MDedge Pediatrics

One gene and pathogenic missense variants in that gene account for most cases of uncombable hair syndrome (UHS), a rare hair shaft anomaly that manifests during infancy, investigators have reported.

The findings are from a cohort study published in JAMA Dermatology, which involved 107 unrelated children and adults suspected of having UHS, as well as family members, all of whom were recruited from January 2013 to December 2021. Genetic analyses were conducted in Germany from January 2014 to December 2021 with exome sequencing.
 

Study builds on prior research

Senior author Regina C. Betz, MD, professor of dermatogenetics at the Institute of Human Genetics, University Hospital Bonn, Germany, said that in 2016, she and her coinvestigators authored a study on the molecular genetics of UHS. That study, which involved 18 people with UHS, identified variants in three genes – PADI3, TCHH, and TGM3 – that encode proteins that play a role in the formation of the hair shaft. The investigators described how a deficiency in the shaping and mechanical strengthening of the hair shaft occurs in the UHS phenotype, which is characterized by dry, frizzy, and wiry hair that cannot be combed flat.

As a result of that previous work, “we base the assignment or confirmation of a clinical diagnosis of UHS on molecular genetic diagnostics,” the authors write in the new study, rather than on the clinical appearance of the hair and the physical examination of the patient, with confirmation on microscopical examination of the hair shaft.
 

Social media as instrument in finding study participants

Following the 2016 study, Dr. Betz and colleagues were contacted by many clinicians and by the public through Facebook and other social media platforms with details about possible cases of UHS, an autosomal recessive disorder. Through these contacts, blood samples, saliva, or DNA was sent to the investigators’ laboratory from 89 unrelated index patients (69 female patients, 20 male patients) suspected of having UHS. This resulted in the identification of pathogenic variants in 69 cases, the investigators write.

“In the first study, we had 18 patients, and then we tried to collect as many as possible” to determine the main mechanism behind UHS, Dr. Betz said. One question is whether there are additional genes responsible for UHS, she noted. “Even now, we are not sure, because in 25% [of cases in the new study], we didn’t find any mutation in the three known genes.”

The current study resulted in the discovery of eight novel pathogenic variants in PADI3, which are responsible for 71.0% (76) of the 107 cases. Of those, “6 were single observations and 2 were observed in 3 and 2 individuals, respectively,” the investigators write.

Children can grow out of this disorder, but it can also persist into adulthood, Dr. Betz noted. Communication that investigators had with parents of the children with UHS revealed that these children are often the targets of bullying by other children, she added.

She and her and colleagues will continue this research and are currently studying adults who have UHS.
 

Research leads to possible treatment pathways

Jeff Donovan, MD, FRCPC, FAAD, a dermatologist and medical director of the Donovan Hair Clinic in Whistler, British Columbia, described these findings as fundamental to understanding UHS and creating pathways to possible treatments.

The study “identifies more about the genetic basis of this challenging condition,” said Dr. Donovan, who is also clinical instructor in the department of dermatology at the University of British Columbia, Vancouver, and president of the Canadian Hair Loss Foundation. “We really need this type of information in order to have any sort of clue in terms of how to treat it,” he told this news organization.

“In the hair loss world, it’s pretty clear that if you can understand the genetic basis of things, or the basic science of a condition, whether it’s the basic genetics or the basic immunology, you give yourself the best chance to develop good treatments,” said Dr. Donovan.

The article provides advanced genetic information of the condition, such that geneticists can test for at least three markers if they are suspecting UHS, Dr. Donovan observed.
 

Condition can lead to bullying

Dr. Donovan also commented that UHS can have a detrimental impact on children with regard to socializing with their peers. “Having hair that sticks out and is very full like this is challenging because kids do get teased,” he said.

“It is often the parents who are the most affected” when a child aged 2-5 years has a hair condition such as UHS. But at age 5-9, “children are developing self-identity and an understanding of various aspects of self-esteem and what they look like and what others look like. And that’s where the teasing really starts. And that’s where it does become troublesome.”

Dr. Betz and Dr. Donovan have disclosed no relevant financial relationships.

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

One gene and pathogenic missense variants in that gene account for most cases of uncombable hair syndrome (UHS), a rare hair shaft anomaly that manifests during infancy, investigators have reported.

The findings are from a cohort study published in JAMA Dermatology, which involved 107 unrelated children and adults suspected of having UHS, as well as family members, all of whom were recruited from January 2013 to December 2021. Genetic analyses were conducted in Germany from January 2014 to December 2021 with exome sequencing.
 

Study builds on prior research

Senior author Regina C. Betz, MD, professor of dermatogenetics at the Institute of Human Genetics, University Hospital Bonn, Germany, said that in 2016, she and her coinvestigators authored a study on the molecular genetics of UHS. That study, which involved 18 people with UHS, identified variants in three genes – PADI3, TCHH, and TGM3 – that encode proteins that play a role in the formation of the hair shaft. The investigators described how a deficiency in the shaping and mechanical strengthening of the hair shaft occurs in the UHS phenotype, which is characterized by dry, frizzy, and wiry hair that cannot be combed flat.

As a result of that previous work, “we base the assignment or confirmation of a clinical diagnosis of UHS on molecular genetic diagnostics,” the authors write in the new study, rather than on the clinical appearance of the hair and the physical examination of the patient, with confirmation on microscopical examination of the hair shaft.
 

Social media as instrument in finding study participants

Following the 2016 study, Dr. Betz and colleagues were contacted by many clinicians and by the public through Facebook and other social media platforms with details about possible cases of UHS, an autosomal recessive disorder. Through these contacts, blood samples, saliva, or DNA was sent to the investigators’ laboratory from 89 unrelated index patients (69 female patients, 20 male patients) suspected of having UHS. This resulted in the identification of pathogenic variants in 69 cases, the investigators write.

“In the first study, we had 18 patients, and then we tried to collect as many as possible” to determine the main mechanism behind UHS, Dr. Betz said. One question is whether there are additional genes responsible for UHS, she noted. “Even now, we are not sure, because in 25% [of cases in the new study], we didn’t find any mutation in the three known genes.”

The current study resulted in the discovery of eight novel pathogenic variants in PADI3, which are responsible for 71.0% (76) of the 107 cases. Of those, “6 were single observations and 2 were observed in 3 and 2 individuals, respectively,” the investigators write.

