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MPI’s Agricultural Compounds and Veterinary Medicines team outlines the reasons and procedures for reporting medicine-related adverse events. NEARLY 1,700 VETERINARY medicines are registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997. Each has conditions that aim to manage the risks of its use to animal welfare, trade, agricultural security and public health. However, by the time they are launched even the most extensively studied veterinary medicines (products) will have been used in a relatively small number of animals in controlled environments. This means that their full efficacy, safety and residue profiles, and the suitability of their registration conditions, may not be fully established until after they have been used on a large number of animals under realworld conditions. If problems arise, the veterinarians and owners using the products have a responsibility to act – and the most important tool for doing this is ‘adverse event reporting’. Through adverse event reporting, a product’s risk profile can be verified and its risk management controls confirmed as adequate. It is the superpower for end users of veterinary products, because as a feedback tool it gives veterinarians, owners and animals a voice. The system works best when all adverse events, whether they are identified on labels or not, are notified when they occur. If there is any doubt about the potential involvement of a veterinary product, the event should be reported.
38 – VetScript August 2020
WHAT IS AN ADVERSE EVENT? In essence, an adverse event happens when something goes wrong when an animal is treated with a veterinary product. It includes a failure to achieve efficacy claims, illness, death and withholding-period issues. Events that should be considered adverse include: » injection and application site reactions » clinical abnormalities and deaths » a failure of a product to meet its label efficacy claims, including events that have non-product-related causes, such as anthelmintic or antibiotic resistance » a failure of a product to perform as expected, even if inefficacy does not result (eg, premature regurgitations of capsules, problems using a product due to a characteristic of the product) » suspected product quality issues leading to toxicity » unacceptable residue levels in meat, milk or eggs » human reactions to products, particularly those not recognised on-label. Other adverse events that should be reported include: » those that occur in domestic and farmed animals as a result of exposure to vertebrate toxic agents (VTA) such as rat poison, and chemicals used on plants, including fodder crops (these products are managed for these animals under the ACVM Act)
» VTA residues occurring in the edible tissues of wild animals caught for human consumption » all cases of environmental or other non-target-species exposures to VTAs (these should be reported to the Environmental Protection Authority). Animal feeds and supplements are also regulated by the ACVM Act but they (along with many other products such as shampoos used to treat animals) do not have to be registered before they can be sold. The producers are still required by law to produce products that are fit for purpose, but how they do this are not assessed by the Ministry for Primary Industries (MPI) before they go to market. For this reason any adverse events related to these products should be reported. WHY SHOULD ADVERSE EVENTS BE REPORTED? There are seven good reasons for veterinarians to report all adverse events they encounter.
1.
Reports of adverse events are the only real-time, New Zealandspecific mechanisms for confirming that the conditions applied to product registrations can manage the product risks effectively.
2.
Adverse event reporting may be the only way to discover product
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