JARRETT R. AMSDEN, PHARMD, BCPS ASSOCIATE PROFESSOR BUTLER UNIVERSITY COPHS INFECTIOUS CLINICAL...

JARRETT R . AMSDEN, PHARMD, BCPSASSOCIATE PROFESSOR

BUTLER UNIVERSITY COPHS&

INFECTIOUS CLINICAL SPECIALIST COMMUNITY HEALTH NETWORK

CO -CHAIR OF THE COMMUNITY HEALTH NETWORK ANTIMICROBIAL STEWARDSHIP

PROGRAM

Antibiotic Stewardship in Nursing Homes – What is it, what are your

roles and opportunities?

Objectives

1. Review and discuss antibiotic stewardship (ASP) and its application to nursing homes

2. Identify opportunities for ASP across a broad setting or an individual LTCF site

3. Discuss how to devise a process, identify each person’s role in the process and implement the process

4. Discuss methods of evaluating and revising the process during the pilot stages

Disclosure: I have no financial or commercial conflicts of interest

Antimicrobial Stewardship

“the optimal selection, dosage, and duration of antimicrobial treatment that results in the best

clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent

resistance.”

Missing is the appropriate diagnosis of the infection for which the antibiotic is

prescribed

Clin Infect Dis. 2007;44(2):159-177

Baseline Assessment Question

The antibiotic choice Is there a best choice for a patient?

Yes How would you characterize this choice?

After allergies, the most narrow spectrum and most likely to promote adherence

Is there a best dose for a patient and/or infection? Yes, it is in the drugs pharmacodynamics???

Is there an optimal duration for this infection Yes and No Yes there is, but in some circumstances it is less clear

and/or hard to define

Why is Antimicrobial Stewardship Important?

70% of LTCF residents receive an antimicrobial course annually

40-75% of these antimicrobial courses is inappropriate

Overexposure to antibiotics leads to: Resistance Collateral infections – C. difficile Adverse events Drug interactions Multidrug-resistant organism colonization and

transmission

Clin Infect Dis. 2007;44(2):159-177; JAMA 2003;289: 1107–11; Infect Control Hosp Epidemiol 2000; 21:537–45

Why is Antimicrobial Stewardship Important?

Prevention •National ASP implementation could prevent 619,000 infections over 5 years

National Action Plan •Calls for developing ASP in LTCFs•Expanding, developing and monitoring programs

CMS •Will include infection control, ASP and antibiotic monitoring in their forthcoming LTCF requirements

CDC •Developed “Core Elements” for ASP in LTCFs

JAMDA 2016;183.e1-183.e16

Approaches to ASP

The “Front-end” The “Back-end”

Process that occurs pre-prescription –(RESTRICTION) Employ tactics that

limit what can be prescribed and by whom

Process that occurs post-prescription – (Prospective audit and feedback) Provides

recommendations on antibiotic selection, dose and duration


Clin Infect Dis. 2007;44(2):159-177

The “Front-end” Methods

The “Back-end” Methods

Education and Transparency

Formulary restriction or approvals

Order-sets or pathways

GuidelinesDose optimizationDecision support

tools

Education and Transparency

GuidelinesDe-escalationDuplicationDurationDose optimization IV to PO


Clin Infect Dis. 2007;44(2):159-177

The “Front-end” Methods

The “Back-end” Methods

PROs Target antibiotic utilization issues Encourage formulary adherence Decrease costs Necessary during outbreaks

CONs Questionable effect on resistance Compromises prescriber

autonomy Variability in who staffs the

process/resources Application across facilities is

challenging Loopholes in the programs

PROs Direct caregiver interactions Trained individuals making

recs? Interventions can be tailored

CONs Requires persistent

monitoring and time Training and competency Personnel and resources Continuous feedback


Clin Infect Dis. 2007;44(2):159-177


How to get it going Assess your current resources Identify and determine areas of need Get “top-down” buy-in Develop a plan or business plan pending resources Put it into action Measure and re-assess or re-adjust

Barriers Resources and priorities Provider and personnel acceptance Direct causality of your efforts Keeping the fire lit

Clin Infect Dis. 2007;44(2):159-177

Building a Multidisciplinary Team

Antimicrobial

Stewardship

Admin Support

ID Physicianor

Physician Champion

ID-trained Pharmacist

NursingInfection Prevention

Micro

Information Technology

Clin Infect Dis. 2007;44(2):159-177

Measuring Success

Metrics Defined Daily Dose (DDD) – Antibiotic consumption

The DDD is calculated as the total number of grams of antimicrobial agent used divided by the number of grams in an average daily dose

