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Some veterans who present to smaller facilities, such as rural hospitals, are transferred to larger facilities for diagnostic or therapeutic procedures. But that access also can mean hardship for rural veterans by taking them far from family and adding costs. Moreover, complex care coordination can cause “triage mismatch” when the patients are at their most vulnerable: “over-triage”—transferring patients unlikely to benefit and “under-triage”—failing to transfer those likely to benefit.  

Researchers from VA Iowa City Healthcare System and University of Iowa conducted a study to find out what proportion of VHA transfers were potentially avoidable. Their study included all veterans treated in any of 120 VHA emergency departments (EDs) and transferred to a VHA acute care hospital between January 2012 and December 2014.

Potentially avoidable transfers (PATs) were defined as transfers in which the patient was either discharged from the referral ED or admitted to the referral hospital for < 24 hours, without having an invasive procedure. The researchers chose that definition to identify patients whose transfer might have been avoided if real-time specialty telemedicine were available at the index hospital. (They caution that the definition was not intended to suggest that all PATs were inappropriate.)

Over 3 years, 18,852 patients were transferred. Of the total patients transferred, 36% were transferred from 1 VHA ED to another VHA facility. Of the VHA transfers, 8,639 (46%) were transferred to another VHA ED; the rest were transferred to another VHA facility inpatient unit. The median transfer distance was 81.5 miles. Rural residents were transferred 3 times as often as urban residents.

The good news is that PATs are rare. Only 0.8% of VHA ED visits resulted in transfer, and of those, only one-fourth were deemed potentially avoidable. And while rural veterans were more likely to be transferred, PATs were less prevalent among those transfers (20.8% vs 23.9% for urban veterans).

More than half of VHA transfers were for patients diagnosed with mental health, cardiac, and digestive conditions. The top ICD-9 diagnosis related to VHA ED transfer was suicidal ideation. The diagnostic procedures associated with most PATs were mental health (11% potentially avoidable) and cardiac (21% potentially avoidable).

Their research turned up some unexpected data: For example, smaller EDs did not have a higher prevalence of PATs, suggesting that ED size was not associated with transfer appropriateness. And the proportion of PATs was higher in hospitals with > 50% board-certified emergency physicians.

The researchers say their findings highlight important differences between the VHA health care and civilian health care systems, emphasizing that the resources available within the VHA health system “might be unique” and underlining the need for VHA-specific solutions to health care delivery challenges.

 The overall purpose of this study, the researchers say, was to identify areas where novel delivery of specialty care might reduce the need for some VHA transfers. Their analysis provides data for developing targeted intervention, such as ED-based telemedicine or “targeted remote care.”

Patients with mental health conditions—who made up more than one-third of all VHA-to-VHA interfacility transfers, higher than that reported in civilian hospitals—represent a “rich target population” for telehealth, the researchers suggest. They also note that because mental health providers are in critical shortage in most of the US, real-time telemedicine providing psychiatric resources could be an important and timely service.

Nearly half of medical directors of VHA EDs who responded to the VHA Healthcare Analysis and Information Group survey cited the transfer process as “overly burdensome,” and > 65% said administrative processes contribute to delay in transfer. Finding new ways to keep patients local could benefit providers as well.

Some veterans who present to smaller facilities, such as rural hospitals, are transferred to larger facilities for diagnostic or therapeutic procedures. But that access also can mean hardship for rural veterans by taking them far from family and adding costs. Moreover, complex care coordination can cause “triage mismatch” when the patients are at their most vulnerable: “over-triage”—transferring patients unlikely to benefit and “under-triage”—failing to transfer those likely to benefit.  

Researchers from VA Iowa City Healthcare System and University of Iowa conducted a study to find out what proportion of VHA transfers were potentially avoidable. Their study included all veterans treated in any of 120 VHA emergency departments (EDs) and transferred to a VHA acute care hospital between January 2012 and December 2014.

Potentially avoidable transfers (PATs) were defined as transfers in which the patient was either discharged from the referral ED or admitted to the referral hospital for < 24 hours, without having an invasive procedure. The researchers chose that definition to identify patients whose transfer might have been avoided if real-time specialty telemedicine were available at the index hospital. (They caution that the definition was not intended to suggest that all PATs were inappropriate.)

Over 3 years, 18,852 patients were transferred. Of the total patients transferred, 36% were transferred from 1 VHA ED to another VHA facility. Of the VHA transfers, 8,639 (46%) were transferred to another VHA ED; the rest were transferred to another VHA facility inpatient unit. The median transfer distance was 81.5 miles. Rural residents were transferred 3 times as often as urban residents.

The good news is that PATs are rare. Only 0.8% of VHA ED visits resulted in transfer, and of those, only one-fourth were deemed potentially avoidable. And while rural veterans were more likely to be transferred, PATs were less prevalent among those transfers (20.8% vs 23.9% for urban veterans).

More than half of VHA transfers were for patients diagnosed with mental health, cardiac, and digestive conditions. The top ICD-9 diagnosis related to VHA ED transfer was suicidal ideation. The diagnostic procedures associated with most PATs were mental health (11% potentially avoidable) and cardiac (21% potentially avoidable).

Their research turned up some unexpected data: For example, smaller EDs did not have a higher prevalence of PATs, suggesting that ED size was not associated with transfer appropriateness. And the proportion of PATs was higher in hospitals with > 50% board-certified emergency physicians.

The researchers say their findings highlight important differences between the VHA health care and civilian health care systems, emphasizing that the resources available within the VHA health system “might be unique” and underlining the need for VHA-specific solutions to health care delivery challenges.

 The overall purpose of this study, the researchers say, was to identify areas where novel delivery of specialty care might reduce the need for some VHA transfers. Their analysis provides data for developing targeted intervention, such as ED-based telemedicine or “targeted remote care.”

Patients with mental health conditions—who made up more than one-third of all VHA-to-VHA interfacility transfers, higher than that reported in civilian hospitals—represent a “rich target population” for telehealth, the researchers suggest. They also note that because mental health providers are in critical shortage in most of the US, real-time telemedicine providing psychiatric resources could be an important and timely service.

Nearly half of medical directors of VHA EDs who responded to the VHA Healthcare Analysis and Information Group survey cited the transfer process as “overly burdensome,” and > 65% said administrative processes contribute to delay in transfer. Finding new ways to keep patients local could benefit providers as well.

Some veterans who present to smaller facilities, such as rural hospitals, are transferred to larger facilities for diagnostic or therapeutic procedures. But that access also can mean hardship for rural veterans by taking them far from family and adding costs. Moreover, complex care coordination can cause “triage mismatch” when the patients are at their most vulnerable: “over-triage”—transferring patients unlikely to benefit and “under-triage”—failing to transfer those likely to benefit.  

