Overuse of antibiotics is fueling antimicrobial resistance, posing a threat to people around the world and prompting increased attention to antibiotic stewardship practices. Good stewardship requires hospitals and clinicians to adopt coordinated interventions that focus on reducing inappropriate antibiotic prescribing while remaining focused on the health of patients.

Although it can seem overwhelming to physicians with busy workloads and sick patients to engage in these practices, not addressing the issue of responsible antibiotic prescribing is putting patients at risk.

“We know development of resistance is complicated,” says Arjun Srinivasan, MD, FSHEA, associate director for the CDC’s Healthcare Associated Infection Prevention Program and medical director of Get Smart for Healthcare in the CDC’s division of Healthcare Quality Promotion. Dr. Srinivasan is one of the authors of a recent CDC report on antibiotic prescribing practices across the U.S. “Nonetheless, we know that overuse of antibiotics leads to increases in resistance. We also know that if we can improve the way we prescribe them, we can reduce antibiotic resistance.”

The CDC recommends that hospitals adopt, at a minimum, the following antibiotic stewardship checklist:

• Commit leadership: Dedicate necessary human, financial, and information technology resources.
• Create accountability: Appoint a single leader responsible for program outcomes. Physicians have proven successful in this role.
• Provide drug expertise: Appoint a single pharmacist leader to support improved prescribing.
• Act: Take at least one prescribing improvement action, such as requiring reassessment within 48 hours to check drug choice, dose, and duration.
• Track: Monitor prescribing and antibiotic resistance patterns.
• Report: Regularly report to staff on prescribing and resistance patterns, as well as steps to improve.
• Educate: Offer education about antibiotic resistance and improving prescribing practices.
• Work with other healthcare facilities to prevent infections, transmission, and resistance.

These practices are not just the domain of infectious disease clinicians, either, says Neil Fishman, MD, chief patient safety officer and associate chief medical officer at the University of Pennsylvania Health System and past president of the Society for Healthcare Epidemiology of America. In 1992, Dr. Fishman helped establish an antibiotic stewardship program at Penn, working with infectious disease staff to identify and adopt best practices tailored to their needs.

Their efforts have shown promise in improving the health of their patients, he says, and many institutions that adopt stewardship programs typically see cost savings, too.

“These programs do usually end up decreasing drug costs but also increasing the quality of care,”

Dr. Fishman says. “If you can cut out 30% of unnecessary drugs, you cut drug costs. To me, that meets the true definition of value in healthcare.”

In one study that looked at stewardship-related cost reduction, primarily among larger healthcare settings, the average annual savings from reduced inappropriate antibiotic prescribing ranged from $200,000 to $900,000.

The recent CDC report, to which Dr. Srinivasan contributed, was published March 4 in Vital Signs. The study found that as many as a third of antibiotics prescribed are done so inappropriately. According to experts, hospitals and other healthcare institutions need to develop processes and standards to assist physicians in efforts to be responsible antibiotic prescribers.

“Sometimes, when you’re focusing on other issues, antibiotics are a bit of an afterthought,” says Scott Flanders, MD, FACP, MHM, professor of internal medicine and director of hospital medicine at University of Michigan Medical School in Ann Arbor.

“If there is not a checklist of processes [and] things are not accounted for in a systematic way, it doesn’t happen.”

Dr. Flanders and colleague Sanjay Saint, MD, MPH, the University of Michigan George Dock Collegiate professor of internal medicine and associate chief of medicine at the VA Ann Arbor Healthcare System, recently published an article in the Journal of the American Medical Association Internal Medicine in which they recommend the following:

• Antimicrobial stewardship programs, which aim to develop guidelines and implement programs that help optimize antibiotic use among hospitalized patients, should partner with front-line clinicians to tackle the problem.
• Clinicians should better document aspects of antibiotic use that can be shared with other providers caring for the same patient throughout his or her hospital stay and after discharge.
• Clinicians should take an “antibiotic time-out” after 48-72 hours of a patient’s use of antibiotics to reassess the use of these drugs.
• Treatment and its duration should be in line with evidence-based guidelines, and institutions should work to clearly identify appropriate treatment duration.
• Improved diagnostic tests should be available to physicians.
• Target diagnostic error by working to improve how physicians think when considering whether to provide antibiotics.
• Develop performance measures that highlight common conditions in which antibiotics are overprescribed, to shine a brighter light on the problem.

“I think we can make a lot of progress,” Dr. Flanders says. “The problem is complex; it developed over decades, and any solutions are unlikely to solve the problem immediately. But there are several examples of institutions and hospitals making significant inroads in a short period of time.” —KAT

Overuse of antibiotics is fueling antimicrobial resistance, posing a threat to people around the world and prompting increased attention to antibiotic stewardship practices. Good stewardship requires hospitals and clinicians to adopt coordinated interventions that focus on reducing inappropriate antibiotic prescribing while remaining focused on the health of patients.

Although it can seem overwhelming to physicians with busy workloads and sick patients to engage in these practices, not addressing the issue of responsible antibiotic prescribing is putting patients at risk.

“We know development of resistance is complicated,” says Arjun Srinivasan, MD, FSHEA, associate director for the CDC’s Healthcare Associated Infection Prevention Program and medical director of Get Smart for Healthcare in the CDC’s division of Healthcare Quality Promotion. Dr. Srinivasan is one of the authors of a recent CDC report on antibiotic prescribing practices across the U.S. “Nonetheless, we know that overuse of antibiotics leads to increases in resistance. We also know that if we can improve the way we prescribe them, we can reduce antibiotic resistance.”

The CDC recommends that hospitals adopt, at a minimum, the following antibiotic stewardship checklist:

• Commit leadership: Dedicate necessary human, financial, and information technology resources.
• Create accountability: Appoint a single leader responsible for program outcomes. Physicians have proven successful in this role.
• Provide drug expertise: Appoint a single pharmacist leader to support improved prescribing.
• Act: Take at least one prescribing improvement action, such as requiring reassessment within 48 hours to check drug choice, dose, and duration.
• Track: Monitor prescribing and antibiotic resistance patterns.
• Report: Regularly report to staff on prescribing and resistance patterns, as well as steps to improve.
• Educate: Offer education about antibiotic resistance and improving prescribing practices.
• Work with other healthcare facilities to prevent infections, transmission, and resistance.

These practices are not just the domain of infectious disease clinicians, either, says Neil Fishman, MD, chief patient safety officer and associate chief medical officer at the University of Pennsylvania Health System and past president of the Society for Healthcare Epidemiology of America. In 1992, Dr. Fishman helped establish an antibiotic stewardship program at Penn, working with infectious disease staff to identify and adopt best practices tailored to their needs.

Their efforts have shown promise in improving the health of their patients, he says, and many institutions that adopt stewardship programs typically see cost savings, too.

“These programs do usually end up decreasing drug costs but also increasing the quality of care,”

Dr. Fishman says. “If you can cut out 30% of unnecessary drugs, you cut drug costs. To me, that meets the true definition of value in healthcare.”

In one study that looked at stewardship-related cost reduction, primarily among larger healthcare settings, the average annual savings from reduced inappropriate antibiotic prescribing ranged from $200,000 to $900,000.

The recent CDC report, to which Dr. Srinivasan contributed, was published March 4 in Vital Signs. The study found that as many as a third of antibiotics prescribed are done so inappropriately. According to experts, hospitals and other healthcare institutions need to develop processes and standards to assist physicians in efforts to be responsible antibiotic prescribers.

“Sometimes, when you’re focusing on other issues, antibiotics are a bit of an afterthought,” says Scott Flanders, MD, FACP, MHM, professor of internal medicine and director of hospital medicine at University of Michigan Medical School in Ann Arbor.

“If there is not a checklist of processes [and] things are not accounted for in a systematic way, it doesn’t happen.”

Dr. Flanders and colleague Sanjay Saint, MD, MPH, the University of Michigan George Dock Collegiate professor of internal medicine and associate chief of medicine at the VA Ann Arbor Healthcare System, recently published an article in the Journal of the American Medical Association Internal Medicine in which they recommend the following:

• Antimicrobial stewardship programs, which aim to develop guidelines and implement programs that help optimize antibiotic use among hospitalized patients, should partner with front-line clinicians to tackle the problem.
• Clinicians should better document aspects of antibiotic use that can be shared with other providers caring for the same patient throughout his or her hospital stay and after discharge.
• Clinicians should take an “antibiotic time-out” after 48-72 hours of a patient’s use of antibiotics to reassess the use of these drugs.
• Treatment and its duration should be in line with evidence-based guidelines, and institutions should work to clearly identify appropriate treatment duration.
• Improved diagnostic tests should be available to physicians.
• Target diagnostic error by working to improve how physicians think when considering whether to provide antibiotics.
• Develop performance measures that highlight common conditions in which antibiotics are overprescribed, to shine a brighter light on the problem.

“I think we can make a lot of progress,” Dr. Flanders says. “The problem is complex; it developed over decades, and any solutions are unlikely to solve the problem immediately. But there are several examples of institutions and hospitals making significant inroads in a short period of time.” —KAT

Overuse of antibiotics is fueling antimicrobial resistance, posing a threat to people around the world and prompting increased attention to antibiotic stewardship practices. Good stewardship requires hospitals and clinicians to adopt coordinated interventions that focus on reducing inappropriate antibiotic prescribing while remaining focused on the health of patients.

Although it can seem overwhelming to physicians with busy workloads and sick patients to engage in these practices, not addressing the issue of responsible antibiotic prescribing is putting patients at risk.

“We know development of resistance is complicated,” says Arjun Srinivasan, MD, FSHEA, associate director for the CDC’s Healthcare Associated Infection Prevention Program and medical director of Get Smart for Healthcare in the CDC’s division of Healthcare Quality Promotion. Dr. Srinivasan is one of the authors of a recent CDC report on antibiotic prescribing practices across the U.S. “Nonetheless, we know that overuse of antibiotics leads to increases in resistance. We also know that if we can improve the way we prescribe them, we can reduce antibiotic resistance.”

The CDC recommends that hospitals adopt, at a minimum, the following antibiotic stewardship checklist:

• Commit leadership: Dedicate necessary human, financial, and information technology resources.
• Create accountability: Appoint a single leader responsible for program outcomes. Physicians have proven successful in this role.
• Provide drug expertise: Appoint a single pharmacist leader to support improved prescribing.
• Act: Take at least one prescribing improvement action, such as requiring reassessment within 48 hours to check drug choice, dose, and duration.
• Track: Monitor prescribing and antibiotic resistance patterns.
• Report: Regularly report to staff on prescribing and resistance patterns, as well as steps to improve.
• Educate: Offer education about antibiotic resistance and improving prescribing practices.
• Work with other healthcare facilities to prevent infections, transmission, and resistance.

These practices are not just the domain of infectious disease clinicians, either, says Neil Fishman, MD, chief patient safety officer and associate chief medical officer at the University of Pennsylvania Health System and past president of the Society for Healthcare Epidemiology of America. In 1992, Dr. Fishman helped establish an antibiotic stewardship program at Penn, working with infectious disease staff to identify and adopt best practices tailored to their needs.

Their efforts have shown promise in improving the health of their patients, he says, and many institutions that adopt stewardship programs typically see cost savings, too.

“These programs do usually end up decreasing drug costs but also increasing the quality of care,”

Dr. Fishman says. “If you can cut out 30% of unnecessary drugs, you cut drug costs. To me, that meets the true definition of value in healthcare.”

In one study that looked at stewardship-related cost reduction, primarily among larger healthcare settings, the average annual savings from reduced inappropriate antibiotic prescribing ranged from $200,000 to $900,000.

The recent CDC report, to which Dr. Srinivasan contributed, was published March 4 in Vital Signs. The study found that as many as a third of antibiotics prescribed are done so inappropriately. According to experts, hospitals and other healthcare institutions need to develop processes and standards to assist physicians in efforts to be responsible antibiotic prescribers.

“Sometimes, when you’re focusing on other issues, antibiotics are a bit of an afterthought,” says Scott Flanders, MD, FACP, MHM, professor of internal medicine and director of hospital medicine at University of Michigan Medical School in Ann Arbor.

“If there is not a checklist of processes [and] things are not accounted for in a systematic way, it doesn’t happen.”

Dr. Flanders and colleague Sanjay Saint, MD, MPH, the University of Michigan George Dock Collegiate professor of internal medicine and associate chief of medicine at the VA Ann Arbor Healthcare System, recently published an article in the Journal of the American Medical Association Internal Medicine in which they recommend the following:

• Antimicrobial stewardship programs, which aim to develop guidelines and implement programs that help optimize antibiotic use among hospitalized patients, should partner with front-line clinicians to tackle the problem.
• Clinicians should better document aspects of antibiotic use that can be shared with other providers caring for the same patient throughout his or her hospital stay and after discharge.
• Clinicians should take an “antibiotic time-out” after 48-72 hours of a patient’s use of antibiotics to reassess the use of these drugs.
• Treatment and its duration should be in line with evidence-based guidelines, and institutions should work to clearly identify appropriate treatment duration.
• Improved diagnostic tests should be available to physicians.
• Target diagnostic error by working to improve how physicians think when considering whether to provide antibiotics.
• Develop performance measures that highlight common conditions in which antibiotics are overprescribed, to shine a brighter light on the problem.

“I think we can make a lot of progress,” Dr. Flanders says. “The problem is complex; it developed over decades, and any solutions are unlikely to solve the problem immediately. But there are several examples of institutions and hospitals making significant inroads in a short period of time.” —KAT

A recent CDC study found that nearly a third of antibiotics might be inappropriately prescribed.¹ The report also found wide variation in antibiotic prescribing practices for patients in similar treatment areas in hospitals across the country.

Across the globe, antibiotic resistance has become a daunting threat. Some public health officials have labeled it a crisis, and improper prescribing and use of antibiotics is at least partly to blame, experts say.

“We’re dangerously close to a pre-antibiotic era where we don’t have antibiotics to treat common infections,” says Neil Fishman, MD, chief patient safety officer and associate chief medical officer at the University of Pennsylvania Health System and past president of the Society for Healthcare Epidemiology of America. “We are seeing more and more infections, usually hospital-based, caused by bacterial resistance to most, if not all, of the antibiotics that we have.”

It’s an issue hospitalists around the country are championing.

“I think for a long time there’s been a misperception that antibiotic stewardship is at odds with hospitalists, who are managing very busy patient loads and managing inpatient prescribing,” says Arjun Srinivasan, MD, FSHEA, associate director for the CDC’s Healthcare Associated Infection Prevention Program and medical director of Get Smart for Healthcare in the division of Healthcare Quality Promotion at the CDC. Dr. Srinivasan is one of the authors of the new CDC study.

But “they have taken that ball and run with it,” says Dr. Srinivasan, who has worked with the Society of Hospital Medicine to address antibiotic resistance issues.

The goals of the study, published in the CDC’s Vital Signs on March 4, 2014, were to evaluate the extent and rationale for the prescribing of antibiotics in U.S. hospitals, while demonstrating opportunities for improvement in prescribing practices.

Study authors analyzed data from the Truven Health MarketScan Hospital Drug Database and the CDC’s Emerging Infection Program and, using a model based on the data, demonstrated that a 30% reduction in broad-spectrum antibiotics use would decrease Clostridium difficile infection (CDI) by 26%. Overall antibiotic use would drop by 5%.

According to the CDC, antibiotics are among the most frequent causes of adverse drug events among hospitalized patients in the U.S., and complications like CDI can be deadly. In fact, 250,000 hospitalized patients are infected with CDI each year, resulting in 14,000 deaths.

“We’re really at a critical juncture in healthcare now,” Dr. Fishman says. “The field of stewardship has evolved mainly in academic tertiary care settings. The CDC report is timely because it highlights the necessity of making sure antibiotics are used appropriately in all healthcare settings.”

