A PUBLIC HEALTH ACTION PLAN TO
COMBAT ANTIMICROBIAL RESISTANCE
PART 1: DOMESTIC ISSUES
Interagency
Task Force on Antimicrobial Resistance
Co-chairs:
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Agency for Healthcare Research and Quality
Health Care Financing Administration
Health Resources and Services Administration
Department of Agriculture
Department of Defense
Department of Veterans Affairs
Environmental Protection Agency
A
PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE
PART 1: DOMESTIC ISSUES
TABLE OF CONTENTS
Executive Summary Page 2
Top Priority Action Items Page 7
Introduction
and Overview Page 89
The Focus Areas
I. Surveillance (Action Items 1-2220) Page 1213
II. Prevention and Control (Action Items 23-6921-66)
Page 1920
III. Research (Action Items 70-8167-78) Page 3032
IV. Product Development (Action Items 82-8779-84) Page 3537
References
Page 3941
Index (to be added in final version)
A PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE
EXECUTIVE SUMMARY
This Public Health Action Plan to Combat Antimicrobial Resistance (Action Plan) was
developed
by an interagency Task Force on Antimicrobial Resistance that was created in
1999. The Task Force is co-chaired by the Centers for Disease Control and
Prevention, the Food and Drug Administration, and the National Institutes of
Health, and also includes the Agency for Healthcare Research and Quality, the Department of Agriculture, the Department of
Defense, the Department of Veterans Affairs, the Environmental Protection
Agency, the Health Care Financing Administration, and the Health Resources and Services
Administration., the
Department of Agriculture, the Department of Defense, the Department of
Veterans Affairs, and the Environmental Protection Agency.
The
Action Plan reflects a broad-based consensus of federal agencies on actions
needed to address antimicrobiala
resistance (AR),.
which was reached based on iInput from consultants
from state and local health agencies, universities, professional
societies, pharmaceutical companies, health care delivery organizations, agricultural
producers, consumer groups, and other members of the public was
important in developing this plan. While some actions are already
underway, complete implementation of this plan will require close collaboration
with all of these partnersb,
a major goal of the process. The plan will be implemented incrementally,
dependent on the availability of resources.
The
Action Plan provides a blueprint for specific, coordinated federal actions to
address the emerging threat of antimicrobial resistance. This document is Part
I of the Action Plan, focusing on domestic issues. Since AR transcends national
borders and requires a global approach to its prevention and control, Part II
of the plan, to be developed subsequently, will identify actions that more specifically
address international issues. The Action Plan, Part I (Domestic Issues),
includes four focus areas: Surveillance, Prevention and Control, Research, and
Product Development. A summary of the Priority Goals and Action Items in each
Focus Area follows. below. A
complete list is found in pages 12-38.
Unless
AR problems are detected as they emerge – and actions are taken quickly to
contain them – the world may soon be faced with previously treatable diseases which that have
again become untreatable, as in the pre-antibiotic era. Priority Goals and
Action Items in this focus area address ways to:
A
coordinated national AR surveillance plan for monitoring AR in microorganisms
that pose a threat to public health will be developed and implemented. The plan
will specify activities to be conducted at national, state, and local levels,;
define the roles of participants,; promote the use of standardized
methods,;
and provide for timely dissemination of data to interested parties, e.g.,
public health officials, clinicians, and researchers. Needed core capacities at
state and local levels will be defined and supported. When possible, the plan
will coordinate, integrate, and build upon
existing disease surveillance infrastructure. All surveillance activities will
be conducted with respect for patient and institutional confidentiality.
The availability of reliable drug susceptibility data is essential for AR surveillance. The accuracy of AR detection and reporting will be improved through training and proficiency testing programs for diagnostic laboratories and by promoting and further refining standardized methods for detecting drug resistance in important pathogens, including bacteria, parasites, fungi, and viruses. Public and private sector partners will address barriers to AR testing and reporting, e.g., barriers due to changes in healthcare delivery.
A plan to monitor patterns of antimicrobial drug use will be developed and implemented as an important component of the national AR surveillance plan. This information is essential to interpret trends and variations in rates of AR, improve our understanding of the relationship between drug use and resistance, and help identify interventions to prevent and control AR.
Improved surveillance for AR in agricultural settings will allow early detection of resistance trends in pathogens that pose a risk to animal and plant health, as well as in bacteria that enter the food supply. Agricultural surveillance data will also help improve understanding of the relationship between antimicrobial drug and pesticide use and the emergence of drug resistance.
The
prevention and control of drug-resistant infections requires measures to
promote the prudent appropriate usec
of antimicrobial drugs and prevent the transmission of infections (whether
drug-resistant or not). Priority Goals and Action Items in this focus area
address ways to:
Prudent Appropriate drug-use
policies will be implemented through a public health education campaign that promotes prudenton appropriate antimicrobial
drug use as a national health priority. Other actions in support of prudent appropriate drug
use will include reducing inappropriate prescribing through development of clinical guidelines,guidelines
and computer-assisted decision support, consideration
of regulatoryconsidering
regulatory changes, and
supporting other interventions that promote promoting education
and behavior change among clinicians, and informing consumers about the uses
and limitations of antimicrobial drugs.
Improved
diagnostic practices will be promoted, including by encouraging the use of rapid
diagnostic methods to guide drug prescribing, facilitating
direct consultation between clinicians and laboratory personnel with
appropriate expertise and the
appropriate use of clinical laboratories, and
appropriate t esting methods by those laboratoriesauthority, and promoting
the use of appropriate laboratory testing methods.. Improved diagnostic practices will be promoted
through guidelines, training, and regulatory and reimbursement policies. Guidelines, training, and regulatory and
reimbursement policies will be utilized to promote improved diagnostic practices.
Reduced
rates of infection transmission
will be addressed through public health campaigns that promote vaccination and
hygienic practices such as hand hygiene washing, and safe
food handling, and other behaviors associated with prevention of
infection transmission. Infection control in health care settings
will be enhanced by developing new interventions based on rapid diagnosis,
improved understanding of the factors that promote cross-infection, and
modified medical devices or procedures that reduce the risk of infection.
The
prevention and control of AR in agriculture and
veterinary medicine requires 1) improved understanding of the
risks and benefits of antimicrobial use and ways to prevent the emergence and
spread of resistance; 2) development and implementation of principles for prudent appropriate antimicrobial
drug use in the production of food animals and plants; 3) improved animal
husbandry and food-production practices to reduce the spread of infection; and
4) a regulatory framework to address to need for antimicrobial drug use in
agriculture and veterinary medicine while ensuring
that such use does not pose a risk to human health.
Comprehensive,
multi-faceted programs involving a wide variety of non-federal partners and
the public are required to prevent and control AR. The AR Task Force agencies
will ensure ongoing input from,
and review by,
and collaboration with non-federal partners. The appropriate agencies will
support demonstration projects that use multiple interventions to prevent and
control AR (e.g., through surveillance, judicious appropriate drug use, optimized
diagnostic testing, immunization practice, and infection control). The Task
Force agencies will encourage the incorporation of effective programs into
routine practice by implementing model programs in federal health-care systems
and promoting the inclusion of AR prevention and control activities as part of
quality assurance and accreditation standards for health care delivery
nationwide.
Understanding
of the fundamental processes involved
in antimicrobial resistance within microbes and the resulting impact on humans,
animals, and the environment forms an important basis for influencing and
changing these very processes and outcomes. Basic and
clinical research provides the fundamental knowledge necessary to develop
appropriate responses to antimicrobial resistance emerging and spreading in
hospitals, communities, farms, and the food supply. Priority Goals and Action
Items in this focus area address ways to:
Needs
in the field of AR research will be identified and addressed through a
government-wide external program review with external input. Additional research
is needed, for example, on the epidemiology of resistance genes; on mechanisms
of AR emergence, acquisition, spread, and persistence; and on the effects of
antibiotics used as agricultural growth promotants on microbes that live in
animals, humans, plants, soil and water. Further study is also required to
determine whether variations in drug use regimens may stimulate or reduce AR
emergence and spread. Improved understanding of the causes of AR emergence will
lead to the development of tools for reducing microbial resistance, as well as
for predicting where AR problems are likely to arise.
A
comprehensive research infrastructure will help ensure a critical mass of
AR researchers who will interact, exchange information, and stimulate new
discoveries. This will be achieved through the appropriate mechanisms
strategies and scientific conferences that promote research on AR. The AR Task
Force agencies will work with the academic and industrial research communities
to attract AR researchers, prioritize needs, identify key opportunities, and
optimize the utilization of resources to address AR problems.
