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

Email to Forward to Patient Group Membership-All Drugs Except Clozapine and Pegvaliase-pqpz

Dear [Patient Support Group Name] Members,

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 would like to extend an invitation to those of you who are 18 years or above and have started taking [drug name]—a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on your experiences. Your participation is voluntary. If you choose not to take part, it will not affect your affiliation with your support group in any way. If you choose to take part, your answers will be treated confidentially, and you will receive a $50 Amazon gift card as a token of appreciation for your participation.

If you meet the above condition and are interested in participating in the study, please email me at [email protected] with the subject line “REMS Patient Interview.”

Thank you very much for your consideration of our invitation.

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

[email protected]