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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Actual status of patient information sharing among healthcare delivery facilities: a survey by the third subcommittee, committee on academic research, the Japanese society of hospital pharmacists.

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

Journal of pharmaceutical health care and sciences 8 ( 1 ) 30 - 30 2022.11

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BACKGROUND: Information sharing among medical professionals is important for providing quality medical care. The purpose of the present study was to elucidate the actual status of information sharing between hospitals and other healthcare delivery facilities by surveying information sharing among the pharmaceutical departments of Japanese hospitals in 2020 conducted by the Japanese Society of Hospital Pharmacists. METHODS: Responses were received from 3612 (43.6%) of the 8278 target medical institutions between May 2020 and August 2020. RESULTS: The proportions of hospitals that shared information with community pharmacies, other hospitals, and long-term nursing homes were 40.6%, 36.4%, and 27.3%, respectively. While tracing reports were the most common tool used by hospitals for information sharing with community pharmacies (54.3%), drug summaries were used for sharing information with other hospitals and long-term nursing homes (77.4% and 78.0%, respectively). The proportion of hospitals sharing information with community pharmacies and other hospitals showed a tendency to increase as the number of hospital beds increased. No relationship could be established between the number of hospital beds and the proportion of hospitals sharing information with long-term nursing homes. CONCLUSION: Information between hospitals and community pharmacies was shared primarily using tracing reports, whereas information between hospitals and other hospitals and long-term nursing homes was primarily shared via drug summaries.

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Using an online journal club to improve Asian speakers' comfort in using English to discuss and understand research papers written in English.

Masami Tsuchiya, Manit Saeteaw, Suphat Subongkot, Trai Tharnpanich, Jitprapa Konmun, Izumi Nasu, Yumiko Shimanuki, Toshiaki Tsuchitani, Mio Ezura, Koji Hashiguchi, Jeffrey C Bryan, Hitoshi Kawazoe

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners    10781552221107548 - 10781552221107548 2022.06

ISSN  1078-1552

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INTRODUCTION: This study aimed to evaluate the participants' comfort in understanding research papers written in English and discussing such research in English via an Asian online journal club. METHODS: A self-administered online survey was delivered to seven journal club meeting attendees from July 2020 to July 2021. A customer satisfaction analysis was performed to assess the association between the participants' perspectives on program logistics and satisfaction. RESULTS: The recovery rate was 37.0% (44/119). After participating in the journal club, the median scores of critical appraisal skills, knowledge and/or pharmaceutical care skills in clinical practice, and discussion skills in English (assessed using a seven-point Likert scale) improved significantly (compared to pre-participation median scores) from 4 (interquartile range [IQR]: 3-5) to 5 (IQR: 4-6), 5 (IQR: 4-5) to 5 (IQR: 5-6), and 4 (IQR: 2-5) to 5 (IQR: 3-5), respectively (P < 0.0001). The respondents also expressed great appreciation for the benefits and overall qualities of the journal club. Additionally, regarding patient care behavior after participation in the journal club, 34 (77.3%), 17 (38.6%), 16 (36.4%), and 14 (31.8%) respondents reported improvement in "drug information services," "patient assessments," "patient counseling," and "multidisciplinary rounds," respectively. Customer satisfaction analysis revealed that sharing information, mutual discussion, a shift system of presenters and co-chairs, and session duration should be improved as a matter of highest priority. CONCLUSION: The findings suggest that our program could be helpful for Asian pharmacists, pharmacy students, and faculty members of the department of pharmacy.

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Vonoprazan-associated nephrotoxicity: extensive real-world evidence from spontaneous adverse drug reaction reports

Masayuki Ishida, Masami Tsuchiya, Junko Naito, Hitoshi Kawazoe, Daichi Watanabe, Yujiro Nonaka, Mika Sano, Hiroyasu Sakai, Akio Suzuki, Keisuke Kumada, Hiroyuki Okura, Masahito Shimizu, Hirotoshi Iihara

Kidney International (Elsevier BV)  102 ( 3 ) 666 - 668 2022.06

ISSN  0085-2538

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多様な進路・働き方における薬剤師のキャリアパスに対する意識調査

