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


  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 an 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?

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