This document discusses antimicrobial stewardship programs (ASPs) and their importance in healthcare. It provides an overview of ASPs, including their goals of optimizing outcomes and minimizing resistance while reducing costs. The core elements that are required for an ASP include leadership commitment, education, antibiotic use tracking, reporting, and specific improvement interventions. Effective ASPs require multidisciplinary teams and use metrics to regularly measure antibiotic use and resistance in order to guide quality improvement efforts. Implementation of an ASP can successfully reduce rates of C. difficile infections and optimize antibiotic use in a healthcare facility.
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Understanding the ABCs of and ASP
1. Understanding the
ABCs of an ASP
Julie Rubin, Pharm.D., BCPS – CompleteRx Director of Clinical Services
Paul Green, Pharm.D., MHA, BCPS – CompleteRx Clinical Pharmacy Manager
May 24, 2017
CompleteRx Webinar Series
CE Credit: ACPE # 0523-0000-17-004-L01-P
2. Speakers
2
Julie Rubin, Pharm.D., BCPS
Director of Clinical Services
CompleteRx, Ltd
Paul Green, Pharm.D., MHA, BCPS
Clinical Pharmacy Manager
CompleteRx, Ltd
3. 3
• Recognize the relationship between antimicrobial
resistance on clinical and economic outcomes in
various patient populations
• Outline core elements required by TJC in establishing
and influencing the role of ASPs
• Describe the various metrics used to measure
antimicrobial utilization
• Recommend clinical interventions for ASPs that can be
implemented in various pharmacy practice models
3
Learning Objectives
4. 4
Disclosure
We wish to disclose that we are employees of
CompleteRx, Ltd. This presentation reflects experience
with the topics at hand. All faculty and planners report
no financial relationships relevant to this activity.
6. 6
What is Antimicrobial Stewardship?
• Coordinated interventions designed to improve and
measure the appropriate use of antimicrobials
(antibiotics, antivirals, & antifungals)
• Promote the selection of the optimal antimicrobial
• Only use antimicrobial when absolutely needed
• Use the lowest dose via the simplest route for the
shortest duration that will be clinical effective
7. 7
What is the primary goal for
implementing an ASP?
A. Save Money
B. Reduce length of stay
C. Improve patient outcomes
D. Meet accreditation standards
7
Quick Poll
8. 8
Goals of Antimicrobial Stewardship
Primary Goals:
Optimize clinical outcomes
Minimize unintended consequences of
antimicrobials
– C. diff., Resistance, Adverse reactions, etc.
Secondary Goal:
Reduce healthcare costs without
adversely impacting quality of care
1
2
9. 9
Hot Topic
Recommendations from numerous national societies and agencies
Infectious Disease Society of America (IDSA)
Centers for Disease Control and Prevention (CDC)
World Health Organization (WHO)
Society of Healthcare Epidemiology of America (SHEA)
Pediatric Infectious Disease Society (PIDS)
The Joint Commission (TJC)
Hospital Association of New York State (HANYS)
Centers for Medicare and Medicaid Services (CMS)
The White House
10. Why do we need an
Antimicrobial Stewardship
Program (ASP)?
16. 16
Why do we need an ASP?
>50% 50%
~$20B
Of all inpatients
receive an antibiotic
Of antibiotics prescribed
are unnecessary or
inappropriate
Excess healthcare cost
of antibiotic
resistance in US
17. National Action Plan for Combating
Antibiotic-Resistant Bacteria (CARB)
17
Goals: Reduce inappropriate antibiotic use by 50% in
outpatient settings and 20% in inpatient settings
18. 18
Why do we need an ASP?
• The CDC has called for all U.S. hospitals to have an ASP by the
year 2020
• As of January 1, 2017, Joint Commission (TJC) requires that
all hospitals seeking accreditation have an active ASP
• CMS is also tracking ASP actions with plans to tie real money
to ASP-related items in the near future
21. 21
Who’s on an ASP Committee?