The
translation of research findings into innovative clinical products to
treat, prevent, or diagnose drug-resistant infections is an area in which the federal government can play an
important role, focusing on gaps not filled by the pharmaceutical industry or
by other non-governmental
groups. Special efforts will be placed on the identification, development and
testing of rapid, inexpensive, point-of-care diagnostic methods to facilitate judicious appropriate use
of antimicrobials. The AR Task Force agencies will also encourage basic
research and clinical testing of diagnostic methods, novel treatment
approaches, new vaccines and other prevention approaches for resistant
infections.
As antimicrobial drugs lose their effectiveness, new products must be developed to prevent, rapidly diagnose, and treat infections. The Priority Goals and Action Items in this focus area address ways to:
Current and projected gaps in the arsenal of AR products and potential markets for these products will be reported to researchers and drug manufacturers through an interagency working group convened to identify and publicize priority public health needs.
The
development of urgently needed AR products will be stimulated throughout the process from drug
discovery through licensing. The regulatory process for AR products will
continue to be streamlined, and incentives that promote the production and
appropriate use of priority AR products will
can be evaluated in pilot programs
that monitor costs and assess the return on the public investment.
The
production of veterinary AR products that reduce the risk of development
and transfer of resistance to drugs used in human clinical medicine will be
expedited through a streamlined regulatory and approval process. As with drugs
for the treatment of human infections, pilot programs will can be initiated to evaluate
incentives to encourage the development and appropriate use of priority
products that meet critical animal and plant health needs.
Private and public partners will also evaluate ways to improve or reduce the agricultural use of particular antimicrobial drugs, as well as ways to prevent infection, such as the use of veterinary vaccines, changes in animal husbandry, and the use of competitive exclusion products (i.e., treatments that affect the intestinal flora of food animals).
(All 11
13 items have top priority, regardless
of their order in the list)
(Action Item #39)
·
Create an Interagency AR Product Development Working
Group to identify and publicize priority public health needs in human and
animal medicine for new AR products (e.g., innovative drugs,
targeted spectrum antibiotics, point-of-care diagnostics, vaccines and other biologics, anti-infective
medical devices, and biologics
disinfectants). (Action Item #8279)
·
In
consultation with stakeholders, economic consultants, and the AR Product
Development Working Group, iIdentify
ways (e.g. financial and/or other incentives or investments) to promote the
development and/or judicious appropriate use
of priority AR products, such as
novel compounds and approaches, for human and veterinary medicine
for which market incentives are inadequate. (Action Item #8380)
In the 1940s, the widespread availability of penicillin and the subsequent discovery of
streptomycin led to a dramatic reduction in illness and death from infectious diseases. However, bacteria and other disease-causing organisms - viruses, fungi, and parasites - have a remarkable ability to mutate and acquire resistance genes from other organisms and thereby develop resistance to antimicrobial drugs. When an antimicrobial drug is used, the selective pressure exerted by the drug favors the growth of organisms that are resistant to the drug’s action. The extensive use of antimicrobial drugs has resulted in drug resistance that threatens to reverse the miracles of the last half century.
Drug-resistant pathogens are a growing menace to all people, regardless of age, gender, or socioeconomic background. They endanger people in affluent, industrial societies like the United States, as well as in less developed nations. Examples of clinically important microbes that are rapidly developing resistance to available antimicrobials include bacteria that cause pneumonia, ear infections, and meningitis (e.g., Streptococcus pneumoniae1), skin, bone, lung, and bloodstream infections (e.g., Staphylococcus aureus2,3), urinary tract infections (e.g., Escherichia coli4), foodborne infections (e.g., Salmonella5), and infections transmitted in health care settings (e.g., enterococci6 and Klebsiella spp.7).
For
example, up to 30 percent of S. pneumoniae found in some areas of the
United States are no longer susceptible to penicillin, and multidrug resistance
is common. Approximately 11 percent of S. pneumoniae are resistant to
‘third generation’ cephalosporin antibiotics, and resistance to the
newest fluoroquinolone antimicrobials has already been reported.8 Nearly all strains of Staphylococcus aureus in the United
States are resistant to penicillin, and many are resistant to newer methicillin-related
drugs.2 Until 1997,
vancomycin was the only uniformly effective tretment for S. aureus infections. Since
1997, however, strains of S. aureus with
decreased susceptibility to vancomycin, for many years the only uniformly
effective treatment, have been reported.9,10
Many
other pathogens - including the bacteria that cause tuberculosis 11 and gonorrhea,12 the virus
that causes AIDS, human
immounodeficiency virus,13 the fungi that cause
yeast infections,14 and the parasites that cause malaria 15 - are also becoming resistant to standard therapies. If we do
not act to address the problem of AR, we may lose quick and reliable treatment
of infections that have been a manageable problem in the United States since
the 1940s. Drug choices for the treatment of common infections will become
increasingly limited and expensive - and, in some cases, nonexistent.
While
anyone may acquire a drug-resistant infection, certain people are at increased
risk, e.g., patients in hospitals and children in daycare centers.
Drug-resistant infections may be acquired in health care settings (e.g.,
staphylococcal infections in intensive care units), in the community (e.g.,
pneumococci acquired from a classmate) and through the food supply (e.g., salmonella
acquired from meat or eggs), both domestically and overseas. However, resistant
microbes are increasingly appearing in new settings. Methicillin-resistant S.
aureus, which for 30 years with few exceptions was a problem only in
hospitals, is now occurring in the community.3,16
Solutions
AR will always be with us. The challenge before us is to transform this increasingly urgent threat into a manageable problem. Over the past ten years, the Institute of Medicine,18 the American Society for Microbiology,19 World Health Organization 20 other panels of distinguished experts, the Congressional Office of Technology Assessment,17 and the General Accounting Office 21, 22 have provided recommendations and options for government action to address the dangers posed by AR. The experts agree that we need to improve surveillance for emerging AR problems, to prolong the useful life of antimicrobial drugs, to develop new drugs, and to utilize other measures, e.g., improved vaccines, diagnostics, and infection control measures to prevent and control AR.
Despite the urgency of the problem, the achievement of these goals has not been simple or straightforward, and accomplishments to date have been insufficient. Monitoring, preventing, and controlling AR requires sustained effort, commitment, and collaboration among many groups in the public and private sectors, and involvement of the general public. It also requires support and leadership from the federal government and a willingness to address complex and sometimes controversial scientific, medical, and economic issues.
This Public
Health Action Plan to Combat Antimicrobial Resistance provides a blueprint
for specific, coordinated federal actions to address this emerging threat. The
Plan builds upon reports prepared by expert panels in recent years. This
document is Part I of the Plan, focusing on domestic issues. SinceHowever, AR transcends national borders
and requires a global approach to its prevention and control., Part II of the plan, to be developed
after the World Health Organization finalizes its Global Strategy
for the containment of Antimicrobial Resistance,23, will identify actions that more
specifically address international issues with input
from and in collaboration with WHO and additional partners. A National
Action Plan to Combat Multi-drug Resistant Tuberculosis has
been published previously.2224
Partnerships
and Implementation Plan
Development
This
plan was developed by an Interagency Task Force on Antimicrobial Resistance
that was created in 1999. The Task Force is co-chaired by the Centers for
Disease Control and Prevention (CDC),
the Food and Drug Administration (FDA), and the National Institutes of Health
(NIH), and also includes the Agency for Healthcare Research and Quality (AHRQ),
the Health Care Financing Administration (HCFA),
the Health Resources and Services Administration (HRSA), the
Department of Agriculture (USDA), the Department of Defense (DoD), the
Department of Veterans Affairs (DVA), and the
Environmental Protection Agency (EPA)., the Health
Care Financing Administration (HCFA), and the Health Resources and Services
Administration (HRSA).
The plan is
based in part on input obtained at a public meeting held in Atlanta, Georgia,
in July 1999. 25 Present at the public meeting were consultants from
a wide variety of groups, including state and local health agencies,
universities, professional societies, pharmaceutical and biotechnology companies,
health care delivery organizations, agricultural producers, consumer groups,
and the public. A draft of the plan was released for public comment in June
2000, 26 and the plan was modified following consideration
of comments received.
The
Plan reflects a broadly-based consensus of federal agencies on actions to
combat AR. The Plan is based in part on input from a public
meeting held in Atlanta, Georgia, in July 1999. 23 Present at the meeting were consultants from a wide
variety of groups, including state and local health agencies, universities,
professional societies, pharmaceutical and biotechnology companies, health care
delivery organizations, agricultural producers, consumer groups, and the public.
