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Initial Comments
A. Themes and Approaches
B. General Recommendations
C. Structure and Process
D. Specific Recommendations by Item
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Specific Recommendations by Item
INTRODUCTION AND OVERVIEW: Background,
Paragraph 5, First sentence:
With the exception of one other place in the document there
is little mention of "daycare centers." This should be highlighted
as a major potential problem and extensive (or more elaborate)
measures proposed to minimize this potential problem. We suggest
this be expanded upon in the Prevention and Control Section.
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I. SURVEILLANCE,
We urge that the Introduction to the Surveillance Section
include:
1. a background discussion on the current mechanism/methodology
for determining organisms and susceptibility
2. a description of the existing surveillance systems
3. a discussion of current standards and methodologies
(17):
To guarantee sustainability, there needs to be a clearer determination
of where funding resources will be coming from on a continual
basis. Also, funding for private sector initiatives that complement
the Federal government's abilities should be encouraged.
(19):
We urge that HCFA be added to the coordinators or collaborators
because they are involved in reimbursement of laboratory tests
that are pertinent to research and surveillance.
(21-22):
Populations working with agriculture may have significant levels
of antibiotic resistance; this was shown as early as 1976. However,
current studies have not focused on this issue. There is a need
for further study and information concerning human populations
that work with agriculture. Likewise, testing water and soil
for antibiotic residues should be a higher priority in the research
section of the Action Plan. If soil and water are contaminated,
this has many public health implications.
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II. PREVENTION AND CONTROL SECTION
We recommend that throughout this section, the term "stakeholder"
be defined as broadly as possible. At a minimum, this should
include academia and non-profit organizations.
(24):
This should be based on disease trends and antibiotic efficacy.
(31):
This should be a first priority within six months since the
FDA is currently reviewing this matter. The Interagency Taskforce
should solicit advice from appropriate private organizations.
(33):
We suggest that the Final Action Plan include a definition or
explanation of "drugs of last resort," what criteria are used
to place a drug on this list, and how the list is modified.
(34):
We question whether "home parenteral antimicrobial treatment"
is the only reimbursement policy that needs to be examined.
(38):
There should be industry and private involvement here.
(39):
There should be industry and private involvement here. What
are the reimbursement mechanisms?
(40):
Although unnecessary laboratory tests should not be compensated,
certain useful tests which will target therapy and reduce unnecessary
use should be encouraged in regulatory and financing provisions.
(D)(Issues):
This issue statement is too narrow. It should also address indirect
transfer through the environment.
(52 -54):
These action items discuss the need for gathering research to
determine the risks and benefits of antimicrobial use in agriculture.
It is important that more neutral, government-sponsored research
be available to guide policy debates. Two Institute of Medicine
committees, in 1988 and 1998 , produced comprehensive reports
on the subject; a careful review of these studies and their
conclusions provides an adequate basis for more aggressive action
on antibiotic use in agriculture. Meanwhile, there should be
an immediate special assessment of the potential impact of fluoroquinolone
use in animals. This approved use seems unnecessary and risky
and should be reevaluated as soon as possible.
(65):
We recommend replacing "periodic" with "ongoing" and including
"non-profit associations and academia" as stakeholders.
(E)(3. Goal):
We urge that this goal be expanded to include "health professions
education."
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III. RESEARCH
Introduction, Paragraph 2: It is our view that the Action
Plan would be improved and more comprehensive if it listed the
specific research questions that have been identified as well
as the existing gaps and efforts that are underway.
(A)(1. Goal):
We urge this goal to be rewritten to read as follows: "Identify
gaps, address existing research needs, and identify new ones."
(B)(Issue):
We recommend that the Final Action Plan describe the existing
research infrastructure and needs (Federal and private).
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IV. PRODUCT DEVELOPMENT
This section generally raises important issues: There is
a need to build concrete requirements and incentives for industry
to provide products or antibiotic resistance data, especially
if it means they might face consequences that negatively impact
their markets.
(87):
We urge caution here. The Action Plan advocates "streamlining
the regulatory and approval process for veterinary and agricultural
antimicrobial drugs and related products that are unlikely to
result in transfer of antimicrobial resistance to humans." This
is of concern because antibiotic resistance to several different
antibiotics may be linked on the same plasmid. These linked
antibiotics may not even be in similar classes of drugs. More
linkage research should happen before certain drugs are streamlined
through the approval process.
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