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. 2013 Mar;9(2):e24-39.
doi: 10.1200/JOP.2012.000620.

Assessment of Risk Evaluation and Mitigation Strategies in Oncology: Summary of the Oncology Risk Evaluation and Mitigation Strategies Workshop

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Free PMC article

Assessment of Risk Evaluation and Mitigation Strategies in Oncology: Summary of the Oncology Risk Evaluation and Mitigation Strategies Workshop

James N Frame et al. J Oncol Pract. .
Free PMC article

Abstract

To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder presentations and topical panel discussions addressed REMS program development, implementation processes, and practice experiences, as well as oncology drug safety processes. A draft REMS decision tool prepared by the ASCO REMS Steering Committee was presented for group discussion with facilitated, goal-oriented feedback. THE WORKSHOP IDENTIFIED SEVERAL UNINTENDED CONSEQUENCES RESULTING FROM CURRENT ONCOLOGY REMS: (1) the release of personal health information to drug sponsors as a condition for gaining access to a needed drug; (2) risk information that is not tailored-and therefore not accessible-to all literacy levels; (3) exclusive focus on drug risk, thereby affecting patient-provider treatment discussion; (4) REMS elements that do not consider existing, widely practiced oncology safety standards, professional training, and experience; and (5) administrative burdens that divert the health care team from direct patient care activities and, in some cases, could limit patient access to important therapies. Increased provider and professional society participation should form the basis of ongoing and future REMS standardization discussions with the FDA to work toward overall improvement of risk communication.

Figures

Figure A1.
Figure A1.
Itinerary of the Risk Evaluation and Mitigation Strategies (REMS) workshop. ETASU, Elements to Assure Safe Use; FDA, US Food and Drug Administration.
Figure A2.
Figure A2.
Chemotherapy checks and balances presented at the Oncology REMS Workshop from the David Lee Cancer Center, Charleston Area Medical Center Health Systems, Charleston, WV. ONS, Oncology Nursing Society. (Provided by James N. Frame, MD, FACP). CPOE, computerized physician order entry.
Figure A3.
Figure A3.
Chemotherapy checks and balances with an electronic ordering system at a comprehensive cancer center (Ohio State University Comprehensive Cancer Center-The James, Columbus, OH). CPOE, computerized physician order entry; EMR, electronic medical record; ONS, Oncology Nursing Society; PharmD, doctor of pharmacy; RN, registered nurse. (*) Patient education documents are developed internally. Education is always provided verbally and reinforced with written documents. (†) Body surface area automatically calculated upon entry of height and weight. (‡) Five rights: patient, drug, dose, route, time.
Figure A4.
Figure A4.
Text extracted from REMS materials to illustrate content written at a high health literacy level. Example 1 (A) is a list of warnings from the first page of every Revlimid patient-physician agreement form (Celgene: Revlimid (lenalidomide) 1.16 risk management plans: NDA 21-880 http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM222644.pdf). Example 2 (B) is the Patient Authorization for Disclosure and Use of Health Information Statement from the FOCUS (Full Ongoing Commitment to User Safety) program for Onsolis (Onsolis fentanyl buccal soluble film, page 83. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000PrescriberInfo.pdf). The Revlimid document was approved on August 3, 2010 and is still in use; the Onsolis document was approved on July 16, 2009 and was discontinued on December 28, 2011 after FDA adoption of a shared system REMS for transmucosal immediate-release fentanyl products (US Food and Drug Administration: Approved risk evaluation and mitigation strategies (REMS). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm). FDA, US Food and Drug Administration.
Figure A4.
Figure A4.
Text extracted from REMS materials to illustrate content written at a high health literacy level. Example 1 (A) is a list of warnings from the first page of every Revlimid patient-physician agreement form (Celgene: Revlimid (lenalidomide) 1.16 risk management plans: NDA 21-880 http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM222644.pdf). Example 2 (B) is the Patient Authorization for Disclosure and Use of Health Information Statement from the FOCUS (Full Ongoing Commitment to User Safety) program for Onsolis (Onsolis fentanyl buccal soluble film, page 83. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000PrescriberInfo.pdf). The Revlimid document was approved on August 3, 2010 and is still in use; the Onsolis document was approved on July 16, 2009 and was discontinued on December 28, 2011 after FDA adoption of a shared system REMS for transmucosal immediate-release fentanyl products (US Food and Drug Administration: Approved risk evaluation and mitigation strategies (REMS). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm). FDA, US Food and Drug Administration.

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