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Stock inhalers at school effectively meet students’ rescue medication needs
DALLAS – Allowing public and private schools to store multiuse stock albuterol inhalers for students with asthma is a legally and medically feasible way to provide students with rescue medication without their need to leave school, according to a recent study.
“Stakeholder coalitions can facilitate the large-scale adoption of stock inhaler programs in schools,” concluded Ashley A. Lowe, MSPH, a senior research specialist and PhD candidate at the University of Arizona, Tucson, and colleagues in a poster at the American Thoracic Society’s international conference.“These programs improve access to rescue medication while returning students back to their classroom.”
The Arizona legislature passed H.B. 2208, “Stock Inhalers for Schools” in March 2017 to allow schools to store and administer albuterol sulfate while indemnifying trained staff against liability when they allowed students to use the inhaler in good faith. A stock inhaler can used by different students because of its disposable valved-holding chambers.
“Such laws allow schools to overcome the legal obstacles that make it difficult for them to ensure such medication is readily available to all children experiencing respiratory distress,” the authors wrote. They assessed the use and outcomes of schools’ storage of stock inhalers during the 2017-2018 school year in Pima County, Arizona.
Of the 213 public, 90 charter, and 61 private/parochial schools in Pima County, 246 (67%) total schools participated, including nearly all of the public schools (93%), nearly half the private/parochial schools (49%), and 17% of the charter schools. A total of 134,251 students had access to a stock inhaler at school.
Each participating school received a kit containing a 60-dose albuterol sulfate inhaler, 10 valved-holding chambers, a signed standing medical order, a standardized emergency protocol for albuterol use, access to an online training curriculum and template resources, along with technical support.
Each time a school used the stock inhaler, they documented whether an asthma diagnosis was known or not, total puffs administered and where the student went next – returned to class, sent home with caregiver, 911 call without transport, or 911 call with EMS transport.
Based on data analyzed from 240 schools, the stock inhalers were used 1,032 times at 152 schools during the study period, predominantly at public schools (97%) and by students with a known asthma diagnosis (82%). In 12.2% of cases, the student did not have a known asthma diagnosis, and 5.8% of the time, asthma diagnosis status was unknown. The students received a mean 2.7 puffs at each use.
Ethnicity and race data of those students who used the inhalers was not complete. Most of the students for whom ethnicity data were available (n = 343) and who used the inhaler were Hispanic/Latino (69.8%) independent of race. Based only on the 437 students for whom data on race were available, students using the inhaler included 41% white, 11.7% black, 3.1% Native American/Alaskan Native, 1% Asian and 0.6% Native Hawaiian/Pacific Islander.
Among the 915 uses of the inhaler for which subsequent student location was available, the majority of students (84%) returned to their classroom after using the inhaler. Only five were transported to a medical facility via EMS following a 911 call, and 911 was called for one student who did not receive EMS transport.
According to the Allergy & Asthma Network, the following states have school stock albuterol laws: Arizona, Colorado, Georgia, Illinois, Missouri, New Hampshire, New Mexico, Oklahoma, Ohio, Texas, Utah, and West Virginia.*
The research was funded by Banner–University Medical Center Tucson, Thayer Medical Corporation, and the Asthma & Airway Disease Research Center. The authors had no disclosures.
SOURCE: Lowe AA et al. ATS 2019, Abstract A4070.
* This article was updated on July 15, 2019.
DALLAS – Allowing public and private schools to store multiuse stock albuterol inhalers for students with asthma is a legally and medically feasible way to provide students with rescue medication without their need to leave school, according to a recent study.
“Stakeholder coalitions can facilitate the large-scale adoption of stock inhaler programs in schools,” concluded Ashley A. Lowe, MSPH, a senior research specialist and PhD candidate at the University of Arizona, Tucson, and colleagues in a poster at the American Thoracic Society’s international conference.“These programs improve access to rescue medication while returning students back to their classroom.”
The Arizona legislature passed H.B. 2208, “Stock Inhalers for Schools” in March 2017 to allow schools to store and administer albuterol sulfate while indemnifying trained staff against liability when they allowed students to use the inhaler in good faith. A stock inhaler can used by different students because of its disposable valved-holding chambers.
“Such laws allow schools to overcome the legal obstacles that make it difficult for them to ensure such medication is readily available to all children experiencing respiratory distress,” the authors wrote. They assessed the use and outcomes of schools’ storage of stock inhalers during the 2017-2018 school year in Pima County, Arizona.
Of the 213 public, 90 charter, and 61 private/parochial schools in Pima County, 246 (67%) total schools participated, including nearly all of the public schools (93%), nearly half the private/parochial schools (49%), and 17% of the charter schools. A total of 134,251 students had access to a stock inhaler at school.
Each participating school received a kit containing a 60-dose albuterol sulfate inhaler, 10 valved-holding chambers, a signed standing medical order, a standardized emergency protocol for albuterol use, access to an online training curriculum and template resources, along with technical support.
Each time a school used the stock inhaler, they documented whether an asthma diagnosis was known or not, total puffs administered and where the student went next – returned to class, sent home with caregiver, 911 call without transport, or 911 call with EMS transport.
Based on data analyzed from 240 schools, the stock inhalers were used 1,032 times at 152 schools during the study period, predominantly at public schools (97%) and by students with a known asthma diagnosis (82%). In 12.2% of cases, the student did not have a known asthma diagnosis, and 5.8% of the time, asthma diagnosis status was unknown. The students received a mean 2.7 puffs at each use.
Ethnicity and race data of those students who used the inhalers was not complete. Most of the students for whom ethnicity data were available (n = 343) and who used the inhaler were Hispanic/Latino (69.8%) independent of race. Based only on the 437 students for whom data on race were available, students using the inhaler included 41% white, 11.7% black, 3.1% Native American/Alaskan Native, 1% Asian and 0.6% Native Hawaiian/Pacific Islander.
