Health Canada seeks feedback on the Canadian Access, Watch, Reserve classification of antimicrobial drugs for human use: Notice

On this page

• The issue
• About the Canadian Access, Watch, Reserve classification
• What Health Canada is proposing
• Seeking your feedback
• Contact us

The issue

Antimicrobial (antibiotic)resistant infections are becoming more common and harder to treat. Antimicrobial resistance (AMR) arises when bacteria or other microbes change so that medicines no longer work to kill them or to stop their growth. As a result, AMR is a growing public health threat in Canada and internationally.

Antimicrobial drugs, like antibiotics, are essential for treating infections. But as AMR grows, these medicines are becoming less effective. One of the best ways to slow the development and spread of resistance is to reduce the use of antimicrobials when they aren’t necessary or appropriate. While it’s important to avoid using these medicines when they aren’t needed, many infections still do require timely and appropriate treatment.

Antimicrobial stewardship (AMS) promotes the responsible use of antimicrobials to help preserve their effectiveness. Globally, several antimicrobial classifications have been created to support stewardship by grouping antimicrobials into tiers, from those recommended for common infections to those that should be reserved for treating infections caused by highly resistant organisms.

Health Canada authorizes antimicrobial drugs for sale in Canada and plays a central role in supporting their responsible use. To further strengthen stewardship across the country, we have developed a national antimicrobial classification and are now seeking feedback on the proposed classification.

About the Canadian Access Watch Reserve classification

In support of federal AMS efforts and the Pan-Canadian Action Plan (PCAP) on AMR, Health Canada is developing a national antimicrobial classification called Canadian Access, Watch, Reserve (CAN-AWaRe). CAN-AWaRe classifies antimicrobials for human use into three stewardship categories, Access, Watch, Reserve, adapted from the World Health Organization’s (WHO) AWaRe framework to reflect Canada’s AMR context.

CAN‑AWaRe classifies antimicrobials authorized for use in Canada into these three categories using Canadian‑adapted definitions:

• Access: antibacterials that have a relatively narrower spectrum of activity and for infections with generally low resistance potential. They are often recommended as empiric first or second-choice treatment options for common infections. These antibacterials should offer the best therapeutic value, for generally lower cost, and with more ease of access, while minimising the potential for resistance and side effects.
• Watch: antibacterials that are broader-spectrum and generally have a higher resistance potential. They are generally recommended as first-choice options for a limited list of infectious syndromes and usually for patients with more severe clinical presentations or for infections where the causative pathogens are more likely to be resistant to Access antibacterials.
• Reserve: antibacterials, including new molecules, reserved for treating confirmed or suspected, often life-threatening, infections from multi-drug resistant organisms. They are recommended only as last-choice options after considering all other treatment options and weighing the clinical evidence. At least 1 of the following conditions should be met:
  • All other recommended treatment options have failed.
  • Other treatment options are not appropriate.
  • There's evidence that the infection is resistant to first or second-line treatments.

What is included and excluded

CAN-AWaRe only includes antibacterials that have received regulatory approval from Health Canada. It does not consider other classes of antimicrobial drugs (such as antifungals, antivirals, antiparasitics), nor does it include antibacterials that have received regulatory approval in other international jurisdictions but are not authorized in Canada, including those accessible through Health Canada’s Special Access Program.

CAN-AWaRe excludes antibacterials that are only available in Canada as inhaled, topical and/or ophthalmic formulations due to insufficient evidence of systemic absorption and their overall impact on AMR. Although these are excluded from CAN-AWaRe, it is acknowledged that the use of these formulations may contribute to AMR and should be used responsibly. In some cases, oral and intravenous (IV) formulations of the same antibacterial are classified differently to reflect differences in stewardship considerations.

What Health Canada is proposing

The CAN-AWaRe includes 65 antibacterial agents approved by Health Canada, of which 18 are proposed to be classified to the Access category, 27 to the Watch category, and 20 to the Reserve category.

How we developed the classification

We cross-referenced the WHO AWaRe list with Health Canada’s Drug Product Database to include only antibacterials that we have authorized for sale in Canada. Initial classifications were assigned after reviewing antimicrobial classifications available internationally, such as in the UK, Australia and France, and domestically, such as in British Columbia. We also considered Canadian antimicrobial use and antimicrobial resistance data and sought input from internal experts from Health Canada and the Public Health Agency of Canada.

We then refined the classification with input from a multi-disciplinary external expert group representative of provinces and territories, with experience in antimicrobial stewardship across hospital and community health care settings, including infectious disease physicians, academics, pharmacists, nurse practitioners and dental professionals. To gather input, we first circulated a questionnaire to identify areas of agreement and disagreement. We then convened a virtual meeting to achieve consensus. Finally, we validated the resulting classifications with additional experts, including members of the Association of Medical Microbiology and Infectious Disease.

The expert-validated CAN-AWaRe classification includes 12 antibacterials out of 65 where the Canadian category differs from the WHO AWaRe classification. The proposed modifications and supporting rationales are summarized in the following table.

