Understanding the ABCs of and ASP

Understanding the ABCs of an ASPJulie Rubin, Pharm.D., BCPS – CompleteRx Director of Clinical Services

Paul Green, Pharm.D., MHA, BCPS – CompleteRx Clinical Pharmacy Manager

May 24, 2017

CompleteRx Webinar Series

CE Credit: ACPE # 0523-0000-17-004-L01-P

Speakers

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Julie Rubin, Pharm.D., BCPSDirector of Clinical ServicesCompleteRx, Ltd

Paul Green, Pharm.D., MHA, BCPSClinical Pharmacy ManagerCompleteRx, Ltd

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• Recognize the relationship between antimicrobial

resistance on clinical and economic outcomes in various patient populations

• Outline core elements required by TJC in establishing

and influencing the role of ASPs

• Describe the various metrics used to measure antimicrobial utilization

• Recommend clinical interventions for ASPs that can be implemented in various pharmacy practice models

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Learning Objectives

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Disclosure

We wish to disclose that we are employees of

CompleteRx, Ltd. This presentation reflects experience

with the topics at hand. All faculty and planners report

no financial relationships relevant to this activity.

What is Antimicrobial Stewardship?

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What is Antimicrobial Stewardship?

• Coordinated interventions designed to improve and

measure the appropriate use of antimicrobials

(antibiotics, antivirals, & antifungals)

• Promote the selection of the optimal antimicrobial

• Only use antimicrobial when absolutely needed

• Use the lowest dose via the simplest route for the

shortest duration that will be clinical effective

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What is the primary goal for

implementing an ASP?

A. Save Money

B. Reduce length of stay

C. Improve patient outcomes

D. Meet accreditation standards

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Quick Poll

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Goals of Antimicrobial Stewardship

Primary Goals:

Optimize clinical outcomes

Minimize unintended consequences of antimicrobials

– C. diff., Resistance, Adverse reactions, etc.

Secondary Goal:

Reduce healthcare costs without adversely impacting quality of care

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Hot TopicRecommendations from numerous national societies and agencies

Infectious Disease Society of America (IDSA)

Centers for Disease Control and Prevention (CDC)

World Health Organization (WHO)

Society of Healthcare Epidemiology of America (SHEA)

Pediatric Infectious Disease Society (PIDS)

The Joint Commission (TJC)

Hospital Association of New York State (HANYS)

Centers for Medicare and Medicaid Services (CMS)

The White House

Why do we need an Antimicrobial Stewardship Program (ASP)?

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New FDA-Approved Antibiotics

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4

6

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1983-1987 1988-1992 1993-1997 1998-2002 2003-2007 2008-2012

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Antimicrobial Resistance Trends

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Why do we need an ASP?

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Gram Positive Resistance

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Gram Negative Resistance

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>50% 50%

~$20B

Of all inpatients receive an antibiotic

Of antibiotics prescribed are unnecessary or

inappropriate

Excess healthcare cost of antibiotic

resistance in US

National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB)

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Goals: Reduce inappropriate antibiotic use by 50% in outpatient settings and 20% in inpatient settings

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• The CDC has called for all U.S. hospitals to have an ASP by the

year 2020

• As of January 1, 2017, Joint Commission (TJC) requires that

all hospitals seeking accreditation have an active ASP

• CMS is also tracking ASP actions with plans to tie real money

to ASP-related items in the near future

Elements of the ASP Team

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Who’s on an ASP Committee?

ASP

Providers

Nursing

Executive Leadership

IT

Respiratory Therapy

Lab

Clinical Education

Infection Prevention

Quality

Pharmacy

Core Elements for ASPs

1. Leadership commitment from administration

2. Educating providers on use and resistance

3. Antibiotic use tracking

4. Regular reporting on antibiotic use and

resistance

5. Specific improvement interventions

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Leadership Commitment

• Formal expression of support for the

stewardship program from the facility

administration.

• Leadership must ensure that staff have

necessary time, education/competencies and

resources to implement the stewardship

program.

