Health Canada’s policy on extra-label drug use in food-producing animals in Canada

Health Canada recognizes that extra-label drug use (ELDU) in animals is a tool in the practice of veterinary medicine. Drugs are used in an extra-label manner for a variety of reasons and certain instances of ELDU practice may be warranted for the humane care of animals. However, Health Canada is concerned with uncontrolled practice of ELDU in food-producing animals due to potential public health risks. The Veterinary Drugs Directorate (VDD) of Health Canada is responsible for evaluating and monitoring the safety, quality, and effectiveness of veterinary drugs in addition to setting standards and promoting the prudent use of drugs administered to food-producing and companion animals. Consistent with Health Canada’s mandate, a policy development process was initiated in collaboration with stakeholders and the ELDU Advisory Committee in order to explore options to minimize the animal and public health risks associated with the practice of ELDU. The proposed ELDU standards are consistent with international perspectives (1).

This policy is applicable to ELDU in food-producing animals in Canada. Health Canada’s goal is that this policy will establish a national uniform standard for ELDU practice in Canada. The net effect of this policy is to create awareness of the need to ensure that drugs are used prudently in food-producing animals. Consequently, the Canadian food products derived from animals will maintain their competitiveness in international trade (2).

What is ELDU in Canada?

ELDU, often referred to as “off-label use,” is the use of any drug, whether it is a prescription drug or over-the-counter drug, in an animal in a manner that is not in accordance with the approved label or the package insert of the drug licensed by Health Canada (3).

ELDU is practised when drugs are used in a different manner from what is indicated on the label, such as at a different dosage, greater or lesser frequency, different indication, longer or shorter duration, or different routes of administration. This includes cases where drugs are used in different animal species, different age groups, different state of the animal’s production cycle, different dosage form (for instance, a tablet may be crushed into powder and incorporated into a gel), or in combination with other drugs in a manner other than that indicated on the label or package insert. ELDU may also include the use of drugs approved in humans to treat animal species or the use of drugs in a medicated feed outside of the Medicated Ingredient Brochure (MIB) listing. Compounding, which is defined as the reformulation of an active pharmaceutical compound to address the unique physiological needs of an individual animal, as determined under a valid veterinarian/client/patient/relationship (VCPR), which cannot be met by current, commercially available product formulations, is considered a form of ELDU (4). In general, the use of unapproved drugs in animals or of unapproved Active Pharmaceutical Ingredients (APIs), which are administered as is or formulated by compounding, is a common form of ELDU.

Who performs ELDU practice in Canada?

While the prevalence of ELDU practice in Canada is not known, it is not limited to veterinarians. ELDU is being performed by other health care professionals (including pharmacists, registered veterinary technicians) and nonhealth care professionals such as producers, animal owners, trainers, and breeders. The practice of ELDU by persons other than licensed veterinarians and not within a valid VCPR poses potential human and animal health risks.

The levels of risks to public health or animal health will vary depending on the degree of this practice. It is for this reason that in certain jurisdictions such as the United States, European Union, Australia, and New Zealand, ELDU practice is restricted to veterinarians (3). Essentially, veterinarians are best positioned to adequately evaluate the health risks associated with ELDU and to assume responsibility for this activity.

Federal and provincial jurisdiction over the regulation of ELDU

In Canada, the use of drugs involves aspects within provincial and federal regulatory responsibility. Generally, the aspect of the use of drugs in animals falling under the rubric of the practice of veterinary medicine is one that is regulated in the provincial sphere. Currently, the federal regulatory framework does not set out requirements specific to the practice of ELDU. However, to the extent that there is federal legislative authority to regulate the approval, sale, and labelling of drugs, Health Canada can take into account a drug’s extra-label use in determining whether its labelling is sufficient to satisfy safety and efficacy requirements. If a risk is identified with respect to extra-label use, Health Canada may require that a product be labelled with an express warning or contraindication against such use.

In light of the jurisdictional limitations of Health Canada’s role in the practice of ELDU, there is a need for the federal, provincial, and territorial governments to continue to work together to ensure maximum public health protection. Health Canada appreciates the efforts and partnerships of provincial counterparts and professional veterinary associations in promoting prudent use of drugs in animals.

This policy is intended to create a national, harmonized standard for ELDU practice in order to minimize public health risks. As with other major trading partners, Health Canada recognizes that ELDU should only be practised by licensed veterinarians. Potential public health risk is primarily associated with the practice of ELDU by individuals other than veterinarians who are not regulated by the various provincial acts and bylaws that govern veterinary medicine.

What are the potential human health risks of concern?

It is recognized that drugs are used in an extra-label manner for a variety of reasons. As a result, certain instances of ELDU practice may be warranted for the humane care of animals. However, there are human safety concerns relating to the development of antimicrobial resistance (AMR) and the presence of potentially harmful drug residues in foods derived from treated animals, which should be considered prior to making decisions on ELDU. Given the multi-dimensional nature of ELDU practice, veterinarians are best positioned to critically evaluate the risks and assume responsibility for this practice (3).

Scope of the ELDU policy

The ELDU policy applies to the extra-label use of approved drugs as well as unapproved APIs and compounded drugs in all animals intended for food. It is intended to guide all users of pharmaceutical products who might want to use the drugs in food-producing animals in an ELDU manner (5). For a complete copy of the ELDU policy on Extra-Label Drug Use in Food Producing Animals visit Health Canada’s Web site (5).

Key elements of Health Canada’s policy on ELDU

Health Canada takes the following view:

1. ELDU is a recognized tool in the “practice of veterinary medicine” for animals within a “valid” Veterinarian-Client-Patient Relationship (VCPR), since it facilitates access by veterinary practitioners to certain drugs for the treatment of animals.

2. ELDU in food-producing animals by persons other than licensed veterinarians is not recommended except when such use is conducted under the supervision of a veterinarian within the context of a valid VCPR.

3. ELDU is not recommended with drugs of very high importance to human health which are listed as Category I Antimicrobials (6).

4. ELDU should only be undertaken in compliance with the Food and Drugs Act and Regulations that specify the requirements with respect to banned substances (C.01.610.1), medicated feeds (C.08.012), and violative residues.

What is a “valid VCPR?”

Health Canada considers a “valid VCPR” to exist when the following conditions apply (4):

1. the client [owner or owner’s agent of the animal(s)] has given the responsibility of medical care to the veterinarian and has agreed to follow the instructions of the veterinarian; and

2. the veterinarian has assumed the responsibility from the client for making clinical judgment regarding the health of the animal(s), the need for medical treatment, and for ensuring the provision of ongoing medical care for the animal(s); and

3. the veterinarian has sufficient knowledge of the health status of the animal(s) and the care received or to be received. The knowledge has been obtained through a recent examination of the animal(s) and the premises where it is (they are) kept or through a history of medically appropriate and timely examinations and interventions; and

4. the veterinarian is readily available, or has made the necessary arrangements with another veterinarian, for ongoing medical care in case of adverse reactions or therapy failure.

Health Canada’s intent is to promote prudent and judicious use of drugs, especially the available antimicrobial drugs, in food-producing animals in order to minimize the risks to public health, animal safety, and the environment. A concerted effort is required by all partners so that drugs are used appropriately in order to ensure the safety of Canada’s food supply.

Health Canada’s policy development on ELDU incorporated consultation with stakeholders, including the Advisory Committee on ELDU.