The basic principles are as follows:
BASIC PRINCIPLES
The
basic principles are as follows:
·
The causality is judged only on the data present in the
case, in abstraction of all published data concerning the drug-reaction
association. Each case is judged on its own merits (intrinsic imputability) to
ensure maximal identification of possible new reactions. This also ensures
time-independent classification. Previous publications and labelling, which
vary over time, are only indicated, and are not an integral part of the
imputability.
·
The causality is assessed on each drug-reaction pair
presented by the patient at the time of the event, or that could be involved
(such as previously stopped medication that could result in unidentified
withdrawal symptoms).
This
method is thus very dependent on the Regional Centre/drug information centre
system, where there is early interaction with the reporter, so that
informa-tion can be accrued in real-time, rather than having to judge a case a posteriori on incomplete information,
as is usually the case in most paper-based spontaneous reporting systems where
the reporter has already made up his mind on causality when reporting, and
infor-mation is only present on the drug suspected by the reporter who often
has no formal pharmacological or ADR-assessment training.
The
method relies on a set of criteria that are, in fact, common to all causality
assessment methods, so that it is easy to reapply other causality meth-ods if
the proper information has been obtained. It is perforce very general in its
definition of criteria, and much attention has been devoted to refining
defini-tions of these criteria for specific reactions, and even for specific
drug-reaction associations (Habibi et al.,
1988; Fournier et al., 1989; Roujeau et al., 1989; Vigeral et al., 1989; Benichou, 1990; Benichou
and Solal-Celigny, 1991).
There
are six main criteria, three for chronology (time sequence) and three for
semiology (signs and symptoms). These are described below.
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