Researchers from VA Iowa City Healthcare System and University of Iowa conducted a study to find out what proportion of VHA transfers were potentially avoidable. Their study included all veterans treated in any of 120 VHA emergency departments (EDs) and transferred to a VHA acute care hospital between January 2012 and December 2014.

Potentially avoidable transfers (PATs) were defined as transfers in which the patient was either discharged from the referral ED or admitted to the referral hospital for < 24 hours, without having an invasive procedure. The researchers chose that definition to identify patients whose transfer might have been avoided if real-time specialty telemedicine were available at the index hospital. (They caution that the definition was not intended to suggest that all PATs were inappropriate.)

Over 3 years, 18,852 patients were transferred. Of the total patients transferred, 36% were transferred from 1 VHA ED to another VHA facility. Of the VHA transfers, 8,639 (46%) were transferred to another VHA ED; the rest were transferred to another VHA facility inpatient unit. The median transfer distance was 81.5 miles. Rural residents were transferred 3 times as often as urban residents.

The good news is that PATs are rare. Only 0.8% of VHA ED visits resulted in transfer, and of those, only one-fourth were deemed potentially avoidable. And while rural veterans were more likely to be transferred, PATs were less prevalent among those transfers (20.8% vs 23.9% for urban veterans).

More than half of VHA transfers were for patients diagnosed with mental health, cardiac, and digestive conditions. The top ICD-9 diagnosis related to VHA ED transfer was suicidal ideation. The diagnostic procedures associated with most PATs were mental health (11% potentially avoidable) and cardiac (21% potentially avoidable).

Their research turned up some unexpected data: For example, smaller EDs did not have a higher prevalence of PATs, suggesting that ED size was not associated with transfer appropriateness. And the proportion of PATs was higher in hospitals with > 50% board-certified emergency physicians.

The researchers say their findings highlight important differences between the VHA health care and civilian health care systems, emphasizing that the resources available within the VHA health system “might be unique” and underlining the need for VHA-specific solutions to health care delivery challenges.

 The overall purpose of this study, the researchers say, was to identify areas where novel delivery of specialty care might reduce the need for some VHA transfers. Their analysis provides data for developing targeted intervention, such as ED-based telemedicine or “targeted remote care.”

Patients with mental health conditions—who made up more than one-third of all VHA-to-VHA interfacility transfers, higher than that reported in civilian hospitals—represent a “rich target population” for telehealth, the researchers suggest. They also note that because mental health providers are in critical shortage in most of the US, real-time telemedicine providing psychiatric resources could be an important and timely service.

Nearly half of medical directors of VHA EDs who responded to the VHA Healthcare Analysis and Information Group survey cited the transfer process as “overly burdensome,” and > 65% said administrative processes contribute to delay in transfer. Finding new ways to keep patients local could benefit providers as well.

ORLANDO – For critically ill, mechanically ventilated patients, a strategy of no sedation resulted in a mortality rate that was not significantly different from a strategy of light sedation with interruption, according to results of a multicenter, randomized trial.

The lack of sedation did significantly improve certain secondary endpoints, including a reduced number of thromboembolic events and preservation of physical function, according to Palle Toft, PhD, DMSc, of Odense (Denmark) University Hospital.

However, the 90-day mortality rate was 42.4% in the no-sedation group versus 37.0% in the sedation group in the NONSEDA study, which was intended to test the hypothesis that mortality would be lower in the no-sedation group.

That 5.4 percentage point difference between arms in NONSEDA was not statistically significant (P = .65) in results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine and concurrently published in the New England Journal of Medicine.

Yet that mortality trend is in the “opposite direction” of an earlier, single-center trial by Dr. Toft and colleagues, noted Claude Guérin, MD, PhD, in a related editorial that also appeared in the journal. In that earlier study, the reported hospital mortality rates were 36% for no sedation and 47% for sedation with daily interruption.

“The results from this trial [NONSEDA] are important because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily,” Dr. Guérin wrote in his editorial.

That said, the earlier, single-center trial was not statistically powered to show between-group differences in mortality, Dr. Toft and coauthors wrote in their journal article.

In his presentation, Dr. Toft emphasized that light sedation with a wake-up trial was “comparable” with no sedation with regard to mortality.

“I think my main message is that we have to individualize patient treatment,” Dr. Toft told attendees at a late-breaking literature session. “Many patients would benefit from nonsedation, and some would benefit by light sedation with a daily wake-up trial. We have to respect patient autonomy, and try to establish a two-way communication with patients in 2020.”

Sandra L. Kane-Gill, PharmD, treasurer of SCCM and assistant professor of pharmacy and therapeutics at the University of Pittsburgh, said that current SCCM guidelines recommend using light sedation in critically ill, mechanically ventilated adults.

“I think we should stay consistent with what the guidelines are saying,” Dr. Kane-Gill said in an interview. “How you do that may vary, but targeting light sedation is consistent with what the evidence is suggesting in those guidelines.”

The depth of sedation between the no-sedation group in the light sedation group in the present study was not as great as the investigators had anticipated, which may explain the lack of statistically significant difference in mortality, according to Dr. Kane-Gill.

According to the report, 38.4% of patients in the no-sedation group received medication for sedation during their ICU stay, while Richmond Agitation and Sedation Scores increased in both groups, indicating a more alert state in both groups.

The multicenter NONSEDA trial included 700 mechanically ventilated ICU patients randomized either to no sedation or to light sedation, such that the patient was arousable, with daily interruption.

Previous studies have shown that daily interruption of sedation reduced mechanical ventilation duration, ICU stay length, and mortality in comparison with no interruption, the investigators noted.

While mortality at 90 days did not differ significantly between the no-sedation and light-sedation approaches, no sedation reduced thromboembolic events, Dr. Toft said at the meeting. The number of thrombolic events within 90 days was 10 (5%) in the sedation group and 1 (0.5%) in the no-sedation group (P less than .05), according to the reported data.

Likewise, several measures of physical function significantly improved in an a prior defined subgroup of 200 patients, he said. Those measures included hand grip at extubation and ICU discharge, as well as scores on the Barthel Index for Activities of Daily Living.

Nonsedation might improve kidney function, based on other reported outcomes of the study, Dr. Toft said. The number of coma- and delirium-free days was 3.0 in the no-sedation group versus 1.0 in the sedation group (P less than .01), he added.

The benefits of no sedation may extend beyond objective changes in health outcomes, according to Dr. Toft. “The patients are able to communicate with the staff, they might be able to enjoy food, in the evening they can look at the television instead of being sedated – and they can be mobilized and they can write their opinion about the treatments to the doctor, and in this way, you have two-way communication,” he explained in his presentation.

Dr. Toft reported that he had no financial relationships to disclose.

SOURCE: Toft P et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1906759.

