AERP VET GLOSSARY (KP81P3)

Adverse experience

An adverse experience is an unintended or unexpected effect on animals, human beings or the environment, including injury, sensitivity reactions or lack of efficacy associated with the clinical use of a veterinary chemical product.

Causality assessment

The relationship between the use of the veterinary chemical product and the reported clinical signs, assessed after investigation of the incident has been carried out. The relationship is expressed in terms of:

Probable (algorithm score 3 to 7)

For inclusion in the category 'probable' all of the following minimum criteria should be met:

• there should be a reasonable association between the administration of the product and onset and duration of the reported adverse experience,
• the description of the clinical signs should be consistent with or at least plausible given the known pharmacology and toxicology of the product, and
• there should be no other equally plausible explanation (or contributing factors) for the clinical signs.

When any of the above criteria cannot be satisfied (due to lack of sufficient information or conflicting data) then the association cannot be assessed as 'probable'.

Probable/Off-label (algorithm score 3 to 7)

As per the classification of 'probable' and where there is obvious evidence of off-label use (including use in species not listed on the product label, over-dosing or under-dosing).

Possible (algorithm score 0 to 2)

For inclusion in the category 'possible' association of the adverse experience with administration of the primary suspect product is one of other possible and equally plausible explanations (or contributing factors) for the described adverse experience.

Possible/Off-label (algorithm score 0 to 2)

As per the classification 'possible' and where there is obvious evidence of off-label use (including use in species not listed on the product label, over-dosing or under-dosing).

Unlikely (algorithm score -1 to -6)

Where sufficient information exists to establish that the described adverse experience was not likely to have been associated with administration of the product(s), or other more plausible explanations exist, the assessment should be categorised as 'unlikely'.

Unknown

All adverse experiences where reliable data is either unavailable or is insufficient to make an assessment should be categorised as 'unknown'.

Mandatory adverse experience report

Registrants of veterinary chemical products have a mandatory obligation under the legislation to maintain a record of all adverse experiences reported to them and to make this record available to the APVMA according to the AERP Vet guidelines.

Serious adverse experience

A serious adverse experience is any adverse experience that results in death, is life-threatening, results in persistent or significant disability/incapacity, prolonged duration of serious signs or is a congenital abnormality or birth defect. A serious adverse experience in humans is one that requires medical treatment or involves death.

Within animals managed and treated as a group only an increased mortality or increased occurrence of serious signs, exceeding the rates normally to be expected in that particular case, are to be considered as a serious adverse experience.

The following table is offered as a guide only in determining if an adverse experience is to be regarded as serious.

Small animals Death Hospitalisation Welfare implications	Horses death Hospitalisation or more than one veterinary visit Welfare implications
Cattle, sheep and pigs Deaths More than one veterinary visit >10% morbidity Welfareimplications	Poultry >5% increase in base mortality >10% morbidity Welfare implications
Humans Death Medical treatment required

Where there is any doubt about the seriousness of a suspected adverse experience or where the complainant or the reporting person disagrees with the Registrant's assessment of seriousness, the incident must be reported by the Registrant to the NRA within seven (7) working days.

Voluntary adverse experience report

Adverse experience reports that are submitted to the APVMA voluntarily by veterinarians, farmers, animal owners and other users of veterinary chemical products.