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Health committee  In fact, the best source of information is the person to whom the patient speaks. If a patient experiences a reaction, which he does not necessarily associate with his medication, and he tells his pharmacist, because he sees him on a regular basis, then the pharmacist would be the best source.

February 14th, 2008Committee meeting

Manon Lambert

Health committee  We already know the frequency with which reactions to most drugs are experienced. ADRs are detected at the pre-marketing stage precisely because they occur frequently. We therefore have a good idea of the frequency at which they occur. Mandatory post-marketing reporting would not simply reproduce information available at the pre-marketing stage.

February 14th, 2008Committee meeting

Manon Lambert

Health committee  As health care professionals, we always have to strike a balance between risks and benefits. Earlier, this lady said she had received cancer treatment. Usually, when a patient is suffering from a potentially deadly cancer, the health care professionals treating that patient will accept a higher level of adverse reactions and potential risks of mortality, because this is a somewhat desperate situation.

February 14th, 2008Committee meeting

Manon Lambert

Health committee  As a general rule, the pre-market review reveals the most common ADRs. Normally, between 2,000 and 3,000 patients will have tried the drug before it is marketed, although, of course, it all depends on the type of drug. In light of the number of patients who participate in trials, it is clear that we endeavour to strike a balance between getting the drug onto the market and having adequate knowledge of it.

February 14th, 2008Committee meeting

Manon Lambert

Health committee  One of my colleagues pointed out earlier that an integrated system is required. This is because even if we have the best databases available, offering both quality and quantity, we cannot always avoid ADRs if the information does not get—in a timely fashion—to the professional who has a patient standing in front of him.

February 14th, 2008Committee meeting

Manon Lambert