Eye on ID

ASPs: Job of a steward, or time for a pilot?

A recently published governmental study estimated that 2 million persons become ill every year with antibiotic-resistant infections, and about 23,000 die. Antibiotics differ from many other pharmaceutical agents, not only by nature of their critical need, but also by their loss of efficacy over time, thereby requiring continual replacement. In essence, unlike other marketed medications, antibiotics are unique in that once these drugs are approved, their use is actually dissuaded in an effort to preserve their utility.

Larry M. Bush

Unfortunately, the increase in antimicrobial resistance is occurring simultaneously with the dramatic reduction in the number of new agents being presented to the FDA for approval. Fewer than 12 new agents have come into clinical practice over the past few decades, and almost no new classes of drugs have been developed to treat gram-negative bacillary infections for more than 40 years. This is no surprise, as the majority of new antimicrobial agent research and development rests with for-profit pharmaceutical companies. Due to the rising costs of new antibiotic development, declining return on investment, and inhibitory governmental regulations, these companies now lack incentive to pursue this line of business and have undertaken more profitable ventures. Further compounding this issue is the FDA’s noninferiority trial design requirement. Recognizing these roadblocks, the Infectious Diseases Society of America published a report in 2013 outlining specific solutions to the development and approval of antimicrobial drugs.

Donald Kaye

Having acknowledged the current state of affairs and the growing crisis of anti-infective chemotherapeutic agents, especially as it relates to the frightening expansion of multidrug-resistant organisms, the question at hand is how do we curtail and hopefully reverse this trend, which may force future physicians to practice medicine in a so-called “post-antibiotic era,” as did their predecessors in the “pre-antibiotic era.” Notwithstanding the knowledge that more than 75% of antimicrobial production is used for feeding animals, we are still left with a significant amount of antibiotic exposure by way of health care provider drug-prescribing practices. For example, in hospitalized patients alone, more than half are receiving antibiotics on any given day. For a host of reasons, there has been an ongoing unwillingness in the medical profession to accept measures for the restraint or control of indiscriminate prescribing of antibiotics. And therein lies the problem.

Various interventions designed to curtail the development of antibiotic resistance in this era of “bad bugs, no drugs” include both changes in agricultural government regulations and the creation of new health care policies. Although not a novel concept, the establishment of hospital antimicrobial stewardship programs (ASPs) is strongly encouraged by the CDC and CMS. In response to the White House Forum on Antibiotic Stewardship and President Barack Obama’s September 2014 executive order, The Joint Commission recently announced its commitment to implementing changes and creating new standards, hoping to slow the emergence of antibiotic-resistant bacteria, detect resistant strains, preserve the efficacy of existing antibiotics, and prevent the spread of resistant infections.

Generally, hospital ASPs are multidisciplinary teams made up of a physician leader (most times an ID specialist), pharmacists and infection preventionists. Employing various modalities, these programs are ultimately designed to optimize and decrease antimicrobial utilization, prevent resistance and complications associated with anti-infective treatment, and reduce health care expenditures. While the programs have been beneficial, the CDC still estimates that 20% to 50% of all antibiotics prescribed in U.S. acute care hospitals are either unnecessary or inappropriate. The reason for the limited ceiling on ASP success is perhaps best explained by a commercial air travel analogy. When we arrive at an airport, we are greeted by airline agents, checked in by ticket agents, entrust our luggage to baggage handlers, and are greeted at the airplane’s entrance by attendants. Yet, upon entering the aircraft, most passengers look to the left to see who in the cockpit actually has their hands on the controls, and who is ultimately responsible for flying the plane. In other words, who is the pilot? Like the airline example, the clinician at the bedside (the pilot in this instance) who prescribes and controls the antibiotic has the greatest effect on the success or failure of achieving all of the intended goals or elements the ASP was created to accomplish. There is no question that the ID specialist is best prepared for this responsibility, for who better has the depth of knowledge, practical experience and clinical confidence critically needed to take these ASPs to the next level instead of just “going after the low-hanging fruit?”

It is a fact that there exists a limited number of ID specialists, and that the practice of medicine in community acute care hospitals (where more than 80% of hospital medicine occurs) poses somewhat different challenges than in the university academic centers. However, there is no uncertainty that anything short of this model is greatly restricted from its inception, and frankly cannot make any real, substantial difference in the full spectrum of the management of the serious issues related to antimicrobials, infection prevention and health care costs we now face. The time has long since passed for the creation of the ID specialist/hospitalist service. Supplied with the correct support staff charged with gathering information, required documentation, and coordinating care, the ID specialist would be unencumbered and allowed to focus on making the best clinical decision in every case.

We are all aware that in recent years the number of applicants and positions filled in ID fellowships has significantly diminished. Reasons suggested for the decline in internal medicine residency graduates’ interest in pursuing careers in ID include income restraints and the perception of an improved work-life balance afforded by a physician hospitalist position. However, the academic stimulation, opportunities to be involved in all aspects of medical care, and the importance of the ID physician has never been challenged. The ID leadership and specialty as a whole must now recognize this opportunity and tangibly demonstrate the enormous clinical and financial benefit achievable when we are the pilots — not just of the ASP but also of the entire spectrum of infectious disease diagnosis, treatment and prevention, in what has become the highest cost center in medicine: the acute care hospital. One of us (LMB) has utilized the ID physician/ASP model for 14 months, during which overall hospital antibiotic utilization was reduced by approximately 75%, and length of hospital stay by more than 1.5 days. In addition, the complication rate related to anti-infective therapies decreased significantly. The savings to the pharmacy and hospital has more than covered the cost of the physician’s time. To borrow a quote: “If not us, who? If not now, when?”