Take a Break

One of the ways in which hospitalists have addressed the need for more appropriate antibiotic prescribing in their institutions is the practice of an “antibiotic time-out.”

“After some point, when the dust settles at about 48-72 hours, you can evaluate the patient’s progress, evaluate their studies, [and] you may have culture results,” says Scott Flanders, MD, FACP, MHM, professor of internal medicine and director of hospital medicine at the University of Michigan Medical School in Ann Arbor. At that point, physicians can decide whether to maintain a patient on the original antibiotic, alter the duration of treatment, or take them off the treatment altogether.

Dr. Flanders and a colleague published an editorial in the Journal of the American Medical Association Internal Medicine that coincided with the CDC report.² A 2007 study published in Clinical Infectious Diseases found that the choice of antibiotic agent or duration of treatment can be incorrect in as many as half of all cases in which antibiotics are prescribed.³

Dr. Flanders, a past president of SHM who has worked extensively with the CDC and the Institute for Healthcare Improvement, was behind the development of the time-out strategy. Dr. Srinivasan says the clinical utility of the method was “eye-opening.”

The strategy, which has taken hold among hospital groups the CDC has worked with, has demonstrated that stewardship and patient management are not at odds, Dr. Srinivasan says. Despite patient sign-outs and hand-offs, the time-out strategy allows any clinician to track a patient’s antibiotic status and reevaluate the treatment plan.

Having a process is critical to more responsible prescribing practices, Dr. Flanders says. He attributes much of the variability in antibiotics prescribing among similar departments at hospitals across the country to a lack of standards, though he noted that variability in patient populations undoubtedly plays a role.

Lack of Stats

The CDC report showed up to a threefold difference in the number of antibiotics prescribed to patients in similar hospital settings at hospitals across the country. The reasons for this are not known, Dr. Fishman says.

“The main reason we don’t know is we don’t have a good mechanism in the U.S. right now to monitor antibiotics use,” he explains. “We don’t have a way for healthcare facilities to benchmark their use.”

Without good strategies to monitor and develop more responsible antibiotics prescription practices, Dr. Flanders believes many physicians find themselves trapped by the “chagrin” of not prescribing.

“Patients often enter the hospital without a clear diagnosis,” he says. “They are quite ill. They may have a serious bacterial infection, and, in diagnosing them, we can’t guess wrong and make the decision to withhold antibiotics, only to find out later the patient is infected.

“We know delays increase mortality, and that’s not an acceptable option.”

Patients often enter the hospital without a clear diagnosis. They are quite ill. They may have a serious bacterial infection, and, in diagnosing them, we can’t guess wrong and make the decision to withhold antibiotics, only to find out later the patient is infected.

 

—Scott Flanders, MD, FACP, MHM, professor of internal medicine, director of hospital medicine, University of Michigan Medical School, Ann Arbor, past president, SHM

Beyond the Bedside

Many physicians fail to consider the bigger societal implications when prescribing antibiotics for sick patients in their charge, because their responsibility is, first and foremost, to that individual. But, Dr. Srinivasan says, “good antibiotic stewardship is beneficial to the patient lying in the bed in front of you, because every day we are confronted with C. diff. infections, adverse drug events, all of these issues.”

Strategies and processes help hospitalists make the best decision for their patients at the time they require care, while providing room for adaptation and the improvements that serve all patients.

Some institutions use interventions like prospective audit and feedback monitoring to help physicians become more responsible antibiotic prescribers, says Dr. Fishman, who worked with infectious disease specialists at the University of Pennsylvania in the early 1990s to develop a stewardship program there.

“In our institution, we see better outcomes—lower complications—usually associated with a decreased length of stay, at least in the ICU for critically ill patients—and increased cure rates,” he says.

Stewardship efforts take investment on the part of the hospital. Dr. Fishman cited a recent study at the Children’s Hospital of Pennsylvania that looked at whether a particular education strategy the hospital implemented actually led to improvements.⁴

“It was successful in intervening in this problem [of inappropriate prescribing] in pediatricians, but it did take ongoing education of both healthcare providers and patients,” he says, noting that large financial and time investments are necessary for the ongoing training and follow-up that is necessary.

And patients need to be educated, too.

“It takes a minute to write that prescription and probably 15 or 20 minutes not to write it,” Dr. Fishman says. “We need to educate patients about potential complications of antibiotics use, as well as the signs and symptoms of infection.”

The CDC report is a call to action for all healthcare providers to consider how they can become better antibiotic stewards. There are very few new antibiotics on the market and little in the pipeline. All providers must do what they can to preserve the antibiotics we currently have, Dr. Fishman says.

“There is opportunity, and I think hospitalists are up to the challenge,” Dr. Flanders says. “They are doing lots of work to improve quality across lots of domains in their hospitals. I think this is an area where attention is deserved.”

Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

1. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Vital signs: improving antibiotic use among hospitalized patients. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6309a4.htm?s_cid=mm6309a4_w. Accessed August 31, 2014.
2. Flanders SA, Saint S. Why does antrimicrobial overuse in hospitalized patients persist? JAMA Internal Medicine online. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1838720. Accessed August 31, 2014.
3. Dellit TH, Owens RC, McGowan JE, et al. Clinical Infectious Diseases online. Available at: http://cid.oxfordjournals.org/content/44/2/159.full. Accessed August 31, 2014.
4. Gerber JS, Prasad PA, Fiks A, et al. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians. JAMA. 2013;309(22):2345-2352.

A recent CDC study found that nearly a third of antibiotics might be inappropriately prescribed.¹ The report also found wide variation in antibiotic prescribing practices for patients in similar treatment areas in hospitals across the country.

Across the globe, antibiotic resistance has become a daunting threat. Some public health officials have labeled it a crisis, and improper prescribing and use of antibiotics is at least partly to blame, experts say.

“We’re dangerously close to a pre-antibiotic era where we don’t have antibiotics to treat common infections,” says Neil Fishman, MD, chief patient safety officer and associate chief medical officer at the University of Pennsylvania Health System and past president of the Society for Healthcare Epidemiology of America. “We are seeing more and more infections, usually hospital-based, caused by bacterial resistance to most, if not all, of the antibiotics that we have.”

It’s an issue hospitalists around the country are championing.

“I think for a long time there’s been a misperception that antibiotic stewardship is at odds with hospitalists, who are managing very busy patient loads and managing inpatient prescribing,” says Arjun Srinivasan, MD, FSHEA, associate director for the CDC’s Healthcare Associated Infection Prevention Program and medical director of Get Smart for Healthcare in the division of Healthcare Quality Promotion at the CDC. Dr. Srinivasan is one of the authors of the new CDC study.

But “they have taken that ball and run with it,” says Dr. Srinivasan, who has worked with the Society of Hospital Medicine to address antibiotic resistance issues.

The goals of the study, published in the CDC’s Vital Signs on March 4, 2014, were to evaluate the extent and rationale for the prescribing of antibiotics in U.S. hospitals, while demonstrating opportunities for improvement in prescribing practices.

Study authors analyzed data from the Truven Health MarketScan Hospital Drug Database and the CDC’s Emerging Infection Program and, using a model based on the data, demonstrated that a 30% reduction in broad-spectrum antibiotics use would decrease Clostridium difficile infection (CDI) by 26%. Overall antibiotic use would drop by 5%.

According to the CDC, antibiotics are among the most frequent causes of adverse drug events among hospitalized patients in the U.S., and complications like CDI can be deadly. In fact, 250,000 hospitalized patients are infected with CDI each year, resulting in 14,000 deaths.

“We’re really at a critical juncture in healthcare now,” Dr. Fishman says. “The field of stewardship has evolved mainly in academic tertiary care settings. The CDC report is timely because it highlights the necessity of making sure antibiotics are used appropriately in all healthcare settings.”

Take a Break

One of the ways in which hospitalists have addressed the need for more appropriate antibiotic prescribing in their institutions is the practice of an “antibiotic time-out.”

“After some point, when the dust settles at about 48-72 hours, you can evaluate the patient’s progress, evaluate their studies, [and] you may have culture results,” says Scott Flanders, MD, FACP, MHM, professor of internal medicine and director of hospital medicine at the University of Michigan Medical School in Ann Arbor. At that point, physicians can decide whether to maintain a patient on the original antibiotic, alter the duration of treatment, or take them off the treatment altogether.

Dr. Flanders and a colleague published an editorial in the Journal of the American Medical Association Internal Medicine that coincided with the CDC report.² A 2007 study published in Clinical Infectious Diseases found that the choice of antibiotic agent or duration of treatment can be incorrect in as many as half of all cases in which antibiotics are prescribed.³

Dr. Flanders, a past president of SHM who has worked extensively with the CDC and the Institute for Healthcare Improvement, was behind the development of the time-out strategy. Dr. Srinivasan says the clinical utility of the method was “eye-opening.”

The strategy, which has taken hold among hospital groups the CDC has worked with, has demonstrated that stewardship and patient management are not at odds, Dr. Srinivasan says. Despite patient sign-outs and hand-offs, the time-out strategy allows any clinician to track a patient’s antibiotic status and reevaluate the treatment plan.

Having a process is critical to more responsible prescribing practices, Dr. Flanders says. He attributes much of the variability in antibiotics prescribing among similar departments at hospitals across the country to a lack of standards, though he noted that variability in patient populations undoubtedly plays a role.

Lack of Stats

The CDC report showed up to a threefold difference in the number of antibiotics prescribed to patients in similar hospital settings at hospitals across the country. The reasons for this are not known, Dr. Fishman says.

“The main reason we don’t know is we don’t have a good mechanism in the U.S. right now to monitor antibiotics use,” he explains. “We don’t have a way for healthcare facilities to benchmark their use.”

Without good strategies to monitor and develop more responsible antibiotics prescription practices, Dr. Flanders believes many physicians find themselves trapped by the “chagrin” of not prescribing.

“Patients often enter the hospital without a clear diagnosis,” he says. “They are quite ill. They may have a serious bacterial infection, and, in diagnosing them, we can’t guess wrong and make the decision to withhold antibiotics, only to find out later the patient is infected.

“We know delays increase mortality, and that’s not an acceptable option.”

Patients often enter the hospital without a clear diagnosis. They are quite ill. They may have a serious bacterial infection, and, in diagnosing them, we can’t guess wrong and make the decision to withhold antibiotics, only to find out later the patient is infected.

 

—Scott Flanders, MD, FACP, MHM, professor of internal medicine, director of hospital medicine, University of Michigan Medical School, Ann Arbor, past president, SHM

Beyond the Bedside

Many physicians fail to consider the bigger societal implications when prescribing antibiotics for sick patients in their charge, because their responsibility is, first and foremost, to that individual. But, Dr. Srinivasan says, “good antibiotic stewardship is beneficial to the patient lying in the bed in front of you, because every day we are confronted with C. diff. infections, adverse drug events, all of these issues.”

Strategies and processes help hospitalists make the best decision for their patients at the time they require care, while providing room for adaptation and the improvements that serve all patients.

Some institutions use interventions like prospective audit and feedback monitoring to help physicians become more responsible antibiotic prescribers, says Dr. Fishman, who worked with infectious disease specialists at the University of Pennsylvania in the early 1990s to develop a stewardship program there.

“In our institution, we see better outcomes—lower complications—usually associated with a decreased length of stay, at least in the ICU for critically ill patients—and increased cure rates,” he says.

Stewardship efforts take investment on the part of the hospital. Dr. Fishman cited a recent study at the Children’s Hospital of Pennsylvania that looked at whether a particular education strategy the hospital implemented actually led to improvements.⁴

“It was successful in intervening in this problem [of inappropriate prescribing] in pediatricians, but it did take ongoing education of both healthcare providers and patients,” he says, noting that large financial and time investments are necessary for the ongoing training and follow-up that is necessary.

And patients need to be educated, too.

“It takes a minute to write that prescription and probably 15 or 20 minutes not to write it,” Dr. Fishman says. “We need to educate patients about potential complications of antibiotics use, as well as the signs and symptoms of infection.”

The CDC report is a call to action for all healthcare providers to consider how they can become better antibiotic stewards. There are very few new antibiotics on the market and little in the pipeline. All providers must do what they can to preserve the antibiotics we currently have, Dr. Fishman says.

“There is opportunity, and I think hospitalists are up to the challenge,” Dr. Flanders says. “They are doing lots of work to improve quality across lots of domains in their hospitals. I think this is an area where attention is deserved.”

Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

1. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Vital signs: improving antibiotic use among hospitalized patients. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6309a4.htm?s_cid=mm6309a4_w. Accessed August 31, 2014.
2. Flanders SA, Saint S. Why does antrimicrobial overuse in hospitalized patients persist? JAMA Internal Medicine online. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1838720. Accessed August 31, 2014.
3. Dellit TH, Owens RC, McGowan JE, et al. Clinical Infectious Diseases online. Available at: http://cid.oxfordjournals.org/content/44/2/159.full. Accessed August 31, 2014.
4. Gerber JS, Prasad PA, Fiks A, et al. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians. JAMA. 2013;309(22):2345-2352.

A recent CDC study found that nearly a third of antibiotics might be inappropriately prescribed.¹ The report also found wide variation in antibiotic prescribing practices for patients in similar treatment areas in hospitals across the country.

Across the globe, antibiotic resistance has become a daunting threat. Some public health officials have labeled it a crisis, and improper prescribing and use of antibiotics is at least partly to blame, experts say.

“We’re dangerously close to a pre-antibiotic era where we don’t have antibiotics to treat common infections,” says Neil Fishman, MD, chief patient safety officer and associate chief medical officer at the University of Pennsylvania Health System and past president of the Society for Healthcare Epidemiology of America. “We are seeing more and more infections, usually hospital-based, caused by bacterial resistance to most, if not all, of the antibiotics that we have.”

It’s an issue hospitalists around the country are championing.

“I think for a long time there’s been a misperception that antibiotic stewardship is at odds with hospitalists, who are managing very busy patient loads and managing inpatient prescribing,” says Arjun Srinivasan, MD, FSHEA, associate director for the CDC’s Healthcare Associated Infection Prevention Program and medical director of Get Smart for Healthcare in the division of Healthcare Quality Promotion at the CDC. Dr. Srinivasan is one of the authors of the new CDC study.

But “they have taken that ball and run with it,” says Dr. Srinivasan, who has worked with the Society of Hospital Medicine to address antibiotic resistance issues.

The goals of the study, published in the CDC’s Vital Signs on March 4, 2014, were to evaluate the extent and rationale for the prescribing of antibiotics in U.S. hospitals, while demonstrating opportunities for improvement in prescribing practices.

Study authors analyzed data from the Truven Health MarketScan Hospital Drug Database and the CDC’s Emerging Infection Program and, using a model based on the data, demonstrated that a 30% reduction in broad-spectrum antibiotics use would decrease Clostridium difficile infection (CDI) by 26%. Overall antibiotic use would drop by 5%.

According to the CDC, antibiotics are among the most frequent causes of adverse drug events among hospitalized patients in the U.S., and complications like CDI can be deadly. In fact, 250,000 hospitalized patients are infected with CDI each year, resulting in 14,000 deaths.

“We’re really at a critical juncture in healthcare now,” Dr. Fishman says. “The field of stewardship has evolved mainly in academic tertiary care settings. The CDC report is timely because it highlights the necessity of making sure antibiotics are used appropriately in all healthcare settings.”

Take a Break

One of the ways in which hospitalists have addressed the need for more appropriate antibiotic prescribing in their institutions is the practice of an “antibiotic time-out.”

