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ANTIMICROBIAL STEWARDSHIP IN THE COMMUNITY HOSPITAL

Practical Tools and Techniques for Implementation

ANTIMICROBIAL STEWARDSHIP IN THE COMMUNITY HOSPITAL

PRACTICAL TOOLS & TECHNIQUES FOR IMPLEMENTATION

Jointly sponsored by:The University of Cincinnati, Potomac Center for Medical Education, and Rockpointe Corporation

Supported by an educational grant from:• Astellas Global Development, Inc.• Cubist Pharmaceuticals, Inc.• Pfizer, Inc.

CME Information

Co-organized with presenting partner:The Society for Healthcare Epidemiology of America

Steering Committee Disclosures

• Stephen Parodi, MD: Nothing to Disclose

• Maureen K. Bolon, MD, MS: Nothing to Disclose

• Elizabeth S. Dodds Ashley, PharmD, MHS, BCPS:Nothing to Disclose

Faculty Disclosures

The faculty reported the following relevant financial relationships that they or their spouse/partner have with commercial interests:

• Presenting Physician, MDCategory – Disclosures

TO BE FILLED IN BY PRESENTING PHYSICIAN

Planner and Manager Disclosures

Non-faculty content contributors and/or reviewers reported the following relevant financial relationships that they or their spouse/partner have with commercial interests:

University of Cincinnati, Potomac Center for Medical Education, and Rockpointe Corporation staff involved with this activity have nothing to disclose.

Educational Objectives

At the conclusion of this activity, participants should be able to: • Evaluate the principles and objectives of an antimicrobial

stewardship program• Identify the barriers to implementing a successful

stewardship program in a community hospital• Discuss antimicrobial stewardship strategies that can be

implemented effectively in a community hospital • Integrate evidence-based practices and resources to improve

antimicrobial use• Facilitate interaction with the medical staff at the health care

facility to promote acceptance of a stewardship program

Case for Antimicrobial Stewardship Programs (ASP)

• 30% of hospital pharmacy budgets due to ABX• 50% of ABX use estimated to be inappropriate• Resistant organisms develop 2º inappropriate use

– MDRO infections have morbidity and mortality– MDROs have costs (LOS, tx failures)

• Evidence shows ASP can improve:– Individual patient outcomes– Decrease resistance patterns– Decrease Clostridium difficile infection– Decreases costs of care

Dellit TH, et al. Clin Infect Dis. 2007;44(2):159-177.Valiquette L. Clin Infect Dis. 2007;45(suppl 2):S112-S121.

Utilization and Resistance

Albrich WC, et al. Emerg Infect Dis 2004;10:514-7

ESKAPE

• Enterobacter• S aureus• Klebsiella (KPC) (NDM-1)• Acinetobacter• P aeruginosa• Enterococcus /ESBL

KPC=K pneumoniae carbapenemases; ESBL=extended-spectrum β-lactamase.

2001

Geographical Distribution of KPC-Producers

Sporadic isolate(s)

Centers for Disease Control and Prevention.

Widespread

Sporadic isolate(s)

November 2006

Geographical Distribution of KPC-Producers

Centers for Disease Control and Prevention.

2010

Geographical Distribution of KPC-Producers

Sporadic and Widespread isolate(s)

Centers for Disease Control and Prevention.

Antibiotic Armageddon

Then Now

Resistance

New

Ant

imic

robi

als

We are here

Incidence and Mortality of CDIAre Increasing in the United States

0

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20

30

40

50

60

70

80

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per Million Population

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Elixhauser A, Jhung M. Healthcare Cost and Utilization Project. Statistical Brief #50. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb50.pdf. Published April 2008. Accessed March 10, 2010.

Redelings MD, Sorvillo F, Mascola L. Increase in clostridium difficile–related mortality rates, United States, 1999–2004. http://www.cdc.gov/EID/content/13/9/1417.htm. Published September 2007. Accessed March 10, 2010.

