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Courts temporarily block Title X changes
U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.
Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.
“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.
Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.
HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.
Washington state and the National Family Planning & Reproductive Health Association sued the U.S. Department of Health & Human Services in early March to block the agency from enforcing the modifications. A separate lawsuit was filed by the American Medical Association and the Planned Parenthood Federation of America to stop the funding changes, and 22 states issued a third legal challenge. The Title X changes impose a “government gag rule” on what information physicians can provide to their patients, according to the plaintiffs.
The American College of Physicians (ACP) and other groups, including the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have voiced their opposition to the Title X restrictions. In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.
Washington Attorney General Bob Ferguson said the nationwide ban ensures that clinics across the nation can remain open and continue to provide quality, unbiased health care to women
“Trump’s ‘gag rule’ would have jeopardized health care access to women across the country,” he said in a statement. “Title X clinics, such as Planned Parenthood, provide essential services – now they can keep serving women while we continue to fight to keep the federal government out of the exam room.”
AMA President Barbara L. McAneny, MD, praised Judge McShane’s order. “The new rule would have placed obstacles to health care for low-income patients,” Dr. McAneny said in a statement. “We are pleased the judge shared the AMA’s concern about the physician-patient relationship that the rule would have jeopardized.”
The Trump administration had not said at press time whether it would appeal the order.
Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support of the Title X funding restrictions.
“The rule advances President Trump’s promise to stop taxpayer funding of abortion businesses like Planned Parenthood,” SBA List President Marjorie Dannenfelser said in a statement. “The Protect Life Rule does not cut family planning funding by a single dime, and instead directs tax dollars to entities that provide health care to women but do not perform abortions.”
[email protected]
U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.
Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.
“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.
Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.
HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.
Washington state and the National Family Planning & Reproductive Health Association sued the U.S. Department of Health & Human Services in early March to block the agency from enforcing the modifications. A separate lawsuit was filed by the American Medical Association and the Planned Parenthood Federation of America to stop the funding changes, and 22 states issued a third legal challenge. The Title X changes impose a “government gag rule” on what information physicians can provide to their patients, according to the plaintiffs.
The American College of Physicians (ACP) and other groups, including the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have voiced their opposition to the Title X restrictions. In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.
Washington Attorney General Bob Ferguson said the nationwide ban ensures that clinics across the nation can remain open and continue to provide quality, unbiased health care to women
“Trump’s ‘gag rule’ would have jeopardized health care access to women across the country,” he said in a statement. “Title X clinics, such as Planned Parenthood, provide essential services – now they can keep serving women while we continue to fight to keep the federal government out of the exam room.”
AMA President Barbara L. McAneny, MD, praised Judge McShane’s order. “The new rule would have placed obstacles to health care for low-income patients,” Dr. McAneny said in a statement. “We are pleased the judge shared the AMA’s concern about the physician-patient relationship that the rule would have jeopardized.”
The Trump administration had not said at press time whether it would appeal the order.
Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support of the Title X funding restrictions.
“The rule advances President Trump’s promise to stop taxpayer funding of abortion businesses like Planned Parenthood,” SBA List President Marjorie Dannenfelser said in a statement. “The Protect Life Rule does not cut family planning funding by a single dime, and instead directs tax dollars to entities that provide health care to women but do not perform abortions.”
[email protected]
U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.
Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.
“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.
Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.
HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.
Washington state and the National Family Planning & Reproductive Health Association sued the U.S. Department of Health & Human Services in early March to block the agency from enforcing the modifications. A separate lawsuit was filed by the American Medical Association and the Planned Parenthood Federation of America to stop the funding changes, and 22 states issued a third legal challenge. The Title X changes impose a “government gag rule” on what information physicians can provide to their patients, according to the plaintiffs.
The American College of Physicians (ACP) and other groups, including the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have voiced their opposition to the Title X restrictions. In a joint court brief, the medical societies wrote that the Trump administration’s limitations to the Title X program will create cultural, geographic, and financial barriers to care; erode the physician-patient relationship; and cause extreme, immediate, and irreparable harm to millions of patients.
Washington Attorney General Bob Ferguson said the nationwide ban ensures that clinics across the nation can remain open and continue to provide quality, unbiased health care to women
“Trump’s ‘gag rule’ would have jeopardized health care access to women across the country,” he said in a statement. “Title X clinics, such as Planned Parenthood, provide essential services – now they can keep serving women while we continue to fight to keep the federal government out of the exam room.”
AMA President Barbara L. McAneny, MD, praised Judge McShane’s order. “The new rule would have placed obstacles to health care for low-income patients,” Dr. McAneny said in a statement. “We are pleased the judge shared the AMA’s concern about the physician-patient relationship that the rule would have jeopardized.”
The Trump administration had not said at press time whether it would appeal the order.
Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support of the Title X funding restrictions.
“The rule advances President Trump’s promise to stop taxpayer funding of abortion businesses like Planned Parenthood,” SBA List President Marjorie Dannenfelser said in a statement. “The Protect Life Rule does not cut family planning funding by a single dime, and instead directs tax dollars to entities that provide health care to women but do not perform abortions.”
[email protected]
Teen e-cigarette use: A public health crisis
After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2
E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6
One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.
E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.
Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10
Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.
Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.
Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.
The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at [email protected].
References
1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.
2. e-cigarettes.surgeongeneral.gov
3. N Engl J Med 2019;380:629-37.
4. Pediatrics. 2018 Dec; 142(6):e20180486.
5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.
6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.
7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).
8. N Engl J Med 2014;371:932-43.
9. N Engl J Med 2019;380:689-90.
10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.
11. Pediatrics. 2019 Feb;143(2). pii: e20183652.
After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2
E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6
One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.
E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.
Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10
Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.
Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.
Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.
The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at [email protected].
References
1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.
2. e-cigarettes.surgeongeneral.gov
3. N Engl J Med 2019;380:629-37.
4. Pediatrics. 2018 Dec; 142(6):e20180486.
5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.
6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.
7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).
8. N Engl J Med 2014;371:932-43.
9. N Engl J Med 2019;380:689-90.
10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.
11. Pediatrics. 2019 Feb;143(2). pii: e20183652.
After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2
E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6
One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.
E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.
Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10
Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.
Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.
Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.
The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at [email protected].
References
1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.
2. e-cigarettes.surgeongeneral.gov
3. N Engl J Med 2019;380:629-37.
4. Pediatrics. 2018 Dec; 142(6):e20180486.
5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.
6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.
7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).
8. N Engl J Med 2014;371:932-43.
9. N Engl J Med 2019;380:689-90.
10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.
11. Pediatrics. 2019 Feb;143(2). pii: e20183652.
Young lupus patients need more than medications
SAN FRANCISCO – – and therein lies the importance of introducing interventions beyond simply prescribing appropriate medications, Hermine I. Brunner, MD, asserted at an international congress on systemic lupus erythematosus.
Pilot studies conducted by her research group as well as others suggest that brief cognitive-behavioral interventions, web-based patient and caregiver education, and social media interactions significantly improve the fatigue and depression, poor quality of life, and lack of adherence to medication that are pervasive in young patients with SLE, according to Dr. Brunner, director of the division of rheumatology and professor of pediatrics at the University of Cincinnati and scientific director of the Pediatric Rheumatology Collaborative Study Group.
“Don’t misunderstand: I don’t think we can treat lupus simply with a psychological intervention at the bedside. However, I think doctors would be well advised to offer both psychological interventions and medication when they see young lupus patients, because without the psychological intervention the patients may not feel sufficiently at ease to take their medication. They will not get the benefit of the medications you’ve prescribed,” she said.
Patients with SLE take an average of eight medications daily. Their medication adherence rate is comparable to that of patients with diabetes or many other chronic diseases: that is to say, lousy. When investigators at the University of Texas MD Anderson Cancer Center, Houston, utilized an electronic monitoring system to chart adherence to prescribed oral medications in adults with SLE, they found that over the course of 2 years of follow-up only one-fourth of them had an adherence rate of 80% or better, which is the standard definition of adherence (Lupus. 2012 Oct;21[11]:1158-65).
Treatment adherence is particularly problematic in adolescents and young adults with SLE. They often have great difficulty in mastering the self-management skills required to stay on top of their disease when they have so much else going on during what is a vulnerable and challenging period of development, even for healthy youths.
The texting intervention
Dr. Brunner and her colleagues at Cincinnati Children’s Hospital Medical Center recognized the scope of the nonadherence problem early on. Years ago they started sending text messaging reminders of pending clinic visits to their patients who had a poor track record of showing up for appointments.
“We texted patients 2 weeks before their scheduled visit, 1 week before, and then again the day before the visit,” she explained.
This simple intervention resulted in a 47% reduction in missed appointments, compared with a control group. Also, text recipients were more likely to cancel appointments instead of simply not showing up, an important benefit from a practice management and scheduling standpoint (J Rheumatol. 2012 Jan;39[1]:174-9). Disappointingly, however, the text messaging intervention had no impact on adherence to prescribed use of hydroxychloroquine. This led the investigators to conduct a deeper dive into the roots of the nonadherence problem in childhood-onset lupus.
Disease control, quality of life
Dr. Brunner and her coworkers conducted an in-depth assessment of health-related quality of life in 50 patients with childhood-onset SLE over the course of 6 months. The results were surprising.
“When we looked at the correlation between disease control and quality of life, actually there was none,” according to the pediatric rheumatologist.
Instead, the investigators found that young patients with persistently low quality of life despite objectively measured good disease control scored high for fatigue and depressive symptoms (Lupus. 2018 Jan;27[1]:124-33). This led Dr. Brunner and her coinvestigators to consider developing a practical behavioral intervention to address these potentially modifiable predictors of impaired health-related quality of life in their patient population.
The need for novel approaches was highlighted in focus groups conducted by the investigators, in which patients and their primary caregivers emphasized that current therapeutic strategies don’t adequately address key problems of living with lupus, especially the prominent fatigue, pain, and depressed mood that hamper daily function and personal relationships. Patients said they don’t feel an immediate benefit from taking their medications, so why bother? And parents expressed frustration about how difficult it is to get their teenagers to understand the consequences of nonadherence when they’re at an age when they don’t yet even grasp the concept of their own mortality (Lupus. 2019 Mar. doi: 10.1177/0961203319839478. These observations spurred the Cincinnati investigators to develop a modified cognitive-behavioral therapy (CBT) protocol, known as TEACH, which they believe is the first CBT intervention to specifically target psychological problems in young people with childhood-onset SLE.
The TEACH program
TEACH (Treatment and Education Approach for Childhood-Onset Lupus) is a six-session program that teaches patients and caregivers self-advocacy, relaxation techniques, how to improve sleep hygiene, the importance of engaging in planned pleasant activities, and why taking medications matters. The program content differs depending upon whether the patient is an adolescent or young adult.
Results of a recently published small feasibility study were highly encouraging, showing that 83% of people who enrolled in the program completed it. Posttreatment assessment showed that patients had a marked decrease in depressive symptoms as measured by both the Children’s Depression Inventory and the Beck Depression Inventory. They also showed a significant reduction in fatigue. However, while favorable trends in terms of reduced pain and anxiety symptoms were noted, they didn’t achieve statistical significance (Pediatr Rheumatol Online J. 2019 Feb 18. doi: 10.1186/s12969-019-0307-8). The next step in this project is a planned controlled randomized trial.
A web-based medication adherence program
Researchers at Pennsylvania State University took a different approach. They created a publicly available educational website, www.facinglupustogether.com, aimed at improving self-management skills – and especially medication adherence – in teens and young adults with SLE.
The website contains eight modules: Making the transition and taking charge of my medications, Learning about lupus, Learning about lupus medications, Managing symptoms of lupus, How do I handle lupus and my family, How do I handle lupus and my friends, Lupus and stress, and My personal goals and how I will achieve them. Each takes about 10 minutes to complete.
In a pilot study, 37 patients tackled one module per week and were randomized to respond to questions about the weekly topic either in a journal or by discussing the key points in an online social media forum with other young people with SLE. The idea was to create an intervention that capitalizes on the excellent social media skills possessed by today’s youth. And indeed, incorporation of social media proved to be a winning strategy. Medication adherence for hydroxychloroquine in the group randomized to social media participation jumped from 50% in the 3 months prior to starting the program to 92% in the first 3 months post completion, whereas medication adherence didn’t change significantly in the other study arm. The social media group also experienced significant improvements in self-efficacy, sense of community, acceptance of illness, optimism and control over the future, and other measures of empowerment. The control group did not show significant change in any of these domains (Pediatr Rheumatol Online J. 2018 Mar 14. doi: 10.1186/s12969-018-0232-2).
