Practice Management

If you’ve been a hospitalist leader for a few years, you likely are familiar with the specter of the disruptive physician. Most group leaders dread dealing with a hospitalist who exhibits behavior that upsets the group or the hospital staff; fewer meet the task head-on and try to change that behavior; and fewer still enjoy the challenge.

If you fall into one of the first two categories, take comfort in knowing you aren’t alone. But if you know that problem hospitalists are a management challenge, you should seek counsel or training to address such issues when they arise.

Define “Disruptive”

Managers are responsible for maintaining equilibrium in their HM groups, so it’s important to understand what constitutes disruptive behavior. “What it really comes down to is behavior which can impair patient care, collegiality, and the overall work in the hospital,” says Aaron Gottesman, MD, FACP, director of hospitalist services at Staten Island University Hospital in New York. “If a specific physician or other staff member acts in a way that hampers staff satisfaction, patient satisfaction, and obviously care, then that is disruptive.”

Disruptive behavior in the hospital can come from any staff member, not just physicians. Disruptive physicians receive greater attention because their bad behavior is more likely to be noticed and reported. And they do tend to get angry. “Physicians are time-sensitive, and they’re perfectionists,” says Timothy J. Keogh, PhD, assistant professor at the Citadel School of Business Administration in Charleston, S.C., who has researched physicians’ personality traits. “When they’re put in a stressful situation—such as an ED or ICU, where the outcomes may be uncertain and they’re operating on insufficient sleep or under stress—you may see this behavior.”

Although HM is a stressful career path with challenges of its own, Dr. Gottesman says he rarely notices the same level of disruptive behavior as can be found in the ED, OR, or ICU. “I don’t think it occurs among hospitalists any more than among the general physician population,” he says. “Hospitalists are not under the same time constraints; they don’t have as much stress or pressure—or at least they have a different kind.”

So who is responsible for dealing with a physician who behaves badly? In all cases, it should be the individual’s immediate supervisor.

Policy Preparation

The crucial component in dealing with a disruptive employee is to have an official behavior policy that is shared with everyone in your organization. The Joint Commission recently required hospitals to employ a code of conduct that outlines acceptable and unacceptable behavior, and it sets a process for addressing problematic behavior.

“You can bet physicians and nurses know it, including the disruptive individuals,” Dr. Keogh says. “This will make it much easier for executives to enforce.”

Dr. Gottesman relies on his organization’s policy. “It’s absolutely critical to have a sense of direction, to know what’s appropriate and what’s inappropriate, to have a procedure to follow,” he says. “Having policies and protocol in place is also critical for legal protection if the situation escalates. It protects the physician, the staff, the patients, and the institution.”

Dr. Keogh, a faculty member of SHM’s Leadership Academy, recommends that all physician employees learn their code of conduct policy. “To prevent downstream behaviors, when you get a new hire, don’t just give them this statement—read that section to them out loud,” he advises. “This ensures that they notice it, and gives hospitalist executives a much stronger position when something happens.”

 

Face-to-Face Meeting

There are two proven methods to successfully deal with disruptive behavior: 1) React to it immediately, and 2) follow up to ensure it doesn’t happen again. When you receive a complaint about a disruptive hospitalist, gather all the information you can on the incident and schedule a meeting to discuss it with the party accused of poor behavior.

“The first occurrence should result in an informal conversation. ‘You stepped over the line here, and we have to make sure it doesn’t happen again,’ ” Dr. Keogh says. He recommends that a human resources staffer be present at this meeting, and supervisors should come prepared with documentation.

“You have to sit them down and go over a written document—don’t just talk about word-of-mouth. Go over the documented occurrence of the behavior,” Dr. Keogh explains. “Talk through what they did, and let them know that you both have to find a way to ensure that it doesn’t happen again. They’ll rationalize their behavior at first, but make sure they understand that it’s unacceptable.”

In the case of an allegation or a one-on-one dispute, Dr. Gottesman advises you “clarify both sides before taking any action. I hear both sides of the story, then we find some common ground and work toward a solution.” In his experience, he says, “by and large, most physicians tend to be responsive when spoken to in a constructive, positive fashion. Let them know that you’re here to support them, not prosecute them. You need to maintain a professional demeanor.”

Dr. Keogh says oftentimes the first disciplinary meeting will be enough to end the disruptive behavior. If the same individual has another incident, schedule a second meeting and emphasize the seriousness of the infraction and disciplinary measures. You might want to have a senior manager, such as your chief medical officer, join the discussion. Officially document the problem and identify the consequences if the employee is disruptive again.

Followup Is Key

Another key to quashing disruptive behavior is doing your part to ensure it doesn’t happen again. “The problem is that the impact is residual on the people around that individual, whether it’s the nurses or patients,” Dr. Keogh says. “The results are avoidance and silence.”

Supervisors should follow up on the disruptive behavior by placing themselves in the problem employee’s way; doing so will let you see how they work and how others react to them, and it will show that you’re keeping an eye on them. “The [manager] has to show ongoing oversight of that individual, with occasional walks in the [hospital halls] and ongoing verbal encouragement, to show that someone is paying attention,” Dr. Keogh says. “They can fall back into bad behaviors if they think no one is watching.” Positive recognition of good behavior and outcomes (i.e., improved patient satisfaction) also helps reinforce your followup.

 

Depending on the individual and the situation, dealing with a disruptive behavior can be a long-term, never-ending job. But it’s a necessary one.

“There has to be zero tolerance,” Dr. Gottesman says. “People should be comfortable and confident with reporting this behavior. It should not be accepted as a normal part of work to put up with it. And they should know that the situation will be looked at objectively, and both sides will be heard.” TH

Jane Jerrard is a freelance writer based in Chicago.

If you’ve been a hospitalist leader for a few years, you likely are familiar with the specter of the disruptive physician. Most group leaders dread dealing with a hospitalist who exhibits behavior that upsets the group or the hospital staff; fewer meet the task head-on and try to change that behavior; and fewer still enjoy the challenge.

If you fall into one of the first two categories, take comfort in knowing you aren’t alone. But if you know that problem hospitalists are a management challenge, you should seek counsel or training to address such issues when they arise.

Define “Disruptive”

Managers are responsible for maintaining equilibrium in their HM groups, so it’s important to understand what constitutes disruptive behavior. “What it really comes down to is behavior which can impair patient care, collegiality, and the overall work in the hospital,” says Aaron Gottesman, MD, FACP, director of hospitalist services at Staten Island University Hospital in New York. “If a specific physician or other staff member acts in a way that hampers staff satisfaction, patient satisfaction, and obviously care, then that is disruptive.”

Disruptive behavior in the hospital can come from any staff member, not just physicians. Disruptive physicians receive greater attention because their bad behavior is more likely to be noticed and reported. And they do tend to get angry. “Physicians are time-sensitive, and they’re perfectionists,” says Timothy J. Keogh, PhD, assistant professor at the Citadel School of Business Administration in Charleston, S.C., who has researched physicians’ personality traits. “When they’re put in a stressful situation—such as an ED or ICU, where the outcomes may be uncertain and they’re operating on insufficient sleep or under stress—you may see this behavior.”

Although HM is a stressful career path with challenges of its own, Dr. Gottesman says he rarely notices the same level of disruptive behavior as can be found in the ED, OR, or ICU. “I don’t think it occurs among hospitalists any more than among the general physician population,” he says. “Hospitalists are not under the same time constraints; they don’t have as much stress or pressure—or at least they have a different kind.”

So who is responsible for dealing with a physician who behaves badly? In all cases, it should be the individual’s immediate supervisor.

Policy Preparation

The crucial component in dealing with a disruptive employee is to have an official behavior policy that is shared with everyone in your organization. The Joint Commission recently required hospitals to employ a code of conduct that outlines acceptable and unacceptable behavior, and it sets a process for addressing problematic behavior.

“You can bet physicians and nurses know it, including the disruptive individuals,” Dr. Keogh says. “This will make it much easier for executives to enforce.”

Dr. Gottesman relies on his organization’s policy. “It’s absolutely critical to have a sense of direction, to know what’s appropriate and what’s inappropriate, to have a procedure to follow,” he says. “Having policies and protocol in place is also critical for legal protection if the situation escalates. It protects the physician, the staff, the patients, and the institution.”

Dr. Keogh, a faculty member of SHM’s Leadership Academy, recommends that all physician employees learn their code of conduct policy. “To prevent downstream behaviors, when you get a new hire, don’t just give them this statement—read that section to them out loud,” he advises. “This ensures that they notice it, and gives hospitalist executives a much stronger position when something happens.”

 

Face-to-Face Meeting

There are two proven methods to successfully deal with disruptive behavior: 1) React to it immediately, and 2) follow up to ensure it doesn’t happen again. When you receive a complaint about a disruptive hospitalist, gather all the information you can on the incident and schedule a meeting to discuss it with the party accused of poor behavior.

“The first occurrence should result in an informal conversation. ‘You stepped over the line here, and we have to make sure it doesn’t happen again,’ ” Dr. Keogh says. He recommends that a human resources staffer be present at this meeting, and supervisors should come prepared with documentation.

“You have to sit them down and go over a written document—don’t just talk about word-of-mouth. Go over the documented occurrence of the behavior,” Dr. Keogh explains. “Talk through what they did, and let them know that you both have to find a way to ensure that it doesn’t happen again. They’ll rationalize their behavior at first, but make sure they understand that it’s unacceptable.”

In the case of an allegation or a one-on-one dispute, Dr. Gottesman advises you “clarify both sides before taking any action. I hear both sides of the story, then we find some common ground and work toward a solution.” In his experience, he says, “by and large, most physicians tend to be responsive when spoken to in a constructive, positive fashion. Let them know that you’re here to support them, not prosecute them. You need to maintain a professional demeanor.”

Dr. Keogh says oftentimes the first disciplinary meeting will be enough to end the disruptive behavior. If the same individual has another incident, schedule a second meeting and emphasize the seriousness of the infraction and disciplinary measures. You might want to have a senior manager, such as your chief medical officer, join the discussion. Officially document the problem and identify the consequences if the employee is disruptive again.

Followup Is Key

Another key to quashing disruptive behavior is doing your part to ensure it doesn’t happen again. “The problem is that the impact is residual on the people around that individual, whether it’s the nurses or patients,” Dr. Keogh says. “The results are avoidance and silence.”

Supervisors should follow up on the disruptive behavior by placing themselves in the problem employee’s way; doing so will let you see how they work and how others react to them, and it will show that you’re keeping an eye on them. “The [manager] has to show ongoing oversight of that individual, with occasional walks in the [hospital halls] and ongoing verbal encouragement, to show that someone is paying attention,” Dr. Keogh says. “They can fall back into bad behaviors if they think no one is watching.” Positive recognition of good behavior and outcomes (i.e., improved patient satisfaction) also helps reinforce your followup.

 

Depending on the individual and the situation, dealing with a disruptive behavior can be a long-term, never-ending job. But it’s a necessary one.

“There has to be zero tolerance,” Dr. Gottesman says. “People should be comfortable and confident with reporting this behavior. It should not be accepted as a normal part of work to put up with it. And they should know that the situation will be looked at objectively, and both sides will be heard.” TH

Jane Jerrard is a freelance writer based in Chicago.

If you’ve been a hospitalist leader for a few years, you likely are familiar with the specter of the disruptive physician. Most group leaders dread dealing with a hospitalist who exhibits behavior that upsets the group or the hospital staff; fewer meet the task head-on and try to change that behavior; and fewer still enjoy the challenge.

If you fall into one of the first two categories, take comfort in knowing you aren’t alone. But if you know that problem hospitalists are a management challenge, you should seek counsel or training to address such issues when they arise.

Define “Disruptive”

Managers are responsible for maintaining equilibrium in their HM groups, so it’s important to understand what constitutes disruptive behavior. “What it really comes down to is behavior which can impair patient care, collegiality, and the overall work in the hospital,” says Aaron Gottesman, MD, FACP, director of hospitalist services at Staten Island University Hospital in New York. “If a specific physician or other staff member acts in a way that hampers staff satisfaction, patient satisfaction, and obviously care, then that is disruptive.”

Disruptive behavior in the hospital can come from any staff member, not just physicians. Disruptive physicians receive greater attention because their bad behavior is more likely to be noticed and reported. And they do tend to get angry. “Physicians are time-sensitive, and they’re perfectionists,” says Timothy J. Keogh, PhD, assistant professor at the Citadel School of Business Administration in Charleston, S.C., who has researched physicians’ personality traits. “When they’re put in a stressful situation—such as an ED or ICU, where the outcomes may be uncertain and they’re operating on insufficient sleep or under stress—you may see this behavior.”

Although HM is a stressful career path with challenges of its own, Dr. Gottesman says he rarely notices the same level of disruptive behavior as can be found in the ED, OR, or ICU. “I don’t think it occurs among hospitalists any more than among the general physician population,” he says. “Hospitalists are not under the same time constraints; they don’t have as much stress or pressure—or at least they have a different kind.”

So who is responsible for dealing with a physician who behaves badly? In all cases, it should be the individual’s immediate supervisor.

Policy Preparation

The crucial component in dealing with a disruptive employee is to have an official behavior policy that is shared with everyone in your organization. The Joint Commission recently required hospitals to employ a code of conduct that outlines acceptable and unacceptable behavior, and it sets a process for addressing problematic behavior.

“You can bet physicians and nurses know it, including the disruptive individuals,” Dr. Keogh says. “This will make it much easier for executives to enforce.”

Dr. Gottesman relies on his organization’s policy. “It’s absolutely critical to have a sense of direction, to know what’s appropriate and what’s inappropriate, to have a procedure to follow,” he says. “Having policies and protocol in place is also critical for legal protection if the situation escalates. It protects the physician, the staff, the patients, and the institution.”

Dr. Keogh, a faculty member of SHM’s Leadership Academy, recommends that all physician employees learn their code of conduct policy. “To prevent downstream behaviors, when you get a new hire, don’t just give them this statement—read that section to them out loud,” he advises. “This ensures that they notice it, and gives hospitalist executives a much stronger position when something happens.”

 

Face-to-Face Meeting

There are two proven methods to successfully deal with disruptive behavior: 1) React to it immediately, and 2) follow up to ensure it doesn’t happen again. When you receive a complaint about a disruptive hospitalist, gather all the information you can on the incident and schedule a meeting to discuss it with the party accused of poor behavior.

“The first occurrence should result in an informal conversation. ‘You stepped over the line here, and we have to make sure it doesn’t happen again,’ ” Dr. Keogh says. He recommends that a human resources staffer be present at this meeting, and supervisors should come prepared with documentation.

“You have to sit them down and go over a written document—don’t just talk about word-of-mouth. Go over the documented occurrence of the behavior,” Dr. Keogh explains. “Talk through what they did, and let them know that you both have to find a way to ensure that it doesn’t happen again. They’ll rationalize their behavior at first, but make sure they understand that it’s unacceptable.”

In the case of an allegation or a one-on-one dispute, Dr. Gottesman advises you “clarify both sides before taking any action. I hear both sides of the story, then we find some common ground and work toward a solution.” In his experience, he says, “by and large, most physicians tend to be responsive when spoken to in a constructive, positive fashion. Let them know that you’re here to support them, not prosecute them. You need to maintain a professional demeanor.”

Dr. Keogh says oftentimes the first disciplinary meeting will be enough to end the disruptive behavior. If the same individual has another incident, schedule a second meeting and emphasize the seriousness of the infraction and disciplinary measures. You might want to have a senior manager, such as your chief medical officer, join the discussion. Officially document the problem and identify the consequences if the employee is disruptive again.

Followup Is Key

Another key to quashing disruptive behavior is doing your part to ensure it doesn’t happen again. “The problem is that the impact is residual on the people around that individual, whether it’s the nurses or patients,” Dr. Keogh says. “The results are avoidance and silence.”

Supervisors should follow up on the disruptive behavior by placing themselves in the problem employee’s way; doing so will let you see how they work and how others react to them, and it will show that you’re keeping an eye on them. “The [manager] has to show ongoing oversight of that individual, with occasional walks in the [hospital halls] and ongoing verbal encouragement, to show that someone is paying attention,” Dr. Keogh says. “They can fall back into bad behaviors if they think no one is watching.” Positive recognition of good behavior and outcomes (i.e., improved patient satisfaction) also helps reinforce your followup.

 

Depending on the individual and the situation, dealing with a disruptive behavior can be a long-term, never-ending job. But it’s a necessary one.

“There has to be zero tolerance,” Dr. Gottesman says. “People should be comfortable and confident with reporting this behavior. It should not be accepted as a normal part of work to put up with it. And they should know that the situation will be looked at objectively, and both sides will be heard.” TH

Jane Jerrard is a freelance writer based in Chicago.

Product Withdrawal

• Efalizumab (Raptiva), the once-weekly monoclonal antibody used to treat moderate to severe plaque psoriasis, has been withdrawn from the U.S. market due to its association with an increased risk of developing progressive multifocal leukoencephalopathy (PML).1 Four cases of PML have been confirmed, and the manufacturer has decided the risks outweigh the benefits.2

New Generics

• Carbamazepine extended-release (generic Tegretol-XR) tablets (100 mg, 200 mg and 400 mg)3
• Mycophenolate mofetil (generic Cellcept)4

New Drugs, Indications & Dosage Forms

• You might have noticed some difficulty getting pancrelipase products for your patients with exocrine pancreatic insufficiency (EPI), pancreatitis, or cystic fibrosis. Here’s why: Pancreatic enzyme replacement therapies (PERT), pancreatic enzyme products (PEP), pancrelipase products, or EPI products were available prior to the formation of the U.S. Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA) of 1938.
  

  
  

  Until recently, none of these drug products had been marketed under approved new drug applications (NDAs). Since none of the products were subject to the NDA process, they were never subjected to safety, efficacy, bioavailability, or dose-ranging studies.5 The FDA has since decided that these agents must undergo the NDA process and, if approved, will only be available with a prescription.6
  

  
  

  Part of the guidance states that all approved formulations will contain “zero overfill.” In other words, the products will not have a range of lipase (90% to 165%), as they had before. Overfill leads to side effects, including diarrhea, flatulence, hyperuricosuria, hyperuricosemia, and fibrosing colonopathy.
  

  
  

  The new deadline to submit an NDA is April 29, 2010. The FDA has approved its first PEP agent, Creon pancrelipase, under the new guidance. It is expected to be available later this year.7

• Amlodipine, hydrochlorothiazide (HCTZ), and valsartan (Exforge HCT) is the first—and currently only—triple-combination antihypertensive agent to receive FDA approval.8 It can be used in patients already on these three medications, or it can be used as add-on therapy in patients not adequately controlled on two agents. The manufacturer plans to price the agent the same as amlodipine/valsartan (Exforge). Dose options are amlodipine 5 mg/valsartan 160 mg/HCTZ 12.5 mg, up to a maximum of two tablets daily.9
• Bromocriptine (Cycloset) is reformulated in a lower dose that is fast-acting and should be taken in the morning to boost dopamine levels and improve glycemic control in Type 2 diabetes patients.10 The drug is approved for monotherapy, as an adjunct to sulfonylurea therapy, or metformin plus a sulfonylurea. It’s the first diabetes agent to be FDA-approved since the guidance on cardiovascular risks. The most common side effects in clinical trials were nausea and dizziness. It should be used cautiously in patients taking antihypertensive treatment. Women who are nursing should not use it. The launch date is unknown.11
• Golimumab (Simponi), a once-a-month tumor necrosis factor-alpha inhibitor injection, has been FDA-approved for treating moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.12 It carries the same warnings as other agents in the same class, including the risk of developing tuberculosis and invasive fungal infections. A risk evaluation mitigation strategy (REMS) and medication guide are required for this agent.
• Iloperidone (Fanapt), an atypical antipsychotic, has been FDA-approved to treat adults with schizophrenia. The most common side effects in clinical trials were dizziness, dry mouth, fatigue, nasal congestion, and orthostatic hypotension. Similar to other atypical antipsychotics, iloperidone carries a boxed warning regarding increased risk of death associated with treating behavioral problems in older patients with dementia-related psychosis, as it is not FDA-approved for this use.13

 

New Warnings

• Topical testosterone products (e.g., Androgel and Testim) have received a boxed warning.14 This warning is due to multiple reports of adverse effects in children exposed to the drug via contact with a topical testosterone-treated person. There are current product label precautions; however, the FDA has received reports of secondary exposure to testosterone in children 5 years old or younger. Adverse events included inappropriate genitalia enlargement, premature pubic hair development, bone age advancement, increased libido, and aggressive behavior. The FDA has provided recommendations to minimize secondary exposure. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. FDA statement on the voluntary withdrawal of Raptiva from the U.S. market. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149561.htm Accessed July 2, 2009.
2. Withdrawal of Raptiva from U.S. market. The Medical News Web site. Available at: www.news-medical.net/news/48133.aspx. Accessed May 12, 2009.
3. Taro receives final FDA approval for carbamazepine extended-release tablets. Medicine News Today Web site. Available at: www.medicalnewstoday.com/articles/145217.php. Accessed May 12, 2009.
4. FDA OKs Mylan generic version of transplant drug. Forbes Web site. Available at: www.forbes.com/feeds/ap/2009/05/07/ap6392275.html. Accessed May 8, 2009.
5. Exocrine Pancreatic Insufficiency Drug Products. Federal Register Web site. Available at: www.fda.gov/ohrms/dockets/98fr/04-9652.htm. Accessed May 7, 2009.
6. Guidance for industry exocrine pancreatic insufficiency drug products—submitting NDAs. FDA Web site. Available at: www.fda.gov/ohrms/dockets/98fr/2003d-0206-gdl0001.pdf. Accessed May 7, 2009.
7. Phend C. FDA formally approves Creon pancrelipase. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14021. Accessed May 7, 2009.
8. FDA approves Exforge HCT—the only high blood pressure treatment to combine three medications in a single pill. Novartis Web site. Available at: www.novartis.com/newsroom/media-releases/en/2009/1310474.shtml. Accessed May 7, 2009.
9. Phend C. FDA approves triple-drug antihypertensive polypill. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14032. Accessed May 7, 2009.
10. Neergaard L. FDA backs drug that treats diabetes via the brain. Physorg.com Web site. Available at: www.physorg.com/news160843146.html. Last Accessed May 8, 2009.
11. FDA approves Cycloset. Drugs.com Web site. Available at: www.drugs.com/newdrugs/veroscience-announces-fda-approval-cycloset-type-2-diabetes-1344.html. Accessed May 8, 2009.
12. FDA approves monthly injectable drug for treating three types of immune-related arthritis. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149569.htm. Accessed April 24, 2009.
13. FDA approves Fanapt to treat schizophrenia. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149578.htm. Accessed May 7, 2009.
14. Testosterone gel safety concerns prompt FDA to require label changes, medication guide. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm. Accessed May 12, 2009.

Product Withdrawal

• Efalizumab (Raptiva), the once-weekly monoclonal antibody used to treat moderate to severe plaque psoriasis, has been withdrawn from the U.S. market due to its association with an increased risk of developing progressive multifocal leukoencephalopathy (PML).1 Four cases of PML have been confirmed, and the manufacturer has decided the risks outweigh the benefits.2

New Generics

• Carbamazepine extended-release (generic Tegretol-XR) tablets (100 mg, 200 mg and 400 mg)3
• Mycophenolate mofetil (generic Cellcept)4

New Drugs, Indications & Dosage Forms

• You might have noticed some difficulty getting pancrelipase products for your patients with exocrine pancreatic insufficiency (EPI), pancreatitis, or cystic fibrosis. Here’s why: Pancreatic enzyme replacement therapies (PERT), pancreatic enzyme products (PEP), pancrelipase products, or EPI products were available prior to the formation of the U.S. Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA) of 1938.
  

  
  

  Until recently, none of these drug products had been marketed under approved new drug applications (NDAs). Since none of the products were subject to the NDA process, they were never subjected to safety, efficacy, bioavailability, or dose-ranging studies.5 The FDA has since decided that these agents must undergo the NDA process and, if approved, will only be available with a prescription.6
  

  
  

  Part of the guidance states that all approved formulations will contain “zero overfill.” In other words, the products will not have a range of lipase (90% to 165%), as they had before. Overfill leads to side effects, including diarrhea, flatulence, hyperuricosuria, hyperuricosemia, and fibrosing colonopathy.
  

  
  

  The new deadline to submit an NDA is April 29, 2010. The FDA has approved its first PEP agent, Creon pancrelipase, under the new guidance. It is expected to be available later this year.7

• Amlodipine, hydrochlorothiazide (HCTZ), and valsartan (Exforge HCT) is the first—and currently only—triple-combination antihypertensive agent to receive FDA approval.8 It can be used in patients already on these three medications, or it can be used as add-on therapy in patients not adequately controlled on two agents. The manufacturer plans to price the agent the same as amlodipine/valsartan (Exforge). Dose options are amlodipine 5 mg/valsartan 160 mg/HCTZ 12.5 mg, up to a maximum of two tablets daily.9
• Bromocriptine (Cycloset) is reformulated in a lower dose that is fast-acting and should be taken in the morning to boost dopamine levels and improve glycemic control in Type 2 diabetes patients.10 The drug is approved for monotherapy, as an adjunct to sulfonylurea therapy, or metformin plus a sulfonylurea. It’s the first diabetes agent to be FDA-approved since the guidance on cardiovascular risks. The most common side effects in clinical trials were nausea and dizziness. It should be used cautiously in patients taking antihypertensive treatment. Women who are nursing should not use it. The launch date is unknown.11
• Golimumab (Simponi), a once-a-month tumor necrosis factor-alpha inhibitor injection, has been FDA-approved for treating moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.12 It carries the same warnings as other agents in the same class, including the risk of developing tuberculosis and invasive fungal infections. A risk evaluation mitigation strategy (REMS) and medication guide are required for this agent.
• Iloperidone (Fanapt), an atypical antipsychotic, has been FDA-approved to treat adults with schizophrenia. The most common side effects in clinical trials were dizziness, dry mouth, fatigue, nasal congestion, and orthostatic hypotension. Similar to other atypical antipsychotics, iloperidone carries a boxed warning regarding increased risk of death associated with treating behavioral problems in older patients with dementia-related psychosis, as it is not FDA-approved for this use.13

 

New Warnings

• Topical testosterone products (e.g., Androgel and Testim) have received a boxed warning.14 This warning is due to multiple reports of adverse effects in children exposed to the drug via contact with a topical testosterone-treated person. There are current product label precautions; however, the FDA has received reports of secondary exposure to testosterone in children 5 years old or younger. Adverse events included inappropriate genitalia enlargement, premature pubic hair development, bone age advancement, increased libido, and aggressive behavior. The FDA has provided recommendations to minimize secondary exposure. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. FDA statement on the voluntary withdrawal of Raptiva from the U.S. market. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149561.htm Accessed July 2, 2009.
2. Withdrawal of Raptiva from U.S. market. The Medical News Web site. Available at: www.news-medical.net/news/48133.aspx. Accessed May 12, 2009.
3. Taro receives final FDA approval for carbamazepine extended-release tablets. Medicine News Today Web site. Available at: www.medicalnewstoday.com/articles/145217.php. Accessed May 12, 2009.
4. FDA OKs Mylan generic version of transplant drug. Forbes Web site. Available at: www.forbes.com/feeds/ap/2009/05/07/ap6392275.html. Accessed May 8, 2009.
5. Exocrine Pancreatic Insufficiency Drug Products. Federal Register Web site. Available at: www.fda.gov/ohrms/dockets/98fr/04-9652.htm. Accessed May 7, 2009.
6. Guidance for industry exocrine pancreatic insufficiency drug products—submitting NDAs. FDA Web site. Available at: www.fda.gov/ohrms/dockets/98fr/2003d-0206-gdl0001.pdf. Accessed May 7, 2009.
7. Phend C. FDA formally approves Creon pancrelipase. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14021. Accessed May 7, 2009.
8. FDA approves Exforge HCT—the only high blood pressure treatment to combine three medications in a single pill. Novartis Web site. Available at: www.novartis.com/newsroom/media-releases/en/2009/1310474.shtml. Accessed May 7, 2009.
9. Phend C. FDA approves triple-drug antihypertensive polypill. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14032. Accessed May 7, 2009.
10. Neergaard L. FDA backs drug that treats diabetes via the brain. Physorg.com Web site. Available at: www.physorg.com/news160843146.html. Last Accessed May 8, 2009.
11. FDA approves Cycloset. Drugs.com Web site. Available at: www.drugs.com/newdrugs/veroscience-announces-fda-approval-cycloset-type-2-diabetes-1344.html. Accessed May 8, 2009.
12. FDA approves monthly injectable drug for treating three types of immune-related arthritis. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149569.htm. Accessed April 24, 2009.
13. FDA approves Fanapt to treat schizophrenia. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149578.htm. Accessed May 7, 2009.
14. Testosterone gel safety concerns prompt FDA to require label changes, medication guide. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm. Accessed May 12, 2009.

Product Withdrawal

• Efalizumab (Raptiva), the once-weekly monoclonal antibody used to treat moderate to severe plaque psoriasis, has been withdrawn from the U.S. market due to its association with an increased risk of developing progressive multifocal leukoencephalopathy (PML).1 Four cases of PML have been confirmed, and the manufacturer has decided the risks outweigh the benefits.2

New Generics

• Carbamazepine extended-release (generic Tegretol-XR) tablets (100 mg, 200 mg and 400 mg)3
• Mycophenolate mofetil (generic Cellcept)4

New Drugs, Indications & Dosage Forms

• You might have noticed some difficulty getting pancrelipase products for your patients with exocrine pancreatic insufficiency (EPI), pancreatitis, or cystic fibrosis. Here’s why: Pancreatic enzyme replacement therapies (PERT), pancreatic enzyme products (PEP), pancrelipase products, or EPI products were available prior to the formation of the U.S. Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA) of 1938.
  

  
  

  Until recently, none of these drug products had been marketed under approved new drug applications (NDAs). Since none of the products were subject to the NDA process, they were never subjected to safety, efficacy, bioavailability, or dose-ranging studies.5 The FDA has since decided that these agents must undergo the NDA process and, if approved, will only be available with a prescription.6
  

  
  

  Part of the guidance states that all approved formulations will contain “zero overfill.” In other words, the products will not have a range of lipase (90% to 165%), as they had before. Overfill leads to side effects, including diarrhea, flatulence, hyperuricosuria, hyperuricosemia, and fibrosing colonopathy.
  

