Antibiotic Mindfulness - Becoming Better Stewards of a Precious Resource

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1 Antibiotic Mindfulness - Becoming Better Stewards of a Precious Resource Paul J. Carson, MD, FACP Dept. of Public Health, Management of Infectious Diseases

2 April 2010

3

4 CDC Hazard Level for Antibiotic Resistance Threats Urgent Serious Concerning Clostridium difficile (C. diff) MRSA VRSA Carbapenem-R Enterobacteraciae VRE Ery-R GABHS Drug-resistant N. gonorrhoeae MDR-Pseudomonas Clinda-R GBBHS ESBL-Enterobaceraciae DR-Campylobacter DR-Salmonella Fluconazole-R Candida sp MDR-Acinetobacter MDR/XDR TB

5 Rise in U.S. Clostridium Difficile Infection

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8 Estimated 50 million unnecessary outpt antibiotic prescriptions per year CDC

9 Antibiotic Prescriptions Per 1000 Persons by State NEJM Apr 2013

10 Trends in Hospital Antibiotic Use Study of 22 academic medical centers from with claims data 64% of all discharged patients received abx during hosp n There was a 7% overall increase in use of abx over time period Vancomycin use up 43% - most commonly used drug in latter 2 yrs of study Carbapenem use up 59% Pipracillin-Tazobactam use up 84% Quinolones overall were most frequently used class Estimated 30-50% of inpatient antimicrobial use is inappropriate Hecker MT, et al. Arch Intern Med2003:163: Pakyz AL, et al. Arch Intern Med. 2008;168(20):

11 Approved Antibiotics in U.S # of 8 New 6 Abx 4 2 0

12 Frequency of ADEs due to Antibiotics in Outpatient Setting 142,505 estimated emergency department visits/year due to untoward effects of antibiotics (~ 1:1000 abx prescriptions) Antibiotics account for 19.3% of drug related adverse events 78.7% for allergic events 19.2% for adverse events (e.g. diarrhea, vomiting) Approximately 50% due to penicillin & cephalosporin classes 6.1% required hospital admission NEISS-CADES project Bourgeois, et al. Pediatrics. 2009;124;e Linder. Clin Infect Dis Sep 15;47(6):744-6 Vangay, et al. Cell host & Microbe 2015;17; Shehab N et al. Clin Infect Dis. 2008;47:735

13 Consequences of Hospital Antibiotic Use At one tertiary care center 70% of Medicare patients received an antibiotic in 2010 Approximately 50% of this use was unnecessary or inappropriate Untoward consequences of antibiotic therapy identified in this and other studies: Inadequate treatment of infection Increased hospital readmissions ADEs Polk et al. In: PPID, 7 th ed Luther, Ohl. IDSA Abstract 2011

14 Human Microbiome Human Cells Bacterial Cells

15 Diversity of Bacteroides Species in Gut After 7 day Course of Clindamycin Microbiology (2010), 156,

16 Dysbiosis Obesity Auto-immune dz Metabolic syndrome Diabetes IBD Asthma Allergy Autism

17 Call for Antimicrobial Stewardship American Academy of Pediatrics American Society of Health-System Pharmacists Infectious Diseases Society for Obstetrics and Gynecology Society for Hospital Medicine Society of Infectious Diseases Pharmacists Society for Healthcare Epidemiology of America Infectious Diseases Society of America Centers for Disease Control and Prevention

18 Dreyden et al. J Antimicrog Chemoth, Ohl CA, Luther VP. J. Hosp. Med. 2011;6:S4 Dellit TH, et. al. Clin Infect Dis. 2007;44: What Is Antimicrobial Stewardship? Antibiotic stewardship refers to a set of coordinated strategies to improve the use of antimicrobial medications with the goal of enhancing patient health outcomes, reducing resistance to antibiotics, and decreasing unnecessary costs (SHEA) A system of informatics, data collection, personnel, and policy/procedures which promotes the optimal selection, dosing, and duration of therapy for antimicrobial agents throughout the course of their use Right drug, right time, right dose, right duration

