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FDA grants emergency authorization for Novavax COVID vaccine
on July 13.
The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.
The Novavax vaccine is only for those who have not yet been vaccinated at all.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.
The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.
A version of this article first appeared on WebMD.com.
on July 13.
The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.
The Novavax vaccine is only for those who have not yet been vaccinated at all.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.
The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.
A version of this article first appeared on WebMD.com.
on July 13.
The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.
The Novavax vaccine is only for those who have not yet been vaccinated at all.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.
The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.
A version of this article first appeared on WebMD.com.
Pembrolizumab for melanoma bittersweet, doctor says
CHICAGO – Pembrolizumab has shown promise as adjuvant therapy for stage IIB and IIC melanoma, shows the first interim analysis of the phase 3 KEYNOTE-716 study recently published in The Lancet.
The findings meet an unmet need as the recurrence risk in stage IIB and IIC melanoma is “underrecognized,” said author Georgina Long, MD, comedical director of the Melanoma Institute Australia, University of Sydney.
In fact, their risk of recurrence is similar to patients with stage IIIB disease, wrote David Killock, PhD, in a related commentary published in Nature Reviews.
The adjuvant treatment resulted in an 89% recurrence-free survival in patients who received pembrolizumab, compared with 83% of patients in the placebo group (hazard ratio, 0.65; P = .0066). These findings were used as the basis for Food and Drug Administration approval of pembrolizumab (Keytruda, Merck) for this patient population in December 2021.
Despite the positive findings, Dr. Killock called for more research on distant metastasis-free survival, overall survival, and quality of life data to “establish the true clinical benefit of adjuvant pembrolizumab.”
At the annual meeting of the American Society of Clinical Oncology, Dr. Long presented the third interim analysis which showed pembrolizumab reduced recurrence and distant metastases at 24 months, although the clinical benefit was relatively small at an approximately 8% improvement in recurrence-free survival and about a 6% improvement in distant metastasis-free survival. About 83% in the pembrolizumab group had treatment-related toxicities versus 64% in the placebo group. There were no deaths caused by treatment. About 90% of pembrolizumab-related endocrinopathies led to long-term hormone replacement.
In a discussion that followed the presentation at ASCO, Charlotte Eielson Ariyan, MD, PhD, said the results are bittersweet. Higher-risk stage IIC patients have a risk of recurrence of about 40%. “It’s high, but the absolute risk reduction is about 8%. This is a very personalized discussion with the patient and the physician in understanding their risk of toxicity is about 17% and higher than their absolute risk reduction with the treatment. For me, this is a bitter pill to swallow because you’re treating people longer and you’re not sure if you’re really helping them. Until we can further define who the highest-risk patients are, I think it’s hard to give it to everyone,” said Dr. Ariyan, who is a surgeon with Memorial Sloan Kettering Cancer Center, New York.
In addition to weighing short-term benefits and toxicity, there are longer-term concerns. Toxicity experienced from PD-1 inhibitors in the adjuvant setting could impact future treatment decisions. “We’re very lucky here in melanoma to know that systemic therapies are effective and we can cure people who recur. I would argue this is why we probably will never really see a difference in the survival benefit in this group because people who cross over will probably do well,” Dr. Ariyan said.
During the Q&A session, Vernon Sondek, MD, Moffitt Cancer Center, Tampa, encouraged physician colleagues to have an open mind about treatments. “Beware of dogma. We thought that adjuvant immunotherapy works much better in patients with ulcerated primary tumors. That’s a dogma in some parts of the world. Yet the T4a patients in KEYNOTE-716 dramatically outperformed the ulcerated T3b and T4b [patients]. We still don’t know what we don’t know.”
The study details
KEYNOTE-716 included 976 patients 12 years or older with newly diagnosed completely resected stage IIB or IIC melanoma with a negative sentinel lymph node. Patients were randomized to placebo or 200 mg pembrolizumab every 3 weeks, or 2 mg/kg in pediatric patients, over 17 cycles. Almost 40% of patients were age 65 or older. T3b and T4b were the most common melanoma subcategories at 41% and 35%, respectively.
The planned third interim analysis occurred after the occurrence of 146 distant metastases. After a median follow-up of 27.4 months, distant metastasis-free survival favored the pembrolizumab group (HR, 0.64; P = .0029). At 24 months, the pembrolizumab group had a higher distant metastasis-free survival at 88.1% versus 82.2% and a lower recurrence rate at 81.2% versus 72.8% (HR, 0.64; 95% confidence interval, 0.50-0.84).
At 24 months, only the T4a patients had a statistically significant reduction in distant metastases at 58% (HR, 0.42; 95% CI, 0.19-0.96), although there were numerical reductions in T3a (HR, 0.71; 95% CI, 0.41-1.22) and T4b (HR, 0.70; 95% CI, 0.44-1.33) patients. Of patients experiencing a distant metastasis, 73% of the placebo group had a first distant metastasis to the lung compared with 49% of the pembrolizumab group.
Dr. Long has held consulting or advisory roles for Merck Sharpe & Dohme, which funded this study.
CHICAGO – Pembrolizumab has shown promise as adjuvant therapy for stage IIB and IIC melanoma, shows the first interim analysis of the phase 3 KEYNOTE-716 study recently published in The Lancet.
The findings meet an unmet need as the recurrence risk in stage IIB and IIC melanoma is “underrecognized,” said author Georgina Long, MD, comedical director of the Melanoma Institute Australia, University of Sydney.
In fact, their risk of recurrence is similar to patients with stage IIIB disease, wrote David Killock, PhD, in a related commentary published in Nature Reviews.
The adjuvant treatment resulted in an 89% recurrence-free survival in patients who received pembrolizumab, compared with 83% of patients in the placebo group (hazard ratio, 0.65; P = .0066). These findings were used as the basis for Food and Drug Administration approval of pembrolizumab (Keytruda, Merck) for this patient population in December 2021.
Despite the positive findings, Dr. Killock called for more research on distant metastasis-free survival, overall survival, and quality of life data to “establish the true clinical benefit of adjuvant pembrolizumab.”
At the annual meeting of the American Society of Clinical Oncology, Dr. Long presented the third interim analysis which showed pembrolizumab reduced recurrence and distant metastases at 24 months, although the clinical benefit was relatively small at an approximately 8% improvement in recurrence-free survival and about a 6% improvement in distant metastasis-free survival. About 83% in the pembrolizumab group had treatment-related toxicities versus 64% in the placebo group. There were no deaths caused by treatment. About 90% of pembrolizumab-related endocrinopathies led to long-term hormone replacement.
In a discussion that followed the presentation at ASCO, Charlotte Eielson Ariyan, MD, PhD, said the results are bittersweet. Higher-risk stage IIC patients have a risk of recurrence of about 40%. “It’s high, but the absolute risk reduction is about 8%. This is a very personalized discussion with the patient and the physician in understanding their risk of toxicity is about 17% and higher than their absolute risk reduction with the treatment. For me, this is a bitter pill to swallow because you’re treating people longer and you’re not sure if you’re really helping them. Until we can further define who the highest-risk patients are, I think it’s hard to give it to everyone,” said Dr. Ariyan, who is a surgeon with Memorial Sloan Kettering Cancer Center, New York.
In addition to weighing short-term benefits and toxicity, there are longer-term concerns. Toxicity experienced from PD-1 inhibitors in the adjuvant setting could impact future treatment decisions. “We’re very lucky here in melanoma to know that systemic therapies are effective and we can cure people who recur. I would argue this is why we probably will never really see a difference in the survival benefit in this group because people who cross over will probably do well,” Dr. Ariyan said.
During the Q&A session, Vernon Sondek, MD, Moffitt Cancer Center, Tampa, encouraged physician colleagues to have an open mind about treatments. “Beware of dogma. We thought that adjuvant immunotherapy works much better in patients with ulcerated primary tumors. That’s a dogma in some parts of the world. Yet the T4a patients in KEYNOTE-716 dramatically outperformed the ulcerated T3b and T4b [patients]. We still don’t know what we don’t know.”
The study details
KEYNOTE-716 included 976 patients 12 years or older with newly diagnosed completely resected stage IIB or IIC melanoma with a negative sentinel lymph node. Patients were randomized to placebo or 200 mg pembrolizumab every 3 weeks, or 2 mg/kg in pediatric patients, over 17 cycles. Almost 40% of patients were age 65 or older. T3b and T4b were the most common melanoma subcategories at 41% and 35%, respectively.
The planned third interim analysis occurred after the occurrence of 146 distant metastases. After a median follow-up of 27.4 months, distant metastasis-free survival favored the pembrolizumab group (HR, 0.64; P = .0029). At 24 months, the pembrolizumab group had a higher distant metastasis-free survival at 88.1% versus 82.2% and a lower recurrence rate at 81.2% versus 72.8% (HR, 0.64; 95% confidence interval, 0.50-0.84).
At 24 months, only the T4a patients had a statistically significant reduction in distant metastases at 58% (HR, 0.42; 95% CI, 0.19-0.96), although there were numerical reductions in T3a (HR, 0.71; 95% CI, 0.41-1.22) and T4b (HR, 0.70; 95% CI, 0.44-1.33) patients. Of patients experiencing a distant metastasis, 73% of the placebo group had a first distant metastasis to the lung compared with 49% of the pembrolizumab group.
Dr. Long has held consulting or advisory roles for Merck Sharpe & Dohme, which funded this study.
CHICAGO – Pembrolizumab has shown promise as adjuvant therapy for stage IIB and IIC melanoma, shows the first interim analysis of the phase 3 KEYNOTE-716 study recently published in The Lancet.
The findings meet an unmet need as the recurrence risk in stage IIB and IIC melanoma is “underrecognized,” said author Georgina Long, MD, comedical director of the Melanoma Institute Australia, University of Sydney.
In fact, their risk of recurrence is similar to patients with stage IIIB disease, wrote David Killock, PhD, in a related commentary published in Nature Reviews.
The adjuvant treatment resulted in an 89% recurrence-free survival in patients who received pembrolizumab, compared with 83% of patients in the placebo group (hazard ratio, 0.65; P = .0066). These findings were used as the basis for Food and Drug Administration approval of pembrolizumab (Keytruda, Merck) for this patient population in December 2021.
Despite the positive findings, Dr. Killock called for more research on distant metastasis-free survival, overall survival, and quality of life data to “establish the true clinical benefit of adjuvant pembrolizumab.”
At the annual meeting of the American Society of Clinical Oncology, Dr. Long presented the third interim analysis which showed pembrolizumab reduced recurrence and distant metastases at 24 months, although the clinical benefit was relatively small at an approximately 8% improvement in recurrence-free survival and about a 6% improvement in distant metastasis-free survival. About 83% in the pembrolizumab group had treatment-related toxicities versus 64% in the placebo group. There were no deaths caused by treatment. About 90% of pembrolizumab-related endocrinopathies led to long-term hormone replacement.
In a discussion that followed the presentation at ASCO, Charlotte Eielson Ariyan, MD, PhD, said the results are bittersweet. Higher-risk stage IIC patients have a risk of recurrence of about 40%. “It’s high, but the absolute risk reduction is about 8%. This is a very personalized discussion with the patient and the physician in understanding their risk of toxicity is about 17% and higher than their absolute risk reduction with the treatment. For me, this is a bitter pill to swallow because you’re treating people longer and you’re not sure if you’re really helping them. Until we can further define who the highest-risk patients are, I think it’s hard to give it to everyone,” said Dr. Ariyan, who is a surgeon with Memorial Sloan Kettering Cancer Center, New York.