ORLANDO – For critically ill, mechanically ventilated patients, a strategy of no sedation resulted in a mortality rate that was not significantly different from a strategy of light sedation with interruption, according to results of a multicenter, randomized trial.

The lack of sedation did significantly improve certain secondary endpoints, including a reduced number of thromboembolic events and preservation of physical function, according to Palle Toft, PhD, DMSc, of Odense (Denmark) University Hospital.

However, the 90-day mortality rate was 42.4% in the no-sedation group versus 37.0% in the sedation group in the NONSEDA study, which was intended to test the hypothesis that mortality would be lower in the no-sedation group.

That 5.4 percentage point difference between arms in NONSEDA was not statistically significant (P = .65) in results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine and concurrently published in the New England Journal of Medicine.

Yet that mortality trend is in the “opposite direction” of an earlier, single-center trial by Dr. Toft and colleagues, noted Claude Guérin, MD, PhD, in a related editorial that also appeared in the journal. In that earlier study, the reported hospital mortality rates were 36% for no sedation and 47% for sedation with daily interruption.

“The results from this trial [NONSEDA] are important because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily,” Dr. Guérin wrote in his editorial.

That said, the earlier, single-center trial was not statistically powered to show between-group differences in mortality, Dr. Toft and coauthors wrote in their journal article.

In his presentation, Dr. Toft emphasized that light sedation with a wake-up trial was “comparable” with no sedation with regard to mortality.

“I think my main message is that we have to individualize patient treatment,” Dr. Toft told attendees at a late-breaking literature session. “Many patients would benefit from nonsedation, and some would benefit by light sedation with a daily wake-up trial. We have to respect patient autonomy, and try to establish a two-way communication with patients in 2020.”

Sandra L. Kane-Gill, PharmD, treasurer of SCCM and assistant professor of pharmacy and therapeutics at the University of Pittsburgh, said that current SCCM guidelines recommend using light sedation in critically ill, mechanically ventilated adults.

“I think we should stay consistent with what the guidelines are saying,” Dr. Kane-Gill said in an interview. “How you do that may vary, but targeting light sedation is consistent with what the evidence is suggesting in those guidelines.”

The depth of sedation between the no-sedation group in the light sedation group in the present study was not as great as the investigators had anticipated, which may explain the lack of statistically significant difference in mortality, according to Dr. Kane-Gill.

According to the report, 38.4% of patients in the no-sedation group received medication for sedation during their ICU stay, while Richmond Agitation and Sedation Scores increased in both groups, indicating a more alert state in both groups.

The multicenter NONSEDA trial included 700 mechanically ventilated ICU patients randomized either to no sedation or to light sedation, such that the patient was arousable, with daily interruption.

Previous studies have shown that daily interruption of sedation reduced mechanical ventilation duration, ICU stay length, and mortality in comparison with no interruption, the investigators noted.

While mortality at 90 days did not differ significantly between the no-sedation and light-sedation approaches, no sedation reduced thromboembolic events, Dr. Toft said at the meeting. The number of thrombolic events within 90 days was 10 (5%) in the sedation group and 1 (0.5%) in the no-sedation group (P less than .05), according to the reported data.

Likewise, several measures of physical function significantly improved in an a prior defined subgroup of 200 patients, he said. Those measures included hand grip at extubation and ICU discharge, as well as scores on the Barthel Index for Activities of Daily Living.

Nonsedation might improve kidney function, based on other reported outcomes of the study, Dr. Toft said. The number of coma- and delirium-free days was 3.0 in the no-sedation group versus 1.0 in the sedation group (P less than .01), he added.

The benefits of no sedation may extend beyond objective changes in health outcomes, according to Dr. Toft. “The patients are able to communicate with the staff, they might be able to enjoy food, in the evening they can look at the television instead of being sedated – and they can be mobilized and they can write their opinion about the treatments to the doctor, and in this way, you have two-way communication,” he explained in his presentation.

Dr. Toft reported that he had no financial relationships to disclose.

SOURCE: Toft P et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1906759.

ORLANDO – For critically ill, mechanically ventilated patients, a strategy of no sedation resulted in a mortality rate that was not significantly different from a strategy of light sedation with interruption, according to results of a multicenter, randomized trial.

The lack of sedation did significantly improve certain secondary endpoints, including a reduced number of thromboembolic events and preservation of physical function, according to Palle Toft, PhD, DMSc, of Odense (Denmark) University Hospital.

However, the 90-day mortality rate was 42.4% in the no-sedation group versus 37.0% in the sedation group in the NONSEDA study, which was intended to test the hypothesis that mortality would be lower in the no-sedation group.

That 5.4 percentage point difference between arms in NONSEDA was not statistically significant (P = .65) in results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine and concurrently published in the New England Journal of Medicine.

Yet that mortality trend is in the “opposite direction” of an earlier, single-center trial by Dr. Toft and colleagues, noted Claude Guérin, MD, PhD, in a related editorial that also appeared in the journal. In that earlier study, the reported hospital mortality rates were 36% for no sedation and 47% for sedation with daily interruption.

“The results from this trial [NONSEDA] are important because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily,” Dr. Guérin wrote in his editorial.

That said, the earlier, single-center trial was not statistically powered to show between-group differences in mortality, Dr. Toft and coauthors wrote in their journal article.

In his presentation, Dr. Toft emphasized that light sedation with a wake-up trial was “comparable” with no sedation with regard to mortality.

“I think my main message is that we have to individualize patient treatment,” Dr. Toft told attendees at a late-breaking literature session. “Many patients would benefit from nonsedation, and some would benefit by light sedation with a daily wake-up trial. We have to respect patient autonomy, and try to establish a two-way communication with patients in 2020.”

Sandra L. Kane-Gill, PharmD, treasurer of SCCM and assistant professor of pharmacy and therapeutics at the University of Pittsburgh, said that current SCCM guidelines recommend using light sedation in critically ill, mechanically ventilated adults.

“I think we should stay consistent with what the guidelines are saying,” Dr. Kane-Gill said in an interview. “How you do that may vary, but targeting light sedation is consistent with what the evidence is suggesting in those guidelines.”

The depth of sedation between the no-sedation group in the light sedation group in the present study was not as great as the investigators had anticipated, which may explain the lack of statistically significant difference in mortality, according to Dr. Kane-Gill.

According to the report, 38.4% of patients in the no-sedation group received medication for sedation during their ICU stay, while Richmond Agitation and Sedation Scores increased in both groups, indicating a more alert state in both groups.

The multicenter NONSEDA trial included 700 mechanically ventilated ICU patients randomized either to no sedation or to light sedation, such that the patient was arousable, with daily interruption.

Previous studies have shown that daily interruption of sedation reduced mechanical ventilation duration, ICU stay length, and mortality in comparison with no interruption, the investigators noted.

