For decades, our growing and reliable arsenal of antibiotic and antimicrobial drugs created a dangerously cavalier attitude toward the nature of microbial pathogens and the true threat to public health they represent. Numerous indicators tell us that the problem of drug resistance is rapidly expanding. Inappropriate or unnecessary prescribing of antibiotics is estimated to range between 20% and 50% of all prescriptions in US acute care hospitals1-7 and to be as high as 70% in US nursing homes.8 This antibiotic misuse is one of the key contributors to the spread of resistant and multidrug-resistant organisms. As a result, as many as 2 million individuals are infected with antibiotic-resistant organisms, resulting in approximately 23,000 deaths annually, according to the CDC.6
 
In response, a growing effort to reduce antibiotic overuse has emerged across Europe and the United States, with significant reported benefits, both clinical and financial. But what is the true cost to initiate these programs? What is the cost to hire required new personnel and to train existing staff? And what are the risks of stopping antibiotic treatment in a patient too quickly?
 
As has been well documented, hospitals that adopt antibiotic stewardship programs (ASPs) have demonstrated improved patient outcomes, decreased antibiotic resistance, decreased incidents of Clostridium difficile infections, and decreases in cost.9 The results of a University of Maryland study demonstrated that the implementation of an ASP saved $17 million over 8 years at one institution. Once the program was discontinued, antibiotic costs increased by more than $1 million in the first year (a 23% increase), with additional increases the following year.9
 
Well-managed ASPs can be economically justified by hospitals and—through the sustained efforts of dedicated resources—can assist in maintaining high-quality patient care and lower health care costs. This is accomplished through improvements in optimizing therapy selection, the avoidance of adverse drug events, better overall patient management, shorter hospital stays, and reduced readmission. These programs have consistently demonstrated a decrease in antibiotic use in excess of 20%, with significant annual savings.10 According to the combined Infectious Diseases Society of America (IDSA)/Society for Healthcare Epidemiology of America (SHEA) guidelines for developing ASPs,11  these programs have the potential to become financially self-supporting. Some programs resulted in 22% to 36% decreases in antimicrobial pharmacy use, which correlated to $200,000 to $900,000 in savings annually. Hospitals that have properly implemented ASPs often use these savings to staff and manage their stewardship efforts.
 
It is important to consider that generating antibiotic savings will not be sustainable in perpetuity; however, maintaining a lower-cost structure and being vigilant regarding appropriate utilization of antibiotics over the long run are possible.3
 
Antibiotic Stewardship Implementation and Electronic Health Record Integration
Numerous strategies can be implemented when an ASP is initiated, and most can be categorized as active or passive, based on their relevant impact on clinical outcomes and hospital and staff functioning. The selection of these strategies should be based on the scope of the ASP, the available facility resources, and the cost of the solutions.
 
One issue that should be thoroughly considered at the outset of establishing an ASP is its integration with the electronic health record (EHR) platform employed by your hospital or integrated delivery network. This is vitally important. Immediate access to relevant patient data is extremely important and a key driver for ASP success and accountability. Considering the cost of EHRs, it might be expected that ASP clinical decision support systems would be included, but they are not. 
 
With the $30 billion in tax incentives and punitive measures for failure to adopt a hospital-based EHR, they are now the norm, not the exception. However, these tools do not provide instant solutions for your antibiotic stewardship needs, nor are they without their problems. From 2008 to 2013, the percentage of hospitals that purchased and launched EHRs leapt from 13% to 70%. During the same period, the percentage of doctors’ offices with EHRs went from 17% to 48%. In a study of Boston hospitals that instituted EHRs, there was a significant number of problems, including adverse events directly connected to errors in the health record programs. In addition, a survey of users found that the number of physicians who were dissatisfied with their systems doubled from 2010 to 2012.12
 
Partners Healthcare revealed that the electronic prescribing clinical decision support (CDS) aspect of the large EHR systems has led to a steep increase in overalerting, alarm fatigue, and physicians overriding these warnings.13 By looking at 157,000 CDS alerts involving 2 million medication orders, the Partners Healthcare team found that more than 50% of these alerts were overridden. Of those, 53% were clinically appropriate alerts. Many health care systems question whether the enormous investment in EHRs has delivered, or will be able to deliver, the promised cost savings and improvements in outcomes.
 


Aside from the steep cost of EHRs, the ASP functions in large digital EHR systems are far from “plug and play.” Many of these tools were developed by individual hospitals, so their ASP functions are unique to their needs. Advanced functions, such as institutional antibiogram, preprogrammed “drug-bug” mismatch decision support, and improved days-of-therapy calculations, are not typically offered14.15
 
Cost Versus Benefits
The CMS Value-Based Purchasing Program (VBP) and the Hospital-Acquired Condition Reduction Program (HAC) are 2 relatively new incentive programs that contribute to a hospital’s reimbursement scorecards. These efforts align with the overall movement to end the fee-for-service model and replace it with one that prioritizes quality, outcomes, and patient satisfaction. When it comes to antibiotic stewardship, the VBP and the HAC can both reward or penalize.
 
