Notice to stakeholders: Post-market re-evaluation of medically important antimicrobials for veterinary use with unspecified or prolonged durations of use

Background

Antimicrobial resistance (AMR) is a complex and evolving public health issue, involving many players in Canada and internationally. Health Canada's Veterinary Drugs Directorate (VDD) is taking a multi-pronged approach to address AMR aimed at preserving the effectiveness of antimicrobials. We have made significant progress to increase regulatory oversight of antimicrobials available for use in animals and have collaborated with stakeholders including the pharmaceutical industry, veterinarians and food animal producers on key policy measures that promote their responsible use.

The next phase of this work focuses on re-evaluating labels of antimicrobials for use in animals that do not align with responsible use principles. Specifically, it will include work to re-evaluate product labels of medically important antimicrobials (MIAs) with unspecified or prolonged durations of use. Similar post-market initiatives are being conducted internationally and the VDD is learning from these initiatives and incorporating lessons learned and best practices within our own approach.

The VDD remains committed to advancing work on responsible use, while still maintaining access to safe and efficacious antimicrobials on the Canadian market. This re-evaluation work will be an iterative process, incorporating stakeholder feedback at each stage.

General approach to re-evaluation

The re-evaluation framework, published in 2020, will be used as the foundation for this project. This work will continue to use a step-wise approach with ongoing engagement, and will take into account industry perspectives and the Canadian context. The scope includes the following:

• Product labels with one or more indications with either an unspecified or prolonged duration of use as it relates to responsible use;
• Antimicrobials authorized for veterinary use belonging to List A and/or belonging to Categories I, II and III.

An initial review conducted by the VDD, identified approximately 100 products, containing 18 active ingredients that would fall within the scope of this initiative. The majority of the products belong to Categories II and III. The list will continue to be refined and updated as additional analysis is conducted by VDD. The preliminary list includes the following active ingredients:

• Amoxicillin
• Avilamycin
• Bacitracin
• Chlortetracycline
• Diethanolamine fusidate
• Framycetin
• Lincomycin
• Neomycin
• Oxytetracycline
• Penicillin G
• Polymixin B
• Spectinomycin
• Sulfonamides
• Tetracycline
• Tiamulin
• Tilmicosin
• Tylosin
• Virginiamycin

Next steps

The preliminary list of products identified for this project will undergo further review by VDD as it relates to their directions of use. Stakeholder consultation and feedback will be fundamental to this re-evaluation process. Implicated stakeholders will be contacted in the coming weeks and months for more targeted engagement on the VDD's analysis, findings to date and timelines for the initiative.

If you have any questions, contact Health Canada's Veterinary Drugs Directorate by email at vdd.HSD-DIH.dmv@hc-sc.gc.ca.