Issue Identification Paper - Extra Label Drug Use

December 2, 2004

Issue Identification Paper - Extra Label Drug Use

Dear Stakeholders:

The Extra Label Drug Use (ELDU) of drugs in animals is an extremely important public health issue.

The use of human drugs is the result of a decision made between a patient and a doctor. The risk/benefit impacts the patient. However, the decision to use any drug on a food- producing animal has implications for the food chain and thus on the health of Canadian consumers. When a veterinary drug is approved for sale in Canada for use in a particular food-animal species, dosages and withdrawal periods are indicated on the label. In addition, Maximum Residue Limits (MRLs), which are associated with withdrawal periods (WPs) (i.e., stopping the administration of a drug before slaughter) are established for these approved drugs. In the case of ELDU in food-animals , the implications are even more complex, since MRLs and WPs may no longer be applicable, and in some cases this practice could cause an undue risk to consumers.

In October 2002, Health Canada's Veterinary Drugs Directorate (VDD) established a Steering Committee consisting of sixteen members to provide expert advice and guidance on various aspects of a Drug Use in Animals Study. 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 that time.

The Steering Committee agreed to continue its work under a different mandate to find alternative means of gathering needed information on ELDU in animals in Canada. It thus became the VDD ELDU Advisory Committee. Over the past year, Health Canada staff and the VDD ELDU Advisory Committee have worked to develop an Issue Identification Paper that identifies and groups the complex range of issues related to ELDU in animals. The purpose of this paper is to achieve a common understanding of ELDU in animals and to enable us to proceed with the risk assessment and development of risk management strategies and policies.

Your collaboration in bringing this information to the attention of all interested parties in your organization would be greatly appreciated.

Any questions should be referred to:

Ms. Dhurata Ikonomi
Public Involvement Officer
Strategic Planning and Stakeholder Relations, Veterinary Drugs Directorate
Health Products and Food Branch, Health Canada
Holland Cross Complex, 14 - 11 Holland Avenue
Ottawa, ON K1A 0K9
By fax: (613) 954-9860 or E-mail: Dhurata_Ikonomi@hc-sc.gc.ca

We look forward to receiving your comments.

Sincerely,

Diane C. Kirkpatrick,
Director General