32nd Annual APIC Palmetto Educational Conference
Critical Antimicrobial Stewardship
Program Components for Success
Julie Ann Justo, PharmD, MS, BCPS, AAHIVP
Assistant Professor, South Carolina College of Pharmacy
ID Clinical Specialist, Palmetto Health Richland
October 24, 2014
Disclosure
• Prior: Cubist Pharmaceuticals
• Grant/Research Support for antimicrobial stewardship
Objectives
• List the essential goals and team members of an
antimicrobial stewardship program (ASP)
• Describe the key components to consider during the
development of an ASP initiative in the hospital
setting
• Provide examples of successful ASP initiatives
Essential Stewardship Ingredients:
Goal & Core Team Members
Antimicrobial Stewardship
• Goal: Optimize clinical outcomes and minimize
unintended consequences of antimicrobial use
• Example of interpretation for local ASP goals:
1. Improvement in quality of patient care
2. Minimize toxicity from antimicrobial therapy
3. Reduce antimicrobial resistance
4. Reduce cost of antimicrobial therapy
1. Dellit TH, et al. Clin Infect Dis 2007; 44: 159-177.
What Antimicrobial Stewardship is Not…
1. Yates RR. Chest 1999; 115: 24S-27S.
Antimicrobial Stewardship Core Team
Infectious
Diseases (ID)
Physician*
• Share goals such as
minimizing
antimicrobial
resistance
• Expert in initiative
development
Infection
Control
Professional
• Liaison for dual
initiatives
• Expert in analyzing
population-level data
• Support research
study design &
outcomes reporting
Clinical
Microbiologist
• Compile raw isolate &
susceptibility data
• Implement micro-driven
initiatives
Antimicrobial
Stewardship
Core Team
Information
System
Specialist
Hospital
Epidemiologist
ID Clinical
Pharmacist*
*A-II recommendation, others are A-III
1. Dellit TH, et al. Clin Infect Dis 2007; 44: 159-177.
• Design & integrate
clinical decision support
systems
• Ensure patient- and
population-level data
interface across systems
Antimicrobial Stewardship
• Other key stakeholders:
• Hospital Administration
•
•
•
Provide infrastructure
Ensure adequate authority and compensation for AS core
Negotiate defined, measurable outcomes
• Medical Staff Leadership/Local Providers
•
•
Early buy-in with ASP development
Assist with maintenance
• Pharmacy and Therapeutics Committee
•
Essential for formulary restriction and guideline initiatives
• ASPs often reside in quality assurance or patient
safety departments
1. Dellit TH, et al. Clin Infect Dis 2007; 44: 159-177.
Antimicrobial Stewardship & Support Team (ASST):
A Local Hospital Experience
Full ASST Committee
•
•
1 ID Physician,
Director
•
•
1 Clinical
Informatics
Specialist
ASST Core
1 Senior
Clinical
Microbiology
Technician
•
•
•
4 ID Clinical
Pharmacists
(2 faculty, 2
hospital
employees)
•
•
ASST Core
Infection Control/Hospital
Epidemiologist (ID physician),
Infection Control Manager
Microbiology Lab Director
Physician representation from
Surgery, Hospitalists,
Intensivists
Pharmacy administration
Nursing administration, Nurse
Practitioners
Pediatric ASP Team (2 ID
physicians, 2 ID clinical
pharmacists)
IT System Analysts
Representation from all
campuses
Antimicrobial Stewardship
• Infectious Diseases Society of America and Society of
Healthcare Epidemiology of America (IDSA/SHEA)
guidelines for developing AS programs specifically
comment on technology:
“Health care information technology in the form of
electronic medical records (A-III), computer physician order
entry (B-II), and clinical decision support (B-II) can improve
antimicrobial decisions through the incorporation of
[patient-specific] data...”
