NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper

Recommendations for Stakeholders

Philip E. Johnson, George Dahlman, Kirby Eng, Rekha Garg, Scott Gottlieb, James M. Hoffman, Peyton Howell, Mohammad Jahanzeb, Shirley Johnson, Emily Mackler, Mark Rubino, Brenda Sarokhan, F. Marc Stewart, Tim Tyler, Julie Marie Vose, Sharon Weinstein, Edward C. Li, Jessica DeMartino

Research output: Contribution to journalReview article

15 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalJNCCN Journal of the National Comprehensive Cancer Network
Volume8
Issue numberSUPPL. 7
StatePublished - Sep 1 2010

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Neoplasms
Medical Informatics
Knowledge Bases
Quality of Health Care
Pharmaceutical Preparations

Keywords

  • Oncology
  • REMS
  • Risk
  • Safety

ASJC Scopus subject areas

  • Oncology

Cite this

Johnson, P. E., Dahlman, G., Eng, K., Garg, R., Gottlieb, S., Hoffman, J. M., ... DeMartino, J. (2010). NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders. JNCCN Journal of the National Comprehensive Cancer Network, 8(SUPPL. 7).

NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper : Recommendations for Stakeholders. / Johnson, Philip E.; Dahlman, George; Eng, Kirby; Garg, Rekha; Gottlieb, Scott; Hoffman, James M.; Howell, Peyton; Jahanzeb, Mohammad; Johnson, Shirley; Mackler, Emily; Rubino, Mark; Sarokhan, Brenda; Stewart, F. Marc; Tyler, Tim; Vose, Julie Marie; Weinstein, Sharon; Li, Edward C.; DeMartino, Jessica.

In: JNCCN Journal of the National Comprehensive Cancer Network, Vol. 8, No. SUPPL. 7, 01.09.2010.

Research output: Contribution to journalReview article

Johnson, PE, Dahlman, G, Eng, K, Garg, R, Gottlieb, S, Hoffman, JM, Howell, P, Jahanzeb, M, Johnson, S, Mackler, E, Rubino, M, Sarokhan, B, Stewart, FM, Tyler, T, Vose, JM, Weinstein, S, Li, EC & DeMartino, J 2010, 'NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders', JNCCN Journal of the National Comprehensive Cancer Network, vol. 8, no. SUPPL. 7.
Johnson, Philip E. ; Dahlman, George ; Eng, Kirby ; Garg, Rekha ; Gottlieb, Scott ; Hoffman, James M. ; Howell, Peyton ; Jahanzeb, Mohammad ; Johnson, Shirley ; Mackler, Emily ; Rubino, Mark ; Sarokhan, Brenda ; Stewart, F. Marc ; Tyler, Tim ; Vose, Julie Marie ; Weinstein, Sharon ; Li, Edward C. ; DeMartino, Jessica. / NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper : Recommendations for Stakeholders. In: JNCCN Journal of the National Comprehensive Cancer Network. 2010 ; Vol. 8, No. SUPPL. 7.
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