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Study Detects Bacteria in Tattoo, Permanent Makeup Inks

Article Type
Changed
Mon, 08/12/2024 - 13:17

Commercial tattoo and permanent makeup inks are too often contaminated with microbes that can lead to infection, warn investigators of a first-of-its-kind study testing the products. 

When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.

Venerala/gettyimages


They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.

“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release. 

The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.

New Body Art Culture

Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.

This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.

Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains. 

Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.

Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria. 

There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.

“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.

The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.

The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.

Counseling Patients

Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.

Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization. 

Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.

“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.” 

Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.

The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.

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

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Commercial tattoo and permanent makeup inks are too often contaminated with microbes that can lead to infection, warn investigators of a first-of-its-kind study testing the products. 

When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.

Venerala/gettyimages


They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.

“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release. 

The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.

New Body Art Culture

Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.

This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.

Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains. 

Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.

Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria. 

There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.

“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.

The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.

The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.

Counseling Patients

Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.

Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization. 

Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.

“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.” 

Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.

The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.

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

Commercial tattoo and permanent makeup inks are too often contaminated with microbes that can lead to infection, warn investigators of a first-of-its-kind study testing the products. 

When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.

Venerala/gettyimages


They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.

“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release. 

The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.

New Body Art Culture

Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.

This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.

Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains. 

Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.

Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria. 

There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.

“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.

The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.

The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.

Counseling Patients

Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.

Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization. 

Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.

“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.” 

Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.

The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.

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

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In Some Patients, Antiseizure Medications Can Cause Severe Skin Reactions

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Changed
Thu, 07/18/2024 - 10:53

Avoiding severe skin reactions to antiseizure medications (ASMs) requires assessing patient risk factors and prescribing lower-risk drugs wherever possible, according to authors of a recent review. And if putting higher-risk patients on drugs most associated with human leukocyte antigen (HLA)–related reaction risk before test results are available, authors advised starting at low doses and titrating slowly.

“When someone is having a seizure drug prescribed,” said senior author Ram Mani, MD, MSCE, chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, “it’s often a tense clinical situation because the patient has either had the first few seizures of their life, or they’ve had a worsening in their seizures.”

courtesy Rutgers Robert Wood Johnson Medical School
Dr. Ram Mani

To help physicians optimize choices, Dr. Mani and colleagues reviewed literature regarding 31 ASMs. Their study was published in Current Treatment Options in Neurology.

Overall, said Dr. Mani, incidence of benign skin reactions such as morbilliform exanthematous eruptions, which account for 95% of cutaneous adverse drug reactions (CADRs), ranges from a few percent up to 15%. “It’s a somewhat common occurrence. Fortunately, the reactions that can lead to morbidity and mortality are fairly rare.”
 

Severe Cutaneous Adverse Reactions

Among the five ASMs approved by the Food and Drug Administration since 2018, cenobamate has sparked the greatest concern. In early clinical development for epilepsy, a fast titration schedule (starting at 50 mg/day and increasing by 50 mg every 2 weeks to at least 200 mg/day) resulted in three cases of drug reaction with eosinophilia and systemic symptoms (DRESS, also called drug-induced hypersensitivity reaction/DIHS), including one fatal case. Based on a phase 3 trial, the drug’s manufacturer now recommends starting at 12.5 mg and titrating more slowly.

DRESS/DIHS appears within 2-6 weeks of drug exposure. Along with malaise, fever, and conjunctivitis, symptoms can include skin eruptions ranging from morbilliform to hemorrhagic and bullous. “Facial edema and early facial rash are classic findings,” the authors added. DRESS also can involve painful lymphadenopathy and potentially life-threatening damage to the liver, heart, and other organs.

Stevens-Johnson syndrome (SJS), which is characterized by detached skin measuring less than 10% of the entire body surface area, typically happens within the first month of drug exposure. Flu-like symptoms can appear 1-3 days before erythematous to dusky macules, commonly on the chest, as well as cutaneous and mucosal erosions. Along with the skin and conjunctiva, SJS can affect the eyes, lungs, liver, bone marrow, and gastrointestinal tract.

When patients present with possible DRESS or SJS, the authors recommended inpatient multidisciplinary care. Having ready access to blood tests can help assess severity and prognosis, Dr. Mani explained. Inpatient evaluation and treatment also may allow faster access to other specialists as needed, and monitoring of potential seizure exacerbation in patients with uncontrolled seizures for whom the drug provided benefit but required abrupt discontinuation.

Often, he added, all hope is not lost for future use of the medication after a minor skin reaction. A case series and literature review of mild lamotrigine-associated CADRs showed that most patients could reintroduce and titrate lamotrigine by waiting at least 4 weeks, beginning at 5 mg/day, and gradually increasing to 25 mg/day.
 

 

 

Identifying Those at Risk

With millions of patients being newly prescribed ASMs annually, accurately screening out all people at risk of severe cutaneous adverse reactions based on available genetic information is impossible. The complexity of evolving recommendations for HLA testing makes them hard to remember, Dr. Mani said. “Development and better use of clinical decision support systems can help.”

Accordingly, he starts with a thorough history and physical examination, inquiring about prior skin reactions or hypersensitivity, which are risk factors for future reactions to drugs such as carbamazepine, phenytoin, phenobarbital, oxcarbazepine, lamotrigine, rufinamide, and zonisamide. “Most of the medicines that the HLA tests are being done for are not the initial medicines I typically prescribe for a patient with newly diagnosed epilepsy,” said Dr. Mani. For ASM-naive patients with moderate or high risk of skin hypersensitivity reactions, he usually starts with lacosamide, levetiracetam, or brivaracetam. Additional low-risk drugs he considers in more complex cases include valproate, topiramate, and clobazam.

Only if a patient’s initial ASM causes problems will Dr. Mani consider higher-risk options and order HLA tests for patients belonging to indicated groups — such as testing for HLA-B*15:02 in Asian patients being considered for carbamazepine. About once weekly, he must put a patient on a potentially higher-risk drug before test results are available. If after a thorough risk-benefit discussion, he and the patient agree that the higher-risk drug is warranted, Dr. Mani starts at a lower-than-labeled dose, with a slower titration schedule that typically extends the ramp-up period by 1 week.

Fortunately, Dr. Mani said that, in 20 years of practice, he has seen more misdiagnoses — involving rashes from poison ivy, viral infections, or allergies — than actual ASM-induced reactions. “That’s why the patient, family, and practitioner need to be open-minded about what could be causing the rash.”

