News from the FDA/CDC

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

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

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

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

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

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

Physicians nationwide will be challenged by the “unwinding” of the federal public health emergency declared for the COVID-19 pandemic.

The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.

A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.

The result is a patchwork of emergency COVID-19 measures with different end dates.

The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.

Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.

The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”

The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
 

Patients’ questions

Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).

“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”

Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.

For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.

The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.

“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.

States significantly changed Medicaid policy to expand access to care during the pandemic.

All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.

The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.

In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
 

The end of free COVID vaccines, testing for some patients

The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.

After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.

But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).

People who don’t have insurance may lose access to COVID testing and vaccines.

“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
 

Future FDA actions

Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.

But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.

The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.

The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.

The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.

“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.

Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.

“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”

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

Physicians nationwide will be challenged by the “unwinding” of the federal public health emergency declared for the COVID-19 pandemic.

The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.

A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.

The result is a patchwork of emergency COVID-19 measures with different end dates.

The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.

Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.

The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”

The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
 

Patients’ questions

Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).

“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”

Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.

For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.

The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.

“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.

States significantly changed Medicaid policy to expand access to care during the pandemic.

All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.

The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.

In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
 

The end of free COVID vaccines, testing for some patients

The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.

After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.

But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).

People who don’t have insurance may lose access to COVID testing and vaccines.

“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
 

Future FDA actions

Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.

But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.

The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.

The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.

The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.

“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.

Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.

“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”

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

Physicians nationwide will be challenged by the “unwinding” of the federal public health emergency declared for the COVID-19 pandemic.

The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.

A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.

The result is a patchwork of emergency COVID-19 measures with different end dates.

The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.

Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.

The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”

The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
 

Patients’ questions

Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).

“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”

Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.

For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.

The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.

“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.

States significantly changed Medicaid policy to expand access to care during the pandemic.

All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.

The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.

In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
 

The end of free COVID vaccines, testing for some patients

The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.

After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.

But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).

People who don’t have insurance may lose access to COVID testing and vaccines.

“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
 

Future FDA actions

Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.

But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.

The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.

The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.

The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.

“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.

Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.

“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”

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

The rising national suicide rate is being driven by increases among younger people and among people of color, according to a new report. 

Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.

In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.

Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.

“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.

The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.

CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic. 

From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.

“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.

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

The rising national suicide rate is being driven by increases among younger people and among people of color, according to a new report. 

Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.

In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.

Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.

“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.

The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.

CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic. 

From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.

“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.

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

The rising national suicide rate is being driven by increases among younger people and among people of color, according to a new report. 

Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.

In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.

Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.

“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.

The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.

CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic. 

From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.

“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.

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

A new vibrating pill shown to help relieve constipation is now available. 

The drug-free solution is designed for daily use. In a trial, the pill produced at least one additional weekly bowel movement for 41% of participants, compared with at least one additional bowel movement for 23% of participants who took a placebo pill. 

Vibrant was approved by the Food and Drug Administration in August but is just now becoming available for doctors to prescribe, the company announced Wednesday. 

Because it is not a drug, Vibrant is considered a class 2 medical device by the FDA, which is the same class as contact lenses.

Here’s how it works: Around bedtime, the pill is inserted in a pod to activate it, then swallowed. It travels the digestive tract and reaches the large intestine about 14 hours later. 

“Then it goes to work,” the company explained in a news release. “After it’s swallowed, it is active for about 2 hours, goes quiet for around 6, hours and then activates again for another 2 hours.”

“There are little vibrations for 3 seconds on, 3 seconds off,” said Cathy Collis, chief commercial officer for Israel-based Vibrant Gastro, in a statement.

The vibrations help trigger peristalsis, the wave-like muscle contractions that move food through the gastrointestinal tract, the company said. Decreased peristalsis is a cause of constipation, which is defined as having less than three bowel movements per week, according to the Cleveland Clinic. 

About 2.5 million people see their doctor each year for constipation. The pills are made of what the company called “medical-grade material” that is the same as what’s used to make gastroenterology cameras.

In the trial, most people did not report feeling the pill inside of them.

“A minority could feel it,” said Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a statement. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Dr. Quigley helped test the capsules and does not have a financial stake in the company, according to Vibrant.

The pills do not dissolve inside a person’s body. Rather, “after they’ve done their job, the person’s body poops them out, and they’re flushed away,” the company said.  

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

A new vibrating pill shown to help relieve constipation is now available. 

The drug-free solution is designed for daily use. In a trial, the pill produced at least one additional weekly bowel movement for 41% of participants, compared with at least one additional bowel movement for 23% of participants who took a placebo pill. 

Vibrant was approved by the Food and Drug Administration in August but is just now becoming available for doctors to prescribe, the company announced Wednesday. 

Because it is not a drug, Vibrant is considered a class 2 medical device by the FDA, which is the same class as contact lenses.

Here’s how it works: Around bedtime, the pill is inserted in a pod to activate it, then swallowed. It travels the digestive tract and reaches the large intestine about 14 hours later. 

“Then it goes to work,” the company explained in a news release. “After it’s swallowed, it is active for about 2 hours, goes quiet for around 6, hours and then activates again for another 2 hours.”

“There are little vibrations for 3 seconds on, 3 seconds off,” said Cathy Collis, chief commercial officer for Israel-based Vibrant Gastro, in a statement.

The vibrations help trigger peristalsis, the wave-like muscle contractions that move food through the gastrointestinal tract, the company said. Decreased peristalsis is a cause of constipation, which is defined as having less than three bowel movements per week, according to the Cleveland Clinic. 

About 2.5 million people see their doctor each year for constipation. The pills are made of what the company called “medical-grade material” that is the same as what’s used to make gastroenterology cameras.

