Scientific Publications by FDA Staff

J Am Board Fam Med 2014 Sep-Oct;27(5):694-8

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

Sullivan HW, O'Donoghue AC, Aikin KJ

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: Physicians viewed PI sections in order, most often viewing sections relevant to safe use, such as Warnings and Precautions and Dosage and Administration. When asked to think about the drug's efficacy, many viewed the Clinical Studies section. Viewing certain PI sections was associated with greater perceived risk and lower perceived benefits and intention to prescribe. CONCLUSIONS: These results suggest that the information in the PI could affect physician decision making and do not support further reorganization of the PI.