19 2013 Template and icons provided by The Advisory Board Company. Regulatory and Cost Imperatives for Antimicrobial Stewardship

20 8 Elements of Performance 1. Leaders establish antimicrobial stewardship program as an organizational priority 2. Educates staff involved in abx ordering/dispensing/administration on resistance and stewardship practices. Upon hire and periodically thereafter. 3. Educates patients and families as needed re: appropriate use of abx (e.g. GetSmart) 4. Multi-disciplinary team including ID/IP/Ph/Practitioners 5. Program has 7 core CDC elements (next slide) 6. ASP uses organization-approved multidisciplinary protocols (e.g. formulary restrictions, appropriateness assessments, C diff care, abx use guidelines, IV-PO conversion, preauth requirements 7. ASP collects/analyzes/reports data on a regular basis 8. Hospital takes action on improvement opportunities identified by its ASP 2013 Template and icons provided by The Advisory Board Company.

21 CDC Guidelines 7 Core Elements Leadership commitment - dedicating necessary human, financial, and IT resources to the program Accountability - leader who is responsible for program outcomes Drug expertise - pharmacist in charge of working to improve abx use Action - implementing one or more CDC-recommended actions Education - teaching clinicians and relevant staff about abx resistance and optimal prescribing habits Tracking - monitoring patterns of prescribing and resistance Reporting - relaying information on abx use and resistance within institution on a regular basis 2013 Template and icons provided by The Advisory Board Company.

22 CMS Carrots and Sticks Value Based Purchasing metrics Dollars at risk based on performance Losers give up money to winners Hospital Acquired Conditions (HACS) Financial penalties for adverse events occurring during hospitalization 6/14 HACS are related to infections New rule for all hospitals to develop an ASP as a condition of participation o o o o o o HAC 6: CAUTI HAC 7: Vascular catheter associated infection HAC 8: SSI Mediastinitis after CABG HAC 11: SSI Bariatric surgery HAC 12: SSI Certain orthopedic procedures of spine, shoulder, and elbow HAC 13: SSI Post cardiac implantable electronic device procedures Proposed NHSN SAAR measure (standardized antimicrobial administration ratio) as part of future VBP 2013 Template and icons provided by The Advisory Board Company.

23 Sanford Enterprise Dollars at Risk for P4P Measures % at Risk: $ at Risk - Total $ at Risk Infections % at Risk - Infections Value Modifier Program (future MIPS) 4% Provider $5,500,000 $145, % MN Blue Cross Blue Shield Quality Risk Contract N/A $6,361,000 $2,544,400 40% Value-Based Purchasing (VBP) Program 2% Inpatient $4,385,000 $789,300 18% FY 2018 Hospital Readmissions Reduction Program 3% Inpatient $7,068,000 $1,178,000 17% Hospital Acquired Conditions (HAC) Reduction 1% Inpatient $2,900,000 $2,465,000 85% End Stage Renal Disease Quality Improvement 2% $313,000 $56,350 18% TOTAL N/A $26,527,000 $7,178, % Fargo Region Infection-Related P4P at Risk Dollars = $3,799, Template and icons provided by The Advisory Board Company.

24 Attributable Hospital Cost Associated with Select HAIs (in 2012 $) HAI Attributable Cost MRSA SSI $42,300 MRSA CLABSI $58,614 VAP $40,144 C. Difficile infxn $11,285 CAUTI $896 JAMA Intern Med, Sept 2013 Costs adjusted to 2012 dollars

25 Efficacy of Antimicrobial Stewardship Programs

26 Valiquette, et al. Clin Infect Dis 2007;45:S112. Targeted antibiotic consumption and Nosocomial C. difficile disease Tertiary care hospital; Quebec,

27 Percent Antibiotic Stewardship Improves Clinical Outcomes AMP UP Appropriate Cure Failure Resistance RR 2.8 ( ) RR 1.7 ( ) RR 0.2 ( ) Fishman N. Am J Med 2006;119:S53. AMP = Antibiotic Management Program UP = Usual Practice

