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FDA OKs first orally disintegrating agent for rapid migraine relief
In clinical testing, a single 75-mg dose of rimegepant provided rapid migraine pain relief with patients returning to normal activities within 1 hour, with sustained benefit lasting up to 2 days in many patients. The majority of patients (86%) treated with a single dose did not need a migraine rescue medication within 24 hours.
“I see many patients in my practice whose lives are disrupted by migraine, afraid to go about everyday life in case of a migraine attack,” Peter Goadsby, MD, PhD, professor of neurology and director of the King’s Clinical Research Facility, King’s College Hospital, London, UK, said in a news release from Biohaven.
“Many feel unsure if their acute treatment will work and if they can manage the side effects. With the FDA approval of Nurtec ODT, there is renewed hope for people living with migraine that they can get back to living their lives without fear of the next attack,” said Goadsby.
More than 3100 patients have been treated with rimegepant with more than 113,000 doses administered in clinical trials, including a 1-year long-term safety study, the company said.
In the phase 3 trial, rimegepant achieved statistical significance on the co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) 2 hours after administration compared with placebo.
Rimegepant also showed statistical superiority at 1 hour for pain relief (reduction of moderate or severe pain to no pain or mild pain) and return to normal function.
In many patients, the benefits of pain freedom, pain relief, return to normal function, and freedom from MBS with a single dose lasted up to 48 hours.
Rimegepant was generally well tolerated. The most common adverse reaction was nausea (2%) in patients who received rimegepant compared with 0.4% of patients who received placebo.
“Everyone knows someone living with migraine, yet it remains an invisible disease that is often overlooked and misunderstood,” Mary Franklin, executive director of the National Headache Foundation, commented in the news release.
“The approval of Nurtec ODT is exciting for people with migraine as it provides a new treatment option to help people regain control of their attacks and their lives,” said Franklin.
Nurtec ODT will be available in pharmacies in early March in packs of eight tablets. Each eight-tablet pack covers treatment of eight migraine attacks with one dose, as needed, up to once daily. Sample packs containing two tablets will also be made available to healthcare providers.
Rimegepant is not indicated for the preventive treatment of migraine. The company expects to report top-line results from its prevention of migraine trial later this quarter.
This story first appeared on Medscape.com.
In clinical testing, a single 75-mg dose of rimegepant provided rapid migraine pain relief with patients returning to normal activities within 1 hour, with sustained benefit lasting up to 2 days in many patients. The majority of patients (86%) treated with a single dose did not need a migraine rescue medication within 24 hours.
“I see many patients in my practice whose lives are disrupted by migraine, afraid to go about everyday life in case of a migraine attack,” Peter Goadsby, MD, PhD, professor of neurology and director of the King’s Clinical Research Facility, King’s College Hospital, London, UK, said in a news release from Biohaven.
“Many feel unsure if their acute treatment will work and if they can manage the side effects. With the FDA approval of Nurtec ODT, there is renewed hope for people living with migraine that they can get back to living their lives without fear of the next attack,” said Goadsby.
More than 3100 patients have been treated with rimegepant with more than 113,000 doses administered in clinical trials, including a 1-year long-term safety study, the company said.
In the phase 3 trial, rimegepant achieved statistical significance on the co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) 2 hours after administration compared with placebo.
Rimegepant also showed statistical superiority at 1 hour for pain relief (reduction of moderate or severe pain to no pain or mild pain) and return to normal function.
In many patients, the benefits of pain freedom, pain relief, return to normal function, and freedom from MBS with a single dose lasted up to 48 hours.
Rimegepant was generally well tolerated. The most common adverse reaction was nausea (2%) in patients who received rimegepant compared with 0.4% of patients who received placebo.
“Everyone knows someone living with migraine, yet it remains an invisible disease that is often overlooked and misunderstood,” Mary Franklin, executive director of the National Headache Foundation, commented in the news release.
“The approval of Nurtec ODT is exciting for people with migraine as it provides a new treatment option to help people regain control of their attacks and their lives,” said Franklin.
Nurtec ODT will be available in pharmacies in early March in packs of eight tablets. Each eight-tablet pack covers treatment of eight migraine attacks with one dose, as needed, up to once daily. Sample packs containing two tablets will also be made available to healthcare providers.
Rimegepant is not indicated for the preventive treatment of migraine. The company expects to report top-line results from its prevention of migraine trial later this quarter.
This story first appeared on Medscape.com.
In clinical testing, a single 75-mg dose of rimegepant provided rapid migraine pain relief with patients returning to normal activities within 1 hour, with sustained benefit lasting up to 2 days in many patients. The majority of patients (86%) treated with a single dose did not need a migraine rescue medication within 24 hours.
“I see many patients in my practice whose lives are disrupted by migraine, afraid to go about everyday life in case of a migraine attack,” Peter Goadsby, MD, PhD, professor of neurology and director of the King’s Clinical Research Facility, King’s College Hospital, London, UK, said in a news release from Biohaven.
“Many feel unsure if their acute treatment will work and if they can manage the side effects. With the FDA approval of Nurtec ODT, there is renewed hope for people living with migraine that they can get back to living their lives without fear of the next attack,” said Goadsby.
More than 3100 patients have been treated with rimegepant with more than 113,000 doses administered in clinical trials, including a 1-year long-term safety study, the company said.
In the phase 3 trial, rimegepant achieved statistical significance on the co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) 2 hours after administration compared with placebo.
Rimegepant also showed statistical superiority at 1 hour for pain relief (reduction of moderate or severe pain to no pain or mild pain) and return to normal function.
In many patients, the benefits of pain freedom, pain relief, return to normal function, and freedom from MBS with a single dose lasted up to 48 hours.
Rimegepant was generally well tolerated. The most common adverse reaction was nausea (2%) in patients who received rimegepant compared with 0.4% of patients who received placebo.
“Everyone knows someone living with migraine, yet it remains an invisible disease that is often overlooked and misunderstood,” Mary Franklin, executive director of the National Headache Foundation, commented in the news release.
“The approval of Nurtec ODT is exciting for people with migraine as it provides a new treatment option to help people regain control of their attacks and their lives,” said Franklin.
Nurtec ODT will be available in pharmacies in early March in packs of eight tablets. Each eight-tablet pack covers treatment of eight migraine attacks with one dose, as needed, up to once daily. Sample packs containing two tablets will also be made available to healthcare providers.
Rimegepant is not indicated for the preventive treatment of migraine. The company expects to report top-line results from its prevention of migraine trial later this quarter.
This story first appeared on Medscape.com.
Rising number of young people dying after heavy drinking
MAUI, HAWAII – Alcohol use and deaths related to alcohol-use disorders are increasing, and young adults might be the group to watch, said Norah Terrault, MD, MPH, professor at the Keck School of Medicine of USC in Los Angeles.
“A lot of young people are drinking large amounts and they don’t know they’re at risk. They may not drink much during the week but then drink 30 drinks on the weekend,” Dr. Terrault told Medscape Medical News.
The largest relative increase in deaths from alcoholic cirrhosis – 10.5% from 2009 to 2016 – was in the 25- to 34-year age group, she reported here at the Gastroenterology Updates IBD Liver Disease Conference 2020.
This highlights the importance of asking for details about alcohol use during primary care visits; not only how much, but also what time of day, for instance, she explained.
Dr. Terrault’s team at Keck is part of the ACCELERATE-AH consortium, a group of 12 transplant centers looking at patterns of alcohol use before and after liver transplantation.
In their retrospective study of 147 consecutive transplant patients from 2006 to 2018, they found that young age, a history of multiple rehab attempts, and overt encephalopathy at time of transplantation were predictors of alcohol use after the procedure.
Corticosteroids remain the only proven therapy for alcoholic hepatitis. “We have not seen a new therapy in this arena in decades,” said Dr. Terrault. “We really have nothing to offer these patients, yet it’s an incredibly common presentation with a high mortality.”
More treatment options
The good news is that some phase 2 data look promising for new therapies, she reported.
“Some of them are targeting injury and regeneration primarily. Others are looking at the anti-inflammatory and antifibrotic effects. Some are also looking at how gut permeability and the microbiome are influencing outcomes,” she explained.
Transplantation has become very important for patients who do not respond to current therapy, and selection criteria have evolved over the years to take this into account, she pointed out.
In the early 1980s, alcoholic hepatitis was considered an inappropriate indication for liver transplantation. In the early 2000s, the guidance moved to setting 6 months of alcohol abstinence as a criterion for transplantation. The 6-month rule effectively eliminated patients with severe alcoholic hepatitis, who, by the time they needed a new liver, would not have 6 months to live.
Recently, guidelines have added the option of transplantation for patients with alcoholic hepatitis. The option was always there for people who developed alcohol cirrhosis or liver cancer, but now alcoholic hepatitis is recognized as a potential indication for transplantation, Dr. Terrault explained.
Today, transplant centers are moving away from the 6-month rule for two main reasons, she said. One is that few data support the 6-month time period as the duration that makes a difference.
“There is nothing magical about 6 months vs. 3 months or 12 months,” she said, adding that studies have shown that other factors might be better indicators, such as family support and whether the person is employed.
Second, recent studies have shown that rates of 3-year survival are similar in people who did not abstain at all before the procedure and those who undergo transplantation for other reasons.
The ACCELERATE-AH consortium also found that 70% of patients with severe alcoholic hepatitis remained abstinent up to 3 years after transplantation.
Anytime we give an organ to anyone on the list, someone else may die without one. Every year, 20% of patients on the list die without a transplant.
The selection process remains complicated and controversial, Dr. Terrault acknowledged.
“Anytime we give an organ to anyone on the list, someone else may die without one. Every year, 20% of patients on the list die without a transplant,” she said.
And there is concern that because patients with severe alcoholic hepatitis present with severe illness, they get moved to the top of the wait list. The rationale for that, she explained, is that it is done that way in other acute situations.
“We transplant individuals who have an acetaminophen overdose, for example. That’s common in many programs,” she said.
“My issue is that some patients with acute alcoholic hepatitis that have a very high severity score, but some of them, just with abstinence, will get better,” said Guadalupe Garcia-Tsao, MD, professor of medicine at Yale University in New Haven, Conn.
There are cases in which acute alcoholic hepatitis will resolve with abstinence, “and patients can return to an entirely compensated state of cirrhosis, in which they are entirely asymptomatic and they can live,” she told Medscape Medical News.
But it’s hard to know without a control group which patients would have that kind of success with just abstinence, she acknowledged.
Terrault said she agreed, and added that “our tools are not that good,” so determining which patients can be “pulled back from the brink” without transplantation is a challenge.
“There’s still a lot to learn about how we do this, and how we do it well,” she said.
Alcoholic hepatitis as an indication for liver transplantation is rare – less than 1% – but growing.
“This is a potential therapy for your patient who is sick in the ICU with a high severity of disease who has failed steroids. We should call out to see if there’s a transplant program that might be willing to evaluate them,” she said.
This article first appeared on Medscape.com.
MAUI, HAWAII – Alcohol use and deaths related to alcohol-use disorders are increasing, and young adults might be the group to watch, said Norah Terrault, MD, MPH, professor at the Keck School of Medicine of USC in Los Angeles.
“A lot of young people are drinking large amounts and they don’t know they’re at risk. They may not drink much during the week but then drink 30 drinks on the weekend,” Dr. Terrault told Medscape Medical News.
The largest relative increase in deaths from alcoholic cirrhosis – 10.5% from 2009 to 2016 – was in the 25- to 34-year age group, she reported here at the Gastroenterology Updates IBD Liver Disease Conference 2020.
This highlights the importance of asking for details about alcohol use during primary care visits; not only how much, but also what time of day, for instance, she explained.
Dr. Terrault’s team at Keck is part of the ACCELERATE-AH consortium, a group of 12 transplant centers looking at patterns of alcohol use before and after liver transplantation.
In their retrospective study of 147 consecutive transplant patients from 2006 to 2018, they found that young age, a history of multiple rehab attempts, and overt encephalopathy at time of transplantation were predictors of alcohol use after the procedure.
Corticosteroids remain the only proven therapy for alcoholic hepatitis. “We have not seen a new therapy in this arena in decades,” said Dr. Terrault. “We really have nothing to offer these patients, yet it’s an incredibly common presentation with a high mortality.”
More treatment options
The good news is that some phase 2 data look promising for new therapies, she reported.
“Some of them are targeting injury and regeneration primarily. Others are looking at the anti-inflammatory and antifibrotic effects. Some are also looking at how gut permeability and the microbiome are influencing outcomes,” she explained.
Transplantation has become very important for patients who do not respond to current therapy, and selection criteria have evolved over the years to take this into account, she pointed out.
In the early 1980s, alcoholic hepatitis was considered an inappropriate indication for liver transplantation. In the early 2000s, the guidance moved to setting 6 months of alcohol abstinence as a criterion for transplantation. The 6-month rule effectively eliminated patients with severe alcoholic hepatitis, who, by the time they needed a new liver, would not have 6 months to live.
Recently, guidelines have added the option of transplantation for patients with alcoholic hepatitis. The option was always there for people who developed alcohol cirrhosis or liver cancer, but now alcoholic hepatitis is recognized as a potential indication for transplantation, Dr. Terrault explained.
Today, transplant centers are moving away from the 6-month rule for two main reasons, she said. One is that few data support the 6-month time period as the duration that makes a difference.
“There is nothing magical about 6 months vs. 3 months or 12 months,” she said, adding that studies have shown that other factors might be better indicators, such as family support and whether the person is employed.
Second, recent studies have shown that rates of 3-year survival are similar in people who did not abstain at all before the procedure and those who undergo transplantation for other reasons.
The ACCELERATE-AH consortium also found that 70% of patients with severe alcoholic hepatitis remained abstinent up to 3 years after transplantation.
Anytime we give an organ to anyone on the list, someone else may die without one. Every year, 20% of patients on the list die without a transplant.
The selection process remains complicated and controversial, Dr. Terrault acknowledged.
“Anytime we give an organ to anyone on the list, someone else may die without one. Every year, 20% of patients on the list die without a transplant,” she said.
And there is concern that because patients with severe alcoholic hepatitis present with severe illness, they get moved to the top of the wait list. The rationale for that, she explained, is that it is done that way in other acute situations.
“We transplant individuals who have an acetaminophen overdose, for example. That’s common in many programs,” she said.
“My issue is that some patients with acute alcoholic hepatitis that have a very high severity score, but some of them, just with abstinence, will get better,” said Guadalupe Garcia-Tsao, MD, professor of medicine at Yale University in New Haven, Conn.
There are cases in which acute alcoholic hepatitis will resolve with abstinence, “and patients can return to an entirely compensated state of cirrhosis, in which they are entirely asymptomatic and they can live,” she told Medscape Medical News.
But it’s hard to know without a control group which patients would have that kind of success with just abstinence, she acknowledged.
Terrault said she agreed, and added that “our tools are not that good,” so determining which patients can be “pulled back from the brink” without transplantation is a challenge.
“There’s still a lot to learn about how we do this, and how we do it well,” she said.
Alcoholic hepatitis as an indication for liver transplantation is rare – less than 1% – but growing.
“This is a potential therapy for your patient who is sick in the ICU with a high severity of disease who has failed steroids. We should call out to see if there’s a transplant program that might be willing to evaluate them,” she said.
This article first appeared on Medscape.com.
MAUI, HAWAII – Alcohol use and deaths related to alcohol-use disorders are increasing, and young adults might be the group to watch, said Norah Terrault, MD, MPH, professor at the Keck School of Medicine of USC in Los Angeles.
“A lot of young people are drinking large amounts and they don’t know they’re at risk. They may not drink much during the week but then drink 30 drinks on the weekend,” Dr. Terrault told Medscape Medical News.
The largest relative increase in deaths from alcoholic cirrhosis – 10.5% from 2009 to 2016 – was in the 25- to 34-year age group, she reported here at the Gastroenterology Updates IBD Liver Disease Conference 2020.
This highlights the importance of asking for details about alcohol use during primary care visits; not only how much, but also what time of day, for instance, she explained.
Dr. Terrault’s team at Keck is part of the ACCELERATE-AH consortium, a group of 12 transplant centers looking at patterns of alcohol use before and after liver transplantation.
In their retrospective study of 147 consecutive transplant patients from 2006 to 2018, they found that young age, a history of multiple rehab attempts, and overt encephalopathy at time of transplantation were predictors of alcohol use after the procedure.
Corticosteroids remain the only proven therapy for alcoholic hepatitis. “We have not seen a new therapy in this arena in decades,” said Dr. Terrault. “We really have nothing to offer these patients, yet it’s an incredibly common presentation with a high mortality.”
More treatment options
The good news is that some phase 2 data look promising for new therapies, she reported.
“Some of them are targeting injury and regeneration primarily. Others are looking at the anti-inflammatory and antifibrotic effects. Some are also looking at how gut permeability and the microbiome are influencing outcomes,” she explained.
Transplantation has become very important for patients who do not respond to current therapy, and selection criteria have evolved over the years to take this into account, she pointed out.
In the early 1980s, alcoholic hepatitis was considered an inappropriate indication for liver transplantation. In the early 2000s, the guidance moved to setting 6 months of alcohol abstinence as a criterion for transplantation. The 6-month rule effectively eliminated patients with severe alcoholic hepatitis, who, by the time they needed a new liver, would not have 6 months to live.
Recently, guidelines have added the option of transplantation for patients with alcoholic hepatitis. The option was always there for people who developed alcohol cirrhosis or liver cancer, but now alcoholic hepatitis is recognized as a potential indication for transplantation, Dr. Terrault explained.
