Stock Handling & Animal Welfare

MLA and AWI split on lamb pain relief drug scheduling

Terry Sim, January 31, 2022

MLA managing director Jason Strong: It is now apparent that the NumOcaine vials are not tamper proof.

MEAT & Livestock Australia has withdrawn its support for releasing the Numnuts lamb and calf pain relief product NumOcaine from veterinary-only prescription after providing more than $5.2 million in funding.

NumOcaine, with its active ingredient 2 percent Lidocaine, is a key element of the Numnuts system for which MLA and Australian Wool Innovation provided research and development funding.

However, the discovery that a NumOcaine bottle’s unique quick change cartridge top — initially described as ‘tamper-proof’, but now ‘tamper-resistant’ – can be removed in under 10 seconds, has undermined MLA support for the product’s rescheduling from S4 to S5 status.

MLA has funded more than $5.2m to develop Numnuts, including $3.8 million funded through the MLA Donor Company, for further R&D and to support commercialisation of the system’s applicator.

A NumOcaine bottle with its quick change cartridge.

An AWI spokesperson said AWI provided $76,500 for an early proof-of-concept collaborative project with MLA, plus a considerable amount of in-kind support and promotion.

“Following further investment from MLA for subsequent R&D, AWI’s final contribution was estimated to represent approximately 0.5 percent share in the total Numnuts R&D investment.”

Last year Numnuts creator Senesino director Robin Smith won Therapeutic Drugs Administration approval for rescheduling Lidocaine from S4 to S5 status on the Poisons Standard, potentially freeing NumOcaine up for retail and online sales without vet prescription, pending an Australian Pesticides and Veterinary Medicine Authority evaluation.

Numnuts’ creator Robin Smith.

However, the Australian Veterinary Association is appealing the TGA’s rescheduling amendment. The AVA has provided the regulator with a short video showing how with the help of hot water and a spoon, the tamper-resistant bottle cartridge specific to the Numnuts system can be removed, improving access to the contents.

Early last year, MLA’s then program manager for animal welfare and biosecurity, Johann Schröder, and AWI’s general manager, research, Jane Littlejohn, gave their full support to the proposed amendment to the Poisons Standard on TGA feedback forms.

However, in October last year Meat & Livestock Australia withdrew its support for the rescheduling after finding out the NumOcaine bottles are not tamper-proof. MLA managing director Jason Strong told Bendigo sheep vet Tristan Jubb that MLA’s submission to the TGA was made on the assumption that vials of NumOcaine are tamper-proof.

“It was the considered opinion that the rescheduling would ultimately provide for better animal welfare outcomes over time.

“It is now apparent that the vials are not tamper proof and it is on this basis that MLA intends to withdraw its submission to the TGA,” Mr Strong wrote.

MLA’s group manager – productivity & animal wellbeing, David Beatty, has confirmed that MLA has withdrawn its initial TGA submission and has informed the APVMA’s chemicals and medicines scheduling secretariat team.

“MLA’s ongoing position on the rescheduling discussion is that MLA supports initiatives that provide for better animal welfare.

“The responsibility for decisions associated with public safety and the potential for misuse of available pharmaceuticals lies with the regulating authorities such as the Australian Pesticide and Veterinary Medicine Authority (APVMA) and the TGA,” Mr Beatty said.

“MLA’s focus continues to be on delivering impactful research outcomes to industry through our on-farm R&D programmes.”

The AWI spokesperson said AWI supports an S5 status for NumOcaine and it has made a submission to the APVMA consultation process.

S4 status will mean reliance on veterinarians

On the initial TGA feedback form, Dr Schröder said: “Producer access to a local anaesthetic, in a tamper-proof vial that limits application to an appropriate rubber ring applicator, will allow castration and tail docking to continue as legitimate husbandry procedures, but with pain management, while less aversive alternatives (e.g. contraceptive vaccines) are being researched and developed.

“Failing to re-schedule lignocaine for this purpose will compel rural producers to depend on veterinarians that are often only remotely located, for access to prescription veterinary medicines,” he wrote.

“It is safe to assume that in such situations, most animals will not enjoy pain relief when subject to routine husbandry procedures.”

Vet oversight mitigates product risk

Dr Jubb has told Sheep Central he was hoping for a more definitive stance on the issue from MLA.