However, Iimplementation of this plan will
require collaboration with all of these many partners.b More specific details of these collaborations will
be developed by the agencies as the actions are implemented.
The plan will be implemented
incrementally, as resources and, where
needed, new appropriations, become available. The agencies
recognize that a number of the items may require either new statutory authority
or the adoptions of changes in regulatory requirements. The extent to which
such measures may be needed to implement a given action item will be considered
by the agencies involved.
The
Plan includes a summary and a list of issues, goals, and action items
addressing surveillance, prevention and control, research, and product
development.d
Except where specified, these issues, goals, and
action items apply to human AR issues and not to non-human (e.g., agricultural)
issues. Agricultural issues refer to the production of animals and plants, as
well as fish and other species (aquaculture). For each action
item, “coordinator”
and “collaborator”
agencies/departments are specified. Contingent on available resources, the
coordinators will assume the primary responsibility of carrying out the
specified action items and the collaborators will assist and/or carry out part
of the specified action. Additional
agencies may become collaborators in the future.The Interagency Task Force will monitor and, if
necessary, update the Plan, during the coming years.
The Task Force identified 13 top priority action items.
Approximate timelines were also identified for all action items; these
timelines provide another indication of priority but also take into account
prerequisites for certain items and the achievable pace of action on sometimes
complex issues. Designation of top priorities and timelines was a difficult
task given the realization that many items could be considered top priority and
should ideally begin immediately. For action items with multiple component
parts, the agencies involved will further develop priorities and timelines,
with appropriate input from outside partners, as they implement
the action
item.
The
Interagency Task Force will continue to facilitate coordination among agencies
and monitor implementation of the plan. During the coming years, the Task Force
will publish periodic reports detailing how the plan is being implemented,
solicit comments from the public, - and if necessary, update the plan.
Details of current agency activities regarding AR are beyond the scope of this
document, but may be obtained by contacting the specific agencies.
THE FOCUS AREAS
I. SURVEILLANCE
INTRODUCTION
Surveillance of AR is critical to provide early warning of emerging problems, monitor
changing
patterns of resistance, and target and evaluate prevention and control
measures.e
Timely
surveillance information is also necessary to assistfor assisting researchers in
developing new drugs and for good patient care. For example, clinicians should
be informed of drug resistance problems in their communities that may influence
their prescribing decisions and 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 upon
enhanced epidemiologic and laboratory
capabilities
at local, state, and national levels, ; use of standardized and reliable
laboratory testing methods, ; and enhanced enhancing use of informatics.
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 non-human settings.
1. Goal:
Collaborate with appropriate partners to develop procedures and methods for nationwide 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 - Identify the
components of a national
AR
surveillance plan and the roles of partners in its design and implementation.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
infections microbes in
humans, and
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, UDSA, FDA, EPA
§
Similarity,Explore the use
of standardized definitions and
methodology (Related Action Item: Surveillance #5) to create an electronic
surveillance system that health care 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., MICs minimal
inhibitory concentrations or zone diameters) in ways that will
detect decreased susceptibility. This isThese standards are necessary because
numerical AR test results reported non-quantitatively
(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
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 that recognizes the differences in human
and animal medicine and
food production agriculture 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 related toassociated 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 on 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 non-culture
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 non-human settings
a. Action Item
(5) TOP PRIORITY ACTION ITEM - Develop and implement procedures for
monitoring antimicrobial drug use in human medicine,
in agriculture, veterinary medicine, and in consumer products:
§
Incorporate
appropriate confidentiality protections in these procedures
§ 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
(6) 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 health care 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
(7) Work with accrediting agencies to address
antimicrobial drug-use monitoring as part of quality assurance in health care
delivery systems. (Related Action Item: Prevention and Control #6764)
Coordinators: CDC, HCFA
Timeline: Begin within one to two years
(8) Convene a working group to assess the possible
need for additional federal regulations to facilitate and protect
confidentiality in antimicrobial drug use monitoring programs.
Coordinators:
CDC, USDA, FDA
Timeline:
Begin within one to two years
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
(98) Ensure that clinical laboratories
that provide data for AR surveillance purposes have clinical access to and
routinely participate in pertinent training and applicable 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
(109) Evaluate the performance of
licensed, automated AR testing devices in 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: Begin within
one to two yearsInitiated
(1110) Working
with partners,b including the National Committee for
Clinical Laboratory Standards (NCCLS),
further develop, to
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. antifungal susceptibility testing methods for
yeasts and molds.
Coordinators: CDC, NIH, FDA, USDA,
HCFA
Timeline: Initiated
(12) Develop and promote standardized clinical,
epidemiologic, and laboratory methods for documenting drug resistance among
parasites (e.g., lice, Trichomonas, Giardia).
Coordinators:
CDC, NIH
Timeline:
Begin within three to five years
(1311) Identify ways to overcome economic,
legal, and other barriers to appropriate AR testing and to the reporting of
results (e.g., reimbursement policies, managed-care practices,
sufficient human resources, cost
considerations, empiric treatment recommendations, managed-care
practices, etc.). (Related Action Item: Prevention and Control #3734)
Coordinators: HCFA, HRSA, CDC, AHRQ
Timeline: Begin within one to two years
(1412) Identify aPursue 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 conduct surveillance of drug-resistant organisms of public health importance.
a. Action Items
(1513)
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 drug-microorganism 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
(1614) Provide resources to assist in
meeting state and local core capacity needs for AR surveillance. Strive to
prove consistent funding from year to year to state and local public health and
veterinary diagnostic laboratories that meet quality assurance standards.
Coordinators: CDC, USDA, FDA
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
(1715) 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
(1816) Provide health-care 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
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
(1917) Expand and enhance coordination of
surveillance for drug-resistance in enteric bacteria in sick and healthy
humans, and sick and healthy animals on
farms, at slaughter, and at retail. This effort may include:
§ Expanding the National Antimicrobial Resistance Monitoring System:
Enteric Bacteria (NARMS:EB);
§ Comparing AR data on pathogenic and non-pathogenic 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
(2018) 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
(2119) Conduct pilot studies to assess
the extent and impact of environmental
contamination by antimicrobial drug residues and drug-resistant organisms that
enter the soil or water from human and animal waste. If appreciable contamination
is detected, conduct routine or sentinel appropriate
surveillance in waste, in surface and ground water, and in 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 #5855)
Coordinators: EPA, CDC, USDA
Timeline: Begin within
three to five yearsInitiated
(2220) 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 and are not usedused and
areas where thy 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 #6462)
Coordinators: EPA, CDC, USDA
Timeline: Begin within three to five years
II. PREVENTION AND CONTROL
INTRODUCTION
Prevention and control of drug-resistant infections
requires measures to promote the prudent appropriate use
of antimicrobial drugs and prevent
infection transmission. (i.e.,
maximizing their therapeutic effect while minimizing the potential for
development of resistance). The concept
of appropriate use may be expressed in various other ways, e.g., good
antimicrobial stewardship of judicious, prudent, or rational use. In this Action Plan, appropriate
antimicrobial drug use is defined as use that maximizes therapeutic impact
while minimizing toxicity and the development of resistance. In practice, this
means prescribing antimicrobial therapy when and only when beneficial to a
patient; targeting therapy to the desired pathogens; and using the appropriate
drug, dose, and
duration. Appropriate antimicrobial drug use should
not be interpreted simply as reduced use because these drugs offer valuable
benefits when used appropriately. It is overuse and misuse that must be
decreased to reduce the selective pressure favoring the spread of resistance.
Prudent
antimicrobial drugAppropriate
use can be facilitated in various
ways, e.g., by promoting appropriate informed prescribing by clinicians,
informing consumers about the proper
uses and limitations of antimicrobial
drugs, and improving diagnostic techniques. The challenge
facing public health organizations is to work with partners to identify
effective methods of promoting appropriate antimicrobial drug use and to
translate these interventions into routine medical practice.
Measures to prevent infection transmission of infection, whether drug-resistant
or not, are also very important in controlling AR.
These include the appropriate use of vaccines and infection control,
sanitation, and hygiene measures, and other
safe behaviors, e.g., safe sexual practices.. Efforts to control
drug-resistant infections must become part of everyday practice in health-care
settings across the nation, as well as in other settings (e.g., agriculture and veterinary medicine) in which
antimicrobial drugs are used. Partners in many sectors of society, as well as
the general public, will need to be involved in this effort.
A. Issue: Appropriate
use of antimicrobial drugs can offer great benefits to patients, but Overuse overuse and
misuse of antimicrobial these drugs
can hasten the development of resistance and shorten the drug’s useful life.
