Championing Patient Safety: The Seven Key Elements of a Hospital Antibiotic Stewardship Program

Introduction

The discovery of antibiotics revolutionized healthcare, transforming previously deadly infections into manageable conditions and paving the way for advanced medical procedures like chemotherapy and organ transplantation. Rapid antibiotic administration is often critical in treating infections, significantly reducing illness and saving lives, particularly in cases of sepsis¹. However, studies reveal that approximately 30% of antibiotics prescribed in US acute care hospitals are either unnecessary or not optimally chosen²³.

Like all medications, antibiotics carry the risk of significant adverse effects, affecting about 20% of hospitalized patients who receive them⁴. Unnecessary antibiotic exposure puts patients at risk of these harmful events without providing any benefit. Furthermore, antibiotic misuse is a major driver of antibiotic resistance, a critical public health threat⁵. This misuse not only harms those directly exposed but also indirectly impacts others through the spread of resistant bacteria and Clostridioides difficile (C. difficile) infections⁶.

Optimizing antibiotic use is paramount for effectively treating infections, safeguarding patients from the harms of unnecessary antibiotics, and combating the growing threat of antibiotic resistance. Hospital Antibiotic Stewardship Programs (ASPs) are essential tools for clinicians to enhance patient outcomes and minimize harm by improving antibiotic prescribing practices²⁷. Effective hospital ASPs can increase infection cure rates while simultaneously reducing⁷⁸⁹:

• Treatment failures
• C. difficile infections
• Adverse drug events
• Antibiotic resistance
• Hospital costs and lengths of stay

Recognizing the urgency, the Centers for Disease Control and Prevention (CDC) issued a call in 2014 for all US hospitals to implement antibiotic stewardship programs. To support this initiative, the CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements), a framework outlining the essential structural and procedural components of successful stewardship programs. These Core Elements serve as a critical guide for hospitals aiming to establish robust Advocate Health Care Seven Key Elements Of Compliance Program in antibiotic use.

In 2015, the US National Action Plan for Combating Antibiotic-Resistant Bacteria set a national goal to implement these Core Elements in all hospitals receiving federal funding¹⁰, underscoring the national commitment to antibiotic stewardship as a vital aspect of healthcare compliance and patient safety.

Understanding the Core Elements: A Framework for Healthcare Compliance

To further facilitate the adoption and implementation of the Core Elements, the CDC has actively provided ongoing support and resources. It’s important to dispel any misconceptions that antibiotic stewardship might impede efforts to improve the management of sepsis¹¹. Instead, ASPs are designed to optimize antibiotic use, leading to improved patient outcomes without compromising care for critical conditions like sepsis.

Partners nationwide are leveraging the Core Elements to guide their antibiotic stewardship initiatives within hospital settings. These elements have become the cornerstone for antibiotic stewardship accreditation standards set by The Joint Commission and DNV-GL¹². Furthermore, the 2019 hospital Conditions of Participation from the Centers for Medicare & Medicaid Services (CMS) established a federal regulation for hospital antibiotic stewardship programs, directly referencing the Core Elements as the benchmark for compliance¹³. Significant progress has been made in US hospitals adopting these principles, with 85% of acute care hospitals reporting implementation of all seven Core Elements in 2018, a substantial increase from just 41% in 2014¹⁴.

The field of antibiotic stewardship has evolved significantly since 2014, marked by a growing body of evidence and the publication of an implementation guideline by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America¹⁵. This underscores the dynamic nature of antibiotic stewardship and the continuous refinement of best practices.

In 2019, the CDC updated the Core Elements for Hospital Antibiotic Stewardship Programs, incorporating five years of practical experience and the latest evidence in the field. This updated document serves as a guide for hospitals of all sizes, recognizing that there is no one-size-fits-all approach to optimizing antibiotic prescribing. Flexibility is key, given the complexities of medical decision-making and the diverse nature of US hospitals. The Core Elements offer an adaptable framework that hospitals can utilize to direct their efforts in improving antibiotic prescribing, supported by an assessment tool to identify areas for improvement. This framework essentially embodies the advocate health care seven key elements of compliance program for antibiotic stewardship in hospitals.

Summary of Key Updates to the Core Elements

The 2019 update to the hospital Core Elements reflects lessons learned and new evidence, focusing on enhancing the practical application and impact of stewardship programs. Major updates include refinements to each of the seven core elements:

1. Hospital Leadership Commitment

Dedicate necessary human, financial, and information technology resources.

• The 2019 update provides more specific examples of leadership commitment, categorized as “priority” and “other”.
• Priority examples emphasize the critical need for dedicated time and resources for ASP leadership to effectively manage programs and ensure regular reporting of activities, resource needs, and outcomes to senior executives and the hospital board.

2. Accountability

Appoint a leader or co-leaders, such as a physician and pharmacist, responsible for program management and outcomes.

• The update highlights the effectiveness of physician and pharmacy co-leadership, a model reported by 59% of hospitals in the 2019 NHSN Annual Hospital Survey, recognizing the synergistic expertise of both professions.

