Fight antibiotic resistance! Join us and participate in Get Smart About Antibiotics Week 2016. Medical epidemiologist Dr. Kavita Trivedi will share her deep wealth of knowledge to help your organization implement and meet the challenges of antimicrobial stewardship. - Current regulatory environment - Implementation tools available - Implementation challenges

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Advisor Live: Nov. 15, 2016
Our Presentation:
Advancing Antimicrobial Stewardship
with Dr. Kavita Trivedi
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Faculty
Kavita Trivedi, MD
Medical epidemiologist
Jessi Stout, Pharm.D
Clinical product manager

4. Advancing Antimicrobial
Stewardship
Premier
November 15, 2016
Kavita K. Trivedi, MD
Principal, Trivedi Consults, LLC
Adjunct Clinical Professor of Medicine, Stanford University
School of Medicine

5. Objectives
• Describe the current regulatory
environment
• Define various implementation tools that
are available or forthcoming
• Discuss antimicrobial stewardship
implementation challenges
5

6. Antimicrobial Stewardship
• Stewardship is the responsible overseeing
and protection of something considered
worth caring for and preserving
– Antimicrobials are worth preserving
– Not synonymous with restriction
6

7. Antibiotic Stewardship Program
(ASP) Prevalence in US Hospitals
• Not new concept –
– Sir Alexander Fleming addressed in 1945
Noble Prize acceptance speech
7

8. 88
© SHEA, 2011
Sir Alexander Fleming
“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

9. ASP Prevalence in US
Hospitals
• Not new concept
– Sir Alexander Fleming addressed in 1945
Noble Prize acceptance speech
– Documented ASPs since 1970s in US
hospitals
9
Doron S, Nadkarni L, Lyn Price L, et al. A nationwide survey of antimicrobial stewardship
practices. Clin Ther . 2013; 35:758–65.

10. 10

11. Percentage of Facilities in Each State Meeting all 7 Core Elements, 2015
Percentage Meeting All 7 elements 7 - 33 34 - 45 47 - 54 56 - 77
45%
40%
63%
43%
70% 49%
47%
38%
50%
64%
48%
60%
54%
48% 54%
26%
28%
41%
33%
51%
60%
59%
45%
24%
24%
36%
30%
31%
48%
27%
58%
40%
59%
67%
12%
51%
35%
37%
54%
67%
56%
33%
47%
41%
77%
7 %
60%
48%
47%
47%
33%
24%
Overall: 48%
4569 hospitals responded in 2015 (4184 in 2014)
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

12. ASP Prevalence in US
Hospitals
• Not new concept
– Sir Alexander Fleming addressed in 1945
Noble Prize acceptance speech
– Documented ASPs since 1970s in US
hospitals
• ~50% hospitals have an ASP according to
CDC’s NHSN (meet all 7 core elements)
• What about the rest and standardization?
12
Doron S, Nadkarni L, Lyn Price L, et al. A nationwide survey of antimicrobial stewardship
practices. Clin Ther . 2013; 35:758–65.

13. Slide courtesy of Arjun Srinivasan

14. 2015 NHSN Hospital Survey
Stewardship Take Homes
• More hospitals appear to be reporting
implementation of the “Core Elements”.
– Gains are occurring in all hospital types
• Smaller hospitals still lag larger ones by
quite a bit.
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

15. 15

16. CDC Vital Signs March 4, 2014
• Dr. Tom Frieden: CDC recommends every
hospital adopt an ASP with seven core
elements
• Dr. John Combes (VP of American
Hospital Association):
– In support of CDC recommendation
16

17. CDC Publication
March 2014
Core Elements:
• Leadership
Commitment
• Accountability
• Drug Expertise
• Action
• Tracking
• Reporting
• Education

18. September 18, 2014
• White House announced a national effort
to combat antibiotic resistance in bacteria.
• Three key items released on that day:
– Report from the President’s Council of
Advisors on Science at Technology (PCAST)
– National Strategy for Combatting Antibiotic
Resistant Bacteria
– Executive Order
• Stewardship prominent in all three
18

19. National Strategy
• All states will implement stewardship activities in
healthcare settings
• All federal facilities will have robust stewardship
programs
• 95% of hospitals will report antibiotic use data to
NHSN
• Reduce inappropriate use for monitored
conditions/agents by 20% inpatient and 50%
outpatient
• CDC and AHRQ will expand research
19

