Physicians View FDA-Required REMS Program as a Potential Barrier to Prescribing Erythropoiesis-Stimulating Agents
CAMBRIDGE, Mass., Oct. 21 /PRNewswire/ -- Sermo (http://www.sermo.com), the largest online community for physicians, today announced a free Sermo Report titled, "Physician Participation in the ESA REMS Program." The report covers physician perceptions and participation rates in the FDA-required Erythropoiesis-Stimulating Agents (ESAs) risk evaluation and mitigation strategy (REMS) program.
According to the results, 83% of Hematologists/Oncologists view the ESA REMS program as a barrier to utilization of associated drugs. As one HemOnc noted, "The purpose of REMS is to reduce patient access to ESAs, or more accurately to reduce their demand by scaring them away, and also by limiting the supply of physicians who are willing to put up with the work for little return."
This free Sermo Report polled 60 physicians who also participated in an online discussion regarding treatment strategies for renal associated anemia.
Highlights from the report include:
- Physicians are not aware of how to participate in the REMS program. If they have participated, it was most likely required by their place of employment. "Gov't said I had to," said a HemOnc respondent. "Nice way to pass the buck of blame to doctors."
- REMS programs are perceived by physicians as more work, and reduced access for the patient. According to a HemOnc respondent, "REMS programs simply transform pharma liability risk into more work for physicians… I would rather not even prescribe a drug than generate more busywork for me or my staff. So this reduced prescribing of a REMS drug translates into reduced access for the patient."
The full reports includes:
- Key Findings
- Physician Demographics
- Quantitative and Qualitative Analysis
Physicians are required to complete the ESA REMS program by March 2011 to be eligible to prescribe these products. The goals of the REMS for ESAs are:
- To support informed decisions between patients, their physicians, and other healthcare professionals by educating them on the risks of ESAs.
- To mitigate the risk of decreased survival and/or poorer tumor outcomes in patients with cancer by implementing the part of the REMS called the ESA APPRISE Oncology Program.
Erythropoiesis Stimulating Agents include products from Amgen and Centocor Ortho Biotech Products, L.P.
To download report results, visit sermo.com/client.
About Sermo Reports
Sermo Reports solicit perceptions and opinions from physicians about new drugs, devices, treatments, and trends. Data for Sermo Reports is gathered through Sermo Posts, which allow physicians to participate in a poll and comment on the topic. All physicians on Sermo are verified and credentialed.
Sermo is the largest online physician community, where over 115,000 practicing physicians discuss a wide range of issues from clinical cases to advice about drugs and practice management. By leveraging Sermo's social media platform, clients can tap into unsolicited, peer-to-peer dialog and engage MDs to gain market intelligence and increase brand awareness. For information, visit www.sermo.com/clients.