Clinical question

Does decreased length of stay result in increased risk of 30-day readmission for hospitalized patients with acute medical illness?

Bottom line

Reduction in length of stay (LOS) is not associated with increased risk of 30-day readmission for patients with acute medical illness. Although this may suggest that decreased LOS does not affect quality of care, this finding may also be due to improved efficiencies in a previously inefficient Veteran Affairs (VA) system leading to earlier discharges and increased efforts at bettering transitions of care. LOE = 2b

Reference

Kaboli PJ, Go JT, Hockenberry J, et al. Associations between reduced hospital length of stay and 30-day readmission rate and mortality: 14-year experience in 129 Veterans Affairs hospitals. Ann Intern Med 2012;157(12):837-845.

Study design

Cohort (retrospective)

Funding source

Government

Allocation

Uncertain

Setting

Inpatient (any location)

Synopsis

To determine whether reductions in LOS adversely affect 30-day readmission rates, these investigators used a national VA administrative database to identify all acute medical admissions to VA hospitals from 1997 to 2010. Patients who died, were transferred to another acute care facility, or whose LOS was longer than 30 days were excluded from consideration. Readmissions were defined as those that were linked to the index admission and occurred within 30 days of discharge. The cohort consisted of more than 4 million admissions and was further subdivided into 5 high-volume diagnoses: heart failure, chronic obstructive pulmonary disease (COPD), heart failure, acute myocardial infarction (AMI), community-acquired pneumonia, and gastrointestinal bleed. After adjusting for hospital and patient characteristics, LOS decreased during the 14-year period from 5.44 days to 3.98 days, and 30-day readmission rates decreased from 16.5% to 13.8%. Among the 5 high-volume conditions, LOS decreased the most for AMI (by almost 3 days) while readmission rates decreased the most for COPD (3.3%). Further analysis of all medical conditions showed that each additional day of stay resulted in a 3% increased rate of readmission. This was likely due to unmeasured severity of illness that affected both LOS and readmission. Of note, however, hospitals that had a mean LOS lower than the average LOS across all hospitals had higher readmissions rates (6% increase for each day lower than the average). Despite this, the overall readmission rate decreased over time as LOS decreased. All-cause mortality at 30 days and 90 days also improved over time.

Clinical question

Does decreased length of stay result in increased risk of 30-day readmission for hospitalized patients with acute medical illness?

Bottom line

Reduction in length of stay (LOS) is not associated with increased risk of 30-day readmission for patients with acute medical illness. Although this may suggest that decreased LOS does not affect quality of care, this finding may also be due to improved efficiencies in a previously inefficient Veteran Affairs (VA) system leading to earlier discharges and increased efforts at bettering transitions of care. LOE = 2b

Reference

Kaboli PJ, Go JT, Hockenberry J, et al. Associations between reduced hospital length of stay and 30-day readmission rate and mortality: 14-year experience in 129 Veterans Affairs hospitals. Ann Intern Med 2012;157(12):837-845.

Study design

Cohort (retrospective)

Funding source

Government

Allocation

Uncertain

Setting

Inpatient (any location)

Synopsis

To determine whether reductions in LOS adversely affect 30-day readmission rates, these investigators used a national VA administrative database to identify all acute medical admissions to VA hospitals from 1997 to 2010. Patients who died, were transferred to another acute care facility, or whose LOS was longer than 30 days were excluded from consideration. Readmissions were defined as those that were linked to the index admission and occurred within 30 days of discharge. The cohort consisted of more than 4 million admissions and was further subdivided into 5 high-volume diagnoses: heart failure, chronic obstructive pulmonary disease (COPD), heart failure, acute myocardial infarction (AMI), community-acquired pneumonia, and gastrointestinal bleed. After adjusting for hospital and patient characteristics, LOS decreased during the 14-year period from 5.44 days to 3.98 days, and 30-day readmission rates decreased from 16.5% to 13.8%. Among the 5 high-volume conditions, LOS decreased the most for AMI (by almost 3 days) while readmission rates decreased the most for COPD (3.3%). Further analysis of all medical conditions showed that each additional day of stay resulted in a 3% increased rate of readmission. This was likely due to unmeasured severity of illness that affected both LOS and readmission. Of note, however, hospitals that had a mean LOS lower than the average LOS across all hospitals had higher readmissions rates (6% increase for each day lower than the average). Despite this, the overall readmission rate decreased over time as LOS decreased. All-cause mortality at 30 days and 90 days also improved over time.

Clinical question

Does decreased length of stay result in increased risk of 30-day readmission for hospitalized patients with acute medical illness?

Bottom line

Reduction in length of stay (LOS) is not associated with increased risk of 30-day readmission for patients with acute medical illness. Although this may suggest that decreased LOS does not affect quality of care, this finding may also be due to improved efficiencies in a previously inefficient Veteran Affairs (VA) system leading to earlier discharges and increased efforts at bettering transitions of care. LOE = 2b

Reference

Kaboli PJ, Go JT, Hockenberry J, et al. Associations between reduced hospital length of stay and 30-day readmission rate and mortality: 14-year experience in 129 Veterans Affairs hospitals. Ann Intern Med 2012;157(12):837-845.

Study design

Cohort (retrospective)

Funding source

Government

Allocation

Uncertain

Setting

Inpatient (any location)

Synopsis

To determine whether reductions in LOS adversely affect 30-day readmission rates, these investigators used a national VA administrative database to identify all acute medical admissions to VA hospitals from 1997 to 2010. Patients who died, were transferred to another acute care facility, or whose LOS was longer than 30 days were excluded from consideration. Readmissions were defined as those that were linked to the index admission and occurred within 30 days of discharge. The cohort consisted of more than 4 million admissions and was further subdivided into 5 high-volume diagnoses: heart failure, chronic obstructive pulmonary disease (COPD), heart failure, acute myocardial infarction (AMI), community-acquired pneumonia, and gastrointestinal bleed. After adjusting for hospital and patient characteristics, LOS decreased during the 14-year period from 5.44 days to 3.98 days, and 30-day readmission rates decreased from 16.5% to 13.8%. Among the 5 high-volume conditions, LOS decreased the most for AMI (by almost 3 days) while readmission rates decreased the most for COPD (3.3%). Further analysis of all medical conditions showed that each additional day of stay resulted in a 3% increased rate of readmission. This was likely due to unmeasured severity of illness that affected both LOS and readmission. Of note, however, hospitals that had a mean LOS lower than the average LOS across all hospitals had higher readmissions rates (6% increase for each day lower than the average). Despite this, the overall readmission rate decreased over time as LOS decreased. All-cause mortality at 30 days and 90 days also improved over time.

Clinical question

Do central venous catheters in the femoral vein increase the risk of catheter-related bloodstream infections as compared with those placed in the subclavian or internal jugular veins?

Bottom line

The risk of catheter-related bloodstream infections (CRBIs) from nontunneled central venous catheters has decreased in the last decade.This review suggests that there is no difference in risk of CRBIs when comparing catheters placed in femoral sites with those placed in subclavian or internal jugular (IJ) sites, especially when looking at data from more recent studies. LOE = 1a

Reference

Marik PE, Flemmer M, Harrison W. The risk of catheter-related bloodstream infection with femoral venous catheters as compared to subclavian and internal jugular venous catheters: a systematic review of the literature and meta-analysis. Crit Care Med 2012;40(8):2479-2485.

