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WelcomeAdvisor Live: Nov. 15, 2016
Our Presentation:
Advancing Antimicrobial Stewardship
with Dr. Kavita Trivedi
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Faculty
Kavita Trivedi, MDMedical epidemiologist
Jessi Stout, Pharm.DClinical product manager
Advancing Antimicrobial Stewardship
PremierNovember 15, 2016
Kavita K. Trivedi, MDPrincipal, Trivedi Consults, LLC
Adjunct Clinical Professor of Medicine, Stanford University School of Medicine
Objectives• Describe the current regulatory
environment• Define various implementation tools that
are available or forthcoming• Discuss antimicrobial stewardship
implementation challenges
5
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
Antibiotic Stewardship Program (ASP) Prevalence in US Hospitals• Not new concept –
– Sir Alexander Fleming addressed in 1945 Noble Prize acceptance speech
7
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
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
9Doron S, Nadkarni L, Lyn Price L, et al. A nationwide survey of antimicrobial stewardship practices. Clin Ther . 2013; 35:758–65.
10
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
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?
12Doron S, Nadkarni L, Lyn Price L, et al. A nationwide survey of antimicrobial stewardship practices. Clin Ther . 2013; 35:758–65.
Slide courtesy of Arjun Srinivasan
2015 NHSN Hospital SurveyStewardship 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
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
CDC Publication March 2014
Core Elements:• Leadership
Commitment• Accountability• Drug Expertise• Action• Tracking• Reporting• Education
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
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
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
CMS Proposed Regulations for Certified Nursing Homes, July 2015Antibiotic 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
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_medium=email
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_medium=email
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_medium=email
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_medium=email
• 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
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
Policy Developments- Reporting
Hospital Inpatient Prospective Payment System2017 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
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
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
CDC Publication November 2016
Core Elements:• Commitment• Action • Tracking and
reporting• Education and
expertise
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
California is an Antimicrobial Stewardship Leader
33
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
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
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 Epidemiology of America, or similar recognized professional organizations.
• Signed October 10, 2015
36 http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160SB361
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
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.
38https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=201520160SB27
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
California Senate Bill 27 (Hill)• Approved by Governor Brown 10/10/2015
40https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=201520160SB27
California remains only state with legislation regarding
judicious use of antibiotics
41
California remains only state with legislation regarding
judicious use of antibiotics
42
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 201643
http://www.senate.mo.gov/16info/pdf-bill/perf/SB579.pdfhttp://www.house.mo.gov/billtracking/bills161/jrnpdf/jrn056.pdf#page=55
Antibiotic Stewardship Implementation
44
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.
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.
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
47Doron S, Nadkarni L, Lyn Price L, et al. A nationwide survey of antimicrobial stewardship practices. Clin Ther . 2013; 35:758–65.
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.
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.
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.
• 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
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
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 locationArjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop
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
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
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 soonArjun Srinivasan, IDWeek 2016 ASP Pre-Meeting Workshop
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
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
Conclusions
59
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
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
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Premier is aligned with industry standards
The National Action Plan for Combating
Antimicrobial Resistant Bacteria
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
PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.64 PROPRIETARY & CONFIDENTIAL – © 2016 PREMIER, INC.
Premier is aligned with industry standards
LEADERSHIP COMMITMENTFormal and Financial Support
Reports and analysiseSurveillance
SurveillanceReports and analysis
SurveillanceReports and analysis
Pharmacy AssistantAlerts and Surveillance Lists
Medication Utilization AnalysisAntibiogram AnalysisIntervention Assistant
Medication Utilization AnalysisAntibiogram AnalysisIntervention AssistantNHSN AU SubmissionNHSN AR Submission
ACCOUNTABILITYStewardship Program Leader
DRUG EXPERTISEPharmacy Leader
ACTIONStewardship Activities
TRACKINGResistance and Medication Use
REPORTINGInternal and External
ANTIMICROBIAL STEWARDSHIP PROGRAM: Core Elements
PREMIER Approach
* Education component not addressed through TheraDoc
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Want to learn more?
Premier Resources:Premier Safety Institute: Antimicrobial StewardshipInformation, links to references and resourcesTheraDocInformation on Premier’s Clinical SurveillanceQuest 2020Infection Control & Antimicrobial Stewardship Specialty NetworkInformation on Premier’s improvement collaborative
Questions? Get in Touch:Kavita K. Trivedi, MDPrincipal, Trivedi Consults, [email protected]