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Enhancing Antibiotic Stewardship in Acute Care Hospitals September 7, 2011 1:00-2:30pm

Building Stewardship: A Team Approach. Enhancing Antibiotic Stewardship in Acute Care Hospitals September 7, 2011 1:00-2:30pm. Importance and Impact of Antimicrobial Stewardship Hosp Pharm 2010;45(11 Suppl 1):S1-S5. Antimicrobial Therapy.

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Enhancing Antibiotic Stewardship in Acute Care Hospitals September 7, 2011 1:00-2:30pm

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  1. Building Stewardship: A Team Approach Enhancing Antibiotic Stewardship in Acute Care HospitalsSeptember 7, 2011 1:00-2:30pm

  2. Importance and Impact of Antimicrobial Stewardship Hosp Pharm 2010;45(11 Suppl 1):S1-S5

  3. Antimicrobial Therapy Appropriate initial antibiotic while improving patient outcomes and heathcare Unnecessary antibiotics and adverse patient outcomes and increased cost A Balancing Act

  4. Antimicrobial Prescribing Empiric • Initial administration of a broad-spectrum antibiotic regimen that attempts to improve outcomes and minimize resistance. Defined or Targeted • Modification of antimicrobial therapy once the cause of infection is identified. Therapy may also be discontinued if the diagnosis of infection becomes unlikely.1 • Focus on de-escalation of antibiotic therapy with the goal of minimizing resistance and toxicity, and improving cost-effectiveness.2,3 1. Kollef MH. Drugs. 2003;63:2157–2168. 2. Kollef MH. Crit Care Med. 2001;29:1473–1475. 3. Evans RS et al. N Engl J Med. 1998;338:232–238.

  5. Bad Bugs: No ESKAPE • Enterococcus • S. aureus • Klebsiella spp. • Acinetobacter • P. aeruginosa • Enterobacter spp. Boucher H, et al, Clin Infect Dis 2009;48:1-12

  6. What is Antimicrobial Stewardship • Antimicrobial stewardship involves the optimal selection, dose and duration of an antibiotic resulting in the cure or prevention of infection with minimal unintended consequences to the patient including emergence of resistance, adverse drug events, and cost. Ultimate goal is improved patient care and healthcare outcomes Dellit TH, et al. CID 2007;44:159-77, Hand K, et al. Hospital Pharmacist 2004;11:459-64 Paskovaty A, et al IJAA 2005;25:1-10 Simonsen GS, et al Bull WHO 2004;82:928-34

  7. Containment and Antimicrobial Resistance Surveillance Simonsen GS, et al . Bull WHO 2004;82:928-34

  8. ASHP Statement on ASP 2009 Promoting optimal antimicrobial use Reducing the transmission of infections

  9. What Every Health Care Executive Should Know: The Cost of Antimicrobial Resistance • Antimicrobial Resistance: Patients and hospitals in Peril • The Clinical Consequences of Antimicrobial Resistance • Transmission Control to Prevent the Spread of MDROs in Health Care Facilities • Antimicrobial Stewardship Joint Commission Resources 2009

  10. Building The Team Infectious Diseases Specialists Infection Control Administration Antimicrobial Control Microbiology ClinicalPharmacists Pulmonary/ Intensivist OR Personnel Nursing Surgical Infection Experts/Surgeons

  11. Antimicrobial Stewardship Strategies • Prospective audit with intervention and feedback • Formulary restriction and preauthorization Supplemental Strategies • Education, guidelines, clinical pathways • Dose optimization via PK-PD • De-escalation/Streamlining • Antimicrobial order forms/order sets if CPOE • IV-PO switch • Computerized decision support • Others Dellit TH, et al. CID 2007;44:159-77 Hand K, et al Hospital Pharmacist 2004;11:459-64 Paskovaty A, et al IJAA 2005;25:1-10

  12. Antimicrobial Stewardship Care Bundle • Prospective audit system • Stewardship program • Outcomes • Reason for treatment, cultures, empirical, and de-escalation • LOS, mortality, and % interventions accepted IV to Oral interchange Toth NR, et al Am J Health-Syst Pharm 2010;67:747-9

  13. Computer Surveillance and Decision Support in Antimicrobial Stewardship • Sentri7 • SafetySurveillor • TheraDoc • Computerized physician order entry • Benchmarking and local antimicrobials point prevalence surveys (state may consider doing this) Claridge JA, et al. Surg Infect 2010;11:125-31

  14. Education

  15. Antimicrobial Order Forms

  16. Benefits of a HAP Protocol at Tufts Medical Center Lancaster JW, et al. Pharmacotherapy 2008;28(7):852-62

  17. What Is the Appropriate Duration of Therapy for cIAI? • Antimicrobial therapy of established infection should be limited to 4–7 days, unless it is difficult to achieve adequate source control • Bowel injuries due to penetrating, blunt, or iatrogenic trauma repaired within 12 h and any other intraoperative contamination of the operative field by enteric contents should be treated with antibiotics for <24 hours Lack of evidence of infections includes, being afebrile, have normal WBC, and tolerating an oral diet.