Among the 915 uses of the inhaler for which subsequent student location was available, the majority of students (84%) returned to their classroom after using the inhaler. Only five were transported to a medical facility via EMS following a 911 call, and 911 was called for one student who did not receive EMS transport.
According to the Allergy & Asthma Network, the following states have school stock albuterol laws: Arizona, Colorado, Georgia, Illinois, Missouri, New Hampshire, New Mexico, Oklahoma, Ohio, Texas, Utah, and West Virginia.*
The research was funded by Banner–University Medical Center Tucson, Thayer Medical Corporation, and the Asthma & Airway Disease Research Center. The authors had no disclosures.
SOURCE: Lowe AA et al. ATS 2019, Abstract A4070.
* This article was updated on July 15, 2019.
DALLAS – Allowing public and private schools to store multiuse stock albuterol inhalers for students with asthma is a legally and medically feasible way to provide students with rescue medication without their need to leave school, according to a recent study.
“Stakeholder coalitions can facilitate the large-scale adoption of stock inhaler programs in schools,” concluded Ashley A. Lowe, MSPH, a senior research specialist and PhD candidate at the University of Arizona, Tucson, and colleagues in a poster at the American Thoracic Society’s international conference.“These programs improve access to rescue medication while returning students back to their classroom.”
The Arizona legislature passed H.B. 2208, “Stock Inhalers for Schools” in March 2017 to allow schools to store and administer albuterol sulfate while indemnifying trained staff against liability when they allowed students to use the inhaler in good faith. A stock inhaler can used by different students because of its disposable valved-holding chambers.
“Such laws allow schools to overcome the legal obstacles that make it difficult for them to ensure such medication is readily available to all children experiencing respiratory distress,” the authors wrote. They assessed the use and outcomes of schools’ storage of stock inhalers during the 2017-2018 school year in Pima County, Arizona.
Of the 213 public, 90 charter, and 61 private/parochial schools in Pima County, 246 (67%) total schools participated, including nearly all of the public schools (93%), nearly half the private/parochial schools (49%), and 17% of the charter schools. A total of 134,251 students had access to a stock inhaler at school.
Each participating school received a kit containing a 60-dose albuterol sulfate inhaler, 10 valved-holding chambers, a signed standing medical order, a standardized emergency protocol for albuterol use, access to an online training curriculum and template resources, along with technical support.
Each time a school used the stock inhaler, they documented whether an asthma diagnosis was known or not, total puffs administered and where the student went next – returned to class, sent home with caregiver, 911 call without transport, or 911 call with EMS transport.
Based on data analyzed from 240 schools, the stock inhalers were used 1,032 times at 152 schools during the study period, predominantly at public schools (97%) and by students with a known asthma diagnosis (82%). In 12.2% of cases, the student did not have a known asthma diagnosis, and 5.8% of the time, asthma diagnosis status was unknown. The students received a mean 2.7 puffs at each use.
Ethnicity and race data of those students who used the inhalers was not complete. Most of the students for whom ethnicity data were available (n = 343) and who used the inhaler were Hispanic/Latino (69.8%) independent of race. Based only on the 437 students for whom data on race were available, students using the inhaler included 41% white, 11.7% black, 3.1% Native American/Alaskan Native, 1% Asian and 0.6% Native Hawaiian/Pacific Islander.
Among the 915 uses of the inhaler for which subsequent student location was available, the majority of students (84%) returned to their classroom after using the inhaler. Only five were transported to a medical facility via EMS following a 911 call, and 911 was called for one student who did not receive EMS transport.
According to the Allergy & Asthma Network, the following states have school stock albuterol laws: Arizona, Colorado, Georgia, Illinois, Missouri, New Hampshire, New Mexico, Oklahoma, Ohio, Texas, Utah, and West Virginia.*
The research was funded by Banner–University Medical Center Tucson, Thayer Medical Corporation, and the Asthma & Airway Disease Research Center. The authors had no disclosures.
SOURCE: Lowe AA et al. ATS 2019, Abstract A4070.
* This article was updated on July 15, 2019.
REPORTING FROM ATS 2019
Mental illness in MS: ‘Follow the why’
SEATTLE – , a neuropsychiatrist cautioned colleagues who treat MS.
For example, depression may strike a patient as a primary condition, just as it could in anyone. But it may also be a manifestation of MS itself, or a side effect of an MS medication, or spurred by the fatigue and pain caused by MS, said Laura T. Safar, MD, a psychiatrist affiliated with Brigham and Women's Hospital, Boston*. As a result, popular psychiatric treatments such as SSRIs might not necessarily be the best approach, said Dr. Safar, who spoke in an interview and during a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“You need to follow the why,” she said in the interview, adding that it is crucial to view neurologic and mental health as one and the same in MS. “More integration,” she said, “continues to be the way to go.”
Here are some pearls and tips from Dr. Safar’s presentation on treating psychiatric conditions in patients with MS:
Mental illness incidence
Depression is estimated to affect 25%-45% of people with MS over their lifetimes, while bipolar disorder is thought to affect 6% of patients and a quarter are estimated to have anxiety.
Researchers also believe as many as 10% of patients are affected by pathological laughing and crying during their lives.
Psychiatric side effects
Interferon drugs are notoriously linked to depression and psychosis. Glatiramer acetate (Copaxone) and natalizumab (Tysabri) are also thought to cause psychiatric side effects in some cases – anxiety and depression, respectively. But drug-modifying therapies can also provide relief on the psychiatric front, Dr. Safar said.
Meanwhile, dozens of other drugs used to treat aspects of MS such as spasticity, pain, and fatigue have possible psychiatric side effects.