  
  

  The new deadline to submit an NDA is April 29, 2010. The FDA has approved its first PEP agent, Creon pancrelipase, under the new guidance. It is expected to be available later this year.7

• Amlodipine, hydrochlorothiazide (HCTZ), and valsartan (Exforge HCT) is the first—and currently only—triple-combination antihypertensive agent to receive FDA approval.8 It can be used in patients already on these three medications, or it can be used as add-on therapy in patients not adequately controlled on two agents. The manufacturer plans to price the agent the same as amlodipine/valsartan (Exforge). Dose options are amlodipine 5 mg/valsartan 160 mg/HCTZ 12.5 mg, up to a maximum of two tablets daily.9
• Bromocriptine (Cycloset) is reformulated in a lower dose that is fast-acting and should be taken in the morning to boost dopamine levels and improve glycemic control in Type 2 diabetes patients.10 The drug is approved for monotherapy, as an adjunct to sulfonylurea therapy, or metformin plus a sulfonylurea. It’s the first diabetes agent to be FDA-approved since the guidance on cardiovascular risks. The most common side effects in clinical trials were nausea and dizziness. It should be used cautiously in patients taking antihypertensive treatment. Women who are nursing should not use it. The launch date is unknown.11
• Golimumab (Simponi), a once-a-month tumor necrosis factor-alpha inhibitor injection, has been FDA-approved for treating moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.12 It carries the same warnings as other agents in the same class, including the risk of developing tuberculosis and invasive fungal infections. A risk evaluation mitigation strategy (REMS) and medication guide are required for this agent.
• Iloperidone (Fanapt), an atypical antipsychotic, has been FDA-approved to treat adults with schizophrenia. The most common side effects in clinical trials were dizziness, dry mouth, fatigue, nasal congestion, and orthostatic hypotension. Similar to other atypical antipsychotics, iloperidone carries a boxed warning regarding increased risk of death associated with treating behavioral problems in older patients with dementia-related psychosis, as it is not FDA-approved for this use.13

 

New Warnings

• Topical testosterone products (e.g., Androgel and Testim) have received a boxed warning.14 This warning is due to multiple reports of adverse effects in children exposed to the drug via contact with a topical testosterone-treated person. There are current product label precautions; however, the FDA has received reports of secondary exposure to testosterone in children 5 years old or younger. Adverse events included inappropriate genitalia enlargement, premature pubic hair development, bone age advancement, increased libido, and aggressive behavior. The FDA has provided recommendations to minimize secondary exposure. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. FDA statement on the voluntary withdrawal of Raptiva from the U.S. market. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149561.htm Accessed July 2, 2009.
2. Withdrawal of Raptiva from U.S. market. The Medical News Web site. Available at: www.news-medical.net/news/48133.aspx. Accessed May 12, 2009.
3. Taro receives final FDA approval for carbamazepine extended-release tablets. Medicine News Today Web site. Available at: www.medicalnewstoday.com/articles/145217.php. Accessed May 12, 2009.
4. FDA OKs Mylan generic version of transplant drug. Forbes Web site. Available at: www.forbes.com/feeds/ap/2009/05/07/ap6392275.html. Accessed May 8, 2009.
5. Exocrine Pancreatic Insufficiency Drug Products. Federal Register Web site. Available at: www.fda.gov/ohrms/dockets/98fr/04-9652.htm. Accessed May 7, 2009.
6. Guidance for industry exocrine pancreatic insufficiency drug products—submitting NDAs. FDA Web site. Available at: www.fda.gov/ohrms/dockets/98fr/2003d-0206-gdl0001.pdf. Accessed May 7, 2009.
7. Phend C. FDA formally approves Creon pancrelipase. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14021. Accessed May 7, 2009.
8. FDA approves Exforge HCT—the only high blood pressure treatment to combine three medications in a single pill. Novartis Web site. Available at: www.novartis.com/newsroom/media-releases/en/2009/1310474.shtml. Accessed May 7, 2009.
9. Phend C. FDA approves triple-drug antihypertensive polypill. Medpage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/14032. Accessed May 7, 2009.
10. Neergaard L. FDA backs drug that treats diabetes via the brain. Physorg.com Web site. Available at: www.physorg.com/news160843146.html. Last Accessed May 8, 2009.
11. FDA approves Cycloset. Drugs.com Web site. Available at: www.drugs.com/newdrugs/veroscience-announces-fda-approval-cycloset-type-2-diabetes-1344.html. Accessed May 8, 2009.
12. FDA approves monthly injectable drug for treating three types of immune-related arthritis. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149569.htm. Accessed April 24, 2009.
13. FDA approves Fanapt to treat schizophrenia. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149578.htm. Accessed May 7, 2009.
14. Testosterone gel safety concerns prompt FDA to require label changes, medication guide. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm. Accessed May 12, 2009.

In This Edition

Literature at a Glance

A guide to this month’s studies

• PE and COPD exacerbations.
• Care bundles and readmission rates.
• Family history and VTE risk.
• Vasopressor choice and mortality in sepsis.
• Vitamin K use in overanticoagulation.
• Appropriate treatment of asymptomatic bacteriuria.
• Guideline adherence in thrombocytopenia.

Pulmonary Embolism Frequently Complicates COPD Exacerbations

 

Clinical question: What percentage of patients with acute chronic obstructive pulmonary disease (COPD) exacerbations has pulmonary emboli?

Background: As many as 30% of COPD exacerbations have no apparent precipitating event. Even in patients with evidence of a precipitating event, such as an upper-respiratory illness or increased environmental irritants, pulmonary emboli (PE) may coexist and warrant evaluation.

Study design: Literature review.

Setting: Multiple studies in Europe and the U.S.

Synopsis: This literature review included five studies to estimate the rate of PE in patients with a COPD exacerbation. Overall incidence of PE in COPD exacerbations was 19.9%, but of those patients requiring hospitalization, the incidence was as high as 25.5%. Incidence estimates varied based on interpretation of data that were missing or inconsistent between studies. Patients most commonly present with dyspnea, chest pain, hemoptysis, cough, and palpitations. Six percent of PE patients presented with syncope; no patients with an exacerbation without a PE presented with syncope.

Risk of mortality from PE is almost twice as high in patients with a COPD exacerbation compared with PE in other settings. A significant number of patients have PE without history or evidence of DVT, so in situ thrombosis is a significant factor. The interpretation of these results is limited by the heterogeneity of the study designs, and by the relatively low number of cases. Larger trials are necessary.

Bottom line: Pulmonary emboli are present in as many as 25% of all COPD exacerbations. Delay in diagnosis of PE in COPD patients affects morbidity and mortality. PE should be a consideration in many COPD exacerbations.

Citation: Rizkallah J, Man SF, Din DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009;135(3):786-793.

Targeted-Care Bundle Can Reduce ED Visits and Readmission Rates in High-Risk Elderly Patients

Clinical question: Can a care coordination bundle reduce length of stay (LOS), ED visits, or readmissions within 30 days of a hospital admission?

Background: Hospital-based care coordination interventions have shown mixed results in affecting LOS, post-discharge ED visits, and readmission rates. Although there has been some success with particular interventions, no consistent benefit has been demonstrated. Most notably, a recent meta-analysis of several different interventions showed no improvement in mortality, LOS, or readmission rates.

Study design: A randomized, controlled trial of select high-risk elderly patients.

Setting: A large teaching hospital at Baylor University Medical Center.

Synopsis: A “targeted-care bundle” was implemented with high-risk elderly patients to try to reduce LOS, readmissions, and ED visits. High-risk patients were identified by age, diagnosis-related group (DRG), number of medications at admission, comorbid conditions, and need for assistance in activities of daily living. Subjects were randomized to usual care or to receive a targeted-care bundle. The targeted-care bundle included multiple interventions. A study care coordinator provided daily patient education, including condition-specific teaching, discharge teaching and planning, and a follow-up phone call at five to seven days after discharge. A clinical pharmacist intervened for medication reconciliation at admission and discharge, medication teaching, and a follow-up phone call at five to seven days after discharge. Structured documents, including a personal health record and supplemental discharge form, were implemented.

The study had low enrollment, largely due to the requirement to obtain informed consent from all participants. Therefore, the study was underpowered to detect such target endpoints as LOS. A significant decrease in 30-day readmission rates/ED visits was noticed, but there was no persistent effect at 60 days.

The intervention was designed to use existing hospital staff in order to be practical for broad utilization. Future studies need to focus on increased enrollment to demonstrate beneficial effect.

 

Bottom line: Targeted health interventions focusing on education and coordination of care might effect some significant outcomes, most notably readmissions or ED visits within 30 days, but the nature of the clinical problem makes rigorous testing of interventions a challenge.

Citation: Kohler BE, Richter KM, Youngblood L, et al. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-218.

Family History Is a Risk Factor for Venous Thrombosis

Clinical question: Is family history of additional value in predicting an individual’s risk of venous thrombosis once a genetic risk factor is identified?

Background: A positive family history of venous thrombosis might suggest the presence of genetic risk factors in a given family. However, it is not known whether family history is of additional significance—once a risk factor is identified—in predicting an individual’s risk for venous thrombosis.

Study design: Population-based, case-control study.

Setting: Participants in the Multiple Environmental and Genetic Assessment (MEGA) of risk factors for venous thrombosis study.

Synopsis: Recruitment, data collection, and blood samples were obtained from individuals in the MEGA study. Participants completed a questionnaire about risk factors for venous thrombosis and family history. A positive family history more than doubled the risk of venous thrombosis, and when more than one family member was affected, the risk increased fourfold. The risk for venous thrombosis increased 64 times for individuals who had a family history, genetic risk factor, and environmental risk factor when compared with those with a negative family history and no known risk factors.

The underreporting or overestimation of the prevalence of a positive family history might limit this study.

Bottom line: Family history is a risk indictor for a first venous thrombosis, despite the presence of other risk factors.

Citation: Bezemer ID, van der Meer FJ, Eikenboom JC, Rosendaal FR, Doggen CJ. The value of family history as a risk indicator for venous thrombosis. Arch Intern Med. 2009;169(6):610-615.

Vasopressor Choice Predicts Mortality in Septic Shock

Clinical question: Does vasopressor choice affect mortality in patients with community-acquired septic shock?

Background: Community-acquired septic shock is a common illness and, despite aggressive care, a leading cause of death. Randomized clinical control trials evaluating the efficacy and safety of different adrenergic supportive agents are lacking. Thus, both norepinephrine and dopamine are recommended as first-line agents in the treatment of septic shock by the Surviving Sepsis Campaign guidelines.

Study design: Multicenter, cohort observational study.

Setting: Seventeen intensive-care units in Portugal.

Synopsis: In adjusted analysis controlling for Simplified Acute Physiology Score (SAPS) II, use of norepinephrine in community-acquired septic shock was associated with higher hospital mortality and lower 28-day survival when compared with dopamine. Specifically, patients treated with norepinephrine had a statistically significant higher hospital mortality rate than those treated with dopamine (52% and 38.5%, respectively, P=0.002) and a lower 28-day survival (log rank=22.6; P<0.001). While this data is valuable, the nonrandomized, observational study design limits firm conclusions regarding vasopressor choice. Further results from three large trials comparing vasopressor use in septic shock should continue to shed light on this debate.

Bottom line: Norepinephrine administration is associated with higher hospital mortality and lower 28-day survival when compared with dopamine in patients with community-acquired septic shock.

Citation: Póvoa PR, Carneiro AH, Ribeiro OS, Pereira AC, Portuguese Community-Acquired Sepsis Study Group. Influence of vasopressor agent in septic shock mortality. Results from the Portuguese Community-Acquired Sepsis Study (SACiUCI study). Crit Care Med. 2009;37(2):410-416.

 

Oral Vitamin K Versus Placebo to Correct Excess Anticoagulation in Warfarin Patients

Clinical question: In nonbleeding patients with warfarin-associated coagulopathy, does oral vitamin K reduce bleeding events when compared to placebo?

Background: Warfarin is a common drug for primary and secondary prevention of thromboembolism, but it requires continued monitoring of the international normalized ratio (INR) value. INR values >4.0 are associated with an increase in bleeding complications, with specific concern for intracranial bleeding when INR values exceed 4.5. Small, randomized trials have shown that single, low-dose administration of oral vitamin K effectively reduces the INR in nonbleeding, overanticoagulated patients.

However, these studies have not shown if vitamin K reduces risk for bleeding without increasing the risk for thromboembolism.

Study design: Randomized, placebo-controlled trial.

Setting: Fourteen anticoagulation clinics in Canada, Italy, and the U.S.

Synopsis: Nonbleeding patients with supratherapeutic INR values between 4.5 and 10.0 were randomly assigned to receive 1.25 mg of oral vitamin K or placebo, then evaluated for all forms of bleeding for 90 days. Bleeding events were defined as “major bleeding,” “minor bleeding,” and “trivial bleeding.”

Though patients who received oral vitamin K had a significantly more rapid INR decrease, there were no differences between the two groups with regard to all bleeding events, thromboembolism, or death. The study was underpowered to detect differences in major bleeding.

Bottom line: Low-dose oral vitamin K leads to more rapid correction of the INR in overanticoagulated patients on warfarin therapy, but has little effect on clinical outcomes at 90 days.

Citation: Crowther MA, Ageno W, Garcia D, et al. Oral vitamin K versus placebo to correct excessive anticoagulation in patients receiving warfarin: a randomized trial. Ann Intern Med. 2009;150(5):293-300.

Inappropriate Treatment of Catheter-Associated Asymptomatic Bacteriuria

Clinical question: Are hospitalized patients with urinary catheters inappropriately treated with antibiotics for asymptomatic bacteriuria?

Background: Persons with catheters acquire bacteriuria at the rate of 3% to 10% per day, but in the majority of cases, no symptoms or secondary complications occur. Evidenced-based guidelines state that asymptomatic bacteriuria is not a clinically significant infection, and numerous studies have shown that treatment is unlikely to confer clinical benefit.

Study design: Retrospective cohort study.

Setting: A single-site Veterans Affairs hospital.

Synopsis: Using urine culture results over a three-month period from a single VA medical center, 280 cases were analyzed: 164 catheter-associated asymptomatic bacteriuria and 116 catheter-associated urinary tract infections (UTIs). A UTI was defined as having one or more of these symptoms: fever, urgency, frequency, dysuria, suprapubic tenderness, altered mental status, or hypotension in a patient without another recognized infection and a positive urine culture. Of the asymptomatic bacteriuria cases, 68% were managed appropriately with no antibiotic treatment; 32% were inappropriately treated with antibiotics.

In multivariate analysis, older patient age, predominance of gram-negative bacteria, and higher urine white blood cell count were significantly associated with inappropriate treatment.

This study highlights the fact that antibiotics continue to be used inappropriately in patients with catheters. Current guidelines do not distinguish well between asymptomatic bacteriuria and UTI, so there might be a knowledge gap. This study was based on urine culture data, not urinalysis of all patients with a catheter, so the symptomatic patients were likely over-represented.

An associated editorial observes that the study extrapolates data from studies that involved patients with uncomplicated UTIs and, therefore, might reach erroneous conclusions. Further, viewing catheter-associated symptomatic UTIs and catheter-associated asymptomatic bactiuria as dichotomous and warranting inherently different management fails to encompass a number of clinical factors, including co-infection, and further fails to acknowledge that removal of the catheter is the first step in treatment. However, the finding that antibiotics continue to be used inappropriately is useful.

 

Bottom line: A clinical determination of whether a patient with a catheter really has a symptomatic UTI/urosepsis or only has asymptomatic bacteriuria should precede starting antibiotics in hospitalized patients.

Citations: Cope M, Cevallos ME, Cadle RM, Darouiche RO, Musher DM, Trautner BW. Inappropriate treatment of catheter-associated asymptomatic bateriuria in a tertiary care hospital. Clin Infect Dis. 2009;48(9):1182-1188.

Kunin CM. Catheter-associated urinary tract infections: a syllogism compounded by a questionable dichotomy. Clin Infect Dis. 2009;48:1189-1190.

Current Practices in the Evaluation and Management of Thrombocytopenia in Heparin Patients

Clinical question: Are the current American College of Chest Physicians (ACCP) guidelines for the recognition, treatment, and prevention of heparin-induced thrombocytopenia (HIT) being followed?

Background: Heparin-based anticoagulation is frequently given to hospitalized patients, and approximately 1% to 5% of these patients develop HIT. In 2004, the ACCP published a consensus statement on the evaluation, management, and prevention of HIT.

Study design: Prospective, observational study.

Setting: Forty-eight U.S. hospitals in the Complications After Thrombocytopenia Caused by Heparin (CATCH) registry.

Synopsis: The CATCH trial enrolled patients receiving any form of heparin for >96 hours (n=2,420), cardiac-care-unit patients treated with heparin (n=1,090), and patients who had an HIT antibody assay performed (n=449), for a total of 3,536 total patients. The study included patients on unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Thrombocytopenia was defined at a platelet count <150,000, or a decrease of 50% when compared with admission.

In the prolonged heparin group, 36.4% of patients developed thrombocytopenia; however, HIT was suspected in only 19.8% of these high-risk patients. While physicians were more likely to consider HIT in the cardiac-care patients (37.6%), the diagnosis was considered>24 hours after the thrombocytopenia developed. Physicians often waited until after a thromboembolic complication occurred before evaluating for HIT. More often than not, preventive measures were missed (e.g., failing to check for HIT antibodies, continuing heparin after HIT was suspected).

Bottom line: Thrombocytopenia is a common occurrence in patients receiving heparin and, despite the risk of devastating complications from HIT, treatment infrequently conforms to the established guidelines.

Citation: Crespo EM, Oliveira GBF, Honeycutt EF, et al. Evaluation and management of thrombocytopenia and suspected heparin-induced thrombocytopenia in hospitalized patients: The Complications After Thrombocytopenia Caused by Heparin (CATCH) registry. Am Heart J. 2009;157(4):651-657. TH

In This Edition

Literature at a Glance

A guide to this month’s studies

• PE and COPD exacerbations.
• Care bundles and readmission rates.
• Family history and VTE risk.
• Vasopressor choice and mortality in sepsis.
• Vitamin K use in overanticoagulation.
• Appropriate treatment of asymptomatic bacteriuria.
• Guideline adherence in thrombocytopenia.

Pulmonary Embolism Frequently Complicates COPD Exacerbations

 

Clinical question: What percentage of patients with acute chronic obstructive pulmonary disease (COPD) exacerbations has pulmonary emboli?

Background: As many as 30% of COPD exacerbations have no apparent precipitating event. Even in patients with evidence of a precipitating event, such as an upper-respiratory illness or increased environmental irritants, pulmonary emboli (PE) may coexist and warrant evaluation.

Study design: Literature review.

Setting: Multiple studies in Europe and the U.S.

Synopsis: This literature review included five studies to estimate the rate of PE in patients with a COPD exacerbation. Overall incidence of PE in COPD exacerbations was 19.9%, but of those patients requiring hospitalization, the incidence was as high as 25.5%. Incidence estimates varied based on interpretation of data that were missing or inconsistent between studies. Patients most commonly present with dyspnea, chest pain, hemoptysis, cough, and palpitations. Six percent of PE patients presented with syncope; no patients with an exacerbation without a PE presented with syncope.

Risk of mortality from PE is almost twice as high in patients with a COPD exacerbation compared with PE in other settings. A significant number of patients have PE without history or evidence of DVT, so in situ thrombosis is a significant factor. The interpretation of these results is limited by the heterogeneity of the study designs, and by the relatively low number of cases. Larger trials are necessary.

Bottom line: Pulmonary emboli are present in as many as 25% of all COPD exacerbations. Delay in diagnosis of PE in COPD patients affects morbidity and mortality. PE should be a consideration in many COPD exacerbations.

Citation: Rizkallah J, Man SF, Din DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009;135(3):786-793.

Targeted-Care Bundle Can Reduce ED Visits and Readmission Rates in High-Risk Elderly Patients

Clinical question: Can a care coordination bundle reduce length of stay (LOS), ED visits, or readmissions within 30 days of a hospital admission?

Background: Hospital-based care coordination interventions have shown mixed results in affecting LOS, post-discharge ED visits, and readmission rates. Although there has been some success with particular interventions, no consistent benefit has been demonstrated. Most notably, a recent meta-analysis of several different interventions showed no improvement in mortality, LOS, or readmission rates.

Study design: A randomized, controlled trial of select high-risk elderly patients.

Setting: A large teaching hospital at Baylor University Medical Center.

Synopsis: A “targeted-care bundle” was implemented with high-risk elderly patients to try to reduce LOS, readmissions, and ED visits. High-risk patients were identified by age, diagnosis-related group (DRG), number of medications at admission, comorbid conditions, and need for assistance in activities of daily living. Subjects were randomized to usual care or to receive a targeted-care bundle. The targeted-care bundle included multiple interventions. A study care coordinator provided daily patient education, including condition-specific teaching, discharge teaching and planning, and a follow-up phone call at five to seven days after discharge. A clinical pharmacist intervened for medication reconciliation at admission and discharge, medication teaching, and a follow-up phone call at five to seven days after discharge. Structured documents, including a personal health record and supplemental discharge form, were implemented.

The study had low enrollment, largely due to the requirement to obtain informed consent from all participants. Therefore, the study was underpowered to detect such target endpoints as LOS. A significant decrease in 30-day readmission rates/ED visits was noticed, but there was no persistent effect at 60 days.

The intervention was designed to use existing hospital staff in order to be practical for broad utilization. Future studies need to focus on increased enrollment to demonstrate beneficial effect.

 

Bottom line: Targeted health interventions focusing on education and coordination of care might effect some significant outcomes, most notably readmissions or ED visits within 30 days, but the nature of the clinical problem makes rigorous testing of interventions a challenge.

Citation: Kohler BE, Richter KM, Youngblood L, et al. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-218.

Family History Is a Risk Factor for Venous Thrombosis

Clinical question: Is family history of additional value in predicting an individual’s risk of venous thrombosis once a genetic risk factor is identified?

Background: A positive family history of venous thrombosis might suggest the presence of genetic risk factors in a given family. However, it is not known whether family history is of additional significance—once a risk factor is identified—in predicting an individual’s risk for venous thrombosis.

Study design: Population-based, case-control study.

Setting: Participants in the Multiple Environmental and Genetic Assessment (MEGA) of risk factors for venous thrombosis study.

Synopsis: Recruitment, data collection, and blood samples were obtained from individuals in the MEGA study. Participants completed a questionnaire about risk factors for venous thrombosis and family history. A positive family history more than doubled the risk of venous thrombosis, and when more than one family member was affected, the risk increased fourfold. The risk for venous thrombosis increased 64 times for individuals who had a family history, genetic risk factor, and environmental risk factor when compared with those with a negative family history and no known risk factors.

The underreporting or overestimation of the prevalence of a positive family history might limit this study.

Bottom line: Family history is a risk indictor for a first venous thrombosis, despite the presence of other risk factors.

Citation: Bezemer ID, van der Meer FJ, Eikenboom JC, Rosendaal FR, Doggen CJ. The value of family history as a risk indicator for venous thrombosis. Arch Intern Med. 2009;169(6):610-615.

Vasopressor Choice Predicts Mortality in Septic Shock

Clinical question: Does vasopressor choice affect mortality in patients with community-acquired septic shock?

Background: Community-acquired septic shock is a common illness and, despite aggressive care, a leading cause of death. Randomized clinical control trials evaluating the efficacy and safety of different adrenergic supportive agents are lacking. Thus, both norepinephrine and dopamine are recommended as first-line agents in the treatment of septic shock by the Surviving Sepsis Campaign guidelines.

Study design: Multicenter, cohort observational study.

Setting: Seventeen intensive-care units in Portugal.

Synopsis: In adjusted analysis controlling for Simplified Acute Physiology Score (SAPS) II, use of norepinephrine in community-acquired septic shock was associated with higher hospital mortality and lower 28-day survival when compared with dopamine. Specifically, patients treated with norepinephrine had a statistically significant higher hospital mortality rate than those treated with dopamine (52% and 38.5%, respectively, P=0.002) and a lower 28-day survival (log rank=22.6; P<0.001). While this data is valuable, the nonrandomized, observational study design limits firm conclusions regarding vasopressor choice. Further results from three large trials comparing vasopressor use in septic shock should continue to shed light on this debate.

Bottom line: Norepinephrine administration is associated with higher hospital mortality and lower 28-day survival when compared with dopamine in patients with community-acquired septic shock.

Citation: Póvoa PR, Carneiro AH, Ribeiro OS, Pereira AC, Portuguese Community-Acquired Sepsis Study Group. Influence of vasopressor agent in septic shock mortality. Results from the Portuguese Community-Acquired Sepsis Study (SACiUCI study). Crit Care Med. 2009;37(2):410-416.

 

Oral Vitamin K Versus Placebo to Correct Excess Anticoagulation in Warfarin Patients

Clinical question: In nonbleeding patients with warfarin-associated coagulopathy, does oral vitamin K reduce bleeding events when compared to placebo?

Background: Warfarin is a common drug for primary and secondary prevention of thromboembolism, but it requires continued monitoring of the international normalized ratio (INR) value. INR values >4.0 are associated with an increase in bleeding complications, with specific concern for intracranial bleeding when INR values exceed 4.5. Small, randomized trials have shown that single, low-dose administration of oral vitamin K effectively reduces the INR in nonbleeding, overanticoagulated patients.

However, these studies have not shown if vitamin K reduces risk for bleeding without increasing the risk for thromboembolism.

Study design: Randomized, placebo-controlled trial.

Setting: Fourteen anticoagulation clinics in Canada, Italy, and the U.S.

Synopsis: Nonbleeding patients with supratherapeutic INR values between 4.5 and 10.0 were randomly assigned to receive 1.25 mg of oral vitamin K or placebo, then evaluated for all forms of bleeding for 90 days. Bleeding events were defined as “major bleeding,” “minor bleeding,” and “trivial bleeding.”

Though patients who received oral vitamin K had a significantly more rapid INR decrease, there were no differences between the two groups with regard to all bleeding events, thromboembolism, or death. The study was underpowered to detect differences in major bleeding.

Bottom line: Low-dose oral vitamin K leads to more rapid correction of the INR in overanticoagulated patients on warfarin therapy, but has little effect on clinical outcomes at 90 days.

Citation: Crowther MA, Ageno W, Garcia D, et al. Oral vitamin K versus placebo to correct excessive anticoagulation in patients receiving warfarin: a randomized trial. Ann Intern Med. 2009;150(5):293-300.

Inappropriate Treatment of Catheter-Associated Asymptomatic Bacteriuria

Clinical question: Are hospitalized patients with urinary catheters inappropriately treated with antibiotics for asymptomatic bacteriuria?

Background: Persons with catheters acquire bacteriuria at the rate of 3% to 10% per day, but in the majority of cases, no symptoms or secondary complications occur. Evidenced-based guidelines state that asymptomatic bacteriuria is not a clinically significant infection, and numerous studies have shown that treatment is unlikely to confer clinical benefit.

Study design: Retrospective cohort study.

Setting: A single-site Veterans Affairs hospital.

Synopsis: Using urine culture results over a three-month period from a single VA medical center, 280 cases were analyzed: 164 catheter-associated asymptomatic bacteriuria and 116 catheter-associated urinary tract infections (UTIs). A UTI was defined as having one or more of these symptoms: fever, urgency, frequency, dysuria, suprapubic tenderness, altered mental status, or hypotension in a patient without another recognized infection and a positive urine culture. Of the asymptomatic bacteriuria cases, 68% were managed appropriately with no antibiotic treatment; 32% were inappropriately treated with antibiotics.

In multivariate analysis, older patient age, predominance of gram-negative bacteria, and higher urine white blood cell count were significantly associated with inappropriate treatment.

This study highlights the fact that antibiotics continue to be used inappropriately in patients with catheters. Current guidelines do not distinguish well between asymptomatic bacteriuria and UTI, so there might be a knowledge gap. This study was based on urine culture data, not urinalysis of all patients with a catheter, so the symptomatic patients were likely over-represented.

An associated editorial observes that the study extrapolates data from studies that involved patients with uncomplicated UTIs and, therefore, might reach erroneous conclusions. Further, viewing catheter-associated symptomatic UTIs and catheter-associated asymptomatic bactiuria as dichotomous and warranting inherently different management fails to encompass a number of clinical factors, including co-infection, and further fails to acknowledge that removal of the catheter is the first step in treatment. However, the finding that antibiotics continue to be used inappropriately is useful.

 

Bottom line: A clinical determination of whether a patient with a catheter really has a symptomatic UTI/urosepsis or only has asymptomatic bacteriuria should precede starting antibiotics in hospitalized patients.

Citations: Cope M, Cevallos ME, Cadle RM, Darouiche RO, Musher DM, Trautner BW. Inappropriate treatment of catheter-associated asymptomatic bateriuria in a tertiary care hospital. Clin Infect Dis. 2009;48(9):1182-1188.

Kunin CM. Catheter-associated urinary tract infections: a syllogism compounded by a questionable dichotomy. Clin Infect Dis. 2009;48:1189-1190.

Current Practices in the Evaluation and Management of Thrombocytopenia in Heparin Patients

Clinical question: Are the current American College of Chest Physicians (ACCP) guidelines for the recognition, treatment, and prevention of heparin-induced thrombocytopenia (HIT) being followed?

Background: Heparin-based anticoagulation is frequently given to hospitalized patients, and approximately 1% to 5% of these patients develop HIT. In 2004, the ACCP published a consensus statement on the evaluation, management, and prevention of HIT.

Study design: Prospective, observational study.

Setting: Forty-eight U.S. hospitals in the Complications After Thrombocytopenia Caused by Heparin (CATCH) registry.

Synopsis: The CATCH trial enrolled patients receiving any form of heparin for >96 hours (n=2,420), cardiac-care-unit patients treated with heparin (n=1,090), and patients who had an HIT antibody assay performed (n=449), for a total of 3,536 total patients. The study included patients on unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Thrombocytopenia was defined at a platelet count <150,000, or a decrease of 50% when compared with admission.

In the prolonged heparin group, 36.4% of patients developed thrombocytopenia; however, HIT was suspected in only 19.8% of these high-risk patients. While physicians were more likely to consider HIT in the cardiac-care patients (37.6%), the diagnosis was considered>24 hours after the thrombocytopenia developed. Physicians often waited until after a thromboembolic complication occurred before evaluating for HIT. More often than not, preventive measures were missed (e.g., failing to check for HIT antibodies, continuing heparin after HIT was suspected).

Bottom line: Thrombocytopenia is a common occurrence in patients receiving heparin and, despite the risk of devastating complications from HIT, treatment infrequently conforms to the established guidelines.

Citation: Crespo EM, Oliveira GBF, Honeycutt EF, et al. Evaluation and management of thrombocytopenia and suspected heparin-induced thrombocytopenia in hospitalized patients: The Complications After Thrombocytopenia Caused by Heparin (CATCH) registry. Am Heart J. 2009;157(4):651-657. TH

In This Edition

Literature at a Glance

A guide to this month’s studies

• PE and COPD exacerbations.
• Care bundles and readmission rates.
• Family history and VTE risk.
• Vasopressor choice and mortality in sepsis.
• Vitamin K use in overanticoagulation.
• Appropriate treatment of asymptomatic bacteriuria.
• Guideline adherence in thrombocytopenia.

Pulmonary Embolism Frequently Complicates COPD Exacerbations

 

Clinical question: What percentage of patients with acute chronic obstructive pulmonary disease (COPD) exacerbations has pulmonary emboli?

