In December 2011, the US Food and Drug Administration (FDA)
reported that at least one serious injury occurred when a topical
wart remover, Durasal (salicylic acid 26%), was dispensed to a
patient following eye surgery instead of a topical corticosteroid,
Durezol. Prior to this incident, the FDA issued a notice that
several other cases of confusion between Durezol and Durasal had
Instances of drug confusion due to look-alike or sound-alike
drug names continue to be reported in Canada as well. For example,
in November 2011, Health Canada released a notice regarding
potential confusion between the anticoagulant, Pradax, and the
antiplatelet drug, Plavix. In 2011 alone, there were five reported
Canadian cases involving mix-ups between the two drugs, with at
least one case of confusion resulting in patient harm.
In addition to patient harm arising from medication errors due
to similar drug names, cases of drug name confusion can have
significant implications for drug manufacturers, such as the
suspension of drug sales by Health Canada, delays in having drug
submissions approved, and potentially significant costs associated
with renaming drug products (e.g., re-labelling, repackaging,
In order to mitigate the potential problems due to drug name
confusion, including medication errors, Health Canada provides
guidance on naming practices. For example:
Proprietary drug names should consist of only one word and
should avoid qualifications by letters or numbers;
Brand names and generic names for drug products that contain
different medicinal ingredients should be easily distinguishable;
Care should be taken when adding a prefix or suffix to modify
the name of another drug in order to indicate a product line
extension. Sponsors should be prepared to furnish Health Canada
with a rationale as to why it is unlikely that the proposed drug
name will give rise to safety or efficacy concerns.
Drug manufacturers should take note of Health Canada's
suggestions in order to avoid both pre- and post-market regulatory
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financičre Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
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