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WHO to push for public ban of e-cigarettes
The use of electronic cigarettes, like that of their tobacco-containing cousins, should be banned in public indoor spaces, the World Health Organization recommends.
Users of electronic nicotine delivery systems devices (ENDS), such as e-cigarettes, should "be legally requested not to use ENDS indoors, especially where smoking is banned, until exhaled vapor is proved to be not harmful to bystanders and reasonable evidence exists that smoke-free policy enforcement is not undermined," according to a WHO report published Aug. 26.
The report is intended to provide a framework for governments to follow when developing regulations around e-cigarettes. It is on the agenda for the upcoming 6th Conference of the Parties to the WHO Framework Convention on Tobacco Control in Moscow Oct. 13-18.
The report recommends that manufacturers be prohibited from making any health claims related to ENDS, specifically identifying claims that e-cigarettes are smoking cessation products. The report notes that there is anecdotal evidence to suggest e-cigarettes have been effective in helping people quit smoking but "their efficacy has not been systematically evaluated yet." WHO recommends that approved and proven cessation products should be tried first, with e-cigarettes being a last resort. Recent guidelines from the American Heart Association echoed that sentiment.
The WHO guidance is in line with recent recommendations made to the Food and Drug Administration from various medical societies in advocating for strict oversight in marketing to ensure that children are not targeted. The FDA is considering broadening its tobacco oversight to include e-cigarettes.
The use of electronic cigarettes, like that of their tobacco-containing cousins, should be banned in public indoor spaces, the World Health Organization recommends.
Users of electronic nicotine delivery systems devices (ENDS), such as e-cigarettes, should "be legally requested not to use ENDS indoors, especially where smoking is banned, until exhaled vapor is proved to be not harmful to bystanders and reasonable evidence exists that smoke-free policy enforcement is not undermined," according to a WHO report published Aug. 26.
The report is intended to provide a framework for governments to follow when developing regulations around e-cigarettes. It is on the agenda for the upcoming 6th Conference of the Parties to the WHO Framework Convention on Tobacco Control in Moscow Oct. 13-18.
The report recommends that manufacturers be prohibited from making any health claims related to ENDS, specifically identifying claims that e-cigarettes are smoking cessation products. The report notes that there is anecdotal evidence to suggest e-cigarettes have been effective in helping people quit smoking but "their efficacy has not been systematically evaluated yet." WHO recommends that approved and proven cessation products should be tried first, with e-cigarettes being a last resort. Recent guidelines from the American Heart Association echoed that sentiment.
The WHO guidance is in line with recent recommendations made to the Food and Drug Administration from various medical societies in advocating for strict oversight in marketing to ensure that children are not targeted. The FDA is considering broadening its tobacco oversight to include e-cigarettes.
The use of electronic cigarettes, like that of their tobacco-containing cousins, should be banned in public indoor spaces, the World Health Organization recommends.
Users of electronic nicotine delivery systems devices (ENDS), such as e-cigarettes, should "be legally requested not to use ENDS indoors, especially where smoking is banned, until exhaled vapor is proved to be not harmful to bystanders and reasonable evidence exists that smoke-free policy enforcement is not undermined," according to a WHO report published Aug. 26.
The report is intended to provide a framework for governments to follow when developing regulations around e-cigarettes. It is on the agenda for the upcoming 6th Conference of the Parties to the WHO Framework Convention on Tobacco Control in Moscow Oct. 13-18.
The report recommends that manufacturers be prohibited from making any health claims related to ENDS, specifically identifying claims that e-cigarettes are smoking cessation products. The report notes that there is anecdotal evidence to suggest e-cigarettes have been effective in helping people quit smoking but "their efficacy has not been systematically evaluated yet." WHO recommends that approved and proven cessation products should be tried first, with e-cigarettes being a last resort. Recent guidelines from the American Heart Association echoed that sentiment.
The WHO guidance is in line with recent recommendations made to the Food and Drug Administration from various medical societies in advocating for strict oversight in marketing to ensure that children are not targeted. The FDA is considering broadening its tobacco oversight to include e-cigarettes.
Pediatricians take aim at school start times
Middle schools and high schools should start no earlier than 8:30 a.m. because insufficient sleep "represents one of the most common, important, and potentially remediable health risks in children, particularly in the adolescent population for whom chronic loss has increasingly become the norm," according to a policy statement from the American Academy of Pediatrics.
The academy strongly supports the efforts of school districts to optimize students’ sleep to improve physical and mental health, safety, academic performance, and quality of life, according to the statement published Aug. 25 in Pediatrics (2014 Aug. 26 [doi:10.1542/peds.2014-1697]).
The AAP also advocates that:
• Pediatricians educate adolescents and parents regarding the optimal sleep amount teenagers need to match physiologic sleep needs (8.5-9.5 hours).
• Health care professionals, especially those working in school-based clinics or those advising schools, be aware of adolescent sleep needs and educate parents, teenagers, educators, coaches, and others on the biologic and environmental factors that contribute to sleep deprivation in youths.
• Educational interventions for parents, adolescents, and the public on the risks of chronic sleep loss in adolescents be developed and disseminated.
• Pediatricians provide scientific information, evidence-based rationales, guidance, and support to educate school administrators, parent-teacher associations, and school boards about the benefits of later school start times as a potentially cost-effective countermeasure to adolescent sleep deprivation.
In a companion report, Dr. Judith Owens noted that "short sleep durations, coupled with evidence of daytime sleepiness (for example, increased self-reported sleepiness ratings, daytime napping, weekend oversleeping, and need for assistance in waking), as well as increased use of fatigue countermeasures (for example, excessive caffeine consumption), all indicate that adolescents are sleeping fewer hours than they need to. The clear consistent message is that middle and high school students are not getting enough sleep" (2014 Aug. 25 [doi:10.1542/peds.2014-1696]).
Dr. Owens of Children’s National Health System of Washington, D.C., is a member of the AAP Adolescent Sleep Working Group and Committee on Adolescence.
Factors that contribute to sleep deprivation in adolescents include smartphones/tablets/computers, early school start times, excessive caffeine intake, mental health issues such as anxiety and stress, chronic respiratory issues, and pain, as well as obesity-related sleep apnea. Sleep loss has been associated with depression, mood disturbance, and suicidal thoughts, as well as an increased risk for obesity, according to the report.
"Pediatricians have the opportunity to make significant inroads into addressing the health risk that sleep loss presents through screening and health education efforts," Dr. Owens said. "Many of the factors that have been shown to contribute significantly to the current ‘epidemic’ of insufficient sleep in teenagers ... are potentially modifiable and, as such, are important intervention points in anticipatory guidance in the clinical setting."