Dr. Mani reported no relevant conflicts. The study authors reported no funding sources.

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Avoiding severe skin reactions to antiseizure medications (ASMs) requires assessing patient risk factors and prescribing lower-risk drugs wherever possible, according to authors of a recent review. And if putting higher-risk patients on drugs most associated with human leukocyte antigen (HLA)–related reaction risk before test results are available, authors advised starting at low doses and titrating slowly.

“When someone is having a seizure drug prescribed,” said senior author Ram Mani, MD, MSCE, chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, “it’s often a tense clinical situation because the patient has either had the first few seizures of their life, or they’ve had a worsening in their seizures.”

courtesy Rutgers Robert Wood Johnson Medical School
Dr. Ram Mani

To help physicians optimize choices, Dr. Mani and colleagues reviewed literature regarding 31 ASMs. Their study was published in Current Treatment Options in Neurology.

Overall, said Dr. Mani, incidence of benign skin reactions such as morbilliform exanthematous eruptions, which account for 95% of cutaneous adverse drug reactions (CADRs), ranges from a few percent up to 15%. “It’s a somewhat common occurrence. Fortunately, the reactions that can lead to morbidity and mortality are fairly rare.”
 

Severe Cutaneous Adverse Reactions

Among the five ASMs approved by the Food and Drug Administration since 2018, cenobamate has sparked the greatest concern. In early clinical development for epilepsy, a fast titration schedule (starting at 50 mg/day and increasing by 50 mg every 2 weeks to at least 200 mg/day) resulted in three cases of drug reaction with eosinophilia and systemic symptoms (DRESS, also called drug-induced hypersensitivity reaction/DIHS), including one fatal case. Based on a phase 3 trial, the drug’s manufacturer now recommends starting at 12.5 mg and titrating more slowly.

DRESS/DIHS appears within 2-6 weeks of drug exposure. Along with malaise, fever, and conjunctivitis, symptoms can include skin eruptions ranging from morbilliform to hemorrhagic and bullous. “Facial edema and early facial rash are classic findings,” the authors added. DRESS also can involve painful lymphadenopathy and potentially life-threatening damage to the liver, heart, and other organs.

Stevens-Johnson syndrome (SJS), which is characterized by detached skin measuring less than 10% of the entire body surface area, typically happens within the first month of drug exposure. Flu-like symptoms can appear 1-3 days before erythematous to dusky macules, commonly on the chest, as well as cutaneous and mucosal erosions. Along with the skin and conjunctiva, SJS can affect the eyes, lungs, liver, bone marrow, and gastrointestinal tract.

When patients present with possible DRESS or SJS, the authors recommended inpatient multidisciplinary care. Having ready access to blood tests can help assess severity and prognosis, Dr. Mani explained. Inpatient evaluation and treatment also may allow faster access to other specialists as needed, and monitoring of potential seizure exacerbation in patients with uncontrolled seizures for whom the drug provided benefit but required abrupt discontinuation.

Often, he added, all hope is not lost for future use of the medication after a minor skin reaction. A case series and literature review of mild lamotrigine-associated CADRs showed that most patients could reintroduce and titrate lamotrigine by waiting at least 4 weeks, beginning at 5 mg/day, and gradually increasing to 25 mg/day.
 

 

 

Identifying Those at Risk

With millions of patients being newly prescribed ASMs annually, accurately screening out all people at risk of severe cutaneous adverse reactions based on available genetic information is impossible. The complexity of evolving recommendations for HLA testing makes them hard to remember, Dr. Mani said. “Development and better use of clinical decision support systems can help.”

Accordingly, he starts with a thorough history and physical examination, inquiring about prior skin reactions or hypersensitivity, which are risk factors for future reactions to drugs such as carbamazepine, phenytoin, phenobarbital, oxcarbazepine, lamotrigine, rufinamide, and zonisamide. “Most of the medicines that the HLA tests are being done for are not the initial medicines I typically prescribe for a patient with newly diagnosed epilepsy,” said Dr. Mani. For ASM-naive patients with moderate or high risk of skin hypersensitivity reactions, he usually starts with lacosamide, levetiracetam, or brivaracetam. Additional low-risk drugs he considers in more complex cases include valproate, topiramate, and clobazam.

Only if a patient’s initial ASM causes problems will Dr. Mani consider higher-risk options and order HLA tests for patients belonging to indicated groups — such as testing for HLA-B*15:02 in Asian patients being considered for carbamazepine. About once weekly, he must put a patient on a potentially higher-risk drug before test results are available. If after a thorough risk-benefit discussion, he and the patient agree that the higher-risk drug is warranted, Dr. Mani starts at a lower-than-labeled dose, with a slower titration schedule that typically extends the ramp-up period by 1 week.

Fortunately, Dr. Mani said that, in 20 years of practice, he has seen more misdiagnoses — involving rashes from poison ivy, viral infections, or allergies — than actual ASM-induced reactions. “That’s why the patient, family, and practitioner need to be open-minded about what could be causing the rash.”

Dr. Mani reported no relevant conflicts. The study authors reported no funding sources.

Avoiding severe skin reactions to antiseizure medications (ASMs) requires assessing patient risk factors and prescribing lower-risk drugs wherever possible, according to authors of a recent review. And if putting higher-risk patients on drugs most associated with human leukocyte antigen (HLA)–related reaction risk before test results are available, authors advised starting at low doses and titrating slowly.

“When someone is having a seizure drug prescribed,” said senior author Ram Mani, MD, MSCE, chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, “it’s often a tense clinical situation because the patient has either had the first few seizures of their life, or they’ve had a worsening in their seizures.”

courtesy Rutgers Robert Wood Johnson Medical School
Dr. Ram Mani

To help physicians optimize choices, Dr. Mani and colleagues reviewed literature regarding 31 ASMs. Their study was published in Current Treatment Options in Neurology.

Overall, said Dr. Mani, incidence of benign skin reactions such as morbilliform exanthematous eruptions, which account for 95% of cutaneous adverse drug reactions (CADRs), ranges from a few percent up to 15%. “It’s a somewhat common occurrence. Fortunately, the reactions that can lead to morbidity and mortality are fairly rare.”
 

