Consequence Analysis

As far as possible, the likely consequences of a response to a safety concern should be considered before the action is undertaken. Input should be sought from experts in communication science, patient groups, practising health professionals and others when trying to predict consequences. This knowledge should guide choices between the options for action available. For example, a consequence analysis should be planned before a warning about a drug is given out or the drug is taken off the market. This analysis should be in two parts: an early investigation designed to ensure that the expected effect was achieved, so that a correction or reinforcement can be applied as necessary, and a later evaluation to ensure that a positive response is maintained. The UMC has previously looked at the way in which the signals it produces have been used in national centres (Edwards and Fucik, 1996).

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