Middle schools and high schools should start no earlier than 8:30 a.m. because insufficient sleep "represents one of the most common, important, and potentially remediable health risks in children, particularly in the adolescent population for whom chronic loss has increasingly become the norm," according to a policy statement from the American Academy of Pediatrics.
The academy strongly supports the efforts of school districts to optimize students’ sleep to improve physical and mental health, safety, academic performance, and quality of life, according to the statement published Aug. 25 in Pediatrics (2014 Aug. 26 [doi:10.1542/peds.2014-1697]).
The AAP also advocates that:
• Pediatricians educate adolescents and parents regarding the optimal sleep amount teenagers need to match physiologic sleep needs (8.5-9.5 hours).
• Health care professionals, especially those working in school-based clinics or those advising schools, be aware of adolescent sleep needs and educate parents, teenagers, educators, coaches, and others on the biologic and environmental factors that contribute to sleep deprivation in youths.
• Educational interventions for parents, adolescents, and the public on the risks of chronic sleep loss in adolescents be developed and disseminated.
• Pediatricians provide scientific information, evidence-based rationales, guidance, and support to educate school administrators, parent-teacher associations, and school boards about the benefits of later school start times as a potentially cost-effective countermeasure to adolescent sleep deprivation.
In a companion report, Dr. Judith Owens noted that "short sleep durations, coupled with evidence of daytime sleepiness (for example, increased self-reported sleepiness ratings, daytime napping, weekend oversleeping, and need for assistance in waking), as well as increased use of fatigue countermeasures (for example, excessive caffeine consumption), all indicate that adolescents are sleeping fewer hours than they need to. The clear consistent message is that middle and high school students are not getting enough sleep" (2014 Aug. 25 [doi:10.1542/peds.2014-1696]).
Dr. Owens of Children’s National Health System of Washington, D.C., is a member of the AAP Adolescent Sleep Working Group and Committee on Adolescence.
Factors that contribute to sleep deprivation in adolescents include smartphones/tablets/computers, early school start times, excessive caffeine intake, mental health issues such as anxiety and stress, chronic respiratory issues, and pain, as well as obesity-related sleep apnea. Sleep loss has been associated with depression, mood disturbance, and suicidal thoughts, as well as an increased risk for obesity, according to the report.
"Pediatricians have the opportunity to make significant inroads into addressing the health risk that sleep loss presents through screening and health education efforts," Dr. Owens said. "Many of the factors that have been shown to contribute significantly to the current ‘epidemic’ of insufficient sleep in teenagers ... are potentially modifiable and, as such, are important intervention points in anticipatory guidance in the clinical setting."
Middle schools and high schools should start no earlier than 8:30 a.m. because insufficient sleep "represents one of the most common, important, and potentially remediable health risks in children, particularly in the adolescent population for whom chronic loss has increasingly become the norm," according to a policy statement from the American Academy of Pediatrics.
The academy strongly supports the efforts of school districts to optimize students’ sleep to improve physical and mental health, safety, academic performance, and quality of life, according to the statement published Aug. 25 in Pediatrics (2014 Aug. 26 [doi:10.1542/peds.2014-1697]).
The AAP also advocates that:
• Pediatricians educate adolescents and parents regarding the optimal sleep amount teenagers need to match physiologic sleep needs (8.5-9.5 hours).
• Health care professionals, especially those working in school-based clinics or those advising schools, be aware of adolescent sleep needs and educate parents, teenagers, educators, coaches, and others on the biologic and environmental factors that contribute to sleep deprivation in youths.
• Educational interventions for parents, adolescents, and the public on the risks of chronic sleep loss in adolescents be developed and disseminated.
• Pediatricians provide scientific information, evidence-based rationales, guidance, and support to educate school administrators, parent-teacher associations, and school boards about the benefits of later school start times as a potentially cost-effective countermeasure to adolescent sleep deprivation.
In a companion report, Dr. Judith Owens noted that "short sleep durations, coupled with evidence of daytime sleepiness (for example, increased self-reported sleepiness ratings, daytime napping, weekend oversleeping, and need for assistance in waking), as well as increased use of fatigue countermeasures (for example, excessive caffeine consumption), all indicate that adolescents are sleeping fewer hours than they need to. The clear consistent message is that middle and high school students are not getting enough sleep" (2014 Aug. 25 [doi:10.1542/peds.2014-1696]).
Dr. Owens of Children’s National Health System of Washington, D.C., is a member of the AAP Adolescent Sleep Working Group and Committee on Adolescence.
Factors that contribute to sleep deprivation in adolescents include smartphones/tablets/computers, early school start times, excessive caffeine intake, mental health issues such as anxiety and stress, chronic respiratory issues, and pain, as well as obesity-related sleep apnea. Sleep loss has been associated with depression, mood disturbance, and suicidal thoughts, as well as an increased risk for obesity, according to the report.
"Pediatricians have the opportunity to make significant inroads into addressing the health risk that sleep loss presents through screening and health education efforts," Dr. Owens said. "Many of the factors that have been shown to contribute significantly to the current ‘epidemic’ of insufficient sleep in teenagers ... are potentially modifiable and, as such, are important intervention points in anticipatory guidance in the clinical setting."
FROM PEDIATRICS
FDA weighs its oversight role for clinical decision support tools
GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.
"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.
In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.
The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."
The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.
To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.
Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."
Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.
The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.
Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.
GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.
"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.
In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.
The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."
The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.
To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.
Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."
Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.
The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.
Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.
GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.
"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.
In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.
The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."
The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.
To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.
Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."
Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.
The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.
Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.
Better access to primary care proposed to cut nonurgent ED visits
A weak tie to a regular physician was seen in Medicaid patients who were high users of emergency departments, according to a recent analysis by the Medicaid and CHIP Payment and Access Commission.
"Expanding the availability of primary care could lead to more efficient use of the ED," a new report by MACPAC states. "However, ED use is likely to remain relatively high in Medicaid until new delivery models are in place to address the needs of frequent users."
The report, released July 31, estimates that nonurgent care accounts for 10% of all Medicaid-covered ED visits for nonelderly patients, a rate that is comparable with the one seen among privately insured patients.
Nearly all Medicaid enrollees report having a usual place of care other than the ED. Approximately one-third of adult and 13% of child enrollees have reported barriers to finding a doctor or delays in getting needed care, MACPAC’s research found. "Medicaid enrollees who report more primary care barriers are more likely to report ED use."
The analysis suggests that frequent ED use could be avoided with better access to primary care. "Some frequent ED users appear to receive inadequate primary or specialty care (while others use those services frequently). Among Medicaid enrollees with 10 or more ED visits in 1 year (who accounted for 12% of all ED visits), about half had weak ties to a regular physician."
