Antimicrobial Stewardship:

The Never Ending Journey

Joan Ivaska, BS, MPH, CICSr Director, Infection Prevention

Banner Health SystemDecember 12, 2013

About Banner Health

24 Acute Care Hospitals

Banner Health Network

Banner Medical Group with >800 doctors

Banner Health Centers and Clinics

Behavioral Hospital

Outpatient Surgery

Medical Education

2012 inpt. admissions/year: 241,646

2012 ED visits/year: 733,976

2012 surgeries/year: 133,532

Defining clinical practiceat Banner Health

Care Management Council Make systemwide clinical decisions Members include CMOs, CNOs, team leaders

CM Clinical Consensus Groups Determine clinical practices based on best available evidence Identify opportunities for improving clinical care Define expected and recommended clinical practices for Banner Health

based on best available evidence. Oversee how clinical practices will be performed and implemented

Define, Design, and Implementation phases Reviews, revises and approves clinical order sets

Objectives

Discuss the importance of an antimicrobial stewardship program

Review the SHEA/IDSA/PIDS Antimicrobial Stewardship Policy Statement and recommendations

Review Banner Health’s approach to antimicrobial stewardship

Antibiotic Use, Costs, andFinancial Outcomes

• Annually in United States– 30% hospital admissions due to infection 1

– 2 million people develop HAI 2

• 23,000 of these individuals die as a direct result of this infection 5

• 30-50% hospitalized pts receive ABX 1,2

• 200 300 million antibiotics are prescribed annually‐– Up to 50% ABX orders are unnecessary or inappropriate 1-3

– 30% of hospital pharmacy budget is composed of antimicrobials 4

– > $1.1 billion spent annually on unnecessary antibiotic prescriptions for respiratory infections in adults 5

– $15 million to treat 188 cases of ABX resistant infections 5

– Attributable costs 4

• MRSA: $9,275 - $13,901• VRE: $27,190 per episode• Resistant Enterobacter: $29,379

1 Gums JG et al. Pharmacotherapy 1999;19:1369-77. 2 Owens Jr RC et al. Pharmacotherapy 2004;24:896-908. 3 Arnold FW et al. J Manag Care Pharm 2004;10:152-58. 4 Dellit TH et al. Clin Infect Dis 2007;44:159-77. 5 www.cdc.gov/getsmart/healthcare/inpatient-stewardship.html6 Centers for Disease Control and Prevention, Antibiotic Resistant Threats in the United States, 2013.

Decline in the Number of New Antibacterial Agents Approved in the USA, 1983-20121

Numbers in arrow bars represents # of new antimicrobials approved by the FDA during the 5-year period listed

1 Boucher H et al. Clin Infect Dis 2009;48:1-12 (up to 2007) 2 Infectious Diseases Society of America. Bad Bugs, No Drugs. July 2004. Available at: www.idsociety.org

Percent Decline in Approved Antibiotics Compared With 1983-1987 (n=16 new agents)

1988-1992 1993-1997 1998-2002 2003-2007

In 2002, out of 89 new drugs, no new antibiotics were approved 2

14

10

75

0

-10%

-20%

-30%

-40%

-50%

-60%

-70%

-80%

-90%

2008-2012

2

Publically Available Information on Antibiotic Resistance: “A National Call to Action”

http://www.consumersunion.org/campaigns/stophospitalinfections/learn.html

Factors That Lead to Inappropriate Use of Antibiotics

Internal• Lack of knowledge of infectious diseases,

e.g., “more antibiotics are better”• “Double coverage is better for killing”• “Expanding” spectrum when consolidation

is better• Lack of knowledge about antibiotics

– What agents cover what pathogens- broader is easier; vancomycin as “broad spectrum”

• Lack of knowledge about dosing-, e.g., “low dose for longer is better”

