates of allergic reactions.^2-5

In previous trials, patients with a history of delayed skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), were excluded. Additionally, patients with an allergy to cefazolin including those with urticaria, angioedema, bronchospasm, or anaphylaxis, were excluded from perioperative retrial of cefazolin. Grant et al found that cefazolin can be safely given to patients with IgE-mediated reactions to penicillin and other cephalosporins due to a structurally different side chain.³

In January 2023, the Veteran Health Indiana (VHI) pharmacy team in conjunction with surgery, infectious disease, and anesthesiology, implemented a screening tool as an amendment to perioperative antibiotic guidance to help determine which patients with a documented penicillin allergy could be candidates for perioperative cefazolin. The implemented screening tool (Allergy Clarification for Cefazolin Evidence-Based Prescribing Tool) has been described by Lam et al, who reported that an increased proportion of patients with documented penicillin allergy received cefazolin without more adverse drug reactions (ADRs).⁵ Patients with a Β-lactam allergy were eligible to receive cefazolin unless the ADR was SJS, TEN, or DRESS, or the offending agent was cefazolin and the patient experienced urticaria, angioedema, bronchospasm, or anaphylaxis. If the reaction was not from cefazolin or was unknown, patients were eligible to receive cefazolin (Figure).

To date, minimal data exist to evaluate the incidence of ADRs when cefazolin is given perioperatively to patients with a previously documented penicillin allergy. The purpose of this study was to evaluate the incidence of allergic ADRs in patients who had a documented penicillin allergy and received periprocedural antibiotics.

Methods

This single-center, retrospective chart review used the US Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) to identify patients with a documented penicillin allergy who underwent an operation and received periprocedural antibiotics between February 1, 2023, and January 31, 2024. This study was reviewed and approved by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

Patients were enrolled if they were aged ≥ 18 years, had a documented penicillin allergy, underwent a surgical intervention, and received perioperative antibiotics during the study period. Patients were excluded if they had a documented penicillin allergy resulting in severe delayed skin reactions (ie, SJS, TEN, or DRESS). These criteria produced 197 surgical procedures. Data were collected for each surgical procedure, so patients could be included more than once. Patient history of allergic reaction to penicillin was obtained through CPRS.

The primary endpoint was the percentage of allergic ADRs in patients with penicillin allergies receiving cefazolin perioperatively. Secondary outcomes included the appropriateness of the antibiotic regimen in congruence with American System of Health Pharmacists (ASHP) recommendations, incidence of SSIs within 30 days of the procedure, incidence of ADRs in those with a history of anaphylaxis vs nonanaphylaxis allergy, incidence of allergic reaction requiring pharmacologic and nonpharmacologic interventions, and incidence of acute kidney injury (AKI). AKI was defined as an increase in serum creatinine by ≥ 0.3 mg/dL within 48 hours or an increase in serum creatinine to ≥ 1.5 times baseline.

Demographic data included sex, age, race, preoperative serum creatinine, and postoperative serum creatinine. Anaphylaxis was defined as an acute onset of illness (within minutes to several hours) with involvement of skin, mucosal tissue, or both involving either respiratory compromise or reduced blood pressures. Allergic reactions were defined as facial, tongue, throat, airway, lip, mouth, periorbital, or eye swelling, urticaria, angioedema, dyspnea, anaphylaxis, or a positive penicillin skin test. Additionally, data collected included the description and severity of postprophylactic antibiotic reaction, antibiotic choice, interventions required for the allergic reaction, SSI occurrence, date of SSI, operating specialty, and postoperative change in renal function.

Descriptive statistics, including mean, SD, and percentages were reported for baseline characteristics of the study population. Percentages were used to demonstrate the differences in primary and secondary outcomes for each study group. Fisher exact tests were used for incidence of ADRs in patients with penicillin allergy who received cefazolin and reported incidence of SSIs.

Results

A total of 197 surgical procedures in patients with a documented penicillin allergy were included; 127 procedures used cefazolin perioperatively, 3 procedures used cefazolin plus gentamicin, and 67 procedures used other antibiotics. Most patients were White (n = 160; 81.2%), male (n = 158; 80.2%), and had a mean age of 64.9 years. Urology was the most common surgical specialty (n = 59; 29.9%) (Table 1). Of the 16 patients with documented penicillin anaphylaxis reaction, 8 received cefazolin and 8 received a different antibiotic. A total of 181 patients reported a nonanaphylaxis allergy. One hundred fifty-one patients (68.6%) reported a reaction history of hives, rash, or swelling (Table 2). Patients could report ≥ 1 reaction. The most prevalent antibiotics used were cefazolin, which was used by 130 patients (61.3%), and clindamycin which was used by 33 patients (15.6%) (Table 3). Patients could receive ≥ 1 antibiotic.

For the primary outcome, the incidence of allergic reactions in patients allergic to penicillin, there was no incidence of allergic reactions in either the cefazolin or other group. Given the absence of reactions, no interventions were required.

There were no ADRs in those with history of anaphylaxis or nonanaphylaxis allergy. In the cefazolin group, 126 of 127 surgical procedure regimens (99.2%) were congruent with ASHP recommendations, all 3 surgical procedures regimens in the cefazolin plus gentamicin group were congruent with ASHP recommendations, and 58 of 67 surgical procedure regimens (86.6%) in the other antibiotic group were congruent with ASHP recommendations. None of the 127 patients in the cefazolin group or of the 3 patients in the cefazolin plus gentamicin group reported an SSI, and 3 of 67 patients (4.5%) had an SSI in the other antibiotic group. One procedure that resulted in SSI was not congruent with ASHP recommendations. Twenty-four patients had 2 serum creatinine levels drawn within 48 hours of surgery. One of 12 patients (8.3%) and 0 of 12 patients had an AKI in the cefazolin and other antibiotic group, respectively (Table 4).

Discussion

Implementation of a screening tool at VHI allowed patients with documented penicillin allergy, including anaphylaxis, to receive cefazolin perioperatively. Broad spectrum antibiotics such as vancomycin, clindamycin, and fluoroquinolones are frequently used in patients allergic to penicillin, which can increase health care costs, risk of toxicity, and antimicrobial resistance.⁴ There was no incidence of allergic reactions noted in patients allergic to penicillin who received cefazolin. When comparing the incidence of observed allergic reactions to received perioperative antibiotics in the cefazolin group to previously published literature, no difference in allergy rates (P = .09) was found.³ Most antibiotics administered were congruent with ASHP guideline recommendations, and most patients eligible for cefazolin received it perioperatively.

Similar to this study, Goodman et al concluded that cefazolin appears to be a safe regimen in patients with documented penicillin anaphylactic reaction for surgical prophylaxis with only 1 (0.2%) potential allergic reaction.⁶ Patients who received cefazolin perioperatively had a statistically significant decrease in SSI rates. There were no clinically or statistically significant differences found between the proportion of allergic reactions or ADRs when compared to alternative antibiotics. Lessard et al concluded that a pharmacist-led interdisciplinary collaborative practice agreement increased cefazolin use in patients allergic to penicillin, including those with urticaria and anaphylaxis, with no reported ADRs.⁷ This study further demonstrated the safety of cefazolin use in patients with anaphylaxis to penicillin.

Limitations

This study’s single-center, retrospective design, patient population, and small sample size limit the generalizability of its results. The data collected are dependent on documentation in the chart. No ADRs were reported from the antibiotics patients received perioperatively. When considering safety data, information such as serum creatinine were available only in CPRS and some patients did not receive a postprocedure serum creatinine level. Additionally, this study did not investigate whether there was an increase in preferred preoperative antimicrobial prophylaxis after implementation of this protocol.

Conclusions

The results of this study support the use of cefazolin perioperatively in patients allergic to penicillin, including those with a history of anaphylaxis. Additional research should be conducted to validate data given the low incidence of ADRs. The primary outcome did not reach statistical significance, but the results may be clinically significant from a stewardship and safety perspective. VHI continues to use the screening tool described in this article.

Given its safety profile and bactericidal activity against the predominant organisms causing surgical site infections (SSIs), cefazolin remains the most popular choice for surgical prophylaxis.¹ Cefazolin offers protection against the pathogens most likely to contaminate the surgical site while minimizing inappropriate methicillin- resistant Staphylococcus aureus coverage that occurs with alternatives such as vancomycin and clindamycin. Documented allergies to Β-lactam antibiotics have historically forced clinicians to avoid the use of cephalosporins due to the potential risk of cross-reactivity. True type 1 (immunoglobin E [IgE]-mediated) cross-allergic reactions between penicillin and cephalosporins are rare, and previously reported data indicate cross-reactivity as a result of antibody recognition is more closely related to the side-chain identity rather than the Β-lactam ring.^2,3

About 10% of US patients report having a penicillin allergy; however, < 1% of the population has a true IgE-mediated allergic reaction.⁴ Previous research that has challenged penicillin allergies with cefazolin for surgical prophylaxis has reported minimal rates of allergic reactions.^2-5

In previous trials, patients with a history of delayed skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), were excluded. Additionally, patients with an allergy to cefazolin including those with urticaria, angioedema, bronchospasm, or anaphylaxis, were excluded from perioperative retrial of cefazolin. Grant et al found that cefazolin can be safely given to patients with IgE-mediated reactions to penicillin and other cephalosporins due to a structurally different side chain.³

In January 2023, the Veteran Health Indiana (VHI) pharmacy team in conjunction with surgery, infectious disease, and anesthesiology, implemented a screening tool as an amendment to perioperative antibiotic guidance to help determine which patients with a documented penicillin allergy could be candidates for perioperative cefazolin. The implemented screening tool (Allergy Clarification for Cefazolin Evidence-Based Prescribing Tool) has been described by Lam et al, who reported that an increased proportion of patients with documented penicillin allergy received cefazolin without more adverse drug reactions (ADRs).⁵ Patients with a Β-lactam allergy were eligible to receive cefazolin unless the ADR was SJS, TEN, or DRESS, or the offending agent was cefazolin and the patient experienced urticaria, angioedema, bronchospasm, or anaphylaxis. If the reaction was not from cefazolin or was unknown, patients were eligible to receive cefazolin (Figure).

To date, minimal data exist to evaluate the incidence of ADRs when cefazolin is given perioperatively to patients with a previously documented penicillin allergy. The purpose of this study was to evaluate the incidence of allergic ADRs in patients who had a documented penicillin allergy and received periprocedural antibiotics.

Methods

This single-center, retrospective chart review used the US Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) to identify patients with a documented penicillin allergy who underwent an operation and received periprocedural antibiotics between February 1, 2023, and January 31, 2024. This study was reviewed and approved by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

Patients were enrolled if they were aged ≥ 18 years, had a documented penicillin allergy, underwent a surgical intervention, and received perioperative antibiotics during the study period. Patients were excluded if they had a documented penicillin allergy resulting in severe delayed skin reactions (ie, SJS, TEN, or DRESS). These criteria produced 197 surgical procedures. Data were collected for each surgical procedure, so patients could be included more than once. Patient history of allergic reaction to penicillin was obtained through CPRS.

The primary endpoint was the percentage of allergic ADRs in patients with penicillin allergies receiving cefazolin perioperatively. Secondary outcomes included the appropriateness of the antibiotic regimen in congruence with American System of Health Pharmacists (ASHP) recommendations, incidence of SSIs within 30 days of the procedure, incidence of ADRs in those with a history of anaphylaxis vs nonanaphylaxis allergy, incidence of allergic reaction requiring pharmacologic and nonpharmacologic interventions, and incidence of acute kidney injury (AKI). AKI was defined as an increase in serum creatinine by ≥ 0.3 mg/dL within 48 hours or an increase in serum creatinine to ≥ 1.5 times baseline.

Demographic data included sex, age, race, preoperative serum creatinine, and postoperative serum creatinine. Anaphylaxis was defined as an acute onset of illness (within minutes to several hours) with involvement of skin, mucosal tissue, or both involving either respiratory compromise or reduced blood pressures. Allergic reactions were defined as facial, tongue, throat, airway, lip, mouth, periorbital, or eye swelling, urticaria, angioedema, dyspnea, anaphylaxis, or a positive penicillin skin test. Additionally, data collected included the description and severity of postprophylactic antibiotic reaction, antibiotic choice, interventions required for the allergic reaction, SSI occurrence, date of SSI, operating specialty, and postoperative change in renal function.

