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Creating innovative discharge plans

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Thu, 04/04/2019 - 15:36

‘Long Stay Committee’ may help


Hospitalists pay attention to length of stay as a measure of hospital efficiency and resource utilization; outliers on that measure – “long stay patients” – who present complex discharges are a barrier to length of stay reduction. To address this challenge, one institution formed a multidisciplinary Long Stay Committee and described the results in an abstract.

The Long Stay Committee is composed of medical directors, the chief quality officer, directors in nursing, directors of case management/social work, hospitalists, risk management, finance, ethics, psychiatry, and directors of rehabilitation. The most complex patient discharges, identified by case management and social work, are brought to the Long Stay Committee.

“Lack of guardianship is one of the most encountered barriers,” according to the authors. “The Long Stay Committee played an integral part in our institution partnering with the local county to form a guardian service board which facilitates guardianship appointments. Other solutions have included working with the patient and support persons to find appropriate discharge levels of care throughout the United States and other countries as well as guiding them through the process to gain the necessary financial resources.”

The authors conclude that the foundation of the committee’s success in coming up with innovative discharge solutions is the broad range of disciplines that attend this committee and the atmosphere of teamwork it creates.

Reference

Heacock A et al. Long Stay Committee finds innovative discharge plans for difficult discharges. Hospital Medicine 2018, Abstract 312. .

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‘Long Stay Committee’ may help

‘Long Stay Committee’ may help


Hospitalists pay attention to length of stay as a measure of hospital efficiency and resource utilization; outliers on that measure – “long stay patients” – who present complex discharges are a barrier to length of stay reduction. To address this challenge, one institution formed a multidisciplinary Long Stay Committee and described the results in an abstract.

The Long Stay Committee is composed of medical directors, the chief quality officer, directors in nursing, directors of case management/social work, hospitalists, risk management, finance, ethics, psychiatry, and directors of rehabilitation. The most complex patient discharges, identified by case management and social work, are brought to the Long Stay Committee.

“Lack of guardianship is one of the most encountered barriers,” according to the authors. “The Long Stay Committee played an integral part in our institution partnering with the local county to form a guardian service board which facilitates guardianship appointments. Other solutions have included working with the patient and support persons to find appropriate discharge levels of care throughout the United States and other countries as well as guiding them through the process to gain the necessary financial resources.”

The authors conclude that the foundation of the committee’s success in coming up with innovative discharge solutions is the broad range of disciplines that attend this committee and the atmosphere of teamwork it creates.

Reference

Heacock A et al. Long Stay Committee finds innovative discharge plans for difficult discharges. Hospital Medicine 2018, Abstract 312. .


Hospitalists pay attention to length of stay as a measure of hospital efficiency and resource utilization; outliers on that measure – “long stay patients” – who present complex discharges are a barrier to length of stay reduction. To address this challenge, one institution formed a multidisciplinary Long Stay Committee and described the results in an abstract.

The Long Stay Committee is composed of medical directors, the chief quality officer, directors in nursing, directors of case management/social work, hospitalists, risk management, finance, ethics, psychiatry, and directors of rehabilitation. The most complex patient discharges, identified by case management and social work, are brought to the Long Stay Committee.

“Lack of guardianship is one of the most encountered barriers,” according to the authors. “The Long Stay Committee played an integral part in our institution partnering with the local county to form a guardian service board which facilitates guardianship appointments. Other solutions have included working with the patient and support persons to find appropriate discharge levels of care throughout the United States and other countries as well as guiding them through the process to gain the necessary financial resources.”

The authors conclude that the foundation of the committee’s success in coming up with innovative discharge solutions is the broad range of disciplines that attend this committee and the atmosphere of teamwork it creates.

Reference

Heacock A et al. Long Stay Committee finds innovative discharge plans for difficult discharges. Hospital Medicine 2018, Abstract 312. .

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‘Update in Hospital Medicine’ offered practice pearls at HM19

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Wed, 04/03/2019 - 16:55

Studies that question common practices

On the big stage at HM19 in late March, Carrie Herzke, MD, FAAP, FACP, SFHM, and Christopher Moriates, MD, FACP, SFHM, undertook the daunting task of summarizing a year’s worth of research relevant to the practice of hospital medicine – all within the span of an hour.

Dr. Carrie Herzke

As has been standard with the “Update in Hospital Medicine” session at previous SHM Annual Conferences, the presenters touched on lighter topics in the medical literature: a prospective cohort study that found drinking coffee was inversely associated with mortality, even for those who drink up to eight cups a day; a cross-sectional observational study in which patients noted that what a physician wears is an important consideration for them during care, with a white coat preferred over formal attire as the most highly rated preference in a clinical care setting; and a study from a pediatric journal in which researchers calculated the average transit time for a Lego figurine head ingested by an adult.

But Dr. Herzke and Dr. Moriates mainly covered more serious subjects. In an interview before the session, Dr. Herzke, associate vice chair for clinical affairs in the department of medicine at Johns Hopkins Medicine in Baltimore, said she and Dr. Moriates chose studies across the fields of infectious diseases, cardiology, and hematology that should make hospitalists question common practices and consider changing how they practice medicine at their home institution.

Dr. Moriates, assistant dean for health care value at the University of Texas at Austin, said in an interview that their topic choices reflected the breadth and diversity of patients taken care of by hospitalists.

Dr. Christopher Moriates

For example, he noted during the HM19 session that results from several studies suggest hospitalists may soon choose oral antibiotics over IV antibiotics for care of certain patient populations: the recent POET trial suggests use of oral antibiotics for patients with left-sided infective endocarditis resulted in a lower length of stay in hospital (19 inpatient days) when compared with use of IV antibiotics (3 inpatient days and 17 additional treatment days post discharge), while the OVIVA trial found a lower but noninferior treatment failure rate among patients who received oral antibiotics for bone and joint infection, compared with IV antibiotics. Although these were both well-done studies, Dr. Moriates and Dr. Herzke emphasized that the results challenge widely accepted standards of care, and it may not yet be time for a paradigm shift.

Direct oral anticoagulants (DOACs) also are being studied in patients with end-stage renal disease (ESRD) and cancer, Dr. Herzke said, and apixaban (Eliquis) 5 mg appears to be the preferred dose for a lower risk of stroke and mortality in patients with ESRD and atrial fibrillation. The speakers said there are further studies being developed for management of AF in patients with heart failure and DOACs for patients with ESRD.

Another retrospective cohort study from research in the Massachusetts Public Health Dataset found that buprenorphine may have a number needed to treat of 50 for opioid use disorder, which Dr. Moriates said is close in proximity for the number needed to treat for aspirin. “It seems like it’s time for this to become standard of care,” he said.

The speakers also highlighted common practices hospitalists should stop performing based on the latest evidence.

In one example, they revealed that there is conflicting research on angiotensin-converting enzyme (ACE) inhibitors. One study found transient preoperative interruption of ACE inhibitors was associated with a reduction in intraoperative hypotension during a noncardiac, nonvascular surgery. A second study linked ACE inhibitor use with a reduction in all-cause mortality. However, long-term use of ACE inhibitors also appears to be associated with a 14% increase in lung cancers, with an increased incidence based on longer use duration.

Hospitalists should also be aware of recommendations from a study on oxygen therapy, Dr. Herzke noted, which found that extra oxygen therapy may harm patients with MI or stroke; as a result, hospitalists should “wean oxygen as tolerated” in these patients. In addition, hospitalists also may want to consider using oral vancomycin (Vancocin) or fidaxomicin (Dificid) for treatment of Clostridium difficile infections, based on new evidence that found there is a higher cure rate for those treatments, compared with metronidazole.

Dr. Moriates and Dr. Herzke had no relevant financial conflicts.

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Studies that question common practices

Studies that question common practices

On the big stage at HM19 in late March, Carrie Herzke, MD, FAAP, FACP, SFHM, and Christopher Moriates, MD, FACP, SFHM, undertook the daunting task of summarizing a year’s worth of research relevant to the practice of hospital medicine – all within the span of an hour.

Dr. Carrie Herzke

As has been standard with the “Update in Hospital Medicine” session at previous SHM Annual Conferences, the presenters touched on lighter topics in the medical literature: a prospective cohort study that found drinking coffee was inversely associated with mortality, even for those who drink up to eight cups a day; a cross-sectional observational study in which patients noted that what a physician wears is an important consideration for them during care, with a white coat preferred over formal attire as the most highly rated preference in a clinical care setting; and a study from a pediatric journal in which researchers calculated the average transit time for a Lego figurine head ingested by an adult.

But Dr. Herzke and Dr. Moriates mainly covered more serious subjects. In an interview before the session, Dr. Herzke, associate vice chair for clinical affairs in the department of medicine at Johns Hopkins Medicine in Baltimore, said she and Dr. Moriates chose studies across the fields of infectious diseases, cardiology, and hematology that should make hospitalists question common practices and consider changing how they practice medicine at their home institution.

Dr. Moriates, assistant dean for health care value at the University of Texas at Austin, said in an interview that their topic choices reflected the breadth and diversity of patients taken care of by hospitalists.

Dr. Christopher Moriates

For example, he noted during the HM19 session that results from several studies suggest hospitalists may soon choose oral antibiotics over IV antibiotics for care of certain patient populations: the recent POET trial suggests use of oral antibiotics for patients with left-sided infective endocarditis resulted in a lower length of stay in hospital (19 inpatient days) when compared with use of IV antibiotics (3 inpatient days and 17 additional treatment days post discharge), while the OVIVA trial found a lower but noninferior treatment failure rate among patients who received oral antibiotics for bone and joint infection, compared with IV antibiotics. Although these were both well-done studies, Dr. Moriates and Dr. Herzke emphasized that the results challenge widely accepted standards of care, and it may not yet be time for a paradigm shift.

