Health Canada seeks feedback on antimicrobial reserve list: Notice
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This is an archived list. Please refer to the most current version of this list.
August 31, 2023
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The issue
Antimicrobial (also known as antibiotic) resistant (AMR) infections are becoming more frequent and difficult to treat. As a result, AMR is a growing public health threat in Canada and around the world.
Health Canada authorizes antimicrobial drugs (such as antibiotics) for sale in Canada. By promoting the appropriate use of antimicrobial drugs, we help maintain Canada's high public health standards.
About the reserve list
The 2021 federal budget funded several initiatives related to AMR, including developing a Canadian reserve list of antimicrobial drugs.
The antimicrobial drugs chosen for the reserve list are those that should only be used as last-line treatment options. Last-line treatment options are appropriate when:
- all alternative treatment options have failed
- alternative treatment options are not appropriate or
- there is documented evidence that the infection is resistant to first and second-line treatment options
The reserve list will provide clear guidance to prescribers on which antimicrobial drugs to use sparingly to preserve effectiveness. Preserving the effectiveness of antimicrobial drugs is important so that these drugs work when they are needed to treat AMR infections.
The reserve list supports Health Canada's mandate and core responsibilities to protect and promote the health of people in Canada. The list is part of a range of initiatives being undertaken by the Government of Canada in line with the Pan-Canadian Action Plan on Antimicrobial Resistance.
The purpose of this consultation is to request feedback from stakeholders and the public on the antimicrobial drugs that will be included in the reserve list.
What's included in the reserve list
The reserve list includes the following antimicrobial drugs (in alphabetical order):
- Aztreonam
- Ceftobiprole-medocaril
- Ceftolozane/tazobactam
- Colistin_IV
- Dalbavancin
- Daptomycin
- Fosfomycin_IV
- Polymyxin-B_IV
- Telavancin
- Tigecycline
We're also seeking feedback on other antimicrobial drugs that we're considering including in the reserve list:
- Cefepime
- Ertapenem
- Imipenem
- Linezolid
- Meropenem
We will update this list periodically based on antimicrobial use, antimicrobial resistance data and availability of antimicrobial drugs in Canada.
How we developed the reserve list
Antimicrobial classification systems are used internationally to help preserve the effectiveness of last-resort antimicrobial drugs. To date, all international antimicrobial classification schemes only include antibacterial drugs in their classifications.
Health Canada modelled the Canadian reserve list after the Reserve category of the World Health Organization's (WHO) AWaRe classification system. This classification system has 3 categories of antibiotics:
- Access antibiotics: should be widely available, affordable and of high quality
- Watch antibiotics: recommended only for specific, limited indications
- includes most of the highest priority critically important antimicrobials for human medicine
- Reserve antibiotics: only for use in situations where all alternative antimicrobials have failed
We also examined the classification systems used in the United Kingdom (UK) and Australia. We assembled an initial comprehensive list of all antibacterials classified as Reserve and Watch by WHO, the UK and Australia.
To tailor the reserve list to the Canadian context, we cross-referenced the reserve list with the Drug Product Database to include only antibacterials that are currently available in Canada. We then refined the reserve list according to Canadian antimicrobial use and AMR data, and consulted with Canadian subject matter experts, such as:
- internal experts from Health Canada and the Public Health Agency of Canada (PHAC)
- members of the Association of Medical Microbiology and Infectious Disease (AMMI)
- an external group of subject matter experts that included infectious disease physicians and hospital pharmacists from across Canada
Criteria considered in the reserve list includes:
- the presence of emerging or established AMR to the antimicrobial drug
- the antimicrobial drug's susceptibility to resistance
- if the antimicrobial drug treats existing or emerging infections of concern
Criteria not considered in the reserve list includes:
- antimicrobial drugs used as first or second-line therapy
- the toxicity or tolerability of the antimicrobial drug
- the availability and accessibility of the antimicrobial drug in Canadian regions
Contact us
Health Canada is looking for feedback from stakeholders and the public about the antimicrobial drugs that are:
- in the reserve list
- listed for consideration but not currently in the reserve list
- not included in either list but should be considered
Please give your rationale and provide supporting evidence.
You may provide your feedback through an online questionnaire or by email or mail. You may also contact us if you have questions.
Visit the consultation page for more information on how to participate.
Related links
Health Canada
- Pan-Canadian Action Plan on Antimicrobial Resistance
- Canadian Antimicrobial Resistance Surveillance System (CARSS) report 2022
International
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