Good antibiotic practices for practitioners in the French OJ
The Order establishing good antibiotic practices was published in the French Official
Journal of 10 September. It contains “urgent recommendations” in particular for
veterinarians, but few new obligations. However, respect for some of these obligations
will not be easy, like the one on antibiotic combinations, which “should be avoided
unless absolutely necessary”.
The Law on the Future of Agriculture was to be published before June 30. The order,
proposed on 26 June by the French health safety agency (ANSES), was signed on 22 July.
The good antibiotic practices were finally published on 10 September, and became
enforceable the very next day.
No criminal penalty, but disciplinary consequences
The Law on the Future of Agriculture did not provide for criminal sanctions if the rules of the
Order are breached. However, for veterinarians, non-compliance can still lead to disciplinary
actions. Indeed, article R. 242-33 of the French Code of Professional Conduct stipulates:
 In paragraph III, that “veterinarians are required to fulfil all duties imposed on them
by laws and regulations. They should perform the acts related to their profession
following the rules of good veterinary practice”;
 And, in paragraph VII, that “veterinarians should take into account the impact of their
professional activities on public health, in particular in relation to antibiotic
resistance”.
Curative: yes, metaphylaxis: yes if..., prophylaxis: no unless...
For antibiotics, curative use is the rule, according to the Order. “Antibiotics are mainly
targeted at curative use”, for individually or group-housed animals.
Metaphylaxis (treatment of healthy animals in contact with diseases animals) requires the vet
to examine the diseases animals, to perform a benefit-risk analysis and to take into account
the health history of the farm.
Preventive use of antibiotics, however, is clearly “to be avoided”. It is “restricted (only) to
situations in which there is no other way to control disease. In no case should it be a
substitute for good biosecurity.”
For immediate use – so no on-farm stock
Antibiotics are not prescribed in advance. This means there is no reason that livestock farmers
should have them in stock in their medicines cupboard. Since “the validity of an antibiotic
prescription is intended for immediate use”.
Renewal prohibited or “to be avoided”
For this reason, “the renewal of an antibiotic prescription is a practice to be avoided”, even if
it is not formally prohibited by the text.
However, most antibiotics are already recorded in List I of poisonous substances. Renewal of
such a prescription is therefore already prohibited by law, except when bearing an explicit
mention by the prescribing veterinarian to the contrary, e.g. “to be renewed x times”, and
within the legal prescription validity period of one year.
For over-the-counter sales, one vet only…
In food-producing animals, the text does not prohibit over-the-counter antibiotic prescription
(without clinical examination). This remains a fairly common practice for the sales of some
classes of antibiotics such as intramammary tubes.
In these cases, the Order recommends that farmers use one and the same veterinarian (so a
single practice) for the herd health scheme and the protocol of care, allowing the veterinarian
to prescribe and dispense without clinical examination. Alternatively, if several vets carry out
herd health schemes and draw up protocols of care, all the different documents should be
“brought to the attention of the different veterinary practitioners”. The aim is to avoid “a
proliferation of antibiotic prescriptions by different vets” in case the farmer goes around
visiting all competing practices in order to obtain the antibiotics he wants.
Leftovers: “prescription-only” or even “prohibited”
To avoid self-medication, the use of leftover (unexpired) antibiotics requires a new
prescription, the Order warns farmers.
However, for companion animals, the text is stricter. The re-use of leftover antibiotics is
“strictly forbidden”, as is self-medication with human antibiotics. The owner “should ensure
that no leftover antibiotics remain in stock at his home, in order to avoid future use”.
Bacteriology: “as often and as early as possible”
Bacterial culture and sensitivity testing will not become compulsory. However, the tests are
strongly recommended for any antibiotic treatment, not just for critical antibiotics.
“Bacterial culture and sensitivity testing should be performed as often as possible and as
early as possible, in untreated animals”.
“Analyses should be performed in veterinary diagnostic laboratories” (not in human ones).
Their results should take into consideration interpretation criteria that have been validated for
veterinary medicine for the classification of R (resistant), I (intermediate) and S (susceptible).
They only mention substances that are authorised for veterinary use (excluding antibiotics
restricted to human medicine). Sensitivity testing is only one of ten selection criteria for an
antibiotic, for which the number one criterion is “the experience and the knowledge of the
veterinarian”.
However, in case of treatment failure or relapse, microbiological tests are almost mandatory
prior to the prescription of a second-line treatment.
De-escalation after the emergency
“In emergency situations or if sampling is not feasible, antibiotic treatment can be prescribed,
possibly pending results”. Once these are obtained, antibiotic treatment is then adjusted for
‘de-escalation’ purposes if possible.
As soon as the microbiological results are known, de-escalation consists of returning to
narrow-spectrum, first intention antibiotics, rather than continuing the use of large-spectrum
critical antibiotics prescribed in severe emergency cases. This is because the selection
pressure for resistance is correlated to the duration of treatment.
Antibiotic combinations: avoid “unless absolutely necessary”
“The use of antibiotic combinations is not recommended. In case of absolute necessity, it may
be considered and justified.” The Order does not specify if the “non recommended”
combinations are targeted at all combinations, including common old antibiotic combinations,
whether injectable (e.g. penicillin/streptomycin, ampicillin/colistin), topical or intramammary;
or only the combinations of several substances on the same prescription, like to association of
an injectable antibiotic with an intramammary one; or of a fluoroquinolone with a betalactam.
Common sense probably dictates that the synergetic combination trimethoprim-sulfa is not
targeted by this provision.
Furthermore, combinations aimed at broadening the spectrum are the main targets of the new
legislation. Since, although very often an additional antibiotic does not add anything in terms
of activity, it increases the selection pressure for resistance, or even multi-resistance.
Critical antibiotics: waiting for an Order
“The use of critical antibiotics should be in compliance with the legislation in force”, alluding
to a Decree which has still not been published. However, the proposals were widely circulated
and discussed late 2014. The clinical examination and antibiotic sensitivity testing – whenever
feasible – should become mandatory for at least fluoroquinolones and last generation
cephalosporins (3GC/4GC).
Off-label may be justified by… EBM
According to this Order, “ the veterinarian ensures that, besides his knowledge and
experience, his prescription is based on data obtained in agreement with evidence-based
medicine (EBM)”. No surprisingly, veterinarians prefer the marketing authorisations or rather
the SPC (summary of product characteristics) for the species, indications and dosage. If he
decides not to follow these, the decision should be justified.
SNGTV Factsheets
In case the dosage is modified, the Order recommends the prescriber to rely on fact sheet
recommendations per species and per disease issued by professional organisations, the
SNGTV (French farm animal veterinary society) for food-producing animals.
Refrigerated cabinets fitted with an alarm
Both veterinarians and pharmacists should be equipped for the storage of antibiotics with
“refrigerated cabinets fitted with a temperature monitoring system and an alarm”. Even
though the very large majority of antibiotics are not heat-sensitive (with some notable
exceptions such as injectable “pen-strep”).
Source:
Order of 22 July 2015 on the good practices of the use of medicines containing one or more
antibiotic substances, in veterinary medicine (OJ 10/9/15, in French).
http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000031142007&dateTexte
=&categorieLien=id