Alternatives to SSRIs
SSRIs are often a first option in psychiatric patients, but those with MS may need another option because so many – an estimated 80% – also have fatigue, Dr. Safar said.
Alternatives for patients with MS include serotonin and norepinephrine reuptake inhibitors (SNRIs), which may have an advantage over SSRIs, she said. Specifically, SNRIs and bupropion (Wellbutrin) may be better for patients with fatigue and cognitive problems, she said, while vortioxetine (Trintellix) may benefit cognition.
Treating anxiety
There are no data regarding the best drug treatment for anxiety in patients with MS, she said, and SSRIs are typically the starting point. Consider SNRIs and duloxetine, respectively, when patients also have significant fatigue and cognitive symptoms. Use benzodiazepines only in occasional cases (such as anxiety regarding an MRI) and severe cases, she said.
MS-specific side effects
Beware of MS-specific side effects, Dr. Safar said. Some common psychiatric drugs, especially citalopram (Celexa) and escitalopram (Lexapro), may increase the QTc interval and shouldn’t be used in combination with the MS drug fingolimod (Gilenya).
And, she said, bupropion is “a very helpful agent” but poses a rare risk of seizures. Dr. Safar said she has seen this side effect a couple times over 10 years, but both were in patients with “other factors involved.” Still, “it’s something to keep in mind.”
Also understand that serotonergic agents can worsen restless legs syndrome, which is more common in patients with MS. Dr. Safar advises monitoring for the condition.
Pathological laughing, crying
Episodes of so-called pathological laughing, crying, or both tend to be brief, frequent, and intense. They may be sparked by nothing at all, and more often feature crying.
Certain SSRIs have proved helpful for the condition in MS, Dr. Safar said. Research also supports a combination of dextromethorphan (cough suppressant) and quinidine (a drug used to treat arrhythmias and malaria). The combination is sold together as Nuedexta.
Other agents such as venlafaxine (Effexor) and duloxetine (Cymbalta) have very limited data and shouldn’t be first-line treatment, she said.
Dr. Safar reports no relevant disclosures.
Correction, 5/31/19: An earlier version of this article misstated Dr. Safar's hospital affiliation.
SEATTLE – , a neuropsychiatrist cautioned colleagues who treat MS.
For example, depression may strike a patient as a primary condition, just as it could in anyone. But it may also be a manifestation of MS itself, or a side effect of an MS medication, or spurred by the fatigue and pain caused by MS, said Laura T. Safar, MD, a psychiatrist affiliated with Brigham and Women's Hospital, Boston*. As a result, popular psychiatric treatments such as SSRIs might not necessarily be the best approach, said Dr. Safar, who spoke in an interview and during a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“You need to follow the why,” she said in the interview, adding that it is crucial to view neurologic and mental health as one and the same in MS. “More integration,” she said, “continues to be the way to go.”
Here are some pearls and tips from Dr. Safar’s presentation on treating psychiatric conditions in patients with MS:
Mental illness incidence
Depression is estimated to affect 25%-45% of people with MS over their lifetimes, while bipolar disorder is thought to affect 6% of patients and a quarter are estimated to have anxiety.
Researchers also believe as many as 10% of patients are affected by pathological laughing and crying during their lives.
Psychiatric side effects
Interferon drugs are notoriously linked to depression and psychosis. Glatiramer acetate (Copaxone) and natalizumab (Tysabri) are also thought to cause psychiatric side effects in some cases – anxiety and depression, respectively. But drug-modifying therapies can also provide relief on the psychiatric front, Dr. Safar said.
Meanwhile, dozens of other drugs used to treat aspects of MS such as spasticity, pain, and fatigue have possible psychiatric side effects.
Alternatives to SSRIs
SSRIs are often a first option in psychiatric patients, but those with MS may need another option because so many – an estimated 80% – also have fatigue, Dr. Safar said.
Alternatives for patients with MS include serotonin and norepinephrine reuptake inhibitors (SNRIs), which may have an advantage over SSRIs, she said. Specifically, SNRIs and bupropion (Wellbutrin) may be better for patients with fatigue and cognitive problems, she said, while vortioxetine (Trintellix) may benefit cognition.
Treating anxiety
There are no data regarding the best drug treatment for anxiety in patients with MS, she said, and SSRIs are typically the starting point. Consider SNRIs and duloxetine, respectively, when patients also have significant fatigue and cognitive symptoms. Use benzodiazepines only in occasional cases (such as anxiety regarding an MRI) and severe cases, she said.
MS-specific side effects
Beware of MS-specific side effects, Dr. Safar said. Some common psychiatric drugs, especially citalopram (Celexa) and escitalopram (Lexapro), may increase the QTc interval and shouldn’t be used in combination with the MS drug fingolimod (Gilenya).
And, she said, bupropion is “a very helpful agent” but poses a rare risk of seizures. Dr. Safar said she has seen this side effect a couple times over 10 years, but both were in patients with “other factors involved.” Still, “it’s something to keep in mind.”
Also understand that serotonergic agents can worsen restless legs syndrome, which is more common in patients with MS. Dr. Safar advises monitoring for the condition.
Pathological laughing, crying
Episodes of so-called pathological laughing, crying, or both tend to be brief, frequent, and intense. They may be sparked by nothing at all, and more often feature crying.
Certain SSRIs have proved helpful for the condition in MS, Dr. Safar said. Research also supports a combination of dextromethorphan (cough suppressant) and quinidine (a drug used to treat arrhythmias and malaria). The combination is sold together as Nuedexta.
Other agents such as venlafaxine (Effexor) and duloxetine (Cymbalta) have very limited data and shouldn’t be first-line treatment, she said.
Dr. Safar reports no relevant disclosures.
Correction, 5/31/19: An earlier version of this article misstated Dr. Safar's hospital affiliation.
