U.S. biosimilar competition, use, and availability still lags behind European countries

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The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.

Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.

As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.

“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.

To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.

They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.



Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.

On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.

The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.

However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.

Looking ahead, “Policies for drug pricing negotiations in the U.S. against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access,” they concluded.

The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.

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The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.

Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.

As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.

“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.

To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.

They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.



Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.

On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.

The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.

However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.

Looking ahead, “Policies for drug pricing negotiations in the U.S. against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access,” they concluded.

The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.

The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.

Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.

As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.

“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.

To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.

They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.



Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.

On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.

The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.

However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.

Looking ahead, “Policies for drug pricing negotiations in the U.S. against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access,” they concluded.

The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.

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How to Foster Camaraderie in Dermatology Residency

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Change is inevitable in residency as well as in life. Every year on July 1, the atmosphere and social structure of residencies change with the new postgraduate year 2 class. Each class brings a unique perspective and energy. Residents come together from different backgrounds and life situations. Some residents are single, some are engaged or married, and some are starting or expanding their families. Some residents will have prior careers, others will have graduate degrees or expertise in various fields. They will have different ethnic backgrounds, religious and/or spiritual beliefs, familial upbringings, personalities, and methods of communicating. These differences all are important to consider when developing a mindset of inclusion and camaraderie. As residents start their journey together, it is important to remember that residency is a team endeavor. The principles of teamwork apply directly to residents and are founded on creating a climate of trust and building strong relationships with one another.1 Trust is the foundation of good relationships in the workplace; it allows people to communicate freely and foster the belief that everyone is working for each other’s best interests. Being open and sharing knowledge about networking opportunities, scholarships, and research projects is one way to foster collaboration and trust in residency.

Diversity, equity, and inclusion in dermatology is a work in progress. In the 2020-2021 dermatology application cycle, only 4.8% of applicants identified as Hispanic or Latino, and 7.8% identified as Black or African American.2 The American Academy of Dermatology took an active role in promoting diversity by creating a task force in 2018 to increase the exposure and recruitment into dermatology of medical students who are underrepresented in medicine.2 As standards for diversity are met in dermatology, we will have the wonderful opportunity to welcome even more diversity into our lives.

Listening, showing curiosity about your co-residents’ lives outside of work, and asking questions can help build respect, friendships, and camaraderie. Ask your co-residents what makes them happy and what their goals are in residency. Finding common goals and cultivating the mindset that you all work together to achieve your goals is key to the success of a residency class. Now that we discussed accepting and welcoming differences, how do you foster camaraderie in a social setting?

Establish a Social Committee

As a class, consider 1 or 2 residents who are always excited to try new activities such as attend restaurant openings, exercise classes, concerts, or movie nights. Consider nominating these co-residents along with one attending to be social chairs of your residency. The social chairs should meet and establish at least 1 social event per season, with 4 total for the academic year. There are only 2 rules with social events: (1) they must be held outside of clinic, and (2) everyone should try their best to attend.

Social chairs should try to prioritize a location-specific event that allows the residents who are not from the area to experience something local, which can be anything from apple picking at an orchard in the fall to beach volleyball in the summer. Planning these parties gives everyone an event to look forward to and a chance to spend time together and grow closer. The memories and inside jokes that arise from these outings are invaluable and increase joy inside and outside of clinic.

Utilize Social Media

Another project can be developing a social media account for your program with the approval of your faculty. @unmcdermatology, @uwderm, and @gwdermres can help foster social relationships by establishing a lighthearted space to celebrate the residency’s achievements, new publications, volunteer events, or social gatherings.

Encourage Local and National Conference Attendance

All residents should be encouraged to submit abstracts to local and national conferences and attend with their co-residents. Conferences are peak opportunities to foster camaraderie within residency classes, as they involve a sense of togetherness in the specialty along with the excitement of traveling to a new city and meeting other like-minded individuals. Conferences allow collaboration within the specialty on a national level and foster relationships between residency programs.

 

 

In addition, national groups such as the Women’s Dermatologic Society, the Skin of Color Society, and the American Academy of Dermatology Diversity, Equity, and Inclusion task force meet at the national conferences and discuss their next initiatives and projects. Joining a society of your interest can lead to many new networks and relationships you may not have had before. Even if you are not interested in specializing after general dermatology, consider attending a surgery, dermatopathology, or pediatric or cosmetic dermatology conference to learn more about the field from the experts.

Repair Conflicts and Build a Climate of Collaboration

Conflicts and disagreements unfortunately are inevitable during residency. Whether they involve planning vacation times or coordinating call schedules, everyone will not agree on every decision. Learning how to handle and approach conflict with co-residents is of utmost importance to maintaining the hard work you have put in to create trust, camaraderie, and a good social atmosphere. If you are having an issue with a circumstance involving a co-resident, holding a grudge will only sour your experience and the experience of others. Talking to your co-resident directly about your concerns before escalating the issue to a chief resident or faculty member is a great start. Consider asking them about their thought process and show concern for their point of view. Listen to them openly before going into your preferences. It is important to remember that working as a team requires sacrifices, and sometimes you will not be satisfied with the outcome of a conflict.

It also is important to remember that feelings change, and an issue you feel you must address immediately can wait to be addressed at a better time when you have calmed down. You may even find that you decide not to address it at all. At the end of the day, if a conflict cannot be worked out between those involved, consider confiding in a chief resident or a faculty mentor for advice on the next steps to take to resolve the problem. Ultimately, having a good foundation of respect and strong bonds with your residents will help tremendously when conflicts arise.

Final Thoughts

Fostering camaraderie in residency will improve the overall experience and lives of the residents, as well as the experience of the faculty, staff, and patients by the trickle-down effect. Creating a cheerful and fun atmosphere filled with inside jokes and excitement regarding upcoming social events or conferences will certainly result in a time you will cherish for the rest of your life.

References
  1. Kouzes JM, Posner BZ. Foster collaboration. In: Kouzes JM, Posner BZ, eds. The Leadership Challenge. 6th ed. John Wiley & Sons, Inc; 2017:195-217.
  2. Cooper J, Shao K, Feng H. Racial/ethnic health disparities in dermatology in the United States, part 1: overview of contributing factors and management strategies [published online February 7, 2022]. J Am Acad Dermatol. 2022;87:723-730. doi:10.1016/j.jaad.2021.12.061
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Correspondence: Sonali Nanda, MD ([email protected]).

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The author reports no conflict of interest.

Correspondence: Sonali Nanda, MD ([email protected]).

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Change is inevitable in residency as well as in life. Every year on July 1, the atmosphere and social structure of residencies change with the new postgraduate year 2 class. Each class brings a unique perspective and energy. Residents come together from different backgrounds and life situations. Some residents are single, some are engaged or married, and some are starting or expanding their families. Some residents will have prior careers, others will have graduate degrees or expertise in various fields. They will have different ethnic backgrounds, religious and/or spiritual beliefs, familial upbringings, personalities, and methods of communicating. These differences all are important to consider when developing a mindset of inclusion and camaraderie. As residents start their journey together, it is important to remember that residency is a team endeavor. The principles of teamwork apply directly to residents and are founded on creating a climate of trust and building strong relationships with one another.1 Trust is the foundation of good relationships in the workplace; it allows people to communicate freely and foster the belief that everyone is working for each other’s best interests. Being open and sharing knowledge about networking opportunities, scholarships, and research projects is one way to foster collaboration and trust in residency.

Diversity, equity, and inclusion in dermatology is a work in progress. In the 2020-2021 dermatology application cycle, only 4.8% of applicants identified as Hispanic or Latino, and 7.8% identified as Black or African American.2 The American Academy of Dermatology took an active role in promoting diversity by creating a task force in 2018 to increase the exposure and recruitment into dermatology of medical students who are underrepresented in medicine.2 As standards for diversity are met in dermatology, we will have the wonderful opportunity to welcome even more diversity into our lives.

Listening, showing curiosity about your co-residents’ lives outside of work, and asking questions can help build respect, friendships, and camaraderie. Ask your co-residents what makes them happy and what their goals are in residency. Finding common goals and cultivating the mindset that you all work together to achieve your goals is key to the success of a residency class. Now that we discussed accepting and welcoming differences, how do you foster camaraderie in a social setting?

Establish a Social Committee

As a class, consider 1 or 2 residents who are always excited to try new activities such as attend restaurant openings, exercise classes, concerts, or movie nights. Consider nominating these co-residents along with one attending to be social chairs of your residency. The social chairs should meet and establish at least 1 social event per season, with 4 total for the academic year. There are only 2 rules with social events: (1) they must be held outside of clinic, and (2) everyone should try their best to attend.

Social chairs should try to prioritize a location-specific event that allows the residents who are not from the area to experience something local, which can be anything from apple picking at an orchard in the fall to beach volleyball in the summer. Planning these parties gives everyone an event to look forward to and a chance to spend time together and grow closer. The memories and inside jokes that arise from these outings are invaluable and increase joy inside and outside of clinic.

Utilize Social Media

Another project can be developing a social media account for your program with the approval of your faculty. @unmcdermatology, @uwderm, and @gwdermres can help foster social relationships by establishing a lighthearted space to celebrate the residency’s achievements, new publications, volunteer events, or social gatherings.

Encourage Local and National Conference Attendance

All residents should be encouraged to submit abstracts to local and national conferences and attend with their co-residents. Conferences are peak opportunities to foster camaraderie within residency classes, as they involve a sense of togetherness in the specialty along with the excitement of traveling to a new city and meeting other like-minded individuals. Conferences allow collaboration within the specialty on a national level and foster relationships between residency programs.

 

 

In addition, national groups such as the Women’s Dermatologic Society, the Skin of Color Society, and the American Academy of Dermatology Diversity, Equity, and Inclusion task force meet at the national conferences and discuss their next initiatives and projects. Joining a society of your interest can lead to many new networks and relationships you may not have had before. Even if you are not interested in specializing after general dermatology, consider attending a surgery, dermatopathology, or pediatric or cosmetic dermatology conference to learn more about the field from the experts.

Repair Conflicts and Build a Climate of Collaboration

Conflicts and disagreements unfortunately are inevitable during residency. Whether they involve planning vacation times or coordinating call schedules, everyone will not agree on every decision. Learning how to handle and approach conflict with co-residents is of utmost importance to maintaining the hard work you have put in to create trust, camaraderie, and a good social atmosphere. If you are having an issue with a circumstance involving a co-resident, holding a grudge will only sour your experience and the experience of others. Talking to your co-resident directly about your concerns before escalating the issue to a chief resident or faculty member is a great start. Consider asking them about their thought process and show concern for their point of view. Listen to them openly before going into your preferences. It is important to remember that working as a team requires sacrifices, and sometimes you will not be satisfied with the outcome of a conflict.

It also is important to remember that feelings change, and an issue you feel you must address immediately can wait to be addressed at a better time when you have calmed down. You may even find that you decide not to address it at all. At the end of the day, if a conflict cannot be worked out between those involved, consider confiding in a chief resident or a faculty mentor for advice on the next steps to take to resolve the problem. Ultimately, having a good foundation of respect and strong bonds with your residents will help tremendously when conflicts arise.

Final Thoughts

Fostering camaraderie in residency will improve the overall experience and lives of the residents, as well as the experience of the faculty, staff, and patients by the trickle-down effect. Creating a cheerful and fun atmosphere filled with inside jokes and excitement regarding upcoming social events or conferences will certainly result in a time you will cherish for the rest of your life.

Change is inevitable in residency as well as in life. Every year on July 1, the atmosphere and social structure of residencies change with the new postgraduate year 2 class. Each class brings a unique perspective and energy. Residents come together from different backgrounds and life situations. Some residents are single, some are engaged or married, and some are starting or expanding their families. Some residents will have prior careers, others will have graduate degrees or expertise in various fields. They will have different ethnic backgrounds, religious and/or spiritual beliefs, familial upbringings, personalities, and methods of communicating. These differences all are important to consider when developing a mindset of inclusion and camaraderie. As residents start their journey together, it is important to remember that residency is a team endeavor. The principles of teamwork apply directly to residents and are founded on creating a climate of trust and building strong relationships with one another.1 Trust is the foundation of good relationships in the workplace; it allows people to communicate freely and foster the belief that everyone is working for each other’s best interests. Being open and sharing knowledge about networking opportunities, scholarships, and research projects is one way to foster collaboration and trust in residency.