In the trial, most people did not report feeling the pill inside of them.

“A minority could feel it,” said Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a statement. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Dr. Quigley helped test the capsules and does not have a financial stake in the company, according to Vibrant.

The pills do not dissolve inside a person’s body. Rather, “after they’ve done their job, the person’s body poops them out, and they’re flushed away,” the company said.  

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

A new vibrating pill shown to help relieve constipation is now available. 

The drug-free solution is designed for daily use. In a trial, the pill produced at least one additional weekly bowel movement for 41% of participants, compared with at least one additional bowel movement for 23% of participants who took a placebo pill. 

Vibrant was approved by the Food and Drug Administration in August but is just now becoming available for doctors to prescribe, the company announced Wednesday. 

Because it is not a drug, Vibrant is considered a class 2 medical device by the FDA, which is the same class as contact lenses.

Here’s how it works: Around bedtime, the pill is inserted in a pod to activate it, then swallowed. It travels the digestive tract and reaches the large intestine about 14 hours later. 

“Then it goes to work,” the company explained in a news release. “After it’s swallowed, it is active for about 2 hours, goes quiet for around 6, hours and then activates again for another 2 hours.”

“There are little vibrations for 3 seconds on, 3 seconds off,” said Cathy Collis, chief commercial officer for Israel-based Vibrant Gastro, in a statement.

The vibrations help trigger peristalsis, the wave-like muscle contractions that move food through the gastrointestinal tract, the company said. Decreased peristalsis is a cause of constipation, which is defined as having less than three bowel movements per week, according to the Cleveland Clinic. 

About 2.5 million people see their doctor each year for constipation. The pills are made of what the company called “medical-grade material” that is the same as what’s used to make gastroenterology cameras.

In the trial, most people did not report feeling the pill inside of them.

“A minority could feel it,” said Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a statement. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Dr. Quigley helped test the capsules and does not have a financial stake in the company, according to Vibrant.

The pills do not dissolve inside a person’s body. Rather, “after they’ve done their job, the person’s body poops them out, and they’re flushed away,” the company said.  

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

Among pediatric patients with psoriasis who began treatment with ustekinumab, etanercept, or methotrexate, the rate of serious infections at 6 months was low, with an incidence ranging between 14.9 and 25.6 per 1,000 person-years.

Those are key findings from what is believed to be the largest cohort study of its kind to estimate the 6-month rate of infections among children with psoriasis who started treatment with ustekinumab, etanercept, or methotrexate.

“Clinical trials have demonstrated high efficacy of new immunomodulatory agents in treating children with psoriasis,” lead author Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the departments of medicine and dermatology at Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues wrote in the article, which was published online in JAMA Dermatology. “However, the risk of infections in clinical practice has not been fully characterized by comparing these medications against each other in pairwise comparisons.”

Drawing from two large U.S. insurance claims databases, the researchers identified 2,338 patients aged 17 years and younger who were receiving treatment with a topical medication for psoriasis and started new treatment with ustekinumab, etanercept, or methotrexate. They stratified their analysis by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021), and their follow-up of patients started 1 day after initiating treatment and ended at 6 months.

Of the 2,338 patients, 1,368 (58%) were girls. From 2009 through 2021, 379 patients began treatment with ustekinumab, 779 patients began treatment with etanercept, and 1,180 patients began treatment with methotrexate. The propensity score–adjusted incidence rate of serious infection was 18.4 per 1,000 person-years (3 events) for those who used ustekinumab, 25.6 per 1,000 person-years (9 events) for those who used etanercept, and 14.9 per 1,000 person-years (8 events) for those who used methotrexate. The adjusted rate of outpatient infections was 254.9 per 1,000 person-years (39 events) for those who used ustekinumab, 435.7 per 1,000 person-years (139 events) for those who used etanercept, and 433.6 per 1,000 person-years (209 events) for those who used methotrexate. Meanwhile, the adjusted rate ratio of outpatient infections was 0.58 for ustekinumab vs. etanercept, 0.66 for ustekinumab vs. methotrexate, and 0.95 for etanercept vs. methotrexate. The researchers found that ratios were similar during the off-label use era and after pediatric labeling.

Anna L. Grossberg, MD, director of pediatric dermatology at the Johns Hopkins Children’s Center, Baltimore, who was asked to comment on the work, told this news organization that the data on outpatient infections in ustekinumab users “demonstrated that they may have a decreased risk of infection compared to pediatric psoriasis patients treated with methotrexate or the TNF-alpha inhibitor etanercept. This is previously unreported and reflects my personal experience with this medication in my own pediatric psoriasis patients.” She added the study’s overall findings lend further support to the safety of biologic medications and nonbiologic systemic immunomodulatory treatments for management of psoriasis. “This study will help guide pediatric dermatologists in counseling patients and their families about these risks [of infection], and in general providing reassurance that these risks appear to be quite low,” Dr. Grossberg said. “In particular, ustekinumab, a newer biologic medication that was recently FDA-approved for children 6 years and older for pediatric psoriasis, was not associated with higher infection rates than the other agents analyzed in this study, and in fact appears to carry a reduced risk compared to both etanercept and methotrexate.”

She noted certain limitations of the study, including its reliance on insurance claims data, “which can be limiting because information on possible confounding variables may not be known,” she said. “For example, the authors point out that environmental and behavioral risk factors for serious infection could not be evaluated or adjusted for, nor could the severity of the patients’ psoriasis. Additionally, this study only reported on outpatient infections that resulted in an antibiotic or other medications being prescribed and filled. It therefore may have missed children who presented with certain viral infections (examples could include the common cold and uncomplicated ear infections), which often will not require a prescription medication. Furthermore, it would fail to capture those who may have been seen for an infection but failed to fill the intended prescription.”

