five percent of the adults interviewed in the 2004 Slone Survey reported taking at least one prescription drug in the week prior to the interview, and 11 percent reported taking five or more such drugs (Slone, 2005). In the same survey, 42 percent of the adults surveyed reported taking vitamins and 19 percent herbal or other natural supplements.

Another key contextual issue is ongoing cost containment efforts. In recent years, these efforts have failed to limit increases in health care costs to the general inflation rate or less. National health spending in 2003 was $1.679 trillion, an increase of 7.7 percent over the previous year (Smith et al., 2005). This growth rate is not much below that for the previous year; in 2002 national health spending increased 9.3 percent over that in 2001 (Levit et al., 2004). U.S. prescription drug sales have been rising more rapidly yet. IMS Health Inc., a leading provider of information and consulting services to the pharmaceutical and health care industries, reported that prescription drug sales in the United States grew 8.3 percent to $235 billion in 2004, compared with $217 billion the previous year (IMS, 2005). This increase followed an 11.5 percent growth in 2003 over 2002 and an 11.8 percent growth in 2002 over 2001 (IMS, 2003, 2004). One critical implication of these figures relevant to this study is that efforts to control health care costs at the federal and state levels and within health care organizations mean that any new investments, including investments in medication safety, will need to be thoroughly justified.

Efforts to contain health care costs have had limited success because of a number of important cost drivers (IFoM, 2003). Innovative new pharmaceuticals are displacing older agents, which are usually cheaper because they are off patent. An aging population is leading to higher consumption of health care in general and pharmaceuticals in particular. A more demanding patient population is less accepting of restrictions on health care use for cost containment reasons. And a broader definition of treatable disease is increasing the demand for health care. Implementation of the Medicare prescription drug benefit is also likely to increase the demand for pharmaceuticals. The Administration’s Financial Year Budget projected that the net federal cost of the Medicare prescription drug benefit would be $37.4 billion in 2006, rising to $109.2 billion in 2015 (Kaiser Family Foundation, 2005).

The FDA is a key player in ensuring the safety of medications, both prescription and nonprescription. The FDA approves a drug for sale in the United States after determining that its clinical benefits outweigh its potential risks. After a drug has been approved, the FDA continues to assess its benefits and risks, primarily on the basis of reports made to the agency on the effects of its use. In 2004, withdrawal of the drug rofecoxib (Vioxx) by Merck & Co. Inc. for safety reasons increased public concern about the procedures used for assessing drug safety. In response to this concern, the



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