Today, transplant centers are moving away from the 6-month rule for two main reasons, she said. One is that few data support the 6-month time period as the duration that makes a difference.
“There is nothing magical about 6 months vs. 3 months or 12 months,” she said, adding that studies have shown that other factors might be better indicators, such as family support and whether the person is employed.
Second, recent studies have shown that rates of 3-year survival are similar in people who did not abstain at all before the procedure and those who undergo transplantation for other reasons.
The ACCELERATE-AH consortium also found that 70% of patients with severe alcoholic hepatitis remained abstinent up to 3 years after transplantation.
Anytime we give an organ to anyone on the list, someone else may die without one. Every year, 20% of patients on the list die without a transplant.
The selection process remains complicated and controversial, Dr. Terrault acknowledged.
“Anytime we give an organ to anyone on the list, someone else may die without one. Every year, 20% of patients on the list die without a transplant,” she said.
And there is concern that because patients with severe alcoholic hepatitis present with severe illness, they get moved to the top of the wait list. The rationale for that, she explained, is that it is done that way in other acute situations.
“We transplant individuals who have an acetaminophen overdose, for example. That’s common in many programs,” she said.
“My issue is that some patients with acute alcoholic hepatitis that have a very high severity score, but some of them, just with abstinence, will get better,” said Guadalupe Garcia-Tsao, MD, professor of medicine at Yale University in New Haven, Conn.
There are cases in which acute alcoholic hepatitis will resolve with abstinence, “and patients can return to an entirely compensated state of cirrhosis, in which they are entirely asymptomatic and they can live,” she told Medscape Medical News.
But it’s hard to know without a control group which patients would have that kind of success with just abstinence, she acknowledged.
Terrault said she agreed, and added that “our tools are not that good,” so determining which patients can be “pulled back from the brink” without transplantation is a challenge.
“There’s still a lot to learn about how we do this, and how we do it well,” she said.
Alcoholic hepatitis as an indication for liver transplantation is rare – less than 1% – but growing.
“This is a potential therapy for your patient who is sick in the ICU with a high severity of disease who has failed steroids. We should call out to see if there’s a transplant program that might be willing to evaluate them,” she said.
This article first appeared on Medscape.com.
EXPERT ANALYSIS FROM GUILD 2020
Are patient portals living up to the hype? Ask your mother-in-law!
While preparing to write this technology column, I received a great deal of insight from the unlikeliest of sources: my mother-in-law.
Now don’t get me wrong – she’s a truly lovely, intelligent, and capable woman. I have sought her advice often on many things and have always been impressed by her wisdom and pragmatism, but I’ve just never thought of asking her for her opinion on medicine or technology, as I considered her knowledge of both subjects to be limited.
This occasion changed my opinion. In fact, I believe that, as health care IT becomes more complex, people like my mother-in-law may be exactly who we should be looking to for answers.
A few weeks ago, my mother-in-law and I were discussing her recent trip to the doctor. When she mentioned some lab tests, I suggested that we log in to her patient portal to view the results. This elicited several questions and a declaration of frustration.
“Which portal?” she asked. “I have so many and can’t keep all of the websites and passwords straight! Why can’t all of my doctors use the same portal, and why do they all have different password requirements?”
As she spoke these words, I was immediately struck with an unfortunate reality of EHRs: We have done a brilliant job creating state-of-the-art digital castles and have filled them with the data needed to revolutionize care and improve population health – but we haven’t given our patients the keys to get inside.
We must ask ourselves if, in trying to construct fortresses of information around our patients, we have lost sight of the individuals in the center. I believe that we can answer this question and improve the benefits of patient portals, but we all must agree to a few simple steps to streamline the experience for everyone.
Make it easy
A study recently published in the Journal of General Internal Medicine surveyed several hospitals on their usage of patient portals. After determining whether or not the institutions had such portals, the authors then investigated to find out what, if any, guidance was provided to patients about how to use them.
Their findings are frustrating, though not surprising. While 89% of hospitals had some form of patient portal, only 65% of those “had links that were easily found, defined as links accessible within two clicks from the home page.”
Furthermore, even in cases where portals were easily found, good instructions on how to use them were missing. Those instructions that did exist centered on rules and restrictions and laying out “terms and conditions” and informing patients on “what not to do,” rather than explaining how to make the most of the experience.
According to the authors, “this focus on curtailing behavior, and the hurdles placed on finding and understanding guidance, suggest that some hospitals may be prioritizing reducing liability over improving the patient experience with portals.”
If we want our patients to use them, portals must be easy to access and intuitive to use. They also must provide value.
Make it meaningful
Patient portals have proliferated exponentially over the last 10 years, thanks to government incentive programs. One such program, known as “meaningful use,” is primarily responsible for this, as it made implementation of a patient portal one of its core requirements.
Sadly, in spite of its oft-reviled name, the meaningful use program never defined patient-friendly standards of usability for patient portals. As a result, current portals just aren’t very good. Patients like my mother-in-law find them to be too numerous, too unfriendly to use, and too limited, so they are not being used to their full potential.
In fact, many institutions may choose not to enable all of the available features in order to limit technical issues and reduce the burden on providers. In the study referenced above, only 63% of portals offered the ability for patients to communicate directly with their physicians, and only 43% offered the ability to refill prescriptions.
When enabled, these functions improve patient engagement and efficiency. Without them, patients are less likely to log on, and physicians are forced to rely on less-efficient telephone calls or traditional letters to communicate results to their patients.
Put the patient, not the portal, at the center
History has all but forgotten the attempts by tech giants such as Google and Microsoft to create personal health records. While these initially seemed like a wonderful concept, they sadly proved to be a total flop. Some patients embraced the idea, but security concerns and the lack of buy-in from EHR vendors significantly limited their uptake.
They may simply have been ahead of their time.
A decade later, wearable technology and telemedicine are ushering in a new era of patient-centric care. Individuals have been embracing a greater share of the responsibility for their own personal health information, yet most EHRs lack the ability to easily incorporate data acquired outside physicians’ offices.
It’s time for EHR vendors to go all in and change that. Instead of enslaving patients to the tyranny of fragmented health records, they should prioritize the creation of a robust, standardized, and portable health record that travels with the patient, not the other way around.
Have any other ideas on how to improve patient engagement? We’d love to hear about them and share them in a future column.
If you want to contribute but don’t have any ideas, we have a suggestion: Ask your mother-in-law. You may be surprised at what you learn!
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Hospital–Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.
Reference
Lee JL et al. J Gen Intern Med. 2019 Nov 12. doi: 10.1007/s11606-019-05528-z.
While preparing to write this technology column, I received a great deal of insight from the unlikeliest of sources: my mother-in-law.
Now don’t get me wrong – she’s a truly lovely, intelligent, and capable woman. I have sought her advice often on many things and have always been impressed by her wisdom and pragmatism, but I’ve just never thought of asking her for her opinion on medicine or technology, as I considered her knowledge of both subjects to be limited.
This occasion changed my opinion. In fact, I believe that, as health care IT becomes more complex, people like my mother-in-law may be exactly who we should be looking to for answers.
A few weeks ago, my mother-in-law and I were discussing her recent trip to the doctor. When she mentioned some lab tests, I suggested that we log in to her patient portal to view the results. This elicited several questions and a declaration of frustration.
“Which portal?” she asked. “I have so many and can’t keep all of the websites and passwords straight! Why can’t all of my doctors use the same portal, and why do they all have different password requirements?”
As she spoke these words, I was immediately struck with an unfortunate reality of EHRs: We have done a brilliant job creating state-of-the-art digital castles and have filled them with the data needed to revolutionize care and improve population health – but we haven’t given our patients the keys to get inside.
We must ask ourselves if, in trying to construct fortresses of information around our patients, we have lost sight of the individuals in the center. I believe that we can answer this question and improve the benefits of patient portals, but we all must agree to a few simple steps to streamline the experience for everyone.
Make it easy
A study recently published in the Journal of General Internal Medicine surveyed several hospitals on their usage of patient portals. After determining whether or not the institutions had such portals, the authors then investigated to find out what, if any, guidance was provided to patients about how to use them.
Their findings are frustrating, though not surprising. While 89% of hospitals had some form of patient portal, only 65% of those “had links that were easily found, defined as links accessible within two clicks from the home page.”
Furthermore, even in cases where portals were easily found, good instructions on how to use them were missing. Those instructions that did exist centered on rules and restrictions and laying out “terms and conditions” and informing patients on “what not to do,” rather than explaining how to make the most of the experience.
According to the authors, “this focus on curtailing behavior, and the hurdles placed on finding and understanding guidance, suggest that some hospitals may be prioritizing reducing liability over improving the patient experience with portals.”
If we want our patients to use them, portals must be easy to access and intuitive to use. They also must provide value.
Make it meaningful
Patient portals have proliferated exponentially over the last 10 years, thanks to government incentive programs. One such program, known as “meaningful use,” is primarily responsible for this, as it made implementation of a patient portal one of its core requirements.
Sadly, in spite of its oft-reviled name, the meaningful use program never defined patient-friendly standards of usability for patient portals. As a result, current portals just aren’t very good. Patients like my mother-in-law find them to be too numerous, too unfriendly to use, and too limited, so they are not being used to their full potential.
In fact, many institutions may choose not to enable all of the available features in order to limit technical issues and reduce the burden on providers. In the study referenced above, only 63% of portals offered the ability for patients to communicate directly with their physicians, and only 43% offered the ability to refill prescriptions.
When enabled, these functions improve patient engagement and efficiency. Without them, patients are less likely to log on, and physicians are forced to rely on less-efficient telephone calls or traditional letters to communicate results to their patients.
Put the patient, not the portal, at the center
History has all but forgotten the attempts by tech giants such as Google and Microsoft to create personal health records. While these initially seemed like a wonderful concept, they sadly proved to be a total flop. Some patients embraced the idea, but security concerns and the lack of buy-in from EHR vendors significantly limited their uptake.
They may simply have been ahead of their time.
A decade later, wearable technology and telemedicine are ushering in a new era of patient-centric care. Individuals have been embracing a greater share of the responsibility for their own personal health information, yet most EHRs lack the ability to easily incorporate data acquired outside physicians’ offices.
It’s time for EHR vendors to go all in and change that. Instead of enslaving patients to the tyranny of fragmented health records, they should prioritize the creation of a robust, standardized, and portable health record that travels with the patient, not the other way around.
Have any other ideas on how to improve patient engagement? We’d love to hear about them and share them in a future column.
If you want to contribute but don’t have any ideas, we have a suggestion: Ask your mother-in-law. You may be surprised at what you learn!
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Hospital–Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.
Reference
Lee JL et al. J Gen Intern Med. 2019 Nov 12. doi: 10.1007/s11606-019-05528-z.
While preparing to write this technology column, I received a great deal of insight from the unlikeliest of sources: my mother-in-law.
Now don’t get me wrong – she’s a truly lovely, intelligent, and capable woman. I have sought her advice often on many things and have always been impressed by her wisdom and pragmatism, but I’ve just never thought of asking her for her opinion on medicine or technology, as I considered her knowledge of both subjects to be limited.
This occasion changed my opinion. In fact, I believe that, as health care IT becomes more complex, people like my mother-in-law may be exactly who we should be looking to for answers.
A few weeks ago, my mother-in-law and I were discussing her recent trip to the doctor. When she mentioned some lab tests, I suggested that we log in to her patient portal to view the results. This elicited several questions and a declaration of frustration.
“Which portal?” she asked. “I have so many and can’t keep all of the websites and passwords straight! Why can’t all of my doctors use the same portal, and why do they all have different password requirements?”
As she spoke these words, I was immediately struck with an unfortunate reality of EHRs: We have done a brilliant job creating state-of-the-art digital castles and have filled them with the data needed to revolutionize care and improve population health – but we haven’t given our patients the keys to get inside.
We must ask ourselves if, in trying to construct fortresses of information around our patients, we have lost sight of the individuals in the center. I believe that we can answer this question and improve the benefits of patient portals, but we all must agree to a few simple steps to streamline the experience for everyone.
Make it easy
A study recently published in the Journal of General Internal Medicine surveyed several hospitals on their usage of patient portals. After determining whether or not the institutions had such portals, the authors then investigated to find out what, if any, guidance was provided to patients about how to use them.
Their findings are frustrating, though not surprising. While 89% of hospitals had some form of patient portal, only 65% of those “had links that were easily found, defined as links accessible within two clicks from the home page.”
Furthermore, even in cases where portals were easily found, good instructions on how to use them were missing. Those instructions that did exist centered on rules and restrictions and laying out “terms and conditions” and informing patients on “what not to do,” rather than explaining how to make the most of the experience.
According to the authors, “this focus on curtailing behavior, and the hurdles placed on finding and understanding guidance, suggest that some hospitals may be prioritizing reducing liability over improving the patient experience with portals.”
If we want our patients to use them, portals must be easy to access and intuitive to use. They also must provide value.
Make it meaningful
Patient portals have proliferated exponentially over the last 10 years, thanks to government incentive programs. One such program, known as “meaningful use,” is primarily responsible for this, as it made implementation of a patient portal one of its core requirements.
Sadly, in spite of its oft-reviled name, the meaningful use program never defined patient-friendly standards of usability for patient portals. As a result, current portals just aren’t very good. Patients like my mother-in-law find them to be too numerous, too unfriendly to use, and too limited, so they are not being used to their full potential.
In fact, many institutions may choose not to enable all of the available features in order to limit technical issues and reduce the burden on providers. In the study referenced above, only 63% of portals offered the ability for patients to communicate directly with their physicians, and only 43% offered the ability to refill prescriptions.
When enabled, these functions improve patient engagement and efficiency. Without them, patients are less likely to log on, and physicians are forced to rely on less-efficient telephone calls or traditional letters to communicate results to their patients.
Put the patient, not the portal, at the center
History has all but forgotten the attempts by tech giants such as Google and Microsoft to create personal health records. While these initially seemed like a wonderful concept, they sadly proved to be a total flop. Some patients embraced the idea, but security concerns and the lack of buy-in from EHR vendors significantly limited their uptake.
They may simply have been ahead of their time.
A decade later, wearable technology and telemedicine are ushering in a new era of patient-centric care. Individuals have been embracing a greater share of the responsibility for their own personal health information, yet most EHRs lack the ability to easily incorporate data acquired outside physicians’ offices.
It’s time for EHR vendors to go all in and change that. Instead of enslaving patients to the tyranny of fragmented health records, they should prioritize the creation of a robust, standardized, and portable health record that travels with the patient, not the other way around.
Have any other ideas on how to improve patient engagement? We’d love to hear about them and share them in a future column.
If you want to contribute but don’t have any ideas, we have a suggestion: Ask your mother-in-law. You may be surprised at what you learn!
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Hospital–Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.
Reference
Lee JL et al. J Gen Intern Med. 2019 Nov 12. doi: 10.1007/s11606-019-05528-z.
Diagnosing insomnia takes time
Give new patients 1 hour, expert advises
LAS VEGAS – Clinicians should spend 1 hour with patients who present with a chief complaint of insomnia, rather than rushing to a treatment after a 10- to 15-minute office visit, according to John W. Winkelman, MD, PhD.
“Why? Because sleep problems are usually multifactorial, involving psychiatric illness, sleep disorders, medical illness, medication, and poor sleep hygiene/stress,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “There are usually many contributing problems, and sleep quality is only as strong as the weakest link. Maybe you don’t have an hour [to meet with new patients], but you need to give adequate time, otherwise you’re not going to do justice to the problem.”
“Ask, ‘what is it that bothers you most about your insomnia? Is it the time awake at night, your total sleep time, or how you feel during the day?’ Because we’re going to use different approaches based on that chief complaint of the insomnia,” said Dr. Winkelman, chief of the Massachusetts General Sleep Disorders Clinical Research Program in the department of psychiatry at Harvard Medical School, Boston. “Cognitive-behavioral therapy for insomnia [CBT-I], for instance, is very good at reducing time awake at night. It won’t increase total sleep time, but it reduces time awake at night dramatically.”
According to the DSM-5, insomnia disorder is marked by dissatisfaction with sleep quality or quantity associated with at least one of the following: difficulty initiating sleep, difficulty maintaining sleep, and early morning awakening. “Just getting up to pee five times a night is not insomnia,” he said. “Just taking an hour and a half to fall asleep at the beginning of the night is not insomnia. There has to be distress or dysfunction related to the sleep disturbance, for a minimum of three times per week for 3 months.”
Most sleep problems are transient, but 25%-30% last more than 1 year. The differential diagnosis for chronic insomnia includes primary psychiatric disorders, medications, substances, restless legs syndrome, sleep schedule disorders, and obstructive sleep apnea.
“In general, we do not order sleep studies in people with insomnia unless we suspect sleep apnea; it’s just a waste of time,” said Dr. Winkelman, who is also a professor of psychiatry at Harvard Medical School. Indications for polysomnography include loud snoring plus one of the following: daytime sleepiness, witnessed apneas, or refractory hypertension. Other indications include abnormal behaviors or movements during sleep, unexplained excessive daytime sleepiness, and refractory sleep complaints, especially repetitive brief awakenings.
Many common cognitive and behavioral issues can produce or worsen insomnia, including inconsistent bedtimes and wake times. “That irregular schedule wreaks havoc with sleep,” he said. “It messes up the circadian rhythm. Also, homeostatic drive needs to build up: We need to be awake 16 or more hours in order to be sleepy. If people are sleeping until noon on Sundays and then trying to go to bed at their usual time, 10 or 11 at night, they’ve only been awake 10 or 11 hours. That’s why they’re going to have problems falling asleep. Also, a lot of people doze off after dinner in front of the TV. That doesn’t help.”
