ARCHIVED - For Your Information: The Use of Unapproved Veterinary Drugs [Factsheet]

Questions

1. What is an unapproved drug?
2. What are the issues regarding the use of unapproved veterinary drugs?
3. What are the potential risks involved in eating food derived from animals treated with unapproved drugs?
4. What are some of the factors which may lead a veterinarian or animal owner to use unapproved drug products?
5. What is Health Canada doing about the use of unapproved veterinary drugs?
6. What are stakeholders doing about the use of unapproved veterinary drugs?
7. How can I keep up to date on this issue?
8. How can I be involved?

Answers

1. What is an unapproved drug?

An unapproved drug is defined as a drug that does not have a valid Drug Identification Number (DIN), and whose sale has not been authorized in Canada. The use of unapproved drugs in food-producing animals presents a complex set of issues with potentially serious public health implications.

2. What are the issues regarding the use of unapproved veterinary drugs?

When used according to the directions on the label, veterinary drugs approved for sale in Canada are safe and effective. When a medicinal product for human use is taken by an individual (with or without consultation with a health professional), it is based on an assessment that concludes that health benefits outweigh potential risks for that particular person - in this case, a voluntary decision. However, when food-producing animals are treated with unapproved drugs, residues may be present in food, and some level of risk may be unknowingly passed on to consumers - an involuntary choice. Any such residues may also be a violation of standards set under the Canadian Food and Drugs Act and Regulations which are enforced by the Canadian Food Inspection Agency (CFIA).

3. What are the potential risks involved in eating food derived from animals treated with unapproved drugs?

Residues in food from animals treated with unapproved drugs

A Maximum Residue Limit (MRL) is the safe amount of residue that could remain in the tissue or food product derived from a food-producing animal that has been treated with a veterinary drug. This residue is considered to pose no adverse health effects if ingested daily by humans over a lifetime. MRLs are established only after VDD has conducted extensive reviews of data submitted by manufacturers and has determined that foods containing these veterinary drugs residues up to the recommended levels, are safe for human consumption.

When unapproved drugs are used or when approved drugs are used in an extra-label manner, MRLs have usually not been established by Health Canada. Imported veterinary drugs not approved in Canada may or may not have an MRL from another country. However, there may be differences in the methodology used to measure residues or in the way that the MRLs are calculated because Canada's drug approval system, animal husbandry practices and legislation vary from that of other countries. Therefore, food from animals treated with unapproved drugs could contain potentially harmful and violative levels of residues, which could result in short or long-term health effects for those eating that food.

Development of antimicrobial resistance as a result of the use of unapproved veterinary drugs

Over-use and/or inappropriate use of antimicrobial drugs can lead to increased antimicrobial resistance (AMR). AMR occurs when a specific antimicrobial drug is ineffective in killing or slowing down the growth of a targeted microorganism. Development of resistance stops or reduces the effectiveness of antimicrobials intended to treat certain human/animal infections. The emergence of AMR threatens our ability to fight human and animal diseases with potentially serious public health implications. Effective antibiotics could become fewer in number. This could narrow the line of defense against bacterial infections to only a few antibiotics and may increase health care costs.

4. What are some of the factors which may lead a veterinarian or animal owner to use unapproved drug products?

• No approved product is available in Canada to treat a specific condition or illness.
• An imported, unapproved product is cheaper than an approved Canadian product.
• Lack of understanding as to the difference between approved and unapproved products or a misunderstanding of policies and regulations related to these products.
• A drug may be on "back-order" and, therefore, unavailable from the pharmaceutical industry when needed.
• The unapproved product may be imported with an animal (e.g., a show dog or a race horse) that has been travelling outside the country and is returning to Canada.

5. What is Health Canada doing about the use of unapproved veterinary drugs?

Public health issues arise as a result of the use of unapproved drugs. VDD has identified four facets of this issue: the use of approved drugs outside of approved conditions of use (extra-label drug use or ELDU), importation of unapproved drugs for animals, compounding, and active pharmaceutical ingredients (APIs).

• Extra-label drug use (ELDU)
  When VDD approves veterinary drugs for sale in Canada, conditions of use (the purpose of the drug, animal species, dosage, duration of therapy, etc.) are described on the product labels, including the package insert or product monograph. The treatment of animals outside of these approved directions is referred to as "extra-label" or "off-label" use. With any decision to use a drug in an extra-label manner, there may be associated risks to animal and human health.
  
  In 2003, VDD undertook a study to gather information regarding the nature and scope as well as the impacts of drug use in animals in Canada. Its purpose was to highlight areas for further consultation, and allow VDD to identify gaps in the accessibility of veterinary drugs. Due to unforseen complexities, such as uncertainty about quality of output and continued funding, the field work was suspended.
  
