Developing an Antimicrobial Stewardship Program in the Hospital Setting

Valeria Fabre

Sara E. Cosgrove

Emily S. Spivak

BACKGROUND

Over the last two decades, the need for antibiotic stewardship (AS) has been recognized across healthcare and by governments due to an alarming increase and spread of antibiotic-resistant infections.¹ The health burden of antibiotic-resistant infections in the European Union has been estimated in one study to be similar of that of human immunodeficiency virus, tuberculosis, and influenza combined.² Another study suggests that multidrug-resistant organism (MDRO) infections are the third most common cause of death in the United States.³ Resistant infections have been associated with longer hospital stay, increased mortality, and increased healthcare costs.⁴^,⁵ The primary purpose of AS is to optimize clinical outcomes while minimizing unintended consequences of antibiotic use, including toxicity, the selection of pathogenic organisms such as Clostridioides difficile, and the emergence of resistance. Implementation of antibiotic stewardship programs (ASPs) in healthcare has been associated with reductions in patient mortality⁶; fewer side effects; fewer infections with resistant bacteria such as multidrug-resistant Gram-negative organisms, methicillin-resistant Staphylococcus aureus (MRSA), and C difficile⁷^,⁸^,⁹; fewer readmissions¹⁰; shorter length of hospital stay; and cost savings.¹¹ A national outpatient ASP in England led to an 8% and 19% reduction in overall and broad-spectrum antibiotic use, respectively.¹² In the United States, widespread ASP implementation has been estimated to lead to a median reduction in antibiotic use of 16%.¹³ In this chapter, we will provide an overview of key aspects related to developing and running an ASP.

AS PROGRAM DEVELOPMENT

Guidance on how to structure and the steps to implement an ASP have been outlined in existing Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines¹⁴ as well as in the Centers for Disease Control and Prevention (CDC) Core Elements of AS.¹⁵ The Core Elements are also the basis for current hospital accreditation requirements for ASPs from The Joint Commission (TJC) and other accrediting organizations,¹⁶^,¹⁷ as well as the U.S. Centers for Medicare and Medicaid Services (CMS)’ Condition of Participation requiring all acute care hospitals, including critical access hospitals, to have an ASP.¹⁸ The CDC Core Elements have been recently updated¹⁵ and are summarized in Table 44-1. These seven elements are required for an effective ASP and will be addressed below and in Chapter 45, Interventions to Optimize Antibiotic Use, that specifically focuses on ASP interventions.

Program Building: Leadership Support

Support of the ASP from the hospital’s senior leadership is critical for the maintenance and success of the program. While senior administrators are not expected to manage the ASP or perform daily activities, they can support the
overall mission of the ASP, promote that mission as that of the entire institution, and provide financial support for the ASP.

TABLE 44-1 CDC Core Elements of AS

1. Hospital Leadership Commitment: Dedicating necessary human, financial, and information technology resources

2. Accountability: Appointing a leader/coleaders responsible for program outcomes. If a nonphysician is the leader, the hospital should designate a physician to support the nonphysician leader

3. Pharmacy Expertise: Appointing a single pharmacist leader responsible for working to improve antibiotic use

4. Action: Implementing at least one recommended action

5. Tracking: Monitoring antibiotic prescribing and resistance patterns

6. Reporting: Regular reporting information on antibiotic use and resistance to doctors, nurses, and relevant staff

7. Education: Educating clinicians about resistance and optimal prescribing

Inclusion of new standards on AS by hospital accreditation agencies and CMS has facilitated funds and resources for ASPs in some institutions. However, many ASPs are not adequately staffed¹⁸^,¹⁹ and the ASP leader should be prepared to craft business plans to engage hospital leadership to provide funds to sustain or expand AS activities (see Hospital Administration section below for further discussion on this topic). Recent studies have reported minimum required staffing for effective ASPs.²⁰^,²¹ Recommended minimal staffing levels based on hospital bed size include the following: for 100-300 beds, at least 1 pharmacist full-time equivalents (FTE); for 100-300 beds, at least 1 pharmacist FTE and 0.4 physician FTE; for 301-500 beds 1.2 pharmacist FTE and 0.4 physician FTE; for 501-1000 beds, 2 pharmacist FTE and 0.6 physician FTE; and for >1000 beds, 3 pharmacist FTEs and 1 physician FTE. In addition to physician and pharmacist staffing of the ASP, the ASP leader must negotiate support for experts in information technology (IT) and data analysis to operationalize ASP interventions through the electronic health records (EHR) system and obtain and analyze antibiotic use and resistance as discussed in the IT section below.

Hospital leadership can ensure the ASP has sufficient authority, set expectations, develop accountability models, create financial incentives for units with good antibiotic use performance, and facilitate connections between the efforts of the ASP and other quality and safety efforts such as surgical prophylaxis and surgical site infection prevention, sepsis management, reduction of unnecessary diagnostic testing, reduction in testing, and treatment of asymptomatic bacteriuria (ASB).