Spending excessive time in bed can also trigger or worsen insomnia. Dr. Winkelman recommends that people restrict their access to bed to the number of hours it is reasonable to sleep. “I see a lot of people in their 70s and 80s spending 10 hours in bed,” he said. “It doesn’t sound that crazy, but there is no way they’re going to get 10 hours of sleep. It’s physically impossible, so they spend 2 or 3 hours awake at night.” Clock-watching is another no-no. “In the middle of the night you wake up, look at the clock, and say to yourself: ‘Oh my god, I’ve been awake for 3 hours. I have 4 hours left. I need 7 hours. That means I need to go to sleep now!’ ”
An estimated 30%-40% of people with chronic insomnia have a psychiatric disorder. That means “you have to be thorough in your evaluation and act as if you’re doing a structured interview,” Dr. Winkelman said. “Ask about obsessive-compulsive disorder, generalized anxiety disorder, PTSD, et cetera, so that you understand the complete myriad of psychiatric illnesses, because psychiatric illnesses run in gangs. Comorbidity is generally the rule.”
The first-line treatment for chronic insomnia disorder is CBT-I, a multicomponent approach that includes time-in-bed restriction, stimulus control, cognitive therapy, relaxation therapy, and sleep hygiene. According to Dr. Winkelman, the cornerstone of CBT-I is time-in-bed restriction. “Many people with insomnia are spending 8.5 hours in bed to get 6.5 hours of sleep,” he said. “What you do is restrict access to bed to 6.5 hours; you initially sleep deprive them. Over the first few weeks, they hate you. After a few weeks when they start sleeping well, you start gradually increasing time in bed, but they rarely get back to the 8.5 hours in bed they were spending beforehand.”
Online CBT-I programs such as Sleepio can also be effective for improving sleep latency and wake after sleep onset, but not for total sleep time (JAMA Psychiatry. 2017;74[1]:68-75). “Not everybody responds to CBT; 50% don’t respond at a couple of months,” he said. “These are the people you need to think about medication for.”
Medications commonly used for chronic insomnia include benzodiazepine receptor agonists (BzRAs) – temazepam, eszopiclone, triazolam, zolpidem, and zaleplon are Food and Drug Administration approved – melatonin agonists, orexin antagonists, sedating antidepressants, anticonvulsants, and dopaminergic antagonists. “Each of the agents in these categories has somewhat similar mechanisms of action, and similar efficacy and contraindications,” Dr. Winkelman said. “The best way to divide the benzodiazepine receptor agonists is based on half-life. How long do you want drug on receptor in somebody with insomnia? Probably not much longer than 8 hours. Nevertheless, some psychiatrists love clonazepam, which has a 40-hour half-life. The circumstances under which clonazepam should be used for insomnia are small, such as in people with a daytime anxiety disorder.”
Consider trying triazolam, zolpidem, and zaleplon for patients who have problems falling asleep, he said, while oxazepam and eszopiclone are sensible options for people who have difficulty falling and staying asleep. Clinical response to BzRAs is common, yet only about half of people who have insomnia remit with one of these agents.
Dr. Winkelman said that patients and physicians often ask him whether BzRAs and other agents used as sleep aids are addictive. Abuse is identified when recurrent use causes clinically and functionally significant impairment, such as health problems; disability; and failure to meet major responsibilities at work, home, or school. “These are concerns with BzRAs. Misuse and abuse generally occur in younger people. Once you get to 35 years old, misuse rates get very low. In older people, rates of side effects go up.
“Tolerance, physiological and psychological dependence, and nonmedical diversion are also of concern,” he said. However, for the majority of people, BzRA hypnotics are effective and safe.
As for other agents, meta-analyses have demonstrated that melatonin 1-3 mg can help people fall asleep when it’s not being endogenously released. “That’s during the day,” he said. “That might be most relevant for jet lag and for people doing shift work.” Two orexin antagonists on the market for insomnia include suvorexant and lemborexant 10-20 mg. Advantages of these include little abuse liability and few side effects. “In one head-to-head polysomnography study in the elderly, lemborexant was superior to zolpidem 6.25 mg CR on both objective and subjective ability to fall asleep and stay asleep,” Dr. Winkelman said. (JAMA Netw Open. 2019;2[12]:e1918254).
Antidepressants are another treatment option, including mirtazapine 15-30 mg, trazodone 25-100 mg, and amitriptyline and doxepin (10-50 mg). Advantages include little abuse liability, while potential drawbacks include daytime sedation, weight gain, and anticholinergic side effects. Meanwhile, atypical antipsychotics such as quetiapine 25-100 mg have long been known to be helpful for sleep. “Advantages are that they’re anxiolytic, they’re mood stabilizing, and there is little abuse liability,” Dr. Winkelman said. “Drawbacks are that they’re probably less effective than BzRAs, they cause daytime sedation, weight gain, risks of extrapyramidal symptoms and glucose and lipid abnormalities.”
Dr. Winkelman said that he uses “a fair amount” of the anticonvulsant gabapentin as a second- or third-line hypnotic agent. “I usually start with 300 mg [at bedtime],” he added. “Drawbacks are that it’s probably less effective than BzRAs; it affects cognition; and can cause daytime sedation, dizziness, and weight gain. There are also concerns about abuse.”
Dr. Winkelman reported that he has received grant/research support from Merck, the RLS Foundation, and Luitpold Pharmaceuticals. He is also a consultant for Advance Medical, Avadel Pharmaceuticals, and UpToDate and is a member of the speakers’ bureau for Luitpold.
Give new patients 1 hour, expert advises
Give new patients 1 hour, expert advises
LAS VEGAS – Clinicians should spend 1 hour with patients who present with a chief complaint of insomnia, rather than rushing to a treatment after a 10- to 15-minute office visit, according to John W. Winkelman, MD, PhD.
“Why? Because sleep problems are usually multifactorial, involving psychiatric illness, sleep disorders, medical illness, medication, and poor sleep hygiene/stress,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “There are usually many contributing problems, and sleep quality is only as strong as the weakest link. Maybe you don’t have an hour [to meet with new patients], but you need to give adequate time, otherwise you’re not going to do justice to the problem.”
“Ask, ‘what is it that bothers you most about your insomnia? Is it the time awake at night, your total sleep time, or how you feel during the day?’ Because we’re going to use different approaches based on that chief complaint of the insomnia,” said Dr. Winkelman, chief of the Massachusetts General Sleep Disorders Clinical Research Program in the department of psychiatry at Harvard Medical School, Boston. “Cognitive-behavioral therapy for insomnia [CBT-I], for instance, is very good at reducing time awake at night. It won’t increase total sleep time, but it reduces time awake at night dramatically.”
According to the DSM-5, insomnia disorder is marked by dissatisfaction with sleep quality or quantity associated with at least one of the following: difficulty initiating sleep, difficulty maintaining sleep, and early morning awakening. “Just getting up to pee five times a night is not insomnia,” he said. “Just taking an hour and a half to fall asleep at the beginning of the night is not insomnia. There has to be distress or dysfunction related to the sleep disturbance, for a minimum of three times per week for 3 months.”
Most sleep problems are transient, but 25%-30% last more than 1 year. The differential diagnosis for chronic insomnia includes primary psychiatric disorders, medications, substances, restless legs syndrome, sleep schedule disorders, and obstructive sleep apnea.
“In general, we do not order sleep studies in people with insomnia unless we suspect sleep apnea; it’s just a waste of time,” said Dr. Winkelman, who is also a professor of psychiatry at Harvard Medical School. Indications for polysomnography include loud snoring plus one of the following: daytime sleepiness, witnessed apneas, or refractory hypertension. Other indications include abnormal behaviors or movements during sleep, unexplained excessive daytime sleepiness, and refractory sleep complaints, especially repetitive brief awakenings.
Many common cognitive and behavioral issues can produce or worsen insomnia, including inconsistent bedtimes and wake times. “That irregular schedule wreaks havoc with sleep,” he said. “It messes up the circadian rhythm. Also, homeostatic drive needs to build up: We need to be awake 16 or more hours in order to be sleepy. If people are sleeping until noon on Sundays and then trying to go to bed at their usual time, 10 or 11 at night, they’ve only been awake 10 or 11 hours. That’s why they’re going to have problems falling asleep. Also, a lot of people doze off after dinner in front of the TV. That doesn’t help.”
Spending excessive time in bed can also trigger or worsen insomnia. Dr. Winkelman recommends that people restrict their access to bed to the number of hours it is reasonable to sleep. “I see a lot of people in their 70s and 80s spending 10 hours in bed,” he said. “It doesn’t sound that crazy, but there is no way they’re going to get 10 hours of sleep. It’s physically impossible, so they spend 2 or 3 hours awake at night.” Clock-watching is another no-no. “In the middle of the night you wake up, look at the clock, and say to yourself: ‘Oh my god, I’ve been awake for 3 hours. I have 4 hours left. I need 7 hours. That means I need to go to sleep now!’ ”
An estimated 30%-40% of people with chronic insomnia have a psychiatric disorder. That means “you have to be thorough in your evaluation and act as if you’re doing a structured interview,” Dr. Winkelman said. “Ask about obsessive-compulsive disorder, generalized anxiety disorder, PTSD, et cetera, so that you understand the complete myriad of psychiatric illnesses, because psychiatric illnesses run in gangs. Comorbidity is generally the rule.”
The first-line treatment for chronic insomnia disorder is CBT-I, a multicomponent approach that includes time-in-bed restriction, stimulus control, cognitive therapy, relaxation therapy, and sleep hygiene. According to Dr. Winkelman, the cornerstone of CBT-I is time-in-bed restriction. “Many people with insomnia are spending 8.5 hours in bed to get 6.5 hours of sleep,” he said. “What you do is restrict access to bed to 6.5 hours; you initially sleep deprive them. Over the first few weeks, they hate you. After a few weeks when they start sleeping well, you start gradually increasing time in bed, but they rarely get back to the 8.5 hours in bed they were spending beforehand.”
Online CBT-I programs such as Sleepio can also be effective for improving sleep latency and wake after sleep onset, but not for total sleep time (JAMA Psychiatry. 2017;74[1]:68-75). “Not everybody responds to CBT; 50% don’t respond at a couple of months,” he said. “These are the people you need to think about medication for.”
Medications commonly used for chronic insomnia include benzodiazepine receptor agonists (BzRAs) – temazepam, eszopiclone, triazolam, zolpidem, and zaleplon are Food and Drug Administration approved – melatonin agonists, orexin antagonists, sedating antidepressants, anticonvulsants, and dopaminergic antagonists. “Each of the agents in these categories has somewhat similar mechanisms of action, and similar efficacy and contraindications,” Dr. Winkelman said. “The best way to divide the benzodiazepine receptor agonists is based on half-life. How long do you want drug on receptor in somebody with insomnia? Probably not much longer than 8 hours. Nevertheless, some psychiatrists love clonazepam, which has a 40-hour half-life. The circumstances under which clonazepam should be used for insomnia are small, such as in people with a daytime anxiety disorder.”
Consider trying triazolam, zolpidem, and zaleplon for patients who have problems falling asleep, he said, while oxazepam and eszopiclone are sensible options for people who have difficulty falling and staying asleep. Clinical response to BzRAs is common, yet only about half of people who have insomnia remit with one of these agents.
Dr. Winkelman said that patients and physicians often ask him whether BzRAs and other agents used as sleep aids are addictive. Abuse is identified when recurrent use causes clinically and functionally significant impairment, such as health problems; disability; and failure to meet major responsibilities at work, home, or school. “These are concerns with BzRAs. Misuse and abuse generally occur in younger people. Once you get to 35 years old, misuse rates get very low. In older people, rates of side effects go up.
“Tolerance, physiological and psychological dependence, and nonmedical diversion are also of concern,” he said. However, for the majority of people, BzRA hypnotics are effective and safe.
As for other agents, meta-analyses have demonstrated that melatonin 1-3 mg can help people fall asleep when it’s not being endogenously released. “That’s during the day,” he said. “That might be most relevant for jet lag and for people doing shift work.” Two orexin antagonists on the market for insomnia include suvorexant and lemborexant 10-20 mg. Advantages of these include little abuse liability and few side effects. “In one head-to-head polysomnography study in the elderly, lemborexant was superior to zolpidem 6.25 mg CR on both objective and subjective ability to fall asleep and stay asleep,” Dr. Winkelman said. (JAMA Netw Open. 2019;2[12]:e1918254).
Antidepressants are another treatment option, including mirtazapine 15-30 mg, trazodone 25-100 mg, and amitriptyline and doxepin (10-50 mg). Advantages include little abuse liability, while potential drawbacks include daytime sedation, weight gain, and anticholinergic side effects. Meanwhile, atypical antipsychotics such as quetiapine 25-100 mg have long been known to be helpful for sleep. “Advantages are that they’re anxiolytic, they’re mood stabilizing, and there is little abuse liability,” Dr. Winkelman said. “Drawbacks are that they’re probably less effective than BzRAs, they cause daytime sedation, weight gain, risks of extrapyramidal symptoms and glucose and lipid abnormalities.”
Dr. Winkelman said that he uses “a fair amount” of the anticonvulsant gabapentin as a second- or third-line hypnotic agent. “I usually start with 300 mg [at bedtime],” he added. “Drawbacks are that it’s probably less effective than BzRAs; it affects cognition; and can cause daytime sedation, dizziness, and weight gain. There are also concerns about abuse.”
Dr. Winkelman reported that he has received grant/research support from Merck, the RLS Foundation, and Luitpold Pharmaceuticals. He is also a consultant for Advance Medical, Avadel Pharmaceuticals, and UpToDate and is a member of the speakers’ bureau for Luitpold.
LAS VEGAS – Clinicians should spend 1 hour with patients who present with a chief complaint of insomnia, rather than rushing to a treatment after a 10- to 15-minute office visit, according to John W. Winkelman, MD, PhD.
“Why? Because sleep problems are usually multifactorial, involving psychiatric illness, sleep disorders, medical illness, medication, and poor sleep hygiene/stress,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “There are usually many contributing problems, and sleep quality is only as strong as the weakest link. Maybe you don’t have an hour [to meet with new patients], but you need to give adequate time, otherwise you’re not going to do justice to the problem.”
“Ask, ‘what is it that bothers you most about your insomnia? Is it the time awake at night, your total sleep time, or how you feel during the day?’ Because we’re going to use different approaches based on that chief complaint of the insomnia,” said Dr. Winkelman, chief of the Massachusetts General Sleep Disorders Clinical Research Program in the department of psychiatry at Harvard Medical School, Boston. “Cognitive-behavioral therapy for insomnia [CBT-I], for instance, is very good at reducing time awake at night. It won’t increase total sleep time, but it reduces time awake at night dramatically.”
According to the DSM-5, insomnia disorder is marked by dissatisfaction with sleep quality or quantity associated with at least one of the following: difficulty initiating sleep, difficulty maintaining sleep, and early morning awakening. “Just getting up to pee five times a night is not insomnia,” he said. “Just taking an hour and a half to fall asleep at the beginning of the night is not insomnia. There has to be distress or dysfunction related to the sleep disturbance, for a minimum of three times per week for 3 months.”
Most sleep problems are transient, but 25%-30% last more than 1 year. The differential diagnosis for chronic insomnia includes primary psychiatric disorders, medications, substances, restless legs syndrome, sleep schedule disorders, and obstructive sleep apnea.
“In general, we do not order sleep studies in people with insomnia unless we suspect sleep apnea; it’s just a waste of time,” said Dr. Winkelman, who is also a professor of psychiatry at Harvard Medical School. Indications for polysomnography include loud snoring plus one of the following: daytime sleepiness, witnessed apneas, or refractory hypertension. Other indications include abnormal behaviors or movements during sleep, unexplained excessive daytime sleepiness, and refractory sleep complaints, especially repetitive brief awakenings.
Many common cognitive and behavioral issues can produce or worsen insomnia, including inconsistent bedtimes and wake times. “That irregular schedule wreaks havoc with sleep,” he said. “It messes up the circadian rhythm. Also, homeostatic drive needs to build up: We need to be awake 16 or more hours in order to be sleepy. If people are sleeping until noon on Sundays and then trying to go to bed at their usual time, 10 or 11 at night, they’ve only been awake 10 or 11 hours. That’s why they’re going to have problems falling asleep. Also, a lot of people doze off after dinner in front of the TV. That doesn’t help.”
Spending excessive time in bed can also trigger or worsen insomnia. Dr. Winkelman recommends that people restrict their access to bed to the number of hours it is reasonable to sleep. “I see a lot of people in their 70s and 80s spending 10 hours in bed,” he said. “It doesn’t sound that crazy, but there is no way they’re going to get 10 hours of sleep. It’s physically impossible, so they spend 2 or 3 hours awake at night.” Clock-watching is another no-no. “In the middle of the night you wake up, look at the clock, and say to yourself: ‘Oh my god, I’ve been awake for 3 hours. I have 4 hours left. I need 7 hours. That means I need to go to sleep now!’ ”
An estimated 30%-40% of people with chronic insomnia have a psychiatric disorder. That means “you have to be thorough in your evaluation and act as if you’re doing a structured interview,” Dr. Winkelman said. “Ask about obsessive-compulsive disorder, generalized anxiety disorder, PTSD, et cetera, so that you understand the complete myriad of psychiatric illnesses, because psychiatric illnesses run in gangs. Comorbidity is generally the rule.”
