Legalization of marijuana and youths’ attitudes toward its use

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Legalization of marijuana and youths’ attitudes toward its use

The legal status of marijuana has changed a great deal during the last 4 decades. In the United States, several states have legalized the use of marijuana to treat several medical conditions. Some states have decriminalized marijuana possession, and several have legalized marijuana for recreational use by adults. These changes have contributed to a growing misperception among young people that marijuana is harmless or not as risky as other illicit substances.

In this article, I explore the effect the legalization of marijuana has had on young peoples’ attitudes toward its use.

Marijuana use among adolescents

Among adolescents, marijuana is the most commonly used illicit substance, after alcohol.1 According to data from the 2019 Monitoring the Future Survey, while past month, past year, and lifetime marijuana use among 8th and 10th graders remained steady from 2018 to 2019, daily marijuana use among these adolescents increased.2 This survey also reported increases in adolescent marijuana vaping from 2018 to 2019.2 Further, the percentage of adolescents who think that the regular use of marijuana is risky has been trending down since the mid-2000s.2

Youth substance use rates depend on numerous factors, including legal status, availability, ease of access to the substance, and perception of harm.3 Although the legalization of marijuana for recreational use has been for adults only, based on rates of tobacco and alcohol use in adolescents (both of which are legal for adults), the legalization of marijuana is likely to have implications for adolescents.4

Adverse effects among adolescents

During adolescence, the brain is still developing, and marijuana use during this time could cause decreased cognitive functioning, especially executive functions.4 Marijuana use by adolescents also has been associated with4,5:

  • an increased risk of mental health disorders, including depression, anxiety, and psychosis, particularly among adolescents at higher risk, such as those with a family history of psychiatric illness
  • a decline in school performance
  • an increased school dropout rate
  • an increased risk of marijuana de­pen­dence
  • an elevated rate of engaging in risky behaviors.

Factors by which the legalization of marijuana might increase its use among adolescents include4:

  • perceived decreased risk of marijuana use
  • increased availability
  • lower cost
  • decreased fear of legal consequences of marijuana use.

Increased parental use is an indirect way in which legalization of marijuana for adult recreational use might increase use in youth.

Continue to: What the evidence says

 

 

What the evidence says

Colorado legalized marijuana for medical use in 2000, and for adult recreational use in 2014. A 2012 study of adolescents receiving substance abuse treatment in Colorado found diversion of medical marijuana to these adolescents was common.6 This study also reported that compared with those who did not use medical marijuana, adolescents who used medical marijuana had an earlier age of regular marijuana use, more marijuana use disorder symptoms, and more symptoms of conduct disorder.6 However, data from the US Substance Abuse and Mental Health Services Administration7 and from the Colorado Department of Public Health & Environment8 suggest that marijuana use among adolescents has not increased since legalization in Colorado.

In 2012, voters in Washington state legalized marijuana for recreational use. In 2013, Moreno et al9 interviewed college students in Washington, where marijuana had just been legalized, and Wisconsin, where it had not. In both states, most participants indicated that legalization would not change their attitude towards use. A small proportion of students felt that legalization would signify an endorsement of marijuana, and they were likely to perceive it as safe to use.

In an analysis of data on more than 250,000 students in 8th, 10th, and 12th grade, Cerdá et al10 found that after legalization in Washington, the perceived harmfulness of marijuana decreased and marijuana use increased among 8th and 10th graders in Washington; however, there were no significant differences noted among adolescents in Colorado.

In 2010, voters in California passed legislation to decriminalize marijuana. In an analysis of data from 8th, 10th, and 12th graders in California, Miech et al11 found a positive correlation between decriminalization and increases in youth future marijuana use. They also found that compared with their peers in other states, 12thgraders in California were more likely to have used marijuana in the last 30 days, less likely to perceive marijuana use as a health risk, and less likely to disapprove of its use.11

Although some studies have suggested that legalization of marijuana might increase use among adolescents, limitations of these studies include that they relied on self-reported use by adolescents, and they did not evaluate adolescent populations outside of school settings.

Continue to: Addressing adolescents' marijuana use

 

 

Addressing adolescents’ marijuana use

Strategies for preventing or reducing marijuana use among adolescents might include imposing restrictions and passing stricter laws on the sale of marijuana to individuals age <21, regulating marijuana advertising, increasing adolescent substance use prevention program initiatives, and educating youth about the negative effects of marijuana. Further research is needed to clearly establish if the legalization of marijuana for adult recreational use will increase its use among adolescents.

References

1. US Department of Health & Human Services. Marijuana use in adolescence. https://www.hhs.gov/ash/oah/adolescent-development/substance-use/marijuana/index.html. Updated April 19, 2019. Accessed January 15, 2020.
2. University of Michigan Institute for Social Research. National adolescent drug trends in 2019: Findings released. http://monitoringthefuture.org//pressreleases/19drugpr.pdf. Updated December 18, 2019. Accessed January 13, 2020.
3. Ammerman S, Ryan S, William P; Committee on Substance Abuse, the Committee on Adolescence. The impact of marijuana policies on youth: clinical, research, and legal update. Pediatrics. 2015;135(3):584-587.
4. Hopfer C. Implications of marijuana legalization for adolescent substance use. Subst Abus. 2014;35(4):331-335.
5. Silins E, Horwood LJ, Patton GC, et al. Young adult sequelae of adolescent cannabis use: an integrative analysis. Lancet Psychiatry. 2014;1(4):286-293.
6. Salomonsen-Sautel S, Sakai JT, Thurstone C, et al. Medical marijuana use among adolescents in substance abuse treatment. J Am Acad Child Adolesc Psychiatry. 2012;51(7):694-702.
7. US Department of Health & Human Services. Substance Abuse and Mental Health Services Administration. National Survey on Drug Use and Health: Comparison of 2014-2015 and 2015-2016 Population Percentages (50 States and the District of Columbia). https://www.samhsa.gov/data/sites/default/files/NSDUHsaeShortTermCHG2016/NSDUHsaeShortTermCHG2016.htm. Accessed January 15, 2020.
8. Colorado Department of Public Health & Environment. Data Brief: Colorado youth marijuana use 2017. https://drive.google.com/file/d/1AX_2RWWgygGXtGpAGoOMTe84Crzsv62T/view. Accessed January 15, 2020.
9. Moreno MA, Whitehill JM, Quach V, et al. Marijuana experiences, voting behaviors, and early perspectives regarding marijuana legalization among college students from 2 states. J Am Coll Health. 2016;64(1):9-18.
10. Cerdá M, Wall M, Feng T, et al. Association of state recreational marijuana laws with adolescent marijuana use. JAMA Pediatrics. 2017;171(2):142-149.
11. Miech RA, Johnston L, O’Malley PM, et al. Trends in use of marijuana and attitudes toward marijuana among youth before and after decriminalization: the case of California 2007-2013. Int J Drug Policy. 2015;26(4):336-344.

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The legal status of marijuana has changed a great deal during the last 4 decades. In the United States, several states have legalized the use of marijuana to treat several medical conditions. Some states have decriminalized marijuana possession, and several have legalized marijuana for recreational use by adults. These changes have contributed to a growing misperception among young people that marijuana is harmless or not as risky as other illicit substances.

In this article, I explore the effect the legalization of marijuana has had on young peoples’ attitudes toward its use.

Marijuana use among adolescents

Among adolescents, marijuana is the most commonly used illicit substance, after alcohol.1 According to data from the 2019 Monitoring the Future Survey, while past month, past year, and lifetime marijuana use among 8th and 10th graders remained steady from 2018 to 2019, daily marijuana use among these adolescents increased.2 This survey also reported increases in adolescent marijuana vaping from 2018 to 2019.2 Further, the percentage of adolescents who think that the regular use of marijuana is risky has been trending down since the mid-2000s.2

Youth substance use rates depend on numerous factors, including legal status, availability, ease of access to the substance, and perception of harm.3 Although the legalization of marijuana for recreational use has been for adults only, based on rates of tobacco and alcohol use in adolescents (both of which are legal for adults), the legalization of marijuana is likely to have implications for adolescents.4

Adverse effects among adolescents

During adolescence, the brain is still developing, and marijuana use during this time could cause decreased cognitive functioning, especially executive functions.4 Marijuana use by adolescents also has been associated with4,5:

  • an increased risk of mental health disorders, including depression, anxiety, and psychosis, particularly among adolescents at higher risk, such as those with a family history of psychiatric illness
  • a decline in school performance
  • an increased school dropout rate
  • an increased risk of marijuana de­pen­dence
  • an elevated rate of engaging in risky behaviors.

Factors by which the legalization of marijuana might increase its use among adolescents include4:

  • perceived decreased risk of marijuana use
  • increased availability
  • lower cost
  • decreased fear of legal consequences of marijuana use.

Increased parental use is an indirect way in which legalization of marijuana for adult recreational use might increase use in youth.

Continue to: What the evidence says

 

 

What the evidence says

Colorado legalized marijuana for medical use in 2000, and for adult recreational use in 2014. A 2012 study of adolescents receiving substance abuse treatment in Colorado found diversion of medical marijuana to these adolescents was common.6 This study also reported that compared with those who did not use medical marijuana, adolescents who used medical marijuana had an earlier age of regular marijuana use, more marijuana use disorder symptoms, and more symptoms of conduct disorder.6 However, data from the US Substance Abuse and Mental Health Services Administration7 and from the Colorado Department of Public Health & Environment8 suggest that marijuana use among adolescents has not increased since legalization in Colorado.

In 2012, voters in Washington state legalized marijuana for recreational use. In 2013, Moreno et al9 interviewed college students in Washington, where marijuana had just been legalized, and Wisconsin, where it had not. In both states, most participants indicated that legalization would not change their attitude towards use. A small proportion of students felt that legalization would signify an endorsement of marijuana, and they were likely to perceive it as safe to use.

In an analysis of data on more than 250,000 students in 8th, 10th, and 12th grade, Cerdá et al10 found that after legalization in Washington, the perceived harmfulness of marijuana decreased and marijuana use increased among 8th and 10th graders in Washington; however, there were no significant differences noted among adolescents in Colorado.

In 2010, voters in California passed legislation to decriminalize marijuana. In an analysis of data from 8th, 10th, and 12th graders in California, Miech et al11 found a positive correlation between decriminalization and increases in youth future marijuana use. They also found that compared with their peers in other states, 12thgraders in California were more likely to have used marijuana in the last 30 days, less likely to perceive marijuana use as a health risk, and less likely to disapprove of its use.11

Although some studies have suggested that legalization of marijuana might increase use among adolescents, limitations of these studies include that they relied on self-reported use by adolescents, and they did not evaluate adolescent populations outside of school settings.

Continue to: Addressing adolescents' marijuana use

 

 

Addressing adolescents’ marijuana use

Strategies for preventing or reducing marijuana use among adolescents might include imposing restrictions and passing stricter laws on the sale of marijuana to individuals age <21, regulating marijuana advertising, increasing adolescent substance use prevention program initiatives, and educating youth about the negative effects of marijuana. Further research is needed to clearly establish if the legalization of marijuana for adult recreational use will increase its use among adolescents.

The legal status of marijuana has changed a great deal during the last 4 decades. In the United States, several states have legalized the use of marijuana to treat several medical conditions. Some states have decriminalized marijuana possession, and several have legalized marijuana for recreational use by adults. These changes have contributed to a growing misperception among young people that marijuana is harmless or not as risky as other illicit substances.

In this article, I explore the effect the legalization of marijuana has had on young peoples’ attitudes toward its use.

Marijuana use among adolescents

Among adolescents, marijuana is the most commonly used illicit substance, after alcohol.1 According to data from the 2019 Monitoring the Future Survey, while past month, past year, and lifetime marijuana use among 8th and 10th graders remained steady from 2018 to 2019, daily marijuana use among these adolescents increased.2 This survey also reported increases in adolescent marijuana vaping from 2018 to 2019.2 Further, the percentage of adolescents who think that the regular use of marijuana is risky has been trending down since the mid-2000s.2

Youth substance use rates depend on numerous factors, including legal status, availability, ease of access to the substance, and perception of harm.3 Although the legalization of marijuana for recreational use has been for adults only, based on rates of tobacco and alcohol use in adolescents (both of which are legal for adults), the legalization of marijuana is likely to have implications for adolescents.4

Adverse effects among adolescents

During adolescence, the brain is still developing, and marijuana use during this time could cause decreased cognitive functioning, especially executive functions.4 Marijuana use by adolescents also has been associated with4,5:

  • an increased risk of mental health disorders, including depression, anxiety, and psychosis, particularly among adolescents at higher risk, such as those with a family history of psychiatric illness
  • a decline in school performance
  • an increased school dropout rate
  • an increased risk of marijuana de­pen­dence
  • an elevated rate of engaging in risky behaviors.

Factors by which the legalization of marijuana might increase its use among adolescents include4:

  • perceived decreased risk of marijuana use
  • increased availability
  • lower cost
  • decreased fear of legal consequences of marijuana use.

Increased parental use is an indirect way in which legalization of marijuana for adult recreational use might increase use in youth.

Continue to: What the evidence says

 

 

What the evidence says

Colorado legalized marijuana for medical use in 2000, and for adult recreational use in 2014. A 2012 study of adolescents receiving substance abuse treatment in Colorado found diversion of medical marijuana to these adolescents was common.6 This study also reported that compared with those who did not use medical marijuana, adolescents who used medical marijuana had an earlier age of regular marijuana use, more marijuana use disorder symptoms, and more symptoms of conduct disorder.6 However, data from the US Substance Abuse and Mental Health Services Administration7 and from the Colorado Department of Public Health & Environment8 suggest that marijuana use among adolescents has not increased since legalization in Colorado.

In 2012, voters in Washington state legalized marijuana for recreational use. In 2013, Moreno et al9 interviewed college students in Washington, where marijuana had just been legalized, and Wisconsin, where it had not. In both states, most participants indicated that legalization would not change their attitude towards use. A small proportion of students felt that legalization would signify an endorsement of marijuana, and they were likely to perceive it as safe to use.

In an analysis of data on more than 250,000 students in 8th, 10th, and 12th grade, Cerdá et al10 found that after legalization in Washington, the perceived harmfulness of marijuana decreased and marijuana use increased among 8th and 10th graders in Washington; however, there were no significant differences noted among adolescents in Colorado.

In 2010, voters in California passed legislation to decriminalize marijuana. In an analysis of data from 8th, 10th, and 12th graders in California, Miech et al11 found a positive correlation between decriminalization and increases in youth future marijuana use. They also found that compared with their peers in other states, 12thgraders in California were more likely to have used marijuana in the last 30 days, less likely to perceive marijuana use as a health risk, and less likely to disapprove of its use.11

Although some studies have suggested that legalization of marijuana might increase use among adolescents, limitations of these studies include that they relied on self-reported use by adolescents, and they did not evaluate adolescent populations outside of school settings.

Continue to: Addressing adolescents' marijuana use

 

 

Addressing adolescents’ marijuana use

Strategies for preventing or reducing marijuana use among adolescents might include imposing restrictions and passing stricter laws on the sale of marijuana to individuals age <21, regulating marijuana advertising, increasing adolescent substance use prevention program initiatives, and educating youth about the negative effects of marijuana. Further research is needed to clearly establish if the legalization of marijuana for adult recreational use will increase its use among adolescents.

References

1. US Department of Health & Human Services. Marijuana use in adolescence. https://www.hhs.gov/ash/oah/adolescent-development/substance-use/marijuana/index.html. Updated April 19, 2019. Accessed January 15, 2020.
2. University of Michigan Institute for Social Research. National adolescent drug trends in 2019: Findings released. http://monitoringthefuture.org//pressreleases/19drugpr.pdf. Updated December 18, 2019. Accessed January 13, 2020.
3. Ammerman S, Ryan S, William P; Committee on Substance Abuse, the Committee on Adolescence. The impact of marijuana policies on youth: clinical, research, and legal update. Pediatrics. 2015;135(3):584-587.
4. Hopfer C. Implications of marijuana legalization for adolescent substance use. Subst Abus. 2014;35(4):331-335.
5. Silins E, Horwood LJ, Patton GC, et al. Young adult sequelae of adolescent cannabis use: an integrative analysis. Lancet Psychiatry. 2014;1(4):286-293.
6. Salomonsen-Sautel S, Sakai JT, Thurstone C, et al. Medical marijuana use among adolescents in substance abuse treatment. J Am Acad Child Adolesc Psychiatry. 2012;51(7):694-702.
7. US Department of Health & Human Services. Substance Abuse and Mental Health Services Administration. National Survey on Drug Use and Health: Comparison of 2014-2015 and 2015-2016 Population Percentages (50 States and the District of Columbia). https://www.samhsa.gov/data/sites/default/files/NSDUHsaeShortTermCHG2016/NSDUHsaeShortTermCHG2016.htm. Accessed January 15, 2020.
8. Colorado Department of Public Health & Environment. Data Brief: Colorado youth marijuana use 2017. https://drive.google.com/file/d/1AX_2RWWgygGXtGpAGoOMTe84Crzsv62T/view. Accessed January 15, 2020.
9. Moreno MA, Whitehill JM, Quach V, et al. Marijuana experiences, voting behaviors, and early perspectives regarding marijuana legalization among college students from 2 states. J Am Coll Health. 2016;64(1):9-18.
10. Cerdá M, Wall M, Feng T, et al. Association of state recreational marijuana laws with adolescent marijuana use. JAMA Pediatrics. 2017;171(2):142-149.
11. Miech RA, Johnston L, O’Malley PM, et al. Trends in use of marijuana and attitudes toward marijuana among youth before and after decriminalization: the case of California 2007-2013. Int J Drug Policy. 2015;26(4):336-344.

References

1. US Department of Health & Human Services. Marijuana use in adolescence. https://www.hhs.gov/ash/oah/adolescent-development/substance-use/marijuana/index.html. Updated April 19, 2019. Accessed January 15, 2020.
2. University of Michigan Institute for Social Research. National adolescent drug trends in 2019: Findings released. http://monitoringthefuture.org//pressreleases/19drugpr.pdf. Updated December 18, 2019. Accessed January 13, 2020.
3. Ammerman S, Ryan S, William P; Committee on Substance Abuse, the Committee on Adolescence. The impact of marijuana policies on youth: clinical, research, and legal update. Pediatrics. 2015;135(3):584-587.
4. Hopfer C. Implications of marijuana legalization for adolescent substance use. Subst Abus. 2014;35(4):331-335.
5. Silins E, Horwood LJ, Patton GC, et al. Young adult sequelae of adolescent cannabis use: an integrative analysis. Lancet Psychiatry. 2014;1(4):286-293.
6. Salomonsen-Sautel S, Sakai JT, Thurstone C, et al. Medical marijuana use among adolescents in substance abuse treatment. J Am Acad Child Adolesc Psychiatry. 2012;51(7):694-702.
7. US Department of Health & Human Services. Substance Abuse and Mental Health Services Administration. National Survey on Drug Use and Health: Comparison of 2014-2015 and 2015-2016 Population Percentages (50 States and the District of Columbia). https://www.samhsa.gov/data/sites/default/files/NSDUHsaeShortTermCHG2016/NSDUHsaeShortTermCHG2016.htm. Accessed January 15, 2020.
8. Colorado Department of Public Health & Environment. Data Brief: Colorado youth marijuana use 2017. https://drive.google.com/file/d/1AX_2RWWgygGXtGpAGoOMTe84Crzsv62T/view. Accessed January 15, 2020.
9. Moreno MA, Whitehill JM, Quach V, et al. Marijuana experiences, voting behaviors, and early perspectives regarding marijuana legalization among college students from 2 states. J Am Coll Health. 2016;64(1):9-18.
10. Cerdá M, Wall M, Feng T, et al. Association of state recreational marijuana laws with adolescent marijuana use. JAMA Pediatrics. 2017;171(2):142-149.
11. Miech RA, Johnston L, O’Malley PM, et al. Trends in use of marijuana and attitudes toward marijuana among youth before and after decriminalization: the case of California 2007-2013. Int J Drug Policy. 2015;26(4):336-344.

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The Lowdown on Low-Dose Naltrexone

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Low-dose naltrexone (LDN) has shown efficacy in off-label treatment of a variety of inflammatory diseases ranging from Crohn disease to multiple sclerosis.1 There are limited data about the use of LDN in dermatology, but reports regarding how it works as an anti-inflammatory agent have been published.1,2

Naltrexone is an opioid receptor antagonist that originally was approved by the US Food and Drug Administration to treat addiction to alcohol, opiates, and heroin.2 The dose of naltrexone to treat addiction ranges from 50 to 100 mg/d, and at these levels the effects of opioids are blocked for 24 hours; however, the dosing for LDN is much lower, ranging from 1.5 to 4.5 mg/d.3 At this low dose, naltrexone partially binds to various opioid receptors, leading to a temporary blockade.4 One of the downstream effects of this opioid receptor blockade is a paradoxical increase in endogenous endorphins.3

In addition to opioid blockage, lower doses of naltrexone have anti-inflammatory effects by inhibiting nonopioid receptors. Naltrexone blocks toll-like receptor 4, which is found on keratinocytes and also on macrophages such as microglia.5 These macrophages also contain inflammatory compounds such as tumor necrosis factor α and IL-6. Low-dose naltrexone can suppress levels of these inflammatory markers. It is important to note that these anti-inflammatory effects have not been observed at the standard higher doses of naltrexone.1

When to Use

Low-dose naltrexone is a treatment option for inflammatory dermatologic conditions. A recent review of the literature outlined the use of LDN in a variety of inflammatory skin conditions. Improvement was noted in patients with Hailey-Hailey disease, lichen planopilaris, and various types of pruritus (ie, aquagenic, cholestatic, uremic, atopic dermatitis related).3 A case report of LDN successfully treating a patient with psoriasis also has been published.6 We often use LDN at the University of Wisconsin (Madison, Wisconsin) to treat patients with psoriasis. Ekelem et al3 also discussed patients with skin conditions that either had no response or worsened with naltrexone treatment, including various types of pruritus (ie, uremic, mycosis fungoides related, other causes of pruritus). Importantly, in the majority of cases without an improved response, the dose used was 50 mg/d.3 Higher doses of naltrexone are not known to have anti-inflammatory effects.

Low-dose naltrexone can be considered as a treatment option in patients with contraindications to other systemic anti-inflammatory treatments; for example, patients with a history of malignancy may prefer to avoid treatment with biologic agents. Low-dose naltrexone also can be considered as a treatment option in patients who are uncomfortable with the side-effect profiles of other systemic anti-inflammatory treatments, such as the risk for leukemias and lymphomas associated with biologic agents, the risk for liver toxicity with methotrexate, or the risk for hyperlipidemia with acitretin.