“After some point, when the dust settles at about 48-72 hours, you can evaluate the patient’s progress, evaluate their studies, [and] you may have culture results,” says Scott Flanders, MD, FACP, MHM, professor of internal medicine and director of hospital medicine at the University of Michigan Medical School in Ann Arbor. At that point, physicians can decide whether to maintain a patient on the original antibiotic, alter the duration of treatment, or take them off the treatment altogether.

Dr. Flanders and a colleague published an editorial in the Journal of the American Medical Association Internal Medicine that coincided with the CDC report.² A 2007 study published in Clinical Infectious Diseases found that the choice of antibiotic agent or duration of treatment can be incorrect in as many as half of all cases in which antibiotics are prescribed.³

Dr. Flanders, a past president of SHM who has worked extensively with the CDC and the Institute for Healthcare Improvement, was behind the development of the time-out strategy. Dr. Srinivasan says the clinical utility of the method was “eye-opening.”

The strategy, which has taken hold among hospital groups the CDC has worked with, has demonstrated that stewardship and patient management are not at odds, Dr. Srinivasan says. Despite patient sign-outs and hand-offs, the time-out strategy allows any clinician to track a patient’s antibiotic status and reevaluate the treatment plan.

Having a process is critical to more responsible prescribing practices, Dr. Flanders says. He attributes much of the variability in antibiotics prescribing among similar departments at hospitals across the country to a lack of standards, though he noted that variability in patient populations undoubtedly plays a role.

Lack of Stats

The CDC report showed up to a threefold difference in the number of antibiotics prescribed to patients in similar hospital settings at hospitals across the country. The reasons for this are not known, Dr. Fishman says.

“The main reason we don’t know is we don’t have a good mechanism in the U.S. right now to monitor antibiotics use,” he explains. “We don’t have a way for healthcare facilities to benchmark their use.”

Without good strategies to monitor and develop more responsible antibiotics prescription practices, Dr. Flanders believes many physicians find themselves trapped by the “chagrin” of not prescribing.

“Patients often enter the hospital without a clear diagnosis,” he says. “They are quite ill. They may have a serious bacterial infection, and, in diagnosing them, we can’t guess wrong and make the decision to withhold antibiotics, only to find out later the patient is infected.

“We know delays increase mortality, and that’s not an acceptable option.”

Patients often enter the hospital without a clear diagnosis. They are quite ill. They may have a serious bacterial infection, and, in diagnosing them, we can’t guess wrong and make the decision to withhold antibiotics, only to find out later the patient is infected.

 

—Scott Flanders, MD, FACP, MHM, professor of internal medicine, director of hospital medicine, University of Michigan Medical School, Ann Arbor, past president, SHM

Beyond the Bedside

Many physicians fail to consider the bigger societal implications when prescribing antibiotics for sick patients in their charge, because their responsibility is, first and foremost, to that individual. But, Dr. Srinivasan says, “good antibiotic stewardship is beneficial to the patient lying in the bed in front of you, because every day we are confronted with C. diff. infections, adverse drug events, all of these issues.”

Strategies and processes help hospitalists make the best decision for their patients at the time they require care, while providing room for adaptation and the improvements that serve all patients.

Some institutions use interventions like prospective audit and feedback monitoring to help physicians become more responsible antibiotic prescribers, says Dr. Fishman, who worked with infectious disease specialists at the University of Pennsylvania in the early 1990s to develop a stewardship program there.

“In our institution, we see better outcomes—lower complications—usually associated with a decreased length of stay, at least in the ICU for critically ill patients—and increased cure rates,” he says.

Stewardship efforts take investment on the part of the hospital. Dr. Fishman cited a recent study at the Children’s Hospital of Pennsylvania that looked at whether a particular education strategy the hospital implemented actually led to improvements.⁴

“It was successful in intervening in this problem [of inappropriate prescribing] in pediatricians, but it did take ongoing education of both healthcare providers and patients,” he says, noting that large financial and time investments are necessary for the ongoing training and follow-up that is necessary.

And patients need to be educated, too.

“It takes a minute to write that prescription and probably 15 or 20 minutes not to write it,” Dr. Fishman says. “We need to educate patients about potential complications of antibiotics use, as well as the signs and symptoms of infection.”

The CDC report is a call to action for all healthcare providers to consider how they can become better antibiotic stewards. There are very few new antibiotics on the market and little in the pipeline. All providers must do what they can to preserve the antibiotics we currently have, Dr. Fishman says.

“There is opportunity, and I think hospitalists are up to the challenge,” Dr. Flanders says. “They are doing lots of work to improve quality across lots of domains in their hospitals. I think this is an area where attention is deserved.”

Kelly April Tyrrell is a freelance writer in Madison, Wis.

References

1. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Vital signs: improving antibiotic use among hospitalized patients. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6309a4.htm?s_cid=mm6309a4_w. Accessed August 31, 2014.
2. Flanders SA, Saint S. Why does antrimicrobial overuse in hospitalized patients persist? JAMA Internal Medicine online. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1838720. Accessed August 31, 2014.
3. Dellit TH, Owens RC, McGowan JE, et al. Clinical Infectious Diseases online. Available at: http://cid.oxfordjournals.org/content/44/2/159.full. Accessed August 31, 2014.
4. Gerber JS, Prasad PA, Fiks A, et al. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians. JAMA. 2013;309(22):2345-2352.

The highlight of SHM’s biennial State of Hospital Medicine (SOHM) report is how much hospitalists earn. So it’s to be expected that rank-and-file practitioners and group leaders who read this year’s edition will first notice that median compensation for adult hospitalists rose 8% to $252,996 in 2013, according to data from the Medical Group Management Association (MGMA). The compensation data from MGMA is wrapped into the SOHM 2014 report this year.

But to stop there would be a wasted opportunity, says William “Tex” Landis, MD, FHM, medical director of Wellspan Hospitalists in York, Pa., and a member and former chair of SHM’s Practice Analysis Committee. Along with compensation, the report (available at www.hospitalmedicine.org/survey) delves into scheduling, productivity, staffing, how compensation is broken down, practice models, and dozens of other topics that hospital medicine group (HMG) leaders will find useful.

“Scope of services is a big one,” Dr. Landis adds. “What other things are hospital medicine groups around the country being held responsible for? Are we morphing into universal admitters? How involved in palliative care are we? What about transitions of care? How many hospital medicine groups are becoming involved in managing nursing home patients? What’s the relationship with surgical co-management? How much ICU work are we doing?”

Dr. Landis’ laundry list of unanswered questions might seem daunting, but that’s the point of the research SHM has been collecting and reporting for years. The society surveyed 499 groups, representing some 6,300 providers, to give the specialty’s most detailed list of most popular, if not best, practices.

“It has the usual limitations of any survey; however, it is the very best survey, quantity and quality, of hospital medicine groups,” Dr. Landis says. “And so it becomes the best source of information to make important decisions about resourcing and operating hospital medicine groups.”

Earnings Up

And, like it or not, compensation for providers typically is a HMG’s largest budget line. In that regard, the specialty appears to be doing well. Median compensation for adult hospitalists rose to a record high last year, according to the MGMA Physician Compensation and Production Survey: 2014 Report Based on 2013 Data. Half of respondents work in practices owned by hospitals/integrated delivery systems, down from 56% in SOHM 2012.

Although hospitalists in the South region continue to earn the most (median compensation $258,020, essentially static with the $258,793 figure reported in 2012), the region was the only one to report a decrease (see Table 1 for historical data). The largest percentage jump (11.8%) was for hospitalists in the West region ($249,894). Hospitalists in the Midwest saw a 10% increase ($261,868), while those in the East had both the smallest increase (4.8%) and the lowest median compensation ($238,676).

It will be interesting to see what the data shows over the next three or four years if stipends, as we believe we are seeing, come under pressure and hospitals are doing more outsourcing.

—R. Jeffrey Taylor, president and COO, IPC The Hospitalist Co., North Hollywood, Calif.

Part of the compensation increase is tied to upward pressure on productivity. Nationwide, median relative value units (RVUs) rose 3.3%, to 4,297 from 4,159. Median collection-to-work RVUs ticked up 6.8%, to 51.5 from 48.21 (see Table 2 for regional breakdowns). Production (10.5%) and performance (6.6%) are also slightly larger portions of mean compensation than they were in 2012, a figure many expect to increase further in future reports. The report also noted that academic/university hospitalists receive more in base pay, while hospitalists in private practice receive less.

Compensation and work volume will be intrinsically tied in the coming years, says R. Jeffrey Taylor, president and chief operating officer of IPC The Hospitalist Co., based in North Hollywood, Calif. And if pay outpaces productivity, “then it’s a bit concerning for the system at large,” he says.

“Particularly for whoever is subsidizing that shortfall, whether it’s a hospital employing doctors or an outsourced group employing the doctors but requiring a large subsidy from the hospital because the doctors are not seeing enough patient flow to pay their salary and benefits,” Taylor says.

More than 89% of HMGs rely on their host hospitals for financial support, according to the new data. The median support is $156,063 per full-time employee (FTE), which would total $1 million at just over seven FTEs. As healthcare reform progresses and hospitals’ budgets are increasingly burdened, Taylor says that pressure for hospitalists to generate enough revenue to cover their own salaries will grow. That sets up a likely showdown between hospitalists and their institutions; SOHM 2014 reported that just 6% of HMGs received enough income from professional fee revenue to cover expenses.

click for large version

click for large version

“Some productivity element in compensation plans, we believe, and I believe personally, is important,” Taylor says, later adding: “We already have a physician shortage and a shortage of people to see all these patients. It’s exacerbated by two things: lack of productivity and shift-model scheduling.”

To wit, IPC pays lower base salaries but provides bonuses tied to productivity and quality metrics. The average IPC hospitalist, Taylor says, earned more than $290,000 last year, nearly 15% above the median figure in the SOHM report. Between 30%-40% of that compensation, however, was earned via bonus tied to both “productivity and clinical achievement.”

Taylor, an outspoken advocate for moving away from the seven-on/seven-off scheduling model popular throughout hospital medicine, ties some of his doctors’ higher compensation to his firm’s preference for avoiding that schedule. But he’s not surprised the new report shows that 53.8% of responding HMGs use the model, up from 41.9% in 2012.

“It will be interesting to see what the data shows over the next three or four years,” he says, “if stipends, as we believe we are seeing, come under pressure and hospitals are doing more outsourcing.”

click for large version

The PCP Link

Industry leaders use the information in the biennial reports to gauge where the specialty stands in the overall healthcare spectrum. Dea Robinson, MA, FACMPE, CPC, director of consulting for MGMA Health Care Consulting Group, says that the growth of hospital medicine (HM) compensation is tied to that of primary care physicians (PCPs).

“I don’t think we can look at hospitalists without looking at primary care, because it’s really an extension of primary care,” says Robinson, a member of SHM’s Practice Management Committee. “As primary care compensation increases, hospitalists’ compensation might increase as well. And with the focus on patient-centered medical homes, which is basically primary care centered, that might very well be part of the driver in the future of seeing hospitalists grow.”

While facing a well-known physician shortage, primary care’s compensation growth also lags behind HM. For example, median compensation for hospitalists rose 8%; it increased 5.5% for PCPs.

“When it comes to growth of the two individual industries, I think they are connected in some way,” she adds. “But in terms of the compensation, now we’re starting to see different codes that hospitalists are able to use but that primary care used to use exclusively. So, you really see more of an extension and a collaboration between true primary care and hospitalists.”

Bryan Weiss, MBA, FHM, managing director of the consulting services practice at Irving, Texas-based MedSynergies, agrees that hospitalists and PCPs are connected. He believes the higher compensation figures are a sign of how young HM is as a specialty. He fears compensation “is probably growing too fast.”

“This takes me back to the 1990s, with the private [physician practice management]-type model, where it just grew so fast that the bottom fell out,” says Weiss, a member of Team Hospitalist. “Not that I think the bottom is going to fall out of hospital medicine, but a lot of this is reminiscent of that, and I think there’s going to be a ceiling, or at least a slowing down.”

We’re not talking about disenfranchising healthcare or providers. We’re talking about more reasonable growth and about, more than anything, paying for the right things.

—Stuart Guterman, vice president, Medicare and cost control, The Commonwealth Fund

In contrast, one good sign for the specialty’s compensation and financial support is that “hospitals are still the hub of the healthcare system and need to be an important part of healthcare reform,” says Stuart Guterman, vice president for Medicare and cost control at The Commonwealth Fund, a New York foundation focused on improving healthcare delivery. Guterman says that while President Obama and congressional leaders are looking to cut the rate of growth in healthcare spending, the figure is already so high that there should still be plenty of resources in the system.

“If you took today’s spending and you increased it at the [GDP] growth rate for 10 years, I think we’re talking about something over $30 trillion over 10 years,” Guterman says. “And remember that we’re starting at a point that’s over 50% higher than any other country in the world. So, we’re talking about plenty of resources still in this healthcare system.”

With accountable care organizations, the specter of bundled payments, and penalties for readmitted patients, Guterman says that the pending issue for the specialty isn’t whether hospitalists—or other hospital-based practitioners—are going to get paid more or less, but rather what their compensation will be based on.

“Things like better coordination of care, sending the patients to the right place, having the patients in the right place, having them in the hospital if they need to be, or keeping them out of the hospital if they don’t need to be in the hospital,” he explains. “But the hospital is certainly a big part of that health system.”

In fact, physicians who play to the strengths of the new healthcare metrics—quality, value, lower-cost care—can probably earn as much compensation as, if not more than, they could in the traditional fee-for-service model hospitalists, Guterman says.

“The big point is to remind people that when we’re talking about controlling health spending growth, we’re still talking about a growing industry,” he notes. “We’re not talking about disenfranchising healthcare or providers. We’re talking about more reasonable growth and about, more than anything, paying for the right things. Folks ought to be able to do quite well if they do the right things.”

click for large version

Multiple Uses

The SOHM report can be used as a measuring stick to compare against national and regional competitors and to provide data points for discussions with hospital administrators, says Team Hospitalist’s Weiss.

“This is vital in terms of recruiting physicians,” he says, “as well as negotiating with the hospital, as far as what the average investment is.”

Dr. Landis of SHM’s Practice Analysis Committee believes that having data points to make “resourcing decisions” with is particularly helpful, both in hiring and scheduling and in “right-sizing” hospital support for groups that are not self-sufficient.

“It is critical for physicians and their administrative partners to get the resourcing right, as inappropriately resourced groups [too much or too little] can quickly become unsustainable and/or unstable,” Dr. Landis says.

Take his group’s compensation.

“When we look at what we want to incent physicians, we’ll look at what other groups are doing,” Dr. Landis adds. “Are they using core measures? Are they using patient satisfaction? What about good citizenship? It’s one thing to say, ‘A hospital down the road is doing it.’ It’s another thing to take this book and say, ‘Let’s look the numbers up.’”

Of course, the wrinkle in benchmarking against national or regional figures is that HMGs can be “very particular,” says MGMA’s Robinson.

“We use benchmarks to give us an idea of what the pulse is, but we don’t use it as the only number,” she adds. “It’s very individualistic to the practice and to the program.”

Dr. Landis understands that point of view. Take his group’s policy on how much of hospitalists’ compensation is based on performance. The median component of compensation tied to performance for hospitalists nationwide is 6.6%, according to SOHM 2014. Dr. Landis’ group is at 15%. In meetings with his C-suite executives, he says he thinks in the back of his mind about how far outside the mean his group is in that regard. But he tempers that thought with the view that many hospitalists believe that performance and other metrics will continue to grow into a larger portion of hospitalists’ overall compensation.

“You have to be careful,” he says. “The first person to do an innovative, valuable thing isn’t going to be the 85%. You have to be careful not to stifle innovation. One of the cautions is not to use ‘just because everyone else is doing it means it’s the best way.’”