土屋 雅美, 河添 仁, 大西 友美子, 島田 美樹, 堀 里子

医療薬学 ((一社)日本医療薬学会)  48 ( 6 ) 249 - 258 2022.06

ISSN  1346-342X

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第31回日本医療薬学会年会において開催された「薬剤師のキャリアパスに関するシンポジウム」を視聴した薬剤師65名を対象とし、職場環境やキャリアパスへの満足度に関する質問紙調査を行った。結果、職場におけるロールモデルの存在に関する満足度は全体的に低かった一方で、家族によるキャリアパス支援に関する満足度は比較的高い傾向が認められた。顧客満足度(CS)分析の手法を用い、キャリアパスに関して優先的に解決すべき課題について薬剤師はどのように考えているのか分析した結果、優先順位が最も高かったのは「教育研修体制」であり、次いで「ワーク・ライフバランス」、「研究活動」の順であった。シンポジウムの感想を自由記述してもらい、対応分析を行った結果、キャリア満足度が低い群に特徴的な語として[必要][視聴][大変][参考]などがあり、キャリア満足度が高い群に特徴的な語として[経験][研究][振り返る][現状][想像][上司][目標][違い][勉強]などがあった。

Itraconazole Contaminated with Rilmazafone in Japan: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database

Masami Tsuchiya, Taku Obara, Nariyasu Mano

Drugs - Real World Outcomes (Springer Science and Business Media {LLC})  9 ( 3 ) 315 - 319 2022.05

ISSN  2199-1154

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BACKGROUND: In early December 2020, the antifungal medication, itraconazole (ITCZ), was mistakenly contaminated with rilmazafone in Japan. Healthcare professionals reported adverse drug reaction reports associated with ITCZ and included central nervous system-depression symptoms such as dizziness, lightheadedness, loss of consciousness, and intense drowsiness. OBJECTIVE: We examined ITCZ-associated suspicious cases using the Japanese Adverse Drug Event Report (JADER) database to determine the impact of adverse drug reaction reporting on post-marketing safety measures. METHODS: Adverse drug reaction reports in which the suspicious or concomitant medication was ITCZ or fluconazole (FLCZ) were extracted from the JADER dataset. The number of adverse drug reaction reports associated with central nervous system-depression adverse drug reactions were counted, and chronological changes were compared with ITCZ and FLCZ. RESULTS: Of the 713,893 adverse drug reaction reports in the JADER database, 5048 cases were associated with ITCZ and 6007 cases with FLCZ. When ITCZ contamination occurred, the number of adverse drug reaction reports associated with ITCZ increased rapidly, while those with FLCZ did not. In addition, the proportion of central nervous system-depression adverse drug reactions increased only in the ITCZ-associated report. CONCLUSIONS: An incident of ITCZ contamination with rilmazafone was detected on the JADER retrospectively. This case highlights the importance of spontaneous adverse drug reaction reporting, even if the causal relationship between the drug and adverse drug reaction is unknown.

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Proton pump inhibitors affect capecitabine efficacy in patients with stage II-III colorectal cancer: a multicenter retrospective study.

Yoshiko Kitazume, Hitoshi Kawazoe, Ryuji Uozumi, Tomoe Yoshizawa, Hirotoshi Iihara, Hironori Fujii, Masaya Takahashi, Takahiro Arai, Yasushi Murachi, Yumiko Sato, Takahiro Mikami, Koji Hashiguchi, Tomoko Yamazaki, Katsuyuki Takahashi, Yukiyoshi Fujita, Yuki Hosokawa, Issei Morozumi, Masami Tsuchiya, Atsushi Yokoyama, Hironobu Hashimoto, Masakazu Yamaguchi

Scientific reports 12 ( 1 ) 6561 - 6561 2022.04

ISSN  2045-2322

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The association between capecitabine efficacy and proton pump inhibitors (PPIs) is controversial. Here, we determined whether co-administration of PPIs affects the real-world effectiveness of capecitabine. This retrospective observational study included consecutive patients with stage II-III colorectal cancer (CRC) who received adjuvant capecitabine monotherapy or CapeOX (capecitabine and oxaliplatin) between January 2009 and December 2014 at nine participating institutions. The primary endpoint was the difference in relapse-free survival (RFS) between patients who received PPIs and those who did not and was estimated using the Kaplan-Meier method. Overall survival (OS) was the secondary endpoint. Multivariable analysis of RFS and OS was performed using a Cox proportional hazards model, propensity score adjustment, and inverse probability of treatment weighting (IPTW) analyses. Data from 606 patients were evaluated, 54 of whom had received a PPI. PPI-treated patients tended to have poorer RFS and OS than patients treated without PPIs. The hazard ratio for RFS with capecitabine monotherapy was 2.48 (95% confidence interval: 1.22-5.07). These results were consistent with sensitivity analyses performed using propensity score adjustment and IPTW methods. Co-administration of PPIs may reduce the effectiveness of capecitabine and negatively impact patients with stage II-III CRC.

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Characteristics of hospitals that report adverse drug reactions: Results of a nationwide survey in Japan.

