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Choice of infant sleep location is multifactorial
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
FROM PEDIATRICS
‘Antibacterial’ soap labels still list banned ingredients
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
Like a hot potato
Most of us did our postgraduate training in tertiary medical centers, ivory towers of medicine often attached to or closely affiliated with medical schools. These are the places where the buck stops. Occasionally, a very complex patient might be sent to another tertiary center that claims to have a supersubspecialist, a one-of-a-kind physician with nationally recognized expertise. But for most patients, the tertiary medical center is the end of the line, and his or her physicians must manage with the resources at hand. They may confer with one another but there is no place for them to pass the buck.
But most of us who chose primary care left the comforting cocoon of the teaching hospital complex when we finished our training. Those first few months and years in the hinterland can be angst producing. Until we have established our own personal networks of consultants and mentors, patients with more than run-of-the-mill complaints may prompt us to reach for the phone or fire off an email call for help to our recently departed mother ship.
It can take awhile to establish the self-confidence – or at least the appearance of self-confidence – that physicians are expected to exude. But even after years of experience, none of us wants to watch a patient die or suffer preventable complications under our care when we know there is another facility that can provide a higher lever of care just an ambulance ride or short helicopter trip away.
Our primary concern is of course assuring that our patient is receiving the best care. How quickly we reach for the phone to refer out the most fragile patients depends on several factors. Do we practice in a community that has a historic reputation of having a low threshold for malpractice suits? How well do we know the patient and her family? Have we had time to establish bidirectional trust?
Is the patient’s diagnosis one that we feel comfortable with or is the diagnosis one that we believe could quickly deteriorate without warning? For example, a recently published study revealed that 20% of pediatric trauma patients were overtriaged and that the mechanism of injury – firearms or motor vehicle accidents – appeared to have an outsized influence in the triage decision (Trauma Surg Acute Care Open. 2019 Dec 29. doi: 10.1136/tsaco-2019-000300).
Because I have no experience with firearm injuries and minimal experience with motor vehicle injuries I can understand why the emergency medical technicians might be quick to ship these patients to the trauma center. However, I hope that, were I offered better training and more opportunities to gain experience with these types of injuries, I would have a lower overtriage percentage.
Which begs the question of what is an acceptable rate of overtriage or overreferral? It’s the same old question of how many normal appendixes should one remove to avoid a fatal outcome. Each of us arrives at a given clinical crossroads with our own level of experience and comfort level.
But in the final analysis it boils down to a personal decision and our own basic level of anxiety. Let’s face it, some of us worry more than others. Physicians come in all shades of anxiety. A hot potato in your hands may feel only room temperature to me.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
Most of us did our postgraduate training in tertiary medical centers, ivory towers of medicine often attached to or closely affiliated with medical schools. These are the places where the buck stops. Occasionally, a very complex patient might be sent to another tertiary center that claims to have a supersubspecialist, a one-of-a-kind physician with nationally recognized expertise. But for most patients, the tertiary medical center is the end of the line, and his or her physicians must manage with the resources at hand. They may confer with one another but there is no place for them to pass the buck.
But most of us who chose primary care left the comforting cocoon of the teaching hospital complex when we finished our training. Those first few months and years in the hinterland can be angst producing. Until we have established our own personal networks of consultants and mentors, patients with more than run-of-the-mill complaints may prompt us to reach for the phone or fire off an email call for help to our recently departed mother ship.
It can take awhile to establish the self-confidence – or at least the appearance of self-confidence – that physicians are expected to exude. But even after years of experience, none of us wants to watch a patient die or suffer preventable complications under our care when we know there is another facility that can provide a higher lever of care just an ambulance ride or short helicopter trip away.
Our primary concern is of course assuring that our patient is receiving the best care. How quickly we reach for the phone to refer out the most fragile patients depends on several factors. Do we practice in a community that has a historic reputation of having a low threshold for malpractice suits? How well do we know the patient and her family? Have we had time to establish bidirectional trust?
Is the patient’s diagnosis one that we feel comfortable with or is the diagnosis one that we believe could quickly deteriorate without warning? For example, a recently published study revealed that 20% of pediatric trauma patients were overtriaged and that the mechanism of injury – firearms or motor vehicle accidents – appeared to have an outsized influence in the triage decision (Trauma Surg Acute Care Open. 2019 Dec 29. doi: 10.1136/tsaco-2019-000300).
Because I have no experience with firearm injuries and minimal experience with motor vehicle injuries I can understand why the emergency medical technicians might be quick to ship these patients to the trauma center. However, I hope that, were I offered better training and more opportunities to gain experience with these types of injuries, I would have a lower overtriage percentage.
Which begs the question of what is an acceptable rate of overtriage or overreferral? It’s the same old question of how many normal appendixes should one remove to avoid a fatal outcome. Each of us arrives at a given clinical crossroads with our own level of experience and comfort level.
But in the final analysis it boils down to a personal decision and our own basic level of anxiety. Let’s face it, some of us worry more than others. Physicians come in all shades of anxiety. A hot potato in your hands may feel only room temperature to me.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
Most of us did our postgraduate training in tertiary medical centers, ivory towers of medicine often attached to or closely affiliated with medical schools. These are the places where the buck stops. Occasionally, a very complex patient might be sent to another tertiary center that claims to have a supersubspecialist, a one-of-a-kind physician with nationally recognized expertise. But for most patients, the tertiary medical center is the end of the line, and his or her physicians must manage with the resources at hand. They may confer with one another but there is no place for them to pass the buck.
But most of us who chose primary care left the comforting cocoon of the teaching hospital complex when we finished our training. Those first few months and years in the hinterland can be angst producing. Until we have established our own personal networks of consultants and mentors, patients with more than run-of-the-mill complaints may prompt us to reach for the phone or fire off an email call for help to our recently departed mother ship.
It can take awhile to establish the self-confidence – or at least the appearance of self-confidence – that physicians are expected to exude. But even after years of experience, none of us wants to watch a patient die or suffer preventable complications under our care when we know there is another facility that can provide a higher lever of care just an ambulance ride or short helicopter trip away.
Our primary concern is of course assuring that our patient is receiving the best care. How quickly we reach for the phone to refer out the most fragile patients depends on several factors. Do we practice in a community that has a historic reputation of having a low threshold for malpractice suits? How well do we know the patient and her family? Have we had time to establish bidirectional trust?
Is the patient’s diagnosis one that we feel comfortable with or is the diagnosis one that we believe could quickly deteriorate without warning? For example, a recently published study revealed that 20% of pediatric trauma patients were overtriaged and that the mechanism of injury – firearms or motor vehicle accidents – appeared to have an outsized influence in the triage decision (Trauma Surg Acute Care Open. 2019 Dec 29. doi: 10.1136/tsaco-2019-000300).
Because I have no experience with firearm injuries and minimal experience with motor vehicle injuries I can understand why the emergency medical technicians might be quick to ship these patients to the trauma center. However, I hope that, were I offered better training and more opportunities to gain experience with these types of injuries, I would have a lower overtriage percentage.
Which begs the question of what is an acceptable rate of overtriage or overreferral? It’s the same old question of how many normal appendixes should one remove to avoid a fatal outcome. Each of us arrives at a given clinical crossroads with our own level of experience and comfort level.