ASP Goals

• Prevent or slow emergence of ABX resistance• Optimize selection, dose, duration of Tx• Reduce adverse drug events • Reduce secondary infection (eg. CDI, MDROs)• Reduce morbidity and mortality• Reduce length of stay• Reduce health care expenditure

MacDougall C, Polk RE. Clin Microbiol Rev. 2005;18(4):638-656; Ohl CA. J Hosp Med. 2011; 6(Suppl 1): S4-15;

Dellit TH, et al. Clin Infect Dis. 2007;44(2):159-177.

Can Antimicrobial Stewardship Limit the Emergence of Resistance?

• Best evidence for:– Decreased resistant Gram-negative bacilli1,5– Decreased CDI1-4– Decreased VRE1

1. Carling P, et al. Infect Control Hosp Epidemiol. 2003;24(9):699-706.2. Climo MW, et al. Ann Intern Med. 1998;128(12, pt 1):989-995.

3. Pear SM, et al. Ann Intern Med. 1994;120(4):272-277.4. McNulty C, et al. J Antimicrob Chemother. 1997;40(5):707-711.

5. de Man P, et al. Lancet. 2000;355(9208):973-978.

Impact of Antimicrobial Formulary Interventions on ESBL E coli and Klebsiella Species

Reprinted with permission from Lipworth AD, et al. Infect Control Hosp Epidemiol. 2006;27(3):279-286.©The University of Chicago Press. http://www.press.uchicago.edu.

ESBL-EK=extended-spectrum β-lactamase-producing Escherichia coli and Klebsiella species.

ASP Can Make a Difference with HA-CDI

Reprinted with permission from Valiquette L, et al. Clin Infect Dis. 2007;45(suppl 2):S112-S121. ©The University of Chicago Press. http://www.press.uchicago.edu .

Tertiary Care Hospital; Québec, Canada (2003-2006)

CDAD=C difficile-associated diarrhea; Abx=antibiotics.

ASP Can Improve Individual Patient Clinical Outcomes

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20

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Appropriate Cure Failure

AMP

UP

Perc

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RR 2.8 (95% CI 2.1-3.8) RR 1.7 (95% CI 1.3-2.1) RR 0.2 (95% CI 0.1-0.4)

Fishman N. Am J Med. 2006;119(6 suppl 1):S53-S61.

AMP=antibiotic management program; UP=usual practice; RR=relative risk; CI=confidence interval.

Patients at Risk for Pneumonia aeruginosa Treated Appropriately Pre- and Postdecision Support Tool Intervention

Preintervention Postintervention

Patients at Risk for MRSA Treated Appropriately Pre- and Postdecision Support Tool Intervention

MRSA=methicillin-resistant Staphylococcus aureus; Tx=treatment.

Deschambeault AL, et al. Abstract presented at: 46th Annual Meeting of the Infectious Diseases Society of America; October 2009; Philadelphia, PA.

ASP Can Improve Individual Patient Clinical Outcomes

Perc

ent

Perc

ent

Economic Outcomes

Cost

AMP (median)

UP (median)

Difference (95% CI)*

Antibiotics $53 $95 $42 ($-3, $103) Infection-associated costs

$172 $246 $74 ($-40, $197)

Total costs $10,021 $10,615 $594 ($-4510, $5331)

Annual savings (600 interventions/month)

Antibiotics $302,400

Infection-associated costs $533,000

Total costs > $4,250,000

*95% CI (bias corrected) calculated by bootstrapping around the medians.

Fishman N. Am J Med. 2006;119(6 suppl 1):S53-S61.

Randomized Controlled Trial

Total Antibiotic Expenditures MHH 1995-2003

$10.00

$12.00

$14.00

$16.00

$18.00

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1995 1996 1997 1998 1999 2000 2001 2002 2003

Dol

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Total antiinfective-dollars Total antiinfective-dollars/patient day

Mohr JF et al. 44th ICAAC. Abstract #987. November, 2004.

ASP Active

Antimicrobial Stewardship The Cost of Discontinuing a Program

• Large tertiary care academic medical center: ASP Active 2002-2009• FY01-08: ABX Utilization cost savings > $14 million• FY09: Discontinued ASP = CONSEQUENCES

– >$1 million ABX costs FY09 compared with FY08– 33-147% increased cost of broad spectrum agents– Overall DDD increased 4.8% AND broad spectrum DDD increased 26.8%

• Conclusions:– ASP is a long term proposition– The lack of ASP has significant costs

Standiford H, et al. Abstract presented at: Fifth Decennial International Conference on Healthcare-Associated Infections; 2010; Atlanta, GA. Abstract 666.

