Purpose: To minimize the negative public health impact of the use of antimicrobial agents in food-producing animals whilst at the same time providing for their safe and effective use in veterinary medicine.
- National governments should adopt a proactive approach to reduce the need for antimicrobials in animals and their contribution to antimicrobial resistance and to ensure their prudent use (including reducing overuse and misuse), as elements of a national strategy for the containment of antimicrobial resistance.
2. Relevant authorities should develop strategies that reduce the actual and potential risk to public health from antimicrobial-resistant bacteria and resistance genes, prolong the efficacy of veterinary antimicrobial products, ensure the maintenance of animal health, and establish systems for controls and interventions to ensure compliance with the developed strategies and regulations on the use of antimicrobials.
RESPONSIBILITIES OF REGULATORY AND OTHER RELEVANT AUTHORITIES
- Pre- and post-approval
3. Decisions concerning the licensing of veterinary antimicrobial substances should consider the impact on human health – of antimicrobial resistance developing in food animals in which antimicrobials have been used.
4. No antimicrobial should be administered to animals unless it has been evaluated and authorized for such use by relevant authorities. Exceptionally, where no antimicrobial drug for use in a species or for a specific indication is authorized, or an authorized product is demonstrated to be no longer effective, then a product authorized for another indication or other species may be used under direct supervision of a veterinarian. However, relevant authorities which regulate extra label use of antimicrobials in food animals should consider restricting such use of those drugs deemed highly important in human medicine.
- The authorization of veterinary antimicrobial products should take account of data on antimicrobial resistance among relevant bacterial strains and should ensure that recommended dosages are optimal for therapy, taking into consideration pharmacokinetics, clinical efficacy, residues, and, if available, other relevant data in order to minimize the development of resistance. Existing product labeling should also be reviewed, when necessary, by regulatory authorities to ensure that the recommended dose and duration of use are consistent with current knowledge of efficacy, antimicrobial resistance, pharmacokinetics, pharmacodynamics and prudent use.
6. A risk-based evaluation of the potential human health effects of all uses of antimicrobial drugs in food producing animals should be conducted, including currently approved products. In the evaluation of currently approved products, priority should be given to those products considered most important in human medicine. Characterization of the risk should include consideration of the importance of the drug or members of the same class of drug to human medicine, the potential exposure to humans from antimicrobial-resistant bacteria and their resistance genes from food animals, as well as other appropriate scientific factors. Those antimicrobials judged to be essential for human medicine should be restricted and their use in food animals should be justified by culture and susceptibility results.
7. Decisions regarding registration of antimicrobials for use in food animals should be based on scientific data and, unless otherwise justified, should include the potential rate and extent of resistance in relevant bacteria associated with the proposed use in food animals in the pre-approval evaluation.
8. Post -approval surveillance is indispensable and surveillance of resistance to antimicrobials belonging to classes considered important in human medicine should be closely monitored so as to be able to detect emergence of antimicrobial resistance in time to allow corrective strategies to be implemented as part of an efficient post-licensing review.
9. Post -approval surveillance of antimicrobial resistance should include identification of the appropriate bacteria and methods of collection. Relevant antimicrobials to be included in such post-approval surveillance programmes should be guided by a risk -based priority list under the direction of the relevant authority. The methods and data should be made publicly available. Such surveillance may be carried out with the participation of the veterinary pharmaceutical industry.
10. Epidemiological and/or experimental investigations to identify risk factors may be needed if resistance increases above levels of concern, and proportionally incremental mitigation strategies**, such as education, infection control, labeling changes, changes in dosing and duration of use, should then be implemented. If, and when the ongoing assessment of the risk demonstrates it to be unacceptable, withdrawal of an antimicrobial for veterinary use from the market should be considered.
11. Relevant authorities should ensure that all antimicrobials for disease control in animals are classified as prescription-only medicines unless, under exceptional circumstances, veterinary advice is not available and alternative means of disease control must be facilitated. Under such exceptional circumstances, relevant authorities should take steps to ensure that veterinary advice becomes available in the future.
12. Antimicrobial products, including generic products, should be manufactured in accordance with the current good manufacturing practices (GMP) and following the specifications laid out in the licensing application by the relevant authorities. Relevant authorities that lack the necessary resources to evaluate product applications should provide for alternative mechanisms, such as third party certification, to ensure safe, effective and quality products are licensed for use.
13. Enforcement policies should be designed to ensure compliance with laws and regulations pertaining to the authorization, distribution and sale, and use of antimicrobials. They should aim at preventing the illicit manufacture, importation, and sale of antimicrobials, and controlling their distribution and use.
14. Special attention should be paid to the distribution and sale of counterfeit, sub-potent and misbranded veterinary antimicrobials. Enforcement action should be taken to stop such distribution and sale by relevant authorities, in coordination with the exporting country, if appropriate.
15. Relevant authorities should ensure that all antimicrobials for animal use should be supplied only through authorized outlets, such as pharmacies on veterinary prescription, veterinary practices and feed mills, in the case of materials used in animal feeding stuffs.
16. If sufficient evidence exists that profit from the sale of antimicrobials negatively impacts on prescribing practices, appropriate countermeasures should be taken to ensure prudent use.
17. The advertising and promotion of animal health products should comply with national guidelines and codes of practice. Commercial promotion of prescription-only antimicrobial products should be directed only to veterinary professionals.
Antimicrobial growth promoters
18. Use of antimicrobial growth promoters that belong to classes of antimicrobial agents used (or submitted for approval) in humans and animals should be terminated or rapidly phased-out in the absence of risk-based evaluations. The termination or phasing-out should be accomplished preferably by voluntary programmes of food animal producers, but by legislation if necessary.