1. Dellit TH, et al. Clin Infect Dis 2007; 44: 159-177.
The Stewardship Geek Squad
Antimicrobial
Stewardship
Core Team
Clinical
Informatics
Information
Technology
1. http://www.acphospitalist.org/archives/2009/01/cover_sm.jpg
2. http://www.healthcare-informatics.com/sites/healthcareinformatics.com/files/imagecache/100x100/DoctorNurseLaptop_13033843_SMALLER.jpg
3. http://www.webster.edu/images/technology/desktop-pc.jpg
Information System Specialists
• Pr
Information Technology (IT) Specialist
• Primarily concerned with application of technology, i.e. computer
science
• Operational IT: Computers, servers, email, electronic medical record
• Research IT: Clinical data warehouse
• “Help! Make it go…”
Biomedical (Clinical) Informatics Specialist
• Primarily concerned with storage, retrieval, and optimum use of
data, information, and knowledge for problem solving and decisionmaking
• View computers as tools for manipulating information
• Key expertise is to improve connectivity between patient data and
knowledge in order to aid in clinical decision-making
• Computer savvy ≠ IT support!
1. Bernstam EV, et al. Acad Med 2009; 84: 964-970.
Interdisciplinary Effort
• Determines
the
destination
Antimicrobial
Stewardship
Clinical
Informatics
• Charts the
course
• Steers the
ship
Information
Technology
Or…
I thought you knew how
to drive!
I thought you knew
how to navigate!
ASP
I didn’t know we were
going off-road!
CI
http://rogerkramercycling.org/blog/wp-content/uploads/2012/04/stoogebike.jpg
IT
Developing Hospital Antimicrobial
Stewardship Initiatives:
Key Components
Key Components for ASP Initiatives
• What to do?...
Problem Identification &
Strategy Development
• Who will do it?... Engaging Clinicians
• How to do it?...
Technology
• Why do it?...
Outcomes Evaluation
Key Components for ASP Initiatives
• What to do?...
Problem Identification &
Strategy Development
• Who will do it?... Engaging Clinicians
• How to do it?...
Technology
• Why do it?...
Outcomes Evaluation
Problem Identification
• Start with the mission statement
• Example: Local ASST Goals
1. Improvement in quality of patient care
2. Minimize toxicity from antimicrobial therapy
3. Reduce antimicrobial resistance
4. Reduce cost of antimicrobial therapy
• Data is your best friend!
• Target problems with a high likelihood of success
• When in doubt, just start somewhere…
Common ASP Initiative Strategies
Prospective
Audit
Optimal
Antimicrobial
Use
• Interaction and Feedback
Formulary
Restriction
Other Strategies
1. Dellit TH, et al. Clin Infect Dis 2007; 44: 159-177.
• Prior Authorization
•
•
•
•
•
•
•
Guidelines and clinical pathways
Antimicrobial cycling
Antimicrobial order forms
Combination therapy
Streamlining or de-escalation of therapy
IV to PO conversion
Dose optimization
• Pharmacokinetic/therapeutic drug
monitoring
Prospective Audit & Feedback
•
ASP members “audit” patient charts on pre-determined,
targeted patient list
•
Time-intensive  Should balance quantity and quality
•
•
•
Focus on patients/events with high return on investment
Lists highly institution-specific
Examples: high-cost antimicrobials, positive blood cultures, bug-drug
mismatches
•
Ensure complete, efficient, and feasible patient identification
(CI and IT very helpful here)
•
Baseline and ongoing data collection
•
•
Interventions & Outcomes
Specific-items often edited/cycled as institution’s needs
evolve
Formulary Restriction & Preauthorization
•
Several options to guide antimicrobial use
•
•
•
•
Prior Auth.: Consider hours of operation & staffing
•
•
Off-hours protocol? On-call service needed? Compensation?
Patient/event identification also crucial here
•
•
Formulary removal (or addition)
Prior authorization by ASP (or other authorized member)
Pre-approved indications
Pager? Email? Phone call from pharmacy? iPhone app?
Baseline and ongoing data collection
•
Consider trial periods/locations with pre-post evaluation
•
•
Trial period allows comparison across time (Off-On-Off)
Trial units or services allows comparison to control group
The Ultimate ASP Strategy
• All strategies should incorporate education!
