Conclusion

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Chapter: Pharmacovigilance: Periodic Safety Update Reports

The PSUR can be an important source for the identification of new safety signals, a means of deter-mining changes in the benefit–risk profile.


CONCLUSION

The PSUR can be an important source for the identification of new safety signals, a means of deter-mining changes in the benefit–risk profile, an effective means of risk communication to regulating authorities, an indicator for the need for risk management initiatives as well as a tracking mechanism for moni-toring the effectiveness of such initiatives (Klepper, 2004). It is a useful tool for the MAH and not simply a document for submission to regulatory authorities. One of the major strengths of the PSUR is the unique opportunity it provides to review aggregate data. If a drug is marketed in numerous countries, for example a finding of an ADR of interest across many countries has greater clinical weight than the same finding made in isolated countries. More generally, it is a chance to view all the available information on the safety of a given product – that is information from clinical trials, observational studies and spontaneous report-ing, as well as pre-clinical studies. The consistency (or lack of it) of a potential signal across all these information sources can be extremely valuable to a MAH. The PSUR is also a chance to detect potential problems as patient exposure increases in response to promotional efforts. For example, it may reveal ADRs in elderly people on multiple drug regimes. Such patients may be excluded from clinical trials but their number may increase very quickly after the product has been launched, and the PSUR provides a means of reviewing the relevant safety data in a regular and intelligent manner. Similarly, it is a tool for monitoring the unpromoted use of a drug in sub-populations such as children, the very old and those with multiple diseases, and it can alert manufacturers or sponsors to long latency ADRs or explosive ADRs (when a handful of reports is quickly followed by dozens). The company is then in a position to respond proactively if and when such an event is reported, for example by shifting the promotional programme and product literature away from encouraging expo-sure in what seem to be vulnerable groups. In short, rather than considering the PSUR a tedious piece of compliance with regulatory authorities, compa-nies should regard it as a valuable exercise in which the manufacturer or sponsor thoughtfully assesses benefit and risk and seeks to protect its patients and products.

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