Antimicrobial Stewardship Collaborative Monthly Conference Call March 19, 2013 12:00pm – 1:00pm

1. WELCOME Antimicrobial Stewardship Collaborative Monthly Conference Call March 19, 2013 12:00pm – 1:00pm Deb Quetti, RN MBA, BSN, CPHQ Project Manager, Qualidigm

2. Agenda for Today’s Call • Welcome and review of agenda:  D. Quetti • Powerpoint presentation on California’s mandatory requirements for antibiotic stewardship programs:  Mike Rinaldi, PharmD, Waterbury Hospital • DPH update: R. Melchreit, MD • “Long-term care assessment of AMS practices” GNYHA survey:  participation rates and final results:  D. Quetti • Status report on conferring process for NHSN rights and “group” formation:  D. Quetti • Status report on Community progress to date (scope of work, participants, successes and barriers):  community leaders • Farmington • Manchester • Meriden • Middlesex • New Britain • Waterbury • Suggestions for future conference call topics:  all participants • Developing an elevator speech • Proposed date for collaborative wrap up session:  Thursday, July 25, 2013 • Proposed next monthly call:  Tuesday, April 23, 2013 at 12 noon

3. <?xml version="1.0"?><AllQuestions /> <?xml version="1.0"?><AllResponses /> <?xml version="1.0"?><Settings><answerBulletFormat>Numeric</answerBulletFormat><answerNowAutoInsert>No</answerNowAutoInsert><answerNowStyle>Explosion</answerNowStyle><answerNowText>Answer Now</answerNowText><chartColors>Use PowerPoint Color Scheme</chartColors><chartType>Horizontal</chartType><correctAnswerIndicator>Checkmark</correctAnswerIndicator><countdownAutoInsert>No</countdownAutoInsert><countdownSeconds>10</countdownSeconds><countdownSound>TicToc.wav</countdownSound><countdownStyle>Box</countdownStyle><gridAutoInsert>No</gridAutoInsert><gridFillStyle>Answered</gridFillStyle><gridFillColor>255,255,0</gridFillColor><gridOpacity>50%</gridOpacity><gridTextStyle>Keypad #</gridTextStyle><inputSource>Response Devices</inputSource><multipleResponseDivisor># of Responses</multipleResponseDivisor><participantsLeaderBoard>5</participantsLeaderBoard><percentageDecimalPlaces>0</percentageDecimalPlaces><responseCounterAutoInsert>No</responseCounterAutoInsert><responseCounterStyle>Oval</responseCounterStyle><responseCounterDisplayValue># of Votes Received</responseCounterDisplayValue><insertObjectUsingColor>Red</insertObjectUsingColor><showResults>Yes</showResults><teamColors>Use PowerPoint Color Scheme</teamColors><teamIdentificationType>None</teamIdentificationType><teamScoringType>Voting pads only</teamScoringType><teamScoringDecimalPlaces>1</teamScoringDecimalPlaces><teamIdentificationItem></teamIdentificationItem><teamsLeaderBoard>5</teamsLeaderBoard><teamName1></teamName1><teamName2></teamName2><teamName3></teamName3><teamName4></teamName4><teamName5></teamName5><teamName6></teamName6><teamName7></teamName7><teamName8></teamName8><teamName9></teamName9><teamName10></teamName10><showControlBar>All Slides</showControlBar><defaultCorrectPointValue>0</defaultCorrectPointValue><defaultIncorrectPointValue>0</defaultIncorrectPointValue><chartColor1>187,224,227</chartColor1><chartColor2>51,51,153</chartColor2><chartColor3>0,153,153</chartColor3><chartColor4>153,204,0</chartColor4><chartColor5>128,128,128</chartColor5><chartColor6>0,0,0</chartColor6><chartColor7>0,102,204</chartColor7><chartColor8>204,204,255</chartColor8><chartColor9>255,0,0</chartColor9><chartColor10>255,255,0</chartColor10><teamColor1>187,224,227</teamColor1><teamColor2>51,51,153</teamColor2><teamColor3>0,153,153</teamColor3><teamColor4>153,204,0</teamColor4><teamColor5>128,128,128</teamColor5><teamColor6>0,0,0</teamColor6><teamColor7>0,102,204</teamColor7><teamColor8>204,204,255</teamColor8><teamColor9>255,0,0</teamColor9><teamColor10>255,255,0</teamColor10><displayAnswerImagesDuringVote>Yes</displayAnswerImagesDuringVote><displayAnswerImagesWithResponses>Yes</displayAnswerImagesWithResponses><displayAnswerTextDuringVote>Yes</displayAnswerTextDuringVote><displayAnswerTextWithResponses>Yes</displayAnswerTextWithResponses><questionSlideID></questionSlideID><controlBarState>Expanded</controlBarState><isGridColorKnownColor>True</isGridColorKnownColor><gridColorName>Yellow</gridColorName></Settings> <?xml version="1.0"?><AllAnswers /> Legislative Updates in Antimicrobial Stewardship Mike Rinaldi, PharmD Infectious Diseases Pharmacist Waterbury Hospital

