Alicia Ault

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The US Food and Drug Administration (FDA) approved two GLP-1 agonists — both marketed by Novo Nordisk — for use in adolescents aged ≥ 12 years: Wegovy (semaglutide) in December 2022 and Saxenda (liraglutide) in December 2020. Novo Nordisk and Eli Lilly — which makes the dual glucose-dependent insulinotropic polypetide/GLP-1 agonist tirzepatide (Zepbound) — are also investigating the drugs for obesity in children as young as age 6 years. The crushing demand for semaglutide in the last year — driving a thriving market in compounded versions and online prescriptions — has made it increasingly difficult to find pharmacies that can fill prescriptions, pediatricians told this news organization.

“It’s been more difficult to get people initiated now than it was a year ago,” said Brooke Sweeney, MD, medical director of weight management services at Children’s Mercy in Kansas City, Missouri. “Because of the supply issues, for the most part we›re not starting anyone new because I don›t have enough medication to keep my patients on it who are already on it,” she said.

Sarah Raatz, MD, a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, said, “I actually haven’t really been prescribing many of these medications as of late.” Both liraglutide and semaglutide “are largely unavailable or quite hard to get a hold of,” Dr. Raatz told this news organization.

Susma Shanti Vaidya, MPH, MD, associate medical director of the IDEAL pediatric obesity clinic at Children›s National Hospital in Washington, DC, said that patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease. «I had one patient who had severe obstructive sleep apnea which resolved with semaglutide.»

But when they can’t find the medications, it can lead to a plateauing of weight loss and a reversal of hard-won victories, Dr. Vaidya said.

Insurance Denials Also Growing

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The US Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Insurance coverage for children — even for FDA-approved indications and the age 12-and-over population — has become increasingly difficult, said the pediatric obesity specialists. Insurers are also creating hurdles that make getting coverage more difficult, they said.

Some insurers track an adolescent’s weight trajectory, “and if they’re not meeting a certain response threshold set by the insurance company, then they can pull coverage and then we have to try to advocate for why continued coverage might be beneficial and necessary,” Dr. Raatz said.

Insurers in the region around Children’s Mercy are erecting similar barriers, said Sweeney. Interim weight loss goals are challenging in pediatrics — given that adolescents are constantly changing and growing, she said.

Dr. Vaidya said she’s had success with commercial insurers but that the Washington, DC, and Maryland Medicaid programs have been stingier.

All the pediatricians said they expect greater restrictions in 2024.

Dr. Vaidya said some patients told her they had been notified that prior authorization will be required for new prescriptions for a GLP-1 agonist.

“We will just kind of be forced to see what happens when these medications are taken away from patients who have benefited from them,” Dr. Raatz said.
 

Some Parents Asking for GLP-1 Agonists

Pediatric obesity specialists said more parents are asking if a GLP-1 agonist might be appropriate for their children this year than in 2022.

Dr. Sweeney said parents ask for the medications when they feel they have exhausted all other options for their children. “These parents are not coming because they are concerned about the cosmetic effects of the weight,” she said. In most cases, children she sees have been struggling for years with extreme hunger and lack of satiety and may have prediabetes or diabetes. Many are being bullied in school because of their weight. They have only marginally been helped by interventions suggested by primary care or dietitians or other specialists, Dr. Sweeney said.

“Starting semaglutide really is life-changing for some of these patients,” Dr. Vaidya said. One patient said, “it just stopped the food chatter,” she added, noting that the adolescent no longer felt ruled by cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. A third of all parents said they would be interested in having their children use the drugs if they were available.
 

Lifelong Medication?

Parents — and adolescents — are generally counseled that obesity is a chronic disease and GLP-1 agonists are likely a lifelong treatment.

With the medications, “our first step is to get induction of weight loss and get your set point decreased enough that we can get you to a healthier weight for your body,” Dr. Sweeney said.

She tells patients and families, “I can’t tell you that you’re necessarily going to be on this medication at this dose for the rest of your life, but you will need treatment for life.”

Based on current knowledge, the risks for lifelong obesity outweigh the risk for the medications. Dr. Sweeney said she would like to see more data. “There absolutely is an evidence gap, and we need more information on the long-term effectiveness and safety.”

“When we start kids on this medication, I’m very clear that we are going to try to get to the lowest effective dose,” Dr. Vaidya said. She also emphasizes to parents that the medications must be used in conjunction with continued lifestyle modifications. She expressed hope that as clinicians gain more experience, and patients’ comorbidities resolve, perhaps it will be possible in some cases to take individuals “off for a period of time, with the understanding that they might have to go back on in a few months.”

“We’re weighing the pros and cons of being on a medication long term but we’re also weighing the pros and cons of weight-related health complications long term,” Dr. Raatz said.

Dr. Raatz also said clinicians have much to learn about the long-term safety of GLP-1 agonists in their pediatric patients.

She tells parents and families, “we expect that this is going to be a long-term medication, and this is going to be something that we’re going to continue to monitor.”

Dr. Sweeney reports that she is a speaker and unpaid consultant on Rhythm Pharmaceuticals’ Imcivree (setmelanotide) medication and that she consults for Eli Lilly. Dr. Raatz is a coprincipal investigator for a Novo Nordisk trial of semaglutide in young children and will be a co-PI for a similar trial for Eli Lilly’s tirzepatide but receives no consulting fees or honoraria. Dr. Vaidya reported no conflicts.

A version of this article appeared on Medscape.com.

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The US Food and Drug Administration (FDA) approved two GLP-1 agonists — both marketed by Novo Nordisk — for use in adolescents aged ≥ 12 years: Wegovy (semaglutide) in December 2022 and Saxenda (liraglutide) in December 2020. Novo Nordisk and Eli Lilly — which makes the dual glucose-dependent insulinotropic polypetide/GLP-1 agonist tirzepatide (Zepbound) — are also investigating the drugs for obesity in children as young as age 6 years. The crushing demand for semaglutide in the last year — driving a thriving market in compounded versions and online prescriptions — has made it increasingly difficult to find pharmacies that can fill prescriptions, pediatricians told this news organization.

“It’s been more difficult to get people initiated now than it was a year ago,” said Brooke Sweeney, MD, medical director of weight management services at Children’s Mercy in Kansas City, Missouri. “Because of the supply issues, for the most part we›re not starting anyone new because I don›t have enough medication to keep my patients on it who are already on it,” she said.

Sarah Raatz, MD, a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, said, “I actually haven’t really been prescribing many of these medications as of late.” Both liraglutide and semaglutide “are largely unavailable or quite hard to get a hold of,” Dr. Raatz told this news organization.

Susma Shanti Vaidya, MPH, MD, associate medical director of the IDEAL pediatric obesity clinic at Children›s National Hospital in Washington, DC, said that patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease. «I had one patient who had severe obstructive sleep apnea which resolved with semaglutide.»

But when they can’t find the medications, it can lead to a plateauing of weight loss and a reversal of hard-won victories, Dr. Vaidya said.

Insurance Denials Also Growing

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The US Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Insurance coverage for children — even for FDA-approved indications and the age 12-and-over population — has become increasingly difficult, said the pediatric obesity specialists. Insurers are also creating hurdles that make getting coverage more difficult, they said.

Some insurers track an adolescent’s weight trajectory, “and if they’re not meeting a certain response threshold set by the insurance company, then they can pull coverage and then we have to try to advocate for why continued coverage might be beneficial and necessary,” Dr. Raatz said.

Insurers in the region around Children’s Mercy are erecting similar barriers, said Sweeney. Interim weight loss goals are challenging in pediatrics — given that adolescents are constantly changing and growing, she said.

Dr. Vaidya said she’s had success with commercial insurers but that the Washington, DC, and Maryland Medicaid programs have been stingier.

All the pediatricians said they expect greater restrictions in 2024.

Dr. Vaidya said some patients told her they had been notified that prior authorization will be required for new prescriptions for a GLP-1 agonist.

“We will just kind of be forced to see what happens when these medications are taken away from patients who have benefited from them,” Dr. Raatz said.
 

Some Parents Asking for GLP-1 Agonists

Pediatric obesity specialists said more parents are asking if a GLP-1 agonist might be appropriate for their children this year than in 2022.

Dr. Sweeney said parents ask for the medications when they feel they have exhausted all other options for their children. “These parents are not coming because they are concerned about the cosmetic effects of the weight,” she said. In most cases, children she sees have been struggling for years with extreme hunger and lack of satiety and may have prediabetes or diabetes. Many are being bullied in school because of their weight. They have only marginally been helped by interventions suggested by primary care or dietitians or other specialists, Dr. Sweeney said.

“Starting semaglutide really is life-changing for some of these patients,” Dr. Vaidya said. One patient said, “it just stopped the food chatter,” she added, noting that the adolescent no longer felt ruled by cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. A third of all parents said they would be interested in having their children use the drugs if they were available.
 

Lifelong Medication?

Parents — and adolescents — are generally counseled that obesity is a chronic disease and GLP-1 agonists are likely a lifelong treatment.

With the medications, “our first step is to get induction of weight loss and get your set point decreased enough that we can get you to a healthier weight for your body,” Dr. Sweeney said.

She tells patients and families, “I can’t tell you that you’re necessarily going to be on this medication at this dose for the rest of your life, but you will need treatment for life.”

Based on current knowledge, the risks for lifelong obesity outweigh the risk for the medications. Dr. Sweeney said she would like to see more data. “There absolutely is an evidence gap, and we need more information on the long-term effectiveness and safety.”

“When we start kids on this medication, I’m very clear that we are going to try to get to the lowest effective dose,” Dr. Vaidya said. She also emphasizes to parents that the medications must be used in conjunction with continued lifestyle modifications. She expressed hope that as clinicians gain more experience, and patients’ comorbidities resolve, perhaps it will be possible in some cases to take individuals “off for a period of time, with the understanding that they might have to go back on in a few months.”

“We’re weighing the pros and cons of being on a medication long term but we’re also weighing the pros and cons of weight-related health complications long term,” Dr. Raatz said.

Dr. Raatz also said clinicians have much to learn about the long-term safety of GLP-1 agonists in their pediatric patients.

She tells parents and families, “we expect that this is going to be a long-term medication, and this is going to be something that we’re going to continue to monitor.”

Dr. Sweeney reports that she is a speaker and unpaid consultant on Rhythm Pharmaceuticals’ Imcivree (setmelanotide) medication and that she consults for Eli Lilly. Dr. Raatz is a coprincipal investigator for a Novo Nordisk trial of semaglutide in young children and will be a co-PI for a similar trial for Eli Lilly’s tirzepatide but receives no consulting fees or honoraria. Dr. Vaidya reported no conflicts.

A version of this article appeared on Medscape.com.

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The US Food and Drug Administration (FDA) approved two GLP-1 agonists — both marketed by Novo Nordisk — for use in adolescents aged ≥ 12 years: Wegovy (semaglutide) in December 2022 and Saxenda (liraglutide) in December 2020. Novo Nordisk and Eli Lilly — which makes the dual glucose-dependent insulinotropic polypetide/GLP-1 agonist tirzepatide (Zepbound) — are also investigating the drugs for obesity in children as young as age 6 years. The crushing demand for semaglutide in the last year — driving a thriving market in compounded versions and online prescriptions — has made it increasingly difficult to find pharmacies that can fill prescriptions, pediatricians told this news organization.