20. White House Summit on Antibiotic
Stewardship: June 2015
• >150 organizations present
• Both animal and health sectors; public and
private entities
• Each organization had to submit how they
are committed to addressing CARB
Strategy
20
https://www.whitehouse.gov/the-press-office/2015/06/02/fact-sheet-over-150-
animal-and-health-stakeholders-join-white-house-effo

21. CMS Proposed Regulations for
Certified Nursing Homes, July 2015
Antibiotic stewardship
integrated within pharmacy and
infection prevention and control
(IPC):
•Expanding pharmacy medication
reviews to include antibiotics for
monthly review; reviews also occur
for all new admissions/re-
admissions, (§483.45)
•Antibiotic use protocols and
monitoring included in IPC
(§483.80)
•Integrating IPC and antibiotic
stewardship into QAPI activities
(§483.75)
https://www.federalregister.gov/articles/2015/07/16/2015-17207/medicare-and-
medicaid-programs-reform-of-requirements-for-long-term-care-facilities

22. CMS Rule: Reform of
Requirements for LTCFs
• Rule goes into effect November 28, 2016
• Phased in implementation:
– Phase 1 by November 28, 2016
– Phase 2 by November 28, 2017
– Phase 3 by November 28, 2019
22
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-
23503.pdf?utm_campaign=pi%20subscription%20mailing%20list&utm_source=federalregister.gov&utm_medi
um=email

23. CMS Rule: Pharmacy
Services (§ 483.45)
• “…a pharmacist be required to review the resident’s
medical record coincident with the drug regimen review
when—(1) the resident is new to the facility; (2) a prior
resident returns or is transferred from a hospital or other
facility; and (3) during each monthly drug regimen review
when the resident has been prescribed or is taking a
psychotropic drug, an antibiotic, or any drug the QAA
Committee has requested be included in the
pharmacist’s monthly drug review. We are proposing the
last criteria to give each facility’s QAA Committee the
ability to request that certain drugs receive more scrutiny
during the monthly drug regiment review.”
23
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-
23503.pdf?utm_campaign=pi%20subscription%20mailing%20list&utm_source=federalregister.gov&utm_medi
um=email

24. CMS Rule: Infection Control
(§ 483.80)
• “…the facility’s IPCP must also include an
antibiotic stewardship program that
includes antibiotic use protocols and
systems for monitoring antibiotic use and
recording incidents identified under the
facility’s IPCP and the corrective actions
taken by the facility.”
24
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-
23503.pdf?utm_campaign=pi%20subscription%20mailing%20list&utm_source=federalregister.gov&utm_medi
um=email

25. CMS Proposed Rule: Reform
of Requirements for LTCFs
• § 483.45 – Medical chart review:
Implemented in Phase 2
• § 483.80 – Antibiotic stewardship
implemented in Phase 2
25
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-
23503.pdf?utm_campaign=pi%20subscription%20mailing%20list&utm_source=federalregister.gov&utm_medi
um=email

26. • Revisions include:
• §482.42 - require hospitals to develop and
maintain ASPs
• Require hospital’s IPC and ASP be active and
hospital-wide for surveillance, prevention, and
control of HAIs and for the optimization of
antibiotic use through stewardship
• Program demonstrate adherence to nationally
recognized IPC guidelines as well as best
practices for improving antibiotic use
26
CMS Proposed Hospital ASP as a
Condition of Participation

27. CMS Proposed Revisions to
IC CoP
• “We are proposing to intentionally build flexibility
into the regulation by proposing language that
requires hospitals to demonstrate adherence to
nationally recognized guidelines rather than any
specific guideline or set of guidelines for
infection prevention and control and for 33
antibiotic stewardship. While the CDC guidelines
represent one set, there are other sets of
nationally recognized guidelines from which
hospitals might choose, such as those
established by SHEA and IDSA.”
27

28. Policy Developments- Reporting
Hospital Inpatient Prospective Payment System
2017 Proposed Rule
“In the future, we are considering proposing the
NHSN Antimicrobial Use measure to advance
national efforts to reduce the emergence of
antibiotic resistance by enabling hospitals and
CMS to assess national trends of antibiotic use to
facilitate improved stewardship by comparing
antibiotic use that hospitals report to antibiotic use
that is predicted based on nationally aggregated
data.” - CMSPage 25197
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

29. Antibiotic Use Reporting and CMS
Hospital Reporting Requirements
• Many public comments were submitted.
• Most comments were supportive of the need
for antibiotic use measures and
benchmarking.
• Most comments pointed out that the current
CDC SAAR measure will need to be refined.
• General theme on public reporting and pay
for performance, “Probably helpful, but not
yet”.
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

