MDedge Pediatrics

Amplified by the childhood obesity epidemic, primary hypertension is now the leading type of pediatric hypertension, especially in adolescence, yet the condition is “underrecognized,” the American Heart Association said in a new scientific statement.

“Children can have secondary hypertension that is caused by an underlying condition such as chronic kidney disease, endocrine disorders, cardiac anomalies, and some syndromes. However, primary hypertension is now recognized as the most common type of hypertension in childhood,” Bonita Falkner, MD, chair of the writing group and emeritus professor of medicine and pediatrics, Thomas Jefferson University, Philadelphia, said in an interview.

And hypertensive children are “highly likely” to become hypertensive adults and to have measurable target organ injury, particularly left ventricular hypertrophy and vascular stiffening, the writing group noted. 

The AHA statement on primary pediatric hypertension was published online in Hypertension.

Primary or essential hypertension occurs in up to 5% of children and adolescents in the United States and other countries.

The American Academy of Pediatrics (AAP), European Society of Hypertension and Hypertension Canada all define hypertension as repeated BP readings at or above the 95th percentile for children, but the thresholds differ by age.

The AAP adopts 130/80 mm Hg starting at age 13 years; the European Society of Hypertension adopts 140/90 mm Hg starting at age 16 years; and Hypertension Canada adopts 120/80 mm Hg for those aged 6-11 years and 130/85 mm Hg for those aged 12-17 years.

Adolescents entering adulthood with a BP < 120/80 mm Hg is an optimal goal, the writing group advised.

They recommend that health care professionals be trained on evidence-based methods to obtain accurate and reliable BP values with either auscultatory or oscillometric methods.

When the initial BP measurement is abnormal, repeat measurement by auscultation is recommended, within the same visit if possible, and then within weeks if the screening BP is hypertensive, or months if the screening BP is elevated.

Because BP levels are variable, even within a single visit, “best practice” is to obtain up to three BP measurements and to record the average of the latter two measurements unless the first measurement is normal, the writing group said. Further confirmation of diagnosis of hypertension can be obtained with 24-hour ambulatory BP monitoring (ABPM).

“Primary hypertension in youth is difficult to recognize in asymptomatic, otherwise healthy youth. There is now evidence that children and adolescents with primary hypertension may also have cardiac and vascular injury due to the hypertension,” Dr. Falkner told this news organization.

“If not identified and treated, the condition can progress to hypertension in young adulthood with heightened risk of premature cardiovascular events,” Dr. Falkner said.

The writing group said “primordial prevention” is an important public health goal because a population with lower BP will have fewer comorbidities related to hypertension and CVD.

Modifiable risk factors for primary hypertension in childhood include obesity, physical inactivity and poor diet/nutrition, disturbed sleep patterns, and environmental stress.

A healthy lifestyle in childhood – including eating healthy food, encouraging physical activity that leads to improved physical fitness and healthy sleep, and avoiding the development of obesity – may help mitigate the risk of hypertension in childhood, the writing group noted.  

Looking ahead, they said efforts to improve recognition and diagnosis of high BP in children, as well as clinical trials to evaluate medical treatment and recommend public health initiatives, are all vital to combat rising rates of primary hypertension in children.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Cardiovascular and Stroke Nursing.
 

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

Amplified by the childhood obesity epidemic, primary hypertension is now the leading type of pediatric hypertension, especially in adolescence, yet the condition is “underrecognized,” the American Heart Association said in a new scientific statement.

“Children can have secondary hypertension that is caused by an underlying condition such as chronic kidney disease, endocrine disorders, cardiac anomalies, and some syndromes. However, primary hypertension is now recognized as the most common type of hypertension in childhood,” Bonita Falkner, MD, chair of the writing group and emeritus professor of medicine and pediatrics, Thomas Jefferson University, Philadelphia, said in an interview.

And hypertensive children are “highly likely” to become hypertensive adults and to have measurable target organ injury, particularly left ventricular hypertrophy and vascular stiffening, the writing group noted. 

The AHA statement on primary pediatric hypertension was published online in Hypertension.

Primary or essential hypertension occurs in up to 5% of children and adolescents in the United States and other countries.

The American Academy of Pediatrics (AAP), European Society of Hypertension and Hypertension Canada all define hypertension as repeated BP readings at or above the 95th percentile for children, but the thresholds differ by age.

The AAP adopts 130/80 mm Hg starting at age 13 years; the European Society of Hypertension adopts 140/90 mm Hg starting at age 16 years; and Hypertension Canada adopts 120/80 mm Hg for those aged 6-11 years and 130/85 mm Hg for those aged 12-17 years.

Adolescents entering adulthood with a BP < 120/80 mm Hg is an optimal goal, the writing group advised.

They recommend that health care professionals be trained on evidence-based methods to obtain accurate and reliable BP values with either auscultatory or oscillometric methods.

When the initial BP measurement is abnormal, repeat measurement by auscultation is recommended, within the same visit if possible, and then within weeks if the screening BP is hypertensive, or months if the screening BP is elevated.

Because BP levels are variable, even within a single visit, “best practice” is to obtain up to three BP measurements and to record the average of the latter two measurements unless the first measurement is normal, the writing group said. Further confirmation of diagnosis of hypertension can be obtained with 24-hour ambulatory BP monitoring (ABPM).

“Primary hypertension in youth is difficult to recognize in asymptomatic, otherwise healthy youth. There is now evidence that children and adolescents with primary hypertension may also have cardiac and vascular injury due to the hypertension,” Dr. Falkner told this news organization.

“If not identified and treated, the condition can progress to hypertension in young adulthood with heightened risk of premature cardiovascular events,” Dr. Falkner said.

The writing group said “primordial prevention” is an important public health goal because a population with lower BP will have fewer comorbidities related to hypertension and CVD.

Modifiable risk factors for primary hypertension in childhood include obesity, physical inactivity and poor diet/nutrition, disturbed sleep patterns, and environmental stress.

A healthy lifestyle in childhood – including eating healthy food, encouraging physical activity that leads to improved physical fitness and healthy sleep, and avoiding the development of obesity – may help mitigate the risk of hypertension in childhood, the writing group noted.  

Looking ahead, they said efforts to improve recognition and diagnosis of high BP in children, as well as clinical trials to evaluate medical treatment and recommend public health initiatives, are all vital to combat rising rates of primary hypertension in children.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Cardiovascular and Stroke Nursing.
 

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

Amplified by the childhood obesity epidemic, primary hypertension is now the leading type of pediatric hypertension, especially in adolescence, yet the condition is “underrecognized,” the American Heart Association said in a new scientific statement.

“Children can have secondary hypertension that is caused by an underlying condition such as chronic kidney disease, endocrine disorders, cardiac anomalies, and some syndromes. However, primary hypertension is now recognized as the most common type of hypertension in childhood,” Bonita Falkner, MD, chair of the writing group and emeritus professor of medicine and pediatrics, Thomas Jefferson University, Philadelphia, said in an interview.

And hypertensive children are “highly likely” to become hypertensive adults and to have measurable target organ injury, particularly left ventricular hypertrophy and vascular stiffening, the writing group noted. 

The AHA statement on primary pediatric hypertension was published online in Hypertension.

Primary or essential hypertension occurs in up to 5% of children and adolescents in the United States and other countries.

The American Academy of Pediatrics (AAP), European Society of Hypertension and Hypertension Canada all define hypertension as repeated BP readings at or above the 95th percentile for children, but the thresholds differ by age.

The AAP adopts 130/80 mm Hg starting at age 13 years; the European Society of Hypertension adopts 140/90 mm Hg starting at age 16 years; and Hypertension Canada adopts 120/80 mm Hg for those aged 6-11 years and 130/85 mm Hg for those aged 12-17 years.

Adolescents entering adulthood with a BP < 120/80 mm Hg is an optimal goal, the writing group advised.

They recommend that health care professionals be trained on evidence-based methods to obtain accurate and reliable BP values with either auscultatory or oscillometric methods.

When the initial BP measurement is abnormal, repeat measurement by auscultation is recommended, within the same visit if possible, and then within weeks if the screening BP is hypertensive, or months if the screening BP is elevated.

Because BP levels are variable, even within a single visit, “best practice” is to obtain up to three BP measurements and to record the average of the latter two measurements unless the first measurement is normal, the writing group said. Further confirmation of diagnosis of hypertension can be obtained with 24-hour ambulatory BP monitoring (ABPM).

“Primary hypertension in youth is difficult to recognize in asymptomatic, otherwise healthy youth. There is now evidence that children and adolescents with primary hypertension may also have cardiac and vascular injury due to the hypertension,” Dr. Falkner told this news organization.

“If not identified and treated, the condition can progress to hypertension in young adulthood with heightened risk of premature cardiovascular events,” Dr. Falkner said.

The writing group said “primordial prevention” is an important public health goal because a population with lower BP will have fewer comorbidities related to hypertension and CVD.

Modifiable risk factors for primary hypertension in childhood include obesity, physical inactivity and poor diet/nutrition, disturbed sleep patterns, and environmental stress.

A healthy lifestyle in childhood – including eating healthy food, encouraging physical activity that leads to improved physical fitness and healthy sleep, and avoiding the development of obesity – may help mitigate the risk of hypertension in childhood, the writing group noted.  

Looking ahead, they said efforts to improve recognition and diagnosis of high BP in children, as well as clinical trials to evaluate medical treatment and recommend public health initiatives, are all vital to combat rising rates of primary hypertension in children.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Cardiovascular and Stroke Nursing.
 

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

NEW ORLEANS – The sociodemographic characteristics of Black and Hispanic children with systemic lupus erythematosus (SLE) appear to play a strong role in influencing the severity of disease in these patients, according to two studies presented at the Pediatric Rheumatology Symposium.

One study showed an association between multiple determinants of health and disease severity among children seen in a large Texas city, and a separate descriptive cross-sectional cohort study of predominantly Black children at two centers in Mississippi and Alabama reinforced the finding of greater severity of disease and social hardships among this racial group.

The findings from both studies supplement existing evidence that the prevalence of childhood-onset SLE is greater among Black and Hispanic children.

“Several demographic and social determinants of health parameters influenced disease severity at levels that reached statistical significance, including insurance status, race/ethnicity, referral source, PCP [primary care provider] availability, primary language, and transportation needs,” Emily Beil, MD, a pediatric rheumatologist at Texas Children’s Hospital in Houston, told attendees at the conference, which was sponsored by the American College of Rheumatology. Her team’s goal, she said, was to “better understand our patient population and social disparities that contribute to disease severity.”

Dr. Beil and her colleagues conducted a retrospective review of 136 children who had been diagnosed with childhood-onset SLE between January 2018 and May 2022 at Texas Children’s Hospital. Only children who were younger than 18 years at the time of diagnosis at Texas Children’s were included. The analysis considered demographics, clinical characteristics, insurance status, social work consultation, access to a primary care provider, transportation needs, primary language, and other parameters related to social determinants of health.

The average age of the patients was 13 years, and most were girls (82%). Just over half were Hispanic (53%), and just over a quarter were Black (26%). Half had Medicaid or participated in the Children’s Health Insurance Program (CHIP), and 1 in 10 were uninsured (10%). Half the diagnoses were made during an inpatient admission; 36% were made on the floor, and 14% were made in the intensive care unit (ICU).

The average Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 12.5, and 48.5% of patients had severe disease, indicated by a score of at least 12. Only two in three children were documented as having a primary care physician (66%), and 32% preferred a language other than English. Most of the children (80%) had a social work consult.

Black and biracial children had higher SLEDAI scores at presentation. Non-Hispanic White children were less likely to have a social work consult, compared with other racial/ethnic groups (P = .01 for both). Central nervous system involvement was most prevalent among Black patients (P = .004). Cyclophosphamide was used most often for Black and biracial patients.

Uninsured patients were most likely to be diagnosed on an inpatient floor. The highest proportion of ICU admissions was among patients insured by Medicaid (P = .034). Average SLEDAI scores were highest among uninsured patients, followed by Medicaid patients. More than half of the patients who did not have insurance lacked access to a regular primary care provider, compared with 12% of Medicaid patients and 7% of privately insured patients (P = .001). All the uninsured patients had transportation needs, which was a significantly higher rate than among those with Medicaid (13%) or private insurance (15%) (P = .001). The highest percentage of social work consults was among patients who were insured by Medicaid or were without insurance (P = .001).
 

Salient demographics and clinical features

In the second presentation, Anita Dhanrajani, MD, assistant professor of pediatrics at the University of Mississippi Medical Center in Jackson, began by noting that Alabama and Mississippi are ranked in the top 10 states for the highest poverty rate: Mississippi is No. 1, and Alabama is No. 7. Further, 40% of children in Mississippi and 29% of children in Alabama are of African American ancestry, she said.

“So, we know that this population that we’re dealing with has several high-risk factors that can lead them to have poor outcomes, and yet, we haven’t really ever characterized their clinical features or their social demographic features,” Dr. Dhanrajani told attendees. “My hope is that with this very miniscule first step, we’re able to move towards solutions to decrease health care disparities in this population.”

She presented findings regarding the first of three aims in the study, which was to describe the baseline clinical, demographic, and socioeconomic profiles of childhood lupus patients at the two centers. The two other aims were to examine genetic factors potentially linked to poor outcomes in the cohort and to assess the mental health status of the population.

The study relied on a retrospective chart review for the 17 patients at the University of Mississippi Medical Center and on Childhood Arthritis and Rheumatology Research Alliance registry data for the 19 patients at the University of Alabama at Birmingham. Most of the patients (86%) were female, Black (78%), and insured by Medicaid (64%). The average age at diagnosis was 13 years. Most (83%) also lived in a ZIP code that met the criteria for a medium-high or high Social Vulnerability Index. The children had to travel an average 75 miles to see a rheumatologist, compared with the national average of 43 miles.

At diagnosis, their average Systemic Lupus International Collaborating Clinics (SLICC) score was 8.8, their average American College of Rheumatology score was 5.2, and their average SLEDAI score was 12.1 – the latter was substantially higher than the average 3.1 score in a multiethnic Canadian cohort (the 1000 Canadian Faces of Lupus Study) with 10% Black children (P < .00001). The SLEDAI score dropped to 6.8 at 6 months and to 4 at 1 year. Nearly half (47%) had a SLICC Damage Index (SDI) greater than 0, and one-third had an SDI of 2 or greater, compared with 16% and 7%, respectively, reported in other recent studies (P < .0001 for both).

“These disparities are very difficult to investigate in terms of causal relationships and [are] likely to be very modifiable,” Coziana Ciurtin, MD, PhD, associate professor of rheumatology at University College London, told this news organization. “I think the socioeconomic status, the level of education, poverty, [type of] medical insurance, and probably genetic variants are all underpinning the presentation, damage, or disease activity being very high, and also organ involvement,” such as the greater CNS involvement seen in non-White patients.

Being mindful of these risk profiles can help doctors in asking about patients’ support at home and their families’ education, beliefs, and cultural practices, Dr. Ciurtin added. “Helping them to engage and be involved in decision-making is probably the most important” aspect of learning this information about families, she said.

Collecting this information should not be the sole responsibility of the physician, added Eve Smith, PhD, MBCHB, an academic clinical lecturer at the University of Liverpool, England, who attended the presentations. Dr. Smith noted a discussion in a work group during the previous day of the conference concerning questionnaires for screening patients regarding the need for social services and for identifying areas in which patients and their families were having difficulties.