“It’s been more difficult to get people initiated now than it was a year ago,” said Brooke Sweeney, MD, medical director of weight management services at Children’s Mercy in Kansas City, Missouri. “Because of the supply issues, for the most part we›re not starting anyone new because I don›t have enough medication to keep my patients on it who are already on it,” she said.

Sarah Raatz, MD, a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, said, “I actually haven’t really been prescribing many of these medications as of late.” Both liraglutide and semaglutide “are largely unavailable or quite hard to get a hold of,” Dr. Raatz told this news organization.

Susma Shanti Vaidya, MPH, MD, associate medical director of the IDEAL pediatric obesity clinic at Children›s National Hospital in Washington, DC, said that patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease. «I had one patient who had severe obstructive sleep apnea which resolved with semaglutide.»

But when they can’t find the medications, it can lead to a plateauing of weight loss and a reversal of hard-won victories, Dr. Vaidya said.

Insurance Denials Also Growing

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The US Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Insurance coverage for children — even for FDA-approved indications and the age 12-and-over population — has become increasingly difficult, said the pediatric obesity specialists. Insurers are also creating hurdles that make getting coverage more difficult, they said.

Some insurers track an adolescent’s weight trajectory, “and if they’re not meeting a certain response threshold set by the insurance company, then they can pull coverage and then we have to try to advocate for why continued coverage might be beneficial and necessary,” Dr. Raatz said.

Insurers in the region around Children’s Mercy are erecting similar barriers, said Sweeney. Interim weight loss goals are challenging in pediatrics — given that adolescents are constantly changing and growing, she said.

Dr. Vaidya said she’s had success with commercial insurers but that the Washington, DC, and Maryland Medicaid programs have been stingier.

All the pediatricians said they expect greater restrictions in 2024.

Dr. Vaidya said some patients told her they had been notified that prior authorization will be required for new prescriptions for a GLP-1 agonist.

“We will just kind of be forced to see what happens when these medications are taken away from patients who have benefited from them,” Dr. Raatz said.
 

Some Parents Asking for GLP-1 Agonists

Pediatric obesity specialists said more parents are asking if a GLP-1 agonist might be appropriate for their children this year than in 2022.

Dr. Sweeney said parents ask for the medications when they feel they have exhausted all other options for their children. “These parents are not coming because they are concerned about the cosmetic effects of the weight,” she said. In most cases, children she sees have been struggling for years with extreme hunger and lack of satiety and may have prediabetes or diabetes. Many are being bullied in school because of their weight. They have only marginally been helped by interventions suggested by primary care or dietitians or other specialists, Dr. Sweeney said.

“Starting semaglutide really is life-changing for some of these patients,” Dr. Vaidya said. One patient said, “it just stopped the food chatter,” she added, noting that the adolescent no longer felt ruled by cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. A third of all parents said they would be interested in having their children use the drugs if they were available.
 

Lifelong Medication?

Parents — and adolescents — are generally counseled that obesity is a chronic disease and GLP-1 agonists are likely a lifelong treatment.

With the medications, “our first step is to get induction of weight loss and get your set point decreased enough that we can get you to a healthier weight for your body,” Dr. Sweeney said.

She tells patients and families, “I can’t tell you that you’re necessarily going to be on this medication at this dose for the rest of your life, but you will need treatment for life.”

Based on current knowledge, the risks for lifelong obesity outweigh the risk for the medications. Dr. Sweeney said she would like to see more data. “There absolutely is an evidence gap, and we need more information on the long-term effectiveness and safety.”

“When we start kids on this medication, I’m very clear that we are going to try to get to the lowest effective dose,” Dr. Vaidya said. She also emphasizes to parents that the medications must be used in conjunction with continued lifestyle modifications. She expressed hope that as clinicians gain more experience, and patients’ comorbidities resolve, perhaps it will be possible in some cases to take individuals “off for a period of time, with the understanding that they might have to go back on in a few months.”

“We’re weighing the pros and cons of being on a medication long term but we’re also weighing the pros and cons of weight-related health complications long term,” Dr. Raatz said.

Dr. Raatz also said clinicians have much to learn about the long-term safety of GLP-1 agonists in their pediatric patients.

She tells parents and families, “we expect that this is going to be a long-term medication, and this is going to be something that we’re going to continue to monitor.”

Dr. Sweeney reports that she is a speaker and unpaid consultant on Rhythm Pharmaceuticals’ Imcivree (setmelanotide) medication and that she consults for Eli Lilly. Dr. Raatz is a coprincipal investigator for a Novo Nordisk trial of semaglutide in young children and will be a co-PI for a similar trial for Eli Lilly’s tirzepatide but receives no consulting fees or honoraria. Dr. Vaidya reported no conflicts.

A version of this article appeared on Medscape.com.

Claiming that both cosmetic and therapeutic uses of Botox and related products can lead to systemic iatrogenic botulism, Public Citizen is asking the Food and Drug Administration (FDA) to strengthen warnings on the labeling of all approved botulinum toxin products.

The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.

The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.

Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.

Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.

[embed:render:related:node:259026]

The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.

“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”

The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).

An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.

Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.

The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.

Claiming that both cosmetic and therapeutic uses of Botox and related products can lead to systemic iatrogenic botulism, Public Citizen is asking the Food and Drug Administration (FDA) to strengthen warnings on the labeling of all approved botulinum toxin products.

The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.

The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.

Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.

Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.

[embed:render:related:node:259026]

The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.

“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”

The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).

An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.

Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.

The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.

Claiming that both cosmetic and therapeutic uses of Botox and related products can lead to systemic iatrogenic botulism, Public Citizen is asking the Food and Drug Administration (FDA) to strengthen warnings on the labeling of all approved botulinum toxin products.

The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.

The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.

Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.

Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.

[embed:render:related:node:259026]

The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.

“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”

The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).

An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.

Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.

The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.

TOPLINE:

Lower-extremity (LE) lymphedema increases the risk for all types of skin cancer on the lower extremities.

METHODOLOGY:

• In the retrospective cohort study, researchers reviewed reports at Mayo Clinic for all patients who had LE lymphedema, limiting the review to those who had an ICD code for lymphedema.
• 4,437 patients with the ICD code from 2000 to 2020 were compared with 4,437 matched controls.
• The records of patients with skin cancer diagnoses were reviewed manually to determine whether the skin cancer, its management, or both were a cause of lymphedema; cancers that caused secondary lymphedema were excluded.
• This is the first large-scale study evaluating the association between LE lymphedema and LE skin cancer.

TAKEAWAY:

• 211 patients (4.6%) in the LE lymphedema group had any ICD code for LE skin cancer, compared with 89 (2%) in the control group.
• Among those with LE lymphedema, the risk for skin cancer was 1.98 times greater compared with those without lymphedema (95% confidence interval, 1.43-2.74; P < .001). Cases included all types of skin cancer.
• Nineteen of 24 patients with unilateral LE lymphedema had a history of immunosuppression.
• In the group of 24 patients with unilateral LE lymphedema, the lymphedematous LE was more likely to have one or more skin cancers than were the unaffected LE (87.5% vs. 33.3%; P < .05), and skin cancer was 2.65 times more likely to develop on the affected LE than in the unaffected LE (95% CI, 1.17-5.99; P = .02).

IN PRACTICE:

“Our findings suggest the need for a relatively high degree of suspicion of skin cancer at sites with lymphedema,” senior author, Afsaneh Alavi, MD, professor of dermatology at the Mayo Clinic, said in a Mayo Clinic press release reporting the results.

[embed:render:related:node:266500]

SOURCE:

The study was conducted by researchers at the Mayo Clinic and Meharry Medical College, Nashville. It was published in the November 2023 Mayo Clinic Proceedings.

LIMITATIONS:

This was a single-center retrospective study, and patients with LE lymphedema may be overdiagnosed with LE skin cancer because they have a greater number of examinations.

DISCLOSURES:

Dr. Alavi reports having been a consultant for AbbVie, Boehringer Ingelheim, InflaRx, Novartis, and UCB SA and an investigator for Processa Pharmaceuticals and Boehringer Ingelheim. The other authors had no disclosures.

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

TOPLINE:

Lower-extremity (LE) lymphedema increases the risk for all types of skin cancer on the lower extremities.

METHODOLOGY:

• In the retrospective cohort study, researchers reviewed reports at Mayo Clinic for all patients who had LE lymphedema, limiting the review to those who had an ICD code for lymphedema.
• 4,437 patients with the ICD code from 2000 to 2020 were compared with 4,437 matched controls.
• The records of patients with skin cancer diagnoses were reviewed manually to determine whether the skin cancer, its management, or both were a cause of lymphedema; cancers that caused secondary lymphedema were excluded.
• This is the first large-scale study evaluating the association between LE lymphedema and LE skin cancer.

TAKEAWAY:

• 211 patients (4.6%) in the LE lymphedema group had any ICD code for LE skin cancer, compared with 89 (2%) in the control group.
• Among those with LE lymphedema, the risk for skin cancer was 1.98 times greater compared with those without lymphedema (95% confidence interval, 1.43-2.74; P < .001). Cases included all types of skin cancer.
• Nineteen of 24 patients with unilateral LE lymphedema had a history of immunosuppression.
• In the group of 24 patients with unilateral LE lymphedema, the lymphedematous LE was more likely to have one or more skin cancers than were the unaffected LE (87.5% vs. 33.3%; P < .05), and skin cancer was 2.65 times more likely to develop on the affected LE than in the unaffected LE (95% CI, 1.17-5.99; P = .02).

IN PRACTICE:

“Our findings suggest the need for a relatively high degree of suspicion of skin cancer at sites with lymphedema,” senior author, Afsaneh Alavi, MD, professor of dermatology at the Mayo Clinic, said in a Mayo Clinic press release reporting the results.

[embed:render:related:node:266500]

SOURCE:

The study was conducted by researchers at the Mayo Clinic and Meharry Medical College, Nashville. It was published in the November 2023 Mayo Clinic Proceedings.

LIMITATIONS:

This was a single-center retrospective study, and patients with LE lymphedema may be overdiagnosed with LE skin cancer because they have a greater number of examinations.

DISCLOSURES:

Dr. Alavi reports having been a consultant for AbbVie, Boehringer Ingelheim, InflaRx, Novartis, and UCB SA and an investigator for Processa Pharmaceuticals and Boehringer Ingelheim. The other authors had no disclosures.

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

TOPLINE:

Lower-extremity (LE) lymphedema increases the risk for all types of skin cancer on the lower extremities.

METHODOLOGY:

• In the retrospective cohort study, researchers reviewed reports at Mayo Clinic for all patients who had LE lymphedema, limiting the review to those who had an ICD code for lymphedema.
• 4,437 patients with the ICD code from 2000 to 2020 were compared with 4,437 matched controls.
• The records of patients with skin cancer diagnoses were reviewed manually to determine whether the skin cancer, its management, or both were a cause of lymphedema; cancers that caused secondary lymphedema were excluded.
• This is the first large-scale study evaluating the association between LE lymphedema and LE skin cancer.

