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Critical Antimicrobial Stewardship Program Components for Success Julie Ann Justo, PharmD, MS, BCPS, AAHIVP Assistant Professor, South Carolina College.

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Presentation on theme: "Critical Antimicrobial Stewardship Program Components for Success Julie Ann Justo, PharmD, MS, BCPS, AAHIVP Assistant Professor, South Carolina College."— Presentation transcript:

1 Critical Antimicrobial Stewardship Program Components for Success Julie Ann Justo, PharmD, MS, BCPS, AAHIVP Assistant Professor, South Carolina College of Pharmacy ID Clinical Specialist, Palmetto Health Richland October 24, nd Annual APIC Palmetto Educational Conference

2 Disclosure Prior: Cubist Pharmaceuticals Grant/Research Support for antimicrobial stewardship

3 Objectives List the essential goals and team members of an antimicrobial stewardship program (ASP) Describe the key components to consider during the development of an ASP initiative in the hospital setting Provide examples of successful ASP initiatives

4 Essential Stewardship Ingredients: Goal & Core Team Members

5 Antimicrobial Stewardship Goal: Optimize clinical outcomes and minimize unintended consequences of antimicrobial use Example of interpretation for local ASP goals: 1.Improvement in quality of patient care 2.Minimize toxicity from antimicrobial therapy 3.Reduce antimicrobial resistance 4.Reduce cost of antimicrobial therapy 1. Dellit TH, et al. Clin Infect Dis 2007; 44:

6 What Antimicrobial Stewardship is Not… 1. Yates RR. Chest 1999; 115: 24S-27S.

7 Antimicrobial Stewardship Core Team 1. Dellit TH, et al. Clin Infect Dis 2007; 44: Antimicrobial Stewardship Core Team Infectious Diseases (ID) Physician* Clinical Microbiologist Information System Specialist ID Clinical Pharmacist* Hospital Epidemiologist Infection Control Professional *A-II recommendation, others are A-III Compile raw isolate & susceptibility data Implement micro-driven initiatives Design & integrate clinical decision support systems Ensure patient- and population-level data interface across systems Share goals such as minimizing antimicrobial resistance Expert in initiative development Liaison for dual initiatives Expert in analyzing population-level data Support research study design & outcomes reporting

8 Antimicrobial Stewardship Other key stakeholders: Hospital Administration Provide infrastructure Ensure adequate authority and compensation for AS core Negotiate defined, measurable outcomes Medical Staff Leadership/Local Providers Early buy-in with ASP development Assist with maintenance Pharmacy and Therapeutics Committee Essential for formulary restriction and guideline initiatives ASPs often reside in quality assurance or patient safety departments 1. Dellit TH, et al. Clin Infect Dis 2007; 44:

9 ASST Core 1 ID Physician, Director 1 Senior Clinical Microbiology Technician 4 ID Clinical Pharmacists (2 faculty, 2 hospital employees) 1 Clinical Informatics Specialist Antimicrobial Stewardship & Support Team (ASST): A Local Hospital Experience Full ASST Committee ASST Core Infection Control/Hospital Epidemiologist (ID physician), Infection Control Manager Microbiology Lab Director Physician representation from Surgery, Hospitalists, Intensivists Pharmacy administration Nursing administration, Nurse Practitioners Pediatric ASP Team (2 ID physicians, 2 ID clinical pharmacists) IT System Analysts Representation from all campuses

10 Infectious Diseases Society of America and Society of Healthcare Epidemiology of America (IDSA/SHEA) guidelines for developing AS programs specifically comment on technology: “Health care information technology in the form of electronic medical records (A-III), computer physician order entry (B-II), and clinical decision support (B-II) can improve antimicrobial decisions through the incorporation of [patient-specific] data...” Antimicrobial Stewardship 1. Dellit TH, et al. Clin Infect Dis 2007; 44:

11 The Stewardship Geek Squad Antimicrobial Stewardship Core Team Information Technology Clinical Informatics informatics.com/files/imagecache/100x100/DoctorNurseLaptop_ _SMALLER.jpg 3.