Background: As many as 30% of COPD exacerbations have no apparent precipitating event. Even in patients with evidence of a precipitating event, such as an upper-respiratory illness or increased environmental irritants, pulmonary emboli (PE) may coexist and warrant evaluation.

Study design: Literature review.

Setting: Multiple studies in Europe and the U.S.

Synopsis: This literature review included five studies to estimate the rate of PE in patients with a COPD exacerbation. Overall incidence of PE in COPD exacerbations was 19.9%, but of those patients requiring hospitalization, the incidence was as high as 25.5%. Incidence estimates varied based on interpretation of data that were missing or inconsistent between studies. Patients most commonly present with dyspnea, chest pain, hemoptysis, cough, and palpitations. Six percent of PE patients presented with syncope; no patients with an exacerbation without a PE presented with syncope.

Risk of mortality from PE is almost twice as high in patients with a COPD exacerbation compared with PE in other settings. A significant number of patients have PE without history or evidence of DVT, so in situ thrombosis is a significant factor. The interpretation of these results is limited by the heterogeneity of the study designs, and by the relatively low number of cases. Larger trials are necessary.

Bottom line: Pulmonary emboli are present in as many as 25% of all COPD exacerbations. Delay in diagnosis of PE in COPD patients affects morbidity and mortality. PE should be a consideration in many COPD exacerbations.

Citation: Rizkallah J, Man SF, Din DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009;135(3):786-793.

Targeted-Care Bundle Can Reduce ED Visits and Readmission Rates in High-Risk Elderly Patients

Clinical question: Can a care coordination bundle reduce length of stay (LOS), ED visits, or readmissions within 30 days of a hospital admission?

Background: Hospital-based care coordination interventions have shown mixed results in affecting LOS, post-discharge ED visits, and readmission rates. Although there has been some success with particular interventions, no consistent benefit has been demonstrated. Most notably, a recent meta-analysis of several different interventions showed no improvement in mortality, LOS, or readmission rates.

Study design: A randomized, controlled trial of select high-risk elderly patients.

Setting: A large teaching hospital at Baylor University Medical Center.

Synopsis: A “targeted-care bundle” was implemented with high-risk elderly patients to try to reduce LOS, readmissions, and ED visits. High-risk patients were identified by age, diagnosis-related group (DRG), number of medications at admission, comorbid conditions, and need for assistance in activities of daily living. Subjects were randomized to usual care or to receive a targeted-care bundle. The targeted-care bundle included multiple interventions. A study care coordinator provided daily patient education, including condition-specific teaching, discharge teaching and planning, and a follow-up phone call at five to seven days after discharge. A clinical pharmacist intervened for medication reconciliation at admission and discharge, medication teaching, and a follow-up phone call at five to seven days after discharge. Structured documents, including a personal health record and supplemental discharge form, were implemented.

The study had low enrollment, largely due to the requirement to obtain informed consent from all participants. Therefore, the study was underpowered to detect such target endpoints as LOS. A significant decrease in 30-day readmission rates/ED visits was noticed, but there was no persistent effect at 60 days.

The intervention was designed to use existing hospital staff in order to be practical for broad utilization. Future studies need to focus on increased enrollment to demonstrate beneficial effect.

 

Bottom line: Targeted health interventions focusing on education and coordination of care might effect some significant outcomes, most notably readmissions or ED visits within 30 days, but the nature of the clinical problem makes rigorous testing of interventions a challenge.

Citation: Kohler BE, Richter KM, Youngblood L, et al. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-218.

Family History Is a Risk Factor for Venous Thrombosis

Clinical question: Is family history of additional value in predicting an individual’s risk of venous thrombosis once a genetic risk factor is identified?

Background: A positive family history of venous thrombosis might suggest the presence of genetic risk factors in a given family. However, it is not known whether family history is of additional significance—once a risk factor is identified—in predicting an individual’s risk for venous thrombosis.

Study design: Population-based, case-control study.

Setting: Participants in the Multiple Environmental and Genetic Assessment (MEGA) of risk factors for venous thrombosis study.

Synopsis: Recruitment, data collection, and blood samples were obtained from individuals in the MEGA study. Participants completed a questionnaire about risk factors for venous thrombosis and family history. A positive family history more than doubled the risk of venous thrombosis, and when more than one family member was affected, the risk increased fourfold. The risk for venous thrombosis increased 64 times for individuals who had a family history, genetic risk factor, and environmental risk factor when compared with those with a negative family history and no known risk factors.

The underreporting or overestimation of the prevalence of a positive family history might limit this study.

Bottom line: Family history is a risk indictor for a first venous thrombosis, despite the presence of other risk factors.

Citation: Bezemer ID, van der Meer FJ, Eikenboom JC, Rosendaal FR, Doggen CJ. The value of family history as a risk indicator for venous thrombosis. Arch Intern Med. 2009;169(6):610-615.

Vasopressor Choice Predicts Mortality in Septic Shock

Clinical question: Does vasopressor choice affect mortality in patients with community-acquired septic shock?

Background: Community-acquired septic shock is a common illness and, despite aggressive care, a leading cause of death. Randomized clinical control trials evaluating the efficacy and safety of different adrenergic supportive agents are lacking. Thus, both norepinephrine and dopamine are recommended as first-line agents in the treatment of septic shock by the Surviving Sepsis Campaign guidelines.

Study design: Multicenter, cohort observational study.

Setting: Seventeen intensive-care units in Portugal.

Synopsis: In adjusted analysis controlling for Simplified Acute Physiology Score (SAPS) II, use of norepinephrine in community-acquired septic shock was associated with higher hospital mortality and lower 28-day survival when compared with dopamine. Specifically, patients treated with norepinephrine had a statistically significant higher hospital mortality rate than those treated with dopamine (52% and 38.5%, respectively, P=0.002) and a lower 28-day survival (log rank=22.6; P<0.001). While this data is valuable, the nonrandomized, observational study design limits firm conclusions regarding vasopressor choice. Further results from three large trials comparing vasopressor use in septic shock should continue to shed light on this debate.

Bottom line: Norepinephrine administration is associated with higher hospital mortality and lower 28-day survival when compared with dopamine in patients with community-acquired septic shock.

Citation: Póvoa PR, Carneiro AH, Ribeiro OS, Pereira AC, Portuguese Community-Acquired Sepsis Study Group. Influence of vasopressor agent in septic shock mortality. Results from the Portuguese Community-Acquired Sepsis Study (SACiUCI study). Crit Care Med. 2009;37(2):410-416.

 

Oral Vitamin K Versus Placebo to Correct Excess Anticoagulation in Warfarin Patients

Clinical question: In nonbleeding patients with warfarin-associated coagulopathy, does oral vitamin K reduce bleeding events when compared to placebo?

Background: Warfarin is a common drug for primary and secondary prevention of thromboembolism, but it requires continued monitoring of the international normalized ratio (INR) value. INR values >4.0 are associated with an increase in bleeding complications, with specific concern for intracranial bleeding when INR values exceed 4.5. Small, randomized trials have shown that single, low-dose administration of oral vitamin K effectively reduces the INR in nonbleeding, overanticoagulated patients.

However, these studies have not shown if vitamin K reduces risk for bleeding without increasing the risk for thromboembolism.

Study design: Randomized, placebo-controlled trial.

Setting: Fourteen anticoagulation clinics in Canada, Italy, and the U.S.

Synopsis: Nonbleeding patients with supratherapeutic INR values between 4.5 and 10.0 were randomly assigned to receive 1.25 mg of oral vitamin K or placebo, then evaluated for all forms of bleeding for 90 days. Bleeding events were defined as “major bleeding,” “minor bleeding,” and “trivial bleeding.”

Though patients who received oral vitamin K had a significantly more rapid INR decrease, there were no differences between the two groups with regard to all bleeding events, thromboembolism, or death. The study was underpowered to detect differences in major bleeding.

Bottom line: Low-dose oral vitamin K leads to more rapid correction of the INR in overanticoagulated patients on warfarin therapy, but has little effect on clinical outcomes at 90 days.

Citation: Crowther MA, Ageno W, Garcia D, et al. Oral vitamin K versus placebo to correct excessive anticoagulation in patients receiving warfarin: a randomized trial. Ann Intern Med. 2009;150(5):293-300.

Inappropriate Treatment of Catheter-Associated Asymptomatic Bacteriuria

Clinical question: Are hospitalized patients with urinary catheters inappropriately treated with antibiotics for asymptomatic bacteriuria?

Background: Persons with catheters acquire bacteriuria at the rate of 3% to 10% per day, but in the majority of cases, no symptoms or secondary complications occur. Evidenced-based guidelines state that asymptomatic bacteriuria is not a clinically significant infection, and numerous studies have shown that treatment is unlikely to confer clinical benefit.

Study design: Retrospective cohort study.

Setting: A single-site Veterans Affairs hospital.

Synopsis: Using urine culture results over a three-month period from a single VA medical center, 280 cases were analyzed: 164 catheter-associated asymptomatic bacteriuria and 116 catheter-associated urinary tract infections (UTIs). A UTI was defined as having one or more of these symptoms: fever, urgency, frequency, dysuria, suprapubic tenderness, altered mental status, or hypotension in a patient without another recognized infection and a positive urine culture. Of the asymptomatic bacteriuria cases, 68% were managed appropriately with no antibiotic treatment; 32% were inappropriately treated with antibiotics.

In multivariate analysis, older patient age, predominance of gram-negative bacteria, and higher urine white blood cell count were significantly associated with inappropriate treatment.

This study highlights the fact that antibiotics continue to be used inappropriately in patients with catheters. Current guidelines do not distinguish well between asymptomatic bacteriuria and UTI, so there might be a knowledge gap. This study was based on urine culture data, not urinalysis of all patients with a catheter, so the symptomatic patients were likely over-represented.

An associated editorial observes that the study extrapolates data from studies that involved patients with uncomplicated UTIs and, therefore, might reach erroneous conclusions. Further, viewing catheter-associated symptomatic UTIs and catheter-associated asymptomatic bactiuria as dichotomous and warranting inherently different management fails to encompass a number of clinical factors, including co-infection, and further fails to acknowledge that removal of the catheter is the first step in treatment. However, the finding that antibiotics continue to be used inappropriately is useful.

 

Bottom line: A clinical determination of whether a patient with a catheter really has a symptomatic UTI/urosepsis or only has asymptomatic bacteriuria should precede starting antibiotics in hospitalized patients.

Citations: Cope M, Cevallos ME, Cadle RM, Darouiche RO, Musher DM, Trautner BW. Inappropriate treatment of catheter-associated asymptomatic bateriuria in a tertiary care hospital. Clin Infect Dis. 2009;48(9):1182-1188.

Kunin CM. Catheter-associated urinary tract infections: a syllogism compounded by a questionable dichotomy. Clin Infect Dis. 2009;48:1189-1190.

Current Practices in the Evaluation and Management of Thrombocytopenia in Heparin Patients

Clinical question: Are the current American College of Chest Physicians (ACCP) guidelines for the recognition, treatment, and prevention of heparin-induced thrombocytopenia (HIT) being followed?

Background: Heparin-based anticoagulation is frequently given to hospitalized patients, and approximately 1% to 5% of these patients develop HIT. In 2004, the ACCP published a consensus statement on the evaluation, management, and prevention of HIT.

Study design: Prospective, observational study.

Setting: Forty-eight U.S. hospitals in the Complications After Thrombocytopenia Caused by Heparin (CATCH) registry.

Synopsis: The CATCH trial enrolled patients receiving any form of heparin for >96 hours (n=2,420), cardiac-care-unit patients treated with heparin (n=1,090), and patients who had an HIT antibody assay performed (n=449), for a total of 3,536 total patients. The study included patients on unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Thrombocytopenia was defined at a platelet count <150,000, or a decrease of 50% when compared with admission.

In the prolonged heparin group, 36.4% of patients developed thrombocytopenia; however, HIT was suspected in only 19.8% of these high-risk patients. While physicians were more likely to consider HIT in the cardiac-care patients (37.6%), the diagnosis was considered>24 hours after the thrombocytopenia developed. Physicians often waited until after a thromboembolic complication occurred before evaluating for HIT. More often than not, preventive measures were missed (e.g., failing to check for HIT antibodies, continuing heparin after HIT was suspected).

Bottom line: Thrombocytopenia is a common occurrence in patients receiving heparin and, despite the risk of devastating complications from HIT, treatment infrequently conforms to the established guidelines.

Citation: Crespo EM, Oliveira GBF, Honeycutt EF, et al. Evaluation and management of thrombocytopenia and suspected heparin-induced thrombocytopenia in hospitalized patients: The Complications After Thrombocytopenia Caused by Heparin (CATCH) registry. Am Heart J. 2009;157(4):651-657. TH

For hospitalists attending SHM’s Leadership Academy, the final day isn’t the end of the experience. It’s just the beginning.

Now in its fifth year, the Leadership Academy provides hospitalists of all backgrounds the opportunity to come together and address the managerial and practical issues of HM that aren’t covered in medical school. The demand for leadership training within the specialty has been so great that the Leadership Academy is now split into two levels; Level II is reserved for hospitalists who have completed the Level I program or have an MBA.

Level I covers the fundamental elements for leading groups—and change—within a hospital. Hospitalists learn how to take on leadership roles, better understand group dynamics, manage conflict, and improve communication.

Level II, which traditionally has had smaller class sizes, goes deeper into managerial issues that relate to hospital administration and leadership. The advanced program features such all-day sessions as “Financial Storytelling” and the popular “Meta-Leadership in Hospital Medicine.”

Leadership Academy’s true impact is felt shortly after hospitalists return to their hospitals. “Hospitalists send e-mails within a week of the end of Leadership Academy,” says Larry Wellikson, MD, FHM, CEO of SHM. “They tell us about the tangible actions that they’ve already taken as a result of what they’ve learned over the four days of Leadership Academy. … In just a few days, hospitalists learn from some of the best in the specialty and thought leaders outside of the field, too.”

Immediate Results

Hospitalists—and those who work with them—often see the change the academy has on a physician soon after the attendee returns to work. “It’s like a light bulb goes on,” says Rachel George, MD, regional medical director and vice president for operations at Brentwood, Tenn.-based Cogent Healthcare. “They get it. They come back from the Leadership Academy with an understanding of how to lead their own groups and manage through change.”

Dr. George, who attended Level I and Level II programs and now facilitates academy sessions, says Leadership Academy is “almost mandatory” for Cogent’s medical directors. The company encourages all of its physicians to attend.

One of the most valuable aspects of the program, she says, is the long-term impact. Dr. George completed the advanced course in 2005 and still enjoys catching up with her fellow academy attendees, as well as learning about what they have achieved in the subsequent years. Many classmates have become medical directors, and she says they credit the academy for many of the positive changes in their groups.

“It’s absolutely worth it,” she says. “Both levels are worth the time and investment. And ‘leadership’ doesn’t necessarily mean being a leader of your group. It can also mean being a leader of change and initiatives within the hospital.”

WENDY HOLDEN/ISTOCKPHOTO

Active Training for Active Leaders

Although the word “academy” might conjure ideas of long-winded seminars or Socratic debate, SHM’s Leadership Academy emphasizes a hands-on learning style. Hospitalists are divided into groups to tackle real-world issues that affect hospitals, hospitalists, and patients, such as QI initiatives and ED throughput.

The courses feature some of the most engaging speakers in HM and insightful presentations from experts outside of the specialty.

The faculty also includes nonphysicians; for example, Tim Keogh, PhD, who teaches postgraduate managerial communications at The Citadel School of Business Administration in Charleston, S.C., and Tulane University’s School of Public Health and Tropical Medicine in New Orleans, offers a unique perspective to hospitalists who are often accustomed to learning only from those within the specialty.

 

Young Specialty Grows Leaders

The Leadership Academy’s origins stem from HM’s youthful roots; the average age of a hospitalist is 40, and the average age of a hospitalist leader is 43, according to SHM’s 2007-2008 “Bi-Annual Survey on the State of the Hospital Medicine Movement.” Unlike more established medical fields, HM is in the unique position of cultivating the first generation of the specialty’s leadership. Through mentorship and motivation, the academy is arming hospitalists with the tools they’ll need to become leaders in a still-developing field.

Individuals within HM benefit from leadership training, too. “I see Leadership Academy as filling a real void in hospital medicine,” Dr. George says. “We’re still a young profession. We don’t have a lot of gray hair in the field, but we’re in the unusual position to work closely with hospital administrators.”

That paradigm means hospitalists have to learn to speak the language of administration, she says. And they need to learn it quick if they want to create real change and value. For Dr. George, who sees the academy’s impact from the hospitalist and executive perspectives, the academy prepares hospitalists to fill a necessary role in the hospital.

“As a relatively new profession, we still have to prove ourselves on a regular basis,” she says. TH

Brendon Shank is a freelance writer based in Philadelphia.

Chapter Updates

Southwest Wisconsin Chapter

Hospitalists from five HM groups met May 7 in Madison. Julia Wright, MD, FHM, clinical associate professor of medicine and director of hospital medicine at the University of Wisconsin School of Medicine and Public Health in Madison, spoke about “The State of Hospital Medicine.” Her presentation included an exploration of factors that influence and drive the specialty, as well as a look at HM demographics.

 

Northern Nevada

The Northern Nevada chapter met April 7 at the Charlie Palmer Steakhouse in Reno. The 36 attendees represented five HM groups. The meeting topic was “Difficult Decisions in Anticoagulation,” with guest speaker Christine Tankersley, PharmD, from Sanofi-Aventis Pharmaceuticals.

The chapter provided Tankersley with several real-patient cases that involved challenging decisions, and she led a step-wise discussion within the context of new American College of Clinial Pharmacy guidelines for anticoagulation.

Chapter President Phil Goodman, MD, FHM, stressed the importance of joining SHM and attending the annual meeting. It was decided to continue the community SHM journal club, which enjoyed a successful debut in September 2008, with 15 attendees reviewing a pair of New England Journal of Medicine articles at P.F. Chang’s in Reno.

Annual chapter elections were planned for the next meeting.

Long Island

The March 19 meeting provided SHM updates on the national meeting, advancement to fellowship opportunities, and a call to encourage HM group leaders to promote SHM membership.

A presentation on antibiotic stewardship revealed data on the improved clinical and economical outcomes of such a program in the hospital setting.

Connecticut

Joseph Ming-Wah Li, MD, FHM, director of the hospital medicine program at Beth Israel Deaconess Medical Center in Boston and an SHM board member, spoke at the March 25 chapter meeting. He discussed the exponential growth of HM as a specialty and reviewed data on hospitalist numbers past, present, and future.

Dr. Li also analyzed data from SHM’s 2007-2008 “Bi-Annual Survey on the State of Hospital Medicine,” and provided benchmarks for hospitalist productivity, night scheduling, administrative work, use of physician extenders, and residents.

Dr. Li’s talk was followed by a presentation on billing-capture software by Courtney Shickel from Ingenious Med Company. The demonstration touted the benefits of using the software for charge capture and some quality measures. The data showed the software can increase hospital revenues within 30 to 60 days of implementation, and lost charges were almost completely mitigated.

Upstate South Carolina

The March 19 meeting brought together nearly 20 attendees representing five hospitals in upstate South Carolina. Bruce Friedman, MD, of Doctor’s Hospital presented information on doripenem (Doribax).

Following the presentation, chapter President Imran Shaikh, MD, a hospitalist with Inpatient Medicine Service, directed the business meeting. Members discussed development of a chapter newsletter as well as an online forum to allow discussion of clinical and administrative issues.

Sanjeev Kumar, MD, a hospitalist with Hospital Medicine Consultants, will query members as to which portal would be most accessible to members, then proceed with establishing the forum.

Georgia Coastal

The April 16 chapter meeting featured SHM board member and president-elect Jeff Wiese, MD, FHM, speaking on the direction of HM and the progress of a board certification in hospital medicine.

This meeting was well attended by SHM members, including physician assistants and nurse practitioners.

For hospitalists attending SHM’s Leadership Academy, the final day isn’t the end of the experience. It’s just the beginning.

Now in its fifth year, the Leadership Academy provides hospitalists of all backgrounds the opportunity to come together and address the managerial and practical issues of HM that aren’t covered in medical school. The demand for leadership training within the specialty has been so great that the Leadership Academy is now split into two levels; Level II is reserved for hospitalists who have completed the Level I program or have an MBA.

Level I covers the fundamental elements for leading groups—and change—within a hospital. Hospitalists learn how to take on leadership roles, better understand group dynamics, manage conflict, and improve communication.

Level II, which traditionally has had smaller class sizes, goes deeper into managerial issues that relate to hospital administration and leadership. The advanced program features such all-day sessions as “Financial Storytelling” and the popular “Meta-Leadership in Hospital Medicine.”

Leadership Academy’s true impact is felt shortly after hospitalists return to their hospitals. “Hospitalists send e-mails within a week of the end of Leadership Academy,” says Larry Wellikson, MD, FHM, CEO of SHM. “They tell us about the tangible actions that they’ve already taken as a result of what they’ve learned over the four days of Leadership Academy. … In just a few days, hospitalists learn from some of the best in the specialty and thought leaders outside of the field, too.”

Immediate Results

Hospitalists—and those who work with them—often see the change the academy has on a physician soon after the attendee returns to work. “It’s like a light bulb goes on,” says Rachel George, MD, regional medical director and vice president for operations at Brentwood, Tenn.-based Cogent Healthcare. “They get it. They come back from the Leadership Academy with an understanding of how to lead their own groups and manage through change.”

Dr. George, who attended Level I and Level II programs and now facilitates academy sessions, says Leadership Academy is “almost mandatory” for Cogent’s medical directors. The company encourages all of its physicians to attend.

One of the most valuable aspects of the program, she says, is the long-term impact. Dr. George completed the advanced course in 2005 and still enjoys catching up with her fellow academy attendees, as well as learning about what they have achieved in the subsequent years. Many classmates have become medical directors, and she says they credit the academy for many of the positive changes in their groups.

“It’s absolutely worth it,” she says. “Both levels are worth the time and investment. And ‘leadership’ doesn’t necessarily mean being a leader of your group. It can also mean being a leader of change and initiatives within the hospital.”

WENDY HOLDEN/ISTOCKPHOTO

Active Training for Active Leaders

Although the word “academy” might conjure ideas of long-winded seminars or Socratic debate, SHM’s Leadership Academy emphasizes a hands-on learning style. Hospitalists are divided into groups to tackle real-world issues that affect hospitals, hospitalists, and patients, such as QI initiatives and ED throughput.

The courses feature some of the most engaging speakers in HM and insightful presentations from experts outside of the specialty.

The faculty also includes nonphysicians; for example, Tim Keogh, PhD, who teaches postgraduate managerial communications at The Citadel School of Business Administration in Charleston, S.C., and Tulane University’s School of Public Health and Tropical Medicine in New Orleans, offers a unique perspective to hospitalists who are often accustomed to learning only from those within the specialty.

 

Young Specialty Grows Leaders

The Leadership Academy’s origins stem from HM’s youthful roots; the average age of a hospitalist is 40, and the average age of a hospitalist leader is 43, according to SHM’s 2007-2008 “Bi-Annual Survey on the State of the Hospital Medicine Movement.” Unlike more established medical fields, HM is in the unique position of cultivating the first generation of the specialty’s leadership. Through mentorship and motivation, the academy is arming hospitalists with the tools they’ll need to become leaders in a still-developing field.

Individuals within HM benefit from leadership training, too. “I see Leadership Academy as filling a real void in hospital medicine,” Dr. George says. “We’re still a young profession. We don’t have a lot of gray hair in the field, but we’re in the unusual position to work closely with hospital administrators.”

That paradigm means hospitalists have to learn to speak the language of administration, she says. And they need to learn it quick if they want to create real change and value. For Dr. George, who sees the academy’s impact from the hospitalist and executive perspectives, the academy prepares hospitalists to fill a necessary role in the hospital.

“As a relatively new profession, we still have to prove ourselves on a regular basis,” she says. TH

Brendon Shank is a freelance writer based in Philadelphia.

Chapter Updates

Southwest Wisconsin Chapter

Hospitalists from five HM groups met May 7 in Madison. Julia Wright, MD, FHM, clinical associate professor of medicine and director of hospital medicine at the University of Wisconsin School of Medicine and Public Health in Madison, spoke about “The State of Hospital Medicine.” Her presentation included an exploration of factors that influence and drive the specialty, as well as a look at HM demographics.

 

Northern Nevada

The Northern Nevada chapter met April 7 at the Charlie Palmer Steakhouse in Reno. The 36 attendees represented five HM groups. The meeting topic was “Difficult Decisions in Anticoagulation,” with guest speaker Christine Tankersley, PharmD, from Sanofi-Aventis Pharmaceuticals.

The chapter provided Tankersley with several real-patient cases that involved challenging decisions, and she led a step-wise discussion within the context of new American College of Clinial Pharmacy guidelines for anticoagulation.

Chapter President Phil Goodman, MD, FHM, stressed the importance of joining SHM and attending the annual meeting. It was decided to continue the community SHM journal club, which enjoyed a successful debut in September 2008, with 15 attendees reviewing a pair of New England Journal of Medicine articles at P.F. Chang’s in Reno.

Annual chapter elections were planned for the next meeting.

Long Island

The March 19 meeting provided SHM updates on the national meeting, advancement to fellowship opportunities, and a call to encourage HM group leaders to promote SHM membership.

A presentation on antibiotic stewardship revealed data on the improved clinical and economical outcomes of such a program in the hospital setting.

Connecticut

Joseph Ming-Wah Li, MD, FHM, director of the hospital medicine program at Beth Israel Deaconess Medical Center in Boston and an SHM board member, spoke at the March 25 chapter meeting. He discussed the exponential growth of HM as a specialty and reviewed data on hospitalist numbers past, present, and future.

Dr. Li also analyzed data from SHM’s 2007-2008 “Bi-Annual Survey on the State of Hospital Medicine,” and provided benchmarks for hospitalist productivity, night scheduling, administrative work, use of physician extenders, and residents.

Dr. Li’s talk was followed by a presentation on billing-capture software by Courtney Shickel from Ingenious Med Company. The demonstration touted the benefits of using the software for charge capture and some quality measures. The data showed the software can increase hospital revenues within 30 to 60 days of implementation, and lost charges were almost completely mitigated.

Upstate South Carolina

The March 19 meeting brought together nearly 20 attendees representing five hospitals in upstate South Carolina. Bruce Friedman, MD, of Doctor’s Hospital presented information on doripenem (Doribax).

Following the presentation, chapter President Imran Shaikh, MD, a hospitalist with Inpatient Medicine Service, directed the business meeting. Members discussed development of a chapter newsletter as well as an online forum to allow discussion of clinical and administrative issues.

Sanjeev Kumar, MD, a hospitalist with Hospital Medicine Consultants, will query members as to which portal would be most accessible to members, then proceed with establishing the forum.

Georgia Coastal

The April 16 chapter meeting featured SHM board member and president-elect Jeff Wiese, MD, FHM, speaking on the direction of HM and the progress of a board certification in hospital medicine.

This meeting was well attended by SHM members, including physician assistants and nurse practitioners.

For hospitalists attending SHM’s Leadership Academy, the final day isn’t the end of the experience. It’s just the beginning.

Now in its fifth year, the Leadership Academy provides hospitalists of all backgrounds the opportunity to come together and address the managerial and practical issues of HM that aren’t covered in medical school. The demand for leadership training within the specialty has been so great that the Leadership Academy is now split into two levels; Level II is reserved for hospitalists who have completed the Level I program or have an MBA.

Level I covers the fundamental elements for leading groups—and change—within a hospital. Hospitalists learn how to take on leadership roles, better understand group dynamics, manage conflict, and improve communication.

Level II, which traditionally has had smaller class sizes, goes deeper into managerial issues that relate to hospital administration and leadership. The advanced program features such all-day sessions as “Financial Storytelling” and the popular “Meta-Leadership in Hospital Medicine.”

Leadership Academy’s true impact is felt shortly after hospitalists return to their hospitals. “Hospitalists send e-mails within a week of the end of Leadership Academy,” says Larry Wellikson, MD, FHM, CEO of SHM. “They tell us about the tangible actions that they’ve already taken as a result of what they’ve learned over the four days of Leadership Academy. … In just a few days, hospitalists learn from some of the best in the specialty and thought leaders outside of the field, too.”

Immediate Results

Hospitalists—and those who work with them—often see the change the academy has on a physician soon after the attendee returns to work. “It’s like a light bulb goes on,” says Rachel George, MD, regional medical director and vice president for operations at Brentwood, Tenn.-based Cogent Healthcare. “They get it. They come back from the Leadership Academy with an understanding of how to lead their own groups and manage through change.”

Dr. George, who attended Level I and Level II programs and now facilitates academy sessions, says Leadership Academy is “almost mandatory” for Cogent’s medical directors. The company encourages all of its physicians to attend.

One of the most valuable aspects of the program, she says, is the long-term impact. Dr. George completed the advanced course in 2005 and still enjoys catching up with her fellow academy attendees, as well as learning about what they have achieved in the subsequent years. Many classmates have become medical directors, and she says they credit the academy for many of the positive changes in their groups.

“It’s absolutely worth it,” she says. “Both levels are worth the time and investment. And ‘leadership’ doesn’t necessarily mean being a leader of your group. It can also mean being a leader of change and initiatives within the hospital.”

WENDY HOLDEN/ISTOCKPHOTO

Active Training for Active Leaders

Although the word “academy” might conjure ideas of long-winded seminars or Socratic debate, SHM’s Leadership Academy emphasizes a hands-on learning style. Hospitalists are divided into groups to tackle real-world issues that affect hospitals, hospitalists, and patients, such as QI initiatives and ED throughput.

The courses feature some of the most engaging speakers in HM and insightful presentations from experts outside of the specialty.

The faculty also includes nonphysicians; for example, Tim Keogh, PhD, who teaches postgraduate managerial communications at The Citadel School of Business Administration in Charleston, S.C., and Tulane University’s School of Public Health and Tropical Medicine in New Orleans, offers a unique perspective to hospitalists who are often accustomed to learning only from those within the specialty.

 

Young Specialty Grows Leaders

The Leadership Academy’s origins stem from HM’s youthful roots; the average age of a hospitalist is 40, and the average age of a hospitalist leader is 43, according to SHM’s 2007-2008 “Bi-Annual Survey on the State of the Hospital Medicine Movement.” Unlike more established medical fields, HM is in the unique position of cultivating the first generation of the specialty’s leadership. Through mentorship and motivation, the academy is arming hospitalists with the tools they’ll need to become leaders in a still-developing field.

Individuals within HM benefit from leadership training, too. “I see Leadership Academy as filling a real void in hospital medicine,” Dr. George says. “We’re still a young profession. We don’t have a lot of gray hair in the field, but we’re in the unusual position to work closely with hospital administrators.”

