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Exploring New Horizons in Antimicrobial Stewardship: Hospital Setting and BeyondAshley Cubillos, Pharm.D, BCPS, BCIDP

Pharmacy Clinical Specialist – Infectious Diseases

Lee Health (Fort Myers, FL)

Ashley.Cubillos@Leehealth.org

Timothy P. Gauthier, Pharm.D., BCPS, BCIDPAntimicrobial Stewardship Program Manager

Baptist Health South Florida

TimothyGa@baptisthealth.net

#FSHP2021

DISCLOSURE - AC

I do not have (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation.

#FSHP2021

DISCLOSURE - TG

I have (or an immediate family member has) a vested interest in or affiliation with a corporate offering financial support or grant monies for this continuing education activity or organization with any organization that has a specific interest in the therapeutic areas under discussion, as follows:

• Owner, Charlie Rose LLC (www.LearnAntibiotics.com)• Consultant or other relationship: Pattern Biosciences,

DoseMe by TabulaRasa, Sanford Guide, Antimicrobial Therapy Inc, and Spectrum Mobile Health

#FSHP2021

Educational Objectives for Pharmacists and Technicians

1. Compare antimicrobial stewardship strategies for inpatients, transitions of care, ambulatory care, and long term care

2. Discuss regulations impacting antimicrobial stewardship across practice settings

3. Describe best practices for antimicrobial stewardship across the continuum of care

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Antimicrobial Stewardship (AMS): Through the Sands of Time #FSHP2021

Nolen W, Dille D. N Engl J Med. 1957;257:33-34Chretien J, et al. Arch Intern Med. 1975; 135(8):1063-5Kunin C. Ann Intern Med. 1983;99(6):859-60.Recco R et al. JAMA 1979; 25(21): 2283-6

Society Guidance on AMS #FSHP2021

Murr et al. J Infect Dis 1988:157:869-76Dellit et al Clin Infect Dis. 2007;44:159-77Barlam et al. Clin Infect Dis 2016:62:e51-77

2007

2016

1988Predominant focus: acute care

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Acute Care AMS: Are We There Yet?• Percentage of hospitals

meeting all CDC Core Elements• 2014: 41%• 2018: 85%

• Opportunities still abound• Magill et al (2021) – 192 hospitals• Prescribing “unsupported”:

• 79.5% of community acquired pneumonia• 76.8% of urinary tract infection• 46.5% of fluoroquinolone use

CDC Core Elements of Antimicrobial Stewardship; 2019. Magill et al. JAMA Network Open. 2021;4(3):e212007.

Acute Care’s “Bread and Butter”:Persuasive vs. Restrictive Approaches

• Prospective Audit and Feedback • Review of antibiotic agents in real time

+ communicating interventions • Applicable to many settings (ICU,

immunocompromised, pediatrics)• Labor intensive

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Barlam et al. Clin Infect Dis 2016:62:e51-77LaRosa M et al. Infect Control Hosp Epidemiol. 2007 May ; 28(5): 551–556.

• Restriction/Pre-Authorization • Antibiotic approval pagers• Restriction by service, agent, etc.

Both strategies have evidence for: Decreased antibiotic use Decreased cost Decreased resistance Decreased Clostridioides difficile

infection (CDI) No negative impact on patient

outcomes

Acute Care AMS: Other Strategies

Strategies with moderate-quality evidence:• Intravenous-to-oral transition• Blood culture rapid diagnostics

#FSHP2021

Barlam et al. Clin Infect Dis 2016:62:e51-77

Strategies with low-quality evidence:• Local clinical practice guidelines

• Syndrome-specific interventions

• Antibiotic time-outs

• Clinical decision support

• Cascade susceptibility reporting

• Rapid viral testing

• Serial procalcitonin

• Penicillin allergy assessment/testingHow to choose?• Institution-specific needs

(medication use evaluation)• Available resources• Anticipated benefit

Acute Care AMS: Combining Strategies

Example: utilization of procalcitonin + respiratory viral diagnostics + electronic health record alert

Results:

• Antibiotic duration ~2.2 days

• Antibiotics discontinued w/in 24h: 38%(vs. 19%)

• Fewer patients discharged on antibiotics: 20% (vs. 49%)

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Moradi et al. Clin Infect Dis 2020 Oct;71(7)

