Proposed rescheduling of medications – oral meloxicam and injectable lidocaine – submissions due 31st January 202212 Jan 2022
In late December 2021 the Therapeutics Goods Administration (TGA) proposed amendments to the Poisons Standard, for discussion in March 2022.
There are two amendments that are relevant to the veterinary profession: meloxicam and lidocaine, and we have a working group in place, involving a number of subject matter experts and special interest groups, to develop the AVA and associated special interest group submissions around these amendments. We encourage individual members to comment on these amendments as well by submitting a response on the TGA website.
When asked in your submission, please respond as an individual. This can be done through accessing the SUBMIT YOUR RESPONSE tab on the consultation hub on the TGA website. The submission requires you to include
- If you do or do not support or have no opinion about each amendment (there are more amendments than meloxicam and lidocaine)
- If you have a supporting statement to make (this can be a pdf or written in an online comments box). We have drafted some points that you may want to consider including, based on the AVA’s position for each drug.
Item 2.3 Meloxicam
The proposal is to create a new Schedule 6 entry for meloxicam that captures oral transmucosal preparations, at up to 1 per cent concentration, for pre-surgical treatment and pain management during routine animal husbandry procedures. The new entry would allow access to meloxicam without a prescription for pain relief in animals undergoing these procedures.
This would mean that an oral formulation of meloxicam (currently S4, and thus prescription-only) would be available over-the-counter for anyone to access.
The AVA is opposed to this amendment and does NOT support item 2.3 meloxicam as it provides opportunity for uncontrolled use of a potentially dangerous drug in a broad number of species, including humans. We have emphasised the public health risks that this poses, as this is a particular focus of the TGA, and we encourage you to similarly emphasize this point.
Further information to support the AVA’s position which you may find useful to include can be found below under the heading Meloxicam – supporting evidence to oppose the amendment.
Item 2.4 Lidocaine
The AVA has strongly opposed the recent rescheduling decision in October 2021 to schedule “lidocaine in injectable preparations containing 2 per cent or less of lidocaine when packaged in a container with a tamper resistant cartridge which can only be dispensed through a rubber ring applicator for tail docking and castration of lambs; or castration of calves” as S5. AVA submitted an application to the TGA for this to be re-evaluated and reversed, and we have been successful in having that application tabled for consideration. They are now requesting comments around this proposal.
As the applicant, the AVA FULLY SUPPORTS “item 2.4 lidocaine”, removal of the recent inclusion of injectable lidocaine to S5, so all injectable lidocaine preparations are S4 only. This removes the opportunity for uncontrolled use of a potentially dangerous drug in a broad number of species, including humans. We have emphasised the public health risks that this poses, as this is a particular focus of the TGA, and we encourage you to similarly emphasize this point, along with the significant animal welfare concerns with use without veterinary oversight and misuse of this product.
Further information to support the AVA’s position which you may find useful to include can be found below under the heading Lidocaine– supporting evidence to support the amendment.
Meloxicam – supporting evidence to oppose the amendment.:
To address relevant matters mentioned in section 52E of the Therapeutic Goods Act 1989:
The risks and benefits of the use of a substance
Meloxicam is a potent short-acting nonsteroidal anti-inflammatory drug (NSAID) which is commonly prescribed in many species as an analgesic and anti-inflammatory. It is an excellent drug to manage inflammation and pain when given at the appropriate dose and duration to suitable patients. However, there are known risks associated with its use in humans and in animals and for this reason meloxicam is currently regulated as a prescription-only medication in Australia, the USA, Canada, New Zealand, UK, Ireland, and Europe due to safety considerations.
For animal patients, veterinary knowledge is important 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. Therefore, it is critically important that meloxicam remains a Schedule 4 (prescription only) medication.
The purposes for which a substance is to be used and the extent of use of a substance
Meloxicam is used to reduce pain during husbandry procedures in animals and to manage inflammation and pain associated with disease processes or injury. It is commonly supplied by veterinarians in either injectable or oral (buccal) form to farmers to use in sheep and cattle undergoing painful husbandry procedures. Veterinarians fully support and encourage increased use for this purpose, particularly when used as part of a multimodal analgesic approach.
Note that transmucosal meloxicam will not be effective if administered inappropriately. For it to work effectively it needs to be administered onto the mucous membranes of the mouth. A common mistake is administration onto the tongue like a drench, which means the product is swallowed and not absorbed correctly, and pain relief is not achieved, resulting in poor animal welfare outcomes. This mistake can be avoided when a veterinarian’s knowledge and advice are imparted to a farmer during the prescribing process.
The applicant has not demonstrated a persuasive need to reschedule meloxicam by transmucosal route to make the drug more accessible. There is absolutely no impediment to supply through veterinarians. Veterinarians can supply S4 medications such as meloxicam by telemedicine or other remote means, once an initial relationship with the client and knowledge of their flock has been established.
The toxicity of a substance
Meloxicam dose rates vary from species to species. Administration at inappropriate doses can be associated with significant adverse effects in a range of body systems including the renal, gastrointestinal and haemopoietic systems. If meloxicam is given to diseased animals the risk of adverse effects is even higher. The literature provides copious evidence that these adverse reactions can be fatal. Given the toxicity risks, administration to animals needs to be under strict veterinary direction.
Further, there is potential for significant human toxicity if the product is accidentally or deliberately misused. There are currently 71 human products containing meloxicam (all S4 prescription-only). The associated Consumer Medicine Information documents summarise the safety and toxicity issues and the need for cautious use. These include potential adverse cardiovascular events, risks for children, people with liver and kidney problems, gastrointestinal ulceration, interactions with other drugs including antihypertensives, immunosuppressants, diuretics and alcohol, and use in pregnancy or while lactating.