“What I was hoping was for them to say ‘we were wrong, we did not appreciate that it wasn’t tamper-proof’, but how could that be?

“They had such a big stake in the development of this device, how could they not make a re-usable device?”

He said anyone with strong hands can twist the NumOcaine-specific cartridge off, but there is even no need to remove the cartridge to gain access to the Lidocaine solution.

“All you need is to squirt enough out of the bottle (with the NumOcaine applicator) and suck it out with another syringe needle and go your hardest.”

The AVA has argued that giving Lidocaine/NumOcaine S5 status will make it more available for misuse, whereas Mr Smith believes the NumOcaine cartridge design specific to the Numnuts system and sale through rural sellers sufficiently mitigates abuse risk.

Dr Jubb said vet oversight enables demonstration of the product’s correct use and risks – toxicity and posterior paralysis — and verification of a user’s bona fides. This includes using a Phone A Vet app consult for existing clients before product is dispensed. Supply would cease if there was any abuse, he said.

“As soon as it goes online, all of that is gone – so it opens the floodgate.

“If it is bought online it could go anywhere and everywhere and there is no accountability – that’s really the major concern here,” he said.

“It’s a matter of the scale of availability and oversight.”

NumOcaine ‘tamper-resistant’ objection is a weak argument

Dr Schröder is now working as a private consultant, and said he still stands by his initial TGA statement and supports Lidocaine’s rescheduling to S5. He initially called the NumOcaine bottle cartridge ‘tamper-proof’ “because that’s what initially we were told it was” and he was subsequently told it should have been described as ‘tamper-resistant’.

He said use of either of the NumOcaine bottle descriptions is “quite relative”, because with his pocket plier-knife implement he is able to take the top off a standard S4 multi-dose Lidocaine bottle with its “so-called tamper-proof” crimped on rubber stopper closure within 17 seconds.

“So the objection that the tamper-resistant closure on a NumOcaine bottle is not tamper-resistant enough is a load of rubbish as far as I am concerned.

“I would say it is a weak argument.”

In his initial TGA submission, Dr Schröder said the community and consumer expectation is that producers should improve the wellbeing of the animals in their care, as shown in numerous MLA-funded consumer surveys over 10 years or more.

“Replacing painful with non-painful husbandry procedures is a big issue at the moment.

“Failing an alternative, refining current procedures, e.g. by administering some form of pain management, is a logical next step,” he said.

“Customised local anaesthesia in the form of a device/system such as Numnuts is a valuable innovation.

“Numnuts is not the complete or final answer, e.g. the duration of anaesthesia is too short, but it is a quantum leap from what was available before, which was nothing,” he said.

Dr Schröder said very few veterinarians have thus far involved themselves with the lamb marking process, doing pre-operative local anaesthesia, followed by subsequent analgesia.

“A large percentage of sheep producers are not regularly serviced by veterinarians, thus eliminating them from the process of adopting pain management more widely.

“For all the reasons above, a buccal formulation of an NSAID (only meloxicam currently registered for sheep in Australia) under S5 is also logical,” he said.

Sheep and wool bodies support S5 status for Lidocaine

WoolProducers Australia chief executive officer Jo Hall said the WPC stands by its original submission to the Therapeutic Goods Administration in support of the rescheduling of Lidocaine to make this product more freely available to wool growers.

She said the WPA also strongly opposes the AVA’s proposal that the current Schedule 5 listing of 2pc injectable Lidocaine (for use in lambs and calves) be removed from the Poisons Standard.

“The decision of the TGA, as published in September 2021, was thorough and supported the delivery of significant industry benefits through the increased adoption of the use of pain relief products when undertaking the prescribed husbandry procedures.”

Sheep Producers Australia acting chief executive officer Bonnie Skinner reiterated the SPA’s view that the availability of effective pain relief products is essential for Australian sheep producers in order to maintain high standards of animal welfare.

“Farmers require easy access to pain relief chemicals so that they and their contractors can undertake the necessary husbandry procedures to provide for good lifetime welfare outcomes, and this is why Sheep Producers Australia supported the product to be classified as an S5 in October 2021.

“Sheep Producers Australia firmly believes that the TGA made the right decision to reclassify the product to an S5 and to reconsider its earlier decision would be detrimental to animal welfare outcomes,” she said.

