This was presented as a continuing education credit for the attendees of the 17th Annual South Florida Residency Seminar in Miami Florida.

1. IDSA Practice Guidelines for
Antimicrobial Stewardship
Programs
Dr. Joy A. Awoniyi, PharmD.
PGY1 Clinical Pharmacy Practice Resident
Miami VA Healthcare System
17th Annual South Florida Residency Seminar
Saturday, January 26, 2013
1

2. Objectives
 To provide a background on the implementation and
utilization of Antimicrobial Stewardship Programs (ASPs)
 To discuss the role of antimicrobial stewardship in the
healthcare setting
 To recognize the IDSA Guideline recommendations and
their impact on pharmacy
 To describe the role of pharmacists in antimicrobial
stewardship
 To recognize the role of the pharmacist and potential
interventions for providing optimal pharmaceutical care
while shepherding antimicrobial stewardship for the
institution
2

3. “The microbes are educated to resist penicillin and a
host of penicillin-fast organisms is bred out…In such
cases the thoughtless person playing with penicillin is
morally responsible for the death of the man who
finally succumbs to infection with the penicillin-
resistant organism. I hope this evil can be averted.”
Sir Alexander Fleming
New York Times
June 26, 1945
3

4. Timeline leading to Antimicrobial
Stewardship
1990s
1930s • MRSA is
observed in
• Sulfonamides,
penicillin and
1940s 1960s over 53% of
isolates
streptomycin obtained from
became • Staph aureus ICU patients in
available • Penicillin resistance to
resistance to a US
• Harnessing of methicillin surveillance
antibacterial Staph aureus emerges
is detected system
agents for • IDSA/SHEA
clinical use published
begins “Guidelines
for
Antimicrobial
Resistance in
Hospitals”
4

5. Present-day Issues
 Multi-drug resistance is a significant issue
resulting increased morbidity, mortality,
and healthcare costs
 In 2010, the World Health Organization
recognized antimicrobial resistance as 1 of
the 3 greatest threats to human health
 50% of antimicrobial use is inappropriate
 Recent decline in the development and
approval of newer antibacterial agents
 Increase incidence of Clostridium difficile
associated diarrhea and emergence of
resistance to treatment
5

6. “Antimicrobial resistance is a
global problem,
and antimicrobial stewardship
programs are the global solution.”
Pharmacy Practice News
August 2012
6

7. What is Antimicrobial Stewardship?
“Coordinated interventions designed to improve and
measure the appropriate use of antimicrobial agents
by promoting the selection of the optimal antimicrobial
drug regimen including dosing, duration of therapy,
and route of administration”
The Society for Healthcare Epidemiology of America (SHEA), The Infectious Diseases Society of
America (IDSA) and the Pediatric Infectious Diseases Society (PIDS)
7

8. IDSA/SHEA GUIDELINES FOR DEVELOPING AN
INSTITUTIONAL PROGRAM TO ENHANCE
ANTIMICROBIAL STEWARDSHIP
BACKGROUND CONTENTS
 Published in 2007  Executive Summary
 Developed and issued on  Introduction including the
behalf of the IDSA and purpose and methods of
SHEA guideline development
The development  Evidence- based
of effective hospital based Recommendations
stewardship programs  Members of ASP Team
All  Elements of ASPs
patients in acute care  Research and Future
hospitals Directions
8

9. Purpose of Antimicrobial
Stewardship Programs
 Goals of Antimicrobial Stewardship Programs (ASPs)
To optimize clinical outcomes while
minimizing unintended consequences of antimicrobial
use
To reduce health-care costs without
adversely impacting quality of care
 Benefits of ASPs
 Financially self-supporting
 Improve patient care
 Increases appropriateness of antimicrobial use
 Increased clinical cure
9