28 How About Us?

29 Antimicrobial Use and Costs at MeritCare/Sanford DDD/1000 pt days Abx $ / pt day 575 Abx $ Per Pt-Day DDD Per 1000 Pt-Days FY 03 FY 04 FY 05 FY

30 Top Abx Used at Sanford/Fargo by DDD ,000 DDD Vancomycin Pip/Tazo Cipro Levo Ceftriaxone Metronid Linezolid Erta Flu Mero Cefepime Dapto

31 New Hospital-Acquired Cases / 1000 Pt-Days Incidence of Hospital Acquired Infections at MeritCare/Sanford Hospital MRSA VRE C. difficile

32 Pharmacist Initial Report Adult Pt. Appropriate Tx. Appropriate Pre-op Abx ID Physician ~20-30 reviews/day Patients ID consults Need More Info Recommendations Appropriate Tx. Review Later No Further Review

33 Antimicrobial Use and Costs Before and After ASP Inception 26.0 ASP Intervention DDD / 1000 Pt-days Abx $ / Pt-days Projected Abx$ / Pt-days FY 03 FY 04 FY 05 FY 06 FY 07 FY 08 FY 09 FY

34 New Hospital-Acquired Cases / 1000 Pt-Days 1.2 Incidence of Hospital Acquired Infections at MeritCare/Sanford Hospital ASP Intervention MRSA VRE C. difficile p <

35 Antimicrobial Costs at MeritCare/Sanford and Projected Savings Since ASP Inception in 2007 Year Total Abx Expenditures Patient Days Abx $ / Ptday Actual Savings c/w FY 06 a Projected Abx $ / Pt-day b Projected Cost Savings c FY 06 $1,758,433 92,873 $18.93 ref FY 07 $1,657,295 96,990 $17.09 $174,582 $20.70 $350,134 FY 08 $1,729, ,667 $17.18 $171,133 $22.60 $545,615 FY 09 $1,579,291 91,798 $17.20 $156,056 $24.50 $670,125 FY 10 $1,707,946 91,494 $18.67 $29,278 $26.30 $698,099 Total Estimated Savings Since ASP Inception $2,263, a ( FY 06 Abx$/Pt-day - Current year Abx$/Pt-day) x Pt-days b Based on projections by linear regression of trend rise in costs for c (Projected Abx$/Pt-day Current year Abx$/Pt-day) x Pt-days

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37 Note: I only showed you data through What s the rest of the story?

38 Do doctors need one more set of people riding herd on them and making their life more difficult?

39 Or Evil? Are doctors just being stupid?

40 Public Health and Institutional Interests Patient s Interests

41 Need to Consider All Aspects of Care of the Patient Costs of therapy Likelihood of promoting resistance Overuse of antibiotics Institutional and Public Health Interests I can improve all of that by not treating anybody with an infection - or, by giving old, cheap,? efficacious, and more toxic drugs!!! Most efficacious treatment for the ill Least toxic therapy Patient s Interests

42 Clinical Outcomes Before and After ASP-Inception for Intra-abdominal Sepsis and Pneumonia Outcome Pre-ASP n = 122 Intra-abdominal Sepsis (n=225) Post-ASP n = 103 Survival 90% 95% 0.17 Length of Stay Mean (S.D.) 7.22 (7.1) 7.37 (8.3) p-value 0.52 Readmission Rate a 19.5% 16.7% 0.58 Outcome Pre-ASP n = 1163 Pneumonia (n=2186) Post-ASP n = 1023 Survival 96% 96% 0.85 Length of Stay Mean (S.D.) 5.9 (4.9) 5.5 (7.8) p-value 0.21 Readmission Rate a 14.6% 14.6% 0.97 a Readmission for any reason within 30 days

43 HOW WAS THE ASP PERCEIVED?

44

45 Acceptance of ASP Among Sanford Physicians Survey sent to hospitalists, medical specialists treating inpatients, residents, and surgeons 64 returned survey in 2008, 22 in % said ASP notes were almost always helpful 29% said notes were somewhat helpful < 1% said not helpful 99% respondents wished ASP to continue on their patients

46 Acceptance Rate of ASP Recommendations - Sanford Met with hospitalists - Epic implementation %

47 2013 Template and icons provided by The Advisory Board Company. Targeting Outlier Prescribers?

