Post on 15-Jan-2016
Antimicrobial Stewardship Collaborative
Monthly Conference Call
March 19, 2013
12:00pm – 1:00pm
Deb Quetti, RN MBA, BSN, CPHQ
Project Manager, Qualidigm
WELCOME
Agenda for Today’s CallWelcome 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
Legislative Updates in Antimicrobial Stewardship
Mike Rinaldi, PharmD
Infectious Diseases Pharmacist
Waterbury Hospital
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
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
“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 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
“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 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])
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
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
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
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
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 agents
curb 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 CASPI
Series of 5 recommendations1. Antimicrobial Stewardship Programs Should Be Required through
Regulatory Mechanisms
2. Antimicrobial Stewardship Should Be Monitored in Ambulatory Healthcare Settings
3. Education about Antimicrobial Resistance and Antimicrobial Stewardship Must Be Accomplished
4. Antimicrobial Use Data Should Be Collected and Readily Available for Both Inpatient and Outpatient Settings
5. Research on Antimicrobial Stewardship Is NeededInfect Control Hosp Epidemiol 2012;33(4):322-327
Addressed possibility of mandating ASP for participation in CMS reimbursement
Considered a “good idea”
Federal Register. Vol 77; No. 95
SummaryMulti-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
"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. 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