New prescription drug labelling rules in effect
YorkRegion.com
July 6, 2015
By Chris Traber
As of this month, Health Canada’s plain language labelling regulations begin to come into force.
The changes start with new requirements for manufacturers of prescription drugs to provide mock-ups of labels and packages for Health Canada review and to provide evidence that proposed brand names will not be confused with previously approved brand names.
The provisions also apply to drugs that are administered or obtained through a health professional.
Similar requirements for non-prescription drugs will come into effect in 2017
The goal of the labelling initiative is to make drug labels and packaging information easier to read and understand. Drug labels that are easy to read and understand help Canadians to use the right medications correctly and avoid potentially dangerous medication errors.
“Similar looking or sounding drug names can cause confusion and make it difficult for patients and health care providers to select the correct medication,” Health Minister Rona Ambrose said last week. “These new regulations will help to avoid potentially dangerous medication errors.”
Quick facts
- As many as one in nine emergency rooms visits are related to drug-adverse events and as many as 68 per cent of those are preventable.
- Unique drug names and labels that are easy to read and understand help Canadians to use the right medications correctly and avoid potentially dangerous medication errors.
- At present, some drug names cannot be searched because they are not included in either Health Canada’s notice of compliance database or the drug product database.
- The online drug product database will be updated to include drugs authorized but not currently marketed in Canada, so that these drug names will be searchable.
- In 2014, Health Canada provided updated guidance to drug sponsors on how to choose and test drug names to reduce confusion. Look Alike - Sound Alike provisions require manufacturers to provide evidence that drug names will not be confused with other authorized products.
- In 2014, the Government of Canada introduced Vanessa’s Law, which delivered important new drug safety measures for Canadians and also brought in a new era of transparency around patient safety information.
