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

Workshop Description

Unanticipated, unrecognized, or mismanaged drug interactions are an important cause of morbidity and mortality associated with prescription drug use and have occasionally contributed to the withdrawal of approved drugs from the market  (U.S. Food and Drug Administration 2017). The DRUG INTERACTIONS section of prescription drug labeling (or Prescribing Information) is designed to provide end-users with clinically relevant information about potential and known drug interactions to support the safe and effective use of prescription drugs. Information included in the DRUG INTERACTIONS section, and associated clinical decision support tools, is used to inform the process of prescribing, dispensing, and administering medications, and its optimization is important for patient care delivery.

Accordingly, the Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a stakeholder workshop to discuss how to best communicate clinically significant drug interaction information in the Prescribing Information. This workshop will explore the real-world use of drug interaction information, including how this information is used by health care providers during care delivery and curated by third-party drug information providers for clinical decision support tools. The workshop will discuss how to provide clear, useful, consistent, and understandable information in the Prescribing Information about clinically significant drug interactions, their mechanisms and clinical implications, and instructions for preventing or managing them. The stakeholder discussion will provide FDA with information about how the DRUG INTERACTIONS section is used by health care providers and drug information providers, as well as preferences for the presentation of this information in the Prescribing Information to support safe and effective prescription drug use.

The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.

Policy Brief / Workshop Summary

Read the associated policy brief here.