Health Canada's Veterinary Drugs Directorate's (VDD's) Study To Assess Drug Use in Animals in Canada
Questions
- What is extra-label drug use?
- What was the objective of the drug
use in animals in Canada study?
- Why was the study temporarily suspended?
- Is ELDU Illegal?
- Will stakeholders continue to be involved
in decision-making regarding this issue?
- What is the decision-making process?
- What is Health Canada doing to improve
the efficiency of our veterinary drug approval process?
Answers
1. What is extra-label drug use?
Extra-label drug use (ELDU) is defined as the use of a drug product in
a manner that is not consistent with what is indicated on the label, package
insert or product monograph of any drug product approved by Health Canada.
2. What was the objective of the drug
use in animals in Canada study?
The objective of this study was to gather up-to-date and comprehensive
information and understanding of the nature and scope as well as the impacts
of drug use in animals in Canada, to highlight areas for further consultation,
and allow us to identify gaps in the accessibility of veterinary drugs.
This study was initiated in part as a component of Canada's action plan
in response to the European Union (EU) audit of the safety of Canadian
food in 2000. The audit and Canada's action plan are part of ongoing efforts
to continuously improve the food safety system.
3. Why was the study temporarily suspended?
This was the first time in Canada that such a study had been undertaken.
Unforseen complexities arose relating to logistics, the quality of output
and funding, which caused us to review our decision to proceed with the
field work at this time. As the first study of its kind in Canada, it
is important that it be done correctly in order for the data to be used
now and as a foundation for future work.
4. Is ELDU Illegal?
No. Under the advice of a veterinarian, ELDU by producers would not constitute
a violation of Canada's Food and Drugs Act and Regulations.
However, when ELDU is employed in the treatment of food-producing animals,
it must not lead to residues in food that would constitute a violation.
In some provinces, the advice of a veterinarian is a legal requirement
when a producer uses a product in an extra-label manner.
5. Will stakeholders continue to be involved
in decision-making regarding this issue?
Yes. Health Canada is aware of the importance of access to effective
and affordable drugs to producers and will continue to work with a committee
of stakeholders on key issues such as ELDU, to ensure transparency and
that stakeholders views are taken into consideration in the development
of next steps.
6. What is the decision-making process?
In accordance with Health Canada's Decision Making Framework (DMF), risk/benefit
assessments and policy development are evidence-based. The DMF is also
based on working with stakeholders. This is essential to our ability to
address and move forward with this policy issue within the overall policy
direction.
7. What is Health Canada doing to improve
the efficiency of our veterinary drug approval process?
Since its establishment in 2001, the Veterinary Drugs Directorate (VDD)
has built a stable organization, increased its capacity and expertise,
and has developed new policies and guidelines. This has resulted in a
significant decrease in the backlog of veterinary drug submissions and
improved the veterinary drug approval process.
Health Canada continues to work diligently to decrease the need for extra-label
drug use through measures such as reducing our backlog of drug submissions
awaiting review, and developing new policies and guidelines in consultation
with our stakeholders.
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