Diversity, equity, and inclusion in dermatology is a work in progress. In the 2020-2021 dermatology application cycle, only 4.8% of applicants identified as Hispanic or Latino, and 7.8% identified as Black or African American.2 The American Academy of Dermatology took an active role in promoting diversity by creating a task force in 2018 to increase the exposure and recruitment into dermatology of medical students who are underrepresented in medicine.2 As standards for diversity are met in dermatology, we will have the wonderful opportunity to welcome even more diversity into our lives.

Listening, showing curiosity about your co-residents’ lives outside of work, and asking questions can help build respect, friendships, and camaraderie. Ask your co-residents what makes them happy and what their goals are in residency. Finding common goals and cultivating the mindset that you all work together to achieve your goals is key to the success of a residency class. Now that we discussed accepting and welcoming differences, how do you foster camaraderie in a social setting?

Establish a Social Committee

As a class, consider 1 or 2 residents who are always excited to try new activities such as attend restaurant openings, exercise classes, concerts, or movie nights. Consider nominating these co-residents along with one attending to be social chairs of your residency. The social chairs should meet and establish at least 1 social event per season, with 4 total for the academic year. There are only 2 rules with social events: (1) they must be held outside of clinic, and (2) everyone should try their best to attend.

Social chairs should try to prioritize a location-specific event that allows the residents who are not from the area to experience something local, which can be anything from apple picking at an orchard in the fall to beach volleyball in the summer. Planning these parties gives everyone an event to look forward to and a chance to spend time together and grow closer. The memories and inside jokes that arise from these outings are invaluable and increase joy inside and outside of clinic.

Utilize Social Media

Another project can be developing a social media account for your program with the approval of your faculty. @unmcdermatology, @uwderm, and @gwdermres can help foster social relationships by establishing a lighthearted space to celebrate the residency’s achievements, new publications, volunteer events, or social gatherings.

Encourage Local and National Conference Attendance

All residents should be encouraged to submit abstracts to local and national conferences and attend with their co-residents. Conferences are peak opportunities to foster camaraderie within residency classes, as they involve a sense of togetherness in the specialty along with the excitement of traveling to a new city and meeting other like-minded individuals. Conferences allow collaboration within the specialty on a national level and foster relationships between residency programs.

 

 

In addition, national groups such as the Women’s Dermatologic Society, the Skin of Color Society, and the American Academy of Dermatology Diversity, Equity, and Inclusion task force meet at the national conferences and discuss their next initiatives and projects. Joining a society of your interest can lead to many new networks and relationships you may not have had before. Even if you are not interested in specializing after general dermatology, consider attending a surgery, dermatopathology, or pediatric or cosmetic dermatology conference to learn more about the field from the experts.

Repair Conflicts and Build a Climate of Collaboration

Conflicts and disagreements unfortunately are inevitable during residency. Whether they involve planning vacation times or coordinating call schedules, everyone will not agree on every decision. Learning how to handle and approach conflict with co-residents is of utmost importance to maintaining the hard work you have put in to create trust, camaraderie, and a good social atmosphere. If you are having an issue with a circumstance involving a co-resident, holding a grudge will only sour your experience and the experience of others. Talking to your co-resident directly about your concerns before escalating the issue to a chief resident or faculty member is a great start. Consider asking them about their thought process and show concern for their point of view. Listen to them openly before going into your preferences. It is important to remember that working as a team requires sacrifices, and sometimes you will not be satisfied with the outcome of a conflict.

It also is important to remember that feelings change, and an issue you feel you must address immediately can wait to be addressed at a better time when you have calmed down. You may even find that you decide not to address it at all. At the end of the day, if a conflict cannot be worked out between those involved, consider confiding in a chief resident or a faculty mentor for advice on the next steps to take to resolve the problem. Ultimately, having a good foundation of respect and strong bonds with your residents will help tremendously when conflicts arise.

Final Thoughts

Fostering camaraderie in residency will improve the overall experience and lives of the residents, as well as the experience of the faculty, staff, and patients by the trickle-down effect. Creating a cheerful and fun atmosphere filled with inside jokes and excitement regarding upcoming social events or conferences will certainly result in a time you will cherish for the rest of your life.

References
  1. Kouzes JM, Posner BZ. Foster collaboration. In: Kouzes JM, Posner BZ, eds. The Leadership Challenge. 6th ed. John Wiley & Sons, Inc; 2017:195-217.
  2. Cooper J, Shao K, Feng H. Racial/ethnic health disparities in dermatology in the United States, part 1: overview of contributing factors and management strategies [published online February 7, 2022]. J Am Acad Dermatol. 2022;87:723-730. doi:10.1016/j.jaad.2021.12.061
References
  1. Kouzes JM, Posner BZ. Foster collaboration. In: Kouzes JM, Posner BZ, eds. The Leadership Challenge. 6th ed. John Wiley & Sons, Inc; 2017:195-217.
  2. Cooper J, Shao K, Feng H. Racial/ethnic health disparities in dermatology in the United States, part 1: overview of contributing factors and management strategies [published online February 7, 2022]. J Am Acad Dermatol. 2022;87:723-730. doi:10.1016/j.jaad.2021.12.061
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Resident Pearls

  • Camaraderie in residency is a special dynamic that can be enhanced and fostered in many different ways.
  • The relationships among residents should be treated with importance, as some of the friends you make will last a career and/or a lifetime.
  • Conflicts inevitably will arise and learning how to handle them effectively can improve the residency experience.
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More on social entropy

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As leaders of the American Psychiatric Association, we received dozens of communications from members who were shocked by the discriminatory and transphobic commentary in the recent editorial “The accelerating societal entropy undermines mental health” (Current Psychiatry, October 2022, p. 7-8, 27, doi:10.12788/cp.0295). Many of the items on the list Dr. Nasrallah cited as “indicators” of chaos in society are ill-informed and harmful. The attack on gender nonbinary and transgender people, including children, perpetuates stigmatization of, and ongoing harm to, already vulnerable people.

Specifically, citing “lack of certainty about gender identity in children and adults” as an indicator of societal turmoil that undermines mental health is contrary to the scientific understanding of gender identity. Physicians have professional obligations to advance patients’ well-being and do no harm.

The medical profession, including psychiatry, is at a critical juncture in coming to terms with and dismantling its longstanding history of systemic racism and discrimination. Authors and editors must be aware that harmful and divisive language negatively affects mental health, especially for people who have been subject to discrimination individually and/or as members of historically excluded and/or minoritized groups.

In publishing this editorial, Current Psychiatry failed in its mission to enhance patient care and advance personal development for clinicians. An apology and retraction are in order.

Rebecca W. Brendel, MD, JD, DFAPA

President

American Psychiatric Association

Saul Levin, MD, MPA, FRCP-E, FRCPsych

CEO and Medical Director

American Psychiatric Association


Disclosures

The authors report no financial relationships with any companies whose products are mentioned in this letter, or with manufacturers of competing products.

Dr. Nasrallah responds

I regret that the sentence about gender identity in my October editorial was regarded as transphobic and harmful. While the phrasing reflected my patients’ comments to me, I realize my unfortunate choice of words deeply offended individuals who are transgender, who have been subjected to ongoing discrimination and prejudice.

I apologize to our readers; to my American Psychiatric Association LGBTQAI+ friends, colleagues, and relatives; and to the LGBTQAI+ community at large. The sentence has been deleted from the online version of my editorial. This has been a teachable moment for me.

Current Psychiatry has long supported LGBTQAI+ individuals and provided education for clinicians about issues related to gender and sexuality. Most recently, we published “A gender primer for psychiatrists” (Current Psychiatry, November 2022, p. 32-33, doi:10.12788/cp.0306). We are also working on an article for publication in a future issue about providing gender-affirming care for individuals who are gender nonbinary or transgender.

Henry A. Nasrallah, MD

Editor-In-Chief

Continue to: More on psychiatric documentation

 

 

More on psychiatric documentation

Dr. Joshi’s helpful discussion of clinical documentation strategies (“Medical record documentation: What to do, and what to avoid,” Current Psychiatry, October 2022, p. 46, 48, doi:10.12788/cp.0292) incisively frames the medical record as a multiuse tool for both ensuring continuity of care for the patient and demonstrating adherence to the standard of care by the clinician. In a similar vein, I hope the following general medicolegal observations may prove useful to busy psychiatric practitioners.

The mental health record may not always be as confidential as psychiatrists think (or hope) it is. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, for example, generally does not distinguish between medical and mental health information, nor does it provide special rules for the latter (although certain state laws may do so). HIPAA provides added protections for “psychotherapy notes,” but this category explicitly excludes progress notes that discuss treatment modalities, diagnosis, and clinical milestones. To retain their protected status, psychotherapists’ private, “desk-drawer memory joggers” must never be comingled with the patient chart.1 For mental health professionals, this distinction underscores the importance of keeping personal details broad in the progress note; scandalous or embarrassing narratives recounted in the medical record itself are routinely accessible to the patient and may be lawfully disclosed to others under specified circumstances.

In addition to avoiding speculation and including patient quotes when appropriate, documenting objectively and nonjudgmentally means annotating facts and observations that helped the clinician arrive at their conclusion. For example, “patient appears intoxicated” is less helpful than noting the patient’s slurred speech, impaired gait and/or coordination, and alcohol odor.

Clinical care and its associated documentation are so intertwined that they can become virtually indistinguishable. In a medical malpractice case, the burden is on the plaintiff to prove their injury resulted from substandard care. Some courts, however, have held that missing or incomplete records can effectively shift the burden from the recipient to the provider of care to show that the treatment at issue was rendered non-negligently.2 Statutes of limitations restricting the amount of time in which a patient can sue after an adverse event are sometimes triggered by the date on which they knew or should have known of the alleged malpractice.3 One of the best ways of ascertaining this date, and starting the statute of limitations clock, can be a clear annotation in the medical record that the patient was apprised of an unanticipated outcome or iatrogenic harm. In this way, a timely and thorough note can be critical not just to defending the physician’s quality of care, but potentially to precluding a cognizable lawsuit altogether.

Charles G. Kels, JD

Defense Health Agency

San Antonio, Texas

Disclosures

The views expressed are those of the author and do not necessarily reflect those of any government agency, nor do they constitute individualized legal advice. The author reports no financial relationships with any companies whose products are mentioned in this letter, or with manufacturers of competing products.

References

1. 45 CFR Parts 160 and 164, Subparts A and E.

2. Valcin v Public Health Trust, 473 So. 2d 1297 (1984).

3. US v Kubrick, 444 US 111 (1979).

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As leaders of the American Psychiatric Association, we received dozens of communications from members who were shocked by the discriminatory and transphobic commentary in the recent editorial “The accelerating societal entropy undermines mental health” (Current Psychiatry, October 2022, p. 7-8, 27, doi:10.12788/cp.0295). Many of the items on the list Dr. Nasrallah cited as “indicators” of chaos in society are ill-informed and harmful. The attack on gender nonbinary and transgender people, including children, perpetuates stigmatization of, and ongoing harm to, already vulnerable people.

Specifically, citing “lack of certainty about gender identity in children and adults” as an indicator of societal turmoil that undermines mental health is contrary to the scientific understanding of gender identity. Physicians have professional obligations to advance patients’ well-being and do no harm.

The medical profession, including psychiatry, is at a critical juncture in coming to terms with and dismantling its longstanding history of systemic racism and discrimination. Authors and editors must be aware that harmful and divisive language negatively affects mental health, especially for people who have been subject to discrimination individually and/or as members of historically excluded and/or minoritized groups.

In publishing this editorial, Current Psychiatry failed in its mission to enhance patient care and advance personal development for clinicians. An apology and retraction are in order.

