Discussion Category

Conditional release in Canada is feasible but would not be easy due to the requirement for all being evaluated to be listed in all formularies during the conditional release phase. The implementation would require new legislation (probably); a change in philosophy away from a system concentrated on premarketing evaluation to one with a greater focus […]

An alternative source of information is the patient, a suggestion that received criticism, when included in one of the proposals 20 years ago , on the grounds that its value would ‘be outweighed by the potential harm to the doctor-patient relationship’ . Attitudes of patients toward physicians and the health care system have changed during […]

To evaluate effectiveness, questions would have to be developed that are appropriate to the particular drug or class of drugs. They should probe effectiveness in detail and cover as many aspects as possible such as comorbidities, quality of life and compliance to treatment. The physician’s opinion about whether the drug was effective or not is […]

Experience in Saskatchewan and elsewhere has shown that the International Classification of Diseases coding is inadequate for the comprehensive recording of signs and symptoms that are essential for identifying potential adverse drug reactions such as cough associated with angiotensin-converting enzyme inhibitors. Thus, either a new coding system has to be developed by the monitoring organization, […]

Ideally, all appropriate new active substances to be used on an outpatient basis would be conditionally released, which, as stated previously, is estimated to be about 15 per year. This number still demands a substantial financial commitment to provide sufficient staff and resources to perform a proper follow-up process, although pharmaceutical companies are required to […]

The Health Protection Branch (HPB) of Health Canada could be responsible for ensuring that adequate data on effectiveness and safety were collected and appropriately evaluated, but preferably this would be done by an independent organization associated with but not directed by the HPB. However, because an independent organization would probably need legislative revision to change […]

How much would this cost? There are currently 30 to 35 new active substances approved each year , but several of these are only used in the hospital setting or in special institutions, such as cancer treatment centres, and schemes to evaluate the effectiveness and safety of these drugs should already be in place. Consequently, […]