Whenever possible, we recommend the ASP to report directly to senior hospital leadership. Specifically, support from the chief medical officer (CMO) and director of pharmacy is imperative. Careful attention should be given to reporting structures for the ASP as a whole and the physician and pharmacist coleads individually. Some programs and personnel report entirely to the Quality Department. Other programs report to the Quality Department and Pharmacy and Therapeutics Committee for program outcomes; however, the physician colead reports to the CMO and pharmacy colead to the director of pharmacy. No standard exists for ASP and personnel reporting structure; rather, individual programs need to develop reporting structures that best position them to garner needed resources and align goals to allow the ASP to accomplish the hospital’s goals for improving antibiotic use.

Program Building: The Core Team

The ASP core team is responsible for developing, implementing, and managing the ASP. Ideally, the core team includes a physician and a pharmacist.²² Physicians and pharmacists have unique skill sets and expertise that make their contributions to the ASP complementary. The ASP physician and pharmacist should work together as coleaders to set a strategic annual plan (see below for further discussion in developing an annual plan), develop guidelines for prescribing, determine and execute AS interventions including targeted quality improvement interventions, guide formulary decisions, and evaluate and disseminate antibiotic use data. Responsibilities of the ASP leader or coleaders are summarized in Table 44-2.

Whenever possible, it is recommended that their offices be located in the same area to facilitate daily interactions. If the physician leader does not work full time at the hospital, delineating clear responsibilities and expectations for the coleaders is essential for the good functioning of the ASP.

The ASP Physician It is advisable that the ASP physician leader be an infectious diseases (ID) physician, as ID physicians by virtue of their training have comprehensive knowledge of both antibiotics and management of complex
infectious diseases.¹⁴ The ASP physician is responsible for communicating the goals of the ASP and approaches and needs to achieve those goals to senior leadership and prescribers. Physicians perform the majority of antibiotic prescribing in the hospital, and they are more likely to accept the concept of AS and AS recommendations if they know that a physician colleague is providing leadership and guidance in the ASP. The physician leader has the standing to discuss inappropriate prescribing habits to senior physicians. Also, physicians have experience being the primary individual responsible for making decisions about the diagnosis, management, and treatment of patients and are able to apply this perspective to AS recommendations, particularly those involving patients with complicated diagnostic and management issues. On-site access to an ID physician is lacking in ˜50% of US hospitals.¹⁹ Options to consider in this case include contracting for remote access to an ID physician (“telemedicine”), joining regional or state AS collaborations that provide AS training and peer-to-peer support, or appointing a non-ID-trained physician with a general understanding of infectious diseases (eg, internist, hospitalist, critical care physician) and with an interest in AS. In one study, telehealth implementation in <300-bed size community hospitals resulted in 24% decrease in broad-spectrum antibiotic prescriptions while increasing ID consultations by 40%.23 Telehealth platforms can be used to provide educational opportunities on AS principles, share tools and best practices, provide case consultation, and allow the review of antibiotic use with feedback.²⁴ Before implementing any remote electronic services, it is recommended to consult with a telemedicine expert or an ASP that has used telemedicine to ensure that reimbursement and regulations regarding licensure and liability are appropriately addressed by the ASP.²⁴ If the individual responsible for the ASP is not ID trained, this person should seek AS training offered at national ID or hospital epidemiology conferences or online.²⁵^,²⁶^,²⁷

TABLE 44-2 Examples of Responsibilities of the ASP Leader/Coleaders

ASP leader

Determines ASP goals and maintains a long-range perspective

Ensures support from physicians to implement practice changes

Ensures support from Pharmacy and coordinates activities between Pharmacy and ASP team

Presents data to hospital administration and hospital leadership

Participation/oversight of daily interventions

Trains other healthcare providers in principles of ASP

Makes formulary decisions for new agents and reviews for redundant agents

Develops therapeutic guidelines

Develops strategies to improve daily antimicrobials use

Identifies quality improvement interventions

Analyzes and disseminates data

Performs drug review to inform antibiotic restriction policies

While pharmacists can complete most interventions, the physician should engage directly with treating prescribers for challenging or controversial cases. Physician leadership and daily involvement is particularly important if the ASP pharmacist does not have specific training in ID. Additional activities that the ASP physician may perform include in-person rounds in selected units (“handshake stewardship”), assisting with diagnostic dilemmas, feedback recommendations to providers, develop therapeutic guidelines, develop restriction policies, and engage unit leadership in safer antibiotic use.

Given that daily program responsibilities may be shared among other staff (eg, ID fellows, unit pharmacists), the ASP leader must ensure adequate scheduling and processes to ensure these activities are aligned with ASP’s objectives.