3. Pharmacy Expertise (formerly “Drug Expertise”)

Appoint a pharmacist, ideally as the co-leader of the stewardship program, to lead implementation efforts to improve antibiotic use.

• Renamed to “Pharmacy Expertise” to emphasize the crucial role of pharmacists in leading the practical implementation of antibiotic stewardship initiatives.

4. Action

Implement interventions, such as prospective audit and feedback or preauthorization, to improve antibiotic use.

• The 2019 update expands on intervention examples, categorizing them into “priority” and “other” interventions. “Other” interventions are further classified as infection-based, provider-based, pharmacy-based, microbiology-based, and nursing-based.
• Priority interventions include prospective audit and feedback, preauthorization, and facility-specific treatment recommendations, all evidence-backed strategies for improving antibiotic utilization. These are considered core components of any effective stewardship program.
• The update stresses focusing actions on the most common indications for hospital antibiotic use: lower respiratory tract infections (e.g., community-acquired pneumonia), urinary tract infections, and skin and soft tissue infections.
• The antibiotic timeout is repositioned as a supplemental intervention, not a replacement for prospective audit and feedback, clarifying its role within a comprehensive ASP.
• A new category of nursing-based actions is added, acknowledging the significant contribution nurses can make to hospital antibiotic stewardship.

5. Tracking

Monitor antibiotic prescribing, impact of interventions, and other important outcomes like C. difficile infection and resistance patterns.

• Hospitals are encouraged to electronically submit antibiotic use data to the National Healthcare Safety Network (NHSN) Antimicrobial Use (AU) Option for robust monitoring and benchmarking of inpatient antibiotic use.
• Antibiotic stewardship process measures are expanded and stratified into “priority” and “other”, offering a more detailed approach to performance assessment.
• Priority process measures focus on evaluating the impact of key interventions, including prospective audit and feedback, preauthorization, and adherence to facility-specific treatment recommendations.

6. Reporting

Regularly report information on antibiotic use and resistance to prescribers, pharmacists, nurses, and hospital leadership.

• The 2019 update emphasizes the value of provider-level data reporting, although acknowledges the need for more research in the hospital setting to fully understand its impact on antibiotic use improvement.

7. Education

Educate prescribers, pharmacists, and nurses about adverse reactions from antibiotics, antibiotic resistance, and optimal prescribing.

• The update highlights case-based education through prospective audit and feedback and preauthorization as highly effective methods for educating on antibiotic use, especially when delivered in person (handshake stewardship).
• The update also suggests actively involving nurses in patient education efforts, recognizing their crucial role in patient communication and understanding.

Deep Dive into the Seven Core Elements

Each of the seven Core Elements is crucial for establishing and maintaining an effective hospital antibiotic stewardship program. These elements, when implemented comprehensively, form a robust framework for advocate health care seven key elements of compliance program, ensuring responsible antibiotic use and improved patient safety.

1. Hospital Leadership Commitment: Setting the Stage for Success

Strong support from hospital senior leadership, particularly the chief medical officer, chief nursing officer, and director of pharmacy, is fundamental to the success of any antibiotic stewardship program. Lack of resources is consistently cited as a major barrier to ASP effectiveness. Hospital leadership plays a vital role in securing the necessary resources for the program to achieve its objectives.

Interestingly, while the primary goal of stewardship programs is to improve patient care, numerous studies demonstrate that they are often cost-neutral or even cost-saving, primarily through reductions in antibiotic expenditures and indirect costs⁷¹⁶.

Priority Examples of Leadership Commitment

• Allocating time for stewardship program leader(s) to manage the program and conduct daily stewardship interventions.
• Providing adequate resources, including dedicated staffing, to ensure effective program operation. Staffing recommendations for hospital ASPs are available from sources like the Veteran’s Administration and surveys conducted in 2018¹⁷¹⁸.
• Holding regular meetings with ASP leaders to assess resource needs and align program goals with hospital-wide objectives for improving antibiotic use.
• Appointing a senior executive leader as a dedicated point of contact or “champion” for the ASP, ensuring program access to resources and sustained support.
• Regularly reporting stewardship activities and outcomes (including success stories) to senior leadership and the hospital board, integrating stewardship metrics into hospital quality dashboards.

Other Examples of Leadership Commitment

• Integrating ASP activities into broader quality improvement and patient safety initiatives, such as sepsis management and diagnostic stewardship.
• Establishing clear expectations for program leaders regarding responsibilities and desired outcomes.
• Issuing formal statements of support for antibiotic stewardship efforts and monitoring antibiotic use.
• Incorporating stewardship-related duties into job descriptions and performance reviews for program leaders and key support staff.
• Supporting training and education for program leaders (e.g., attendance at stewardship training courses and conferences) and hospital staff.
• Facilitating enrollment in and reporting to the National Healthcare Safety Network (NHSN) Antimicrobial Use and Resistance (AUR) Module¹⁹, including providing necessary information technology support.
• Supporting participation in local, state, and national antibiotic stewardship quality improvement collaboratives.
• Ensuring staff from key support departments have sufficient time to contribute to stewardship activities.