Rebecca W. Brendel, MD, JD, DFAPA

President

American Psychiatric Association

Saul Levin, MD, MPA, FRCP-E, FRCPsych

CEO and Medical Director

American Psychiatric Association


Disclosures

The authors report no financial relationships with any companies whose products are mentioned in this letter, or with manufacturers of competing products.

Dr. Nasrallah responds

I regret that the sentence about gender identity in my October editorial was regarded as transphobic and harmful. While the phrasing reflected my patients’ comments to me, I realize my unfortunate choice of words deeply offended individuals who are transgender, who have been subjected to ongoing discrimination and prejudice.

I apologize to our readers; to my American Psychiatric Association LGBTQAI+ friends, colleagues, and relatives; and to the LGBTQAI+ community at large. The sentence has been deleted from the online version of my editorial. This has been a teachable moment for me.

Current Psychiatry has long supported LGBTQAI+ individuals and provided education for clinicians about issues related to gender and sexuality. Most recently, we published “A gender primer for psychiatrists” (Current Psychiatry, November 2022, p. 32-33, doi:10.12788/cp.0306). We are also working on an article for publication in a future issue about providing gender-affirming care for individuals who are gender nonbinary or transgender.

Henry A. Nasrallah, MD

Editor-In-Chief

Continue to: More on psychiatric documentation

 

 

More on psychiatric documentation

Dr. Joshi’s helpful discussion of clinical documentation strategies (“Medical record documentation: What to do, and what to avoid,” Current Psychiatry, October 2022, p. 46, 48, doi:10.12788/cp.0292) incisively frames the medical record as a multiuse tool for both ensuring continuity of care for the patient and demonstrating adherence to the standard of care by the clinician. In a similar vein, I hope the following general medicolegal observations may prove useful to busy psychiatric practitioners.

The mental health record may not always be as confidential as psychiatrists think (or hope) it is. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, for example, generally does not distinguish between medical and mental health information, nor does it provide special rules for the latter (although certain state laws may do so). HIPAA provides added protections for “psychotherapy notes,” but this category explicitly excludes progress notes that discuss treatment modalities, diagnosis, and clinical milestones. To retain their protected status, psychotherapists’ private, “desk-drawer memory joggers” must never be comingled with the patient chart.1 For mental health professionals, this distinction underscores the importance of keeping personal details broad in the progress note; scandalous or embarrassing narratives recounted in the medical record itself are routinely accessible to the patient and may be lawfully disclosed to others under specified circumstances.

In addition to avoiding speculation and including patient quotes when appropriate, documenting objectively and nonjudgmentally means annotating facts and observations that helped the clinician arrive at their conclusion. For example, “patient appears intoxicated” is less helpful than noting the patient’s slurred speech, impaired gait and/or coordination, and alcohol odor.

Clinical care and its associated documentation are so intertwined that they can become virtually indistinguishable. In a medical malpractice case, the burden is on the plaintiff to prove their injury resulted from substandard care. Some courts, however, have held that missing or incomplete records can effectively shift the burden from the recipient to the provider of care to show that the treatment at issue was rendered non-negligently.2 Statutes of limitations restricting the amount of time in which a patient can sue after an adverse event are sometimes triggered by the date on which they knew or should have known of the alleged malpractice.3 One of the best ways of ascertaining this date, and starting the statute of limitations clock, can be a clear annotation in the medical record that the patient was apprised of an unanticipated outcome or iatrogenic harm. In this way, a timely and thorough note can be critical not just to defending the physician’s quality of care, but potentially to precluding a cognizable lawsuit altogether.

Charles G. Kels, JD

Defense Health Agency

San Antonio, Texas

Disclosures

The views expressed are those of the author and do not necessarily reflect those of any government agency, nor do they constitute individualized legal advice. The author reports no financial relationships with any companies whose products are mentioned in this letter, or with manufacturers of competing products.

References

1. 45 CFR Parts 160 and 164, Subparts A and E.

2. Valcin v Public Health Trust, 473 So. 2d 1297 (1984).

3. US v Kubrick, 444 US 111 (1979).

As leaders of the American Psychiatric Association, we received dozens of communications from members who were shocked by the discriminatory and transphobic commentary in the recent editorial “The accelerating societal entropy undermines mental health” (Current Psychiatry, October 2022, p. 7-8, 27, doi:10.12788/cp.0295). Many of the items on the list Dr. Nasrallah cited as “indicators” of chaos in society are ill-informed and harmful. The attack on gender nonbinary and transgender people, including children, perpetuates stigmatization of, and ongoing harm to, already vulnerable people.

Specifically, citing “lack of certainty about gender identity in children and adults” as an indicator of societal turmoil that undermines mental health is contrary to the scientific understanding of gender identity. Physicians have professional obligations to advance patients’ well-being and do no harm.

The medical profession, including psychiatry, is at a critical juncture in coming to terms with and dismantling its longstanding history of systemic racism and discrimination. Authors and editors must be aware that harmful and divisive language negatively affects mental health, especially for people who have been subject to discrimination individually and/or as members of historically excluded and/or minoritized groups.

In publishing this editorial, Current Psychiatry failed in its mission to enhance patient care and advance personal development for clinicians. An apology and retraction are in order.

Rebecca W. Brendel, MD, JD, DFAPA

President

American Psychiatric Association

Saul Levin, MD, MPA, FRCP-E, FRCPsych

CEO and Medical Director

American Psychiatric Association


Disclosures

The authors report no financial relationships with any companies whose products are mentioned in this letter, or with manufacturers of competing products.

Dr. Nasrallah responds

I regret that the sentence about gender identity in my October editorial was regarded as transphobic and harmful. While the phrasing reflected my patients’ comments to me, I realize my unfortunate choice of words deeply offended individuals who are transgender, who have been subjected to ongoing discrimination and prejudice.

I apologize to our readers; to my American Psychiatric Association LGBTQAI+ friends, colleagues, and relatives; and to the LGBTQAI+ community at large. The sentence has been deleted from the online version of my editorial. This has been a teachable moment for me.

Current Psychiatry has long supported LGBTQAI+ individuals and provided education for clinicians about issues related to gender and sexuality. Most recently, we published “A gender primer for psychiatrists” (Current Psychiatry, November 2022, p. 32-33, doi:10.12788/cp.0306). We are also working on an article for publication in a future issue about providing gender-affirming care for individuals who are gender nonbinary or transgender.

Henry A. Nasrallah, MD

Editor-In-Chief

Continue to: More on psychiatric documentation

 

 

More on psychiatric documentation

Dr. Joshi’s helpful discussion of clinical documentation strategies (“Medical record documentation: What to do, and what to avoid,” Current Psychiatry, October 2022, p. 46, 48, doi:10.12788/cp.0292) incisively frames the medical record as a multiuse tool for both ensuring continuity of care for the patient and demonstrating adherence to the standard of care by the clinician. In a similar vein, I hope the following general medicolegal observations may prove useful to busy psychiatric practitioners.

The mental health record may not always be as confidential as psychiatrists think (or hope) it is. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, for example, generally does not distinguish between medical and mental health information, nor does it provide special rules for the latter (although certain state laws may do so). HIPAA provides added protections for “psychotherapy notes,” but this category explicitly excludes progress notes that discuss treatment modalities, diagnosis, and clinical milestones. To retain their protected status, psychotherapists’ private, “desk-drawer memory joggers” must never be comingled with the patient chart.1 For mental health professionals, this distinction underscores the importance of keeping personal details broad in the progress note; scandalous or embarrassing narratives recounted in the medical record itself are routinely accessible to the patient and may be lawfully disclosed to others under specified circumstances.

In addition to avoiding speculation and including patient quotes when appropriate, documenting objectively and nonjudgmentally means annotating facts and observations that helped the clinician arrive at their conclusion. For example, “patient appears intoxicated” is less helpful than noting the patient’s slurred speech, impaired gait and/or coordination, and alcohol odor.

Clinical care and its associated documentation are so intertwined that they can become virtually indistinguishable. In a medical malpractice case, the burden is on the plaintiff to prove their injury resulted from substandard care. Some courts, however, have held that missing or incomplete records can effectively shift the burden from the recipient to the provider of care to show that the treatment at issue was rendered non-negligently.2 Statutes of limitations restricting the amount of time in which a patient can sue after an adverse event are sometimes triggered by the date on which they knew or should have known of the alleged malpractice.3 One of the best ways of ascertaining this date, and starting the statute of limitations clock, can be a clear annotation in the medical record that the patient was apprised of an unanticipated outcome or iatrogenic harm. In this way, a timely and thorough note can be critical not just to defending the physician’s quality of care, but potentially to precluding a cognizable lawsuit altogether.

Charles G. Kels, JD

Defense Health Agency

San Antonio, Texas

Disclosures

The views expressed are those of the author and do not necessarily reflect those of any government agency, nor do they constitute individualized legal advice. The author reports no financial relationships with any companies whose products are mentioned in this letter, or with manufacturers of competing products.

References

1. 45 CFR Parts 160 and 164, Subparts A and E.

2. Valcin v Public Health Trust, 473 So. 2d 1297 (1984).

3. US v Kubrick, 444 US 111 (1979).

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An overlooked cause of catatonia

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Thu, 12/01/2022 - 11:42
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An overlooked cause of catatonia

CASE Agitation and bizarre behavior

Ms. L, age 40, presents to the emergency department (ED) for altered mental status and bizarre behavior. Before arriving at the ED, she had experienced a severe headache and an episode of vomiting. At home she had been irritable and agitated, repetitively dressing and undressing, urinating outside the toilet, and opening and closing water faucets in the house. She also had stopped eating and drinking. Ms. L’s home medications consist of levothyroxine 100 mcg/d for hypothyroidism.

In the ED, Ms. L has severe psychomotor agitation. She is restless and displays purposeless repetitive movements with her hands. She is mostly mute, but does groan at times.

HISTORY Multiple trips to the ED

In addition to hypothyroidism, Ms. L has a history of migraines and asthma. Four days before presenting to the ED, she complained of a severe headache and generalized fatigue, with vomiting and nausea. Two days later, she presented to the ED at a different hospital and underwent a brain CT scan; the results were unremarkable. At that facility, a laboratory work-up—including complete blood count, urea, creatinine, C-reactive protein, electrolytes, magnesium, phosphorus, calcium, full liver function tests, amylase, lipase, bilirubin, thyroid function test, and beta-human chorionic gonadotropin—was normal except for low thyroid-stimulating hormone levels (0.016 mIU/L). Ms. L was diagnosed with a severe migraine attack and discharged home with instructions to follow up with her endocrinologist.

Ms. L has no previous psychiatric history. Her family’s psychiatric history includes depression with psychotic features (mother), depression (maternal aunt), and generalized anxiety disorder (mother’s maternal aunt).

[polldaddy:11252938]

The authors’ observations

Catatonia is a behavioral syndrome with heterogeneous signs and symptoms. According to DSM-5, the diagnosis is considered when a patient presents with ≥3 of the 12 signs outlined in Table 1.1 It usually occurs in the context of an underlying psychiatric disorder such as schizophrenia or depression, or a medical disorder such as CNS infection or encephalopathy due to metabolic causes.1 Ms. L exhibited mutism, negativism, mannerism, stereotypy, and agitation and thus met the criteria for a catatonia diagnosis.

Signs of catatonia

EVALUATION Unexpected finding on physical exam

In the ED, Ms. L is hemodynamically stable. Her blood pressure is 140/80 mm Hg; heart rate is 103 beats per minute; oxygen saturation is 98%; respiratory rate is 14 breaths per minute; and temperature is 37.5° C. Results from a brain MRI and total body scan performed prior to admission are unremarkable.

Ms. L is admitted to the psychiatric ward under the care of neurology for a psychiatry consultation. For approximately 24 hours, she receives IV diazepam 5 mg every 8 hours (due to the unavailability of lorazepam) for management of her catatonic symptoms, and olanzapine 10 mg every 8 hours orally as needed for agitation. Collateral history rules out a current mood episode or onset of psychosis in the weeks before she came to the ED. Diazepam improves Ms. L’s psychomotor agitation, which allows the primary team an opportunity to examine her.

Continue to: A physical exam reveals...

