For the first time, Ottawa has used the regulatory power of legislation to place conditions on licences to sell medications, and has recently issued a requirement that all manufacturers of high risk, powerful opioid painkillers produce and implement a risk management plan that includes monitoring the adverse effects of drugs once they have been licensed to sell in the market.
Health Canada has announced that come this October, all prescription opioids sold in Canada will be required to wear a warning sticker about their particular adverse effects and will be accompanied by pharmacist-distributed fact-sheets that will contain further information about the potent narcotics.
This is the first time regulations have been put in place for warning stickers and patient handouts, and Health Canada’s chief medical adviser, Dr. Supriya Sharma, has announced that the yellow stickers will contain information such as risks pertaining to dependency, addiction, and overdose. The handouts will be comprised of a single page information sheet that details signs of opioid overdose and side-effects, warnings to refrain from sharing prescriptions, and advice regarding the safe storage of medication.
The new federal regulations are also pushing for pharmaceutical companies to create and implement risk-managements plans so that harmful side-effects of prescription drugs are minimized.
“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. These stickers and handouts will help continue those conversations.” Health Canada’s Chief Medical Adviser, Dr. Supriya Sharma
Sharma hopes that the stickers will provide a visual warning, or “red flag,” for those using prescribed high risk medications, and the handouts will provide extra information to help users take their painkillers safely.
“And the most important thing about that is this information will be consistent,” she says, “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.”
These new warning labels and accompanying information are part of Vanessa’s Law, named after Canadian teenager Vanessa Young, who died in 2000 after ingesting prescription medication. Passed in 2014, the law is designed to protect consumers from the unsafe use of medications and to reduce harmful drug reactions.
As Sharma states, all prescription opioids were approved before risk management plans were implemented, so the new regulations will force manufacturers to “put these plans in place and … allows us to have consistency in our approach to the way these products are monitored once they’re on the market.”
The regulation plans will also include training sessions for doctors and other health care professionals so that they are also aware of the risks for patients using these types of drugs.
“If we find that somebody isn’t complying,” says Sharma, “Our first step is to try to bring them into compliance, to work with the company to make sure that they’re doing that.
See here for more information about the State of Opioid Use in Canada.