 

 

How to Monitor

The following monitoring information is adapted from the practice of Apple Bodemer, MD, a board-certified dermatologist at the University of Wisconsin (Madison, Wisconsin) who also is fellowship trained in integrative medicine.

There is a paucity of published data about LDN dosing for inflammatory skin diseases. However, prescribers should be aware that LDN can alter thyroid hormone levels, especially in patients with autoimmune thyroid disease. If a thyroid-stimulating hormone (TSH) level within reference range has not been noted in the last year, consider screening with a TSH test and also assessing for a personal or family history of thyroid disease. If the TSH level is within reference range, there generally is no need to monitor while treating with LDN. Consider checking TSH levels every 4 months in patients with thyroid disease while they are on LDN therapy and be sure to educate them about symptoms of hyperthyroidism.

Side Effects

Low-dose naltrexone has a minimal side-effect profile with self-limited side effects that often resolve within approximately 1 week. One of the most commonly reported side effects is sleep disturbance with vivid dreams, which has been reported in 37% of participants.1 If your patients experience this side effect, you can reassure them that it improves with time. You also can switch to morning dosing to try and alleviate sleep disturbances at night. Another possible side effect is gastrointestinal tract upset. Importantly, there is no known abuse potential for LDN.1 To stop LDN, patients should be stable for 6 to 12 months, and there is no need to wean them off it.

Cost and Availability

Because use of LDN in dermatology is considered off label and it is not approved by the US Food and Drug Administration to treat any medical conditions, it must be prescribed through a compounding pharmacy, usually without insurance coverage. The monthly cost is approximately $30 depending on the pharmacy (unpublished data), which may be cost prohibitive for patients, so it is important to counsel them about price before starting treatment.

Final Thoughts

Low-dose naltrexone is an alternative treatment option that can be considered in patients with inflammatory skin diseases. It has a favorable side-effect profile, especially compared to other systemic anti-inflammatory agents; however, additional studies are needed to learn more about its safety and efficacy. If patients ask you about LDN, the information provided here can guide you with how it works and how to prescribe it.

References
  1. Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33:451-459.
  2. Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337.
  3. Ekelem C, Juhasz M, Khera P, et al. Utility of naltrexone treatment for chronic inflammatory dermatologic conditions: a systematic review. JAMA Dermatol. 2019;155:229-236.
  4. Bihari B. Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS. AIDS Patient Care. 1995;9:3.
  5. Lee B, Elston DM. The uses of naltrexone in dermatologic conditions [published online December 21, 2018]. J Am Acad Dermatol. 2019;80:1746-1752.
  6. Bridgman AC, Kirchhof MG. Treatment of psoriasis vulgaris using low-dose naltrexone. JAAD Case Rep. 2018;4:827-829.
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From the Department of Dermatology, University of Wisconsin Hospital and Clinics, Madison.

The author reports no conflict of interest.

Correspondence: Nadine Shabeeb, MD, MPH, One S Park, 7th Floor, Madison, WI 53715 ([email protected]).

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The author reports no conflict of interest.

Correspondence: Nadine Shabeeb, MD, MPH, One S Park, 7th Floor, Madison, WI 53715 ([email protected]).

Author and Disclosure Information

From the Department of Dermatology, University of Wisconsin Hospital and Clinics, Madison.

The author reports no conflict of interest.

Correspondence: Nadine Shabeeb, MD, MPH, One S Park, 7th Floor, Madison, WI 53715 ([email protected]).

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Low-dose naltrexone (LDN) has shown efficacy in off-label treatment of a variety of inflammatory diseases ranging from Crohn disease to multiple sclerosis.1 There are limited data about the use of LDN in dermatology, but reports regarding how it works as an anti-inflammatory agent have been published.1,2

Naltrexone is an opioid receptor antagonist that originally was approved by the US Food and Drug Administration to treat addiction to alcohol, opiates, and heroin.2 The dose of naltrexone to treat addiction ranges from 50 to 100 mg/d, and at these levels the effects of opioids are blocked for 24 hours; however, the dosing for LDN is much lower, ranging from 1.5 to 4.5 mg/d.3 At this low dose, naltrexone partially binds to various opioid receptors, leading to a temporary blockade.4 One of the downstream effects of this opioid receptor blockade is a paradoxical increase in endogenous endorphins.3

In addition to opioid blockage, lower doses of naltrexone have anti-inflammatory effects by inhibiting nonopioid receptors. Naltrexone blocks toll-like receptor 4, which is found on keratinocytes and also on macrophages such as microglia.5 These macrophages also contain inflammatory compounds such as tumor necrosis factor α and IL-6. Low-dose naltrexone can suppress levels of these inflammatory markers. It is important to note that these anti-inflammatory effects have not been observed at the standard higher doses of naltrexone.1

When to Use

Low-dose naltrexone is a treatment option for inflammatory dermatologic conditions. A recent review of the literature outlined the use of LDN in a variety of inflammatory skin conditions. Improvement was noted in patients with Hailey-Hailey disease, lichen planopilaris, and various types of pruritus (ie, aquagenic, cholestatic, uremic, atopic dermatitis related).3 A case report of LDN successfully treating a patient with psoriasis also has been published.6 We often use LDN at the University of Wisconsin (Madison, Wisconsin) to treat patients with psoriasis. Ekelem et al3 also discussed patients with skin conditions that either had no response or worsened with naltrexone treatment, including various types of pruritus (ie, uremic, mycosis fungoides related, other causes of pruritus). Importantly, in the majority of cases without an improved response, the dose used was 50 mg/d.3 Higher doses of naltrexone are not known to have anti-inflammatory effects.

Low-dose naltrexone can be considered as a treatment option in patients with contraindications to other systemic anti-inflammatory treatments; for example, patients with a history of malignancy may prefer to avoid treatment with biologic agents. Low-dose naltrexone also can be considered as a treatment option in patients who are uncomfortable with the side-effect profiles of other systemic anti-inflammatory treatments, such as the risk for leukemias and lymphomas associated with biologic agents, the risk for liver toxicity with methotrexate, or the risk for hyperlipidemia with acitretin.

 

 

How to Monitor

The following monitoring information is adapted from the practice of Apple Bodemer, MD, a board-certified dermatologist at the University of Wisconsin (Madison, Wisconsin) who also is fellowship trained in integrative medicine.

There is a paucity of published data about LDN dosing for inflammatory skin diseases. However, prescribers should be aware that LDN can alter thyroid hormone levels, especially in patients with autoimmune thyroid disease. If a thyroid-stimulating hormone (TSH) level within reference range has not been noted in the last year, consider screening with a TSH test and also assessing for a personal or family history of thyroid disease. If the TSH level is within reference range, there generally is no need to monitor while treating with LDN. Consider checking TSH levels every 4 months in patients with thyroid disease while they are on LDN therapy and be sure to educate them about symptoms of hyperthyroidism.

Side Effects

Low-dose naltrexone has a minimal side-effect profile with self-limited side effects that often resolve within approximately 1 week. One of the most commonly reported side effects is sleep disturbance with vivid dreams, which has been reported in 37% of participants.1 If your patients experience this side effect, you can reassure them that it improves with time. You also can switch to morning dosing to try and alleviate sleep disturbances at night. Another possible side effect is gastrointestinal tract upset. Importantly, there is no known abuse potential for LDN.1 To stop LDN, patients should be stable for 6 to 12 months, and there is no need to wean them off it.

Cost and Availability

Because use of LDN in dermatology is considered off label and it is not approved by the US Food and Drug Administration to treat any medical conditions, it must be prescribed through a compounding pharmacy, usually without insurance coverage. The monthly cost is approximately $30 depending on the pharmacy (unpublished data), which may be cost prohibitive for patients, so it is important to counsel them about price before starting treatment.

Final Thoughts

Low-dose naltrexone is an alternative treatment option that can be considered in patients with inflammatory skin diseases. It has a favorable side-effect profile, especially compared to other systemic anti-inflammatory agents; however, additional studies are needed to learn more about its safety and efficacy. If patients ask you about LDN, the information provided here can guide you with how it works and how to prescribe it.

Low-dose naltrexone (LDN) has shown efficacy in off-label treatment of a variety of inflammatory diseases ranging from Crohn disease to multiple sclerosis.1 There are limited data about the use of LDN in dermatology, but reports regarding how it works as an anti-inflammatory agent have been published.1,2

Naltrexone is an opioid receptor antagonist that originally was approved by the US Food and Drug Administration to treat addiction to alcohol, opiates, and heroin.2 The dose of naltrexone to treat addiction ranges from 50 to 100 mg/d, and at these levels the effects of opioids are blocked for 24 hours; however, the dosing for LDN is much lower, ranging from 1.5 to 4.5 mg/d.3 At this low dose, naltrexone partially binds to various opioid receptors, leading to a temporary blockade.4 One of the downstream effects of this opioid receptor blockade is a paradoxical increase in endogenous endorphins.3

In addition to opioid blockage, lower doses of naltrexone have anti-inflammatory effects by inhibiting nonopioid receptors. Naltrexone blocks toll-like receptor 4, which is found on keratinocytes and also on macrophages such as microglia.5 These macrophages also contain inflammatory compounds such as tumor necrosis factor α and IL-6. Low-dose naltrexone can suppress levels of these inflammatory markers. It is important to note that these anti-inflammatory effects have not been observed at the standard higher doses of naltrexone.1

When to Use

Low-dose naltrexone is a treatment option for inflammatory dermatologic conditions. A recent review of the literature outlined the use of LDN in a variety of inflammatory skin conditions. Improvement was noted in patients with Hailey-Hailey disease, lichen planopilaris, and various types of pruritus (ie, aquagenic, cholestatic, uremic, atopic dermatitis related).3 A case report of LDN successfully treating a patient with psoriasis also has been published.6 We often use LDN at the University of Wisconsin (Madison, Wisconsin) to treat patients with psoriasis. Ekelem et al3 also discussed patients with skin conditions that either had no response or worsened with naltrexone treatment, including various types of pruritus (ie, uremic, mycosis fungoides related, other causes of pruritus). Importantly, in the majority of cases without an improved response, the dose used was 50 mg/d.3 Higher doses of naltrexone are not known to have anti-inflammatory effects.

Low-dose naltrexone can be considered as a treatment option in patients with contraindications to other systemic anti-inflammatory treatments; for example, patients with a history of malignancy may prefer to avoid treatment with biologic agents. Low-dose naltrexone also can be considered as a treatment option in patients who are uncomfortable with the side-effect profiles of other systemic anti-inflammatory treatments, such as the risk for leukemias and lymphomas associated with biologic agents, the risk for liver toxicity with methotrexate, or the risk for hyperlipidemia with acitretin.

 

 

How to Monitor

The following monitoring information is adapted from the practice of Apple Bodemer, MD, a board-certified dermatologist at the University of Wisconsin (Madison, Wisconsin) who also is fellowship trained in integrative medicine.

There is a paucity of published data about LDN dosing for inflammatory skin diseases. However, prescribers should be aware that LDN can alter thyroid hormone levels, especially in patients with autoimmune thyroid disease. If a thyroid-stimulating hormone (TSH) level within reference range has not been noted in the last year, consider screening with a TSH test and also assessing for a personal or family history of thyroid disease. If the TSH level is within reference range, there generally is no need to monitor while treating with LDN. Consider checking TSH levels every 4 months in patients with thyroid disease while they are on LDN therapy and be sure to educate them about symptoms of hyperthyroidism.

Side Effects

Low-dose naltrexone has a minimal side-effect profile with self-limited side effects that often resolve within approximately 1 week. One of the most commonly reported side effects is sleep disturbance with vivid dreams, which has been reported in 37% of participants.1 If your patients experience this side effect, you can reassure them that it improves with time. You also can switch to morning dosing to try and alleviate sleep disturbances at night. Another possible side effect is gastrointestinal tract upset. Importantly, there is no known abuse potential for LDN.1 To stop LDN, patients should be stable for 6 to 12 months, and there is no need to wean them off it.

Cost and Availability

Because use of LDN in dermatology is considered off label and it is not approved by the US Food and Drug Administration to treat any medical conditions, it must be prescribed through a compounding pharmacy, usually without insurance coverage. The monthly cost is approximately $30 depending on the pharmacy (unpublished data), which may be cost prohibitive for patients, so it is important to counsel them about price before starting treatment.

Final Thoughts

Low-dose naltrexone is an alternative treatment option that can be considered in patients with inflammatory skin diseases. It has a favorable side-effect profile, especially compared to other systemic anti-inflammatory agents; however, additional studies are needed to learn more about its safety and efficacy. If patients ask you about LDN, the information provided here can guide you with how it works and how to prescribe it.

References
  1. Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33:451-459.
  2. Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337.
  3. Ekelem C, Juhasz M, Khera P, et al. Utility of naltrexone treatment for chronic inflammatory dermatologic conditions: a systematic review. JAMA Dermatol. 2019;155:229-236.
  4. Bihari B. Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS. AIDS Patient Care. 1995;9:3.
  5. Lee B, Elston DM. The uses of naltrexone in dermatologic conditions [published online December 21, 2018]. J Am Acad Dermatol. 2019;80:1746-1752.
  6. Bridgman AC, Kirchhof MG. Treatment of psoriasis vulgaris using low-dose naltrexone. JAAD Case Rep. 2018;4:827-829.
References
  1. Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33:451-459.
  2. Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337.
  3. Ekelem C, Juhasz M, Khera P, et al. Utility of naltrexone treatment for chronic inflammatory dermatologic conditions: a systematic review. JAMA Dermatol. 2019;155:229-236.
  4. Bihari B. Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS. AIDS Patient Care. 1995;9:3.
  5. Lee B, Elston DM. The uses of naltrexone in dermatologic conditions [published online December 21, 2018]. J Am Acad Dermatol. 2019;80:1746-1752.
  6. Bridgman AC, Kirchhof MG. Treatment of psoriasis vulgaris using low-dose naltrexone. JAAD Case Rep. 2018;4:827-829.
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A Comparison of Knowledge Acquisition and Perceived Efficacy of a Traditional vs Flipped Classroom–Based Dermatology Residency Curriculum

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The ideal method of resident education is a subject of great interest within the medical community, and many dermatology residency programs utilize a traditional classroom model for didactic training consisting of required textbook reading completed at home and classroom lectures that often include presentations featuring text, dermatology images, and questions throughout the lecture. A second teaching model is known as the flipped, or inverted, classroom. This model moves the didactic material that typically is covered in the classroom into the realm of home study or homework and focuses on application and clarification of the new material in the classroom. 1 There is an emphasis on completing and understanding course material prior to the classroom session. Students are expected to be prepared for the lesson, and the classroom session can include question review and deeper exploration of the topic with a focus on subject mastery. 2

In recent years, the flipped classroom model has been used in elementary education, due in part to the influence of teachers Bergmann and Sams,3 as described in their book Flip Your Classroom: Reach Every Student in Every Class Every Day. More recently, Prober and Khan4 argued for its use in medical education, and this model has been utilized in medical school curricula to teach specialty subjects, including medical dermatology.5

Given the increasing popularity and use of the flipped classroom, the primary objective of this study was to determine if a difference in knowledge acquisition and resident perception exists between the traditional and flipped classrooms. If differences do exist, the secondary aim was to quantify them. We hypothesized that the flipped classroom actively engages residents and would improve both knowledge acquisition and resident sentiment toward the residency program curriculum compared to the traditional model.

Methods

The Duke Health (Durham, North Carolina) institutional review board granted approval for this study. All of the dermatology residents from Duke University Medical Center for the 2014-2015 academic year participated in this study. Twelve individual lectures chosen by the dermatology residency program director were included: 6 traditional lectures and 6 flipped lectures. The lectures were paired for similar content.

Survey Administration
Each resident was assigned a unique 4-digit numeric code that was unknown to the investigators and recorded at the beginning of each survey. The residents expected flipped lectures for each session and were blinded as to when a traditional lecture and quiz would occur, with the exception of the resident providing the lecture. Classroom presentations were immediately followed by a voluntary survey administered through Qualtrics.6 Consent was given at the beginning of each survey, followed by 10 factual questions and 10 perception questions. The factual questions varied based on the lecture topic and were multiple-choice questions written by the program director, associate program director, and faculty. Each factual question was worth 10 points, and the scaled score for each quiz had a maximum value of 100. The perception questions were developed by the authors (J.H. and A.R.A.) in consultation with a survey methodology expert at the Duke Social Science Research Institute. These questions remained constant across each survey and were descriptive based on standard response scales. The data were extracted from Qualtrics for statistical analysis.

Statistical Analysis
The mean score with the standard deviation for each factual question quiz was calculated and plotted. A generalized linear mixed model was created to study the difference in quiz scores between the 2 classroom models after adjusting for other covariates, including resident, the interaction between resident and class type, quiz time, and the interaction between class type and quiz time. The variable resident was specified as a random variable, and a variance components covariance structure was used. For the perception questions, the frequency and percentage of each answer for a question was counted. Generalized linear mixed models with a Poisson distribution were created to study the difference in answers for each survey question between the 2 curriculum types after adjusting for other covariates, including scores for factual questions, quiz time, and the interaction between class type and quiz time. The variable resident was again specified as a random variable, and a diagonal covariance structure was used. All statistical analyses were carried out using SAS software package version 9.4 (SAS Institute) by the Duke University Department of Biostatistics and Bioinformatics. P<.05 was considered statistically significant.

Results

All 9 of the department’s residents were included and participated in this study. Mean score with standard deviation for each factual quiz is plotted in the Figure. Across all residents, the mean factual quiz score was slightly higher but not statistically significant in the flipped vs traditional classrooms (67.5% vs 65.4%; P=.448)(data not shown). When comparing traditional and flipped factual quiz scores by individual resident, there was not a significant difference in quiz performance (P=.166)(data not shown). However, there was a significant difference in the factual quiz scores among residents for all quizzes (P=.005) as well as a significant difference in performance between each individual quiz over time (P<.001)(data not shown). In the traditional classroom, residents demonstrated a trend in variable performance with each factual quiz. In the flipped classroom, residents also had variable performance, with wide-ranging scores (P=.008)(data not shown).

 

 

Each resident also answered 10 perception questions (Table 1). When comparing the responses by quiz type (Table 2), there was a significant difference for several questions in favor of the flipped classroom: how actively residents thought their co-residents participated in the lecture (P<.001), how much each resident enjoyed the session (P=.038), and how much each resident believed their co-residents enjoyed the session (P=.026). Additionally, residents thought that the flipped classroom sessions were more efficient (P=.033), better prepared them for boards (P=.050), and better prepared them for clinical practice (P=.034). There was not a significant difference in the amount of reading and preparation residents did for class (P=.697), how actively the residents thought they participated in the lecture (P=.303), the effectiveness of the day’s curriculum structure (P=.178), or whether residents thought the lesson increased their knowledge on the topic (P=.084).

Comment

The traditional model in medical education has undergone changes in recent years, and researchers have been looking for new ways to convey more information in shorter periods of time, especially as the field of medicine continues to expand. Despite the growing popularity and adoption of the flipped classroom, studies in dermatology have been limited. In this study, we compared a traditional classroom model with the flipped model, assessing both knowledge acquisition and resident perception of the experience.

There was not a significant difference in mean objective quiz scores when comparing the 2 curricula. The flipped model was not better or worse than the traditional teaching model at relaying information and promoting learning. Rather, there was a significant difference in quiz scores based on the individual resident and on the individual quiz. Individual performance was not affected by the teaching model but rather by the individual resident and lecture topic.

These findings differ from a study of internal medicine residents, which revealed that trainees in a quality-improvement flipped classroom had greater increases in knowledge than a traditional cohort.7 It is difficult to make direct comparisons to this group, given the difference in specialty and subject content. In comparison, an emergency medicine program completed a cross-sectional cohort study of in-service examination scores in the setting of a traditional curriculum (2011-2012) vs a flipped curriculum (2015-2016) and found that there was no statistical difference in average in-service examination scores.8 The type of examination content in this study may be more similar to the quizzes that our residents experienced (ie, fact-based material based on traditional medical knowledge).

The dermatology residents favored the flipped curriculum for 6 of 10 perception questions, which included areas of co-resident participation, personal and co-resident enjoyment, efficiency, boards preparation, and preparation for clinical practice. They did not favor the flipped classroom for prelecture preparation, personal participation, lecture effectiveness, or knowledge acquisition. They perceived their peers as being more engaged and found the flipped classroom to be a more positive experience. The residents thought that the flipped lectures were more time efficient, which could have contributed to overall learner satisfaction. Additionally, they thought that the flipped model better prepared them for both the boards and clinical practice, which are markers of future performance.

These findings are consistent with other studies that revealed improved postcourse perception scores for a quality improvement emergency medicine–flipped classroom. Most of this group preferred the flipped classroom over the traditional after completion of the flipped curriculum.9 A neurosurgery residency program also reported increased resident engagement and resident preference for a newly designed flipped curriculum.10



Overall, our data indicate that there was no objective change in knowledge acquisition at the time of the quiz, but learner satisfaction was significantly greater in the flipped classroom model.

Limitations
This study was comprised of a small number of residents from a single institution and was based on a limited number of lectures given throughout the year. All lectures during the study year were flipped with the exception of the 6 traditional study lectures. Therefore, each resident who presented a traditional lecture was not blinded for her individual assigned lecture. In addition, because traditional lectures only occurred on study days, once the lectures started, all trainees could predict that a content quiz would occur at the end of the session, which could potentially introduce bias toward better quiz performance for the traditional lectures.

Conclusion

When comparing traditional and flipped classroom models, we found no difference in knowledge acquisition. Rather, the difference in quiz scores was among individual residents. There was a significant positive difference in how residents perceived these teaching models, including enjoyment and feeling prepared for the boards. The flipped classroom model provides another opportunity to better engage residents during teaching and should be considered as part of dermatology residency education.



Acknowledgments
Duke Social Sciences Institute postdoctoral fellow Scott Clifford, PhD, and Duke Dermatology residents Daniel Chang, MD; Sinae Kane, MD; Rebecca Bialas, MD; Jolene Jewell, MD; Elizabeth Ju, MD; Michael Raisch, MD; Reed Garza, MD; Joanna Hooten, MD; and E. Schell Bressler, MD (all Durham, North Carolina).