  18. Diagnostic and Pathogen Identification Techniques • Biomarkers • Procalcitonin • CRP • PNA FISH • PCR • E-test of patient samples Lawrence KL, et al. Am J Respir Crit Care Med 2009;198:434-8 Cals JWL, et al. Ann Fam Med 2010;8:124-33 Schuetz R, et al. JAMA 2009;302:1059-66 Bouza E, et al CID 2007;44:382-7

  19. Measuring the Effectiveness of an Antimicrobial Stewardship Program • Antimicrobial usage • Days of therapy • Appropriateness of treatment • Antimicrobial cost • Bacterial susceptibilities • Patient outcomes • Antimicrobial adverse events • Acceptance of recommendations • Prescribers surveys

  20. The Public is Aware of Antimicrobial Resistance

  21. Infectious Disease Society of America’s

  22. How to Make Antimicrobial Stewardship Work: Practical Considerations for Hospitals of All SizesHosp Pharm 2010;45(11 Suppl1):S10-S18

  23. Objective of Paper Provide advice on some of the practical aspects of starting a new stewardship program or expanding an existing program, with special commentary regarding the unique challenges facing community and teaching institutions.

  24. Formation of the Antimicrobial Stewardship Team • The members of the team have to fit the personal available • Staff physician with ID interest • P&T chair or committee member • Hospitalist with interest in ID • Non–ID-trained clinical pharmacist • Staff pharmacists (with certification in stewardship)

  25. Program Goals and Processes • Performing selected stewardship activities should be considered successful • Helping patients is the goal, not struggling to follow guidelines at the expensive to a successful program for your institution • Lines of authority and reporting are key • Quality and Safety • P&T for assistance with P&P and protocol approval

  26. Process Metrics (Measuring Success) • Outcome Metrics • CMS outcomes (CABP and SCIP) • Percentage of appropriate IV to PO • Point prevalence of antimicrobial use • Percent of appropriate antimicrobial regimens • Percent of patients with VAP or ABSSTI treat according to protocol (antimicrobial and non-antimicrobial metrics) • Antibiogram changes over time • Process Metrics • Percent of recommendations accepted (numbers and type) • CMS outcomes

  27. Consideration for Community Hospitals • Challenges faced by Community Hospitals • Lack of sufficient resources • Private ID or NO ID physicians (or those that do not want to be involved) • ID pharmacist • No extra staff (especially pharmacy) • On site laboratory for C&S data • Antibiograms which include non-formulary agents • No IT systems for data gathering or analysis • Dealing with non-compliant prescribers • Embrace use of non-traditional stewardship personnel

  28. Putting Stewardship into Practice • One the program is approved the following should be determined • What activities will be performed? • By which person? • How frequently? • With what authority? • What is the time line for reporting the data? • Advertise, market and educate direct care providers about the programs (think grass roots politics) • Notify clinicians about changes that impact the program • Report program successes and failures • Share data with individual prescribers /departments when possible

  29. Pharmacokinetics and Pharmacodynamics of Antimicrobials: It’s Not Just for Mice AnymoreClinical Infectious Diseases 2007; 45:S89-95

  30. Pharmacokinetic/Pharmacodynamic Parameters • Provide descriptors of antimicrobial activity profiles • Provide surrogate markers to predict drug activity • Integrate “bug” and “drug” data PK/PD Antimicrobial Pathogen Host

  31. Different Drugs Impact Bugs Differently • β-lactams • “not much happens until an adequate proportion of PBP are occupied” • Smaller doses, more frequently • Prolonged or continuous infusion • Time>MIC • Aminoglycosides/Fluoroquinolones • AUC:MIC • Cmax/MIC • Dose AND MIC matter

  32. Defining Targets • β-lactams (stasis and near maximal killing) • Cephalosporins: 35% and 65% • Carbapenems: 20% and 40% • Penicillins: 30% and 50% • Fluoroquinolones (stasis and near maximal killing) • AUC/MIC: 20-25 and 250-300 • Ambrose et al in CABP: 30 needed for clinical cure • HAP/VAP: AUC/MIC for levofloxacin 87 need for micro cure

