Papers - Tsuchiya, Masami

Analysis of Overdose-related Posts on Social Media

Ryuya Sato, Masami Tsuchiya, Rintaro Ichiyama, Soma Hisamura, Satoshi Watabe, Yuki Yanagisawa, Tomohiro Nishiyama, Shuntaro Yada, Eiji Aramaki, Hayato Kizaki, Shungo Imai, Satoko Hori

YAKUGAKU ZASSHI (Pharmaceutical Society of Japan)  144 ( 12 ) 1125 - 1135 2024.12

Accepted,  ISSN  0031-6903

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Actual Status of Pharmacy Education Related to Adverse Drug Event Reports in Pharmacy Schools across Japan

Satoko Hori, Masami Tsuchiya, Hayato Kizaki, Masayuki Hashiguchi, Michihiro Satoh, Hirohito Metoki, Taku Obara, Nariyasu Mano

Japanese Journal of Drug Informatics 26 ( 3 ) 128 - 135 2024.12

Accepted

Exploring the factors associated with difficulties in extracting tablets or capsules from press‐through‐package sheets

Masami Tsuchiya, Shungo Imai, Masaki Asano, Yuri Shimizu, Hayato Kizaki, Yukiko Ito, Makoto Tsuchiya, Ryoko Kuriyama, Nao Yoshida, Masanori Shimada, Takanori Sando, Tomo Ishijima, Satoko Hori

British Journal of Clinical Pharmacology  2024.11

ISSN  0306-5251

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Post-marketing surveillance of anticancer drugs using natural language processing of electronic medical records

Yoshimasa Kawazoe, Kiminori Shimamoto, Tomohisa Seki, Masami Tsuchiya, Emiko Shinohara, Shuntaro Yada, Shoko Wakamiya, Shungo Imai, Satoko Hori, Eiji Aramaki

npj Digital Medicine (Springer Science and Business Media LLC)  7 ( 1 )  2024.11

Accepted,  ISSN  2398-6352

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Association Between Docetaxel-induced Hand-foot Syndrome and Patients’ Living Environment: A Case Series

Takashi UCHIDA, Masami TSUCHIYA, Katsuhisa HAYASHI, Tatsuro FUKUHARA, Yasuko MURAKAWA, Yoichiro KAKUGAWA, Kyoko INOOKA

Journal of Drug Interaction Research 48 ( 3 ) 44 - 53 2024.11

Accepted

Trend analysis of pharmacist involvement in cancer care in Japan from 2015 to 2020: A nationwide survey study on hospital pharmacy practice

Masami Tsuchiya, Daisuke Kikuchi, Shiro Hatakeyama, Yuichi Tasaka, Takeshi Uchikura, Ryohkan Funakoshi, Taku Obara

Journal of Oncology Pharmacy Practice (SAGE Publications)   2024.07

ISSN  1078-1552

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Introduction

Pharmacists are needed as members of oncology teams. The Japanese Society of Hospital Pharmacists (JSHP) conducts a nationwide survey annually to analyze the actual situation and generate fundamental information about hospital pharmacy practice in Japan. Using data from this large-scale survey, we described pharmacists’ involvement in cancer chemotherapy. We explored the factors related to the acceleration of pharmacists’ tasks or involvement in clinical practice, primarily in oncology.

Methods

Data were obtained from annual surveys conducted by JSHP from 2015 to 2020. All variables were expressed as categorical variables and tabulated. The Chi-square and Fisher's exact tests were used to compare the categorical variables. The Cochran–Armitage trend test was used to identify significant trends.

Results

From 2015 to 2020, 22,362 responses were recorded. After applying the exclusion criteria, 20,906 were analyzed. The proportion of hospitals enrolling pharmacists with oncology-related certifications significantly increased in all hospitals providing cancer care. Multivariable logistic regression analysis indicated that a smaller number of beds per pharmacist significantly correlated with additional fees for outpatient pharmacy services ( p = 0.0002 for trend).

Conclusion

Hospitals charging increased fees for outpatient oncology pharmacy services were associated with a smaller number of beds per pharmacist, regardless of hospital size. A balance between the number of beds and pharmacists, particularly certified oncology pharmacists, is crucial for safe and high-quality cancer treatment.

