MDedge Pediatrics

In the wake of the COVID-19 pandemic, the American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics, and Children’s Hospital Association declared a national emergency in child and adolescent mental health. Additionally, the U.S. Surgeon General issued an advisory highlighting increased prevalence of mental health challenges in youth, impacts of the COVID-19 pandemic, and recommendations to address this crisis.

The pandemic required youth to isolate from peers and community supports, navigate remote learning environments, and cope with grief and loss; some 140,000 children in the United States experienced the death of a caregiver due to COVID-19.¹ Virtually every system that supports children was affected. Whereas schools have historically been a main provider of child and adolescent mental health services, delivery of many school-based mental health programs was disrupted by school closures and staffing challenges. Subgroups of children (for example, those with intellectual and developmental disabilities) were particularly affected by these disruptions to daily life, and their use of emergency services increased.² Surges in psychiatric emergency department visits among children led to increased boarding, reflecting unleveraged opportunities for early intervention. Families faced changes in child care, economic uncertainty, educational responsibilities, and increased rates of domestic violence.³ Communities of color were disproportionately affected in every way, from disease mortality to learning loss and increased school dropout rates.

Meaningful improvement in children’s mental health will require remodeling broken systems to ensure that children are supported early, effectively, and equitably. To address gaps in the system, we must leverage school-based mental health programs, bolster access to and support of primary care providers, and embrace new, innovative models.
 

School-based mental health programs

Schools may be an ideal setting for universal mental health screening and opportunities for training, leadership, and whole school interventions. There is promising evidence that school-based interventions can decrease the incidence of suicide attempts and increase help-seeking behavior in students.⁴ There has long been interest in mental health screening in schools, though it has not been widely implemented given the significant resources required to both facilitate screening and effectively serve students who need additional support. Mobile apps may be one solution to scalability of both screening and interventions, but these initiatives should only be implemented within a stakeholder-engaged, family-centered multi-tiered model of behavioral support.

Other school-based initiatives include providing advice and training to teachers and school counselors and increasing access to specialized mental health professionals, including school psychologists, social workers, nurses, and behavior support workers, as well as community-based mental health providers. The 2021 American Rescue Plan Act included $170 billion for school funding, which many schools used to hire mental health workers. The Student Mental Health Helpline Act, if passed, will create helplines to support teachers as they help students address mental health issues.⁵ Educators can be trained to identify mental health needs, addressing mild symptoms themselves and referring students requiring more specialized services. Specific training programs for educators include Classroom Well-Being Information and Strategies for Educators (WISE), Youth Mental Health First Aid, and other resources funded by the U.S. Department of Health and Human Services. In addition to educators, other non–mental health professions interfacing with youth, including other youth, parents, clergy, coaches, and other community members, can be empowered with additional behavioral health knowledge and skills.
 

Increasing capacity in primary care

A number of programs are designed to improve knowledge and skills in children’s mental health among primary care providers, such as pediatricians. In Project ECHO, a “hub” of specialists, typically at an academic medical center, provides didactic lectures and case presentations for primary care “spokes” using teleconferencing.⁶ The REACH Institute uses interactive group learning followed by ongoing coaching and case-based training.

Collaborative care models known as Child Psychiatry Access Programs (CPAPs) engage child and adolescent psychiatrists to support primary care management of psychiatric disorders. Consultations may be direct or indirect, and involve technology or in-person care. Available in most states, these models increase access to mental health care, expand the capacity of the existing workforce, and decrease stigma and inconvenience for patients. Collaborative care models have been shown to lead to improved patient and family satisfaction, reduced utilization of emergency room and inpatient hospitalizations, and improved clinical outcomes. Off-site integrated care models may additionally serve larger and more geographically dispersed populations, minimize changes to existing infrastructure, reduce travel costs for clinicians, and decrease isolation of specialists. These programs are feasible, desirable, and sustainable. There is currently no cost to patients for their primary care providers’ participation in these models, as they are supported by the state, local, or insurance payer sources in addition to federal funding. Financially sustainable models are essential to ensure equitable access to these services in the future.
 

New service models

For adolescents and young adults, integrated youth service hubs such as those that have emerged in Australia, the United Kingdom, Canada, and more recently in the United States may be particularly appealing. These hubs emphasize rapid access to care and early intervention, youth and family engagement, youth-friendly settings and services, evidence-informed approaches, and partnerships and collaboration.⁷ In addition to mental health, these “one-stop shops” offer physical health, vocational supports, and case management to support basic needs. They address a particular system gap by providing services for transition-age youth rather than cutting off at age 18, as many children’s mental health services do.

Emerging solutions to the high utilization of emergency departments for pediatric mental health needs include utilization of pediatric Crisis Stabilization Units (CSUs). CSUs are community-based, short-term outpatient units that provide immediate care to children and families experiencing a mental health crisis. The goal of CSUs is to quickly stabilize the individual – often within 72 hours – and refer that individual to available community resources. This model may also reduce police involvement in mental health crises, which may be particularly important for racialized populations.
 

Conclusion

The thoughtful implementation and stable funding of evidence-based models can help schools, the health care system, and communities more effectively support children’s mental health in the post–COVID-19 pandemic era. Only with sufficient investments in the mental health system and other systems designed to support children and families, as well as careful consideration of unintended consequences on equity-deserving populations, will we see an end to this crisis.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences; program director of the child and adolescent psychiatry fellowship; and associate medical director of the perinatal program at the University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior.

References

1. Hillis SD et al. COVID-19–Associated orphanhood and caregiver death in the United States. Pediatrics. 2021;148:e2021053760.

2. Edgcomb JB et al. Mental health‐related emergency department visits among children during the early COVID‐19 pandemic. Psychiatr Res Clin Pract. 2022;4:4-11.

3. Pereda N, Díaz-Faes DA. Family violence against children in the wake of COVID-19 pandemic: A review of current perspectives and risk factors. Child and Adolescent Psychiatry and Mental Health. 2020;4:40.

4. Gijzen MWM et al. Effectiveness of school-based preventive programs in suicidal thoughts and behaviors: A meta-analysis. Journal of Affective Disorders. 2022;298:408-420.

5. Newman M: H.R.5235 – 117th Congress (2021-2022): Student Mental Health Helpline Act of 2021 [Internet] 2021; [cited 2023 Jan 11] Available from: http://www.congress.gov.

6. Raney L et al. Digitally driven integrated primary care and behavioral health: How technology can expand access to effective treatment. Curr Psychiatry Rep. 2017;19:86.

7. Settipani CA et al. Key attributes of integrated community-based youth service hubs for mental health: A scoping review. Int J Ment Health Syst. 2019;13:52.

In the wake of the COVID-19 pandemic, the American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics, and Children’s Hospital Association declared a national emergency in child and adolescent mental health. Additionally, the U.S. Surgeon General issued an advisory highlighting increased prevalence of mental health challenges in youth, impacts of the COVID-19 pandemic, and recommendations to address this crisis.

The pandemic required youth to isolate from peers and community supports, navigate remote learning environments, and cope with grief and loss; some 140,000 children in the United States experienced the death of a caregiver due to COVID-19.¹ Virtually every system that supports children was affected. Whereas schools have historically been a main provider of child and adolescent mental health services, delivery of many school-based mental health programs was disrupted by school closures and staffing challenges. Subgroups of children (for example, those with intellectual and developmental disabilities) were particularly affected by these disruptions to daily life, and their use of emergency services increased.² Surges in psychiatric emergency department visits among children led to increased boarding, reflecting unleveraged opportunities for early intervention. Families faced changes in child care, economic uncertainty, educational responsibilities, and increased rates of domestic violence.³ Communities of color were disproportionately affected in every way, from disease mortality to learning loss and increased school dropout rates.