Study design

Meta-analysis (other)

Funding source

Unknown/not stated

Allocation

Uncertain

Setting

Inpatient (any location)

Synopsis

Current guidelines from the Centers for Disease Control recommend avoiding the femoral vein for central access in adult patients because of a potentially higher risk of CRBI. Two independent investigators searched MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, and bibliographies of relevant articles, as well as performed an Internet search, to find randomized controlled trials (RCTs) and cohort studies that examined the risk of CRBIs due to nontunneled central venous catheters placed in the femoral site as compared with those placed in the subclavian or IJ sites. Two RCTs, 8 cohort studies, and data from a Welsh infection control surveillance Web site were selected. Two authors independently extracted data from the selected studies. No formal quality assessment of the studies was performed. Data from the RCTs alone showed no difference in CRBIs between femoral sites and subclavian or IJ sites. Data from all the studies that compared femoral sites to subclavian sites showed no significant difference in the risk of CRBIs. For comparisons of femoral and IJ sites, the overall data favored the IJ site (relative risk of infection with femoral site placement = 1.90; 95% CI, 1.21-2.97; P = .005). However, 2 of the 9 included studies in this analysis were "statistical outliers," possibly due to unique circumstances in the hospitals in which they were performed, thus limiting their generalizability. When these 2 studies were removed from the analysis, there was no significant difference between femoral and IJ sites. For both comparisons (femoral vs subclavian and femoral vs IJ), there was an interaction between risk of infection and year of study publication, with earlier studies noting a greater risk of infection with femoral sites. Overall, this data confirms a decrease in incidence of CRBIs by more than 50% in the last 10 years. Additionally, study meta-analysis found no difference in the risk of deep venous thrombosis with femoral versus subclavian and IJ sites.

Clinical question

Do central venous catheters in the femoral vein increase the risk of catheter-related bloodstream infections as compared with those placed in the subclavian or internal jugular veins?

Bottom line

The risk of catheter-related bloodstream infections (CRBIs) from nontunneled central venous catheters has decreased in the last decade.This review suggests that there is no difference in risk of CRBIs when comparing catheters placed in femoral sites with those placed in subclavian or internal jugular (IJ) sites, especially when looking at data from more recent studies. LOE = 1a

Reference

Marik PE, Flemmer M, Harrison W. The risk of catheter-related bloodstream infection with femoral venous catheters as compared to subclavian and internal jugular venous catheters: a systematic review of the literature and meta-analysis. Crit Care Med 2012;40(8):2479-2485.

Study design

Meta-analysis (other)

Funding source

Unknown/not stated

Allocation

Uncertain

Setting

Inpatient (any location)

Synopsis

Current guidelines from the Centers for Disease Control recommend avoiding the femoral vein for central access in adult patients because of a potentially higher risk of CRBI. Two independent investigators searched MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, and bibliographies of relevant articles, as well as performed an Internet search, to find randomized controlled trials (RCTs) and cohort studies that examined the risk of CRBIs due to nontunneled central venous catheters placed in the femoral site as compared with those placed in the subclavian or IJ sites. Two RCTs, 8 cohort studies, and data from a Welsh infection control surveillance Web site were selected. Two authors independently extracted data from the selected studies. No formal quality assessment of the studies was performed. Data from the RCTs alone showed no difference in CRBIs between femoral sites and subclavian or IJ sites. Data from all the studies that compared femoral sites to subclavian sites showed no significant difference in the risk of CRBIs. For comparisons of femoral and IJ sites, the overall data favored the IJ site (relative risk of infection with femoral site placement = 1.90; 95% CI, 1.21-2.97; P = .005). However, 2 of the 9 included studies in this analysis were "statistical outliers," possibly due to unique circumstances in the hospitals in which they were performed, thus limiting their generalizability. When these 2 studies were removed from the analysis, there was no significant difference between femoral and IJ sites. For both comparisons (femoral vs subclavian and femoral vs IJ), there was an interaction between risk of infection and year of study publication, with earlier studies noting a greater risk of infection with femoral sites. Overall, this data confirms a decrease in incidence of CRBIs by more than 50% in the last 10 years. Additionally, study meta-analysis found no difference in the risk of deep venous thrombosis with femoral versus subclavian and IJ sites.

Clinical question

Do central venous catheters in the femoral vein increase the risk of catheter-related bloodstream infections as compared with those placed in the subclavian or internal jugular veins?

Bottom line

The risk of catheter-related bloodstream infections (CRBIs) from nontunneled central venous catheters has decreased in the last decade.This review suggests that there is no difference in risk of CRBIs when comparing catheters placed in femoral sites with those placed in subclavian or internal jugular (IJ) sites, especially when looking at data from more recent studies. LOE = 1a

Reference

Marik PE, Flemmer M, Harrison W. The risk of catheter-related bloodstream infection with femoral venous catheters as compared to subclavian and internal jugular venous catheters: a systematic review of the literature and meta-analysis. Crit Care Med 2012;40(8):2479-2485.

Study design

Meta-analysis (other)

Funding source

Unknown/not stated

Allocation

Uncertain

Setting

Inpatient (any location)

Synopsis

Current guidelines from the Centers for Disease Control recommend avoiding the femoral vein for central access in adult patients because of a potentially higher risk of CRBI. Two independent investigators searched MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, and bibliographies of relevant articles, as well as performed an Internet search, to find randomized controlled trials (RCTs) and cohort studies that examined the risk of CRBIs due to nontunneled central venous catheters placed in the femoral site as compared with those placed in the subclavian or IJ sites. Two RCTs, 8 cohort studies, and data from a Welsh infection control surveillance Web site were selected. Two authors independently extracted data from the selected studies. No formal quality assessment of the studies was performed. Data from the RCTs alone showed no difference in CRBIs between femoral sites and subclavian or IJ sites. Data from all the studies that compared femoral sites to subclavian sites showed no significant difference in the risk of CRBIs. For comparisons of femoral and IJ sites, the overall data favored the IJ site (relative risk of infection with femoral site placement = 1.90; 95% CI, 1.21-2.97; P = .005). However, 2 of the 9 included studies in this analysis were "statistical outliers," possibly due to unique circumstances in the hospitals in which they were performed, thus limiting their generalizability. When these 2 studies were removed from the analysis, there was no significant difference between femoral and IJ sites. For both comparisons (femoral vs subclavian and femoral vs IJ), there was an interaction between risk of infection and year of study publication, with earlier studies noting a greater risk of infection with femoral sites. Overall, this data confirms a decrease in incidence of CRBIs by more than 50% in the last 10 years. Additionally, study meta-analysis found no difference in the risk of deep venous thrombosis with femoral versus subclavian and IJ sites.

Norovirus is now the leading cause of acute gastroenteritis requiring medical care among U.S. children younger than 5 years of age, according to a report published online March 20 in the New England Journal of Medicine.

Now that rotavirus vaccines have dramatically reduced the number of acute gastroenteritis cases attributable to that organism, norovirus infections have taken over the lead in causing the disorder in the young U.S. pediatric population. Norovirus is responsible for an estimated 1 million health care visits each year for this age group, at an estimated cost approaching $300 million, said Daniel C. Payne, Ph.D., of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, and his associates.

"According to our estimation, by their fifth birthday, 1 in 278 U.S. children are hospitalized for norovirus infection, 1 in 14 are seen in the emergency department, and 1 in 6 are seen by outpatient care providers," the investigators noted.

They studied the epidemiology of the infection because now that candidate norovirus vaccines are in development, "there is a need to directly measure the pediatric health care burden of norovirus-associated gastroenteritis."

Dr. Payne and his colleagues analyzed data from the New Vaccine Surveillance Network, which collects information on the medical care of children residing near Rochester, N.Y.; Nashville, Tenn.; and Cincinnati – a catchment population exceeding 141,000 children under age 5.

