other researchers regarding drug products and their use in clinical practice. Also required are improvements in the way drug information is presented to providers and consumers through labeling and packaging since such materials have a direct effect on medication errors and adverse drug events (ADEs). This section reviews key problems involved in the generation and presentation of information that should be addressed by the pharmaceutical industry and the Food and Drug Administration (FDA).

Generation of Information

Current methods for generating information about medications are insufficient to meet the changing medical needs of the population, particularly given expected increases in the numbers of elderly people with multiple chronic conditions (IOM, 2000, 2001). While a comprehensive review of the drug research and development process and recommendations for its redesign are beyond the scope of this report, certain key aspects of information generation germane to medication safety merit discussion here.

Clinical Data

Determining that a medication error has occurred presumes that the correct dose of a drug for a given patient at a particular time is known, and that the indication for that drug is correct relative to alternative approaches to treatment. Unfortunately, this fundamental presumption is too often unwarranted.

The benefits of drugs can be categorized as improvement in longevity, improvement or stabilization of symptoms (improvement in quality of life), prevention of adverse events, or reduction in the costs of other medical interventions. To determine whether the benefits of a drug outweigh its risks, both the benefits and the risks must be measured in the population to whom the drug will be given for a relevant period of time (Yusuf et al., 1984; Prentice, 1989; Fleming and DeMets, 1996). Ideally, after these measurements have been made, individuals should be informed about both the benefits that can be expected and the potential risks. Since the benefits and risks are measured with different metrics, it is important to recognize that in the end, a subjective judgment regarding the balance of benefit and risk is necessary, since a ratio cannot be calculated (CERTS, 2003; Tsintis and La Mache, 2004; Edwards et al., 2005).

Over the past several decades, our understanding of therapeutic evaluation has advanced significantly. Nonetheless, the balance of benefit and risk of a drug compared with alternative treatments usually is not known. A variety of examples can be used to illustrate this point. Hormone replacement therapy, for instance, was once the most prevalent drug prescription



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