Dr. Schneeweiss reported receiving grants from AbbVie and UCB to Brigham and Women’s Hospital unrelated to the topic of this study and outside the submitted work. The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Grossberg reported having no financial disclosures.

Among pediatric patients with psoriasis who began treatment with ustekinumab, etanercept, or methotrexate, the rate of serious infections at 6 months was low, with an incidence ranging between 14.9 and 25.6 per 1,000 person-years.

Those are key findings from what is believed to be the largest cohort study of its kind to estimate the 6-month rate of infections among children with psoriasis who started treatment with ustekinumab, etanercept, or methotrexate.

“Clinical trials have demonstrated high efficacy of new immunomodulatory agents in treating children with psoriasis,” lead author Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the departments of medicine and dermatology at Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues wrote in the article, which was published online in JAMA Dermatology. “However, the risk of infections in clinical practice has not been fully characterized by comparing these medications against each other in pairwise comparisons.”

Drawing from two large U.S. insurance claims databases, the researchers identified 2,338 patients aged 17 years and younger who were receiving treatment with a topical medication for psoriasis and started new treatment with ustekinumab, etanercept, or methotrexate. They stratified their analysis by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021), and their follow-up of patients started 1 day after initiating treatment and ended at 6 months.

Of the 2,338 patients, 1,368 (58%) were girls. From 2009 through 2021, 379 patients began treatment with ustekinumab, 779 patients began treatment with etanercept, and 1,180 patients began treatment with methotrexate. The propensity score–adjusted incidence rate of serious infection was 18.4 per 1,000 person-years (3 events) for those who used ustekinumab, 25.6 per 1,000 person-years (9 events) for those who used etanercept, and 14.9 per 1,000 person-years (8 events) for those who used methotrexate. The adjusted rate of outpatient infections was 254.9 per 1,000 person-years (39 events) for those who used ustekinumab, 435.7 per 1,000 person-years (139 events) for those who used etanercept, and 433.6 per 1,000 person-years (209 events) for those who used methotrexate. Meanwhile, the adjusted rate ratio of outpatient infections was 0.58 for ustekinumab vs. etanercept, 0.66 for ustekinumab vs. methotrexate, and 0.95 for etanercept vs. methotrexate. The researchers found that ratios were similar during the off-label use era and after pediatric labeling.

Anna L. Grossberg, MD, director of pediatric dermatology at the Johns Hopkins Children’s Center, Baltimore, who was asked to comment on the work, told this news organization that the data on outpatient infections in ustekinumab users “demonstrated that they may have a decreased risk of infection compared to pediatric psoriasis patients treated with methotrexate or the TNF-alpha inhibitor etanercept. This is previously unreported and reflects my personal experience with this medication in my own pediatric psoriasis patients.” She added the study’s overall findings lend further support to the safety of biologic medications and nonbiologic systemic immunomodulatory treatments for management of psoriasis. “This study will help guide pediatric dermatologists in counseling patients and their families about these risks [of infection], and in general providing reassurance that these risks appear to be quite low,” Dr. Grossberg said. “In particular, ustekinumab, a newer biologic medication that was recently FDA-approved for children 6 years and older for pediatric psoriasis, was not associated with higher infection rates than the other agents analyzed in this study, and in fact appears to carry a reduced risk compared to both etanercept and methotrexate.”

She noted certain limitations of the study, including its reliance on insurance claims data, “which can be limiting because information on possible confounding variables may not be known,” she said. “For example, the authors point out that environmental and behavioral risk factors for serious infection could not be evaluated or adjusted for, nor could the severity of the patients’ psoriasis. Additionally, this study only reported on outpatient infections that resulted in an antibiotic or other medications being prescribed and filled. It therefore may have missed children who presented with certain viral infections (examples could include the common cold and uncomplicated ear infections), which often will not require a prescription medication. Furthermore, it would fail to capture those who may have been seen for an infection but failed to fill the intended prescription.”

Dr. Schneeweiss reported receiving grants from AbbVie and UCB to Brigham and Women’s Hospital unrelated to the topic of this study and outside the submitted work. The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Grossberg reported having no financial disclosures.

Among pediatric patients with psoriasis who began treatment with ustekinumab, etanercept, or methotrexate, the rate of serious infections at 6 months was low, with an incidence ranging between 14.9 and 25.6 per 1,000 person-years.

Those are key findings from what is believed to be the largest cohort study of its kind to estimate the 6-month rate of infections among children with psoriasis who started treatment with ustekinumab, etanercept, or methotrexate.

“Clinical trials have demonstrated high efficacy of new immunomodulatory agents in treating children with psoriasis,” lead author Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the departments of medicine and dermatology at Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues wrote in the article, which was published online in JAMA Dermatology. “However, the risk of infections in clinical practice has not been fully characterized by comparing these medications against each other in pairwise comparisons.”

Drawing from two large U.S. insurance claims databases, the researchers identified 2,338 patients aged 17 years and younger who were receiving treatment with a topical medication for psoriasis and started new treatment with ustekinumab, etanercept, or methotrexate. They stratified their analysis by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021), and their follow-up of patients started 1 day after initiating treatment and ended at 6 months.