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Program Leadership

• Designated leader

• Physicians have proven very effective in this

role.

Prescribing is a medical staff function

Often an ID physician, but others have filled this role, especially in hospitals with no ID physicians.

• Leadership by committee is not as effective

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Pharmacy Leadership

• Pharmacy leadership is consistently identified as a

MUST for stewardship in hospitals.

• Pharmacists often play a lead role in implementing

improvement interventions and monitoring antibiotic

use - should have training in infectious diseases.

(e.g., MAD-ID)

• Many programs are co-led by a physician and

pharmacist.

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All of the following are

part of the core elements

of ASP except:

A. Leadership commitment

B. Led by Pharmacy

C. Educate on resistance and stewardship

D. Antibiotic use tracking

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Quick Poll

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Education and Training

Core Competencies

• Antibiotic stewardship-

the basics

• IV to PO Conversion

• Renal Dosing

• Pharmacokinetics

Advanced Training Courses

• Antimicrobial streamlining

• Developing an antibiogram

• Empiric guidelines

Actionable Interventions

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Antimicrobial Stewardship Framework

Antimicrobial Formulary RestrictionOrder Sets

Prospective Audit with FeedbackIV to PO ConversionDose Optimization

Audits & ReportsEducationGuidelines

De-escalation/StreamliningDuration of Therapy

AC

TIV

EPA

SSIV

E

BEFORE Rx AFTER Rx

PrescriberAntibiotic

RxPatient

Adapted from Moehring RW et al. Curr Infect Dis Rep. 2012; 14(6): 592 – 600.

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Elements for Consideration and Prioritization

• Parenteral to oral conversion (A-I)

• When the patient’s condition allows• Decrease length of stay

• Decrease healthcare costs

• Development of clinical criteria and guidelines allowing conversion to use of oral agents (A-III)

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• Streamlining or de-escalation therapy (A-II) Based on culture results and elimination of redundant

therapy

Decreases antimicrobial exposure and cost

• Dose optimization (A-II) Based on PK/PD parameters and includes patient

characteristics, causative organism, site of infection, in addition to PK/PD characteristics of the drug

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Advantages of de-escalation

of antimicrobial therapy include:

A. Decreases inappropriate use of antimicrobials

B. Narrows antimicrobial therapy when appropriate

C. Reduces adverse events

D. Allows initial use of broad-spectrum antimicrobials

E. All of the above

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Quick Poll

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Microbiology Stewardship

• Obtain Cultures Prior to Starting Antibiotics!

• Develop a process to ensure cultures are properly and

consistently ordered

• Develop a process to ensure cultures are properly and

consistently obtained

• Develop processes to ensure cultures are properly and

promptly transported and processed

• Develop standards for and assess reliability of processes

for ordering and obtaining a culture

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• Educational programs, active intervention (A-III, B-II)

Provides foundation of knowledge

• Guidelines and clinical pathways – seek multi-

disciplinary involvement and approval (A-I) Incorporate local antimicrobial resistance patterns (A-I)

Provide education and feedback to practitioners (A-III)

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• Antimicrobial order forms (B-II)

Shown to be effective component of the program and can facilitate implementation into practice

• Combination therapy

Insufficient data for routine use (C-II)

Has a role to increase coverage in empiric therapy in patients at risk for multi-drug resistant pathogens

• Antimicrobial cycling – is not recommended because of

insufficient data (no ranking)

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Antibiotic Time OutTrigger tool to stop and reassess antibiotic therapy

Targeted at all providers for Med/Surg patients

• Diagnosis: Does the patient have a bacterial diagnosis that requires antibiotics?

• Drug: Do I have the right drug and dose? (Covering the bug? Can I change to PO/narrower spectrum?)

• Duration: How long do the guidelines recommend treating?

• Documentation: Have I documented my plan clearly?

