Warning Labels Now Required On Prescription Opioids in Canada

By Paul Gaita 05/08/18

The new regulations are part of legislation passed in 2014 to protect consumers from unsafe drugs.

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The Canadian government has passed regulations that will require a warning sticker and a patient handout for all prescription opioids purchased at a pharmacy.

CTV News has reported that the yellow labels, which will feature information about the adverse effects of opioid use, will begin appearing on prescriptions in October of 2018.

The new regulations are part of legislation passed in 2014 to protect consumers from unsafe drugs, though a Canadian pharmacists' group has expressed reservations about a one-size-fits-all approach to warning labels.

The regulations, which were announced on May 2, will require a yellow sticker on all prescription opioid containers that details the medication's possible potential for dependency and/or overdose.

Patients will also receive a handout from pharmacists that provides information about the signs of an opioid overdose, as well as warnings about sharing the medication or keeping it within reach of children.

Additionally, CTV noted that the regulations will also place requirements on pharmaceutical companies to develop plans to reduce the potential for harm in using opioid medications.

"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 Dr. Supriya Sharma, chief medical examiner for Health Canada, the country's department of health, who spoke at a media briefing in the capital city of Ottawa. "We want patients to have ongoing conversations with their healthcare providers and pharmacists about the risks and the benefits of prescription opioids. These stickers will help continue those conversations."

According to data from Health Canada, overdose deaths from prescription opioids rose sharply in 2017, claiming 2,923 lives in the first nine months of 2017 alone. That number is up more than 45% from statistics in 2016, when records were set by 2,861 deaths. Of the 2017 numbers, 92% were accidental, and 72% were caused by the synthetic opioid fentanyl.

The new regulations are part of the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, which paid tribute to the daughter of Conservative MP Terence Young, who died from a heart attack at the age of 15 after consuming a prescription drug, later deemed unsafe, for a stomach ailment.

The bill allows the government to conduct mandatory recalls on drugs that are considered dangerous for consumption, and impose strict penalties for such products.

However, the sticker/handout regulations are the first time the Canadian government has placed requirements on licenses to sell medication.

The regulations have drawn a reserved response from the Canadian Pharmacists Association, which has expressed "mixed feelings" about placing a homogenous label on all prescription opioids.

"One of the functions of pharmacies and how pharmacists practice is that we like to individualize our communications to patients," said Phil Emberley, the association's director of professional affairs. "We often tailor our communications to the unique needs of patients, depending on their demographics, on what particular disorder they're being treated for."

The association's concern hinged on whether the label and information sheet could be considered inappropriate for people who are taking opioid drugs like methadone or Suboxone to treat dependency issues.

"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," said Emberley to CTV.

Warning labels have been featured on immediate-release opioid painkillers in the United States since 2016, and the Food and Drug Administration (FDA) recently called for such labels to be included on cough or cold medication that contains codeine or hydrocodone to deem them unsafe for children under the age of 18.

A bill that would call for labels similar to those that will be implemented in Canada was announced by the New Jersey legislature in March 2018.

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites. 

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