• Lack of knowledge of antibiotic allergies and their implications

• Lack of knowledge about when to give and stop antibiotics

• Prophylaxis outside of surgical theater

External• Lack of time to educate patients and

prescribers about when antibiotics are not indicated

• Lack of microbiologic data (and acquisition of it)

• Fear of malpractice for not giving an antibiotic

• Misperception that antibiotics have only benefit and no harm

• Pharmaceutical detailing - new does not always equal better

CDC 12 Steps to Prevent Antimicrobial Resistance in Hospitalized Adults

Prevent Infection1. Vaccinate

2. Get the catheters outDiagnose and Treat Infection Effectively9. Target the pathogen

10. Access the expertsUse Antimicrobials Wisely3. Practice antimicrobial control

4. Use local data

5. Treat infection, not contamination

6. Treat infection, not colonization

7. Know when to say “no” to vancomycin

8. Stop treatment when infection is cured or unlikely

Prevent Transmission11. Isolate the pathogen

12. Break the chain of contagion

CDC slides available at: www.cdc.gov/drugresistance/healthcare/ha/slideset.htm1 Cosgrove S, et al. Infect Control Hosp Epidemiol. 2007;28:641-6 9

In a joint study with the CDC, John Hopkins and Univ Louisville Univ Hospital, 87% of potential interventions fit into one of the CDC’s 12-steps, and following staff education, the rate of compliance with recommendations to improve antimicrobial use was 72% 1

Impact of Antibiotic Stewardship Programs

Hospital Size

Participation by CliniciansAntimicrobial Cost

SavingsDrug Resistance & Infectious Diseases

OutcomesID MD Clin RX Micro Data Analyst IP/IC

174 beds x xAnnual cost reduction: $200,000-$250,000

Reduced rate of nosocomial Clostridium difficile and MDR-Enterobacteriaceae

250 beds x x x xCost-savings during 18 month study: $913,236

Decreased resistance rates

650 beds x x x Net savings for 1 year: $189,318

Reduced rate of VRE colonization and bloodstream infections

120 beds x x x x19% decrease ABX costs/pt; annual cost reduction: $177,000

Not reported

McQuillen D, et al. Clin Infect Dis.2008;47:1051-63

SHEA / IDSA / PIDS Policy Statement, 2012

• Antimicrobial Stewardship Programs should be required through regulatory mechanisms

• Antimicrobial Stewardship should be monitored in ambulatory healthcare settings

• Education about antimicrobial resistance and antimicrobial stewardship must be accomplished

• Antimicrobial use data should be collected and readily available for both inpatient and outpatient settings

• Research on antimicrobial stewardship is needed

IDSA Antibiotic Stewardship GuidelinesDellit TH, et al. Clin Infect Dis. 2007;44:159-77

Definition: Judicious use of antimicrobials in order to improve patients outcomes, control resistance and decrease healthcare expense

Achieved through:

CORE STRATEGIESFormulary Pre-authorization &

restrictionProspective audit

with feedback

Education

Streamlining

Information Technology

IV to PO

Dose Optimization

Guidelines Clinical

pathwaysOrder Sets

The Banner ANTIMICROBIAL STEWARDSHIP Plan–ADULT & PEDIATRIC

Six Components:Formulary RestrictionTreatment guidelines/clinical pathwaysComputer surveillance and clinical decision

supportEducation Auditing of Antimicrobial useA centralized system team for antimicrobial

stewardship oversight

Purpose ofAntimicrobial Stewardship

• Guide antimicrobial therapy usage to minimize toxicity, decrease emergence of resistance and selection of pathogenic organisms and improve / optimize patient care.

Clinical Proposal• Overview: All inpatients will be treated with the appropriate

antimicrobial agent(s) to optimize clinical outcomes while minimizing unintended consequences of antimicrobial use.

• Rationale:– the use of antimicrobial medications can be associated with

unintended consequences including: drug toxicity, super infection with Clostridium difficile, and emergence of resistant organisms.