References
  1. Lage MJ, Platt GJ, Treglia M. Inverting the classroom: a gateway to creating an inclusive learning environment. J Economic Educ. 2000;31:30-43.
  2. Gillispie V. Using the flipped classroom to bridge the gap to generation Y. Ochsner J. 2016;16:32-36.
  3. Bergmann J, Sams A. Flip Your Classroom: Reach Every Student in Every Class Every Day. Alexandria, VA: International Society for Technology in Education; 2012.
  4. Prober CG, Khan S. Medical education reimagined: a call to action. Acad Med. 2013;88:1407-1410.
  5. Aughenbaugh WD. Dermatology flipped, blended and shaken: a comparison of the effect of an active learning modality on student learning, satisfaction, and teaching. Paper presented at: Dermatology Teachers Exchange Group 2013; September 27, 2013; Chicago, IL.
  6. Oppenheimer AJ, Pannucci CJ, Kasten SJ, et al. Survey says? A primer on web-based survey design and distribution. Plast Reconstr Surg. 2011;128:299-304.
  7. Bonnes SL, Ratelle JT, Halvorsen AJ, et al. Flipping the quality improvement classroom in residency education. Acad Med. 2017;92:101-107.
  8. King AM, Mayer C, Barrie M, et al. Replacing lectures with small groups: the impact of flipping the residency conference day. West J Emerg Med. 2018;19:11-17.
  9. Young TP, Bailey CJ, Guptill M, et al. The flipped classroom: a modality for mixed asynchronous and synchronous learning in a residency program. Western J Emerg Med. 2014;15:938-944.
  10. Girgis F, Miller JP. Implementation of a “flipped classroom” for neurosurgery resident education. Can J Neurol Sci. 2018;45:76-82.
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The authors report no conflict of interest.

Correspondence: Amber Reck Atwater, MD, Duke University Hospital, Department of Dermatology, 5324 McFarland Rd #210, Durham, NC 27707 ([email protected]).

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The ideal method of resident education is a subject of great interest within the medical community, and many dermatology residency programs utilize a traditional classroom model for didactic training consisting of required textbook reading completed at home and classroom lectures that often include presentations featuring text, dermatology images, and questions throughout the lecture. A second teaching model is known as the flipped, or inverted, classroom. This model moves the didactic material that typically is covered in the classroom into the realm of home study or homework and focuses on application and clarification of the new material in the classroom. 1 There is an emphasis on completing and understanding course material prior to the classroom session. Students are expected to be prepared for the lesson, and the classroom session can include question review and deeper exploration of the topic with a focus on subject mastery. 2

In recent years, the flipped classroom model has been used in elementary education, due in part to the influence of teachers Bergmann and Sams,3 as described in their book Flip Your Classroom: Reach Every Student in Every Class Every Day. More recently, Prober and Khan4 argued for its use in medical education, and this model has been utilized in medical school curricula to teach specialty subjects, including medical dermatology.5

Given the increasing popularity and use of the flipped classroom, the primary objective of this study was to determine if a difference in knowledge acquisition and resident perception exists between the traditional and flipped classrooms. If differences do exist, the secondary aim was to quantify them. We hypothesized that the flipped classroom actively engages residents and would improve both knowledge acquisition and resident sentiment toward the residency program curriculum compared to the traditional model.

Methods

The Duke Health (Durham, North Carolina) institutional review board granted approval for this study. All of the dermatology residents from Duke University Medical Center for the 2014-2015 academic year participated in this study. Twelve individual lectures chosen by the dermatology residency program director were included: 6 traditional lectures and 6 flipped lectures. The lectures were paired for similar content.

Survey Administration
Each resident was assigned a unique 4-digit numeric code that was unknown to the investigators and recorded at the beginning of each survey. The residents expected flipped lectures for each session and were blinded as to when a traditional lecture and quiz would occur, with the exception of the resident providing the lecture. Classroom presentations were immediately followed by a voluntary survey administered through Qualtrics.6 Consent was given at the beginning of each survey, followed by 10 factual questions and 10 perception questions. The factual questions varied based on the lecture topic and were multiple-choice questions written by the program director, associate program director, and faculty. Each factual question was worth 10 points, and the scaled score for each quiz had a maximum value of 100. The perception questions were developed by the authors (J.H. and A.R.A.) in consultation with a survey methodology expert at the Duke Social Science Research Institute. These questions remained constant across each survey and were descriptive based on standard response scales. The data were extracted from Qualtrics for statistical analysis.

Statistical Analysis
The mean score with the standard deviation for each factual question quiz was calculated and plotted. A generalized linear mixed model was created to study the difference in quiz scores between the 2 classroom models after adjusting for other covariates, including resident, the interaction between resident and class type, quiz time, and the interaction between class type and quiz time. The variable resident was specified as a random variable, and a variance components covariance structure was used. For the perception questions, the frequency and percentage of each answer for a question was counted. Generalized linear mixed models with a Poisson distribution were created to study the difference in answers for each survey question between the 2 curriculum types after adjusting for other covariates, including scores for factual questions, quiz time, and the interaction between class type and quiz time. The variable resident was again specified as a random variable, and a diagonal covariance structure was used. All statistical analyses were carried out using SAS software package version 9.4 (SAS Institute) by the Duke University Department of Biostatistics and Bioinformatics. P<.05 was considered statistically significant.

Results

All 9 of the department’s residents were included and participated in this study. Mean score with standard deviation for each factual quiz is plotted in the Figure. Across all residents, the mean factual quiz score was slightly higher but not statistically significant in the flipped vs traditional classrooms (67.5% vs 65.4%; P=.448)(data not shown). When comparing traditional and flipped factual quiz scores by individual resident, there was not a significant difference in quiz performance (P=.166)(data not shown). However, there was a significant difference in the factual quiz scores among residents for all quizzes (P=.005) as well as a significant difference in performance between each individual quiz over time (P<.001)(data not shown). In the traditional classroom, residents demonstrated a trend in variable performance with each factual quiz. In the flipped classroom, residents also had variable performance, with wide-ranging scores (P=.008)(data not shown).

 

 

Each resident also answered 10 perception questions (Table 1). When comparing the responses by quiz type (Table 2), there was a significant difference for several questions in favor of the flipped classroom: how actively residents thought their co-residents participated in the lecture (P<.001), how much each resident enjoyed the session (P=.038), and how much each resident believed their co-residents enjoyed the session (P=.026). Additionally, residents thought that the flipped classroom sessions were more efficient (P=.033), better prepared them for boards (P=.050), and better prepared them for clinical practice (P=.034). There was not a significant difference in the amount of reading and preparation residents did for class (P=.697), how actively the residents thought they participated in the lecture (P=.303), the effectiveness of the day’s curriculum structure (P=.178), or whether residents thought the lesson increased their knowledge on the topic (P=.084).

Comment

The traditional model in medical education has undergone changes in recent years, and researchers have been looking for new ways to convey more information in shorter periods of time, especially as the field of medicine continues to expand. Despite the growing popularity and adoption of the flipped classroom, studies in dermatology have been limited. In this study, we compared a traditional classroom model with the flipped model, assessing both knowledge acquisition and resident perception of the experience.

There was not a significant difference in mean objective quiz scores when comparing the 2 curricula. The flipped model was not better or worse than the traditional teaching model at relaying information and promoting learning. Rather, there was a significant difference in quiz scores based on the individual resident and on the individual quiz. Individual performance was not affected by the teaching model but rather by the individual resident and lecture topic.

These findings differ from a study of internal medicine residents, which revealed that trainees in a quality-improvement flipped classroom had greater increases in knowledge than a traditional cohort.7 It is difficult to make direct comparisons to this group, given the difference in specialty and subject content. In comparison, an emergency medicine program completed a cross-sectional cohort study of in-service examination scores in the setting of a traditional curriculum (2011-2012) vs a flipped curriculum (2015-2016) and found that there was no statistical difference in average in-service examination scores.8 The type of examination content in this study may be more similar to the quizzes that our residents experienced (ie, fact-based material based on traditional medical knowledge).

The dermatology residents favored the flipped curriculum for 6 of 10 perception questions, which included areas of co-resident participation, personal and co-resident enjoyment, efficiency, boards preparation, and preparation for clinical practice. They did not favor the flipped classroom for prelecture preparation, personal participation, lecture effectiveness, or knowledge acquisition. They perceived their peers as being more engaged and found the flipped classroom to be a more positive experience. The residents thought that the flipped lectures were more time efficient, which could have contributed to overall learner satisfaction. Additionally, they thought that the flipped model better prepared them for both the boards and clinical practice, which are markers of future performance.

These findings are consistent with other studies that revealed improved postcourse perception scores for a quality improvement emergency medicine–flipped classroom. Most of this group preferred the flipped classroom over the traditional after completion of the flipped curriculum.9 A neurosurgery residency program also reported increased resident engagement and resident preference for a newly designed flipped curriculum.10



Overall, our data indicate that there was no objective change in knowledge acquisition at the time of the quiz, but learner satisfaction was significantly greater in the flipped classroom model.

Limitations
This study was comprised of a small number of residents from a single institution and was based on a limited number of lectures given throughout the year. All lectures during the study year were flipped with the exception of the 6 traditional study lectures. Therefore, each resident who presented a traditional lecture was not blinded for her individual assigned lecture. In addition, because traditional lectures only occurred on study days, once the lectures started, all trainees could predict that a content quiz would occur at the end of the session, which could potentially introduce bias toward better quiz performance for the traditional lectures.

Conclusion

When comparing traditional and flipped classroom models, we found no difference in knowledge acquisition. Rather, the difference in quiz scores was among individual residents. There was a significant positive difference in how residents perceived these teaching models, including enjoyment and feeling prepared for the boards. The flipped classroom model provides another opportunity to better engage residents during teaching and should be considered as part of dermatology residency education.



Acknowledgments
Duke Social Sciences Institute postdoctoral fellow Scott Clifford, PhD, and Duke Dermatology residents Daniel Chang, MD; Sinae Kane, MD; Rebecca Bialas, MD; Jolene Jewell, MD; Elizabeth Ju, MD; Michael Raisch, MD; Reed Garza, MD; Joanna Hooten, MD; and E. Schell Bressler, MD (all Durham, North Carolina).

The ideal method of resident education is a subject of great interest within the medical community, and many dermatology residency programs utilize a traditional classroom model for didactic training consisting of required textbook reading completed at home and classroom lectures that often include presentations featuring text, dermatology images, and questions throughout the lecture. A second teaching model is known as the flipped, or inverted, classroom. This model moves the didactic material that typically is covered in the classroom into the realm of home study or homework and focuses on application and clarification of the new material in the classroom. 1 There is an emphasis on completing and understanding course material prior to the classroom session. Students are expected to be prepared for the lesson, and the classroom session can include question review and deeper exploration of the topic with a focus on subject mastery. 2

In recent years, the flipped classroom model has been used in elementary education, due in part to the influence of teachers Bergmann and Sams,3 as described in their book Flip Your Classroom: Reach Every Student in Every Class Every Day. More recently, Prober and Khan4 argued for its use in medical education, and this model has been utilized in medical school curricula to teach specialty subjects, including medical dermatology.5

Given the increasing popularity and use of the flipped classroom, the primary objective of this study was to determine if a difference in knowledge acquisition and resident perception exists between the traditional and flipped classrooms. If differences do exist, the secondary aim was to quantify them. We hypothesized that the flipped classroom actively engages residents and would improve both knowledge acquisition and resident sentiment toward the residency program curriculum compared to the traditional model.

Methods

The Duke Health (Durham, North Carolina) institutional review board granted approval for this study. All of the dermatology residents from Duke University Medical Center for the 2014-2015 academic year participated in this study. Twelve individual lectures chosen by the dermatology residency program director were included: 6 traditional lectures and 6 flipped lectures. The lectures were paired for similar content.

Survey Administration
Each resident was assigned a unique 4-digit numeric code that was unknown to the investigators and recorded at the beginning of each survey. The residents expected flipped lectures for each session and were blinded as to when a traditional lecture and quiz would occur, with the exception of the resident providing the lecture. Classroom presentations were immediately followed by a voluntary survey administered through Qualtrics.6 Consent was given at the beginning of each survey, followed by 10 factual questions and 10 perception questions. The factual questions varied based on the lecture topic and were multiple-choice questions written by the program director, associate program director, and faculty. Each factual question was worth 10 points, and the scaled score for each quiz had a maximum value of 100. The perception questions were developed by the authors (J.H. and A.R.A.) in consultation with a survey methodology expert at the Duke Social Science Research Institute. These questions remained constant across each survey and were descriptive based on standard response scales. The data were extracted from Qualtrics for statistical analysis.

Statistical Analysis
The mean score with the standard deviation for each factual question quiz was calculated and plotted. A generalized linear mixed model was created to study the difference in quiz scores between the 2 classroom models after adjusting for other covariates, including resident, the interaction between resident and class type, quiz time, and the interaction between class type and quiz time. The variable resident was specified as a random variable, and a variance components covariance structure was used. For the perception questions, the frequency and percentage of each answer for a question was counted. Generalized linear mixed models with a Poisson distribution were created to study the difference in answers for each survey question between the 2 curriculum types after adjusting for other covariates, including scores for factual questions, quiz time, and the interaction between class type and quiz time. The variable resident was again specified as a random variable, and a diagonal covariance structure was used. All statistical analyses were carried out using SAS software package version 9.4 (SAS Institute) by the Duke University Department of Biostatistics and Bioinformatics. P<.05 was considered statistically significant.

Results

All 9 of the department’s residents were included and participated in this study. Mean score with standard deviation for each factual quiz is plotted in the Figure. Across all residents, the mean factual quiz score was slightly higher but not statistically significant in the flipped vs traditional classrooms (67.5% vs 65.4%; P=.448)(data not shown). When comparing traditional and flipped factual quiz scores by individual resident, there was not a significant difference in quiz performance (P=.166)(data not shown). However, there was a significant difference in the factual quiz scores among residents for all quizzes (P=.005) as well as a significant difference in performance between each individual quiz over time (P<.001)(data not shown). In the traditional classroom, residents demonstrated a trend in variable performance with each factual quiz. In the flipped classroom, residents also had variable performance, with wide-ranging scores (P=.008)(data not shown).

 

 

Each resident also answered 10 perception questions (Table 1). When comparing the responses by quiz type (Table 2), there was a significant difference for several questions in favor of the flipped classroom: how actively residents thought their co-residents participated in the lecture (P<.001), how much each resident enjoyed the session (P=.038), and how much each resident believed their co-residents enjoyed the session (P=.026). Additionally, residents thought that the flipped classroom sessions were more efficient (P=.033), better prepared them for boards (P=.050), and better prepared them for clinical practice (P=.034). There was not a significant difference in the amount of reading and preparation residents did for class (P=.697), how actively the residents thought they participated in the lecture (P=.303), the effectiveness of the day’s curriculum structure (P=.178), or whether residents thought the lesson increased their knowledge on the topic (P=.084).

Comment

The traditional model in medical education has undergone changes in recent years, and researchers have been looking for new ways to convey more information in shorter periods of time, especially as the field of medicine continues to expand. Despite the growing popularity and adoption of the flipped classroom, studies in dermatology have been limited. In this study, we compared a traditional classroom model with the flipped model, assessing both knowledge acquisition and resident perception of the experience.

There was not a significant difference in mean objective quiz scores when comparing the 2 curricula. The flipped model was not better or worse than the traditional teaching model at relaying information and promoting learning. Rather, there was a significant difference in quiz scores based on the individual resident and on the individual quiz. Individual performance was not affected by the teaching model but rather by the individual resident and lecture topic.

These findings differ from a study of internal medicine residents, which revealed that trainees in a quality-improvement flipped classroom had greater increases in knowledge than a traditional cohort.7 It is difficult to make direct comparisons to this group, given the difference in specialty and subject content. In comparison, an emergency medicine program completed a cross-sectional cohort study of in-service examination scores in the setting of a traditional curriculum (2011-2012) vs a flipped curriculum (2015-2016) and found that there was no statistical difference in average in-service examination scores.8 The type of examination content in this study may be more similar to the quizzes that our residents experienced (ie, fact-based material based on traditional medical knowledge).

The dermatology residents favored the flipped curriculum for 6 of 10 perception questions, which included areas of co-resident participation, personal and co-resident enjoyment, efficiency, boards preparation, and preparation for clinical practice. They did not favor the flipped classroom for prelecture preparation, personal participation, lecture effectiveness, or knowledge acquisition. They perceived their peers as being more engaged and found the flipped classroom to be a more positive experience. The residents thought that the flipped lectures were more time efficient, which could have contributed to overall learner satisfaction. Additionally, they thought that the flipped model better prepared them for both the boards and clinical practice, which are markers of future performance.

These findings are consistent with other studies that revealed improved postcourse perception scores for a quality improvement emergency medicine–flipped classroom. Most of this group preferred the flipped classroom over the traditional after completion of the flipped curriculum.9 A neurosurgery residency program also reported increased resident engagement and resident preference for a newly designed flipped curriculum.10



Overall, our data indicate that there was no objective change in knowledge acquisition at the time of the quiz, but learner satisfaction was significantly greater in the flipped classroom model.

Limitations
This study was comprised of a small number of residents from a single institution and was based on a limited number of lectures given throughout the year. All lectures during the study year were flipped with the exception of the 6 traditional study lectures. Therefore, each resident who presented a traditional lecture was not blinded for her individual assigned lecture. In addition, because traditional lectures only occurred on study days, once the lectures started, all trainees could predict that a content quiz would occur at the end of the session, which could potentially introduce bias toward better quiz performance for the traditional lectures.

Conclusion

When comparing traditional and flipped classroom models, we found no difference in knowledge acquisition. Rather, the difference in quiz scores was among individual residents. There was a significant positive difference in how residents perceived these teaching models, including enjoyment and feeling prepared for the boards. The flipped classroom model provides another opportunity to better engage residents during teaching and should be considered as part of dermatology residency education.



Acknowledgments
Duke Social Sciences Institute postdoctoral fellow Scott Clifford, PhD, and Duke Dermatology residents Daniel Chang, MD; Sinae Kane, MD; Rebecca Bialas, MD; Jolene Jewell, MD; Elizabeth Ju, MD; Michael Raisch, MD; Reed Garza, MD; Joanna Hooten, MD; and E. Schell Bressler, MD (all Durham, North Carolina).

References
  1. Lage MJ, Platt GJ, Treglia M. Inverting the classroom: a gateway to creating an inclusive learning environment. J Economic Educ. 2000;31:30-43.
  2. Gillispie V. Using the flipped classroom to bridge the gap to generation Y. Ochsner J. 2016;16:32-36.
  3. Bergmann J, Sams A. Flip Your Classroom: Reach Every Student in Every Class Every Day. Alexandria, VA: International Society for Technology in Education; 2012.
  4. Prober CG, Khan S. Medical education reimagined: a call to action. Acad Med. 2013;88:1407-1410.
  5. Aughenbaugh WD. Dermatology flipped, blended and shaken: a comparison of the effect of an active learning modality on student learning, satisfaction, and teaching. Paper presented at: Dermatology Teachers Exchange Group 2013; September 27, 2013; Chicago, IL.
  6. Oppenheimer AJ, Pannucci CJ, Kasten SJ, et al. Survey says? A primer on web-based survey design and distribution. Plast Reconstr Surg. 2011;128:299-304.
  7. Bonnes SL, Ratelle JT, Halvorsen AJ, et al. Flipping the quality improvement classroom in residency education. Acad Med. 2017;92:101-107.
  8. King AM, Mayer C, Barrie M, et al. Replacing lectures with small groups: the impact of flipping the residency conference day. West J Emerg Med. 2018;19:11-17.
  9. Young TP, Bailey CJ, Guptill M, et al. The flipped classroom: a modality for mixed asynchronous and synchronous learning in a residency program. Western J Emerg Med. 2014;15:938-944.
  10. Girgis F, Miller JP. Implementation of a “flipped classroom” for neurosurgery resident education. Can J Neurol Sci. 2018;45:76-82.
References
  1. Lage MJ, Platt GJ, Treglia M. Inverting the classroom: a gateway to creating an inclusive learning environment. J Economic Educ. 2000;31:30-43.
  2. Gillispie V. Using the flipped classroom to bridge the gap to generation Y. Ochsner J. 2016;16:32-36.
  3. Bergmann J, Sams A. Flip Your Classroom: Reach Every Student in Every Class Every Day. Alexandria, VA: International Society for Technology in Education; 2012.
  4. Prober CG, Khan S. Medical education reimagined: a call to action. Acad Med. 2013;88:1407-1410.
  5. Aughenbaugh WD. Dermatology flipped, blended and shaken: a comparison of the effect of an active learning modality on student learning, satisfaction, and teaching. Paper presented at: Dermatology Teachers Exchange Group 2013; September 27, 2013; Chicago, IL.
  6. Oppenheimer AJ, Pannucci CJ, Kasten SJ, et al. Survey says? A primer on web-based survey design and distribution. Plast Reconstr Surg. 2011;128:299-304.
  7. Bonnes SL, Ratelle JT, Halvorsen AJ, et al. Flipping the quality improvement classroom in residency education. Acad Med. 2017;92:101-107.
  8. King AM, Mayer C, Barrie M, et al. Replacing lectures with small groups: the impact of flipping the residency conference day. West J Emerg Med. 2018;19:11-17.
  9. Young TP, Bailey CJ, Guptill M, et al. The flipped classroom: a modality for mixed asynchronous and synchronous learning in a residency program. Western J Emerg Med. 2014;15:938-944.
  10. Girgis F, Miller JP. Implementation of a “flipped classroom” for neurosurgery resident education. Can J Neurol Sci. 2018;45:76-82.
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  • There was not a significant difference in dermatology resident factual quiz scores when comparing flipped vs traditional classroom teaching sessions.
  • There was a significant difference between the flipped vs traditional teaching models, with dermatology residents favoring the flipped classroom, for co-resident lecture participation and individual and co-resident enjoyment of the lecture.
  • Residents also perceived that the flipped classroom sessions were more efficient, better prepared them for boards, and better prepared them for clinical practice.
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Annual Skin Check: Examining the Dermatology Headlines of 2019

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Annual Skin Check: Examining the Dermatology Headlines of 2019

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.1 On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.2 In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.1 Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.3 In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.2 Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.4

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).5 Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”7 Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.6

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.8

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.8 In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.11 In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.8

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.12 The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).13

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.16 The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,14,17 and minocycline foam is the first topical tetracycline.15

 

 

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.18 The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).19

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.20 A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).21