• This is the “Support” in ASST
• Multiple resources at local institution
•
•
•
Pocket Antimicrobial Guidebook (antibiogram, guidelines, dosing)
Website (ASST initiatives, contact info, electronic documents)
Medicine & Pharmacy Grand Rounds, Noon Conference, etc.
A Local ASST Experience
Formulary Restriction
Prospective Audit & Feedback
Pre-Approved Indications
All Pre-Approved/Prior Authorizations
Daptomycin
Carbapenem Use > 48 hours
Linezolid
Positive Blood Cultures
Polymyxin B/Colistimethate sodium
**Safety Surveillor® (Premier, Inc.)
Carbapenems (pending)
MDROs (e.g., VRE, ESBLs, CREs)
**Electronic chart note approved for use by
Prior Authorization
AsMEC.
time allows:
P&T and
Fidaxomicin
Positive
Cultures
**Required
MEC Urine
change
to allow PharmD.
Ceftaroline
Positive Respiratory Cultures
Tigecycline
Triple antibiotic therapy > 72 hours
Vanc/Pip-tazo > 48 hours
•
Other ASST initiatives
•
•
•
•
•
Antimicrobial allergy reconciliation (mainly beta-lactams)
Antiretroviral inpatient service
Indication-specific guidelines (e.g., gram-negative bacteremia)
Drug-specific guidelines (e.g., vancomycin)
IV to PO switch
Key Components for ASP Initiatives
• What to do?...
Problem Identification &
Strategy Development
• Who will do it?... Engaging Clinicians
• How to do it?...
Technology
• Why do it?...
Outcomes Evaluation
ASP Communication & Documentation
• Direct ASP contact with prescriber
•
•
•
Typically ID Clinical Pharmacist
Phone, face-to-face
Attend rounds
• ASP note in chart (electronic vs. paper)
•
Permanent vs. temporary
• Forms committee? Ability of personnel to leave notes?
•
Liability with recommendations
• Many physicians prefer documentation of
recommendations in the chart
ASST
Prescriber
Extensions of ASP Communication
• Indirect ASP contact with prescriber
• Utilize other key healthcare personnel
•
•
•
•
Pharmacists
Nursing
Microbiology Technicians
…Create culture of, “Everyone is a steward.”
• Utilize technology
• Before Rx signed at the point of CPOE
• After Rx signed to provide electronic feedback
• …Achieved through Clinical Decision Support Systems
Key Components for ASP Initiatives
• What to do?...
Problem Identification &
Strategy Development
• Who will do it?... Engaging Clinicians
• How to do it?...
Technology
• Why do it?...
Outcomes Evaluation
Clinical Decision Support Systems
• Example of applied clinical informatics
Evidence-based
Practices
Patient Data
Clinician
…at the point of care
Features of a Successful Clinical
Decision Support System (CDSS)
1. Makes clinician’s job easier
2. Includes educational component (providing
literature and important caveats) to foster user
acceptance
3. Delivers patient-specific, pertinent data
•
5 W’s: Who to see? What data? What action? Why act?
What to document?
4. Operates in real-time
1. Pestotnik SL, et al. Pharmacotherapy 2005; 25(8): 1116-1125.
Features of a Successful Clinical
Decision Support System (CDSS)
5. Provides online feedback and documentation
within the application
6. Offers evidence-based clinical recommendations
(emphasis on choice)
7. Fulfills the 6 generic uses:
•
Alerting, interpreting, assisting, critiquing, diagnosing,
and managing decision support
8. Adheres to standards for clinical terminology
1. Pestotnik SL, et al. Pharmacotherapy 2005; 25(8): 1116-1125.
Third-Party CDSSs Focusing on
Antimicrobial Stewardship
Software
Vendor
TheraDoc
Hospira Inc.
Safety Surveillor
Premier Inc.
MedMined
CareFusion
QC PathFinder
Vecna
Sentri7
Pharmacy OneSource Inc.