Descriptive statistics, including mean, SD, and percentages were reported for baseline characteristics of the study population. Percentages were used to demonstrate the differences in primary and secondary outcomes for each study group. Fisher exact tests were used for incidence of ADRs in patients with penicillin allergy who received cefazolin and reported incidence of SSIs.

Results

A total of 197 surgical procedures in patients with a documented penicillin allergy were included; 127 procedures used cefazolin perioperatively, 3 procedures used cefazolin plus gentamicin, and 67 procedures used other antibiotics. Most patients were White (n = 160; 81.2%), male (n = 158; 80.2%), and had a mean age of 64.9 years. Urology was the most common surgical specialty (n = 59; 29.9%) (Table 1). Of the 16 patients with documented penicillin anaphylaxis reaction, 8 received cefazolin and 8 received a different antibiotic. A total of 181 patients reported a nonanaphylaxis allergy. One hundred fifty-one patients (68.6%) reported a reaction history of hives, rash, or swelling (Table 2). Patients could report ≥ 1 reaction. The most prevalent antibiotics used were cefazolin, which was used by 130 patients (61.3%), and clindamycin which was used by 33 patients (15.6%) (Table 3). Patients could receive ≥ 1 antibiotic.

For the primary outcome, the incidence of allergic reactions in patients allergic to penicillin, there was no incidence of allergic reactions in either the cefazolin or other group. Given the absence of reactions, no interventions were required.

There were no ADRs in those with history of anaphylaxis or nonanaphylaxis allergy. In the cefazolin group, 126 of 127 surgical procedure regimens (99.2%) were congruent with ASHP recommendations, all 3 surgical procedures regimens in the cefazolin plus gentamicin group were congruent with ASHP recommendations, and 58 of 67 surgical procedure regimens (86.6%) in the other antibiotic group were congruent with ASHP recommendations. None of the 127 patients in the cefazolin group or of the 3 patients in the cefazolin plus gentamicin group reported an SSI, and 3 of 67 patients (4.5%) had an SSI in the other antibiotic group. One procedure that resulted in SSI was not congruent with ASHP recommendations. Twenty-four patients had 2 serum creatinine levels drawn within 48 hours of surgery. One of 12 patients (8.3%) and 0 of 12 patients had an AKI in the cefazolin and other antibiotic group, respectively (Table 4).

Discussion

Implementation of a screening tool at VHI allowed patients with documented penicillin allergy, including anaphylaxis, to receive cefazolin perioperatively. Broad spectrum antibiotics such as vancomycin, clindamycin, and fluoroquinolones are frequently used in patients allergic to penicillin, which can increase health care costs, risk of toxicity, and antimicrobial resistance.⁴ There was no incidence of allergic reactions noted in patients allergic to penicillin who received cefazolin. When comparing the incidence of observed allergic reactions to received perioperative antibiotics in the cefazolin group to previously published literature, no difference in allergy rates (P = .09) was found.³ Most antibiotics administered were congruent with ASHP guideline recommendations, and most patients eligible for cefazolin received it perioperatively.

Similar to this study, Goodman et al concluded that cefazolin appears to be a safe regimen in patients with documented penicillin anaphylactic reaction for surgical prophylaxis with only 1 (0.2%) potential allergic reaction.⁶ Patients who received cefazolin perioperatively had a statistically significant decrease in SSI rates. There were no clinically or statistically significant differences found between the proportion of allergic reactions or ADRs when compared to alternative antibiotics. Lessard et al concluded that a pharmacist-led interdisciplinary collaborative practice agreement increased cefazolin use in patients allergic to penicillin, including those with urticaria and anaphylaxis, with no reported ADRs.⁷ This study further demonstrated the safety of cefazolin use in patients with anaphylaxis to penicillin.

Limitations

This study’s single-center, retrospective design, patient population, and small sample size limit the generalizability of its results. The data collected are dependent on documentation in the chart. No ADRs were reported from the antibiotics patients received perioperatively. When considering safety data, information such as serum creatinine were available only in CPRS and some patients did not receive a postprocedure serum creatinine level. Additionally, this study did not investigate whether there was an increase in preferred preoperative antimicrobial prophylaxis after implementation of this protocol.

Conclusions

The results of this study support the use of cefazolin perioperatively in patients allergic to penicillin, including those with a history of anaphylaxis. Additional research should be conducted to validate data given the low incidence of ADRs. The primary outcome did not reach statistical significance, but the results may be clinically significant from a stewardship and safety perspective. VHI continues to use the screening tool described in this article.

For there was never yet philosopher that could endure the toothache patiently

Much Ado About Nothing by William Shakespeare

Almost anyone who has worked for a long time in a US Department of Veterans Affairs (VA) clinic or hospital has had patients in dire need of dental services who could neither access nor pay for them. I have seen dental problems ranging from older veterans who were nearly edentulous and needed expensive dentures or implants to younger veterans who never had regular dental care and needed a periodontist to save their teeth, to individuals with terrible toothaches that antibiotics could not cure. As Shakespeare quips in Much Ado About Nothing, almost nothing is worse than a toothache.

Many VA primary care practitioners and social workers kept lists of local sliding-scale dentists or arranged for veterans to visit dental and hygiene school clinics for reduced fees. Even when VA dentists were not permitted to see a veteran, many would assist in finding them affordable care in the community. However, that was never enough to meet the oral health needs of veterans. One of the most common complaints of patients who otherwise were pleased with their VA health care was that it did not cover dental services.¹

Most veterans qualify for health care and other VA benefits. Dental care is an exception, with only about a quarter (26%) of the > 9 million veterans active in the Veterans Health Administration (VHA) eligible for care. Even under this restricted eligibility, about 888,000 veterans have received dental services either through the VHA or in the community. In 2025, the VA paid community-based dentists for > 3.5 million procedures for veterans, which underscores the magnitude of the demand.²

Given the gap in dental care, many veterans and their caregivers both personal and professional will likely be encouraged that in February the VA announced plans to improve access to dental care through expanding community care dental services. “Dental health is a critical component of overall well-being,” VA Secretary Doug Collins noted. VA issued a request for proposals (RFP) for a new dental administrator who would oversee the operations of a new network of dental practitioners. The new vendor contract would operationalize general dental services, like tooth extractions, as well as specialized services such as periodontics, dentures, and pharmacy support for dental medications. Most importantly, the new program would cover preventive care to help avoid many of the dental problems veterans now experience. Proposals are due March 16.²

Yet, there is a catch. The community care program will only be available to eligible veterans just like previous dental services both in the VA and the community. I was always somewhat ashamed that despite my working decades at the VHA, I never had a satisfactory answer for veterans who asked me why they were not eligible for dental care. The regulatory response is that eligibility for dental services is a complex determination depending on service-connected military service, and specialized clinical indices. Dental coverage is provided for veterans who have 100% service-connected or total disability, prisoners of war, and veterans whose dental disease exacerbates a comorbid medical condition. Those not eligible for VA dental coverage may still get treatment if they, for example, have a cancer diagnosis and without dental work the chemotherapy treatment would place them at a higher risk of an oral infection. Veterans participating in a rehabilitation program who have poor dentition that prevents them from reaching their rehabilitative goals also may receive VA dental care. In addition, some veterans who are experiencing homelessness and others who did not receive a dental examination prior to discharge from active duty may be eligible for dental benefits.³ VA also offers lower-priced dental insurance for ineligible veterans.⁴

The new RFP does little to expand eligibility of veterans to receive VA dental care, and it is hard to not see the announcement as another step in the privatization of VHA. Medically and ethically, it seems to perpetuate a double standard between physical and oral health that makes no scientific sense.^5-7 I sometimes joke that in medical school we had maybe 2 days of teaching about teeth and even that limited exposure to dental pathology was sufficient for us to learn that chronic conditions like respiratory disease and lifestyle choices like poor diet cause and contribute to dental problems.

Like so many areas of veteran care, dental health in veterans is worse compared with those who never served, making it harder to justify the exclusion of dental services from veteran health benefits. A study in Military Medicine looked at 11,539 former service members and found a higher prevalence of individuals with tooth decay, missing teeth, tooth fillings, caries, and periodontitis. While military service per se was not associated with the findings, higher rates of hypertension, hyperlipidemia, depression, and diabetes in veterans compared with nonveterans, which are related to serving in uniform, were covariates.⁸

That depression is an indirect factor in dental disease may seem surprising. However, this is more evidence that human health is truly holistic, with mutual interactions between the body (including the teeth) and mind. Oral care needs to be incorporated into the VA whole health approach for all veterans. In a series of articles in Psychiatric News, VA psychiatrist Antoinette Shappell and VA dentist Pierre Cartier identify several links between dental and mental health.^9,10 Veterans with anxiety disorders may fear going to the dentist even when care is needed. Serious mental illness may result in poor diet, and difficulty performing preventive care. Many psychotropic medications may cause xerostomia that worsens tooth decay and veterans with posttraumatic stress disorder may suffer from bruxism. I regularly saw these conditions when I worked in a primary care psychiatry clinic. Being able to coordinate with VA dentists and staff to provide integrated care would have benefited these already burdened veterans.

An estimated $5.4 billion has been spent on 3.6 million veterans who were seen in emergency departments for dental problems. That cost alone should convince policy makers that the deficit in VA dental care needs to be filled with efficacious high-quality comprehensive dental services for as many veterans as possible. And there are signs that is exactly what is happening in Congress. A bill in the House of Representatives proposes to expand dental care benefits to all veterans eligible for other VA health benefits.¹¹ There are also other legislative initiatives in the works.⁴ Together with the VA’s plans for a new community care dental network, that does give veterans and federal practitioners something to smile about.

For there was never yet philosopher that could endure the toothache patiently

Much Ado About Nothing by William Shakespeare

Almost anyone who has worked for a long time in a US Department of Veterans Affairs (VA) clinic or hospital has had patients in dire need of dental services who could neither access nor pay for them. I have seen dental problems ranging from older veterans who were nearly edentulous and needed expensive dentures or implants to younger veterans who never had regular dental care and needed a periodontist to save their teeth, to individuals with terrible toothaches that antibiotics could not cure. As Shakespeare quips in Much Ado About Nothing, almost nothing is worse than a toothache.

Many VA primary care practitioners and social workers kept lists of local sliding-scale dentists or arranged for veterans to visit dental and hygiene school clinics for reduced fees. Even when VA dentists were not permitted to see a veteran, many would assist in finding them affordable care in the community. However, that was never enough to meet the oral health needs of veterans. One of the most common complaints of patients who otherwise were pleased with their VA health care was that it did not cover dental services.¹

Most veterans qualify for health care and other VA benefits. Dental care is an exception, with only about a quarter (26%) of the > 9 million veterans active in the Veterans Health Administration (VHA) eligible for care. Even under this restricted eligibility, about 888,000 veterans have received dental services either through the VHA or in the community. In 2025, the VA paid community-based dentists for > 3.5 million procedures for veterans, which underscores the magnitude of the demand.²

Given the gap in dental care, many veterans and their caregivers both personal and professional will likely be encouraged that in February the VA announced plans to improve access to dental care through expanding community care dental services. “Dental health is a critical component of overall well-being,” VA Secretary Doug Collins noted. VA issued a request for proposals (RFP) for a new dental administrator who would oversee the operations of a new network of dental practitioners. The new vendor contract would operationalize general dental services, like tooth extractions, as well as specialized services such as periodontics, dentures, and pharmacy support for dental medications. Most importantly, the new program would cover preventive care to help avoid many of the dental problems veterans now experience. Proposals are due March 16.²

Yet, there is a catch. The community care program will only be available to eligible veterans just like previous dental services both in the VA and the community. I was always somewhat ashamed that despite my working decades at the VHA, I never had a satisfactory answer for veterans who asked me why they were not eligible for dental care. The regulatory response is that eligibility for dental services is a complex determination depending on service-connected military service, and specialized clinical indices. Dental coverage is provided for veterans who have 100% service-connected or total disability, prisoners of war, and veterans whose dental disease exacerbates a comorbid medical condition. Those not eligible for VA dental coverage may still get treatment if they, for example, have a cancer diagnosis and without dental work the chemotherapy treatment would place them at a higher risk of an oral infection. Veterans participating in a rehabilitation program who have poor dentition that prevents them from reaching their rehabilitative goals also may receive VA dental care. In addition, some veterans who are experiencing homelessness and others who did not receive a dental examination prior to discharge from active duty may be eligible for dental benefits.³ VA also offers lower-priced dental insurance for ineligible veterans.⁴

The new RFP does little to expand eligibility of veterans to receive VA dental care, and it is hard to not see the announcement as another step in the privatization of VHA. Medically and ethically, it seems to perpetuate a double standard between physical and oral health that makes no scientific sense.^5-7 I sometimes joke that in medical school we had maybe 2 days of teaching about teeth and even that limited exposure to dental pathology was sufficient for us to learn that chronic conditions like respiratory disease and lifestyle choices like poor diet cause and contribute to dental problems.

