Drug Adverse Reaction Reporting

What is a Drug Adverse Reaction (DAR)?

The Veterinary Drugs Directorate classifies an adverse reaction to a veterinary drug as:

• any unintended or noxious side effects, injury toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting a drug;
• any unusual failure of a drug to produce its expected pharmacological activity.

Who should report?

The Food and Drugs Act and Regulations require that manufacturers report suspected adverse reactions to new drugs (for regulatory purposes, drugs approved for marketing since 1963, and drugs not yet approved) to the VDD in the Health Products and Food Branch within 15 working days of receipt of such information.

Though there are no regulations requiring veterinary practitioners to report DARs, the Veterinary Drugs Directorate encourages veterinarians to advise us of suspected adverse reactions to any drugs which occur in their practices.

Why report suspected DARs?

Premarketing clinical trials of a new drug generate data to satisfy the requirements of the Food and Drugs Act and Regulations for animal safety and efficacy, and human safety. The purpose of post marketing surveillance, including DAR reporting, is to continue to monitor the drugs and its effects while in more widespread clinical use.

The more practitioners who report suspected adverse reactions to veterinary drugs, the larger our data base and the more valid our evaluation and appropriate our response.

Reports received by the VDD are discussed, verbally or in writing, with the practitioner and the manufacturer. A summary of reported suspected reactions is published in the Canadian Veterinary Journal. Confidentiality is respected by excluding specific reference to the name of the veterinary practitioner/practice, client, manufacturer and brand name of the drug.

Which DARs should be reported?

• all suspected drug adverse reactions which are unexpected: an undesirable patient effect which is not consistent with product information or labelling
  
  
• all suspected drug adverse reactions which are serious: an undesirable patient effect which contributes to significant disability or illness, which requires hospitalization or significant medical intervention, or which is more severe or more frequent than expected from product information or labelling
  
  
• all suspected drug adverse reactions to recently marketed drugs (commercially available for less than 7 years), regardless of nature or severity
• lack of efficacy when the drug was used according to product labelling (species, dose, indications, route of administration)

How to report a suspected DAR?

Please report as soon as possible after the occurrence.

Report by telephone, fax or by completing a DAR Report Form (PDF).

Provide as much history and detail as possible, including laboratory and necropsy results.

Report to:

Adverse Reaction Officer:
Tel: 1-877-838-7322
Fax: (613) 946-1125
General Tel: (613) 954-5687
Submission and Knowledge Management Division, VDD
Fax: (613) 946-1125

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Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
Holland Cross Complex
Tower A, Ground Floor
11 Holland Avenue
Ottawa, Ontario K1A 0L2
Address Locator - 30000A

Please note: The Veterinary Drugs Directorate deals only with suspected adverse reactions to veterinary drugs.

Suspected adverse reactions to veterinary biologics (vaccines, bacterins, etc.) should be reported to:

Canadian Food Inspection Agency
Animal Products Directorate
Animal Health and Production Division
Veterinary Biologics Section
59 Camelot Drive
Ottawa, ON K1A 0Y9

Suspected adverse reactions to veterinary pesticides (eg. Topical treatments for external parasites) should be reported to:

Director
Pest Management Regulatory Agency
2250 Riverside Drive
A.L. 6606D2
Ottawa, ON K1A 0K9
Tel: 1-800-267-6315
Outside Canada (Long distance charges apply): 1-613-736-3799

Revised December 14, 2001