The Core Elements Of Hospital Antibiotic Stewardship Programs

Summary

The Core Elements of
Hospital Antibiotic Stewardship Programs
National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
CORE ELEMENTS OF HOSPITAL ANTIBIOTIC STEWARDSHIP PROGRAMS 1
CS273578-A
Core Elements of Hospital Antibiotic Stewardship Programs is
a publication of The National Center for Emerging and Zoonotic
Infectious Diseases within the Centers for Disease Control and
Prevention

Centers for Disease Control and Prevention
Thomas R. Frieden, MD, MPH, Director
National Center for Emerging and Zoonotic Infectious Diseases
Beth P. Bell, MD, MPH, Director
Suggested citation:
CDC. Core Elements of Hospital Antibiotic Stewardship Programs

Atlanta, GA: US Department of Health and Human Services, CDC;
2014. Available at http://www.cdc.gov/getsmart/healthcare/
implementation/core-elements.html

2 CENTERS FOR DISEASE CONTORL AND PREVENTION
Introduction
Antibiotics have transformed the practice of medicine, making
once lethal infections readily treatable and making other medical
advances, like cancer chemotherapy and organ transplants, possible

The prompt initiation of antibiotics to treat infections has been
proven to reduce morbidity and save lives, with a recent example
being the rapid administration of antibiotics in the management of
sepsis.1 However, 20–50% of all antibiotics prescribed in U.S. acute
care hospitals are either unnecessary or inappropriate.2–7 Like all
medications, antibiotics have serious side effects, including adverse
drug reactions and Clostridium difficile infection (CDI).8–11 Patients
who are unnecessarily exposed to antibiotics are placed at risk
for serious adverse events with no clinical benefit. The misuse of
antibiotics has also contributed to the growing problem of antibiotic
resistance, which has become one of the most serious and growing
threats to public health.12 Unlike other medications, the potential for
spread of resistant organisms means that the misuse of antibiotics
can adversely impact the health of patients who are not even
exposed to them. The Centers for Disease Control and Prevention
(CDC) estimates more than two million people are infected with
antibiotic-resistant organisms, resulting in approximately 23,000
deaths annually.13
Improving the use of antibiotics is an important patient safety
and public health issue as well as a national priority.14 The 2006
CDC guideline “Management of Multi-Drug Resistant Organisms
in Healthcare Settings” stated that control of multi-drug resistant
organisms in healthcare “must include attention to judicious
antimicrobial use.”15 In 2009, CDC launched the “Get Smart for
Healthcare Campaign” to promote improved use of antibiotics in
acute care hospitals and in 2013;16 the CDC highlighted the need
to improve antibiotic use as one of four key strategies required to
address the problem of antibiotic resistance in the U.S.13
A growing body of evidence demonstrates that hospital based
programs dedicated to improving antibiotic use, commonly referred
to as “Antibiotic Stewardship Programs (ASPs),” can both optimize
the treatment of infections and reduce adverse events associated
with antibiotic use.17, 18 These programs help clinicians improve the
quality of patient care19 and improve patient safety through increased
infection cure rates, reduced treatment failures, and increased
frequency of correct prescribing for therapy and prophylaxis.20, 21
They also significantly reduce hospital rates of CDI22–24 and antibiotic
resistance.25, 26 Moreover these programs often achieve these benefits
while saving hospitals money.17, 27–30 In recognition of the urgent need
CORE ELEMENTS OF HOSPITAL ANTIBIOTIC STEWARDSHIP PROGRAMS 3
to improve antibiotic use in hospitals and the benefits of antibiotic
stewardship programs, in 2014 CDC recommended that all acute
care hospitals implement Antibiotic Stewardship Programs.7
This document summarizes core elements of successful hospital
Antibiotic Stewardship Programs. It complements existing
guidelines on ASPs from organizations including the Infectious
Diseases Society of America in conjunction with the Society for
Healthcare Epidemiology of America, American Society of Health
System Pharmacists, and The Joint Commission.6, 31, 32 There is no
single template for a program to optimize antibiotic prescribing in
hospitals. The complexity of medical decision making surrounding
antibiotic use and the variability in the size and types of care
among U.S. hospitals require flexibility in implementation. However,
experience demonstrates that antibiotic stewardship programs can
be implemented effectively in a wide variety of hospitals and that
success is dependent on defined leadership and a coordinated
multidisciplinary approach.33–36
Summary of Core Elements of Hospital
Antibiotic Stewardship Programs
• Leadership Commitment: Dedicating necessary human,
financial and information technology resources

