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Antimicrobial stewardship: A Concern for all Practitioners

Antimicrobial stewardship: A Concern for all Practitioners. David J. Feola, Pharm.D., Ph.D., BCPS Assistant Professor University of Kentucky College of Pharmacy. Modern Healthcare, August 7, 2006, page 36 – Protesting infections from MRSA. Hospital Acquired Infections: Pennsylvania 2007.

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Antimicrobial stewardship: A Concern for all Practitioners

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  1. Antimicrobial stewardship:A Concern for all Practitioners David J. Feola, Pharm.D., Ph.D., BCPS Assistant Professor University of Kentucky College of Pharmacy

  2. Modern Healthcare, August 7, 2006, page 36 – Protesting infections from MRSA

  3. Hospital Acquired Infections: Pennsylvania 2007 • Patients without infection • Mortality = 2.0% • Length of stay = 4.7 days • Average Charge = $37,943 • Patients with hospital-acquired infection • Mortality = 12.2% • Length of stay = 19.7 days • Average Charge = $191,872 PA Health Care Cost Containment Council, November 2008

  4. Learning Objectives • 1. Summarize the impact of antimicrobial resistance on clinical and economic outcomes in various patient populations. • 2. Summarize the goals of antimicrobial stewardship programs in health-systems and the role of health care practitioners in such programs. • 3. Explain two core strategies essential for the implementation of antimicrobial stewardship initiatives.

  5. Presentation Overview • Why antimicrobial management is essential • What is antimicrobial stewardship • IDSA Guidelines: Definition • The Antimicrobial Management Team • How to implement/role of practitioners • Recommendations • The University of Kentucky experience

  6. Why Stewardship is Needed • Antimicrobial resistance results in • Increased morbidity/mortality • Increased healthcare costs • Practices in antimicrobial use often inadequate, not routinely implemented • Up to 50% antimicrobial prescribing inappropriate • Causal relationship between antimicrobial use and emergence of resistance

  7. A Disturbing Trend CBP; DAL; New Entities Limited Sulfa, BL, AG, Chloramphenicol TCN, MAC, Vanc, RIF, FQ, TMP No new classes. Modification of existing agents. LZD, DAP, TIG PCN-resistant S. aureus MRSA VRE VISA in 7 states MDR Pseudomonas and Acinetobacter, metallo-beta-lactamases, carbapenemases LZD-R S. aureus VRSA Half of US and Japanese companies END drug discovery 1950 1970 1940 2010 1960 2000 1930 1980 1990

  8. The Critical Balance Importance of appropriate empiric therapy Effect of broad-spectrum therapy on resistance Mortality increases when initial therapy is inappropriate Resistance increases when broad-spectrum agents are needed; Resistance has a negative impact on outcomes “Collateral damage”

  9. Appropriate Initial Therapy Affects Outcomes Effect of broad-spectrum therapy on resistance Importance of appropriate empiric therapy *Difference in mortality not significant. LOS significantly increased

  10. Antimicrobial Use and Resistance • Changes in use parallel changes in resistance • Resistance higher in healthcare-associated infections • Patients with resistant infections more likely to have received prior antimicrobials • Hospital areas of highest resistance associated with highest antimicrobial use • Increased duration of therapy increase likeliness of colonization with resistant organisms Shales DM et al. CID 1997;25:584-99.

  11. ESBL Production and Outcomes • Non-urinary tract isolates of Klebsiella, E. coli • Length of stay • 21 days vs. 11 days (P=0.006) • Clinical success • 48% vs. 86% (P=0.027) Importance of appropriate empiric therapy Effect of broad-spectrum therapy on resistance and outcomes Lee, et al. Inf Cont Hosp Epi 2006;27:1226-32

  12. MRSA and Outcomes • MRSA vs. MSSA bacteremia • Clinical Failure: 59.6% vs. 33% (P<0.001) • Length of Stay (infection-related): 20.1 vs. 13.7 days (P<0.001) • Mortality (infection-related): 30.6% vs. 15.3% (P=0.001) Importance of appropriate empiric therapy Effect of broad-spectrum therapy on resistance and outcomes Lodise T and McKinnon P. Diag Microbiol Inf Dis 2005;52.

  13. VRE and Outcomes • VRE bacteremia • Decreased survival: 24% vs. 59% • Length of Stay: 34.8 vs. 16.7 days • Attributable cost: $27,190 • VRE bloodstream meta-analysis • Mortality increase: 30% Importance of appropriate empiric therapy Effect of broad-spectrum therapy on resistance and outcomes Stoser V et al. Arch Int Med 1998;158:522-7 DiazGranados CA et al. CID 2005;41:327-33. Salgado CD et al. Inf Contr Hosp Epid 2003;24:690-8.