Allscripts
Allscripts
McKesson
McKesson
1. Kullar R, et al. Clin Infect Dis 2013; 57: 1005-1013.
Logo
Advantages of CDSSs
• Most are designed to interface with electronic
medical records (EMRs), e.g. EPIC and Cerner
• Generally have greater capacity for AS-specific
activities than the EMR alone
• Alerts
• Reports
• Targeted Patient Lists
• Provide combined data that is typically unavailable
without significant daily time and effort
• Cultures and susceptibilities, current antimicrobial
regimens, hepatic and renal function, allergies, etc.
Real-Time Alerts and Reporting
• Local ASST experience with Safety Surveillor®
(Premier, Inc.)
•
Sample of targeted patient list by drug usage:
Barriers to Implementation &
Effectiveness of CDSSs 1,2
• Cost
• $100,000 - $500,000 per year per institution
• Time to implementation
• Committee approval, e.g. Pharmacy & Therapeutics
• Waiting in the IT “queue” or task list
• Time for maintenance
• Updates to formulary, clinical practice guidelines, etc.
• Informatics specialists for more advanced algorithms
• Integration into clinical workflow
• Alert fatigue
1.
Kullar R, et al. Clin Infect Dis 2013; 57: 1005-1013.;
2. Njoku JC and Hermsen ED. J Pharm Pract 2010; 23: 50-60.
CDSS Implementation for AS
• Pre-/post study evaluating TheraDoc implementation at the
Nebraska Medical Center1
• 8 alert types utilized, including:
• Polyantibacterials, redundant anaerobic coverage, drug-bug
mismatch, vancomycin for CONS or MSSA, no positive cultures
• Of 10,545 alerts, only 30% were actionable overall
• Significant increase in interventions in the
postimplementation period
• ASP made interventions on 75-92% of actionable alerts
• Decentralized pharmacists made interventions on 12% of
actionable alerts
• Overall acceptance rate: 88%
1. Hermsen ED, et al. Infect Control Hosp Epidemiol 2009; 84: 964-970.
CDSSs within the EMR
• Tools within EPIC:
1. iVents
2. 96-Hour Stop Date
3. IV-to-PO Interchange
4. Antibiotic Order Forms and Dose Checking Alerts
5. Navigator and Best Practice Alerts
6. Patient Scoring and Monitoring
1. Kullar R, et al. Clin Infect Dis 2013; 57: 1005-1013.
Antibiotic Order Forms
• Required fields for each order, assists in education and
research
• Stewardship at the point of order verification
1. Kullar TH, et al. Clin Infect Dis 2007; 44: 159-177.
Navigator and Best Practice Alerts
• ASP recommendations made as a Best Practice Alert
• Published evidence provided at the point of care
1. Kullar TH, et al. Clin Infect Dis 2007; 44: 159-177.
CDSSs within the EMR
• Tools within Cerner:
1. Formulary Restriction and Preauthorization
A. Criteria Monitored Drugs
B. Special Instructions Approval
2. Prospective Audit and Feedback
A. InfoView Reports
B. mPages
3. Additional Strategies
A.
B.
C.
D.
Ordersets and PowerPlans
Antibiotic Indications Field
Dose Range Checks
Promoting Education through Toolbars
1. Pogue JM, et al. Clin Infect Dis 2014; 59: 416-424.
Cerner Tools
• Special Instructions Approval
1. Pogue JM, et al. Clin Infect Dis 2014; 59: 416-424.
Cerner Tools
• Educational
Toolbars
1. Pogue JM, et al. Clin Infect Dis 2014; 59: 416-424.
Rapid Diagnostic Tests
• Novel tests that can
significantly ↓ time
to:
• Organism
identification
• Susceptibility
testing data
• Examples:
•
•
•
•
1.
PNA FISH
MALDI-TOF
PCR
Nucleic acid
Goff DA, et al. Pharmacotherapy 2012; 32: 677-687.
PNA FISH
• Yeast Traffic Light PNA FISH
1.