Severe Cutaneous Adverse Reactions

Among the five ASMs approved by the Food and Drug Administration since 2018, cenobamate has sparked the greatest concern. In early clinical development for epilepsy, a fast titration schedule (starting at 50 mg/day and increasing by 50 mg every 2 weeks to at least 200 mg/day) resulted in three cases of drug reaction with eosinophilia and systemic symptoms (DRESS, also called drug-induced hypersensitivity reaction/DIHS), including one fatal case. Based on a phase 3 trial, the drug’s manufacturer now recommends starting at 12.5 mg and titrating more slowly.

DRESS/DIHS appears within 2-6 weeks of drug exposure. Along with malaise, fever, and conjunctivitis, symptoms can include skin eruptions ranging from morbilliform to hemorrhagic and bullous. “Facial edema and early facial rash are classic findings,” the authors added. DRESS also can involve painful lymphadenopathy and potentially life-threatening damage to the liver, heart, and other organs.

Stevens-Johnson syndrome (SJS), which is characterized by detached skin measuring less than 10% of the entire body surface area, typically happens within the first month of drug exposure. Flu-like symptoms can appear 1-3 days before erythematous to dusky macules, commonly on the chest, as well as cutaneous and mucosal erosions. Along with the skin and conjunctiva, SJS can affect the eyes, lungs, liver, bone marrow, and gastrointestinal tract.

When patients present with possible DRESS or SJS, the authors recommended inpatient multidisciplinary care. Having ready access to blood tests can help assess severity and prognosis, Dr. Mani explained. Inpatient evaluation and treatment also may allow faster access to other specialists as needed, and monitoring of potential seizure exacerbation in patients with uncontrolled seizures for whom the drug provided benefit but required abrupt discontinuation.

Often, he added, all hope is not lost for future use of the medication after a minor skin reaction. A case series and literature review of mild lamotrigine-associated CADRs showed that most patients could reintroduce and titrate lamotrigine by waiting at least 4 weeks, beginning at 5 mg/day, and gradually increasing to 25 mg/day.
 

 

 

Identifying Those at Risk

With millions of patients being newly prescribed ASMs annually, accurately screening out all people at risk of severe cutaneous adverse reactions based on available genetic information is impossible. The complexity of evolving recommendations for HLA testing makes them hard to remember, Dr. Mani said. “Development and better use of clinical decision support systems can help.”

Accordingly, he starts with a thorough history and physical examination, inquiring about prior skin reactions or hypersensitivity, which are risk factors for future reactions to drugs such as carbamazepine, phenytoin, phenobarbital, oxcarbazepine, lamotrigine, rufinamide, and zonisamide. “Most of the medicines that the HLA tests are being done for are not the initial medicines I typically prescribe for a patient with newly diagnosed epilepsy,” said Dr. Mani. For ASM-naive patients with moderate or high risk of skin hypersensitivity reactions, he usually starts with lacosamide, levetiracetam, or brivaracetam. Additional low-risk drugs he considers in more complex cases include valproate, topiramate, and clobazam.

Only if a patient’s initial ASM causes problems will Dr. Mani consider higher-risk options and order HLA tests for patients belonging to indicated groups — such as testing for HLA-B*15:02 in Asian patients being considered for carbamazepine. About once weekly, he must put a patient on a potentially higher-risk drug before test results are available. If after a thorough risk-benefit discussion, he and the patient agree that the higher-risk drug is warranted, Dr. Mani starts at a lower-than-labeled dose, with a slower titration schedule that typically extends the ramp-up period by 1 week.

Fortunately, Dr. Mani said that, in 20 years of practice, he has seen more misdiagnoses — involving rashes from poison ivy, viral infections, or allergies — than actual ASM-induced reactions. “That’s why the patient, family, and practitioner need to be open-minded about what could be causing the rash.”

Dr. Mani reported no relevant conflicts. The study authors reported no funding sources.

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‘Emerging Threat’ Xylazine Use Continues to Spread Across the United States

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Wed, 09/04/2024 - 10:19

 

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

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Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

 

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

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Revamping Resident Schedules to Reduce Burnout

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Wed, 07/17/2024 - 12:34

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

 

 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

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It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

 

 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

 

 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

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Study Finds Potential benefits of Spironolactone for Women with HS

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Wed, 07/17/2024 - 09:56

 

TOPLINE: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

  • This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
  • The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
  • Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

  • Overall, 31 patients (20%) showed improvements with spironolactone treatment.
  • A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
  • Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
  • Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest. 

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: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

  • This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
  • The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
  • Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

  • Overall, 31 patients (20%) showed improvements with spironolactone treatment.
  • A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
  • Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
  • Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest. 

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: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

  • This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
  • The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
  • Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

  • Overall, 31 patients (20%) showed improvements with spironolactone treatment.
  • A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
  • Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
  • Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest. 

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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Studies Show Dupilumab Effects In Children with Both Atopic Dermatitis and Alopecia

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Changed
Wed, 07/17/2024 - 09:57

 

TOPLINE:

Dupilumab treatment significantly improved both hair regrowth and the severity of atopic dermatitis (AD) in pediatric patients who also had alopecia areata (AA) in a review. 

METHODOLOGY:

  • Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
  • The review included four case reports, two case series, and one retrospective chart review.
  • Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
  • The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).

TAKEAWAY:

  • Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
  • Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
  • There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
  • Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.

IN PRACTICE:

“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.” 

SOURCE:

The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology

LIMITATIONS:

Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.

DISCLOSURES:

The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
 

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:

Dupilumab treatment significantly improved both hair regrowth and the severity of atopic dermatitis (AD) in pediatric patients who also had alopecia areata (AA) in a review. 

METHODOLOGY:

  • Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
  • The review included four case reports, two case series, and one retrospective chart review.
  • Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
  • The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).

TAKEAWAY:

  • Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
  • Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
  • There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
  • Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.

IN PRACTICE:

“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.” 

SOURCE:

The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology

LIMITATIONS:

Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.

DISCLOSURES:

The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
 

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:

Dupilumab treatment significantly improved both hair regrowth and the severity of atopic dermatitis (AD) in pediatric patients who also had alopecia areata (AA) in a review. 

METHODOLOGY:

  • Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
  • The review included four case reports, two case series, and one retrospective chart review.
  • Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
  • The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).

TAKEAWAY:

  • Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
  • Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
  • There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
  • Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.

IN PRACTICE:

“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.” 

SOURCE:

The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology

LIMITATIONS:

Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.