30. The Joint Commission
Accreditation Standard
• The Joint Commission has issued an
accreditation standard for antibiotic
stewardship programs in hospitals.
– Compliance required starting January 2017.
• Eight performance elements.
• The standard generally reflects the CDC
Core Elements.
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

31. CDC Publication
November 2016
Core Elements:
• Commitment
• Action
• Tracking and
reporting
• Education and
expertise

32. What Now?
• Unprecedented time for antibiotic
stewardship
• National strategy for advancing
stewardship as a key part of combating
resistance
• Now comes the hard part of putting reports
and strategies into action
32

33. California is an Antimicrobial
Stewardship Leader
33

34. California Senate Bill 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) (2006)
http://www.dhcs.ca.gov/provgovpart/initiatives/nqi/Documents/SB739.pdf34

35. California Senate Bill 1311
(Hill)
• Health and Safety Code 1288.85(a-d).
Each California general acute care
hospital, shall have a multidisciplinary,
physician-supervised ASP with educated
champion by July 1, 2015.
• Signed by Governor Brown September 29,
2014
35 http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb_1301-1350/sb_1311_bill_20140929_chaptered.html

36. California Senate Bill 361
• 1275.4. (a) On or before January 1, 2017, each skilled
nursing facility, as defined in subdivision (c) of Section
1250, shall adopt and implement an antimicrobial
stewardship policy that is consistent with antimicrobial
stewardship guidelines developed by the federal
Centers for Disease Control and Prevention, the
federal Centers for Medicare and Medicaid Services,
the Society for Healthcare Epidemiologyof America,
or similar recognized professional organizations.
• Signed October 10, 2015
36 http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160SB361

37. CDC Core Elements of ASPs
in Nursing Homes
• Adaptation of Core Elements for Hospital
ASPs into practical ways to initiate or
expand antibiotic stewardship activities in
nursing homes
• Nursing homes are encouraged to work in
a step-wise fashion, implementing one or
two activities to start and gradually add
new strategies from each element over
time
37 http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html

38. California Senate Bill 27 (Hill)
• 14401. Beginning January 1, 2018, a medically important
antimicrobial drug shall not be administered to livestock
unless ordered by a licensed veterinarian through a
prescription or veterinary feed directive, pursuant to a
veterinarian-client-patient relationship that meets the
requirements of Section 2032.1 of Title 16 of the
California Code of Regulations.
38
https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=201520160
SB27

39. California Senate Bill 27 (Hill)
• 14402. (a) Beginning January 1, 2018, a medically important
antimicrobial drug may be used when, in the professional judgment
of a licensed veterinarian, the medically important antimicrobial drug
is any of the following:
– (1) Necessary to treat a disease or infection.
– (2) Necessary to control the spread of a disease or infection.
– (3) Necessary in relation to surgery or a medical procedure.
• (b) A medically important antimicrobial drug may also be used when,
in the professional judgment of a licensed veterinarian, it is needed
for prophylaxis to address an elevated risk of contraction of a
particular disease or infection.
• (c) A person shall not administer a medically important antimicrobial
drug to livestock solely for purposes of promoting weight gain or
improving feed efficiency.
• (d) Unless the administration is consistent with subdivision (a), a
person shall not administer a medically important antimicrobial drug
in a regular pattern.
39

40. California Senate Bill 27 (Hill)
• Approved by Governor Brown 10/10/2015
40
https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=201520160
SB27

41. California remains only state
with legislation regarding
judicious use of antibiotics
41

42. California remains only state
with legislation regarding
judicious use of antibiotics
42

43. Missouri SB 579
• Requires antibiotic stewardship programs
in hospitals and ASCs by August 28, 2017
• Requires all hospitals to report to CDC’s
NHSN AUR module when stage 3
Meaningful Use requirements are
finalized.
– Antibiotic use and resistance data will be
shared with the health department, but will not
be reported to the public.
• Signed by Governor on June 2016
43
http://www.senate.mo.gov/16info/pdf-bill/perf/SB579.pdf
http://www.house.mo.gov/billtracking/bills161/jrnpdf/jrn056.pdf#page=55

44. Antibiotic Stewardship
Implementation
44

45. Guidelines for the Development
of an Institutional ASP
• Developed by professional societies
(Infectious Diseases Society of America
(IDSA) and Society for Healthcare
Epidemiology of America (SHEA))
• Clinical Infectious Diseases 2007
• Team, elements of an ASP including
strategies and measurement, research
priorities and future directions
45 Dellit TH, Owens RC, McGowan JE, et al. Clin Infect Dis 2007; 44(2):159–77.

