Nosocomial, or hospital‐acquired, infections (HAIs) are a major cause of patient morbidity and mortality in the United States and other countries.15 In 2002, approximately 1.7 million HAIs occurred in US hospitals and were associated with an estimated 98,987 deaths.1 Of particular note, increasing percentages of HAIs are now caused by antimicrobial‐resistant pathogens, which have been linked with increases in morbidity, mortality, length of hospital stay, and healthcare costs.6

The 2004 data summary from the United States National Nosocomial Infections Surveillance (NNIS) System Report highlighted substantial increases for year 2003 versus 1998 through 2002 in vancomycin‐resistant enterococci (VRE); methicillin‐resistant Staphylococcus aureus; Klebsiella pneumoniae resistant to third‐generation cephalosporins; and Pseudomonas aeruginosa resistant to imipenem, quinolones, or third‐generation cephalosporins.7 Other gram‐negative bacteria of concern include Escherichia coli and Acinetobacter baumannii, as well as Enterobacter cloacae and E. aerogenes.8, 9

The increasing number of multidrug‐resistant (MDR) gram‐negative bacteria within the healthcare setting is particularly concerning.1013 Too frequently, clinicians in the United States now encounter gram‐negative bacteria species that are resistant to many, and occasionally all, currently available antibiotics. For many of these MDR gram‐negative pathogens the antimicrobials that potentially remain active (eg, aminoglycosides and polymyxins) are often more toxic and less efficacious for some infections.14 Particularly problematic is that the pharmaceutical industry's developmental pipeline for new antibiotics, with novel mechanisms of action that might be used against MDR gram‐negative pathogens, has virtually come to a standstill.15, 16 Even if an investigational drug was in phase 2 or 3 trials right now or entered the US Food and Drug Administration (FDA) Fast Track Development Program, it would be at least 10 or 15 years before that drug would be available on the US market.

What this means is that the clinician's current antibiotic armamentarium is all they can expect in the foreseeable future. It also means that special care needs to be taken to optimally use currently available agents to ensure continued activity against the pathogens encountered in the hospital (and community) setting, now and in the future. Maximizing clinical outcomes, while minimizing the emergence and spread of antimicrobial resistance (and other adverse effects associated with suboptimal antimicrobial drug use), falls under the purview of antimicrobial stewardship, the focus of this paper.

Antimicrobial StewardshipWhy Is It Needed, What Is It, and What Are Its Goals?

Constructing an Antimicrobial Stewardship Program

A Case Study: the Wake Forest University Baptist Medical Center (WFUBMC) Program

Figure 1A,B provides an overview of the general structure of the antimicrobial stewardship program at WFUBMC implemented in 2000. To establish and provide the information needed for day‐to‐day operations of a stewardship program at WFUBMC, data are needed on how, where, and by whom antibiotics are used within the institution. In addition, microbiology data, including the frequency and susceptibility of infecting pathogens, are essential. Obtaining these data often requires the help and cooperation of the information technology (IT) staff at the institution. Considerable time and effort may be required at the outset, but once information system programs are established, ongoing data mining is much easier. At the time of program initiation, it was decided to assess antibiotic use or density (amount of drug per inpatient geographic unit) using the defined‐daily‐dose (DDD) method. This entails assigning a predetermined weight of administered antibiotic as a dose and dividing by a denominator of 1000 patient days. Subsequently, days of therapy per drug has been found to be a more accurate measure of antimicrobial consumption. When developing a program, it is vital to first obtain baseline usage data. Such data should include, if possible, a detailed inventory of usage within different units of the hospital or for particular services, or sometimes even for a particular provider with a history of high antimicrobial usage. Ongoing measurement over time allows the impact of new stewardship interventions and guidelines to be measured, as well as identifying potential new problem areas in usage.

Figure 1

Good microbiology data are also essential to determine problem pathogens at the institution and where they are located. Such data are useful not only to define areas of resistance (potentially warranting changes in antimicrobial policies to alter selection pressures), but also for gathering information necessary for defining local guidelines for antimicrobial use. For example, if the local antibiograms show that a particular pathogen in the hospital ICU has a particular resistance pattern, then initial empiric therapy for patients at risk of infection with those organisms should be chosen to cover the problematic resistant pathogen. Once subsequent microbiology data become available, patients not infected with the pathogen can be de‐escalated to a more narrow‐spectrum antibiotic.

As illustrated in Figure 1A, at WFUBMC, all the collected data are integrated to provide information concerning antibiotic density, usage, and patterns of antimicrobial resistance. This information is received by the staff of the antimicrobial stewardship program, which at WFUBMC is called the Center for Antimicrobial Utilization, Stewardship and Epidemiology (CAUSE). The CAUSE staff works with the day‐to‐day elements of program administration and operations and includes 2 infectious diseases physicians and 2 infectious disease PharmDs. The CAUSE staff works very closely with the microbiology laboratory, hospital pharmacy, and the medical director of hospital epidemiology and infection control.

The CAUSE program at WFUBMC administratively functions through an advisory board committee that includes thought leaders from different medical specialties and patient units of the hospitalparticularly those with high antimicrobial usage, such as hematology/oncology, pulmonary, critical care, and transplantation. The CAUSE staff and advisory board exist to exchange ideas concerning what is working or not working and where problem areas may be, and to propose possible changes in antimicrobial practices at the institution. In addition, thought leaders on the advisory board also receive and evaluate information from various sources about new antimicrobial agents and national guidelines, and, in turn, help disseminate this information to the hospital personnel who will be involved in program implementation.

At WFUBMC, it is the advisory board committee, working in conjunction with the CAUSE staff/medical director, that presents antimicrobials for formulary consideration to the Pharmacy and Therapeutics (P&T) Committee, in addition to any major interventions CAUSE and its advisory board feel are indicated. The P&T committee then reports to the medical staff executive committee and hospital leadership. As should be evident, the approach to stewardship at WFUBMC is medical staff‐driven, rather than a function of administrative constituents.

Finally, no matter how well‐organized an antimicrobial stewardship program is, it will not be fully successful if the entire medical staff does not buy into the process and agree with the need for the proposed changes and interventions involving the practice of antimicrobial therapy. It is important to spend some time early in program development to ensure that the need for an antimicrobial stewardship program, the process, and the outcomes (both in terms of patient care and clinical outcomes at the institution) are clearly communicated to the medical staff, and that their full commitment and cooperation are enlisted. In cases where hospital‐wide infection or resistance rates are known and antimicrobial utilization data are available, it is important to present such information in an understandable and convincing manner that makes the case for a proposed change or intervention, not only at the hospital level but also at the level of the patient.

Elements of a Successful Program: Basic Strategies

Potential strategies or elements of an antimicrobial stewardship program are listed in Table 2. Two evidence‐based fundamental or core strategies have been recommended by the IDSA/SHEA guidelines24 and implemented at numerous institutions with various levels of success. The first is a so‐called back‐end approach to modifying antimicrobial therapy on the basis of prospective audit of antimicrobial use, with intervention and feedback to the provider. The second is a front‐end approach using formulary restriction and preauthorization requirements for specific antimicrobial agents. Various supplemental strategies, including large group and patient case‐based education, guidelines and clinical pathways, antimicrobial order forms, and computerized clinical decision support, are also recommended.

Prospective Audit With Intervention and Feedback

This approach usually involves the use of an antimicrobial support team that reviews initial or ongoing therapy and then intervenes to provide feedback and suggested modifications to the medical care provider to improve therapy. This can be done by an infectious diseases physician, a clinical pharmacist, or a hospitalist or internist with expertise in antimicrobial therapy. The aim is to provide patient‐specific education and/or suggest changes to antimicrobial utilization (when needed) to improve and streamline therapy. Suggested interventions could include discontinuing or changing 1 or more drugs, switching intravenous to oral drug administration, and suggesting a short‐course duration of therapy. Occasionally, suggestions are made when appropriate to actually escalate or intensify therapy to increase efficacy. Identification of patients for targeting or focusing prospective audit and feedback efforts typically involves using computer surveillance to single out problem antimicrobials or problematic usage, given local resistance patterns or patient characteristics.24 Examples could include a focus on asymptomatic bacteruria, excessive duration of therapy for ventilator‐associated pneumonia, or overzealous use of certain classes of antimicrobials. Another potential activity for a prospective audit and feedback team is to review reports of patient‐specific blood and sterile body fluid culture results matched to the patient's current antimicrobial therapy. This allows for daily review of the appropriateness of therapy for potentially serious infections. Some patients seen by the antibiotic support team may be referred for infectious diseases or other expert consultative opinion if their infections or therapy are felt to be too complicated for routine prospective audit and feedback recommendations.

A number of studies have demonstrated that strategies involving prospective audit with intervention and feedback can improve antibiotic stewardship, as measured by reductions in inappropriate antibiotic use,30 reduced antibiotic costs or overall consumption,3135 greater compliance with hospital treatment guidelines or policies33, 36, 37 and, in some cases, reduced number of infections due to C difficile infection32, 37 or resistant pathogens.31, 32, 37 Prospective audit with feedback is probably the best and most effective core strategy for a community hospital program where other interventions are cumbersome or not as well tolerated by the medical staff. One potential disadvantage of the prospective audit with intervention and feedback approach is that medical provider adherence is largely voluntary. The team can make suggestions, but if the provider disagrees or is unobtainable, the suggestion is never implemented. Also, this strategy can also be resource‐intensive from a personnel perspective.

Evaluating Antimicrobial Stewardship Programs

Two general types of measures are used to evaluate the effectiveness of antimicrobial stewardship: process and outcome. As with most things done in the hospital, process measures are easier. They measure surrogate impacts of a program, accountability, resource use, and cost effectiveness. In essence, process measures evaluate whether the program accomplished what it set out to do in terms of changing certain processes or prescriber behaviors. It is important to measure resource use, as this helps to continue funding and to keep workers involved in the project. Good programs will save money; this can easily be measured, even if it is just as simple as going to the hospital pharmacy and looking at the cost of antimicrobials provided per patient day.

Outcomes like decreases in particular infections, less emergence of antimicrobial resistance, or other patient‐specific measures are likely more important in the big picture, but they are also much more difficult to measure. For example, where one would like to measure changes in pathogen resistance after making some changes in antimicrobial stewardship, it often takes years before the benefits of a particular intervention or change materialize in terms of less resistance or reduced emergence of resistance. If that type of change is to be measured, then one needs to be persistent and continue measurements over a long period of time. In addition, given the protracted amount of time before these outcomes may be observed, a number of other changes are likely to happen that coincide with the antimicrobial stewardship interventions and make assessment of causality difficult and biased.

Having said that, a number of studies have demonstrated a relationship between antibiotic restriction48, 8285 or other antimicrobial stewardship policies32, 86 and decreases in nosocomial C difficile infections or disease. Figure 2 illustrates the impact of a nonrestrictive antimicrobial stewardship program at a secondary/tertiary‐care hospital in Quebec, Canada, on an epidemic of C difficileassociated disease (CDAD) that occurred at the institution during the latter portion of 2003.86 Following program implementation, and the major drop in targeted antibiotic consumption, the incidence of CDAD also significantly decreased. Earlier implementation of infection control measures had no effect on CDAD incidence.

Figure 2

A smaller number of studies have reported decreases in resistant gram‐negative bacteria following implementation of antimicrobial stewardship programs. For example, Meyer and colleagues reported a marked reduction in ceftazidime‐resistant K pneumoniae at a 487‐bed general hospital in New York City after implementation of enhanced ceftazidime restriction and barrier precautions following an outbreak of infections caused by the resistant K pneumoniae.87 Similarly, Carling and coworkers reported a significant decrease in nosocomial infections caused by resistant Enterobacteriaceae following implementation of a multidisciplinary antibiotic stewardship program to minimize inappropriate use of third‐generation cephalosporins (Figure 3).32 More recently, a retrospective, longitudinal, multicenter analysis of a consortium of 22 academic health centers in the United States showed that incidence rates of carbapenem‐resistant P aeruginosa were lower at hospitals that restricted carbapenems than those that did not (P = .01).88

Figure 3

Evidence suggesting a beneficial impact of antimicrobial stewardship programs on resistance in gram‐positive organisms is limited. More specifically, the study by Carling and colleagues reported an apparent decrease in VRE rates following implementation of their program to reduce inappropriate use of third‐generation cephalosporins.32 The hospital had VRE rates similar to other NNIS System hospitals prior to beginning the program, but after antibiotic stewardship measures were implemented, the VRE rate began to drop, falling to 6% by 1999. This should be compared with a VRE rate of 24% for similar NNIS System hospitals in 1999.

As far as reducing healthcare costs, Figure 4A illustrates the direct antimicrobial cost savings at WFUBMC after implementation of the CAUSE antimicrobial stewardship program, and Figure 4B after supplemental interventions were implemented. Although decreasing antimicrobial cost is important, one would like to show decreases in overall healthcare costs associated with an antimicrobial stewardship program. Unfortunately, this is often a little more difficult to demonstrate. Extrapolations, however, may be possible. Because antimicrobial resistance, adverse drug effects, and secondary unintended infections such as C difficile colitis have been linked with increased patient morbidity and mortality, longer hospital stays, and increased healthcare costs,6, 89, 90 improved antimicrobial stewardship is expected to optimize patient care and lower overall healthcare costs. A study in a large tertiary care academic medical center estimated more than $4.25 million in total healthcare savings over 1 year with a stewardship program using both preauthorization and, to a lesser extent, prospective audit and feedback.91 Despite the fact cost saving should not be a primary goal of an antimicrobial stewardship program, lower antimicrobial costs can help keep a program funded and buttress a proposal for an antimicrobial stewardship program to hospital leadership.

Figure 4

Many hospitals recognize other areas where an antimicrobial stewardship program can demonstrate its value. This includes implementation of a rapid change in drug utilization during antimicrobial supply shortages and assistance with regulatory mandates and surgical infection prophylaxis. Stewardship teams often assist microbiology with protocols for microbiology reporting, antibiograms, planning for susceptibility testing, and communicating changes in microbiology tests or protocols to clinicians.

Conclusions

Overuse or misuse of antibiotics and other antimicrobials for hospital inpatients is relatively common, and can be associated with several unintended negative consequences. Improving medical care necessarily includes better use of antimicrobials to optimize outcomes and preserve the effectiveness of currently available agents. Further, an important additional consequence of effective antimicrobial stewardship and improved patient care is typically a lowering of overall healthcare costs. The recent 2007 IDSA/SHEA guidelines provide recommendations for developing an institutional program to enhance antimicrobial stewardship. However, individual institutions need to look closely at their own systems and patients to develop an antimicrobial stewardship program that best serves the needs of their hospital and the people it serves.

Nosocomial, or hospital‐acquired, infections (HAIs) are a major cause of patient morbidity and mortality in the United States and other countries.15 In 2002, approximately 1.7 million HAIs occurred in US hospitals and were associated with an estimated 98,987 deaths.1 Of particular note, increasing percentages of HAIs are now caused by antimicrobial‐resistant pathogens, which have been linked with increases in morbidity, mortality, length of hospital stay, and healthcare costs.6

The 2004 data summary from the United States National Nosocomial Infections Surveillance (NNIS) System Report highlighted substantial increases for year 2003 versus 1998 through 2002 in vancomycin‐resistant enterococci (VRE); methicillin‐resistant Staphylococcus aureus; Klebsiella pneumoniae resistant to third‐generation cephalosporins; and Pseudomonas aeruginosa resistant to imipenem, quinolones, or third‐generation cephalosporins.7 Other gram‐negative bacteria of concern include Escherichia coli and Acinetobacter baumannii, as well as Enterobacter cloacae and E. aerogenes.8, 9

The increasing number of multidrug‐resistant (MDR) gram‐negative bacteria within the healthcare setting is particularly concerning.1013 Too frequently, clinicians in the United States now encounter gram‐negative bacteria species that are resistant to many, and occasionally all, currently available antibiotics. For many of these MDR gram‐negative pathogens the antimicrobials that potentially remain active (eg, aminoglycosides and polymyxins) are often more toxic and less efficacious for some infections.14 Particularly problematic is that the pharmaceutical industry's developmental pipeline for new antibiotics, with novel mechanisms of action that might be used against MDR gram‐negative pathogens, has virtually come to a standstill.15, 16 Even if an investigational drug was in phase 2 or 3 trials right now or entered the US Food and Drug Administration (FDA) Fast Track Development Program, it would be at least 10 or 15 years before that drug would be available on the US market.

What this means is that the clinician's current antibiotic armamentarium is all they can expect in the foreseeable future. It also means that special care needs to be taken to optimally use currently available agents to ensure continued activity against the pathogens encountered in the hospital (and community) setting, now and in the future. Maximizing clinical outcomes, while minimizing the emergence and spread of antimicrobial resistance (and other adverse effects associated with suboptimal antimicrobial drug use), falls under the purview of antimicrobial stewardship, the focus of this paper.

Antimicrobial StewardshipWhy Is It Needed, What Is It, and What Are Its Goals?

