TY - JOUR
T1 - NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper
T2 - Recommendations for Stakeholders
AU - Johnson, Philip E.
AU - Dahlman, George
AU - Eng, Kirby
AU - Garg, Rekha
AU - Gottlieb, Scott
AU - Hoffman, James M.
AU - Howell, Peyton
AU - Jahanzeb, Mohammad
AU - Johnson, Shirley
AU - Mackler, Emily
AU - Rubino, Mark
AU - Sarokhan, Brenda
AU - Stewart, F. Marc
AU - Tyler, Tim
AU - Vose, Julie M.
AU - Weinstein, Sharon
AU - Li, Edward C.
AU - DeMartino, Jessica
PY - 2010/9
Y1 - 2010/9
N2 - REMS are a particularly important issue for oncology and the National Comprehensive Cancer Network (NCCN). A disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders. REMS policies and processes within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions and clinicians. Notwithstanding the potential benefits, the successful design, implementation, and analysis of the FDA's recent requirement for REMS for some high-risk drugs and biologies will present significant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, the NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. The Work Group identified challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, medication guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice.
AB - REMS are a particularly important issue for oncology and the National Comprehensive Cancer Network (NCCN). A disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders. REMS policies and processes within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions and clinicians. Notwithstanding the potential benefits, the successful design, implementation, and analysis of the FDA's recent requirement for REMS for some high-risk drugs and biologies will present significant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, the NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. The Work Group identified challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, medication guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice.
KW - Oncology
KW - REMS
KW - Risk
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=77958158869&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77958158869&partnerID=8YFLogxK
M3 - Review article
C2 - 20947724
AN - SCOPUS:77958158869
VL - 8
SP - S7-S27
JO - JNCCN Journal of the National Comprehensive Cancer Network
JF - JNCCN Journal of the National Comprehensive Cancer Network
SN - 1540-1405
IS - SUPPL. 7
ER -