TAKEAWAY:

• 211 patients (4.6%) in the LE lymphedema group had any ICD code for LE skin cancer, compared with 89 (2%) in the control group.
• Among those with LE lymphedema, the risk for skin cancer was 1.98 times greater compared with those without lymphedema (95% confidence interval, 1.43-2.74; P < .001). Cases included all types of skin cancer.
• Nineteen of 24 patients with unilateral LE lymphedema had a history of immunosuppression.
• In the group of 24 patients with unilateral LE lymphedema, the lymphedematous LE was more likely to have one or more skin cancers than were the unaffected LE (87.5% vs. 33.3%; P < .05), and skin cancer was 2.65 times more likely to develop on the affected LE than in the unaffected LE (95% CI, 1.17-5.99; P = .02).

IN PRACTICE:

“Our findings suggest the need for a relatively high degree of suspicion of skin cancer at sites with lymphedema,” senior author, Afsaneh Alavi, MD, professor of dermatology at the Mayo Clinic, said in a Mayo Clinic press release reporting the results.

[embed:render:related:node:266500]

SOURCE:

The study was conducted by researchers at the Mayo Clinic and Meharry Medical College, Nashville. It was published in the November 2023 Mayo Clinic Proceedings.

LIMITATIONS:

This was a single-center retrospective study, and patients with LE lymphedema may be overdiagnosed with LE skin cancer because they have a greater number of examinations.

DISCLOSURES:

Dr. Alavi reports having been a consultant for AbbVie, Boehringer Ingelheim, InflaRx, Novartis, and UCB SA and an investigator for Processa Pharmaceuticals and Boehringer Ingelheim. The other authors had no disclosures.

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

Long COVID can exacerbate existing mental health disorders or cause new-onset psychiatric symptoms, but mental illness does not cause long COVID, experts say.

The consensus guidance statement on the assessment and treatment of mental health symptoms in patients with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID, was published online in Physical Medicine and Rehabilitation, the journal of the American Academy of Physical Medicine and Rehabilitation (AAPM&R).

The statement was developed by a task force that included experts from physical medicine, neurology, neuropsychiatry, neuropsychology, rehabilitation psychology, and primary care. It is the eighth guidance statement on long COVID published by AAPM&R).

“Many of our patients have reported experiences in which their symptoms of long COVID have been dismissed either by loved ones in the community, or also amongst health care providers, and they’ve been told their symptoms are in their head or due to a mental health condition, but that’s simply not true,” Abby L. Cheng, MD, a physiatrist at Barnes Jewish Hospital in St. Louis and a coauthor of the new guidance, said in a press briefing.

“Long COVID is real, and mental health conditions do not cause long COVID,” Dr. Cheng added.
 

Millions of Americans affected

Anxiety and depression have been reported as the second and third most common symptoms of long COVID, according to the guidance statement.

There is some evidence that the body’s inflammatory response – specifically, circulating cytokines – may contribute to the worsening of mental health symptoms or may bring on new symptoms of anxiety or depression, said Dr. Cheng. Cytokines may also affect levels of brain chemicals, such as serotonin, she said.

Researchers are also exploring whether the persistence of virus in the body, miniature blood clots in the body and brain, and changes to the gut microbiome affect the mental health of people with long COVID.

Some mental health symptoms – such as fatigue, brain fog, sleep disturbances, and tachycardia – can mimic long COVID symptoms, said Dr. Cheng.

The treatment is the same for someone with or without long COVID who has anxiety, depression, posttraumatic stress disorder, or other mental health conditions and includes treatment of coexisting medical conditions, supportive therapy and cognitive-behavioral therapy, and pharmacologic interventions, she said.

“Group therapy may have a particular role in the long COVID population because it really provides that social connection and awareness of additional resources in addition to validation of their experiences,” Dr. Cheng said.

The guidance suggests that primary care practitioners – if it’s within their comfort zone and they have the training – can be the first line for managing mental health symptoms.

But for patients whose symptoms are interfering with functioning and their ability to interact with the community, the guidance urges primary care clinicians to refer the patient to a specialist.

“It leaves the door open to them to practice within their scope but also gives guidance as to how, why, and who should be referred to the next level of care,” said Dr. Cheng.

Coauthor Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine at UT Health San Antonio, Texas, said that although fewer people are now getting long COVID, “it’s still an impactful number.”

The Centers for Disease Control and Prevention recently estimated that about 7% of American adults (18 million) and 1.3% of children had experienced long COVID.

Dr. Gutierrez said that it’s an evolving number, as some patients who have a second or third or fourth SARS-CoV-2 infection experience exacerbations of previous bouts of long COVID or develop long COVID for the first time.

“We are still getting new patients on a regular basis with long COVID,” said AAPM&R President Steven R. Flanagan, MD, a physical medicine specialist.

“This is a problem that really is not going away. It is still real and still ever-present,” said Dr. Flanagan, chair of rehabilitation medicine at NYU Langone Health.
 

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

Long COVID can exacerbate existing mental health disorders or cause new-onset psychiatric symptoms, but mental illness does not cause long COVID, experts say.

The consensus guidance statement on the assessment and treatment of mental health symptoms in patients with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID, was published online in Physical Medicine and Rehabilitation, the journal of the American Academy of Physical Medicine and Rehabilitation (AAPM&R).

The statement was developed by a task force that included experts from physical medicine, neurology, neuropsychiatry, neuropsychology, rehabilitation psychology, and primary care. It is the eighth guidance statement on long COVID published by AAPM&R).

“Many of our patients have reported experiences in which their symptoms of long COVID have been dismissed either by loved ones in the community, or also amongst health care providers, and they’ve been told their symptoms are in their head or due to a mental health condition, but that’s simply not true,” Abby L. Cheng, MD, a physiatrist at Barnes Jewish Hospital in St. Louis and a coauthor of the new guidance, said in a press briefing.

“Long COVID is real, and mental health conditions do not cause long COVID,” Dr. Cheng added.
 

Millions of Americans affected

Anxiety and depression have been reported as the second and third most common symptoms of long COVID, according to the guidance statement.

There is some evidence that the body’s inflammatory response – specifically, circulating cytokines – may contribute to the worsening of mental health symptoms or may bring on new symptoms of anxiety or depression, said Dr. Cheng. Cytokines may also affect levels of brain chemicals, such as serotonin, she said.

Researchers are also exploring whether the persistence of virus in the body, miniature blood clots in the body and brain, and changes to the gut microbiome affect the mental health of people with long COVID.

Some mental health symptoms – such as fatigue, brain fog, sleep disturbances, and tachycardia – can mimic long COVID symptoms, said Dr. Cheng.

The treatment is the same for someone with or without long COVID who has anxiety, depression, posttraumatic stress disorder, or other mental health conditions and includes treatment of coexisting medical conditions, supportive therapy and cognitive-behavioral therapy, and pharmacologic interventions, she said.

“Group therapy may have a particular role in the long COVID population because it really provides that social connection and awareness of additional resources in addition to validation of their experiences,” Dr. Cheng said.

The guidance suggests that primary care practitioners – if it’s within their comfort zone and they have the training – can be the first line for managing mental health symptoms.

But for patients whose symptoms are interfering with functioning and their ability to interact with the community, the guidance urges primary care clinicians to refer the patient to a specialist.

“It leaves the door open to them to practice within their scope but also gives guidance as to how, why, and who should be referred to the next level of care,” said Dr. Cheng.

Coauthor Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine at UT Health San Antonio, Texas, said that although fewer people are now getting long COVID, “it’s still an impactful number.”

The Centers for Disease Control and Prevention recently estimated that about 7% of American adults (18 million) and 1.3% of children had experienced long COVID.

Dr. Gutierrez said that it’s an evolving number, as some patients who have a second or third or fourth SARS-CoV-2 infection experience exacerbations of previous bouts of long COVID or develop long COVID for the first time.

“We are still getting new patients on a regular basis with long COVID,” said AAPM&R President Steven R. Flanagan, MD, a physical medicine specialist.

“This is a problem that really is not going away. It is still real and still ever-present,” said Dr. Flanagan, chair of rehabilitation medicine at NYU Langone Health.
 

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

Long COVID can exacerbate existing mental health disorders or cause new-onset psychiatric symptoms, but mental illness does not cause long COVID, experts say.

The consensus guidance statement on the assessment and treatment of mental health symptoms in patients with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID, was published online in Physical Medicine and Rehabilitation, the journal of the American Academy of Physical Medicine and Rehabilitation (AAPM&R).

The statement was developed by a task force that included experts from physical medicine, neurology, neuropsychiatry, neuropsychology, rehabilitation psychology, and primary care. It is the eighth guidance statement on long COVID published by AAPM&R).

“Many of our patients have reported experiences in which their symptoms of long COVID have been dismissed either by loved ones in the community, or also amongst health care providers, and they’ve been told their symptoms are in their head or due to a mental health condition, but that’s simply not true,” Abby L. Cheng, MD, a physiatrist at Barnes Jewish Hospital in St. Louis and a coauthor of the new guidance, said in a press briefing.

“Long COVID is real, and mental health conditions do not cause long COVID,” Dr. Cheng added.
 

Millions of Americans affected

Anxiety and depression have been reported as the second and third most common symptoms of long COVID, according to the guidance statement.

There is some evidence that the body’s inflammatory response – specifically, circulating cytokines – may contribute to the worsening of mental health symptoms or may bring on new symptoms of anxiety or depression, said Dr. Cheng. Cytokines may also affect levels of brain chemicals, such as serotonin, she said.

Researchers are also exploring whether the persistence of virus in the body, miniature blood clots in the body and brain, and changes to the gut microbiome affect the mental health of people with long COVID.

Some mental health symptoms – such as fatigue, brain fog, sleep disturbances, and tachycardia – can mimic long COVID symptoms, said Dr. Cheng.

The treatment is the same for someone with or without long COVID who has anxiety, depression, posttraumatic stress disorder, or other mental health conditions and includes treatment of coexisting medical conditions, supportive therapy and cognitive-behavioral therapy, and pharmacologic interventions, she said.

“Group therapy may have a particular role in the long COVID population because it really provides that social connection and awareness of additional resources in addition to validation of their experiences,” Dr. Cheng said.

The guidance suggests that primary care practitioners – if it’s within their comfort zone and they have the training – can be the first line for managing mental health symptoms.

But for patients whose symptoms are interfering with functioning and their ability to interact with the community, the guidance urges primary care clinicians to refer the patient to a specialist.

“It leaves the door open to them to practice within their scope but also gives guidance as to how, why, and who should be referred to the next level of care,” said Dr. Cheng.

Coauthor Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine at UT Health San Antonio, Texas, said that although fewer people are now getting long COVID, “it’s still an impactful number.”

The Centers for Disease Control and Prevention recently estimated that about 7% of American adults (18 million) and 1.3% of children had experienced long COVID.

Dr. Gutierrez said that it’s an evolving number, as some patients who have a second or third or fourth SARS-CoV-2 infection experience exacerbations of previous bouts of long COVID or develop long COVID for the first time.

“We are still getting new patients on a regular basis with long COVID,” said AAPM&R President Steven R. Flanagan, MD, a physical medicine specialist.

“This is a problem that really is not going away. It is still real and still ever-present,” said Dr. Flanagan, chair of rehabilitation medicine at NYU Langone Health.
 

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

A recent survey found that less than half of pharmacies in the Washington area had a 30-day supply of either 2.5-mg or 10-mg tablets of oral minoxidil, used for both hair loss and hypertension.