Constructing an Antimicrobial Stewardship Program

A Case Study: the Wake Forest University Baptist Medical Center (WFUBMC) Program

Figure 1A,B provides an overview of the general structure of the antimicrobial stewardship program at WFUBMC implemented in 2000. To establish and provide the information needed for day‐to‐day operations of a stewardship program at WFUBMC, data are needed on how, where, and by whom antibiotics are used within the institution. In addition, microbiology data, including the frequency and susceptibility of infecting pathogens, are essential. Obtaining these data often requires the help and cooperation of the information technology (IT) staff at the institution. Considerable time and effort may be required at the outset, but once information system programs are established, ongoing data mining is much easier. At the time of program initiation, it was decided to assess antibiotic use or density (amount of drug per inpatient geographic unit) using the defined‐daily‐dose (DDD) method. This entails assigning a predetermined weight of administered antibiotic as a dose and dividing by a denominator of 1000 patient days. Subsequently, days of therapy per drug has been found to be a more accurate measure of antimicrobial consumption. When developing a program, it is vital to first obtain baseline usage data. Such data should include, if possible, a detailed inventory of usage within different units of the hospital or for particular services, or sometimes even for a particular provider with a history of high antimicrobial usage. Ongoing measurement over time allows the impact of new stewardship interventions and guidelines to be measured, as well as identifying potential new problem areas in usage.

Figure 1

Good microbiology data are also essential to determine problem pathogens at the institution and where they are located. Such data are useful not only to define areas of resistance (potentially warranting changes in antimicrobial policies to alter selection pressures), but also for gathering information necessary for defining local guidelines for antimicrobial use. For example, if the local antibiograms show that a particular pathogen in the hospital ICU has a particular resistance pattern, then initial empiric therapy for patients at risk of infection with those organisms should be chosen to cover the problematic resistant pathogen. Once subsequent microbiology data become available, patients not infected with the pathogen can be de‐escalated to a more narrow‐spectrum antibiotic.

As illustrated in Figure 1A, at WFUBMC, all the collected data are integrated to provide information concerning antibiotic density, usage, and patterns of antimicrobial resistance. This information is received by the staff of the antimicrobial stewardship program, which at WFUBMC is called the Center for Antimicrobial Utilization, Stewardship and Epidemiology (CAUSE). The CAUSE staff works with the day‐to‐day elements of program administration and operations and includes 2 infectious diseases physicians and 2 infectious disease PharmDs. The CAUSE staff works very closely with the microbiology laboratory, hospital pharmacy, and the medical director of hospital epidemiology and infection control.

The CAUSE program at WFUBMC administratively functions through an advisory board committee that includes thought leaders from different medical specialties and patient units of the hospitalparticularly those with high antimicrobial usage, such as hematology/oncology, pulmonary, critical care, and transplantation. The CAUSE staff and advisory board exist to exchange ideas concerning what is working or not working and where problem areas may be, and to propose possible changes in antimicrobial practices at the institution. In addition, thought leaders on the advisory board also receive and evaluate information from various sources about new antimicrobial agents and national guidelines, and, in turn, help disseminate this information to the hospital personnel who will be involved in program implementation.

At WFUBMC, it is the advisory board committee, working in conjunction with the CAUSE staff/medical director, that presents antimicrobials for formulary consideration to the Pharmacy and Therapeutics (P&T) Committee, in addition to any major interventions CAUSE and its advisory board feel are indicated. The P&T committee then reports to the medical staff executive committee and hospital leadership. As should be evident, the approach to stewardship at WFUBMC is medical staff‐driven, rather than a function of administrative constituents.

Finally, no matter how well‐organized an antimicrobial stewardship program is, it will not be fully successful if the entire medical staff does not buy into the process and agree with the need for the proposed changes and interventions involving the practice of antimicrobial therapy. It is important to spend some time early in program development to ensure that the need for an antimicrobial stewardship program, the process, and the outcomes (both in terms of patient care and clinical outcomes at the institution) are clearly communicated to the medical staff, and that their full commitment and cooperation are enlisted. In cases where hospital‐wide infection or resistance rates are known and antimicrobial utilization data are available, it is important to present such information in an understandable and convincing manner that makes the case for a proposed change or intervention, not only at the hospital level but also at the level of the patient.

Elements of a Successful Program: Basic Strategies

Potential strategies or elements of an antimicrobial stewardship program are listed in Table 2. Two evidence‐based fundamental or core strategies have been recommended by the IDSA/SHEA guidelines24 and implemented at numerous institutions with various levels of success. The first is a so‐called back‐end approach to modifying antimicrobial therapy on the basis of prospective audit of antimicrobial use, with intervention and feedback to the provider. The second is a front‐end approach using formulary restriction and preauthorization requirements for specific antimicrobial agents. Various supplemental strategies, including large group and patient case‐based education, guidelines and clinical pathways, antimicrobial order forms, and computerized clinical decision support, are also recommended.

Prospective Audit With Intervention and Feedback

This approach usually involves the use of an antimicrobial support team that reviews initial or ongoing therapy and then intervenes to provide feedback and suggested modifications to the medical care provider to improve therapy. This can be done by an infectious diseases physician, a clinical pharmacist, or a hospitalist or internist with expertise in antimicrobial therapy. The aim is to provide patient‐specific education and/or suggest changes to antimicrobial utilization (when needed) to improve and streamline therapy. Suggested interventions could include discontinuing or changing 1 or more drugs, switching intravenous to oral drug administration, and suggesting a short‐course duration of therapy. Occasionally, suggestions are made when appropriate to actually escalate or intensify therapy to increase efficacy. Identification of patients for targeting or focusing prospective audit and feedback efforts typically involves using computer surveillance to single out problem antimicrobials or problematic usage, given local resistance patterns or patient characteristics.24 Examples could include a focus on asymptomatic bacteruria, excessive duration of therapy for ventilator‐associated pneumonia, or overzealous use of certain classes of antimicrobials. Another potential activity for a prospective audit and feedback team is to review reports of patient‐specific blood and sterile body fluid culture results matched to the patient's current antimicrobial therapy. This allows for daily review of the appropriateness of therapy for potentially serious infections. Some patients seen by the antibiotic support team may be referred for infectious diseases or other expert consultative opinion if their infections or therapy are felt to be too complicated for routine prospective audit and feedback recommendations.

A number of studies have demonstrated that strategies involving prospective audit with intervention and feedback can improve antibiotic stewardship, as measured by reductions in inappropriate antibiotic use,30 reduced antibiotic costs or overall consumption,3135 greater compliance with hospital treatment guidelines or policies33, 36, 37 and, in some cases, reduced number of infections due to C difficile infection32, 37 or resistant pathogens.31, 32, 37 Prospective audit with feedback is probably the best and most effective core strategy for a community hospital program where other interventions are cumbersome or not as well tolerated by the medical staff. One potential disadvantage of the prospective audit with intervention and feedback approach is that medical provider adherence is largely voluntary. The team can make suggestions, but if the provider disagrees or is unobtainable, the suggestion is never implemented. Also, this strategy can also be resource‐intensive from a personnel perspective.

Evaluating Antimicrobial Stewardship Programs

Two general types of measures are used to evaluate the effectiveness of antimicrobial stewardship: process and outcome. As with most things done in the hospital, process measures are easier. They measure surrogate impacts of a program, accountability, resource use, and cost effectiveness. In essence, process measures evaluate whether the program accomplished what it set out to do in terms of changing certain processes or prescriber behaviors. It is important to measure resource use, as this helps to continue funding and to keep workers involved in the project. Good programs will save money; this can easily be measured, even if it is just as simple as going to the hospital pharmacy and looking at the cost of antimicrobials provided per patient day.

Outcomes like decreases in particular infections, less emergence of antimicrobial resistance, or other patient‐specific measures are likely more important in the big picture, but they are also much more difficult to measure. For example, where one would like to measure changes in pathogen resistance after making some changes in antimicrobial stewardship, it often takes years before the benefits of a particular intervention or change materialize in terms of less resistance or reduced emergence of resistance. If that type of change is to be measured, then one needs to be persistent and continue measurements over a long period of time. In addition, given the protracted amount of time before these outcomes may be observed, a number of other changes are likely to happen that coincide with the antimicrobial stewardship interventions and make assessment of causality difficult and biased.

Having said that, a number of studies have demonstrated a relationship between antibiotic restriction48, 8285 or other antimicrobial stewardship policies32, 86 and decreases in nosocomial C difficile infections or disease. Figure 2 illustrates the impact of a nonrestrictive antimicrobial stewardship program at a secondary/tertiary‐care hospital in Quebec, Canada, on an epidemic of C difficileassociated disease (CDAD) that occurred at the institution during the latter portion of 2003.86 Following program implementation, and the major drop in targeted antibiotic consumption, the incidence of CDAD also significantly decreased. Earlier implementation of infection control measures had no effect on CDAD incidence.

Figure 2

A smaller number of studies have reported decreases in resistant gram‐negative bacteria following implementation of antimicrobial stewardship programs. For example, Meyer and colleagues reported a marked reduction in ceftazidime‐resistant K pneumoniae at a 487‐bed general hospital in New York City after implementation of enhanced ceftazidime restriction and barrier precautions following an outbreak of infections caused by the resistant K pneumoniae.87 Similarly, Carling and coworkers reported a significant decrease in nosocomial infections caused by resistant Enterobacteriaceae following implementation of a multidisciplinary antibiotic stewardship program to minimize inappropriate use of third‐generation cephalosporins (Figure 3).32 More recently, a retrospective, longitudinal, multicenter analysis of a consortium of 22 academic health centers in the United States showed that incidence rates of carbapenem‐resistant P aeruginosa were lower at hospitals that restricted carbapenems than those that did not (P = .01).88

Figure 3

Evidence suggesting a beneficial impact of antimicrobial stewardship programs on resistance in gram‐positive organisms is limited. More specifically, the study by Carling and colleagues reported an apparent decrease in VRE rates following implementation of their program to reduce inappropriate use of third‐generation cephalosporins.32 The hospital had VRE rates similar to other NNIS System hospitals prior to beginning the program, but after antibiotic stewardship measures were implemented, the VRE rate began to drop, falling to 6% by 1999. This should be compared with a VRE rate of 24% for similar NNIS System hospitals in 1999.

As far as reducing healthcare costs, Figure 4A illustrates the direct antimicrobial cost savings at WFUBMC after implementation of the CAUSE antimicrobial stewardship program, and Figure 4B after supplemental interventions were implemented. Although decreasing antimicrobial cost is important, one would like to show decreases in overall healthcare costs associated with an antimicrobial stewardship program. Unfortunately, this is often a little more difficult to demonstrate. Extrapolations, however, may be possible. Because antimicrobial resistance, adverse drug effects, and secondary unintended infections such as C difficile colitis have been linked with increased patient morbidity and mortality, longer hospital stays, and increased healthcare costs,6, 89, 90 improved antimicrobial stewardship is expected to optimize patient care and lower overall healthcare costs. A study in a large tertiary care academic medical center estimated more than $4.25 million in total healthcare savings over 1 year with a stewardship program using both preauthorization and, to a lesser extent, prospective audit and feedback.91 Despite the fact cost saving should not be a primary goal of an antimicrobial stewardship program, lower antimicrobial costs can help keep a program funded and buttress a proposal for an antimicrobial stewardship program to hospital leadership.

Figure 4

Many hospitals recognize other areas where an antimicrobial stewardship program can demonstrate its value. This includes implementation of a rapid change in drug utilization during antimicrobial supply shortages and assistance with regulatory mandates and surgical infection prophylaxis. Stewardship teams often assist microbiology with protocols for microbiology reporting, antibiograms, planning for susceptibility testing, and communicating changes in microbiology tests or protocols to clinicians.

Conclusions

Overuse or misuse of antibiotics and other antimicrobials for hospital inpatients is relatively common, and can be associated with several unintended negative consequences. Improving medical care necessarily includes better use of antimicrobials to optimize outcomes and preserve the effectiveness of currently available agents. Further, an important additional consequence of effective antimicrobial stewardship and improved patient care is typically a lowering of overall healthcare costs. The recent 2007 IDSA/SHEA guidelines provide recommendations for developing an institutional program to enhance antimicrobial stewardship. However, individual institutions need to look closely at their own systems and patients to develop an antimicrobial stewardship program that best serves the needs of their hospital and the people it serves.

Nosocomial, or hospital‐acquired, infections (HAIs) are a major cause of patient morbidity and mortality in the United States and other countries.15 In 2002, approximately 1.7 million HAIs occurred in US hospitals and were associated with an estimated 98,987 deaths.1 Of particular note, increasing percentages of HAIs are now caused by antimicrobial‐resistant pathogens, which have been linked with increases in morbidity, mortality, length of hospital stay, and healthcare costs.6

The 2004 data summary from the United States National Nosocomial Infections Surveillance (NNIS) System Report highlighted substantial increases for year 2003 versus 1998 through 2002 in vancomycin‐resistant enterococci (VRE); methicillin‐resistant Staphylococcus aureus; Klebsiella pneumoniae resistant to third‐generation cephalosporins; and Pseudomonas aeruginosa resistant to imipenem, quinolones, or third‐generation cephalosporins.7 Other gram‐negative bacteria of concern include Escherichia coli and Acinetobacter baumannii, as well as Enterobacter cloacae and E. aerogenes.8, 9

The increasing number of multidrug‐resistant (MDR) gram‐negative bacteria within the healthcare setting is particularly concerning.1013 Too frequently, clinicians in the United States now encounter gram‐negative bacteria species that are resistant to many, and occasionally all, currently available antibiotics. For many of these MDR gram‐negative pathogens the antimicrobials that potentially remain active (eg, aminoglycosides and polymyxins) are often more toxic and less efficacious for some infections.14 Particularly problematic is that the pharmaceutical industry's developmental pipeline for new antibiotics, with novel mechanisms of action that might be used against MDR gram‐negative pathogens, has virtually come to a standstill.15, 16 Even if an investigational drug was in phase 2 or 3 trials right now or entered the US Food and Drug Administration (FDA) Fast Track Development Program, it would be at least 10 or 15 years before that drug would be available on the US market.

What this means is that the clinician's current antibiotic armamentarium is all they can expect in the foreseeable future. It also means that special care needs to be taken to optimally use currently available agents to ensure continued activity against the pathogens encountered in the hospital (and community) setting, now and in the future. Maximizing clinical outcomes, while minimizing the emergence and spread of antimicrobial resistance (and other adverse effects associated with suboptimal antimicrobial drug use), falls under the purview of antimicrobial stewardship, the focus of this paper.

Antimicrobial StewardshipWhy Is It Needed, What Is It, and What Are Its Goals?

Constructing an Antimicrobial Stewardship Program

A Case Study: the Wake Forest University Baptist Medical Center (WFUBMC) Program

Figure 1A,B provides an overview of the general structure of the antimicrobial stewardship program at WFUBMC implemented in 2000. To establish and provide the information needed for day‐to‐day operations of a stewardship program at WFUBMC, data are needed on how, where, and by whom antibiotics are used within the institution. In addition, microbiology data, including the frequency and susceptibility of infecting pathogens, are essential. Obtaining these data often requires the help and cooperation of the information technology (IT) staff at the institution. Considerable time and effort may be required at the outset, but once information system programs are established, ongoing data mining is much easier. At the time of program initiation, it was decided to assess antibiotic use or density (amount of drug per inpatient geographic unit) using the defined‐daily‐dose (DDD) method. This entails assigning a predetermined weight of administered antibiotic as a dose and dividing by a denominator of 1000 patient days. Subsequently, days of therapy per drug has been found to be a more accurate measure of antimicrobial consumption. When developing a program, it is vital to first obtain baseline usage data. Such data should include, if possible, a detailed inventory of usage within different units of the hospital or for particular services, or sometimes even for a particular provider with a history of high antimicrobial usage. Ongoing measurement over time allows the impact of new stewardship interventions and guidelines to be measured, as well as identifying potential new problem areas in usage.

Figure 1

Good microbiology data are also essential to determine problem pathogens at the institution and where they are located. Such data are useful not only to define areas of resistance (potentially warranting changes in antimicrobial policies to alter selection pressures), but also for gathering information necessary for defining local guidelines for antimicrobial use. For example, if the local antibiograms show that a particular pathogen in the hospital ICU has a particular resistance pattern, then initial empiric therapy for patients at risk of infection with those organisms should be chosen to cover the problematic resistant pathogen. Once subsequent microbiology data become available, patients not infected with the pathogen can be de‐escalated to a more narrow‐spectrum antibiotic.

As illustrated in Figure 1A, at WFUBMC, all the collected data are integrated to provide information concerning antibiotic density, usage, and patterns of antimicrobial resistance. This information is received by the staff of the antimicrobial stewardship program, which at WFUBMC is called the Center for Antimicrobial Utilization, Stewardship and Epidemiology (CAUSE). The CAUSE staff works with the day‐to‐day elements of program administration and operations and includes 2 infectious diseases physicians and 2 infectious disease PharmDs. The CAUSE staff works very closely with the microbiology laboratory, hospital pharmacy, and the medical director of hospital epidemiology and infection control.

The CAUSE program at WFUBMC administratively functions through an advisory board committee that includes thought leaders from different medical specialties and patient units of the hospitalparticularly those with high antimicrobial usage, such as hematology/oncology, pulmonary, critical care, and transplantation. The CAUSE staff and advisory board exist to exchange ideas concerning what is working or not working and where problem areas may be, and to propose possible changes in antimicrobial practices at the institution. In addition, thought leaders on the advisory board also receive and evaluate information from various sources about new antimicrobial agents and national guidelines, and, in turn, help disseminate this information to the hospital personnel who will be involved in program implementation.

At WFUBMC, it is the advisory board committee, working in conjunction with the CAUSE staff/medical director, that presents antimicrobials for formulary consideration to the Pharmacy and Therapeutics (P&T) Committee, in addition to any major interventions CAUSE and its advisory board feel are indicated. The P&T committee then reports to the medical staff executive committee and hospital leadership. As should be evident, the approach to stewardship at WFUBMC is medical staff‐driven, rather than a function of administrative constituents.