Day of Therapy (DOT) – Clinical antibiotic use DOTs are expressed as the administration of a single agent

on a given day regardless of the number of doses administered or dosage strength

Resistance rates via the antibiogram or infection control Incidence of resistant or problematic organisms Number/percentage of successful interventions or

prescriptions considered appropriate

Clin Infect Dis. 2007;44(2):159-177

APPLICATIONS TO LONG-TERM CARE FACILITIES

Antibiotic Stewardship

Optimal Care in LTCF – an upward climb

LTCFs house 50-200 residents per facility Average staffing per 100

resident beds 7 RNs 13 LPNs 35 CNAs

< 20% have fulltime physician providers

Statutes for staffing vary by state

Guidelines for staffing ratios CNAs to residents > 1:12 RNs + LPNs to residents >

1:30 RNs to residents > 1:120

Indiana Staffing Minimums Nursing

1DON RN full-time included in 1 RN 8 consecutive

hours/7days/wk and 1 LPN Charge Nurse each shift

For 1-60 resident: DON may be Charge Nurse included in: RN/LPN RATIO

0.5 LPN hour per resident day to resident ratio (averaged over 1 week, excluding DON)

Physician – in person Must see a resident at least once

every 30 days for the first 90 days

Then at least every (60) days thereafter

Alternating visits by PA, NP, etc. are acceptable

Infections in elderly – the challenges

Higher incidence of infection Lower barriers to infection (skin, immune deficits,

etc.)More indwelling devicesComorbid conditions Elderly patients tend to:

Have poor localization of or atypical “text book” symptoms

Inability to demonstrate physical declines Inability to communicate physical or mental changes Changes are often slow or too subtle to be detected

Detecting an overall functional decline is the key

Suspecting infections in LTCF patients

Defining a declining functional status New onset or increase in:

Confusion Incontinence Falling Decreasing mobility Decreasing food intake Failure to cooperate with staff

High KP, et al. Clin Infect Dis 2009;48:149-171

Suspecting infections in LTCF patients

Fever Elderly have lower basal body temperatures Defining fever as 100°F (37.8°C) had a sensitivity of

70% and specificity of 90% for detecting infectionAccepted criteria for defining fever in LTCFs

Single temperature of 100°F (37.8°C) Repeated temperatures of > 99°F (37.2°C) orally or >

99.5°F (37.5°C) rectally 2°F (1.1°C) increase in temperature above baseline


The Patient Assessment

1st Layer CNAs measuring the resident vital signs and clinical symptoms

Must convey the possibility of a fever and symptoms to LPN/RN2nd Layer

LPN/RN should corroborate these findings and conduct a complete resident examination and document the critical findings This examination and documentation is vital to communication to the

physician or physician extender3rd Layer

LPN/RN to call physician or physician extender with COMPLETE list of findings Ideally the provider should facilitate the evaluation over the phone and

order directed tests/labs as able and necessary to make appropriate clinical decisions

Conduct their own patient assessment/evaluation at the next time point


Laboratory Testing for Infection

CBC with differential within 24 hours WBC > 14,000 cells/mm3 (LR 3.7), > 90% neutrophils

(LR 7.5), bands > 6% (LR 4.7) are potential indicators of infection If normal, this may limit further testing needs

BMP While not needed for infectious sources it may be

useful for establishing or ruling out metabolic causes May aid with optimal drug dosing



UTIs Incidence 0.1-2.4 cases/1000 resident days Patients with indwelling catheters will almost always have

WBCs and bacteriuria, but this is rarely indicative of a UTIUrinalysis +/- Culture

MUST have symptoms to support testing Must define symptoms for those catheterized vs non-catheterized

10-50% of institutionalized patients will have asymptomatic bacteriuria Absence of WBC in the urine or negative leukocyte esterase and

nitrite in a dipstick test can be used to rule-out bacteriuria If a patient has a chronic indwelling catheter this should be

changed before culturing



Bacteremia Bacteremia occurs in 5-40/100,000 resident days Secondary bacteremia occurs in 6% of patients

~50% from urinary tract ~10% from respiratory tract and skin or soft tissue ~5% from abdominal source ~3% from IV catheters ~20% unidentified sources