 

 

A physical exam reveals small vesicular lesions (1 to 2 cm in diameter) on an erythematous base on the left breast associated with an erythematous plaque with no evident vesicles on the left inner arm. The vesicular lesions display in a segmented pattern of dermatomal distribution.

[polldaddy:11252941]

The authors’ observations

Catatonic symptoms, coupled with psychomotor agitation in an immunocompetent middle-aged adult with a history of migraine headaches, strong family history of severe mental illness, and noncontributory findings on brain imaging, prompted a Psychiatry consultation and administration of psychotropic medications. A thorough physical exam revealing the small area of shingles and acute altered mental status prompted more aggressive investigations to explore the possibility of encephalitis.

Physicians should have a low index of suspicion for encephalitis (viral, bacterial, autoimmune, etc) and perform a lumbar puncture (LP) when necessary, despite the invasiveness of this test. A direct physical examination is often underutilized, notably in psychiatric patients, which can lead to the omission of important clinical information.2 Normal vital signs, blood workup, and MRI before admission are not sufficient to correctly guide diagnosis.

EVALUATION Additional lab results establish the diagnosis

An LP reveals Ms. L’s protein levels are 44 mg/dL, her glucose levels are 85 mg/dL, red blood cell count is 4/µL, and white blood cell count is 200/µL with 92% lymphocytes and 1% neutrophils. Ms. L’s CSF analysis profile indicates a viral CNS infection (Table 23).

Patterns of findings of cerebrospinal fluid analysis in bacterial, viral, and fungal encephalitis

[polldaddy:11252943]

The authors’ observations

Varicella-zoster virus (VZV) and herpes simplex virus (HSV) are human neurotropic alphaherpesviruses that cause lifelong infections in ganglia, and their reactivation can come in the form of encephalitis.4

Continue to: Ms. L's clinical presentation...

 

 

Ms. L’s clinical presentation most likely implicated VZV. Skin lesions of VZV may look exactly like HSV, with clustered vesicles on an erythematous base (Figure5). However, VZV rash tends to follow a dermatomal distribution (as in Ms. L’s case), which can help distinguish it from herpetic lesions.

Varicella-zoster virus with clustered vesicles on an erythematous base


Cases of VZV infection have been increasing worldwide. It is usually seen in older adults or those with compromised immunity.6 Significantly higher rates of VZV complications have been reported in such patients. A serious complication is VZV encephalitis, which is rare but possible, even in healthy individuals.6 VZV encephalitis can present with atypical psychiatric features. Ms. L exhibited several symptoms of VZV encephalitis, which include headache, fever, vomiting, altered level of consciousness, and seizures. An EEG also showed intermittent generalized slow waves in the range of theta commonly seen in encephalitis.

Ms. L’s case shows the importance of early recognition of VZV infection. The diagnosis is confirmed through CSF analysis. There is an urgency to promptly conduct the LP to confirm the diagnosis and quickly initiate antiviral treatment to stop the progression of the infection and its life-threatening sequelae.

In the absence of underlying medical cause, typical treatment of catatonia involves the sublingual or IM administration of 1 to 2 mg lorazepam that can be repeated twice at 3-hour intervals if the patient’s symptoms do not resolve. ECT is indicated if the patient experiences minimal or no response to lorazepam.

The use of antipsychotics for catatonia is controversial. High-potency antipsychotics such as haloperidol and risperidone are not recommended due to increased risk of the progression of catatonia into neuroleptic malignant syndrome.7

Continue to: OUTCOME Prompt recovery with an antiviral

 

 

OUTCOME Prompt recovery with an antiviral

Ms. L receives IV acyclovir 1,200 mg every 8 hours for 14 days. Just 48 hours after starting this antiviral medication, her bizarre behavior and catatonic features cease, and she returns to her baseline mental functioning. Olanzapine is discontinued, and lorazepam is progressively decreased. The CSF polymerase chain reaction assay indicates Ms. L is positive for VZV, which confirms the diagnosis of VZV encephalitis. A spine MRI is also performed and rules out myelitis as a sequela of the infection.

The authors’ observations

Chickenpox is caused by a primary encounter with VZV. Inside the ganglions of neurons, a dormant form of VZV resides. Its reactivation leads to the spread of the infection to the skin innervated by these neurons, causing shingles. Reactivation occurs in approximately 1 million people in the United States each year. The annual incidence is 5 to 6.5 cases per 1,000 people at age 60, and 8 to 11 cases per 1,000 people at age 70.8

In 2006, the FDA approved the first zoster vaccine (Zostavax) for use in nonimmunocompromised, VZV-seropositive adults age >60 (later lowered to age 50). This vaccine reduces the incidence of shingles by 51%, the incidence of postherpetic neuralgia by 66%, and the burden of illness by 61%. In 2017, the FDA approved a second VZV vaccine (Shingrix, recombinant nonlive vaccine). In 2021, Shingrix was approved for use in immunosuppressed patients.9

Reactivation of VZV starts with a prodromal phase, characterized by pain, itching, numbness, and dysesthesias in 1 to 3 dermatomes. A maculopapular rash appears on the affected area a few days later, evolving into vesicles that scab over in 10 days.10

Dissemination of the virus leading specifically to VZV encephalitis typically occurs in immunosuppressed individuals and older patients. According to the World Health Organization, encephalitis is a life-threatening complication of VZV and occurs in 1 of 33,000 to 50,000 cases.11

Continue to: Delay in the diagnosis...

 

 

Delay in the diagnosis and treatment of VZV encephalitis can be detrimental or even fatal. Kodadhala et al12 found that the mortality rate for VZV encephalitis is 5% to 10% and ≤80% in immunosuppressed individuals.

Sometimes, VZV encephalitis can masquerade as a psychiatric presentation. Few cases presenting with acute or delayed neuro­psychiatric symptoms related to VZV encephalitis have been previously reported in the literature. Some are summarized in Table 313,14 and Table 4.15,16

Acute psychiatric presentations of VZV encephalitis

To our knowledge, this is the first case report of catatonia as a presentation of VZV encephalitis. The catatonic presentation has been previously described in autoimmune encephalitis such as N-methyl-D-aspartate receptor encephalitis, due to glutamatergic hypofunction.17

Delayed neuropsychiatric presentations after VZV encephalitis

Bottom Line

In the setting of a patient with an abrupt change in mental status/behavior, physicians must be aware of the importance of a thorough physical examination to better ascertain a diagnosis and to rule out an underlying medical disorder. Reactivation of varicella-zoster virus (VZV) can result in encephalitis that might masquerade as a psychiatric presentation, including symptoms of catatonia.

Related Resources

Drug Brand Names

Acyclovir • Sitavig
Diazepam • Valium
Haloperidol • Haldol
Lorazepam • Ativan
Levothyroxine • Levoxyl
Olanzapine • Zyprexa
Risperidone • Risperdal

References

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.

2. Sanders RD, Keshavan MS. Physical and neurologic examinations in neuropsychiatry. Semin Clin Neuropsychiatry. 2002;7(1):18-29.

3. Howes DS, Lazoff M. Encephalitis workup. Medscape. Updated August 7, 2018. Accessed August 9, 2022. https://emedicine.medscape.com/article/791896-workup#c11

4. Kennedy PG, Rovnak J, Badani H, et al. A comparison of herpes simplex virus type 1 and varicella-zoster virus latency and reactivation. J Gen Virol. 2015;96(Pt 7):1581-1602.

5. Fisle, CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0). Wikimedia Commons. https://upload.wikimedia.org/wikipedia/commons/1/19/Herpes_zoster_chest.png

6. John AR, Canaday DH. Herpes zoster in the older adult. Infect Dis Clin North Am. 2017;31(4):811-826.

7. Rosebush PI, Mazurek MF. Catatonia and its treatment. Schizophr Bull. 2010;36(2):239-242.

8. Gershon AA, Breuer J, Cohen JI, et al. Varicella zoster virus infection. Nat Rev Dis Primers. 2015;1:15016.

9. Raedler LA. Shingrix (zoster vaccine recombinant) a new vaccine approved for herpes zoster prevention in older adults. American Health & Drug Benefits, Ninth Annual Payers’ Guide. March 2018. Updated August 30, 2021. Accessed August 9, 2022. https://www.ahdbonline.com/issues/2018/april-2018-vol-11-ninth-annual-payers-guide/2567-shingrix-zoster-vaccine-recombinant-a-new-vaccine-approved-for-herpes-zoster-prevention-in-older-adults

10. Nair PA, Patel BC. Herpes zoster. StatPearls [Internet]. StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK441824/

11. Lizzi J, Hill T, Jakubowski J. Varicella zoster virus encephalitis. Clin Pract Cases Emerg Med. 2019;3(4):380-382.

12. Kodadhala V, Dessalegn M, Barned S, et al. 578: Varicella encephalitis: a rare complication of herpes zoster in an elderly patient. Crit Care Med. 2019;47(1):269.

13. Tremolizzo L, Tremolizzo S, Beghi M, et al. Mood disorder with psychotic symptoms and overlooked skin lesions: the strange case of Mrs. O. Riv Psichiatr. 2012;47(5):447-450.

14. George O, Daniel J, Forsyth S, et al. Mania presenting as a VZV encephalitis in the context of HIV. BMJ Case Rep. 2020;13(9):e230512.

15. Bangen KJ, Delano-Wood L, Wierenga CE, et al. Dementia following herpes zoster encephalitis. Clin Neuropsychol. 2010;24(7):1193-1203.

16. McKenna KF, Warneke LB. Encephalitis associated with herpes zoster: a case report and review. Can J Psychiatry. 1992;37(4):271-273.

17. Rogers JP, Pollak TA, Blackman G, et al. Catatonia and the immune system: a review. Lancet Psychiatry. 2019;6(7):620-630.

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Mr. Ibrahim is a 3rd-year medical student, University of Balamand, Faculty of Medicine, Al Koura, Lebanon. Dr. El Rassi is a PGY-2 Resident, Department of Family Medicine, Saint George Hospital University Medical Center, Beirut, Lebanon. Dr. Jabbour is Neurologist, Department of Neurology, Saint George Hospital University Medical Center, Beirut, Lebanon. Dr. Khoury is Adult and Geriatric Psychiatrist, Department of Psychiatry and Clinical Psychology, Saint George Hospital University Medical Center, Beirut, Lebanon.

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The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

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Mr. Ibrahim is a 3rd-year medical student, University of Balamand, Faculty of Medicine, Al Koura, Lebanon. Dr. El Rassi is a PGY-2 Resident, Department of Family Medicine, Saint George Hospital University Medical Center, Beirut, Lebanon. Dr. Jabbour is Neurologist, Department of Neurology, Saint George Hospital University Medical Center, Beirut, Lebanon. Dr. Khoury is Adult and Geriatric Psychiatrist, Department of Psychiatry and Clinical Psychology, Saint George Hospital University Medical Center, Beirut, Lebanon.

Disclosures
The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

Author and Disclosure Information

Mr. Ibrahim is a 3rd-year medical student, University of Balamand, Faculty of Medicine, Al Koura, Lebanon. Dr. El Rassi is a PGY-2 Resident, Department of Family Medicine, Saint George Hospital University Medical Center, Beirut, Lebanon. Dr. Jabbour is Neurologist, Department of Neurology, Saint George Hospital University Medical Center, Beirut, Lebanon. Dr. Khoury is Adult and Geriatric Psychiatrist, Department of Psychiatry and Clinical Psychology, Saint George Hospital University Medical Center, Beirut, Lebanon.

Disclosures
The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

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CASE Agitation and bizarre behavior

Ms. L, age 40, presents to the emergency department (ED) for altered mental status and bizarre behavior. Before arriving at the ED, she had experienced a severe headache and an episode of vomiting. At home she had been irritable and agitated, repetitively dressing and undressing, urinating outside the toilet, and opening and closing water faucets in the house. She also had stopped eating and drinking. Ms. L’s home medications consist of levothyroxine 100 mcg/d for hypothyroidism.

In the ED, Ms. L has severe psychomotor agitation. She is restless and displays purposeless repetitive movements with her hands. She is mostly mute, but does groan at times.

