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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