New Regulatory Tools in the Fight Against the Opioid Crisis

Progress from Canada

Megan Bettle
Director, Regulatory Reform
of Drugs and Devices
Health Canada


ver the past several years, opioid overdose deaths have increased substantially in Canada. Data released in June 2018 showed that there had been almost 4000 opioid-related deaths in Canada in 2017, rising from around 3000 in 2016. The highest rates on a population basis are in western regions such as British Columbia, Alberta and Yukon, but the new data show clearly that the opioid crisis is a broad national problem. Similar increases have also been seen in the United States.

The North American opioid crisis is complex. What was initially viewed as an issue linked primarily to the problematic misuse of prescription medicines and thought to have roots in over-prescribing, has been made worse by the unpredictable and potent drug content of illegal opioids. Fentanyl and similar powerful synthetic opioids are inexpensive to make and easy to ship in small volumes, and have been identified in a high proportion of the illegal drug supply.

The Canadian opioid crisis is being treated as a public health emergency, and, given its breadth and urgency, a broad range of creative actions are being pursued in the areas of prevention, treatment, harm reduction, and enforcement. Widespread availability of naloxone, a drug that temporarily reverses an opioid overdose and has been made available without a prescription, and the creation of more supervised consumption sites and overdose prevention sites have created safer spaces for self-administered drug use, where emergency medical treatment and referrals to longer-term treatment solutions are also being made available. Some facilities have offered drug checking services, permitting persons who use drugs to make a more informed choice about what and how much they consume.

A new regulatory pathway has been created to allow public health officials to import drug treatments that have been authorized in the United States, European Union and Switzerland. In support of having a variety of treatment options available, these Importation of Drugs for an Urgent Public Health Need Regulations have been used primarily to bring in therapies for the treatment of opioid dependence and prevention of relapse, which are not yet available in Canada, including diamorphine (pharmaceutical grade l heroin). The pathway is a temporary measure, granting access to these listed products for one year, but access is renewable if the public health need persists.

With respect to the prescription of opioids, there is no question that appropriate use of opioids is essential in certain therapeutic areas. However, according to international statistics, Canadians are the second highest users of prescription opioids in the world. While opioids generally fall under the Controlled Drugs and Substances Act, opioids that are used as medical products also fall under the Food and Drugs Act and Regulations, and as part of prevention efforts, the drug regulator, Health Canada, is taking steps to mitigate risks associated with the use of legitimate prescription opioid products.

In May 2018, regulations were published that will make it mandatory for certain high-risk prescription opioids to be dispensed with a warning sticker that states that opioids can cause dependence, addiction, and overdose. Additionally, a patient handout will be required, informing patients of signs and symptoms of overdose, other serious side effects, and including instructions about safe storage of opioid products. These requirements will come into force in October 2018. The regulations also give the Minister the ability to impose terms and conditions on opioid authorizations, a measure that came into force immediately. This authority will be used to require opioid manufacturers to develop mandatory risk management plans that could include improvements to product labelling or other measures to make the use of these essential medical products safer. In placing terms and conditions requiring risk management plans on the authorization of these products, the Minister of Health is using, for the first time, the type of drug safety authorities that were created in updates to the Food and Drugs Act in 2014 known as the Protecting Canadians from Unsafe Drugs Act, or “Vanessa’s Law.” These new authorities, some of which require additional regulatory changes to come into force, will provide additional tools that will support managing other prescription drug-related risks.

Most recently, the government has announced its intent to restrict the marketing and advertising of opioids to prescribers (direct-to-consumer advertising for all prescription and controlled drugs is already prohibited in Canada).

Clearly, solving the opioid crisis will neither be simple nor fast. However, this issue has seen unprecedented flexibility, cooperation, and commitment across drug control, public health, medicines regulation, and affected individuals, actions that we hope will start shifting the direction of the mortality trends.