DISCLOSURES:

The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
 

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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Study Estimates Global Prevalence of Seborrheic Dermatitis

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Wed, 07/17/2024 - 10:52

 

TOPLINE:

Seborrheic dermatitis affects an estimated 4% of the global population, with significant variations across age groups, settings, and regions, according to a meta-analysis that also found a higher prevalence in adults than in children.

METHODOLOGY:

  • Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
  • The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
  • The primary outcome was the pooled prevalence of seborrheic dermatitis.

TAKEAWAY:

  • The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
  • The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
  • A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.

IN PRACTICE:

The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.

SOURCE:

The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.

LIMITATIONS:

Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.

DISCLOSURES:

Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.

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:

Seborrheic dermatitis affects an estimated 4% of the global population, with significant variations across age groups, settings, and regions, according to a meta-analysis that also found a higher prevalence in adults than in children.

METHODOLOGY:

  • Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
  • The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
  • The primary outcome was the pooled prevalence of seborrheic dermatitis.

TAKEAWAY:

  • The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
  • The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
  • A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.

IN PRACTICE:

The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.

SOURCE:

The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.

LIMITATIONS:

Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.

DISCLOSURES:

Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.

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:

Seborrheic dermatitis affects an estimated 4% of the global population, with significant variations across age groups, settings, and regions, according to a meta-analysis that also found a higher prevalence in adults than in children.

METHODOLOGY:

  • Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
  • The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
  • The primary outcome was the pooled prevalence of seborrheic dermatitis.

TAKEAWAY:

  • The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
  • The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
  • A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.

IN PRACTICE:

The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.

SOURCE:

The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.

LIMITATIONS:

Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.

DISCLOSURES:

Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.

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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How Common Are Life-Threatening Infections In Infants with Pustules, Vesicles?

Article Type
Changed
Wed, 07/17/2024 - 09:37

 

TOPLINE:

Full-term afebrile infants with pustules and vesicles have a low likelihood of life-threatening infections once herpes simplex virus (HSV) is ruled out, according to the findings from a retrospective study.

METHODOLOGY:

  • Researchers reviewed the electronic medical records of infants aged ≤ 60 days who received a pediatric dermatology consultation at six US academic institutions between September 2013 and August 2019.
  • Among 879 consults, 183 afebrile infants were identified as having presented with pustules, vesicles, and/or bullae.
  • Infectious disease workups included blood cultures, urine cultures, lumbar punctures, and HSV testing using viral skin culture, direct immunofluorescence assay, and/or polymerase chain reaction.
  • Patients were categorized by gestational age as preterm (< 37 weeks), full-term (37-42 weeks), and post-term (≥ 42 weeks).
  • Overall, 67.8% of infants had pustules, 31.1% had vesicles, and 10.4% had bullae.

TAKEAWAY:

  • None of the cases showed positive cerebrospinal fluid or pathogenic blood cultures. In 122 of the cases (66.6%), a noninfectious cause was diagnosed, and an infectious cause was diagnosed in 71 cases (38.8%; some patients had more than one diagnosis).
  • Of the 127 newborns evaluated for HSV infection, nine (7.1%) tested positive, of whom seven (5.5%) had disease affecting the skin, eye, and mouth and were full- term infants, and two (1.6%) had disseminated HSV and were preterm infants.
  • Angioinvasive fungal infection was diagnosed in five infants (2.7%), all of whom were preterm infants (< 28 weeks gestational age).
  • The risk for life-threatening disease was higher in preterm infants born before 32 weeks of gestational age (P < .01) compared with those born after 32 weeks.

IN PRACTICE:

“Full-term, well-appearing, afebrile infants ≤ 60 days of age presenting with pustules or vesicles may not require full SBI [serious bacterial infection] work-up, although larger studies are needed,” the authors concluded. Testing for HSV, they added, “is recommended in all infants with vesicles, grouped pustules, or pustules accompanied by punched out or grouped erosions,” and preterm infants “should be assessed for disseminated fungal infection and HSV in the setting of fluid-filled skin lesions.”

SOURCE:

The study was led by Sonora Yun, BA, Columbia University, New York City, and was published online in Pediatrics.

LIMITATIONS:

The data were limited by the sample size and very low incidence of serious infections. Infants probably had atypical or severe presentations that warranted pediatric dermatology consultation, which may have led to overrepresentation of infectious disease rates. The study inclusion was restricted to those who received a dermatology consult; therefore, the findings may not be generalizable to outpatient primary care.

DISCLOSURES:

This study did not receive any external funding. The authors declared that they had no relevant conflicts of interest.

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:

Full-term afebrile infants with pustules and vesicles have a low likelihood of life-threatening infections once herpes simplex virus (HSV) is ruled out, according to the findings from a retrospective study.

METHODOLOGY:

  • Researchers reviewed the electronic medical records of infants aged ≤ 60 days who received a pediatric dermatology consultation at six US academic institutions between September 2013 and August 2019.
  • Among 879 consults, 183 afebrile infants were identified as having presented with pustules, vesicles, and/or bullae.
  • Infectious disease workups included blood cultures, urine cultures, lumbar punctures, and HSV testing using viral skin culture, direct immunofluorescence assay, and/or polymerase chain reaction.
  • Patients were categorized by gestational age as preterm (< 37 weeks), full-term (37-42 weeks), and post-term (≥ 42 weeks).
  • Overall, 67.8% of infants had pustules, 31.1% had vesicles, and 10.4% had bullae.

TAKEAWAY:

  • None of the cases showed positive cerebrospinal fluid or pathogenic blood cultures. In 122 of the cases (66.6%), a noninfectious cause was diagnosed, and an infectious cause was diagnosed in 71 cases (38.8%; some patients had more than one diagnosis).
  • Of the 127 newborns evaluated for HSV infection, nine (7.1%) tested positive, of whom seven (5.5%) had disease affecting the skin, eye, and mouth and were full- term infants, and two (1.6%) had disseminated HSV and were preterm infants.
  • Angioinvasive fungal infection was diagnosed in five infants (2.7%), all of whom were preterm infants (< 28 weeks gestational age).
  • The risk for life-threatening disease was higher in preterm infants born before 32 weeks of gestational age (P < .01) compared with those born after 32 weeks.

