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.[1] 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.

中文翻译：

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医生对 FDA 批准的处方信息的使用和偏好

背景

处方信息 (PI) 是美国食品和药物管理局 (FDA) 的主要工具，用于向医疗保健提供者传达安全有效使用处方药所需的基本科学信息摘要。 [1] 这种沟通方式的一个挑战是平衡全面的需求和简洁的需求。

目标

本研究旨在探讨医生对 PI 中特定内容和格式的偏好和理解。这项研究还探讨了医生对 PI 的使用和看法。

方法

使用网络会议技术对初级保健医生 (n = 35) 和来自广泛专业的医生 (n = 35) 进行了 70 次半结构化定性访谈。使用虚构的 PI 示例，该指南评估了医生对语言的解释以及对如何在 PI 的选定部分中组织和传达某些信息的偏好。访谈指南还包括有关医生用来查找处方药信息的资源、医生何时以及如何访问 PI 以及他们对 PI 的看法的问题。

结果

调查结果表明，在调查的内容和格式项目中，医生最喜欢：(1) 在适应症和使用部分统一指定药物适用的年龄组，即使是与仅与药物高度相关的医疗条件一个特定的年龄组（例如，成年患者），以及 (2) 在口服药物的剂量和给药部分统一包括与食物有关的给药信息（例如，“有或没有食物”）。研究结果还表明，在“药物相互作用”部分中包含一长串相互作用的药物示例可能会被误解为综合列表。

结论

这项定性研究表明，医生可能更喜欢 PI 的某些部分更加清晰。