The researchers prospectively assessed cases of acute gastroenteritis treated at hospitals, emergency departments, and outpatient clinics during two successive 12-month surveillance periods between October 2008 and September 2010. There were 1,077 cases the first year and 820 the second year; the data from these were compared with data from 806 age-matched children attending well-child visits, who served as a control group.

The disease burden of norovirus infection was "consistently high" during both years, accounting for 20%-22% of cases of acute gastroenteritis. Norovirus was detected in 4% of healthy controls in 2009. The overall rate of medical attention for the infection was highest – 47% – among children aged 6-18 months, Dr. Payne and his associates reported (N. Engl. J. Med. 2013;368:1121-30).

This study was supported by the CDC. Dr. Payne reported that he did not have any conflicts of interest relevant to this study. His coauthors reported ties to GlaxoSmithKline, Merck, and Luminex Molecular Diagnostics.

Norovirus is now the leading cause of acute gastroenteritis requiring medical care among U.S. children younger than 5 years of age, according to a report published online March 20 in the New England Journal of Medicine.

Now that rotavirus vaccines have dramatically reduced the number of acute gastroenteritis cases attributable to that organism, norovirus infections have taken over the lead in causing the disorder in the young U.S. pediatric population. Norovirus is responsible for an estimated 1 million health care visits each year for this age group, at an estimated cost approaching $300 million, said Daniel C. Payne, Ph.D., of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, and his associates.

"According to our estimation, by their fifth birthday, 1 in 278 U.S. children are hospitalized for norovirus infection, 1 in 14 are seen in the emergency department, and 1 in 6 are seen by outpatient care providers," the investigators noted.

They studied the epidemiology of the infection because now that candidate norovirus vaccines are in development, "there is a need to directly measure the pediatric health care burden of norovirus-associated gastroenteritis."

Dr. Payne and his colleagues analyzed data from the New Vaccine Surveillance Network, which collects information on the medical care of children residing near Rochester, N.Y.; Nashville, Tenn.; and Cincinnati – a catchment population exceeding 141,000 children under age 5.

The researchers prospectively assessed cases of acute gastroenteritis treated at hospitals, emergency departments, and outpatient clinics during two successive 12-month surveillance periods between October 2008 and September 2010. There were 1,077 cases the first year and 820 the second year; the data from these were compared with data from 806 age-matched children attending well-child visits, who served as a control group.

The disease burden of norovirus infection was "consistently high" during both years, accounting for 20%-22% of cases of acute gastroenteritis. Norovirus was detected in 4% of healthy controls in 2009. The overall rate of medical attention for the infection was highest – 47% – among children aged 6-18 months, Dr. Payne and his associates reported (N. Engl. J. Med. 2013;368:1121-30).

This study was supported by the CDC. Dr. Payne reported that he did not have any conflicts of interest relevant to this study. His coauthors reported ties to GlaxoSmithKline, Merck, and Luminex Molecular Diagnostics.

Norovirus is now the leading cause of acute gastroenteritis requiring medical care among U.S. children younger than 5 years of age, according to a report published online March 20 in the New England Journal of Medicine.

Now that rotavirus vaccines have dramatically reduced the number of acute gastroenteritis cases attributable to that organism, norovirus infections have taken over the lead in causing the disorder in the young U.S. pediatric population. Norovirus is responsible for an estimated 1 million health care visits each year for this age group, at an estimated cost approaching $300 million, said Daniel C. Payne, Ph.D., of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, and his associates.

"According to our estimation, by their fifth birthday, 1 in 278 U.S. children are hospitalized for norovirus infection, 1 in 14 are seen in the emergency department, and 1 in 6 are seen by outpatient care providers," the investigators noted.

They studied the epidemiology of the infection because now that candidate norovirus vaccines are in development, "there is a need to directly measure the pediatric health care burden of norovirus-associated gastroenteritis."

Dr. Payne and his colleagues analyzed data from the New Vaccine Surveillance Network, which collects information on the medical care of children residing near Rochester, N.Y.; Nashville, Tenn.; and Cincinnati – a catchment population exceeding 141,000 children under age 5.

The researchers prospectively assessed cases of acute gastroenteritis treated at hospitals, emergency departments, and outpatient clinics during two successive 12-month surveillance periods between October 2008 and September 2010. There were 1,077 cases the first year and 820 the second year; the data from these were compared with data from 806 age-matched children attending well-child visits, who served as a control group.

The disease burden of norovirus infection was "consistently high" during both years, accounting for 20%-22% of cases of acute gastroenteritis. Norovirus was detected in 4% of healthy controls in 2009. The overall rate of medical attention for the infection was highest – 47% – among children aged 6-18 months, Dr. Payne and his associates reported (N. Engl. J. Med. 2013;368:1121-30).

This study was supported by the CDC. Dr. Payne reported that he did not have any conflicts of interest relevant to this study. His coauthors reported ties to GlaxoSmithKline, Merck, and Luminex Molecular Diagnostics.

Inappropriate use of prescription opioids is a major public health challenge, prompting the U.S. Food and Drug Administration (FDA) to issue a draft guidance document aimed at helping industry create new formulations of opioids with abuse-deterrent properties.

Released in January, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” provides recommendations for conducting studies to prove that a particular formulation contains abuse-deterrent properties. It also explains how the FDA will review the results and determine which labeling claims to approve.

This announcement is “one component of our larger effort to prevent prescription drug abuse and misuse, while ensuring that patients in pain continue to have access to these important medicines,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said during a teleconference.

According to the FDA guidance, opioid analgesics can be abused in a variety of ways:

• Swallowed whole;
• Crushed and swallowed;
• Crushed and snorted;
• Crushed and smoked; or
• Crushed, dissolved, and injected.

With the science of abuse deterrence being relatively new, the FDA plans to take a flexible and adaptive approach. That’s because the analytical, clinical, and statistical methods for evaluating formulation technologies are still evolving.

“Physicians should care about this because the government is regulating prescribing practices more directly than in the past, especially with pain drugs,” says Daniel Carpenter, PhD, a Harvard University government professor and author on FDA pharmaceutical regulation. “The FDA and federal agencies are going to be leaning more heavily upon physicians.”

To date, the majority of current abuse-deterrent technologies have not been effective in preventing the most widespread type of abuse—ingesting a number of pills or tablets to reach a state of euphoria.

Science points toward ways that formulations can help thwart abuse. For instance, adding an opioid antagonist can hinder, limit, or defeat euphoria. An antagonist can be sequestered and released only upon the product’s manipulation. In one such scenario, the substance acting as an antagonist could be clinically inactive when swallowed, but then would become active if the product is crushed and injected or snorted.

“The guidance describes advice for the development of abuse-deterrent opioids and does not describe practice guidelines,” says Christopher Kelly, an FDA spokesman. However, he adds, “[FDA] urges all prescribers of extended-release and long-acting opioids to participate in the training under the Risk Evaluation and Mitigation Strategy (REMS).” The first REMS-compliant training is expected to become available by March 1.

Such a strategy is intended to manage known or potential serious risks associated with a drug product. The FDA requires it to ensure that the benefits of a drug outweigh its risks.

Manufacturers of opioid analgesics have worked with the FDA to produce materials for the REMS program that would inform healthcare professionals about safe prescribing. Continuing-education providers also are designing accredited training. (For more information, listen to this NIH podcast about training to help providers prescribe painkillers properly.)

