9/22/2016

Antimicrobial Stewardship: Important State and National Updates Jessica Holt, PharmD, BCPS-AQ ID Infectious Diseases Clinical Pharmacy Coordinator Abbott Northwestern Hospital Minneapolis, MN 1

Disclosures and Acknowledgement

• Acknowledgement – Krista Gens, PharmD, BCPS-AQ ID

• Disclosures – Jessica Holt: Nothing to Disclose – Krista Gens: Nothing to Disclose

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Pharmacist Objectives

• Outline proposed Centers of Medicare and Medicaid Services (CMS) requirements surrounding antimicrobial stewardship • Differentiate the requirements surrounding antibiotic use and antimicrobial resistance reporting to the CDC’s National Healthcare Safety Network (NHSN) • Formulate potential antimicrobial stewardship initiatives that can be achieved at your site

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Background

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Background

CID January 2007

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CMS Draft Surveyor Worksheet: October 14, 2011 • Identifies and tracks patients in the hospital with MDROs • Evidence that the hospital has developed and implemented policies

and procedures aimed at preventing MDROs • Multidisciplinary process for reviewing antimicrobial utilization, susceptibility patterns, and antimicrobial agents with evidence that the process is followed • Systems in place to prompt appropriate use • Antibiotic orders include an indication for use • Mechanisms in place to prompt a review of therapy (“Time-Out”) • Mechanisms for IV to PO conversion MDROs: multidrug resistant organisms https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf 6

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http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf 7

Executive Order – Combating Antibiotic Resistant Bacteria, September 2014

• “I hereby order to form a government task force and presidential advisory council on the growing problem of bacteria becoming resistant to antibiotics. The order calls for new regulations on antibiotic stewardship in hospitals, better surveillance on the spread of resistant bacteria, and development of novel treatments for bacterial infections.” – President Barack Obama

http://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria 8

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Executive Order – Combating Antibiotic Resistant Bacteria, September 2014

• By end of 2016, HHS, DoD, and VA shall propose new regulations/actions that require inpatient facilities to implement robust ASPs and take steps to encourage other healthcare facilities to adopt ASPs. • Task Force agencies should monitor antibiotic use through the National Healthcare Safety Network and other systems.

HHS: Department of Health and Human Services, DoD: Department of Defense; VA: Department of Veterans Affairs http://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria 9

National Strategy for Combating AntibioticResistant Bacteria – Goals • Slow the development of and prevent the spread of resistant infections • Strengthen national one-health surveillance efforts • Advance development and use of rapid and innovative diagnostic tests • Accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines • Improve international collaboration and capacities for prevention, surveillance, control, and antibiotic research and development

http://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf 10

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Proposed CMS rule on Antibiotic Use Reporting

• Proposed rule released for comment on April 27th, 2016. – Comment period ended on June 17th, 2016.

Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 11

IDSA/SHEA Updated Guidelines, CID May 2016

• Includes recommendations on: – Specific interventions – Antibiotic optimization – Microbiology/laboratory diagnostics – Measurement 12

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• Comment period ended June 17, 2016

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https://www.jointcommission.org/prepublication_standards_antimicrobial_ stewardship_standard/

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Joint Commission and CMS Requirements 15

Comparing Regulations The Joint Commission • Leaders establish antimicrobial stewardship as an organizational priority

CMS (Proposed) • “…each [hospital] has facilitywide…antibiotic stewardship programs. The programs would be coordinated with …the QAPI program…for the optimization of antibiotic use through stewardship.”

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Examples of Ways to Meet Standard • Develop formal antibiotic

stewardship committee that reports to hospital’s quality committee • Budget plans dedicating resources to stewardship (e.g., IC, Lab, Pharmacy) • Included in performance improvement/strategic plan • Dedicated IT resources to collect data from EMR 17

Comparing Regulations The Joint Commission • “…educates staff and licensed independent practitioners involved in antimicrobial ordering, dispensing, administration, and monitoring about antimicrobial resistance and antimicrobial stewardship… Education occurs upon hire or granting of initial privileges and periodically thereafter…”

CMS (Proposed) • “…competency-based training and education…of personnel and staff, including medical staff, and, as applicable, personnel providing contracted services…on the practical applications of antibiotic stewardship guidelines, policies, and procedures.”

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Examples of Ways to Meet Standard

• Include in mandatory education and/or training • Integrate into existing education (e.g., newsletters, intranet, grand rounds) • Targeted in-person education (e.g., staff meetings, conferences)

http://www.nebraskamed.com/careers/education-programs/asp

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Comparing Regulations The Joint Commission • “The hospital educates patients,

CMS (Proposed) • Not addressed

and their families as needed, regarding the appropriate use of antimicrobial medications, including antibiotics.”

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Examples of Ways to Meet Standard

• Same standard around education as NPSG • Incorporate into patient education around infection prevention and control • Keep it simple http://www.cdc.gov/getsmart/community/materialsreferences/index.html

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Comparing Regulations The Joint Commission • “…has an antimicrobial stewardship multidisciplinary team that includes the following members, when available in the setting: – ID physician – Infection preventionist(s) – Pharmacist(s) – Practitioner”

CMS (Proposed) • “…flexibility in how antibiotic stewardship programs are implemented.” • “…require the hospital…to designate an individual, who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship, as the leader of the antibiotic stewardship program.”