But in the final analysis it boils down to a personal decision and our own basic level of anxiety. Let’s face it, some of us worry more than others. Physicians come in all shades of anxiety. A hot potato in your hands may feel only room temperature to me.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
The Mississippi solution
I agree wholeheartedly with Dr. William G. Wilkoff’s doubts that an increase in medical schools/students and/or foreign medical graduates is the answer to the physician shortage felt by many areas of the country (Letters From Maine, “Help Wanted,” Nov. 2019, page 19). All you have to do is look at the glut of physicians – and just about any other profession – in metropolitan areas versus rural America, and ask basic questions regarding why those doctors practice where they do. You will quickly discover that most are willing to trade the possibility of a higher salary in areas where their presence is more needed to achieve more school choices, jobs for a spouse, and likely a more favorable call schedule. Something more attractive than salary or the prospect of more “elbow room” is desired.
Here in Mississippi we may have found an answer to the problem. A few years ago our state legislature started the Mississippi Rural Health Scholarship Program that pays for recipients to attend a state-run medical school on scholarship in exchange for agreeing to practice at least 4 years in a rural area of the state (less than 20k population) following their primary care residency (family medicine, pediatrics, ob.gyn., med-peds, internal medicine, and, recently added, psychiatry). Although a recent increase in the number of pediatric residency slots at our state’s sole program will no doubt also have a positive effect to this end, such a scholarship program as the one implemented by Mississippi is the best way to compete with the various intangibles that lead people to choose bigger cities over rural areas of the state to practice their trade. Once there, many – like myself – will find that such a practice is not only a good business decision but often is a wonderful place to raise a family. Meanwhile, our own practice just added a fourth physician as a result of said Rural Health Scholarship Program, and we could not be more satisfied with the result.
I agree wholeheartedly with Dr. William G. Wilkoff’s doubts that an increase in medical schools/students and/or foreign medical graduates is the answer to the physician shortage felt by many areas of the country (Letters From Maine, “Help Wanted,” Nov. 2019, page 19). All you have to do is look at the glut of physicians – and just about any other profession – in metropolitan areas versus rural America, and ask basic questions regarding why those doctors practice where they do. You will quickly discover that most are willing to trade the possibility of a higher salary in areas where their presence is more needed to achieve more school choices, jobs for a spouse, and likely a more favorable call schedule. Something more attractive than salary or the prospect of more “elbow room” is desired.
Here in Mississippi we may have found an answer to the problem. A few years ago our state legislature started the Mississippi Rural Health Scholarship Program that pays for recipients to attend a state-run medical school on scholarship in exchange for agreeing to practice at least 4 years in a rural area of the state (less than 20k population) following their primary care residency (family medicine, pediatrics, ob.gyn., med-peds, internal medicine, and, recently added, psychiatry). Although a recent increase in the number of pediatric residency slots at our state’s sole program will no doubt also have a positive effect to this end, such a scholarship program as the one implemented by Mississippi is the best way to compete with the various intangibles that lead people to choose bigger cities over rural areas of the state to practice their trade. Once there, many – like myself – will find that such a practice is not only a good business decision but often is a wonderful place to raise a family. Meanwhile, our own practice just added a fourth physician as a result of said Rural Health Scholarship Program, and we could not be more satisfied with the result.
I agree wholeheartedly with Dr. William G. Wilkoff’s doubts that an increase in medical schools/students and/or foreign medical graduates is the answer to the physician shortage felt by many areas of the country (Letters From Maine, “Help Wanted,” Nov. 2019, page 19). All you have to do is look at the glut of physicians – and just about any other profession – in metropolitan areas versus rural America, and ask basic questions regarding why those doctors practice where they do. You will quickly discover that most are willing to trade the possibility of a higher salary in areas where their presence is more needed to achieve more school choices, jobs for a spouse, and likely a more favorable call schedule. Something more attractive than salary or the prospect of more “elbow room” is desired.
Here in Mississippi we may have found an answer to the problem. A few years ago our state legislature started the Mississippi Rural Health Scholarship Program that pays for recipients to attend a state-run medical school on scholarship in exchange for agreeing to practice at least 4 years in a rural area of the state (less than 20k population) following their primary care residency (family medicine, pediatrics, ob.gyn., med-peds, internal medicine, and, recently added, psychiatry). Although a recent increase in the number of pediatric residency slots at our state’s sole program will no doubt also have a positive effect to this end, such a scholarship program as the one implemented by Mississippi is the best way to compete with the various intangibles that lead people to choose bigger cities over rural areas of the state to practice their trade. Once there, many – like myself – will find that such a practice is not only a good business decision but often is a wonderful place to raise a family. Meanwhile, our own practice just added a fourth physician as a result of said Rural Health Scholarship Program, and we could not be more satisfied with the result.
The power of an odd couple
The time has come for good men and women to unite and rise up against a common foe. For too long nurses and doctors have labored under the tyranny of a dictator who claimed to help them provide high-quality care for their patients while at the same time cutting their paperwork to nil. But like most autocrats he failed to engage his subjects in a meaningful dialogue as each new version of his promised improvements rolled off the drawing board. When the caregivers were slow to adopt these new nonsystems he offered them financial incentives and issued threats to their survival. Although they were warned that there might be uncomfortable adjustment periods, the caregivers were promised that the steep learning curves would level out and their professional lives would again be valued and productive.
Of course, the dictator is not a single person but a motley and disorganized conglomerate of user- and patient-unfriendly electronic health record nonsystems. Ask almost any nurse or physician for her feelings about computer-based medical record systems, and you will hear tales of long hours, disengagement, and frustration. Caregivers are unhappy at all levels, and patients have grown tired of their nurses and physicians spending most of their time looking at computer screens.
You certainly have heard this all before. But you are hearing it in hospital hallways and grocery store checkout lines as a low rumble of discontent emerging from separate individuals, not as a well-articulated and widely distributed voice of physicians as a group. To some extent this relative silence is because there is no such group, at least not in same mold as a labor union. The term “labor union” may make you uncomfortable. But given the current climate in medicine, unionizing may be the best and only way to effect change.
But organizing to effect change in the workplace isn’t part of the physician genome. In the 1960s, a group of house officers in Boston engaged in a heal-in to successfully improve their salaries and working conditions. But over the ensuing half century physicians have remained tragically silent in the face of a changing workplace landscape in which they have gone from being independent owner operators in control of their destinies to becoming employees feeling powerless to improve their working conditions. This perceived impotence has escalated in the face of the challenge posed by the introduction of dysfunctional EHRs.
Ironically, a solution is at almost every physician’s elbow. In a recent New York Times opinion piece Theresa Brown and Stephen Bergman acknowledge that physicians don’t seem prepared to mount a meaningful response to the challenge to the failed promise of EHRs (“Doctors, Nurses and the Paperwork Crisis That Could Unite Them,” Dec. 31, 2019). They point out that, over the last half century, physicians have remained isolated on the sidelines, finding just enough voice to grumble. Nurses have in a variety of situations organized to effect change in their working conditions – in some cases by forming labor unions.
The authors of this op-ed piece, a physician and a nurse, make a strong argument that the time has come for nurses and doctors shake off the shackles of their stereotypic roles and join in creating a loud, forceful, and effective voice to demand a working environment in which the computer functions as an asset and no longer as the terrible burden it has become. Neither group has the power to do it alone, but together they may be able to turn the tide. For physicians it will probably mean venturing several steps outside of their comfort zone. But working shoulder to shoulder with nurses may provide the courage to speak out.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
The time has come for good men and women to unite and rise up against a common foe. For too long nurses and doctors have labored under the tyranny of a dictator who claimed to help them provide high-quality care for their patients while at the same time cutting their paperwork to nil. But like most autocrats he failed to engage his subjects in a meaningful dialogue as each new version of his promised improvements rolled off the drawing board. When the caregivers were slow to adopt these new nonsystems he offered them financial incentives and issued threats to their survival. Although they were warned that there might be uncomfortable adjustment periods, the caregivers were promised that the steep learning curves would level out and their professional lives would again be valued and productive.
