The U.S. National Antimicrobial Resistance Monitoring System:

Transcription

The U.S. National Antimicrobial Resistance Monitoring System:
The U.S. National Antimicrobial
Resistance Monitoring System:
Achievements and Challenges
Patrick McDermott, Ph.D.
Director, NARMS
U.S. Food & Drug Administration
Center for Veterinary Medicine
Office of Research
Laurel, MD USA
The “Golden Age” of Antibiotics
Began in 1933, when an antibiotic called sulfanilamide
cured a 10-month old German infant dying of a
bloodstream staphylococcal infection.
Gerhard Domagk,
sulfa drug pioneer.
Nobel Prize, 1939
The “Golden Age” of Antibiotics
“For most of the infectious diseases on the
wards of Boston City Hospital in 1937, there
was nothing that could be done beyond bed rest
and good nursing care. Then came the
explosive news of sulfanilamide, and the start of
the real revolution in medicine. I remember the
astonishment when the first cases of
pneumococcal and streptococcal septicemia
were treated in Boston in 1937. The
phenomenon was almost beyond belief. Here
were moribund patients, who would surely have
died without treatment, improving…within a
matter of hours…and feeling entirely well within
the next day…we became convinced, overnight,
that nothing lay beyond reach for the future.”
Lewis Thomas. Notes of a Medicine Watcher. ‘83. Viking Press
•Albert Lasker Award
•Member of the NAS
•National Book Award
The “Golden Age” of Antibiotics
1952
Words of Caution
The Nobel Prize in Physiology
or Medicine 1945
"for the discovery of penicillin and its
curative effect in various infectious
diseases"
Sir Alexander Fleming
Sir Howard Florey
Ernst Chain
Sir Alexander Fleming
Nobel Lecture,
December 11, 1945
“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.”
Impact of Resistance
1. More expensive/toxic drugs
2. Additional diagnostic testing
3. Extended length of stay in the
hospital
4. Costs to patient/family-time
from work, increased mortality
5. Resistance genes remain a
problem for the future – the
hospital/farm as reservoir
Summary of International Activities
• TATFAR – created in 2009 to promote cooperation and info
exchange between US and EU on human and animal aspects of
AMR
• GHSA AMR action package – Surveillance, one health, and R&D
working groups
• WHO GAP 2015 requests the Member States to effectively address
the problem by strengthening their national systems
– Surveillance – GLASS
– PAHO – addressing AMR
• G7 - under the 2015 German Presidency suggested convening an
experts group – includes Japan
• G20 – China plans to make AMR a subject for their presidency in
2016
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The US National Action Plan
March 2015
Outlines steps for implementing the National Strategy on Combating AntibioticResistant Bacteria and addressing the policy recommendations of the
President’s Council of Advisors on Science and Technology (PCAST) report on
Combating Antibiotic Resistance. Five goals:
1. Slow the emergence of resistant bacteria and prevent the spread of
resistant infections.
2. Strengthen national one-health surveillance efforts to combat resistance.
3. Advance development and use of rapid and innovative diagnostic tests for
identification and characterization of resistant bacteria.
4. Accelerate basic and applied research and development for new
antibiotics, other therapeutics, and vaccines.
5. Improve international collaboration and capacities for antibiotic-resistance
prevention, surveillance, control, and antibiotic research and
development.
Includes information sharing, surveillance (drug use and resistance), stewardship
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initiatives, risk assessments, and more.