Like so many areas of veteran care, dental health in veterans is worse compared with those who never served, making it harder to justify the exclusion of dental services from veteran health benefits. A study in Military Medicine looked at 11,539 former service members and found a higher prevalence of individuals with tooth decay, missing teeth, tooth fillings, caries, and periodontitis. While military service per se was not associated with the findings, higher rates of hypertension, hyperlipidemia, depression, and diabetes in veterans compared with nonveterans, which are related to serving in uniform, were covariates.⁸

That depression is an indirect factor in dental disease may seem surprising. However, this is more evidence that human health is truly holistic, with mutual interactions between the body (including the teeth) and mind. Oral care needs to be incorporated into the VA whole health approach for all veterans. In a series of articles in Psychiatric News, VA psychiatrist Antoinette Shappell and VA dentist Pierre Cartier identify several links between dental and mental health.^9,10 Veterans with anxiety disorders may fear going to the dentist even when care is needed. Serious mental illness may result in poor diet, and difficulty performing preventive care. Many psychotropic medications may cause xerostomia that worsens tooth decay and veterans with posttraumatic stress disorder may suffer from bruxism. I regularly saw these conditions when I worked in a primary care psychiatry clinic. Being able to coordinate with VA dentists and staff to provide integrated care would have benefited these already burdened veterans.

An estimated $5.4 billion has been spent on 3.6 million veterans who were seen in emergency departments for dental problems. That cost alone should convince policy makers that the deficit in VA dental care needs to be filled with efficacious high-quality comprehensive dental services for as many veterans as possible. And there are signs that is exactly what is happening in Congress. A bill in the House of Representatives proposes to expand dental care benefits to all veterans eligible for other VA health benefits.¹¹ There are also other legislative initiatives in the works.⁴ Together with the VA’s plans for a new community care dental network, that does give veterans and federal practitioners something to smile about.

For there was never yet philosopher that could endure the toothache patiently

Much Ado About Nothing by William Shakespeare

Almost anyone who has worked for a long time in a US Department of Veterans Affairs (VA) clinic or hospital has had patients in dire need of dental services who could neither access nor pay for them. I have seen dental problems ranging from older veterans who were nearly edentulous and needed expensive dentures or implants to younger veterans who never had regular dental care and needed a periodontist to save their teeth, to individuals with terrible toothaches that antibiotics could not cure. As Shakespeare quips in Much Ado About Nothing, almost nothing is worse than a toothache.

Many VA primary care practitioners and social workers kept lists of local sliding-scale dentists or arranged for veterans to visit dental and hygiene school clinics for reduced fees. Even when VA dentists were not permitted to see a veteran, many would assist in finding them affordable care in the community. However, that was never enough to meet the oral health needs of veterans. One of the most common complaints of patients who otherwise were pleased with their VA health care was that it did not cover dental services.¹

Most veterans qualify for health care and other VA benefits. Dental care is an exception, with only about a quarter (26%) of the > 9 million veterans active in the Veterans Health Administration (VHA) eligible for care. Even under this restricted eligibility, about 888,000 veterans have received dental services either through the VHA or in the community. In 2025, the VA paid community-based dentists for > 3.5 million procedures for veterans, which underscores the magnitude of the demand.²

Given the gap in dental care, many veterans and their caregivers both personal and professional will likely be encouraged that in February the VA announced plans to improve access to dental care through expanding community care dental services. “Dental health is a critical component of overall well-being,” VA Secretary Doug Collins noted. VA issued a request for proposals (RFP) for a new dental administrator who would oversee the operations of a new network of dental practitioners. The new vendor contract would operationalize general dental services, like tooth extractions, as well as specialized services such as periodontics, dentures, and pharmacy support for dental medications. Most importantly, the new program would cover preventive care to help avoid many of the dental problems veterans now experience. Proposals are due March 16.²

Yet, there is a catch. The community care program will only be available to eligible veterans just like previous dental services both in the VA and the community. I was always somewhat ashamed that despite my working decades at the VHA, I never had a satisfactory answer for veterans who asked me why they were not eligible for dental care. The regulatory response is that eligibility for dental services is a complex determination depending on service-connected military service, and specialized clinical indices. Dental coverage is provided for veterans who have 100% service-connected or total disability, prisoners of war, and veterans whose dental disease exacerbates a comorbid medical condition. Those not eligible for VA dental coverage may still get treatment if they, for example, have a cancer diagnosis and without dental work the chemotherapy treatment would place them at a higher risk of an oral infection. Veterans participating in a rehabilitation program who have poor dentition that prevents them from reaching their rehabilitative goals also may receive VA dental care. In addition, some veterans who are experiencing homelessness and others who did not receive a dental examination prior to discharge from active duty may be eligible for dental benefits.³ VA also offers lower-priced dental insurance for ineligible veterans.⁴

The new RFP does little to expand eligibility of veterans to receive VA dental care, and it is hard to not see the announcement as another step in the privatization of VHA. Medically and ethically, it seems to perpetuate a double standard between physical and oral health that makes no scientific sense.^5-7 I sometimes joke that in medical school we had maybe 2 days of teaching about teeth and even that limited exposure to dental pathology was sufficient for us to learn that chronic conditions like respiratory disease and lifestyle choices like poor diet cause and contribute to dental problems.

Like so many areas of veteran care, dental health in veterans is worse compared with those who never served, making it harder to justify the exclusion of dental services from veteran health benefits. A study in Military Medicine looked at 11,539 former service members and found a higher prevalence of individuals with tooth decay, missing teeth, tooth fillings, caries, and periodontitis. While military service per se was not associated with the findings, higher rates of hypertension, hyperlipidemia, depression, and diabetes in veterans compared with nonveterans, which are related to serving in uniform, were covariates.⁸

That depression is an indirect factor in dental disease may seem surprising. However, this is more evidence that human health is truly holistic, with mutual interactions between the body (including the teeth) and mind. Oral care needs to be incorporated into the VA whole health approach for all veterans. In a series of articles in Psychiatric News, VA psychiatrist Antoinette Shappell and VA dentist Pierre Cartier identify several links between dental and mental health.^9,10 Veterans with anxiety disorders may fear going to the dentist even when care is needed. Serious mental illness may result in poor diet, and difficulty performing preventive care. Many psychotropic medications may cause xerostomia that worsens tooth decay and veterans with posttraumatic stress disorder may suffer from bruxism. I regularly saw these conditions when I worked in a primary care psychiatry clinic. Being able to coordinate with VA dentists and staff to provide integrated care would have benefited these already burdened veterans.

An estimated $5.4 billion has been spent on 3.6 million veterans who were seen in emergency departments for dental problems. That cost alone should convince policy makers that the deficit in VA dental care needs to be filled with efficacious high-quality comprehensive dental services for as many veterans as possible. And there are signs that is exactly what is happening in Congress. A bill in the House of Representatives proposes to expand dental care benefits to all veterans eligible for other VA health benefits.¹¹ There are also other legislative initiatives in the works.⁴ Together with the VA’s plans for a new community care dental network, that does give veterans and federal practitioners something to smile about.

Roughly 8.6% of the 17.4 million US veterans live in poverty. About 11.1% are considered food insecure (ie, unable to acquire adequate food for ≥1 household members), with another 5.3% considered very food insecure (ie, eating patterns of ≥1 household members were disrupted and their food intake was reduced at least some time during the year). Compared with nonveterans, veterans are 7.4% more likely to be food insecure.¹ This high prevalence of food insecurity and poverty has a negative impact on veteran diets.

Veterans’ diets contained more added sugars and solid fats and scored lower compared with nonveterans when assessed for diet quality with the Healthy Eating Index.² Veterans have a higher prevalence of diet-related chronic disease, including diabetes, hypertension, and obesity compared with the nonveterans.^3-5 Given the critical role of diet in health and disease risk, enhancing diet quality among veterans has garnered significant attention and calls to action.^2,6,7 While there are many factors that contribute to diet, any veteran can receive a consultation or self-refer to receive nutrition counseling effective for improving diet quality, within the US Department of Veterans Affairs (VA).

The NOVA food classification system describes diet quality by categorizing food items by processing methods and ingredients into 4 food groups.⁸ The first is unprocessed and minimally processed items (MPFs) such as fresh fruits, vegetables, and meats. MPFs consist of whole foods which can also be minimally processed (eg, chopping, drying, grinding, heating, chilling). Culinary processed foods (CPFs) are processed foods for cooking (eg, salt, butter, and vinegar) and are typically eaten in small quantities along with MPFs. Processed foods (PRFs) include canned and smoked foods, while ultra-processed foods (UPFs) are distinguished by industrial ingredients, requiring specialized tools and processing techniques, and hyper-palatability related to color, flavor, and packaging.⁸ Examples of UPFs include mass-produced breads found at grocery stores, prepackaged snacks and meals, and hydrogenated oils. UPF consumption is associated with higher risk for negative cardiometabolic outcomes, common mental disorders, and all-cause mortality.⁹ To date, only a study by Powell et al has used the NOVA classification system in a veteran population, and it was limited to a comparison of the price of UPFs and veteran body mass index (BMI).¹⁰ Therefore, it remains unknown what percentage of total energy intake (TEI) comes from UPFs in the diets of veterans.

This study sought to quantify the proportion of TEI from UPFs among a sample of patients from the VA Phoenix Health Care System (VAPHCS). Results from a 2021 global meta-analysis reveal that the US and United Kingdom have the highest intakes of UPFs in the world.¹¹ Specifically, within the US, 15 studies with 234,890 participants reveal that the majority of TEI (about 55%) comes from UPFs.¹¹ We hypothesized that this veteran sample would have a higher proportion of TEI from UPFs, possibly due to a higher prevalence of poverty and food insecurity among veterans compared with nonveterans.¹ If the percentage of TEI coming from UPF is higher or even similar to nonveterans, further efforts to increase veterans’ use of the available nutritional services would be warranted to minimize nutrition-related disease among veterans.

Methods

This is a cross-sectional, secondary data analysis of baseline 3-day food records collected from 2017 to 2020 from 92 patients recruited at VAPHCS to participate in a whole-food plant-based diet study.¹² The original study was reviewed and approved by the VAPHCS Institutional Review Board (1593830). Recruitment methods included clinician recommendation, a recorded advertisement played while phone calls were on hold, and flyers distributed throughout VAPHCS. Patients were included if they were aged 18 to 90 years, had a BMI 25.1 to 39.9, had a diagnosis of nutrition-related chronic disease (hypertension, diabetes, or hyperlipidemia), an interest and desire to make a lifestyle change, active telephone contact information (either landline or cell phone), no contraindication to be on a whole-food plant-based diet, access to transportation and a functioning kitchen, ability to prepare meals independently, access to a computer or tablet with internet access, and a digital camera or smartphone. Exclusion criteria included significant unplanned weight loss within 6 months, uncontrolled insulin-dependent diabetes with a current hemoglobin A_1c > 9%, pregnancy/lactation, taking prescribed weight loss medication, currently following a diet (eg, plant-based diet, vegan, or medical weight loss program diet), celiac disease diagnosed within 6 months, end-stage hepatic disease or renal disease requiring dialysis, active cancer or receiving chemotherapy or radiation therapy, active alcohol or substance use disorder, history of eating disorders, fasting triglyceride level > 350 mg/dL, any psychological issues that prevent adherence, inability to speak English, limited mobility, and homeless or in housing with limited kitchen access. A baseline 3-day food record was collected from the participants and used in this secondary analysis.

