Terrestrial Animal Health Code
Terrestrial Animal Health Code |
Responsible and prudent use of antimicrobial agents in veterinary medicine
Purpose and scope
This document provides guidance for the responsible and prudent use of antimicrobial agents in veterinary medicine for treatment, control and prevention of diseases in food- and non-food-producing animals, with the aim of protecting both animal and human health as well as minimising and containing antimicrobial resistance risks in the relevant animal environment, as part of a One Health approach.
It defines the respective responsibilities of the Competent Authorities and stakeholders such as the veterinary pharmaceutical industry, veterinarians, animal feed manufacturers, distributors, and animal breeders, owners and keepers, who are involved in any or all of the following activities: regulatory approval, production, control, importation, exportation, sales, advertising, distribution, prescription and use of veterinary medicinal products containing antimicrobial agents.
Responsible and prudent use is determined by taking into account the importance of the antimicrobial agent to veterinary and human medicine, the risk of development of antimicrobial resistance, the specifications detailed in the relevant regulatory approval and the indications for use, including off-label use, when antimicrobial agents are administered to animals. It is part of good veterinary practices. All measures to keep animals healthy, such as preventing infectious diseases through vaccination, biosecurity, good agricultural practices and good animal husbandry practices and adequate nutrition contribute to a decreased need of using antimicrobial agents in animals, thus reducing the risk for development and spread of antimicrobial resistance.
Activities associated with the responsible and prudent use of antimicrobial agents should involve all relevant stakeholders.
Coordination of these activities at the national or regional level is recommended and may support the implementation of targeted actions by the stakeholders involved and enable clear and transparent communications.
Objectives of responsible and prudent use
The objectives of responsible and prudent veterinary medical use of antimicrobial agents are to:
preserve the effectiveness of antimicrobial agents used in veterinary and human medicine and their safety in animals;
comply with the ethical obligation and economic need to keep animals in good health;
prevent or reduce transfer of resistant microorganisms or resistance determinants within animal populations, between animals, humans, and the environment;
protect human health by ensuring the safety of food of animal origin with respect to residues of antimicrobial agents.
In order to achieve the objectives of responsible and prudent veterinary medical use of antimicrobial agents, a range of measures intended to improve animal health and animal welfare while preventing or reducing the selection, emergence and spread of antimicrobial resistant microorganisms and resistance determinants in animals, humans and environment should be implemented. These measures include promotion of good animal husbandry practices, hygiene procedures, biosecurity, vaccination strategies, access to laboratory testing, and alternatives to the use of antimicrobials, which can help to minimise the need for antimicrobial use in animals.
Responsibilities of the Competent Authorities
National Action Plan for Antimicrobial Resistance
The Competent Authorities should design and oversee the implementation of the relevant part of their National Action Plan considering the findings of the situational analysis of the country, the objectives of the WOAH, WHO, FAO and UNEP Global Action Plan (GAP) for Antimicrobial Resistance and existing guidance for developing National Action Plans for antimicrobial resistance. The Competent Authorities in cooperation with animal health, plant health, environment and public health professionals, and other relevant stakeholders should adopt a One Health approach to promote the responsible and prudent use of antimicrobial agents as an element of a national strategy to minimise and contain antimicrobial resistance. Furthermore, the Competent Authorities should allocate budgetary resources for the design and implementation of the relevant part of their National Action Plan including communication strategies and professional training programmes. The Competent Authorities should also conduct regular monitoring and evaluation of the National Action Plan.
National Action Plans should incorporate and inform on best management practices, including disease prevention and control measures, implementation of biosecurity and development of animal health programmes to reduce the burden of animal disease thereby reducing the need for antimicrobial use. As part of National Action Plans for antimicrobial resistance, the Competent Authorities should ensure that surveillance for antimicrobial use and antimicrobial resistance in the animal health sector are in place and should work closely together with human, plant and environmental sectors on the harmonisation, analysis and integration of surveillance across sectors. The Competent Authorities should implement a programme in accordance with Chapters 1.4. and 6.8.
National Action Plans should include recommendations to relevant professional organisations to develop evidence-based species or sector-specific antimicrobial use guidelines.