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

Journal of clinical pharmacy and therapeutics (Hindawi Limited)  47 ( 8 ) 1240 - 1248 2022.03

ISSN  0269-4727

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WHAT IS KNOWN AND OBJECTIVE: Adverse drug reactions (ADRs) are one of the primary reasons for hospitalization. The spontaneous reporting of ADRs by healthcare professionals is important for issuing post-marketing drug safety measures. The Japanese Society of Hospital Pharmacists (JSHP) conducts a nationwide survey annually. Using data from this large-scale survey, we identified the characteristics of hospitals that reported ADRs to regulatory authorities and pharmaceutical companies. 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 test was used to compare the categorical variables. The Cochran-Armitage trend test was used to identify significant trends in the proportion of hospitals reporting ADRs. RESULTS AND DISCUSSION: From 2015 to 2020, 22,362 responses were recorded. There was a significant increase in the proportion of hospitals that reported ADRs with an increase in number of beds and pharmacists (p < 0.0001). The proportion of hospitals reporting ADRs to regulatory authorities was also significantly higher in those charging an additional fee for pharmacist-performed ward operations and in those with an ADR data management section than in hospitals without these attributes (p < 0.0001). WHAT IS NEW AND CONCLUSION: Hospitals that submitted ADR reports to the regulatory authorities and pharmaceutical companies charged an additional fee for pharmacist-performed ward operations, had a central ADR data management section, and had fewer beds per pharmacist. This trend was similar, regardless of the size of the hospital.

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Grain-size-insensitive dielectric properties of Sr_0.6Ba_0.4Nb₂O₆ relaxor ferroelectric ceramics with tetragonal tungsten bronze structure

Tsuchiya, M; Fujihara, S; Hagiwara, M

CERAMICS INTERNATIONAL 48 ( 5 ) 6819 - 6825 2022.03

ISSN  0272-8842

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Evaluation of a Webinar for Pharmacists Learning Basic Clinical-Oncology during COVID-19 Pandemic in Japan.

Hideyuki Terazono, Masami Tsuchiya, Yosuke Maki, Naoki Yoshikawa, Yosuke Kawahara, Keiko Nishimura, Keisuke Shinohara, Daisuke Ogawa, Riho Mori, Yoshihiro Iwamoto, Fumio Itagaki, Hiroyuki Masuko, Masahito Yonemura, Mayako Uchida

Biological & pharmaceutical bulletin 45 ( 7 ) 856 - 862 2022

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It is essential for oncology pharmacists to update their knowledge, skills, and ethical attitudes. The Japanese Society of Pharmaceutical Oncology is an academic society for healthcare professionals involved in cancer treatment. It has conducted in-person seminars every year to cultivate the knowledge necessary for practicing advanced cancer medicine. Owing to the coronavirus disease (COVID-19) pandemic, the society was obligated to conduct a web-based seminar this year. A questionnaire survey was conducted before and after the webinar to explain how it works and to assess the learning attitudes of beginner and moderately skilled pharmacists in the field of oncology. Questionnaire surveys were conducted with the participants before and after watching the webinar. The questionnaires sought to determine participants' perspectives on the webinar and their knowledge of the seven modules. Of the 1756 webinar attendees, 1661 (94.6%) answered the pre-webinar survey and 1586 (90.3%) answered the post-webinar survey. Results indicate that the median post-webinar knowledge score was significantly higher than the median pre-webinar score (p < 0.001) in all modules. Principal component analysis of the degree of knowledge of seven modules revealed that the improved score group consisted of those from younger age groups, with less experience as pharmacists, non-society members, and those with less experience in past society seminars. Moreover, the web-based seminar provided a uniform learning effect throughout the country without distinguishing between urban and rural learners. The web-based educational program was an acceptable educational tool for Japanese oncology pharmacists.

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Association between the Co-administration of Histamine H2 Receptor Antagonists and the Effectiveness of Capecitabine in Patients with Colorectal Cancer: Propensity Score Analysis.

Tomoko Yamazaki, Ryuji Uozumi, Hitoshi Kawazoe, Yoshiko Kitazume, Hirotoshi Iihara, Hironori Fujii, Masaya Takahashi, Takahiro Arai, Yasushi Murachi, Yumiko Sato, Takahiro Mikami, Koji Hashiguchi, Tomoe Yoshizawa, Katsuyuki Takahashi, Yukiyoshi Fujita, Yuki Hosokawa, Issei Morozumi, Masami Tsuchiya, Atsushi Yokoyama, Hironobu Hashimoto, Tetsuya Furukawa