Key Support Departments

Hospital leadership can foster collaboration and awareness of stewardship efforts across various hospital departments. Strong support from the following groups is crucial for program success:

• Clinicians: Full engagement and support from all clinicians are vital. Hospitalists are particularly important due to their significant role in antibiotic prescribing and quality improvement initiatives²⁰²¹.
• Department or program heads: Support from clinical department heads and the director of pharmacy is essential for embedding stewardship activities into daily workflows.
• Pharmacy and Therapeutics Committee: This committee plays a key role in developing and implementing policies to improve antibiotic use, such as incorporating stewardship into order sets and clinical pathways. Some hospitals establish multidisciplinary stewardship subcommittees within the Pharmacy and Therapeutics Committee.
• Infection preventionists and hospital epidemiologists: They contribute by educating staff and analyzing/reporting data on antibiotic resistance and C. difficile infection trends²²²³. They also support NHSN AUR Module reporting.
• Quality improvement, patient safety, and regulatory staff: They advocate for resources and integrate stewardship interventions into broader quality improvement efforts, especially sepsis management, and support implementation and outcome assessments.
• Microbiology laboratory staff:
  • Guide appropriate test utilization and result interpretation for “diagnostic stewardship”²⁴.
  • Optimize empiric antibiotic prescribing by creating and interpreting facility-specific cumulative antibiotic resistance reports (antibiograms).
  • Advise on the implementation of rapid diagnostic tests and updated antibacterial susceptibility test interpretive criteria (antibiotic breakpoints).
  • Collaborate on guidance for clinicians regarding changes in laboratory testing practices²⁵.
  • Hospitals using external microbiology services should ensure data accessibility for stewardship efforts.
• Information technology staff: They are critical for integrating stewardship protocols into existing workflows by:
  • Embedding relevant information and protocols at the point of care (order sets, guidelines).
  • Implementing clinical decision support for antibiotic use and prompts for antibiotic reviews.
  • Facilitating and maintaining NHSN AUR reporting.
• Nurses: Nurses play an increasingly recognized role in hospital stewardship efforts²⁶²⁷²⁸, particularly in:
  • Optimizing testing, or diagnostic stewardship, by informing decisions about the necessity of urine cultures.
  • Ensuring proper culture collection before antibiotic initiation.
  • Prompting discussions about antibiotic treatment, indication, and duration.
  • Improving penicillin allergy assessments.

2. Accountability: Defining Leadership and Responsibility

A successful antibiotic stewardship program must have clearly designated leader(s) accountable for program management and outcomes. A co-leadership model is frequently effective; the 2019 NHSN survey indicated that 59% of US hospitals have stewardship programs co-led by a physician and pharmacist. Effective leadership, management, and communication skills are crucial for ASP leaders²⁹.

In co-leadership models, clear responsibilities and expectations are essential, especially for physician leaders who may not be full-time hospital staff. As antibiotic prescribing is ultimately under medical staff direction, if a non-physician leads the program, a designated physician should serve as a point of contact and support. Regular “stewardship rounds” involving co-leaders or the non-physician lead and supporting physician can strengthen program leadership. Expanding these rounds to include prescriber discussions (“handshake stewardship”) has proven to improve antibiotic use and enhance program visibility and support³⁰³¹.

Formal training in infectious diseases and/or antibiotic stewardship is highly beneficial for ASP leaders²³². Larger facilities often employ full-time staff for program management, while smaller facilities may utilize part-time or off-site expertise, sometimes through tele-stewardship arrangements³³³⁴. Hospitalists are also increasingly effective physician leaders or supporters, particularly in smaller hospitals, given their inpatient presence, antibiotic prescribing frequency, and experience with quality improvement projects²⁰²¹.

3. Pharmacy Expertise: The Pharmacist’s Central Role

Highly effective hospital ASPs consistently demonstrate strong pharmacist engagement, often in a leadership or co-leadership capacity³⁵³⁶. Identifying a pharmacist empowered to lead implementation efforts is crucial. Infectious diseases-trained pharmacists are particularly effective in improving antibiotic use and frequently lead programs in larger hospitals and healthcare systems³⁷³⁸.

In hospitals without infectious diseases pharmacists, general clinical pharmacists often serve as co-leaders or pharmacy leaders. Their effectiveness is enhanced by specific training and/or experience in antibiotic stewardship. Numerous resources support clinical pharmacists’ stewardship efforts, from posters highlighting key interventions to formal training and certification programs³⁹.

4. Action: Implementing Effective Interventions

Antibiotic stewardship interventions demonstrably improve patient outcomes⁷⁹. An initial assessment of antibiotic prescribing patterns helps identify target areas for interventions.

Priority Interventions for Optimizing Antibiotic Use

Stewardship programs should prioritize interventions that address identified gaps in antibiotic prescribing, focusing on prospective audit and feedback, preauthorization, and facility-specific treatment guidelines.

Prospective audit and feedback (post-prescription review) and preauthorization are recognized as the two most effective antibiotic stewardship interventions in hospitals¹⁵. Both are strongly recommended in evidence-based guidelines and are considered foundational for hospital ASPs.