Weiss calls on an old adage in the industry: “If you’ve seen one hospitalist program, you’ve seen exactly one hospitalist program,” he says. “Because while they can be part of a large health system or a management company, while they try to have some commonality or some typical procedures, there’s still going to be individuality.”

Richard Quinn is a freelance writer in New Jersey.

The highlight of SHM’s biennial State of Hospital Medicine (SOHM) report is how much hospitalists earn. So it’s to be expected that rank-and-file practitioners and group leaders who read this year’s edition will first notice that median compensation for adult hospitalists rose 8% to $252,996 in 2013, according to data from the Medical Group Management Association (MGMA). The compensation data from MGMA is wrapped into the SOHM 2014 report this year.

But to stop there would be a wasted opportunity, says William “Tex” Landis, MD, FHM, medical director of Wellspan Hospitalists in York, Pa., and a member and former chair of SHM’s Practice Analysis Committee. Along with compensation, the report (available at www.hospitalmedicine.org/survey) delves into scheduling, productivity, staffing, how compensation is broken down, practice models, and dozens of other topics that hospital medicine group (HMG) leaders will find useful.

“Scope of services is a big one,” Dr. Landis adds. “What other things are hospital medicine groups around the country being held responsible for? Are we morphing into universal admitters? How involved in palliative care are we? What about transitions of care? How many hospital medicine groups are becoming involved in managing nursing home patients? What’s the relationship with surgical co-management? How much ICU work are we doing?”

Dr. Landis’ laundry list of unanswered questions might seem daunting, but that’s the point of the research SHM has been collecting and reporting for years. The society surveyed 499 groups, representing some 6,300 providers, to give the specialty’s most detailed list of most popular, if not best, practices.

“It has the usual limitations of any survey; however, it is the very best survey, quantity and quality, of hospital medicine groups,” Dr. Landis says. “And so it becomes the best source of information to make important decisions about resourcing and operating hospital medicine groups.”

Earnings Up

And, like it or not, compensation for providers typically is a HMG’s largest budget line. In that regard, the specialty appears to be doing well. Median compensation for adult hospitalists rose to a record high last year, according to the MGMA Physician Compensation and Production Survey: 2014 Report Based on 2013 Data. Half of respondents work in practices owned by hospitals/integrated delivery systems, down from 56% in SOHM 2012.

Although hospitalists in the South region continue to earn the most (median compensation $258,020, essentially static with the $258,793 figure reported in 2012), the region was the only one to report a decrease (see Table 1 for historical data). The largest percentage jump (11.8%) was for hospitalists in the West region ($249,894). Hospitalists in the Midwest saw a 10% increase ($261,868), while those in the East had both the smallest increase (4.8%) and the lowest median compensation ($238,676).

It will be interesting to see what the data shows over the next three or four years if stipends, as we believe we are seeing, come under pressure and hospitals are doing more outsourcing.

—R. Jeffrey Taylor, president and COO, IPC The Hospitalist Co., North Hollywood, Calif.

Part of the compensation increase is tied to upward pressure on productivity. Nationwide, median relative value units (RVUs) rose 3.3%, to 4,297 from 4,159. Median collection-to-work RVUs ticked up 6.8%, to 51.5 from 48.21 (see Table 2 for regional breakdowns). Production (10.5%) and performance (6.6%) are also slightly larger portions of mean compensation than they were in 2012, a figure many expect to increase further in future reports. The report also noted that academic/university hospitalists receive more in base pay, while hospitalists in private practice receive less.

Compensation and work volume will be intrinsically tied in the coming years, says R. Jeffrey Taylor, president and chief operating officer of IPC The Hospitalist Co., based in North Hollywood, Calif. And if pay outpaces productivity, “then it’s a bit concerning for the system at large,” he says.

“Particularly for whoever is subsidizing that shortfall, whether it’s a hospital employing doctors or an outsourced group employing the doctors but requiring a large subsidy from the hospital because the doctors are not seeing enough patient flow to pay their salary and benefits,” Taylor says.

More than 89% of HMGs rely on their host hospitals for financial support, according to the new data. The median support is $156,063 per full-time employee (FTE), which would total $1 million at just over seven FTEs. As healthcare reform progresses and hospitals’ budgets are increasingly burdened, Taylor says that pressure for hospitalists to generate enough revenue to cover their own salaries will grow. That sets up a likely showdown between hospitalists and their institutions; SOHM 2014 reported that just 6% of HMGs received enough income from professional fee revenue to cover expenses.

click for large version

click for large version

“Some productivity element in compensation plans, we believe, and I believe personally, is important,” Taylor says, later adding: “We already have a physician shortage and a shortage of people to see all these patients. It’s exacerbated by two things: lack of productivity and shift-model scheduling.”

To wit, IPC pays lower base salaries but provides bonuses tied to productivity and quality metrics. The average IPC hospitalist, Taylor says, earned more than $290,000 last year, nearly 15% above the median figure in the SOHM report. Between 30%-40% of that compensation, however, was earned via bonus tied to both “productivity and clinical achievement.”

Taylor, an outspoken advocate for moving away from the seven-on/seven-off scheduling model popular throughout hospital medicine, ties some of his doctors’ higher compensation to his firm’s preference for avoiding that schedule. But he’s not surprised the new report shows that 53.8% of responding HMGs use the model, up from 41.9% in 2012.

“It will be interesting to see what the data shows over the next three or four years,” he says, “if stipends, as we believe we are seeing, come under pressure and hospitals are doing more outsourcing.”

click for large version

The PCP Link

Industry leaders use the information in the biennial reports to gauge where the specialty stands in the overall healthcare spectrum. Dea Robinson, MA, FACMPE, CPC, director of consulting for MGMA Health Care Consulting Group, says that the growth of hospital medicine (HM) compensation is tied to that of primary care physicians (PCPs).

“I don’t think we can look at hospitalists without looking at primary care, because it’s really an extension of primary care,” says Robinson, a member of SHM’s Practice Management Committee. “As primary care compensation increases, hospitalists’ compensation might increase as well. And with the focus on patient-centered medical homes, which is basically primary care centered, that might very well be part of the driver in the future of seeing hospitalists grow.”

While facing a well-known physician shortage, primary care’s compensation growth also lags behind HM. For example, median compensation for hospitalists rose 8%; it increased 5.5% for PCPs.

“When it comes to growth of the two individual industries, I think they are connected in some way,” she adds. “But in terms of the compensation, now we’re starting to see different codes that hospitalists are able to use but that primary care used to use exclusively. So, you really see more of an extension and a collaboration between true primary care and hospitalists.”

Bryan Weiss, MBA, FHM, managing director of the consulting services practice at Irving, Texas-based MedSynergies, agrees that hospitalists and PCPs are connected. He believes the higher compensation figures are a sign of how young HM is as a specialty. He fears compensation “is probably growing too fast.”

“This takes me back to the 1990s, with the private [physician practice management]-type model, where it just grew so fast that the bottom fell out,” says Weiss, a member of Team Hospitalist. “Not that I think the bottom is going to fall out of hospital medicine, but a lot of this is reminiscent of that, and I think there’s going to be a ceiling, or at least a slowing down.”

We’re not talking about disenfranchising healthcare or providers. We’re talking about more reasonable growth and about, more than anything, paying for the right things.

—Stuart Guterman, vice president, Medicare and cost control, The Commonwealth Fund

In contrast, one good sign for the specialty’s compensation and financial support is that “hospitals are still the hub of the healthcare system and need to be an important part of healthcare reform,” says Stuart Guterman, vice president for Medicare and cost control at The Commonwealth Fund, a New York foundation focused on improving healthcare delivery. Guterman says that while President Obama and congressional leaders are looking to cut the rate of growth in healthcare spending, the figure is already so high that there should still be plenty of resources in the system.

“If you took today’s spending and you increased it at the [GDP] growth rate for 10 years, I think we’re talking about something over $30 trillion over 10 years,” Guterman says. “And remember that we’re starting at a point that’s over 50% higher than any other country in the world. So, we’re talking about plenty of resources still in this healthcare system.”

With accountable care organizations, the specter of bundled payments, and penalties for readmitted patients, Guterman says that the pending issue for the specialty isn’t whether hospitalists—or other hospital-based practitioners—are going to get paid more or less, but rather what their compensation will be based on.

“Things like better coordination of care, sending the patients to the right place, having the patients in the right place, having them in the hospital if they need to be, or keeping them out of the hospital if they don’t need to be in the hospital,” he explains. “But the hospital is certainly a big part of that health system.”

In fact, physicians who play to the strengths of the new healthcare metrics—quality, value, lower-cost care—can probably earn as much compensation as, if not more than, they could in the traditional fee-for-service model hospitalists, Guterman says.

“The big point is to remind people that when we’re talking about controlling health spending growth, we’re still talking about a growing industry,” he notes. “We’re not talking about disenfranchising healthcare or providers. We’re talking about more reasonable growth and about, more than anything, paying for the right things. Folks ought to be able to do quite well if they do the right things.”

click for large version

Multiple Uses

The SOHM report can be used as a measuring stick to compare against national and regional competitors and to provide data points for discussions with hospital administrators, says Team Hospitalist’s Weiss.

“This is vital in terms of recruiting physicians,” he says, “as well as negotiating with the hospital, as far as what the average investment is.”

Dr. Landis of SHM’s Practice Analysis Committee believes that having data points to make “resourcing decisions” with is particularly helpful, both in hiring and scheduling and in “right-sizing” hospital support for groups that are not self-sufficient.

“It is critical for physicians and their administrative partners to get the resourcing right, as inappropriately resourced groups [too much or too little] can quickly become unsustainable and/or unstable,” Dr. Landis says.

Take his group’s compensation.

“When we look at what we want to incent physicians, we’ll look at what other groups are doing,” Dr. Landis adds. “Are they using core measures? Are they using patient satisfaction? What about good citizenship? It’s one thing to say, ‘A hospital down the road is doing it.’ It’s another thing to take this book and say, ‘Let’s look the numbers up.’”

Of course, the wrinkle in benchmarking against national or regional figures is that HMGs can be “very particular,” says MGMA’s Robinson.

“We use benchmarks to give us an idea of what the pulse is, but we don’t use it as the only number,” she adds. “It’s very individualistic to the practice and to the program.”

Dr. Landis understands that point of view. Take his group’s policy on how much of hospitalists’ compensation is based on performance. The median component of compensation tied to performance for hospitalists nationwide is 6.6%, according to SOHM 2014. Dr. Landis’ group is at 15%. In meetings with his C-suite executives, he says he thinks in the back of his mind about how far outside the mean his group is in that regard. But he tempers that thought with the view that many hospitalists believe that performance and other metrics will continue to grow into a larger portion of hospitalists’ overall compensation.

“You have to be careful,” he says. “The first person to do an innovative, valuable thing isn’t going to be the 85%. You have to be careful not to stifle innovation. One of the cautions is not to use ‘just because everyone else is doing it means it’s the best way.’”

Weiss calls on an old adage in the industry: “If you’ve seen one hospitalist program, you’ve seen exactly one hospitalist program,” he says. “Because while they can be part of a large health system or a management company, while they try to have some commonality or some typical procedures, there’s still going to be individuality.”

Richard Quinn is a freelance writer in New Jersey.

The highlight of SHM’s biennial State of Hospital Medicine (SOHM) report is how much hospitalists earn. So it’s to be expected that rank-and-file practitioners and group leaders who read this year’s edition will first notice that median compensation for adult hospitalists rose 8% to $252,996 in 2013, according to data from the Medical Group Management Association (MGMA). The compensation data from MGMA is wrapped into the SOHM 2014 report this year.

But to stop there would be a wasted opportunity, says William “Tex” Landis, MD, FHM, medical director of Wellspan Hospitalists in York, Pa., and a member and former chair of SHM’s Practice Analysis Committee. Along with compensation, the report (available at www.hospitalmedicine.org/survey) delves into scheduling, productivity, staffing, how compensation is broken down, practice models, and dozens of other topics that hospital medicine group (HMG) leaders will find useful.

“Scope of services is a big one,” Dr. Landis adds. “What other things are hospital medicine groups around the country being held responsible for? Are we morphing into universal admitters? How involved in palliative care are we? What about transitions of care? How many hospital medicine groups are becoming involved in managing nursing home patients? What’s the relationship with surgical co-management? How much ICU work are we doing?”

Dr. Landis’ laundry list of unanswered questions might seem daunting, but that’s the point of the research SHM has been collecting and reporting for years. The society surveyed 499 groups, representing some 6,300 providers, to give the specialty’s most detailed list of most popular, if not best, practices.

“It has the usual limitations of any survey; however, it is the very best survey, quantity and quality, of hospital medicine groups,” Dr. Landis says. “And so it becomes the best source of information to make important decisions about resourcing and operating hospital medicine groups.”

Earnings Up

And, like it or not, compensation for providers typically is a HMG’s largest budget line. In that regard, the specialty appears to be doing well. Median compensation for adult hospitalists rose to a record high last year, according to the MGMA Physician Compensation and Production Survey: 2014 Report Based on 2013 Data. Half of respondents work in practices owned by hospitals/integrated delivery systems, down from 56% in SOHM 2012.

Although hospitalists in the South region continue to earn the most (median compensation $258,020, essentially static with the $258,793 figure reported in 2012), the region was the only one to report a decrease (see Table 1 for historical data). The largest percentage jump (11.8%) was for hospitalists in the West region ($249,894). Hospitalists in the Midwest saw a 10% increase ($261,868), while those in the East had both the smallest increase (4.8%) and the lowest median compensation ($238,676).

It will be interesting to see what the data shows over the next three or four years if stipends, as we believe we are seeing, come under pressure and hospitals are doing more outsourcing.

—R. Jeffrey Taylor, president and COO, IPC The Hospitalist Co., North Hollywood, Calif.

Part of the compensation increase is tied to upward pressure on productivity. Nationwide, median relative value units (RVUs) rose 3.3%, to 4,297 from 4,159. Median collection-to-work RVUs ticked up 6.8%, to 51.5 from 48.21 (see Table 2 for regional breakdowns). Production (10.5%) and performance (6.6%) are also slightly larger portions of mean compensation than they were in 2012, a figure many expect to increase further in future reports. The report also noted that academic/university hospitalists receive more in base pay, while hospitalists in private practice receive less.

Compensation and work volume will be intrinsically tied in the coming years, says R. Jeffrey Taylor, president and chief operating officer of IPC The Hospitalist Co., based in North Hollywood, Calif. And if pay outpaces productivity, “then it’s a bit concerning for the system at large,” he says.

“Particularly for whoever is subsidizing that shortfall, whether it’s a hospital employing doctors or an outsourced group employing the doctors but requiring a large subsidy from the hospital because the doctors are not seeing enough patient flow to pay their salary and benefits,” Taylor says.

More than 89% of HMGs rely on their host hospitals for financial support, according to the new data. The median support is $156,063 per full-time employee (FTE), which would total $1 million at just over seven FTEs. As healthcare reform progresses and hospitals’ budgets are increasingly burdened, Taylor says that pressure for hospitalists to generate enough revenue to cover their own salaries will grow. That sets up a likely showdown between hospitalists and their institutions; SOHM 2014 reported that just 6% of HMGs received enough income from professional fee revenue to cover expenses.

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“Some productivity element in compensation plans, we believe, and I believe personally, is important,” Taylor says, later adding: “We already have a physician shortage and a shortage of people to see all these patients. It’s exacerbated by two things: lack of productivity and shift-model scheduling.”

To wit, IPC pays lower base salaries but provides bonuses tied to productivity and quality metrics. The average IPC hospitalist, Taylor says, earned more than $290,000 last year, nearly 15% above the median figure in the SOHM report. Between 30%-40% of that compensation, however, was earned via bonus tied to both “productivity and clinical achievement.”