Finally, no matter how well‐organized an antimicrobial stewardship program is, it will not be fully successful if the entire medical staff does not buy into the process and agree with the need for the proposed changes and interventions involving the practice of antimicrobial therapy. It is important to spend some time early in program development to ensure that the need for an antimicrobial stewardship program, the process, and the outcomes (both in terms of patient care and clinical outcomes at the institution) are clearly communicated to the medical staff, and that their full commitment and cooperation are enlisted. In cases where hospital‐wide infection or resistance rates are known and antimicrobial utilization data are available, it is important to present such information in an understandable and convincing manner that makes the case for a proposed change or intervention, not only at the hospital level but also at the level of the patient.

Elements of a Successful Program: Basic Strategies

Potential strategies or elements of an antimicrobial stewardship program are listed in Table 2. Two evidence‐based fundamental or core strategies have been recommended by the IDSA/SHEA guidelines24 and implemented at numerous institutions with various levels of success. The first is a so‐called back‐end approach to modifying antimicrobial therapy on the basis of prospective audit of antimicrobial use, with intervention and feedback to the provider. The second is a front‐end approach using formulary restriction and preauthorization requirements for specific antimicrobial agents. Various supplemental strategies, including large group and patient case‐based education, guidelines and clinical pathways, antimicrobial order forms, and computerized clinical decision support, are also recommended.

Prospective Audit With Intervention and Feedback

This approach usually involves the use of an antimicrobial support team that reviews initial or ongoing therapy and then intervenes to provide feedback and suggested modifications to the medical care provider to improve therapy. This can be done by an infectious diseases physician, a clinical pharmacist, or a hospitalist or internist with expertise in antimicrobial therapy. The aim is to provide patient‐specific education and/or suggest changes to antimicrobial utilization (when needed) to improve and streamline therapy. Suggested interventions could include discontinuing or changing 1 or more drugs, switching intravenous to oral drug administration, and suggesting a short‐course duration of therapy. Occasionally, suggestions are made when appropriate to actually escalate or intensify therapy to increase efficacy. Identification of patients for targeting or focusing prospective audit and feedback efforts typically involves using computer surveillance to single out problem antimicrobials or problematic usage, given local resistance patterns or patient characteristics.24 Examples could include a focus on asymptomatic bacteruria, excessive duration of therapy for ventilator‐associated pneumonia, or overzealous use of certain classes of antimicrobials. Another potential activity for a prospective audit and feedback team is to review reports of patient‐specific blood and sterile body fluid culture results matched to the patient's current antimicrobial therapy. This allows for daily review of the appropriateness of therapy for potentially serious infections. Some patients seen by the antibiotic support team may be referred for infectious diseases or other expert consultative opinion if their infections or therapy are felt to be too complicated for routine prospective audit and feedback recommendations.

A number of studies have demonstrated that strategies involving prospective audit with intervention and feedback can improve antibiotic stewardship, as measured by reductions in inappropriate antibiotic use,30 reduced antibiotic costs or overall consumption,3135 greater compliance with hospital treatment guidelines or policies33, 36, 37 and, in some cases, reduced number of infections due to C difficile infection32, 37 or resistant pathogens.31, 32, 37 Prospective audit with feedback is probably the best and most effective core strategy for a community hospital program where other interventions are cumbersome or not as well tolerated by the medical staff. One potential disadvantage of the prospective audit with intervention and feedback approach is that medical provider adherence is largely voluntary. The team can make suggestions, but if the provider disagrees or is unobtainable, the suggestion is never implemented. Also, this strategy can also be resource‐intensive from a personnel perspective.

Evaluating Antimicrobial Stewardship Programs

Two general types of measures are used to evaluate the effectiveness of antimicrobial stewardship: process and outcome. As with most things done in the hospital, process measures are easier. They measure surrogate impacts of a program, accountability, resource use, and cost effectiveness. In essence, process measures evaluate whether the program accomplished what it set out to do in terms of changing certain processes or prescriber behaviors. It is important to measure resource use, as this helps to continue funding and to keep workers involved in the project. Good programs will save money; this can easily be measured, even if it is just as simple as going to the hospital pharmacy and looking at the cost of antimicrobials provided per patient day.

Outcomes like decreases in particular infections, less emergence of antimicrobial resistance, or other patient‐specific measures are likely more important in the big picture, but they are also much more difficult to measure. For example, where one would like to measure changes in pathogen resistance after making some changes in antimicrobial stewardship, it often takes years before the benefits of a particular intervention or change materialize in terms of less resistance or reduced emergence of resistance. If that type of change is to be measured, then one needs to be persistent and continue measurements over a long period of time. In addition, given the protracted amount of time before these outcomes may be observed, a number of other changes are likely to happen that coincide with the antimicrobial stewardship interventions and make assessment of causality difficult and biased.

Having said that, a number of studies have demonstrated a relationship between antibiotic restriction48, 8285 or other antimicrobial stewardship policies32, 86 and decreases in nosocomial C difficile infections or disease. Figure 2 illustrates the impact of a nonrestrictive antimicrobial stewardship program at a secondary/tertiary‐care hospital in Quebec, Canada, on an epidemic of C difficileassociated disease (CDAD) that occurred at the institution during the latter portion of 2003.86 Following program implementation, and the major drop in targeted antibiotic consumption, the incidence of CDAD also significantly decreased. Earlier implementation of infection control measures had no effect on CDAD incidence.

Figure 2

A smaller number of studies have reported decreases in resistant gram‐negative bacteria following implementation of antimicrobial stewardship programs. For example, Meyer and colleagues reported a marked reduction in ceftazidime‐resistant K pneumoniae at a 487‐bed general hospital in New York City after implementation of enhanced ceftazidime restriction and barrier precautions following an outbreak of infections caused by the resistant K pneumoniae.87 Similarly, Carling and coworkers reported a significant decrease in nosocomial infections caused by resistant Enterobacteriaceae following implementation of a multidisciplinary antibiotic stewardship program to minimize inappropriate use of third‐generation cephalosporins (Figure 3).32 More recently, a retrospective, longitudinal, multicenter analysis of a consortium of 22 academic health centers in the United States showed that incidence rates of carbapenem‐resistant P aeruginosa were lower at hospitals that restricted carbapenems than those that did not (P = .01).88

Figure 3

Evidence suggesting a beneficial impact of antimicrobial stewardship programs on resistance in gram‐positive organisms is limited. More specifically, the study by Carling and colleagues reported an apparent decrease in VRE rates following implementation of their program to reduce inappropriate use of third‐generation cephalosporins.32 The hospital had VRE rates similar to other NNIS System hospitals prior to beginning the program, but after antibiotic stewardship measures were implemented, the VRE rate began to drop, falling to 6% by 1999. This should be compared with a VRE rate of 24% for similar NNIS System hospitals in 1999.

As far as reducing healthcare costs, Figure 4A illustrates the direct antimicrobial cost savings at WFUBMC after implementation of the CAUSE antimicrobial stewardship program, and Figure 4B after supplemental interventions were implemented. Although decreasing antimicrobial cost is important, one would like to show decreases in overall healthcare costs associated with an antimicrobial stewardship program. Unfortunately, this is often a little more difficult to demonstrate. Extrapolations, however, may be possible. Because antimicrobial resistance, adverse drug effects, and secondary unintended infections such as C difficile colitis have been linked with increased patient morbidity and mortality, longer hospital stays, and increased healthcare costs,6, 89, 90 improved antimicrobial stewardship is expected to optimize patient care and lower overall healthcare costs. A study in a large tertiary care academic medical center estimated more than $4.25 million in total healthcare savings over 1 year with a stewardship program using both preauthorization and, to a lesser extent, prospective audit and feedback.91 Despite the fact cost saving should not be a primary goal of an antimicrobial stewardship program, lower antimicrobial costs can help keep a program funded and buttress a proposal for an antimicrobial stewardship program to hospital leadership.

Figure 4

Many hospitals recognize other areas where an antimicrobial stewardship program can demonstrate its value. This includes implementation of a rapid change in drug utilization during antimicrobial supply shortages and assistance with regulatory mandates and surgical infection prophylaxis. Stewardship teams often assist microbiology with protocols for microbiology reporting, antibiograms, planning for susceptibility testing, and communicating changes in microbiology tests or protocols to clinicians.

Conclusions

Overuse or misuse of antibiotics and other antimicrobials for hospital inpatients is relatively common, and can be associated with several unintended negative consequences. Improving medical care necessarily includes better use of antimicrobials to optimize outcomes and preserve the effectiveness of currently available agents. Further, an important additional consequence of effective antimicrobial stewardship and improved patient care is typically a lowering of overall healthcare costs. The recent 2007 IDSA/SHEA guidelines provide recommendations for developing an institutional program to enhance antimicrobial stewardship. However, individual institutions need to look closely at their own systems and patients to develop an antimicrobial stewardship program that best serves the needs of their hospital and the people it serves.

Collaboration between members of a multidisciplinary team is a key component of an effective institutional antimicrobial stewardship program, which itself is a key component of optimizing the care of hospitalized patients being treated with antimicrobial agents for proven or suspected infectious diseases. However, patient care does not and should not end once the patient is discharged from the hospital. In fact, high‐quality, value‐based health care across the full range of a medical condition depends on planning for optimization of care within the hospital as well as transitions of care to the outpatient setting. This extended care plan includes collaboration with multiple members of the health care community, both inside and outside the institution. The current review examines 3 aspects of patient care across the full cycle of an infectious disease condition: (1) value‐based health care, (2) stewardship of antimicrobials, and (3) community‐based parenteral anti‐infective therapy (CoPAT) as a model for antimicrobial stewardship outside the institutional setting.

Value‐Based Health Care

Patients first want to know that the health care professionals treating them actually care about them as individuals, and only then are patients concerned about how much the medical team knows. Patient‐centered care is a critical component of value‐based health care, a term that was bandied about quite a bit during the recent and ongoing health care debate in the United States. But what exactly does it mean? First, value in health care is defined by health care outcomes as a function of or divided by the cost of delivery of care. As Dr. Michael Porter and Dr. Elizabeth Olmsted Teisberg delineated in their 2007 article in the Journal of the American Medical Association,2 as well as in the 2006 book Redefining Health Care,3 The purpose of the healthcare system is not to minimize costs but to deliver value to patients, that is, better health per dollar spent. As they discuss value, it is a patient‐centric measure, and is focused on individual patient (not just diagnosis‐related group) outcomes and the cost of care across the full cycle. In this way of looking at things, an episode of care goes beyond the treatment provided during the acute admission to also include the transition of care to the outpatient or posthospital setting.

The reforms proposed by Porter and Teisberg are best achieved when the participating health care institutions have developed an information technology platform able to integrate and fully measure care across the full cycle of a medical condition. Furthermore, there is strong evidence that patient value increases with physician and team experience and volume for a particular condition.2 High volumes tend to correlate with the development of better information technology, as well as the formation of dedicated teams with tailored facilities, and with a greater capacity for constructive feedback to improve patient outcomes. The more experience a physician and team have with the management of a particular medical condition, the greater is the opportunity to learn and refine practices to provide greater value to the patient.

The Institute of Medicine has recommended that all healthcare professionals should be educated to deliver patient‐centered care as members of an interdisciplinary team emphasizing evidence‐based practice, quality improvement, and informatics.4 As has been demonstrated for patients with congestive heart failure59 and other conditions,10, 11 outcomes improve when components of care are integrated (often by nurse‐directed teams), preparing for the transition of care from the hospital to the home.12 This concept is the basis for the community‐based parenteral anti‐infective therapy program (CoPAT) at the Cleveland Clinic as a model for antimicrobial stewardship for patients requiring parenteral antimicrobial therapy at the time of discharge from the inpatient setting.

Community‐Based Parenteral Anti‐Infective Therapy as a Systems‐Based Approach to Antimicrobial Stewardship

A systems‐based approach for antimicrobial stewardship, CoPAT has been in operation at the Cleveland Clinic, a 1200‐bed hospital in downtown Cleveland, Ohio, since November 1979. The experiences of the authors and their colleagues demonstrate it to be a value‐based proposition for the patient that uses an antimicrobial stewardship platform. Also known as outpatient parenteral antimicrobial therapy (OPAT), CoPAT refers to the practice of administering antimicrobial therapy in the home or other outpatient settings, first introduced by Rucker and Harrison in 1974 in the context of outpatient management of cystic fibrosis.16 In the United States, CoPAT is a common practice today, and the IDSA has created practice guidelines for it.17

In 1983, Rehm and Weinstein coauthored an article describing their experiences at the Cleveland Clinic, in which selected patients were trained for home‐based antimicrobial therapy.12 Figure 1 illustrates the astronomical growth that has occurred over the years at the Cleveland Clinic in the number of patients discharged from the acute care center undergoing CoPAT (Gordon, unpublished data). It is anticipated that this growth will continue and in large part reflects the complexity of patients being seen and the desire to reduce length of stay. Evaluating the quality of any medical care is difficult, but there are 3 general approaches to assessing or measuring the quality of medical care: assessing the structure of care, assessing processes of care, and assessing outcomes.18 The quality of the CoPAT program at the Cleveland Clinic can be examined in the context of these 3 areas of assessment.

Figure 1

Settings or the Structure of Care

In a 1966 publication on quality of medical care evaluations, Donabedian described assessment of the structure of care as one of the primary approaches to measuring the quality of care.18 By structure, Donabedian meant the settings in which medical care takes place, including the adequacy of facilities and equipment, qualifications or expertise of medical staff and their organization, the administrative structure of the institution or institutional program of interest, and other administrative and related processes supporting and directing the delivery of care. Although the structure of care has the advantage of being concrete and relatively easy to assess, to be most meaningful, it ultimately needs to be related to the processes and outcomes of care.

With respect to the CoPAT program at the Cleveland Clinic main hospital, infectious diseases consultation is required for every patient being considered for discharge with parenteral antibiotics, whether the patient is going home or to another facility, including the clinic's own skilled nursing facility (SNF). Arrangements are then made for the delivery of antibiotics at home or in SNFs or long‐term acute care (LTAC) centers. The Cleveland Clinic CoPAT program does not use an outpatient infusion center.

The Cleveland Clinic uses a mandatory infectious diseases consultation for CoPAT because there are a number of important issues that need to be addressed before the patient is discharged, and for our system this is best accomplished by an infectious diseases specialist.12 For example, is antimicrobial therapy actually required in the first place? If it is, what is the optimal type, route, and duration of therapy? Are there other medical issues that need to be addressed? Decisions also need to be made about optimal vascular access and antimicrobial selection and administration, as well as arrangements being made for monitoring clinical and laboratory aspects. It is important that there is a smooth transition of care and prescheduled follow‐up in the outpatient clinic. The identification and use of an infectious diseases clinician directing the process leads to accountability. Notably, mandatory infectious disease consultation for outpatient parenteral antibiotic therapy has been used at Baystate Medical Center with improvement in reducing costs.19

The Process of Care

Assessments of the process of care involve examination of the particulars of medical care delivery, or whether what is recognized or accepted as good medical care has been applied. As discussed by Donabedian, process of care deals with issues such as the appropriateness and completeness of information obtained through clinical history, physical examination, and diagnostic tests; justification of diagnosis and therapy; technical competence in the performance of diagnostic and therapeutic procedures; and coordination and continuity of care.18

The CoPAT initiation process at the Cleveland Clinic is illustrated in Figure 2. It is a bundled process. As already mentioned, an infectious diseases consultation and evaluation is scheduled for all patients considered for CoPAT, after which a CoPAT form is completed and a follow‐up appointment made before the patient is discharged. In addition, the vascular access team is consulted and an appropriate vascular access device is placed in the patient prior to discharge. Likewise, a case manager is enlisted to identify a health care agency or SNF for patient placement or to determine whether the patient will receive home treatment. Once the appropriate setting is identified, the case manager transmits a completed CoPAT form to the health care agency or SNF, while forwarding a copy to the CoPAT nurse coordinator in the infectious disease department.

Figure 2

An electronic health record system is used at the Cleveland Clinic to provide real‐time information relevant for patient management. In 2007, a structured data form for CoPAT start‐of‐care was created within the Cleveland Clinic hospital electronic health record (EHR). This form contains a number of elements relevant for setting up patients for transition to CoPAT. In particular, the electronic CoPAT form contains information about the infection(s) and microorganism(s) being treated, intravenous antibiotic(s) prescribed (including treatment stop date), concurrent oral antibiotics, premedication recommendations (if appropriate), and recommended monitoring of laboratory tests. In addition, the form contains the telephone and fax numbers of the CoPAT coordinator and the name of the responsible physician, including a scheduled appointment for follow‐up (Fig. 3). The staff physician is responsible for completing the electronic CoPAT form or prescription. This CoPAT prescription then becomes part of the patient's electronic record and is transmissible and viewable by anyone with access to the EHR. This is important in terms of follow‐up and care accountability: an infectious disease staff clinician is identified as the contact person for clinical issues when a patient is on CoPAT.

Figure 3

After the patient is discharged, the CoPAT coordinator in the infectious disease department becomes responsible, together with the clinic's outpatient pharmacy, for reviewing laboratory results and notifying clinicians of potential problems that need to be addressed. These issues can pertain to laboratory findings, vascular access, or new symptoms or signs observed by the home nurse or patient. All this information is communicated via electronic health record messaging and/or through direct calls to the physician, when needed.

The CoPAT program has been widely accepted by internal customers of the Cleveland Clinic, which include hospitalists. This is probably because there is autonomy and accountability with the infectious diseases staff, the program or team is available 7 days per week, and the EHR facilitates communication. In addition, the use of infectious disease‐specific subspecialty groups (eg, bone marrow and solid‐organ transplant, bone and joint, and infective endocarditis groups) increases clinical credibility, as well as value received by patients of the clinic. Furthermore, the electronic CoPAT script facilitates discharge planning. CoPATs constitute approximately 25% of all ID consultation requests at the Cleveland Clinic and help to justify the 20 clinical ID clinical FTEs.

