Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs (CDER)

Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs

Recruitment Messages

Patient Support Group Outreach-All Drugs Except Clozapine and Pegvaliase-pqpz

Dear [Patient Support Group Officer Name],

I am a faculty member at Harvard Medical School and Brigham and Women’s Hospital, and I am conducting research on Risk Evaluation and Mitigation Strategy (REMS) programs, which the Food and Drug Administration (FDA) requires the manufacturers of certain medications to implement. My project team and I are seeking to better understand the benefits and burdens of REMS programs on patient care. Our work is being funded by the FDA and does not involve any pharmaceutical companies.

We are requesting your help to invite adult (18 years or above) patients who have initiated [drug name]—a REMS program-covered drug—in the last year to participate in a 60-minute phone interview about their experiences. If you are happy to assist, we ask that you please forward the attached invitation message to your membership list.

If you have any questions or would like to discuss the study in more depth, please contact me at asarpatwari@bwh.harvard.edu. Thank you very much for your help on this important investigation.

Best,

Ameet Sarpatwari, Ph.D., J.D.

Assistant Professor of Medicine at Harvard Medical School

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women's Hospital

1620 Tremont St, Suite 3030

Boston MA 02120

asarpatwari@bwh.harvard.edu