Regulatory Focus™ > News Articles > Health Canada Calls for New Drug Regulations Emphasizing Labeling Clarity

Health Canada Calls for New Drug Regulations Emphasizing Labeling Clarity

Posted 18 June 2013 | By Alexander Gaffney, RAC 

Drug labels can be poorly written, confusing or otherwise dangerous - and that's assuming you're a proficient reader literate in health care terminology. In response to the difficulties and safety risks assumed by consumers confronted with unclear prescription drug labeling, Health Canada has announced it will launch a "Plain Language Labeling Initiative" to require drug labeling to be clear to consumers.

Background

Public health officials around the globe have long flagged poor labeling practices as a prominent cause of adverse events and injury. A 2006 report by the US Institute of Medicine (IOM), a government think-tank of sorts focused on healthcare, identified eight major sources of medication errors related to labeling:

  • The names of drug products can sound or look the same, causing consumers to consume the incorrect product.
  • The same drug may have several formulations, which means consumers might take the wrong dose or be prescribed the incorrect product.
  • Abbreviations on the product labeling might be used to represent several similar concepts.
  • Symbols, derivatives and abbreviations could be confused.
  • Labels are difficult to read because they are cluttered, use small fonts and illegible text.
  • Company logos are too prominent and distract from more important information.
  • Warnings and reminders are not properly or adequately emphasized.
  • Terminology is not adequately standardized.

IOM's report found that thousands of deaths are caused each year by medication errors-as many as 33% of all medication errors and 30% of all fatalities. Data cited by Canadian officials said at least one in nine emergency room visits were estimated to be related to drug adverse events, of which almost 70% were thought to be preventable.

Clear, Canadian Labeling

US regulators have taken a number of steps in recent years to mitigate these concerns for both pharmaceutical products and medical devices, and now Canadian regulators are doing the same for pharmaceuticals, launching their "Plain Language Initiative."

The initiative responds directly to some of the points raised by the IOM report, and would require - if implemented - labels to be written in an easy-to-read and clear manner, use a standardized format (i.e. a "Drug Facts" table) for non-prescription drug labels, require information to facilitate adverse event reporting and quality reporting,  and evidence that drug names would not be confused with other products.

The proposal also calls for manufacturers to submit a mock-up of the drug labeling and packages to regulators for review, though it is not yet clear whether this would be a premarket or postmarket requirement. Regulators said they planned to implement all changes first for prescription drug products, later expanding the initiative to include non-prescription (i.e. over-the-counter) medications as well.

"Drug labels are as important as traffic lights," said Terence Young, a member of the Canadian parliament. "They are as important as fire alarms. This is a generational change. What the Minister is announcing today will save hundreds of lives a year."

Industry, meanwhile, has offered general support for the measure. BIOTECanda, a biotechnology industry group, said it "looks forward to continuing to offer its perspectives to the Minister and her department to ensure biologic medicines continue to bring improved health outcomes to Canadian patients."

"Ensuring patients have timely and informed access to medicines is an essential part of a safe and efficacious health care treatment. In this context, BIOTECanada supports the Plain Language Labeling initiative as it moves forward into the next phase of consultation."

The proposal is currently open to 75 days of public comment, leaving final publication to occur in late 2013 or early 2014.


The Plain Language Labeling Initiative


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