That paradigm means hospitalists have to learn to speak the language of administration, she says. And they need to learn it quick if they want to create real change and value. For Dr. George, who sees the academy’s impact from the hospitalist and executive perspectives, the academy prepares hospitalists to fill a necessary role in the hospital.

“As a relatively new profession, we still have to prove ourselves on a regular basis,” she says. TH

Brendon Shank is a freelance writer based in Philadelphia.

Chapter Updates

Southwest Wisconsin Chapter

Hospitalists from five HM groups met May 7 in Madison. Julia Wright, MD, FHM, clinical associate professor of medicine and director of hospital medicine at the University of Wisconsin School of Medicine and Public Health in Madison, spoke about “The State of Hospital Medicine.” Her presentation included an exploration of factors that influence and drive the specialty, as well as a look at HM demographics.

 

Northern Nevada

The Northern Nevada chapter met April 7 at the Charlie Palmer Steakhouse in Reno. The 36 attendees represented five HM groups. The meeting topic was “Difficult Decisions in Anticoagulation,” with guest speaker Christine Tankersley, PharmD, from Sanofi-Aventis Pharmaceuticals.

The chapter provided Tankersley with several real-patient cases that involved challenging decisions, and she led a step-wise discussion within the context of new American College of Clinial Pharmacy guidelines for anticoagulation.

Chapter President Phil Goodman, MD, FHM, stressed the importance of joining SHM and attending the annual meeting. It was decided to continue the community SHM journal club, which enjoyed a successful debut in September 2008, with 15 attendees reviewing a pair of New England Journal of Medicine articles at P.F. Chang’s in Reno.

Annual chapter elections were planned for the next meeting.

Long Island

The March 19 meeting provided SHM updates on the national meeting, advancement to fellowship opportunities, and a call to encourage HM group leaders to promote SHM membership.

A presentation on antibiotic stewardship revealed data on the improved clinical and economical outcomes of such a program in the hospital setting.

Connecticut

Joseph Ming-Wah Li, MD, FHM, director of the hospital medicine program at Beth Israel Deaconess Medical Center in Boston and an SHM board member, spoke at the March 25 chapter meeting. He discussed the exponential growth of HM as a specialty and reviewed data on hospitalist numbers past, present, and future.

Dr. Li also analyzed data from SHM’s 2007-2008 “Bi-Annual Survey on the State of Hospital Medicine,” and provided benchmarks for hospitalist productivity, night scheduling, administrative work, use of physician extenders, and residents.

Dr. Li’s talk was followed by a presentation on billing-capture software by Courtney Shickel from Ingenious Med Company. The demonstration touted the benefits of using the software for charge capture and some quality measures. The data showed the software can increase hospital revenues within 30 to 60 days of implementation, and lost charges were almost completely mitigated.

Upstate South Carolina

The March 19 meeting brought together nearly 20 attendees representing five hospitals in upstate South Carolina. Bruce Friedman, MD, of Doctor’s Hospital presented information on doripenem (Doribax).

Following the presentation, chapter President Imran Shaikh, MD, a hospitalist with Inpatient Medicine Service, directed the business meeting. Members discussed development of a chapter newsletter as well as an online forum to allow discussion of clinical and administrative issues.

Sanjeev Kumar, MD, a hospitalist with Hospital Medicine Consultants, will query members as to which portal would be most accessible to members, then proceed with establishing the forum.

Georgia Coastal

The April 16 chapter meeting featured SHM board member and president-elect Jeff Wiese, MD, FHM, speaking on the direction of HM and the progress of a board certification in hospital medicine.

This meeting was well attended by SHM members, including physician assistants and nurse practitioners.

A hospitalist who scrutinizes claims might notice a payment denial related to “unbundling” issues. Line-item rejections might state the service is “mutually exclusive,” “incidental to another procedure,” or “payment was received as part of another service/procedure.” Unbundling refers to the practice of reporting each component of a service or procedure instead of reporting the single, comprehensive code. Two types of practices lead to unbundling: unintentional reporting resulting from a basic misunderstanding of correct coding, and intentional reporting to improperly maximize payment of otherwise bundled Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.1

The Centers for Medicare and Medicaid Services (CMS) developed the National Correct Coding Initiative (NCCI) for implementation and application to physician claims (e.g., Medicare Part B) with dates of service on or after Jan. 1, 1996. The rationale for these edits is a culmination of:

• Coding standards identified in the American Medical Association’s (AMA) CPT manual;
• National and local coverage determinations developed by CMS and local Medicare contractors;
• Coding standards set forth by national medical organizations and specialty societies;
• Appropriate standards of medical and surgical care; and
• Current coding practices identified through claim analysis, pre- and post-payment documentation reviews, and other forms of payor-initiated audit.

The initial NCCI goal was to promote correct coding methodologies and to control improper coding, which led to inappropriate payment in Part B claims.2 It later expanded to include corresponding NCCI edits in the outpatient code editor (OCE) for both outpatient hospital providers and therapy providers. Therapy providers encompass skilled nursing facilities (SNFs), comprehensive outpatient rehabilitation facilities (CORFs), outpatient physical therapy (OPTs) and speech-language pathology providers, and home health agencies (HHAs).

Fact-Check

The NCCI recognizes two edit types: Column One/Column Two Correct Coding edits and Mutually Exclusive edits. Each of these edit categories lists code pairs that should not be reported together on the same date by either a single physician or physicians of the same specialty within a provider group.

 

When applying Column One/Column Two editing logic to physician claims, the Column One code represents the more comprehensive code of the pair being reported. The Column Two code (the component service that is bundled into the comprehensive service) will be denied. This is not to say a code that appears in Column Two of the NCCI cannot be paid when reported by itself on any given date. The denial occurs only when the component service is reported on the same date as the more comprehensive service.

For example, CPT code 36556 (insertion of nontunneled centrally inserted central venous catheter, age 5 years or older) is considered comprehensive to codes 36000 (introduction of needle or intracatheter, vein) and 36410 (venipuncture, age 3 years or older, necessitating physician’s skill [separate procedure], for diagnostic or therapeutic purposes). These code combinations should not be reported together on the same date when performed as part of the same procedure by the same physician or physicians of the same practice group. If this occurs, the payor will reimburse the initial service and deny the subsequent service. As a result, the first code received by the payor, on the same or separate claims, is reimbursed, even if that code represents the lesser of the two services.

Mutually Exclusive edits occur with less frequency than Column One/Column Two edits. Mutually Exclusive edits prevent reporting of two services or procedures that are highly unlikely to be performed together on the same patient, at the same session or encounter, by the same physician or physicians of the same specialty in a provider group. For example, CPT code 36556 (insertion of nontunneled centrally inserted central venous catheter, age 5 years or older) would not be reported on the same day as 36555 (insertion of nontunneled centrally inserted central venous catheter, younger than 5 years of age).

CMS publishes the National Correct Coding Initiative Coding Policy Manual for Medicare Services (www.cms.hhs.gov/NationalCorrectCodInitEd) and encourages local Medicare contractors and fiscal intermediaries to use it as a reference for claims-processing edits. The manual is updated annually, and the NCCI edits are updated quarterly. TH

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center in Philadelphia. She is faculty of SHM’s inpatient coding course.

References

1. National correct coding initiative edits. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/NationalCorrectCodInitEd. Accessed March 10, 2009.
2. Medicare claims processing manual. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/manuals/downloads/clm104c12.pdf. Accessed March 10, 2009.
3. Beebe M, Dalton J, Espronceda M, Evans D, Glenn R. Current Procedural Terminology Professional Edition. Chicago: American Medical Association Press, 2008;477-481.
4. Modifier 59 article. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/NationalCorrectCodInitEd/Downloads/modifier59.pdf. Accessed March 10, 2009.
5. French K. Coding for Chest Medicine 2009. Northbrook, IL: American College of Chest Physicians. 2008;283-287.

A hospitalist who scrutinizes claims might notice a payment denial related to “unbundling” issues. Line-item rejections might state the service is “mutually exclusive,” “incidental to another procedure,” or “payment was received as part of another service/procedure.” Unbundling refers to the practice of reporting each component of a service or procedure instead of reporting the single, comprehensive code. Two types of practices lead to unbundling: unintentional reporting resulting from a basic misunderstanding of correct coding, and intentional reporting to improperly maximize payment of otherwise bundled Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.1

The Centers for Medicare and Medicaid Services (CMS) developed the National Correct Coding Initiative (NCCI) for implementation and application to physician claims (e.g., Medicare Part B) with dates of service on or after Jan. 1, 1996. The rationale for these edits is a culmination of:

• Coding standards identified in the American Medical Association’s (AMA) CPT manual;
• National and local coverage determinations developed by CMS and local Medicare contractors;
• Coding standards set forth by national medical organizations and specialty societies;
• Appropriate standards of medical and surgical care; and
• Current coding practices identified through claim analysis, pre- and post-payment documentation reviews, and other forms of payor-initiated audit.

The initial NCCI goal was to promote correct coding methodologies and to control improper coding, which led to inappropriate payment in Part B claims.2 It later expanded to include corresponding NCCI edits in the outpatient code editor (OCE) for both outpatient hospital providers and therapy providers. Therapy providers encompass skilled nursing facilities (SNFs), comprehensive outpatient rehabilitation facilities (CORFs), outpatient physical therapy (OPTs) and speech-language pathology providers, and home health agencies (HHAs).

Fact-Check

The NCCI recognizes two edit types: Column One/Column Two Correct Coding edits and Mutually Exclusive edits. Each of these edit categories lists code pairs that should not be reported together on the same date by either a single physician or physicians of the same specialty within a provider group.

 

When applying Column One/Column Two editing logic to physician claims, the Column One code represents the more comprehensive code of the pair being reported. The Column Two code (the component service that is bundled into the comprehensive service) will be denied. This is not to say a code that appears in Column Two of the NCCI cannot be paid when reported by itself on any given date. The denial occurs only when the component service is reported on the same date as the more comprehensive service.

For example, CPT code 36556 (insertion of nontunneled centrally inserted central venous catheter, age 5 years or older) is considered comprehensive to codes 36000 (introduction of needle or intracatheter, vein) and 36410 (venipuncture, age 3 years or older, necessitating physician’s skill [separate procedure], for diagnostic or therapeutic purposes). These code combinations should not be reported together on the same date when performed as part of the same procedure by the same physician or physicians of the same practice group. If this occurs, the payor will reimburse the initial service and deny the subsequent service. As a result, the first code received by the payor, on the same or separate claims, is reimbursed, even if that code represents the lesser of the two services.

Mutually Exclusive edits occur with less frequency than Column One/Column Two edits. Mutually Exclusive edits prevent reporting of two services or procedures that are highly unlikely to be performed together on the same patient, at the same session or encounter, by the same physician or physicians of the same specialty in a provider group. For example, CPT code 36556 (insertion of nontunneled centrally inserted central venous catheter, age 5 years or older) would not be reported on the same day as 36555 (insertion of nontunneled centrally inserted central venous catheter, younger than 5 years of age).

CMS publishes the National Correct Coding Initiative Coding Policy Manual for Medicare Services (www.cms.hhs.gov/NationalCorrectCodInitEd) and encourages local Medicare contractors and fiscal intermediaries to use it as a reference for claims-processing edits. The manual is updated annually, and the NCCI edits are updated quarterly. TH

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center in Philadelphia. She is faculty of SHM’s inpatient coding course.

References

1. National correct coding initiative edits. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/NationalCorrectCodInitEd. Accessed March 10, 2009.
2. Medicare claims processing manual. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/manuals/downloads/clm104c12.pdf. Accessed March 10, 2009.
3. Beebe M, Dalton J, Espronceda M, Evans D, Glenn R. Current Procedural Terminology Professional Edition. Chicago: American Medical Association Press, 2008;477-481.
4. Modifier 59 article. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/NationalCorrectCodInitEd/Downloads/modifier59.pdf. Accessed March 10, 2009.
5. French K. Coding for Chest Medicine 2009. Northbrook, IL: American College of Chest Physicians. 2008;283-287.

A hospitalist who scrutinizes claims might notice a payment denial related to “unbundling” issues. Line-item rejections might state the service is “mutually exclusive,” “incidental to another procedure,” or “payment was received as part of another service/procedure.” Unbundling refers to the practice of reporting each component of a service or procedure instead of reporting the single, comprehensive code. Two types of practices lead to unbundling: unintentional reporting resulting from a basic misunderstanding of correct coding, and intentional reporting to improperly maximize payment of otherwise bundled Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.1

The Centers for Medicare and Medicaid Services (CMS) developed the National Correct Coding Initiative (NCCI) for implementation and application to physician claims (e.g., Medicare Part B) with dates of service on or after Jan. 1, 1996. The rationale for these edits is a culmination of:

• Coding standards identified in the American Medical Association’s (AMA) CPT manual;
• National and local coverage determinations developed by CMS and local Medicare contractors;
• Coding standards set forth by national medical organizations and specialty societies;
• Appropriate standards of medical and surgical care; and
• Current coding practices identified through claim analysis, pre- and post-payment documentation reviews, and other forms of payor-initiated audit.

The initial NCCI goal was to promote correct coding methodologies and to control improper coding, which led to inappropriate payment in Part B claims.2 It later expanded to include corresponding NCCI edits in the outpatient code editor (OCE) for both outpatient hospital providers and therapy providers. Therapy providers encompass skilled nursing facilities (SNFs), comprehensive outpatient rehabilitation facilities (CORFs), outpatient physical therapy (OPTs) and speech-language pathology providers, and home health agencies (HHAs).

Fact-Check

The NCCI recognizes two edit types: Column One/Column Two Correct Coding edits and Mutually Exclusive edits. Each of these edit categories lists code pairs that should not be reported together on the same date by either a single physician or physicians of the same specialty within a provider group.

 

When applying Column One/Column Two editing logic to physician claims, the Column One code represents the more comprehensive code of the pair being reported. The Column Two code (the component service that is bundled into the comprehensive service) will be denied. This is not to say a code that appears in Column Two of the NCCI cannot be paid when reported by itself on any given date. The denial occurs only when the component service is reported on the same date as the more comprehensive service.

For example, CPT code 36556 (insertion of nontunneled centrally inserted central venous catheter, age 5 years or older) is considered comprehensive to codes 36000 (introduction of needle or intracatheter, vein) and 36410 (venipuncture, age 3 years or older, necessitating physician’s skill [separate procedure], for diagnostic or therapeutic purposes). These code combinations should not be reported together on the same date when performed as part of the same procedure by the same physician or physicians of the same practice group. If this occurs, the payor will reimburse the initial service and deny the subsequent service. As a result, the first code received by the payor, on the same or separate claims, is reimbursed, even if that code represents the lesser of the two services.

Mutually Exclusive edits occur with less frequency than Column One/Column Two edits. Mutually Exclusive edits prevent reporting of two services or procedures that are highly unlikely to be performed together on the same patient, at the same session or encounter, by the same physician or physicians of the same specialty in a provider group. For example, CPT code 36556 (insertion of nontunneled centrally inserted central venous catheter, age 5 years or older) would not be reported on the same day as 36555 (insertion of nontunneled centrally inserted central venous catheter, younger than 5 years of age).

CMS publishes the National Correct Coding Initiative Coding Policy Manual for Medicare Services (www.cms.hhs.gov/NationalCorrectCodInitEd) and encourages local Medicare contractors and fiscal intermediaries to use it as a reference for claims-processing edits. The manual is updated annually, and the NCCI edits are updated quarterly. TH

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center in Philadelphia. She is faculty of SHM’s inpatient coding course.

References

1. National correct coding initiative edits. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/NationalCorrectCodInitEd. Accessed March 10, 2009.
2. Medicare claims processing manual. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/manuals/downloads/clm104c12.pdf. Accessed March 10, 2009.
3. Beebe M, Dalton J, Espronceda M, Evans D, Glenn R. Current Procedural Terminology Professional Edition. Chicago: American Medical Association Press, 2008;477-481.
4. Modifier 59 article. Centers for Medicare and Medicaid Services Web site. Available at: www.cms.hhs.gov/NationalCorrectCodInitEd/Downloads/modifier59.pdf. Accessed March 10, 2009.
5. French K. Coding for Chest Medicine 2009. Northbrook, IL: American College of Chest Physicians. 2008;283-287.

Some healthcare providers probably missed an important change buried within the 2009 Medicare Physician Fee Schedule: New rules for physician enrollment have drastically reduced the period for retroactive billing. Effective April 1, physicians enrolling or re-enrolling with Medicare can only submit a bill for services provided up to 30 days prior to the effective date, rather than for the prior 27 months.

Those who miss this deadline will be denied reimbursement for services to Medicare patients seen before the deadline. And those who move to a new job (“change of location,” in Medicare parlance) and fail to update their address within 30 days risk a two-year suspension from receiving Medicare payments.

What It Means

Essentially, HM group leaders must make sure they are ready to credential a new hire long before they start working. Before now, groups had months to get new hires enrolled in the Medicare system; now, with just 30 days to enroll, you need to start your credentialing and enrollment process early—before the physician’s start date, if possible.

“In a nutshell, groups are going to have to be more proactive than ever before in getting paperwork submitted for new providers,” says Derise Woods, operations project manager for Knoxville, Tenn.-based TeamHealth. “The situation we often face is that the provider is found and placed, and sometimes the paperwork does not get submitted right away. The natural focus is to get them on board and then get them up and running.”

If that is the case in your group, you should create a checklist for enrollment in Medicare and for other payors. Then, as soon as your new hire signs the contract, require them to submit all available information (e.g., DEA number and proof of board certification).

Woods says the rule states that “retroactive billing can start from the provider’s start date or from the date the enrollment is received at [Medicare], whichever is later.”

Even if you don’t capture all the necessary information, enroll the new physician as soon as possible. According to the Centers for Medicare & Medicaid Services (CMS), incomplete applications will be denied, but the date of the original filing will be preserved. So if a hospitalist begins working for your group Sept. 1, and you submit the enrollment application Sept. 7, the hospitalist can bill retroactively starting Sept. 7, even if that application is kicked back to you for more information and doesn’t get resolved for several weeks.

Large and Small Groups

Missing the new enrollment deadline means reimbursement losses. Hospitalists provide services to a significant number of Medicare patients, so cutting back on retroactive billing could hurt the bottom line. “In most [HM] instances where Medicare is a large portion of income, this has potential to disrupt a practice,” Woods says, noting TeamHealth has yet to see the impact of the new enrollment rules.

 

Which entity incurs the loss of Medicare payments depends on your program’s payment structure. “For instance, TeamHealth contracts with our providers and pays them an hourly rate,” says Woods, explaining that the third-party contractor will suffer any loss of fees. “In a hospital-based program, the hospital might bill for the provider—and that provider may not get paid.”

Smaller HM groups might not have as much experience with these changes simply because they don’t hire physicians as often. “I did not know about this,” says Heidi Tessler, MD, president of the Colorado Hospitalist Company in Denver. “We contract with a billing company [for physician enrollments], and we would have been caught flat-footed with our next hire.”

Small groups could end up scrambling when they need to fill a position, especially if it’s a quick turnover. Groups that outsource their recruiting and billing should plan to communicate with those companies to expedite the enrollment process, Woods says.

TeamHealth, the largest provider of hospital-based clinical outsourcing in the U.S., has made numerous changes to accommodate the new enrollment rules, all the way up to a new business development group. “They now take this new rule into consideration when we are planning to start providing service,” Woods says. “Our recruiters are helping. They are ensuring that new providers fill out their paperwork and get it in. Understandably, physicians can let paperwork sit for a number of days.”

The good news is CMS has made it easier—and faster—to enroll through a Web-based portal called PECOS (Provider Enrollment, Chain, and Ownership System), which can be accessed at www.cms.hhs.gov/MedicareProviderSupEnroll/.

Central Source

SHM has consolidated essential sources on the new rules to include:

• Medicare’s all-inclusive Web section on provider enrollment is www.cms.hhs.gov/medicareprovidersupenroll.
• The CMS manual on enrollment is at www.cms.hhs.gov. Click on “manuals,” then “Internet-only manuals”; select “Publication 100-08, Program Integrity Manual,” then “Chapter 10.”
• AMA provides an overview on its Web site, and, with the Medical Group Management Association (MGMA), has developed a toolkit to guide physicians through the new rules. “The toolkit is probably the best resource available,” says Leslie Flores, principal in Nelson/Flores Associates, a national hospitalist management consulting firm and director of SHM’s Practice Management Institute. AMA and MGMA members can access the toolkit at www.mgma.com/policy/default.aspx?id=5712.

“SHM wants to make sure we communicate these new rules to our members,” says Flores, “and provide direction to resources they can use.” Check www.hospitalmedicine.org for the latest links and information. TH

Jane Jerrard is a freelance writer based in Chicago.

Some healthcare providers probably missed an important change buried within the 2009 Medicare Physician Fee Schedule: New rules for physician enrollment have drastically reduced the period for retroactive billing. Effective April 1, physicians enrolling or re-enrolling with Medicare can only submit a bill for services provided up to 30 days prior to the effective date, rather than for the prior 27 months.

Those who miss this deadline will be denied reimbursement for services to Medicare patients seen before the deadline. And those who move to a new job (“change of location,” in Medicare parlance) and fail to update their address within 30 days risk a two-year suspension from receiving Medicare payments.

What It Means

Essentially, HM group leaders must make sure they are ready to credential a new hire long before they start working. Before now, groups had months to get new hires enrolled in the Medicare system; now, with just 30 days to enroll, you need to start your credentialing and enrollment process early—before the physician’s start date, if possible.

“In a nutshell, groups are going to have to be more proactive than ever before in getting paperwork submitted for new providers,” says Derise Woods, operations project manager for Knoxville, Tenn.-based TeamHealth. “The situation we often face is that the provider is found and placed, and sometimes the paperwork does not get submitted right away. The natural focus is to get them on board and then get them up and running.”

If that is the case in your group, you should create a checklist for enrollment in Medicare and for other payors. Then, as soon as your new hire signs the contract, require them to submit all available information (e.g., DEA number and proof of board certification).

Woods says the rule states that “retroactive billing can start from the provider’s start date or from the date the enrollment is received at [Medicare], whichever is later.”

Even if you don’t capture all the necessary information, enroll the new physician as soon as possible. According to the Centers for Medicare & Medicaid Services (CMS), incomplete applications will be denied, but the date of the original filing will be preserved. So if a hospitalist begins working for your group Sept. 1, and you submit the enrollment application Sept. 7, the hospitalist can bill retroactively starting Sept. 7, even if that application is kicked back to you for more information and doesn’t get resolved for several weeks.

Large and Small Groups

Missing the new enrollment deadline means reimbursement losses. Hospitalists provide services to a significant number of Medicare patients, so cutting back on retroactive billing could hurt the bottom line. “In most [HM] instances where Medicare is a large portion of income, this has potential to disrupt a practice,” Woods says, noting TeamHealth has yet to see the impact of the new enrollment rules.

 

Which entity incurs the loss of Medicare payments depends on your program’s payment structure. “For instance, TeamHealth contracts with our providers and pays them an hourly rate,” says Woods, explaining that the third-party contractor will suffer any loss of fees. “In a hospital-based program, the hospital might bill for the provider—and that provider may not get paid.”

Smaller HM groups might not have as much experience with these changes simply because they don’t hire physicians as often. “I did not know about this,” says Heidi Tessler, MD, president of the Colorado Hospitalist Company in Denver. “We contract with a billing company [for physician enrollments], and we would have been caught flat-footed with our next hire.”

Small groups could end up scrambling when they need to fill a position, especially if it’s a quick turnover. Groups that outsource their recruiting and billing should plan to communicate with those companies to expedite the enrollment process, Woods says.

TeamHealth, the largest provider of hospital-based clinical outsourcing in the U.S., has made numerous changes to accommodate the new enrollment rules, all the way up to a new business development group. “They now take this new rule into consideration when we are planning to start providing service,” Woods says. “Our recruiters are helping. They are ensuring that new providers fill out their paperwork and get it in. Understandably, physicians can let paperwork sit for a number of days.”

The good news is CMS has made it easier—and faster—to enroll through a Web-based portal called PECOS (Provider Enrollment, Chain, and Ownership System), which can be accessed at www.cms.hhs.gov/MedicareProviderSupEnroll/.

Central Source

SHM has consolidated essential sources on the new rules to include:

• Medicare’s all-inclusive Web section on provider enrollment is www.cms.hhs.gov/medicareprovidersupenroll.
• The CMS manual on enrollment is at www.cms.hhs.gov. Click on “manuals,” then “Internet-only manuals”; select “Publication 100-08, Program Integrity Manual,” then “Chapter 10.”
• AMA provides an overview on its Web site, and, with the Medical Group Management Association (MGMA), has developed a toolkit to guide physicians through the new rules. “The toolkit is probably the best resource available,” says Leslie Flores, principal in Nelson/Flores Associates, a national hospitalist management consulting firm and director of SHM’s Practice Management Institute. AMA and MGMA members can access the toolkit at www.mgma.com/policy/default.aspx?id=5712.

“SHM wants to make sure we communicate these new rules to our members,” says Flores, “and provide direction to resources they can use.” Check www.hospitalmedicine.org for the latest links and information. TH

Jane Jerrard is a freelance writer based in Chicago.

Some healthcare providers probably missed an important change buried within the 2009 Medicare Physician Fee Schedule: New rules for physician enrollment have drastically reduced the period for retroactive billing. Effective April 1, physicians enrolling or re-enrolling with Medicare can only submit a bill for services provided up to 30 days prior to the effective date, rather than for the prior 27 months.

Those who miss this deadline will be denied reimbursement for services to Medicare patients seen before the deadline. And those who move to a new job (“change of location,” in Medicare parlance) and fail to update their address within 30 days risk a two-year suspension from receiving Medicare payments.

What It Means

Essentially, HM group leaders must make sure they are ready to credential a new hire long before they start working. Before now, groups had months to get new hires enrolled in the Medicare system; now, with just 30 days to enroll, you need to start your credentialing and enrollment process early—before the physician’s start date, if possible.

“In a nutshell, groups are going to have to be more proactive than ever before in getting paperwork submitted for new providers,” says Derise Woods, operations project manager for Knoxville, Tenn.-based TeamHealth. “The situation we often face is that the provider is found and placed, and sometimes the paperwork does not get submitted right away. The natural focus is to get them on board and then get them up and running.”

If that is the case in your group, you should create a checklist for enrollment in Medicare and for other payors. Then, as soon as your new hire signs the contract, require them to submit all available information (e.g., DEA number and proof of board certification).

Woods says the rule states that “retroactive billing can start from the provider’s start date or from the date the enrollment is received at [Medicare], whichever is later.”

Even if you don’t capture all the necessary information, enroll the new physician as soon as possible. According to the Centers for Medicare & Medicaid Services (CMS), incomplete applications will be denied, but the date of the original filing will be preserved. So if a hospitalist begins working for your group Sept. 1, and you submit the enrollment application Sept. 7, the hospitalist can bill retroactively starting Sept. 7, even if that application is kicked back to you for more information and doesn’t get resolved for several weeks.

Large and Small Groups

Missing the new enrollment deadline means reimbursement losses. Hospitalists provide services to a significant number of Medicare patients, so cutting back on retroactive billing could hurt the bottom line. “In most [HM] instances where Medicare is a large portion of income, this has potential to disrupt a practice,” Woods says, noting TeamHealth has yet to see the impact of the new enrollment rules.

 

Which entity incurs the loss of Medicare payments depends on your program’s payment structure. “For instance, TeamHealth contracts with our providers and pays them an hourly rate,” says Woods, explaining that the third-party contractor will suffer any loss of fees. “In a hospital-based program, the hospital might bill for the provider—and that provider may not get paid.”

Smaller HM groups might not have as much experience with these changes simply because they don’t hire physicians as often. “I did not know about this,” says Heidi Tessler, MD, president of the Colorado Hospitalist Company in Denver. “We contract with a billing company [for physician enrollments], and we would have been caught flat-footed with our next hire.”

Small groups could end up scrambling when they need to fill a position, especially if it’s a quick turnover. Groups that outsource their recruiting and billing should plan to communicate with those companies to expedite the enrollment process, Woods says.

TeamHealth, the largest provider of hospital-based clinical outsourcing in the U.S., has made numerous changes to accommodate the new enrollment rules, all the way up to a new business development group. “They now take this new rule into consideration when we are planning to start providing service,” Woods says. “Our recruiters are helping. They are ensuring that new providers fill out their paperwork and get it in. Understandably, physicians can let paperwork sit for a number of days.”

The good news is CMS has made it easier—and faster—to enroll through a Web-based portal called PECOS (Provider Enrollment, Chain, and Ownership System), which can be accessed at www.cms.hhs.gov/MedicareProviderSupEnroll/.

Central Source

SHM has consolidated essential sources on the new rules to include:

• Medicare’s all-inclusive Web section on provider enrollment is www.cms.hhs.gov/medicareprovidersupenroll.
• The CMS manual on enrollment is at www.cms.hhs.gov. Click on “manuals,” then “Internet-only manuals”; select “Publication 100-08, Program Integrity Manual,” then “Chapter 10.”
• AMA provides an overview on its Web site, and, with the Medical Group Management Association (MGMA), has developed a toolkit to guide physicians through the new rules. “The toolkit is probably the best resource available,” says Leslie Flores, principal in Nelson/Flores Associates, a national hospitalist management consulting firm and director of SHM’s Practice Management Institute. AMA and MGMA members can access the toolkit at www.mgma.com/policy/default.aspx?id=5712.

“SHM wants to make sure we communicate these new rules to our members,” says Flores, “and provide direction to resources they can use.” Check www.hospitalmedicine.org for the latest links and information. TH

Jane Jerrard is a freelance writer based in Chicago.

Case

A previously healthy 55-year-old white female presents to the ED with a three-day history of pain and erythema in her right hand. Examination reveals fluctuance as well. She is diagnosed with an abscess with surrounding cellulitis. The abscess is incised, drained, and cultured, and she is sent home on oral trimethoprim/sulfamethoxazole. The following day, her cellulitis has worsened. She is hospitalized and commenced on intravenous vancomycin. What is the best empiric therapy for community-acquired cellulitis?

Background

Cellulitis is defined as a skin and soft-tissue infection (SSTI), which develops as a result of bacterial entry via breaches in the skin barrier. Typically, it involves the dermis and subcutaneous tissue, and is associated with local tenderness, erythema, swelling and fever. Cellulitis usually affects the lower extremities, but can affect other locations resulting in diagnoses such as periorbital, abdominal wall, buccal, and perianal cellulitis.1,2

Gram-positive organisms, especially Staphylococcus aureus and beta hemolytic streptococci, are the most common causes of cellulitis. Although it is less common, cellulitis can be caused by gram-negative organisms. The recent significant increase in the prevalence of SSTIs due to community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has led to changes in the selection of antibiotics that were most commonly utilized to empirically treat cellulitis.