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.24 In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.26 After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.27 The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.28

References
  1. Zraick K. Key West bans sunscreen containing chemicals believed to harm coral reefs. New York Times. February 7, 2019. https://www.nytimes.com/2019/02/07/us/sunscreen-coral-reef-key-west.html. Accessed December 23, 2019.
  2. Gies H. The U.S. Virigin Islands becomes the first American jurisdiction to ban common chemical sunscreens. Pacific Standard. July 18, 2019. https://psmag.com/environment/sunscreen-is-corals-biggest-anemone. Accessed December 23, 2019.
  3. Luscombe R. Republicans seek to overturn Key West ban on coral-damaging sunscreens. The Guardian. November 9, 2019. https://www.theguardian.com/us-news/2019/nov/09/key-west-sunscreen-coral-reef-backlash-skin-cancer. Accessed December 23, 2019.
  4. Salazar D. CVS to remove 2 chemicals from 60 store-brand sunscreens. Drug Store News. August 2, 2019. https://drugstorenews.com/retail-news/cvs-to-remove-2-chemicals-from-60-store-brand-sunscreens. Accessed December 23, 2019.
  5. Sunscreen drug products for over-the-counter human use. Fed Registr. 2019;84(38):6204-6275. To be codified at 21 CFR §201, 310, 347, and 352.
  6. DeLeo VA. Sunscreen regulations and advice for your patients. Cutis. 2019;103:251-253.
  7. Matta MK, Zusterzeel R, Pilli NR, et al. Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA. 2019;321:2082-2091.
  8. Mayor de Blasio, health officials declare end of measles outbreak in New York City [news release]. New York, NY: City of New York; September 3, 2019. https://www1.nyc.gov/office-of-the-mayor/news/409-19/mayor-de-blasio-health-officials-declare-end-measles-outbreak-new-york-city. Accessed December 23, 2019.
  9. Health department reports eleven new cases of measles in Brooklyn’s Orthodox Jewish community, urges on time vaccination for all children, especially before traveling to Israel and other countries experiencing measles outbreaks [news release]. New York, NY: City of New York; November 2, 2018. https://www1.nyc.gov/site/doh/about/press/pr2018/pr091-18.page. Accessed December 23, 2019.
  10. Centers for Disease Control and Prevention. Measles elimination. https://www.cdc.gov/measles/elimination.html. Updated October 4, 2019. Accessed December 23, 2019.
  11. McKinley J. Measles outbreak: N.Y. eliminates religious exemptions for vaccinations. New York Times. June 13, 2019. https://www.nytimes.com/2019/06/13/nyregion/measles-vaccinations-new-york.html. Accessed December 23, 2019.
  12. FDA approves Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents [news release]. Cambridge, MA: Sanofi; March 11, 2019. http://www.news.sanofi.us/2019-03-11-FDA-approves-Dupixent-R-dupilumab-for-moderate-to-severe-atopic-dermatitis-in-adolescents. Accessed December 23, 2019.
  13. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial [published online ahead of print November 6, 2019]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.3336.
  14. Galderma receives FDA approval for AKLIEF® (trifarotene) cream, 0.005%, the first new retinoid molecule for the treatment of acne in over 20 years [news release]. Fort Worth, TX: Galderma Laboratories, LP; October 4, 2019. https://www.multivu.com/players/English/8613051-galderma-aklief-retinoid-molecule-acne-treatment/. Accessed December 23, 2019.
  15. Update—Foamix receives FDA approval of AMZEEQ™ topical minocycline treatment for millions of moderate to severe acne sufferers [news release]. Bridgewater, NJ: Foamix Pharmaceuticals Ltd; October 18, 2019. http://www.foamix.com/news-releases/news-release-details/update-foamix-receives-fda-approval-amzeeqtm-topical-minocycline. Accessed December 23, 2019.
  16. Redfearn S. Clinical trial patient inclusion and exclusion criteria need an overhaul, say experts. CenterWatch website. April 23, 2018. https://www.centerwatch.com/cwweekly/2018/04/23/clinical-trial-patient-inclusion-and-exclusion-criteria-need-an-overhaul-say-experts. Accessed December 23, 2019.
  17. Tan J, Thiboutot D, Popp G, et al. Randomized phase 3 evaluation of trifarotene 50 mug/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80:1691-1699.
  18. FDA approves OTEZLA® (apremilast) for the treatment of oral ulcers associated with Behçet’s disease [news release]. Summit, NJ: Celgene; July 19, 2019. https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-OTEZLA-apremilast-for-the-Treatment-of-Oral-Ulcers-Associated-with-Behets-Disease/default.aspx. Accessed December 23, 2019.
  19. Apremilast [package insert]. Summit, NJ: Celgene Corporation; 2019.
  20. FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder [news release]. Silver Spring, MD: US Food and Drug Administration; October 8, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder. Accessed December 23, 2019.
  21. Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med. 2015;373:48-59.
  22. Light Therapy Mask recall statement. Neutrogena website. https://www.neutrogena.com/light-therapy-statement.html. Accessed December 23, 2019.
  23. Bromwich JE. Neutrogena recalls Light Therapy Masks, citing risk of eye injury. New York Times. July 18, 2019. https://www.nytimes.com/2019/07/18/style/neutrogena-light-therapy-mask-recall.html. Accessed December 23, 2019, 2019.
  24. Nguyen T. Neutrogena recalls acne mask over concerns about blue light. Chemical & Engineering News. August 6, 2019. https://cen.acs.org/safety/lab-safety/Neutrogena-recalls-acne-mask-over-concerns-about-blue-light/97/web/2019/08. Accessed November 16, 2019.
  25. Australian Government Department of Health, Therapeutic Goods Administration. Neutrogena Visibly Clear Light Therapy Acne Mask and Activator: Recall - potential for eye damage. https://www.tga.gov.au/alert/neutrogena-visibly-clear-light-therapy-acne-mask-and-activator. Published July 17, 2019. Accessed December 23, 2019.
  26. Johnson & Johnson Consumer Inc. to voluntarily recall a single lot of Johnson’s Baby Powder in the United States [press release]. New Brunswick, NJ: Johnson & Johnson Consumer Inc; October 18, 2019. https://www.factsabouttalc.com/_document/15-new-tests-from-the-same-bottle-of-johnsons-baby-powder-previously-tested-by-fda-find-no-asbestos?id=0000016e-1915-dc68-af7e-df3f147c0000. Accessed December 23, 2019.
  27. 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by FDA find no asbestos [press release]. New Brunswick, NJ: Johnson & Johnson Consumer Inc; October 29, 2019. https://www.factsabouttalc.com/_document/johnson-johnson-consumer-inc-to-voluntarily-recall-a-single-lot-of-johnsons-baby-powder-in-the-united-states?id=0000016d-debf-d71d-a77d-dfbfebeb0000. Accessed December 23, 2019.
  28. Hsu T. Johnson & Johnson says recalled baby powder doesn’t have asbestos. New York Times. October 29, 2019. https://www.nytimes.com/2019/10/29/business/johnson-baby-powder-asbestos.html. Accessed December 23, 2019.
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From the Department of Dermatology, State University of New York Downstate Health Sciences University, Brooklyn.

The author reports no conflict of interest.

Correspondence: Daniel R. Mazori, MD, Department of Dermatology, State University of New York Downstate Health Sciences University, 450 Clarkson Ave, Box 46, Brooklyn, NY 11203 ([email protected]).

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Correspondence: Daniel R. Mazori, MD, Department of Dermatology, State University of New York Downstate Health Sciences University, 450 Clarkson Ave, Box 46, Brooklyn, NY 11203 ([email protected]).

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From the Department of Dermatology, State University of New York Downstate Health Sciences University, Brooklyn.

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Correspondence: Daniel R. Mazori, MD, Department of Dermatology, State University of New York Downstate Health Sciences University, 450 Clarkson Ave, Box 46, Brooklyn, NY 11203 ([email protected]).

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From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.1 On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.2 In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.1 Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.3 In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.2 Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.4

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).5 Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”7 Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.6

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.8

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.8 In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.11 In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.8

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.12 The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).13

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.16 The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,14,17 and minocycline foam is the first topical tetracycline.15

 

 

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.18 The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).19

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.20 A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).21

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.24 In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.26 After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.27 The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.28

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.1 On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.2 In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.1 Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.3 In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.2 Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.4

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).5 Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”7 Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.6

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.8

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.8 In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.11 In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.8

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.12 The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).13

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.16 The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,14,17 and minocycline foam is the first topical tetracycline.15

 

 

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.18 The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).19

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.20 A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).21

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.24 In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.26 After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.27 The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.28

References
  1. Zraick K. Key West bans sunscreen containing chemicals believed to harm coral reefs. New York Times. February 7, 2019. https://www.nytimes.com/2019/02/07/us/sunscreen-coral-reef-key-west.html. Accessed December 23, 2019.
  2. Gies H. The U.S. Virigin Islands becomes the first American jurisdiction to ban common chemical sunscreens. Pacific Standard. July 18, 2019. https://psmag.com/environment/sunscreen-is-corals-biggest-anemone. Accessed December 23, 2019.
  3. Luscombe R. Republicans seek to overturn Key West ban on coral-damaging sunscreens. The Guardian. November 9, 2019. https://www.theguardian.com/us-news/2019/nov/09/key-west-sunscreen-coral-reef-backlash-skin-cancer. Accessed December 23, 2019.
  4. Salazar D. CVS to remove 2 chemicals from 60 store-brand sunscreens. Drug Store News. August 2, 2019. https://drugstorenews.com/retail-news/cvs-to-remove-2-chemicals-from-60-store-brand-sunscreens. Accessed December 23, 2019.
  5. Sunscreen drug products for over-the-counter human use. Fed Registr. 2019;84(38):6204-6275. To be codified at 21 CFR §201, 310, 347, and 352.
  6. DeLeo VA. Sunscreen regulations and advice for your patients. Cutis. 2019;103:251-253.
  7. Matta MK, Zusterzeel R, Pilli NR, et al. Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA. 2019;321:2082-2091.
  8. Mayor de Blasio, health officials declare end of measles outbreak in New York City [news release]. New York, NY: City of New York; September 3, 2019. https://www1.nyc.gov/office-of-the-mayor/news/409-19/mayor-de-blasio-health-officials-declare-end-measles-outbreak-new-york-city. Accessed December 23, 2019.
  9. Health department reports eleven new cases of measles in Brooklyn’s Orthodox Jewish community, urges on time vaccination for all children, especially before traveling to Israel and other countries experiencing measles outbreaks [news release]. New York, NY: City of New York; November 2, 2018. https://www1.nyc.gov/site/doh/about/press/pr2018/pr091-18.page. Accessed December 23, 2019.
  10. Centers for Disease Control and Prevention. Measles elimination. https://www.cdc.gov/measles/elimination.html. Updated October 4, 2019. Accessed December 23, 2019.
  11. McKinley J. Measles outbreak: N.Y. eliminates religious exemptions for vaccinations. New York Times. June 13, 2019. https://www.nytimes.com/2019/06/13/nyregion/measles-vaccinations-new-york.html. Accessed December 23, 2019.
  12. FDA approves Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents [news release]. Cambridge, MA: Sanofi; March 11, 2019. http://www.news.sanofi.us/2019-03-11-FDA-approves-Dupixent-R-dupilumab-for-moderate-to-severe-atopic-dermatitis-in-adolescents. Accessed December 23, 2019.
  13. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial [published online ahead of print November 6, 2019]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.3336.
  14. Galderma receives FDA approval for AKLIEF® (trifarotene) cream, 0.005%, the first new retinoid molecule for the treatment of acne in over 20 years [news release]. Fort Worth, TX: Galderma Laboratories, LP; October 4, 2019. https://www.multivu.com/players/English/8613051-galderma-aklief-retinoid-molecule-acne-treatment/. Accessed December 23, 2019.
  15. Update—Foamix receives FDA approval of AMZEEQ™ topical minocycline treatment for millions of moderate to severe acne sufferers [news release]. Bridgewater, NJ: Foamix Pharmaceuticals Ltd; October 18, 2019. http://www.foamix.com/news-releases/news-release-details/update-foamix-receives-fda-approval-amzeeqtm-topical-minocycline. Accessed December 23, 2019.
  16. Redfearn S. Clinical trial patient inclusion and exclusion criteria need an overhaul, say experts. CenterWatch website. April 23, 2018. https://www.centerwatch.com/cwweekly/2018/04/23/clinical-trial-patient-inclusion-and-exclusion-criteria-need-an-overhaul-say-experts. Accessed December 23, 2019.
  17. Tan J, Thiboutot D, Popp G, et al. Randomized phase 3 evaluation of trifarotene 50 mug/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80:1691-1699.
  18. FDA approves OTEZLA® (apremilast) for the treatment of oral ulcers associated with Behçet’s disease [news release]. Summit, NJ: Celgene; July 19, 2019. https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-OTEZLA-apremilast-for-the-Treatment-of-Oral-Ulcers-Associated-with-Behets-Disease/default.aspx. Accessed December 23, 2019.
  19. Apremilast [package insert]. Summit, NJ: Celgene Corporation; 2019.
  20. FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder [news release]. Silver Spring, MD: US Food and Drug Administration; October 8, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder. Accessed December 23, 2019.
  21. Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med. 2015;373:48-59.
  22. Light Therapy Mask recall statement. Neutrogena website. https://www.neutrogena.com/light-therapy-statement.html. Accessed December 23, 2019.
  23. Bromwich JE. Neutrogena recalls Light Therapy Masks, citing risk of eye injury. New York Times. July 18, 2019. https://www.nytimes.com/2019/07/18/style/neutrogena-light-therapy-mask-recall.html. Accessed December 23, 2019, 2019.
  24. Nguyen T. Neutrogena recalls acne mask over concerns about blue light. Chemical & Engineering News. August 6, 2019. https://cen.acs.org/safety/lab-safety/Neutrogena-recalls-acne-mask-over-concerns-about-blue-light/97/web/2019/08. Accessed November 16, 2019.
  25. Australian Government Department of Health, Therapeutic Goods Administration. Neutrogena Visibly Clear Light Therapy Acne Mask and Activator: Recall - potential for eye damage. https://www.tga.gov.au/alert/neutrogena-visibly-clear-light-therapy-acne-mask-and-activator. Published July 17, 2019. Accessed December 23, 2019.
  26. Johnson & Johnson Consumer Inc. to voluntarily recall a single lot of Johnson’s Baby Powder in the United States [press release]. New Brunswick, NJ: Johnson & Johnson Consumer Inc; October 18, 2019. https://www.factsabouttalc.com/_document/15-new-tests-from-the-same-bottle-of-johnsons-baby-powder-previously-tested-by-fda-find-no-asbestos?id=0000016e-1915-dc68-af7e-df3f147c0000. Accessed December 23, 2019.
  27. 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by FDA find no asbestos [press release]. New Brunswick, NJ: Johnson & Johnson Consumer Inc; October 29, 2019. https://www.factsabouttalc.com/_document/johnson-johnson-consumer-inc-to-voluntarily-recall-a-single-lot-of-johnsons-baby-powder-in-the-united-states?id=0000016d-debf-d71d-a77d-dfbfebeb0000. Accessed December 23, 2019.
  28. Hsu T. Johnson & Johnson says recalled baby powder doesn’t have asbestos. New York Times. October 29, 2019. https://www.nytimes.com/2019/10/29/business/johnson-baby-powder-asbestos.html. Accessed December 23, 2019.
References
  1. Zraick K. Key West bans sunscreen containing chemicals believed to harm coral reefs. New York Times. February 7, 2019. https://www.nytimes.com/2019/02/07/us/sunscreen-coral-reef-key-west.html. Accessed December 23, 2019.
  2. Gies H. The U.S. Virigin Islands becomes the first American jurisdiction to ban common chemical sunscreens. Pacific Standard. July 18, 2019. https://psmag.com/environment/sunscreen-is-corals-biggest-anemone. Accessed December 23, 2019.
  3. Luscombe R. Republicans seek to overturn Key West ban on coral-damaging sunscreens. The Guardian. November 9, 2019. https://www.theguardian.com/us-news/2019/nov/09/key-west-sunscreen-coral-reef-backlash-skin-cancer. Accessed December 23, 2019.
  4. Salazar D. CVS to remove 2 chemicals from 60 store-brand sunscreens. Drug Store News. August 2, 2019. https://drugstorenews.com/retail-news/cvs-to-remove-2-chemicals-from-60-store-brand-sunscreens. Accessed December 23, 2019.
  5. Sunscreen drug products for over-the-counter human use. Fed Registr. 2019;84(38):6204-6275. To be codified at 21 CFR §201, 310, 347, and 352.
  6. DeLeo VA. Sunscreen regulations and advice for your patients. Cutis. 2019;103:251-253.
  7. Matta MK, Zusterzeel R, Pilli NR, et al. Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA. 2019;321:2082-2091.
  8. Mayor de Blasio, health officials declare end of measles outbreak in New York City [news release]. New York, NY: City of New York; September 3, 2019. https://www1.nyc.gov/office-of-the-mayor/news/409-19/mayor-de-blasio-health-officials-declare-end-measles-outbreak-new-york-city. Accessed December 23, 2019.
  9. Health department reports eleven new cases of measles in Brooklyn’s Orthodox Jewish community, urges on time vaccination for all children, especially before traveling to Israel and other countries experiencing measles outbreaks [news release]. New York, NY: City of New York; November 2, 2018. https://www1.nyc.gov/site/doh/about/press/pr2018/pr091-18.page. Accessed December 23, 2019.
  10. Centers for Disease Control and Prevention. Measles elimination. https://www.cdc.gov/measles/elimination.html. Updated October 4, 2019. Accessed December 23, 2019.
  11. McKinley J. Measles outbreak: N.Y. eliminates religious exemptions for vaccinations. New York Times. June 13, 2019. https://www.nytimes.com/2019/06/13/nyregion/measles-vaccinations-new-york.html. Accessed December 23, 2019.
  12. FDA approves Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents [news release]. Cambridge, MA: Sanofi; March 11, 2019. http://www.news.sanofi.us/2019-03-11-FDA-approves-Dupixent-R-dupilumab-for-moderate-to-severe-atopic-dermatitis-in-adolescents. Accessed December 23, 2019.
  13. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial [published online ahead of print November 6, 2019]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.3336.
  14. Galderma receives FDA approval for AKLIEF® (trifarotene) cream, 0.005%, the first new retinoid molecule for the treatment of acne in over 20 years [news release]. Fort Worth, TX: Galderma Laboratories, LP; October 4, 2019. https://www.multivu.com/players/English/8613051-galderma-aklief-retinoid-molecule-acne-treatment/. Accessed December 23, 2019.
  15. Update—Foamix receives FDA approval of AMZEEQ™ topical minocycline treatment for millions of moderate to severe acne sufferers [news release]. Bridgewater, NJ: Foamix Pharmaceuticals Ltd; October 18, 2019. http://www.foamix.com/news-releases/news-release-details/update-foamix-receives-fda-approval-amzeeqtm-topical-minocycline. Accessed December 23, 2019.
  16. Redfearn S. Clinical trial patient inclusion and exclusion criteria need an overhaul, say experts. CenterWatch website. April 23, 2018. https://www.centerwatch.com/cwweekly/2018/04/23/clinical-trial-patient-inclusion-and-exclusion-criteria-need-an-overhaul-say-experts. Accessed December 23, 2019.
  17. Tan J, Thiboutot D, Popp G, et al. Randomized phase 3 evaluation of trifarotene 50 mug/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80:1691-1699.
  18. FDA approves OTEZLA® (apremilast) for the treatment of oral ulcers associated with Behçet’s disease [news release]. Summit, NJ: Celgene; July 19, 2019. https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-OTEZLA-apremilast-for-the-Treatment-of-Oral-Ulcers-Associated-with-Behets-Disease/default.aspx. Accessed December 23, 2019.
  19. Apremilast [package insert]. Summit, NJ: Celgene Corporation; 2019.
  20. FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder [news release]. Silver Spring, MD: US Food and Drug Administration; October 8, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder. Accessed December 23, 2019.
  21. Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med. 2015;373:48-59.
  22. Light Therapy Mask recall statement. Neutrogena website. https://www.neutrogena.com/light-therapy-statement.html. Accessed December 23, 2019.
  23. Bromwich JE. Neutrogena recalls Light Therapy Masks, citing risk of eye injury. New York Times. July 18, 2019. https://www.nytimes.com/2019/07/18/style/neutrogena-light-therapy-mask-recall.html. Accessed December 23, 2019, 2019.
  24. Nguyen T. Neutrogena recalls acne mask over concerns about blue light. Chemical & Engineering News. August 6, 2019. https://cen.acs.org/safety/lab-safety/Neutrogena-recalls-acne-mask-over-concerns-about-blue-light/97/web/2019/08. Accessed November 16, 2019.
  25. Australian Government Department of Health, Therapeutic Goods Administration. Neutrogena Visibly Clear Light Therapy Acne Mask and Activator: Recall - potential for eye damage. https://www.tga.gov.au/alert/neutrogena-visibly-clear-light-therapy-acne-mask-and-activator. Published July 17, 2019. Accessed December 23, 2019.
  26. Johnson & Johnson Consumer Inc. to voluntarily recall a single lot of Johnson’s Baby Powder in the United States [press release]. New Brunswick, NJ: Johnson & Johnson Consumer Inc; October 18, 2019. https://www.factsabouttalc.com/_document/15-new-tests-from-the-same-bottle-of-johnsons-baby-powder-previously-tested-by-fda-find-no-asbestos?id=0000016e-1915-dc68-af7e-df3f147c0000. Accessed December 23, 2019.
  27. 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by FDA find no asbestos [press release]. New Brunswick, NJ: Johnson & Johnson Consumer Inc; October 29, 2019. https://www.factsabouttalc.com/_document/johnson-johnson-consumer-inc-to-voluntarily-recall-a-single-lot-of-johnsons-baby-powder-in-the-united-states?id=0000016d-debf-d71d-a77d-dfbfebeb0000. Accessed December 23, 2019.
  28. Hsu T. Johnson & Johnson says recalled baby powder doesn’t have asbestos. New York Times. October 29, 2019. https://www.nytimes.com/2019/10/29/business/johnson-baby-powder-asbestos.html. Accessed December 23, 2019.
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  • Chemical sunscreen made headlines in 2019 due to concerns over coral reef toxicity and systemic absorption in humans.
  • With a total of 654 cases, New York City’s largest measles outbreak in nearly 30 years ended in September 2019.
  • From dupilumab for adolescent atopic dermatitis to apremilast for Behçet disease, the US Food and Drug Administration approved several therapies for pediatric dermatology and rare dermatologic conditions in 2019.
  • Two popular skin care products—the Neutrogena Light Therapy Acne Mask and Johnson’s Baby Powderwere involved in recalls in 2019.
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Career Choices: Psychiatric oncology

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Career Choices: Psychiatric oncology

Editor’s note: Career Choices features a psychiatry resident/fellow interviewing a psychiatrist about why he or she has chosen a specific career path. The goal is to inform trainees about the various psychiatric career options, and to give them a feel for the pros and cons of the various paths.

