the role of antimicrobial stewardship in decreasing...the role of antimicrobial stewardship in...

The Role of Antimicrobial

Stewardship in Decreasing

Clostridium Difficile Infections

Hospital Council of Northern and Central California June 28, 2013

Kavita K. Trivedi, MD Lead, California Antimicrobial Stewardship Program Initiative

Healthcare Associated Infections Program

California Department of Public Health

Outline

• Rationale for Improved Antimicrobial Use

• Regulatory Messages, Mandates and

Quality Measures

• Antimicrobial Stewardship Program

Implementation

• How Antimicrobial Stewardship can

Decrease Clostridium difficile infections

2

Rationale for Improved

Antimicrobial Use

3

30% of antimicrobial

use in acute care is

either inappropriate or

suboptimal

Cosgrove, SE, SK Seo, MK Bolon, et al. Infection Control and Hospital

Epidemiology , Vol. 33, No. 4, Special Topic Issue: Antimicrobial Stewardship (April

2012), pp. 374-380. 4

5

Rationale for Antimicrobial Use

Optimization

• Antimicrobial resistance

– Inherent

– Antimicrobial exposure

• Patient safety

– Arrhythmias, rhabdomyolysis, nephrotoxicity,

Clostridium difficile infections, death

• Cost

– Unnecessary use, switching from IV to PO,

broad-spectrum to pathogen-directed therapy

6


Optimization


– Inherent


• Patient safety



• Cost



7 7 © SHEA, 2011

“The time may come

when penicillin can be

bought by anyone in the

shops. Then there is the

danger that the ignorant

man may easily under

dose himself and, by

exposing his microbes to

non-lethal quantities of

the drug, educate them to

resist penicillin.”

Nobel lecture, 1945

Sir Alexander Fleming

Patel, Rasheed, Kitchel. 2009. Clin Micro News

CDC, unpublished data

DC

PR

AK

HI

Geographical Distribution of Carbapenemase-producing Enterobacteriaceae

November 2006

Patel, Rasheed, Kitchel. 2009. Clin Micro News

MMWR MMWR Morb Mortal Wkly Rep. 2010 Jun 25;59(24):750.

MMWR Morb Mortal Wkly Rep. 2010 Sep 24;59(37):1212.

CDC, unpublished data

DC

PR AK

HI

Geographical Distribution of Carbapenemase-producing Enterobacteriaceae

February 2013

10


Optimization


– Inherent


• Patient safety



• Cost



11

National Injury Surveillance

System (2004-2006)

• ED visits for antibiotic-related adverse effects

– Estimated 142,000 per year (116K-168K)

– Most prescriptions for URI, COPD, Otitis media and

sinusitis

– 78% due to allergic reactions (PCN)

– Sulfas – highest rate of serious allergic reactions

– 50% overall due to Sulfas and Clindamycin

– Sulfas and quinolones associated with highest rate of

neurological events

Shehab et al., CID 2008:47-735-43

12


Optimization


– Inherent


• Patient safety



• Cost



Cost of Antimicrobial-Resistant

Infections (ARI)

All Patients Patients with

ARI

Patients

without ARI

n (%) 1391 188 (13.5) 1203 (86.5)

APACHE II score 42.1 54.8* 40.1*

LOS (days) 10.2 24.2* 8.0*

HAI (n) 260 135* 125*

Cost per day ($) 1651 2098* 1581*

Total cost ($) 19,267 58,029* 13,210*

Death [n (%)] 70 34 (18.1)* 36 (3.0)*

*p<0.001

Roberts RR, et al. CID 2009;49: 1175-1184

Antimicrobial Approvals

The Pipeline is Dry

• Only 15-16 antibiotics are in development

• Only 8 of these have activity against key

Gram negative bacteria

• None have activity against bacteria

resistant to all current drugs

Boucher HW et al. Clin Infect Dis 2009; 48:1–12

European Centre for Disease Prevention and Control/European Medicines Agency

Joint Technical Report

http://www.emea.europa.eu/pdfs/human/antimicrobial_resistance/EMEA-576176-2009.pdf

16

Antimicrobial Use Optimization

• Widely accepted in acute care settings*:

– Improve antimicrobial resistance patterns

– Decrease patient toxicity

– Decrease costs

• Limited literature and few studies in LTCFs

– Efforts are necessary**

*SHEA/IDSA Guidelines, CID 2007 Jan;44(2):159-77

**Schwartz, DN et al., J Am Geriatr Soc 2007;55:1236-1242

Regulatory Messages,

Mandates and Quality

Measures

17

California Senate Bill 739

• Health & Safety Code §§ 1288.5 to 1288.9 (2006)

• Established Healthcare Associated Infections (HAI) Program at CDPH

– HAI surveillance, prevention and annual reporting in all general acute care hospitals

• Mandatory public reporting of process measures

– CLIP, SCIP, and influenza vaccination

• Later legislation mandated HAI-specific public reporting (2008)

http://www.dhcs.ca.gov/provgovpart/initiatives/nqi/Documents/SB739.pdf 18

California SB 739

“By January 1, 2008, [CDPH] shall take all of the

following actions to protect against health care

associated infections (HAI) in general acute care

hospitals statewide:

– (4) Require that general acute care hospitals develop

a process for evaluating the judicious use of

antibiotics, the results of which shall be monitored

jointly by appropriate representatives and committees

involved in quality improvement activities.”