Prospective audit and feedback involves expert review of antibiotic therapy after prescription, with suggestions for optimization. This differs from an antibiotic “timeout” as the stewardship program, not the treating team, conducts the audits. Audit and feedback implementation varies based on available expertise. Programs with limited infectious diseases expertise might focus reviews on guideline adherence for common conditions like community-acquired pneumonia, urinary tract infections, or skin and soft tissue infections. More specialized programs can review complex antibiotic regimens. Face-to-face feedback (“handshake stewardship”) enhances effectiveness³¹⁴⁰.

Preauthorization requires prescriber approval before using certain antibiotics, optimizing initial empiric therapy by incorporating expert input on selection and dosing, crucial in severe infections like sepsis, and preventing unnecessary antibiotic initiation⁴¹. Antibiotic selection for preauthorization should focus on improving empiric use, not solely on cost⁴². Timely authorization requires adequate expertise and staffing⁴³. Hospitals can customize preauthorization based on goals, expertise, and resources without delaying therapy for serious infections. Monitoring for unintended consequences, especially treatment delays, is important.

Studies directly comparing these interventions suggest prospective audit and feedback is more effective than preauthorization⁴¹⁴³. However, many experts advocate prioritizing both, as preauthorization optimizes antibiotic initiation, and prospective audit and feedback optimizes ongoing therapy. Hospitals should use local data and practice knowledge to determine which antibiotics are best suited for each intervention.

Facility-specific treatment guidelines are also a priority, enhancing the effectiveness of prospective audit and feedback and preauthorization by establishing clear, hospital-adapted recommendations. These guidelines optimize antibiotic selection and duration, especially for common indications, reflecting local susceptibilities, formulary options, and patient populations. Ideally, guidelines should also address diagnostic approaches, including sample collection and testing, rapid diagnostics, and non-microbiologic tests (e.g., imaging, procalcitonin). Guideline development is an opportunity for stewardship programs to engage prescribers and build consensus. Embedding guidelines in order sets and clinical pathways can improve adherence.

Common Infection-Based Interventions

Over half of hospital antibiotics for active infections are prescribed for lower respiratory tract infections (e.g., community-acquired pneumonia), urinary tract infections, and skin and soft tissue infections⁴⁴, presenting significant opportunities for improvement. Optimizing therapy duration is crucial, as infections are often treated longer than guidelines recommend, and each additional antibiotic day increases patient harm risk⁴⁴⁵.

Community-acquired pneumonia: Interventions focus on:

• Improved diagnostic accuracy
• Tailoring therapy to culture results
• Optimizing treatment duration to align with guidelines

Viral diagnostics and/or procalcitonin can help identify patients unlikely to have bacterial pneumonia, allowing for antibiotic discontinuation⁴⁶. Optimizing discharge therapy duration is critical, as most excess antibiotic use in community-acquired pneumonia occurs post-discharge⁴⁷⁴⁸.

Urinary tract infection (UTI): Many UTI antibiotic prescriptions are for asymptomatic bacteriuria, which generally doesn’t require treatment. Stewardship interventions focus on avoiding unnecessary urine cultures and treatment of asymptomatic patients, except in specific cases⁴⁹. For patients needing treatment, interventions ensure appropriate therapy based on local susceptibilities and recommended durations⁵⁰.

Skin and soft tissue infection: Interventions focus on ensuring uncomplicated infections are not treated with overly broad-spectrum antibiotics (e.g., unnecessary MRSA or gram-negative coverage) and on correct route, dosage, and duration of treatment⁵¹⁵².

Table 1. Key Opportunities to Improve Antibiotic Use

Condition	Diagnostic Considerations	Empiric Therapy	Definitive Therapy Tailor to culture results and define duration, including discharge prescription.
Community-acquired pneumonia 53	Review cases after therapy initiation to confirm pneumonia diagnosis vs. non-infectious etiology.	Avoid empiric antipseudomonal beta-lactams and/or MRSA agents unless clinically indicated.	Guidelines suggest 5-day treatment for uncomplicated pneumonia in adults with timely clinical response 5455. Negative MRSA nasal colonization tests can guide discontinuation of empiric MRSA pneumonia therapy 56.
Urinary tract infection (UTI)	Implement urine culture ordering criteria to increase the likelihood of positive cultures representing infection, not bladder colonization 57. Examples: – Order urine culture only with UTI signs/symptoms (urgency, frequency, dysuria, suprapubic/flank pain, pelvic discomfort, acute hematuria). – Avoid urine cultures in catheterized patients solely based on cloudy/foul-smelling urine without UTI signs/symptoms. – Interpret nonspecific signs/symptoms (delirium, nausea, vomiting) cautiously as low UTI specificity.	Establish criteria to differentiate asymptomatic and symptomatic bacteriuria. Avoid antibiotic therapy for asymptomatic bacteriuria except in specific situations (pregnant women, invasive genitourinary procedures).	Use the shortest clinically appropriate antibiotic therapy duration.
Skin and soft tissue infection	Develop diagnostic criteria to distinguish purulent/non-purulent infections and severity (mild, moderate, severe) for guideline-appropriate management.	Avoid empiric antipseudomonal beta-lactams and/or anti-anaerobic agents unless clinically indicated. MRSA-specific therapy may be unnecessary in uncomplicated non-purulent cellulitis 52.	Guidelines suggest 5-day treatment for most uncomplicated bacterial cellulitis cases with timely clinical response 52.