46. ASP Implementation
• Menu of interventions/strategies
• Customizable with application in every
healthcare setting including limited
resource settings:
– Lack of funding/personnel
• Eg. some community hospitals
Septimus EJ, Owens RC, Jr. Need and potential of antimicrobial stewardship in community
hospitals. Clin Infect Dis 2011 August;53 Suppl 1:S8-S14.

47. US ASP Infrastructure Varies
• In a national survey, of 406 US healthcare
providers, 206 (51%) respondents
reported working in a hospital with an ASP
– Of these, 71% included ID physicians, 59% ID
pharmacists, and 51% IPs
– Hospitals with an ASP were 3x more likely to
have an ID consultation service or an ID
pharmacist than hospitals without an ASP
47
Doron S, Nadkarni L, Lyn Price L, et al. A nationwide survey of antimicrobial stewardship
practices. Clin Ther . 2013; 35:758–65.

48. ASP Core Competencies
• Published November 25, 2014 in Infection
Control Hospital Epidemiology jointly by
SHEA, IDSA, SIDP, MAD-ID, NFID, PIDS
– Stakeholders including physician, pharmacist,
IP, microbiologist, hospital administration
48
Guidance for the Knowledge and Skills Required for Antimicrobial Stewardship Leaders. SE
Cosgrove, ED Hermsen, MJ Ryback et al. Infect Control Hosp Epidemiol. Vol. 35, No. 12
(December 2014), pp. 1444-1451.

49. SHEA/IDSA: ASP
Implementation Guidelines
•Revised guidelines take a practical approach by
offering pragmatic advice and endorsing programs
tailored to each institution’s unique situation
•Focus on individual interventions
•Expert panel weighed strength of each
recommendation and the quality of evidence
behind it.
•28 recommendations are offered
49
Barlam TF, SE Cosgrove, LM Abbo et al. Implementing an Antibiotic Stewardship Program:
Guidelines by the Infectious Diseases Society of America and the Society for Healthcare
Epidemiology of America. Clin Infect Dis. 2016 Apr 13.

50. SHEA/IDSA: ASP
Implementation Guidelines
26. In nursing homes and skilled nursing facilities, we
suggest implementation of antimicrobial stewardship
strategies to decrease unnecessary use of antimicrobials
and improve clinical outcomes [Good practice
recommendation]
– Comment: Implementing ASPs at nursing homes and SNFs is
important and must involve point-of-care providers to be
successful. The traditional physician-pharmacist team may not
be available on-site and facilities might need to investigate other
approaches to review and optimize antibiotic use, such as
obtaining infectious diseases expertise through telemedicine
consultation.
50
Barlam TF, SE Cosgrove, LM Abbo et al. Implementing an Antibiotic Stewardship Program:
Guidelines by the Infectious Diseases Society of America and the Society for Healthcare
Epidemiology of America. Clin Infect Dis. 2016 Apr 13.

51. • 1st attempt to estimate national hospital
antibiotic use over time.
• Extrapolated from proprietary data
(MarketScan Hospital Drug Database).
• Weighted estimate created to produce
national use in DOT/1000 patient days.
JAMA IM published on-line 9/19/16
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

52. National Estimate of US
Hospital Antibiotic Use
• Overall use was 755 DOT/1000 patient days
– No change from 2006-12
• Use of some classes went down:
– Quinolones (20%), 1st generation cephalosporins
(7%)
• Use of many classes went up:
– Vancomycin (32%), beta-lactam/inhibitor (26%),
3rd/4th generation cephalosporins (12%)
• Biggest increase in carbapenem use: 37%.
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

53. US Hospital Antibiotic Use
• Use varied between ICU and non-ICU
locations
– 1092 DOT/1000 PD vs 720 DOT/1000 PD
• Use varied by geography: New-England,
Mid-Atlanta, Pacific lowest
• Non-teaching hospitals had higher use
than teaching.
– Large urban teaching hospitals did not have
higher use than other hospitals.
• Use did not vary by bed size (more or less
than 300) or by urban vs. rural location
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

54. Standardized Antibiotic
Administration Ratio (SAAR)
• SAAR measure has been developed with many
experts to try and make it most useful.
• SAAR expresses observed to expected antibiotic
use where expected use is calculated based on
facility level risk adjustment.
• SAARs for different groups of antibiotics:
• Agents mainly for healthcare associated pathogens
• Agents mainly for community pathogens
• Agents active against MRSA
• Agents frequently use for surgical prophylaxis
• All agents
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

