BACKGROUND: The Prescribing Information (PI) is the US Food and Drug Administration (FDA)'s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers. One challenge with this type of communication is balancing the need to be thorough with the need to be concise.
OBJECTIVES: This study aimed to explore physicians' preferences for and understanding of specific content and formatting in the PI. This study also explored physicians' use of and perceptions of the PI.
METHODS: Seventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians' interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI.
RESULTS: The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., "with or without food") in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list.
CONCLUSION: This qualitative research suggests physicians may prefer more clarity in some sections of the PI.