Acute Care AMS: Beyond the Stewardship Guidelines

MRSA nasal swab • Use: antimicrobial de-escalation in pneumonia

• Negative predictive value 96.5%

• 2019 IDSA/ATS Community-acquired pneumonia guidelines:

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Parente et al. Clin Infect Dis 2018;67(1)Metlay et al. Am J Respir Crit Care Med 2019 Oct; 200Baby et al. Antimicrob Agents Chemother. 2017 Apr; 61(4)Willis et al. Am J Health-Syst Pharm 2017; 74

Decreased vancomycin duration• ~48hr

Decreased number of vancomycin levels

Vancomycin or linezolid

ordered for pneumonia

Pharmacist orders MRSA

swab per protocol

Pharmacist recommends

discontinuation of anti-MRSA antibiotic if

negative

Pharmacist-Driven Protocols:

AMS Outcome Metrics: The Great Debate #FSHP2021

Moehring et al. Clin Infect Dis 2017:64Al-Hasan et al. Antibiotics 2019:8

Clinical Outcomes• 30-day infection-related readmissions• Mortality

Unintended Consequences• Clostridioides difficile infection (CDI) incidence• Infections with resistant organisms

Antibiotic Utilization• Days of therapy/patient days

Process Measures• Appropriateness per institutional guideline• Number of de-escalations performed

Financial Measures• Antibiotic costs

CDC Core Elements 2019:• Emphasize NHSN Antibiotic Use (AU)

Module reporting

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AMS Outcome Metrics: NHSN Antibiotic Use Module #FSHP2021

NHSN Antimicrobial Use and Resistance Options. https://www.cdc.gov/nhsn/psc/aur/index.html, Accessed 2 May 2021.

Days of therapy/1000 patient days present Standardized Antibiotic Administration Ratio (SAAR)

Also: Antibiotic Resistance (AR) Module

SAAR Breakdown:

• Ward• ICU• Step-down• Surgical• Hematology-oncology

• Antibiotic category• Resistant gram positive• Resistant gram negative• High CDI risk• Community-acquired • Hospital-onset

Transitions of Care (TOC): Missing Opportunities?

• What can go wrong at hospital discharge?• Duration • Dosing • Agent selection (e.g. fluoroquinolone overuse)• Pending microbiology• Unnecessary IV therapy

• Michigan Hospital Consortium analysis (N=21,825):• 49.1% antibiotic overuse• Pneumonia: 63.1% duration too long• UTI: 43.9% treatment for asymptomatic bacteriuria

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Vaughn V et al. Clin Infect Dis., published online 11 Sep 2020.

Improving the Transition• No established guideline

recommendations

• The Henry Ford Health System AMS TOC• Identification of patients pre-

discharge• Assessment by primary

pharmacist• Placement of discharge orders• Communication in medical

record

#FSHP2021

Henry Ford Health System. AMS TOC: Program Overview. https://www.henryford.com/hcp/academic/ams-toc/tools. Accessed 23 May 2021.

Improving the Transition #FSHP2021

Henry Ford Health System. AMS TOC: Program Overview. https://www.henryford.com/hcp/academic/ams-toc/tools. Accessed 23 May 2021.

Long Term Care (LTC): A Long Time Coming #FSHP2021

Jump et al. J Am Med Dir Assoc. 2017;18(11):913–20 Wu JH et al. J Am Geriatr Soc 2019;67:392–99 Cassone M, Mody L. Curr Geriatr Rep. 2015; 4(1): 87–95

November 2017: LTC Antimicrobial Stewardship Programs required by CMS

Frequent 50-80% of

residents per year

Antibiotic Use MDRO Colonization

C. difficile (up to 50%)

MRSA (up to 60%)

Gram negative

(up to 50%)Inappropriate

up to 75%

Recommendation

MDRO = multi-drug-resistant organism

LTC: The Elements of Success #FSHP2021

Kullar et al. Clin Infect Dis 2018;66(8):1304–12Jump et al. J Am Med Dir Assoc. 2017;18(11):913–20

Acute care staff Resources

LTC facility

staff

Antibiotic use

protocolsKnowledge

Patient and family education

Data feedback

Measurement and Monitoring

Antibiotic use data

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LTC: Educational Interventions #FSHP2021

Stone et al. Infect Control Hosp Epidemiol. 2012;33(10):965–77Loeb et al. Infect Control Hosp Epidemiol. 2001;22(2):120-4