IN PRACTICE:

“Full-term, well-appearing, afebrile infants ≤ 60 days of age presenting with pustules or vesicles may not require full SBI [serious bacterial infection] work-up, although larger studies are needed,” the authors concluded. Testing for HSV, they added, “is recommended in all infants with vesicles, grouped pustules, or pustules accompanied by punched out or grouped erosions,” and preterm infants “should be assessed for disseminated fungal infection and HSV in the setting of fluid-filled skin lesions.”

SOURCE:

The study was led by Sonora Yun, BA, Columbia University, New York City, and was published online in Pediatrics.

LIMITATIONS:

The data were limited by the sample size and very low incidence of serious infections. Infants probably had atypical or severe presentations that warranted pediatric dermatology consultation, which may have led to overrepresentation of infectious disease rates. The study inclusion was restricted to those who received a dermatology consult; therefore, the findings may not be generalizable to outpatient primary care.

DISCLOSURES:

This study did not receive any external funding. The authors declared that they had no relevant conflicts of interest.

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:

Full-term afebrile infants with pustules and vesicles have a low likelihood of life-threatening infections once herpes simplex virus (HSV) is ruled out, according to the findings from a retrospective study.

METHODOLOGY:

  • Researchers reviewed the electronic medical records of infants aged ≤ 60 days who received a pediatric dermatology consultation at six US academic institutions between September 2013 and August 2019.
  • Among 879 consults, 183 afebrile infants were identified as having presented with pustules, vesicles, and/or bullae.
  • Infectious disease workups included blood cultures, urine cultures, lumbar punctures, and HSV testing using viral skin culture, direct immunofluorescence assay, and/or polymerase chain reaction.
  • Patients were categorized by gestational age as preterm (< 37 weeks), full-term (37-42 weeks), and post-term (≥ 42 weeks).
  • Overall, 67.8% of infants had pustules, 31.1% had vesicles, and 10.4% had bullae.

TAKEAWAY:

  • None of the cases showed positive cerebrospinal fluid or pathogenic blood cultures. In 122 of the cases (66.6%), a noninfectious cause was diagnosed, and an infectious cause was diagnosed in 71 cases (38.8%; some patients had more than one diagnosis).
  • Of the 127 newborns evaluated for HSV infection, nine (7.1%) tested positive, of whom seven (5.5%) had disease affecting the skin, eye, and mouth and were full- term infants, and two (1.6%) had disseminated HSV and were preterm infants.
  • Angioinvasive fungal infection was diagnosed in five infants (2.7%), all of whom were preterm infants (< 28 weeks gestational age).
  • The risk for life-threatening disease was higher in preterm infants born before 32 weeks of gestational age (P < .01) compared with those born after 32 weeks.

IN PRACTICE:

“Full-term, well-appearing, afebrile infants ≤ 60 days of age presenting with pustules or vesicles may not require full SBI [serious bacterial infection] work-up, although larger studies are needed,” the authors concluded. Testing for HSV, they added, “is recommended in all infants with vesicles, grouped pustules, or pustules accompanied by punched out or grouped erosions,” and preterm infants “should be assessed for disseminated fungal infection and HSV in the setting of fluid-filled skin lesions.”

SOURCE:

The study was led by Sonora Yun, BA, Columbia University, New York City, and was published online in Pediatrics.

LIMITATIONS:

The data were limited by the sample size and very low incidence of serious infections. Infants probably had atypical or severe presentations that warranted pediatric dermatology consultation, which may have led to overrepresentation of infectious disease rates. The study inclusion was restricted to those who received a dermatology consult; therefore, the findings may not be generalizable to outpatient primary care.

DISCLOSURES:

This study did not receive any external funding. The authors declared that they had no relevant conflicts of interest.

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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Topical PDE4 Inhibitor Now Approved for Atopic Dermatitis in Children, Adults

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Wed, 07/17/2024 - 09:11

On July 9, the Food and Drug Administration approved the supplemental new drug application for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and in pediatric patients aged 6 years or older.

Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase-4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.

According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P < .0001; INTEGUMENT-2: 39% vs 16.9%; P < .0001), with significant improvement as early as week 1 (P < .0001).



Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved a 75% reduction in their Eczema Area and Severity Index scores, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older. 

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

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On July 9, the Food and Drug Administration approved the supplemental new drug application for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and in pediatric patients aged 6 years or older.

Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase-4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.

According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P < .0001; INTEGUMENT-2: 39% vs 16.9%; P < .0001), with significant improvement as early as week 1 (P < .0001).



Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved a 75% reduction in their Eczema Area and Severity Index scores, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older. 

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

On July 9, the Food and Drug Administration approved the supplemental new drug application for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and in pediatric patients aged 6 years or older.

Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase-4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.

According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P < .0001; INTEGUMENT-2: 39% vs 16.9%; P < .0001), with significant improvement as early as week 1 (P < .0001).



Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved a 75% reduction in their Eczema Area and Severity Index scores, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older. 

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

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Uproar Over Vitamin D Disease-Prevention Guideline

Article Type
Changed
Mon, 07/15/2024 - 16:12

A recent report by this news organization of a vitamin D clinical practice guideline released by the Endocrine Society in June triggered an outpouring of objections in the comments section from doctors and other readers.

A society press release listed the key new recommendations on the use of vitamin D supplementation and screening to reduce disease risks in individuals without established indications for such treatment or testing:

  • For healthy adults younger than 75, no supplementation at doses above the recommended dietary intakes.
  • Populations that may benefit from higher doses include: children and adolescents 18 and younger to prevent rickets and to reduce risk for respiratory infection, individuals 75 and older to possibly lower mortality risk, “pregnant people” to potentially reduce various risks, and people with prediabetes to potentially reduce risk of progression.
  • No routine testing for 25-hydroxyvitamin D levels because outcome-specific benefits based on those levels have not been identified (including screening in people with dark complexion or obesity).
  • Based on insufficient evidence, the panel could not determine specific blood-level thresholds for 25-hydroxyvitamin D for adequacy or for target levels for disease prevention.

This news organization covered the guideline release and simultaneous presentation at the Endocrine Society annual meeting. In response to the coverage, more than 200 doctors and other readers expressed concerns about the guideline, and some said outright that they would not follow it (readers quoted below are identified by the usernames they registered with on the website).

One reader who posted as Dr. Joseph Destefano went so far as to call the guideline “dangerous” and “almost ... evil.” Ironically, some readers attacked this news organization, thinking that the coverage implied an endorsement, rather than a news report.
 