In addition to weighing short-term benefits and toxicity, there are longer-term concerns. Toxicity experienced from PD-1 inhibitors in the adjuvant setting could impact future treatment decisions. “We’re very lucky here in melanoma to know that systemic therapies are effective and we can cure people who recur. I would argue this is why we probably will never really see a difference in the survival benefit in this group because people who cross over will probably do well,” Dr. Ariyan said.
During the Q&A session, Vernon Sondek, MD, Moffitt Cancer Center, Tampa, encouraged physician colleagues to have an open mind about treatments. “Beware of dogma. We thought that adjuvant immunotherapy works much better in patients with ulcerated primary tumors. That’s a dogma in some parts of the world. Yet the T4a patients in KEYNOTE-716 dramatically outperformed the ulcerated T3b and T4b [patients]. We still don’t know what we don’t know.”
The study details
KEYNOTE-716 included 976 patients 12 years or older with newly diagnosed completely resected stage IIB or IIC melanoma with a negative sentinel lymph node. Patients were randomized to placebo or 200 mg pembrolizumab every 3 weeks, or 2 mg/kg in pediatric patients, over 17 cycles. Almost 40% of patients were age 65 or older. T3b and T4b were the most common melanoma subcategories at 41% and 35%, respectively.
The planned third interim analysis occurred after the occurrence of 146 distant metastases. After a median follow-up of 27.4 months, distant metastasis-free survival favored the pembrolizumab group (HR, 0.64; P = .0029). At 24 months, the pembrolizumab group had a higher distant metastasis-free survival at 88.1% versus 82.2% and a lower recurrence rate at 81.2% versus 72.8% (HR, 0.64; 95% confidence interval, 0.50-0.84).
At 24 months, only the T4a patients had a statistically significant reduction in distant metastases at 58% (HR, 0.42; 95% CI, 0.19-0.96), although there were numerical reductions in T3a (HR, 0.71; 95% CI, 0.41-1.22) and T4b (HR, 0.70; 95% CI, 0.44-1.33) patients. Of patients experiencing a distant metastasis, 73% of the placebo group had a first distant metastasis to the lung compared with 49% of the pembrolizumab group.
Dr. Long has held consulting or advisory roles for Merck Sharpe & Dohme, which funded this study.
AT ASCO 2022
What influences a trainee’s decision to choose pediatric dermatology as a career?
INDIANAPOLIS – Three during and after fellowship.
Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.
According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.
“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”
For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.
In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).
In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).
“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”
The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.
Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).
In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).
Adelaide A. Hebert, MD, who was asked to comment on the study, said that the lack of salary benefit from additional training is a sticking point for many fellows. “The market trends of supply and demand do not work in pediatric dermatology,” said Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. “You would think that, because there are fewer of us, we should be paid more, but it does not work that way.”
She characterized the overall study findings as “a real testament to what the challenges are” in recruiting trainees to pediatric dermatology. “The influence of mentors resonates in this assessment, but influences that are somewhat beyond our control also play a role, such as lack of salary benefit from additional training, interest in seeing adult patients, and financial factors.”
Neither the researchers nor Dr. Hebert reported having relevant financial disclosures.
INDIANAPOLIS – Three during and after fellowship.
Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.
According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.
“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”
For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.
In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).
In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).
“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”
The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.
Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).
In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).
Adelaide A. Hebert, MD, who was asked to comment on the study, said that the lack of salary benefit from additional training is a sticking point for many fellows. “The market trends of supply and demand do not work in pediatric dermatology,” said Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. “You would think that, because there are fewer of us, we should be paid more, but it does not work that way.”
She characterized the overall study findings as “a real testament to what the challenges are” in recruiting trainees to pediatric dermatology. “The influence of mentors resonates in this assessment, but influences that are somewhat beyond our control also play a role, such as lack of salary benefit from additional training, interest in seeing adult patients, and financial factors.”
Neither the researchers nor Dr. Hebert reported having relevant financial disclosures.
INDIANAPOLIS – Three during and after fellowship.
Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.
According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.
“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”
For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.
In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).
In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).
“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”
The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.
Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).
In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).
Adelaide A. Hebert, MD, who was asked to comment on the study, said that the lack of salary benefit from additional training is a sticking point for many fellows. “The market trends of supply and demand do not work in pediatric dermatology,” said Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. “You would think that, because there are fewer of us, we should be paid more, but it does not work that way.”
She characterized the overall study findings as “a real testament to what the challenges are” in recruiting trainees to pediatric dermatology. “The influence of mentors resonates in this assessment, but influences that are somewhat beyond our control also play a role, such as lack of salary benefit from additional training, interest in seeing adult patients, and financial factors.”
Neither the researchers nor Dr. Hebert reported having relevant financial disclosures.
AT SPD 2022
Physicians urged to write indications on drug scripts as methotrexate users face new barriers with SCOTUS decision
.
The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.
“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”
Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.
Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.
MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
Texas pharmacies target two drugs
MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.
The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.
The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.
In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”
MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.
“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.
“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.
The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.
“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
Conflicting laws pose challenges for physicians
In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.
North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.
APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.
Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
Denials aren’t widespread
Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.
Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.
It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”
Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.
Specificity is key in writing Rx scripts
Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.
Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.
She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.
Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.
Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.
Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
Actions at the federal, state level
President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.
In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”
ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.
The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.
“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.
This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.
Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”
Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”
Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”
Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.
A version of this article first appeared on Medscape.com.
.
The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.
“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”
Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.
Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.
MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
Texas pharmacies target two drugs
MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.
The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.
The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.
In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”
MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.
“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.
“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.
The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.
“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
Conflicting laws pose challenges for physicians
In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.
North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.
APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.
Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
Denials aren’t widespread
Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.
Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.
It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”
Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.
Specificity is key in writing Rx scripts
Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.
Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.
She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.
Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.
Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.
Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
Actions at the federal, state level
President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.
In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”
ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.
The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.
“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.
This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.
Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”
Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”
Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”
Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.
A version of this article first appeared on Medscape.com.
.
The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.
“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”
Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.
Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.
MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
Texas pharmacies target two drugs
MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.
The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.
The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.
In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”
MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.
“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.
“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.
The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.
“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
Conflicting laws pose challenges for physicians
In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.
North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.
APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.
Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
Denials aren’t widespread
Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.
Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.
It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”
Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.
Specificity is key in writing Rx scripts
Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.
Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.
She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.
Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.
Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.
Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
Actions at the federal, state level
President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.
In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”
ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.
The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.
“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.
This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.
Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”
Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”
Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”
Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.
A version of this article first appeared on Medscape.com.
Topical gel for epidermolysis bullosa shows ongoing benefit
GLASGOW, Scotland – the phase 3 safety and efficacy study of the treatment.
Over 200 patients from the trial, including 105 who began treatment with a control gel, continued taking oleogel-S10 after 90 days. The current interim analysis at 12 months indicates there was a 55% reduction in the proportion of the body affected, compared with baseline.
Moreover, reductions in skin activity scores seen in the double-blind phase of the trial were maintained during the open-label extension. About 6% of patients experienced adverse events that led to withdrawal from the study.
The results show that oleogel-S10 was associated with “accelerated wound healing,” said study presenter Tracey Cunningham, MD, chief medical officer, Amryt Pharmaceuticals DAC, Dublin, which is developing the topical agent. “There were no new safety signals with this longer exposure to oleogel-S10, and patients had sustained improvement in wound burden,” she added.
The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 6.
In April, European Medicines Agency recommended approval of oleogel-S10 for the treatment of partial-thickness skin wounds associated with dystrophic and junctional EB for patients aged 6 months and older.
However, just a month earlier, the U.S. Food and Drug Administration declined to approve the topical agent for use in EB, even after it extended its review by 3 months to include additional analyses of data previously submitted by the company.
In the post-presentation discussion, Dr. Cunningham said that the FDA had “not been satisfied at this point with the information that we have given them,” adding, “We don’t agree with the decision, and we will be appealing.”
Raman K. Madan, MD, a dermatologist at Northwell Health, Huntington, New York, who was not involved in the study, said that the reductions in wound healing seen in the study are “meaningful” and that the numbers represent a “big breakthrough.”
He told this news organization that there are “very few products on the market” for EB and that having an option for patients “would be amazing.”
“The big issue here would be cost and coverage for patients,” he said. If approved, “hopefully” it will be affordable, he added.
Dr. Madan noted that from his perspective, the majority of the reactions to the topical gel were “mild,” and there are “a lot of confounding factors” underlying the number of serious adverse events. “These patients with epidermolysis are prone to some of these issues regardless of treatment,” he said.
During her presentation, Dr. Cunningham noted that EB is a rare, debilitating condition that is characterized by varying degrees of skin fragility, blisters, and impaired wound healing that in turn lead to serious complications that affect quality of life.
While wound management is a “fundamental priority” for patients living with EB, she said, there is a “high, unmet” clinical need.
To those ends, EASE was the largest randomized controlled phase 3 efficacy and safety study in EB. In the study, 252 patients were allocated to receive oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing.
The double-blind phase of the trial met its primary endpoint: A higher proportion of patients who were given oleogel-S10 achieved first complete closure of the EB target wound by day 45, compared with patients who were given control gel, at 41.3% versus 28.9%. This equated to a relative risk of wound closure by day 45 of 1.44, or an odds ratio of 1.84 (P = .013).
However, as reported at the time by this news organization, the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of oleogel-S10 patients achieving wound closure, versus 43.9% of those in the control group.
Dr. Cunningham discussed the open-label extension, which involved 205 patients from the double-blind phase (mean age, of 16.3 years) treated with oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing for 24 months.
In presenting the results of the first 12 months of the open-label extension, she said that oleogel-S10 led to “consistent” reductions in the body surface area percentage (BSAP) affected by EB. The overall reduction from baseline was 55% after receiving treatment for 15 months.
Between day 90 and month 12 of the open-label extension, the absolute BSAP was reduced from 7.4% to 5.4% for patients who had received oleogel-S10 from the start of the study. For those who started in the control group and then switched to the oleogel-S10 arm during the open-label extension, the reduction was from 8.3% to 6.4%.
Dr. Cunningham pointed out that a 1% reduction in BSAP equates approximately to the palmar surface of the hand.
Scores on the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Skin activity subscale indicated that the reductions achieved in the double-blind phase of the trial were maintained.
Among patients who received oleogel-S10 from the start of the trial, EBDASI Skin scores were reduced from 19.6 at baseline to 13.5 at 12 months’ follow-up in the open-label extension. The reduction was from 19.6 to 13.5 for those who began the trial taking control gel.
Dr. Cunningham showed that adverse events of any grade were seen in 72.0% of patients who began taking oleogel-S10 at the start of the trial and in 69.5% of those who began the trial taking control gel.
Serious adverse events were recorded in 23.0% and 20.0% of patients, respectively, while 6.0% of those who initially received oleogel-S10 and 6.7% of those initially assigned to control gel experienced adverse events that led to study withdrawal during the open-label phase.
