Minister Ambrose Announces Plain Language Labelling Regulations Coming Into Force

Easier-to-Read Labels and Unique Drug Names Improve Patient Safety

OTTAWA, June 24, 2015 /CNW/ - As of this month, Health Canada's Plain Language Labelling Regulations begin to come into force – starting with new requirements for manufacturers of prescription drugs to provide mock-ups of labels and packages for Health Canada review; and 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

Drug labels that are easy to read and understand help Canadians to use the right medications correctly and avoid potentially dangerous medication errors. The goal of the Plain Language Labelling initiative is to make drug labels and packaging information easier to read and understand. 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 the Plain Language Labelling Initiative.

Quick Facts

• As many as 1 in 9 emergency rooms visits are related to drug adverse events, and as many as 68% of those are preventable.
• Unique drug names and labels that are easy to read and understand help Canadians to use the right medications correctly and avoid potentially dangerous medication errors.
• At present, some drug names cannot be searched because they are not included in either Health Canada's Notice of Compliance (NOC) database or the Drug Product Database (DPD).
• The DPD online will be updated to include drugs authorized but not currently marketed in Canada, so that these drug names will be searchable.
• In 2014, Health Canada provided updated guidance to drug sponsors on how to choose and test drug names to reduce confusion.  Look Alike – Sound Alike provisions require manufacturers to provide evidence that drug names will not be confused with other authorized products.
• In 2014, the Government of Canada introduced Vanessa's Law, which delivered important new drug safety measures for Canadians and also brought in a new era of transparency around patient safety information.

Quotes

"Similar looking or sounding drug names can cause confusion and make it difficult for patients and healthcare providers to select the correct medication. These new regulations will help to avoid potentially dangerous medication errors. Our Government is delivering on its Speech from the Throne commitments by continuing to make patient safety a top priority."
Rona Ambrose
Minister of Health

"We have already made great strides with Vanessa's Law to improve patient safety and the Plain Language Labelling Regulations is a further measure our Government is taking to help ensure Canadians make well-informed choices concerning their health and that of their families."
Rona Ambrose
Minister of Health

"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. When two drug names sound alike, or look alike in writing, a patient can end up taking the wrong drug, which can be deadly. Requiring clear drug names will build on the actions our Government has already taken by passing Vanessa's Law, and will help to save lives."
Terence Young
Member of Parliament for Oakville

Associated Links

July 2014 Plain Language Labelling Announcement

June 2013 Plain Language Labelling Announcement

Health Canada's Roadmap for Regulatory Modernization

Health Canada's Regulatory Transparency and Openness Initiative

SOURCE Health Canada

Michael Bolkenius, Office of the Honourable Rona Ambrose, Federal Minister of Health, [phone]; Health Canada, Media Relations, [phone]; Public Inquiries: [phone], 1-866 225-0709; Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media