An Opportunity for Pharmacy Leadership Holly Maples PharmD Associate Professor Dept of Pharmacy Practiced Jeff amp Kathy Lewis Sanders Endowed Chair in Pediatrics UAMS College of Pharmacy ID: 740424
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Slide1
Antimicrobial Stewardship & Joint Commission Requirements:An Opportunity for Pharmacy Leadership
Holly Maples,
Pharm.D
.
Associate Professor,
Dept
of Pharmacy Practiced
Jeff & Kathy Lewis Sanders Endowed Chair in Pediatrics
UAMS College of Pharmacy
Director, Antimicrobial Stewardship
Director, Pediatric ID and Antimicrobial Stewardship Fellowship
Arkansas Children’s HospitalSlide2
Conflict of InterestDr. Maples has no conflict of interest to report pertaining to this talk.
This talk is
NOT
Slide3
ObjectivesDescribe
the eight elements of performance in the New Antimicrobial Stewardship Standard
Identify
specific antimicrobial stewardship strategies utilizing clinical pharmacists within your institution
Discuss
educational opportunities to enhance pharmacists skills in antimicrobial management
Describe
antimicrobial usage measurements
Identify
quality improvement opportunities within your institution and how to get it accomplishedSlide4
Antibiotic overuse
Leads to avoidable costs and toxicities
Disruption of the host
microbiome
Is the most important contributor to
antibiotic resistance
The White House has called for hospitals and healthcare systems to implement stewardship programs by 2020.
Reduce inappropriate
abx use by 50% in OP settingsReduce inappropriate abx use by 20% in IP settingsSlide5
CDC 2013 Report: Antibiotic Resistance Threats in the United States.Slide6
New Antimicrobial Stewardship Standard
Effective January 1, 2017
Hospitals have an antimicrobial stewardship program based on current scientific literature.Slide7
Elements of Performance (1)Leaders establish antimicrobial stewardship as an organizational priority
Accountability documents
Budget plans
Infection prevention plans
Performance improvement plans
Strategic plans
Using the EMR to collect antimicrobial stewardship dataSlide8
Elements of Performance (2)The hospital educates staff and licensed independent practitioners involved in antimicrobial ordering, dispensing, administration, and monitoring about antimicrobial resistance and antimicrobial stewardship practices. Education occurs upon hire or granting of initial privileges and periodically thereafter, based on organizational need.Slide9
Elements of Performance (3)The hospital educates patients, and their families as needed, regarding the appropriate use of antimicrobial medications, including antibiotics.
Education tool that can be used
CDC’s Get Smart document, “Viruses or Bacteria-What’s got you sick?” at
http://www.cdc.gov/getsmart/community/downloads/getsmart-chart.pdf
.Slide10
Elements of Performance (4)The hospital has an ASP multidisciplinary team that includes the following members, when available in the setting:
ID physician
Infection
preventionist
Pharmacist(s)
Practioner
Note 1
: Part-time or consultant staff are acceptable as members of the ASP multidisciplinary team
Note 2: Telehealth staff are acceptable as members of the ASP multidisciplinary teamSlide11
Elements of Performance (5)
The hospital’s ASP includes the following core elements (documentation required)
Leadership commitment
: Dedicating necessary human, financial, and IT resources
Accountability
: Appointing a single leader responsible for program outcomes.