  14. P. aeruginosaResistance Obritsch MD, et al. Antimicrob Agents Chemother. 2004;48:4606-4610

  15. Correlation: Use and Resistance Lepper PM et al. Antimicrob Agents Chemother 2002;46:2920-5.

  16. Fluoroquinolones • Ciprofloxacin—selection of resistant isolates when appropriate pharmacodynamic parameters are not met (AUC/MIC) • Pseudomonas aeruginosa (All fluoroquinolones) • Methicillin-susceptible Staph aureus • Streptococcus pneumoniae Garcia-Rey C et al. Clin Microbial Infect 2006;12:55-66 Jacobi GA. Clin Infec Dis 2005;41:S120-6 Cook PP et al. J Hosp Infect 2006:54:341-58.

  17. Pseudomonas aeruginosaCiprofloxacin Resistance Trends (1989-1999) Source: The Surveillance Network (TSN), Focus Technologies And for 2003, NNIS Survey. AJIC 2003

  18. 3rd Generation Cephalosporins • Cause/associated with several different problems in the hospital (oximinocephalosporins) • Extended-spectrum beta-lactamases • Selection of stably derepressed isolates in SPACE bacteria • Selection of vancomycin-resistant enterococcus – particularly E. faecium • Contribution to MRSA • Increased cases of Clostridium difficile associated diarrhea/colitis Dancer SJ. J Antimcirobial Chemother 2001; 48: 463-478

  19. Carbapenems: Emerging Resistance • Meropenem and P. aeruginosa • Up-regulation of MexA-MexB-Oprm (efflux pump) • Loss of the OprD protein (porin channel) • Both mutations needed for resistance development • MIC 0.12–0.5 µg/ml (before mutation) • MIC 2-4 µg/ml (with one mutation) • MIC >8 µg/ml (with both mutations) Livermore D. JAC 2001; 47: 247-250

  20. Resistant Pathogen Infection Antimicrobial Resistance AntimicrobialUse Perilous Cycle: KPC Example ESBL-producing E. coli, K. pneumo, SPACE Unknown pathogen ESBL-producing bacteria KPC KPC-producing infection Oximinocephalosporins ESBL production Carbapenems Carbapenemase development ?????

  21. Economic Impact of Resistance • S. aureus bacteremia • Methicillin resistance: 100% greater cost of therapy • Klebsiella and E. coli infections • ESBL production: 66% greater cost of therapy • Pseudomonas aeruginosa infections • Imipenem resistance: 68% greater cost of therapy Lodise T and McKinnon P. Diag Microbiol Inf Dis 2005;52. Lee, et al. Inf Cont Hosp Epi 2006;27:1226-32. Lautenbach, et al. Inf Cont Hosp Epi 2006;27:893-90.

  22. Definition: Antimicrobial Stewardship • Infection control plus antimicrobial management • Appropriate antimicrobial selection, dosing, route, and duration • System selection of antimicrobials that cause the least collateral damage • MRSA • ESBLs • Clostridium difficille • Stable derepression • Metallo-beta-lactamases and other carbapenemases • VRE

  23. Guideline Resources • IDSA and SHEA • Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship • Dellit TH et al. CID 2007;44:159-77 • Centers for Disease Control • Management of Multidrug-Resistant Organisms in Healthcare Settings • http://www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline2006.pdf • ASM and SHEA • Antimicrobial Resistance Prevention Initiative—An Update • Moellering RC et al. Am J of Inf Contr 2007;35:S1-23

  24. Role of Infection Control • Infection control trumps everything else • Hand hygiene – must have hand washing police • Barrier precautions • Devotion to all aspects of strict infection control • Nursing staff • Medical staff • Medical staff leadership

  25. Infection Control – is it cost effective? InfectionCost Savings VAP $25,072 Bacteremia $23,242 Surgical Site infection $10,443 Urinary Tract Infection $ 758 Anderson, et al. Infect Control Hosp Epidem 2007;28:767-73

  26. Goals of Antimicrobial Stewardship • Primary goal • Optimize clinical outcome/minimize unintended consequences of antimicrobial use • Unintended consequences: • Toxicity • Selection of pathogenic organisms • Emergence of resistant pathogens • Secondary goal • Reduce healthcare costs without adversely impacting quality of care

  27. Core Members of the Team • Infectious disease physician (Director or Co-director) • Clinical pharmacist with infectious disease training (Co-director or core member) • Other members of the team • Microbiologist • Information system specialist • Infection control professional • Hospital epidemiologist

  28. IDSA Grading System for Ranking Recommendations in Clinical Guidelines Kish MA et al. CID 2001; 32: 851 - 4

  29. Active Core Strategies • Prospective audit with intervention and feedback to reduce inappropriate antimicrobial use (A-I) • Formulary restriction and pre-authorization leading to reductions in antimicrobial use and cost (A-II) NOTE – neither of these strategies are mutually exclusive