Patients are not finding out until they go to pick up their prescription, which can result in an interruption of treatment – and, potentially a loss of hard-earned hair gain, said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was the lead author of the survey, published online on Oct. 26 as a research letter in the Journal of Drugs in Dermatology.

Going off low-dose oral minoxidil may spark a telogen effluvium event, and that is very disappointing to patients, Dr. Friedman told this news organization.

“There needs to be some system that alerts us,” he said. “Even if it’s a minor shortage, just so we’re aware. We can then prepare patients,” he added, noting that it would be better for someone to be taking a lower-than-normal dose rather than no medication at all while they wait for a refill.

Minoxidil has long been approved in a topical formulation to treat androgenetic alopecia, but a low-dose oral form has gained currency in the wake of findings that it might more effectively treat hair loss, and is without side effects. A New York Times article in August 2022 touting low-dose oral minoxidil as a cheap and effective hair loss drug appeared to ignite interest in this option. In May, 2023, researchers reporting in JAMA Network Open demonstrated a significant uptick in prescriptions for oral minoxidil in the wake of the article’s publication.

Oral minoxidil is approved by the Food and Drug Administration only for hypertension, but dermatologists are prescribing it off-label at a lower dose for hair loss. Dr. Friedman said it’s not clear whether the shortages his team found are national in scope, or whether they are a result of increased demand, or other factors.

After several patients told him they were having trouble filling minoxidil prescriptions, and colleagues said they’d had patients with similar experiences, Dr. Friedman and his colleagues undertook the survey. In the first week of October 2023, they contacted 277 pharmacies by phone in Washington and surrounding Virginia and Maryland counties. The pharmacies were CVS, Giant, Walgreens, and Harris Teeter.

[embed:render:related:node:264930]

Of the 277 pharmacies they contacted, 40% (111) reported availability of 2.5-mg tablets for a 30-day supply, and just under 30% (82) reported having 10-mg tablets for a 30-day supply.

For treating hair loss, most patients are prescribed 2.5-mg pills, with starting doses ranging from 0.625 mg to 5 mg twice a day, Dr. Friedman said. The 10-mg dose is more frequently prescribed for hypertension.

Only 28% (19 of 67) of the Maryland pharmacies had 30-day supplies of 2.5-mg tablets on hand, and just 22% (15) of the Maryland pharmacies had 30-day supplies of 10-mg tablets. In Northern Virginia, 44% (63 of 143) of the pharmacies had 30-day supplies of the 2.5 mg tablets, as did just 43% (29 of 67) of the Washington pharmacies.

Dr. Friedman said he has started giving patients paper prescriptions they can use to shop around, rather than electronically sending a prescription to a particular pharmacy.

Neither the Food and Drug Administration nor the American Society of Health System Pharmacists lists oral minoxidil as a drug in shortage.

Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP, said the organization received a report from wholesalers in mid-September showing spotty oral minoxidil availability, with the drug on backorder with some manufacturers.  ASHP's shortages list is compiled from reports from physicians, manufacturers and wholesalers, he said.

Under what he calls "blue sky conditions," pharmacies using a just-in-time inventory model should be able to fill prescriptions within hours or days, which might explain why some pharmacies in the Washington, DC area survey did not have a 30-day supply on hand, he said. However, Dr. Ganio noted that the causes of drug shortages are complex and multi-factorial. For now, he said there have been no oral minoxidil shortage reports since mid-September.

But Dr. Friedman said some of his patients have waited weeks for a new supply – and that no one is aware of the problem until the last moment.

The lack of alerts or transparency “also erodes the physician-patient relationship because there’s this expectation of the patient that we should have known this,” said Dr. Friedman.

Dr. Friedman reports no relevant financial relationships.

This story was updated on 11/2/2023.

A recent survey found that less than half of pharmacies in the Washington area had a 30-day supply of either 2.5-mg or 10-mg tablets of oral minoxidil, used for both hair loss and hypertension.

Patients are not finding out until they go to pick up their prescription, which can result in an interruption of treatment – and, potentially a loss of hard-earned hair gain, said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was the lead author of the survey, published online on Oct. 26 as a research letter in the Journal of Drugs in Dermatology.

Going off low-dose oral minoxidil may spark a telogen effluvium event, and that is very disappointing to patients, Dr. Friedman told this news organization.

“There needs to be some system that alerts us,” he said. “Even if it’s a minor shortage, just so we’re aware. We can then prepare patients,” he added, noting that it would be better for someone to be taking a lower-than-normal dose rather than no medication at all while they wait for a refill.

Minoxidil has long been approved in a topical formulation to treat androgenetic alopecia, but a low-dose oral form has gained currency in the wake of findings that it might more effectively treat hair loss, and is without side effects. A New York Times article in August 2022 touting low-dose oral minoxidil as a cheap and effective hair loss drug appeared to ignite interest in this option. In May, 2023, researchers reporting in JAMA Network Open demonstrated a significant uptick in prescriptions for oral minoxidil in the wake of the article’s publication.

Oral minoxidil is approved by the Food and Drug Administration only for hypertension, but dermatologists are prescribing it off-label at a lower dose for hair loss. Dr. Friedman said it’s not clear whether the shortages his team found are national in scope, or whether they are a result of increased demand, or other factors.

After several patients told him they were having trouble filling minoxidil prescriptions, and colleagues said they’d had patients with similar experiences, Dr. Friedman and his colleagues undertook the survey. In the first week of October 2023, they contacted 277 pharmacies by phone in Washington and surrounding Virginia and Maryland counties. The pharmacies were CVS, Giant, Walgreens, and Harris Teeter.

[embed:render:related:node:264930]

Of the 277 pharmacies they contacted, 40% (111) reported availability of 2.5-mg tablets for a 30-day supply, and just under 30% (82) reported having 10-mg tablets for a 30-day supply.

For treating hair loss, most patients are prescribed 2.5-mg pills, with starting doses ranging from 0.625 mg to 5 mg twice a day, Dr. Friedman said. The 10-mg dose is more frequently prescribed for hypertension.

Only 28% (19 of 67) of the Maryland pharmacies had 30-day supplies of 2.5-mg tablets on hand, and just 22% (15) of the Maryland pharmacies had 30-day supplies of 10-mg tablets. In Northern Virginia, 44% (63 of 143) of the pharmacies had 30-day supplies of the 2.5 mg tablets, as did just 43% (29 of 67) of the Washington pharmacies.

Dr. Friedman said he has started giving patients paper prescriptions they can use to shop around, rather than electronically sending a prescription to a particular pharmacy.

Neither the Food and Drug Administration nor the American Society of Health System Pharmacists lists oral minoxidil as a drug in shortage.

Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP, said the organization received a report from wholesalers in mid-September showing spotty oral minoxidil availability, with the drug on backorder with some manufacturers.  ASHP's shortages list is compiled from reports from physicians, manufacturers and wholesalers, he said.

Under what he calls "blue sky conditions," pharmacies using a just-in-time inventory model should be able to fill prescriptions within hours or days, which might explain why some pharmacies in the Washington, DC area survey did not have a 30-day supply on hand, he said. However, Dr. Ganio noted that the causes of drug shortages are complex and multi-factorial. For now, he said there have been no oral minoxidil shortage reports since mid-September.

But Dr. Friedman said some of his patients have waited weeks for a new supply – and that no one is aware of the problem until the last moment.

The lack of alerts or transparency “also erodes the physician-patient relationship because there’s this expectation of the patient that we should have known this,” said Dr. Friedman.

Dr. Friedman reports no relevant financial relationships.

This story was updated on 11/2/2023.

A recent survey found that less than half of pharmacies in the Washington area had a 30-day supply of either 2.5-mg or 10-mg tablets of oral minoxidil, used for both hair loss and hypertension.

Patients are not finding out until they go to pick up their prescription, which can result in an interruption of treatment – and, potentially a loss of hard-earned hair gain, said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was the lead author of the survey, published online on Oct. 26 as a research letter in the Journal of Drugs in Dermatology.

Going off low-dose oral minoxidil may spark a telogen effluvium event, and that is very disappointing to patients, Dr. Friedman told this news organization.

“There needs to be some system that alerts us,” he said. “Even if it’s a minor shortage, just so we’re aware. We can then prepare patients,” he added, noting that it would be better for someone to be taking a lower-than-normal dose rather than no medication at all while they wait for a refill.

Minoxidil has long been approved in a topical formulation to treat androgenetic alopecia, but a low-dose oral form has gained currency in the wake of findings that it might more effectively treat hair loss, and is without side effects. A New York Times article in August 2022 touting low-dose oral minoxidil as a cheap and effective hair loss drug appeared to ignite interest in this option. In May, 2023, researchers reporting in JAMA Network Open demonstrated a significant uptick in prescriptions for oral minoxidil in the wake of the article’s publication.

Oral minoxidil is approved by the Food and Drug Administration only for hypertension, but dermatologists are prescribing it off-label at a lower dose for hair loss. Dr. Friedman said it’s not clear whether the shortages his team found are national in scope, or whether they are a result of increased demand, or other factors.

After several patients told him they were having trouble filling minoxidil prescriptions, and colleagues said they’d had patients with similar experiences, Dr. Friedman and his colleagues undertook the survey. In the first week of October 2023, they contacted 277 pharmacies by phone in Washington and surrounding Virginia and Maryland counties. The pharmacies were CVS, Giant, Walgreens, and Harris Teeter.

[embed:render:related:node:264930]

Of the 277 pharmacies they contacted, 40% (111) reported availability of 2.5-mg tablets for a 30-day supply, and just under 30% (82) reported having 10-mg tablets for a 30-day supply.

For treating hair loss, most patients are prescribed 2.5-mg pills, with starting doses ranging from 0.625 mg to 5 mg twice a day, Dr. Friedman said. The 10-mg dose is more frequently prescribed for hypertension.

Only 28% (19 of 67) of the Maryland pharmacies had 30-day supplies of 2.5-mg tablets on hand, and just 22% (15) of the Maryland pharmacies had 30-day supplies of 10-mg tablets. In Northern Virginia, 44% (63 of 143) of the pharmacies had 30-day supplies of the 2.5 mg tablets, as did just 43% (29 of 67) of the Washington pharmacies.

Dr. Friedman said he has started giving patients paper prescriptions they can use to shop around, rather than electronically sending a prescription to a particular pharmacy.

Neither the Food and Drug Administration nor the American Society of Health System Pharmacists lists oral minoxidil as a drug in shortage.

Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP, said the organization received a report from wholesalers in mid-September showing spotty oral minoxidil availability, with the drug on backorder with some manufacturers.  ASHP's shortages list is compiled from reports from physicians, manufacturers and wholesalers, he said.

Under what he calls "blue sky conditions," pharmacies using a just-in-time inventory model should be able to fill prescriptions within hours or days, which might explain why some pharmacies in the Washington, DC area survey did not have a 30-day supply on hand, he said. However, Dr. Ganio noted that the causes of drug shortages are complex and multi-factorial. For now, he said there have been no oral minoxidil shortage reports since mid-September.

But Dr. Friedman said some of his patients have waited weeks for a new supply – and that no one is aware of the problem until the last moment.

The lack of alerts or transparency “also erodes the physician-patient relationship because there’s this expectation of the patient that we should have known this,” said Dr. Friedman.

Dr. Friedman reports no relevant financial relationships.

