Reserve list for antimicrobial drugs
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The issue
Antimicrobial resistant infections are becoming more frequent and difficult to treat. For this reason, they're a growing public health threat in Canada and around the world.
Health Canada authorizes antimicrobial drugs (such as antibiotics) for sale in Canada. Promoting the appropriate use of these drugs helps maintain Canada's high public health standards.
About the reserve list
Among its initiatives related to antimicrobial resistant infections, Health Canada has created a reserve list of antimicrobial drugs.
The antimicrobial drugs on the list should be reserved for treating confirmed or suspected infections from multi-drug resistant organisms. Treating them as last-resort options preserves their effectiveness, ensuring they will work when they're needed.
This list is a reference document for prescribers.
A health care provider should prescribe a drug on this list only when necessary after considering all other treatment options and weighing the clinical evidence. At least 1 of the following conditions should be met:
- all other treatment options have failed
- other treatment options are not appropriate or
- there's evidence that the infection is resistant to first or second-line treatments
By indicating which antimicrobial drugs should be used sparingly, the reserve list:
- promotes appropriate prescribing practices to avoid critical antimicrobial drugs being used unnecessarily
- raises awareness of the importance of preserving the effectiveness of antimicrobial drugs
- identifies key drugs that should be made a priority in antimicrobial stewardship programs (for example, for monitoring and reporting use)
The reserve list supports Health Canada's mandate to protect and promote the health of people in Canada. It's also part of several initiatives that the Government of Canada is undertaking in line with the Pan-Canadian Action Plan on Antimicrobial Resistance.
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
- Ertapenem
- Fosfomycin-IV
- Imipenem
- Lefamulin
- Linezolid
- Meropenem
- Polymyxin-B-IV
- Tedizolid
- Telavancin
- Tigecycline
Health Canada has authorized these drugs for use in Canada, but some may not be currently marketed here. Access the Drug Product Database to find:
- the antimicrobial drugs that are authorized for sale in Canada
- information on their availability in Canada
How we developed the reserve list
Other countries around the world use antimicrobial classification systems to help preserve the effectiveness of last-resort antimicrobial drugs. At the moment, all these systems only include antibacterials in their classifications.
Health Canada modelled Canada's reserve list after the reserve category of the World Health Organization's (WHO) AWaRe classification system. WHO's 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 antimicrobial drugs for human medicine
- Reserve antibiotics: only to be used when all alternative antimicrobial drugs have failed
We also examined the classification systems used in England and Australia. We put together a draft list of all antibacterials classified as "reserve" and "watch" by WHO, England and Australia.
We cross-referenced WHO's list with our Drug Product Database to include only antibacterials that we have authorized for sale in Canada. Next, we refined the list after looking at Canadian antimicrobial use and antimicrobial resistance data and consulted experts across Canada, such as:
- internal experts from Health Canada and the Public Health Agency of Canada
- members of the Association of Medical Microbiology and Infectious Disease
- external experts such as infectious disease physicians and hospital pharmacists
We then asked for public feedback by holding a consultation for 60 days from August to October 2023. We used this feedback to finalize the list.
Criteria considered in the reserve list includes:
- antibacterials that have received regulatory approval by us
- the presence of emerging or established antimicrobial resistance 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:
- other classes of antimicrobial drugs (such as antifungals, antivirals, antiparasitics)
- antimicrobial drugs used as first or second-line treatments
- the toxicity or tolerability of the antimicrobial drug
- antibacterials that have received regulatory approval in other international jurisdictions but not in Canada
Updates to the list
We will update the list 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
Contact us
Contact us if you would like a summary of the feedback we received when developing the reserve list or if you have questions or comments.
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Address Locator: 3105A
Health Canada
Ottawa ON K1A 0K9
Email: amr-ram@hc-sc.gc.ca
Related links
Health Canada
- Pan-Canadian Action Plan on Antimicrobial Resistance
- Canadian Antimicrobial Resistance Surveillance System (CARSS) dashboard
International
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