Interim TGA decision supportive of AVA submissions – Animal blood products and Meloxicam in injectable vaccines

The TGA has handed down its interim decision regarding two veterinary medicines that the AVA made submissions on in 2023.

• Animal blood products
• Meloxicam - injectable vaccines containing bacterial antigens and 1% or less of meloxicam for single use in lambs undergoing husbandry procedures at marking. 

We are extremely pleased with the outcomes of our advocacy on both of these issues, this is a win for the profession and for animal welfare.

Animal blood products

The interim decision around animal blood products is they have been scheduled as

SCHEDULE 4 ANIMAL BLOOD PRODUCTS for veterinary use including:

a) whole blood;

b) blood components including red cells, white cells, platelets, and plasma (including cryoprecipitate); and

c) the following plasma-derived therapeutic proteins; and their equivalent recombinant alternatives:

(i) albumin;

(ii) anticoagulation complex;

(iii) C1 esterase inhibitors;

(iv) clotting factors;

(v) fibrinogen;

(vi) protein C;

(vii) prothrombin complex concentrate (PCC);

(viii) thrombin;

(ix) haemoglobin.

The AVA supported this application as the AVA is of the opinion that blood products should only be administered by veterinarians in the same way as other S4 medicines. This is owing to veterinarians’ knowledge of animal health and disease, the ability to identify the presence of medical contraindications to use of the products, or any potential drug interactions and to respond to adverse events. 

The Delegate said “I am of the opinion that the need for veterinary oversight to reduce risks to users and animal welfare, in particular the risks of product contamination and transmission of zoonotic diseases to humans, justifies implementing Schedule 4 access restrictions.”

“I would emphasise that the proposed scheduling change will not affect the ability of veterinarians to access and prepare their own animal whole blood and blood products for in-house emergency use. For these provisions, the Australian Veterinary Association (AVA) provides veterinarians guidance regarding in-house use of companion animal blood products.”

The implementation date for this scheduling change is 1 October 2024.

Meloxicam - injectable vaccines containing bacterial antigens and 1% or less of meloxicam for single use in lambs undergoing husbandry procedures at marking. 

The interim decision around Meloxicam is to amend the Schedule 6 entry to

SCHEDULE 6 - MELOXICAM in:

(a) oral transmucosal preparations containing 1% or less meloxicam for pre-surgical treatment and pain management in livestock during routine husbandry procedures; or

(b) injectable vaccines containing bacterial antigens and 1% or less of meloxicam for single use in lambs undergoing husbandry procedures at marking.

The AVA was of the opinion that the combination of meloxicam into vaccines for single use in lambs undergoing husbandry procedures at marking mitigates the risks we have previously raised, and at the same time will provide improved welfare for the animals. For that reason, the AVA did not oppose the rescheduling application. The AVA did state that the one caveat under which we did not oppose was that veterinarians must still be involved in the decision making around the use of analgesics in animals – given veterinary knowledge is important to meet label requirements and to identify the presence of medical contraindications to use of the product, or any potential drug interactions, and respond to adverse events including overdosage.  

The Delegate said “I recognise that some of the risks identified with potential misuse in discussions of previous scheduling applications for meloxicam are counteracted in this proposal by the co-formulation with a vaccine. I agree that the presence of the vaccine provides a sufficient deterrent to misuse, while the presence of meloxicam encourages the uptake of pain relief measures by farmers when performing husbandry procedures at marking. In addition, misuse of the product for pain relief in humans is unlikely due to the low concentration of meloxicam and potential adverse effects that may be experienced in reaction to the vaccine component.”

“Of particular interest was the submission from the Australian Veterinary Association, which did not oppose the proposed amendment, citing the reduced risk associated with the co-formulated product compared to a standalone preparation of injectable meloxicam. I acknowledge comments included in the submissions that veterinary professionals should ideally be involved in the administration of pain relief to animals as they are best placed to identify contraindications and respond to adverse events. However, I deem the risks associated with these factors to be sufficiently mitigated by the stipulations in this proposal.”

The implementation date for this scheduling change is 1 June 2024.