Ignores Potential Benefits

Although the guideline is said to be for people who are “otherwise healthy” (other than the exceptions noted above), many readers were concerned that the recommendations ignore the potential benefits of supplementation for other health conditions relevant to patients and other populations.

“They address issues dealing only with endocrinology and bone health for the most part,” Dr. Emilio Gonzalez wrote. “However, vitamin D insufficiency and deficiency are not rare, and they impact the treatment of autoimmune disorders, chronic pain control, immunosuppression, cancer prevention, cardiovascular health, etc. There is plenty of literature in this regard.”

“They make these claims as if quality studies contradicting their guidelines have not been out there for years,” Dr. Brian Batcheldor said. “What about the huge demographic with diseases that impact intestinal absorption, eg, Crohn’s and celiac disease, cystic fibrosis, and ulcerative colitis? What about the one in nine that now have autoimmune diseases still awaiting diagnosis? What about night workers or anyone with more restricted access to sun exposure? How about those whose cultural or religious dress code limit skin exposure?”

The latter group was also mentioned in a post from Dr. Eve Finkelstein who said, “They don’t take into account women who are totally covered for religious reasons. They have no skin other than part of their face exposed. It does not make sense not to supplement them. Ignoring women’s health needs seems to be the norm.”

“I don’t think they considered the oral health effects of vitamin D deficiency,” pointed out commenter Corie Lewis. “Excess dental calculus (tartar) from excess calcium/phosphate in saliva significantly increases an individual’s periodontal disease risks (gum disease), and low saliva calcium/phosphate increases dental caries (cavities) risks, which generally indicates an imbalance of the oral microbiome. Vitamin D can help create balance and reduce those oral health risks.”

Noted Kimberley Morris-Windisch, “Having worked in rheumatology and pain for most of my career, I have seen too many people benefit from correcting deficiency of vitamin D. To ignore this is to miss opportunities to improve patient health.” Furthermore, “I find it unlikely that it would only improve mortality after age 75. That makes no sense.”

“Also,” she added, “what is the number [needed] to harm? In my 25 years, I have seen vitamin D toxicity once and an excessively high level without symptoms one other time.”

“WHY? Just WHY?” lamented Anne Kinchen. “Low levels in pregnant women have long-term effects on the developing fetus — higher and earlier rates of osteopenia in female children, weaker immune systems overall. There are just SO many reasons to test. These guidelines for no testing are absurd!”
 

 

 

No Screening, No Need for Decision-Making?

Several readers questioned the society’s rationale for not screening, as expressed by session moderator Clifford J. Rosen, MD, director of Clinical and Translational Research and senior scientist at Maine Medical Center Research Institute, Scarborough, Maine.

“When clinicians measure vitamin D, then they’re forced to make a decision what to do about it,” Dr. Rosen said. “That’s where questions about the levels come in. And that’s a big problem. So what the panel’s saying is, don’t screen. ... This really gets to the heart of the issue, because we have no data that there’s anything about screening that allows us to improve quality of life. ... Screening is probably not worthwhile in any age group.”

Among the reader comments in this regard:

“So misguided. Don’t look because we don’t know what do to with data. That’s the message this article exposes. The recommendation is do nothing. But, doing nothing IS an action — not a default.” (Lisa Tracy)

“So now, you will not screen for vitamin D because you do not know what to do next? See a naturopathic doctor — we know what to do next!” (Dr. Joyce Roberson)

“Gee, how do we treat it? ... What to do? Sounds incompetent at minimum. I suspect it’s vital, easy, and inexpensive ... so hide it.” (Holly Kohley)

“Just because we do not know is not a rationale for not testing. The opposite should be done.” (Dr. JJ Gold)
 

Caters to Industry?

Many commentators intimated that pharma and/or insurance company considerations played a role in the recommendations. Their comments included the following:

“I have been under the impression people do routine checkups to verify there are no hidden problems. If only some testing is done, the probability of not finding a problem is huge. ... Preventive healthcare should be looking for something to prevent instead of waiting until they can cure it. Of course, it might come back to ‘follow the money.’ It is much more profitable to diagnose and treat than it is to prevent.” (Grace Kyser)

“The current irrational ‘recommendation’ gives insurance companies an excuse to deny ALL tests of vitamin D — even if the proper code is supplied. The result is — people suffer. This recommendation does harm!” (Dr JJ Gold)

“Essentially, they are saying let’s not screen ‘healthy’ individuals and ignore it altogether. Better to wait till they’re old, pregnant, or already sick and diagnosed with a disease. This is the problem with the healthcare in this country.” (Brittney Lesher)

“Until allopathic medicine stops waiting for severe symptoms to develop before even screening for potential health problems, the most expensive healthcare (aka, sick care) system in the world will continue to be content to focus on medical emergencies and ignore prevention. ...” (Dean Raffelock)

“Don’t test? Are you kidding me? Especially when people are supplementing? That is akin to taking a blood pressure medication without measuring blood pressures! ... Don’t test? Don’t supplement? ... I have only one explanation for such nonsense: Pharma lives off sick people, not healthy ones.” (Georg Schlomka)

On a somewhat conciliatory and pointed note, Dr Francesca Luna-Rudin commented, “I would like to remind all of my fellow physicians that recommendations should be regarded as just that, a ‘recommendation.’ As doctors, we can use guidelines and recommendations in our practice, but if a new one is presented that does not make sense or would lead to harm based on our education and training, then we are not bound to follow it!”

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

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A recent report by this news organization of a vitamin D clinical practice guideline released by the Endocrine Society in June triggered an outpouring of objections in the comments section from doctors and other readers.

A society press release listed the key new recommendations on the use of vitamin D supplementation and screening to reduce disease risks in individuals without established indications for such treatment or testing:

  • For healthy adults younger than 75, no supplementation at doses above the recommended dietary intakes.
  • Populations that may benefit from higher doses include: children and adolescents 18 and younger to prevent rickets and to reduce risk for respiratory infection, individuals 75 and older to possibly lower mortality risk, “pregnant people” to potentially reduce various risks, and people with prediabetes to potentially reduce risk of progression.
  • No routine testing for 25-hydroxyvitamin D levels because outcome-specific benefits based on those levels have not been identified (including screening in people with dark complexion or obesity).
  • Based on insufficient evidence, the panel could not determine specific blood-level thresholds for 25-hydroxyvitamin D for adequacy or for target levels for disease prevention.