Drug Expertise
: Appointing a single pharmacist leader responsible for working to improve antibiotic use
Action: Implementing recommended actions, such as systemic evaluation of ongoing treatment need, after a set period of initial treatment. (example, antibiotic time out after 48 hours)Tracking: Monitoring the antimicrobial stewardship program, which may include information on antibiotic prescribing and resistance patterns.Reporting: Regularly reporting information on the antimicrobial stewardship program, which may include information on abx use and resistance, to doctors, nurses, and relevant staffEducation: Educating practitioners, staff, and patients on the ASP, which may include information about resistance and optimal prescribing.Slide12
Elements of Performance (5)Core elements were cited from the CDC’s Core Elements of Hospital Antimicrobial Stewardship Programs (
http://www.cdc.gov/getsmart/healthcare/pdfs/core-elements.pdf
)
Joint Commission recommends that organizations use this document when designing their antimicrobial stewardship program.Slide13
Elements of Performance (6)
The hospital’s ASP uses organization-approved multidisciplinary protocols (example, policies and procedures) (documentation required)
Antimicrobial Formulary Restrictions
Assessment of Appropriateness of
Abx
for CAP
Assessment of Appropriateness of
Abx
for SSTI’sAssessment of Appropriateness of Abx for UTI’sCare of the Patient with C. diffGuidelines for Antimicrobial Use in AdultsGuidelines for Antimicrobial Use in PediatricsPlan for IV to PO conversionPreauthorization requirement for specific antimicrobialsUse of prophylactic antibioticsSlide14
Elements of Performance (7)The hospital collects, analyzes, and reports data on its ASP. (documentation required)
Note
: Examples of topics to collect and analyze data on may include evaluation of the ASP, antimicrobial prescribing patterns, and antimicrobial resistance patternsSlide15
Elements of Performance (8)The hospital takes action on improvement opportunities identified in its antimicrobial stewardship program. (documentation required)Slide16
New Stewardship Guidelines
Barlam
TF et al. CID 2016 April 13 (
Epub
ahead of print)Slide17
Key Points- Guideline Interventions
Combination of preauthorization
and
prospective review of antibiotics have shown to be most effective.
Barlam
TF et al. CID 2016 April 13 (
Epub
ahead of print
)Slide18
ACH Example: Pre-authorization of MeropenemSlide19
ACH Cefepime UsageSlide20
Key Points- Guideline Interventions
Combination of preauthorization
and
prospective review of antibiotics have shown to be most effective.
Stewardship programs should be led by physicians and pharmacists on equal levels.
Barlam
TF et al. CID 2016 April 13 (
Epub
ahead of print)Slide21
Key to Success: Multidisciplinary Involvement
Program Coordinators
ID physician
ID Pharm.D.
Clinical Pharmacy Specialists
Decentralized Pharmacy Specialists
Microbiology Lab
Medical Information Systems
Infection Control
Hospital Epidemiologist
Hospital Administrator
Infectious Disease Division
P & T Committee
Adapted from: Fishman NO. In: Principles and Practice of Infectious Diseases. 4
th
ed. 1995:539-46.Slide22
Education Opportunities for Pharmacists
ID Fellowships
ID Residency
Board Certification in IDCertificates MAD-ID (Making a Difference in Infectious Diseases)
SIDP (Society of Infectious Diseases Pharmacists)
Workshops
IDSA (Infectious Diseases Society of America)
SHEA (Society of Healthcare Epidemiology of America)Slide23
Key Points- Guideline Interventions
Combination of preauthorization
and
prospective review of antibiotics have shown to be most effective.
Stewardship programs should be led by physicians and pharmacists on equal levels.
Interventions should be focused at institution level.
Barlam
TF et al. CID 2016 April
13 (Epub ahead of print) Slide24Slide25
ACH Top 20 AntibioticsSlide26
Key Points- Guideline Interventions
Combination of preauthorization
and
prospective review of antibiotics have shown to be most effective.
Stewardship programs should be led by physicians and pharmacists on equal levels.
Interventions should be focused at institution level.
Direct input from stewardship team will improve prescriber led review of appropriateness of Antibiotic regimens.
Barlam
TF et al. CID 2016 April 13 (Epub ahead of print)Slide27
5 D’s of Antimicrobial StewardshipSlide28
5 D’s of Antimicrobial Stewardship
Ensuring a diagnosis or indication is established to direct antibiotic therapy
Consistency amongst prescribers in diagnosis
Rapid DiagnosticsSlide29
Variation in Antibiotic Prescribing Across a Pediatric Primary Care Network
Jeffrey Gerber,
Priya
Prasad, Russell
Localio
et al.