Journal of Cancer 13 ( 10 ) 3073 - 3083 2022

ISSN  1837-9664

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Background: The association between the effectiveness of capecitabine and the concomitant administration of gastric acid suppressants remains controversial. We aimed to clarify whether the effectiveness of capecitabine is affected by the co-administration of histamine H2 receptor antagonists (H2RAs) in early-stage colorectal cancer (CRC) patients using real-world data. Methods: This multicenter, retrospective, observational study included consecutive patients with stage II-III CRC who received either capecitabine monotherapy or the CapeOX regimen (capecitabine and oxaliplatin) as adjuvant therapy between January 2009 and December 2014 in Japan. Relapse-free survival (RFS) and overall survival were estimated using the Kaplan-Meier method. Additionally, multivariable Cox proportional hazards model, propensity score adjustment, and inverse probability of treatment weighting analyses were performed. Results: In total, 552 patients were included in this study, of which 30 were co-administered H2RAs. RFS at five years was 76.7% (95% confidence interval [CI]: 57.2-88.1%) and 79.8% (95% CI: 76.0-83.0%) in the H2RA and non-H2RA groups, respectively. Multivariable Cox proportional hazards model and propensity score-adjusted analyses showed that the co-administration of H2RAs was associated with a poor RFS among those receiving capecitabine monotherapy (hazard ratio [HR], 2.01; 95% CI: 0.86-4.70 and HR, 1.81; 95% CI: 0.77-4.22, respectively). In contrast, these results were inconsistent with the group receiving the CapeOX regimen. Conclusions: The study findings suggest that the co-administration of H2RAs may not reduce the effectiveness of capecitabine therapy in patients with early-stage CRC. To confirm this relationship, a prospective study with a pharmacokinetic approach is needed.

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ドセタキセル投与患者の手に発現した皮膚障害と外的環境との関連

内田 敬, 土屋 雅美, 林 克剛, 猪岡 京子, 西條 嘉代子

日本臨床腫瘍薬学会雑誌 ((一社)日本臨床腫瘍薬学会)  22   1 - 7 2021.10

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ドセタキセル(以下DTX)による皮膚障害は、患者のQOLの低下をもたらす。今回、DTX投与患者の手に発現した皮膚障害について、外的環境との関連を後方視的に調査した。当院にて、2013/1-2015/4の期間にDTXを含む周術期化学療法(DTX 75mg/m2、3週毎、4コース)を開始した女性の乳癌患者を調査対象とし、手における皮膚障害発現群と非発現群で、化学療法施行期間中の平均気温および平均水蒸気圧を比較した。対象患者63名中、手に皮膚障害が発現したのは9名(14.3%)であった。多変量解析の結果、化学療法施行期間中の平均気温≦13.4℃であることが、手における皮膚障害の発現と独立して有意に関連していた(オッズ比:10.6, 95% 信頼区間:1.2-92.5)。DTXを投与中の乳癌患者において、化学療法施行期間中の平均気温と手における皮膚障害の発現との関連が示唆された。(著者抄録)

Evaluation of a web-based educational programme for pharmacists during the COVID-19 pandemic in Japan.

Masami Tsuchiya, Hideyuki Terazono, Yosuke Maki, Naoki Yoshikawa, Yosuke Kawahara, Keiko Nishimura, Keisuke Shinohara, Daisuke Ogawa, Riho Mori, Yoshihiro Iwamoto, Fumio Itagaki, Hiroyuki Masuko, Masahito Yonemura, Mayako Uchida

Journal of clinical pharmacy and therapeutics (Hindawi Limited)  46 ( 6 ) 1743 - 1749 2021.09

ISSN  0269-4727

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WHAT IS KNOWN AND OBJECTIVE: Continuing education is essential for pharmacists to acquire and maintain the knowledge, skills, and ethical attitudes necessary for clinical practice. However, with the emergence of COVID-19, the social circumstances and face-to-face learning environments have changed. The objectives of this study were to determine Japanese pharmacists' perception of a web-based educational programme in oncology, and assess changes in their understanding of pharmaceutical care in oncology before and after their participation in the webinar. METHODS: Questionnaire-based surveys were conducted for the participants of the web-based educational programme to determine their perspectives on the webinar, and their degree of comprehension of the five cancer types covered before and after watching the webinar. RESULTS AND DISCUSSION: Of the 1936 pharmacists taking the programme, all participated in the pre-webinar survey, and 1861 (96.1%) in the post-webinar survey. Compared with previous seminars that were held in the offline mode before the COVID-19 pandemic, 76.8% of respondents were significantly satisfied with the web-based educational programme. The median post-webinar comprehension scores in all modules were significantly higher than the median pre-webinar scores (p < 0.0001). A majority of the participants agreed that a web-based educational programme was satisfactory in acquiring knowledge. WHAT IS NEW AND CONCLUSION: This web-based educational programme was effective for Japanese pharmacists for postgraduate education in pharmaceutical care in oncology. To the best of our knowledge, our study is the first to report the effectiveness of a web-based educational programme for oncology pharmacists using a large population.

