OTTAWA, ONTARIO -- (Marketwired) -- 06/14/13 -- The Honourable Leona Aglukkaq, Minister of Health, today announced the launch of the Plain Language Labelling Initiative, which aims to improve the safe use of drugs by making drug labels and safety information easier to read and understand. Minister Aglukkaq was accompanied by Terence Young, Member of Parliament for Oakville.
"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," said Minister Aglukkaq. "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."
To work properly and reduce the chance of harm, drugs should be taken according to the information provided on the label or package. Yet, today's drug product information can be confusing to follow. Too often, people experience unnecessary harms as a result of drug labels, packaging or names that may be hard to understand or they sound similar to other drugs. As many as 1 in 9 emergency rooms visits are related to drug adverse events, and as many as 68% of those are preventable.
"Drug labels are as important as traffic lights. They are as important as fire alarms. This is a generational change. What the Minister is announcing today will save hundreds of lives a year," said MP Young.
"This new approach will make safety information more accessible to health care practitioners and all Canadians," said Aglukkaq. "This will benefit families, and help reduce strain on our healthcare system across the country."
The goal of this initiative is to reduce preventable harm. Health Canada will begin by targeting improvements to the regulations, such as requiring evidence that drug names will not be confusing, providing guidance and education, and engaging with key stakeholders along the way.
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Plain Language Labelling
Drug product labels and packages contain critical information about the safe and effective use of health products and are important tools to help Canadians make informed decisions about their health. To work properly and reduce the chance of harm, drugs should be taken according to the information provided on the label or package.
Yet, drug product information can be confusing to follow. Improvements to drug product labelling and packaging are needed so health professionals, patients and consumers can more easily find out how to use the drug, how often to take it, and when it should not be taken.
What is plain language?
Plain language is a clear writing style that is designed to be easy to read and understand by the intended audience.
The Plain Language Labelling Initiative
The Plain Language Labelling Initiative aims to improve the safe use of drugs by making drug labels and packaging information easier to read and understand. This will be achieved through regulatory and guidance updates and development, as well as through outreach opportunities.
The proposal would advance key safeguards, such as:
-- requiring labels to be in plain language-- standardizing the format of non-prescription drug labels (such as a "Drug Facts" table) to help users locate important information-- requiring that companies include contact information on labels so that users can report problems and adverse drug reactions-- requirements for manufacturers to provide mock-ups of labels and packages for review, and-- requirements for manufacturers to provide evidence that drug names will not be confused with other authorized products
Health Canada plans to roll-out these changes in phases beginning with prescription and then non-prescription drugs. This will be accomplished by updating the regulations, providing guidance and education, and engaging with key stakeholders along the way. This multi-phased 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 prior to publication in the Canada Gazette, Part II.
Office of the Honourable Leona Aglukkaq
Federal Minister of Health