The French Imputability Method

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Chapter: Pharmacovigilance: Spontaneous Reporting - France

This method was first devised in 1978 (Dangoumau, Evreux and Jouglard, 1978), revised in 1985 (when it was published simultaneously in French and in English) (Begaud et al., 1985).


THE FRENCH IMPUTABILITY METHOD

This method was first devised in 1978 (Dangoumau, Evreux and Jouglard, 1978), revised in 1985 (when it was published simultaneously in French and in English) (Begaud et al., 1985). It is the only imputabil-ity (causality assessment) method to have legal status. It is probably one of the most widely used, if not the most widely used, imputability method, having been applied to more than 100 000 reports, and yet it remains widely misunderstood.

The method was derived when the regional network was developing, to ensure that all the Centres worked and assessed reports in reasonably the same way. It has a few basic principles, designed to ensure the highest possible sensitivity when used routinely on incoming reports. It is because of this that the term ‘causality assessment’ may not really be applicable in that it is not causation per se that is assessed, but the possibility of involvement, a subtle distinction.

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