Antimicrobial Stewardship: The Never Ending Journey

1. Antimicrobial Stewardship: The Never Ending Journey Joan Ivaska, BS, MPH, CIC Sr Director, Infection Prevention Banner Health System December 12, 2013

2. About Banner Health • 24 Acute Care Hospitals • Banner Health Network • Banner Medical Group with >800 doctors • Banner Health Centers and Clinics • Behavioral Hospital • Outpatient Surgery • Medical Education • 2012 inpt. admissions/year: 241,646 • 2012 ED visits/year: 733,976 • 2012 surgeries/year: 133,532

3. Defining clinical practiceat Banner Health Care Management Council • Make systemwide clinical decisions • Members include CMOs, CNOs, team leaders • CM Clinical Consensus Groups • Determine clinical practices based on best available evidence • Identify opportunities for improving clinical care • Define expected and recommended clinical practices for Banner Health based on best available evidence. • Oversee how clinical practices will be performed and implemented • Define, Design, and Implementation phases • Reviews, revises and approves clinical order sets

4. Objectives • Discuss the importance of an antimicrobial stewardship program • Review the SHEA/IDSA/PIDS Antimicrobial Stewardship Policy Statement and recommendations • Review Banner Health’s approach to antimicrobial stewardship

5. Antibiotic Use, Costs, andFinancial Outcomes • Annually in United States • 30% hospital admissions due to infection 1 • 2 million people develop HAI2 • 23,000 of these individuals die as a direct result of this infection 5 • 30-50% hospitalized pts receive ABX 1,2 • 200‐300 million antibiotics are prescribed annually • Up to 50% ABX orders are unnecessary or inappropriate 1-3 • 30% of hospital pharmacy budget is composed of antimicrobials 4 • > $1.1 billion spent annually on unnecessary antibiotic prescriptions for respiratory infections in adults 5 • $15 million to treat 188 cases of ABX resistant infections 5 • Attributable costs 4 • MRSA: $9,275 - $13,901 • VRE: $27,190 per episode • Resistant Enterobacter: $29,379 1 Gums JG et al. Pharmacotherapy 1999;19:1369-77. 2 Owens Jr RC et al. Pharmacotherapy 2004;24:896-908. 3 Arnold FW et al. J Manag Care Pharm 2004;10:152-58. 4 Dellit TH et al. Clin Infect Dis 2007;44:159-77. 5 www.cdc.gov/getsmart/healthcare/inpatient-stewardship.html 6 Centers for Disease Control and Prevention, Antibiotic Resistant Threats in the United States, 2013.

6. Decline in the Number of New Antibacterial Agents Approved in the USA, 1983-20121 Percent Decline in Approved Antibiotics Compared With 1983-1987 (n=16 new agents) 1988-1992 1993-1997 1998-2002 2003-2007 2008-2012 0 -10% -20% -30% -40% -50% -60% -70% -80% -90% 14 10 7 5 2 In 2002, out of 89 new drugs, no new antibiotics were approved 2 Numbers in arrow bars represents # of new antimicrobials approved by the FDA during the 5-year period listed 1 Boucher H et al. Clin Infect Dis 2009;48:1-12 (up to 2007) 2 Infectious Diseases Society of America. Bad Bugs, No Drugs. July 2004. Available at: www.idsociety.org

7. Publically Available Information on Antibiotic Resistance: “A National Call to Action” http://www.consumersunion.org/campaigns/stophospitalinfections/learn.html

8. Factors That Lead to Inappropriate Use of Antibiotics Internal External Lack of time to educate patients and prescribers about when antibiotics are not indicated Lack of microbiologic data (and acquisition of it) Fear of malpractice for not giving an antibiotic Misperception that antibiotics have only benefit and no harm Pharmaceutical detailing - new does not always equal better • Lack of knowledge of infectious diseases, e.g., “more antibiotics are better” • “Double coverage is better for killing” • “Expanding” spectrum when consolidation is better • Lack of knowledge about antibiotics • What agents cover what pathogens- broader is easier; vancomycin as “broad spectrum” • Lack of knowledge about dosing-, e.g., “low dose for longer is better” • Lack of knowledge of antibiotic allergies and their implications • Lack of knowledge about when to give and stop antibiotics • Prophylaxis outside of surgical theater