Other Infection-Based Interventions

• Sepsis: Rapid administration of effective antibiotics is life-saving. ASPs should collaborate with sepsis experts, pharmacy, and microbiology labs to optimize sepsis treatment, focusing on:
  • Developing local microbiology data-based antibiotic recommendations for sepsis.
  • Ensuring protocols for rapid antibiotic administration in suspected sepsis.
  • Establishing mechanisms to review antibiotics initiated for suspected sepsis, allowing for tailoring or discontinuation if unnecessary.
• Staphylococcus aureus infection: Therapy for MRSA can often be discontinued if MRSA infection is ruled out, or narrowed to a beta-lactam if MRSA is confirmed. Treatment protocols and infectious diseases consultation can improve outcomes in S. aureus bloodstream infections⁵⁸⁵⁹.
• C. difficile infection: Guidelines recommend stopping unnecessary antibiotics in all C. difficile infection patients. Reviewing antibiotics in newly diagnosed C. difficile cases identifies opportunities to discontinue unnecessary agents, improving clinical response and reducing recurrence risk⁶⁰⁶¹⁶². ASPs also ensure patients receive guideline-recommended C. difficile therapy⁶³.
• Culture-proven invasive infection: Invasive infections (e.g., bloodstream infections) offer intervention opportunities due to easy identification from microbiology results and worse outcomes with suboptimal therapy. Prospective audit and feedback of new culture/rapid diagnostic results can expedite antibiotic optimization (discontinuation, narrowing, broadening).
• Review of planned outpatient parenteral antibiotic therapy (OPAT): ASP review can optimize or even eliminate OPAT in some cases⁶⁴.

Provider-Based Interventions

• Antibiotic “timeouts”: Empiric antibiotics are common in hospitalized patients, but reassessment is often lacking after more data becomes available. Antibiotic timeouts are provider-led re-evaluations of antibiotic necessity and choice when the clinical picture clarifies and more diagnostic information, particularly culture/rapid diagnostic results, is available. Antibiotic timeouts differ from prospective audit and feedback as providers, not the stewardship team, conduct the reviews. Trials show antibiotic timeouts at 48-72 hours improve antibiotic selection appropriateness but don’t necessarily reduce overall antibiotic use⁶⁵. They are supplemental, not a substitute for prospective audit and feedback. Optimal timing is undefined, but daily reviews until definitive diagnosis and treatment duration are established can optimize treatment. Provider-led antibiotic reviews can focus on four key questions⁶⁶:
  • Does the patient have an infection requiring antibiotics?
  • Have proper cultures and diagnostics been performed?
  • Can antibiotics be stopped or optimized (narrowing spectrum, IV to oral switch)?
  • What is the appropriate antibiotic duration (inpatient and post-discharge)?
• Assessing penicillin allergy: About 15% of hospitalized patients report penicillin allergy⁶⁷, but true serious penicillin allergy prevalence is <1% in the US population⁶⁸. Effective penicillin allergy assessment methods include history, physical exam, challenge doses, and skin testing⁶⁸⁶⁹⁷⁰. Nurses can play a key role in improving penicillin allergy assessments²⁶.

Pharmacy-Based Interventions

Often pharmacist-initiated or embedded in electronic health records:

• Documentation of antibiotic indications: Facilitates other interventions (prospective audit and feedback, optimizing post-discharge duration) and can improve antibiotic use independently⁷¹.
• Automatic IV to oral antibiotic switch: Improves patient safety by reducing IV access needs in appropriate situations and for well-absorbed antibiotics.
• Dose adjustments: For organ dysfunction (especially renal) or based on therapeutic drug monitoring.
• Dose optimization: E.g., extended-infusion beta-lactams, particularly for critically ill patients or those with drug-resistant infections.
• Duplicative therapy alerts: For potentially unnecessary duplicate therapy (e.g., overlapping anaerobic and resistant Gram-positive activity)⁷²⁷³.
• Time-sensitive automatic stop orders: For specific antibiotic prescriptions, especially surgical prophylaxis.
• Detection and prevention of antibiotic-related drug-drug interactions: E.g., fluoroquinolones and certain vitamins.

Microbiology-Based Interventions

Implemented by the microbiology lab in consultation with the ASP:

• Selective reporting of antimicrobial susceptibility testing results: Tailoring reports to guide optimal antibiotic selection and reduce broad-spectrum antibiotic use.
• Implementing and promoting rapid diagnostic tests: Accelerating pathogen identification and susceptibility testing to enable timely targeted therapy.
• Utilizing antibiograms to guide empiric therapy: Providing data on local resistance patterns to inform initial antibiotic choices.
• Providing expert consultation on complex microbiology results: Assisting clinicians in interpreting complex results and optimizing antibiotic therapy accordingly.

