Health Canada is in the midst of a “modernization makeover.” The Agency is undertaking a multi-year, comprehensive review of its regulatory frameworks for health products and food. Among other things, modernization efforts are aimed at developing a more efficient, sustainable, transparent and flexible system that applies common principles across product lines.
Increased transparency and improved patient compliance are key goals, and we have seen some recent changes targeted specifically at these initiatives.
Most recently, on September 15, 2015, Health Canada announced consultation on a Draft Guidance document relating to the labelling of products containing acetaminophen. Health Canada is proposing plainer language and stricter warnings regarding misuse, based on the Agency’s review into the uses of acetaminophen.
Acetaminophen is available as a single-ingredient product and in combination with other ingredients in, for example, cold and cough medications and narcotic pain relievers. According to Health Canada, more than 475 different acetaminophen products have received market authorization in Canada, the majority being non-prescription. The current maximum recommended daily dose of acetaminophen is 4g in Canada (similar to the recommended dose in many other countries) and the maximum recommended duration of use is three to five days, depending on the indication.
Although acetaminophen is generally considered to be a safe medicine when taken as directed, Health Canada found evidence suggesting that the risk of liver injury with acetaminophen use may be increased in certain situations − for example, when the individual suffers from alcoholism, malnutrition or liver disease.
Health Canada has undertaken a number of safety reviews and implemented labelling standards (including warnings) to reduce the risk of liver injury associated with acetaminophen. These activities have been in line with the work of regulators in other countries. Health Canada’s most recent initiative involved a more in-depth scientific review to make recommendations for further reducing the risk of liver injury to Canadians using acetaminophen. A summary of Health Canada’s report was released earlier this year.
Health Canada’s recently-proposed changes to acetaminophen labels include:
- Requiring a prominent statement declaring the presence of acetaminophen to make it easier for consumers to identify products containing it
- Requiring the use of plain language
- Creating a Product Facts Table with safety information in an easy-to-read format (including stronger warnings and alcohol-related directions) and
- Requiring clearer and more obvious dosing instructions to prevent the risk of accidental overdoses (including daily doses, intervals and duration of use).
The idea behind these proposed labelling changes is to provide consumers with straightforward, easier to understand dosage, administration and warning information to help prevent misuse.
Now is the time to make comments
Stakeholders have until November 29, 2015 to make comments on the draft acetaminophen labelling standard. Following review of comments received, Health Canada will publish the final labelling standard and an implementation plan.
These recent proposed labelling changes follow closely on the Plain Language Labelling amendments to the Food and Drug Regulations, which came into force in June 2015. These impose new obligations on manufacturers to ensure labels are clear, understandable and written in plain language and contain standard drug information tables and contact information for consumers with problems or questions. In addition, these amendments require manufacturers to submit label mock-ups to Health Canada for pre-market review and to undertake and submit look-alike sound-alike assessments of product names.