The TEACH study was sponsored by the National Institutes of Health. The web-based medication adherence program pilot study was supported by the Lupus Foundation of America. What the two approaches share in common is a conviction that, when it comes to addressing pain, fatigue, diminished quality of life, and poor medication adherence in young patients with SLE: “Our medication prescription alone doesn’t do it,” Dr. Brunner said.
She reported having no financial conflicts regarding her presentation.
SAN FRANCISCO – – and therein lies the importance of introducing interventions beyond simply prescribing appropriate medications, Hermine I. Brunner, MD, asserted at an international congress on systemic lupus erythematosus.
Pilot studies conducted by her research group as well as others suggest that brief cognitive-behavioral interventions, web-based patient and caregiver education, and social media interactions significantly improve the fatigue and depression, poor quality of life, and lack of adherence to medication that are pervasive in young patients with SLE, according to Dr. Brunner, director of the division of rheumatology and professor of pediatrics at the University of Cincinnati and scientific director of the Pediatric Rheumatology Collaborative Study Group.
“Don’t misunderstand: I don’t think we can treat lupus simply with a psychological intervention at the bedside. However, I think doctors would be well advised to offer both psychological interventions and medication when they see young lupus patients, because without the psychological intervention the patients may not feel sufficiently at ease to take their medication. They will not get the benefit of the medications you’ve prescribed,” she said.
Patients with SLE take an average of eight medications daily. Their medication adherence rate is comparable to that of patients with diabetes or many other chronic diseases: that is to say, lousy. When investigators at the University of Texas MD Anderson Cancer Center, Houston, utilized an electronic monitoring system to chart adherence to prescribed oral medications in adults with SLE, they found that over the course of 2 years of follow-up only one-fourth of them had an adherence rate of 80% or better, which is the standard definition of adherence (Lupus. 2012 Oct;21[11]:1158-65).
Treatment adherence is particularly problematic in adolescents and young adults with SLE. They often have great difficulty in mastering the self-management skills required to stay on top of their disease when they have so much else going on during what is a vulnerable and challenging period of development, even for healthy youths.
The texting intervention
Dr. Brunner and her colleagues at Cincinnati Children’s Hospital Medical Center recognized the scope of the nonadherence problem early on. Years ago they started sending text messaging reminders of pending clinic visits to their patients who had a poor track record of showing up for appointments.
“We texted patients 2 weeks before their scheduled visit, 1 week before, and then again the day before the visit,” she explained.
This simple intervention resulted in a 47% reduction in missed appointments, compared with a control group. Also, text recipients were more likely to cancel appointments instead of simply not showing up, an important benefit from a practice management and scheduling standpoint (J Rheumatol. 2012 Jan;39[1]:174-9). Disappointingly, however, the text messaging intervention had no impact on adherence to prescribed use of hydroxychloroquine. This led the investigators to conduct a deeper dive into the roots of the nonadherence problem in childhood-onset lupus.
Disease control, quality of life
Dr. Brunner and her coworkers conducted an in-depth assessment of health-related quality of life in 50 patients with childhood-onset SLE over the course of 6 months. The results were surprising.
“When we looked at the correlation between disease control and quality of life, actually there was none,” according to the pediatric rheumatologist.
Instead, the investigators found that young patients with persistently low quality of life despite objectively measured good disease control scored high for fatigue and depressive symptoms (Lupus. 2018 Jan;27[1]:124-33). This led Dr. Brunner and her coinvestigators to consider developing a practical behavioral intervention to address these potentially modifiable predictors of impaired health-related quality of life in their patient population.
The need for novel approaches was highlighted in focus groups conducted by the investigators, in which patients and their primary caregivers emphasized that current therapeutic strategies don’t adequately address key problems of living with lupus, especially the prominent fatigue, pain, and depressed mood that hamper daily function and personal relationships. Patients said they don’t feel an immediate benefit from taking their medications, so why bother? And parents expressed frustration about how difficult it is to get their teenagers to understand the consequences of nonadherence when they’re at an age when they don’t yet even grasp the concept of their own mortality (Lupus. 2019 Mar. doi: 10.1177/0961203319839478. These observations spurred the Cincinnati investigators to develop a modified cognitive-behavioral therapy (CBT) protocol, known as TEACH, which they believe is the first CBT intervention to specifically target psychological problems in young people with childhood-onset SLE.
The TEACH program
TEACH (Treatment and Education Approach for Childhood-Onset Lupus) is a six-session program that teaches patients and caregivers self-advocacy, relaxation techniques, how to improve sleep hygiene, the importance of engaging in planned pleasant activities, and why taking medications matters. The program content differs depending upon whether the patient is an adolescent or young adult.
Results of a recently published small feasibility study were highly encouraging, showing that 83% of people who enrolled in the program completed it. Posttreatment assessment showed that patients had a marked decrease in depressive symptoms as measured by both the Children’s Depression Inventory and the Beck Depression Inventory. They also showed a significant reduction in fatigue. However, while favorable trends in terms of reduced pain and anxiety symptoms were noted, they didn’t achieve statistical significance (Pediatr Rheumatol Online J. 2019 Feb 18. doi: 10.1186/s12969-019-0307-8). The next step in this project is a planned controlled randomized trial.
A web-based medication adherence program
Researchers at Pennsylvania State University took a different approach. They created a publicly available educational website, www.facinglupustogether.com, aimed at improving self-management skills – and especially medication adherence – in teens and young adults with SLE.
The website contains eight modules: Making the transition and taking charge of my medications, Learning about lupus, Learning about lupus medications, Managing symptoms of lupus, How do I handle lupus and my family, How do I handle lupus and my friends, Lupus and stress, and My personal goals and how I will achieve them. Each takes about 10 minutes to complete.
In a pilot study, 37 patients tackled one module per week and were randomized to respond to questions about the weekly topic either in a journal or by discussing the key points in an online social media forum with other young people with SLE. The idea was to create an intervention that capitalizes on the excellent social media skills possessed by today’s youth. And indeed, incorporation of social media proved to be a winning strategy. Medication adherence for hydroxychloroquine in the group randomized to social media participation jumped from 50% in the 3 months prior to starting the program to 92% in the first 3 months post completion, whereas medication adherence didn’t change significantly in the other study arm. The social media group also experienced significant improvements in self-efficacy, sense of community, acceptance of illness, optimism and control over the future, and other measures of empowerment. The control group did not show significant change in any of these domains (Pediatr Rheumatol Online J. 2018 Mar 14. doi: 10.1186/s12969-018-0232-2).
The TEACH study was sponsored by the National Institutes of Health. The web-based medication adherence program pilot study was supported by the Lupus Foundation of America. What the two approaches share in common is a conviction that, when it comes to addressing pain, fatigue, diminished quality of life, and poor medication adherence in young patients with SLE: “Our medication prescription alone doesn’t do it,” Dr. Brunner said.
She reported having no financial conflicts regarding her presentation.
SAN FRANCISCO – – and therein lies the importance of introducing interventions beyond simply prescribing appropriate medications, Hermine I. Brunner, MD, asserted at an international congress on systemic lupus erythematosus.
Pilot studies conducted by her research group as well as others suggest that brief cognitive-behavioral interventions, web-based patient and caregiver education, and social media interactions significantly improve the fatigue and depression, poor quality of life, and lack of adherence to medication that are pervasive in young patients with SLE, according to Dr. Brunner, director of the division of rheumatology and professor of pediatrics at the University of Cincinnati and scientific director of the Pediatric Rheumatology Collaborative Study Group.
“Don’t misunderstand: I don’t think we can treat lupus simply with a psychological intervention at the bedside. However, I think doctors would be well advised to offer both psychological interventions and medication when they see young lupus patients, because without the psychological intervention the patients may not feel sufficiently at ease to take their medication. They will not get the benefit of the medications you’ve prescribed,” she said.
Patients with SLE take an average of eight medications daily. Their medication adherence rate is comparable to that of patients with diabetes or many other chronic diseases: that is to say, lousy. When investigators at the University of Texas MD Anderson Cancer Center, Houston, utilized an electronic monitoring system to chart adherence to prescribed oral medications in adults with SLE, they found that over the course of 2 years of follow-up only one-fourth of them had an adherence rate of 80% or better, which is the standard definition of adherence (Lupus. 2012 Oct;21[11]:1158-65).
Treatment adherence is particularly problematic in adolescents and young adults with SLE. They often have great difficulty in mastering the self-management skills required to stay on top of their disease when they have so much else going on during what is a vulnerable and challenging period of development, even for healthy youths.
The texting intervention
Dr. Brunner and her colleagues at Cincinnati Children’s Hospital Medical Center recognized the scope of the nonadherence problem early on. Years ago they started sending text messaging reminders of pending clinic visits to their patients who had a poor track record of showing up for appointments.
“We texted patients 2 weeks before their scheduled visit, 1 week before, and then again the day before the visit,” she explained.
This simple intervention resulted in a 47% reduction in missed appointments, compared with a control group. Also, text recipients were more likely to cancel appointments instead of simply not showing up, an important benefit from a practice management and scheduling standpoint (J Rheumatol. 2012 Jan;39[1]:174-9). Disappointingly, however, the text messaging intervention had no impact on adherence to prescribed use of hydroxychloroquine. This led the investigators to conduct a deeper dive into the roots of the nonadherence problem in childhood-onset lupus.
Disease control, quality of life
Dr. Brunner and her coworkers conducted an in-depth assessment of health-related quality of life in 50 patients with childhood-onset SLE over the course of 6 months. The results were surprising.
“When we looked at the correlation between disease control and quality of life, actually there was none,” according to the pediatric rheumatologist.
Instead, the investigators found that young patients with persistently low quality of life despite objectively measured good disease control scored high for fatigue and depressive symptoms (Lupus. 2018 Jan;27[1]:124-33). This led Dr. Brunner and her coinvestigators to consider developing a practical behavioral intervention to address these potentially modifiable predictors of impaired health-related quality of life in their patient population.
The need for novel approaches was highlighted in focus groups conducted by the investigators, in which patients and their primary caregivers emphasized that current therapeutic strategies don’t adequately address key problems of living with lupus, especially the prominent fatigue, pain, and depressed mood that hamper daily function and personal relationships. Patients said they don’t feel an immediate benefit from taking their medications, so why bother? And parents expressed frustration about how difficult it is to get their teenagers to understand the consequences of nonadherence when they’re at an age when they don’t yet even grasp the concept of their own mortality (Lupus. 2019 Mar. doi: 10.1177/0961203319839478. These observations spurred the Cincinnati investigators to develop a modified cognitive-behavioral therapy (CBT) protocol, known as TEACH, which they believe is the first CBT intervention to specifically target psychological problems in young people with childhood-onset SLE.
The TEACH program
TEACH (Treatment and Education Approach for Childhood-Onset Lupus) is a six-session program that teaches patients and caregivers self-advocacy, relaxation techniques, how to improve sleep hygiene, the importance of engaging in planned pleasant activities, and why taking medications matters. The program content differs depending upon whether the patient is an adolescent or young adult.
Results of a recently published small feasibility study were highly encouraging, showing that 83% of people who enrolled in the program completed it. Posttreatment assessment showed that patients had a marked decrease in depressive symptoms as measured by both the Children’s Depression Inventory and the Beck Depression Inventory. They also showed a significant reduction in fatigue. However, while favorable trends in terms of reduced pain and anxiety symptoms were noted, they didn’t achieve statistical significance (Pediatr Rheumatol Online J. 2019 Feb 18. doi: 10.1186/s12969-019-0307-8). The next step in this project is a planned controlled randomized trial.
A web-based medication adherence program
Researchers at Pennsylvania State University took a different approach. They created a publicly available educational website, www.facinglupustogether.com, aimed at improving self-management skills – and especially medication adherence – in teens and young adults with SLE.
The website contains eight modules: Making the transition and taking charge of my medications, Learning about lupus, Learning about lupus medications, Managing symptoms of lupus, How do I handle lupus and my family, How do I handle lupus and my friends, Lupus and stress, and My personal goals and how I will achieve them. Each takes about 10 minutes to complete.