12 Information System Specialists Pr 1. Bernstam EV, et al. Acad Med 2009; 84: Information Technology (IT) Specialist Primarily concerned with application of technology, i.e. computer science Operational IT: Computers, servers, , electronic medical record Research IT: Clinical data warehouse “Help! Make it go…” Biomedical (Clinical) Informatics Specialist Primarily concerned with storage, retrieval, and optimum use of data, information, and knowledge for problem solving and decision- making View computers as tools for manipulating information Key expertise is to improve connectivity between patient data and knowledge in order to aid in clinical decision-making Computer savvy ≠ IT support!

13 Interdisciplinary Effort Determines the destination Antimicrobial Stewardship Charts the course Clinical Informatics Steers the ship Information Technology

14 I thought you knew how to drive! I thought you knew how to navigate! I didn’t know we were going off-road! IT CI ASP Or…

15 Developing Hospital Antimicrobial Stewardship Initiatives: Key Components

16 What to do?... Problem Identification & Strategy Development Who will do it?... Engaging Clinicians How to do it?... Technology Why do it?... Outcomes Evaluation Key Components for ASP Initiatives

17 What to do?... Problem Identification & Strategy Development Who will do it?... Engaging Clinicians How to do it?... Technology Why do it?... Outcomes Evaluation Key Components for ASP Initiatives

18 Problem Identification Start with the mission statement Example: Local ASST Goals 1.Improvement in quality of patient care 2.Minimize toxicity from antimicrobial therapy 3.Reduce antimicrobial resistance 4.Reduce cost of antimicrobial therapy Data is your best friend! Target problems with a high likelihood of success When in doubt, just start somewhere…

19 Common ASP Initiative Strategies Prospective Audit Interaction and Feedback Formulary Restriction Prior Authorization Other Strategies Guidelines and clinical pathways Antimicrobial cycling Antimicrobial order forms Combination therapy Streamlining or de-escalation of therapy IV to PO conversion Dose optimization Pharmacokinetic/therapeutic drug monitoring Optimal Antimicrobial Use 1. Dellit TH, et al. Clin Infect Dis 2007; 44:

20 Prospective Audit & Feedback ASP members “audit” patient charts on pre-determined, targeted patient list Time-intensive  Should balance quantity and quality Focus on patients/events with high return on investment Lists highly institution-specific Examples: high-cost antimicrobials, positive blood cultures, bug-drug mismatches Ensure complete, efficient, and feasible patient identification (CI and IT very helpful here) Baseline and ongoing data collection Interventions & Outcomes Specific-items often edited/cycled as institution’s needs evolve

21 Formulary Restriction & Preauthorization Several options to guide antimicrobial use Formulary removal (or addition) Prior authorization by ASP (or other authorized member) Pre-approved indications Prior Auth.: Consider hours of operation & staffing Off-hours protocol? On-call service needed? Compensation? Patient/event identification also crucial here Pager? ? Phone call from pharmacy? iPhone app? Baseline and ongoing data collection Consider trial periods/locations with pre-post evaluation Trial period allows comparison across time (Off-On-Off) Trial units or services allows comparison to control group

22 All strategies should incorporate education! This is the “Support” in ASST Multiple resources at local institution Pocket Antimicrobial Guidebook (antibiogram, guidelines, dosing) Website (ASST initiatives, contact info, electronic documents) Medicine & Pharmacy Grand Rounds, Noon Conference, etc. The Ultimate ASP Strategy

23 A Local ASST Experience Other ASST initiatives Antimicrobial allergy reconciliation (mainly beta-lactams) Antiretroviral inpatient service Indication-specific guidelines (e.g., gram-negative bacteremia) Drug-specific guidelines (e.g., vancomycin) IV to PO switch **Safety Surveillor® (Premier, Inc.) **Electronic chart note approved for use by P&T and MEC. **Required MEC change to allow PharmD. Formulary RestrictionProspective Audit & Feedback Pre-Approved Indications Daptomycin Linezolid Polymyxin B/Colistimethate sodium Carbapenems (pending) All Pre-Approved/Prior Authorizations Carbapenem Use > 48 hours Positive Blood Cultures MDROs (e.g., VRE, ESBLs, CREs) Prior Authorization Fidaxomicin Ceftaroline Tigecycline As time allows: Positive Urine Cultures Positive Respiratory Cultures Triple antibiotic therapy > 72 hours Vanc/Pip-tazo > 48 hours