2.
http://www.advandx.com/AdvanDX/media/Downloads/Assay%20Overviews/YTL-PNA-FISH-Overview.png
http://www.advandx.com/products/pna-fish-tests/yeast-traffic-light
MALDI-TOF MS
• Analyzes
25,000 spectra
in database
• Results in
minutes
http://www.laboratorytalk.com/pictures/633xAny/2/7/2/3272_VITEK.jpg
Key Components for ASP Initiatives
• What to do?...
Problem Identification &
Strategy Development
• Who will do it?... Engaging Clinicians
• How to do it?...
Technology
• Why do it?...
Outcomes Evaluation
Outcome Measures
•
Antimicrobial usage
•
•
Cost avoidance/savings
•
•
Antibiogram trends
HospitaI-acquired infection rates
•
•
•
Antimicrobials, laboratory, hospitalizations
Resistance patterns
•
•
Days of Therapy (DOT), Defined Daily Doses (DDD)
C. difficile-associated diarrhea
Multidrug-resistant organisms, or MDROs
Clinical endpoints
• Mortality, length of stay
Outcomes with MALDI-TOF & ASP in
Bloodstream Infections (BSIs)
• Pre-post quasi-experimental study at University of Michigan
Hospitals and Health System
• Evaluated clinical outcomes in 501 adult patients with BSIs
over 3-month periods before and after intervention
• Intervention:
• MALDI-TOF identification (ID) reported 6:00am-11:30pm
•
Blood subcultured and incubated overnight prior to analysis
• ASP activities
•
•
Real-time alerts for (+) blood cultures via TheraDoc
Recommendations according to local guidelines at time of (1)
Gram stain, (2) organism ID, and (3) susceptibility testing results
1. Huang AM, et al. Clin Infect Dis 2013; 57: 1237-1245.
Outcomes with MALDI-TOF & ASP in
Bloodstream Infections (BSIs)
• Intervention showed significant ↓ in time to:
• Organism ID (55.9 vs. 84.0 h, p<0.001)
• Effective therapy (20.4 vs. 30.1 h, p=0.021)
• Optimal therapy (47.3 vs. 90.3 h, p< 0.001)
1. Huang AM, et al. Clin Infect Dis 2013; 57: 1237-1245.
Outcomes with MALDI-TOF & ASP in
Bloodstream Infections (BSIs)
• Intervention also showed
significant ↓ in:
• 30-day all-cause mortality
(12.7% vs. 20.3%, p=0.021)
• Length of ICU stay
(8.3 vs. 14.9 d, p=0.014)
• Recurrence of same BSI
(2.0% vs. 5.9%, p=0.038)
1. Huang AM, et al. Clin Infect Dis 2013; 57: 1237-1245.
Local ASST Case: Daptomycin
•
Early local ASST initiative
•
Curbing overuse expected to address ALL of the ASST goals
•
215 courses of therapy in 2011-2012
• ~69% inappropriate use (e.g., MRSA without reason, VRE in urine)
One of the top local drug expenditures ($283,656 in FY
2012)
Total Daptomycin Expenditures FY 2012
$60,000
$40,000
$20,000
Oct-12
Aug-12
Jun-12
Apr-12
Feb-12
Dec-11
$0
Oct-11
•
Local ASST Case: Daptomycin
•
2011-2012: Fosfomycin E-testing on urinary VRE isolates
•
Oct-Nov 2012: Fosfomycin added to formulary; Prospective
audit of VRE(+) urine cultures
•
May 2013: Daptomycin ordering restricted to PowerPlan
•
Required selection of a pre-approved indication
1. Staphylococcus aureus with high vancomycin MIC ( > 2 mcg/mL)
2. Vancomycin-resistant Enterococcus (VRE) from non-urinary source
3. Documented vancomycin allergy, NOT Red Man’s Syndrome
4. Vancomycin therapy failure (Consider ID consult)
5. Other indication: ASST prior approval required (off-hours ordering
reviewed the next business day)
