Safety data

• spontaneous ADRs

• epidemiology studies

• clinical trials

• pre-clinical data

Signal generation Signal evaluation Risk-benefit review Expert advice Decision-making

Decision Communication

• bulletin article

Figure 14.1. Regulatory pharmacovigilance.

likely to be identified in the first few years after marketing, although new issues also arise with long-established drugs. In order to ensure that safety problems which have not been recognised or fully understood pre-marketing are handled promptly, proactive processes are used for screening emerging data for potential issues and bringing together all the available information from multiple sources. In regulatory practice, a signal is an alert from any available source that a medicine may be associated with a previously unrecognised hazard, or that a known hazard may be quantitatively (e.g. more frequent) or qualitatively (e.g. more serious) different from existing expectations.

The commonest source for identification of significant drug safety concerns arising with marketed medicines is spontaneous suspected adverse reaction reporting. These are individual case reports from health professionals of adverse events which the reporter considers may be related to the medicine(s) being taken. Reporters are not asked to provide all adverse events that follow administration of the medicine but to selectively report those which they suspect were adverse reactions. There is frequently confusion between the terms "adverse event'' and ''adverse reaction'' which can be avoided by using the term ''suspected adverse reaction'' when referring to a case or series of cases reported through a spontaneous reporting scheme. The term ''adverse event'' should be used in the context of studies where all events are being collected regardless of where or not they are suspected to be related to a drug. This approach is underpinned by standard definitions given in European legislation (Title I of Directive, 2001/83/EC) and is also consistent with defini tions proposed by the ICH in guideline E2A (D'Arcy and Harron, 1995).

Although formal studies of drug safety are particularly used in the investigation of signals generated by methods such as spontaneous ADR reporting (i.e. hypothesis-testing), they may also provide the initial evidence producing a safety concern. Signals may also be detected from other sources such as literature reports and from screening of the international spontaneous reporting database operated by the Uppsala Monitoring Centre in Sweden, a Collaborating Centre of the World Health Organization (Uppsala Monitoring Centre, 1998), to which all EU Member States contribute data. Whatever the source of the signal, the aim is to identify it as rapidly as possible. The next steps are to inform other Member States, gather further information and conduct an evaluation.

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