Key Elements for Successful ASP

• Establish compelling need and goals for ASP• Senior leadership support• Effective local physician champion• Adequate resources (pharmacy, infection preventionist [IP],

microbiology, information technology [IT])• Primary objectives: optimize clinical outcomes and reduce

adverse events, not reduce costs• Good teamwork• Agreed upon process and outcome measures

GuidelinesDomestic and International

• IDSA/SHEA Guidelines1 suggest:– Physician and pharmacist compensated for time

• Guidelines for Antimicrobial Stewardship in Hospitals in Ireland2– Smaller hospitals should have at least one pharmacist with part-time

responsibilities– Regional committees should be set up to serve smaller hospitals or

develop regional guidelines• European Union Project Antibiotic Stewardship International3

– An antibiotic officer is needed For smaller hospitals, individual could be either physician, pharmacist, or

trained microbiologist

1. Dellit TH, et al. Clin Infect Dis. 2007;44(2):159-177; 2. Health Protection Surveillance Centre. http://www.hpsc.ie. Accessed September 29, 2010;

3. Allerberger F, et al. Chemotherapy. 2008;54(4):260-267.

IDSA =Infectious Disease Society of America; SHEA=Society for Healthcare Epidemiology of America.

Physician Champion

• Basic knowledge of antibiotics*• Must show interest in taking a leadership role in the local

community• Respected by his or her peers• Good interpersonal skills• Good team player• Basic understanding of human factors and culture

transformation

*Does not need to be an infectious disease specialist.

Collaboration and Role of the Pharmacist Continuation, Advancement of Knowledge…1990s-Current

Patients

Clinical pharmacists

Clinical pharmacist

and ID physician

Research

Focus on patient safety (randomized

trial)

Operationalize

Antimicrobial Stewardship Program ASP

Antibiotic Stewardship Activities

• Restrictive formulary• Generic substitution• Therapeutic substitution• Restricted use of formulary compounds• Guidelines for appropriate/desired use• Antibiotic order sheets• Prior authorization• Automatic stop orders• Selective reporting of susceptibilities• Computer-assisted programs

Front-end Approach

Physician writes order for “restricted drug”

Order arrives in pharmacy; pharmacist informs physician that drug is “restricted”/“not part of the pathway”/“nonformulary”

Prescribing physician and the “GATE KEEPER” converse

Approval or alternative antibiotic selected

Back-end Approach

Physician writes order Antibiotic is dispensed

At a later date, antibiotics are reviewed

(Targeted list of antibiotics, culture/sensitivity mismatches, ICU patients)

1) Antibiotic changed or continued based on practice guidelines

2) Prescribing physician contacted and recommendation made

Criteria for Selecting Cases for ASP Review

– High-cost agents (eg, linezolid, daptomycin, echinocandins)– Broad-spectrum agents (eg, carbapenems,

piperacillin/tazobactam)– High risk of adverse effects (eg, aminoglycosides)– Intravenous to oral– Syndromic approach (eg, asymptomatic bacteriuria)– High-use agents (facility dependent)– Double coverage of organisms (eg, anaerobes)– 3 or more anti-infectives for >3 days– Susceptibility mismatch

Measures

• Process– Measure surrogate impacts of program– Accountability– Resource utilization– Cost effectiveness

• Outcome– Most difficult to measure– Literature suggests improvement in patient and institutional

level antimicrobial susceptibility– Patient-specific outcomes more difficult to show

Dellit TH, et al. Clin Infect Dis. 2007;44(2):159-177.

Potential Measurements

• Antimicrobial use– Defined daily dose– Days of therapy

• Antimicrobial costs• Timely antibiotic administration and duration• Cultures obtained before antibiotic(s) administered• Adverse drug events• Antimicrobial resistance patterns• C difficile rates• Physician’s acceptance of ASP recommendations

What Can Physicians Do?Can You Improve Through General Guidelines?