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High-quality reports and their characteristics in the Japanese Adverse Drug Event Report database (JADER)

Masami Tsuchiya, Taku Obara, Makoto Miyazaki, Aoi Noda, Takamasa Sakai, Ryohkan Funakoshi, Nariyasu Mano

JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES (CANADIAN SOC PHARMACEUTICAL SCIENCES)  24   161 - 173 2021.04

ISSN  1482-1826

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Purpose: Spontaneous adverse drug reaction reporting is the foundation of postmarketing drug safety monitoring. The present study aimed to analyze and clarify the quality and characteristics of the Japanese Adverse Drug Event Report database (JADER) using the World Health Organization (WHO) documentation grading scheme and the vigiGrade completeness score. The characteristics of reports were described using both schemes simultaneously. The way of proper use of these two schemes was explored. Methods: The WHO documentation grading scheme and the vigiGrade completeness score were applied to the same dataset (JADER202001 dataset). Reports classified as high-quality under both assessment criteria were extracted, and the characteristics of these reports were analyzed. Results: Of the 607,361 adverse drug reaction reports analyzed, 52.8% were 'well-documented reports' with a vigiGrade completeness score >0.8. Under the WHO documentation grading scheme, 328,702 reports (54.1%) were Grade 2 and 5,178 (0.9%) were Grade 3 (including rechallenge information). Among well-documented Grade 3 reports, classified as the highest quality, a high proportion of the adverse drug reaction reports were related to disorders of hematopoietic function resulting from anticancer drugs. Because a high proportion of the reports with rechallenge information were for anticancer drugs as suspect drugs, the WHO documentation grading scheme tended to extract reports regarding anticancer drugs as high quality. Conclusions: We conclude that the two schemes need to be used appropriately, depending on the purpose of analysis, the target adverse drug reactions, and suspect drugs.

Implementation of an Adverse Drug Reaction Monitoring System Based on Risk Management Plans

Tsuchiya Masami, Esashi Akihisa, Obara Taku, Funakoshi Ryohkan, Mano Nariyasu

医薬品相互作用研究 ((一社)医薬品相互作用研究会)  45 ( 1 ) 19 - 26 2021.03

ISSN  0385-5015

Real-world anticancer medications for reproductive-age women with breast cancer by using a claims database in Japan.

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

Future oncology (London, England) (Future Medicine Ltd)  17 ( 15 ) 1907 - 1921 2021.02

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Aim: To describe real-world breast cancer medications among reproductive-age women. Patients & methods: Using data from a Japanese claims database, anticancer prescriptions were classified into seven categories of amenorrhea risk based on fertility preservation guidelines. Results: We identified 2999 women with records of breast cancer and anticancer prescription from 2005 to 2018. The proportions of prescriptions were as follows: high, 4.1-12.9%; intermediate, 6.0-16.3%; low, 0.4-2.3%; very low/no, 0.3-12.2%; unknown, 33.9-45.5%; unlisted combination, 12.2-23.4%; and unlisted drug, 12.5-26.7%. The common drugs in the unknown category were trastuzumab (n = 1527), docetaxel (n = 1014), and paclitaxel (n = 995). For medications unlisted in the guidelines, various drugs and drug combinations were observed. Conclusion: Numerous anticancer drugs are currently being prescribed with insufficient evidence regarding amenorrhea risk.

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Knowledge, Attitudes, and Practice of Hospital Pharmacists Regarding Pharmacovigilance and Adverse Drug Reaction Reporting in Japan

Tomonori Kobayashi, Aoi Noda, Taku Obara, Masami Tsuchiya, Kazutoshi Akasaka, Makiko Yoshida, Masaki Matsuura, Mayumi Sato, Yuriko Murai, Hiroaki Yamaguchi, Fumito Tsuchiya, Kenji Kihira, Nariyasu Mano

HOSPITAL PHARMACY (SAGE PUBLICATIONS INC)  56 ( 1 ) 7 - 16 2021.02

Accepted,  ISSN  0018-5787

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Background: The importance of pharmacovigilance in Japan is gradually being recognized. However, Japanese pharmacists' knowledge of and perspectives on pharmacovigilance have been examined only in some areas of Japan. Objective: The objective of this study was to clarify the knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting among hospital pharmacists in Japan. Setting: A questionnaire survey among Japanese hospital pharmacists. Method: The questionnaire was distributed to 48 028 pharmacists during a 3-month period between January and March 2017. Main Outcome Measure: The prevalence of hospital pharmacists who understood pharmacovigilance and the ADR reporting system. Results: Of the respondents (response rate; 9.9% = 4760/48 028), 21.9% were <30 years of age, 27.3% were >= 50 years of age, and 46.7% were women. In response to the question "Have you ever heard of the term 'pharmacovigilance'?," 12.4%, 33.8%, and 47.4% answered "I understand what it is," "I have heard of it, but I do not understand what it is," and "I do not know what it is," respectively. Pharmacists who understood the term "pharmacovigilance" were also more frequently acquainted with its associated terms and actions. And, 69.7% of respondents wished to acquire more information on pharmacovigilance and 50.9% did not have a personal history of ADR reporting. The most common reason for ADR nonreporting was "It was a well-known adverse drug reaction" (44.5%). Conclusions: Our results suggest that more aggressive promotion of pharmacovigilance and of the ADR reporting system among Japanese pharmacists is needed.