Regulatory approval
The Competent Authority is responsible for granting relevant regulatory approval which should be done in accordance with the provisions of the Terrestrial Code. The Competent Authority has a significant role in specifying the terms of this approval and in providing the appropriate information to veterinarians and all other relevant stakeholders.
The Competent Authority should establish and implement efficient statutory registration procedures that evaluate the quality, safety and efficacy and post-marketing surveillance programmes for veterinary medicinal products containing antimicrobial agents. According to Article 3.2.2., the Competent Authority should be free from any commercial, financial, hierarchical, political or other pressures which might influence its judgement or decisions.
Member Countries lacking the necessary resources to implement an efficient registration procedure for veterinary medicinal products containing antimicrobial agents, and which are importing them, should undertake the following measures:
evaluate the effectiveness of administrative controls on the import of these veterinary medicinal products;
evaluate the validity of the registration procedures of the exporting or manufacturing country as appropriate;
develop the necessary technical co-operation with an experienced Competent Authority to check the quality of imported veterinary medicinal products as well as the validity of the recommended conditions of use.
The Competent Authority of importing countries should request the veterinary pharmaceutical industry to provide certificates of quality prepared by the Competent Authority of the exporting or manufacturing country as appropriate.
Regulatory approval is granted for veterinary medical use, as defined in Article 6.9.2., on the basis of the data submitted by a pharmaceutical company or other applicant and only if the criteria of quality, safety and efficacy are met.
The Competent Authority is encouraged to consult and apply, as appropriate, the guidelines based on the technical requirements for veterinary product registration established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
An evaluation of the risks and benefits to both animals and humans resulting from the use of antimicrobial agents in animals should be carried out. The evaluation may focus on each individual antimicrobial agent; the findings from one agent should not be generalised to the antimicrobial class to which the particular active ingredient belongs. Guidance on use should be provided for all target species, route of administration, dosage regimen (dose, dosing interval and duration of the administration), and withdrawal period as relevant.
The Competent Authority should implement timely regulatory approval processes for new antimicrobial agents or other options, including alternatives to the use of antimicrobials, in order to address specific needs for the treatment of animal diseases and should take into account recommendations included in the WOAH List of Antimicrobials of Veterinary Importance.
Quality of antimicrobial agents and veterinary medicinal products containing antimicrobial agents
The Competent Authority should make sure that the quality of the veterinary medicinal products was determined by the applicant in accordance with national and international guidance to ensure that:
the specifications of antimicrobial agents used as active ingredients comply with the provisions of registration documentations (such as monographs) approved by the relevant Competent Authority;
the quality of antimicrobial agents in the marketed dosage forms is maintained until the expiry date, established under the recommended storage conditions;
antimicrobial agents are stable and compatible when mixed with feed or water;
all antimicrobial agents and the veterinary medicinal products containing them are manufactured to the appropriate quality and in compliance with the provisions of good manufacturing practices.
Assessment of efficacy
The Competent Authority should conduct an assessment of the efficacy based on data provided in the relevant regulatory approval application submitted by the applicant to enable marketing:
Preclinical trials
Preclinical trials should:
establish the spectrum of activity of antimicrobial agents against relevant pathogenic agents and non-pathogenic agents (commensals);
assess the capacity of the antimicrobial agents to select for resistance in vitro and in vivo, taking into consideration intrinsically resistant strains and strains with acquired resistance;
establish an appropriate dosage regimen and route of administration necessary to ensure the efficacy of the antimicrobial agents and limit the selection of antimicrobial resistance. Pharmacokinetic and pharmacodynamic data and models can assist in this appraisal. Such data together with clinical data could be used by independent experts to establish clinical breakpoints per animal species, antimicrobial agent and pathogen combination.
The activity of antimicrobial agents towards the targeted microorganism should be established by pharmacodynamic investigations. The following characteristics should be taken into account, as appropriate:
spectrum of activity and mode of action;
minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) against recent isolates;
time-kill kinetics;
time-dependent or concentration-dependent activity, or co-dependency;
activity and concentration at the site of infection.