Of course, the dictator is not a single person but a motley and disorganized conglomerate of user- and patient-unfriendly electronic health record nonsystems. Ask almost any nurse or physician for her feelings about computer-based medical record systems, and you will hear tales of long hours, disengagement, and frustration. Caregivers are unhappy at all levels, and patients have grown tired of their nurses and physicians spending most of their time looking at computer screens.
You certainly have heard this all before. But you are hearing it in hospital hallways and grocery store checkout lines as a low rumble of discontent emerging from separate individuals, not as a well-articulated and widely distributed voice of physicians as a group. To some extent this relative silence is because there is no such group, at least not in same mold as a labor union. The term “labor union” may make you uncomfortable. But given the current climate in medicine, unionizing may be the best and only way to effect change.
But organizing to effect change in the workplace isn’t part of the physician genome. In the 1960s, a group of house officers in Boston engaged in a heal-in to successfully improve their salaries and working conditions. But over the ensuing half century physicians have remained tragically silent in the face of a changing workplace landscape in which they have gone from being independent owner operators in control of their destinies to becoming employees feeling powerless to improve their working conditions. This perceived impotence has escalated in the face of the challenge posed by the introduction of dysfunctional EHRs.
Ironically, a solution is at almost every physician’s elbow. In a recent New York Times opinion piece Theresa Brown and Stephen Bergman acknowledge that physicians don’t seem prepared to mount a meaningful response to the challenge to the failed promise of EHRs (“Doctors, Nurses and the Paperwork Crisis That Could Unite Them,” Dec. 31, 2019). They point out that, over the last half century, physicians have remained isolated on the sidelines, finding just enough voice to grumble. Nurses have in a variety of situations organized to effect change in their working conditions – in some cases by forming labor unions.
The authors of this op-ed piece, a physician and a nurse, make a strong argument that the time has come for nurses and doctors shake off the shackles of their stereotypic roles and join in creating a loud, forceful, and effective voice to demand a working environment in which the computer functions as an asset and no longer as the terrible burden it has become. Neither group has the power to do it alone, but together they may be able to turn the tide. For physicians it will probably mean venturing several steps outside of their comfort zone. But working shoulder to shoulder with nurses may provide the courage to speak out.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
The time has come for good men and women to unite and rise up against a common foe. For too long nurses and doctors have labored under the tyranny of a dictator who claimed to help them provide high-quality care for their patients while at the same time cutting their paperwork to nil. But like most autocrats he failed to engage his subjects in a meaningful dialogue as each new version of his promised improvements rolled off the drawing board. When the caregivers were slow to adopt these new nonsystems he offered them financial incentives and issued threats to their survival. Although they were warned that there might be uncomfortable adjustment periods, the caregivers were promised that the steep learning curves would level out and their professional lives would again be valued and productive.
Of course, the dictator is not a single person but a motley and disorganized conglomerate of user- and patient-unfriendly electronic health record nonsystems. Ask almost any nurse or physician for her feelings about computer-based medical record systems, and you will hear tales of long hours, disengagement, and frustration. Caregivers are unhappy at all levels, and patients have grown tired of their nurses and physicians spending most of their time looking at computer screens.
You certainly have heard this all before. But you are hearing it in hospital hallways and grocery store checkout lines as a low rumble of discontent emerging from separate individuals, not as a well-articulated and widely distributed voice of physicians as a group. To some extent this relative silence is because there is no such group, at least not in same mold as a labor union. The term “labor union” may make you uncomfortable. But given the current climate in medicine, unionizing may be the best and only way to effect change.
But organizing to effect change in the workplace isn’t part of the physician genome. In the 1960s, a group of house officers in Boston engaged in a heal-in to successfully improve their salaries and working conditions. But over the ensuing half century physicians have remained tragically silent in the face of a changing workplace landscape in which they have gone from being independent owner operators in control of their destinies to becoming employees feeling powerless to improve their working conditions. This perceived impotence has escalated in the face of the challenge posed by the introduction of dysfunctional EHRs.
Ironically, a solution is at almost every physician’s elbow. In a recent New York Times opinion piece Theresa Brown and Stephen Bergman acknowledge that physicians don’t seem prepared to mount a meaningful response to the challenge to the failed promise of EHRs (“Doctors, Nurses and the Paperwork Crisis That Could Unite Them,” Dec. 31, 2019). They point out that, over the last half century, physicians have remained isolated on the sidelines, finding just enough voice to grumble. Nurses have in a variety of situations organized to effect change in their working conditions – in some cases by forming labor unions.
The authors of this op-ed piece, a physician and a nurse, make a strong argument that the time has come for nurses and doctors shake off the shackles of their stereotypic roles and join in creating a loud, forceful, and effective voice to demand a working environment in which the computer functions as an asset and no longer as the terrible burden it has become. Neither group has the power to do it alone, but together they may be able to turn the tide. For physicians it will probably mean venturing several steps outside of their comfort zone. But working shoulder to shoulder with nurses may provide the courage to speak out.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
What to do when stimulants fail for ADHD
NEW ORLEANS – A variety of reasons can contribute to the failure of stimulants to treat ADHD in children, such as comorbidities, missed diagnoses, inadequate medication dosage, side effects, major life changes, and other factors in the home or school environments, said Alison Schonwald, MD, of Harvard Medical School, Boston.
Stimulant medications indicated for ADHD usually work in 70%-75% of school-age children, but that leaves one in four children whose condition can be more challenging to treat, she said.
“Look around you,” Dr. Schonwald told a packed room at the annual meeting of the American Academy of Pediatrics. “You’re not the only one struggling with this topic.” She sprinkled her presentation with case studies of patients with ADHD for whom stimulants weren’t working, examples that the audience clearly found familiar.
The three steps you already know to do with treatment-resistant children sound simple: assess the child for factors linked to their poor response; develop a new treatment plan; and use Food and Drug Administration-approved nonstimulant medications, including off-label options, in a new plan.
But in the office, the process can be anything but simple when you must consider school and family environments, comorbidities, and other factors potentially complicating the child’s ability to function well.
Comorbidities
To start, Dr. Schonwald provided a chart of common coexisting problems in children with ADHD that included the recommended assessment and intervention:
- Mood and self-esteem issues call for the depression section of the patient health questionnaire (PHQ9) and Moods and Feelings questionnaire (MFQ), followed by interventions such as individual and peer group therapy and exercise.
- Anxiety can be assessed with the Screen for Child Anxiety Related Disorders (SCARED) and Spence Children’s Anxiety Scale, then treated similarly to mood and self-esteem issues.
- Bullying or trauma require taking a history during an interview, and treatment with individual and peer group therapy.
- Substance abuse should be assessed with the CRAFFT screening tool (Car, Relax, Alone, Forget, Friends, Trouble) and Screening to Brief Intervention (S2BI) Tool, then treated according to best practices.