The diagnosis of cellulitis is based primarily on clinical manifestations. Due to low diagnostic yields, blood cultures, needle aspiration, or punch biopsy, specimens usually are not helpful in the setting of simple cellulitis.3 Therefore, antibiotic therapy is almost universally started empirically. Starting appropriate initial antibiotic therapy improves patient outcomes by reducing mortality rates, length of stay, and inpatient costs.4

Cellulitis incidence is about two cases per 1,000 patient-years.5 This rather high incidence, coupled with escalating rates of SSTIs due to CA-MRSA, demands reliable and cost-effective treatment strategies for the management of community-acquired cellulitis.

Review of the Data

The treatment of community-acquired cellulitis was straightforward until the past decade, as physicians saw a significant increase in CA-MRSA incidence.6 MRSA was reported initially in 1961, only two years after methicillin was introduced into clinical practice.7,8 Subsequently, MRSA prevalence increased dramatically, and by the beginning of this decade, more than 50% of the Staphylococcus aureus hospital strains were resistant to methicillin.8 Furthermore, 60% to 80% of community-acquired Staphylococcus aureus strains in the U.S. are methicillin-resistant.8

The two major types of MRSA infections are healthcare-acquired (HA-MRSA) and community-acquired (CA-MRSA). The HA-MRSA infection group is further subdivided into those strains that develop during a period of hospitalization, and those that develop following contact with healthcare facilities (e.g., hospitalization or surgery within the previous year). This subgroup includes HA-MRSA infections in hemodialysis patients, residents of long-term care facilities, and individuals who have a vascular catheter or other indwelling device.9,10

 

CA-MRSA infections, on the other hand, occur in individuals who have not had any contact with healthcare facilities. Higher rates of CA-MRSA infection are observed in settings where individuals have close contact with each other, including military trainees, athletes involved in contact sports, patients age 65 and older, men who have sex with other men, and parenteral substance abusers.8,11-13 However, in view of the high prevalence of CA-MRSA in the U.S., most patients, including those without any apparent risk factors, are at risk.8

HA-MRSA has the ability to survive on inanimate objects for extended time periods, increasing the likelihood of transmission to persons who come into contact with those objects. Although evidence has not confirmed that CA-MRSA has a similar capacity, it seems plausible that such spread does contribute to the propagation of CA-MRSA.12

The increasing importance of CA-MRSA also is evident in hospital settings, where it is replacing HA-MRSA as the most common type of Staphylococcus aureus. Since CA-MRSA tends to be susceptible to a larger number of antibiotics than HA-MRSA is, this has led to a reduced incidence of multidrug resistance. Fortunately, unlike HA-MRSA, CA-MRSA is susceptible to non-beta-lactam antibiotics, including tetracyclines, sulfonamides, and clindamycin.9

CA-MRSA most often causes SSTIs, and a tender abscess is a typical presentation.8 Patients commonly misinterpret early skin lesions as an insect or spider bite.12,14 When cutaneous CA-MRSA presents as an abscess, an incision and drainage procedure is essential for adequate treatment of the infection. For some CA-MRSA infections, particularly those characterized by the presence of a relatively small abscess, it might be adequate to do only an incision and drainage procedure, and not administer antibiotics.8,15 However, in most instances, especially when there is an area of cellulitis around the abscess, the initiation of antibiotic therapy improves patients’ clinical outcomes.9,16

When there is no apparent drainable purulent fluid collection, which often occurs with cellulitis, antibiotics should be the mainstay of therapy. The decision about which antibiotic to start can present some challenges, because the organism causing the cellulitis usually is not identified. This is because blood cultures are positive in less than 5% of cases. Also, positive culture results from needle aspiration are only helpful from 5% to 40% of the time. Meanwhile, culture of punch biopsy specimens yields a pathogen in only 20% to 30% of cases.3,17-19

Due to increased CA-MRSA incidence, cephalexin should not be prescribed to treat cellulitis in the outpatient setting because it does not provide coverage for the pathogen.13 Instead, oral antibiotics (e.g., clindamycin or trimethoprim/sulfamethoxazole) should be prescribed. Doxycycline, minocycline, rifampin (usually prescribed in combination with fusidic acid to prevent resistance development), and linezolid are additional therapeutic options.

Trimethoprim/sulfamethoxazole and clindamycin have several advantages: good oral bioavailability, familiarity to physicians, and general affordability. A disadvantage to using both trimethoprim/sulfamethoxazole and doxycycline is that they provide inadequate coverage for group A streptococci, which are a common cause of cellulitis. Therefore, the simultaneous use of a beta-lactam antibiotic with either of these medications may improve outcomes for “nonpurulent” cellulitis.13,15 Linezolid has proven effective for skin and SSTI caused by MRSA, even though it is not bactericidal.

Excellent oral bioavailability of this drug is an attractive characteristic, as it facilitates the transition from the use of intravenous to oral antibiotic therapy later in a patient’s hospital course. Although oral linezolid has been studied in clinical trials and provides good coverage for MRSA, its use in the outpatient setting is relatively limited, largely due to its significant cost.20 In 2008, the cost of 10 days of treatment with oral linezolid was $1,286.80. In comparison, the generic trimethoprim/sulfamethox-azole cost $9.40, and generic clindamycin cost $95.10.8 The lack of routine availability in many outpatient pharmacies also hinders the widespread use of linezolid.13

 

To date, with the exception of linezolid, no randomized, prospective clinical trials clearly demonstrate the efficacy of the oral agents that are commonly used for the outpatient treatment of cellulitis.20

When patients require hospitalization for the optimal treatment of cellulitis, it is important to select a parenteral antibiotic that provides coverage for MRSA.8 Vancomycin, daptomycin, linezolid, and tigecycline are the most commonly used agents.6

In the inpatient setting, failure to initiate appropriate medical therapy can result in longer hospital admissions, which significantly increase inpatient costs. Inadequate antibiotic therapy creates a significant financial burden and has been associated with increased mortality.4 Historically, vancomycin is used whenever a MRSA infection is suspected. However, there is concern about the declining efficacy of vancomycin related to a gradual increase in the rate of relative resistance—a minimal inhibitory concentration (MIC) increase—in MRSA strains. This MIC creep is noted in some medical centers and can lead to a failure to respond to vancomycin.13,20

Daptomycin is rapidly bactericidal against MRSA; in some institutions, its use may be preferred over vancomycin because the former antibiotic is associated with a significantly more rapid clinical response, which may shorten the required length of hospitalization.21 The once-daily dosing requirement for daptomycin allows for ease of use in both hospital and outpatient settings, and therefore may facilitate early hospital discharge or prevent the need for hospitalization altogether. Clinical experience also suggests potential economic advantages with the use of daptomycin.22

Tigecycline is a bacteriostatic antibiotic that achieves low serum concentrations. However, it penetrates the skin well and has a similar effectiveness to combination therapy with vancomycin and aztreonam. Thus far, tigecycline is not widely used for the treatment of MRSA infections, and it has been suggested that it may be preferred for polymicrobial infections or for patients who exhibit allergies to more commonly used agents.8

When selecting an antibiotic therapy, cost considerations play an important role in the decision-making process. For intravenous agents commonly used to treat CA-MRSA infections, the 2008 cost for 10 days of treatment with generic vancomycin was $182.80; daptomycin cost $1,660.80. For tigecycline and linezolid, the same duration of treatment cost $1,362 and $1,560, respectively.8

Back to the Case

Our patient, an otherwise healthy female, presented with no apparent risk factors for developing a CA-MRSA SSTI. However, more detailed history revealed that she regularly used sports equipment at her local fitness center. Based on her clinical presentation and concerns about the high local prevalence of CA-MRSA, an incision and drainage procedure was performed, and she was started empirically on IV vancomycin. She had a positive clinical response to this treatment.

Wound culture results confirmed CA-MRSA abscess and cellulitis, susceptible to trimethoprim/sulfamethoxazole. She was discharged on the oral formulation of this antibiotic to complete a 10-day course of treatment, including the days she received intravenous antibiotics.

Few well-designed trials have compared different lengths of cellulitis therapy. Most authorities recommend five to 10 days of treatment; however, longer courses might be required for more severe or complicated diseases.

Bottom line

Because of the high prevalence of CA-MRSA, initial antibiotic therapy for the treatment of community-acquired cellulitis must provide coverage for this organism. TH

Dr. Clarke is a hospitalist and clinical instructor at Emory University School of Medicine, Atlanta. Dr. Dressler is associate professor and director of education, section of hospital medicine, and associate program director of the J. Willis Hurst Internal Medicine Residency Program. Dr. Purohit is an instructor in clinical medicine at Emory University School of Medicine.

 

References

1. Barzilai A, Choen HA. Isolation of group A streptococci from children with perianal cellulitis and from their siblings. Pediatr Infect Dis J. 1998;17(4):358-360.
2. Thorsteinsdottir B, Tleyjeh IM, Baddour LM. Abdominal wall cellulitis in the morbidly obese. Scand J Infect Dis. 2005;37(8):605-608.
3. Swartz MN. Clinical practice. Cellulitis. N Engl J Med. 2004;350(9):904-912.
4. Edelsberg J, Berger A, Weber DJ, et al. Clinical and economic consequences of failure of initial antibiotic therapy for hospitalized patients with complicated skin and skin-structure infections. Infect Control Hosp Epidemiol. 2008;29(2):160-169.
5. McNamara DR, Tleyjeh IM, Berbari EF, et al. Incidence of lower extremity cellulitis: a population-based study in Olmsted County, Minnesota. Mayo Clin Proc. 2007;82(7):817-821.
6. Moellering RC. Current treatment options for community-acquired methicillin-resistant Staphylococcus aureus infection. Clin Infect Dis. 2008;46(7):1032-1037.
7. Chambers HF. The changing epidemiology of Staphylococcus aureus. Emerg Infect Dis. 2001;7(2):178-182.
8. Moellering RC. A 39-year-old man with a skin infection. JAMA. 2008;299(1):79-87
9. Ruhe J, Smith N, Bradsher RW, Menon A. Community-onset methicillin-resistant Staphylococcus aureus skin and soft tissue infections: impact of antimicrobial therapy on outcome. Clin Infect Dis. 2007;44(6):777-784.
10. David MZ, Glikman D, Crawford SE, et al. What is community-associated methicillin-resistant Staphylococcus aureus? J Infect Dis. 2008;197(9):1235-1243.
11. Iyer S, Jones DH. Community-acquired methicillin-resistant Staphylococcus aureus skin infection: a retrospective analysis of clinical presentation and treatment of a local outbreak. J Am Acad Dermatol. 2004;50(6):854-858.
12. Centers for Disease Control and Prevention. Methicillin-resistant Staphylococcus aureus skin or soft tissue infections in a state prison—Mississippi, 2000. MMWR Morb Mortal Wkly Rep. 2001;50(42):919-922.
13. Daum RS. Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med. 2007;357(4):380-390.
14. Dominguez TJ. It’s not a spider bite, it’s community-acquired methicillin-resistant Staphylococcus aureus. J Am Board Fam Pract. 2004;17(3):220-226.
15. Moran GJ, Krishnadasan A, Gorwitz RJ, et al. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med. 2006;355(7):666-674.
16. Jetton L. Therapy for methicillin-resistant Staphylococcus aureus. N Engl J Med. 2006;355(20):2153-2155.
17. Hook EW, Hooton TM, Horton CA, et al. Microbiologic evaluation of cutaneous cellulitis in adults. Arch Intern Med. 1986;146(2):295-297.
18. Duvanel T, Auckenthaler R, Rohner P, Harms M, Saurat JH. Quantitative cultures of biopsy specimens from cutaneous cellulitis. Arch Intern Med. 1989;149(2):293-296.
19. Newell PM, Norden CW. Value of needle aspiration in bacteriologic diagnosis of cellulitis in adults. J Clin Microbiol. 1988; 26(3):401-404.
20. Loffler CA, Macdougall C. Update on prevalence and treatment of methicillin-resistant Staphylococcus aureus infections. Expert Rev Anti Infect Ther. 2007;5(6):961-981.
21. Davis SL, McKinnon PS, Hall LM, et al. Daptomycin versus vancomycin for complicated skin and skin structure infections: clinical and economic outcomes. Pharmacotherapy. 2007;27(12):1611-1618.
22. Seaton RA. Daptomycin: rationale and role in the management of skin and soft tissue infections. J Antimicrob Chemother. 2008;62(Suppl 3):iii15-23.

Case

A previously healthy 55-year-old white female presents to the ED with a three-day history of pain and erythema in her right hand. Examination reveals fluctuance as well. She is diagnosed with an abscess with surrounding cellulitis. The abscess is incised, drained, and cultured, and she is sent home on oral trimethoprim/sulfamethoxazole. The following day, her cellulitis has worsened. She is hospitalized and commenced on intravenous vancomycin. What is the best empiric therapy for community-acquired cellulitis?

Background

Cellulitis is defined as a skin and soft-tissue infection (SSTI), which develops as a result of bacterial entry via breaches in the skin barrier. Typically, it involves the dermis and subcutaneous tissue, and is associated with local tenderness, erythema, swelling and fever. Cellulitis usually affects the lower extremities, but can affect other locations resulting in diagnoses such as periorbital, abdominal wall, buccal, and perianal cellulitis.1,2

Gram-positive organisms, especially Staphylococcus aureus and beta hemolytic streptococci, are the most common causes of cellulitis. Although it is less common, cellulitis can be caused by gram-negative organisms. The recent significant increase in the prevalence of SSTIs due to community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has led to changes in the selection of antibiotics that were most commonly utilized to empirically treat cellulitis.

The diagnosis of cellulitis is based primarily on clinical manifestations. Due to low diagnostic yields, blood cultures, needle aspiration, or punch biopsy, specimens usually are not helpful in the setting of simple cellulitis.3 Therefore, antibiotic therapy is almost universally started empirically. Starting appropriate initial antibiotic therapy improves patient outcomes by reducing mortality rates, length of stay, and inpatient costs.4

Cellulitis incidence is about two cases per 1,000 patient-years.5 This rather high incidence, coupled with escalating rates of SSTIs due to CA-MRSA, demands reliable and cost-effective treatment strategies for the management of community-acquired cellulitis.

Review of the Data

The treatment of community-acquired cellulitis was straightforward until the past decade, as physicians saw a significant increase in CA-MRSA incidence.6 MRSA was reported initially in 1961, only two years after methicillin was introduced into clinical practice.7,8 Subsequently, MRSA prevalence increased dramatically, and by the beginning of this decade, more than 50% of the Staphylococcus aureus hospital strains were resistant to methicillin.8 Furthermore, 60% to 80% of community-acquired Staphylococcus aureus strains in the U.S. are methicillin-resistant.8

The two major types of MRSA infections are healthcare-acquired (HA-MRSA) and community-acquired (CA-MRSA). The HA-MRSA infection group is further subdivided into those strains that develop during a period of hospitalization, and those that develop following contact with healthcare facilities (e.g., hospitalization or surgery within the previous year). This subgroup includes HA-MRSA infections in hemodialysis patients, residents of long-term care facilities, and individuals who have a vascular catheter or other indwelling device.9,10

 

CA-MRSA infections, on the other hand, occur in individuals who have not had any contact with healthcare facilities. Higher rates of CA-MRSA infection are observed in settings where individuals have close contact with each other, including military trainees, athletes involved in contact sports, patients age 65 and older, men who have sex with other men, and parenteral substance abusers.8,11-13 However, in view of the high prevalence of CA-MRSA in the U.S., most patients, including those without any apparent risk factors, are at risk.8

HA-MRSA has the ability to survive on inanimate objects for extended time periods, increasing the likelihood of transmission to persons who come into contact with those objects. Although evidence has not confirmed that CA-MRSA has a similar capacity, it seems plausible that such spread does contribute to the propagation of CA-MRSA.12

The increasing importance of CA-MRSA also is evident in hospital settings, where it is replacing HA-MRSA as the most common type of Staphylococcus aureus. Since CA-MRSA tends to be susceptible to a larger number of antibiotics than HA-MRSA is, this has led to a reduced incidence of multidrug resistance. Fortunately, unlike HA-MRSA, CA-MRSA is susceptible to non-beta-lactam antibiotics, including tetracyclines, sulfonamides, and clindamycin.9

CA-MRSA most often causes SSTIs, and a tender abscess is a typical presentation.8 Patients commonly misinterpret early skin lesions as an insect or spider bite.12,14 When cutaneous CA-MRSA presents as an abscess, an incision and drainage procedure is essential for adequate treatment of the infection. For some CA-MRSA infections, particularly those characterized by the presence of a relatively small abscess, it might be adequate to do only an incision and drainage procedure, and not administer antibiotics.8,15 However, in most instances, especially when there is an area of cellulitis around the abscess, the initiation of antibiotic therapy improves patients’ clinical outcomes.9,16

When there is no apparent drainable purulent fluid collection, which often occurs with cellulitis, antibiotics should be the mainstay of therapy. The decision about which antibiotic to start can present some challenges, because the organism causing the cellulitis usually is not identified. This is because blood cultures are positive in less than 5% of cases. Also, positive culture results from needle aspiration are only helpful from 5% to 40% of the time. Meanwhile, culture of punch biopsy specimens yields a pathogen in only 20% to 30% of cases.3,17-19

Due to increased CA-MRSA incidence, cephalexin should not be prescribed to treat cellulitis in the outpatient setting because it does not provide coverage for the pathogen.13 Instead, oral antibiotics (e.g., clindamycin or trimethoprim/sulfamethoxazole) should be prescribed. Doxycycline, minocycline, rifampin (usually prescribed in combination with fusidic acid to prevent resistance development), and linezolid are additional therapeutic options.

Trimethoprim/sulfamethoxazole and clindamycin have several advantages: good oral bioavailability, familiarity to physicians, and general affordability. A disadvantage to using both trimethoprim/sulfamethoxazole and doxycycline is that they provide inadequate coverage for group A streptococci, which are a common cause of cellulitis. Therefore, the simultaneous use of a beta-lactam antibiotic with either of these medications may improve outcomes for “nonpurulent” cellulitis.13,15 Linezolid has proven effective for skin and SSTI caused by MRSA, even though it is not bactericidal.

Excellent oral bioavailability of this drug is an attractive characteristic, as it facilitates the transition from the use of intravenous to oral antibiotic therapy later in a patient’s hospital course. Although oral linezolid has been studied in clinical trials and provides good coverage for MRSA, its use in the outpatient setting is relatively limited, largely due to its significant cost.20 In 2008, the cost of 10 days of treatment with oral linezolid was $1,286.80. In comparison, the generic trimethoprim/sulfamethox-azole cost $9.40, and generic clindamycin cost $95.10.8 The lack of routine availability in many outpatient pharmacies also hinders the widespread use of linezolid.13

 

To date, with the exception of linezolid, no randomized, prospective clinical trials clearly demonstrate the efficacy of the oral agents that are commonly used for the outpatient treatment of cellulitis.20

When patients require hospitalization for the optimal treatment of cellulitis, it is important to select a parenteral antibiotic that provides coverage for MRSA.8 Vancomycin, daptomycin, linezolid, and tigecycline are the most commonly used agents.6

In the inpatient setting, failure to initiate appropriate medical therapy can result in longer hospital admissions, which significantly increase inpatient costs. Inadequate antibiotic therapy creates a significant financial burden and has been associated with increased mortality.4 Historically, vancomycin is used whenever a MRSA infection is suspected. However, there is concern about the declining efficacy of vancomycin related to a gradual increase in the rate of relative resistance—a minimal inhibitory concentration (MIC) increase—in MRSA strains. This MIC creep is noted in some medical centers and can lead to a failure to respond to vancomycin.13,20

Daptomycin is rapidly bactericidal against MRSA; in some institutions, its use may be preferred over vancomycin because the former antibiotic is associated with a significantly more rapid clinical response, which may shorten the required length of hospitalization.21 The once-daily dosing requirement for daptomycin allows for ease of use in both hospital and outpatient settings, and therefore may facilitate early hospital discharge or prevent the need for hospitalization altogether. Clinical experience also suggests potential economic advantages with the use of daptomycin.22

Tigecycline is a bacteriostatic antibiotic that achieves low serum concentrations. However, it penetrates the skin well and has a similar effectiveness to combination therapy with vancomycin and aztreonam. Thus far, tigecycline is not widely used for the treatment of MRSA infections, and it has been suggested that it may be preferred for polymicrobial infections or for patients who exhibit allergies to more commonly used agents.8

When selecting an antibiotic therapy, cost considerations play an important role in the decision-making process. For intravenous agents commonly used to treat CA-MRSA infections, the 2008 cost for 10 days of treatment with generic vancomycin was $182.80; daptomycin cost $1,660.80. For tigecycline and linezolid, the same duration of treatment cost $1,362 and $1,560, respectively.8

Back to the Case

Our patient, an otherwise healthy female, presented with no apparent risk factors for developing a CA-MRSA SSTI. However, more detailed history revealed that she regularly used sports equipment at her local fitness center. Based on her clinical presentation and concerns about the high local prevalence of CA-MRSA, an incision and drainage procedure was performed, and she was started empirically on IV vancomycin. She had a positive clinical response to this treatment.

Wound culture results confirmed CA-MRSA abscess and cellulitis, susceptible to trimethoprim/sulfamethoxazole. She was discharged on the oral formulation of this antibiotic to complete a 10-day course of treatment, including the days she received intravenous antibiotics.

Few well-designed trials have compared different lengths of cellulitis therapy. Most authorities recommend five to 10 days of treatment; however, longer courses might be required for more severe or complicated diseases.

Bottom line

Because of the high prevalence of CA-MRSA, initial antibiotic therapy for the treatment of community-acquired cellulitis must provide coverage for this organism. TH

Dr. Clarke is a hospitalist and clinical instructor at Emory University School of Medicine, Atlanta. Dr. Dressler is associate professor and director of education, section of hospital medicine, and associate program director of the J. Willis Hurst Internal Medicine Residency Program. Dr. Purohit is an instructor in clinical medicine at Emory University School of Medicine.

 

References

1. Barzilai A, Choen HA. Isolation of group A streptococci from children with perianal cellulitis and from their siblings. Pediatr Infect Dis J. 1998;17(4):358-360.
2. Thorsteinsdottir B, Tleyjeh IM, Baddour LM. Abdominal wall cellulitis in the morbidly obese. Scand J Infect Dis. 2005;37(8):605-608.
3. Swartz MN. Clinical practice. Cellulitis. N Engl J Med. 2004;350(9):904-912.
4. Edelsberg J, Berger A, Weber DJ, et al. Clinical and economic consequences of failure of initial antibiotic therapy for hospitalized patients with complicated skin and skin-structure infections. Infect Control Hosp Epidemiol. 2008;29(2):160-169.
5. McNamara DR, Tleyjeh IM, Berbari EF, et al. Incidence of lower extremity cellulitis: a population-based study in Olmsted County, Minnesota. Mayo Clin Proc. 2007;82(7):817-821.
6. Moellering RC. Current treatment options for community-acquired methicillin-resistant Staphylococcus aureus infection. Clin Infect Dis. 2008;46(7):1032-1037.
7. Chambers HF. The changing epidemiology of Staphylococcus aureus. Emerg Infect Dis. 2001;7(2):178-182.
8. Moellering RC. A 39-year-old man with a skin infection. JAMA. 2008;299(1):79-87
9. Ruhe J, Smith N, Bradsher RW, Menon A. Community-onset methicillin-resistant Staphylococcus aureus skin and soft tissue infections: impact of antimicrobial therapy on outcome. Clin Infect Dis. 2007;44(6):777-784.
10. David MZ, Glikman D, Crawford SE, et al. What is community-associated methicillin-resistant Staphylococcus aureus? J Infect Dis. 2008;197(9):1235-1243.
11. Iyer S, Jones DH. Community-acquired methicillin-resistant Staphylococcus aureus skin infection: a retrospective analysis of clinical presentation and treatment of a local outbreak. J Am Acad Dermatol. 2004;50(6):854-858.
12. Centers for Disease Control and Prevention. Methicillin-resistant Staphylococcus aureus skin or soft tissue infections in a state prison—Mississippi, 2000. MMWR Morb Mortal Wkly Rep. 2001;50(42):919-922.
13. Daum RS. Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med. 2007;357(4):380-390.
14. Dominguez TJ. It’s not a spider bite, it’s community-acquired methicillin-resistant Staphylococcus aureus. J Am Board Fam Pract. 2004;17(3):220-226.
15. Moran GJ, Krishnadasan A, Gorwitz RJ, et al. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med. 2006;355(7):666-674.
16. Jetton L. Therapy for methicillin-resistant Staphylococcus aureus. N Engl J Med. 2006;355(20):2153-2155.
17. Hook EW, Hooton TM, Horton CA, et al. Microbiologic evaluation of cutaneous cellulitis in adults. Arch Intern Med. 1986;146(2):295-297.
18. Duvanel T, Auckenthaler R, Rohner P, Harms M, Saurat JH. Quantitative cultures of biopsy specimens from cutaneous cellulitis. Arch Intern Med. 1989;149(2):293-296.
19. Newell PM, Norden CW. Value of needle aspiration in bacteriologic diagnosis of cellulitis in adults. J Clin Microbiol. 1988; 26(3):401-404.
20. Loffler CA, Macdougall C. Update on prevalence and treatment of methicillin-resistant Staphylococcus aureus infections. Expert Rev Anti Infect Ther. 2007;5(6):961-981.
21. Davis SL, McKinnon PS, Hall LM, et al. Daptomycin versus vancomycin for complicated skin and skin structure infections: clinical and economic outcomes. Pharmacotherapy. 2007;27(12):1611-1618.
22. Seaton RA. Daptomycin: rationale and role in the management of skin and soft tissue infections. J Antimicrob Chemother. 2008;62(Suppl 3):iii15-23.

Case

A previously healthy 55-year-old white female presents to the ED with a three-day history of pain and erythema in her right hand. Examination reveals fluctuance as well. She is diagnosed with an abscess with surrounding cellulitis. The abscess is incised, drained, and cultured, and she is sent home on oral trimethoprim/sulfamethoxazole. The following day, her cellulitis has worsened. She is hospitalized and commenced on intravenous vancomycin. What is the best empiric therapy for community-acquired cellulitis?

Background

Cellulitis is defined as a skin and soft-tissue infection (SSTI), which develops as a result of bacterial entry via breaches in the skin barrier. Typically, it involves the dermis and subcutaneous tissue, and is associated with local tenderness, erythema, swelling and fever. Cellulitis usually affects the lower extremities, but can affect other locations resulting in diagnoses such as periorbital, abdominal wall, buccal, and perianal cellulitis.1,2

Gram-positive organisms, especially Staphylococcus aureus and beta hemolytic streptococci, are the most common causes of cellulitis. Although it is less common, cellulitis can be caused by gram-negative organisms. The recent significant increase in the prevalence of SSTIs due to community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has led to changes in the selection of antibiotics that were most commonly utilized to empirically treat cellulitis.

The diagnosis of cellulitis is based primarily on clinical manifestations. Due to low diagnostic yields, blood cultures, needle aspiration, or punch biopsy, specimens usually are not helpful in the setting of simple cellulitis.3 Therefore, antibiotic therapy is almost universally started empirically. Starting appropriate initial antibiotic therapy improves patient outcomes by reducing mortality rates, length of stay, and inpatient costs.4

Cellulitis incidence is about two cases per 1,000 patient-years.5 This rather high incidence, coupled with escalating rates of SSTIs due to CA-MRSA, demands reliable and cost-effective treatment strategies for the management of community-acquired cellulitis.

Review of the Data

The treatment of community-acquired cellulitis was straightforward until the past decade, as physicians saw a significant increase in CA-MRSA incidence.6 MRSA was reported initially in 1961, only two years after methicillin was introduced into clinical practice.7,8 Subsequently, MRSA prevalence increased dramatically, and by the beginning of this decade, more than 50% of the Staphylococcus aureus hospital strains were resistant to methicillin.8 Furthermore, 60% to 80% of community-acquired Staphylococcus aureus strains in the U.S. are methicillin-resistant.8

The two major types of MRSA infections are healthcare-acquired (HA-MRSA) and community-acquired (CA-MRSA). The HA-MRSA infection group is further subdivided into those strains that develop during a period of hospitalization, and those that develop following contact with healthcare facilities (e.g., hospitalization or surgery within the previous year). This subgroup includes HA-MRSA infections in hemodialysis patients, residents of long-term care facilities, and individuals who have a vascular catheter or other indwelling device.9,10

 

CA-MRSA infections, on the other hand, occur in individuals who have not had any contact with healthcare facilities. Higher rates of CA-MRSA infection are observed in settings where individuals have close contact with each other, including military trainees, athletes involved in contact sports, patients age 65 and older, men who have sex with other men, and parenteral substance abusers.8,11-13 However, in view of the high prevalence of CA-MRSA in the U.S., most patients, including those without any apparent risk factors, are at risk.8

HA-MRSA has the ability to survive on inanimate objects for extended time periods, increasing the likelihood of transmission to persons who come into contact with those objects. Although evidence has not confirmed that CA-MRSA has a similar capacity, it seems plausible that such spread does contribute to the propagation of CA-MRSA.12

The increasing importance of CA-MRSA also is evident in hospital settings, where it is replacing HA-MRSA as the most common type of Staphylococcus aureus. Since CA-MRSA tends to be susceptible to a larger number of antibiotics than HA-MRSA is, this has led to a reduced incidence of multidrug resistance. Fortunately, unlike HA-MRSA, CA-MRSA is susceptible to non-beta-lactam antibiotics, including tetracyclines, sulfonamides, and clindamycin.9

CA-MRSA most often causes SSTIs, and a tender abscess is a typical presentation.8 Patients commonly misinterpret early skin lesions as an insect or spider bite.12,14 When cutaneous CA-MRSA presents as an abscess, an incision and drainage procedure is essential for adequate treatment of the infection. For some CA-MRSA infections, particularly those characterized by the presence of a relatively small abscess, it might be adequate to do only an incision and drainage procedure, and not administer antibiotics.8,15 However, in most instances, especially when there is an area of cellulitis around the abscess, the initiation of antibiotic therapy improves patients’ clinical outcomes.9,16

When there is no apparent drainable purulent fluid collection, which often occurs with cellulitis, antibiotics should be the mainstay of therapy. The decision about which antibiotic to start can present some challenges, because the organism causing the cellulitis usually is not identified. This is because blood cultures are positive in less than 5% of cases. Also, positive culture results from needle aspiration are only helpful from 5% to 40% of the time. Meanwhile, culture of punch biopsy specimens yields a pathogen in only 20% to 30% of cases.3,17-19

Due to increased CA-MRSA incidence, cephalexin should not be prescribed to treat cellulitis in the outpatient setting because it does not provide coverage for the pathogen.13 Instead, oral antibiotics (e.g., clindamycin or trimethoprim/sulfamethoxazole) should be prescribed. Doxycycline, minocycline, rifampin (usually prescribed in combination with fusidic acid to prevent resistance development), and linezolid are additional therapeutic options.

