Antimicrobial Stewardship CollaborativeMonthly Conference Call

March 19, 201312:00pm – 1:00pm

Deb Quetti, RN MBA, BSN, CPHQProject Manager, Qualidigm

WELCOME

Agenda for Today’s CallWelcome and review of agenda:  D. QuettiPowerpoint 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. QuettiStatus report on conferring process for NHSN rights and “group” formation:  D. QuettiStatus 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, 2013Proposed next monthly call:  Tuesday, April 23, 2013 at 12 noon

Legislative Updates in Antimicrobial Stewardship

Mike Rinaldi, PharmDInfectious Diseases Pharmacist

Waterbury Hospital

DisclosuresServed on scientific Advisory Boards for Pfizer and CubistCurrently serve on the speaker’s bureau for Astellas Pharma and Forest Labs

This presentation does not promote any particular branded product

ObjectivesDescribe the origins of Antimicrobial StewardshipDiscuss the core and supplemental strategies for an effective Antimicrobial Stewardship ProgramRecall the California Antimicrobial Stewardship Program InitiativeDiscuss how the California Initiative can affect healthcare nationwide

“Drug resistance follows the drug like a faithful shadow.”

- Paul Erhlich 1854-1915

“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

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

“Bad Bugs, No Drugs.” IDSA. July 2004

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

Bad Bugs, No DrugsIDSA 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

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

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 reviewExtended market exclusivityTax incentives for R&D of priority antibioticsLiability protectionAntitrust exemptions for certain company communicationsA guaranteed market

“Bad Bugs, No Drugs.” IDSA. July 2004

Guidelines to develop an institutional Antimicrobial Stewardship Program (ASP)

Antimicrobial Stewardship committeeComputer surveillance and decision support softwareProactive microbiology labMonitoring of process and outcomes measuresElements of an ASP– Active Strategies– Supportive Strategies

2007 ASP Guidelines. CID. 159-177

Meanwhile, in California…

California Senate Bill 739 (Health & Safety Code §§ 1288.5 to 1288.9 [2006])

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 issueCDPH 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])

How did they go about this?

Dec 2009 – HAI program staffedFeb 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

Public Health Medical Officer

Collected ideas on best practices from facilities that had some sort of an ASP in placeOffered 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

Did this legislation work?

Widespread interest from many Californian healthcare facilitiesSurvey 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

Did this legislation work?

CASPI Survey 5/10 – 3/11– 229 respondents of 383 acute care facilities

48% had an ASP in place28% were planning one10% started an ASP due to SB 739Of 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

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

Meanwhile, back at IDSA…

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 agentscurb the inappropriate use of existing agents encourage appropriate infection control practices

www.idsociety.org/Stewardship_Policy/

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

IDSA’s multi-pronged approach to antibiotic resistance

fix the broken antibiotic drug pipelinesupport the development and utilization of new rapid diagnostic testsenact the Strategies to Address Antimicrobial Resistance (STAAR) Act (H.R. 2400)implement effective infection prevention and control programssupport the development of new vaccines and appropriate immunization policiesstop non-judicious uses of antibiotics on U.S. farms (animal and plant agriculture)view antibiotic resistance as a global health issuepromote 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

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

Addressed successes and shortcomings of CASPISeries of 5 recommendations1. Antimicrobial Stewardship Programs Should Be Required through

Regulatory Mechanisms2. Antimicrobial Stewardship Should Be Monitored in Ambulatory Healthcare

Settings3. Education about Antimicrobial Resistance and Antimicrobial Stewardship

Must Be Accomplished4. Antimicrobial Use Data Should Be Collected and Readily Available for Both

Inpatient and Outpatient Settings5. Research on Antimicrobial Stewardship Is Needed

Infect Control Hosp Epidemiol 2012;33(4):322-327

Addressed possibility of mandating ASP for participation in CMS reimbursementConsidered a “good idea”

Federal Register. Vol 77; No. 95

SummaryMulti-drug resistant pathogens are becoming more common everywhereNew antibiotics with novel mechanisms of action are not being produced by Big PharmaAntibiotic stewardship is meant to optimize the use of antibiotics, not to police themCalifornia SB 739, CASPI can help kick-start national legislation of ASP as a requirement for participation in CMS reimbursementWe all need to do our part in the responsible prescribing of antibiotics; it effects all of us

"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

Questions?

Agenda for Today’s CallReview of agenda:  D. QuettiDPH update: R. Melchreit, MD“Long-term care assessment of AMS practices” GNYHA survey:  participation rates and final results:  D. QuettiStatus report on conferring process for NHSN rights and “group” formation:  D. QuettiStatus 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, 2013Proposed next monthly call:  Tuesday, April 23, 2013 at 12 noon