The first-line treatment for chronic insomnia disorder is CBT-I, a multicomponent approach that includes time-in-bed restriction, stimulus control, cognitive therapy, relaxation therapy, and sleep hygiene. According to Dr. Winkelman, the cornerstone of CBT-I is time-in-bed restriction. “Many people with insomnia are spending 8.5 hours in bed to get 6.5 hours of sleep,” he said. “What you do is restrict access to bed to 6.5 hours; you initially sleep deprive them. Over the first few weeks, they hate you. After a few weeks when they start sleeping well, you start gradually increasing time in bed, but they rarely get back to the 8.5 hours in bed they were spending beforehand.”
Online CBT-I programs such as Sleepio can also be effective for improving sleep latency and wake after sleep onset, but not for total sleep time (JAMA Psychiatry. 2017;74[1]:68-75). “Not everybody responds to CBT; 50% don’t respond at a couple of months,” he said. “These are the people you need to think about medication for.”
Medications commonly used for chronic insomnia include benzodiazepine receptor agonists (BzRAs) – temazepam, eszopiclone, triazolam, zolpidem, and zaleplon are Food and Drug Administration approved – melatonin agonists, orexin antagonists, sedating antidepressants, anticonvulsants, and dopaminergic antagonists. “Each of the agents in these categories has somewhat similar mechanisms of action, and similar efficacy and contraindications,” Dr. Winkelman said. “The best way to divide the benzodiazepine receptor agonists is based on half-life. How long do you want drug on receptor in somebody with insomnia? Probably not much longer than 8 hours. Nevertheless, some psychiatrists love clonazepam, which has a 40-hour half-life. The circumstances under which clonazepam should be used for insomnia are small, such as in people with a daytime anxiety disorder.”
Consider trying triazolam, zolpidem, and zaleplon for patients who have problems falling asleep, he said, while oxazepam and eszopiclone are sensible options for people who have difficulty falling and staying asleep. Clinical response to BzRAs is common, yet only about half of people who have insomnia remit with one of these agents.
Dr. Winkelman said that patients and physicians often ask him whether BzRAs and other agents used as sleep aids are addictive. Abuse is identified when recurrent use causes clinically and functionally significant impairment, such as health problems; disability; and failure to meet major responsibilities at work, home, or school. “These are concerns with BzRAs. Misuse and abuse generally occur in younger people. Once you get to 35 years old, misuse rates get very low. In older people, rates of side effects go up.
“Tolerance, physiological and psychological dependence, and nonmedical diversion are also of concern,” he said. However, for the majority of people, BzRA hypnotics are effective and safe.
As for other agents, meta-analyses have demonstrated that melatonin 1-3 mg can help people fall asleep when it’s not being endogenously released. “That’s during the day,” he said. “That might be most relevant for jet lag and for people doing shift work.” Two orexin antagonists on the market for insomnia include suvorexant and lemborexant 10-20 mg. Advantages of these include little abuse liability and few side effects. “In one head-to-head polysomnography study in the elderly, lemborexant was superior to zolpidem 6.25 mg CR on both objective and subjective ability to fall asleep and stay asleep,” Dr. Winkelman said. (JAMA Netw Open. 2019;2[12]:e1918254).
Antidepressants are another treatment option, including mirtazapine 15-30 mg, trazodone 25-100 mg, and amitriptyline and doxepin (10-50 mg). Advantages include little abuse liability, while potential drawbacks include daytime sedation, weight gain, and anticholinergic side effects. Meanwhile, atypical antipsychotics such as quetiapine 25-100 mg have long been known to be helpful for sleep. “Advantages are that they’re anxiolytic, they’re mood stabilizing, and there is little abuse liability,” Dr. Winkelman said. “Drawbacks are that they’re probably less effective than BzRAs, they cause daytime sedation, weight gain, risks of extrapyramidal symptoms and glucose and lipid abnormalities.”
Dr. Winkelman said that he uses “a fair amount” of the anticonvulsant gabapentin as a second- or third-line hypnotic agent. “I usually start with 300 mg [at bedtime],” he added. “Drawbacks are that it’s probably less effective than BzRAs; it affects cognition; and can cause daytime sedation, dizziness, and weight gain. There are also concerns about abuse.”
Dr. Winkelman reported that he has received grant/research support from Merck, the RLS Foundation, and Luitpold Pharmaceuticals. He is also a consultant for Advance Medical, Avadel Pharmaceuticals, and UpToDate and is a member of the speakers’ bureau for Luitpold.
EXPERT ANALYSIS FROM NPA 2020
Supreme Court roundup: Latest health care decisions
The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.
The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.
Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.
The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.
Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.
In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.
“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”
In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.
“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”
ACA cases still in limbo
Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.
The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.
Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.
In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.
If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.
Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.
The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.
The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.
The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.
A Supreme Court decision in the case could come as soon as Feb. 26.
Court to hear women’s health cases
Two closely watched reproductive health cases will go before the court this spring.
On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.
June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.
The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.
And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.
A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.
Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.
The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.
The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.
Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.
The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.
Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.
In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.
“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”
In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.
“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”
ACA cases still in limbo
Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.
The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.
Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.
In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.
If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.
Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.
The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.
The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.
The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.
A Supreme Court decision in the case could come as soon as Feb. 26.
Court to hear women’s health cases
Two closely watched reproductive health cases will go before the court this spring.
On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.
June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.
The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.
And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.
A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.
Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.
The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.
The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.
Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.
The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.
Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.
In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.
“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”
In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.
“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”
ACA cases still in limbo
Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.
The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.
Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.
In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.
If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.
Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.
The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.
The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.
The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.
A Supreme Court decision in the case could come as soon as Feb. 26.
Court to hear women’s health cases
Two closely watched reproductive health cases will go before the court this spring.
On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.
June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.
The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.
And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.
A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.
Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.
How to beat bullying in the workplace
Cyberbullying can prove particularly insidious
Bullying happens to our patients and sometimes to the doctors in the medical community. As psychiatrists, we need to share information on how to spot it and deal with it in the workplace.
We can view bullying as the endpoint in a continuum with authority at one end and harassment at the other extreme. Discipline maintains order but those in charge can be misguided or mean spirited.
Bullying is bad and prevalent, but is it inevitable in the workplace? There are three categories: those who get bullied, those who bully, and those who witness bullying. Any one, two, or even all three can apply in a work environment. Some escape the problem, and for them, bullying remains theoretical, a phenomenon to understand.
How do we define bullying? You know it when you see it; bullying interferes with functioning. It includes harsh language, threats, snubbing, screaming, and undermining.
Case is illustrative
Helen, a medical consultant on a surgical unit, was reading a chart when another internist arrived for the same purpose. He introduced himself as a new full-time assistant to the head of medical consultations. Helen greeted him and said: “Since I started with this case, I will continue. There was probably an error in the referral process.” Bill looked concerned. “But he has uncontrolled diabetes.” Taken aback, Helen said: “I think I can handle it. I’ve been on the hospital staff for 25 years.”
Then the bullying began. On occasion, Bill and a resident consulted on patients Helen was treating already, as though her input were nonexistent. When Helen inquired about this, rather than attribute it to an error in communication within a large hospital, Bill diminished the value of her input. She asked, “How many medical consultants does a patient need?” She decided to confront Bill and tell him that he had no reason to treat her with disrespect. After that, Bill’s disparaging remarks intensified and he threatened her saying, “I’m not someone you want to go up against.” Bill sent her an email, “You are demeaning and harsh to the staff; if you want to retain your hospital credentials you must change your behavior.” In her response, Helen agreed to meet with Bill and she emailed, “It is not in my nature to mistreat anyone, staff or patient.” The meeting never happened.
Helen sought me out for psychiatric consultation and psychotherapy because she felt demoralized. Confused by Bill’s assault on her reputation, she needed a strategy and confirmation of her worth. We conceived a plan. Helen decided to get busy and get better. She redoubled her efforts to be cordial, and she remained effective with her patients. I suggested that she confide in a trusted senior attending at the hospital, which she did. She aired her insights to him. Excellence mattered and the threats disappeared. Bill had no power over Helen after all. She was a voluntary attending. She never succumbed to despair; rather she converted her response to the threats into useful energy.
When does authority become harassment?
A pecking order exists in every organization because, from the CEO to the janitor, it is necessary to maintain productivity. But when does this hierarchy become abusive? Discipline gets learned early. Those who are familiar with the comic strip “Calvin and Hobbes” by Bill Watterson may remember the 6-year-old boy asserting his intention to stay home from school – only to be forced to the bus stop by his mother. Call that authority, discipline, or even bullying, but it represents a child’s first encounter with obedience despite protest. When authority interferes rather than enhances effectiveness, question the methods used to attain order.
The vulnerable
If you do your job and you do it well, there should be no bullying. It is hard to know why a target gets chosen for harassment. However, some questions may need answering by the target. Does he or she avoid conflict even when there is bad behavior? Does past trauma immobilize him into passivity? Such issues necessitate self examination. Psychotherapy helps to uncover and clear up these issues.
Is bullying a fact of life?
In “Lord of the Flies,” William Golding portrays a fictional group of unsupervised boys abandoned on an island. An initial hierarchy descends into threats and eventual violence. Consider the animal world. In the wild, a wolf pack isolates a caribou from the herd to kill and devour. On a farm, llamas raised for yarn establish which llama is in charge. Those cases illustrate the hierarchy that exists because there is the need for food or reproductive prowess.
In the workplace, isolation of the target is common when authority extends to bullying. According to Robert Sapolsky, PhD, a neuroscientist and author, there are biological underpinnings for group conformity. This implies that colleagues who stand apart feel distress and get relief when they join the ganging up on a target. Those who watch harassment may hide from confronting it or even from pointing it out to protect themselves.
How do bullies think?
Challenge the bully at your own peril, because expecting a bully to change is futile. Recall Helen’s confrontation with Bill. It provoked him. His power to harass her came from his perceived position. Bullies regard the pleasant person as weak. Bullies can fall into two categories: Sadists who get pleasure from seeing others suffer, and opportunists. The latter focus only on their goals and disregard concerns expressed by others. Outside of the workplace, they may be reasonable. If workplace morale deteriorates along with productivity, the bully gets ousted. Otherwise, companies usually protect high performers at the expense of targets.
Is bullying different in medicine?
It can happen in a training program. The ingredients for bullying exist, including imbalance of power. Often, there are no witnesses, and there can be lack of accountability because of changing authorities. Just as technology can help make harassment possible, it also enables the target to spot and document inappropriate communications by saving emails and texts. Whenever a need for advancement exists along with changing authority, bullying gets tolerated. Who wants to be derailed by reporting? Those in training have the goal of completing a program. If they report bullying, they fear antagonism and retribution, a personal expense that can deter advancement.
Remedies
Let truth and fairness be your guide. That is easy to say and hard to do, but there are helpful personal and legal resources.
Personal capability
Get busy; get better. That became Helen’s method of choice. She focused on her role and productivity, not on her hurt. Helen shunned victimhood. With the help of psychotherapy and by confiding in a mentor, she prevailed. What works is recalling challenges that were mastered and the qualities that made for success. Acquire skills, build a good reputation, be assertive, not defensive.
The group is powerful, and that means it is important to build alliances above and below in the organizational hierarchy; cultivate friendship with trustworthy people. Occasionally, there is unwarranted ganging up on a manager, bullying from below. It is more likely to happen to a newly appointed supervisor. A way to avert that is to communicate with staff throughout the institution and remain accessible.
Legal options
What are legal options to confront bullying? Of note, workplace bullying is not necessarily illegal. According to one employment attorney, “There is no law that prohibits uncivil behavior on the job.” However, under Title VII of the federal law enacted in 1964, there are protected characteristics such as race, color, national origin, sex, age, and disability. The Equal Employment Opportunity Commission enforces Title VII. In cases of assault or stalking, harassment is illegal and criminal.
Some employees report to Human Resources or seek out their company’s employee assistance program. As useful as those options may be, they are part of the company and potentially partial to the administration. There can be incentives to protect those with power against a complainant. For assistance, it is preferable to enlist an outside attorney and a therapist in the community.
Advocacy exists. The Workplace Bullying Institute maintains a website, holds workshops, promotes literature, and offers information. The National Employment Lawyers Association can provide referrals or recommendations that come from other legal sources. Cases rarely reach court because of the expense of a trial; rather, the parties reach a financial settlement. When there is cause, an employment attorney can best pursue justice for the worker.
Conclusion
Get busy; get better is the solution to bullying. Avoid victimhood. That means prepare: Update the resume, seek opportunities, and identify allies. Bullies get beaten; as Abraham Lincoln said, “You can fool some of the people some of the time but you can’t fool all of the people all of the time.”
According to the Workplace Bullying Institute, 7 out of 10 bullied workers either resign or get fired. You should leave only when the leaving is better than the staying. Bullying brings out the worst in the workplace. Those who bully isolate the target. Coworkers often shun the target, fearing for their own position; they may even participate in the harassment. Psychiatrists need to remain sensitive to harassment in their own environment and for their patients. We have tools to address bullying in the workplace and a moral responsibility to combat it.
References
Workplace Bullying Institute (WBI)
National Employment Lawyers Association (NELA)
“Ozymandias” by Percy Bysshe Shelley
BY BEN HINDELL, PSY.D.
Cyberbullying is willful, repeated harm inflicted with the use of computers, cell phones, and other electronic devices. In some cases, a single message may be viewed by multiple people because the text and pictures are posted elsewhere.
Technology makes is possible to harass at any hour. The concept of willful harm is essential. Without interaction between sender and recipient, nuances are lost. Face to face might make a communication benign instead of malevolent or threatening. This has implications for the workplace, where colleagues increasingly communicate by email rather than discuss matters in person or by telephone.
Steps for survivors of cyberbullying
- Do not respond immediately to an inflammatory message, post, or email. Gather your thoughts and avoid responding in anger.
- Keep calm and rational, not emotional.
- Try to respond in person and work to avoid a conflict.
- Remember, your interpretation may differ from what was intended.
- Communicate openly and honestly and not defensively.
- Calmly indicate you were offended and you want the comments to stop.
- Move up the chain of command, if comments don’t cease.
- Save all messages and posts as evidence.
- Report the cyberbullying to your employer. Human resources may get involved.
- Detach from the cyberbully, if it continues. Block social media, cell phone messaging, and emails.
- Find support from friends, family, and a psychotherapist, if needed. As a last resort, it may become necessary to enlist an attorney.
- Take the high road; remain calm and professional at work. The bully may be seeking a reaction from the behavior. Prevent it.
All of the elements of workplace bullying apply to cyberbullying, but the latter can be more insidious. Psychiatrists and psychologists are able to support patients who deal with cyberbullying and help them cope successfully.
Dr. Cohen is in private practice and is a clinical assistant professor of psychiatry at Weill Cornell Medical Center of New York-Presbyterian Hospital, and psychiatric consultant at the Hospital for Special Surgery, also in New York. She made changes to the patient’s story to protect confidentiality.
Dr. Hindell is a psychologist with the Mental Health Service of Colorado College, Colorado Springs. He also practices psychotherapy in Denver. Dr. Hindell is the son of Dr. Cohen.
Cyberbullying can prove particularly insidious
Cyberbullying can prove particularly insidious
Bullying happens to our patients and sometimes to the doctors in the medical community. As psychiatrists, we need to share information on how to spot it and deal with it in the workplace.
We can view bullying as the endpoint in a continuum with authority at one end and harassment at the other extreme. Discipline maintains order but those in charge can be misguided or mean spirited.
Bullying is bad and prevalent, but is it inevitable in the workplace? There are three categories: those who get bullied, those who bully, and those who witness bullying. Any one, two, or even all three can apply in a work environment. Some escape the problem, and for them, bullying remains theoretical, a phenomenon to understand.
How do we define bullying? You know it when you see it; bullying interferes with functioning. It includes harsh language, threats, snubbing, screaming, and undermining.
Case is illustrative
Helen, a medical consultant on a surgical unit, was reading a chart when another internist arrived for the same purpose. He introduced himself as a new full-time assistant to the head of medical consultations. Helen greeted him and said: “Since I started with this case, I will continue. There was probably an error in the referral process.” Bill looked concerned. “But he has uncontrolled diabetes.” Taken aback, Helen said: “I think I can handle it. I’ve been on the hospital staff for 25 years.”
Then the bullying began. On occasion, Bill and a resident consulted on patients Helen was treating already, as though her input were nonexistent. When Helen inquired about this, rather than attribute it to an error in communication within a large hospital, Bill diminished the value of her input. She asked, “How many medical consultants does a patient need?” She decided to confront Bill and tell him that he had no reason to treat her with disrespect. After that, Bill’s disparaging remarks intensified and he threatened her saying, “I’m not someone you want to go up against.” Bill sent her an email, “You are demeaning and harsh to the staff; if you want to retain your hospital credentials you must change your behavior.” In her response, Helen agreed to meet with Bill and she emailed, “It is not in my nature to mistreat anyone, staff or patient.” The meeting never happened.
Helen sought me out for psychiatric consultation and psychotherapy because she felt demoralized. Confused by Bill’s assault on her reputation, she needed a strategy and confirmation of her worth. We conceived a plan. Helen decided to get busy and get better. She redoubled her efforts to be cordial, and she remained effective with her patients. I suggested that she confide in a trusted senior attending at the hospital, which she did. She aired her insights to him. Excellence mattered and the threats disappeared. Bill had no power over Helen after all. She was a voluntary attending. She never succumbed to despair; rather she converted her response to the threats into useful energy.
When does authority become harassment?
