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A national summary of what is currently known about the Canadian opioid crisis with respect to opioid-related deaths and harms and potential risk factors as of December 2017.

The COVID-19 pandemic is adding to the ongoing public health crisis related to high rates of opioid overdose and deaths, as well as acute substance use harms. These crises are made worse in communities where there is chronic overcrowding, including a shortage of housing or other shelters.

The COVID-19 pandemic is adding to the ongoing public health crisis related to high rates of opioid overdose and deaths, as well as acute substance use harms. These crises are made worse in communities where there is chronic overcrowding, including a shortage of housing or other shelters.

The purpose of this Notice is to notify stakeholders that Health Canada has made changes to the opioid patient information handout entitled “Opioid Medicines – Information for Patients and Families”. Canada's Food and Drug Regulations were recently amended to require that a warning sticker and patient information handout be provided to patients, at the time of sale, with all prescription opioids that appear in Part A of the “List of Opioids”.

In keeping with the Government’s public-health centred approach to substance use and the opioid epidemic, the Minister of Justice introduced Bill-C-22.

Health Canada has identified the need for patients to receive clear information about the safe use of opioids and the risks associated with their use. As such, requirements have been added, under the Food and Drug Regulations, for a warning sticker and patient information handout to be provided with all prescription opioids that appear in Part A of the “List of Opioids”, at the time of dispensing.

The Public Health Agency of Canada (PHAC) released new modelling projections of the number of opioid-related deaths that may occur over the course of the coming months. The results of the model suggest that, under some scenarios, the number of opioid-related deaths may remain high or may even increase through to December 31, 2021.

opioid- and other drug-related overdose deaths have increased sharply and become a significant cause of mortality in Canada. In response, local governments, provinces, and territories have implemented a variety of interventions and the Government of Canada has committed to a targeted public health response

"The opioid crisis has affected every part of the country, but there are clear differences in death rates and the substances involved across provinces and territories. According to data reported as of March 22, 2018:

in 2016, there were 2,946 apparent opioid-related deaths in Canada
88% were accidental (unintentional)
from January to September 2017, there were at least 2,923 apparent opioid-related deaths; 92% were accidental
72% of accidental apparent opioid-related deaths involved fentanyl or fentanyl analogues, compared to 55% in 2016
most accidental apparent opioid-related deaths occurred among males (76%) and among individuals between the ages of 30 and 39 (28%)
it is expected that these numbers will change as additional data become available"

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when sponsors seek to obtain approval for controlled-release opioid drug formulations with tamper-resistant properties and wish to include, in product monographs, scientific statements and claims regarding tamper-resistance.