This news organization covered the guideline release and simultaneous presentation at the Endocrine Society annual meeting. In response to the coverage, more than 200 doctors and other readers expressed concerns about the guideline, and some said outright that they would not follow it (readers quoted below are identified by the usernames they registered with on the website).

One reader who posted as Dr. Joseph Destefano went so far as to call the guideline “dangerous” and “almost ... evil.” Ironically, some readers attacked this news organization, thinking that the coverage implied an endorsement, rather than a news report.
 

Ignores Potential Benefits

Although the guideline is said to be for people who are “otherwise healthy” (other than the exceptions noted above), many readers were concerned that the recommendations ignore the potential benefits of supplementation for other health conditions relevant to patients and other populations.

“They address issues dealing only with endocrinology and bone health for the most part,” Dr. Emilio Gonzalez wrote. “However, vitamin D insufficiency and deficiency are not rare, and they impact the treatment of autoimmune disorders, chronic pain control, immunosuppression, cancer prevention, cardiovascular health, etc. There is plenty of literature in this regard.”

“They make these claims as if quality studies contradicting their guidelines have not been out there for years,” Dr. Brian Batcheldor said. “What about the huge demographic with diseases that impact intestinal absorption, eg, Crohn’s and celiac disease, cystic fibrosis, and ulcerative colitis? What about the one in nine that now have autoimmune diseases still awaiting diagnosis? What about night workers or anyone with more restricted access to sun exposure? How about those whose cultural or religious dress code limit skin exposure?”

The latter group was also mentioned in a post from Dr. Eve Finkelstein who said, “They don’t take into account women who are totally covered for religious reasons. They have no skin other than part of their face exposed. It does not make sense not to supplement them. Ignoring women’s health needs seems to be the norm.”

“I don’t think they considered the oral health effects of vitamin D deficiency,” pointed out commenter Corie Lewis. “Excess dental calculus (tartar) from excess calcium/phosphate in saliva significantly increases an individual’s periodontal disease risks (gum disease), and low saliva calcium/phosphate increases dental caries (cavities) risks, which generally indicates an imbalance of the oral microbiome. Vitamin D can help create balance and reduce those oral health risks.”

Noted Kimberley Morris-Windisch, “Having worked in rheumatology and pain for most of my career, I have seen too many people benefit from correcting deficiency of vitamin D. To ignore this is to miss opportunities to improve patient health.” Furthermore, “I find it unlikely that it would only improve mortality after age 75. That makes no sense.”

“Also,” she added, “what is the number [needed] to harm? In my 25 years, I have seen vitamin D toxicity once and an excessively high level without symptoms one other time.”

“WHY? Just WHY?” lamented Anne Kinchen. “Low levels in pregnant women have long-term effects on the developing fetus — higher and earlier rates of osteopenia in female children, weaker immune systems overall. There are just SO many reasons to test. These guidelines for no testing are absurd!”
 

 

 

No Screening, No Need for Decision-Making?

Several readers questioned the society’s rationale for not screening, as expressed by session moderator Clifford J. Rosen, MD, director of Clinical and Translational Research and senior scientist at Maine Medical Center Research Institute, Scarborough, Maine.

“When clinicians measure vitamin D, then they’re forced to make a decision what to do about it,” Dr. Rosen said. “That’s where questions about the levels come in. And that’s a big problem. So what the panel’s saying is, don’t screen. ... This really gets to the heart of the issue, because we have no data that there’s anything about screening that allows us to improve quality of life. ... Screening is probably not worthwhile in any age group.”

Among the reader comments in this regard:

“So misguided. Don’t look because we don’t know what do to with data. That’s the message this article exposes. The recommendation is do nothing. But, doing nothing IS an action — not a default.” (Lisa Tracy)

“So now, you will not screen for vitamin D because you do not know what to do next? See a naturopathic doctor — we know what to do next!” (Dr. Joyce Roberson)

“Gee, how do we treat it? ... What to do? Sounds incompetent at minimum. I suspect it’s vital, easy, and inexpensive ... so hide it.” (Holly Kohley)

“Just because we do not know is not a rationale for not testing. The opposite should be done.” (Dr. JJ Gold)
 

Caters to Industry?

Many commentators intimated that pharma and/or insurance company considerations played a role in the recommendations. Their comments included the following:

“I have been under the impression people do routine checkups to verify there are no hidden problems. If only some testing is done, the probability of not finding a problem is huge. ... Preventive healthcare should be looking for something to prevent instead of waiting until they can cure it. Of course, it might come back to ‘follow the money.’ It is much more profitable to diagnose and treat than it is to prevent.” (Grace Kyser)

“The current irrational ‘recommendation’ gives insurance companies an excuse to deny ALL tests of vitamin D — even if the proper code is supplied. The result is — people suffer. This recommendation does harm!” (Dr JJ Gold)

“Essentially, they are saying let’s not screen ‘healthy’ individuals and ignore it altogether. Better to wait till they’re old, pregnant, or already sick and diagnosed with a disease. This is the problem with the healthcare in this country.” (Brittney Lesher)

“Until allopathic medicine stops waiting for severe symptoms to develop before even screening for potential health problems, the most expensive healthcare (aka, sick care) system in the world will continue to be content to focus on medical emergencies and ignore prevention. ...” (Dean Raffelock)

“Don’t test? Are you kidding me? Especially when people are supplementing? That is akin to taking a blood pressure medication without measuring blood pressures! ... Don’t test? Don’t supplement? ... I have only one explanation for such nonsense: Pharma lives off sick people, not healthy ones.” (Georg Schlomka)

On a somewhat conciliatory and pointed note, Dr Francesca Luna-Rudin commented, “I would like to remind all of my fellow physicians that recommendations should be regarded as just that, a ‘recommendation.’ As doctors, we can use guidelines and recommendations in our practice, but if a new one is presented that does not make sense or would lead to harm based on our education and training, then we are not bound to follow it!”

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

A recent report by this news organization of a vitamin D clinical practice guideline released by the Endocrine Society in June triggered an outpouring of objections in the comments section from doctors and other readers.