  30. Assessments • Antimicrobial consumption • Defined daily dose • Cost • Days of treatment • Antimicrobial adverse events • Resistance patterns/development • Intervention monitoring Patel D et al. Exp Rev Anti Infect Ther 2008; 6:209-22

  31. Assessments • Clinical outcomes measurements • Antimicrobial appropriate • Cure vs. failure • Clinical • Microbiologic • Superinfections • Reinfection • Resistance development Fishman N. Am J Inf Contr 2006;34:S55-63

  32. Elements for Consideration and Prioritization • Parenteral to oral conversion (A-I) • When the patient’s condition allows • Decrease length of stay • Decrease healthcare costs • Development of clinical criteria and guidelines allowing conversion to use of oral agents (A-III)

  33. Elements for Consideration and Prioritization • Streamlining or de-escalation therapy (A-II) • Based on culture results and elimination of redundant therapy • Decreases antimicrobial exposure and cost • Dose optimization (A-II) • Based on PK/PD parameters and includes patient characteristics, causative organism, site of infection, in addition to PK/PD characteristics of the drug

  34. Elements for Consideration and Prioritization • Educational programs, active intervention (A-III, B-II) • Provides foundation of knowledge • Guidelines and clinical pathways – seek multi-disciplinary involvement and approval (A-I) • Incorporate local antimicrobial resistance patterns (A-I) • Provide education and feedback to practitioners (A-III)

  35. Elements for Consideration and Prioritization • Antimicrobial order forms (B-II) • Shown to be effective component of the program and can facilitate implementation into practice • Combination therapy • Insufficient data for routine use (C-II) • Has a role to increase coverage in empiric therapy in patients at risk for multi-drug resistant pathogens • Antimicrobial cycling – is not recommended because of insufficient data (no ranking)

  36. Research Priorities/Future Directions • Antimicrobial Cycling • Validation of mathematical models of resistance • Long-term impact of formulary restrictions • Focusing interventions on “collateral damage issues” • Development of more rapid susceptibility tests • Bad bugs/no drugs – stimulate research • Counteract inappropriate detailing

  37. Critical Success Factors Identified • Collegial and educational relationship • Daily review of antimicrobial orders by a consistent accountable team • Support of hospital/medical leadership • FTE’s dedicated to program (Pharm.D. and MD) • Development of criteria and guidelines for anti-infective use • Formulary restriction • Education of prescribers to insure compliance

  38. STAAR • The Strategies to Address Antimicrobial Resistance Act • Develop an Office of Antimicrobial Resistance within DHHS • Coordinate a plan for addressing the problem of antimicrobial resistance • Create Public Health Advisory Board • Create Antimicrobial Resistance Research and Strategic Plan • Collection of antimicrobial drug utilization data in humans and animals • Development of a clinical research and public health network • Award grants • Endorsed by SIDP, IDSA, SHEA, PIDS, AMA, APHA, APIC, NFID, APUA, and ACP

  39. The University of Kentucky Experience: Antimicrobial Stewardship 1998-2008 • Control prescribing • Vancomycin • Reduce 3rd generation cephalosporin use • Select a single fluoroquinolone (not ciprofloxacin) • Select a single carbapenem • Antimicrobial Management Team • Physician , Pharmacist hired (2001) • Data collection • Pathways for empirical antimicrobial use • ICU specific antibiograms • Minimize the use of TPN Martin, et al. AJHP 2005; 62: 732 - 738

  40. Prevalence of MRSAUniversity of Kentucky Hospital AMT program begins

  41. Antibiotic Cost/Patient DayUniversity Hospital Consortium: Top 7 * Active Antimicrobial Team – ID Physician and Pharmacist

  42. AMT versus No AMT • UHC antibiotic cost/patient day • No antimicrobial management team - $19.80 • With antimicrobial management team - $12.83 • $19.80 - $12.83 = $6.97/patient day • UKMC in 2004 had 114,983 patient days • Est. cost savings = $801,438/year

  43. Antimicrobial Costs at UK $8,188,456 $1,793,723

  44. UKMC: Current Challenges • Linezolid prescribing • No data proving better than vancomycin • Multinational trial in progress • Acinetobacter • Clonal outbreak • Back to baseline—rolling ICU shutdown • MRSA • Rates increasing • CA-MRSA responsible

  45. Where to Begin • Chief of ID, Director of Pharmacy • Develop initial budget proposal • Present to hospital administration • Include financial and microbiology goals • Form Antimicrobial Subcommittee to P&T • Hire physician and pharmacist • Develop practice guidelines/pathways • Buy in and implement

  46. Summary and Conclusions • Antimicrobial Stewardship programs show great promise and offer new opportunities for patient care and cost impact • Recommendation by both IDSA/ASHP and the CDC offer firm foundations to obtain support and funding for antimicrobial stewardship programs • Huge opportunity for advancement of clinical pharmacy practice

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