Health Canada to enforce plain language labeling rules

Health Canada’s plain language labeling rules will begin to come into force as early as this month. The first step in the process is for Health Canada to review mock-ups of labels and packages of prescription drugs provided by manufacturers.

The manufacturers will also have to provide evidence that proposed brand names will not be confused with previously approved brand names.

The provisions also apply to drugs that are administered or obtained through a health professional. Similar requirements for non-prescription drugs will come into effect in 2017.

The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were published in July 2014, and are part of a wider plain language labeling initiative.

The primary goal of the initiative is to make drug labels and packaging information easier to read and understand. This will help Canadians to use the right medications correctly and avoid potentially dangerous errors.

“Similar looking or sounding drug names can cause confusion and make it difficult for patients and healthcare providers to select the correct medication,” said Minister of Health Rona Ambrose.

“Canadians deserve to have clear and understandable information about the drugs they are prescribed, and that has to start right on the prescription and labels,” added Oakville MP Terence Young. “When two drug names sound alike, or look alike in writing, a patient can end up taking the wrong drug, which can be deadly”

This new initiative will go a long way in avoiding drug adverse events.  As many as one in nine emergency rooms visits are related to drug adverse events, and as many as 68% of those are preventable.


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