A pecking order exists in every organization because, from the CEO to the janitor, it is necessary to maintain productivity. But when does this hierarchy become abusive? Discipline gets learned early. Those who are familiar with the comic strip “Calvin and Hobbes” by Bill Watterson may remember the 6-year-old boy asserting his intention to stay home from school – only to be forced to the bus stop by his mother. Call that authority, discipline, or even bullying, but it represents a child’s first encounter with obedience despite protest. When authority interferes rather than enhances effectiveness, question the methods used to attain order.
The vulnerable
If you do your job and you do it well, there should be no bullying. It is hard to know why a target gets chosen for harassment. However, some questions may need answering by the target. Does he or she avoid conflict even when there is bad behavior? Does past trauma immobilize him into passivity? Such issues necessitate self examination. Psychotherapy helps to uncover and clear up these issues.
Is bullying a fact of life?
In “Lord of the Flies,” William Golding portrays a fictional group of unsupervised boys abandoned on an island. An initial hierarchy descends into threats and eventual violence. Consider the animal world. In the wild, a wolf pack isolates a caribou from the herd to kill and devour. On a farm, llamas raised for yarn establish which llama is in charge. Those cases illustrate the hierarchy that exists because there is the need for food or reproductive prowess.
In the workplace, isolation of the target is common when authority extends to bullying. According to Robert Sapolsky, PhD, a neuroscientist and author, there are biological underpinnings for group conformity. This implies that colleagues who stand apart feel distress and get relief when they join the ganging up on a target. Those who watch harassment may hide from confronting it or even from pointing it out to protect themselves.
How do bullies think?
Challenge the bully at your own peril, because expecting a bully to change is futile. Recall Helen’s confrontation with Bill. It provoked him. His power to harass her came from his perceived position. Bullies regard the pleasant person as weak. Bullies can fall into two categories: Sadists who get pleasure from seeing others suffer, and opportunists. The latter focus only on their goals and disregard concerns expressed by others. Outside of the workplace, they may be reasonable. If workplace morale deteriorates along with productivity, the bully gets ousted. Otherwise, companies usually protect high performers at the expense of targets.
Is bullying different in medicine?
It can happen in a training program. The ingredients for bullying exist, including imbalance of power. Often, there are no witnesses, and there can be lack of accountability because of changing authorities. Just as technology can help make harassment possible, it also enables the target to spot and document inappropriate communications by saving emails and texts. Whenever a need for advancement exists along with changing authority, bullying gets tolerated. Who wants to be derailed by reporting? Those in training have the goal of completing a program. If they report bullying, they fear antagonism and retribution, a personal expense that can deter advancement.
Remedies
Let truth and fairness be your guide. That is easy to say and hard to do, but there are helpful personal and legal resources.
Personal capability
Get busy; get better. That became Helen’s method of choice. She focused on her role and productivity, not on her hurt. Helen shunned victimhood. With the help of psychotherapy and by confiding in a mentor, she prevailed. What works is recalling challenges that were mastered and the qualities that made for success. Acquire skills, build a good reputation, be assertive, not defensive.
The group is powerful, and that means it is important to build alliances above and below in the organizational hierarchy; cultivate friendship with trustworthy people. Occasionally, there is unwarranted ganging up on a manager, bullying from below. It is more likely to happen to a newly appointed supervisor. A way to avert that is to communicate with staff throughout the institution and remain accessible.
Legal options
What are legal options to confront bullying? Of note, workplace bullying is not necessarily illegal. According to one employment attorney, “There is no law that prohibits uncivil behavior on the job.” However, under Title VII of the federal law enacted in 1964, there are protected characteristics such as race, color, national origin, sex, age, and disability. The Equal Employment Opportunity Commission enforces Title VII. In cases of assault or stalking, harassment is illegal and criminal.
Some employees report to Human Resources or seek out their company’s employee assistance program. As useful as those options may be, they are part of the company and potentially partial to the administration. There can be incentives to protect those with power against a complainant. For assistance, it is preferable to enlist an outside attorney and a therapist in the community.
Advocacy exists. The Workplace Bullying Institute maintains a website, holds workshops, promotes literature, and offers information. The National Employment Lawyers Association can provide referrals or recommendations that come from other legal sources. Cases rarely reach court because of the expense of a trial; rather, the parties reach a financial settlement. When there is cause, an employment attorney can best pursue justice for the worker.
Conclusion
Get busy; get better is the solution to bullying. Avoid victimhood. That means prepare: Update the resume, seek opportunities, and identify allies. Bullies get beaten; as Abraham Lincoln said, “You can fool some of the people some of the time but you can’t fool all of the people all of the time.”
According to the Workplace Bullying Institute, 7 out of 10 bullied workers either resign or get fired. You should leave only when the leaving is better than the staying. Bullying brings out the worst in the workplace. Those who bully isolate the target. Coworkers often shun the target, fearing for their own position; they may even participate in the harassment. Psychiatrists need to remain sensitive to harassment in their own environment and for their patients. We have tools to address bullying in the workplace and a moral responsibility to combat it.
References
Workplace Bullying Institute (WBI)
National Employment Lawyers Association (NELA)
“Ozymandias” by Percy Bysshe Shelley
BY BEN HINDELL, PSY.D.
Cyberbullying is willful, repeated harm inflicted with the use of computers, cell phones, and other electronic devices. In some cases, a single message may be viewed by multiple people because the text and pictures are posted elsewhere.
Technology makes is possible to harass at any hour. The concept of willful harm is essential. Without interaction between sender and recipient, nuances are lost. Face to face might make a communication benign instead of malevolent or threatening. This has implications for the workplace, where colleagues increasingly communicate by email rather than discuss matters in person or by telephone.
Steps for survivors of cyberbullying
- Do not respond immediately to an inflammatory message, post, or email. Gather your thoughts and avoid responding in anger.
- Keep calm and rational, not emotional.
- Try to respond in person and work to avoid a conflict.
- Remember, your interpretation may differ from what was intended.
- Communicate openly and honestly and not defensively.
- Calmly indicate you were offended and you want the comments to stop.
- Move up the chain of command, if comments don’t cease.
- Save all messages and posts as evidence.
- Report the cyberbullying to your employer. Human resources may get involved.
- Detach from the cyberbully, if it continues. Block social media, cell phone messaging, and emails.
- Find support from friends, family, and a psychotherapist, if needed. As a last resort, it may become necessary to enlist an attorney.
- Take the high road; remain calm and professional at work. The bully may be seeking a reaction from the behavior. Prevent it.
All of the elements of workplace bullying apply to cyberbullying, but the latter can be more insidious. Psychiatrists and psychologists are able to support patients who deal with cyberbullying and help them cope successfully.
Dr. Cohen is in private practice and is a clinical assistant professor of psychiatry at Weill Cornell Medical Center of New York-Presbyterian Hospital, and psychiatric consultant at the Hospital for Special Surgery, also in New York. She made changes to the patient’s story to protect confidentiality.
Dr. Hindell is a psychologist with the Mental Health Service of Colorado College, Colorado Springs. He also practices psychotherapy in Denver. Dr. Hindell is the son of Dr. Cohen.
Bullying happens to our patients and sometimes to the doctors in the medical community. As psychiatrists, we need to share information on how to spot it and deal with it in the workplace.
We can view bullying as the endpoint in a continuum with authority at one end and harassment at the other extreme. Discipline maintains order but those in charge can be misguided or mean spirited.
Bullying is bad and prevalent, but is it inevitable in the workplace? There are three categories: those who get bullied, those who bully, and those who witness bullying. Any one, two, or even all three can apply in a work environment. Some escape the problem, and for them, bullying remains theoretical, a phenomenon to understand.
How do we define bullying? You know it when you see it; bullying interferes with functioning. It includes harsh language, threats, snubbing, screaming, and undermining.
Case is illustrative
Helen, a medical consultant on a surgical unit, was reading a chart when another internist arrived for the same purpose. He introduced himself as a new full-time assistant to the head of medical consultations. Helen greeted him and said: “Since I started with this case, I will continue. There was probably an error in the referral process.” Bill looked concerned. “But he has uncontrolled diabetes.” Taken aback, Helen said: “I think I can handle it. I’ve been on the hospital staff for 25 years.”
Then the bullying began. On occasion, Bill and a resident consulted on patients Helen was treating already, as though her input were nonexistent. When Helen inquired about this, rather than attribute it to an error in communication within a large hospital, Bill diminished the value of her input. She asked, “How many medical consultants does a patient need?” She decided to confront Bill and tell him that he had no reason to treat her with disrespect. After that, Bill’s disparaging remarks intensified and he threatened her saying, “I’m not someone you want to go up against.” Bill sent her an email, “You are demeaning and harsh to the staff; if you want to retain your hospital credentials you must change your behavior.” In her response, Helen agreed to meet with Bill and she emailed, “It is not in my nature to mistreat anyone, staff or patient.” The meeting never happened.
Helen sought me out for psychiatric consultation and psychotherapy because she felt demoralized. Confused by Bill’s assault on her reputation, she needed a strategy and confirmation of her worth. We conceived a plan. Helen decided to get busy and get better. She redoubled her efforts to be cordial, and she remained effective with her patients. I suggested that she confide in a trusted senior attending at the hospital, which she did. She aired her insights to him. Excellence mattered and the threats disappeared. Bill had no power over Helen after all. She was a voluntary attending. She never succumbed to despair; rather she converted her response to the threats into useful energy.
When does authority become harassment?
A pecking order exists in every organization because, from the CEO to the janitor, it is necessary to maintain productivity. But when does this hierarchy become abusive? Discipline gets learned early. Those who are familiar with the comic strip “Calvin and Hobbes” by Bill Watterson may remember the 6-year-old boy asserting his intention to stay home from school – only to be forced to the bus stop by his mother. Call that authority, discipline, or even bullying, but it represents a child’s first encounter with obedience despite protest. When authority interferes rather than enhances effectiveness, question the methods used to attain order.
The vulnerable
If you do your job and you do it well, there should be no bullying. It is hard to know why a target gets chosen for harassment. However, some questions may need answering by the target. Does he or she avoid conflict even when there is bad behavior? Does past trauma immobilize him into passivity? Such issues necessitate self examination. Psychotherapy helps to uncover and clear up these issues.
Is bullying a fact of life?
In “Lord of the Flies,” William Golding portrays a fictional group of unsupervised boys abandoned on an island. An initial hierarchy descends into threats and eventual violence. Consider the animal world. In the wild, a wolf pack isolates a caribou from the herd to kill and devour. On a farm, llamas raised for yarn establish which llama is in charge. Those cases illustrate the hierarchy that exists because there is the need for food or reproductive prowess.
In the workplace, isolation of the target is common when authority extends to bullying. According to Robert Sapolsky, PhD, a neuroscientist and author, there are biological underpinnings for group conformity. This implies that colleagues who stand apart feel distress and get relief when they join the ganging up on a target. Those who watch harassment may hide from confronting it or even from pointing it out to protect themselves.
How do bullies think?
Challenge the bully at your own peril, because expecting a bully to change is futile. Recall Helen’s confrontation with Bill. It provoked him. His power to harass her came from his perceived position. Bullies regard the pleasant person as weak. Bullies can fall into two categories: Sadists who get pleasure from seeing others suffer, and opportunists. The latter focus only on their goals and disregard concerns expressed by others. Outside of the workplace, they may be reasonable. If workplace morale deteriorates along with productivity, the bully gets ousted. Otherwise, companies usually protect high performers at the expense of targets.
Is bullying different in medicine?
It can happen in a training program. The ingredients for bullying exist, including imbalance of power. Often, there are no witnesses, and there can be lack of accountability because of changing authorities. Just as technology can help make harassment possible, it also enables the target to spot and document inappropriate communications by saving emails and texts. Whenever a need for advancement exists along with changing authority, bullying gets tolerated. Who wants to be derailed by reporting? Those in training have the goal of completing a program. If they report bullying, they fear antagonism and retribution, a personal expense that can deter advancement.
Remedies
Let truth and fairness be your guide. That is easy to say and hard to do, but there are helpful personal and legal resources.
Personal capability
Get busy; get better. That became Helen’s method of choice. She focused on her role and productivity, not on her hurt. Helen shunned victimhood. With the help of psychotherapy and by confiding in a mentor, she prevailed. What works is recalling challenges that were mastered and the qualities that made for success. Acquire skills, build a good reputation, be assertive, not defensive.
The group is powerful, and that means it is important to build alliances above and below in the organizational hierarchy; cultivate friendship with trustworthy people. Occasionally, there is unwarranted ganging up on a manager, bullying from below. It is more likely to happen to a newly appointed supervisor. A way to avert that is to communicate with staff throughout the institution and remain accessible.
Legal options
What are legal options to confront bullying? Of note, workplace bullying is not necessarily illegal. According to one employment attorney, “There is no law that prohibits uncivil behavior on the job.” However, under Title VII of the federal law enacted in 1964, there are protected characteristics such as race, color, national origin, sex, age, and disability. The Equal Employment Opportunity Commission enforces Title VII. In cases of assault or stalking, harassment is illegal and criminal.
Some employees report to Human Resources or seek out their company’s employee assistance program. As useful as those options may be, they are part of the company and potentially partial to the administration. There can be incentives to protect those with power against a complainant. For assistance, it is preferable to enlist an outside attorney and a therapist in the community.
Advocacy exists. The Workplace Bullying Institute maintains a website, holds workshops, promotes literature, and offers information. The National Employment Lawyers Association can provide referrals or recommendations that come from other legal sources. Cases rarely reach court because of the expense of a trial; rather, the parties reach a financial settlement. When there is cause, an employment attorney can best pursue justice for the worker.
Conclusion
Get busy; get better is the solution to bullying. Avoid victimhood. That means prepare: Update the resume, seek opportunities, and identify allies. Bullies get beaten; as Abraham Lincoln said, “You can fool some of the people some of the time but you can’t fool all of the people all of the time.”
According to the Workplace Bullying Institute, 7 out of 10 bullied workers either resign or get fired. You should leave only when the leaving is better than the staying. Bullying brings out the worst in the workplace. Those who bully isolate the target. Coworkers often shun the target, fearing for their own position; they may even participate in the harassment. Psychiatrists need to remain sensitive to harassment in their own environment and for their patients. We have tools to address bullying in the workplace and a moral responsibility to combat it.
References
Workplace Bullying Institute (WBI)
National Employment Lawyers Association (NELA)
“Ozymandias” by Percy Bysshe Shelley
BY BEN HINDELL, PSY.D.
Cyberbullying is willful, repeated harm inflicted with the use of computers, cell phones, and other electronic devices. In some cases, a single message may be viewed by multiple people because the text and pictures are posted elsewhere.
Technology makes is possible to harass at any hour. The concept of willful harm is essential. Without interaction between sender and recipient, nuances are lost. Face to face might make a communication benign instead of malevolent or threatening. This has implications for the workplace, where colleagues increasingly communicate by email rather than discuss matters in person or by telephone.
Steps for survivors of cyberbullying
- Do not respond immediately to an inflammatory message, post, or email. Gather your thoughts and avoid responding in anger.
- Keep calm and rational, not emotional.
- Try to respond in person and work to avoid a conflict.
- Remember, your interpretation may differ from what was intended.
- Communicate openly and honestly and not defensively.
- Calmly indicate you were offended and you want the comments to stop.
- Move up the chain of command, if comments don’t cease.
- Save all messages and posts as evidence.
- Report the cyberbullying to your employer. Human resources may get involved.
- Detach from the cyberbully, if it continues. Block social media, cell phone messaging, and emails.
- Find support from friends, family, and a psychotherapist, if needed. As a last resort, it may become necessary to enlist an attorney.
- Take the high road; remain calm and professional at work. The bully may be seeking a reaction from the behavior. Prevent it.
All of the elements of workplace bullying apply to cyberbullying, but the latter can be more insidious. Psychiatrists and psychologists are able to support patients who deal with cyberbullying and help them cope successfully.
Dr. Cohen is in private practice and is a clinical assistant professor of psychiatry at Weill Cornell Medical Center of New York-Presbyterian Hospital, and psychiatric consultant at the Hospital for Special Surgery, also in New York. She made changes to the patient’s story to protect confidentiality.
Dr. Hindell is a psychologist with the Mental Health Service of Colorado College, Colorado Springs. He also practices psychotherapy in Denver. Dr. Hindell is the son of Dr. Cohen.
USPSTF again deems evidence insufficient to recommend cognitive impairment screening in older adults
The U.S. Preventive Services Task Force has deemed the current evidence “insufficient” to make a recommendation in regard to screening for cognitive impairment in adults aged 65 years or older.
“More research is needed on the effect of screening and early detection of cognitive impairment on important patient, caregiver, and societal outcomes, including decision making, advance planning, and caregiver outcomes,” wrote lead author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the task force. The statement was published in JAMA.
To update a 2014 recommendation from the USPSTF, which also found insufficient evidence to properly assess cognitive screening’s benefits and harms, the task force commissioned a systematic review of studies applicable to community-dwelling older adults who are not exhibiting signs or symptoms of cognitive impairment. For their statement, “cognitive impairment” is defined as mild cognitive impairment and mild to moderate dementia.
Ultimately, they determined several factors that limited the overall evidence, including the short duration of most trials and the heterogenous nature of interventions and inconsistencies in outcomes reported. Any evidence that suggested improvements was mostly applicable to patients with moderate dementia, meaning “its applicability to a screen-detected population is uncertain.”
Updating 2014 recommendations
Their statement was based on an evidence report, also published in JAMA, in which a team of researchers reviewed 287 studies that included more than 285,000 older adults; 92 of the studies were newly identified, while the other 195 were carried forward from the 2014 recommendation’s review. The researchers sought the answers to five key questions, carrying over the framework from the previous review.
