The product monograph is a document that provides information on the indications, the use, contraindications, warnings, precautions, and side effects. It has a part two, which has information for patients, and it has a central part, which has evidence that supports the market authorization.
As I mentioned in my opening remarks, it's a living document in the sense that as we learn more, as there is more exposure to mefloquine in broader populations, the importance of side effects becomes better understood. The document was upgraded and certain things in it were changed from the original.
A history of psychiatric or neurological problems, which was a warning, was moved to becoming a contraindication. The fact that suicidal ideation being seen was also included. The fact that these side effects could persist after the drug was stopped was added.
If you look at the history of when that was done in the U.S. and when it was done in Canada, there was a very similar progression of the product monograph.
We don't then talk to prescribers, other than to alert them that the product monograph has changed, or as I pointed out in my opening remarks, in 2005 we put out a risk communication with the manufacturers to ensure that health care providers were aware that this was changing. But the responsibility is also on the prescribers to see when things are changing, to invest in the discussion around the safety of medication, and to adjust their prescribing patterns accordingly.