Identifying Drug Safety Issues

Assessment of drug safety involves bringing together all the available information from multiple sources (Figure 9.2). It begins with the basic pharmacological and pre-clinical studies and should continue until the end of potential sequelae of marketing exposure, a period which may span many decades. Potentially important drug safety issues can be identified at any stage of drug development. In the post-marketing phase they are particularly likely to be identified in the first few years after marketing, although new issues also arise with long-established drugs. There are several reasons why important drug safety issues may not be detected until after marketing, and these are listed in Table 9.1.

In order to ensure that safety problems that have not been recognised or fully characterised pre-marketing are handled promptly, proactive processes are required for screening emerging data for potential issues. At the stage of initial identification, it is unusual for it to be clearcut that the hazard is drug-related and this has led to the concept of "signalling". Alternative terms that may be regarded as synonymous in this context are "alerting", "early warning" and "hypothesis-

Pre-clinical studies

Clinical trials

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