Outcomes of Medical Care

Assessment of medical care outcomes is another frequently used approach for measuring the quality of medical care.18 Medical care outcomes that have been examined as measures of quality of care include survival, number of hospital readmissions, time between discharge and readmissions, length of initial hospital stay and subsequent readmissions, quality of life, and health care costs. As has often been said, If you cannot measure it, you cannot manage it. The CoPAT program using the EHR has facilitated retrieval of structured reports in a format that provides clinicians with real‐time data enabling assessment of outcomes. By examining this data, the CoPAT team is in a better position to contemplate potential interventions for improving outpatient care and the value patients receive.

A 36‐month review of Cleveland Clinic CoPAT patient demographics from July 2007 to June 2010 demonstrated 6287 patients (56% male) had been prescribed 9471 courses of CoPAT (Gordon, unpublished data). Seventy‐nine percent of the patients were white, 16% African American, and 5% of other races. Most patients received 1 antibiotic per CoPAT course (79.1%), whereas 18.2%, 2.5%, and 0.2% received 2, 3, and 4 antibiotics per CoPAT course, respectively. Figure 4 highlights CoPAT distribution by source for anatomic site of infection. Bone and joint infections were the most common diagnoses associated with CoPAT at the Cleveland Clinic, followed by abdominal, cardiovascular, primary disseminated disease (eg, catheter‐associated bloodstream infections), and skin and soft‐tissue infection.

Figure 4

Figure 5 highlights the top‐10 pathogenic microorganisms in patients being discharged from the Cleveland Clinic with CoPAT, and the top‐10 antimicrobials prescribed for these patients. As can be seen, Staphylococcus aureus (methicillin susceptible and methicillin resistant) was the number one pathogen identified for patients undergoing CoPAT, followed by coagulase‐negative Staphylococcus and Enterococcus species. The most commonly identified gram‐negative bacteria among discharged patients was Pseudomonas aeruginosa. Only 2 of the top 10 pathogens were nonbacterial: Candida species and cytomegalovirus (CMV), the latter being the result of the high volume of transplantations performed at the clinic. With respect to the intravenous antimicrobials prescribed for patients undergoing CoPAT, the most commonly prescribed agent was vancomycin, followed by piperacillin/tazobactam. Of the 10 agents, only micafungin and ganciclovir were not antibacterial agents, indicating that the vast majority of patients discharged from the Cleveland Clinic with CoPAT had had bacterial, rather than fungal or viral, infections.

Figure 5

Of particular note, data collected from July 2007 through December 2008 demonstrated that more than 80% of patients discharged from the hospital with CoPAT did so with a prescheduled follow‐up visit. This patient‐centric measure is important because patients may not follow through with establishing appointments for follow‐up visits once discharge has already occurred. The Cleveland Clinic prides itself on making sure that a follow‐up appointment is actually made before the time of discharge for the vast majority of patients. The process also facilitates continuity of care with a specific infectious disease physician.

The various outcomes data collected by the Cleveland Clinic CoPAT Registry puts it in the position of being able to use the data to identify areas for improvement. Some of the projects made possible by the CoPAT Registry include analysis of: (1) outcomes of CoPAT in patients with bone and joint infections, (2) intensity of care in patients with cardiac and cardiac device infections while undergoing CoPAT, (3) C. difficile infections in patients undergoing CoPAT, and (4) emergency department (ED) visits or unanticipated readmissions in patients undergoing CoPAT. With respect to the last point, a 2009 article by Jencks and colleagues reported that 19.6% of the approximately 12 million Medicare beneficiaries who had been discharged from a hospital were rehospitalized within 30 days.20 Moreover, more than a third (34%) were rehospitalized within 90 days of discharge. It was estimated that no more than 10% of these readmissions were scheduled. More than 50% of patients with a medical condition who were rehospitalized within 30 days of discharge had not been billed for a physician visit between the time of discharge and hospitalization.20 This suggests that scheduling a follow‐up visit at the time of discharge might have reduced the need for many of these rehospitalizations. Unplanned rehospitalizations among the Medicare patients examined were not only relatively common but were also costly, resulting in an estimated $17.4 billion in additional Medicare costs.20 A New York Times editorial accompanying publication of the Jencks article noted that rehospitalizations and accompanying costs might be reduced by better discharge planning and closer cooperation between hospitals and physicians to ensure follow‐up care.21

At the Cleveland Clinic, data have recently been collected on the reasons for ED visits or hospital readmissions for patients receiving CoPAT at home through the Cleveland Clinic home care program. As illustrated in Figure 6, 24% of ED visits22 and 41% of hospital readmissions (Gordon, unpublished data) were for the infection being treated. Vascular access complications accounted for 23% of ED visits but only 2% of hospital readmissions. Nearly 50% of ED visits and 60% of hospital readmissions were for a reason unrelated to the infection being treated or CoPAT. It is hoped that closer examination of the data and perhaps additional analyses will suggest interventions to further reduce preventable readmissions or ED visits among patients discharged from the Cleveland Clinic on CoPAT.

Figure 6

Conclusions

Attention to antimicrobial stewardship and patient care should not end once the patient is discharged from the hospital or other institutional setting. Patients expect and should receive value‐based health care across the full cycle of their medical condition, and it is the responsibility of those caring for them to prepare for and provide such care during as well as after hospital discharge. The CoPAT program at the Cleveland Clinic provides a model for the extension of antimicrobial stewardship into the outpatient setting. The effectiveness of the program depends on a patient‐centric approach involving coordination and use of the expertise of multiple members of a team dedicated to patient value and facilitated by hospital‐based EHRs specialized for optimizing the transition of care into the outpatient setting for all patients scheduled to receive CoPAT. The quality of medical care provided by the Cleveland Clinic or other hospitals can be accessed through measurements of the structure, processes, and outcomes of care provided by the respective institutions. The data obtained can then be used to further refine care to optimize outcomes and provide high value for the patients treated at the institution. Achieving and then maintaining high‐quality medical care that provides value to patients is an ongoing process that should never be taken for granted.

Collaboration between members of a multidisciplinary team is a key component of an effective institutional antimicrobial stewardship program, which itself is a key component of optimizing the care of hospitalized patients being treated with antimicrobial agents for proven or suspected infectious diseases. However, patient care does not and should not end once the patient is discharged from the hospital. In fact, high‐quality, value‐based health care across the full range of a medical condition depends on planning for optimization of care within the hospital as well as transitions of care to the outpatient setting. This extended care plan includes collaboration with multiple members of the health care community, both inside and outside the institution. The current review examines 3 aspects of patient care across the full cycle of an infectious disease condition: (1) value‐based health care, (2) stewardship of antimicrobials, and (3) community‐based parenteral anti‐infective therapy (CoPAT) as a model for antimicrobial stewardship outside the institutional setting.

Value‐Based Health Care

Patients first want to know that the health care professionals treating them actually care about them as individuals, and only then are patients concerned about how much the medical team knows. Patient‐centered care is a critical component of value‐based health care, a term that was bandied about quite a bit during the recent and ongoing health care debate in the United States. But what exactly does it mean? First, value in health care is defined by health care outcomes as a function of or divided by the cost of delivery of care. As Dr. Michael Porter and Dr. Elizabeth Olmsted Teisberg delineated in their 2007 article in the Journal of the American Medical Association,2 as well as in the 2006 book Redefining Health Care,3 The purpose of the healthcare system is not to minimize costs but to deliver value to patients, that is, better health per dollar spent. As they discuss value, it is a patient‐centric measure, and is focused on individual patient (not just diagnosis‐related group) outcomes and the cost of care across the full cycle. In this way of looking at things, an episode of care goes beyond the treatment provided during the acute admission to also include the transition of care to the outpatient or posthospital setting.

The reforms proposed by Porter and Teisberg are best achieved when the participating health care institutions have developed an information technology platform able to integrate and fully measure care across the full cycle of a medical condition. Furthermore, there is strong evidence that patient value increases with physician and team experience and volume for a particular condition.2 High volumes tend to correlate with the development of better information technology, as well as the formation of dedicated teams with tailored facilities, and with a greater capacity for constructive feedback to improve patient outcomes. The more experience a physician and team have with the management of a particular medical condition, the greater is the opportunity to learn and refine practices to provide greater value to the patient.

The Institute of Medicine has recommended that all healthcare professionals should be educated to deliver patient‐centered care as members of an interdisciplinary team emphasizing evidence‐based practice, quality improvement, and informatics.4 As has been demonstrated for patients with congestive heart failure59 and other conditions,10, 11 outcomes improve when components of care are integrated (often by nurse‐directed teams), preparing for the transition of care from the hospital to the home.12 This concept is the basis for the community‐based parenteral anti‐infective therapy program (CoPAT) at the Cleveland Clinic as a model for antimicrobial stewardship for patients requiring parenteral antimicrobial therapy at the time of discharge from the inpatient setting.

Community‐Based Parenteral Anti‐Infective Therapy as a Systems‐Based Approach to Antimicrobial Stewardship

A systems‐based approach for antimicrobial stewardship, CoPAT has been in operation at the Cleveland Clinic, a 1200‐bed hospital in downtown Cleveland, Ohio, since November 1979. The experiences of the authors and their colleagues demonstrate it to be a value‐based proposition for the patient that uses an antimicrobial stewardship platform. Also known as outpatient parenteral antimicrobial therapy (OPAT), CoPAT refers to the practice of administering antimicrobial therapy in the home or other outpatient settings, first introduced by Rucker and Harrison in 1974 in the context of outpatient management of cystic fibrosis.16 In the United States, CoPAT is a common practice today, and the IDSA has created practice guidelines for it.17

In 1983, Rehm and Weinstein coauthored an article describing their experiences at the Cleveland Clinic, in which selected patients were trained for home‐based antimicrobial therapy.12 Figure 1 illustrates the astronomical growth that has occurred over the years at the Cleveland Clinic in the number of patients discharged from the acute care center undergoing CoPAT (Gordon, unpublished data). It is anticipated that this growth will continue and in large part reflects the complexity of patients being seen and the desire to reduce length of stay. Evaluating the quality of any medical care is difficult, but there are 3 general approaches to assessing or measuring the quality of medical care: assessing the structure of care, assessing processes of care, and assessing outcomes.18 The quality of the CoPAT program at the Cleveland Clinic can be examined in the context of these 3 areas of assessment.

Figure 1

Settings or the Structure of Care

In a 1966 publication on quality of medical care evaluations, Donabedian described assessment of the structure of care as one of the primary approaches to measuring the quality of care.18 By structure, Donabedian meant the settings in which medical care takes place, including the adequacy of facilities and equipment, qualifications or expertise of medical staff and their organization, the administrative structure of the institution or institutional program of interest, and other administrative and related processes supporting and directing the delivery of care. Although the structure of care has the advantage of being concrete and relatively easy to assess, to be most meaningful, it ultimately needs to be related to the processes and outcomes of care.

With respect to the CoPAT program at the Cleveland Clinic main hospital, infectious diseases consultation is required for every patient being considered for discharge with parenteral antibiotics, whether the patient is going home or to another facility, including the clinic's own skilled nursing facility (SNF). Arrangements are then made for the delivery of antibiotics at home or in SNFs or long‐term acute care (LTAC) centers. The Cleveland Clinic CoPAT program does not use an outpatient infusion center.

The Cleveland Clinic uses a mandatory infectious diseases consultation for CoPAT because there are a number of important issues that need to be addressed before the patient is discharged, and for our system this is best accomplished by an infectious diseases specialist.12 For example, is antimicrobial therapy actually required in the first place? If it is, what is the optimal type, route, and duration of therapy? Are there other medical issues that need to be addressed? Decisions also need to be made about optimal vascular access and antimicrobial selection and administration, as well as arrangements being made for monitoring clinical and laboratory aspects. It is important that there is a smooth transition of care and prescheduled follow‐up in the outpatient clinic. The identification and use of an infectious diseases clinician directing the process leads to accountability. Notably, mandatory infectious disease consultation for outpatient parenteral antibiotic therapy has been used at Baystate Medical Center with improvement in reducing costs.19

The Process of Care

Assessments of the process of care involve examination of the particulars of medical care delivery, or whether what is recognized or accepted as good medical care has been applied. As discussed by Donabedian, process of care deals with issues such as the appropriateness and completeness of information obtained through clinical history, physical examination, and diagnostic tests; justification of diagnosis and therapy; technical competence in the performance of diagnostic and therapeutic procedures; and coordination and continuity of care.18

The CoPAT initiation process at the Cleveland Clinic is illustrated in Figure 2. It is a bundled process. As already mentioned, an infectious diseases consultation and evaluation is scheduled for all patients considered for CoPAT, after which a CoPAT form is completed and a follow‐up appointment made before the patient is discharged. In addition, the vascular access team is consulted and an appropriate vascular access device is placed in the patient prior to discharge. Likewise, a case manager is enlisted to identify a health care agency or SNF for patient placement or to determine whether the patient will receive home treatment. Once the appropriate setting is identified, the case manager transmits a completed CoPAT form to the health care agency or SNF, while forwarding a copy to the CoPAT nurse coordinator in the infectious disease department.

Figure 2

An electronic health record system is used at the Cleveland Clinic to provide real‐time information relevant for patient management. In 2007, a structured data form for CoPAT start‐of‐care was created within the Cleveland Clinic hospital electronic health record (EHR). This form contains a number of elements relevant for setting up patients for transition to CoPAT. In particular, the electronic CoPAT form contains information about the infection(s) and microorganism(s) being treated, intravenous antibiotic(s) prescribed (including treatment stop date), concurrent oral antibiotics, premedication recommendations (if appropriate), and recommended monitoring of laboratory tests. In addition, the form contains the telephone and fax numbers of the CoPAT coordinator and the name of the responsible physician, including a scheduled appointment for follow‐up (Fig. 3). The staff physician is responsible for completing the electronic CoPAT form or prescription. This CoPAT prescription then becomes part of the patient's electronic record and is transmissible and viewable by anyone with access to the EHR. This is important in terms of follow‐up and care accountability: an infectious disease staff clinician is identified as the contact person for clinical issues when a patient is on CoPAT.

Figure 3

After the patient is discharged, the CoPAT coordinator in the infectious disease department becomes responsible, together with the clinic's outpatient pharmacy, for reviewing laboratory results and notifying clinicians of potential problems that need to be addressed. These issues can pertain to laboratory findings, vascular access, or new symptoms or signs observed by the home nurse or patient. All this information is communicated via electronic health record messaging and/or through direct calls to the physician, when needed.

The CoPAT program has been widely accepted by internal customers of the Cleveland Clinic, which include hospitalists. This is probably because there is autonomy and accountability with the infectious diseases staff, the program or team is available 7 days per week, and the EHR facilitates communication. In addition, the use of infectious disease‐specific subspecialty groups (eg, bone marrow and solid‐organ transplant, bone and joint, and infective endocarditis groups) increases clinical credibility, as well as value received by patients of the clinic. Furthermore, the electronic CoPAT script facilitates discharge planning. CoPATs constitute approximately 25% of all ID consultation requests at the Cleveland Clinic and help to justify the 20 clinical ID clinical FTEs.

Outcomes of Medical Care

Assessment of medical care outcomes is another frequently used approach for measuring the quality of medical care.18 Medical care outcomes that have been examined as measures of quality of care include survival, number of hospital readmissions, time between discharge and readmissions, length of initial hospital stay and subsequent readmissions, quality of life, and health care costs. As has often been said, If you cannot measure it, you cannot manage it. The CoPAT program using the EHR has facilitated retrieval of structured reports in a format that provides clinicians with real‐time data enabling assessment of outcomes. By examining this data, the CoPAT team is in a better position to contemplate potential interventions for improving outpatient care and the value patients receive.

A 36‐month review of Cleveland Clinic CoPAT patient demographics from July 2007 to June 2010 demonstrated 6287 patients (56% male) had been prescribed 9471 courses of CoPAT (Gordon, unpublished data). Seventy‐nine percent of the patients were white, 16% African American, and 5% of other races. Most patients received 1 antibiotic per CoPAT course (79.1%), whereas 18.2%, 2.5%, and 0.2% received 2, 3, and 4 antibiotics per CoPAT course, respectively. Figure 4 highlights CoPAT distribution by source for anatomic site of infection. Bone and joint infections were the most common diagnoses associated with CoPAT at the Cleveland Clinic, followed by abdominal, cardiovascular, primary disseminated disease (eg, catheter‐associated bloodstream infections), and skin and soft‐tissue infection.

Figure 4

Figure 5 highlights the top‐10 pathogenic microorganisms in patients being discharged from the Cleveland Clinic with CoPAT, and the top‐10 antimicrobials prescribed for these patients. As can be seen, Staphylococcus aureus (methicillin susceptible and methicillin resistant) was the number one pathogen identified for patients undergoing CoPAT, followed by coagulase‐negative Staphylococcus and Enterococcus species. The most commonly identified gram‐negative bacteria among discharged patients was Pseudomonas aeruginosa. Only 2 of the top 10 pathogens were nonbacterial: Candida species and cytomegalovirus (CMV), the latter being the result of the high volume of transplantations performed at the clinic. With respect to the intravenous antimicrobials prescribed for patients undergoing CoPAT, the most commonly prescribed agent was vancomycin, followed by piperacillin/tazobactam. Of the 10 agents, only micafungin and ganciclovir were not antibacterial agents, indicating that the vast majority of patients discharged from the Cleveland Clinic with CoPAT had had bacterial, rather than fungal or viral, infections.

