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 insufficient. The evaluation of how well a product works in everyday medical practice goes beyond whether the drug cured the condition or alleviated symptoms. However, the need to obtain as much information as possible about effectiveness would have to be balanced against keeping the questionnaire as short as possible to improve the likelihood of receiving a response.
The appropriate professional to report effectiveness and safety is the prescribing physician. To ensure that physicians cooperate with conditional release, their response would have to be paid for or mandated by legislation, or both. Even then, the opportunities for ‘doctor shopping’ in Canada Healthcare and the lack of information passed between various physicians treating the same patient may limit the data that an individual physician could supply about a patient, and pertinent details for the evaluation of effectiveness and safety may be omitted. In such situations, there should be careful aggregation of information from the multiple physicians. This becomes increasingly feasible as more physicians move to computerized patient records.