24 What to do?... Problem Identification & Strategy Development Who will do it?... Engaging Clinicians How to do it?... Technology Why do it?... Outcomes Evaluation Key Components for ASP Initiatives

25 Direct ASP contact with prescriber Typically ID Clinical Pharmacist Phone, face-to-face Attend rounds ASP note in chart (electronic vs. paper) Permanent vs. temporary Forms committee? Ability of personnel to leave notes? Liability with recommendations Many physicians prefer documentation of recommendations in the chart ASP Communication & Documentation

26

27 ASST Prescriber

28 Indirect ASP contact with prescriber Utilize other key healthcare personnel Pharmacists Nursing Microbiology Technicians …Create culture of, “Everyone is a steward.” Utilize technology Before Rx signed at the point of CPOE After Rx signed to provide electronic feedback …Achieved through Clinical Decision Support Systems Extensions of ASP Communication

29 What to do?... Problem Identification & Strategy Development Who will do it?... Engaging Clinicians How to do it?... Technology Why do it?... Outcomes Evaluation Key Components for ASP Initiatives

30 Example of applied clinical informatics …at the point of care Clinician Patient Data Evidence-based Practices Clinical Decision Support Systems

31 Features of a Successful Clinical Decision Support System (CDSS) 1.Makes clinician’s job easier 2.Includes educational component (providing literature and important caveats) to foster user acceptance 3.Delivers patient-specific, pertinent data 5 W’s: Who to see? What data? What action? Why act? What to document? 4.Operates in real-time 1. Pestotnik SL, et al. Pharmacotherapy 2005; 25(8):

32 Features of a Successful Clinical Decision Support System (CDSS) 5.Provides online feedback and documentation within the application 6.Offers evidence-based clinical recommendations (emphasis on choice) 7.Fulfills the 6 generic uses: Alerting, interpreting, assisting, critiquing, diagnosing, and managing decision support 8.Adheres to standards for clinical terminology 1. Pestotnik SL, et al. Pharmacotherapy 2005; 25(8):

33 Third-Party CDSSs Focusing on Antimicrobial Stewardship SoftwareVendorLogo TheraDocHospira Inc. Safety SurveillorPremier Inc. MedMinedCareFusion QC PathFinderVecna Sentri7Pharmacy OneSource Inc. Allscripts McKesson 1. Kullar R, et al. Clin Infect Dis 2013; 57:

34 Advantages of CDSSs Most are designed to interface with electronic medical records (EMRs), e.g. EPIC and Cerner Generally have greater capacity for AS-specific activities than the EMR alone Alerts Reports Targeted Patient Lists Provide combined data that is typically unavailable without significant daily time and effort Cultures and susceptibilities, current antimicrobial regimens, hepatic and renal function, allergies, etc.

35 Real-Time Alerts and Reporting Local ASST experience with Safety Surveillor® (Premier, Inc.) Sample of targeted patient list by drug usage:

36

37 Barriers to Implementation & Effectiveness of CDSSs 1,2 Cost $100,000 - $500,000 per year per institution Time to implementation Committee approval, e.g. Pharmacy & Therapeutics Waiting in the IT “queue” or task list Time for maintenance Updates to formulary, clinical practice guidelines, etc. Informatics specialists for more advanced algorithms Integration into clinical workflow Alert fatigue 1.Kullar R, et al. Clin Infect Dis 2013; 57: ; 2. Njoku JC and Hermsen ED. J Pharm Pract 2010; 23:

38 CDSS Implementation for AS Pre-/post study evaluating TheraDoc implementation at the Nebraska Medical Center 1 8 alert types utilized, including: Polyantibacterials, redundant anaerobic coverage, drug-bug mismatch, vancomycin for CONS or MSSA, no positive cultures Of 10,545 alerts, only 30% were actionable overall Significant increase in interventions in the postimplementation period ASP made interventions on 75-92% of actionable alerts Decentralized pharmacists made interventions on 12% of actionable alerts Overall acceptance rate: 88% 1. Hermsen ED, et al. Infect Control Hosp Epidemiol 2009; 84:

39 CDSSs within the EMR Tools within EPIC: 1.iVents 2.96-Hour Stop Date 3.IV-to-PO Interchange 4.Antibiotic Order Forms and Dose Checking Alerts 5.Navigator and Best Practice Alerts 6.Patient Scoring and Monitoring 1. Kullar R, et al. Clin Infect Dis 2013; 57:

40 Antibiotic Order Forms Required fields for each order, assists in education and research Stewardship at the point of order verification 1. Kullar TH, et al. Clin Infect Dis 2007; 44:

41 Navigator and Best Practice Alerts ASP recommendations made as a Best Practice Alert Published evidence provided at the point of care 1. Kullar TH, et al. Clin Infect Dis 2007; 44:

42 CDSSs within the EMR Tools within Cerner: 1.Formulary Restriction and Preauthorization A.Criteria Monitored Drugs B.Special Instructions Approval 2.Prospective Audit and Feedback A.InfoView Reports B.mPages 3.Additional Strategies A.Ordersets and PowerPlans B.Antibiotic IndicationsField C.Dose Range Checks D.Promoting Education through Toolbars 1. Pogue JM, et al. Clin Infect Dis 2014; 59:

43 Cerner Tools Special Instructions Approval 1. Pogue JM, et al. Clin Infect Dis 2014; 59:

44 Cerner Tools Educational Toolbars 1. Pogue JM, et al. Clin Infect Dis 2014; 59:

45 Rapid Diagnostic Tests Novel tests that can significantly ↓ time to: Organism identification Susceptibility testing data Examples: PNA FISH MALDI-TOF PCR Nucleic acid 1.Goff DA, et al. Pharmacotherapy 2012; 32:

46 PNA FISH Yeast Traffic Light PNA FISH 1.http://www.advandx.com/AdvanDX/media/Downloads/Assay%20Overviews/YTL-PNA-FISH-Overview.png 2.http://www.advandx.com/products/pna-fish-tests/yeast-traffic-light

47 MALDI-TOF MS Analyzes 25,000 spectra in database Results in minutes Analyzes 25,000 spectra in database Results in minutes

48 What to do?... Problem Identification & Strategy Development Who will do it?... Engaging Clinicians How to do it?... Technology Why do it?... Outcomes Evaluation Key Components for ASP Initiatives

49 Outcome Measures Antimicrobial usage Days of Therapy (DOT), Defined Daily Doses (DDD) Cost avoidance/savings Antimicrobials, laboratory, hospitalizations Resistance patterns Antibiogram trends HospitaI-acquired infection rates C. difficile-associated diarrhea Multidrug-resistant organisms, or MDROs Clinical endpoints Mortality, length of stay

50 Outcomes with MALDI-TOF & ASP in Bloodstream Infections (BSIs) Pre-post quasi-experimental study at University of Michigan Hospitals and Health System Evaluated clinical outcomes in 501 adult patients with BSIs over 3-month periods before and after intervention Intervention: MALDI-TOF identification (ID) reported 6:00am-11:30pm Blood subcultured and incubated overnight prior to analysis ASP activities Real-time alerts for (+) blood cultures via TheraDoc Recommendations according to local guidelines at time of (1) Gram stain, (2) organism ID, and (3) susceptibility testing results 1.Huang AM, et al. Clin Infect Dis 2013; 57:

51 Outcomes with MALDI-TOF & ASP in Bloodstream Infections (BSIs) Intervention showed significant ↓ in time to: Organism ID (55.9 vs h, p<0.001) Effective therapy (20.4 vs h, p=0.021) Optimal therapy (47.3 vs h, p< 0.001) 1.Huang AM, et al. Clin Infect Dis 2013; 57:

52 Outcomes with MALDI-TOF & ASP in Bloodstream Infections (BSIs) Intervention also showed significant ↓ in: 30-day all-cause mortality (12.7% vs. 20.3%, p=0.021) Length of ICU stay (8.3 vs d, p=0.014) Recurrence of same BSI (2.0% vs. 5.9%, p=0.038) 1.Huang AM, et al. Clin Infect Dis 2013; 57:

53 Local ASST Case: Daptomycin Early local ASST initiative Curbing overuse expected to address ALL of the ASST goals 215 courses of therapy in ~69% inappropriate use (e.g., MRSA without reason, VRE in urine) One of the top local drug expenditures ($283,656 in FY 2012)

54 Local ASST Case: Daptomycin : Fosfomycin E-testing on urinary VRE isolates Oct-Nov 2012: Fosfomycin added to formulary; Prospective audit of VRE(+) urine cultures May 2013: Daptomycin ordering restricted to PowerPlan Required selection of a pre-approved indication 1. Staphylococcus aureus with high vancomycin MIC ( > 2 mcg/mL) 2. Vancomycin-resistant Enterococcus (VRE) from non-urinary source 3. Documented vancomycin allergy, NOT Red Man’s Syndrome 4. Vancomycin therapy failure (Consider ID consult) 5. Other indication: ASST prior approval required (off-hours ordering reviewed the next business day)

55 Local ASST Case: Daptomycin Daptomycin PowerPlan CPK monitoring included in PowerPlan

56 Local ASST Case: Daptomycin FY 2012 $283,656 FY 2013 $163,266 FY 2014 $145,969 Daptomycin PowerPlan, 5/13 Fosfomycin on-formulary & VRE urine audits, 10-11/12 2 patients on 6+ weeks of dapto FY 2012FY 2013FY 2014

57 Local ASST Case: Carbapenems Carbapenem overuse a significant problem Utilization rates high (internal data from the institution) Risk factor for infections due to carbapenem-resistant Enterobacteriaceae (CREs) 1,2 Risk factor for C. difficile infections (internal data) ASST Initiatives Jul 2013: Prospective audit of carbapenem use > 48 hours Inappropriate Use: De-escalation or discontinuation Appropriate Use: Stop date suggested, dose optimization Beta-lactam allergy reconciliation Jan 2014: Gram-negative Bloodstream Infection Management Local guidelines published Prospective audit of positive blood cultures initiated MALDI-TOF initiated 1.Hussein, et al. Infect Control Hosp Epidemiol 2009; 30: Falagas, et al. J Antimicrob Chemother 2007; 27:

58 GN BSI No carbapenems first-line

59 Local ASST Case: Carbapenems Acceptance Rate: 82% (93/113)

60 DOT per 1000 patients-days Meropenem shortage Audit of >48h carbapenem Time period GN BSI Guideline & Audit Local ASST Case: Carbapenems

61 Audit of >48h carbapenem CRE incidence rate per 100,000 patient-days Time period GN BSI Guideline & Audit

62 Local ASST Case: Carbapenems Future strategies pending implementation Cerner Tools: Antibiotics Indications Field

63 Summary Optimal antimicrobial use is the ultimate goal Effective stewardship teams are interdisciplinary, including CI and IT Key components to consider for hospital ASP initiatives: (1) Problem & Strategy, (2) Clinician Engagement, (3) Technology, and (4) Outcomes Evaluation Many examples of successful ASP initiatives exist Growing number utilize innovative tools, e.g., clinical decision support and rapid diagnostic tests

64 Antimicrobial Stewardship and Support Team (ASST) Joseph Kohn, PharmD, BCPS P. Brandon Bookstaver, PharmD, BCPS (AQ-ID), AAHIVP Julie Ann Justo, PharmD, MS, BCPS, AAHIVP Palmetto Health Richland Palmetto Health Richland Palmetto Health Baptist & Parkridge Palmetto Health Baptist & Parkridge Katie DeVaul, PharmD Majdi Al-Hasan, MBBS ASST Director Majdi Al-Hasan, MBBS ASST Director Acknowledgments …And the rest of the PH ASST Team!

