TORONTO — Health Canada is making warning stickers and patient information handouts mandatory with all opioids dispensed at pharmacies or in doctor’s offices starting in October.
It is the first time the federal government has issued regulations requiring a warning sticker and patient handout for a medicine dispensed by a pharmacy.
The federal department says the yellow warning sticker will state that the medication can cause dependence, addiction and overdose, and will be applied to the container being dispensed to the patient.
The patient handout will include information about the signs of opioid overdose, warnings not to share the medication and to store it safely out of reach of children, and advise about potential side-effects.
The new regulations also require pharmaceutical companies to develop and implement mandatory risk-management plans to characterize, monitor, prevent and manage risks associated with the use of opioids.
Risk-management plans will include additional activities aimed at reducing the potential harms associated with the use of prescription opioids, such as including educational materials in packaging for health-care providers.