AVA Submission on the Proposed amendment to the Poisons Standard - 3.3 Meloxicam Oral Transmucosal Preparations

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has submitted an application to create a new Schedule 6 entry for MELOXICAM in oral transmucosal preparations containing 1 per cent or less meloxicam for pre-surgical treatment and pain management during routine animal husbandry procedures.

The proposed change would mean that transmucosal meloxicam (currently S4, and thus prescription-only) would be available over-the-counter and online to the public, to be used without veterinary oversight.

The AVA does NOT support the amendment for several reasons:

• Unrestricted access to oral meloxicam provides opportunities for uncontrolled use of a potentially dangerous drug in a broad number of animal species, which may lead to significant harm.
• This product has the potential to be abused by humans, and thus poses a public health threat if available in an unrestricted manner.
• Inappropriate use without veterinary advice in target and non-target species poses risks not only to animal health and welfare, but also to human food safety, biosecurity, and public health.
• Incorrect administration without veterinary advice may negate the analgesic effects of the medicine, leading to poor animal welfare outcomes.
• Veterinary knowledge is important to meet label requirements 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.
• Meloxicam is currently regulated as a prescription-only medication in Australia, the USA, Canada, New Zealand, UK, Ireland, and Europe due to safety considerations.
• It is noted 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 applicant has not demonstrated a persuasive need to reschedule transmucosal meloxicam to make the drug more accessible. There is no current impediment to supply through veterinarians. 

Read the full submission here.