Prescribers are advised to complete a REMS-compliant program through an accredited continuing-education provider for their discipline. They should discuss the safe use, serious risks, storage, and disposal of opioids with patients and caregivers each time they prescribe these medicines. It’s also essential to stress the importance of reading the medication guide they will receive from the pharmacist at drug-dispensing time.

Whether the FDA’s industry guidance for the development of abuse-deterrent opioids will make a difference remains to be seen, according to Carpenter. The addictive potential of opioids has created “a kind of public health epidemic,” he says. “It’s not an infectious epidemic in the sense of the flu, but it’s socially and behaviorally infectious and very destructive.”

Creating better tamper-resistant drugs could impede someone from “taking a longer-acting version and breaking it down into a much more toxic soup for other purposes,” Carpenter says. However, he concedes it won’t be impossible to swallow one or more pills too many, leading to this very common form of pharmaceutical abuse.

The FDA is accepting public comment on the draft guidance, while encouraging further scientific and clinical research to advance the development and assessment of abuse-deterrent technologies.

Susan Kreimer is a freelance writer based in New York.

Inappropriate use of prescription opioids is a major public health challenge, prompting the U.S. Food and Drug Administration (FDA) to issue a draft guidance document aimed at helping industry create new formulations of opioids with abuse-deterrent properties.

Released in January, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” provides recommendations for conducting studies to prove that a particular formulation contains abuse-deterrent properties. It also explains how the FDA will review the results and determine which labeling claims to approve.

This announcement is “one component of our larger effort to prevent prescription drug abuse and misuse, while ensuring that patients in pain continue to have access to these important medicines,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said during a teleconference.

According to the FDA guidance, opioid analgesics can be abused in a variety of ways:

• Swallowed whole;
• Crushed and swallowed;
• Crushed and snorted;
• Crushed and smoked; or
• Crushed, dissolved, and injected.

With the science of abuse deterrence being relatively new, the FDA plans to take a flexible and adaptive approach. That’s because the analytical, clinical, and statistical methods for evaluating formulation technologies are still evolving.

“Physicians should care about this because the government is regulating prescribing practices more directly than in the past, especially with pain drugs,” says Daniel Carpenter, PhD, a Harvard University government professor and author on FDA pharmaceutical regulation. “The FDA and federal agencies are going to be leaning more heavily upon physicians.”

To date, the majority of current abuse-deterrent technologies have not been effective in preventing the most widespread type of abuse—ingesting a number of pills or tablets to reach a state of euphoria.

Science points toward ways that formulations can help thwart abuse. For instance, adding an opioid antagonist can hinder, limit, or defeat euphoria. An antagonist can be sequestered and released only upon the product’s manipulation. In one such scenario, the substance acting as an antagonist could be clinically inactive when swallowed, but then would become active if the product is crushed and injected or snorted.

“The guidance describes advice for the development of abuse-deterrent opioids and does not describe practice guidelines,” says Christopher Kelly, an FDA spokesman. However, he adds, “[FDA] urges all prescribers of extended-release and long-acting opioids to participate in the training under the Risk Evaluation and Mitigation Strategy (REMS).” The first REMS-compliant training is expected to become available by March 1.

Such a strategy is intended to manage known or potential serious risks associated with a drug product. The FDA requires it to ensure that the benefits of a drug outweigh its risks.

Manufacturers of opioid analgesics have worked with the FDA to produce materials for the REMS program that would inform healthcare professionals about safe prescribing. Continuing-education providers also are designing accredited training. (For more information, listen to this NIH podcast about training to help providers prescribe painkillers properly.)

Prescribers are advised to complete a REMS-compliant program through an accredited continuing-education provider for their discipline. They should discuss the safe use, serious risks, storage, and disposal of opioids with patients and caregivers each time they prescribe these medicines. It’s also essential to stress the importance of reading the medication guide they will receive from the pharmacist at drug-dispensing time.

Whether the FDA’s industry guidance for the development of abuse-deterrent opioids will make a difference remains to be seen, according to Carpenter. The addictive potential of opioids has created “a kind of public health epidemic,” he says. “It’s not an infectious epidemic in the sense of the flu, but it’s socially and behaviorally infectious and very destructive.”

Creating better tamper-resistant drugs could impede someone from “taking a longer-acting version and breaking it down into a much more toxic soup for other purposes,” Carpenter says. However, he concedes it won’t be impossible to swallow one or more pills too many, leading to this very common form of pharmaceutical abuse.

The FDA is accepting public comment on the draft guidance, while encouraging further scientific and clinical research to advance the development and assessment of abuse-deterrent technologies.

Susan Kreimer is a freelance writer based in New York.

Inappropriate use of prescription opioids is a major public health challenge, prompting the U.S. Food and Drug Administration (FDA) to issue a draft guidance document aimed at helping industry create new formulations of opioids with abuse-deterrent properties.

Released in January, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” provides recommendations for conducting studies to prove that a particular formulation contains abuse-deterrent properties. It also explains how the FDA will review the results and determine which labeling claims to approve.

This announcement is “one component of our larger effort to prevent prescription drug abuse and misuse, while ensuring that patients in pain continue to have access to these important medicines,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said during a teleconference.

According to the FDA guidance, opioid analgesics can be abused in a variety of ways:

• Swallowed whole;
• Crushed and swallowed;
• Crushed and snorted;
• Crushed and smoked; or
• Crushed, dissolved, and injected.

With the science of abuse deterrence being relatively new, the FDA plans to take a flexible and adaptive approach. That’s because the analytical, clinical, and statistical methods for evaluating formulation technologies are still evolving.

“Physicians should care about this because the government is regulating prescribing practices more directly than in the past, especially with pain drugs,” says Daniel Carpenter, PhD, a Harvard University government professor and author on FDA pharmaceutical regulation. “The FDA and federal agencies are going to be leaning more heavily upon physicians.”

To date, the majority of current abuse-deterrent technologies have not been effective in preventing the most widespread type of abuse—ingesting a number of pills or tablets to reach a state of euphoria.

Science points toward ways that formulations can help thwart abuse. For instance, adding an opioid antagonist can hinder, limit, or defeat euphoria. An antagonist can be sequestered and released only upon the product’s manipulation. In one such scenario, the substance acting as an antagonist could be clinically inactive when swallowed, but then would become active if the product is crushed and injected or snorted.

“The guidance describes advice for the development of abuse-deterrent opioids and does not describe practice guidelines,” says Christopher Kelly, an FDA spokesman. However, he adds, “[FDA] urges all prescribers of extended-release and long-acting opioids to participate in the training under the Risk Evaluation and Mitigation Strategy (REMS).” The first REMS-compliant training is expected to become available by March 1.

Such a strategy is intended to manage known or potential serious risks associated with a drug product. The FDA requires it to ensure that the benefits of a drug outweigh its risks.

Manufacturers of opioid analgesics have worked with the FDA to produce materials for the REMS program that would inform healthcare professionals about safe prescribing. Continuing-education providers also are designing accredited training. (For more information, listen to this NIH podcast about training to help providers prescribe painkillers properly.)

Prescribers are advised to complete a REMS-compliant program through an accredited continuing-education provider for their discipline. They should discuss the safe use, serious risks, storage, and disposal of opioids with patients and caregivers each time they prescribe these medicines. It’s also essential to stress the importance of reading the medication guide they will receive from the pharmacist at drug-dispensing time.

Whether the FDA’s industry guidance for the development of abuse-deterrent opioids will make a difference remains to be seen, according to Carpenter. The addictive potential of opioids has created “a kind of public health epidemic,” he says. “It’s not an infectious epidemic in the sense of the flu, but it’s socially and behaviorally infectious and very destructive.”