In a pilot study, 37 patients tackled one module per week and were randomized to respond to questions about the weekly topic either in a journal or by discussing the key points in an online social media forum with other young people with SLE. The idea was to create an intervention that capitalizes on the excellent social media skills possessed by today’s youth. And indeed, incorporation of social media proved to be a winning strategy. Medication adherence for hydroxychloroquine in the group randomized to social media participation jumped from 50% in the 3 months prior to starting the program to 92% in the first 3 months post completion, whereas medication adherence didn’t change significantly in the other study arm. The social media group also experienced significant improvements in self-efficacy, sense of community, acceptance of illness, optimism and control over the future, and other measures of empowerment. The control group did not show significant change in any of these domains (Pediatr Rheumatol Online J. 2018 Mar 14. doi: 10.1186/s12969-018-0232-2).
The TEACH study was sponsored by the National Institutes of Health. The web-based medication adherence program pilot study was supported by the Lupus Foundation of America. What the two approaches share in common is a conviction that, when it comes to addressing pain, fatigue, diminished quality of life, and poor medication adherence in young patients with SLE: “Our medication prescription alone doesn’t do it,” Dr. Brunner said.
She reported having no financial conflicts regarding her presentation.
REPORTING FROM LUPUS 2019
FDA concerned about e-cigs/seizures in youth
the agency announced April 3.
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”
In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.
Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.
Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.
The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
the agency announced April 3.
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”
In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.
Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.
Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.
The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
the agency announced April 3.
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes. Most reports involved youth or young adults, and the reports have increased slightly since June 2018, the announcement says.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said FDA Commissioner Scott Gottlieb, MD, and Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a statement. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.”
In addition, the FDA is trying to determine whether any e-cigarette product-specific factors may be associated with the risk of seizures.
Seizures have been reported after a few puffs or up to 1 day after e-cigarette use and among first-time and experienced users. A few patients had a prior history of seizures or also used other substances, such as marijuana or amphetamines.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognized that not all of the cases may be reported,” Dr. Gottlieb and Dr. Abernethy said.
Although seizures are known side effects of nicotine toxicity and have been reported in the context of intentional or accidental swallowing of e-cigarette liquid, the voluntary reports of seizures occurring with vaping could represent a new safety issue, the FDA said.
The agency encouraged people to report cases via an online safety reporting portal. It also provided redacted case reports that involve vaping and seizures.
Valproate, topiramate prescribed in young women despite known teratogenicity risks
results of a retrospective analysis suggest.
Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.
Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.
Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.
Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.
“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.
The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.
Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).
Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).
The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.
However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.
UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
results of a retrospective analysis suggest.
Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.
Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.
Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.
Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.
“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.
The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.
Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).
Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).
The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.
However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.
UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
results of a retrospective analysis suggest.
Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.
Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.
Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.
Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.
“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.
The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.
Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).
Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).
The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.
However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.
UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
FROM JAMA NEUROLOGY
Key clinical point: Both valproate and topiramate are prescribed relatively often in women of childbearing age despite known teratogenic risks.
Major finding: Topiramate was the second- or third-most prescribed AED in the analyses. Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy.
Study details: Retrospective cohort study including nearly 47,000 women of childbearing age enrolled in claims databases between 2009 and 2013.
Disclosures: UCB Pharma sponsored the study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
Source: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
Adolescent psychiatric ED visits more than doubled in 4 years
a study found.
Visits by African American youth and Latino youth both increased by a significant amount, yet only a minority of all youth (16%) were seen by mental health professionals during their psychiatric ED visits.
“This study unmistakably reveals that adolescents are a population with urgent mental health needs,” Luther G. Kalb, PhD, of the Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute in Baltimore, and his colleagues reported in Pediatrics. “Not only were their visits the most acute, but their probability of suicidal attempt and/or self-harm increased as well,” a finding that matches recent national increases in suicidal ideation.
The researchers used the 2011-2015 National Hospital Ambulatory Medical Care Survey to analyze data on psychiatric ED visits among U.S. youth aged 6-24 years. A psychiatric visit was identified based on the patient’s reason for visit and the International Classification of Diseases, ninth revision, codes for mood, behavioral, or substance use disorders; psychosis; or other psychiatric reasons. Suicide attempt or intentional self-harm were identified with reason for visit codes.
Psychiatric ED visits among all youth increased 28%, from 31 to 40 visits per 1,000 U.S. youth, in the period from 2011 to 2015, a finding “heavily driven by 2015, in which the largest increase in visits was observed,” the authors noted.
The biggest jump occurred among adolescents, whose visits increased 54%, and among black and Latino patients, whose visits rose 53% and 91%, respectively. Adolescent suicide-related and self-injury ED visits more than doubled from 2011 to 2015, from 5 to 12 visits per 1,000 U.S. youth. They were the only age group to see an increase in odds of a suicide-related visit over time (odds ratio, 1.27, P less than .01)
“Ultimately, it is unclear if the findings represent a change in identification (by providers) or reporting (by patients or family members) of mental health in the ED, a shift in the epidemiology of psychiatric disorders in the United States, or fluctuations in referral patterns or service-seeking behavior,” Dr. Kalb and his associates reported.
Study limitations included “an inability to confirm diagnostic validity” and some missing data for visit acuity and race/ethnicity, they said.
The research was funded by the National Institute of Health, and in part by the National Institute of Mental Health Intramural Research program. The authors reported no relevant financial disclosures.
SOURCE: Kalb LG et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2018-2192.
Even though the “fast-paced, stimulating environment” of an emergency department is not the ideal setting for children and families to receive care for mental health concerns, it remains a crucial safety net – particularly for lower-income individuals – because so many children lack access to mental health services, Dr. Chun and his associates wrote in an accompanying editorial.
“Some of the factors contributing to deficiencies in ED preparedness include a lack of staff trained in the identification and management of acute mental health problems; safe and quiet spaces within the ED; appropriate milieu for respectful, safe care; policies and procedures for ensuring best practices and consistent care; professional expertise to evaluate children’s mental health problems; and access to appropriate and timely follow-up care.”
Yet rates of youth’s psychiatric visits to the ED continue to climb because of a combination of increasing awareness, decreasing stigma for care seeking, limited mental health services, a shortage of pediatric mental health providers, insufficient specialty services, and true increases in mental health needs.
Solving this problem will require multiple coordinated approaches, but innovative options already are being explored, such as integrating child psychiatry services into EDs and “instituting next-day or other timely mental health evaluations,” they wrote. Other approaches include telepsychiatry; bringing mental health resources into schools and clinics; mental health resource sharing among communities; and mobile crisis units that visit schools, homes, primary care clinics, and low-resourced EDs.
Finally, medical training programs must change to adapt to the increasing need for pediatric mental health needs. “Embracing mental health problems as a routine component of pediatric medicine may be part of the solution to addressing the crisis,” they wrote.
Thomas H. Chun, MD, MPH, and Susan J. Duffy, MD, MPH, are at the Hasbro Children’s Hospital in Providence, R.I., and Jacqueline Grupp-Phelan, MD, MPH, is at the University of California, San Francisco, Benioff Children’s Hospital. These comments are a summary of a commentary accompanying Kalb et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2019-0251. The physicians used no external funding and had no financial disclosures relevant to their commentary.
Even though the “fast-paced, stimulating environment” of an emergency department is not the ideal setting for children and families to receive care for mental health concerns, it remains a crucial safety net – particularly for lower-income individuals – because so many children lack access to mental health services, Dr. Chun and his associates wrote in an accompanying editorial.
“Some of the factors contributing to deficiencies in ED preparedness include a lack of staff trained in the identification and management of acute mental health problems; safe and quiet spaces within the ED; appropriate milieu for respectful, safe care; policies and procedures for ensuring best practices and consistent care; professional expertise to evaluate children’s mental health problems; and access to appropriate and timely follow-up care.”
Yet rates of youth’s psychiatric visits to the ED continue to climb because of a combination of increasing awareness, decreasing stigma for care seeking, limited mental health services, a shortage of pediatric mental health providers, insufficient specialty services, and true increases in mental health needs.
Solving this problem will require multiple coordinated approaches, but innovative options already are being explored, such as integrating child psychiatry services into EDs and “instituting next-day or other timely mental health evaluations,” they wrote. Other approaches include telepsychiatry; bringing mental health resources into schools and clinics; mental health resource sharing among communities; and mobile crisis units that visit schools, homes, primary care clinics, and low-resourced EDs.
Finally, medical training programs must change to adapt to the increasing need for pediatric mental health needs. “Embracing mental health problems as a routine component of pediatric medicine may be part of the solution to addressing the crisis,” they wrote.
Thomas H. Chun, MD, MPH, and Susan J. Duffy, MD, MPH, are at the Hasbro Children’s Hospital in Providence, R.I., and Jacqueline Grupp-Phelan, MD, MPH, is at the University of California, San Francisco, Benioff Children’s Hospital. These comments are a summary of a commentary accompanying Kalb et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2019-0251. The physicians used no external funding and had no financial disclosures relevant to their commentary.
Even though the “fast-paced, stimulating environment” of an emergency department is not the ideal setting for children and families to receive care for mental health concerns, it remains a crucial safety net – particularly for lower-income individuals – because so many children lack access to mental health services, Dr. Chun and his associates wrote in an accompanying editorial.
“Some of the factors contributing to deficiencies in ED preparedness include a lack of staff trained in the identification and management of acute mental health problems; safe and quiet spaces within the ED; appropriate milieu for respectful, safe care; policies and procedures for ensuring best practices and consistent care; professional expertise to evaluate children’s mental health problems; and access to appropriate and timely follow-up care.”
Yet rates of youth’s psychiatric visits to the ED continue to climb because of a combination of increasing awareness, decreasing stigma for care seeking, limited mental health services, a shortage of pediatric mental health providers, insufficient specialty services, and true increases in mental health needs.
Solving this problem will require multiple coordinated approaches, but innovative options already are being explored, such as integrating child psychiatry services into EDs and “instituting next-day or other timely mental health evaluations,” they wrote. Other approaches include telepsychiatry; bringing mental health resources into schools and clinics; mental health resource sharing among communities; and mobile crisis units that visit schools, homes, primary care clinics, and low-resourced EDs.
Finally, medical training programs must change to adapt to the increasing need for pediatric mental health needs. “Embracing mental health problems as a routine component of pediatric medicine may be part of the solution to addressing the crisis,” they wrote.
Thomas H. Chun, MD, MPH, and Susan J. Duffy, MD, MPH, are at the Hasbro Children’s Hospital in Providence, R.I., and Jacqueline Grupp-Phelan, MD, MPH, is at the University of California, San Francisco, Benioff Children’s Hospital. These comments are a summary of a commentary accompanying Kalb et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2019-0251. The physicians used no external funding and had no financial disclosures relevant to their commentary.
a study found.
Visits by African American youth and Latino youth both increased by a significant amount, yet only a minority of all youth (16%) were seen by mental health professionals during their psychiatric ED visits.
“This study unmistakably reveals that adolescents are a population with urgent mental health needs,” Luther G. Kalb, PhD, of the Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute in Baltimore, and his colleagues reported in Pediatrics. “Not only were their visits the most acute, but their probability of suicidal attempt and/or self-harm increased as well,” a finding that matches recent national increases in suicidal ideation.
The researchers used the 2011-2015 National Hospital Ambulatory Medical Care Survey to analyze data on psychiatric ED visits among U.S. youth aged 6-24 years. A psychiatric visit was identified based on the patient’s reason for visit and the International Classification of Diseases, ninth revision, codes for mood, behavioral, or substance use disorders; psychosis; or other psychiatric reasons. Suicide attempt or intentional self-harm were identified with reason for visit codes.
Psychiatric ED visits among all youth increased 28%, from 31 to 40 visits per 1,000 U.S. youth, in the period from 2011 to 2015, a finding “heavily driven by 2015, in which the largest increase in visits was observed,” the authors noted.
The biggest jump occurred among adolescents, whose visits increased 54%, and among black and Latino patients, whose visits rose 53% and 91%, respectively. Adolescent suicide-related and self-injury ED visits more than doubled from 2011 to 2015, from 5 to 12 visits per 1,000 U.S. youth. They were the only age group to see an increase in odds of a suicide-related visit over time (odds ratio, 1.27, P less than .01)
“Ultimately, it is unclear if the findings represent a change in identification (by providers) or reporting (by patients or family members) of mental health in the ED, a shift in the epidemiology of psychiatric disorders in the United States, or fluctuations in referral patterns or service-seeking behavior,” Dr. Kalb and his associates reported.
Study limitations included “an inability to confirm diagnostic validity” and some missing data for visit acuity and race/ethnicity, they said.
