Thank you.
I'm glad you asked the question because I think I've left you with a mis-impression. There isn't a significant difference between the definitions as we put them versus Health Canada's. The wording might be slightly different, but the intent is very similar.
Let me just read to you the definition we use versus theirs, just to reassure you. The food and drug regulation definition of an adverse drug reaction is this: “A noxious or unintended response to a drug occurring at doses normally used or tested for the diagnosis, treatment or prevention of a disease or modification of an organic function.” That's Health Canada's definition.
Our definition is this: “Noxious, unintended response to drug when used at therapeutic, prophylactic or diagnostic doses. Significant morbidity/injury to patient, but did not directly cause death”. This is the involvement code.
We track involvements as well as death factors because it's important to have a three-dimensional picture of what happened to a person who died. So the involvement is a sublethal, if you like, or not lethal involvement of a drug, whereas if it's a death factor it is thought that the drug actually caused the death.
So our definitions are not significantly different, but we do have a different end point. Obviously Health Canada is interested in all drug reactions. We're interested in our population.