as an inherent characteristic of a spontaneous reporting system and not necessarily as a drawback.

Reports: Quality

Although an adequate number of reports are necessary to ensure a reliable reporting system, the Lareb Foundation attaches greater importance to the quality of those reports.

The quality of reports can also be seen to have risen each year. Quality is continuously assessed according to a number of criteria, one of which is the extent to which the report is documented. In an increasing number of cases, reports are accompanied by adequate clinical information, including the specialists' clinical notes to the patient's family practitioner. The fact that more complete information is now available may be attributed in part to the greater number of reports being made by hospital practitioners. The increase in the number of reports adjudged to be of a serious nature is shown in Table 24.2.

Although preparations which have been on the market for some time may occasionally reveal new adverse reactions (as in the case of vigabatrine, which had been available for over 10 years before a link with patients' restricted field of vision was made), the Lareb Foundation is particularly interested in new medicines. Table 24.3 shows the percentage of reports relating to preparations that have been on the market for less than five years.

Publications and Presentations

Having adopted a scientific and academic level as the basis for its working methods, the Lareb

Table 24.3. Total reports and percentage of reports on drugs marketed less than five years.



<5 years (%)

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