DIA 2013 49th Annual Meeting
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Labeling and Patient Medical Information (PMI)
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 274
Date: Tuesday, June 25, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 254AB
CHAIR :
 Lynette Hopkinson, (SPKNON), Senior Director, Commercial Regulatory Afairs, Eisai Inc., United States
SPEAKER (S):
Julie Aker, MT (SPKNON), President & CEO, Concentrics Research LLC, United States
Paul R. Wilson, MA (SPKNON), Vice President, Catalina Health, United States
 Marc M. Boutin, Esq, JD (SPKSUP), Executive Vice President and Chief Operating Officer, National Health Council, United States
Description
Currently three documents serve to communicate patient product information, the Patient Package Insert (PPI), Medication Guide, and Consumer Medication Information (CMI). None are deemed optimal as a 'One Document Solution'. Over the past 20 years FDA has collaborated with multiple healthcare stakeholders to explore how to effectively communicate the most useful prescription medication information to patients. This session will discuss two pilot projects that were conducted with one-page Patient Medical Information (PMI) samples to determine, amongst other objectives, patient comprehension and patient preferences for format, content and method of receipt.