Meaningful improvement in children’s mental health will require remodeling broken systems to ensure that children are supported early, effectively, and equitably. To address gaps in the system, we must leverage school-based mental health programs, bolster access to and support of primary care providers, and embrace new, innovative models.
 

School-based mental health programs

Schools may be an ideal setting for universal mental health screening and opportunities for training, leadership, and whole school interventions. There is promising evidence that school-based interventions can decrease the incidence of suicide attempts and increase help-seeking behavior in students.⁴ There has long been interest in mental health screening in schools, though it has not been widely implemented given the significant resources required to both facilitate screening and effectively serve students who need additional support. Mobile apps may be one solution to scalability of both screening and interventions, but these initiatives should only be implemented within a stakeholder-engaged, family-centered multi-tiered model of behavioral support.

Other school-based initiatives include providing advice and training to teachers and school counselors and increasing access to specialized mental health professionals, including school psychologists, social workers, nurses, and behavior support workers, as well as community-based mental health providers. The 2021 American Rescue Plan Act included $170 billion for school funding, which many schools used to hire mental health workers. The Student Mental Health Helpline Act, if passed, will create helplines to support teachers as they help students address mental health issues.⁵ Educators can be trained to identify mental health needs, addressing mild symptoms themselves and referring students requiring more specialized services. Specific training programs for educators include Classroom Well-Being Information and Strategies for Educators (WISE), Youth Mental Health First Aid, and other resources funded by the U.S. Department of Health and Human Services. In addition to educators, other non–mental health professions interfacing with youth, including other youth, parents, clergy, coaches, and other community members, can be empowered with additional behavioral health knowledge and skills.
 

Increasing capacity in primary care

A number of programs are designed to improve knowledge and skills in children’s mental health among primary care providers, such as pediatricians. In Project ECHO, a “hub” of specialists, typically at an academic medical center, provides didactic lectures and case presentations for primary care “spokes” using teleconferencing.⁶ The REACH Institute uses interactive group learning followed by ongoing coaching and case-based training.

Collaborative care models known as Child Psychiatry Access Programs (CPAPs) engage child and adolescent psychiatrists to support primary care management of psychiatric disorders. Consultations may be direct or indirect, and involve technology or in-person care. Available in most states, these models increase access to mental health care, expand the capacity of the existing workforce, and decrease stigma and inconvenience for patients. Collaborative care models have been shown to lead to improved patient and family satisfaction, reduced utilization of emergency room and inpatient hospitalizations, and improved clinical outcomes. Off-site integrated care models may additionally serve larger and more geographically dispersed populations, minimize changes to existing infrastructure, reduce travel costs for clinicians, and decrease isolation of specialists. These programs are feasible, desirable, and sustainable. There is currently no cost to patients for their primary care providers’ participation in these models, as they are supported by the state, local, or insurance payer sources in addition to federal funding. Financially sustainable models are essential to ensure equitable access to these services in the future.
 

New service models

For adolescents and young adults, integrated youth service hubs such as those that have emerged in Australia, the United Kingdom, Canada, and more recently in the United States may be particularly appealing. These hubs emphasize rapid access to care and early intervention, youth and family engagement, youth-friendly settings and services, evidence-informed approaches, and partnerships and collaboration.⁷ In addition to mental health, these “one-stop shops” offer physical health, vocational supports, and case management to support basic needs. They address a particular system gap by providing services for transition-age youth rather than cutting off at age 18, as many children’s mental health services do.

Emerging solutions to the high utilization of emergency departments for pediatric mental health needs include utilization of pediatric Crisis Stabilization Units (CSUs). CSUs are community-based, short-term outpatient units that provide immediate care to children and families experiencing a mental health crisis. The goal of CSUs is to quickly stabilize the individual – often within 72 hours – and refer that individual to available community resources. This model may also reduce police involvement in mental health crises, which may be particularly important for racialized populations.
 

Conclusion

The thoughtful implementation and stable funding of evidence-based models can help schools, the health care system, and communities more effectively support children’s mental health in the post–COVID-19 pandemic era. Only with sufficient investments in the mental health system and other systems designed to support children and families, as well as careful consideration of unintended consequences on equity-deserving populations, will we see an end to this crisis.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences; program director of the child and adolescent psychiatry fellowship; and associate medical director of the perinatal program at the University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior.

References

1. Hillis SD et al. COVID-19–Associated orphanhood and caregiver death in the United States. Pediatrics. 2021;148:e2021053760.

2. Edgcomb JB et al. Mental health‐related emergency department visits among children during the early COVID‐19 pandemic. Psychiatr Res Clin Pract. 2022;4:4-11.

3. Pereda N, Díaz-Faes DA. Family violence against children in the wake of COVID-19 pandemic: A review of current perspectives and risk factors. Child and Adolescent Psychiatry and Mental Health. 2020;4:40.

4. Gijzen MWM et al. Effectiveness of school-based preventive programs in suicidal thoughts and behaviors: A meta-analysis. Journal of Affective Disorders. 2022;298:408-420.

5. Newman M: H.R.5235 – 117th Congress (2021-2022): Student Mental Health Helpline Act of 2021 [Internet] 2021; [cited 2023 Jan 11] Available from: http://www.congress.gov.

6. Raney L et al. Digitally driven integrated primary care and behavioral health: How technology can expand access to effective treatment. Curr Psychiatry Rep. 2017;19:86.

7. Settipani CA et al. Key attributes of integrated community-based youth service hubs for mental health: A scoping review. Int J Ment Health Syst. 2019;13:52.

In the wake of the COVID-19 pandemic, the American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics, and Children’s Hospital Association declared a national emergency in child and adolescent mental health. Additionally, the U.S. Surgeon General issued an advisory highlighting increased prevalence of mental health challenges in youth, impacts of the COVID-19 pandemic, and recommendations to address this crisis.

The pandemic required youth to isolate from peers and community supports, navigate remote learning environments, and cope with grief and loss; some 140,000 children in the United States experienced the death of a caregiver due to COVID-19.¹ Virtually every system that supports children was affected. Whereas schools have historically been a main provider of child and adolescent mental health services, delivery of many school-based mental health programs was disrupted by school closures and staffing challenges. Subgroups of children (for example, those with intellectual and developmental disabilities) were particularly affected by these disruptions to daily life, and their use of emergency services increased.² Surges in psychiatric emergency department visits among children led to increased boarding, reflecting unleveraged opportunities for early intervention. Families faced changes in child care, economic uncertainty, educational responsibilities, and increased rates of domestic violence.³ Communities of color were disproportionately affected in every way, from disease mortality to learning loss and increased school dropout rates.

Meaningful improvement in children’s mental health will require remodeling broken systems to ensure that children are supported early, effectively, and equitably. To address gaps in the system, we must leverage school-based mental health programs, bolster access to and support of primary care providers, and embrace new, innovative models.
 

School-based mental health programs

Schools may be an ideal setting for universal mental health screening and opportunities for training, leadership, and whole school interventions. There is promising evidence that school-based interventions can decrease the incidence of suicide attempts and increase help-seeking behavior in students.⁴ There has long been interest in mental health screening in schools, though it has not been widely implemented given the significant resources required to both facilitate screening and effectively serve students who need additional support. Mobile apps may be one solution to scalability of both screening and interventions, but these initiatives should only be implemented within a stakeholder-engaged, family-centered multi-tiered model of behavioral support.