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External Validation and Update of the Risk Prediction Model for Denosumab-Induced Hypocalcemia Developed From a Hospital-Based Administrative Database.

Keisuke Ikegami, Shungo Imai, Osamu Yasumuro, Masami Tsuchiya, Naomi Henmi, Mariko Suzuki, Katsuhisa Hayashi, Chisato Miura, Haruna Abe, Hayato Kizaki, Ryohkan Funakoshi, Yasunori Sato, Satoko Hori

JCO clinical cancer informatics 8   e2400078 2024.07

ISSN  2473-4276

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PURPOSE: Denosumab is used to treat patients with bone metastasis from solid tumors, but sometimes causes severe hypocalcemia, so careful clinical management is important. This study aims to externally validate our previously developed risk prediction model for denosumab-induced hypocalcemia by using data from two facilities with different characteristics in Japan and to develop an updated model with improved performance and generalizability. METHODS: In the external validation, retrospective data of Kameda General Hospital (KGH) and Miyagi Cancer Center (MCC) between June 2013 and June 2022 were used and receiver operating characteristic (ROC)-AUC was mainly evaluated. A scoring-based updated model was developed using the same data set from a hospital-based administrative database as previously employed. Selection of variables related to prediction of hypocalcemia was based on the results of external validation. RESULTS: For the external validation, data from 235 KGH patients and 224 MCC patients were collected. ROC-AUC values in the original model were 0.879 and 0.774, respectively. The updated model consisting of clinical laboratory tests (calcium, albumin, and alkaline phosphatase) afforded similar ROC-AUC values in the two facilities (KGH, 0.837; MCC, 0.856). CONCLUSION: We developed an updated risk prediction model for denosumab-induced hypocalcemia with small interfacility differences. Our results indicate the importance of using data from plural facilities with different characteristics in the external validation of generalized prediction models and may be generally relevant to the clinical application of risk prediction models. Our findings are expected to contribute to improved management of bone metastasis treatment.

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Association Between Meteorological Elements and Hand-Foot Syndrome in Patients on Capecitabine-Containing Chemotherapy: An Observational Exploratory Study

Takashi Uchida, Masami Tsuchiya, Katsuhisa Hayashi, Gen Iwasashi, Kyoko Inooka

Japanese Journal of Pharmaceutical Health Care and Sciences 50 ( 6 ) 303 - 311 2024.06

Accepted

The emerging emetogenicity of trifluridine/tipiracil (TAS‑102) from patient self-reporting: a multicenter, prospective, observational study.

Hironori Fujii, Masami Tsuchiya, Daichi Watanabe, Ryo Otsuka, Daisuke Hirate, Katsuyuki Takahashi, Makiko Go, Toshihiro Kudo, Kazuhiro Shimomura, Yosuke Ando, Shinya Tani, Takao Takahashi, Katsuhisa Hayashi, Miki Chin, Naomi Matsunami, Masaya Takahashi, Akiko Hasegawa, Takashi Uchida, Hironobu Hashimoto, Akiko Kubo, Nobuhisa Matsuhashi, Akio Suzuki, Junichi Nishimura, Naoki Inui, Hirotoshi Iihara

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 32 ( 5 ) 291 - 291 2024.04

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BACKGROUND: Trifluridine/tipiracil (TAS-102) is an oral anticancer drug with adequate efficacy in unresectable colorectal cancer, but frequently also induces chemotherapy-induced nausea and vomiting (CINV). To investigate the occurrence of CINV and antiemetic therapy in patients with colorectal cancer treated with TAS-102 (JASCC-CINV 2001). METHODS: We conducted a multicenter, prospective, observational study in patients with colorectal cancer who received TAS-102 without dose reduction for the first time. Primary endpoint was the incidence of vomiting during the overall period. Secondary endpoints were the incidence of nausea, significant nausea, anorexia, other adverse events (constipation, diarrhea, insomnia, fatigue, dysgeusia) and patient satisfaction. Patient diaries were used for primary and secondary endpoints. All adverse events were subjectively assessed using PRO-CTCAE ver 1.0. and CTCAE ver 5.0. RESULTS: Data from 100 of the 119 enrolled patients were analyzed. The incidence of vomiting, nausea, and significant nausea was 13%, 67%, and 36%, respectively. The incidence of vomiting in patients with and without prophylactic antiemetic therapy were 20.8% and 10.5%, respectively. Prophylactic antiemetics were given to 24% of patients, of whom 70% received D2 antagonists. Multivariate Cox proportional hazards analysis showed that experience of CINV in previous treatment tended to be associated with vomiting (hazard ratio [HR]: 7.13, 95% confidence interval [CI]: 0.87-58.5, P = 0.07), whereas prophylactic antiemetic administration was not (HR: 1.61, 95 CI: 0.50-5.21, P = 0.43). With regard to patient satisfaction, the proportion of patients who were "very satisfied," "satisfied," "slightly satisfied" or "somewhat satisfied" was 81.8%. CONCLUSIONS: The low incidence of vomiting and high patient satisfaction suggest that TAS-102 does not require the use of uniform prophylactic antiemetic treatments. However, patients with the experience of CINV in previous treatment might require prophylactic antiemetic treatment.

