©2011 MFMER | slide-1 Antimicrobial Stewardship Regulations, Standards and Elements Sarah R. Lessard, PharmD, BCPS Pharmacy Grand Rounds Tuesday, November 29, 2016 Mayo Clinic Health System Franciscan Healthcare – La Crosse, WI
©2011 MFMER | slide-1
Antimicrobial StewardshipRegulations, Standards and Elements
Sarah R. Lessard, PharmD, BCPS
Pharmacy Grand RoundsTuesday, November 29, 2016
Mayo Clinic Health System Franciscan Healthcare – La Crosse, WI
©2011 MFMER | slide-2
Reuters Health News. Scarce resources, climate biggest threats to world health. 07/27/11. Copyright 2016 Reuters. Available at: http://www.reuters.com/article/us-climate-health-
idUSTRE79G4VP20111017, accessed 10/16/16
A. Srinivasan. CDC Expert Commentary. Three Steps to Antibiotic Stewardship. Medscape 2010. Available at: http://www.medscape.com/viewarticle/731784, accessed 10/16/16
A. Trivedi K, Dumartin C, Gilchrist M, Wade P, Howard P. Identifying best practices across three countries: hospital antimicrobial stewardship in the United Kingdom, France, and the United
States. Clin Infect Dis. 2014;59(S3):S170–8
Images labeled for reuse. Images.google.com
$1,100,000,000
$4,300,000 $3,300,000
$357,496 $285,076
$1
$100,000,000
Unnecessaryantibiotic
prescriptions forupper respiratoryinfection in adults
Redundantantimicrobial therapy
Redundant anti-anaerobic therapy
Redundant anti-MRSA therapy
(Vanco-Linezolid)
Redundant anti-MRSA therapy(Vanco-Dapto)
Antibiotic Overuse
©2011 MFMER | slide-3
CDC. Appropriate Antibiotic Use – Saves lives, saves money, makes sense.
Available at : http://www.cdc.gov/getsmart/healthcare/resources/factsheets/pdf/antibiotic-use.pdf, accessed 10/16/16
Infect Control Hosp Epidemiol 2014;35(10):1229-1235
Vanco = vancomycin
Dapto = daptomycin
©2011 MFMER | slide-4
CDC. Appropriate Antibiotic Use – Saves lives, saves money, makes sense.
Available at : http://www.cdc.gov/getsmart/healthcare/resources/factsheets/pdf/antibiotic-use.pdf, accessed 10/16/16
Objectives
• Identify regulatory bodies that are implementing standards of practice for antimicrobial stewardship.
• List 3 of the 8 elements of performance for the Joint Commission standard for antimicrobial stewardship.
• Recognize the relationship between the CDC’s Core Elements, the Joint Commission standard and pending CMS requirements for participation for antimicrobial stewardship.