The most frequently reported adverse events in the open-label extension were wound complications, seen in 39.5% of patients; anemia, seen in 14.1%; wound infection, seen in 9.3%; pyrexia, seen in 8.3%; and pruritus, seen in 5.9%. No more details regarding adverse events were provided.
The study was funded by Amryt Pharmaceuticals DAC. Dr. Cunningham is an employee of Amryt Pharmaceuticals. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
GLASGOW, Scotland – the phase 3 safety and efficacy study of the treatment.
Over 200 patients from the trial, including 105 who began treatment with a control gel, continued taking oleogel-S10 after 90 days. The current interim analysis at 12 months indicates there was a 55% reduction in the proportion of the body affected, compared with baseline.
Moreover, reductions in skin activity scores seen in the double-blind phase of the trial were maintained during the open-label extension. About 6% of patients experienced adverse events that led to withdrawal from the study.
The results show that oleogel-S10 was associated with “accelerated wound healing,” said study presenter Tracey Cunningham, MD, chief medical officer, Amryt Pharmaceuticals DAC, Dublin, which is developing the topical agent. “There were no new safety signals with this longer exposure to oleogel-S10, and patients had sustained improvement in wound burden,” she added.
The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 6.
In April, European Medicines Agency recommended approval of oleogel-S10 for the treatment of partial-thickness skin wounds associated with dystrophic and junctional EB for patients aged 6 months and older.
However, just a month earlier, the U.S. Food and Drug Administration declined to approve the topical agent for use in EB, even after it extended its review by 3 months to include additional analyses of data previously submitted by the company.
In the post-presentation discussion, Dr. Cunningham said that the FDA had “not been satisfied at this point with the information that we have given them,” adding, “We don’t agree with the decision, and we will be appealing.”
Raman K. Madan, MD, a dermatologist at Northwell Health, Huntington, New York, who was not involved in the study, said that the reductions in wound healing seen in the study are “meaningful” and that the numbers represent a “big breakthrough.”
He told this news organization that there are “very few products on the market” for EB and that having an option for patients “would be amazing.”
“The big issue here would be cost and coverage for patients,” he said. If approved, “hopefully” it will be affordable, he added.
Dr. Madan noted that from his perspective, the majority of the reactions to the topical gel were “mild,” and there are “a lot of confounding factors” underlying the number of serious adverse events. “These patients with epidermolysis are prone to some of these issues regardless of treatment,” he said.
During her presentation, Dr. Cunningham noted that EB is a rare, debilitating condition that is characterized by varying degrees of skin fragility, blisters, and impaired wound healing that in turn lead to serious complications that affect quality of life.
While wound management is a “fundamental priority” for patients living with EB, she said, there is a “high, unmet” clinical need.
To those ends, EASE was the largest randomized controlled phase 3 efficacy and safety study in EB. In the study, 252 patients were allocated to receive oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing.
The double-blind phase of the trial met its primary endpoint: A higher proportion of patients who were given oleogel-S10 achieved first complete closure of the EB target wound by day 45, compared with patients who were given control gel, at 41.3% versus 28.9%. This equated to a relative risk of wound closure by day 45 of 1.44, or an odds ratio of 1.84 (P = .013).
However, as reported at the time by this news organization, the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of oleogel-S10 patients achieving wound closure, versus 43.9% of those in the control group.
Dr. Cunningham discussed the open-label extension, which involved 205 patients from the double-blind phase (mean age, of 16.3 years) treated with oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing for 24 months.
In presenting the results of the first 12 months of the open-label extension, she said that oleogel-S10 led to “consistent” reductions in the body surface area percentage (BSAP) affected by EB. The overall reduction from baseline was 55% after receiving treatment for 15 months.
Between day 90 and month 12 of the open-label extension, the absolute BSAP was reduced from 7.4% to 5.4% for patients who had received oleogel-S10 from the start of the study. For those who started in the control group and then switched to the oleogel-S10 arm during the open-label extension, the reduction was from 8.3% to 6.4%.
Dr. Cunningham pointed out that a 1% reduction in BSAP equates approximately to the palmar surface of the hand.
Scores on the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Skin activity subscale indicated that the reductions achieved in the double-blind phase of the trial were maintained.
Among patients who received oleogel-S10 from the start of the trial, EBDASI Skin scores were reduced from 19.6 at baseline to 13.5 at 12 months’ follow-up in the open-label extension. The reduction was from 19.6 to 13.5 for those who began the trial taking control gel.
Dr. Cunningham showed that adverse events of any grade were seen in 72.0% of patients who began taking oleogel-S10 at the start of the trial and in 69.5% of those who began the trial taking control gel.
Serious adverse events were recorded in 23.0% and 20.0% of patients, respectively, while 6.0% of those who initially received oleogel-S10 and 6.7% of those initially assigned to control gel experienced adverse events that led to study withdrawal during the open-label phase.
The most frequently reported adverse events in the open-label extension were wound complications, seen in 39.5% of patients; anemia, seen in 14.1%; wound infection, seen in 9.3%; pyrexia, seen in 8.3%; and pruritus, seen in 5.9%. No more details regarding adverse events were provided.
The study was funded by Amryt Pharmaceuticals DAC. Dr. Cunningham is an employee of Amryt Pharmaceuticals. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
GLASGOW, Scotland – the phase 3 safety and efficacy study of the treatment.
Over 200 patients from the trial, including 105 who began treatment with a control gel, continued taking oleogel-S10 after 90 days. The current interim analysis at 12 months indicates there was a 55% reduction in the proportion of the body affected, compared with baseline.
Moreover, reductions in skin activity scores seen in the double-blind phase of the trial were maintained during the open-label extension. About 6% of patients experienced adverse events that led to withdrawal from the study.
The results show that oleogel-S10 was associated with “accelerated wound healing,” said study presenter Tracey Cunningham, MD, chief medical officer, Amryt Pharmaceuticals DAC, Dublin, which is developing the topical agent. “There were no new safety signals with this longer exposure to oleogel-S10, and patients had sustained improvement in wound burden,” she added.
The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 6.
In April, European Medicines Agency recommended approval of oleogel-S10 for the treatment of partial-thickness skin wounds associated with dystrophic and junctional EB for patients aged 6 months and older.
However, just a month earlier, the U.S. Food and Drug Administration declined to approve the topical agent for use in EB, even after it extended its review by 3 months to include additional analyses of data previously submitted by the company.
In the post-presentation discussion, Dr. Cunningham said that the FDA had “not been satisfied at this point with the information that we have given them,” adding, “We don’t agree with the decision, and we will be appealing.”
Raman K. Madan, MD, a dermatologist at Northwell Health, Huntington, New York, who was not involved in the study, said that the reductions in wound healing seen in the study are “meaningful” and that the numbers represent a “big breakthrough.”
He told this news organization that there are “very few products on the market” for EB and that having an option for patients “would be amazing.”
“The big issue here would be cost and coverage for patients,” he said. If approved, “hopefully” it will be affordable, he added.
Dr. Madan noted that from his perspective, the majority of the reactions to the topical gel were “mild,” and there are “a lot of confounding factors” underlying the number of serious adverse events. “These patients with epidermolysis are prone to some of these issues regardless of treatment,” he said.
During her presentation, Dr. Cunningham noted that EB is a rare, debilitating condition that is characterized by varying degrees of skin fragility, blisters, and impaired wound healing that in turn lead to serious complications that affect quality of life.
While wound management is a “fundamental priority” for patients living with EB, she said, there is a “high, unmet” clinical need.
To those ends, EASE was the largest randomized controlled phase 3 efficacy and safety study in EB. In the study, 252 patients were allocated to receive oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing.
The double-blind phase of the trial met its primary endpoint: A higher proportion of patients who were given oleogel-S10 achieved first complete closure of the EB target wound by day 45, compared with patients who were given control gel, at 41.3% versus 28.9%. This equated to a relative risk of wound closure by day 45 of 1.44, or an odds ratio of 1.84 (P = .013).
However, as reported at the time by this news organization, the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of oleogel-S10 patients achieving wound closure, versus 43.9% of those in the control group.
Dr. Cunningham discussed the open-label extension, which involved 205 patients from the double-blind phase (mean age, of 16.3 years) treated with oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing for 24 months.
In presenting the results of the first 12 months of the open-label extension, she said that oleogel-S10 led to “consistent” reductions in the body surface area percentage (BSAP) affected by EB. The overall reduction from baseline was 55% after receiving treatment for 15 months.
Between day 90 and month 12 of the open-label extension, the absolute BSAP was reduced from 7.4% to 5.4% for patients who had received oleogel-S10 from the start of the study. For those who started in the control group and then switched to the oleogel-S10 arm during the open-label extension, the reduction was from 8.3% to 6.4%.
Dr. Cunningham pointed out that a 1% reduction in BSAP equates approximately to the palmar surface of the hand.
Scores on the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Skin activity subscale indicated that the reductions achieved in the double-blind phase of the trial were maintained.
Among patients who received oleogel-S10 from the start of the trial, EBDASI Skin scores were reduced from 19.6 at baseline to 13.5 at 12 months’ follow-up in the open-label extension. The reduction was from 19.6 to 13.5 for those who began the trial taking control gel.
Dr. Cunningham showed that adverse events of any grade were seen in 72.0% of patients who began taking oleogel-S10 at the start of the trial and in 69.5% of those who began the trial taking control gel.
Serious adverse events were recorded in 23.0% and 20.0% of patients, respectively, while 6.0% of those who initially received oleogel-S10 and 6.7% of those initially assigned to control gel experienced adverse events that led to study withdrawal during the open-label phase.
The most frequently reported adverse events in the open-label extension were wound complications, seen in 39.5% of patients; anemia, seen in 14.1%; wound infection, seen in 9.3%; pyrexia, seen in 8.3%; and pruritus, seen in 5.9%. No more details regarding adverse events were provided.
The study was funded by Amryt Pharmaceuticals DAC. Dr. Cunningham is an employee of Amryt Pharmaceuticals. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
Inflation and health care: The prognosis for doctors
Rampant inflation doesn’t just mean a spike in everyday expenses like gas and groceries. It’s also bound to have a significant impact on the cost of health care – and on your practice. A recent report from McKinsey & Company predicts that the current inflationary spiral will force health care providers to charge higher reimbursement rates, and those costs inevitably will be passed along to both employers and consumers. Bottom line: Your patients will likely have to pay more out of pocket.
How, precisely, will inflation affect your practice, and what’s the best way to minimize the damage?
Step 1: Maintain operational standards
“Based on the conversations we’ve had with our physician clients that own practices, we see the potential for cost inflation to outrun revenue inflation over the next year,” said Michael Ashley Schulman, CFA, partner and chief investment officer at Running Point Capital, El Segundo, Calif. “Staff wages, as well as office equipment and medical supply costs, are increasing faster than insurance and Medicare/Medicaid reimbursement amounts.” Even so, topflight employees are essential to keep your practice running smoothly. Prioritize excellent nursing. Instead of adding a new hire, compensate your best nurse as well as possible. The same goes for an efficient office manager: On that front, too, you should go the extra mile, even if it means trimming expenses elsewhere.