The research was funded by the National Institute of Health, and in part by the National Institute of Mental Health Intramural Research program. The authors reported no relevant financial disclosures.
SOURCE: Kalb LG et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2018-2192.
a study found.
Visits by African American youth and Latino youth both increased by a significant amount, yet only a minority of all youth (16%) were seen by mental health professionals during their psychiatric ED visits.
“This study unmistakably reveals that adolescents are a population with urgent mental health needs,” Luther G. Kalb, PhD, of the Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute in Baltimore, and his colleagues reported in Pediatrics. “Not only were their visits the most acute, but their probability of suicidal attempt and/or self-harm increased as well,” a finding that matches recent national increases in suicidal ideation.
The researchers used the 2011-2015 National Hospital Ambulatory Medical Care Survey to analyze data on psychiatric ED visits among U.S. youth aged 6-24 years. A psychiatric visit was identified based on the patient’s reason for visit and the International Classification of Diseases, ninth revision, codes for mood, behavioral, or substance use disorders; psychosis; or other psychiatric reasons. Suicide attempt or intentional self-harm were identified with reason for visit codes.
Psychiatric ED visits among all youth increased 28%, from 31 to 40 visits per 1,000 U.S. youth, in the period from 2011 to 2015, a finding “heavily driven by 2015, in which the largest increase in visits was observed,” the authors noted.
The biggest jump occurred among adolescents, whose visits increased 54%, and among black and Latino patients, whose visits rose 53% and 91%, respectively. Adolescent suicide-related and self-injury ED visits more than doubled from 2011 to 2015, from 5 to 12 visits per 1,000 U.S. youth. They were the only age group to see an increase in odds of a suicide-related visit over time (odds ratio, 1.27, P less than .01)
“Ultimately, it is unclear if the findings represent a change in identification (by providers) or reporting (by patients or family members) of mental health in the ED, a shift in the epidemiology of psychiatric disorders in the United States, or fluctuations in referral patterns or service-seeking behavior,” Dr. Kalb and his associates reported.
Study limitations included “an inability to confirm diagnostic validity” and some missing data for visit acuity and race/ethnicity, they said.
The research was funded by the National Institute of Health, and in part by the National Institute of Mental Health Intramural Research program. The authors reported no relevant financial disclosures.
SOURCE: Kalb LG et al. Pediatrics. 2019 Mar 18. doi: 10.1542/peds.2018-2192.
FROM PEDIATRICS
Hope for hyperhidrosis
Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise.
Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:
1. It occurs in eccrine dense areas (axilla, soles, palms or head).
2. It is bilateral and symmetrical.
3. It is absent nocturnally.
4. Its onset should be before age 25 years.
5. It occurs at least weekly.
6. There is a positive family history.
7. It impairs daily activities.
If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1
The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2
Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1
Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3
Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1
Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2
The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2
Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.
It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.
More studies are on the horizon, but finally there is hope for hyperhidrosis.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. Skin Appendage Disord. 2015 Mar;1(1):6-13.
2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.
3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.
Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise.
Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:
1. It occurs in eccrine dense areas (axilla, soles, palms or head).
2. It is bilateral and symmetrical.
3. It is absent nocturnally.
4. Its onset should be before age 25 years.
5. It occurs at least weekly.
6. There is a positive family history.
7. It impairs daily activities.
If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1
The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2
Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1
Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3
Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1
Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2
The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2
Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.
It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.
More studies are on the horizon, but finally there is hope for hyperhidrosis.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. Skin Appendage Disord. 2015 Mar;1(1):6-13.
2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.
3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.
Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise.
Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:
1. It occurs in eccrine dense areas (axilla, soles, palms or head).
2. It is bilateral and symmetrical.
3. It is absent nocturnally.
4. Its onset should be before age 25 years.
5. It occurs at least weekly.
6. There is a positive family history.
7. It impairs daily activities.
If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1
The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2
Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1
Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3
Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1
Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2
The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2
Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.
It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.
More studies are on the horizon, but finally there is hope for hyperhidrosis.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. Skin Appendage Disord. 2015 Mar;1(1):6-13.
2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.
3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.
FDA extends Dupixent indication for 12- to 17-year-olds
The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.”
Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.
While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.
FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”
With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”
Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.
Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”
These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.
“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”
The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications
The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.
The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.”
Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.
While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.
FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”
With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”
Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.
Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”
These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.
“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”
The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications
The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.
The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.”
Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.
While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.
FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”
With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”
Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.
Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”
These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.
“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”
The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications
The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.
Heart-harming toxins may hurt hookah smokers
Smoking a water pipe, or hookah, can result in significant inhalation of toxins and an increased risk for short- and long-term cardiovascular health problems, according to a scientific statement issued by the American Heart Association on March 8.
In the statement, published in the journal Circulation, Aruni Bhatnagar, PhD, of the University of Louisville (Ky.) and his colleagues reviewed the potential dangers of water pipe use and offered strategies for prevention.
Data from the 2016 National Youth Tobacco Survey showed that current use (defined as use within the past 30 days) of water pipes by high school students increased in a nonlinear trend from 4.1% in 2011 to 4.8% in 2016, with a peak of 9.4% in 2014. Water pipe tobacco is sold in flavors such as cherry, chocolate, and coffee that appeal to younger consumers, and epidemiology data suggest that youth view water pipes as safer than conventional cigarettes because the water “filters out toxins” according to the statement.
Findings from the National Adult Tobacco Survey showed an increase as well, from 1.5% during 2009-2010 to 3.2% during 2013-2014. Adults cite cultural and social influences, as well as psychological benefits of reduced stress and anger and improved concentration, which may be attributable to nicotine, the researchers noted.
Water pipe smoking involves placing charcoal briquettes on top of a tobacco-filled bowl with a stem immersed in water such that the smoke is pulled through and bubbles up through the water into a mouthpiece. and include tar, phenanthrene, carbon monoxide, heavy metals, and arsenic, as well as nicotine.
The patterns of exposure to toxins during water pipe smoking are unclear, the authors noted.
However, the risks for both short-term and long-term health effects are similar to those associated with cigarettes. “Overall, the short-term cardiovascular effects are consistent with the sympathomimetic effects of nicotine,” according to the statement.
Data on the long-term effects of water pipe smoking on cardiovascular health are limited, but “lifetime exposures exceeding 40 water pipe–years (2 water pipes per day for a total of 20 years or 1 water pipe for 40 years) are associated with a threefold increase in the odds of angiographically diagnosed coronary artery stenosis,” according to the statement. Additional research on long-term health effects may help guide regulation of water pipe products, the authors suggested.
The AHA statement encourages health care providers to take a proactive approach in addressing hookah use by asking patients about it, by advising those who use water pipes to quit, by assisting those who want to quit by providing counseling and social support, and by referring water pipe smokers to legitimate resources for information on the potential for addiction and health risks.
Dr. Bhatnagar received funding from the National Institutes of Health, but he had no other financial conflicts to disclose.
SOURCE: Bhatnagar A et al. Circulation. 2019 Mar 8. doi: 10.1161/CIR.0000000000000671.
Smoking a water pipe, or hookah, can result in significant inhalation of toxins and an increased risk for short- and long-term cardiovascular health problems, according to a scientific statement issued by the American Heart Association on March 8.
In the statement, published in the journal Circulation, Aruni Bhatnagar, PhD, of the University of Louisville (Ky.) and his colleagues reviewed the potential dangers of water pipe use and offered strategies for prevention.
Data from the 2016 National Youth Tobacco Survey showed that current use (defined as use within the past 30 days) of water pipes by high school students increased in a nonlinear trend from 4.1% in 2011 to 4.8% in 2016, with a peak of 9.4% in 2014. Water pipe tobacco is sold in flavors such as cherry, chocolate, and coffee that appeal to younger consumers, and epidemiology data suggest that youth view water pipes as safer than conventional cigarettes because the water “filters out toxins” according to the statement.
Findings from the National Adult Tobacco Survey showed an increase as well, from 1.5% during 2009-2010 to 3.2% during 2013-2014. Adults cite cultural and social influences, as well as psychological benefits of reduced stress and anger and improved concentration, which may be attributable to nicotine, the researchers noted.
Water pipe smoking involves placing charcoal briquettes on top of a tobacco-filled bowl with a stem immersed in water such that the smoke is pulled through and bubbles up through the water into a mouthpiece. and include tar, phenanthrene, carbon monoxide, heavy metals, and arsenic, as well as nicotine.
The patterns of exposure to toxins during water pipe smoking are unclear, the authors noted.
However, the risks for both short-term and long-term health effects are similar to those associated with cigarettes. “Overall, the short-term cardiovascular effects are consistent with the sympathomimetic effects of nicotine,” according to the statement.
Data on the long-term effects of water pipe smoking on cardiovascular health are limited, but “lifetime exposures exceeding 40 water pipe–years (2 water pipes per day for a total of 20 years or 1 water pipe for 40 years) are associated with a threefold increase in the odds of angiographically diagnosed coronary artery stenosis,” according to the statement. Additional research on long-term health effects may help guide regulation of water pipe products, the authors suggested.
The AHA statement encourages health care providers to take a proactive approach in addressing hookah use by asking patients about it, by advising those who use water pipes to quit, by assisting those who want to quit by providing counseling and social support, and by referring water pipe smokers to legitimate resources for information on the potential for addiction and health risks.
Dr. Bhatnagar received funding from the National Institutes of Health, but he had no other financial conflicts to disclose.
SOURCE: Bhatnagar A et al. Circulation. 2019 Mar 8. doi: 10.1161/CIR.0000000000000671.
Smoking a water pipe, or hookah, can result in significant inhalation of toxins and an increased risk for short- and long-term cardiovascular health problems, according to a scientific statement issued by the American Heart Association on March 8.
In the statement, published in the journal Circulation, Aruni Bhatnagar, PhD, of the University of Louisville (Ky.) and his colleagues reviewed the potential dangers of water pipe use and offered strategies for prevention.
Data from the 2016 National Youth Tobacco Survey showed that current use (defined as use within the past 30 days) of water pipes by high school students increased in a nonlinear trend from 4.1% in 2011 to 4.8% in 2016, with a peak of 9.4% in 2014. Water pipe tobacco is sold in flavors such as cherry, chocolate, and coffee that appeal to younger consumers, and epidemiology data suggest that youth view water pipes as safer than conventional cigarettes because the water “filters out toxins” according to the statement.
Findings from the National Adult Tobacco Survey showed an increase as well, from 1.5% during 2009-2010 to 3.2% during 2013-2014. Adults cite cultural and social influences, as well as psychological benefits of reduced stress and anger and improved concentration, which may be attributable to nicotine, the researchers noted.
Water pipe smoking involves placing charcoal briquettes on top of a tobacco-filled bowl with a stem immersed in water such that the smoke is pulled through and bubbles up through the water into a mouthpiece. and include tar, phenanthrene, carbon monoxide, heavy metals, and arsenic, as well as nicotine.
The patterns of exposure to toxins during water pipe smoking are unclear, the authors noted.
However, the risks for both short-term and long-term health effects are similar to those associated with cigarettes. “Overall, the short-term cardiovascular effects are consistent with the sympathomimetic effects of nicotine,” according to the statement.
Data on the long-term effects of water pipe smoking on cardiovascular health are limited, but “lifetime exposures exceeding 40 water pipe–years (2 water pipes per day for a total of 20 years or 1 water pipe for 40 years) are associated with a threefold increase in the odds of angiographically diagnosed coronary artery stenosis,” according to the statement. Additional research on long-term health effects may help guide regulation of water pipe products, the authors suggested.
The AHA statement encourages health care providers to take a proactive approach in addressing hookah use by asking patients about it, by advising those who use water pipes to quit, by assisting those who want to quit by providing counseling and social support, and by referring water pipe smokers to legitimate resources for information on the potential for addiction and health risks.
Dr. Bhatnagar received funding from the National Institutes of Health, but he had no other financial conflicts to disclose.
SOURCE: Bhatnagar A et al. Circulation. 2019 Mar 8. doi: 10.1161/CIR.0000000000000671.
FROM CIRCULATION
Human papillomavirus in 2019: An update on cervical cancer prevention and screening guidelines
About 12% of women worldwide are infected with human papillomavirus (HPV).1 Persistent HPV infection with high-risk strains such as HPV 6, 11, 16, and 18 cause nearly all cases of cervical cancer and some anal, vaginal, penile, and oropharyngeal cancers.2 An estimated 13,000 cases of invasive cervical cancer will be diagnosed this year in the United States alone.3
Up to 70% of HPV-related cervical cancer cases can be prevented with vaccination. A number of changes have been made to the vaccination schedule within the past few years—patients younger than 15 need only 2 rather than 3 doses, and the vaccine itself can be used in adults up to age 45.