Another factor is primary care physicians referring their patients to emergency departments because of the ability to rapidly utilize diagnostics. There has been "a sharp decline in direct admissions to the hospital by office-based physicians and an even sharper increase in the number of submissions through the ED: now, almost one-half of all nonelective admissions go through the ED," the report states
States have pursued a variety of paths to reduce ED visits, including diverting patients with complaints deemed to be nonemergencies to lower-cost settings, charging copayments for so-called nonemergency ED use, and focusing those considered "super utilizers" to other settings. The results of those initiatives have been mixed.
"Given Medicaid’s historically low reimbursement rates, the shortage of primary care physicians accepting these patients isn't surprising," Dr. Alex Rosenau, president of the American College of Emergency Physicians, said in a statement, adding that "efforts to deny payment for Medicaid visits to emergency departments are dangerous and wrong."
A weak tie to a regular physician was seen in Medicaid patients who were high users of emergency departments, according to a recent analysis by the Medicaid and CHIP Payment and Access Commission.
"Expanding the availability of primary care could lead to more efficient use of the ED," a new report by MACPAC states. "However, ED use is likely to remain relatively high in Medicaid until new delivery models are in place to address the needs of frequent users."
The report, released July 31, estimates that nonurgent care accounts for 10% of all Medicaid-covered ED visits for nonelderly patients, a rate that is comparable with the one seen among privately insured patients.
Nearly all Medicaid enrollees report having a usual place of care other than the ED. Approximately one-third of adult and 13% of child enrollees have reported barriers to finding a doctor or delays in getting needed care, MACPAC’s research found. "Medicaid enrollees who report more primary care barriers are more likely to report ED use."
The analysis suggests that frequent ED use could be avoided with better access to primary care. "Some frequent ED users appear to receive inadequate primary or specialty care (while others use those services frequently). Among Medicaid enrollees with 10 or more ED visits in 1 year (who accounted for 12% of all ED visits), about half had weak ties to a regular physician."
Another factor is primary care physicians referring their patients to emergency departments because of the ability to rapidly utilize diagnostics. There has been "a sharp decline in direct admissions to the hospital by office-based physicians and an even sharper increase in the number of submissions through the ED: now, almost one-half of all nonelective admissions go through the ED," the report states
States have pursued a variety of paths to reduce ED visits, including diverting patients with complaints deemed to be nonemergencies to lower-cost settings, charging copayments for so-called nonemergency ED use, and focusing those considered "super utilizers" to other settings. The results of those initiatives have been mixed.
"Given Medicaid’s historically low reimbursement rates, the shortage of primary care physicians accepting these patients isn't surprising," Dr. Alex Rosenau, president of the American College of Emergency Physicians, said in a statement, adding that "efforts to deny payment for Medicaid visits to emergency departments are dangerous and wrong."
A weak tie to a regular physician was seen in Medicaid patients who were high users of emergency departments, according to a recent analysis by the Medicaid and CHIP Payment and Access Commission.
"Expanding the availability of primary care could lead to more efficient use of the ED," a new report by MACPAC states. "However, ED use is likely to remain relatively high in Medicaid until new delivery models are in place to address the needs of frequent users."
The report, released July 31, estimates that nonurgent care accounts for 10% of all Medicaid-covered ED visits for nonelderly patients, a rate that is comparable with the one seen among privately insured patients.
Nearly all Medicaid enrollees report having a usual place of care other than the ED. Approximately one-third of adult and 13% of child enrollees have reported barriers to finding a doctor or delays in getting needed care, MACPAC’s research found. "Medicaid enrollees who report more primary care barriers are more likely to report ED use."
The analysis suggests that frequent ED use could be avoided with better access to primary care. "Some frequent ED users appear to receive inadequate primary or specialty care (while others use those services frequently). Among Medicaid enrollees with 10 or more ED visits in 1 year (who accounted for 12% of all ED visits), about half had weak ties to a regular physician."
Another factor is primary care physicians referring their patients to emergency departments because of the ability to rapidly utilize diagnostics. There has been "a sharp decline in direct admissions to the hospital by office-based physicians and an even sharper increase in the number of submissions through the ED: now, almost one-half of all nonelective admissions go through the ED," the report states
States have pursued a variety of paths to reduce ED visits, including diverting patients with complaints deemed to be nonemergencies to lower-cost settings, charging copayments for so-called nonemergency ED use, and focusing those considered "super utilizers" to other settings. The results of those initiatives have been mixed.
"Given Medicaid’s historically low reimbursement rates, the shortage of primary care physicians accepting these patients isn't surprising," Dr. Alex Rosenau, president of the American College of Emergency Physicians, said in a statement, adding that "efforts to deny payment for Medicaid visits to emergency departments are dangerous and wrong."
Pediatricians and colleagues call for childproof caps on e-cig refills
In an effort to protect children from unintentional exposure to liquid nicotine, a number of medical societies are supporting legislation to mandate childproof caps for liquid nicotine containers.
In an Aug. 11 letter to Sen. Bill Nelson (D-Fla.), the American Academy of Pediatricians, American College of Physicians, American College of Cardiology, American Academy of Otolaryngology-Head and Neck Surgery, and 26 other organizations highlighted the issue in support of the Child Nicotine Poisoning Prevention Act of 2014, which would require liquid nicotine containers to have childproof caps.
The letter highlights the danger liquid nicotine poses to children, noting that a small 15 mL bottle contains more than 500 mg of nicotine, a concentration that would be enough to kill four toddlers.
In the letter, the AAP noted federal data on the increase in calls regarding liquid nicotine to poison control centers from 1 per month in September 2010 to 215 per month in February 2014 (MMWR 2014;63:291-2).
The AAP also noted that liquid nicotine for e-cigarettes is often packaged in brightly colored containers and has flavors, such as berry or gummy bear that could be tempting for children and lead to unintended exposure, and is highly toxic when absorbed through the skin or ingested.
"Alarmingly, these products are often sold in containers without any childproofing, and there are currently no federal requirements for childproof packaging for liquid nicotine despite the highly toxic nature of these products," the letter states, adding that the bill "preserves FDA’s authority to regulate the manufacture, marketing, sale, and distribution of tobacco products and the packages and containers in which they are sold."
The American Association for Cancer Research and the American Society of Clinical Oncology recently called on the FDA to go further with its proposed rule for broadening its tobacco oversight regulations and called for a requirement that e-cigarette refill containers be childproof.
When do you think physicians should ask adolescents about their smoking habits? Take our Quick Poll on the Pediatric News homepage.