The dosage regimens allowing maintenance of effective antimicrobial concentrations should be informed by pharmacokinetic and pharmacodynamics investigations and should take into account:
any potential routes of administration proposed by the applicant;
absorption, distribution, metabolism and elimination, and concentration at the site of infection.
Further dose determination studies may be conducted to examine the microbiological and clinical response to several dose levels or dosing intervals.
Any proposed use of combinations of antimicrobial agents should be scientifically supported.
Clinical trials
Clinical trials in the target animal species should be performed to confirm the validity of the claimed indications and dosage regimens established during the preclinical phase. The following criteria should be taken into account:
diversity of the clinical cases encountered when performing multi-centre trials;
compliance of protocols with good clinical practice;
eligibility of studied clinical cases, based on appropriate criteria of clinical and bacteriological diagnoses;
parameters for qualitatively and quantitatively assessing the efficacy of the treatment.
Assessment of the potential of antimicrobial agents to select for resistance
Other studies may be requested in support of the assessment of the potential of antimicrobial agents to select for resistance. The applicant for regulatory approval should, where possible, supply data derived in target animal species under the intended conditions of use.
For this assessment the following may be considered:
the concentration of active antimicrobial agents and, where appropriate, active metabolites in the gut of the animal (where the majority of pathogenic and commensal bacteria reside) at the defined dosage level;
the antimicrobial activity of the antimicrobial agents and metabolites in the intestinal environment;
the pathway for human exposure to antimicrobial resistant microorganisms, antimicrobial resistance determinants and antimicrobial residues in the relevant animal environment;
the presence of and potential for co-selection, co-resistance and cross-resistance;
the baseline level of resistance, including intrinsic and acquired resistance, in the pathogenic, commensal and food-borne bacteria of human health relevance in both animals and humans.
Assessment of the impact on the relevant animal environment
The Competent Authority should consider the results of an antimicrobial resistance environmental risk assessment in accordance with Chapter 6.11. For both food- and non-food producing animals the following risk factors should be taken into consideration as appropriate: reuse of wastewater for irrigation, use of manure, other waste-based fertilisers for soil fertilisation, transfer of antimicrobial resistant microorganisms and determinants in veterinary practice. When a significant antimicrobial resistance risk is determined the need for monitoring and proportionate risk management measures should be discussed.
Establishment of acceptable daily intake (ADI), maximum residue limit (MRL) and withdrawal periods in food-producing animals
The establishment of an ADI for each antimicrobial agent, and an MRL for each animal-derived food, should be undertaken before a veterinary medicinal product containing it is granted regulatory approval.
When setting the ADI and MRL for an antimicrobial agent, the safety evaluation should also include the potential microbiological effects on the intestinal microbiota of humans to derive ADI.
For all veterinary medicinal products containing antimicrobial agents for use in food-producing animals, withdrawal periods should be established for each animal species in order to ensure compliance with the MRLs, taking into account:
the MRLs established for the antimicrobial agent in the target animal edible tissues;
the composition of the product and the pharmaceutical form;
the dosage regimen;
the route of administration.
Methods used for regulatory testing of residues in food should be described and based on the established marker residues.
Establishment of a summary of product characteristics or equivalent for each veterinary medicinal product containing antimicrobial agents
The Competent Authority should ensure that the Summary of Product Characteristics (SPC) or equivalent, the package insert, and labelling includes the information necessary for the appropriate use of veterinary medicinal products containing antimicrobial agents. The SPC or equivalent summary should contain the following items as appropriate:
name of the veterinary medicinal product;
active ingredient and class;
pharmaceutical form;
quantitative composition;
pharmacological properties;
any potential adverse effects;
target animal species and, as appropriate, age or production category;
therapeutic indications;
target microorganisms;
dosage regimen (i.e. dose, frequency of dosing, and route and duration of administration);
withdrawal periods;
incompatibilities and interactions;
storage conditions and shelf-life;
operator safety;
particular precautions before use;
precautions for the protection of the environment;
use during pregnancy, lactation or lay;
particular precautions for the proper disposal of unused or expired products;
information on conditions of use relevant to minimise the development of resistance;
contraindications;
known signs of overdosage and information about its treatment.