Children can grow out of this disorder, but it can also persist into adulthood, Dr. Betz noted. Communication that investigators had with parents of the children with UHS revealed that these children are often the targets of bullying by other children, she added.

She and her and colleagues will continue this research and are currently studying adults who have UHS.
 

Research leads to possible treatment pathways

Jeff Donovan, MD, FRCPC, FAAD, a dermatologist and medical director of the Donovan Hair Clinic in Whistler, British Columbia, described these findings as fundamental to understanding UHS and creating pathways to possible treatments.

The study “identifies more about the genetic basis of this challenging condition,” said Dr. Donovan, who is also clinical instructor in the department of dermatology at the University of British Columbia, Vancouver, and president of the Canadian Hair Loss Foundation. “We really need this type of information in order to have any sort of clue in terms of how to treat it,” he told this news organization.

“In the hair loss world, it’s pretty clear that if you can understand the genetic basis of things, or the basic science of a condition, whether it’s the basic genetics or the basic immunology, you give yourself the best chance to develop good treatments,” said Dr. Donovan.

The article provides advanced genetic information of the condition, such that geneticists can test for at least three markers if they are suspecting UHS, Dr. Donovan observed.
 

Condition can lead to bullying

Dr. Donovan also commented that UHS can have a detrimental impact on children with regard to socializing with their peers. “Having hair that sticks out and is very full like this is challenging because kids do get teased,” he said.

“It is often the parents who are the most affected” when a child aged 2-5 years has a hair condition such as UHS. But at age 5-9, “children are developing self-identity and an understanding of various aspects of self-esteem and what they look like and what others look like. And that’s where the teasing really starts. And that’s where it does become troublesome.”

Dr. Betz and Dr. Donovan have disclosed no relevant financial relationships.

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

One gene and pathogenic missense variants in that gene account for most cases of uncombable hair syndrome (UHS), a rare hair shaft anomaly that manifests during infancy, investigators have reported.

The findings are from a cohort study published in JAMA Dermatology, which involved 107 unrelated children and adults suspected of having UHS, as well as family members, all of whom were recruited from January 2013 to December 2021. Genetic analyses were conducted in Germany from January 2014 to December 2021 with exome sequencing.
 

Study builds on prior research

Senior author Regina C. Betz, MD, professor of dermatogenetics at the Institute of Human Genetics, University Hospital Bonn, Germany, said that in 2016, she and her coinvestigators authored a study on the molecular genetics of UHS. That study, which involved 18 people with UHS, identified variants in three genes – PADI3, TCHH, and TGM3 – that encode proteins that play a role in the formation of the hair shaft. The investigators described how a deficiency in the shaping and mechanical strengthening of the hair shaft occurs in the UHS phenotype, which is characterized by dry, frizzy, and wiry hair that cannot be combed flat.

As a result of that previous work, “we base the assignment or confirmation of a clinical diagnosis of UHS on molecular genetic diagnostics,” the authors write in the new study, rather than on the clinical appearance of the hair and the physical examination of the patient, with confirmation on microscopical examination of the hair shaft.
 

Social media as instrument in finding study participants

Following the 2016 study, Dr. Betz and colleagues were contacted by many clinicians and by the public through Facebook and other social media platforms with details about possible cases of UHS, an autosomal recessive disorder. Through these contacts, blood samples, saliva, or DNA was sent to the investigators’ laboratory from 89 unrelated index patients (69 female patients, 20 male patients) suspected of having UHS. This resulted in the identification of pathogenic variants in 69 cases, the investigators write.

“In the first study, we had 18 patients, and then we tried to collect as many as possible” to determine the main mechanism behind UHS, Dr. Betz said. One question is whether there are additional genes responsible for UHS, she noted. “Even now, we are not sure, because in 25% [of cases in the new study], we didn’t find any mutation in the three known genes.”

The current study resulted in the discovery of eight novel pathogenic variants in PADI3, which are responsible for 71.0% (76) of the 107 cases. Of those, “6 were single observations and 2 were observed in 3 and 2 individuals, respectively,” the investigators write.

Children can grow out of this disorder, but it can also persist into adulthood, Dr. Betz noted. Communication that investigators had with parents of the children with UHS revealed that these children are often the targets of bullying by other children, she added.

She and her and colleagues will continue this research and are currently studying adults who have UHS.
 

Research leads to possible treatment pathways

Jeff Donovan, MD, FRCPC, FAAD, a dermatologist and medical director of the Donovan Hair Clinic in Whistler, British Columbia, described these findings as fundamental to understanding UHS and creating pathways to possible treatments.

The study “identifies more about the genetic basis of this challenging condition,” said Dr. Donovan, who is also clinical instructor in the department of dermatology at the University of British Columbia, Vancouver, and president of the Canadian Hair Loss Foundation. “We really need this type of information in order to have any sort of clue in terms of how to treat it,” he told this news organization.

“In the hair loss world, it’s pretty clear that if you can understand the genetic basis of things, or the basic science of a condition, whether it’s the basic genetics or the basic immunology, you give yourself the best chance to develop good treatments,” said Dr. Donovan.

The article provides advanced genetic information of the condition, such that geneticists can test for at least three markers if they are suspecting UHS, Dr. Donovan observed.
 

Condition can lead to bullying

Dr. Donovan also commented that UHS can have a detrimental impact on children with regard to socializing with their peers. “Having hair that sticks out and is very full like this is challenging because kids do get teased,” he said.

“It is often the parents who are the most affected” when a child aged 2-5 years has a hair condition such as UHS. But at age 5-9, “children are developing self-identity and an understanding of various aspects of self-esteem and what they look like and what others look like. And that’s where the teasing really starts. And that’s where it does become troublesome.”

Dr. Betz and Dr. Donovan have disclosed no relevant financial relationships.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

Adderall, the attention-deficit/hyperactivity disorder medication, is in short supply in some parts of the nation, pharmacy chains and Adderall users say.

Half a dozen people told Bloomberg that pharmacies told them in August and September that the drug was out of stock. The patients were told the drug might not be available for weeks, though it’s supposed to be taken daily. BuzzFeed News said 20 people across the nation said that their pharmacies didn’t have Adderall in stock.

“It’s so frustrating that getting my meds requires me to be organized, focused, and motivated – all the things I’m on these meds to help with,” Irene Kelly, who has been using Adderall for 14 years, told BuzzFeed News.