Direct oral anticoagulants (DOACs) also are being studied in patients with end-stage renal disease (ESRD) and cancer, Dr. Herzke said, and apixaban (Eliquis) 5 mg appears to be the preferred dose for a lower risk of stroke and mortality in patients with ESRD and atrial fibrillation. The speakers said there are further studies being developed for management of AF in patients with heart failure and DOACs for patients with ESRD.

Another retrospective cohort study from research in the Massachusetts Public Health Dataset found that buprenorphine may have a number needed to treat of 50 for opioid use disorder, which Dr. Moriates said is close in proximity for the number needed to treat for aspirin. “It seems like it’s time for this to become standard of care,” he said.

The speakers also highlighted common practices hospitalists should stop performing based on the latest evidence.

In one example, they revealed that there is conflicting research on angiotensin-converting enzyme (ACE) inhibitors. One study found transient preoperative interruption of ACE inhibitors was associated with a reduction in intraoperative hypotension during a noncardiac, nonvascular surgery. A second study linked ACE inhibitor use with a reduction in all-cause mortality. However, long-term use of ACE inhibitors also appears to be associated with a 14% increase in lung cancers, with an increased incidence based on longer use duration.

Hospitalists should also be aware of recommendations from a study on oxygen therapy, Dr. Herzke noted, which found that extra oxygen therapy may harm patients with MI or stroke; as a result, hospitalists should “wean oxygen as tolerated” in these patients. In addition, hospitalists also may want to consider using oral vancomycin (Vancocin) or fidaxomicin (Dificid) for treatment of Clostridium difficile infections, based on new evidence that found there is a higher cure rate for those treatments, compared with metronidazole.

Dr. Moriates and Dr. Herzke had no relevant financial conflicts.

On the big stage at HM19 in late March, Carrie Herzke, MD, FAAP, FACP, SFHM, and Christopher Moriates, MD, FACP, SFHM, undertook the daunting task of summarizing a year’s worth of research relevant to the practice of hospital medicine – all within the span of an hour.

Dr. Carrie Herzke

As has been standard with the “Update in Hospital Medicine” session at previous SHM Annual Conferences, the presenters touched on lighter topics in the medical literature: a prospective cohort study that found drinking coffee was inversely associated with mortality, even for those who drink up to eight cups a day; a cross-sectional observational study in which patients noted that what a physician wears is an important consideration for them during care, with a white coat preferred over formal attire as the most highly rated preference in a clinical care setting; and a study from a pediatric journal in which researchers calculated the average transit time for a Lego figurine head ingested by an adult.

But Dr. Herzke and Dr. Moriates mainly covered more serious subjects. In an interview before the session, Dr. Herzke, associate vice chair for clinical affairs in the department of medicine at Johns Hopkins Medicine in Baltimore, said she and Dr. Moriates chose studies across the fields of infectious diseases, cardiology, and hematology that should make hospitalists question common practices and consider changing how they practice medicine at their home institution.

Dr. Moriates, assistant dean for health care value at the University of Texas at Austin, said in an interview that their topic choices reflected the breadth and diversity of patients taken care of by hospitalists.

Dr. Christopher Moriates

For example, he noted during the HM19 session that results from several studies suggest hospitalists may soon choose oral antibiotics over IV antibiotics for care of certain patient populations: the recent POET trial suggests use of oral antibiotics for patients with left-sided infective endocarditis resulted in a lower length of stay in hospital (19 inpatient days) when compared with use of IV antibiotics (3 inpatient days and 17 additional treatment days post discharge), while the OVIVA trial found a lower but noninferior treatment failure rate among patients who received oral antibiotics for bone and joint infection, compared with IV antibiotics. Although these were both well-done studies, Dr. Moriates and Dr. Herzke emphasized that the results challenge widely accepted standards of care, and it may not yet be time for a paradigm shift.

Direct oral anticoagulants (DOACs) also are being studied in patients with end-stage renal disease (ESRD) and cancer, Dr. Herzke said, and apixaban (Eliquis) 5 mg appears to be the preferred dose for a lower risk of stroke and mortality in patients with ESRD and atrial fibrillation. The speakers said there are further studies being developed for management of AF in patients with heart failure and DOACs for patients with ESRD.

Another retrospective cohort study from research in the Massachusetts Public Health Dataset found that buprenorphine may have a number needed to treat of 50 for opioid use disorder, which Dr. Moriates said is close in proximity for the number needed to treat for aspirin. “It seems like it’s time for this to become standard of care,” he said.

The speakers also highlighted common practices hospitalists should stop performing based on the latest evidence.

In one example, they revealed that there is conflicting research on angiotensin-converting enzyme (ACE) inhibitors. One study found transient preoperative interruption of ACE inhibitors was associated with a reduction in intraoperative hypotension during a noncardiac, nonvascular surgery. A second study linked ACE inhibitor use with a reduction in all-cause mortality. However, long-term use of ACE inhibitors also appears to be associated with a 14% increase in lung cancers, with an increased incidence based on longer use duration.

Hospitalists should also be aware of recommendations from a study on oxygen therapy, Dr. Herzke noted, which found that extra oxygen therapy may harm patients with MI or stroke; as a result, hospitalists should “wean oxygen as tolerated” in these patients. In addition, hospitalists also may want to consider using oral vancomycin (Vancocin) or fidaxomicin (Dificid) for treatment of Clostridium difficile infections, based on new evidence that found there is a higher cure rate for those treatments, compared with metronidazole.

Dr. Moriates and Dr. Herzke had no relevant financial conflicts.

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30-day readmissions after STEMI with cardiogenic shock 13%

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Tue, 04/02/2019 - 14:39

Of patients with ST-elevation MI (STEMI) complicated by cardiogenic shock, 13% are readmitted within 30 days and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

Dr. Karan Sud

“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.

Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
 

“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.

In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.

Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.

The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.

“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.

“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.

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Of patients with ST-elevation MI (STEMI) complicated by cardiogenic shock, 13% are readmitted within 30 days and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

Dr. Karan Sud

“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.

Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
 

“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.

In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.

Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.

The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.

“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.

“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.

Of patients with ST-elevation MI (STEMI) complicated by cardiogenic shock, 13% are readmitted within 30 days and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

Dr. Karan Sud

“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.

Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
 

“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.

In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.

Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.

The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.

“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.

“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.

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REPORTING FROM CRT 2019

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More chest compression–only CPR leads to increased survival rates

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Tue, 04/09/2019 - 17:34

Both CPR rates and survival rates increased after chest compression–only CPR was introduced as an alternative for bystanders witnessing a cardiac arrest, according to a Swedish study of out-of-hospital cardiac arrests and subsequent CPR.

© American Heart Association, Inc.

“These findings support continuous endorsement of chest compression–only CPR as an option in future CPR guidelines because it is associated with higher CPR rates and survival in out-of-hospital cardiac arrests,” wrote Gabriel Riva, MD, of the Karolinska Institutet, Stockholm, and his coauthors. The study was published in Circulation.

To determine changes in the rate and type of CPR performed before emergency medical services (EMS) arrival, the researchers compared all bystander-witnessed out-of-hospital cardiac arrests (OHCAs) reported in Sweden between 2000 and 2017. In all, 30,445 patients were included; the time periods compared were 2000-2005, 2006-2010, and 2011-2017. Patients were categorized as receiving either no CPR (NO-CPR), standard CPR (S-CPR), or chest compression–only CPR (CO-CPR). In 2005, CO-CPR was introduced in national CPR guidelines as an option for bystanders; in 2010, it was recommended for anyone untrained in CPR.

The proportion of patients who received CPR in general increased from 41% in 2000-2005 to 59% in 2006-2010 to 68% in 2011-2017. S-CPR changed from 35% to 45% to 38% over the three periods, while CO-CPR increased from 5% to 14% to 30%. In regard to 30-day survival rates, the S-CPR group saw an increase from 9% to 13% to 16% and the CO-CPR group increased from 8% to 12% to 14%, compared with 4% to 6% to 7% for the NO-CPR group.

The authors noted the limitations of their study, including the results being based on register data and therefore subject to misclassification and missing data. In addition, missing data negated any reporting on the neurological function of survivors; analyzing witnessed OHCAs only also meant the findings could not be validated for nonwitnessed OHCA.

The Swedish Heart and Lung Foundation funded the study. The authors made no disclosures.

SOURCE: Riva G et al. Circulation. 2019 Apr 1. doi: 10.1161/CIRCULATIONAHA.118.038179.

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Both CPR rates and survival rates increased after chest compression–only CPR was introduced as an alternative for bystanders witnessing a cardiac arrest, according to a Swedish study of out-of-hospital cardiac arrests and subsequent CPR.

© American Heart Association, Inc.

“These findings support continuous endorsement of chest compression–only CPR as an option in future CPR guidelines because it is associated with higher CPR rates and survival in out-of-hospital cardiac arrests,” wrote Gabriel Riva, MD, of the Karolinska Institutet, Stockholm, and his coauthors. The study was published in Circulation.