Health & Safety Code § 1288.8(a)

http://www.dhcs.ca.gov/provgovpart/initiatives/nqi/Documents/SB739.pdf 19

What does §1288.8(a)(4) mean to

the HAI Program?

• Each California acute care hospital should

have an Antimicrobial Stewardship

Program (ASP)

– California is the only state with this type of

legislation

20

21 21

Antimicrobial Stewardship

Program (ASP)

• Promotes appropriate use of antimicrobials by selecting the appropriate agent, dose, duration and route of administration

• Objective:

– Optimize the utilization of antimicrobial agents in order to:

• Minimize acquired resistance

• Improve patient outcomes and toxicity

• Reduce treatment costs

22

CDPH Licensing and

Certification Surveys

• To determine compliance of CA acute-care

hospitals with SB 739:

– How do you monitor the judicious use of antibiotics?

– Do you have a policy and procedure on the judicious

use of antibiotics?

– What committees review and approve the policy on

the judicious use of antibiotics?

– Who monitors the judicious use of antibiotics and

prepares reports on the monitoring?

http://www.cdph.ca.gov/programs/LnC/Documents/PSLS-Process-Tool-for-Providers-03-01-11.pdf

National Quality Forum

• Core Measures

– Pneumonia: Optimize empiric antibiotic therapy

– Surgical Care Infection Prevention (SCIP):

Right drug, right dose, right duration

– Proposed measure under discussion to include

antimicrobial utilization measurement

The Joint Commission

• National Patient Safety Goal 07.03.01

– Implement evidence-based practices to

prevent HAIs due to MDROs in acute care

hospitals

– Defines process interventions and outcomes

measurements

24

CMS Inpatient Infection

Control Worksheet • Used by surveyors to ensure compliance

with CMS Conditions of Participation

• Includes quality measures on antibiotic

use in “Section 1: Systems to prevent

transmission of MDROs and promote

antibiotic stewardship, Surveillance”

http://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-03.pdf 25

Antibiotic Use Quality Measures

on CMS IC Worksheet

1.C.3.a Facility has a multidisciplinary process in

place to review antimicrobial utilization, local

susceptibility patterns and antimicrobial agents

in the formulary and there is evidence that the

process is followed.

• C.3.b Systems are in place to prompt clinicians

to use appropriate antimicrobial agents (e.g.

CPOE, comments in microbiology susceptibility

reports, notifications from clinical pharmacist,

formulary restrictions, evidence based

guidelines and recommendations) 26

Antibiotic Use Quality Measures

on CMS IC Worksheet

1. C.3.c Antibiotic orders include an

indication for use.

• C.3.d There is a mechanism in place to

prompt clinicians to review antibiotic

courses of therapy after 72 hours of

treatment.

• C.3.e The facility has a system in place to

identify patients currently receiving IV

antibiotics who might be eligible to receive

PO treatment.

27

CMS Inpatient Infection

Control Worksheet • Not “citation level” events

• Not currently part of CMS Conditions of

Participation

• For quality improvement

28

ASP Implementation

29

Acute Care Hospitals and

ASP Implementation

• Many have developed ASPs due to:

– Increasing prevalence of HAIs coupled with

decreased reimbursement and public

reporting

– Lack of new antimicrobials under

development

30

Jump RLP, DM. Olds, N Seifi, et al. Infection Control and Hospital

Epidemiology , Vol. 33, No. 12 (December 2012), pp. 1185-1192

31 31

Antimicrobial Movement in the

Healthcare Setting

Patient Evaluation

Choice of Antimicrobial

Prescription Ordering

Dispensing Antimicrobial

32 32

ASP Strategies

Patient Evaluation

Choice of Antimicrobial

Prescription Ordering

Dispensing Antimicrobial

• Education/Guideline

• Formulary Restriction

and Pre-authorization

• Computer-assisted

strategies

• Review and Feedback

• Education/Guideline

• Formulary Restriction

and Pre-authorization

• Computer-assisted

strategies

• Review and Feedback

33 33

ASP Strategy Selection

• Facility dependent

– Beds and acuity of care

– Dedicated personnel

– Funds

– Pharmacy support

– Electronic systems

– Laboratory support

34

Patient Safety

Microbiology

P&T Committee

Pharmacy

Hospital

Leadership

Infection Control

Department

Infectious Diseases Division

Director, Information

Systems

Antimicrobial

Stewardship

Program

Clostridium difficile

Infection (CDI) and ASPs

35

C. difficile Incidence and

Mortality Are Increasing

36

0

5

10

15

20

25

0

10

20

30

40

50

60

70

80

90

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Principal Diagnosis All Diagnoses Mortality

