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National Antimicrobial Resistance Monitoring System (NARMS) Internal Review and Recommendations

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Title: National Antimicrobial Resistance Monitoring System (NARMS) Internal Review and Recommendations


1
National Antimicrobial Resistance Monitoring
System (NARMS)Internal Review and Recommendations
Submitted by the NARMS Internal Review Committee
to the FDA Science Board March 31, 2006
2
Background
  • In food animals, antimicrobials are used for the
    control, prevention and treatment of infectious
    bacterial diseases as well as for enhancing
    growth and feed efficiency purposes
  • An undesired consequence of this use is the
    potential development of antimicrobial resistant
    zoonotic bacterial pathogens and subsequent
    transmission to humans
  • Recognizing this potential health hazard, WHO,
    FAO and OIE recommend that countries implement
    monitoring programs aimed at determining the
    occurrence of antimicrobial resistance in
    bacteria from animals, foods and humans

3
NARMS
  • The National Antimicrobial Resistance Monitoring
    System (NARMS) is a national collaborative
    network between the FDA, CDC and USDA as well as
    public health laboratories in all 50 states and
    local health departments in three major cities
  • NARMS was developed to monitor changes in
    susceptibility/resistance of select zoonotic
    bacterial pathogens and commensal organisms
    recovered from animals, retail meats and humans
    to antimicrobial agents of human and veterinary
    importance
  • NARMS monitors susceptibility/resistance
    phenotypes using three testing sites including
  • FDA/CVM (retail meat and poultry)
  • CDC (humans)
  • USDA (animal/slaughter)

4
NARMS Goals
  • Generate descriptive data on the extent and
    temporal trends of antimicrobial
    susceptibility/resistance in enteric organisms
    from human and animal populations
  • Provide information to veterinarians, physicians,
    stakeholders and public health authorities on
    emerging, unusual or high levels of bacterial
    drug resistance so that timely action can be
    taken to protect public health

5
NARMS Goals
  • Design follow-up epidemiology and research
    studies to better understand the emergence and
    transfer of antimicrobial drug resistance
  • Prolong the lifespan of approved antimicrobials
    by promoting prudent use

6
NARMS Reviews
  • CDC NARMS review
  • August 12-13, 2003
  • Focused on only the CDC component
  • External review report is provided in Appendix I
  • NARMS expert review
  • June 23-24, 2005
  • Focused on all 3 NARMS components
  • FDA
  • USDA
  • CDC
  • Expert review results are provided in Appendix II

7
NARMS Internal Review Committee
  • Charged with conducting a self assessment and
    preparing recommendations for the FDA Science
    Boards review
  • FDA-CVM
  • FDA-CDER
  • FDA-OC
  • USDA
  • CDC
  • Identified four key areas for the FDA Science
    Board Review
  • Sampling
  • Epidemiological and microbiological research
  • Harmonization of data reporting
  • Coordination with international surveillance

8
NARMS Review
  • NARMS is a very strong program and is an
    important part of national public health
    surveillance in the United States
  • It has broad support from diverse sectors and
    numerous stakeholders
  • It has matured since its inception in 1996 and
    would benefit from the input of the FDA Science
    Board on its key elements and future directions

9
NARMS Information
  • NARMS internal review and recommendations
  • Contains background and information with regards
    to the four key areas we would like your input on
  • Sampling
  • Epidemiological and microbiological research
  • Harmonization of data reporting
  • Coordination with international surveillance
  • Structure of each section
  • Introduction
  • Description
  • CDC external review comments
  • NARMS (all arms) expert review comments
  • Strengths and limitations
  • Recommendations of the Internal Review Committee

10
NARMS Information
  • Five appendices
  • CDC external review of human arm
  • FDA-CVM expert review of all arms
  • NARMS internal review committee members
  • research references for work conducted by NARMS
  • Examples of tables and figures for NARMS
    integrated report
  • Relevant background materials
  • CAHFSE Collaboration for animal health, food
    safety, and epidemiology (USDA)
  • FoodNet (CDC)
  • Guidance 152 Evaluating the safety of
    antimicrobial new animal drugs with regard to
    their microbiological effects on bacteria of
    human health concern (FDA)
  • Presentations from NARMS expert review in June,
    2005

11
Questions for the FDA Science Board
  • Are there inherent biases in the sampling
    strategies employed in NARMS? If so, how can they
    be improved to ensure that the data and our
    interpretations are scientifically sound given
    current resources?

12
Questions for the FDA Science Board
  • Are there epidemiological and/or microbiological
    research studies that would better serve the
    goals of NARMS and the regulatory work of FDA?

13
Questions for the FDA Science Board
  • Are our current plans for data harmonization and
    reporting appropriate? If not, what alternative
    approaches would you consider and what should be
    the top priorities for harmonization and
    reporting?

14
Questions for the FDA Science Board
  • Are the current NARMS international activities
    adequate to maintain a significant collaboration
    with worldwide efforts to mitigate the spread of
    antimicrobial-resistant foodborne bacteria?

15
NARMS Internal Review Committee Members
  • Tom Chiller (FDA/CDC)
  • Susan Dewitt
  • Paula Fedorka-Cray (USDA)
  • Joshua Hayes
  • Elvira Hall-Robinson
  • Ibrahim Kamara
  • Beth Karp
  • Patrick McDermott
  • John Powers (FDA/CDER)
  • Jane Robens (USDA)
  • Gerald Rushin
  • Linda Tollefson (FDA/OC)
  • David White
  • Linda Youngman

We would also like to extend our thanks to
Marcella Pratt, John Marzilli, and CVM/CMT
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