News

Vets win interim TGA decision on meloxicam

Terry Sim, March 16, 2022

Metacam 20mg/ml injectable

AUSTRALIAN veterinarians have seemingly won the first round in their battle to resist wider prescription-free access to important pain relief medications for sheep and cattle.

The Therapeutic Drugs Administration’s Advisory Committee on Medicines and Chemicals Scheduling and a TGA Delegate have sided with the Australian Veterinary Association in opposing the rescheduling of injectable meloxicam from S4 to S6 on the Poisons Standard.

The rescheduling of injectable meloxicam at up to two percent concentration — currently marketed by the German-based company Boehringer-Ingelheim as Metacam — would have meant the product could be sold without the need for a veterinary prescription.

A statement on the AVA website said the TGA’s interim decision on injectable meloxicam came after a hard-fought campaign, led by the AVA and its members, opposing the proposed rescheduling.

“There were a total of 333 public submissions; of these 309 were opposed to the rescheduling.

“The submissions by the AVA and the special interest groups of the AVA, along with the Racing Australia submission were specifically noted as having influenced the TGA’s decision,” the AVA statement said.

The TGA’s interim decision was listed on its website on 10 March, but was made at a meeting in November last year. The AVA said the TGA’s decision specifically noted many of the risks that were identified by the AVA.

“It was acknowledged that removal of veterinary oversight has the potential to increase adverse events, including risks associated with diversion of use to species other than sheep.

“The TGA also noted AVA’s argument that there are no significant barriers to accessing meloxicam for veterinary use that need to be addressed by rescheduling,” the AVA said.

“We would like to thank the AVA volunteers on the working group who have represented your committees, and contributed to the design and execution of this advocacy campaign. They worked tirelessly on this campaign, as well as the two other veterinary medicine campaigns that we are still awaiting decisions on.”

The AVA has also appealed an earlier TGA decision to reschedule the lamb pain relief drug NumOcaine/Lidocaine from S4 to S5 status and is also opposing a proposed TGA amendment to the Poisons Standard to make oral transmucosal preparations of up to 1 per cent Meloxicam concentrations for pre-surgical animal treatment and pain management from Schedule 4 to Schedule 6 status to allow access without a prescription. Oral-form Meloxicam as Ilium Buccalgesic OTM is used for calf castration and dehorning or in lambs for castration, tail docking and mulesing.

Sheep Central believes the TGA committee has deliberated on the proposed rescheduling of NumOcaine/Lidocaine and Buccalgesic, but the AVA believes notification of the decisions is not expected until June this year.

Meloxicam rescheduling has potential to increase adverse events – TGA

The TGA Delegate found that the removal of veterinary oversight via a Schedule 6 classification for injectable meloxicam has the potential to increase the number of adverse events associated with the substance.

TGA Delegates decide on whether or not to approve a medicine for supply in Australia. They are typically senior officers in the TGA’s Prescription Medicines Authorisation Branch.

“I agree with the committee that there are no significant barriers to the access of meloxicam for veterinary use that would be addressed by creation of a new Schedule 6 entry, as preparations of meloxicam are presently available at low cost with a valid prescription.

“I also note that meloxicam continues to be regulated as a prescription-only medicine in all major international markets, including the USA, UK, Ireland, Canada and New Zealand,” the TGA Delegate said.

“The rescheduling of meloxicam in any form would therefore be out of alignment with regulatory controls that are in place in these countries.”

The Delegate said the rescheduling of injectable meloxicam should also include preparations presenting lower risk of needlestick injury, or else the scheduling remaining unchanged.

“With regards to section 52E(1)(e) of the Act, I have doubts regarding the implementation of the proposed changes, in particular the potential for diversion to animals other than sheep for purposes other than those specified in the Application.

“The potential for intentional or inadvertent misuse of meloxicam under a Schedule 6 classification is significant, and given the toxicity profile of the substance, poses an unacceptable risk to animal welfare,” the delegate said.

