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1 - - - takemurar@adm.ncn.ac.jp Use of a New Drug Risk Management Plan for Cancer Nursing to Facilitate Safe Pharmacotherapy Reiko Takemura Keiko Iino Namiko Nagaoka National College of Nursing Japan : - - Umezono, Kiyose-shi, Tokyo, -, Japan Abstract Drug Risk Management Plan RMP is an official document concerning the safety of drugs. Since April, RMPs have been prepared for each drug for which an application for approval has been made. RMPs specify the safety specification for individual drugs, such as important side effects, and document pharmacovigilance plans e.g., post-marketing side effects surveys and risk minimization action plans. Previously, the documentation accompanying the drug did not provide sufficient information on the management of side effects or information for patient guidance. The risk minimization part of RMP requires development of materials for medical professionals and patients based on guidance from the Pharmaceuticals and Medical Devices Agency. The use of RMPs as a new information source in the field of cancer nursing, including presentation of different treatment methods based on side-effect grade, needs to be investigated. We present an outline of RMP and report the initiatives that are being implemented for drug risk minimization in cancer nursing in the United States, where RMPs have been used for some time. Keywords risk management plan risk evaluation and mitigation strategies drug safety and risk management oncology nursing Risk Management Plan RMP RMP,,, RMP Pharmaceutical and Medical Devices Agency PMDA J Nurs Studies NCNJ Vol. No.

2 図1 厚生労働省図2 医薬品リスク管理計画における医薬品安全性監視計画とリスク最小化計画厚生労働省国立看護大学校研究紀要医薬品リスク管理計画における安全性検討事項の特定医薬品医療機器等安全性情報 No.300 より転載 2016 年 8 月 1 日アクセス医薬品医療機器等安全性情報 No.300 より転載 2016 年 8 月 1 日アクセス第 16 巻第1号 2017 年 28

3 ABC 1mg RMP ABC 1mg ABC 2mg DEF ABC 3mg ABC OD 1mg ABC OD 2mg ABC OD 3mg 87*** https // RMP RMP RMP Web MR RMP RMP RMP RMP EU EU International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use ICH J Nurs Studies NCNJ Vol. No.

4 ICH RMP ICH EU EU EU- RMP Risk Evaluation and Mitigation Strategy REMS RMP PMDA RMP http // rmp/.html 1 RMP RMP RMP %, % PS Koyi et al., RMP 2 PMDA RMP

5 PMDA PMDA RMP RMP 3 PMDA RMP RMP RMP RMP Common Terminology Criteria for Adverse Events CTCAE, CTCAE / / / mg/kg/ RMP RMP J Nurs Studies NCNJ Vol. No.

6 RevMate RevMate QT QT Torsade de pointes QT Torsade de pointes e-learning 1 REMS oncology REMS Risk Evaluation and Mitigation Strategy PubMed REMS National Comprehensive Cancer Network NCCN REMS Johnson et al., QT REMS REMS Medication Guide Communication Plan Elements to Assure Safe Use ETASU Johnson et al., ETASU FDA ETASU Frame et al., ETASU Frame et al., Oncology Nursing Society ONS REMS Haas, ONS REMS Stone, 2 REMS REMS NCCN ONS REMS REMS

7 Johnson et al., American Society of Clinical Oncology ASCO REMS, Frame et al.,, % REMS REMS ASCO REMS Frame et al., REMS REMS REMS NCCN REMS % REMS REMS REMS Johnson et al., REMS ONS NCCN ASCO REMS Frame et al., REMS ASCO ONS Jacobson et al., Jacobson et al., REMS Frame et al., Johnson et al., REMS Frame et al., 3 REMS / REMS FDA Blueprint Alford Safe and Competent Opioid Prescribing Education SCOPE, % advanced practice nurse % physician assistant % Alford et al., RMP COI J Nurs Studies NCNJ Vol. No.

8 Alford, D. P., Zisblatt, L., Ng, P., Hayes, S. M., Peloquin, S., Hardesty, I. et al.( ). SCOPE of pain: An evaluation of an opioid risk evaluation and mitigation strategy continuing education program. Pain Med, 17( ), -., ( ).., ( ), -., ( ). Risk management plan(rmp)., ( ), -. Frame, J. N., Jacobson, J. O., Vogel, W. H., Griffith, N., Wariabharaj, D., Garg, R. et al.( ). Assessment of risk evaluation and mitigation strategies in oncology: summary of the oncology risk evaluation and mitigation strategies workshop. J Oncol Pract, 9( ), e -. ( ).,, http //ganjoho.jp/data/reg_stat/statistics/ brochure/ /cancer_statistics_ _date_j.pdf Haas, M. L.( ). Oncology nurses at all levels need to know about REMS. ONS Connect, 25( ),.,,,, ( ).., ( ), -. ( ). EU,, http //www. pmda.go.jp/int-activities/int-harmony/.html Jacobson, J. O., Polovich, M., McNiff, K. K., Lefebvre, K. B., Cummings, C., Galioto, M. et al.( ). American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards. J Clin Oncol, 27( ), -. Jacobson, J. O., Polovich, M., Gilmore, T. R., Schulmeister, L., Esper, P., Lefebvre, K. B. et al.( ). Revisions to the American Society of Clinical Oncology/ Oncology Nursing Society chemotherapy administration safety standards: expanding the scope to include inpatient settings. J Oncol Pract, 8( ), -. Johnson, P. E., Dahlman, G., Eng, K., Garg, R., Gottlieb, S., Hoffman, J. M. et al.( ). NCCN oncology risk evaluation and mitigation strategies white paper: recommendations for stakeholders. J Natl Compr Canc Netw, 8 Suppl 7, S -S. ( )... No.,, http // go.jp/files/.pdf. Koyi, H., Hillerdal, G., Andersson, O., Kolbeck, K. G., Liv, P., Branden, E.( ). Chemotherapy treatment of elderly patients(>/= years) with non-small cell lung cancer: a seven-year retrospective study of real-life clinical practice at Karolinska university hospital, Sweden. Lung Cancer Int,. ( ). ( ) RMP( ). PHARM TECH JAPAN, ( ), -. ( ).,, http // / -.html ( ).,, http // / -.pdf ( ). v. JCOG,, http // Stone, A.( ). FDA remodels REMS for opioid medications. ONS Connect, 27( ),., ( ).., ( ), -. Risk Management Plan RMP RMP RMP RMP RMP

ICT 1 21 ICT., Cooper, Dawson

ICT 1 21 ICT., Cooper, Dawson - - - morin@adm.ncn.ac.jp Readiness and educational program for infection control link nurse Namiko Mori-YoshikawaMidori Nishioka National College of Nursing, Japan ; - - Umezono, Kiyose-shi, Tokyo, -,