HISTORY Multiple trips to the ED

In addition to hypothyroidism, Ms. L has a history of migraines and asthma. Four days before presenting to the ED, she complained of a severe headache and generalized fatigue, with vomiting and nausea. Two days later, she presented to the ED at a different hospital and underwent a brain CT scan; the results were unremarkable. At that facility, a laboratory work-up—including complete blood count, urea, creatinine, C-reactive protein, electrolytes, magnesium, phosphorus, calcium, full liver function tests, amylase, lipase, bilirubin, thyroid function test, and beta-human chorionic gonadotropin—was normal except for low thyroid-stimulating hormone levels (0.016 mIU/L). Ms. L was diagnosed with a severe migraine attack and discharged home with instructions to follow up with her endocrinologist.

Ms. L has no previous psychiatric history. Her family’s psychiatric history includes depression with psychotic features (mother), depression (maternal aunt), and generalized anxiety disorder (mother’s maternal aunt).

[polldaddy:11252938]

The authors’ observations

Catatonia is a behavioral syndrome with heterogeneous signs and symptoms. According to DSM-5, the diagnosis is considered when a patient presents with ≥3 of the 12 signs outlined in Table 1.1 It usually occurs in the context of an underlying psychiatric disorder such as schizophrenia or depression, or a medical disorder such as CNS infection or encephalopathy due to metabolic causes.1 Ms. L exhibited mutism, negativism, mannerism, stereotypy, and agitation and thus met the criteria for a catatonia diagnosis.

Signs of catatonia

EVALUATION Unexpected finding on physical exam

In the ED, Ms. L is hemodynamically stable. Her blood pressure is 140/80 mm Hg; heart rate is 103 beats per minute; oxygen saturation is 98%; respiratory rate is 14 breaths per minute; and temperature is 37.5° C. Results from a brain MRI and total body scan performed prior to admission are unremarkable.

Ms. L is admitted to the psychiatric ward under the care of neurology for a psychiatry consultation. For approximately 24 hours, she receives IV diazepam 5 mg every 8 hours (due to the unavailability of lorazepam) for management of her catatonic symptoms, and olanzapine 10 mg every 8 hours orally as needed for agitation. Collateral history rules out a current mood episode or onset of psychosis in the weeks before she came to the ED. Diazepam improves Ms. L’s psychomotor agitation, which allows the primary team an opportunity to examine her.

Continue to: A physical exam reveals...

 

 

A physical exam reveals small vesicular lesions (1 to 2 cm in diameter) on an erythematous base on the left breast associated with an erythematous plaque with no evident vesicles on the left inner arm. The vesicular lesions display in a segmented pattern of dermatomal distribution.

[polldaddy:11252941]

The authors’ observations

Catatonic symptoms, coupled with psychomotor agitation in an immunocompetent middle-aged adult with a history of migraine headaches, strong family history of severe mental illness, and noncontributory findings on brain imaging, prompted a Psychiatry consultation and administration of psychotropic medications. A thorough physical exam revealing the small area of shingles and acute altered mental status prompted more aggressive investigations to explore the possibility of encephalitis.

Physicians should have a low index of suspicion for encephalitis (viral, bacterial, autoimmune, etc) and perform a lumbar puncture (LP) when necessary, despite the invasiveness of this test. A direct physical examination is often underutilized, notably in psychiatric patients, which can lead to the omission of important clinical information.2 Normal vital signs, blood workup, and MRI before admission are not sufficient to correctly guide diagnosis.

EVALUATION Additional lab results establish the diagnosis

An LP reveals Ms. L’s protein levels are 44 mg/dL, her glucose levels are 85 mg/dL, red blood cell count is 4/µL, and white blood cell count is 200/µL with 92% lymphocytes and 1% neutrophils. Ms. L’s CSF analysis profile indicates a viral CNS infection (Table 23).

Patterns of findings of cerebrospinal fluid analysis in bacterial, viral, and fungal encephalitis

[polldaddy:11252943]

The authors’ observations

Varicella-zoster virus (VZV) and herpes simplex virus (HSV) are human neurotropic alphaherpesviruses that cause lifelong infections in ganglia, and their reactivation can come in the form of encephalitis.4

Continue to: Ms. L's clinical presentation...

 

 

Ms. L’s clinical presentation most likely implicated VZV. Skin lesions of VZV may look exactly like HSV, with clustered vesicles on an erythematous base (Figure5). However, VZV rash tends to follow a dermatomal distribution (as in Ms. L’s case), which can help distinguish it from herpetic lesions.

Varicella-zoster virus with clustered vesicles on an erythematous base


Cases of VZV infection have been increasing worldwide. It is usually seen in older adults or those with compromised immunity.6 Significantly higher rates of VZV complications have been reported in such patients. A serious complication is VZV encephalitis, which is rare but possible, even in healthy individuals.6 VZV encephalitis can present with atypical psychiatric features. Ms. L exhibited several symptoms of VZV encephalitis, which include headache, fever, vomiting, altered level of consciousness, and seizures. An EEG also showed intermittent generalized slow waves in the range of theta commonly seen in encephalitis.

Ms. L’s case shows the importance of early recognition of VZV infection. The diagnosis is confirmed through CSF analysis. There is an urgency to promptly conduct the LP to confirm the diagnosis and quickly initiate antiviral treatment to stop the progression of the infection and its life-threatening sequelae.

In the absence of underlying medical cause, typical treatment of catatonia involves the sublingual or IM administration of 1 to 2 mg lorazepam that can be repeated twice at 3-hour intervals if the patient’s symptoms do not resolve. ECT is indicated if the patient experiences minimal or no response to lorazepam.

The use of antipsychotics for catatonia is controversial. High-potency antipsychotics such as haloperidol and risperidone are not recommended due to increased risk of the progression of catatonia into neuroleptic malignant syndrome.7

Continue to: OUTCOME Prompt recovery with an antiviral

 

 

OUTCOME Prompt recovery with an antiviral

Ms. L receives IV acyclovir 1,200 mg every 8 hours for 14 days. Just 48 hours after starting this antiviral medication, her bizarre behavior and catatonic features cease, and she returns to her baseline mental functioning. Olanzapine is discontinued, and lorazepam is progressively decreased. The CSF polymerase chain reaction assay indicates Ms. L is positive for VZV, which confirms the diagnosis of VZV encephalitis. A spine MRI is also performed and rules out myelitis as a sequela of the infection.

The authors’ observations

Chickenpox is caused by a primary encounter with VZV. Inside the ganglions of neurons, a dormant form of VZV resides. Its reactivation leads to the spread of the infection to the skin innervated by these neurons, causing shingles. Reactivation occurs in approximately 1 million people in the United States each year. The annual incidence is 5 to 6.5 cases per 1,000 people at age 60, and 8 to 11 cases per 1,000 people at age 70.8

In 2006, the FDA approved the first zoster vaccine (Zostavax) for use in nonimmunocompromised, VZV-seropositive adults age >60 (later lowered to age 50). This vaccine reduces the incidence of shingles by 51%, the incidence of postherpetic neuralgia by 66%, and the burden of illness by 61%. In 2017, the FDA approved a second VZV vaccine (Shingrix, recombinant nonlive vaccine). In 2021, Shingrix was approved for use in immunosuppressed patients.9

Reactivation of VZV starts with a prodromal phase, characterized by pain, itching, numbness, and dysesthesias in 1 to 3 dermatomes. A maculopapular rash appears on the affected area a few days later, evolving into vesicles that scab over in 10 days.10

Dissemination of the virus leading specifically to VZV encephalitis typically occurs in immunosuppressed individuals and older patients. According to the World Health Organization, encephalitis is a life-threatening complication of VZV and occurs in 1 of 33,000 to 50,000 cases.11

Continue to: Delay in the diagnosis...

 

 

Delay in the diagnosis and treatment of VZV encephalitis can be detrimental or even fatal. Kodadhala et al12 found that the mortality rate for VZV encephalitis is 5% to 10% and ≤80% in immunosuppressed individuals.

Sometimes, VZV encephalitis can masquerade as a psychiatric presentation. Few cases presenting with acute or delayed neuro­psychiatric symptoms related to VZV encephalitis have been previously reported in the literature. Some are summarized in Table 313,14 and Table 4.15,16

Acute psychiatric presentations of VZV encephalitis

To our knowledge, this is the first case report of catatonia as a presentation of VZV encephalitis. The catatonic presentation has been previously described in autoimmune encephalitis such as N-methyl-D-aspartate receptor encephalitis, due to glutamatergic hypofunction.17

Delayed neuropsychiatric presentations after VZV encephalitis

Bottom Line

In the setting of a patient with an abrupt change in mental status/behavior, physicians must be aware of the importance of a thorough physical examination to better ascertain a diagnosis and to rule out an underlying medical disorder. Reactivation of varicella-zoster virus (VZV) can result in encephalitis that might masquerade as a psychiatric presentation, including symptoms of catatonia.

Related Resources

Drug Brand Names

Acyclovir • Sitavig
Diazepam • Valium
Haloperidol • Haldol
Lorazepam • Ativan
Levothyroxine • Levoxyl
Olanzapine • Zyprexa
Risperidone • Risperdal

CASE Agitation and bizarre behavior

Ms. L, age 40, presents to the emergency department (ED) for altered mental status and bizarre behavior. Before arriving at the ED, she had experienced a severe headache and an episode of vomiting. At home she had been irritable and agitated, repetitively dressing and undressing, urinating outside the toilet, and opening and closing water faucets in the house. She also had stopped eating and drinking. Ms. L’s home medications consist of levothyroxine 100 mcg/d for hypothyroidism.

In the ED, Ms. L has severe psychomotor agitation. She is restless and displays purposeless repetitive movements with her hands. She is mostly mute, but does groan at times.

HISTORY Multiple trips to the ED

In addition to hypothyroidism, Ms. L has a history of migraines and asthma. Four days before presenting to the ED, she complained of a severe headache and generalized fatigue, with vomiting and nausea. Two days later, she presented to the ED at a different hospital and underwent a brain CT scan; the results were unremarkable. At that facility, a laboratory work-up—including complete blood count, urea, creatinine, C-reactive protein, electrolytes, magnesium, phosphorus, calcium, full liver function tests, amylase, lipase, bilirubin, thyroid function test, and beta-human chorionic gonadotropin—was normal except for low thyroid-stimulating hormone levels (0.016 mIU/L). Ms. L was diagnosed with a severe migraine attack and discharged home with instructions to follow up with her endocrinologist.

Ms. L has no previous psychiatric history. Her family’s psychiatric history includes depression with psychotic features (mother), depression (maternal aunt), and generalized anxiety disorder (mother’s maternal aunt).

[polldaddy:11252938]

The authors’ observations

Catatonia is a behavioral syndrome with heterogeneous signs and symptoms. According to DSM-5, the diagnosis is considered when a patient presents with ≥3 of the 12 signs outlined in Table 1.1 It usually occurs in the context of an underlying psychiatric disorder such as schizophrenia or depression, or a medical disorder such as CNS infection or encephalopathy due to metabolic causes.1 Ms. L exhibited mutism, negativism, mannerism, stereotypy, and agitation and thus met the criteria for a catatonia diagnosis.

Signs of catatonia

EVALUATION Unexpected finding on physical exam

In the ED, Ms. L is hemodynamically stable. Her blood pressure is 140/80 mm Hg; heart rate is 103 beats per minute; oxygen saturation is 98%; respiratory rate is 14 breaths per minute; and temperature is 37.5° C. Results from a brain MRI and total body scan performed prior to admission are unremarkable.

Ms. L is admitted to the psychiatric ward under the care of neurology for a psychiatry consultation. For approximately 24 hours, she receives IV diazepam 5 mg every 8 hours (due to the unavailability of lorazepam) for management of her catatonic symptoms, and olanzapine 10 mg every 8 hours orally as needed for agitation. Collateral history rules out a current mood episode or onset of psychosis in the weeks before she came to the ED. Diazepam improves Ms. L’s psychomotor agitation, which allows the primary team an opportunity to examine her.

Continue to: A physical exam reveals...