While mortality at 90 days did not differ significantly between the no-sedation and light-sedation approaches, no sedation reduced thromboembolic events, Dr. Toft said at the meeting. The number of thrombolic events within 90 days was 10 (5%) in the sedation group and 1 (0.5%) in the no-sedation group (P less than .05), according to the reported data.

Likewise, several measures of physical function significantly improved in an a prior defined subgroup of 200 patients, he said. Those measures included hand grip at extubation and ICU discharge, as well as scores on the Barthel Index for Activities of Daily Living.

Nonsedation might improve kidney function, based on other reported outcomes of the study, Dr. Toft said. The number of coma- and delirium-free days was 3.0 in the no-sedation group versus 1.0 in the sedation group (P less than .01), he added.

The benefits of no sedation may extend beyond objective changes in health outcomes, according to Dr. Toft. “The patients are able to communicate with the staff, they might be able to enjoy food, in the evening they can look at the television instead of being sedated – and they can be mobilized and they can write their opinion about the treatments to the doctor, and in this way, you have two-way communication,” he explained in his presentation.

Dr. Toft reported that he had no financial relationships to disclose.

SOURCE: Toft P et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1906759.

WEST PALM BEACH, FLA. – Failure to recover completely from early relapses in multiple sclerosis (MS) is significantly associated with higher long-term disability, according to research presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Incomplete recovery thus should be given more consideration when evaluating research and clinical practice outcomes, the study investigators cautioned.

“We found that the recovery from early relapses is an important predictor of future disability,” first author Marinos G. Sotiropoulos, MD, of the department of neurology, Brigham and Women’s Hospital, Boston, said in an interview. “It should be incorporated in future predictive models of disease severity and clinical trials, [and] it could be useful in clinical decision making as well.”

Incomplete recovery from relapses is known to be linked to disability progression and to the likelihood of transitioning to secondary progressive MS. Research on its role in longer-term outcomes is lacking, however.

To investigate the effect of incomplete relapse recovery in the first 3 years of MS on rates of disability at 10 years, Dr. Sotiropoulos and colleagues evaluated data on 360 patients enrolled in the CLIMB (Comprehensive Longitudinal Investigation in Multiple Sclerosis at Brigham and Women’s Hospital) study. CLIMB is a natural history study spanning 20 years, with more than 2,000 patients.

Patients were included if at least 8.5 years had passed since their first documented symptom, if they were at least 18 years at their first visit to the Partners MS Center, if that visit occurred within 1 year of their first symptom, and if they had a diagnosis of relapsing-remitting MS or secondary progressive MS.

Among the 308 patients included in the study, 74% were female and 89% were white, with a mean age at the first symptom of 35.9 years.

A total of 403 early attacks from those 308 patients were included in the study. Half of the attacks (50.4%) were followed by incomplete recovery after 6 months, defined specifically as an increase in the Expanded Disability Status Scale (EDSS) scores from baseline to at least 6 months after the onset of the attack.

As of their 10-year visit, 27.3% of patients had a normal examination, defined as EDSS 0, and 64.1% had no significant disability (EDSS less than 2). The mean EDSS at 10 years was 1.52.

Patients’ recovery index, defined as the percentage of early attacks that recovered completely, was significantly associated with 10-year EDSS scores (P less than .001).

Patient age at first symptom was also a significant predictor of 10-year disability (P less than .004). Factors that were significantly associated with incomplete relapse recovery were the duration of time from first symptom (P less than .001) and moderate severity of the relapse (P = .029).

With the type of drug treatment likely representing an important factor in whether a patient has incomplete relapse recovery, the issue should be the subject of further research, Dr. Sotiropoulos said.

“This is something that is important to look at because none of the clinical trials for the drugs we currently have looked at relapse recovery as an outcome,” he explained.

“There have been some post hoc analyses [that] have shown that some of the new medications can improve recovery from relapses, but there is a lot to look into now that we know relapse recovery is an important clinical parameter,” he said. “We have to factor in the treatment effect in preventing residual disability after relapses.”

The findings suggest that “patients with incomplete early recovery might be considered for highly effective disease-modifying therapy,” added senior author Tanuja Chitnis, MD, also of the department of neurology at Brigham and Women’s Hospital. “We are now analyzing the biological mechanisms associated with relapse recovery.”

The authors of a recent study that echoes the importance of relapse recovery call it “the forgotten variable in multiple sclerosis clinical trials.” In that study, the researchers found an increased likelihood of a benign disease course among patients who received immediate disease-modifying therapy (DMT) initiation after failing to have a good recovery from an initial relapse (Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17;7[2]).

“Some clinicians may choose to hold off DMTs because the patient may not have high disease activity levels,” Burcu Zeydan, MD, a coauthor of that study and an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic, Rochester, Minn., said in an interview.

“What these studies add is that, if a patient is a poor recoverer despite not having highly active disease, that patient should be considered for immediate treatment initiation,” she said. “Otherwise, there is the possibility of a next relapse, which may not happen often. But when it happens, it may lead to more residual deficit with additional disability burden.”

The CLIMB study received funding from Mallinckrodt and the National MS Society Nancy Davis Center Without Walls. Dr. Sotiropoulos has received research support from Mallinckrodt. Dr. Chitnis has served on advisory boards for Biogen, Novartis, and Sanofi-Genzyme, and she has received research support from the Department of Defense, National MS Society, Guthy-Jackson Charitable Foundation, Novartis, Octave, Serono, and Verily. Dr. Zeydan had no disclosures to report.

SOURCE: Sotiropoulos MG et al. ACTRIMS Forum 2020. Abstract LB 317.

WEST PALM BEACH, FLA. – Failure to recover completely from early relapses in multiple sclerosis (MS) is significantly associated with higher long-term disability, according to research presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Incomplete recovery thus should be given more consideration when evaluating research and clinical practice outcomes, the study investigators cautioned.

“We found that the recovery from early relapses is an important predictor of future disability,” first author Marinos G. Sotiropoulos, MD, of the department of neurology, Brigham and Women’s Hospital, Boston, said in an interview. “It should be incorporated in future predictive models of disease severity and clinical trials, [and] it could be useful in clinical decision making as well.”

Incomplete recovery from relapses is known to be linked to disability progression and to the likelihood of transitioning to secondary progressive MS. Research on its role in longer-term outcomes is lacking, however.

To investigate the effect of incomplete relapse recovery in the first 3 years of MS on rates of disability at 10 years, Dr. Sotiropoulos and colleagues evaluated data on 360 patients enrolled in the CLIMB (Comprehensive Longitudinal Investigation in Multiple Sclerosis at Brigham and Women’s Hospital) study. CLIMB is a natural history study spanning 20 years, with more than 2,000 patients.