Level of concern depends on pathogen and type of resistance
Urgent Threats
Clostridium difficile
Carbapenem-resistant Enterobacteriaceae (CRE)
Drug-resistant Neisseria gonorrhoeae
Serious Threats
Multidrug-resistant Acinetobacter
Fluconazole-resistant Candida (a fungus)
Vancomycin-resistant Enterococcus (VRE)
Multidrug-resistant Pseudomonas aeruginosa
Drug-resistant Salmonella Typhi
Drug-resistant Shigella
Methicillin-resistant S. aureus
Drug-resistant Streptococcus pneumoniae
Drug-resistant tuberculosis
Drug-resistant Campylobacter
Drug-resistant Non-typhoidal Salmonella
ESBL+ Enterobacteriaceae
Concerning Threats
Vancomycin-resistant S. aureus (VRSA)
Erythromycin-resistant Group A Streptococcus
Clindamycin-resistant Group B Streptococcus
FDA Center for Veterinary Medicine
Strategy to Limit Resistance
Multipronged strategy designed to limit or reverse resistance
arising from the use of antibiotics in food-producing animals, while
continuing to ensure the availability of safe and effective antibiotics
for use in animals and humans
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The National Antimicrobial Resistance Monitoring System
Extralabel use prohibition of fluoroquinolones and glycopeptides
Revised safety assessment process (GFI #152)
Withdrawal enrofloxacin in poultry
Revised judicious use guidance (GFI #209)
Cephalosporin extralabel use prohibition
Industry guidance on eliminating production uses (GFI #213)
Enhanced annual summary of antibiotic sales data
Update on veterinary feed directive (GFI #120)
Collaboration with international partners (WHO, OIE, Codex)
1996
1997
2003
2005
2012
2012
2013
2014
2015
What is integrated surveillance of
antimicrobial resistance in
foodborne bacteria?
The coordinated sampling and testing of bacteria from
food animals, foods, and clinically ill humans; and the
subsequent evaluation of antimicrobial resistance trends
throughout the food production and supply chain using
harmonized methods.
Source: WHO-AGISAR report
Purpose of Integrated Surveillance
1. Baselines - Document resistance levels in different reservoirs
2. Spread - Describe the spread of resistant bacterial strains and resistance genes
3. Trends - Identify temporal and spatial trends in resistance
4. Attribution - Generate hypotheses about sources and reservoirs of resistant bacteria
5. Risk analysis - Understand links between use practices and resistance
6. BOI - Identify risk factors and clinical outcomes of infections caused by AMR bacteria
7. Education - Provide data for education on current and emerging hazards
8. Policy - Guide evidence-based policies and guidelines to control antimicrobial use in
hospitals, communities, agriculture, aquaculture, and veterinary medicine
9. Regulations
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Pre-harvest - Support risk analysis of foodborne antimicrobial resistance hazards
Post-harvest - Identify interventions to contain resistance and evaluate their effectiveness
10. Evaluate interventions 12
11. Go back to #1
Challenges of Integrated Surveillance
for Antimicrobial Resistance
1. Gathering accurate information and bacterial isolates is expensive
and laborious
2. Burden of illness and food consumption data are needed for design
and prioritization of pathogens and commodities
3. Sound sampling scheme along the food chain is critical for valid
trend analysis
4. Combining resistance and use data in a meaningful way
5. Cooperation, collaboration, good communication and data sharing
between
a. agriculture, industry and public health sectors
b. microbiologists & epidemiologists within and across sectors
Challenges of Integrated Surveillance
for Antimicrobial Resistance
6. Political/financial support - Requires recognition of the public health
issues and the need for ongoing risk assessments
7. Establish a process for review and enhancement
8. Remain flexible in order to stay current
9. Adapt to changing technologies
10. Understanding the implications of the data and the need for research
11. Publishing often very complex findings to different audiences in a
timely manner
12. Using the data to formulate sound public health policy
13. International harmonization and cooperation
Bacteria Tested
Human - CDC
Animal - USDA
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Non-Typhoidal Salmonella
(1996)
Campylobacter (1997)
E. coli 0157:H7 (1996)
Salmonella Typhi (1999)
Shigella (1999)
Vibrio
Enterococcus (2001)
E. coli (2004)
Non-Typhoidal Salmonella (1997)
Campylobacter (1998)
E. coli (2000)
Enterococcus (2003)
Retail Meats - FDA (2002)
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Non-Typhoidal Salmonella
Campylobacter
Enterococcus
E. coli
NARMS Objectives
1.