• Avoid unnecessary use, especially viral URIs (75%)• Short course – always wins or ties CAP 3d, HAP 8d• Automatic stop orders work• Pathogen-directed therapy

– Microbiology based diagnosis when possible• Seriously ill – start broad → then pathogen specific• Play the numbers

– Pathogen always >106/mL• Dose issue – vancomycin

URI=upper respiratory infection, CAP=community-acquired pneumonia, HAP=hospital-acquired pneumonia.

Reducing Treatment of Asymptomatic Bacteriuria

• Educate about appropriate indication for sending urine cultures– Signs and symptoms of UTI– Pregnant women at 12-16 weeks gestation

Treatment prevents pre-term labor and LBW

– Prior to TURP and other urologic procedures where mucosal bleeding is expected

• Educate about NOT treating positive cultures in the absence of symptoms in other patients– Particularly in the following populations

Diabetic women, Older persons in the community or in long term care, Spinal cord injury patients, Patients with indwelling catheter

Nicolle LE, et al. Clin Infect Dis. 2005;40(5):643-654. US Preventive Services Task Force. http://www.ahrq.gov/clinic/uspstf/uspsbact.htm. Accessed September 29, 2010.

Lin K, Fajardo K. Ann Intern Med. 2008;149(1):W20-W24.

Implementation of SSI Reduction Efforts

• Should be based in a perioperative care committee representing leadership from preoperative testing, anesthesia, operating room (OR) nursing, pharmacy, and infection control

• A physician champion greatly facilitates this activity

• The committee reports to physician leadership through OR committee or other appropriate group

• A uniformly applied set of standing orders reflecting national best practices, with limited physician-specific choices, is the output

Surgical Service Routine Antibiotic Penicillin or Cephalosporin AllergyBurns Cefazolin OR cefuroxime ClindamycinCardiac Cefazolin OR cefuroxime Clindamycin OR Vancomycin

Thoracic Cefazolin OR cefuroxime or amplicillin/sulbactam Clindamycin OR Vancomycin

ColorectalCefoxitin OR Cefotetan or

Amplicillin/Sulbactam or Ertapenem OR Cefazolin plus metronidazole

Clindamycin OR vancomycin plus aminoglycoside OR aztreonam or

fluoroquinoline

General surgery/endocrine cefazolin OR cefuroximeClindamycin OR vancomycin plus aminoglycoside OR aztreonam or

fluoroquinoline

Hepatobiliary (complicated)Cefazolin OR cefuroxime OR

Cefoxitin OR cefotetan OR ceftriaxone OR Ampicillin/ sulbactam

Clindamycin OR vancomycin plus aminoglycoside OR aztreonam or

fluoroquinoline

Plastics, reconstructive, and hand surgery

Cefazolin OR cefuroxime or amplicillin/sulbactam Clindamycin OR Vancomycin

Vascular Cefazolin OR cefuroxime (add vancomycin if synthetic graft is being placed) Clindamycin OR Vancomycin

Orthopedics with TJR Cefazolin OR cefuroxime Clindamycin OR Vancomycin

Recommended Antibiotic Prophylaxis

2011 ASHP Draft prophylaxis guidelines.Antimicrobial prophylaxis for surgery. Treat Guidel Med Lett. 2009;7(82):47-52.

Addendum: Why not ertapenem for surgical prophylaxis? Treat Guidel Med Lett. 2009; (1320). American Society of Health-System Pharmacists Web site. http://www.ashp.org/prophylaxis. Accessed October 11, 2010.

IMPLEMENTING ASP IN A COMMUNITY HOSPITAL

Hospital 1

• Hospital make-up– 150-bed hospital in a rural setting

Single ICU (4 beds), mostly chronically ventilated patients Private practice physicians admit patients; no hospitalist team

– ID physician: 2 private practice groups from the community provide consultation and have admitting privileges

– Pharmacy: 4 full-time pharmacists; pharmacy services from 7:00 AM to 10:00 PM daily

• Formulary structure– P&T committee chaired by chief medical officer

• Microbiology laboratory: contract service

ICU=intensive care unit; ID=infectious disease; P&T=pharmacy and therapeutics.

