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Antimicrobial Stewardship Program (ASP): Regulations, Standards and Elements
Nikunj Vyas, Pharm.D., BCPSClinical Pharmacy Specialist/Infectious Diseases
Kennedy Health SystemStratford, NJ 08084
n.vyas@kennedyhealth.org
Objectives• Describe the factors that are driving the implementation of
Antimicrobial Stewardship Program (ASP) nationally in 2017
• Provide an update on the current status of regulatory and accreditation measures that are prompting actions
• Review the Joint Commission Antimicrobial Stewardship Standard
• Discuss how to integrate ASP into your hospital culture and role of pharmacy in diverse ASP models to meet the standard
Antimicrobial Resistance Challenges
“In such a case the thoughtless person playing with penicillin treatment is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope the evil can be averted.”
- Sir Alexander Fleming- Nobel Lecture, December 11, 1945
https://ka-perseus-images.s3.amazonaws.com/6e2a37748c2e08b808b3fc0926215523e5391a95.jpg
https://www.nobelprize.org/nobel_prizes/medicine/laureates/1945/fleming-lecture.pdf
Antimicrobial Resistance Challenges
CDC. Antibiotic Resistance Threats in the United States. Available at: http://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf
Geographical Distribution of KPC(CRE)-Producers
Widespread
Sporadic isolate(s)
November 2006
Centers for Disease Control and Prevention.
Geographical distribution of extreme-drug resistant Klebsiella bacteria
KPCs received
August 2010
Centers for Disease Control and Prevention.
Geographical distribution of extreme-drug resistant Klebsiella bacteria
Centers for Disease Control and Prevention.
Antimicrobial Use Challenges
• Elderly patient population increasing
• Bacteria developing more resistant strains• Extended-spectrum beta-lactamases (ESBLs)• Carbapenemases• Staphylococcus aureus- MRSA, VISA, VRSA
• Very limited antibiotics being developed
A. Srinivasan. CDC Expert Commentary. Three Steps to Antibiotic Stewardship. Medscape 2010. Available at: http://www.medscape.com/viewarticle/731784, accessed 10/16/16A. Trivedi K, DumartinC, 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
Antimicrobial Use Challenges
http://www.cnbc.com/2014/01/16/antibiotic-resistance-economist-proposes-superbug-solution.htmlCDC. Get Smart Programs and Observances. Available at: http://www.cdc.gov/getsmart/index.html
Antimicrobial Use Challenges
• Antibiotics are among the most commonly prescribed drugs used in human medicine• 50% are not needed or not optimally prescribed
• Annual impact of antibiotic resistant infections• 2 million illnesses• 23,000 deaths• 8 million additional hospital days• $20-35 billion excess direct healthcare costs• Up to $35 billion societal costs
PCAST Report to the President on Combating Antibiotic Resistance.
CDC. Appropriate Antibiotic Use –Saves lives, saves money, makes sense. Available at : http://www.cdc.gov/getsmart/healthcare/resources/factsheets/pdf/antibiotic-use.pdfInfect Control HospEpidemiol2014;35(10):1229-1235
Timeline of Recent Events
CDC Federal Engagement in Antimicrobial Resistance.
• CDC report: Antibiotic Resistance Threats in the United StatesSEPTEMBER
2013
• PCAST Report to the President on Combating Antibiotic Resistance• National Strategy to Combat Antibiotic-Resistant Bacteria (CARB)• Executive Order 13676: Combating Antibiotic-Resistant Bacteria
SEPTEMBER2014
• National Action Plan for Combating Antibiotic-Resistant BacteriaMARCH2015
• White House hosts the Forum on Antibiotic StewardshipJUNE2015
• CARB First 180 Days Report• The Joint Commission (TJC) Proposed Standards for Antimicrobial
Stewardship
NOVEMBER2015
White House 2014-2015
• Prevent infections and the spread of antibiotic resistance
• Track resistant bacteria• Improve the use of today’s
antibiotics (Antimicrobial Stewardship)
• Promote the development of new antibiotics and development of new rapid diagnostic tests, especially for resistant bacteria
PCAST-President’s Council of Advisors on Science and Technology
Proposed Policy Changes• Strengthen antibiotic stewardship in inpatient, outpatient, and
long-term care settings– Alignment with CDC Core Elements– Compliance with Conditions of Participation and The Joint
Commission (TJC) Accreditation requirements• Implement annual reporting of antibiotic use in inpatient and
outpatient settings and identify variation at geographic, provider, and patient levels
• Establish and improve antibiotic stewardship programs across allhealthcare settings
• Reduce inappropriate antibiotic use by 50% in outpatient settings and 20% in inpatient settings
• Establish State Antibiotic Resistance (AR) Prevention (Protect) Programs in all 50 states
Federal: Core Elements for ASP
CDC. Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health and Human Services, CDC;2014.