Monitor trends in antimicrobial resistance among
foodborne bacteria from humans, retail meats, and
animals
2.
Disseminate timely information on antimicrobial
resistance to promote interventions that reduce
resistance among foodborne bacteria
Conduct research to better understand the emergence,
persistence, and spread of antimicrobial resistance
3.
4.
Assist the FDA in making decisions related to the
approval of safe and effective antimicrobial drugs for
animals
NARMS Strategic Plan
Goal 1: To develop, implement and
optimize a shared database, with
advanced data acquisition and
reporting tools
Goal 2: To make sampling more
representative and more applicable
to trend analysis
Goal 3: To strengthen collaborative
research projects to address high
risk food safety issues
2012-2016
Goal 4: To support international
activities which promote food safety,
and mitigate the spread of
antimicrobial resistance
1.
Monitor Trends: Sampling
Strategy
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Human isolated testing - CDC
• Bacteria isolated at the state laboratory and sent to CDC for
susceptibility testing and additional analyses
• Non-typhoidal Salmonella- all 50 states submit every 20th isolate
• Campylobacter- 10 FoodNet sites submit every 2nd, 3rd, or 5th
isolate
• More details at www.cdc.gov/narms
Retail meat testing - FDA
• 14 sites total since 2013
• 2002- mid 2015 each site collected 40 meats/month (10 each of chicken
parts, ground turkey, pork chop, and ground beef)
• Beginning mid 2015 each site collects 80 meats/month (40 chicken parts, 20
ground turkey, 10 pork chop, and 10 ground beef)
• All sites culture for Salmonella (all meat types) and Campylobacter (poultry)
• Four sites culture for E. coli and Enterococcus
• Isolates are sent to FDA for analysis
• Sample total = 6,720 per annum
13,440
History of NARMS - USDA
Old System (HACCP)
1. In Plant
Pathogen
Western Lab
FSIS PR/HACCP
samples
Midwestern Lab
ARS Eastern
Lab received
Salmonella
isolates
Eastern Lab
Chicken carcasses
Campylobacter,
E coli,
Enterococcus
Swine
Cattle
Campylobacter
Salmonella
Chicken
Turkeys
x
x
x
x
E. coli
x
Enterococcus
x
x
New System (Cecal)
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Samples taken by FSIS veterinarians and
inspectors at FSIS-regulated plants and
establishments
Cecal samples better reflect animal status and
less confounded by plant events
A randomized, nationally representative
testing of slaughterhouses
Ability to distinguish production classes
Complete microbiology for all animal species
Swine
hogs,
sows
Cattle
dairy,
beef
steers,
heifers
Chicken
Turkeys
Campylobacter
x
x
x
x
Salmonella
x
x
x
x
E. coli
x
x
x
x
Enterococcus
x
x
x
x
Pathogen
History of NARMS – USDA
2. On-Farm
• Collaboration with USDA- Agricultural Research Service
(ARS) and University partners
• Examining resistance on farm and differences between
farm and slaughter
• Looking for rare phenotypes (early detection)
• Interventions
• Drug use information
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NARMS Highlights 2013
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About 80% of human Salmonella
isolates are not resistant to any of the
tested antibiotics, a finding that has not
changed in the past 10 years.
Further, resistance to ceftriaxone,
azithromycin, and quinolones, three
important drugs used to treat human
Salmonella isolates, remains below 3%.
Salmonella multi-drug resistance
(resistance to three or more classes of
antibiotics) in human, cattle, and chicken
isolates has not changed or declined in
the last decade,
CipR C. jejuni resistance was at its
lowest level in retail chicken to date
(11%).
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NARMS Highlights 2013
Multidrug resistance (MDR)
in human isolates of a
common Salmonella
serotype (l 4,[5],12:i:-)
continues to rise.
Resistance has more than
doubled from 18% in 2011
to 46% in 2013.