SEATTLE – , a neuropsychiatrist cautioned colleagues who treat MS.
For example, depression may strike a patient as a primary condition, just as it could in anyone. But it may also be a manifestation of MS itself, or a side effect of an MS medication, or spurred by the fatigue and pain caused by MS, said Laura T. Safar, MD, a psychiatrist affiliated with Brigham and Women's Hospital, Boston*. As a result, popular psychiatric treatments such as SSRIs might not necessarily be the best approach, said Dr. Safar, who spoke in an interview and during a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“You need to follow the why,” she said in the interview, adding that it is crucial to view neurologic and mental health as one and the same in MS. “More integration,” she said, “continues to be the way to go.”
Here are some pearls and tips from Dr. Safar’s presentation on treating psychiatric conditions in patients with MS:
Mental illness incidence
Depression is estimated to affect 25%-45% of people with MS over their lifetimes, while bipolar disorder is thought to affect 6% of patients and a quarter are estimated to have anxiety.
Researchers also believe as many as 10% of patients are affected by pathological laughing and crying during their lives.
Psychiatric side effects
Interferon drugs are notoriously linked to depression and psychosis. Glatiramer acetate (Copaxone) and natalizumab (Tysabri) are also thought to cause psychiatric side effects in some cases – anxiety and depression, respectively. But drug-modifying therapies can also provide relief on the psychiatric front, Dr. Safar said.
Meanwhile, dozens of other drugs used to treat aspects of MS such as spasticity, pain, and fatigue have possible psychiatric side effects.
Alternatives to SSRIs
SSRIs are often a first option in psychiatric patients, but those with MS may need another option because so many – an estimated 80% – also have fatigue, Dr. Safar said.
Alternatives for patients with MS include serotonin and norepinephrine reuptake inhibitors (SNRIs), which may have an advantage over SSRIs, she said. Specifically, SNRIs and bupropion (Wellbutrin) may be better for patients with fatigue and cognitive problems, she said, while vortioxetine (Trintellix) may benefit cognition.
Treating anxiety
There are no data regarding the best drug treatment for anxiety in patients with MS, she said, and SSRIs are typically the starting point. Consider SNRIs and duloxetine, respectively, when patients also have significant fatigue and cognitive symptoms. Use benzodiazepines only in occasional cases (such as anxiety regarding an MRI) and severe cases, she said.
MS-specific side effects
Beware of MS-specific side effects, Dr. Safar said. Some common psychiatric drugs, especially citalopram (Celexa) and escitalopram (Lexapro), may increase the QTc interval and shouldn’t be used in combination with the MS drug fingolimod (Gilenya).
And, she said, bupropion is “a very helpful agent” but poses a rare risk of seizures. Dr. Safar said she has seen this side effect a couple times over 10 years, but both were in patients with “other factors involved.” Still, “it’s something to keep in mind.”
Also understand that serotonergic agents can worsen restless legs syndrome, which is more common in patients with MS. Dr. Safar advises monitoring for the condition.
Pathological laughing, crying
Episodes of so-called pathological laughing, crying, or both tend to be brief, frequent, and intense. They may be sparked by nothing at all, and more often feature crying.
Certain SSRIs have proved helpful for the condition in MS, Dr. Safar said. Research also supports a combination of dextromethorphan (cough suppressant) and quinidine (a drug used to treat arrhythmias and malaria). The combination is sold together as Nuedexta.
Other agents such as venlafaxine (Effexor) and duloxetine (Cymbalta) have very limited data and shouldn’t be first-line treatment, she said.
Dr. Safar reports no relevant disclosures.
Correction, 5/31/19: An earlier version of this article misstated Dr. Safar's hospital affiliation.
EXPERT ANALYSIS FROM CMSC 2019
Low baseline heart rate may not increase cardiac risk when starting fingolimod
SEATTLE – , according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.
Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via the Gilenya@Home program.
To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.
The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.
Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.
About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.
“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.
Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.
SEATTLE – , according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.
Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via the Gilenya@Home program.
To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.
The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.
Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.
About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.
“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.
Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.
SEATTLE – , according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. In addition, the data “provide further evidence that first-dose cardiac events with fingolimod are rare,” regardless of whether the first dose is given in a clinic or a patient’s home, the study researchers said.
Transient heart rate decreases are an anticipated effect of starting fingolimod, and the U.S. prescribing information for the drug requires first-dose observation of heart rate and blood pressure for at least 6 hours. Heart rate and blood pressure may be monitored in a clinic or at home via the Gilenya@Home program.
To examine whether low baseline heart rate is associated with the likelihood of certain cardiac events during the first-dose observation period, John Osborne, MD, of State of the Heart Cardiology in Grapevine, Tex., and colleagues analyzed retrospective, first-dose observation data from Gilenya@Home between October 2014 and July 2017 and from Gilenya Assessment Network clinics between July 2010 and December 2016.
The investigators sought to determine whether baseline heart rate predicts the risk of documented bradycardia, new-onset second-degree atrioventricular block, or ED transfer for additional monitoring. In addition, they examined whether patients with heart rates above a certain threshold may be at risk of first-dose cardiac events.
Dr. Osborne and colleagues reviewed data from 5,572 in-home and 15,025 in-clinic first-dose observation procedures. They classified patients as having marked bradycardia (under 50 beats per minute), mild bradycardia (50-59 bpm), or a normal heart rate (at least 60 bpm) at baseline. During the 20,001 procedures with available data, 182 cardiac events occurred, including 28 instances of documented bradycardia, 13 instances of second-degree atrioventricular block, and 141 instances of ED transfer for extended monitoring; 40 events occurred during at-home monitoring, and 142 events occurred in clinic.