Creating better tamper-resistant drugs could impede someone from “taking a longer-acting version and breaking it down into a much more toxic soup for other purposes,” Carpenter says. However, he concedes it won’t be impossible to swallow one or more pills too many, leading to this very common form of pharmaceutical abuse.

The FDA is accepting public comment on the draft guidance, while encouraging further scientific and clinical research to advance the development and assessment of abuse-deterrent technologies.

Susan Kreimer is a freelance writer based in New York.

SAN FRANCISCO – The venerable antihyperuricemic agent allopurinol has shown early promise for two novel cardiovascular applications: prevention of atrial fibrillation in the setting of heart failure and reduction of left ventricular hypertrophy in patients with type 2 diabetes.

Allopurinol is a xanthine oxidase inhibitor and antigout drug. The rationale for the drug’s use in reducing the incidence of atrial fibrillation in patients with heart failure lies in the observation that serum uric acid has emerged as an independent marker of mortality and a predictor of new-onset atrial fibrillation in heart failure. Xanthine oxidase is not only a source of reactive oxygen species that adversely affect myocardial function, but it also catalyzes the conversion of xanthine to uric acid, Dr. Fernando E. Hernandez explained at the annual meeting of the American College of Cardiology.

He presented a retrospective cohort study involving 603 patients enrolled in the Miami Veterans Affairs heart failure clinic. The 103 on allopurinol, and the 500 who were not, matched up well in terms of baseline characteristics including age, prevalence of coronary artery disease, median left ventricular ejection, left atrial size, and use of guideline-recommended ACE inhibitors and beta-blockers.

During up to 5 years of follow-up, the incidence of new-onset atrial fibrillation was 184 cases/1,000 person-years in the allopurinol users compared with 252/1,000 person-years in controls. In a Cox proportional hazards analysis adjusted for small differences in potential confounders, the use of allopurinol was independently associated with a 47% reduction in the risk of atrial fibrillation (P = .04), reported Dr. Hernandez of the University of Miami.

This intriguing finding needs to be confirmed in randomized prospective trials, he noted.

In a separate presentation, Dr. Benjamin R. Szwejkowski noted that left ventricular hypertrophy (LVH) is common in patients with type 2 diabetes and contributes to their elevated risk of cardiovascular morbidity and mortality.

Based on their hypothesis that LVH is related in part to oxidative stress and reducing that stress via xanthine oxidase inhibition using allopurinol can cause LVH regression, the investigators conducted a randomized, double-blind placebo-controlled clinical trial. Sixty-six patients with type 2 diabetes and echocardiographic evidence of LVH were randomized to allopurinol at 600 mg/day or placebo for 9 months.

The primary study endpoint was change in left ventricular mass between baseline and 9 months, as measured by cardiac MRI. Allopurinol resulted in a significant mean 2.65-g reduction in LV mass, while in the control group LV mass increased by 1.21 g. Similarly, LV mass indexed to body surface area fell significantly by 1.32 g/m² in the allopurinol group while increasing by 0.65 g/m² in the placebo arm, reported Dr. Szwejkowski of the University of Dundee(Scotland).

"Allopurinol may be a useful therapy to reduce cardiovascular risk in type 2 diabetic patients with LVH," according to the cardiologist.

Flow-mediated dilatation didn’t change significantly over time in either study group.

Dr. Szwejkowski and Dr. Hernandez reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

SAN FRANCISCO – The venerable antihyperuricemic agent allopurinol has shown early promise for two novel cardiovascular applications: prevention of atrial fibrillation in the setting of heart failure and reduction of left ventricular hypertrophy in patients with type 2 diabetes.

Allopurinol is a xanthine oxidase inhibitor and antigout drug. The rationale for the drug’s use in reducing the incidence of atrial fibrillation in patients with heart failure lies in the observation that serum uric acid has emerged as an independent marker of mortality and a predictor of new-onset atrial fibrillation in heart failure. Xanthine oxidase is not only a source of reactive oxygen species that adversely affect myocardial function, but it also catalyzes the conversion of xanthine to uric acid, Dr. Fernando E. Hernandez explained at the annual meeting of the American College of Cardiology.

He presented a retrospective cohort study involving 603 patients enrolled in the Miami Veterans Affairs heart failure clinic. The 103 on allopurinol, and the 500 who were not, matched up well in terms of baseline characteristics including age, prevalence of coronary artery disease, median left ventricular ejection, left atrial size, and use of guideline-recommended ACE inhibitors and beta-blockers.

During up to 5 years of follow-up, the incidence of new-onset atrial fibrillation was 184 cases/1,000 person-years in the allopurinol users compared with 252/1,000 person-years in controls. In a Cox proportional hazards analysis adjusted for small differences in potential confounders, the use of allopurinol was independently associated with a 47% reduction in the risk of atrial fibrillation (P = .04), reported Dr. Hernandez of the University of Miami.

This intriguing finding needs to be confirmed in randomized prospective trials, he noted.

In a separate presentation, Dr. Benjamin R. Szwejkowski noted that left ventricular hypertrophy (LVH) is common in patients with type 2 diabetes and contributes to their elevated risk of cardiovascular morbidity and mortality.

Based on their hypothesis that LVH is related in part to oxidative stress and reducing that stress via xanthine oxidase inhibition using allopurinol can cause LVH regression, the investigators conducted a randomized, double-blind placebo-controlled clinical trial. Sixty-six patients with type 2 diabetes and echocardiographic evidence of LVH were randomized to allopurinol at 600 mg/day or placebo for 9 months.

The primary study endpoint was change in left ventricular mass between baseline and 9 months, as measured by cardiac MRI. Allopurinol resulted in a significant mean 2.65-g reduction in LV mass, while in the control group LV mass increased by 1.21 g. Similarly, LV mass indexed to body surface area fell significantly by 1.32 g/m² in the allopurinol group while increasing by 0.65 g/m² in the placebo arm, reported Dr. Szwejkowski of the University of Dundee(Scotland).

"Allopurinol may be a useful therapy to reduce cardiovascular risk in type 2 diabetic patients with LVH," according to the cardiologist.

Flow-mediated dilatation didn’t change significantly over time in either study group.

Dr. Szwejkowski and Dr. Hernandez reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

SAN FRANCISCO – The venerable antihyperuricemic agent allopurinol has shown early promise for two novel cardiovascular applications: prevention of atrial fibrillation in the setting of heart failure and reduction of left ventricular hypertrophy in patients with type 2 diabetes.

Allopurinol is a xanthine oxidase inhibitor and antigout drug. The rationale for the drug’s use in reducing the incidence of atrial fibrillation in patients with heart failure lies in the observation that serum uric acid has emerged as an independent marker of mortality and a predictor of new-onset atrial fibrillation in heart failure. Xanthine oxidase is not only a source of reactive oxygen species that adversely affect myocardial function, but it also catalyzes the conversion of xanthine to uric acid, Dr. Fernando E. Hernandez explained at the annual meeting of the American College of Cardiology.

He presented a retrospective cohort study involving 603 patients enrolled in the Miami Veterans Affairs heart failure clinic. The 103 on allopurinol, and the 500 who were not, matched up well in terms of baseline characteristics including age, prevalence of coronary artery disease, median left ventricular ejection, left atrial size, and use of guideline-recommended ACE inhibitors and beta-blockers.

