Quote from VigiServe Admin on November 26, 2020, 10:36 AM

How do you undertake reporting?

https://portal.apvma.gov.au/aerp

What should be reported?

All Domestic Serious Reports

The following provides a quick guide to determine if an adverse experience is to be regarded as serious.

Humans

• death

• medical treatment required.

Cattle, sheep and pigs

• death

• more than one veterinary visit

• more than 10 per cent morbidity

• welfare implications.

Horses

• death

• hospitalisation or more than one veterinary visit

• welfare implications.

Poultry

• more than five per cent increase in base mortality

• more than 10 per cent morbidity

• welfare implications.

Small animals

• death

• hospitalisation

• welfare implications.

 

APVMA does encourage the reporting of off-label adverse experiences as these have occasionally highlighted potentially significant issues with registered products. Some examples of this are:

• treatment protocols involving the administration of products meant for production animals to companion animals have resulted in illness or death of the treated animal

• the use of dog products on cats can cause serious adverse effects. This action is clearly off-label and the public should be aware that certain constituents (such as high concentration permethrin) are toxic to cats

• spray drift from chemical application contrary to label instructions can result in environmental damage or human exposure to harmful chemicals

• accidental human exposure to veterinary medicines, particularly injectable products (such as vaccines) can cause unpleasant and potentially harmful adverse experiences.