4. Disclosures • Served on scientific Advisory Boards for Pfizer and Cubist • Currently serve on the speaker’s bureau for Astellas Pharma and Forest Labs This presentation does not promote any particular branded product

5. Objectives • Describe the origins of Antimicrobial Stewardship • Discuss the core and supplemental strategies for an effective Antimicrobial Stewardship Program • Recall the California Antimicrobial Stewardship Program Initiative • Discuss how the California Initiative can affect healthcare nationwide

6. “Drug resistance follows the drug like a faithful shadow.” - Paul Erhlich 1854-1915

7. “It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them, and the same thing has occasionally happened in the body…there is the danger that the ignorant man may easily under-dose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” -Alexander Fleming, Nobel prize lecture, 1945

8. Nature Reviews: Drug Discovery. 2007: 6; 8-12.

9. “Bad Bugs, No Drugs.” IDSA. July 2004

10. Bad Bugs, No Drugs In July 2004, IDSA sent a white paper to Capitol Hill stressing the rapidly growing public health crisis in the emergence of bacteria that were resistant to many, if not all, antibiotics that typically had activity against them “Bad Bugs, No Drugs.” IDSA. July 2004

11. Bad Bugs, No Drugs • IDSA expressed their concerns with the drying pipeline of new antibiotics • Resistant bacteria cause infection in the young and old, the healthy and frail • 2 million people acquire healthcare associated infections (HAI); 90,000 die annually • Higher healthcare costs - $5 billion annually • Big Pharma can’t turn a profit with antibiotics • 10 – 20 years and $800 million – $1.7 billion to bring a drug to market • National and global security problem • Dwindling drug discovery and increasing antibiotic resistance are increasing threats to the US public health “Bad Bugs, No Drugs.” IDSA. July 2004

12. “Bad Bugs, No Drugs.” IDSA. July 2004 “Bad Bugs, No Drugs.” IDSA. July 2004

14. Potential Legislative Solutions to Fuel Innovation • Commission to pass legislation to prioritize antimicrobial discovery targeting certain problematic pathogens • “Wild-card patent extensions” • Restoration of all patent time lost during FDA review • Extended market exclusivity • Tax incentives for R&D of priority antibiotics • Liability protection • Antitrust exemptions for certain company communications • A guaranteed market “Bad Bugs, No Drugs.” IDSA. July 2004

16. Guidelines to develop an institutional Antimicrobial Stewardship Program (ASP) • Antimicrobial Stewardship committee • Computer surveillance and decision support software • Proactive microbiology lab • Monitoring of process and outcomes measures • Elements of an ASP • Active Strategies • Supportive Strategies 2007 ASP Guidelines. CID. 159-177

17. Meanwhile, in California… California Senate Bill 739 (Health & Safety Code §§ 1288.5 to 1288.9 [2006])

18. What is SB 739? • By 1/1/2008, California Department of Public Health (CDPH) required that all general acute care hospitals • evaluate their antibiotic use • create an oversight committee to monitor responsibilities for this issue • CDPH responsible for implementing a program for the statewide surveillance and prevention of HAI in acute care California Senate Bill 739 (Health & Safety Code §§ 1288.5 to 1288.9 [2006])

20. How did they go about this? • Dec 2009 – HAI program staffed • Feb 2010 – Kavita Trivedi, MD hired by the CDPH to spearhead the California Antimicrobial Stewardship Program initiative (CASPI) • Public Health Medical Officer • Worked with over 100 different facilities throughout California Alliance for Prudent Use of Antibiotics (APUA). Volume 29, No. 1

21. Public Health Medical Officer • Collected ideas on best practices from facilities that had some sort of an ASP in place • Offered ideas to facilities on how to overcome barriers to implementation of an ASP, as well as best practices for implementation and performance metrics for effectiveness Alliance for Prudent Use of Antibiotics (APUA). Volume 29, No. 1