The ASP Pharmacist The ASP pharmacist provides expertise in pharmacotherapeutics, including antibiotic choice and dosing, drug interactions, and adverse events and duration of treatment. Effective ASPs in large academic centers have a physician and pharmacist coleaders. If the ASP is led by a nonphysician, it is important that the hospital designates a physician to support the ASP nonphysician leader for the reasons described above.

It is advisable the ASP pharmacist be trained in ID or AS for the same reasons previously noted for the ASP physician. The Society of Infectious Diseases Pharmacists (SIDP) and American College of Clinical Pharmacy (ACCP) recommend a future ID-trained pharmacist to attain a PGY1 residency and a PGY2 residency in ID; however, no recommendations were made to establish training requirements for pharmacists with extensive on-the-job training in ID.²⁸ Certificate ID pharmacy programs are available through SIDP and Making-a-Difference in Infectious Diseases Pharmacotherapy (MAD-ID) program or through courses offered at national ID or hospital epidemiology conferences.²⁵^,²⁶^,²⁷^,²⁹ Resources can also be found online through the Agency for Healthcare Research and Quality²⁷ or the CDC.³⁰ ASP pharmacists not trained in ID must be cognizant of the areas of uncertainty within ID such as limitations of microbiologic testing, lack of robust data to support certain practices, and clinical scenarios that are outside of usual AS guidelines. Similarly, ASP pharmacists not trained in ID or AS must feel comfortable advising physicians, be prepared to provide a basis for a given antibiotic recommendation, and be able to recognize concerns the primary team may have about the patient. Shadowing an ID physician may be an opportunity for the pharmacist to gain a better understanding of bedside patient care. In one study, 60 minutes twice- or three-times-a-week review of cases by an ID physician with the local pharmacist through telehealth with results conveyed by the pharmacist resulted in significant reductions in broad-spectrum antibiotic use.²³

The ASP pharmacist will play a critical role in engaging and training other pharmacy staff in AS principles and antibiotic use to expand the pharmacy stewardship workforce across the hospital. The daily activities of an ASP are time intensive; hence, it is recommended that activities are scheduled according to resources.

Program Building: The Extended ASP Team and Key ASP Partners

ASP Committee All ASPs should convene an AS Committee that meets at least quarterly. The AS Committee provides a forum to discuss a variety of AS issues with institutional stakeholders. Members of the AS Committee should have an interest in AS and patient safety and should be encouraged to bring concerns related to antibiotic use that impact patient care to the AS Committee. This committee is separate from Pharmacy and Therapeutics (P&T) Committee and its Antibiotic Subcommittee. ASPs should participate in these committees when formulary issues regarding anti-infectives are discussed and often report program outcomes to these committees. However, these committees predominantly oversee policies and guidelines related to formulary management and are not always well positioned to address all issues regarding antibiotic use, particularly in larger hospitals. The AS Committee members should also help disseminate information about ASP activities such as new recommendation updates and new diagnostic tests back to frontline providers. Suggested members and responsibilities of the AS Committee can be found in Table 44-3. Medical staff to be included are representatives from hospital medicine, critical care, ID, surgery, obstetrics, and pediatrics as well as housestaff and fellows when present in the institution. The ASP leader should clarify what institutional committee the AS Committee reports to, and minutes should be taken and disseminated.

TABLE 44-3 Suggested AS Committee Members and Committee Responsibilities

Members

Senior executive
Pharmacy department
Medical staff
Infectious diseases physicians
Medicine/surgery resident
Information technology
Microbiology laboratory
Infection prevention/hospital epidemiology
Department of nursing
Regulatory affairs
Department of quality improvement
Department of patient safety
Patient representative

Responsibilities

Develop annual plan
Review antibiotic use data
Review new therapeutic guidelines
Review implementation of QI projects
Review results of QI projects
Know susceptibility trends for major pathogens
Assess opportunities for improvement

Department of Pharmacy The department of pharmacy is a critical ASP partner as it coordinates antibiotic dispensing and plays a large role in formulary decisions and management of antibiotic shortages. Non-AS pharmacists impact AS in several ways including ensuring appropriate approval is in place before releasing a restricted antibiotic, alerting the prescriber of antibiotic allergies or receipt of recent β-lactams in a patient with a penicillin allergy label, alerting the prescriber of unnecessary duplicative anaerobic therapy, operationalizing intravenous (IV) to oral (PO) switch protocols, therapeutic monitoring and dosing of vancomycin and aminoglycosides, and alerting the ASP of potential cases for antibiotic review. Thus, the ASP should provide regular education and support to non-AS pharmacists to ensure their engagement. In larger settings, ASPs have developed training programs for non-AS pharmacists to allow them to perform AS interventions that have resulted in improved clinical management of S aureus bacteremia,³¹ improved antibiotic use in the intensive care unit,³² and increase in β-lactam use through detailed assessment of antibiotic allergies.³³

