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FDA Approves IL-13 inhibitor for Atopic Dermatitis

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Mon, 09/16/2024 - 10:35

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).



According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

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The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).



According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).



According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

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A 14-Year-Old Female Presents With a Growth Under Her Toenail

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Fri, 09/13/2024 - 15:17

 

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.1

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.2

MiLo Studios
Xochitl Longstaff

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.3 However, the recurrence rate is also generally low, around 4%.1

courtesy University of Miami
Dr. Angelina Labib

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego
Dr. Dawn Eichenfield

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

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BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.1

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.2

MiLo Studios
Xochitl Longstaff

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.3 However, the recurrence rate is also generally low, around 4%.1

courtesy University of Miami
Dr. Angelina Labib

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego
Dr. Dawn Eichenfield

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

 

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.1

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.2

MiLo Studios
Xochitl Longstaff

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.3 However, the recurrence rate is also generally low, around 4%.1

courtesy University of Miami
Dr. Angelina Labib

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego
Dr. Dawn Eichenfield

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

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A 14-year-old healthy female presents with a painful nodule under her great toenail. The nodule had been present for 2 months and there was no preceding trauma. Three days prior to presentation, her nail cracked and bled after bumping her toe. The toe is painful to palpation. Given the associated pain, the patient visited urgent care and was prescribed cephalexin and acetaminophen.  
Physical examination reveals a skin-colored subungual nodule with hypertrophic tissue originating from the nail bed of the right great toe, but no thickening of the nail plate (Figures 1-3).

 

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Are Pharmacy Deserts Worsening Health Disparities?

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Fri, 09/13/2024 - 11:14

 

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

  • Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
  • Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
  • Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
  • PCP density was calculated as the number of PCPs per 10,000 inhabitants.
  • A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

  • Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
  • Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
  • High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
  • Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

  • Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
  • Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
  • Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
  • PCP density was calculated as the number of PCPs per 10,000 inhabitants.
  • A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

  • Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
  • Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
  • High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
  • Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

  • Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
  • Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
  • Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
  • PCP density was calculated as the number of PCPs per 10,000 inhabitants.
  • A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

  • Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
  • Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
  • High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
  • Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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UVA Defends Medical School Dean, Hospital CEO After Docs Call for Their Removal

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Thu, 09/12/2024 - 14:18

 

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

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The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

 

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

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Current Hydroxychloroquine Use in Lupus May Provide Protection Against Cardiovascular Events

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Wed, 09/11/2024 - 14:33

 

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

  • Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
  • They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
  • Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
  • Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
  • The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

  • Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
  • The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
  • No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

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

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TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

  • Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
  • They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
  • Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
  • Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
  • The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

  • Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
  • The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
  • No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

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

 

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

  • Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
  • They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
  • Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
  • Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
  • The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

  • Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
  • The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
  • No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

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

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Do Cannabis Users Need More Anesthesia During Surgery?

Article Type
Changed
Wed, 09/11/2024 - 11:17

 

TOPLINE: 

Cannabis users aged 65 years or older undergoing general anesthesia for surgery required higher doses of inhalational anesthetics than nonusers. However, the clinical relevance of this difference remains unclear.

METHODOLOGY:

  • To assess if cannabis use leads to higher doses of inhalational anesthesia during surgery, the researchers conducted a retrospective cohort study comparing the average intraoperative minimum alveolar concentrations of volatile anesthetics (isoflurane and sevoflurane) between older adults who used cannabis products and those who did not.
  • The researchers reviewed electronic health records of 22,476 patients aged 65 years or older who underwent surgery at the University of Florida Health System between 2018 and 2020.
  • Overall, 268 patients who reported using cannabis within 60 days of surgery (median age, 69 years; 35% women) were matched to 1072 nonusers.
  • The median duration of anesthesia was 175 minutes.
  • The primary outcome was the intraoperative time-weighted average of isoflurane or sevoflurane minimum alveolar concentration equivalents.

TAKEAWAY:

  • Cannabis users had significantly higher average minimum alveolar concentrations of isoflurane or sevoflurane than nonusers (mean, 0.58 vs 0.54; mean difference, 0.04; P = .021).
  • The findings were confirmed in a sensitivity analysis that revealed higher mean average minimum alveolar concentrations of anesthesia in cannabis users than in nonusers (0.57 vs 0.53; P = .029).
  • Although the 0.04 difference in minimum alveolar concentration between cannabis users and nonusers was statistically significant, its clinical importance is unclear.

IN PRACTICE:

“While recent guidelines underscore the importance of universal screening for cannabinoids before surgery, caution is paramount to prevent clinical bias leading to the administration of unnecessary higher doses of inhalational anesthesia, especially as robust evidence supporting such practices remains lacking,” the authors of the study wrote.
 

SOURCE:

This study was led by Ruba Sajdeya, MD, PhD, of the Department of Epidemiology at the University of Florida, Gainesville, and was published online in August 2024 in Anesthesiology.

LIMITATIONS: 

This study lacked access to prescription or dispensed medications, including opioids, which may have introduced residual confounding. Potential underdocumentation of cannabis use in medical records could have led to exposure misclassification. The causality between cannabis usage and increased anesthetic dosing could not be established due to the observational nature of this study. 

DISCLOSURES:

This study was supported by the National Institute on Aging, the National Institutes of Health, and in part by the University of Florida Clinical and Translational Science Institute. Some authors declared receiving research support, consulting fees, and honoraria and having other ties with pharmaceutical companies and various other sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE: 

Cannabis users aged 65 years or older undergoing general anesthesia for surgery required higher doses of inhalational anesthetics than nonusers. However, the clinical relevance of this difference remains unclear.