An increase in MDR and
ceftriaxone resistance was
also observed in Salmonella
serotype Dublin isolated
from cattle and human
sources.
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Resistance in Salmonella from
Humans: 1948-1990s
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Resistance in Salmonella from
Humans: 1996-2011
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Resistance in Salmonella from Humans:
1948-2011
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1.
Monitor Trends: Laboratory
Methods
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Antimicrobial Susceptibility Testing
NCCLS Quality Control Organisms (ug/ml)
Antimicrobial
cefoxitin
azithromycin
chloramphenicol
tetracycline
ceftriaxone
amoxicillin/clavulanate
ciprofloxacin
gentamicin
nalidixic acid
ceftiofur
sulfamethoxazole
trimethoprim/sulfa
kanamycin
ampicillin
streptomycin
positive control
negative control
Total # wells
Resistant
NARMS
#wells Ranges
breakpoint
/plate
S. aureus
E. faecalis
E. coli
P. aeruginosa
Within
ug/ml
29213
29212
25922
27853
CLSI QC
1-4
0.25-2
2-8
0.12-1
1-8
0.12-0.5
0.12-0.5
0.12-1
>=32
>=16
>=32
>=16
>=4
>=32/16
>=4
>=16
>=32
>=8
>=512
>=4/76
>=64
>=32
7
8
5
4
8
6
9
7
7
7
6
6
4
6
0.5-32
0.125-16
2-32
4-32
0.5-64
1-32
0.015-4
0.25-16
0.5-32
0.12-8
16-512
0.12-4
8-64
1-32
none
2
3
1
96
32-64
0.25-1
32-128
<0.5/9.5
1-4
0.25-1
64-256
4-16
8-32
0.25-1
0.25-2
4-16
32-128
<0.5/9.5
16-64
0.5-2
1-4
0.5-4
2-8
0.5-2
0.03-0.12
2/1-8/4
0.004-0.015
0.25-1
1-4
0.25-1
8-32
<0.5/9.5
1-4
2-8
1-4
8-32
8-64
0.25-1
0.5-2
16-64
8/152-32/608
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
None
in CLSI QC range
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Drug selection
• Important in veterinary medicine (e.g. tetracycline)
• Important in human medicine (e.g. carbapenems)
• Important in both human and veterinary medicine
(e.g. cephalosporins, fluoroquinolones)
• Epidemiologic markers (e.g. chloramphenicol)
• Harmonized with CIPARS
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Added Value of NARMS
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Understanding the sources of resistance also helps with strain attribution in
BOI estimates
Outbreak detection – PulseNet (NARMS PulseNet database has >12,000 data
entries)
• 8,380 Salmonella
• 3,439 Campylobacter
• 547 E. coli
• 69 Vibrio
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Phylogenetics
Evolution of MDR
Virulence
Trend analysis
Method development
Emerging trends
Networked of trained and dedicated laboratory personnel and epidemiologists
Infrastructure for targeted studies
Opportunity to serve broader FDA food safety priorities
Additional Analyses
Source: CDC
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2.
