Public Accounts committee  As I just said, all of our actions show our commitment…

Public Accounts committee  I think all of our actions indicate that this is what we're currently doing.

Public Accounts committee  We need to take into account an important factor. We must not forget that we always deal with the most urgent things first. Health Canada's priority remains the safety of Canadians. We will grant priority to the various issues related to drugs. Some of them may take longer becaus

Public Accounts committee  Actually, what's important is dealt with as a priority. Of course, we always want to do things as quickly as possible. However, when there is a significant risk for Canadians, we act as quickly as we can.

Public Accounts committee  I think that, in the past few years, the department has made considerable progress with respect to its ability to tackle the drug safety issues that arise. The department has increased its ability to respond; it has improved its response time; it has increased the number of issue

Health committee  When a drug is used off-label, it's because a physician makes a decision in a specific patient when this drug would be, on a population level, contraindicated. Maybe because that patient is allergic to other available therapies or has not tolerated the other available therapies,

Health committee  The concept of independence comes from the fact that it is a different group doing the follow-up on the medications after they are put on the market. Witnesses have told you that the MHPD was not well known and that people in the directorate should be told to look at medications

Health committee  Yes. The main responsibility is under the professional associations, which are provincially based.

Health committee  It's difficult to assess, because there is no evidence. Basically, the challenge around off-label use is that the drug use is not supported by the same thorough evaluation. You are right, yes, that there is a risk of adverse events for off-label use, as there is for approved use.

Health committee  Yes, they are. When there is a report for an adverse drug reaction, that report is not related to whether the drug was used within the approved indication or off-label. It's also interesting that internationally and also in Canada we are moving to a life cycle approach. Basical

Health committee  Thank you for your question. Off-label use of a therapeutic product is basically when a product is used outside of the approved product labelling. It might be a different dosage or different route of administration, or outside of the indication for which the drug was initially a

Health committee  If we take the post-market adverse event report for pharmaceuticals, from any source, whether they come from the manufacturers or consumers or health care professionals, they will all end up in the same area, which is the Canada Vigilance database. This is where the Canadian repo

Health committee  Yes, there are numerous tools used to report back. This is one of the tools we use to identify emerging safety signals. So in that sense, if we take action, that's some kind of retroaction to the Canadian public and to the reporters. It's indirect, but that's one source of retroa

Health committee  The Canadian Adverse Reaction Newsletter is published every three months, so it's quarterly.

Health committee  Maybe I can add some information about its distribution. That newsletter is distributed to 67,000 physicians in conjunction with the Canadian Medical Association Journal. It's also printed and distributed to an additional 26,000 health care professionals, mostly pharmacists. It