To determine changes in the rate and type of CPR performed before emergency medical services (EMS) arrival, the researchers compared all bystander-witnessed out-of-hospital cardiac arrests (OHCAs) reported in Sweden between 2000 and 2017. In all, 30,445 patients were included; the time periods compared were 2000-2005, 2006-2010, and 2011-2017. Patients were categorized as receiving either no CPR (NO-CPR), standard CPR (S-CPR), or chest compression–only CPR (CO-CPR). In 2005, CO-CPR was introduced in national CPR guidelines as an option for bystanders; in 2010, it was recommended for anyone untrained in CPR.

The proportion of patients who received CPR in general increased from 41% in 2000-2005 to 59% in 2006-2010 to 68% in 2011-2017. S-CPR changed from 35% to 45% to 38% over the three periods, while CO-CPR increased from 5% to 14% to 30%. In regard to 30-day survival rates, the S-CPR group saw an increase from 9% to 13% to 16% and the CO-CPR group increased from 8% to 12% to 14%, compared with 4% to 6% to 7% for the NO-CPR group.

The authors noted the limitations of their study, including the results being based on register data and therefore subject to misclassification and missing data. In addition, missing data negated any reporting on the neurological function of survivors; analyzing witnessed OHCAs only also meant the findings could not be validated for nonwitnessed OHCA.

The Swedish Heart and Lung Foundation funded the study. The authors made no disclosures.

SOURCE: Riva G et al. Circulation. 2019 Apr 1. doi: 10.1161/CIRCULATIONAHA.118.038179.

Both CPR rates and survival rates increased after chest compression–only CPR was introduced as an alternative for bystanders witnessing a cardiac arrest, according to a Swedish study of out-of-hospital cardiac arrests and subsequent CPR.

© American Heart Association, Inc.

“These findings support continuous endorsement of chest compression–only CPR as an option in future CPR guidelines because it is associated with higher CPR rates and survival in out-of-hospital cardiac arrests,” wrote Gabriel Riva, MD, of the Karolinska Institutet, Stockholm, and his coauthors. The study was published in Circulation.

To determine changes in the rate and type of CPR performed before emergency medical services (EMS) arrival, the researchers compared all bystander-witnessed out-of-hospital cardiac arrests (OHCAs) reported in Sweden between 2000 and 2017. In all, 30,445 patients were included; the time periods compared were 2000-2005, 2006-2010, and 2011-2017. Patients were categorized as receiving either no CPR (NO-CPR), standard CPR (S-CPR), or chest compression–only CPR (CO-CPR). In 2005, CO-CPR was introduced in national CPR guidelines as an option for bystanders; in 2010, it was recommended for anyone untrained in CPR.

The proportion of patients who received CPR in general increased from 41% in 2000-2005 to 59% in 2006-2010 to 68% in 2011-2017. S-CPR changed from 35% to 45% to 38% over the three periods, while CO-CPR increased from 5% to 14% to 30%. In regard to 30-day survival rates, the S-CPR group saw an increase from 9% to 13% to 16% and the CO-CPR group increased from 8% to 12% to 14%, compared with 4% to 6% to 7% for the NO-CPR group.

The authors noted the limitations of their study, including the results being based on register data and therefore subject to misclassification and missing data. In addition, missing data negated any reporting on the neurological function of survivors; analyzing witnessed OHCAs only also meant the findings could not be validated for nonwitnessed OHCA.

The Swedish Heart and Lung Foundation funded the study. The authors made no disclosures.

SOURCE: Riva G et al. Circulation. 2019 Apr 1. doi: 10.1161/CIRCULATIONAHA.118.038179.

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Key clinical point: Since chest compression-only CPR was introduced and recommended as an alternative for bystanders witnessing a cardiac arrest, CPR rates and survival rates have increased.

Major finding: From 2001-2005 to 2011-2017, 30-day survival rates increased from 9% to 16% for the standard CPR group and from 8% to 14% for the chest compression–only group, compared with 4%-7% for the no CPR group.

Study details: An observational nationwide cohort study of 30,445 Swedish patients who suffered out-of-hospital cardiac arrest.

Disclosures: The Swedish Heart and Lung Foundation funded the study. The authors made no disclosures.

Source: Riva G et al. Circulation. 2019 Apr 1. doi: 10.1161/CIRCULATIONAHA.118.038179.

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Cellulitis pearls

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Fri, 03/29/2019 - 08:58

A 38-year-old man is admitted to the hospital with a painful, swollen left leg. This was not the first instance of this kind for him. He had been admitted for the same problem 3 months earlier. During the earlier admission, he was diagnosed with cellulitis and treated with intravenous cefazolin for 4 days, then discharged on cephalexin with resolution of his swelling and pain. Today, his blood pressure is 120/70, pulse is 90, temperature is 38.2°C, his left leg is edematous from the mid-calf to the ankle, and he has erythema and warmth over the calf. His white blood cell count is 13,000, and a diagnosis of cellulitis is made. Which of the following treatments is most likely to shorten his hospital stay?

Dr. Paauw


A. Vancomycin therapy instead of cefazolin.

B. Piperacillin/tazobactam therapy instead of cefazolin.

C. Prednisolone therapy in addition to antibiotics.

D. Furosemide therapy in addition to antibiotics.

The correct answer is C, prednisolone therapy in addition to antibiotics. Corticosteroids have been used as therapy for a number of infectious diseases, and steroid use has been shown to improve survival in patients with bacterial meningitis, tuberculous meningitis, tuberculous pericarditis, severe typhoid fever, tetanus, or pneumocystis pneumonia with moderate to severe hypoxemia.1 Corticosteroid use in many other infections has been studied, and for many infections, symptomatic benefit has been shown. Berkvist and Sjobeck studied 112 patients admitted to the hospital with lower-extremity erysipelas/cellulitis and randomized the patients to receive prednisolone or placebo in addition to antibiotic treatment.2 The prednisolone-treated patients had a shorter hospital stay (5 days vs. 6 days; P less than .01), and had a shorter length of intravenous antibiotic treatment ( 3 days vs. 4 days; P less than .05). The same researchers followed up the study cohort a year later to see if there was any difference in relapse between the steroid- and placebo-treated patients.3 There was no statistically significant difference in relapse (six patients treated with prednisolone relapsed, compared with 13 who received placebo). Solomon et al. did a retrospective study of patients admitted with erysipelas/cellulitis over a 7-year period.4 The control group was defined as patients who received antibiotics but did not receive prednisone, while the other patients in the study received both antibiotics and prednisone. The patients who received antibiotics and prednisone had more severe cellulitis (most had bullous cellulitis) than the patients in the control group. Long-term follow-up showed a higher incidence of erythema and recurrence of cellulitis in the control group. The return to full function was faster in the prednisone-treated patients than in the control group.



Back to the case. Which of the following is most important to do for this patient to help prevent future episodes of cellulitis?

A. Daily penicillin.

B. Treatment of tinea pedis.

C. Hydrochlorothiazide treatment for leg edema.

D. Topical triamcinolone treatment of dry skin on legs.



The correct answer here is treatment of concurrent tinea pedis infection. Antibiotic prophylaxis is considered in patients who have multiple recurrent episodes. This patient’s unilateral edema is most likely attributable to the cellulitis and should resolve with therapy, so diuretics would not be indicated. Risk factors for recurrent cellulitis are tinea pedis, obesity, venous insufficiency, and lymphedema.5

 

 

Concheiro and colleagues did a retrospective study of 122 cases of cellulitis and found tinea pedis in 33% of the cases.6 Muller et al. studied the importance of toe web microorganisms and erysipelas and found that the presence of interdigital tinea pedis was correlated with recurrent infection.7 Treatment of tinea pedis is an easily modifiable risk factor in patients with recurrent cellulitis.

Pearls: Consider adding a short course of steroids in patients with more severe erysipelas/cellulitis, as it can decrease hospital stay and IV antibiotics.

Look for tinea pedis and treat if present in patients who have erysipelas/cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Arch Intern Med. 2008 May 26;168(10):1034-46.

2. Scand J Infect Dis 1997;29(4):377-82.

3. Scand J Infect Dis. 1998;30(2):206-7.

4. Isr Med Assoc J. 2018 Mar;20(3):137-40.

5. J Dtsch Dermatol Ges. 2004 Feb;2(2):89-95.

6. Actas Dermosifiliogr. 2009 Dec;100(10):888-94.

7. J Dtsch Dermatol Ges. 2014 Aug;12(8):691-5.

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A 38-year-old man is admitted to the hospital with a painful, swollen left leg. This was not the first instance of this kind for him. He had been admitted for the same problem 3 months earlier. During the earlier admission, he was diagnosed with cellulitis and treated with intravenous cefazolin for 4 days, then discharged on cephalexin with resolution of his swelling and pain. Today, his blood pressure is 120/70, pulse is 90, temperature is 38.2°C, his left leg is edematous from the mid-calf to the ankle, and he has erythema and warmth over the calf. His white blood cell count is 13,000, and a diagnosis of cellulitis is made. Which of the following treatments is most likely to shorten his hospital stay?