Step 2: Plan ahead for insurance challenges
Many insurers, including Medicare, set health care costs a year in advance, based on projected growth. This means insurance payouts will stay largely the same for the time being. “Almost all physicians employed by large groups won’t see costs due to inflation rise until next year,” said Mark V. Pauly, PhD, Bendheim Professor in the department of health care management at the University of Pennsylvania, Philadelphia. “For self-employed physicians, there will also be a cushion.”
“The big issue with inflation is that more patients will likely be underinsured,” said Tiffany Johnson, MBA, CFP, co-CEO and financial advisor at Piece of Wealth Planning in Atlanta. “With more out-of-pocket costs ... these patients may not seek out medical treatment or go to see a specialist if they do not believe it is necessary.” A new study from Johns Hopkins found that patients under financial pressure often delay or forgo medical treatment because of food insecurity. Compassionate care is the solution: Direct these patients to financial aid and other resources they may qualify for. That way, they can continue to receive the care they need from you, and your need to pass on costs may be lower.
Step 3: Rely on your affiliated health care organization
These are tough times when it comes to expansion. “Since we are in an environment where inflation and interest rates are both high, it will be much harder for physicians to have the capital to invest in new technology to grow or advance their practice,” Ms. Johnson said. With that in mind, keep the lines of communication between you and your affiliated hospital/health care organization more open than ever. Combining practices with another doctor is one way to increase revenue; you might ask if any affiliated doctors are seeking to team up. It’s also vital to attend meetings and pay close attention to budget cuts your organization may be making. And don’t be shy about asking your administrator for profit-boosting recommendations.
Step 4: Revisit vendor relationships
Find out if your vendors will continue to supply you with the goods you need at reasonable rates, and switch now if they won’t. Be proactive. “Test new medical suppliers,” Mr. Schulman advised. “Reread equipment leasing contracts to check if the interest rates have increased. See if buyout, prepay, or refinancing options are more economical. Also, investigate [bringing down] your rental expense by reducing square footage or moving to a lower-cost location.” In light of ongoing supply chain issues, it’s wise to consider alternative products. But stay focused on quality – you don’t want to be stuck with cheap, possibly defective equipment. Spend where it’s essential and cut the fat somewhere else.
Step 5: Don’t waste your assets
Analyze your budget in minute detail. “Now is the time to review your current inventory and overhead costs,” Ms. Johnson said. “Many physicians let their office staff handle the restocking of inventory and office supplies. While this can be efficient for their practice, it also leaves room for unnecessary business expenses.” Take a cold, hard look at your supply closet – what’s in there that you can live without? Don’t reorder it. Then seek out any revenue stream you may be overlooking. “It’s important to review billing to make sure all the services are reimbursable,” Ms. Johnson added. Small mistakes can yield dividends if you find them.
Step 6: Be poised to pivot
Get creative. “To minimize a profit decline, use video consulting – it’s more efficient and less equipment intensive,” Mr. Schulman said. “Look at how remote work and flexible hours can maximize the work your practice accomplishes while cutting office costs.”
Ms. Johnson suggests adding concierge services, noting that “concierge doctors offer personalized care and direct access for an up-front fee.” With this approach, you may see fewer patients, but your payout paperwork will decrease, and that up-front fee can be profitable. Another outside-the-box idea: Start making house calls. A Scripps study found that home health visits requested via app can result in patient care delivered by a doctor and medical assistant in less than 2 hours. House calls can be an effective and profitable solution when it comes to providing nonemergency care and preventive treatment to patients who aren’t mobile, not to mention patients who just appreciate the convenience.
Step 7: Maintain transparency
Any economic changes your practice will implement must be communicated to your staff and patients clearly and directly. Keep everyone in the loop and be ready to answer questions immediately. Show those you work with and care for that, regardless of the economy, it’s they who matter to you most. That simple reassurance will prove invaluable.
A version of this article first appeared on Medscape.com.
Rampant inflation doesn’t just mean a spike in everyday expenses like gas and groceries. It’s also bound to have a significant impact on the cost of health care – and on your practice. A recent report from McKinsey & Company predicts that the current inflationary spiral will force health care providers to charge higher reimbursement rates, and those costs inevitably will be passed along to both employers and consumers. Bottom line: Your patients will likely have to pay more out of pocket.
How, precisely, will inflation affect your practice, and what’s the best way to minimize the damage?
Step 1: Maintain operational standards
“Based on the conversations we’ve had with our physician clients that own practices, we see the potential for cost inflation to outrun revenue inflation over the next year,” said Michael Ashley Schulman, CFA, partner and chief investment officer at Running Point Capital, El Segundo, Calif. “Staff wages, as well as office equipment and medical supply costs, are increasing faster than insurance and Medicare/Medicaid reimbursement amounts.” Even so, topflight employees are essential to keep your practice running smoothly. Prioritize excellent nursing. Instead of adding a new hire, compensate your best nurse as well as possible. The same goes for an efficient office manager: On that front, too, you should go the extra mile, even if it means trimming expenses elsewhere.
Step 2: Plan ahead for insurance challenges
Many insurers, including Medicare, set health care costs a year in advance, based on projected growth. This means insurance payouts will stay largely the same for the time being. “Almost all physicians employed by large groups won’t see costs due to inflation rise until next year,” said Mark V. Pauly, PhD, Bendheim Professor in the department of health care management at the University of Pennsylvania, Philadelphia. “For self-employed physicians, there will also be a cushion.”
“The big issue with inflation is that more patients will likely be underinsured,” said Tiffany Johnson, MBA, CFP, co-CEO and financial advisor at Piece of Wealth Planning in Atlanta. “With more out-of-pocket costs ... these patients may not seek out medical treatment or go to see a specialist if they do not believe it is necessary.” A new study from Johns Hopkins found that patients under financial pressure often delay or forgo medical treatment because of food insecurity. Compassionate care is the solution: Direct these patients to financial aid and other resources they may qualify for. That way, they can continue to receive the care they need from you, and your need to pass on costs may be lower.
Step 3: Rely on your affiliated health care organization
These are tough times when it comes to expansion. “Since we are in an environment where inflation and interest rates are both high, it will be much harder for physicians to have the capital to invest in new technology to grow or advance their practice,” Ms. Johnson said. With that in mind, keep the lines of communication between you and your affiliated hospital/health care organization more open than ever. Combining practices with another doctor is one way to increase revenue; you might ask if any affiliated doctors are seeking to team up. It’s also vital to attend meetings and pay close attention to budget cuts your organization may be making. And don’t be shy about asking your administrator for profit-boosting recommendations.
Step 4: Revisit vendor relationships
Find out if your vendors will continue to supply you with the goods you need at reasonable rates, and switch now if they won’t. Be proactive. “Test new medical suppliers,” Mr. Schulman advised. “Reread equipment leasing contracts to check if the interest rates have increased. See if buyout, prepay, or refinancing options are more economical. Also, investigate [bringing down] your rental expense by reducing square footage or moving to a lower-cost location.” In light of ongoing supply chain issues, it’s wise to consider alternative products. But stay focused on quality – you don’t want to be stuck with cheap, possibly defective equipment. Spend where it’s essential and cut the fat somewhere else.
Step 5: Don’t waste your assets
Analyze your budget in minute detail. “Now is the time to review your current inventory and overhead costs,” Ms. Johnson said. “Many physicians let their office staff handle the restocking of inventory and office supplies. While this can be efficient for their practice, it also leaves room for unnecessary business expenses.” Take a cold, hard look at your supply closet – what’s in there that you can live without? Don’t reorder it. Then seek out any revenue stream you may be overlooking. “It’s important to review billing to make sure all the services are reimbursable,” Ms. Johnson added. Small mistakes can yield dividends if you find them.
Step 6: Be poised to pivot
Get creative. “To minimize a profit decline, use video consulting – it’s more efficient and less equipment intensive,” Mr. Schulman said. “Look at how remote work and flexible hours can maximize the work your practice accomplishes while cutting office costs.”
Ms. Johnson suggests adding concierge services, noting that “concierge doctors offer personalized care and direct access for an up-front fee.” With this approach, you may see fewer patients, but your payout paperwork will decrease, and that up-front fee can be profitable. Another outside-the-box idea: Start making house calls. A Scripps study found that home health visits requested via app can result in patient care delivered by a doctor and medical assistant in less than 2 hours. House calls can be an effective and profitable solution when it comes to providing nonemergency care and preventive treatment to patients who aren’t mobile, not to mention patients who just appreciate the convenience.
Step 7: Maintain transparency
Any economic changes your practice will implement must be communicated to your staff and patients clearly and directly. Keep everyone in the loop and be ready to answer questions immediately. Show those you work with and care for that, regardless of the economy, it’s they who matter to you most. That simple reassurance will prove invaluable.
A version of this article first appeared on Medscape.com.
Rampant inflation doesn’t just mean a spike in everyday expenses like gas and groceries. It’s also bound to have a significant impact on the cost of health care – and on your practice. A recent report from McKinsey & Company predicts that the current inflationary spiral will force health care providers to charge higher reimbursement rates, and those costs inevitably will be passed along to both employers and consumers. Bottom line: Your patients will likely have to pay more out of pocket.
How, precisely, will inflation affect your practice, and what’s the best way to minimize the damage?
Step 1: Maintain operational standards
“Based on the conversations we’ve had with our physician clients that own practices, we see the potential for cost inflation to outrun revenue inflation over the next year,” said Michael Ashley Schulman, CFA, partner and chief investment officer at Running Point Capital, El Segundo, Calif. “Staff wages, as well as office equipment and medical supply costs, are increasing faster than insurance and Medicare/Medicaid reimbursement amounts.” Even so, topflight employees are essential to keep your practice running smoothly. Prioritize excellent nursing. Instead of adding a new hire, compensate your best nurse as well as possible. The same goes for an efficient office manager: On that front, too, you should go the extra mile, even if it means trimming expenses elsewhere.
Step 2: Plan ahead for insurance challenges
Many insurers, including Medicare, set health care costs a year in advance, based on projected growth. This means insurance payouts will stay largely the same for the time being. “Almost all physicians employed by large groups won’t see costs due to inflation rise until next year,” said Mark V. Pauly, PhD, Bendheim Professor in the department of health care management at the University of Pennsylvania, Philadelphia. “For self-employed physicians, there will also be a cushion.”
“The big issue with inflation is that more patients will likely be underinsured,” said Tiffany Johnson, MBA, CFP, co-CEO and financial advisor at Piece of Wealth Planning in Atlanta. “With more out-of-pocket costs ... these patients may not seek out medical treatment or go to see a specialist if they do not believe it is necessary.” A new study from Johns Hopkins found that patients under financial pressure often delay or forgo medical treatment because of food insecurity. Compassionate care is the solution: Direct these patients to financial aid and other resources they may qualify for. That way, they can continue to receive the care they need from you, and your need to pass on costs may be lower.
Step 3: Rely on your affiliated health care organization
These are tough times when it comes to expansion. “Since we are in an environment where inflation and interest rates are both high, it will be much harder for physicians to have the capital to invest in new technology to grow or advance their practice,” Ms. Johnson said. With that in mind, keep the lines of communication between you and your affiliated hospital/health care organization more open than ever. Combining practices with another doctor is one way to increase revenue; you might ask if any affiliated doctors are seeking to team up. It’s also vital to attend meetings and pay close attention to budget cuts your organization may be making. And don’t be shy about asking your administrator for profit-boosting recommendations.
