Proposed rescheduling of medications - Meloxicam29 Sep 2021
On September the 7th 2021 the Therapeutics Goods Administration (TGA) proposed amendments to the Poisons Standard, due for decision in November 2021. Of concern to the veterinary profession is the proposed amendment to meloxicam.
The proposal is to create a new Schedule 6 entry for meloxicam that captures injectable preparations, at up to 2% concentration, for the pre-surgical treatment of sheep undergoing husbandry procedures.
This would mean that injectable 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 has 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 against the proposed amendment.
We encourage individual members to comment on this amendment as well.
- 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 information as below (in bold). We have drafted some points that you may want to consider including, based on the AVA’s position.
You will be asked:
Whether or not you support the amendment/s – The AVA does NOT support the amendments 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.
Re: proposal to reschedule meloxicam:
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. Importantly, for animal patients, veterinary knowledge and oversight are required to prescribe appropriately and mitigate these risks. These risks are further outlined below. Therefore, it is critically important that meloxicam is a Schedule 4 (prescription only) medication in all of its current forms (for both human and animal use).
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 also 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 undergoing painful husbandry procedures. Veterinarians fully support and encourage increased use for this purpose.
The applicant has not demonstrated a persuasive need to reschedule meloxicam by injection to make the drug more accessible. There is absolutely no impediment to supply through veterinarians. Veterinarians are able to 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. 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 injectable 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 Cox-2 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 injectable 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 sheep flock 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, any person will be able to buy this via online pharmacies or over-the-counter, for their own use, without any need to demonstrate ownership of sheep or any genuine justification for obtaining the medicine.
Furthermore, if rescheduled it is likely that it will be used in animals in preference to other more appropriate drugs, due to ease of access. It may be used without veterinary consultation to mask pain in animals that are otherwise unfit for transport, or other activities such as racing, and this poses an unacceptable animal welfare risk. It may be used to mask pain in animals prior to transport to abattoirs for slaughter, allowing the drug to enter the human food chain. 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 human health.
Any other matters necessary to protect public health
- As outlined above, if listed as a Schedule 6 substance, this product could be supplied to anyone over the age of 16 from any wholesale or retail (or online) outlet, without the need to establish actual ownership of sheep, without any veterinary oversight and advice on the risk of harm. The risk is that it will become a readily available and inexpensive substitute for the human prescription-only meloxicam products; there is thus a very real risk of this injectable product being taken by the oral route in humans, with serious adverse health outcomes.
- Overdosage is possible in people unaccustomed to calculating dose rates, particularly when extrapolating from an injectable veterinary preparation in order to take in oral form. Of course, the label contains no directions to the human consumer (no CMI or PI).
- There are public health risks if used in combination with other NSAIDs and corticosteroids, and continued use when there are potential signs of toxicity.
- If used inappropriately in the target species, or other animal species, there is risk of masking infectious disease and thus delaying or failing to identify serious biosecurity and zoonotic risks. Further there is risk of contamination of the human food supply through inappropriate use.
- If misused in performance horses without appropriate diagnosis by a veterinarian, particularly in the case of lameness or gait abnormalities, there exists a real risk of serious injury to the rider if the horse has a catastrophic fracture of a masked priori injury, as has been reported in the past both in Australia and overseas.
- The AVA does not believe, given the serious toxicity and other adverse outcomes that could occur as a result of misuse, that label warnings, safety directions or even child-resistant packaging will prevent intentional misuse of this product in the ways we have described.