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Historical Perspective: CDC
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• Get Smart Campaign
• Get Smart About Antibiotics (Nov 14-20, 2016)
1995
• Antimicrobial Resistance Threat Report
2013• AS Core
Elements (Hospital)
2014
• AS Core Elements (Nursing Homes)
2015• AS Core
Elements (Outpatient)
2016
CDC. Get Smart Programs and Observances. Available at: http://www.cdc.gov/getsmart/index.html
CDC. Antibiotic Resistance Threats in the United States. Available at: http://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf
•CDC. Core Elements of Hospital Antibiotic Stewardship Programs. Available at http://www.cdc.gov/getsmart/healthcare/pdfs/core-elements.pdf
CDC. The Core Elements of Antibiotic Stewardship for Nursing Homes. Available at: http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship.pdf
CDC. The Core Elements of Outpatient Antibiotic Stewardship. Available at: https://www.cdc.gov/getsmart/community/pdfs/16_268900-a_coreelementsoutpatient_508.pdf
CDC = Centers for Disease Control and Prevention
AS = antimicrobial stewardship program
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Leadership Commitment
Accountability
Drug Expertise
Action
Tracking
Reporting
Education
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/pdfs/core-elements.pdf
CDC Core Elements: Hospital Antibiotic Stewardship Programs
U.S. Acute Care HospitalsImplementation of Core ElementsNational Healthcare Safety Network 2014
©2011 MFMER | slide-8
CDC Core
Element Example Percent
All 7 Core Elements implemented 39
Leadership
commitment
Salary support 32
Accountability Point person 72
Drug expertise At least 1 pharmacist responsible for improving
antibiotic use
87
Action Prospective audit with feedback 74
Tracking Monitor antibiotic utilization 69
Reporting Feedback to providers 59
Education Education provided to clinicians and other
relevant staff
62
Pollack LA, van Santen KL, Weiner LM, et al. Antibiotic Stewardship Programs in U.S. Acute Care Hospitals: Findings From the 2014 National Healthcare
Safety Network Annual Hospital Survey. Clin Infect Dis 2016 63: 443-449
U.S. Acute Care HospitalsImplementation of Core ElementsNational Healthcare Safety Network 2014
©2011 MFMER | slide-9
CDC Core
Element Example Percent
All 7 Core Elements implemented 39
Leadership
commitment
Salary support 32
Accountability Point person 72
Drug expertise At least 1 pharmacist responsible for improving
antibiotic use
87
Action Prospective audit with feedback 74
Tracking Monitor antibiotic utilization 69
Reporting Feedback to providers 59
Education Education provided to clinicians and other
relevant staff
62
Pollack LA, van Santen KL, Weiner LM, et al. Antibiotic Stewardship Programs in U.S. Acute Care Hospitals: Findings From the 2014 National Healthcare
Safety Network Annual Hospital Survey. Clin Infect Dis 2016 63: 443-449
Facility teaching status
Written support from administration
Salary support
Wisconsin Acute Care HospitalsImplementation of Core Elements
0
10
20
30
40
50
60
70
80
90
100
Leadershipcommitment
Accountability Drug expertise Action Tracking Reporting Education
(%)
U.S. 2014 Wisconsin 2014 Wisconsin 2015
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Pollack LA, van Santen KL, Weiner LM, et al. Antibiotic Stewardship Programs in U.S. Acute Care Hospitals: Findings From the 2014 National Healthcare
Safety Network Annual Hospital Survey. Clin Infect Dis 2016 63: 443-449
WHA and MetaStar. Antimicrobial Stewardship Webinar. May 19, 2016
Historical Perspective: JC and CMS
JC
• National Hospital Inpatient Quality Measures (Core Measures)
• Immunizations
• Severe sepsis and septic shock
• Pneumonia (retired)
• Surgical Care Improvement Project (retired)
• National Patient Safety Goals• Health care-associated infections due to
MDROs
• CLABSI
• CAUTI
• SSI
CMS
• Hospital Inpatient Quality Reporting (IQR) Program
• 2012: Pneumonia (immunizations)
• 2015: CAUTI, CLABSI
• 2016: CAUTI, CLABSI, SSI (colon surgery/abdominal hysterectomy)
• 2017: CAUTI, CLABSI, SSI (colon surgery/abdominal hysterectomy), MRSA bacteremia, C. difficle infections
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Joint Commission. Specifications Manual for National Hospital Inpatient Quality Measures.
Available at: https://www.jointcommission.org/specifications_manual_for_national_hospital_inpatient_quality_measures.aspx /
CMS. Readmissions Reduction Program (HRRP).
Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html
CMS. Hospital-Acquired Condition Reduction Program (HACRP).
Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/HAC-Reduction-Program.html
CAUTI = catheter associated urinary tract infections
CLABSI = central line-associated bloodstream infections
CMS = Centers for Medicare & Medicaid Services
JC = Joint Commission
MDRO = multidrug resistant organisms
MRSA = methicillin resistant Staphylococcus aureus
SSI = surgical site infections
Historical Perspective: VA
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Department of Veterans Affairs. VHS Directive 1031. Jan 2014
Image labeled as ‘Creative Commons’ for reuse, Bing.com
VA = Department of Veterans Affairs
Historical Perspective: California
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California Department of Public Health. The California Antimicrobial Stewardship Program Initiative. Available at:
http://www.cdph.ca.gov/programs/hai/Pages/AntimicrobialStewardshipProgramInitiative.aspx, accessed 10/16/16
Johnson LS, MacDougall C, Triveldi KK. Curr Treat Options Infect Dis (2016) 8:93–101
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2008
• Monitor antibiotics (acute care)
2010
• California ASP Initiative (acute care)
2014
• Adopt ASP policy (acute care)
2017
• Adopt ASP (skilled nursing facilities)
ASP = antimicrobial stewardship program
Historical Perspective: International
United Kingdom France United States
Number of
hospitals2412 ~2500 ~5723
Legislation 2008 20022007: financial penalties
Executive Order 2014….
InfrastructureInfection specialists,
pharmacists
Physician, pharmacist,
microbiologist, or infection
preventionist
Physician, pharmacist
Strategies
Guidelines, IV-to-PO, de-
escalation, dose
optimization, audits,
education, training
Guidelines, restricted
antibiotics, audits,
education, feedback to
prescribers
Varies
OutcomesAntimicrobial utilization,
compliance with
algorithms
Antimicrobial utilization,
compliance with
algorithms
Antimicrobial
expenditures,
antimicrobial susceptibility
patterns, C. difficile
infection rates
©2011 MFMER | slide-14
Trivedi K, Dumartin C, Gilchrist M, Wade P, Howard P. Identifying best practices across three countries: hospital antimicrobial stewardship in the
United Kingdom, France, and the United States. Clin Infect Dis. 2014;59(S3):S170–8.
Executive OrderCombating Antibiotic Resistant Bacteria
Executive Order:
Combating Antibiotic Resistant Bacteria
(Sept 2014)
Task ForceAction Plan
(March 2015)
Antibiotic Stewardship
Forum
(June 2015)
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Abramowitz P. White House Forum on Antibiotic Stewardship. Available at: http://connect.ashp.org/blogs/paul-abramowitz/2015/06/03/white-house-forum-on-
antibiotic-stewardship?ssopc=1, accessed 5/28/16
The White House Office of the Press Secretary. Executive Order -- Combating Antibiotic-Resistant Bacteria. Available at: https://www.whitehouse.gov/the-press-
office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria, accessed 10/16/16
The White House. National Action Plan for Combating Antibiotic Resistant Bacteria. 2015. Available at:
https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf, accessed 10/16/16.
National Action Plan Combating Antibiotic Resistant Bacteria
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Abramowitz P. White House Forum on Antibiotic Stewardship. Available at: http://connect.ashp.org/blogs/paul-abramowitz/2015/06/03/white-house-forum-on-
antibiotic-stewardship?ssopc=1, accessed 5/28/16
The White House Office of the Press Secretary. Executive Order -- Combating Antibiotic-Resistant Bacteria. Available at: https://www.whitehouse.gov/the-press-
office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria, accessed 10/16/16
The White House. National Action Plan for Combating Antibiotic Resistant Bacteria. 2015. Available at:
https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf, accessed 10/16/16.