In this Career Choices, Saeed Ahmed, MD, Addiction Psychiatry Fellow at Boston University, talked with William Pirl, MD, MPH, FACLP, FAPOS. Dr. Pirl is Associate Professor, Psychiatry, Harvard Medical School. He joined Dana-Farber Cancer Institute in 2018 as Vice Chair for Psychosocial Oncology, Department of Psychosocial Oncology and Palliative Care. He is a past president of the American Psychosocial Oncology Society and North American Associate Editor for the journal Psycho-Oncology.

Dr. Ahmed: What made you choose the psychiatric oncology track, and how did your training lead you towards this path?

Dr. Pirl: I went to medical school thinking that I wanted to be a psychiatrist. However, I was really drawn to internal medicine, especially the process of sorting through medical differential diagnoses. I was deciding between applying for residency in medicine or psychiatry when I did an elective rotation in consultation-liaison (CL) psychiatry. Consultation-liaison psychiatry combined both medicine and psychiatry, which is exactly what I wanted to do. After residency, I wanted to do a CL fellowship outside of Boston, which is where I had done all of my medical education and training. One of my residency advisors suggested Memorial Sloan-Kettering Cancer Center, and I ended up going there. On the first day of fellowship, I realized that I’d only be working with cancer over that year, which I had not really thought about beforehand. Luckily, I loved it, and over the year I realized that the work had tremendous impact and meaning.

Dr. Ahmed: What are some of the pros and cons of working in psychiatric oncology?

Dr. Pirl: Things that I think are pros might be cons for some people. Consults in psychiatric oncology tend to be more relationship-based than they might be in other CL subspecialties. Oncology clinicians want to know who they are referring their patients to, and they are used to team-based care. If you like practicing as part of a multidisciplinary team, this is a pro.

Psychiatric oncology has more focus on existential issues, which interests me more than some other things in psychiatry. Bearing witness to so much tragedy can be a con at times, but psychiatrists who do this work learn ways to manage this within themselves. Psychiatric oncology also offers many experiences where you can see how much impact you make. It’s rewarding to see results and get positive feedback from patients and their families.

Continue to: Lastly, this is...

 

 

Lastly, this is a historic time in oncology. Over the last 15 years, things are happening that I never thought I would live to see. Some patients who 10 or 15 years ago would have had an expected survival of 6 to 9 months are now living years. We are now at a point where we might not actually know a patient’s prognosis, which introduces a whole other layer of uncertainty in cancer. Working as a psychiatrist during this time of rapidly evolving care is amazing. Cancer care will look very different over the next decade.

Dr. Ahmed: Based on your personal experience, what should one consider when choosing a psychiatric oncology program?

Dr. Pirl: I trained in a time before CL was a certified subspecialty of psychiatry. At that time, programs could focus solely on cancer, which cannot be done now. Trainees need to have broader training in certified fellowships. If someone knows that they are interested in psychiatric oncology, there are 2 programs that they should consider: the Dana-Farber Cancer Institute track of the Brigham and Women’s Hospital CL fellowship, and the Memorial Sloan-Kettering Cancer Center/New York Hospital CL fellowship. However, completing a CL fellowship will give someone the skills to do this work, even though they may not know all of the cancer content yet.

Dr. Ahmed: What are some of the career options and work settings in psychiatric oncology?

Dr. Pirl: There are many factors that make it difficult for psychiatrist to have a psychiatric oncology private practice. The amount of late cancellations and no-shows because of illness makes it hard to do this work without some institutional subsidy. Also, being able to communicate and work as a team with oncology providers is much easier if you are in the same place. Most psychiatrists who do psychiatric oncology work in a cancer center or hospital. Practice settings at those places include both inpatient and outpatient work. There is also a shortage of psychiatrists doing this work, which makes it easier to get a job and to advance into leadership roles.

Continue to: Dr. Ahmed...

 

 

Dr. Ahmed: What are some of the challenges in working in this field?

Dr. Pirl: One challenge is figuring out how to make sure you have income doing something that is not financially viable on its own. This is why most people work for cancer centers or hospitals and have some institutional subsidy for their work. Another challenge is access to care. There are not enough psychiatric resources for all the people with cancer who need them. Traditional referral-based models are getting harder and harder to manage. I think the emotional aspects of the work can also be challenging at times.

Dr. Ahmed: Where do you see the field going?

Dr. Pirl: Psychosocial care is now considered part of quality cancer care, and regulations require cancer centers to do certain aspects of it. This is leading to clinical growth and more integration into oncology. However, I am worried that we are not having enough psychiatry residents choose to do CL and/or psychiatric oncology. Some trainees are choosing to do a palliative care fellowship instead. When those trainees tell me why they want to do palliative care, I say that I do all of that and actually have much more time to do it because I am not managing constipation and vent settings. We need to do a better job of making trainees more aware of psychiatric oncology.

Dr. Ahmed: What advice do you have for those contemplating a career in psychiatric oncology?

Dr. Pirl: Please join the field. There is a shortage of psychiatrists who do this work, which is ironically one of the best and most meaningful jobs in psychiatry.

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Dr. Ahmed is an Addiction Psychiatry Fellow, Boston University Medical Center/Boston University School of Medicine, Boston, Massachusetts. Dr. Pirl is Associate Professor, Psychiatry, Harvard Medical School, and Vice Chair for Psychosocial Oncology, Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.

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Editor’s note: Career Choices features a psychiatry resident/fellow interviewing a psychiatrist about why he or she has chosen a specific career path. The goal is to inform trainees about the various psychiatric career options, and to give them a feel for the pros and cons of the various paths.

In this Career Choices, Saeed Ahmed, MD, Addiction Psychiatry Fellow at Boston University, talked with William Pirl, MD, MPH, FACLP, FAPOS. Dr. Pirl is Associate Professor, Psychiatry, Harvard Medical School. He joined Dana-Farber Cancer Institute in 2018 as Vice Chair for Psychosocial Oncology, Department of Psychosocial Oncology and Palliative Care. He is a past president of the American Psychosocial Oncology Society and North American Associate Editor for the journal Psycho-Oncology.

Dr. Ahmed: What made you choose the psychiatric oncology track, and how did your training lead you towards this path?

Dr. Pirl: I went to medical school thinking that I wanted to be a psychiatrist. However, I was really drawn to internal medicine, especially the process of sorting through medical differential diagnoses. I was deciding between applying for residency in medicine or psychiatry when I did an elective rotation in consultation-liaison (CL) psychiatry. Consultation-liaison psychiatry combined both medicine and psychiatry, which is exactly what I wanted to do. After residency, I wanted to do a CL fellowship outside of Boston, which is where I had done all of my medical education and training. One of my residency advisors suggested Memorial Sloan-Kettering Cancer Center, and I ended up going there. On the first day of fellowship, I realized that I’d only be working with cancer over that year, which I had not really thought about beforehand. Luckily, I loved it, and over the year I realized that the work had tremendous impact and meaning.

Dr. Ahmed: What are some of the pros and cons of working in psychiatric oncology?

Dr. Pirl: Things that I think are pros might be cons for some people. Consults in psychiatric oncology tend to be more relationship-based than they might be in other CL subspecialties. Oncology clinicians want to know who they are referring their patients to, and they are used to team-based care. If you like practicing as part of a multidisciplinary team, this is a pro.

Psychiatric oncology has more focus on existential issues, which interests me more than some other things in psychiatry. Bearing witness to so much tragedy can be a con at times, but psychiatrists who do this work learn ways to manage this within themselves. Psychiatric oncology also offers many experiences where you can see how much impact you make. It’s rewarding to see results and get positive feedback from patients and their families.

Continue to: Lastly, this is...

 

 

Lastly, this is a historic time in oncology. Over the last 15 years, things are happening that I never thought I would live to see. Some patients who 10 or 15 years ago would have had an expected survival of 6 to 9 months are now living years. We are now at a point where we might not actually know a patient’s prognosis, which introduces a whole other layer of uncertainty in cancer. Working as a psychiatrist during this time of rapidly evolving care is amazing. Cancer care will look very different over the next decade.

Dr. Ahmed: Based on your personal experience, what should one consider when choosing a psychiatric oncology program?

Dr. Pirl: I trained in a time before CL was a certified subspecialty of psychiatry. At that time, programs could focus solely on cancer, which cannot be done now. Trainees need to have broader training in certified fellowships. If someone knows that they are interested in psychiatric oncology, there are 2 programs that they should consider: the Dana-Farber Cancer Institute track of the Brigham and Women’s Hospital CL fellowship, and the Memorial Sloan-Kettering Cancer Center/New York Hospital CL fellowship. However, completing a CL fellowship will give someone the skills to do this work, even though they may not know all of the cancer content yet.

Dr. Ahmed: What are some of the career options and work settings in psychiatric oncology?

Dr. Pirl: There are many factors that make it difficult for psychiatrist to have a psychiatric oncology private practice. The amount of late cancellations and no-shows because of illness makes it hard to do this work without some institutional subsidy. Also, being able to communicate and work as a team with oncology providers is much easier if you are in the same place. Most psychiatrists who do psychiatric oncology work in a cancer center or hospital. Practice settings at those places include both inpatient and outpatient work. There is also a shortage of psychiatrists doing this work, which makes it easier to get a job and to advance into leadership roles.

Continue to: Dr. Ahmed...

 

 

Dr. Ahmed: What are some of the challenges in working in this field?

Dr. Pirl: One challenge is figuring out how to make sure you have income doing something that is not financially viable on its own. This is why most people work for cancer centers or hospitals and have some institutional subsidy for their work. Another challenge is access to care. There are not enough psychiatric resources for all the people with cancer who need them. Traditional referral-based models are getting harder and harder to manage. I think the emotional aspects of the work can also be challenging at times.

Dr. Ahmed: Where do you see the field going?

Dr. Pirl: Psychosocial care is now considered part of quality cancer care, and regulations require cancer centers to do certain aspects of it. This is leading to clinical growth and more integration into oncology. However, I am worried that we are not having enough psychiatry residents choose to do CL and/or psychiatric oncology. Some trainees are choosing to do a palliative care fellowship instead. When those trainees tell me why they want to do palliative care, I say that I do all of that and actually have much more time to do it because I am not managing constipation and vent settings. We need to do a better job of making trainees more aware of psychiatric oncology.

Dr. Ahmed: What advice do you have for those contemplating a career in psychiatric oncology?

Dr. Pirl: Please join the field. There is a shortage of psychiatrists who do this work, which is ironically one of the best and most meaningful jobs in psychiatry.

Editor’s note: Career Choices features a psychiatry resident/fellow interviewing a psychiatrist about why he or she has chosen a specific career path. The goal is to inform trainees about the various psychiatric career options, and to give them a feel for the pros and cons of the various paths.

In this Career Choices, Saeed Ahmed, MD, Addiction Psychiatry Fellow at Boston University, talked with William Pirl, MD, MPH, FACLP, FAPOS. Dr. Pirl is Associate Professor, Psychiatry, Harvard Medical School. He joined Dana-Farber Cancer Institute in 2018 as Vice Chair for Psychosocial Oncology, Department of Psychosocial Oncology and Palliative Care. He is a past president of the American Psychosocial Oncology Society and North American Associate Editor for the journal Psycho-Oncology.

Dr. Ahmed: What made you choose the psychiatric oncology track, and how did your training lead you towards this path?

Dr. Pirl: I went to medical school thinking that I wanted to be a psychiatrist. However, I was really drawn to internal medicine, especially the process of sorting through medical differential diagnoses. I was deciding between applying for residency in medicine or psychiatry when I did an elective rotation in consultation-liaison (CL) psychiatry. Consultation-liaison psychiatry combined both medicine and psychiatry, which is exactly what I wanted to do. After residency, I wanted to do a CL fellowship outside of Boston, which is where I had done all of my medical education and training. One of my residency advisors suggested Memorial Sloan-Kettering Cancer Center, and I ended up going there. On the first day of fellowship, I realized that I’d only be working with cancer over that year, which I had not really thought about beforehand. Luckily, I loved it, and over the year I realized that the work had tremendous impact and meaning.

Dr. Ahmed: What are some of the pros and cons of working in psychiatric oncology?

Dr. Pirl: Things that I think are pros might be cons for some people. Consults in psychiatric oncology tend to be more relationship-based than they might be in other CL subspecialties. Oncology clinicians want to know who they are referring their patients to, and they are used to team-based care. If you like practicing as part of a multidisciplinary team, this is a pro.

Psychiatric oncology has more focus on existential issues, which interests me more than some other things in psychiatry. Bearing witness to so much tragedy can be a con at times, but psychiatrists who do this work learn ways to manage this within themselves. Psychiatric oncology also offers many experiences where you can see how much impact you make. It’s rewarding to see results and get positive feedback from patients and their families.

Continue to: Lastly, this is...

 

 

Lastly, this is a historic time in oncology. Over the last 15 years, things are happening that I never thought I would live to see. Some patients who 10 or 15 years ago would have had an expected survival of 6 to 9 months are now living years. We are now at a point where we might not actually know a patient’s prognosis, which introduces a whole other layer of uncertainty in cancer. Working as a psychiatrist during this time of rapidly evolving care is amazing. Cancer care will look very different over the next decade.

Dr. Ahmed: Based on your personal experience, what should one consider when choosing a psychiatric oncology program?

Dr. Pirl: I trained in a time before CL was a certified subspecialty of psychiatry. At that time, programs could focus solely on cancer, which cannot be done now. Trainees need to have broader training in certified fellowships. If someone knows that they are interested in psychiatric oncology, there are 2 programs that they should consider: the Dana-Farber Cancer Institute track of the Brigham and Women’s Hospital CL fellowship, and the Memorial Sloan-Kettering Cancer Center/New York Hospital CL fellowship. However, completing a CL fellowship will give someone the skills to do this work, even though they may not know all of the cancer content yet.

Dr. Ahmed: What are some of the career options and work settings in psychiatric oncology?

Dr. Pirl: There are many factors that make it difficult for psychiatrist to have a psychiatric oncology private practice. The amount of late cancellations and no-shows because of illness makes it hard to do this work without some institutional subsidy. Also, being able to communicate and work as a team with oncology providers is much easier if you are in the same place. Most psychiatrists who do psychiatric oncology work in a cancer center or hospital. Practice settings at those places include both inpatient and outpatient work. There is also a shortage of psychiatrists doing this work, which makes it easier to get a job and to advance into leadership roles.

Continue to: Dr. Ahmed...

 

 

Dr. Ahmed: What are some of the challenges in working in this field?

Dr. Pirl: One challenge is figuring out how to make sure you have income doing something that is not financially viable on its own. This is why most people work for cancer centers or hospitals and have some institutional subsidy for their work. Another challenge is access to care. There are not enough psychiatric resources for all the people with cancer who need them. Traditional referral-based models are getting harder and harder to manage. I think the emotional aspects of the work can also be challenging at times.

Dr. Ahmed: Where do you see the field going?

Dr. Pirl: Psychosocial care is now considered part of quality cancer care, and regulations require cancer centers to do certain aspects of it. This is leading to clinical growth and more integration into oncology. However, I am worried that we are not having enough psychiatry residents choose to do CL and/or psychiatric oncology. Some trainees are choosing to do a palliative care fellowship instead. When those trainees tell me why they want to do palliative care, I say that I do all of that and actually have much more time to do it because I am not managing constipation and vent settings. We need to do a better job of making trainees more aware of psychiatric oncology.

Dr. Ahmed: What advice do you have for those contemplating a career in psychiatric oncology?

Dr. Pirl: Please join the field. There is a shortage of psychiatrists who do this work, which is ironically one of the best and most meaningful jobs in psychiatry.

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Reducing the Cost of Dermatology Residency Applications: An Applicant’s Perspective

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Another Match Day is approaching. Students find themselves paying more each year to apply to one of the most competitive fields, while program directors struggle to sort through hundreds of stellar applications to invite a handful of candidates for interviews. Estimates place the cost of the application process at $5 million in total for all medical school seniors, or roughly $10,000 per applicant.1 Approximately 60% of these costs occur during the interview process.1,2 In an era in which students routinely graduate medical school with hundreds of thousands of dollars of debt, these costs must be addressed as soon as possible.

This problem is not unique to dermatology; otolaryngology, another especially competitive field, has considered various changes to the match process based on applicants’ feedback.3 As an applicant during the 2018-2019 match cycle for dermatology, I offer 2 solutions that are a starting point aimed at streamlining the application process for both applicants and program directors: regional interview coordination and a cap on the number of residency applications.

Regional Interview Coordination

Regional interview coordination would reduce travel costs and facilitate greater predictability in scheduling clinical rotations. In the current climate, it is not uncommon for applicants to make multiple cross-country round trips in the same week, especially given that the interview season for dermatology, including interviews for preliminary programs, now ranges from mid-October to early February. Although affluent applicants may not be concerned with financial costs of frequent travel, all applicants face travel inconveniences that could be mitigated through regional coordination. For example, an applicant invited to multiple interviews in the New York City area could reserve a room in a single hotel over a period of several days. During each interview day, he/she could travel back and forth from that accommodation to each institution without needing to bring luggage, worrying about reaching the airport on time, or missing a pre-interview dinner at a program in a faraway city.

Given the amount of coordination required among programs, it may lead to more positive working relationships among regional dermatology programs. One limitation of this approach is that competitive programs may be unwilling to cooperate. If even one program deviates from the interview time frame, it reduces the incentive for others to participate. Programs must be willing to sacrifice short-term autonomy in interview scheduling for their long-term shared interest in reducing the application burden for students, which is known as a commitment problem in game theory, and could be addressed through joint decision-making that incorporates the time frame preferences of all programs as well as binding commitments on interview dates that are decided before the process begins.4 Another limitation is that inclement weather could affect all regional programs simultaneously. In this case, offering interviews via video conference for affected students may be a solution.

Capping the Number of Applications

A second method of reducing interview costs would be capping the number of applications. Although matched seniors applied to a median of 72 programs, the Association of American Medical Colleges suggests that dermatology applicants can maximize their return on investment (ie, ratio of interviews to applications) by sending 35 to 55 applications depending on US Medical Licensing Examination scores. Attending more than 10 interviews does not meaningfully improve the chance of matching.5,6

 

 

Programs have limited capacity for interviews and must judiciously allocate invitations based solely on the information provided through the Electronic Residency Application Service (ERAS). Given the competitiveness of dermatology, applicants usually will accept every interview invitation. Therefore, applicants who are not genuinely interested in a program may crowd out others who are interested. In a survey of otolaryngology applicants (N=150), 90.6% of respondents admitted applying to programs in which they had no specific interest, simply to increase their chance of matching.3 Capping application numbers would force students to apply more selectively and enable residencies to gauge students’ true interest more effectively. In contrast to regional interview coordination, this policy change would be easy to enforce. It also may be popular; nearly two-thirds of otolaryngology applicants agreed to a hypothetical cap on residency applications to reduce the burden on students and programs.3



An alternative to a hard cap on applications could be restructuring the ERAS application fee to incentivize students to apply to fewer programs. For example, a flat fee might cover application numbers up to the point of diminishing returns, after which the price per application could increase exponentially. This approach would have a similar effect of a hard cap and cause many students to apply to fewer programs; however, one notable drawback is that highly affluent applicants would simply absorb the extra cost and still gain a competitive advantage in applying to more programs, which might further decrease the number of lower-income individuals successfully matching into dermatology.

A benefit of decreased application numbers to program directors would be giving them more time to conduct a holistic review of applicants, rather than attempting to weed out candidates through arbitrary cutoffs for US Medical Licensing Examination scores or Alpha Omega Alpha Honor Medical Society membership. The ERAS could allow applicants the option of stating preferences for geographic regions, desired fellowships, areas of research interest, and other intangible metrics. Selection committees could filter their candidate search by different variables and then look at each candidate holistically.



Limitations of capping application numbers include the risk that such a cap would harm less-competitive applicants while failing to address the primary cost drivers (ie, travel costs). The specific cap number would be controversial and may need to be adjusted higher for special cases such as couples matching and international applicants, thus making a cap seem arbitrary.

Final Thoughts

The dermatology residency match can be streamlined to the benefit of both applicants and selection committees. Regional interview coordination would reduce both financial and logistical barriers for applicants but may be difficult to enforce without cooperation from multiple programs. Capping the number of applications, either through a hard cap or an increased financial barrier, would be relatively easy to enforce and might empower selection committees to conduct more detailed, holistic reviews of applicants; however, certain types of applicants may find the application limits detrimental to their chances of matching. These policy recommendations are meant to be a starting point for discussion. Streamlining the application process is critical to improving the diversity of dermatology residencies.

References
  1. Mansouri B, Walker GD, Mitchell J, et al. The cost of applying to dermatology residency: 2014 data estimates. J Am Acad Dermatol. 2016;74:754-756.
  2. Tichy AL, Peng DH, Lane AT. Applying for dermatology residency is difficult and expensive. J Am Acad Dermatol. 2012;66:696-697.
  3. Ward M, Pingree C, Laury AM, et al. Applicant perspectives on the otolaryngology residency application process. JAMA Otolaryngol Head Neck Surg. 2017;143:782-787.
  4. North DC. Institutions and credible commitment. J Inst Theor Econ. 1993;149:11-23.
  5. Association of American Medical Colleges. Apply smart: data to consider when applying to residency. https://students-residents.aamc.org/applying-residency/filteredresult/apply-smart-data-consider-when-applying-residency/. Accessed November 12, 2019.
  6. Charting Outcomes in the Match: Characteristics of U.S. Allopathic Seniors Who Matched to Their Preferred Specialty in the 2018 Main Residency Match. 2nd ed. Washington, DC: National Resident Matching Program; July 2018. https://www.nrmp.org/wp-content/uploads/2018/06/Charting-Outcomes-in-the-Match-2018-Seniors.pdf. Accessed November 11, 2019.
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Another Match Day is approaching. Students find themselves paying more each year to apply to one of the most competitive fields, while program directors struggle to sort through hundreds of stellar applications to invite a handful of candidates for interviews. Estimates place the cost of the application process at $5 million in total for all medical school seniors, or roughly $10,000 per applicant.1 Approximately 60% of these costs occur during the interview process.1,2 In an era in which students routinely graduate medical school with hundreds of thousands of dollars of debt, these costs must be addressed as soon as possible.