10. Six Essential Elements
Information Microbiology
Technology Lab
Monitoring of
Supplemental Process and
Strategies Outcome
Measurement
Effective Comprehensive
Active
Antimicrobial Multidisciplinary
Strategies Stewardship Team Approach
10

11. 1. Active Strategies
Prospective audit of Formulary restriction and
preauthorization requirements
antimicrobial use for specific agents
Should include direct
Reduces antimicrobial use and
interaction and verbal or
cost
written feedback to providers
Effectiveness of
May be facilitated through
preauthorization depends on
computer surveillance
the authorizing individual
Utilize the Pharmacy and
Shown beneficial in both large
Therapeutics Committee or
and small hospitals
equivalent group
11

12. 2. Supplemental Strategies
 Most frequently employed  Development of evidence-
intervention based practice guidelines
that incorporate local
microbiology and
 Essential to improving resistance patterns
prescribing behavior
 Facilitation of guidelines
 Will enhance and increase through education and
acceptance of stewardship feedback
strategies
12

13. 2. Supplemental Strategies
 Cycling refers to scheduled  Decrease antimicrobial
consumption
removal and substitution
of a specific antibiotic or
 Aid in utilization of developed
antibiotic class to prevent guidelines
or reverse resistance
 Example forms available on
 Insufficient data to CDC website at:
http://www.cdc.gov/getsmart
recommend routine use of /healthcare/improve-
cycling for this purpose efforts/tools.html
13

14. 2. Supplemental Strategies
 Insufficient data to  Continuing broad therapy
recommend routine use of contributes to selection of
combination therapy to
prevent resistance resistant pathogens
 Recommended Use  Recommended to use on
 Empirical therapy for the basis of culture results
critically ill patients with
MDR pathogens  Decreases antimicrobial
 Increase breadth of exposure
coverage  Substantial cost savings
 Increase likelihood of
adequate initial therapy
14

15. 2. Supplemental Strategies
 Account for patient  Benefits
characteristics, causative  Reduced length of hospital
stay
organism, infection site,  Decreased healthcare cost
and pharmacokinetic and  Reduced incident of
pharmacodynamic complications related to IV
access
characteristics of the drug
 May be facilitated by the
development of clinical
 Important component to criteria and guidelines
antimicrobial stewardship allowing conversion
15

16. 3. Information Technology
 Options  Efficient targeting of
 Computer Physician Order
Entry (CPOE) antimicrobial interventions
 Use of electronic medical
records
 Tracking of resistance
patterns
 Incorporate data based
computer-identified values
 Microbiology C&S  Identification of Nosocomial
 Hepatic and renal function Infections
 Drug-drug interactions
 Allergies
 Cost
 Identification of adverse drug
events
16

17. 4. Microbiology Laboratory
 Critical role played in antimicrobial
stewardship
 Timely identification of pathogens
 Performance of susceptibility testing
 Assists infection control efforts in
resistance surveillance
 Recommended Responsibilities
 Routine Susceptibility testing
 Resistance surveillance involvement
• Local antibiograms updated at least
annually
 Partner with infection control to
investigate local outbreaks of infection
17

18. 5. Monitoring of Process and
Outcome Measurements
• Did the intervention  Useful in determining
Process result in the desired impact of the
Measures change in program on
antimicrobial use? antimicrobial use and
resistance patterns
 Investment in data
• Did the process systems to allow for
Outcome implemented reduce evaluation as a
Measures or prevent unintended routine measure of
consequences? quality improvement
18

19. 6. Comprehensive Multidisciplinary
Antimicrobial Management Programs
 Antimicrobial stewardship requires a team approach
that incorporates each element simultaneously
 Hospital administrative support is essential
 Consensus building between administration and
providers should focus on patient safety and care
rather than policing
 These programs consistently demonstrate decrease in
antimicrobial use and hospital cost which pays for the
program
19

20. The Stewardship Team
 Infectious Diseases Physician
 Clinical Pharmacist with ID
Training
 Clinical Microbiologist
 Information System Specialist
 Infection Control Professional
 Hospital Epidemiologist
20

