For Your Information: Pharmacovigilance

Questions

1. What is Pharmacovigilance?
2. What is the Issue?
3. What is the role of the veterinarian?
4. What is the role of manufacturers?
5. Which adverse drug reactions should be reported?
6. What is the role of VDD?

Working with Stakeholders

1. How can I keep up-to-date on this issue?

VDD's Pharmacovigilance program contact information

Answers

1. What is Pharmacovigilance?

For the Veterinary Drugs Directorate (VDD), Pharmacovigilance means Adverse Drug Reaction (ADR) reporting or post-market surveillance to monitor the safety and efficacy of veterinary drugs.

An adverse drug reaction is an unintended reaction to a drug at doses that are considered normal.

Canada's Food and Drugs Act and Regulations require manufacturers to report suspected adverse reactions to a veterinary drug to Health Canada's Veterinary Drugs Directorate. Veterinarians are encouraged to also report these incidences to VDD, but are under no legal obligation to do so.

2. What is the Issue?

VDD approves veterinary drugs when pre-marketing data (preclinical and clinical) satisfy scientific and regulatory requirements for efficacy and safety in the intended species. It must also be demonstrated that food products derived from treated animals will be safe for human consumption. ADRs may not be identified before a veterinary drug is approved for sale since limited numbers of animals are tested in controlled clinical trials. As new drugs come onto the market, it is important to continue to have a post-market surveillance program in place.

3. What is the role of the veterinarian?

Veterinarians and technicians are the first point of contact for adverse drug reaction reporting in clinical practice. You can contribute by reporting any suspected adverse drug reactions directly to the manufacturer or to VDD. This will allow the most accurate and up-to-date information on the safety and effectiveness of a veterinary drug.

4. What is the role of manufacturers?

The Food and Drugs Act and Regulations require veterinary drug manufacturers to report the following types of adverse drug reactions to the VDD within 15 days of receiving the information:

• all suspected adverse reactions to veterinary drugs occurring in Canada; and
• all information relating to any serious and unexpected adverse drug reactions occurring outside of Canada.

Manufacturers are also responsible for preparing an annual report on all adverse drug reactions, including a concise and critical analysis.

5. Which adverse drug reactions should be reported?

• all suspected adverse drug reactions which are unexpected and not consistent with product information or labelling;
• all suspected adverse drug reactions which cause significant disability or illness in a patient, require hospitalization or significant medical intervention, and which occur more frequently or more severely than expected from product information or labelling;
• any lack of efficacy when a veterinary drug is used according to product labelling (species, dose, indications, route of administration). This is particularly important for antimicrobials used in food-producing animals since this may give an indication of increasing antimicrobial resistance in animal pathogens; and
• any adverse reactions in humans resulting from the handling of or accidental contact with a veterinary drug.

6. What is the role of VDD?

When a suspected adverse drug reaction is received by VDD directly from a veterinarian, the manufacturer of the product is contacted and asked to investigate the incident. The manufacturer prepares and provides a written report to the attending/reporting veterinarian and to VDD. Adverse drug reactions reported to the manufacturer are automatically reported to VDD.

VDD's Pharmacovigilance Unit maintains a record of each suspected adverse drug reaction report in a database. The information is reviewed and classified according to whether the reaction is associated with the drug. This process is conducted in accordance with the international guidelines for pharmacovigilance activities developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

Based on the number of reports, their similarity and the degree of reaction, the next possible steps taken include:

• labelling changes such as new warnings, contraindications or human safety information;
• product recall of a particular lot of drug;
• in rare cases a drug may be removed from the market; or
• no action at this time.

Individual information on veterinarians, clinics, and owners/pets is kept confidential. Adverse drug reactions are assessed in light of compiled Canadian reports as well as comparing new information to pre-market data, literature, foreign data, reports from other agencies and epidemiological evidence. The aim of each assessment is to protect both human and animal health.

Working with Stakeholders

A core objective of VDD's Pharmacovigilance program is to work closely with veterinarians, pharmaceutical companies, federal and provincial governments and special interest groups. Cultivating strong partnerships and working in cooperation with key stakeholders is essential to the success of the program.

1. How can I keep up-to-date on this issue?

Visit VDD's Web site at: www.hc-sc.gc.ca/vetdrugs-medsvet; where Notices of Compliance (NOCs) and updated labelling information for individual veterinary products are available. Adverse drug reaction information will also be made available by VDD for publication in provincial veterinary association newsletters and the Canadian Veterinary Journal. Periodic adverse drug reaction reports may be sent to veterinary associations, manufacturers and special interest groups. VDD will also communicate regulatory actions to the publishers or authors of drug compendiums and handbooks.

Health Canada is working to make public participation part of policy development related to public health issues such as AMR. If you would like to comment or participate, please comment via our E-mail: vetdrugs-medsvet@hc-sc.gc.ca

VDD's Pharmacovigilance program contact information

Veterinary Drugs Directorate
Health Products and Food Branch

Health Canada
Holland Cross Complex
Ground Floor
14 - 11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator - 3000A

Suspected adverse drug reactions can be reported by fax or by completing an adverse drug reaction report form available on our Web site.

Fax: (613) 946-1125
Veterinarians and the public can reach us toll free at: 1-877-VET-REAC (1-877-838-7322)
Email: pharmacovigilance-vet@hc-sc.gc.ca