- Executive function, low cognitive abilities, and poor adaptive skills require a review of the child’s Individualized Education Program (IEP) testing, followed by personalized school and home interventions.
- Poor social skills, assessed in an interview, also require personalized interventions at home and in school.
Doctors also may need to consider other common comorbidities in children with ADHD, such as bipolar disorder, depression, learning disabilities, oppositional defiant disorder, and tic disorders.
Tic disorders typically have an onset around 7 years old and peak in midadolescence, declining in late teen years. An estimated 35%-90% of children with Tourette syndrome have ADHD, Dr. Schonwald said (Dev Med Child Neurol. 2006 Jul;48[7]:616-21).
Managing treatment with stimulants
A common dosage amount for stimulants is 2.5-5 mg, but that dose may be too low for children, Dr. Schonwald said. She recommended increasing it until an effect is seen and stopping at the effective dose level the child can tolerate. The maximum recommended by the FDA is 60 mg/day for short-acting stimulants and 72 mg/day for extended-release ones, but some research has shown dosage can go even higher without causing toxic effects (J Child Adolesc Psychopharmacol. 2010 Feb;20[1]:49-54).
Dr. Schonwald also suggested trying both methylphenidate and amphetamine medication, while recognizing the latter tends to have more stimulant-related side effects.
Adherence is another consideration because multiple studies show high rates of noncompliance or discontinuation, such as up to 19% discontinuation for long-acting and 38% for short-acting stimulants (J Clin Psychiatry. 2015 Nov;76(11):e1459-68; Postgrad Med. 2012 May;124(3):139-48). A study of a school cohort in Philadelphia found only about one in five children were adherent (J Am Acad Child Adolesc Psychiatry. 2011 May;50[5]:480-9).
One potential solution to adherence challenges are pill reminder smartphone apps, such as Medisafe Medication Management, Pill Reminder-All in One, MyTherapy: Medication Reminder, and CareZone.
Dr. Schonwald noted several factors that can influence children’s response to stimulants. Among children with comorbid intellectual disability, for example, the response rate is lower than the average 75% of children without the disability, hovering around 40%-50% (Res Dev Disabil. 2018 Dec;83:217-32). Those who get more sleep tend to have improved attention, compared with children with less sleep (Atten Defic Hyperact Disord. 2017 Mar;9[1]:31-38).
She also offered strategies to manage problematic adverse effects from stimulants. Those experiencing weight loss can take their stimulant after breakfast, drink whole milk, and consider taking drug holidays.
To reduce stomachaches, children should take their medication with food, and you should look at whether the child is taking the lowest effective dose they can and whether anxiety may be involved. Similarly, children with headaches should take stimulants with food, and you should look at the dosage and ask whether the patient is getting adequate sleep.
Strategies to address difficulty falling asleep can include taking the stimulant earlier in the day or switching to a shorter-acting form, dexmethylphenidate, or another stimulant. If they’re having trouble staying asleep, inquire about sleep hygiene, and look for associations with other factors that might explain why the child is experiencing new problems with staying asleep. If these strategies are unsuccessful, you can consider prescribing melatonin or clonidine.
Alternatives to stimulants
Several medications besides stimulants are available to prescribe to children with ADHD if they aren’t responding adequately to stimulants, Dr. Schonwald said.
Atomoxetine performed better than placebo in treatment studies, with similar weight loss effects, albeit the lowest mean effect size in clinician ratings (Lancet Psychiatry. 2018 Sep;5[9]:727-38). Dr. Schonwald recommended starting atomoxetine in children under 40 kg at 0.5 mg/kg for 4 days, then increasing to 1.2 mg/kg/day. For children over 40 kg, the dose can start at 40 mg. Maximum dose can range from 1.4 to 1.8 mg/kg or 100 mg/day.
About 7% of white children and 2% of African American children are poor metabolizers of atomoxetine, and the drug has interactions with dextromethorphan, fluoxetine, and paroxetine, she noted. Side effects can include abdominal pain, dry mouth, fatigue, mood swings, nausea, and vomiting.
Two alpha-adrenergics that you can consider are clonidine and guanfacine. Clonidine, a hypotensive drug given at a dose of 0.05-0.2 mg up to three times a day, is helpful for hyperactivity and impulsivity rather than attention difficulties. Side effects can include depression, headache, rebound hypertension, and sedation, and it’s only FDA approved for ages 12 years and older.
An extended release version of clonidine (Kapvay) is approved for monotherapy or adjunctive therapy for ADHD; it led to improvements in ADHD–Rating Scale-IV scores as soon as the second week in an 8-week randomized controlled trial. Mild to moderate somnolence was the most common adverse event, and changes on electrocardiograms were minor (J Am Acad Child Adolesc Psychiatry. 2011 Feb;50[2]:171-9).
Guanfacine, also a hypotensive drug, given at a dose of 0.5-2 mg up to three times a day, has fewer data about its use for ADHD but appears to treat attention problems more effectively than hyperactivity. Also approved only for ages 12 years and older, guanfacine is less sedating, and its side effects can include agitation, headache , and insomnia. An extended-release version of guanfacine (brand name Intuniv) showed statistically significant reductions in ADHD Rating Scale-IV scores in a 9-week, double-blind, randomized, controlled trial. Side effects including fatigue, sedation, and somnolence occurred in the first 2 weeks but generally resolved, and participants returned to baseline during dose maintenance and tapering (J Am Acad Child Adolesc Psychiatry. 2009 Feb;48[2]:155-65).
Intuniv doses should start at 1 mg/day and increase no more than 1 mg/week, Dr. Schonwald said, until reaching a maintenance dose of 1-4 mg once daily, depending on the patient’s clinical response and tolerability. Children also must be able to swallow the pill whole.
Treating preschoolers
Preschool children are particularly difficult to diagnose given their normal range of temperament and development, Dr. Schonwald said. Their symptoms could be resulting from another diagnosis or from circumstances in the environment.
You should consider potential comorbidities and whether the child’s symptoms are situational or pervasive. About 55% of preschoolers have at least one comorbidity, she said (Infants & Young Children. 2006 Apr-Jun;19[2]:109-122.)
That said, stimulants usually are effective in very young children whose primary concern is ADHD. In a randomized controlled trial of 303 preschoolers, significantly more children experienced reduced ADHD symptoms with methylphenidate than with placebo. The trial’s “data suggest that preschoolers with ADHD need to start with low methylphenidate doses. Treatment may best begin using methylphenidate–immediate release at 2.5 mg twice daily, and then be increased to 7.5 mg three times a day during the course of 1 week. The mean optimal total daily [methylphenidate] dose for preschoolers was 14.2 plus or minus 8.1 mg/day” (J Am Acad Child Adolesc Psychiatry. 2006 Nov;45[11]:1284-93).
In treating preschoolers, if the patient’s symptoms appear to get worse after starting a stimulant, you can consider a medication change. If symptoms are much worse, consider a lower dose or a different stimulant class, or whether the diagnosis is appropriate.
Five common components of poor behavior in preschoolers with ADHD include agitation, anxiety, explosively, hyperactivity, and impulsivity. If these issues are occurring throughout the day, consider reducing the dose or switching drug classes.
If it’s only occurring in the morning, Dr. Schonwald said, optimize the morning structure and consider giving the medication earlier in the morning or adding a short-acting booster. If it’s occurring in late afternoon, consider a booster and reducing high-demand activities for the child.