Vaccination and routine cervical cancer screening are both necessary to prevent this disease3 along with effective family and patient counseling. Here, we discuss the most up-to-date HPV vaccination recommendations, current cervical cancer screening guidelines, counseling techniques that increase vaccination acceptance rates, and follow-up protocols for abnormal cervical cancer screening results.
TYPES OF HPV VACCINES
HPV immunization can prevent up to 70% of cases of cervical cancer due to HPV as well as 90% of genital warts.4 The US Food and Drug Administration (FDA) has approved 3 HPV vaccines:
- Gardasil 9 targets HPV types 6, 11, 16, and 18 along with 31, 33, 45, 52, 58—these cause 90% of cervical cancer cases and most cases of genital warts5—making it the most effective vaccine available; Gardasil 9 is the only HPV vaccine currently available in the United States
- The bivalent vaccine (Cervarix) targeted HPV 16 and 18 only, and was discontinued in the United States in 2016
- The quadrivalent HPV vaccine (Gardasil) targeted HPV 16 and 18 as well as 6 and 11, which cause most cases of genital warts; the last available doses in the United States expired in May 2017; it has been replaced by Gardasil 9.
The incidence of cervical cancer in the United States dropped 29% among 15- to 24-year-olds from 2003–2006 when HPV vaccination first started to 2011–2014.6
VACCINE DOSING RECOMMENDATIONS FOR PRIMARY PREVENTION
The Advisory Committee on Immunization Practices (ACIP) revised its HPV vaccine schedule in 2016, when it decreased the necessary doses from 3 to 2 for patients under age 15 and addressed the needs of special patient populations.7 In late 2018, the FDA approved the use of the vaccine in men and women up to age 45. However, no change in guidelines have yet been made (Table 1).
In females, the ACIP recommends starting HPV vaccination at age 11 or 12, but it can be given as early as age 9. A 2-dose schedule is recommended for the 9-valent vaccine before the patient’s 15th birthday (the second dose 6 to 12 months after the first).7 For females who initiate HPV vaccination between ages 15 and 45, a 3-dose schedule is necessary (at 0, 1 to 2, and 6 months).7,8
The change to a 2-dose schedule was prompted by an evaluation of girls ages 9 to 13 randomized to receive either a 2- or 3-dose schedule. Antibody responses with a 2-dose schedule were not inferior to those of young women (ages 16 to 26) who received all 3 doses.9 The geometric mean titer ratios remained noninferior throughout the study period of 36 months.
However, a loss of noninferiority was noted for HPV-18 by 24 months and for HPV-6 by 36 months.9 Thus, further studies are needed to understand the duration of protection with a 2-dose schedule. Nevertheless, decreasing the number of doses makes it a more convenient and cost-effective option for many families.
The recommendations are the same for males except for one notable difference: in males ages 21 to 26, vaccination is not routinely recommended by the ACIP, but rather it is considered a “permissive use” recommendation: ie, the vaccine should be offered and final decisions on administration be made after individualized discussion with the patient.10 Permissive-use status also means the vaccine may not be covered by health insurance. Even though the vaccine is now available to men and women until age 45, many insurance plans do not cover it after age 26.
Children of either sex with a history of sexual abuse should receive their first vaccine dose beginning at age 9.7
Immunocompromised patients should follow the 3-dose schedule regardless of their sex or the age when vaccination was initiated.10
For transgender patients and for men not previously vaccinated who have sex with men, the 3-dose schedule vaccine should be given by the age of 26 (this is a routine recommendation, not a permissive one).8
CHALLENGES OF VACCINATION
Effective patient and family counseling is important. Even though the first HPV vaccine was approved in 2006, only 34.9% of US adolescents were fully vaccinated by 2015. This was in part because providers did not recommend it, were unfamiliar with it, or had concerns about its safety,11,12 and in part because some parents refused it.
The physician must address any myths regarding HPV vaccination and ensure that parents and patients understand that HPV vaccine is safe and effective. Studies have shown that with high-quality recommendations (ie, the care provider strongly endorses the HPV vaccine, encourages same-day vaccination, and discusses cancer prevention), patients are 9 times more likely to start the HPV vaccination schedule and 3 times more likely to follow through with subsequent doses.13
Providing good family and patient education does not necessarily require spending more counseling time. A recent study showed that spending less time discussing the HPV vaccine can lead to better vaccine coverage.14 The study compared parent HPV vaccine counseling techniques and found that simply informing patients and their families that the HPV vaccine was due was associated with a higher vaccine acceptance rate than inviting conversations about it.14 When providers announced that the vaccine was due, assuming the parents were ready to vaccinate, there was a 5.4% increase in HPV vaccination coverage.14
Conversely, physicians who engaged parents in open-ended discussions about the HPV vaccine did not improve HPV vaccination coverage.14 The authors suggested that providers approach HPV vaccination as if they were counseling patients and families about the need to avoid second-hand smoke or the need to use car seats. If parents or patients resist the presumptive announcement approach, expanded counseling and shared decision-making are appropriate. This includes addressing misconceptions that parents and patients may have about the HPV vaccine. The American Cancer Society lists 8 facts to reference (Table 2).15
SECONDARY PREVENTION: CERVICAL CANCER SCREENING
Since the introduction of the Papanicolaou (Pap) test, US cervical cancer incidence rates have decreased by more than 60%.16 Because almost all cervical cancer is preventable with proper screening, all women ages 21 to 65 should be screened.
Currently, there are 3 options available for cervical cancer screening: the Pap-only test, the Pap-HPV cotest, and the high-risk HPV-only test (Table 3). The latter 2 options detect high-risk HPV genotypes.
Several organizations have screening algorithms that recommend when to use these tests, but the 3 that shape today’s standard of care in cervical cancer screening come from the American College of Obstetricians and Gynecologists (ACOG), the American Society for Colposcopy and Cervical Pathology (ASCCP), and US Preventive Services Task Force (USPSTF).17–19
Pap-only testing is performed every 3 years to screen for cervical neoplasia that might indicate premalignancy.
Pap-HPV cotesting is performed every 5 years in women older than 30 with past normal screening. Until 2018, all 3 organizations recommended cotesting as the preferred screening algorithm for women ages 30 to 65.17–19 Patients with a history of abnormal test results require more frequent testing as recommended by the ASCCP.18
The high-risk HPV-only test utilizes real-time polymerase chain reaction to detect HPV 16, HPV 18, and 12 other HPV genotypes. Only 2 tests are approved by the FDA as stand-alone cervical cancer screening tests—the Roche Cobas HPV test approved in 2014 and the Becton Dickinson Onclarity HPV assay approved in 2018. Other HPV tests that are used in a cotesting strategy should not be used for high-risk HPV-only testing because their performance characteristics may differ.
In 2015, the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study showed that 1 round of high-risk HPV-only screening for women older than 25 was more sensitive than Pap-only or cotesting for stage 3 cervical intraepithelial neoplasia or more severe disease (after 3 years of follow-up).20 Current guidelines from ASCCP18 and ACOG17 state that the high-risk HPV test can be repeated every 3 years (when used to screen by itself) if the woman is older than 25 and has had a normal test result.
If the HPV test result is positive for high-risk HPV 16 or 18 genotypes, then immediate colposcopy is indicated; women who test positive for one of the other 12 high-risk subtypes will need to undergo a Pap test to determine the appropriate follow-up (Figure 1).18,21
In 2018, the USPSTF updated its recommendations, noting that for women age 30 to 65, Pap-only testing every 3 years, cotesting every 5 years, or high-risk HPV-only testing every 5 years are all appropriate screening strategies, with the Pap-only or high-risk HPV-only screenings being preferred.19 This is in contrast to ACOG and ASCCP recommendations for cotesting every 5 years, with alternative options of Pap-only or HPV-only testing being done every 3 years.17,18
Is there a best screening protocol?
The USPSTF reviewed large randomized and observational studies to summarize the effectiveness of the 3 screening strategies and commissioned a decision analysis model to compare the risks, benefits, and costs of the 3 screening algorithms. The guideline statement notes both cotesting and high-risk HPV testing offer similar cancer detection rates: each prevents 1 additional cancer per 1,000 women screened as opposed to Pap-only testing.19
Also, tests that incorporate high-risk HPV screening may offer better detection of cervical adenocarcinoma (which has a worse prognosis than the more common squamous cell carcinoma type). However, both HPV-based screening strategies are more likely to require additional colposcopies for follow-up than Pap-only screening (1,630 colposcopies required for each cancer prevented with high-risk HPV alone, 1,635 with cotesting). Colposcopy is a simple office procedure that causes minimal discomfort to the patient.
The USPSTF guideline also differs in the recommended frequency of high-risk HPV-only testing; a high-risk HPV result should be repeated every 5 years if normal (as opposed to every 3 years as recommended by ACOG and ASCCP).19 The 5-year recommendation is based on analysis modeling, which suggests that performing high-risk HPV-only testing more frequently is unlikely to improve detection rates but will increase the number of screening tests and colposcopies.19
No trial has directly compared cotesting with high-risk HPV testing for more than 2 rounds of screening. The updated USPSTF recommendations are based on modeling estimates and expert opinion, which assesses cost and benefit vs harm in the long term. Also, no high-risk HPV test is currently FDA-approved for every-5-year screening when used by itself.
All 3 cervical cancer screening methods provide highly effective cancer prevention, so it is important for providers to choose the strategy that best fits their practice. The most critical aspect of screening is getting all women screened, no matter which method is used.
It is critical to remember that the screening intervals are intended for patients without symptoms. Those who have new concerns such as bleeding should have a diagnostic Pap done to evaluate their symptoms.
Follow-up of abnormal results
Regardless of the pathway chosen, appropriate follow-up of any abnormal test result is critical to the early detection of cancer. Established follow-up guidelines exist,22,23 but accessing this information can be difficult for the busy clinician. The ASCCP has a mobile phone application that outlines the action steps corresponding to the patient’s age and results of any combination of Pap or HPV testing. The app also includes the best screening algorithms for a particular patient.24
All guidelines agree that cervical cancer screening should start at age 21, regardless of HPV vaccination status or age of sexual initiation.17,18,25 Screening can be discontinued at age 65 for women with normal screening results in the prior decade (3 consecutive negative Pap results or 2 consecutive negative cotest results).23
For women who have had a total hysterectomy and no history of cervical neoplasia, screening should be stopped immediately after the procedure. However, several high-risk groups of women will need continued screening past the age of 65, or after a hysterectomy.
For a woman with a history of stage 2 cervical intraepithelial neoplasia or higher grade lesions, routine screening is continued for an additional 20 years, even if she is over age 65. Pap-only testing every 3 years is acceptable, because the role of HPV testing is unclear after hysterectomy.23 Prior guidelines suggested annual screening in these patients, so the change to every 3 years is notable. Many gynecologic oncologists will recommend that women with a history of cervical cancer continue annual screening indefinitely.
Within the first 2 to 3 years after treatment for high-grade dysplastic changes, annual follow-up is done by the gynecologic oncology team. Providers who offer follow-up during this time frame should keep in communication with the oncology team to ensure appropriate, individualized care. These recommendations are based on expert opinion, so variations in clinical practice may be seen.
Women infected with the human immunodeficiency virus can have Pap-only testing every 3 years, after a series of 3 normal annual Pap results.26 But screening does not stop at age 65.23,26 For patients who are immunosuppressed or have a history of diethylstilbestrol exposure, screening should be done annually indefinitely.23
- Bruni L, Diaz M, Castellsagué X, Ferrer E, Bosch FX, de Sanjosé S. Cervical human papillomavirus prevalence in 5 continents: meta-analysis of 1 million women with normal cytological findings. J Infect Dis 2010; 202(12):1789–1799. doi:10.1086/657321
- de Martel C, Ferlay J, Franceschi S, et al. Global burden of cancer attributable to infections in 2008: a review and synthetic analysis. Lancet Oncol 2012; 13(6):607–615. doi:10.1016/S1470-2045(12)70137-7
- American Cancer Society. Key statistics for cervical cancer. www.cancer.org/cancer/cervical-cancer/about/key-statistics.html. Accessed February 14, 2019.
