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The Focus Areas: I. Surveillance

Surveillance of AR is critical to providing early warning of emerging problems, monitoring changing patterns of resistance, and targeting and evaluating prevention and control measures (e). Timely surveillance information is also necessary for assisting researchers in developing new drugs and for providing good patient care. For example, clinicians should be informed of drug resistance problems in their communities that may influence their prescribing decisions in order to help them avoid treatment failures. In addition, monitoring patterns of antimicrobial drug use is needed to interpret trends and variations in rates of AR, improve understanding of the relationship between drug use and resistance, identify and anticipate gaps in availability of existing drugs, and help identify preventive interventions.

At present, the United States lacks a coordinated national plan for AR surveillance. Creating a national plan requires collaboration with partners in the public and private sectors. Improved AR surveillance depends on enhancing epidemiologic and laboratory capabilities at local, state, and national levels; using standardized and reliable laboratory testing methods; and enhancing use of informatics.

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A. Issue: The United States lacks a coordinated national plan for surveillance of:

  • AR emergence in organism-drug combinations of public health importance and
  • Antimicrobial drug use in human and nonhuman settings.

     

1. Goal: Collaborate with appropriate partners to develop procedures and methods for surveillance of AR emergence in organism-drug combinations of public health importance.

a. Action Items

    1. Determine which organisms and susceptibility to specific antimicrobial drugs should be under surveillance and create a mechanism for periodic updating of this list.

         Coordinators: CDC, FDA, USDA, EPA
         Timeline: Initiated

    2. TOP PRIORITY ACTION ITEM - With partners, design and implement a national AR surveillance plan:
      • Identify the components of a national AR surveillance plan and the roles of
        partners in its design and implementation.
        Coordinator: CDC; Collaborators: DoD, DVA, FDA, USDA, HCFA
      • Determine which surveillance activities should be conducted routinely at
        national, regional, state, or local levels and which may require specialized
        projects.
        Coordinators: CDC, FDA, USDA
      • Define the roles of clinical, reference, public health, and veterinary laboratories
        at federal, state, and local levels in AR surveillance.
        Coordinator: CDC; Collaborators: DoD, DVA, FDA, USDA, HCFA
      • Improve coordination of AR surveillance systems at CDC, FDA, and USDA
        (e.g., identify components for integration).
        Coordinators: CDC, FDA, USDA
      • Consider the role of nongovernment funded surveillance and other data
        collection systems to augment a national surveillance plan.
        Coordinators: CDC, FDA, USDA
      • Ensure that the national AR surveillance plan is consistent with local and national surveillance methodology and infrastructure that currently exist or are being developed.
        Coordinators: CDC, USDA, FDA
      • Identify and assess practical surveillance strategies for components of the
        national plan by conducting pilot studies and demonstration projects.
        Coordinators: CDC, USDA, FDA
        Timeline for entire action item 2: Begin within one to two years
    3. Develop standards and methodologies.
      • Develop standards and methodologies for monitoring drug-resistant microbes in humans, animals, and plants as well as for monitoring drug-resistant microbes in food products and environmental samples.
        Coordinators: CDC, UDSA, FDA, EPA
      • Develop standardized laboratory methodologies and data elements that allow susceptibility test results and AR surveillance data to be compared across geographic jurisdictions.
        Coordinators: CDC, USDA, FDA, EPA
      • Explore the use of standardized definitions and methodology (Related Action Item: Surveillance #5) to create an electronic surveillance system healthcare institutions can use to compare AR data from other local facilities. Coordinator: CDC; Collaborators: HCFA, DVA, DoD, HRSA
      • Encourage development of local, regional, and national data systems that allow linking of microbiology, clinical and pharmaceutical data that would support local decision making for prevention and control of antimicrobial resistance and facilitate surveillance for antimicrobial resistance at all levels.
        Coordinator: CDC; Collaborators: HCFA, DVA, DoD, HRSA
      • Develop standards for reporting quantitative resistance data (e.g., minimal inhibitory concentrations or zone diameters) in ways that will detect decreased susceptibility. These standards are necessary because numerical AR test results reported nonquantitatively (e.g., as susceptible, intermediate, or resistant) as “susceptible” may mask an emerging AR problem, i.e, microbes with a small decrease in susceptibility may still be classified as susceptible.
        Coordinators: CDC, USDA, FDA
      • Assess how current policies on maintaining the confidentiality of medical and veterinary data collected for other purposes relate to procedures for gathering data on antimicrobial resistance. If necessary, develop a comprehensive national confidentiality policy on human and agricultural AR surveillance that includes both patient and institutional confidentiality, is consistent with confidentiality policies applied to other forms of surveillance and research data, and recognizes the differences in human and animal medicine and food production surveillance programs.
        Coordinator: CDC; Collaborators: DVA, HCFA, DoD, FDA, USDA
        Timeline for entire action item 3: Initiated
    4. Address additional surveillance issues unique to AR.
      • Conduct post-marketing surveillance for the development of resistance to critical antimicrobial drugs. Surveillance should be linked to information on drug use, and criteria should be developed to allow a prompt response to a finding of increased resistance associated with a specific pattern of use (e.g., consumer and professional alerts, enhanced education, labeling changes, or restrictions on use depending on the extent of and reasons for emergence of resistance). Coordinators: FDA, CDC, USDA
      • Facilitate the collection of AR surveillance data on pathogens for which cultures are not routinely obtained, either because the infections are empirically treated without laboratory diagnosis or because they are diagnosed with nonculture tests.
        Coordinator: CDC
      • Enhance availability of isolates of drug-resistant microbes to researchers (e.g., via a network of collections with an accessible databank).
        Coordinator: CDC; Collaborator: NIH Timeline for entire action item 4: Begin within one to two years