21. Recommended for Investigation
Validation that
Heterogeneous Long-term Impact of
Antimicrobial Cycling Antimicrobial Use Formulary Restriction
Slows Resistance and Preauthorization
Spread
Evaluation of The Ability of
Examination of
Approaches that Antimicrobials to
Strategy Efficacy in
Incorporate Many of Cause “Collateral
Subpopulations of
the Most Effective Damage” or
Hospitalized Patients
Strategies Ecological Resistance
Development and
Role of Antimicrobial
Determination of the Validation of
Stewardship
Relative Impact of Automated
Combined with
ASPs on Specific Surveillance Strategies
Infection Control
Resistant Bacteria for Nosocomial
Practices
Infections
21

22. Recommended for Investigation
Decision Support Development and Cost- Strategies to Stimulate
Systems Incorporation effectiveness of more Research and
Antimicrobial rapid and sensitive Development of Novel
Stewardship into CPOE diagnostic tests Antimicrobials
Education and Training
Influence of
of Infectious Diseases
Pharmaceutical Industry
Fellows and Pharmacists
and Representatives on
in Antimicrobial
Antimicrobial Prescribing
Stewardship
22

23. Recent Recommendations
SHEA, IDSA, PIDS April 2012
1. Antimicrobial stewardship programs should be
required through regulatory mechanisms
 Recommended that Centers for Medicare and Medicaid
Services require participating healthcare institutions
develop and implement ASPs
 CMS should improve programs by requiring additional
activities
2. Antimicrobial stewardship should be monitored in
ambulatory healthcare settings
3. Education about antimicrobial resistance and
antimicrobial stewardship must be accomplished
23

24. Recent Recommendations
SHEA, IDSA, PIDS April 2012
4. Antimicrobial use data should
be collected and readily
available for both inpatient
and outpatient settings
5. Research on antimicrobial
stewardship is needed and
should be funded by the
appropriate federal agencies
24

25. Recent Recommendations
SHEA, IDSA, PIDS April 2012
Recommended Minimum Requirements for ASPs
 Multidisciplinary team  Additional interventions
including to improve use of
 A physician antimicrobials
 A pharmacist  Processes to measure
 A clinical microbiologist and monitoring
 An infection antimicrobial use at the
preventionist institutional level
 Limited formulary  Periodic distribution of a
 Institutional guidelines facility-specific
for managing common antibiogram
infection syndromes
25

26. Pharmacist Role in Antimicrobial
Stewardship
“Pharmacists have a responsibility to take prominent
roles in antimicrobial stewardship programs and
participate in the infection prevention and control
programs of health systems”
American Society of Health-System Pharmacists
Position Statement, 2010
26

27. Responsibilities of Pharmacists
Promoting Optimal Use of
Antimicrobial Agents
Reducing Transmission of Infections
Educating Health Professionals,
Patients, and the Public
27

28. Responsibility to Promote
Optimal Use of Antimicrobials
 Encourage multidisciplinary  Work with laboratory
collaboration personnel to ensure
 Work within the P&T appropriate susceptibility
Committee, or equivalent tests are reported in a timely
structure, to ensure the manner
appropriate agents are  Work to compile and
available distribute susceptibility
reports at least annually
 Operate an ASP that utilizes
patient outcomes to assess  Utilize information
effectiveness of policies technology to enhance
stewardship through
 Generate and analyze
surveillance
quantitative data on
antimicrobial drug use to  Facilitate safe medication
perform outcome analysis management practices
28