If a preschooler experiences some benefit from the stimulant but still has problems, adjunctive atomoxetine or an alpha adrenergic may help. Those medications also are recommended if the child has no benefit with the stimulant or cannot tolerate the lowest therapeutic dose.
Dr. Schonwald said she had no relevant financial disclosures.
NEW ORLEANS – A variety of reasons can contribute to the failure of stimulants to treat ADHD in children, such as comorbidities, missed diagnoses, inadequate medication dosage, side effects, major life changes, and other factors in the home or school environments, said Alison Schonwald, MD, of Harvard Medical School, Boston.
Stimulant medications indicated for ADHD usually work in 70%-75% of school-age children, but that leaves one in four children whose condition can be more challenging to treat, she said.
“Look around you,” Dr. Schonwald told a packed room at the annual meeting of the American Academy of Pediatrics. “You’re not the only one struggling with this topic.” She sprinkled her presentation with case studies of patients with ADHD for whom stimulants weren’t working, examples that the audience clearly found familiar.
The three steps you already know to do with treatment-resistant children sound simple: assess the child for factors linked to their poor response; develop a new treatment plan; and use Food and Drug Administration-approved nonstimulant medications, including off-label options, in a new plan.
But in the office, the process can be anything but simple when you must consider school and family environments, comorbidities, and other factors potentially complicating the child’s ability to function well.
Comorbidities
To start, Dr. Schonwald provided a chart of common coexisting problems in children with ADHD that included the recommended assessment and intervention:
- Mood and self-esteem issues call for the depression section of the patient health questionnaire (PHQ9) and Moods and Feelings questionnaire (MFQ), followed by interventions such as individual and peer group therapy and exercise.
- Anxiety can be assessed with the Screen for Child Anxiety Related Disorders (SCARED) and Spence Children’s Anxiety Scale, then treated similarly to mood and self-esteem issues.
- Bullying or trauma require taking a history during an interview, and treatment with individual and peer group therapy.
- Substance abuse should be assessed with the CRAFFT screening tool (Car, Relax, Alone, Forget, Friends, Trouble) and Screening to Brief Intervention (S2BI) Tool, then treated according to best practices.
- Executive function, low cognitive abilities, and poor adaptive skills require a review of the child’s Individualized Education Program (IEP) testing, followed by personalized school and home interventions.
- Poor social skills, assessed in an interview, also require personalized interventions at home and in school.
Doctors also may need to consider other common comorbidities in children with ADHD, such as bipolar disorder, depression, learning disabilities, oppositional defiant disorder, and tic disorders.
Tic disorders typically have an onset around 7 years old and peak in midadolescence, declining in late teen years. An estimated 35%-90% of children with Tourette syndrome have ADHD, Dr. Schonwald said (Dev Med Child Neurol. 2006 Jul;48[7]:616-21).
Managing treatment with stimulants
A common dosage amount for stimulants is 2.5-5 mg, but that dose may be too low for children, Dr. Schonwald said. She recommended increasing it until an effect is seen and stopping at the effective dose level the child can tolerate. The maximum recommended by the FDA is 60 mg/day for short-acting stimulants and 72 mg/day for extended-release ones, but some research has shown dosage can go even higher without causing toxic effects (J Child Adolesc Psychopharmacol. 2010 Feb;20[1]:49-54).
Dr. Schonwald also suggested trying both methylphenidate and amphetamine medication, while recognizing the latter tends to have more stimulant-related side effects.
Adherence is another consideration because multiple studies show high rates of noncompliance or discontinuation, such as up to 19% discontinuation for long-acting and 38% for short-acting stimulants (J Clin Psychiatry. 2015 Nov;76(11):e1459-68; Postgrad Med. 2012 May;124(3):139-48). A study of a school cohort in Philadelphia found only about one in five children were adherent (J Am Acad Child Adolesc Psychiatry. 2011 May;50[5]:480-9).
One potential solution to adherence challenges are pill reminder smartphone apps, such as Medisafe Medication Management, Pill Reminder-All in One, MyTherapy: Medication Reminder, and CareZone.
Dr. Schonwald noted several factors that can influence children’s response to stimulants. Among children with comorbid intellectual disability, for example, the response rate is lower than the average 75% of children without the disability, hovering around 40%-50% (Res Dev Disabil. 2018 Dec;83:217-32). Those who get more sleep tend to have improved attention, compared with children with less sleep (Atten Defic Hyperact Disord. 2017 Mar;9[1]:31-38).
She also offered strategies to manage problematic adverse effects from stimulants. Those experiencing weight loss can take their stimulant after breakfast, drink whole milk, and consider taking drug holidays.
To reduce stomachaches, children should take their medication with food, and you should look at whether the child is taking the lowest effective dose they can and whether anxiety may be involved. Similarly, children with headaches should take stimulants with food, and you should look at the dosage and ask whether the patient is getting adequate sleep.
Strategies to address difficulty falling asleep can include taking the stimulant earlier in the day or switching to a shorter-acting form, dexmethylphenidate, or another stimulant. If they’re having trouble staying asleep, inquire about sleep hygiene, and look for associations with other factors that might explain why the child is experiencing new problems with staying asleep. If these strategies are unsuccessful, you can consider prescribing melatonin or clonidine.
Alternatives to stimulants
Several medications besides stimulants are available to prescribe to children with ADHD if they aren’t responding adequately to stimulants, Dr. Schonwald said.
Atomoxetine performed better than placebo in treatment studies, with similar weight loss effects, albeit the lowest mean effect size in clinician ratings (Lancet Psychiatry. 2018 Sep;5[9]:727-38). Dr. Schonwald recommended starting atomoxetine in children under 40 kg at 0.5 mg/kg for 4 days, then increasing to 1.2 mg/kg/day. For children over 40 kg, the dose can start at 40 mg. Maximum dose can range from 1.4 to 1.8 mg/kg or 100 mg/day.
About 7% of white children and 2% of African American children are poor metabolizers of atomoxetine, and the drug has interactions with dextromethorphan, fluoxetine, and paroxetine, she noted. Side effects can include abdominal pain, dry mouth, fatigue, mood swings, nausea, and vomiting.
Two alpha-adrenergics that you can consider are clonidine and guanfacine. Clonidine, a hypotensive drug given at a dose of 0.05-0.2 mg up to three times a day, is helpful for hyperactivity and impulsivity rather than attention difficulties. Side effects can include depression, headache, rebound hypertension, and sedation, and it’s only FDA approved for ages 12 years and older.
An extended release version of clonidine (Kapvay) is approved for monotherapy or adjunctive therapy for ADHD; it led to improvements in ADHD–Rating Scale-IV scores as soon as the second week in an 8-week randomized controlled trial. Mild to moderate somnolence was the most common adverse event, and changes on electrocardiograms were minor (J Am Acad Child Adolesc Psychiatry. 2011 Feb;50[2]:171-9).
Guanfacine, also a hypotensive drug, given at a dose of 0.5-2 mg up to three times a day, has fewer data about its use for ADHD but appears to treat attention problems more effectively than hyperactivity. Also approved only for ages 12 years and older, guanfacine is less sedating, and its side effects can include agitation, headache , and insomnia. An extended-release version of guanfacine (brand name Intuniv) showed statistically significant reductions in ADHD Rating Scale-IV scores in a 9-week, double-blind, randomized, controlled trial. Side effects including fatigue, sedation, and somnolence occurred in the first 2 weeks but generally resolved, and participants returned to baseline during dose maintenance and tapering (J Am Acad Child Adolesc Psychiatry. 2009 Feb;48[2]:155-65).
