The Process

For each drug recommended, the Director of the IMMP undertakes a feasibility study to examine and report on potential usage, sponsor company interest and/or concerns, methodology, special requirements and the resources required to undertake the monitoring. An important consideration is the demand being made on practitioners who must complete the questionnaires. Should this become too onerous, then compliance is likely to drop. The feasibility studies are then considered by an expert panel of four and a final recommendation is made to the Ministry of Health. The panel gives priority to monitoring those drugs where the following conditions apply:

* use is expected to be widespread and/or long term;

* safety issues have been raised from clinical trials or post-marketing experience and further evaluation is needed;

Table 27.1. Completed monitoring studies.

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