Antimicrobial Stewardship A case-based approach Disclosures: Consultant for Actelion, prior research studies with Cerexa, Merck, Cubist Sarah Doernberg, MD, MAS Outline Warm-up Warm-up exercise Find someone sitting next to you Why is antimicrobial stewardship important? 2 minutes: Think about a time where you think antibiotic management could have gone better. Please share with the person What is stewardship? sitting next to you and share what factors contributed Stewardship cases Then, summarize with 1-2 words and write on your index card ASP case studies • E.g. Treated viral infection with antibiotics due to pressure from patient Family pressure, treatment of non-bacterial infection 1 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
Factors contributing to imperfect Almost 40% of inpatients receive antibiotics on a given day antibiotic management • In 2006, 63.5% of patients at 35 University Health System Consortium hospitals received at least one dose of antibiotics during their hospitalization Arch Intern Med. 2008 Nov 10;168(20):2254-60. 30% of inpatient antibiotic use is 30% of outpatient use is unnecessary! unnecessary 58% received ≥ 1 day of unnecessary antibiotics Over 12% of outpatient visits result in an antibiotic Spectrum not Redundant 1 outpatient antibiotic indicated coverage prescription per every 2 4% 10% people annually Noninfectious or nonbacterial Only half of rx’s for 33% Adjustment not respiratory conditions were made estimated to be needed 3% Duration too Colonization or long contamination 34% 16% Fleming-Dutra KE et al. JAMA. 2016 May 3;315(17):1864-73. https://www.cdc.gov/media/releases/2016/p0503- Hecker MT et al . Arch Intern Med. 2003;163:972-978. unnecessary-prescriptions.html 2 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
Sir Alexander Fleming, Prevailing attitude from another Nobel 1945 Nobel Prize Lecture Prize winner, Sir Frank MacFarlane Burnet “If one looks around the medical scene in North America or Australia, the most important current change he sees is the rapidly diminishing importance of infectious diseases . The fever hospitals are vanishing or being turned to other uses. With full use of the knowledge we already possess, the effective control of every important infectious disease , with the one outstanding exception of poliomyelitis, is possible” https://www.nobelprize.org/nobel_prizes/medicine/laureates/1945/fleming-lecture.pdf Pier GB. Clin Infect Dis 2008; 47: 1113-1114 Timeline of antibiotic resistance CDC’s top drug-resistant threats Urgent Serious Concerning C. difficile MDR Acinetobacter VRSA CRE Drug-R Campylobacter Erythromycin-R Gp A Strep Drug- resistant gonorrhea Fluc-R Candida Clinda-R Gp B Strep ESBL VRE MDR Pseudomonas Drug-R Salmonella Drug-R Shigella MRSA Drug-R Strep pneumo MDR/XDR TB https://www.cdc.gov/drugresistance/biggest_threats.html http://chicago-mosaic.medill.northwestern.edu/antibiotic-resistance-superbugs/ 3 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
Timeline of drug development “Last resort” antibiotics are endangered NDA/BLA IND review review Clinical development FDA filing, Pre-human approval, research launch Phase I Phase II Phase III preparation Year 0 Year 5 Year 10 Presehttps://www.cdc.gov/media/releases/2016/s0531-mcr-1.htmlntation New approved antimicrobials in the US From the IOM 18 “The absence of new classes in 16 14 the pipeline… is alarming when 12 one considers the ever-increasing 10 number of antibiotic-resistant 8 6 organisms.” 4 2 0 1983- 1988- 1993- 1998- 2003- 2008- 1987 1992 1997 2002 2007 2011 Smolinski MS, et al., 2003. Adapted from Spellberg B et al., 2004; Boucher et al., 2009 4 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
Current pipeline is looking up 87% of physicians agree that AMR is a public health problem, but… http:// http://www.pewtrusts.org/en/multimedia/data-visualizations/2016/the-critical-need-for-new-antibiotics Metlay JP, et al. J Gen Intern Med. 2002;17:87-94. Risk avoidance depends on the clinical Antibiotic use also varies by prescribers population Metlay JP, et al. J Gen Intern Med. 2002;17:87-94. Laxminarayan et al., Science 2016 5 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
% of people in Europe rx’d for cold/flu/sore throat ranges from 11% to 81% Validated national cultural dimensions explain almost half of this antibiotic variation So what can be done to improve • Uncertainty avoidance • Extent the society tolerates our antibiotic use? uncertainty and ambiguity • Masculinity • Distribution of emotional roles between genders • Assertive and competitive http://ecdc.europa.eu/en/healthtopics/antimicrobial-resistance-and-consumption/antimicrobial-consumption/esac-net- database/Pages/geo-distribution-consumption.aspx Borg MA. J Antimicrob Chemother 2012;67:763-768 What is antimicrobial stewardship? The stewardship program Interventions designed to optimize the appropriate use of antimicrobials P+T Key assumptions Quality • Prescribing behaviors and Pharmacy Improve Safety can be changed patient • Antimicrobial use is a ASP outcomes primary driving force in the development of AMR IT Clinical • ↓ in antimicrobial use systems Services Decrease will ↓ resistance antimicrobial • Appropriate use resistance HEIC improves patient outcomes and reduces Decrease costs costs MacDougall C and Polk RE. Clin Microbiol Rev. 2005;18:638-56. 6 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
Opportunities for stewardship What are the requirements for antimicrobial stewardship? 6/2016 the Joint Commission announced a new Antimicrobial Stewardship standard which will be evaluated starting 1/2017 Diagnostic work-up for suspected infection CMS has issued a proposed rule that would mandate ASPs in Empirical therapy started Guidelines acute care and critical access hospitals as a Condition of Definitive therapy Stewardship of laboratory Institutional guidelines Participation (CoP) in the Medicare Program testing Antibiogram available Prospective audit and Rapid diagnostics Computerized decision feedback support Antibiotic time-out Allergy testing Guidelines Formulary restriction Cascade reporting Prospective audit and Pharmacy interventions feedback Automatic stops CARB California Department of Public Health: Abuse Antibiotics, Go to Jail “By 2020, significant outcomes of Goal 1 will include: • Establishment of antibiotic 2008: Senate Bill (SB) 739 stewardship programs in all acute • “…all general acute care hospitals develop processes for evaluating the judicious use of antibiotics and monitor results using appropriate quality care hospitals and improved improvement committees“ antibiotic stewardship across all • No enforcement provisions or funding healthcare settings. 2010: SB 739 Enforcement • Reduction of inappropriate • Medical lead for ASP hired, development of ASP programs antibiotic use by 50% in • Evaluation of SB 739 compliance – without consequences outpatient settings and by 20% in 2014: SB 1311 inpatient • Adopt and implement ASP policy, identify MD and PharmD leads, ensure formal ASP training, report activities to hospital quality settings.” • “… violation…constitutes a misdemeanor punishable by a fine not to exceed $1,000, by imprisonment in a county jail, or by both that fine and imprisonment.” Slide courtesy of Conan MacDougall, PharmD https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic- Trivedi K, Rosenberg J. Infect Control Hosp Epidemiol 2013;34:379-384 http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140SB1311 resistant_bacteria.pdf 7 2/2/2017 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
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