• Accountability: Appointing a single leader responsible for
program outcomes. Experience with successful programs
show that a physician leader is effective

• Drug Expertise: Appointing a single pharmacist leader
responsible for working to improve antibiotic use

• Action: Implementing at least one recommended action,
such as systemic evaluation of ongoing treatment need after
a set period of initial treatment (i.e. “antibiotic time out” after
48 hours)

• Tracking: Monitoring antibiotic prescribing and resistance
patterns

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

• Education: Educating clinicians about resistance and
optimal prescribing

4 CENTERS FOR DISEASE CONTORL AND PREVENTION
Leadership Commitment
Leadership support is critical to the success of antibiotic stewardship
programs and can take a number of forms, including:
• Formal statements that the facility supports efforts to improve
and monitor antibiotic use

• Including stewardship-related duties in job descriptions and
annual performance reviews

• Ensuring staff from relevant departments are given sufficient
time to contribute to stewardship activities

• Supporting training and education

• Ensuring participation from the many groups that can support
stewardship activities

Financial support greatly augments the capacity and impact of a
stewardship program and stewardship programs will often pay for
themselves, both through savings in both antibiotic expenditures and
indirect costs.17, 27–30
Accountability and Drug Expertise
• Stewardship program leader: Identify a single leader who
will be responsible for program outcomes. Physicians have
been highly effective in this role.6
• Pharmacy leader: Identify a single pharmacy leader who will
co-lead the program

Formal training in infectious diseases and/or antibiotic stewardship
benefits stewardship program leaders.6, 37, 38 Larger facilities
have achieved success by hiring full time staff to develop and
manage stewardship programs while smaller facilities report other
arrangements, including use of part-time, off-site expertise and
hospitalists.33 Hospitalists can be ideal physician leaders for efforts to
improve antibiotic use given their increasing presence in inpatient care,
the frequency with which they use antibiotics and their commitment to
quality improvement.37, 38 The Pharmacy and Therapeutics committee
should not be considered the stewardship team within a hospital
if only performing its traditional duties of managing the formulary
and monitoring drug-related patient safety, though in some smaller
facilities the pharmacy and therapeutics committee has expanded its
role to assess and improve antibiotic use.33–36
CORE ELEMENTS OF HOSPITAL ANTIBIOTIC STEWARDSHIP PROGRAMS 5
Key Support
The work of stewardship program leaders is greatly enhanced by the
support of other key groups in hospitals where they are available

• Clinicians and department heads. As the prescribers of
antibiotics, it is vital that clinicians are fully engaged in and
supportive of efforts to improve antibiotic use in hospitals

• Infection preventionists and hospital epidemiologists
coordinate facility-wide monitoring and prevention of
healthcare-associated infections and can readily bring their
skills to auditing, analyzing and reporting data. They can
also assist with monitoring and reporting of resistance and
CDI trends, educating staff on the importance of appropriate
antibiotic use, and implementing strategies to optimize the
use of antibiotics.39
• Quality improvement staff can also be key partners given
that optimizing antibiotic use is a medical quality and patient
safety issue

• Laboratory staff can guide the proper use of tests and the
flow of results. They can also guide empiric therapy by creating
and interpreting a facility cumulative antibiotic resistance
report, known as an antibiogram. Lab and stewardship staff
can work collaboratively to ensure that lab reports present
data in a way that supports optimal antibiotic use. For facilities
that have laboratory services performed offsite, information
provided should be useful to stewardship efforts and contracts
should be written to ensure this is the case

• Information technology staff are critical to integrating
stewardship protocols into existing workflow. Examples
include embedding relevant information and protocols at
the point of care (e.g., immediate access to facility-specific
guidelines at point of prescribing); implementing clinical
decision support for antibiotic use; creating prompts for
action to review antibiotics in key situations and facilitating
the collection and reporting of antibiotic use data.40–45
• Nurses can assure that cultures are performed before starting
antibiotics. In addition, nurses review medications as part of
their routine duties and can prompt discussions of antibiotic
treatment, indication, and duration.46, 47
6 CENTERS FOR DISEASE CONTORL AND PREVENTION
Implement Policies and Interventions
to Improve Antibiotic Use
Key points
• Implement policies that support optimal antibiotic use

• Utilize specific interventions that can be divided into three
categories: broad, pharmacy driven and infection and
syndrome specific