65 Critical Antimicrobial Stewardship Program Components for Success Julie Ann Justo, PharmD, MS, BCPS, AAHIVP Assistant Professor, South Carolina College of Pharmacy ID Clinical Specialist, Palmetto Health Richland October 24, nd Annual APIC Palmetto Educational Conference

66 CDSSs & Stewardship IDSA/SHEA guidelines also comment: “Computer-based surveillance can facilitate good stewardship by more efficient targeting of antimicrobial interventions, tracking of antimicrobial resistance patterns, and identification of nosocomial infections and adverse drug events (B-II).” 1. Dellit TH, et al. Clin Infect Dis 2007; 44:

67 Rapid Diagnostic Tests TechnologyTime (h)Trade Name(s) (Manufacturer) Polymerase chain reaction (PCR)0.75-3, 6*Xpert (Cepheid), FilmArray (Biofire), BD GeneOhm (BD GeneOhm), Progastro Cd (Gen-Probe desse), LightCycler SeptiFast Test MGRADE* (Roche Molecular Systems) Peptide nucleic acid fluorescence in situ hybridization (PNA FISH) 1.5GNR Traffic Light PNA FISH (AdvanDx), Yeast Traffic Light PNA FISH (AdvanDx) Bacteriophage amplification5.5KeyPath MRSA/MSSA Blood Culture (MicroPhage) Nucleic acid2.5Verigene (Nanosphere) Loop-mediated isothermal amplification (LAMP) 1illumigene C. difficile (Meridian Bioscience) Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry (MS) 0.2MALDI Biotyper (Bruker Daltonics) VITEK MS (bioMérieux) 1.Goff DA, et al. Pharmacotherapy 2012; 32: * Direct from blood prior to culture

68 Rapid Diagnostic Tests 1.Goff DA, et al. Pharmacotherapy 2012; 32: Microorganisms/Resistance Mechanisms Gram-Positive Bacteria Staphylococcus spp.: aureus, epidermidis, lugdunensis Streptococcus spp.: anginosus Group, agalactiae, pneumoniae, pyogenes Enterococcus spp.: faecalis, faecium Clostridium difficile Resistance Mechanisms: mecA, vanA, vanB Gram-Negative Bacteria Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Pseudomonas aeruginosa Serratia marcescens Resistance Mechanisms: KPC, NDM, CTX-M, Acinetobacter spp. Proteus spp. Citrobacter spp. Enterobacter spp. VIM, IMP, OXA Fungi Candida spp.: albicans, glabrata, krusei, parapsilosis, tropicalis Aspergillus fumigatus Viruses Adenovirus Norovirus Rotavirus

69 MALDI-TOF MS 1 cartridge = 4 slides = 192 isolates per run 1.Deposit bacteria or yeast 2.Add matrix solution(s) 3.Analyze → result within minutes 1 isolate per spot 48 spots per slide

70 Other Technologies Websites 1 Many ASP resources from leading academic medical center are publicly available Johns Hopkins Health System The Nebraska Medical Center Valuable local marketing tool Smartphone apps 2 iPhone/iPad or Android Iodine Alert System Potential educational tool for ID topics 1.Gauthier TP, et al. Clin Infect Dis 2014; 58: Moodley A, et al. Clin Infect Dis 2013; 57:

71 Outcomes with PNA FISH for Candida Test implementation significantly reduced time to: Identification of C. albicans Median 9.5 h vs. 44 h, p< Median 0.2 d vs. 4 d, p< Targeted therapy 2 Mean 0.6 vs. 2.3 d, p= Culture clearance 2 Median 4 d vs. 5 d, p=0.01 Cost savings estimated at $415-1,837 per patient treated 1-3 Mainly due to decreased drug costs, i.e. switch from echinocandins to fluconazole 1.Forrest GN, et al. J Clin Microbiol 2006; 44: Heil EL, et al. Am J Health Syst Pharm 2012; 69: Alexander BD, et al. Diag Microbiol Infect Dis 2006; 54:

72 Local ASST Case: Daptomycin


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