About 87.0% of the cardiac events occurred in patients with a normal baseline heart rate, 11.5% occurred in patients with mild bradycardia, and 1.1% occurred in patients with marked bradycardia. The two cardiac events in patients with marked bradycardia at baseline were ED transfers of patients whose first-dose observations occurred in clinics. “The threshold heart rate above which patients did not experience a cardiac event was 80 bpm, well within the normal range of 60-100 bpm,” the authors said.
“These data suggest that patients with a low baseline heart rate may be at no more risk of cardiac events than patients with a heart rate in the normal range, nor is there a baseline heart rate threshold below which a patient is at greater risk of cardiac events,” Dr. Osborne and colleagues concluded.
Dr. Osborne reporting receiving a consulting fee from Novartis, which markets Gilenya (fingolimod), and his coauthors are employees of Novartis.
REPORTING FROM CMSC 2019
Music shows promise for inpatient agitation
SAN FRANCISCO – In a proof-of-concept study, music provided an alternative to oral psychotropic medication in calming agitated patients at an inpatient psychiatric facility. Music has been studied as a treatment for agitation in dementia patients but not so much in psychiatric patients, according to Trevor Scudamore, MD, who is a resident fellow at State University of New York, Syracuse.
“The other thing is that music has been more looked at in group therapy settings than as adjunct therapy, or as an option as an as-needed medication for agitation,” Dr. Scudamore said in an interview. He presented the study at a poster session at the annual meeting of the American Psychiatric Association.
When agitation arose, the program allowed patients to choose between an oral medication or music, which entailed a 30-minute session listening to a preset playlist using a wireless headphone. Playlist options included a variety of musical genres, and participants could sit in one place or roam around while listening.
Traditionally, agitated patients had the choice of an oral medication. If the patient refused and then escalated, they had to accept an intravenous medication. “Now there’s a choice between an oral medication and music, almost like a third layer in defusing agitation in the patient. If they refuse music, then they could go for oral medication, and then [IV medication]. They’re given a little bit more options. Maybe they don’t feel so confined, which is an interesting way of helping possibly defuse anxiety from a situation. That needs to be explored further,” Dr. Scudamore said.
The study had a two-phase, cross-sectional design. The first 3 months, the study included 71 patients, who were used to establish a baseline of agitation and psychotropic medication use. They introduced the music intervention during the second 3-month period, with 101 participants. After they listened to music, the patients completed a self-report form using the Likert scale, and nursing staff observed the patients status during the initial anxiety/agitation, while they listened to music, and 15 minutes after the listening session.
That need for commitment from nurses presented a challenge to implementation. They had to hand out headphones, keep track of them, and make sure they got the headphones back. “It is a lot more work than just giving 50 mg of hydroxyzine,” said coauthor Christopher Botash, MD, who also is a resident at the university.
Study participants had a range of psychiatric ills, including substance abuse (61%), depression (51%), psychosis (28%), trauma (26%), personality disorder (20%), and anxiety (17%).
As part of a preliminary report, the researchers presented data from surveys completed by nine nurses and 31 patients. The two most commonly prescribed antipsychotics saw a decrease in administrations, from 3.37 to 2.93/month for haloperidol, and from 3.83 to 2.73 administrations/month for olanzapine.
A total of 56% of the nursing staff stated that the music therapy program helped calm down the patients. Nurses who disagreed cited the tendency for patients to intrude at the nursing station asking for the music, though this improved as patients learned the routine. Ninety-six percent of the patients reported satisfaction with the experience.
It was challenging for the researchers to implement the study, since offering music was a break in the routine. “The staff really does rely a lot on the meds, so oftentimes we would have to say, ‘Hey, have you offered the music yet?’ It’s a bit of a culture change,” Dr. Botash said.
The study, which Dr. Scudamore and Dr. Botash coauthored with Nekpen S. Ekure, MD, did not receive external funding. Dr. Scudamore and Dr. Botash had no relevant financial disclosures.
SAN FRANCISCO – In a proof-of-concept study, music provided an alternative to oral psychotropic medication in calming agitated patients at an inpatient psychiatric facility. Music has been studied as a treatment for agitation in dementia patients but not so much in psychiatric patients, according to Trevor Scudamore, MD, who is a resident fellow at State University of New York, Syracuse.
“The other thing is that music has been more looked at in group therapy settings than as adjunct therapy, or as an option as an as-needed medication for agitation,” Dr. Scudamore said in an interview. He presented the study at a poster session at the annual meeting of the American Psychiatric Association.
When agitation arose, the program allowed patients to choose between an oral medication or music, which entailed a 30-minute session listening to a preset playlist using a wireless headphone. Playlist options included a variety of musical genres, and participants could sit in one place or roam around while listening.
Traditionally, agitated patients had the choice of an oral medication. If the patient refused and then escalated, they had to accept an intravenous medication. “Now there’s a choice between an oral medication and music, almost like a third layer in defusing agitation in the patient. If they refuse music, then they could go for oral medication, and then [IV medication]. They’re given a little bit more options. Maybe they don’t feel so confined, which is an interesting way of helping possibly defuse anxiety from a situation. That needs to be explored further,” Dr. Scudamore said.
The study had a two-phase, cross-sectional design. The first 3 months, the study included 71 patients, who were used to establish a baseline of agitation and psychotropic medication use. They introduced the music intervention during the second 3-month period, with 101 participants. After they listened to music, the patients completed a self-report form using the Likert scale, and nursing staff observed the patients status during the initial anxiety/agitation, while they listened to music, and 15 minutes after the listening session.
That need for commitment from nurses presented a challenge to implementation. They had to hand out headphones, keep track of them, and make sure they got the headphones back. “It is a lot more work than just giving 50 mg of hydroxyzine,” said coauthor Christopher Botash, MD, who also is a resident at the university.
