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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