Other school-based initiatives include providing advice and training to teachers and school counselors and increasing access to specialized mental health professionals, including school psychologists, social workers, nurses, and behavior support workers, as well as community-based mental health providers. The 2021 American Rescue Plan Act included $170 billion for school funding, which many schools used to hire mental health workers. The Student Mental Health Helpline Act, if passed, will create helplines to support teachers as they help students address mental health issues.⁵ Educators can be trained to identify mental health needs, addressing mild symptoms themselves and referring students requiring more specialized services. Specific training programs for educators include Classroom Well-Being Information and Strategies for Educators (WISE), Youth Mental Health First Aid, and other resources funded by the U.S. Department of Health and Human Services. In addition to educators, other non–mental health professions interfacing with youth, including other youth, parents, clergy, coaches, and other community members, can be empowered with additional behavioral health knowledge and skills.
 

Increasing capacity in primary care

A number of programs are designed to improve knowledge and skills in children’s mental health among primary care providers, such as pediatricians. In Project ECHO, a “hub” of specialists, typically at an academic medical center, provides didactic lectures and case presentations for primary care “spokes” using teleconferencing.⁶ The REACH Institute uses interactive group learning followed by ongoing coaching and case-based training.

Collaborative care models known as Child Psychiatry Access Programs (CPAPs) engage child and adolescent psychiatrists to support primary care management of psychiatric disorders. Consultations may be direct or indirect, and involve technology or in-person care. Available in most states, these models increase access to mental health care, expand the capacity of the existing workforce, and decrease stigma and inconvenience for patients. Collaborative care models have been shown to lead to improved patient and family satisfaction, reduced utilization of emergency room and inpatient hospitalizations, and improved clinical outcomes. Off-site integrated care models may additionally serve larger and more geographically dispersed populations, minimize changes to existing infrastructure, reduce travel costs for clinicians, and decrease isolation of specialists. These programs are feasible, desirable, and sustainable. There is currently no cost to patients for their primary care providers’ participation in these models, as they are supported by the state, local, or insurance payer sources in addition to federal funding. Financially sustainable models are essential to ensure equitable access to these services in the future.
 

New service models

For adolescents and young adults, integrated youth service hubs such as those that have emerged in Australia, the United Kingdom, Canada, and more recently in the United States may be particularly appealing. These hubs emphasize rapid access to care and early intervention, youth and family engagement, youth-friendly settings and services, evidence-informed approaches, and partnerships and collaboration.⁷ In addition to mental health, these “one-stop shops” offer physical health, vocational supports, and case management to support basic needs. They address a particular system gap by providing services for transition-age youth rather than cutting off at age 18, as many children’s mental health services do.

Emerging solutions to the high utilization of emergency departments for pediatric mental health needs include utilization of pediatric Crisis Stabilization Units (CSUs). CSUs are community-based, short-term outpatient units that provide immediate care to children and families experiencing a mental health crisis. The goal of CSUs is to quickly stabilize the individual – often within 72 hours – and refer that individual to available community resources. This model may also reduce police involvement in mental health crises, which may be particularly important for racialized populations.
 

Conclusion

The thoughtful implementation and stable funding of evidence-based models can help schools, the health care system, and communities more effectively support children’s mental health in the post–COVID-19 pandemic era. Only with sufficient investments in the mental health system and other systems designed to support children and families, as well as careful consideration of unintended consequences on equity-deserving populations, will we see an end to this crisis.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences; program director of the child and adolescent psychiatry fellowship; and associate medical director of the perinatal program at the University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior.

References

1. Hillis SD et al. COVID-19–Associated orphanhood and caregiver death in the United States. Pediatrics. 2021;148:e2021053760.

2. Edgcomb JB et al. Mental health‐related emergency department visits among children during the early COVID‐19 pandemic. Psychiatr Res Clin Pract. 2022;4:4-11.

3. Pereda N, Díaz-Faes DA. Family violence against children in the wake of COVID-19 pandemic: A review of current perspectives and risk factors. Child and Adolescent Psychiatry and Mental Health. 2020;4:40.

4. Gijzen MWM et al. Effectiveness of school-based preventive programs in suicidal thoughts and behaviors: A meta-analysis. Journal of Affective Disorders. 2022;298:408-420.

5. Newman M: H.R.5235 – 117th Congress (2021-2022): Student Mental Health Helpline Act of 2021 [Internet] 2021; [cited 2023 Jan 11] Available from: http://www.congress.gov.

6. Raney L et al. Digitally driven integrated primary care and behavioral health: How technology can expand access to effective treatment. Curr Psychiatry Rep. 2017;19:86.

7. Settipani CA et al. Key attributes of integrated community-based youth service hubs for mental health: A scoping review. Int J Ment Health Syst. 2019;13:52.

Whether you’ve decided to retire, relocate, or work for your local hospital, unwinding your practice will take time. Physicians can avoid mistakes by planning ahead and making a checklist for what to do and when to do it.

“Doctors shouldn’t assume everything takes care of itself. Many don’t think about compliance issues, patient abandonment, or accounts receivable that they need to keep open to collect from billing, which can occur months after the dates of service,” said David Zetter, president of Zetter HealthCare management consultants in Pennsylvania.

Debra Phairas, president of Practice and Liability Consultants, LLC, in California, suggests doctors start planning for the closing of their practice at least 90-120 days from their closing date.

“Many people and entities need to be notified,” said Ms. Phairas. The list includes patients, payers, vendors, employees, licensing boards, and federal and state agencies.

Medical societies may have specific bylaws that apply; malpractice carriers have rules about how long you should retain medical records; and some state laws require that you communicate that you’re closing in a newspaper, Mr. Zetter added.

Ms. Phairas recommends that physicians decide first whether they will sell their practice or if they’ll just shut it down. If they sell and the buyer is a doctor, they may want to provide transition assistance such as introducing patients and staff, she said. Otherwise, doctors may need to terminate their staff.

After doctors make that decision, Mr. Zetter and Ms. Phairas recommend taking these 12 steps to ensure that the process goes smoothly.
 

What to do 60-90 days out

1. Check your insurance contracts. The Centers for Medicare & Medicaid Services requires physicians to notify them 90 days after deciding to retire or withdraw from Medicare or Medicaid. Other payers may also require 90 days’ notice to terminate their contracts.

You’ll also need to provide payers with a forwarding address for sending payments after the office closes, and notify your malpractice insurance carrier and any other contracted insurance carriers such as workers’ compensation or employee benefit plans.

2. Buy “tail” coverage. Doctors can be sued for malpractice years after they close their practice so this provides coverage against claims reported after the liability policy expires.

3. Check your hospital contracts. Most hospitals where you have privileges require 90 days’ notice that you are closing the practice.

4. Arrange for safe storage of medical records. If you are selling your practice to another physician, that doctor can take charge of them, as long as you obtain a patient’s consent to transfer the medical records, said Ms. Phairas. Otherwise, the practice is required to make someone the guardian of the records after the practice closes, said Mr. Zetter. This allows patients at a later date to obtain copies of their records at a cost.

“This usually means printing all the records to PDF to be retained; otherwise, doctors have to continue to pay the license fee for the EMR software to access the records, and no practice is going to continue to pay this indefinitely,” said Mr. Zetter.

Check with your malpractice insurance carrier for how long they require medical records to be retained, which may vary for adult and pediatric records.

Ms. Phairas also advises doctors to keep their original records. “The biggest mistake doctors can make is to give patients all their records. Your chart is your best defense weapon in a liability claim.”
 

What to do 30-60 days out

5. Tell your staff. They should not hear that you’re retiring or leaving the practice from other people, said Ms. Phairas. But timing is important. “If you notify them too soon, they may look for another job. I recommend telling them about 45 days out and just before you notify patients, although you may want to tell the office manager sooner.”

Doctors may need help closing the practice and should consider offering the employees a severance bonus to stay until the end, said Ms. Phairas. If they do leave sooner, then you can hire temporary staff.

6. Notify patients to avoid any claims of abandonment. You should notify all active patients, which, depending on your state, can be any patient the physician has treated sometime in the past 12-36 months.