9. CDC 12 Steps to Prevent Antimicrobial Resistance in Hospitalized Adults Prevent Infection 1. Vaccinate 2. Get the catheters out • Diagnose and Treat Infection Effectively • Target the pathogen • Access the experts • Use Antimicrobials Wisely • Practice antimicrobial control • Use local data • Treat infection, not contamination • Treat infection, not colonization • Know when to say “no” to vancomycin • Stop treatment when infection is cured or unlikely • Prevent Transmission • 11. Isolate the pathogen • Break the chain of contagion In a joint study with the CDC, John Hopkins and Univ Louisville Univ Hospital, 87% of potential interventions fit into one of the CDC’s 12-steps, and following staff education, the rate of compliance with recommendations to improve antimicrobial use was 72% 1 CDC slides available at: www.cdc.gov/drugresistance/healthcare/ha/slideset.htm 1 Cosgrove S, et al. Infect Control Hosp Epidemiol. 2007;28:641-6

10. Impact of Antibiotic Stewardship Programs McQuillen D, et al. Clin Infect Dis.2008;47:1051-63

11. SHEA / IDSA / PIDS Policy Statement, 2012 • Antimicrobial Stewardship Programs should be required through regulatory mechanisms • Antimicrobial Stewardship should be monitored in ambulatory healthcare settings • Education about antimicrobial resistance and antimicrobial stewardship must be accomplished • Antimicrobial use data should be collected and readily available for both inpatient and outpatient settings • Research on antimicrobial stewardship is needed

12. IDSA Antibiotic Stewardship GuidelinesDellitTH, et al. Clin Infect Dis. 2007;44:159-77 Definition: Judicious use of antimicrobials in order to improve patients outcomes, control resistance and decrease healthcare expense Achieved through:

13. The Banner ANTIMICROBIAL STEWARDSHIP Plan–ADULT & PEDIATRIC Six Components: • Formulary Restriction • Treatment guidelines/clinical pathways • Computer surveillance and clinical decision support • Education • Auditing of Antimicrobial use • A centralized system team for antimicrobial stewardship oversight

14. Purpose ofAntimicrobial Stewardship • Guide antimicrobial therapy usage to minimize toxicity, decrease emergence of resistance and selection of pathogenic organisms and improve / optimize patient care.

15. Clinical Proposal • Overview: All inpatients will be treated with the appropriate antimicrobial agent(s) to optimize clinical outcomes while minimizing unintended consequences of antimicrobial use. • Rationale: • the use of antimicrobial medications can be associated with unintended consequences including: drug toxicity, super infection with Clostridium difficile, and emergence of resistant organisms. • inappropriate use of antimicrobials remains a common occurrence in health care facilities contributing to increased costs • antimicrobial resistance results in increased morbidity, mortality and health care costs • Effective antimicrobial stewardship programs can improve patient care by optimizing the appropriate use of antimicrobials, resulting in improved patient outcomes and decreased costs.

16. Formulary Restrictions • Antimicrobials may by restricted based on therapeutic efficacy, toxicity, and to minimize antimicrobial resistance and cost. • Antimicrobial therapeutic substitution • e.g., ceftaz to cefepime; caspo to micafungin; ambisome to abelcet, 1st and 2nd generation cephalosporins • Develop Discern alerts to guide appropriate use of high-cost/broad spectrum agents • Use caresets to guide appropriate use of antimicrobial medications (e.g. sepsis)

19. Discern Website

20. Treatment Guidelines/Clinical Pathways • Treatment guidelines and clinical pathways will be developed incorporating evidence-based practice and local microbiology and resistance patterns. • CCG Clinical Practices/Initiatives such as CAP, Sepsis • De-escalation of empirical antimicrobial therapy based on culture results so as to eliminate redundant therapy and targeting the causative pathogen. • Clinical Decision Support Discern Alerts • Dose optimization based on individual patient characteristics, causative organism, site of infection and drug characteristics. • Pharmacy Renal Dosing Protocol • Parenteral to oral conversion when the patients condition allows. • Pharmacy IV to PO Conversion Protocol

21. Computer Surveillance and Clinical Decision Support • Computer-based surveillance will provide clinical decision support to optimize clinical outcomes while minimizing unintended consequences of antimicrobial use. • Prescriber Discern alerts for restricted antimicrobials to provide recommendations and record usage of selected antimicrobials. • Pharmacy Discern alerts to identify potentially inappropriate/suboptimal antimicrobial therapy based on microbiology results and/or renal function

22. Education • Education is an essential element for influencing prescribing behaviors and will be partnered with active interventions for greatest effectiveness (on-going education). • Antimicrobial Stewardship SharePoint site will provide information related to Antimicrobial Stewardship at Banner.

23. Auditing Antimicrobial Use • Retrospective audits of clinical decision support antimicrobial alerts at both a system and facility level • Additional prospective or retrospective audits dependent on individual facility capabilities • Audits to be performed by appropriate clinical personnel, including infectious disease physician, clinical pharmacist, infectious disease practitioner or other personnel as determined by facility capabilities • Metrics measured may include usage patterns, patient outcomes, resistance trends • Prescribers who repeatedly utilize selected antimicrobials inappropriately will require intervention and feedback.