This story was updated on 11/2/2023.

When the U.S. Supreme Court overturned Roe v. Wade abortion rights last year, residency programs and ob.gyn. residents in states that ban or restrict abortions began scrambling to find alternative training sites to fulfill required clinical rotations in the procedure.

The Accreditation Council for Graduate Medical Education requires ob.gyn. residents – unless they have a religious or moral exemption – to undergo abortion training to complete their programs. In states with bans or restrictions on family planning services or abortions, resident training must be received at institutions that are out of state.

Some residency programs are just beginning to coordinate out-of-state training, while others are further along in their offerings. There’s no formal matching process, and it remains unclear who will cover the costs of residents training elsewhere for a month.

These uncertainties, along with lack of coordination about malpractice, clinical rotations, and limited faculty, leave some program directors skeptical they’ll be able to keep up with demand for out-of-state slots. They are also wary of harming their own residents’ educational and clinical opportunities.

A 3rd-year ob.gyn. resident, who didn’t want to give her name or residency program for fear of backlash against her home institution, told this news organization that the Catholic-affiliated site is trying to avoid drawing attention to its minimal abortion training in a restrictive Midwest state. She knew after the Supreme Court’s decision in Dobbs v. Jackson she’d have to look outside the program for more complex abortion training.

While she could learn dilation and curettage or other first-trimester or early–second-trimester procedures at the Midwest program, she said she couldn’t learn dilation and evacuation.

A mentor at her program connected her with a residency program at the University of New Mexico, where she recently started a 5-week family planning rotation. She is the first out-of-state resident hosted by UNM. Currently, UNM has six ob.gyn. residents per class year, for a total of 36, and six family planning fellows.

The ob.gyn. resident is staying with a friend at no cost, and her home institution still pays her salary. But she still must pay the mortgage on a home she can’t live in while away and misses being part of a community where she’s built a life over the past 2 years.

“There’s a part of you that’s just angry that you can’t do this for the women ... in your state,” she said. “Unfortunately, there isn’t a formalized program for ob.gyn. residents interested in more advanced training to be matched with a program that has the ability to offer that training. It’s very much a word-of-mouth and who-you-know situation. For people without those connections, it can be difficult to obtain this training unless they are interested in a formal fellowship.”

This year, about 1,500 ob.gyn. residents matched into 280 residency programs, according to the National Residency Matching Program.

Colwill_Alyssa_OR_web.jpg

Alyssa Colwill, MD, assistant professor of obstetrics and gynecology at Oregon Health and Science University and director of the ob.gyn. Ryan Residency Program at OHSU, estimated that 1,000 ob.gyn. residents per year will seek out-of-state abortion training. The estimate is based on the number of residents in programs in states with restrictions.

The Ryan Program, which began in 1999, helps ob.gyn. residency programs provide training in abortion and contraception care (family planning) as a required rotation.
 

Connecting programs

Ryan-affiliated residencies have been helping connect programs in states with abortion bans and restrictions to programs in states with more liberal laws.

Twelve of the 100 Ryan programs sent residents out of state in the past academic year, and 15 will follow this year. More are expected soon, said Kristin Simonson, MA, director of programs and operations at the Ryan Residency Program, headquartered at the Bixby Center for Global Reproductive Health at the University of California, San Francisco.

Before the Dobbs decision, very few programs considered next steps to train ob.gyn. residents if abortions became illegal, Ms. Simonson said. “I think a lot of people just kind of were waiting and seeing ... and hoping that they wouldn’t have to make any drastic plans. It was hard to motivate people to have a plan B ready to go,” she said.

“Almost all of us working in this field had a really bad feeling,” said Courtney G. Forbis, MD, UNM assistant professor of ob.gyn. and Ryan Residency director. She and colleagues began planning for the future months ahead of the court decision. But the program wasn’t able to begin accepting out-of-state residents until now, she said. “We are trying to use this experience to see what we can accommodate in the future.”

OHSU also began planning for alternative training when it learned of the leaked Supreme Court decision, Dr. Colwill said. “We decided that we had the bandwidth and opportunity to train more individuals that were going to lose access to services and educational opportunities,” she said.

The university ran a 4-week test rotation last fall. So far, six residents and one fellow have come from out of the state, said Dr. Colwill. OHSU hopes to have 10 more in the coming year. The out-of-state learners will join 32 ob.gyn. residents and 12 fellows who were already in the program, she said.

To ease residents’ integration into an away program, the Ryan Program – along with the American College of Obstetricians and Gynecologists, the Council on Resident Education in Obstetrics and Gynecology, and Innovating Education in Reproductive Health – recently began offering a free, web-based patient-centered abortion education curriculum.

Connolly_AnnaMarie_DC_web.jpg

The course supplements in-person clinical training in abortion care and prepares residents traveling and transitioning into another program to begin learning new skills on their first day, AnnaMarie Connolly, MD, ACOG’s chief of education and academic affairs, said in a prepared statement.
 

Training costs

Residents and their institutions also face additional costs. The home institution that loses a resident for a few weeks to a month has to determine how to cover the care not provided while they are away, Ms. Simonson said. Residents may incur expenses for transportation, housing, food, and other things while out of state.

OHSU covers transportation and housing through its abortion care and training fund, but there are other factors to consider, Dr. Colwill said. For example, the home and host programs have to coordinate licensing, malpractice, and line up rotation dates, she said.

Among other complications, UNM wasn’t able to set up an agreement so that its new resident could participate in a rotation at Planned Parenthood. “We have the clinical volume to accommodate another learner,” Dr. Forbis said. But the program has to balance resources, such as “trying to make sure we don’t have one faculty [member] assigned to too many learners at one time,” she said.

Given the logistic and financial challenges, programs may not be able to ensure that all residents who need abortion training receive it, said Ms. Simonson.

The Ryan Program, for instance, can’t help the more than 100 residency programs in states where abortions are currently illegal, she said.

UNM is trying to partner with specific programs, such as those in the state of Texas where abortion is banned, to train its residents each year, Dr. Forbis said.

OHSU also will look for opportunities to train as many residents as possible, Dr. Colwill said, “but I don’t think we’ll ever be able to fill that gap of 1,000 residents that need this training.”

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

When the U.S. Supreme Court overturned Roe v. Wade abortion rights last year, residency programs and ob.gyn. residents in states that ban or restrict abortions began scrambling to find alternative training sites to fulfill required clinical rotations in the procedure.

The Accreditation Council for Graduate Medical Education requires ob.gyn. residents – unless they have a religious or moral exemption – to undergo abortion training to complete their programs. In states with bans or restrictions on family planning services or abortions, resident training must be received at institutions that are out of state.

Some residency programs are just beginning to coordinate out-of-state training, while others are further along in their offerings. There’s no formal matching process, and it remains unclear who will cover the costs of residents training elsewhere for a month.

These uncertainties, along with lack of coordination about malpractice, clinical rotations, and limited faculty, leave some program directors skeptical they’ll be able to keep up with demand for out-of-state slots. They are also wary of harming their own residents’ educational and clinical opportunities.

A 3rd-year ob.gyn. resident, who didn’t want to give her name or residency program for fear of backlash against her home institution, told this news organization that the Catholic-affiliated site is trying to avoid drawing attention to its minimal abortion training in a restrictive Midwest state. She knew after the Supreme Court’s decision in Dobbs v. Jackson she’d have to look outside the program for more complex abortion training.

While she could learn dilation and curettage or other first-trimester or early–second-trimester procedures at the Midwest program, she said she couldn’t learn dilation and evacuation.

A mentor at her program connected her with a residency program at the University of New Mexico, where she recently started a 5-week family planning rotation. She is the first out-of-state resident hosted by UNM. Currently, UNM has six ob.gyn. residents per class year, for a total of 36, and six family planning fellows.

The ob.gyn. resident is staying with a friend at no cost, and her home institution still pays her salary. But she still must pay the mortgage on a home she can’t live in while away and misses being part of a community where she’s built a life over the past 2 years.

“There’s a part of you that’s just angry that you can’t do this for the women ... in your state,” she said. “Unfortunately, there isn’t a formalized program for ob.gyn. residents interested in more advanced training to be matched with a program that has the ability to offer that training. It’s very much a word-of-mouth and who-you-know situation. For people without those connections, it can be difficult to obtain this training unless they are interested in a formal fellowship.”

This year, about 1,500 ob.gyn. residents matched into 280 residency programs, according to the National Residency Matching Program.

Colwill_Alyssa_OR_web.jpg

Alyssa Colwill, MD, assistant professor of obstetrics and gynecology at Oregon Health and Science University and director of the ob.gyn. Ryan Residency Program at OHSU, estimated that 1,000 ob.gyn. residents per year will seek out-of-state abortion training. The estimate is based on the number of residents in programs in states with restrictions.

The Ryan Program, which began in 1999, helps ob.gyn. residency programs provide training in abortion and contraception care (family planning) as a required rotation.
 

Connecting programs

Ryan-affiliated residencies have been helping connect programs in states with abortion bans and restrictions to programs in states with more liberal laws.

Twelve of the 100 Ryan programs sent residents out of state in the past academic year, and 15 will follow this year. More are expected soon, said Kristin Simonson, MA, director of programs and operations at the Ryan Residency Program, headquartered at the Bixby Center for Global Reproductive Health at the University of California, San Francisco.

Before the Dobbs decision, very few programs considered next steps to train ob.gyn. residents if abortions became illegal, Ms. Simonson said. “I think a lot of people just kind of were waiting and seeing ... and hoping that they wouldn’t have to make any drastic plans. It was hard to motivate people to have a plan B ready to go,” she said.

“Almost all of us working in this field had a really bad feeling,” said Courtney G. Forbis, MD, UNM assistant professor of ob.gyn. and Ryan Residency director. She and colleagues began planning for the future months ahead of the court decision. But the program wasn’t able to begin accepting out-of-state residents until now, she said. “We are trying to use this experience to see what we can accommodate in the future.”

OHSU also began planning for alternative training when it learned of the leaked Supreme Court decision, Dr. Colwill said. “We decided that we had the bandwidth and opportunity to train more individuals that were going to lose access to services and educational opportunities,” she said.

The university ran a 4-week test rotation last fall. So far, six residents and one fellow have come from out of the state, said Dr. Colwill. OHSU hopes to have 10 more in the coming year. The out-of-state learners will join 32 ob.gyn. residents and 12 fellows who were already in the program, she said.

To ease residents’ integration into an away program, the Ryan Program – along with the American College of Obstetricians and Gynecologists, the Council on Resident Education in Obstetrics and Gynecology, and Innovating Education in Reproductive Health – recently began offering a free, web-based patient-centered abortion education curriculum.

Connolly_AnnaMarie_DC_web.jpg

The course supplements in-person clinical training in abortion care and prepares residents traveling and transitioning into another program to begin learning new skills on their first day, AnnaMarie Connolly, MD, ACOG’s chief of education and academic affairs, said in a prepared statement.
 

Training costs

Residents and their institutions also face additional costs. The home institution that loses a resident for a few weeks to a month has to determine how to cover the care not provided while they are away, Ms. Simonson said. Residents may incur expenses for transportation, housing, food, and other things while out of state.

OHSU covers transportation and housing through its abortion care and training fund, but there are other factors to consider, Dr. Colwill said. For example, the home and host programs have to coordinate licensing, malpractice, and line up rotation dates, she said.