During up to 5 years of follow-up, the incidence of new-onset atrial fibrillation was 184 cases/1,000 person-years in the allopurinol users compared with 252/1,000 person-years in controls. In a Cox proportional hazards analysis adjusted for small differences in potential confounders, the use of allopurinol was independently associated with a 47% reduction in the risk of atrial fibrillation (P = .04), reported Dr. Hernandez of the University of Miami.

This intriguing finding needs to be confirmed in randomized prospective trials, he noted.

In a separate presentation, Dr. Benjamin R. Szwejkowski noted that left ventricular hypertrophy (LVH) is common in patients with type 2 diabetes and contributes to their elevated risk of cardiovascular morbidity and mortality.

Based on their hypothesis that LVH is related in part to oxidative stress and reducing that stress via xanthine oxidase inhibition using allopurinol can cause LVH regression, the investigators conducted a randomized, double-blind placebo-controlled clinical trial. Sixty-six patients with type 2 diabetes and echocardiographic evidence of LVH were randomized to allopurinol at 600 mg/day or placebo for 9 months.

The primary study endpoint was change in left ventricular mass between baseline and 9 months, as measured by cardiac MRI. Allopurinol resulted in a significant mean 2.65-g reduction in LV mass, while in the control group LV mass increased by 1.21 g. Similarly, LV mass indexed to body surface area fell significantly by 1.32 g/m² in the allopurinol group while increasing by 0.65 g/m² in the placebo arm, reported Dr. Szwejkowski of the University of Dundee(Scotland).

"Allopurinol may be a useful therapy to reduce cardiovascular risk in type 2 diabetic patients with LVH," according to the cardiologist.

Flow-mediated dilatation didn’t change significantly over time in either study group.

Dr. Szwejkowski and Dr. Hernandez reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

Any athlete with a possible concussion should be immediately removed from play pending an evaluation by a licensed health care provider trained in assessing concussions and traumatic brain injury, according to a new guideline from the American Academy of Neurology.

The guideline for evaluating and managing athletes with concussion was published online in the journal Neurology on March 18 (doi:10.1212/WNL.0b013e31828d57dd) in conjunction with the annual meeting of the AAN. The guideline replaces the Academy’s 1997 recommendations, which stressed using a grading system to try to predict concussion outcomes.

© james boulette/iStockphoto.com

The new guideline takes a more individualized and conservative approach, especially for younger athletes. The new approach comes as many states have enacted legislation regulating when young athletes can return to play following a concussion.

"If in doubt, sit it out," Dr. Jeffrey S. Kutcher, coauthor of the guideline and a neurologist at the University of Michigan in Ann Arbor, said in a statement. "Being seen by a trained professional is extremely important after a concussion. If headaches or other symptoms return with the start of exercise, stop the activity and consult a doctor. You only get one brain; treat it well."

The new guideline calls for athletes to stay off the field until they are asymptomatic off medication. High school athletes and younger players with a concussion should be managed more conservatively since they take longer to recover than older athletes, according to the AAN.

But there is not enough evidence to support complete rest after a concussion. Activities that do not worsen symptoms and don’t pose a risk of another concussion can be part of the management of the injury, according to the guideline.

"We’re moved away from the concussion grading systems we first established in 1997 and are now recommending concussion and return to play be assessed in each athlete individually," Dr. Christopher C. Giza, the co–lead guideline author and a neurologist at Mattel Children’s Hospital at the University of California, Los Angeles, said in a statement. "There is no set timeline for safe return to play."

The AAN expert panel recommends that sideline providers use symptom checklists such as the Standardized Assessment of Concussion to help identify suspected concussion and that the scores be shared with the physicians involved in the athletes’ care off the field. But these checklists should not be the only tool used in making a diagnosis, according to the guidelines. Also, the checklist scores may be more useful if they are compared against preinjury individual scores, especially in younger athletes and those with prior concussions.

CT imaging should not be used to diagnose a suspected sport-related concussion, according to the guideline. But imaging might be used to rule out more serious traumatic brain injuries, such as intracranial hemorrhage in athletes with a suspected concussion who also have a loss of consciousness, posttraumatic amnesia, persistently altered mental status, focal neurologic deficit, evidence of skull fracture, or signs of clinical deterioration.

Athletes are at greater risk of concussion if they have a history of concussion. The first 10 days after a concussion pose the greatest risk for a repeat injury.

The AAN advises physicians to be on the lookout for ongoing symptoms that are linked to a longer recovery, such as continued headache or fogginess. Athletes with a history of concussions and younger players also tend to have a longer recovery.

The guideline also include level C recommendations stating that health care providers "might" develop individualized graded plans for returning to physical and cognitive activity. They might also provide cognitive restructuring counseling in an effort to shorten the duration of symptoms and the likelihood of developing chronic post-concussion syndrome, according to the guideline.

The guideline also included a number of recommendations on areas for future research, including studies of pre–high school age athletes to determine the natural history of concussion and recovery time for this age group, as well as the best assessment tools. The expert panel also called for clinical trials of different postconcussion management strategies and return-to-play protocols.

The guidelines were developed by a multidisciplinary expert committee that included representatives from neurology, athletic training, neuropsychology, epidemiology and biostatistics, neurosurgery, physical medicine and rehabilitation, and sports medicine. Many of the authors reported serving as consultants for professional sports associations, receiving honoraria and funding for travel for lectures on sports concussion, receiving research support from various foundations and organizations, and providing expert testimony in legal cases involving traumatic brain injury or concussion.

Any athlete with a possible concussion should be immediately removed from play pending an evaluation by a licensed health care provider trained in assessing concussions and traumatic brain injury, according to a new guideline from the American Academy of Neurology.

The guideline for evaluating and managing athletes with concussion was published online in the journal Neurology on March 18 (doi:10.1212/WNL.0b013e31828d57dd) in conjunction with the annual meeting of the AAN. The guideline replaces the Academy’s 1997 recommendations, which stressed using a grading system to try to predict concussion outcomes.

© james boulette/iStockphoto.com

The new guideline takes a more individualized and conservative approach, especially for younger athletes. The new approach comes as many states have enacted legislation regulating when young athletes can return to play following a concussion.

"If in doubt, sit it out," Dr. Jeffrey S. Kutcher, coauthor of the guideline and a neurologist at the University of Michigan in Ann Arbor, said in a statement. "Being seen by a trained professional is extremely important after a concussion. If headaches or other symptoms return with the start of exercise, stop the activity and consult a doctor. You only get one brain; treat it well."

The new guideline calls for athletes to stay off the field until they are asymptomatic off medication. High school athletes and younger players with a concussion should be managed more conservatively since they take longer to recover than older athletes, according to the AAN.

But there is not enough evidence to support complete rest after a concussion. Activities that do not worsen symptoms and don’t pose a risk of another concussion can be part of the management of the injury, according to the guideline.

"We’re moved away from the concussion grading systems we first established in 1997 and are now recommending concussion and return to play be assessed in each athlete individually," Dr. Christopher C. Giza, the co–lead guideline author and a neurologist at Mattel Children’s Hospital at the University of California, Los Angeles, said in a statement. "There is no set timeline for safe return to play."

The AAN expert panel recommends that sideline providers use symptom checklists such as the Standardized Assessment of Concussion to help identify suspected concussion and that the scores be shared with the physicians involved in the athletes’ care off the field. But these checklists should not be the only tool used in making a diagnosis, according to the guidelines. Also, the checklist scores may be more useful if they are compared against preinjury individual scores, especially in younger athletes and those with prior concussions.

