continuation of methods of spontaneous reporting by professionals but recommended that postmarketing surveillance (PMS) studies should be undertaken on "newly-marketed drugs intended for widespread long-term use''; the report also mentioned record-linkage methods and prescription-based methods of drug safety surveillance as representing areas of possible progress (see Mann, 1987).
Similar reviews and conclusions have emerged from the United States over the last 30 years. A series of events in the United States recently created a resurgence of interest in drug safety evaluation and management. The Prescription Drug User Fee Act (PDUFA) of 1992 provided additional resources at the Food and Drug
Administration (FDA) for drug reviews through user fees, and established target timelines for FDA reviews. The shorter approval times lead to some medications being approved sooner in the United States than in Europe, in contrast to the pre-PDUFA experience. A few highly visible drug withdrawals led to a perception that perhaps drugs were being approved too quickly. In 1998, Lazarou et al. published the results of a metaanalysis that estimated that 106 000 fatal adverse reactions occurred in the United States in 1994 (Lazarou et al., 1998). This and other papers (Wood et al., 1998) stimulated considerable public, Congressional, and regulatory attention on reducing the societal burden of drug reactions and medication errors (FDA, 1999; Institute of
Medicine, 1999; US General Accounting Office, 2000). As a result, greater attention and resources are currently being devoted to signal generation and evaluation by the FDA, industry, and academic centers. Moreover, efforts are underway to develop better tools to manage recognized risks, through a variety of interventions, such as communications with healthcare providers and patients, restricted product distribution systems, and other mechanisms. Additional effort is being focused on measuring the success of these risk management interventions. This new initiative represents a fundamental shift in the safety paradigm in the United States, and offers new challenges to pharmacovigilance professionals.
We have long recognized then that the safety of patients depends not only drug licensing by regulatory bodies but also on post-marketing drug safety surveillance, pharmacovigilance. It is also important to note that the same post-marketing information needed to confirm new safety signals is also needed to refute signals and protect patients' ability to benefit from needed medicines that may be under suspicion due to spurious signals.
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