Post-marketing antimicrobial resistance surveillance
The Competent Authority should assess the information collected through existing pharmacovigilance and surveillance programmes, including reporting of lack of response, and any other relevant scientific data. These information sources should form part of the comprehensive strategy to detect and minimise antimicrobial resistance.
In addition, specific surveillance should be considered to assess the impact of the use of a specific veterinary medicinal product, where scientific evidence indicates a specific risk and may be implemented after the granting of the relevant regulatory approval. The surveillance programme should evaluate not only resistance in target animal pathogens, but also in foodborne and other relevant zoonotic pathogens, and commensals if relevant and possible. This will also contribute to general epidemiological surveillance of antimicrobial resistance.
Distribution and administration of antimicrobial agents or veterinary medicinal products containing antimicrobial agents
The Competent Authority should ensure that all the antimicrobial agents and veterinary medicinal products containing antimicrobial agents used in animals including through feed and water are:
supplied only through licensed or authorised distribution systems;
not illegal, substandard, falsified medicines or unapproved formulations and that these are prevented from entering distribution systems;
prescribed by a veterinarian or other suitably trained person authorised to prescribe veterinary medicinal products containing antimicrobial agents in accordance with the national legislation;
administered to animals by a veterinarian or under the supervision or by direction of a veterinarian, by other suitably trained persons, animal breeders, owners or keepers as appropriate.
The Competent Authority should encourage the availability of authorised products on the market and in collaboration with the veterinary pharmaceutical industry follow-up any potential drug shortages.
The Competent Authority should develop and implement effective procedures for the safe collection and disposal or destruction of unused or expired veterinary medicinal products containing antimicrobial agents. Their labels should have appropriate instructions for disposal and destruction.
Control of advertising
All advertising of antimicrobial agents should be compatible with the principles of responsible and prudent use and should be controlled by codes of advertising standards. The Competent Authority should ensure that:
the advertising of these products complies with the regulatory approval granted, in particular regarding the content of the summary of product characteristics or equivalent;
advertising is restricted to a veterinarian or other suitably trained person authorised to prescribe veterinary medicinal products containing antimicrobial agents, or to persons permitted to supply veterinary medicinal products in accordance with the national legislation; and
their promotion is done in a manner consistent with specific regulatory recommendations for the product.
Establishment of clinical breakpoints
The Competent Authority should encourage and support the development of clinical breakpoints for each bacteria-antimicrobial-animal species combination to interpret the results of susceptibility tests. Those clinical breakpoints should be established in accordance with the Terrestrial Manual.
Training related to the use of antimicrobial agents and antimicrobial resistance
The Competent Authority should take a key role in promoting targeted training for responsible and prudent use of antimicrobials and on antimicrobial resistance. The target audiences for the training on the use of antimicrobial agents should include all the relevant stakeholders and organisations, such as the veterinary pharmaceutical industry, veterinary and paraprofessional education establishments, research institutes, veterinary professional and paraprofessional organisations and other approved users such as breeders, owners and keepers of food-producing animals and manufacturers of medicated animal feed. The training may include:
the ability of antimicrobial agents to select for resistant microorganisms in animals and the importance of that resistance to public and animal health and the relevant animal environment;
the need to observe responsible and prudent use principles for the use of antimicrobial agents in animal husbandry in agreement with the provisions of the regulatory approval, national and international guidelines and recommendations from the WOAH List of Antimicrobial Agents of Veterinary Importance;
information on the appropriate storage conditions before and during use and proper disposal of unused or expired veterinary medicinal products;
training in existing and new methodologies for target pathogen identification, susceptibility testing, molecular detection of resistance and risk assessment models, understanding methods and results of antimicrobial susceptibility testing and molecular analysis and their use in risk assessment;
interpretation of relevant risk assessment outputs of antimicrobial resistance derived from the use of veterinary medicinal products containing antimicrobial agents in animals and how to use these outputs to inform the development of risk management and risk communication strategies;
the collection and reporting of antimicrobial resistance and antimicrobial use data to the Competent Authority to complement existing national and international surveillance programmes;
information on disease prevention, management and mitigation strategies that can contribute to reducing the need to use antimicrobial agents in animals.