Patients were included if at least 8.5 years had passed since their first documented symptom, if they were at least 18 years at their first visit to the Partners MS Center, if that visit occurred within 1 year of their first symptom, and if they had a diagnosis of relapsing-remitting MS or secondary progressive MS.

Among the 308 patients included in the study, 74% were female and 89% were white, with a mean age at the first symptom of 35.9 years.

A total of 403 early attacks from those 308 patients were included in the study. Half of the attacks (50.4%) were followed by incomplete recovery after 6 months, defined specifically as an increase in the Expanded Disability Status Scale (EDSS) scores from baseline to at least 6 months after the onset of the attack.

As of their 10-year visit, 27.3% of patients had a normal examination, defined as EDSS 0, and 64.1% had no significant disability (EDSS less than 2). The mean EDSS at 10 years was 1.52.

Patients’ recovery index, defined as the percentage of early attacks that recovered completely, was significantly associated with 10-year EDSS scores (P less than .001).

Patient age at first symptom was also a significant predictor of 10-year disability (P less than .004). Factors that were significantly associated with incomplete relapse recovery were the duration of time from first symptom (P less than .001) and moderate severity of the relapse (P = .029).

With the type of drug treatment likely representing an important factor in whether a patient has incomplete relapse recovery, the issue should be the subject of further research, Dr. Sotiropoulos said.

“This is something that is important to look at because none of the clinical trials for the drugs we currently have looked at relapse recovery as an outcome,” he explained.

“There have been some post hoc analyses [that] have shown that some of the new medications can improve recovery from relapses, but there is a lot to look into now that we know relapse recovery is an important clinical parameter,” he said. “We have to factor in the treatment effect in preventing residual disability after relapses.”

The findings suggest that “patients with incomplete early recovery might be considered for highly effective disease-modifying therapy,” added senior author Tanuja Chitnis, MD, also of the department of neurology at Brigham and Women’s Hospital. “We are now analyzing the biological mechanisms associated with relapse recovery.”

The authors of a recent study that echoes the importance of relapse recovery call it “the forgotten variable in multiple sclerosis clinical trials.” In that study, the researchers found an increased likelihood of a benign disease course among patients who received immediate disease-modifying therapy (DMT) initiation after failing to have a good recovery from an initial relapse (Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17;7[2]).

“Some clinicians may choose to hold off DMTs because the patient may not have high disease activity levels,” Burcu Zeydan, MD, a coauthor of that study and an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic, Rochester, Minn., said in an interview.

“What these studies add is that, if a patient is a poor recoverer despite not having highly active disease, that patient should be considered for immediate treatment initiation,” she said. “Otherwise, there is the possibility of a next relapse, which may not happen often. But when it happens, it may lead to more residual deficit with additional disability burden.”

The CLIMB study received funding from Mallinckrodt and the National MS Society Nancy Davis Center Without Walls. Dr. Sotiropoulos has received research support from Mallinckrodt. Dr. Chitnis has served on advisory boards for Biogen, Novartis, and Sanofi-Genzyme, and she has received research support from the Department of Defense, National MS Society, Guthy-Jackson Charitable Foundation, Novartis, Octave, Serono, and Verily. Dr. Zeydan had no disclosures to report.

SOURCE: Sotiropoulos MG et al. ACTRIMS Forum 2020. Abstract LB 317.

WEST PALM BEACH, FLA. – Failure to recover completely from early relapses in multiple sclerosis (MS) is significantly associated with higher long-term disability, according to research presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Incomplete recovery thus should be given more consideration when evaluating research and clinical practice outcomes, the study investigators cautioned.

“We found that the recovery from early relapses is an important predictor of future disability,” first author Marinos G. Sotiropoulos, MD, of the department of neurology, Brigham and Women’s Hospital, Boston, said in an interview. “It should be incorporated in future predictive models of disease severity and clinical trials, [and] it could be useful in clinical decision making as well.”

Incomplete recovery from relapses is known to be linked to disability progression and to the likelihood of transitioning to secondary progressive MS. Research on its role in longer-term outcomes is lacking, however.

To investigate the effect of incomplete relapse recovery in the first 3 years of MS on rates of disability at 10 years, Dr. Sotiropoulos and colleagues evaluated data on 360 patients enrolled in the CLIMB (Comprehensive Longitudinal Investigation in Multiple Sclerosis at Brigham and Women’s Hospital) study. CLIMB is a natural history study spanning 20 years, with more than 2,000 patients.

Patients were included if at least 8.5 years had passed since their first documented symptom, if they were at least 18 years at their first visit to the Partners MS Center, if that visit occurred within 1 year of their first symptom, and if they had a diagnosis of relapsing-remitting MS or secondary progressive MS.

Among the 308 patients included in the study, 74% were female and 89% were white, with a mean age at the first symptom of 35.9 years.

A total of 403 early attacks from those 308 patients were included in the study. Half of the attacks (50.4%) were followed by incomplete recovery after 6 months, defined specifically as an increase in the Expanded Disability Status Scale (EDSS) scores from baseline to at least 6 months after the onset of the attack.

As of their 10-year visit, 27.3% of patients had a normal examination, defined as EDSS 0, and 64.1% had no significant disability (EDSS less than 2). The mean EDSS at 10 years was 1.52.

Patients’ recovery index, defined as the percentage of early attacks that recovered completely, was significantly associated with 10-year EDSS scores (P less than .001).

Patient age at first symptom was also a significant predictor of 10-year disability (P less than .004). Factors that were significantly associated with incomplete relapse recovery were the duration of time from first symptom (P less than .001) and moderate severity of the relapse (P = .029).

With the type of drug treatment likely representing an important factor in whether a patient has incomplete relapse recovery, the issue should be the subject of further research, Dr. Sotiropoulos said.

“This is something that is important to look at because none of the clinical trials for the drugs we currently have looked at relapse recovery as an outcome,” he explained.

“There have been some post hoc analyses [that] have shown that some of the new medications can improve recovery from relapses, but there is a lot to look into now that we know relapse recovery is an important clinical parameter,” he said. “We have to factor in the treatment effect in preventing residual disability after relapses.”

The findings suggest that “patients with incomplete early recovery might be considered for highly effective disease-modifying therapy,” added senior author Tanuja Chitnis, MD, also of the department of neurology at Brigham and Women’s Hospital. “We are now analyzing the biological mechanisms associated with relapse recovery.”

The authors of a recent study that echoes the importance of relapse recovery call it “the forgotten variable in multiple sclerosis clinical trials.” In that study, the researchers found an increased likelihood of a benign disease course among patients who received immediate disease-modifying therapy (DMT) initiation after failing to have a good recovery from an initial relapse (Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17;7[2]).