– inappropriate use of antimicrobials remains a common occurrence in health care facilities contributing to increased costs

– antimicrobial resistance results in increased morbidity, mortality and health care costs

– Effective antimicrobial stewardship programs can improve patient care by optimizing the appropriate use of antimicrobials, resulting in improved patient outcomes and decreased costs.

Formulary Restrictions

• Antimicrobials may by restricted based on therapeutic efficacy, toxicity, and to minimize antimicrobial resistance and cost.– Antimicrobial therapeutic substitution

• e.g., ceftaz to cefepime; caspo to micafungin; ambisome to abelcet, 1st and 2nd generation cephalosporins

– Develop Discern alerts to guide appropriate use of high-cost/broad spectrum agents

– Use caresets to guide appropriate use of antimicrobial medications (e.g. sepsis)

Workflow for the Discern Alerts Implementation

Antimicrobial Stewardship

Team or Pharmacy

Discern Alert Request

Present request to Discern

Workgroup

Consensus to create alert? Alert Built Alert TestingYes

Is Alert feasible?

Is Alert functioning optimally?

Yes

Alert modifiedNo

Does alert fire to

providers?

Yes

Pharmacy and

Therapeutics approval?

Yes

Implement Alert

Yes

ANo

A

No

4/4/13

Done

No

No

Review withAntimicrobial Stewardship

Team

DISCERN INFECTIOUS DISEASE ALERT: ANTIMICROBIAL STEWARDSHIP DAPTOMYCIN The following message was an on-screen alert for daptomycin @curdatetime DAPTOMYCIN is not first-line therapy for any Staphylococcal infection. Vancomycin is first line therapy for MRSA and MRSE. Approved uses of daptomycin include failure to respond to appropriately dosed vancomycin after 5 days of therapy, anaphylactic reaction to vancomycin or VRE infection. For further definition of failure to respond see references. Daptomycin cannot be used to treat pulmonary infections. Daptomycin susceptibility testing must be ordered. The order and ordering physician: @misc:8 Reason for override (if available): @misc:9 Reasons for documentation: Criteria 1: non urine VRE infection, symptomatic urinary VRE infection, empiric tx recent VRE infection Criteria 2: Vancomycin allergy/intolerance, excludes red man syndrome Criteria 3: Vancomycin non-response, 3 days worsening Sx, 5 days persistant Sx adequate levels

Discern Website

Treatment Guidelines/Clinical Pathways

• Treatment guidelines and clinical pathways will be developed incorporating evidence-based practice and local microbiology and resistance patterns.

– CCG Clinical Practices/Initiatives such as CAP, Sepsis

• De-escalation of empirical antimicrobial therapy based on culture results so as to eliminate redundant therapy and targeting the causative pathogen.

– Clinical Decision Support Discern Alerts

• Dose optimization based on individual patient characteristics, causative organism, site of infection and drug characteristics.

– Pharmacy Renal Dosing Protocol

• Parenteral to oral conversion when the patients condition allows. – Pharmacy IV to PO Conversion Protocol

Computer Surveillance and Clinical Decision Support

• Computer-based surveillance will provide clinical decision support to optimize clinical outcomes while minimizing unintended consequences of antimicrobial use. • Prescriber Discern alerts for restricted antimicrobials

to provide recommendations and record usage of selected antimicrobials.

• Pharmacy Discern alerts to identify potentially inappropriate/suboptimal antimicrobial therapy based on microbiology results and/or renal function

Education

• Education is an essential element for influencing prescribing behaviors and will be partnered with active interventions for greatest effectiveness (on-going education).

• Antimicrobial Stewardship SharePoint site will provide information related to Antimicrobial Stewardship at Banner.