Intuniv doses should start at 1 mg/day and increase no more than 1 mg/week, Dr. Schonwald said, until reaching a maintenance dose of 1-4 mg once daily, depending on the patient’s clinical response and tolerability. Children also must be able to swallow the pill whole.
Treating preschoolers
Preschool children are particularly difficult to diagnose given their normal range of temperament and development, Dr. Schonwald said. Their symptoms could be resulting from another diagnosis or from circumstances in the environment.
You should consider potential comorbidities and whether the child’s symptoms are situational or pervasive. About 55% of preschoolers have at least one comorbidity, she said (Infants & Young Children. 2006 Apr-Jun;19[2]:109-122.)
That said, stimulants usually are effective in very young children whose primary concern is ADHD. In a randomized controlled trial of 303 preschoolers, significantly more children experienced reduced ADHD symptoms with methylphenidate than with placebo. The trial’s “data suggest that preschoolers with ADHD need to start with low methylphenidate doses. Treatment may best begin using methylphenidate–immediate release at 2.5 mg twice daily, and then be increased to 7.5 mg three times a day during the course of 1 week. The mean optimal total daily [methylphenidate] dose for preschoolers was 14.2 plus or minus 8.1 mg/day” (J Am Acad Child Adolesc Psychiatry. 2006 Nov;45[11]:1284-93).
In treating preschoolers, if the patient’s symptoms appear to get worse after starting a stimulant, you can consider a medication change. If symptoms are much worse, consider a lower dose or a different stimulant class, or whether the diagnosis is appropriate.
Five common components of poor behavior in preschoolers with ADHD include agitation, anxiety, explosively, hyperactivity, and impulsivity. If these issues are occurring throughout the day, consider reducing the dose or switching drug classes.
If it’s only occurring in the morning, Dr. Schonwald said, optimize the morning structure and consider giving the medication earlier in the morning or adding a short-acting booster. If it’s occurring in late afternoon, consider a booster and reducing high-demand activities for the child.
If a preschooler experiences some benefit from the stimulant but still has problems, adjunctive atomoxetine or an alpha adrenergic may help. Those medications also are recommended if the child has no benefit with the stimulant or cannot tolerate the lowest therapeutic dose.
Dr. Schonwald said she had no relevant financial disclosures.
NEW ORLEANS – A variety of reasons can contribute to the failure of stimulants to treat ADHD in children, such as comorbidities, missed diagnoses, inadequate medication dosage, side effects, major life changes, and other factors in the home or school environments, said Alison Schonwald, MD, of Harvard Medical School, Boston.
Stimulant medications indicated for ADHD usually work in 70%-75% of school-age children, but that leaves one in four children whose condition can be more challenging to treat, she said.
“Look around you,” Dr. Schonwald told a packed room at the annual meeting of the American Academy of Pediatrics. “You’re not the only one struggling with this topic.” She sprinkled her presentation with case studies of patients with ADHD for whom stimulants weren’t working, examples that the audience clearly found familiar.
The three steps you already know to do with treatment-resistant children sound simple: assess the child for factors linked to their poor response; develop a new treatment plan; and use Food and Drug Administration-approved nonstimulant medications, including off-label options, in a new plan.
But in the office, the process can be anything but simple when you must consider school and family environments, comorbidities, and other factors potentially complicating the child’s ability to function well.
Comorbidities
To start, Dr. Schonwald provided a chart of common coexisting problems in children with ADHD that included the recommended assessment and intervention:
- Mood and self-esteem issues call for the depression section of the patient health questionnaire (PHQ9) and Moods and Feelings questionnaire (MFQ), followed by interventions such as individual and peer group therapy and exercise.
- Anxiety can be assessed with the Screen for Child Anxiety Related Disorders (SCARED) and Spence Children’s Anxiety Scale, then treated similarly to mood and self-esteem issues.
- Bullying or trauma require taking a history during an interview, and treatment with individual and peer group therapy.
- Substance abuse should be assessed with the CRAFFT screening tool (Car, Relax, Alone, Forget, Friends, Trouble) and Screening to Brief Intervention (S2BI) Tool, then treated according to best practices.
- Executive function, low cognitive abilities, and poor adaptive skills require a review of the child’s Individualized Education Program (IEP) testing, followed by personalized school and home interventions.
- Poor social skills, assessed in an interview, also require personalized interventions at home and in school.
Doctors also may need to consider other common comorbidities in children with ADHD, such as bipolar disorder, depression, learning disabilities, oppositional defiant disorder, and tic disorders.
Tic disorders typically have an onset around 7 years old and peak in midadolescence, declining in late teen years. An estimated 35%-90% of children with Tourette syndrome have ADHD, Dr. Schonwald said (Dev Med Child Neurol. 2006 Jul;48[7]:616-21).
Managing treatment with stimulants
A common dosage amount for stimulants is 2.5-5 mg, but that dose may be too low for children, Dr. Schonwald said. She recommended increasing it until an effect is seen and stopping at the effective dose level the child can tolerate. The maximum recommended by the FDA is 60 mg/day for short-acting stimulants and 72 mg/day for extended-release ones, but some research has shown dosage can go even higher without causing toxic effects (J Child Adolesc Psychopharmacol. 2010 Feb;20[1]:49-54).
Dr. Schonwald also suggested trying both methylphenidate and amphetamine medication, while recognizing the latter tends to have more stimulant-related side effects.
Adherence is another consideration because multiple studies show high rates of noncompliance or discontinuation, such as up to 19% discontinuation for long-acting and 38% for short-acting stimulants (J Clin Psychiatry. 2015 Nov;76(11):e1459-68; Postgrad Med. 2012 May;124(3):139-48). A study of a school cohort in Philadelphia found only about one in five children were adherent (J Am Acad Child Adolesc Psychiatry. 2011 May;50[5]:480-9).
One potential solution to adherence challenges are pill reminder smartphone apps, such as Medisafe Medication Management, Pill Reminder-All in One, MyTherapy: Medication Reminder, and CareZone.
Dr. Schonwald noted several factors that can influence children’s response to stimulants. Among children with comorbid intellectual disability, for example, the response rate is lower than the average 75% of children without the disability, hovering around 40%-50% (Res Dev Disabil. 2018 Dec;83:217-32). Those who get more sleep tend to have improved attention, compared with children with less sleep (Atten Defic Hyperact Disord. 2017 Mar;9[1]:31-38).
She also offered strategies to manage problematic adverse effects from stimulants. Those experiencing weight loss can take their stimulant after breakfast, drink whole milk, and consider taking drug holidays.
To reduce stomachaches, children should take their medication with food, and you should look at whether the child is taking the lowest effective dose they can and whether anxiety may be involved. Similarly, children with headaches should take stimulants with food, and you should look at the dosage and ask whether the patient is getting adequate sleep.
Strategies to address difficulty falling asleep can include taking the stimulant earlier in the day or switching to a shorter-acting form, dexmethylphenidate, or another stimulant. If they’re having trouble staying asleep, inquire about sleep hygiene, and look for associations with other factors that might explain why the child is experiencing new problems with staying asleep. If these strategies are unsuccessful, you can consider prescribing melatonin or clonidine.
Alternatives to stimulants
Several medications besides stimulants are available to prescribe to children with ADHD if they aren’t responding adequately to stimulants, Dr. Schonwald said.