“I have also considered the potential for diversion of veterinary preparations of meloxicam to humans; however, deem this to be less likely as preparations for human use are readily available.”

The Delegate considered 232 written submissions received in response to the pre-meeting public notice, the majority (229 out of 232) of which were opposed to the application.

Broader pain relief access supported by producers

Boehringer Ingelheim Animal Health Australia said it is important to understand that it was not proposing to to reschedule all products containing meloxicam.

“Instead, the company has proposed an additional product entry into the S6 schedule specifically for injectable meloxicam products labelled to deliver pain relief to sheep undergoing common husbandry procedures that do not require veterinary intervention,” the company said in a statement.

“The proposal for broader access to effective on-farm pain management solutions is widely supported by peak sheep producer organisations and farmers.

“The S6 scheduling would allow Boehringer Ingelheim Animal Health to deliver comprehensive direct-to-farmer information and education about the role of injectable pain relief on-farm which is currently restricted by law,” the company said.

“This would support further adoption of best-practice animal welfare management in Australia.

“In this proposal veterinarians will continue to play a critical leadership role in animal wellbeing on-farm.”

The company said while there is no doubt that animal welfare outcomes have improved in recent years, with 41 percent of wool growers reporting the use of analgesia and/or anaesthetic when undertaking common husbandry practices such as mulesing, further progress can be made in broadening access to on-farm pain management products and education.

Boehringer Ingelheim Animal Health Australia will make a further submission to the TGA in relation to the interim decision.

“Boehringer Ingelheim Animal Health Australia will respond to the regulatory authority and continue to work closely with all stakeholders over the coming months.

“We expect a final decision later in 2022,” the company said.

Metacam® 20 was first registered for cattle in Australia 19 years ago, making Metacam® a well-known brand in the agricultural veterinary space. Metacam® 20 was registered for sheep in the Australian market in 2016, providing veterinarians with an innovative, long-lasting solution for pain relief for routine husbandry procedures, Boehringer Ingelheim Animal Health Australia said. Metacam® 20 is an NSAID given in a single intramuscular injection for sheep 14 days and older. It starts working within 10-15 minutes, and the pain relief lasts up to 72 hours, the company said.

Click here to read the full TGA interim decision on injectable meloxicam.

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Comments

  1. George Stefla, March 17, 2022

    This is a win for no one, especially not livestock. With the veterinarian industry being critical short and unable to service many regions as well as the need to get a prescription for a procedure that doesn’t require a vet is a joke. This doesn’t include the $200 visit for them to say yes you have sheep not to view or ensure any type of compliance is just a cash grab from vets looking to cash in on improved livestock prices. As a former American producer, the TGA is being a little loose with their interpretation of other countries. We could still be informed of new products available to be prescribed directly and vets were not allowed to sell drugs they prescribed because it is anti-competitive so we went to animal pharmacies like you do with a doctor. Vets are trying to clip the ticket for a job they don’t do with a notepad they haven’t earned. It is evident that if there was more than we could do for our animals because Metacam is 15 years old why are we just hearing about it now?

  2. Deb Maxwell, March 16, 2022

    It should not be thought of as a “win” for vets or that they have “sided” with AVA. It’s the right decision to prevent the product from being misused, and pets in particular from being wrongly treated. Vets are not trying to make life harder or more expensive for farmers, they want to ensure these type of products are used properly, with minimum risk and abuse by providing guidelines when they are dispensed. For instance, the concentration of meloxicam for sheep is 13 times that for dogs. Imagine people giving a lamb dose to a dog? A bit like continual overdosing on aspirin has a severe effect on people. And it’s not some general pain killer; not all animals should receive this product for pain.

    • Lachlan Gall, June 18, 2022

      “Vets are not trying to make life harder or more expensive for farmers” … and yet that’s exactly the outcome of this decision.

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