J
Ped
Infect Dis 2015;4(4):297-304Abx are the most common Rx drug given to childrenOutpatient ARTI’s account for the majority of these Rx’s
Inappropriate
Abx
prescribing for viral infections has decreased over time while broad spectrum
Abx
usage has increased.
AAP
supports treatment of most ARTI’s with narrow spectrum antibiotics
Current studies lack detailed, patient specific clinical data, including: comorbid conditions, drug allergies, and prior
abx
use along with the ability to compare prescribing across practitioners and practice groups.Slide30
Purpose
Compare management of common pediatric infections across practices to generate
benchmarking data and
help to define high-impact targets for intervention
Time/Place:
Jan 1-Dec 31 2009
pediatric
healthcare network that included 29 primary care pediatric practice sites staffed by 222 pediatric
practitioners
who share a comprehensive EHR.
Outcome Measures
Abx
prescriptions
Broad-spectrum prescriptions
Encounter diagnosis based on ICD-9 codeSlide31
Data AnalysisTotal of 102,102 prescriptions evaluated
59,259 narrow spectrum
42,843 broad spectrum
9597 had an abx allergy
3611 prior
abx
29,635 broad spectrum prescriptions evaluated
Between the 29 clinics a
significant difference was found between the clinics for abx usage for sick visits:All Abx (Range of 18-36%; P<.001)Broad spectrum Abx (Range of 15 -57%; P<.001)All Abx for otitis media (Range 8-20%; P<.
001)
Broad spectrum
Abx
for otitis media (
Range 18-60%; P<.
001)
Others (sinusitis, streptococcal pharyngitis, pneumonia)
Just not UTI
….why?Slide32
Conclusions
Wide variation in diagnosis and management
behaviors
, despite adjustment through exclusion and regression for patient clinical and demographic factors.
Stewardship interventions can now target specific practices, providers, and conditionsSlide33
5 D’s of Antimicrobial Stewardship
Empiric choice
Antibiogram
De-escalate
Narrowest spectrum
Allergies
Are they real?
Duplicate therapy
Know MOAKnow coverageSlide34
Predictors of Increased Mortality with Bloodstream Infections
Lodise TP et al. found for patients with Pseudomonas bloodstream infections they had an
↑ 30 day mortality if therapy delayed for > 52 hours by 44%.
Tumbarello
M et al. found for patients with an ESBL producing
Enterobacteriacea
a 3-fold increase in mortality compared to an initial adequately treated group.
21 Day mortality rate of 59.5% compared to 18.5%
Lodise TP et al.
Antimicrob
Agents
Chemother
2007;51:3510-15
Tumbarello
M et al.
Antimicrob
Agents
Chemother
2007;51:1987-94Slide35
CVICU Gram Negative Antibiogram 2014-2015Slide36
NICU Gram Negative
Antibiogram
2013-2014
Percentage of Susceptible IsolatesSlide37
Total Antibiotic NICU DataSlide38
Broad Spectrum
FY08
FY09
FY10
FY11
FY12
FY13
FY14
FY15
Cefepime
32.35
28.75
28.83
36.17
44.21
42.93
50.91
52.96
Ciprofloxacin
2.12
2.83
2.57
2.01
2.48
2.55
2.81
1.28
Daptomycin
1.36
0.71
0.28
0.87
1.36
1.64
1.31
1.65
Levofloxacin
7.35
11.86
6.16
4.87
2.78
3.03
2.37
2.17
Linezolid
8.38
1.97
3.86
1.89
2.10
0.60
1.58
0.52
Meropenem
51.09
47.61
44.90
47.51
31.83
20.66
13.02
7.02
Pip/
Tazo
28.88
27.96
27.52
30.11
27.50
30.16
41.96
31.71
Ticar
/
Clav
15.24
12.73
14.90
3.50
0.83
0.20
2.84
2.06
Vancomycin
141.48
140.48
133.47
101.14
96.73
76.28
88.72
70.51
Hospital Census
86,001
83,662
87,053
80,474
79,455
81,105
79,654
83,452 Slide39
ACH NICU Antibiotic Usage
Broad Spectrum includes:
Vanc
,
Dapto
, Linezolid,
Mero
,
Cefepime, Pip/tazo, Ticar/clav, Levo, CiproSlide40
De-escalation
Once culture results are finalized, unnecessary antibiotics are discontinued and or narrowed to a smaller spectrum so as to minimize selective pressure.Slide41
Impact of Incorrect Antibiotic Allergy
Penicillin is the most common allergy, reported in 5-10% of all
patients
Only 2-
15% of patients with reported penicillin allergies actually have a positive reaction to penicillin skin
testing
Non-immunologically mediated adverse drug reactions make up more than 80% of all adverse drug reactions
The rate of positive skin testing in patients with reported penicillin allergy have been decreasing over the past 20 years
Trubiano J, Phillips E. Curr Opin Infect Dis 2013.