Among other complications, UNM wasn’t able to set up an agreement so that its new resident could participate in a rotation at Planned Parenthood. “We have the clinical volume to accommodate another learner,” Dr. Forbis said. But the program has to balance resources, such as “trying to make sure we don’t have one faculty [member] assigned to too many learners at one time,” she said.

Given the logistic and financial challenges, programs may not be able to ensure that all residents who need abortion training receive it, said Ms. Simonson.

The Ryan Program, for instance, can’t help the more than 100 residency programs in states where abortions are currently illegal, she said.

UNM is trying to partner with specific programs, such as those in the state of Texas where abortion is banned, to train its residents each year, Dr. Forbis said.

OHSU also will look for opportunities to train as many residents as possible, Dr. Colwill said, “but I don’t think we’ll ever be able to fill that gap of 1,000 residents that need this training.”

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

When the U.S. Supreme Court overturned Roe v. Wade abortion rights last year, residency programs and ob.gyn. residents in states that ban or restrict abortions began scrambling to find alternative training sites to fulfill required clinical rotations in the procedure.

The Accreditation Council for Graduate Medical Education requires ob.gyn. residents – unless they have a religious or moral exemption – to undergo abortion training to complete their programs. In states with bans or restrictions on family planning services or abortions, resident training must be received at institutions that are out of state.

Some residency programs are just beginning to coordinate out-of-state training, while others are further along in their offerings. There’s no formal matching process, and it remains unclear who will cover the costs of residents training elsewhere for a month.

These uncertainties, along with lack of coordination about malpractice, clinical rotations, and limited faculty, leave some program directors skeptical they’ll be able to keep up with demand for out-of-state slots. They are also wary of harming their own residents’ educational and clinical opportunities.

A 3rd-year ob.gyn. resident, who didn’t want to give her name or residency program for fear of backlash against her home institution, told this news organization that the Catholic-affiliated site is trying to avoid drawing attention to its minimal abortion training in a restrictive Midwest state. She knew after the Supreme Court’s decision in Dobbs v. Jackson she’d have to look outside the program for more complex abortion training.

While she could learn dilation and curettage or other first-trimester or early–second-trimester procedures at the Midwest program, she said she couldn’t learn dilation and evacuation.

A mentor at her program connected her with a residency program at the University of New Mexico, where she recently started a 5-week family planning rotation. She is the first out-of-state resident hosted by UNM. Currently, UNM has six ob.gyn. residents per class year, for a total of 36, and six family planning fellows.

The ob.gyn. resident is staying with a friend at no cost, and her home institution still pays her salary. But she still must pay the mortgage on a home she can’t live in while away and misses being part of a community where she’s built a life over the past 2 years.

“There’s a part of you that’s just angry that you can’t do this for the women ... in your state,” she said. “Unfortunately, there isn’t a formalized program for ob.gyn. residents interested in more advanced training to be matched with a program that has the ability to offer that training. It’s very much a word-of-mouth and who-you-know situation. For people without those connections, it can be difficult to obtain this training unless they are interested in a formal fellowship.”

This year, about 1,500 ob.gyn. residents matched into 280 residency programs, according to the National Residency Matching Program.

Colwill_Alyssa_OR_web.jpg

Alyssa Colwill, MD, assistant professor of obstetrics and gynecology at Oregon Health and Science University and director of the ob.gyn. Ryan Residency Program at OHSU, estimated that 1,000 ob.gyn. residents per year will seek out-of-state abortion training. The estimate is based on the number of residents in programs in states with restrictions.

The Ryan Program, which began in 1999, helps ob.gyn. residency programs provide training in abortion and contraception care (family planning) as a required rotation.
 

Connecting programs

Ryan-affiliated residencies have been helping connect programs in states with abortion bans and restrictions to programs in states with more liberal laws.

Twelve of the 100 Ryan programs sent residents out of state in the past academic year, and 15 will follow this year. More are expected soon, said Kristin Simonson, MA, director of programs and operations at the Ryan Residency Program, headquartered at the Bixby Center for Global Reproductive Health at the University of California, San Francisco.

Before the Dobbs decision, very few programs considered next steps to train ob.gyn. residents if abortions became illegal, Ms. Simonson said. “I think a lot of people just kind of were waiting and seeing ... and hoping that they wouldn’t have to make any drastic plans. It was hard to motivate people to have a plan B ready to go,” she said.

“Almost all of us working in this field had a really bad feeling,” said Courtney G. Forbis, MD, UNM assistant professor of ob.gyn. and Ryan Residency director. She and colleagues began planning for the future months ahead of the court decision. But the program wasn’t able to begin accepting out-of-state residents until now, she said. “We are trying to use this experience to see what we can accommodate in the future.”

OHSU also began planning for alternative training when it learned of the leaked Supreme Court decision, Dr. Colwill said. “We decided that we had the bandwidth and opportunity to train more individuals that were going to lose access to services and educational opportunities,” she said.

The university ran a 4-week test rotation last fall. So far, six residents and one fellow have come from out of the state, said Dr. Colwill. OHSU hopes to have 10 more in the coming year. The out-of-state learners will join 32 ob.gyn. residents and 12 fellows who were already in the program, she said.

To ease residents’ integration into an away program, the Ryan Program – along with the American College of Obstetricians and Gynecologists, the Council on Resident Education in Obstetrics and Gynecology, and Innovating Education in Reproductive Health – recently began offering a free, web-based patient-centered abortion education curriculum.

Connolly_AnnaMarie_DC_web.jpg

The course supplements in-person clinical training in abortion care and prepares residents traveling and transitioning into another program to begin learning new skills on their first day, AnnaMarie Connolly, MD, ACOG’s chief of education and academic affairs, said in a prepared statement.
 

Training costs

Residents and their institutions also face additional costs. The home institution that loses a resident for a few weeks to a month has to determine how to cover the care not provided while they are away, Ms. Simonson said. Residents may incur expenses for transportation, housing, food, and other things while out of state.

OHSU covers transportation and housing through its abortion care and training fund, but there are other factors to consider, Dr. Colwill said. For example, the home and host programs have to coordinate licensing, malpractice, and line up rotation dates, she said.

Among other complications, UNM wasn’t able to set up an agreement so that its new resident could participate in a rotation at Planned Parenthood. “We have the clinical volume to accommodate another learner,” Dr. Forbis said. But the program has to balance resources, such as “trying to make sure we don’t have one faculty [member] assigned to too many learners at one time,” she said.

Given the logistic and financial challenges, programs may not be able to ensure that all residents who need abortion training receive it, said Ms. Simonson.

The Ryan Program, for instance, can’t help the more than 100 residency programs in states where abortions are currently illegal, she said.

UNM is trying to partner with specific programs, such as those in the state of Texas where abortion is banned, to train its residents each year, Dr. Forbis said.

OHSU also will look for opportunities to train as many residents as possible, Dr. Colwill said, “but I don’t think we’ll ever be able to fill that gap of 1,000 residents that need this training.”

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

By the end of August 2022, overall use of mental health services was almost 40% higher than before the COVID-19 pandemic, while spending increased by 54%, according to a new study by researchers at the RAND Corporation.

During the early phase of the pandemic, from mid-March to mid-December 2020, before the vaccine was available, in-person visits decreased by 40%, while telehealth visits increased by 1,000%, reported Jonathan H. Cantor, PhD, and colleagues at RAND, and at Castlight Health, a benefit coordination provider, in a paper published online in JAMA Health Forum.

Between December 2020 and August 2022, telehealth visits stayed stable, but in-person visits creeped back up, eventually reaching 80% of prepandemic levels. However, “total utilization was higher than before the pandemic,” Dr. Cantor, a policy researcher at RAND, told this news organization. 

“It could be that it’s easier for individuals to receive care via telehealth, but it could also just be that there’s a greater demand or need since the pandemic,” said Dr. Cantor. “We’ll just need more research to actually unpack what’s going on,” he said.

Initial per capita spending increased by about a third and was up overall by more than half. But it’s not clear how much of that is due to utilization or to price of services, said Dr. Cantor. Spending for telehealth services remained stable in the post-vaccine period, while spending on in-person visits returned to prepandemic levels.

Dr. Cantor and his colleagues were not able to determine whether utilization was by new or existing patients, but he said that would be good data to have. “It would be really important to know whether or not folks are initiating care because telehealth is making it easier,” he said.

The authors analyzed about 1.5 million claims for anxiety disorders, major depressive disorder, bipolar disorder, schizophrenia, and posttraumatic stress disorder, out of claims submitted by 7 million commercially insured adults whose self-insured employers used the Castlight benefit.

Dr. Cantor noted that this is just a small subset of the U.S. population. He said he’d like to have data from Medicare and Medicaid to fully assess the impact of the COVID-19 pandemic on mental health and of telehealth visits.

“This is a still-burgeoning field,” he said about telehealth. “We’re still trying to get a handle on how things are operating, given that there’s been so much change so rapidly.”

Meanwhile, 152 major employers responding to a large national survey this summer said that they’ve been grappling with how COVID-19 has affected workers. The employers include 72 Fortune 100 companies and provide health coverage for more than 60 million workers, retirees, and their families.

Seventy-seven percent said they are currently seeing an increase in depression, anxiety, and substance use disorders as a result of the pandemic, according to the Business Group on Health’s survey. That’s up from 44% in 2022.

Going forward, employers will focus on increasing access to mental health services, the survey reported.

“Our survey found that in 2024 and for the near future, employers will be acutely focused on addressing employees’ mental health needs while ensuring access and lowering cost barriers,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.

The study was supported by grants from the National Institute of Mental Health and the National Institute on Aging. Coauthor Dena Bravata, MD, a Castlight employee, reported receiving personal fees from Castlight Health during the conduct of the study. Coauthor Christopher M. Whaley, a RAND employee, reported receiving personal fees from Castlight Health outside the submitted work.

A version of this article appeared on Medscape.com.

By the end of August 2022, overall use of mental health services was almost 40% higher than before the COVID-19 pandemic, while spending increased by 54%, according to a new study by researchers at the RAND Corporation.

During the early phase of the pandemic, from mid-March to mid-December 2020, before the vaccine was available, in-person visits decreased by 40%, while telehealth visits increased by 1,000%, reported Jonathan H. Cantor, PhD, and colleagues at RAND, and at Castlight Health, a benefit coordination provider, in a paper published online in JAMA Health Forum.

Between December 2020 and August 2022, telehealth visits stayed stable, but in-person visits creeped back up, eventually reaching 80% of prepandemic levels. However, “total utilization was higher than before the pandemic,” Dr. Cantor, a policy researcher at RAND, told this news organization. 

“It could be that it’s easier for individuals to receive care via telehealth, but it could also just be that there’s a greater demand or need since the pandemic,” said Dr. Cantor. “We’ll just need more research to actually unpack what’s going on,” he said.

Initial per capita spending increased by about a third and was up overall by more than half. But it’s not clear how much of that is due to utilization or to price of services, said Dr. Cantor. Spending for telehealth services remained stable in the post-vaccine period, while spending on in-person visits returned to prepandemic levels.

Dr. Cantor and his colleagues were not able to determine whether utilization was by new or existing patients, but he said that would be good data to have. “It would be really important to know whether or not folks are initiating care because telehealth is making it easier,” he said.