“Some clinicians may choose to hold off DMTs because the patient may not have high disease activity levels,” Burcu Zeydan, MD, a coauthor of that study and an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic, Rochester, Minn., said in an interview.

“What these studies add is that, if a patient is a poor recoverer despite not having highly active disease, that patient should be considered for immediate treatment initiation,” she said. “Otherwise, there is the possibility of a next relapse, which may not happen often. But when it happens, it may lead to more residual deficit with additional disability burden.”

The CLIMB study received funding from Mallinckrodt and the National MS Society Nancy Davis Center Without Walls. Dr. Sotiropoulos has received research support from Mallinckrodt. Dr. Chitnis has served on advisory boards for Biogen, Novartis, and Sanofi-Genzyme, and she has received research support from the Department of Defense, National MS Society, Guthy-Jackson Charitable Foundation, Novartis, Octave, Serono, and Verily. Dr. Zeydan had no disclosures to report.

SOURCE: Sotiropoulos MG et al. ACTRIMS Forum 2020. Abstract LB 317.

In a telebriefing on the COVID-19 outbreak, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention announced that the agency has updated the definition of “Person Under Investigation,” or PUI, for the disease.

The definition has been revised “to meet the needs of this rapidly evolving situation,” she said. The new PUI definition includes travel to more geographic areas to reflect this past week’s marked uptick in coronavirus activity in Italy and Iran. In addition to these countries and China, recent travel to Japan or South Korea also constitutes an epidemiologic risk factor which, in conjunction with clinical features, warrant an individual being classified as a PUI. These five countries each now have widespread person-to-person transmission of the virus.

Dr. Messonnier left open the possibility that the PUI definition would continue to evolve if such transmission within communities becomes more common. Asked whether the small number of U.S. cases thus might be an artifact of low test volumes, she said, “We aggressively controlled our borders to slow the spread. This was an intentional U.S. strategy. The CDC has always had the capacity to test rapidly from the time the sequence was available. ...We have been testing aggressively.”

The original PUI definition, she explained, emphasized individuals with fever, cough, or trouble breathing who had traveled recently from areas with COVID-19 activity, in particular China’s Hubei province. “We have been most focused on symptomatic people who are closely linked to, or who had, travel history, but our criteria also allow for clinical discretion,” she said. “There is no substitute for an astute clinician on the front lines of patient care.”

The first COVID-19 case from person-to-person spread was reported on Feb. 27. “At this time, we don’t know how or where this person became infected,” said Dr. Messonnier, although investigations are still underway. She responded to a question about whether the CDC delayed allowing COVID-19 testing for the patient for several days, as was reported in some media accounts. “According to CDC records, the first call we got was Feb. 23,” when public health officials in California reported a severely ill person with no travel abroad and no known contacts with individuals that would trigger suspicions for coronavirus. The CDC recommended COVID-19 testing on that day, she said.

Dr. Messonnier declined to answer questions about a whistleblower report alleging improper training and inadequate protective measures for Department of Health & Human Services workers at the quarantine center at Travis Air Force Base, Calif.

Dr. Messonnier said that the CDC has been working closely with the Food and Drug Administration to address problems with the COVID-19 test kits that were unusable because of a large number of indeterminate results. The two agencies together have determined that of the three reactions that were initially deemed necessary for a definitive COVID-19 diagnosis, just two are sufficient, so new kits that omit the problematic chemical are being manufactured and distributed.

These new kits are rapidly being made available; the goal, said Dr. Messonnier, is to have to state and local public health departments equipped with test kits by about March 7.

As local tests become available, the most updated information will be coming from state and local public health departments, she stressed, adding that the CDC would continue to update case counts on Monday, Wednesday, and Friday of each week. Procedures are being developed for the management of patients presumed to have COVID-19, where local health departments see positive tests but the mandatory CDC confirmatory test hasn’t been completed.

While new cases emerge across Europe and Asia, China’s earlier COVID-19 explosion seems to be slowing. “It’s really good news that the case counts in China are decreasing,” both for the well-being of that country’s citizens, and as a sign of the disease’s potential global effects, said Dr. Messonnier. She added that epidemiologists and mathematical modelers are parsing case fatality rates as well.

She advised health care providers and public health officials to keep abreast of changes in CDC guidance by checking frequently at https://www.cdc.gov/coronavirus/2019-ncov/index.html.

koakes@mdedge.com

In a telebriefing on the COVID-19 outbreak, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention announced that the agency has updated the definition of “Person Under Investigation,” or PUI, for the disease.

The definition has been revised “to meet the needs of this rapidly evolving situation,” she said. The new PUI definition includes travel to more geographic areas to reflect this past week’s marked uptick in coronavirus activity in Italy and Iran. In addition to these countries and China, recent travel to Japan or South Korea also constitutes an epidemiologic risk factor which, in conjunction with clinical features, warrant an individual being classified as a PUI. These five countries each now have widespread person-to-person transmission of the virus.

Dr. Messonnier left open the possibility that the PUI definition would continue to evolve if such transmission within communities becomes more common. Asked whether the small number of U.S. cases thus might be an artifact of low test volumes, she said, “We aggressively controlled our borders to slow the spread. This was an intentional U.S. strategy. The CDC has always had the capacity to test rapidly from the time the sequence was available. ...We have been testing aggressively.”

The original PUI definition, she explained, emphasized individuals with fever, cough, or trouble breathing who had traveled recently from areas with COVID-19 activity, in particular China’s Hubei province. “We have been most focused on symptomatic people who are closely linked to, or who had, travel history, but our criteria also allow for clinical discretion,” she said. “There is no substitute for an astute clinician on the front lines of patient care.”

The first COVID-19 case from person-to-person spread was reported on Feb. 27. “At this time, we don’t know how or where this person became infected,” said Dr. Messonnier, although investigations are still underway. She responded to a question about whether the CDC delayed allowing COVID-19 testing for the patient for several days, as was reported in some media accounts. “According to CDC records, the first call we got was Feb. 23,” when public health officials in California reported a severely ill person with no travel abroad and no known contacts with individuals that would trigger suspicions for coronavirus. The CDC recommended COVID-19 testing on that day, she said.

Dr. Messonnier declined to answer questions about a whistleblower report alleging improper training and inadequate protective measures for Department of Health & Human Services workers at the quarantine center at Travis Air Force Base, Calif.

Dr. Messonnier said that the CDC has been working closely with the Food and Drug Administration to address problems with the COVID-19 test kits that were unusable because of a large number of indeterminate results. The two agencies together have determined that of the three reactions that were initially deemed necessary for a definitive COVID-19 diagnosis, just two are sufficient, so new kits that omit the problematic chemical are being manufactured and distributed.

These new kits are rapidly being made available; the goal, said Dr. Messonnier, is to have to state and local public health departments equipped with test kits by about March 7.