“Obviously, if you’re going to do that, you have to have access to someone who can actually help to deal with that. Some hospitals have patient navigators that can help, for example, with a food security issue to highlight resources within the community, so it’s not all on the doctor,” Dr. Smith said. “To really make a difference in this area, it can’t just be down to the doctor. There needs to be social care, there needs to be community-based interventions and things to do about it. Doctors can help identify these patients, or maybe somebody in the [medical] team can help with that, but there needs to be an intervention. Otherwise, you’re left with this problem without a solution that you can’t do anything about.”

The researchers did not note any external funding for either study. Dr. Beil, Dr. Dhanrajani, Dr. Smith, and Dr. Ciurtin reported no relevant financial relationships.

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

NEW ORLEANS – The sociodemographic characteristics of Black and Hispanic children with systemic lupus erythematosus (SLE) appear to play a strong role in influencing the severity of disease in these patients, according to two studies presented at the Pediatric Rheumatology Symposium.

One study showed an association between multiple determinants of health and disease severity among children seen in a large Texas city, and a separate descriptive cross-sectional cohort study of predominantly Black children at two centers in Mississippi and Alabama reinforced the finding of greater severity of disease and social hardships among this racial group.

The findings from both studies supplement existing evidence that the prevalence of childhood-onset SLE is greater among Black and Hispanic children.

“Several demographic and social determinants of health parameters influenced disease severity at levels that reached statistical significance, including insurance status, race/ethnicity, referral source, PCP [primary care provider] availability, primary language, and transportation needs,” Emily Beil, MD, a pediatric rheumatologist at Texas Children’s Hospital in Houston, told attendees at the conference, which was sponsored by the American College of Rheumatology. Her team’s goal, she said, was to “better understand our patient population and social disparities that contribute to disease severity.”

Dr. Beil and her colleagues conducted a retrospective review of 136 children who had been diagnosed with childhood-onset SLE between January 2018 and May 2022 at Texas Children’s Hospital. Only children who were younger than 18 years at the time of diagnosis at Texas Children’s were included. The analysis considered demographics, clinical characteristics, insurance status, social work consultation, access to a primary care provider, transportation needs, primary language, and other parameters related to social determinants of health.

The average age of the patients was 13 years, and most were girls (82%). Just over half were Hispanic (53%), and just over a quarter were Black (26%). Half had Medicaid or participated in the Children’s Health Insurance Program (CHIP), and 1 in 10 were uninsured (10%). Half the diagnoses were made during an inpatient admission; 36% were made on the floor, and 14% were made in the intensive care unit (ICU).

The average Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 12.5, and 48.5% of patients had severe disease, indicated by a score of at least 12. Only two in three children were documented as having a primary care physician (66%), and 32% preferred a language other than English. Most of the children (80%) had a social work consult.

Black and biracial children had higher SLEDAI scores at presentation. Non-Hispanic White children were less likely to have a social work consult, compared with other racial/ethnic groups (P = .01 for both). Central nervous system involvement was most prevalent among Black patients (P = .004). Cyclophosphamide was used most often for Black and biracial patients.

Uninsured patients were most likely to be diagnosed on an inpatient floor. The highest proportion of ICU admissions was among patients insured by Medicaid (P = .034). Average SLEDAI scores were highest among uninsured patients, followed by Medicaid patients. More than half of the patients who did not have insurance lacked access to a regular primary care provider, compared with 12% of Medicaid patients and 7% of privately insured patients (P = .001). All the uninsured patients had transportation needs, which was a significantly higher rate than among those with Medicaid (13%) or private insurance (15%) (P = .001). The highest percentage of social work consults was among patients who were insured by Medicaid or were without insurance (P = .001).
 

Salient demographics and clinical features

In the second presentation, Anita Dhanrajani, MD, assistant professor of pediatrics at the University of Mississippi Medical Center in Jackson, began by noting that Alabama and Mississippi are ranked in the top 10 states for the highest poverty rate: Mississippi is No. 1, and Alabama is No. 7. Further, 40% of children in Mississippi and 29% of children in Alabama are of African American ancestry, she said.

“So, we know that this population that we’re dealing with has several high-risk factors that can lead them to have poor outcomes, and yet, we haven’t really ever characterized their clinical features or their social demographic features,” Dr. Dhanrajani told attendees. “My hope is that with this very miniscule first step, we’re able to move towards solutions to decrease health care disparities in this population.”

She presented findings regarding the first of three aims in the study, which was to describe the baseline clinical, demographic, and socioeconomic profiles of childhood lupus patients at the two centers. The two other aims were to examine genetic factors potentially linked to poor outcomes in the cohort and to assess the mental health status of the population.

The study relied on a retrospective chart review for the 17 patients at the University of Mississippi Medical Center and on Childhood Arthritis and Rheumatology Research Alliance registry data for the 19 patients at the University of Alabama at Birmingham. Most of the patients (86%) were female, Black (78%), and insured by Medicaid (64%). The average age at diagnosis was 13 years. Most (83%) also lived in a ZIP code that met the criteria for a medium-high or high Social Vulnerability Index. The children had to travel an average 75 miles to see a rheumatologist, compared with the national average of 43 miles.

At diagnosis, their average Systemic Lupus International Collaborating Clinics (SLICC) score was 8.8, their average American College of Rheumatology score was 5.2, and their average SLEDAI score was 12.1 – the latter was substantially higher than the average 3.1 score in a multiethnic Canadian cohort (the 1000 Canadian Faces of Lupus Study) with 10% Black children (P < .00001). The SLEDAI score dropped to 6.8 at 6 months and to 4 at 1 year. Nearly half (47%) had a SLICC Damage Index (SDI) greater than 0, and one-third had an SDI of 2 or greater, compared with 16% and 7%, respectively, reported in other recent studies (P < .0001 for both).

“These disparities are very difficult to investigate in terms of causal relationships and [are] likely to be very modifiable,” Coziana Ciurtin, MD, PhD, associate professor of rheumatology at University College London, told this news organization. “I think the socioeconomic status, the level of education, poverty, [type of] medical insurance, and probably genetic variants are all underpinning the presentation, damage, or disease activity being very high, and also organ involvement,” such as the greater CNS involvement seen in non-White patients.

Being mindful of these risk profiles can help doctors in asking about patients’ support at home and their families’ education, beliefs, and cultural practices, Dr. Ciurtin added. “Helping them to engage and be involved in decision-making is probably the most important” aspect of learning this information about families, she said.

Collecting this information should not be the sole responsibility of the physician, added Eve Smith, PhD, MBCHB, an academic clinical lecturer at the University of Liverpool, England, who attended the presentations. Dr. Smith noted a discussion in a work group during the previous day of the conference concerning questionnaires for screening patients regarding the need for social services and for identifying areas in which patients and their families were having difficulties.

“Obviously, if you’re going to do that, you have to have access to someone who can actually help to deal with that. Some hospitals have patient navigators that can help, for example, with a food security issue to highlight resources within the community, so it’s not all on the doctor,” Dr. Smith said. “To really make a difference in this area, it can’t just be down to the doctor. There needs to be social care, there needs to be community-based interventions and things to do about it. Doctors can help identify these patients, or maybe somebody in the [medical] team can help with that, but there needs to be an intervention. Otherwise, you’re left with this problem without a solution that you can’t do anything about.”

The researchers did not note any external funding for either study. Dr. Beil, Dr. Dhanrajani, Dr. Smith, and Dr. Ciurtin reported no relevant financial relationships.

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

NEW ORLEANS – The sociodemographic characteristics of Black and Hispanic children with systemic lupus erythematosus (SLE) appear to play a strong role in influencing the severity of disease in these patients, according to two studies presented at the Pediatric Rheumatology Symposium.

One study showed an association between multiple determinants of health and disease severity among children seen in a large Texas city, and a separate descriptive cross-sectional cohort study of predominantly Black children at two centers in Mississippi and Alabama reinforced the finding of greater severity of disease and social hardships among this racial group.

The findings from both studies supplement existing evidence that the prevalence of childhood-onset SLE is greater among Black and Hispanic children.

“Several demographic and social determinants of health parameters influenced disease severity at levels that reached statistical significance, including insurance status, race/ethnicity, referral source, PCP [primary care provider] availability, primary language, and transportation needs,” Emily Beil, MD, a pediatric rheumatologist at Texas Children’s Hospital in Houston, told attendees at the conference, which was sponsored by the American College of Rheumatology. Her team’s goal, she said, was to “better understand our patient population and social disparities that contribute to disease severity.”

Dr. Beil and her colleagues conducted a retrospective review of 136 children who had been diagnosed with childhood-onset SLE between January 2018 and May 2022 at Texas Children’s Hospital. Only children who were younger than 18 years at the time of diagnosis at Texas Children’s were included. The analysis considered demographics, clinical characteristics, insurance status, social work consultation, access to a primary care provider, transportation needs, primary language, and other parameters related to social determinants of health.

The average age of the patients was 13 years, and most were girls (82%). Just over half were Hispanic (53%), and just over a quarter were Black (26%). Half had Medicaid or participated in the Children’s Health Insurance Program (CHIP), and 1 in 10 were uninsured (10%). Half the diagnoses were made during an inpatient admission; 36% were made on the floor, and 14% were made in the intensive care unit (ICU).

The average Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 12.5, and 48.5% of patients had severe disease, indicated by a score of at least 12. Only two in three children were documented as having a primary care physician (66%), and 32% preferred a language other than English. Most of the children (80%) had a social work consult.

Black and biracial children had higher SLEDAI scores at presentation. Non-Hispanic White children were less likely to have a social work consult, compared with other racial/ethnic groups (P = .01 for both). Central nervous system involvement was most prevalent among Black patients (P = .004). Cyclophosphamide was used most often for Black and biracial patients.

Uninsured patients were most likely to be diagnosed on an inpatient floor. The highest proportion of ICU admissions was among patients insured by Medicaid (P = .034). Average SLEDAI scores were highest among uninsured patients, followed by Medicaid patients. More than half of the patients who did not have insurance lacked access to a regular primary care provider, compared with 12% of Medicaid patients and 7% of privately insured patients (P = .001). All the uninsured patients had transportation needs, which was a significantly higher rate than among those with Medicaid (13%) or private insurance (15%) (P = .001). The highest percentage of social work consults was among patients who were insured by Medicaid or were without insurance (P = .001).
 

Salient demographics and clinical features

In the second presentation, Anita Dhanrajani, MD, assistant professor of pediatrics at the University of Mississippi Medical Center in Jackson, began by noting that Alabama and Mississippi are ranked in the top 10 states for the highest poverty rate: Mississippi is No. 1, and Alabama is No. 7. Further, 40% of children in Mississippi and 29% of children in Alabama are of African American ancestry, she said.

“So, we know that this population that we’re dealing with has several high-risk factors that can lead them to have poor outcomes, and yet, we haven’t really ever characterized their clinical features or their social demographic features,” Dr. Dhanrajani told attendees. “My hope is that with this very miniscule first step, we’re able to move towards solutions to decrease health care disparities in this population.”

She presented findings regarding the first of three aims in the study, which was to describe the baseline clinical, demographic, and socioeconomic profiles of childhood lupus patients at the two centers. The two other aims were to examine genetic factors potentially linked to poor outcomes in the cohort and to assess the mental health status of the population.

The study relied on a retrospective chart review for the 17 patients at the University of Mississippi Medical Center and on Childhood Arthritis and Rheumatology Research Alliance registry data for the 19 patients at the University of Alabama at Birmingham. Most of the patients (86%) were female, Black (78%), and insured by Medicaid (64%). The average age at diagnosis was 13 years. Most (83%) also lived in a ZIP code that met the criteria for a medium-high or high Social Vulnerability Index. The children had to travel an average 75 miles to see a rheumatologist, compared with the national average of 43 miles.

At diagnosis, their average Systemic Lupus International Collaborating Clinics (SLICC) score was 8.8, their average American College of Rheumatology score was 5.2, and their average SLEDAI score was 12.1 – the latter was substantially higher than the average 3.1 score in a multiethnic Canadian cohort (the 1000 Canadian Faces of Lupus Study) with 10% Black children (P < .00001). The SLEDAI score dropped to 6.8 at 6 months and to 4 at 1 year. Nearly half (47%) had a SLICC Damage Index (SDI) greater than 0, and one-third had an SDI of 2 or greater, compared with 16% and 7%, respectively, reported in other recent studies (P < .0001 for both).

“These disparities are very difficult to investigate in terms of causal relationships and [are] likely to be very modifiable,” Coziana Ciurtin, MD, PhD, associate professor of rheumatology at University College London, told this news organization. “I think the socioeconomic status, the level of education, poverty, [type of] medical insurance, and probably genetic variants are all underpinning the presentation, damage, or disease activity being very high, and also organ involvement,” such as the greater CNS involvement seen in non-White patients.

Being mindful of these risk profiles can help doctors in asking about patients’ support at home and their families’ education, beliefs, and cultural practices, Dr. Ciurtin added. “Helping them to engage and be involved in decision-making is probably the most important” aspect of learning this information about families, she said.

Collecting this information should not be the sole responsibility of the physician, added Eve Smith, PhD, MBCHB, an academic clinical lecturer at the University of Liverpool, England, who attended the presentations. Dr. Smith noted a discussion in a work group during the previous day of the conference concerning questionnaires for screening patients regarding the need for social services and for identifying areas in which patients and their families were having difficulties.

“Obviously, if you’re going to do that, you have to have access to someone who can actually help to deal with that. Some hospitals have patient navigators that can help, for example, with a food security issue to highlight resources within the community, so it’s not all on the doctor,” Dr. Smith said. “To really make a difference in this area, it can’t just be down to the doctor. There needs to be social care, there needs to be community-based interventions and things to do about it. Doctors can help identify these patients, or maybe somebody in the [medical] team can help with that, but there needs to be an intervention. Otherwise, you’re left with this problem without a solution that you can’t do anything about.”

The researchers did not note any external funding for either study. Dr. Beil, Dr. Dhanrajani, Dr. Smith, and Dr. Ciurtin reported no relevant financial relationships.

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

NEW ORLEANS – More than one-third of pediatric residency programs do not have a pediatric rheumatologist on faculty, a situation that has changed little since 2004, according to a poster presented at the Pediatric Rheumatology Symposium 2023 conference.

“This shortage has significant downstream effects,” according to author Miriah Gillispie-Taylor, MD, an assistant professor of pediatric rheumatology at Baylor College of Medicine and Texas Children’s Hospital in Houston. Without adequate education, it’s unreasonable to expect that a pediatrician will recognize the great diversity of presentations among rheumatic diseases, for example. “Without recognition, patients are not referred in a timely manner, and earlier identification and treatment of rheumatic diseases leads to improved outcomes,” Dr. Gillispie-Taylor said.

Currently, eight U.S. states do not have a board-certified pediatric rheumatologist, including Alaska. Dr. Gillispie-Taylor cited a 2006 study that found that one-third of medical schools (33%) and 40% of U.S. pediatric residency programs did not have an on-site pediatric rheumatologist in 2004.

As the long-standing workforce shortage in pediatric rheumatology continues, Dr. Gillispie-Taylor and her colleagues investigated whether increasing awareness of this problem has influenced the number of United States and Puerto Rico residency training programs with pediatric rheumatology faculty from 2004 to present.

