Prudent Use of
Global Basic Principles
This paper presents a set of principles
governing the prudent use of antibiotics in animals, elaborated
jointly by the international representative organisations of
veterinarians, farmers, and the pharmaceutical industry. It may
form the backbone of and/or guide in the elaboration of more
The recommendations below concentrate on
the use and not on government measures such as licensing and
controls. However, the three organisations 1) fully pledged to
use antibiotics within the jurisdiction of each country; 2)
support that each country should have an appropriate regulatory
system for the licensing and control of veterinary drugs in
general and antibiotics in particular; 3) and recommend that
counterfeit and other unregistered products should not be used
and that such use be combated.
- for convenience the word
"antibiotic" is used throughout this document;
it is intended to convey all antimicrobial products
administered orally or parenterally to animals, i.e.
antibiotics (produced by fermentation of live
micro-organisms) but also chemically-synthesised
compounds with antibiotic activity such as sulphonamides
and quinolones; it does not include disinfectants.
- the basic principles are in bold
typeface; where required to facilitate the interpretation
of the principle or to add a specific recommendation,
language in regular type face has been added.
The Basic Principles
- Antibiotics are health
management tools that are licensed to be used to enhance
good husbandry practices for the purpose of
- disease prevention
- disease treatment
It is a fact that certain
antibiotics may be used in food animals for
performance enhancement, which leads to benefits
in terms of animal welfare, reduction of
environmental waste, and supply of economical
high quality source of protein. Future conditions
of use of antibiotics for this indication is
pending the outcome of on-going investigations
and international meetings expected to take place
within the near future.
Antibiotics are a
complement to good husbandry practices and should
never be used to compensate for or mask bad farm
and veterinary practices.
- Codes of good practices,
Quality assurance programmes, Herd Health Surveillance
Programmes (HHSP), and education programmes should
promote the responsible and prudent use of antibiotics.
- Antibiotics shall be used
under the supervision of a veterinarian.
Regular, close veterinary involvement is
essential for informed advice concerning the use of
antibiotics. Regardless of the distribution system
available, the use of antibiotics should be subject to
appropriate professional advice, including by a
- Therapeutic antibiotics
should be used when it is known or suspected that an
infectious agent is present which will be susceptible to
therapy. It is the responsibility of the veterinarian to
choose the antibiotic product, based on his/her informed
professional judgement balancing the risks and benefits
for humans and animals.
The veterinarian shall have due regard to the public
health risks of using veterinary medicines. Specifically
for antibiotics, the veterinarian shall have due
consideration for the potential for decreased antibiotic
susceptibility in zoonotic bacteria and target pathogens
in animals, and for the antibiotic residues of
toxicological and microbiological significance. At the
same time, benefits such as promoting the health and
welfare of animals, assuring safe, wholesome, and
affordable food from healthy animals, while reducing
human exposure to bacteria of animal origin, shall be
taken into account.
Whenever bacteria are exposed to antibiotics, there will
probably be some degree of selection for resistant
populations. Therefore, it is vital to prudent use to
limit therapeutic antibiotic use to those situations
where they are warranted.
- When antibiotics need to be
used for therapy, bacteriological diagnosis with
sensitivity testing should, whenever possible, be part of
the informed professional clinical judgement.
When treating a disease, the sensitivity of the causal
organism should ideally be ascertained before therapy is
started. In disease outbreaks involving high mortality or
where there are signs of rapid spread of disease among
contact animals, treatment may be started on the basis of
clinical diagnosis. Even so, the sensitivity of the
suspected causal organism should, where possible, be
determined so that if treatment fails it can be changed
in the light of the results of sensitivity testing.
Antibiotic sensitivity trends should be monitored over
time, and such monitoring used to guide clinical
judgement on antibiotic usage.
- Label instructions should
be carefully followed and due attention paid to species
and disease indications and contra-indications, dosage
regimen, withdrawal periods, and storage instructions.
Off-label use of antibiotics should be exceptional and
always be under the professional responsibility of a
Off-label use should be carefully justified, for instance
as part of the written prescription. Where legal
provisions exists, they should serve as a basis for
guiding the conditions of off-label use.
- Antibiotics used for
therapy should be used for as long as needed, over as
short a dosage period as possible, and at the appropriate
Dosage regimen: It is essential to administer the
antibiotic in accordance with the recommended dosage
regimen. This will minimise therapy failures, exploit
fully the efficacy potential of the product, and comply
with the regulated withdrawal times. Each class of
antibiotics has its own unique pharmacodynamic properties
which are expressed fully when the recommended dosage
regimen is applied.
As long as necessary: Insufficient duration of
administration can lead to recrudescence of the
infection. This may lead to increased likelihood of
selecting microorganisms with reduced sensitivity.
As short as possible: Limiting the duration of use to
only that required for therapeutic effect will minimise
the exposure of the bacterial population to the
antibiotic. The adverse effects on the surviving
commensal microflora are minimised and the medical impact
of the remaining zoonotic organisms is minimised/reduced.
Theoretically, antibiotic use should be stopped as soon
as the animal's own host defence system can control the
- Records should be kept of
all antibiotic administrations.
The implementation of record-keeping (ways and means,
responsible professions) should be left to the
national/local level. However, in order to ensure
compatibility and usability of recorded data, some
harmonisation of the principles and of the format is
- Co-ordinated susceptibility
surveillance should be conducted and the results be
provided to the, prescriber, supervising veterinarians
and other relevant parties.
Surveillance should target microorganisms of both
veterinary and public health importance. Data from
diagnostic laboratories (with collection of samples from
pathologic specimens) have an inherent bias towards a
higher percentage of resistant strains than pre-treatment
specimens. Therefore it is encouraged to also gather data
from samples collected at random from farm,
slaughterhouses, or food in order to investigate the
prevalence of resistance in veterinary pathogens,
zoonotic pathogens, and sentinel organisms.
Data should be provided to prescribers, supervising
veterinarians and other relevant parties; which will
allow the modification of antimicrobial usage to balance
the benefits with the risks. Accessibility to the data
will vary from programme to programme and should normally
be determined beforehand.
- Efficacious, scientifically
proven alternatives to antibiotics are needed as an
important part of good husbandry practices.
Among the research needs, it is suggested to look into
the development of economical and efficacious
alternatives to the use of antibiotics and to evaluate
the impact that these alternatives (e.g. vaccines,
probiotics, competitive exclusion principles and
products, nutrition, and new health technologies and
strategies, including improved livestock management)
might have on selection for resistance.
WVA: Marc Janssen, Dommelstraat
46, 9250 Waasmunster (Belgium) - Phone: 32-52-463031, Fax:
32-52-463235, email: email@example.com
IFAP: David King, 60 rue St Lazare, 75009 Paris (France) -
Phone: +33-145-260-553, Fax: +33-148 747 212, email: firstname.lastname@example.org
COMISA: Christian Verschueren, Rue Defacqz, 1 - 1000
Brussels (Belgium) - Phone: +32-2-541-0111, Fax: +32-2-541-0119,