Trimethoprim/sulfamethoxazole and clindamycin have several advantages: good oral bioavailability, familiarity to physicians, and general affordability. A disadvantage to using both trimethoprim/sulfamethoxazole and doxycycline is that they provide inadequate coverage for group A streptococci, which are a common cause of cellulitis. Therefore, the simultaneous use of a beta-lactam antibiotic with either of these medications may improve outcomes for “nonpurulent” cellulitis.13,15 Linezolid has proven effective for skin and SSTI caused by MRSA, even though it is not bactericidal.

Excellent oral bioavailability of this drug is an attractive characteristic, as it facilitates the transition from the use of intravenous to oral antibiotic therapy later in a patient’s hospital course. Although oral linezolid has been studied in clinical trials and provides good coverage for MRSA, its use in the outpatient setting is relatively limited, largely due to its significant cost.20 In 2008, the cost of 10 days of treatment with oral linezolid was $1,286.80. In comparison, the generic trimethoprim/sulfamethox-azole cost $9.40, and generic clindamycin cost $95.10.8 The lack of routine availability in many outpatient pharmacies also hinders the widespread use of linezolid.13

 

To date, with the exception of linezolid, no randomized, prospective clinical trials clearly demonstrate the efficacy of the oral agents that are commonly used for the outpatient treatment of cellulitis.20

When patients require hospitalization for the optimal treatment of cellulitis, it is important to select a parenteral antibiotic that provides coverage for MRSA.8 Vancomycin, daptomycin, linezolid, and tigecycline are the most commonly used agents.6

In the inpatient setting, failure to initiate appropriate medical therapy can result in longer hospital admissions, which significantly increase inpatient costs. Inadequate antibiotic therapy creates a significant financial burden and has been associated with increased mortality.4 Historically, vancomycin is used whenever a MRSA infection is suspected. However, there is concern about the declining efficacy of vancomycin related to a gradual increase in the rate of relative resistance—a minimal inhibitory concentration (MIC) increase—in MRSA strains. This MIC creep is noted in some medical centers and can lead to a failure to respond to vancomycin.13,20

Daptomycin is rapidly bactericidal against MRSA; in some institutions, its use may be preferred over vancomycin because the former antibiotic is associated with a significantly more rapid clinical response, which may shorten the required length of hospitalization.21 The once-daily dosing requirement for daptomycin allows for ease of use in both hospital and outpatient settings, and therefore may facilitate early hospital discharge or prevent the need for hospitalization altogether. Clinical experience also suggests potential economic advantages with the use of daptomycin.22

Tigecycline is a bacteriostatic antibiotic that achieves low serum concentrations. However, it penetrates the skin well and has a similar effectiveness to combination therapy with vancomycin and aztreonam. Thus far, tigecycline is not widely used for the treatment of MRSA infections, and it has been suggested that it may be preferred for polymicrobial infections or for patients who exhibit allergies to more commonly used agents.8

When selecting an antibiotic therapy, cost considerations play an important role in the decision-making process. For intravenous agents commonly used to treat CA-MRSA infections, the 2008 cost for 10 days of treatment with generic vancomycin was $182.80; daptomycin cost $1,660.80. For tigecycline and linezolid, the same duration of treatment cost $1,362 and $1,560, respectively.8

Back to the Case

Our patient, an otherwise healthy female, presented with no apparent risk factors for developing a CA-MRSA SSTI. However, more detailed history revealed that she regularly used sports equipment at her local fitness center. Based on her clinical presentation and concerns about the high local prevalence of CA-MRSA, an incision and drainage procedure was performed, and she was started empirically on IV vancomycin. She had a positive clinical response to this treatment.

Wound culture results confirmed CA-MRSA abscess and cellulitis, susceptible to trimethoprim/sulfamethoxazole. She was discharged on the oral formulation of this antibiotic to complete a 10-day course of treatment, including the days she received intravenous antibiotics.

Few well-designed trials have compared different lengths of cellulitis therapy. Most authorities recommend five to 10 days of treatment; however, longer courses might be required for more severe or complicated diseases.

Bottom line

Because of the high prevalence of CA-MRSA, initial antibiotic therapy for the treatment of community-acquired cellulitis must provide coverage for this organism. TH

Dr. Clarke is a hospitalist and clinical instructor at Emory University School of Medicine, Atlanta. Dr. Dressler is associate professor and director of education, section of hospital medicine, and associate program director of the J. Willis Hurst Internal Medicine Residency Program. Dr. Purohit is an instructor in clinical medicine at Emory University School of Medicine.

 

References

1. Barzilai A, Choen HA. Isolation of group A streptococci from children with perianal cellulitis and from their siblings. Pediatr Infect Dis J. 1998;17(4):358-360.
2. Thorsteinsdottir B, Tleyjeh IM, Baddour LM. Abdominal wall cellulitis in the morbidly obese. Scand J Infect Dis. 2005;37(8):605-608.
3. Swartz MN. Clinical practice. Cellulitis. N Engl J Med. 2004;350(9):904-912.
4. Edelsberg J, Berger A, Weber DJ, et al. Clinical and economic consequences of failure of initial antibiotic therapy for hospitalized patients with complicated skin and skin-structure infections. Infect Control Hosp Epidemiol. 2008;29(2):160-169.
5. McNamara DR, Tleyjeh IM, Berbari EF, et al. Incidence of lower extremity cellulitis: a population-based study in Olmsted County, Minnesota. Mayo Clin Proc. 2007;82(7):817-821.
6. Moellering RC. Current treatment options for community-acquired methicillin-resistant Staphylococcus aureus infection. Clin Infect Dis. 2008;46(7):1032-1037.
7. Chambers HF. The changing epidemiology of Staphylococcus aureus. Emerg Infect Dis. 2001;7(2):178-182.
8. Moellering RC. A 39-year-old man with a skin infection. JAMA. 2008;299(1):79-87
9. Ruhe J, Smith N, Bradsher RW, Menon A. Community-onset methicillin-resistant Staphylococcus aureus skin and soft tissue infections: impact of antimicrobial therapy on outcome. Clin Infect Dis. 2007;44(6):777-784.
10. David MZ, Glikman D, Crawford SE, et al. What is community-associated methicillin-resistant Staphylococcus aureus? J Infect Dis. 2008;197(9):1235-1243.
11. Iyer S, Jones DH. Community-acquired methicillin-resistant Staphylococcus aureus skin infection: a retrospective analysis of clinical presentation and treatment of a local outbreak. J Am Acad Dermatol. 2004;50(6):854-858.
12. Centers for Disease Control and Prevention. Methicillin-resistant Staphylococcus aureus skin or soft tissue infections in a state prison—Mississippi, 2000. MMWR Morb Mortal Wkly Rep. 2001;50(42):919-922.
13. Daum RS. Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med. 2007;357(4):380-390.
14. Dominguez TJ. It’s not a spider bite, it’s community-acquired methicillin-resistant Staphylococcus aureus. J Am Board Fam Pract. 2004;17(3):220-226.
15. Moran GJ, Krishnadasan A, Gorwitz RJ, et al. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med. 2006;355(7):666-674.
16. Jetton L. Therapy for methicillin-resistant Staphylococcus aureus. N Engl J Med. 2006;355(20):2153-2155.
17. Hook EW, Hooton TM, Horton CA, et al. Microbiologic evaluation of cutaneous cellulitis in adults. Arch Intern Med. 1986;146(2):295-297.
18. Duvanel T, Auckenthaler R, Rohner P, Harms M, Saurat JH. Quantitative cultures of biopsy specimens from cutaneous cellulitis. Arch Intern Med. 1989;149(2):293-296.
19. Newell PM, Norden CW. Value of needle aspiration in bacteriologic diagnosis of cellulitis in adults. J Clin Microbiol. 1988; 26(3):401-404.
20. Loffler CA, Macdougall C. Update on prevalence and treatment of methicillin-resistant Staphylococcus aureus infections. Expert Rev Anti Infect Ther. 2007;5(6):961-981.
21. Davis SL, McKinnon PS, Hall LM, et al. Daptomycin versus vancomycin for complicated skin and skin structure infections: clinical and economic outcomes. Pharmacotherapy. 2007;27(12):1611-1618.
22. Seaton RA. Daptomycin: rationale and role in the management of skin and soft tissue infections. J Antimicrob Chemother. 2008;62(Suppl 3):iii15-23.

According to the American Diabetes Association, a normal fasting plasma glucose (FPG) level is less than 100 mg/dl; impaired fasting glucose (IFG) is defined as an FPG from 100 to 125 mg/dl; and any patient with an FPG greater than or equal to 126 mg/dL carries a provisional diagnosis of diabetes.1 When the oral glucose tolerance test is used for evaluation, similar definitions exist. Patients with IFG or impaired glucose tolerance (IGT) have “pre-diabetes,” and are at a high risk for developing diabetes. Elevated blood glucose levels can have major consequences, particularly in high-risk populations.2

 

Macrovascular and microvascular complications, impaired wound healing, and a compromised immune system can occur in the setting of sustained, elevated blood glucose concentrations. Aside from patients with diabetes who have elevated blood glucose levels, schizophrenic patients might be predisposed to glucose intolerance and diabetes independent of treatment.3

It is not known whether IGT seen in schizophrenics is due to lifestyle risk factors (e.g., smoking, poor diet, being overweight, lack of exercise) or some genetic or biological component of the disease. However, this is complicated by the fact that many of these patients are treated with second-generation antipsychotics (SGAs), which might increase the risk of developing diabetes.4 Because of this, a warning regarding the risk of developing hyperglycemia and diabetes was mandated by the Food and Drug Administration (FDA) for SGA manufacturers.5

Hyperglycemia symptoms include polyuria, polydipsia, weight loss (sometimes with polyphagia), and blurred vision. Impairment of growth and susceptibility to certain infections might occur with chronic hyperglycemia. Hyperglycemia with ketoacidosis or the nonketotic hyperosmolar syndrome are acute, life-threatening consequences of uncontrolled diabetes. It is important for hospitalists and other healthcare professionals to be aware of drugs that can cause hyperglycemia or impair glucose tolerance. In some cases, the drug can be continued; in other cases, an alternate agent should be provided if necessary for patient management.

Certain drugs and drug classes known to cause hyperglycemia include: thiazide diuretics, glucocorticoids, oral contraceptives and sex hormones (e.g., testosterone), protease inhibitors, SGAs, thyroid hormone, phenytoin, niacin/nicotinic acid, diazoxide, and alfa-interferon.1-3,6

Limited evidence exists for some other agents/classes, including: asparaginase, beta-agonists, beta-blockers, calcium channel blockers, clonidine, cyclosporine, levodopa, lithium, minoxidil, phenothiazines, and others.7 The Seventh Report of the Joint National Committee (JNC 7) recommends thiazide diuretics as a first-line treatment for most patients with Stage 1 hypertension, alone or in combination for patients with diabetes.8 These thiazide doses tend to be smaller and, therefore, tend to have minimal effects on blood glucose levels.

In 2004, a consensus guideline was developed on antipsychotic drugs, obesity, and diabetes.9 It describes baseline and followup monitoring of patients treated with SGAs. The baseline includes personal/family history, weight/body mass index, waist circumference, blood pressure, FPG, and a fasting lipid profile. Monitoring of these parameters is then designated at specified times throughout treatment (e.g., weeks four, eight, 12, etc.). Haupt et al recently compared monitoring of lipids and glucose in a population of insured patients receiving SGAs in a retrospective cohort of patients pre- and post-guideline.10 Baseline lipid and glucose testing rates increased minimally post-guideline versus pre-guideline.

The results of this study demonstrate that even though monitoring guidelines to prevent potentially adverse outcomes in a patient population at high risk for developing adverse outcomes are available, clinicians do not always follow them. In order to improve patient outcomes, identified at-risk populations (e.g., patients receiving SGAs) need to be more closely evaluated and monitored throughout therapy to prevent IGT and/or diabetes. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2009;32:S62-S67.
2. Luna B, Feinglos MN. Drug-induced hyperglycemia. JAMA. 2001;286:1945-1948.
3. Newcomer JW. Metabolic considerations in the use of antipsychotic medications: a review of recent evidence. J Clin Psychiatry. 2007;68(Suppl 1):20-27.
4. Tahir R. Metabolic effects of atypical antipsychotics. US Pharm. 2007;32:HS3-HS14.
5. Warning about hyperglycemia and atypical antipsychotic drugs. U.S. Food & Drug Administration Web site. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=229. Accessed March 31, 2009.
6. Kaufman MB, Simionatto C. A review of protease inhibitor-induced hyperglycemia. Pharmacotherapy. 1999;19:114-117.
7. Pandit MK, Burke J, Gustafson AB, Minocha A, Peiris AN. Drug-induced disorders of glucose tolerance. Ann Intern Med. 1993;118:529-539.
8. Chobanian AV, Bakris GL, Clack HR, et al. The seventh report of the joint national committee on prevention, detection, evaluations, and treatment of high blood pressure. JAMA. 2003;289:2560-2572.
9. American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27:596-601.
10. Haupt DW, Rosenblatt LC, Kim E, Baker RA, Whitehead R, Newcomer JW. Prevalence and predictors of lipid and glucose monitoring in commercially insured patients treated with second-generation antipsychotic agents. Am J Psychiatry. 2009;166:345-353.
11. FDA approves generic treatment for emesis. Drug Store News Web site. Available at: www.drugstorenews.com/story.aspx?id=96143. Accessed March 6, 2009.
12. Aurobindo Pharma gets tentative approval from US FDA for tenofovir disoproxil fumarate tabs. RTT News Web site. Available at: www.rttnews.com/ArticleView.aspx?id=860423. Accessed March 4, 2009.
13. Teva announces approval and launch of generic Topamax tablets.Teva Web site. Available at: www.tevapharm.com/pr/2009/pr_835.asp. Accessed March 30, 2009.
14. FDA approves Symbicort for chronic obstructive pulmonary disease (COPD). AstraZeneca Web site. Available at: www.astrazeneca-us.com/about-astrazenecaus/newsroom/all/4939997?itemId=4939997. Accessed June 5, 2009.
15. Copaxone approved by the FDA for patients with a first clinical event suggestive of multiple sclerosis. Teva Web site. Available at: www.tevapharm.com/pr/2009/ pr_826.asp? Accessed June 5, 2009.
16. Todoruk M. FDA approves new use for Wyeth’s Tygacil antibiotic. Available at: www.firstwordplus.com/Fws.do?articleid=CF71DE6056CE4120A295243AE2D6EC00. Accessed March 25, 2009.
17. FDA Web site. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf. Accessed June 5, 2009.
18. Transdermal drug patches with metallic backings. FDA Web site. Available at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm111493.htm. Accessed June 5, 2009.
19. FDA warns about risk of wearing medicated patches during MRIs. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149537.htm. Accessed March 6, 2009.
20. FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149533.htm. Accessed March 4, 2009.
21. Zonisamide (marketed as Zonegran, and generics). FDA Web site. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm095251.htm. Accessed March 4, 2009.

According to the American Diabetes Association, a normal fasting plasma glucose (FPG) level is less than 100 mg/dl; impaired fasting glucose (IFG) is defined as an FPG from 100 to 125 mg/dl; and any patient with an FPG greater than or equal to 126 mg/dL carries a provisional diagnosis of diabetes.1 When the oral glucose tolerance test is used for evaluation, similar definitions exist. Patients with IFG or impaired glucose tolerance (IGT) have “pre-diabetes,” and are at a high risk for developing diabetes. Elevated blood glucose levels can have major consequences, particularly in high-risk populations.2

 

Macrovascular and microvascular complications, impaired wound healing, and a compromised immune system can occur in the setting of sustained, elevated blood glucose concentrations. Aside from patients with diabetes who have elevated blood glucose levels, schizophrenic patients might be predisposed to glucose intolerance and diabetes independent of treatment.3

It is not known whether IGT seen in schizophrenics is due to lifestyle risk factors (e.g., smoking, poor diet, being overweight, lack of exercise) or some genetic or biological component of the disease. However, this is complicated by the fact that many of these patients are treated with second-generation antipsychotics (SGAs), which might increase the risk of developing diabetes.4 Because of this, a warning regarding the risk of developing hyperglycemia and diabetes was mandated by the Food and Drug Administration (FDA) for SGA manufacturers.5

Hyperglycemia symptoms include polyuria, polydipsia, weight loss (sometimes with polyphagia), and blurred vision. Impairment of growth and susceptibility to certain infections might occur with chronic hyperglycemia. Hyperglycemia with ketoacidosis or the nonketotic hyperosmolar syndrome are acute, life-threatening consequences of uncontrolled diabetes. It is important for hospitalists and other healthcare professionals to be aware of drugs that can cause hyperglycemia or impair glucose tolerance. In some cases, the drug can be continued; in other cases, an alternate agent should be provided if necessary for patient management.

Certain drugs and drug classes known to cause hyperglycemia include: thiazide diuretics, glucocorticoids, oral contraceptives and sex hormones (e.g., testosterone), protease inhibitors, SGAs, thyroid hormone, phenytoin, niacin/nicotinic acid, diazoxide, and alfa-interferon.1-3,6

Limited evidence exists for some other agents/classes, including: asparaginase, beta-agonists, beta-blockers, calcium channel blockers, clonidine, cyclosporine, levodopa, lithium, minoxidil, phenothiazines, and others.7 The Seventh Report of the Joint National Committee (JNC 7) recommends thiazide diuretics as a first-line treatment for most patients with Stage 1 hypertension, alone or in combination for patients with diabetes.8 These thiazide doses tend to be smaller and, therefore, tend to have minimal effects on blood glucose levels.

In 2004, a consensus guideline was developed on antipsychotic drugs, obesity, and diabetes.9 It describes baseline and followup monitoring of patients treated with SGAs. The baseline includes personal/family history, weight/body mass index, waist circumference, blood pressure, FPG, and a fasting lipid profile. Monitoring of these parameters is then designated at specified times throughout treatment (e.g., weeks four, eight, 12, etc.). Haupt et al recently compared monitoring of lipids and glucose in a population of insured patients receiving SGAs in a retrospective cohort of patients pre- and post-guideline.10 Baseline lipid and glucose testing rates increased minimally post-guideline versus pre-guideline.

The results of this study demonstrate that even though monitoring guidelines to prevent potentially adverse outcomes in a patient population at high risk for developing adverse outcomes are available, clinicians do not always follow them. In order to improve patient outcomes, identified at-risk populations (e.g., patients receiving SGAs) need to be more closely evaluated and monitored throughout therapy to prevent IGT and/or diabetes. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2009;32:S62-S67.
2. Luna B, Feinglos MN. Drug-induced hyperglycemia. JAMA. 2001;286:1945-1948.
3. Newcomer JW. Metabolic considerations in the use of antipsychotic medications: a review of recent evidence. J Clin Psychiatry. 2007;68(Suppl 1):20-27.
4. Tahir R. Metabolic effects of atypical antipsychotics. US Pharm. 2007;32:HS3-HS14.
5. Warning about hyperglycemia and atypical antipsychotic drugs. U.S. Food & Drug Administration Web site. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=229. Accessed March 31, 2009.
6. Kaufman MB, Simionatto C. A review of protease inhibitor-induced hyperglycemia. Pharmacotherapy. 1999;19:114-117.
7. Pandit MK, Burke J, Gustafson AB, Minocha A, Peiris AN. Drug-induced disorders of glucose tolerance. Ann Intern Med. 1993;118:529-539.
8. Chobanian AV, Bakris GL, Clack HR, et al. The seventh report of the joint national committee on prevention, detection, evaluations, and treatment of high blood pressure. JAMA. 2003;289:2560-2572.
9. American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27:596-601.
10. Haupt DW, Rosenblatt LC, Kim E, Baker RA, Whitehead R, Newcomer JW. Prevalence and predictors of lipid and glucose monitoring in commercially insured patients treated with second-generation antipsychotic agents. Am J Psychiatry. 2009;166:345-353.
11. FDA approves generic treatment for emesis. Drug Store News Web site. Available at: www.drugstorenews.com/story.aspx?id=96143. Accessed March 6, 2009.
12. Aurobindo Pharma gets tentative approval from US FDA for tenofovir disoproxil fumarate tabs. RTT News Web site. Available at: www.rttnews.com/ArticleView.aspx?id=860423. Accessed March 4, 2009.
13. Teva announces approval and launch of generic Topamax tablets.Teva Web site. Available at: www.tevapharm.com/pr/2009/pr_835.asp. Accessed March 30, 2009.
14. FDA approves Symbicort for chronic obstructive pulmonary disease (COPD). AstraZeneca Web site. Available at: www.astrazeneca-us.com/about-astrazenecaus/newsroom/all/4939997?itemId=4939997. Accessed June 5, 2009.
15. Copaxone approved by the FDA for patients with a first clinical event suggestive of multiple sclerosis. Teva Web site. Available at: www.tevapharm.com/pr/2009/ pr_826.asp? Accessed June 5, 2009.
16. Todoruk M. FDA approves new use for Wyeth’s Tygacil antibiotic. Available at: www.firstwordplus.com/Fws.do?articleid=CF71DE6056CE4120A295243AE2D6EC00. Accessed March 25, 2009.
17. FDA Web site. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf. Accessed June 5, 2009.
18. Transdermal drug patches with metallic backings. FDA Web site. Available at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm111493.htm. Accessed June 5, 2009.
19. FDA warns about risk of wearing medicated patches during MRIs. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149537.htm. Accessed March 6, 2009.
20. FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149533.htm. Accessed March 4, 2009.
21. Zonisamide (marketed as Zonegran, and generics). FDA Web site. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm095251.htm. Accessed March 4, 2009.

According to the American Diabetes Association, a normal fasting plasma glucose (FPG) level is less than 100 mg/dl; impaired fasting glucose (IFG) is defined as an FPG from 100 to 125 mg/dl; and any patient with an FPG greater than or equal to 126 mg/dL carries a provisional diagnosis of diabetes.1 When the oral glucose tolerance test is used for evaluation, similar definitions exist. Patients with IFG or impaired glucose tolerance (IGT) have “pre-diabetes,” and are at a high risk for developing diabetes. Elevated blood glucose levels can have major consequences, particularly in high-risk populations.2

 

Macrovascular and microvascular complications, impaired wound healing, and a compromised immune system can occur in the setting of sustained, elevated blood glucose concentrations. Aside from patients with diabetes who have elevated blood glucose levels, schizophrenic patients might be predisposed to glucose intolerance and diabetes independent of treatment.3

It is not known whether IGT seen in schizophrenics is due to lifestyle risk factors (e.g., smoking, poor diet, being overweight, lack of exercise) or some genetic or biological component of the disease. However, this is complicated by the fact that many of these patients are treated with second-generation antipsychotics (SGAs), which might increase the risk of developing diabetes.4 Because of this, a warning regarding the risk of developing hyperglycemia and diabetes was mandated by the Food and Drug Administration (FDA) for SGA manufacturers.5

Hyperglycemia symptoms include polyuria, polydipsia, weight loss (sometimes with polyphagia), and blurred vision. Impairment of growth and susceptibility to certain infections might occur with chronic hyperglycemia. Hyperglycemia with ketoacidosis or the nonketotic hyperosmolar syndrome are acute, life-threatening consequences of uncontrolled diabetes. It is important for hospitalists and other healthcare professionals to be aware of drugs that can cause hyperglycemia or impair glucose tolerance. In some cases, the drug can be continued; in other cases, an alternate agent should be provided if necessary for patient management.

Certain drugs and drug classes known to cause hyperglycemia include: thiazide diuretics, glucocorticoids, oral contraceptives and sex hormones (e.g., testosterone), protease inhibitors, SGAs, thyroid hormone, phenytoin, niacin/nicotinic acid, diazoxide, and alfa-interferon.1-3,6

Limited evidence exists for some other agents/classes, including: asparaginase, beta-agonists, beta-blockers, calcium channel blockers, clonidine, cyclosporine, levodopa, lithium, minoxidil, phenothiazines, and others.7 The Seventh Report of the Joint National Committee (JNC 7) recommends thiazide diuretics as a first-line treatment for most patients with Stage 1 hypertension, alone or in combination for patients with diabetes.8 These thiazide doses tend to be smaller and, therefore, tend to have minimal effects on blood glucose levels.

In 2004, a consensus guideline was developed on antipsychotic drugs, obesity, and diabetes.9 It describes baseline and followup monitoring of patients treated with SGAs. The baseline includes personal/family history, weight/body mass index, waist circumference, blood pressure, FPG, and a fasting lipid profile. Monitoring of these parameters is then designated at specified times throughout treatment (e.g., weeks four, eight, 12, etc.). Haupt et al recently compared monitoring of lipids and glucose in a population of insured patients receiving SGAs in a retrospective cohort of patients pre- and post-guideline.10 Baseline lipid and glucose testing rates increased minimally post-guideline versus pre-guideline.

The results of this study demonstrate that even though monitoring guidelines to prevent potentially adverse outcomes in a patient population at high risk for developing adverse outcomes are available, clinicians do not always follow them. In order to improve patient outcomes, identified at-risk populations (e.g., patients receiving SGAs) need to be more closely evaluated and monitored throughout therapy to prevent IGT and/or diabetes. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.

References

1. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2009;32:S62-S67.
2. Luna B, Feinglos MN. Drug-induced hyperglycemia. JAMA. 2001;286:1945-1948.
3. Newcomer JW. Metabolic considerations in the use of antipsychotic medications: a review of recent evidence. J Clin Psychiatry. 2007;68(Suppl 1):20-27.
4. Tahir R. Metabolic effects of atypical antipsychotics. US Pharm. 2007;32:HS3-HS14.
5. Warning about hyperglycemia and atypical antipsychotic drugs. U.S. Food & Drug Administration Web site. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=229. Accessed March 31, 2009.
6. Kaufman MB, Simionatto C. A review of protease inhibitor-induced hyperglycemia. Pharmacotherapy. 1999;19:114-117.
7. Pandit MK, Burke J, Gustafson AB, Minocha A, Peiris AN. Drug-induced disorders of glucose tolerance. Ann Intern Med. 1993;118:529-539.
8. Chobanian AV, Bakris GL, Clack HR, et al. The seventh report of the joint national committee on prevention, detection, evaluations, and treatment of high blood pressure. JAMA. 2003;289:2560-2572.
9. American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27:596-601.
10. Haupt DW, Rosenblatt LC, Kim E, Baker RA, Whitehead R, Newcomer JW. Prevalence and predictors of lipid and glucose monitoring in commercially insured patients treated with second-generation antipsychotic agents. Am J Psychiatry. 2009;166:345-353.
11. FDA approves generic treatment for emesis. Drug Store News Web site. Available at: www.drugstorenews.com/story.aspx?id=96143. Accessed March 6, 2009.
12. Aurobindo Pharma gets tentative approval from US FDA for tenofovir disoproxil fumarate tabs. RTT News Web site. Available at: www.rttnews.com/ArticleView.aspx?id=860423. Accessed March 4, 2009.
13. Teva announces approval and launch of generic Topamax tablets.Teva Web site. Available at: www.tevapharm.com/pr/2009/pr_835.asp. Accessed March 30, 2009.
14. FDA approves Symbicort for chronic obstructive pulmonary disease (COPD). AstraZeneca Web site. Available at: www.astrazeneca-us.com/about-astrazenecaus/newsroom/all/4939997?itemId=4939997. Accessed June 5, 2009.
15. Copaxone approved by the FDA for patients with a first clinical event suggestive of multiple sclerosis. Teva Web site. Available at: www.tevapharm.com/pr/2009/ pr_826.asp? Accessed June 5, 2009.
16. Todoruk M. FDA approves new use for Wyeth’s Tygacil antibiotic. Available at: www.firstwordplus.com/Fws.do?articleid=CF71DE6056CE4120A295243AE2D6EC00. Accessed March 25, 2009.
17. FDA Web site. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf. Accessed June 5, 2009.
18. Transdermal drug patches with metallic backings. FDA Web site. Available at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm111493.htm. Accessed June 5, 2009.
19. FDA warns about risk of wearing medicated patches during MRIs. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149537.htm. Accessed March 6, 2009.
20. FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149533.htm. Accessed March 4, 2009.
21. Zonisamide (marketed as Zonegran, and generics). FDA Web site. Available at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm095251.htm. Accessed March 4, 2009.

In This Edition

Literature at a Glance: A guide to this month’s studies

• PPI use with clopidrogrel in ACS.
• Chlorhexidine sponge use reduces line infections.
• Extended thienopyridine use does not benefit DES patients.
• CABG is revascularization choice for severe CAD.
• Pre-treated CVC use reduces bloodstream infections.
• Hospitalist use grows in U.S.
• Sepsis order set improves outcomes.
• Admission day predicts acute PE mortality.

PPI Use with Clopidogrel in Acute Coronary Syndrome Is Associated with Readmissions and Mortality

Clinical question: Does concomitant use of clopidogrel and a proton pump inhibitor (PPI) following hospitalization for acute coronary syndrome (ACS) lead to adverse outcomes?

Background: Prophylactic PPIs often are prescribed with clopidogrel to reduce the risk of gastrointestinal bleeding. Mechanistic studies have shown that omeprazole decreases the platelet-inhibitory effect of clopidogrel, raising concerns that PPIs might interfere with clopidogrel’s beneficial effects. The clinical significance of this finding is unknown.

Study design: Retrospective cohort study.

Setting: 127 VA hospitals.

Synopsis: Investigators used data from the Cardiac Care Follow-up Clinical Study and VA pharmacy records to examine 8,205 male veterans who were hospitalized for ACS and treated with clopidogrel. Patients who filled prescriptions for both clopidogrel and a PPI were at significantly higher risk for death or readmission with ACS compared with those who filled prescriptions for clopidogrel only (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients who filled prescriptions for PPIs alone had similar risk for adverse events as those who took neither medication.

Subanalyses found similarly increased risk among patients prescribed omeprazole and rabeprazole, but those taking lanzoprazole and pantoprazole were not examined due to the small sample size. Although causality cannot be inferred from this observational study, and the risk associated with combined clopidigrel and PPI use appeared small, alternatives for gastric acid reduction exist. Thus, it may be prudent to restrict PPI use to patients who have a clear indication for their use until more definitive clinical trials can be conducted.

 

Bottom line: Among patients who are treated with clopidogrel for ACS, PPIs should be reserved for patients with a clear indication for gastric acid reduction and who cannot use alternative therapies.

Citation: Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937-944.

Chlorhexidine-Impregnated Sponge Use Reduces Line Infections

Clinical question: Does dressing vascular catheters with chlorhexidine gluconate-impregnated sponges (CHGIS) reduce rates of catheter-related infections, and are dressing changes every seven days inferior to every three days?

Background: Process improvement strategies—including educating providers, strictly adhering to sterile technique, and promptly removing unnecessary catheters—greatly decrease catheter-related infections. It is unclear if CHGIS dressings offer additional benefit. Also uncertain is whether weekly dressing changes are as safe as changing dressings every three days.

Study design: A 2x2 factorial, assessor-blinded, randomized controlled trial.

