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.