Figure 5

Of particular note, data collected from July 2007 through December 2008 demonstrated that more than 80% of patients discharged from the hospital with CoPAT did so with a prescheduled follow‐up visit. This patient‐centric measure is important because patients may not follow through with establishing appointments for follow‐up visits once discharge has already occurred. The Cleveland Clinic prides itself on making sure that a follow‐up appointment is actually made before the time of discharge for the vast majority of patients. The process also facilitates continuity of care with a specific infectious disease physician.

The various outcomes data collected by the Cleveland Clinic CoPAT Registry puts it in the position of being able to use the data to identify areas for improvement. Some of the projects made possible by the CoPAT Registry include analysis of: (1) outcomes of CoPAT in patients with bone and joint infections, (2) intensity of care in patients with cardiac and cardiac device infections while undergoing CoPAT, (3) C. difficile infections in patients undergoing CoPAT, and (4) emergency department (ED) visits or unanticipated readmissions in patients undergoing CoPAT. With respect to the last point, a 2009 article by Jencks and colleagues reported that 19.6% of the approximately 12 million Medicare beneficiaries who had been discharged from a hospital were rehospitalized within 30 days.20 Moreover, more than a third (34%) were rehospitalized within 90 days of discharge. It was estimated that no more than 10% of these readmissions were scheduled. More than 50% of patients with a medical condition who were rehospitalized within 30 days of discharge had not been billed for a physician visit between the time of discharge and hospitalization.20 This suggests that scheduling a follow‐up visit at the time of discharge might have reduced the need for many of these rehospitalizations. Unplanned rehospitalizations among the Medicare patients examined were not only relatively common but were also costly, resulting in an estimated $17.4 billion in additional Medicare costs.20 A New York Times editorial accompanying publication of the Jencks article noted that rehospitalizations and accompanying costs might be reduced by better discharge planning and closer cooperation between hospitals and physicians to ensure follow‐up care.21

At the Cleveland Clinic, data have recently been collected on the reasons for ED visits or hospital readmissions for patients receiving CoPAT at home through the Cleveland Clinic home care program. As illustrated in Figure 6, 24% of ED visits22 and 41% of hospital readmissions (Gordon, unpublished data) were for the infection being treated. Vascular access complications accounted for 23% of ED visits but only 2% of hospital readmissions. Nearly 50% of ED visits and 60% of hospital readmissions were for a reason unrelated to the infection being treated or CoPAT. It is hoped that closer examination of the data and perhaps additional analyses will suggest interventions to further reduce preventable readmissions or ED visits among patients discharged from the Cleveland Clinic on CoPAT.

Figure 6

Conclusions

Attention to antimicrobial stewardship and patient care should not end once the patient is discharged from the hospital or other institutional setting. Patients expect and should receive value‐based health care across the full cycle of their medical condition, and it is the responsibility of those caring for them to prepare for and provide such care during as well as after hospital discharge. The CoPAT program at the Cleveland Clinic provides a model for the extension of antimicrobial stewardship into the outpatient setting. The effectiveness of the program depends on a patient‐centric approach involving coordination and use of the expertise of multiple members of a team dedicated to patient value and facilitated by hospital‐based EHRs specialized for optimizing the transition of care into the outpatient setting for all patients scheduled to receive CoPAT. The quality of medical care provided by the Cleveland Clinic or other hospitals can be accessed through measurements of the structure, processes, and outcomes of care provided by the respective institutions. The data obtained can then be used to further refine care to optimize outcomes and provide high value for the patients treated at the institution. Achieving and then maintaining high‐quality medical care that provides value to patients is an ongoing process that should never be taken for granted.

Collaboration between members of a multidisciplinary team is a key component of an effective institutional antimicrobial stewardship program, which itself is a key component of optimizing the care of hospitalized patients being treated with antimicrobial agents for proven or suspected infectious diseases. However, patient care does not and should not end once the patient is discharged from the hospital. In fact, high‐quality, value‐based health care across the full range of a medical condition depends on planning for optimization of care within the hospital as well as transitions of care to the outpatient setting. This extended care plan includes collaboration with multiple members of the health care community, both inside and outside the institution. The current review examines 3 aspects of patient care across the full cycle of an infectious disease condition: (1) value‐based health care, (2) stewardship of antimicrobials, and (3) community‐based parenteral anti‐infective therapy (CoPAT) as a model for antimicrobial stewardship outside the institutional setting.

Value‐Based Health Care

Patients first want to know that the health care professionals treating them actually care about them as individuals, and only then are patients concerned about how much the medical team knows. Patient‐centered care is a critical component of value‐based health care, a term that was bandied about quite a bit during the recent and ongoing health care debate in the United States. But what exactly does it mean? First, value in health care is defined by health care outcomes as a function of or divided by the cost of delivery of care. As Dr. Michael Porter and Dr. Elizabeth Olmsted Teisberg delineated in their 2007 article in the Journal of the American Medical Association,2 as well as in the 2006 book Redefining Health Care,3 The purpose of the healthcare system is not to minimize costs but to deliver value to patients, that is, better health per dollar spent. As they discuss value, it is a patient‐centric measure, and is focused on individual patient (not just diagnosis‐related group) outcomes and the cost of care across the full cycle. In this way of looking at things, an episode of care goes beyond the treatment provided during the acute admission to also include the transition of care to the outpatient or posthospital setting.

The reforms proposed by Porter and Teisberg are best achieved when the participating health care institutions have developed an information technology platform able to integrate and fully measure care across the full cycle of a medical condition. Furthermore, there is strong evidence that patient value increases with physician and team experience and volume for a particular condition.2 High volumes tend to correlate with the development of better information technology, as well as the formation of dedicated teams with tailored facilities, and with a greater capacity for constructive feedback to improve patient outcomes. The more experience a physician and team have with the management of a particular medical condition, the greater is the opportunity to learn and refine practices to provide greater value to the patient.

The Institute of Medicine has recommended that all healthcare professionals should be educated to deliver patient‐centered care as members of an interdisciplinary team emphasizing evidence‐based practice, quality improvement, and informatics.4 As has been demonstrated for patients with congestive heart failure59 and other conditions,10, 11 outcomes improve when components of care are integrated (often by nurse‐directed teams), preparing for the transition of care from the hospital to the home.12 This concept is the basis for the community‐based parenteral anti‐infective therapy program (CoPAT) at the Cleveland Clinic as a model for antimicrobial stewardship for patients requiring parenteral antimicrobial therapy at the time of discharge from the inpatient setting.

Community‐Based Parenteral Anti‐Infective Therapy as a Systems‐Based Approach to Antimicrobial Stewardship

A systems‐based approach for antimicrobial stewardship, CoPAT has been in operation at the Cleveland Clinic, a 1200‐bed hospital in downtown Cleveland, Ohio, since November 1979. The experiences of the authors and their colleagues demonstrate it to be a value‐based proposition for the patient that uses an antimicrobial stewardship platform. Also known as outpatient parenteral antimicrobial therapy (OPAT), CoPAT refers to the practice of administering antimicrobial therapy in the home or other outpatient settings, first introduced by Rucker and Harrison in 1974 in the context of outpatient management of cystic fibrosis.16 In the United States, CoPAT is a common practice today, and the IDSA has created practice guidelines for it.17

In 1983, Rehm and Weinstein coauthored an article describing their experiences at the Cleveland Clinic, in which selected patients were trained for home‐based antimicrobial therapy.12 Figure 1 illustrates the astronomical growth that has occurred over the years at the Cleveland Clinic in the number of patients discharged from the acute care center undergoing CoPAT (Gordon, unpublished data). It is anticipated that this growth will continue and in large part reflects the complexity of patients being seen and the desire to reduce length of stay. Evaluating the quality of any medical care is difficult, but there are 3 general approaches to assessing or measuring the quality of medical care: assessing the structure of care, assessing processes of care, and assessing outcomes.18 The quality of the CoPAT program at the Cleveland Clinic can be examined in the context of these 3 areas of assessment.

Figure 1

Settings or the Structure of Care

In a 1966 publication on quality of medical care evaluations, Donabedian described assessment of the structure of care as one of the primary approaches to measuring the quality of care.18 By structure, Donabedian meant the settings in which medical care takes place, including the adequacy of facilities and equipment, qualifications or expertise of medical staff and their organization, the administrative structure of the institution or institutional program of interest, and other administrative and related processes supporting and directing the delivery of care. Although the structure of care has the advantage of being concrete and relatively easy to assess, to be most meaningful, it ultimately needs to be related to the processes and outcomes of care.

With respect to the CoPAT program at the Cleveland Clinic main hospital, infectious diseases consultation is required for every patient being considered for discharge with parenteral antibiotics, whether the patient is going home or to another facility, including the clinic's own skilled nursing facility (SNF). Arrangements are then made for the delivery of antibiotics at home or in SNFs or long‐term acute care (LTAC) centers. The Cleveland Clinic CoPAT program does not use an outpatient infusion center.

The Cleveland Clinic uses a mandatory infectious diseases consultation for CoPAT because there are a number of important issues that need to be addressed before the patient is discharged, and for our system this is best accomplished by an infectious diseases specialist.12 For example, is antimicrobial therapy actually required in the first place? If it is, what is the optimal type, route, and duration of therapy? Are there other medical issues that need to be addressed? Decisions also need to be made about optimal vascular access and antimicrobial selection and administration, as well as arrangements being made for monitoring clinical and laboratory aspects. It is important that there is a smooth transition of care and prescheduled follow‐up in the outpatient clinic. The identification and use of an infectious diseases clinician directing the process leads to accountability. Notably, mandatory infectious disease consultation for outpatient parenteral antibiotic therapy has been used at Baystate Medical Center with improvement in reducing costs.19

The Process of Care

Assessments of the process of care involve examination of the particulars of medical care delivery, or whether what is recognized or accepted as good medical care has been applied. As discussed by Donabedian, process of care deals with issues such as the appropriateness and completeness of information obtained through clinical history, physical examination, and diagnostic tests; justification of diagnosis and therapy; technical competence in the performance of diagnostic and therapeutic procedures; and coordination and continuity of care.18

The CoPAT initiation process at the Cleveland Clinic is illustrated in Figure 2. It is a bundled process. As already mentioned, an infectious diseases consultation and evaluation is scheduled for all patients considered for CoPAT, after which a CoPAT form is completed and a follow‐up appointment made before the patient is discharged. In addition, the vascular access team is consulted and an appropriate vascular access device is placed in the patient prior to discharge. Likewise, a case manager is enlisted to identify a health care agency or SNF for patient placement or to determine whether the patient will receive home treatment. Once the appropriate setting is identified, the case manager transmits a completed CoPAT form to the health care agency or SNF, while forwarding a copy to the CoPAT nurse coordinator in the infectious disease department.

Figure 2

An electronic health record system is used at the Cleveland Clinic to provide real‐time information relevant for patient management. In 2007, a structured data form for CoPAT start‐of‐care was created within the Cleveland Clinic hospital electronic health record (EHR). This form contains a number of elements relevant for setting up patients for transition to CoPAT. In particular, the electronic CoPAT form contains information about the infection(s) and microorganism(s) being treated, intravenous antibiotic(s) prescribed (including treatment stop date), concurrent oral antibiotics, premedication recommendations (if appropriate), and recommended monitoring of laboratory tests. In addition, the form contains the telephone and fax numbers of the CoPAT coordinator and the name of the responsible physician, including a scheduled appointment for follow‐up (Fig. 3). The staff physician is responsible for completing the electronic CoPAT form or prescription. This CoPAT prescription then becomes part of the patient's electronic record and is transmissible and viewable by anyone with access to the EHR. This is important in terms of follow‐up and care accountability: an infectious disease staff clinician is identified as the contact person for clinical issues when a patient is on CoPAT.

Figure 3

After the patient is discharged, the CoPAT coordinator in the infectious disease department becomes responsible, together with the clinic's outpatient pharmacy, for reviewing laboratory results and notifying clinicians of potential problems that need to be addressed. These issues can pertain to laboratory findings, vascular access, or new symptoms or signs observed by the home nurse or patient. All this information is communicated via electronic health record messaging and/or through direct calls to the physician, when needed.

The CoPAT program has been widely accepted by internal customers of the Cleveland Clinic, which include hospitalists. This is probably because there is autonomy and accountability with the infectious diseases staff, the program or team is available 7 days per week, and the EHR facilitates communication. In addition, the use of infectious disease‐specific subspecialty groups (eg, bone marrow and solid‐organ transplant, bone and joint, and infective endocarditis groups) increases clinical credibility, as well as value received by patients of the clinic. Furthermore, the electronic CoPAT script facilitates discharge planning. CoPATs constitute approximately 25% of all ID consultation requests at the Cleveland Clinic and help to justify the 20 clinical ID clinical FTEs.

Outcomes of Medical Care

Assessment of medical care outcomes is another frequently used approach for measuring the quality of medical care.18 Medical care outcomes that have been examined as measures of quality of care include survival, number of hospital readmissions, time between discharge and readmissions, length of initial hospital stay and subsequent readmissions, quality of life, and health care costs. As has often been said, If you cannot measure it, you cannot manage it. The CoPAT program using the EHR has facilitated retrieval of structured reports in a format that provides clinicians with real‐time data enabling assessment of outcomes. By examining this data, the CoPAT team is in a better position to contemplate potential interventions for improving outpatient care and the value patients receive.

A 36‐month review of Cleveland Clinic CoPAT patient demographics from July 2007 to June 2010 demonstrated 6287 patients (56% male) had been prescribed 9471 courses of CoPAT (Gordon, unpublished data). Seventy‐nine percent of the patients were white, 16% African American, and 5% of other races. Most patients received 1 antibiotic per CoPAT course (79.1%), whereas 18.2%, 2.5%, and 0.2% received 2, 3, and 4 antibiotics per CoPAT course, respectively. Figure 4 highlights CoPAT distribution by source for anatomic site of infection. Bone and joint infections were the most common diagnoses associated with CoPAT at the Cleveland Clinic, followed by abdominal, cardiovascular, primary disseminated disease (eg, catheter‐associated bloodstream infections), and skin and soft‐tissue infection.

Figure 4

Figure 5 highlights the top‐10 pathogenic microorganisms in patients being discharged from the Cleveland Clinic with CoPAT, and the top‐10 antimicrobials prescribed for these patients. As can be seen, Staphylococcus aureus (methicillin susceptible and methicillin resistant) was the number one pathogen identified for patients undergoing CoPAT, followed by coagulase‐negative Staphylococcus and Enterococcus species. The most commonly identified gram‐negative bacteria among discharged patients was Pseudomonas aeruginosa. Only 2 of the top 10 pathogens were nonbacterial: Candida species and cytomegalovirus (CMV), the latter being the result of the high volume of transplantations performed at the clinic. With respect to the intravenous antimicrobials prescribed for patients undergoing CoPAT, the most commonly prescribed agent was vancomycin, followed by piperacillin/tazobactam. Of the 10 agents, only micafungin and ganciclovir were not antibacterial agents, indicating that the vast majority of patients discharged from the Cleveland Clinic with CoPAT had had bacterial, rather than fungal or viral, infections.

Figure 5

Of particular note, data collected from July 2007 through December 2008 demonstrated that more than 80% of patients discharged from the hospital with CoPAT did so with a prescheduled follow‐up visit. This patient‐centric measure is important because patients may not follow through with establishing appointments for follow‐up visits once discharge has already occurred. The Cleveland Clinic prides itself on making sure that a follow‐up appointment is actually made before the time of discharge for the vast majority of patients. The process also facilitates continuity of care with a specific infectious disease physician.

The various outcomes data collected by the Cleveland Clinic CoPAT Registry puts it in the position of being able to use the data to identify areas for improvement. Some of the projects made possible by the CoPAT Registry include analysis of: (1) outcomes of CoPAT in patients with bone and joint infections, (2) intensity of care in patients with cardiac and cardiac device infections while undergoing CoPAT, (3) C. difficile infections in patients undergoing CoPAT, and (4) emergency department (ED) visits or unanticipated readmissions in patients undergoing CoPAT. With respect to the last point, a 2009 article by Jencks and colleagues reported that 19.6% of the approximately 12 million Medicare beneficiaries who had been discharged from a hospital were rehospitalized within 30 days.20 Moreover, more than a third (34%) were rehospitalized within 90 days of discharge. It was estimated that no more than 10% of these readmissions were scheduled. More than 50% of patients with a medical condition who were rehospitalized within 30 days of discharge had not been billed for a physician visit between the time of discharge and hospitalization.20 This suggests that scheduling a follow‐up visit at the time of discharge might have reduced the need for many of these rehospitalizations. Unplanned rehospitalizations among the Medicare patients examined were not only relatively common but were also costly, resulting in an estimated $17.4 billion in additional Medicare costs.20 A New York Times editorial accompanying publication of the Jencks article noted that rehospitalizations and accompanying costs might be reduced by better discharge planning and closer cooperation between hospitals and physicians to ensure follow‐up care.21

At the Cleveland Clinic, data have recently been collected on the reasons for ED visits or hospital readmissions for patients receiving CoPAT at home through the Cleveland Clinic home care program. As illustrated in Figure 6, 24% of ED visits22 and 41% of hospital readmissions (Gordon, unpublished data) were for the infection being treated. Vascular access complications accounted for 23% of ED visits but only 2% of hospital readmissions. Nearly 50% of ED visits and 60% of hospital readmissions were for a reason unrelated to the infection being treated or CoPAT. It is hoped that closer examination of the data and perhaps additional analyses will suggest interventions to further reduce preventable readmissions or ED visits among patients discharged from the Cleveland Clinic on CoPAT.