Blood cultures Generally low yield in elderly patients Symptoms of bacteremia are less obvious the elderly and are

frequently associated with other organ system issues Necessary in patients where bacteremia or urosepsis is

suspected



Pneumonia Common source of infection with high mortality in LTCF patients

Monitoring and imaging RR > 25 breaths/min and SAO2 < 90% are strong predictors of potential

respiratory failure SAO2 < 94% had 80% sensitivity, specificity 91% and PPV 95% for

diagnosing pneumonia CXR can be helpful to determine origin of hypoxemia Sputum specimens can be o potential value, but are low yielding –

mixed flora in >35% of cases Urine antigen testing for S. pneumoniae or L. pneumophila are limited

by sensitivity, but potentially useful for early detection Rapid influenza testing may identify the index case and reduce

outbreaks Multiplex panels can detect other viruses including RSV – treatment is

limited



Skin and Skin structure infections (SSTIs) 3rd most common infectious etiology – 1-9% (0.9-2.1

cases/1000 resident days Most common infections

Cellulitis Pressure ulcers Scabies

Obtaining culture specimens Do not perform superficial swab cultures Areas of discrete abscess or deep tissue specimens in

select circumstances can be used to direct therapy



Gastrointestinal 1/3 of LTCF residents will have an episode of diarrhea annually 1/3 of deaths attributed to diarrheal causes are in LTCF residents > 74

years 3 or more unformed, loose stools for > 48 hours

C. difficile Most common identifiable cause of diarrhea in LTCF 3 or more loose, watery (often explosive) stools in 24 hours

When using PCR testing, this is often combined with clinical criterion Rates of asymptomatic carriage range from 10-30%

Carriers can transmit disease Highly susceptible to antibiotic flora disruptions

New diagnostic tests and/or algorithms with older tests have improved sensitivity and specificity Use of PCR tests may increase rate of false positive tests due to detecting

carriers



Gastrointestinal Illnesses of the small bowel can be watched for 7 days with

volume assessment provided that Not in an outbreak setting Clinically stable Symptoms do not persist past 7 days

Persistent symptoms, but clinically stable should have the stool checked for O&P

Colitis is associated with fever, abdominal cramps, diarrhea w/ or w/o blood, and/or WBCs in the stool Patients exposed to antibiotics in the past 30 days

C. difficile Patients not exposed to antibiotics or with a negative C. difficile

test Enteric pathogens – Salmonella, Shigella, Ecoli O157:h7


STONE ND, ET AL . SURVEILLANCE DEFINITIONS OF INFECTIONS IN LONG-

TERM CARE FACILITIES: REVISITING THE MCGREER CRITERIA.

INFECT CONTROL HOSP EPIDEMIOL 2012 ;33(10) :965-977

The McGreer Criteria


Criteria developed to help define infections in LTCFs that are likely to be true infections

These definitions may not be adequate for real-time case finding, diagnosis, clinical decision making - antibiotic selection

Definitions are aligned with the IDSA criteria for evaluating fever in LTCF residents

Criteria for using these definitions All symptoms must be new or acutely worse Consider and evaluate non-infectious etiologies before calling

this an infection Identification of infection MUST be based upon multiple pieces

of data

Stone ND, et al. Infect Control Hosp Epidemiol 2012;33(10):965-977


Elements of the McGreer Criteria may provide a more complete definition for assessment criteria Definitions for acute changes in mental and/or

functional status Uses a more objective ADL scale for functional declines

Common cold/pharyngitis signs and symptomsElements may be to stringent at the clinical

decision point UTIs must have microbiological confirmation GI illness definitions of diarrhea are uniform for C.

difficile vs non-C. difficile infectionsStone ND, et al. Infect Control Hosp Epidemiol 2012;33(10):965-977

Evaluation of Fever (Loeb)

Surveillance of Infections (McGreer)

Screening criteria Less detailed criteria

to allow decision to order tests or prescribe therapies

Intended to help guide antibiotic prescribing (prospective)

Documenting criteria More detailed criteria to

enhance infection identification

Intended to define if an infection is present and could be used to determine antibiotic appropriateness (quasi-prospective , mostly retrospective)

Loeb vs. McGreer

Similar infections and basic definitions

High KP, et al. Clin Infect Dis 2009;48:149-171Stone ND, et al. Infect Control Hosp Epidemiol 2012;33(10):965-977