Slow the emergence of resistant bacteria and prevent the spread of resistant infections
Strengthen national ‘One-Health’ surveillance efforts to combat resistance
Advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria
Accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines
Improve international collaboration and capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development
National Antimicrobial Stewardship Action
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2014
• VA Directive
• Executive Order for Combating Antibiotic Resistant Bacteria
2015
• National Action Plan for Combating Antibiotic Resistant Bacteria
2017-18
• Joint Commission ASP
• *CMS ASP
2020
• All States implement ASP
ASP = antimicrobial stewardship program
CMS = Centers for Medicare & Medicaid Services
VA = Veteran Affairs
*Confirmation pending
Joint Commission Antimicrobial Stewardship Standard
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Leadership commitment
Staff education
Patient and family
education
Multi-disciplinary
team
Core Elements
Multi-disciplinary protocols
Collect, analyze, and report data
Joint Commission Perspectives®. Approved: New antimicrobial stewardship standard. Copyright 2016 The Joint Commission. July 2016, Volume 36(7)
Action
MM.09.01.01
Assessment Question #1
• Beginning January 1, 2017, the Joint Commission requirements for antimicrobial stewardship go into effect but no other regulatory bodies are expected to implement antimicrobial stewardship requirements in 2017.
• True
• False
©2011 MFMER | slide-19
Assessment Question #1
• Beginning January 1, 2017, the Joint Commission requirements for antimicrobial stewardship go into effect but no other regulatory bodies are expected to implement antimicrobial stewardship requirements in 2017.
• True
• False
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Assessment Question #2
• The Joint Commission antimicrobial stewardship standard elements of performance include:
• A: Leadership commitment
• B: CDC’s Core Elements
• C: Patient education
• D: All of the above
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Assessment Question #2
• The Joint Commission antimicrobial stewardship standard elements of performance include:
• A: Leadership commitment
• B: CDC’s Core Elements
• C: Patient education
• D: All of the above
©2011 MFMER | slide-22
Antimicrobial Stewardship:CDC vs. JC vs. CMS
CategoryCDC Core
Elements
Joint
Commission
CMS Conditions
of Participation*
Leadership commitment
Accountability
Drug expertise
Action
Tracking
Reporting
Education (Staff)
Education (Patients)
©2011 MFMER | slide-23
Joint Commission Perspectives®. Approved: New antimicrobial stewardship standard. Copyright 2016 The Joint Commission. July 2016, Volume 36(7)
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/pdfs/core-elements.pdf
CDC = Centers for Disease Control and Prevention
CMS = Centers for Medicare & Medicaid Services
JC = Joint Commission *Informational only, currently not citable
Checklist for Core
Elements Assessment tools for antibiotic
use
CDC/IHI Change Package
Driver diagramMeasurement
framework
Stewardship program examples
©2011 MFMER | slide-25
Center for Disease Control and Prevention. Implementation Resources.
Available at: http://www.cdc.gov/getsmart/healthcare/implementation.html, accessed 10/17/16
Image labeled as ‘Creative Commons’ for reuse, Bing.com
CDC = Centers for Disease Control and Prevention
IHI = Institute for Healthcare Improvement
©2011 MFMER | slide-26
National Quality Partners/National Quality Forum. Available at:
http://www.qualityforum.org/NQP/Antibiotic_Stewardship_Playbook.aspx, accessed 10/16/16
Permission to use image obtained 10/4/16
Assessment Question #3
• The Joint Commission and Centers for Medicare and Medicaid Services have developed their performance requirements for antimicrobial stewardship to overlap with the CDC’s Core Elements.
• True
• False
©2011 MFMER | slide-27
Assessment Question #3
• The Joint Commission and Centers for Medicare and Medicaid Services have developed their performance requirements for antimicrobial stewardship to overlap with the CDC’s Core Elements.
• True
• False
©2011 MFMER | slide-28
Summary
Joint Commission is implementing medication management standard of practice for antimicrobial stewardship, effective January 1, 2017.
Three of the 8 elements of the Joint Commission for Antimicrobial Stewardship Standard include leadership commitment, CDC’s Core Elements, and patient education.
The CDC’s Core Elements are included in the Joint Commission’s Standard and the pending CMS conditions of participation for antimicrobial stewardship.
©2011 MFMER | slide-29
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Antimicrobial StewardshipRegulations, Standards and Elements
Sarah R. Lessard, PharmD, BCPS