Auditing Antimicrobial Use• Retrospective audits of clinical decision support antimicrobial

alerts at both a system and facility level • Additional prospective or retrospective audits dependent on

individual facility capabilities• Audits to be performed by appropriate clinical personnel,

including infectious disease physician, clinical pharmacist, infectious disease practitioner or other personnel as determined by facility capabilities

• Metrics measured may include usage patterns, patient outcomes, resistance trends

• Prescribers who repeatedly utilize selected antimicrobials inappropriately will require intervention and feedback.

A centralized system team for Antimicrobial Stewardship Oversight

Oversight Team to review the effectiveness of facilities and system implementation of

the Banner Antimicrobial Stewardship Plan and to determine opportunities for

improvement.

Monitor functionality of the

alertAlert issues?

Email Pharmacy Discern Manager with issue details

Yes

Resolving Alert issue(s)

Evaluating alert outcome metrics

periodically

Monitoring

Evaluating

Quarterly report AST alerts presented to P&T CCG, ID CCG &

facility P&T(s)

Action plans needed?

System Pharmacy Resources audit AST

results

Present findings to AST

Develop action plansYes

Done

No

Antimicrobial Stewardship Team (AST)

Partnering OpportunitiesPharmacy-Microbiology

& Laboratory Pharmacy-Nursing Pharmacy-Infection Prevention Pharmacy-Medical Staff

Rapid testing and notification; MRSA v. MSSA BSI

IV-to-PO transition therapies

Review CDI and MDRO cases for antibiotic use CPOE educational screens

Procalcitonin results Identification of “true” allergy NPSG 7.0’s for MDRO Antibiotic plans in chart

Blood culture contamination

Education and support for prolonged infusions HAIs treated optimally Evidence-based treatment

guidelines

Antibiogram development & education

Rapid initiation of empiric antibiotics

Maintenance of sterile injectables Therapeutic interchange

Empiric antibiotic prescribing guidelines

Reminders to physicians: “did he/she see the C&S report?”

Cleaning of equipment and rooms known to facilitate transmission of pathogens

Restricted or non-formulary antibiotics

Selective reporting rules on AST

SCIP guidelines; time to antibiotic administration

Differentiate colonization from infection

Optimize clinical and economic outcomes

Expected Outcomes

• Antimicrobial Stewardship to become part of daily clinical practice for all healthcare professionals

• Full compliance with restricted uses for select antimicrobials

• Pharmacy evaluation, provider follow-up when indicated and complete documentation of pharmacy antimicrobial Discern alerts.

• Completion of Pharmacy Audits and Provider follow-up• Cost savings associated with antimicrobial use

Banner Health Discern Data

Developing an Antibiotic Stewardship Program:

The Core Team and Supporting Stakeholders

Infection Control

Quality Assurance/ Patient Safety

Information Technology

Hospital Administration & Pharmacy

Director

Infectious Disease Physician

Clinical Pharmacist with ID Training

Microbiology Hospital Epidemiologist

Med Executive & Pharmacy and

Therapeutics Committees

Support Team

Core Team

Collaborative Team

AZ Partnership for ASP, 2012

• Essential components for successful ASP– Support and collaboration of hospital administration, medical staff leadership,

and local providers– Function as a quality assurance and patient safety initiative– Coordinate activities between key stakeholders (e.g. Infectious Diseases,

Pharmacy, Infection Control and Microbiology)– Collaborate and obtain adequate authority to perform activities– Identify expected outcomes for the program

How to Get Started

Dellit TH, et al. Clin Infect Dis. 2007;44:159-77

Twelve Steps to Implementing an ASP

1 Assess motivations for an ASP 7 Define how progress is to be measured; what constitutes success?

2 Identify physician champion; form core group (physician-pharmacy) 8 Establish an implementation plan; identify

phases

3Gain administration support (includes P&T, Med Exec, Departments); business model and physician compensation plan developed

9Identify resources (education of pharmacists, tools, training, medical meetings, networking, society membership, software)

4Identify which of the defined problems/issues will be addressed by the ASP

10Establish frequency of monitoring and documentation; daily activities and hierarchy of notifications

5 Assess barriers to success (level of education, work flow) 11 Establish mechanism and schedule for

reporting of results (to whom?; with what?)