AMDA PRESS RELEASE WITH HYPERLINKS TO CDC:HTTP: / /

WWW.AMDA.COM/NEWS/RELEASES /2015 /CDC%20RELEASES%20CORE%20ELEMENTS%20FOR%20NHS.PDF

PRIMARY CDC SITE :HTTP: / /

WWW.CDC.GOV/LONGTERMCARE/ PREVENTION/ANTIBIOTIC- STEWARDSHIP.HTML

MORRILL HJ, ET AL . JAMDA 17 (2016) ;183 .E1 -183 .E16

AMDA and CDC Antimicrobial Stewardship

Core Elements

http://www.amda.com/news/releases/2015/CDC%20Releases%20Core%20Elements%20for%20NHs.pdf





http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html



AMDA and CDC Process

• Support and commit to appropriate antibiotic useLeadership Commitment

• Identify physician, nursing and pharmacy “leads” in and across facilitiesAccountability

• Access to antibiotic stewardship experts within facilitiesDrug expertise

• Implement at least one policy or practice to improve antibiotic useAction

• Monitor process measure of antibiotic use and outcomeTracking

• Provide feedback to providers, nursing staff and stakeholders Reporting

• Provide resources to staff, residents and familiesEducation

Antimicrobial Stewardship in LTCFs

There are only 14 published works on ASP interventions in LTCFs Noted needs for ASP

High rates of unnecessary antibiotic use Increased risk or prevalence of MDR organisms Increased risk for C. difficile

Noted barriers to ASP Lack of proven ASP strategies Lack of funding, resources and infrastructure at LTCF sites Diagnostic dilemmas and appropriate prescribing Lack of ID-trained physicians or pharmacists Resident and family expectations

Morrill HJ, et al. JAMDA 17 (2016);183.e1-183.e16

Selected Studies to Discuss


33 month prospective study in a 190 bed VA LTCF in proximity to an acute care hospital 3 months of monitoring practice habits followed by 30

months of data collection following an educational intervention

ResultsOutcome 3mo pre-intervention

6mo post-intervention

7-30mo post-intervention

Ur cx sent /1000 pt days 3.7 (2.8-4.9) 1.5 (1.1-2.1)* 1.3 (1.1-1.5)Inappropriate Ur cx /1000 pt days

2.6 (1.8-3.6) 0.9 (0.6-1.4)* 0.6 (0.5-0.8)*

ASB treated /1000 pt days

1.7 (1.1-2.6) 0.6 (0.4-1.0)* 0.3 (0.2-0.4)

Abx days /1000 pt days 167.7 117.4* 109*Ur= urine; cx=culture; pt=patient; ASB=asymptomatic bacteriuria; Abx=antibiotics; * indicates p<0.05 compared to pre-intervention periodZabarsky et al. Am J Infect Control.

2008;36:476-480


Retrospective cohort study of LTCF patients who received antibiotic therapy for suspected UTI Data from a 6 month period across 4 LTCF sites

Dependent variable: signs/symptoms of a UTI using the Loeb et al. criteria Independent variables: resident characteristics, site, etc.

Indwelling catheter patients were excluded from the primary analysis (n=16, #23 antibiotic Rx’s)

Results 56% were > 85 years, mean ADLH 2.0 (1.2), mean CPS 2.0 (0.6) 204 antibiotic courses for 151 residents (26% with multiple courses)

71-97% had urine studies and 64-85% of prescribers had the result prior to their antibiotic order

Mean duration of antibiotic therapy was 7.6 days vs 8.1 days for asymptomatic vs symptomatic patients, respectively (p=NS)

Multivariate analysis demonstrated that only the LTCF site impacted the likelihood of an antibiotic prescription for an asymptomatic UTI

Phillips CD, et al. BMC Geriatrics 2012;12:73


Prospective cluster randomized controlled study across 30 LTCFs evaluating the use of an ASP tool to direct antibiotic prescribing 15 NHs were stratified to the intervention tool and 15 as controls

Primary outcome measure is mean number of antibiotic prescriptions/100 residents (prevalence) and DDD/1000 residents (consumption)

Results Mean number of prescriptions was not significantly different

between groups in either period DDD/1000 residents was significantly decreased using the

intervention tool 4.9% (95%CI 1-8.6%, p=0.02) compared to a 5.1% increase (95% CI 0.2-10.2%, p-0.04)

100% compliance to the interventional tool was only 46% and 31% for parts A and B, respectively

Fleet E, et al. J Antimicrob Chemother 2014;69:2265-2273

JAMA 2014 ;312(16) :1687-1688

A case to ponder

UTI Case

PMH: 80-year-old female with 2-year history of 8 UTIs and 6 treated with

antibiotics (no catheter) History of falls, cognitive impairment and incontinencePrimary problem:

Increased confusion, urinary frequency, cloudy urine, lethargy, hallucinations and falls

HPI Family reports that she “doesn’t look right,” but the nursing staff

states she is not confused. The patient reports no dysuria or abdominal pain but does chronically

complain of voiding frequently. She is afebrile with no abdominal, suprapubic, or flank tenderness,

but her urine has a foul odor. Newly inserted catheterized urine was collected

JAMA 2014;312(16):1687-1688

UTI Case

Result Reference RangeColor Yellow, hazy YellowSpecific gravity 1.005 1.005-1.030pH 7.5 5-7.5Blood 1+ NegativeProtein Negative NegativeNitrite 1+ NegativeLeukocyte esterase 3+ NegativeBacteria 3+ None-few/hpfWhite blood cells 40-100/hpf 0-5/hpfRed blood cells 2/hpf 0-5/hpfEpithelial cells 0-5/lpf None-few/lpf

Culture: > 100,000 cfu/mL Ecoli – Only resistant to Ampicillin

JAMA 2014;312(16):1687-1688

UTI Case

How do you interpret these test results in the context of this patient case?

A. The patient has asymptomatic pyuria and bacteriuria.

B. The patient has a UTI due chronic incontinence and a positive urine culture.

C. A positive urinalysis and urine culture are always a UTI.

D. Since the patient has a history of recurrent UTIs, current urine test results are also indicative of an UTI.

JAMA 2014;312(16):1687-1688

Discussion Points

In adults >= 65 years or older, positive dipstick ((+ ) leukocyte esterase, nitrite,or both) for a urine culture with more than 100 000 CFU/mL Sensitivity: 65% - 100% Specificity:20% - 77% Positive predictive value(PPV): 31% - 45% Negative predictive value(NPV),90% - 100%

Positive likelihood ratio (LR+): 1.25 - 2.8 Negative likelihood ratio (LR−): 0 - 0.46.

Take home pointsPPV is too low to use to determine UTINPV is high enough to make the diagnosis of a UTI unlikely

JAMA 2014;312(16):1687-1688

Discussion Points

Urinalysis - > 10 WBCs/hpf is an accepted threshold for pyuria required for a UTI diagnosis > 10 WBCs/hpf in relation to a culture with > 100,000

CFU/mL Sensitivity: 78% Specificity: 63% PPV: 64% NPV: 74%

LR+: 2.11 LR−: 0.35.

Pyuria should only be used to confirm a clinical diagnosis of UTI (guided by signs and symptoms).

JAMA 2014;312(16):1687-1688

Does this patient have a UTI?

How do you interpret these test results?A. The patient has asymptomatic pyuria and

bacteriuria.B. The patient has a UTI due chronic incontinence

and a positive urine culture.C. A positive urinalysis and urine culture are

always a UTI.D. Since the patient has a history of recurrent

UTIs, current urine test results are also indicative of an UTI.

JAMA 2014;312(16):1687-1688

Does the patient have a UTI

The clinical criteria for symptomatic UTI in older women (no catheter) include 2 or more: Fever Worsened urinary urgency or frequency Acute dysuria Suprapubic tenderness Costovertebral angle pain or tenderness

Patient did not have these symptoms, so she was diagnosed with Asymptomatic pyuria and bacteruria

JAMA 2014;312(16):1687-1688

Opportunities and Roles in Antimicrobial Stewardship

Opportunities The opportunities are limitless Any intervention directed at a perceived or actual problem

will likely result in a benefit In time, these opportunities will soon be expectations so now

is the time to start thinking about these itemsRoles

It will vary by your role in the facility or process, but be pro-active

The AMDA and CDC core elements should offer you guidance on how and where you CAN or NEED to fit into this process

This needs to be multi-disciplinary, so tap your colleagues or anyone interested

Conclusions

Antibiotic stewardship is clearly needed in LTCFs The opportunities are vast and can be either self-identified or

identified by data gatheringASP processes are multi-disciplinary and interventions

should be multi-facetedGetting involved and using the CDC core elements is a startEducation needs to be directed to both nursing and

prescribers Evaluating the process needs to be based on the data that is

accessible and applicableRevising the process with feedback from the nursing staff

and providers is essentialTransparency of the process to residents, family and all

caregivers is a must

JARRETT R. AMSDEN, PHARMD, BCPS ASSOCIATE PROFESSOR BUTLER UNIVERSITY COPHS INFECTIOUS CLINICAL...

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