Dr. Paauw


A. Vancomycin therapy instead of cefazolin.

B. Piperacillin/tazobactam therapy instead of cefazolin.

C. Prednisolone therapy in addition to antibiotics.

D. Furosemide therapy in addition to antibiotics.

The correct answer is C, prednisolone therapy in addition to antibiotics. Corticosteroids have been used as therapy for a number of infectious diseases, and steroid use has been shown to improve survival in patients with bacterial meningitis, tuberculous meningitis, tuberculous pericarditis, severe typhoid fever, tetanus, or pneumocystis pneumonia with moderate to severe hypoxemia.1 Corticosteroid use in many other infections has been studied, and for many infections, symptomatic benefit has been shown. Berkvist and Sjobeck studied 112 patients admitted to the hospital with lower-extremity erysipelas/cellulitis and randomized the patients to receive prednisolone or placebo in addition to antibiotic treatment.2 The prednisolone-treated patients had a shorter hospital stay (5 days vs. 6 days; P less than .01), and had a shorter length of intravenous antibiotic treatment ( 3 days vs. 4 days; P less than .05). The same researchers followed up the study cohort a year later to see if there was any difference in relapse between the steroid- and placebo-treated patients.3 There was no statistically significant difference in relapse (six patients treated with prednisolone relapsed, compared with 13 who received placebo). Solomon et al. did a retrospective study of patients admitted with erysipelas/cellulitis over a 7-year period.4 The control group was defined as patients who received antibiotics but did not receive prednisone, while the other patients in the study received both antibiotics and prednisone. The patients who received antibiotics and prednisone had more severe cellulitis (most had bullous cellulitis) than the patients in the control group. Long-term follow-up showed a higher incidence of erythema and recurrence of cellulitis in the control group. The return to full function was faster in the prednisone-treated patients than in the control group.



Back to the case. Which of the following is most important to do for this patient to help prevent future episodes of cellulitis?

A. Daily penicillin.

B. Treatment of tinea pedis.

C. Hydrochlorothiazide treatment for leg edema.

D. Topical triamcinolone treatment of dry skin on legs.



The correct answer here is treatment of concurrent tinea pedis infection. Antibiotic prophylaxis is considered in patients who have multiple recurrent episodes. This patient’s unilateral edema is most likely attributable to the cellulitis and should resolve with therapy, so diuretics would not be indicated. Risk factors for recurrent cellulitis are tinea pedis, obesity, venous insufficiency, and lymphedema.5

 

 

Concheiro and colleagues did a retrospective study of 122 cases of cellulitis and found tinea pedis in 33% of the cases.6 Muller et al. studied the importance of toe web microorganisms and erysipelas and found that the presence of interdigital tinea pedis was correlated with recurrent infection.7 Treatment of tinea pedis is an easily modifiable risk factor in patients with recurrent cellulitis.

Pearls: Consider adding a short course of steroids in patients with more severe erysipelas/cellulitis, as it can decrease hospital stay and IV antibiotics.

Look for tinea pedis and treat if present in patients who have erysipelas/cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Arch Intern Med. 2008 May 26;168(10):1034-46.

2. Scand J Infect Dis 1997;29(4):377-82.

3. Scand J Infect Dis. 1998;30(2):206-7.

4. Isr Med Assoc J. 2018 Mar;20(3):137-40.

5. J Dtsch Dermatol Ges. 2004 Feb;2(2):89-95.

6. Actas Dermosifiliogr. 2009 Dec;100(10):888-94.

7. J Dtsch Dermatol Ges. 2014 Aug;12(8):691-5.

A 38-year-old man is admitted to the hospital with a painful, swollen left leg. This was not the first instance of this kind for him. He had been admitted for the same problem 3 months earlier. During the earlier admission, he was diagnosed with cellulitis and treated with intravenous cefazolin for 4 days, then discharged on cephalexin with resolution of his swelling and pain. Today, his blood pressure is 120/70, pulse is 90, temperature is 38.2°C, his left leg is edematous from the mid-calf to the ankle, and he has erythema and warmth over the calf. His white blood cell count is 13,000, and a diagnosis of cellulitis is made. Which of the following treatments is most likely to shorten his hospital stay?

Dr. Paauw


A. Vancomycin therapy instead of cefazolin.

B. Piperacillin/tazobactam therapy instead of cefazolin.

C. Prednisolone therapy in addition to antibiotics.

D. Furosemide therapy in addition to antibiotics.

The correct answer is C, prednisolone therapy in addition to antibiotics. Corticosteroids have been used as therapy for a number of infectious diseases, and steroid use has been shown to improve survival in patients with bacterial meningitis, tuberculous meningitis, tuberculous pericarditis, severe typhoid fever, tetanus, or pneumocystis pneumonia with moderate to severe hypoxemia.1 Corticosteroid use in many other infections has been studied, and for many infections, symptomatic benefit has been shown. Berkvist and Sjobeck studied 112 patients admitted to the hospital with lower-extremity erysipelas/cellulitis and randomized the patients to receive prednisolone or placebo in addition to antibiotic treatment.2 The prednisolone-treated patients had a shorter hospital stay (5 days vs. 6 days; P less than .01), and had a shorter length of intravenous antibiotic treatment ( 3 days vs. 4 days; P less than .05). The same researchers followed up the study cohort a year later to see if there was any difference in relapse between the steroid- and placebo-treated patients.3 There was no statistically significant difference in relapse (six patients treated with prednisolone relapsed, compared with 13 who received placebo). Solomon et al. did a retrospective study of patients admitted with erysipelas/cellulitis over a 7-year period.4 The control group was defined as patients who received antibiotics but did not receive prednisone, while the other patients in the study received both antibiotics and prednisone. The patients who received antibiotics and prednisone had more severe cellulitis (most had bullous cellulitis) than the patients in the control group. Long-term follow-up showed a higher incidence of erythema and recurrence of cellulitis in the control group. The return to full function was faster in the prednisone-treated patients than in the control group.



Back to the case. Which of the following is most important to do for this patient to help prevent future episodes of cellulitis?

A. Daily penicillin.

B. Treatment of tinea pedis.

C. Hydrochlorothiazide treatment for leg edema.

D. Topical triamcinolone treatment of dry skin on legs.



The correct answer here is treatment of concurrent tinea pedis infection. Antibiotic prophylaxis is considered in patients who have multiple recurrent episodes. This patient’s unilateral edema is most likely attributable to the cellulitis and should resolve with therapy, so diuretics would not be indicated. Risk factors for recurrent cellulitis are tinea pedis, obesity, venous insufficiency, and lymphedema.5

 

 

Concheiro and colleagues did a retrospective study of 122 cases of cellulitis and found tinea pedis in 33% of the cases.6 Muller et al. studied the importance of toe web microorganisms and erysipelas and found that the presence of interdigital tinea pedis was correlated with recurrent infection.7 Treatment of tinea pedis is an easily modifiable risk factor in patients with recurrent cellulitis.

Pearls: Consider adding a short course of steroids in patients with more severe erysipelas/cellulitis, as it can decrease hospital stay and IV antibiotics.

Look for tinea pedis and treat if present in patients who have erysipelas/cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Arch Intern Med. 2008 May 26;168(10):1034-46.

2. Scand J Infect Dis 1997;29(4):377-82.

3. Scand J Infect Dis. 1998;30(2):206-7.

4. Isr Med Assoc J. 2018 Mar;20(3):137-40.

5. J Dtsch Dermatol Ges. 2004 Feb;2(2):89-95.

6. Actas Dermosifiliogr. 2009 Dec;100(10):888-94.

7. J Dtsch Dermatol Ges. 2014 Aug;12(8):691-5.

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Artesunate to become first-line malaria treatment in U.S.

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Changed
Fri, 03/29/2019 - 12:07

Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.

Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.

Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.

About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.

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Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.

Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.

Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.

About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.

Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.

Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.

Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.

About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.

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Ticagrelor reversal agent looks promising

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Tue, 04/23/2019 - 16:39

– A novel targeted ticagrelor reversal agent demonstrated rapid and sustained reversal of the potent antiplatelet agent in a phase 1 proof-of-concept study, Deepak L. Bhatt, MD, reported at the annual meeting of the American College of Cardiology.

Dr. Deepak L. Bhatt

“Hopefully the FDA will view this as something that really is a breakthrough,” commented Dr. Bhatt, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard University, both in Boston.

Why a breakthrough? Because despite recent major advances in the ability to reverse the action of the direct-acting oral anticoagulants and thereby greatly improve their safety margin, there have been no parallel developments with regard to the potent antiplatelet agents ticagrelor (Brilinta), prasugrel (Effient), and clopidogrel. The effects of these antiplatelet drugs take 3-5 days to dissipate after they’ve been stopped, which is highly problematic when they’ve induced catastrophic bleeding or a patient requires emergent or urgent surgery, the cardiologist explained.



“The ability to reverse tigracelor’s antiplatelet effects rapidly could distinguish it from other antiplatelet agents such as prasugrel or even generic clopidogrel and, for that matter, even aspirin,” Dr. Bhatt said.

The ticagrelor reversal agent, known for now as PB2452, is an intravenously administered recombinant human immunoglobulin G1 monoclonal antibody antigen-binding fragment. It binds specifically and with high affinity to ticagrelor and its active metabolite. In the phase 1, placebo-controlled, double-blind study conducted in 64 healthy volunteers pretreated with ticagrelor for 48 hours, it reversed oral ticagrelor’s antiplatelet effects within 5 minutes and, with prolonged infusion, showed sustained effect for at least 20 hours.

The only adverse events observed in blinded assessment were minor injection site issues.

PB2452 is specific to ticagrelor and will not reverse the activity of other potent antiplatelet agents. Indeed, because of their chemical structure, neither prasugrel nor clopidogrel is reversible, according to Dr. Bhatt.

