All prescription opioids dispensed at Canadian pharmacies or doctors’ offices will soon require a bright yellow warning label and be accompanied by a handout on the risks.
Supriya Sharma, chief medical adviser for Health Canada, acknowledged that Ottawa’s latest steps to turn the tide on the country’s overdose crisis are modest, but maintained that they are important.
“We don’t think this is a silver bullet, but what we heard from patients and practitioners is that there were a lot of people going and getting their prescriptions filled not even knowing that the medication they were getting was an opioid,” Dr. Sharma said on Wednesday.
“Certainly, we’ve heard at least anecdotally that they weren’t being made aware of the significant risk that could be associated around that, speaking specifically around dependence and potential for addiction and overdose.”
The yellow stickers depict an image of a triangle with an exclamation point, along with the warning that opioids can cause dependence, addiction and overdose. The patient information handout provides more details on these warnings, along with signs of withdrawal, overdose and other possible side effects.
The new regulations will also require pharmaceutical companies to develop and implement mandatory risk-management plans to bolster the inconsistent product monitoring mechanisms in place today.
This could include registries, compulsory training sessions and other systems set up to collect data on adverse reactions.
“Practically all of these opioids were actually approved at a time where we didn’t have risk-management plans,” Dr. Sharma said. “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 that these products are monitored once they’re on the market.”
The regulations were published in Canada Gazette on Wednesday and will go into effect in October.
Petra Schulz lost her adult son to a fentanyl overdose in 2014 and has since become a vocal drug-policy and harm-reduction advocate with the group Moms Stop the Harm. She said the group fully supports the warning sticker and informational handout, but feels that not including a separate sheet providing more details on overdoses and naloxone − a drug that reverses the effects of an opioid overdose − is a missed opportunity.
The group is also of the position that people who are prescribed high potency opioids such as oxycodone and hydromorphone should be offered naloxone kits at the same time. Ms. Schulz noted that first-time opioid users may not be aware of the risks of mixing medications, seniors may be confused about dosage and some might not store their medications properly, leading to diversion – all of which present overdose risks.
“Many of these situations can lead to an overdose event where a naloxone kit is essential to reverse the effect the opioid has,” she said. “Having the kit also offers an educational opportunity, highlights the serious risks these drugs present and increases overall naloxone distribution in the population.”
Canada’s overdose crisis has been driven by both pharmaceutical and illicit opioids, with regional differences. British Columbia and Alberta, for example, have seen fatal overdoses soar due largely to illicit drugs being contaminated with fentanyl. In Nova Scotia, meanwhile, problematic use is attributed to legally obtained but diverted prescription opioids.
Canada is the world’s second-largest per capita consumer of opioids, behind the United States. While final figures are not yet in, it’s believed that more than 4,000 Canadians died from opioid-related deaths in 2017 – at least a 40-per-cent increase from 2,861 in 2016.