Overdose Information in Prescription Drug Labeling

Background

The U.S. Food and Drug Administration (FDA)-approved labeling for prescription drugs (referred to as prescription drug labeling (PDL)) is FDA’s primary tool for communicating the summary of the essential scientific information necessary for safe and effective use of prescription drugs. PDL includes the Prescribing Information (PI) for health care practitioners (HCPs) and may also include labeling for patients (and their caregivers, if applicable). Because the PI is specifically written for HCPs, it is important for FDA to understand HCP preferences for specific content in the PI. Similarly, it is important for FDA to understand patient preferences for and understanding content in labeling for patients.

Accordingly, Duke-Margolis convened a private virtual roundtable to gather insights from diverse group of participants (for example, HCPs [emergency department physicians, intensivists, nurse practitioners, pharmacists, physician assistants], drug information experts, pharmaceutical company representatives, medical toxicology experts, health literacy experts, and labeling experts) to understand their needs and preferences for overdose information in the PI. This input will help inform future policy development to improve overdose information in PDL.

Funding Acknowledgement

This roundtable is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $5,045,773 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.