Study participants had a range of psychiatric ills, including substance abuse (61%), depression (51%), psychosis (28%), trauma (26%), personality disorder (20%), and anxiety (17%).
As part of a preliminary report, the researchers presented data from surveys completed by nine nurses and 31 patients. The two most commonly prescribed antipsychotics saw a decrease in administrations, from 3.37 to 2.93/month for haloperidol, and from 3.83 to 2.73 administrations/month for olanzapine.
A total of 56% of the nursing staff stated that the music therapy program helped calm down the patients. Nurses who disagreed cited the tendency for patients to intrude at the nursing station asking for the music, though this improved as patients learned the routine. Ninety-six percent of the patients reported satisfaction with the experience.
It was challenging for the researchers to implement the study, since offering music was a break in the routine. “The staff really does rely a lot on the meds, so oftentimes we would have to say, ‘Hey, have you offered the music yet?’ It’s a bit of a culture change,” Dr. Botash said.
The study, which Dr. Scudamore and Dr. Botash coauthored with Nekpen S. Ekure, MD, did not receive external funding. Dr. Scudamore and Dr. Botash had no relevant financial disclosures.
SAN FRANCISCO – In a proof-of-concept study, music provided an alternative to oral psychotropic medication in calming agitated patients at an inpatient psychiatric facility. Music has been studied as a treatment for agitation in dementia patients but not so much in psychiatric patients, according to Trevor Scudamore, MD, who is a resident fellow at State University of New York, Syracuse.
“The other thing is that music has been more looked at in group therapy settings than as adjunct therapy, or as an option as an as-needed medication for agitation,” Dr. Scudamore said in an interview. He presented the study at a poster session at the annual meeting of the American Psychiatric Association.
When agitation arose, the program allowed patients to choose between an oral medication or music, which entailed a 30-minute session listening to a preset playlist using a wireless headphone. Playlist options included a variety of musical genres, and participants could sit in one place or roam around while listening.
Traditionally, agitated patients had the choice of an oral medication. If the patient refused and then escalated, they had to accept an intravenous medication. “Now there’s a choice between an oral medication and music, almost like a third layer in defusing agitation in the patient. If they refuse music, then they could go for oral medication, and then [IV medication]. They’re given a little bit more options. Maybe they don’t feel so confined, which is an interesting way of helping possibly defuse anxiety from a situation. That needs to be explored further,” Dr. Scudamore said.
The study had a two-phase, cross-sectional design. The first 3 months, the study included 71 patients, who were used to establish a baseline of agitation and psychotropic medication use. They introduced the music intervention during the second 3-month period, with 101 participants. After they listened to music, the patients completed a self-report form using the Likert scale, and nursing staff observed the patients status during the initial anxiety/agitation, while they listened to music, and 15 minutes after the listening session.
That need for commitment from nurses presented a challenge to implementation. They had to hand out headphones, keep track of them, and make sure they got the headphones back. “It is a lot more work than just giving 50 mg of hydroxyzine,” said coauthor Christopher Botash, MD, who also is a resident at the university.
Study participants had a range of psychiatric ills, including substance abuse (61%), depression (51%), psychosis (28%), trauma (26%), personality disorder (20%), and anxiety (17%).
As part of a preliminary report, the researchers presented data from surveys completed by nine nurses and 31 patients. The two most commonly prescribed antipsychotics saw a decrease in administrations, from 3.37 to 2.93/month for haloperidol, and from 3.83 to 2.73 administrations/month for olanzapine.
A total of 56% of the nursing staff stated that the music therapy program helped calm down the patients. Nurses who disagreed cited the tendency for patients to intrude at the nursing station asking for the music, though this improved as patients learned the routine. Ninety-six percent of the patients reported satisfaction with the experience.
It was challenging for the researchers to implement the study, since offering music was a break in the routine. “The staff really does rely a lot on the meds, so oftentimes we would have to say, ‘Hey, have you offered the music yet?’ It’s a bit of a culture change,” Dr. Botash said.
The study, which Dr. Scudamore and Dr. Botash coauthored with Nekpen S. Ekure, MD, did not receive external funding. Dr. Scudamore and Dr. Botash had no relevant financial disclosures.
REPORTING FROM APA 2019
Questions remain as marijuana enters clinic use
SAN FRANCISCO – Medical marijuana skipped the usual phased testing of pharmaceuticals, so questions abound about how to counsel patients as legalization rolls out across the country, speakers said at the American Psychiatric Association annual meeting.
Drug interactions are an issue but remain under the radar. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are inhibitors of cytochrome P450, specifically the CYP2C enzyme and CYP3A liver enzymes, which means possible interactions with drug classes such as antidepressants and antipsychotics might come into play.
Concomitant use could affect, or be affected by, fluoxetine, clozapine, duloxetine, and olanzapine, among other medications. One case study suggested that warfarin doses should be reduced by 30% in a patient who had started with a liquid formulation of CBD for managing epilepsy (Basic Clin Pharmacol Toxicol. 2019 Jan;124[1]:28-31).
At this point, it’s “not clear what the clinic implications are,” but “it’s not unreasonable to consider that your patients’ response to their psychiatric medications might change based on the introduction of cannabinoids,” said Arthur Williams, MD, assistant professor of clinical psychiatry at Columbia University, New York, and one of many researchers playing catch-up as marijuana and its derivatives enter the clinic.
Another question is what, exactly, is a standard dose?
Dosing mostly has been a question of THC, the psychoactive component of marijuana. Washington state and Colorado opted for 10-mg THC when those jurisdictions legalized recreational use; Oregon chose 5 mg. Both are in line with Food and Drug Administration formulations already on the market, including dronabinol (Marinol), a synthetic THC approved in 2.5-mg, 5-mg, and 10-mg doses for AIDS wasting, and chemotherapy nausea and vomiting.