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Proton Pump Inhibitors and Cyclin-Dependent Kinase 4/6 Inhibitors in Patients With Breast Cancer.

Kaori Takahashi, Ryuji Uozumi, Toru Mukohara, Tetsu Hayashida, Midori Iwabe, Hirotoshi Iihara, Kanako Kusuhara-Mamishin, Yuko Kitagawa, Masami Tsuchiya, Mika Kitahora, Aiko Nagayama, Shinkichi Kosaka, Yoshimi Asano-Niwa, Tomoko Seki, Koji Ohnuki, Akio Suzuki, Fumiko Ono, Manabu Futamura, Hitoshi Kawazoe, Tomonori Nakamura

The oncologist 29 ( 6 ) e741 - e749 2024.02

ISSN  1083-7159

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BACKGROUND: Proton pump inhibitors (PPIs) reduce the bioavailability of several anticancer drugs. The impact of PPIs co-administered with cyclin-dependent kinase 4 and 6 inhibitors is controversial. We aimed to clarify whether the concomitant use of PPIs impacts palbociclib and abemaciclib effectiveness in breast cancer treatment. PATIENTS AND METHODS: This multicenter, retrospective, observational study, conducted across 4 medical institutions in Japan, consecutively included patients with endocrine-resistant metastatic breast cancer, receiving palbociclib or abemaciclib between December 2017 and August 2022. Propensity score-matched analyses were performed. Treatment efficacy and safety with and without PPIs were compared. Progression-free survival and overall survival were estimated using the Kaplan-Meier method and compared using a log-rank test. A Cox proportional hazards model was used to estimate the hazard ratio. RESULTS: The study included 240 patients. After 1:1 matching, 112 patients were treated with and without PPIs. The median progression-free survival period was 1.2 years in the PPI group and 1.3 years in the non-PPI group (hazard ratio, 1.19; 95% CI, 0.70-2.02). The median overall survival period was 3.6 years in the PPI group, whereas it was not reached in the non-PPI group (hazard ratio, 1.23; 95% CI, 0.61-2.47). Consistent results were obtained for subgroups receiving palbociclib (n = 177) and abemaciclib (n = 63) without propensity score matching. Adverse event incidence and severity were similar in both groups. CONCLUSION: The effectiveness of cyclin-dependent kinase 4/6 inhibitors is unlikely to be affected by concomitant PPI use. Future prospective pharmacokinetic studies are warranted.

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添付文書で妊婦に対して禁忌に設定されている医薬品の特定と国際比較

酒井 隆全, 佐藤 ユリ, 畠山 史朗, 菊池 大輔, 土屋 雅美, 近藤 悠希, 佐藤 泉美, 岡田 裕子, 小原 拓

医薬品情報学 ((一社)日本医薬品情報学会)  25 ( 4 ) 211 - 219 2024.02

ISSN  1345-1464

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日本の添付文書で妊婦禁忌と記載された医薬品を特定し、海外における妊娠期の医薬品安全性分類と比較、評価した。2022年4月時点で薬価収載されている医療用医薬品19022医薬品のうち、妊娠禁忌の医薬品は4111医薬品(21.6%)であり、妊娠時期を限定せずに禁忌となっているものが9割以上を占めていた。薬効分類別では循環器用薬に次いでその他の代謝性医薬品が多く、the Australian categories for prescribing medicines in pregnancy(TGA分類)で禁忌に相当するXに分類された成分は16成分(4.3%)のみであった。医療関係者は添付文書における妊婦禁忌の留意点を適切に認識し、妊婦における医薬品の安全性情報を十分に評価した上で、使用可否について慎重に判断するべきであることが示唆された。