Taylor, an outspoken advocate for moving away from the seven-on/seven-off scheduling model popular throughout hospital medicine, ties some of his doctors’ higher compensation to his firm’s preference for avoiding that schedule. But he’s not surprised the new report shows that 53.8% of responding HMGs use the model, up from 41.9% in 2012.

“It will be interesting to see what the data shows over the next three or four years,” he says, “if stipends, as we believe we are seeing, come under pressure and hospitals are doing more outsourcing.”

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The PCP Link

Industry leaders use the information in the biennial reports to gauge where the specialty stands in the overall healthcare spectrum. Dea Robinson, MA, FACMPE, CPC, director of consulting for MGMA Health Care Consulting Group, says that the growth of hospital medicine (HM) compensation is tied to that of primary care physicians (PCPs).

“I don’t think we can look at hospitalists without looking at primary care, because it’s really an extension of primary care,” says Robinson, a member of SHM’s Practice Management Committee. “As primary care compensation increases, hospitalists’ compensation might increase as well. And with the focus on patient-centered medical homes, which is basically primary care centered, that might very well be part of the driver in the future of seeing hospitalists grow.”

While facing a well-known physician shortage, primary care’s compensation growth also lags behind HM. For example, median compensation for hospitalists rose 8%; it increased 5.5% for PCPs.

“When it comes to growth of the two individual industries, I think they are connected in some way,” she adds. “But in terms of the compensation, now we’re starting to see different codes that hospitalists are able to use but that primary care used to use exclusively. So, you really see more of an extension and a collaboration between true primary care and hospitalists.”

Bryan Weiss, MBA, FHM, managing director of the consulting services practice at Irving, Texas-based MedSynergies, agrees that hospitalists and PCPs are connected. He believes the higher compensation figures are a sign of how young HM is as a specialty. He fears compensation “is probably growing too fast.”

“This takes me back to the 1990s, with the private [physician practice management]-type model, where it just grew so fast that the bottom fell out,” says Weiss, a member of Team Hospitalist. “Not that I think the bottom is going to fall out of hospital medicine, but a lot of this is reminiscent of that, and I think there’s going to be a ceiling, or at least a slowing down.”

We’re not talking about disenfranchising healthcare or providers. We’re talking about more reasonable growth and about, more than anything, paying for the right things.

—Stuart Guterman, vice president, Medicare and cost control, The Commonwealth Fund

In contrast, one good sign for the specialty’s compensation and financial support is that “hospitals are still the hub of the healthcare system and need to be an important part of healthcare reform,” says Stuart Guterman, vice president for Medicare and cost control at The Commonwealth Fund, a New York foundation focused on improving healthcare delivery. Guterman says that while President Obama and congressional leaders are looking to cut the rate of growth in healthcare spending, the figure is already so high that there should still be plenty of resources in the system.

“If you took today’s spending and you increased it at the [GDP] growth rate for 10 years, I think we’re talking about something over $30 trillion over 10 years,” Guterman says. “And remember that we’re starting at a point that’s over 50% higher than any other country in the world. So, we’re talking about plenty of resources still in this healthcare system.”

With accountable care organizations, the specter of bundled payments, and penalties for readmitted patients, Guterman says that the pending issue for the specialty isn’t whether hospitalists—or other hospital-based practitioners—are going to get paid more or less, but rather what their compensation will be based on.

“Things like better coordination of care, sending the patients to the right place, having the patients in the right place, having them in the hospital if they need to be, or keeping them out of the hospital if they don’t need to be in the hospital,” he explains. “But the hospital is certainly a big part of that health system.”

In fact, physicians who play to the strengths of the new healthcare metrics—quality, value, lower-cost care—can probably earn as much compensation as, if not more than, they could in the traditional fee-for-service model hospitalists, Guterman says.

“The big point is to remind people that when we’re talking about controlling health spending growth, we’re still talking about a growing industry,” he notes. “We’re not talking about disenfranchising healthcare or providers. We’re talking about more reasonable growth and about, more than anything, paying for the right things. Folks ought to be able to do quite well if they do the right things.”

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Multiple Uses

The SOHM report can be used as a measuring stick to compare against national and regional competitors and to provide data points for discussions with hospital administrators, says Team Hospitalist’s Weiss.

“This is vital in terms of recruiting physicians,” he says, “as well as negotiating with the hospital, as far as what the average investment is.”

Dr. Landis of SHM’s Practice Analysis Committee believes that having data points to make “resourcing decisions” with is particularly helpful, both in hiring and scheduling and in “right-sizing” hospital support for groups that are not self-sufficient.

“It is critical for physicians and their administrative partners to get the resourcing right, as inappropriately resourced groups [too much or too little] can quickly become unsustainable and/or unstable,” Dr. Landis says.

Take his group’s compensation.

“When we look at what we want to incent physicians, we’ll look at what other groups are doing,” Dr. Landis adds. “Are they using core measures? Are they using patient satisfaction? What about good citizenship? It’s one thing to say, ‘A hospital down the road is doing it.’ It’s another thing to take this book and say, ‘Let’s look the numbers up.’”

Of course, the wrinkle in benchmarking against national or regional figures is that HMGs can be “very particular,” says MGMA’s Robinson.

“We use benchmarks to give us an idea of what the pulse is, but we don’t use it as the only number,” she adds. “It’s very individualistic to the practice and to the program.”

Dr. Landis understands that point of view. Take his group’s policy on how much of hospitalists’ compensation is based on performance. The median component of compensation tied to performance for hospitalists nationwide is 6.6%, according to SOHM 2014. Dr. Landis’ group is at 15%. In meetings with his C-suite executives, he says he thinks in the back of his mind about how far outside the mean his group is in that regard. But he tempers that thought with the view that many hospitalists believe that performance and other metrics will continue to grow into a larger portion of hospitalists’ overall compensation.

“You have to be careful,” he says. “The first person to do an innovative, valuable thing isn’t going to be the 85%. You have to be careful not to stifle innovation. One of the cautions is not to use ‘just because everyone else is doing it means it’s the best way.’”

Weiss calls on an old adage in the industry: “If you’ve seen one hospitalist program, you’ve seen exactly one hospitalist program,” he says. “Because while they can be part of a large health system or a management company, while they try to have some commonality or some typical procedures, there’s still going to be individuality.”

Richard Quinn is a freelance writer in New Jersey.

Red blood cells coagulate

to form a blood clot

Credit: James Weaver

Researchers have developed a coating that can prevent blood and bacteria from adhering to the surface of medical devices.

The coating repelled blood from more than 20 medically relevant substrates, suppressed biofilm formation, and prevented coagulation in an animal model for at least 8 hours.

The researchers believe this technology could reduce the use of anticoagulants and help prevent thrombotic occlusion and biofouling of medical devices.

The idea for the coating evolved from a surface technology known as “slippery liquid-infused porous surfaces (SLIPS),” which was developed by Joanna Aizenberg, PhD, of Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Inspired by the slippery surface of the carnivorous pitcher plant, which enables the plant to capture insects, SLIPS can repel nearly any material. The liquid layer on the surface provides a barrier to everything from ice to crude oil and blood.

“Traditional SLIPS uses porous, textured surface substrates to immobilize the liquid layer, whereas medical surfaces are mostly flat and smooth,” Dr Aizenberg said. “So we further adapted our approach by capitalizing on the natural roughness of chemically modified surfaces of medical devices.”

She and her colleagues described this work in Nature Biotechnology.

The researchers developed a super-repellent coating that can be adhered to existing, approved medical devices. In a 2-step surface-coating process, they chemically attached a monolayer of perfluorocarbon, which is similar to Teflon.

Then, they added a layer of liquid perfluorocarbon, which is widely used in medicine for applications such as liquid ventilation for infants with breathing challenges, blood substitution, and eye surgery. The team calls the tethered perfluorocarbon plus the liquid layer a “tethered-liquid perfluorocarbon surface (TLP)”.

TLP worked seamlessly when coated on more than 20 different medical surfaces, including plastics, glasses, and metals.

The researchers also implanted medical-grade tubing and catheters coated with TLP in large blood vessels in pigs, and the coating prevented blood from clotting for at least 8 hours without the use of anticoagulants.

TLP-treated medical tubing was stored for more than a year under normal temperature and humidity conditions and still prevented clot formation, repelling fibrin and platelets.

The TLP surface remained stable under the full range of clinically relevant physiological shear stresses, or rates of blood flow seen in catheters and central lines, all the way up to dialysis machines.

When the bacteria Pseudomonas aeruginosa were grown in TLP-coated medical tubing for more than 6 weeks, less than 1 in a billion bacteria were able to adhere. Central lines coated with TLP significantly reduced sepsis from central-line associated bloodstream infections.

Out of curiosity, the researchers even tested a TLP-coated surface with a gecko, whose footpads contain hair-like structures with tremendous adhesive strength. And the gecko was unable to hold on.

“We were wonderfully surprised by how well the TLP coating worked, particularly in vivo without heparin,” said Anna Waterhouse, PhD, of the Wyss Institute.

“Usually, the blood will start to clot within an hour in the extracorporeal circuit, so our experiments really demonstrate the clinical relevance of this new coating.”

Red blood cells coagulate

to form a blood clot

Credit: James Weaver

Researchers have developed a coating that can prevent blood and bacteria from adhering to the surface of medical devices.

The coating repelled blood from more than 20 medically relevant substrates, suppressed biofilm formation, and prevented coagulation in an animal model for at least 8 hours.

The researchers believe this technology could reduce the use of anticoagulants and help prevent thrombotic occlusion and biofouling of medical devices.

The idea for the coating evolved from a surface technology known as “slippery liquid-infused porous surfaces (SLIPS),” which was developed by Joanna Aizenberg, PhD, of Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Inspired by the slippery surface of the carnivorous pitcher plant, which enables the plant to capture insects, SLIPS can repel nearly any material. The liquid layer on the surface provides a barrier to everything from ice to crude oil and blood.

“Traditional SLIPS uses porous, textured surface substrates to immobilize the liquid layer, whereas medical surfaces are mostly flat and smooth,” Dr Aizenberg said. “So we further adapted our approach by capitalizing on the natural roughness of chemically modified surfaces of medical devices.”

She and her colleagues described this work in Nature Biotechnology.

The researchers developed a super-repellent coating that can be adhered to existing, approved medical devices. In a 2-step surface-coating process, they chemically attached a monolayer of perfluorocarbon, which is similar to Teflon.

Then, they added a layer of liquid perfluorocarbon, which is widely used in medicine for applications such as liquid ventilation for infants with breathing challenges, blood substitution, and eye surgery. The team calls the tethered perfluorocarbon plus the liquid layer a “tethered-liquid perfluorocarbon surface (TLP)”.

TLP worked seamlessly when coated on more than 20 different medical surfaces, including plastics, glasses, and metals.

The researchers also implanted medical-grade tubing and catheters coated with TLP in large blood vessels in pigs, and the coating prevented blood from clotting for at least 8 hours without the use of anticoagulants.

TLP-treated medical tubing was stored for more than a year under normal temperature and humidity conditions and still prevented clot formation, repelling fibrin and platelets.

The TLP surface remained stable under the full range of clinically relevant physiological shear stresses, or rates of blood flow seen in catheters and central lines, all the way up to dialysis machines.

When the bacteria Pseudomonas aeruginosa were grown in TLP-coated medical tubing for more than 6 weeks, less than 1 in a billion bacteria were able to adhere. Central lines coated with TLP significantly reduced sepsis from central-line associated bloodstream infections.

Out of curiosity, the researchers even tested a TLP-coated surface with a gecko, whose footpads contain hair-like structures with tremendous adhesive strength. And the gecko was unable to hold on.

“We were wonderfully surprised by how well the TLP coating worked, particularly in vivo without heparin,” said Anna Waterhouse, PhD, of the Wyss Institute.

“Usually, the blood will start to clot within an hour in the extracorporeal circuit, so our experiments really demonstrate the clinical relevance of this new coating.”

Red blood cells coagulate

to form a blood clot

Credit: James Weaver

Researchers have developed a coating that can prevent blood and bacteria from adhering to the surface of medical devices.

The coating repelled blood from more than 20 medically relevant substrates, suppressed biofilm formation, and prevented coagulation in an animal model for at least 8 hours.

The researchers believe this technology could reduce the use of anticoagulants and help prevent thrombotic occlusion and biofouling of medical devices.

The idea for the coating evolved from a surface technology known as “slippery liquid-infused porous surfaces (SLIPS),” which was developed by Joanna Aizenberg, PhD, of Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Inspired by the slippery surface of the carnivorous pitcher plant, which enables the plant to capture insects, SLIPS can repel nearly any material. The liquid layer on the surface provides a barrier to everything from ice to crude oil and blood.

“Traditional SLIPS uses porous, textured surface substrates to immobilize the liquid layer, whereas medical surfaces are mostly flat and smooth,” Dr Aizenberg said. “So we further adapted our approach by capitalizing on the natural roughness of chemically modified surfaces of medical devices.”

She and her colleagues described this work in Nature Biotechnology.

The researchers developed a super-repellent coating that can be adhered to existing, approved medical devices. In a 2-step surface-coating process, they chemically attached a monolayer of perfluorocarbon, which is similar to Teflon.

Then, they added a layer of liquid perfluorocarbon, which is widely used in medicine for applications such as liquid ventilation for infants with breathing challenges, blood substitution, and eye surgery. The team calls the tethered perfluorocarbon plus the liquid layer a “tethered-liquid perfluorocarbon surface (TLP)”.

TLP worked seamlessly when coated on more than 20 different medical surfaces, including plastics, glasses, and metals.

The researchers also implanted medical-grade tubing and catheters coated with TLP in large blood vessels in pigs, and the coating prevented blood from clotting for at least 8 hours without the use of anticoagulants.

TLP-treated medical tubing was stored for more than a year under normal temperature and humidity conditions and still prevented clot formation, repelling fibrin and platelets.

The TLP surface remained stable under the full range of clinically relevant physiological shear stresses, or rates of blood flow seen in catheters and central lines, all the way up to dialysis machines.

When the bacteria Pseudomonas aeruginosa were grown in TLP-coated medical tubing for more than 6 weeks, less than 1 in a billion bacteria were able to adhere. Central lines coated with TLP significantly reduced sepsis from central-line associated bloodstream infections.

Out of curiosity, the researchers even tested a TLP-coated surface with a gecko, whose footpads contain hair-like structures with tremendous adhesive strength. And the gecko was unable to hold on.

“We were wonderfully surprised by how well the TLP coating worked, particularly in vivo without heparin,” said Anna Waterhouse, PhD, of the Wyss Institute.

“Usually, the blood will start to clot within an hour in the extracorporeal circuit, so our experiments really demonstrate the clinical relevance of this new coating.”

Doctor and patient

Credit: CDC

An early warning and response system can predict a patient’s likelihood of developing sepsis, according to research published in the Journal of Hospital Medicine.

The system uses lab and vital-sign data in the electronic health record of hospital inpatients to identify those at risk for sepsis.

In a multi-hospital study, the system allowed for a marked increase in sepsis identification and care, transfer to the intensive care unit (ICU), and an indication of fewer deaths due to sepsis.

Craig A. Umscheid, MD, of Penn Medicine in Philadelphia, and his colleagues developed the system using 4575 patients admitted to the University of Pennsylvania Health System in October 2011.

The system monitored lab values and vital signs in real time. If a patient had 4 or more predefined abnormalities at any single time, an electronic communication was sent to the provider, nurse, and rapid response coordinator, who performed an immediate bedside patient evaluation.

The researchers validated the effectiveness of the system during a pre-implementation period from June to September 2012, when data on admitted patients was evaluated and alerts triggered in a database, but no notifications were sent to providers on the ground.