Federal: CDC Core Elements
Care Area CDC Companion Document
Acute care http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.pdf
Small and Critical Access Hospital
http://www.cdc.gov/getsmart/healthcare/implementation/core-elements-small-critical.pdf
Long-term care http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship.pdf
Outpatient and clinic http://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6506.pdf
U.S. Acute Care Hospitals Implementation of Core Elements NHSN 2014
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.
What are the next steps?
• The CDC is working toward getting every acute care hospital in the country to report their data into the Antibiotic Use (AU) module in the NHSN data base.
• This module allows for hospitals to track antibiotic use for key categories and locations
• In addition, it produces a metric known as the Standardized Antibiotic Administration Ratio (SAAR)
CDC. Appropriate Antibiotic Use –Saves lives, saves money, makes sense. Available at : http://www.cdc.gov/getsmart/healthcare/resources/factsheets/pdf/antibiotic-use.pdf
Antimicrobial Stewardship Standard
• Medication Management (MM.09.01.01)• Effective January 1, 2017• 8 Elements of Performance (EP)
TJC: Antimicrobial Stewardship Standard MM.09.01.01
https://www.jointcommission.org/assets/1/6/New_Antimicrobial_Stewardship_Standard.pdfhttps://www.jointcommission.org/assets/1/6/HAP-CAH_Antimicrobial_Prepub.pdf
Antimicrobial Stewardship Standard
• 1. Leaders establish antimicrobial stewardship as an organizational priority.– Accountability documents– Budget plans– Infection prevention plans– Performance improvement plans– Strategic plans– Use of EMR to collect ASP data
Joint Commission Perspectives®. Approved: New antimicrobial stewardship standard. Copyright 2016 The Joint Commission. July 2, Volume 36(7)
Antimicrobial Stewardship Standard
• 2. The hospital educates staff and licensed independent practitioners involved in antimicrobial ordering, dispensing, and monitoring about antimicrobial resistance and antimicrobial stewardship practices. – Education occurs upon hire or granting of initial privileges and
periodically thereafter, based on organization need
• 3. The hospital educates patients, and their families as needed, regarding the appropriate use of antimicrobial medications, including antibiotics.
Antimicrobial Stewardship Standard
• 4. The hospital has an antimicrobial stewardship multidisciplinary team that includes the following members, when available in the setting:– Infectious Diseases Physician– Infection Preventionist(s)– Pharmacist(s)– Practitioner
ASP TeamMultidisciplinary Team Approach to Optimizing Clinical Outcomes*
HospitalEpidemiologist
InfectionPrevention
MedicalInformationSystems
MicrobiologyLaboratory
InfectiousDiseases
Director QualityCase Management
Chair,P&TCommittee
Partners in Optimizing
Antimicrobial use suchas hospitalists, intensivists, ED,
and surgeons
Hospital and NursingAdministrator
ASP Directors• Clinical Pharmacist• Physician Champion
ClinicalPharmacySpecialists
DecentralizedPharmacySpecialist
Modified from : Dellit TH et al. Clin lnfect Dis. 2007;44:159-177.*based on local resources
• 5. The hospital’s antimicrobial stewardship program includes the following core elements: (Same as CDC Core Elements)
CDC. Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health and Human Services, CDC;2014.
