Guide to the Professional Practice Standard
Published: August 2018
Introduction
Extra-label drug use refers to the use of a drug that is not in accordance with the approved label or the package insert of the drug licensed by Health Canada. Extra-label drug use encompasses a broad range of activities. Extra-label drug use can be a significant component of a veterinarian’s practice, and can be essential for certain animal species.
As a drug used in an extra-label manner has not undergone the drug review process at Health Canada that ensures that a drug product has received rigorous scientific scrutiny and satisfies all requirements and criteria that are prescribed by the Food and Drug Regulations, a drug used in an extra-label manner does not have proven safety or efficacy characteristics based on its intended use. According to Health Canada, extra-label drug use presents a number of potential public health and food safety risks, including violative drug residues being present in food products derived from ELDU-treated animals, the emergence and/or aggravation of antimicrobial resistance, and potential adverse reactions to an animal or group of animals since these products may not have been tested appropriately for the intended condition.
Using a question-and-answer format, this Guide to the Professional Practice Standard: Extra-Label Drug Use addresses questions and offers suggestions on how to apply the Professional Practice Standard in situations that arise in veterinary practice.
Frequently Asked Questions about General Expectations
When determining which drug to prescribe, a veterinarian uses their clinical judgment to recommend the most appropriate course of treatment for an animal or animals, taking into consideration the following:
- The availability of any approved veterinary drugs for the species in question and condition (on-label use)
- The availability of veterinary drugs or approved human drugs (extra-label use)
- The need for a compounded drug where no approved drug exists, and a therapeutic need is established
- Current research and evidence of available treatments
- Considerations such as side effects, risks, and benefits
Yes. A veterinarian undertaking ELDU is required to obtain informed consent within an existing veterinarian-client-patient relationship.
A veterinarian is permitted to use their professional discretion when determining the threshold for informed consent. Oral consent may be acceptable in cases of lower risk. However, it is recommended that written consent be sought in cases of higher risk.
Legislative Authority
Food and Drugs Act and Regulations (Federal)
Feeds Act and Regulations (Federal)
Controlled Drugs and Substances Act and Regulations (Federal)
Drug and Pharmacies Regulation Act and Regulations (Provincial)
Drug Interchangeability and Dispensing Fee Act (Provincial)
Veterinarians Act (Provincial)
Regulation 1093, s. 1, 18, 23-33 (Veterinarians Act) (Provincial)
Resources
The following can be found at the College’s website at cvo.org:
Professional Practice Standard: Prescribing a Drug
Guide to the Professional Practice Standard: Prescribing a Drug
Professional Practice Standard: Dispensing a Drug
Guide to the Professional Practice Standard: Dispensing a Drug
Professional Practice Standard: Extra-Label Drug Use
Professional Practice Standard: Use of Compounded Drugs in Veterinary Practice
Guide to the Professional Practice Standard: Use of Compounded Drugs in Veterinary Practice
Professional Practice Standard: Management and Disposal of Controlled Drugs
Guide to the Professional Practice Standard: Management and Disposal of Controlled Drugs
Professional Practice Standard: Informed Client Consent
Guide to the Professional Practice Standard: Informed Client Consent
Professional Practice Standard: Medical Records
Guide to the Professional Practice Standard: Medical Records
Professional Practice Standard: Establishing, Maintaining and Discontinuing a Veterinarian-Client-Patient Relationship (VCPR)
Guide to the Professional Practice Standard: Establishing, Maintaining and Discontinuing a Veterinarian-Client-Patient Relationship (VCPR)
Health Canada Policy on Extra-Label Drug Use (ELDU) in Food Producing Animals
Health Canada Categorization of Antimicrobial Drugs Based on their Importance in Human Medicine
Health Canada, Extra-Label Drug Use (ELDU) in Animals
Alberta Veterinary Medical Association Council Guidelines regarding Prescribing, Dispensing, Compounding and Selling Pharmaceuticals
College publications contain practice parameters and standards which should be considered by all Ontario veterinarians in the care of their patients and in the practice of the profession. College publications are developed in consultation with the profession and describe current professional expectations. It is important to note that these College publications may be used by the College or other bodies in determining whether appropriate standards of practice and professional responsibilities have been maintained. The College encourages you to refer to the website (www.cvo.org) to ensure you are referring to the most recent version of any document.