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Adverse Drug Reaction Reports Regarding Abnormal Behavior After Oseltamivir Use in Children as Reported by Consumers or Healthcare Professionals.

Aoi Noda, Masami Tsuchiya, Takamasa Sakai, Taku Obara, Nariyasu Mano

Patient preference and adherence 15   533 - 541 2021

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Purpose: The purpose of this study was to assess the differences between consumer (patient) and healthcare professional submissions of adverse drug reaction (ADR) reports associated with certain antiviral treatments in children. Material and Methods: We extracted ADR reports for children aged <20 years who received oseltamivir or similar drugs (zanamivir and amantadine) between April 2004 and May 2020 from the Japanese Adverse Drug Event Report database. Abnormal behavior after oseltamivir administration was reported frequently in the news in November 2005, and a Dear Healthcare Professional letter about abnormal behavior after oseltamivir use was issued on March 20, 2007. We compared the number of ADR reports by three periods: (1) before the news, (2) between the news and the letter, and (3) after the letter. These reports were tabulated and analyzed after stratification according to the reporter (healthcare professionals only, patients and healthcare professionals, patients only), patient age (<10 years, 10-19 years), and ADR (abnormal behavior, other ADRs). Results: For the reports from healthcare professionals only, the number of reports per quarter associated with oseltamivir was largest during the period between the news about abnormal behavior after oseltamivir use and publication of the Dear Healthcare Professional letter. The reports from patients only about abnormal behavior after oseltamivir use were first reported after publication of the letter. The proportions of reports from patients only about abnormal behavior with oseltamivir were 81.0% and 92.2% for ages <10 and 10-19 years, respectively. A ripple effect of increasing reports was observed with zanamivir or amantadine. Conclusion: Reports from patients only might increase in response to the media more than reports from healthcare professionals only or patients and healthcare professionals do. The ADR reports from patients must be carefully assessed from the perspective of when they were reported.

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Evaluation of the Outcome of the International Journal Club for Healthcare Professionals and Students

土屋雅美, 河添仁, 江面美緒, 橋口宏司, 飯原大稔, 橋本浩伸

医療薬学 ((一社)日本医療薬学会)  46 ( 11 ) 664 - 671 2020.11

ISSN  1346-342X

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2019年から2020年にかけて著者らが開催した国内外の医療従事者および医療系学生を対象としたジャーナルクラブのアウトカムについて検証した。医療従事者および医療系学生延べ142名を対象とした。質問紙調査の回答は53名中33名から得られ、薬剤師18名(54.6%)、医療系学生4名(12.1%)、医師4名(12.1%)の順に多く、居住国は日本が25名(75.8%)、日本以外のアジア諸国(タイ、韓国、台湾)が7名(21.2%)、米国が1名(3.0%)であった。ジャーナルクラブ参加前後での論文の批判的吟味に関する能力の自己評価、英語で議論する能力に関する自己評価、エビデンスに基づき実臨床を行う能力に関する自己評価および議論中の発言のしやすさはいずれも参加後において有意にスコアが改善していた。本ジャーナルクラブは、国際化が進む医療現場でがんの多職種チーム医療を円滑に遂行するために有用であると考えられた。

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database.

Aoi Noda, Takamasa Sakai, Masami Tsuchiya, Gen Oyanagi, Taku Obara, Nariyasu Mano

Vaccines 8 ( 3 )  2020.07

Accepted

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The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10-19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of "death" and "did not recover" as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10-19 years, respectively. The most frequently reported vaccine-reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10-19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.

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Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database.