This problem is not unique to dermatology; otolaryngology, another especially competitive field, has considered various changes to the match process based on applicants’ feedback.3 As an applicant during the 2018-2019 match cycle for dermatology, I offer 2 solutions that are a starting point aimed at streamlining the application process for both applicants and program directors: regional interview coordination and a cap on the number of residency applications.

Regional Interview Coordination

Regional interview coordination would reduce travel costs and facilitate greater predictability in scheduling clinical rotations. In the current climate, it is not uncommon for applicants to make multiple cross-country round trips in the same week, especially given that the interview season for dermatology, including interviews for preliminary programs, now ranges from mid-October to early February. Although affluent applicants may not be concerned with financial costs of frequent travel, all applicants face travel inconveniences that could be mitigated through regional coordination. For example, an applicant invited to multiple interviews in the New York City area could reserve a room in a single hotel over a period of several days. During each interview day, he/she could travel back and forth from that accommodation to each institution without needing to bring luggage, worrying about reaching the airport on time, or missing a pre-interview dinner at a program in a faraway city.

Given the amount of coordination required among programs, it may lead to more positive working relationships among regional dermatology programs. One limitation of this approach is that competitive programs may be unwilling to cooperate. If even one program deviates from the interview time frame, it reduces the incentive for others to participate. Programs must be willing to sacrifice short-term autonomy in interview scheduling for their long-term shared interest in reducing the application burden for students, which is known as a commitment problem in game theory, and could be addressed through joint decision-making that incorporates the time frame preferences of all programs as well as binding commitments on interview dates that are decided before the process begins.4 Another limitation is that inclement weather could affect all regional programs simultaneously. In this case, offering interviews via video conference for affected students may be a solution.

Capping the Number of Applications

A second method of reducing interview costs would be capping the number of applications. Although matched seniors applied to a median of 72 programs, the Association of American Medical Colleges suggests that dermatology applicants can maximize their return on investment (ie, ratio of interviews to applications) by sending 35 to 55 applications depending on US Medical Licensing Examination scores. Attending more than 10 interviews does not meaningfully improve the chance of matching.5,6

 

 

Programs have limited capacity for interviews and must judiciously allocate invitations based solely on the information provided through the Electronic Residency Application Service (ERAS). Given the competitiveness of dermatology, applicants usually will accept every interview invitation. Therefore, applicants who are not genuinely interested in a program may crowd out others who are interested. In a survey of otolaryngology applicants (N=150), 90.6% of respondents admitted applying to programs in which they had no specific interest, simply to increase their chance of matching.3 Capping application numbers would force students to apply more selectively and enable residencies to gauge students’ true interest more effectively. In contrast to regional interview coordination, this policy change would be easy to enforce. It also may be popular; nearly two-thirds of otolaryngology applicants agreed to a hypothetical cap on residency applications to reduce the burden on students and programs.3



An alternative to a hard cap on applications could be restructuring the ERAS application fee to incentivize students to apply to fewer programs. For example, a flat fee might cover application numbers up to the point of diminishing returns, after which the price per application could increase exponentially. This approach would have a similar effect of a hard cap and cause many students to apply to fewer programs; however, one notable drawback is that highly affluent applicants would simply absorb the extra cost and still gain a competitive advantage in applying to more programs, which might further decrease the number of lower-income individuals successfully matching into dermatology.

A benefit of decreased application numbers to program directors would be giving them more time to conduct a holistic review of applicants, rather than attempting to weed out candidates through arbitrary cutoffs for US Medical Licensing Examination scores or Alpha Omega Alpha Honor Medical Society membership. The ERAS could allow applicants the option of stating preferences for geographic regions, desired fellowships, areas of research interest, and other intangible metrics. Selection committees could filter their candidate search by different variables and then look at each candidate holistically.



Limitations of capping application numbers include the risk that such a cap would harm less-competitive applicants while failing to address the primary cost drivers (ie, travel costs). The specific cap number would be controversial and may need to be adjusted higher for special cases such as couples matching and international applicants, thus making a cap seem arbitrary.

Final Thoughts

The dermatology residency match can be streamlined to the benefit of both applicants and selection committees. Regional interview coordination would reduce both financial and logistical barriers for applicants but may be difficult to enforce without cooperation from multiple programs. Capping the number of applications, either through a hard cap or an increased financial barrier, would be relatively easy to enforce and might empower selection committees to conduct more detailed, holistic reviews of applicants; however, certain types of applicants may find the application limits detrimental to their chances of matching. These policy recommendations are meant to be a starting point for discussion. Streamlining the application process is critical to improving the diversity of dermatology residencies.

Another Match Day is approaching. Students find themselves paying more each year to apply to one of the most competitive fields, while program directors struggle to sort through hundreds of stellar applications to invite a handful of candidates for interviews. Estimates place the cost of the application process at $5 million in total for all medical school seniors, or roughly $10,000 per applicant.1 Approximately 60% of these costs occur during the interview process.1,2 In an era in which students routinely graduate medical school with hundreds of thousands of dollars of debt, these costs must be addressed as soon as possible.

This problem is not unique to dermatology; otolaryngology, another especially competitive field, has considered various changes to the match process based on applicants’ feedback.3 As an applicant during the 2018-2019 match cycle for dermatology, I offer 2 solutions that are a starting point aimed at streamlining the application process for both applicants and program directors: regional interview coordination and a cap on the number of residency applications.

Regional Interview Coordination

Regional interview coordination would reduce travel costs and facilitate greater predictability in scheduling clinical rotations. In the current climate, it is not uncommon for applicants to make multiple cross-country round trips in the same week, especially given that the interview season for dermatology, including interviews for preliminary programs, now ranges from mid-October to early February. Although affluent applicants may not be concerned with financial costs of frequent travel, all applicants face travel inconveniences that could be mitigated through regional coordination. For example, an applicant invited to multiple interviews in the New York City area could reserve a room in a single hotel over a period of several days. During each interview day, he/she could travel back and forth from that accommodation to each institution without needing to bring luggage, worrying about reaching the airport on time, or missing a pre-interview dinner at a program in a faraway city.

Given the amount of coordination required among programs, it may lead to more positive working relationships among regional dermatology programs. One limitation of this approach is that competitive programs may be unwilling to cooperate. If even one program deviates from the interview time frame, it reduces the incentive for others to participate. Programs must be willing to sacrifice short-term autonomy in interview scheduling for their long-term shared interest in reducing the application burden for students, which is known as a commitment problem in game theory, and could be addressed through joint decision-making that incorporates the time frame preferences of all programs as well as binding commitments on interview dates that are decided before the process begins.4 Another limitation is that inclement weather could affect all regional programs simultaneously. In this case, offering interviews via video conference for affected students may be a solution.

Capping the Number of Applications

A second method of reducing interview costs would be capping the number of applications. Although matched seniors applied to a median of 72 programs, the Association of American Medical Colleges suggests that dermatology applicants can maximize their return on investment (ie, ratio of interviews to applications) by sending 35 to 55 applications depending on US Medical Licensing Examination scores. Attending more than 10 interviews does not meaningfully improve the chance of matching.5,6

 

 

Programs have limited capacity for interviews and must judiciously allocate invitations based solely on the information provided through the Electronic Residency Application Service (ERAS). Given the competitiveness of dermatology, applicants usually will accept every interview invitation. Therefore, applicants who are not genuinely interested in a program may crowd out others who are interested. In a survey of otolaryngology applicants (N=150), 90.6% of respondents admitted applying to programs in which they had no specific interest, simply to increase their chance of matching.3 Capping application numbers would force students to apply more selectively and enable residencies to gauge students’ true interest more effectively. In contrast to regional interview coordination, this policy change would be easy to enforce. It also may be popular; nearly two-thirds of otolaryngology applicants agreed to a hypothetical cap on residency applications to reduce the burden on students and programs.3



An alternative to a hard cap on applications could be restructuring the ERAS application fee to incentivize students to apply to fewer programs. For example, a flat fee might cover application numbers up to the point of diminishing returns, after which the price per application could increase exponentially. This approach would have a similar effect of a hard cap and cause many students to apply to fewer programs; however, one notable drawback is that highly affluent applicants would simply absorb the extra cost and still gain a competitive advantage in applying to more programs, which might further decrease the number of lower-income individuals successfully matching into dermatology.

A benefit of decreased application numbers to program directors would be giving them more time to conduct a holistic review of applicants, rather than attempting to weed out candidates through arbitrary cutoffs for US Medical Licensing Examination scores or Alpha Omega Alpha Honor Medical Society membership. The ERAS could allow applicants the option of stating preferences for geographic regions, desired fellowships, areas of research interest, and other intangible metrics. Selection committees could filter their candidate search by different variables and then look at each candidate holistically.



Limitations of capping application numbers include the risk that such a cap would harm less-competitive applicants while failing to address the primary cost drivers (ie, travel costs). The specific cap number would be controversial and may need to be adjusted higher for special cases such as couples matching and international applicants, thus making a cap seem arbitrary.

Final Thoughts

The dermatology residency match can be streamlined to the benefit of both applicants and selection committees. Regional interview coordination would reduce both financial and logistical barriers for applicants but may be difficult to enforce without cooperation from multiple programs. Capping the number of applications, either through a hard cap or an increased financial barrier, would be relatively easy to enforce and might empower selection committees to conduct more detailed, holistic reviews of applicants; however, certain types of applicants may find the application limits detrimental to their chances of matching. These policy recommendations are meant to be a starting point for discussion. Streamlining the application process is critical to improving the diversity of dermatology residencies.

References
  1. Mansouri B, Walker GD, Mitchell J, et al. The cost of applying to dermatology residency: 2014 data estimates. J Am Acad Dermatol. 2016;74:754-756.
  2. Tichy AL, Peng DH, Lane AT. Applying for dermatology residency is difficult and expensive. J Am Acad Dermatol. 2012;66:696-697.
  3. Ward M, Pingree C, Laury AM, et al. Applicant perspectives on the otolaryngology residency application process. JAMA Otolaryngol Head Neck Surg. 2017;143:782-787.
  4. North DC. Institutions and credible commitment. J Inst Theor Econ. 1993;149:11-23.
  5. Association of American Medical Colleges. Apply smart: data to consider when applying to residency. https://students-residents.aamc.org/applying-residency/filteredresult/apply-smart-data-consider-when-applying-residency/. Accessed November 12, 2019.
  6. Charting Outcomes in the Match: Characteristics of U.S. Allopathic Seniors Who Matched to Their Preferred Specialty in the 2018 Main Residency Match. 2nd ed. Washington, DC: National Resident Matching Program; July 2018. https://www.nrmp.org/wp-content/uploads/2018/06/Charting-Outcomes-in-the-Match-2018-Seniors.pdf. Accessed November 11, 2019.
References
  1. Mansouri B, Walker GD, Mitchell J, et al. The cost of applying to dermatology residency: 2014 data estimates. J Am Acad Dermatol. 2016;74:754-756.
  2. Tichy AL, Peng DH, Lane AT. Applying for dermatology residency is difficult and expensive. J Am Acad Dermatol. 2012;66:696-697.
  3. Ward M, Pingree C, Laury AM, et al. Applicant perspectives on the otolaryngology residency application process. JAMA Otolaryngol Head Neck Surg. 2017;143:782-787.
  4. North DC. Institutions and credible commitment. J Inst Theor Econ. 1993;149:11-23.
  5. Association of American Medical Colleges. Apply smart: data to consider when applying to residency. https://students-residents.aamc.org/applying-residency/filteredresult/apply-smart-data-consider-when-applying-residency/. Accessed November 12, 2019.
  6. Charting Outcomes in the Match: Characteristics of U.S. Allopathic Seniors Who Matched to Their Preferred Specialty in the 2018 Main Residency Match. 2nd ed. Washington, DC: National Resident Matching Program; July 2018. https://www.nrmp.org/wp-content/uploads/2018/06/Charting-Outcomes-in-the-Match-2018-Seniors.pdf. Accessed November 11, 2019.
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Geriatric Psychiatry Fellowship Position

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Geriatric Psychiatry Fellowship Position Available effective July 1, 2020

Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center

Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.

Interested applicants can contact Marcelle Shidler, Program Coordinator, at [email protected] or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry

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Geriatric Psychiatry Fellowship Position Available effective July 1, 2020

Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center

Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.

Interested applicants can contact Marcelle Shidler, Program Coordinator, at [email protected] or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry

Geriatric Psychiatry Fellowship Position Available effective July 1, 2020

Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center

Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.

Interested applicants can contact Marcelle Shidler, Program Coordinator, at [email protected] or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry

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Don’t Forget These 5 Things When Treating Hidradenitis Suppurativa

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Hidradenitis suppurativa (HS) is a common and debilitating inflammatory disorder of the pilosebaceous unit that presents with recurrent scarring inflammatory nodules and sinus tracts in the intertriginous folds of the body. It is a complex condition that requires multimodal management to address the medical, surgical, and psychosocial needs of affected patients. However, it can be difficult to coordinate all that goes into HS management beyond the standard therapeutic ladder of topical and oral antimicrobials, intralesional corticosteroids, biologics, and surgery. In this article, I will outline 5 important aspects of HS treatment that often are overlooked.

Talk About Pathophysiology

Patients with HS often have limited understanding of their condition. One common misperception is that HS is an infectious disease and that disease activity is associated with poor hygiene.1 Dispelling this myth may help patients avoid unnecessary hygiene practices, decrease perceived stigma, and enhance your therapeutic alliance.

The current model of HS pathophysiology implicates an aberrant inflammatory response to the cutaneous bacterial microbiome, which leads to follicular occlusion and then rupture of debris and bacteria into the surrounding dermis. Immune cells and inflammatory mediators such as nuclear factor κB and tumor necrosis factor α respond to the disruption. Chronic lesions develop due to tissue repair with scarring and re-epithelialization.2,3 Although most patients probably are not interested in the esoteric details, I typically make a point of explaining to patients that HS is a chronic inflammatory disease and provide reassurance that it is not a sign of poor hygiene. 

Counsel on Smoking Cessation

Most HS patients use tobacco. As many as 75% of HS patients are active smokers and another 10% to 15% are former smokers. Although there is mixed evidence that disease activity correlates with smoking status, the Hidradenitis Suppurativa Foundation in the United States and Canada concluded in the 2019 North American Clinical Management Guidelines for Hidradenitis Suppurativa that due to the overall health risks of smoking, we should recommend cessation to our patients.4

Laser Hair Removal Works

Don’t forget about laser hair removal! Evidence from randomized controlled trials supports the use of the Nd:YAG laser in the treatment of HS. Treat the entire affected anatomic area and use stacked double pulses on active nodules (typical settings: 10-mm spot size; 10-millisecond pulse duration and 35–50 J/cm2 in Fitzpatrick skin types I–III; 20-millisecond pulse duration and 25–40 J/cm2 in Fitzpatrick skin types IV–VI).4 Especially if it is covered by your patient’s insurance, Nd:YAG is a great adjunctive treatment to consider. The guidelines also recommend long-pulsed alexandrite and diode lasers as well as intense pulsed light, all of which result in follicular destruction, though these treatments have less supporting evidence.4

Have a Plan for Flares

Intralesional injection of triamcinolone is a mainstay of HS treatment and provides patients with rapid relief of symptoms during a flare.5 One case series found that there was a notable decrease in pain, size, and drainage after just 1 day of treatment with intralesional triamcinolone 10 mg/mL (0.2–2.0 mL).6

Intralesional steroid injection is a great tool for quieting an active disease flare while simultaneously instating ongoing treatment for preventive management. However, even when disease control is optimized, patients may still experience intermittent flares of disease. For some patients, it may be appropriate to have a plan in place for a return to clinic during the beginning of a flare to obtain intralesional steroids. The ability to come in on short notice may help avoid visits to the emergency department and urgent care where your patients may receive treatments such as short courses of antibiotics or incision and drainage that may deviate from your overall treatment plan.

Consider Childbearing Status

Don’t forget to consider childbearing plans and childbearing potential when treating female patients with HS. Pregnancy is a frequent consideration in HS patients, as HS affects 3 to 4 times more women than men and typically presents after puberty (second or third decades of life). Many of the medications in the HS armamentarium are contraindicated in pregnancy including tetracyclines, retinoids, and hormonal agents. Surgery should be avoided in pregnant patients whenever possible, particularly in the first trimester. Relatively safe options include topical antibiotics such as clindamycin and metronidazole, as well as tumor necrosis factor α inhibitors, which are classified as category B in pregnancy.5

Before making treatment decisions in pregnant and breastfeeding patients, consult the US Food and Drug Administration recommendations. Perng et al7 reviewed current management strategies for HS in pregnant and breastfeeding women, and their review article in the Journal of the American Academy of Dermatology is an excellent resource.

Final Thoughts

Comprehensive management of HS may include a combination of medication and procedures, lifestyle modification, management of comorbidities, and social support. Formulating a good treatment plan may be a challenge but can drastically improve your patient’s quality of life.

References
  1. What is hidradenitis suppurativa? Hidradenitis Suppurativa Foundation website. https://www.hs-foundation.org/what-is-hs. Accessed October 9, 2019. 
  2. Frew JW, Hawkes JE, Krueger JG. Topical, systemic and biologic therapies in hidradenitis suppurativa: pathogenic insights by examining therapeutic mechanisms. Ther Adv Chronic Dis. 2019;10:2040622319830646. doi:10.1177/2040622319830646 
  3. Lacarrubba F, Musumeci ML, Nasca MR, et al. Double-ended pseudocomedones in hidradenitis suppurativa: clinical, dermoscopic, and histopathological correlation. Acta Derm Venereol. 2017;97:763-764. 
  4. Alikhan A, Sayed C, Alavi A, et al. North American Clinical Management Guidelines for Hidradenitis Suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. part I: diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019;81:76-90. 
  5. Alikhan A, Sayed C, Alavi A, et al. North American Clinical Management Guidelines for Hidradenitis Suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81:91-101. 
  6. Riis PT, Boer J, Prens EP, et al. Intralesional triamcinolone for flares of hidradenitis suppurativa (HS): a case series. J Am Acad Dermatol. 2016;75:1151-1155. 
  7. Perng P, Zampella JG, Okoye GA. Management of hidradenitis suppurativa in pregnancy. J Am Acad Dermatol. 2017;76:979-989.  
     
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The author reports no conflict of interest.

Correspondence: Elisabeth H. Tracey, MD, Department of Dermatology, 9500 Euclid Ave, A60, Cleveland, OH 44195 ([email protected]).

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Correspondence: Elisabeth H. Tracey, MD, Department of Dermatology, 9500 Euclid Ave, A60, Cleveland, OH 44195 ([email protected]).

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Hidradenitis suppurativa (HS) is a common and debilitating inflammatory disorder of the pilosebaceous unit that presents with recurrent scarring inflammatory nodules and sinus tracts in the intertriginous folds of the body. It is a complex condition that requires multimodal management to address the medical, surgical, and psychosocial needs of affected patients. However, it can be difficult to coordinate all that goes into HS management beyond the standard therapeutic ladder of topical and oral antimicrobials, intralesional corticosteroids, biologics, and surgery. In this article, I will outline 5 important aspects of HS treatment that often are overlooked.

Talk About Pathophysiology

Patients with HS often have limited understanding of their condition. One common misperception is that HS is an infectious disease and that disease activity is associated with poor hygiene.1 Dispelling this myth may help patients avoid unnecessary hygiene practices, decrease perceived stigma, and enhance your therapeutic alliance.

The current model of HS pathophysiology implicates an aberrant inflammatory response to the cutaneous bacterial microbiome, which leads to follicular occlusion and then rupture of debris and bacteria into the surrounding dermis. Immune cells and inflammatory mediators such as nuclear factor κB and tumor necrosis factor α respond to the disruption. Chronic lesions develop due to tissue repair with scarring and re-epithelialization.2,3 Although most patients probably are not interested in the esoteric details, I typically make a point of explaining to patients that HS is a chronic inflammatory disease and provide reassurance that it is not a sign of poor hygiene. 

Counsel on Smoking Cessation

Most HS patients use tobacco. As many as 75% of HS patients are active smokers and another 10% to 15% are former smokers. Although there is mixed evidence that disease activity correlates with smoking status, the Hidradenitis Suppurativa Foundation in the United States and Canada concluded in the 2019 North American Clinical Management Guidelines for Hidradenitis Suppurativa that due to the overall health risks of smoking, we should recommend cessation to our patients.4

Laser Hair Removal Works

Don’t forget about laser hair removal! Evidence from randomized controlled trials supports the use of the Nd:YAG laser in the treatment of HS. Treat the entire affected anatomic area and use stacked double pulses on active nodules (typical settings: 10-mm spot size; 10-millisecond pulse duration and 35–50 J/cm2 in Fitzpatrick skin types I–III; 20-millisecond pulse duration and 25–40 J/cm2 in Fitzpatrick skin types IV–VI).4 Especially if it is covered by your patient’s insurance, Nd:YAG is a great adjunctive treatment to consider. The guidelines also recommend long-pulsed alexandrite and diode lasers as well as intense pulsed light, all of which result in follicular destruction, though these treatments have less supporting evidence.4

Have a Plan for Flares

Intralesional injection of triamcinolone is a mainstay of HS treatment and provides patients with rapid relief of symptoms during a flare.5 One case series found that there was a notable decrease in pain, size, and drainage after just 1 day of treatment with intralesional triamcinolone 10 mg/mL (0.2–2.0 mL).6

Intralesional steroid injection is a great tool for quieting an active disease flare while simultaneously instating ongoing treatment for preventive management. However, even when disease control is optimized, patients may still experience intermittent flares of disease. For some patients, it may be appropriate to have a plan in place for a return to clinic during the beginning of a flare to obtain intralesional steroids. The ability to come in on short notice may help avoid visits to the emergency department and urgent care where your patients may receive treatments such as short courses of antibiotics or incision and drainage that may deviate from your overall treatment plan.

