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Changes in the prescription of antimicrobials in the EU: questions and answers (I)

Must a veterinarian treat sick animals, whatever the circumstances or conditions that have favoured the emergence of the disease? Prophylaxis or metaphylaxis?

Bacterial resistance to antimicrobials is a public health problem already accepted at a global level.

The European Union (EU) has implemented different initiatives aimed at the reduction in the use of antibiotics. These actions have aroused doubts and worries regarding the next steps that the authorities plan to take.

Next we will try to answer some questions.

European Regulation 2019/6 on veterinary medicinal products, to be implemented in the future, says: “Antimicrobial medicinal products shall not be applied routinely nor used to compensate for poor hygiene, inadequate animal husbandry or lack of care or to compensate for poor farm management.” Must a veterinarian treat sick animals whatever the circumstances or conditions that have favored the emergence of the disease?

The new EU Regulation on veterinary medicinal products shows a new way of using antibiotics. On many occasions, in order to treat a disease, the use of antibiotics is suggested as a preventive measure, instead of modifying the hygiene or biosecurity on the farm. The new legislation says that antibiotics will still be used, but only in those cases in which they are necessary, and therefore we must work more in terms of prevention, improving the biosecurity and hygiene on the farms, working on a good vaccination plan as well as on the training aimed at farmers, lorry drivers and the rest of the essential actors that are involved.

Although the action of prescribing is a veterinary action, the decision regarding the rearing conditions of the animals are in the hands of the farmers or business owners, and the administration of the antibiotics is carried out ultimately by the staff on the farms. What measures will the authorities take to expand the raising of awareness regarding that the administration of antibiotics to these groups of animals must be reduced?

Antibiotics are drugs that must be administered by a veterinarian or under their responsibility, and therefore it is them who must ensure that the farmer understands correctly how to administer them and make sure that the administration is carried out correctly too. Also, and as we have said before, we will work specially in the training of these groups of people to inform them of the importance of the problem and how relevant it is their participation in this project.

It is very important to achieve the awareness of all the parties implied by working directly with them in the implementation of specific measures, according to the production characteristics, therefore achieving an improvement in the implementation of the biosecurity and hygiene measures.

Exceptional prescription

The authorities have informed that the use of the veterinary medicinal product must be restricted to the cases included in its package leaflet, and that any use different from that included in the information leaflet, even if it has only to do with the dosage, the directions for use or the length of the treatment must be carried out as an exceptional prescription. Isn’t it so?

Yes. Any off-label use of a drug must be prescribed exceptionally, except when used in the same species but in a different category (e,g. it is to be used in piglets but it is used in sows).

When a package leaflet specifies about the use of antimicrobials in pregnant or lactating sows “To be used only in accordance with the benefit/risk assessment carried out by the veterinarian in charge”, does its use imply an exceptional prescription?

No, but it implies that the responsibility of its use will fall on the veterinarian that makes the prescription bearing in mind the different elements that allow him/her to carry out the benefit/risk assessment.

How can treatments for the eradication of diseases that have more of a preventive than curative nature, and that in some cases entail lengthy treatments can be prescribed with the current criteria for the use of antimicrobials?

Antibiotics cannot be used as tools for the eradication of a disease. Only in the case of a specific plan and with a justification they could be included as a part of that plan.

Metaphylaxis vs prophylaxis

The European regulation clearly restricts the use of antimicrobials for prophylaxis and metaphylaxis. The regulation defines both practices as follows:

  • Metaphylaxis: means the administration of a medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk and which may already be subclinically infected
  • Prophylaxis: means the administration of a medicinal product to an animal or group of animals before clinical signs of a disease, in order to prevent the occurrence of disease or infection.

If a veterinarian prescribes antimicrobials to batch no. 5 before the emergence of the disease because batches no. 1, 2, 3 and 4 have shown a clinical picture of a certain disease, are they carrying out a prophylaxis or a metaphylaxis? Can this kind of treatment be carried out?

If the administration of the antibiotic is carried out before the clinical disease is present, it is a prophylaxis. The new European regulation specifies that the veterinarian shall justify the use of antibiotics whether used for prophylaxis or metaphylaxis. The systematic use of antibiotics for prophylaxis must be avoided and be used only in indispensable cases and individually. Regarding the use of antibiotics for metaphylaxis, it is essential that the disease has become established and that it is justified through an accurate diagnosis and a sensitivity profile that ensures that it is the only option we have.

In all cases, the veterinarians must always implement a good prevention plan, and in the event of a disease, have the data regarding the diagnosis and the sensitivity profile so, bearing them in mind, they can implement the most appropriate treatment strategy.

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