• Avoid implementing too many policies and interventions
simultaneously; always prioritize interventions based on the
needs of the hospital as defined by measures of overall use
and other tracking and reporting metrics

Policies that support optimal antibiotic use
Implement policies that apply in all situations to support optimal
antibiotic prescribing, for example:
• Document dose, duration, and indication. Specify the dose,
duration and indication for all courses of antibiotics so they
are readily identifiable. Making this information accessible
helps ensure that antibiotics are modified as needed and/or
discontinued in a timely manner.4, 48, 49
• Develop and implement facility specific treatment
recommendations. Facility-specific treatment
recommendations, based on national guidelines and local
susceptibilities and formulary options can optimize antibiotic
selection and duration, particularly for common indications
for antibiotic use like community-acquired pneumonia, urinary
tract infection, intra-abdominal infections, skin and soft tissue
infections and surgical prophylaxis

Interventions to improve antibiotic use
Choose interventions based on the needs of the facility as well as the
availability of resources and content expertise; stewardship programs
should be careful not to implement too many interventions at once.50
Many potential interventions are highlighted in the CDC/Institute for
Healthcare Improvement “Antibiotic Stewardship Driver Diagram
and Change Package.”51 Assessments of the use of antibiotics as
mentioned in the “Process Measures” section of this document can
be a starting point for selecting specific interventions.52
Stewardship interventions are listed in three categories below: broad,
pharmacy-driven; and infection and syndrome specific

CORE ELEMENTS OF HOSPITAL ANTIBIOTIC STEWARDSHIP PROGRAMS 7
Broad interventions
• Antibiotic “Time outs.” Antibiotics are often started
empirically in hospitalized patients while diagnostic information
is being obtained. However, providers often do not revisit the
selection of the antibiotic after more clinical and laboratory
data (including culture results) become available.53–56 An
antibiotic “time out” prompts a reassessment of the continuing
need and choice of antibiotics when the clinical picture is
clearer and more diagnostic information is available. All
clinicians should perform a review of antibiotics 48 hours after
antibiotics are initiated to answer these key questions:
Does this patient have an infection that will respond
to antibiotics?
If so, is the patient on the right antibiotic(s), dose, and
route of administration?
Can a more targeted antibiotic be used to treat the
infection (de-escalate)?
How long should the patient receive the antibiotic(s)?
• Prior authorization. Some facilities restrict the use of certain
antibiotics based on the spectrum of activity, cost, or associated
toxicities57 to ensure that use is reviewed with an antibiotic
expert before therapy is initiated. This intervention requires the
availability of expertise in antibiotic use and infectious diseases
and authorization needs to be completed in a timely manner

• Prospective audit and feedback. External reviews of antibiotic
therapy by an expert in antibiotic use have been highly effective
in optimizing antibiotics in critically ill patients and in cases
where broad spectrum or multiple antibiotics are being used.25, 58,
59
Prospective audit and feedback is different from an antibiotic
”time out” because the audits are conducted by staff other than
the treating team. Audit and feedback requires the availability
of expertise and some smaller facilities have shown success by
engaging external experts to advise on case reviews.33
Pharmacy-driven Interventions
• Automatic changes from intravenous to oral antibiotic
therapy in appropriate situations and for antibiotics with
good absorption (e.g., fluoroquinolones, trimethoprim-
sulfamethoxazole, linezolid, etc.),60, 61 which improves patient
safety by reducing the need for intravenous access

8 CENTERS FOR DISEASE CONTORL AND PREVENTION
• Dose adjustments in cases of organ dysfunction (e.g. renal
adjustment)

• Dose optimization including dose adjustments based on
therapeutic drug monitoring, optimizing therapy for highly
drug-resistant bacteria, achieving central nervous system
penetration, extended-infusion administration of beta-
lactams, etc.62, 63
• Automatic alerts in situations where therapy might be
unnecessarily duplicative including simultaneous use of
multiple agents with overlapping spectra e.g. anaerobic
activity, atypical activity, Gram-negative activity and resistant
Gram-positive activity.64
• Time-sensitive automatic stop orders for specified
antibiotic prescriptions, especially antibiotics administered for
surgical prophylaxis.65
• Detection and prevention of antibiotic-related drug-
drug interactions e.g. interactions between some orally
administered fluoroquinolones and certain vitamins

Infection and syndrome specific interventions
The interventions below are intended to improve prescribing for
specific syndromes; however, these should not interfere with prompt
and effective treatment for severe infection or sepsis