Disclosures: Bush and Kaye report no relevant financial disclosures.

A recently published governmental study estimated that 2 million persons become ill every year with antibiotic-resistant infections, and about 23,000 die. Antibiotics differ from many other pharmaceutical agents, not only by nature of their critical need, but also by their loss of efficacy over time, thereby requiring continual replacement. In essence, unlike other marketed medications, antibiotics are unique in that once these drugs are approved, their use is actually dissuaded in an effort to preserve their utility.

Larry M. Bush

Unfortunately, the increase in antimicrobial resistance is occurring simultaneously with the dramatic reduction in the number of new agents being presented to the FDA for approval. Fewer than 12 new agents have come into clinical practice over the past few decades, and almost no new classes of drugs have been developed to treat gram-negative bacillary infections for more than 40 years. This is no surprise, as the majority of new antimicrobial agent research and development rests with for-profit pharmaceutical companies. Due to the rising costs of new antibiotic development, declining return on investment, and inhibitory governmental regulations, these companies now lack incentive to pursue this line of business and have undertaken more profitable ventures. Further compounding this issue is the FDA’s noninferiority trial design requirement. Recognizing these roadblocks, the Infectious Diseases Society of America published a report in 2013 outlining specific solutions to the development and approval of antimicrobial drugs.

Donald Kaye

Having acknowledged the current state of affairs and the growing crisis of anti-infective chemotherapeutic agents, especially as it relates to the frightening expansion of multidrug-resistant organisms, the question at hand is how do we curtail and hopefully reverse this trend, which may force future physicians to practice medicine in a so-called “post-antibiotic era,” as did their predecessors in the “pre-antibiotic era.” Notwithstanding the knowledge that more than 75% of antimicrobial production is used for feeding animals, we are still left with a significant amount of antibiotic exposure by way of health care provider drug-prescribing practices. For example, in hospitalized patients alone, more than half are receiving antibiotics on any given day. For a host of reasons, there has been an ongoing unwillingness in the medical profession to accept measures for the restraint or control of indiscriminate prescribing of antibiotics. And therein lies the problem.

Various interventions designed to curtail the development of antibiotic resistance in this era of “bad bugs, no drugs” include both changes in agricultural government regulations and the creation of new health care policies. Although not a novel concept, the establishment of hospital antimicrobial stewardship programs (ASPs) is strongly encouraged by the CDC and CMS. In response to the White House Forum on Antibiotic Stewardship and President Barack Obama’s September 2014 executive order, The Joint Commission recently announced its commitment to implementing changes and creating new standards, hoping to slow the emergence of antibiotic-resistant bacteria, detect resistant strains, preserve the efficacy of existing antibiotics, and prevent the spread of resistant infections.

Generally, hospital ASPs are multidisciplinary teams made up of a physician leader (most times an ID specialist), pharmacists and infection preventionists. Employing various modalities, these programs are ultimately designed to optimize and decrease antimicrobial utilization, prevent resistance and complications associated with anti-infective treatment, and reduce health care expenditures. While the programs have been beneficial, the CDC still estimates that 20% to 50% of all antibiotics prescribed in U.S. acute care hospitals are either unnecessary or inappropriate. The reason for the limited ceiling on ASP success is perhaps best explained by a commercial air travel analogy. When we arrive at an airport, we are greeted by airline agents, checked in by ticket agents, entrust our luggage to baggage handlers, and are greeted at the airplane’s entrance by attendants. Yet, upon entering the aircraft, most passengers look to the left to see who in the cockpit actually has their hands on the controls, and who is ultimately responsible for flying the plane. In other words, who is the pilot? Like the airline example, the clinician at the bedside (the pilot in this instance) who prescribes and controls the antibiotic has the greatest effect on the success or failure of achieving all of the intended goals or elements the ASP was created to accomplish. There is no question that the ID specialist is best prepared for this responsibility, for who better has the depth of knowledge, practical experience and clinical confidence critically needed to take these ASPs to the next level instead of just “going after the low-hanging fruit?”

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It is a fact that there exists a limited number of ID specialists, and that the practice of medicine in community acute care hospitals (where more than 80% of hospital medicine occurs) poses somewhat different challenges than in the university academic centers. However, there is no uncertainty that anything short of this model is greatly restricted from its inception, and frankly cannot make any real, substantial difference in the full spectrum of the management of the serious issues related to antimicrobials, infection prevention and health care costs we now face. The time has long since passed for the creation of the ID specialist/hospitalist service. Supplied with the correct support staff charged with gathering information, required documentation, and coordinating care, the ID specialist would be unencumbered and allowed to focus on making the best clinical decision in every case.

We are all aware that in recent years the number of applicants and positions filled in ID fellowships has significantly diminished. Reasons suggested for the decline in internal medicine residency graduates’ interest in pursuing careers in ID include income restraints and the perception of an improved work-life balance afforded by a physician hospitalist position. However, the academic stimulation, opportunities to be involved in all aspects of medical care, and the importance of the ID physician has never been challenged. The ID leadership and specialty as a whole must now recognize this opportunity and tangibly demonstrate the enormous clinical and financial benefit achievable when we are the pilots — not just of the ASP but also of the entire spectrum of infectious disease diagnosis, treatment and prevention, in what has become the highest cost center in medicine: the acute care hospital. One of us (LMB) has utilized the ID physician/ASP model for 14 months, during which overall hospital antibiotic utilization was reduced by approximately 75%, and length of hospital stay by more than 1.5 days. In addition, the complication rate related to anti-infective therapies decreased significantly. The savings to the pharmacy and hospital has more than covered the cost of the physician’s time. To borrow a quote: “If not us, who? If not now, when?”

Disclosures: Bush and Kaye report no relevant financial disclosures.