Monitoring of antimicrobial use
In accordance with Chapter 6.9., the Competent Authority should collate data on antimicrobial use in a harmonised manner to improve the understanding of the extent and trends of antimicrobial use and antimicrobial resistance in animal populations at national level and identify areas for further research. The data collected on antimicrobial use at country level should:
give an indication of the trends in the use of antimicrobial agents in animals over time and potential associations with antimicrobial resistance in animals;
help in the interpretation of antimicrobial resistance surveillance data and assist in responding to problems of antimicrobial resistance in a precise and targeted way;
assist in risk management to evaluate the effectiveness of efforts and mitigation strategies;
inform risk communication strategies;
foster improved antimicrobial stewardship, ensuring continued availability of safe and effective antimicrobial agents for both animal and human health.
The Competent Authority should provide the data to the 'Animal Antimicrobial Use Global database of the World Organisation for Animal Health' on a yearly basis.
Knowledge gaps and research
The Competent Authority should encourage coordination of public- and private-funded research, including in the following areas:
improve the knowledge about the mechanisms of action, pharmacokinetics and pharmacodynamics of antimicrobial agents to optimize the dosage regimens for veterinary medical use and their effectiveness;
improve the knowledge about the mechanisms of selection, co-selection, emergence and transmission of resistance determinants and resistant microorganisms in animal populations, and between animals, humans and the relevant animal environment, including along the food chain;
develop practical models for applying the concept of risk analysis to assess the animal and public health concerns linked to the development of antimicrobial resistance in animals and animal-derived foods;
further develop protocols to predict, during the regulatory approval process, the impact of the proposed use of the antimicrobial agents in animals on the rate and extent of antimicrobial resistance development and spread to animals, humans, plants and the relevant animal environment, following a One Health approach;
assess the primary drivers leading to use of antimicrobial agents in animals, and the effectiveness of different interventions to change behaviour and reduce the need to use antimicrobial agents in animals;
develop safe and effective alternatives to use of antimicrobial agents, new antimicrobial agents, rapid diagnostics, and vaccines for infectious diseases to reduce the need for antimicrobial use in animals;
improve knowledge on the role of the environment on the persistence of antimicrobial agents, and the emergence, transfer and persistence of antimicrobial resistance determinants and resistant microorganisms in the relevant animal environment.
Competent Authorities should implement appropriate regulatory measures to control the unauthorised manufacture, compounding, importation, advertisement, trade, distribution, storage and use of unlicensed, adulterated and counterfeit veterinary medicinal products containing antimicrobial agents, including bulk active ingredients.
Responsibilities of the veterinary pharmaceutical industry with regards to veterinary medicinal products containing antimicrobial agents
Regulatory approval
The veterinary pharmaceutical industry has responsibilities to:
provide all the information requested by the national Competent Authority as specified in Article 6.10.3.;
guarantee the quality of this information in compliance with the provisions of good manufacturing, laboratory and clinical practices;
implement, and report in a timely manner, a pharmacovigilance programme, and on request, specific surveillance for bacterial susceptibility and resistance data. For the latter, the veterinary pharmaceutical industry should isolate and identify bacteria, and collect relevant data and submit them to the Competent Authority. These data may enable independent experts to establish clinical breakpoints for use in the laboratory to guide antimicrobial therapy.
Marketing and export
For the marketing and export of veterinary medicinal products containing antimicrobial agents:
only licensed and officially approved veterinary medicinal products containing antimicrobial agents should be sold and supplied, and then only through authorised distribution systems;
the veterinary pharmaceutical industry should provide certificates of quality prepared by the Competent Authority of the exporting or manufacturing countries to the importing country;
the veterinary pharmaceutical industry should endeavour to ensure the availability of authorised products and cooperate with the Competent Authority to forecast and avoid any drug shortage;
the veterinary pharmaceutical industry should provide the Competent Authority with the information necessary to evaluate the amount of antimicrobial agents marketed.