• Community-acquired pneumonia. Interventions for
community-acquired pneumonia have focused on correcting
recognized problems in therapy, including: improving
diagnostic accuracy, tailoring of therapy to culture results and
optimizing the duration of treatment to ensure compliance
with guidelines.66–70
• Urinary tract infections (UTIs). Many patients who get
antibiotics for UTIs actually have asymptomatic bacteriuria
and not infections.71, 72 Interventions for UTIs focus on
avoiding unnecessary urine cultures and treatment of patients
who are asymptomatic and ensuring that patients receive
appropriate therapy based on local susceptibilities and for the
recommended duration.73–77
• Skin and soft tissue infections. Interventions for skin and
soft tissue infections have focused on ensuring patients do
not get antibiotics with overly broad spectra and ensuring the
correct duration of treatment.60, 78, 79
CORE ELEMENTS OF HOSPITAL ANTIBIOTIC STEWARDSHIP PROGRAMS 9
• Empiric coverage of methicillin-resistant Staphylococcus
aureus (MRSA) infections. In many cases, therapy for
MRSA can be stopped if the patient does not have an
MRSA infection or changed to a beta-lactam if the cause is
methicillin-sensitive Staphylococcus aureus.58, 80
• Clostridium difficile infections. Treatment guidelines for CDI
urge providers to stop unnecessary antibiotics in all patients
diagnosed with CDI, but this often does not occur.81–84
Reviewing antibiotics in patients with new diagnoses of CDI
can identify opportunities to stop unnecessary antibiotics
which improve the clinical response of CDI to treatment and
reduces the risk of recurrence.82, 85
• Treatment of culture proven invasive infections

Invasive infections (e.g. blood stream infections) present
good opportunities for interventions to improve antibiotic
use because they are easily identified from microbiology
results. The culture and susceptibility testing often provides
information needed to tailor antibiotics or discontinue them
due to growth of contaminants.86
Tracking and Reporting Antibiotic Use
and Outcomes
Monitoring antibiotic prescribing
Measurement is critical to identify opportunities for improvement
and assess the impact of improvement efforts.87 For antibiotic
stewardship, measurement may involve evaluation of both process
(Are policies and guidelines being followed as expected?) and
outcome (Have interventions improved antibiotic use and patient
outcomes?)

Antibiotic use process measures
Perform periodic assessments of the use of antibiotics or the
treatment of infections to determine the quality of antibiotic use

Examples include determining if prescribers have: accurately applied
diagnostic criteria for infections; prescribed recommended agents
for a particular indication; documented the indication and planned
duration of antibiotic therapy; obtained cultures and relevant tests
prior to treatment; and modified antibiotic choices appropriately to
microbiological findings. Standardized tools such as those for drug
use evaluations or antibiotic audit forms like those developed by
CDC can assist in these reviews.88 Likewise, assess if antibiotics are
10 CENTERS FOR DISEASE CONTORL AND PREVENTION
being given in a timely manner and assess compliance with hospital
antibiotic use policies such as the documentation of dose, duration
and indication or the performance of reassessments of therapy
(antibiotic time outs). These reviews can be done retrospectively
on charts which could be identified based on pharmacy records or
discharge diagnoses. If conducted over time, process reviews assess
the impact of efforts to improve use. For interventions that provide
feedback to clinicians, it is also important to document interventions
and track responses to feedback (e.g., acceptance)

Antibiotic use measures
Measure antibiotic use as either days of therapy (DOT) or defined
daily dose (DDD). DOT is an aggregate sum of days for which any
amount of a specific antimicrobial agent is administered or dispensed
to a particular patient (numerator) divided by a standardized
denominator (e.g., patient days, days present, or admissions).44, 89 If
a patient is receiving two antibiotics for 10 days, the DOT numerator
would be 20. An alternative measure of antibiotic use is defined
daily dose (DDD). This metric estimates antibiotic use in hospitals by
aggregating the total number of grams of each antibiotic purchased,
dispensed, or administered during a period of interest divided by
the World Health Organization-assigned DDD.90 DDDs are often
available in facilities with pharmacy systems that cannot calculate
DOTs. Compared to DOT, DDD estimates are not appropriate for
children, are problematic for patients with reduced drug excretion
such as renal impairment, and are less accurate for between-
facility benchmarking.91 However, DDDs can be a useful measure of
progress when tracked using a consistent methodology over time.92–95
In addition to measuring overall hospital antibiotic use, antibiotic
stewardship programs should also focus analyses on specific
antibiotic(s) and hospital locations where stewardship actions are
implemented. For example, the assessment of an intervention to
improve the treatment of community-acquired pneumonia (CAP)
would be expected to impact the use of antibiotics most commonly
used to treat CAP on medical wards, rather than surgical wards

