Plain Language Labelling Initiative is long overdue

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Many seniors have trouble with the labels on prescription drugs. The print is too small to read, and the words are often medical terms they don’t understand. For example, if a senior suffers from indigestion, the label doesn’t say ‘indigestion’. It says dyspepsia, but unless you’re a doctor or pharmacist, who knows what that means?

By the same token, if an elderly person has muscle pain, the term on the label is myalgia, and for joint pain it’s arthralgia. Such words are used because the labels are written by health care professionals like physicians or clinicians.

The potential for taking incorrect dosages, or the wrong medication, is real. Finally, something is being done.

Last June the federal government announced the Plain Language Labelling Initiative. The announcement was made by Leona Aglukkaq, Minister of Health, who was accompanied by two MPs. One of them was Terence Young of Oakville. In 2000 Young’s teenage daughter died of heart arrhythmia after an adverse reaction to a drug. The drug was later deemed to be unsafe and taken off the market.

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Problems with the labels of prescription drugs can be even worse for seniors, many of whom don’t have an advocate looking out for them. The ultimate goal of this initiative is to improve the safe use of drugs by making drug labels, as well as safety information, easier to read and understand.

The proposed regulations apply to drug manufacturers, and encompass both prescription and non-prescription drugs for human use. For the record, ‘plain language’ is described as communication that the public understands the first time they read it or hear it, which is often not the case with dyspepsia and myalgia.

Proposed amendments to the Food and Drug Regulations, which are part of Health Canada’s Plain Language Labelling Initiative, would:

  • standardize the format of non-prescription drug labels to help consumers locate important information
  • require companies to include contact information on labels so consumers can report problems and adverse drug reactions
  • require manufacturers to provide mock-ups of labels and packages for review as part of drug product applications, and
  • require manufacturers to provide evidence that drug names won’t be confused with other authorized products.

This has been a public process. After the announcement was made, the government kicked off a three-month period for public consultation on the issue. That period closed on September 6, 2013.

The Plain Language Initiative goes beyond simplifying words. It also includes fact tables that would be on the inner and outer labels of non-prescription drug products (in both English and French), as well as mock-ups of every label to be used for drug products. The label mock-ups would be required for new applications for prescription drug products, as well as for products used in doctors’ offices. The latter might include liquids that dilate the eyes in an eye examination; such products do not require a prescription and are not found in a drug store.

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These labels are important. One of the goals of the initiative is that outer labels on the carton of drug products would contain point-of-purchase decisions. So, if you are a senior with a heart condition, it will say right on the outer label to not take this drug, or to take no more than two tablets a day. This way the consumer knows to avoid the product, or how much of it to take.

As for inner labels within the packaging, they would be crystal clear about instructions. For example, the inner label might tell you to discontinue use of the item and consult a health care professional if you experience dizziness or a rash. Or it might tell you how long to take it if your symptoms persist.

The labels and packaging for these products are a serious problem for many seniors, especially those who self-medicate, and for people whose first language is not English or French. The labels contain vital information about the drug including recommended dosage, how often to take it, where to store it, and warnings or precautions. According to Health Canada, one in nine visits to emergency wards in hospitals is the result of medication, and 68 percent of those visits are preventable.

The intent of the Plain Language Labelling Initiative is to:

  • Improve and maintain the health of Canadians
  • Reduce health costs
  • Decrease the number of visits to hospital emergency rooms
  • Help identify risk (in terms of potential side effects or adverse events) from taking a drug by making the label more visible and easier to understand.

The government is still reviewing all comments received during the public consultation process, but let’s hope the Plain Language Initiative becomes law soon. This one is a no-brainer.