Questions for the Scientific Advisory Panel on Opioid Use and Contraindications (SAP-OUC)

March 24, 2017

1. Specific to the threshold dose:
   1. Should a threshold dose (50 and/or 90 morphine milligram equivalents), as discussed in the recommendations of the new proposed Canadian guideline on the use of opioids for chronic non-cancer pain, be included in the Product Monograph (PM)?
   2. Where should the information on the threshold dose be included in the PM (e.g. in the Warnings and Precautions or Dosing and Administration section)?
   3.  Should the threshold dose information be emphasized by bolding it or placing it in a box?
   4. Do you think it should be specified that the threshold dose does not apply in end of life care, cancer pain and other similar situations, or is this self-evident?
2. Specific to the indication and clinical use:
   1. Do you think the current indication for the extended/long-acting opioids^{Footnote 1} is clearly worded and in line with the recommendations in the new guidance (i.e., opioids should not be considered as a first line treatment)? Should the indication be reworded to put more emphasis on the fact that opioids are not first line therapy?
   2. Do you think the indication for immediate release opioids^{Footnote 1} should limit the duration of use (e.g. to 7 or 14 days), and consequently the amount of medicine that should be dispensed to patients?
   3. Should dosing instructions for stopping the opioid treatment after a few days to evaluate the need to continue treatment, be part of the PM?
   4. Should a recommendation to consider tapering patients who are using chronic high doses of opioids be added to the PM?
   5. Some studies have shown that opioids have marginal efficacy when used for lower back pain. Should information from these published articles be added to the PM?
3. Specific to contraindications:
   1. In addition to the current contraindications and in light of the draft guideline recommendations, should there be a contraindication or a relative contraindication for patients with:
   2. A history of addiction?
   3. An uncontrolled mental illness?
   4. Is the contraindication on Labour, Delivery and Nursing Women compatible with the practice of medicine (i.e. use of opioids during labour and delivery)^{Footnote 3} and with the language used in the Warnings and Precautions^{Footnote 4}?
   5. Are there any other contraindications, relative contraindications, or limitations in use that you feel are missing and should be added to the PM?
   6. Does the information in the PM provide prescribers and patients with adequate/sufficient information on the risks of opioids?
   7. There are situations where potential contraindications or limitations should perhaps not apply (e.g. trauma or cancer in a patient with previous addiction problems). Do you think that these situations are self-evident, or should they be described in the PM?
4. Specific to low-dose codeine products:
   1. Currently, low-dose codeine products are exempted from the Controlled Drugs and Substances Act (CDSA) and can be obtained without a prescription. Do you believe there would be merit in making these products prescription only, considering: the risks and benefits for patients, the impact it could have on patients and the health care system, etc.?