Outcomes in that control period were then compared to a post-implementation period from June to September 2013. The total number of patients included in both periods was 31,093.

In the pre- and post-implementation periods, 4% of patient visits triggered the alert. Analysis revealed that 90% of those patients received bedside evaluations by the care team within 30 minutes of the alert being issued.

The system resulted in a 2- to 3-fold increase in orders for tests that could help identify the presence of sepsis and a 1.5- to 2-fold increase in the administration of antibiotics and intravenous fluids.

The system prompted an increase of more than 50% in the proportion of patients quickly transferred to the ICU and a 50% increase in documentation of sepsis in the patients’ electronic health record.

There was a lower death rate from sepsis and an increase in the number of patients successfully discharged home in the post-implementation period. But these rates were not significantly different from those in the pre-implementation period.

“Our study is the first we’re aware of that was implemented throughout a multihospital health system,” Dr Umscheid said.

“Previous studies that have examined the impact of sepsis prediction tools at other institutions have only taken place on a limited number of inpatient wards. The varied patient populations, clinical staffing, practice models, and practice cultures across our health system increases the generalizability of our findings to other healthcare settings.”

Dr Umscheid also noted that the system could help triage patients for suitability of ICU transfer.

“By better identifying those with sepsis requiring advanced care,” he said, “the tool can help screen out patients not needing the inevitably limited number of ICU beds.”

Doctor and patient

Credit: CDC

An early warning and response system can predict a patient’s likelihood of developing sepsis, according to research published in the Journal of Hospital Medicine.

The system uses lab and vital-sign data in the electronic health record of hospital inpatients to identify those at risk for sepsis.

In a multi-hospital study, the system allowed for a marked increase in sepsis identification and care, transfer to the intensive care unit (ICU), and an indication of fewer deaths due to sepsis.

Craig A. Umscheid, MD, of Penn Medicine in Philadelphia, and his colleagues developed the system using 4575 patients admitted to the University of Pennsylvania Health System in October 2011.

The system monitored lab values and vital signs in real time. If a patient had 4 or more predefined abnormalities at any single time, an electronic communication was sent to the provider, nurse, and rapid response coordinator, who performed an immediate bedside patient evaluation.

The researchers validated the effectiveness of the system during a pre-implementation period from June to September 2012, when data on admitted patients was evaluated and alerts triggered in a database, but no notifications were sent to providers on the ground.

Outcomes in that control period were then compared to a post-implementation period from June to September 2013. The total number of patients included in both periods was 31,093.

In the pre- and post-implementation periods, 4% of patient visits triggered the alert. Analysis revealed that 90% of those patients received bedside evaluations by the care team within 30 minutes of the alert being issued.

The system resulted in a 2- to 3-fold increase in orders for tests that could help identify the presence of sepsis and a 1.5- to 2-fold increase in the administration of antibiotics and intravenous fluids.

The system prompted an increase of more than 50% in the proportion of patients quickly transferred to the ICU and a 50% increase in documentation of sepsis in the patients’ electronic health record.

There was a lower death rate from sepsis and an increase in the number of patients successfully discharged home in the post-implementation period. But these rates were not significantly different from those in the pre-implementation period.

“Our study is the first we’re aware of that was implemented throughout a multihospital health system,” Dr Umscheid said.

“Previous studies that have examined the impact of sepsis prediction tools at other institutions have only taken place on a limited number of inpatient wards. The varied patient populations, clinical staffing, practice models, and practice cultures across our health system increases the generalizability of our findings to other healthcare settings.”

Dr Umscheid also noted that the system could help triage patients for suitability of ICU transfer.

“By better identifying those with sepsis requiring advanced care,” he said, “the tool can help screen out patients not needing the inevitably limited number of ICU beds.”

Doctor and patient

Credit: CDC

An early warning and response system can predict a patient’s likelihood of developing sepsis, according to research published in the Journal of Hospital Medicine.

The system uses lab and vital-sign data in the electronic health record of hospital inpatients to identify those at risk for sepsis.

In a multi-hospital study, the system allowed for a marked increase in sepsis identification and care, transfer to the intensive care unit (ICU), and an indication of fewer deaths due to sepsis.

Craig A. Umscheid, MD, of Penn Medicine in Philadelphia, and his colleagues developed the system using 4575 patients admitted to the University of Pennsylvania Health System in October 2011.

The system monitored lab values and vital signs in real time. If a patient had 4 or more predefined abnormalities at any single time, an electronic communication was sent to the provider, nurse, and rapid response coordinator, who performed an immediate bedside patient evaluation.

The researchers validated the effectiveness of the system during a pre-implementation period from June to September 2012, when data on admitted patients was evaluated and alerts triggered in a database, but no notifications were sent to providers on the ground.

Outcomes in that control period were then compared to a post-implementation period from June to September 2013. The total number of patients included in both periods was 31,093.

In the pre- and post-implementation periods, 4% of patient visits triggered the alert. Analysis revealed that 90% of those patients received bedside evaluations by the care team within 30 minutes of the alert being issued.

The system resulted in a 2- to 3-fold increase in orders for tests that could help identify the presence of sepsis and a 1.5- to 2-fold increase in the administration of antibiotics and intravenous fluids.

The system prompted an increase of more than 50% in the proportion of patients quickly transferred to the ICU and a 50% increase in documentation of sepsis in the patients’ electronic health record.

There was a lower death rate from sepsis and an increase in the number of patients successfully discharged home in the post-implementation period. But these rates were not significantly different from those in the pre-implementation period.

“Our study is the first we’re aware of that was implemented throughout a multihospital health system,” Dr Umscheid said.

“Previous studies that have examined the impact of sepsis prediction tools at other institutions have only taken place on a limited number of inpatient wards. The varied patient populations, clinical staffing, practice models, and practice cultures across our health system increases the generalizability of our findings to other healthcare settings.”

Dr Umscheid also noted that the system could help triage patients for suitability of ICU transfer.

“By better identifying those with sepsis requiring advanced care,” he said, “the tool can help screen out patients not needing the inevitably limited number of ICU beds.”

The US Food and Drug Administration (FDA) has approved Akynzeo to treat nausea and vomiting in cancer patients undergoing chemotherapy. Akynzeo is a capsule consisting of two drugs, netupitant and palonosetron.

Palonosetron prevents nausea and vomiting in the acute phase—within the first 24 hours of chemotherapy initiation.

Netupitant prevents nausea and vomiting in the acute phase and the delayed phase—25 to 120 hours after chemotherapy began.

Akynzeo’s effectiveness was established in two clinical trials of 1720 cancer patients receiving chemotherapy. Patients were randomized to receive Akynzeo or oral palonosetron.

The trials were designed to measure whether the drugs prevented any vomiting episodes in the acute, delayed, and overall phases after the start of chemotherapy.

Most Akynzeo-treated patients did not experience any vomiting or require rescue medication for nausea during the acute (98.5%), delayed (90.4%), and overall phases (89.6%).

The same was true for patients who received palonosetron, although percentages were lower—89.7%, 80.1%, and 76.5%, respectively.

The second trial showed similar results.

Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation.

Akynzeo is distributed and marketed by Eisai Inc., under license from Helsinn Healthcare S.A.

The US Food and Drug Administration (FDA) has approved Akynzeo to treat nausea and vomiting in cancer patients undergoing chemotherapy. Akynzeo is a capsule consisting of two drugs, netupitant and palonosetron.

Palonosetron prevents nausea and vomiting in the acute phase—within the first 24 hours of chemotherapy initiation.

Netupitant prevents nausea and vomiting in the acute phase and the delayed phase—25 to 120 hours after chemotherapy began.

Akynzeo’s effectiveness was established in two clinical trials of 1720 cancer patients receiving chemotherapy. Patients were randomized to receive Akynzeo or oral palonosetron.

The trials were designed to measure whether the drugs prevented any vomiting episodes in the acute, delayed, and overall phases after the start of chemotherapy.

Most Akynzeo-treated patients did not experience any vomiting or require rescue medication for nausea during the acute (98.5%), delayed (90.4%), and overall phases (89.6%).

The same was true for patients who received palonosetron, although percentages were lower—89.7%, 80.1%, and 76.5%, respectively.

The second trial showed similar results.

Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation.

Akynzeo is distributed and marketed by Eisai Inc., under license from Helsinn Healthcare S.A.

The US Food and Drug Administration (FDA) has approved Akynzeo to treat nausea and vomiting in cancer patients undergoing chemotherapy. Akynzeo is a capsule consisting of two drugs, netupitant and palonosetron.

Palonosetron prevents nausea and vomiting in the acute phase—within the first 24 hours of chemotherapy initiation.

Netupitant prevents nausea and vomiting in the acute phase and the delayed phase—25 to 120 hours after chemotherapy began.

Akynzeo’s effectiveness was established in two clinical trials of 1720 cancer patients receiving chemotherapy. Patients were randomized to receive Akynzeo or oral palonosetron.

The trials were designed to measure whether the drugs prevented any vomiting episodes in the acute, delayed, and overall phases after the start of chemotherapy.

Most Akynzeo-treated patients did not experience any vomiting or require rescue medication for nausea during the acute (98.5%), delayed (90.4%), and overall phases (89.6%).

The same was true for patients who received palonosetron, although percentages were lower—89.7%, 80.1%, and 76.5%, respectively.

The second trial showed similar results.

Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation.

Akynzeo is distributed and marketed by Eisai Inc., under license from Helsinn Healthcare S.A.

Keytruda

Merck & Co, Inc, announces US Food and Drug Administration approval of Keytruda (pembrolizumab) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600–mutation positive, a BRAF inhibitor. Keytruda is the first anti-PD-1 (programmed death receptor-1) therapy in the United States and is approved as a breakthrough therapy based on tumor response rate and durability of response. It works by increasing the ability of the body’s immune system to fight advanced melanoma. It blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2) and may affect both tumor cells and healthy cells. For more information, visit www.keytruda.com.

Otezla

Celgene Corporation obtains US Food and Drug Administration approval for Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is associated with an increase in adverse reactions of depression. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes. Otezla also is approved for patients with active psoriatic arthritis. For more information, visit www.otezla.com.

Papaya Enzyme Cleanser

Revision Skincare introduces the Papaya Enzyme Cleanser, an energizing facial wash formulated with a unique extract derived from papayas to nourish skin with a multitude of vitamins and minerals. The Papaya Enzyme Cleanser, available exclusively through physicians, helps patients achieve naturally vibrant skin. For more information, visit www.revisionskincare.com.

Pigmentclar

La Roche-Posay Laboratoire Dermatologique launches Pigmentclar Intensive Dark Spot Correcting Serum and Pigmentclar SPF 30 Daily Dark Spot Correcting Moisturizer to target multiple stages of dark spot development, leaving patients with a brighter, more even skin tone. The products are formulated to correct dark spots that are underlying, visible, or recurrent. Phe-resorcinol helps reduce excess melanin at the early stages of production, lipohydroxy acid enables cell-by-cell exfoliation, and niacinamide reduces melanin transfer from one cell to another. Both products can be purchased over-the-counter at select retailers, physicians’ offices, and online. For more information, visit www.laroche-posay.us.

Regenacyn

Oculus Innovative Sciences, Inc, introduces Regenacyn Advanced Scar Management Hydrogel to improve the texture, color, softness, and overall appearance of scars. Formulated with Microcyn technology, Regenacyn is intended for the management of old and new hypertrophic and keloid scars of various sizes, shapes, and locations resulting from burns, general surgical procedures, and trauma wounds. Regenacyn is physician dispensed by plastic surgeons and obstetricians/gynecologists. For more information, visit www.oculusis.com/regenacyn-hydrogel.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.

Keytruda

Merck & Co, Inc, announces US Food and Drug Administration approval of Keytruda (pembrolizumab) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600–mutation positive, a BRAF inhibitor. Keytruda is the first anti-PD-1 (programmed death receptor-1) therapy in the United States and is approved as a breakthrough therapy based on tumor response rate and durability of response. It works by increasing the ability of the body’s immune system to fight advanced melanoma. It blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2) and may affect both tumor cells and healthy cells. For more information, visit www.keytruda.com.

Otezla

Celgene Corporation obtains US Food and Drug Administration approval for Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is associated with an increase in adverse reactions of depression. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes. Otezla also is approved for patients with active psoriatic arthritis. For more information, visit www.otezla.com.

Papaya Enzyme Cleanser

Revision Skincare introduces the Papaya Enzyme Cleanser, an energizing facial wash formulated with a unique extract derived from papayas to nourish skin with a multitude of vitamins and minerals. The Papaya Enzyme Cleanser, available exclusively through physicians, helps patients achieve naturally vibrant skin. For more information, visit www.revisionskincare.com.

Pigmentclar

La Roche-Posay Laboratoire Dermatologique launches Pigmentclar Intensive Dark Spot Correcting Serum and Pigmentclar SPF 30 Daily Dark Spot Correcting Moisturizer to target multiple stages of dark spot development, leaving patients with a brighter, more even skin tone. The products are formulated to correct dark spots that are underlying, visible, or recurrent. Phe-resorcinol helps reduce excess melanin at the early stages of production, lipohydroxy acid enables cell-by-cell exfoliation, and niacinamide reduces melanin transfer from one cell to another. Both products can be purchased over-the-counter at select retailers, physicians’ offices, and online. For more information, visit www.laroche-posay.us.

Regenacyn

Oculus Innovative Sciences, Inc, introduces Regenacyn Advanced Scar Management Hydrogel to improve the texture, color, softness, and overall appearance of scars. Formulated with Microcyn technology, Regenacyn is intended for the management of old and new hypertrophic and keloid scars of various sizes, shapes, and locations resulting from burns, general surgical procedures, and trauma wounds. Regenacyn is physician dispensed by plastic surgeons and obstetricians/gynecologists. For more information, visit www.oculusis.com/regenacyn-hydrogel.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.

Keytruda

Merck & Co, Inc, announces US Food and Drug Administration approval of Keytruda (pembrolizumab) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600–mutation positive, a BRAF inhibitor. Keytruda is the first anti-PD-1 (programmed death receptor-1) therapy in the United States and is approved as a breakthrough therapy based on tumor response rate and durability of response. It works by increasing the ability of the body’s immune system to fight advanced melanoma. It blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2) and may affect both tumor cells and healthy cells. For more information, visit www.keytruda.com.

Otezla

Celgene Corporation obtains US Food and Drug Administration approval for Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is associated with an increase in adverse reactions of depression. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes. Otezla also is approved for patients with active psoriatic arthritis. For more information, visit www.otezla.com.

Papaya Enzyme Cleanser

Revision Skincare introduces the Papaya Enzyme Cleanser, an energizing facial wash formulated with a unique extract derived from papayas to nourish skin with a multitude of vitamins and minerals. The Papaya Enzyme Cleanser, available exclusively through physicians, helps patients achieve naturally vibrant skin. For more information, visit www.revisionskincare.com.

Pigmentclar

La Roche-Posay Laboratoire Dermatologique launches Pigmentclar Intensive Dark Spot Correcting Serum and Pigmentclar SPF 30 Daily Dark Spot Correcting Moisturizer to target multiple stages of dark spot development, leaving patients with a brighter, more even skin tone. The products are formulated to correct dark spots that are underlying, visible, or recurrent. Phe-resorcinol helps reduce excess melanin at the early stages of production, lipohydroxy acid enables cell-by-cell exfoliation, and niacinamide reduces melanin transfer from one cell to another. Both products can be purchased over-the-counter at select retailers, physicians’ offices, and online. For more information, visit www.laroche-posay.us.