 

 


He said the developmental game plan for the ticagrelor reversal agent is initially to get it approved by the Food and Drug Administration for ticagrelor-related catastrophic bleeding, such as intracranial hemorrhage, since there is a recognized major unmet need in such situations. But as shown in the phase 1 study, BP2452 is potentially titratable by varying the size of the initial bolus dose and the dosing and duration of the subsequent infusion. So after initial approval for catastrophic bleeding, it makes sense to branch out and conduct further studies establishing the reversal agent’s value for prevention of bleeding complications caused by ticagrelor. An example might be a patient on ticagrelor because she recently received a stent in her left main coronary artery who falls and breaks her hip, and her surgeon says she needs surgery right away.

“If someone on ticagrelor came in with an intracranial hemorrhage, you’d want rapid reversal and have it sustained for as many days as the neurologist advises, whereas maybe if someone came in on ticagrelor after placement of a left main stent and you needed to do a lumbar puncture, you’d want to reverse the antiplatelet effect for the LP, and then if things go smoothly you’d want to get the ticagrelor back on board so the stent doesn’t thrombose. But that type of more precise dosing will require further work,” according to the cardiologist.

Discussant Barbara S. Wiggins, PharmD, commented, “We’ve been fortunate to have reversal agents come out for oral anticoagulants, but in terms of antiplatelet activity we’ve not been able to be successful with platelet transfusions. So having a reversal agent added to our armamentarium certainly is something that’s desirable.”

The phase 1 study of PB2452 indicates the monoclonal antibody checks the key boxes one looks for in a reversal agent: quick onset, long duration of effect, lack of a rebound in platelet activity after drug cessation, and potential for tailored titration. Of course, data on efficacy outcomes will also be necessary, noted Dr. Wiggins, a clinical pharmacologist at the Medical University of South Carolina, Charleston.

She added that she was favorably impressed that Dr. Bhatt and his coinvestigators went to the trouble of convincingly demonstrating reversal of ticagrelor’s antiplatelet effects using three different assays: light transmission aggregometry, which is considered the standard, as well as the point-of-care VerifyNow P2Y12 assay and the modified CY-QUANT assay.

The phase 1 study was funded by PhaseBio Pharmaceuticals. Dr. Bhatt reported the company provided a research grant directly to Brigham and Women’s Hospital.

Simultaneous with Dr. Bhatt’s presentation, the study results were published online (N Engl J Med. 2019 Mar 17. doi: 10.1056/NEJMoa1901778).
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– A novel targeted ticagrelor reversal agent demonstrated rapid and sustained reversal of the potent antiplatelet agent in a phase 1 proof-of-concept study, Deepak L. Bhatt, MD, reported at the annual meeting of the American College of Cardiology.

Dr. Deepak L. Bhatt

“Hopefully the FDA will view this as something that really is a breakthrough,” commented Dr. Bhatt, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard University, both in Boston.

Why a breakthrough? Because despite recent major advances in the ability to reverse the action of the direct-acting oral anticoagulants and thereby greatly improve their safety margin, there have been no parallel developments with regard to the potent antiplatelet agents ticagrelor (Brilinta), prasugrel (Effient), and clopidogrel. The effects of these antiplatelet drugs take 3-5 days to dissipate after they’ve been stopped, which is highly problematic when they’ve induced catastrophic bleeding or a patient requires emergent or urgent surgery, the cardiologist explained.



“The ability to reverse tigracelor’s antiplatelet effects rapidly could distinguish it from other antiplatelet agents such as prasugrel or even generic clopidogrel and, for that matter, even aspirin,” Dr. Bhatt said.

The ticagrelor reversal agent, known for now as PB2452, is an intravenously administered recombinant human immunoglobulin G1 monoclonal antibody antigen-binding fragment. It binds specifically and with high affinity to ticagrelor and its active metabolite. In the phase 1, placebo-controlled, double-blind study conducted in 64 healthy volunteers pretreated with ticagrelor for 48 hours, it reversed oral ticagrelor’s antiplatelet effects within 5 minutes and, with prolonged infusion, showed sustained effect for at least 20 hours.

The only adverse events observed in blinded assessment were minor injection site issues.

PB2452 is specific to ticagrelor and will not reverse the activity of other potent antiplatelet agents. Indeed, because of their chemical structure, neither prasugrel nor clopidogrel is reversible, according to Dr. Bhatt.

 

 


He said the developmental game plan for the ticagrelor reversal agent is initially to get it approved by the Food and Drug Administration for ticagrelor-related catastrophic bleeding, such as intracranial hemorrhage, since there is a recognized major unmet need in such situations. But as shown in the phase 1 study, BP2452 is potentially titratable by varying the size of the initial bolus dose and the dosing and duration of the subsequent infusion. So after initial approval for catastrophic bleeding, it makes sense to branch out and conduct further studies establishing the reversal agent’s value for prevention of bleeding complications caused by ticagrelor. An example might be a patient on ticagrelor because she recently received a stent in her left main coronary artery who falls and breaks her hip, and her surgeon says she needs surgery right away.

“If someone on ticagrelor came in with an intracranial hemorrhage, you’d want rapid reversal and have it sustained for as many days as the neurologist advises, whereas maybe if someone came in on ticagrelor after placement of a left main stent and you needed to do a lumbar puncture, you’d want to reverse the antiplatelet effect for the LP, and then if things go smoothly you’d want to get the ticagrelor back on board so the stent doesn’t thrombose. But that type of more precise dosing will require further work,” according to the cardiologist.

Discussant Barbara S. Wiggins, PharmD, commented, “We’ve been fortunate to have reversal agents come out for oral anticoagulants, but in terms of antiplatelet activity we’ve not been able to be successful with platelet transfusions. So having a reversal agent added to our armamentarium certainly is something that’s desirable.”

The phase 1 study of PB2452 indicates the monoclonal antibody checks the key boxes one looks for in a reversal agent: quick onset, long duration of effect, lack of a rebound in platelet activity after drug cessation, and potential for tailored titration. Of course, data on efficacy outcomes will also be necessary, noted Dr. Wiggins, a clinical pharmacologist at the Medical University of South Carolina, Charleston.

She added that she was favorably impressed that Dr. Bhatt and his coinvestigators went to the trouble of convincingly demonstrating reversal of ticagrelor’s antiplatelet effects using three different assays: light transmission aggregometry, which is considered the standard, as well as the point-of-care VerifyNow P2Y12 assay and the modified CY-QUANT assay.

The phase 1 study was funded by PhaseBio Pharmaceuticals. Dr. Bhatt reported the company provided a research grant directly to Brigham and Women’s Hospital.

Simultaneous with Dr. Bhatt’s presentation, the study results were published online (N Engl J Med. 2019 Mar 17. doi: 10.1056/NEJMoa1901778).

– A novel targeted ticagrelor reversal agent demonstrated rapid and sustained reversal of the potent antiplatelet agent in a phase 1 proof-of-concept study, Deepak L. Bhatt, MD, reported at the annual meeting of the American College of Cardiology.

Dr. Deepak L. Bhatt

“Hopefully the FDA will view this as something that really is a breakthrough,” commented Dr. Bhatt, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard University, both in Boston.

Why a breakthrough? Because despite recent major advances in the ability to reverse the action of the direct-acting oral anticoagulants and thereby greatly improve their safety margin, there have been no parallel developments with regard to the potent antiplatelet agents ticagrelor (Brilinta), prasugrel (Effient), and clopidogrel. The effects of these antiplatelet drugs take 3-5 days to dissipate after they’ve been stopped, which is highly problematic when they’ve induced catastrophic bleeding or a patient requires emergent or urgent surgery, the cardiologist explained.



“The ability to reverse tigracelor’s antiplatelet effects rapidly could distinguish it from other antiplatelet agents such as prasugrel or even generic clopidogrel and, for that matter, even aspirin,” Dr. Bhatt said.

The ticagrelor reversal agent, known for now as PB2452, is an intravenously administered recombinant human immunoglobulin G1 monoclonal antibody antigen-binding fragment. It binds specifically and with high affinity to ticagrelor and its active metabolite. In the phase 1, placebo-controlled, double-blind study conducted in 64 healthy volunteers pretreated with ticagrelor for 48 hours, it reversed oral ticagrelor’s antiplatelet effects within 5 minutes and, with prolonged infusion, showed sustained effect for at least 20 hours.

The only adverse events observed in blinded assessment were minor injection site issues.

PB2452 is specific to ticagrelor and will not reverse the activity of other potent antiplatelet agents. Indeed, because of their chemical structure, neither prasugrel nor clopidogrel is reversible, according to Dr. Bhatt.

 

 


He said the developmental game plan for the ticagrelor reversal agent is initially to get it approved by the Food and Drug Administration for ticagrelor-related catastrophic bleeding, such as intracranial hemorrhage, since there is a recognized major unmet need in such situations. But as shown in the phase 1 study, BP2452 is potentially titratable by varying the size of the initial bolus dose and the dosing and duration of the subsequent infusion. So after initial approval for catastrophic bleeding, it makes sense to branch out and conduct further studies establishing the reversal agent’s value for prevention of bleeding complications caused by ticagrelor. An example might be a patient on ticagrelor because she recently received a stent in her left main coronary artery who falls and breaks her hip, and her surgeon says she needs surgery right away.

“If someone on ticagrelor came in with an intracranial hemorrhage, you’d want rapid reversal and have it sustained for as many days as the neurologist advises, whereas maybe if someone came in on ticagrelor after placement of a left main stent and you needed to do a lumbar puncture, you’d want to reverse the antiplatelet effect for the LP, and then if things go smoothly you’d want to get the ticagrelor back on board so the stent doesn’t thrombose. But that type of more precise dosing will require further work,” according to the cardiologist.