  VDD is continuing to work with our stakeholders and federal, provincial and territorial partners to develop new approaches to addressing this issue. In the meantime, data from the pilot surveys have helped guide VDD on future work.
  
• Importation of unapproved drugs for animals
  Current legislation prohibits the importation of unapproved drugs for sale in Canada, but does not prohibit veterinarians or producers from importing unapproved veterinary drugs for "personal use" that is, to treat their own animals. This may pose a problem if these unapproved drugs are administered to their personal livestock destined for the food chain. Health Canada takes this issue seriously and has obtained legal advice regarding an amendment to the Food and Drugs Regulations to restrict personal use importation of drugs intended to be administered to food-producing animals. Mechanisms that are currently in place to allow the importation of unapproved drugs for medical or research purposes would still apply, such as Emergency Drug Releases (EDRs) and Experimental Studies Certificates (ESCs).
  
• Active Pharmaceutical Ingredients (APIs)
  APIs are a substance or a mixture of substances intended to be used in the manufacture of a drug which become "active ingredients" of the drug product. APIs are not approved to be used directly as drugs. Health Canada's Health Products and Food Branch has been made aware of cases related to the sale of bulk active pharmaceutical ingredients (APIs) to farmers, pharmacists, feed mill operators, retailers and veterinarians for direct administration to animals. This poses a significant public health issue, given the potential risks to the public from exposure to drug residues in food derived from treated animals.
  
  A policy published in 1999 specifies that the sale of APIs for direct administration to animals makes those administering drugs to animals subject to the licensing, quality, safety and efficacy requirements applicable to veterinary drugs in the Food and Drugs Act and Regulations.
  
  Health Canada is also working toward better control of the quality and traceability of APIs used in the manufacture of human and veterinary drugs. Health Canada has in place a Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients, which is based on international standards. This document provides detailed guidance regarding good manufacturing practices (GMP) for the manufacturing of APIs under a system for managing quality. It also helps to ensure that APIs meet the requirements for quality and purity. On July 1, 2003, the Health Products and Food Branch Inspectorate published a drug annex for GMP related to veterinary drugs in order to have in place uniform and effective controls to minimize the health risks and the negative impact on commerce associated with APIs sold in bulk for veterinary use.
  
• Compounding
  The practice of veterinary medicine sometimes requires access to drugs in a dosage form or concentration not available on the Canadian market. Compounding, a form of extra-label use, is the mixing of drugs in finished or unfinished form by a pharmacist or veterinarian for individualized drug therapies. Certain types of compounding (e.g., from bulk APIs for administering to food-producing animals) may present a risk to animal and public health.
  
  Only licensed professionals (veterinarians and pharmacists) are permitted to compound medication for use in animals, and this must be done according to professional standards of practice. The Canadian Veterinary Medical Association, Health Canada and other partners in animal health and public health are developing national guidelines for the legitimate compounding of drugs for animals.

6. What are stakeholders doing about the use of unapproved veterinary drugs?

The use of unapproved drugs involves many jurisdictions and interested parties.

• Health Canada is the federal lead with the mandate to maintain and improve public health and authorize the sale of safe and effective therapeutics in Canada. Health Canada is also responsible for setting maximum residue limits (MRLs) for veterinary drug residues on food.
• The Canadian Food Inspection Agency undertakes monitoring and compliance activities to make sure that MRLs are adhered and to take corrective action if warranted.
• Provincial governments have the mandate to facilitate animal and human health through professional standards for the practice of veterinary medicine and pharmacy.
• Veterinarians have the responsibility to act in the best interest of their patients' health and welfare and to ensure that the drugs they prescribe for food-producing animals will not result in harmful or violative residues.
• Drug manufacturers are responsible for ensuring that the drugs they manufacture are safe and effective and meet the standards set by regulations.
• Farmers and producers must respect the regulations in order to maintain the safety of food produced from animals and are also responsible for the humane treatment of animals under their care.

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

You can obtain up-to-date information on unapproved drugs and other veterinary drug health issues by visiting the "What's New" page on our Web site:
www.hc-sc.gc.ca/dhp-mps/vet/index-eng.php

8. How can I be involved?

Health Canada is working to make public participation part of decision making related to public health issues such as the use of unapproved drugs. We invite you to send us your comments.

Health Canada contact information:

Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
Holland Cross Complex, Ground Floor
14 - 11 Holland AvenueOttawa, Ontario. K1A 0K9
Address Locator - 3000A

General Information Number:

(613) 954-5687
Fax : (613) 957-3861
E-mail: vetdrugs-medsvet@hc-sc.gc.ca