Replacing Medication Guides, patient-package inserts, and other consumer medication information handed out at pharmacies with a proposed Patient Medication Information (PMIs) sheet—a single document with standardized content and format—is a goal for the FDA's drugs center. The agency is testing several formats and will need to draft a regulation in order to implement the program in the near future, Division of Medical Policy Programs director Bryon Pearsall told a Regulatory Affairs Professionals Society conference session in Seattle on Oct. 28.
Today's system for patient information is burdensome, Pearsall says, and surveys have shown that often Medication Guides are not making it into patients' hands.
CDER's proposed framework for PMIs is broken into four sections—Development, Central Repository, Distribution, and Quality Surveillance. For development, according to Pearsall, the Center's thinking is to make manufacturers responsible for creating the PMI sheets. “Content, format and testing standards will dictate PMI design and composition,” he told the RAPS session. He said the agency will propose minimum font sizes, testing standards (similar to OTC drug usability standards) and evaluation metrics.