CT imaging should not be used to diagnose a suspected sport-related concussion, according to the guideline. But imaging might be used to rule out more serious traumatic brain injuries, such as intracranial hemorrhage in athletes with a suspected concussion who also have a loss of consciousness, posttraumatic amnesia, persistently altered mental status, focal neurologic deficit, evidence of skull fracture, or signs of clinical deterioration.

Athletes are at greater risk of concussion if they have a history of concussion. The first 10 days after a concussion pose the greatest risk for a repeat injury.

The AAN advises physicians to be on the lookout for ongoing symptoms that are linked to a longer recovery, such as continued headache or fogginess. Athletes with a history of concussions and younger players also tend to have a longer recovery.

The guideline also include level C recommendations stating that health care providers "might" develop individualized graded plans for returning to physical and cognitive activity. They might also provide cognitive restructuring counseling in an effort to shorten the duration of symptoms and the likelihood of developing chronic post-concussion syndrome, according to the guideline.

The guideline also included a number of recommendations on areas for future research, including studies of pre–high school age athletes to determine the natural history of concussion and recovery time for this age group, as well as the best assessment tools. The expert panel also called for clinical trials of different postconcussion management strategies and return-to-play protocols.

The guidelines were developed by a multidisciplinary expert committee that included representatives from neurology, athletic training, neuropsychology, epidemiology and biostatistics, neurosurgery, physical medicine and rehabilitation, and sports medicine. Many of the authors reported serving as consultants for professional sports associations, receiving honoraria and funding for travel for lectures on sports concussion, receiving research support from various foundations and organizations, and providing expert testimony in legal cases involving traumatic brain injury or concussion.

Any athlete with a possible concussion should be immediately removed from play pending an evaluation by a licensed health care provider trained in assessing concussions and traumatic brain injury, according to a new guideline from the American Academy of Neurology.

The guideline for evaluating and managing athletes with concussion was published online in the journal Neurology on March 18 (doi:10.1212/WNL.0b013e31828d57dd) in conjunction with the annual meeting of the AAN. The guideline replaces the Academy’s 1997 recommendations, which stressed using a grading system to try to predict concussion outcomes.

© james boulette/iStockphoto.com

The new guideline takes a more individualized and conservative approach, especially for younger athletes. The new approach comes as many states have enacted legislation regulating when young athletes can return to play following a concussion.

"If in doubt, sit it out," Dr. Jeffrey S. Kutcher, coauthor of the guideline and a neurologist at the University of Michigan in Ann Arbor, said in a statement. "Being seen by a trained professional is extremely important after a concussion. If headaches or other symptoms return with the start of exercise, stop the activity and consult a doctor. You only get one brain; treat it well."

The new guideline calls for athletes to stay off the field until they are asymptomatic off medication. High school athletes and younger players with a concussion should be managed more conservatively since they take longer to recover than older athletes, according to the AAN.

But there is not enough evidence to support complete rest after a concussion. Activities that do not worsen symptoms and don’t pose a risk of another concussion can be part of the management of the injury, according to the guideline.

"We’re moved away from the concussion grading systems we first established in 1997 and are now recommending concussion and return to play be assessed in each athlete individually," Dr. Christopher C. Giza, the co–lead guideline author and a neurologist at Mattel Children’s Hospital at the University of California, Los Angeles, said in a statement. "There is no set timeline for safe return to play."

The AAN expert panel recommends that sideline providers use symptom checklists such as the Standardized Assessment of Concussion to help identify suspected concussion and that the scores be shared with the physicians involved in the athletes’ care off the field. But these checklists should not be the only tool used in making a diagnosis, according to the guidelines. Also, the checklist scores may be more useful if they are compared against preinjury individual scores, especially in younger athletes and those with prior concussions.

CT imaging should not be used to diagnose a suspected sport-related concussion, according to the guideline. But imaging might be used to rule out more serious traumatic brain injuries, such as intracranial hemorrhage in athletes with a suspected concussion who also have a loss of consciousness, posttraumatic amnesia, persistently altered mental status, focal neurologic deficit, evidence of skull fracture, or signs of clinical deterioration.

Athletes are at greater risk of concussion if they have a history of concussion. The first 10 days after a concussion pose the greatest risk for a repeat injury.

The AAN advises physicians to be on the lookout for ongoing symptoms that are linked to a longer recovery, such as continued headache or fogginess. Athletes with a history of concussions and younger players also tend to have a longer recovery.

The guideline also include level C recommendations stating that health care providers "might" develop individualized graded plans for returning to physical and cognitive activity. They might also provide cognitive restructuring counseling in an effort to shorten the duration of symptoms and the likelihood of developing chronic post-concussion syndrome, according to the guideline.

The guideline also included a number of recommendations on areas for future research, including studies of pre–high school age athletes to determine the natural history of concussion and recovery time for this age group, as well as the best assessment tools. The expert panel also called for clinical trials of different postconcussion management strategies and return-to-play protocols.

The guidelines were developed by a multidisciplinary expert committee that included representatives from neurology, athletic training, neuropsychology, epidemiology and biostatistics, neurosurgery, physical medicine and rehabilitation, and sports medicine. Many of the authors reported serving as consultants for professional sports associations, receiving honoraria and funding for travel for lectures on sports concussion, receiving research support from various foundations and organizations, and providing expert testimony in legal cases involving traumatic brain injury or concussion.

Hospitalists should be on the lookout for carbapenem-resistant Enterobacteriaceae (CRE) infections, says one author of a CDC report that noted a three-fold increase in the proportion of Enterobacteriaceae bugs that proved resistant to carbapenem within the past decade.

Earlier this month, the CDC's Morbidity and Mortality Weekly Report revealed that the percentage of CRE infections jumped to 4.2% in 2011 from 1.2% in 2001, according to data from the National Nosocomial Infection Surveillance system.

"It is a very serious public health threat," says co-author Alex Kallen, MD, MPH, a medical epidemiologist and outbreak response coordinator in the CDC's Division of Healthcare Quality Promotion. "Maybe it's not that common now, but with no action, it has the potential to become much more common, like a lot of the other MDROs [multidrug-resistant organisms] that hospitalists see regularly. [Hospitalists] have a lot of control over some of the things that could potentially lead to increased transmission."

Dr. Kallen says HM groups can help reduce the spread of CRE through antibiotic stewardship, the review of detailed patient histories to ferret out risk factors, and dedication to contact precautions and hand hygiene. Hospitalists also play a leadership role in coordinating efforts for patients transferring between hospitals and other institutions, such as skilled-nursing or assisted-living facilities, he says.

Dr. Kallen added that hospitalists should not dismiss CRE, even if they rarely encounter it.

"If you're a place that doesn't see this very often, and you see one, that's a big deal," he adds. "It needs to be acted on aggressively. Being proactive is much more effective than waiting until it's common and then trying to intervene."

Visit our website for more information on hospital-acquired infections.

Hospitalists should be on the lookout for carbapenem-resistant Enterobacteriaceae (CRE) infections, says one author of a CDC report that noted a three-fold increase in the proportion of Enterobacteriaceae bugs that proved resistant to carbapenem within the past decade.

Earlier this month, the CDC's Morbidity and Mortality Weekly Report revealed that the percentage of CRE infections jumped to 4.2% in 2011 from 1.2% in 2001, according to data from the National Nosocomial Infection Surveillance system.

"It is a very serious public health threat," says co-author Alex Kallen, MD, MPH, a medical epidemiologist and outbreak response coordinator in the CDC's Division of Healthcare Quality Promotion. "Maybe it's not that common now, but with no action, it has the potential to become much more common, like a lot of the other MDROs [multidrug-resistant organisms] that hospitalists see regularly. [Hospitalists] have a lot of control over some of the things that could potentially lead to increased transmission."