6Identify Team members, roles, responsibilities, and accountabilities; meeting frequency

12 Market the program (internal and external; insurers/contract groups)

Accounting for theNon-Academic Medical Center

Comprehensive program led by ID physician or physician champion,

plus clinical pharmacist

Individual interventions based on goals of

institution, with assistance from interested individuals

Formulary management strategies:• Simple audit (review of orders) of specific drugs - 10 patients• Pharmacy order entry system (unsophisticated)• Develop evidenced-based guidelines for 3-4 agents (see IDSA guidelines as a start)• Educate medical staff (2-minute “elevator speech”)• All pharmacists can apply guidelines and approve drugs• Post-prescription review on days 2-3 with physician champion• IV-to-PO conversion is a good demonstration project• SCIP guidelines and other performance outcomes and measures

Barriers…Perceived and Real:Infectious Diseases Pharmacist

• Dilemma– The number of “ID-trained” clinical pharmacists doesn’t match the demand, nor

do the number of training programs – Requiring completion of a post-graduate ID training program to administer

stewardship would be an impediment at present• Possible solutions:

– Financial and administrative support for in-house and external programs and training

– Programs developed by professional organizations– “Tool kits” to direct baseline activities and enhance existing ones– Best practice sharing (e.g. round tables, web-based)– Partner with other clinical pharmacy specialist colleagues and/or staff pharmacist

to accomplish any or all components

Ernst EJ et al. Pharmacother 2009;29:482-88.

Computer Decision Support Systems (CDSS): Programmable Dashboards

• Programming current computer systems may assist in targeting antibiotic prescribing activities

• Commercial systems (~8) are available for purchase at an appreciable cost

Potential Identifiers

Core measure assessments (CAP) Pathogen-drug mismatch

Creatinine clearance and targeted antibiotics Patients on ≥ 3 antibiotics

Identify antibiotics as IV-to-PO candidates Recent positive cultures

Restricted antibiotic lists Antibiotic therapy ≥ 7 days

Vancomycin ≥ 3 days with + culture for a Gram-positive pathogen Vancomycin therapy for unlikely pathogen

Duplicative therapy Disease-drug mismatch (Zyvox-UTI)

Keys to Success

• One size does not fit all• Perform a baseline assessment of assets, deficits; gather pilot data• Address any deficits that will impede the basic program and fix first• Pre-determine barriers: differentiate the real from the misunderstood• Pro-actively address the valid obstacles • Prioritize available resources as well as additional resources needed• Choose reasonable, sequential initiatives that are practical and beneficial to the

institution and will lead to a logical progression of next steps• Bring in the specialists but realize everyone has a stake in the program…involve them,

encourage them, educate them, report back to them (good and bad)• Cost-reduction of the antimicrobial budget is not a primary justification for

antimicrobial stewardship, but cost-savings will be realized from AST activities• Create a campaign towards antibiotic stewardship

Education/guideline strategiesPatient Evaluation

Choice of antimicrobialto prescribe

Prescription ordering

Dispensing of antimicrobial

Antibiotic cycling strategies

Formulary/restriction strategies

Computer-assisted strategies

Review and feedback strategies

Antibiotic Stewardship: Lessons Learned

“Several strategies, including prescriber education, formulary restriction, prior approval, streamlining, antibiotic cycling, and computer-assisted programs have been proposed to improve antibiotic use. Although rigorous clinical data in support of these strategies are lacking, the most effective means of improving antimicrobial stewardship will most likely involve a comprehensive program that incorporates multiple strategies and collaboration among various specialties within a given healthcare institution.” 1

Figure adapted from: MacDougall C et al.. Clin Microbiol Rev. 2005;18(4):638-56.1 Fishman N. Am J Infect Control. 2006;34:S55-63.

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In Closing…