Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling

Policy Brief / Workshop Summary

The US Food & Drug Administration (FDA) helps to ensure that prescribing information (PI) communicates essential drug interaction (DI) information as part of the FDA's public health mission to assure the safe and effective use of drugs marketed in the US. To obtain input on how to best communicate DI information in PI, including the DRUG INTERACTIONS section, the FDA and Duke-Margolis convened a stakeholder workshop in October 2019 and a follow-on meeting in December 2019. Meeting participants included academic physicians, retail and clinical pharmacists, nurse practitioners, academic researchers, drug database publishers, drug developers, informaticists, and representatives from the FDA. This workshop summary presents participant feedback from these meetings.

This workshop summary reflects the views of the individual authors and should not be construed to represent the views,
policies, or nomenclature of the U.S. Food and Drug Administration.