The VBP rewards hospitals for improvements in care quality, and several processes of care measures incorporated in the VBP scores relate to antimicrobial stewardship including The Joint Commission Core Measures for pneumonia (PN-3b, PN-6) and surgical prophylaxis (SCIP-Inf-1 and SCIPInf-4). Infection-related outcome measures incorporated into the VBP include central line–associated bloodstream infection and pneumonia 30-day mortality rate (MORT-30-PN). Readmissions of patients with pneumonia within 30 days following discharge can also dramatically impact CMS payments to hospitals. According to an analysis by Modern Healthcare,15  reimbursement bonuses should surpass penalties under the VBP.
 
CMS initiated the HAC to encourage hospitals to reduce errors and nosocomial infections. Hospital performance under the HAC is determined based on a hospital’s total HAC score, which can range from 1 to 10. The higher a hospital’s total HAC score, the worse the hospital performed under the HAC. The HAC and the VBP will inevitably reward and penalize hospitals for antibiotic stewardship or the lack of it. And these bonuses or lost dollars can be quite significant.
 
An effective ASP is a highly complex undertaking, requiring the integration and ongoing communication of multiple clinical departments. Small to midsize hospitals often do not have access to infectious disease physicians, so pharmacists must be trained to fill this vital role. The IDSA/SHEA guidelines for developing an institutional program to enhance antimicrobial stewardship detail the foundational requirements of an effective ASP. However, no 2 hospitals are the same, so there is no one-size-fits-all solution.
 
Pharmacists have a number of options for obtaining infectious disease experience and training, including residencies and fellowships, work experience, and third-party certification programs in infectious disease. Many pharmacists have an interest in infectious disease specialization, but they typically cannot sidetrack their work schedule to complete the required training, specialty residency programs, or fellowships. These programs generally take 1 to 2 years to complete and add a significant financial burden to pharmacists. However, pharmacists have alternative options that meet ASP guidelines established by IDSA, SHEA, and other organizations. In terms of formal acceptable infectious disease training, the following options are available to working pharmacists and those who have recently graduated from pharmacy school:
  • The Added Qualifications in Infectious Diseases certification is available for pharmacists who are already board-certified specialists in pharmacotherapy (BCPS). Requirements for a separate certification through BCPS programs are detailed at bcsp.org.
  • The Society of Infectious Disease Pharmacists (sidp.org) offers an infectious disease training certification program.
  • Making a Difference in Infectious Diseases (mad-id.org) provides basic and advanced infectious disease training certification programs for pharmacists.
The necessary investments are modest for most of these certifications, ranging from $750 to $1000, depending on which organization is selected and the extent of the required project for certification completion. The option from the Board of Specialty Pharmacy is more costly because it requires a BCPS certificate and an additional infectious disease certificate, which costs extra.
 
Hospitals that implement effective ASPs see significant decreases in the emergence of resistant organisms. In their 2002 article, Cosgrove et al16 suggested that in addition to reducing the cost of antibiotics, ASPs generate savings by reducing the need for critical care for those with serious drug-resistant organisms. This article details cephalosporin-resistant Enterobacter infections, which were associated with increases in the need for critical care and in length of stay, which added an average of $29,379.60 per case.
 
There is a right way and a wrong way to discontinue intravenous antibiotics. All decisions by licensed health care providers are trade-offs in which risks are weighed. Usually, the less risky option is chosen, as best as it can be quantified in real time using patient data and available infectious disease diagnostic information. Ultimately, stewardship is about striking a delicate balance between the benefit of therapy to a single patient versus the potential costs to future patients. Reductions in pharmacy costs and hospital length of stay should not be the only measures of success. Reduced length of stay quickly becomes meaningless if readmissions start to climb. Premature discontinuation of antibiotics can be disastrous to a patient’s health and can increase the risk of resistance and the cost of care.17
 
Conclusion
The stewardship tactics detailed in this article have translated into reduced hospital-acquired infections, shorter lengths of stay, fewer readmissions, and greater rates of reimbursement. The President’s Council of Advisors on Science and Technology 2014 recommended that a regulatory requirement for antibiotic stewardship be in place by the end of 2017. ASPs will likely soon become mandatory for all US hospitals based on the IDSA/SHEA model. Although the challenges associated with ASPs are great, the potential rewards, such as improved patient outcomes and sustainable cost reductions, can be significant. And the investment for launching a robust ASP pales compared with the potential savings, the penalties that can be averted, and, most important, the lives that can be saved.
 
The undeniable risks associated with discontinuing antibiotics have high costs in terms of lives and dollars. Therefore, the essential first step toward responsibly implementing an ASP is to follow the guidelines, requirements and best practices outlined in the IDSA/SHEA combined guidance as well as other guidelines.
 
This article is published in collaboration with the Directions in Pharmacy CE Conference program.
 
Dr. Kevin Rivers’ passion is assisting acute care hospitals and IVD/medical device companies in building clinical programs which impact patient care. He has had multiple business successes across the U.S. and Asia, with significant experience in Western Europe.

Herb Steward is a commercial operations consultant with repeated business success across the Americas, Europe, the Middle East and Africa. He has more than 25 years of extensive hands-on experience in business development and product commercialization. He has grown companies successfully in excess of $400 million USD.


References
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  2. Antibiotic resistance threats in the United States, 2013. CDC website. cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed May 31, 2016.
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