Minimum criteria for antibiotic initiation• Loeb 2001

• E.g.: skin/soft tissue infection

Review of antibiotic appropriateness• McGeer 2012

Criteria for Antibiotic Initiation: Skin/Soft Tissue Infection

• New/increasing purulent drainage at wound/skin site

Or• ≥2 of: fever, redness, tenderness,

warmth, or swelling (new/increasing)

LTC: Educational Interventions #FSHP2021

https://www.ammi.ca/?ID=127 (Accessed May 15 2021)

Established educational initiatives (e.g. Symptom Free Pee)

New Horizons: The Ambulatory Patient

• 2018: 249,800,000 outpatient antibiotic prescriptions

• ~30% of outpatient Rx completely unneeded

• Up to 50% inappropriate

• Addressing the stewardship need• CDC Core Elements (2016)• Joint Commission (2019)

• Outpatient stewardship: developing• Vizient survey: 7% “fully functional”

#FSHP2021

CDC. Outpatient prescriptions – United States, 2018. CDC. Antibiotic Use in the United States, 2018 Update. CDC; 2019.Fleming-Dutra et al. JAMA. 2016;315(17):1864-73.Eudy et al. Open Forum Infect Dis 020 Oct 24;7(11):ofaa513

Opportunities for Ambulatory Stewardship

Primary Care Urgent Care Emergency

DepartmentInfusion Centers

Dialysis Centers

Dental Practices

Specialty Clinics

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Sanchez, G.V. et al. MMWR Recomm Rep 2016;65(No. RR-6):1–12

Where to begin? Consider:• Degree of opportunity• Leadership commitment• Availability of resources

HK5

Pathway for Outpatient Interventions #FSHP2021

Sanchez, G.V. et al. MMWR Recomm Rep 2016;65(No. RR-6):1–12Marcelin J et al. Infect Control Hosp Epidemiol 2020;41:833–40Drekonja D et al. Infect Control Hosp Epidemiol 2015;36:142–52

Create Team• Leadership

commitment• Team members

Assess Opportunity• Evaluate prescribing

data• Select target• Assess barriers

Create Intervention• Treatment pathways• Behavioral

interventions• Health record

Provide Education• Clinicians• Patients

Provide Data• Practice-level• Clinician-level

Evaluate Progress • Celebrate wins• Adjust course• Find new opportunities

Example: the Lee Health Experience

• Setting: urgent care

• Opportunity: fluoroquinolone (FQ) utilization in urinary tract infection (UTI)

• Intervention:• Treatment pathway• SmartSet optimization• Education • Prescriber-level data feedback

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Cubillos A et al. Open Forum Infect Dis, 2020;Oct; 7(Suppl 1): S77.Lee Health Internal Data

Prescriber "C”

0

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30

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50

60

% o

f pat

ient

s with

UTI

dia

gnos

is p

resc

ribed

a F

Q

FQ for UTI at Lee Convenient Care January-March 2019

Prescriber

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Slide 22

HK5 I think it is worthwhile to expand on this point a bit - most of the audience are inpatient/healthsystem pharmacists, so perhaps give them ideas within their healthsystem before you transition to the next slide with more details.Hernando Kathryn, 6/9/2021

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Example: the Lee Health Experience

• Outcome: • Implemented April 2019• Fluoroquinolone use in UTI 17% 3%• Sustained after data feedback ceased

• Expansion:• August 2019 – primary care, employee health• Fluoroquinolone use in UTI 23% 7%

#FSHP2021

Cubillos A et al. Open Forum Infect Dis, 2020;Oct; 7(Suppl 1): S77.

Percent of UTI visits receiving FQ

Conclusion: Antimicrobial Stewardship Across the Continuum of Care

• Stewardship opportunities exist in all settings

• Key success strategies across settings:• Diverse team with adequate resources• Review and feedback of prescribing data • Customize to available resources, needs, and practice

• Stewardship has come far – but opportunities abound!

#FSHP2021

Discuss regulations impacting antimicrobial stewardship across practice settings

Regulatory Landscape Snapshot*

AreaCDC Core Elements

Active Pending Notes

Critical Access Hospitals Hospitals TJC CMS TJC standards under revision

Ambulatory Care Outpatient TJC

Long-Term CareNursingHomes

CMS

Ambulatory Surgical Centers

Outpatient Leapfrog

TJC = The Joint Commission; CMS = Centers for Medicare and Medicaid Services

*There may be regulations not identified here. Not all standards/surveys are applicable to all practices in a given area.

