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Veterinary Biologics Guideline 3.15E

Guidelines for Reporting Suspected Adverse Events to Veterinary Biologics

INTRODUCTION

The following is a summary of the responsibilities of veterinary practitioners and veterinary biologics companies for reporting and investigating suspected adverse events.

The Canadian Food Inspection Agency (CFIA) is responsible for licensing animal vaccines and diagnostic kits for infectious diseases in Canada. The licensing program operates under the Health of Animals Act and Regulations, and is administered by the Veterinary Biologics Section.

To meet federal licensing requirements, each veterinary biologic must be shown to be pure, potent, safe, and efficacious when used according to the label recommendations. Following licensing, the Regulations require all holders of product licences and import permits (manufacturers, commercial importers, veterinarians, or diagnostic laboratories) to report all suspected adverse events to CFIA within 15 days of receiving notice from an owner or veterinarian. This includes complaints regarding veterinary biologics manufactured or imported for commercial, research or emergency use in Canada or those manufactured "For Export Only". For reporting purposes, suspected adverse events are defined as those which have a serious impact on the health, productivity, or marketability of an animal. These are described in the following pages. While holders of import permits are not required to report each separate adverse event which has occurred in another country, they are required to report any information or adverse event which may indicate a significant deficiency in the safety, potency, or efficacy of a product being distributed in Canada.

Veterinarians who encounter suspected adverse events should notify CFIA, either directly or through the vaccine manufacturer or distributor. A form for reporting adverse events is available from CFIA district offices and the Veterinary Biologics Section. A copy may also be obtained from the CFIA website. This form is also included in the Compendium of Veterinary Products, which is published in consultation with the Canadian Animal Health Institute. A copy of the Notification of Suspected Adverse Events to Veterinary Biologics form is attached.

When the Veterinary Biologics Section receives an adverse event complaint, the manufacturer is contacted and asked to investigate the problem and prepare a report for the owner's veterinarian and CFIA. Depending on the nature of the complaint, the manufacturer may be required to submit samples of the product to CFIA's laboratories for testing, or conduct additional safety studies. If the adverse event rate is excessive for a particular serial or vaccine, the manufacturer may be ordered to temporarily stop sale of an affected serial, or withdraw the vaccine from the market. When a product must be withdrawn from the market or a specific serial must be recalled, the manufacturer provides written notice to veterinarians and other purchasers. This notification is usually done through a letter, which must be approved by the Veterinary Biologics Section.

The individual adverse event reports which are submitted to the Veterinary Biologics Section are considered confidential information, which is subject to the Access to Information Act and the Privacy Act. Before releasing this information to the public, CFIA must obtain written permission from the individuals or corporations involved.

ADVERSE EVENT TO BE REPORTED

Under the Health of Animals Regulations, Section 135.1 states that "Every holder of a license or permit issued under this Part shall report to the Minister in writing, any information concerning or any evidence of a significant deficiency in safety, potency, or efficacy of a veterinary biologic within 15 days from the date on which such information or evidence is known to him or is generally known to the industry, whichever is earlier."

The following categories of suspected adverse events should be reported to the Veterinary Biologics Section:

Type 1 events are defined as any systemic adverse reaction, anaphylactic or hypersensitivity, requiring veterinary treatment including: persistent fever (lasting more than 48 hours), recumbency, persisting lethargy, decrease in activity, muscle tremors, shivering, hyper-salivation, dyspnea and other respiratory problems, cyanosis, diarrhea, vomiting, colic and other gastrointestinal problems, eye problems, significant persistent drop in production, abortions and other reproductive problems, neurological signs.

Type 2 events are defined as death or an increase in mortality rate following vaccination.

Type 3 events are defined as local persistent events (such as edema, abscess, granuloma, fibrosis, alopecia, hyper-pigmentation) and/or excessive pain at injection site reported by a veterinarian or owner.

Type 4 events are defined as a lack of efficacy.

Manufacturers are required to maintain records of all suspected adverse events. All cases involving Type 1, 2, 3, and 4 events must be investigated and reported to the Veterinary Biologics Section. Isolated cases of mild, transient local injection site events that resolve without treatment must be investigated by the manufacturer, but need not be reported to the Veterinary Biologic Section.

The Veterinary Biologics Section reviews each suspected adverse event and classifies it according to the likelihood of its association with the administered vaccine(s). The categories being used for classification are in accordance with international guidelines for pharmacovigilance activities ( VICH International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products: pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports):

Probable: For inclusion in this category, the following criteria should be met: a) there should be a reasonable association in time between the administration of the vaccine and the suspected adverse event, b) the clinical signs or pathological lesions should be plausible given the vaccine ingredients and expected adverse events, and c) there should be no equally plausible cause for the suspected adverse event.

Possible: For inclusion in this category, the administration of the vaccine is one of the possible and equally plausible explanations for the suspected adverse event. This category may be used when several products or antigens are given to an animal simultaneously, and it is not known which product caused the adverse event.

Unlikely: For inclusion in this category, sufficient information must exist to establish that the described adverse event was not likely to be associated with the administration of the vaccine(s), or another more plausible explanation exists.

Unknown: For inclusion in this category, reliable data is either unavailable or is insufficient to make an assessment.

No Assessment: For inclusion in this category, no assessment was done.

APPENDIX

The form Notification of Suspected Adverse Events to Veterinary Biologics is an attachment and constitutes part of this document.

Address for Notification of Suspected Adverse Events:

Veterinary Biologics Section
Canadian Food Inspection Agency
2 Constellation Crescent (Floor 8),
Ottawa, Ontario K1A 0Y9
Tel: 613-221-7566
Fax: 613-228-6612