Some state laws require the notice to be published as an advertisement in the local newspaper and will say how far in advance it needs to be published and how long the ad needs to run. Notification also should be posted throughout the practice, and patients who call or visit should be given oral reminders.

“Your biggest expense will be mailing a letter to all patients,” said Mr. Zetter. The letter should include:

• The date of closing.
• The name(s) of the physicians taking over the practice (if applicable).
• Local physicians who would be willing to accept new patients.
• Instructions for how patients can obtain or transfer medical records (with a deadline for submitting record requests).
• How to contact the practice if patients and families have any concerns about the closing.

7. Notify your professional associations. These include your state medical board, credentialing organizations, and professional memberships. It’s critical to renew your license even if you plan to practice in other states. He recalled that one doctor let his license lapse and the medical board notified Medicaid that he was no longer licensed. “CMS went after him because he didn’t notify them that he was no longer operating in Washington. CMS shut him down in every state/territory. This interventional radiologist spent 3 years with two attorneys to get it resolved,” said Mr. Zetter.

8. Terminate any leases with landlords or try to negotiate renting the office space on a month-to-month basis until you close or sell, suggests Ms. Phairas. If the practice owns the space, the partners will need to decide if the space will be sold or leased to a new business.
 

What to do 30 days out

9. Notify referring physicians of when you plan to close your practice so they don’t send new patients after that date.

10. Send a letter to the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.

11. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close out your accounts.

12. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.

Mr. Zetter also suggested retaining a certified accountant to handle the expenses for shutting down the business and to handle your future tax returns. “If you shut down the practice in 2023, you will still have to file a tax return for that year in 2024,” he said.

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

Whether you’ve decided to retire, relocate, or work for your local hospital, unwinding your practice will take time. Physicians can avoid mistakes by planning ahead and making a checklist for what to do and when to do it.

“Doctors shouldn’t assume everything takes care of itself. Many don’t think about compliance issues, patient abandonment, or accounts receivable that they need to keep open to collect from billing, which can occur months after the dates of service,” said David Zetter, president of Zetter HealthCare management consultants in Pennsylvania.

Debra Phairas, president of Practice and Liability Consultants, LLC, in California, suggests doctors start planning for the closing of their practice at least 90-120 days from their closing date.

“Many people and entities need to be notified,” said Ms. Phairas. The list includes patients, payers, vendors, employees, licensing boards, and federal and state agencies.

Medical societies may have specific bylaws that apply; malpractice carriers have rules about how long you should retain medical records; and some state laws require that you communicate that you’re closing in a newspaper, Mr. Zetter added.

Ms. Phairas recommends that physicians decide first whether they will sell their practice or if they’ll just shut it down. If they sell and the buyer is a doctor, they may want to provide transition assistance such as introducing patients and staff, she said. Otherwise, doctors may need to terminate their staff.

After doctors make that decision, Mr. Zetter and Ms. Phairas recommend taking these 12 steps to ensure that the process goes smoothly.
 

What to do 60-90 days out

1. Check your insurance contracts. The Centers for Medicare & Medicaid Services requires physicians to notify them 90 days after deciding to retire or withdraw from Medicare or Medicaid. Other payers may also require 90 days’ notice to terminate their contracts.

You’ll also need to provide payers with a forwarding address for sending payments after the office closes, and notify your malpractice insurance carrier and any other contracted insurance carriers such as workers’ compensation or employee benefit plans.

2. Buy “tail” coverage. Doctors can be sued for malpractice years after they close their practice so this provides coverage against claims reported after the liability policy expires.

3. Check your hospital contracts. Most hospitals where you have privileges require 90 days’ notice that you are closing the practice.

4. Arrange for safe storage of medical records. If you are selling your practice to another physician, that doctor can take charge of them, as long as you obtain a patient’s consent to transfer the medical records, said Ms. Phairas. Otherwise, the practice is required to make someone the guardian of the records after the practice closes, said Mr. Zetter. This allows patients at a later date to obtain copies of their records at a cost.

“This usually means printing all the records to PDF to be retained; otherwise, doctors have to continue to pay the license fee for the EMR software to access the records, and no practice is going to continue to pay this indefinitely,” said Mr. Zetter.

Check with your malpractice insurance carrier for how long they require medical records to be retained, which may vary for adult and pediatric records.

Ms. Phairas also advises doctors to keep their original records. “The biggest mistake doctors can make is to give patients all their records. Your chart is your best defense weapon in a liability claim.”
 

What to do 30-60 days out

5. Tell your staff. They should not hear that you’re retiring or leaving the practice from other people, said Ms. Phairas. But timing is important. “If you notify them too soon, they may look for another job. I recommend telling them about 45 days out and just before you notify patients, although you may want to tell the office manager sooner.”

Doctors may need help closing the practice and should consider offering the employees a severance bonus to stay until the end, said Ms. Phairas. If they do leave sooner, then you can hire temporary staff.

6. Notify patients to avoid any claims of abandonment. You should notify all active patients, which, depending on your state, can be any patient the physician has treated sometime in the past 12-36 months.

Some state laws require the notice to be published as an advertisement in the local newspaper and will say how far in advance it needs to be published and how long the ad needs to run. Notification also should be posted throughout the practice, and patients who call or visit should be given oral reminders.

“Your biggest expense will be mailing a letter to all patients,” said Mr. Zetter. The letter should include:

• The date of closing.
• The name(s) of the physicians taking over the practice (if applicable).
• Local physicians who would be willing to accept new patients.
• Instructions for how patients can obtain or transfer medical records (with a deadline for submitting record requests).
• How to contact the practice if patients and families have any concerns about the closing.

7. Notify your professional associations. These include your state medical board, credentialing organizations, and professional memberships. It’s critical to renew your license even if you plan to practice in other states. He recalled that one doctor let his license lapse and the medical board notified Medicaid that he was no longer licensed. “CMS went after him because he didn’t notify them that he was no longer operating in Washington. CMS shut him down in every state/territory. This interventional radiologist spent 3 years with two attorneys to get it resolved,” said Mr. Zetter.

8. Terminate any leases with landlords or try to negotiate renting the office space on a month-to-month basis until you close or sell, suggests Ms. Phairas. If the practice owns the space, the partners will need to decide if the space will be sold or leased to a new business.
 

What to do 30 days out

9. Notify referring physicians of when you plan to close your practice so they don’t send new patients after that date.

10. Send a letter to the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.

11. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close out your accounts.

12. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.

Mr. Zetter also suggested retaining a certified accountant to handle the expenses for shutting down the business and to handle your future tax returns. “If you shut down the practice in 2023, you will still have to file a tax return for that year in 2024,” he said.

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

Whether you’ve decided to retire, relocate, or work for your local hospital, unwinding your practice will take time. Physicians can avoid mistakes by planning ahead and making a checklist for what to do and when to do it.

“Doctors shouldn’t assume everything takes care of itself. Many don’t think about compliance issues, patient abandonment, or accounts receivable that they need to keep open to collect from billing, which can occur months after the dates of service,” said David Zetter, president of Zetter HealthCare management consultants in Pennsylvania.

Debra Phairas, president of Practice and Liability Consultants, LLC, in California, suggests doctors start planning for the closing of their practice at least 90-120 days from their closing date.

“Many people and entities need to be notified,” said Ms. Phairas. The list includes patients, payers, vendors, employees, licensing boards, and federal and state agencies.

Medical societies may have specific bylaws that apply; malpractice carriers have rules about how long you should retain medical records; and some state laws require that you communicate that you’re closing in a newspaper, Mr. Zetter added.

Ms. Phairas recommends that physicians decide first whether they will sell their practice or if they’ll just shut it down. If they sell and the buyer is a doctor, they may want to provide transition assistance such as introducing patients and staff, she said. Otherwise, doctors may need to terminate their staff.