Dr. Kallen says HM groups can help reduce the spread of CRE through antibiotic stewardship, the review of detailed patient histories to ferret out risk factors, and dedication to contact precautions and hand hygiene. Hospitalists also play a leadership role in coordinating efforts for patients transferring between hospitals and other institutions, such as skilled-nursing or assisted-living facilities, he says.

Dr. Kallen added that hospitalists should not dismiss CRE, even if they rarely encounter it.

"If you're a place that doesn't see this very often, and you see one, that's a big deal," he adds. "It needs to be acted on aggressively. Being proactive is much more effective than waiting until it's common and then trying to intervene."

Visit our website for more information on hospital-acquired infections.

Hospitalists should be on the lookout for carbapenem-resistant Enterobacteriaceae (CRE) infections, says one author of a CDC report that noted a three-fold increase in the proportion of Enterobacteriaceae bugs that proved resistant to carbapenem within the past decade.

Earlier this month, the CDC's Morbidity and Mortality Weekly Report revealed that the percentage of CRE infections jumped to 4.2% in 2011 from 1.2% in 2001, according to data from the National Nosocomial Infection Surveillance system.

"It is a very serious public health threat," says co-author Alex Kallen, MD, MPH, a medical epidemiologist and outbreak response coordinator in the CDC's Division of Healthcare Quality Promotion. "Maybe it's not that common now, but with no action, it has the potential to become much more common, like a lot of the other MDROs [multidrug-resistant organisms] that hospitalists see regularly. [Hospitalists] have a lot of control over some of the things that could potentially lead to increased transmission."

Dr. Kallen says HM groups can help reduce the spread of CRE through antibiotic stewardship, the review of detailed patient histories to ferret out risk factors, and dedication to contact precautions and hand hygiene. Hospitalists also play a leadership role in coordinating efforts for patients transferring between hospitals and other institutions, such as skilled-nursing or assisted-living facilities, he says.

Dr. Kallen added that hospitalists should not dismiss CRE, even if they rarely encounter it.

"If you're a place that doesn't see this very often, and you see one, that's a big deal," he adds. "It needs to be acted on aggressively. Being proactive is much more effective than waiting until it's common and then trying to intervene."

Visit our website for more information on hospital-acquired infections.

The Robert Wood Johnson Foundation of Princeton, N.J., the country’s largest healthcare-focused philanthropy, has undertaken a number of initiatives to improve care transitions and reduce preventable hospital readmissions.

One of the key conclusions from these initiatives, says Anne Weiss, MPP, director of the foundation's Quality/Equality Health Care Team, is that hospitals and hospitalists can't do it alone. "Hospitals are now being held financially accountable for something they can't possibly control," Weiss says, referring to whether or not the discharged patient returns to the hospital within 30 days.

The foundation has mobilized broad community coalitions through its Aligning Forces for Quality campaign, bringing together healthcare providers, purchasers, consumers, and other stakeholders to improve care transitions. One such coalition, Better Health Greater Cleveland of Ohio, announced a 10.7% reduction in avoidable hospitalizations for common cardiac conditions in 2011.

Successful care transitions also require healthcare providers to appreciate the need for patients and their families to engage in their plans for post-discharge care, Weiss says. "I have been stunned to learn the kinds of medical tasks patients and families are now expected to conduct when they go home," she adds. "I hear them say, 'Nobody told us we would have to flush IVs.'"

Through another initiative, the foundation produced an interactive map that displays the percentage of patients readmitted to hospitals within 30 days of discharge; it has supported research that found improvements in nurses' work environments helped to reduce avoidable hospital readmissions. It also has produced a "Transitions to Better Care" video contest for hospitals, as well as a national publicity campaign about these issues called "Care About Your Care."

Visit our website for more information about patient care transitions.

The Robert Wood Johnson Foundation of Princeton, N.J., the country’s largest healthcare-focused philanthropy, has undertaken a number of initiatives to improve care transitions and reduce preventable hospital readmissions.

One of the key conclusions from these initiatives, says Anne Weiss, MPP, director of the foundation's Quality/Equality Health Care Team, is that hospitals and hospitalists can't do it alone. "Hospitals are now being held financially accountable for something they can't possibly control," Weiss says, referring to whether or not the discharged patient returns to the hospital within 30 days.

The foundation has mobilized broad community coalitions through its Aligning Forces for Quality campaign, bringing together healthcare providers, purchasers, consumers, and other stakeholders to improve care transitions. One such coalition, Better Health Greater Cleveland of Ohio, announced a 10.7% reduction in avoidable hospitalizations for common cardiac conditions in 2011.

Successful care transitions also require healthcare providers to appreciate the need for patients and their families to engage in their plans for post-discharge care, Weiss says. "I have been stunned to learn the kinds of medical tasks patients and families are now expected to conduct when they go home," she adds. "I hear them say, 'Nobody told us we would have to flush IVs.'"

Through another initiative, the foundation produced an interactive map that displays the percentage of patients readmitted to hospitals within 30 days of discharge; it has supported research that found improvements in nurses' work environments helped to reduce avoidable hospital readmissions. It also has produced a "Transitions to Better Care" video contest for hospitals, as well as a national publicity campaign about these issues called "Care About Your Care."

Visit our website for more information about patient care transitions.

The Robert Wood Johnson Foundation of Princeton, N.J., the country’s largest healthcare-focused philanthropy, has undertaken a number of initiatives to improve care transitions and reduce preventable hospital readmissions.

One of the key conclusions from these initiatives, says Anne Weiss, MPP, director of the foundation's Quality/Equality Health Care Team, is that hospitals and hospitalists can't do it alone. "Hospitals are now being held financially accountable for something they can't possibly control," Weiss says, referring to whether or not the discharged patient returns to the hospital within 30 days.

The foundation has mobilized broad community coalitions through its Aligning Forces for Quality campaign, bringing together healthcare providers, purchasers, consumers, and other stakeholders to improve care transitions. One such coalition, Better Health Greater Cleveland of Ohio, announced a 10.7% reduction in avoidable hospitalizations for common cardiac conditions in 2011.

Successful care transitions also require healthcare providers to appreciate the need for patients and their families to engage in their plans for post-discharge care, Weiss says. "I have been stunned to learn the kinds of medical tasks patients and families are now expected to conduct when they go home," she adds. "I hear them say, 'Nobody told us we would have to flush IVs.'"

Through another initiative, the foundation produced an interactive map that displays the percentage of patients readmitted to hospitals within 30 days of discharge; it has supported research that found improvements in nurses' work environments helped to reduce avoidable hospital readmissions. It also has produced a "Transitions to Better Care" video contest for hospitals, as well as a national publicity campaign about these issues called "Care About Your Care."

Visit our website for more information about patient care transitions.

Pediatricians in the emergency room are seeing more complicated head and neck infections, and more often. That's according to Dr. Keith Borg, emergency medicine physician and assistant professor at the Medical University of South Carolina. He gave some tips to choosing the best course of diagnosis and treatment.

Pediatricians in the emergency room are seeing more complicated head and neck infections, and more often. That's according to Dr. Keith Borg, emergency medicine physician and assistant professor at the Medical University of South Carolina. He gave some tips to choosing the best course of diagnosis and treatment.

Pediatricians in the emergency room are seeing more complicated head and neck infections, and more often. That's according to Dr. Keith Borg, emergency medicine physician and assistant professor at the Medical University of South Carolina. He gave some tips to choosing the best course of diagnosis and treatment.