Consider Childbearing Status

Don’t forget to consider childbearing plans and childbearing potential when treating female patients with HS. Pregnancy is a frequent consideration in HS patients, as HS affects 3 to 4 times more women than men and typically presents after puberty (second or third decades of life). Many of the medications in the HS armamentarium are contraindicated in pregnancy including tetracyclines, retinoids, and hormonal agents. Surgery should be avoided in pregnant patients whenever possible, particularly in the first trimester. Relatively safe options include topical antibiotics such as clindamycin and metronidazole, as well as tumor necrosis factor α inhibitors, which are classified as category B in pregnancy.5

Before making treatment decisions in pregnant and breastfeeding patients, consult the US Food and Drug Administration recommendations. Perng et al7 reviewed current management strategies for HS in pregnant and breastfeeding women, and their review article in the Journal of the American Academy of Dermatology is an excellent resource.

Final Thoughts

Comprehensive management of HS may include a combination of medication and procedures, lifestyle modification, management of comorbidities, and social support. Formulating a good treatment plan may be a challenge but can drastically improve your patient’s quality of life.

Hidradenitis suppurativa (HS) is a common and debilitating inflammatory disorder of the pilosebaceous unit that presents with recurrent scarring inflammatory nodules and sinus tracts in the intertriginous folds of the body. It is a complex condition that requires multimodal management to address the medical, surgical, and psychosocial needs of affected patients. However, it can be difficult to coordinate all that goes into HS management beyond the standard therapeutic ladder of topical and oral antimicrobials, intralesional corticosteroids, biologics, and surgery. In this article, I will outline 5 important aspects of HS treatment that often are overlooked.

Talk About Pathophysiology

Patients with HS often have limited understanding of their condition. One common misperception is that HS is an infectious disease and that disease activity is associated with poor hygiene.1 Dispelling this myth may help patients avoid unnecessary hygiene practices, decrease perceived stigma, and enhance your therapeutic alliance.

The current model of HS pathophysiology implicates an aberrant inflammatory response to the cutaneous bacterial microbiome, which leads to follicular occlusion and then rupture of debris and bacteria into the surrounding dermis. Immune cells and inflammatory mediators such as nuclear factor κB and tumor necrosis factor α respond to the disruption. Chronic lesions develop due to tissue repair with scarring and re-epithelialization.2,3 Although most patients probably are not interested in the esoteric details, I typically make a point of explaining to patients that HS is a chronic inflammatory disease and provide reassurance that it is not a sign of poor hygiene. 

Counsel on Smoking Cessation

Most HS patients use tobacco. As many as 75% of HS patients are active smokers and another 10% to 15% are former smokers. Although there is mixed evidence that disease activity correlates with smoking status, the Hidradenitis Suppurativa Foundation in the United States and Canada concluded in the 2019 North American Clinical Management Guidelines for Hidradenitis Suppurativa that due to the overall health risks of smoking, we should recommend cessation to our patients.4

Laser Hair Removal Works

Don’t forget about laser hair removal! Evidence from randomized controlled trials supports the use of the Nd:YAG laser in the treatment of HS. Treat the entire affected anatomic area and use stacked double pulses on active nodules (typical settings: 10-mm spot size; 10-millisecond pulse duration and 35–50 J/cm2 in Fitzpatrick skin types I–III; 20-millisecond pulse duration and 25–40 J/cm2 in Fitzpatrick skin types IV–VI).4 Especially if it is covered by your patient’s insurance, Nd:YAG is a great adjunctive treatment to consider. The guidelines also recommend long-pulsed alexandrite and diode lasers as well as intense pulsed light, all of which result in follicular destruction, though these treatments have less supporting evidence.4

Have a Plan for Flares

Intralesional injection of triamcinolone is a mainstay of HS treatment and provides patients with rapid relief of symptoms during a flare.5 One case series found that there was a notable decrease in pain, size, and drainage after just 1 day of treatment with intralesional triamcinolone 10 mg/mL (0.2–2.0 mL).6

Intralesional steroid injection is a great tool for quieting an active disease flare while simultaneously instating ongoing treatment for preventive management. However, even when disease control is optimized, patients may still experience intermittent flares of disease. For some patients, it may be appropriate to have a plan in place for a return to clinic during the beginning of a flare to obtain intralesional steroids. The ability to come in on short notice may help avoid visits to the emergency department and urgent care where your patients may receive treatments such as short courses of antibiotics or incision and drainage that may deviate from your overall treatment plan.

Consider Childbearing Status

Don’t forget to consider childbearing plans and childbearing potential when treating female patients with HS. Pregnancy is a frequent consideration in HS patients, as HS affects 3 to 4 times more women than men and typically presents after puberty (second or third decades of life). Many of the medications in the HS armamentarium are contraindicated in pregnancy including tetracyclines, retinoids, and hormonal agents. Surgery should be avoided in pregnant patients whenever possible, particularly in the first trimester. Relatively safe options include topical antibiotics such as clindamycin and metronidazole, as well as tumor necrosis factor α inhibitors, which are classified as category B in pregnancy.5

Before making treatment decisions in pregnant and breastfeeding patients, consult the US Food and Drug Administration recommendations. Perng et al7 reviewed current management strategies for HS in pregnant and breastfeeding women, and their review article in the Journal of the American Academy of Dermatology is an excellent resource.

Final Thoughts

Comprehensive management of HS may include a combination of medication and procedures, lifestyle modification, management of comorbidities, and social support. Formulating a good treatment plan may be a challenge but can drastically improve your patient’s quality of life.

References
  1. What is hidradenitis suppurativa? Hidradenitis Suppurativa Foundation website. https://www.hs-foundation.org/what-is-hs. Accessed October 9, 2019. 
  2. Frew JW, Hawkes JE, Krueger JG. Topical, systemic and biologic therapies in hidradenitis suppurativa: pathogenic insights by examining therapeutic mechanisms. Ther Adv Chronic Dis. 2019;10:2040622319830646. doi:10.1177/2040622319830646 
  3. Lacarrubba F, Musumeci ML, Nasca MR, et al. Double-ended pseudocomedones in hidradenitis suppurativa: clinical, dermoscopic, and histopathological correlation. Acta Derm Venereol. 2017;97:763-764. 
  4. Alikhan A, Sayed C, Alavi A, et al. North American Clinical Management Guidelines for Hidradenitis Suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. part I: diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019;81:76-90. 
  5. Alikhan A, Sayed C, Alavi A, et al. North American Clinical Management Guidelines for Hidradenitis Suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81:91-101. 
  6. Riis PT, Boer J, Prens EP, et al. Intralesional triamcinolone for flares of hidradenitis suppurativa (HS): a case series. J Am Acad Dermatol. 2016;75:1151-1155. 
  7. Perng P, Zampella JG, Okoye GA. Management of hidradenitis suppurativa in pregnancy. J Am Acad Dermatol. 2017;76:979-989.  
     
References
  1. What is hidradenitis suppurativa? Hidradenitis Suppurativa Foundation website. https://www.hs-foundation.org/what-is-hs. Accessed October 9, 2019. 
  2. Frew JW, Hawkes JE, Krueger JG. Topical, systemic and biologic therapies in hidradenitis suppurativa: pathogenic insights by examining therapeutic mechanisms. Ther Adv Chronic Dis. 2019;10:2040622319830646. doi:10.1177/2040622319830646 
  3. Lacarrubba F, Musumeci ML, Nasca MR, et al. Double-ended pseudocomedones in hidradenitis suppurativa: clinical, dermoscopic, and histopathological correlation. Acta Derm Venereol. 2017;97:763-764. 
  4. Alikhan A, Sayed C, Alavi A, et al. North American Clinical Management Guidelines for Hidradenitis Suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. part I: diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019;81:76-90. 
  5. Alikhan A, Sayed C, Alavi A, et al. North American Clinical Management Guidelines for Hidradenitis Suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81:91-101. 
  6. Riis PT, Boer J, Prens EP, et al. Intralesional triamcinolone for flares of hidradenitis suppurativa (HS): a case series. J Am Acad Dermatol. 2016;75:1151-1155. 
  7. Perng P, Zampella JG, Okoye GA. Management of hidradenitis suppurativa in pregnancy. J Am Acad Dermatol. 2017;76:979-989.  
     
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Resident Pearls

  • Medical treatment of hidradenitis suppurativa (HS) can be relatively straightforward, but optimal comprehensive management is multifaceted.
  • Educate patients about pathophysiology, counsel on smoking cessation, remember laser hair removal, consider an ongoing plan for addressing flares, and think about childbearing status when treating HS patients.
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Feigning alcohol withdrawal symptoms can render the CIWA-Ar scale useless

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Feigning alcohol withdrawal symptoms can render the CIWA-Ar scale useless

The Clinical Institute Withdrawal Assessment for Alcohol–Revised (CIWA-Ar) scale is a well-established protocol that attempts to measure the degree of alcohol and benzodiazepine withdrawal. The CIWA-Ar scale measures 10 domains and indexes the severity of withdrawal on a scale from 0 to 67; scores >8 are generally considered to be indicative of at least mild-to-moderate withdrawal, and scores >20 represent significant withdrawal.1 Despite its common use in many medical settings, the CIWA-Ar scale has been impugned as a less-than-reliable index of true alcohol withdrawal2 and has the potential for misuse among ordering physicians.3 In this case report, I describe a malingering patient who intentionally and successfully feigned symptoms of alcohol withdrawal, which demonstrates that the purposeful reproduction of symptoms measured by the CIWA-Ar scale can render the protocol clinically useless.

CASE REPORT

Mr. G, a 63-year-old African-American man, was admitted to the general medical floor with a chief complaint of alcohol withdrawal. He had a history of alcohol use disorder, severe, and unspecified depression. He said he had been drinking a gallon of wine plus “a fifth” of vodka every day for the past 1.5 months. More than 1 year ago, he had been admitted for alcohol withdrawal with subsequent delirium tremens, but he denied having any other psychiatric history.

In the emergency department, Mr. G was given IV lorazepam, 6 mg total, for alcohol withdrawal. He was reported to be “scoring” on the CIWA-Ar scale with apparently uncontrollable tremulousness, visual hallucinations, and confusion. His vitals were within normal limits, his mean corpuscular volume and lipase level were within normal limits, and the rest of his presentation was largely unremarkable.

Once admitted to the general medical floor, he continued to receive benzodiazepines for what was documented as severe alcohol withdrawal. When clinical staff were not in the room, the patient was observed to be resting comfortably without tremulousness. When the patient was seen by the psychiatry consultation service, he produced full body tremulousness with marked shoulder and hip thrusting. His account of how much he had been drinking contradicted the amount he reported to other teams in the hospital. When the consulting psychiatrist appeared unimpressed by his full body jerking, the patient abruptly pointed to the corner of the room and yelled “What is that?” when nothing was there. When the primary medical team suggested to the patient that his vitals were within normal limits and he did not appear to be in true alcohol withdrawal, the patient escalated the degree of his full body jerking.

Over the next few days, the patient routinely would tell clinical staff “I’m having DTs.” He also specifically requested lorazepam. After consultation, the medical and psychiatry teams determined the patient was feigning symptoms of alcohol withdrawal. The lorazepam was discontinued, and the patient was discharged home with outpatient psychiatric follow-up.

Limitations of the CIWA-Ar scale

The CIWA-Ar scale is intended to guide the need for medications, such as benzodiazepines, to help mitigate symptoms of alcohol withdrawal. Symptom-triggered benzodiazepine treatment has been shown to be superior to fixed-schedule dosing.4 However, symptom-triggered treatment is problematic in the setting of feigned symptoms.

Feigning symptoms measured by the CIWA-Ar scale

When psychiatrists and nurses calculate a CIWA-Ar score, they rely on both subjective accounts of a patient’s withdrawal severity as well as objective signs, such as vitals and a physical examination. Many of the elements included in the CIWA-Ar scale can be easily feigned (Table). Feigned alcohol withdrawal may fall into 2 categories: (1) the false reporting of subjective symptoms, and (2) the false portrayal of objective signs.

Continue to: The false reporting...

 

 

The false reporting of subjective symptoms can include the reported presence of nausea or vomiting, anxiety, tactile hallucinations, auditory hallucinations, headache or head fullness, and visual hallucinations. The false portrayal of objective signs can include the feigning of tremulousness, agitation, and confusion (eg, incorrectly answering orienting questions). In both categories, the simple presence of these signs or symptoms, whether falsely reported or falsely portrayed, would cause the patient to “score” on the CIWA-Ar scale.

Thus, the need to effectively rule out feigned symptoms is essential because inappropriate dosing of benzodiazepines can be dangerous, costly, and utilize limited hospital resources that could otherwise be diverted to a patient with a true medical or psychiatric illness. In these instances, it is crucial to pay close attention to vital signs because these are more reliable indices of withdrawal. A patient’s ability to purposefully feign symptoms of alcohol withdrawal highlights the limitations of the CIWA-Ar scale as a validated measure of alcohol withdrawal, and renders it effectively useless in the setting of either malingering or factitious disorder.

Resnick5 describes malingering as either pure malingering, partial malingering, or false imputation. Pure malingering refers to the feigning of a nonexistent disorder or illness. Partial malingering refers to the exaggeration of symptoms that are present, but to a lesser degree. False imputation refers to the attribution of symptoms from a separate disorder to one the patient knows is unrelated (eg, attributing chronic low back pain from a prior sports injury to a recent motor vehicle accident). In Mr. G’s case, he had multiple prior admissions for true, non-feigned alcohol withdrawal with subsequent delirium tremens. His knowledge of the signs and symptoms of alcohol withdrawal therefore helped him make calculated efforts to manipulate clinical staff in his quest to obtain benzodiazepines. Whether this was pure or partial malingering remained unclear because Mr. G’s true level of withdrawal could not be adequately assessed.

Potentially serious consequences

The CIWA-Ar scale is among the most widely used scales to determine the level of alcohol withdrawal and need for subsequent benzodiazepine treatment. However, its effective use is limited because it relies on subjective symptoms and objective signs that can be easily feigned or manipulated. In the setting of malingering or factitious disorder, when a patient is feigning symptoms of alcohol withdrawal, the CIWA-Ar scale may be rendered clinically useless. This can lead to dangerous iatrogenic adverse effects, lengthy and nontherapeutic hospital stays, and an increasing financial burden on health care systems.

References

1. Sullivan JT, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989;84(11):1353-1357.
2. Knight E, Lappalainen L. Clinical Institute Withdrawal Assessment for Alcohol–Revised might be an unreliable tool in the management of alcohol withdrawal. Can Fam Physician. 2017;63(9):691-695.
3. Hecksel KA, Bostwick JM, Jaeger TM, et al. Inappropriate use of symptom-triggered therapy for alcohol withdrawal in the general hospital. Mayo Clin Proc. 2008;83(3):274-279.
4. Daeppen JB, Gache P, Landry U, et al. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002;162(10):1117-1121.
5. Resnick PJ. The detection of malingered mental illness. Behav Sci Law. 1984;2(1):20-38.

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The Clinical Institute Withdrawal Assessment for Alcohol–Revised (CIWA-Ar) scale is a well-established protocol that attempts to measure the degree of alcohol and benzodiazepine withdrawal. The CIWA-Ar scale measures 10 domains and indexes the severity of withdrawal on a scale from 0 to 67; scores >8 are generally considered to be indicative of at least mild-to-moderate withdrawal, and scores >20 represent significant withdrawal.1 Despite its common use in many medical settings, the CIWA-Ar scale has been impugned as a less-than-reliable index of true alcohol withdrawal2 and has the potential for misuse among ordering physicians.3 In this case report, I describe a malingering patient who intentionally and successfully feigned symptoms of alcohol withdrawal, which demonstrates that the purposeful reproduction of symptoms measured by the CIWA-Ar scale can render the protocol clinically useless.

CASE REPORT

Mr. G, a 63-year-old African-American man, was admitted to the general medical floor with a chief complaint of alcohol withdrawal. He had a history of alcohol use disorder, severe, and unspecified depression. He said he had been drinking a gallon of wine plus “a fifth” of vodka every day for the past 1.5 months. More than 1 year ago, he had been admitted for alcohol withdrawal with subsequent delirium tremens, but he denied having any other psychiatric history.

In the emergency department, Mr. G was given IV lorazepam, 6 mg total, for alcohol withdrawal. He was reported to be “scoring” on the CIWA-Ar scale with apparently uncontrollable tremulousness, visual hallucinations, and confusion. His vitals were within normal limits, his mean corpuscular volume and lipase level were within normal limits, and the rest of his presentation was largely unremarkable.

Once admitted to the general medical floor, he continued to receive benzodiazepines for what was documented as severe alcohol withdrawal. When clinical staff were not in the room, the patient was observed to be resting comfortably without tremulousness. When the patient was seen by the psychiatry consultation service, he produced full body tremulousness with marked shoulder and hip thrusting. His account of how much he had been drinking contradicted the amount he reported to other teams in the hospital. When the consulting psychiatrist appeared unimpressed by his full body jerking, the patient abruptly pointed to the corner of the room and yelled “What is that?” when nothing was there. When the primary medical team suggested to the patient that his vitals were within normal limits and he did not appear to be in true alcohol withdrawal, the patient escalated the degree of his full body jerking.

Over the next few days, the patient routinely would tell clinical staff “I’m having DTs.” He also specifically requested lorazepam. After consultation, the medical and psychiatry teams determined the patient was feigning symptoms of alcohol withdrawal. The lorazepam was discontinued, and the patient was discharged home with outpatient psychiatric follow-up.

Limitations of the CIWA-Ar scale

The CIWA-Ar scale is intended to guide the need for medications, such as benzodiazepines, to help mitigate symptoms of alcohol withdrawal. Symptom-triggered benzodiazepine treatment has been shown to be superior to fixed-schedule dosing.4 However, symptom-triggered treatment is problematic in the setting of feigned symptoms.

Feigning symptoms measured by the CIWA-Ar scale

When psychiatrists and nurses calculate a CIWA-Ar score, they rely on both subjective accounts of a patient’s withdrawal severity as well as objective signs, such as vitals and a physical examination. Many of the elements included in the CIWA-Ar scale can be easily feigned (Table). Feigned alcohol withdrawal may fall into 2 categories: (1) the false reporting of subjective symptoms, and (2) the false portrayal of objective signs.

Continue to: The false reporting...

 

 

The false reporting of subjective symptoms can include the reported presence of nausea or vomiting, anxiety, tactile hallucinations, auditory hallucinations, headache or head fullness, and visual hallucinations. The false portrayal of objective signs can include the feigning of tremulousness, agitation, and confusion (eg, incorrectly answering orienting questions). In both categories, the simple presence of these signs or symptoms, whether falsely reported or falsely portrayed, would cause the patient to “score” on the CIWA-Ar scale.

Thus, the need to effectively rule out feigned symptoms is essential because inappropriate dosing of benzodiazepines can be dangerous, costly, and utilize limited hospital resources that could otherwise be diverted to a patient with a true medical or psychiatric illness. In these instances, it is crucial to pay close attention to vital signs because these are more reliable indices of withdrawal. A patient’s ability to purposefully feign symptoms of alcohol withdrawal highlights the limitations of the CIWA-Ar scale as a validated measure of alcohol withdrawal, and renders it effectively useless in the setting of either malingering or factitious disorder.

Resnick5 describes malingering as either pure malingering, partial malingering, or false imputation. Pure malingering refers to the feigning of a nonexistent disorder or illness. Partial malingering refers to the exaggeration of symptoms that are present, but to a lesser degree. False imputation refers to the attribution of symptoms from a separate disorder to one the patient knows is unrelated (eg, attributing chronic low back pain from a prior sports injury to a recent motor vehicle accident). In Mr. G’s case, he had multiple prior admissions for true, non-feigned alcohol withdrawal with subsequent delirium tremens. His knowledge of the signs and symptoms of alcohol withdrawal therefore helped him make calculated efforts to manipulate clinical staff in his quest to obtain benzodiazepines. Whether this was pure or partial malingering remained unclear because Mr. G’s true level of withdrawal could not be adequately assessed.

Potentially serious consequences

The CIWA-Ar scale is among the most widely used scales to determine the level of alcohol withdrawal and need for subsequent benzodiazepine treatment. However, its effective use is limited because it relies on subjective symptoms and objective signs that can be easily feigned or manipulated. In the setting of malingering or factitious disorder, when a patient is feigning symptoms of alcohol withdrawal, the CIWA-Ar scale may be rendered clinically useless. This can lead to dangerous iatrogenic adverse effects, lengthy and nontherapeutic hospital stays, and an increasing financial burden on health care systems.

The Clinical Institute Withdrawal Assessment for Alcohol–Revised (CIWA-Ar) scale is a well-established protocol that attempts to measure the degree of alcohol and benzodiazepine withdrawal. The CIWA-Ar scale measures 10 domains and indexes the severity of withdrawal on a scale from 0 to 67; scores >8 are generally considered to be indicative of at least mild-to-moderate withdrawal, and scores >20 represent significant withdrawal.1 Despite its common use in many medical settings, the CIWA-Ar scale has been impugned as a less-than-reliable index of true alcohol withdrawal2 and has the potential for misuse among ordering physicians.3 In this case report, I describe a malingering patient who intentionally and successfully feigned symptoms of alcohol withdrawal, which demonstrates that the purposeful reproduction of symptoms measured by the CIWA-Ar scale can render the protocol clinically useless.

CASE REPORT

Mr. G, a 63-year-old African-American man, was admitted to the general medical floor with a chief complaint of alcohol withdrawal. He had a history of alcohol use disorder, severe, and unspecified depression. He said he had been drinking a gallon of wine plus “a fifth” of vodka every day for the past 1.5 months. More than 1 year ago, he had been admitted for alcohol withdrawal with subsequent delirium tremens, but he denied having any other psychiatric history.

In the emergency department, Mr. G was given IV lorazepam, 6 mg total, for alcohol withdrawal. He was reported to be “scoring” on the CIWA-Ar scale with apparently uncontrollable tremulousness, visual hallucinations, and confusion. His vitals were within normal limits, his mean corpuscular volume and lipase level were within normal limits, and the rest of his presentation was largely unremarkable.

Once admitted to the general medical floor, he continued to receive benzodiazepines for what was documented as severe alcohol withdrawal. When clinical staff were not in the room, the patient was observed to be resting comfortably without tremulousness. When the patient was seen by the psychiatry consultation service, he produced full body tremulousness with marked shoulder and hip thrusting. His account of how much he had been drinking contradicted the amount he reported to other teams in the hospital. When the consulting psychiatrist appeared unimpressed by his full body jerking, the patient abruptly pointed to the corner of the room and yelled “What is that?” when nothing was there. When the primary medical team suggested to the patient that his vitals were within normal limits and he did not appear to be in true alcohol withdrawal, the patient escalated the degree of his full body jerking.