Atomoxetine performed better than placebo in treatment studies, with similar weight loss effects, albeit the lowest mean effect size in clinician ratings (Lancet Psychiatry. 2018 Sep;5[9]:727-38). Dr. Schonwald recommended starting atomoxetine in children under 40 kg at 0.5 mg/kg for 4 days, then increasing to 1.2 mg/kg/day. For children over 40 kg, the dose can start at 40 mg. Maximum dose can range from 1.4 to 1.8 mg/kg or 100 mg/day.
About 7% of white children and 2% of African American children are poor metabolizers of atomoxetine, and the drug has interactions with dextromethorphan, fluoxetine, and paroxetine, she noted. Side effects can include abdominal pain, dry mouth, fatigue, mood swings, nausea, and vomiting.
Two alpha-adrenergics that you can consider are clonidine and guanfacine. Clonidine, a hypotensive drug given at a dose of 0.05-0.2 mg up to three times a day, is helpful for hyperactivity and impulsivity rather than attention difficulties. Side effects can include depression, headache, rebound hypertension, and sedation, and it’s only FDA approved for ages 12 years and older.
An extended release version of clonidine (Kapvay) is approved for monotherapy or adjunctive therapy for ADHD; it led to improvements in ADHD–Rating Scale-IV scores as soon as the second week in an 8-week randomized controlled trial. Mild to moderate somnolence was the most common adverse event, and changes on electrocardiograms were minor (J Am Acad Child Adolesc Psychiatry. 2011 Feb;50[2]:171-9).
Guanfacine, also a hypotensive drug, given at a dose of 0.5-2 mg up to three times a day, has fewer data about its use for ADHD but appears to treat attention problems more effectively than hyperactivity. Also approved only for ages 12 years and older, guanfacine is less sedating, and its side effects can include agitation, headache , and insomnia. An extended-release version of guanfacine (brand name Intuniv) showed statistically significant reductions in ADHD Rating Scale-IV scores in a 9-week, double-blind, randomized, controlled trial. Side effects including fatigue, sedation, and somnolence occurred in the first 2 weeks but generally resolved, and participants returned to baseline during dose maintenance and tapering (J Am Acad Child Adolesc Psychiatry. 2009 Feb;48[2]:155-65).
Intuniv doses should start at 1 mg/day and increase no more than 1 mg/week, Dr. Schonwald said, until reaching a maintenance dose of 1-4 mg once daily, depending on the patient’s clinical response and tolerability. Children also must be able to swallow the pill whole.
Treating preschoolers
Preschool children are particularly difficult to diagnose given their normal range of temperament and development, Dr. Schonwald said. Their symptoms could be resulting from another diagnosis or from circumstances in the environment.
You should consider potential comorbidities and whether the child’s symptoms are situational or pervasive. About 55% of preschoolers have at least one comorbidity, she said (Infants & Young Children. 2006 Apr-Jun;19[2]:109-122.)
That said, stimulants usually are effective in very young children whose primary concern is ADHD. In a randomized controlled trial of 303 preschoolers, significantly more children experienced reduced ADHD symptoms with methylphenidate than with placebo. The trial’s “data suggest that preschoolers with ADHD need to start with low methylphenidate doses. Treatment may best begin using methylphenidate–immediate release at 2.5 mg twice daily, and then be increased to 7.5 mg three times a day during the course of 1 week. The mean optimal total daily [methylphenidate] dose for preschoolers was 14.2 plus or minus 8.1 mg/day” (J Am Acad Child Adolesc Psychiatry. 2006 Nov;45[11]:1284-93).
In treating preschoolers, if the patient’s symptoms appear to get worse after starting a stimulant, you can consider a medication change. If symptoms are much worse, consider a lower dose or a different stimulant class, or whether the diagnosis is appropriate.
Five common components of poor behavior in preschoolers with ADHD include agitation, anxiety, explosively, hyperactivity, and impulsivity. If these issues are occurring throughout the day, consider reducing the dose or switching drug classes.
If it’s only occurring in the morning, Dr. Schonwald said, optimize the morning structure and consider giving the medication earlier in the morning or adding a short-acting booster. If it’s occurring in late afternoon, consider a booster and reducing high-demand activities for the child.
If a preschooler experiences some benefit from the stimulant but still has problems, adjunctive atomoxetine or an alpha adrenergic may help. Those medications also are recommended if the child has no benefit with the stimulant or cannot tolerate the lowest therapeutic dose.
Dr. Schonwald said she had no relevant financial disclosures.
EXPERT ANALYSIS FROM AAP 2019
Delaying flu vaccine didn’t drop fever rate for childhood immunizations
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
FROM PEDIATRICS
Key clinical point: Fevers were no less common when influenza vaccine was delayed for children receiving DTaP and pneumococcal vaccinations.
Major finding: There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87).
Study details: Randomized, nonblinded trial of 221 children aged 12-16 months receiving scheduled vaccinations.
Disclosures: The study was funded by the Centers for Disease Control and Prevention. One coauthor reported financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune.
Source: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
CDC begins coronavirus diagnostic test kit distribution; new case confirmed in Wisconsin
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
Is primary care relevant?
You probably still remember your pediatrician. Your relationship with her may have influenced your decision to become a physician. She was your parents’ go-to source for pretty much anything to do with your health. You had a primary care physician in large part because your parents felt that children were particularly vulnerable to disease and wanted to avoid any missteps on your road to maturity. On the other hand, while you were growing up your parents probably were much less concerned about their own health. Their peers and friends seemed healthy enough; why would they need annual checkups? Your folks made sure they had life insurance because accidental death and injury felt like more pressing concerns. If they had a primary physician, they may have visited him infrequently. They may have been more likely to visit their dentist, in part because the office put a strong emphasis on the value of preventive care.
A recent survey from Harvard Medical School, Boston, determined that, in 2015, 75% of adult Americans had an established source of primary care. (“Fewer Americans are getting primary care,” Jake Miller, the Harvard Gazette, Dec. 16, 2019). This number sounds pretty good and not unexpected until you learn that in 2002 that number was 77%. While 2% seems like a drop in the bucket, remember we live in a very populous bucket, and that 2% translates to millions fewer Americans who are not receiving primary care than did more than a decade ago.
While the researchers don’t have data to explain the decline in primary care, they suggest raising the pay of primary care physicians, incentivizing rural practice, and making health insurance more available and affordable as solutions. Of course these recommendations are not surprising. We’ve heard them before. More supply might translate into more usage. But could some of the decline in primary care be because it no longer feels relevant to a population that has become accustomed to instant gratification? One click and the thing you didn’t feel like waiting for in line today is on your doorstep tomorrow, or even sooner.
If we want to create meaningful change, we need to learn a thing or two about marketing from the competition and from the successful businesses who are shaping consumer behavior. It’s not surprising that, when people feel healthy (whether they are or not), they will devalue primary care. But if they sprain an ankle or have a cough that is keeping them up at night, they would like some medical attention ... now. And that will drive them away from primary care toward sources of fragmented care – the doc-in-the-box, the walk-in clinic, or even more unfortunately to the local emergency department.
If we want more people to establish relationships with primary care providers, we need to welcome them in the door ... when they feel a need. Once in the door we can establish rapport and show them there is a value to primary care while they are feeling grateful for the prompt attention we gave them. But too many primary care practices are shunting potential patients into fragmented care by appearing unwelcome to minor emergencies and by creating customer-unfriendly communication networks. Most people I know would be happy to go back to the old days of “take two aspirin and call me in the morning” primary care. At least you had talked to a doctor in real time, and you knew that he or she would see you the next day if you still had a problem.