A society press release listed the key new recommendations on the use of vitamin D supplementation and screening to reduce disease risks in individuals without established indications for such treatment or testing:

  • For healthy adults younger than 75, no supplementation at doses above the recommended dietary intakes.
  • Populations that may benefit from higher doses include: children and adolescents 18 and younger to prevent rickets and to reduce risk for respiratory infection, individuals 75 and older to possibly lower mortality risk, “pregnant people” to potentially reduce various risks, and people with prediabetes to potentially reduce risk of progression.
  • No routine testing for 25-hydroxyvitamin D levels because outcome-specific benefits based on those levels have not been identified (including screening in people with dark complexion or obesity).
  • Based on insufficient evidence, the panel could not determine specific blood-level thresholds for 25-hydroxyvitamin D for adequacy or for target levels for disease prevention.

This news organization covered the guideline release and simultaneous presentation at the Endocrine Society annual meeting. In response to the coverage, more than 200 doctors and other readers expressed concerns about the guideline, and some said outright that they would not follow it (readers quoted below are identified by the usernames they registered with on the website).

One reader who posted as Dr. Joseph Destefano went so far as to call the guideline “dangerous” and “almost ... evil.” Ironically, some readers attacked this news organization, thinking that the coverage implied an endorsement, rather than a news report.
 

Ignores Potential Benefits

Although the guideline is said to be for people who are “otherwise healthy” (other than the exceptions noted above), many readers were concerned that the recommendations ignore the potential benefits of supplementation for other health conditions relevant to patients and other populations.

“They address issues dealing only with endocrinology and bone health for the most part,” Dr. Emilio Gonzalez wrote. “However, vitamin D insufficiency and deficiency are not rare, and they impact the treatment of autoimmune disorders, chronic pain control, immunosuppression, cancer prevention, cardiovascular health, etc. There is plenty of literature in this regard.”

“They make these claims as if quality studies contradicting their guidelines have not been out there for years,” Dr. Brian Batcheldor said. “What about the huge demographic with diseases that impact intestinal absorption, eg, Crohn’s and celiac disease, cystic fibrosis, and ulcerative colitis? What about the one in nine that now have autoimmune diseases still awaiting diagnosis? What about night workers or anyone with more restricted access to sun exposure? How about those whose cultural or religious dress code limit skin exposure?”

The latter group was also mentioned in a post from Dr. Eve Finkelstein who said, “They don’t take into account women who are totally covered for religious reasons. They have no skin other than part of their face exposed. It does not make sense not to supplement them. Ignoring women’s health needs seems to be the norm.”

“I don’t think they considered the oral health effects of vitamin D deficiency,” pointed out commenter Corie Lewis. “Excess dental calculus (tartar) from excess calcium/phosphate in saliva significantly increases an individual’s periodontal disease risks (gum disease), and low saliva calcium/phosphate increases dental caries (cavities) risks, which generally indicates an imbalance of the oral microbiome. Vitamin D can help create balance and reduce those oral health risks.”

Noted Kimberley Morris-Windisch, “Having worked in rheumatology and pain for most of my career, I have seen too many people benefit from correcting deficiency of vitamin D. To ignore this is to miss opportunities to improve patient health.” Furthermore, “I find it unlikely that it would only improve mortality after age 75. That makes no sense.”

“Also,” she added, “what is the number [needed] to harm? In my 25 years, I have seen vitamin D toxicity once and an excessively high level without symptoms one other time.”

“WHY? Just WHY?” lamented Anne Kinchen. “Low levels in pregnant women have long-term effects on the developing fetus — higher and earlier rates of osteopenia in female children, weaker immune systems overall. There are just SO many reasons to test. These guidelines for no testing are absurd!”
 

 

 

No Screening, No Need for Decision-Making?

Several readers questioned the society’s rationale for not screening, as expressed by session moderator Clifford J. Rosen, MD, director of Clinical and Translational Research and senior scientist at Maine Medical Center Research Institute, Scarborough, Maine.

“When clinicians measure vitamin D, then they’re forced to make a decision what to do about it,” Dr. Rosen said. “That’s where questions about the levels come in. And that’s a big problem. So what the panel’s saying is, don’t screen. ... This really gets to the heart of the issue, because we have no data that there’s anything about screening that allows us to improve quality of life. ... Screening is probably not worthwhile in any age group.”

Among the reader comments in this regard:

“So misguided. Don’t look because we don’t know what do to with data. That’s the message this article exposes. The recommendation is do nothing. But, doing nothing IS an action — not a default.” (Lisa Tracy)

“So now, you will not screen for vitamin D because you do not know what to do next? See a naturopathic doctor — we know what to do next!” (Dr. Joyce Roberson)

“Gee, how do we treat it? ... What to do? Sounds incompetent at minimum. I suspect it’s vital, easy, and inexpensive ... so hide it.” (Holly Kohley)

“Just because we do not know is not a rationale for not testing. The opposite should be done.” (Dr. JJ Gold)
 

Caters to Industry?

Many commentators intimated that pharma and/or insurance company considerations played a role in the recommendations. Their comments included the following:

“I have been under the impression people do routine checkups to verify there are no hidden problems. If only some testing is done, the probability of not finding a problem is huge. ... Preventive healthcare should be looking for something to prevent instead of waiting until they can cure it. Of course, it might come back to ‘follow the money.’ It is much more profitable to diagnose and treat than it is to prevent.” (Grace Kyser)

“The current irrational ‘recommendation’ gives insurance companies an excuse to deny ALL tests of vitamin D — even if the proper code is supplied. The result is — people suffer. This recommendation does harm!” (Dr JJ Gold)

“Essentially, they are saying let’s not screen ‘healthy’ individuals and ignore it altogether. Better to wait till they’re old, pregnant, or already sick and diagnosed with a disease. This is the problem with the healthcare in this country.” (Brittney Lesher)

“Until allopathic medicine stops waiting for severe symptoms to develop before even screening for potential health problems, the most expensive healthcare (aka, sick care) system in the world will continue to be content to focus on medical emergencies and ignore prevention. ...” (Dean Raffelock)

“Don’t test? Are you kidding me? Especially when people are supplementing? That is akin to taking a blood pressure medication without measuring blood pressures! ... Don’t test? Don’t supplement? ... I have only one explanation for such nonsense: Pharma lives off sick people, not healthy ones.” (Georg Schlomka)

On a somewhat conciliatory and pointed note, Dr Francesca Luna-Rudin commented, “I would like to remind all of my fellow physicians that recommendations should be regarded as just that, a ‘recommendation.’ As doctors, we can use guidelines and recommendations in our practice, but if a new one is presented that does not make sense or would lead to harm based on our education and training, then we are not bound to follow it!”

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

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