After doctors make that decision, Mr. Zetter and Ms. Phairas recommend taking these 12 steps to ensure that the process goes smoothly.
 

What to do 60-90 days out

1. Check your insurance contracts. The Centers for Medicare & Medicaid Services requires physicians to notify them 90 days after deciding to retire or withdraw from Medicare or Medicaid. Other payers may also require 90 days’ notice to terminate their contracts.

You’ll also need to provide payers with a forwarding address for sending payments after the office closes, and notify your malpractice insurance carrier and any other contracted insurance carriers such as workers’ compensation or employee benefit plans.

2. Buy “tail” coverage. Doctors can be sued for malpractice years after they close their practice so this provides coverage against claims reported after the liability policy expires.

3. Check your hospital contracts. Most hospitals where you have privileges require 90 days’ notice that you are closing the practice.

4. Arrange for safe storage of medical records. If you are selling your practice to another physician, that doctor can take charge of them, as long as you obtain a patient’s consent to transfer the medical records, said Ms. Phairas. Otherwise, the practice is required to make someone the guardian of the records after the practice closes, said Mr. Zetter. This allows patients at a later date to obtain copies of their records at a cost.

“This usually means printing all the records to PDF to be retained; otherwise, doctors have to continue to pay the license fee for the EMR software to access the records, and no practice is going to continue to pay this indefinitely,” said Mr. Zetter.

Check with your malpractice insurance carrier for how long they require medical records to be retained, which may vary for adult and pediatric records.

Ms. Phairas also advises doctors to keep their original records. “The biggest mistake doctors can make is to give patients all their records. Your chart is your best defense weapon in a liability claim.”
 

What to do 30-60 days out

5. Tell your staff. They should not hear that you’re retiring or leaving the practice from other people, said Ms. Phairas. But timing is important. “If you notify them too soon, they may look for another job. I recommend telling them about 45 days out and just before you notify patients, although you may want to tell the office manager sooner.”

Doctors may need help closing the practice and should consider offering the employees a severance bonus to stay until the end, said Ms. Phairas. If they do leave sooner, then you can hire temporary staff.

6. Notify patients to avoid any claims of abandonment. You should notify all active patients, which, depending on your state, can be any patient the physician has treated sometime in the past 12-36 months.

Some state laws require the notice to be published as an advertisement in the local newspaper and will say how far in advance it needs to be published and how long the ad needs to run. Notification also should be posted throughout the practice, and patients who call or visit should be given oral reminders.

“Your biggest expense will be mailing a letter to all patients,” said Mr. Zetter. The letter should include:

• The date of closing.
• The name(s) of the physicians taking over the practice (if applicable).
• Local physicians who would be willing to accept new patients.
• Instructions for how patients can obtain or transfer medical records (with a deadline for submitting record requests).
• How to contact the practice if patients and families have any concerns about the closing.

7. Notify your professional associations. These include your state medical board, credentialing organizations, and professional memberships. It’s critical to renew your license even if you plan to practice in other states. He recalled that one doctor let his license lapse and the medical board notified Medicaid that he was no longer licensed. “CMS went after him because he didn’t notify them that he was no longer operating in Washington. CMS shut him down in every state/territory. This interventional radiologist spent 3 years with two attorneys to get it resolved,” said Mr. Zetter.

8. Terminate any leases with landlords or try to negotiate renting the office space on a month-to-month basis until you close or sell, suggests Ms. Phairas. If the practice owns the space, the partners will need to decide if the space will be sold or leased to a new business.
 

What to do 30 days out

9. Notify referring physicians of when you plan to close your practice so they don’t send new patients after that date.

10. Send a letter to the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.

11. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close out your accounts.

12. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.

Mr. Zetter also suggested retaining a certified accountant to handle the expenses for shutting down the business and to handle your future tax returns. “If you shut down the practice in 2023, you will still have to file a tax return for that year in 2024,” he said.

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

Minimally invasive surfactant therapy (MIST) had mixed results in a 2-year follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome who were supported with continuous positive airway pressure (CPAP). Results of the OPTIMIST follow-up study were published online in JAMA.

Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age.

However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life.
 

Study spanned 11 countries

The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States.

It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.

The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.
 

No significant difference in deaths, NDD

Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24).

Secondary respiratory outcomes were better in the MIST group:

• Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81).
• Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90).
• Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively.
• Reported use of inhaled relievers (beta₂ agonists) was 23.9% in the MIST group versus 38.7% in controls.

The previous study of early outcomes of deaths or bronchopulmonary dysplasia (BPD; chronic lung injury in preterm infants) was published by the same group of researchers in 2021. 
 

Important benefit for respiratory health

Suhas G. Kallapur, MD, chief of the divisions of neonatology and developmental biology at University of California, Los Angeles, who was not part of either study, said: “This is one of the largest studies to date examining whether the MIST procedure for surfactant is beneficial in preterm babies born at 25-28 weeks’ gestation.”

Overall, when considering the 2021 and 2023 studies together, it appears that the MIST therapy has important benefits for respiratory health during a NICU stay and in early infancy, even though the primary outcome of death or NDD was not different between the treatment and control groups, Dr. Kallapur said.

“The slight (nonsignificant) increase in deaths in the MIST group was confined to the more immature babies – 25-26 weeks’ gestation at birth,” he pointed out. “In the bigger and more mature babies – 27-28 week gestation infants – the benefits of MIST therapy occurred without any increase in mortality, suggesting that this group of babies may be the group that stands to benefit most from this therapy.”

Dr. Kallapur said new data in the developmental origins of health and disease “now show that the trajectory of respiratory health in infancy is an important determinant of respiratory health into adulthood and older age.”

Therefore, the finding of benefit to respiratory health is particularly important, he said.

He noted that MIST or similar therapy is already in use in many NICUs throughout the world and that those already using it will likely feel vindicated by this study.

“Neonatologists who were on the sidelines will likely see these results – especially childhood respiratory outcomes – as a reason to initiate this procedure in all but the most immature preterm infants,” Dr. Kallapur says.

Dr. Dargaville reports personal fees from AbbVie and Chiesi Farmaceutici and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr. Dargaville has been issued a patent for a catheter design. One coauthor reports grants from Chiesi Farmaceutici during the conduct of the study. Another coauthor reports serving as chief investigator for OPTI-SURF, an observational study on United Kingdom neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. A third coauthor reports personal fees from Chiesi Farmaceutici outside the submitted work. This study was funded by grants from the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council. Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici. Dr. Kallapur has no relevant financial relationships.

Minimally invasive surfactant therapy (MIST) had mixed results in a 2-year follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome who were supported with continuous positive airway pressure (CPAP). Results of the OPTIMIST follow-up study were published online in JAMA.

Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age.

However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life.
 

Study spanned 11 countries

The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States.

It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.

The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.
 

No significant difference in deaths, NDD

Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24).

Secondary respiratory outcomes were better in the MIST group:

• Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81).
• Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90).
• Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively.
• Reported use of inhaled relievers (beta₂ agonists) was 23.9% in the MIST group versus 38.7% in controls.

The previous study of early outcomes of deaths or bronchopulmonary dysplasia (BPD; chronic lung injury in preterm infants) was published by the same group of researchers in 2021. 
 

Important benefit for respiratory health

Suhas G. Kallapur, MD, chief of the divisions of neonatology and developmental biology at University of California, Los Angeles, who was not part of either study, said: “This is one of the largest studies to date examining whether the MIST procedure for surfactant is beneficial in preterm babies born at 25-28 weeks’ gestation.”

Overall, when considering the 2021 and 2023 studies together, it appears that the MIST therapy has important benefits for respiratory health during a NICU stay and in early infancy, even though the primary outcome of death or NDD was not different between the treatment and control groups, Dr. Kallapur said.