Rimawi RH, Cook PP, Gooch M, et al. J Hosp Med 2013.
Macy E, Schatz M, Lin C, Poon K-Y. Perm J 2009.
Macy E, Ngor E. J Allergy Clin Immunol Practice 2013.
Charneski
L, Deshpande G, Smith SW.
Pharmacotherapy
2011.
Unger NR, Gauthier TP, Cheung LW. Pharmacotherapy 2013.
Lee CE, Zembower TR, Fotis MA, et al. Arch Intern Med 2000
.Slide42
Implications of Antibiotic Allergies
When treated for infections, patients with reported penicillin allergies often receive broader
spectrum (fluoroquinolone, 3
rd
/4
th
-generation cephalosporin, clindamycin, aminoglycloside),
suboptimal, and even more toxic agents than patients without reported penicillin
allergies.Reported penicillin allergy has been associated with increased antibiotic resistance, cost, length of hospital stay, and mortality
Lee CE, Zembower TR, Fotis MA, et al. Ann Intern Med 2000.
Unger
NR, Gauthier TP, Cheung
LW.
Pharmacotherapy
2013
.Slide43
Consequences of avoiding β-lactams in patients with β
-lactam allergies
Meghan
Jeffres
,
Prasanna
Narayanan, Jerrica Shuster et al.
J Allergy
Clin Immunol 2016;137:1148-53.Slide44
Cross-sensitivity
Adapted from:
Trubiano
J, Phillips E.
Curr
Opin
Infect Dis 2013; 26: 526-537.Slide45
Antimicrobial Combinations:
Synergy: Gram Positive (MRSA)
Vancomycin plus
Gentamicin
Rifampin
Treatment: Gram Negative (Pseudomonas)
Utilization of 2 gram negative antibiotics that work by different MOA
3 main MOA
Cell wall break down (beta lactams)Inhibition of protein synthesis (Aminoglycosides)Inhibition of DNA gyrase (fluoroquinolones)To Prevent the Emergence of Resistance
Liu C et al. Clin Infect Dis 2011;52:1-38.
Kanj SS et al. Mayo Clin Proc 2011;86:250-9.Slide46
Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial
Daniella Meeker, Jeffrey Linder, Craig Fox et al.
JAMA 2016;315:562-70.
Despite published clinical guidelines and decades of efforts to change prescribing patterns…antibiotic overuse still persists
.
Interventions that have been tried but with minimal reductions in prescription rates for ARTI’s include education, computerized clinical decision support, and financial incentivesSlide47
Purpose
To apply
behavioral science
to design
3
interventions to reduce the rate of unnecessary antibiotic prescribing for ARTI’s
Interventions
:
Suggested alternativesAccountable justification – “
abx
justification note”
Peer comparison – email to peersSlide48
Results (no evidence of diagnosis shifting)
Antibiotic Prescribing
Control:
(educational module or observation alone)
Mean
abx
prescribing rates decreased from 24.1% at intervention start to 13.1% at month 18.
Suggested alternatives:
Mean abx prescribing rates decreased from
22.1
% at intervention start to 6
.1
% at month 18
. (P=0.66)
Accountable justification:
Mean
abx
prescribing rates decreased from
23.2%
at intervention start to
5.2%
at month 18
. (P <.001
Peer Comparison:
Mean
abx
prescribing rates decreased from
19.9%
at intervention start to
3.7%
at month 18
. (P <.001)Slide49
Results
Safety
The rate of return visits for possible bacterial infections within 30 days following visit for ARTI where
abxs
were NOT prescribed (both
abx
inappropriate and potentially appropriate) among the control group was
0.43%.
