This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/240
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Scope of the program
The APVMA defines an adverse experience as an unintended or unexpected effect on animals, human beings or the environment, or a lack of efficacy associated with the use of a registered agricultural or veterinary chemical product when used according to the approved label instructions.
The scope of the AERP is broad. It allows us to receive adverse experience reports involving registered veterinary medicines and agricultural chemical products as defined in the Agvet Code when used according to label instructions. The AERP may decide not to consider a report because it falls outside the scope of the program.
Table 1 shows whether specific adverse experience reports (AERs) are in or out of the scope of the AERP.
|Adverse experience report type||In scope or out-of-scope|
|Related to human health issues, where people are exposed to these products either by using them, coming in contact, consuming treated produce, or being exposed as bystanders||Yes|
|Related to animal health issues, including both domestic and native birds and animals||Yes|
|Related to crop and plant damage||Yes|
|Related to lack of efficacy||Yes|
|Related to environmental damage||Yes|
|Related to residue issues||Yes|
|Related to known side effects of veterinary medicines already identified on product labels||Yes|
|Related to trade issues (as these do not fall within the definition of an ‘adverse experience')||No|
|Related to packaging design faults (as these do not fall within the definition of an ‘adverse experience’)||No|
|Related to products not registered by the APVMA||No|
Reporting off-label adverse experiences
The scope of the AERP does not cover reports involving the off-label use of registered products. However, the 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.