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.
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.
"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," said Sharma, referring to an epidemic of overdose deaths in Canada.
"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.
"And the most important thing about that is this information will be consistent, so this information will be given with every opioid dispensed in Canada ... previously we didn't have a mechanism to ensure that that information was consistent across all provinces and territories."
However, the Canadian Pharmacists Association questions the use of the government-mandated stickers and handouts.
"I think we have mixed feelings, and we actually expressed our mixed feelings to Health Canada last year," said Phil Emberley, the organization's director of professional affairs.
"One of the functions of pharmacies and how pharmacists practice is that we like to individualize our communications to patients,"
he said. "So rather than treating them all as one homogenous group ... we often tailor our communications to the unique needs of patients, depending on their demographics, on what particular disorder they're being treated for.
"So we're very leery about the use of general messaging that applies to everybody without considering the needs of individual patients."
For example, the warning label and patient-information sheet could be inappropriate for people taking opioids like methadone or Suboxone to manage an addiction to the drugs, Emberley cautioned.
"To regularly tell that patient who's in treatment that this is a drug that causes addiction, dependence and overdose, I'm not sure that that's going to be in the best interest of optimizing their outcomes on the treatment program," he said.
The new regulations are part of Vanessa's Law, named after Vanessa Young, who died in 2000 at age 15 as the result of taking a
prescription drug. The law, passed in 2014, is aimed at protecting consumers from unsafe medications and reducing adverse reactions.
Wednesday's announcement marks the first time Ottawa has used the regulatory power of the legislation to place conditions on licences
to sell medications, in this case the requirement that manufacturers of the powerful painkillers provide Health Canada with a risk-management plan, including the means of monitoring for adverse events related to the drugs once they are on the market.
"Practically all of the opioids were actually approved at a time when we didn't have risk-management plans, so this is a way to have
manufacturers have the obligation that they put these plans in place and it also allows us to have consistency in our approach to the way
these products are monitored once they're on the market," Sharma said.
The plans must also contain measures to help minimize the risks to patients taking the drugs, such as training sessions about their risks and benefits for doctors and other practitioners.
"If we find that somebody isn't complying, our first step is to try to bring them into compliance, to work with the company to make sure that they're doing that," she said, noting that regulations allow for fines and penalties and even litigation for non-compliance.
Prior to the passage of Vanessa's Law, the Food and Drug Act allowed for a maximum fine of $5,000.
"Now that's gone up to millions per day."