Step 4: Revisit vendor relationships
Find out if your vendors will continue to supply you with the goods you need at reasonable rates, and switch now if they won’t. Be proactive. “Test new medical suppliers,” Mr. Schulman advised. “Reread equipment leasing contracts to check if the interest rates have increased. See if buyout, prepay, or refinancing options are more economical. Also, investigate [bringing down] your rental expense by reducing square footage or moving to a lower-cost location.” In light of ongoing supply chain issues, it’s wise to consider alternative products. But stay focused on quality – you don’t want to be stuck with cheap, possibly defective equipment. Spend where it’s essential and cut the fat somewhere else.
Step 5: Don’t waste your assets
Analyze your budget in minute detail. “Now is the time to review your current inventory and overhead costs,” Ms. Johnson said. “Many physicians let their office staff handle the restocking of inventory and office supplies. While this can be efficient for their practice, it also leaves room for unnecessary business expenses.” Take a cold, hard look at your supply closet – what’s in there that you can live without? Don’t reorder it. Then seek out any revenue stream you may be overlooking. “It’s important to review billing to make sure all the services are reimbursable,” Ms. Johnson added. Small mistakes can yield dividends if you find them.
Step 6: Be poised to pivot
Get creative. “To minimize a profit decline, use video consulting – it’s more efficient and less equipment intensive,” Mr. Schulman said. “Look at how remote work and flexible hours can maximize the work your practice accomplishes while cutting office costs.”
Ms. Johnson suggests adding concierge services, noting that “concierge doctors offer personalized care and direct access for an up-front fee.” With this approach, you may see fewer patients, but your payout paperwork will decrease, and that up-front fee can be profitable. Another outside-the-box idea: Start making house calls. A Scripps study found that home health visits requested via app can result in patient care delivered by a doctor and medical assistant in less than 2 hours. House calls can be an effective and profitable solution when it comes to providing nonemergency care and preventive treatment to patients who aren’t mobile, not to mention patients who just appreciate the convenience.
Step 7: Maintain transparency
Any economic changes your practice will implement must be communicated to your staff and patients clearly and directly. Keep everyone in the loop and be ready to answer questions immediately. Show those you work with and care for that, regardless of the economy, it’s they who matter to you most. That simple reassurance will prove invaluable.
A version of this article first appeared on Medscape.com.
Eczema causes substantial burden for many infants and preschoolers
INDIANAPOLIS – . Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.
For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.
AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.
The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.
More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.
In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.
Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”
The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.
INDIANAPOLIS – . Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.
For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.
AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.
The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.
More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.
In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.
Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”
The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.
INDIANAPOLIS – . Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.
For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.
AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.
The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.
More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.
In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.
Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”
The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.
AT SPD 2022
European survey finds wide variations in the use of phototherapy for atopic eczema
GLASGOW, Scotland – , which points to the need for management guidelines.
Over 140 phototherapy practitioners from 27 European countries responded to the survey. Of the practitioners surveyed, 96% used narrow-band ultraviolet B (NB-UVB), and about 50% prescribed psoralen and ultraviolet A (PUVA) for adults. Fewer than 10% did so for children.
There was considerable variation in prescribing practices, “especially when it comes to dosing and treatment duration,” said study presenter Mia Steyn, MD, dermatology registrar, St. John’s Institute of Dermatology, Guy’s and St. Thomas’s Hospital, London.
These results, she said, demonstrate that “an optimal treatment modality either is not known or agreed upon” and that studies are required to determine treatment efficacy, cost, and safety “in a range of skin types.”
Dr. Steyn said that what is needed first is a set of consensus treatment guidelines, “hopefully leading to a randomized controlled trial” that would compare the various treatment options.
The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 7.
Session co-chair Adam Fityan, MD, a consultant dermatologist at University Hospital Southampton NHS Foundation Trust, U.K., commented that the study was “fascinating” and “really helpful.”
Dr. Fityan, who was not involved with the survey, told this news organization that, “clearly, what we’ve seen is that there is a huge variation in the way everyone uses the different modalities of phototherapy.”
“Having that sort of knowledge will hopefully help us to think a bit more clearly about the regimens and protocols that we use and to maybe find the evidence that everyone needs to have the most effective protocol.”
The data from the study are also useful on an individual level, Dr. Fityan continued, as “you have no idea what anyone is doing” and whether “you are an outlier.”
Dr. Steyn said that phototherapy is commonly used for the treatment of atopic eczema, but the evidence for its efficacy, its impact on quality on life, its cost-effectiveness, and short- and long-term safety is “weak,” particularly in relation to real-life use.
Electronic survey
In lieu of a well-designed randomized controlled trial to answer these questions, the researchers set up a task force to assess how phototherapy is currently being used to treat atopic eczema across the United Kingdom and Europe so as to guide further research.
An electronic survey was devised, and 144 members of phototherapy groups from 27 European countries submitted their responses during 2020. Most responses came from the Netherlands (20), Italy (16), the United Kingdom (14), France (11), and Germany (10).
The results showed that NB-UVB was the most widely used modality of phototherapy, chosen by 96% of respondents. In addition, 17% of respondents said they also prescribed home-based NB-UVB, which was available in eight of the 27 countries.
When asked how they used NB-UVB, the majority (68%) of respondents said they had an age cutoff for use in children, which was set at an average age of 9 years and older, although the range was age 2 years to 16 years.
NBUVB was used as a second-line therapy instead of systemic treatments in up to 93% of adults and in 69% of children. It was used concomitantly with systemic treatment in up to 58% of adults and 11% of children, according to the survey responses.
For about 70% of respondents, the use of NB-UVB was determined by assessing the Fitzpatrick skin type, although almost 40% relied on clinical experience.
Frequency of treatment
NB-UVB was prescribed three times a week by 59% of respondents; 31% of respondents prescribed it twice a week; 7%, five times per week; and 2%, four times a week. The typical number of treatments was 21-30 for 53% of respondents, 0-20 treatments for 24%, and 31-40 treatments for 20%.
The dose was typically increased in 10% increments, although there were wide variations in how the treatment was stepped up. Dose was increased after each treatment by almost 50% of respondents, after every two treatments by almost 25%, and after every three treatments by approximately 15%.
For the majority (53%) of respondents, response to NBUVB was assessed after 7-15 treatments, while 43% waited until after 16-30 treatments. Success was defined as a 75% reduction in eczema from baseline by 56% of respondents, while 54% looked to patient satisfaction, and 47% relied on quality of life to determine success of treatment.
Maintenance NB-UVB was never used by 54% of respondents, but 44% said they used it occasionally, and 83% said they did not follow a weaning schedule at the end of treatment.
The most commonly reported adverse effects of NB-UVB were significant erythema, hyperpigmentation, and eczema flare, while the most commonly cited absolute contraindications included a history of melanoma, a history of squamous cell carcinoma, the use of photosensitizing medications, and claustrophobia.
Use of PUVA, UVA1
The next most commonly used phototherapy for atopic eczema was PUVA. Although it was available to 83% of respondents, only 52% of respondents had personally prescribed the treatment for adults, and only 7% prescribed it for children.
Of the respondents, 71% said they would switch from NB-UVB to PUVA if desired treatment outcomes were not achieved with the former, and 44% said they would “sometimes consider” PUVA as second-line therapy instead of systemic treatments. Only 13% said they would use it concomitantly with systemic treatment.
Ultraviolet A1 (UVA1) phototherapy was not widely available, with 66% of respondents declaring that they did not have access to this option and just 29% saying they prescribed it.
But when it was used, UVA1 was cited as being used often in adults by 24% of respondents, while 33% used it was used sometimes, and 43% said it was used rarely. It was used for children by 26% of respondents. In addition, 29% said they favored using UVA1 for chronic atopic eczema, and 33% favored using it for acute eczema while 38% had no preference over whether to use it for chronic versus acute atopic eczema.
Similarly to NB-UVB, there were wide variations in the use of PUVA and UVA1 by respondents in terms of dosing schedules, duration of treatment, and how response to treatment was measured.
No funding for the study has been reported. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
GLASGOW, Scotland – , which points to the need for management guidelines.
Over 140 phototherapy practitioners from 27 European countries responded to the survey. Of the practitioners surveyed, 96% used narrow-band ultraviolet B (NB-UVB), and about 50% prescribed psoralen and ultraviolet A (PUVA) for adults. Fewer than 10% did so for children.
There was considerable variation in prescribing practices, “especially when it comes to dosing and treatment duration,” said study presenter Mia Steyn, MD, dermatology registrar, St. John’s Institute of Dermatology, Guy’s and St. Thomas’s Hospital, London.
These results, she said, demonstrate that “an optimal treatment modality either is not known or agreed upon” and that studies are required to determine treatment efficacy, cost, and safety “in a range of skin types.”
Dr. Steyn said that what is needed first is a set of consensus treatment guidelines, “hopefully leading to a randomized controlled trial” that would compare the various treatment options.
The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 7.
Session co-chair Adam Fityan, MD, a consultant dermatologist at University Hospital Southampton NHS Foundation Trust, U.K., commented that the study was “fascinating” and “really helpful.”
Dr. Fityan, who was not involved with the survey, told this news organization that, “clearly, what we’ve seen is that there is a huge variation in the way everyone uses the different modalities of phototherapy.”
“Having that sort of knowledge will hopefully help us to think a bit more clearly about the regimens and protocols that we use and to maybe find the evidence that everyone needs to have the most effective protocol.”
The data from the study are also useful on an individual level, Dr. Fityan continued, as “you have no idea what anyone is doing” and whether “you are an outlier.”
Dr. Steyn said that phototherapy is commonly used for the treatment of atopic eczema, but the evidence for its efficacy, its impact on quality on life, its cost-effectiveness, and short- and long-term safety is “weak,” particularly in relation to real-life use.
Electronic survey
In lieu of a well-designed randomized controlled trial to answer these questions, the researchers set up a task force to assess how phototherapy is currently being used to treat atopic eczema across the United Kingdom and Europe so as to guide further research.
An electronic survey was devised, and 144 members of phototherapy groups from 27 European countries submitted their responses during 2020. Most responses came from the Netherlands (20), Italy (16), the United Kingdom (14), France (11), and Germany (10).
The results showed that NB-UVB was the most widely used modality of phototherapy, chosen by 96% of respondents. In addition, 17% of respondents said they also prescribed home-based NB-UVB, which was available in eight of the 27 countries.
When asked how they used NB-UVB, the majority (68%) of respondents said they had an age cutoff for use in children, which was set at an average age of 9 years and older, although the range was age 2 years to 16 years.
NBUVB was used as a second-line therapy instead of systemic treatments in up to 93% of adults and in 69% of children. It was used concomitantly with systemic treatment in up to 58% of adults and 11% of children, according to the survey responses.
For about 70% of respondents, the use of NB-UVB was determined by assessing the Fitzpatrick skin type, although almost 40% relied on clinical experience.
Frequency of treatment
NB-UVB was prescribed three times a week by 59% of respondents; 31% of respondents prescribed it twice a week; 7%, five times per week; and 2%, four times a week. The typical number of treatments was 21-30 for 53% of respondents, 0-20 treatments for 24%, and 31-40 treatments for 20%.