The researchers identified 212 pediatric residency programs accredited by the Accreditation Council for Graduate Medical Education for 2022-2023 and reviewed their program website to see which ones had affiliated pediatric rheumatology faculty. After determining the faculty from the website for 85% of the programs, the researchers emailed the other programs to find out whether a pediatric rheumatologist was on faculty, filling out another 6% of the programs. Most of the remaining uncategorized programs (7%) were categorized at a meeting of the Childhood Arthritis and Rheumatology Research Alliance medical education workgroup. Only 2% of programs could not be ultimately categorized.

The region with the greatest proportion of pediatric residency programs that had a pediatric rheumatologist was the Southeast, where 95% (36 of 38 programs) of programs had one on faculty. The Southwest, comprising Texas, Oklahoma, New Mexico, and Arizona, had the lowest proportion: 43% (9 of 21 programs). For the other regions, 69% of the West/Pacific Northwest (18 of 26), 62% of the Midwest (28 of 45), and 61% of the Northeast (39 of 64) programs had a pediatric rheumatologist on faculty. Three of Puerto Rico’s four programs had one as well.

Overall, 63% of programs had a pediatric rheumatologist on faculty, and 36% did not; the state of three programs was unknown.

The large proportion of programs without a pediatric rheumatologist “limits exposure to rheumatologic conditions and learning opportunities during residency and contribute to declining fellow match rates,” the authors concluded. They noted that only 62.8% of pediatric rheumatology fellowship positions were filled in 2022, down slightly from the 69.2% filled in 2021, according to report data from the National Matching Resident Program.

The researchers acknowledged that their results could be skewed if website information was outdated for any programs, and it’s difficult to determine which programs might lack resources on the basis of only publicly available information. Though programs without pediatric rheumatologists might benefit from visiting professorships, it can be difficult to identify which ones, they added.

The authors recommend two next steps: one, establishing areas of essential knowledge in pediatric rheumatology to enable the creation of learning objectives so programs can focus their educational efforts; and two, continuing efforts to understand residents’ motivation to pursue fellowships in pediatric rheumatology for the purpose of improving recruitment.

Two medical students at Dr. Gillispie-Taylor’s institution spoke with this news organization about their thoughts on the findings and how they were approaching their own career goals in medicine in light of these findings.

Kyla Fergason, a second-year medical student at Baylor College of Medicine, said that she thinks she wants to pursue pediatrics or meds-peds. Though she’s not sure whether she specifically wants to pursue pediatric rheumatology, she is very interested in the area and said that she has learned much from the Pediatric Rheumatology Symposium conference. She found the dearth of pediatric rheumatology faculty at residency programs worrisome, particularly in states like Alaska and Hawaii because they aren’t contiguous with the rest of the United States. Only three pediatric rheumatologists are practicing in Hawaii.

“It’s really concerning that sometimes there is not any rheumatologist there to see the patient,” Ms. Fergason told this news organization. “These are diseases that affect people chronically throughout their entire lives, so it’s definitely concerning to think that, at a time when they could be helped and there could be interventions made, none are made because there’s just no one available.”

Kristiana Nasto, a third-year medical student at Baylor College of Medicine, is similarly interested in pediatrics but leaning more toward meds-peds and has an interest in rheumatology as well. She was surprised at how many programs had no pediatric rheumatologist on faculty because Baylor has a robust program.

“I was not aware of the fact that other states or other parts of Texas do not have the luxury of the great rheumatologists that we have at Baylor College of Medicine,” Ms. Nasto said. “That can definitely impact care for many patients because some of these rheumatologic diseases are so unique and challenging to treat that they require specialized care, so it makes me a bit sad that this is the case.”

Dr. Gillispie-Taylor has received an educational grant from Pfizer. Ms. Fergason and Ms. Nasto had no disclosures. No external funding was noted for the study.

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

NEW ORLEANS – More than one-third of pediatric residency programs do not have a pediatric rheumatologist on faculty, a situation that has changed little since 2004, according to a poster presented at the Pediatric Rheumatology Symposium 2023 conference.

“This shortage has significant downstream effects,” according to author Miriah Gillispie-Taylor, MD, an assistant professor of pediatric rheumatology at Baylor College of Medicine and Texas Children’s Hospital in Houston. Without adequate education, it’s unreasonable to expect that a pediatrician will recognize the great diversity of presentations among rheumatic diseases, for example. “Without recognition, patients are not referred in a timely manner, and earlier identification and treatment of rheumatic diseases leads to improved outcomes,” Dr. Gillispie-Taylor said.

Currently, eight U.S. states do not have a board-certified pediatric rheumatologist, including Alaska. Dr. Gillispie-Taylor cited a 2006 study that found that one-third of medical schools (33%) and 40% of U.S. pediatric residency programs did not have an on-site pediatric rheumatologist in 2004.

As the long-standing workforce shortage in pediatric rheumatology continues, Dr. Gillispie-Taylor and her colleagues investigated whether increasing awareness of this problem has influenced the number of United States and Puerto Rico residency training programs with pediatric rheumatology faculty from 2004 to present.

The researchers identified 212 pediatric residency programs accredited by the Accreditation Council for Graduate Medical Education for 2022-2023 and reviewed their program website to see which ones had affiliated pediatric rheumatology faculty. After determining the faculty from the website for 85% of the programs, the researchers emailed the other programs to find out whether a pediatric rheumatologist was on faculty, filling out another 6% of the programs. Most of the remaining uncategorized programs (7%) were categorized at a meeting of the Childhood Arthritis and Rheumatology Research Alliance medical education workgroup. Only 2% of programs could not be ultimately categorized.

The region with the greatest proportion of pediatric residency programs that had a pediatric rheumatologist was the Southeast, where 95% (36 of 38 programs) of programs had one on faculty. The Southwest, comprising Texas, Oklahoma, New Mexico, and Arizona, had the lowest proportion: 43% (9 of 21 programs). For the other regions, 69% of the West/Pacific Northwest (18 of 26), 62% of the Midwest (28 of 45), and 61% of the Northeast (39 of 64) programs had a pediatric rheumatologist on faculty. Three of Puerto Rico’s four programs had one as well.

Overall, 63% of programs had a pediatric rheumatologist on faculty, and 36% did not; the state of three programs was unknown.

The large proportion of programs without a pediatric rheumatologist “limits exposure to rheumatologic conditions and learning opportunities during residency and contribute to declining fellow match rates,” the authors concluded. They noted that only 62.8% of pediatric rheumatology fellowship positions were filled in 2022, down slightly from the 69.2% filled in 2021, according to report data from the National Matching Resident Program.

The researchers acknowledged that their results could be skewed if website information was outdated for any programs, and it’s difficult to determine which programs might lack resources on the basis of only publicly available information. Though programs without pediatric rheumatologists might benefit from visiting professorships, it can be difficult to identify which ones, they added.

The authors recommend two next steps: one, establishing areas of essential knowledge in pediatric rheumatology to enable the creation of learning objectives so programs can focus their educational efforts; and two, continuing efforts to understand residents’ motivation to pursue fellowships in pediatric rheumatology for the purpose of improving recruitment.

Two medical students at Dr. Gillispie-Taylor’s institution spoke with this news organization about their thoughts on the findings and how they were approaching their own career goals in medicine in light of these findings.

Kyla Fergason, a second-year medical student at Baylor College of Medicine, said that she thinks she wants to pursue pediatrics or meds-peds. Though she’s not sure whether she specifically wants to pursue pediatric rheumatology, she is very interested in the area and said that she has learned much from the Pediatric Rheumatology Symposium conference. She found the dearth of pediatric rheumatology faculty at residency programs worrisome, particularly in states like Alaska and Hawaii because they aren’t contiguous with the rest of the United States. Only three pediatric rheumatologists are practicing in Hawaii.

“It’s really concerning that sometimes there is not any rheumatologist there to see the patient,” Ms. Fergason told this news organization. “These are diseases that affect people chronically throughout their entire lives, so it’s definitely concerning to think that, at a time when they could be helped and there could be interventions made, none are made because there’s just no one available.”

Kristiana Nasto, a third-year medical student at Baylor College of Medicine, is similarly interested in pediatrics but leaning more toward meds-peds and has an interest in rheumatology as well. She was surprised at how many programs had no pediatric rheumatologist on faculty because Baylor has a robust program.

“I was not aware of the fact that other states or other parts of Texas do not have the luxury of the great rheumatologists that we have at Baylor College of Medicine,” Ms. Nasto said. “That can definitely impact care for many patients because some of these rheumatologic diseases are so unique and challenging to treat that they require specialized care, so it makes me a bit sad that this is the case.”

Dr. Gillispie-Taylor has received an educational grant from Pfizer. Ms. Fergason and Ms. Nasto had no disclosures. No external funding was noted for the study.

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

NEW ORLEANS – More than one-third of pediatric residency programs do not have a pediatric rheumatologist on faculty, a situation that has changed little since 2004, according to a poster presented at the Pediatric Rheumatology Symposium 2023 conference.

“This shortage has significant downstream effects,” according to author Miriah Gillispie-Taylor, MD, an assistant professor of pediatric rheumatology at Baylor College of Medicine and Texas Children’s Hospital in Houston. Without adequate education, it’s unreasonable to expect that a pediatrician will recognize the great diversity of presentations among rheumatic diseases, for example. “Without recognition, patients are not referred in a timely manner, and earlier identification and treatment of rheumatic diseases leads to improved outcomes,” Dr. Gillispie-Taylor said.

Currently, eight U.S. states do not have a board-certified pediatric rheumatologist, including Alaska. Dr. Gillispie-Taylor cited a 2006 study that found that one-third of medical schools (33%) and 40% of U.S. pediatric residency programs did not have an on-site pediatric rheumatologist in 2004.

As the long-standing workforce shortage in pediatric rheumatology continues, Dr. Gillispie-Taylor and her colleagues investigated whether increasing awareness of this problem has influenced the number of United States and Puerto Rico residency training programs with pediatric rheumatology faculty from 2004 to present.

The researchers identified 212 pediatric residency programs accredited by the Accreditation Council for Graduate Medical Education for 2022-2023 and reviewed their program website to see which ones had affiliated pediatric rheumatology faculty. After determining the faculty from the website for 85% of the programs, the researchers emailed the other programs to find out whether a pediatric rheumatologist was on faculty, filling out another 6% of the programs. Most of the remaining uncategorized programs (7%) were categorized at a meeting of the Childhood Arthritis and Rheumatology Research Alliance medical education workgroup. Only 2% of programs could not be ultimately categorized.

The region with the greatest proportion of pediatric residency programs that had a pediatric rheumatologist was the Southeast, where 95% (36 of 38 programs) of programs had one on faculty. The Southwest, comprising Texas, Oklahoma, New Mexico, and Arizona, had the lowest proportion: 43% (9 of 21 programs). For the other regions, 69% of the West/Pacific Northwest (18 of 26), 62% of the Midwest (28 of 45), and 61% of the Northeast (39 of 64) programs had a pediatric rheumatologist on faculty. Three of Puerto Rico’s four programs had one as well.

Overall, 63% of programs had a pediatric rheumatologist on faculty, and 36% did not; the state of three programs was unknown.

The large proportion of programs without a pediatric rheumatologist “limits exposure to rheumatologic conditions and learning opportunities during residency and contribute to declining fellow match rates,” the authors concluded. They noted that only 62.8% of pediatric rheumatology fellowship positions were filled in 2022, down slightly from the 69.2% filled in 2021, according to report data from the National Matching Resident Program.

The researchers acknowledged that their results could be skewed if website information was outdated for any programs, and it’s difficult to determine which programs might lack resources on the basis of only publicly available information. Though programs without pediatric rheumatologists might benefit from visiting professorships, it can be difficult to identify which ones, they added.

The authors recommend two next steps: one, establishing areas of essential knowledge in pediatric rheumatology to enable the creation of learning objectives so programs can focus their educational efforts; and two, continuing efforts to understand residents’ motivation to pursue fellowships in pediatric rheumatology for the purpose of improving recruitment.

Two medical students at Dr. Gillispie-Taylor’s institution spoke with this news organization about their thoughts on the findings and how they were approaching their own career goals in medicine in light of these findings.

Kyla Fergason, a second-year medical student at Baylor College of Medicine, said that she thinks she wants to pursue pediatrics or meds-peds. Though she’s not sure whether she specifically wants to pursue pediatric rheumatology, she is very interested in the area and said that she has learned much from the Pediatric Rheumatology Symposium conference. She found the dearth of pediatric rheumatology faculty at residency programs worrisome, particularly in states like Alaska and Hawaii because they aren’t contiguous with the rest of the United States. Only three pediatric rheumatologists are practicing in Hawaii.

“It’s really concerning that sometimes there is not any rheumatologist there to see the patient,” Ms. Fergason told this news organization. “These are diseases that affect people chronically throughout their entire lives, so it’s definitely concerning to think that, at a time when they could be helped and there could be interventions made, none are made because there’s just no one available.”

Kristiana Nasto, a third-year medical student at Baylor College of Medicine, is similarly interested in pediatrics but leaning more toward meds-peds and has an interest in rheumatology as well. She was surprised at how many programs had no pediatric rheumatologist on faculty because Baylor has a robust program.

“I was not aware of the fact that other states or other parts of Texas do not have the luxury of the great rheumatologists that we have at Baylor College of Medicine,” Ms. Nasto said. “That can definitely impact care for many patients because some of these rheumatologic diseases are so unique and challenging to treat that they require specialized care, so it makes me a bit sad that this is the case.”

Dr. Gillispie-Taylor has received an educational grant from Pfizer. Ms. Fergason and Ms. Nasto had no disclosures. No external funding was noted for the study.

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

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

A version of this article originally appeared on WebMD.com.

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

A version of this article originally appeared on WebMD.com.

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

A version of this article originally appeared on WebMD.com.

People who had low hopes from a COVID-19 vaccine reported more negative side effects from the shots in a new study.

It fits the psychosomatic role of “nocebo effects,” the researchers say – when “psychological characteristics including anxiety, depression, and the tendency to amplify benign bodily sensations” cause participants to report more bad effects than others. 

In August 2021, researchers in Hamburg, Germany, followed 1,678 adults getting a second shot of Pfizer or Moderna mRNA-based vaccines. Participants reported symptoms in a diary, starting 2 weeks ahead of the vaccinations and going 7 days afterward.

Some participants said they weren’t expecting much benefit. Researchers said these people were more likely to “catastrophize instead of normalize benign bodily sensations.” People who’d had a bad experience with their first shot were more likely to say they felt aches, pains, and other side effects from the second.

The research was published in JAMA Network Open.

“Clinician-patient interactions and public vaccine campaigns may both benefit from these insights by optimizing and contextualizing information provided about COVID-19 vaccines,” the researchers said. “Unfavorable nocebo-related adverse effects could then be prevented, and overall vaccine acceptance could be improved.”

More than half of participants, 52.1%, expected bad effects to happen from the shot. Another 7.6% said they would be hospitalized from those bad effects, and 10.6% said the effects would last in the long term.

The Washington Times reported that “substantial numbers of patients reported adverse effects after vaccination,” but people with positive expectations reported them as minor. “Those who scored higher for anxiety, depression, and other psychosocial factors were more likely to flag these issues as severe.”
 

A version of this article originally appeared on WebMD.com.

People who had low hopes from a COVID-19 vaccine reported more negative side effects from the shots in a new study.

It fits the psychosomatic role of “nocebo effects,” the researchers say – when “psychological characteristics including anxiety, depression, and the tendency to amplify benign bodily sensations” cause participants to report more bad effects than others. 

In August 2021, researchers in Hamburg, Germany, followed 1,678 adults getting a second shot of Pfizer or Moderna mRNA-based vaccines. Participants reported symptoms in a diary, starting 2 weeks ahead of the vaccinations and going 7 days afterward.