“The slight (nonsignificant) increase in deaths in the MIST group was confined to the more immature babies – 25-26 weeks’ gestation at birth,” he pointed out. “In the bigger and more mature babies – 27-28 week gestation infants – the benefits of MIST therapy occurred without any increase in mortality, suggesting that this group of babies may be the group that stands to benefit most from this therapy.”

Dr. Kallapur said new data in the developmental origins of health and disease “now show that the trajectory of respiratory health in infancy is an important determinant of respiratory health into adulthood and older age.”

Therefore, the finding of benefit to respiratory health is particularly important, he said.

He noted that MIST or similar therapy is already in use in many NICUs throughout the world and that those already using it will likely feel vindicated by this study.

“Neonatologists who were on the sidelines will likely see these results – especially childhood respiratory outcomes – as a reason to initiate this procedure in all but the most immature preterm infants,” Dr. Kallapur says.

Dr. Dargaville reports personal fees from AbbVie and Chiesi Farmaceutici and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr. Dargaville has been issued a patent for a catheter design. One coauthor reports grants from Chiesi Farmaceutici during the conduct of the study. Another coauthor reports serving as chief investigator for OPTI-SURF, an observational study on United Kingdom neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. A third coauthor reports personal fees from Chiesi Farmaceutici outside the submitted work. This study was funded by grants from the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council. Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici. Dr. Kallapur has no relevant financial relationships.

Minimally invasive surfactant therapy (MIST) had mixed results in a 2-year follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome who were supported with continuous positive airway pressure (CPAP). Results of the OPTIMIST follow-up study were published online in JAMA.

Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age.

However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life.
 

Study spanned 11 countries

The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States.

It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.

The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.
 

No significant difference in deaths, NDD

Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24).

Secondary respiratory outcomes were better in the MIST group:

• Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81).
• Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90).
• Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively.
• Reported use of inhaled relievers (beta₂ agonists) was 23.9% in the MIST group versus 38.7% in controls.

The previous study of early outcomes of deaths or bronchopulmonary dysplasia (BPD; chronic lung injury in preterm infants) was published by the same group of researchers in 2021. 
 

Important benefit for respiratory health

Suhas G. Kallapur, MD, chief of the divisions of neonatology and developmental biology at University of California, Los Angeles, who was not part of either study, said: “This is one of the largest studies to date examining whether the MIST procedure for surfactant is beneficial in preterm babies born at 25-28 weeks’ gestation.”

Overall, when considering the 2021 and 2023 studies together, it appears that the MIST therapy has important benefits for respiratory health during a NICU stay and in early infancy, even though the primary outcome of death or NDD was not different between the treatment and control groups, Dr. Kallapur said.

“The slight (nonsignificant) increase in deaths in the MIST group was confined to the more immature babies – 25-26 weeks’ gestation at birth,” he pointed out. “In the bigger and more mature babies – 27-28 week gestation infants – the benefits of MIST therapy occurred without any increase in mortality, suggesting that this group of babies may be the group that stands to benefit most from this therapy.”

Dr. Kallapur said new data in the developmental origins of health and disease “now show that the trajectory of respiratory health in infancy is an important determinant of respiratory health into adulthood and older age.”

Therefore, the finding of benefit to respiratory health is particularly important, he said.

He noted that MIST or similar therapy is already in use in many NICUs throughout the world and that those already using it will likely feel vindicated by this study.

“Neonatologists who were on the sidelines will likely see these results – especially childhood respiratory outcomes – as a reason to initiate this procedure in all but the most immature preterm infants,” Dr. Kallapur says.

Dr. Dargaville reports personal fees from AbbVie and Chiesi Farmaceutici and provision of surfactant at reduced cost and support for conference travel from Chiesi Farmaceutici during the conduct of the study; in addition, Dr. Dargaville has been issued a patent for a catheter design. One coauthor reports grants from Chiesi Farmaceutici during the conduct of the study. Another coauthor reports serving as chief investigator for OPTI-SURF, an observational study on United Kingdom neonatal surfactant use in respiratory distress syndrome funded by Chiesi UK outside the submitted work. A third coauthor reports personal fees from Chiesi Farmaceutici outside the submitted work. This study was funded by grants from the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council. Exogenous surfactant was provided at reduced cost by Chiesi Farmaceutici. Dr. Kallapur has no relevant financial relationships.

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

A version of this article appeared on Medscape.com.

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

A version of this article appeared on Medscape.com.

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

A version of this article appeared on Medscape.com.

What happens to grief when those around you don’t understand it? Where does it go? How do you process it?

Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.

Here, we reflect as physicians on our own experiences and memories of this phenomenon.
 

Suzanne Cole, MD: ‘I didn’t feel the right to grieve’

During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.

Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.

But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.

To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
 

Don S. Dizon, MD: Working through tragedy

As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.

But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.

Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.

By the time help arrived, the patient was blue.

He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.

As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
 

A space for grieving: The Schwartz Center Rounds

Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.

Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.

More and more, though, we are being given opportunities to reflect on these sad moments.

The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.

During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.

As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.

Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.

Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.

As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.

We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.

Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.

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

What happens to grief when those around you don’t understand it? Where does it go? How do you process it?

Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.

Here, we reflect as physicians on our own experiences and memories of this phenomenon.
 

Suzanne Cole, MD: ‘I didn’t feel the right to grieve’

During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.

Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.

But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.

To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
 

Don S. Dizon, MD: Working through tragedy

As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.

But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.

Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.

By the time help arrived, the patient was blue.

He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.

As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
 

A space for grieving: The Schwartz Center Rounds

Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.

Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.

More and more, though, we are being given opportunities to reflect on these sad moments.

The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.

During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.

As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.

Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.

Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.

As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.

We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.

Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.

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

What happens to grief when those around you don’t understand it? Where does it go? How do you process it?

Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.

Here, we reflect as physicians on our own experiences and memories of this phenomenon.
 

Suzanne Cole, MD: ‘I didn’t feel the right to grieve’

During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.

Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.

But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.

To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
 

Don S. Dizon, MD: Working through tragedy

As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.

But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.

Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.

By the time help arrived, the patient was blue.

He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.

As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
 

A space for grieving: The Schwartz Center Rounds

Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.

Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.

More and more, though, we are being given opportunities to reflect on these sad moments.

The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.

During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.

As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.

Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.

Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.

As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.

We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.

Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.

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

The Diagnosis: Infantile Transient Smooth Muscle Contraction of the Skin

A diagnosis of infantile transient smooth muscle contraction of the skin (ITSMC) was made based on our patient’s clinical presentation and eliminating the diagnoses in the differential. No treatment ultimately was indicated, as episodes became less frequent over time.

The term infantile transient smooth muscle contraction of the skin was first proposed in 2013 by Torrelo et al,¹ who described 9 newborns with episodic skin rippling occasionally associated with exposure to cold or friction. The authors postulated that ITSMC was the result of a transient contraction of the arrector pili smooth muscle fibers of the skin, secondary to autonomic immaturity, primitive reflexes, or smooth muscle hypersensitivity.¹ Since this first description, ITSMC has remained a rarely reported and poorly understood phenomenon with rare identified cases in the literature.^2,3 Clinical history and examination of infants with intermittent transient skin rippling help to distinguish ITSMC from other diagnoses without the need for biopsy, which is particularly undesirable in the pediatric population.