Summary of antibacterial reclassification and supporting rationales

Antibacterial	WHO AWaRe category	CAN-AWaRe category	Rationale
Amikacin	Access	Reserve	Broader-spectrum activity than other aminoglycosides; used to treat multi-drug resistant (MDR) gram negative infections.
Chloramphenicol	Access	Reserve	Broad-spectrum activity and low resistance rates due to infrequent use because of toxicity; maintaining as a ‘Reserve’ option ensures availability when resistance to more tolerable antibacterials arises.
Amoxicillin/clavulanic-acid	Access	Watch	Broad-spectrum with higher resistance potential and frequent overuse for common infections; should be limited for specific indications to encourage appropriate, targeted use with preference for narrower spectrum options.
Clindamycin	Access	Watch	Primarily used for more serious infections and requires caution because of possible inducible resistance; associated with higher risk of Clostridium difficile infection (CDI).
Gentamicin	Access	Watch	Primarily used for more serious infections and infrequent use due to toxicity.
Erythromycin	Watch	Access	Narrower spectrum than clarithromycin and azithromycin; provides primarily Gram-positive coverage; infrequent use due to adverse effects, which limits overall impact on resistance.
Vancomycin oral	Watch	Access	First-line treatment for CDI, noting that Vancomycin IV is classified as ‘Watch’.
Delafloxacin	Watch	Reserve	Broad-spectrum activity; better methicillin-resistant Staphylococcus aureus (MRSA) coverage than other fluoroquinolones.
Ertapenem	Watch	Reserve	Important to limit selection for carbapenem resistant organisms which is a growing public health threat in Canada. Carbapenems are critical for the treatment of MDR infections, and classifying them as ‘Reserve’ helps protect their effectiveness by encouraging appropriate, targeted use.
Imipenem/cilastatin	Watch	Reserve
Meropenem	Watch	Reserve
Streptomycin IV	Watch	Reserve	Primarily used for MDR infections.

Why we developed the classification

Compared to the WHO’s global AWaRe framework, CAN-AWaRe is tailored to Canada’s national AMR context. It includes only medicines that are authorized in Canada and takes into account Canadian antimicrobial use, resistance patterns and stewardship priorities. This is important to ensure the AWaRe framework is relevant and actionable in Canada.

Publishing the final CAN-AWaRe will fulfill Canada’s commitment to promote the appropriate use of antimicrobials for human use through the application or adaptation of the WHO’s AWaRe classification within national contexts. This commitment was articulated in the United Nations General Assembly political declaration following the 2024 high-level meeting on AMR. It will also address the Office of the Auditor General’s 2023 recommendation to publish an expanded classification of antimicrobial drugs for human use, replacing the Canadian reserve list for antimicrobial drugs, and will support Health Canada’s contribution to stewardship actions under the PCAP on AMR.

How the classification will be used

CAN‑AWaRe will be a national-level AMS reference tool for prescribers and other health care professionals, health care program leads, policy makers and researchers. It will support and strengthen standardized AMS programs at the provincial, territorial, municipal, and local levels, including identifying which medicines that should be prioritized for stewardship.

CAN-AWaRe will be used in the development and maintenance of national prescription guidelines for antibiotics. It will also be integrated into Canadian monitoring and surveillance activities, enabling jurisdictions to track antimicrobial use patterns in a more consistent and comparable manner. CAN-AWaRe can also inform audit and feedback initiatives and educational and training programs to optimize prescribing practices in both community and hospital settings.

Once published, we will update the classification as needed to reflect the latest antibacterial drugs that we have authorized for sale in Canada. We will review the list periodically to consider:

• emerging information on antimicrobial use and resistance rates in Canada
• changes to other international antimicrobial classification schemes

Seeking your feedback

We are looking for feedback from stakeholders and the public about the proposed CAN-AWaRe classifications.

Visit the consultation to learn how you can participate.

Contact us

If you have any questions or comments about this notice, email the Pharmaceutical Drugs Directorate at amr-ram@hc-sc.gc.ca.

Related links

Domestic

• Pan-Canadian Action Plan on Antimicrobial Resistance
• BC Provincial Antimicrobial Clinical Expert Committee (PACE) Antimicrobial Prioritization Scheme (only in English)
• Reports of the Auditor General of Canada: Report 6 Antimicrobial Resistance

International

• AWaRe classification of antibiotics for evaluation and monitoring use, 2023 (WHO)
• Priority antibacterial list for antimicrobial resistance containment (Australia) (only in English)
• UK Access, Watch, Reserve, and Other classification for antibiotics (UK-AWaRe antibiotic classification) (only in English)
• Actualisation de la liste des antibiotiques critiques disponibles en France pour l’exercice libéral et en établissements de santé (only in French)
• Political Declaration of the High-Level Meeting on Antimicrobial Resistance: resolution adopted by the United Nations General Assembly