Diet Analysis

Food records were analyzed using Esha Research Food Processor 4.0 to identify calorie and macronutrient information. To limit bias, food items were coded independently by 2 researchers into 4 food processing groups determined by the NOVA classification: MPF, CPF, PRF, and UPF.⁸ When possible, specific ingredient information was collected using internet searches for brand product websites. Initial coding had an 89% agreement rate for food item coding between the 2 researchers. As coding was done in duplicate, a third researcher resolved disagreements. The number of food items for each processing group was determined and the mean (SD) percentage of TEI for each NOVA group was provided across participants. A 1-way analysis of variance and Tukey Multiple Comparisons Test were used to determine significance between groups with an α = .05 using Prism V9.

Results

Of the 92 participants in the original study, only 79 met inclusion criteria and had baseline diet data. The 79 veterans had a mean (SD) age of 61 (13) years and 59 (75%) were male (Table 1). Mean (SD) TEI was 1921 (815) kcal. The mean (SD) percentage of calories from carbohydrate, fat, and protein were 46% (21%), 39% (20%), and 16% (6%), respectively (Table 2).

A mean (SD) of 36 (12) food items were analyzed from the 3-day food records. The majority of food items were UPFs (56%), 33% were MPFs, 8% were PRFs, and 3% were CPFs. In total, 75% of TEI came from UPFs (P < .001); only 14% of TEI came from minimally processed foods (Figure).

Discussion

To our knowledge, this is the first analysis of UPF consumption among US veterans. TEIs coming from UPFs appear to be about 20% higher among veterans compared to nonveterans: 75% vs 55%.¹¹ Coupled with high UPF consumption, MPFs (14%) and PRFs (9%) represent smaller sources of TEI among surveyed veterans. Top caloric sources of UPFs in the US include sandwiches (including burgers), sweet bakery products, savory snacks, pizza, sweetened beverages, and breads, rolls, and tortillas, and likely reflect the major sources of UPFs in the veteran diet.¹³ As the statistical comparison between the veteran data and nonveteran data is not feasible in the present study, a future study with a much larger sample size would be needed for a direct comparison.

While the exact cause of higher UPF consumption among sampled veterans remains unknown and likely multifactorial (eg, cost, food insecurity, access, cooking skills, nutrition knowledge), veterans can receive a consult or self-refer to a registered dietitian nutritionist (RDN) for nutrition education. Counseling has been shown to be an effective way to improve diet quality and increase daily fruit and vegetable intake.¹⁴ High consumption of UPFs, which are generally energy-dense and nutrient-poor, contributes to the low diet quality observed in veterans, and future research examining the relationship between UPF intake and overall diet quality among veterans is warranted.^2,15 As nutrition knowledge is associated with higher diet quality among veterans, increased use of nutrition services (ie, nutrition education or food supplement programs) has the potential to influence consumption of MPFs and decrease consumption of UPFs.¹⁶ Subsequently, UPF-targeted interventions developed by VA RDNs hold the promise to decrease consumption of UPFs and increase intake of MPFs and PRFs.

Veterans have a high prevalence of diabetes, hypertension, and obesity.⁹ The high UPF intake observed in this sample of veterans may increase the risk for these chronic diseases and overall mortality. The high percentage of TEI from UPFs among veterans is also of concern not only due to potential negative health outcomes, but also associated costs of treating veterans with multimorbidities.¹⁷ Targeting UPF intake via nutritional education may promote health and decrease the financial burden needed to support the health of veterans.

Improving veteran health and well-being, including enhancing health care accessibility in underserved areas, are pivotal objectives of the VA strategic plan for 2026 to 2030. Public policy aims to tackle food insecurity within the veteran population during the first 5 years of civilian life.¹⁸ In alignment with the White House Strategy on Hunger, Nutrition, and Health, VA established a Food Security Office (FSO) in 2023. The FSO mission is to use an interdisciplinary approach to provide resources to ensure veteran food security and create an environment where all veterans are food and nutrition secure.

Limitations

This study has several limitations. As the Food Processor software database does not include all brand items, similar brands were used to mirror the nutrient profile. While food records are common among veteran diet studies, accuracy may be reduced due to self-reporting bias.¹⁹ Different interpretation of the NOVA classification designation for various food items is possible, however, 89% of foods were coded the same by the research team which suggests high accuracy in food coding. Specific ingredient information was not collected from the 3-day food records; thus, these records were not produced in such a way to improve the accuracy of the NOVA classification designation. This study was limited by its small sample size (N = 79); although, this analysis is larger than other studies of UPF consumption in the US.^20,21 In addition, the generalizability of this study is limited as this population sample was from a single VA hospital and may not reflect the overall veteran population. Participants in this study were recruited only from those receiving VA care, thus their diet quality may not represent the quality consumed by veterans not participating in VA services. Further research on UPF consumption among veterans is warranted with a larger, more representative study sample size.

Conclusions

As this is the highest observed UPF intake documented in the US, these results should be of concern for the VA and its RDNs. More research is needed to better understand why UPF consumption is so high among veterans, what barriers veterans face to decreasing UPF consumption, and what intervention(s) veterans would welcome to improve their diet quality. Presently, veterans are provided with access to a variety of effective nutrition education and counseling options and should be encouraged to use these services. VA RDNs should be aware of the high intake of UPFs in the veteran population and familiarize themselves with education and counseling strategies that promote behavior change to replace UPFs with more nutrient-dense foods choices.

Roughly 8.6% of the 17.4 million US veterans live in poverty. About 11.1% are considered food insecure (ie, unable to acquire adequate food for ≥1 household members), with another 5.3% considered very food insecure (ie, eating patterns of ≥1 household members were disrupted and their food intake was reduced at least some time during the year). Compared with nonveterans, veterans are 7.4% more likely to be food insecure.¹ This high prevalence of food insecurity and poverty has a negative impact on veteran diets.

Veterans’ diets contained more added sugars and solid fats and scored lower compared with nonveterans when assessed for diet quality with the Healthy Eating Index.² Veterans have a higher prevalence of diet-related chronic disease, including diabetes, hypertension, and obesity compared with the nonveterans.^3-5 Given the critical role of diet in health and disease risk, enhancing diet quality among veterans has garnered significant attention and calls to action.^2,6,7 While there are many factors that contribute to diet, any veteran can receive a consultation or self-refer to receive nutrition counseling effective for improving diet quality, within the US Department of Veterans Affairs (VA).

The NOVA food classification system describes diet quality by categorizing food items by processing methods and ingredients into 4 food groups.⁸ The first is unprocessed and minimally processed items (MPFs) such as fresh fruits, vegetables, and meats. MPFs consist of whole foods which can also be minimally processed (eg, chopping, drying, grinding, heating, chilling). Culinary processed foods (CPFs) are processed foods for cooking (eg, salt, butter, and vinegar) and are typically eaten in small quantities along with MPFs. Processed foods (PRFs) include canned and smoked foods, while ultra-processed foods (UPFs) are distinguished by industrial ingredients, requiring specialized tools and processing techniques, and hyper-palatability related to color, flavor, and packaging.⁸ Examples of UPFs include mass-produced breads found at grocery stores, prepackaged snacks and meals, and hydrogenated oils. UPF consumption is associated with higher risk for negative cardiometabolic outcomes, common mental disorders, and all-cause mortality.⁹ To date, only a study by Powell et al has used the NOVA classification system in a veteran population, and it was limited to a comparison of the price of UPFs and veteran body mass index (BMI).¹⁰ Therefore, it remains unknown what percentage of total energy intake (TEI) comes from UPFs in the diets of veterans.

This study sought to quantify the proportion of TEI from UPFs among a sample of patients from the VA Phoenix Health Care System (VAPHCS). Results from a 2021 global meta-analysis reveal that the US and United Kingdom have the highest intakes of UPFs in the world.¹¹ Specifically, within the US, 15 studies with 234,890 participants reveal that the majority of TEI (about 55%) comes from UPFs.¹¹ We hypothesized that this veteran sample would have a higher proportion of TEI from UPFs, possibly due to a higher prevalence of poverty and food insecurity among veterans compared with nonveterans.¹ If the percentage of TEI coming from UPF is higher or even similar to nonveterans, further efforts to increase veterans’ use of the available nutritional services would be warranted to minimize nutrition-related disease among veterans.

Methods

This is a cross-sectional, secondary data analysis of baseline 3-day food records collected from 2017 to 2020 from 92 patients recruited at VAPHCS to participate in a whole-food plant-based diet study.¹² The original study was reviewed and approved by the VAPHCS Institutional Review Board (1593830). Recruitment methods included clinician recommendation, a recorded advertisement played while phone calls were on hold, and flyers distributed throughout VAPHCS. Patients were included if they were aged 18 to 90 years, had a BMI 25.1 to 39.9, had a diagnosis of nutrition-related chronic disease (hypertension, diabetes, or hyperlipidemia), an interest and desire to make a lifestyle change, active telephone contact information (either landline or cell phone), no contraindication to be on a whole-food plant-based diet, access to transportation and a functioning kitchen, ability to prepare meals independently, access to a computer or tablet with internet access, and a digital camera or smartphone. Exclusion criteria included significant unplanned weight loss within 6 months, uncontrolled insulin-dependent diabetes with a current hemoglobin A_1c > 9%, pregnancy/lactation, taking prescribed weight loss medication, currently following a diet (eg, plant-based diet, vegan, or medical weight loss program diet), celiac disease diagnosed within 6 months, end-stage hepatic disease or renal disease requiring dialysis, active cancer or receiving chemotherapy or radiation therapy, active alcohol or substance use disorder, history of eating disorders, fasting triglyceride level > 350 mg/dL, any psychological issues that prevent adherence, inability to speak English, limited mobility, and homeless or in housing with limited kitchen access. A baseline 3-day food record was collected from the participants and used in this secondary analysis.

Diet Analysis

Food records were analyzed using Esha Research Food Processor 4.0 to identify calorie and macronutrient information. To limit bias, food items were coded independently by 2 researchers into 4 food processing groups determined by the NOVA classification: MPF, CPF, PRF, and UPF.⁸ When possible, specific ingredient information was collected using internet searches for brand product websites. Initial coding had an 89% agreement rate for food item coding between the 2 researchers. As coding was done in duplicate, a third researcher resolved disagreements. The number of food items for each processing group was determined and the mean (SD) percentage of TEI for each NOVA group was provided across participants. A 1-way analysis of variance and Tukey Multiple Comparisons Test were used to determine significance between groups with an α = .05 using Prism V9.

Results

Of the 92 participants in the original study, only 79 met inclusion criteria and had baseline diet data. The 79 veterans had a mean (SD) age of 61 (13) years and 59 (75%) were male (Table 1). Mean (SD) TEI was 1921 (815) kcal. The mean (SD) percentage of calories from carbohydrate, fat, and protein were 46% (21%), 39% (20%), and 16% (6%), respectively (Table 2).

A mean (SD) of 36 (12) food items were analyzed from the 3-day food records. The majority of food items were UPFs (56%), 33% were MPFs, 8% were PRFs, and 3% were CPFs. In total, 75% of TEI came from UPFs (P < .001); only 14% of TEI came from minimally processed foods (Figure).

Discussion

To our knowledge, this is the first analysis of UPF consumption among US veterans. TEIs coming from UPFs appear to be about 20% higher among veterans compared to nonveterans: 75% vs 55%.¹¹ Coupled with high UPF consumption, MPFs (14%) and PRFs (9%) represent smaller sources of TEI among surveyed veterans. Top caloric sources of UPFs in the US include sandwiches (including burgers), sweet bakery products, savory snacks, pizza, sweetened beverages, and breads, rolls, and tortillas, and likely reflect the major sources of UPFs in the veteran diet.¹³ As the statistical comparison between the veteran data and nonveteran data is not feasible in the present study, a future study with a much larger sample size would be needed for a direct comparison.

