It is the first time the federal government has issued regulations requiring a warning sticker and a patient handout for a medicine dispensed by a pharmacy.
Heath Canada announced today that starting in October, all prescription opioids must carry a warning sticker about potential adverse effects and pharmacists will be required to provide information handouts to consumers about the potent narcotics.
Dr. Supriya Sharma, Health Canada’s chief medical adviser, said the yellow warning sticker will be applied to the container and state that the medication can cause dependence, addiction and overdose.
The handout will include information about the signs of opioid overdose and potential side-effects, as well as warnings not to share the medication and to store it safely out of the reach of children.
The new regulations also require pharmaceutical companies to develop and implement risk-management plans aimed at reducing the potential harms associated with the use of the drugs.
Sharma said, “While much of the opioid crisis can be attributed to contaminated drugs that have been obtained illegally, prescription opioids have also contributed to this issue.”
“We want patients to have ongoing conversations with their health-care providers and pharmacists about the risks and the benefits of prescription opioids,” she told a media briefing from Ottawa. “These stickers and handouts will help continue those conversations.”
Sharma said the sticker will act as a red flag every time a consumer uses an opioid, a visual warning that the medication carries the potential for significant risk, backed up by the single-sheet information handout.