“Whilst no risk can be completely eliminated with regards to chemicals and poisons, Sheep Producers Australia believes the construction and design of the NumOcaine product and applicator makes the product difficult to abuse.

“Sheep Producers Australia queries why the proposed amendments to the Poisons Standard are being reconsidered by the TGA, given that the TGA made the decision on the current classification, and in light of the recent application providing no new information.”

Non-mulesed wool supply facilitator Peter Vandeleur from New Merino said the safe and effective Numnuts innovation to administer local anaesthetic to lambs for castration and tail docking is a huge step forward and will win support from animal welfare organisations that are keeping a critical eye on wool production practices in Australia.

“While we understand that in excess of one million doses have been safely administered by farmers, this represent only approximately 2pc of the lambs marked annually.

“We believe that one reason for this low adoption is that currently Lidocaine is only available through veterinary practices,” he said.

“This is inhibiting its uptake and hence limiting the animal welfare benefit as well as the opportunity to create a positive reputation for the Australian industry.”

RSPCA lends its support

The RSPCA Australia has also supported the rescheduling of Lidocaine, with senior scientific officer Melina Tensen arguing that this would allow greater uptake of the NumOcaine technology, “providing a significant welfare improvement for the millions of lambs and calves subjected to painful castration and/or tail docking each year.”

The NSW Poisons Information Centre at the Children’s Hospital at Westmead said its support for Lidocaine’s rescheduling is dependent on the product packaging being specific to a a device with a set dose of 1.5ml for injection.

“The bottle should not be substitutable into another injection device, which may allow injection of larger doses.

“Accidental doses of Lidocaine could pose a serious poisoning risk.”

HAVE YOUR SAY

Your email address will not be published.

Your comment will not appear until it has been moderated.
Contributions that contravene our Comments Policy will not be published.

Comments

  1. John Moffat, February 26, 2022

    A folly? Pain alleviation for routine animal husbandry procedures appeals to both farmers and consumers; however, the premise that any bottle or vial can be made tamper-proof is ludicrous.
    An individual with nefarious intent could gain access regardless of the “system”.
    This wasted funding and developer effort highlights flawed thinking and poor oversight.
    There is nothing special about NumOcaine. The same substance can be purchased for a fraction of the cost in 500ml plastic packs.
    To get this to farmers at a reasonable cost – hence greater uptake and animal welfare outcome — effort should have gone into developing a workable solution for prescribing the existing local anaesthetic for use in the Numnuts device.

  2. Tristan Jubb, Bendigo Sheep Vets, February 5, 2022

    It’s time to let the TGA decide. The AVA brought to the attention of the TGA and the APVMA that the NumOcaine bottles were not tamper-proof, not tamper-resistant, not tamper anything; something these organisations and MLA were not originally aware of. Giving S5 status to NumOcaine would be exactly like openly selling bottles of 2 percent lignocaine online to anyone in any quantity, to use for any purpose, with all the bad things that may bring. It is not veterinarians being greedy or driven by self-interest, it is that veterinarians deeply care about the welfare of animals and know exactly what people are capable of doing to themselves and their animals. The qualifications to own and manage animals are zero and veterinarians see the consequences of that every day. That is where we are coming from. Please be aware that the AVA has been working hard with the veterinary legislators to get some relief in the dispensing rules for management medications such as Metacam, Buccalgesic, NumOcaine and ram sedative to ease farmer access. Let a fully informed TGA now decide.

  3. Al Hort, February 4, 2022

    I’ve experienced total frustration trying to get NumOcaine from the vet. The first vet nurse I saw said: “No, I couldn’t obtain and use it as it was restricted”. The second and third time I rang the nurses failed to pass on my request to the vets. The fourth time I went into town again and saw a nurse I knew and told her my frustration. Three days later a vet rang me and we debated the need for a call-out fee as he wanted to see the farm. The call-out fee was more than the cost of the NumOcaine. We had been using this vet regularly for dogs, cats, horses and sheep. Another few days later the vet rang and said he would supply it without a call-out fee and visit. I ordered five bottles expecting to do around 280 injections. It was a week from when the vet spoke to me when I got a call that the NumOcaine had arrived. Five weeks, three trips to town and five phone calls and nearly double the price if I was adding the call-out fee. It was enough to stop me ever using it again, which is wrong on every level considering what a brilliant device the Numnut applicator is in conjunction with NumOcaine.