While the exact cause of higher UPF consumption among sampled veterans remains unknown and likely multifactorial (eg, cost, food insecurity, access, cooking skills, nutrition knowledge), veterans can receive a consult or self-refer to a registered dietitian nutritionist (RDN) for nutrition education. Counseling has been shown to be an effective way to improve diet quality and increase daily fruit and vegetable intake.¹⁴ High consumption of UPFs, which are generally energy-dense and nutrient-poor, contributes to the low diet quality observed in veterans, and future research examining the relationship between UPF intake and overall diet quality among veterans is warranted.^2,15 As nutrition knowledge is associated with higher diet quality among veterans, increased use of nutrition services (ie, nutrition education or food supplement programs) has the potential to influence consumption of MPFs and decrease consumption of UPFs.¹⁶ Subsequently, UPF-targeted interventions developed by VA RDNs hold the promise to decrease consumption of UPFs and increase intake of MPFs and PRFs.

Veterans have a high prevalence of diabetes, hypertension, and obesity.⁹ The high UPF intake observed in this sample of veterans may increase the risk for these chronic diseases and overall mortality. The high percentage of TEI from UPFs among veterans is also of concern not only due to potential negative health outcomes, but also associated costs of treating veterans with multimorbidities.¹⁷ Targeting UPF intake via nutritional education may promote health and decrease the financial burden needed to support the health of veterans.

Improving veteran health and well-being, including enhancing health care accessibility in underserved areas, are pivotal objectives of the VA strategic plan for 2026 to 2030. Public policy aims to tackle food insecurity within the veteran population during the first 5 years of civilian life.¹⁸ In alignment with the White House Strategy on Hunger, Nutrition, and Health, VA established a Food Security Office (FSO) in 2023. The FSO mission is to use an interdisciplinary approach to provide resources to ensure veteran food security and create an environment where all veterans are food and nutrition secure.

Limitations

This study has several limitations. As the Food Processor software database does not include all brand items, similar brands were used to mirror the nutrient profile. While food records are common among veteran diet studies, accuracy may be reduced due to self-reporting bias.¹⁹ Different interpretation of the NOVA classification designation for various food items is possible, however, 89% of foods were coded the same by the research team which suggests high accuracy in food coding. Specific ingredient information was not collected from the 3-day food records; thus, these records were not produced in such a way to improve the accuracy of the NOVA classification designation. This study was limited by its small sample size (N = 79); although, this analysis is larger than other studies of UPF consumption in the US.^20,21 In addition, the generalizability of this study is limited as this population sample was from a single VA hospital and may not reflect the overall veteran population. Participants in this study were recruited only from those receiving VA care, thus their diet quality may not represent the quality consumed by veterans not participating in VA services. Further research on UPF consumption among veterans is warranted with a larger, more representative study sample size.

Conclusions

As this is the highest observed UPF intake documented in the US, these results should be of concern for the VA and its RDNs. More research is needed to better understand why UPF consumption is so high among veterans, what barriers veterans face to decreasing UPF consumption, and what intervention(s) veterans would welcome to improve their diet quality. Presently, veterans are provided with access to a variety of effective nutrition education and counseling options and should be encouraged to use these services. VA RDNs should be aware of the high intake of UPFs in the veteran population and familiarize themselves with education and counseling strategies that promote behavior change to replace UPFs with more nutrient-dense foods choices.

Roughly 8.6% of the 17.4 million US veterans live in poverty. About 11.1% are considered food insecure (ie, unable to acquire adequate food for ≥1 household members), with another 5.3% considered very food insecure (ie, eating patterns of ≥1 household members were disrupted and their food intake was reduced at least some time during the year). Compared with nonveterans, veterans are 7.4% more likely to be food insecure.¹ This high prevalence of food insecurity and poverty has a negative impact on veteran diets.

Veterans’ diets contained more added sugars and solid fats and scored lower compared with nonveterans when assessed for diet quality with the Healthy Eating Index.² Veterans have a higher prevalence of diet-related chronic disease, including diabetes, hypertension, and obesity compared with the nonveterans.^3-5 Given the critical role of diet in health and disease risk, enhancing diet quality among veterans has garnered significant attention and calls to action.^2,6,7 While there are many factors that contribute to diet, any veteran can receive a consultation or self-refer to receive nutrition counseling effective for improving diet quality, within the US Department of Veterans Affairs (VA).

The NOVA food classification system describes diet quality by categorizing food items by processing methods and ingredients into 4 food groups.⁸ The first is unprocessed and minimally processed items (MPFs) such as fresh fruits, vegetables, and meats. MPFs consist of whole foods which can also be minimally processed (eg, chopping, drying, grinding, heating, chilling). Culinary processed foods (CPFs) are processed foods for cooking (eg, salt, butter, and vinegar) and are typically eaten in small quantities along with MPFs. Processed foods (PRFs) include canned and smoked foods, while ultra-processed foods (UPFs) are distinguished by industrial ingredients, requiring specialized tools and processing techniques, and hyper-palatability related to color, flavor, and packaging.⁸ Examples of UPFs include mass-produced breads found at grocery stores, prepackaged snacks and meals, and hydrogenated oils. UPF consumption is associated with higher risk for negative cardiometabolic outcomes, common mental disorders, and all-cause mortality.⁹ To date, only a study by Powell et al has used the NOVA classification system in a veteran population, and it was limited to a comparison of the price of UPFs and veteran body mass index (BMI).¹⁰ Therefore, it remains unknown what percentage of total energy intake (TEI) comes from UPFs in the diets of veterans.

This study sought to quantify the proportion of TEI from UPFs among a sample of patients from the VA Phoenix Health Care System (VAPHCS). Results from a 2021 global meta-analysis reveal that the US and United Kingdom have the highest intakes of UPFs in the world.¹¹ Specifically, within the US, 15 studies with 234,890 participants reveal that the majority of TEI (about 55%) comes from UPFs.¹¹ We hypothesized that this veteran sample would have a higher proportion of TEI from UPFs, possibly due to a higher prevalence of poverty and food insecurity among veterans compared with nonveterans.¹ If the percentage of TEI coming from UPF is higher or even similar to nonveterans, further efforts to increase veterans’ use of the available nutritional services would be warranted to minimize nutrition-related disease among veterans.

Methods

This is a cross-sectional, secondary data analysis of baseline 3-day food records collected from 2017 to 2020 from 92 patients recruited at VAPHCS to participate in a whole-food plant-based diet study.¹² The original study was reviewed and approved by the VAPHCS Institutional Review Board (1593830). Recruitment methods included clinician recommendation, a recorded advertisement played while phone calls were on hold, and flyers distributed throughout VAPHCS. Patients were included if they were aged 18 to 90 years, had a BMI 25.1 to 39.9, had a diagnosis of nutrition-related chronic disease (hypertension, diabetes, or hyperlipidemia), an interest and desire to make a lifestyle change, active telephone contact information (either landline or cell phone), no contraindication to be on a whole-food plant-based diet, access to transportation and a functioning kitchen, ability to prepare meals independently, access to a computer or tablet with internet access, and a digital camera or smartphone. Exclusion criteria included significant unplanned weight loss within 6 months, uncontrolled insulin-dependent diabetes with a current hemoglobin A_1c > 9%, pregnancy/lactation, taking prescribed weight loss medication, currently following a diet (eg, plant-based diet, vegan, or medical weight loss program diet), celiac disease diagnosed within 6 months, end-stage hepatic disease or renal disease requiring dialysis, active cancer or receiving chemotherapy or radiation therapy, active alcohol or substance use disorder, history of eating disorders, fasting triglyceride level > 350 mg/dL, any psychological issues that prevent adherence, inability to speak English, limited mobility, and homeless or in housing with limited kitchen access. A baseline 3-day food record was collected from the participants and used in this secondary analysis.

Diet Analysis

Food records were analyzed using Esha Research Food Processor 4.0 to identify calorie and macronutrient information. To limit bias, food items were coded independently by 2 researchers into 4 food processing groups determined by the NOVA classification: MPF, CPF, PRF, and UPF.⁸ When possible, specific ingredient information was collected using internet searches for brand product websites. Initial coding had an 89% agreement rate for food item coding between the 2 researchers. As coding was done in duplicate, a third researcher resolved disagreements. The number of food items for each processing group was determined and the mean (SD) percentage of TEI for each NOVA group was provided across participants. A 1-way analysis of variance and Tukey Multiple Comparisons Test were used to determine significance between groups with an α = .05 using Prism V9.

Results

Of the 92 participants in the original study, only 79 met inclusion criteria and had baseline diet data. The 79 veterans had a mean (SD) age of 61 (13) years and 59 (75%) were male (Table 1). Mean (SD) TEI was 1921 (815) kcal. The mean (SD) percentage of calories from carbohydrate, fat, and protein were 46% (21%), 39% (20%), and 16% (6%), respectively (Table 2).

A mean (SD) of 36 (12) food items were analyzed from the 3-day food records. The majority of food items were UPFs (56%), 33% were MPFs, 8% were PRFs, and 3% were CPFs. In total, 75% of TEI came from UPFs (P < .001); only 14% of TEI came from minimally processed foods (Figure).

Discussion

To our knowledge, this is the first analysis of UPF consumption among US veterans. TEIs coming from UPFs appear to be about 20% higher among veterans compared to nonveterans: 75% vs 55%.¹¹ Coupled with high UPF consumption, MPFs (14%) and PRFs (9%) represent smaller sources of TEI among surveyed veterans. Top caloric sources of UPFs in the US include sandwiches (including burgers), sweet bakery products, savory snacks, pizza, sweetened beverages, and breads, rolls, and tortillas, and likely reflect the major sources of UPFs in the veteran diet.¹³ As the statistical comparison between the veteran data and nonveteran data is not feasible in the present study, a future study with a much larger sample size would be needed for a direct comparison.

While the exact cause of higher UPF consumption among sampled veterans remains unknown and likely multifactorial (eg, cost, food insecurity, access, cooking skills, nutrition knowledge), veterans can receive a consult or self-refer to a registered dietitian nutritionist (RDN) for nutrition education. Counseling has been shown to be an effective way to improve diet quality and increase daily fruit and vegetable intake.¹⁴ High consumption of UPFs, which are generally energy-dense and nutrient-poor, contributes to the low diet quality observed in veterans, and future research examining the relationship between UPF intake and overall diet quality among veterans is warranted.^2,15 As nutrition knowledge is associated with higher diet quality among veterans, increased use of nutrition services (ie, nutrition education or food supplement programs) has the potential to influence consumption of MPFs and decrease consumption of UPFs.¹⁶ Subsequently, UPF-targeted interventions developed by VA RDNs hold the promise to decrease consumption of UPFs and increase intake of MPFs and PRFs.

Veterans have a high prevalence of diabetes, hypertension, and obesity.⁹ The high UPF intake observed in this sample of veterans may increase the risk for these chronic diseases and overall mortality. The high percentage of TEI from UPFs among veterans is also of concern not only due to potential negative health outcomes, but also associated costs of treating veterans with multimorbidities.¹⁷ Targeting UPF intake via nutritional education may promote health and decrease the financial burden needed to support the health of veterans.

Improving veteran health and well-being, including enhancing health care accessibility in underserved areas, are pivotal objectives of the VA strategic plan for 2026 to 2030. Public policy aims to tackle food insecurity within the veteran population during the first 5 years of civilian life.¹⁸ In alignment with the White House Strategy on Hunger, Nutrition, and Health, VA established a Food Security Office (FSO) in 2023. The FSO mission is to use an interdisciplinary approach to provide resources to ensure veteran food security and create an environment where all veterans are food and nutrition secure.

Limitations

This study has several limitations. As the Food Processor software database does not include all brand items, similar brands were used to mirror the nutrient profile. While food records are common among veteran diet studies, accuracy may be reduced due to self-reporting bias.¹⁹ Different interpretation of the NOVA classification designation for various food items is possible, however, 89% of foods were coded the same by the research team which suggests high accuracy in food coding. Specific ingredient information was not collected from the 3-day food records; thus, these records were not produced in such a way to improve the accuracy of the NOVA classification designation. This study was limited by its small sample size (N = 79); although, this analysis is larger than other studies of UPF consumption in the US.^20,21 In addition, the generalizability of this study is limited as this population sample was from a single VA hospital and may not reflect the overall veteran population. Participants in this study were recruited only from those receiving VA care, thus their diet quality may not represent the quality consumed by veterans not participating in VA services. Further research on UPF consumption among veterans is warranted with a larger, more representative study sample size.