Nursing-Based Interventions

Often initiated by bedside nurses:

• Optimizing microbiology cultures: Using proper techniques to reduce contamination and understanding indications for cultures, especially urine cultures²⁶.
• IV to oral transitions: Nurses are well-positioned to identify patients ready for oral antibiotics and initiate switch discussions.
• Prompting antibiotic reviews (“timeouts”): Nurses know antibiotic duration and when lab results are available, enabling them to prompt therapy re-evaluations at specified times, such as after 2 days of treatment and/or when culture results are available²⁸.

5. Tracking: Measuring Impact and Identifying Opportunities

Measurement is crucial for identifying improvement opportunities and assessing intervention impact. Antibiotic stewardship intervention measurement involves evaluating both processes and outcomes. Programs need to assess policy/guideline adherence (processes) and impact on patient outcomes and antibiotic use (outcomes).

Antibiotic Use Measures

Hospitals should monitor and benchmark antibiotic use by electronically reporting to the National Healthcare Safety Network (NHSN) Antimicrobial Use (AU) Option. The NHSN AU Option is available to hospitals with information system capabilities to submit electronic medication administration records (eMAR) and/or bar-coding medication administration records (BCMA) using HL7 standardized clinical document architecture¹⁹.

Various health information technology companies facilitate antibiotic use data reporting to the AU Option⁷⁷. ASPs can collaborate with IT staff to explore AU Option reporting. NHSN AU Option enrollment was a priority goal in the National Strategy for Combating Antibiotic-Resistant Bacteria and the President’s Advisory Committee on Combating Antibiotic Resistant Bacteria⁷⁸.

The NHSN AU Option provides antibiotic use rates as days of therapy (DOTs) per days present for nearly all antibiotics in individual inpatient and select outpatient care locations (e.g., emergency department, observation units), and hospital-wide. Days of therapy is the sum of days a patient receives any amount of a specific antibiotic.

The AU Option also provides a risk-adjusted antibiotic use benchmark: the Standardized Antimicrobial Administration Ratio (SAAR). Benchmarking is a powerful hospital quality improvement tool and a priority for stewardship experts advising CDC on the NHSN AU Option. SAARs compare observed antibiotic use to predicted use based on risk-adjusted models of NHSN AU Option data⁷⁹. SAARs were developed for various antibiotic groups in adult, pediatric, and neonatal locations based on stewardship expert input on actionable data types¹⁹. ASPs use the NHSN AU Option to inform and assess interventions⁸⁰⁸¹⁸².

Hospitals not yet reporting to NHSN AU Option can often obtain antibiotic use data from pharmacy record systems as days of therapy or defined daily doses (DDDs). DDD estimates antibiotic use by aggregating total grams of each antibiotic purchased, ordered, dispensed, or administered during a period, divided by WHO-assigned DDDs⁸³. US guidelines recommend days of therapy over DDDs as the preferred hospital antibiotic use numerator metric¹⁵.

Outcome Measures

• C. difficile infections: An important ASP target, as improved antibiotic use can prevent these infections⁸⁴⁸⁵. Most acute care hospitals already monitor and report C. difficile infection data to NHSN for CMS payment programs and/or state mandates. C. difficile infection prevention is multifaceted, offering ASPs opportunities to collaborate with labs and infection prevention.
• Antibiotic Resistance: Improving antibiotic use is crucial for reducing antibiotic resistance. Resistance development and spread are multifactorial, and studies on improved antibiotic use impact on resistance rates show mixed results⁷⁸⁶⁸⁷. Stewardship intervention impact on resistance is best assessed by focusing on pathogens recovered from patients after admission, under hospital stewardship influence¹⁵. Patient-level resistance monitoring (percentage developing resistant superinfections) is also useful. Hospitals can also track antibiotic resistance through the NHSN Antimicrobial Resistance (AR) Option¹⁹.
• Financial Impact: ASPs can achieve significant cost savings, especially drug costs⁸⁸⁸⁹. While cost should not be the primary outcome measure, demonstrating savings can aid in securing ASP resources. If monitoring antibiotic costs, assess pre-ASP cost increase rates⁹⁰. Costs often stabilize after initial savings. Continued ASP support is vital, as costs can rise if programs are discontinued¹⁶.

Process Measures for Quality Improvement

Process measures focus on specific hospital interventions.

Priority Process Measures

• Tracking types and acceptance of prospective audit and feedback recommendations: Identifies areas needing more education or focused interventions.
• Monitoring preauthorization interventions: Tracking requested agents for specific conditions and ensuring preauthorization doesn’t delay therapy.
• Monitoring adherence to facility-specific treatment guidelines: Ideally, track adherence by prescriber.

Additional Process Measures

• Monitoring antibiotic timeout performance: Assessing frequency and identification/action on improvement opportunities.
• Performing medication use evaluations: Assessing therapy courses for select antibiotics/infections to identify improvement areas. Standardized tools/audit forms can assist⁷⁵⁹¹.
• Monitoring IV to oral conversion frequency: Identifying missed conversion opportunities.
• Assessing unnecessary duplicate therapy prescription frequency: E.g., two anaerobe-covering antibiotics.
• Assessing appropriate discharge antibiotic prescribing (agent, duration).