Reporting: Disseminate timely
information
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Human Population
Retail Meats
Physician Visit
Random stratified sampling
in 14 States
ORA Imported Foods
Local Lab
State Lab
Grocery Stores
Chicken
Ground turkey
Ground beef
Pork chop
Farm Pilots
Farm to Slaughter
Drug use data point
Animals
Random sampling
of national
production
at slaughter
Chickens, Turkeys,
Cattle, Swine
HACCP
2013-present
HACCP
1997-2013
Chicken
only
Other pathogens surveyed
Campylobacter
Salmonella
Enterococcus
E. coli
Data Integration
Integrated
Report
Integrated NARMS Report
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Integrated NARMS Report cont’d
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Integrated NARMS Report cont’d
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Antimicrobial Drugs Approved for Use in Food-Producing Animals:
2011 Sales and Distribution Data Reported by Drug Class
Domestic
Export
Antimicrobial Class
Aminoglycosides
Annual Totals (kg)
214895
Cephalosporins
Ionophores
26,611
4,123,259
Lincosamides
Macrolides
190,101
582,836
Penicillins
880,163
Sulfas
371,020
Tetracyclines
5,642,573
NIR
1,510,572
Tetracyclines
15,321
NIRE
185,333
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Conduct Research
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Added Value of Integrated
Surveillance
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Source attribution is useful in burden of
illness estimates
Database of strain relatedness for
outbreak detection
Phylogenetics
Evolution of MDR
Virulence
Method development
Emerging trends
Networked of trained and dedicated
laboratory personnel and epidemiologists
Infrastructure for targeted studies
Opportunity to serve broader food safety
priorities
Welch TJ, Fricke WF, McDermott PF, et al. Multiple
antimicrobial resistance in plague:an emerging public
health risk. PLoS One. 2007 Mar 21;2(3):e309.
NARMS Research: Filling the Gaps
in Surveillance
1. Standardize and validate in vitro antimicrobial susceptibility
testing methods
2. Measure the effects of veterinary antimicrobials on emergence
of resistance in zoonotic foodborne bacteria in target animals
3. Examine the role of animal feeds (rendered products, dried
commodities, complete feeds) in the ecology of resistance
4. Risk factors and clinical outcomes infections caused by AR
pathogens
5. Characterize and compare molecular mechanisms of resistance
6. Develop rapid methods to identify/characterize resistant bacteria
(WGS)
Assist the FDA
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Qualitative Risk Assessment:
Components and Procedures
Hazard Characterization
Qualitative Risk Assessment
Release
Assessment
probability that resistant bacteria are present in
target animal as a consequence of drug use
(rank as High, Medium, or Low )
Exposure
Assessment
probability for humans to ingest bacteria in question
from the relevant food commodity
(rank as High, Medium, or Low )
Consequence
Assessment
probability that human exposure to resistant
bacteria results in an adverse health consequence
(rank as High, Medium, or Low )
Overall Risk Estimate: Integration of
release, exposure and consequence
assessments.
(rank as High, Medium, or Low )
Risk Estimation
Where can we use NARMS Data?
• Release Assessment
– Parameters:
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Mechanism of Activity – Class of Drug, targeted action
Spectrum of Activity – Gram +/- activity, susceptibility data
Resistance mechanisms – Structural, efflux, gene
Resistance Transfer – chromosomal, mobile element
Selection Pressure – co-selection
• Exposure Assessment
– Parameters:
• Consumption of commodity
• Prevalence of zoonotic pathogens in commodity
• Prevalence of resistance in zoonotic pathogens
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Consequence Assessment
Describes human health consequence of exposure to resistant
bacteria based on importance of drug (or related drugs) to
humans (ranking of antimicrobials)
Drug Ranking Examples
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Critically Important
3rd Generation cephalosporins (Ceftriaxone), macrolides (Erythromycin),
fluoroquinolones (Ciprofloxacin).
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Highly Important
4th Generation cephalosporins, aminoglycosides, clindamycin
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Important
1st & 2nd Generation cephalosporins, monobactams, quinolones
Examples of Risk Management Tools
Approval
conditions
Category 1 (H)
Category 2 (M)
Category 3 (L)
Marketing
status
Rx
Rx/VFD
Rx/VFD/OTC
Extra-label use
ELU restriction
Restricted in
some cases
ELU permitted
Extent of use
Low
Low/Medium
Low, Medium,
High
Advisory
committee
review
YES
In certain cases
NO
Post-approval
monitoring
NARMS
NARMS
NARMS
GFI #152, Table 8, pp. 25
Withdrawal of Approval of
Fluoroquinolones for Poultry
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In 2000, CVM proposed the withdrawal of the
approval of the new animal drug applications
for fluoroquinolone use in poultry.
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Abbott Laboratories withdrew their
application for sarafloxacin.
