The notion of "acceptable risk": the role of utility in drug management.

This paper presents a definition of "acceptable risk" that is based on the concept of utility. The adverse effects of a specific use of a drug pose an acceptable risk if no alternative treatment has a higher cumulated expected utility in the relevant patient population than that associated with the use of the drug. The implications of this definition for postmarketing management of drugs are explored. In particular, postmarketing surveillance should be expanded to include the quantification of patients' values, a drug's beneficial effects, and its adverse effects. Management actions should be targeted at specific drug uses with unacceptable risks rather than at drugs themselves. This may require the use of education and service action options, as well as regulatory actions aimed at prescribers and dispensers.