19. Risk-based evaluations of all antimicrobial growth promoters should be continued. Characterization of the risk may include consideration of the present and potential future importance of the drug to human medicine, its selection of resistance, the potential exposure to humans from resistant bacteria from food animals, as well as other appropriate scientific factors.
SURVEILLANCE OF ANTIMICROBIAL RESISTANCE AND ANTIMICROBIAL USAGE
Data generated from the surveillance of antimicrobial resistance and antimicrobial usage should play a key role in the development of national policies for the containment of antimicrobial resistance. These data are also essential in the pre- and post-licensing process and in the development of treatment guidelines for veterinary use.
Surveillance of antimicrobial resistance
21. Programmes to monitor antimicrobial resistance in animal pathogens, zoonotic agents (for example, Salmonella spp. and Campylobacter spp.), and bacteria known to be indicators of antimicrobial resistance (for example, Escherichia coli and Enterococcus faecium) should be implemented on bacteria from animals, food of animal origin and humans. Veterinarians, medical doctors, authorities and other stakeholders should be kept regularly informed about the surveillance results and trends. Antimicrobial susceptibility testing should be performed according to standardized methods using appropriate quality control, and be reported quantitatively to allow comparison of results.
Surveillance of antimicrobial usage
22. Relevant authorities should establish systems to determine the amounts of antimicrobials given to food animals.
23. Information on the amounts of antimicrobials given to food animals should be made publicly available at regular intervals, be compared to data from surveillance programmes on antimicrobial resistance, and be structured to permit further epidemiological analyses.
PRUDENT USE OF ANTIMICROBIALS
Guidelines on prudent use
24. The strategic aim of policies expressed in guidelines should be to provide advice on optimal therapeutic effect and/or protection of animals at risk and on the control of antimicrobial resistance in animal and zoonotic bacteria.
25. Guidelines on the prudent use of antimicrobials in animals should be readily accessible, developed with multidisciplinary involvement, subject to peer review, compatible with existing regulations, and should be evaluated and revised at regular intervals.
- Locally-derived species-specific treatment guidelines should include a list of antimicrobials for conditions commonly presenting in clinical practice and offer a rational treatment choice based on scientific data and knowledge, the disease and resistance situation, practical experience and human health concerns. If several antimicrobials can be used, guidelines should make recommendations on different antimicrobials to be used. However, the clinical experience and judgement of the practitioner should determine the final choice.
Responsibilities of veterinarians and/or producers
27. For each treated animal or group of animals a health record should be kept to support the choice of empirical therapy. The record should include:
- data on antimicrobial use;
- previous antimicrobial susceptibility test results; and/or
- previous treatment outcomes.
- Veterinarians should continuously evaluate their prescribing practices. This would be based on information such as the main indications and types of antimicrobials used in different animal species and be evaluated in relation to available data on antimicrobial resistance and current use guidelines.
29. Veterinarians should prescribe antimicrobials only for animals under their direct care. Veterinarians are expected to have examined clinically affected animals, or to be familiar with production practices on the farm and to have developed a written treatment protocol, prior to prescribing medication.
30. Antimicrobials should be prescribed only when indicated, using antibiotics directed against the causative agent/s, given in optimal dosage, dosage intervals and length of treatment to ensure maximum concordance with the treatment regimen.
31. It is the responsibility of the producers to ensure that production systems promote animal health and welfare. Antimicrobial usage, if necessary, should always be a part of, not a replacement for, an integrated animal health programme. Such a programme is likely to involve hygiene and disinfection procedures, biosecurity measures, management alterations, changes in stocking rate, vaccination and other relevant components.
32. Veterinarians together with producers should be jointly responsible for the health of animals on the farm. Veterinarians and producers should agree on policies and protocols on preventive strategies, health and treatment programmes and veterinary involvement in ongoing animal health management. These policies and protocols should comply with prudent use principles, good farming practice, and quality assurance programmes.
PROPHYLACTIC USE OF ANTIMICROBIALS
Use of antimicrobials for prevention of disease can only be justified where it can be shown that a particular disease is present on the premises or is likely to occur. The routine prophylactic use of antimicrobials should never be a substitute for good animal health management.
34. Prophylactic use of antimicrobials in control programmes should be regularly assessed for effectiveness and whether use can be reduced or stopped. Efforts to prevent disease should continuously be in place aimed at reducing the need for the prophylactic use of antimicrobials.
EDUCATION AND TRAINING
Veterinary undergraduate, postgraduate and continuing education should be evaluated to ensure that preventive medicine, prudent antimicrobial use and antimicrobial resistance are given high priority.
36. Ongoing education strategies should be developed by entities such as professional associations, relevant authorities, appropriate international organizations and/or educational institutions to provide relevant professional bodies and stakeholders with appropriately targeted information about infections, the role and benefits of prudent antimicrobial use and the risks of inappropriate use. All relevant stakeholders including the veterinary pharmaceutical industry and public health sectors should be encouraged to support this effort.
- Continuous evaluation of the effectiveness of educational strategies for prudent use should be conducted.
38. Education strategies emphasizing the importance and benefits of prudent use principles must be developed and implemented to provide relevant information on antimicrobial resistance for producers and stakeholders. Emphasis must also be given to the importance of optimizing animal health through implementation of disease prevention programmes and good management practices.
39. The public should be informed of the human health aspects of antimicrobial use in food animals, so that they can support efforts to control antimicrobial resistance.
Stakeholders should identify research priorities to address public health issues of antimicrobial resistance from antimicrobial use in food animals. Governments, universities, research foundations and industry should give high priority to supporting research in these areas.
Source: World Health Organization (WHO)