1. Goal:
Identify effective methods for promoting judicious appropriate antimicrobial
use.
a. Action Items
(2321) Identify factors that promote or
impede judicious appropriate drug
use in hospitals, extended care facilities, and outpatient settings, working in collaboration with partners.b health policy researchers and organizations that
can help implement AR prevention and control strategies.
Coordinator: CDC; Collaborators: FDA, AHRQ, DVA,
DoD
Timeline: Initiated
(2422) Develop judicious drug use
policies and evaluate the effectiveness (including cost-effectiveness) of
implementing these policies in hospitals and other health-care
delivery settings. Identify ways to increase adherence to judicious appropriate use policies proven to be effectivebeneficial in
collaboration with partners.b
Coordinator: CDC; Collaborators: AHRQ, FDA, DVA,
DoD, HCFA
Timeline: Initiated
health effects of these practices in
collaboration with partners.b
Coordinators: CDC, FDA
Timeline: Begin within three to five years
(2624) Help individual hospitals and
health care systems analyze how the availability of AR data and
computer-assisted decision support systems influences
prescriber behavior, health outcomes, and costs. This may include the provision of computer software and the establishment of projects that involve the Medicare Peer Review Organizations (PROs).
Coordinator: CDC; Collaborators: HCFA, DVA, DoD
Timeline: Begin within three to five years
2. Goal:
Promote judicious appropriate antimicrobial use
through educational and
behavioral interventions found to be effective.
a. Action Item
(2725) TOP PRIORITY ACTION ITEM - Develop and implementConduct a public health education strategy campaign to
promote judicious appropriate antimicrobial
use as a national health priority. The strategy campaign should
involve patients, clinicians, educators, industry, and
policy makersmany partners.b Elements of this campaign may
include:
§ Culturally appropriate educational and behavioral interventions implemented through community-based programs that target patients and selected populations and communities, such as daycare centers and schools;
o Patients and selected populations and communities,
such as daycare
centers and
schools
o Prescribing clinicians
o Health care delivery-systems
§
Strategies to
improve patient adherence to appropriate therapies;
§
A clearinghouse for educational materials (e.g.,
booklets and CD-ROM presentations) on judicious appropriate drug use and AR prevention;
§ A periodically updated priority list of drug-resistant microorganisms in
humans and animals; and
§ A glossary disseminated through CDC Website that defines technical words
commonly used in discussions of AR issues.
Coordinator: CDC; Collaborators: USDA, FDA, HCFA
Timeline: Begin within one to two years
(28) Work with pharmaceutical manufacturers to
implement programs directed at
clinicians and the public that promote judicious
antimicrobial drug use for priority drug-pathogen combinations. Consider
providing incentives to participating companies. (Related Action Item: Product
Development #83)
Collaborator:
CDC; Collaborators: USDA, FDA, HCFA
Timeline: Begin within one to two years
(26) TOP PRIORITY ACTION ITEM - In collaboration with many partners,b
develop and
facilitate the implementation of educational and behavioral
interventions
that will assist clinicians in appropriate antimicrobial prescribing.
Examples may
include:
§
Educational
curricula and training modules for all prescribing clinicians,
as part of
quality assurance programs;
§
Clinical
guidelines that address appropriate antimicrobial use;
§
Informatics
technology (e.g., computer-assisted decision support) to assist
§
Culturally
appropriate materials and methods to help clinicians explain to
patients the
benefits and limitations of antimicrobial drugs and the
importance of
appropriate use of these drugs; and
§
Material that
could be included in licensing, board certification, and
credentialing
examinations.
Coordinators:
CDC, FDA; Collaborators: DoD, DVA, HRSA, HCFA
Timeline:
Initiated
3. Goal: Promote judicious antimicrobial use through guidelines, regulatory changes,
and public policy actions
a. Action Items
(29) TOP PRIORITY ACTION ITEM - In collaboration
with professional societies and
other stakeholders, develop, disseminate, and evaluate clinical guidelines that
address:
·
Judicious
antimicrobial use
·
Self-care and
symptomatic treatment for common viral infections
·
Advice to
patients on how to help prevent the emergence of AR infections through
appropriate use of antimicrobial drugs
Coordinators: CDC, FDA; Collaborator: NIH
Timeline:
Initiated
(3027) Explore ways to integrate judicious appropriate use
information into antimicrobial package inserts and promotional materials, to
provide such information to patients with each prescription, and to provide
clear guidance to industry to ensure that promotion of antimicrobials directed
towards consumers does not encourage inappropriate or unneeded useencourages appropriate use and discourages
inappropriate use.
Coordinator: FDA; Collaborator: CDC
Timeline: Begin within
one to two yearsInitiated
(3128) Articulate factors that support
the current approach of requiring prescription-only dispensing for all systemic
(i.e., non-topical) antimicrobial drugs used in clinical medicine.
Coordinator: FDA; Collaborator: CDC
Timeline: Begin within three to five
yearone to two years
(3229) Periodically review and update
antimicrobial drug susceptibility information included in drug labeling, with input from stakeholders and other experts,
e.g., in coordination with the National
Committee for Clinical Laboratory Standards (NCCLS) and CDC.
Coordinator: FDA; Collaborator: CDC
Timeline: Begin within one to two years
(3330) Convene an advisory panel or other
expert group involving stakeholders and partnersb to consider issues related to resistant pathogens that cause
serious infections for which available treatment options are very limited or
nonexistent. the management of drugs of last resort for the
treatment of resistant infections. Issues for
discussion might include:
§
Criteria for
designating such drug-pathogen combinations;
§
Compiling and
updating a list of such drug-pathogen combinations;
§
Recommendations
for diagnosis and management of patients with
suspected or
documented infection, including where appropriate that
selected
important drugs be preferentially used for the treatment of
conditions associated with organisms that are
resistant to other drugs;
§
Publicizing
and facilitating access to clinical trials or compassionate use of
investigational
therapies;
§
Recommendations
for preventing infection transmission;
§
Recommendations
for performance and reporting of susceptibility test
results for selected important drugs by clinical
laboratories including
possibly that
they be reported to clinicians only on request if an organism
is sensitive
to other appropriate drugs;
§
Monitoring
the use of selected important drugs, with consideration of
changes in
product labeling by FDA and in recommendations for use if
increased resistance is detected; and
§
Promoting
early and wide adoption of prudent use guidelines
§
Establishing
intensive surveillance of drugs of last resort, with mechanisms for triggering
changes in product labeling and use when increased resistance is detected
§
Labeling by FDA of
selected important drugs of last
resort with the recommendation that they be preferentially used
for the treatment of conditions associated with organisms that are resistant to
other drugs. (Related Action Item: This item will also be considered
in conjunction with Product Development #80.)
Coordinator: FDA, CDC; Collaborator: CDC
Timeline: Begin within one to two years
(3431) Convene a working group to examine
the impact of federal reimbursement
policies for home parenteral antimicrobial treatment, on judiciousappropriate antimicrobial use, and
appropriate use of antimicrobial susceptibility testing. Where
needed, the working group will make recommendations for modifying these
policies.
Coordinator: HCFA; Collaborators: CDC, HRSA
Timeline: Begin within one to two years
(3532) Develop and submit measures for
appropriate antimicrobial use to the National Committee for Quality Assurance
for inclusion in Health Plan Employer Data and Information Set (HEDIS), which
provides comparative data on managed
care organizations.
Coordinator: CDC; Collaborator: HCFA
Timeline: Initiated
B. Issue: Improved diagnostic practices can enhance antimicrobial use and patient
care.
1. Goal: Identify and promote the widespread use of diagnostic testing and reporting
strategies that effectively facilitate judicious appropriate use of antimicrobial drugs
in routine practice
a. Action Items
(3633) Evaluate the potential impact of
improved diagnostic tests, including rapid
point-of-care tests on antimicrobial drug use and
patient care, and assess their financial implications. Take into account tests
that distinguish between bacterial and viral infections; tests that identify
resistant pathogens; and tests that distinguish common clinical syndromes entities such
as bacterial sinusitis and acute bacterial otitis media from illnesses with
similar manifestations for which antimicrobials are not beneficial. (Related
Action Item: Research #7976)
Coordinator: CDC, FDA, NIH;
Collaborators: DVA, DoD
Timeline: Begin within one to two years
(3734) Identify economic and other
barriers in the health care system (e.g.,
reimbursement policies by third-party payers, managed care practices, cost
considerations, empiric treatment recommendations, etc.) to diagnostic testing that promotes appropriate use of antimicrobials. Develop recommendations that remove disincentives or promote incentives to such testing.