Stewardship Program: Option 1

• Form antimicrobial stewardship committee– Invite members from each ID practice to cochair the committee– Have representation from key admitting groups within the community

serve on the committee– Committee reports directly to P&T committee

• Initial stewardship activities– Antimicrobial formulary– Daily review of targeted anti-infectives by registered pharmacist– Prepare antibiogram if not already available

• Resources needed– 25% to 50% of a full-time equivalent registered pharmacist– Hourly reimbursement for ID specialist’s time

Stewardship Program: Option 2

• No support from leadership for formal stewardship committee• Identify key pharmacy champion willing to work on this as a

project• Take all stewardship initiatives through P&T committee• Meet with key ID physicians to seek approval of and advice on

initial pharmacy-based stewardship tasks– Start by reviewing antibiotic formulary– Intravenous to oral switch programs– Vancomycin >72 hours without positive culture

Keys to Success for Hospital 1

• Commitment from the private practice ID physicians– This should be done with support from the hospital for at

least part of their services• If no reimbursement approved, consider recruiting help

– A good stewardship program can likely decrease the number of nonbillable “curb-side” calls the groups likely receive, and most programs still generate a lot of consults

Hospital 2

• Hospital make-up– 80-bed hospital in a suburb of a midsize city– No ICU– Hospitalist service primarily admit patients from 3 large practices in the

area– ID physician: ID physician visits once per week from local teaching

hospital; otherwise available by phone– Pharmacy: 2 full-time pharmacists; pharmacy services from

7:00 AM to 7:00 PM daily

• Formulary structure– Part of a large health system (>20 hospitals) with central

P&T committee

• Microbiology laboratory: contract service

Stewardship Program: Option 1

• No key physician or pharmacist champion with time and interest to assist with program

• Combine with other institutions within the health system– Develop system-wide initiatives that could be approved at

system P&T or stewardship committee– Antibiogram for each institution if not already available

• Initial stewardship activities– Begin with guidelines for use of formulary agents– Consider restriction status, given the environment at each

individual hospital

Stewardship Program: Option 2

• Centralized option not feasible• Find a motivated hospitalist to lead the charge at your institution

– Some hospitalists with ID training in practice– Perhaps ID physician from training institution is willing to mentor/provide oversight

• Initial stewardship activities– Guidelines for specific drugs or pathways to standardize treatment of common infectious

diseases– Antibiogram if not already available

• Resources needed– Dedicated time for hospitalist to assist– Will need incremental registered pharmacist, with some training,

to devote time toward this effort– Evaluate electronic software programs to increase efficiency (may be possible with large

system)

Keys to Success for Hospital 2

• Finding appropriate provider leadership– Support from local hospital leadership important– Key decision is whether local provider without ID training

would be respected for ID input vs opinion of larger health system mandate, which may not be accepted

– Some training programs are proposing abbreviated training in ID/stewardship; perhaps hospital would be willing to support some of this training

Hospital 3

• Hospital make-up– 220-bed community hospital affiliated to large teaching hospital– 2 ICUs; total of 20 beds– Trainees staff most services, with hospitalist attending– ID physician: 2 dedicated ID physicians who take small number of

trainees– Pharmacy: 10 full-time pharmacists, providing 24/7 service; 1 full-time

equivalent pharmacist dedicated to clinical pharmacy activities• Formulary structure

– P&T committee and antibiotic subcommittee in partnership with academic medical center

• Microbiology laboratory: on-site at academic medical center• Hospital leadership requesting stewardship program

Stewardship Program: Option 1

• Wrap efforts into the antibiotic subcommittee initiatives of the health system• Physician and pharmacist from Hospital 3 join antibiotic subcommittee • Initial stewardship activities

– Start adapting policies of academic medical center for approval

– Select strategy of restriction or prospective audit

• Resources needed– Dedicated pharmacist time (add on to responsibilities of clinical pharmacy

resource vs incremental position)– ID training for pharmacist– Support for the ID physicians– Tools to track outcomes

Stewardship Program: Option 2

• Not able to integrate with academic center program or program does not exist

• Start separate committee– Partner with ID physician– Seek hospital-wide membership; unique to Hospital 3

• Initial stewardship activities– Create unique antibiogram, if not already in existence– Outline criteria for use of major drug classes or common disease states