Discussant Barbara S. Wiggins, PharmD, commented, “We’ve been fortunate to have reversal agents come out for oral anticoagulants, but in terms of antiplatelet activity we’ve not been able to be successful with platelet transfusions. So having a reversal agent added to our armamentarium certainly is something that’s desirable.”

The phase 1 study of PB2452 indicates the monoclonal antibody checks the key boxes one looks for in a reversal agent: quick onset, long duration of effect, lack of a rebound in platelet activity after drug cessation, and potential for tailored titration. Of course, data on efficacy outcomes will also be necessary, noted Dr. Wiggins, a clinical pharmacologist at the Medical University of South Carolina, Charleston.

She added that she was favorably impressed that Dr. Bhatt and his coinvestigators went to the trouble of convincingly demonstrating reversal of ticagrelor’s antiplatelet effects using three different assays: light transmission aggregometry, which is considered the standard, as well as the point-of-care VerifyNow P2Y12 assay and the modified CY-QUANT assay.

The phase 1 study was funded by PhaseBio Pharmaceuticals. Dr. Bhatt reported the company provided a research grant directly to Brigham and Women’s Hospital.

Simultaneous with Dr. Bhatt’s presentation, the study results were published online (N Engl J Med. 2019 Mar 17. doi: 10.1056/NEJMoa1901778).
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Key clinical point: Oral ticagrelor’s antiplatelet effect was reversed within 5 minutes by a novel targeted monoclonal antibody.  

Major finding: A novel targeted monoclonal antibody reversed oral ticagrelor’s antiplatelet effects within 5 minutes and, with prolonged infusion, showed sustained effect for at least 20 hours. 

Study details: This phase 1 study included 64 healthy subjects pretreated with 48 hours of ticagrelor before receiving various doses of the reversal agent or placebo.  

Disclosures: The study was funded by PhaseBio Pharmaceuticals, which provided a research grant directly to Brigham and Women’s Hospital.  

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More fiber looks safe, might benefit ICU patients

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Thu, 03/28/2019 - 15:10

 

MIAMI – High-fiber diets in the ICU were well tolerated and led to desirable shifts in the gut microbiome that correlated with decreased abdominal distension, according to the results of an observational cohort study.

Yichun Fu

“Higher fiber intake was associated with greater preservation of short-chain fatty acid–producing bacteria, even after we adjusted for antibiotics and acute severity of illness,” said Yichun Fu, a fourth-year medical student at Columbia University, New York, at the annual Gut Microbiota for Health World Summit.

She explained that, after 72 hours on the high-fiber diet, only 11% of patients had abdominal distension noted in their EMRs, compared with 36% of patients who received no dietary fiber (P less than .01). Fiber was not associated with bowel obstruction, high gastric residuals, enteric infections, edema, or diarrhea. She and her associates presented the findings in a poster at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.

Dietary fiber is a prebiotic that increases the abundance of short-chain fatty acid (SCFA)–producing bacteria in the gut. Growing evidence links these bacteria and their metabolites – such as acetate, propionate, and butyrate – to immunomodulatory benefits and suggests that they help maintain gut barrier function, glucose homeostasis, adipose tissue lipolysis, and normal blood pressure. Thus, fiber for ICU patients might make sense, but relevant dietary guidelines rarely address the topic. In practice, fiber is often withheld in the ICU because of concerns that it might cause bloating or diarrhea, Ms. Fu said.

For the study, the researchers performed 16s ribosomal RNA sequencing on baseline and 72-hour rectal swabs collected from 129 consecutive adults newly admitted to the ICU. Patients were eligible for the study regardless of whether they received nothing by mouth, enteral feeding, or food by mouth. They were grouped in tertiles based on fiber intake over 72 hours, corrected by caloric intake. The resulting groups were dubbed “no fiber” (median and interquartile range, 0 grams), “low fiber” (median, 11.2 g; IQR, 3.8-18.2 g), and “high fiber” (median, 39.3 g; IQR, 4.7-50.2 g).

Patients in these three groups had a similar relative abundance of SCFA-producing bacteria at baseline. At 72 hours, the high-fiber group had a significantly greater relative abundance of SCFA producers than the no fiber group (P = .01). Compared with no fiber, high-fiber intake also correlated with significantly increased gut bacterial diversity (P = .04) and a lower relative abundance of Enterococcus bacteria (P less than .01). None of these measures differed significantly between the no-fiber and low-fiber groups.

The groups were demographically and clinically similar at baseline, except that the high-fiber group had lower Acute Physiology and Chronic Health Evaluation IV scores (P = .02) and was less likely to receive antibiotics, mechanical ventilation, hemodialysis, or vasopressors (P less than .01). After correcting for these differences, each 10-g increase in fiber intake over 72 hours correlated with a 0.3% median increase in the relative abundance of SCFA-producing bacteria (estimated IQR, 0.10%-0.46%; P less than .01).

“Fiber may be a simple candidate therapy for ICU patients,” the researchers concluded. The team is now designing a prospective, interventional study to further test whether fiber can modify the gut microbiome to benefit ICU patients, Ms. Fu explained.

Funders included the American Gastroenterological Association, the National Institutes of Health, and the Feldstein Medical Foundation. Ms. Fu reported no competing interests.

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MIAMI – High-fiber diets in the ICU were well tolerated and led to desirable shifts in the gut microbiome that correlated with decreased abdominal distension, according to the results of an observational cohort study.

Yichun Fu

“Higher fiber intake was associated with greater preservation of short-chain fatty acid–producing bacteria, even after we adjusted for antibiotics and acute severity of illness,” said Yichun Fu, a fourth-year medical student at Columbia University, New York, at the annual Gut Microbiota for Health World Summit.

She explained that, after 72 hours on the high-fiber diet, only 11% of patients had abdominal distension noted in their EMRs, compared with 36% of patients who received no dietary fiber (P less than .01). Fiber was not associated with bowel obstruction, high gastric residuals, enteric infections, edema, or diarrhea. She and her associates presented the findings in a poster at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.

Dietary fiber is a prebiotic that increases the abundance of short-chain fatty acid (SCFA)–producing bacteria in the gut. Growing evidence links these bacteria and their metabolites – such as acetate, propionate, and butyrate – to immunomodulatory benefits and suggests that they help maintain gut barrier function, glucose homeostasis, adipose tissue lipolysis, and normal blood pressure. Thus, fiber for ICU patients might make sense, but relevant dietary guidelines rarely address the topic. In practice, fiber is often withheld in the ICU because of concerns that it might cause bloating or diarrhea, Ms. Fu said.

For the study, the researchers performed 16s ribosomal RNA sequencing on baseline and 72-hour rectal swabs collected from 129 consecutive adults newly admitted to the ICU. Patients were eligible for the study regardless of whether they received nothing by mouth, enteral feeding, or food by mouth. They were grouped in tertiles based on fiber intake over 72 hours, corrected by caloric intake. The resulting groups were dubbed “no fiber” (median and interquartile range, 0 grams), “low fiber” (median, 11.2 g; IQR, 3.8-18.2 g), and “high fiber” (median, 39.3 g; IQR, 4.7-50.2 g).

Patients in these three groups had a similar relative abundance of SCFA-producing bacteria at baseline. At 72 hours, the high-fiber group had a significantly greater relative abundance of SCFA producers than the no fiber group (P = .01). Compared with no fiber, high-fiber intake also correlated with significantly increased gut bacterial diversity (P = .04) and a lower relative abundance of Enterococcus bacteria (P less than .01). None of these measures differed significantly between the no-fiber and low-fiber groups.

The groups were demographically and clinically similar at baseline, except that the high-fiber group had lower Acute Physiology and Chronic Health Evaluation IV scores (P = .02) and was less likely to receive antibiotics, mechanical ventilation, hemodialysis, or vasopressors (P less than .01). After correcting for these differences, each 10-g increase in fiber intake over 72 hours correlated with a 0.3% median increase in the relative abundance of SCFA-producing bacteria (estimated IQR, 0.10%-0.46%; P less than .01).

“Fiber may be a simple candidate therapy for ICU patients,” the researchers concluded. The team is now designing a prospective, interventional study to further test whether fiber can modify the gut microbiome to benefit ICU patients, Ms. Fu explained.

Funders included the American Gastroenterological Association, the National Institutes of Health, and the Feldstein Medical Foundation. Ms. Fu reported no competing interests.

 

MIAMI – High-fiber diets in the ICU were well tolerated and led to desirable shifts in the gut microbiome that correlated with decreased abdominal distension, according to the results of an observational cohort study.

Yichun Fu

“Higher fiber intake was associated with greater preservation of short-chain fatty acid–producing bacteria, even after we adjusted for antibiotics and acute severity of illness,” said Yichun Fu, a fourth-year medical student at Columbia University, New York, at the annual Gut Microbiota for Health World Summit.

She explained that, after 72 hours on the high-fiber diet, only 11% of patients had abdominal distension noted in their EMRs, compared with 36% of patients who received no dietary fiber (P less than .01). Fiber was not associated with bowel obstruction, high gastric residuals, enteric infections, edema, or diarrhea. She and her associates presented the findings in a poster at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.