In an effort to protect children from unintentional exposure to liquid nicotine, a number of medical societies are supporting legislation to mandate childproof caps for liquid nicotine containers.
In an Aug. 11 letter to Sen. Bill Nelson (D-Fla.), the American Academy of Pediatricians, American College of Physicians, American College of Cardiology, American Academy of Otolaryngology-Head and Neck Surgery, and 26 other organizations highlighted the issue in support of the Child Nicotine Poisoning Prevention Act of 2014, which would require liquid nicotine containers to have childproof caps.
The letter highlights the danger liquid nicotine poses to children, noting that a small 15 mL bottle contains more than 500 mg of nicotine, a concentration that would be enough to kill four toddlers.
In the letter, the AAP noted federal data on the increase in calls regarding liquid nicotine to poison control centers from 1 per month in September 2010 to 215 per month in February 2014 (MMWR 2014;63:291-2).
The AAP also noted that liquid nicotine for e-cigarettes is often packaged in brightly colored containers and has flavors, such as berry or gummy bear that could be tempting for children and lead to unintended exposure, and is highly toxic when absorbed through the skin or ingested.
"Alarmingly, these products are often sold in containers without any childproofing, and there are currently no federal requirements for childproof packaging for liquid nicotine despite the highly toxic nature of these products," the letter states, adding that the bill "preserves FDA’s authority to regulate the manufacture, marketing, sale, and distribution of tobacco products and the packages and containers in which they are sold."
The American Association for Cancer Research and the American Society of Clinical Oncology recently called on the FDA to go further with its proposed rule for broadening its tobacco oversight regulations and called for a requirement that e-cigarette refill containers be childproof.
When do you think physicians should ask adolescents about their smoking habits? Take our Quick Poll on the Pediatric News homepage.
In an effort to protect children from unintentional exposure to liquid nicotine, a number of medical societies are supporting legislation to mandate childproof caps for liquid nicotine containers.
In an Aug. 11 letter to Sen. Bill Nelson (D-Fla.), the American Academy of Pediatricians, American College of Physicians, American College of Cardiology, American Academy of Otolaryngology-Head and Neck Surgery, and 26 other organizations highlighted the issue in support of the Child Nicotine Poisoning Prevention Act of 2014, which would require liquid nicotine containers to have childproof caps.
The letter highlights the danger liquid nicotine poses to children, noting that a small 15 mL bottle contains more than 500 mg of nicotine, a concentration that would be enough to kill four toddlers.
In the letter, the AAP noted federal data on the increase in calls regarding liquid nicotine to poison control centers from 1 per month in September 2010 to 215 per month in February 2014 (MMWR 2014;63:291-2).
The AAP also noted that liquid nicotine for e-cigarettes is often packaged in brightly colored containers and has flavors, such as berry or gummy bear that could be tempting for children and lead to unintended exposure, and is highly toxic when absorbed through the skin or ingested.
"Alarmingly, these products are often sold in containers without any childproofing, and there are currently no federal requirements for childproof packaging for liquid nicotine despite the highly toxic nature of these products," the letter states, adding that the bill "preserves FDA’s authority to regulate the manufacture, marketing, sale, and distribution of tobacco products and the packages and containers in which they are sold."
The American Association for Cancer Research and the American Society of Clinical Oncology recently called on the FDA to go further with its proposed rule for broadening its tobacco oversight regulations and called for a requirement that e-cigarette refill containers be childproof.
When do you think physicians should ask adolescents about their smoking habits? Take our Quick Poll on the Pediatric News homepage.
Setting benchmarks for hospitalized children with asthma, bronchiolitis, and pneumonia
With no currently accepted benchmarks for what constitutes best in class performance for treating children with asthma, bronchiolitis, and pneumonia, researchers recently set out to determine achievable benchmarks of care for the clinical quality indicators that hospitals can target to measure the care they are delivering.
"Even for the most common pediatric conditions, in which there are clear evidence-based guidelines for care, there continues to be significant variability in how well hospitals follow these guidelines," Dr. Kavita Parikh of the Children’s National Medical Center and George Washington School of Medicine in Washington, and her associates, reported in an article scheduled to appear in the September issue of Pediatrics (2014;134:555-62). "We have demonstrated that administrative data can be used to calculate ABCs [achievable benchmarks of care] for the top three admission diagnoses in pediatric hospital care. These ABCs represent measurable and attainable goals for standardization of care, and they can be the starting point for individual hospitals to evaluate their performance to a national standard."
Administrative data from encounters at 42 hospitals during 2012, including 22,186 asthma, 14,882 bronchiolitis, and 12,983 pneumonia encounters were reviewed. The following achievable benchmarks of care were determined:
• For asthma in children 2-18 years: chest radiograph utilization of 24.5%; antibiotic administration, 6.6%; and ipratropium bromide use greater than 2 days, 0%;
• For bronchiolitis in children 2 months-2 years: chest radiograph utilization of 32.4%; viral testing, 0.6%; antibiotic administration, 18.5%; bronchodilator use greater than 2 days of 0%; and steroid use, 6.4%.
• For pneumonia in children 2 months-18 years: complete blood cell count utilization, 28.8%; viral testing, 1.5%; initial narrow-spectrum antibiotic use, 60.7%; erythrocyte sedimentation rate, 3.5%; and C-reactive protein, 0.1%.
The authors said the study had several limitations. The data was based on outcomes at tertiary care hospitals, so it may not be generalizable to the non–tertiary care hospital setting. The authors also were unable to determine if the utilization occurred in the emergency room or in the inpatient setting.
The authors had no financial disclosures.
With no currently accepted benchmarks for what constitutes best in class performance for treating children with asthma, bronchiolitis, and pneumonia, researchers recently set out to determine achievable benchmarks of care for the clinical quality indicators that hospitals can target to measure the care they are delivering.
"Even for the most common pediatric conditions, in which there are clear evidence-based guidelines for care, there continues to be significant variability in how well hospitals follow these guidelines," Dr. Kavita Parikh of the Children’s National Medical Center and George Washington School of Medicine in Washington, and her associates, reported in an article scheduled to appear in the September issue of Pediatrics (2014;134:555-62). "We have demonstrated that administrative data can be used to calculate ABCs [achievable benchmarks of care] for the top three admission diagnoses in pediatric hospital care. These ABCs represent measurable and attainable goals for standardization of care, and they can be the starting point for individual hospitals to evaluate their performance to a national standard."