Some participants said they weren’t expecting much benefit. Researchers said these people were more likely to “catastrophize instead of normalize benign bodily sensations.” People who’d had a bad experience with their first shot were more likely to say they felt aches, pains, and other side effects from the second.

The research was published in JAMA Network Open.

“Clinician-patient interactions and public vaccine campaigns may both benefit from these insights by optimizing and contextualizing information provided about COVID-19 vaccines,” the researchers said. “Unfavorable nocebo-related adverse effects could then be prevented, and overall vaccine acceptance could be improved.”

More than half of participants, 52.1%, expected bad effects to happen from the shot. Another 7.6% said they would be hospitalized from those bad effects, and 10.6% said the effects would last in the long term.

The Washington Times reported that “substantial numbers of patients reported adverse effects after vaccination,” but people with positive expectations reported them as minor. “Those who scored higher for anxiety, depression, and other psychosocial factors were more likely to flag these issues as severe.”
 

A version of this article originally appeared on WebMD.com.

People who had low hopes from a COVID-19 vaccine reported more negative side effects from the shots in a new study.

It fits the psychosomatic role of “nocebo effects,” the researchers say – when “psychological characteristics including anxiety, depression, and the tendency to amplify benign bodily sensations” cause participants to report more bad effects than others. 

In August 2021, researchers in Hamburg, Germany, followed 1,678 adults getting a second shot of Pfizer or Moderna mRNA-based vaccines. Participants reported symptoms in a diary, starting 2 weeks ahead of the vaccinations and going 7 days afterward.

Some participants said they weren’t expecting much benefit. Researchers said these people were more likely to “catastrophize instead of normalize benign bodily sensations.” People who’d had a bad experience with their first shot were more likely to say they felt aches, pains, and other side effects from the second.

The research was published in JAMA Network Open.

“Clinician-patient interactions and public vaccine campaigns may both benefit from these insights by optimizing and contextualizing information provided about COVID-19 vaccines,” the researchers said. “Unfavorable nocebo-related adverse effects could then be prevented, and overall vaccine acceptance could be improved.”

More than half of participants, 52.1%, expected bad effects to happen from the shot. Another 7.6% said they would be hospitalized from those bad effects, and 10.6% said the effects would last in the long term.

The Washington Times reported that “substantial numbers of patients reported adverse effects after vaccination,” but people with positive expectations reported them as minor. “Those who scored higher for anxiety, depression, and other psychosocial factors were more likely to flag these issues as severe.”
 

A version of this article originally appeared on WebMD.com.

An antiviral therapy in early development has the potential to prevent COVID-19 infections when given as a nasal spray as little as 4 hours before exposure. It also appears to work as a treatment if used within 4 hours after infection inside the nose, new research reveals. 

Known as TriSb92 (brand name Covidin, from drugmaker Pandemblock Oy in Finland), the viral inhibitor also appears effective against all coronavirus variants of concern, neutralizing even the Omicron variants BA.5, XBB, and BQ.1.1 in laboratory and mice studies. 

Unlike a COVID vaccine that boosts a person’s immune system as protection, the antiviral nasal spray works more directly by blocking the virus, acting as a “biological mask in the nasal cavity,” according to the biotechnology company set up to develop the treatment. 

The product targets a stable site on the spike protein of the virus that is not known to mutate. This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note.

“In animal models, by directly inactivating the virus, TriSb92 offers immediate and robust protection” against coronavirus infection and severe COVID, said Anna R. Mäkelä, PhD, lead author of the study and a senior scientist in the department of virology at the University of Helsinki. 

The study was published online in Nature Communications.
 

A potential first line of defense

Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. This could happen by limiting how much virus could replicate early in the skin inside the nose and nasopharynx (the upper part of the throat), said Dr. Mäkelä, who is also CEO of Pandemblock Oy, the company set up to develop the product.

“TriSb92 could effectively tip the balance in favor of the [the person] and thereby help to reduce the risk of severe COVID-19 disease,” she said. 

The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine.

“Many elderly people as well as individuals who are immunodeficient for various reasons do not respond to vaccines and are in the need of other protective measures,” said Kalle Saksela, MD, PhD, senior author of the study and a virologist at the University of Helsinki.
 

Multiple doses needed? 

TriSb92 is “one of multiple nasal spray approaches but unlikely to be as durable as effective nasal vaccines,” said Eric Topol, MD, a professor of molecular medicine and executive vice president of Scripps Research in La Jolla, Calif. Dr. Topol is also editor-in-chief of Medscape, WebMD’s sister site for medical professionals.

“The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months,” he said.

“Both have the allure of being variant-proof,” Dr. Topol added. 
 

Thinking small

Many laboratories are shifting from treatments using monoclonal antibodies to treatments using smaller antibody fragments called “nanobodies” because they are more cost-effective and are able to last longer in storage, Dr. Mäkelä and colleagues noted. 

Several of these nanobodies have shown promise against viruses in cell culture or animal models, including as an intranasal preventive treatment for SARS-CoV-2. 

One of these smaller antibodies is being developed from llamas for example; another comes from experiments with yeast to develop synthetic nanobodies; and in a third case, researchers isolated nanobodies from llamas and from mice and showed they could neutralize the SARS-CoV-2 virus.

These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). The RBD is where the coronavirus attaches to cells in the body. These agents essentially trick the virus by changing the structure of the outside of cells, so they look like a virus has already fused to them. This way, the virus moves on. 
 

Key findings

The researchers compared mice treated with TriSb92 before and after exposure to SARS-CoV-2. When given in advance, none of the treated mice had SARS-CoV-2 RNA in their lungs, while untreated mice in the comparison group had “abundant” levels.

Other evidence of viral infection showed similar differences between treated and untreated mice in the protective lining of cells called the epithelium inside the nose, nasal mucosa, and airways. 

Similarly, when given 2 or 4 hours after SARS-CoV-2 had already infected the epithelium, TriSb92 was linked to a complete lack of the virus’s RNA in the lungs.

It was more effective against the virus, though, when given before infection rather than after, “perhaps due to the initial establishment of the infection,” the researchers note.

The company led by Dr. Mäkelä is now working to secure funding for clinical trials of TriSb92 in humans. 

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

An antiviral therapy in early development has the potential to prevent COVID-19 infections when given as a nasal spray as little as 4 hours before exposure. It also appears to work as a treatment if used within 4 hours after infection inside the nose, new research reveals. 

Known as TriSb92 (brand name Covidin, from drugmaker Pandemblock Oy in Finland), the viral inhibitor also appears effective against all coronavirus variants of concern, neutralizing even the Omicron variants BA.5, XBB, and BQ.1.1 in laboratory and mice studies. 

Unlike a COVID vaccine that boosts a person’s immune system as protection, the antiviral nasal spray works more directly by blocking the virus, acting as a “biological mask in the nasal cavity,” according to the biotechnology company set up to develop the treatment. 

The product targets a stable site on the spike protein of the virus that is not known to mutate. This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note.

“In animal models, by directly inactivating the virus, TriSb92 offers immediate and robust protection” against coronavirus infection and severe COVID, said Anna R. Mäkelä, PhD, lead author of the study and a senior scientist in the department of virology at the University of Helsinki. 

The study was published online in Nature Communications.
 

A potential first line of defense

Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. This could happen by limiting how much virus could replicate early in the skin inside the nose and nasopharynx (the upper part of the throat), said Dr. Mäkelä, who is also CEO of Pandemblock Oy, the company set up to develop the product.

“TriSb92 could effectively tip the balance in favor of the [the person] and thereby help to reduce the risk of severe COVID-19 disease,” she said. 

The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine.

“Many elderly people as well as individuals who are immunodeficient for various reasons do not respond to vaccines and are in the need of other protective measures,” said Kalle Saksela, MD, PhD, senior author of the study and a virologist at the University of Helsinki.
 

Multiple doses needed? 

TriSb92 is “one of multiple nasal spray approaches but unlikely to be as durable as effective nasal vaccines,” said Eric Topol, MD, a professor of molecular medicine and executive vice president of Scripps Research in La Jolla, Calif. Dr. Topol is also editor-in-chief of Medscape, WebMD’s sister site for medical professionals.

“The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months,” he said.

“Both have the allure of being variant-proof,” Dr. Topol added. 
 

Thinking small

Many laboratories are shifting from treatments using monoclonal antibodies to treatments using smaller antibody fragments called “nanobodies” because they are more cost-effective and are able to last longer in storage, Dr. Mäkelä and colleagues noted. 

Several of these nanobodies have shown promise against viruses in cell culture or animal models, including as an intranasal preventive treatment for SARS-CoV-2. 

One of these smaller antibodies is being developed from llamas for example; another comes from experiments with yeast to develop synthetic nanobodies; and in a third case, researchers isolated nanobodies from llamas and from mice and showed they could neutralize the SARS-CoV-2 virus.

These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). The RBD is where the coronavirus attaches to cells in the body. These agents essentially trick the virus by changing the structure of the outside of cells, so they look like a virus has already fused to them. This way, the virus moves on. 
 

Key findings

The researchers compared mice treated with TriSb92 before and after exposure to SARS-CoV-2. When given in advance, none of the treated mice had SARS-CoV-2 RNA in their lungs, while untreated mice in the comparison group had “abundant” levels.

Other evidence of viral infection showed similar differences between treated and untreated mice in the protective lining of cells called the epithelium inside the nose, nasal mucosa, and airways. 

Similarly, when given 2 or 4 hours after SARS-CoV-2 had already infected the epithelium, TriSb92 was linked to a complete lack of the virus’s RNA in the lungs.

It was more effective against the virus, though, when given before infection rather than after, “perhaps due to the initial establishment of the infection,” the researchers note.

The company led by Dr. Mäkelä is now working to secure funding for clinical trials of TriSb92 in humans. 

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

An antiviral therapy in early development has the potential to prevent COVID-19 infections when given as a nasal spray as little as 4 hours before exposure. It also appears to work as a treatment if used within 4 hours after infection inside the nose, new research reveals. 

Known as TriSb92 (brand name Covidin, from drugmaker Pandemblock Oy in Finland), the viral inhibitor also appears effective against all coronavirus variants of concern, neutralizing even the Omicron variants BA.5, XBB, and BQ.1.1 in laboratory and mice studies. 

Unlike a COVID vaccine that boosts a person’s immune system as protection, the antiviral nasal spray works more directly by blocking the virus, acting as a “biological mask in the nasal cavity,” according to the biotechnology company set up to develop the treatment. 

The product targets a stable site on the spike protein of the virus that is not known to mutate. This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note.

“In animal models, by directly inactivating the virus, TriSb92 offers immediate and robust protection” against coronavirus infection and severe COVID, said Anna R. Mäkelä, PhD, lead author of the study and a senior scientist in the department of virology at the University of Helsinki. 

The study was published online in Nature Communications.
 

A potential first line of defense

Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. This could happen by limiting how much virus could replicate early in the skin inside the nose and nasopharynx (the upper part of the throat), said Dr. Mäkelä, who is also CEO of Pandemblock Oy, the company set up to develop the product.

“TriSb92 could effectively tip the balance in favor of the [the person] and thereby help to reduce the risk of severe COVID-19 disease,” she said. 

The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine.

“Many elderly people as well as individuals who are immunodeficient for various reasons do not respond to vaccines and are in the need of other protective measures,” said Kalle Saksela, MD, PhD, senior author of the study and a virologist at the University of Helsinki.
 

Multiple doses needed? 

TriSb92 is “one of multiple nasal spray approaches but unlikely to be as durable as effective nasal vaccines,” said Eric Topol, MD, a professor of molecular medicine and executive vice president of Scripps Research in La Jolla, Calif. Dr. Topol is also editor-in-chief of Medscape, WebMD’s sister site for medical professionals.

“The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months,” he said.

“Both have the allure of being variant-proof,” Dr. Topol added. 
 

Thinking small

Many laboratories are shifting from treatments using monoclonal antibodies to treatments using smaller antibody fragments called “nanobodies” because they are more cost-effective and are able to last longer in storage, Dr. Mäkelä and colleagues noted. 

Several of these nanobodies have shown promise against viruses in cell culture or animal models, including as an intranasal preventive treatment for SARS-CoV-2. 

One of these smaller antibodies is being developed from llamas for example; another comes from experiments with yeast to develop synthetic nanobodies; and in a third case, researchers isolated nanobodies from llamas and from mice and showed they could neutralize the SARS-CoV-2 virus.

These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). The RBD is where the coronavirus attaches to cells in the body. These agents essentially trick the virus by changing the structure of the outside of cells, so they look like a virus has already fused to them. This way, the virus moves on. 
 

Key findings

The researchers compared mice treated with TriSb92 before and after exposure to SARS-CoV-2. When given in advance, none of the treated mice had SARS-CoV-2 RNA in their lungs, while untreated mice in the comparison group had “abundant” levels.

Other evidence of viral infection showed similar differences between treated and untreated mice in the protective lining of cells called the epithelium inside the nose, nasal mucosa, and airways. 

Similarly, when given 2 or 4 hours after SARS-CoV-2 had already infected the epithelium, TriSb92 was linked to a complete lack of the virus’s RNA in the lungs.

It was more effective against the virus, though, when given before infection rather than after, “perhaps due to the initial establishment of the infection,” the researchers note.

The company led by Dr. Mäkelä is now working to secure funding for clinical trials of TriSb92 in humans. 

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

During 2 days of hearings on potential modifications to the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy (REMS), there was much agreement among dermatologists, industry representatives, and Food and Drug Administration representatives that provider and patient burdens persist after the chaotic rollout of the new REMS platform at the end of 2021.

On March 29, at the end of the FDA’s joint meeting of two advisory committees that addressed ways to improve the iPLEDGE program, most panelists voted to change the 19-day lockout period for patients who can become pregnant, and the requirement that every month, providers must document counseling of those who cannot get pregnant and are taking the drug for acne.

However, there was no consensus on whether there should be a lockout at all or for how long, and what an appropriate interval for counseling those who cannot get pregnant would be, if not monthly. Those voting on the questions repeatedly cited a lack of data to make well-informed decisions.

The meeting of the two panels, the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, was held March 28-29, to discuss proposed changes to iPLEDGE requirements, to minimize the program’s burden on patients, prescribers, and pharmacies – while maintaining safe use of the highly teratogenic drug.

Lockout based on outdated reasoning

John S. Barbieri, MD, a dermatologist and epidemiologist, and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston, speaking as deputy chair of the American Academy of Dermatology Association (AADA) iPLEDGE work group, described the burden of getting the drug to patients. He was not on the panel, but spoke during the open public hearing.

“Compared to other acne medications, the time it takes to successfully go from prescribed (isotretinoin) to when the patient actually has it in their hands is 5- to 10-fold higher,” he said.

Many don’t have a monthly cycle

But Dr. Barbieri said that reasoning is outdated.

“The current program’s focus on the menstrual cycle is really an antiquated approach,” he said. “Many patients do not have a monthly cycle due to medical conditions like polycystic ovarian syndrome, or due to [certain kinds of] contraception.”

He added, “By removing this 19-day lockout and, really, the archaic timing around the menstrual cycle in general in this program, we can simplify the program, improve it, and better align it with the real-world biology of our patients.” He added that patients are often missing the 7-day window for picking up their prescriptions through no fault of their own. Speakers at the hearing also mentioned insurance hassles and ordering delays.