Congenital smooth muscle hamartoma is a benign proliferation of mature smooth muscle that also can arise from the arrector pili muscles.⁴ In contrast to ITSMC, a hamartoma does not clear; rather, it persists and grows proportionally with the child and is associated with overlying hyperpigmentation and hypertrichosis. The transient nature of ITSMC may be worrisome for mastocytoma; however, this condition presents as erythematous, yellow, red, or brown macules, papules, plaques, or nodules with a positive Darier sign.⁵ Although the differential diagnosis includes the shagreen patch characteristic of tuberous sclerosis, this irregular plaque typically is located on the lower back with overlying peau d’orange skin changes, and our patient lacked other features indicative of this condition.⁶ Becker nevus also remains a consideration in patients with rippled skin, but this entity typically becomes more notable at puberty and is associated with hyperpigmentation and hypertrichosis and is a type of smooth muscle hamartoma.⁴

Our case highlighted the unusual presentation of ITSMC, a condition that can easily go unrecognized, leading to unnecessary referrals and concern. Familiarity with this benign diagnosis is essential to inform prognosis and guide management.

The Diagnosis: Infantile Transient Smooth Muscle Contraction of the Skin

A diagnosis of infantile transient smooth muscle contraction of the skin (ITSMC) was made based on our patient’s clinical presentation and eliminating the diagnoses in the differential. No treatment ultimately was indicated, as episodes became less frequent over time.

The term infantile transient smooth muscle contraction of the skin was first proposed in 2013 by Torrelo et al,¹ who described 9 newborns with episodic skin rippling occasionally associated with exposure to cold or friction. The authors postulated that ITSMC was the result of a transient contraction of the arrector pili smooth muscle fibers of the skin, secondary to autonomic immaturity, primitive reflexes, or smooth muscle hypersensitivity.¹ Since this first description, ITSMC has remained a rarely reported and poorly understood phenomenon with rare identified cases in the literature.^2,3 Clinical history and examination of infants with intermittent transient skin rippling help to distinguish ITSMC from other diagnoses without the need for biopsy, which is particularly undesirable in the pediatric population.

Congenital smooth muscle hamartoma is a benign proliferation of mature smooth muscle that also can arise from the arrector pili muscles.⁴ In contrast to ITSMC, a hamartoma does not clear; rather, it persists and grows proportionally with the child and is associated with overlying hyperpigmentation and hypertrichosis. The transient nature of ITSMC may be worrisome for mastocytoma; however, this condition presents as erythematous, yellow, red, or brown macules, papules, plaques, or nodules with a positive Darier sign.⁵ Although the differential diagnosis includes the shagreen patch characteristic of tuberous sclerosis, this irregular plaque typically is located on the lower back with overlying peau d’orange skin changes, and our patient lacked other features indicative of this condition.⁶ Becker nevus also remains a consideration in patients with rippled skin, but this entity typically becomes more notable at puberty and is associated with hyperpigmentation and hypertrichosis and is a type of smooth muscle hamartoma.⁴

Our case highlighted the unusual presentation of ITSMC, a condition that can easily go unrecognized, leading to unnecessary referrals and concern. Familiarity with this benign diagnosis is essential to inform prognosis and guide management.

The Diagnosis: Infantile Transient Smooth Muscle Contraction of the Skin

A diagnosis of infantile transient smooth muscle contraction of the skin (ITSMC) was made based on our patient’s clinical presentation and eliminating the diagnoses in the differential. No treatment ultimately was indicated, as episodes became less frequent over time.

The term infantile transient smooth muscle contraction of the skin was first proposed in 2013 by Torrelo et al,¹ who described 9 newborns with episodic skin rippling occasionally associated with exposure to cold or friction. The authors postulated that ITSMC was the result of a transient contraction of the arrector pili smooth muscle fibers of the skin, secondary to autonomic immaturity, primitive reflexes, or smooth muscle hypersensitivity.¹ Since this first description, ITSMC has remained a rarely reported and poorly understood phenomenon with rare identified cases in the literature.^2,3 Clinical history and examination of infants with intermittent transient skin rippling help to distinguish ITSMC from other diagnoses without the need for biopsy, which is particularly undesirable in the pediatric population.

Congenital smooth muscle hamartoma is a benign proliferation of mature smooth muscle that also can arise from the arrector pili muscles.⁴ In contrast to ITSMC, a hamartoma does not clear; rather, it persists and grows proportionally with the child and is associated with overlying hyperpigmentation and hypertrichosis. The transient nature of ITSMC may be worrisome for mastocytoma; however, this condition presents as erythematous, yellow, red, or brown macules, papules, plaques, or nodules with a positive Darier sign.⁵ Although the differential diagnosis includes the shagreen patch characteristic of tuberous sclerosis, this irregular plaque typically is located on the lower back with overlying peau d’orange skin changes, and our patient lacked other features indicative of this condition.⁶ Becker nevus also remains a consideration in patients with rippled skin, but this entity typically becomes more notable at puberty and is associated with hyperpigmentation and hypertrichosis and is a type of smooth muscle hamartoma.⁴

Our case highlighted the unusual presentation of ITSMC, a condition that can easily go unrecognized, leading to unnecessary referrals and concern. Familiarity with this benign diagnosis is essential to inform prognosis and guide management.

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.

According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.

According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.

According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

A few months ago I wrote a column in which I reluctantly supported designating obesity as a disease. My rationale was that in the more than 50 years that I have been watching the ebb and flow of medicine in this country I have seen very little, if any, evidence of success in our attempts to prevent obesity. Given this abysmal track record, the pragmatic side of my brain says why not label it a disease and begin to focus on treatment. However, I closed the column urging that we not lose sight of our core values and completely abandon any attempts at prevention.

As the months have rolled by, I have become increasingly concerned that preventing obesity is slipping further down the slippery slope to oblivion, greased by the success of semaglutide and the prospect of similar drugs in the pipeline. Before turning in our credentials as card-carrying preventionists, we need to step back and take another look at how we approach obesity from the pediatric side.

The majority of Americans believe that obesity occurs when an individual consumes more calories than he or she burns by being active. Some nutritionists criticize this “energy balance” model view as too simplistic and prefer a carbohydrate insulin model, which considers obesity as a metabolic disorder that is better managed by adjusting what the individual eats with less focus on amounts and the role of exercise. However, while the public may acknowledge that there are some individuals to whom genetics has dealt a more difficult hand, it continues to put a high priority on the dual roles of willpower and exercise. As effective obesity drugs become more available and remain safe, it is likely that willpower will no longer dominate the populous psyche.

But, what about children? At what point, if ever, does willpower enter the obesity discussion? A child may be able to exert some control over his or her diet by eating selectively. But, until the child acquires a certain level of resources and maturity it is parents who should be dictating the volume and variety of available food from which the child can choose. And, on the other side of the energy equation, parents should be playing a significant role in how much or how little physical activity their children engage in.

Of course there are many children whose genes predispose them to obesity when food is cheap and abundant. And, there are numerous families for whom socioeconomic factors limit their ability to control their children’s diet and activity options. However, we mustn’t lose sight of the fact that the majority of families may be making choices for their children that are contributing to the obesity problem in this country.

For example, a recent study published in Pediatrics has found that mean television viewing time during childhood and adolescence was associated with metabolic syndrome at age 45. Is this a failure on our part to anticipate this finding when for decades we as physicians have already seen anecdotal evidence to support it? Or is this another example of a willpower deficit by parents who likewise must have had an inkling that sitting on the couch watching television wasn’t healthy for their children?

Or is this just more evidence that as a nation we lack the political will to enact laws and develop programs aimed at heading off obesity in early childhood before it reaches the point that we have learned, from sad experience, is beyond the reach of dietary change, increased physical activity, and the fragility of normal human willpower. Here I’m talking about the disappearance of meaningful physical education in the schools, the failure to effectively prevent the marketing of poor nutritional foods and beverages to children, and the failure to aggressively promote universal breastfeeding-friendly workplaces and schedules, to name just a few.

