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Old 06-28-2007, 07:43 AM #1
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Default Report on FDA RiskMAP Conference

Thank you to those of you who answered the survey I sent out. The data collected was valuable. It helped with my presentation in ways that will help shape the future of the TOUCH program for those already enrolled and those who will be enrolled.

Many of the problems are associated with not only the enrollment process, but the drug delivery system, the insurance coverage problems, infusion appointments but the biggest problem of all, education. Education of neurologists, education of infusion site staff and education of patients. Education of the enrollment process, but most importantly, education about TOUCH, why it is important, and the reason behind why there is a RiskMAP (Risk Minimization Action Plan) attached to Tysabri. It is a safety precaution and tracking system.

One of the most common threads that we heard was the lack of positive information about Tysabri. The Medication Guide and associated educational tools are slanted towards risk. We recommended that these materials be more balanced.

Let's see if these changes are made and the promises made for better communication to the patients are kept.
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Cheryl
Dx: MS 2001 CRPS 2009




“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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