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.

To become a certified prescriber go to www.accessdata.fda.gov/scripts/cder/rems.

Patient Enrollment Required - YES Patient Informed Consent Required – YES Medication Guide - YES

I need to develop a list of reasons for the prescriber/RN/RPh to select for each role. Prescriber - I have completed the require REMS Program documents, I have checked pregnancy status, etc.

Please provide any suggestions for the reason list.

Joseph T. Moss, Jr., PharmD, MBA
System Clinical Informatics Pharmacist
UH Case Medical Center
11100 Euclid Avenue, Wearn 102
Mail Stop: WRN 5006
Cleveland, OH 44106
Office: 216-844-4248
Cell: 330-416-9715
Fax: 216-844-3052
Joseph.Moss@UHhospitals.org