Regenacyn

Oculus Innovative Sciences, Inc, introduces Regenacyn Advanced Scar Management Hydrogel to improve the texture, color, softness, and overall appearance of scars. Formulated with Microcyn technology, Regenacyn is intended for the management of old and new hypertrophic and keloid scars of various sizes, shapes, and locations resulting from burns, general surgical procedures, and trauma wounds. Regenacyn is physician dispensed by plastic surgeons and obstetricians/gynecologists. For more information, visit www.oculusis.com/regenacyn-hydrogel.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.

Due to a submission error, an acknowledgment was missing from the July 2014 article “The Great Mimickers of Rosacea” (Cutis. 2014;94:39-45).

Acknowledgements—The authors thank Jennifer Rullan, MD, San Diego, California, and Jose Gonzalez-Chavez, MD, San Juan, Puerto Rico, for their assistance.

Also, the order of the authors was incorrect in the July 2014 e-only article “Lepromatous Leprosy Associated With Erythema Nodosum Leprosum” (Cutis. 2014;94:E19-E20). The correct order is:

These articles have been corrected online.

Due to a submission error, an acknowledgment was missing from the July 2014 article “The Great Mimickers of Rosacea” (Cutis. 2014;94:39-45).

Acknowledgements—The authors thank Jennifer Rullan, MD, San Diego, California, and Jose Gonzalez-Chavez, MD, San Juan, Puerto Rico, for their assistance.

Also, the order of the authors was incorrect in the July 2014 e-only article “Lepromatous Leprosy Associated With Erythema Nodosum Leprosum” (Cutis. 2014;94:E19-E20). The correct order is:

These articles have been corrected online.

Due to a submission error, an acknowledgment was missing from the July 2014 article “The Great Mimickers of Rosacea” (Cutis. 2014;94:39-45).

Acknowledgements—The authors thank Jennifer Rullan, MD, San Diego, California, and Jose Gonzalez-Chavez, MD, San Juan, Puerto Rico, for their assistance.

Also, the order of the authors was incorrect in the July 2014 e-only article “Lepromatous Leprosy Associated With Erythema Nodosum Leprosum” (Cutis. 2014;94:E19-E20). The correct order is:

These articles have been corrected online.

Cyanoacrylates are widely used in adhesive products, with applications ranging from household products to nail and beauty salons and even dentistry. A topical skin adhesive containing 2-octyl cyanoacrylate was approved in 1998 for topical application for closure of skin edges of wounds from surgical incisions.¹ Usually cyanoacrylates are not strong sensitizers, and despite their extensive use, there have been relatively few reports of associated allergic contact dermatitis (ACD).^2-5 We report 4 cases of ACD to 2-octyl cyanoacrylate used in postsurgical wound closures as confirmed by patch tests.

Case Reports

Patient 1

A 33-year-old woman presented with an intensely pruritic peri-incisional rash on the lower back and right buttock of 1 week’s duration. The eruption started roughly 1 week following surgical implantation of a spinal cord stimulator for treatment of chronic back pain. Both incisions made during the implantation were closed with 2-octyl cyanoacrylate. The patient denied any prior exposure to topical skin adhesives or any history of contact dermatitis to nickel or other materials. The patient did not dress the wounds and did not apply topical agents to the area.

Physical examination revealed 6- to 8-cm linear surgical scars on the midline lumbar back and superior right buttock with surrounding excoriated erythematous papules coalescing into plaques consistent with acute eczematous dermatitis (Figure 1). Similar papules and plaques were scattered across the abdomen and chest. She was given triamcinolone acetonide ointment 0.1% twice daily and hydroxyzine pamoate 25 mg 3 times daily for itching. The surgical wounds healed within 2 weeks of presentation with postinflammatory hyperpigmentation surrounding the scars.

Figure 1. Surgical scars with surrounding excoriated erythematous papules coalescing into plaques on the midline lumbar back (A) and superior right buttock (B).

Six weeks later she underwent patch testing to confirm the diagnosis. She was screened using the North American Contact Dermatitis Group standard 65-allergen series and a miscellaneous tray including hardware obtained from the spinal cord stimulator device manufacturer. A use test to 2-octyl cyanoacrylate also was performed. At 96 hours, true positives included cinnamic aldehyde (1+), nickel (1+), bacitracin (1+), fragrance mix (2+), disperse blue dyes 106 and 124 (2+), and 2-octyl cyanoacrylate (3+)(1+=weak positive; 2+=strong positive; 3+=extreme reaction). There was no response to any components of the device. The pattern of dermatitis and positive patch-test results strongly supported the diagnosis of ACD to 2-octyl cyanoacrylate.

Patients 2, 3, and 4

Three patients—a 65-year-old woman, a 35-year-old woman, and a 44-year-old woman—presented to us with eczematous dermatitis at laparoscopic portal sites that were closed with 2-octyl cyanoacrylate (Figures 2 and 3). They presented approximately 1 week following laparoscopic Nissen fundoplication, laparoscopic left hepatectomy, and laparoscopic cholecystectomy, respectively. None of these  3 patients had been using any topical medications. All of them had a positive reaction (2+) to 2-octyl cyanoacrylate on use testing. Interestingly, use tests for 2 other cyanoacrylates containing 2-butyl cyanoacrylate were negative in 2 patients.

Figure 2. Acute eczematous plaques at wound closures.

Figure 3. Coalescing acute eczematous plaques focused at wound closures.

Although patient 1 reported no prior exposure to 2-octyl cyanoacrylate, these 3 additional patients reported prior exposure with no reaction. Other possible contact allergens associated with wound closure included iodine, topical antibiotics, and dressing tape.

Comment

Contact allergies to acrylates are not uncommon. In a series of 275 patients, Kanerva et al⁶ found that 17.5% of patients had an allergic reaction to at least 1 acrylate or methacrylate. In the same series, no allergic reactions to cyanoacrylates were noted.⁶ The role of methacrylates in the development of occupational ACD and irritant dermatitis has been well characterized among dentists, orthopedic surgeons, beauticians, and industrial workers who are commonly exposed to these agents.^7-12 Partially because of their longer carbon chains, cyanoacrylates have reduced toxicity and improved bonding strength as well as flexibility. Given their availability and the ease and speed of their use, skin adhesives have become widely used in the closure of surgical wounds.^13-16

Postoperative contact dermatitis is problematic, as patients are exposed to many potential allergens during surgery. In our clinical practice, the most common allergens causing ACD associated with surgery are iodine, topical antibiotics (ie, bacitracin, neomycin), tape adhesives, suture materials, and less commonly surgical hardware. Although they are rarely reported, contact allergies to skin adhesives such as cyanoacrylates are of particular importance because they may complicate surgical wounds, leading to dehiscence, infection, and scarring, among other complications. In our patients, there were no adverse outcomes in wound healing with the exception of postinflammatory hyperpigmentation.

Under ideal conditions, 2-octyl cyanoacrylate generally is not a strong sensitizer; however, application to open wounds or thinner skin such as the eyelids may permit exposure of antigen-presenting cells to cyanoacrylate monomers, thereby initiating sensitization. Postsurgical occlusive dressings, which often are left in place for 7 to 14 days, also may contribute to sensitization. The role of the degradation of skin adhesive products in the development of contact dermatitis is unknown.

Management of ACD from skin adhesives should involve the immediate removal of any remaining adhesive. One manufacturer recommends removal of the product using acetone or petroleum jelly.¹ In our experience, rubbing the adhesive with 2×2-in gauze pads or using forceps have been successful methods for removal. The use of petroleum jelly prior to rubbing with gauze also can aid in removal of the adhesive. Warm water soaks and soap also may be helpful but are not expected to immediately loosen the bond. A mid-potency steroid ointment such as triamcinolone may be effective in treating dermatitis, though the use of higher-potency steroids such as clobetasol may be needed for severe reactions.^1,2

As members of the cyano group, cyanoacrylates are highly reactive molecules that polymerize and rapidly bind to the stratum corneum when they come in contact with traces of water. During polymerization, the individual constituents or monomer cyanoacrylate molecules are joined into a polymer chain, which should be trapped by keratinocytes and not reach immunomodulators^2,10; however, as postulated during the first report of contact dermatitis, an arid environment could delay polymerization and increase the risk of sensitization.² The first report was made in Las Vegas, Nevada,² and our cases presented in San Antonio, Texas.

There currently are 2 main cutaneous adhesives containing cyanoacrylate on the market, including 2-octyl cyanoacrylate and 2-butyl cyanoacrylate. These products are known by various trade names and differ primarily in the length of the carbon chain in the cyanoacrylate. A dye is added to allow better visibility of the glue during application, and a plasticizer increases viscosity and accelerates polymerization. The 2 most widely used products contain the same dye (D&C Violet No. 2) and similar but proprietary plasticizers.

Figure 4. When conducting use tests to determine if plasticizers or dyes in acrylate adhesive products may be potential allergens, a reaction only to product 1 would suggest that 2-octyl cyanoacrylate is to blame. A reaction to products 2 and 3 but not product 1 would suggest 2-butyl cyanoacrylate as a sensitizer, while a reaction to products 1 and 2 but not product 3 would suggest that the dye is responsible.

Although plasticizers and dyes may be potential contact allergens, we postulated that the cyanoacrylate was the responsible sensitizer in our cases. Because the individual ingredients were not readily available for use testing, we devised a logical method to attempt to determine the specific component of the skin adhesive that was responsible for contact sensitization (Figure 4). Patients 3 and 4 in our series were tested using this method and were found to be sensitive to the product containing 2-octyl cyanoacrylate but not the products containing 2-butyl cyanoacrylate.

Conclusion

Given the many advantages of cyanoacrylates, it is likely that their use in skin adhesive products will continue to increase. Our 4 patients may represent a rise in the incidence of ACD associated with increased use of skin adhesives, but it is important to look critically at this agent when patients present with postoperative pruritus in the absence of topical bacitracin or neomycin use and surgical dressing irritation. By using the technique we described, it is possible to identify the component responsible for the reaction; however, in the future, the exact mechanisms of sensitization and the specific components should be further elucidated by researchers working in conjunction with the manufacturers. Use testing on abraded skin and/or under occlusive dressings more closely mimics the initial exposure and may have a role in determining true allergy.

Cyanoacrylates are widely used in adhesive products, with applications ranging from household products to nail and beauty salons and even dentistry. A topical skin adhesive containing 2-octyl cyanoacrylate was approved in 1998 for topical application for closure of skin edges of wounds from surgical incisions.¹ Usually cyanoacrylates are not strong sensitizers, and despite their extensive use, there have been relatively few reports of associated allergic contact dermatitis (ACD).^2-5 We report 4 cases of ACD to 2-octyl cyanoacrylate used in postsurgical wound closures as confirmed by patch tests.

Case Reports

Patient 1

A 33-year-old woman presented with an intensely pruritic peri-incisional rash on the lower back and right buttock of 1 week’s duration. The eruption started roughly 1 week following surgical implantation of a spinal cord stimulator for treatment of chronic back pain. Both incisions made during the implantation were closed with 2-octyl cyanoacrylate. The patient denied any prior exposure to topical skin adhesives or any history of contact dermatitis to nickel or other materials. The patient did not dress the wounds and did not apply topical agents to the area.

Physical examination revealed 6- to 8-cm linear surgical scars on the midline lumbar back and superior right buttock with surrounding excoriated erythematous papules coalescing into plaques consistent with acute eczematous dermatitis (Figure 1). Similar papules and plaques were scattered across the abdomen and chest. She was given triamcinolone acetonide ointment 0.1% twice daily and hydroxyzine pamoate 25 mg 3 times daily for itching. The surgical wounds healed within 2 weeks of presentation with postinflammatory hyperpigmentation surrounding the scars.

Figure 1. Surgical scars with surrounding excoriated erythematous papules coalescing into plaques on the midline lumbar back (A) and superior right buttock (B).

Six weeks later she underwent patch testing to confirm the diagnosis. She was screened using the North American Contact Dermatitis Group standard 65-allergen series and a miscellaneous tray including hardware obtained from the spinal cord stimulator device manufacturer. A use test to 2-octyl cyanoacrylate also was performed. At 96 hours, true positives included cinnamic aldehyde (1+), nickel (1+), bacitracin (1+), fragrance mix (2+), disperse blue dyes 106 and 124 (2+), and 2-octyl cyanoacrylate (3+)(1+=weak positive; 2+=strong positive; 3+=extreme reaction). There was no response to any components of the device. The pattern of dermatitis and positive patch-test results strongly supported the diagnosis of ACD to 2-octyl cyanoacrylate.

Patients 2, 3, and 4

Three patients—a 65-year-old woman, a 35-year-old woman, and a 44-year-old woman—presented to us with eczematous dermatitis at laparoscopic portal sites that were closed with 2-octyl cyanoacrylate (Figures 2 and 3). They presented approximately 1 week following laparoscopic Nissen fundoplication, laparoscopic left hepatectomy, and laparoscopic cholecystectomy, respectively. None of these  3 patients had been using any topical medications. All of them had a positive reaction (2+) to 2-octyl cyanoacrylate on use testing. Interestingly, use tests for 2 other cyanoacrylates containing 2-butyl cyanoacrylate were negative in 2 patients.

Figure 2. Acute eczematous plaques at wound closures.

Figure 3. Coalescing acute eczematous plaques focused at wound closures.

Although patient 1 reported no prior exposure to 2-octyl cyanoacrylate, these 3 additional patients reported prior exposure with no reaction. Other possible contact allergens associated with wound closure included iodine, topical antibiotics, and dressing tape.

Comment

Contact allergies to acrylates are not uncommon. In a series of 275 patients, Kanerva et al⁶ found that 17.5% of patients had an allergic reaction to at least 1 acrylate or methacrylate. In the same series, no allergic reactions to cyanoacrylates were noted.⁶ The role of methacrylates in the development of occupational ACD and irritant dermatitis has been well characterized among dentists, orthopedic surgeons, beauticians, and industrial workers who are commonly exposed to these agents.^7-12 Partially because of their longer carbon chains, cyanoacrylates have reduced toxicity and improved bonding strength as well as flexibility. Given their availability and the ease and speed of their use, skin adhesives have become widely used in the closure of surgical wounds.^13-16

Postoperative contact dermatitis is problematic, as patients are exposed to many potential allergens during surgery. In our clinical practice, the most common allergens causing ACD associated with surgery are iodine, topical antibiotics (ie, bacitracin, neomycin), tape adhesives, suture materials, and less commonly surgical hardware. Although they are rarely reported, contact allergies to skin adhesives such as cyanoacrylates are of particular importance because they may complicate surgical wounds, leading to dehiscence, infection, and scarring, among other complications. In our patients, there were no adverse outcomes in wound healing with the exception of postinflammatory hyperpigmentation.

Under ideal conditions, 2-octyl cyanoacrylate generally is not a strong sensitizer; however, application to open wounds or thinner skin such as the eyelids may permit exposure of antigen-presenting cells to cyanoacrylate monomers, thereby initiating sensitization. Postsurgical occlusive dressings, which often are left in place for 7 to 14 days, also may contribute to sensitization. The role of the degradation of skin adhesive products in the development of contact dermatitis is unknown.

Management of ACD from skin adhesives should involve the immediate removal of any remaining adhesive. One manufacturer recommends removal of the product using acetone or petroleum jelly.¹ In our experience, rubbing the adhesive with 2×2-in gauze pads or using forceps have been successful methods for removal. The use of petroleum jelly prior to rubbing with gauze also can aid in removal of the adhesive. Warm water soaks and soap also may be helpful but are not expected to immediately loosen the bond. A mid-potency steroid ointment such as triamcinolone may be effective in treating dermatitis, though the use of higher-potency steroids such as clobetasol may be needed for severe reactions.^1,2

As members of the cyano group, cyanoacrylates are highly reactive molecules that polymerize and rapidly bind to the stratum corneum when they come in contact with traces of water. During polymerization, the individual constituents or monomer cyanoacrylate molecules are joined into a polymer chain, which should be trapped by keratinocytes and not reach immunomodulators^2,10; however, as postulated during the first report of contact dermatitis, an arid environment could delay polymerization and increase the risk of sensitization.² The first report was made in Las Vegas, Nevada,² and our cases presented in San Antonio, Texas.