48

49 What Can We Target in a 2 Mini-Consult?

50 Questions to Ask on Every Case Is it really an infection? Are abx warranted? Is the source healthcare-acquired or community-acquired? Are they giving empiric vs definitive Rx? What is the narrowest spectrum drug(s) they can give to accomplish the goal? Have they set the right duration? 2013 Template and icons provided by The Advisory Board Company.

51 Keep in Mind the Big Picture Goals Reducing broad spectrum agents, esp the carbapenems and quinolones, unless definite indication Reducing very expensive antibiotics (Ceftaroline, Daptomycin, Lipo Ampho) What is data showing for particular target or focus areas in your region? Are there outlier departments or physicians that merit special attention 2013 Template and icons provided by The Advisory Board Company.

52 Infected? No Raise Question 2-MINUTE CONSULT Yes HCA or CA Empiric Definitive Guidelines Cx data & Guidelines Right Abx?* Right Abx?* Possible Actions: 1) Intervene 2) Revisit when more data 3) OK Revisit near end of expected duration *Allergies *Dosing *Abx history/filter 52

53 Common Infectious Diseases and Areas for Potential Improvement Cellulitis / SSTI Intra-abdominal infection Pneumonia UTI

54 What Actually Happens: Choice of Antibiotics for Uncomplicated Cystitis in FP Clinics in Dallas 2013 Template and icons provided by The Advisory Board Company. Grigoryan L. Open Forum Infect Dis, 2015

55 Antibiotic Resistance Trends in E. coli Urinary Isolates n = 12,253,679 Sanchez GV. Antimicrob Agents Chemother Template and icons provided by The Advisory Board Company.

56 Risks with Use of the Quinolones Condition Achilles tendon rupture Current exposure overall Age Age > 80 Relative Risk 4.3 (95% CI, ) 6.4 (95% CI, ) 20.4 (95% CI, ) Serious arrhythmia 2.43, 95% (CI, ) Death 1-5 d after Levofloxacin 2.49 (95% CI, ) Aortic dissection 2.43 (95%CI, ) C. Diff infection 12.7 (95% CI, ) 2013 Template and icons provided by The Advisory Board Company. Risk of acquiring MRSA 3.0 (95% CI 2.5 to 3.5) (c/w 1.8 RR for other abx) Van Der Linden. JAMA Int Med 2003 Gowtham. Ann Fam Med. Apr 2014 Chien-Chang. JAMA Int Med 2015 McCusker. Emerg Infect Dis 2003 Tacconelli. JAC 2008

57 Duration of Therapy It May Be Shorter Than You Think! Disease COPD exacerbation CAP HCAP, HAP Cellulitis UTI Cystitis UTI Pyelonephritis Peritonitis Duration of Treatment 5 days 5-7 days 8 days 5-10 days 5 days (macrodantin) 3 days (TMP-SMX, quinolones) 5 days (quinolones) 14 days (TMP SMX, or B- lactam) 4-7 days after source control 2013 Template and icons provided by The Advisory Board Company.

58 Role of the Pharmacist in AMS They clinically screen drugs as part of their everyday practice Antimicrobial therapeutic drug monitoring advice and guidance Assist in writing antimicrobial guidelines and policies Making anti-infective formulary decisions Attending ward rounds on specialties with high antibiotic use Best positioned people to gather data on institutional antimicrobial use and patterns Key member of multi-disciplinary prospective AMS teams Oversee OPAT May be in best position to assess and intervene in outpatient AMS 2013 Template and icons provided by The Advisory Board Company.

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