Advertising
The veterinary pharmaceutical industry should respect principles of responsible and prudent use and should comply with established codes of advertising practices, including to:
distribute information in compliance with the provisions of the granted approval;
not advertise veterinary medicinal products containing antimicrobial agents directly to the food animal breeder, owner and keeper or to the general public.
Training
The veterinary pharmaceutical industry should participate in training programmes as defined in point 13 of Article 6.10.3.
Research
The veterinary pharmaceutical industry should contribute to research as defined in point 15 of Article 6.10.3.
Responsibilities of wholesale and retail distributors
Distributors should only distribute veterinary medicinal products containing antimicrobial agents in accordance with the national legislation as prescribed by a veterinarian or other suitably trained person authorised to prescribe veterinary medicinal products containing antimicrobial agents. All products should be appropriately labelled.
The recommendations on the responsible and prudent use of veterinary medicinal products containing antimicrobial agents should be reinforced by retail distributors who should keep for an appropriate period detailed sales records of:
date of sale;
name and contact information of the prescriber;
name of user;
name of product;
batch number;
expiration date;
quantity supplied;
copy of prescription;
other information as required by national legislation.
Distributors should also be involved in training programmes on the responsible and prudent use of veterinary medicinal products containing antimicrobial agents, as defined in point 13 of Article 6.10.3.
Responsibilities of veterinarians
The veterinarian’s responsibility is to promote animal health and animal welfare, as well as public health, through antimicrobial stewardship, prevention, detection, diagnosis, control and treatment of animal diseases. The promotion of sound animal husbandry methods, hygiene procedures, biosecurity and vaccination strategies can help to minimise the need for antimicrobial use in animals.
The veterinarian should only prescribe antimicrobial agents for animals under their care. The veterinarian should consider safe and effective alternatives to the use of antimicrobials before prescribing antimicrobial agents.
Some of the responsibilities described in this article may be applicable to veterinary paraprofessionals or other suitably trained persons according to the national legislation.
Pre-requisites for using antimicrobial agents
The responsibilities of veterinarians are to obtain a detailed history and carry out a proper clinical examination of the animal(s), taking appropriate samples for further testing as necessary. If the provisional or definitive diagnosis is a microbial infection, then the veterinarian should:
prescribe, dispense or administer antimicrobial agents only when necessary to treat, control or prevent infectious diseases in animals;
avoid the use of antimicrobial agents to compensate for inadequate animal husbandry practices;
take into consideration the WOAH List of Antimicrobial Agents of Veterinary Importance and follow science-based species or sector-specific antimicrobial use guidelines for responsible and prudent use when available and follow the principles of antimicrobial stewardship;
make an appropriate choice of antimicrobial agent based on clinical experience and available diagnostic laboratory information (pathogenic agent isolation, identification and antimicrobial susceptibility testing);
provide a detailed treatment protocol, including precautions and withdrawal period (if applicable), especially when prescribing extra-label or off-label use;
provide adequate supportive therapy, if appropriate.
Choosing antimicrobial agents
The choice of an effective treatment is based on:
the clinical experience of the veterinarians, their diagnostic insight and therapeutic judgement;
diagnostic laboratory information (pathogenic agent isolation, identification and antimicrobial susceptibility testing);
pharmacodynamic properties of the selected antimicrobial agent, including the activity towards the pathogenic agents involved;
the appropriate dosage regimen (i.e. dose, frequency of dosing, and route and duration of administration);
pharmacokinetics and tissue distribution to ensure that the selected therapeutic agent is effective at the site of infection;
the epidemiological history relevant to the animal or animals being treated, particularly in relation to the antimicrobial resistance profiles of the pathogens involved.
Should a first-line antimicrobial treatment fail or should the disease recur, an investigation should be undertaken to reassess the circumstances including reviewing the diagnosis, conducting additional diagnostic testing as needed, and then formulate and implement a new treatment plan, which may or may not include another antimicrobial agent.
In particular situations, a veterinarian may treat animals empirically, before an accurate diagnosis and antimicrobial susceptibility testing results are available, to prevent the development of clinical disease.