Setting: ICUs in three university hospitals and two general hospitals in France.

Synopsis: 1,636 French adults expected to require arterial and central venous catheters for >48 hours were randomly assigned to one of four groups. Each group received either CHGIS dressings or standard dressings, and each group had dressing changes every three or seven days. Dressings were changed sooner if soiled or nonadherent. CHGIS dressings were associated with fewer catheter-related infections than standard dressings (0.6 vs. 1.4 infections per 1,000 catheter days; P=0.03). No significant difference in rates of catheter colonization existed between the three-day and seven-day dressing change strategies (10.4 vs. 11 events per 1,000 catheter days, P>0.05).

Although microbiology assessors were blinded to patients’ status, the ICU staff was not, potentially creating experimenter bias. Approximately 30% of the venous catheters and 40% of the arterial catheters were in a femoral site. Secondary analyses found higher rates of severe dermatitis among patients with CHGIS dressings but no difference in minimal bactericidal concentration (MBC) or colonizing organisms. Preliminary calculations suggested CHGIS dressings could be cost-effective.

Bottom line: Among critically ill adults, CHGIS catheter dressings may marginally reduce catheter-related infection rates, but further evaluation is needed before this technology can be adopted widely.

Citation: Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically-ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241.

 

Thienopyridine Use Six Months after Sirolimus-Eluting Stent Implant-ation Offers No Benefit

Clinical question: What are the relative contributions of aspirin and thienopyridine on preventing stent thrombosis in patients with sirolimus-eluting stents?

Background: There are no randomized clinical trials addressing the optimal duration, or the risks associated with discontinuation, of dual-antiplatelet therapy after drug-eluting stent (DES) implantation. Nevertheless, many patients continue to be maintained on dual-antiplatelet therapy beyond one year of their index DES implantation.

Study design: Prospective multicenter observational study.

Setting: Hospitals in Japan.

Synopsis: This study observed 10,778 Japanese patients undergoing sirolimus-eluting stent implantation. Patients discontinuing both thienopyridine and aspirin had a significantly higher rate of stent thrombosis than those who continued both medications for up to 18 months. However, discontinuation of thienopyridine alone was not associated with an excess risk of stent thrombosis. Additionally, a landmark analysis of patients who were free of events at six months showed rates of death for myocardial infarction (MI) at 24 months were 4.1% for patients taking thienopyridine and 4.1% for patients not taking thienopyridine (P=0.99). Ticlodipine was the thienopyridine used by more than 95% of patients.

Hospitalists should be aware that the role thienopyridine therapy plays in reducing stent thrombosis beyond one month after implantation has not been well addressed.

Bottom line: Discontinuation of thienopyridine therapy after six months while maintaining aspirin therapy is not associated with increased risk of stent thrombosis in patients with sirolimus-eluting stents.

Citation: Kimura T, Morimoto T, Nakagawa Y, et al. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation. 2009;119(7):987-995.

Compared with PCI, CABG Results in Lower Rates of Major Adverse Events in Severe CAD Patients

Clinical question: What is the optimal revascularization strategy for previously untreated severe coronary artery disease (CAD)?

Background: Coronary artery bypass grafting (CABG) is the treatment of choice in three-vessel and left-main CAD. However, percutaneous coronary intervention (PCI) with drug-eluting stents often is utilized despite the lack of adequately powered randomized trials.

Study design: Prospective multicenter randomized clinical trial.

Setting: 85 hospitals in Europe and the U.S.

Synopsis: 1,800 patients with an average age of 65 and previously untreated three-vessel or left-main CAD amenable to therapy with both PCI and CABG were randomized to CABG or PCI. The primary combined endpoint was a major adverse cardiac or cerebrovascular event, defined as death, stroke, MI, or repeat revascularization. PCI was associated with a significantly higher rate of major adverse cardiac or cerebrovascular events, due mostly to a higher rate of repeat revascularization (13.5% vs. 5.9%, P<0.001). At 12 months, the two groups had similar rates of death from any cause or MI, and similar rates of the combined endpoint of death from any cause, stroke, or MI; however, the rate of stroke was 1.6% higher in the CABG group.

Hospitalists should continue to favor CABG over PCI but give consideration to the risks involved with such an intervention.

Bottom line: CABG remains the revascularization choice in patients with severe CAD.

Citation: Serruys PW, Morice MC, Kappetein AP, et al. Percuta-neous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360(10):961-972.

Pre-Medicated Central Venous Catheters Reduce Risk of Catheter-Related Bloodstream Infections

Clinical question: Does pre-treating central venous catheters with anti-infective agents prevent catheter-related bloodstream infections?

Background: Use of central venous catheters (CVC) is associated with catheter-related bloodstream infection (CRBSI), with CRBSI-related mortality rates as high as 25%. Previous reviews have indicated that CVCs coated or impregnated with anti-infectives may reduce CRBSI incidence. This review integrates new trial data with information from prior reviews.

 

Study design: Meta-analysis of 27 randomized controlled trials.

Setting: Meta-analysis.

Synopsis: The authors report CVCs pre-treated with anti-infectives (AI-CVCs) are clinically effective in reducing the risk of CRBSI. The odds of having a CRBSI with a treated CVC versus an untreated CVC are 0.49 to 1 (95% CI, 0.37–0.64, 27 studies, fixed effects). The study also finds the use of AI-CVCs might provide a large cost savings in Great Britain. Because the findings are based on a meta-analysis, they are limited by the quality, context, and consistency of the original studies. The authors note that many of the studies had unsatisfactory descriptions of methodology. The current study is unable to separate the risk reduction attributable to AI-CVC versus that attributable to other infection control practices. Also, original data is insufficient to assess the benefits of AI-CVCs placed for longer than 12 days.

To summarize, AI-CVCs may present a means to reduce CRBSI, but more investigation of its role within infection control protocols is needed, as is investigation of longer duration of treatment.

Bottom line: Central venous catheters pre-treated with anti-infectives significantly reduce catheter-related bloodstream infections.

Citation: Hockenhull JC, Dwan KM, Smith GW, et al. The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: a systematic review. Crit Care Med. 2009;37(2):702-712.

Fivefold Increase in Hospitalists in the U.S. from 1995 to 2006

Clinical question: What is the growth rate of hospitalists and hospitalist-provided care?

Background: Survey data has shown a sharp increase in the number of hospitalists, but until now there have not been any national or population-based data on the growth of hospitalist care.

Study design: Descriptive analysis.

Setting: Medicare-enrolled patients.

Synopsis: The study is based on national Medicare data from 2.1 million admissions involving 990,785 patients in 5,800 hospitals and 120,226 general internists. It represents 5% of inpatient Medicare claims generated by general internists. The authors define “hospitalist” as a general internist who generates >90% of his or her claims from the care of hospitalized patients.

U.S. hospitals have seen substantial growth in hospitalists over the period examined. The nation saw a 500% increase in the number of general-internist hospitalists, and a 28% increase (to 37.1% in 2006 from 9.1% in 1995) in the number of Medicare patients who received care from a hospitalist. The odds that a hospitalized Medicare patient received care from a hospitalist increased 29.2% per year from 1997 to 2006. The percentage of hospitals with at least three hospitalists rose to 47.1% in 2006 from 11.6% in 1995.

This analysis might actually have underestimated HM’s growth. Analysis of Medicare claims does not identify pediatric hospitalists and hospitalists who work exclusively within HMOs. This analysis also did not include family practitioners or internal-medicine subspecialists who are hospitalists.

Bottom line: Medicare claims data confirm survey data findings: Hospitalists and hospitalist care has grown sharply over the last decade.

Citation: Kuo YF, Sharma G, Freeman JL, Goodwin JS. Growth in the care of older patients by hospitalists in the United States. N Engl J Med. 2009;360:1102-1012.

Standardized Order Set for Bacteremic Sepsis Improves LOS and Mortality

Clinical question: Does a standardized order set for bacteremic sepsis impact patient management and outcomes?

Background: Prompt cardiovascular resuscitation and appropriate antibiotics decrease morbidity and mortality in bacteremic sepsis. This study examined whether hospitalwide, standardized sepsis order set improved management and outcomes.

Study design: Retrospective, before-and-after study design.

Setting: 1,200-bed academic medical center.

Synopsis: Two hundred patients with bacteremic severe sepsis were randomly selected from 18 months before the order set was introduced, and 200 were selected from 18 months after the order set was introduced. Primary outcomes measured were quantity of fluid administered and appropriate initial antibiotics. Secondary outcomes measured were hospital mortality and length of stay. Patients in the “after” group received more intravenous fluid (1627±1862 ml vs. 2054±2237 ml, P=.04), more appropriate antibiotics (53.0% vs. 65.5%, P=.01), had shorter hospital stays (28.7±30.1 days vs. 22.4±20.9 days, P=.02), and decreased in-house mortality (55.0% vs. 39.5%, P =<0.01).

 

The retrospective design of the study limited its ability to determine causal relationship. Extensive education may have contributed to the change (Hawthorne effect). Management in the ICU and ED, not the hospital wards, was the primary reason for mortality difference.

Bottom line: A standardized order set for bacteremic sepsis was associated with increased compliance with evidence-based treatment and improved outcomes. Hospitalists should promptly treat bacteremic sepsis with appropriate fluid resuscitation and antibiotics.

Citation: Thiel SW, Asghar MF, Micek ST, Reichley RM, Doherty JA, Kollef MH. Hospital-wide impact of a standardized order set for the management of bacteremic severe sepsis. Crit Care Med. 2009;37(3):819-824.

Admission Day of the Week Predicts Mortality in Patients with Acute Pulmonary Embolus

Clinical question: Do weekend pulmonary embolus (PE) admissions have worse outcomes than weekday admissions?

Background: Studies of patients with acute cardiovascular diagnoses (e.g., stroke, cardiac arrest) have shown higher short-term mortality and longer length of stay (LOS) for weekend versus weekday admissions. PE diagnosis is complex, requiring timely testing and experienced staff who are sometimes unavailable on weekends. Optimal anticoagulation therapy also depends on provider skill.

Study design: Retrospective observational study.

Setting: 186 private Pennsylvania hospitals, January 2000 through November 2002.

Synopsis: Using the Pennsylvania Health Care Cost Containment Council database, the authors reviewed 15,531 records of patients with a primary or secondary PE diagnosis code. The primary outcome was all-cause mortality over 30 days; LOS was the secondary outcome.

Weekend admissions in the highest severity of illness risk class had higher 30-day mortality than weekday admissions. Weekend admissions were significantly more likely than weekday admissions to be clinically unstable and to have abnormal lab parameters. Adjusted for severity of illness risk class, overall mortality was 1.4% higher for weekend versus weekday admissions. All excess mortality came from the sickest group of patients. LOS did not differ.

Less-experienced caregivers or delayed diagnostic testing may play a role in poor outcomes. Patients admitted on weekends might receive delayed care from the first onset of symptoms. This is important because timely therapy has been shown to influence outcomes in acute PE. Reasons for these observed differences should be explored further to help provide more consistent PE management, regardless of admission day.

Bottom line: The sickest patients with PE admitted on weekends experienced small but significantly greater 30-day mortality compared with those admitted on weekdays.

Citation: Aujesky D, Jimenez D, Mor M, Geng M, Fine M, Ibrahim S. Weekend versus weekday admission and mortality after acute pulmonary embolism. Circulation. 2009;119:962-968. TH

In This Edition

Literature at a Glance: A guide to this month’s studies

• PPI use with clopidrogrel in ACS.
• Chlorhexidine sponge use reduces line infections.
• Extended thienopyridine use does not benefit DES patients.
• CABG is revascularization choice for severe CAD.
• Pre-treated CVC use reduces bloodstream infections.
• Hospitalist use grows in U.S.
• Sepsis order set improves outcomes.
• Admission day predicts acute PE mortality.

PPI Use with Clopidogrel in Acute Coronary Syndrome Is Associated with Readmissions and Mortality

Clinical question: Does concomitant use of clopidogrel and a proton pump inhibitor (PPI) following hospitalization for acute coronary syndrome (ACS) lead to adverse outcomes?

Background: Prophylactic PPIs often are prescribed with clopidogrel to reduce the risk of gastrointestinal bleeding. Mechanistic studies have shown that omeprazole decreases the platelet-inhibitory effect of clopidogrel, raising concerns that PPIs might interfere with clopidogrel’s beneficial effects. The clinical significance of this finding is unknown.

Study design: Retrospective cohort study.

Setting: 127 VA hospitals.

Synopsis: Investigators used data from the Cardiac Care Follow-up Clinical Study and VA pharmacy records to examine 8,205 male veterans who were hospitalized for ACS and treated with clopidogrel. Patients who filled prescriptions for both clopidogrel and a PPI were at significantly higher risk for death or readmission with ACS compared with those who filled prescriptions for clopidogrel only (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients who filled prescriptions for PPIs alone had similar risk for adverse events as those who took neither medication.

Subanalyses found similarly increased risk among patients prescribed omeprazole and rabeprazole, but those taking lanzoprazole and pantoprazole were not examined due to the small sample size. Although causality cannot be inferred from this observational study, and the risk associated with combined clopidigrel and PPI use appeared small, alternatives for gastric acid reduction exist. Thus, it may be prudent to restrict PPI use to patients who have a clear indication for their use until more definitive clinical trials can be conducted.

 

Bottom line: Among patients who are treated with clopidogrel for ACS, PPIs should be reserved for patients with a clear indication for gastric acid reduction and who cannot use alternative therapies.

Citation: Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937-944.

Chlorhexidine-Impregnated Sponge Use Reduces Line Infections

Clinical question: Does dressing vascular catheters with chlorhexidine gluconate-impregnated sponges (CHGIS) reduce rates of catheter-related infections, and are dressing changes every seven days inferior to every three days?

Background: Process improvement strategies—including educating providers, strictly adhering to sterile technique, and promptly removing unnecessary catheters—greatly decrease catheter-related infections. It is unclear if CHGIS dressings offer additional benefit. Also uncertain is whether weekly dressing changes are as safe as changing dressings every three days.

Study design: A 2x2 factorial, assessor-blinded, randomized controlled trial.

Setting: ICUs in three university hospitals and two general hospitals in France.

Synopsis: 1,636 French adults expected to require arterial and central venous catheters for >48 hours were randomly assigned to one of four groups. Each group received either CHGIS dressings or standard dressings, and each group had dressing changes every three or seven days. Dressings were changed sooner if soiled or nonadherent. CHGIS dressings were associated with fewer catheter-related infections than standard dressings (0.6 vs. 1.4 infections per 1,000 catheter days; P=0.03). No significant difference in rates of catheter colonization existed between the three-day and seven-day dressing change strategies (10.4 vs. 11 events per 1,000 catheter days, P>0.05).

Although microbiology assessors were blinded to patients’ status, the ICU staff was not, potentially creating experimenter bias. Approximately 30% of the venous catheters and 40% of the arterial catheters were in a femoral site. Secondary analyses found higher rates of severe dermatitis among patients with CHGIS dressings but no difference in minimal bactericidal concentration (MBC) or colonizing organisms. Preliminary calculations suggested CHGIS dressings could be cost-effective.

Bottom line: Among critically ill adults, CHGIS catheter dressings may marginally reduce catheter-related infection rates, but further evaluation is needed before this technology can be adopted widely.

Citation: Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically-ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241.

 

Thienopyridine Use Six Months after Sirolimus-Eluting Stent Implant-ation Offers No Benefit

Clinical question: What are the relative contributions of aspirin and thienopyridine on preventing stent thrombosis in patients with sirolimus-eluting stents?

Background: There are no randomized clinical trials addressing the optimal duration, or the risks associated with discontinuation, of dual-antiplatelet therapy after drug-eluting stent (DES) implantation. Nevertheless, many patients continue to be maintained on dual-antiplatelet therapy beyond one year of their index DES implantation.

Study design: Prospective multicenter observational study.

Setting: Hospitals in Japan.

Synopsis: This study observed 10,778 Japanese patients undergoing sirolimus-eluting stent implantation. Patients discontinuing both thienopyridine and aspirin had a significantly higher rate of stent thrombosis than those who continued both medications for up to 18 months. However, discontinuation of thienopyridine alone was not associated with an excess risk of stent thrombosis. Additionally, a landmark analysis of patients who were free of events at six months showed rates of death for myocardial infarction (MI) at 24 months were 4.1% for patients taking thienopyridine and 4.1% for patients not taking thienopyridine (P=0.99). Ticlodipine was the thienopyridine used by more than 95% of patients.

Hospitalists should be aware that the role thienopyridine therapy plays in reducing stent thrombosis beyond one month after implantation has not been well addressed.

Bottom line: Discontinuation of thienopyridine therapy after six months while maintaining aspirin therapy is not associated with increased risk of stent thrombosis in patients with sirolimus-eluting stents.

Citation: Kimura T, Morimoto T, Nakagawa Y, et al. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation. 2009;119(7):987-995.

Compared with PCI, CABG Results in Lower Rates of Major Adverse Events in Severe CAD Patients

Clinical question: What is the optimal revascularization strategy for previously untreated severe coronary artery disease (CAD)?

Background: Coronary artery bypass grafting (CABG) is the treatment of choice in three-vessel and left-main CAD. However, percutaneous coronary intervention (PCI) with drug-eluting stents often is utilized despite the lack of adequately powered randomized trials.

Study design: Prospective multicenter randomized clinical trial.

Setting: 85 hospitals in Europe and the U.S.

Synopsis: 1,800 patients with an average age of 65 and previously untreated three-vessel or left-main CAD amenable to therapy with both PCI and CABG were randomized to CABG or PCI. The primary combined endpoint was a major adverse cardiac or cerebrovascular event, defined as death, stroke, MI, or repeat revascularization. PCI was associated with a significantly higher rate of major adverse cardiac or cerebrovascular events, due mostly to a higher rate of repeat revascularization (13.5% vs. 5.9%, P<0.001). At 12 months, the two groups had similar rates of death from any cause or MI, and similar rates of the combined endpoint of death from any cause, stroke, or MI; however, the rate of stroke was 1.6% higher in the CABG group.

Hospitalists should continue to favor CABG over PCI but give consideration to the risks involved with such an intervention.

Bottom line: CABG remains the revascularization choice in patients with severe CAD.

Citation: Serruys PW, Morice MC, Kappetein AP, et al. Percuta-neous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360(10):961-972.

Pre-Medicated Central Venous Catheters Reduce Risk of Catheter-Related Bloodstream Infections

Clinical question: Does pre-treating central venous catheters with anti-infective agents prevent catheter-related bloodstream infections?

Background: Use of central venous catheters (CVC) is associated with catheter-related bloodstream infection (CRBSI), with CRBSI-related mortality rates as high as 25%. Previous reviews have indicated that CVCs coated or impregnated with anti-infectives may reduce CRBSI incidence. This review integrates new trial data with information from prior reviews.

 

Study design: Meta-analysis of 27 randomized controlled trials.

Setting: Meta-analysis.

Synopsis: The authors report CVCs pre-treated with anti-infectives (AI-CVCs) are clinically effective in reducing the risk of CRBSI. The odds of having a CRBSI with a treated CVC versus an untreated CVC are 0.49 to 1 (95% CI, 0.37–0.64, 27 studies, fixed effects). The study also finds the use of AI-CVCs might provide a large cost savings in Great Britain. Because the findings are based on a meta-analysis, they are limited by the quality, context, and consistency of the original studies. The authors note that many of the studies had unsatisfactory descriptions of methodology. The current study is unable to separate the risk reduction attributable to AI-CVC versus that attributable to other infection control practices. Also, original data is insufficient to assess the benefits of AI-CVCs placed for longer than 12 days.

To summarize, AI-CVCs may present a means to reduce CRBSI, but more investigation of its role within infection control protocols is needed, as is investigation of longer duration of treatment.

Bottom line: Central venous catheters pre-treated with anti-infectives significantly reduce catheter-related bloodstream infections.

Citation: Hockenhull JC, Dwan KM, Smith GW, et al. The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: a systematic review. Crit Care Med. 2009;37(2):702-712.

Fivefold Increase in Hospitalists in the U.S. from 1995 to 2006

Clinical question: What is the growth rate of hospitalists and hospitalist-provided care?

Background: Survey data has shown a sharp increase in the number of hospitalists, but until now there have not been any national or population-based data on the growth of hospitalist care.

Study design: Descriptive analysis.

Setting: Medicare-enrolled patients.

Synopsis: The study is based on national Medicare data from 2.1 million admissions involving 990,785 patients in 5,800 hospitals and 120,226 general internists. It represents 5% of inpatient Medicare claims generated by general internists. The authors define “hospitalist” as a general internist who generates >90% of his or her claims from the care of hospitalized patients.

U.S. hospitals have seen substantial growth in hospitalists over the period examined. The nation saw a 500% increase in the number of general-internist hospitalists, and a 28% increase (to 37.1% in 2006 from 9.1% in 1995) in the number of Medicare patients who received care from a hospitalist. The odds that a hospitalized Medicare patient received care from a hospitalist increased 29.2% per year from 1997 to 2006. The percentage of hospitals with at least three hospitalists rose to 47.1% in 2006 from 11.6% in 1995.

This analysis might actually have underestimated HM’s growth. Analysis of Medicare claims does not identify pediatric hospitalists and hospitalists who work exclusively within HMOs. This analysis also did not include family practitioners or internal-medicine subspecialists who are hospitalists.

Bottom line: Medicare claims data confirm survey data findings: Hospitalists and hospitalist care has grown sharply over the last decade.

Citation: Kuo YF, Sharma G, Freeman JL, Goodwin JS. Growth in the care of older patients by hospitalists in the United States. N Engl J Med. 2009;360:1102-1012.

Standardized Order Set for Bacteremic Sepsis Improves LOS and Mortality

Clinical question: Does a standardized order set for bacteremic sepsis impact patient management and outcomes?

Background: Prompt cardiovascular resuscitation and appropriate antibiotics decrease morbidity and mortality in bacteremic sepsis. This study examined whether hospitalwide, standardized sepsis order set improved management and outcomes.

Study design: Retrospective, before-and-after study design.

Setting: 1,200-bed academic medical center.

Synopsis: Two hundred patients with bacteremic severe sepsis were randomly selected from 18 months before the order set was introduced, and 200 were selected from 18 months after the order set was introduced. Primary outcomes measured were quantity of fluid administered and appropriate initial antibiotics. Secondary outcomes measured were hospital mortality and length of stay. Patients in the “after” group received more intravenous fluid (1627±1862 ml vs. 2054±2237 ml, P=.04), more appropriate antibiotics (53.0% vs. 65.5%, P=.01), had shorter hospital stays (28.7±30.1 days vs. 22.4±20.9 days, P=.02), and decreased in-house mortality (55.0% vs. 39.5%, P =<0.01).

 

The retrospective design of the study limited its ability to determine causal relationship. Extensive education may have contributed to the change (Hawthorne effect). Management in the ICU and ED, not the hospital wards, was the primary reason for mortality difference.

Bottom line: A standardized order set for bacteremic sepsis was associated with increased compliance with evidence-based treatment and improved outcomes. Hospitalists should promptly treat bacteremic sepsis with appropriate fluid resuscitation and antibiotics.

Citation: Thiel SW, Asghar MF, Micek ST, Reichley RM, Doherty JA, Kollef MH. Hospital-wide impact of a standardized order set for the management of bacteremic severe sepsis. Crit Care Med. 2009;37(3):819-824.

Admission Day of the Week Predicts Mortality in Patients with Acute Pulmonary Embolus

Clinical question: Do weekend pulmonary embolus (PE) admissions have worse outcomes than weekday admissions?

Background: Studies of patients with acute cardiovascular diagnoses (e.g., stroke, cardiac arrest) have shown higher short-term mortality and longer length of stay (LOS) for weekend versus weekday admissions. PE diagnosis is complex, requiring timely testing and experienced staff who are sometimes unavailable on weekends. Optimal anticoagulation therapy also depends on provider skill.

Study design: Retrospective observational study.

Setting: 186 private Pennsylvania hospitals, January 2000 through November 2002.

Synopsis: Using the Pennsylvania Health Care Cost Containment Council database, the authors reviewed 15,531 records of patients with a primary or secondary PE diagnosis code. The primary outcome was all-cause mortality over 30 days; LOS was the secondary outcome.

Weekend admissions in the highest severity of illness risk class had higher 30-day mortality than weekday admissions. Weekend admissions were significantly more likely than weekday admissions to be clinically unstable and to have abnormal lab parameters. Adjusted for severity of illness risk class, overall mortality was 1.4% higher for weekend versus weekday admissions. All excess mortality came from the sickest group of patients. LOS did not differ.

Less-experienced caregivers or delayed diagnostic testing may play a role in poor outcomes. Patients admitted on weekends might receive delayed care from the first onset of symptoms. This is important because timely therapy has been shown to influence outcomes in acute PE. Reasons for these observed differences should be explored further to help provide more consistent PE management, regardless of admission day.

Bottom line: The sickest patients with PE admitted on weekends experienced small but significantly greater 30-day mortality compared with those admitted on weekdays.

Citation: Aujesky D, Jimenez D, Mor M, Geng M, Fine M, Ibrahim S. Weekend versus weekday admission and mortality after acute pulmonary embolism. Circulation. 2009;119:962-968. TH

In This Edition

Literature at a Glance: A guide to this month’s studies

• PPI use with clopidrogrel in ACS.
• Chlorhexidine sponge use reduces line infections.
• Extended thienopyridine use does not benefit DES patients.
• CABG is revascularization choice for severe CAD.
• Pre-treated CVC use reduces bloodstream infections.
• Hospitalist use grows in U.S.
• Sepsis order set improves outcomes.
• Admission day predicts acute PE mortality.

PPI Use with Clopidogrel in Acute Coronary Syndrome Is Associated with Readmissions and Mortality

Clinical question: Does concomitant use of clopidogrel and a proton pump inhibitor (PPI) following hospitalization for acute coronary syndrome (ACS) lead to adverse outcomes?

Background: Prophylactic PPIs often are prescribed with clopidogrel to reduce the risk of gastrointestinal bleeding. Mechanistic studies have shown that omeprazole decreases the platelet-inhibitory effect of clopidogrel, raising concerns that PPIs might interfere with clopidogrel’s beneficial effects. The clinical significance of this finding is unknown.

Study design: Retrospective cohort study.

Setting: 127 VA hospitals.

Synopsis: Investigators used data from the Cardiac Care Follow-up Clinical Study and VA pharmacy records to examine 8,205 male veterans who were hospitalized for ACS and treated with clopidogrel. Patients who filled prescriptions for both clopidogrel and a PPI were at significantly higher risk for death or readmission with ACS compared with those who filled prescriptions for clopidogrel only (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients who filled prescriptions for PPIs alone had similar risk for adverse events as those who took neither medication.

Subanalyses found similarly increased risk among patients prescribed omeprazole and rabeprazole, but those taking lanzoprazole and pantoprazole were not examined due to the small sample size. Although causality cannot be inferred from this observational study, and the risk associated with combined clopidigrel and PPI use appeared small, alternatives for gastric acid reduction exist. Thus, it may be prudent to restrict PPI use to patients who have a clear indication for their use until more definitive clinical trials can be conducted.

 

Bottom line: Among patients who are treated with clopidogrel for ACS, PPIs should be reserved for patients with a clear indication for gastric acid reduction and who cannot use alternative therapies.

Citation: Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937-944.

Chlorhexidine-Impregnated Sponge Use Reduces Line Infections

Clinical question: Does dressing vascular catheters with chlorhexidine gluconate-impregnated sponges (CHGIS) reduce rates of catheter-related infections, and are dressing changes every seven days inferior to every three days?

Background: Process improvement strategies—including educating providers, strictly adhering to sterile technique, and promptly removing unnecessary catheters—greatly decrease catheter-related infections. It is unclear if CHGIS dressings offer additional benefit. Also uncertain is whether weekly dressing changes are as safe as changing dressings every three days.

Study design: A 2x2 factorial, assessor-blinded, randomized controlled trial.

Setting: ICUs in three university hospitals and two general hospitals in France.

Synopsis: 1,636 French adults expected to require arterial and central venous catheters for >48 hours were randomly assigned to one of four groups. Each group received either CHGIS dressings or standard dressings, and each group had dressing changes every three or seven days. Dressings were changed sooner if soiled or nonadherent. CHGIS dressings were associated with fewer catheter-related infections than standard dressings (0.6 vs. 1.4 infections per 1,000 catheter days; P=0.03). No significant difference in rates of catheter colonization existed between the three-day and seven-day dressing change strategies (10.4 vs. 11 events per 1,000 catheter days, P>0.05).

Although microbiology assessors were blinded to patients’ status, the ICU staff was not, potentially creating experimenter bias. Approximately 30% of the venous catheters and 40% of the arterial catheters were in a femoral site. Secondary analyses found higher rates of severe dermatitis among patients with CHGIS dressings but no difference in minimal bactericidal concentration (MBC) or colonizing organisms. Preliminary calculations suggested CHGIS dressings could be cost-effective.

Bottom line: Among critically ill adults, CHGIS catheter dressings may marginally reduce catheter-related infection rates, but further evaluation is needed before this technology can be adopted widely.

Citation: Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically-ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241.

 

Thienopyridine Use Six Months after Sirolimus-Eluting Stent Implant-ation Offers No Benefit

Clinical question: What are the relative contributions of aspirin and thienopyridine on preventing stent thrombosis in patients with sirolimus-eluting stents?

Background: There are no randomized clinical trials addressing the optimal duration, or the risks associated with discontinuation, of dual-antiplatelet therapy after drug-eluting stent (DES) implantation. Nevertheless, many patients continue to be maintained on dual-antiplatelet therapy beyond one year of their index DES implantation.

Study design: Prospective multicenter observational study.

Setting: Hospitals in Japan.

Synopsis: This study observed 10,778 Japanese patients undergoing sirolimus-eluting stent implantation. Patients discontinuing both thienopyridine and aspirin had a significantly higher rate of stent thrombosis than those who continued both medications for up to 18 months. However, discontinuation of thienopyridine alone was not associated with an excess risk of stent thrombosis. Additionally, a landmark analysis of patients who were free of events at six months showed rates of death for myocardial infarction (MI) at 24 months were 4.1% for patients taking thienopyridine and 4.1% for patients not taking thienopyridine (P=0.99). Ticlodipine was the thienopyridine used by more than 95% of patients.

Hospitalists should be aware that the role thienopyridine therapy plays in reducing stent thrombosis beyond one month after implantation has not been well addressed.

Bottom line: Discontinuation of thienopyridine therapy after six months while maintaining aspirin therapy is not associated with increased risk of stent thrombosis in patients with sirolimus-eluting stents.

Citation: Kimura T, Morimoto T, Nakagawa Y, et al. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation. 2009;119(7):987-995.

Compared with PCI, CABG Results in Lower Rates of Major Adverse Events in Severe CAD Patients

Clinical question: What is the optimal revascularization strategy for previously untreated severe coronary artery disease (CAD)?