“Despite the accumulation of new data, the conclusions for these key questions are essentially unchanged from the prior review,” wrote lead author Carrie D. Patnode, PhD, of the Kaiser Permanente Center for Health Research in Portland, Ore., and coauthors.
Of the questions – which concerned the accuracy of screening instruments; the harms of screening; the harms of interventions; and if screening or interventions improved decision making or outcomes for the patient, family/caregiver, or society – moderate evidence was found to support the accuracy of the instruments, treatment with acetylcholinesterase inhibitors and memantine for patients with moderate dementia, and psychoeducation interventions for caregivers of patients with moderate dementia. At the same time, there was moderate evidence of adverse effects from acetylcholinesterase inhibitors and memantine in patients with moderate dementia.
“I think, eventually, there will be sufficient evidence to justify screening, once we have what I call a tiered approach,” Marwan Sabbagh, MD, of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, said in an interview. “The very near future will include blood tests for Alzheimer’s, or PET scans, or genetics, or something else. Right now, the cognitive screens lack the specificity and sensitivity, and the secondary screening infrastructure that would improve the accuracy doesn’t exist yet.
“I think this is a ‘not now,’ ” he added, “but I wouldn’t say ‘not ever.’ ”
Dr. Patnode and coauthors noted specific limitations in the evidence, including a lack of studies on how screening for and treating cognitive impairment affects decision making. In addition, details like quality of life and institutionalization were inconsistently reported, and “consistent and standardized reporting of results according to meaningful thresholds of clinical significance” would have been valuable across all measures.
Clinical implications
The implications of this report’s conclusions are substantial, especially as the rising prevalence of mild cognitive impairment and dementia becomes a worldwide concern, wrote Ronald C. Petersen, PhD, MD, of the Mayo Clinic in Rochester, Minn., and Kristine Yaffe, MD, of the University of California, San Francisco, in an accompanying editorial.
Though the data does not explicitly support screening, Dr. Petersen and Dr. Yaffe noted that it still may have benefits. An estimated 10% of cognitive impairment is caused by at least somewhat reversible causes, and screening could also be used to improve care in medical problems that are worsened by cognitive impairment. To find the true value of these efforts, they wrote, researchers need to design and execute additional clinical trials that “answer many of the important questions surrounding screening and treatment of cognitive impairment.”
“The absence of evidence for benefit may lead to inaction,” they added, noting that clinicians screening should still consider the value of screening on a case-by-case basis in order to keep up with the impact of new disease-modifying therapies for certain neurodegenerative diseases.
All members of the USPSTF received travel reimbursement and an honorarium for participating in meetings. One member reported receiving grants and personal fees from Healthwise. The study was funded by the Department of Health & Human Services. One of the authors reported receiving grants from the National Institutes of Health and the Food and Drug Administration. Dr. Petersen and Dr. Yaffe reported consulting for, and receiving funding from, various pharmaceutical companies, foundations, and government organizations.
SOURCES: Owens DK et al. JAMA. 2020 Feb 25. doi: 10.1001/jama.2020.0435; Patnode CD et al. JAMA. 2020 Feb 25. doi: 10.1001/jama.2019.22258.
The U.S. Preventive Services Task Force has deemed the current evidence “insufficient” to make a recommendation in regard to screening for cognitive impairment in adults aged 65 years or older.
“More research is needed on the effect of screening and early detection of cognitive impairment on important patient, caregiver, and societal outcomes, including decision making, advance planning, and caregiver outcomes,” wrote lead author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the task force. The statement was published in JAMA.
To update a 2014 recommendation from the USPSTF, which also found insufficient evidence to properly assess cognitive screening’s benefits and harms, the task force commissioned a systematic review of studies applicable to community-dwelling older adults who are not exhibiting signs or symptoms of cognitive impairment. For their statement, “cognitive impairment” is defined as mild cognitive impairment and mild to moderate dementia.
Ultimately, they determined several factors that limited the overall evidence, including the short duration of most trials and the heterogenous nature of interventions and inconsistencies in outcomes reported. Any evidence that suggested improvements was mostly applicable to patients with moderate dementia, meaning “its applicability to a screen-detected population is uncertain.”
Updating 2014 recommendations
Their statement was based on an evidence report, also published in JAMA, in which a team of researchers reviewed 287 studies that included more than 285,000 older adults; 92 of the studies were newly identified, while the other 195 were carried forward from the 2014 recommendation’s review. The researchers sought the answers to five key questions, carrying over the framework from the previous review.
“Despite the accumulation of new data, the conclusions for these key questions are essentially unchanged from the prior review,” wrote lead author Carrie D. Patnode, PhD, of the Kaiser Permanente Center for Health Research in Portland, Ore., and coauthors.
Of the questions – which concerned the accuracy of screening instruments; the harms of screening; the harms of interventions; and if screening or interventions improved decision making or outcomes for the patient, family/caregiver, or society – moderate evidence was found to support the accuracy of the instruments, treatment with acetylcholinesterase inhibitors and memantine for patients with moderate dementia, and psychoeducation interventions for caregivers of patients with moderate dementia. At the same time, there was moderate evidence of adverse effects from acetylcholinesterase inhibitors and memantine in patients with moderate dementia.
“I think, eventually, there will be sufficient evidence to justify screening, once we have what I call a tiered approach,” Marwan Sabbagh, MD, of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, said in an interview. “The very near future will include blood tests for Alzheimer’s, or PET scans, or genetics, or something else. Right now, the cognitive screens lack the specificity and sensitivity, and the secondary screening infrastructure that would improve the accuracy doesn’t exist yet.
“I think this is a ‘not now,’ ” he added, “but I wouldn’t say ‘not ever.’ ”
Dr. Patnode and coauthors noted specific limitations in the evidence, including a lack of studies on how screening for and treating cognitive impairment affects decision making. In addition, details like quality of life and institutionalization were inconsistently reported, and “consistent and standardized reporting of results according to meaningful thresholds of clinical significance” would have been valuable across all measures.
Clinical implications
The implications of this report’s conclusions are substantial, especially as the rising prevalence of mild cognitive impairment and dementia becomes a worldwide concern, wrote Ronald C. Petersen, PhD, MD, of the Mayo Clinic in Rochester, Minn., and Kristine Yaffe, MD, of the University of California, San Francisco, in an accompanying editorial.
Though the data does not explicitly support screening, Dr. Petersen and Dr. Yaffe noted that it still may have benefits. An estimated 10% of cognitive impairment is caused by at least somewhat reversible causes, and screening could also be used to improve care in medical problems that are worsened by cognitive impairment. To find the true value of these efforts, they wrote, researchers need to design and execute additional clinical trials that “answer many of the important questions surrounding screening and treatment of cognitive impairment.”
“The absence of evidence for benefit may lead to inaction,” they added, noting that clinicians screening should still consider the value of screening on a case-by-case basis in order to keep up with the impact of new disease-modifying therapies for certain neurodegenerative diseases.
All members of the USPSTF received travel reimbursement and an honorarium for participating in meetings. One member reported receiving grants and personal fees from Healthwise. The study was funded by the Department of Health & Human Services. One of the authors reported receiving grants from the National Institutes of Health and the Food and Drug Administration. Dr. Petersen and Dr. Yaffe reported consulting for, and receiving funding from, various pharmaceutical companies, foundations, and government organizations.
SOURCES: Owens DK et al. JAMA. 2020 Feb 25. doi: 10.1001/jama.2020.0435; Patnode CD et al. JAMA. 2020 Feb 25. doi: 10.1001/jama.2019.22258.
The U.S. Preventive Services Task Force has deemed the current evidence “insufficient” to make a recommendation in regard to screening for cognitive impairment in adults aged 65 years or older.
“More research is needed on the effect of screening and early detection of cognitive impairment on important patient, caregiver, and societal outcomes, including decision making, advance planning, and caregiver outcomes,” wrote lead author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the task force. The statement was published in JAMA.
To update a 2014 recommendation from the USPSTF, which also found insufficient evidence to properly assess cognitive screening’s benefits and harms, the task force commissioned a systematic review of studies applicable to community-dwelling older adults who are not exhibiting signs or symptoms of cognitive impairment. For their statement, “cognitive impairment” is defined as mild cognitive impairment and mild to moderate dementia.
Ultimately, they determined several factors that limited the overall evidence, including the short duration of most trials and the heterogenous nature of interventions and inconsistencies in outcomes reported. Any evidence that suggested improvements was mostly applicable to patients with moderate dementia, meaning “its applicability to a screen-detected population is uncertain.”
Updating 2014 recommendations
Their statement was based on an evidence report, also published in JAMA, in which a team of researchers reviewed 287 studies that included more than 285,000 older adults; 92 of the studies were newly identified, while the other 195 were carried forward from the 2014 recommendation’s review. The researchers sought the answers to five key questions, carrying over the framework from the previous review.
“Despite the accumulation of new data, the conclusions for these key questions are essentially unchanged from the prior review,” wrote lead author Carrie D. Patnode, PhD, of the Kaiser Permanente Center for Health Research in Portland, Ore., and coauthors.
Of the questions – which concerned the accuracy of screening instruments; the harms of screening; the harms of interventions; and if screening or interventions improved decision making or outcomes for the patient, family/caregiver, or society – moderate evidence was found to support the accuracy of the instruments, treatment with acetylcholinesterase inhibitors and memantine for patients with moderate dementia, and psychoeducation interventions for caregivers of patients with moderate dementia. At the same time, there was moderate evidence of adverse effects from acetylcholinesterase inhibitors and memantine in patients with moderate dementia.
“I think, eventually, there will be sufficient evidence to justify screening, once we have what I call a tiered approach,” Marwan Sabbagh, MD, of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, said in an interview. “The very near future will include blood tests for Alzheimer’s, or PET scans, or genetics, or something else. Right now, the cognitive screens lack the specificity and sensitivity, and the secondary screening infrastructure that would improve the accuracy doesn’t exist yet.
“I think this is a ‘not now,’ ” he added, “but I wouldn’t say ‘not ever.’ ”
Dr. Patnode and coauthors noted specific limitations in the evidence, including a lack of studies on how screening for and treating cognitive impairment affects decision making. In addition, details like quality of life and institutionalization were inconsistently reported, and “consistent and standardized reporting of results according to meaningful thresholds of clinical significance” would have been valuable across all measures.
Clinical implications
The implications of this report’s conclusions are substantial, especially as the rising prevalence of mild cognitive impairment and dementia becomes a worldwide concern, wrote Ronald C. Petersen, PhD, MD, of the Mayo Clinic in Rochester, Minn., and Kristine Yaffe, MD, of the University of California, San Francisco, in an accompanying editorial.
Though the data does not explicitly support screening, Dr. Petersen and Dr. Yaffe noted that it still may have benefits. An estimated 10% of cognitive impairment is caused by at least somewhat reversible causes, and screening could also be used to improve care in medical problems that are worsened by cognitive impairment. To find the true value of these efforts, they wrote, researchers need to design and execute additional clinical trials that “answer many of the important questions surrounding screening and treatment of cognitive impairment.”
“The absence of evidence for benefit may lead to inaction,” they added, noting that clinicians screening should still consider the value of screening on a case-by-case basis in order to keep up with the impact of new disease-modifying therapies for certain neurodegenerative diseases.
All members of the USPSTF received travel reimbursement and an honorarium for participating in meetings. One member reported receiving grants and personal fees from Healthwise. The study was funded by the Department of Health & Human Services. One of the authors reported receiving grants from the National Institutes of Health and the Food and Drug Administration. Dr. Petersen and Dr. Yaffe reported consulting for, and receiving funding from, various pharmaceutical companies, foundations, and government organizations.
SOURCES: Owens DK et al. JAMA. 2020 Feb 25. doi: 10.1001/jama.2020.0435; Patnode CD et al. JAMA. 2020 Feb 25. doi: 10.1001/jama.2019.22258.
FROM JAMA
FDA approves first IV migraine prevention drug
As previously reported by Medscape Medical News, the drug’s approval is based on results from two clinical studies – PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
The recommended dose is 100 mg every 3 months although some patients may benefit from a dose of 300 mg, the company notes. Lundbeck reports that the drug will likely be available in early April.
Roger Cady, MD, vice-president of neurology at Lundbeck, told Medscape Medical News the drug has almost immediate efficacy.
“Because it’s an IV [medication], it has very rapid benefit. In fact, we were able to demonstrate benefit on Day 1. Truly, it is going to impact on the unmet need for patients because of its profile, the way it’s delivered, and its uniqueness,” Cady said.
“Having preventive activity the day following an infusion is really important. We have in our data, if you take that time between the first day and the 28th day, whether they have episodic migraine or chronic migraine, that about 30% of the population had a 75% or more reduction in migraine days through that first month,” he added.
The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days, the company reports.
The safety of Vyepti was evaluated in 2076 patients with migraine who received at least one dose of the drug. The most common adverse reactions were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment as a result of adverse reactions.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter Goadsby, MD, professor of neurology at King’s College, London, UK, and the University of California, San Francisco, in a press release. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
This article first appeared on Medscape.com.
As previously reported by Medscape Medical News, the drug’s approval is based on results from two clinical studies – PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
The recommended dose is 100 mg every 3 months although some patients may benefit from a dose of 300 mg, the company notes. Lundbeck reports that the drug will likely be available in early April.
Roger Cady, MD, vice-president of neurology at Lundbeck, told Medscape Medical News the drug has almost immediate efficacy.
“Because it’s an IV [medication], it has very rapid benefit. In fact, we were able to demonstrate benefit on Day 1. Truly, it is going to impact on the unmet need for patients because of its profile, the way it’s delivered, and its uniqueness,” Cady said.
“Having preventive activity the day following an infusion is really important. We have in our data, if you take that time between the first day and the 28th day, whether they have episodic migraine or chronic migraine, that about 30% of the population had a 75% or more reduction in migraine days through that first month,” he added.
The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days, the company reports.
The safety of Vyepti was evaluated in 2076 patients with migraine who received at least one dose of the drug. The most common adverse reactions were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment as a result of adverse reactions.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter Goadsby, MD, professor of neurology at King’s College, London, UK, and the University of California, San Francisco, in a press release. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
This article first appeared on Medscape.com.
As previously reported by Medscape Medical News, the drug’s approval is based on results from two clinical studies – PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
The recommended dose is 100 mg every 3 months although some patients may benefit from a dose of 300 mg, the company notes. Lundbeck reports that the drug will likely be available in early April.
Roger Cady, MD, vice-president of neurology at Lundbeck, told Medscape Medical News the drug has almost immediate efficacy.
“Because it’s an IV [medication], it has very rapid benefit. In fact, we were able to demonstrate benefit on Day 1. Truly, it is going to impact on the unmet need for patients because of its profile, the way it’s delivered, and its uniqueness,” Cady said.
“Having preventive activity the day following an infusion is really important. We have in our data, if you take that time between the first day and the 28th day, whether they have episodic migraine or chronic migraine, that about 30% of the population had a 75% or more reduction in migraine days through that first month,” he added.
The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days, the company reports.
The safety of Vyepti was evaluated in 2076 patients with migraine who received at least one dose of the drug. The most common adverse reactions were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment as a result of adverse reactions.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter Goadsby, MD, professor of neurology at King’s College, London, UK, and the University of California, San Francisco, in a press release. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
This article first appeared on Medscape.com.
FROM MEDSCAPE.COM
Transporting the high-risk psychiatric patient: Clinical and legal challenges
“I’ve given up, doctor. We gave it our best, but I am at the point where I want to end my life.” You receive this call at 2 a.m., and you’re flooded with a series of emotions and are bewildered – until your training kicks in.
Countless hours of working with patients in emergency department settings while on call as a resident inform your ability to triage the situation. Years of supervision guide your supportive statements as you work collaboratively with your patient to address the emotional and existential distress. As the call proceeds and you realize that your patient will require hospitalization, you are struck by a sobering question: “How am I going to arrange for my patient to go to the nearest hospital in the middle of the night?”
The options for transporting patients with serious mental illness (SMI) typically vary from bad to worse and usually filter down to three possibilities:
1. Get a friend or family member to transport them to the nearest ED.
2. Call emergency medical services (EMS) for transport to the nearest ED.
3. Call the police and request transport to the nearest ED.
Several factors would determine which of those options you would use alone or in combination. Current training paradigms for mental health professionals offer a limited body of literature on evidenced-based strategies for patients with SMI. At best – if not handled properly – these experiences can aggravate patients’ mental health conditions. At worst, they can lead to the loss of our patients. Together, we have more than 40 years’ experience working in complex mental health care systems that run the gamut, from providing direct clinical care to directing mental health care divisions.
Sobering statistics prevail
In 2017, suicide was the 10th leading cause of death in the United States, accounting for more than 47,000 deaths. Suicide was the second-leading cause of death among individuals aged 10-34 and the fourth leading cause of death for individuals aged 35- 54.1 In 2017, more than 70,200 Americans died from a drug overdose, including illicit drugs and prescription opioids.2 Drug overdose deaths nearly quadrupled between 1999 and 2017, from 16,849 deaths to 70,237, respectively.2
The life expectancy of an American with SMI is 14-32 years less than that of the average population.3 Those numbers are on par with many sub-Saharan countries, including Sudan and Ethiopia, and surpass the health disparities for most racial and ethnic groups.
The decrease in life expectancy for people with SMI is rarely the result of suicide but rather the effect of medical comorbidities, including heart disease, stroke, pulmonary disease, diabetes, and cancer.3 Individuals with SMI are much more likely to suffer from chronic illnesses that are associated with co-occurring addictions, side effects of psychotropic medications, and social determinants of mental health, such as poverty.