Of the 2,338 patients, 1,368 (58%) were girls. From 2009 through 2021, 379 patients began treatment with ustekinumab, 779 patients began treatment with etanercept, and 1,180 patients began treatment with methotrexate. The propensity score–adjusted incidence rate of serious infection was 18.4 per 1,000 person-years (3 events) for those who used ustekinumab, 25.6 per 1,000 person-years (9 events) for those who used etanercept, and 14.9 per 1,000 person-years (8 events) for those who used methotrexate. The adjusted rate of outpatient infections was 254.9 per 1,000 person-years (39 events) for those who used ustekinumab, 435.7 per 1,000 person-years (139 events) for those who used etanercept, and 433.6 per 1,000 person-years (209 events) for those who used methotrexate. Meanwhile, the adjusted rate ratio of outpatient infections was 0.58 for ustekinumab vs. etanercept, 0.66 for ustekinumab vs. methotrexate, and 0.95 for etanercept vs. methotrexate. The researchers found that ratios were similar during the off-label use era and after pediatric labeling.

Anna L. Grossberg, MD, director of pediatric dermatology at the Johns Hopkins Children’s Center, Baltimore, who was asked to comment on the work, told this news organization that the data on outpatient infections in ustekinumab users “demonstrated that they may have a decreased risk of infection compared to pediatric psoriasis patients treated with methotrexate or the TNF-alpha inhibitor etanercept. This is previously unreported and reflects my personal experience with this medication in my own pediatric psoriasis patients.” She added the study’s overall findings lend further support to the safety of biologic medications and nonbiologic systemic immunomodulatory treatments for management of psoriasis. “This study will help guide pediatric dermatologists in counseling patients and their families about these risks [of infection], and in general providing reassurance that these risks appear to be quite low,” Dr. Grossberg said. “In particular, ustekinumab, a newer biologic medication that was recently FDA-approved for children 6 years and older for pediatric psoriasis, was not associated with higher infection rates than the other agents analyzed in this study, and in fact appears to carry a reduced risk compared to both etanercept and methotrexate.”

She noted certain limitations of the study, including its reliance on insurance claims data, “which can be limiting because information on possible confounding variables may not be known,” she said. “For example, the authors point out that environmental and behavioral risk factors for serious infection could not be evaluated or adjusted for, nor could the severity of the patients’ psoriasis. Additionally, this study only reported on outpatient infections that resulted in an antibiotic or other medications being prescribed and filled. It therefore may have missed children who presented with certain viral infections (examples could include the common cold and uncomplicated ear infections), which often will not require a prescription medication. Furthermore, it would fail to capture those who may have been seen for an infection but failed to fill the intended prescription.”

Dr. Schneeweiss reported receiving grants from AbbVie and UCB to Brigham and Women’s Hospital unrelated to the topic of this study and outside the submitted work. The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Grossberg reported having no financial disclosures.

The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2023.

In a policy statement published online in the journal Pediatrics, the AAP said the updated recommendations do not include major changes from those released in 2022 by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

In one small shift, COVID-19 is now addressed in the main text instead of being relegated to the notes section.

“And a new vaccine – Priorix [GlaxoSmithKline] – has been added for MMR [measles, mumps, rubella], so now there are two available,” Sean T. O’Leary, MD, MPH, chair of the AAP’s Committee on Infectious Diseases, told this news organization. “There’s also a second pneumococcal conjugate vaccine listed, PCV15, and this and PCV13 can essentially be used interchangeably.”

Minor updates to the schedule, reflected on the cover page, relate to vaccines for COVID-19, dengue fever, and pneumococcal disease, added Dr. O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora.

The committee also changed layouts to improve the usability of the schedule. Updated annually, the guidance provides a table on recommended pediatric immunizations from birth to age 18 years, and catch-up recommendations for children aged 4 months to 18 years who start their vaccinations late or are more than 1 month behind the recommended age for vaccine administration.

“We hope this annual update will encourage clinicians to make sure all their patients are up to date on their routine vaccinations,” Dr. O’Leary said. “It’s an opportunity to develop strategies to improve vaccination rates.”

The 2023 schedule follows news from the CDC that kindergarten vaccination rates declined during the 2021-2022 school year. Only 93% of kindergarteners obtained full vaccinations, representing a drop of 1 percentage point from the year before and 2 percentage points from the 2019-2020 school year.

The dip in coverage has been attributed to disruptions caused by the COVID-19 pandemic. AAP advises health care professionals to urge families to make sure their child’s vaccines are current.

Among other additions:
 

In Table 1

• MMR: Second vaccine added (Priorix, GlaxoSmithKline Biologicals)
• Pneumococcal disease: second conjugate vaccine, PCV15, added (Vaxneuvance, Merck Sharp & Dohme).
• COVID-19: New row added.
• Dengue: Text changed from “Seropositive in endemic areas only” to “Seropositive in endemic dengue areas.”
• Inactivated polio vaccine: “See Notes” added to the column for children aged 18 years.

In Table 2

• PCV: Dose 3 to dose 4 interval revised to align with ACIP’s recommendation for dose 4. This dose is necessary only for children ages 12-59 months regardless of risk, or age 60-71 months with any risk who received three doses before age 12 months.

A parent-friendly vaccine schedule for children and adolescents is available on the CDC’s website.

“Vaccines are essential for the health of our whole society, including children and adolescents,” Dr. O’Leary said in a press release from AAP. “These schedules provide a road map [that] parents and pediatricians can follow to help children get the vaccines they need so their immune systems will be ready to recognize and resist diseases.”

As previously, the 2023 schedule was adjusted to ensure consistency between the formats of the childhood/adolescent and adult immunization guidance. A meeting of stakeholder organizations in October 2022 harmonized the two formats.

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

The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2023.

In a policy statement published online in the journal Pediatrics, the AAP said the updated recommendations do not include major changes from those released in 2022 by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

In one small shift, COVID-19 is now addressed in the main text instead of being relegated to the notes section.