Conclusions

As this is the highest observed UPF intake documented in the US, these results should be of concern for the VA and its RDNs. More research is needed to better understand why UPF consumption is so high among veterans, what barriers veterans face to decreasing UPF consumption, and what intervention(s) veterans would welcome to improve their diet quality. Presently, veterans are provided with access to a variety of effective nutrition education and counseling options and should be encouraged to use these services. VA RDNs should be aware of the high intake of UPFs in the veteran population and familiarize themselves with education and counseling strategies that promote behavior change to replace UPFs with more nutrient-dense foods choices.

Accurate procedural coding is essential to appropriate reimbursement and regulatory compliance in dermatology. This article reviews commonly misunderstood areas of procedural coding, including new biopsy codes; coding for shave removals, destruction, excision and repair, and adjacent tissue transfer (flap closure); the National Correct Coding Initiative; Medicare payment edits; Mohs micrographic surgery (MMS) codes; and correct use of key modifiers. Practical guidance is provided to help avoid frequent errors.

NEW BIOPSY CODES

The most common questions about procedural coding relate to the new Current Procedural Terminology (CPT) biopsy codes, which are reported based on method of removal. Primary codes include the following:

• 11102: tangential biopsy of skin (eg, shave, scoop, saucerize, curette) for a single lesion
• 11104: punch biopsy of skin, including simple closure, when performed, for a single lesion
• 11106: incisional biopsy of skin (eg, wedge), including simple closure, when performed, for a single lesion

Add-on codes are used for each separate or additional lesion:

• 11103: tangential biopsy
• 11105: punch biopsy
• 11107: incisional biopsy

When multiple biopsy types are performed on the same date of service, only one primary code is reported along with add-on codes for any additional biopsies. The primary code reported should have the highest relative value unit (generally incisional > punch > tangential) plus the add-on codes for additional biopsies performed. Sampling of the stratum corneum only (eg, skin scraping or tape stripping) does not constitute a skin biopsy and is not reportable as a procedure.

SHAVE REMOVAL CODES

Shave removal codes are appropriate when the intent is removal of the entire lesion and there is only dermis remaining at the base of the wound. Tangential biopsy codes are appropriate when the intent is to sample a portion of a lesion for diagnosis. If saucerization of a lesion is appropriate and only fat remains at the base of the wound, the procedure is correctly coded as an excision. If any dermis remains at the base of the wound, the procedure is properly coded as shave removal. Shave codes do not distinguish between benign and malignant lesions and do not include the margin of normal skin, only the diameter of the lesion itself.

DESTRUCTION CODES

Destruction codes include both premalignant and benign lesions and may be reported as add-on codes or standalone codes, depending on lesion type and number. The 17000 series is used for destruction of premalignant lesions such as actinic keratosis, large cell acanthoma, actinic cheilitis, and porokeratosis:

• 17000: destruction of the first premalignant lesion
• 17003: destruction of each additional premalignant lesion (up to 13 lesions); reported in addition to 17000
• 17004: destruction of 15 or more premalignant lesions; reported as a standalone code (not in addition to 17000)

The following codes are used for destruction of benign lesions:

• 17110: destruction of benign lesions (up to 14 lesions)
• 17111: destruction of 15 or more benign lesions; reported as a standalone code (not in addition to 17110)

EXCISION AND REPAIR CODES

Individual excisions are reported separately, while repairs are reported as the sum of the lengths within grouped anatomic zones. The groupings differ for intermediate and complex closures, so be sure to refer to your coding manual. Intermediate or complex closures should be reported separately for skin excisions, whereas simple closures are already included in the excision code and are not reported separately. Excision diameter includes the margins necessary to ensure complete removal of the tumor for both benign and malignant tumors. For neoplasms of uncertain behavior, defer billing until pathology results are available to ensure accurate reporting as either a benign or malignant tumor excision. Lesion size is measured prior to excision and includes the lesion plus the narrowest intended clinical margin; this measurement reflects the width of the excised specimen rather than the length of the repair.

Malignant tumor excisions continue to be worth more because of the greater risk and preservice and postservice work involved. Only about 50% of payment relates to the procedure itself; the other 50% relates to risk and preoperative and postoperative counseling as well as bundled follow-up visits in the global period. That accounts for the difference in compensation for benign vs malignant tumors as well as the 50% multiple surgical reduction for multiple lesions, as the equipment and cognitive portion bundled into the procedure are not separate for each procedure.

Historically, Medicare has bundled complex closures with benign excisions under 0.5 cm. Medicare also applies medically unlikely edits that may limit payment when more than 5 excisions, closures, or destruction procedures (excluding add-on codes) are reported on the same date of service. Medicare may pay for the additional procedures if a copy of the record and a letter of medical necessity are included.

CODING FOR ADJACENT TISSUE TRANSFER (FLAP CLOSURE)

When reporting adjacent tissue transfers, the total size of the defect includes primary and secondary defects when calculating the area of the flap. The areas of the primary and secondary defects are added together when the flap represents a single repair. The sums are reported separately if they are distinct repairs. Adjacent tissue transfer already includes payment for the excision of malignant or benign lesions. Do not code separately for the excision.

CORRECT CODING INITIATIVE

On January 1, 1996, the Medicare program implemented the National Correct Coding Initiative (https://www.cms.gov/national-correct-coding-initiative-ncci), employing nearly 83,000 code edits, in an attempt to eliminate unbundling or other inappropriate reporting of CPT codes. When procedures are performed on separate and distinct lesions, a modifier is required to bypass the edit that would otherwise deny payment for the second procedure. Medicare publishes lists of paired codes (column 1 paired with column 2). The code in column 2 is the one that requires modifier 59 or 79.

MEDICARE PAYMENT EDITS

Mutually Exclusive Edits

Mutually exclusive edits seek to identify services that cannot reasonably be performed in the same session. The “comprehensive” code will be paid and the “component” code disallowed.

Medically Unlikely Edits

The Centers for Medicare & Medicaid Services stop paying when multiples of a procedure exceed the medically unlikely edits, but payment may be made if accompanied by a copy of the medical record and letter of medical necessity. A common example would be a transplant recipient requiring destruction of many malignant lesions in a single session, exceeding the medically unlikely edits for the procedure.

MOHS MICROGRAPHIC SURGERY CODES

Mohs micrographic surgery codes require that a single physician act as both surgeon and pathologist. Do not report 88305 separately, as the pathology interpretation is already included in the MMS reimbursement. Repairs, grafts, and adjacent tissue transfer are separately reportable with the CPT codes for MMS.

The CPT codes for MMS include skin biopsy and excision services (11102-11107, 11600-11646, and 17260-17286); however, if a suspected skin cancer is biopsied for pathologic diagnosis prior to MMS, the biopsy (11102-11107) and frozen section pathology (88331) may be reported separately utilizing modifier 59 or 58 to distinguish the diagnostic biopsy from the definitive MMS. The biopsy should not duplicate a prior biopsy unless that biopsy result cannot be located; it must be performed before MMS and must determine the subsequent procedure. Although CPT indicates that modifier 59 should be used, it also is acceptable to utilize modifier 58 to indicate that the diagnostic skin biopsy and MMS were staged or planned procedures. This may be appropriate in the following scenarios:

• The lesion for which MMS is planned has not been biopsied within the previous 60 days,
• The surgeon cannot obtain a pathology report, with reasonable effort, from the referring physician, or
• The biopsy is performed on a lesion that is not associated with the MMS.

KEY MODIFIERS AND HOW THEY ARE USED

Modifiers are essential tools in dermatology coding that are used to indicate when procedures or evaluation and management (E/M) services are distinct, staged, bilateral, or related to specific global periods. Correct application ensures accurate reimbursement, prevents claim denials, and reflects the true work performed. The following list summarizes commonly used modifiers and guidance for their proper use.

Modifier 59: Distinct Procedural Service

Modifier 59 is used to clearly designate when distinct, independent, and separate multiple procedures are provided. The procedure must not be a component of another procedure. Examples include:

• Different procedures or surgeries
• Surgery on different sites or organ systems
• Separate incision/excision
• Separate lesions

When code 17000 is paired with the new biopsy codes, modifier 59 is paired with code 17000.

Modifier 79: Distinct Procedural Service During a Postoperative Period

Modifier 79 is used to clearly designate when distinct, independent, and separate multiple procedures are provided. The procedure must not be a component of another procedure. Examples include:

• Different procedures or surgeries
• Surgery on different sites or organ systems
• Separate incision/excision
• Separate lesions

Modifier 58: Staged or Planned Procedure

Modifier 58 is most commonly used when a staged excision is planned in advance or when a positive tumor margin requires further excision during a global period.

Modifier 25: Significant, Separately Identifiable E/M Service

Modifier 25 is defined as a significant and separately identifiable E/M service performed by the same physician on the same day as a procedure or other service. It is used to describe a separate, distinctly identifiable E/M service rendered during the same visit as another procedure. The modifier must be appended to the E/M code. The decision to perform a 0- or 10-day global procedure on the same date of service is already bundled into the payment for the procedure and does not qualify as a separate billable service.

Modifier 24: Unrelated E/M Service During a Postoperative Period

Modifier 24 is defined as an unrelated E/M service performed by the same physician during a postoperative period. It is used when a separate, unrelated E/M service is provided during the global period of a surgical procedure.

Modifiers 24 and 25: Documentation and Distinction

The CPT definition of modifier 25 states that an E/M service may be prompted by the system or condition for which a separate procedure or service is needed. Neither modifier requires a separate diagnosis; however, both require clearly distinguishable cognitive services beyond those typically associated with the procedure itself. This includes evaluation beyond the examination of the lesion, discussion of risks, benefits, and alternatives, and the decision to perform a 0- or 10-day global procedure.

Modifier 50: Bilateral Procedure

Modifier 50 is defined as a bilateral procedure and is used when the same procedure is performed on both sides of the body, such as application of Unna boots. When reporting this modifier, specify the quantity applied. Because Unna boots may be required on the arms as well as the legs, the billing system cannot determine how many were applied unless the quantity is clearly indicated.

Modifier 57: Decision for Surgery

Modifier 57 is reported when an E/M service involves the decision to perform a 90-day global procedure on the same date of service. For 10-day global procedures, the decision to perform surgery on the same day does not justify a separate E/M service. The global period timing begins at midnight, with the 10-day global starting on the day of the procedure and the 90-day global starting the day before the procedure; for example, if an excision is performed today and an adjacent tissue transfer is performed tomorrow, the excision is considered within the global period.

FINAL THOUGHTS

Physicians remain responsible for accurately selecting diagnosis and procedure codes that reflect medically necessary services, and CPT codes continue to define the procedures that are reported. The Relative Value Scale Update Committee determines the value of each procedure based on physician survey data, including time and follow-up visit utilization, as well as practice expense, which represents a substantial portion of each code’s value. Our specialty relies on dedicated volunteers who devote significant time and effort to ensuring accurate representation of the work we perform for our patients. When the opportunity arises, please thank them for their service.

Accurate procedural coding is essential to appropriate reimbursement and regulatory compliance in dermatology. This article reviews commonly misunderstood areas of procedural coding, including new biopsy codes; coding for shave removals, destruction, excision and repair, and adjacent tissue transfer (flap closure); the National Correct Coding Initiative; Medicare payment edits; Mohs micrographic surgery (MMS) codes; and correct use of key modifiers. Practical guidance is provided to help avoid frequent errors.

NEW BIOPSY CODES

The most common questions about procedural coding relate to the new Current Procedural Terminology (CPT) biopsy codes, which are reported based on method of removal. Primary codes include the following:

• 11102: tangential biopsy of skin (eg, shave, scoop, saucerize, curette) for a single lesion
• 11104: punch biopsy of skin, including simple closure, when performed, for a single lesion
• 11106: incisional biopsy of skin (eg, wedge), including simple closure, when performed, for a single lesion

Add-on codes are used for each separate or additional lesion:

• 11103: tangential biopsy
• 11105: punch biopsy
• 11107: incisional biopsy

When multiple biopsy types are performed on the same date of service, only one primary code is reported along with add-on codes for any additional biopsies. The primary code reported should have the highest relative value unit (generally incisional > punch > tangential) plus the add-on codes for additional biopsies performed. Sampling of the stratum corneum only (eg, skin scraping or tape stripping) does not constitute a skin biopsy and is not reportable as a procedure.