Figure 6

Conclusions

Attention to antimicrobial stewardship and patient care should not end once the patient is discharged from the hospital or other institutional setting. Patients expect and should receive value‐based health care across the full cycle of their medical condition, and it is the responsibility of those caring for them to prepare for and provide such care during as well as after hospital discharge. The CoPAT program at the Cleveland Clinic provides a model for the extension of antimicrobial stewardship into the outpatient setting. The effectiveness of the program depends on a patient‐centric approach involving coordination and use of the expertise of multiple members of a team dedicated to patient value and facilitated by hospital‐based EHRs specialized for optimizing the transition of care into the outpatient setting for all patients scheduled to receive CoPAT. The quality of medical care provided by the Cleveland Clinic or other hospitals can be accessed through measurements of the structure, processes, and outcomes of care provided by the respective institutions. The data obtained can then be used to further refine care to optimize outcomes and provide high value for the patients treated at the institution. Achieving and then maintaining high‐quality medical care that provides value to patients is an ongoing process that should never be taken for granted.

RELEASE DATE: January 15, 2011 EXPIRATION DATE: January 31, 2012

Estimated time to complete the activity: 1 hour 45 minutes

Jointly sponsored by Postgraduate Institute for Medicine and Global Education Exchange, Inc

This activity is supported by an educational grant from Merck & Co., Inc.

Program Description

With antimicrobial resistance on the rise and very few new pharmaceutical agents in development, a well‐managed antimicrobial stewardship program in the hospital becomes the first‐line defense against the emergence of resistance and provides not only a cost‐containment measure but also ensures the continued efficacy of available antimicrobials. A successful stewardship program knows and understands the local epidemiology and utilizes a multidisciplinary strategy to ensure the selection of an appropriate antibiotic at the right dose for the right duration. In addition, stewardship in the community‐based parenteral antiinfective therapy (CoPAT) program provides an opportunity for an integrated patient‐centric model of care as well as continunity of care when patients transition from inpatient to outpatient setting.

Learning Objectives

• Explain the impact of multidisciplinary antimicrobial stewardship programs on the emergence and transmission of antimicrobial‐resistant microorganisms

• Identify potential challenges and controversies related to the implementation of antimicrobial stewardship programs in health systems

• Use pharmacokinetic and pharmacodynamic data to facilitate appropriate antimicrobial use

• Describe the role of CoPAT in an integrated patient‐centric model of antimicrobial stewardship and pharmaco epidemiology

• Illustrate how a CoPAT model of care can be used to mitigate complications and prevent emergency room visits and readmissions

Target Audience

This activity has been designed to meet the educational needs of hospitalists and other healthcare providers involved in the treatment of patients with infectious diseases.

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Global Education Exchange, Inc. (GLOBEX). PIM is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

Postgraduate Institute for Medicine designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty

James Pile, MD [Chairman] Director, Division of Hospital Medicine Case Western Reserve University at MetroHealth Medical Center Cleveland, Ohio Steven M. Gordon, MD Chairman, Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Nabin Shrestha, MD Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Susan J. Rehm, MD Vice Chair, Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Thomas Lodise, PharmD Associate Professor, Albany College of Pharmacy Albany, New York Jill Butterfield, PharmD Albany College of Pharmacy Albany, New York Arjun Srinivasan, MD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia Christopher A. Ohl, MD Associate Professor Internal Medicine‐Infectious Diseases Wake Forest University, Baptist Medical Center, Winston‐Salem, North Carolina Vera P. Luther, MD, Assistant Professor of Medicine Section of Infectious Diseases and Department of Internal Medicine Wake Forest University School of Medicine Winston‐Salem, North Carolina

Disclosure of Conflicts of Interest

The Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:0

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:0, 0

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Postgraduate Institute for Medicine (PIM), Global Education Exchange, Inc. (GLOBEX) and Merck & Co., Inc. do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of PIM, GLOBEX and Merck & Co., Inc. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Method of Participation:

There are no fees for participating and receiving CME credit for this activity. During the period January 15, 2011 through January 31, 2012, participants must read the learning objectives and faculty disclosures and study the educational activity.

PIM supports Green CME by offering your Request for Credit online. If you wish to receive acknowledgment for completing this activity, please complete the post‐test and evaluation on www.cmeuniversity.com. On the navigation menu, click on Find Post‐test/Evaluation by Course and search by course ID 6903. Upon registering and successfully completing the post‐test with a score of 70% or better and the activity evaluation, your certificate will be made available immediately. Processing credit requests online will reduce the amount of paper used by nearly 100,000 sheets per year.

Media:

Journal supplement

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

RELEASE DATE: January 15, 2011 EXPIRATION DATE: January 31, 2012

Estimated time to complete the activity: 1 hour 45 minutes

Jointly sponsored by Postgraduate Institute for Medicine and Global Education Exchange, Inc

This activity is supported by an educational grant from Merck & Co., Inc.

Program Description

With antimicrobial resistance on the rise and very few new pharmaceutical agents in development, a well‐managed antimicrobial stewardship program in the hospital becomes the first‐line defense against the emergence of resistance and provides not only a cost‐containment measure but also ensures the continued efficacy of available antimicrobials. A successful stewardship program knows and understands the local epidemiology and utilizes a multidisciplinary strategy to ensure the selection of an appropriate antibiotic at the right dose for the right duration. In addition, stewardship in the community‐based parenteral antiinfective therapy (CoPAT) program provides an opportunity for an integrated patient‐centric model of care as well as continunity of care when patients transition from inpatient to outpatient setting.

Learning Objectives

• Explain the impact of multidisciplinary antimicrobial stewardship programs on the emergence and transmission of antimicrobial‐resistant microorganisms

• Identify potential challenges and controversies related to the implementation of antimicrobial stewardship programs in health systems

• Use pharmacokinetic and pharmacodynamic data to facilitate appropriate antimicrobial use

• Describe the role of CoPAT in an integrated patient‐centric model of antimicrobial stewardship and pharmaco epidemiology

• Illustrate how a CoPAT model of care can be used to mitigate complications and prevent emergency room visits and readmissions

Target Audience

This activity has been designed to meet the educational needs of hospitalists and other healthcare providers involved in the treatment of patients with infectious diseases.

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Global Education Exchange, Inc. (GLOBEX). PIM is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

Postgraduate Institute for Medicine designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty

James Pile, MD [Chairman] Director, Division of Hospital Medicine Case Western Reserve University at MetroHealth Medical Center Cleveland, Ohio Steven M. Gordon, MD Chairman, Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Nabin Shrestha, MD Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Susan J. Rehm, MD Vice Chair, Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Thomas Lodise, PharmD Associate Professor, Albany College of Pharmacy Albany, New York Jill Butterfield, PharmD Albany College of Pharmacy Albany, New York Arjun Srinivasan, MD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia Christopher A. Ohl, MD Associate Professor Internal Medicine‐Infectious Diseases Wake Forest University, Baptist Medical Center, Winston‐Salem, North Carolina Vera P. Luther, MD, Assistant Professor of Medicine Section of Infectious Diseases and Department of Internal Medicine Wake Forest University School of Medicine Winston‐Salem, North Carolina

Disclosure of Conflicts of Interest

The Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:0

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:0, 0

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Postgraduate Institute for Medicine (PIM), Global Education Exchange, Inc. (GLOBEX) and Merck & Co., Inc. do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of PIM, GLOBEX and Merck & Co., Inc. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Method of Participation:

There are no fees for participating and receiving CME credit for this activity. During the period January 15, 2011 through January 31, 2012, participants must read the learning objectives and faculty disclosures and study the educational activity.

PIM supports Green CME by offering your Request for Credit online. If you wish to receive acknowledgment for completing this activity, please complete the post‐test and evaluation on www.cmeuniversity.com. On the navigation menu, click on Find Post‐test/Evaluation by Course and search by course ID 6903. Upon registering and successfully completing the post‐test with a score of 70% or better and the activity evaluation, your certificate will be made available immediately. Processing credit requests online will reduce the amount of paper used by nearly 100,000 sheets per year.

Media:

Journal supplement

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

RELEASE DATE: January 15, 2011 EXPIRATION DATE: January 31, 2012

Estimated time to complete the activity: 1 hour 45 minutes

Jointly sponsored by Postgraduate Institute for Medicine and Global Education Exchange, Inc

This activity is supported by an educational grant from Merck & Co., Inc.

Program Description

With antimicrobial resistance on the rise and very few new pharmaceutical agents in development, a well‐managed antimicrobial stewardship program in the hospital becomes the first‐line defense against the emergence of resistance and provides not only a cost‐containment measure but also ensures the continued efficacy of available antimicrobials. A successful stewardship program knows and understands the local epidemiology and utilizes a multidisciplinary strategy to ensure the selection of an appropriate antibiotic at the right dose for the right duration. In addition, stewardship in the community‐based parenteral antiinfective therapy (CoPAT) program provides an opportunity for an integrated patient‐centric model of care as well as continunity of care when patients transition from inpatient to outpatient setting.

Learning Objectives

• Explain the impact of multidisciplinary antimicrobial stewardship programs on the emergence and transmission of antimicrobial‐resistant microorganisms

• Identify potential challenges and controversies related to the implementation of antimicrobial stewardship programs in health systems

• Use pharmacokinetic and pharmacodynamic data to facilitate appropriate antimicrobial use

• Describe the role of CoPAT in an integrated patient‐centric model of antimicrobial stewardship and pharmaco epidemiology

• Illustrate how a CoPAT model of care can be used to mitigate complications and prevent emergency room visits and readmissions

Target Audience

This activity has been designed to meet the educational needs of hospitalists and other healthcare providers involved in the treatment of patients with infectious diseases.

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Global Education Exchange, Inc. (GLOBEX). PIM is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

Postgraduate Institute for Medicine designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty

James Pile, MD [Chairman] Director, Division of Hospital Medicine Case Western Reserve University at MetroHealth Medical Center Cleveland, Ohio Steven M. Gordon, MD Chairman, Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Nabin Shrestha, MD Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Susan J. Rehm, MD Vice Chair, Department of Infectious Disease Cleveland Clinic, Cleveland, Ohio Thomas Lodise, PharmD Associate Professor, Albany College of Pharmacy Albany, New York Jill Butterfield, PharmD Albany College of Pharmacy Albany, New York Arjun Srinivasan, MD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia Christopher A. Ohl, MD Associate Professor Internal Medicine‐Infectious Diseases Wake Forest University, Baptist Medical Center, Winston‐Salem, North Carolina Vera P. Luther, MD, Assistant Professor of Medicine Section of Infectious Diseases and Department of Internal Medicine Wake Forest University School of Medicine Winston‐Salem, North Carolina

Disclosure of Conflicts of Interest

The Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:0

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:0, 0

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Postgraduate Institute for Medicine (PIM), Global Education Exchange, Inc. (GLOBEX) and Merck & Co., Inc. do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of PIM, GLOBEX and Merck & Co., Inc. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Method of Participation:

There are no fees for participating and receiving CME credit for this activity. During the period January 15, 2011 through January 31, 2012, participants must read the learning objectives and faculty disclosures and study the educational activity.

PIM supports Green CME by offering your Request for Credit online. If you wish to receive acknowledgment for completing this activity, please complete the post‐test and evaluation on www.cmeuniversity.com. On the navigation menu, click on Find Post‐test/Evaluation by Course and search by course ID 6903. Upon registering and successfully completing the post‐test with a score of 70% or better and the activity evaluation, your certificate will be made available immediately. Processing credit requests online will reduce the amount of paper used by nearly 100,000 sheets per year.

Media:

Journal supplement

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

Clinicians want to use antimicrobials as effectively as possible, but good intentions frequently fail to translate into adherence to best available evidence. This was recognized as early as 1956, when Earnest Jawetz noted that [The physician] is under great pressure to prescribe the newest, best, broadest antibiotic preparation, prescribe it for any complaint whatever, quickly, and preferably without worrying too much about specific etiologic diagnosis or proper indication of the drug.1 That was true in 1956, and is more so in 2010.

The term that has come to describe the collection of practices intended to optimize antimicrobial therapy is antimicrobial stewardship. The label is a relatively new one; it appears to have been coined in the mid‐1990s, and has slowly crept into the medical lexicon since then. However, many clinicians remain uncertain of exactly what antimicrobial stewardship means or what practices characterize it. The 2007 Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) guidelines for developing institutional programs to enhance antimicrobial use define antimicrobial stewardship as an activity that includes appropriate selection, dosing, route, and duration of antimicrobial therapy, with a primary goal of optimizing clinical outcomes while minimizing unintended consequences of antimicrobial use.2

In 2004, IDSA published a document titled Bad Bugs, No Drugs that noted a marked decrease in research and development of new antimicrobials within the pharmaceutical industry, at the same time that the number of antibiotic‐resistant bacteria was dramatically increasing, particularly within healthcare settings.3, 4 Since that time, trends in antimicrobial drug development have not appreciably improved, and governmental agencies have been largely silent or ineffective in addressing the problem.58 The growth of multidrug‐resistant and sometimes pan‐resistant pathogens, at a time when newer agents with novel mechanisms of action are not available nor expected for years to come, is particularly troublesome. This scenario highlights the necessity of using currently available agents in a manner that prolongs their effectiveness and reduces further emergence and spread of resistant pathogensie, the crucial need for improved antimicrobial stewardship.

Antimicrobial stewardship recognizes that antimicrobials are a unique category of drugs, with potential to affect treatment outcomes in patients for whom the drug was not originally intended. For example, cardiac and oncologic medications can be costly, and may certainly be toxic, but their effects are limited to the patient that directly receives them. In contrast, the effects of antimicrobials prescribed to a patient in the hospital (or outside the hospital, for that matter), can ripple across the hospital system and beyond. This reflects the fact that suboptimal use of antimicrobials may induce or otherwise promote the development of antimicrobial‐resistant pathogens, with potential wide‐ranging impact.9, 10 Misuse or overuse of antimicrobials can also promote colonization and overgrowth of potentially toxic pathogens within hospitalized patients, such as Clostridium difficile, that may then be transferred widely within the hospital or other healthcare institutions, particularly when infection control measures are also less than optimal. This unique societal feature of antimicrobial drugs highlights the vital importance of antimicrobial stewardship within the hospital setting, especially at a time when few novel agents exist in the developmental pipeline, at least for gram‐negative pathogens.

Are hospitalists stakeholders in this? The answer is a resounding Yes, for several reasons. Hospitalists are the dominant prescribers of antibiotics and other antimicrobials in the United States, almost certainly prescribing more antibiotics in the hospital setting than infectious disease specialists, intensivists, or any other medical specialty or subspecialty. As such, hospitalists play a central role in the optimization of antimicrobial use in the hospital setting, including minimizing negative consequences arising from antimicrobial drug misuse or overuse. In addition, the role hospitalists play in this process is likely to increase in the future. The field of hospital medicine has grown from modest beginnings in the mid‐1990s to approximately 30,000 hospitalists in the United States today.11 Based on a sample of Medicare beneficiaries, 6% of general internists were identified as hospitalists in 1995 versus 19% in 2006, and the percentage of claims for inpatient services provided by general internists who were hospitalists increased from 9% to 37%.12 Current estimates are that >50% of medical inpatients in the United States are cared for by hospitalists (personal communication, J. Miller, Society of Hospital Medicine). Importantly, hospitalists manage patients not only on regular medical floors, but also in intensive care units (ICUs), where antimicrobial resistance is a particular problem.13, 14 Finally, hospitalists serve as gatekeepers for patients leaving the hospital on either oral or intravenous antibiotics or other antimicrobials. As such, via interactions with primary care physicians, hospitalists can play a key role in improving antimicrobial stewardship not only within, but also beyond, the hospital setting.

Hospital medicine is the first medical specialty to make patient safety and quality improvement central principles of its practice, and antimicrobial stewardship is an under‐recognized but central tenet of patient safety. As a consequence, hospitalists are natural allies of stewardship programs. Indeed, antimicrobial stewardship may be considered an example of the Holy Grail of quality improvement; ie, an intervention that improves outcomes while leading to cost savings, and should thus resonate with all hospitalists.

A number of clinical practice guidelines or campaigns have been developed by professional societies and governmental organizations in the United States2, 1526 and other countries2730 for the promotion of improved antimicrobial stewardship and/or infection control in hospitals and long‐term care facilities. The goals of these initiatives, campaigns, or guidelines are to provide information that can be utilized to prevent or slow the development and spread of hospital‐acquired infections, particularly those involving antimicrobial‐resistant pathogens. In addition, the United States Congress is currently considering the STAAR (Strategies to Address Antimicrobial Resistance) Act to encourage the use of innovative governmental and private approaches to combat this critical and expanding problem.31

This supplement to the Journal of Hospital Medicine contains several articles of interest to hospitalists seeking to positively impact patient care through improvements in antimicrobial stewardship. The first article by Christopher Ohl, MD, examines general principles of antimicrobial stewardship programs as they apply to inpatient facilities. The second article by Thomas Lodise, PharmD, explores the effective use of pharmacokinetic‐pharmacodynamic principles in antimicrobial stewardship. In the third article, Steven Gordon, MD, moves beyond the hospital setting to discuss antimicrobial stewardship at the time of hospital discharge and beyond. Finally, Arjun Srinivasan, MD, outlines several practical ways in which hospitalists may take leadership roles in stewardship efforts at their institutions. Our hope is that the supplement will be thought‐provoking, and ultimately lead to greater partnership between hospitalists and other stakeholders in antimicrobial stewardship.