As local tests become available, the most updated information will be coming from state and local public health departments, she stressed, adding that the CDC would continue to update case counts on Monday, Wednesday, and Friday of each week. Procedures are being developed for the management of patients presumed to have COVID-19, where local health departments see positive tests but the mandatory CDC confirmatory test hasn’t been completed.

While new cases emerge across Europe and Asia, China’s earlier COVID-19 explosion seems to be slowing. “It’s really good news that the case counts in China are decreasing,” both for the well-being of that country’s citizens, and as a sign of the disease’s potential global effects, said Dr. Messonnier. She added that epidemiologists and mathematical modelers are parsing case fatality rates as well.

She advised health care providers and public health officials to keep abreast of changes in CDC guidance by checking frequently at https://www.cdc.gov/coronavirus/2019-ncov/index.html.

koakes@mdedge.com

In a telebriefing on the COVID-19 outbreak, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention announced that the agency has updated the definition of “Person Under Investigation,” or PUI, for the disease.

The definition has been revised “to meet the needs of this rapidly evolving situation,” she said. The new PUI definition includes travel to more geographic areas to reflect this past week’s marked uptick in coronavirus activity in Italy and Iran. In addition to these countries and China, recent travel to Japan or South Korea also constitutes an epidemiologic risk factor which, in conjunction with clinical features, warrant an individual being classified as a PUI. These five countries each now have widespread person-to-person transmission of the virus.

Dr. Messonnier left open the possibility that the PUI definition would continue to evolve if such transmission within communities becomes more common. Asked whether the small number of U.S. cases thus might be an artifact of low test volumes, she said, “We aggressively controlled our borders to slow the spread. This was an intentional U.S. strategy. The CDC has always had the capacity to test rapidly from the time the sequence was available. ...We have been testing aggressively.”

The original PUI definition, she explained, emphasized individuals with fever, cough, or trouble breathing who had traveled recently from areas with COVID-19 activity, in particular China’s Hubei province. “We have been most focused on symptomatic people who are closely linked to, or who had, travel history, but our criteria also allow for clinical discretion,” she said. “There is no substitute for an astute clinician on the front lines of patient care.”

The first COVID-19 case from person-to-person spread was reported on Feb. 27. “At this time, we don’t know how or where this person became infected,” said Dr. Messonnier, although investigations are still underway. She responded to a question about whether the CDC delayed allowing COVID-19 testing for the patient for several days, as was reported in some media accounts. “According to CDC records, the first call we got was Feb. 23,” when public health officials in California reported a severely ill person with no travel abroad and no known contacts with individuals that would trigger suspicions for coronavirus. The CDC recommended COVID-19 testing on that day, she said.

Dr. Messonnier declined to answer questions about a whistleblower report alleging improper training and inadequate protective measures for Department of Health & Human Services workers at the quarantine center at Travis Air Force Base, Calif.

Dr. Messonnier said that the CDC has been working closely with the Food and Drug Administration to address problems with the COVID-19 test kits that were unusable because of a large number of indeterminate results. The two agencies together have determined that of the three reactions that were initially deemed necessary for a definitive COVID-19 diagnosis, just two are sufficient, so new kits that omit the problematic chemical are being manufactured and distributed.

These new kits are rapidly being made available; the goal, said Dr. Messonnier, is to have to state and local public health departments equipped with test kits by about March 7.

As local tests become available, the most updated information will be coming from state and local public health departments, she stressed, adding that the CDC would continue to update case counts on Monday, Wednesday, and Friday of each week. Procedures are being developed for the management of patients presumed to have COVID-19, where local health departments see positive tests but the mandatory CDC confirmatory test hasn’t been completed.

While new cases emerge across Europe and Asia, China’s earlier COVID-19 explosion seems to be slowing. “It’s really good news that the case counts in China are decreasing,” both for the well-being of that country’s citizens, and as a sign of the disease’s potential global effects, said Dr. Messonnier. She added that epidemiologists and mathematical modelers are parsing case fatality rates as well.

She advised health care providers and public health officials to keep abreast of changes in CDC guidance by checking frequently at https://www.cdc.gov/coronavirus/2019-ncov/index.html.

koakes@mdedge.com

The VA has released an updated list of locations outside of Vietnam where tactical herbicides have been used, tested, or stored by the US military. The list, which includes the “rainbow” herbicides (Agents Orange, Pink, Green, Purple, Blue, and White), comes from the DoD, after a “thorough review” of research, reports, and government publications in response to a November 2018 US Government Accountability Office (GAO) report.

The GAO made 6 recommendations, including that the DoD develop a process for updating the list, and that the DoD and the VA develop a process for coordinating the communication of the information. The DoD concurred with 4 recommendations.

The VA, responding to the GAO report, said it was “concerned that the report conflates the terms commercial herbicides with tactical herbicides, which are distinct from one another.” Certain testing and storage locations (eg, Kelly Air Force Base), it noted, are added to the list based on the presence of commercial herbicides or “mere components” of Agent Orange or other rainbow agents.

The distinction is important for veterans applying for disability benefits. The impetus for creating the list of testing and storage sites, the VA says, was to carry out the administration of providing disability benefits in accordance with the applicable Agent Orange statute and regulations. Exposure to tactical herbicides (herbicides intended for military operations in Vietnam) is required for the VA to grant benefits on a presumptive basis for Agent Orange conditions outside of Vietnam. Thus, the VA concludes in its response, unless the commercial herbicides were the “same composition, forms, and mixtures” as the estimated 20 million gallons of rainbow agents specifically produced for operations in Vietnam, the “discussion is misleading.”

The VA also did not concur with the recommendation that it take the lead on developing “clear and transparent criteria” for what constitutes a location to be included on the list.

The DoD and VA did agree with the recommendation that the DoD should be the lead agency for producing and updating the list, while the VA will be the lead agency in providing information to veterans. The list will be updated as verifiable information becomes available, said Defense Secretary Mark Esper.

The full list of locations is available at https://www.publichealth.va.gov/docs/agentorange/dod_herbicides_outside_vietnam.pdf.
The GAO report is available at https://www.gao.gov/assets/gao-19-24.pdf.

The VA has released an updated list of locations outside of Vietnam where tactical herbicides have been used, tested, or stored by the US military. The list, which includes the “rainbow” herbicides (Agents Orange, Pink, Green, Purple, Blue, and White), comes from the DoD, after a “thorough review” of research, reports, and government publications in response to a November 2018 US Government Accountability Office (GAO) report.

The GAO made 6 recommendations, including that the DoD develop a process for updating the list, and that the DoD and the VA develop a process for coordinating the communication of the information. The DoD concurred with 4 recommendations.