Coordinator: HCFA; Collaborators: CDC, HRSA; AHRQ
Timeline: Begin within three to five years
(3835) In collaboration with professional
societies, industry, health departments, and other
stakeholders and partnersb, develop
guidelines for use by clinicians and clinical
microbiology laboratories that address:
§ Appropriate specimen collection;
§ Performance, interpretation, and reporting of antimicrobial (including antibacterial, antifungal, antiviral, and antiparasitic) susceptibility tests performed on clinical specimens; and
§ Use of in-office (point-of-care) tests for infection, including AR infections.
Coordinator: CDC; Collaborator: FDA, DoD, DVA, HCFA, HRSA
Timeline: Begin within three to five years
(3936) In collaboration with professional
societies, industry, health departments, and other
stakeholders and partnersb, develop
guidelines for use by health-care-delivery organizations that
address the use of clinical microbiology laboratories for use by
health care delivery organizations. The guidelines will:
§ Promote access to clinical microbiology services by clinicians;
§ Promote access to appropriate on-site microbiology services in acute
care facilities;
§ Allow physicians to submit specimens to clinical laboratories other than
those designated by their health care delivery
organization or the patient’s insurance company, with appropriate
justifications; and
§ Facilitate direct consultation between clinicians and laboratory personnel with appropriate expertise and authority.
Coordinator: CDC; Collaborator: HCFA for bullet 2.
Timeline: Begin within three to five
yearsone to two years
(4037) Promote the increased performance
of direct examination of microbiological specimens (e.g., by Gram stain or
other rapid method), in
circumstances where appropriate, clinically relevant, and reliable information can be garnered, as a readily available point-of-care diagnostic test. This step will require working within the framework of the Clinical Laboratory Improvement Amendment (CLIA) regulations and involving medical education and health care delivery organizations.
Coordinator: CDC; Collaborator: HCFA
Timeline: Begin within one to two years
C. Issue: Preventing infection transmission through improved infection control,
behaviors that prevent infection (e.g., safe sexual practices), and use of
vaccines can help prevent the spread of antimicrobial resistance.
1. Goal: Identify ways to reduce disease transmission in health-care settings and in
the community
a. Action Items
(4138) Identify factors that promote
transmission of drug-resistant pathogens in health-care facilities, in extended
care facilities, and in community settings such as daycare centers and in the community at large. These
may include characteristics of the facilities and of the populations that they
serve.
Coordinator: CDC; Collaborators: DVA, DoD
Timeline: Initiated
(4239) TOP PRIORITY
ACTION ITEM - Evaluate the effectiveness (including
cost-effectiveness) of current and novel infection-control practices for
health care and extended care settings and in the community. Promote adherence
to practices proven to be effective.strategies
used in hospitals and other health-care delivery settings.
Coordinator: CDC; Collaborators: DoD, DVA, HCFA, HRSA
Timeline: Initiated
(43) Identify ways to increase adherence to
infection-control practices proven to
be effective in previous studies.
Coordinator:
CDC; Collaborators: DoD, DVA
Timeline:
Initiated
(4440) Evaluate the cost-effectiveness
and impact on patient care and drug resistance of medical devices that
incorporate anti-infective compounds to prevent
infection (e.g., anti-infective urinary catheters and prosthetic heart valves).
Where appropriate, (e.g., shown
to be effective and not induce resistance), encourage the clinical
use of these devices. (Related Action Item: Product Development #8582)
Coordinator: CDC; Collaborators: AHRQ, DoD, DVA,
FDA, HRSA,
HCFA
(4541) Encourage the development and implementation of clinical
alternatives to those invasive medical procedures and devices that increase the
risk of infection in hospitals and other health care settings,
e.g., substitution of transcutaneous monitoring
of blood oxygen levels of indwelling catheters.
Coordinator: CDC; Collaborators: FDA, DVA
Timeline: Begin within three to five years
(4642) Evaluate the benefits and risks of
incorporating antimicrobial, disinfectants, or antiseptic chemicals into
consumer products (e.g., soap, toys, kitchen utensils, clothes, paints,
plastics, and film preservatives) and of
applying disinfectants and sanitizers to hard, non-porous surfaces such as food-contact
surfaces, hospital premises, bathrooms, etc. Consider whether they: have any efficacy in reducing infection and/or may
play a role in
promoting drug resistance.
§
Have any
efficacy in reducing infection
§
May play a
role in promoting drug resistance
Coordinators: CDC, EPA; Collaborator: FDA
Timeline: Begin within
three to five yearsInitiated
2. Goal: Promote infection control through behavioral and educational interventions
a. Action Items
(4743) Conduct a public health campaign
to promote hand hygiene and other
hygienic practices that prevent the transmission of infectious organisms, in
collaboration with professional societies and
stakeholders. This campaign may be coordinated with the public health education
strategy to promote judicious appropriate antimicrobial
use described in Action Item #2725: Prevention and Control. Components
will include: developing, evaluating, and facilitating the
implementation of school-based and other programs that promote hand hygiene and
other behaviors
that prevent infection, building on previous campaigns (e.g., American Society
of Microbiology’s Operation
Clean Hands).27
§
Evaluating
the curricula of school hygiene courses
§
Funding
school based and other programs that promote hand hygiene and other behaviors
that prevent infection
§
Building on
previous campaigns (e.g., ASM’s Operation Clean Hands)
Coordinator: CDC
Timeline: Begin within one to two years
(44) Facilitate
and support the activities of infection control programs in health
care settings
as a component of medical care. Promote infection control education
at all stages
of training and practice for all health care workers who have contact with
patients.
Coordinator:
CDC; Collaborators: DVA, HCFA, DoD, HRSA
(4845) Support ongoing public health
education campaigns on food-safety such as
FDA and USDA’s Fight BAC
program,2428 whose aim is to educate food
producers, suppliers, retailers, and consumers about food safety practices
that reduce foodborne infections (including AR
infections).2529
Coordinators: USDA, CDC, FDA
Timeline: Initiated
reduce bacterial contamination of food.
Coordinator: CDC
Timeline: Begin within one to two years
3. Goal: Optimize the use of vaccines to prevent drug-resistant infections and reduce
antibiotic use
a. Action Items
(5047) Support community-based programs
that promote and facilitate availability of recommended vaccinations for adults
and children.
Coordinator: CDC
Timeline: Initiated
(5148) Identify vaccines useful in reducing preventing drug-resistant
infections and reducing antimicrobial drug use, and
evaluate novel methods for improving coverage with these vaccines. For example:
§ Evaluate the risks and benefits of allowing certain vaccines for adults (e.g., for pneumococci and influenza virus) to be dispensed by pharmacists without prescription and
§ Review and evaluate methods to promote administration of pneumococcal vaccines (e.g., offering vaccination when patients are discharged from the hospital), and encourage the use of methods found to be effective.
Coordinator: CDC; Collaborators: DVA, FDA, HCFA
Timeline: Begin within three to five years
D. Issue: Prevention and control of drug resistance in agriculture and veterinary
medicine is important to promote
animal and plant health, as well as to
in preventing
AR transmission to humans through the food supply or through contact with
infected animals or the environment.
1. Goal: Improve understanding of the risks and benefits of antimicrobial use, and
ways to prevent the emergence and spread of drug resistance, in agricultural and veterinary settings.
a. Action Items
(5249) Evaluate the nature and magnitude
of the impact of using various antimicrobial drugs as growth promotants in
different species, using current animal husbandry practices. Use this
information to assist in risk-benefit
assessments of such use.
Coordinator: USDA; Collaborators: CDC, FDA
(5350) Conduct additional research to
further define the effects of using various
veterinary drugs on the emergence of resistant bacteria that infect or colonize food animals of different species, using various animal husbandry practices. Identify risk factors and preventive measures. Assess the associated risk of:
§ Transmission of AR infections to humans;
§ Clinical disease in humans; and
§ Transfer of resistance factors from animal flora to human flora.
Coordinators: CDC, USDA, FDA
Timeline: Initiated
(5451)
Conduct epidemiologic and laboratory studies to assess the risk of development
and transfer of resistance related to the use of antimicrobial
drugs in food and non-food
plants, and identify risk factors and potential
preventive measures.
Coordinator: USDA; Collaborators: CDC, FDA, EPA
Timeline: Initiated
(5552) Develop rapid tests for inspecting
fresh commodities like fruit for evidence of contamination with bacteria that
are resistant to antibiotics.
Coordinator: USDA; Collaborators: EPA, FDA, CDC
Timeline: Begin within one to two years
(5653) Evaluate the effect of current
food processing and distribution methods on
the emergence and spread of drug-resistant organisms.