Dietary fiber is a prebiotic that increases the abundance of short-chain fatty acid (SCFA)–producing bacteria in the gut. Growing evidence links these bacteria and their metabolites – such as acetate, propionate, and butyrate – to immunomodulatory benefits and suggests that they help maintain gut barrier function, glucose homeostasis, adipose tissue lipolysis, and normal blood pressure. Thus, fiber for ICU patients might make sense, but relevant dietary guidelines rarely address the topic. In practice, fiber is often withheld in the ICU because of concerns that it might cause bloating or diarrhea, Ms. Fu said.

For the study, the researchers performed 16s ribosomal RNA sequencing on baseline and 72-hour rectal swabs collected from 129 consecutive adults newly admitted to the ICU. Patients were eligible for the study regardless of whether they received nothing by mouth, enteral feeding, or food by mouth. They were grouped in tertiles based on fiber intake over 72 hours, corrected by caloric intake. The resulting groups were dubbed “no fiber” (median and interquartile range, 0 grams), “low fiber” (median, 11.2 g; IQR, 3.8-18.2 g), and “high fiber” (median, 39.3 g; IQR, 4.7-50.2 g).

Patients in these three groups had a similar relative abundance of SCFA-producing bacteria at baseline. At 72 hours, the high-fiber group had a significantly greater relative abundance of SCFA producers than the no fiber group (P = .01). Compared with no fiber, high-fiber intake also correlated with significantly increased gut bacterial diversity (P = .04) and a lower relative abundance of Enterococcus bacteria (P less than .01). None of these measures differed significantly between the no-fiber and low-fiber groups.

The groups were demographically and clinically similar at baseline, except that the high-fiber group had lower Acute Physiology and Chronic Health Evaluation IV scores (P = .02) and was less likely to receive antibiotics, mechanical ventilation, hemodialysis, or vasopressors (P less than .01). After correcting for these differences, each 10-g increase in fiber intake over 72 hours correlated with a 0.3% median increase in the relative abundance of SCFA-producing bacteria (estimated IQR, 0.10%-0.46%; P less than .01).

“Fiber may be a simple candidate therapy for ICU patients,” the researchers concluded. The team is now designing a prospective, interventional study to further test whether fiber can modify the gut microbiome to benefit ICU patients, Ms. Fu explained.

Funders included the American Gastroenterological Association, the National Institutes of Health, and the Feldstein Medical Foundation. Ms. Fu reported no competing interests.

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AAP updates 2019-2020 flu vaccine recommendations to include nasal spray

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Thu, 03/28/2019 - 13:07

Although the American Academy of Pediatrics had cited a preference for injected flu vaccines for children during the 2018-2019 flu season, this year’s recommendations say either that or the nasal spray formulation are acceptable, according to a press release. The Centers for Disease Control and Prevention has given similar guidance.

Louise A. Koenig/MDedge News

Because the spray did not work as well against A/H1N1 as the injected vaccine had during the 2013-2014 and 2014-2015 seasons, the AAP did not recommend the spray during the 2015-2016 and 2016-2017 seasons. However, in 2017 the spray’s manufacturer included a new strain of A/H1N1, and new data has supported the spray’s effectiveness against some strains.

The AAP recommends all children aged 6 months and older should be vaccinated, but the flu nasal spray is approved only for nonpregnant patients aged 2-49 years, according to the CDC. That said, the spray is especially appropriate for patients who refuse to receive the injected form, so the choice of formulation is at the pediatrician’s discretion, according to the AAP release.

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Although the American Academy of Pediatrics had cited a preference for injected flu vaccines for children during the 2018-2019 flu season, this year’s recommendations say either that or the nasal spray formulation are acceptable, according to a press release. The Centers for Disease Control and Prevention has given similar guidance.

Louise A. Koenig/MDedge News

Because the spray did not work as well against A/H1N1 as the injected vaccine had during the 2013-2014 and 2014-2015 seasons, the AAP did not recommend the spray during the 2015-2016 and 2016-2017 seasons. However, in 2017 the spray’s manufacturer included a new strain of A/H1N1, and new data has supported the spray’s effectiveness against some strains.

The AAP recommends all children aged 6 months and older should be vaccinated, but the flu nasal spray is approved only for nonpregnant patients aged 2-49 years, according to the CDC. That said, the spray is especially appropriate for patients who refuse to receive the injected form, so the choice of formulation is at the pediatrician’s discretion, according to the AAP release.

Although the American Academy of Pediatrics had cited a preference for injected flu vaccines for children during the 2018-2019 flu season, this year’s recommendations say either that or the nasal spray formulation are acceptable, according to a press release. The Centers for Disease Control and Prevention has given similar guidance.

Louise A. Koenig/MDedge News

Because the spray did not work as well against A/H1N1 as the injected vaccine had during the 2013-2014 and 2014-2015 seasons, the AAP did not recommend the spray during the 2015-2016 and 2016-2017 seasons. However, in 2017 the spray’s manufacturer included a new strain of A/H1N1, and new data has supported the spray’s effectiveness against some strains.

The AAP recommends all children aged 6 months and older should be vaccinated, but the flu nasal spray is approved only for nonpregnant patients aged 2-49 years, according to the CDC. That said, the spray is especially appropriate for patients who refuse to receive the injected form, so the choice of formulation is at the pediatrician’s discretion, according to the AAP release.

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Report calls for focus on ‘subpopulations’ to fight opioid epidemic

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Most people who could benefit from FDA-approved medications for opioid use disorder do not receive them, and access to those treatments is not equitable, according to a new consensus study report from the National Academies of Sciences, Engineering, and Medicine.

Dr. Victor J. Dzau

“Methadone, buprenorphine, and extended-release naltrexone are safe and highly effective medications that are already approved by the U.S. Food and Drug Administration to treat OUD,” the report said. “These medications save lives, but the majority of people with OUD in the United States receive no treatment at all.”

The report, called “Medications for Opioid Use Disorder Save Lives,” said a critical factor in addressing the crisis is “confronting the major barriers” to using those medications. It also said additional research will be needed to address opioid use disorder among subpopulations in the United States, such as adolescents, older adults, people with comorbidities, racial and ethnic groups, and people with low socioeconomic status. The National Academies’ report was sponsored by NIDA and SAMHSA.

A few weeks before the release of National Academies report, the National Academy of Medicine (NAM) held a webinar providing details on its Action Collaborative on Countering the U.S. Opioid Epidemic. The collaborative, a partnership of public and private stakeholders, aims to address the opioid crisis through a multidisciplinary, cross-sector effort.

The collaborative is represented by federal agencies, state and local governments, health care systems, provider groups, nonprofits, payers, industry, academia, patient organizations, and communities across about 55 organizations, according to Victor J. Dzau, MD, chair of the Action Collaborative and current NAM president. Over a 2-year period, the collaborative’s goal is to accelerate progress in overcoming the opioid crisis by recognizing the challenges, research gaps, and needs of organizations involved in the crisis and “elevate and accelerate evidence-based, multisectoral, and interprofessional solutions,” he said.

“This is not a problem that can be solved by a single sector. It is truly a whole of society problem,” said Adm. Brett P. Giroir, MD, assistant secretary for health at the U.S. Department of Health and Human Services, said during the webinar. “And the only way that we are going to be able to begin making inroads to reverse the trends of this crisis is if we work together.” Dr. Giroir also serves as cochair of the steering committee for the collaborative.

In its overview of the collaborative, the NAM outlined four working groups developed through a series of surveys and planning meetings that would identify the resources that currently exist to combat the opioid epidemic and determine which resources still need to be developed. In the Health Professional Education and Training Working Group, for example, the objective is to examine what is being taught to health professionals about acute and chronic pain management at an accreditation, certification, and regulatory level to develop educational tools based around knowledge gaps in those areas and analyze how the new resources are affecting health professions after they have been adopted, said Steve Singer, PhD, vice president of education and outreach at the Accreditation Council for Graduate Medical Education and colead of the working group.“Our goal is really to provide guidance and resources across the continuum of health professions and education with an interprofessional – and patient-informed view,” he said.

Dr. Helen Burstin

The Opioid Prescribing Guidelines and Evidence Standards Working Group plans to address the disparities in prescribing and tapering guidelines for acute and chronic pain as well as identify where pain management guidelines in different specialties “cannot be justified,” based on available evidence.

“Further, we think it’s really important to not just have guidelines that will sit on a shelf, but we also want to think about how we can support implementation of these guidelines into practice ... ” said Helen Burstin, MD, MPH, executive vice president and CEO for the Council of Medical Specialty Societies and colead of the working group.

Alonzo L. Plough, PhD, MPH, vice president of research-evaluation-learning at the Robert Wood Johnson Foundation and colead of the Prevention, Treatment, and Recovery Services Working Group, explained that the goal of his group is to identify the “essential elements and components” and best practices of prevention, treatment, and recovery for OUD. He noted that, although the working group will not be able to reach all patient populations affected by OUD, it has discussed targeting vulnerable high-risk populations, such as those involved in the criminal justice system, homeless veterans, mothers, and children.

“This is an ecosystem that requires great concentration and effort to make sure that there are integrated approaches throughout the continuum that work for patients and clients from different walks of life, and I think that our overall guidance is how we can recognize and use evidence to find those approaches and build on them for guidance,” he said.

The Research, Data, and Metrics Needs Working Group is tasked with collaborating with the other groups to obtain currently available information and identify what barriers exist to greater transparency, sharing and interoperability of data as well as what gaps in research currently exist that would further the collaborative’s mission, said Kelly J. Clark, MD, MBA, of the ASAM. “It is simply critical for us to utilize the data that’s out there, to pool it into more actionable information – and then to act on it,” Dr. Clark said.