Clinicians want to use antimicrobials as effectively as possible, but good intentions frequently fail to translate into adherence to best available evidence. This was recognized as early as 1956, when Earnest Jawetz noted that [The physician] is under great pressure to prescribe the newest, best, broadest antibiotic preparation, prescribe it for any complaint whatever, quickly, and preferably without worrying too much about specific etiologic diagnosis or proper indication of the drug.1 That was true in 1956, and is more so in 2010.

The term that has come to describe the collection of practices intended to optimize antimicrobial therapy is antimicrobial stewardship. The label is a relatively new one; it appears to have been coined in the mid‐1990s, and has slowly crept into the medical lexicon since then. However, many clinicians remain uncertain of exactly what antimicrobial stewardship means or what practices characterize it. The 2007 Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) guidelines for developing institutional programs to enhance antimicrobial use define antimicrobial stewardship as an activity that includes appropriate selection, dosing, route, and duration of antimicrobial therapy, with a primary goal of optimizing clinical outcomes while minimizing unintended consequences of antimicrobial use.2

In 2004, IDSA published a document titled Bad Bugs, No Drugs that noted a marked decrease in research and development of new antimicrobials within the pharmaceutical industry, at the same time that the number of antibiotic‐resistant bacteria was dramatically increasing, particularly within healthcare settings.3, 4 Since that time, trends in antimicrobial drug development have not appreciably improved, and governmental agencies have been largely silent or ineffective in addressing the problem.58 The growth of multidrug‐resistant and sometimes pan‐resistant pathogens, at a time when newer agents with novel mechanisms of action are not available nor expected for years to come, is particularly troublesome. This scenario highlights the necessity of using currently available agents in a manner that prolongs their effectiveness and reduces further emergence and spread of resistant pathogensie, the crucial need for improved antimicrobial stewardship.

Antimicrobial stewardship recognizes that antimicrobials are a unique category of drugs, with potential to affect treatment outcomes in patients for whom the drug was not originally intended. For example, cardiac and oncologic medications can be costly, and may certainly be toxic, but their effects are limited to the patient that directly receives them. In contrast, the effects of antimicrobials prescribed to a patient in the hospital (or outside the hospital, for that matter), can ripple across the hospital system and beyond. This reflects the fact that suboptimal use of antimicrobials may induce or otherwise promote the development of antimicrobial‐resistant pathogens, with potential wide‐ranging impact.9, 10 Misuse or overuse of antimicrobials can also promote colonization and overgrowth of potentially toxic pathogens within hospitalized patients, such as Clostridium difficile, that may then be transferred widely within the hospital or other healthcare institutions, particularly when infection control measures are also less than optimal. This unique societal feature of antimicrobial drugs highlights the vital importance of antimicrobial stewardship within the hospital setting, especially at a time when few novel agents exist in the developmental pipeline, at least for gram‐negative pathogens.

Are hospitalists stakeholders in this? The answer is a resounding Yes, for several reasons. Hospitalists are the dominant prescribers of antibiotics and other antimicrobials in the United States, almost certainly prescribing more antibiotics in the hospital setting than infectious disease specialists, intensivists, or any other medical specialty or subspecialty. As such, hospitalists play a central role in the optimization of antimicrobial use in the hospital setting, including minimizing negative consequences arising from antimicrobial drug misuse or overuse. In addition, the role hospitalists play in this process is likely to increase in the future. The field of hospital medicine has grown from modest beginnings in the mid‐1990s to approximately 30,000 hospitalists in the United States today.11 Based on a sample of Medicare beneficiaries, 6% of general internists were identified as hospitalists in 1995 versus 19% in 2006, and the percentage of claims for inpatient services provided by general internists who were hospitalists increased from 9% to 37%.12 Current estimates are that >50% of medical inpatients in the United States are cared for by hospitalists (personal communication, J. Miller, Society of Hospital Medicine). Importantly, hospitalists manage patients not only on regular medical floors, but also in intensive care units (ICUs), where antimicrobial resistance is a particular problem.13, 14 Finally, hospitalists serve as gatekeepers for patients leaving the hospital on either oral or intravenous antibiotics or other antimicrobials. As such, via interactions with primary care physicians, hospitalists can play a key role in improving antimicrobial stewardship not only within, but also beyond, the hospital setting.

Hospital medicine is the first medical specialty to make patient safety and quality improvement central principles of its practice, and antimicrobial stewardship is an under‐recognized but central tenet of patient safety. As a consequence, hospitalists are natural allies of stewardship programs. Indeed, antimicrobial stewardship may be considered an example of the Holy Grail of quality improvement; ie, an intervention that improves outcomes while leading to cost savings, and should thus resonate with all hospitalists.

A number of clinical practice guidelines or campaigns have been developed by professional societies and governmental organizations in the United States2, 1526 and other countries2730 for the promotion of improved antimicrobial stewardship and/or infection control in hospitals and long‐term care facilities. The goals of these initiatives, campaigns, or guidelines are to provide information that can be utilized to prevent or slow the development and spread of hospital‐acquired infections, particularly those involving antimicrobial‐resistant pathogens. In addition, the United States Congress is currently considering the STAAR (Strategies to Address Antimicrobial Resistance) Act to encourage the use of innovative governmental and private approaches to combat this critical and expanding problem.31

This supplement to the Journal of Hospital Medicine contains several articles of interest to hospitalists seeking to positively impact patient care through improvements in antimicrobial stewardship. The first article by Christopher Ohl, MD, examines general principles of antimicrobial stewardship programs as they apply to inpatient facilities. The second article by Thomas Lodise, PharmD, explores the effective use of pharmacokinetic‐pharmacodynamic principles in antimicrobial stewardship. In the third article, Steven Gordon, MD, moves beyond the hospital setting to discuss antimicrobial stewardship at the time of hospital discharge and beyond. Finally, Arjun Srinivasan, MD, outlines several practical ways in which hospitalists may take leadership roles in stewardship efforts at their institutions. Our hope is that the supplement will be thought‐provoking, and ultimately lead to greater partnership between hospitalists and other stakeholders in antimicrobial stewardship.

Clinicians want to use antimicrobials as effectively as possible, but good intentions frequently fail to translate into adherence to best available evidence. This was recognized as early as 1956, when Earnest Jawetz noted that [The physician] is under great pressure to prescribe the newest, best, broadest antibiotic preparation, prescribe it for any complaint whatever, quickly, and preferably without worrying too much about specific etiologic diagnosis or proper indication of the drug.1 That was true in 1956, and is more so in 2010.

The term that has come to describe the collection of practices intended to optimize antimicrobial therapy is antimicrobial stewardship. The label is a relatively new one; it appears to have been coined in the mid‐1990s, and has slowly crept into the medical lexicon since then. However, many clinicians remain uncertain of exactly what antimicrobial stewardship means or what practices characterize it. The 2007 Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) guidelines for developing institutional programs to enhance antimicrobial use define antimicrobial stewardship as an activity that includes appropriate selection, dosing, route, and duration of antimicrobial therapy, with a primary goal of optimizing clinical outcomes while minimizing unintended consequences of antimicrobial use.2

In 2004, IDSA published a document titled Bad Bugs, No Drugs that noted a marked decrease in research and development of new antimicrobials within the pharmaceutical industry, at the same time that the number of antibiotic‐resistant bacteria was dramatically increasing, particularly within healthcare settings.3, 4 Since that time, trends in antimicrobial drug development have not appreciably improved, and governmental agencies have been largely silent or ineffective in addressing the problem.58 The growth of multidrug‐resistant and sometimes pan‐resistant pathogens, at a time when newer agents with novel mechanisms of action are not available nor expected for years to come, is particularly troublesome. This scenario highlights the necessity of using currently available agents in a manner that prolongs their effectiveness and reduces further emergence and spread of resistant pathogensie, the crucial need for improved antimicrobial stewardship.

Antimicrobial stewardship recognizes that antimicrobials are a unique category of drugs, with potential to affect treatment outcomes in patients for whom the drug was not originally intended. For example, cardiac and oncologic medications can be costly, and may certainly be toxic, but their effects are limited to the patient that directly receives them. In contrast, the effects of antimicrobials prescribed to a patient in the hospital (or outside the hospital, for that matter), can ripple across the hospital system and beyond. This reflects the fact that suboptimal use of antimicrobials may induce or otherwise promote the development of antimicrobial‐resistant pathogens, with potential wide‐ranging impact.9, 10 Misuse or overuse of antimicrobials can also promote colonization and overgrowth of potentially toxic pathogens within hospitalized patients, such as Clostridium difficile, that may then be transferred widely within the hospital or other healthcare institutions, particularly when infection control measures are also less than optimal. This unique societal feature of antimicrobial drugs highlights the vital importance of antimicrobial stewardship within the hospital setting, especially at a time when few novel agents exist in the developmental pipeline, at least for gram‐negative pathogens.

Are hospitalists stakeholders in this? The answer is a resounding Yes, for several reasons. Hospitalists are the dominant prescribers of antibiotics and other antimicrobials in the United States, almost certainly prescribing more antibiotics in the hospital setting than infectious disease specialists, intensivists, or any other medical specialty or subspecialty. As such, hospitalists play a central role in the optimization of antimicrobial use in the hospital setting, including minimizing negative consequences arising from antimicrobial drug misuse or overuse. In addition, the role hospitalists play in this process is likely to increase in the future. The field of hospital medicine has grown from modest beginnings in the mid‐1990s to approximately 30,000 hospitalists in the United States today.11 Based on a sample of Medicare beneficiaries, 6% of general internists were identified as hospitalists in 1995 versus 19% in 2006, and the percentage of claims for inpatient services provided by general internists who were hospitalists increased from 9% to 37%.12 Current estimates are that >50% of medical inpatients in the United States are cared for by hospitalists (personal communication, J. Miller, Society of Hospital Medicine). Importantly, hospitalists manage patients not only on regular medical floors, but also in intensive care units (ICUs), where antimicrobial resistance is a particular problem.13, 14 Finally, hospitalists serve as gatekeepers for patients leaving the hospital on either oral or intravenous antibiotics or other antimicrobials. As such, via interactions with primary care physicians, hospitalists can play a key role in improving antimicrobial stewardship not only within, but also beyond, the hospital setting.

Hospital medicine is the first medical specialty to make patient safety and quality improvement central principles of its practice, and antimicrobial stewardship is an under‐recognized but central tenet of patient safety. As a consequence, hospitalists are natural allies of stewardship programs. Indeed, antimicrobial stewardship may be considered an example of the Holy Grail of quality improvement; ie, an intervention that improves outcomes while leading to cost savings, and should thus resonate with all hospitalists.

A number of clinical practice guidelines or campaigns have been developed by professional societies and governmental organizations in the United States2, 1526 and other countries2730 for the promotion of improved antimicrobial stewardship and/or infection control in hospitals and long‐term care facilities. The goals of these initiatives, campaigns, or guidelines are to provide information that can be utilized to prevent or slow the development and spread of hospital‐acquired infections, particularly those involving antimicrobial‐resistant pathogens. In addition, the United States Congress is currently considering the STAAR (Strategies to Address Antimicrobial Resistance) Act to encourage the use of innovative governmental and private approaches to combat this critical and expanding problem.31

This supplement to the Journal of Hospital Medicine contains several articles of interest to hospitalists seeking to positively impact patient care through improvements in antimicrobial stewardship. The first article by Christopher Ohl, MD, examines general principles of antimicrobial stewardship programs as they apply to inpatient facilities. The second article by Thomas Lodise, PharmD, explores the effective use of pharmacokinetic‐pharmacodynamic principles in antimicrobial stewardship. In the third article, Steven Gordon, MD, moves beyond the hospital setting to discuss antimicrobial stewardship at the time of hospital discharge and beyond. Finally, Arjun Srinivasan, MD, outlines several practical ways in which hospitalists may take leadership roles in stewardship efforts at their institutions. Our hope is that the supplement will be thought‐provoking, and ultimately lead to greater partnership between hospitalists and other stakeholders in antimicrobial stewardship.

What if there was a quality improvement initiative that had been proven in multiple, peer‐reviewed publications to improve individual patient outcomes, reduce the overall burden of antimicrobial resistance, and save healthcare dollars? Surely such an initiative would enjoy widespread, if not uniform, adoption by health care facilities. Antimicrobial stewardship is just such an intervention. Ensuring that hospitalized patients receive the right antimicrobial, at the right dose, at the right time, and for the right duration has been shown to reduce mortality,1 reduce the risks of Clostridium difficileassociated diarrhea,2 shorten length of stay,3 reduce overall antimicrobial resistance within the facility,4 and save money.5 Yet despite these benefits, antimicrobial stewardship programs and interventions are far from the norm in US hospitals.

There are 2 important myths about antimicrobial stewardship that likely contribute substantially to the gap between the recognized benefits and implementation of stewardship interventions. Dispelling these myths is a crucial step in promoting wider adoption efforts to improve antimicrobial use. The first myth stems from the very name antimicrobial stewardship program, which has created a misperception that optimal inpatient antimicrobial use is only possible in settings with formal stewardship programs that are staffed by infectious diseases (ID) physicians and pharmacist. The best guidelines on implementing stewardship programs, developed by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America,6 may have contributed to this misperception by suggesting that optimal programs require dedicated time from both an ID physician and an ID‐trained pharmacist. However, many hospitals do not have ID physicians on staff, and the vast majority do not have access to an ID pharmacist who is comfortable with antimicrobial stewardship. Although these traditionally staffed programs have well‐proven benefits and are an excellent goal, they are not feasible in many hospitals. However, different types of stewardship interventions, led by a variety of health care providers and specialists, also have well‐proven benefits. Although these latter experiences are much less likely to appear in peer‐reviewed medical journals, experts in antimicrobial stewardship indicate that they often hear about very successful stewardship interventions being led by groups like general clinical pharmacists, intensivists, and hospitalists. Workshops on antimicrobial stewardship are often full of attendees who are successfully improving antimicrobial use in facilities that represent the full spectrum of US hospitals: large and small, urban and rural, teaching and nonteaching. Indeed, I prefer the term antimicrobial stewardship programs and interventions to convey that improving antimicrobial use can be done, and done well, even without the ideally staffed program.

The second myth is that the only goal of stewardship programs and interventions is to stop clinicians from using antimicrobials. This misperception has led to counterproductive attitudes toward stewardship programs and interventions in some facilities. Without question, stopping unnecessary antimicrobial use is an important aspect of stewardship interventions that has well‐established benefits for patients and hospitals. That one third to one half of all inpatient antimicrobial use might be unnecessary, combined with the growing problem of C. difficile, certainly supports the goal of reducing inappropriate antimicrobial use. However, the primary goal of stewardship is to optimize antimicrobial therapy. In many instances, this does involve stopping unneeded antimicrobials, and because stopping antibiotics has the most readily demonstrable benefits on patient and financial outcomes, interventions with this aim are the subject of nearly all published studies. However, anyone who has worked on stewardship interventions can describe numerous instances when the recommendation provided was to broaden or lengthen antimicrobial therapy. Moreover, surveys indicate that, far from viewing stewardship as an intrusion or infringement on their autonomy, clinicians appreciate and even want the assistance that these efforts provide.7

If stewardship has substantial proven benefits, can be implemented in nearly any hospital setting, and is welcomed by providers, what can be done to move toward broader implementation? I believe that engaging hospitalists more fully in stewardship efforts will be a critical step in this direction. Hospitalists already provide a substantial portion of all inpatient care in the United States, and the numbers of hospitalists are growing rapidly. Moreover, they are increasingly taking the lead in a variety of quality improvement initiatives. Hence, hospitalists are ideally positioned and well suited to move stewardship efforts forward. Some, including hospitalists, have also suggested that developing a practical stewardship implementation framework would be helpful in promoting these interventions.

This suggestion has led the Centers for Disease Control and Prevention's (CDC) Get Smart for Healthcare campaign to partner with the Institute for Healthcare Improvement (IHI) and a variety of external experts (including a hospitalist) to develop such a framework using the IHI's Driver Diagram and Change Package methodology. The driver diagram seeks to identify a core set of highly influential practices that lead to a desired outcome. For optimizing antimicrobial use, the primary drivers that were identified by experts include: 1) timely and appropriate initiation of antibiotics; 2) appropriate administration and de‐escalation of therapy; 3) data monitoring and transparency (measuring and feeding back to clinicians data on antimicrobial use and resistance); and 4) improving stewardship infrastructure, knowledge, and engagement in antimicrobial stewardship efforts. Once these drivers were identified, the expert panel then identified a number of specific practices, or change concepts, that would support progress toward each driver. Now that the Driver Diagram and Change Package has been drafted, the CDC and IHI are collaborating on a pilot testing effort and are working to ensure that a substantial number of the pilot projects are led by hospitalists. Our goal is that the Driver Diagram and Change Package will be honed and refined with the help of hospitalists so that the end result will be a highly implementable set of antimicrobial stewardship interventions that can be widely applied by hospitalists around the country.

However, we need not wait for finalization of the Driver Diagram and Change Package to begin a productive collaboration on antimicrobial stewardship. In addition to the project with IHI, Get Smart for Healthcare is working to identify a variety of resources that would be useful in implementing and improving stewardship efforts. To that end, we would love to hear from any hospitalists who would like to share their experiences with stewardship interventions or who have tools (eg, order sets), ideas (eg, particularly successful intervention projects), or success stories. They can be e‐mailed to [email protected].