The dose was typically increased in 10% increments, although there were wide variations in how the treatment was stepped up. Dose was increased after each treatment by almost 50% of respondents, after every two treatments by almost 25%, and after every three treatments by approximately 15%.
For the majority (53%) of respondents, response to NBUVB was assessed after 7-15 treatments, while 43% waited until after 16-30 treatments. Success was defined as a 75% reduction in eczema from baseline by 56% of respondents, while 54% looked to patient satisfaction, and 47% relied on quality of life to determine success of treatment.
Maintenance NB-UVB was never used by 54% of respondents, but 44% said they used it occasionally, and 83% said they did not follow a weaning schedule at the end of treatment.
The most commonly reported adverse effects of NB-UVB were significant erythema, hyperpigmentation, and eczema flare, while the most commonly cited absolute contraindications included a history of melanoma, a history of squamous cell carcinoma, the use of photosensitizing medications, and claustrophobia.
Use of PUVA, UVA1
The next most commonly used phototherapy for atopic eczema was PUVA. Although it was available to 83% of respondents, only 52% of respondents had personally prescribed the treatment for adults, and only 7% prescribed it for children.
Of the respondents, 71% said they would switch from NB-UVB to PUVA if desired treatment outcomes were not achieved with the former, and 44% said they would “sometimes consider” PUVA as second-line therapy instead of systemic treatments. Only 13% said they would use it concomitantly with systemic treatment.
Ultraviolet A1 (UVA1) phototherapy was not widely available, with 66% of respondents declaring that they did not have access to this option and just 29% saying they prescribed it.
But when it was used, UVA1 was cited as being used often in adults by 24% of respondents, while 33% used it was used sometimes, and 43% said it was used rarely. It was used for children by 26% of respondents. In addition, 29% said they favored using UVA1 for chronic atopic eczema, and 33% favored using it for acute eczema while 38% had no preference over whether to use it for chronic versus acute atopic eczema.
Similarly to NB-UVB, there were wide variations in the use of PUVA and UVA1 by respondents in terms of dosing schedules, duration of treatment, and how response to treatment was measured.
No funding for the study has been reported. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
GLASGOW, Scotland – , which points to the need for management guidelines.
Over 140 phototherapy practitioners from 27 European countries responded to the survey. Of the practitioners surveyed, 96% used narrow-band ultraviolet B (NB-UVB), and about 50% prescribed psoralen and ultraviolet A (PUVA) for adults. Fewer than 10% did so for children.
There was considerable variation in prescribing practices, “especially when it comes to dosing and treatment duration,” said study presenter Mia Steyn, MD, dermatology registrar, St. John’s Institute of Dermatology, Guy’s and St. Thomas’s Hospital, London.
These results, she said, demonstrate that “an optimal treatment modality either is not known or agreed upon” and that studies are required to determine treatment efficacy, cost, and safety “in a range of skin types.”
Dr. Steyn said that what is needed first is a set of consensus treatment guidelines, “hopefully leading to a randomized controlled trial” that would compare the various treatment options.
The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 7.
Session co-chair Adam Fityan, MD, a consultant dermatologist at University Hospital Southampton NHS Foundation Trust, U.K., commented that the study was “fascinating” and “really helpful.”
Dr. Fityan, who was not involved with the survey, told this news organization that, “clearly, what we’ve seen is that there is a huge variation in the way everyone uses the different modalities of phototherapy.”
“Having that sort of knowledge will hopefully help us to think a bit more clearly about the regimens and protocols that we use and to maybe find the evidence that everyone needs to have the most effective protocol.”
The data from the study are also useful on an individual level, Dr. Fityan continued, as “you have no idea what anyone is doing” and whether “you are an outlier.”
Dr. Steyn said that phototherapy is commonly used for the treatment of atopic eczema, but the evidence for its efficacy, its impact on quality on life, its cost-effectiveness, and short- and long-term safety is “weak,” particularly in relation to real-life use.
Electronic survey
In lieu of a well-designed randomized controlled trial to answer these questions, the researchers set up a task force to assess how phototherapy is currently being used to treat atopic eczema across the United Kingdom and Europe so as to guide further research.
An electronic survey was devised, and 144 members of phototherapy groups from 27 European countries submitted their responses during 2020. Most responses came from the Netherlands (20), Italy (16), the United Kingdom (14), France (11), and Germany (10).
The results showed that NB-UVB was the most widely used modality of phototherapy, chosen by 96% of respondents. In addition, 17% of respondents said they also prescribed home-based NB-UVB, which was available in eight of the 27 countries.
When asked how they used NB-UVB, the majority (68%) of respondents said they had an age cutoff for use in children, which was set at an average age of 9 years and older, although the range was age 2 years to 16 years.
NBUVB was used as a second-line therapy instead of systemic treatments in up to 93% of adults and in 69% of children. It was used concomitantly with systemic treatment in up to 58% of adults and 11% of children, according to the survey responses.
For about 70% of respondents, the use of NB-UVB was determined by assessing the Fitzpatrick skin type, although almost 40% relied on clinical experience.
Frequency of treatment
NB-UVB was prescribed three times a week by 59% of respondents; 31% of respondents prescribed it twice a week; 7%, five times per week; and 2%, four times a week. The typical number of treatments was 21-30 for 53% of respondents, 0-20 treatments for 24%, and 31-40 treatments for 20%.
The dose was typically increased in 10% increments, although there were wide variations in how the treatment was stepped up. Dose was increased after each treatment by almost 50% of respondents, after every two treatments by almost 25%, and after every three treatments by approximately 15%.
For the majority (53%) of respondents, response to NBUVB was assessed after 7-15 treatments, while 43% waited until after 16-30 treatments. Success was defined as a 75% reduction in eczema from baseline by 56% of respondents, while 54% looked to patient satisfaction, and 47% relied on quality of life to determine success of treatment.
Maintenance NB-UVB was never used by 54% of respondents, but 44% said they used it occasionally, and 83% said they did not follow a weaning schedule at the end of treatment.
The most commonly reported adverse effects of NB-UVB were significant erythema, hyperpigmentation, and eczema flare, while the most commonly cited absolute contraindications included a history of melanoma, a history of squamous cell carcinoma, the use of photosensitizing medications, and claustrophobia.
Use of PUVA, UVA1
The next most commonly used phototherapy for atopic eczema was PUVA. Although it was available to 83% of respondents, only 52% of respondents had personally prescribed the treatment for adults, and only 7% prescribed it for children.
Of the respondents, 71% said they would switch from NB-UVB to PUVA if desired treatment outcomes were not achieved with the former, and 44% said they would “sometimes consider” PUVA as second-line therapy instead of systemic treatments. Only 13% said they would use it concomitantly with systemic treatment.
Ultraviolet A1 (UVA1) phototherapy was not widely available, with 66% of respondents declaring that they did not have access to this option and just 29% saying they prescribed it.
But when it was used, UVA1 was cited as being used often in adults by 24% of respondents, while 33% used it was used sometimes, and 43% said it was used rarely. It was used for children by 26% of respondents. In addition, 29% said they favored using UVA1 for chronic atopic eczema, and 33% favored using it for acute eczema while 38% had no preference over whether to use it for chronic versus acute atopic eczema.
Similarly to NB-UVB, there were wide variations in the use of PUVA and UVA1 by respondents in terms of dosing schedules, duration of treatment, and how response to treatment was measured.
No funding for the study has been reported. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Zoster vaccination does not appear to increase flare risk in patients with immune-mediated inflammatory disease
, according to research published in Arthritis & Rheumatology.
The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.
The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.
They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.
Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.
Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.
Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.
“Anytime you are vaccinating a patient with an autoimmune disease, especially one on a biologic, you always worry about the risk of flares,” said Dr. Bose. “Any time you tamper with the immune system, there is a risk of flares.”
The study serves as a clarification for the primary care setting, said Dr. Bose. “A lot of the time, the shingles vaccine is administered not by rheumatology but by primary care or through the pharmacy,” she said. “This study puts them [primary care physicians] at ease.”
Findings from the study reflect that most RZV vaccinations were administered in pharmacies.
One of the weaknesses of the study is that the investigators did not include patients younger than 50 years old, said Dr. Bose. “It would have been nice if they could have looked at younger patients,” she said. “We try to vaccinate all our [immunocompromised] adult patients, even the younger ones, because they are also at risk for shingles.”
Given that there are increasing options of medical therapies in rheumatology that are immunomodulatory, the subject of vaccination for patients is often one of discussion, added Dr. Bose.
Arthur Kavanaugh, MD, professor of medicine, University of California San Diego (UCSD), La Jolla, Calif., and director of the Center for Innovative Therapy in the UCSD Division of Rheumatology, Allergy, and Immunology, told this news organization that a strength of the study is its large numbers of patients but noted the shortcoming of using claims data. “Claims data has inherent limitations, such as the lack of detailed granular data on the patients,” wrote Dr. Kavanaugh, who was not involved with the study. He described this investigation as “really about the first evidence that I am aware of addressing this issue.”
No funding source was listed. One author disclosed having received research grants and consulting fees received from Pfizer and GSK for unrelated work; the other authors had no disclosures. Dr. Bose and Dr. Kavanaugh had no relevant disclosures.
, according to research published in Arthritis & Rheumatology.
The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.
The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.
They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.
Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.
Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.
Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.
“Anytime you are vaccinating a patient with an autoimmune disease, especially one on a biologic, you always worry about the risk of flares,” said Dr. Bose. “Any time you tamper with the immune system, there is a risk of flares.”
The study serves as a clarification for the primary care setting, said Dr. Bose. “A lot of the time, the shingles vaccine is administered not by rheumatology but by primary care or through the pharmacy,” she said. “This study puts them [primary care physicians] at ease.”
Findings from the study reflect that most RZV vaccinations were administered in pharmacies.
One of the weaknesses of the study is that the investigators did not include patients younger than 50 years old, said Dr. Bose. “It would have been nice if they could have looked at younger patients,” she said. “We try to vaccinate all our [immunocompromised] adult patients, even the younger ones, because they are also at risk for shingles.”
Given that there are increasing options of medical therapies in rheumatology that are immunomodulatory, the subject of vaccination for patients is often one of discussion, added Dr. Bose.
Arthur Kavanaugh, MD, professor of medicine, University of California San Diego (UCSD), La Jolla, Calif., and director of the Center for Innovative Therapy in the UCSD Division of Rheumatology, Allergy, and Immunology, told this news organization that a strength of the study is its large numbers of patients but noted the shortcoming of using claims data. “Claims data has inherent limitations, such as the lack of detailed granular data on the patients,” wrote Dr. Kavanaugh, who was not involved with the study. He described this investigation as “really about the first evidence that I am aware of addressing this issue.”
No funding source was listed. One author disclosed having received research grants and consulting fees received from Pfizer and GSK for unrelated work; the other authors had no disclosures. Dr. Bose and Dr. Kavanaugh had no relevant disclosures.
, according to research published in Arthritis & Rheumatology.
The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.
The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.
They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.
Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.
Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.
Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.
“Anytime you are vaccinating a patient with an autoimmune disease, especially one on a biologic, you always worry about the risk of flares,” said Dr. Bose. “Any time you tamper with the immune system, there is a risk of flares.”