The NAM is seeking new organizations interested in joining the collaborative as a network organization, which would receive updates and provide input on the collaborative but would not be a part of the working groups.

The first public meeting of the Action Collaborative on Countering the U.S. Opioid Epidemic will take place on April 30, 2019, in Washington.

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Most people who could benefit from FDA-approved medications for opioid use disorder do not receive them, and access to those treatments is not equitable, according to a new consensus study report from the National Academies of Sciences, Engineering, and Medicine.

Dr. Victor J. Dzau

“Methadone, buprenorphine, and extended-release naltrexone are safe and highly effective medications that are already approved by the U.S. Food and Drug Administration to treat OUD,” the report said. “These medications save lives, but the majority of people with OUD in the United States receive no treatment at all.”

The report, called “Medications for Opioid Use Disorder Save Lives,” said a critical factor in addressing the crisis is “confronting the major barriers” to using those medications. It also said additional research will be needed to address opioid use disorder among subpopulations in the United States, such as adolescents, older adults, people with comorbidities, racial and ethnic groups, and people with low socioeconomic status. The National Academies’ report was sponsored by NIDA and SAMHSA.

A few weeks before the release of National Academies report, the National Academy of Medicine (NAM) held a webinar providing details on its Action Collaborative on Countering the U.S. Opioid Epidemic. The collaborative, a partnership of public and private stakeholders, aims to address the opioid crisis through a multidisciplinary, cross-sector effort.

The collaborative is represented by federal agencies, state and local governments, health care systems, provider groups, nonprofits, payers, industry, academia, patient organizations, and communities across about 55 organizations, according to Victor J. Dzau, MD, chair of the Action Collaborative and current NAM president. Over a 2-year period, the collaborative’s goal is to accelerate progress in overcoming the opioid crisis by recognizing the challenges, research gaps, and needs of organizations involved in the crisis and “elevate and accelerate evidence-based, multisectoral, and interprofessional solutions,” he said.

“This is not a problem that can be solved by a single sector. It is truly a whole of society problem,” said Adm. Brett P. Giroir, MD, assistant secretary for health at the U.S. Department of Health and Human Services, said during the webinar. “And the only way that we are going to be able to begin making inroads to reverse the trends of this crisis is if we work together.” Dr. Giroir also serves as cochair of the steering committee for the collaborative.

In its overview of the collaborative, the NAM outlined four working groups developed through a series of surveys and planning meetings that would identify the resources that currently exist to combat the opioid epidemic and determine which resources still need to be developed. In the Health Professional Education and Training Working Group, for example, the objective is to examine what is being taught to health professionals about acute and chronic pain management at an accreditation, certification, and regulatory level to develop educational tools based around knowledge gaps in those areas and analyze how the new resources are affecting health professions after they have been adopted, said Steve Singer, PhD, vice president of education and outreach at the Accreditation Council for Graduate Medical Education and colead of the working group.“Our goal is really to provide guidance and resources across the continuum of health professions and education with an interprofessional – and patient-informed view,” he said.

Dr. Helen Burstin

The Opioid Prescribing Guidelines and Evidence Standards Working Group plans to address the disparities in prescribing and tapering guidelines for acute and chronic pain as well as identify where pain management guidelines in different specialties “cannot be justified,” based on available evidence.

“Further, we think it’s really important to not just have guidelines that will sit on a shelf, but we also want to think about how we can support implementation of these guidelines into practice ... ” said Helen Burstin, MD, MPH, executive vice president and CEO for the Council of Medical Specialty Societies and colead of the working group.

Alonzo L. Plough, PhD, MPH, vice president of research-evaluation-learning at the Robert Wood Johnson Foundation and colead of the Prevention, Treatment, and Recovery Services Working Group, explained that the goal of his group is to identify the “essential elements and components” and best practices of prevention, treatment, and recovery for OUD. He noted that, although the working group will not be able to reach all patient populations affected by OUD, it has discussed targeting vulnerable high-risk populations, such as those involved in the criminal justice system, homeless veterans, mothers, and children.

“This is an ecosystem that requires great concentration and effort to make sure that there are integrated approaches throughout the continuum that work for patients and clients from different walks of life, and I think that our overall guidance is how we can recognize and use evidence to find those approaches and build on them for guidance,” he said.

The Research, Data, and Metrics Needs Working Group is tasked with collaborating with the other groups to obtain currently available information and identify what barriers exist to greater transparency, sharing and interoperability of data as well as what gaps in research currently exist that would further the collaborative’s mission, said Kelly J. Clark, MD, MBA, of the ASAM. “It is simply critical for us to utilize the data that’s out there, to pool it into more actionable information – and then to act on it,” Dr. Clark said.

The NAM is seeking new organizations interested in joining the collaborative as a network organization, which would receive updates and provide input on the collaborative but would not be a part of the working groups.

The first public meeting of the Action Collaborative on Countering the U.S. Opioid Epidemic will take place on April 30, 2019, in Washington.

 

Most people who could benefit from FDA-approved medications for opioid use disorder do not receive them, and access to those treatments is not equitable, according to a new consensus study report from the National Academies of Sciences, Engineering, and Medicine.

Dr. Victor J. Dzau

“Methadone, buprenorphine, and extended-release naltrexone are safe and highly effective medications that are already approved by the U.S. Food and Drug Administration to treat OUD,” the report said. “These medications save lives, but the majority of people with OUD in the United States receive no treatment at all.”

The report, called “Medications for Opioid Use Disorder Save Lives,” said a critical factor in addressing the crisis is “confronting the major barriers” to using those medications. It also said additional research will be needed to address opioid use disorder among subpopulations in the United States, such as adolescents, older adults, people with comorbidities, racial and ethnic groups, and people with low socioeconomic status. The National Academies’ report was sponsored by NIDA and SAMHSA.

A few weeks before the release of National Academies report, the National Academy of Medicine (NAM) held a webinar providing details on its Action Collaborative on Countering the U.S. Opioid Epidemic. The collaborative, a partnership of public and private stakeholders, aims to address the opioid crisis through a multidisciplinary, cross-sector effort.

The collaborative is represented by federal agencies, state and local governments, health care systems, provider groups, nonprofits, payers, industry, academia, patient organizations, and communities across about 55 organizations, according to Victor J. Dzau, MD, chair of the Action Collaborative and current NAM president. Over a 2-year period, the collaborative’s goal is to accelerate progress in overcoming the opioid crisis by recognizing the challenges, research gaps, and needs of organizations involved in the crisis and “elevate and accelerate evidence-based, multisectoral, and interprofessional solutions,” he said.

“This is not a problem that can be solved by a single sector. It is truly a whole of society problem,” said Adm. Brett P. Giroir, MD, assistant secretary for health at the U.S. Department of Health and Human Services, said during the webinar. “And the only way that we are going to be able to begin making inroads to reverse the trends of this crisis is if we work together.” Dr. Giroir also serves as cochair of the steering committee for the collaborative.

In its overview of the collaborative, the NAM outlined four working groups developed through a series of surveys and planning meetings that would identify the resources that currently exist to combat the opioid epidemic and determine which resources still need to be developed. In the Health Professional Education and Training Working Group, for example, the objective is to examine what is being taught to health professionals about acute and chronic pain management at an accreditation, certification, and regulatory level to develop educational tools based around knowledge gaps in those areas and analyze how the new resources are affecting health professions after they have been adopted, said Steve Singer, PhD, vice president of education and outreach at the Accreditation Council for Graduate Medical Education and colead of the working group.“Our goal is really to provide guidance and resources across the continuum of health professions and education with an interprofessional – and patient-informed view,” he said.

Dr. Helen Burstin

The Opioid Prescribing Guidelines and Evidence Standards Working Group plans to address the disparities in prescribing and tapering guidelines for acute and chronic pain as well as identify where pain management guidelines in different specialties “cannot be justified,” based on available evidence.

“Further, we think it’s really important to not just have guidelines that will sit on a shelf, but we also want to think about how we can support implementation of these guidelines into practice ... ” said Helen Burstin, MD, MPH, executive vice president and CEO for the Council of Medical Specialty Societies and colead of the working group.

Alonzo L. Plough, PhD, MPH, vice president of research-evaluation-learning at the Robert Wood Johnson Foundation and colead of the Prevention, Treatment, and Recovery Services Working Group, explained that the goal of his group is to identify the “essential elements and components” and best practices of prevention, treatment, and recovery for OUD. He noted that, although the working group will not be able to reach all patient populations affected by OUD, it has discussed targeting vulnerable high-risk populations, such as those involved in the criminal justice system, homeless veterans, mothers, and children.

“This is an ecosystem that requires great concentration and effort to make sure that there are integrated approaches throughout the continuum that work for patients and clients from different walks of life, and I think that our overall guidance is how we can recognize and use evidence to find those approaches and build on them for guidance,” he said.

The Research, Data, and Metrics Needs Working Group is tasked with collaborating with the other groups to obtain currently available information and identify what barriers exist to greater transparency, sharing and interoperability of data as well as what gaps in research currently exist that would further the collaborative’s mission, said Kelly J. Clark, MD, MBA, of the ASAM. “It is simply critical for us to utilize the data that’s out there, to pool it into more actionable information – and then to act on it,” Dr. Clark said.

The NAM is seeking new organizations interested in joining the collaborative as a network organization, which would receive updates and provide input on the collaborative but would not be a part of the working groups.

The first public meeting of the Action Collaborative on Countering the U.S. Opioid Epidemic will take place on April 30, 2019, in Washington.

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