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Lack of efficacy - Veterinary

If the reported adverse event clearly relates solely to lack of expected efficacy, the term ‘lack of efficacy’ should be used in isolation without any of the observed signs indicative of the lack of efficacy.

For any reports resulting in fatalities, ‘death’ should also be coded. The term ‘uncoded sign’ should never be used to code for the disease being treated.
If the report describes clinical signs relating to both safety and lack of expected efficacy or if there is any doubt as to what type of case it is (e.g. if clinical signs appear to have worsened following treatment) it should be submitted as one combined report with all signs being coded including ‘Lack of efficacy’.
In order to provide further coding detail for multi-indication products e.g. combination antiparasitic products and multivalent vaccines, additional LLTs have been created, all situated within the PT ‘Lack of efficacy’.

Lack of efficacy LLTs are now grouped together using the following system to aid user coding: Lack of efficacy (bacteria), Lack of efficacy (ectoparasite), Lack of efficacy (endoparasite), Lack of efficacy (fungi), Lack of efficacy (mycoplasma), Lack of efficacy (protozoa), Lack of efficacy (virus) e.g. for Lack of efficacy (bacteria) the following LLTs exist:

Lack of efficacy (bacteria) - Borrelia
Lack of efficacy (bacteria) - Chlamydia
Lack of efficacy (bacteria) - E.coli
Lack of efficacy (bacteria) - Leptospira
Lack of efficacy (bacteria) - NOS
Lack of efficacy (bacteria) - Salmonella

Lack of expected efficacy following the use of euthanasia products should be coded using only the VeDDRA low level terms ‘lack of efficacy’ and ‘unrelated death’ (as the death was unrelated to the adverse event ‘lack of efficacy’). No other clinical signs observed should be coded using VeDDRA. In all cases, however, such reports are considered serious adverse events and should be reported accordingly.

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