Two pharmacy chains told Bloomberg that Adderall has not always been available to sell. Walgreens spokesperson Rebekah Pajak said there were “supply chain challenges” affecting instant-release and extended-release versions of the drug. CVS pharmacies can fill Adderall prescriptions “in most cases,” CVS spokesperson Matthew Blanchette said.

Several drugmakers have had brand-name and generic versions of Adderall on back order for months, Bloomberg reported. The problem started with a labor shortage at Teva Pharmaceutical, the top seller of Adderall in the United States, that created a limited supply of brand-name and generic instant-release Adderall, according to the outlet.

That said, the Food and Drug Administration is not reporting an Adderall shortage on its drug shortages database. The federal agency says it lists a drug as being in short supply when “overall market demand is not being met by the manufacturers of the product,” Bloomberg said.

“Manufacturers continue to release product,” FDA spokesperson Cherie Duvall-Jones said, according to Bloomberg.

Demand for Adderall is growing, possibly because of rising ADHD diagnoses that occurred during telehealth medical appointments amid the COVID-19 pandemic, Bloomberg reported, noting that some of those telehealth companies have come under scrutiny by the Drug Enforcement Administration and other government agencies.

NBC News, citing IQVIA, an analytics provider for the life sciences industry, reported that 41.4 million Adderall prescriptions were issued last year, up 10.4% from 2020.

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

Adderall, the attention-deficit/hyperactivity disorder medication, is in short supply in some parts of the nation, pharmacy chains and Adderall users say.

Half a dozen people told Bloomberg that pharmacies told them in August and September that the drug was out of stock. The patients were told the drug might not be available for weeks, though it’s supposed to be taken daily. BuzzFeed News said 20 people across the nation said that their pharmacies didn’t have Adderall in stock.

“It’s so frustrating that getting my meds requires me to be organized, focused, and motivated – all the things I’m on these meds to help with,” Irene Kelly, who has been using Adderall for 14 years, told BuzzFeed News.

Two pharmacy chains told Bloomberg that Adderall has not always been available to sell. Walgreens spokesperson Rebekah Pajak said there were “supply chain challenges” affecting instant-release and extended-release versions of the drug. CVS pharmacies can fill Adderall prescriptions “in most cases,” CVS spokesperson Matthew Blanchette said.

Several drugmakers have had brand-name and generic versions of Adderall on back order for months, Bloomberg reported. The problem started with a labor shortage at Teva Pharmaceutical, the top seller of Adderall in the United States, that created a limited supply of brand-name and generic instant-release Adderall, according to the outlet.

That said, the Food and Drug Administration is not reporting an Adderall shortage on its drug shortages database. The federal agency says it lists a drug as being in short supply when “overall market demand is not being met by the manufacturers of the product,” Bloomberg said.

“Manufacturers continue to release product,” FDA spokesperson Cherie Duvall-Jones said, according to Bloomberg.

Demand for Adderall is growing, possibly because of rising ADHD diagnoses that occurred during telehealth medical appointments amid the COVID-19 pandemic, Bloomberg reported, noting that some of those telehealth companies have come under scrutiny by the Drug Enforcement Administration and other government agencies.

NBC News, citing IQVIA, an analytics provider for the life sciences industry, reported that 41.4 million Adderall prescriptions were issued last year, up 10.4% from 2020.

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

Adderall, the attention-deficit/hyperactivity disorder medication, is in short supply in some parts of the nation, pharmacy chains and Adderall users say.

Half a dozen people told Bloomberg that pharmacies told them in August and September that the drug was out of stock. The patients were told the drug might not be available for weeks, though it’s supposed to be taken daily. BuzzFeed News said 20 people across the nation said that their pharmacies didn’t have Adderall in stock.

“It’s so frustrating that getting my meds requires me to be organized, focused, and motivated – all the things I’m on these meds to help with,” Irene Kelly, who has been using Adderall for 14 years, told BuzzFeed News.

Two pharmacy chains told Bloomberg that Adderall has not always been available to sell. Walgreens spokesperson Rebekah Pajak said there were “supply chain challenges” affecting instant-release and extended-release versions of the drug. CVS pharmacies can fill Adderall prescriptions “in most cases,” CVS spokesperson Matthew Blanchette said.

Several drugmakers have had brand-name and generic versions of Adderall on back order for months, Bloomberg reported. The problem started with a labor shortage at Teva Pharmaceutical, the top seller of Adderall in the United States, that created a limited supply of brand-name and generic instant-release Adderall, according to the outlet.

That said, the Food and Drug Administration is not reporting an Adderall shortage on its drug shortages database. The federal agency says it lists a drug as being in short supply when “overall market demand is not being met by the manufacturers of the product,” Bloomberg said.

“Manufacturers continue to release product,” FDA spokesperson Cherie Duvall-Jones said, according to Bloomberg.

Demand for Adderall is growing, possibly because of rising ADHD diagnoses that occurred during telehealth medical appointments amid the COVID-19 pandemic, Bloomberg reported, noting that some of those telehealth companies have come under scrutiny by the Drug Enforcement Administration and other government agencies.

NBC News, citing IQVIA, an analytics provider for the life sciences industry, reported that 41.4 million Adderall prescriptions were issued last year, up 10.4% from 2020.

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

Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.

The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.

Origovisualis/Getty Images

These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.

The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.

For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
 

The complexity of treating adolescents

WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.

Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.

The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.

However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.

The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.

Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.

The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.

“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.

WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”

Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.

SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.

And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.

It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”

SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”

And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”

Who uses WPATH to guide care? This is ‘a big unknown’

WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.

However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.

The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.

“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.

In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.

“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”

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

Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.

The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.

Origovisualis/Getty Images

These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.

The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.

For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
 

The complexity of treating adolescents

WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.

Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.

The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.

However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.

The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.

Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.

The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.

“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.

WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”

Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.

SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.

And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.

It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”

SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”

And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”

Who uses WPATH to guide care? This is ‘a big unknown’

WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.

However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.

The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.

“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.

In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.

“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”

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

Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.

The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.

Origovisualis/Getty Images

These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.

The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.

For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
 

The complexity of treating adolescents

WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.

Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.

The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.

However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.

The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.

Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.

The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.

“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.

WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”

Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.

SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.

And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.

It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”

SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”

And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”

Who uses WPATH to guide care? This is ‘a big unknown’

WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.

However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.

The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.

“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.

In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.

“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”

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

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In the past few months, “quiet quitting” has garnered increasing traction across social media platforms. My morning review of social media revealed thousands of posts ranging from “Why doing less at work could be good for you – and your employer” to “After ‘quiet quitting’ here comes ‘quiet firing.’ ”

But quiet quitting is neither quiet nor quitting.

