To healthcare and regulatory professionals, it seems obvious that safe use of drugs depends on products being taken in accordance with the directions on their labels. Individuals working in healthcare and its supporting industries usually have the knowledge to understand conventional drug labels, but a 2016 study published in the Canadian Journal of Hospital Pharmacy indicates 60% of the adult population lacks the health literacy skills to manage their health properly, and label comprehension is identified among the missing skills.
Even an informed consumer might find herself standing in the middle of a drugstore aisle with a package in each hand, trying to make sense of the label information so she can make an educated decision about a product before buying it. Through the sea of black and white text, she scans the label for familiar words, tries to decipher the technical terms, and picks out what she thinks are the critical pieces of information she needs in order to choose the right product. After purchasing the drug, she still must be able to follow the directions accurately in order to use it safely.
Drug product labels and packages contain important information, and it is critical that this information is clear, easy to understand, and presented in a reader-friendly manner for all consumers. Any misunderstanding of drug information can lead to serious consequences, including insufficient or excessive dosages, dangerous combinations, and negative side effects. The same 2016 study mentioned above indicates misuse of medicines accounts for one of the three most common types of adverse health-related events in Canada, and goes on to say that 37% of these adverse reactions are “highly preventable.”
In order to help consumers and health professionals receive and understand the information they need from drug labels, Health Canada introduced new Plain Language Labelling regulations. These regulations came into effect on June 13, 2015 for all prescription pharmaceutical drugs, biologics and radiopharmaceuticals; and, starting on June 13, 2017, all new applications for non-prescription drugs will be required to comply with the new regulations. Currently marketed products will need to be compliant at the production level by June 20, 2019 and at the retail level by June 30, 2021. At this time, natural health product (NHP) labels are not subject to the Plain Language Labelling regulations, but Health Canada has published a guide to best plain-language practices for NHP labels. In making drug labels and safety information clearer, the aim of the Plain Language Labelling regulations is to improve drug safety
One major change to the way label information must be presented on a drug product label is the requirement for a Drug Facts table on every label: Health Canada has prescribed the content and formatting for the Drug Facts table in hopes that regulating the way things like active ingredients and risk information are conveyed on drug labels will make it easier for consumers to identify and understand these key elements of a product.
Under the new regulations, applicants for DIN products will need to include a scale, full-colour, mock-up label with their Health Canada application, and this label will be reviewed by Health Canada for comprehension and legibility before a product license will be issued. The following are required for any new Drug Identification Number (DIN) application for a non-prescription product and for (Supplemental) New Drug Submissions (NDS) for prescription products:
-Submission of information in plain language to ensure labels are clear and understandable
-Assessment of drug product name to avoid any confusion with other marketed products
-Submission of to scale, full color 2-dimensional mock up product labels and packages
-Inclusion of contact information on labels to ensure users know how to report any problems
-Submission of information in easy-to-read format using various recommended font types and sizes, colors, bolding, etc.
-For non-prescription drugs, inclusion of a standardized Canadian Drug Fact Table on labels, to help locate important information, such as uses, warnings, directions, etc. The Canadian Drug Fact Table is similar to Canada’s Nutrition Facts table on foods.
With implementation of these regulations, Health Canada hopes that all consumers will be able to quickly locate and understand information about the drug products they consider, which will enable more educated choices and safer use of drugs.
These regulations impose significant new obligations on industry, and your existing drug product label may require revision. NHP Consulting Inc. has the expertise to guide you in complying with these regulations. Contact us for more information.