Good Morning. Thank you for allowing me the opportunity to provide
comment regarding antimicrobial resistance and its impact on patients
and the health of the public. My name is Dr. Ruth Carrico and I am an
Assistant Professor in the School of Public Health and Information
Sciences at the University of Louisville. I am here today speaking on
behalf of the members of the Association for Professionals in Infection
Control and Epidemiology, APIC, a professional organization whose
mission is to improve health and patient safety by reducing risks of
infection and other adverse outcomes. APIC's 12,000 members have primary
responsibility for infection prevention, control and healthcare
epidemiology in health care settings around the globe, and include
nurses, epidemiologists, physicians, microbiologists, clinical
pathologists, laboratory technologists and public health practitioners
.  APIC advances its mission through education, research, collaboration,
public policy, practice guidance and credentialing.

For over thirty years, APIC has worked to minimize the impact of
infection in healthcare facilities and the community. This continued
reach toward elimination of healthcare associated infection remains a
challenge that is, in many respects, the direct result of drug
resistance. The cycle of infection identification, treatment with
antibiotics, selection of resistant organisms by the chosen antibiotic
agent, emergence of those resistant organisms as a pathogen is all too
familiar to the infection prevention specialists that are in most US
healthcare facilities. This cycle is a harsh example of the challenges
that result from infection and effectively demonstrate that
interventions must be multifaceted. If you ask us to identify our most
challenging and concerning issue, the impact of drug resistance will
likely be that most often cited by infection prevention specialists. In
healthcare facilities, we work tirelessly to address the complexities
involved in preventing infection transmission but we also address
multidrug-resistant organisms that emerge as collateral damage due to
appropriate, or inappropriate, use of antimicrobial agents. Using
guidance from the CDC Healthcare Infection Control Practices Advisory
Committee, or HICPAC recommendations, concerning Management of
Multidrug-Resistant Organisms In Healthcare Settings published in 2006,
healthcare facilities are charged to take a comprehensive approach in
their prevention efforts. These include the use of a systems approach to
infection prevention that incorporates education, behavior change, use
of the concepts of human factors engineering, training of healthcare
personnel, and feedback of results. Of particular importance is the need
to incorporate these activities into a program that serves to promote
the judicious use of antimicrobial agents. Unfortunately, neither the
components of such a program nor metrics for success have been clearly
articulated. Consequently, the elements of an antimicrobial stewardship
program will likely have extreme variation between facilities, if such a
program exists at all.

An antimicrobial stewardship program incorporates several key pillars
including use of accurate laboratory results to guide treatment
decisions, antibiograms that provide local information for use in
empiric therapy selections, antimicrobial therapy selection and use
guidelines, monitoring of these pillars then feedback of results.
Healthcare facilities may have some of these elements but many are
without adequate microbiology laboratories and microbiologists. Further,
staffing in healthcare facilities and crisis-type interventions such as
cross-training and supplemental staffing negatively impact the abilities
of the facility to ensure basic competence for the performance of
technique dependent procedures such as obtaining blood cultures. Without
accurate results including contamination or inappropriate volumes or
timing, the treating clinician is handcuffed and may be forced into
treatment decisions that may not accurately reflect the patient
condition. This may result in inappropriate or unnecessary therapy. In
some instances, the clinicians may rely less upon microbiologic results
and elect to treat without cultures thereby impacting the ability of the
facility to build an adequate and accurate antibiogram resulting in a
lack of guidance for empiric therapy and entry into a cascade of events
that may result in acceleration of the resistance problem. If facilities
are unable or unwilling to manage antimicrobial therapy through a
program built around adherence with appropriate selection and use
guidelines, the ability of the healthcare facility to address resistance
problems is further hampered.

As if this were not bad enough, this cycle also works to undermine the
ability and likelihood that pharmaceutical companies will invest in
appropriate research and development for new therapies. If blood culture
results are not accurate, the ability of the clinicians and
pharmaceutical companies to determine efficacy, is plagued. If we are to
expect investment in orphan drugs, this basic problem in accurately
documenting patient response must be resolved. If companies are not able
to catalogue patient responses to therapy then determine how those
responses may be related to the antibiotic under investigation, we
should not be surprised if companies are less than responsive to our
need for continued research and development

Although a primary area of focus has been infection prevention and
control in hospitals and long term care facilities, we recognize the
trend of providing an increasing amount of care outside the walls of
these traditional places for healthcare. Performance of testing,
invasive as well as non-invasive procedures, staffing constraints,
turnover and continued reimbursement decline demonstrate the need for
infection prevention programs in all healthcare settings. If we are to
address appropriate use of antimicrobial agents and minimize selective
pressure and emergence of resistance, the approach must be comprehensive
and cross all healthcare settings.

We ask for leadership from the FDA in addressing the following critical
needs:

-   Support for research surrounding elements of effective antimicrobial
    stewardship programs

-   Support for research in systems approaches to infection prevention
    across the spectrum of healthcare

-   Continued collaboration with organizations such as APIC as we
    continue to target zero as the goal for healthcare-associated
    infection, and

-   Continued collaboration with organizations such as APIC as we
    continue to strive for universal adherence to prevention practices
    supported by scientific evidence and promote a culture of zero
    tolerance for practices that stand in the way of patient safety

APIC is committed to working with all partners in achieving a healthcare
environment free from healthcare-associated infection and its
devastating results. We stand ready to support efforts of the FDA to do
the same.