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From Diplopia to Double Vision: Health Canada’s Plain Language Labeling Project Is a Sight for Sore Eyes

Reading Time 4 minute read

Life Sciences Bulletin

According to Health Canada, over-crowded and confusing drug labels, unclear instructions, and similarities between packages and names are the primary cause of medication errors in Canada. Due to the increasing regulatory requirements imposed upon drug labels, the complexity of the information provided on these product labels has become burdensome to read and too dense to navigate.  On June, 22, 2013, Health Canada initiated The Plain Language Labeling Project, which specifically aims to improve the clarity, readability, and ease of use of drug information intended for consumers.

Information about a drug is communicated by drug manufacturers to patients using both the product label and a product monograph. Health Canada's proposal will focus on the presentation of information on the labels and in the product monograph for both prescription and non-prescription drugs. At the moment, technical information directed to physicians and pharmacists is printed alongside information that is directed to consumers. 

To improve clarity, manufacturers will be asked to avoid clinical terminology used by professionals such as physicians and pharmacists. Health Canada has also proposed a table of common technical terms and their plain language equivalents. Among the more common terms, arthralgia would be changed to joint pain, dyspepsia to indigestion, epistaxis to nose bleed and myalgia to muscle pain.  To add value, more precise information such as expressing the frequency of side effects in numbers (i.e. affects 1 user in 10) instead of vague terms such as "very common side effects" is expected to provide more accurate information to patients. Moreover, in a consultation with stakeholders, the title "product monograph" may be simplified since Health Canada is reviewing whether it sufficiently and explicitly conveys to consumers that the document contains valuable information.

Not only has Health Canada decided to tackle the content of labels and product monographs, but they are also considering changing the format.  Product monographs, more often than not, are extremely long and drafted in black and white, 10 point font, with very minimal heading and bolding added to assist in navigating the text.  Health Canada is proposing potentially adding color, bolding, headings and increasing font size, bullets points and graphics to help inform patients. Health Canada views these amendments as a "happy medium" in making the product monograph less dense than the current format but more informative than the pharmacy provided fact sheets.

The proposal goes beyond just requiring labels to be in plain language but includes standardizing the format of non-prescription drug labels to help users locate important information. Health Canada has proposed drug fact tables that would include a list of "adequate directions for use," such as indications or uses, recommended single and daily dose, route of administration, storage conditions, warnings and precautions; a list of the medicinal (or active) ingredients and non-medicinal (or inactive) ingredients in both English and French. The objective of these amendments is to group information in a manner that is distinct from other information to help users locate and read critical information about a product.

Finally, for drug names, manufacturers may be required to submit an assessment that the brand name of their drug would not be mistaken for the brand, common or proper name of a different authorized drug. Health Canada has proposed guidance and tools for how to conduct such an assessment (see Draft Revised Guidance of Drug Names for Look alike Sound Alike Attributes). Companies are further required to ensure that their contact information is printed on every label so that users can report problems and adverse drug reactions. As such, manufacturers will be required to provide mock-ups of labels and packages for review and compliance with these new requirements by Health Canada.

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. Better labelling is expected to lead an average cost savings to the health care sector of approximately 1.9 million dollars annually resulting from the expected reduction in adverse events, dispension errors and improved over the counter product selection and use.


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