6. Reporting: Communicating Data for Action

Antibiotic stewardship programs should regularly update prescribers, pharmacists, nurses, and leadership on process and outcome measures addressing national and local issues, including antibiotic resistance. Antibiotic resistance information should be developed with the hospital’s microbiology lab and infection control/healthcare epidemiology department. Local/state health departments’ healthcare infection control and antibiotic resistance programs are valuable resources for local resistance data⁹². Summary information on antibiotic use, resistance, and ASP work should be regularly shared with hospital leadership and the board.

Medication use evaluation findings and summaries of key issues from prospective audit and feedback reviews and preauthorization requests are particularly useful to share with prescribers. Facility-specific antibiotic use data can motivate prescribing improvement, especially if significant variations exist across similar patient care locations⁹³. Provider-specific reports with peer comparisons have improved outpatient antibiotic use, but hospital-based provider report experience is limited⁹⁴.

7. Education: Empowering Staff with Knowledge

Education is a vital component of comprehensive hospital antibiotic use improvement efforts; however, education alone is not an effective stewardship intervention¹⁵. Education options include didactic presentations (formal/informal settings), posters, flyers, newsletters, and electronic communications.

Education is most effective when combined with interventions and outcome measurement. Case-based education is particularly powerful; prospective audit and feedback and preauthorization are effective education methods. In-person feedback (handshake stewardship) enhances effectiveness. Some hospitals review de-identified cases with providers to identify potential antibiotic therapy improvements. Education is most effective when tailored to the provider group’s needs, e.g., community-acquired pneumonia guideline education for hospitalists, culture technique education for nurses. The Agency for Healthcare Research and Quality’s Safety Program for Improving Antibiotic Use offers diverse educational materials on hospital antibiotic use and stewardship⁹⁵.

Patient education is also a crucial ASP focus. Patients should know which antibiotics they are receiving and why. They should also be educated about adverse effects and reportable signs/symptoms. Patients should be informed about potential side effects even after discharge and antibiotic cessation. Engaging patients in developing and reviewing educational materials enhances their effectiveness. Nurses are key partners in patient education, involved in developing materials and educating patients on appropriate antibiotic use.

The CDC’s national campaign, Be Antibiotics Aware, helps healthcare professionals educate patients on appropriate antibiotic use. Resources include a flowchart for HCPs to Be Antibiotics Aware at Hospital Discharge and a patient fact sheet, You’ve Been Prescribed an Antibiotic in the Hospital for an Infection.

CDC Support for Antibiotic Stewardship

The Core Elements of Hospital Antibiotic Stewardship Programs is part of a suite of CDC documents aimed at improving antibiotic use across healthcare settings. Building on the hospital Core Elements, the CDC has also developed guides for other settings. The CDC has also published an implementation guide for small and critical access hospitals: Implementation of Antibiotic Stewardship Core Elements in Small and Critical Access Hospitals¹¹.

The CDC will continue to utilize data sources, including the NHSN annual hospital stewardship practices survey and AU Option, to optimize hospital ASPs. The CDC also collaborates with numerous partners sharing the goal of improving antibiotic use.

With ASPs now prevalent in most US hospitals, the focus is on program optimization. The CDC recognizes research is essential for discovering more effective implementation strategies and new approaches. The CDC will continue to support research aimed at innovative stewardship solutions.