The authors analyzed about 1.5 million claims for anxiety disorders, major depressive disorder, bipolar disorder, schizophrenia, and posttraumatic stress disorder, out of claims submitted by 7 million commercially insured adults whose self-insured employers used the Castlight benefit.

Dr. Cantor noted that this is just a small subset of the U.S. population. He said he’d like to have data from Medicare and Medicaid to fully assess the impact of the COVID-19 pandemic on mental health and of telehealth visits.

“This is a still-burgeoning field,” he said about telehealth. “We’re still trying to get a handle on how things are operating, given that there’s been so much change so rapidly.”

Meanwhile, 152 major employers responding to a large national survey this summer said that they’ve been grappling with how COVID-19 has affected workers. The employers include 72 Fortune 100 companies and provide health coverage for more than 60 million workers, retirees, and their families.

Seventy-seven percent said they are currently seeing an increase in depression, anxiety, and substance use disorders as a result of the pandemic, according to the Business Group on Health’s survey. That’s up from 44% in 2022.

Going forward, employers will focus on increasing access to mental health services, the survey reported.

“Our survey found that in 2024 and for the near future, employers will be acutely focused on addressing employees’ mental health needs while ensuring access and lowering cost barriers,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.

The study was supported by grants from the National Institute of Mental Health and the National Institute on Aging. Coauthor Dena Bravata, MD, a Castlight employee, reported receiving personal fees from Castlight Health during the conduct of the study. Coauthor Christopher M. Whaley, a RAND employee, reported receiving personal fees from Castlight Health outside the submitted work.

A version of this article appeared on Medscape.com.

By the end of August 2022, overall use of mental health services was almost 40% higher than before the COVID-19 pandemic, while spending increased by 54%, according to a new study by researchers at the RAND Corporation.

During the early phase of the pandemic, from mid-March to mid-December 2020, before the vaccine was available, in-person visits decreased by 40%, while telehealth visits increased by 1,000%, reported Jonathan H. Cantor, PhD, and colleagues at RAND, and at Castlight Health, a benefit coordination provider, in a paper published online in JAMA Health Forum.

Between December 2020 and August 2022, telehealth visits stayed stable, but in-person visits creeped back up, eventually reaching 80% of prepandemic levels. However, “total utilization was higher than before the pandemic,” Dr. Cantor, a policy researcher at RAND, told this news organization. 

“It could be that it’s easier for individuals to receive care via telehealth, but it could also just be that there’s a greater demand or need since the pandemic,” said Dr. Cantor. “We’ll just need more research to actually unpack what’s going on,” he said.

Initial per capita spending increased by about a third and was up overall by more than half. But it’s not clear how much of that is due to utilization or to price of services, said Dr. Cantor. Spending for telehealth services remained stable in the post-vaccine period, while spending on in-person visits returned to prepandemic levels.

Dr. Cantor and his colleagues were not able to determine whether utilization was by new or existing patients, but he said that would be good data to have. “It would be really important to know whether or not folks are initiating care because telehealth is making it easier,” he said.

The authors analyzed about 1.5 million claims for anxiety disorders, major depressive disorder, bipolar disorder, schizophrenia, and posttraumatic stress disorder, out of claims submitted by 7 million commercially insured adults whose self-insured employers used the Castlight benefit.

Dr. Cantor noted that this is just a small subset of the U.S. population. He said he’d like to have data from Medicare and Medicaid to fully assess the impact of the COVID-19 pandemic on mental health and of telehealth visits.

“This is a still-burgeoning field,” he said about telehealth. “We’re still trying to get a handle on how things are operating, given that there’s been so much change so rapidly.”

Meanwhile, 152 major employers responding to a large national survey this summer said that they’ve been grappling with how COVID-19 has affected workers. The employers include 72 Fortune 100 companies and provide health coverage for more than 60 million workers, retirees, and their families.

Seventy-seven percent said they are currently seeing an increase in depression, anxiety, and substance use disorders as a result of the pandemic, according to the Business Group on Health’s survey. That’s up from 44% in 2022.

Going forward, employers will focus on increasing access to mental health services, the survey reported.

“Our survey found that in 2024 and for the near future, employers will be acutely focused on addressing employees’ mental health needs while ensuring access and lowering cost barriers,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.

The study was supported by grants from the National Institute of Mental Health and the National Institute on Aging. Coauthor Dena Bravata, MD, a Castlight employee, reported receiving personal fees from Castlight Health during the conduct of the study. Coauthor Christopher M. Whaley, a RAND employee, reported receiving personal fees from Castlight Health outside the submitted work.

A version of this article appeared on Medscape.com.

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

Under a new Medicare pilot program that will begin in 2024, the federal government will pay clinicians to coordinate at-home dementia support services, including respite care for family members.

A Department of Health & Human Services initiative, part of the aim of the Guiding an Improved Dementia Experience (GUIDE) program is to help Medicare beneficiaries with dementia stay in the community for as long as possible. It is estimated that there are 6.7 million Americans living with Alzheimer’s disease or some other form of dementia, said HHS.

The program is voluntary and will be open to Medicare-enrolled clinicians and other providers who can assemble an interdisciplinary care team and meet the program’s participation criteria.

“Our new GUIDE Model has the potential to improve the quality of life for people with dementia and alleviate the significant strain on our families,” said HHS Secretary Xavier Becerra, in a statement.

“Not only is dementia care management a proven way to improve the quality of care and quality of life for those living with Alzheimer’s and other dementia, but now we know that it would also save the federal government billions of dollars,” Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director, said in a statement.

Mr. Egge cited a recent analysis commissioned by AIM that found that dementia care management would save the federal government nearly $21 billion over 10 years.

“People living with dementia and their caregivers too often struggle to manage their health care and connect with key supports that can allow them to remain in their homes and communities,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, in the HHS statement.

“Fragmented care contributes to the mental and physical health strain of caring for someone with dementia, as well as the substantial financial burden,” she said, adding that Black, Hispanic, Asian American, Native Hawaiian, and Pacific Islander populations have been especially disadvantaged.

The GUIDE Model will provide new resources and greater access to specialty care to those communities, said Ms. Brooks-LaSure.

Care teams that seek to participate in the GUIDE model must have a care navigator who has received required training in dementia, assessment, and care planning.

The teams also must have a clinician with dementia proficiency as recognized by experience caring for adults with cognitive impairment; experience caring for patients aged 65 years old or older; or specialty designation in neurology, psychiatry, geriatrics, geriatric psychiatry, behavioral neurology, or geriatric neurology.

Medicare beneficiaries will be eligible if they are not residing in a nursing home; are not enrolled in hospice; and have a confirmed dementia diagnosis.

Beneficiaries who receive care from GUIDE participants will be placed in one of five “tiers,” based on a combination of disease stage and caregiver status. Beneficiary needs, and care intensity and payment, increase by tier.

GUIDE teams will receive a monthly, per-beneficiary amount for providing care management and coordination and caregiver education and support services. They can also bill for respite services – up to an annual cap – for Medicare beneficiaries who have an unpaid caregiver.

Clinicians seeking to participate in GUIDE can apply beginning in the fall. The program will run for 8 years beginning July 1, 2024.

Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in a statement that the organization had “advocated for this approach for years, believing it [to be] the key to addressing systemic challenges faced by those with dementia, their families and those who provide them with care and support.”

The John A. Hartford Foundation noted that it also had long pushed for a comprehensive dementia care program. “Comprehensive dementia care supports both the medical and nonmedical needs of patients and their family caregivers,” said Foundation President Terry Fulmer, PhD, RN, FAAN, in a statement.

“Notably and necessarily, the model will help improve equity in access to care for underserved communities by addressing unpaid caregiver needs, including respite services and screening for health-related social needs,” added Dr. Fulmer.

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

Under a new Medicare pilot program that will begin in 2024, the federal government will pay clinicians to coordinate at-home dementia support services, including respite care for family members.

A Department of Health & Human Services initiative, part of the aim of the Guiding an Improved Dementia Experience (GUIDE) program is to help Medicare beneficiaries with dementia stay in the community for as long as possible. It is estimated that there are 6.7 million Americans living with Alzheimer’s disease or some other form of dementia, said HHS.

The program is voluntary and will be open to Medicare-enrolled clinicians and other providers who can assemble an interdisciplinary care team and meet the program’s participation criteria.

“Our new GUIDE Model has the potential to improve the quality of life for people with dementia and alleviate the significant strain on our families,” said HHS Secretary Xavier Becerra, in a statement.

“Not only is dementia care management a proven way to improve the quality of care and quality of life for those living with Alzheimer’s and other dementia, but now we know that it would also save the federal government billions of dollars,” Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director, said in a statement.

Mr. Egge cited a recent analysis commissioned by AIM that found that dementia care management would save the federal government nearly $21 billion over 10 years.

“People living with dementia and their caregivers too often struggle to manage their health care and connect with key supports that can allow them to remain in their homes and communities,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, in the HHS statement.

“Fragmented care contributes to the mental and physical health strain of caring for someone with dementia, as well as the substantial financial burden,” she said, adding that Black, Hispanic, Asian American, Native Hawaiian, and Pacific Islander populations have been especially disadvantaged.

The GUIDE Model will provide new resources and greater access to specialty care to those communities, said Ms. Brooks-LaSure.

Care teams that seek to participate in the GUIDE model must have a care navigator who has received required training in dementia, assessment, and care planning.

The teams also must have a clinician with dementia proficiency as recognized by experience caring for adults with cognitive impairment; experience caring for patients aged 65 years old or older; or specialty designation in neurology, psychiatry, geriatrics, geriatric psychiatry, behavioral neurology, or geriatric neurology.

Medicare beneficiaries will be eligible if they are not residing in a nursing home; are not enrolled in hospice; and have a confirmed dementia diagnosis.

Beneficiaries who receive care from GUIDE participants will be placed in one of five “tiers,” based on a combination of disease stage and caregiver status. Beneficiary needs, and care intensity and payment, increase by tier.

GUIDE teams will receive a monthly, per-beneficiary amount for providing care management and coordination and caregiver education and support services. They can also bill for respite services – up to an annual cap – for Medicare beneficiaries who have an unpaid caregiver.

Clinicians seeking to participate in GUIDE can apply beginning in the fall. The program will run for 8 years beginning July 1, 2024.

Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in a statement that the organization had “advocated for this approach for years, believing it [to be] the key to addressing systemic challenges faced by those with dementia, their families and those who provide them with care and support.”

The John A. Hartford Foundation noted that it also had long pushed for a comprehensive dementia care program. “Comprehensive dementia care supports both the medical and nonmedical needs of patients and their family caregivers,” said Foundation President Terry Fulmer, PhD, RN, FAAN, in a statement.

“Notably and necessarily, the model will help improve equity in access to care for underserved communities by addressing unpaid caregiver needs, including respite services and screening for health-related social needs,” added Dr. Fulmer.

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

Under a new Medicare pilot program that will begin in 2024, the federal government will pay clinicians to coordinate at-home dementia support services, including respite care for family members.

A Department of Health & Human Services initiative, part of the aim of the Guiding an Improved Dementia Experience (GUIDE) program is to help Medicare beneficiaries with dementia stay in the community for as long as possible. It is estimated that there are 6.7 million Americans living with Alzheimer’s disease or some other form of dementia, said HHS.