 

Communication with IPMG

Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and outgoing chair of the AADA iPLEDGE work group, cited difficulty in working with IPMG on modifications as another barrier. She also spoke during the open public hearing.

UCSF

“Despite many, many attempts to work with the IPMG, we are not aware of any organizational structure or key leaders to communicate with. Instead we have been given repeatedly a generic email address for trying to establish a working relationship and we believe this may explain the inaction of the IPMG since our proposals 4 years ago in 2019.”

Among those proposals, she said, were allowing telemedicine visits as part of the iPLEDGE REMS program and reducing counseling attestation to every 6 months instead of monthly for those who cannot become pregnant.

She pointed to the chaotic rollout of modifications to the iPLEDGE program on a new website at the end of 2021.

In 2021, she said, “despite 6 months of notification, no prescriber input was solicited before revamping the website. This lack of transparency and accountability has been a major hurdle in improving iPLEDGE.”

Dr. Barbieri called the rollout “a debacle” that could have been mitigated with communication with IPMG. “We warned about every issue that happened and talked about ways to mitigate it and were largely ignored,” he said.

“By including dermatologists and key stakeholders in these discussions, as we move forward with changes to improve this program, we can make sure that it’s patient-centered.”

IPMG did not address the specific complaints about the working relationship with the AADA workgroup at the meeting.
 

Monthly attestation for counseling patients who cannot get pregnant

Dr. Barbieri said the monthly requirement to counsel patients who cannot get pregnant and document that counseling unfairly burdens clinicians and patients. “We’re essentially asking patients to come in monthly just to tell them not to share their drugs [or] donate blood,” he said.

Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among the panel members voting not to continue the 19-day lockout.

“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”

IPMG representative Dr. Wedin, said, “while we cannot support eliminating or extending the confirmation interval to a year, the [iPLEDGE] sponsors are agreeable [to] a 120-day confirmation interval.”

He said that while an extension to 120 days would reduce burden on prescribers, it comes with the risk in reducing oversight by a certified iPLEDGE prescriber and potentially increasing the risk for drug sharing.

“A patient may be more likely to share their drug with another person the further along with therapy they get as their condition improves,” Dr. Wedin said.
 

Home pregnancy testing

The advisory groups were also tasked with discussing whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most committee members and those in the public hearing who spoke on the issue agreed that home tests should continue in an effort to increase access and decrease burden.

During the pandemic, iPLEDGE rules have been relaxed from having a pregnancy test done only at a Clinical Laboratory Improvement Amendments–certified laboratory.

Lindsey Crist, PharmD, a risk management analyst at the FDA, who presented the FDA review committee’s analysis, said that the FDA’s review committee recommends ending the allowance of home tests, citing insufficient data on use and the discovery of instances of falsification of pregnancy tests.

“One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results,” Dr. Crist said.

Dr. Crist added, however, that the review committee recommends allowing the tests to be done in a provider’s office as an alternative.
 

Workaround to avoid falsification

Advisory committee member Brian P. Green, DO, associate professor of dermatology at Penn State University, Hershey, Pa., spoke in support of home pregnancy tests.

“What we have people do for telemedicine is take the stick, write their name, write the date on it, and send a picture of that the same day as their visit,” he said. “That way we have the pregnancy test the same day. Allowing this to continue to happen at home is important. Bringing people in is burdensome and costly.”

Emmy Graber, MD, a dermatologist who practices in Boston, and a director of the American Acne and Rosacea Society (AARS), relayed an example of the burden for a patient using isotretinoin who lives 1.5 hours away from the dermatology office. She is able to meet the requirements of iPLEDGE only through telehealth.

Suggestions for improvement

At the end of the hearing, advisory committee members were asked to propose improvements to the iPLEDGE REMS program.

Dr. Green advocated for the addition of an iPLEDGE mobile app.

“Most people go to their phones rather than their computers, particularly teenagers and younger people,” he noted.

Advisory committee member Megha M. Tollefson, MD, professor of dermatology and pediatric and adolescent medicine at Mayo Clinic in Rochester, Minn., echoed the need for an iPLEDGE app.

The young patients getting isotretinoin “don’t respond to email, they don’t necessarily go onto web pages. If we’re going to be as effective as possible, it’s going to have to be through an app-based system.”

Dr. Tollefson said she would like to see patient counseling standardized through the app. “I think there’s a lot of variability in what counseling is given when it’s left to the individual prescriber or practice,” she said.
 

Exceptions for long-acting contraceptives?

Advisory committee member Abbey B. Berenson, MD, PhD, professor of obstetrics and gynecology at University of Texas Medical Branch in Galveston, said that patients taking long-acting reversible contraceptives (LARCs) may need to be considered differently when deciding the intervals for attestation or whether to have a lockout period.

“LARC methods’ rate of failure is extremely low,” she said. “While it is true, as it has been pointed out, that all methods can fail, when they’re over 99% effective, I think that we can treat those methods differently than we treat methods such as birth control pills or abstinence that fail far more often. That is one way we could minimize burden on the providers and the patients.”

She also suggested using members of the health care team other than physicians to complete counseling, such as a nurse or pharmacist.
 

Prescriptions for emergency contraception

Advisory committee member Sascha Dublin, MD, PhD, senior scientific investigator for Kaiser Permanente Washington Health Research Institute in Seattle, said most patients taking the drug who can get pregnant should get a prescription for emergency contraception at the time of the first isotretinoin prescription.

“They don’t have to buy it, but to make it available at the very beginning sets the expectation that it would be good to have in your medicine cabinet, particularly if the [contraception] choice is abstinence or birth control pills.”

Dr. Dublin also called for better transparency surrounding the role of IPMG.

She said IPMG should be expected to collect data in a way that allows examination of health disparities, including by race and ethnicity and insurance status. Dr. Dublin added that she was concerned about the poor communication between dermatological societies and IPMG.

“The FDA should really require that IPMG hold periodic, regularly scheduled stakeholder forums,” she said. “There has to be a mechanism in place for IPMG to listen to those concerns in real time and respond.”

The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.

During 2 days of hearings on potential modifications to the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy (REMS), there was much agreement among dermatologists, industry representatives, and Food and Drug Administration representatives that provider and patient burdens persist after the chaotic rollout of the new REMS platform at the end of 2021.

On March 29, at the end of the FDA’s joint meeting of two advisory committees that addressed ways to improve the iPLEDGE program, most panelists voted to change the 19-day lockout period for patients who can become pregnant, and the requirement that every month, providers must document counseling of those who cannot get pregnant and are taking the drug for acne.

However, there was no consensus on whether there should be a lockout at all or for how long, and what an appropriate interval for counseling those who cannot get pregnant would be, if not monthly. Those voting on the questions repeatedly cited a lack of data to make well-informed decisions.

The meeting of the two panels, the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, was held March 28-29, to discuss proposed changes to iPLEDGE requirements, to minimize the program’s burden on patients, prescribers, and pharmacies – while maintaining safe use of the highly teratogenic drug.

Lockout based on outdated reasoning

John S. Barbieri, MD, a dermatologist and epidemiologist, and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston, speaking as deputy chair of the American Academy of Dermatology Association (AADA) iPLEDGE work group, described the burden of getting the drug to patients. He was not on the panel, but spoke during the open public hearing.

“Compared to other acne medications, the time it takes to successfully go from prescribed (isotretinoin) to when the patient actually has it in their hands is 5- to 10-fold higher,” he said.

Many don’t have a monthly cycle

But Dr. Barbieri said that reasoning is outdated.

“The current program’s focus on the menstrual cycle is really an antiquated approach,” he said. “Many patients do not have a monthly cycle due to medical conditions like polycystic ovarian syndrome, or due to [certain kinds of] contraception.”

He added, “By removing this 19-day lockout and, really, the archaic timing around the menstrual cycle in general in this program, we can simplify the program, improve it, and better align it with the real-world biology of our patients.” He added that patients are often missing the 7-day window for picking up their prescriptions through no fault of their own. Speakers at the hearing also mentioned insurance hassles and ordering delays.


 

Communication with IPMG

Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and outgoing chair of the AADA iPLEDGE work group, cited difficulty in working with IPMG on modifications as another barrier. She also spoke during the open public hearing.

UCSF

“Despite many, many attempts to work with the IPMG, we are not aware of any organizational structure or key leaders to communicate with. Instead we have been given repeatedly a generic email address for trying to establish a working relationship and we believe this may explain the inaction of the IPMG since our proposals 4 years ago in 2019.”

Among those proposals, she said, were allowing telemedicine visits as part of the iPLEDGE REMS program and reducing counseling attestation to every 6 months instead of monthly for those who cannot become pregnant.

She pointed to the chaotic rollout of modifications to the iPLEDGE program on a new website at the end of 2021.

In 2021, she said, “despite 6 months of notification, no prescriber input was solicited before revamping the website. This lack of transparency and accountability has been a major hurdle in improving iPLEDGE.”

Dr. Barbieri called the rollout “a debacle” that could have been mitigated with communication with IPMG. “We warned about every issue that happened and talked about ways to mitigate it and were largely ignored,” he said.

“By including dermatologists and key stakeholders in these discussions, as we move forward with changes to improve this program, we can make sure that it’s patient-centered.”

IPMG did not address the specific complaints about the working relationship with the AADA workgroup at the meeting.
 

Monthly attestation for counseling patients who cannot get pregnant

Dr. Barbieri said the monthly requirement to counsel patients who cannot get pregnant and document that counseling unfairly burdens clinicians and patients. “We’re essentially asking patients to come in monthly just to tell them not to share their drugs [or] donate blood,” he said.

Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among the panel members voting not to continue the 19-day lockout.

“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”

IPMG representative Dr. Wedin, said, “while we cannot support eliminating or extending the confirmation interval to a year, the [iPLEDGE] sponsors are agreeable [to] a 120-day confirmation interval.”

He said that while an extension to 120 days would reduce burden on prescribers, it comes with the risk in reducing oversight by a certified iPLEDGE prescriber and potentially increasing the risk for drug sharing.

“A patient may be more likely to share their drug with another person the further along with therapy they get as their condition improves,” Dr. Wedin said.
 

Home pregnancy testing

The advisory groups were also tasked with discussing whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most committee members and those in the public hearing who spoke on the issue agreed that home tests should continue in an effort to increase access and decrease burden.

During the pandemic, iPLEDGE rules have been relaxed from having a pregnancy test done only at a Clinical Laboratory Improvement Amendments–certified laboratory.

Lindsey Crist, PharmD, a risk management analyst at the FDA, who presented the FDA review committee’s analysis, said that the FDA’s review committee recommends ending the allowance of home tests, citing insufficient data on use and the discovery of instances of falsification of pregnancy tests.

“One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results,” Dr. Crist said.

Dr. Crist added, however, that the review committee recommends allowing the tests to be done in a provider’s office as an alternative.
 

Workaround to avoid falsification

Advisory committee member Brian P. Green, DO, associate professor of dermatology at Penn State University, Hershey, Pa., spoke in support of home pregnancy tests.

“What we have people do for telemedicine is take the stick, write their name, write the date on it, and send a picture of that the same day as their visit,” he said. “That way we have the pregnancy test the same day. Allowing this to continue to happen at home is important. Bringing people in is burdensome and costly.”

Emmy Graber, MD, a dermatologist who practices in Boston, and a director of the American Acne and Rosacea Society (AARS), relayed an example of the burden for a patient using isotretinoin who lives 1.5 hours away from the dermatology office. She is able to meet the requirements of iPLEDGE only through telehealth.

Suggestions for improvement

At the end of the hearing, advisory committee members were asked to propose improvements to the iPLEDGE REMS program.

Dr. Green advocated for the addition of an iPLEDGE mobile app.

“Most people go to their phones rather than their computers, particularly teenagers and younger people,” he noted.

Advisory committee member Megha M. Tollefson, MD, professor of dermatology and pediatric and adolescent medicine at Mayo Clinic in Rochester, Minn., echoed the need for an iPLEDGE app.

The young patients getting isotretinoin “don’t respond to email, they don’t necessarily go onto web pages. If we’re going to be as effective as possible, it’s going to have to be through an app-based system.”

Dr. Tollefson said she would like to see patient counseling standardized through the app. “I think there’s a lot of variability in what counseling is given when it’s left to the individual prescriber or practice,” she said.
 

Exceptions for long-acting contraceptives?

Advisory committee member Abbey B. Berenson, MD, PhD, professor of obstetrics and gynecology at University of Texas Medical Branch in Galveston, said that patients taking long-acting reversible contraceptives (LARCs) may need to be considered differently when deciding the intervals for attestation or whether to have a lockout period.

“LARC methods’ rate of failure is extremely low,” she said. “While it is true, as it has been pointed out, that all methods can fail, when they’re over 99% effective, I think that we can treat those methods differently than we treat methods such as birth control pills or abstinence that fail far more often. That is one way we could minimize burden on the providers and the patients.”

She also suggested using members of the health care team other than physicians to complete counseling, such as a nurse or pharmacist.
 

Prescriptions for emergency contraception

Advisory committee member Sascha Dublin, MD, PhD, senior scientific investigator for Kaiser Permanente Washington Health Research Institute in Seattle, said most patients taking the drug who can get pregnant should get a prescription for emergency contraception at the time of the first isotretinoin prescription.

“They don’t have to buy it, but to make it available at the very beginning sets the expectation that it would be good to have in your medicine cabinet, particularly if the [contraception] choice is abstinence or birth control pills.”

Dr. Dublin also called for better transparency surrounding the role of IPMG.

She said IPMG should be expected to collect data in a way that allows examination of health disparities, including by race and ethnicity and insurance status. Dr. Dublin added that she was concerned about the poor communication between dermatological societies and IPMG.

“The FDA should really require that IPMG hold periodic, regularly scheduled stakeholder forums,” she said. “There has to be a mechanism in place for IPMG to listen to those concerns in real time and respond.”

The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.

During 2 days of hearings on potential modifications to the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy (REMS), there was much agreement among dermatologists, industry representatives, and Food and Drug Administration representatives that provider and patient burdens persist after the chaotic rollout of the new REMS platform at the end of 2021.

On March 29, at the end of the FDA’s joint meeting of two advisory committees that addressed ways to improve the iPLEDGE program, most panelists voted to change the 19-day lockout period for patients who can become pregnant, and the requirement that every month, providers must document counseling of those who cannot get pregnant and are taking the drug for acne.

However, there was no consensus on whether there should be a lockout at all or for how long, and what an appropriate interval for counseling those who cannot get pregnant would be, if not monthly. Those voting on the questions repeatedly cited a lack of data to make well-informed decisions.

The meeting of the two panels, the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee, was held March 28-29, to discuss proposed changes to iPLEDGE requirements, to minimize the program’s burden on patients, prescribers, and pharmacies – while maintaining safe use of the highly teratogenic drug.

Lockout based on outdated reasoning

John S. Barbieri, MD, a dermatologist and epidemiologist, and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston, speaking as deputy chair of the American Academy of Dermatology Association (AADA) iPLEDGE work group, described the burden of getting the drug to patients. He was not on the panel, but spoke during the open public hearing.

“Compared to other acne medications, the time it takes to successfully go from prescribed (isotretinoin) to when the patient actually has it in their hands is 5- to 10-fold higher,” he said.

Many don’t have a monthly cycle

But Dr. Barbieri said that reasoning is outdated.

“The current program’s focus on the menstrual cycle is really an antiquated approach,” he said. “Many patients do not have a monthly cycle due to medical conditions like polycystic ovarian syndrome, or due to [certain kinds of] contraception.”