 

 

A physical exam reveals small vesicular lesions (1 to 2 cm in diameter) on an erythematous base on the left breast associated with an erythematous plaque with no evident vesicles on the left inner arm. The vesicular lesions display in a segmented pattern of dermatomal distribution.

[polldaddy:11252941]

The authors’ observations

Catatonic symptoms, coupled with psychomotor agitation in an immunocompetent middle-aged adult with a history of migraine headaches, strong family history of severe mental illness, and noncontributory findings on brain imaging, prompted a Psychiatry consultation and administration of psychotropic medications. A thorough physical exam revealing the small area of shingles and acute altered mental status prompted more aggressive investigations to explore the possibility of encephalitis.

Physicians should have a low index of suspicion for encephalitis (viral, bacterial, autoimmune, etc) and perform a lumbar puncture (LP) when necessary, despite the invasiveness of this test. A direct physical examination is often underutilized, notably in psychiatric patients, which can lead to the omission of important clinical information.2 Normal vital signs, blood workup, and MRI before admission are not sufficient to correctly guide diagnosis.

EVALUATION Additional lab results establish the diagnosis

An LP reveals Ms. L’s protein levels are 44 mg/dL, her glucose levels are 85 mg/dL, red blood cell count is 4/µL, and white blood cell count is 200/µL with 92% lymphocytes and 1% neutrophils. Ms. L’s CSF analysis profile indicates a viral CNS infection (Table 23).

Patterns of findings of cerebrospinal fluid analysis in bacterial, viral, and fungal encephalitis

[polldaddy:11252943]

The authors’ observations

Varicella-zoster virus (VZV) and herpes simplex virus (HSV) are human neurotropic alphaherpesviruses that cause lifelong infections in ganglia, and their reactivation can come in the form of encephalitis.4

Continue to: Ms. L's clinical presentation...

 

 

Ms. L’s clinical presentation most likely implicated VZV. Skin lesions of VZV may look exactly like HSV, with clustered vesicles on an erythematous base (Figure5). However, VZV rash tends to follow a dermatomal distribution (as in Ms. L’s case), which can help distinguish it from herpetic lesions.

Varicella-zoster virus with clustered vesicles on an erythematous base


Cases of VZV infection have been increasing worldwide. It is usually seen in older adults or those with compromised immunity.6 Significantly higher rates of VZV complications have been reported in such patients. A serious complication is VZV encephalitis, which is rare but possible, even in healthy individuals.6 VZV encephalitis can present with atypical psychiatric features. Ms. L exhibited several symptoms of VZV encephalitis, which include headache, fever, vomiting, altered level of consciousness, and seizures. An EEG also showed intermittent generalized slow waves in the range of theta commonly seen in encephalitis.

Ms. L’s case shows the importance of early recognition of VZV infection. The diagnosis is confirmed through CSF analysis. There is an urgency to promptly conduct the LP to confirm the diagnosis and quickly initiate antiviral treatment to stop the progression of the infection and its life-threatening sequelae.

In the absence of underlying medical cause, typical treatment of catatonia involves the sublingual or IM administration of 1 to 2 mg lorazepam that can be repeated twice at 3-hour intervals if the patient’s symptoms do not resolve. ECT is indicated if the patient experiences minimal or no response to lorazepam.

The use of antipsychotics for catatonia is controversial. High-potency antipsychotics such as haloperidol and risperidone are not recommended due to increased risk of the progression of catatonia into neuroleptic malignant syndrome.7

Continue to: OUTCOME Prompt recovery with an antiviral

 

 

OUTCOME Prompt recovery with an antiviral

Ms. L receives IV acyclovir 1,200 mg every 8 hours for 14 days. Just 48 hours after starting this antiviral medication, her bizarre behavior and catatonic features cease, and she returns to her baseline mental functioning. Olanzapine is discontinued, and lorazepam is progressively decreased. The CSF polymerase chain reaction assay indicates Ms. L is positive for VZV, which confirms the diagnosis of VZV encephalitis. A spine MRI is also performed and rules out myelitis as a sequela of the infection.

The authors’ observations

Chickenpox is caused by a primary encounter with VZV. Inside the ganglions of neurons, a dormant form of VZV resides. Its reactivation leads to the spread of the infection to the skin innervated by these neurons, causing shingles. Reactivation occurs in approximately 1 million people in the United States each year. The annual incidence is 5 to 6.5 cases per 1,000 people at age 60, and 8 to 11 cases per 1,000 people at age 70.8

In 2006, the FDA approved the first zoster vaccine (Zostavax) for use in nonimmunocompromised, VZV-seropositive adults age >60 (later lowered to age 50). This vaccine reduces the incidence of shingles by 51%, the incidence of postherpetic neuralgia by 66%, and the burden of illness by 61%. In 2017, the FDA approved a second VZV vaccine (Shingrix, recombinant nonlive vaccine). In 2021, Shingrix was approved for use in immunosuppressed patients.9

Reactivation of VZV starts with a prodromal phase, characterized by pain, itching, numbness, and dysesthesias in 1 to 3 dermatomes. A maculopapular rash appears on the affected area a few days later, evolving into vesicles that scab over in 10 days.10

Dissemination of the virus leading specifically to VZV encephalitis typically occurs in immunosuppressed individuals and older patients. According to the World Health Organization, encephalitis is a life-threatening complication of VZV and occurs in 1 of 33,000 to 50,000 cases.11

Continue to: Delay in the diagnosis...

 

 

Delay in the diagnosis and treatment of VZV encephalitis can be detrimental or even fatal. Kodadhala et al12 found that the mortality rate for VZV encephalitis is 5% to 10% and ≤80% in immunosuppressed individuals.

Sometimes, VZV encephalitis can masquerade as a psychiatric presentation. Few cases presenting with acute or delayed neuro­psychiatric symptoms related to VZV encephalitis have been previously reported in the literature. Some are summarized in Table 313,14 and Table 4.15,16

Acute psychiatric presentations of VZV encephalitis

To our knowledge, this is the first case report of catatonia as a presentation of VZV encephalitis. The catatonic presentation has been previously described in autoimmune encephalitis such as N-methyl-D-aspartate receptor encephalitis, due to glutamatergic hypofunction.17

Delayed neuropsychiatric presentations after VZV encephalitis

Bottom Line

In the setting of a patient with an abrupt change in mental status/behavior, physicians must be aware of the importance of a thorough physical examination to better ascertain a diagnosis and to rule out an underlying medical disorder. Reactivation of varicella-zoster virus (VZV) can result in encephalitis that might masquerade as a psychiatric presentation, including symptoms of catatonia.

Related Resources

Drug Brand Names

Acyclovir • Sitavig
Diazepam • Valium
Haloperidol • Haldol
Lorazepam • Ativan
Levothyroxine • Levoxyl
Olanzapine • Zyprexa
Risperidone • Risperdal

References

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.

2. Sanders RD, Keshavan MS. Physical and neurologic examinations in neuropsychiatry. Semin Clin Neuropsychiatry. 2002;7(1):18-29.

3. Howes DS, Lazoff M. Encephalitis workup. Medscape. Updated August 7, 2018. Accessed August 9, 2022. https://emedicine.medscape.com/article/791896-workup#c11

4. Kennedy PG, Rovnak J, Badani H, et al. A comparison of herpes simplex virus type 1 and varicella-zoster virus latency and reactivation. J Gen Virol. 2015;96(Pt 7):1581-1602.

5. Fisle, CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0). Wikimedia Commons. https://upload.wikimedia.org/wikipedia/commons/1/19/Herpes_zoster_chest.png

6. John AR, Canaday DH. Herpes zoster in the older adult. Infect Dis Clin North Am. 2017;31(4):811-826.

7. Rosebush PI, Mazurek MF. Catatonia and its treatment. Schizophr Bull. 2010;36(2):239-242.

8. Gershon AA, Breuer J, Cohen JI, et al. Varicella zoster virus infection. Nat Rev Dis Primers. 2015;1:15016.

9. Raedler LA. Shingrix (zoster vaccine recombinant) a new vaccine approved for herpes zoster prevention in older adults. American Health & Drug Benefits, Ninth Annual Payers’ Guide. March 2018. Updated August 30, 2021. Accessed August 9, 2022. https://www.ahdbonline.com/issues/2018/april-2018-vol-11-ninth-annual-payers-guide/2567-shingrix-zoster-vaccine-recombinant-a-new-vaccine-approved-for-herpes-zoster-prevention-in-older-adults

10. Nair PA, Patel BC. Herpes zoster. StatPearls [Internet]. StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK441824/

11. Lizzi J, Hill T, Jakubowski J. Varicella zoster virus encephalitis. Clin Pract Cases Emerg Med. 2019;3(4):380-382.

12. Kodadhala V, Dessalegn M, Barned S, et al. 578: Varicella encephalitis: a rare complication of herpes zoster in an elderly patient. Crit Care Med. 2019;47(1):269.

13. Tremolizzo L, Tremolizzo S, Beghi M, et al. Mood disorder with psychotic symptoms and overlooked skin lesions: the strange case of Mrs. O. Riv Psichiatr. 2012;47(5):447-450.

14. George O, Daniel J, Forsyth S, et al. Mania presenting as a VZV encephalitis in the context of HIV. BMJ Case Rep. 2020;13(9):e230512.

15. Bangen KJ, Delano-Wood L, Wierenga CE, et al. Dementia following herpes zoster encephalitis. Clin Neuropsychol. 2010;24(7):1193-1203.

16. McKenna KF, Warneke LB. Encephalitis associated with herpes zoster: a case report and review. Can J Psychiatry. 1992;37(4):271-273.

17. Rogers JP, Pollak TA, Blackman G, et al. Catatonia and the immune system: a review. Lancet Psychiatry. 2019;6(7):620-630.

References

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.

2. Sanders RD, Keshavan MS. Physical and neurologic examinations in neuropsychiatry. Semin Clin Neuropsychiatry. 2002;7(1):18-29.

3. Howes DS, Lazoff M. Encephalitis workup. Medscape. Updated August 7, 2018. Accessed August 9, 2022. https://emedicine.medscape.com/article/791896-workup#c11

4. Kennedy PG, Rovnak J, Badani H, et al. A comparison of herpes simplex virus type 1 and varicella-zoster virus latency and reactivation. J Gen Virol. 2015;96(Pt 7):1581-1602.

5. Fisle, CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0). Wikimedia Commons. https://upload.wikimedia.org/wikipedia/commons/1/19/Herpes_zoster_chest.png

6. John AR, Canaday DH. Herpes zoster in the older adult. Infect Dis Clin North Am. 2017;31(4):811-826.

7. Rosebush PI, Mazurek MF. Catatonia and its treatment. Schizophr Bull. 2010;36(2):239-242.

8. Gershon AA, Breuer J, Cohen JI, et al. Varicella zoster virus infection. Nat Rev Dis Primers. 2015;1:15016.

9. Raedler LA. Shingrix (zoster vaccine recombinant) a new vaccine approved for herpes zoster prevention in older adults. American Health & Drug Benefits, Ninth Annual Payers’ Guide. March 2018. Updated August 30, 2021. Accessed August 9, 2022. https://www.ahdbonline.com/issues/2018/april-2018-vol-11-ninth-annual-payers-guide/2567-shingrix-zoster-vaccine-recombinant-a-new-vaccine-approved-for-herpes-zoster-prevention-in-older-adults

10. Nair PA, Patel BC. Herpes zoster. StatPearls [Internet]. StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK441824/

11. Lizzi J, Hill T, Jakubowski J. Varicella zoster virus encephalitis. Clin Pract Cases Emerg Med. 2019;3(4):380-382.

12. Kodadhala V, Dessalegn M, Barned S, et al. 578: Varicella encephalitis: a rare complication of herpes zoster in an elderly patient. Crit Care Med. 2019;47(1):269.

13. Tremolizzo L, Tremolizzo S, Beghi M, et al. Mood disorder with psychotic symptoms and overlooked skin lesions: the strange case of Mrs. O. Riv Psichiatr. 2012;47(5):447-450.