55. Update on the SAAR
• Standardized Antimicrobial Administration
Ratio was endorsed by National Quality
Forum in January 2016.
• SAAR benchmark values are now
available to all hospitals enrolled in the
NHSN Antibiotic Use option.
• Working with users to continually improve
display and use of antibiotic use data.
• Starting to look at SAAR data nationally.
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

56. SAAR Assessment Tool
• CDC partnered with Pew and an expert
panel to review the literature and
experience to try and help hospitals
identify potentially high-yield opportunities
to improve use.
• Tool could be used to assess use in
locations with high SAARs and look for
opportunities for improvement in any
location
• On CDC website soon
Arjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop

57. CDC and the National Quality
Partnership of the National
Quality Forum
• Developed an Antibiotic Stewardship
Playbook
– Represents input from >30 stakeholders
– Based on the CDC Core Elements for
Hospital Antibiotic Stewardship Programs
– Has specific suggestions for implementation
and a special section on measurement
57

58. CDC/NQF Antibiotic Stewardship
Playbook: Leadership
Commitment
• Examples of implementation:
– Issue formal board-approved statement on the
importance of the ASP and include in annual report
• Potential barriers and solutions:
– Poor support of ASP by leaders - refer to key national
reports on importance of antibiotic stewardship and
direct leaders to proposed regulatory requirements.
• Tools and Resources:
– Making the Business Case for ASP: Taking It to the
C-Suite
58 www.qualityforum.org/NQP/Antibiotic_Stewardship_Playbook.aspx

59. Conclusions
59

60. Antibiotic Stewardship
• Recognized as a priority in US healthcare
facilities
– Will be required for CMS reimbursement
• Antibiotic Use and Resistance measures
will be required and reported via CDC’s
NHSN
• Every healthcare provider can act as an
antibiotic steward
• There are opportunities to reduce
antimicrobial use in every US institution
60

61. Go Forth as Antibiotic
Stewards
• Stewardship is the responsible overseeing
and protection of something considered
worth caring for and preserving
– Antibiotics are worth protecting, especially for
future generations
– If we did not have antibiotics, modern
medicine would not be possible:
• Burn treatment, chemotherapy, transplantation
61

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Actions to take for success
• Evaluate existing data to
determine a starting
point
• Identify metrics with
impact to report
• Consider participation in
NHSN’s AU/AR module
• Provide feedback
• Make improvements
• Garner leadership
commitment
• Identify a clinical
champion with
influence
• Engage clinicians
• Perform a gap analysis
of the current
stewardship program
• Evaluate which
guideline to implement
Assess Engage
MeasureReevaluate

63. PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.
63 PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.
Premier is aligned with industry standards
The National Action
Plan for Combating
Antimicrobial
ResistantBacteria
CMS’ proposed
new regulatory
standard:
Antibiotic
Stewardship
Program Organization
and Policies
National Quality
Forum Playbook for
Antimicrobial
Stewardship
The Joint
Commission’s
new Antimicrobial
Stewardship
Standard
CDC 7 Core
Elements of an
Antimicrobial
Stewardship
Program

64. PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.
64 PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.
Premier is aligned with industry standards
LEADERSHIP COMMITMENT
Formal and Financial Support
Reports and analysis
eSurveillance
Surveillance
Reports and analysis
Surveillance
Reports and analysis
Pharmacy Assistant
Alerts and Surveillance Lists
Medication UtilizationAnalysis
Antibiogram Analysis
Intervention Assistant
Medication UtilizationAnalysis
Antibiogram Analysis
Intervention Assistant
NHSN AU Submission
NHSN AR Submission
ACCOUNTABILITY
Stewardship Program Leader
DRUG EXPERTISE
Pharmacy Leader
ACTION
Stewardship Activities
TRACKING
Resistance and Medication Use
REPORTING
Internal and External
ANTIMICROBIAL
STEWARDSHIP
PROGRAM:
Core Elements
PREMIER
Approach
* Education component not addressed through TheraDoc

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65 PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.
Want to learn more?
Premier Resources:
Premier Safety Institute: Antimicrobial Stewardship
Information, links to references and resources
TheraDoc
Information on Premier’s Clinical Surveillance
Quest 2020
Infection Control & Antimicrobial Stewardship Specialty Network
Information on Premier’s improvement collaborative
Questions? Get in Touch:
Kavita K. Trivedi, MD
Principal, Trivedi Consults, LLC
kavita@trivediconsults.com