Notice - Antimicrobials Product Labelling
November 16, 2015
Our reference number: 15-112507-157
Responding to the threat of Antimicrobial Resistance (AMR) has been at the forefront of recent international discussions due to the increasing concern of resistance to antibiotics for infections that were previously easily treatable.
The Government of Canada is committed to taking a leadership role both nationally and internationally in preventing, limiting and controlling the emergence and spread of AMR, as described in its' Federal Action Plan on AMR and joining international efforts to develop an integrated and global package of activities to combat AMR that will raise awareness among health care professionals, patients and the public of the importance of prudent use of antimicrobials.
The Government of Canada is engaged in efforts to facilitate and enhance education and awareness nationally on when and how to use antimicrobials, as well as the choice of the correct antimicrobials to use for treatment.
Health Canada will now require the inclusion of precautionary statements in product labelling to encourage the prudent prescribing and use of antimicrobials. This requirement will be implemented as explained further below. The required wording for Parts I and III of the sponsors' product monograph is as follows:
Part I: Indications and Clinical Use
"To reduce the development of drug-resistant bacteria and maintain the effectiveness of Product X and other antibacterial drugs, Product X should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy."
Part I: Warnings and Precautions
"Prescribing Product X in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria."
Part III: Patient Medication Information
"Antibacterial drugs like Product X treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Product X should be taken exactly as directed. Misuse or overuse of Product X could lead to the growth of bacteria that will not be killed by Product X (resistance). This means that Product X may not work for you in the future. Do not share your medicine."
To implement the standard wording described above, Health Canada is requesting that sponsors proceed as follows:
- The product monograph of existing antibiotics will be updated in a phased manner in response to a specific request by Health Canada to the relevant sponsor.
- Health Canada will be sending an advisement letter to sponsors in a phased manner over the coming months to request a labelling update. Sponsors will be requested to update their labelling, including revising the Part III into the new Patient Medication Information format or developing a Part III if one does not exist.
- Sponsors should wait until they receive the request from Health Canada so as to facilitate workload management.
- Sponsors however may update their product monograph(s) if a submission is being filed for other reasons than the inclusion of the precautionary AMR statements. Sponsors of products that do not have a Prescribing Information document and/or a Part III: Patient Medication Information component, should create one and file it with their submission.
- Submissions for all new active substance antimicrobials should include the precautionary statements at the time of filing.
Should you have any general questions or concerns about this initiative, please contact the Bureau of Gastroenterology, Infection and Viral Diseases at:
Sponsors may contact the Regulatory Project Manager for the Division of Anti-infective Drugs at 613-948-7825.
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