As part of the National Healthcare Safety Network (NHSN), CDC has
developed an Antibiotic Use (AU) Option that automatically collects
and reports monthly DOT data, which can be analyzed in aggregate
and by specific agents and patient care locations. The AU module
is available to facilities that have information system capability to
submit electronic medication administration records (eMAR) and/or
bar coding medication records (BCMA) using an HL7 standardized
clinical document architecture. To participate in the AU option,
facility personnel can work with their information technology staff
and potentially with their pharmacy information software providers to
CORE ELEMENTS OF HOSPITAL ANTIBIOTIC STEWARDSHIP PROGRAMS 11
configure their system to enable the generation of standard formatted
file(s) to be imported into NHSN.44, 89 As more facilities enroll in the AU
option, CDC will begin to establish risk adjusted facility benchmarks
for antibiotic use. This type of benchmarking has been helpful in
improving outcomes in hospital infection control and has been
identified by stewardship experts as a high priority for the U.S.96
Outcome measures
Track clinical outcomes that measure the impact of interventions
to improve antibiotic use. Improving antibiotic use has a significant
impact on rates of hospital onset CDI and the current challenge
of CDI in hospitals makes this an important target for stewardship
programs.10, 18, 24, 57 An advantage of this measure is that most acute
care hospitals are already monitoring and reporting information on
CDI into NHSN as part of the Centers for Medicare and Medicaid
Services Hospital Inpatient Quality Reporting Program

Reducing antibiotic resistance is another important goal of efforts to
improve antibiotic use and presents another option for measurement

The development and spread of antibiotic resistance is multi-
factorial and studies assessing the impact of improved antibiotic
use on resistance rates have shown mixed results.97–99 The impact
of stewardship interventions on resistance is best assessed when
measurement is focused on pathogens that are recovered from
patients after admission (when patients are under the influence of the
stewardship interventions). Monitoring resistance at the patient level
(i.e. what percent of patients develop resistant super-infections) has
also been shown to be useful.99
Stewardship programs can result in significant annual drug cost
savings and even larger savings when other costs are included.18,
20, 21, 100
These savings have been helpful in garnering support for
antibiotic stewardship programs. If hospitals monitor antibiotic
costs, consideration should be given to assessing the pace at
which antibiotic costs were rising before the start of the stewardship
program.101 After an initial period of marked costs savings, antibiotic
use patterns and savings often stabilize, so continuous decreases
in antibiotic use and cost should not be expected; however, it is
important to continue support for stewardship to maintain gains as
costs can increase if programs are terminated.30
12 CENTERS FOR DISEASE CONTORL AND PREVENTION

Single template for a program to optimize antibiotic prescribing in hospitals. The complexity of medical decision making surrounding antibiotic use and the variability in the size and types of care among U.S. hospitals require flexibility in implementation. However, experience demonstrates that antibiotic stewardship programs can

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Frequently Asked Questions

Do antibiotic stewardship programs increase infection cure rates?

Hospital antibiotic stewardship programs can increase infection cure rates while reducing ( 7-9 ): In 2014, CDC called on all hospitals in the United States to implement antibiotic stewardship programs and released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals achieve this goal.

What is the antibiotic stewardship checklist?

The following checklist is a companion to CoreElementsofHospital AntibioticStewardship Programs. Thischecklistshouldbe used to systematically assess key elements andactionstoensureoptimalantibioticprescribing andlimitoveruseand misuse ofantibiotics in hospitals. CDCrecommendsthatall hospitals implementanAntibiotic StewardshipProgram.

What are the core elements of antibiotic stewardship?

CDC’s Core Elements of Antibiotic Stewardship offer providers and facilities a set of key principles to guide efforts to improve antibiotic use and, therefore, advance patient safety and improve outcomes.

What are the core elements of stewardship?

The Core Elements outlines structural and procedural components that are associated with successful stewardship programs. In 2015, The United States National Action Plan for Combating Antibiotic Resistant Bacteria set a goal for implementation of the Core Elements in all hospitals that receive federal funding.