Notice to Stakeholders: Update on Collaborative efforts to promote the prudent use of Medically-Important Antimicrobials (MIAs) in animals

This update is further to Health Canada’s April 2014 Notice to Stakeholders and April 2015 Notice of Intent regarding strengthening the veterinary oversight of antimicrobial use. This notice is to inform stakeholders about Health Canada’s policy intent for increasing veterinary oversight of Medically-Important Antimicrobials (MIAs^{Footnote 1}).

Antimicrobial resistance (AMR) is a complex and evolving public health issue, involving many players in Canada and internationally. The Government of Canada is continuing with its commitment to address AMR as outlined in its Federal Framework and the supporting Action Plan, including important regulatory and policy proposals for veterinary drugs. 

Health Canada’s Veterinary Drugs Directorate (VDD) considers having appropriate veterinary oversight to be a key measure towards promoting the prudent use of antimicrobials and minimizing the development and spread of AMR.  VDD has been actively engaging provincial/territorial authorities, the pharmaceutical industry, veterinarians, food animal producers and other stakeholders on options to strengthen veterinary oversight of MIAs used in animals.  This Notice lays a Federal foundation for further action and implementation by all sectors, including provincial/territorial authorities.

Further to engagement efforts and feedback received, the VDD is proposing to increase oversight by including all remaining MIAs for veterinary use to the Prescription Drug List (PDL). The Prescription Drug List is a list of medicinal ingredients that when found in a drug, require the drug to be sold pursuant to a prescription. Since 2004, new MIAs approved by Health Canada have been included on the PDL and must be sold pursuant to a prescription. With this proposal, Health Canada will establish the same level of oversight for those remaining MIAs approved prior to this time.

Health Canada considers that veterinarians, who prescribe for animals under their care, possess the scientific and clinical training to assess the health of animals, diagnose disease conditions, determine the need for antimicrobial drug treatment, and choose the most appropriate course of treatment.  Consequently, involving veterinarians in antimicrobial treatment decisions is an important component of enhancing antimicrobial stewardship.

With this proposal, the following MIA ingredients will be included on the PDL for Veterinary Use. Veterinary drugs in all dosage forms^{Footnote 2} containing these ingredients will require a prescription:

• Apramycin
• Bacitracin
• Lincomycin
• Penicillin G
• Spectinomycin
• Streptomycin/Dihydrostreptomycin
• Sulphonamides
• Tilmicosin 
• Tiamulin
• Tylosin/Tylvalosin
• Virginiamycin
• Tetracycline/Chlortetracycline/Oxytetracycline
• Or their salts or derivatives

As with any proposal to change the prescription status of a drug, it is recognized that there will be implications for stakeholders. This includes implementation considerations for provincial/territorial authorities, who also have regulatory oversight over the distribution and dispensing of prescription drugs. The VDD will continue to collaborate and communicate timelines with impacted parties, particularly the P/T authorities, prior to initiating the process for adding medicinal ingredients to the PDL.

For further information contact the VDD at ConsultationVDD-DMV@hc-sc.gc.ca.

Regards,

Mary Jane Ireland
Director General
Veterinary Drugs Directorate