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 specific guidelines.

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.

Notes:

1. 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.
2. 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

1. Antibiotics are health management tools that are licensed to be used to enhance good husbandry practices for the purpose of
   1. disease prevention
   2. disease treatment
   3. production enhancement

      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.
      

2. Codes of good practices, Quality assurance programmes, Herd Health Surveillance Programmes (HHSP), and education programmes should promote the responsible and prudent use of antibiotics.
   
   
3. 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 veterinarian.
   
   
4. 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.
   
   
5. 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.
   
   
6. 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 veterinarian.
   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.
   
   
7. 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.
   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 infection itself.
   
   
8. 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 needed.
   
   
9. 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.
   
   
10. 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: m.janssens@ping.be
IFAP: David King, 60 rue St Lazare, 75009 Paris (France) - Phone: +33-145-260-553, Fax: +33-148 747 212, email: ifap@club-internet.fr
COMISA: Christian Verschueren, Rue Defacqz, 1 - 1000 Brussels (Belgium) - Phone: +32-2-541-0111, Fax: +32-2-541-0119, email: comisa@fedesa.be