Background: Coronary artery bypass grafting (CABG) is the treatment of choice in three-vessel and left-main CAD. However, percutaneous coronary intervention (PCI) with drug-eluting stents often is utilized despite the lack of adequately powered randomized trials.

Study design: Prospective multicenter randomized clinical trial.

Setting: 85 hospitals in Europe and the U.S.

Synopsis: 1,800 patients with an average age of 65 and previously untreated three-vessel or left-main CAD amenable to therapy with both PCI and CABG were randomized to CABG or PCI. The primary combined endpoint was a major adverse cardiac or cerebrovascular event, defined as death, stroke, MI, or repeat revascularization. PCI was associated with a significantly higher rate of major adverse cardiac or cerebrovascular events, due mostly to a higher rate of repeat revascularization (13.5% vs. 5.9%, P<0.001). At 12 months, the two groups had similar rates of death from any cause or MI, and similar rates of the combined endpoint of death from any cause, stroke, or MI; however, the rate of stroke was 1.6% higher in the CABG group.

Hospitalists should continue to favor CABG over PCI but give consideration to the risks involved with such an intervention.

Bottom line: CABG remains the revascularization choice in patients with severe CAD.

Citation: Serruys PW, Morice MC, Kappetein AP, et al. Percuta-neous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360(10):961-972.

Pre-Medicated Central Venous Catheters Reduce Risk of Catheter-Related Bloodstream Infections

Clinical question: Does pre-treating central venous catheters with anti-infective agents prevent catheter-related bloodstream infections?

Background: Use of central venous catheters (CVC) is associated with catheter-related bloodstream infection (CRBSI), with CRBSI-related mortality rates as high as 25%. Previous reviews have indicated that CVCs coated or impregnated with anti-infectives may reduce CRBSI incidence. This review integrates new trial data with information from prior reviews.

 

Study design: Meta-analysis of 27 randomized controlled trials.

Setting: Meta-analysis.

Synopsis: The authors report CVCs pre-treated with anti-infectives (AI-CVCs) are clinically effective in reducing the risk of CRBSI. The odds of having a CRBSI with a treated CVC versus an untreated CVC are 0.49 to 1 (95% CI, 0.37–0.64, 27 studies, fixed effects). The study also finds the use of AI-CVCs might provide a large cost savings in Great Britain. Because the findings are based on a meta-analysis, they are limited by the quality, context, and consistency of the original studies. The authors note that many of the studies had unsatisfactory descriptions of methodology. The current study is unable to separate the risk reduction attributable to AI-CVC versus that attributable to other infection control practices. Also, original data is insufficient to assess the benefits of AI-CVCs placed for longer than 12 days.

To summarize, AI-CVCs may present a means to reduce CRBSI, but more investigation of its role within infection control protocols is needed, as is investigation of longer duration of treatment.

Bottom line: Central venous catheters pre-treated with anti-infectives significantly reduce catheter-related bloodstream infections.

Citation: Hockenhull JC, Dwan KM, Smith GW, et al. The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: a systematic review. Crit Care Med. 2009;37(2):702-712.

Fivefold Increase in Hospitalists in the U.S. from 1995 to 2006

Clinical question: What is the growth rate of hospitalists and hospitalist-provided care?

Background: Survey data has shown a sharp increase in the number of hospitalists, but until now there have not been any national or population-based data on the growth of hospitalist care.

Study design: Descriptive analysis.

Setting: Medicare-enrolled patients.

Synopsis: The study is based on national Medicare data from 2.1 million admissions involving 990,785 patients in 5,800 hospitals and 120,226 general internists. It represents 5% of inpatient Medicare claims generated by general internists. The authors define “hospitalist” as a general internist who generates >90% of his or her claims from the care of hospitalized patients.

U.S. hospitals have seen substantial growth in hospitalists over the period examined. The nation saw a 500% increase in the number of general-internist hospitalists, and a 28% increase (to 37.1% in 2006 from 9.1% in 1995) in the number of Medicare patients who received care from a hospitalist. The odds that a hospitalized Medicare patient received care from a hospitalist increased 29.2% per year from 1997 to 2006. The percentage of hospitals with at least three hospitalists rose to 47.1% in 2006 from 11.6% in 1995.

This analysis might actually have underestimated HM’s growth. Analysis of Medicare claims does not identify pediatric hospitalists and hospitalists who work exclusively within HMOs. This analysis also did not include family practitioners or internal-medicine subspecialists who are hospitalists.

Bottom line: Medicare claims data confirm survey data findings: Hospitalists and hospitalist care has grown sharply over the last decade.

Citation: Kuo YF, Sharma G, Freeman JL, Goodwin JS. Growth in the care of older patients by hospitalists in the United States. N Engl J Med. 2009;360:1102-1012.

Standardized Order Set for Bacteremic Sepsis Improves LOS and Mortality

Clinical question: Does a standardized order set for bacteremic sepsis impact patient management and outcomes?

Background: Prompt cardiovascular resuscitation and appropriate antibiotics decrease morbidity and mortality in bacteremic sepsis. This study examined whether hospitalwide, standardized sepsis order set improved management and outcomes.

Study design: Retrospective, before-and-after study design.

Setting: 1,200-bed academic medical center.

Synopsis: Two hundred patients with bacteremic severe sepsis were randomly selected from 18 months before the order set was introduced, and 200 were selected from 18 months after the order set was introduced. Primary outcomes measured were quantity of fluid administered and appropriate initial antibiotics. Secondary outcomes measured were hospital mortality and length of stay. Patients in the “after” group received more intravenous fluid (1627±1862 ml vs. 2054±2237 ml, P=.04), more appropriate antibiotics (53.0% vs. 65.5%, P=.01), had shorter hospital stays (28.7±30.1 days vs. 22.4±20.9 days, P=.02), and decreased in-house mortality (55.0% vs. 39.5%, P =<0.01).

 

The retrospective design of the study limited its ability to determine causal relationship. Extensive education may have contributed to the change (Hawthorne effect). Management in the ICU and ED, not the hospital wards, was the primary reason for mortality difference.

Bottom line: A standardized order set for bacteremic sepsis was associated with increased compliance with evidence-based treatment and improved outcomes. Hospitalists should promptly treat bacteremic sepsis with appropriate fluid resuscitation and antibiotics.

Citation: Thiel SW, Asghar MF, Micek ST, Reichley RM, Doherty JA, Kollef MH. Hospital-wide impact of a standardized order set for the management of bacteremic severe sepsis. Crit Care Med. 2009;37(3):819-824.

Admission Day of the Week Predicts Mortality in Patients with Acute Pulmonary Embolus

Clinical question: Do weekend pulmonary embolus (PE) admissions have worse outcomes than weekday admissions?

Background: Studies of patients with acute cardiovascular diagnoses (e.g., stroke, cardiac arrest) have shown higher short-term mortality and longer length of stay (LOS) for weekend versus weekday admissions. PE diagnosis is complex, requiring timely testing and experienced staff who are sometimes unavailable on weekends. Optimal anticoagulation therapy also depends on provider skill.

Study design: Retrospective observational study.

Setting: 186 private Pennsylvania hospitals, January 2000 through November 2002.

Synopsis: Using the Pennsylvania Health Care Cost Containment Council database, the authors reviewed 15,531 records of patients with a primary or secondary PE diagnosis code. The primary outcome was all-cause mortality over 30 days; LOS was the secondary outcome.

Weekend admissions in the highest severity of illness risk class had higher 30-day mortality than weekday admissions. Weekend admissions were significantly more likely than weekday admissions to be clinically unstable and to have abnormal lab parameters. Adjusted for severity of illness risk class, overall mortality was 1.4% higher for weekend versus weekday admissions. All excess mortality came from the sickest group of patients. LOS did not differ.

Less-experienced caregivers or delayed diagnostic testing may play a role in poor outcomes. Patients admitted on weekends might receive delayed care from the first onset of symptoms. This is important because timely therapy has been shown to influence outcomes in acute PE. Reasons for these observed differences should be explored further to help provide more consistent PE management, regardless of admission day.

Bottom line: The sickest patients with PE admitted on weekends experienced small but significantly greater 30-day mortality compared with those admitted on weekdays.

Citation: Aujesky D, Jimenez D, Mor M, Geng M, Fine M, Ibrahim S. Weekend versus weekday admission and mortality after acute pulmonary embolism. Circulation. 2009;119:962-968. TH

Younger generations blaze new paths through the American economy. Fifteen years ago, Generation X was fresh out of college and flush with the unimagined potential of the Internet. They helped change the way the world shared information and conducted business. The impact of such innovation and enthusiasm for new technology is still felt today.

The healthcare sector possesses pioneers of its own, many with the same kind of drive and vision as the dot-com entrepreneurs of the 1990s. Fifteen years from now, today’s young hospitalists—shaped by ever-changing demands and healthcare hurdles—will be recognized as an authority in the new ways patient care is delivered.

Bijo Chacko, MD, FHM, former chair of SHM’s Young Physicians Committee, sees energy in the newest generation of hospitalists. He also sees great potential from residents who are finishing their training and considering their job options. Until recently, SHM’s Young Physicians Committee operated as a task force. The group’s growth and increased young-physician representation throughout the society prompted SHM leadership to promote the task force to full committee status.

“The wonderful thing is that we have received lots of input from around the country and dramatically increased membership in the past few years,” says Dr. Chacko, hospital medicine medical director for Preferred Health Partners in New York City. “We have moved from simply gathering information about young physicians in hospital medicine to actively disseminating it, including the new Resident’s Corner [department in The Hospitalist]. It addresses the needs of residents and introduces them to the nuances and specifics of hospital medicine.”

The demand for information has spurred the launch of a young physicians section (www.hospitalmedicine.org/youngdoctor) on SHM’s Web site. Combined with SHM’s online career center (www.hospitalmedicine.org/careercenter), the new microsites provide young physicians a broad range of information about the specialty and—most importantly—HM career options.

Natural Progression

Four out of five large hospitals now use hospitalists, and as more hospitals implement HM programs, more residents will be exposed to the hospitalist model of care. For residents, the allure of an HM career is broad and deep. In many ways, HM is the logical extension of residency training. Brian Markoff, MD, FHM, a hospitalist and associate professor of medicine at Mount Sinai Hospitalist Group in New York City, was a chief resident when he founded the hospitalist program at the University of California at Davis Health System in Sacramento in 1998.

 

“Creating the hospitalist program at UC-Davis was pretty easy,” Dr. Markoff says. “All of the program’s founders were chief residents at the time. The people involved were warm to the idea, and we could teach without being in the fellowship program. Residents are already very comfortable treating patients in the hospital setting.”

Dr. Markoff says practicing hospitalists are a positive influence on residents who are still undecided on a career path. “If you’re a good role model, they’ll be interested in hospital medicine,” he says.

Diversity of Patients, Issues, Settings

Dr. Markoff and others caution that HM encompasses more than an expansion of a resident’s standard roles and responsibilities. “We’re not just super-residents,” he says. “We’re highly trained specialists in the care of hospitalized patients and the process of making care in hospital better.”

Medical conditions, patient issues, and administrative situations that often are outside a resident’s scope quickly come into focus for a new hospitalist. When Mona Patel, DO, associate director of hospitalist services at Staten Island University Hospital in New York, chose an HM career five years ago, the diversity in opportunities was a major draw. Like many hospitalists, she knew she would enjoy the type of care she provides to patients.

“I liked the acuity of the patients and disease processes; it was much more interesting and exciting for me than ongoing outpatient care of chronic diseases,” Dr. Patel says. “I liked the interaction with the hospital house staff and lots of consultants. If I had questions about a patient, I could easily consult with a specialist within the hospital.”

In addition to providing bedside care, new hospitalists often find themselves at the forefront of a monumental change in how healthcare is provided nationwide. Quality improvement (QI) initiatives, such as reducing preventable diseases in the hospital and reducing readmission rates, attracted Bryan Huang, MD, to hospital medicine at the University of California at San Diego.

“When I interviewed at UCSD, I was very interested in quality improvement,” says Dr. Huang, an assistant clinical professor at UCSD’s Division of Hospital Medicine. “UCSD is well known for glycemic control and VTE prophylaxis. We’re now working on quality improvement for treating delirium and hospital discharge.”

His experience as an academic hospitalist has opened up the QI world to him. “Before this job, I was almost not familiar at all with quality improvement,” Dr. Huang says. “As a resident, I did some quality-improvement work, but not much. Quality improvement was missing from residency training, but it’s getting better.”

Dr. Patel says HM’s biggest selling point is the variety of settings available to a new hospitalist. She’s been working for the past two years in an academic hospital program in a community hospital setting with 20 hospitalists. Before that, she worked in private practice as a hospitalist. Now, when she talks with residents, she talks about their options.

“It’s really important that you figure out what kind of setting you want,” Dr. Patel says. “Hospital medicine has a diversity of settings, from a small community hospital where you do a broad range of inpatient care to a larger academic teaching environment or a private practice group.”

Leadership Opportunities

The continuing demand for hospitalists affords young physicians who are considering an HM career additional freedom in the job market. In comparison to more traditional primary-care models, hospitalist jobs offer flexible hours and competitive salaries.

Dr. Chacko points to another benefit that is a direct result of the high demand for hospitalists: increased opportunities to launch management careers. The average age of a hospitalist is 37 and the average age of an HM group leader is 41, according to SHM’s 2007-2008 Bi-Annual Survey on the State of the Hospital Medicine Movement.

 

“That’s not that much of a difference,” Dr. Chacko says. “Early-career hospitalists find ample leadership opportunities in the specialty. There are lots of opportunities for young hospitalists.”

How to Get Started

Because most teaching hospitals have hospitalists, most residents are exposed to HM. Many hospitalists relish the opportunity to mentor and provide early-career counseling. “Sometimes, a resident will ask to grab coffee and learn more about hospital medicine,” Dr. Huang says. “I tell them what my job is like. Many ask, ‘How do I get started looking for a job?’ I tell them that connections really help. Word of mouth is very important, so I refer people to other people.”

Margaret Fang, MD, MPH, FHM, assistant professor of medicine at the University of California at San Francisco’s division of hospital medicine and a founding member of the Young Physicians Committee, recommends that residents begin with a vision and work backward. “On a broad level, if you’re a resident, you should think about where you want to be in five years,” she says. “Look around your hospital and find a few people whose job you want.”

For some young physicians, looking ahead five years could mean being part of the healthcare revolution of tomorrow. TH

Brendon Shank is a freelance writer based in Philadelphia.

SHM elects board members

SHM has elected three new members to its Board of Directors and re-elected two members. Board members are nominated and elected by the membership and serve a three-year term.The newly elected members of the board are:

Eric Howell, MD, FHM, associate professor of medicine at Johns Hopkins University School of Medicine and director of the hospitalist division and hospital care at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Howell is a member of the Leadership Academy faculty and received the 2009 Award for Excellence in Teaching.

 

Burke Kealey, MD, FHM, assistant medical director of Health Partners Medical Group in Minneapolis and adjunct assistant professor of internal medicine at the University of Minnesota. Dr. Kealey has been an active member of SHM for more than 10 years and earned the society’s 2003 Award for Clinical Excellence.

 

 

Dan Dressler, MD, MSc, FHM, director of education at Emory University School of Medicine in Atlanta. A member of SHM’s Education Committee and Leadership Academy faculty, Dr. Dressler received Emory’s Hospital Medicine Leadership Award in 2006 and Hospital Medicine Teaching Award in 2007.

 

Re-elected board members:

Jeffrey Wiese, MD, FHM, professor of medicine, associate dean for graduate medical education, and associate professor of medicine at Tulane University Health Sciences Center in New Orleans. Dr. Wiese also was voted 2010-2011 board president-elect.

 

Jack Percelay, MD, MPH, FHM, FAAP, pediatric hospitalist with ELMO Pediatrics in New York City. Dr. Percelay was first elected to the board in 2005 and represents pediatric hospitalists.

Younger generations blaze new paths through the American economy. Fifteen years ago, Generation X was fresh out of college and flush with the unimagined potential of the Internet. They helped change the way the world shared information and conducted business. The impact of such innovation and enthusiasm for new technology is still felt today.

The healthcare sector possesses pioneers of its own, many with the same kind of drive and vision as the dot-com entrepreneurs of the 1990s. Fifteen years from now, today’s young hospitalists—shaped by ever-changing demands and healthcare hurdles—will be recognized as an authority in the new ways patient care is delivered.

Bijo Chacko, MD, FHM, former chair of SHM’s Young Physicians Committee, sees energy in the newest generation of hospitalists. He also sees great potential from residents who are finishing their training and considering their job options. Until recently, SHM’s Young Physicians Committee operated as a task force. The group’s growth and increased young-physician representation throughout the society prompted SHM leadership to promote the task force to full committee status.

“The wonderful thing is that we have received lots of input from around the country and dramatically increased membership in the past few years,” says Dr. Chacko, hospital medicine medical director for Preferred Health Partners in New York City. “We have moved from simply gathering information about young physicians in hospital medicine to actively disseminating it, including the new Resident’s Corner [department in The Hospitalist]. It addresses the needs of residents and introduces them to the nuances and specifics of hospital medicine.”

The demand for information has spurred the launch of a young physicians section (www.hospitalmedicine.org/youngdoctor) on SHM’s Web site. Combined with SHM’s online career center (www.hospitalmedicine.org/careercenter), the new microsites provide young physicians a broad range of information about the specialty and—most importantly—HM career options.

Natural Progression

Four out of five large hospitals now use hospitalists, and as more hospitals implement HM programs, more residents will be exposed to the hospitalist model of care. For residents, the allure of an HM career is broad and deep. In many ways, HM is the logical extension of residency training. Brian Markoff, MD, FHM, a hospitalist and associate professor of medicine at Mount Sinai Hospitalist Group in New York City, was a chief resident when he founded the hospitalist program at the University of California at Davis Health System in Sacramento in 1998.

 

“Creating the hospitalist program at UC-Davis was pretty easy,” Dr. Markoff says. “All of the program’s founders were chief residents at the time. The people involved were warm to the idea, and we could teach without being in the fellowship program. Residents are already very comfortable treating patients in the hospital setting.”

Dr. Markoff says practicing hospitalists are a positive influence on residents who are still undecided on a career path. “If you’re a good role model, they’ll be interested in hospital medicine,” he says.

Diversity of Patients, Issues, Settings

Dr. Markoff and others caution that HM encompasses more than an expansion of a resident’s standard roles and responsibilities. “We’re not just super-residents,” he says. “We’re highly trained specialists in the care of hospitalized patients and the process of making care in hospital better.”

Medical conditions, patient issues, and administrative situations that often are outside a resident’s scope quickly come into focus for a new hospitalist. When Mona Patel, DO, associate director of hospitalist services at Staten Island University Hospital in New York, chose an HM career five years ago, the diversity in opportunities was a major draw. Like many hospitalists, she knew she would enjoy the type of care she provides to patients.

“I liked the acuity of the patients and disease processes; it was much more interesting and exciting for me than ongoing outpatient care of chronic diseases,” Dr. Patel says. “I liked the interaction with the hospital house staff and lots of consultants. If I had questions about a patient, I could easily consult with a specialist within the hospital.”

In addition to providing bedside care, new hospitalists often find themselves at the forefront of a monumental change in how healthcare is provided nationwide. Quality improvement (QI) initiatives, such as reducing preventable diseases in the hospital and reducing readmission rates, attracted Bryan Huang, MD, to hospital medicine at the University of California at San Diego.

“When I interviewed at UCSD, I was very interested in quality improvement,” says Dr. Huang, an assistant clinical professor at UCSD’s Division of Hospital Medicine. “UCSD is well known for glycemic control and VTE prophylaxis. We’re now working on quality improvement for treating delirium and hospital discharge.”

His experience as an academic hospitalist has opened up the QI world to him. “Before this job, I was almost not familiar at all with quality improvement,” Dr. Huang says. “As a resident, I did some quality-improvement work, but not much. Quality improvement was missing from residency training, but it’s getting better.”

Dr. Patel says HM’s biggest selling point is the variety of settings available to a new hospitalist. She’s been working for the past two years in an academic hospital program in a community hospital setting with 20 hospitalists. Before that, she worked in private practice as a hospitalist. Now, when she talks with residents, she talks about their options.

“It’s really important that you figure out what kind of setting you want,” Dr. Patel says. “Hospital medicine has a diversity of settings, from a small community hospital where you do a broad range of inpatient care to a larger academic teaching environment or a private practice group.”

Leadership Opportunities

The continuing demand for hospitalists affords young physicians who are considering an HM career additional freedom in the job market. In comparison to more traditional primary-care models, hospitalist jobs offer flexible hours and competitive salaries.

Dr. Chacko points to another benefit that is a direct result of the high demand for hospitalists: increased opportunities to launch management careers. The average age of a hospitalist is 37 and the average age of an HM group leader is 41, according to SHM’s 2007-2008 Bi-Annual Survey on the State of the Hospital Medicine Movement.

 

“That’s not that much of a difference,” Dr. Chacko says. “Early-career hospitalists find ample leadership opportunities in the specialty. There are lots of opportunities for young hospitalists.”

How to Get Started

Because most teaching hospitals have hospitalists, most residents are exposed to HM. Many hospitalists relish the opportunity to mentor and provide early-career counseling. “Sometimes, a resident will ask to grab coffee and learn more about hospital medicine,” Dr. Huang says. “I tell them what my job is like. Many ask, ‘How do I get started looking for a job?’ I tell them that connections really help. Word of mouth is very important, so I refer people to other people.”

Margaret Fang, MD, MPH, FHM, assistant professor of medicine at the University of California at San Francisco’s division of hospital medicine and a founding member of the Young Physicians Committee, recommends that residents begin with a vision and work backward. “On a broad level, if you’re a resident, you should think about where you want to be in five years,” she says. “Look around your hospital and find a few people whose job you want.”

For some young physicians, looking ahead five years could mean being part of the healthcare revolution of tomorrow. TH

Brendon Shank is a freelance writer based in Philadelphia.

SHM elects board members

SHM has elected three new members to its Board of Directors and re-elected two members. Board members are nominated and elected by the membership and serve a three-year term.The newly elected members of the board are:

Eric Howell, MD, FHM, associate professor of medicine at Johns Hopkins University School of Medicine and director of the hospitalist division and hospital care at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Howell is a member of the Leadership Academy faculty and received the 2009 Award for Excellence in Teaching.

 

Burke Kealey, MD, FHM, assistant medical director of Health Partners Medical Group in Minneapolis and adjunct assistant professor of internal medicine at the University of Minnesota. Dr. Kealey has been an active member of SHM for more than 10 years and earned the society’s 2003 Award for Clinical Excellence.

 

 

Dan Dressler, MD, MSc, FHM, director of education at Emory University School of Medicine in Atlanta. A member of SHM’s Education Committee and Leadership Academy faculty, Dr. Dressler received Emory’s Hospital Medicine Leadership Award in 2006 and Hospital Medicine Teaching Award in 2007.

 

Re-elected board members:

Jeffrey Wiese, MD, FHM, professor of medicine, associate dean for graduate medical education, and associate professor of medicine at Tulane University Health Sciences Center in New Orleans. Dr. Wiese also was voted 2010-2011 board president-elect.

 

Jack Percelay, MD, MPH, FHM, FAAP, pediatric hospitalist with ELMO Pediatrics in New York City. Dr. Percelay was first elected to the board in 2005 and represents pediatric hospitalists.

Younger generations blaze new paths through the American economy. Fifteen years ago, Generation X was fresh out of college and flush with the unimagined potential of the Internet. They helped change the way the world shared information and conducted business. The impact of such innovation and enthusiasm for new technology is still felt today.

The healthcare sector possesses pioneers of its own, many with the same kind of drive and vision as the dot-com entrepreneurs of the 1990s. Fifteen years from now, today’s young hospitalists—shaped by ever-changing demands and healthcare hurdles—will be recognized as an authority in the new ways patient care is delivered.

Bijo Chacko, MD, FHM, former chair of SHM’s Young Physicians Committee, sees energy in the newest generation of hospitalists. He also sees great potential from residents who are finishing their training and considering their job options. Until recently, SHM’s Young Physicians Committee operated as a task force. The group’s growth and increased young-physician representation throughout the society prompted SHM leadership to promote the task force to full committee status.

“The wonderful thing is that we have received lots of input from around the country and dramatically increased membership in the past few years,” says Dr. Chacko, hospital medicine medical director for Preferred Health Partners in New York City. “We have moved from simply gathering information about young physicians in hospital medicine to actively disseminating it, including the new Resident’s Corner [department in The Hospitalist]. It addresses the needs of residents and introduces them to the nuances and specifics of hospital medicine.”

The demand for information has spurred the launch of a young physicians section (www.hospitalmedicine.org/youngdoctor) on SHM’s Web site. Combined with SHM’s online career center (www.hospitalmedicine.org/careercenter), the new microsites provide young physicians a broad range of information about the specialty and—most importantly—HM career options.

Natural Progression

Four out of five large hospitals now use hospitalists, and as more hospitals implement HM programs, more residents will be exposed to the hospitalist model of care. For residents, the allure of an HM career is broad and deep. In many ways, HM is the logical extension of residency training. Brian Markoff, MD, FHM, a hospitalist and associate professor of medicine at Mount Sinai Hospitalist Group in New York City, was a chief resident when he founded the hospitalist program at the University of California at Davis Health System in Sacramento in 1998.

 

“Creating the hospitalist program at UC-Davis was pretty easy,” Dr. Markoff says. “All of the program’s founders were chief residents at the time. The people involved were warm to the idea, and we could teach without being in the fellowship program. Residents are already very comfortable treating patients in the hospital setting.”

Dr. Markoff says practicing hospitalists are a positive influence on residents who are still undecided on a career path. “If you’re a good role model, they’ll be interested in hospital medicine,” he says.

Diversity of Patients, Issues, Settings

Dr. Markoff and others caution that HM encompasses more than an expansion of a resident’s standard roles and responsibilities. “We’re not just super-residents,” he says. “We’re highly trained specialists in the care of hospitalized patients and the process of making care in hospital better.”

Medical conditions, patient issues, and administrative situations that often are outside a resident’s scope quickly come into focus for a new hospitalist. When Mona Patel, DO, associate director of hospitalist services at Staten Island University Hospital in New York, chose an HM career five years ago, the diversity in opportunities was a major draw. Like many hospitalists, she knew she would enjoy the type of care she provides to patients.

“I liked the acuity of the patients and disease processes; it was much more interesting and exciting for me than ongoing outpatient care of chronic diseases,” Dr. Patel says. “I liked the interaction with the hospital house staff and lots of consultants. If I had questions about a patient, I could easily consult with a specialist within the hospital.”

In addition to providing bedside care, new hospitalists often find themselves at the forefront of a monumental change in how healthcare is provided nationwide. Quality improvement (QI) initiatives, such as reducing preventable diseases in the hospital and reducing readmission rates, attracted Bryan Huang, MD, to hospital medicine at the University of California at San Diego.

“When I interviewed at UCSD, I was very interested in quality improvement,” says Dr. Huang, an assistant clinical professor at UCSD’s Division of Hospital Medicine. “UCSD is well known for glycemic control and VTE prophylaxis. We’re now working on quality improvement for treating delirium and hospital discharge.”

His experience as an academic hospitalist has opened up the QI world to him. “Before this job, I was almost not familiar at all with quality improvement,” Dr. Huang says. “As a resident, I did some quality-improvement work, but not much. Quality improvement was missing from residency training, but it’s getting better.”

Dr. Patel says HM’s biggest selling point is the variety of settings available to a new hospitalist. She’s been working for the past two years in an academic hospital program in a community hospital setting with 20 hospitalists. Before that, she worked in private practice as a hospitalist. Now, when she talks with residents, she talks about their options.

“It’s really important that you figure out what kind of setting you want,” Dr. Patel says. “Hospital medicine has a diversity of settings, from a small community hospital where you do a broad range of inpatient care to a larger academic teaching environment or a private practice group.”

Leadership Opportunities

The continuing demand for hospitalists affords young physicians who are considering an HM career additional freedom in the job market. In comparison to more traditional primary-care models, hospitalist jobs offer flexible hours and competitive salaries.

Dr. Chacko points to another benefit that is a direct result of the high demand for hospitalists: increased opportunities to launch management careers. The average age of a hospitalist is 37 and the average age of an HM group leader is 41, according to SHM’s 2007-2008 Bi-Annual Survey on the State of the Hospital Medicine Movement.

 

“That’s not that much of a difference,” Dr. Chacko says. “Early-career hospitalists find ample leadership opportunities in the specialty. There are lots of opportunities for young hospitalists.”

How to Get Started

Because most teaching hospitals have hospitalists, most residents are exposed to HM. Many hospitalists relish the opportunity to mentor and provide early-career counseling. “Sometimes, a resident will ask to grab coffee and learn more about hospital medicine,” Dr. Huang says. “I tell them what my job is like. Many ask, ‘How do I get started looking for a job?’ I tell them that connections really help. Word of mouth is very important, so I refer people to other people.”

Margaret Fang, MD, MPH, FHM, assistant professor of medicine at the University of California at San Francisco’s division of hospital medicine and a founding member of the Young Physicians Committee, recommends that residents begin with a vision and work backward. “On a broad level, if you’re a resident, you should think about where you want to be in five years,” she says. “Look around your hospital and find a few people whose job you want.”

For some young physicians, looking ahead five years could mean being part of the healthcare revolution of tomorrow. TH

Brendon Shank is a freelance writer based in Philadelphia.

SHM elects board members

SHM has elected three new members to its Board of Directors and re-elected two members. Board members are nominated and elected by the membership and serve a three-year term.The newly elected members of the board are:

Eric Howell, MD, FHM, associate professor of medicine at Johns Hopkins University School of Medicine and director of the hospitalist division and hospital care at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Howell is a member of the Leadership Academy faculty and received the 2009 Award for Excellence in Teaching.

 

Burke Kealey, MD, FHM, assistant medical director of Health Partners Medical Group in Minneapolis and adjunct assistant professor of internal medicine at the University of Minnesota. Dr. Kealey has been an active member of SHM for more than 10 years and earned the society’s 2003 Award for Clinical Excellence.

 

 

Dan Dressler, MD, MSc, FHM, director of education at Emory University School of Medicine in Atlanta. A member of SHM’s Education Committee and Leadership Academy faculty, Dr. Dressler received Emory’s Hospital Medicine Leadership Award in 2006 and Hospital Medicine Teaching Award in 2007.

 

Re-elected board members:

Jeffrey Wiese, MD, FHM, professor of medicine, associate dean for graduate medical education, and associate professor of medicine at Tulane University Health Sciences Center in New Orleans. Dr. Wiese also was voted 2010-2011 board president-elect.

 

Jack Percelay, MD, MPH, FHM, FAAP, pediatric hospitalist with ELMO Pediatrics in New York City. Dr. Percelay was first elected to the board in 2005 and represents pediatric hospitalists.