A typical .7-g joint of 8% THC delivers about 5 mg or so, but newer strains range up to 20% THC, and could deliver over 13 mg per joint; occasional users, meanwhile, feel high from just 2-3 mg.
The ratio of THC to CBD matters, as well. Generally, “whole plant marijuana on the black market is much higher in THC and much lower in CBD,” Dr. Williams said. CBD is thought to deliver most of the medical benefits of marijuana.
It’s best to ask people what they’re using, and to counsel new users – especially the elderly – to start low and go slow. But keep in mind that many medical users have years of recreational use and have built up tolerance, he said.
Vaping is not a bad idea for those interested. It heats the plant material to high enough temperatures to release cannabinoids but without combusting. It’s a much more efficient THC delivery system than smoking, and there’s no smoke in the lungs. Vape patients often feel they can titrate their dose exactly.
Edibles are another matter. It can take hours for them to hit. Although THC levels do not spike with edibles as they do when the substance is inhaled, the effects last longer. A lot depends on how much food is in the gut.
The risk with edibles is that people may keep popping gummy bears and brownies because they don’t feel anything but end up overdosing. Children might be tempted by the treats, too, and for those under 4 years old, overdose can lead to fatal encephalopathic comas, “something we never really saw until edibles came around,” Dr. Williams said.
With edibles, “you have no idea what’s actually in the product.” Labels can be “inaccurate by an order of magnitude. Patients should be cautioned about that,” he said.
Pregnant and breastfeeding women, especially, should be warned away from marijuana. Some of the literature suggests a link between exposure to marijuana and preterm birth – in addition to early psychosis in vulnerable children.
Dr. Williams had no relevant disclosures.
SAN FRANCISCO – Medical marijuana skipped the usual phased testing of pharmaceuticals, so questions abound about how to counsel patients as legalization rolls out across the country, speakers said at the American Psychiatric Association annual meeting.
Drug interactions are an issue but remain under the radar. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are inhibitors of cytochrome P450, specifically the CYP2C enzyme and CYP3A liver enzymes, which means possible interactions with drug classes such as antidepressants and antipsychotics might come into play.
Concomitant use could affect, or be affected by, fluoxetine, clozapine, duloxetine, and olanzapine, among other medications. One case study suggested that warfarin doses should be reduced by 30% in a patient who had started with a liquid formulation of CBD for managing epilepsy (Basic Clin Pharmacol Toxicol. 2019 Jan;124[1]:28-31).
At this point, it’s “not clear what the clinic implications are,” but “it’s not unreasonable to consider that your patients’ response to their psychiatric medications might change based on the introduction of cannabinoids,” said Arthur Williams, MD, assistant professor of clinical psychiatry at Columbia University, New York, and one of many researchers playing catch-up as marijuana and its derivatives enter the clinic.
Another question is what, exactly, is a standard dose?
Dosing mostly has been a question of THC, the psychoactive component of marijuana. Washington state and Colorado opted for 10-mg THC when those jurisdictions legalized recreational use; Oregon chose 5 mg. Both are in line with Food and Drug Administration formulations already on the market, including dronabinol (Marinol), a synthetic THC approved in 2.5-mg, 5-mg, and 10-mg doses for AIDS wasting, and chemotherapy nausea and vomiting.
A typical .7-g joint of 8% THC delivers about 5 mg or so, but newer strains range up to 20% THC, and could deliver over 13 mg per joint; occasional users, meanwhile, feel high from just 2-3 mg.
The ratio of THC to CBD matters, as well. Generally, “whole plant marijuana on the black market is much higher in THC and much lower in CBD,” Dr. Williams said. CBD is thought to deliver most of the medical benefits of marijuana.
It’s best to ask people what they’re using, and to counsel new users – especially the elderly – to start low and go slow. But keep in mind that many medical users have years of recreational use and have built up tolerance, he said.
Vaping is not a bad idea for those interested. It heats the plant material to high enough temperatures to release cannabinoids but without combusting. It’s a much more efficient THC delivery system than smoking, and there’s no smoke in the lungs. Vape patients often feel they can titrate their dose exactly.
Edibles are another matter. It can take hours for them to hit. Although THC levels do not spike with edibles as they do when the substance is inhaled, the effects last longer. A lot depends on how much food is in the gut.
The risk with edibles is that people may keep popping gummy bears and brownies because they don’t feel anything but end up overdosing. Children might be tempted by the treats, too, and for those under 4 years old, overdose can lead to fatal encephalopathic comas, “something we never really saw until edibles came around,” Dr. Williams said.
With edibles, “you have no idea what’s actually in the product.” Labels can be “inaccurate by an order of magnitude. Patients should be cautioned about that,” he said.
Pregnant and breastfeeding women, especially, should be warned away from marijuana. Some of the literature suggests a link between exposure to marijuana and preterm birth – in addition to early psychosis in vulnerable children.
Dr. Williams had no relevant disclosures.
SAN FRANCISCO – Medical marijuana skipped the usual phased testing of pharmaceuticals, so questions abound about how to counsel patients as legalization rolls out across the country, speakers said at the American Psychiatric Association annual meeting.
Drug interactions are an issue but remain under the radar. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are inhibitors of cytochrome P450, specifically the CYP2C enzyme and CYP3A liver enzymes, which means possible interactions with drug classes such as antidepressants and antipsychotics might come into play.
Concomitant use could affect, or be affected by, fluoxetine, clozapine, duloxetine, and olanzapine, among other medications. One case study suggested that warfarin doses should be reduced by 30% in a patient who had started with a liquid formulation of CBD for managing epilepsy (Basic Clin Pharmacol Toxicol. 2019 Jan;124[1]:28-31).