Administrative data from encounters at 42 hospitals during 2012, including 22,186 asthma, 14,882 bronchiolitis, and 12,983 pneumonia encounters were reviewed. The following achievable benchmarks of care were determined:
• For asthma in children 2-18 years: chest radiograph utilization of 24.5%; antibiotic administration, 6.6%; and ipratropium bromide use greater than 2 days, 0%;
• For bronchiolitis in children 2 months-2 years: chest radiograph utilization of 32.4%; viral testing, 0.6%; antibiotic administration, 18.5%; bronchodilator use greater than 2 days of 0%; and steroid use, 6.4%.
• For pneumonia in children 2 months-18 years: complete blood cell count utilization, 28.8%; viral testing, 1.5%; initial narrow-spectrum antibiotic use, 60.7%; erythrocyte sedimentation rate, 3.5%; and C-reactive protein, 0.1%.
The authors said the study had several limitations. The data was based on outcomes at tertiary care hospitals, so it may not be generalizable to the non–tertiary care hospital setting. The authors also were unable to determine if the utilization occurred in the emergency room or in the inpatient setting.
The authors had no financial disclosures.
With no currently accepted benchmarks for what constitutes best in class performance for treating children with asthma, bronchiolitis, and pneumonia, researchers recently set out to determine achievable benchmarks of care for the clinical quality indicators that hospitals can target to measure the care they are delivering.
"Even for the most common pediatric conditions, in which there are clear evidence-based guidelines for care, there continues to be significant variability in how well hospitals follow these guidelines," Dr. Kavita Parikh of the Children’s National Medical Center and George Washington School of Medicine in Washington, and her associates, reported in an article scheduled to appear in the September issue of Pediatrics (2014;134:555-62). "We have demonstrated that administrative data can be used to calculate ABCs [achievable benchmarks of care] for the top three admission diagnoses in pediatric hospital care. These ABCs represent measurable and attainable goals for standardization of care, and they can be the starting point for individual hospitals to evaluate their performance to a national standard."
Administrative data from encounters at 42 hospitals during 2012, including 22,186 asthma, 14,882 bronchiolitis, and 12,983 pneumonia encounters were reviewed. The following achievable benchmarks of care were determined:
• For asthma in children 2-18 years: chest radiograph utilization of 24.5%; antibiotic administration, 6.6%; and ipratropium bromide use greater than 2 days, 0%;
• For bronchiolitis in children 2 months-2 years: chest radiograph utilization of 32.4%; viral testing, 0.6%; antibiotic administration, 18.5%; bronchodilator use greater than 2 days of 0%; and steroid use, 6.4%.
• For pneumonia in children 2 months-18 years: complete blood cell count utilization, 28.8%; viral testing, 1.5%; initial narrow-spectrum antibiotic use, 60.7%; erythrocyte sedimentation rate, 3.5%; and C-reactive protein, 0.1%.
The authors said the study had several limitations. The data was based on outcomes at tertiary care hospitals, so it may not be generalizable to the non–tertiary care hospital setting. The authors also were unable to determine if the utilization occurred in the emergency room or in the inpatient setting.
The authors had no financial disclosures.
FROM PEDIATRICS
Key clinical finding: Benchmarks of care for hospitalized children with asthma, bronchiolitis, and pneumonia may reduce the variability in how hospitals follow guidelines.
Major finding: An achievable benchmark of care for utilization of antibiotics of 18.5% for treatment of pediatric bronchiolitis is among a number of ABCs determined by report authors.
Data source: A cross-sectional trial using administrative data from the Pediatric Health Information System database used to evaluate hospital-level resource utilization for children requiring hospital care for each of the three diagnoses during calendar year 2012.
Disclosures: The authors had no financial disclosures.
ASCO and AACR call for stronger e-cigarette regulation
A Food and Drug Administration proposal to regulate e-cigarettes does not go far enough, the American Society of Clinical Oncology and the American Association for Cancer Research say.
The two societies offered their general support for the agency’s proposed rule that would broaden its regulatory oversight over tobacco products in general, but offered suggestions to take the proposal even further.
In the area of e-cigarettes, the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR) called for the agency to regulate both electronic nicotine delivery systems (ENDS) as well as the component parts such as the liquids sold separately as refills for e-cigarettes. Additionally, the FDA "should develop a product standard that would require all e-liquid refill bottles to be childproof, including childproof caps for eye-dropper refill bottles," the societies said in comments they submitted together to the FDA on the proposed changes. "Future research may point to the need for additional product changes for ENDS, including standards regulating design, constituents, nicotine levels, or other chemicals including ENDS vapor, and we encourage [the] FDA to require such changes as appropriate to protect the public health."
The FDA issued its proposed rule in April.
In a statement, Dr. Roy Herbst, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center of New Haven, Conn., noted that there is "insufficient data on the long-term health consequences of e-cigarettes, their value as tobacco-cessation aids, or their effects on the use of conventional cigarettes. Any benefits of e-cigarettes are most likely to be realized in a regulated environment in which appropriate safeguards can be implemented."
Other areas highlighted by the groups that reach further than the FDA’s current proposal include product labeling, marketing, and product flavoring.
For example, the groups call for the FDA to strengthen its proposal in the sales, marketing, and advertising area by expressly prohibiting "self-service displays of tobacco products in retail establishments; the provision of gifts and other giveaways with purchase of tobacco products; the sale and distribution of items such as hats or t-shirts with tobacco product brand logos; brand-name sponsorship of athletic, musical, or other social or cultural events, or any team entry into those events; and youth-oriented advertising of tobacco products, including the use of cartoon characters in tobacco product advertising, promotion, packaging, or labeling." These would apply to all tobacco products, including e-cigarettes and cigars.
These marketing restrictions would enhance the FDA’s proposal to require manufacturers to submit new product marketing materials for agency review, AACR and ASCO say. The groups also call for stronger age-verification rules related to the Internet purchase of tobacco products.
A Food and Drug Administration proposal to regulate e-cigarettes does not go far enough, the American Society of Clinical Oncology and the American Association for Cancer Research say.
The two societies offered their general support for the agency’s proposed rule that would broaden its regulatory oversight over tobacco products in general, but offered suggestions to take the proposal even further.
In the area of e-cigarettes, the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR) called for the agency to regulate both electronic nicotine delivery systems (ENDS) as well as the component parts such as the liquids sold separately as refills for e-cigarettes. Additionally, the FDA "should develop a product standard that would require all e-liquid refill bottles to be childproof, including childproof caps for eye-dropper refill bottles," the societies said in comments they submitted together to the FDA on the proposed changes. "Future research may point to the need for additional product changes for ENDS, including standards regulating design, constituents, nicotine levels, or other chemicals including ENDS vapor, and we encourage [the] FDA to require such changes as appropriate to protect the public health."
