Scientific Advisory Panel on Isotretinoin Risk Management (SAP-IRM)

Announcement of meeting

Ottawa, Ontario
17 November 2017

The purpose of this Notice is to announce an upcoming meeting of Health Canada’s Scientific Advisory Panel on Isotretinoin Risk Management (SAP-IRM).

This meeting will re-examine the effectiveness of the current Canadian pregnancy prevention measures implemented to mitigate the serious risk of birth defects associated with isotretinoin use in women of childbearing age.

Mandate of the SAP-IRM

To provide timely scientific, medical and clinical advice on measures to mitigate the risk of birth defects associated with isotretinoin use in women of childbearing age.

For more details, please refer to the Terms of Reference of the SAP-IRM.

Meeting format

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

Upon 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 meeting will be posted at a later date.

Considering the available Canadian and international evidence, Health Canada is seeking expert advice on the following:

1. What would be the criteria to consider when assessing the effectiveness of a pregnancy prevention program for isotretinoin?
   1. Is the rate of pregnancy among female isotretinoin users the optimal indicator?
   2. Given that no program has been effective in preventing all pregnancies, what would be a realistic threshold for determining the success of a pregnancy prevention program?
   3. Should there be other criteria to consider? Please provide the rationale.
2. Based on the discussion for question 1, is the current Canadian pregnancy prevention program effective?
3. Should additional measures be considered to strengthen the Canadian pregnancy prevention program?
   1. Is there a need to strengthen the educational material for prescribers?
   2. Should there be improvement to the current informed consent form signed by the patient?
   3. Should there be other measures to consider? Please provide the rationale.
4. Are there additional or alternative risk mitigation measures that could be considered to prevent pregnancy?