Rescheduling of drugs of importance to the veterinary profession – have your say

The TGA is seeking public consultation on a range of drugs to discuss at an upcoming meeting. Drugs of relevance to the veterinary profession are: 

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

Public consultation is currently being sought on the proposed amendment, and the AVA is considering putting in a brief submission on: 

• Meloxicam – the AVA does not oppose this amendment with a caveat that veterinarians must be involved in the decision making around the use of analgesics in animals. 
• Animal blood products – the AVA supports this amendment. 

If you would like to put in individual feedback please do so by the 29th of September through the TGA website. 

Meloxicam rescheduling 

The TGA has received a request to amend the Schedule 6 entry for Meloxicam. The company that has applied for this rescheduling recently provided a brief to the executive of the SCGV to discuss any concerns sheep veterinarians may have about this proposal. 

 Background 

Currently meloxicam is listed in Schedules 4 and 6 of the Poisons Standard.  

• Schedule 6: oral transmucosal preparations containing 1% or less meloxicam for pre-surgical treatment and pain management in livestock during routine husbandry procedures 
• Schedule 4: MELOXICAM except when included in Schedule 6. (i.e. injectable meloxicam)   

The company who has made the current rescheduling application is proposing an additional entry in Schedule 6 of the poisons standard, as follows: 

ADD: 

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

AVA’s previous work on meloxicam rescheduling 

In 2022 the AVA opposed the rescheduling of meloxicam in both oral and injectable forms for the following reasons: 

• Unrestricted access to oral or injectable meloxicam provides opportunities for uncontrolled use of a potentially dangerous drug in a broad number of animal species, which may lead to significant harm. 
• This product has the potential to be abused by humans, and thus poses a public health threat if available in an unrestricted manner.  
• Inappropriate use without veterinary advice in target and non-target species poses risks not only to animal health and welfare, but also to human food safety, biosecurity, and public health. 
• Incorrect administration without veterinary advice may negate the analgesic effects of the medicine, leading to poor animal welfare outcomes.  
• Veterinary knowledge is important to meet label requirements to identify the presence of medical contraindications to use of the product, or any potential drug interactions, and to respond to adverse events including overdosage.  
• Meloxicam is currently regulated as a prescription-only medication in Australia, the USA, Canada, New Zealand, UK, Ireland, and Europe due to safety considerations. 
• It is noted that in 2005, the TGA introduced stricter measures around the prescribing of Cox-2 Inhibitors including meloxicam following the findings of a review into the safety of this family of medicines. 
• In both cases we did not believe that the applicant demonstrated a persuasive need to reschedule meloxicam to make the drug more accessible, as there was no impediment to supply through veterinarians. 

The AVA was ultimately successful in lobbying to keep injectable meloxicam as S4, due to the recognized higher risk of misuse and diversion to other species.  We were not successful in preventing the rescheduling of oral transmucosal meloxicam, and that is now S6.   

Current application:  injectable vaccines containing meloxicam for use in lambs at marking. 

This new application does relate to injectable meloxicam, but only when it is combined with vaccines for sheep.  The AVA believes this does not pose the same level of risk as stand-alone injectable meloxicam, as the dose is standardized in this case, and unlikely to be used in any other way than for which it is intended. 

Veterinarians fully support and encourage increased use of meloxicam to reduce pain during husbandry procedures in animals and to manage inflammation and pain, particularly when used as part of a multimodal analgesic plan for very painful procedures such as castration and dehorning.   

The AVA is 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 this reason we are not opposing this current rescheduling application.  

The one caveat under which AVA does not oppose the amendment is 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.  

 

Animal blood products 

An applicant has proposed to create a new Schedule 4 entry for animal blood products for veterinary use. Animal blood products are currently unscheduled and have not previously been considered for scheduling. Human blood products are currently captured in Appendix A which provides a general exemption from the controls set out in the Poisons Standard. 

The applicant’s proposed amendments to the Poisons Standard are:  

Schedule 4 – New entry  

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 INDEX  

 

• Animal blood products are currently extracted in private veterinary practices and used in-house for other animals. Additionally, there are some commercial suppliers who supply through wholesalers direct to veterinary practices. 
• There are currently several registered animal blood products with the APVMA for various animals including companion animals and production animals. While human blood products are regulated by the Therapeutic Goods Administration (TGA) and the National Blood Authority (NBA), there is no equivalent authority for the regulation of animal blood products. 
• Schedule 4 would be the most appropriate schedule to regulate access and supply as animal blood products must be administered by a veterinarian.  
• The human health risks associated with collection, handling and administration are low due to the products being handled only by appropriately trained staff. 

The AVA supports this application and believes 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.