Aoi Noda, Takamasa Sakai, Taku Obara, Makoto Miyazaki, Masami Tsuchiya, Gen Oyanagi, Yuriko Murai, Nariyasu Mano

BMC pharmacology & toxicology 21 ( 1 ) 36 - 36 2020.05

Accepted

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BACKGROUND: There are no reports on investigations of the characteristics of adverse drug reaction (ADR) reports for pediatric patients in the Japanese Adverse Drug Event Report database (JADER) and the utility of database for drug safety surveillance in these patients. METHOD: We aimed to evaluate ADR reports for pediatric patients in the JADER. We used spontaneous ADR reports included in the JADER since April 1, 2004, to December 31, 2017, which was downloaded in April 2018. In a total of 504,407 ADR reports, the number of spontaneous reports was 386,400 (76.6%), in which 37,534 (7.4%) were unknown age reports. After extraction of 27,800 ADR reports for children aged < 10 and 10-19 years, we excepted for ADR reports associated with a vaccine (n = 6355) and no-suspected drug reports (n = 86). A total of 21,359 (4.2%) reports were finally included in this analysis. RESULTS: More than half of the ADR reports were for children aged < 10 years. Approximately 30% of ADR reports had multiple suspected drugs, which did not differ by age. The percentages of fatal outcomes of ADRs among patients aged < 10 and 10-19 years were 4.7 and 3.9%, respectively. The most frequently reported drug, reaction, and drug-reaction pair were oseltamivir, abnormal behavior, and oseltamivir and abnormal behavior, respectively. CONCLUSION: We clarified the characteristics of ADR reports for Japanese children by using the JADER. ADR report databases, especially those for pediatric patients, are valuable pharmacovigilance tools in Japan and other countries. Therefore, a proper understanding of the characteristics of the ADR reports in the JADER is important. Additionally, potential signals for ADRs in pediatric patients should be monitored continuously and carefully.

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The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade

Masami Tsuchiya, Taku Obara, Makoto Miyazaki, Aoi Noda, Chizuko Takamura, Nariyasu Mano

International Journal of Clinical Pharmacy 42 ( 2 ) 728 - 736 2020.04

Accepted,  ISSN  2210-7703

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© 2020, Springer Nature Switzerland AG. Background The quality of adverse drug reaction reports can have a strong influence on the causality assessment or the detection of safety signals. Various methods have been used to evaluate the quality of adverse drug reaction reports. Objective We used the vigiGrade completeness score to evaluate the quality of the Japanese adverse drug event report database (JADER). Methods Among all reports in the JADER (cases received by regulatory authorities from April 2004 to November 2018), 427,797 cases that did not meet the exclusion criteria were analyzed using vigiGrade. An report was considered a ‘well-documented’ report if the completeness score > 0.8. For each dimension, the proportion of incomplete information was calculated. Main outcome measure Proportion of ‘well-documented’ reports. Results A total of 211,774 (49.5%) cases were classified as ‘well-documented’ reports. When classified by sender, 6240 out of 8257 cases (75.6%) from medical institutions were ‘well-documented’, while 205,534 out of 419,540 cases (49.0%) from pharmaceutical companies were categorized as such. ‘Time-to-onset’ could not be calculated in 173,027 (41.2%) cases from the pharmaceutical companies and in 1228 (14.9%) cases from medical institutions. Conclusion In the JADER, the proportion of ‘well-documented’ adverse drug reaction reports from medical institutions was higher than that from pharmaceutical companies, and reports from medical institutions could help to clarify generated safety signals. We also found that more than 40% of the reports from pharmaceutical companies did not include information that is considered essential for the evaluation of any causal relationship between suspected drugs and adverse drug reactions, which could pose challenges to the detection of safety signals.

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Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Masami Tsuchiya, Taku Obara, Takamasa Sakai, Kaori Nomura, Chizuko Takamura, Nariyasu Mano

Pharmacoepidemiology and Drug Safety 29 ( 2 ) 173 - 181 2020.02

Accepted,  ISSN  1053-8569

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© 2019 John Wiley & Sons, Ltd. Introduction: The spontaneous adverse drug reaction (ADR) reporting system plays an important role in pharmacovigilance by providing information from clinical settings in the postmarketing environment. The Japanese Adverse Drug Event Report (JADER) database contains a portion of Japanese ADR reports, and no previous study has described the quality or characteristics of ADR reports in the JADER. Objective: The aim of this study was to identify the characteristics of the JADER database and to evaluate the quality of ADR reports contained in the JADER using the documentation-grading scheme developed by the World Health Organization. Methods: Of 478 508 ADR reports in the JADER, the analysis set consisted of 395 091 reports meeting inclusion criteria. An analysis was carried out to evaluate the quality of the reports according to the type of report, the type of sender, and the qualification of the reporter. Annual changes in the number of reports from medical institutions submitted by pharmacists were compared with changes in the number submitted by physicians. Results: The distribution of documentation grade differed according to the type of report, the type of sender, and the qualification of the reporter. Regarding “medical institution reports”, the quality of reports was similar among qualification types, while the quality of reports submitted by physicians was higher for “company reports” and “study reports” (P <.0001, respectively). Conclusion: Our study showed that the quality of the ADR reports in the JADER differed among the type of report, the sender of the report, and the qualification of the reporter.