  33. Relationship between different measures of drug exposure and the microbiological effect a mouse model of pneumonia

  34. Concentration vs. Time-dependence

  35. Best represented by Time>MIC Optimal Time>MIC varies Usually at least 40% of dosing interval >50% in neutropenia Time-dependent Killing Concentration Time>MIC MIC Time

  36. Concentration-dependent Activity • Best represented by Cmax:MIC ratio • Cmax:MIC ratio >8-12 associated with clinical success • Optimal ratio varies with drug and organism Concentration Cmax:MIC MIC Time

  37. Concentration-dependent Activity 80mg/kg q24h 40mg/kg q12h 20mg/kg q6h Control • Dose-fractionation experiment with lomefloxacin in an animal model • Same total dose given as different regimens Lode, et al. Clin Inf Dis 1998;27:33-9

  38. AUC/MIC Ratio – MIC component • Varies by particular isolate of organism • “Same drug, different bug” • Ex. Ciprofloxacin vs. Pseudomonas Cipro-resistant Cipro-sensitive Concentration AUC/ MIC MIC=4 mcg/mL AUC/ MIC MIC MIC<1 mcg/mL Time

  39. AUC/MIC Ratio – AUC component • Traditional pharmacokinetic parameter • Calculated based on total serum concentrations of drug • Obtained by sampling at multiple time points and integrating under curve Concentration Time

  40. AUC/MIC Ratio – AUC component • Surrogate for AUC of unbound drug at site of infection…at receptor site • Does not account for susceptibility of organism • Difficult to measure in clinical practice Effective Assayed Protein Binding Entry into infected site Access to bacterial target

  41. Monte Carlo simulation: applied to PK/PD models Random pharmacokinetics and MIC values from dataset AUC MIC Calculate pharmacodynamic parameter Plot results in a probability chart AUC:MIC Dudley & Ambrose. Curr Opin Microbiol2000;3:515−521

  42. Determining probability of target attainment in the patient population • Monte Carlo simulation • determine distribution of antimicrobial potency (eg MIC distribution) • determine distribution of antimicrobial exposures (eg AUCs) • computer program randomly selects parameters from each of the distributions (500, 5000… iterations = patients) and the probability distribution of achieving the preset level (pharmacodynamic target attainment = specific AUC:MIC or T>MIC) is computed Nicolau & Ambrose. Am J Med 2001;111(9A):13S–18S

  43. AUC/MIC Ratio • May be a better surrogate marker of activity than drug exposure (AUC) or MIC alone • Studies have shown AUC/MIC to be predictive of antimicrobial activity Probability of developing resistance during treatment for nosocomial pneumonia Thomas, et al. Antimicrob Agents Chemo 1998;42:521-7.

  44. Clostridium difficile (CD) • Gram-positive anaerobic bacteria • Exotoxin producing • Fecal-oral transmission • C. difficileinfection (CDI) onset median 2-3 days • Most common cause of infectious diarrhea • 20-30% of antibiotic-associated diarrhea • Infect Control Hosp Epidemiol. 2010; 31(5): 431-55. • Centers for Disease Control and Prevention

  45. Background: Pathogenesis of CDI 1. Ingestion of spores transmitted from other patients via the hands of healthcare personnel and environment 3. Altered lower intestine flora (due to antimicrobial use) allows proliferation of C. difficile in colon 4. Toxin A & B Production leads to colon damage +/- pseudomembrane 2. Germination into growing (vegetative) form Sunenshine et al. Cleve Clin J Med. 2006;73:187-97.

  46. CDI Risk Factors • Age • Hospital duration • Antibiotic usage • Chemotherapy • Gastrointestinal disruption • Infect Control Hosp Epidemiol. 2010; 31(5): 431-55.

  47. CDI Diagnosis • Diarrhea • 3 or more unformed stools • Positive stool test • Enzyme immunoassay vs. polymerase chain reaction • Pseudomembranous colitis • Colonoscopic or histopathologic findings • Infect Control Hosp Epidemiol. 2010; 31(5): 431-55.

  48. CDI Classification • Infect Control Hosp Epidemiol. 2010; 31(5): 431-55.

  49. CDI Treatment • Discontinue any potential causative agent • Immediately initiate empirical treatment • Severe or complicated • Data of probiotic usage is inconclusive • Not recommended for primary prophylaxis • Infect Control Hosp Epidemiol. 2010; 31(5): 431-55.

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