Proposed Regulations Amending the Food and Drug Regulations (Opioids)
Project InformationDue Date:
CSHP received an invitation to provide feedback about the proposed amendments to the Food and Drugs Regulations, affecting the sale of opioids.
As taken from the Government of Canada’s notice in the Canada Gazette,
“the proposed amendments would expressly permit the Minister of Health (the Minister) 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. (http://www.gazette.gc.ca/rp-pr/p1/2017/2017-06-17/html/reg8-eng.php)
The Regulatory Impact Analysis Statement and proposed regulations are available at http://www.gazette.gc.ca/rp-pr/p1/2017/2017-06-17/html/reg8-eng.php. The draft warning sticker and patient information handout, as well as a list of prescription opioids to which those provisions would be applied, are also provided on the same webpage.
Your comments on the proposed regulations are welcome. As you read the proposed regulation, it might be helpful to identify the instances where patients in your hospital receive opioids to take outside the hospital, such as pass medications, or bridge supplies of medications (e.g., to ease the transition from hospital to community).
Please send your feedback to me, to firstname.lastname@example.org by August 17, 2017.