“And a new vaccine – Priorix [GlaxoSmithKline] – has been added for MMR [measles, mumps, rubella], so now there are two available,” Sean T. O’Leary, MD, MPH, chair of the AAP’s Committee on Infectious Diseases, told this news organization. “There’s also a second pneumococcal conjugate vaccine listed, PCV15, and this and PCV13 can essentially be used interchangeably.”

Minor updates to the schedule, reflected on the cover page, relate to vaccines for COVID-19, dengue fever, and pneumococcal disease, added Dr. O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora.

The committee also changed layouts to improve the usability of the schedule. Updated annually, the guidance provides a table on recommended pediatric immunizations from birth to age 18 years, and catch-up recommendations for children aged 4 months to 18 years who start their vaccinations late or are more than 1 month behind the recommended age for vaccine administration.

“We hope this annual update will encourage clinicians to make sure all their patients are up to date on their routine vaccinations,” Dr. O’Leary said. “It’s an opportunity to develop strategies to improve vaccination rates.”

The 2023 schedule follows news from the CDC that kindergarten vaccination rates declined during the 2021-2022 school year. Only 93% of kindergarteners obtained full vaccinations, representing a drop of 1 percentage point from the year before and 2 percentage points from the 2019-2020 school year.

The dip in coverage has been attributed to disruptions caused by the COVID-19 pandemic. AAP advises health care professionals to urge families to make sure their child’s vaccines are current.

Among other additions:
 

In Table 1

• MMR: Second vaccine added (Priorix, GlaxoSmithKline Biologicals)
• Pneumococcal disease: second conjugate vaccine, PCV15, added (Vaxneuvance, Merck Sharp & Dohme).
• COVID-19: New row added.
• Dengue: Text changed from “Seropositive in endemic areas only” to “Seropositive in endemic dengue areas.”
• Inactivated polio vaccine: “See Notes” added to the column for children aged 18 years.

In Table 2

• PCV: Dose 3 to dose 4 interval revised to align with ACIP’s recommendation for dose 4. This dose is necessary only for children ages 12-59 months regardless of risk, or age 60-71 months with any risk who received three doses before age 12 months.

A parent-friendly vaccine schedule for children and adolescents is available on the CDC’s website.

“Vaccines are essential for the health of our whole society, including children and adolescents,” Dr. O’Leary said in a press release from AAP. “These schedules provide a road map [that] parents and pediatricians can follow to help children get the vaccines they need so their immune systems will be ready to recognize and resist diseases.”

As previously, the 2023 schedule was adjusted to ensure consistency between the formats of the childhood/adolescent and adult immunization guidance. A meeting of stakeholder organizations in October 2022 harmonized the two formats.

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

The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2023.

In a policy statement published online in the journal Pediatrics, the AAP said the updated recommendations do not include major changes from those released in 2022 by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

In one small shift, COVID-19 is now addressed in the main text instead of being relegated to the notes section.

“And a new vaccine – Priorix [GlaxoSmithKline] – has been added for MMR [measles, mumps, rubella], so now there are two available,” Sean T. O’Leary, MD, MPH, chair of the AAP’s Committee on Infectious Diseases, told this news organization. “There’s also a second pneumococcal conjugate vaccine listed, PCV15, and this and PCV13 can essentially be used interchangeably.”

Minor updates to the schedule, reflected on the cover page, relate to vaccines for COVID-19, dengue fever, and pneumococcal disease, added Dr. O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora.

The committee also changed layouts to improve the usability of the schedule. Updated annually, the guidance provides a table on recommended pediatric immunizations from birth to age 18 years, and catch-up recommendations for children aged 4 months to 18 years who start their vaccinations late or are more than 1 month behind the recommended age for vaccine administration.

“We hope this annual update will encourage clinicians to make sure all their patients are up to date on their routine vaccinations,” Dr. O’Leary said. “It’s an opportunity to develop strategies to improve vaccination rates.”

The 2023 schedule follows news from the CDC that kindergarten vaccination rates declined during the 2021-2022 school year. Only 93% of kindergarteners obtained full vaccinations, representing a drop of 1 percentage point from the year before and 2 percentage points from the 2019-2020 school year.

The dip in coverage has been attributed to disruptions caused by the COVID-19 pandemic. AAP advises health care professionals to urge families to make sure their child’s vaccines are current.

Among other additions:
 

In Table 1

• MMR: Second vaccine added (Priorix, GlaxoSmithKline Biologicals)
• Pneumococcal disease: second conjugate vaccine, PCV15, added (Vaxneuvance, Merck Sharp & Dohme).
• COVID-19: New row added.
• Dengue: Text changed from “Seropositive in endemic areas only” to “Seropositive in endemic dengue areas.”
• Inactivated polio vaccine: “See Notes” added to the column for children aged 18 years.

In Table 2

• PCV: Dose 3 to dose 4 interval revised to align with ACIP’s recommendation for dose 4. This dose is necessary only for children ages 12-59 months regardless of risk, or age 60-71 months with any risk who received three doses before age 12 months.

A parent-friendly vaccine schedule for children and adolescents is available on the CDC’s website.

“Vaccines are essential for the health of our whole society, including children and adolescents,” Dr. O’Leary said in a press release from AAP. “These schedules provide a road map [that] parents and pediatricians can follow to help children get the vaccines they need so their immune systems will be ready to recognize and resist diseases.”

As previously, the 2023 schedule was adjusted to ensure consistency between the formats of the childhood/adolescent and adult immunization guidance. A meeting of stakeholder organizations in October 2022 harmonized the two formats.

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

The Food and Drug Administration approved a new indication for sacituzumab govitecan (Trodelvy, Gilead Sciences) on Feb. 3 for patients with unresectable, locally advanced or metastatic hormone receptor (HR)–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.

Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial, which randomized 543 adults 1:1 to either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle or single agent chemotherapy, most often eribulin but also vinorelbine, gemcitabine, or capecitabine.

Median progression free survival was 5.5 months with sacituzumab govitecan versus 4 months with single agent chemotherapy (hazard ratio, 0.66; P = .0003). Median overall survival was 14.4 months in the sacituzumab govitecan group versus 11.2 months with chemotherapy (HR, 0.79), according to an FDA press release announcing the approval.

In a Gilead press release, Hope Rugo, MD, a breast cancer specialist at the University of California, San Francisco, and principal investigator for TROPICS-02, said the approval “is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”

The most common adverse events associated with sacituzumab govitecan in the trial, occurring in a quarter or more of participants, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin.

Labeling for the agent carries a boxedwarning of severe or life-threatening neutropenia and severe diarrhea.

The recommended dose is the trial dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.

Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.

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

The Food and Drug Administration approved a new indication for sacituzumab govitecan (Trodelvy, Gilead Sciences) on Feb. 3 for patients with unresectable, locally advanced or metastatic hormone receptor (HR)–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.

Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial, which randomized 543 adults 1:1 to either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle or single agent chemotherapy, most often eribulin but also vinorelbine, gemcitabine, or capecitabine.

Median progression free survival was 5.5 months with sacituzumab govitecan versus 4 months with single agent chemotherapy (hazard ratio, 0.66; P = .0003). Median overall survival was 14.4 months in the sacituzumab govitecan group versus 11.2 months with chemotherapy (HR, 0.79), according to an FDA press release announcing the approval.

In a Gilead press release, Hope Rugo, MD, a breast cancer specialist at the University of California, San Francisco, and principal investigator for TROPICS-02, said the approval “is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”

The most common adverse events associated with sacituzumab govitecan in the trial, occurring in a quarter or more of participants, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin.

Labeling for the agent carries a boxedwarning of severe or life-threatening neutropenia and severe diarrhea.

The recommended dose is the trial dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.

Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.

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

The Food and Drug Administration approved a new indication for sacituzumab govitecan (Trodelvy, Gilead Sciences) on Feb. 3 for patients with unresectable, locally advanced or metastatic hormone receptor (HR)–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.

Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial, which randomized 543 adults 1:1 to either sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle or single agent chemotherapy, most often eribulin but also vinorelbine, gemcitabine, or capecitabine.

Median progression free survival was 5.5 months with sacituzumab govitecan versus 4 months with single agent chemotherapy (hazard ratio, 0.66; P = .0003). Median overall survival was 14.4 months in the sacituzumab govitecan group versus 11.2 months with chemotherapy (HR, 0.79), according to an FDA press release announcing the approval.

In a Gilead press release, Hope Rugo, MD, a breast cancer specialist at the University of California, San Francisco, and principal investigator for TROPICS-02, said the approval “is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”

The most common adverse events associated with sacituzumab govitecan in the trial, occurring in a quarter or more of participants, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin.

Labeling for the agent carries a boxedwarning of severe or life-threatening neutropenia and severe diarrhea.

The recommended dose is the trial dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.

Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.

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

The drug overdose death rate in the United States climbed 376% from 2001 to 2021, with much of that increase occurring in the last 2 years, according to the National Center for Heath Statistics.

The 376% represents the change in age-adjusted overdose deaths per 100,000 population, which went from 6.9 in 2001 to 32.4 in 2021, as the total number of deaths rose from 19,394 to 106,699 (450%) over that time period, the NCHS said in a recent data brief. That total made 2021 the first year ever with more than 100,000 overdose deaths.

Since the age-adjusted rate stood at 21.6 per 100,000 in 2019, that means 42% of the total increase over 20 years actually occurred in 2020 and 2021. The number of deaths increased by about 36,000 over those 2 years, accounting for 41% of the total annual increase from 2001 to 2021, based on data from the National Vital Statistics System mortality files.

The overdose death rate was significantly higher for males than females for all of the years from 2001 to 2021, with males seeing an increase from 9.0 to 45.1 per 100,000 and females going from 4.6 to 19.6 deaths per 100,000. In the single year from 2020 to 2021, the age-adjusted rate was up by 14% for males and 15% for females, the mortality-file data show.

Analysis by age showed an even larger effect in some groups from 2020 to 2021. Drug overdose deaths jumped 28% among adults aged 65 years and older, more than any other group, and by 21% in those aged 55-64 years, according to the NCHS.

The only age group for which deaths didn’t increase significantly from 2020 to 2021 was 15- to 24-year-olds, whose rate rose by just 3%. The age group with the highest rate in both 2020 and 2021, however, was the 35- to 44-year-olds: 53.9 and 62.0 overdose deaths per 100,000, respectively, for an increase of 15%, the NCHS said in the report.

The drugs now involved in overdose deaths are most often opioids, a change from 2001. That year, opioids were involved in 49% of all overdose deaths, but by 2021 that share had increased to 75%. The trend for opioid-related deaths almost matches that of overall deaths over the 20-year span, and the significantly increasing trend that began for all overdose deaths in 2013 closely follows that of synthetic opioids such as fentanyl and tramadol, the report shows.

Overdose deaths involving cocaine and psychostimulants such as methamphetamine, amphetamine, and methylphenidate also show similar increases. The cocaine-related death rate rose 22% from 2020 to 2021 and is up by 421% since 2012, while the corresponding increases for psychostimulant deaths were 33% and 2,400%, the NCHS said.

The drug overdose death rate in the United States climbed 376% from 2001 to 2021, with much of that increase occurring in the last 2 years, according to the National Center for Heath Statistics.