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Bayer Corp. requested a hearing to address
the safety of Baytril™, the trade name for
enrofloxacin.
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CVM research validated a standardized AST
method for Campylobacter to evaluate the
resistance data being reported
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CVM research conducted in vivo treatment
studies with Campylobacter infected broilers
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The Final Decision of the FDA Commissioner
to withdraw the approval became effective
September 12, 2005.
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Extra-Label Use Prohibition of Certain
Cephalosporins
• Effective April 5, 2012
• FDA prohibits unapproved uses
of 3rd gen. cephalosporins in
cattle, swine, chickens and
turkeys. The prohibited uses
include:
–using cephalosporin drugs at
unapproved dose levels, frequencies,
durations, or routes of administration;
–using cephalosporin drugs in cattle,
swine, chickens or turkeys that are not
approved for use in that species (e.g.,
cephalosporin drugs intended for
humans or companion animals);
–using cephalosporin drugs for disease
prevention.
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Impact of GFI #209
• Removes production claims for medically important
antimicrobials used in food-producing animals
• Places other feed and water drugs under veterinary
control
• Begins in January 2017
• Sensitivity of NARMS to measure impact will be tested
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The future of integrated
antimicrobial resistance
monitoring
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Surveillance Today
Humans
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Isolate pure cultures from samples
obtained from animals, foods & people
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Ship them to central laboratories to
conduct a small number of expensive
and labor intensive assays in batch using
specialized reagents
1
2
3
4
5
6
7
8
9
10
11
12
13
Typhimurium
Enteritidis
Newport
Heidelberg
I 4,[5],12:i:Javiana
Muenchen
Montevideo
Tennessee
Mississippi
Oranienburg
Braenderup
Agona
Chicken Breast
Typhimurium
Kentucky
Heidelberg
Enteritidis
Montevideo
I 4,[5],12:i:Hadar
Mbandaka
Oranienburg
Other
Ground Turkey
Hadar
Heidelberg
Saintpaul
Reading
Schwarzengrund
Senfternberg
Agona
Minnesota
Albany
I 4,5,12:r:Muenchen
Other
Cattle
Montevideo
Dublin
Muenster
Newport
Mbandaka
Typhimurium
Cerro
Anatum
Agona
Meleagridis
Infantis
Other
Swine
Typhimurium
Derby
Johannesburg
Infantis
Anatum
Saintpaul
Adelaide
London
Hadar
Agona
Muenchen
Other
– AST, PFGE, Serotyping
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Present aggregated phenotype data over
time in an integrated fashion
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Perform research projects to more fully
characterize and compare strains, and
publish the results months-years later.
– Phage typing, plasmid typing, MLST,
CRISPR, virulence typing, R-gene
sequencing, etc.
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Surveillance tomorrow
Next generation sequencing technology is changing the science of infectious
disease. It has the potential to serve as the single assay of NARMS surveillance
in the future and to supplant multiple methods, saving time and money.
1.
2.
3.
4.
Classical serotyping
PFGE and other strain typing methods
In vivo antimicrobial susceptibility testing
Piecemeal PCR gene detection and plasmid typing
And to provide:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Genome/nucleotide surveillance
Virulence profiles
Molecular phage typing
Markers for source attribution
Better understanding of emerging trends
Costs savings - $20 - $60 per isolates
Resistance to drugs not tested
Integration with drug use information
Metagenomic surveillance and CIDT
34/P
aph(2’)-Ig
tetO
aad9*
aadE sat4
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Surveillance tomorrow
• Separate microbial surveillance systems based on and
limited by methodology (PulseNet, NARMS, HACCP, NSS,
hospital programs) will eventually contribute to and share a
common, mobile, database.
• New opportunities for additional sample sources as costs
continue to drop ($20-60/isolate) resulting in better trend
analysis and greater sensitivity to changing patterns.
• Ability to address resistance in other ecosystems involving
zoonotic and environmental spread
– Companion animals, other (minor) food animal sources,
imported products, environmental, produce, etc.