TABLE 44-4 Activities by Which the Microbiology Laboratory Impacts Antibiotic Prescribing

Microbiologic diagnosis

Provides guidance to enhance yield of cultures (eg, guidance on preferred tissue, specimen volume)

Assists frontline providers in determining best diagnostic modality for certain conditions

Alerts the treating physician of positive cultures from sterile site and unusual or highly resistant organisms

Creates protocols to avoid inappropriate cultures (eg, rejects tips of vascular catheters for culture without paired blood culture)

Assists in guidelines and policy development regarding microbiologic testing

Implements new diagnostic testing methods

Antimicrobial usage

Performs susceptibility testing and determines what antibiotics are reported, including cascade reporting

Performs rapid diagnostic tests and identifies resistance genes

Performs diagnostic stewardship (eg, rejects formed stools for C difficile testing)

Reports MICs for dosing based on pharmacokinetic targets (eg, dose-dependent MICs)

Develops antibiogram

Validates susceptibility testing for new drugs that are intended to be added to formulary list

The ASP should work closely with the pharmacy department and the P&T Committee on antibiotic formulary decisions. Formulary stewardship is a key intervention to facilitate antibiotic choices be more aligned with AS principles and goals by simply limiting which antibiotics are available to prescribers at a given institution.³⁴ Formulary decisions should take into consideration antibiotic cost, frequency of agent use, and available alternative therapies. Once the drug is on formulary, the ASP and P&T will need to decide as to whether the agent will be restricted (ie, require prior authorization) or not.

The pharmacy department must be proactive about developing and implementing a process for informing prescribers of shortages and ensuring the safe and effective use of alternative therapies. The ASP must have a process in place to learn from pharmacy of anticipated or existing shortages to adjust antibiotic recommendations and minimize effects on patient care. Further discussion about drug shortage strategic planning can be found in the guidelines on managing drug product shortages by the American Society of Health-System Pharmacists.³⁵ It is advisable that at least one non-ASP pharmacist participates of the AS committee to enhance collaboration and communication between ASP and the department of pharmacy.

Microbiology Laboratory The microbiology laboratory is a vital partner of the ASP as it provides patient-specific culture and susceptibility data that will inform antibiotic management.³⁶

There are many activities by which the clinical microbiology laboratory can contribute to AS efforts; some examples are provided in Table 44-4. Knowing what the current issues related to antibiotic use and/or detection of infections are as well as the ASP’s objectives will help the clinical microbiologist tailor what the laboratory can offer to help accomplish these objectives. It is essential that the
clinical microbiologist participates in the AS Committee and meets periodically and as needed with ASP (and Infection Prevention department whenever possible) to enhance ASP activities.

Even though all microbiology activities that may impact antibiotic management are of interest to the ASP, three of these activities are highlighted here due to their impact on antibiotic decisions:

Antibiograms Cumulative antibiotic susceptibility reports, also known as antibiograms, may inform local guidelines for empiric treatment of common infectious syndromes (see Guidelines section below for a discussion of the role of antibiogram in treatment guidelines), help prescribers select effective therapy while cultures are pending, inform healthcare providers about local resistance, and provide a rationale for antibiotic formulary selection. Recommendations for antibiograms are provided by Clinical and Laboratory Standards Institute (CLSI)³⁷; however, it is not infrequent that hospitals’ antibiograms are not compliant with CLSI recommendations,³⁸ negatively affecting the quality of the report and creating an opportunity for suboptimal antibiotic use. The ASP must work closely with the clinical microbiologist to determine:

If stratified antibiograms (eg, by patient location at time of culture [eg, outpatient/emergency department, inpatient non-intensive care unit, or intensive care unit], patient type or specimen type [eg, blood, urine, wound, cerebral spinal fluid, pulmonary]) can be developed taking into consideration volume of isolates and patient populations at a given hospital (eg, patients with certain chronic medical conditions that lead to frequent antibiotic exposure may not be well represented in a hospital-wide antibiogram and may need a customized antibiogram)

Frequency of updates taking into consideration CLSI guidelines

How the antibiogram will be disseminated to frontline staff

Rapid diagnostic tests Rapid diagnostic technology presents unique opportunities and challenges to ASP. Decreasing the time to culture results has been proposed as a cost-effective strategy to optimize patient care and antibiotic use; however, studies have shown that rapid diagnostic tests (RDTs) are only cost-effective³⁹ and help antibiotic optimization⁴⁰^,⁴¹ when they are implemented in conjunction with ASP. Therefore, it is imperative that the clinical microbiologist works with the ASP before implementation of RDTs to determine:

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