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Health Canada to institute plain-language Rx labeling
June 14th, 2013
OTTAWA – Health Canada has launched the Plain Language Labeling Initiative, which aims to promote proper use of medications by making drug labels and safety information easier to read and understand.
Mininster of Health Leona Aglukkaq and Member of Parliament Terence Young announced the program Friday at Drugtown Pharmacy in Toronto.
"Every day millions of Canadians rely on drugs to maintain and improve their health. While medications offer significant benefits, they can also carry some risks," Aglukkaq stated. "I am pleased to announce that our government will be making plain language a requirement on drug packages in order to help prevent adverse drug reactions, medication errors and protect Canadian patients."
Under the Plain Language Labeling Initiative, comprehension of drug labels and drug packaging information would be improved through regulatory and guidance updates and development, as well as through outreach opportunities.
The drug safety proposal would advance key safeguards such as requiring labels to be in plain language; standardizing the format of over-the-counter drug labels (for example, a "Drug Facts" table) to help users locate important information; and requiring companies to include contact information on labels so consumer can report problems and adverse drug reactions.
In addition, manufacturers would be required to provide mockups of labels and packages for review and to provide evidence that drug names won't be confused with other authorized products.
Plans call for Health Canada to roll out changes in phases, starting with prescription drugs and then OTC medications. The ministry said that will be achieved by updating the regulations, providing guidance and education, and engaging with key stakeholders. The project is currently in development with the formal 75-day consultation on the regulatory proposal extending through the summer, followed by analysis of the comments.
"Drug labels are as important as traffic lights. They are as important as fire alarms. This is a generational change," Young commented. "What the minister is announcing today will save hundreds of lives a year."
Health Canada said today's drug product information can be confusing and, too often, people experience unnecessary harm as a result of drug labels, packaging or names that may be hard to understand or sound similar to other drugs. The ministry said that as many as one in nine emergency room visits are related to adverse drug events, and 68% of those are preventable.
"This new approach will make safety information more accessible to health care practitioners and all Canadians," Aglukkaq added. "This will benefit families and help reduce strain on our health care system across the country."