The 376% represents the change in age-adjusted overdose deaths per 100,000 population, which went from 6.9 in 2001 to 32.4 in 2021, as the total number of deaths rose from 19,394 to 106,699 (450%) over that time period, the NCHS said in a recent data brief. That total made 2021 the first year ever with more than 100,000 overdose deaths.

Since the age-adjusted rate stood at 21.6 per 100,000 in 2019, that means 42% of the total increase over 20 years actually occurred in 2020 and 2021. The number of deaths increased by about 36,000 over those 2 years, accounting for 41% of the total annual increase from 2001 to 2021, based on data from the National Vital Statistics System mortality files.

The overdose death rate was significantly higher for males than females for all of the years from 2001 to 2021, with males seeing an increase from 9.0 to 45.1 per 100,000 and females going from 4.6 to 19.6 deaths per 100,000. In the single year from 2020 to 2021, the age-adjusted rate was up by 14% for males and 15% for females, the mortality-file data show.

Analysis by age showed an even larger effect in some groups from 2020 to 2021. Drug overdose deaths jumped 28% among adults aged 65 years and older, more than any other group, and by 21% in those aged 55-64 years, according to the NCHS.

The only age group for which deaths didn’t increase significantly from 2020 to 2021 was 15- to 24-year-olds, whose rate rose by just 3%. The age group with the highest rate in both 2020 and 2021, however, was the 35- to 44-year-olds: 53.9 and 62.0 overdose deaths per 100,000, respectively, for an increase of 15%, the NCHS said in the report.

The drugs now involved in overdose deaths are most often opioids, a change from 2001. That year, opioids were involved in 49% of all overdose deaths, but by 2021 that share had increased to 75%. The trend for opioid-related deaths almost matches that of overall deaths over the 20-year span, and the significantly increasing trend that began for all overdose deaths in 2013 closely follows that of synthetic opioids such as fentanyl and tramadol, the report shows.

Overdose deaths involving cocaine and psychostimulants such as methamphetamine, amphetamine, and methylphenidate also show similar increases. The cocaine-related death rate rose 22% from 2020 to 2021 and is up by 421% since 2012, while the corresponding increases for psychostimulant deaths were 33% and 2,400%, the NCHS said.

The drug overdose death rate in the United States climbed 376% from 2001 to 2021, with much of that increase occurring in the last 2 years, according to the National Center for Heath Statistics.

The 376% represents the change in age-adjusted overdose deaths per 100,000 population, which went from 6.9 in 2001 to 32.4 in 2021, as the total number of deaths rose from 19,394 to 106,699 (450%) over that time period, the NCHS said in a recent data brief. That total made 2021 the first year ever with more than 100,000 overdose deaths.

Since the age-adjusted rate stood at 21.6 per 100,000 in 2019, that means 42% of the total increase over 20 years actually occurred in 2020 and 2021. The number of deaths increased by about 36,000 over those 2 years, accounting for 41% of the total annual increase from 2001 to 2021, based on data from the National Vital Statistics System mortality files.

The overdose death rate was significantly higher for males than females for all of the years from 2001 to 2021, with males seeing an increase from 9.0 to 45.1 per 100,000 and females going from 4.6 to 19.6 deaths per 100,000. In the single year from 2020 to 2021, the age-adjusted rate was up by 14% for males and 15% for females, the mortality-file data show.

Analysis by age showed an even larger effect in some groups from 2020 to 2021. Drug overdose deaths jumped 28% among adults aged 65 years and older, more than any other group, and by 21% in those aged 55-64 years, according to the NCHS.

The only age group for which deaths didn’t increase significantly from 2020 to 2021 was 15- to 24-year-olds, whose rate rose by just 3%. The age group with the highest rate in both 2020 and 2021, however, was the 35- to 44-year-olds: 53.9 and 62.0 overdose deaths per 100,000, respectively, for an increase of 15%, the NCHS said in the report.

The drugs now involved in overdose deaths are most often opioids, a change from 2001. That year, opioids were involved in 49% of all overdose deaths, but by 2021 that share had increased to 75%. The trend for opioid-related deaths almost matches that of overall deaths over the 20-year span, and the significantly increasing trend that began for all overdose deaths in 2013 closely follows that of synthetic opioids such as fentanyl and tramadol, the report shows.

Overdose deaths involving cocaine and psychostimulants such as methamphetamine, amphetamine, and methylphenidate also show similar increases. The cocaine-related death rate rose 22% from 2020 to 2021 and is up by 421% since 2012, while the corresponding increases for psychostimulant deaths were 33% and 2,400%, the NCHS said.

Although new COVID-19 cases in children, as measured by the American Academy of Pediatrics and the Children’s Hospital Association, have remained fairly steady in recent months, data from the Centers for Diseases Control and Prevention suggest that weekly cases took a big jump in early January.

For the most recent week covered in the AAP/CHA weekly report, Jan. 20-26, there were over 36,000 child COVID cases reported in the United States, an increase of 8.8% from the week before (Jan. 13-19). New cases for the first 2 weeks of the year – 31,000 for the week of Dec. 30 to Jan. 5 and 26,000 during Jan. 6-12 – were consistent with the AAP/CHA assertion that “weekly reported child cases have plateaued at an average of about 32,000 cases ... over the past 4 months.”

The CDC data, however, show that new cases doubled during the week of Jan. 1-7 to over 65,000, compared with the end of December, and stayed at that level for Jan. 8-14, and since CDC figures are subject to a 6-week reporting delay, the final numbers are likely to be even higher. The composition by age changed somewhat between the 2 weeks, though, as those aged 0-4 years went from almost half of all cases in the first week down to 40% in the second, while cases rose for children aged 5-11 and 12-15, based on data from the COVID-19 response team.