Evaluation of hospital pharmacists’ activities using additional reimbursement for infection prevention as an indicator in small and medium-sized hospitals

Yuichi Tasaka, Takeshi Uchikura, Shiro Hatakeyama, Daisuke Kikuchi, Masami Tsuchiya, Ryohkan Funakoshi, Taku Obara

Journal of Pharmaceutical Health Care and Sciences (Springer Science and Business Media LLC)  10 ( 1 ) 6 - 6 2024.01

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Abstract

Background

Hospitals in Japan established the healthcare delivery system from FY 2018 to 2021 by acquiring an additional reimbursement for infection prevention (ARIP) of category 1 or 2. However, research on outcomes of ARIP applications related to the practice of hospital pharmacists is scarce.

Methods

This study assessed the activities performed by hospital pharmacists in hospitals with 100 to 299 beds, using ARIP acquirement as an indicator, using data from an annual questionnaire survey conducted in 2020 by the Japanese Society of Hospital Pharmacists on the status of hospital pharmacy departments. Out of the survey items, this study used those related to hospital functions, number of beds, number of pharmacists, whether the hospital is included in the diagnosis procedure combination (DPC) system, average length of stay, and nature of work being performed in the analysis. The relationship between the number of beds per pharmacist and state of implementation of pharmacist services or the average length of hospital stay was considered uncorrelated when the absolute value of the correlation coefficient was within 0–0.2, whereas the relationship was considered to have a weak, moderate, or strong correlation when the absolute value ranged at 0.2–0.4, 0.4–0.7, or 0.7–1, respectively.

Results

Responses were received from 3612 (recovery rate: 43.6%) hospitals. Of these, 210 hospitals meeting the criteria for ARIP 1 with 100–299 beds, and 245 hospitals meeting the criteria for ARIP 2 with 100–299 beds, were included in our analysis. There was a significant difference in the number of pharmacists, with a larger number in ARIP 1 hospitals. For the pharmacist services, significant differences were observed, with a more frequency in ARIP 1 hospitals in pharmaceutical management and guidance to pre-hospitalization patients, sterile drug processing of injection drugs and therapeutic drug monitoring. In DPC hospitals with ARIP 1 (173 hospitals) and 2 (105 hospitals), the average number of beds per pharmacist was 21.7 and 24.7, respectively, while the average length of stay was 14.3 and 15.4 d, respectively. Additionally, a weak negative correlation was observed between the number of pharmacist services with “Fairly well” or “Often” and the number of beds per pharmacist for both ARIP 1 (R = -0.207) and ARIP 2 (R = -0.279) DPC hospitals. Furthermore, a weak correlation (R = 0.322) between the average number of beds per pharmacist and the average length of hospital stay was observed for ARIP 2 hospitals.

Conclusions

Our results suggest that lower beds per pharmacist might lead to improved pharmacist services in 100–299 beds DPC hospitals with ARIP 1 or 2. The promotion of proactive efforts in hospital pharmacist services and fewer beds per pharmacist may relate to shorter hospital stays especially in small and medium-sized hospitals with ARIP 2 when ARIP acquisition was used as an indicator. These findings may help to accelerate the involvement of hospital pharmacists in infection control in the future.

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Proposal for Classifying the Emetogenicity of Oral Anticancer Agents with a Focus on PARP Inhibitors: A Prospective, Observational, Multicenter Study (JASCC-CINV 2002)

Senri Yamamoto, Masami Tsuchiya, Hirotoshi Iihara, Yoh Hayasaki, Kyoko Hori, Yasuo Kumakura, Daichi Watanabe, Hideki Sakai, Satoshi Nakagawa, Akiko Kudoh, Hajime Oishi, Nobuhiro Kado, Makiko Go, Kota Mashima, Takashi Uchida, Moeka Yasue, Akimitsu Maeda, Kimihiro Nishino, Koji Matsumoto, Shinya Sato, Yutaka Ueda, Kensuke Tomio, Katsuhisa Hayashi, Motoki Takenaka, Masahiko Mori, Hiroaki Kajiyama, Yoshimasa Bomoto, Shiro Suzuki, Takuma Ishihara, Akio Suzuki, Masakazu Abe

