2022 Compliance monitoring project: Canadian Specific Opioid targeted Risk Management Plans (CSO-tRMPs) for prescription opioid-containing products
We identified a need for more oversight of prescription opioids to increase patient safety. In this project, we verified that market authorization holders had implemented the required CSO-tRMPs.
On this page
What we did
Based on selective criteria, we visited 8 (16%) of market authorization holders (MAHs) of prescription opioid-containing products, who submitted CSO-tRMPs, to verify that they are following their plans to manage opioid-related harms of these drugs, such as, but not limited to, addiction, abuse and misuse.
What we found
Six of 8 MAHs had 1 or more findings. Examples of these findings included:
- missing or incomplete procedures in the management and submission of CSO-tRMPs
- missing evidence that staff were adequately trained on relevant procedures related to CSO-tRMPs
- some MAHs had:
- removed or changed activities in their CSO-tRMPs without informing us
- not implemented some or all measures in their CSO-tRMPs
What enforcement actions we took
We did not identify an immediate risk to the health of people in Canada during our visits.
We worked with MAHs to resolve the issues identified through corrective actions.
During the inspection process, and based on inspection findings, we provided guidance to inspected MAHs so they could better comply with the requirements and improve their implementation of their CSO-tRMPs.
No additional enforcement actions were needed, as missing activities were implemented in a timely manner by MAHs once identified.
Related links
- Health product complaint
- Monitoring health products on the Canadian market
- Compliance and enforcement policy for health products (POL-0001)
- Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products
- Regulations Amending the Food and Drug Regulations (Opioids)