Coordinator: USDA; Collaborators: CDC, FDA
Timeline: Begin within one to two years
(5754) Identify and evaluate new food
pasteurization strategies.
Coordinator: USDA; Collaborators: FDA, CDC
Timeline: Begin within three to five years
(5855) Assess the risk of AR emergence
and spread due to environmental contamination by antimicrobial drugs or by
resistant bacteria in animal and
human waste. Collect information on whether environmental
contamination by antimicrobial drugs can lead to the development of resistance
in bacteria that live in the soil or in water. (Related Action Item:
Surveillance #2119)
Coordinators: USDA, CDC, EPA, FDA
Timeline: Initiated
colonization and infection with drug-resistant organisms in the animals and their human household contacts.
Coordinator: CDC
2. Goal: Promote judicious appropriate antimicrobial use in
agricultural settings.
a. Action Items
(6057) Work with veterinary and
agricultural communities to help educate users of veterinary and agricultural
antimicrobial about AR issues, and promote the implementation and evaluation of
guidelines that address these issues:
§
Judicious Appropriate antimicrobial use in
agricultural settings;
§ Performance and interpretation of antimicrobial susceptibility tests performed on specimens from different species of animals; and
§ Point-of-care tests for infection, including AR infections.
Coordinators: USDA, CDC, FDA; Collaborator: EPA
Timeline: Initiated
(6158) TOP PRIORITY ACTION ITEM - In
consultation with stakeholders, refine and implement the proposed FDA framework
2630 for approving new antimicrobial drugs
for use in food-animal production and, when appropriate, for re-evaluating
currently approved veterinary antimicrobial drugs. The proposed
framework includes the following major steps:
§
Categorize
antimicrobial drugs according to their importance in human
medicine.
Timeline:
Initiated
§
Develop an
approach to the establishment of thresholds for drug resistance
in selected pathogens.
§
Revise
requirements for the industry’s submission of drug use data.
Timeline:
Initiated
§
Develop
procedures to assess microbial safety of antimicrobial drug use in
food-producing
animals.
Timeline:
Initiated
In support of
the concepts articulated in the framework document:
§
Conduct risk
assessments on the human health impact of using selected
antimicrobials important in human medicine in
food-producing animals
Timeline:
Initiated
§
Initiate
appropriate steps to address any unacceptable human health impact, if
identified by the risk assessments, for drugs categorized as being of critical
importance in human medicine
Timeline: Begin within one to two years
Coordinator:
FDA
Coordinator:
FDA
Timeline:
Initiated
(6259) Strongly encourage involvement of
veterinarians in decisions regarding the use of systemic antimicrobial drugs in
animals, regardless of the distribution system through which the drug is
obtained (e.g., regardless of whether a prescription is required to obtain the
drug).
Coordinators: FDA, USDA
Timeline: Initiated
(6360) Evaluate the potential impact of
making all systemic veterinary antimicrobial drugs available by prescription
only.
Coordinators: FDA, USDA
Timeline: Begin within three to five years
(6461) Convene an expert group to
consider how to incorporate AR issues into regulations governing the use of antimicrobials and antibiotic
pesticides. Invite external experts, stakeholders, and the public to provide
input.
Coordinator: EPA
Timeline: Begin within one or two years
E. Issue: Efforts to prevent and control AR emergence and spread must be
comprehensive
and multifaceted, and involve a wide variety of non federal
partners and the public, and become a part of routine practice nationwide.
1. Goal: Ensure input from non-federal experts on federal efforts to combat
antimicrobial resistance
a. Action Items
(6562) Establish an ongoing mechanism to
obtain periodic input from external experts on AR issues. This will include
ensuring input from stakeholders and partners b(e.g., state and local health
agencies, the private sector, and the public) in developing and reviewing
federal efforts to address antimicrobial resistance.
Coordinators: CDC, FDA, NIH; Collaborators: USDA, EPA,
DoD, DVA,
AHRQ, HRSA, HCFA
Timeline: Begin within one to two
years three to five years
2. Goal: Develop and evaluate comprehensive demonstration programs to prevent
and control AR
a. Action Items
(6663) TOP PRIORITY ACTION ITEM -
Support demonstration projects to evaluate comprehensive programs strategies that use multiple
interventions to promote judicious appropriate drug use and reduce
infection rates. These projects will include:
§
Assess how interventions found effective in research
studies can be applied effectively
on a routine basis and on a large scale and how this application can be done
most cost-effectivelyroutinely and
most cost-effectively on a large scale;
§ Evaluate the use of these programs in health care systems (federal and non-federal), in the community, and in agricultural and veterinary settings; and
§ Involve partnerships with local and state agencies, health care systems, professional societies, community organizations, schools, private industry, and the public.
Coordinator: CDC; Collaborators: FDA, DVA, DoD, HRSA, HCFA,
USDA
Timeline: Initiated
a. Action Items
(6764) Utilize federal health care
systems (e.g., DoD, VAHDVA,
etc.) as models systems for
AR surveillance and prevention and control activities involving judicious appropriate drug
use, optimized diagnostic testing, infection control, and vaccination practice.
Coordinator: CDC, DVA, DoD,
HCFA, HRSA; Collaborators:
DVA, DoD, HCFA, HRSA
Timeline: Begin within three to five years
(6865) For all health care systems for
which federal funds are provided, identify and promote strategies to establish
AR prevention and control activities as part of quality monitoring programs.
Coordinator: CDC DVA, DoD,
HCFA, HRSA; Collaborators:
DVA, DoD, HCFA, HRSA
Timeline: Initiated
(6966) Encourage nationally recognized
accrediting agencies such as the National Committee for Quality Assurance
(NCQA) and the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO), to
include accreditation standards that promote efforts to prevent and control AR,
including judicious appropriate antimicrobial
use, infection control, vaccine use, and diagnostic testing. These standards may
draw on the findings of existing data and demonstration programs and AHRQ
Evidence-Based Practice Centers.
Coordinator: CDC; Collaborators: HCFA, AHRQ
Timeline: Begin within one to two years
III. RESEARCH
Antimicrobial resistance is among the most challenging problems in microbiology, clinical medicine, and public health. Antimicrobial resistance is not one problem, but an
overarching
term for a whole array of problems inherent in
the evolution of microbes and influenced by antimicrobial use. Basic and clinical research provides the
fundamental knowledge necessary to develop appropriate responses to
antimicrobial resistance emerging and spreading in hospitals, communities,
farms, and the food supply. Microbiology,
the study of microorganisms, tells us that the processes by which drug
resistance occur, are essentially those of evolution. To evolve is to change,
and this change is inevitable. Basic and clinical research provides the
fundamental knowledge necessary to develop appropriate responses to
antimicrobial resistance emerging and spreading in hospitals, communities,
farms, and the food supply. Major scientific accomplishments
throughout the years have contributed much to the understanding of the
fundamental biological processes of AR within microbes and the resulting impact
on human, animals, and the environment.
and This
knowledge base provides us the opportunity to influence these very processes and outcomes.
TheBecause of
its broad scope,
of the U.S. research community has a
major contribution to make in meeting the challenge
of AR in order to reach the goals the AR Task Force has set forth.
The research and development of diagnostic tests, new antimicrobial agents,
novel therapeutic products, and vaccines and other preventive approaches in
response to AR is a multi-step
process that begins with basic research discoveries and ends with the
availability and use of a new product or implementation of a process. Along
this pathway three areas need to be addressed: the identification of gaps and
needs in the molecular and cellular understanding of resistance, the
infrastructure to support a robust research community, and finally a
pathway for movement of a means for
moving research findings into the
development of new products.
Through efforts of tThe Interagency Task Force ,has worked with representatives from the public and
private sector to identify important research questions
aboutneeds in
microbial
physiology, ecology, genetics and mechanisms of resistance.
have been identified. Existing gaps in
knowledge and understanding should be addressed to augment the federal and
private sector response to the overall problem. Efforts are underway to build
and enhance the field of AR research, through increased focus, recognition, and
collaboration. The aim is to develop a research infrastructure to support a
critical mass of AR researchers who will interact, exchange information, and
stimulate new discoveries. In order to move novel ideas arising at the research
bench in the
research laboratory to useful products or approaches, support of
the underlying infrastructure to study and test products and a mechanism to
transition to industrial partners is necessary.
This effort will involve federal agencies that conduct, support and promote basic and
clinical research in academia and industry and will involve prioritizing needs, identifying
key opportunities, recruiting new investigators to the field, and making responsible use of
ecology, genetics and mechanisms of resistance.