Combinations of antimicrobial agents may be used to increase effectiveness, but only when scientifically supported.
When prescribing, dispensing or administering a veterinary medicinal product containing antimicrobial agents intended for veterinary medical use to an individual or a group of animals to treat, control or prevent an infectious disease as defined in Chapter 6.9., the veterinarian should give specific consideration to their categorisation in the WOAH List of Antimicrobial Agents of Veterinary Importance or national lists. Preference should be given to the least important antimicrobial agent as categorised by WHO that is appropriate for use.
Appropriate veterinary medical use of the selected product containing antimicrobial agents
The prescription of a veterinary medicinal product containing antimicrobial agents should indicate the dosage regimen, the withdrawal period where applicable, and when considering group treatments, the total amount of veterinary medicinal products containing antimicrobial agents to be provided, which will depend on the dosage, duration of treatment, and the number of animals to be treated.
The veterinarian should ensure that instructions for the administration of the product are clearly explained and understood by breeders, owners, keepers or any other person responsible for administering the product.
The extra-label or off-label use of a veterinary medicinal product and of a compounded product containing antimicrobial agents may be permitted in certain appropriate circumstances and should be for treatment, control and prevention of diseases, in agreement with the national legislation in force including the withdrawal period, as applicable. It is the veterinarian's responsibility to define the conditions of responsible and prudent use in such a case including the dosage regimen, the route of administration and the withdrawal period.
The use of compounded veterinary medicinal products containing antimicrobial agents and extra-label or off-label use of registered veterinary medicinal products containing antimicrobial agents should be limited to circumstances where an appropriate registered product is not available and should take into account recommendations provided in the WOAH List of Antimicrobial Agents of Veterinary Importance.
Recording of data
Records of veterinary medicinal products containing antimicrobial agents should be kept in conformity with the national legislation. Records should include the following, as appropriate:
commercial name of the veterinary medicinal products;
name of the antimicrobial agents in the veterinary medicinal products;
quantities used in animals or supplied to each establishment or animal breeder, owner or keeper;
route of administration;
animal species;
number of animals treated;
clinical condition treated;
treatment schedules including animal identification and length of the withdrawal period;
antimicrobial susceptibility data, including laboratory records of pathogenic agent isolation, identification and susceptibility testing obtained from isolates;
comments concerning the response of the animal or animals to treatment;
the investigation of adverse reactions associated with antimicrobial treatment, including lack of effectiveness. Suspected adverse reactions should be reported to the holder of the regulatory approval or appropriate Competent Authority in accordance with national legislation.
Veterinarians should also periodically review farm records on the use of veterinary medicinal products containing antimicrobial agents to ensure compliance with their directions or prescriptions and use these records to evaluate the effectiveness of treatments.
Labelling
All veterinary medicinal products supplied by a veterinarian should be labelled in accordance with the national legislation.
Training and continuing professional development
Veterinary professional and paraprofessional organisations should participate in the training programmes as defined in point 13 of Article 6.10.3. It is recommended that veterinary professional and paraprofessional organisations develop for their members species-specific clinical practice recommendations on the responsible and prudent use of veterinary medicinal products containing antimicrobial agents.
Responsibilities of animal feed manufacturers
The manufacturing of medicated feed containing antimicrobial agents and its supply to breeders, owners and keepers of food-producing animals by animal feed manufacturers should be allowed only on the prescription of a veterinarian. Alternatively, such medicated feed may be prescribed by other suitably trained persons authorised to prescribe veterinary medicinal products containing antimicrobial agents in accordance with the national legislation. Animal feed manufacturers preparing medicated feed should do so following rules put in place by the Competent Authority in accordance with the national legislation. All medicated feed and medicated premixes should be appropriately labelled.
Keep detailed records for medicated feed and premixes for a suitable period of time according to national legislation.
Use only approved sources of pharmaceutical products: Animal feed manufacturers preparing medicated feed should ensure that only approved sources of medications are added to feed at a level, and for a species and purpose as permitted by the medicated premix label or a veterinary prescription.