Only one intervention group had a statistically significantly higher rate of return visits and that was in the accountable justification plus peer comparison group
was
1.41%
.
33 Cases were reviewed
12-
abx
unlikely to have been helpful if prescribed at index visit (cold symptoms with clear chest and no fever at return visit
8- uncertainty (
pt
returned with diagnosis of pneumonia, but no chest radiograph was obtained at the index or return visit
13-
abxs
might have been helpfulSlide50
5 D’s of Antimicrobial Stewardship
Location
MIC
Age/renal function
Weight (obesity)
Other Disease states
Drug Interactions
Fluids
PressorsSlide51
Meaning of a Number: MICSlide52
5 D’s of Antimicrobial Stewardship
Positive cx
vs
negative
What research is current LOT based on?Slide53
Decreasing Duration of Antibiotic Prescribing for Uncomplicated Skin and Soft Tissue Infections
Christine Schuler, Joshua Courter, Shannon
Conneely
et al.
Pediatrics 2016;137(2):e20151223
SSTI’s accounts for the 8
th
most common cause of hospitalization at children’s hospitals.
Increasing incidence due to MRSAIDSA guidelines for management of SSTIs suggest 5 days of abx therapy is effective in cases of nonpurulent cellulitisSlide54
Purpose/Methods
To decrease duration of
abxs
prescribed in children hospitalized for
uSSTIs
Cincinnati Children’s Hospital Medical Center
Fiscal year 2013
4 Interventions
Physician awareness of IDSA guidelines2- 15 min didactic sessions to resident and attendingAccess to best practicesLanyard cardsModification of Electronic Order SetsDefault moved from 14 days to 7 dayID and review of abx plans before dischargeSlide55
Results
641 admissions (90% hospital medicine, 10% community pediatrics)
Increase from 23% to 74% of patients discharged with short courses
Most common
abx
Clinda
- 88%
TMP/SMX- 8%
Cephalexin- 4%Readmissions (no sig differences from prior to study)26 (4%) were readmitted11 for recurrence16 for treatment failureSlide56
Short vs Prolonged Courses of Antibiotic Therapy for Children with Uncomplicated Gram-negative bacteraemia
Park SH et al. J
Antimicrob
Chemother
2014;69:779-85.
Objectives:
Compare clinical outcomes of patients with uncomplicated GN bacteremia receiving short (7-10 days) versus prolonged (>10 days) duration of antibiotic therapy.
Method: Retrospective cohort study between 2002 and 2012. Estimated bacteremic relapse among children who received short vs prolonged antibiotic therapy.Slide57
Results170 matched pairsDuration of therapy in short and prolonged were 10 days and 14 days, respectively
30 day mortality was similar
Prolonged therapy did not reduce the relapse risk
Possible association with an increased risk found for
candidemia
in prolonged treatment.Slide58
5 D’s of Antimicrobial Stewardship
IV to PO
GAP in current stewardship research/intervention between hospital and community for PO Rx’s.
Ensuring consistency with what was prescribed inpatient.Slide59
SummaryASP standard goes into effect per the Joint Commission in January….Are you ready?
Leaders must be identified...are you the one?
If you are the one....empower those around you to help with the cause...this is a huge undertaking.
If you are not the one....there are many things you can do to help.
This is a TEAM effort...all healthcare providers are needed....and pharmacy can take the initiative...we have the drug expertise!!!Slide60
What prevents the intravenous to oral antibiotic switch? A qualitative study of hospital doctor’s accounts of what influences their clinical practice.
Broom J et al. J
Antimicrob
Chemother
2016;71:2295-99.Slide61
QuestionWhich of the following is the narrowest spectrum antibiotic?
Linezolid
Levofloxacin
Cefepime
NafcillinSlide62
Questions