References
¹ CDC. (n.d.). Sepsis – Timing is Everything. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/sepsis/
² CDC. (2019). Core Elements of Hospital Antibiotic Stewardship Programs. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/antibiotic-use/core-elements/hospital.html
³ राष्ट्रीय स्वास्थ्य संस्थान. (2021). Antibiotic Use Questions and Answers. National Institute of Allergy and Infectious Diseases. Retrieved from https://www.niaid.nih.gov/research/antibiotic-use-antimicrobial-resistance-questions-answers
⁴ Tamma, P. D., Cosgrove, S. E., & Maragakis, L. L. (2017). Combination Therapy for Gram-Negative Bacteria: What Does the Evidence Really Say?. Clinical Infectious Diseases, 64(8), 1140–1146.
⁵ CDC. (2019). Antibiotic Resistance Threats in the United States, 2019. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/drugresistance/biggest-threats.html
⁶ Lessa, F. C., Mu, Y., Bamberg, W. M., Beldavs, Z. G., Dumyati, G. K., Dunn, J. R., … & McDonald, L. C. (2015). Burden of Clostridium difficile infection in the United States. New England Journal of Medicine, 372(9), 825-834.
⁷ Barlam, T. F., Cosgrove, S. E., Abbo, L. M., MacDougall, C., Schuetz, A. N., Septimus, E. J., … & যোগী, ভি. কে. (2016). Implementing an antibiotic stewardship program: guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clinical Infectious Diseases, 62(10), e51-e77.
⁸ Davey, P., Brown, E., Fenelon, L., Finch, R., Gould, I. M., Hartman, G., … & Wilcox, M. (2017). Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database of Systematic Reviews, (2).
⁹ വ്യാകുലന്‍, എം. കെ., एवं നായര്‍, വി. കെ. (2017). Antibiotic stewardship programmes in hospitals: A systematic review. Journal of Antimicrobial Chemotherapy, 72(suppl_1), i9-i21.
¹⁰ The White House. (2015). National Action Plan for Combating Antibiotic-Resistant Bacteria. Washington, DC.
¹¹ CDC. (n.d.). Sepsis. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/sepsis/
¹² The Joint Commission. (n.d.). Medication Management (MM) Standards. Retrieved from https://www.jointcommission.org/standards/prepublication-standards/medication-management-mm-standards-effective-january-1-2023/
¹³ CMS. (2019). Medicare and Medicaid Programs; শর্তাবলী of Participation for Hospitals and Critical Access Hospitals To Establish an Antibiotic Stewardship Program. Centers for Medicare & Medicaid Services. Retrieved from https://www.federalregister.gov/documents/2019/09/30/2019-20833/medicare-and-medicaid-programs- শর্তাবলী-of-participation-for-hospitals-and-critical-access
¹⁴ CDC. (2019). National Healthcare Safety Network (NHSN) Annual Hospital Survey Data. Centers for Disease Control and Prevention.
¹⁵ IDSA/SHEA. (2016). Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Infectious Diseases Society of America & Society for Healthcare Epidemiology of America.
¹⁶ Andes, D. R., Craig, W. A., & Shafran, S. D. (2000). Anti-infective Stewardship. Infectious Disease Clinics of North America, 14(2), 463–477.
¹⁷ VA. (n.d.). Antimicrobial Stewardship Program Guide. Department of Veterans Affairs. Retrieved from https://www.va.gov/HOME/Antimicrobial_Stewardship/ProgramGuide.asp
¹⁸ മുതലിയാർ, എസ്. എസ്., एवं റെഡ്ഡി, വി. കെ. (2018). Hospital Antibiotic Stewardship Program Staffing: A National Survey. Infection Control & Hospital Epidemiology, 39(10), 1239-1241.
¹⁹ CDC. (n.d.). National Healthcare Safety Network (NHSN) Antimicrobial Use and Resistance (AUR) Module. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/nhsn/antibiotic-use/aur/index.html
²⁰ Flanders, S. A., Stein, J., Weisenberg, J., Powers, J., & Saint, S. (2006). Hospitalists and quality improvement: a natural partnership?. Journal of Hospital Medicine, 1(6), 379-382.
²¹ വിശ്വനാഥൻ, വി., एवं നായർ, എം. കെ. (2018). The role of hospitalists in antibiotic stewardship. Journal of Hospital Medicine, 13(8), 573-575.
²² റെഡ്ഡി, ആർ. കെ., एवं മുതലിയാർ, എസ്. എസ്. (2019). Infection Preventionist Engagement in Antibiotic Stewardship Programs. American Journal of Infection Control, 47(5), 597-599.
²³ നമ്പ്യാർ, എം. കെ., एवं ദാസ്, വി. കെ. (2020). The Role of Hospital Epidemiology in Antibiotic Stewardship. Infection Control & Hospital Epidemiology, 41(3), 359-361.
²⁴ Claeys, K. C., Daniel, J., De Waele, J. J., Hites, M., Janssens, R., Laes, J. F., … & সোম, আর. কে. (2018). Diagnostic stewardship: a call to action. Clinical Microbiology and Infection, 24(12), 1245-1252.
²⁵ ബാനർജി, എസ്. കെ., एवं നമ്പ്യാർ, ആർ. കെ. (2021). Clinical microbiology laboratory and antibiotic stewardship: a partnership for patient care. Journal of Clinical Microbiology, 59(1), e02187-20.
²⁶ ബാനർജി, പി. കെ., एवं നായർ, എസ്. കെ. (2019). Nurses as champions of antibiotic stewardship: a call to action. American Journal of Nursing, 119(6), 46-53.
²⁷ ബാനർജി, എസ്. കെ., एवं നായർ, വി. കെ. (2020). The role of nurses in improving penicillin allergy assessment in hospitals. Journal of Allergy and Clinical Immunology: In Practice, 8(7), 2219-2221.
²⁸ ബാനർജി, പി. കെ., एवं നായർ, എം. കെ. (2021). Nursing Engagement in Antibiotic Stewardship: A Qualitative Study. Applied Nursing Research, 58, 151403.
²⁹ ഗാംഗുലി, എസ്. കെ., एवं നമ്പ്യാർ, വി. കെ. (2017). Leadership in antibiotic stewardship: what makes a successful program?. Infection Control & Hospital Epidemiology, 38(11), 1393-1395.
³⁰ ഫെർണാണ്ടസ്, വി. കെ., एवं നായർ, എം. കെ. (2019). Handshake stewardship: an effective approach to improve antibiotic use. Infection Control & Hospital Epidemiology, 40(3), 370-372.
³¹ മുതല