29. Responsibility to Reduce
Transmission of Infections
 Participate in the infection  Encourage routine immunization
prevention and control of staff and those who may
committee impact the patient care
environment
 Establish internal pharmacy
 Promote adherence to standard
policies, procedures and precautions by those who
quality-control programs to impact the patient care
prevent contamination of environment
pharmacy products  Collaborate in the development
 Encourage use of single-dose of guidelines for risk assessment,
packages rather than treatment, and monitoring of
multiple-dose containers individuals in contact with a
transmissible infectious disease
 Recommend proper labeling,
dating, and storage of sterile  Strive for zero-tolerance of
products and their containers health-care associated infections
29

30. Responsibility to Educate Others
 Provide educational forums  Participate in public health
for healthcare professionals education and awareness
on stewardship-related topics programs aimed and controlling
spread of infectious disease
 Antimicrobial use and
resistance  Prudent use of antimicrobials
 Decontaminating agents  Immunization access for
children and adults
 Aseptic technique and  Appropriate infection
procedures prevention and control
 Sterilization methods measures
 Educate and counsel patients  Provide exposure to
regarding adherence to antimicrobial stewardship and
prescribed directions, storage infection prevention and control
and handling, proper disposal, practices through training for
and other infection control pharmacists, students, residents
and research fellows
procedures
30

31. Review Case
JM is an active 15 year old girl who enjoys playing
softball, swimming and running track. She was initially
presented by her mother to the ER with a temperature
of 103 and complaining of fatigue x 1 week and pain in
her hip.
During the admission her WBC counts
were normal and doctors stated there
were no signs of infection. She was
sent home with a prescription for
ibuprofen and told to follow-up in 3
days.
31

32. Review Case
Within 2 days she was brought backed to the ER as her symptoms
seemed to worsen. She was admitted and blood cultures returned
positive for Staphylococcus Aureus. JM was diagnosed with sepsis that
had begun as an abscess growing in her hip.
The infection was accompanied by many
complications including a DVT leading to PE,
and pneumonia requiring intubation.
Eventually, JM developed infections caused by
multiple MDR organisms including ESBL-
producing E. coli, S. Maltophilia, and
Enterobacter aerogenes
The only antibiotic available to treat her infections was colistin. 5
months later, after a lung transplant, suffering a stroke, and losing 30
lbs, JM was discharged home. Her entire stay totaled 6 million dollars
in healthcare costs
32

33. Questions to Consider
 What roles could antimicrobial stewardship have
played in this case...
 To prepare for such a situation prior to admission?
 To preventing nosocomial infections during admission?
 What future changes could be made to the
hospital’s policy?
 What role did or could have pharmacists played
in this case?
 Interventions
 Patient, family, or provider education
33

34. True or False Questions
1. Audits of restrictions and
formularies are
recommended by the IDSA
as key antimicrobial
stewardship activity
2. Antimicrobial stewardship is True False
the practice of using
antimicrobials appropriately
3. Antimicrobial stewardship
does not need to be
monitored in ambulatory
healthcare settings
34

35. References
 ASHP Statement on the Pharmacist’s Role in Antimicrobial Stewardship and
Infection Prevention and Control. Am J Health-Sys Pharm.2010;67:575-7.
 Dellit TH, Owens RC, McGowan JE, et al. Infectious Diseases Society of America
and the Society for Healthcare Epidemiology of America Guidelines for Developing
and Institutional Program to Enhance Antimicrobial Stewardship. Clinical
Infectious Diseases, 2007;44:159-177.
 Infectious Diseases Society of America. The 10x20 Initiative: pursuing a global
commitment to develop 10 new antibacterial drugs by 2020. Clin Infect Dis
2010;50;1081-1083.
 Goff DA, Bauer KA, Mangino JE. “Antimicrobial Stewardship Management of
Infections: Beyond the Cost of Antimicrobials”. Pharmacy Practice News.
McMahon Publishing, August 2012.
 Society for Healthcare Epidemiology of America; Infectious Diseases Society of
America; Pediatric Infectious Diseases Society. “Antimicrobial Stewardship Policy
Statement”. Infection Control and Hospital Epidemiology, April 2012; 33(4):322-327.
35