Major depressive disorder among people with SMI presents acute and chronic medical risks. For example, people with major depressive disorder are at a higher risk for stroke and cardiovascular disease.4 There is a threefold increase in cardiac-related deaths for individuals who experience depression after a heart attack.5 In addition, depression increases the risk of cardiac-related death after a heart attack more than any other risk factor, except for congestive heart failure.6
The transportation challenge
When the complexity of psychiatric conditions is conceptualized to include decreased life expectancy because of medical comorbidities, medical complications that can result from psychotropic medications, and the high incidence of co-occurring substance use disorders (SUDs), it is clear why we are concerned about the type of transport used for patients experiencing a psychiatric emergency.
A common practice for patients presenting for medical treatment for a mental health condition is for them to be transported by law enforcement in handcuffs, or by private vehicle, because of a lack of medical transport options.
One tragic example occurred on Sept. 18, 2018, when two Horry County, S.C., deputies were providing a hospital-to-hospital transport for two mental health patients. The patients, who had no legal charges and were not under arrest, were locked in a transport cage in the back of a law enforcement vehicle for transport during Hurricane Florence. While the driver tried to move through floodwaters, the car stalled and became submerged. The patients were unable to open the locked cage door, and the deputies responsible for the transport did not have a key to unlock the cage.
The two women died as a result of the incident. Both deputies are facing two counts of involuntary manslaughter – with a potential prison sentence of 5 years each.7
The system that promotes the use of law enforcement to transport medical patients who are not in legal custody perpetuates a high risk to patients. Also at risk are law enforcement professionals who often are not adequately trained to evaluate, intervene, and manage patients in need of medical treatment (for acute medical, SUDs, or mental illness).
Recommendations for transporting high-risk patients
The legal and regulatory standards required by the Centers for Medicare & Medicaid Services guidelines8 for behavioral health patients are consistent in saying that law enforcement restraints cannot be used in hospital settings – unless the patient is under law enforcement custody. If the patient is admitted to an inpatient psychiatric unit, law enforcement restraints are never allowed to be used. Despite those guidelines for handling these situations within hospital settings, a similar standard does not exist for interhospital transport of high-risk behavioral health patients.
Patients often are transported between facilities by law enforcement, and at times, with the use of law enforcement restraints. However, use of law enforcement for interhospital transport of patients not in the custody of law enforcement is both detrimental to and clinically dangerous for the patient. Not only does the scenario put the patient at risk, but it also places law enforcement professionals at risk with the potential for legal liability if the patient medically decompensates during the transport.
Also, using law enforcement to intervene and provide transportation for behavioral health patients in crisis might cause further harm to the patient’s psychological condition and deter the patient from presenting for treatment.
The appropriate level of interfacility transport for a behavioral health patient requiring an inpatient level of care is secure transport with trained medical professionals. If necessary, restraint guidelines should follow the same standard as they do in hospital settings. In situations with high risk for violence or agitation, law enforcement should be requested to accompany EMS during the transport. Handling the situation in this way allows for a collaborative approach to provide adequate medical support, and provide for the physical safety and security of the patient – and of EMS personnel.
Across police and sheriffs’ departments nationwide, law enforcement officers are required to transport mental health patients from one location or hospital to another. Hospitals and outpatient locations, often with no alternative, rely on local law enforcement agencies to provide safe transport between acute and mental health facilities. Departmental policies and the widespread belief that mental health patients automatically pose a substantial danger to themselves or others have led to these patients being handcuffed and put in the back of police cruisers. Essentially, they are treated like criminals who are under arrest.
The CMS has strict criteria for ordering, applying, evaluating, reevaluating, and reporting restraint-associated deaths. Likewise, The Joint Commission, during its accreditation survey, rightly scrutinizes a facility’s use of restraints. Both the CMS and The Joint Commission define restraint by the function of the device and not the type of the device.
According to the CMS, a restraint is any manual method, physical or mechanic device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. Within a police cruiser, handcuffs on a mental health patient who is not under arrest would fall squarely within this definition of restraint.
A patient’s current behavior or clinical needs – not history or diagnosis – should determine whether a restraint is warranted. A patient experiencing a psychiatric crisis who is not under arrest might very well escalate and become destructive and combative when being placed in handcuffs in the back of a police vehicle. What should police do at that point? Should they arrest the individual? We offer the following five recommendations.
Key recommendations
- Patients who require interhospital transport for an acute behavioral health crisis should be transported by medical professionals with the training and expertise to manage mental health and medical conditions.
- Interhospital transport restraint guidelines should be in line with CMS guidelines for hospital restraints. No patient that is not under law enforcement custody should be transported in law enforcement restraints.
- Patients at high risk for violence/agitation (an underlying condition causing violence/agitation may include dementia, traumatic brain injuries, delirium, SUDs, or psychiatric conditions) should be managed in accordance with medically indicated intervention such as medical restraints or medications.
- If required, a request should be made for law enforcement officers to accompany EMS to provide support and to ensure the safety of the patient and EMS professionals during the transport.
- EMS professionals should receive specific training to manage acute psychiatric and SUD conditions, and should be aware of the life-threatening medical complications that can result from SUDs and psychiatric conditions/medications.
We recognize that patients with SMI require clinicians to work collaboratively, perhaps with law enforcement, to safely transport them from one point to another. Only when the rules we have outlined are followed will our patients get transported in such ways that allow them to get the care they need.
Dr. Norris is editor-in-chief of MDedge Psychiatry, and assistant professor of psychiatry and behavioral sciences at George Washington University, Washington. He serves as assistant dean of student affairs at the university, and medical director of psychiatric and behavioral sciences at GWU Hospital. Ms. Palmieri is a managing partner of Healthcare Legal Education & Consulting Network (HLECN), and the chief clinical officer and cofounder of XFERALL. HLECN focuses on clinical education and training, and XFERALL is a company that provides a technology platform aimed at improving access to care for behavioral health and medical patients. Ms. Slater is a managing partner of legal education for HLECN, and a trial attorney at Colley Shroyer & Abraham in Columbus, Ohio. Mr. Whaley is director of the safety and security department at GWU Hospital.
References
1. National Institute of Mental Health: Suicide.
2. National Institute on Drug Abuse. Overdose death rates. Revised January 2019.
3. Post by former NIMH Director Thomas Insel: No health without mental health. Sept. 6, 2011.
4. Dhar AK and Barton DA. Depression and the link with cardiovascular disease. Front Psychiatry. 2016 Mar 21;7:33.
5. Lichtman JH et al. Depression and coronary heart disease. Circulation. 2008;118:1768-75.
6. Hare DL et al. Depression and cardiovascular disease: A clinical review. European Heart J. 2014 Jun;35(21):1365-72.
7. “ ‘How many people have to die?’ SC mental health patients endure nightmare transport.” The News & Observer. 2019 May 29.
8. 42 C.F.R. Part 482. Part IV. Department of Health and Human Services. Medicare & Medicaid programs; Hospital conditions of participation; Patients’ rights; Final rule. 2006 Dec 8.
“I’ve given up, doctor. We gave it our best, but I am at the point where I want to end my life.” You receive this call at 2 a.m., and you’re flooded with a series of emotions and are bewildered – until your training kicks in.
Countless hours of working with patients in emergency department settings while on call as a resident inform your ability to triage the situation. Years of supervision guide your supportive statements as you work collaboratively with your patient to address the emotional and existential distress. As the call proceeds and you realize that your patient will require hospitalization, you are struck by a sobering question: “How am I going to arrange for my patient to go to the nearest hospital in the middle of the night?”
The options for transporting patients with serious mental illness (SMI) typically vary from bad to worse and usually filter down to three possibilities:
1. Get a friend or family member to transport them to the nearest ED.
2. Call emergency medical services (EMS) for transport to the nearest ED.
3. Call the police and request transport to the nearest ED.
Several factors would determine which of those options you would use alone or in combination. Current training paradigms for mental health professionals offer a limited body of literature on evidenced-based strategies for patients with SMI. At best – if not handled properly – these experiences can aggravate patients’ mental health conditions. At worst, they can lead to the loss of our patients. Together, we have more than 40 years’ experience working in complex mental health care systems that run the gamut, from providing direct clinical care to directing mental health care divisions.
Sobering statistics prevail
In 2017, suicide was the 10th leading cause of death in the United States, accounting for more than 47,000 deaths. Suicide was the second-leading cause of death among individuals aged 10-34 and the fourth leading cause of death for individuals aged 35- 54.1 In 2017, more than 70,200 Americans died from a drug overdose, including illicit drugs and prescription opioids.2 Drug overdose deaths nearly quadrupled between 1999 and 2017, from 16,849 deaths to 70,237, respectively.2
The life expectancy of an American with SMI is 14-32 years less than that of the average population.3 Those numbers are on par with many sub-Saharan countries, including Sudan and Ethiopia, and surpass the health disparities for most racial and ethnic groups.
The decrease in life expectancy for people with SMI is rarely the result of suicide but rather the effect of medical comorbidities, including heart disease, stroke, pulmonary disease, diabetes, and cancer.3 Individuals with SMI are much more likely to suffer from chronic illnesses that are associated with co-occurring addictions, side effects of psychotropic medications, and social determinants of mental health, such as poverty.
Major depressive disorder among people with SMI presents acute and chronic medical risks. For example, people with major depressive disorder are at a higher risk for stroke and cardiovascular disease.4 There is a threefold increase in cardiac-related deaths for individuals who experience depression after a heart attack.5 In addition, depression increases the risk of cardiac-related death after a heart attack more than any other risk factor, except for congestive heart failure.6
The transportation challenge
When the complexity of psychiatric conditions is conceptualized to include decreased life expectancy because of medical comorbidities, medical complications that can result from psychotropic medications, and the high incidence of co-occurring substance use disorders (SUDs), it is clear why we are concerned about the type of transport used for patients experiencing a psychiatric emergency.
A common practice for patients presenting for medical treatment for a mental health condition is for them to be transported by law enforcement in handcuffs, or by private vehicle, because of a lack of medical transport options.
One tragic example occurred on Sept. 18, 2018, when two Horry County, S.C., deputies were providing a hospital-to-hospital transport for two mental health patients. The patients, who had no legal charges and were not under arrest, were locked in a transport cage in the back of a law enforcement vehicle for transport during Hurricane Florence. While the driver tried to move through floodwaters, the car stalled and became submerged. The patients were unable to open the locked cage door, and the deputies responsible for the transport did not have a key to unlock the cage.
The two women died as a result of the incident. Both deputies are facing two counts of involuntary manslaughter – with a potential prison sentence of 5 years each.7
The system that promotes the use of law enforcement to transport medical patients who are not in legal custody perpetuates a high risk to patients. Also at risk are law enforcement professionals who often are not adequately trained to evaluate, intervene, and manage patients in need of medical treatment (for acute medical, SUDs, or mental illness).
Recommendations for transporting high-risk patients
The legal and regulatory standards required by the Centers for Medicare & Medicaid Services guidelines8 for behavioral health patients are consistent in saying that law enforcement restraints cannot be used in hospital settings – unless the patient is under law enforcement custody. If the patient is admitted to an inpatient psychiatric unit, law enforcement restraints are never allowed to be used. Despite those guidelines for handling these situations within hospital settings, a similar standard does not exist for interhospital transport of high-risk behavioral health patients.
Patients often are transported between facilities by law enforcement, and at times, with the use of law enforcement restraints. However, use of law enforcement for interhospital transport of patients not in the custody of law enforcement is both detrimental to and clinically dangerous for the patient. Not only does the scenario put the patient at risk, but it also places law enforcement professionals at risk with the potential for legal liability if the patient medically decompensates during the transport.
Also, using law enforcement to intervene and provide transportation for behavioral health patients in crisis might cause further harm to the patient’s psychological condition and deter the patient from presenting for treatment.
The appropriate level of interfacility transport for a behavioral health patient requiring an inpatient level of care is secure transport with trained medical professionals. If necessary, restraint guidelines should follow the same standard as they do in hospital settings. In situations with high risk for violence or agitation, law enforcement should be requested to accompany EMS during the transport. Handling the situation in this way allows for a collaborative approach to provide adequate medical support, and provide for the physical safety and security of the patient – and of EMS personnel.
Across police and sheriffs’ departments nationwide, law enforcement officers are required to transport mental health patients from one location or hospital to another. Hospitals and outpatient locations, often with no alternative, rely on local law enforcement agencies to provide safe transport between acute and mental health facilities. Departmental policies and the widespread belief that mental health patients automatically pose a substantial danger to themselves or others have led to these patients being handcuffed and put in the back of police cruisers. Essentially, they are treated like criminals who are under arrest.
The CMS has strict criteria for ordering, applying, evaluating, reevaluating, and reporting restraint-associated deaths. Likewise, The Joint Commission, during its accreditation survey, rightly scrutinizes a facility’s use of restraints. Both the CMS and The Joint Commission define restraint by the function of the device and not the type of the device.
According to the CMS, a restraint is any manual method, physical or mechanic device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. Within a police cruiser, handcuffs on a mental health patient who is not under arrest would fall squarely within this definition of restraint.
A patient’s current behavior or clinical needs – not history or diagnosis – should determine whether a restraint is warranted. A patient experiencing a psychiatric crisis who is not under arrest might very well escalate and become destructive and combative when being placed in handcuffs in the back of a police vehicle. What should police do at that point? Should they arrest the individual? We offer the following five recommendations.
Key recommendations
- Patients who require interhospital transport for an acute behavioral health crisis should be transported by medical professionals with the training and expertise to manage mental health and medical conditions.
- Interhospital transport restraint guidelines should be in line with CMS guidelines for hospital restraints. No patient that is not under law enforcement custody should be transported in law enforcement restraints.
- Patients at high risk for violence/agitation (an underlying condition causing violence/agitation may include dementia, traumatic brain injuries, delirium, SUDs, or psychiatric conditions) should be managed in accordance with medically indicated intervention such as medical restraints or medications.
- If required, a request should be made for law enforcement officers to accompany EMS to provide support and to ensure the safety of the patient and EMS professionals during the transport.
- EMS professionals should receive specific training to manage acute psychiatric and SUD conditions, and should be aware of the life-threatening medical complications that can result from SUDs and psychiatric conditions/medications.
We recognize that patients with SMI require clinicians to work collaboratively, perhaps with law enforcement, to safely transport them from one point to another. Only when the rules we have outlined are followed will our patients get transported in such ways that allow them to get the care they need.
Dr. Norris is editor-in-chief of MDedge Psychiatry, and assistant professor of psychiatry and behavioral sciences at George Washington University, Washington. He serves as assistant dean of student affairs at the university, and medical director of psychiatric and behavioral sciences at GWU Hospital. Ms. Palmieri is a managing partner of Healthcare Legal Education & Consulting Network (HLECN), and the chief clinical officer and cofounder of XFERALL. HLECN focuses on clinical education and training, and XFERALL is a company that provides a technology platform aimed at improving access to care for behavioral health and medical patients. Ms. Slater is a managing partner of legal education for HLECN, and a trial attorney at Colley Shroyer & Abraham in Columbus, Ohio. Mr. Whaley is director of the safety and security department at GWU Hospital.
References
1. National Institute of Mental Health: Suicide.
2. National Institute on Drug Abuse. Overdose death rates. Revised January 2019.
3. Post by former NIMH Director Thomas Insel: No health without mental health. Sept. 6, 2011.
4. Dhar AK and Barton DA. Depression and the link with cardiovascular disease. Front Psychiatry. 2016 Mar 21;7:33.
5. Lichtman JH et al. Depression and coronary heart disease. Circulation. 2008;118:1768-75.
6. Hare DL et al. Depression and cardiovascular disease: A clinical review. European Heart J. 2014 Jun;35(21):1365-72.
7. “ ‘How many people have to die?’ SC mental health patients endure nightmare transport.” The News & Observer. 2019 May 29.
8. 42 C.F.R. Part 482. Part IV. Department of Health and Human Services. Medicare & Medicaid programs; Hospital conditions of participation; Patients’ rights; Final rule. 2006 Dec 8.
“I’ve given up, doctor. We gave it our best, but I am at the point where I want to end my life.” You receive this call at 2 a.m., and you’re flooded with a series of emotions and are bewildered – until your training kicks in.
Countless hours of working with patients in emergency department settings while on call as a resident inform your ability to triage the situation. Years of supervision guide your supportive statements as you work collaboratively with your patient to address the emotional and existential distress. As the call proceeds and you realize that your patient will require hospitalization, you are struck by a sobering question: “How am I going to arrange for my patient to go to the nearest hospital in the middle of the night?”
The options for transporting patients with serious mental illness (SMI) typically vary from bad to worse and usually filter down to three possibilities:
1. Get a friend or family member to transport them to the nearest ED.
2. Call emergency medical services (EMS) for transport to the nearest ED.
3. Call the police and request transport to the nearest ED.
Several factors would determine which of those options you would use alone or in combination. Current training paradigms for mental health professionals offer a limited body of literature on evidenced-based strategies for patients with SMI. At best – if not handled properly – these experiences can aggravate patients’ mental health conditions. At worst, they can lead to the loss of our patients. Together, we have more than 40 years’ experience working in complex mental health care systems that run the gamut, from providing direct clinical care to directing mental health care divisions.
Sobering statistics prevail
In 2017, suicide was the 10th leading cause of death in the United States, accounting for more than 47,000 deaths. Suicide was the second-leading cause of death among individuals aged 10-34 and the fourth leading cause of death for individuals aged 35- 54.1 In 2017, more than 70,200 Americans died from a drug overdose, including illicit drugs and prescription opioids.2 Drug overdose deaths nearly quadrupled between 1999 and 2017, from 16,849 deaths to 70,237, respectively.2
The life expectancy of an American with SMI is 14-32 years less than that of the average population.3 Those numbers are on par with many sub-Saharan countries, including Sudan and Ethiopia, and surpass the health disparities for most racial and ethnic groups.