Quiet quitting is a misnomer. Individuals are not quitting their jobs; rather, they are quitting the idea of consistently going “above and beyond” in the workplace as normal and necessary. In addition, quiet quitters are firmer with their boundaries, do not take on work above and beyond clearly stated expectations, do not respond after hours, and do not feel like they are “not doing their job” when they are not immediately available.

Individuals who “quiet quit” continue to meet the demands of their job but reject the hustle-culture mentality that you must always be available for more work and, most importantly, that your value as person and self-worth are defined and determined by your work. Quiet quitters believe that it is possible to have good boundaries and yet remain productive, engaged, and active within the workplace.

Earlier this month, NPR’s posted tutorial on how to set better boundaries at work garnered 491,000 views, reflecting employees’ difficulties in communicating their needs, thoughts, and availability to their employers. Quiet quitting refers to not only rejecting the idea of going above and beyond in the workplace but also feeling confident that there will not be negative ramifications for not consistently working beyond the expected requirements.

A focus on balance, life, loves, and family is rarely addressed or emphasized by traditional employers; employees have little skill in addressing boundaries and clarifying their value and availability. For decades, “needing” flexibility of any kind or valuing activities as much as your job were viewed as negative attributes, making those individuals less-desired employees.

Data support the quiet quitting trend. Gallup data reveal that employee engagement has fallen for 2 consecutive years in the U.S. workforce. Across the first quarter of 2022, Generation Z and younger Millennials report the lowest engagement across populations at 31%. More than half of this cohort, 54%, classified as “not engaged” in their workplace.

Why is quiet quitting gaining prominence now? COVID may play a role.

Many suggest that self-evaluation and establishing firmer boundaries is a logical response to emotional sequelae caused by COVID. Quiet quitting appears to have been fueled by the pandemic. Employees were forced into crisis mode by COVID; the lines between work, life, and home evaporated, allowing or forcing workers to evaluate their efficacy and satisfaction. With the structural impact of COVID reducing and a return to more standard work practices, it is expected that the job “rules” once held as truths come under evaluation and scrutiny.

Perhaps COVID has forced, and provided, another opportunity for us to closely examine our routines and habits and take stock of what really matters. Generations expectedly differ in their values and definitions of success. COVID has set prior established rules on fire, by forcing patterns and expectations that were neither expected nor wanted, within the context of a global health crisis. Within this backdrop, should we really believe our worth is determined by our job?

The truth is, we are still grieving what we lost during COVID and we have expectedly not assimilated to “the new normal.” Psychology has long recognized that losing structures and supports, routines and habits, causes symptoms of significant discomfort.

The idea that we would return to prior workplace expectations is naive. The idea we would “return to life as it was” is naive. It seems expected, then, that both employers and employees should evaluate their goals and communicate more openly about how each can be met.

It is incumbent upon the employers to set up clear guidelines regarding expectations, including rewards for performance and expectations for time, both within and outside of the work schedule. Employers must recognize symptoms of detachment in their employees and engage in the process of continuing clarifying roles and expectations while providing necessities for employees to succeed at their highest level. Employees, in turn, must self-examine their goals, communicate their needs, meet their responsibilities fully, and take on the challenge of determining their own definition of balance.

Maybe instead of quiet quitting, we should call it this new movement “self-awareness, growth, and evolution.” Hmmm, there’s an intriguing thought.

Dr. Calvery is professor of pediatrics at the University of Louisville (Ky.) She disclosed no relevant conflicts of interest.

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

In the past few months, “quiet quitting” has garnered increasing traction across social media platforms. My morning review of social media revealed thousands of posts ranging from “Why doing less at work could be good for you – and your employer” to “After ‘quiet quitting’ here comes ‘quiet firing.’ ”

But quiet quitting is neither quiet nor quitting.

Quiet quitting is a misnomer. Individuals are not quitting their jobs; rather, they are quitting the idea of consistently going “above and beyond” in the workplace as normal and necessary. In addition, quiet quitters are firmer with their boundaries, do not take on work above and beyond clearly stated expectations, do not respond after hours, and do not feel like they are “not doing their job” when they are not immediately available.

Individuals who “quiet quit” continue to meet the demands of their job but reject the hustle-culture mentality that you must always be available for more work and, most importantly, that your value as person and self-worth are defined and determined by your work. Quiet quitters believe that it is possible to have good boundaries and yet remain productive, engaged, and active within the workplace.

Earlier this month, NPR’s posted tutorial on how to set better boundaries at work garnered 491,000 views, reflecting employees’ difficulties in communicating their needs, thoughts, and availability to their employers. Quiet quitting refers to not only rejecting the idea of going above and beyond in the workplace but also feeling confident that there will not be negative ramifications for not consistently working beyond the expected requirements.

A focus on balance, life, loves, and family is rarely addressed or emphasized by traditional employers; employees have little skill in addressing boundaries and clarifying their value and availability. For decades, “needing” flexibility of any kind or valuing activities as much as your job were viewed as negative attributes, making those individuals less-desired employees.

Data support the quiet quitting trend. Gallup data reveal that employee engagement has fallen for 2 consecutive years in the U.S. workforce. Across the first quarter of 2022, Generation Z and younger Millennials report the lowest engagement across populations at 31%. More than half of this cohort, 54%, classified as “not engaged” in their workplace.

Why is quiet quitting gaining prominence now? COVID may play a role.

Many suggest that self-evaluation and establishing firmer boundaries is a logical response to emotional sequelae caused by COVID. Quiet quitting appears to have been fueled by the pandemic. Employees were forced into crisis mode by COVID; the lines between work, life, and home evaporated, allowing or forcing workers to evaluate their efficacy and satisfaction. With the structural impact of COVID reducing and a return to more standard work practices, it is expected that the job “rules” once held as truths come under evaluation and scrutiny.

Perhaps COVID has forced, and provided, another opportunity for us to closely examine our routines and habits and take stock of what really matters. Generations expectedly differ in their values and definitions of success. COVID has set prior established rules on fire, by forcing patterns and expectations that were neither expected nor wanted, within the context of a global health crisis. Within this backdrop, should we really believe our worth is determined by our job?

The truth is, we are still grieving what we lost during COVID and we have expectedly not assimilated to “the new normal.” Psychology has long recognized that losing structures and supports, routines and habits, causes symptoms of significant discomfort.

The idea that we would return to prior workplace expectations is naive. The idea we would “return to life as it was” is naive. It seems expected, then, that both employers and employees should evaluate their goals and communicate more openly about how each can be met.

It is incumbent upon the employers to set up clear guidelines regarding expectations, including rewards for performance and expectations for time, both within and outside of the work schedule. Employers must recognize symptoms of detachment in their employees and engage in the process of continuing clarifying roles and expectations while providing necessities for employees to succeed at their highest level. Employees, in turn, must self-examine their goals, communicate their needs, meet their responsibilities fully, and take on the challenge of determining their own definition of balance.

Maybe instead of quiet quitting, we should call it this new movement “self-awareness, growth, and evolution.” Hmmm, there’s an intriguing thought.

Dr. Calvery is professor of pediatrics at the University of Louisville (Ky.) She disclosed no relevant conflicts of interest.

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

In the past few months, “quiet quitting” has garnered increasing traction across social media platforms. My morning review of social media revealed thousands of posts ranging from “Why doing less at work could be good for you – and your employer” to “After ‘quiet quitting’ here comes ‘quiet firing.’ ”

But quiet quitting is neither quiet nor quitting.

Quiet quitting is a misnomer. Individuals are not quitting their jobs; rather, they are quitting the idea of consistently going “above and beyond” in the workplace as normal and necessary. In addition, quiet quitters are firmer with their boundaries, do not take on work above and beyond clearly stated expectations, do not respond after hours, and do not feel like they are “not doing their job” when they are not immediately available.

Individuals who “quiet quit” continue to meet the demands of their job but reject the hustle-culture mentality that you must always be available for more work and, most importantly, that your value as person and self-worth are defined and determined by your work. Quiet quitters believe that it is possible to have good boundaries and yet remain productive, engaged, and active within the workplace.

Earlier this month, NPR’s posted tutorial on how to set better boundaries at work garnered 491,000 views, reflecting employees’ difficulties in communicating their needs, thoughts, and availability to their employers. Quiet quitting refers to not only rejecting the idea of going above and beyond in the workplace but also feeling confident that there will not be negative ramifications for not consistently working beyond the expected requirements.

A focus on balance, life, loves, and family is rarely addressed or emphasized by traditional employers; employees have little skill in addressing boundaries and clarifying their value and availability. For decades, “needing” flexibility of any kind or valuing activities as much as your job were viewed as negative attributes, making those individuals less-desired employees.

Data support the quiet quitting trend. Gallup data reveal that employee engagement has fallen for 2 consecutive years in the U.S. workforce. Across the first quarter of 2022, Generation Z and younger Millennials report the lowest engagement across populations at 31%. More than half of this cohort, 54%, classified as “not engaged” in their workplace.

Why is quiet quitting gaining prominence now? COVID may play a role.

Many suggest that self-evaluation and establishing firmer boundaries is a logical response to emotional sequelae caused by COVID. Quiet quitting appears to have been fueled by the pandemic. Employees were forced into crisis mode by COVID; the lines between work, life, and home evaporated, allowing or forcing workers to evaluate their efficacy and satisfaction. With the structural impact of COVID reducing and a return to more standard work practices, it is expected that the job “rules” once held as truths come under evaluation and scrutiny.

Perhaps COVID has forced, and provided, another opportunity for us to closely examine our routines and habits and take stock of what really matters. Generations expectedly differ in their values and definitions of success. COVID has set prior established rules on fire, by forcing patterns and expectations that were neither expected nor wanted, within the context of a global health crisis. Within this backdrop, should we really believe our worth is determined by our job?

The truth is, we are still grieving what we lost during COVID and we have expectedly not assimilated to “the new normal.” Psychology has long recognized that losing structures and supports, routines and habits, causes symptoms of significant discomfort.

The idea that we would return to prior workplace expectations is naive. The idea we would “return to life as it was” is naive. It seems expected, then, that both employers and employees should evaluate their goals and communicate more openly about how each can be met.

It is incumbent upon the employers to set up clear guidelines regarding expectations, including rewards for performance and expectations for time, both within and outside of the work schedule. Employers must recognize symptoms of detachment in their employees and engage in the process of continuing clarifying roles and expectations while providing necessities for employees to succeed at their highest level. Employees, in turn, must self-examine their goals, communicate their needs, meet their responsibilities fully, and take on the challenge of determining their own definition of balance.

Maybe instead of quiet quitting, we should call it this new movement “self-awareness, growth, and evolution.” Hmmm, there’s an intriguing thought.

Dr. Calvery is professor of pediatrics at the University of Louisville (Ky.) She disclosed no relevant conflicts of interest.

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

Who would have thought we would need to refresh our knowledge on polio virus in 2022? Fate seems cruel to add this concern on the heels of SARS-CoV-2, monkeypox, abnormal seasons for RSV, acute flaccid myelitis (AFM) linked to enteroviruses, and a summer of parechovirus causing infant meningitis. But confirmation that indeed an adult had polio with paralytic disease raises concerns among public health groups and ordinary citizens alike, particularly those who remember polio in its heyday.

History: In the summer of 1952, polio was among the most feared diseases on the planet. Families were advised to not allow children to congregate in groups or use public swimming pools; little league baseball games were being canceled and there was talk of not opening schools for the fall. Every parent’s nightmare seemed to be the nonspecific febrile summer illness that led to paralytic sequelae. TV news included videos of the iron lung wards in hospitals across the country. Medical providers felt powerless, only able to give nonspecific preventive advice. There was no specific antiviral (there still isn’t) and vaccines seemed a long way off.

Then came the news that Dr. Jonas Salk’s group had gotten an inactivated polio vaccine (IPV) approved for general use in 1955. Families were excited to have their children vaccinated. Paralytic polio cases dropped like a rock from approximately 22,000/year in 1952 to approximately 2,200 in 1956. A surge to near 6,000 cases in 1959 led to Dr. Albert Sabin’s oral polio vaccine (OPV), which supplanted IPV in 1961. OPV had the advantages of: 1) Inducing mucosal as well as serum antibodies, 2) more durable responses, and 3) immunity in unvaccinated persons exposed to vaccine virus that had been shed in stools into wastewater and rivers.

By 1964, polio had nearly disappeared. The last wild-type indigenous U.S. case was in 1979. By 1994, all the Americas were declared polio free. Because the only U.S. paralytic polio cases thereafter were foreign imports or were associated with oral vaccine strains (so-called vaccine-associated paralytic polio [VAPP]), OPV was replaced by an enhanced IPV in 2000 to prevent further VAPP.

