Aquatic Animal Health Code
Principles for responsible and prudent use of antimicrobial agents in aquatic animals
These principles provide guidance for the responsible and prudent use of antimicrobial agents in aquatic animals, with the aim of protecting both animal and human health. The Competent Authorities responsible for the registration and marketing authorisation of products and the control of all organisations involved in the production, distribution and use of antimicrobial agents have specific obligations.
Objectives of responsible and prudent use
Responsible and prudent use includes a set of practical measures and recommendations intended to reduce the risk associated with the selection and dissemination of antimicrobial resistant microorganisms and antimicrobial resistance determinants in aquatic animal production to:
maintain the efficacy of antimicrobial agents both for veterinary and human medicine and to ensure the rational use of antimicrobials in aquatic animals with the purpose of optimising both their efficacy and safety;
comply with the ethical obligation and economic need to keep aquatic animals in good health;
prevent or reduce the transfer of both resistant microorganisms and resistance determinants from aquatic animals to humans and terrestrial animals;
prevent antimicrobial residues that exceed the established maximum residue limit (MRL) occurring in the food.
Pharmacovigilance of antimicrobial agent: means the detection and investigation of the effects of the use of these products, mainly aimed at safety and efficacy in aquatic animals and safety in people exposed to the products.
Responsibilities of Competent Authorities
The Competent Authorities responsible for granting marketing authorisation for antimicrobial agents have a significant role in specifying the terms of the authorisation and in providing the appropriate information to the veterinarian or other aquatic animal health professional through product labelling and/or by other means, in support of prudent use of antimicrobial agents in aquatic animals.
Competent Authorities in cooperation with animal and public health professionals should adopt a proactive approach to promote prudent use of antimicrobial agents in aquatic animals as an element of a comprehensive strategy for the containment of antimicrobial resistance.
Elements of a comprehensive strategy should include good animal husbandry practices, vaccination policies and development of animal health care at the farm level, and consultation with a veterinarian or other aquatic animal health professional, all of which should contribute to reduction of the prevalence of animal disease requiring antimicrobial treatment.
Competent Authorities should expeditiously grant marketing authorisations when criteria of quality, efficacy and safety are met.
The examination of marketing authorisation applications should include an assessment of the risks to animals, humans and the environment resulting from the use of antimicrobial agents in aquatic animals. The evaluation should focus on each individual antimicrobial agent and take into consideration the class of antimicrobials to which the particular active substance belongs. The safety evaluation should include consideration of the potential impact of the proposed use in aquatic animals on human health, including the human health impact of antimicrobial resistance developing in microorganisms found in aquatic animals. An assessment of the impact of the proposed use on the environment should be conducted.
Competent Authorities should aim to ensure that advertising of antimicrobial agents complies with relevant legislation and marketing authorisations granted and discourage direct advertising other than to those legally entitled to prescribe the antimicrobial agent.
Information collected through pharmacovigilance programmes, including on lack of efficacy, should form part of the Competent Authority’s comprehensive strategy to minimise antimicrobial resistance.
Competent Authorities should disseminate, to veterinarians or other aquatic animal health professionals, information on trends in antimicrobial resistance collected during surveillance programmes and should monitor the performance of susceptibility testing laboratories.
Responsibilities of the veterinary pharmaceutical industry
The veterinary pharmaceutical industry has responsibilities for providing information requested by Competent Authorities on the quality, efficacy and safety of antimicrobial agents. The responsibilities of the veterinary pharmaceutical industry cover pre- and post- marketing phases, including manufacturing, sale, importation, labelling, advertising and pharmacovigilance.
The veterinary pharmaceutical industry has the responsibility to provide the Competent Authority with the information necessary to evaluate the amount of antimicrobial agents marketed. The veterinary pharmaceutical industry should ensure that the advertising of antimicrobial agents directly to the aquatic animal producer is discouraged.
Responsibilities of wholesale and retail distributors
Distributors should ensure that their activities are in compliance with the relevant legislation.
Distributors should ensure that information for the appropriate use and disposal of the antimicrobial agent accompany all distributed products and should also be responsible for maintaining and disposing of the product in accordance with the manufacturer recommendations.
Responsibilities of veterinarians and other aquatic animal health professionals
Responsibilities of veterinarians or other aquatic animal health professionals include identifying, preventing and treating aquatic animaldiseases, as well as the promotion of sound animal husbandry methods, hygiene procedures, vaccination and other alternative strategies to minimise the need for antimicrobial use in aquatic animals.
Veterinarians or other aquatic animal health professionals authorised to prescribe veterinary medicines should only prescribe, dispense or administer a specific course of treatment with an antimicrobial agent for aquatic animals under their care.
The responsibilities of veterinarians or other aquatic animal health professionals are to carry out a thorough clinical assessment of the aquatic animal(s), including as appropriate: clinical examination, post-mortem examination, bacteriology with culture and sensitivity, and other laboratory tests to arrive at the most definitive diagnosis possible before initiating a specific course of treatment with an antimicrobial agent. Evaluation of environmental factors and husbandry at the production site (e.g. water quality) should be considered as potential primary factors leading to infection and should be addressed prior to prescribing a course of antimicrobial agent treatment.
If therapy with an antimicrobial agent is deemed necessary it should be initiated as soon as possible. The selection of the agent should be based on the knowledge and experience of the veterinarian or other aquatic animal health professional authorised to prescribe veterinary medicines.
As soon as possible, susceptibility testing of the target microorganism should be used to confirm the choice of treatment. Results of all susceptibility tests should be retained and should be available to the Competent Authority.
The veterinarian or other aquatic animal health professional authorised to prescribe veterinary medicines should indicate precisely to the aquatic animal producer the treatment regime, including the dose, the treatment intervals, the duration of the treatment, the withdrawal period and the amount of antimicrobial agents to be delivered, depending on the dosage and the number of aquatic animals to be treated.
The use of antimicrobial agents extra-label/off-label may be permitted in appropriate circumstances in conformity with the relevant legislation.
Records on the use of antimicrobial agents should be kept in conformity with the relevant legislation. Veterinarians or aquatic animal health professionals should also periodically review farm records on the use of the antimicrobial agents to ensure compliance with their directions and use these records to evaluate the efficacy of treatment regimens. Suspected adverse reactions, including a lack of efficacy, should be reported to the Competent Authority. Associated susceptibility data should accompany the report of lack of efficacy.
Responsibilities of aquatic animal producers
Aquatic animal producers should implement health programmes on their farms in order to promote aquatic animal health and food safety. This can be done through adequate planning of culture strategies to maintain aquatic animal health through biosecurity programmes, husbandry, nutrition, vaccination, maintenance of good water quality, etc.
Aquatic animal producers should use antimicrobial agents only on the prescription of a veterinarian or other aquatic animal health professional authorised to prescribe veterinary medicines, and follow directions on the dosage, method of application, and withdrawal period.
Aquatic animal producers should keep adequate records of antimicrobial agents used, bacteriological and susceptibility tests, and make such records available to the veterinarian or other aquatic animal health professional.
Training of users of antimicrobial agents
The training of users of antimicrobial agents should involve all the relevant organisations, such as relevant regulatory authorities, pharmaceutical industry, veterinary schools, research institutes, and veterinary professional organisations and other approved users such as aquatic animal owners.
To address the significant lack of information for numerous species of aquatic animals, the relevant regulatory authorities and other stakeholders should encourage public-funded and industry-funded research.
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