Local ASST Case: Daptomycin
• Daptomycin PowerPlan
•
CPK monitoring included in PowerPlan
Local ASST Case: Daptomycin
FY 2012 $283,656
FY 2013 $163,266
FY 2014 $145,969
Total Daptomycin Expenditure FY 2012-2014
$60,000.00
Fosfomycin on-formulary &
VRE urine audits, 10-11/12
$50,000.00
2 patients on
6+ weeks of dapto
Daptomycin PowerPlan, 5/13
$40,000.00
$30,000.00
$20,000.00
$10,000.00
FY 2012
FY 2013
FY 2014
Aug-14
Jun-14
Apr-14
Feb-14
Dec-13
Oct-13
Aug-13
Jun-13
Apr-13
Feb-13
Dec-12
Oct-12
Aug-12
Jun-12
Apr-12
Feb-12
Dec-11
Oct-11
$0.00
Local ASST Case: Carbapenems
• Carbapenem overuse a significant problem
•
•
•
Utilization rates high (internal data from the institution)
Risk factor for infections due to carbapenem-resistant
Enterobacteriaceae (CREs)1,2
Risk factor for C. difficile infections (internal data)
• ASST Initiatives
•
Jul 2013: Prospective audit of carbapenem use > 48 hours
•
•
•
•
Inappropriate Use: De-escalation or discontinuation
Appropriate Use: Stop date suggested, dose optimization
Beta-lactam allergy reconciliation
Jan 2014: Gram-negative Bloodstream Infection Management
• Local guidelines published
• Prospective audit of positive blood cultures initiated
• MALDI-TOF initiated
1. Hussein, et al. Infect Control Hosp Epidemiol 2009; 30: 666-671.
2. Falagas , et al. J Antimicrob Chemother 2007; 27: 1124-1130.
GN BSI
No carbapenems first-line
Local ASST Case: Carbapenems
ASST Carbapenem Interventions
Oct 2013-Dec 2013
12
2
21
D/C Carbapenem
7
D/C Other agent
De-escalation/Streamline
9
Dosage/Duration Rec
Stop date
Other
58
Acceptance Rate: 82% (93/113)
Local ASST Case: Carbapenems
Meropenem
shortage
Audit of >48h
carbapenem
GN BSI Guideline
& Audit
DOT per 1000 patients-days
40
35
30
25
Total
20
15
Meropenem
10
Imipenem
5
Ertapenem
0
Time period
Local ASST Case: Carbapenems
18
Audit of >48h
carbapenem
14
GN BSI Guideline
& Audit
12
8
4.1
2
4.2
4
9.7
6
8.1
16.1
10
5.8
CRE incidence rate per
100,000 patient-days
16
0
Time period
Local ASST Case: Carbapenems
• Future strategies pending implementation
• Cerner Tools: Antibiotics Indications Field
Summary
• Optimal antimicrobial use is the ultimate goal
• Effective stewardship teams are interdisciplinary,
including CI and IT
• Key components to consider for hospital ASP
initiatives:
• (1) Problem & Strategy, (2) Clinician Engagement,
(3) Technology, and (4) Outcomes Evaluation
• Many examples of successful ASP initiatives exist
• Growing number utilize innovative tools, e.g.,
clinical decision support and rapid diagnostic tests
Acknowledgments
Antimicrobial Stewardship and Support Team
(ASST)
Majdi Al-Hasan, MBBS
ASST Director
Palmetto Health
Richland
Joseph Kohn, PharmD, BCPS
Palmetto Health
Baptist & Parkridge
Katie DeVaul, PharmD
P. Brandon Bookstaver,
PharmD, BCPS (AQ-ID), AAHIVP
Julie Ann Justo, PharmD, MS,
BCPS, AAHIVP
…And the rest of the PH ASST Team!
32nd Annual APIC Palmetto Educational Conference
Critical Antimicrobial Stewardship
Program Components for Success
Julie Ann Justo, PharmD, MS, BCPS, AAHIVP
Assistant Professor, South Carolina College of Pharmacy
ID Clinical Specialist, Palmetto Health Richland
October 24, 2014
justoj@sccp.sc.edu