Dr. Charles Onunkwo, Infectious Disease Medicine Erika Ingram, Infectious Disease/Critical Care Clinical Pharmacy Specialist Southeastern Regional

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Dr. Charles Onunkwo, Infectious Disease Medicine Erika Ingram, Infectious Disease/Critical Care Clinical Pharmacy Specialist Southeastern Regional Medical Center Cancer Treatment Centers of America May 25, 2017

Disclosures We have no conflicts of interest to disclose and no financial relationships relevant to this activity.

Learning Objectives Review national initiatives that directly influence the role of Antimicrobial Stewardship Programs Highlight common challenges observed in antimicrobial stewardship Identify quantifiable metrics and performance measures for ASP

Antimicrobial Stewardship Icebreakers Superbugs these are our babies now they have body piercings and anger! Antibiotics kill bacteria, not your anxiety. Stop the just-in-case indications.

Importance of Antimicrobial Stewardship Increasing incidence of antimicrobial resistance Injudicious antibiotic use / Inappropriate antibiotic selection Treatment failures and poor patient outcomes Prolonged hospitalization Increasing medical expenditures (use of additional medication, extra laboratory testing) Stabilization of antibiotic resistance Multifactorial approach Antibiotic formulary restrictions Prospective audit and feedback Surveillance of antibiotic utilization and resistance patterns Daily interventions tailored to optimize appropriate antibiotic use

Mirror, Mirror on the Wall..Who is the Best Supporter of Them All?

Infectious Diseases Society of America Centers for Disease Control The Joint Commission (6/2016)

September 2014 President s Executive Order and National Strategy PCAST Report to the President March 2015 National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) PCAST-President s Council of Advisors on Science and Technology

Proposed Policy Changes Strengthen antibiotic stewardship in inpatient, outpatient, and long-term care settings Alignment with Centers for Disease Control (CDC) Core Elements and IDSA/SHEA Compliance with Conditions of Participation and The Joint Commission (TJC) Accreditation requirements Implement annual reporting of antibiotic use in inpatient and outpatient settings and identify variations at geographic, provider, and patient levels

Proposed Policy Changes Establish and improve antibiotic stewardship programs across ALL healthcare settings Reduce inappropriate antibiotic use by 50% in outpatient settings and 20% in inpatient settings Establish State Antibiotic Resistance (AR) Prevention (Protect) Programs in all 50 states

Goals of Antimicrobial Stewardship Improve patient outcomes Optimize selection, dose and duration of Rx Reduce adverse drug events including secondary infection (e.g., Clostridium difficile infection) Reduce morbidity and mortality Limit emergence of antimicrobial resistance Reduce length of stay Reduce health care expenditures

Challenges in ASP The work to achieve success in Antimicrobial Stewardship closely parallels the storybook of.. The Little Engine That Could... When it comes to Infectious Diseases and Antibiotics, there is only do or do not, there is no try.

ASP Misconceptions Lack of Collaboration Where is the Stamp & Seal from Leadership? Challenges Minimal Support / Buy-in Stakeholder Cooperation Problem Prescribers & Behaviors

Are there any familiar hurdles? Stakeholder Cooperation Collaboration Internists/Hospitalists Intensivists General, advanced practitioners Microbiology Pharmacy Physicians Infection Prevention

Common Misconceptions If an Infectious Diseases consultant approves or uses an antibiotic, it must be appropriate Retrospective data collection and analysis can result in change in behavior The adoption of information technology (IT) will automatically make data collection, analysis and change in behavior easy Restricting use of certain antibiotics will reduce antibiotic misuse and overuse

Challenges: Fact or Fiction Not all literature in Infectious Diseases is black & white Everyone is an Expert on the use of antibiotics Providers perceive their autonomy is compromised Concerns for litigation Obtaining buy-in for support of ASP Financial pressures that influence decision-making processes Pharmaceutical Industry Hospitals (Budget) Payer sources Insurance industries Centers for Medicare & Medicaid Services [CMS]) Patients/Support network

