AUSTRALIA’S Therapeutic Goods Administration has supported broadening access to the lamb and calf pain relief products lidocaine and oral transmucosal meloxicam by rejecting the appeal arguments of the Australian Veterinary Association.

However, the AVA intends to continue its fight to return the formulations – marketed respectively as NumOcaine and Ilium Buccalgesic OTM by Troy Laboratories — for use only under veterinary prescription.

NumOcaine is administered from a tamper-resistant bottle as injectable lidocaine as part of the Numnuts system for pain relief when marking lambs and calves. Buccalgesic is a meloxicam gel that is administered by oral application in the buccal (cheek) pouch in lambs.

In September last year, the Therapeutic Goods Administration rescheduled Lidocaine (NumOcaine) from an S4 veterinary prescription-only drug to S5 on the Poisons Standard, allowing it to be sold through rural resellers. Buccalgeisc was also rescheduled.

The AVA then appealed the TGA’s rescheduling, citing concerns of potential misuse, toxicity and the degree of tamper resistance offered by the NumOcaine cartridge.

However, last Friday the TGA published the decision of its delegate, who found that the benefits of greater access to an injectable lidocaine preparation outweigh the potential risks.

“Therefore, I have decided to not amend the Poisons Standard in relation to lidocaine.”

TGA decision ‘a shot of utter relief’

Numnuts founder Robin Smith said in the three years that Numnuts has been on the market, the company had received numerous appeals from farmers and peak councils to streamline the availability and access of our pain relief product.

“The rescheduling process began over two years ago, and with the support of hundreds of farmers, the RSPCA, WoolProducers, Sheep Producers of Australia and Australian Wool Innovation and veterinarians representing the industry, NumOcaine was successfully rescheduled to S5 status in July 2022, thus pathing the way for improved access.

“The attempt to reverse this decision by the policymakers at the AVA has sat like a rubber ring on an essential part of our enterprises’ anatomy for over nine months now.

“The decision by the TGA today feels like a shot of utter relief,” he said.

“This, the third green light from TGA allows us to plan for the future.

“We remain committed to working with vets to increase the uptake and ensure the best animal welfare outcomes,” Mr Smith said.

“Working with everyone in the farm supply chain, we hope to see an increase in the use of Numnuts/NumOcaine.

“Achieving that goal will enable us to fund further R&D on improved formulations and, hopefully, a pain relief solution for young calf ring castration,” Mr Smith said.

“Moving forward, we hope we can find a way for all involved in animal welfare; farmers, vets, scientists, rural merchandisers and innovators, to achieve a sustainable business model that works for all.”

Although NumOcaine in June this year was approved by the Australian Pesticides and Veterinary Medicines Authority for over the counter sales, it is only be available through veterinarians this year due to current labelling laws. Mr Smith said NumOcaine labelled for over-the-counter sale will not be available until 2023.

The sheep vets will appeal the TGA’s interim decisions

President of the Sheep, Camelid and Goat Veterinarians (an AVA special interest group), Dr Susan Swaney, said the SCGV is extremely disappointed in the interim decision by the TGA to allow lidocaine (NumOcaine) to remain an S6 and for the rescheduling of Meloxicam 1 percent to S6.

“A decision to make these products available to sheep producers on the open market will limit the opportunity for veterinarians to support producers making the best choices of drugs available for reduction of pain during routine husbandry procedures on sheep,” she said.

Dr Swaney said the SCGV’s concerns included the potential for Lidocaine (NumOcaine) toxicity especially when used alongside Trisolfen at mulesing, the limited timeframe of NumOcaine’s activity and the development of posterior paresis in lambs where the needle is inserted incorrectly.

“Despite the fact that most farmers wish to do the right thing by their livestock, there is still a portion of farmers and also other members of the public who will now have access to unlimited volumes of these products, that may choose to use them in the wrong way.

“Sadly, as a veterinarian I have seen many occasions where animals have been severely mistreated as the result of people believing that they can carry out procedures without the required training,” she said.

“I believe a totally unrestricted access to these drugs will dramatically increase the opportunity for this type of misuse with dire outcomes not just for sheep but for multiple animal species and potentially for humans.”

Dr Swaney said the welfare of all animals is a major concern of veterinarians.

“As such, it is our obligation to continue to appeal this interim decision in the hope that the best outcome can be found for sheep and goat producers and their flocks as well as all other animals or humans that may be affected by this decision.”

Dr Swaney said she hoped that the sheep farmers who have thought about this carefully would realise that a decision to change the access to these products could result in increased potential for their misuse, particularly where anyone could potentially buy as much as they wanted online.

“Advice from veterinarians including how to use them, alone or in combination, for immediate and long-term pain relief, and for avoiding potential side effects or toxicity, will support producers making the most effective, practical and cost effective choices for their livestock.

“Consumers are growing increasingly aware of how their food is produced and I believe their expectation is that there would be some veterinary oversight of animal welfare on farms,” she said.

“The SCG veterinarians work hard to connect with their clients and this relationship is crucial for the industry to be well protected and well-resourced into the future.”

Potential for lidocaine misuse is minimal – TGA

The TGA’s delegate said injectable preparations of lidocaine for animal use have a favourable safety profile with a low potential for causing harm to humans and a product that is deemed to have tamper resistant packaging by the regulator also presents a reduced risk of diversion and misuse. The use of the applicator also reduces the likelihood of accidental self-injection during administration of lidocaine to the animal, the delegate said.

The delegate also said the potential for abuse of lidocaine is minimal or non-existent, as the substance does not develop dependency and is not regarded as a drug of abuse. The isolated reports provided in the appeal application are insufficient to demonstrate that misuse of an injectable lidocaine preparation designated for veterinary use is likely. As lidocaine is currently readily available at relatively low cost in a multitude of different preparations for human use, the delegate found that it is unlikely that veterinary preparations of this kind would be diverted in this way. I also consider it unlikely that these preparations of lidocaine would be used in the dilution or “cutting” of illicit drugs, the delegate said.

“Based on the number of public submissions stating the difficulties in accessing lidocaine for veterinary procedures, I disagree with the applicant’s statement that there are no significant barriers to access.

“Enabling greater access to lidocaine with the appropriate safeguards in place as provided by the specialised packaging (applicator) should contribute to greater uptake of pain relief medication by the farming community for these veterinary procedures, particularly in remote areas where veterinary oversight may not be readily available.

“In making my decision, I agree with the committee (TGA’s Advisory Committee on Medicines and Chemicals Scheduling) that there is insufficient evidence of actual or potential detrimental effects associated with lidocaine preparations that would be captured by the existing Schedule 5 entry, to justify overturning the original decision related to the introduction of a specific entry for the specified indications and applicator.”

Click here to read the full TGA decisions.