The program is voluntary and will be open to Medicare-enrolled clinicians and other providers who can assemble an interdisciplinary care team and meet the program’s participation criteria.

“Our new GUIDE Model has the potential to improve the quality of life for people with dementia and alleviate the significant strain on our families,” said HHS Secretary Xavier Becerra, in a statement.

“Not only is dementia care management a proven way to improve the quality of care and quality of life for those living with Alzheimer’s and other dementia, but now we know that it would also save the federal government billions of dollars,” Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director, said in a statement.

Mr. Egge cited a recent analysis commissioned by AIM that found that dementia care management would save the federal government nearly $21 billion over 10 years.

“People living with dementia and their caregivers too often struggle to manage their health care and connect with key supports that can allow them to remain in their homes and communities,” said Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, in the HHS statement.

“Fragmented care contributes to the mental and physical health strain of caring for someone with dementia, as well as the substantial financial burden,” she said, adding that Black, Hispanic, Asian American, Native Hawaiian, and Pacific Islander populations have been especially disadvantaged.

The GUIDE Model will provide new resources and greater access to specialty care to those communities, said Ms. Brooks-LaSure.

Care teams that seek to participate in the GUIDE model must have a care navigator who has received required training in dementia, assessment, and care planning.

The teams also must have a clinician with dementia proficiency as recognized by experience caring for adults with cognitive impairment; experience caring for patients aged 65 years old or older; or specialty designation in neurology, psychiatry, geriatrics, geriatric psychiatry, behavioral neurology, or geriatric neurology.

Medicare beneficiaries will be eligible if they are not residing in a nursing home; are not enrolled in hospice; and have a confirmed dementia diagnosis.

Beneficiaries who receive care from GUIDE participants will be placed in one of five “tiers,” based on a combination of disease stage and caregiver status. Beneficiary needs, and care intensity and payment, increase by tier.

GUIDE teams will receive a monthly, per-beneficiary amount for providing care management and coordination and caregiver education and support services. They can also bill for respite services – up to an annual cap – for Medicare beneficiaries who have an unpaid caregiver.

Clinicians seeking to participate in GUIDE can apply beginning in the fall. The program will run for 8 years beginning July 1, 2024.

Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in a statement that the organization had “advocated for this approach for years, believing it [to be] the key to addressing systemic challenges faced by those with dementia, their families and those who provide them with care and support.”

The John A. Hartford Foundation noted that it also had long pushed for a comprehensive dementia care program. “Comprehensive dementia care supports both the medical and nonmedical needs of patients and their family caregivers,” said Foundation President Terry Fulmer, PhD, RN, FAAN, in a statement.

“Notably and necessarily, the model will help improve equity in access to care for underserved communities by addressing unpaid caregiver needs, including respite services and screening for health-related social needs,” added Dr. Fulmer.

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

The former owner of a South Florida nursing school at the heart of a federal investigation into a multistate fraud scheme awarding at least 7,600 fake diplomas will have to serve nearly 2 years and repay millions.

U.S. District Judge Rodney Smith of the Southern District of Florida in Fort Lauderdale recently sentenced Johanah Napoleon, former president of the Palm Beach School of Nursing, to 21 months in prison, according to the Miami Herald . The judge also ordered Ms. Napoleon to pay about $3.5 million. She already paid $2.6 million of it, the Herald reports.

The sentence is “indicative of the seriousness of this crime,” shared Willa Fuller, BSN, RN, executive director of the Florida Nurses Association. “Hopefully, this decision will deter potential perpetrators in the future,” Ms. Fuller said in an email.

Ms. Napoleon was charged in 2021 along with two owners of nursing schools in Maryland and Virginia who worked with her. All pled guilty to selling fake degrees for $6,000-$18,000. The Florida Board of Nursing had previously shut down the Palm Beach school in 2017 as a result of its students’ low passing rate on the national licensing exam.

A tip related to the Maryland case led to federal charges in January against 25 owners, operators, and employees of the Palm Beach School of Nursing and two other Florida nursing schools for selling thousands of fake nursing degrees. Those who were charged operated in Delaware, New York, New Jersey, Texas, and Florida.

Five of those 25 defendants will be sentenced on July 27 in a federal district court in Fort Lauderdale after pleading guilty in May to wire fraud conspiracy, according to the U.S. Attorney for the Southern District of Florida. They each face up to 20 years in federal prison.

Purchasers of the fake associate or bachelor’s degrees received transcripts showing that they completed coursework. Some 2,800 of the buyers passed the national nursing licensing exam to become registered nurses and licensed practice nurses/vocational nurses in hospitals, nursing homes, and Veterans Affairs medical centers around the country, according to The New York Times.

Ms. Napoleon’s attorney, Joel DeFabio, said in an interview that he requested a lower sentence than the 4 years recommended in sentencing guidelines because Ms. Napoleon pled guilty quickly and cooperated with the federal investigation.

Mr. DeFabio said that Ms. Napoleon will appear as the government’s witness in a trial in November against Gail Russ, who is one defendant, along with 13 others in the case involving the Palm Beach School of Nursing.

Meanwhile, state nursing boards have been trying to locate nurses who received the fake degrees. In March, the New York nursing board told 903 nurses to either surrender their licenses or prove they had the appropriate education. The board estimated that another 2,300 licensees from the Florida schools had pending applications.

Some nurses who received fake diplomas are pushing back. Attorneys for nurses in Georgia and Pennsylvania claim that their clients were either victims or in some cases, have legitimate credentials.

“The quality of nursing education as well as protection of applicants from these harmful schemes is essential to maintaining the strict standards of the nursing profession,” Ms. Fuller said.

A version of this article appeared on Medscape.com.

The former owner of a South Florida nursing school at the heart of a federal investigation into a multistate fraud scheme awarding at least 7,600 fake diplomas will have to serve nearly 2 years and repay millions.

U.S. District Judge Rodney Smith of the Southern District of Florida in Fort Lauderdale recently sentenced Johanah Napoleon, former president of the Palm Beach School of Nursing, to 21 months in prison, according to the Miami Herald . The judge also ordered Ms. Napoleon to pay about $3.5 million. She already paid $2.6 million of it, the Herald reports.

The sentence is “indicative of the seriousness of this crime,” shared Willa Fuller, BSN, RN, executive director of the Florida Nurses Association. “Hopefully, this decision will deter potential perpetrators in the future,” Ms. Fuller said in an email.

Ms. Napoleon was charged in 2021 along with two owners of nursing schools in Maryland and Virginia who worked with her. All pled guilty to selling fake degrees for $6,000-$18,000. The Florida Board of Nursing had previously shut down the Palm Beach school in 2017 as a result of its students’ low passing rate on the national licensing exam.

A tip related to the Maryland case led to federal charges in January against 25 owners, operators, and employees of the Palm Beach School of Nursing and two other Florida nursing schools for selling thousands of fake nursing degrees. Those who were charged operated in Delaware, New York, New Jersey, Texas, and Florida.

Five of those 25 defendants will be sentenced on July 27 in a federal district court in Fort Lauderdale after pleading guilty in May to wire fraud conspiracy, according to the U.S. Attorney for the Southern District of Florida. They each face up to 20 years in federal prison.

Purchasers of the fake associate or bachelor’s degrees received transcripts showing that they completed coursework. Some 2,800 of the buyers passed the national nursing licensing exam to become registered nurses and licensed practice nurses/vocational nurses in hospitals, nursing homes, and Veterans Affairs medical centers around the country, according to The New York Times.

Ms. Napoleon’s attorney, Joel DeFabio, said in an interview that he requested a lower sentence than the 4 years recommended in sentencing guidelines because Ms. Napoleon pled guilty quickly and cooperated with the federal investigation.

Mr. DeFabio said that Ms. Napoleon will appear as the government’s witness in a trial in November against Gail Russ, who is one defendant, along with 13 others in the case involving the Palm Beach School of Nursing.

Meanwhile, state nursing boards have been trying to locate nurses who received the fake degrees. In March, the New York nursing board told 903 nurses to either surrender their licenses or prove they had the appropriate education. The board estimated that another 2,300 licensees from the Florida schools had pending applications.

Some nurses who received fake diplomas are pushing back. Attorneys for nurses in Georgia and Pennsylvania claim that their clients were either victims or in some cases, have legitimate credentials.

“The quality of nursing education as well as protection of applicants from these harmful schemes is essential to maintaining the strict standards of the nursing profession,” Ms. Fuller said.

A version of this article appeared on Medscape.com.

The former owner of a South Florida nursing school at the heart of a federal investigation into a multistate fraud scheme awarding at least 7,600 fake diplomas will have to serve nearly 2 years and repay millions.

U.S. District Judge Rodney Smith of the Southern District of Florida in Fort Lauderdale recently sentenced Johanah Napoleon, former president of the Palm Beach School of Nursing, to 21 months in prison, according to the Miami Herald . The judge also ordered Ms. Napoleon to pay about $3.5 million. She already paid $2.6 million of it, the Herald reports.

The sentence is “indicative of the seriousness of this crime,” shared Willa Fuller, BSN, RN, executive director of the Florida Nurses Association. “Hopefully, this decision will deter potential perpetrators in the future,” Ms. Fuller said in an email.

Ms. Napoleon was charged in 2021 along with two owners of nursing schools in Maryland and Virginia who worked with her. All pled guilty to selling fake degrees for $6,000-$18,000. The Florida Board of Nursing had previously shut down the Palm Beach school in 2017 as a result of its students’ low passing rate on the national licensing exam.

A tip related to the Maryland case led to federal charges in January against 25 owners, operators, and employees of the Palm Beach School of Nursing and two other Florida nursing schools for selling thousands of fake nursing degrees. Those who were charged operated in Delaware, New York, New Jersey, Texas, and Florida.

Five of those 25 defendants will be sentenced on July 27 in a federal district court in Fort Lauderdale after pleading guilty in May to wire fraud conspiracy, according to the U.S. Attorney for the Southern District of Florida. They each face up to 20 years in federal prison.

Purchasers of the fake associate or bachelor’s degrees received transcripts showing that they completed coursework. Some 2,800 of the buyers passed the national nursing licensing exam to become registered nurses and licensed practice nurses/vocational nurses in hospitals, nursing homes, and Veterans Affairs medical centers around the country, according to The New York Times.

Ms. Napoleon’s attorney, Joel DeFabio, said in an interview that he requested a lower sentence than the 4 years recommended in sentencing guidelines because Ms. Napoleon pled guilty quickly and cooperated with the federal investigation.

Mr. DeFabio said that Ms. Napoleon will appear as the government’s witness in a trial in November against Gail Russ, who is one defendant, along with 13 others in the case involving the Palm Beach School of Nursing.

Meanwhile, state nursing boards have been trying to locate nurses who received the fake degrees. In March, the New York nursing board told 903 nurses to either surrender their licenses or prove they had the appropriate education. The board estimated that another 2,300 licensees from the Florida schools had pending applications.

Some nurses who received fake diplomas are pushing back. Attorneys for nurses in Georgia and Pennsylvania claim that their clients were either victims or in some cases, have legitimate credentials.

“The quality of nursing education as well as protection of applicants from these harmful schemes is essential to maintaining the strict standards of the nursing profession,” Ms. Fuller said.

A version of this article appeared on Medscape.com.