The FDA issued its proposed rule in April.
In a statement, Dr. Roy Herbst, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center of New Haven, Conn., noted that there is "insufficient data on the long-term health consequences of e-cigarettes, their value as tobacco-cessation aids, or their effects on the use of conventional cigarettes. Any benefits of e-cigarettes are most likely to be realized in a regulated environment in which appropriate safeguards can be implemented."
Other areas highlighted by the groups that reach further than the FDA’s current proposal include product labeling, marketing, and product flavoring.
For example, the groups call for the FDA to strengthen its proposal in the sales, marketing, and advertising area by expressly prohibiting "self-service displays of tobacco products in retail establishments; the provision of gifts and other giveaways with purchase of tobacco products; the sale and distribution of items such as hats or t-shirts with tobacco product brand logos; brand-name sponsorship of athletic, musical, or other social or cultural events, or any team entry into those events; and youth-oriented advertising of tobacco products, including the use of cartoon characters in tobacco product advertising, promotion, packaging, or labeling." These would apply to all tobacco products, including e-cigarettes and cigars.
These marketing restrictions would enhance the FDA’s proposal to require manufacturers to submit new product marketing materials for agency review, AACR and ASCO say. The groups also call for stronger age-verification rules related to the Internet purchase of tobacco products.
A Food and Drug Administration proposal to regulate e-cigarettes does not go far enough, the American Society of Clinical Oncology and the American Association for Cancer Research say.
The two societies offered their general support for the agency’s proposed rule that would broaden its regulatory oversight over tobacco products in general, but offered suggestions to take the proposal even further.
In the area of e-cigarettes, the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR) called for the agency to regulate both electronic nicotine delivery systems (ENDS) as well as the component parts such as the liquids sold separately as refills for e-cigarettes. Additionally, the FDA "should develop a product standard that would require all e-liquid refill bottles to be childproof, including childproof caps for eye-dropper refill bottles," the societies said in comments they submitted together to the FDA on the proposed changes. "Future research may point to the need for additional product changes for ENDS, including standards regulating design, constituents, nicotine levels, or other chemicals including ENDS vapor, and we encourage [the] FDA to require such changes as appropriate to protect the public health."
The FDA issued its proposed rule in April.
In a statement, Dr. Roy Herbst, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center of New Haven, Conn., noted that there is "insufficient data on the long-term health consequences of e-cigarettes, their value as tobacco-cessation aids, or their effects on the use of conventional cigarettes. Any benefits of e-cigarettes are most likely to be realized in a regulated environment in which appropriate safeguards can be implemented."
Other areas highlighted by the groups that reach further than the FDA’s current proposal include product labeling, marketing, and product flavoring.
For example, the groups call for the FDA to strengthen its proposal in the sales, marketing, and advertising area by expressly prohibiting "self-service displays of tobacco products in retail establishments; the provision of gifts and other giveaways with purchase of tobacco products; the sale and distribution of items such as hats or t-shirts with tobacco product brand logos; brand-name sponsorship of athletic, musical, or other social or cultural events, or any team entry into those events; and youth-oriented advertising of tobacco products, including the use of cartoon characters in tobacco product advertising, promotion, packaging, or labeling." These would apply to all tobacco products, including e-cigarettes and cigars.
These marketing restrictions would enhance the FDA’s proposal to require manufacturers to submit new product marketing materials for agency review, AACR and ASCO say. The groups also call for stronger age-verification rules related to the Internet purchase of tobacco products.
FDA looks to make companion diagnostics, lab tests more reliable
Last month, the Food and Drug Administration announced the latest steps it is taking to advance the use of personalized medicine.
First, the agency finalized guidance on the development of companion diagnostics. Second, it signaled its intent to begin oversight of certain laboratory developed tests (LDTs), tests that are designed, manufactured, and used within a single laboratory.
The guidance, initially issued as a draft in July 2011, offers the agency’s thinking on its expectations on the development of companion diagnostics. No substantive changes were made to the final guidance document from its draft version, agency officials said.
"When drug companies develop therapies that will only work on specific subpopulations, it’s important those therapies are approved with a diagnostic test that the FDA knows is accurate and reliable and patients and their physicians can count on," FDA Commissioner Dr. Margaret Hamburg said during a press teleconference.
The agency also revealed its initial thoughts on how it will regulate LDTs in a letter to Congress. The FDA is required to let Congress know 60 days prior to the issuance of draft and final guidance. The forthcoming draft represents a change in how the agency is approaching LDTs.
"The FDA has historically exercised enforcement discretion over LDTs, meaning the agency generally did not enforce applicable regulatory requirements on the tests because they were generally considered lower risk and used on a limited basis within a given institution," Dr. Hamburg said. "Today, they may be marketed and used more broadly and compete with FDA-approved tests without clinical studies to support their use. The deeper concern is about physicians and patients making critical health decisions based on diagnostic tests that have generally not been reviewed by the FDA. Without premarket review by the agency, patients, their health care providers, or the FDA itself cannot be assured those tests are accurate and reliable."
Dr. Hamburg said the agency plans to enforce premarket review requirements for higher-risk LDTs, "including those used to determine medical treatment and that have the same intended use of FDA-approved and FDA-cleared companion diagnostics currently on the market."
The agency’s actions received praise from cancer researchers.
"The recent announcements by the FDA are aimed at providing patients and their physicians with an important level of confidence and certainty with regard to the highly complex molecular and genetic information that these diagnostic tests are determining," American Association for Cancer Research President Dr. Carlos L. Arteaga said in a statement. "As an organization that represents the entire continuum of research, from the laboratory to the clinic, including the clinical researchers and physician-scientists engaged in cancer patient care, the AACR looks forward to continuing to engage with the FDA to ensure that the molecular and genetic diagnostic tests that are being utilized by physicians and patients are based on solidly supported scientific evidence."
Many in the health care community, particularly those in the oncology community, are looking at how best to use personalized medicine as a means of achieving better treatment outcomes and controlling costs of health care.
Last month, the Food and Drug Administration announced the latest steps it is taking to advance the use of personalized medicine.
First, the agency finalized guidance on the development of companion diagnostics. Second, it signaled its intent to begin oversight of certain laboratory developed tests (LDTs), tests that are designed, manufactured, and used within a single laboratory.
The guidance, initially issued as a draft in July 2011, offers the agency’s thinking on its expectations on the development of companion diagnostics. No substantive changes were made to the final guidance document from its draft version, agency officials said.
"When drug companies develop therapies that will only work on specific subpopulations, it’s important those therapies are approved with a diagnostic test that the FDA knows is accurate and reliable and patients and their physicians can count on," FDA Commissioner Dr. Margaret Hamburg said during a press teleconference.
