FDA News: Issue 1, January 2022

Author: [AUTHOR] Published on 1/14/2022 5:00:00 AM

New FDA and Duke-Margolis Workshop Summary Recaps Participants’ Feedback on Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling

On December 15, 2021, the US Food & Drug Administration (FDA) in collaboration with Duke-Margolis Center for Health Policy, published a workshop summary titled Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling. This workshop summary highlights participant discussion regarding challenges managing drug interactions in the clinical setting and their input on how best to communicate drug interaction information in prescribing information from a co-sponsored workshop held in October 2019 and a follow-on meeting in December 2019. The meeting participants included academic physicians, retail and clinical pharmacists, nurse practitioners, academic researchers, drug database publishers, drug developers, informaticists, and representatives from the FDA.

Drug interactions are a significant source of preventable adverse reactions. In clinical settings, health care practitioners (HCPs) rely on a combination of their own knowledge and experience, the prescribing information, and other drug information resources to identify, reduce the risk of, and manage drug interactions. However, information regarding the risks of interactions with prescription drugs have increased in breadth and complexity over the past decades, making it more difficult for HCPs to find and effectively apply specific drug-interaction information in practice. As part of the FDA's public health mission, the agency helps to ensure that the prescribing information communicates essential drug interaction information to assure the safe and effective use of drugs marketed in the US. Third-party drug information publishers often use the prescribing information as a resource for publishing drug interaction information and developing clinical decision support software used by HCPs to support clinical decision making and drug dispensing. 

This workshop summary captures the meeting participants discussion regarding the role of prescribing information in communicating drug interaction information including suggestions for improvements related to the clarity, density, format, and reliability of the drug interaction information in the document. Further, the participants also discussed challenges that HCPs face in identifying and managing drug interactions in the clinical setting with currently available resources and provided valuable input regarding potential solutions for more consistent drug-interaction information in the prescribing information and across publications and platforms (e.g., drug information databases, electronic health records, and clinical decision support software).  Statements made in the published summary are attributable to non-FDA meeting participants unless otherwise noted.

More details regarding the workshop summary can be found here. To learn more about prescription drug labeling, visit https://go.usa.gov/xtaQA.


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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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