24. A centralized system team for Antimicrobial Stewardship Oversight Oversight Team to review the effectiveness of facilities and system implementation of the Banner Antimicrobial Stewardship Plan and to determine opportunities for improvement.

27. Partnering Opportunities

28. Expected Outcomes • Antimicrobial Stewardship to become part of daily clinical practice for all healthcare professionals • Full compliance with restricted uses for select antimicrobials • Pharmacy evaluation, provider follow-up when indicated and complete documentation of pharmacy antimicrobial Discern alerts. • Completion of Pharmacy Audits and Provider follow-up • Cost savings associated with antimicrobial use

29. Banner Health Discern Data

30. Developing an Antibiotic Stewardship Program:The Core Team and Supporting Stakeholders Support Team Information Technology Infection Control Quality Assurance/ Patient Safety Hospital Epidemiologist Microbiology Core Team Clinical Pharmacist with ID Training Infectious Disease Physician Collaborative Team Med Executive & Pharmacy and Therapeutics Committees Hospital Administration & Pharmacy Director AZ Partnership for ASP, 2012

31. How to Get Started • Essential components for successfulASP • Support and collaboration of hospital administration, medical staff leadership, and local providers • Function as a quality assurance and patient safety initiative • Coordinate activities between key stakeholders (e.g. Infectious Diseases, Pharmacy, Infection Control and Microbiology) • Collaborate and obtain adequate authority to perform activities • Identify expected outcomes for the program Dellit TH, et al. Clin Infect Dis. 2007;44:159-77

32. Twelve Steps to Implementing an ASP

33. Accounting for theNon-Academic Medical Center Comprehensive program led by ID physician or physician champion, plus clinical pharmacist Individual interventions based on goals of institution, with assistance from interested individuals • Formulary management strategies: • Simple audit (review of orders) of specific drugs - 10 patients • Pharmacy order entry system (unsophisticated) • Develop evidenced-based guidelines for 3-4 agents (see IDSA guidelines as a start) • Educate medical staff (2-minute “elevator speech”) • All pharmacists can apply guidelines and approve drugs • Post-prescription review on days 2-3 with physician champion • IV-to-PO conversion is a good demonstration project • SCIP guidelines and other performance outcomes and measures

34. Barriers…Perceived and Real:Infectious Diseases Pharmacist • Dilemma • The number of “ID-trained” clinical pharmacists doesn’t match the demand, nor do the number of training programs • Requiring completion of a post-graduate ID training program to administer stewardship would be an impediment at present • Possible solutions: • Financial and administrative support for in-house and external programs and training • Programs developed by professional organizations • “Tool kits” to direct baseline activities and enhance existing ones • Best practice sharing (e.g. round tables, web-based) • Partner with other clinical pharmacy specialist colleagues and/or staff pharmacist to accomplish any or all components Ernst EJ et al. Pharmacother 2009;29:482-88.

35. Computer Decision Support Systems (CDSS): Programmable Dashboards • Programming current computer systems may assist in targeting antibiotic prescribing activities • Commercial systems (~8) are available for purchase at an appreciable cost

36. Keys to Success • One size does not fit all • Perform a baseline assessment of assets, deficits; gather pilot data • Address any deficits that will impede the basic program and fix first • Pre-determine barriers: differentiate the real from the misunderstood • Pro-actively address the valid obstacles • Prioritize available resources as well as additional resources needed • Choose reasonable, sequential initiatives that are practical and beneficial to the institution and will lead to a logical progression of next steps • Bring in the specialists but realize everyone has a stake in the program…involve them, encourage them, educate them, report back to them (good and bad) • Cost-reduction of the antimicrobial budget is not a primary justification for antimicrobial stewardship, but cost-savings will be realized from AST activities • Create a campaign towards antibiotic stewardship

37. Patient Evaluation Choice of antimicrobial to prescribe Prescription ordering Dispensing of antimicrobial Antibiotic Stewardship: Lessons Learned Education/guideline strategies “Several strategies, including prescriber education, formulary restriction, prior approval, streamlining, antibiotic cycling, and computer-assisted programs have been proposed to improve antibiotic use. Although rigorous clinical data in support of these strategies are lacking, the most effective means of improving antimicrobial stewardship will most likely involve a comprehensive program that incorporates multiple strategies and collaboration among various specialties within a given healthcare institution.” 1 Antibiotic cycling strategies Formulary/restriction strategies Computer-assisted strategies Review and feedback strategies Figure adapted from: MacDougall C et al.. ClinMicrobiol Rev. 2005;18(4):638-56. 1 Fishman N. Am J Infect Control. 2006;34:S55-63.

38. In Closing…