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Examples of Ways to Meet Standard

• Develop antibiotic stewardship committee • Part-time, consult, or telehealth staff acceptable • Antimicrobial stewardship certificate training – SIDP: pharmacists only – MAD-ID: all healthcare providers; basic and advanced programs

http://www.sidp.org/Stewardship-Certificate

http://mad-id.org/antimicrobial-stewardship-programs/

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Comparing Regulations The Joint Commission • “…antimicrobial stewardship program includes the following core elements: – Leadership commitment – Accountability – Drug Expertise – Action – Tracking – Reporting – Education”

CMS (Proposed) • “Guidance on best practices…is available from several organizations including IDSA, SHEA, [ASHP], and CDC.”

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CDC Core Elements • • • • • • •

Leadership Commitment: Resource dedication Accountability: Single leader responsible for outcomes Drug Expertise: Single pharmacist to improve antibiotic usage Action: Implementing at least one recommended action Tracking: Prescribing, usage, and resistance patterns Reporting: Regularly to all relevant staff Education: Resistance and optimal prescribing

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CDC Core Elements - Checklist

http://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf 26

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NQP Antibiotic Stewardship Playbook http://www.qualityforum.org/Publications/2016/05/Antibiotic_Stewardship_Playbook.aspx

• Developed by public- and private-sector leaders and experts • • • • •

representing over 40 organizations, including ASHP and SIDP Includes specific examples to meet each of the CDC Core Elements Designed to strengthen current programs as well as create new programs Includes potential barriers for each Core Element and suggested solutions Describes measurement approaches, including utilization of the NHSN Antimicrobial Use and Resistance Modules Includes appendix with URL links to resources

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NQP Antibiotic Stewardship Playbook http://www.qualityforum.org/Publications/2016/05/Antibiotic_Stewardship_Playbook.aspx

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Comparing Regulations The Joint Commission • “…antimicrobial stewardship program uses organizationapproved multidisciplinary protocols”

CMS (Proposed) • “The provisions would require…that the antibiotic stewardship program adheres to the nationally recognized guidelines, as well as best practices, for improving antibiotic use.”

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Examples of Ways to Meet Standard

• Antibiotic use guidelines • IV to PO policy • Renal dosing policy • Formulary restrictions • Preauthorization requirements • Use of prophylactic antibiotics

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Comparing Regulations The Joint Commission • “The hospital collects, analyzes, and reports data on its antimicrobial stewardship program”

CMS (Proposed) • “Demonstrate coordination…for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, and nursing and pharmacy services” • “Document the evidence-based use of antibiotics in all departments and services”

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Examples of Ways to Meet Standard

• Evaluations of the antibiotic stewardship program • Antimicrobial prescribing patterns • Antimicrobial resistance patterns • Report data to medical staff committee (e.g., P&T, infection prevention and control, QAPI)

Recommendation Dose Adjustment Route Change Add a New Medication Change/Modify Medication Consult Specialist Discontinue/Duration Indication Lab or non-lab orders Order/Note Clarification* Total 1Q2016 Total 2015

Number Accepted 18 25 25 121 13

Total # Recommendations 18 25 28 150 15

% Accepted 100% 100% 89% 81% 87%

292 0 23

338 1 34

86% 0% 68%

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100%

537 1089

629 1303

85% 84%

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Comparing Regulations The Joint Commission • “The hospital takes action on improvement opportunities identified in its antimicrobial stewardship program”

CMS (Proposed) • “Demonstrate improvements, including sustained improvements, in proper antibiotic use, such as through reductions in CDI and antibiotic resistance”

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Examples of Ways to Meet Standard

• Quality improvement projects (e.g., medication use evaluations) • Residency projects (e.g., implementation of a new treatment protocol or guideline) • Order set development

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Antibiotic Use and Resistance Reporting

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Proposed CMS rule on Antibiotic Use Reporting

• Purpose: “The NSHN AUR Module provides a mechanism for facilities to report and analyze antimicrobial use/or resistance as part of local or regional efforts to reduce antimicrobial resistant infections through antimicrobial stewardship efforts or interruption of transmission of resistant pathogens at their facility.” • Monthly reporting of both antibiotic use (days of therapy) and resistance data Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 36

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National Healthcare Safety Network (NHSN)

• Infections are identified through a combination of data mining

(readmission reports, lab reports, etc) and manual case review by Infection Preventionists. • National benchmark rates • Quarterly reporting • Currently: – CAUTI – CLABSI – Surgical Infections (colo and hyst) – CDI 37

Antimicrobial Use and Resistance (AUR) Module

• Antimicrobial Days (Days of Therapy): sum of days for which any amount was given – As documented as administered in the eMAR • Pharmacy orders, doses dispensed, doses billed NOT accepted

– Topical NOT included

Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 38

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Example Calculations

Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 39

Antimicrobial Use and Resistance (AUR) Module

• DOT Divided by – Days Present (patient care location-specific analysis and facility-wide inpatient analysis) – Admissions (facility-wide inpatient analysis ONLY) • Monthly aggregate (sum of all days present) • CANNOT sum days present of patient care location-specific areas – Sum patient care location specific > admissions due to transfers

• Currently used for NHSN MDRO/CDI Module

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Standardized Antimicrobial Administration Ratio

Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 41

16 SAARs

• Different combinations of groupings for: – Broad-spectrum for hospital-acquired infections – Broad-spectrum for community-acquired infections – Anti-MRSA agents – SSI prophylaxis agents

• In the locations of:

– Adult medical, surgical, and med/surg non-ICU – Adult medical, surgical, and med/surg ICUs – Pediatric medical, surgical, and med/surg non-ICU – Pediatric medical, surgical, and med/surg ICUs Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 42

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What does a SAAR mean?

• If SAAR = 1  use is as expected • If SAAR 1  use is more than expected

Proposed CMS rules. https://federalregister.gov/a/2016-09120 Accessed July 13, 2016. 43

SAAR Considerations

• CMS’s existing data set is “nationally aggregated” but rather limited • > 1 or