Oxytetracycline rescheduling – submissions due 5 February 2024

The TGA has released a pre-meeting public consultation on proposals to amend the Poisons Standard - there is a proposal to amend the scheduling of oxytetracycline. 

An applicant has submitted an application to the TGA to amend the Schedule 5 entry for OXYTETRACYCLINE to include topical preparations to treat superficial skin infections.  

The proposed change would mean that topical preparations of oxytetracycline for use in superficial skin infections (currently S4, and thus prescription-only) would be available over-the-counter and online to the public, to be used without veterinary oversight. The main reason the applicant has given for the proposed rescheduling is to allow topical treatment of footrot, other foot infections and superficial skin infections in livestock, without the need for a veterinary prescription.

The AVA is preparing a submission to OPPOSE this amendment. We also encourage individual members to comment on these amendments as well by submitting a response on the TGA website by 5 February 2024.  

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 oxytetracycline).
• 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.

The AVA shares the opinion of the ACVIM that “all antimicrobials intended for use in animals (excluding ionophores) should be available only by prescription by a veterinarian with a valid veterinarian/client/patient relationship. Over-the-counter (OTC) access to antimicrobials from sites such as feed supply stores or pet stores is contrary to basic concepts of prudent and effective antimicrobial stewardship and could constitute an animal welfare concern if sick animals do not receive proper veterinary care.”

• Poor antimicrobial stewardship increases risk to public health 

Increasing over-the-counter (OTC) availability of any antimicrobial, irrespective of classification, demonstrates poor antimicrobial stewardship. Reducing OTC availability of antimicrobials is a priority action of the World Health Organisation global action plan on antimicrobial resistance.  

A recent joint summit noted the global prevalence of over-the-counter antibiotic sales and the associated risks of antimicrobial resistance (AMR). It highlighted the complex transmission mechanisms of AMR among animals, humans, and through food, water, and environmental contamination as well as the potential for rapid spread of AMR across boundaries.

The summit observed the role of antimicrobial overuse as a major driver of resistance, linked to health systems, demand, supply and industry factors. The summit discussed the importance of legislation in creating an enabling environment for phasing out the over-the-counter sale of antimicrobials.

The applicant to the TGA in this case states:

• Oxytetracycline is not considered to present a significant risk in the development of antimicrobial resistance in the treatment of infections in humans.
• Oxytetracyclines are used in human therapeutics and are classed as antibiotics of low importance.
• Topical oxytetracycline absorption is negligible and the drug acts via direct contact with bacteria on the skin and in superficial lesions on external body surfaces.

AVA opinion: These statements demonstrate a disregard for the importance of antimicrobial stewardship, lack of understanding of the complexities of the development of AMR, particularly the involvement of environmental contamination.

• Animal welfare concern

The main principles of good antimicrobial stewardship include preventing disease occurrence, and when disease is present, appropriate antimicrobial use, both of which require veterinary expertise to implement. Adherence to these two principles also results in improved animal welfare outcomes.

The applicant to the TGA in this case states “Topical veterinary applications of oxytetracycline are used in the treatment of foot rot in sheep, digital dermatitis in cattle and superficial skin infections caused by oxytetracycline sensitive organisms in pigs, sheep and cattle”. 

AVA opinion: The majority of superficial digital dermatitis infections in animals (the purpose of this preparation) are more appropriately managed with other treatments that do not involve topical antimicrobials. Failure to implement these treatments is likely to result in poorer animal welfare outcomes. By removing the requirement of veterinary involvement in the access to topical oxytetracycline, increased pain and suffering could occur as the drug may not be the appropriate treatment, or may be applied incorrectly without due attention being paid to the requirement to remove debris and abnormal tissue, or the need for systemic treatment. Appropriate treatment may be delayed due to a delay in seeking veterinary attention.

The applicant states “Oxytetracycline is a broad-spectrum bacteriostatic antibiotic that is effective against a wide range of Gram-positive and Gram-negative bacteria. Direct access to oxytetracycline benefits farmers when they do not have veterinarian access and could serve as a first line defence against superficial infections.”

AVA opinion: Compared to some other countries Australia has a high level of access to veterinary expertise, and there is no impediment to supply through veterinarians. Whenever use is indicated, veterinarians can supply S4 medications by telemedicine or other remote means, once an initial relationship with the client and knowledge of their flock or herd has been established. With effective transport services the rapid provision of product is possible even for the most remote properties.

• Biosecurity and Emergency Animal Disease risks

The applicant has specified that topical application is used in the treatment of foot rot in sheep, digital dermatitis in cattle and superficial skin infections caused by oxytetracycline sensitive organisms in pigs, sheep and cattle. One of the emergency animal diseases of most concern to Australia is Foot and Mouth Disease (FMD). Dermatological diseases localised to the feet of these species are a differential diagnosis for FMD. Reducing veterinary oversight of these diseases could result in a delay in diagnosis of an FMD incursion into Australia, which would have a huge animal welfare, economic and social impact.