The VA, responding to the GAO report, said it was “concerned that the report conflates the terms commercial herbicides with tactical herbicides, which are distinct from one another.” Certain testing and storage locations (eg, Kelly Air Force Base), it noted, are added to the list based on the presence of commercial herbicides or “mere components” of Agent Orange or other rainbow agents.

The distinction is important for veterans applying for disability benefits. The impetus for creating the list of testing and storage sites, the VA says, was to carry out the administration of providing disability benefits in accordance with the applicable Agent Orange statute and regulations. Exposure to tactical herbicides (herbicides intended for military operations in Vietnam) is required for the VA to grant benefits on a presumptive basis for Agent Orange conditions outside of Vietnam. Thus, the VA concludes in its response, unless the commercial herbicides were the “same composition, forms, and mixtures” as the estimated 20 million gallons of rainbow agents specifically produced for operations in Vietnam, the “discussion is misleading.”

The VA also did not concur with the recommendation that it take the lead on developing “clear and transparent criteria” for what constitutes a location to be included on the list.

The DoD and VA did agree with the recommendation that the DoD should be the lead agency for producing and updating the list, while the VA will be the lead agency in providing information to veterans. The list will be updated as verifiable information becomes available, said Defense Secretary Mark Esper.

The full list of locations is available at https://www.publichealth.va.gov/docs/agentorange/dod_herbicides_outside_vietnam.pdf.
The GAO report is available at https://www.gao.gov/assets/gao-19-24.pdf.

The VA has released an updated list of locations outside of Vietnam where tactical herbicides have been used, tested, or stored by the US military. The list, which includes the “rainbow” herbicides (Agents Orange, Pink, Green, Purple, Blue, and White), comes from the DoD, after a “thorough review” of research, reports, and government publications in response to a November 2018 US Government Accountability Office (GAO) report.

The GAO made 6 recommendations, including that the DoD develop a process for updating the list, and that the DoD and the VA develop a process for coordinating the communication of the information. The DoD concurred with 4 recommendations.

The VA, responding to the GAO report, said it was “concerned that the report conflates the terms commercial herbicides with tactical herbicides, which are distinct from one another.” Certain testing and storage locations (eg, Kelly Air Force Base), it noted, are added to the list based on the presence of commercial herbicides or “mere components” of Agent Orange or other rainbow agents.

The distinction is important for veterans applying for disability benefits. The impetus for creating the list of testing and storage sites, the VA says, was to carry out the administration of providing disability benefits in accordance with the applicable Agent Orange statute and regulations. Exposure to tactical herbicides (herbicides intended for military operations in Vietnam) is required for the VA to grant benefits on a presumptive basis for Agent Orange conditions outside of Vietnam. Thus, the VA concludes in its response, unless the commercial herbicides were the “same composition, forms, and mixtures” as the estimated 20 million gallons of rainbow agents specifically produced for operations in Vietnam, the “discussion is misleading.”

The VA also did not concur with the recommendation that it take the lead on developing “clear and transparent criteria” for what constitutes a location to be included on the list.

The DoD and VA did agree with the recommendation that the DoD should be the lead agency for producing and updating the list, while the VA will be the lead agency in providing information to veterans. The list will be updated as verifiable information becomes available, said Defense Secretary Mark Esper.

The full list of locations is available at https://www.publichealth.va.gov/docs/agentorange/dod_herbicides_outside_vietnam.pdf.
The GAO report is available at https://www.gao.gov/assets/gao-19-24.pdf.

National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.

MDedge News

Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.

Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.

ILI-related deaths among children, however, are not dropping. There were 20 pediatric deaths reported during the week, more than any other single week this season. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”

rfranki@mdedge.com

National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.

MDedge News

Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.

Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.

ILI-related deaths among children, however, are not dropping. There were 20 pediatric deaths reported during the week, more than any other single week this season. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”

rfranki@mdedge.com

National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.

MDedge News

Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.

Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.

ILI-related deaths among children, however, are not dropping. There were 20 pediatric deaths reported during the week, more than any other single week this season. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”

rfranki@mdedge.com

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

gtwachtman@mdedge.com

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

gtwachtman@mdedge.com

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

gtwachtman@mdedge.com

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first generic version of Teva’s ProAir HFA (albuterol sulfate inhalation aerosol).

Generic albuterol sulfate inhalation, from Perrigo Pharmaceutical, is indicated for the treatment or prevention of bronchospasm in people aged 4 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm.

“Approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our long-standing commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen Hahn, MD, said in a news release.

Metered-dose inhalers are hard to duplicate because of the complexities of their formulation or mode of delivery. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” he explained.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn added.

In the United States, more than 26 million people suffer from asthma; about 7 million of these people are children.

Perrigo said it will immediately launch a limited quantity of generic albuterol sulfate and, in collaboration with its development and manufacturing partner, Catalent Pharma Solutions, is ramping up production to meet future demand.

The company “anticipates that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” Perrigo Executive Vice President and Rx Pharmaceuticals President Sharon Kochan said in a statement.

This article originally appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first generic version of Teva’s ProAir HFA (albuterol sulfate inhalation aerosol).

Generic albuterol sulfate inhalation, from Perrigo Pharmaceutical, is indicated for the treatment or prevention of bronchospasm in people aged 4 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm.

“Approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our long-standing commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen Hahn, MD, said in a news release.

Metered-dose inhalers are hard to duplicate because of the complexities of their formulation or mode of delivery. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” he explained.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn added.

In the United States, more than 26 million people suffer from asthma; about 7 million of these people are children.

Perrigo said it will immediately launch a limited quantity of generic albuterol sulfate and, in collaboration with its development and manufacturing partner, Catalent Pharma Solutions, is ramping up production to meet future demand.

The company “anticipates that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” Perrigo Executive Vice President and Rx Pharmaceuticals President Sharon Kochan said in a statement.

This article originally appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first generic version of Teva’s ProAir HFA (albuterol sulfate inhalation aerosol).

Generic albuterol sulfate inhalation, from Perrigo Pharmaceutical, is indicated for the treatment or prevention of bronchospasm in people aged 4 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm.

“Approval of the first generic drug product for one of the most commonly used rescue inhalers in the US is part of our long-standing commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen Hahn, MD, said in a news release.

Metered-dose inhalers are hard to duplicate because of the complexities of their formulation or mode of delivery. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” he explained.

“Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn added.

In the United States, more than 26 million people suffer from asthma; about 7 million of these people are children.

Perrigo said it will immediately launch a limited quantity of generic albuterol sulfate and, in collaboration with its development and manufacturing partner, Catalent Pharma Solutions, is ramping up production to meet future demand.

The company “anticipates that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020,” Perrigo Executive Vice President and Rx Pharmaceuticals President Sharon Kochan said in a statement.

This article originally appeared on Medscape.com.