14. George O, Daniel J, Forsyth S, et al. Mania presenting as a VZV encephalitis in the context of HIV. BMJ Case Rep. 2020;13(9):e230512.

15. Bangen KJ, Delano-Wood L, Wierenga CE, et al. Dementia following herpes zoster encephalitis. Clin Neuropsychol. 2010;24(7):1193-1203.

16. McKenna KF, Warneke LB. Encephalitis associated with herpes zoster: a case report and review. Can J Psychiatry. 1992;37(4):271-273.

17. Rogers JP, Pollak TA, Blackman G, et al. Catatonia and the immune system: a review. Lancet Psychiatry. 2019;6(7):620-630.

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Good news, bad news for GI in 2023 CMS physician fee schedule

Article Type
Changed
Wed, 11/30/2022 - 16:25

Medicare expanded coverage of colorectal cancer (CRC) testing through the 2023 physician payment rule while also finalizing certain mandated budget cuts. AGA and its sister societies praised the federal plan to increase access to screening but are among the groups now calling on Congress to prevent pay decreases.

The 2023 Medicare Physician Fee Schedule (MPFS) lowers the minimum age for CRC screening to 45 from 50 years, in keeping with the recommendation from the U.S. Preventive Services Task Force. The physician payment rule, which was unveiled on November 1, also ends the copay for colonoscopies that follow a positive stool-based colon cancer test. However, it is important to note that colonoscopies that involve polyp removal are still subject to Medicare coinsurance requirements, although the financial responsibility eventually diminishes to zero by 2030: From 2023 to 2026, patient responsibility is 15% of the cost; from 2027 to 2029 it falls to 10%; and by 2030 it will be covered 100% by Medicare.

These changes come after a year of intense advocacy led by AGA, including multiple meetings with senior officials at the Centers for Medicare and Medicaid Services and legislative pressure by members across the country. In the 2023 MPFS proposed rule, CMS attributed its decision to expand Medicare benefits to colonoscopy following a positive stool test to involvement from AGA, saying, “We consulted with and reviewed recommendations from a number of professional societies in developing this proposal, including supportive letters and communications with representatives from American Gastroenterological Association, American Cancer Society, and Fight Colorectal Cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the changes will lessen colorectal cancer disparities, eliminating a financial burden for many patients,” says AGA President John Carethers, MD, AGAF, who met with CMS earlier this year to advocate for the coverage of colonoscopy following a positive noninvasive colorectal cancer screening test.

David Lieberman, MD, AGAF, who met with CMS officials multiple times, offered, “Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in a CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”
 

‘Déjà vu all over again’

CMS uses its annual updates of the Physician Fee Schedule to make myriad policy decisions, with the 2023 version of the rule running close to 3,000 pages. AGA’s summary of the 2023 MPFS final rule highlights changes that impact gastroenterologists.

But the most controversial provisions in the rule involve federal mandates meant to control spending that CMS has no control over. These include a reduction in one of the variables used in determining payment, known as the conversion factor. This will fall by $1.55 from the current level of $34.61 to $33.06 in 2023.

There’s widespread agreement that Congress needs to reconsider its approach to setting Medicare payment for clinicians.

Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that were required under the old sustainable growth rate (SGR) formula.

The Medicare Access and CHIP Reauthorization Act of 2015 was supposed to end the annual battles over reimbursement cuts resulting from the SGR formula by changing the way physician payment is updated each year.

However, physicians face a 4.42% Medicare payment cut under the new payment system, as reflected in 2023 payment rule.

Two physicians serving in Congress, Rep. Ami Bera, MD (D-CA), and Rep. Larry Bucshon, MD (R-IN), have introduced legislation that would block next year’s cuts.

The current fight to stave off 2023 cuts seems like “déjà vu all over again,” said Kathleen Teixeira, AGA’s vice president of government affairs, in an interview with this news organization. Congress needs to shift away from the “Band-Aid approach” and concentrate on longer-term issues with physician payment, she said.

Rep. Bera and Rep. Buchson in September issued a letter seeking feedback on ways to “stabilize the Medicare payment system” without dramatically increasing the cost to taxpayers.

Louis Wilson, MD, chair of the American College of Gastroenterology’s legislative and public policy council, told this news organization that Congress needs to revisit Medicare’s physician payment system, especially in terms of addressing inflation.

Lawmakers’ attempts to restrain growth in Medicare physician payments have had the unintended consequence of fueling the acquisition of practices by hospitals, said Dr. Wilson, the managing partner of a physician-owned single-specialty private practice in Wichita Falls, Tex. Once doctors are employed by hospitals, Medicare often pays higher rates for their services than it would pay to physicians for providing the same care in a private practice.

Indeed, the Federal Trade Commission has said the U.S. physician workplace is “undergoing a dramatic restructuring,” with traditional solo practices and small single-specialty group practices rapidly being replaced by large multispecialty physician group practices, or practices that are owned or employed by hospital systems. The FTC is in the midst of a major series of studies on the effects of this consolidation.

“There’s been so much market distortion, so much limitation in innovation by failing to adequately pay in the Physician Fee Schedule, that the consequence is the widespread consolidation,” said Dr. Wilson. “That’s recognized on both sides of the aisle as being essentially expensive and inefficient and not in patients’ best interest.”

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Medicare expanded coverage of colorectal cancer (CRC) testing through the 2023 physician payment rule while also finalizing certain mandated budget cuts. AGA and its sister societies praised the federal plan to increase access to screening but are among the groups now calling on Congress to prevent pay decreases.

The 2023 Medicare Physician Fee Schedule (MPFS) lowers the minimum age for CRC screening to 45 from 50 years, in keeping with the recommendation from the U.S. Preventive Services Task Force. The physician payment rule, which was unveiled on November 1, also ends the copay for colonoscopies that follow a positive stool-based colon cancer test. However, it is important to note that colonoscopies that involve polyp removal are still subject to Medicare coinsurance requirements, although the financial responsibility eventually diminishes to zero by 2030: From 2023 to 2026, patient responsibility is 15% of the cost; from 2027 to 2029 it falls to 10%; and by 2030 it will be covered 100% by Medicare.

These changes come after a year of intense advocacy led by AGA, including multiple meetings with senior officials at the Centers for Medicare and Medicaid Services and legislative pressure by members across the country. In the 2023 MPFS proposed rule, CMS attributed its decision to expand Medicare benefits to colonoscopy following a positive stool test to involvement from AGA, saying, “We consulted with and reviewed recommendations from a number of professional societies in developing this proposal, including supportive letters and communications with representatives from American Gastroenterological Association, American Cancer Society, and Fight Colorectal Cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the changes will lessen colorectal cancer disparities, eliminating a financial burden for many patients,” says AGA President John Carethers, MD, AGAF, who met with CMS earlier this year to advocate for the coverage of colonoscopy following a positive noninvasive colorectal cancer screening test.

David Lieberman, MD, AGAF, who met with CMS officials multiple times, offered, “Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in a CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”
 

‘Déjà vu all over again’

CMS uses its annual updates of the Physician Fee Schedule to make myriad policy decisions, with the 2023 version of the rule running close to 3,000 pages. AGA’s summary of the 2023 MPFS final rule highlights changes that impact gastroenterologists.

But the most controversial provisions in the rule involve federal mandates meant to control spending that CMS has no control over. These include a reduction in one of the variables used in determining payment, known as the conversion factor. This will fall by $1.55 from the current level of $34.61 to $33.06 in 2023.

There’s widespread agreement that Congress needs to reconsider its approach to setting Medicare payment for clinicians.

Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that were required under the old sustainable growth rate (SGR) formula.

The Medicare Access and CHIP Reauthorization Act of 2015 was supposed to end the annual battles over reimbursement cuts resulting from the SGR formula by changing the way physician payment is updated each year.

However, physicians face a 4.42% Medicare payment cut under the new payment system, as reflected in 2023 payment rule.

Two physicians serving in Congress, Rep. Ami Bera, MD (D-CA), and Rep. Larry Bucshon, MD (R-IN), have introduced legislation that would block next year’s cuts.

The current fight to stave off 2023 cuts seems like “déjà vu all over again,” said Kathleen Teixeira, AGA’s vice president of government affairs, in an interview with this news organization. Congress needs to shift away from the “Band-Aid approach” and concentrate on longer-term issues with physician payment, she said.

Rep. Bera and Rep. Buchson in September issued a letter seeking feedback on ways to “stabilize the Medicare payment system” without dramatically increasing the cost to taxpayers.

Louis Wilson, MD, chair of the American College of Gastroenterology’s legislative and public policy council, told this news organization that Congress needs to revisit Medicare’s physician payment system, especially in terms of addressing inflation.

Lawmakers’ attempts to restrain growth in Medicare physician payments have had the unintended consequence of fueling the acquisition of practices by hospitals, said Dr. Wilson, the managing partner of a physician-owned single-specialty private practice in Wichita Falls, Tex. Once doctors are employed by hospitals, Medicare often pays higher rates for their services than it would pay to physicians for providing the same care in a private practice.

Indeed, the Federal Trade Commission has said the U.S. physician workplace is “undergoing a dramatic restructuring,” with traditional solo practices and small single-specialty group practices rapidly being replaced by large multispecialty physician group practices, or practices that are owned or employed by hospital systems. The FTC is in the midst of a major series of studies on the effects of this consolidation.

“There’s been so much market distortion, so much limitation in innovation by failing to adequately pay in the Physician Fee Schedule, that the consequence is the widespread consolidation,” said Dr. Wilson. “That’s recognized on both sides of the aisle as being essentially expensive and inefficient and not in patients’ best interest.”

Medicare expanded coverage of colorectal cancer (CRC) testing through the 2023 physician payment rule while also finalizing certain mandated budget cuts. AGA and its sister societies praised the federal plan to increase access to screening but are among the groups now calling on Congress to prevent pay decreases.

The 2023 Medicare Physician Fee Schedule (MPFS) lowers the minimum age for CRC screening to 45 from 50 years, in keeping with the recommendation from the U.S. Preventive Services Task Force. The physician payment rule, which was unveiled on November 1, also ends the copay for colonoscopies that follow a positive stool-based colon cancer test. However, it is important to note that colonoscopies that involve polyp removal are still subject to Medicare coinsurance requirements, although the financial responsibility eventually diminishes to zero by 2030: From 2023 to 2026, patient responsibility is 15% of the cost; from 2027 to 2029 it falls to 10%; and by 2030 it will be covered 100% by Medicare.

These changes come after a year of intense advocacy led by AGA, including multiple meetings with senior officials at the Centers for Medicare and Medicaid Services and legislative pressure by members across the country. In the 2023 MPFS proposed rule, CMS attributed its decision to expand Medicare benefits to colonoscopy following a positive stool test to involvement from AGA, saying, “We consulted with and reviewed recommendations from a number of professional societies in developing this proposal, including supportive letters and communications with representatives from American Gastroenterological Association, American Cancer Society, and Fight Colorectal Cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the changes will lessen colorectal cancer disparities, eliminating a financial burden for many patients,” says AGA President John Carethers, MD, AGAF, who met with CMS earlier this year to advocate for the coverage of colonoscopy following a positive noninvasive colorectal cancer screening test.

David Lieberman, MD, AGAF, who met with CMS officials multiple times, offered, “Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in a CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test.”
 

‘Déjà vu all over again’

CMS uses its annual updates of the Physician Fee Schedule to make myriad policy decisions, with the 2023 version of the rule running close to 3,000 pages. AGA’s summary of the 2023 MPFS final rule highlights changes that impact gastroenterologists.

But the most controversial provisions in the rule involve federal mandates meant to control spending that CMS has no control over. These include a reduction in one of the variables used in determining payment, known as the conversion factor. This will fall by $1.55 from the current level of $34.61 to $33.06 in 2023.

There’s widespread agreement that Congress needs to reconsider its approach to setting Medicare payment for clinicians.

Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that were required under the old sustainable growth rate (SGR) formula.

The Medicare Access and CHIP Reauthorization Act of 2015 was supposed to end the annual battles over reimbursement cuts resulting from the SGR formula by changing the way physician payment is updated each year.

