Download Metaphylaxis of healthy in contact animals to replace

“Metaphylaxis” of healthy ‘in contact’ animals to replace
“prevention” in an infected environment
From now on, “metaphylaxis” is a term recognised by the European Medicines
Agency (EMA). It refers to the treatment of clinically healthy (but presumably
infected) in-contact animals. However, it does not include the treatment of animals on
premises that are presumably infected due to the former (not contemporary) presence
of sick animals.
From now on, the European Medicines Agency for human and veterinary health recognises
two possible uses for veterinary antibiotics: “treatment” and “metaphylaxis”. The word
“prevention” in combination with “treatment” is to be replaced by the word “metaphylaxis” in
the SPCs (summary of product characteristics) of the approved antibiotics.
Definitions for 2015
The European definitions for 2015 are as follows.
1. The term “treatment” refers to the treatment of an individual animal, or a group of animals
showing clinical signs of an infectious disease. This implies curative treatment only.
2. The term “metaphylaxis” refers to the administration of the product at the same time to a
group of clinically healthy (but presumably infected) in-contact animals, to prevent them
from developing clinical signs, and to prevent further spread of the disease. The presence
of the disease in the group/flock must be established before the product is used.
A number of antibiotics have indications containing the expression “for treatment and
prevention”. In the mid- to long-term, this expression is to be replaced by “treatment and
metaphylaxis”. The EMA recalls that a metaphylaxis claim will always have to be combined
with a treatment claim.
The word “prevention” open to interpretation
In 2011, the EMA underlined that the term “prevention” when used for an antimicrobial
product should not be understood as “routine preventive use on healthy animals”. However, a
number of antimicrobial products for food-producing species have indications containing the
expression “prevention” or “preventive treatment” against infections.
It is clear that the word “prevention” is open to a wide range of interpretations and
translations, leading to differences in the indications for use in the SPCs for the same product
in different countries/languages. The EMA is concerned that no difference is made between
vaccines and antibiotics regarding the “prevention” of disease in healthy animals.
In France: “prevention in an infected environment”
French authorities have accepted the term “prevention in an infected environment” in the data
sheets. This includes the “prevention” of disease in healthy in-contact animals, or
“metaphylaxis” in English.
However, “prevention in an infected environment” also includes the protection of healthy
animals against clinical disease on presumably infected premises, where a pathogen was
detected in an earlier batch of animals.
Metaphylaxis of in-contact animals
However, metaphylaxis does not include the prevention of disease in healthy animals on
presumably infected premises since the sick animals were in a previous batch. It only refers to
the treatment of healthy but presumably infected in-contact animals – and not to those that
were presumably infected because they were housed in barns in which sick animals had been
housed in earlier batches.
The benefit of metaphylaxis to be proven
Regarding clinical trials of new antibiotics, the EMA should be quite strict when accepting
the claim of metaphylaxis. Such trials should prove that metaphylaxis presents a clear benefit
over the treatment of individual animals or a group of animals showing clinical signs of
disease. Quite a challenge.
Source:
European Medicines Agency (EMA). Question and answer on the CVMP guideline on the
SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005).
EMA/CVMP/414812/2011-Rev.1
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500109155.pdf