Over the next few days, the patient routinely would tell clinical staff “I’m having DTs.” He also specifically requested lorazepam. After consultation, the medical and psychiatry teams determined the patient was feigning symptoms of alcohol withdrawal. The lorazepam was discontinued, and the patient was discharged home with outpatient psychiatric follow-up.

Limitations of the CIWA-Ar scale

The CIWA-Ar scale is intended to guide the need for medications, such as benzodiazepines, to help mitigate symptoms of alcohol withdrawal. Symptom-triggered benzodiazepine treatment has been shown to be superior to fixed-schedule dosing.4 However, symptom-triggered treatment is problematic in the setting of feigned symptoms.

Feigning symptoms measured by the CIWA-Ar scale

When psychiatrists and nurses calculate a CIWA-Ar score, they rely on both subjective accounts of a patient’s withdrawal severity as well as objective signs, such as vitals and a physical examination. Many of the elements included in the CIWA-Ar scale can be easily feigned (Table). Feigned alcohol withdrawal may fall into 2 categories: (1) the false reporting of subjective symptoms, and (2) the false portrayal of objective signs.

Continue to: The false reporting...

 

 

The false reporting of subjective symptoms can include the reported presence of nausea or vomiting, anxiety, tactile hallucinations, auditory hallucinations, headache or head fullness, and visual hallucinations. The false portrayal of objective signs can include the feigning of tremulousness, agitation, and confusion (eg, incorrectly answering orienting questions). In both categories, the simple presence of these signs or symptoms, whether falsely reported or falsely portrayed, would cause the patient to “score” on the CIWA-Ar scale.

Thus, the need to effectively rule out feigned symptoms is essential because inappropriate dosing of benzodiazepines can be dangerous, costly, and utilize limited hospital resources that could otherwise be diverted to a patient with a true medical or psychiatric illness. In these instances, it is crucial to pay close attention to vital signs because these are more reliable indices of withdrawal. A patient’s ability to purposefully feign symptoms of alcohol withdrawal highlights the limitations of the CIWA-Ar scale as a validated measure of alcohol withdrawal, and renders it effectively useless in the setting of either malingering or factitious disorder.

Resnick5 describes malingering as either pure malingering, partial malingering, or false imputation. Pure malingering refers to the feigning of a nonexistent disorder or illness. Partial malingering refers to the exaggeration of symptoms that are present, but to a lesser degree. False imputation refers to the attribution of symptoms from a separate disorder to one the patient knows is unrelated (eg, attributing chronic low back pain from a prior sports injury to a recent motor vehicle accident). In Mr. G’s case, he had multiple prior admissions for true, non-feigned alcohol withdrawal with subsequent delirium tremens. His knowledge of the signs and symptoms of alcohol withdrawal therefore helped him make calculated efforts to manipulate clinical staff in his quest to obtain benzodiazepines. Whether this was pure or partial malingering remained unclear because Mr. G’s true level of withdrawal could not be adequately assessed.

Potentially serious consequences

The CIWA-Ar scale is among the most widely used scales to determine the level of alcohol withdrawal and need for subsequent benzodiazepine treatment. However, its effective use is limited because it relies on subjective symptoms and objective signs that can be easily feigned or manipulated. In the setting of malingering or factitious disorder, when a patient is feigning symptoms of alcohol withdrawal, the CIWA-Ar scale may be rendered clinically useless. This can lead to dangerous iatrogenic adverse effects, lengthy and nontherapeutic hospital stays, and an increasing financial burden on health care systems.

References

1. Sullivan JT, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989;84(11):1353-1357.
2. Knight E, Lappalainen L. Clinical Institute Withdrawal Assessment for Alcohol–Revised might be an unreliable tool in the management of alcohol withdrawal. Can Fam Physician. 2017;63(9):691-695.
3. Hecksel KA, Bostwick JM, Jaeger TM, et al. Inappropriate use of symptom-triggered therapy for alcohol withdrawal in the general hospital. Mayo Clin Proc. 2008;83(3):274-279.
4. Daeppen JB, Gache P, Landry U, et al. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002;162(10):1117-1121.
5. Resnick PJ. The detection of malingered mental illness. Behav Sci Law. 1984;2(1):20-38.

References

1. Sullivan JT, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989;84(11):1353-1357.
2. Knight E, Lappalainen L. Clinical Institute Withdrawal Assessment for Alcohol–Revised might be an unreliable tool in the management of alcohol withdrawal. Can Fam Physician. 2017;63(9):691-695.
3. Hecksel KA, Bostwick JM, Jaeger TM, et al. Inappropriate use of symptom-triggered therapy for alcohol withdrawal in the general hospital. Mayo Clin Proc. 2008;83(3):274-279.
4. Daeppen JB, Gache P, Landry U, et al. Symptom-triggered vs fixed-schedule doses of benzodiazepine for alcohol withdrawal: a randomized treatment trial. Arch Intern Med. 2002;162(10):1117-1121.
5. Resnick PJ. The detection of malingered mental illness. Behav Sci Law. 1984;2(1):20-38.

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OTC hormonal contraception: An important goal in the fight for reproductive justice

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Changed
Thu, 01/09/2020 - 15:53

A new American College of Obstetricians and Gynecologists (ACOG) committee opinion addresses how contraception access can be improved through over-the-counter (OTC) hormonal contraception for people of all ages—including oral contraceptive pills (OCPs), progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate (DMPA). Although ACOG endorses OTC contraception, some health care providers may be hesitant to support the increase in accessibility for a variety of reasons. We are hopeful that we address these concerns and that all clinicians can move to support ACOG’s position.

Easing access to hormonal contraception is a first step

OCPs are the most widely used contraception among teens and women of reproductive age in the United States.1 Although the Affordable Care Act (ACA) mandated health insurance coverage for contraception, many barriers continue to exist, including obtaining a prescription. Only 13 states have made it legal to obtain hormonal contraception through a pharmacist.2 There also has been an increase in the number of telemedicine and online services that deliver contraceptives to individuals’ homes. While these efforts have helped to decrease barriers to hormonal contraception access for some patients, they only reach a small segment of the population. As clinicians, we should strive to make contraception universally accessible and affordable to everyone who desires to use it. OTC provision can bring us closer to this goal.

Addressing the misconceptions about contraception

Adverse events with hormonal contraception are rarer than one may think. There are few risks associated with hormonal contraception. Venous thromboembolus (VTE) is a serious, although rare, adverse effect (AE) of hormonal contraception. The rate of VTE with combined oral contraception is estimated at 3 to 8 events per 10,000 patient-years, and VTE is even less common with progestin-only contraception (1 to 5 per 10,000 patient-years). For both types of hormonal contraception, the risk of VTE is smaller than with pregnancy, which is 5 to 20 per 10,000 patient-years.3 There are comorbidities that increase the risk of VTE and other AEs of hormonal contraception. In the setting of OTC hormonal contraception, individuals would self-screen for contraindications in order to reduce these complications.

Patients have the aptitude to self-screen for contraindications. Studies looking at the ability of patients over the age of 18 to self-screen for contraindications to hormonal contraception have found that patients do appropriately screen themselves. In fact, they are often more conservative than a physician in avoiding hormonal contraceptive methods.4 Patients younger than age 18 rarely have contraindications to hormonal contraception, but limited studies have shown that they too are able to successfully self-screen.5 ACOG recommends self-screening tools be provided with all OTC combined hormonal contraceptive methods to aid an individual’s contraceptive choice.

Most patients continue their well person care. Some opponents to ACOG’s position also have expressed concern that people who access their contraception OTC will forego their annual exam with their provider. However, studies have shown that the majority of people will continue to make their preventative health care visits.6,7

 

 

We need to invest in preventing unplanned pregnancy

Currently, hormonal contraception is covered by health insurance under the ACA, with some caveats. Without a prescription, patients may have to pay full price for their contraception. However, one can find generic OCPs for less than $10 per pack out of pocket. Any cost can be prohibitive to many patients; thus, transition to OTC access to contraception also should ensure limiting the cost to the patient. One possible solution to mitigate costs is to require insurance companies to cover the cost of OTC hormonal contraceptives. (See action item below.)

Reduction in unplanned pregnancies improves public health and public expense, and broadening access to effective forms of contraception is imperative in reducing unplanned pregnancies. Every $1 invested in contraception access realizes $7.09 in savings.8 By making hormonal contraception widely available OTC, access could be improved dramatically—although pharmacist provision of hormonal contraception may be a necessary intermediate step. ACOG’s most recent committee opinion encourages all reproductive health care providers to be strong advocates for this improvement in access. As women’s health providers, we should work to decrease access barriers for our patients; working toward OTC contraception is a critical step in equal access to birth control methods for all of our patients.

Action items

Remember, before a pill can move to OTC access, the manufacturing (pharmaceutical) company must submit an application to the US Food and Drug Administration to obtain this status. Once submitted, the process may take 3 to 4 years to be completed. Currently, no company has submitted an OTC application and no hormonal birth control is available OTC. Find resources for OTC birth control access here: http://ocsotc.org/ and www.freethepill.org.

  • Talk to your state representatives about why both OTC birth control access and direct pharmacy availability are important to increasing access and decreasing disparities in reproductive health care. Find your local and federal representatives here and check the status of OCP access in your state here.
  • Representative Ayanna Pressley (D-MA) and Senator Patty Murray (D-WA) both have introduced legislation—the Affordability is Access Act (HR 3296/S1847)—to ensure insurance coverage for OTC contraception. Call your representative and ask them to cosponsor this legislation.
  • Be mindful of legislation that promotes OTC OCPs but limits access to some populations (minors) and increases cost sharing to the patient. This type of legislation can create harmful barriers to access for some of our patients
References
  1. Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Rep. 2012;(60):1-25.
  2.  Free the pill. What’s the law in your state? Ibis Reproductive Health website. http://freethepill.org/statepolicies. Accessed November 15, 2019.
  3. U.S. Food and Drug Administration. FDA Drug Safety Communication: updated information about the risk of blood clots in women taking birth control pills containing drospirenone. https://www.fda.gov/Drugs/DrugSafety/ucm299305.htm. Accessed November 15, 2019.
  4. Grossman D, Fernandez L, Hopkins K, et al. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112:572e8.
  5. Williams R, Hensel D, Lehmann A, et al. Adolescent self-screening for contraindications to combined oral contraceptive pills [abstract]. Contraception. 2015;92:380.
  6. Hopkins K, Grossman D, White K, et al. Reproductive health preventive screening among clinic vs. over-the-counter oral contraceptive users. Contraception. 2012;86:376-382.
  7. Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Womens Health Issues. 2018;28:144-151.
  8. Frost JJ, Sonfield A, Zolna MR, et al. Return on investment: a fuller assessment of the benefits and cost savings of the US publicly funded family planning program. Milbank Q. 2014;92:696-749.
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Dr. Evans is Assistant Professor, Tufts University School of Medicine, and Associate Program Director, Department of Obstetrics and Gynecology, Tufts Medical Center.

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Dr. Evans is Assistant Professor, Tufts University School of Medicine, and Associate Program Director, Department of Obstetrics and Gynecology, Tufts Medical Center.

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A new American College of Obstetricians and Gynecologists (ACOG) committee opinion addresses how contraception access can be improved through over-the-counter (OTC) hormonal contraception for people of all ages—including oral contraceptive pills (OCPs), progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate (DMPA). Although ACOG endorses OTC contraception, some health care providers may be hesitant to support the increase in accessibility for a variety of reasons. We are hopeful that we address these concerns and that all clinicians can move to support ACOG’s position.

Easing access to hormonal contraception is a first step

OCPs are the most widely used contraception among teens and women of reproductive age in the United States.1 Although the Affordable Care Act (ACA) mandated health insurance coverage for contraception, many barriers continue to exist, including obtaining a prescription. Only 13 states have made it legal to obtain hormonal contraception through a pharmacist.2 There also has been an increase in the number of telemedicine and online services that deliver contraceptives to individuals’ homes. While these efforts have helped to decrease barriers to hormonal contraception access for some patients, they only reach a small segment of the population. As clinicians, we should strive to make contraception universally accessible and affordable to everyone who desires to use it. OTC provision can bring us closer to this goal.

Addressing the misconceptions about contraception

Adverse events with hormonal contraception are rarer than one may think. There are few risks associated with hormonal contraception. Venous thromboembolus (VTE) is a serious, although rare, adverse effect (AE) of hormonal contraception. The rate of VTE with combined oral contraception is estimated at 3 to 8 events per 10,000 patient-years, and VTE is even less common with progestin-only contraception (1 to 5 per 10,000 patient-years). For both types of hormonal contraception, the risk of VTE is smaller than with pregnancy, which is 5 to 20 per 10,000 patient-years.3 There are comorbidities that increase the risk of VTE and other AEs of hormonal contraception. In the setting of OTC hormonal contraception, individuals would self-screen for contraindications in order to reduce these complications.

Patients have the aptitude to self-screen for contraindications. Studies looking at the ability of patients over the age of 18 to self-screen for contraindications to hormonal contraception have found that patients do appropriately screen themselves. In fact, they are often more conservative than a physician in avoiding hormonal contraceptive methods.4 Patients younger than age 18 rarely have contraindications to hormonal contraception, but limited studies have shown that they too are able to successfully self-screen.5 ACOG recommends self-screening tools be provided with all OTC combined hormonal contraceptive methods to aid an individual’s contraceptive choice.

Most patients continue their well person care. Some opponents to ACOG’s position also have expressed concern that people who access their contraception OTC will forego their annual exam with their provider. However, studies have shown that the majority of people will continue to make their preventative health care visits.6,7

 

 

We need to invest in preventing unplanned pregnancy

Currently, hormonal contraception is covered by health insurance under the ACA, with some caveats. Without a prescription, patients may have to pay full price for their contraception. However, one can find generic OCPs for less than $10 per pack out of pocket. Any cost can be prohibitive to many patients; thus, transition to OTC access to contraception also should ensure limiting the cost to the patient. One possible solution to mitigate costs is to require insurance companies to cover the cost of OTC hormonal contraceptives. (See action item below.)

Reduction in unplanned pregnancies improves public health and public expense, and broadening access to effective forms of contraception is imperative in reducing unplanned pregnancies. Every $1 invested in contraception access realizes $7.09 in savings.8 By making hormonal contraception widely available OTC, access could be improved dramatically—although pharmacist provision of hormonal contraception may be a necessary intermediate step. ACOG’s most recent committee opinion encourages all reproductive health care providers to be strong advocates for this improvement in access. As women’s health providers, we should work to decrease access barriers for our patients; working toward OTC contraception is a critical step in equal access to birth control methods for all of our patients.

Action items

Remember, before a pill can move to OTC access, the manufacturing (pharmaceutical) company must submit an application to the US Food and Drug Administration to obtain this status. Once submitted, the process may take 3 to 4 years to be completed. Currently, no company has submitted an OTC application and no hormonal birth control is available OTC. Find resources for OTC birth control access here: http://ocsotc.org/ and www.freethepill.org.

  • Talk to your state representatives about why both OTC birth control access and direct pharmacy availability are important to increasing access and decreasing disparities in reproductive health care. Find your local and federal representatives here and check the status of OCP access in your state here.
  • Representative Ayanna Pressley (D-MA) and Senator Patty Murray (D-WA) both have introduced legislation—the Affordability is Access Act (HR 3296/S1847)—to ensure insurance coverage for OTC contraception. Call your representative and ask them to cosponsor this legislation.
  • Be mindful of legislation that promotes OTC OCPs but limits access to some populations (minors) and increases cost sharing to the patient. This type of legislation can create harmful barriers to access for some of our patients

A new American College of Obstetricians and Gynecologists (ACOG) committee opinion addresses how contraception access can be improved through over-the-counter (OTC) hormonal contraception for people of all ages—including oral contraceptive pills (OCPs), progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate (DMPA). Although ACOG endorses OTC contraception, some health care providers may be hesitant to support the increase in accessibility for a variety of reasons. We are hopeful that we address these concerns and that all clinicians can move to support ACOG’s position.

Easing access to hormonal contraception is a first step

OCPs are the most widely used contraception among teens and women of reproductive age in the United States.1 Although the Affordable Care Act (ACA) mandated health insurance coverage for contraception, many barriers continue to exist, including obtaining a prescription. Only 13 states have made it legal to obtain hormonal contraception through a pharmacist.2 There also has been an increase in the number of telemedicine and online services that deliver contraceptives to individuals’ homes. While these efforts have helped to decrease barriers to hormonal contraception access for some patients, they only reach a small segment of the population. As clinicians, we should strive to make contraception universally accessible and affordable to everyone who desires to use it. OTC provision can bring us closer to this goal.

Addressing the misconceptions about contraception

Adverse events with hormonal contraception are rarer than one may think. There are few risks associated with hormonal contraception. Venous thromboembolus (VTE) is a serious, although rare, adverse effect (AE) of hormonal contraception. The rate of VTE with combined oral contraception is estimated at 3 to 8 events per 10,000 patient-years, and VTE is even less common with progestin-only contraception (1 to 5 per 10,000 patient-years). For both types of hormonal contraception, the risk of VTE is smaller than with pregnancy, which is 5 to 20 per 10,000 patient-years.3 There are comorbidities that increase the risk of VTE and other AEs of hormonal contraception. In the setting of OTC hormonal contraception, individuals would self-screen for contraindications in order to reduce these complications.

Patients have the aptitude to self-screen for contraindications. Studies looking at the ability of patients over the age of 18 to self-screen for contraindications to hormonal contraception have found that patients do appropriately screen themselves. In fact, they are often more conservative than a physician in avoiding hormonal contraceptive methods.4 Patients younger than age 18 rarely have contraindications to hormonal contraception, but limited studies have shown that they too are able to successfully self-screen.5 ACOG recommends self-screening tools be provided with all OTC combined hormonal contraceptive methods to aid an individual’s contraceptive choice.

Most patients continue their well person care. Some opponents to ACOG’s position also have expressed concern that people who access their contraception OTC will forego their annual exam with their provider. However, studies have shown that the majority of people will continue to make their preventative health care visits.6,7

 

 

We need to invest in preventing unplanned pregnancy

Currently, hormonal contraception is covered by health insurance under the ACA, with some caveats. Without a prescription, patients may have to pay full price for their contraception. However, one can find generic OCPs for less than $10 per pack out of pocket. Any cost can be prohibitive to many patients; thus, transition to OTC access to contraception also should ensure limiting the cost to the patient. One possible solution to mitigate costs is to require insurance companies to cover the cost of OTC hormonal contraceptives. (See action item below.)

Reduction in unplanned pregnancies improves public health and public expense, and broadening access to effective forms of contraception is imperative in reducing unplanned pregnancies. Every $1 invested in contraception access realizes $7.09 in savings.8 By making hormonal contraception widely available OTC, access could be improved dramatically—although pharmacist provision of hormonal contraception may be a necessary intermediate step. ACOG’s most recent committee opinion encourages all reproductive health care providers to be strong advocates for this improvement in access. As women’s health providers, we should work to decrease access barriers for our patients; working toward OTC contraception is a critical step in equal access to birth control methods for all of our patients.

Action items

Remember, before a pill can move to OTC access, the manufacturing (pharmaceutical) company must submit an application to the US Food and Drug Administration to obtain this status. Once submitted, the process may take 3 to 4 years to be completed. Currently, no company has submitted an OTC application and no hormonal birth control is available OTC. Find resources for OTC birth control access here: http://ocsotc.org/ and www.freethepill.org.

  • Talk to your state representatives about why both OTC birth control access and direct pharmacy availability are important to increasing access and decreasing disparities in reproductive health care. Find your local and federal representatives here and check the status of OCP access in your state here.
  • Representative Ayanna Pressley (D-MA) and Senator Patty Murray (D-WA) both have introduced legislation—the Affordability is Access Act (HR 3296/S1847)—to ensure insurance coverage for OTC contraception. Call your representative and ask them to cosponsor this legislation.
  • Be mindful of legislation that promotes OTC OCPs but limits access to some populations (minors) and increases cost sharing to the patient. This type of legislation can create harmful barriers to access for some of our patients
References
  1. Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Rep. 2012;(60):1-25.
  2.  Free the pill. What’s the law in your state? Ibis Reproductive Health website. http://freethepill.org/statepolicies. Accessed November 15, 2019.
  3. U.S. Food and Drug Administration. FDA Drug Safety Communication: updated information about the risk of blood clots in women taking birth control pills containing drospirenone. https://www.fda.gov/Drugs/DrugSafety/ucm299305.htm. Accessed November 15, 2019.
  4. Grossman D, Fernandez L, Hopkins K, et al. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112:572e8.
  5. Williams R, Hensel D, Lehmann A, et al. Adolescent self-screening for contraindications to combined oral contraceptive pills [abstract]. Contraception. 2015;92:380.
  6. Hopkins K, Grossman D, White K, et al. Reproductive health preventive screening among clinic vs. over-the-counter oral contraceptive users. Contraception. 2012;86:376-382.
  7. Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Womens Health Issues. 2018;28:144-151.
  8. Frost JJ, Sonfield A, Zolna MR, et al. Return on investment: a fuller assessment of the benefits and cost savings of the US publicly funded family planning program. Milbank Q. 2014;92:696-749.
References
  1. Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Rep. 2012;(60):1-25.
  2.  Free the pill. What’s the law in your state? Ibis Reproductive Health website. http://freethepill.org/statepolicies. Accessed November 15, 2019.
  3. U.S. Food and Drug Administration. FDA Drug Safety Communication: updated information about the risk of blood clots in women taking birth control pills containing drospirenone. https://www.fda.gov/Drugs/DrugSafety/ucm299305.htm. Accessed November 15, 2019.
  4. Grossman D, Fernandez L, Hopkins K, et al. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112:572e8.
  5. Williams R, Hensel D, Lehmann A, et al. Adolescent self-screening for contraindications to combined oral contraceptive pills [abstract]. Contraception. 2015;92:380.
  6. Hopkins K, Grossman D, White K, et al. Reproductive health preventive screening among clinic vs. over-the-counter oral contraceptive users. Contraception. 2012;86:376-382.
  7. Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Womens Health Issues. 2018;28:144-151.
  8. Frost JJ, Sonfield A, Zolna MR, et al. Return on investment: a fuller assessment of the benefits and cost savings of the US publicly funded family planning program. Milbank Q. 2014;92:696-749.
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OBG Management - 32(1)
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OBG Management - 32(1)
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