However, physicians face a 4.42% Medicare payment cut under the new payment system, as reflected in 2023 payment rule.

Two physicians serving in Congress, Rep. Ami Bera, MD (D-CA), and Rep. Larry Bucshon, MD (R-IN), have introduced legislation that would block next year’s cuts.

The current fight to stave off 2023 cuts seems like “déjà vu all over again,” said Kathleen Teixeira, AGA’s vice president of government affairs, in an interview with this news organization. Congress needs to shift away from the “Band-Aid approach” and concentrate on longer-term issues with physician payment, she said.

Rep. Bera and Rep. Buchson in September issued a letter seeking feedback on ways to “stabilize the Medicare payment system” without dramatically increasing the cost to taxpayers.

Louis Wilson, MD, chair of the American College of Gastroenterology’s legislative and public policy council, told this news organization that Congress needs to revisit Medicare’s physician payment system, especially in terms of addressing inflation.

Lawmakers’ attempts to restrain growth in Medicare physician payments have had the unintended consequence of fueling the acquisition of practices by hospitals, said Dr. Wilson, the managing partner of a physician-owned single-specialty private practice in Wichita Falls, Tex. Once doctors are employed by hospitals, Medicare often pays higher rates for their services than it would pay to physicians for providing the same care in a private practice.

Indeed, the Federal Trade Commission has said the U.S. physician workplace is “undergoing a dramatic restructuring,” with traditional solo practices and small single-specialty group practices rapidly being replaced by large multispecialty physician group practices, or practices that are owned or employed by hospital systems. The FTC is in the midst of a major series of studies on the effects of this consolidation.

“There’s been so much market distortion, so much limitation in innovation by failing to adequately pay in the Physician Fee Schedule, that the consequence is the widespread consolidation,” said Dr. Wilson. “That’s recognized on both sides of the aisle as being essentially expensive and inefficient and not in patients’ best interest.”

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Don’t call me ‘Dr.,’ say some physicians – but most prefer the title

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Tue, 11/29/2022 - 13:26

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

 

 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

 

 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

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When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

 

 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

 

 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

 

 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

 

 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

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Skinny-label biosimilars provide substantial savings to Medicare

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Tue, 02/07/2023 - 16:37

Recent court rulings could put such saving under threat

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

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Recent court rulings could put such saving under threat

Recent court rulings could put such saving under threat

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

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Could this computer help you beat cancer?

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Changed
Wed, 11/23/2022 - 10:24

The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

 

 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

 

 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

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The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

 

 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

 

 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

 

 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

 

 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

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Are nurses who pick up extra shifts at risk of harming themselves or others?

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Wed, 11/23/2022 - 10:19

To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

 

 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

  • Salaried RNs and LPNs made more than hourly paid nurses.
  • In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
  • Specialty certifications helped RNs earn more money than nurses without specialty certificates.
  • Union RNs and LPNs earned more than nonunion nurses.
  • RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

  • Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
  • Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
  • Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
  • Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
  • Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

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To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

 

 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

  • Salaried RNs and LPNs made more than hourly paid nurses.
  • In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
  • Specialty certifications helped RNs earn more money than nurses without specialty certificates.
  • Union RNs and LPNs earned more than nonunion nurses.
  • RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

  • Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
  • Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
  • Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
  • Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
  • Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

 

 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

  • Salaried RNs and LPNs made more than hourly paid nurses.
  • In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
  • Specialty certifications helped RNs earn more money than nurses without specialty certificates.
  • Union RNs and LPNs earned more than nonunion nurses.
  • RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

  • Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
  • Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
  • Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
  • Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
  • Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

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Patient safety in hospitals improved in past decade: Report

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Mon, 11/28/2022 - 12:22

The patient safety record of U.S. hospitals improved over the past decade, according to the 10th annual report from nonprofit the Leapfrog Group, a national nonprofit organization focused on health care safety and quality.

For five outcome measures, the safety improvements saved an estimated 16,000 lives during the 10-year period, the report said. These included two “never” events that both declined by approximately 25%: incidents of falls and trauma and incidents of objects unintentionally left in a body after surgery.

There were also decreases in three health care–associated infections, including methicillin-resistant Staphylococcus aureus (MRSA), which decreased by 22%; central line–associated bloodstream infection (CLABSI), which fell by 43%; and Clostridioides difficile infection (C. Diff), which declined by 8%.

The patient safety record of U.S. hospitals improved over the past decade, according to the report.

“Never in history have we seen across-the-board improvement in patient safety until this last decade, coinciding with the history of the [Leapfrog] Hospital Safety Grade,” said Leah Binder, president and CEO of the Leapfrog Group, in a news release. “We salute hospitals for this milestone and encourage them to accelerate their hard work saving patient lives.”

During the past decade, the report noted, hospitals have widely adopted technology and staffing strategies that can protect patients from preventable harm and death. Leapfrog cited a nearly sevenfold increase in the adoption of computerized provider order entry, which can reduce medication errors by more than 40%. 

However, federal health officials separately have reported that the pandemic may have eroded some of those gains.

The Leapfrog report also cited a recent study, published in JAMA, that found that the rates of preventable adverse events in hospitalized patients – including adverse drug events, hospital-acquired infections, postprocedure events, and hospital-acquired pressure ulcers and falls – significantly declined between 2010 and 2019.

That study pointed to specific decreases in the rates of adverse events for patients admitted for myocardial infarction, heart failure, pneumonia, and major surgical procedures. There were also significant drops in adverse events for all other conditions, the study found.

Quality improvement efforts targeting those four conditions might have partly accounted for the lower rates of adverse events in patients with the conditions, the study observed. But “similar interventions did not occur for most of the conditions represented in the ‘all other conditions’ group,” it said.

In a 2019 report by the U.S. Agency for Healthcare Research and Quality (AHRQ), the agency noted that from 2000 to 2017, there had been gains in nearly two-thirds of patient-safety measures in acute, post-acute, and ambulatory care. Hospital safety improved on nine metrics and was unchanged on three. For example, from 2014 to 2017, the number of some hospital-acquired conditions, including adverse drug events and C. Diff infections, dropped about 20%.

However, in an article this past February, officials of the Centers for Medicare & Medicaid Services (CMS) said they had observed deterioration on multiple patient-safety metrics since the start of the pandemic. For example, central line infections, which had dropped by 31% in the five years before the COVID-19 outbreak, jumped 28% in the second quarter of 2020, compared with the prior-year period.

Commenting on these developments, the CMS authors said “the fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure.”

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

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The patient safety record of U.S. hospitals improved over the past decade, according to the 10th annual report from nonprofit the Leapfrog Group, a national nonprofit organization focused on health care safety and quality.

For five outcome measures, the safety improvements saved an estimated 16,000 lives during the 10-year period, the report said. These included two “never” events that both declined by approximately 25%: incidents of falls and trauma and incidents of objects unintentionally left in a body after surgery.

There were also decreases in three health care–associated infections, including methicillin-resistant Staphylococcus aureus (MRSA), which decreased by 22%; central line–associated bloodstream infection (CLABSI), which fell by 43%; and Clostridioides difficile infection (C. Diff), which declined by 8%.

The patient safety record of U.S. hospitals improved over the past decade, according to the report.

“Never in history have we seen across-the-board improvement in patient safety until this last decade, coinciding with the history of the [Leapfrog] Hospital Safety Grade,” said Leah Binder, president and CEO of the Leapfrog Group, in a news release. “We salute hospitals for this milestone and encourage them to accelerate their hard work saving patient lives.”

During the past decade, the report noted, hospitals have widely adopted technology and staffing strategies that can protect patients from preventable harm and death. Leapfrog cited a nearly sevenfold increase in the adoption of computerized provider order entry, which can reduce medication errors by more than 40%. 

However, federal health officials separately have reported that the pandemic may have eroded some of those gains.

The Leapfrog report also cited a recent study, published in JAMA, that found that the rates of preventable adverse events in hospitalized patients – including adverse drug events, hospital-acquired infections, postprocedure events, and hospital-acquired pressure ulcers and falls – significantly declined between 2010 and 2019.

That study pointed to specific decreases in the rates of adverse events for patients admitted for myocardial infarction, heart failure, pneumonia, and major surgical procedures. There were also significant drops in adverse events for all other conditions, the study found.

Quality improvement efforts targeting those four conditions might have partly accounted for the lower rates of adverse events in patients with the conditions, the study observed. But “similar interventions did not occur for most of the conditions represented in the ‘all other conditions’ group,” it said.

In a 2019 report by the U.S. Agency for Healthcare Research and Quality (AHRQ), the agency noted that from 2000 to 2017, there had been gains in nearly two-thirds of patient-safety measures in acute, post-acute, and ambulatory care. Hospital safety improved on nine metrics and was unchanged on three. For example, from 2014 to 2017, the number of some hospital-acquired conditions, including adverse drug events and C. Diff infections, dropped about 20%.

However, in an article this past February, officials of the Centers for Medicare & Medicaid Services (CMS) said they had observed deterioration on multiple patient-safety metrics since the start of the pandemic. For example, central line infections, which had dropped by 31% in the five years before the COVID-19 outbreak, jumped 28% in the second quarter of 2020, compared with the prior-year period.

Commenting on these developments, the CMS authors said “the fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure.”

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

The patient safety record of U.S. hospitals improved over the past decade, according to the 10th annual report from nonprofit the Leapfrog Group, a national nonprofit organization focused on health care safety and quality.

For five outcome measures, the safety improvements saved an estimated 16,000 lives during the 10-year period, the report said. These included two “never” events that both declined by approximately 25%: incidents of falls and trauma and incidents of objects unintentionally left in a body after surgery.

There were also decreases in three health care–associated infections, including methicillin-resistant Staphylococcus aureus (MRSA), which decreased by 22%; central line–associated bloodstream infection (CLABSI), which fell by 43%; and Clostridioides difficile infection (C. Diff), which declined by 8%.

The patient safety record of U.S. hospitals improved over the past decade, according to the report.

“Never in history have we seen across-the-board improvement in patient safety until this last decade, coinciding with the history of the [Leapfrog] Hospital Safety Grade,” said Leah Binder, president and CEO of the Leapfrog Group, in a news release. “We salute hospitals for this milestone and encourage them to accelerate their hard work saving patient lives.”

During the past decade, the report noted, hospitals have widely adopted technology and staffing strategies that can protect patients from preventable harm and death. Leapfrog cited a nearly sevenfold increase in the adoption of computerized provider order entry, which can reduce medication errors by more than 40%. 

However, federal health officials separately have reported that the pandemic may have eroded some of those gains.

The Leapfrog report also cited a recent study, published in JAMA, that found that the rates of preventable adverse events in hospitalized patients – including adverse drug events, hospital-acquired infections, postprocedure events, and hospital-acquired pressure ulcers and falls – significantly declined between 2010 and 2019.

That study pointed to specific decreases in the rates of adverse events for patients admitted for myocardial infarction, heart failure, pneumonia, and major surgical procedures. There were also significant drops in adverse events for all other conditions, the study found.

Quality improvement efforts targeting those four conditions might have partly accounted for the lower rates of adverse events in patients with the conditions, the study observed. But “similar interventions did not occur for most of the conditions represented in the ‘all other conditions’ group,” it said.

In a 2019 report by the U.S. Agency for Healthcare Research and Quality (AHRQ), the agency noted that from 2000 to 2017, there had been gains in nearly two-thirds of patient-safety measures in acute, post-acute, and ambulatory care. Hospital safety improved on nine metrics and was unchanged on three. For example, from 2014 to 2017, the number of some hospital-acquired conditions, including adverse drug events and C. Diff infections, dropped about 20%.

However, in an article this past February, officials of the Centers for Medicare & Medicaid Services (CMS) said they had observed deterioration on multiple patient-safety metrics since the start of the pandemic. For example, central line infections, which had dropped by 31% in the five years before the COVID-19 outbreak, jumped 28% in the second quarter of 2020, compared with the prior-year period.

Commenting on these developments, the CMS authors said “the fact that the pandemic degraded patient safety so quickly and severely suggests that our health care system lacks a sufficiently resilient safety culture and infrastructure.”

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

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