The agency also revealed its initial thoughts on how it will regulate LDTs in a letter to Congress. The FDA is required to let Congress know 60 days prior to the issuance of draft and final guidance. The forthcoming draft represents a change in how the agency is approaching LDTs.
"The FDA has historically exercised enforcement discretion over LDTs, meaning the agency generally did not enforce applicable regulatory requirements on the tests because they were generally considered lower risk and used on a limited basis within a given institution," Dr. Hamburg said. "Today, they may be marketed and used more broadly and compete with FDA-approved tests without clinical studies to support their use. The deeper concern is about physicians and patients making critical health decisions based on diagnostic tests that have generally not been reviewed by the FDA. Without premarket review by the agency, patients, their health care providers, or the FDA itself cannot be assured those tests are accurate and reliable."
Dr. Hamburg said the agency plans to enforce premarket review requirements for higher-risk LDTs, "including those used to determine medical treatment and that have the same intended use of FDA-approved and FDA-cleared companion diagnostics currently on the market."
The agency’s actions received praise from cancer researchers.
"The recent announcements by the FDA are aimed at providing patients and their physicians with an important level of confidence and certainty with regard to the highly complex molecular and genetic information that these diagnostic tests are determining," American Association for Cancer Research President Dr. Carlos L. Arteaga said in a statement. "As an organization that represents the entire continuum of research, from the laboratory to the clinic, including the clinical researchers and physician-scientists engaged in cancer patient care, the AACR looks forward to continuing to engage with the FDA to ensure that the molecular and genetic diagnostic tests that are being utilized by physicians and patients are based on solidly supported scientific evidence."
Many in the health care community, particularly those in the oncology community, are looking at how best to use personalized medicine as a means of achieving better treatment outcomes and controlling costs of health care.
Last month, the Food and Drug Administration announced the latest steps it is taking to advance the use of personalized medicine.
First, the agency finalized guidance on the development of companion diagnostics. Second, it signaled its intent to begin oversight of certain laboratory developed tests (LDTs), tests that are designed, manufactured, and used within a single laboratory.
The guidance, initially issued as a draft in July 2011, offers the agency’s thinking on its expectations on the development of companion diagnostics. No substantive changes were made to the final guidance document from its draft version, agency officials said.
"When drug companies develop therapies that will only work on specific subpopulations, it’s important those therapies are approved with a diagnostic test that the FDA knows is accurate and reliable and patients and their physicians can count on," FDA Commissioner Dr. Margaret Hamburg said during a press teleconference.
The agency also revealed its initial thoughts on how it will regulate LDTs in a letter to Congress. The FDA is required to let Congress know 60 days prior to the issuance of draft and final guidance. The forthcoming draft represents a change in how the agency is approaching LDTs.
"The FDA has historically exercised enforcement discretion over LDTs, meaning the agency generally did not enforce applicable regulatory requirements on the tests because they were generally considered lower risk and used on a limited basis within a given institution," Dr. Hamburg said. "Today, they may be marketed and used more broadly and compete with FDA-approved tests without clinical studies to support their use. The deeper concern is about physicians and patients making critical health decisions based on diagnostic tests that have generally not been reviewed by the FDA. Without premarket review by the agency, patients, their health care providers, or the FDA itself cannot be assured those tests are accurate and reliable."
Dr. Hamburg said the agency plans to enforce premarket review requirements for higher-risk LDTs, "including those used to determine medical treatment and that have the same intended use of FDA-approved and FDA-cleared companion diagnostics currently on the market."
The agency’s actions received praise from cancer researchers.
"The recent announcements by the FDA are aimed at providing patients and their physicians with an important level of confidence and certainty with regard to the highly complex molecular and genetic information that these diagnostic tests are determining," American Association for Cancer Research President Dr. Carlos L. Arteaga said in a statement. "As an organization that represents the entire continuum of research, from the laboratory to the clinic, including the clinical researchers and physician-scientists engaged in cancer patient care, the AACR looks forward to continuing to engage with the FDA to ensure that the molecular and genetic diagnostic tests that are being utilized by physicians and patients are based on solidly supported scientific evidence."
Many in the health care community, particularly those in the oncology community, are looking at how best to use personalized medicine as a means of achieving better treatment outcomes and controlling costs of health care.
Many surgical residents consider quitting during training
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
Program directors at residency programs "must take a purposeful, proactive approach from the beginning of surgery residency that shows residents how they can achieve a healthy balance of work and life, create practices over which they have control, and live happy, productive lives," Dr. Karen Deveney writes in a commentary published online July 30 in JAMA Surgery 2014 [doi:10.1001/jamasurg.2014964]).
Dr. Deveney also cautioned about current surgeons being openly critical of their chosen profession. "We have failed our younger generation if we whine and complain about our wretched lives rather than taking steps that are available to use to be proactive, take control of our own fates, and realize what a privileged position we are in as surgeons. Women residents are particularly vulnerable to worries that they may not be able to juggle competing demands of their families and their careers and need to be matched with female surgeons in practice who have managed successfully to find that balance."
Dr. Deveney works in the department of surgery at the Oregon Health and Science University in Portland.
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
A majority of general surgery residents seriously consider dropping out of their training, with female residents more likely to consider quitting, a new study in JAMA Surgery reveals.
According to a survey, 58.0% of the 288 respondents "seriously considered leaving training." The most frequent reasons cited for wanting to quit training were sleep deprivation on a specific rotation (50%), an undesirable future lifestyle (47%), and excessive work hours on a specific rotation (41.4%). Survey results were published online July 30 in JAMA Surgery (2014 [doi:10.1001/jamasurg.2014.935]).
Factors cited that ultimately keep general surgery residents from ending training are support from family or significant other (65%), support from other residents (63.5%), and perception of being better rested (58.9%).
"We believe that our survey findings highlight the fact that a desire to leave training may not be affected by job rigor alone but rather [by] program-specific or rotation-specific factors or dissatisfaction with a future career in general surgery," the report states. Dr. Edward Gifford of the department of surgery, University of California, Los Angeles, Medical Center, is the report’s lead author.
In addressing the factors that led to consideration for leaving training, the authors noted that "a potential remedy may be to identify those high work-hour rotations and modify them accordingly," though lifestyle concerns may be harder to address as practicing surgeons "continue to experience high levels of work-home conflicts and burnout."
For women specifically, another issue is "the paucity of female mentors in academic surgery," the report states. "Striving to increase the number of female faculty members within training programs and refining the mentor-mentee relationship with incoming residents may improve the outlook and productivity of future female surgeons."