Polio facts: Polio is asymptomatic in about 70% of infections. Among the 30% with symptoms, paralysis occurs infrequently, with the overall rate of paralytic infections being 0.5% (rate varies by virus type with type 3 having the highest rate).¹ Why then was the world so afraid of polio? If every person in a U.S. birth cohort (about 3.7 million) was unvaccinated and became infected with poliovirus, more than 18,000 would get paralytic polio and almost 1,300 would die. Of note, adults have a higher chance of paralytic polio after infection than children.

Concerns in 2022: Persons vaccinated with at least three doses of either IPV or OPV have historically been protected from paralytic polio (99% protection). But are we sure that the United States remains protected against polio after 2 decades of IPV being the only vaccine? Polio could be reintroduced at any time to the United States from countries with reported cases that likely arose because of low vaccination rates related to war, famine, or political upheavals (Malawi, Mozambique, Nigeria, Pakistan, and Afghanistan).² The proof? The recent confirmed New York case.

International efforts resulted in global eradication of two polio wild-types viruses (type 2 in 2015 and type 3 in 2019). Nevertheless, vaccine-derived, virulent polio virus (VDPV) type 2 and VDPV-3 still circulate in some areas, particularly Africa (VDPV-2) and Israel (VDPV-3). The above-mentioned U.S. case is an unvaccinated adult traveler who went to an area where VDPV-2 circulates and developed disease after returning home.³ So, it was not an indigenous reappearance in the United States and it was not a breakthrough case in a vaccinated person. But it is sobering to realize that all who are unvaccinated remain at risk for paralytic polio in 2022, particularly because vaccination rates declined nearly everywhere during the initial COVID-19 pandemic. We are still catching up, with vaccination rates under 50% in some ZIP codes.⁴

Are VDPVs circulating in some parts of the United States? Interestingly, wastewater surveillance programs may be the most economical and practical way to perform polio surveillance. Such a program detected polio virus in London wastewater in June 2022.⁵ New York has recently detected polio in wastewater during testing begun because of the recent case.⁶

Good news: For paralytic polio, seropositivity at any titer indicates protection, so U.S. serosurveillance data would also be informative. How durable is polio protection in the IPV era? Available data suggest that even though we have used only IPV these past 20 years, seropositivity rates among vaccinees with at least three doses of either IPV or OPV should persist for decades and likely for life. Even before polio became a concern this year, the Centers for Disease Control and Prevention, being proactive, wanted to ensure that the enhanced IPV was producing durable immunity and that persons of all ages remained seropositive to the three polio virus types over 10 years after discontinuing OPV use in 2012.

The CDC collaborated with investigators in Kansas City, Mo., to evaluate titers and seropositivity to all three types in a 2- to 85-year-old otherwise healthy cohort with demographics that mirrored the 2010 census for the Kansas City region, which in turn mirrored the national 2021 census data.⁷ There were approximately 100 persons in each age cohort, with 200 below age 11 years (the cohort that had received only IPV). Serology was performed at the CDC.

Overall seropositivity rates were high, but lower for type 3 (83.3%) and type 2 (90.7%) than type 1 (94.4%). Of note, most of those seronegative for one or more types were among 2- to 3-year-olds who had not completed their full IPV series, with most seronegative results being against polio types 1 and 3. Further, five, who were confirmed as having received no polio vaccine, were seronegative for all three types. Two with no available vaccine records (over 18 years old) were also seronegative for all three types.

So, regardless of the era in which one got polio vaccine, vaccine protection appears to persist indefinitely after three doses. Even 80-year-olds were still seropositive if they had three doses. We can confidently reassure our patients that the vaccine still works; the persons who need to fear polio in 2022 are those who are not vaccinated or have had fewer than three doses, particularly if they travel to areas of persistent polio. Wild type 1 virus persists in a few countries as does VDPV type 2 and VDPV type 3. Importantly, wild type 2 and wild type 3 (with the lowest seropositivity in 2012 study) have been eliminated globally so the only circulating type 2 and type 3 polio virus is VDPV in a few countries. Travel to these countries warrants review of polio vaccine records and CDC or WHO current recommendations for travelers to those countries.
 

Dr. Harrison is a professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. Email him at [email protected].

References

1. Poliomyelitis. World Health Organization fact sheet, 2022 Jul 4..

2. Franco-Paredes C et al. Lancet Infect Dis. 2022 Aug 16. doi: 10.1016/S1473-3099(22)00548-5.

3. Link-Gelles R et al. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1065-8.

4. “Polio vaccination rate for 2-year-olds is as low as 37% in parts of N.Y. county where paralysis case was found,” NBC News, Erika Edwards, 2022 Aug 16. 5. Vaccine-derived poliovirus type 2 (VDPV2) detected in environmental samples in London. Polioeradication.org. 2022 Jun 22.

6. “NYSDOH and NYCDOHMH wastewater monitoring identifies polio in New York City and urges unvaccinated New Yorkers to get vaccinated now,” nyc.gov. 2022 Aug 12.

7. Wallace GS et al. Hum Vaccin Immunother. 2017;13(4):776-83.

Who would have thought we would need to refresh our knowledge on polio virus in 2022? Fate seems cruel to add this concern on the heels of SARS-CoV-2, monkeypox, abnormal seasons for RSV, acute flaccid myelitis (AFM) linked to enteroviruses, and a summer of parechovirus causing infant meningitis. But confirmation that indeed an adult had polio with paralytic disease raises concerns among public health groups and ordinary citizens alike, particularly those who remember polio in its heyday.

History: In the summer of 1952, polio was among the most feared diseases on the planet. Families were advised to not allow children to congregate in groups or use public swimming pools; little league baseball games were being canceled and there was talk of not opening schools for the fall. Every parent’s nightmare seemed to be the nonspecific febrile summer illness that led to paralytic sequelae. TV news included videos of the iron lung wards in hospitals across the country. Medical providers felt powerless, only able to give nonspecific preventive advice. There was no specific antiviral (there still isn’t) and vaccines seemed a long way off.