Physician Barriers Antibiotics are among the most potent of all anxiolytics for prescribers. Physician accountability & acknowledgement of need for improvement Misperceptions Knowledge gaps in the appropriate use of antimicrobial agents Lack of standardized, risk-adjusted measures Adaptive/behavioral changes needed to modify prescribing practices

Pearls of Wisdom for the Problem Prescriber Map-Out Your Approach Timing of discussion & recommendations is prudent Be strategic and pick your battles Do Your Homework Do Not Go Postal!! Research & gather as much valid data as possible Understand the provider s practice & patient population Do not initiate or engage in heat-of-the-moment battles Accept a stewardshipappropriate compromise

Modifying Prescribing Behaviors Involvement of senior physician leadership is critical Administrative & Clinical Continue to share your stewardship message and education points with non-id providers/clinicians ID should not be excluded from stewardship process Understand local culture and patient population

Fever is not a sign of Vosyn deficiency. Are there any solutions?

IDSA/SHEA, CDC, TJC Guidelines A multidisciplinary ASP team infrastructure ID physician and Pharmacist and other key stakeholders as determined by the institution Incorporate Core Strategies Prospective audit with intervention and feedback Formulary restriction and preauthorization Additional approaches to stewardship Education Guidelines and clinical pathways Order forms De-escalation Dose optimization IV to PO conversion

Antibiotic De-escalation Advantages Allows initial use of broadspectrum therapy Narrows spectrum while maintaining efficacy May influence future prescribing behavior Decreases inappropriate antibiotic use Reduces adverse events Cost savings Disadvantages Prescribers may be reluctant to change therapy if the patient is doing well If not done correctly, may narrow therapy inappropriately

De-escalation Myths Common myths that negatively impact appropriate de-escalation: Lack of conclusive microbiology results Continued use of broad-spectrum antimicrobial therapy Diagnostic uncertainty Treatment of fever, colonization and/or contamination Insecurity Treatment of noninfectious syndrome associated with fever Duration of therapy exceeds evidence-based recommendations

SERMC-CTCA Antimicrobial Stewardship Program Antimicrobial stewardship is a team game with the patient at the center, and it s our teamwork that makes the dream work. Source: 2017 Rising Tide 24

Source: 2017 Rising Tide

2017 Rising Tide

CTCA Enterprise Antimicrobial Stewardship Dashboard + The Joint Commission Standards Source: 2017 Rising Tide 27

Methods to Control Antimicrobial Use Methods to control antimicrobial use Restrictive use (formulary control) Prospective audit and feedback Dellit TH et al. Clin Infect Dis. 2007; 44:159-77. 2017 Rising Tide

SERMC - Formulary Restriction and Preauthorization Ceftaroline Ceftazidime-avibactam Ceftolozane-tazobactam Dalbavancin Daptomycin Ertapenem Linezolid Tigecycline Source: 2017 Rising Tide 31

Source: 2017 Rising Tide 32

Source: 2017 Rising Tide 33

SERMC - Formulary Restriction and Preauthorization Source: 2017 Rising Tide 34

Frequency of Use Frequency of Use ERTAPENEM 2015 7 6 Appropriate vs. Inappropriate Utilization by Quarter 1.2 1 Rationale for Inappropriate Utilization by Quarter 5 4 3 2 1 Appropriate Inappropriate 0.8 0.6 0.4 0.2 Empiric therapy (complicated): IAI, abssi, UTI, PNA Treatment of pathogen outside of spectrum Surgical prophylaxis (excluding colorectal) Other -Q3: abssi -Q4: Inappropriate post-op duration 0 3 1 6 2 Q1 Q2 Q3 Q4 Quarter 0 1 11 Q1 Q2 Q3 Q4 Quarter 2017 Rising Tide

