Primary Care Physicians' Use of FDA-Approved Prescription Drug Labels

Abstract

Background: In 2006, the US Food and Drug Administration reorganized the approved label format and content for prescription drugs -also known as the prescribing information (PI). This research examines primary care physicians' use of the new PI and how it may influence their perceptions about prescription drugs.Methods: A total of 500 physicians responded to an Internet survey that displayed an interactive PI for a fictitious combination pain relief/heart attack-reducing drug. The physicians answered questions about perceived risk, perceived benefit, and intention to prescribe that focused on either the treatment indication or the prevention indication.Results Keywords: Drug Labeling, Prescription DrugsEach successful prescription drug application to the US Food and Drug Administration (FDA) results in FDA-approved product labeling, known as prescribing information (PI). The PI details pertinent information about the drug, such as contraindications, and contains essential information for the practice of medicine. It accompanies the product, is available online-including on the FDA's website (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm) and the Physician's Desk Reference website (http://www.pdr.net)-and forms the basis for information found in other physician platforms, such as Epocrates.Based on research and public input, the FDA reorganized the PI in 2006 to make it more user friendly.1,2 The PI for many products (and all new products' PI) now follow the new format. It includes a table of contents and a highlights section, which provides an overview of the PI. Studies of physicians' use of PI predate these changes.3-6 Because the PI is the basis for many sources of physician information, it is critical to understand how physicians process the revised PI. This study is designed to examine how physicians search for medical information 7-9 by assessing physicians' use of the PI and how it may affect physicians' perceptions of the drug. Methods ProcedureParticipants were recruited from an opt-in internet panel of more than 100,000 physician members of the American Medical Association. To be included, their primary area of specialization had to be family practice, general practice, or internal medicine and they had to report spending 50% or more of their time on direct patient care. We created a PI for a fictitious drug, Gilarix, indicated to reduce chronic pain (treatment indication) and the risk of heart attack (prevention indication). Participants viewed the PI twice: First, they were asked to attend to the PI to help the FDA improve its presentation (task 1). Second, they were asked to focus on the drug's efficacy (task 2). For both tasks, participants first saw the Contents page, with a hyperlink for the title of each section and subsection (eg, Contraindications). Within each section, participants could move back to the previous section, move forward to the next section, or go to the Contents or Highlights pages to choose another section to view. After viewing the PI for as long as they l...

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