Sunday, November 25, 2007

Core Safety Information

When reporting the adverse events in core safety information (CSI),
sometimes, the corporate faces a dilemma. On the one hand, due to the legal consideration, they may want to include all adverse events as many as possible so that nobody can say that certain side reactions are not warned if some bad things happen, on the other hand, over reporting/over inclusion are not suggested by CIOMS Working Group.

Routine inclusion of an extensive, indiscriminate list of adverse events is ill-advised for several reasons:

information included uncritically makes it more difficult to distinguish disease-related events or events that may be related to concomitant therapy from those that are due to the subject drug.

Dilution: over-inclusion can obscure or devalue the truly significant adverse experiences, thereby diluting the focus on important safety-information.

Mistake: by including "unsubstantiated" information, the physician may be led to do the "wrong" thing. For example, inclusion of an incompletely studies or ill-documented weak signal of a possible birth-defect could lead to unjustified abortion; overwarning for an important medical product could result in a change to a different medication not carrying the same type of warning, yet less safe or less effective.

Diversion: the inclusion of ill-substantiated information may discourage further spontaneous reporting of problems, which might have confirmed or clarified the extent and nature of the adverse event.

Clutter: ease of reading and understanding is critical; the fewer words and the less extraneous information the better.

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