Your role when medicines go wrong

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.

MPI’s Agricultural Compounds and Veterinary Medicines team outlines the reasons and procedures for reporting medicine-related adverse events.

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

quality issues that could have serious and widespread consequences unless action is taken urgently. 3. Warnings of product issues can be communicated quickly and widely if all instances are reported. 4. MPI can only impose label warning statements of potential adverse effects if there is enough data supporting a true product-event relationship. 5. The extent and impacts of product characteristics that develop unexpectedly in the field (eg, sludge forming at the bottom of a product, unable to fully re-suspend) may only be identified and rectified if all instances encountered are reported. 6. The use patterns and risk profiles of established products can change over time, and this may necessitate changes in conditions. 7. It may not be apparent that an event is an isolated incident or representative of a product-wide problem until it is considered alongside other event reports from users of the same or similar products. MPI is the only agency that can evaluate adverse event information for similar products sold by different companies.

HOW CAN I LODGE AN ADVERSE EVENT REPORT?

Veterinarians and animal owners can send adverse event reports to MPI, the product registrants or the parties responsible for the products.

To report an event to MPI, complete and send the MPI adverse events report form (which includes guidance) at www.

mpi.govt.nz/processing/agriculturalcompounds-and-vet-medicines/ adverse-events-with-acvms.

Given that the reason(s) for an adverse event is not always clear, MPI needs as much detail as possible to establish and assess causality. We recommend that veterinarians include clinical records with adverse event reports.

Each report provided to MPI is sent to the responsible party for investigation, and a closure email is sent to the veterinarian or owner summarising MPI’s decision on the products’ involvement.

Product registrants must by law report all adverse events they receive to MPI, so if a report is sent only to the registrants, MPI will be notified.

2020 WVAC Virtual Congress Proceedings

Proceedings of the 36th World Veterinary Association Congress: Volume 1 of 3 Animal Welfare • Equine • Dairy Cattle Sheep, Beef Cattle & Deer • Aquaculture 26 April – 16 May 2020, Virtual Congress

Proceedings of the 36th World Veterinary Association Congress: Volume 2 of 3

Companion Animal 26 April – 16 May 2020, Virtual Congress

Proceedings of the 36th World Veterinary Association Congress: Volume 3 of 3 Veterinary Public Health • Veterinary Nursing (Companion Animal & Equine) • Large Animal Veterinary Technicians • Academic & Education • Veterinary Business 26 April – 16 May 2020, Virtual Congress

For a complete archive of all proceedings visit www.sciquest.org.nz

For a complete archive of all proceedings visit www.sciquest.org.nz For a complete archive of all proceedings visit www.sciquest.org.nz