Emergency department visits for January do not show a corresponding increase. ED visits among children aged 0-11 years with COVID-19, measured as a percentage of all ED visits, declined over the course of the month, as did visits for 16- and 17-year-olds, while those aged 12-15 started the month at 1.4% and were at 1.4% on Jan. 27, with a slight dip down to 1.2% in between, the CDC said on its COVID Data Tracker. Daily hospitalizations for children aged 0-17 also declined through mid-January and did not reflect the jump in new cases.

Meanwhile, vaccinated children are still in the minority: 57% of those under age 18 have received no COVID vaccine yet, the AAP said in a separate report. Just 7.4% of children under age 2 years had received at least one dose as of Jan. 25, as had 10.1% of those aged 2-4 years, 39.6% of 5- to 11-year-olds and 71.8% of those 12-17 years old, according to the CDC, with corresponding figures for completion of the primary series at 3.5%, 5.3%, 32.5%, and 61.5%.

Although new COVID-19 cases in children, as measured by the American Academy of Pediatrics and the Children’s Hospital Association, have remained fairly steady in recent months, data from the Centers for Diseases Control and Prevention suggest that weekly cases took a big jump in early January.

For the most recent week covered in the AAP/CHA weekly report, Jan. 20-26, there were over 36,000 child COVID cases reported in the United States, an increase of 8.8% from the week before (Jan. 13-19). New cases for the first 2 weeks of the year – 31,000 for the week of Dec. 30 to Jan. 5 and 26,000 during Jan. 6-12 – were consistent with the AAP/CHA assertion that “weekly reported child cases have plateaued at an average of about 32,000 cases ... over the past 4 months.”

The CDC data, however, show that new cases doubled during the week of Jan. 1-7 to over 65,000, compared with the end of December, and stayed at that level for Jan. 8-14, and since CDC figures are subject to a 6-week reporting delay, the final numbers are likely to be even higher. The composition by age changed somewhat between the 2 weeks, though, as those aged 0-4 years went from almost half of all cases in the first week down to 40% in the second, while cases rose for children aged 5-11 and 12-15, based on data from the COVID-19 response team.

Emergency department visits for January do not show a corresponding increase. ED visits among children aged 0-11 years with COVID-19, measured as a percentage of all ED visits, declined over the course of the month, as did visits for 16- and 17-year-olds, while those aged 12-15 started the month at 1.4% and were at 1.4% on Jan. 27, with a slight dip down to 1.2% in between, the CDC said on its COVID Data Tracker. Daily hospitalizations for children aged 0-17 also declined through mid-January and did not reflect the jump in new cases.

Meanwhile, vaccinated children are still in the minority: 57% of those under age 18 have received no COVID vaccine yet, the AAP said in a separate report. Just 7.4% of children under age 2 years had received at least one dose as of Jan. 25, as had 10.1% of those aged 2-4 years, 39.6% of 5- to 11-year-olds and 71.8% of those 12-17 years old, according to the CDC, with corresponding figures for completion of the primary series at 3.5%, 5.3%, 32.5%, and 61.5%.

Although new COVID-19 cases in children, as measured by the American Academy of Pediatrics and the Children’s Hospital Association, have remained fairly steady in recent months, data from the Centers for Diseases Control and Prevention suggest that weekly cases took a big jump in early January.

For the most recent week covered in the AAP/CHA weekly report, Jan. 20-26, there were over 36,000 child COVID cases reported in the United States, an increase of 8.8% from the week before (Jan. 13-19). New cases for the first 2 weeks of the year – 31,000 for the week of Dec. 30 to Jan. 5 and 26,000 during Jan. 6-12 – were consistent with the AAP/CHA assertion that “weekly reported child cases have plateaued at an average of about 32,000 cases ... over the past 4 months.”

The CDC data, however, show that new cases doubled during the week of Jan. 1-7 to over 65,000, compared with the end of December, and stayed at that level for Jan. 8-14, and since CDC figures are subject to a 6-week reporting delay, the final numbers are likely to be even higher. The composition by age changed somewhat between the 2 weeks, though, as those aged 0-4 years went from almost half of all cases in the first week down to 40% in the second, while cases rose for children aged 5-11 and 12-15, based on data from the COVID-19 response team.

Emergency department visits for January do not show a corresponding increase. ED visits among children aged 0-11 years with COVID-19, measured as a percentage of all ED visits, declined over the course of the month, as did visits for 16- and 17-year-olds, while those aged 12-15 started the month at 1.4% and were at 1.4% on Jan. 27, with a slight dip down to 1.2% in between, the CDC said on its COVID Data Tracker. Daily hospitalizations for children aged 0-17 also declined through mid-January and did not reflect the jump in new cases.

Meanwhile, vaccinated children are still in the minority: 57% of those under age 18 have received no COVID vaccine yet, the AAP said in a separate report. Just 7.4% of children under age 2 years had received at least one dose as of Jan. 25, as had 10.1% of those aged 2-4 years, 39.6% of 5- to 11-year-olds and 71.8% of those 12-17 years old, according to the CDC, with corresponding figures for completion of the primary series at 3.5%, 5.3%, 32.5%, and 61.5%.

Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.

Rates of ED visits involving diagnosed COVID-19 in children had been rising since mid-November, 2022, but are now declining in early January, 2023. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.

The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.

The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.

The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.

The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.

Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.

Rates of ED visits involving diagnosed COVID-19 in children had been rising since mid-November, 2022, but are now declining in early January, 2023. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.

The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.

The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.

The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.

The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.

Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.

Rates of ED visits involving diagnosed COVID-19 in children had been rising since mid-November, 2022, but are now declining in early January, 2023. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.

The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.

The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.

The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.

The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.