• Other pathogens and bacteria
• Real time data collection and analysis
• Better informed and more rapid public health response
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NARMS Objectives with WGS
1.
Monitor trends in antimicrobial
resistance among foodborne
bacteria from humans, retail
meats, and animals
2.
Disseminate timely information
on antimicrobial resistance to
promote interventions that
reduce resistance among
foodborne bacteria
Conduct research to better
understand the emergence,
persistence, and spread of
antimicrobial resistance
3.
4.
1.
Monitor genomes in
antimicrobial resistant foodborne
bacteria from humans, retail
meats, food animals, companion
animals, feral animals and the
environment.
2.
Disseminate timely information
on changes in the resistome to
promote interventions that
reduce resistance among
foodborne bacteria and to
prevent emerging resistances
from becoming widespread
3.
Assist the FDA in making
decisions related to the approval
of safe and effective
antimicrobial drugs for animals
4.
Conduct in vivo research to
better understand the
emergence, persistence, and
spread of antimicrobial
resistance under different
conditions
Assist the FDA in making
decisions related to the approval
of safe and effective
antimicrobial drugs for animals
Strengths of NARMS
•
Comprehensive susceptibility data for managing risks associated with food animal
antibiotic use, including pre-approval review of new animal antibiotics and post-approval
safety monitoring of adverse events
•
Most extensive program of its kind in the word, suitable to the large US food productions
systems
•
Excellent example of federal collaboration and federal-state partnership
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CDC-FoodNet, CDC-PulseNet, USDA-FSIS, USDA-ARS, USDA-APHIS, FDA-ORA,FDA-CFSAN,
NIH, Universities, Industry.
Is a recognized model for international capacity building and technical standards
Robust and targeted research programs
Well characterized isolates are a rich source of information on FBP
Infrastructure in place for ad hoc food hazard analyses
Exceptional staff of well-trained and dedicated microbiologists, epidemiologists,
veterinarians, database managers, molecular biologists, bioinformaticians, statisticians.
NARMS assists FDA in decision making on approving safe and effective antimicrobial
drugs, and supports the Agency’s mission as a science-based regulatory agency
Challenges
•
•
Detailed drug use information in
food producing animals
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Additional retail food isolates for
better trend analysis
•
Examining other pathogens and
commodities as needed without
compromising core functions.
Continued progress on linking
databases on food safety
•
Exploiting other sources of data on
AR (e.g., hospitals and clinics)
•
Professional development and
training on emerging technologies
•
Collecting and incorporating import
data into NARMS as needed
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Resources for research
•
IT and computing infrastructure for
WGS
•
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Communication of complex data
sets in a clear way to different
audiences
Future Needs
Providing timelier data generation,
analysis and reporting
Acknowledgements
USDA-ARS
FDA/CVM
CDC
Eileen Thacker
Paula Fedorka-Cray
Jovita Haro
Jason Abbott
Sherry Ayers
Sonya Bodeis-Jones
Emily Crarey
Sharon Friedman
Stuart Gaines
Michael Grabenstein
David Heller
Claudine Kabera
Claudia Lam
Melissa Warren
Crystal Rice-Trujillo
Jonathan Sabo
Heather Tate
Thu Thuy-Tran
Shenia Young
Shaohua Zhao
Cindy Friedman
Jean Whichard
Beth Karp
Jason Folster
Allison O’Donnell
Jared Reynolds
Julian Grass
Felicita Medalla
USDA-APHIS
Dave Dargatz
Bruce Wagner
USDA-FSIS
Uday Dessai
Emilio Esteban
Alice Thayer
Bill Cray
Jodie Plumblee
FDA/CFSAN
Eric Brown
Mark Allard
Ruth Timme
Errol Strain
Mary Torrence
Non-federal partners
Public health and veterinary
diagnostic laboratories
FoodNet EIP funded sites
Thank you
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