By Edward Li, PharmD, BCOP, Drugs and Biologics Editor
NCCN is pleased to announce that a special edition of JNCCN – The Journal of the National Comprehensive Cancer Network is now available. JNCCN Special Issue: NCCN Oncology Pharmacy and Policy focuses primarily on issues related to pharmacy and drug policy in the United States. It is increasingly important that oncology practitioners stay abreast of both clinical and regulatory aspects of oncology care as the latter have the potential to significantly impact practitioner workload and the delivery of care to patients with cancer. JNCCN Special Issue: NCCN Oncology Pharmacy and Policy provides viewpoints on and a forum for discussion of these issues. Among the topics addressed in this publication is one topic that is currently sparking national discussion and is likely to significantly affect hospitals and oncology practices: Risk Evaluation and Mitigation Strategies (REMS).
Since 2008, the U.S. Food and Drug Administration has had the authority to require a REMS for both existing drugs and drugs in development; the agency determines if special action is needed to ensure that the benefits of a drug outweigh its risks and a REMS requirement is thus applied. Changes resulting from REMS regulations have left clinicians and stakeholders in oncology concerned about burdensome workloads and the possibility of disparities in standard of care.
In response to the impending repercussions of REMS in oncology, NCCN convened an NCCN REMS Work Group. The NCCN REMS Work Group, comprised of various thought leaders and stakeholders in the field of oncology, were charged with gathering information, addressing how REMS should be applied to cancer care, and providing direction for relevant constituents. Additionally, NCCN hosted the NCCN Oncology Summit: Recommendations for REMS Stakeholders (NCCN Oncology Summit), which served as a medium for the presentation of the REMS Work Group’s recommendations and as a forum for further discussion of issues surrounding the development and implementation of REMS in oncology.
Born of these efforts is the final version of the NCCN REMS White Paper, available in JNCCN Special Issue: NCCN Oncology Pharmacy and Policy. This finalized version is a culmination of the recommendations of the NCCN REMS Work Group and also incorporates some points and concepts highlighted at the NCCN REMS Oncology Summit. Data from an NCCN Trends Survey™ collected earlier this year that describes provider knowledge of REMS and preliminary data about how REMS affects provider workload is additionally included.
REMS is only one of the priority topics addressed in JNCCN Special Issue: NCCN Oncology Pharmacy and Policy. In addition to NCCN policy news and an update on recent changes to Medicare Part D, this edition contains reports on two other important, oncology-related matters. First, an update to the 2009 “NCCN Insights Report: Managed Care & Medical Oncology – Cancer Is Now on the Table” reflects on interviews with executives from 10 managed care organizations about the future of managing oncology care. Second, “Insights and Perspectives in the Clinical and Operational Management of Cancer-Related Anemia” details NCCN Member Institution University of Alabama at Birmingham Comprehensive Cancer Center’s initiative to reduce the use of blood products. This report also includes results from three different NCCN surveys on this controversial topic.NCCN is planning another special issue of JNCCN in early 2011. This issue will contain reports similarly relevant to oncology pharmacy and will include clinical case reports that provide continuing education credit. To request a print version of the issue, please contact: email@example.com.