The risk of rescheduling the veterinary transmucosal product to S6 is that it will become a readily available and inexpensive substitute for the human prescription-only products: there is a very real likelihood of this product being taken by the oral route in humans, with serious adverse health outcomes, as has been associated with other veterinary products such as ivermectin.
It is noted and highly relevant that in 2005 the TGA introduced stricter measures around the prescribing of Cox2 Inhibitors including meloxicam following the findings of a review into the safety of this family of medicines.
The dosage, formulation, labelling, packaging and presentation of a substance.
It is essential that this transmucosal veterinary meloxicam product, given its potential toxicity and potential for misuse, is only prescribed by veterinarians, as this requires the addition of a specific label giving directions for use. This will mitigate the risks of: accidental overdosage; use where it is contra-indicated; and misuse in other species, including humans. Furthermore, unlike the situation for use of S6 products, veterinarians must keep records of use of S4 medications, and this record can help in investigations of supply, appropriate use, and adverse effects.
The potential for abuse of a substance
Veterinarians must establish a genuine vet-client-patient relationship prior to supplying S4 medications. Supply of meloxicam by veterinarians requires them to have knowledge of the animals owned by the client. Supply under veterinary direction also ensures this product is not used inappropriately in other species, including humans. Should this product be rescheduled to S6 however, it could be supplied to anyone over the age of 16 from any wholesale, retail, or online outlet, without the need to establish actual ownership of livestock, or any genuine justification for obtaining the medicine.
(i) Potential for abuse in animals:
If rescheduled such that it is available over-the-counter, it is highly likely that it will be used inappropriately in other animal species:
- For example to treat sick or injured companion animals, with a high likelihood of toxicity due to incorrect dose calculation, or use in conjunction with other contraindicated medications.
- It may be used to mask pain in racing horses and greyhounds, or to mask pain in livestock that are otherwise unfit for transport – all of these pose unacceptable animal welfare risks.
- Misuse in performance animals without appropriate diagnosis by a veterinarian, particularly in the case of lameness or gait abnormalities in horses, poses a risk of serious injury to the rider if the horse has a catastrophic fracture of a masked prior injury, as has been reported in the past both in Australia and overseas.
- Inappropriate dose rates and withholding periods in both target and non-target food species poses an unacceptable risk of the drug entering the human food chain through residues in meat and other animal food products. Misuse to mask pain in livestock prior to transport to abattoirs for slaughter poses a similar risk. This could compromise Australia’s food safety and impact our export industries worth billions of dollars to the economy.
- The medicine might be used to mask inflammation and clinical signs in animals suffering from undiagnosed infections – this poses a very real biosecurity risk, including the risk of serious zoonoses going undetected, and all the associated risks to public health
(ii) Potential for abuse in humans:
- The risk of rescheduling the veterinary product to S6 is that it will become a readily available and inexpensive substitute for the human prescription-only meloxicam products, because it would be obtainable without the inconvenience of arranging a medical consultation to procure via script.
- Thus, there is a very real possibility of this product being taken by humans, with adverse health outcomes – we have witnessed this type of behaviour only recently with abuse by humans of other veterinary products such as ivermectin.
- There could be significant risks to humans if used in combination with other NSAIDs and corticosteroids, as well as through continued use when signs of toxicity which go undetected. Further, overdosage is possible in people unaccustomed to calculating dose rates, particularly when extrapolating from a veterinary preparation to take in oral form. Of course, the label contains no directions to the human consumer (no CMI or PI).
Lidocaine– supporting evidence to support the amendment.
Reasons that the AVA provided to support the case for reconsideration are as follows:
The application by the AVA expresses concern regarding the “tamper-resistant” condition placed on packaging of Schedule 5 preparations of lidocaine, as this can be circumvented by dispensing of the solution into a vessel to be used for purposes other than those specified in the Schedule 5 entry. These risks are manageable under a Schedule 4 listing. It should be noted that the Numnuts applicator dispenses the lidocaine through a needle which is positioned in conjunction with a rubber ring applicator, rather than being dispensed through the rubber ring applicator - as is required by the current S5 entry.
Misuse of lidocaine poses public health risks, including as an unregulated anaesthetic by illegal “body modifiers”, in the dilution (“cutting”) of cocaine by illicit drug manufacturers, and as a suicide agent.
There is also concern regarding animal welfare, with the prospect of lidocaine being used as a masking agent in performance animals or to perform painful acts of veterinary science, with very poor animal welfare outcomes. An example of this is the recommendation within the Numnuts FAQs for use of the rubber ring applicator on calves greater than 2 weeks of age and up to 2-3 months of age, which is considered unacceptable practice from an animal welfare perspective and contravenes guideline G6.16 in the Cattle Animal Welfare Standards and Guidelines. In fact, there is footage online for promotional purposes, showing use of this applicator on very mature calves up to 178kg – this is unacceptable from an animal welfare perspective. Other examples of potential abuse of lidocaine by people who are not veterinarians are: cattle producers attempting epidurals to correct the commonly occurring vaginal prolapse in Bos indicus cattle; lay persons using lignocaine to desensitise testicles in unsedated colts to castrate them; lay persons suturing wounds in farm animals and dogs (ie pig dogs).
Access to lidocaine for use by farmers on livestock to undertake the husbandry procedures of tail docking and castration of lambs using a rubber ring, or the castration of calves using a rubber ring 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. For this reason AVA strongly supports rescheduling of this product to S4.
Further information that you may wish to use to draw on can be found in the application for reconsideration