Driving Regulatory Change – “CARB”

https://aspe.hhs.gov/system/files/pdf/264126/CARB-National-Action-Plan-2020-2025.pdf

National HAI Action Plan

https://health.gov/our-work/health-care-quality/health-care-associated-infections/national-hai-action-plan

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CDC Core Elements

https://www.cdc.gov/antibiotic-use/core-elements/index.html https://health.gov/sites/default/files/2019-09/National_Action_Plan_to_Prevent_HAIs_Phase_IV_2018.pdf

https://health.gov/sites/default/files/2019-09/National_Action_Plan_to_Prevent_HAIs_Phase_IV_2018.pdf

2019 Core Elements Update

https://www.cdc.gov/antibiotic-use/core-elements/hospital.html

Federal Coordination on ASP

https://health.gov/sites/default/files/2019-09/National_Action_Plan_to_Prevent_HAIs_Phase_IV_2018.pdf

Inspiration credit: Dr. Emily Heil

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Regulations In Hospitals #FSHP2021

https://www.jointcommission.org/-/media/enterprise/tjc/imported-resource-assets/documents/new_antimicrobial_stewardship_standardpdf.pdf?db=web&hash=69307456CCE435B134854392C7FA7D76

MM.09.01.01

https://www.jointcommission.org/-/media/enterprise/tjc/imported-resource-assets/documents/new_antimicrobial_stewardship_standardpdf.pdf?db=web&hash=69307456CCE435B134854392C7FA7D76

TJC Perspectives; May 2021, 41(5)

Regulations In Ambulatory Care #FSHP2021

https://www.jointcommission.org/standards/r3-report/r3-report-issue-23-antimicrobial-stewardship-in-ambulatory-health-care/

BHSF Urgent Care ASP1. Establish a leader: Corporate ASP Pharmacist & Urgent Care

Provider as co-champions

2. Annual goal: Acute respiratory tract infections

3. Guidelines/ protocols: Evidence-based power plans implemented, other guidance documents made available

4. Education: Through emails, online CME, in-person, “nudge” posters deployed, etc.

5. Data: Azithromycin prescribing for ARI diagnosis

BHSF = Baptist Health South Florida

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Notes & References

TJC Interpretation FAQ Resource

https://www.jointcommission.org/standards/standard-faqs/

Do all ambulatory organizations need to address antimicrobial stewardship?

https://www.jointcommission.org/standards/standard-faqs/ambulatory/medication-management-mm/000002258/

What are the expectations for an antimicrobial stewardship program?

https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/medication-management-mm/000002045/

What are the expectations for an antimicrobial stewardship program?

https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/medication-management-mm/000002045/

TJC SAG

https://www.jointcommission.org/-/media/tjc/documents/accred-and-cert/survey-process-and-survey-activity-guide/2021/2021-all-programs-organization-sag.pdf

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CMS ASP Regulations

https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-reduction-conditions-participation-final-rule-cms-3346-f

CMS: ASP + IPC

https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-20736.pdf

Interpretive Guidelines Coming… Soon?

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf

Regulation

What we are waiting for

CMS & ASP in LTCF

https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities

Ambulatory Surgery Centers

https://www.leapfroggroup.org/asc-survey-materials/asc-details-page

1. Leadership Support2. Accountability3. Policies4. Interventions to

Improve Antibiotic Use5. Education

Important ASP Regulatory Notes

• Regulators not listed in this presentation may have standards on antimicrobial stewardship

• Regulations can vary by state, practice setting, and organization

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NQF PlaybookCategorize your program’s elements as:

A. Basic

B. Intermediate

C. Advanced

https://bhbluecoat2.bhssf.org:444/?cfru=aHR0cDovL3d3dy5xdWFsaXR5Zm9ydW0ub3JnL05RUC9BbnRpYmlvdGljX1N0ZXdhcmRzaGlwX1BsYXlib29rLmFzcHg=

Conclusion: Regulatory • Antimicrobial stewardship strategies should be tailored to the

institution while considering practice site nuances

• Antimicrobial regulations now exist in several areas of practice and are expected to expand in the future

• Resources exist from which to derive new antimicrobial stewardship initiatives, but we still have a lot to learn across the continuum of care

THANK YOU!Exploring New Horizons in Antimicrobial Stewardship: Hospital Setting and Beyond

#FSHP2021

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