- Thaxton L, Waxman AG. Cervical cancer prevention: immunization and screening 2015. Med Clin North Am 2015; 99(3):469–477. doi:10.1016/j.mcna.2015.01.003
- McNamara M, Batur P, Walsh JME, Johnson KM. HPV update: vaccination, screening, and associated disease. J Gen Intern Med 2016; 31(11):1360–1366. doi:10.1007/s11606-016-3725-z
- Guo F, Cofie LE, Berenson AB. Cervical cancer incidence in young US females after human papillomavirus vaccine introduction. Am J Prev Med 2018; 55(2):197–204. doi:10.1016/j.amepre.2018.03.013
- Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination—updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016; 65(49):1405–1408. doi:10.15585/mmwr.mm6549a5
- Centers for Disease Control and Prevention (CDC). Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV vaccine Information for persons who started an HPV vaccination series with quadrivalent or bivalent HPV vaccine. www.cdc.gov/hpv/downloads/9vhpv-guidance.pdf. Accessed February 14, 2019.
- Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA 2013; 309(17):1793–1802. doi:10.1001/jama.2013.1625
- Markowitz LE, Dunne EF, Saraiya M, et al; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014; 63(RR-05):1–30. pmid:25167164
- Thompson EL, Rosen BL, Vamos CA, Kadono M, Daley EM. Human papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents? J Adolesc Health 2017; 61(3):288–293. doi:10.1016/j.jadohealth.2017.05.015
- Reagan-Steiner S, Yankey D, Jeyarajah J, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years—United States, 2015. MMWR Morb Mortal Wkly Rep 2016; 65(33):850–858. doi:10.15585/mmwr.mm6533a4
- Gilkey MB, Calo WA, Moss JL, Shah PD, Marciniak MW, Brewer NT. Provider communication and HPV vaccination: The impact of recommendation quality. Vaccine 2016; 34(9):1187–1192. doi:10.1016/j.vaccine.2016.01.023
- Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements versus conversations to improve HPV vaccination coverage: a randomized trial. Pediatrics 2017; 139(1):e20161764. doi:10.1542/peds.2016-1764
- American Cancer Society. HPV vaccine facts. www.cancer.org/cancer/cancer-causes/infectious-agents/hpv/hpv-vaccine-facts-and-fears.html. Accessed February 14, 2019.
- National Cancer Institute; Chasan R, Manrow R. Cervical cancer. https://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=76. Accessed February 14, 2019.
- The American College of Obstetricians and Gynecologists (ACOG). Frequently asked questions. Cervical cancer screening. www.acog.org/Patients/FAQs/Cervical-Cancer-Screening. Accessed February 14, 2019.
- Saslow D, Solomon D, Lawson HW, et al; American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol 2012; 137(4):516–542. doi:10.1309/AJCPTGD94EVRSJCG
- US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, et al. Screening for cervical cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2018; 320(7):674–686. doi:10.1001/jama.2018.10897
- Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol 2015; 136(2):189–197. doi:10.1016/j.ygyno.2014.11.076
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol 2015; 125(2):330–337. doi:10.1097/AOG.0000000000000669
- Massad LS, Einstein MH, Huh WK, et al; 2012 ASCCP Consensus Guidelines Conference. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Obstet Gynecol 2013; 121(4):829–846. doi:10.1097/AOG.0b013e3182883a34
- Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 168: cervical cancer screening and prevention. Obstet Gynecol 2016; 128(4):e111–e130. doi:10.1097/AOG.0000000000001708
- ASCCP. Mobile app. http://www.asccp.org/store-detail2/asccp-mobile-app. Accessed February 14, 2019.
- USPSTF. Draft recommendation: cervical cancer: screening. www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2. Accessed February 14, 2019.
- Masur H, Brooks JT, Benson CA, Holmes KK, Pau AK, Kaplan JE; National Institutes of Health; Centers for Disease Control and Prevention; HIV Medicine Association of the Infectious Diseases Society of America. Prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: Updated guidelines from the Centers for Disease Control and Prevention, National Institutes of Health, and HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2014; 58(9):1308–1311. doi:10.1093/cid/ciu094
About 12% of women worldwide are infected with human papillomavirus (HPV).1 Persistent HPV infection with high-risk strains such as HPV 6, 11, 16, and 18 cause nearly all cases of cervical cancer and some anal, vaginal, penile, and oropharyngeal cancers.2 An estimated 13,000 cases of invasive cervical cancer will be diagnosed this year in the United States alone.3
Up to 70% of HPV-related cervical cancer cases can be prevented with vaccination. A number of changes have been made to the vaccination schedule within the past few years—patients younger than 15 need only 2 rather than 3 doses, and the vaccine itself can be used in adults up to age 45.
Vaccination and routine cervical cancer screening are both necessary to prevent this disease3 along with effective family and patient counseling. Here, we discuss the most up-to-date HPV vaccination recommendations, current cervical cancer screening guidelines, counseling techniques that increase vaccination acceptance rates, and follow-up protocols for abnormal cervical cancer screening results.
TYPES OF HPV VACCINES
HPV immunization can prevent up to 70% of cases of cervical cancer due to HPV as well as 90% of genital warts.4 The US Food and Drug Administration (FDA) has approved 3 HPV vaccines:
- Gardasil 9 targets HPV types 6, 11, 16, and 18 along with 31, 33, 45, 52, 58—these cause 90% of cervical cancer cases and most cases of genital warts5—making it the most effective vaccine available; Gardasil 9 is the only HPV vaccine currently available in the United States
- The bivalent vaccine (Cervarix) targeted HPV 16 and 18 only, and was discontinued in the United States in 2016
- The quadrivalent HPV vaccine (Gardasil) targeted HPV 16 and 18 as well as 6 and 11, which cause most cases of genital warts; the last available doses in the United States expired in May 2017; it has been replaced by Gardasil 9.
The incidence of cervical cancer in the United States dropped 29% among 15- to 24-year-olds from 2003–2006 when HPV vaccination first started to 2011–2014.6
VACCINE DOSING RECOMMENDATIONS FOR PRIMARY PREVENTION
The Advisory Committee on Immunization Practices (ACIP) revised its HPV vaccine schedule in 2016, when it decreased the necessary doses from 3 to 2 for patients under age 15 and addressed the needs of special patient populations.7 In late 2018, the FDA approved the use of the vaccine in men and women up to age 45. However, no change in guidelines have yet been made (Table 1).
In females, the ACIP recommends starting HPV vaccination at age 11 or 12, but it can be given as early as age 9. A 2-dose schedule is recommended for the 9-valent vaccine before the patient’s 15th birthday (the second dose 6 to 12 months after the first).7 For females who initiate HPV vaccination between ages 15 and 45, a 3-dose schedule is necessary (at 0, 1 to 2, and 6 months).7,8
The change to a 2-dose schedule was prompted by an evaluation of girls ages 9 to 13 randomized to receive either a 2- or 3-dose schedule. Antibody responses with a 2-dose schedule were not inferior to those of young women (ages 16 to 26) who received all 3 doses.9 The geometric mean titer ratios remained noninferior throughout the study period of 36 months.
However, a loss of noninferiority was noted for HPV-18 by 24 months and for HPV-6 by 36 months.9 Thus, further studies are needed to understand the duration of protection with a 2-dose schedule. Nevertheless, decreasing the number of doses makes it a more convenient and cost-effective option for many families.
The recommendations are the same for males except for one notable difference: in males ages 21 to 26, vaccination is not routinely recommended by the ACIP, but rather it is considered a “permissive use” recommendation: ie, the vaccine should be offered and final decisions on administration be made after individualized discussion with the patient.10 Permissive-use status also means the vaccine may not be covered by health insurance. Even though the vaccine is now available to men and women until age 45, many insurance plans do not cover it after age 26.
Children of either sex with a history of sexual abuse should receive their first vaccine dose beginning at age 9.7
Immunocompromised patients should follow the 3-dose schedule regardless of their sex or the age when vaccination was initiated.10
For transgender patients and for men not previously vaccinated who have sex with men, the 3-dose schedule vaccine should be given by the age of 26 (this is a routine recommendation, not a permissive one).8
CHALLENGES OF VACCINATION
Effective patient and family counseling is important. Even though the first HPV vaccine was approved in 2006, only 34.9% of US adolescents were fully vaccinated by 2015. This was in part because providers did not recommend it, were unfamiliar with it, or had concerns about its safety,11,12 and in part because some parents refused it.
The physician must address any myths regarding HPV vaccination and ensure that parents and patients understand that HPV vaccine is safe and effective. Studies have shown that with high-quality recommendations (ie, the care provider strongly endorses the HPV vaccine, encourages same-day vaccination, and discusses cancer prevention), patients are 9 times more likely to start the HPV vaccination schedule and 3 times more likely to follow through with subsequent doses.13
Providing good family and patient education does not necessarily require spending more counseling time. A recent study showed that spending less time discussing the HPV vaccine can lead to better vaccine coverage.14 The study compared parent HPV vaccine counseling techniques and found that simply informing patients and their families that the HPV vaccine was due was associated with a higher vaccine acceptance rate than inviting conversations about it.14 When providers announced that the vaccine was due, assuming the parents were ready to vaccinate, there was a 5.4% increase in HPV vaccination coverage.14
Conversely, physicians who engaged parents in open-ended discussions about the HPV vaccine did not improve HPV vaccination coverage.14 The authors suggested that providers approach HPV vaccination as if they were counseling patients and families about the need to avoid second-hand smoke or the need to use car seats. If parents or patients resist the presumptive announcement approach, expanded counseling and shared decision-making are appropriate. This includes addressing misconceptions that parents and patients may have about the HPV vaccine. The American Cancer Society lists 8 facts to reference (Table 2).15
SECONDARY PREVENTION: CERVICAL CANCER SCREENING
Since the introduction of the Papanicolaou (Pap) test, US cervical cancer incidence rates have decreased by more than 60%.16 Because almost all cervical cancer is preventable with proper screening, all women ages 21 to 65 should be screened.
Currently, there are 3 options available for cervical cancer screening: the Pap-only test, the Pap-HPV cotest, and the high-risk HPV-only test (Table 3). The latter 2 options detect high-risk HPV genotypes.
Several organizations have screening algorithms that recommend when to use these tests, but the 3 that shape today’s standard of care in cervical cancer screening come from the American College of Obstetricians and Gynecologists (ACOG), the American Society for Colposcopy and Cervical Pathology (ASCCP), and US Preventive Services Task Force (USPSTF).17–19
Pap-only testing is performed every 3 years to screen for cervical neoplasia that might indicate premalignancy.
Pap-HPV cotesting is performed every 5 years in women older than 30 with past normal screening. Until 2018, all 3 organizations recommended cotesting as the preferred screening algorithm for women ages 30 to 65.17–19 Patients with a history of abnormal test results require more frequent testing as recommended by the ASCCP.18
The high-risk HPV-only test utilizes real-time polymerase chain reaction to detect HPV 16, HPV 18, and 12 other HPV genotypes. Only 2 tests are approved by the FDA as stand-alone cervical cancer screening tests—the Roche Cobas HPV test approved in 2014 and the Becton Dickinson Onclarity HPV assay approved in 2018. Other HPV tests that are used in a cotesting strategy should not be used for high-risk HPV-only testing because their performance characteristics may differ.
In 2015, the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study showed that 1 round of high-risk HPV-only screening for women older than 25 was more sensitive than Pap-only or cotesting for stage 3 cervical intraepithelial neoplasia or more severe disease (after 3 years of follow-up).20 Current guidelines from ASCCP18 and ACOG17 state that the high-risk HPV test can be repeated every 3 years (when used to screen by itself) if the woman is older than 25 and has had a normal test result.
If the HPV test result is positive for high-risk HPV 16 or 18 genotypes, then immediate colposcopy is indicated; women who test positive for one of the other 12 high-risk subtypes will need to undergo a Pap test to determine the appropriate follow-up (Figure 1).18,21
In 2018, the USPSTF updated its recommendations, noting that for women age 30 to 65, Pap-only testing every 3 years, cotesting every 5 years, or high-risk HPV-only testing every 5 years are all appropriate screening strategies, with the Pap-only or high-risk HPV-only screenings being preferred.19 This is in contrast to ACOG and ASCCP recommendations for cotesting every 5 years, with alternative options of Pap-only or HPV-only testing being done every 3 years.17,18
Is there a best screening protocol?