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Steps in an antibiotic time out include:

A. Re-evaluating patients who received antibiotics for over 48 hrs

B. Continuing therapy for over 72 hrs if not consistent with

infection

C. Not including stop dates in MR for patients on therapy over 72

hrs

D. De-escalating therapy based on culture results for patients on

antibiotics more than 72 hrs

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Quick Poll

Tracking & Reporting

Measurement

Clinical

• Length of stay

• Clinical cure/failure rates

• Readmission rates (30 days)

• Resistance rates

• Infection-related mortality

• C. Difficile infections

Process

• Dose optimization

• Adherence to hospital specific guidelines

• Appropriate de-escalation/streamlining

• Appropriateness of therapy

• Cultures before antibiotics

Humanistic

• Adverse drug events avoided

• Time to receipt of appropriate antimicrobials

• Duration of antimicrobial therapy

• IV/PO conversion rates

• Outpatient intravenous therapy rates

Economic

• Antimicrobial utilization (DDD or DOT)

• Hospital wide antimicrobial expenditures

• Relative consumption

• Rate of intravenous antimicrobial use

• Nonformulary agents avoided

Outcomes

DDD=Defined daily doseDOT=Days of therapy

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Utilization - DOT and CostPatient Days of Therapy

• 1 DOT is the administration of at least one dose of a single

agent on a given day

• 1 DOT represents the administration of a single agent on a

given day regardless of the number of doses or strength

• Can be used in pediatrics

• Insensitive to renal function and dosage; simply one day of

exposure

• Can be adjusted to hospital census

Example: Vancomycin 1 gram every 12 hours x 5 days = 5 DOT

A Story of Success

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ASP Implementation

Spring 2015

July 2015

Aug. 2015

Sept. 2015

Planning begins

P&T approves

system-wide ASP sub-

committee

1st formal ASP

committee meeting

Began C. diff. Process

Improvement Plan

Hospital-Onset C. diff. Rate

8.1

10.9

13.8

10.2

13.1 13.8

7.6

10.7

2.3

6.4

19.4

0

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4

6

8

10

12

14

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20

1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 1st Qtr 2nd Qtr 3rd Qtr

2013 2014 2015

HO

CD

I / 1

0,0

00

Pt

Day

s

11.2 HO CDI / 10,000 Pt Days = NHNS Benchmark

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Process for Improvement• Approval of system-wide CPOE order set

• Restriction of oral vancomycin

• Automatic therapeutic interchange

• Encourage antimicrobial streamlining

• Education in various forms to all involved parties

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Clinical Definition Supportive Clinical Data Recommended Treatment

Initial Episode, Mild / Moderate

WBC ≤ 15 x 103 μLAND

SCr < 1.5 x premorbid levelMetronidazole 500 mg PO TID x 10 days

Initial Episode, Severe

WBC > 15 x 103 μLOR

SCr > 1.5 x premorbid levelVancomycin 125 mg PO QID x 10 days

Initial Episode,Severe / Complicated

Meets criteria for severe initial episodeAND

Hypotension / shock, ileus, or megacolon

Metronidazole 500 mg IV TIDPLUS

Vancomycin 500 mg PO QIDx 10 days

(If ileus, may consider PR vancomycin)

1st Recurrence - Same as Initial Episode

> 1st Recurrence -

Vancomycin 125 mg PO QID x 14 daysTHEN

“Taper & Pulse” with Vancomycin 125 mg PO BID x 7 days

FOLLOWED BYVancomycin 125 mg QOD x 6 weeks

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7.2

8.6

6.3

4

5.1

0

2

4

6

8

10

12

14

16

18

20

4th Qtr 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

HO

CD

I / 1

0,0

00

Pt

Day

s

2015 2016

11.2 HO CDI / 10,000 Pt Days = NHNS Benchmark

Key Takeaways

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Key Takeaways

• CMS and TJC are developing guidance for

accreditation related to demonstrating an effective ASP, including developing publicly reportable measures

• Antimicrobial resistance is an urgent public health and patient safety concern

• Know your local epidemiology

• All stakeholders need to be engaged across the continuum of care, including consumers

CMS=Centers for Medicare and Medicaid ServicesTJC=The Joint Commission

Questions?

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Date post:	22-Jan-2018
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