The FDA-approved and Manufacturer-approved Prescribing Information: Why the Expectation That the Prescriber Has Read...

Based on survey feedback, ~5% of prescribers do not understand the importance of the prescribing information (PI) provided by the U.S. Food and Drug Administration (FDA) and the specific manufacturer of the drug, even though it is provided every time the drug is dispensed. This column addresses 3 representative comments from this subset of prescribers about whether it is an appropriate expectation that the prescriber be familiar with the PI, whether by reading it in its entirety or the first page summary and any additional sections that they wish to know. It also discusses that many, if not all, prescribing "guides" are in fact the PI reformatted for the guide. This column refers the reader back to earlier columns that discuss some of these matters in more detail. This column also addresses comments by 8% of surveyed prescribers about the need for training programs to cover this information for the benefit of prescribers in training and their eventual patients.