Extra Label Drug Use

This article outlines what you need to know when a veterinarian prescribes extra-label medications and compounded prescription drugs for the benefit of your pet.

Extra label drug use (ELDU or “off-label use”) is the use of any drug, whether it is a prescription drug or over-the-counter (OTC) drug, in a manner that is different from the label (package insert) approved by Health Canada. Compounded drugs are extra-label customized prescription medications created by a pharmacist or a veterinarian for your pet.

ELDU includes the use of any approved drug that is administered at: a dose, a route of administration (example: trans-dermal), a frequency of administration, or duration of administration for a disease, or to a species not listed on the drug label. This also includes the use of compounded drugs or drugs that do not have Canadian approval.

ELDU is an important tool for the humane care of sick animals since it gives your veterinarian access to drugs which may be registered for human use or which may have limited registration for veterinary use. There are conditions and situations where no licensed products exist for a particular species.

Compounding may be necessary and beneficial for the treatment of your pet. When the veterinarians at Golf Glen Veterinary Clinic prescribe a compounded or Extra-label drug, or we recommend an OTC medication, (antihistamine, insulin), we do so knowing that the medications are generally recognized by the Veterinary community as being safe and effective for the prescribed use. We use many resources to research the use of these drugs before we prescribe them. The compounded medications we order come from specialized compounding pharmacies.

We are required by the College of Veterinarians of Ontario to inform you about ELDU in your pet in order to obtain ‘Informed Consent’ from you for the drug use. We are also required to inform you that a potential for causing harm exists when drugs not approved by Health Canada are used (ELDU drugs and compounded medications have not had safety, potency, and efficacy approval). As with any treatment regime (including approved drugs), the potential exists for treatment failures and adverse reactions (including death), although adverse events are rare.

If you have any questions about ELDU, Compounded Prescriptions, or OTC medications please call Golf Glen Veterinary Clinic at 905-727-3003.

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