Journal of Cancer (Ivyspring International Publisher)  15 ( 6 ) 1487 - 1497 2024.01

ISSN  1837-9664

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Survey on Attitudes toward Career Visions for Hospital Pharmacists

Hitoshi Kawazoe, Masami Tsuchiya, Maki Todo, Azusa Hara, Yumiko Ohnishi, Yoichi Osato, Satoko Hori

YAKUGAKU ZASSHI (Pharmaceutical Society of Japan)  143 ( 8 ) 683 - 691 2023.08

Lead author, Accepted,  ISSN  0031-6903

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Elucidating the Actual Utilization of Risk Management Plans (RMPs) in Hospital Pharmacy Departments

Daisuke Kikuchi, Masami Tsuchiya, Shiro Hatakeyama, Yuichi Tasaka, Takeshi Uchikura, Ryohkan Funakoshi, Taku Obara

Journal of Japanese Society of Hospital Pharmacists ((一社)日本病院薬剤師会)  59 ( 8 ) 833 - 839 2023.08

Accepted,  ISSN  1341-8815

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医薬品リスク管理計画(risk management plan:以下,RMP)は医薬品の適正使用推進とリスク最小化のために重要な情報である。本研究の目的は「平成30年度病院薬剤部門の現状調査」を用いて,RMPの利活用の実態を明らかにすることである。解析対象2,751施設のうちRMPを活用していたのは909施設(33.0%)であった。多変量解析の結果,病棟薬剤業務実施加算あり,患者の状態観察に基づく薬効・副作用の確認等にかなり取り組んでいる,医薬品の有効性・安全性情報の収集,管理および提供にかなり取り組んでいる,副作用等を一元管理している部門ありが,RMPの活用と正に関連しており,薬剤師1人当たりの病床数が多いことがRMPの活用と負に関連していた。本研究より,薬剤師1人当たりの病床数を低減させることによるファーマコビジランス業務の推進は,RMPの活用を介した医薬品安全使用に重要である。(著者抄録)

The prevalence of end-of-life chemotherapy and targeted therapy in Japan, assessed using a health claims database.

Masami Tsuchiya, Taku Obara, Masafumi Kikuchi, Nariyasu Mano

Cancer chemotherapy and pharmacology (Springer Science and Business Media LLC)  91 ( 6 ) 501 - 506 2023.05

ISSN  0344-5704

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PURPOSE: This study aimed to investigate the current status of end-of-life chemotherapy and targeted therapy and explore the aggressiveness of end-of-life care in Japan using the DeSC database, a large administrative claims database. METHODS: We identified fatal cases of at least one cancer-related diagnosis between April 2015 and November 2020. Patients prescribed at least one anticancer drug were analyzed, and chemotherapy regimens were categorized based on the combination of concomitant anticancer drugs prescribed. RESULTS: Among 1,095,713 individuals enrolled in the National Health Insurance database, 7,300 deaths with cancer-related diagnosis were identified. Of these, 4,010 cases were identified in which at least one anticancer drug was prescribed, and 11.6% of 7,300 death had been prescribed anticancer drugs in their last 30 days of life. The most commonly used regimen was S-1 (tegafur, gimeracil, and oteracil potassium combination) monotherapy, followed by nivolumab monotherapy and nab-paclitaxel plus gemcitabine. Immune checkpoint inhibitor monotherapy was more likely prescribed to patients whose last chemotherapy dose was in the last 30 days of life (p = 0.0066, chi-squared test). CONCLUSIONS: This study provides insights into the current status of end-of-life chemotherapy and targeted therapy in Japan, using a large administrative claims database. The results of this study will inform future research on end-of-life chemotherapy and targeted therapy, and help develop strategies to improve the quality of life of patients with advanced cancer.