1. Goal: Identify gaps
and Aaddress
existing research needs and identify new ones.
a. Action Items
(7067) Additional research, including high risk and high payoff research in
nontraditional fields, is needed to enhance the understanding and
assess the
impact of:
§ Mechanisms of AR emergence, acquisition, spread, persistence, and
decline, with special regard to multi-drug resistant organisms;
§
Emergence and transfer of resistance genes among
microorganisms in vivo,
including epidemiologic factors;
§
Microbial
ecology and the role of normal flora as a repository of resistance
factors, as well as the use of susceptible bacterial populations in the control of antimicrobial resistance;
§
Effects of preventive, therapeutic, and
growth-promoting agents and residues
of agents in the environment on the microbiota of animals, plants,
soil, and aquatic environments;
§
Host factors and immune modulators (e.g., cytosine cytokines)
in clinical resistance to treatments for opportunistic infections;
§
The
determinants of colonization and infection with drug-resistant pathogens; and
§ Variations in antimicrobial use patterns that may affect the emergence and
spread of resistance and the outcome of treatment, includingsuch as:
o Differences in duration and dosage in the administration of antimicrobial agents;
o Prophylactic use of antimicrobial (including antibacterial and
antifungal) agents;
o Drug combinations used to treat resistant organisms; and
o The rotation (cycling) of antimicrobial
drugs and other similar changes in selection and use of
drug classes. to prevent
the emergence
of resistance
o The
determinants of colonization and infection with drug-resistant
pathogens
Coordinator: NIH; Collaborators: CDC, FDA, DVA,
USDA, EPA, DoD
Timeline: Initiated
(7168) Conduct further government-wide, in-depth,
assessments with external input on of the scope and composition of AR
research to identify research opportunities.
Coordinators: NIH, CDC, FDA, USDA; Collaborators:
DoD, DVA,
AHRQ, EPA, HCFA
Timeline: Initiated
B. Issue: The existing research infrastructure needs to ensure a critical mass of
researchers in AR and related fields.
1. Goal: Augment the scientific research infrastructure
a. Action Items
(7269) Work with the appropriate peer
review structures to ensure that the requisite expertise is applied to the
review process to facilitate funding of quality AR research.
Coordinators: NIH, DVA, FDA
Timeline: Begin in one to two years
(7370) TOP PRIORITY ACTION ITEM -
Provide to the research community
genomics and other powerful technologies to identify targets in critical areas
for the development of new rapid diagnostics
methodologies, novel therapeutics, and interventions to prevent the emergence
and spread of resistant pathogens. Examples include tools such as microbial
genome sequences, information on comparative genomics, DNA chip technology, and informatics, and
assistance in the application and use of these tools.
Coordinator: NIH; Collaborators: DoD, USDA, FDA
Timeline: Initiated
(7471) Encourage sharing of AR data
between industry and the research community, including
genomics and other technologies.
Coordinator: NIH; Collaborators: DoD, USDA, FDA
Timeline: Begin in three to five years
2. Goal: Develop a critical mass of researchers in AR
a. Action Items
(7572) Bring new researchers into the
field, by utilizing appropriate strategies such as training and research
opportunities.
Coordinator: NIH; Collaborators: CDC, FDA, USDA,
DoD, DVA
Timeline: Initiated
(7673) Organize conferences that address
research issues relating to AR.
Coordinator: NIH; Collaborators: CDC, USDA, FDA,
DVA, DoD, AHRQ
Timeline: Initiated
C. Issue: Special efforts are needed to translate research findings into medically useful
products for human and agricultural/veterinary use, such as novel antimicrobial therapeutics, diagnostic tests, vaccines and other tools for preventing AR emergence and spread.
1. Goal: Address the governmental role in translating novel ideas into new clinically
relevant products, focusing on gaps not filled by pharmaceutical industry and other non-government groups.
a. Action Items
(7774) Explore the need to encourage
preclinical studies on the toxicology, pharmacokinetics, and pharmacodynamics
of novel therapeutic agents for
the treatment of multi-drug-resistant
pathogens and facilitate the transition
of potential products from preclinical to clinical studies leading to development by industry of novel therapeutic agents.
Coordinator: NIH; Collaborators: DoD, DVA, FDA,
USDA
Timeline: Begin within one to two years
(7875) TOP PRIORITY ACTION ITEM -–
In consultation with academia and the private
sector, identify and conduct Develop a human
clinical studies trials
network, involving medical research centers and
health-care institutions, to
coordinate
and conduct clinical trials addressing AR issues of public health significance that are unlikely to
be studied in the private sector, such as: that are
difficult to resolve in
industry-sponsored studies, including:
§ Existing antimicrobials administered in treatment regimens and
combinations that may not be included in approved indications and dosing schedules; and
§ Other products and practices relevant to the control and treatment of
antimicrobial-resistant pathogens including devices, diagnostics, antimicrobial soaps, disinfectants, etc.
Coordinator: NIH; Collaborators: CDC, DVA, DoD,
FDA
Timeline: Begin within one to two years
2. Goal: Develop rapid, inexpensive, point-of-care diagnostic methods to facilitate
judicious appropriate use of antimicrobials.
a. Action Items
(7976) TOP PRIORITY ACTION ITEM -
Identify, develop, test, and evaluate the impact of
new rapid diagnostic methods for human
and veterinary uses with partners including academia and the private sector..
Such methods should be accurate, affordable, and easily implemented in
routine clinical settings and may include:
§ Tests for resistance genes that are associated with drug resistance including non-culture specimens;
§ Rapid point-of-contact diagnostics for patients with viral respiratory infections and clinical syndromes such as otitis media, sinusitis, and pneumonia; and
§ Rapid methods for detecting drug resistance among fungi, parasites, viruses, and mycobacteria.
Coordinators: NIH, FDA; Collaborators: DoD, USDA,
CDC, AHRQ,
DVA
Timeline: Initiated
3. Goal: Develop new products and strategies to prevent and treat colonization and
infection with resistant organisms in patients, prevent transmission of resistant infections in the community, and prevent AR emergence
a. Action Items
(8077) TOP PRIORITY
ACTION ITEM - Encourage basic and clinical research
in support of the development and appropriate use of vaccines in human and veterinary medicine in partnership
with academia and the private sector. Vaccines are needed to:
§
Prevent prevalent viral
infections that predispose patients to
and are difficult to differentiate from bacterial
infection or are mistaken for bacterial infections and
are inappropriately presumptively
treated with antibacterial agents (e.g., influenza virus);
§ Prevent colonization, infection, and transmission of resistant organisms such as enterococci and staphylococci; and
§ Prevent common bacterial infections (S. pneumoniae, nontypable Haemophilus influenzae) to reduce antibacterial use
Coordinators: NIH, FDA; Collaborators: CDC, DoD,
DVA, USDA
Timeline: Initiated
(8178) Encourage basic and clinical research in support of
novel approaches to preventing or treating infections with resistant organisms that occur in humans and animals by partnering
with academia and the private sector. Novel approaches may
include:
§ Bacteriophage therapy;
§ Active (vaccine) and passive (antibody, hyperimmune globulin) immunization;
§ Host-derived antimicrobial agents;
§
Non-antibiotic
antimicrobials and nonchemical approaches with broad
or nonspecific anti-infective activities (e.g., defending and non-specific immunostimulants, such as defensins, ribozymes, etc.); and
§ Microbial ecology (probiotics, direct fed microbials, etc.).
Coordinator: NIH; Collaborators: DoD, DVA, FDA,
USDA, CDC
Timeline: Initiated
IV. PRODUCT DEVELOPMENT
INTRODUCTION
New products are not being developed rapidly enough to address increasing microbial
resistance. Needed products include not only new classes of antimicrobials able to kill
otherwise resistant organisms, but also vaccines and anti-infective devices with the potential to prevent infections as well as improved diagnostic tools to aid in appropriate
use of therapeutics. With respect to antimicrobial drugs, each new agent represents a
major investment by a pharmaceutical company, which must shepherd the product through pre-clinical studies and clinical testing, followed by large and expensive clinical trials. Pharmaceutical companies may be reluctant to invest extensive resources in the
development of drugs, such as those antimicrobials targeted to resistant organisms, which
are often given for short time periods to small numbers of patients. Manufacturers are
similarly concerned that judicious use policies may limit sales and profits. On the other
hand, when a drug is used widely, allowing recovery of costs and profitability, resistance
may develop more rapidly and shorten the useful life of the drug.
Due to these economic realities – as well as to scientific limitations and a lag in the
perception of a need for new agents – very few novel antimicrobial drugs have reached the market for several years. A major aim of this interagency effort is to work with the
private sector to explore and test innovative ways to address these issues. Approaches to
be considered include providing incentives (and overcoming disincentives) to promote and assist the development of important products to address AR.