For now, I would like to suggest that there are 4 antibiotic quality improvement projects hospitalists would be ideally suited to lead. The first is ensuring that all antibiotic orders include a Dose, Duration, Indication. Efforts to improve antibiotic use are often hampered because the nonprescribing providers are not sure why the patient is on antibiotics. This problem is amplified when patients are transitioned from one provider to another or when multiple providers are involved. Specifying the duration and indication in all antibiotic orders will ensure that treatments continue for the right amount of time and would allow therapy to be stopped if the initially suspected infection is ruled out or altered if another infection is identified. The second improvement project is developing a process to ensure that any patient with a positive blood culture is on the appropriate therapy. This is a relatively straightforward intervention that is based on the patient's own microbiology results, and it ensures the optimal therapy of a serious infection. Third is the development of an intervention to encourage the reassessment of patients who are started on antibiotics for community‐acquired pneumonia (CAP). Several hospitalists have suggested that the pressure to initiate therapy quickly in cases of CAP often leads to overtreatment. Interventions that encourage a reexamination of the CAP diagnosis when the clinical situation has stabilized would likely reduce this overtreatment. And the fourth improvement project is ensuring that urinary tract infections (UTIs) in hospitalized patients are properly diagnosed and treated. Work done by hospitalists at the University of Michigan suggests that improving the diagnosis and treatment of UTIs would have a significant impact on improving antibiotic use.8 Currently, the CDC is collaborating with these investigators to develop protocols and tools to improve the treatment of inpatient UTIs.

The time to promote aggressive implementation of antimicrobial stewardship interventions has come. Clinicians are increasingly encountering infections for which there are very limited or, in some cases, no good treatment optionsand there are very few new antibiotics on the horizon. Many groups are advocating for expanded efforts to develop new antibiotics.9 Although this is crucial, it is just as important that we work now to aggressively improve the use of the agents we have. Not only might this extend the life of our current agents, but it will also help ensure that any new agents will enjoy longer periods of effectiveness. Indeed, failing to inextricably link the development of new antibiotics with efforts to improve antibiotic use is akin to buying a new car to drive on a road full of potholes. Fortunately, there are a number of interventions that have proven successful; we now need to determine how best to apply these interventions in more settings. We want and need the involvement of hospitalists in these efforts. Yes, improving antimicrobial stewardship will require investments, but past experience tells us that the alternative could prove far more costly.

What if there was a quality improvement initiative that had been proven in multiple, peer‐reviewed publications to improve individual patient outcomes, reduce the overall burden of antimicrobial resistance, and save healthcare dollars? Surely such an initiative would enjoy widespread, if not uniform, adoption by health care facilities. Antimicrobial stewardship is just such an intervention. Ensuring that hospitalized patients receive the right antimicrobial, at the right dose, at the right time, and for the right duration has been shown to reduce mortality,1 reduce the risks of Clostridium difficileassociated diarrhea,2 shorten length of stay,3 reduce overall antimicrobial resistance within the facility,4 and save money.5 Yet despite these benefits, antimicrobial stewardship programs and interventions are far from the norm in US hospitals.

There are 2 important myths about antimicrobial stewardship that likely contribute substantially to the gap between the recognized benefits and implementation of stewardship interventions. Dispelling these myths is a crucial step in promoting wider adoption efforts to improve antimicrobial use. The first myth stems from the very name antimicrobial stewardship program, which has created a misperception that optimal inpatient antimicrobial use is only possible in settings with formal stewardship programs that are staffed by infectious diseases (ID) physicians and pharmacist. The best guidelines on implementing stewardship programs, developed by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America,6 may have contributed to this misperception by suggesting that optimal programs require dedicated time from both an ID physician and an ID‐trained pharmacist. However, many hospitals do not have ID physicians on staff, and the vast majority do not have access to an ID pharmacist who is comfortable with antimicrobial stewardship. Although these traditionally staffed programs have well‐proven benefits and are an excellent goal, they are not feasible in many hospitals. However, different types of stewardship interventions, led by a variety of health care providers and specialists, also have well‐proven benefits. Although these latter experiences are much less likely to appear in peer‐reviewed medical journals, experts in antimicrobial stewardship indicate that they often hear about very successful stewardship interventions being led by groups like general clinical pharmacists, intensivists, and hospitalists. Workshops on antimicrobial stewardship are often full of attendees who are successfully improving antimicrobial use in facilities that represent the full spectrum of US hospitals: large and small, urban and rural, teaching and nonteaching. Indeed, I prefer the term antimicrobial stewardship programs and interventions to convey that improving antimicrobial use can be done, and done well, even without the ideally staffed program.

The second myth is that the only goal of stewardship programs and interventions is to stop clinicians from using antimicrobials. This misperception has led to counterproductive attitudes toward stewardship programs and interventions in some facilities. Without question, stopping unnecessary antimicrobial use is an important aspect of stewardship interventions that has well‐established benefits for patients and hospitals. That one third to one half of all inpatient antimicrobial use might be unnecessary, combined with the growing problem of C. difficile, certainly supports the goal of reducing inappropriate antimicrobial use. However, the primary goal of stewardship is to optimize antimicrobial therapy. In many instances, this does involve stopping unneeded antimicrobials, and because stopping antibiotics has the most readily demonstrable benefits on patient and financial outcomes, interventions with this aim are the subject of nearly all published studies. However, anyone who has worked on stewardship interventions can describe numerous instances when the recommendation provided was to broaden or lengthen antimicrobial therapy. Moreover, surveys indicate that, far from viewing stewardship as an intrusion or infringement on their autonomy, clinicians appreciate and even want the assistance that these efforts provide.7

If stewardship has substantial proven benefits, can be implemented in nearly any hospital setting, and is welcomed by providers, what can be done to move toward broader implementation? I believe that engaging hospitalists more fully in stewardship efforts will be a critical step in this direction. Hospitalists already provide a substantial portion of all inpatient care in the United States, and the numbers of hospitalists are growing rapidly. Moreover, they are increasingly taking the lead in a variety of quality improvement initiatives. Hence, hospitalists are ideally positioned and well suited to move stewardship efforts forward. Some, including hospitalists, have also suggested that developing a practical stewardship implementation framework would be helpful in promoting these interventions.

This suggestion has led the Centers for Disease Control and Prevention's (CDC) Get Smart for Healthcare campaign to partner with the Institute for Healthcare Improvement (IHI) and a variety of external experts (including a hospitalist) to develop such a framework using the IHI's Driver Diagram and Change Package methodology. The driver diagram seeks to identify a core set of highly influential practices that lead to a desired outcome. For optimizing antimicrobial use, the primary drivers that were identified by experts include: 1) timely and appropriate initiation of antibiotics; 2) appropriate administration and de‐escalation of therapy; 3) data monitoring and transparency (measuring and feeding back to clinicians data on antimicrobial use and resistance); and 4) improving stewardship infrastructure, knowledge, and engagement in antimicrobial stewardship efforts. Once these drivers were identified, the expert panel then identified a number of specific practices, or change concepts, that would support progress toward each driver. Now that the Driver Diagram and Change Package has been drafted, the CDC and IHI are collaborating on a pilot testing effort and are working to ensure that a substantial number of the pilot projects are led by hospitalists. Our goal is that the Driver Diagram and Change Package will be honed and refined with the help of hospitalists so that the end result will be a highly implementable set of antimicrobial stewardship interventions that can be widely applied by hospitalists around the country.

However, we need not wait for finalization of the Driver Diagram and Change Package to begin a productive collaboration on antimicrobial stewardship. In addition to the project with IHI, Get Smart for Healthcare is working to identify a variety of resources that would be useful in implementing and improving stewardship efforts. To that end, we would love to hear from any hospitalists who would like to share their experiences with stewardship interventions or who have tools (eg, order sets), ideas (eg, particularly successful intervention projects), or success stories. They can be e‐mailed to [email protected].

For now, I would like to suggest that there are 4 antibiotic quality improvement projects hospitalists would be ideally suited to lead. The first is ensuring that all antibiotic orders include a Dose, Duration, Indication. Efforts to improve antibiotic use are often hampered because the nonprescribing providers are not sure why the patient is on antibiotics. This problem is amplified when patients are transitioned from one provider to another or when multiple providers are involved. Specifying the duration and indication in all antibiotic orders will ensure that treatments continue for the right amount of time and would allow therapy to be stopped if the initially suspected infection is ruled out or altered if another infection is identified. The second improvement project is developing a process to ensure that any patient with a positive blood culture is on the appropriate therapy. This is a relatively straightforward intervention that is based on the patient's own microbiology results, and it ensures the optimal therapy of a serious infection. Third is the development of an intervention to encourage the reassessment of patients who are started on antibiotics for community‐acquired pneumonia (CAP). Several hospitalists have suggested that the pressure to initiate therapy quickly in cases of CAP often leads to overtreatment. Interventions that encourage a reexamination of the CAP diagnosis when the clinical situation has stabilized would likely reduce this overtreatment. And the fourth improvement project is ensuring that urinary tract infections (UTIs) in hospitalized patients are properly diagnosed and treated. Work done by hospitalists at the University of Michigan suggests that improving the diagnosis and treatment of UTIs would have a significant impact on improving antibiotic use.8 Currently, the CDC is collaborating with these investigators to develop protocols and tools to improve the treatment of inpatient UTIs.

The time to promote aggressive implementation of antimicrobial stewardship interventions has come. Clinicians are increasingly encountering infections for which there are very limited or, in some cases, no good treatment optionsand there are very few new antibiotics on the horizon. Many groups are advocating for expanded efforts to develop new antibiotics.9 Although this is crucial, it is just as important that we work now to aggressively improve the use of the agents we have. Not only might this extend the life of our current agents, but it will also help ensure that any new agents will enjoy longer periods of effectiveness. Indeed, failing to inextricably link the development of new antibiotics with efforts to improve antibiotic use is akin to buying a new car to drive on a road full of potholes. Fortunately, there are a number of interventions that have proven successful; we now need to determine how best to apply these interventions in more settings. We want and need the involvement of hospitalists in these efforts. Yes, improving antimicrobial stewardship will require investments, but past experience tells us that the alternative could prove far more costly.

What if there was a quality improvement initiative that had been proven in multiple, peer‐reviewed publications to improve individual patient outcomes, reduce the overall burden of antimicrobial resistance, and save healthcare dollars? Surely such an initiative would enjoy widespread, if not uniform, adoption by health care facilities. Antimicrobial stewardship is just such an intervention. Ensuring that hospitalized patients receive the right antimicrobial, at the right dose, at the right time, and for the right duration has been shown to reduce mortality,1 reduce the risks of Clostridium difficileassociated diarrhea,2 shorten length of stay,3 reduce overall antimicrobial resistance within the facility,4 and save money.5 Yet despite these benefits, antimicrobial stewardship programs and interventions are far from the norm in US hospitals.

There are 2 important myths about antimicrobial stewardship that likely contribute substantially to the gap between the recognized benefits and implementation of stewardship interventions. Dispelling these myths is a crucial step in promoting wider adoption efforts to improve antimicrobial use. The first myth stems from the very name antimicrobial stewardship program, which has created a misperception that optimal inpatient antimicrobial use is only possible in settings with formal stewardship programs that are staffed by infectious diseases (ID) physicians and pharmacist. The best guidelines on implementing stewardship programs, developed by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America,6 may have contributed to this misperception by suggesting that optimal programs require dedicated time from both an ID physician and an ID‐trained pharmacist. However, many hospitals do not have ID physicians on staff, and the vast majority do not have access to an ID pharmacist who is comfortable with antimicrobial stewardship. Although these traditionally staffed programs have well‐proven benefits and are an excellent goal, they are not feasible in many hospitals. However, different types of stewardship interventions, led by a variety of health care providers and specialists, also have well‐proven benefits. Although these latter experiences are much less likely to appear in peer‐reviewed medical journals, experts in antimicrobial stewardship indicate that they often hear about very successful stewardship interventions being led by groups like general clinical pharmacists, intensivists, and hospitalists. Workshops on antimicrobial stewardship are often full of attendees who are successfully improving antimicrobial use in facilities that represent the full spectrum of US hospitals: large and small, urban and rural, teaching and nonteaching. Indeed, I prefer the term antimicrobial stewardship programs and interventions to convey that improving antimicrobial use can be done, and done well, even without the ideally staffed program.

The second myth is that the only goal of stewardship programs and interventions is to stop clinicians from using antimicrobials. This misperception has led to counterproductive attitudes toward stewardship programs and interventions in some facilities. Without question, stopping unnecessary antimicrobial use is an important aspect of stewardship interventions that has well‐established benefits for patients and hospitals. That one third to one half of all inpatient antimicrobial use might be unnecessary, combined with the growing problem of C. difficile, certainly supports the goal of reducing inappropriate antimicrobial use. However, the primary goal of stewardship is to optimize antimicrobial therapy. In many instances, this does involve stopping unneeded antimicrobials, and because stopping antibiotics has the most readily demonstrable benefits on patient and financial outcomes, interventions with this aim are the subject of nearly all published studies. However, anyone who has worked on stewardship interventions can describe numerous instances when the recommendation provided was to broaden or lengthen antimicrobial therapy. Moreover, surveys indicate that, far from viewing stewardship as an intrusion or infringement on their autonomy, clinicians appreciate and even want the assistance that these efforts provide.7

If stewardship has substantial proven benefits, can be implemented in nearly any hospital setting, and is welcomed by providers, what can be done to move toward broader implementation? I believe that engaging hospitalists more fully in stewardship efforts will be a critical step in this direction. Hospitalists already provide a substantial portion of all inpatient care in the United States, and the numbers of hospitalists are growing rapidly. Moreover, they are increasingly taking the lead in a variety of quality improvement initiatives. Hence, hospitalists are ideally positioned and well suited to move stewardship efforts forward. Some, including hospitalists, have also suggested that developing a practical stewardship implementation framework would be helpful in promoting these interventions.

This suggestion has led the Centers for Disease Control and Prevention's (CDC) Get Smart for Healthcare campaign to partner with the Institute for Healthcare Improvement (IHI) and a variety of external experts (including a hospitalist) to develop such a framework using the IHI's Driver Diagram and Change Package methodology. The driver diagram seeks to identify a core set of highly influential practices that lead to a desired outcome. For optimizing antimicrobial use, the primary drivers that were identified by experts include: 1) timely and appropriate initiation of antibiotics; 2) appropriate administration and de‐escalation of therapy; 3) data monitoring and transparency (measuring and feeding back to clinicians data on antimicrobial use and resistance); and 4) improving stewardship infrastructure, knowledge, and engagement in antimicrobial stewardship efforts. Once these drivers were identified, the expert panel then identified a number of specific practices, or change concepts, that would support progress toward each driver. Now that the Driver Diagram and Change Package has been drafted, the CDC and IHI are collaborating on a pilot testing effort and are working to ensure that a substantial number of the pilot projects are led by hospitalists. Our goal is that the Driver Diagram and Change Package will be honed and refined with the help of hospitalists so that the end result will be a highly implementable set of antimicrobial stewardship interventions that can be widely applied by hospitalists around the country.

However, we need not wait for finalization of the Driver Diagram and Change Package to begin a productive collaboration on antimicrobial stewardship. In addition to the project with IHI, Get Smart for Healthcare is working to identify a variety of resources that would be useful in implementing and improving stewardship efforts. To that end, we would love to hear from any hospitalists who would like to share their experiences with stewardship interventions or who have tools (eg, order sets), ideas (eg, particularly successful intervention projects), or success stories. They can be e‐mailed to [email protected].

For now, I would like to suggest that there are 4 antibiotic quality improvement projects hospitalists would be ideally suited to lead. The first is ensuring that all antibiotic orders include a Dose, Duration, Indication. Efforts to improve antibiotic use are often hampered because the nonprescribing providers are not sure why the patient is on antibiotics. This problem is amplified when patients are transitioned from one provider to another or when multiple providers are involved. Specifying the duration and indication in all antibiotic orders will ensure that treatments continue for the right amount of time and would allow therapy to be stopped if the initially suspected infection is ruled out or altered if another infection is identified. The second improvement project is developing a process to ensure that any patient with a positive blood culture is on the appropriate therapy. This is a relatively straightforward intervention that is based on the patient's own microbiology results, and it ensures the optimal therapy of a serious infection. Third is the development of an intervention to encourage the reassessment of patients who are started on antibiotics for community‐acquired pneumonia (CAP). Several hospitalists have suggested that the pressure to initiate therapy quickly in cases of CAP often leads to overtreatment. Interventions that encourage a reexamination of the CAP diagnosis when the clinical situation has stabilized would likely reduce this overtreatment. And the fourth improvement project is ensuring that urinary tract infections (UTIs) in hospitalized patients are properly diagnosed and treated. Work done by hospitalists at the University of Michigan suggests that improving the diagnosis and treatment of UTIs would have a significant impact on improving antibiotic use.8 Currently, the CDC is collaborating with these investigators to develop protocols and tools to improve the treatment of inpatient UTIs.

The time to promote aggressive implementation of antimicrobial stewardship interventions has come. Clinicians are increasingly encountering infections for which there are very limited or, in some cases, no good treatment optionsand there are very few new antibiotics on the horizon. Many groups are advocating for expanded efforts to develop new antibiotics.9 Although this is crucial, it is just as important that we work now to aggressively improve the use of the agents we have. Not only might this extend the life of our current agents, but it will also help ensure that any new agents will enjoy longer periods of effectiveness. Indeed, failing to inextricably link the development of new antibiotics with efforts to improve antibiotic use is akin to buying a new car to drive on a road full of potholes. Fortunately, there are a number of interventions that have proven successful; we now need to determine how best to apply these interventions in more settings. We want and need the involvement of hospitalists in these efforts. Yes, improving antimicrobial stewardship will require investments, but past experience tells us that the alternative could prove far more costly.