• Resources– Very similar to Option 1

Keys to Success for Hospital 3

• Getting training for the pharmacist– ID residency would be ideal, but not realistic given current

supply of programs– Seek out certificate programs conducted throughout the

country, in some cases with remote options– Also, consider preceptorships with area institutions that can

help to get less formalized experience, but lots of real-world knowledge

Centers for Disease Control and Prevention (CDC) Activities: Improving Use• Develop a comprehensive Web-based resource to assist clinicians

interested in implementing stewardship programs and interventions– Background information on antibiotic use

and resistance– Resources for designing and implementing interventions

• Focus on developing an implementation framework that will make stewardship activities practical and feasible in any acute care setting

• Collaborating with the Institute for Healthcare Improvement (IHI) and SHEA to develop a Driver Diagram with practical antibiotic stewardship implementation strategies with the intent of promoting aspects of care in places where improvement is needed.

“Get Smart for Healthcare” Campaign by CDC

The Society for Healthcare Epidemiology of America

Resource Toolkit

• To further assist with the implementation of ASPs, an online tool kit has been developed with this program which includes: – Useful resources specifically designed for clinicians at

nonteaching, community hospitals interested in implementing an ASP

– Practical tools, web links as well as general support materials

• www.rockpointe.com/ASPtoolkit

The Future is Now for ASP• ASP = Improved Patient Safety and Outcomes• ASP = Our stand against resistant organisms• ASP = An improved $ bottom line

To Achieve Success• Get provider and C-suite buy in• Improve antibiotic use NOW• Scale it up• Measure outcomes• Build on your data

What We Hope You’ve Taken From This Program

Recommended Resources

• Decreased inappropriate use– Fishman N. Am J Med. 2006;119(6 suppl 1):S53-S61.– Solomon DH, et al. Arch Intern Med. 2001;161(15):1897-1902.– Apisarnthanarak A, et al. Clin Infect Dis. 2006;42(6):768-775.– Reviewed in Gandhi TN, et al. Crit Care Med. 2010;38(8 suppl):

S315-S323.• Decreased antimicrobial consumption

– Fraser GL, et al. Arch Intern Med. 1997;157(15):1689-1694.– Bantar C, et al. Clin Infect Dis. 2003;37(2):180-186.– Carling P, et al. Infect Control Hosp Epidemiol. 2003;24(9):699-706.– Cheng VC, et al. Eur J Clin Microbiol Infect Dis. 2009;28(12):1447-1456.– LaRocco A Jr. Clin Infect Dis. 2003;37(5):742-743.– White AC Jr, et al. Clin Infect Dis. 1997;25(2):230-239.– Gross R, et al. Clin Infect Dis. 2001;33(3):289-295.

• Adherence with guidelines– Reviewed in Gandhi TN, et al. Crit Care Med. 2010;38(8 suppl):S315-S323.– Cheng VC, et al. Eur J Clin Microbiol Infect Dis. 2009;28(12):1447-1456.– Arnold FW, et al. Infect Control Hosp Epidemiol. 2006;27(4):378-382.– Beardsley JR, et al. Chest. 2006;130(3):787-793.

• Better patient outcomes from infection– Fishman N. Am J Med. 2006;119(6 suppl 1):S53-S61.– White AC, et al Clin Infect Dis. 1997 25:230-239.

• Reduced length of hospital stay– White AC Jr, et al. Clin Infect Dis. 1997;25(2):230-239.– Fraser GL, et al. Arch Intern Med. 1997;157(15):1689-1694.– Coleman RW, et al. Am J Med. 1991;90(4):439-444.– Gentry CA, et al. Am J Health Syst Pharm. 2000;57(3):268-274.– Fishman N. Am J Med. 2006;119(6 suppl 1):S53-S61.

• Improved ventilator-acquired pneumonia (VAP) outcomes– Singh N, et al. Am J Respir Crit Care Med. 2000;162(2, pt 1):505-511.– Reviewed in Gandhi TN, et al. Crit Care Med. 2010;38(8 suppl):S315-S323.

Recommended Resources

ANTIMICROBIAL STEWARDSHIP IN THE COMMUNITY HOSPITAL

Practical Tools and Techniques for Implementation

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