As individuals we know all too well the limits of our own willpower. But, collectively as a nation we should be able to pool those fragmentary resources into a force for positive change. We may have thrown in the towel when we have opted to treat obesity as a disease in adults. Let’s find the will to work on prevention in early childhood when the window for change is still open.
 

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

A few months ago I wrote a column in which I reluctantly supported designating obesity as a disease. My rationale was that in the more than 50 years that I have been watching the ebb and flow of medicine in this country I have seen very little, if any, evidence of success in our attempts to prevent obesity. Given this abysmal track record, the pragmatic side of my brain says why not label it a disease and begin to focus on treatment. However, I closed the column urging that we not lose sight of our core values and completely abandon any attempts at prevention.

As the months have rolled by, I have become increasingly concerned that preventing obesity is slipping further down the slippery slope to oblivion, greased by the success of semaglutide and the prospect of similar drugs in the pipeline. Before turning in our credentials as card-carrying preventionists, we need to step back and take another look at how we approach obesity from the pediatric side.

The majority of Americans believe that obesity occurs when an individual consumes more calories than he or she burns by being active. Some nutritionists criticize this “energy balance” model view as too simplistic and prefer a carbohydrate insulin model, which considers obesity as a metabolic disorder that is better managed by adjusting what the individual eats with less focus on amounts and the role of exercise. However, while the public may acknowledge that there are some individuals to whom genetics has dealt a more difficult hand, it continues to put a high priority on the dual roles of willpower and exercise. As effective obesity drugs become more available and remain safe, it is likely that willpower will no longer dominate the populous psyche.

But, what about children? At what point, if ever, does willpower enter the obesity discussion? A child may be able to exert some control over his or her diet by eating selectively. But, until the child acquires a certain level of resources and maturity it is parents who should be dictating the volume and variety of available food from which the child can choose. And, on the other side of the energy equation, parents should be playing a significant role in how much or how little physical activity their children engage in.

Of course there are many children whose genes predispose them to obesity when food is cheap and abundant. And, there are numerous families for whom socioeconomic factors limit their ability to control their children’s diet and activity options. However, we mustn’t lose sight of the fact that the majority of families may be making choices for their children that are contributing to the obesity problem in this country.

For example, a recent study published in Pediatrics has found that mean television viewing time during childhood and adolescence was associated with metabolic syndrome at age 45. Is this a failure on our part to anticipate this finding when for decades we as physicians have already seen anecdotal evidence to support it? Or is this another example of a willpower deficit by parents who likewise must have had an inkling that sitting on the couch watching television wasn’t healthy for their children?

Or is this just more evidence that as a nation we lack the political will to enact laws and develop programs aimed at heading off obesity in early childhood before it reaches the point that we have learned, from sad experience, is beyond the reach of dietary change, increased physical activity, and the fragility of normal human willpower. Here I’m talking about the disappearance of meaningful physical education in the schools, the failure to effectively prevent the marketing of poor nutritional foods and beverages to children, and the failure to aggressively promote universal breastfeeding-friendly workplaces and schedules, to name just a few.

As individuals we know all too well the limits of our own willpower. But, collectively as a nation we should be able to pool those fragmentary resources into a force for positive change. We may have thrown in the towel when we have opted to treat obesity as a disease in adults. Let’s find the will to work on prevention in early childhood when the window for change is still open.
 

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

A few months ago I wrote a column in which I reluctantly supported designating obesity as a disease. My rationale was that in the more than 50 years that I have been watching the ebb and flow of medicine in this country I have seen very little, if any, evidence of success in our attempts to prevent obesity. Given this abysmal track record, the pragmatic side of my brain says why not label it a disease and begin to focus on treatment. However, I closed the column urging that we not lose sight of our core values and completely abandon any attempts at prevention.

As the months have rolled by, I have become increasingly concerned that preventing obesity is slipping further down the slippery slope to oblivion, greased by the success of semaglutide and the prospect of similar drugs in the pipeline. Before turning in our credentials as card-carrying preventionists, we need to step back and take another look at how we approach obesity from the pediatric side.

The majority of Americans believe that obesity occurs when an individual consumes more calories than he or she burns by being active. Some nutritionists criticize this “energy balance” model view as too simplistic and prefer a carbohydrate insulin model, which considers obesity as a metabolic disorder that is better managed by adjusting what the individual eats with less focus on amounts and the role of exercise. However, while the public may acknowledge that there are some individuals to whom genetics has dealt a more difficult hand, it continues to put a high priority on the dual roles of willpower and exercise. As effective obesity drugs become more available and remain safe, it is likely that willpower will no longer dominate the populous psyche.

But, what about children? At what point, if ever, does willpower enter the obesity discussion? A child may be able to exert some control over his or her diet by eating selectively. But, until the child acquires a certain level of resources and maturity it is parents who should be dictating the volume and variety of available food from which the child can choose. And, on the other side of the energy equation, parents should be playing a significant role in how much or how little physical activity their children engage in.

Of course there are many children whose genes predispose them to obesity when food is cheap and abundant. And, there are numerous families for whom socioeconomic factors limit their ability to control their children’s diet and activity options. However, we mustn’t lose sight of the fact that the majority of families may be making choices for their children that are contributing to the obesity problem in this country.

For example, a recent study published in Pediatrics has found that mean television viewing time during childhood and adolescence was associated with metabolic syndrome at age 45. Is this a failure on our part to anticipate this finding when for decades we as physicians have already seen anecdotal evidence to support it? Or is this another example of a willpower deficit by parents who likewise must have had an inkling that sitting on the couch watching television wasn’t healthy for their children?

Or is this just more evidence that as a nation we lack the political will to enact laws and develop programs aimed at heading off obesity in early childhood before it reaches the point that we have learned, from sad experience, is beyond the reach of dietary change, increased physical activity, and the fragility of normal human willpower. Here I’m talking about the disappearance of meaningful physical education in the schools, the failure to effectively prevent the marketing of poor nutritional foods and beverages to children, and the failure to aggressively promote universal breastfeeding-friendly workplaces and schedules, to name just a few.

As individuals we know all too well the limits of our own willpower. But, collectively as a nation we should be able to pool those fragmentary resources into a force for positive change. We may have thrown in the towel when we have opted to treat obesity as a disease in adults. Let’s find the will to work on prevention in early childhood when the window for change is still open.
 

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

By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.

Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.

There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.

Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.

Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.

“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.

He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.

“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”

The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.

Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
 

A plea for help

In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”

Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.

But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.

Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.

After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.

Five days later, his job offer was revoked.

In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.

The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”

Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.

“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.

Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.

“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”

“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.

Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.” 

Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
 

Current state of physician burnout

The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).

A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.

Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.

“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.

Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.

Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.

“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
 

Helping doctors regain a sense of purpose

One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose. 

“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”

Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.

“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
 

The road ahead

Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.

The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes. 

“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.

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

By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.

Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.

There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.

Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.

Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.

“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.

He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.

“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”

The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.

Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
 

A plea for help

In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”

Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.

But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.

Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.

After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.

Five days later, his job offer was revoked.

In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.

The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”

Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.

“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.

Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.

“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”

“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.

Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.” 

Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
 

Current state of physician burnout

The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).

A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.

Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.

“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.

Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.

Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.

“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
 

Helping doctors regain a sense of purpose

One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose. 

“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”

Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.

“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
 

The road ahead

Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.

The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes. 

“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.

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

By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.

Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.

There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.

Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.

Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.

“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.

He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.

“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”

The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.

Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
 

A plea for help

In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”

Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.

But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.

Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.

After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.

Five days later, his job offer was revoked.

In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.

The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”

Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.

“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.

Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.

“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”

“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.

Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.” 

Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
 

Current state of physician burnout

The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).

A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.

Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.

“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.

Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.

Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.

“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
 

Helping doctors regain a sense of purpose

One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose. 

“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”

Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.

“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
 

The road ahead

Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.

The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes. 

“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.

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