The USPSTF reviewed large randomized and observational studies to summarize the effectiveness of the 3 screening strategies and commissioned a decision analysis model to compare the risks, benefits, and costs of the 3 screening algorithms. The guideline statement notes both cotesting and high-risk HPV testing offer similar cancer detection rates: each prevents 1 additional cancer per 1,000 women screened as opposed to Pap-only testing.19
Also, tests that incorporate high-risk HPV screening may offer better detection of cervical adenocarcinoma (which has a worse prognosis than the more common squamous cell carcinoma type). However, both HPV-based screening strategies are more likely to require additional colposcopies for follow-up than Pap-only screening (1,630 colposcopies required for each cancer prevented with high-risk HPV alone, 1,635 with cotesting). Colposcopy is a simple office procedure that causes minimal discomfort to the patient.
The USPSTF guideline also differs in the recommended frequency of high-risk HPV-only testing; a high-risk HPV result should be repeated every 5 years if normal (as opposed to every 3 years as recommended by ACOG and ASCCP).19 The 5-year recommendation is based on analysis modeling, which suggests that performing high-risk HPV-only testing more frequently is unlikely to improve detection rates but will increase the number of screening tests and colposcopies.19
No trial has directly compared cotesting with high-risk HPV testing for more than 2 rounds of screening. The updated USPSTF recommendations are based on modeling estimates and expert opinion, which assesses cost and benefit vs harm in the long term. Also, no high-risk HPV test is currently FDA-approved for every-5-year screening when used by itself.
All 3 cervical cancer screening methods provide highly effective cancer prevention, so it is important for providers to choose the strategy that best fits their practice. The most critical aspect of screening is getting all women screened, no matter which method is used.
It is critical to remember that the screening intervals are intended for patients without symptoms. Those who have new concerns such as bleeding should have a diagnostic Pap done to evaluate their symptoms.
Follow-up of abnormal results
Regardless of the pathway chosen, appropriate follow-up of any abnormal test result is critical to the early detection of cancer. Established follow-up guidelines exist,22,23 but accessing this information can be difficult for the busy clinician. The ASCCP has a mobile phone application that outlines the action steps corresponding to the patient’s age and results of any combination of Pap or HPV testing. The app also includes the best screening algorithms for a particular patient.24
All guidelines agree that cervical cancer screening should start at age 21, regardless of HPV vaccination status or age of sexual initiation.17,18,25 Screening can be discontinued at age 65 for women with normal screening results in the prior decade (3 consecutive negative Pap results or 2 consecutive negative cotest results).23
For women who have had a total hysterectomy and no history of cervical neoplasia, screening should be stopped immediately after the procedure. However, several high-risk groups of women will need continued screening past the age of 65, or after a hysterectomy.
For a woman with a history of stage 2 cervical intraepithelial neoplasia or higher grade lesions, routine screening is continued for an additional 20 years, even if she is over age 65. Pap-only testing every 3 years is acceptable, because the role of HPV testing is unclear after hysterectomy.23 Prior guidelines suggested annual screening in these patients, so the change to every 3 years is notable. Many gynecologic oncologists will recommend that women with a history of cervical cancer continue annual screening indefinitely.
Within the first 2 to 3 years after treatment for high-grade dysplastic changes, annual follow-up is done by the gynecologic oncology team. Providers who offer follow-up during this time frame should keep in communication with the oncology team to ensure appropriate, individualized care. These recommendations are based on expert opinion, so variations in clinical practice may be seen.
Women infected with the human immunodeficiency virus can have Pap-only testing every 3 years, after a series of 3 normal annual Pap results.26 But screening does not stop at age 65.23,26 For patients who are immunosuppressed or have a history of diethylstilbestrol exposure, screening should be done annually indefinitely.23
About 12% of women worldwide are infected with human papillomavirus (HPV).1 Persistent HPV infection with high-risk strains such as HPV 6, 11, 16, and 18 cause nearly all cases of cervical cancer and some anal, vaginal, penile, and oropharyngeal cancers.2 An estimated 13,000 cases of invasive cervical cancer will be diagnosed this year in the United States alone.3
Up to 70% of HPV-related cervical cancer cases can be prevented with vaccination. A number of changes have been made to the vaccination schedule within the past few years—patients younger than 15 need only 2 rather than 3 doses, and the vaccine itself can be used in adults up to age 45.
Vaccination and routine cervical cancer screening are both necessary to prevent this disease3 along with effective family and patient counseling. Here, we discuss the most up-to-date HPV vaccination recommendations, current cervical cancer screening guidelines, counseling techniques that increase vaccination acceptance rates, and follow-up protocols for abnormal cervical cancer screening results.
TYPES OF HPV VACCINES
HPV immunization can prevent up to 70% of cases of cervical cancer due to HPV as well as 90% of genital warts.4 The US Food and Drug Administration (FDA) has approved 3 HPV vaccines:
- Gardasil 9 targets HPV types 6, 11, 16, and 18 along with 31, 33, 45, 52, 58—these cause 90% of cervical cancer cases and most cases of genital warts5—making it the most effective vaccine available; Gardasil 9 is the only HPV vaccine currently available in the United States
- The bivalent vaccine (Cervarix) targeted HPV 16 and 18 only, and was discontinued in the United States in 2016
- The quadrivalent HPV vaccine (Gardasil) targeted HPV 16 and 18 as well as 6 and 11, which cause most cases of genital warts; the last available doses in the United States expired in May 2017; it has been replaced by Gardasil 9.
The incidence of cervical cancer in the United States dropped 29% among 15- to 24-year-olds from 2003–2006 when HPV vaccination first started to 2011–2014.6
VACCINE DOSING RECOMMENDATIONS FOR PRIMARY PREVENTION
The Advisory Committee on Immunization Practices (ACIP) revised its HPV vaccine schedule in 2016, when it decreased the necessary doses from 3 to 2 for patients under age 15 and addressed the needs of special patient populations.7 In late 2018, the FDA approved the use of the vaccine in men and women up to age 45. However, no change in guidelines have yet been made (Table 1).
In females, the ACIP recommends starting HPV vaccination at age 11 or 12, but it can be given as early as age 9. A 2-dose schedule is recommended for the 9-valent vaccine before the patient’s 15th birthday (the second dose 6 to 12 months after the first).7 For females who initiate HPV vaccination between ages 15 and 45, a 3-dose schedule is necessary (at 0, 1 to 2, and 6 months).7,8
The change to a 2-dose schedule was prompted by an evaluation of girls ages 9 to 13 randomized to receive either a 2- or 3-dose schedule. Antibody responses with a 2-dose schedule were not inferior to those of young women (ages 16 to 26) who received all 3 doses.9 The geometric mean titer ratios remained noninferior throughout the study period of 36 months.
However, a loss of noninferiority was noted for HPV-18 by 24 months and for HPV-6 by 36 months.9 Thus, further studies are needed to understand the duration of protection with a 2-dose schedule. Nevertheless, decreasing the number of doses makes it a more convenient and cost-effective option for many families.
The recommendations are the same for males except for one notable difference: in males ages 21 to 26, vaccination is not routinely recommended by the ACIP, but rather it is considered a “permissive use” recommendation: ie, the vaccine should be offered and final decisions on administration be made after individualized discussion with the patient.10 Permissive-use status also means the vaccine may not be covered by health insurance. Even though the vaccine is now available to men and women until age 45, many insurance plans do not cover it after age 26.
Children of either sex with a history of sexual abuse should receive their first vaccine dose beginning at age 9.7
Immunocompromised patients should follow the 3-dose schedule regardless of their sex or the age when vaccination was initiated.10
For transgender patients and for men not previously vaccinated who have sex with men, the 3-dose schedule vaccine should be given by the age of 26 (this is a routine recommendation, not a permissive one).8
CHALLENGES OF VACCINATION
Effective patient and family counseling is important. Even though the first HPV vaccine was approved in 2006, only 34.9% of US adolescents were fully vaccinated by 2015. This was in part because providers did not recommend it, were unfamiliar with it, or had concerns about its safety,11,12 and in part because some parents refused it.
The physician must address any myths regarding HPV vaccination and ensure that parents and patients understand that HPV vaccine is safe and effective. Studies have shown that with high-quality recommendations (ie, the care provider strongly endorses the HPV vaccine, encourages same-day vaccination, and discusses cancer prevention), patients are 9 times more likely to start the HPV vaccination schedule and 3 times more likely to follow through with subsequent doses.13
Providing good family and patient education does not necessarily require spending more counseling time. A recent study showed that spending less time discussing the HPV vaccine can lead to better vaccine coverage.14 The study compared parent HPV vaccine counseling techniques and found that simply informing patients and their families that the HPV vaccine was due was associated with a higher vaccine acceptance rate than inviting conversations about it.14 When providers announced that the vaccine was due, assuming the parents were ready to vaccinate, there was a 5.4% increase in HPV vaccination coverage.14
Conversely, physicians who engaged parents in open-ended discussions about the HPV vaccine did not improve HPV vaccination coverage.14 The authors suggested that providers approach HPV vaccination as if they were counseling patients and families about the need to avoid second-hand smoke or the need to use car seats. If parents or patients resist the presumptive announcement approach, expanded counseling and shared decision-making are appropriate. This includes addressing misconceptions that parents and patients may have about the HPV vaccine. The American Cancer Society lists 8 facts to reference (Table 2).15
SECONDARY PREVENTION: CERVICAL CANCER SCREENING
Since the introduction of the Papanicolaou (Pap) test, US cervical cancer incidence rates have decreased by more than 60%.16 Because almost all cervical cancer is preventable with proper screening, all women ages 21 to 65 should be screened.
Currently, there are 3 options available for cervical cancer screening: the Pap-only test, the Pap-HPV cotest, and the high-risk HPV-only test (Table 3). The latter 2 options detect high-risk HPV genotypes.
Several organizations have screening algorithms that recommend when to use these tests, but the 3 that shape today’s standard of care in cervical cancer screening come from the American College of Obstetricians and Gynecologists (ACOG), the American Society for Colposcopy and Cervical Pathology (ASCCP), and US Preventive Services Task Force (USPSTF).17–19
Pap-only testing is performed every 3 years to screen for cervical neoplasia that might indicate premalignancy.
Pap-HPV cotesting is performed every 5 years in women older than 30 with past normal screening. Until 2018, all 3 organizations recommended cotesting as the preferred screening algorithm for women ages 30 to 65.17–19 Patients with a history of abnormal test results require more frequent testing as recommended by the ASCCP.18
The high-risk HPV-only test utilizes real-time polymerase chain reaction to detect HPV 16, HPV 18, and 12 other HPV genotypes. Only 2 tests are approved by the FDA as stand-alone cervical cancer screening tests—the Roche Cobas HPV test approved in 2014 and the Becton Dickinson Onclarity HPV assay approved in 2018. Other HPV tests that are used in a cotesting strategy should not be used for high-risk HPV-only testing because their performance characteristics may differ.
In 2015, the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study showed that 1 round of high-risk HPV-only screening for women older than 25 was more sensitive than Pap-only or cotesting for stage 3 cervical intraepithelial neoplasia or more severe disease (after 3 years of follow-up).20 Current guidelines from ASCCP18 and ACOG17 state that the high-risk HPV test can be repeated every 3 years (when used to screen by itself) if the woman is older than 25 and has had a normal test result.
If the HPV test result is positive for high-risk HPV 16 or 18 genotypes, then immediate colposcopy is indicated; women who test positive for one of the other 12 high-risk subtypes will need to undergo a Pap test to determine the appropriate follow-up (Figure 1).18,21
In 2018, the USPSTF updated its recommendations, noting that for women age 30 to 65, Pap-only testing every 3 years, cotesting every 5 years, or high-risk HPV-only testing every 5 years are all appropriate screening strategies, with the Pap-only or high-risk HPV-only screenings being preferred.19 This is in contrast to ACOG and ASCCP recommendations for cotesting every 5 years, with alternative options of Pap-only or HPV-only testing being done every 3 years.17,18
Is there a best screening protocol?
The USPSTF reviewed large randomized and observational studies to summarize the effectiveness of the 3 screening strategies and commissioned a decision analysis model to compare the risks, benefits, and costs of the 3 screening algorithms. The guideline statement notes both cotesting and high-risk HPV testing offer similar cancer detection rates: each prevents 1 additional cancer per 1,000 women screened as opposed to Pap-only testing.19
Also, tests that incorporate high-risk HPV screening may offer better detection of cervical adenocarcinoma (which has a worse prognosis than the more common squamous cell carcinoma type). However, both HPV-based screening strategies are more likely to require additional colposcopies for follow-up than Pap-only screening (1,630 colposcopies required for each cancer prevented with high-risk HPV alone, 1,635 with cotesting). Colposcopy is a simple office procedure that causes minimal discomfort to the patient.