The study serves as a clarification for the primary care setting, said Dr. Bose. “A lot of the time, the shingles vaccine is administered not by rheumatology but by primary care or through the pharmacy,” she said. “This study puts them [primary care physicians] at ease.”
Findings from the study reflect that most RZV vaccinations were administered in pharmacies.
One of the weaknesses of the study is that the investigators did not include patients younger than 50 years old, said Dr. Bose. “It would have been nice if they could have looked at younger patients,” she said. “We try to vaccinate all our [immunocompromised] adult patients, even the younger ones, because they are also at risk for shingles.”
Given that there are increasing options of medical therapies in rheumatology that are immunomodulatory, the subject of vaccination for patients is often one of discussion, added Dr. Bose.
Arthur Kavanaugh, MD, professor of medicine, University of California San Diego (UCSD), La Jolla, Calif., and director of the Center for Innovative Therapy in the UCSD Division of Rheumatology, Allergy, and Immunology, told this news organization that a strength of the study is its large numbers of patients but noted the shortcoming of using claims data. “Claims data has inherent limitations, such as the lack of detailed granular data on the patients,” wrote Dr. Kavanaugh, who was not involved with the study. He described this investigation as “really about the first evidence that I am aware of addressing this issue.”
No funding source was listed. One author disclosed having received research grants and consulting fees received from Pfizer and GSK for unrelated work; the other authors had no disclosures. Dr. Bose and Dr. Kavanaugh had no relevant disclosures.
Docs reveal perils of giving medical advice to friends and family
Stephen Pribut, DPM, a sports medicine podiatrist based in Washington, has had many friends or family members ask him for medical advice. It’s a scenario every doctor will face at one point or another in their careers, and it’s never an easy one.
Dr. Pribut received a call from a friend about a sore shoulder from swimming, saying that his doctor had dismissed the potential for a rotator cuff injury. “Months later, images revealed it was a rotator cuff tear and he wanted my advice,” says Dr. Pribut.
Not being a shoulder specialist, Dr. Pribut limited his input. “I told him to consider a good physical therapist or a shoulder specialist and gave him some alternative strokes for swimming that hopefully wouldn’t aggravate the injury,” he explains.
But he admits some situations are challenging. “I had a relative asking about a third party with an ankle injury. I advised he hold off on using a balance board until things healed, and to make sure he went to see a specialist. Unfortunately, he went to his general practitioner who likely knows nothing about ankle anatomy,” says Dr. Pribut.
“I finally saw a photo, which revealed swelling higher up on the ankle and no evidence of a hematoma – much lower than we would see in an ankle ligament injury. I would like him to see a sports podiatrist or foot and ankle orthopedist, but now I have to stay calm when the advice isn’t followed,” he says.
When asked, “Do you give medical advice to your friends?” 96% of respondents answered yes.
Yazan Abou-Ismail, MD, assistant professor of medicine in the division of hematology at the University of Utah, Salt Lake City, has often faced questions from friends and family, particularly throughout the COVID-19 pandemic. “How you respond is something all physicians need to analyze carefully,” he says. “I get questions on a regular basis, but this greatly increased with COVID.”
“Sharing general information is okay, and it’s even a requirement that we educate on such topics,” says Dr. Abou-Ismail. “But if someone knows they have COVID, for instance, and wants advice on how to proceed, it’s important to send them to their primary care physician for an evaluation rather than give them instructions on care.”
Dr. Abou-Ismail says that most “curbside consulting” equates to lack of an ethical follow-up. “If you gave medical advice without having assessed them, you’re lacking the medical history, a physical exam, and you should not be giving advice,” he says. “This applies to follow-ups, too.”
Throughout the pandemic, Dr. Abou-Ismail’s requests for advice on COVID even extended to online inquiries, often from strangers. “This is not a place to do a formal assessment,” he reminds. “But there are certain types of advice you can offer appropriately.”
Dr. Abou-Ismail considers safe advice to be simple public health messages that stay far out of specifics. Things like “don’t smoke,” or “eat a healthy diet,” and “get enough sleep,” fall into this safety zone. Even, “What is XYZ disease?” or “How do COVID vaccines work?” are topics he says he answers comfortably.
“But telling someone you need a specific treatment for a condition is inappropriate,” he explains. “This is a general way of practicing medicine – your advice should never venture into the potential of doing harm.”
This approach is exactly in line with legal advice, according to Jeff Caesar Chukwuma, founder and senior partner at Chukwuma Law Group, Miami. “It doesn’t mean that doctors should never give medical advice to friends or family, but if they do, they should make sure to take several precautions to protect both themselves and their family and friends,” he says.
When the request for medical advice from an acquaintance migrates into areas in which a physician is not a specialist, sharing recommendations gets even trickier – and more ethically questionable.
Says Mr. Chukwuma, “Doctors should avoid giving advice in areas outside their area of expertise to lower the possibility of providing erroneous or harmful information,” he says.
How to stay safe when asked for advice
The American Medical Association has weighed in on the topic. In the Code of Medical Ethics Opinion 1.2.1, the AMA states that, “Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.”
What about friends or acquaintances, however?
Even so, some respondents voiced their concerns with the scenario. Responses like, “Due to ethics, I would prefer they go and get first, second, and third opinions,” and “Usually the medical advice is very basic first aid (often mental health first aid), and if it’s anything remotely more complicated, I direct them to the appropriate provider.”
The AMA places advising friends in the same basket as advising and treating family members or oneself. In an article appearing in the AMA Journal of Ethics, Horacio Hojman, MD, of Tufts University School of Medicine, Boston, weighed in: “First and foremost, patients deserve objectivity from their doctors. When a physician is emotionally involved with a patient, that physician’s objectivity can be called into question.”
Why is medical advice so thorny when dealing with friends or relatives?
In some cases, a physician might not ask a friend relevant personal questions about his or her medical history, for instance. Or the friend might not want to share details with the doctor. In either case, the lack of information exchange can lead to improper advice.
The issue of giving medical advice to friends, family, and acquaintances can also wade into legal territory. “Personally or professionally, trust is the decisive factor that puts us at ease with the people we surround ourselves with,” says Mr. Chukwuma. “Nowhere is this truer than in medicine, where we approach doctors with some of the most sensitive matters in our lives and entrust our care to them, especially when the physician in question is a close friend or family member.”
Mr. Chukwuma points out that, while there are few strict legal prohibitions against doctors providing care or advice to family and friends, the AMA’s code of ethics states that such action should be reserved for rare situations, such as emergency settings or isolated settings where there is no other qualified physician available, or for minor, not long-term problems.
This was part of the equation for Dr. Pribut when helping his mother navigate her treatment for breast cancer. “With close relatives, offering advice and help can be very hard,” he says.
“This is to protect both patients and doctors,” says Mr. Chukwuma. “Although seeking advice from a family member or friend who is a doctor may be more convenient for a patient, they run the risk of receiving inadequate care by not going in for a formal medical visit complete with tests, medical examination, and follow-up care.”
Mr. Chukwuma offers guidance on how to share medical advice ethically and legally with family, friends, and acquaintances. “First, as much as possible, speak to general medical facts and knowledge rather than comment directly on the patient’s particular situation,” he says. “In the absence of thorough examination and tests, the doctor’s knowledge of a patient’s condition is limited, therefore, you should take care not to provide seemingly definitive answers on that patient’s unique condition in situations where they can’t rely on data to back up their advice and recommendations.”
The AMA’s Journal of Ethics article shares these tips for staying on the right side of the ethical line when dealing with friends and family members:
- Politely decline.
- Offer other forms of assistance – this might help a friend find the right qualified physician – as Dr. Pribut tends to do. Maybe help in navigating the sometimes-confusing health care system.
- Don’t hesitate in an emergency – the old “is there a doctor on board,” scenario on a plane when someone is in distress is a perfectly acceptable, and recommended, time to step in, even if it is a friend or family member.
Dr. Pribut, a long-time veteran of the tricky medical waters involving friends and family, has this to offer: “Be cautious and always stay in the realm of what you know,” he says. “Always encourage people to seek an opinion from a qualified doctor. Help them find a reputable doctor if that’s useful.”
Mr. Chukwuma adds also that doctors should stand firm when pushed by a friend or family member, especially when offering advice, even if it’s in the form of general education. “The doctor should make it clear to the family member or friend that their advice in no way takes the place of actual treatment or examination by a medical professional and that, if need be, the patient should seek formal medical help from another doctor, ideally one not related to or friends with the patient,” he says.
A version of this article first appeared on Medscape.com.
Stephen Pribut, DPM, a sports medicine podiatrist based in Washington, has had many friends or family members ask him for medical advice. It’s a scenario every doctor will face at one point or another in their careers, and it’s never an easy one.
Dr. Pribut received a call from a friend about a sore shoulder from swimming, saying that his doctor had dismissed the potential for a rotator cuff injury. “Months later, images revealed it was a rotator cuff tear and he wanted my advice,” says Dr. Pribut.
Not being a shoulder specialist, Dr. Pribut limited his input. “I told him to consider a good physical therapist or a shoulder specialist and gave him some alternative strokes for swimming that hopefully wouldn’t aggravate the injury,” he explains.
But he admits some situations are challenging. “I had a relative asking about a third party with an ankle injury. I advised he hold off on using a balance board until things healed, and to make sure he went to see a specialist. Unfortunately, he went to his general practitioner who likely knows nothing about ankle anatomy,” says Dr. Pribut.
“I finally saw a photo, which revealed swelling higher up on the ankle and no evidence of a hematoma – much lower than we would see in an ankle ligament injury. I would like him to see a sports podiatrist or foot and ankle orthopedist, but now I have to stay calm when the advice isn’t followed,” he says.
When asked, “Do you give medical advice to your friends?” 96% of respondents answered yes.
Yazan Abou-Ismail, MD, assistant professor of medicine in the division of hematology at the University of Utah, Salt Lake City, has often faced questions from friends and family, particularly throughout the COVID-19 pandemic. “How you respond is something all physicians need to analyze carefully,” he says. “I get questions on a regular basis, but this greatly increased with COVID.”
“Sharing general information is okay, and it’s even a requirement that we educate on such topics,” says Dr. Abou-Ismail. “But if someone knows they have COVID, for instance, and wants advice on how to proceed, it’s important to send them to their primary care physician for an evaluation rather than give them instructions on care.”
Dr. Abou-Ismail says that most “curbside consulting” equates to lack of an ethical follow-up. “If you gave medical advice without having assessed them, you’re lacking the medical history, a physical exam, and you should not be giving advice,” he says. “This applies to follow-ups, too.”
Throughout the pandemic, Dr. Abou-Ismail’s requests for advice on COVID even extended to online inquiries, often from strangers. “This is not a place to do a formal assessment,” he reminds. “But there are certain types of advice you can offer appropriately.”
Dr. Abou-Ismail considers safe advice to be simple public health messages that stay far out of specifics. Things like “don’t smoke,” or “eat a healthy diet,” and “get enough sleep,” fall into this safety zone. Even, “What is XYZ disease?” or “How do COVID vaccines work?” are topics he says he answers comfortably.
“But telling someone you need a specific treatment for a condition is inappropriate,” he explains. “This is a general way of practicing medicine – your advice should never venture into the potential of doing harm.”