He added, “By removing this 19-day lockout and, really, the archaic timing around the menstrual cycle in general in this program, we can simplify the program, improve it, and better align it with the real-world biology of our patients.” He added that patients are often missing the 7-day window for picking up their prescriptions through no fault of their own. Speakers at the hearing also mentioned insurance hassles and ordering delays.


 

Communication with IPMG

Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and outgoing chair of the AADA iPLEDGE work group, cited difficulty in working with IPMG on modifications as another barrier. She also spoke during the open public hearing.

UCSF

“Despite many, many attempts to work with the IPMG, we are not aware of any organizational structure or key leaders to communicate with. Instead we have been given repeatedly a generic email address for trying to establish a working relationship and we believe this may explain the inaction of the IPMG since our proposals 4 years ago in 2019.”

Among those proposals, she said, were allowing telemedicine visits as part of the iPLEDGE REMS program and reducing counseling attestation to every 6 months instead of monthly for those who cannot become pregnant.

She pointed to the chaotic rollout of modifications to the iPLEDGE program on a new website at the end of 2021.

In 2021, she said, “despite 6 months of notification, no prescriber input was solicited before revamping the website. This lack of transparency and accountability has been a major hurdle in improving iPLEDGE.”

Dr. Barbieri called the rollout “a debacle” that could have been mitigated with communication with IPMG. “We warned about every issue that happened and talked about ways to mitigate it and were largely ignored,” he said.

“By including dermatologists and key stakeholders in these discussions, as we move forward with changes to improve this program, we can make sure that it’s patient-centered.”

IPMG did not address the specific complaints about the working relationship with the AADA workgroup at the meeting.
 

Monthly attestation for counseling patients who cannot get pregnant

Dr. Barbieri said the monthly requirement to counsel patients who cannot get pregnant and document that counseling unfairly burdens clinicians and patients. “We’re essentially asking patients to come in monthly just to tell them not to share their drugs [or] donate blood,” he said.

Ken Katz, MD, MSc, a dermatologist at Kaiser Permanente in San Francisco, was among the panel members voting not to continue the 19-day lockout.

“I think this places an unduly high burden physically and psychologically on our patients. It seems arbitrary,” he said. “Likely we will miss some pregnancies; we are missing some already. But the burden is not matched by the benefit.”

IPMG representative Dr. Wedin, said, “while we cannot support eliminating or extending the confirmation interval to a year, the [iPLEDGE] sponsors are agreeable [to] a 120-day confirmation interval.”

He said that while an extension to 120 days would reduce burden on prescribers, it comes with the risk in reducing oversight by a certified iPLEDGE prescriber and potentially increasing the risk for drug sharing.

“A patient may be more likely to share their drug with another person the further along with therapy they get as their condition improves,” Dr. Wedin said.
 

Home pregnancy testing

The advisory groups were also tasked with discussing whether home pregnancy tests, allowed during the COVID-19 public health emergency, should continue to be allowed. Most committee members and those in the public hearing who spoke on the issue agreed that home tests should continue in an effort to increase access and decrease burden.

During the pandemic, iPLEDGE rules have been relaxed from having a pregnancy test done only at a Clinical Laboratory Improvement Amendments–certified laboratory.

Lindsey Crist, PharmD, a risk management analyst at the FDA, who presented the FDA review committee’s analysis, said that the FDA’s review committee recommends ending the allowance of home tests, citing insufficient data on use and the discovery of instances of falsification of pregnancy tests.

“One study at an academic medical center reviewed the medical records of 89 patients who used home pregnancy tests while taking isotretinoin during the public health emergency. It found that 15.7% submitted falsified pregnancy test results,” Dr. Crist said.

Dr. Crist added, however, that the review committee recommends allowing the tests to be done in a provider’s office as an alternative.
 

Workaround to avoid falsification

Advisory committee member Brian P. Green, DO, associate professor of dermatology at Penn State University, Hershey, Pa., spoke in support of home pregnancy tests.

“What we have people do for telemedicine is take the stick, write their name, write the date on it, and send a picture of that the same day as their visit,” he said. “That way we have the pregnancy test the same day. Allowing this to continue to happen at home is important. Bringing people in is burdensome and costly.”

Emmy Graber, MD, a dermatologist who practices in Boston, and a director of the American Acne and Rosacea Society (AARS), relayed an example of the burden for a patient using isotretinoin who lives 1.5 hours away from the dermatology office. She is able to meet the requirements of iPLEDGE only through telehealth.

Suggestions for improvement

At the end of the hearing, advisory committee members were asked to propose improvements to the iPLEDGE REMS program.

Dr. Green advocated for the addition of an iPLEDGE mobile app.

“Most people go to their phones rather than their computers, particularly teenagers and younger people,” he noted.

Advisory committee member Megha M. Tollefson, MD, professor of dermatology and pediatric and adolescent medicine at Mayo Clinic in Rochester, Minn., echoed the need for an iPLEDGE app.

The young patients getting isotretinoin “don’t respond to email, they don’t necessarily go onto web pages. If we’re going to be as effective as possible, it’s going to have to be through an app-based system.”

Dr. Tollefson said she would like to see patient counseling standardized through the app. “I think there’s a lot of variability in what counseling is given when it’s left to the individual prescriber or practice,” she said.
 

Exceptions for long-acting contraceptives?

Advisory committee member Abbey B. Berenson, MD, PhD, professor of obstetrics and gynecology at University of Texas Medical Branch in Galveston, said that patients taking long-acting reversible contraceptives (LARCs) may need to be considered differently when deciding the intervals for attestation or whether to have a lockout period.

“LARC methods’ rate of failure is extremely low,” she said. “While it is true, as it has been pointed out, that all methods can fail, when they’re over 99% effective, I think that we can treat those methods differently than we treat methods such as birth control pills or abstinence that fail far more often. That is one way we could minimize burden on the providers and the patients.”

She also suggested using members of the health care team other than physicians to complete counseling, such as a nurse or pharmacist.
 

Prescriptions for emergency contraception

Advisory committee member Sascha Dublin, MD, PhD, senior scientific investigator for Kaiser Permanente Washington Health Research Institute in Seattle, said most patients taking the drug who can get pregnant should get a prescription for emergency contraception at the time of the first isotretinoin prescription.

“They don’t have to buy it, but to make it available at the very beginning sets the expectation that it would be good to have in your medicine cabinet, particularly if the [contraception] choice is abstinence or birth control pills.”

Dr. Dublin also called for better transparency surrounding the role of IPMG.

She said IPMG should be expected to collect data in a way that allows examination of health disparities, including by race and ethnicity and insurance status. Dr. Dublin added that she was concerned about the poor communication between dermatological societies and IPMG.

“The FDA should really require that IPMG hold periodic, regularly scheduled stakeholder forums,” she said. “There has to be a mechanism in place for IPMG to listen to those concerns in real time and respond.”

The advisory committees’ recommendations to the FDA are nonbinding, but the FDA generally follows the recommendations of advisory panels.

A couple of weeks ago I stumbled across a report of a Pew Research Center’s survey titled “Parenting in America today” (Pew Research Center. Jan. 24, 2023), which found that 40% of parents in the United States with children younger than 18 are “extremely or very worried” that at some point their children might struggle with anxiety or depression. Thirty-six percent replied that they were “somewhat” worried. This total of more than 75% represents a significant change from the 2015 Pew Center survey in which only 54% of parents were “somewhat” worried about their children’s mental health.

Prompted by these findings I began work on a column in which I planned to encourage pediatricians to think more like family physicians when we were working with children who were experiencing serious mental health problems. My primary message was going to be that we should turn more of our attention to the mental health of the anxious parents who must endure the often long and frustrating path toward effective psychiatric care for their children. This might come in the form of some simple suggestions about nonpharmacologic self-help strategies. Or, it could mean encouraging parents to seek psychiatric care or counseling for themselves as they wait for help for their child.

However, as I began that column, my thoughts kept drifting toward a broader consideration of the relationship between parents and pediatric mental health. If mental health of children is causing their parents to be anxious and depressed isn’t it just as likely that this is a bidirectional connection? This was not exactly an “aha” moment for me because it is a relationship I have considered for sometime. However, it is a concept that I have come to realize is receiving far too little attention.

There are exceptions. For example, a recent opinion piece in the New York Times by David French, “What if Kids Are Sad and Stressed Because Their Parents Are?” (March 19, 2023) echoes many of my concerns. Drawing on his experiences traveling around college campuses, Mr. French observes, “Just as parents are upset about their children’s anxiety and depression, children are anxious about their parent’s mental health.”

He notes that an August 2022 NBC News poll found that 58% of registered voters feel this country’s best days are behind it and joins me in imagining that this negative mind set is filtering down to the pediatric population. He acknowledges that there are other likely contributors to teen unhappiness including the ubiquity of smart phones, the secularization of society, and the media’s focus on the political divide. However, Mr. French wonders if the parenting style that results in childhood experiences that are dominated by adult supervision and protection may also be playing a large role.

In his conclusion, Mr. French asks us to consider “How much fear and anxiety should we import to our lives and homes?” as we adults search for an answer.

As I continued to drill down for other possible solutions, I encountered an avenue of psychological research that suggests that instead of, or in addition to, filtering out the anxiety-generating deluge of information, we begin to give some thought to how our beliefs may be coloring our perception of reality.

Jeremy D.W. Clifton, PhD, a psychologist at the University of Pennsylvania Positive Psychology Center has done extensive research on the relationship between our basic beliefs about the world (known as primal beliefs or simply primals in psychologist lingo) and how we interpret reality. For example, one of your primal beliefs may be that the world is a dangerous place. I, on the other hand, may see the world as a stimulating environment offering me endless opportunities to explore. I may see the world as an abundant resource limited only by my creativity. You, however, see it as a barren wasteland.

Dr. Clifton’s research has shown that our primals (at least those of adults) are relatively immutable through one’s lifetime and “do not appear to be the consequence of our experiences.” For example, living in a ZIP code with a high crime rate does not predict that you will see the world as a dangerous place. Nor does being affluent guarantee that an adult sees the world rich with opportunities.

It is unclear exactly when and by what process we develop our primal beliefs, but it is safe to say our parents probably play a large role. Exactly to what degree the tsunami of bad news we are allowing to inundate our children’s lives plays a role is unclear. However, it is reasonable to assume that news about climate change, school shootings, and the pandemic must be a contributor.

According to Dr. Clifton, there is some evidence that certain mind exercises, when applied diligently, can occasionally modify the primal beliefs of an individual who sees the world as dangerous and barren. Until such strategies become more readily accessible, the best we can do is acknowledge that our children are like canaries in a coal mine full of negative perceptions, then do our best to clear the air.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A couple of weeks ago I stumbled across a report of a Pew Research Center’s survey titled “Parenting in America today” (Pew Research Center. Jan. 24, 2023), which found that 40% of parents in the United States with children younger than 18 are “extremely or very worried” that at some point their children might struggle with anxiety or depression. Thirty-six percent replied that they were “somewhat” worried. This total of more than 75% represents a significant change from the 2015 Pew Center survey in which only 54% of parents were “somewhat” worried about their children’s mental health.

Prompted by these findings I began work on a column in which I planned to encourage pediatricians to think more like family physicians when we were working with children who were experiencing serious mental health problems. My primary message was going to be that we should turn more of our attention to the mental health of the anxious parents who must endure the often long and frustrating path toward effective psychiatric care for their children. This might come in the form of some simple suggestions about nonpharmacologic self-help strategies. Or, it could mean encouraging parents to seek psychiatric care or counseling for themselves as they wait for help for their child.

However, as I began that column, my thoughts kept drifting toward a broader consideration of the relationship between parents and pediatric mental health. If mental health of children is causing their parents to be anxious and depressed isn’t it just as likely that this is a bidirectional connection? This was not exactly an “aha” moment for me because it is a relationship I have considered for sometime. However, it is a concept that I have come to realize is receiving far too little attention.

There are exceptions. For example, a recent opinion piece in the New York Times by David French, “What if Kids Are Sad and Stressed Because Their Parents Are?” (March 19, 2023) echoes many of my concerns. Drawing on his experiences traveling around college campuses, Mr. French observes, “Just as parents are upset about their children’s anxiety and depression, children are anxious about their parent’s mental health.”

He notes that an August 2022 NBC News poll found that 58% of registered voters feel this country’s best days are behind it and joins me in imagining that this negative mind set is filtering down to the pediatric population. He acknowledges that there are other likely contributors to teen unhappiness including the ubiquity of smart phones, the secularization of society, and the media’s focus on the political divide. However, Mr. French wonders if the parenting style that results in childhood experiences that are dominated by adult supervision and protection may also be playing a large role.

In his conclusion, Mr. French asks us to consider “How much fear and anxiety should we import to our lives and homes?” as we adults search for an answer.

As I continued to drill down for other possible solutions, I encountered an avenue of psychological research that suggests that instead of, or in addition to, filtering out the anxiety-generating deluge of information, we begin to give some thought to how our beliefs may be coloring our perception of reality.

Jeremy D.W. Clifton, PhD, a psychologist at the University of Pennsylvania Positive Psychology Center has done extensive research on the relationship between our basic beliefs about the world (known as primal beliefs or simply primals in psychologist lingo) and how we interpret reality. For example, one of your primal beliefs may be that the world is a dangerous place. I, on the other hand, may see the world as a stimulating environment offering me endless opportunities to explore. I may see the world as an abundant resource limited only by my creativity. You, however, see it as a barren wasteland.

Dr. Clifton’s research has shown that our primals (at least those of adults) are relatively immutable through one’s lifetime and “do not appear to be the consequence of our experiences.” For example, living in a ZIP code with a high crime rate does not predict that you will see the world as a dangerous place. Nor does being affluent guarantee that an adult sees the world rich with opportunities.

It is unclear exactly when and by what process we develop our primal beliefs, but it is safe to say our parents probably play a large role. Exactly to what degree the tsunami of bad news we are allowing to inundate our children’s lives plays a role is unclear. However, it is reasonable to assume that news about climate change, school shootings, and the pandemic must be a contributor.

According to Dr. Clifton, there is some evidence that certain mind exercises, when applied diligently, can occasionally modify the primal beliefs of an individual who sees the world as dangerous and barren. Until such strategies become more readily accessible, the best we can do is acknowledge that our children are like canaries in a coal mine full of negative perceptions, then do our best to clear the air.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A couple of weeks ago I stumbled across a report of a Pew Research Center’s survey titled “Parenting in America today” (Pew Research Center. Jan. 24, 2023), which found that 40% of parents in the United States with children younger than 18 are “extremely or very worried” that at some point their children might struggle with anxiety or depression. Thirty-six percent replied that they were “somewhat” worried. This total of more than 75% represents a significant change from the 2015 Pew Center survey in which only 54% of parents were “somewhat” worried about their children’s mental health.

Prompted by these findings I began work on a column in which I planned to encourage pediatricians to think more like family physicians when we were working with children who were experiencing serious mental health problems. My primary message was going to be that we should turn more of our attention to the mental health of the anxious parents who must endure the often long and frustrating path toward effective psychiatric care for their children. This might come in the form of some simple suggestions about nonpharmacologic self-help strategies. Or, it could mean encouraging parents to seek psychiatric care or counseling for themselves as they wait for help for their child.

However, as I began that column, my thoughts kept drifting toward a broader consideration of the relationship between parents and pediatric mental health. If mental health of children is causing their parents to be anxious and depressed isn’t it just as likely that this is a bidirectional connection? This was not exactly an “aha” moment for me because it is a relationship I have considered for sometime. However, it is a concept that I have come to realize is receiving far too little attention.

