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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

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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

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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

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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

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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

Image labeled for reuse. Images.google.com

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

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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

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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

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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)

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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

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Image labeled as ‘Creative Commons’ for reuse, Bing.com

Checklist for Core

Elements Assessment tools for antibiotic

use

CDC/IHI Change Package

Driver diagramMeasurement

framework

Stewardship program examples

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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

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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

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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

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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.

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Antimicrobial StewardshipRegulations, Standards and Elements

Sarah R. Lessard, PharmD, BCPS

Lessard.sarah@mayo.edu