DIA 48th Annual Meeting
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REMS: Are Our Written Communications Truly Mitigating Risks to Patients?
Track : Track 14: Clinical Safety and Pharmacovigilance
Program Code: 342
Date: Wednesday, June 27, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Sally Van Doren, Biosoteria, Inc., United States
PRESENTER (S):
 Sally Van Doren, Biosoteria, Inc., United States
 Kala Paul, The Corvallis Group LLC, United States
 Herbert Lee, Medcomm Solutions, LLC, United States
Description
This session will discuss and present information on which REMS communication tools have actually been shown to positively influence prescriber and patient knowledge and behaviors leading to mitigation of product risk in patients. Published papers on past communication effectiveness will be reviewed. The importance of what and how a communication is written will be discussed for effective communication practices. New innovative approaches to communication beyond paper information leaflets will be presented.

Learning Objectives:
Discuss the current recommended REMS tools for mitigating risks to patients
Compare what tools have been shown in past published studies to be effective (or not) in mitigation of patient risks
Describe effective communication methods and new non-paper based patient and health care provider communication tools being used in practice.