There are exceptions. For example, a recent opinion piece in the New York Times by David French, “What if Kids Are Sad and Stressed Because Their Parents Are?” (March 19, 2023) echoes many of my concerns. Drawing on his experiences traveling around college campuses, Mr. French observes, “Just as parents are upset about their children’s anxiety and depression, children are anxious about their parent’s mental health.”

He notes that an August 2022 NBC News poll found that 58% of registered voters feel this country’s best days are behind it and joins me in imagining that this negative mind set is filtering down to the pediatric population. He acknowledges that there are other likely contributors to teen unhappiness including the ubiquity of smart phones, the secularization of society, and the media’s focus on the political divide. However, Mr. French wonders if the parenting style that results in childhood experiences that are dominated by adult supervision and protection may also be playing a large role.

In his conclusion, Mr. French asks us to consider “How much fear and anxiety should we import to our lives and homes?” as we adults search for an answer.

As I continued to drill down for other possible solutions, I encountered an avenue of psychological research that suggests that instead of, or in addition to, filtering out the anxiety-generating deluge of information, we begin to give some thought to how our beliefs may be coloring our perception of reality.

Jeremy D.W. Clifton, PhD, a psychologist at the University of Pennsylvania Positive Psychology Center has done extensive research on the relationship between our basic beliefs about the world (known as primal beliefs or simply primals in psychologist lingo) and how we interpret reality. For example, one of your primal beliefs may be that the world is a dangerous place. I, on the other hand, may see the world as a stimulating environment offering me endless opportunities to explore. I may see the world as an abundant resource limited only by my creativity. You, however, see it as a barren wasteland.

Dr. Clifton’s research has shown that our primals (at least those of adults) are relatively immutable through one’s lifetime and “do not appear to be the consequence of our experiences.” For example, living in a ZIP code with a high crime rate does not predict that you will see the world as a dangerous place. Nor does being affluent guarantee that an adult sees the world rich with opportunities.

It is unclear exactly when and by what process we develop our primal beliefs, but it is safe to say our parents probably play a large role. Exactly to what degree the tsunami of bad news we are allowing to inundate our children’s lives plays a role is unclear. However, it is reasonable to assume that news about climate change, school shootings, and the pandemic must be a contributor.

According to Dr. Clifton, there is some evidence that certain mind exercises, when applied diligently, can occasionally modify the primal beliefs of an individual who sees the world as dangerous and barren. Until such strategies become more readily accessible, the best we can do is acknowledge that our children are like canaries in a coal mine full of negative perceptions, then do our best to clear the air.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The biased discourse and double standards around antiobesity glucagon-like peptide 1 (GLP-1) receptor agonists continue apace, most recently in The New England Journal of Medicine (NEJM) where some economists opined that their coverage would be disastrous for Medicare.

Among their concerns? The drugs need to be taken long term (just like drugs for any other chronic condition). The new drugs are more expensive than the old drugs (just like new drugs for any other chronic condition). Lots of people will want to take them (just like highly effective drugs for any other chronic condition that has a significant quality-of-life or clinical impact). The U.K. recommended that they be covered only for 2 years (unlike drugs for any other chronic condition). And the Institute for Clinical and Economic Review (ICER) on which they lean heavily decided that $13,618 annually was too expensive for a medication that leads to sustained 15%-20% weight losses and those losses’ consequential benefits.

As a clinician working with patients who sustain those levels of weight loss, I find that conclusion confusing. Whether by way of lifestyle alone, or more often by way of lifestyle efforts plus medication or lifestyle efforts plus surgery, the benefits reported and seen with 15%-20% weight losses are almost uniformly huge. Patients are regularly seen discontinuing or reducing the dosage of multiple medications as a result of improvements to multiple weight-responsive comorbidities, and they also report objective benefits to mood, sleep, mobility, pain, and energy. Losing that much weight changes lives. Not to mention the impact that that degree of loss has on the primary prevention of so many diseases, including plausible reductions in many common cancers – reductions that have been shown to occur after surgery-related weight losses and for which there’s no plausible reason to imagine that they wouldn’t occur with pharmaceutical-related losses.

Are those discussions found in the NEJM op-ed or in the ICER report? Well, yes, sort of. However, in the NEJM op-ed, the word “prevention” isn’t used once, and unlike with oral hypoglycemics or antihypertensives, the authors state that with antiobesity medications, additional research is needed to determine whether medication-induced changes to A1c, blood pressure, and waist circumference would have clinical benefits: “Antiobesity medications have been shown to improve the surrogate end points of weight, glycated hemoglobin levels, systolic blood pressure, and waist circumference. Long-term studies are needed, however, to clarify how medication-induced changes in these surrogate markers translate to health outcomes.”

Primary prevention is mentioned in the ICER review, but in the “limitations” section where the authors explain that they didn’t include it in their modeling: “The long-term benefits of preventing other comorbidities including cancer, chronic kidney disease, osteoarthritis, and sleep apnea were not explicitly modeled in the base case.”

And they pretended that the impact on existing weight-responsive comorbidities mostly didn’t exist, too: “To limit the complexity of the cost-effectiveness model and to prevent double-counting of treatment benefits, we limited the long-term effects of treatments for weight management to cardiovascular risk and delays in the onset and/or diagnosis of diabetes mellitus.”

As far as cardiovascular disease (CVD) benefits go, you might have thought that it would be a slam dunk on that basis alone, at least according to a recent simple back-of-the-envelope math exercise presented at a recent American College of Cardiology conference, which applied the semaglutide treatment group weight changes in the STEP 1 trial to estimate the population impact on weight and obesity in 30- to 74-year-olds without prior CVD, and estimated 10-year CVD risks utilizing the BMI-based Framingham CVD risk scores. By their accounting, semaglutide treatment in eligible American patients has the potential to prevent over 1.6 million CVD events over 10 years.

Finally, even putting aside ICER’s admittedly and exceedingly narrow base case, what lifestyle-alone studies could ICER possibly be comparing with drug efficacy? And what does “alone” mean? Does “alone” mean with a months- or years long interprofessional behavioral program? Does “alone” mean by way of diet books? Does “alone” mean by way of simply “moving more and eating less”? I’m not aware of robust studies demonstrating any long-term meaningful, predictable, reproducible, durable weight loss outcomes for any lifestyle-only approach, intensive or otherwise.

It’s difficult for me to imagine a situation in which a drug other than an antiobesity drug would be found to have too many benefits to include in your cost-effectiveness analysis but where you’d be comfortable to run that analysis anyhow, and then come out against the drug’s recommendation and fearmonger about its use.

But then again, systemic weight bias is a hell of a drug.
 

Dr. Freedhoff is associate professor, department of family medicine, University of Ottawa, and medical director, Bariatric Medical Institute, Ottawa. He disclosed ties with Constant Health and Novo Nordisk, and has shared opinions via Weighty Matters and social media.

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

The biased discourse and double standards around antiobesity glucagon-like peptide 1 (GLP-1) receptor agonists continue apace, most recently in The New England Journal of Medicine (NEJM) where some economists opined that their coverage would be disastrous for Medicare.

Among their concerns? The drugs need to be taken long term (just like drugs for any other chronic condition). The new drugs are more expensive than the old drugs (just like new drugs for any other chronic condition). Lots of people will want to take them (just like highly effective drugs for any other chronic condition that has a significant quality-of-life or clinical impact). The U.K. recommended that they be covered only for 2 years (unlike drugs for any other chronic condition). And the Institute for Clinical and Economic Review (ICER) on which they lean heavily decided that $13,618 annually was too expensive for a medication that leads to sustained 15%-20% weight losses and those losses’ consequential benefits.

As a clinician working with patients who sustain those levels of weight loss, I find that conclusion confusing. Whether by way of lifestyle alone, or more often by way of lifestyle efforts plus medication or lifestyle efforts plus surgery, the benefits reported and seen with 15%-20% weight losses are almost uniformly huge. Patients are regularly seen discontinuing or reducing the dosage of multiple medications as a result of improvements to multiple weight-responsive comorbidities, and they also report objective benefits to mood, sleep, mobility, pain, and energy. Losing that much weight changes lives. Not to mention the impact that that degree of loss has on the primary prevention of so many diseases, including plausible reductions in many common cancers – reductions that have been shown to occur after surgery-related weight losses and for which there’s no plausible reason to imagine that they wouldn’t occur with pharmaceutical-related losses.

Are those discussions found in the NEJM op-ed or in the ICER report? Well, yes, sort of. However, in the NEJM op-ed, the word “prevention” isn’t used once, and unlike with oral hypoglycemics or antihypertensives, the authors state that with antiobesity medications, additional research is needed to determine whether medication-induced changes to A1c, blood pressure, and waist circumference would have clinical benefits: “Antiobesity medications have been shown to improve the surrogate end points of weight, glycated hemoglobin levels, systolic blood pressure, and waist circumference. Long-term studies are needed, however, to clarify how medication-induced changes in these surrogate markers translate to health outcomes.”

Primary prevention is mentioned in the ICER review, but in the “limitations” section where the authors explain that they didn’t include it in their modeling: “The long-term benefits of preventing other comorbidities including cancer, chronic kidney disease, osteoarthritis, and sleep apnea were not explicitly modeled in the base case.”

And they pretended that the impact on existing weight-responsive comorbidities mostly didn’t exist, too: “To limit the complexity of the cost-effectiveness model and to prevent double-counting of treatment benefits, we limited the long-term effects of treatments for weight management to cardiovascular risk and delays in the onset and/or diagnosis of diabetes mellitus.”

As far as cardiovascular disease (CVD) benefits go, you might have thought that it would be a slam dunk on that basis alone, at least according to a recent simple back-of-the-envelope math exercise presented at a recent American College of Cardiology conference, which applied the semaglutide treatment group weight changes in the STEP 1 trial to estimate the population impact on weight and obesity in 30- to 74-year-olds without prior CVD, and estimated 10-year CVD risks utilizing the BMI-based Framingham CVD risk scores. By their accounting, semaglutide treatment in eligible American patients has the potential to prevent over 1.6 million CVD events over 10 years.

Finally, even putting aside ICER’s admittedly and exceedingly narrow base case, what lifestyle-alone studies could ICER possibly be comparing with drug efficacy? And what does “alone” mean? Does “alone” mean with a months- or years long interprofessional behavioral program? Does “alone” mean by way of diet books? Does “alone” mean by way of simply “moving more and eating less”? I’m not aware of robust studies demonstrating any long-term meaningful, predictable, reproducible, durable weight loss outcomes for any lifestyle-only approach, intensive or otherwise.

It’s difficult for me to imagine a situation in which a drug other than an antiobesity drug would be found to have too many benefits to include in your cost-effectiveness analysis but where you’d be comfortable to run that analysis anyhow, and then come out against the drug’s recommendation and fearmonger about its use.

But then again, systemic weight bias is a hell of a drug.
 

Dr. Freedhoff is associate professor, department of family medicine, University of Ottawa, and medical director, Bariatric Medical Institute, Ottawa. He disclosed ties with Constant Health and Novo Nordisk, and has shared opinions via Weighty Matters and social media.

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

The biased discourse and double standards around antiobesity glucagon-like peptide 1 (GLP-1) receptor agonists continue apace, most recently in The New England Journal of Medicine (NEJM) where some economists opined that their coverage would be disastrous for Medicare.

Among their concerns? The drugs need to be taken long term (just like drugs for any other chronic condition). The new drugs are more expensive than the old drugs (just like new drugs for any other chronic condition). Lots of people will want to take them (just like highly effective drugs for any other chronic condition that has a significant quality-of-life or clinical impact). The U.K. recommended that they be covered only for 2 years (unlike drugs for any other chronic condition). And the Institute for Clinical and Economic Review (ICER) on which they lean heavily decided that $13,618 annually was too expensive for a medication that leads to sustained 15%-20% weight losses and those losses’ consequential benefits.

As a clinician working with patients who sustain those levels of weight loss, I find that conclusion confusing. Whether by way of lifestyle alone, or more often by way of lifestyle efforts plus medication or lifestyle efforts plus surgery, the benefits reported and seen with 15%-20% weight losses are almost uniformly huge. Patients are regularly seen discontinuing or reducing the dosage of multiple medications as a result of improvements to multiple weight-responsive comorbidities, and they also report objective benefits to mood, sleep, mobility, pain, and energy. Losing that much weight changes lives. Not to mention the impact that that degree of loss has on the primary prevention of so many diseases, including plausible reductions in many common cancers – reductions that have been shown to occur after surgery-related weight losses and for which there’s no plausible reason to imagine that they wouldn’t occur with pharmaceutical-related losses.

Are those discussions found in the NEJM op-ed or in the ICER report? Well, yes, sort of. However, in the NEJM op-ed, the word “prevention” isn’t used once, and unlike with oral hypoglycemics or antihypertensives, the authors state that with antiobesity medications, additional research is needed to determine whether medication-induced changes to A1c, blood pressure, and waist circumference would have clinical benefits: “Antiobesity medications have been shown to improve the surrogate end points of weight, glycated hemoglobin levels, systolic blood pressure, and waist circumference. Long-term studies are needed, however, to clarify how medication-induced changes in these surrogate markers translate to health outcomes.”

Primary prevention is mentioned in the ICER review, but in the “limitations” section where the authors explain that they didn’t include it in their modeling: “The long-term benefits of preventing other comorbidities including cancer, chronic kidney disease, osteoarthritis, and sleep apnea were not explicitly modeled in the base case.”

And they pretended that the impact on existing weight-responsive comorbidities mostly didn’t exist, too: “To limit the complexity of the cost-effectiveness model and to prevent double-counting of treatment benefits, we limited the long-term effects of treatments for weight management to cardiovascular risk and delays in the onset and/or diagnosis of diabetes mellitus.”

As far as cardiovascular disease (CVD) benefits go, you might have thought that it would be a slam dunk on that basis alone, at least according to a recent simple back-of-the-envelope math exercise presented at a recent American College of Cardiology conference, which applied the semaglutide treatment group weight changes in the STEP 1 trial to estimate the population impact on weight and obesity in 30- to 74-year-olds without prior CVD, and estimated 10-year CVD risks utilizing the BMI-based Framingham CVD risk scores. By their accounting, semaglutide treatment in eligible American patients has the potential to prevent over 1.6 million CVD events over 10 years.

Finally, even putting aside ICER’s admittedly and exceedingly narrow base case, what lifestyle-alone studies could ICER possibly be comparing with drug efficacy? And what does “alone” mean? Does “alone” mean with a months- or years long interprofessional behavioral program? Does “alone” mean by way of diet books? Does “alone” mean by way of simply “moving more and eating less”? I’m not aware of robust studies demonstrating any long-term meaningful, predictable, reproducible, durable weight loss outcomes for any lifestyle-only approach, intensive or otherwise.

It’s difficult for me to imagine a situation in which a drug other than an antiobesity drug would be found to have too many benefits to include in your cost-effectiveness analysis but where you’d be comfortable to run that analysis anyhow, and then come out against the drug’s recommendation and fearmonger about its use.

But then again, systemic weight bias is a hell of a drug.
 

Dr. Freedhoff is associate professor, department of family medicine, University of Ottawa, and medical director, Bariatric Medical Institute, Ottawa. He disclosed ties with Constant Health and Novo Nordisk, and has shared opinions via Weighty Matters and social media.

