Adverse Drug Reactions (Pharmacovigilance)
Once new veterinary drugs are authorized for sale in Canada, it is important to monitor these drugs and their effects while they are in more widespread use. To meet this need, Health Canada's Veterinary Drugs Directorate (VDD) formalized its pharmacovigilance program.
Pharmacovigilance or post-market surveillance includes the collection and analysis of suspected Adverse Drug Reactions (ADRs). An ADR is an unintended reaction to a drug resulting in mild to severe adverse symptoms. The purpose of this activity is to monitor:
- the safety and efficacy of veterinary drugs used in animals; and
- the safety of humans handling these products and consuming food derived from treated animals.
Canada's Food and Drugs Act and Regulations require manufacturers to report all suspected adverse drug reactions to Health Canada.
Veterinarians and technicians are the first point of contact for adverse drug reaction reporting in clinical practice. Although there are no regulations requiring veterinary practitioners to report ADRs, VDD encourages veterinarians to report suspected adverse reactions to any drugs which occur in their practices to the manufacturer or to VDD. A fact sheet For Your Information: Adverse Drug Reactions (Pharmacovigilance) and Questions and Answers - ProHeart®6 Injectable Heartworm Product for Dogs provide additional details. For information on national and international efforts to address this issue please refer to these links.
Advisories, Warnings & Recalls
Links:
Canada - Government Organizations and Information
Veterinary Drugs Directorate - Antimicrobial Resistance
Marketed Health Products Directorate (MHPD)
Adverse Reaction Information
Health Products and Food Branch (HPFB) Inspectorate: Acts and Regulations
Health Products and Food Branch Drug Products Database
 Canadian Food Inspection Agency (CFIA), Animal Health and Production Division: Veterinary Biologics Section
Guidelines for Reporting Suspected Adverse Reactions to Veterinary Biologics
Form for Notification of Suspected Adverse Reactions to Veterinary Biologics (CFIA-2205) (PDF Version)
Pest Management Regulatory Agency (PMRA)
Cosmetics programme, Healthy Environments and Consumer Safety Branch
Canada - Other Organizations
Canadian Veterinary Medical Association (CVMA)
International - Government Organizations
US Food and Drug Administration (FDA), Centre for Veterinary Medicine (CVM)'s Adverse Drug Experience Reporting
VICH (International Conference on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products)
Australian Pesticides and Veterinary Medicines Authority (APVMA), Adverse Experience Reporting Programme for Veterinary Chemical Products
European Agency for the Evaluation of Medicinal Products (EMEA), Veterinary Medicines and Inspections
Veterinary Medicine Directorate (United Kingdom); Suspected Adverse Reaction Reporting Scheme (SARRS)
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