Then came the news that Dr. Jonas Salk’s group had gotten an inactivated polio vaccine (IPV) approved for general use in 1955. Families were excited to have their children vaccinated. Paralytic polio cases dropped like a rock from approximately 22,000/year in 1952 to approximately 2,200 in 1956. A surge to near 6,000 cases in 1959 led to Dr. Albert Sabin’s oral polio vaccine (OPV), which supplanted IPV in 1961. OPV had the advantages of: 1) Inducing mucosal as well as serum antibodies, 2) more durable responses, and 3) immunity in unvaccinated persons exposed to vaccine virus that had been shed in stools into wastewater and rivers.

By 1964, polio had nearly disappeared. The last wild-type indigenous U.S. case was in 1979. By 1994, all the Americas were declared polio free. Because the only U.S. paralytic polio cases thereafter were foreign imports or were associated with oral vaccine strains (so-called vaccine-associated paralytic polio [VAPP]), OPV was replaced by an enhanced IPV in 2000 to prevent further VAPP.

Polio facts: Polio is asymptomatic in about 70% of infections. Among the 30% with symptoms, paralysis occurs infrequently, with the overall rate of paralytic infections being 0.5% (rate varies by virus type with type 3 having the highest rate).¹ Why then was the world so afraid of polio? If every person in a U.S. birth cohort (about 3.7 million) was unvaccinated and became infected with poliovirus, more than 18,000 would get paralytic polio and almost 1,300 would die. Of note, adults have a higher chance of paralytic polio after infection than children.

Concerns in 2022: Persons vaccinated with at least three doses of either IPV or OPV have historically been protected from paralytic polio (99% protection). But are we sure that the United States remains protected against polio after 2 decades of IPV being the only vaccine? Polio could be reintroduced at any time to the United States from countries with reported cases that likely arose because of low vaccination rates related to war, famine, or political upheavals (Malawi, Mozambique, Nigeria, Pakistan, and Afghanistan).² The proof? The recent confirmed New York case.

International efforts resulted in global eradication of two polio wild-types viruses (type 2 in 2015 and type 3 in 2019). Nevertheless, vaccine-derived, virulent polio virus (VDPV) type 2 and VDPV-3 still circulate in some areas, particularly Africa (VDPV-2) and Israel (VDPV-3). The above-mentioned U.S. case is an unvaccinated adult traveler who went to an area where VDPV-2 circulates and developed disease after returning home.³ So, it was not an indigenous reappearance in the United States and it was not a breakthrough case in a vaccinated person. But it is sobering to realize that all who are unvaccinated remain at risk for paralytic polio in 2022, particularly because vaccination rates declined nearly everywhere during the initial COVID-19 pandemic. We are still catching up, with vaccination rates under 50% in some ZIP codes.⁴

Are VDPVs circulating in some parts of the United States? Interestingly, wastewater surveillance programs may be the most economical and practical way to perform polio surveillance. Such a program detected polio virus in London wastewater in June 2022.⁵ New York has recently detected polio in wastewater during testing begun because of the recent case.⁶

Good news: For paralytic polio, seropositivity at any titer indicates protection, so U.S. serosurveillance data would also be informative. How durable is polio protection in the IPV era? Available data suggest that even though we have used only IPV these past 20 years, seropositivity rates among vaccinees with at least three doses of either IPV or OPV should persist for decades and likely for life. Even before polio became a concern this year, the Centers for Disease Control and Prevention, being proactive, wanted to ensure that the enhanced IPV was producing durable immunity and that persons of all ages remained seropositive to the three polio virus types over 10 years after discontinuing OPV use in 2012.

The CDC collaborated with investigators in Kansas City, Mo., to evaluate titers and seropositivity to all three types in a 2- to 85-year-old otherwise healthy cohort with demographics that mirrored the 2010 census for the Kansas City region, which in turn mirrored the national 2021 census data.⁷ There were approximately 100 persons in each age cohort, with 200 below age 11 years (the cohort that had received only IPV). Serology was performed at the CDC.

Overall seropositivity rates were high, but lower for type 3 (83.3%) and type 2 (90.7%) than type 1 (94.4%). Of note, most of those seronegative for one or more types were among 2- to 3-year-olds who had not completed their full IPV series, with most seronegative results being against polio types 1 and 3. Further, five, who were confirmed as having received no polio vaccine, were seronegative for all three types. Two with no available vaccine records (over 18 years old) were also seronegative for all three types.

So, regardless of the era in which one got polio vaccine, vaccine protection appears to persist indefinitely after three doses. Even 80-year-olds were still seropositive if they had three doses. We can confidently reassure our patients that the vaccine still works; the persons who need to fear polio in 2022 are those who are not vaccinated or have had fewer than three doses, particularly if they travel to areas of persistent polio. Wild type 1 virus persists in a few countries as does VDPV type 2 and VDPV type 3. Importantly, wild type 2 and wild type 3 (with the lowest seropositivity in 2012 study) have been eliminated globally so the only circulating type 2 and type 3 polio virus is VDPV in a few countries. Travel to these countries warrants review of polio vaccine records and CDC or WHO current recommendations for travelers to those countries.
 

Dr. Harrison is a professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. Email him at [email protected].

References

1. Poliomyelitis. World Health Organization fact sheet, 2022 Jul 4..

2. Franco-Paredes C et al. Lancet Infect Dis. 2022 Aug 16. doi: 10.1016/S1473-3099(22)00548-5.

3. Link-Gelles R et al. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1065-8.

4. “Polio vaccination rate for 2-year-olds is as low as 37% in parts of N.Y. county where paralysis case was found,” NBC News, Erika Edwards, 2022 Aug 16. 5. Vaccine-derived poliovirus type 2 (VDPV2) detected in environmental samples in London. Polioeradication.org. 2022 Jun 22.

6. “NYSDOH and NYCDOHMH wastewater monitoring identifies polio in New York City and urges unvaccinated New Yorkers to get vaccinated now,” nyc.gov. 2022 Aug 12.

7. Wallace GS et al. Hum Vaccin Immunother. 2017;13(4):776-83.

Who would have thought we would need to refresh our knowledge on polio virus in 2022? Fate seems cruel to add this concern on the heels of SARS-CoV-2, monkeypox, abnormal seasons for RSV, acute flaccid myelitis (AFM) linked to enteroviruses, and a summer of parechovirus causing infant meningitis. But confirmation that indeed an adult had polio with paralytic disease raises concerns among public health groups and ordinary citizens alike, particularly those who remember polio in its heyday.