Elixhauser A, et al. Healthcare Cost and Utilization Project: Statistical Brief #50. April 2008. Available

at: http://www.hcup-us.ahrq.gov/reports/statbriefs/sb50.pdf. Accessed March 10, 2010.

Redelings MD, et al. Emerg Infect Dis. 2007;13:1417-1419.

No

. o

f C

DI C

ase

s p

er

10

,00

0 D

isch

arg

es

An

nu

al C

D-re

late

d M

orta

lity R

ate

pe

r

Millio

n P

op

ula

tion

Estimated burden of

Healthcare-Associated CDI • Hospital-acquired, hospital-onset:

165,000 cases, $1.3 billion in excess costs, and 9,000 deaths annually

• Hospital-acquired, post-discharge (up to 4 weeks): 50,000 cases, $0.3 billion in excess costs, and 3,000 deaths annually

• Nursing home-onset: 263,000 cases, $2.2 billion in excess costs, and 16,500 deaths annually

Campbell et al. Infect Control Hosp Epidemiol.

2009:30:523-33.

Dubberke et al. Emerg Infect Dis. 2008;14:1031-

8.

Dubberke et al. Clin Infect Dis. 2008;46:497-504.

37

Nu

mb

er

of

ho

sp

ital

dis

ch

arg

es

Year Elixhauser, A. (AHRQ), and Jhung, MA. (Centers for

Disease Control and Prevention). Clostridium Difficile-

Associated Disease in U.S. Hospitals, 1993–2005.

HCUP Statistical Brief #50. April 2008. Agency for

Healthcare Research and Quality, Rockville, MD. And

unpublished data.

Antibiotic misuse adversely

impacts patients - C. difficile • Antibiotic exposure is the single most

important risk factor for the development

of Clostridium difficile associated disease

(CDAD)

• Up to 85% of patients with CDAD have

antibiotic exposure in the 28 days before

infection

38 Chang HT et al. Infect Control Hosp Epidemiol 2007; 28:926–931.

Antibiotic misuse adversely

impacts patients - C. difficile • Emergence of the NAP-1/BI or “epidemic”

strain of C. difficile has intensified the risks

associated with antibiotic exposure

– This strain is resistant to fluoroquinolones,

which confers a selective advantage.

– Associated with increased risk of morbidity

and mortality

39 McDonald LC et al. New England Journal of Medicine 2005;353:2433-41

Unnecessary Antimicrobial

Use in Current or Recent CDI • Up to 20% of CDI patients will have a recurrence

• At MN VAMC – 246 patients with new-onset

CDI, 57% received additional antibiotics during

CDI treatment

– Antimicrobials assessed for appropriateness:

• 26% unnecessary totaling 45% non-CDI antimicrobial days

• Providers should be more cautious with treating

recent CDI patients with antibiotics due to

increased risk of recurrence

40

Shaughnessy, MK, WH Amundson, MA Kuskowski et al.;Infection Control and

Hospital Epidemiology, Vol. 34, No. 2 (February 2013), pp. 109-

116

Impact of Fluoroquinolone

Restriction on Rates of Hospital-

Onset C. difficile Infection

41

0

0.5

1

1.5

2

2.5

HO

-CD

AD

cases/1

,000 p

d

Month and Year

Infect Control Hosp Epidemiol. 2009 Mar;30(3):264-72.

2005 2006 2007

ASP Can Make a Difference with

Hospital-Associated CDI

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

Valiquette, et al. Clin Infect Dis 2007;45:S112. 42

Conclusions

• Antimicrobial resistance is increasing –

especially in HAIs

• Antimicrobial stewardship programs can

improve antimicrobial use and decrease

development of resistance

• Hospital-onset and hospital-associated

CDI is also on the rise

– Antimicrobial stewardship strategies can

decrease rate of CDI

43

45 45

Keep ASPs in Perspective…

• Minimizing antimicrobial resistance:

– ASP

– Infection control

– Environmental services

Questions

Kavita K. Trivedi, MD

Healthcare Associated Infections Program

Center for Health Care Quality

California Department of Public Health

850 Marina Bay Parkway

Richmond, CA 94804

[email protected]

46

mailto:[email protected]