Prescribing for unlabeled indications.

Little is known about the practice of physicians prescribing drugs for unlabeled (off-label) indications (prescribing approved drugs for indications not listed/approved in the FDA New Drug Application). In order to learn more about this practice, a 17-item questionnaire was administered to 251 physicians, many of whom practiced in some form of managed care setting. Respondents were asked for which of several indications they would prescribe five specific drugs. Some of these indications were labeled (approved by the FDA) while others were not. In addition, respondents were asked to list drugs they thought were commonly used for unlabeled indications. Results indicated that 88% of the physicians used drugs for unlabeled indications. Nearly 25% prescribed off-label daily. Correlations between demographics and prescribing practices were conducted, and descriptive data on sources of information used for new drug uses are described. Efficacy and payment considerations make this subject important for policy and practice decisions.