antimicrobial stewardship program (asp): …...antimicrobial stewardship program (asp): regulations,...

Antimicrobial Stewardship Program (ASP): Regulations, Standards and Elements

Nikunj Vyas, Pharm.D., BCPSClinical Pharmacy Specialist/Infectious Diseases

Kennedy Health SystemStratford, NJ 08084

[email protected]

Disclosure

• None

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

Factors Driving the National Implementation of ASPs in 2017

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


Geographical distribution of extreme-drug resistant Klebsiella bacteria


https://resistancemap.cddep.org/AntibioticResistance.php

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


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


• 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

http://www.cdc.gov/getsmart/healthcare/resources/factsheets/pdf/antibiotic-use.pdf

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

Update on Federal and State Efforts Prompting Actions

Barlam, T et al. Clinical Infectious Diseases ; 2016 ; 62 : 51 -77

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

http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html

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

Accreditation and Regulatory Efforts Prompting Actions:

The Joint Commission

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


Leadership


• 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)


Education


• 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.


ASP Team


• 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


Core Elements

• 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.



Hospital Protocols

• 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


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

Example of Treatment Order Sets


Data Collection

and Review


• 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

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2014

Q1

2014

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2014

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2014

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2015

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2015

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2015

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2015

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2016

Q1

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2017

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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


Acute care http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.pdf


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


Acute care and Critical Access Hospital (CAH)

Proposed COPs (June 2016) require acute care and CAHs to have an ASP- Expect finalization in …….


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

Antimicrobial Stewardship: Role of Pharmacy

Role of Pharmacy in ASP

Pharmacy department

Congratulations, you are all now doing ASP activities!! I am an ASP superhero

https://vignette.wikia.nocookie.net/batman/images/1/12/TDKR_GCPD.jpg/revision/latest?cb=20120719144128

https://static.comicvine.com/uploads/scale_small/11/113509/4693444-6164752601-ben_a.jpg

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



However, more and more I think hospitals are going to have both!

Pharmacy department



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

Antimicrobial Stewardship Program (ASP): Meeting Regulations and Improving Patient

Outcomes

Nikunj Vyas, Pharm.D., BCPSClinical Pharmacy Specialist/Infectious Diseases

Kennedy Health SystemStratford, NJ 08084

[email protected]

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