Regulatory Action Based on Spontaneous Reports

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Chapter: Pharmacovigilance: Spontaneous Reporting - United States

Identification and evaluation of safety signals from spontaneous reports can result in a range of regulatory actions.


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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