Product development is also a very important issue for veterinary medicine and agriculture. U.S. agencies and private sector partners must intensify efforts to encourage
the development and use of veterinary drugs and agricultural practices that are unlikely to
stimulate resistance to important human drugs or spread resistant pathogens to humans. Again, increased attention also needs to be turned to strategies to prevent infections of
animals (e.g., vaccines, changes in husbandry) and to the improved use of existing and
new
products.
A. Issue: Researchers and drug manufacturers need to be better informed of current
and projected gaps in the arsenal of antimicrobial drugs, vaccines, and diagnostics, and of potential markets for these products.
1. Goal: Provide a systematic assessment of the current status and projected future
needs for AR products.
a. Action Items
(8279) TOP PRIORITY ACTION ITEM -
Create an Interagency AR Product Development Working Group to identify and
publicize priority public health needs in human and
animal medicine for new AR products (e.g., innovative drugs,
targeted spectrum antibiotics, point-of-care diagnostics, vaccines and other biologics, anti-infective
medical devices, and disinfectantsbiologics).
The Working Group will take these
steps:
§ Obtain input from stakeholders, including pharmaceutical companies, physicians, epidemiologists, and microbiologists, on which products are needed;
§
Include Involve experts in the non-medical
disciplines (e.g., engineering and remote sensing, etc.);
§ Model future resistance trends, product needs, and potential markets (particularly for novel and narrow spectrum uses), taking into account AR surveillance data and numbers of patients at high risk of developing drug resistant infections (e.g., increases in immunocompromised patients);
§
Evaluate current market incentives for the development
of priority AR products (Related Action Item: Product Development #8380)
§ Reassess AR product priorities on a regular basis;
§
Evaluate the
availability of currently approved, critical products where
shortages or
potential for shortages exists and develop an approach to
ensure that the supply of such products is adequate
to meet public health
needs; and
§
Communicate
the information and priorities developed by the Workgroup
to inform and
allow coordination with planning and action efforts in research,
prevention and control, and product development.
Coordinators: FDA, USDA, CDC; Collaborators: NIH,
AHRQ
Timeline: Begin within one to two years
B. Issue: Existing market incentives and regulatory processes may be insufficient to
stimulate the development of certain priority AR products while fostering their appropriate use.
1. Goal: Investigate and act upon potential approaches for stimulating and speeding
the entire AR product
development process, from drug discovery through licensing.
a. Action Items
(8380) TOP PRIORITY ACTION ITEM - In consultation with stakeholders, economic
consultants, and the AR Product Development Working Group
(Related
Action Item: Product Development #82), iIdentify
ways (e.g. financial and/or other incentives or investments) to promote the
development and/or judicious appropriate use
of priority AR products, such as
novel compounds and approaches, for human and veterinary medicine
for which market incentives are inadequate.
§ This process should include consultation with outside stakeholders, economic consultants, and the AR Product Development Working Group (Related Action Item: Product Development #79).
§
All such proposals will require careful economic
modeling and analysis. New approaches should be used on a trial basis, for limitedappropriate time periods, and the costs and benefits of
incentives used in these pilot programs should be monitored to assess the
return on the public investment.
§
Similar
incentives should be explored for ensuring adequate availability of
existing
products that meet critical public health needs but for which
market
incentives are inadequate to assure supply. (Related Action Item:
Product
Development #79).
Coordinators: FDA, CDC; Collaborators: USDA, AHRQ
Timeline: Begin within three to five
yearsone to two years.
(8481) Consider, Iin
consultation with academia and industry, consider whether
government has a constructive role to play in discovery of drugs and other
products targeted to address areas where market incentives are limited and
unmet needs exist (e.g., novel antimicrobial drugs targeted to specific
resistant organisms). (Related Action Items: Research Issue B)
§ Such a role could utilize intramural, extramural or partnership type mechanisms. Products developed under such mechanisms could be licensed commercially either with or without specific stipulations regarding use.
Coordinator: NIH; Collaborators: USDA, FDA, CDC
Timeline: Begin within three to five years
(8582) Continue ongoing approaches that
streamline the regulatory process, including clinical trials and enhanced
pre-clinical studies (e.g., use of pharmacokinetics, and pharmacodynamics data),
to help bring AR products (including drugs, vaccines, diagnostics and devices)
to market as efficiently and rapidly as possible, while still assuring their
safety and efficacy.
§
This approach might
involve use of an expedited process in which certain drugs are considered for
approval, after the
completion of Phase 2 clinical trials, in accordance with Subpart
E of the Investigational New Drug (IND) regulations. It might also involve
defining new surrogate endpoints that indicate a meaningful response benefit
over existing treatments for particular infections (e.g., HIV-1 RNA
viral loads or CD4 counts as surrogate markers in the treatment of
HIV/AIDS), in accordance with Subpart H of New Drug Application (NDA)
regulations.
§ In the case of approvals for anti-infective medical devices, AR concerns
will be addressed during the pre-and post-licensing
review, to ensure that these products reduce infection without engendering
significant resistance.
§ For products specifically targeted to serious or life-threatening AR infections, for which there are few therapeutic alternatives, develop approaches for more focused development programs that would streamline product availability. This should be done in consultation with all of the stakeholders in the process.
Coordinator: FDA; Collaborator: USDA
Timeline: Initiated
C. Issue: The development and use of antimicrobial drugs and related products in
agriculture and
veterinary medicine should be optimized to reduce the development andthe
transfer of resistance to pathogens that can infect humans.
1. Goal: Promote the development and use of new and existing AR products that
reduce the risk of the development and transfer of antimicrobial resistance to humans, as well as new approaches to reducing agricultural and veterinary use of antimicrobial drugs.
a. Action Items
(8683) In consultation with stakeholders
and expert consultants, identify ways to promote the development of new and
alternative veterinary treatments and the improved use of existing therapies
that are unlikely to stimulate resistance to drugs in clinical human medicine. This action will
include consideration of the incentives and approaches listed in Action Items #31
(Prevention and Control), #80 (Product
Development), #28 (Prevention and Control), and #78 (Research) and
the implementation of pilot programs to stimulate the development of priority
products that meet critical animal health needs.
§ Approaches for evaluation should include ways to improve and/or reduce the use of specific antimicrobial drugs, as well as ways to prevent infection, such as vaccines, changes in animal husbandry, and the use of competitive exclusion products (e.g., treatments that affect the intestinal flora of food animals).
Coordinators: FDA, USDA, NIH, CDC, EPA
Timeline: Begin within three to five years
(8784) Streamline the regulatory and
approval process for veterinary and
agricultural antimicrobial drugs and related products that are
unlikely, now or in the future, to result in
transfer of antimicrobial resistance to humans.
Coordinators: FDA, EPA, USDA
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a In this
document, the term “antimicrobial” is used inclusively to refer to any agent
(including an antibiotic) used to kill or inhibit the growth of microorganisms
(bacteria, viruses, fungi, or parasites). This term applies whether the agent
is intended for human, veterinary or agricultural applications.
b Implementation
of this Action Plan requires working with a wide variety of partners,
e.g., state and local health agencies, universities, professional societies,
pharmaceutical and biotechnology companies, health care delivery organizations,
insurers, agricultural producers, consumer groups, and the public. A wide
variety of expertise is needed, e.g., from clinicians, consumers, pharmacists,
microbiologists, epidemiologists, behavioral and social scientists, economists,
health policy researchers, and others. Partners and expertise needed will vary
with different action items.
c In this Action Plan, appropriate antimicrobial drug use is defined as use that maximizes therapeutic impact while minimizing toxicity and the development of resistance. In practice, this means prescribing antimicrobial therapy when and only when beneficial to a patient; targeting therapy to the desired pathogens; and using the appropriate drug, dose, and duration.
d Except where specified, these issues, goals, and action items apply to human AR issues and not to nonhuman (e.g., agricultural) issues. Agricultural issues refer to the production of animals and plants, as well as fish and other species (aquaculture).
e Public health surveillance is the ongoing, systematic collection,
analysis, and interpretation of data for use in the planning, implementation,
and evaluation of public health practice. Desirable qualities of any system
include simplicity, flexibility, acceptability, sensitivity, and representativeness.
A surveillance system also includes the timely
dissemination
of these data to persons who can undertake effective prevention and control
activities, including clinicians, researchers, laboratorians and public health
personnel. MMWR, Guidelines of Evaluating Surveillance Systems, May 6,
1988/37(S5); 118.