Frequency of Use Frequency of Use ERTAPENEM 2016 4.5 3.5 Appropriate vs. Inappropriate Utilization by Quarter 4 2.5 Rationale for Inappropriate Utilization by Quarter 2 3 2.5 1.5 Empiric therapy (complicated): IAI, abssi, UTI, PNA 2 1.5 Appropriate Inappropriate 1 Surgical prophylaxis (excluding colorectal) Other -Q1: Asymptomatic bacteruria 1 0.5 0.5 0 3 4 3 2 1 Q1 Q2 Q3 Q4 Quarter 0 2 1 1 Q1 Q2 Q3 Q4 Quarter 2017 Rising Tide

Cost SURGICAL ANTIBIOTIC PROPHYLAXIS: COST ANALYSIS $120.00 Cefazolin/Metronidazole vs. Ertapenem $100.00 $97.02 $80.00 $60.00 $40.00 1st Dose 2nd Doses 3rd Doses $20.00 $3.82 $5.59 $7.36 $- cefazolin/metronidazole Surgical prophylaxis agent ertapenem 2017 Rising Tide

SERMC Antibiotic Stewardship Initiative CORE ELEMENTS STATUS ACTION PLAN BROAD INTERVENTIONS Chart review of appropriate use 48-hrs post initiation Pre-authorization (by MD/PharmD) for specific abx agents MD/PharmD review of courses of abx therapy (prospective audit with feedback) Yes Yes Yes -Established chart review process for appropriate abx use at ~48-72 hrs postinitiation. All abx reports print daily (Pyxis Reports) for all inpatient areas. Vigilanz (clinical surveillance sytem) for tracking different entities of ASP - Eight abx utilization protocols developed for pre-authorization process for specific abx. <Continuous> - Dr. Charles Onunkwo (SERMC Infectious Disease Physician) will implement process of prospective audit with feedback will be implemented October 2016 (tentative). 2017 Rising Tide

2017 Rising Tide ASP Initiatives: Daily Antimicrobial Report (Inpatient)

Antimicrobial Stewardship: Performance & Quantitative Measures The most expensive antibiotic is the one that does not work.

ASP Framework: Metrics National Quality Forum

ASP Framework: Metrics National Quality Forum

4.5 SERMC-CTCA Number of HO-CDAD Cases July 2014 - Feb 2017 4 3.5 3 2.5 2 1.5 1 0.5 0 2017 Rising Tide

2016 October Prospective Audit with Feedback ASP Reviews Total Surgical Prophylaxis Discontinue antibiotics Establish Duration of Therapy Modify Abx & Discharge Counseling Add abx therapy & Lab analysis Dose optimize / Dose adj. / New ID consult Source: 2017 Rising Tide 45

2016 November Prospective Audit with Feedback ASP Reviews Surgical Prophylaxis Discontinue antibiotics Establish Duration of Therapy Discharge Counseling IV to PO Modification Modify abx / New ID consult / Lab analysis De-escalate abx / Add abx coverage Dose optimization / BBI regimen Source: 2017 Rising Tide 46

Antimicrobial Stewardship Potential Cost Savings 6,000.00 5,000.00 4,000.00 Modify Abx Regimen per Cx 3,000.00 Establish Therapy Duration 2,000.00 Discontinue Abx 1,000.00 **Cost analysis derived from Vigilanz Clinical Surveillance Tool** Source: 0.00 2016 October 2016 November 2016 December 2017 Rising Tide 47

Conclusion Antimicrobial resistance is a significant public health and patient safety concern Highest levels of government officials are highlighting antimicrobial stewardship and efforts to decrease resistance TJC and CMS are developing guidance for accreditation based on an effective ASP, including publicly reportable measures All stakeholders should be engaged in antimicrobial stewardship and across the continuum of care.

Mirror, mirror on the wall. Do I need antibiotics at all? Thank You! To learn how to use antibiotics, one must first learn how not to use antibiotics. If we use antibiotics when not needed, we may not have them when they are most needed. Asymptomatic Bacteriuria: Symptom free pee: Let it be

References