2. Goal: Collaborate with appropriate partners to develop procedures and methods for nationwide surveillance of antimicrobial drug use in human and nonhuman settings.

a. Action Items

  1. TOP PRIORITY ACTION ITEM - Develop and implement procedures for monitoring antimicrobial use in human medicine, agriculture, veterinary medicine, and consumer products:
    • Link human drug-use data to clinical information (e.g., diagnosis, severity of illness, and outcome).
    • Link agricultural drug-use data to species and usage patterns.
    • Assess potential effects of geographic variations in drug use on the incidence and prevalence of antimicrobial resistance.
    • Incorporate appropriate confidentiality protections.
    • Identify and anticipate gaps in availability of existing drugs. (Related Action Item: Product Development #79). Coordinators: CDC, FDA, USDA; Collaborators: EPA, DVA, DoD Timeline for entire action item 5: Begin within one to two years
  2. Identify and evaluate methods for collecting (e.g., optimal sampling methods) and disseminating the surveillance data on antimicrobial drug use:
    • Identify inexpensive sources of drug use data (e.g., the National Ambulatory Medical Care Survey [NAMCS], the National Hospital Ambulatory Medical Care Survey [NHAMCS], and databases in some healthcare delivery systems and pharmacies) and evaluate their usefulness for surveillance purposes Coordinators: CDC, FDA
    • Consider ways that results of periodic drug use surveys could be made available to food animal producers and veterinarians to encourage participation in data collection Coordinators: CDC, FDA, USDA Timeline for entire action item 6: Begin within one to two years
  3. Work with accrediting agencies to address antimicrobial drug-use monitoring as part of quality assurance in healthcare delivery systems. (Related Action Item: Prevention and Control #64)
    Coordinators: CDC, HCFA Timeline: Begin within one to two years

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B. Issue: Implementation of the national plan for AR surveillance will require:

  • Reliable drug susceptibility data;
  • Adequate capacity and resources at state and local health and agricultural agencies; and
  • An accessible, centralized source of AR data.

1. Goal: Promote the consistent and appropriate use of reliable laboratory tests for antimicrobial drug susceptibility.

a. Action Items

  1. Ensure that clinical laboratories that provide data for AR surveillance purposes have access to and routinely participate in pertinent training and proficiency testing programs with good performance and indicate AR testing methodologies in their surveillance reports (e.g., specific automated methods or manual techniques). Coordinator: CDC; Collaborator: HCFA Timeline: Initiated
  2. Evaluate the performance of licensed, automated AR testing devices in the context of changing resistance patterns and update their labeling where appropriate (e.g., changes in quantitative resistance that may make a test result invalid). Coordinators: FDA, CDC Timeline: Initiated
  3. Working with partners,b including the National Committee for Clinical Laboratory Standards (NCCLS), further develop, refine, and promote standardized clinical, epidemiologic, and laboratory methods for documenting and assessing the significance of drug resistance among yeasts and moulds, parasites, and viruses Coordinators: CDC, NIH, FDA, USDA, HCFA Timeline: Initiated
  4. Identify ways to overcome economic, legal, and other barriers to appropriate AR testing and to the reporting of results (e.g., sufficient human resources, cost considerations, empiric treatment recommendations, managed-care practices, etc.). (Related Action Item: Prevention and Control #34) Coordinators: HCFA, HRSA, CDC, AHRQ Timeline: Begin within one to two years
  5. Pursue legal mechanisms for manufacturers to provide otherwise unavailable drugs to government reference laboratories for the sole purpose of antimicrobial drug susceptibility testing (as part of surveillance) with the understanding that these drugs will not be used for drug discovery purposes. Coordinator: CDC Timeline: Begin within one to two years