This approach is exactly in line with legal advice, according to Jeff Caesar Chukwuma, founder and senior partner at Chukwuma Law Group, Miami. “It doesn’t mean that doctors should never give medical advice to friends or family, but if they do, they should make sure to take several precautions to protect both themselves and their family and friends,” he says.
When the request for medical advice from an acquaintance migrates into areas in which a physician is not a specialist, sharing recommendations gets even trickier – and more ethically questionable.
Says Mr. Chukwuma, “Doctors should avoid giving advice in areas outside their area of expertise to lower the possibility of providing erroneous or harmful information,” he says.
How to stay safe when asked for advice
The American Medical Association has weighed in on the topic. In the Code of Medical Ethics Opinion 1.2.1, the AMA states that, “Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.”
What about friends or acquaintances, however?
Even so, some respondents voiced their concerns with the scenario. Responses like, “Due to ethics, I would prefer they go and get first, second, and third opinions,” and “Usually the medical advice is very basic first aid (often mental health first aid), and if it’s anything remotely more complicated, I direct them to the appropriate provider.”
The AMA places advising friends in the same basket as advising and treating family members or oneself. In an article appearing in the AMA Journal of Ethics, Horacio Hojman, MD, of Tufts University School of Medicine, Boston, weighed in: “First and foremost, patients deserve objectivity from their doctors. When a physician is emotionally involved with a patient, that physician’s objectivity can be called into question.”
Why is medical advice so thorny when dealing with friends or relatives?
In some cases, a physician might not ask a friend relevant personal questions about his or her medical history, for instance. Or the friend might not want to share details with the doctor. In either case, the lack of information exchange can lead to improper advice.
The issue of giving medical advice to friends, family, and acquaintances can also wade into legal territory. “Personally or professionally, trust is the decisive factor that puts us at ease with the people we surround ourselves with,” says Mr. Chukwuma. “Nowhere is this truer than in medicine, where we approach doctors with some of the most sensitive matters in our lives and entrust our care to them, especially when the physician in question is a close friend or family member.”
Mr. Chukwuma points out that, while there are few strict legal prohibitions against doctors providing care or advice to family and friends, the AMA’s code of ethics states that such action should be reserved for rare situations, such as emergency settings or isolated settings where there is no other qualified physician available, or for minor, not long-term problems.
This was part of the equation for Dr. Pribut when helping his mother navigate her treatment for breast cancer. “With close relatives, offering advice and help can be very hard,” he says.
“This is to protect both patients and doctors,” says Mr. Chukwuma. “Although seeking advice from a family member or friend who is a doctor may be more convenient for a patient, they run the risk of receiving inadequate care by not going in for a formal medical visit complete with tests, medical examination, and follow-up care.”
Mr. Chukwuma offers guidance on how to share medical advice ethically and legally with family, friends, and acquaintances. “First, as much as possible, speak to general medical facts and knowledge rather than comment directly on the patient’s particular situation,” he says. “In the absence of thorough examination and tests, the doctor’s knowledge of a patient’s condition is limited, therefore, you should take care not to provide seemingly definitive answers on that patient’s unique condition in situations where they can’t rely on data to back up their advice and recommendations.”
The AMA’s Journal of Ethics article shares these tips for staying on the right side of the ethical line when dealing with friends and family members:
- Politely decline.
- Offer other forms of assistance – this might help a friend find the right qualified physician – as Dr. Pribut tends to do. Maybe help in navigating the sometimes-confusing health care system.
- Don’t hesitate in an emergency – the old “is there a doctor on board,” scenario on a plane when someone is in distress is a perfectly acceptable, and recommended, time to step in, even if it is a friend or family member.
Dr. Pribut, a long-time veteran of the tricky medical waters involving friends and family, has this to offer: “Be cautious and always stay in the realm of what you know,” he says. “Always encourage people to seek an opinion from a qualified doctor. Help them find a reputable doctor if that’s useful.”
Mr. Chukwuma adds also that doctors should stand firm when pushed by a friend or family member, especially when offering advice, even if it’s in the form of general education. “The doctor should make it clear to the family member or friend that their advice in no way takes the place of actual treatment or examination by a medical professional and that, if need be, the patient should seek formal medical help from another doctor, ideally one not related to or friends with the patient,” he says.
A version of this article first appeared on Medscape.com.
Stephen Pribut, DPM, a sports medicine podiatrist based in Washington, has had many friends or family members ask him for medical advice. It’s a scenario every doctor will face at one point or another in their careers, and it’s never an easy one.
Dr. Pribut received a call from a friend about a sore shoulder from swimming, saying that his doctor had dismissed the potential for a rotator cuff injury. “Months later, images revealed it was a rotator cuff tear and he wanted my advice,” says Dr. Pribut.
Not being a shoulder specialist, Dr. Pribut limited his input. “I told him to consider a good physical therapist or a shoulder specialist and gave him some alternative strokes for swimming that hopefully wouldn’t aggravate the injury,” he explains.
But he admits some situations are challenging. “I had a relative asking about a third party with an ankle injury. I advised he hold off on using a balance board until things healed, and to make sure he went to see a specialist. Unfortunately, he went to his general practitioner who likely knows nothing about ankle anatomy,” says Dr. Pribut.
“I finally saw a photo, which revealed swelling higher up on the ankle and no evidence of a hematoma – much lower than we would see in an ankle ligament injury. I would like him to see a sports podiatrist or foot and ankle orthopedist, but now I have to stay calm when the advice isn’t followed,” he says.
When asked, “Do you give medical advice to your friends?” 96% of respondents answered yes.
Yazan Abou-Ismail, MD, assistant professor of medicine in the division of hematology at the University of Utah, Salt Lake City, has often faced questions from friends and family, particularly throughout the COVID-19 pandemic. “How you respond is something all physicians need to analyze carefully,” he says. “I get questions on a regular basis, but this greatly increased with COVID.”
“Sharing general information is okay, and it’s even a requirement that we educate on such topics,” says Dr. Abou-Ismail. “But if someone knows they have COVID, for instance, and wants advice on how to proceed, it’s important to send them to their primary care physician for an evaluation rather than give them instructions on care.”
Dr. Abou-Ismail says that most “curbside consulting” equates to lack of an ethical follow-up. “If you gave medical advice without having assessed them, you’re lacking the medical history, a physical exam, and you should not be giving advice,” he says. “This applies to follow-ups, too.”
Throughout the pandemic, Dr. Abou-Ismail’s requests for advice on COVID even extended to online inquiries, often from strangers. “This is not a place to do a formal assessment,” he reminds. “But there are certain types of advice you can offer appropriately.”
Dr. Abou-Ismail considers safe advice to be simple public health messages that stay far out of specifics. Things like “don’t smoke,” or “eat a healthy diet,” and “get enough sleep,” fall into this safety zone. Even, “What is XYZ disease?” or “How do COVID vaccines work?” are topics he says he answers comfortably.
“But telling someone you need a specific treatment for a condition is inappropriate,” he explains. “This is a general way of practicing medicine – your advice should never venture into the potential of doing harm.”
This approach is exactly in line with legal advice, according to Jeff Caesar Chukwuma, founder and senior partner at Chukwuma Law Group, Miami. “It doesn’t mean that doctors should never give medical advice to friends or family, but if they do, they should make sure to take several precautions to protect both themselves and their family and friends,” he says.
When the request for medical advice from an acquaintance migrates into areas in which a physician is not a specialist, sharing recommendations gets even trickier – and more ethically questionable.
Says Mr. Chukwuma, “Doctors should avoid giving advice in areas outside their area of expertise to lower the possibility of providing erroneous or harmful information,” he says.
How to stay safe when asked for advice
The American Medical Association has weighed in on the topic. In the Code of Medical Ethics Opinion 1.2.1, the AMA states that, “Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.”
What about friends or acquaintances, however?
Even so, some respondents voiced their concerns with the scenario. Responses like, “Due to ethics, I would prefer they go and get first, second, and third opinions,” and “Usually the medical advice is very basic first aid (often mental health first aid), and if it’s anything remotely more complicated, I direct them to the appropriate provider.”
The AMA places advising friends in the same basket as advising and treating family members or oneself. In an article appearing in the AMA Journal of Ethics, Horacio Hojman, MD, of Tufts University School of Medicine, Boston, weighed in: “First and foremost, patients deserve objectivity from their doctors. When a physician is emotionally involved with a patient, that physician’s objectivity can be called into question.”
Why is medical advice so thorny when dealing with friends or relatives?
In some cases, a physician might not ask a friend relevant personal questions about his or her medical history, for instance. Or the friend might not want to share details with the doctor. In either case, the lack of information exchange can lead to improper advice.
The issue of giving medical advice to friends, family, and acquaintances can also wade into legal territory. “Personally or professionally, trust is the decisive factor that puts us at ease with the people we surround ourselves with,” says Mr. Chukwuma. “Nowhere is this truer than in medicine, where we approach doctors with some of the most sensitive matters in our lives and entrust our care to them, especially when the physician in question is a close friend or family member.”
Mr. Chukwuma points out that, while there are few strict legal prohibitions against doctors providing care or advice to family and friends, the AMA’s code of ethics states that such action should be reserved for rare situations, such as emergency settings or isolated settings where there is no other qualified physician available, or for minor, not long-term problems.
This was part of the equation for Dr. Pribut when helping his mother navigate her treatment for breast cancer. “With close relatives, offering advice and help can be very hard,” he says.
“This is to protect both patients and doctors,” says Mr. Chukwuma. “Although seeking advice from a family member or friend who is a doctor may be more convenient for a patient, they run the risk of receiving inadequate care by not going in for a formal medical visit complete with tests, medical examination, and follow-up care.”
Mr. Chukwuma offers guidance on how to share medical advice ethically and legally with family, friends, and acquaintances. “First, as much as possible, speak to general medical facts and knowledge rather than comment directly on the patient’s particular situation,” he says. “In the absence of thorough examination and tests, the doctor’s knowledge of a patient’s condition is limited, therefore, you should take care not to provide seemingly definitive answers on that patient’s unique condition in situations where they can’t rely on data to back up their advice and recommendations.”
The AMA’s Journal of Ethics article shares these tips for staying on the right side of the ethical line when dealing with friends and family members:
- Politely decline.
- Offer other forms of assistance – this might help a friend find the right qualified physician – as Dr. Pribut tends to do. Maybe help in navigating the sometimes-confusing health care system.
- Don’t hesitate in an emergency – the old “is there a doctor on board,” scenario on a plane when someone is in distress is a perfectly acceptable, and recommended, time to step in, even if it is a friend or family member.
Dr. Pribut, a long-time veteran of the tricky medical waters involving friends and family, has this to offer: “Be cautious and always stay in the realm of what you know,” he says. “Always encourage people to seek an opinion from a qualified doctor. Help them find a reputable doctor if that’s useful.”
Mr. Chukwuma adds also that doctors should stand firm when pushed by a friend or family member, especially when offering advice, even if it’s in the form of general education. “The doctor should make it clear to the family member or friend that their advice in no way takes the place of actual treatment or examination by a medical professional and that, if need be, the patient should seek formal medical help from another doctor, ideally one not related to or friends with the patient,” he says.
A version of this article first appeared on Medscape.com.