Ensure appropriate labelling with product identification, direction for use and withdrawal period: animal feed manufacturers preparing medicated feed should ensure that medicated animal feed are labelled with the appropriate information (e.g., level of medication, approved claim, target species, directions for use, warning, cautions) to ensure effective and safe use by the breeder, owner or keeper.
Implement appropriate production practices to prevent contamination of other feed: animal feed manufacturers preparing medicated feed should implement good manufacturing practices to avoid unnecessary carry over and cross contamination of unmedicated feed.
Feed manufacturers should participate in training programmes as defined in point 13 of Article 6.10.3.
Responsibilities of breeders, owners and keepers of food-producing animals
Breeders, owners and keepers of food-producing animals with the assistance and guidance of a veterinarian, are responsible for implementing animal health and animal welfare programmes, including biosecurity and good animal husbandry practices on their farms in order to reduce the need for the use of antimicrobial agents in animals, and to promote animal health and food safety.
Breeders, owners and keepers of food-producing animals should:
draw up a health plan with the attending veterinarian that outlines preventive and control measures;
implement on-farm biosecurity and take appropriate hygiene precautions;
isolate sick animals, when appropriate, to avoid the transfer of pathogenic agents;
dispose of dead or dying animals promptly under conditions approved by the Competent Authorities;
use veterinary medicinal products containing antimicrobial agents only on the prescription and under the supervision of a veterinarian, veterinary paraprofessional or other suitably trained person in accordance with the national legislation;
use veterinary medicinal products containing antimicrobial agents in accordance with product label instructions, including storage conditions, and the instructions of the prescribing veterinarian; extra-label/off-label use of veterinary medicinal products containing antimicrobial agents should be in line with the relevant national legislation and the instructions of the prescribing veterinarian;
comply with the recommended withdrawal periods to ensure that residue levels in animal-derived food do not present a risk for the consumer;
use veterinary medicinal products containing antimicrobial agents within the expiry date and dispose of unused and expired surplus veterinary medicinal products containing antimicrobial agents under conditions safe for the relevant animal environment according to the summary of product characteristics (SPC) or equivalent, or relevant national legislation;
ensure that only medicated premixes containing antimicrobial agents from authorised sources are added to feed at a dose and duration appropriate for the target animal species and purpose of use as permitted by the medicated premix label or a veterinary prescription when preparing medicated feed on-farm;
maintain all the laboratory records of bacteriological and susceptibility tests; these data should be made available to the veterinarian responsible for treating the animals;
keep adequate records of all veterinary medicinal products containing antimicrobial agents used, including the following:
name of the product or the active pharmaceutical ingredient and batch number;
name and contact details of prescriber and the supplier;
date of administration;
identification of the animal or group of animals, and the number of animals to which the antimicrobial agent was administered;
disease treated;
dose regimen (including dose, dosing interval and duration of treatment);
withdrawal periods including the end-date of the withdrawal periods;
inform the responsible veterinarian of recurrent disease problems.
Training
Food animal breeders, owners and keepers should participate in the training programmes as defined in point 13 of Article 6.10.3.
It is recommended that food animal organisations work in cooperation with the veterinary professional organisations to implement existing guidelines for the responsible and prudent use of veterinary medicinal products containing antimicrobial agents.
Responsibilities of breeders, owners and keepers of non-food producing animals
Animal breeders, owners and keepers, with the assistance and guidance of a veterinarian, are responsible for the health and welfare of their animals and should:
implement the wellness plans and preventative health plans recommended by their veterinarian;
strictly follow their veterinarian's recommendations and ensure that if any, the administration of veterinary medicinal products containing antimicrobial agents follows the veterinary prescription;
avoid administering over the counter human and veterinary antimicrobial agents to their animals;
not administer remaining or expired human and veterinary antimicrobial agents to their animals;
inform their veterinarian or veterinary paraprofessional of the administration of any additional medicinal products than those prescribed by the veterinarian during the consultation;
inform their veterinarian of any observed lack of effectiveness or adverse effect;
ensure that only antimicrobial agents from authorised sources are administered in accordance with national legislation.
nb: first adopted in 2003; most recent update adopted in 2024.
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