SHAVE REMOVAL CODES

Shave removal codes are appropriate when the intent is removal of the entire lesion and there is only dermis remaining at the base of the wound. Tangential biopsy codes are appropriate when the intent is to sample a portion of a lesion for diagnosis. If saucerization of a lesion is appropriate and only fat remains at the base of the wound, the procedure is correctly coded as an excision. If any dermis remains at the base of the wound, the procedure is properly coded as shave removal. Shave codes do not distinguish between benign and malignant lesions and do not include the margin of normal skin, only the diameter of the lesion itself.

DESTRUCTION CODES

Destruction codes include both premalignant and benign lesions and may be reported as add-on codes or standalone codes, depending on lesion type and number. The 17000 series is used for destruction of premalignant lesions such as actinic keratosis, large cell acanthoma, actinic cheilitis, and porokeratosis:

• 17000: destruction of the first premalignant lesion
• 17003: destruction of each additional premalignant lesion (up to 13 lesions); reported in addition to 17000
• 17004: destruction of 15 or more premalignant lesions; reported as a standalone code (not in addition to 17000)

The following codes are used for destruction of benign lesions:

• 17110: destruction of benign lesions (up to 14 lesions)
• 17111: destruction of 15 or more benign lesions; reported as a standalone code (not in addition to 17110)

EXCISION AND REPAIR CODES

Individual excisions are reported separately, while repairs are reported as the sum of the lengths within grouped anatomic zones. The groupings differ for intermediate and complex closures, so be sure to refer to your coding manual. Intermediate or complex closures should be reported separately for skin excisions, whereas simple closures are already included in the excision code and are not reported separately. Excision diameter includes the margins necessary to ensure complete removal of the tumor for both benign and malignant tumors. For neoplasms of uncertain behavior, defer billing until pathology results are available to ensure accurate reporting as either a benign or malignant tumor excision. Lesion size is measured prior to excision and includes the lesion plus the narrowest intended clinical margin; this measurement reflects the width of the excised specimen rather than the length of the repair.

Malignant tumor excisions continue to be worth more because of the greater risk and preservice and postservice work involved. Only about 50% of payment relates to the procedure itself; the other 50% relates to risk and preoperative and postoperative counseling as well as bundled follow-up visits in the global period. That accounts for the difference in compensation for benign vs malignant tumors as well as the 50% multiple surgical reduction for multiple lesions, as the equipment and cognitive portion bundled into the procedure are not separate for each procedure.

Historically, Medicare has bundled complex closures with benign excisions under 0.5 cm. Medicare also applies medically unlikely edits that may limit payment when more than 5 excisions, closures, or destruction procedures (excluding add-on codes) are reported on the same date of service. Medicare may pay for the additional procedures if a copy of the record and a letter of medical necessity are included.

CODING FOR ADJACENT TISSUE TRANSFER (FLAP CLOSURE)

When reporting adjacent tissue transfers, the total size of the defect includes primary and secondary defects when calculating the area of the flap. The areas of the primary and secondary defects are added together when the flap represents a single repair. The sums are reported separately if they are distinct repairs. Adjacent tissue transfer already includes payment for the excision of malignant or benign lesions. Do not code separately for the excision.

CORRECT CODING INITIATIVE

On January 1, 1996, the Medicare program implemented the National Correct Coding Initiative (https://www.cms.gov/national-correct-coding-initiative-ncci), employing nearly 83,000 code edits, in an attempt to eliminate unbundling or other inappropriate reporting of CPT codes. When procedures are performed on separate and distinct lesions, a modifier is required to bypass the edit that would otherwise deny payment for the second procedure. Medicare publishes lists of paired codes (column 1 paired with column 2). The code in column 2 is the one that requires modifier 59 or 79.

MEDICARE PAYMENT EDITS

Mutually Exclusive Edits

Mutually exclusive edits seek to identify services that cannot reasonably be performed in the same session. The “comprehensive” code will be paid and the “component” code disallowed.

Medically Unlikely Edits

The Centers for Medicare & Medicaid Services stop paying when multiples of a procedure exceed the medically unlikely edits, but payment may be made if accompanied by a copy of the medical record and letter of medical necessity. A common example would be a transplant recipient requiring destruction of many malignant lesions in a single session, exceeding the medically unlikely edits for the procedure.

MOHS MICROGRAPHIC SURGERY CODES

Mohs micrographic surgery codes require that a single physician act as both surgeon and pathologist. Do not report 88305 separately, as the pathology interpretation is already included in the MMS reimbursement. Repairs, grafts, and adjacent tissue transfer are separately reportable with the CPT codes for MMS.

The CPT codes for MMS include skin biopsy and excision services (11102-11107, 11600-11646, and 17260-17286); however, if a suspected skin cancer is biopsied for pathologic diagnosis prior to MMS, the biopsy (11102-11107) and frozen section pathology (88331) may be reported separately utilizing modifier 59 or 58 to distinguish the diagnostic biopsy from the definitive MMS. The biopsy should not duplicate a prior biopsy unless that biopsy result cannot be located; it must be performed before MMS and must determine the subsequent procedure. Although CPT indicates that modifier 59 should be used, it also is acceptable to utilize modifier 58 to indicate that the diagnostic skin biopsy and MMS were staged or planned procedures. This may be appropriate in the following scenarios:

• The lesion for which MMS is planned has not been biopsied within the previous 60 days,
• The surgeon cannot obtain a pathology report, with reasonable effort, from the referring physician, or
• The biopsy is performed on a lesion that is not associated with the MMS.

KEY MODIFIERS AND HOW THEY ARE USED

Modifiers are essential tools in dermatology coding that are used to indicate when procedures or evaluation and management (E/M) services are distinct, staged, bilateral, or related to specific global periods. Correct application ensures accurate reimbursement, prevents claim denials, and reflects the true work performed. The following list summarizes commonly used modifiers and guidance for their proper use.

Modifier 59: Distinct Procedural Service

Modifier 59 is used to clearly designate when distinct, independent, and separate multiple procedures are provided. The procedure must not be a component of another procedure. Examples include:

• Different procedures or surgeries
• Surgery on different sites or organ systems
• Separate incision/excision
• Separate lesions

When code 17000 is paired with the new biopsy codes, modifier 59 is paired with code 17000.

Modifier 79: Distinct Procedural Service During a Postoperative Period

Modifier 79 is used to clearly designate when distinct, independent, and separate multiple procedures are provided. The procedure must not be a component of another procedure. Examples include:

• Different procedures or surgeries
• Surgery on different sites or organ systems
• Separate incision/excision
• Separate lesions

Modifier 58: Staged or Planned Procedure

Modifier 58 is most commonly used when a staged excision is planned in advance or when a positive tumor margin requires further excision during a global period.

Modifier 25: Significant, Separately Identifiable E/M Service

Modifier 25 is defined as a significant and separately identifiable E/M service performed by the same physician on the same day as a procedure or other service. It is used to describe a separate, distinctly identifiable E/M service rendered during the same visit as another procedure. The modifier must be appended to the E/M code. The decision to perform a 0- or 10-day global procedure on the same date of service is already bundled into the payment for the procedure and does not qualify as a separate billable service.

Modifier 24: Unrelated E/M Service During a Postoperative Period

Modifier 24 is defined as an unrelated E/M service performed by the same physician during a postoperative period. It is used when a separate, unrelated E/M service is provided during the global period of a surgical procedure.

Modifiers 24 and 25: Documentation and Distinction

The CPT definition of modifier 25 states that an E/M service may be prompted by the system or condition for which a separate procedure or service is needed. Neither modifier requires a separate diagnosis; however, both require clearly distinguishable cognitive services beyond those typically associated with the procedure itself. This includes evaluation beyond the examination of the lesion, discussion of risks, benefits, and alternatives, and the decision to perform a 0- or 10-day global procedure.

Modifier 50: Bilateral Procedure

Modifier 50 is defined as a bilateral procedure and is used when the same procedure is performed on both sides of the body, such as application of Unna boots. When reporting this modifier, specify the quantity applied. Because Unna boots may be required on the arms as well as the legs, the billing system cannot determine how many were applied unless the quantity is clearly indicated.

Modifier 57: Decision for Surgery

Modifier 57 is reported when an E/M service involves the decision to perform a 90-day global procedure on the same date of service. For 10-day global procedures, the decision to perform surgery on the same day does not justify a separate E/M service. The global period timing begins at midnight, with the 10-day global starting on the day of the procedure and the 90-day global starting the day before the procedure; for example, if an excision is performed today and an adjacent tissue transfer is performed tomorrow, the excision is considered within the global period.

FINAL THOUGHTS

Physicians remain responsible for accurately selecting diagnosis and procedure codes that reflect medically necessary services, and CPT codes continue to define the procedures that are reported. The Relative Value Scale Update Committee determines the value of each procedure based on physician survey data, including time and follow-up visit utilization, as well as practice expense, which represents a substantial portion of each code’s value. Our specialty relies on dedicated volunteers who devote significant time and effort to ensuring accurate representation of the work we perform for our patients. When the opportunity arises, please thank them for their service.

Accurate procedural coding is essential to appropriate reimbursement and regulatory compliance in dermatology. This article reviews commonly misunderstood areas of procedural coding, including new biopsy codes; coding for shave removals, destruction, excision and repair, and adjacent tissue transfer (flap closure); the National Correct Coding Initiative; Medicare payment edits; Mohs micrographic surgery (MMS) codes; and correct use of key modifiers. Practical guidance is provided to help avoid frequent errors.

NEW BIOPSY CODES

The most common questions about procedural coding relate to the new Current Procedural Terminology (CPT) biopsy codes, which are reported based on method of removal. Primary codes include the following:

• 11102: tangential biopsy of skin (eg, shave, scoop, saucerize, curette) for a single lesion
• 11104: punch biopsy of skin, including simple closure, when performed, for a single lesion
• 11106: incisional biopsy of skin (eg, wedge), including simple closure, when performed, for a single lesion

Add-on codes are used for each separate or additional lesion:

• 11103: tangential biopsy
• 11105: punch biopsy
• 11107: incisional biopsy

When multiple biopsy types are performed on the same date of service, only one primary code is reported along with add-on codes for any additional biopsies. The primary code reported should have the highest relative value unit (generally incisional > punch > tangential) plus the add-on codes for additional biopsies performed. Sampling of the stratum corneum only (eg, skin scraping or tape stripping) does not constitute a skin biopsy and is not reportable as a procedure.

SHAVE REMOVAL CODES

Shave removal codes are appropriate when the intent is removal of the entire lesion and there is only dermis remaining at the base of the wound. Tangential biopsy codes are appropriate when the intent is to sample a portion of a lesion for diagnosis. If saucerization of a lesion is appropriate and only fat remains at the base of the wound, the procedure is correctly coded as an excision. If any dermis remains at the base of the wound, the procedure is properly coded as shave removal. Shave codes do not distinguish between benign and malignant lesions and do not include the margin of normal skin, only the diameter of the lesion itself.

DESTRUCTION CODES

Destruction codes include both premalignant and benign lesions and may be reported as add-on codes or standalone codes, depending on lesion type and number. The 17000 series is used for destruction of premalignant lesions such as actinic keratosis, large cell acanthoma, actinic cheilitis, and porokeratosis:

• 17000: destruction of the first premalignant lesion
• 17003: destruction of each additional premalignant lesion (up to 13 lesions); reported in addition to 17000
• 17004: destruction of 15 or more premalignant lesions; reported as a standalone code (not in addition to 17000)

The following codes are used for destruction of benign lesions:

• 17110: destruction of benign lesions (up to 14 lesions)
• 17111: destruction of 15 or more benign lesions; reported as a standalone code (not in addition to 17110)

EXCISION AND REPAIR CODES

Individual excisions are reported separately, while repairs are reported as the sum of the lengths within grouped anatomic zones. The groupings differ for intermediate and complex closures, so be sure to refer to your coding manual. Intermediate or complex closures should be reported separately for skin excisions, whereas simple closures are already included in the excision code and are not reported separately. Excision diameter includes the margins necessary to ensure complete removal of the tumor for both benign and malignant tumors. For neoplasms of uncertain behavior, defer billing until pathology results are available to ensure accurate reporting as either a benign or malignant tumor excision. Lesion size is measured prior to excision and includes the lesion plus the narrowest intended clinical margin; this measurement reflects the width of the excised specimen rather than the length of the repair.

