Labeling and Patient Medical Information (PMI)

Track:
Regulatory Affairs and Submissions

Day & Time:
June 25, 4:00PM - 5:30PM

Session Number:
274

Room Number:
254AB

Level:
Intermediate

Type:
Session

Title:
Labeling and Patient Medical Information (PMI)

Chair(s):
Lynette Hopkinson
Senior Director, Commercial Regulatory Afairs
Eisai Inc., 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.

Learning Objective(s):
Discuss the regulatory history of patient labeling, particularly CMI and the collaborative efforts undertaken by the healthcare industry and FDA to explore ways to most effectively communicate the most useful prescription medication information to patients: Describe the design and objectives of two more recent pilot programs conducted with a one-page Patient Medical Information (PMI); Identify what patients expect from prescription medication information.

Presentation(s) & Speaker(s):
Evaluation of Two Novel Formats Versus the Current CMI
Julie Aker, MT
President & CEO
Concentrics Research LLC, United States

The PMI Operational Pilot Experience
Paul R. Wilson, MA
Vice President
Catalina Health, United States

Patient Perspective: What Do Patients Want/Need?
Marc M. Boutin, JD
Executive Vice President and Chief Operating Officer
National Health Council, United States