Overall, while men’s thoughts of quitting decreased as their residency progressed, women’s considerations remained persistent. The report cites previous studies that reported that men and women view general surgery careers differently, including that it was not a welcoming career because of lifestyle challenges, particularly if the woman had children, limited flexible training, and lack of role models.
"These findings may explain why women in our survey continued to consider leaving residency throughout the duration of training and underscores the importance of supporting female residents through the difficult balance between motherhood and professional life," the report states.
The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
FROM JAMA Surgery
Major finding: More than half of survey respondents (58%) considered quitting their general surgery residency, an issue more persistent with female respondents.
Data source: Analysis of 288 responses to a survey of general surgery residents in 13 residency programs across different regions (West, Southwest, Midwest, and Northeast) and training centers (university programs, independent programs, or hybrid university-affiliated programs without an onsite university or medical school).
Disclosures: The study was approved by the human subjects committee of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles. The authors reported no conflicts of interest.
Admitting privilege requirement unconstitutional, appeals court rules
A law that requires abortion providers in Mississippi to have hospital admitting privileges was ruled unconstitutional by a panel of judges in the U.S. 5th Circuit Court of Appeals, effectively keeping open the state’s lone abortion clinic in Jackson.
The 2-1 ruling notes that the ultimate issue "is whether the State of Mississippi can impose a regulation that effectively will close its only abortion clinic. ... Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state’s obligation under the principle of federalism – applicable to all 50 states – to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens."
Jackson Women’s Health Organization, the state’s only licensed abortion clinic, challenged the April 2012 law that required all physicians who perform abortions at an abortion facility to be board-certified or board-eligible ob.gyns. with staff and admitting privileges at a local hospital. The law also required that a person trained in CPR must be present at the abortion clinic whenever it is open.
According to the ruling, one of the three doctors at the clinic had admitting privileges. The two others were unable to get privileges at any of the seven local hospitals. Cited reasons included "[t]he nature of your proposed medical practice is inconsistent with this Hospital’s policies and practices as concerns abortion and, in particular elective abortion," and "[t]he nature of your proposed medical practice would lead to both an internal and external disruption of the Hospital’s function and business within this community."
Although not specifically commenting on this case, the American College of Obstetricians and Gynecologists has in general advocated against the imposition of admitting privileges requirements on doctors working at abortion clinics.
"Admitting privileges legislation would impose stricter requirements on facilities where abortions are performed than on facilities that perform much riskier procedures, including those that use general anesthesia," Dr. Jeanne Conry, immediate past president of ACOG and assistant physician in chief at Kaiser Permanente in Rosedale, Calif., said during a telebriefing in May. "As an example, the mortality rate associated with a colonoscopy is more than 40 times greater that that of abortion, yet gastroenterologists face no restriction of their practice in the context of ‘safety.’ "
Senate Democrats are pushing a bill that would overturn most state restrictions on abortion services.
A law that requires abortion providers in Mississippi to have hospital admitting privileges was ruled unconstitutional by a panel of judges in the U.S. 5th Circuit Court of Appeals, effectively keeping open the state’s lone abortion clinic in Jackson.
The 2-1 ruling notes that the ultimate issue "is whether the State of Mississippi can impose a regulation that effectively will close its only abortion clinic. ... Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state’s obligation under the principle of federalism – applicable to all 50 states – to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens."
Jackson Women’s Health Organization, the state’s only licensed abortion clinic, challenged the April 2012 law that required all physicians who perform abortions at an abortion facility to be board-certified or board-eligible ob.gyns. with staff and admitting privileges at a local hospital. The law also required that a person trained in CPR must be present at the abortion clinic whenever it is open.
According to the ruling, one of the three doctors at the clinic had admitting privileges. The two others were unable to get privileges at any of the seven local hospitals. Cited reasons included "[t]he nature of your proposed medical practice is inconsistent with this Hospital’s policies and practices as concerns abortion and, in particular elective abortion," and "[t]he nature of your proposed medical practice would lead to both an internal and external disruption of the Hospital’s function and business within this community."
Although not specifically commenting on this case, the American College of Obstetricians and Gynecologists has in general advocated against the imposition of admitting privileges requirements on doctors working at abortion clinics.
"Admitting privileges legislation would impose stricter requirements on facilities where abortions are performed than on facilities that perform much riskier procedures, including those that use general anesthesia," Dr. Jeanne Conry, immediate past president of ACOG and assistant physician in chief at Kaiser Permanente in Rosedale, Calif., said during a telebriefing in May. "As an example, the mortality rate associated with a colonoscopy is more than 40 times greater that that of abortion, yet gastroenterologists face no restriction of their practice in the context of ‘safety.’ "
Senate Democrats are pushing a bill that would overturn most state restrictions on abortion services.
A law that requires abortion providers in Mississippi to have hospital admitting privileges was ruled unconstitutional by a panel of judges in the U.S. 5th Circuit Court of Appeals, effectively keeping open the state’s lone abortion clinic in Jackson.
The 2-1 ruling notes that the ultimate issue "is whether the State of Mississippi can impose a regulation that effectively will close its only abortion clinic. ... Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state’s obligation under the principle of federalism – applicable to all 50 states – to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens."
Jackson Women’s Health Organization, the state’s only licensed abortion clinic, challenged the April 2012 law that required all physicians who perform abortions at an abortion facility to be board-certified or board-eligible ob.gyns. with staff and admitting privileges at a local hospital. The law also required that a person trained in CPR must be present at the abortion clinic whenever it is open.
According to the ruling, one of the three doctors at the clinic had admitting privileges. The two others were unable to get privileges at any of the seven local hospitals. Cited reasons included "[t]he nature of your proposed medical practice is inconsistent with this Hospital’s policies and practices as concerns abortion and, in particular elective abortion," and "[t]he nature of your proposed medical practice would lead to both an internal and external disruption of the Hospital’s function and business within this community."
Although not specifically commenting on this case, the American College of Obstetricians and Gynecologists has in general advocated against the imposition of admitting privileges requirements on doctors working at abortion clinics.
"Admitting privileges legislation would impose stricter requirements on facilities where abortions are performed than on facilities that perform much riskier procedures, including those that use general anesthesia," Dr. Jeanne Conry, immediate past president of ACOG and assistant physician in chief at Kaiser Permanente in Rosedale, Calif., said during a telebriefing in May. "As an example, the mortality rate associated with a colonoscopy is more than 40 times greater that that of abortion, yet gastroenterologists face no restriction of their practice in the context of ‘safety.’ "
Senate Democrats are pushing a bill that would overturn most state restrictions on abortion services.
