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?

UIC Illinois - ADVANCE is offering virtual academic detailing to prescribers, nurses, pharmacists for safe opioid prescribing as part of an FDA-REMS grant. Each virtual visit is 15-20 minutes and provides 0.5 contact hours of CME/CPE/CNE. See attached flyer or visit https://academicdetail.pharmacy.uic.edu/

Does your facility consider REMS medications to be high-alert? It would seem to me that they meet the definition of "medications are most likely to cause significant harm to the patient, even when used as intended."

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

Hi there!

Just curious if anyone has any unique systems developed for management of REMS medications throughout their healthcare system?

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.