METHODOLOGY:

  • To assess if cannabis use leads to higher doses of inhalational anesthesia during surgery, the researchers conducted a retrospective cohort study comparing the average intraoperative minimum alveolar concentrations of volatile anesthetics (isoflurane and sevoflurane) between older adults who used cannabis products and those who did not.
  • The researchers reviewed electronic health records of 22,476 patients aged 65 years or older who underwent surgery at the University of Florida Health System between 2018 and 2020.
  • Overall, 268 patients who reported using cannabis within 60 days of surgery (median age, 69 years; 35% women) were matched to 1072 nonusers.
  • The median duration of anesthesia was 175 minutes.
  • The primary outcome was the intraoperative time-weighted average of isoflurane or sevoflurane minimum alveolar concentration equivalents.

TAKEAWAY:

  • Cannabis users had significantly higher average minimum alveolar concentrations of isoflurane or sevoflurane than nonusers (mean, 0.58 vs 0.54; mean difference, 0.04; P = .021).
  • The findings were confirmed in a sensitivity analysis that revealed higher mean average minimum alveolar concentrations of anesthesia in cannabis users than in nonusers (0.57 vs 0.53; P = .029).
  • Although the 0.04 difference in minimum alveolar concentration between cannabis users and nonusers was statistically significant, its clinical importance is unclear.

IN PRACTICE:

“While recent guidelines underscore the importance of universal screening for cannabinoids before surgery, caution is paramount to prevent clinical bias leading to the administration of unnecessary higher doses of inhalational anesthesia, especially as robust evidence supporting such practices remains lacking,” the authors of the study wrote.
 

SOURCE:

This study was led by Ruba Sajdeya, MD, PhD, of the Department of Epidemiology at the University of Florida, Gainesville, and was published online in August 2024 in Anesthesiology.

LIMITATIONS: 

This study lacked access to prescription or dispensed medications, including opioids, which may have introduced residual confounding. Potential underdocumentation of cannabis use in medical records could have led to exposure misclassification. The causality between cannabis usage and increased anesthetic dosing could not be established due to the observational nature of this study. 

DISCLOSURES:

This study was supported by the National Institute on Aging, the National Institutes of Health, and in part by the University of Florida Clinical and Translational Science Institute. Some authors declared receiving research support, consulting fees, and honoraria and having other ties with pharmaceutical companies and various other sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE: 

Cannabis users aged 65 years or older undergoing general anesthesia for surgery required higher doses of inhalational anesthetics than nonusers. However, the clinical relevance of this difference remains unclear.

METHODOLOGY:

  • To assess if cannabis use leads to higher doses of inhalational anesthesia during surgery, the researchers conducted a retrospective cohort study comparing the average intraoperative minimum alveolar concentrations of volatile anesthetics (isoflurane and sevoflurane) between older adults who used cannabis products and those who did not.
  • The researchers reviewed electronic health records of 22,476 patients aged 65 years or older who underwent surgery at the University of Florida Health System between 2018 and 2020.
  • Overall, 268 patients who reported using cannabis within 60 days of surgery (median age, 69 years; 35% women) were matched to 1072 nonusers.
  • The median duration of anesthesia was 175 minutes.
  • The primary outcome was the intraoperative time-weighted average of isoflurane or sevoflurane minimum alveolar concentration equivalents.

TAKEAWAY:

  • Cannabis users had significantly higher average minimum alveolar concentrations of isoflurane or sevoflurane than nonusers (mean, 0.58 vs 0.54; mean difference, 0.04; P = .021).
  • The findings were confirmed in a sensitivity analysis that revealed higher mean average minimum alveolar concentrations of anesthesia in cannabis users than in nonusers (0.57 vs 0.53; P = .029).
  • Although the 0.04 difference in minimum alveolar concentration between cannabis users and nonusers was statistically significant, its clinical importance is unclear.

IN PRACTICE:

“While recent guidelines underscore the importance of universal screening for cannabinoids before surgery, caution is paramount to prevent clinical bias leading to the administration of unnecessary higher doses of inhalational anesthesia, especially as robust evidence supporting such practices remains lacking,” the authors of the study wrote.
 

SOURCE:

This study was led by Ruba Sajdeya, MD, PhD, of the Department of Epidemiology at the University of Florida, Gainesville, and was published online in August 2024 in Anesthesiology.

LIMITATIONS: 

This study lacked access to prescription or dispensed medications, including opioids, which may have introduced residual confounding. Potential underdocumentation of cannabis use in medical records could have led to exposure misclassification. The causality between cannabis usage and increased anesthetic dosing could not be established due to the observational nature of this study. 

DISCLOSURES:

This study was supported by the National Institute on Aging, the National Institutes of Health, and in part by the University of Florida Clinical and Translational Science Institute. Some authors declared receiving research support, consulting fees, and honoraria and having other ties with pharmaceutical companies and various other sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Why More Doctors Are Joining Unions

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Changed
Tue, 09/10/2024 - 12:16

 

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

 

 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

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With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

 

 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

 

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

 

 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

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Acne: Positive Outcomes Described With Laser Treatment

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Tue, 09/10/2024 - 12:17

 

After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

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After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

 

After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

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Topical Tapinarof and Roflumilast for Psoriasis: Where Do they Fit In?

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Tue, 09/10/2024 - 11:51

 

. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

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. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

 

. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

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Topical Treatment Provides a Noninvasive Option for Pyogenic Granuloma in Children

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Tue, 09/10/2024 - 11:24

 

— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

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— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

 

— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

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