    Nutrien, Yolla Coop or Elders usually have vaccines etc. in stock or can check stock at any store in Tasmania. They then send what I need to a local store within a day where I can pick it up or they will drop it off along with other deliveries free of charge. Very different process to the vets.

    I agree with Frank Eagan and Fiona Hill. Also I am finding that small producers like myself are being squeezed out of farming so the “corporate farms and big business” can take over. The organisations supposed to help and support us do nothing of the sort. Its all about big money.

    Also I will add for the benefit of Erica Kennedy that my 3 farm dogs and stock horse get better medical care than I probably give myself!!! They are worth more to me than half a dozen human workers so they won’t be getting abused with Numocaine any time. I fail to see Erica why getting Numocaine from the vet or from the rural supplier makes any difference to it being abused. The abuse will occur regardless of the supplier. In fact the rural supplier knows more about me, my farm and my animals than any vet ever will so the bigger risk of abuse comes from being supplied by a vet.

  4. Marcus James, February 4, 2022

    Shame on the MLA for selling out its members for a small group a self-interested of vets.

    This is should outrage every levy-paying MLA member, having taken the forward thinking decision to invest our levy dollars into a vital development that farmers wanted, enabling them to practically deliver pain during lamb marking.

    This is an advancement critical to meeting the sustainability challenges of our industry and keeping us internationally competitive in a market constantly raising the animal welfare bar. And MLA finally had success in actually delivering … for once.

    MLA has now inexplicably bowed down to the Australian Veterinary Association’s lobbying and concocted concerns. It doesn’t take blind Freddie to see that the AVA is more concerned with protecting its own vested interest in the profits its members make on the monopolistic access to selling NumOcaine rather than animal, or for that matter, human welfare.

    MLA should be standing up for us, its members, and our support for the investment in Numnuts, not actively undermining the millions of dollars we have invested and positive impact it has, so vets can make more money.

    Not only is MLA protecting vets’ incomes over access and uptake of Numnuts by members, the MLA leadership is actively sabotaging our investment in the technology and future possible returns. Maybe they should be called the MLAVA?

    This is nothing short of a deliberate and disgraceful disregard for MLA members and our levies. Shame, shame, shame.

  5. Tim Leeming, February 3, 2022

    As a farmer and like a growing number of farmers who want to improve their animal welfare on farm, I am disappointed to see any delays or accessibility to a fantastic product in Numnuts. Being one of the first sheep flocks in Australia to utilise this product and to see first-hand the fantastic outcomes in reducing acute pain in our animals, I have been very keen to see a rapid uptake across industry. Keeping in mind the Meat Industry Strategic Plan, we understand the massive downside risks associated with not addressing animal welfare. Like many producers we have pushed from the grassroots level to set priorities in industry in this space, to make our red meat industry front footed in relation to meeting consumer expectations. These initiatives maintain and establish market access and should be fast-tracked or not hindered. Momentum is all important and all good business needs to be proactive. The horse will bolt in this space if we become laggards. Get it resolved and push on with more pain relief now.

  6. Fiona Hill, February 2, 2022

    As a rural retailer, our clients find it very convenient to buy their Numnuts application device through us, but an absolute inconvenience to travel four times as far to visit the vet to pick up their supply of NumOcaine to go in the device. What’s to stop our client doing so-called “DIY cow ceasareans” (Comment from Erica Kennedy Feb 1) with the NumOcaine they collect from the vet anyway? A ludicrous suggestion that our clients would abuse the drug if they purchase it from our rural retail outlet and take it back to their farm, but use it according to label if they purchase it from a vet and take it back to their farm. Under our Agsafe premises’ accreditation and Schedule 7 Retail Licence for S7 Dangerous Poisons, we are required to know how to read labels and communicate to farmers the correct and safe use of APVMA-approved products….. just as vets do under their respective licence.

  7. Erica Kennedy, February 1, 2022

    Imagine how many farm dogs will suffer when their owners decide to use lidocaine and stitch them up instead of taking them to the vet? Or how many DIY cow caesareans and epidurals will be performed?
    People do pretty wild things now without local anaesthetic, imagine what they may try with it?

  8. Frank Egan, January 31, 2022

    Another example of big money/business overriding the benefits to the farmer after we, the farmers, funded it in the first place.

Get Sheep Central's news headlines emailed to you -
FREE!