Health Canada To Put Much Needed Warnings On Opioid Medications

by | May 25, 2018 | Canadian Regulatory | 0 comments

Opioids medications are known to effectively relieve many patients of pain. They include drugs such as oxycodone, morphine, fentanyl and codeine, and are available through prescription administration only and vary in strength of pain relief. However, the use of opioids could lead to great risks such as dependence, substance abuse, overdose and even death. In Canada, the use of prescription opioids has increased by 203% from 2000 to 2010. This, along with a recent influx of illegal opioids, has resulted in an increase in opioid addiction which typically resulted in overdose and, in some cases, death.

Health Canada is working to address the opioid crisis which includes developing many risk-management plans and recently released new regulations that warns Canadians of the risks associated with opioid drugs. These regulations include providing patients with clear information on opioid safety and the risks surrounding consistent use. This includes yellow warning stickers on the packaging of prescription opioid medications as well as providing a patient information handout that will accompany the drug that will provide clear precautionary information on the risks of opioid use. Health Canada will also require drug companies to develop risk-management plans. Under these plans, drug manufacturers will collect and monitor information about the use of their products, and this data will be used to reduce potential harm associated with the use of opioid drugs.

These new regulations have been met with positive views from many non-profit organizations hoping that emphasizing the risks surrounding opioid use will make patients aware of the potential harm caused by the use of opioids. These changes will affect all prescription drug products containing any opioid as the active ingredient. Opioid drug packaging with the warnings and the handouts will be effective as of October 2018.

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory consultants for OTC Drugs and other products regulated by Health Canada.