ASP
Providers
Nursing
Executive
Leadership
IT
Respiratory
Therapy
Lab
Clinical
Education
Infection
Prevention
Quality
Pharmacy
22. Core Elements for ASPs
1. Leadership commitment from administration
2. Educating providers on use and resistance
3. Antibiotic use tracking
4. Regular reporting on antibiotic use and
resistance
5. Specific improvement interventions
23. 23
Leadership Commitment
• Formal expression of support for the
stewardship program from the facility
administration.
• Leadership must ensure that staff have
necessary time, education/competencies and
resources to implement the stewardship
program.
24. 24
Program Leadership
• Designated leader
• Physicians have proven very effective in this
role.
Prescribing is a medical staff function
Often an ID physician, but others have filled this
role, especially in hospitals with no ID physicians.
• Leadership by committee is not as effective
25. 25
Pharmacy Leadership
• Pharmacy leadership is consistently identified as a
MUST for stewardship in hospitals.
• Pharmacists often play a lead role in implementing
improvement interventions and monitoring antibiotic
use - should have training in infectious diseases.
(e.g., MAD-ID)
• Many programs are co-led by a physician and
pharmacist.
26. 26
All of the following are
part of the core elements
of ASP except:
A. Leadership commitment
B. Led by Pharmacy
C. Educate on resistance and stewardship
D. Antibiotic use tracking
26
Quick Poll
27. 27
Education and Training
Core Competencies
• Antibiotic stewardship-
the basics
• IV to PO Conversion
• Renal Dosing
• Pharmacokinetics
Advanced Training Courses
• Antimicrobial streamlining
• Developing an antibiogram
• Empiric guidelines
29. 29
Antimicrobial Stewardship Framework
Antimicrobial Formulary Restriction
Order Sets
Prospective Audit with Feedback
IV to PO Conversion
Dose Optimization
Audits & Reports
Education
Guidelines
De-escalation/Streamlining
Duration of Therapy
ACTIVEPASSIVE
BEFORE Rx AFTER Rx
Prescriber
Antibiotic
Rx
Patient
Adapted from Moehring RW et al. Curr Infect Dis Rep. 2012; 14(6): 592 – 600.
30. 30
Elements for Consideration and Prioritization
• Parenteral to oral conversion (A-I)
• When the patient’s condition allows
• Decrease length of stay
• Decrease healthcare costs
• Development of clinical criteria and guidelines
allowing conversion to use of oral agents (A-III)
31. 31
Elements for Consideration and Prioritization
• Streamlining or de-escalation therapy (A-II)
Based on culture results and elimination of redundant
therapy
Decreases antimicrobial exposure and cost
• Dose optimization (A-II)
Based on PK/PD parameters and includes patient
characteristics, causative organism, site of infection,
in addition to PK/PD characteristics of the drug
32. 32
Advantages of de-escalation
of antimicrobial therapy include:
A. Decreases inappropriate use of antimicrobials
B. Narrows antimicrobial therapy when appropriate
C. Reduces adverse events
D. Allows initial use of broad-spectrum antimicrobials
E. All of the above
32
Quick Poll
33. 33
Microbiology Stewardship
• Obtain Cultures Prior to Starting Antibiotics!
• Develop a process to ensure cultures are properly and
consistently ordered
• Develop a process to ensure cultures are properly and
consistently obtained
• Develop processes to ensure cultures are properly and
promptly transported and processed
• Develop standards for and assess reliability of processes
for ordering and obtaining a culture
34. 34
Elements for Consideration and Prioritization
• Educational programs, active intervention (A-III, B-II)
Provides foundation of knowledge
• Guidelines and clinical pathways – seek multi-
disciplinary involvement and approval (A-I)
Incorporate local antimicrobial resistance patterns (A-I)
Provide education and feedback to practitioners (A-III)
35. 35
Elements for Consideration and Prioritization
• Antimicrobial order forms (B-II)
Shown to be effective component of the program and can
facilitate implementation into practice
• Combination therapy
Insufficient data for routine use (C-II)
Has a role to increase coverage in empiric therapy in patients at risk
for multi-drug resistant pathogens
• Antimicrobial cycling – is not recommended because of
insufficient data (no ranking)
36. 36
Antibiotic Time Out
Trigger tool to stop and reassess
antibiotic therapy
Targeted at all providers for
Med/Surg patients
• Diagnosis: Does the patient have a bacterial
diagnosis that requires antibiotics?
