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Reporting Adverse Events

The ACVM Group is revising the procedures for assessment and reporting of adverse events arising from the administration of veterinary medicines.

Under section 23 of the ACVM Act the Director-General may register a product subject to conditions specifying the quality, purity and potency of the product and the requirements for information and records to be kept and reported. Under section 29 of the Act the Director-General may, after consultation with the registrant, decide to reassess a product if significant new information concerning the use of a product becomes available.

Adverse reactions relate directly to animal welfare concerns that are identified as one of the risk areas addressed under the Act. Therefore, the requirement for the notification of adverse reactions will continue under the new legislation and may become a condition of registration for some veterinary medicines.

A new report form, the Adverse Event Report (AER), is being introduced. The change from the previous adverse reaction report to the new Adverse Event Report signifies that we expect not only reactions to the active component of the remedy to be reported but also any physiological reactions arising from any administration device that might have been used.

The definition of an adverse event will include:

• any situation when an active ingredient or final formulation exhibits unintended reactivity;
• any situation when a negative outcome is considered to be more likely due to causes other than being directly attributable to an active ingredient or formulation, for example the shape or structure of a product or applicator;
• any case where a product appears not to be efficacious;
• any instance when residues in excess of the defined level are notified.

The new Adverse Event Report forms will be made available to veterinarians and licensees of veterinary medicines.

Under the proposed new process, all AERs received by the ACVM Conformance Team will be registered in the existing data base, and arrangements for assessment and follow up will be made with either internal or consultant assessors as appropriate.

The trends will be reviewed regularly within the ACVM Group for any potential problems that might be developing with a product type so that actions might be agreed early to resolve or contain negative impacts.

It is proposed to develop a quarterly summary of adverse event trends for notification in AgVetLink.