Extra-Label Drug Use (ELDU) – Position Statement
June 30, 2015
The CVMA holds that Extra Label Drug Use (ELDU) is an important and legal strategy in the effective and efficient treatment of animals by licensed veterinarians when an approved veterinary product is not available or suitable (1-3).
The CVMA supports ELDU when the prescribing veterinarian has evidence to support efficacy, dosage regimen, or indication for the disease and species being treated, and the circumstances of the use are in accordance with the provincial veterinary regulatory authority’s policy or guidelines.
The CVMA holds that only veterinarians are qualified to prescribe ELDU in animals and it must only be performed within the confines of a valid veterinary-client-patient relationship.
1. ELDU (often referred to as “off-label use”) is defined as the use in animals of:
i) A pharmaceutical product in a manner that is not in accordance with Health Canada’s approved label, package insert, or registration by the Canadian Food Inspection Agency or Health Canada (1-3).
ii) Any approved drug that is administered in a manner not explicitly stated on the approved label in regard to indication, dosage regimen, route or frequency of administration, duration of treatment, or target species (1-3).
iii) Any drug approved for human but not veterinary use, active pharmaceutical ingredients (API’s) (4), and compounded drugs (5).
2. Veterinarians are often faced with cases for which approved drugs are not available for the complete range of animal species and disease conditions encountered, or where ELDU may be more effective or appropriate. The CVMA supports efforts by Health Canada and the pharmaceutical industry to approve more drugs for minor food animal and non-food animal species.
3. Veterinarians play a pivotal role in the health and welfare of animals. Veterinarians have the professional training, experience, continuing education, and regulatory scrutiny to best counsel clients on the requirements and responsibilities associated with ELDU.
4. When prescribing ELDU for food-producing animals, veterinarians must provide the appropriate information on dosage regimen, route and frequency of administration, duration of treatment, and withdrawal interval to avoid a risk to food safety. It is recommended that when veterinarians prescribe ELDU with products that have a Health Canada Drug Identification Number (DIN), they consult the Canadian Global Food Animal Residue Avoidance Database (CgFARAD) for residue avoidance information. Use of a compounded product or an API in an animal intended for food may result in a “hold and test” situation at slaughter in order to demonstrate freedom from violative residues. Furthermore, veterinarians must not use any drugs that are prohibited for use in animals.
5. It is recommended that veterinarians document the extra-label use of drugs and that they obtain the “informed consent” of the owner after any risks have been explained.
6. Some antimicrobials used by veterinarians are also used in human medicine and are essential for the treatment of serious life-threatening infections in humans (Veterinary Drug Directorate Category 1 antimicrobials). ELDU of Category 1 antimicrobials is not recommended unless there has been a review and justification for their use to avoid the development of resistance (2,6).
1. Health Canada. Policy of Extra-Label Drug Use (ELDU) in Food-producing Animals. Available from: http://www.hc-sc.gc.ca/dhp-mps/vet/label-etiquet/pol_eldu-umdde-eng.php Last accessed June 23, 2015.
2. CVMA Antimicrobial Prudent Use Guidelines 2008 for Beef Cattle, Dairy Cattle, Poultry and Swine. Available to CVMA members only from: http://www.canadianveterinarians.net/documents/cvma-antimicrobial-prudent-use-guidelines-2008-for-beef-dairy-poultry-swine Last accessed June 22, 2015.
3. CVMA General Guidelines on the Prudent Use of Antimicrobial Drugs in Animals 1999. Available to CVMA members only from: http://www.canadianveterinarians.net/documents/cvma-general-guidelines-prudent-use-of-antimicrobial-drugs-in-animals-1999 Last accessed June 22, 2015.
4. Active Pharmaceutical Ingredients (API) for Veterinary Use - Position Statement. Available from: https://www.canadianveterinarians.net/documents/api-for-veterinary-use (Revised August 18, 2014) Last accessed June 22, 2015.
5. Canadian Veterinary Medical Association Guidelines for the Legitimate Use of Compounded Drugs in Veterinary Practice 2006. Available to CVMA members only from: http://www.canadianveterinarians.net/documents/cvma-guidelines-for-legitimate-use-of-compounded-drugs-in-veterinary-practice-2006 Last accessed June 23, 2015.
6. Veterinary Drug Directorate’s (VDD) Categorization of Antimicrobial Drugs Based on their Importance in Human Medicine (Table 23). Available from: http://www.hc-sc.gc.ca/dhp-mps/vet/antimicrob/amr_ram_hum-med-rev-eng.php (revised draft of 2003 document) Last accessed June 23, 2015.
(Revised June 2015)