The decrease in life expectancy for people with SMI is rarely the result of suicide but rather the effect of medical comorbidities, including heart disease, stroke, pulmonary disease, diabetes, and cancer.3 Individuals with SMI are much more likely to suffer from chronic illnesses that are associated with co-occurring addictions, side effects of psychotropic medications, and social determinants of mental health, such as poverty.
Major depressive disorder among people with SMI presents acute and chronic medical risks. For example, people with major depressive disorder are at a higher risk for stroke and cardiovascular disease.4 There is a threefold increase in cardiac-related deaths for individuals who experience depression after a heart attack.5 In addition, depression increases the risk of cardiac-related death after a heart attack more than any other risk factor, except for congestive heart failure.6
The transportation challenge
When the complexity of psychiatric conditions is conceptualized to include decreased life expectancy because of medical comorbidities, medical complications that can result from psychotropic medications, and the high incidence of co-occurring substance use disorders (SUDs), it is clear why we are concerned about the type of transport used for patients experiencing a psychiatric emergency.
A common practice for patients presenting for medical treatment for a mental health condition is for them to be transported by law enforcement in handcuffs, or by private vehicle, because of a lack of medical transport options.
One tragic example occurred on Sept. 18, 2018, when two Horry County, S.C., deputies were providing a hospital-to-hospital transport for two mental health patients. The patients, who had no legal charges and were not under arrest, were locked in a transport cage in the back of a law enforcement vehicle for transport during Hurricane Florence. While the driver tried to move through floodwaters, the car stalled and became submerged. The patients were unable to open the locked cage door, and the deputies responsible for the transport did not have a key to unlock the cage.
The two women died as a result of the incident. Both deputies are facing two counts of involuntary manslaughter – with a potential prison sentence of 5 years each.7
The system that promotes the use of law enforcement to transport medical patients who are not in legal custody perpetuates a high risk to patients. Also at risk are law enforcement professionals who often are not adequately trained to evaluate, intervene, and manage patients in need of medical treatment (for acute medical, SUDs, or mental illness).
Recommendations for transporting high-risk patients
The legal and regulatory standards required by the Centers for Medicare & Medicaid Services guidelines8 for behavioral health patients are consistent in saying that law enforcement restraints cannot be used in hospital settings – unless the patient is under law enforcement custody. If the patient is admitted to an inpatient psychiatric unit, law enforcement restraints are never allowed to be used. Despite those guidelines for handling these situations within hospital settings, a similar standard does not exist for interhospital transport of high-risk behavioral health patients.
Patients often are transported between facilities by law enforcement, and at times, with the use of law enforcement restraints. However, use of law enforcement for interhospital transport of patients not in the custody of law enforcement is both detrimental to and clinically dangerous for the patient. Not only does the scenario put the patient at risk, but it also places law enforcement professionals at risk with the potential for legal liability if the patient medically decompensates during the transport.
Also, using law enforcement to intervene and provide transportation for behavioral health patients in crisis might cause further harm to the patient’s psychological condition and deter the patient from presenting for treatment.
The appropriate level of interfacility transport for a behavioral health patient requiring an inpatient level of care is secure transport with trained medical professionals. If necessary, restraint guidelines should follow the same standard as they do in hospital settings. In situations with high risk for violence or agitation, law enforcement should be requested to accompany EMS during the transport. Handling the situation in this way allows for a collaborative approach to provide adequate medical support, and provide for the physical safety and security of the patient – and of EMS personnel.
Across police and sheriffs’ departments nationwide, law enforcement officers are required to transport mental health patients from one location or hospital to another. Hospitals and outpatient locations, often with no alternative, rely on local law enforcement agencies to provide safe transport between acute and mental health facilities. Departmental policies and the widespread belief that mental health patients automatically pose a substantial danger to themselves or others have led to these patients being handcuffed and put in the back of police cruisers. Essentially, they are treated like criminals who are under arrest.
The CMS has strict criteria for ordering, applying, evaluating, reevaluating, and reporting restraint-associated deaths. Likewise, The Joint Commission, during its accreditation survey, rightly scrutinizes a facility’s use of restraints. Both the CMS and The Joint Commission define restraint by the function of the device and not the type of the device.
According to the CMS, a restraint is any manual method, physical or mechanic device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. Within a police cruiser, handcuffs on a mental health patient who is not under arrest would fall squarely within this definition of restraint.
A patient’s current behavior or clinical needs – not history or diagnosis – should determine whether a restraint is warranted. A patient experiencing a psychiatric crisis who is not under arrest might very well escalate and become destructive and combative when being placed in handcuffs in the back of a police vehicle. What should police do at that point? Should they arrest the individual? We offer the following five recommendations.
Key recommendations
- Patients who require interhospital transport for an acute behavioral health crisis should be transported by medical professionals with the training and expertise to manage mental health and medical conditions.
- Interhospital transport restraint guidelines should be in line with CMS guidelines for hospital restraints. No patient that is not under law enforcement custody should be transported in law enforcement restraints.
- Patients at high risk for violence/agitation (an underlying condition causing violence/agitation may include dementia, traumatic brain injuries, delirium, SUDs, or psychiatric conditions) should be managed in accordance with medically indicated intervention such as medical restraints or medications.
- If required, a request should be made for law enforcement officers to accompany EMS to provide support and to ensure the safety of the patient and EMS professionals during the transport.
- EMS professionals should receive specific training to manage acute psychiatric and SUD conditions, and should be aware of the life-threatening medical complications that can result from SUDs and psychiatric conditions/medications.
We recognize that patients with SMI require clinicians to work collaboratively, perhaps with law enforcement, to safely transport them from one point to another. Only when the rules we have outlined are followed will our patients get transported in such ways that allow them to get the care they need.
Dr. Norris is editor-in-chief of MDedge Psychiatry, and assistant professor of psychiatry and behavioral sciences at George Washington University, Washington. He serves as assistant dean of student affairs at the university, and medical director of psychiatric and behavioral sciences at GWU Hospital. Ms. Palmieri is a managing partner of Healthcare Legal Education & Consulting Network (HLECN), and the chief clinical officer and cofounder of XFERALL. HLECN focuses on clinical education and training, and XFERALL is a company that provides a technology platform aimed at improving access to care for behavioral health and medical patients. Ms. Slater is a managing partner of legal education for HLECN, and a trial attorney at Colley Shroyer & Abraham in Columbus, Ohio. Mr. Whaley is director of the safety and security department at GWU Hospital.
References
1. National Institute of Mental Health: Suicide.
2. National Institute on Drug Abuse. Overdose death rates. Revised January 2019.
3. Post by former NIMH Director Thomas Insel: No health without mental health. Sept. 6, 2011.
4. Dhar AK and Barton DA. Depression and the link with cardiovascular disease. Front Psychiatry. 2016 Mar 21;7:33.
5. Lichtman JH et al. Depression and coronary heart disease. Circulation. 2008;118:1768-75.
6. Hare DL et al. Depression and cardiovascular disease: A clinical review. European Heart J. 2014 Jun;35(21):1365-72.
7. “ ‘How many people have to die?’ SC mental health patients endure nightmare transport.” The News & Observer. 2019 May 29.
8. 42 C.F.R. Part 482. Part IV. Department of Health and Human Services. Medicare & Medicaid programs; Hospital conditions of participation; Patients’ rights; Final rule. 2006 Dec 8.
Severe infection tied to substance-induced psychosis, conversion to schizophrenia
Severe infection is linked to an increased risk of substance-induced psychosis and subsequent conversion to schizophrenia, new research suggests.
Results of the large, population-based study showed any infection was associated with a 30% increased risk for substance-induced psychosis. However, with more than a threefold increased risk for substance-induced psychosis, hepatitis was the infection most strongly linked to psychosis and the only infection associated with conversion to schizophrenia.
“Severe infections are associated with an increased risk of developing a substance-induced psychosis. Furthermore, hepatitis following substance-induced psychosis is associated with an increase in the risk of conversion to schizophrenia. Both of these observations support the hypothesis of an immunological component to psychosis,” wrote the investigators, led by Carsten Hjorthøj, PhD, MSc, Copenhagen Research Center for Mental Health, Denmark.
The study was published online Feb. 12 in the American Journal of Psychiatry.
Mechanism still poorly understood
Previous research suggests that infection increases the risk for schizophrenia, but this new study is the first to investigate the association between infection and substance-induced psychosis.
Using Danish national registry data, the researchers analyzed data on all individuals born in Denmark since 1981.
Any infection increased the risk for substance-induced psychosis in the fully-adjusted model (hazard ratio = 1.30; 95% confidence interval, 1.22–1.39; P less than .001). The risk was doubled in the first 2 years following a severe infection and stayed elevated for more than 20 years.
Hepatitis was the infection most strongly associated with substance-induced psychosis (HR = 3.42; 95% CI, 2.47–4.74; P less than .001) and only hepatitis predicted conversion to schizophrenia after substance-induced psychosis (HR = 1.87; 95% CI, 1.07–3.26; P = .03).
These results, the investigators note, “mirror previous findings on the association between infections and schizophrenia, including previous observations that the link is particularly strong for hepatitis.”
They also point out that the biological mechanisms through which infections would increase the risk for psychosis, including substance-induced psychosis, remain poorly understood.
“If the exact mechanisms underlying the psychotogenic properties of infections or the immune response can be identified, this is likely to lead to improvements in treatment for psychotic disorders. A further hope is that it may even be possible to use this knowledge for primary prevention of psychosis,” the authors wrote.
Interpret with caution
Commenting on the study, Ole Köhler-Forsberg, MD, from the Psychosis Research Unit, Aarhus University Hospital, Denmark, said in an interview that the findings support a potential immunologic link to schizophrenia.
“However,” he added, “as in every register-based study, no causality can be assumed, only associations. As mentioned by the authors, there may be residual confounding and confounding by indication.”
Also commenting on the study, René Kahn, MD, PhD, professor and chair of psychiatry at the Icahn School of Medicine at Mount Sinai in New York, noted in an interview that there is a lot of “indirect evidence” from epidemiologic studies like this one to suggest an immune component to psychosis.
“However, there is not a single piece of direct evidence linking the immune system to schizophrenia so far,” Dr. Kahn cautioned.
“Yes, people who have hepatitis have a higher risk of developing substance-induced psychosis, but this may be a spurious finding. It may very well be that people who are prone to hepatitis for whatever reasons are at higher risk for psychosis but there is no direct evidence that the two are related. This study doesn’t convince me at all that immune pathology is related to schizophrenia,” Dr. Kahn said.
The study was supported by a grant from the Lundbeck Foundation Initiative for Integrative Psychiatric Research (iPSYCH). The study authors, Dr. Kahn, and Dr. Köhler-Forsberg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Severe infection is linked to an increased risk of substance-induced psychosis and subsequent conversion to schizophrenia, new research suggests.
Results of the large, population-based study showed any infection was associated with a 30% increased risk for substance-induced psychosis. However, with more than a threefold increased risk for substance-induced psychosis, hepatitis was the infection most strongly linked to psychosis and the only infection associated with conversion to schizophrenia.
“Severe infections are associated with an increased risk of developing a substance-induced psychosis. Furthermore, hepatitis following substance-induced psychosis is associated with an increase in the risk of conversion to schizophrenia. Both of these observations support the hypothesis of an immunological component to psychosis,” wrote the investigators, led by Carsten Hjorthøj, PhD, MSc, Copenhagen Research Center for Mental Health, Denmark.
The study was published online Feb. 12 in the American Journal of Psychiatry.
Mechanism still poorly understood
Previous research suggests that infection increases the risk for schizophrenia, but this new study is the first to investigate the association between infection and substance-induced psychosis.
Using Danish national registry data, the researchers analyzed data on all individuals born in Denmark since 1981.
Any infection increased the risk for substance-induced psychosis in the fully-adjusted model (hazard ratio = 1.30; 95% confidence interval, 1.22–1.39; P less than .001). The risk was doubled in the first 2 years following a severe infection and stayed elevated for more than 20 years.
Hepatitis was the infection most strongly associated with substance-induced psychosis (HR = 3.42; 95% CI, 2.47–4.74; P less than .001) and only hepatitis predicted conversion to schizophrenia after substance-induced psychosis (HR = 1.87; 95% CI, 1.07–3.26; P = .03).
These results, the investigators note, “mirror previous findings on the association between infections and schizophrenia, including previous observations that the link is particularly strong for hepatitis.”
They also point out that the biological mechanisms through which infections would increase the risk for psychosis, including substance-induced psychosis, remain poorly understood.
“If the exact mechanisms underlying the psychotogenic properties of infections or the immune response can be identified, this is likely to lead to improvements in treatment for psychotic disorders. A further hope is that it may even be possible to use this knowledge for primary prevention of psychosis,” the authors wrote.
Interpret with caution
Commenting on the study, Ole Köhler-Forsberg, MD, from the Psychosis Research Unit, Aarhus University Hospital, Denmark, said in an interview that the findings support a potential immunologic link to schizophrenia.
“However,” he added, “as in every register-based study, no causality can be assumed, only associations. As mentioned by the authors, there may be residual confounding and confounding by indication.”
Also commenting on the study, René Kahn, MD, PhD, professor and chair of psychiatry at the Icahn School of Medicine at Mount Sinai in New York, noted in an interview that there is a lot of “indirect evidence” from epidemiologic studies like this one to suggest an immune component to psychosis.
“However, there is not a single piece of direct evidence linking the immune system to schizophrenia so far,” Dr. Kahn cautioned.
“Yes, people who have hepatitis have a higher risk of developing substance-induced psychosis, but this may be a spurious finding. It may very well be that people who are prone to hepatitis for whatever reasons are at higher risk for psychosis but there is no direct evidence that the two are related. This study doesn’t convince me at all that immune pathology is related to schizophrenia,” Dr. Kahn said.
The study was supported by a grant from the Lundbeck Foundation Initiative for Integrative Psychiatric Research (iPSYCH). The study authors, Dr. Kahn, and Dr. Köhler-Forsberg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Severe infection is linked to an increased risk of substance-induced psychosis and subsequent conversion to schizophrenia, new research suggests.
Results of the large, population-based study showed any infection was associated with a 30% increased risk for substance-induced psychosis. However, with more than a threefold increased risk for substance-induced psychosis, hepatitis was the infection most strongly linked to psychosis and the only infection associated with conversion to schizophrenia.
“Severe infections are associated with an increased risk of developing a substance-induced psychosis. Furthermore, hepatitis following substance-induced psychosis is associated with an increase in the risk of conversion to schizophrenia. Both of these observations support the hypothesis of an immunological component to psychosis,” wrote the investigators, led by Carsten Hjorthøj, PhD, MSc, Copenhagen Research Center for Mental Health, Denmark.
The study was published online Feb. 12 in the American Journal of Psychiatry.
Mechanism still poorly understood
Previous research suggests that infection increases the risk for schizophrenia, but this new study is the first to investigate the association between infection and substance-induced psychosis.
Using Danish national registry data, the researchers analyzed data on all individuals born in Denmark since 1981.
Any infection increased the risk for substance-induced psychosis in the fully-adjusted model (hazard ratio = 1.30; 95% confidence interval, 1.22–1.39; P less than .001). The risk was doubled in the first 2 years following a severe infection and stayed elevated for more than 20 years.
Hepatitis was the infection most strongly associated with substance-induced psychosis (HR = 3.42; 95% CI, 2.47–4.74; P less than .001) and only hepatitis predicted conversion to schizophrenia after substance-induced psychosis (HR = 1.87; 95% CI, 1.07–3.26; P = .03).
These results, the investigators note, “mirror previous findings on the association between infections and schizophrenia, including previous observations that the link is particularly strong for hepatitis.”
They also point out that the biological mechanisms through which infections would increase the risk for psychosis, including substance-induced psychosis, remain poorly understood.
“If the exact mechanisms underlying the psychotogenic properties of infections or the immune response can be identified, this is likely to lead to improvements in treatment for psychotic disorders. A further hope is that it may even be possible to use this knowledge for primary prevention of psychosis,” the authors wrote.
Interpret with caution
Commenting on the study, Ole Köhler-Forsberg, MD, from the Psychosis Research Unit, Aarhus University Hospital, Denmark, said in an interview that the findings support a potential immunologic link to schizophrenia.
“However,” he added, “as in every register-based study, no causality can be assumed, only associations. As mentioned by the authors, there may be residual confounding and confounding by indication.”
Also commenting on the study, René Kahn, MD, PhD, professor and chair of psychiatry at the Icahn School of Medicine at Mount Sinai in New York, noted in an interview that there is a lot of “indirect evidence” from epidemiologic studies like this one to suggest an immune component to psychosis.
“However, there is not a single piece of direct evidence linking the immune system to schizophrenia so far,” Dr. Kahn cautioned.
“Yes, people who have hepatitis have a higher risk of developing substance-induced psychosis, but this may be a spurious finding. It may very well be that people who are prone to hepatitis for whatever reasons are at higher risk for psychosis but there is no direct evidence that the two are related. This study doesn’t convince me at all that immune pathology is related to schizophrenia,” Dr. Kahn said.
The study was supported by a grant from the Lundbeck Foundation Initiative for Integrative Psychiatric Research (iPSYCH). The study authors, Dr. Kahn, and Dr. Köhler-Forsberg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.