You may think I’ve suddenly gone utopian. But there are ways to run a practice that welcomes patients with minor complaints on short notice. It requires some flexibility, some willingness to work longer on some days, and being more efficient.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
You probably still remember your pediatrician. Your relationship with her may have influenced your decision to become a physician. She was your parents’ go-to source for pretty much anything to do with your health. You had a primary care physician in large part because your parents felt that children were particularly vulnerable to disease and wanted to avoid any missteps on your road to maturity. On the other hand, while you were growing up your parents probably were much less concerned about their own health. Their peers and friends seemed healthy enough; why would they need annual checkups? Your folks made sure they had life insurance because accidental death and injury felt like more pressing concerns. If they had a primary physician, they may have visited him infrequently. They may have been more likely to visit their dentist, in part because the office put a strong emphasis on the value of preventive care.
A recent survey from Harvard Medical School, Boston, determined that, in 2015, 75% of adult Americans had an established source of primary care. (“Fewer Americans are getting primary care,” Jake Miller, the Harvard Gazette, Dec. 16, 2019). This number sounds pretty good and not unexpected until you learn that in 2002 that number was 77%. While 2% seems like a drop in the bucket, remember we live in a very populous bucket, and that 2% translates to millions fewer Americans who are not receiving primary care than did more than a decade ago.
While the researchers don’t have data to explain the decline in primary care, they suggest raising the pay of primary care physicians, incentivizing rural practice, and making health insurance more available and affordable as solutions. Of course these recommendations are not surprising. We’ve heard them before. More supply might translate into more usage. But could some of the decline in primary care be because it no longer feels relevant to a population that has become accustomed to instant gratification? One click and the thing you didn’t feel like waiting for in line today is on your doorstep tomorrow, or even sooner.
If we want to create meaningful change, we need to learn a thing or two about marketing from the competition and from the successful businesses who are shaping consumer behavior. It’s not surprising that, when people feel healthy (whether they are or not), they will devalue primary care. But if they sprain an ankle or have a cough that is keeping them up at night, they would like some medical attention ... now. And that will drive them away from primary care toward sources of fragmented care – the doc-in-the-box, the walk-in clinic, or even more unfortunately to the local emergency department.
If we want more people to establish relationships with primary care providers, we need to welcome them in the door ... when they feel a need. Once in the door we can establish rapport and show them there is a value to primary care while they are feeling grateful for the prompt attention we gave them. But too many primary care practices are shunting potential patients into fragmented care by appearing unwelcome to minor emergencies and by creating customer-unfriendly communication networks. Most people I know would be happy to go back to the old days of “take two aspirin and call me in the morning” primary care. At least you had talked to a doctor in real time, and you knew that he or she would see you the next day if you still had a problem.
You may think I’ve suddenly gone utopian. But there are ways to run a practice that welcomes patients with minor complaints on short notice. It requires some flexibility, some willingness to work longer on some days, and being more efficient.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
You probably still remember your pediatrician. Your relationship with her may have influenced your decision to become a physician. She was your parents’ go-to source for pretty much anything to do with your health. You had a primary care physician in large part because your parents felt that children were particularly vulnerable to disease and wanted to avoid any missteps on your road to maturity. On the other hand, while you were growing up your parents probably were much less concerned about their own health. Their peers and friends seemed healthy enough; why would they need annual checkups? Your folks made sure they had life insurance because accidental death and injury felt like more pressing concerns. If they had a primary physician, they may have visited him infrequently. They may have been more likely to visit their dentist, in part because the office put a strong emphasis on the value of preventive care.
A recent survey from Harvard Medical School, Boston, determined that, in 2015, 75% of adult Americans had an established source of primary care. (“Fewer Americans are getting primary care,” Jake Miller, the Harvard Gazette, Dec. 16, 2019). This number sounds pretty good and not unexpected until you learn that in 2002 that number was 77%. While 2% seems like a drop in the bucket, remember we live in a very populous bucket, and that 2% translates to millions fewer Americans who are not receiving primary care than did more than a decade ago.
While the researchers don’t have data to explain the decline in primary care, they suggest raising the pay of primary care physicians, incentivizing rural practice, and making health insurance more available and affordable as solutions. Of course these recommendations are not surprising. We’ve heard them before. More supply might translate into more usage. But could some of the decline in primary care be because it no longer feels relevant to a population that has become accustomed to instant gratification? One click and the thing you didn’t feel like waiting for in line today is on your doorstep tomorrow, or even sooner.
If we want to create meaningful change, we need to learn a thing or two about marketing from the competition and from the successful businesses who are shaping consumer behavior. It’s not surprising that, when people feel healthy (whether they are or not), they will devalue primary care. But if they sprain an ankle or have a cough that is keeping them up at night, they would like some medical attention ... now. And that will drive them away from primary care toward sources of fragmented care – the doc-in-the-box, the walk-in clinic, or even more unfortunately to the local emergency department.
If we want more people to establish relationships with primary care providers, we need to welcome them in the door ... when they feel a need. Once in the door we can establish rapport and show them there is a value to primary care while they are feeling grateful for the prompt attention we gave them. But too many primary care practices are shunting potential patients into fragmented care by appearing unwelcome to minor emergencies and by creating customer-unfriendly communication networks. Most people I know would be happy to go back to the old days of “take two aspirin and call me in the morning” primary care. At least you had talked to a doctor in real time, and you knew that he or she would see you the next day if you still had a problem.
You may think I’ve suddenly gone utopian. But there are ways to run a practice that welcomes patients with minor complaints on short notice. It requires some flexibility, some willingness to work longer on some days, and being more efficient.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
Trump takes on multiple health topics in State of the Union
President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.
Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”
That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.
A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.
But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.
“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.
A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.
The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.
The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.
“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”
Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.
Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.
Preexisting conditions
The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.
“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.
In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.
During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.
“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.
Socialist takeover
Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.
“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.
He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”
Added Mr. Trump: “We will never let socialism destroy American health care!”
Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.
Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
Opioids, the coronavirus, and abortion
In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.
He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.
Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.
The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.
“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.
Insulin costs?
In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.
At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.
But Mr. Trump never mentioned insulin in his speech.
This article first appeared on Medscape.com.
President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.
Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”
That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.
A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.
But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.
“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.
A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.
The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.
The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.
“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”
Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.
Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.
Preexisting conditions
The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.
“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.
In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.
During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.
“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.
Socialist takeover
Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.
“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.
He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”
Added Mr. Trump: “We will never let socialism destroy American health care!”
Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.
Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
Opioids, the coronavirus, and abortion
In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.
He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.
Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.
The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.
“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.
Insulin costs?
In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.
At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.
But Mr. Trump never mentioned insulin in his speech.
This article first appeared on Medscape.com.
President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.
Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”
That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.
A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.
But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.
“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.
A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.
The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.
The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.
“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”
Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.
Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.
Preexisting conditions
The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.
“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.
In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.
During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.
“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.
Socialist takeover
Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.
“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.
He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”
Added Mr. Trump: “We will never let socialism destroy American health care!”
Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.
Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
Opioids, the coronavirus, and abortion
In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.
He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.
Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.
The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.
“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.
Insulin costs?
In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.
At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.
But Mr. Trump never mentioned insulin in his speech.
This article first appeared on Medscape.com.