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

You are seeing a 28-year-old man for a same-day appointment. He has a history of opioid use disorder and chronic hepatitis C virus infection. He has been using injections of heroin and fentanyl for more than 6 years, and you can see in his medical record that he has had four outpatient appointments for cutaneous infections along with three emergency department visits for same in the past 2 years. His chief complaint today is pain over his left forearm for the past 3 days. He does not report fever or other constitutional symptoms.

Examination of the left forearm reveals 8 cm of erythema with induration and calor but no fluctuance. The area is moderately tender to palpation. He has no other abnormal findings on exam.

What’s your course of action?
 

Dr. Vega’s take

You want to treat this patient with antibiotics and close follow-up, and you note that he has a history of penicillin allergy. A note in his record states that he had a rash after receiving amoxicillin as a child.

Sometimes, we have to take the most expedient action in health care. But most of the time, we should do the right thing, even if it’s harder. I would gather more history of this reaction to penicillin and consider an oral challenge, hoping that the work that we put in to testing him for penicillin allergy pays dividends for him now and for years to come.

Penicillin allergy is very commonly listed in patient health records. In a retrospective analysis of the charts of 11,761 patients seen at a single U.S. urban outpatient system in 2012, 11.5% had documentation of penicillin allergy. Rash was the most common manifestation listed for allergy (37% of cases), followed by unknown symptoms (20%), hives (19%), swelling/angioedema (12%), and anaphylaxis (7%). Women were nearly twice as likely as men were to report a history of penicillin allergy, and patients of Asian descent had half the reported prevalence of penicillin allergy, compared with White patients.

Only 6% of the patients reporting penicillin allergy in this study had been referred to an allergy specialist. Given the consequences of true penicillin allergy, this rate is far too low. Patients with a history of penicillin allergy have higher risks for mortality from coexisting hematologic malignancies and penicillin-sensitive infections such as Staphylococcus species. They more frequently develop resistance to multiple antimicrobials and have longer average lengths of stay in the hospital.

Getting a good history for penicillin allergy can be challenging. Approximately three-quarters of penicillin allergies are diagnosed prior to age 3 years. Some children with a family history of penicillin allergy are mislabeled as having an active allergy, even though family history is not a significant contributor to penicillin allergy. Most rashes blamed on penicillin among children are actually not immunoglobulin (Ig) E–mediated and instead represent viral exanthems.

In response to these challenges, at the end of 2022, the American Academy of Allergy, Asthma & Immunology along with the American College of Allergy, Asthma and Immunology published new recommendations for the management of drug allergy. These recommendations provide an algorithm for the active reassessment of penicillin allergy. Like other recommendations in recent years, they call for a proactive approach in questioning the potential clinical consequences of the penicillin allergy listed in the health record.

First, the guidelines recommend against needing any testing for previous adverse reactions to penicillin, such as headache, nausea/vomiting, or diarrhea, that are not IgE-mediated. However, patients who have experienced these adverse reactions may still be reticent to take penicillin. For them and for adults with a history of mild to moderate reactions to penicillin more than 5 years ago, a single oral challenge test with amoxicillin is practical and can be used to exclude penicillin allergy.
 

The oral amoxicillin challenge

After patients take a treatment dose of oral amoxicillin, they should be observed for 1 hour for any objective reaction. The clinical setting should be able to support patients in the rare case of a more severe reaction to penicillin. Subjective symptoms such as pruritus without objective findings such as rash may be considered a successful challenge, and penicillin may be taken off the list of allergies. The treating team can bill CPT codes for drug challenge testing.

Some research has supported multidose testing with amoxicillin to assess for late reactions to a penicillin oral challenge, but the current guidelines recommend against this approach based on the very limited yield in finding additional cases of true allergy with extra doses of antibiotics. One method to address this issue is to have patients advise the practice if symptoms develop within 10 days of the oral challenge, with photos or prompt clinical evaluation to assess for an IgE-mediated reaction.

Many patients, and certainly some clinicians, will have significant trepidation regarding an oral challenge, despite the low risk for complications. For these patients, as well as children with a history of penicillin allergy and patients with a history of anaphylaxis to penicillin or probable IgE-mediated reaction to penicillin in the past several years, skin testing is recommended. Lower-risk patients might feel reassured to complete an oral challenge test after a negative skin test.

Penicillin skin testing is more reliable than a radioallergosorbent test or an enzyme-linked immunoassay and carries a high specificity. However, skin testing requires the specialized care of an allergy clinic, and this resource is limited in many communities.

Many patients will have negative oral challenge or skin testing for penicillin allergy, but there are still some critical responsibilities for the clinician after testing is complete. First, the label of penicillin allergy should be expunged from all available health records. Second, the clinician should communicate clearly and with empathy to the patient that they can take penicillin-based antibiotics safely and with confidence. Repeat testing is unnecessary unless new symptoms develop.

Given the millions of U.S. residents with penicillin allergy documented in the health record but limited resources for allergy testing, we all need to be engaged in proactively delabeling this allergy from patients who can take penicillin antibiotics without problems. But the application of this policy to clinical practice is challenging on several levels, from patient and clinician fear to practical constraints on time.

Dr. Vega is health sciences clinical professor, family medicine, University of California, Irvine. He has disclosed ties with McNeil Pharmaceuticals.

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

You are seeing a 28-year-old man for a same-day appointment. He has a history of opioid use disorder and chronic hepatitis C virus infection. He has been using injections of heroin and fentanyl for more than 6 years, and you can see in his medical record that he has had four outpatient appointments for cutaneous infections along with three emergency department visits for same in the past 2 years. His chief complaint today is pain over his left forearm for the past 3 days. He does not report fever or other constitutional symptoms.

Examination of the left forearm reveals 8 cm of erythema with induration and calor but no fluctuance. The area is moderately tender to palpation. He has no other abnormal findings on exam.

What’s your course of action?
 

Dr. Vega’s take

You want to treat this patient with antibiotics and close follow-up, and you note that he has a history of penicillin allergy. A note in his record states that he had a rash after receiving amoxicillin as a child.

Sometimes, we have to take the most expedient action in health care. But most of the time, we should do the right thing, even if it’s harder. I would gather more history of this reaction to penicillin and consider an oral challenge, hoping that the work that we put in to testing him for penicillin allergy pays dividends for him now and for years to come.

Penicillin allergy is very commonly listed in patient health records. In a retrospective analysis of the charts of 11,761 patients seen at a single U.S. urban outpatient system in 2012, 11.5% had documentation of penicillin allergy. Rash was the most common manifestation listed for allergy (37% of cases), followed by unknown symptoms (20%), hives (19%), swelling/angioedema (12%), and anaphylaxis (7%). Women were nearly twice as likely as men were to report a history of penicillin allergy, and patients of Asian descent had half the reported prevalence of penicillin allergy, compared with White patients.

Only 6% of the patients reporting penicillin allergy in this study had been referred to an allergy specialist. Given the consequences of true penicillin allergy, this rate is far too low. Patients with a history of penicillin allergy have higher risks for mortality from coexisting hematologic malignancies and penicillin-sensitive infections such as Staphylococcus species. They more frequently develop resistance to multiple antimicrobials and have longer average lengths of stay in the hospital.

Getting a good history for penicillin allergy can be challenging. Approximately three-quarters of penicillin allergies are diagnosed prior to age 3 years. Some children with a family history of penicillin allergy are mislabeled as having an active allergy, even though family history is not a significant contributor to penicillin allergy. Most rashes blamed on penicillin among children are actually not immunoglobulin (Ig) E–mediated and instead represent viral exanthems.

In response to these challenges, at the end of 2022, the American Academy of Allergy, Asthma & Immunology along with the American College of Allergy, Asthma and Immunology published new recommendations for the management of drug allergy. These recommendations provide an algorithm for the active reassessment of penicillin allergy. Like other recommendations in recent years, they call for a proactive approach in questioning the potential clinical consequences of the penicillin allergy listed in the health record.

First, the guidelines recommend against needing any testing for previous adverse reactions to penicillin, such as headache, nausea/vomiting, or diarrhea, that are not IgE-mediated. However, patients who have experienced these adverse reactions may still be reticent to take penicillin. For them and for adults with a history of mild to moderate reactions to penicillin more than 5 years ago, a single oral challenge test with amoxicillin is practical and can be used to exclude penicillin allergy.
 

The oral amoxicillin challenge

After patients take a treatment dose of oral amoxicillin, they should be observed for 1 hour for any objective reaction. The clinical setting should be able to support patients in the rare case of a more severe reaction to penicillin. Subjective symptoms such as pruritus without objective findings such as rash may be considered a successful challenge, and penicillin may be taken off the list of allergies. The treating team can bill CPT codes for drug challenge testing.

Some research has supported multidose testing with amoxicillin to assess for late reactions to a penicillin oral challenge, but the current guidelines recommend against this approach based on the very limited yield in finding additional cases of true allergy with extra doses of antibiotics. One method to address this issue is to have patients advise the practice if symptoms develop within 10 days of the oral challenge, with photos or prompt clinical evaluation to assess for an IgE-mediated reaction.

Many patients, and certainly some clinicians, will have significant trepidation regarding an oral challenge, despite the low risk for complications. For these patients, as well as children with a history of penicillin allergy and patients with a history of anaphylaxis to penicillin or probable IgE-mediated reaction to penicillin in the past several years, skin testing is recommended. Lower-risk patients might feel reassured to complete an oral challenge test after a negative skin test.

Penicillin skin testing is more reliable than a radioallergosorbent test or an enzyme-linked immunoassay and carries a high specificity. However, skin testing requires the specialized care of an allergy clinic, and this resource is limited in many communities.

Many patients will have negative oral challenge or skin testing for penicillin allergy, but there are still some critical responsibilities for the clinician after testing is complete. First, the label of penicillin allergy should be expunged from all available health records. Second, the clinician should communicate clearly and with empathy to the patient that they can take penicillin-based antibiotics safely and with confidence. Repeat testing is unnecessary unless new symptoms develop.

Given the millions of U.S. residents with penicillin allergy documented in the health record but limited resources for allergy testing, we all need to be engaged in proactively delabeling this allergy from patients who can take penicillin antibiotics without problems. But the application of this policy to clinical practice is challenging on several levels, from patient and clinician fear to practical constraints on time.

Dr. Vega is health sciences clinical professor, family medicine, University of California, Irvine. He has disclosed ties with McNeil Pharmaceuticals.

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

You are seeing a 28-year-old man for a same-day appointment. He has a history of opioid use disorder and chronic hepatitis C virus infection. He has been using injections of heroin and fentanyl for more than 6 years, and you can see in his medical record that he has had four outpatient appointments for cutaneous infections along with three emergency department visits for same in the past 2 years. His chief complaint today is pain over his left forearm for the past 3 days. He does not report fever or other constitutional symptoms.

Examination of the left forearm reveals 8 cm of erythema with induration and calor but no fluctuance. The area is moderately tender to palpation. He has no other abnormal findings on exam.

What’s your course of action?
 

Dr. Vega’s take

You want to treat this patient with antibiotics and close follow-up, and you note that he has a history of penicillin allergy. A note in his record states that he had a rash after receiving amoxicillin as a child.

Sometimes, we have to take the most expedient action in health care. But most of the time, we should do the right thing, even if it’s harder. I would gather more history of this reaction to penicillin and consider an oral challenge, hoping that the work that we put in to testing him for penicillin allergy pays dividends for him now and for years to come.

Penicillin allergy is very commonly listed in patient health records. In a retrospective analysis of the charts of 11,761 patients seen at a single U.S. urban outpatient system in 2012, 11.5% had documentation of penicillin allergy. Rash was the most common manifestation listed for allergy (37% of cases), followed by unknown symptoms (20%), hives (19%), swelling/angioedema (12%), and anaphylaxis (7%). Women were nearly twice as likely as men were to report a history of penicillin allergy, and patients of Asian descent had half the reported prevalence of penicillin allergy, compared with White patients.

Only 6% of the patients reporting penicillin allergy in this study had been referred to an allergy specialist. Given the consequences of true penicillin allergy, this rate is far too low. Patients with a history of penicillin allergy have higher risks for mortality from coexisting hematologic malignancies and penicillin-sensitive infections such as Staphylococcus species. They more frequently develop resistance to multiple antimicrobials and have longer average lengths of stay in the hospital.

Getting a good history for penicillin allergy can be challenging. Approximately three-quarters of penicillin allergies are diagnosed prior to age 3 years. Some children with a family history of penicillin allergy are mislabeled as having an active allergy, even though family history is not a significant contributor to penicillin allergy. Most rashes blamed on penicillin among children are actually not immunoglobulin (Ig) E–mediated and instead represent viral exanthems.

In response to these challenges, at the end of 2022, the American Academy of Allergy, Asthma & Immunology along with the American College of Allergy, Asthma and Immunology published new recommendations for the management of drug allergy. These recommendations provide an algorithm for the active reassessment of penicillin allergy. Like other recommendations in recent years, they call for a proactive approach in questioning the potential clinical consequences of the penicillin allergy listed in the health record.

First, the guidelines recommend against needing any testing for previous adverse reactions to penicillin, such as headache, nausea/vomiting, or diarrhea, that are not IgE-mediated. However, patients who have experienced these adverse reactions may still be reticent to take penicillin. For them and for adults with a history of mild to moderate reactions to penicillin more than 5 years ago, a single oral challenge test with amoxicillin is practical and can be used to exclude penicillin allergy.
 

The oral amoxicillin challenge

After patients take a treatment dose of oral amoxicillin, they should be observed for 1 hour for any objective reaction. The clinical setting should be able to support patients in the rare case of a more severe reaction to penicillin. Subjective symptoms such as pruritus without objective findings such as rash may be considered a successful challenge, and penicillin may be taken off the list of allergies. The treating team can bill CPT codes for drug challenge testing.

Some research has supported multidose testing with amoxicillin to assess for late reactions to a penicillin oral challenge, but the current guidelines recommend against this approach based on the very limited yield in finding additional cases of true allergy with extra doses of antibiotics. One method to address this issue is to have patients advise the practice if symptoms develop within 10 days of the oral challenge, with photos or prompt clinical evaluation to assess for an IgE-mediated reaction.

Many patients, and certainly some clinicians, will have significant trepidation regarding an oral challenge, despite the low risk for complications. For these patients, as well as children with a history of penicillin allergy and patients with a history of anaphylaxis to penicillin or probable IgE-mediated reaction to penicillin in the past several years, skin testing is recommended. Lower-risk patients might feel reassured to complete an oral challenge test after a negative skin test.

Penicillin skin testing is more reliable than a radioallergosorbent test or an enzyme-linked immunoassay and carries a high specificity. However, skin testing requires the specialized care of an allergy clinic, and this resource is limited in many communities.

Many patients will have negative oral challenge or skin testing for penicillin allergy, but there are still some critical responsibilities for the clinician after testing is complete. First, the label of penicillin allergy should be expunged from all available health records. Second, the clinician should communicate clearly and with empathy to the patient that they can take penicillin-based antibiotics safely and with confidence. Repeat testing is unnecessary unless new symptoms develop.

Given the millions of U.S. residents with penicillin allergy documented in the health record but limited resources for allergy testing, we all need to be engaged in proactively delabeling this allergy from patients who can take penicillin antibiotics without problems. But the application of this policy to clinical practice is challenging on several levels, from patient and clinician fear to practical constraints on time.

Dr. Vega is health sciences clinical professor, family medicine, University of California, Irvine. He has disclosed ties with McNeil Pharmaceuticals.

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