History: In the summer of 1952, polio was among the most feared diseases on the planet. Families were advised to not allow children to congregate in groups or use public swimming pools; little league baseball games were being canceled and there was talk of not opening schools for the fall. Every parent’s nightmare seemed to be the nonspecific febrile summer illness that led to paralytic sequelae. TV news included videos of the iron lung wards in hospitals across the country. Medical providers felt powerless, only able to give nonspecific preventive advice. There was no specific antiviral (there still isn’t) and vaccines seemed a long way off.

Then came the news that Dr. Jonas Salk’s group had gotten an inactivated polio vaccine (IPV) approved for general use in 1955. Families were excited to have their children vaccinated. Paralytic polio cases dropped like a rock from approximately 22,000/year in 1952 to approximately 2,200 in 1956. A surge to near 6,000 cases in 1959 led to Dr. Albert Sabin’s oral polio vaccine (OPV), which supplanted IPV in 1961. OPV had the advantages of: 1) Inducing mucosal as well as serum antibodies, 2) more durable responses, and 3) immunity in unvaccinated persons exposed to vaccine virus that had been shed in stools into wastewater and rivers.

By 1964, polio had nearly disappeared. The last wild-type indigenous U.S. case was in 1979. By 1994, all the Americas were declared polio free. Because the only U.S. paralytic polio cases thereafter were foreign imports or were associated with oral vaccine strains (so-called vaccine-associated paralytic polio [VAPP]), OPV was replaced by an enhanced IPV in 2000 to prevent further VAPP.

Polio facts: Polio is asymptomatic in about 70% of infections. Among the 30% with symptoms, paralysis occurs infrequently, with the overall rate of paralytic infections being 0.5% (rate varies by virus type with type 3 having the highest rate).¹ Why then was the world so afraid of polio? If every person in a U.S. birth cohort (about 3.7 million) was unvaccinated and became infected with poliovirus, more than 18,000 would get paralytic polio and almost 1,300 would die. Of note, adults have a higher chance of paralytic polio after infection than children.

Concerns in 2022: Persons vaccinated with at least three doses of either IPV or OPV have historically been protected from paralytic polio (99% protection). But are we sure that the United States remains protected against polio after 2 decades of IPV being the only vaccine? Polio could be reintroduced at any time to the United States from countries with reported cases that likely arose because of low vaccination rates related to war, famine, or political upheavals (Malawi, Mozambique, Nigeria, Pakistan, and Afghanistan).² The proof? The recent confirmed New York case.

International efforts resulted in global eradication of two polio wild-types viruses (type 2 in 2015 and type 3 in 2019). Nevertheless, vaccine-derived, virulent polio virus (VDPV) type 2 and VDPV-3 still circulate in some areas, particularly Africa (VDPV-2) and Israel (VDPV-3). The above-mentioned U.S. case is an unvaccinated adult traveler who went to an area where VDPV-2 circulates and developed disease after returning home.³ So, it was not an indigenous reappearance in the United States and it was not a breakthrough case in a vaccinated person. But it is sobering to realize that all who are unvaccinated remain at risk for paralytic polio in 2022, particularly because vaccination rates declined nearly everywhere during the initial COVID-19 pandemic. We are still catching up, with vaccination rates under 50% in some ZIP codes.⁴

Are VDPVs circulating in some parts of the United States? Interestingly, wastewater surveillance programs may be the most economical and practical way to perform polio surveillance. Such a program detected polio virus in London wastewater in June 2022.⁵ New York has recently detected polio in wastewater during testing begun because of the recent case.⁶

Good news: For paralytic polio, seropositivity at any titer indicates protection, so U.S. serosurveillance data would also be informative. How durable is polio protection in the IPV era? Available data suggest that even though we have used only IPV these past 20 years, seropositivity rates among vaccinees with at least three doses of either IPV or OPV should persist for decades and likely for life. Even before polio became a concern this year, the Centers for Disease Control and Prevention, being proactive, wanted to ensure that the enhanced IPV was producing durable immunity and that persons of all ages remained seropositive to the three polio virus types over 10 years after discontinuing OPV use in 2012.

The CDC collaborated with investigators in Kansas City, Mo., to evaluate titers and seropositivity to all three types in a 2- to 85-year-old otherwise healthy cohort with demographics that mirrored the 2010 census for the Kansas City region, which in turn mirrored the national 2021 census data.⁷ There were approximately 100 persons in each age cohort, with 200 below age 11 years (the cohort that had received only IPV). Serology was performed at the CDC.

Overall seropositivity rates were high, but lower for type 3 (83.3%) and type 2 (90.7%) than type 1 (94.4%). Of note, most of those seronegative for one or more types were among 2- to 3-year-olds who had not completed their full IPV series, with most seronegative results being against polio types 1 and 3. Further, five, who were confirmed as having received no polio vaccine, were seronegative for all three types. Two with no available vaccine records (over 18 years old) were also seronegative for all three types.

So, regardless of the era in which one got polio vaccine, vaccine protection appears to persist indefinitely after three doses. Even 80-year-olds were still seropositive if they had three doses. We can confidently reassure our patients that the vaccine still works; the persons who need to fear polio in 2022 are those who are not vaccinated or have had fewer than three doses, particularly if they travel to areas of persistent polio. Wild type 1 virus persists in a few countries as does VDPV type 2 and VDPV type 3. Importantly, wild type 2 and wild type 3 (with the lowest seropositivity in 2012 study) have been eliminated globally so the only circulating type 2 and type 3 polio virus is VDPV in a few countries. Travel to these countries warrants review of polio vaccine records and CDC or WHO current recommendations for travelers to those countries.
 

Dr. Harrison is a professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. Email him at [email protected].

References

1. Poliomyelitis. World Health Organization fact sheet, 2022 Jul 4..

2. Franco-Paredes C et al. Lancet Infect Dis. 2022 Aug 16. doi: 10.1016/S1473-3099(22)00548-5.

3. Link-Gelles R et al. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1065-8.

4. “Polio vaccination rate for 2-year-olds is as low as 37% in parts of N.Y. county where paralysis case was found,” NBC News, Erika Edwards, 2022 Aug 16. 5. Vaccine-derived poliovirus type 2 (VDPV2) detected in environmental samples in London. Polioeradication.org. 2022 Jun 22.

6. “NYSDOH and NYCDOHMH wastewater monitoring identifies polio in New York City and urges unvaccinated New Yorkers to get vaccinated now,” nyc.gov. 2022 Aug 12.

7. Wallace GS et al. Hum Vaccin Immunother. 2017;13(4):776-83.