Antimicrobial Stewardship Standard
• 6. Hospital’s antimicrobial stewardship program uses organization-approved multidisciplinary protocols
• Examples include:– Antibiotic time out– Order sets and guidelines for adult and pediatric patients– Antibiotic formulary restrictions– Auto-substitution policies, IV to PO conversion policies
Antimicrobial Stewardship Standard
Examples of Initiatives to Alter Prescribing at Kennedy Health
• Providing inpatient treatment guidelines and order sets• Suppressing certain antibiotics on the culture and sensitivities
reports (i.e. cascade reporting)• Formulary and indication restrictions• Best practice alerts/warnings/ordering questions to verify
indications• Integrate lab tests with algorithms or decision trees to help
select correct tests
Examples Antibiotic Indication/Timeout
Cascade Reporting
Formulary Restriction
Lab Tests with Guidance
Antimicrobial Stewardship Standard
• 7. The hospital collects, analyzes, and reports data on its antimicrobial stewardship program.
• Examples of topics to collect and analyze data include– Evaluation of the antimicrobial stewardship program– Antimicrobial prescribing patterns– Antimicrobial resistance patterns
• 8. The hospital takes action on improvement opportunities identified in its antimicrobial stewardship program
Examples
Infection Prevention Team• Monitoring MDRO
Pathogens– MRSA, ESBL, KPC, Cdiff, VRE
• Monitoring rates of SSI, CAUTI, VAP
• Occupational exposure• Employee screenings• Education for staff
-113579111315
0100200300400500600700800900
1000
2014
Q1
2014
Q2
2014
Q3
2014
Q4
2015
Q1
2015
Q2
2015
Q3
2015
Q4
2016
Q1
2016
Q2
2016
Q3
2016
Q4
2017
Q1
2017
Q2
HO-C
DI
DOT/
1000
PD
DOT vs CDI WT
What is on the horizon?
• Further extension of formalized efforts in outpatient settings• Expansion of state and regional efforts
CDC Core Elements
Care Area CDC Companion Document
Acute care http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.pdf
Small and Critical Access Hospital
http://www.cdc.gov/getsmart/healthcare/implementation/core-elements-small-critical.pdf
Long-term care http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship.pdf
Outpatient and clinic http://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6506.pdf
Federal: CMS Conditions of Participation
Care Area CDC Companion Document
Acute care and Critical Access Hospital (CAH)
Proposed COPs (June 2016) require acute care and CAHs to have an ASP- Expect finalization in …….
Small and Critical Access Hospital
Long-term care Final COPs release (August 2016) – Require an ASP in nursing homes but less prescriptive
Outpatient and clinic ------------
http://www.cidrap.umn.edu/sites/default/files/public/downloads/asp_policy_update_july_2016.pdfhttps://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-06-13.html
Antimicrobial Stewardship: CDC vs. JC vs. CMS
Joint Commission Perspectives®. Approved: New antimicrobial stewardship standard. Copyright 2016 The Joint Commission. July 2, 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
State Bills
• California– ASPs required in all acute care and SNFs
• Missouri– All hospitals will have stewardship programs by August 28, 2017– All hospitals will report antibiotic use and resistance data into NHSN
• New Jersey– NJHA Antimicrobial Stewardship Learning Action Collaborative– July 11, 2017: First in person meeting of ASP Collaborative
Role of Pharmacy in ASP
Pharmacy department
Congratulations, you are all now doing ASP activities!! I am an ASP superhero
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Pharmacy department
Pros and Cons of both approaches
1. Lots of personnel (interventions)2. Usually not specialty trained High-
level interventions may not be possible
3. Continuous education of new personnel
1. Limited number of personnel (limited interventions)
2. Usually specialty trained (PGY2/3)3. High-level interventions possible
Pharmacy department
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However, more and more I think hospitals are going to have both!
Pharmacy department
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Pharmacy department
Key Takeaways
• Antimicrobial resistance is a global threat which has triggered a response from the highest levels of the government.
• The CDC core elements are useful document that outline effective actions to help improve antibiotic use.
• The new Antimicrobial Stewardship Standards proposed by CMS and TJC provide guidelines for compliance and success.
• Structuring the pharmacy department in collaboration with your ASP pharmacist lead will lead to best outcomes.
A pessimist sees the
difficulty in every
opportunity, an optimist
sees the opportunity in
every difficulty
Winston Churchill
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