At this point, it’s “not clear what the clinic implications are,” but “it’s not unreasonable to consider that your patients’ response to their psychiatric medications might change based on the introduction of cannabinoids,” said Arthur Williams, MD, assistant professor of clinical psychiatry at Columbia University, New York, and one of many researchers playing catch-up as marijuana and its derivatives enter the clinic.
Another question is what, exactly, is a standard dose?
Dosing mostly has been a question of THC, the psychoactive component of marijuana. Washington state and Colorado opted for 10-mg THC when those jurisdictions legalized recreational use; Oregon chose 5 mg. Both are in line with Food and Drug Administration formulations already on the market, including dronabinol (Marinol), a synthetic THC approved in 2.5-mg, 5-mg, and 10-mg doses for AIDS wasting, and chemotherapy nausea and vomiting.
A typical .7-g joint of 8% THC delivers about 5 mg or so, but newer strains range up to 20% THC, and could deliver over 13 mg per joint; occasional users, meanwhile, feel high from just 2-3 mg.
The ratio of THC to CBD matters, as well. Generally, “whole plant marijuana on the black market is much higher in THC and much lower in CBD,” Dr. Williams said. CBD is thought to deliver most of the medical benefits of marijuana.
It’s best to ask people what they’re using, and to counsel new users – especially the elderly – to start low and go slow. But keep in mind that many medical users have years of recreational use and have built up tolerance, he said.
Vaping is not a bad idea for those interested. It heats the plant material to high enough temperatures to release cannabinoids but without combusting. It’s a much more efficient THC delivery system than smoking, and there’s no smoke in the lungs. Vape patients often feel they can titrate their dose exactly.
Edibles are another matter. It can take hours for them to hit. Although THC levels do not spike with edibles as they do when the substance is inhaled, the effects last longer. A lot depends on how much food is in the gut.
The risk with edibles is that people may keep popping gummy bears and brownies because they don’t feel anything but end up overdosing. Children might be tempted by the treats, too, and for those under 4 years old, overdose can lead to fatal encephalopathic comas, “something we never really saw until edibles came around,” Dr. Williams said.
With edibles, “you have no idea what’s actually in the product.” Labels can be “inaccurate by an order of magnitude. Patients should be cautioned about that,” he said.
Pregnant and breastfeeding women, especially, should be warned away from marijuana. Some of the literature suggests a link between exposure to marijuana and preterm birth – in addition to early psychosis in vulnerable children.
Dr. Williams had no relevant disclosures.
REPORTING FROM APA 2019
Group creates three-step algorithm for the management of MS relapse
SEATTLE –
“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”
To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.
The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.
“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”
Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.
The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.
If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.
The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
SEATTLE –
“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”
To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.
The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.
“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”
Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.
The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.
If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.
The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
SEATTLE –
“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”
To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.
The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.
“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”
Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.
The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.
If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.
The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
REPORTING FROM CMSC 2019
Legal duty to nonpatients: Communicable diseases
Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?
A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”
B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.
C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.
D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.
E. All correct.
Answer: E. and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.1
Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,2 the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,3 a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.
A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,4 the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,5 a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.
Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”6 Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.
A recent case7 presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.
The AMA has filed an amicus brief in support of Dr. CC.8 It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”
References
1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).
2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).
3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).
4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).
5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).
6. California Health & Safety Code §121015 (a).
7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).
8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?
A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”
B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.
C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.
D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.
E. All correct.
Answer: E. and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.1
Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,2 the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,3 a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.
A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,4 the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,5 a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.
Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”6 Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.
A recent case7 presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.
The AMA has filed an amicus brief in support of Dr. CC.8 It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”
References
1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).
2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).
3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).
4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).
5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).
6. California Health & Safety Code §121015 (a).
7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).
8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?
A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”
B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.
C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.
D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.
E. All correct.
Answer: E. and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.1
Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,2 the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,3 a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.
A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,4 the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,5 a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.
Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”6 Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.
A recent case7 presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.
The AMA has filed an amicus brief in support of Dr. CC.8 It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”
References
1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).
2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).
3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).
4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).
5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).
6. California Health & Safety Code §121015 (a).
7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).
8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
Fingolimod reduces MS disease activity, compared with glatiramer acetate
SEATTLE – according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.
Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.
A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).
The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.
The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.
egreb@mdedge.com
SEATTLE – according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.
Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.
A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).
The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.
The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.
egreb@mdedge.com
SEATTLE – according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.
Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.
A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).
The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.
The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.
egreb@mdedge.com
REPORTING FROM CMSC 2019
Key clinical point: Fingolimod is superior to glatiramer acetate in reducing disease activity in relapsing remitting multiple sclerosis.
Major finding: The 0.5-mg/day dose of fingolimod reduced the annualized relapse rate by approximately 41%, compared with glatiramer acetate.
Study details: A randomized, phase 3 study of 859 patients with relapsing remitting multiple sclerosis.
Disclosures: The study had no sponsorship. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.
Hazardous cannabis use in MS linked to anxiety, depression
SEATTLE – A small new study suggests that although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.
For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.
The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.
Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.
They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).
The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.
The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.
No study funding was reported and the authors report no relevant disclosures.
SEATTLE – A small new study suggests that although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.
For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.
The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.
Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.
They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).
The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.
The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.
No study funding was reported and the authors report no relevant disclosures.
SEATTLE – A small new study suggests that although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.
For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.
The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.
Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.
They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).
The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.
The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.
No study funding was reported and the authors report no relevant disclosures.
REPORTING FROM CMSC 2019
Adherence to oral treatments for MS is poor
Seattle – , according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.
Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.
The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.
The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).
In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.
The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.
SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.
Seattle – , according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.
Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.
The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.
The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).
In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.
The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.
SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.
Seattle – , according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.
Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.
The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.
The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).
In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.
The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.
SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.
REPORTING FROM CMSC 2019