For Your Information: Pharmacovigilance
Questions
- What is Pharmacovigilance?
- What is the Issue?
- What is the role of the veterinarian?
- What is the role of manufacturers?
- Which adverse drug reactions should
be reported?
- What is the role of VDD?
Working with Stakeholders
- 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
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