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自由単語記載形式アンケートによるJASPOスタートアップ・ブラッシュアップセミナー2021セミナー内容に関する解析

寺薗 英之, 吉川 直樹, 小川 大介, 森 理保, 土屋 雅美, 牧 陽介, 板垣 文雄, 河原 陽介, 西村 佳子, 篠原 佳祐, 岩本 義弘, 益子 寛之, 米村 雅人, 内田 まや子

日本臨床腫瘍薬学会雑誌 ((一社)日本臨床腫瘍薬学会)  30   423 - 423 2023.05

Congenital dermatofibrosarcoma protuberans presenting as a depressed plaque: Clinical presentation and chronology

Nakajima, Y; Fusumae, T; Hirai, I; Nakamura, Y; Mori, T; Nakayama, R; Tsuchiya, M; Hashimoto, R; Funakoshi, T

JOURNAL OF DERMATOLOGY 50 ( 4 ) E127 - E128 2023.04

ISSN  0385-2407

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Birth Outcomes of Anticancer Drug Prescriptions during Pregnancy: A Case Series from a Japanese Claims Database

Kentaro Tajima, Tomofumi Ishikawa, Masami Tsuchiya, Masafumi Kikuchi, Taku Obara, Nariyasu Mano

Pharmacoepidemiology  2023.01

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Doublet or Triplet Antiemetic Prophylaxis for Nausea and Vomiting Induced by Trastuzumab Deruxtecan: an Open-Label, Randomized, and Multicenter Exploratory Phase 2 Study.

Hirotoshi Iihara, Mototsugu Shimokawa, Hiroko Bando, Yoshimi Niwa, Yutaka Mizuno, Yoshihiro Kawaguchi, Mika Kitahora, Akari Murakami, Masaaki Kawai, Kazushige Ishida, Makoto Takeuchi, Kazuhiro Ishihara, Tomokazu Iyoda, Takumi Nakada, Atsuko Ogiso, Yasuyuki Kojima, Fumiyoshi Kumagai, Aya Sawa, Ryutaro Mori, Kosuke Higuchi, Tomoko Furuta, Yoshiaki Kamei, Masami Tsuchiya, Azusa Terasaki, Senri Yamamoto, Mai Kitazawa, Mai Okazaki, Akio Suzuki, Manabu Futamura

Journal of Cancer 14 ( 14 ) 2644 - 2654 2023

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Background: Trastuzumab deruxtecan is classified as an anticancer agent that poses a moderate emetic risk in the international guidelines for antiemetic therapy. The guidelines recommend emesis prophylaxis using a two-drug combination therapy comprising a 5-hydroxytryptamine-3 receptor antagonist (5-HT3RA) and dexamethasone (DEX). However, the high incidence of nausea and vomiting associated with trastuzumab deruxtecan is problematic. The National Comprehensive Cancer Network guideline version 1.2023 classified trastuzumab deruxtecan as having a high risk of emesis and changed its recommendation to a triplet regimen including a neurokinin-1 receptor antagonist (NK1RA). However, the emetogenic potential of trastuzumab-deruxtecan and the optimal antiemetic prophylaxis are controversial. Hence, this exploratory phase 2 study aimed to assess the efficacy and safety of treatment comprising 5-HT3RA and DEX with or without a NK1RA in preventing trastuzumab deruxtecan-induced nausea and vomiting. Methods: We conducted an open-label and randomized exploratory phase 2 study at 14 centers in Japan. Patients with breast cancer who were scheduled to receive trastuzumab deruxtecan were enrolled in this study. The patients were randomly assigned to receive granisetron and DEX (arm GD) or granisetron, DEX, and aprepitant (fosaprepitant; arm GDA). The primary endpoint was complete response (CR; no emesis or no rescue therapy) during the overall phase (120 h after the start of trastuzumab deruxtecan). Results: Between September 2020 and March 2023, 40 patients were randomly assigned to the GD (n = 19) or GDA (n = 21) arm. In the GDA arm, one patient who did not complete the use of the rescue medication listed in the diary was excluded from the efficacy analysis, which included the use of rescue medication. The CR rates during the overall phase were 36.8% and 70.0% in the GD and GDA arms, respectively (odds ratio 0.1334; 95% confidence interval [CI]: 0.0232-0.7672; P = 0.0190), with a difference of 33.2%. No grade 3 or 4 toxicity related to antiemetic therapy was observed. Conclusions: Patients receiving trastuzumab deruxtecan require triple therapy, including mandatory NK1RA administration.

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