Antimicrobial Stewardship Collaborative
Monthly Conference Call
March 19, 2013
12:00pm – 1:00pm
Deb Quetti, RN MBA, BSN, CPHQ
Project Manager, Qualidigm
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
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
“Bad Bugs,
Bugs, No
No Drugs.”
Drugs.” IDSA.
IDSA. July
July 2004
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
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
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
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 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
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 recommendations
1. 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 Needed
Infect 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
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
"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 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