The USPSTF guideline also differs in the recommended frequency of high-risk HPV-only testing; a high-risk HPV result should be repeated every 5 years if normal (as opposed to every 3 years as recommended by ACOG and ASCCP).19 The 5-year recommendation is based on analysis modeling, which suggests that performing high-risk HPV-only testing more frequently is unlikely to improve detection rates but will increase the number of screening tests and colposcopies.19
No trial has directly compared cotesting with high-risk HPV testing for more than 2 rounds of screening. The updated USPSTF recommendations are based on modeling estimates and expert opinion, which assesses cost and benefit vs harm in the long term. Also, no high-risk HPV test is currently FDA-approved for every-5-year screening when used by itself.
All 3 cervical cancer screening methods provide highly effective cancer prevention, so it is important for providers to choose the strategy that best fits their practice. The most critical aspect of screening is getting all women screened, no matter which method is used.
It is critical to remember that the screening intervals are intended for patients without symptoms. Those who have new concerns such as bleeding should have a diagnostic Pap done to evaluate their symptoms.
Follow-up of abnormal results
Regardless of the pathway chosen, appropriate follow-up of any abnormal test result is critical to the early detection of cancer. Established follow-up guidelines exist,22,23 but accessing this information can be difficult for the busy clinician. The ASCCP has a mobile phone application that outlines the action steps corresponding to the patient’s age and results of any combination of Pap or HPV testing. The app also includes the best screening algorithms for a particular patient.24
All guidelines agree that cervical cancer screening should start at age 21, regardless of HPV vaccination status or age of sexual initiation.17,18,25 Screening can be discontinued at age 65 for women with normal screening results in the prior decade (3 consecutive negative Pap results or 2 consecutive negative cotest results).23
For women who have had a total hysterectomy and no history of cervical neoplasia, screening should be stopped immediately after the procedure. However, several high-risk groups of women will need continued screening past the age of 65, or after a hysterectomy.
For a woman with a history of stage 2 cervical intraepithelial neoplasia or higher grade lesions, routine screening is continued for an additional 20 years, even if she is over age 65. Pap-only testing every 3 years is acceptable, because the role of HPV testing is unclear after hysterectomy.23 Prior guidelines suggested annual screening in these patients, so the change to every 3 years is notable. Many gynecologic oncologists will recommend that women with a history of cervical cancer continue annual screening indefinitely.
Within the first 2 to 3 years after treatment for high-grade dysplastic changes, annual follow-up is done by the gynecologic oncology team. Providers who offer follow-up during this time frame should keep in communication with the oncology team to ensure appropriate, individualized care. These recommendations are based on expert opinion, so variations in clinical practice may be seen.
Women infected with the human immunodeficiency virus can have Pap-only testing every 3 years, after a series of 3 normal annual Pap results.26 But screening does not stop at age 65.23,26 For patients who are immunosuppressed or have a history of diethylstilbestrol exposure, screening should be done annually indefinitely.23
- Bruni L, Diaz M, Castellsagué X, Ferrer E, Bosch FX, de Sanjosé S. Cervical human papillomavirus prevalence in 5 continents: meta-analysis of 1 million women with normal cytological findings. J Infect Dis 2010; 202(12):1789–1799. doi:10.1086/657321
- de Martel C, Ferlay J, Franceschi S, et al. Global burden of cancer attributable to infections in 2008: a review and synthetic analysis. Lancet Oncol 2012; 13(6):607–615. doi:10.1016/S1470-2045(12)70137-7
- American Cancer Society. Key statistics for cervical cancer. www.cancer.org/cancer/cervical-cancer/about/key-statistics.html. Accessed February 14, 2019.
- Thaxton L, Waxman AG. Cervical cancer prevention: immunization and screening 2015. Med Clin North Am 2015; 99(3):469–477. doi:10.1016/j.mcna.2015.01.003
- McNamara M, Batur P, Walsh JME, Johnson KM. HPV update: vaccination, screening, and associated disease. J Gen Intern Med 2016; 31(11):1360–1366. doi:10.1007/s11606-016-3725-z
- Guo F, Cofie LE, Berenson AB. Cervical cancer incidence in young US females after human papillomavirus vaccine introduction. Am J Prev Med 2018; 55(2):197–204. doi:10.1016/j.amepre.2018.03.013
- Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination—updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016; 65(49):1405–1408. doi:10.15585/mmwr.mm6549a5
- Centers for Disease Control and Prevention (CDC). Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV vaccine Information for persons who started an HPV vaccination series with quadrivalent or bivalent HPV vaccine. www.cdc.gov/hpv/downloads/9vhpv-guidance.pdf. Accessed February 14, 2019.
- Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA 2013; 309(17):1793–1802. doi:10.1001/jama.2013.1625
- Markowitz LE, Dunne EF, Saraiya M, et al; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014; 63(RR-05):1–30. pmid:25167164
- Thompson EL, Rosen BL, Vamos CA, Kadono M, Daley EM. Human papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents? J Adolesc Health 2017; 61(3):288–293. doi:10.1016/j.jadohealth.2017.05.015
- Reagan-Steiner S, Yankey D, Jeyarajah J, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years—United States, 2015. MMWR Morb Mortal Wkly Rep 2016; 65(33):850–858. doi:10.15585/mmwr.mm6533a4
- Gilkey MB, Calo WA, Moss JL, Shah PD, Marciniak MW, Brewer NT. Provider communication and HPV vaccination: The impact of recommendation quality. Vaccine 2016; 34(9):1187–1192. doi:10.1016/j.vaccine.2016.01.023
- Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements versus conversations to improve HPV vaccination coverage: a randomized trial. Pediatrics 2017; 139(1):e20161764. doi:10.1542/peds.2016-1764
- American Cancer Society. HPV vaccine facts. www.cancer.org/cancer/cancer-causes/infectious-agents/hpv/hpv-vaccine-facts-and-fears.html. Accessed February 14, 2019.
- National Cancer Institute; Chasan R, Manrow R. Cervical cancer. https://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=76. Accessed February 14, 2019.
- The American College of Obstetricians and Gynecologists (ACOG). Frequently asked questions. Cervical cancer screening. www.acog.org/Patients/FAQs/Cervical-Cancer-Screening. Accessed February 14, 2019.
- Saslow D, Solomon D, Lawson HW, et al; American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol 2012; 137(4):516–542. doi:10.1309/AJCPTGD94EVRSJCG
- US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, et al. Screening for cervical cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2018; 320(7):674–686. doi:10.1001/jama.2018.10897
- Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol 2015; 136(2):189–197. doi:10.1016/j.ygyno.2014.11.076
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol 2015; 125(2):330–337. doi:10.1097/AOG.0000000000000669
- Massad LS, Einstein MH, Huh WK, et al; 2012 ASCCP Consensus Guidelines Conference. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Obstet Gynecol 2013; 121(4):829–846. doi:10.1097/AOG.0b013e3182883a34
- Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 168: cervical cancer screening and prevention. Obstet Gynecol 2016; 128(4):e111–e130. doi:10.1097/AOG.0000000000001708
- ASCCP. Mobile app. http://www.asccp.org/store-detail2/asccp-mobile-app. Accessed February 14, 2019.
- USPSTF. Draft recommendation: cervical cancer: screening. www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2. Accessed February 14, 2019.
- Masur H, Brooks JT, Benson CA, Holmes KK, Pau AK, Kaplan JE; National Institutes of Health; Centers for Disease Control and Prevention; HIV Medicine Association of the Infectious Diseases Society of America. Prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: Updated guidelines from the Centers for Disease Control and Prevention, National Institutes of Health, and HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2014; 58(9):1308–1311. doi:10.1093/cid/ciu094
- Bruni L, Diaz M, Castellsagué X, Ferrer E, Bosch FX, de Sanjosé S. Cervical human papillomavirus prevalence in 5 continents: meta-analysis of 1 million women with normal cytological findings. J Infect Dis 2010; 202(12):1789–1799. doi:10.1086/657321
- de Martel C, Ferlay J, Franceschi S, et al. Global burden of cancer attributable to infections in 2008: a review and synthetic analysis. Lancet Oncol 2012; 13(6):607–615. doi:10.1016/S1470-2045(12)70137-7
- American Cancer Society. Key statistics for cervical cancer. www.cancer.org/cancer/cervical-cancer/about/key-statistics.html. Accessed February 14, 2019.
- Thaxton L, Waxman AG. Cervical cancer prevention: immunization and screening 2015. Med Clin North Am 2015; 99(3):469–477. doi:10.1016/j.mcna.2015.01.003
- McNamara M, Batur P, Walsh JME, Johnson KM. HPV update: vaccination, screening, and associated disease. J Gen Intern Med 2016; 31(11):1360–1366. doi:10.1007/s11606-016-3725-z
- Guo F, Cofie LE, Berenson AB. Cervical cancer incidence in young US females after human papillomavirus vaccine introduction. Am J Prev Med 2018; 55(2):197–204. doi:10.1016/j.amepre.2018.03.013
- Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination—updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016; 65(49):1405–1408. doi:10.15585/mmwr.mm6549a5
- Centers for Disease Control and Prevention (CDC). Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV vaccine Information for persons who started an HPV vaccination series with quadrivalent or bivalent HPV vaccine. www.cdc.gov/hpv/downloads/9vhpv-guidance.pdf. Accessed February 14, 2019.
- Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA 2013; 309(17):1793–1802. doi:10.1001/jama.2013.1625
- Markowitz LE, Dunne EF, Saraiya M, et al; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014; 63(RR-05):1–30. pmid:25167164
- Thompson EL, Rosen BL, Vamos CA, Kadono M, Daley EM. Human papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents? J Adolesc Health 2017; 61(3):288–293. doi:10.1016/j.jadohealth.2017.05.015
- Reagan-Steiner S, Yankey D, Jeyarajah J, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years—United States, 2015. MMWR Morb Mortal Wkly Rep 2016; 65(33):850–858. doi:10.15585/mmwr.mm6533a4
- Gilkey MB, Calo WA, Moss JL, Shah PD, Marciniak MW, Brewer NT. Provider communication and HPV vaccination: The impact of recommendation quality. Vaccine 2016; 34(9):1187–1192. doi:10.1016/j.vaccine.2016.01.023
- Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements versus conversations to improve HPV vaccination coverage: a randomized trial. Pediatrics 2017; 139(1):e20161764. doi:10.1542/peds.2016-1764
- American Cancer Society. HPV vaccine facts. www.cancer.org/cancer/cancer-causes/infectious-agents/hpv/hpv-vaccine-facts-and-fears.html. Accessed February 14, 2019.
- National Cancer Institute; Chasan R, Manrow R. Cervical cancer. https://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=76. Accessed February 14, 2019.
- The American College of Obstetricians and Gynecologists (ACOG). Frequently asked questions. Cervical cancer screening. www.acog.org/Patients/FAQs/Cervical-Cancer-Screening. Accessed February 14, 2019.
- Saslow D, Solomon D, Lawson HW, et al; American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol 2012; 137(4):516–542. doi:10.1309/AJCPTGD94EVRSJCG
- US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, et al. Screening for cervical cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2018; 320(7):674–686. doi:10.1001/jama.2018.10897
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- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol 2015; 125(2):330–337. doi:10.1097/AOG.0000000000000669
- Massad LS, Einstein MH, Huh WK, et al; 2012 ASCCP Consensus Guidelines Conference. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Obstet Gynecol 2013; 121(4):829–846. doi:10.1097/AOG.0b013e3182883a34
- Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 168: cervical cancer screening and prevention. Obstet Gynecol 2016; 128(4):e111–e130. doi:10.1097/AOG.0000000000001708
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KEY POINTS
- Immunization against HPV can prevent up to 70% of HPV-related cervical cancer cases.
- Gardasil 9 is the only HPV vaccine currently available in the United States and is now approved for use in males and females between the ages of 9 and 45.
- In girls and boys younger than 15, a 2-dose schedule is recommended; patients ages 15 through 45 require 3 doses.
- Vaccine acceptance rates are highest when primary care providers announce that the vaccine is due rather than invite open-ended discussions.
- Regular cervical cancer screening is an important preventive tool and should be performed using the Papanicolaou (Pap) test, the high-risk HPV-only test, or the Pap-HPV cotest.
