Background

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Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

The test of the effectiveness of regulatory systems is their performance in responding to emerging drug safety hazards to identify, evaluate, manage and communicate risk in the context of benefit.


BACKGROUND

The test of the effectiveness of regulatory systems is their performance in responding to emerging drug safety hazards to identify, evaluate, manage and communicate risk in the context of benefit. Recent significant drug safety issues handled in the European regulatory framework and the evidence which trig-gered them are shown in Table 44.1.


The withdrawal of cerivastatin in 2001 following spontaneous reports of cases of serious and fatal rhab-domyolysis represented a regulatory milestone. The extent of use of cerivastatin in Europe meant that wide public debate ensued. This debate was reignited on an international scale in September 2004, when Merck withdrew rofecoxib, a selective cyclo-oxygenase 2 inhibitor widely used in the treatment of arthritic pain, because of clinical trial evidence of an increased risk of heart attack and stroke.

While high-profile drug withdrawals have been the focus of detailed public scrutiny, evidence has contin-ued to gather of the general burden of adverse drug reactions in public health terms. Research conducted in the United States by Lazarou concluded that adverse drug reactions in 1994 were between 4th and 6th leading cause of death (Lazarou et al., 1998). A recent prospective analysis in the United Kingdom by Pirmohamed et al. gave a similar estimate; about 6.5% of hospital admissions were related to an adverse drug reaction (ADR) with a 0.15% incidence of fatal ADRs (Pirmohamed et al., 2004).

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