advisor live: advancing antimicrobial stewardship

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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.

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?


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

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


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


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


• 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


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”.


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.


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


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


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


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.


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


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


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


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


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]