Submission to the TGA regarding Oxytetracycline rescheduling

05 Feb 2024

The AVA prepared a submission to not support the amendment to the Schedule 5 entry for OXYTETRACYCLINE in preparations to treat superficial skin infections, as 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 AVA does NOT support the amendment for several reasons:

  • 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.
  • Increasing Over the Counter (OTC) access to antimicrobials contravenes contemporary standards of practice and antimicrobial stewardship principles and contributes to antimicrobial resistance (AMR) with potential harm to public health.
  • Animal welfare implications – Responsible use of oxytetracycline is essential as it is an important first line antimicrobial for infectious diseases across a number of species including many life-threatening infections.  Topical oxytetracycline is uncommonly used in contemporary practice for the treatment of superficial digital dermatoses in animals. 
  • Biosecurity and Emergency Animal Disease risks are increased when veterinary oversight of veterinary medicines are removed and accurate diagnosis is not made.
  • The applicant has not demonstrated a persuasive need to reschedule oxytetracycline to make the drug more accessible.  There is no current impediment to supply through veterinarians.

Furthermore, the applicant has provided two reasons for therapeutic need that we address as follows:

APPLICANT REASON FOR RESCHEDULE

AVA POSITION

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.

For topical infections the recommended first line of defence is provided by antiseptic and other preparations designed specifically for the cleaning and disinfection of superficial wounds.  Antibacterial agents such as oxytetracycline are reserved for more serious wounds and superficial infections which are not expected to respond, or have not responded, to simple cleaning and antisepsis.

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.

Topical preparations of OTC are used as a prescription animal remedy following appropriate diagnosis.  For example, the management of footrot in sheep requires complex and ongoing planned interventions where topical OTC is but one of many management and therapeutic options available.

 

Read more here.