Malignant tumor excisions continue to be worth more because of the greater risk and preservice and postservice work involved. Only about 50% of payment relates to the procedure itself; the other 50% relates to risk and preoperative and postoperative counseling as well as bundled follow-up visits in the global period. That accounts for the difference in compensation for benign vs malignant tumors as well as the 50% multiple surgical reduction for multiple lesions, as the equipment and cognitive portion bundled into the procedure are not separate for each procedure.

Historically, Medicare has bundled complex closures with benign excisions under 0.5 cm. Medicare also applies medically unlikely edits that may limit payment when more than 5 excisions, closures, or destruction procedures (excluding add-on codes) are reported on the same date of service. Medicare may pay for the additional procedures if a copy of the record and a letter of medical necessity are included.

CODING FOR ADJACENT TISSUE TRANSFER (FLAP CLOSURE)

When reporting adjacent tissue transfers, the total size of the defect includes primary and secondary defects when calculating the area of the flap. The areas of the primary and secondary defects are added together when the flap represents a single repair. The sums are reported separately if they are distinct repairs. Adjacent tissue transfer already includes payment for the excision of malignant or benign lesions. Do not code separately for the excision.

CORRECT CODING INITIATIVE

On January 1, 1996, the Medicare program implemented the National Correct Coding Initiative (https://www.cms.gov/national-correct-coding-initiative-ncci), employing nearly 83,000 code edits, in an attempt to eliminate unbundling or other inappropriate reporting of CPT codes. When procedures are performed on separate and distinct lesions, a modifier is required to bypass the edit that would otherwise deny payment for the second procedure. Medicare publishes lists of paired codes (column 1 paired with column 2). The code in column 2 is the one that requires modifier 59 or 79.

MEDICARE PAYMENT EDITS

Mutually Exclusive Edits

Mutually exclusive edits seek to identify services that cannot reasonably be performed in the same session. The “comprehensive” code will be paid and the “component” code disallowed.

Medically Unlikely Edits

The Centers for Medicare & Medicaid Services stop paying when multiples of a procedure exceed the medically unlikely edits, but payment may be made if accompanied by a copy of the medical record and letter of medical necessity. A common example would be a transplant recipient requiring destruction of many malignant lesions in a single session, exceeding the medically unlikely edits for the procedure.

MOHS MICROGRAPHIC SURGERY CODES

Mohs micrographic surgery codes require that a single physician act as both surgeon and pathologist. Do not report 88305 separately, as the pathology interpretation is already included in the MMS reimbursement. Repairs, grafts, and adjacent tissue transfer are separately reportable with the CPT codes for MMS.

The CPT codes for MMS include skin biopsy and excision services (11102-11107, 11600-11646, and 17260-17286); however, if a suspected skin cancer is biopsied for pathologic diagnosis prior to MMS, the biopsy (11102-11107) and frozen section pathology (88331) may be reported separately utilizing modifier 59 or 58 to distinguish the diagnostic biopsy from the definitive MMS. The biopsy should not duplicate a prior biopsy unless that biopsy result cannot be located; it must be performed before MMS and must determine the subsequent procedure. Although CPT indicates that modifier 59 should be used, it also is acceptable to utilize modifier 58 to indicate that the diagnostic skin biopsy and MMS were staged or planned procedures. This may be appropriate in the following scenarios:

• The lesion for which MMS is planned has not been biopsied within the previous 60 days,
• The surgeon cannot obtain a pathology report, with reasonable effort, from the referring physician, or
• The biopsy is performed on a lesion that is not associated with the MMS.

KEY MODIFIERS AND HOW THEY ARE USED

Modifiers are essential tools in dermatology coding that are used to indicate when procedures or evaluation and management (E/M) services are distinct, staged, bilateral, or related to specific global periods. Correct application ensures accurate reimbursement, prevents claim denials, and reflects the true work performed. The following list summarizes commonly used modifiers and guidance for their proper use.

Modifier 59: Distinct Procedural Service

Modifier 59 is used to clearly designate when distinct, independent, and separate multiple procedures are provided. The procedure must not be a component of another procedure. Examples include:

• Different procedures or surgeries
• Surgery on different sites or organ systems
• Separate incision/excision
• Separate lesions

When code 17000 is paired with the new biopsy codes, modifier 59 is paired with code 17000.

Modifier 79: Distinct Procedural Service During a Postoperative Period

Modifier 79 is used to clearly designate when distinct, independent, and separate multiple procedures are provided. The procedure must not be a component of another procedure. Examples include:

• Different procedures or surgeries
• Surgery on different sites or organ systems
• Separate incision/excision
• Separate lesions

Modifier 58: Staged or Planned Procedure

Modifier 58 is most commonly used when a staged excision is planned in advance or when a positive tumor margin requires further excision during a global period.

Modifier 25: Significant, Separately Identifiable E/M Service

Modifier 25 is defined as a significant and separately identifiable E/M service performed by the same physician on the same day as a procedure or other service. It is used to describe a separate, distinctly identifiable E/M service rendered during the same visit as another procedure. The modifier must be appended to the E/M code. The decision to perform a 0- or 10-day global procedure on the same date of service is already bundled into the payment for the procedure and does not qualify as a separate billable service.

Modifier 24: Unrelated E/M Service During a Postoperative Period

Modifier 24 is defined as an unrelated E/M service performed by the same physician during a postoperative period. It is used when a separate, unrelated E/M service is provided during the global period of a surgical procedure.

Modifiers 24 and 25: Documentation and Distinction

The CPT definition of modifier 25 states that an E/M service may be prompted by the system or condition for which a separate procedure or service is needed. Neither modifier requires a separate diagnosis; however, both require clearly distinguishable cognitive services beyond those typically associated with the procedure itself. This includes evaluation beyond the examination of the lesion, discussion of risks, benefits, and alternatives, and the decision to perform a 0- or 10-day global procedure.

Modifier 50: Bilateral Procedure

Modifier 50 is defined as a bilateral procedure and is used when the same procedure is performed on both sides of the body, such as application of Unna boots. When reporting this modifier, specify the quantity applied. Because Unna boots may be required on the arms as well as the legs, the billing system cannot determine how many were applied unless the quantity is clearly indicated.

Modifier 57: Decision for Surgery

Modifier 57 is reported when an E/M service involves the decision to perform a 90-day global procedure on the same date of service. For 10-day global procedures, the decision to perform surgery on the same day does not justify a separate E/M service. The global period timing begins at midnight, with the 10-day global starting on the day of the procedure and the 90-day global starting the day before the procedure; for example, if an excision is performed today and an adjacent tissue transfer is performed tomorrow, the excision is considered within the global period.

FINAL THOUGHTS

Physicians remain responsible for accurately selecting diagnosis and procedure codes that reflect medically necessary services, and CPT codes continue to define the procedures that are reported. The Relative Value Scale Update Committee determines the value of each procedure based on physician survey data, including time and follow-up visit utilization, as well as practice expense, which represents a substantial portion of each code’s value. Our specialty relies on dedicated volunteers who devote significant time and effort to ensuring accurate representation of the work we perform for our patients. When the opportunity arises, please thank them for their service.

THE DIAGNOSIS: Pigmented Bowen Disease

Histopathology revealed atypical keratinocytes throughout the entire thickness of a pigmented epidermis extending from the basal layer (Figure). Diffuse epidermal hyperpigmentation and melanophages in the papillary dermis were present. There was no dermal invasion or atypical melanocytic proliferation. On dermoscopy, this lesion had small brown globules, smudging, and an asymmetric nonspecific homogeneous pattern. Based on these features as well as the clinical findings, a diagnosis of pigmented Bowen disease (PBD), a rare subtype of squamous cell carcinoma in situ, was made. Complete removal of the lesion was achieved via the biopsy, and the patient was counselled regarding the malignant but noninvasive nature of the lesion. Appropriate follow-up was recommended to monitor for recurrence.

Our case presentation of PBD on the right upper arm in a female patient with a light skin tone is not classic, as PBD lesions usually manifest as well-demarcated scaly plaques on sun-protected sites in men with darker skin tones who are in the sixth to seventh decades of life.¹

Dermoscopy of PBD in patients with lighter skin tones can present diagnostic challenges because characteristic clustered glomerular vessels may be faint or absent, particularly in small lesions such as this one. In such cases, PBD may instead demonstrate structureless brown pigmentation and irregular globules, patterns that overlap with pigmented actinic keratosis (PAK) and melanoma.³

Our case underscores the importance of maintaining a broad differential when evaluating small pigmented macules and reinforces biopsy as the diagnostic gold standard for PBD when dermoscopic findings are nonspecific.

THE DIAGNOSIS: Pigmented Bowen Disease

Histopathology revealed atypical keratinocytes throughout the entire thickness of a pigmented epidermis extending from the basal layer (Figure). Diffuse epidermal hyperpigmentation and melanophages in the papillary dermis were present. There was no dermal invasion or atypical melanocytic proliferation. On dermoscopy, this lesion had small brown globules, smudging, and an asymmetric nonspecific homogeneous pattern. Based on these features as well as the clinical findings, a diagnosis of pigmented Bowen disease (PBD), a rare subtype of squamous cell carcinoma in situ, was made. Complete removal of the lesion was achieved via the biopsy, and the patient was counselled regarding the malignant but noninvasive nature of the lesion. Appropriate follow-up was recommended to monitor for recurrence.

Our case presentation of PBD on the right upper arm in a female patient with a light skin tone is not classic, as PBD lesions usually manifest as well-demarcated scaly plaques on sun-protected sites in men with darker skin tones who are in the sixth to seventh decades of life.¹

Dermoscopy of PBD in patients with lighter skin tones can present diagnostic challenges because characteristic clustered glomerular vessels may be faint or absent, particularly in small lesions such as this one. In such cases, PBD may instead demonstrate structureless brown pigmentation and irregular globules, patterns that overlap with pigmented actinic keratosis (PAK) and melanoma.³

Our case underscores the importance of maintaining a broad differential when evaluating small pigmented macules and reinforces biopsy as the diagnostic gold standard for PBD when dermoscopic findings are nonspecific.

THE DIAGNOSIS: Pigmented Bowen Disease

Histopathology revealed atypical keratinocytes throughout the entire thickness of a pigmented epidermis extending from the basal layer (Figure). Diffuse epidermal hyperpigmentation and melanophages in the papillary dermis were present. There was no dermal invasion or atypical melanocytic proliferation. On dermoscopy, this lesion had small brown globules, smudging, and an asymmetric nonspecific homogeneous pattern. Based on these features as well as the clinical findings, a diagnosis of pigmented Bowen disease (PBD), a rare subtype of squamous cell carcinoma in situ, was made. Complete removal of the lesion was achieved via the biopsy, and the patient was counselled regarding the malignant but noninvasive nature of the lesion. Appropriate follow-up was recommended to monitor for recurrence.

Our case presentation of PBD on the right upper arm in a female patient with a light skin tone is not classic, as PBD lesions usually manifest as well-demarcated scaly plaques on sun-protected sites in men with darker skin tones who are in the sixth to seventh decades of life.¹

Dermoscopy of PBD in patients with lighter skin tones can present diagnostic challenges because characteristic clustered glomerular vessels may be faint or absent, particularly in small lesions such as this one. In such cases, PBD may instead demonstrate structureless brown pigmentation and irregular globules, patterns that overlap with pigmented actinic keratosis (PAK) and melanoma.³

Our case underscores the importance of maintaining a broad differential when evaluating small pigmented macules and reinforces biopsy as the diagnostic gold standard for PBD when dermoscopic findings are nonspecific.