There currently are 2 main cutaneous adhesives containing cyanoacrylate on the market, including 2-octyl cyanoacrylate and 2-butyl cyanoacrylate. These products are known by various trade names and differ primarily in the length of the carbon chain in the cyanoacrylate. A dye is added to allow better visibility of the glue during application, and a plasticizer increases viscosity and accelerates polymerization. The 2 most widely used products contain the same dye (D&C Violet No. 2) and similar but proprietary plasticizers.

Figure 4. When conducting use tests to determine if plasticizers or dyes in acrylate adhesive products may be potential allergens, a reaction only to product 1 would suggest that 2-octyl cyanoacrylate is to blame. A reaction to products 2 and 3 but not product 1 would suggest 2-butyl cyanoacrylate as a sensitizer, while a reaction to products 1 and 2 but not product 3 would suggest that the dye is responsible.

Although plasticizers and dyes may be potential contact allergens, we postulated that the cyanoacrylate was the responsible sensitizer in our cases. Because the individual ingredients were not readily available for use testing, we devised a logical method to attempt to determine the specific component of the skin adhesive that was responsible for contact sensitization (Figure 4). Patients 3 and 4 in our series were tested using this method and were found to be sensitive to the product containing 2-octyl cyanoacrylate but not the products containing 2-butyl cyanoacrylate.

Conclusion

Given the many advantages of cyanoacrylates, it is likely that their use in skin adhesive products will continue to increase. Our 4 patients may represent a rise in the incidence of ACD associated with increased use of skin adhesives, but it is important to look critically at this agent when patients present with postoperative pruritus in the absence of topical bacitracin or neomycin use and surgical dressing irritation. By using the technique we described, it is possible to identify the component responsible for the reaction; however, in the future, the exact mechanisms of sensitization and the specific components should be further elucidated by researchers working in conjunction with the manufacturers. Use testing on abraded skin and/or under occlusive dressings more closely mimics the initial exposure and may have a role in determining true allergy.

Cyanoacrylates are widely used in adhesive products, with applications ranging from household products to nail and beauty salons and even dentistry. A topical skin adhesive containing 2-octyl cyanoacrylate was approved in 1998 for topical application for closure of skin edges of wounds from surgical incisions.¹ Usually cyanoacrylates are not strong sensitizers, and despite their extensive use, there have been relatively few reports of associated allergic contact dermatitis (ACD).^2-5 We report 4 cases of ACD to 2-octyl cyanoacrylate used in postsurgical wound closures as confirmed by patch tests.

Case Reports

Patient 1

A 33-year-old woman presented with an intensely pruritic peri-incisional rash on the lower back and right buttock of 1 week’s duration. The eruption started roughly 1 week following surgical implantation of a spinal cord stimulator for treatment of chronic back pain. Both incisions made during the implantation were closed with 2-octyl cyanoacrylate. The patient denied any prior exposure to topical skin adhesives or any history of contact dermatitis to nickel or other materials. The patient did not dress the wounds and did not apply topical agents to the area.

Physical examination revealed 6- to 8-cm linear surgical scars on the midline lumbar back and superior right buttock with surrounding excoriated erythematous papules coalescing into plaques consistent with acute eczematous dermatitis (Figure 1). Similar papules and plaques were scattered across the abdomen and chest. She was given triamcinolone acetonide ointment 0.1% twice daily and hydroxyzine pamoate 25 mg 3 times daily for itching. The surgical wounds healed within 2 weeks of presentation with postinflammatory hyperpigmentation surrounding the scars.

Figure 1. Surgical scars with surrounding excoriated erythematous papules coalescing into plaques on the midline lumbar back (A) and superior right buttock (B).

Six weeks later she underwent patch testing to confirm the diagnosis. She was screened using the North American Contact Dermatitis Group standard 65-allergen series and a miscellaneous tray including hardware obtained from the spinal cord stimulator device manufacturer. A use test to 2-octyl cyanoacrylate also was performed. At 96 hours, true positives included cinnamic aldehyde (1+), nickel (1+), bacitracin (1+), fragrance mix (2+), disperse blue dyes 106 and 124 (2+), and 2-octyl cyanoacrylate (3+)(1+=weak positive; 2+=strong positive; 3+=extreme reaction). There was no response to any components of the device. The pattern of dermatitis and positive patch-test results strongly supported the diagnosis of ACD to 2-octyl cyanoacrylate.

Patients 2, 3, and 4

Three patients—a 65-year-old woman, a 35-year-old woman, and a 44-year-old woman—presented to us with eczematous dermatitis at laparoscopic portal sites that were closed with 2-octyl cyanoacrylate (Figures 2 and 3). They presented approximately 1 week following laparoscopic Nissen fundoplication, laparoscopic left hepatectomy, and laparoscopic cholecystectomy, respectively. None of these  3 patients had been using any topical medications. All of them had a positive reaction (2+) to 2-octyl cyanoacrylate on use testing. Interestingly, use tests for 2 other cyanoacrylates containing 2-butyl cyanoacrylate were negative in 2 patients.

Figure 2. Acute eczematous plaques at wound closures.

Figure 3. Coalescing acute eczematous plaques focused at wound closures.

Although patient 1 reported no prior exposure to 2-octyl cyanoacrylate, these 3 additional patients reported prior exposure with no reaction. Other possible contact allergens associated with wound closure included iodine, topical antibiotics, and dressing tape.

Comment

Contact allergies to acrylates are not uncommon. In a series of 275 patients, Kanerva et al⁶ found that 17.5% of patients had an allergic reaction to at least 1 acrylate or methacrylate. In the same series, no allergic reactions to cyanoacrylates were noted.⁶ The role of methacrylates in the development of occupational ACD and irritant dermatitis has been well characterized among dentists, orthopedic surgeons, beauticians, and industrial workers who are commonly exposed to these agents.^7-12 Partially because of their longer carbon chains, cyanoacrylates have reduced toxicity and improved bonding strength as well as flexibility. Given their availability and the ease and speed of their use, skin adhesives have become widely used in the closure of surgical wounds.^13-16

Postoperative contact dermatitis is problematic, as patients are exposed to many potential allergens during surgery. In our clinical practice, the most common allergens causing ACD associated with surgery are iodine, topical antibiotics (ie, bacitracin, neomycin), tape adhesives, suture materials, and less commonly surgical hardware. Although they are rarely reported, contact allergies to skin adhesives such as cyanoacrylates are of particular importance because they may complicate surgical wounds, leading to dehiscence, infection, and scarring, among other complications. In our patients, there were no adverse outcomes in wound healing with the exception of postinflammatory hyperpigmentation.

Under ideal conditions, 2-octyl cyanoacrylate generally is not a strong sensitizer; however, application to open wounds or thinner skin such as the eyelids may permit exposure of antigen-presenting cells to cyanoacrylate monomers, thereby initiating sensitization. Postsurgical occlusive dressings, which often are left in place for 7 to 14 days, also may contribute to sensitization. The role of the degradation of skin adhesive products in the development of contact dermatitis is unknown.

Management of ACD from skin adhesives should involve the immediate removal of any remaining adhesive. One manufacturer recommends removal of the product using acetone or petroleum jelly.¹ In our experience, rubbing the adhesive with 2×2-in gauze pads or using forceps have been successful methods for removal. The use of petroleum jelly prior to rubbing with gauze also can aid in removal of the adhesive. Warm water soaks and soap also may be helpful but are not expected to immediately loosen the bond. A mid-potency steroid ointment such as triamcinolone may be effective in treating dermatitis, though the use of higher-potency steroids such as clobetasol may be needed for severe reactions.^1,2

As members of the cyano group, cyanoacrylates are highly reactive molecules that polymerize and rapidly bind to the stratum corneum when they come in contact with traces of water. During polymerization, the individual constituents or monomer cyanoacrylate molecules are joined into a polymer chain, which should be trapped by keratinocytes and not reach immunomodulators^2,10; however, as postulated during the first report of contact dermatitis, an arid environment could delay polymerization and increase the risk of sensitization.² The first report was made in Las Vegas, Nevada,² and our cases presented in San Antonio, Texas.

There currently are 2 main cutaneous adhesives containing cyanoacrylate on the market, including 2-octyl cyanoacrylate and 2-butyl cyanoacrylate. These products are known by various trade names and differ primarily in the length of the carbon chain in the cyanoacrylate. A dye is added to allow better visibility of the glue during application, and a plasticizer increases viscosity and accelerates polymerization. The 2 most widely used products contain the same dye (D&C Violet No. 2) and similar but proprietary plasticizers.

Figure 4. When conducting use tests to determine if plasticizers or dyes in acrylate adhesive products may be potential allergens, a reaction only to product 1 would suggest that 2-octyl cyanoacrylate is to blame. A reaction to products 2 and 3 but not product 1 would suggest 2-butyl cyanoacrylate as a sensitizer, while a reaction to products 1 and 2 but not product 3 would suggest that the dye is responsible.

Although plasticizers and dyes may be potential contact allergens, we postulated that the cyanoacrylate was the responsible sensitizer in our cases. Because the individual ingredients were not readily available for use testing, we devised a logical method to attempt to determine the specific component of the skin adhesive that was responsible for contact sensitization (Figure 4). Patients 3 and 4 in our series were tested using this method and were found to be sensitive to the product containing 2-octyl cyanoacrylate but not the products containing 2-butyl cyanoacrylate.

Conclusion

Given the many advantages of cyanoacrylates, it is likely that their use in skin adhesive products will continue to increase. Our 4 patients may represent a rise in the incidence of ACD associated with increased use of skin adhesives, but it is important to look critically at this agent when patients present with postoperative pruritus in the absence of topical bacitracin or neomycin use and surgical dressing irritation. By using the technique we described, it is possible to identify the component responsible for the reaction; however, in the future, the exact mechanisms of sensitization and the specific components should be further elucidated by researchers working in conjunction with the manufacturers. Use testing on abraded skin and/or under occlusive dressings more closely mimics the initial exposure and may have a role in determining true allergy.

A drug-coated angioplasty balloon catheter has been approved for treating peripheral artery disease, the first such device approved for this use, the Food and Drug Administration announced on October 10.

The device is the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB), manufactured by Lutonix; its outer surface is coated with paclitaxel, “which may help to prevent” restenosis after the angioplasty procedure, according to the FDA statement announcing the approval. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the statement.

Approval was based on the results of three clinical trials and nonclinical testing:

• A randomized, multicenter study of 101 people in Europe, which found that after 6 months, no further treatment for PAD was needed in almost 72% of the patients treated with Lutonix DCB, compared with almost 50% of those treated with conventional balloon angioplasty.

• A single-blind, multicenter, randomized study of 476 people in the United States and Europe, which found that 65% of those randomized to treatment with Lutonix DCB had no restenosis at 12 months, compared with roughly 53% of those randomized to treatment with conventional balloon angioplasty.

• A single-arm, ongoing study that is further evaluating safety and effectiveness in 657 people treated with the device in the United States and Europe, which, at the time of approval, “show that there have been no unanticipated device- or drug-related adverse events,” the FDA said.

These studies also indicated that the safety of Lutonix DCB was comparable to conventional balloon angioplasty. The most common major adverse events included additional intervention, pain as a result of poor blood flow, narrowing of arteries that were not treated, chest pain, and abnormal growth of tissue.

Contraindications include women who are breastfeeding, pregnant, or plan to become pregnant; and men who plan to father children.

The company is required by the FDA to conduct two postapproval studies, the ongoing 5-year study of 657 patients, and a randomized, single-blind, multicenter study that will evaluate safety and effectiveness of the device in women in the United States, “due to differences in observed outcomes in this group as compared to outcomes for the general study population,” according to the FDA.

The device was reviewed at an FDA advisory panel meeting in June.

emechcatie@frontlinemedcom.com

A drug-coated angioplasty balloon catheter has been approved for treating peripheral artery disease, the first such device approved for this use, the Food and Drug Administration announced on October 10.

The device is the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB), manufactured by Lutonix; its outer surface is coated with paclitaxel, “which may help to prevent” restenosis after the angioplasty procedure, according to the FDA statement announcing the approval. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the statement.

Approval was based on the results of three clinical trials and nonclinical testing:

• A randomized, multicenter study of 101 people in Europe, which found that after 6 months, no further treatment for PAD was needed in almost 72% of the patients treated with Lutonix DCB, compared with almost 50% of those treated with conventional balloon angioplasty.

• A single-blind, multicenter, randomized study of 476 people in the United States and Europe, which found that 65% of those randomized to treatment with Lutonix DCB had no restenosis at 12 months, compared with roughly 53% of those randomized to treatment with conventional balloon angioplasty.

• A single-arm, ongoing study that is further evaluating safety and effectiveness in 657 people treated with the device in the United States and Europe, which, at the time of approval, “show that there have been no unanticipated device- or drug-related adverse events,” the FDA said.

These studies also indicated that the safety of Lutonix DCB was comparable to conventional balloon angioplasty. The most common major adverse events included additional intervention, pain as a result of poor blood flow, narrowing of arteries that were not treated, chest pain, and abnormal growth of tissue.

Contraindications include women who are breastfeeding, pregnant, or plan to become pregnant; and men who plan to father children.

The company is required by the FDA to conduct two postapproval studies, the ongoing 5-year study of 657 patients, and a randomized, single-blind, multicenter study that will evaluate safety and effectiveness of the device in women in the United States, “due to differences in observed outcomes in this group as compared to outcomes for the general study population,” according to the FDA.

The device was reviewed at an FDA advisory panel meeting in June.

emechcatie@frontlinemedcom.com

A drug-coated angioplasty balloon catheter has been approved for treating peripheral artery disease, the first such device approved for this use, the Food and Drug Administration announced on October 10.

The device is the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB), manufactured by Lutonix; its outer surface is coated with paclitaxel, “which may help to prevent” restenosis after the angioplasty procedure, according to the FDA statement announcing the approval. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the statement.

Approval was based on the results of three clinical trials and nonclinical testing:

• A randomized, multicenter study of 101 people in Europe, which found that after 6 months, no further treatment for PAD was needed in almost 72% of the patients treated with Lutonix DCB, compared with almost 50% of those treated with conventional balloon angioplasty.

• A single-blind, multicenter, randomized study of 476 people in the United States and Europe, which found that 65% of those randomized to treatment with Lutonix DCB had no restenosis at 12 months, compared with roughly 53% of those randomized to treatment with conventional balloon angioplasty.

• A single-arm, ongoing study that is further evaluating safety and effectiveness in 657 people treated with the device in the United States and Europe, which, at the time of approval, “show that there have been no unanticipated device- or drug-related adverse events,” the FDA said.

These studies also indicated that the safety of Lutonix DCB was comparable to conventional balloon angioplasty. The most common major adverse events included additional intervention, pain as a result of poor blood flow, narrowing of arteries that were not treated, chest pain, and abnormal growth of tissue.

Contraindications include women who are breastfeeding, pregnant, or plan to become pregnant; and men who plan to father children.

The company is required by the FDA to conduct two postapproval studies, the ongoing 5-year study of 657 patients, and a randomized, single-blind, multicenter study that will evaluate safety and effectiveness of the device in women in the United States, “due to differences in observed outcomes in this group as compared to outcomes for the general study population,” according to the FDA.

The device was reviewed at an FDA advisory panel meeting in June.

emechcatie@frontlinemedcom.com