22. Did this legislation work? • Widespread interest from many Californian healthcare facilities • Survey of acute care facilities conducted from May 2010 to March 2011 to gather data on implementation of ASP’s throughout California Alliance for Prudent Use of Antibiotics (APUA). Volume 29, No. 1

23. Did this legislation work? • CASPI Survey 5/10 – 3/11 • 229 respondents of 383 acute care facilities • 48% had an ASP in place • 28% were planning one • 10% started an ASP due to SB 739 • Of the 177 self-identified community hospitals: • 45% had an ASP in place • 29% were planning one To date, California is the only state with this type of mandate!! Alliance for Prudent Use of Antibiotics (APUA). Volume 29, No. 1

24. Why does California matter? • In 2009, California was ranked the 8th largest economy in the WORLD!! • Estimated GSP (GDP) of $1.9 trillion • Any economic impact on California can have a ripple effect throughout the United States US Department of Commerce

25. Meanwhile, back at IDSA…

26. Public policy statements regarding prudent antibiotic use • Series of statements made by IDSA • Society for Healthcare Epidemiology of America (SHEA) and Pediatric Infectious Diseases Society (PIDS) also involved • Published in medical journals • Given by top-level members of IDSA to Congress pleading for legislation • discovery of new agents • curb the inappropriate use of existing agents • encourage appropriate infection control practices www.idsociety.org/Stewardship_Policy/

27. Presented on 6/9/10 by Brad Spelberg, MD, FIDSA to the House Committee on Energy and Commerce Subcommittee on Health www.idsociety.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=16656

28. IDSA’s multi-pronged approach to antibiotic resistance • fix the broken antibiotic drug pipeline • support the development and utilization of new rapid diagnostic tests • enact the Strategies to Address Antimicrobial Resistance (STAAR) Act (H.R. 2400) • implement effective infection prevention and control programs • support the development of new vaccines and appropriate immunization policies • stop non-judicious uses of antibiotics on U.S. farms (animal and plant agriculture) • view antibiotic resistance as a global health issue • promote the judicious use of antibiotics in human medicine (antimicrobial stewardship) IDSA Testimony on Antibiotic Resistance. www.idsociety.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=16656

29. Participating institutions • Community Hospital, Tallassee, AL • Centerpoint Medical Center, Independence, MO • Rogue Valley Medical Center, Medford, OR • St. Francis Medical Center, Peoria, IL • Seton Medical Center, Austin, TX • The Reading Hospital and Medical Center, West Reading, PA • Ronald Reagan UCLA Medical Center, Los Angeles, CA • WellStar Cobb Hospital, Austell, GA. CDC Get Smart for Healthcare. www.cdc.gov/getsmart/healthcare/learn-from-others/resources/index.html

30. Addressed successes and shortcomings of CASPI • Series of 5 recommendations • 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 Infect Control Hosp Epidemiol 2012;33(4):322-327

31. Addressed possibility of mandating ASP for participation in CMS reimbursement • Considered a “good idea” Federal Register. Vol 77; No. 95

32. Summary • Multi-drug resistant pathogens are becoming more common everywhere • New antibiotics with novel mechanisms of action are not being produced by Big Pharma • Antibiotic stewardship is meant to optimize the use of antibiotics, not to police them • California SB 739, CASPI can help kick-start national legislation of ASP as a requirement for participation in CMS reimbursement • We all need to do our part in the responsible prescribing of antibiotics; it effects all of us

33. "The last decade has seen the inexorable proliferation of a host of antibiotic resistant bacteria, or bad bugs, not just MRSA, but other insidious players as well. ...For these bacteria, the pipeline of new antibiotics is verging on empty. 'What do you do when you're faced with an infection, with a very sick patient, and you get a lab report back and every single drug is listed as resistant?' asked Dr. Fred Tenover of the Centers for Disease Control and Prevention (CDC). 'This is a major blooming public health crisis.'“ —Science magazine; July 18, 2008

34. Questions?

35. Agenda for Today’s Call • Review of agenda:  D. Quetti • DPH update: R. Melchreit, MD • “Long-term care assessment of AMS practices” GNYHA survey:  participation rates and final results:  D. Quetti • Status report on conferring process for NHSN rights and “group” formation:  D. Quetti • Status report on community progress to date (scope of work, participants, successes and barriers):  Community Leaders • Farmington • Manchester • Meriden • Middlesex • New Britain • Waterbury • Suggestions for future conference call topics:  All participants • Developing an elevator speech • Proposed date for collaborative wrap up session:  Thursday, July 25, 2013 • Proposed next monthly call:  Tuesday, April 23, 2013 at 12 noon