• Drug: Do I have the right drug and dose?
(Covering the bug? Can I change to
PO/narrower spectrum?)
• Duration: How long do the guidelines
recommend treating?
• Documentation: Have I documented my plan
clearly?
37. 37
Steps in an antibiotic time out include:
A. Re-evaluating patients who received antibiotics for over 48 hrs
B. Continuing therapy for over 72 hrs if not consistent with
infection
C. Not including stop dates in MR for patients on therapy over 72
hrs
D. De-escalating therapy based on culture results for patients on
antibiotics more than 72 hrs
37
Quick Poll
39. Measurement
Clinical
•Length of stay
•Clinical cure/failure rates
•Readmission rates (30 days)
•Resistance rates
•Infection-related mortality
•C. Difficile infections
Process
•Dose optimization
•Adherence to hospital specific guidelines
•Appropriate de-escalation/streamlining
•Appropriateness of therapy
•Cultures before antibiotics
Humanistic
•Adverse drug events avoided
•Time to receipt of appropriate antimicrobials
•Duration of antimicrobial therapy
•IV/PO conversion rates
•Outpatient intravenous therapy rates
Economic
•Antimicrobial utilization (DDD or DOT)
•Hospital wide antimicrobial expenditures
•Relative consumption
•Rate of intravenous antimicrobial use
•Nonformulary agents avoided
Outcomes
DDD=Defined daily dose
DOT=Days of therapy
40. 40
Utilization - DOT and Cost
Patient Days of Therapy
• 1 DOT is the administration of at least one dose of a single
agent on a given day
• 1 DOT represents the administration of a single agent on a
given day regardless of the number of doses or strength
• Can be used in pediatrics
• Insensitive to renal function and dosage; simply one day of
exposure
• Can be adjusted to hospital census
Example: Vancomycin 1 gram every 12 hours x 5 days = 5 DOT
44. 44
Hospital-Onset C. diff. Rate
Process for Improvement
• Approval of system-wide CPOE order set
• Restriction of oral vancomycin
• Automatic therapeutic interchange
• Encourage antimicrobial streamlining
• Education in various forms to all involved parties
45. 45
Hospital-Onset C. diff. Rate
Clinical Definition Supportive Clinical Data Recommended Treatment
Initial Episode,
Mild / Moderate
WBC ≤ 15 x 103 μL
AND
SCr < 1.5 x premorbid level
Metronidazole 500 mg PO TID x 10 days
Initial Episode,
Severe
WBC > 15 x 103 μL
OR
SCr > 1.5 x premorbid level
Vancomycin 125 mg PO QID x 10 days
Initial Episode,
Severe / Complicated
Meets criteria for severe initial episode
AND
Hypotension / shock, ileus, or megacolon
Metronidazole 500 mg IV TID
PLUS
Vancomycin 500 mg PO QID
x 10 days
(If ileus, may consider PR vancomycin)
1st Recurrence - Same as Initial Episode
> 1st Recurrence -
Vancomycin 125 mg PO QID x 14 days
THEN
“Taper & Pulse” with Vancomycin 125 mg PO
BID x 7 days
FOLLOWED BY
Vancomycin 125 mg QOD x 6 weeks
48. 48
Key Takeaways
• CMS and TJC are developing guidance for
accreditation related to demonstrating an effective
ASP, including developing publicly reportable
measures
• Antimicrobial resistance is an urgent public health
and patient safety concern
• Know your local epidemiology
• All stakeholders need to be engaged across the
continuum of care, including consumers
CMS=Centers for Medicare and Medicaid Services
TJC=The Joint Commission