'Off-label' drugs, compounded medicines and antibiotics


'Off-label’ use of drugs

‘Off-label’ prescribing is writing a prescription or authorisation to a client to allow them to use a registered drug or veterinary chemical in a manner contrary to the approved label directions – type of animal, dosage, treatment interval etc. This must not be contrary to a specific label restraint.

Veterinarians are permitted to exercise professional judgement in the ‘off-label’ use or supply of most drugs or other veterinary medicines. This gives veterinarians access to beneficial drugs which may be registered for human use or which have limited registration for veterinary use. However, veterinarians must be aware that access to such drugs is the subject of concern in the community, and that misuse of such drugs may lead to withdrawal of this authority. The client needs to be aware that this is off-label use and this recorded in the patient’s record.

A number of legal limits have been placed on the ‘off label’ prescribing of drugs by veterinarians under national control-of-use principles adopted by most States/Territories. These primarily relate to treatments for defined food producing species, and are less stringent for companion animals. In most jurisdictions use of any product for companion animals is permitted, but supply is usually restricted to human pharmaceuticals or products compounded by the veterinarian or on their prescription.

Responsible use of compounded medicines

Compounded pharmaceuticals are unregistered veterinary medicines that form an important part of a veterinarian’s arsenal in treating their patients. Unlike registered veterinary medicines, they are not subject to rigorous assessment for product quality, efficacy and safety by the Australian Pesticides & Veterinary Medicines Authority (APVMA) and therefore may carry a greater risk than registered products when used to treat animals. As with all medicines, veterinarians must understand and comply with all legal requirements for preparation and use of compounded medicines in accordance with national, state and territory control of use and drugs and poisons legislation. You should familiarise yourself with the AVA Guidelines for the prescription and use of compounded medicines.

Responsible use of antibiotics

To help minimise the emergence and dissemination of antimicrobial resistance it is the responsibility of all veterinarians to dispense and use antimicrobials responsibly.