Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT)

Announcement of meeting

Ottawa, Ontario
6 October 2016

This Notice announces a forthcoming meeting of Health Canada's Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT).

The purpose of this meeting is to obtain advice on the fluoroquinolone class of antibacterial drugs with regard to their appropriateness for treating certain infections and their potential association with persistent and disabling events. The panel's advice will inform further steps, if any, to be taken by Health Canada, which may include broader consultation with respect to potential revisions to the labelling of systemic fluoroquinolone products currently marketed in Canada.

Mandate of the SAP-AIT

To provide timely scientific, medical and clinical advice on issues related to the safety and efficacy of anti-infectives, raised by Health Canada.

For more details, please refer to the Terms of Reference of the SAP-AIT at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/ait/sap-tor-ait-tai-ccs-ea-eng.php

Meeting format

Health Canada will make a brief presentation to the panel, in a closed meeting, summarizing background information, to provide context for the questions posed.

On completion of the presentation and associated discussion, the panel will deliberate in a closed meeting before providing their final advice to Health Canada.

Agenda

The detailed agenda for the workshop is posted at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/ait/sap-a-ait-tai-ccs-o-eng.php

Health Canada wishes to evaluate the fluoroquinolone class of antibacterial drugs with regards to their appropriateness for treating certain infections and their potential association with persistent and disabling events.

Therefore the questions to be posed to the SAP-AIT are as follows:

Based on your clinical experience, the current medical literature, actions taken in other jurisdictions (for example, United States Food and Drug Association), ongoing concerns related to antimicrobial resistance, and the information provided by Health Canada (including background documents), please consider the following:

1. Safety: Persistent Disabling Events
   1. What is the SAP-AIT's position on how the potential persistent disability associated with various types of adverse events reported during systemic fluoroquinolone treatment should be labelled in the respective Canadian Product Monographs?
   2. Are there other risk mitigation measures that could be considered to optimally address this safety concern?
   3. Would the proposed labelling and any other proposed risk mitigation measures be applicable for all systemic fluoroquinolone products marketed in Canada?
      
2. Acute Bacterial Sinusitis Indication
   
   Would you support removal of the acute bacterial sinusitis indication from all fluoroquinolone Product Monographs?
   
3. Acute Bacterial Exacerbations of Chronic Bronchitis Indication (ABECB)
   1. Would you support restriction of this indication (in all fluoroquinolone Product Monographs) to use in sick/hospitalised patients with moderate to severe ABECB?
   2. If yes, would you support this indication for use for both the IV and the oral preparations of fluoroquinolones?
      
4. Uncomplicated Acute Bacterial Cystitis Indication
   
   Would you support limiting the acute cystitis indication (in all fluoroquinolone Product Monographs) to use in those patients where there is no alternative treatment option and where there is an identified pathogen that is sensitive to the fluoroquinolone in question?
   
5. Acute Uncomplicated Gonorrhea Indication
   
   Would you support limiting the gonorrhea indication in all fluoroquinolone Product Monographs to:
   1. use in those patients where antimicrobial susceptibility testing is available and quinolone susceptibility is demonstrated?
   2. where local quinolone resistance is under 5% and a test of cure can be performed; as per the Public Health Agency of Canada Guidelines on Sexually Transmitted Infections (July 2013)?

Opportunity to comment:

If you wish to provide input on the above questions, please send your comments, numbered to correspond with the questions being commented on, by 23 September 2016. Contact information is provided below. All comments will be taken into consideration in the development of Health Canada's positions on the issues above.

Contact Information:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Holland Cross, Tower B, 2nd Floor
Address Locator: 3102C1
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca