REMS

PS-Mycophenolate REMS

Janine Smentkowski's picture

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Is anyone aware of any changes needed with the new "PS-Mycophenolate REMS program" approved 6/1/2023?

In comparison to the old REMS, the goals are the same and the prescriber form states "If you have previously completed the requirements of another Mycophenolate REMS, it is not necessary to complete the PS-Mycophenolate REMS.

I am a little confused as to why there is a second REMS program? Does not appear that the old one was removed or that providers need to resubmit a new prescriber training form. Maybe I am missing something?

REMS programs for oversight within health-systems

Joel W Daniel's picture

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How is everyone else setting up their REMS programs?

Do you have specified people who have a delineation of roles (ensuring that all aspects are incorporated, education, auditing, electronic rules, etc.)? I'm looking to set something up that can become hardwired and not reliant on periodic audits.

Thank you,
Joel

REMS Reason List to Place Order

Joseph Moss's picture

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Everyone,

I an interested in learning how your organization approaches REMS Alerts for the clinician/prescriber to acknowledge to order these agents.

We have an alerts built in our CPOE system to inform prescriber what actions they need to complete to order REMS agents.

Example: REMS Alert

FDA REMS DRUG - By ordering this medication I acknowledge that I have completed the FDA REMS certification requirements and I am an authorized prescriber.

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