Process

The task of the working group was to develop proposals for standard principles and guidelines addressing the what, when, how and where of CSI. The summary of product characteristics (SPC), the official document of the European Union, was used as a model to try to answer the following general questions:

* What evidence is needed, and how should it be used, to influence a decision on whether an adverse experience should be included, excluded or removed from the CSI?

* At what point in the accumulation and interpretation of information is the threshold crossed for inclusion or change in the CSI?

* What "good safety-labelling practices'' can be specified concerning the clinical relevance of information, how it is expressed and the appropriateness of "class-labelling"?

* What should the sections of the CSI be called, how should they be defined and where should specific information be located?

At the beginning of the process the group hoped to develop specific threshold criteria, or an algorithm, for determining when information should be included in the CSI. However, this was not possible and it became necessary to rely on collective judgement to reach consensus. A series of case scenarios was created from real-life examples for which the decision to amend a data sheet was equivocal. Each member of the group was asked individually to make decisions on the available data. In addition, each person was asked to list the factors taken into consideration when reaching their conclusions. A total of 39 factors were identified and each member of the working group was asked to rank the factors in order of importance. As expected, there was a considerable divergence of opinion but overall the mostly highly ranked criterion for a positive decision was the presence of positive rechallenge information. The reader is referred to the original report for the remaining factors and their respective rankings.

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