Identification and evaluation of safety signals from spontaneous reports can result in a range of regulatory actions.
REGULATORY ACTION BASED ON
SPONTANEOUS REPORTS
Identification
and evaluation of safety signals from spontaneous reports can result in a range
of regulatory actions. These may include one or more of the following:
·
Change to the manufacturer’s professional and/or patient
labeling.
·
Implementation of a Risk Management Action Plan (RiskMAP).
·
Market withdrawal of the product.
·
Further study of the safety concern.
Nearly
all postmarketing safety labeling changes for drugs are based on spontaneous
case reports. In 2005, the average number of such safety label-ing changes for
drugs per month was approximately 40. A RiskMAP (Guidance for Industry, 2005)
may need to be implemented when labeling and routine pharmacovigilance alone
are not considered suffi-cient to manage the risks of the product. In these
instances, further measures, such as targeted educa-tion and controlled product
distribution, might need to be implemented to help assure its safe and
effec-tive use. Withdrawal of the drug from the market may be necessary on
occasion. Further study may also be needed or desirable, either alone or in
conjunc-tion with any of the above actions, to refine the nature and/or extent
of the safety concern. In some situations, a fair assessment of a safety
concern can only be achieved through such study. For example, in situations
where the underlying disease being treated and the ADR resulting from treatment
are the same, only a well-conducted randomized trial will convinc-ingly
establish the drug–ADR association. Such was the case with encainide and
flosequinan, which were removed from the market after randomized clini-cal
trials identified an increased mortality risk (Echt et al., 1991; Massie et al.,
1993). This risk would have been
difficult, if not impossible, to identify with spontaneous reports alone. The
concept of risk management or risk minimization as applied to phar-maceuticals
is relatively new. Research into the effec-tiveness of various regulatory
interventions intended to substantially improve a drug’s benefit–risk balance
has shown that generally speaking, such interven-tions frequently are
inadequate and do not improve the safety profile of medicines (Graham et al., 2005). Additional approaches to
risk management are needed (Andrews, Gilsenan and Cook, 2004).
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