2. Goal: Ensure that state and local health and agricultural agencies have the capacity to 18 conduct surveillance of drug-resistant organisms of public health importance.

a. Action Items

  1. With state health and agriculture departments and other stakeholders, define needed core capacity (the minimum needed in human, laboratory, and electronic resources) at the state and local level to ensure that basic AR surveillance is conducted in these jurisdictions. As part of this effort, ensure that state public health and veterinary diagnostic laboratories maintain the capacity to test the drug-susceptibility patterns of resistant organisms of public health importance, especially for drugmicroorganism combinations for which testing methods are not routinely available at hospital and commercial laboratories. Coordinators: CDC, USDA, FDA Timeline: Begin within one to two years
  2. Provide resources to assist in meeting state and local core capacity needs for AR surveillance. Strive to provide consistent funding from year to year to state and local public health and veterinary diagnostic laboratories that meet quality assurance standards. Coordinators: CDC, USDA Timeline: Initiated

3. Goal: Disseminate surveillance data in a timely manner to public health officials, clinicians, and others who may make decisions based on an analysis of the data.

a. Action Items

  1. Provide an accessible, centralized source of AR data from major surveillance systems involving animal and human populations. In consultation with stakeholders, determine how to report AR data in a way that is valid and useful to interested parties (e.g., clinicians, public health officials, veterinarians, and researchers). Include sufficient detail in surveillance reports to permit local analysis and comparison with trends in drug use and medical and agricultural practices.
    Coordinators: CDC, USDA, FDA, HCFA Timeline: Begin within one to two years
  2. Provide healthcare system administrators and other decision makers with data on the impact of drug-resistant organisms (e.g., outcome, treatment costs) and on effective prevention and control measures.
    Coordinators: CDC, AHRQ Timeline: Begin within one to two years

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C. Issue: Monitoring AR in agricultural settings is essential to ensure animal and plant health and a safe food supply.

1. Goal: Monitor AR in animal and plant pathogens and in bacteria that can be transmitted to humans through the food supply.

a. Action Items

  1. Expand and enhance coordination of surveillance for drug-resistance in enteric bacteria in sick and healthy humans and in sick and healthy animals on farms, at slaughter, and at retail. This effort includes:
    • Expanding the National Antimicrobial Resistance Monitoring System: Enteric Bacteria (NARMS:EB);
    • Comparing AR data on pathogenic and nonpathogenic organisms detected on farms (in sick and healthy animals), at slaughter, and in commercial food products; and
    • Utilizing these data to monitor the transmission of resistant infections and assess the effectiveness of prevention measures
      Coordinators: CDC, FDA, USDA
      Timeline: Initiated
  2. Evaluate the usefulness of monitoring sentinel human populations (e.g., farm, abattoir, fruit and vegetable, and food processing plant workers) and persons in the general community for infection or colonization with resistant enteric bacteria. Coordinators: CDC, USDA, FDA Timeline: Begin within three to five years
  3. Conduct pilot studies to assess the extent of environmental contamination by antimicrobial drug residues and drug-resistant organisms that enter the soil or water from human and animal waste. If contamination is detected, conduct appropriate surveillance in waste, surface and ground water, and soil from agricultural areas in which waste is used for fertilizer, and conduct studies to determine potential impact on human and animal health. (Related Action Item: Prevention and Control #55) Coordinators: EPA, CDC, USDA Timeline: Initiated
  4. Gather information on the relationship between antimicrobial pesticide and herbicide use and the emergence of drug-resistance by monitoring:
    • The prevalence and incidence of drug-resistant organisms in agricultural areas where antimicrobial pesticides are used and areas where they are not used, and
    • The prevalence of colonization or infection with resistant bacteria in human or animal populations who live or work near orchards or who consume fruit products sprayed (or treated) with antimicrobial. pesticides (Related Action Item: Prevention and Control #62)
      Coordinators: EPA, CDC, USDA
      Timeline: Begin within three to five years
 
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