The potential for harm associated with opioid drugs and the growing related public health crisis is the subject of increasing concern for Canadians and other levels of government in Canada. Health Canada has identified the need for strengthened post-market oversight of opioids to help monitor and mitigate their risks, and the need for patients to receive additional, clear information about the safe use of opioids and the risks associated with their use.

The proposed amendments to the Food and Drugs Regulations would expressly permit the Minister of Health to add or amend terms and conditions to an authorization for the sale of an opioid. This authority could then be used by the Minister to compel an opioid authorization holder to develop and implement a risk management plan to appropriately monitor, quantify, characterize and mitigate the risks associated with post-market use of these products. The proposed amendments would also require that a patient information handout and warning sticker accompany prescription opioids at the time of sale.