A decision on whether to reschedule a pain relief drug used in tail docking and castration device Numnuts is expected to be made next month.
In 2021 Numnuts founder Robin Smith won approval from the Therapeutic Goods Association to reclassify its lidocaine-based drug NumOcaine as an S5 drug, meaning the local anaesthetic would be available over the counter through rural retailers and online as opposed to solely through veterinarians.
But a proposed amendment to the current Poisons Standard seeks to reverse that decision.
The reversal application raised concerns raised that the tamper-resistant condition packaging could be circumvented by dispensing the solution into a different vessel and that the drug could be used as a masking agent in performance animals "or to perform painful acts of veterinary science, with poor animal welfare outcomes".
The applicant argued that access to the 2 per cent lidocaine for use on livestock "is not impeded by the involvement of veterinarians, and veterinary oversight of the quantities and use of the substance is important to mitigate the risks of misuse or diversion".
The reversal application has effectively thrown last year's interim decision into limbo but if dismissed by the TGA, the process will then move to the next stage where the Australian Pesticides and Veterinary Medicines Authority will decide if it approves the new label claim.
During the initial TGA consultation period the Australian Veterinary Association made a submission against the rescheduling of the drug, stating that inappropriate administration of the product could cause severe side effects and that veterinarian involvement would help to control distribution.
Mr Smith said it was up to the TGA to weigh up "what we believe is a small chance for misuse or abuse versus the improvement in lamb welfare we think it will bring by making it more widely available".
WoolProducers Australia, SheepProducers Australia, Australian Wool Innovation and RSPCA Australia were among the entities supporting the rescheduling.
Mr Smith said they were now two years into the rescheduling process and it had been very complicated.
"It has been incredibly hard to meet the expectations of every party involved in the supply chain," he said.
"Farmers are used to being able to go to their rural stores to pick up everything they need at lamb marking time.
"The challenge we have in building adoption for our product is that unfortunately many sheep producers we come across don't have a relationship with a vet... unfortunately making a separate trip or call to the vet means it goes into the too-hard basket.""
Mr Smith said sheep veterinarians would still play a significant role in the distribution of the drug but he believed that rescheduling would help make the product more mainstream.
"There are about 10 or so sheep veterinarians who have really gotten behind the product and been wonderful... but to really drive the product out there, the numbers don't stack up," he said.
"We're at saturation point with veterinarians but we're still only reaching two to three per cent of the Australian flock.
"There's generally been a handful of vet practices that hold stock of NumOcaine.
"Most veterinary practices the rest wait until they get a confirmed order from a client and then place an order on us. We then process and ship as fast as we can, which has placed a huge amount of pressure on logistics, particularly during COVID-19.
"As an S5, after online checks at point of order (to ensure we are sending to a bonified famer), it would be possible to send traced NumOcaine direct from our warehouse direct to the farm gate
"Graziers should plan lamb marking supplies weeks or months ahead yet we've discovered sheep producers don't really like to order until the last minute when they know how many sheep and lambs they've got on the ground... the ag stores are accustomed to holding stock close to their clients for when they need it."
Although the interim decision on the reversal decision will be made in mid-March, the outcome will not be published into early June, with a final decision due in October.
During the 2022 lamb marking season, NumOcaine will continue to be available through veterinarians.
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