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Effect of Educational Interventions on Adverse Drug Reaction Reporting in a Cancer Institute in Japan: A Questionnaire Study

Masami Tsuchiya, Akihisa Esashi, Taku Obara, Kyoko Inooka, Nariyasu Mano, Chizuko Takamura

Hospital Pharmacy 54 ( 2 ) 93 - 99 2019.04

Accepted,  ISSN  0018-5787

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© The Author(s) 2018. Background: Limited data regarding knowledge and factors related to understanding the adverse drug reaction (ADR) reporting system of health care professionals are available in Japan. Objective: The objective of this study was to identify factors related to understanding the ADR reporting system in Miyagi Cancer Center and to find ways to increase the number and quality of ADR reports. Methods: Self-administered questionnaire surveys were administered before and after the educational meeting among health care professionals who were working in our hospital during the study period. Subanalyses restricted to nurses were also performed. Main Outcome Measure: Understanding ADR reporting system among healthcare professionals. Results: The percentage of respondents who understood the ADR reporting system in the questionnaire after the educational meeting was significantly higher than that in the questionnaire before the educational meeting. In the questionnaire after the educational meeting, multivariate logistic regression analysis found that having over 30 years of practical experience (odds ratio [OR], 3.852; 95% confidence interval [CI], 1.228-12.081 for 20-29 years, 7.695; 1.650-35.881 for over 30 years), being a physician (8.071; 1.923-33.878), being a pharmacist (18.357; 3.847-87.585), and participating in the educational meeting (5.111; 1.700-15.365) were factors associated with understanding the ADR reporting system. Multivariate logistic regression analysis of the questionnaire results before the educational meeting among nurses showed that working at outpatient departments (8.330; 3.008-23.069) was significantly and independently associated with understanding the ADR reporting system. Conclusions: The present study demonstrated that many years of practical experience, profession (physicians, pharmacists), and educational interventions were associated with good understanding of the ADR reporting system among health care professionals.

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Management of Cutaneous Adverse Events Induced by Anticancer Drugs

土屋雅美

医薬品相互作用研究 (医薬品相互作用研究会)  43 ( 3 ) 167 - 178 2019

ISSN  0385-5015

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抗癌薬による皮膚障害のうち、主に固形癌の治療において汎用されるタキサン系抗癌薬による爪障害、フッ化ピリミジン系薬による手足症候群、抗EGFR抗体薬による皮膚障害について、その概論および予防・治療方法を解説した。次いで、宮城県立がんセンターにおける皮膚障害対策として、皮膚症状ケアハンドブックの作成、薬剤師外来での取り組みを紹介した。

Antiproteinuric effects of renin-angiotensin inhibitors in lung cancer patients receiving bevacizumab

Satoru Nihei, Junya Sato, Toshiyuki Harada, Shoichi Kuyama, Toshiro Suzuki, Nobutsugu Waga, Yoshitaka Saito, Shigeki Kisara, Atsuko Yokota, Kouji Okada, Masami Tsuchiya, Kazufumi Terui, Yumiko Tadokoro, Takeshi Chiba, Kenzo Kudo, Satoshi Oizumi, Akira Inoue, Naoto Morikawa

CANCER CHEMOTHERAPY AND PHARMACOLOGY (SPRINGER)  81 ( 6 ) 1051 - 1059 2018.06

Accepted,  ISSN  0344-5704

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The objective of this study was to investigate the effect of renin-angiotensin system inhibitors (RASIs) on bevacizumab (BV)-induced proteinuria in non-small cell lung cancer (NSCLC) patients.We retrospectively reviewed the medical records of NSCLC patients receiving BV between 2008 and 2014 at 11 hospitals. The patients were categorized into three groups according to their antihypertensive drug use: RASI user, non-RASI user, and non-user groups. The primary outcome was a proteinuria event of any grade during the first 6 cycles of BV treatment.A total of 211 patients were included, 89 of whom received antihypertensive drugs. Of these 89 patients, 49 were in the RASI user group, and 40 were in the non-RASI user group. The non-user group comprised 122 patients. The occurrence of proteinuria in the RASI user group was significantly lower than that in the non-RASI user group (P = 0.037) but was not significantly lower than that in the non-user group (P = 0.287). Patients using RASIs had a lower rate of proteinuria than those who did not use RASIs according to multivariate analysis (odds ratio 0.32; 95% confidence interval 0.12-0.86; P = 0.024).Our study suggests that RASI administration reduces the risk of proteinuria in patients receiving BV.

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Evaluation of the Educational Effects of Training for Safe Handling of Hazardous Drugs by Measurement of Hazardous Drug Residue

土屋雅美, 浦山雄介, 江刺晶央, 高村千津子

医薬品相互作用研究 (医薬品相互作用研究会)  42 ( 3 ) 178 - 182 2018

ISSN  0385-5015

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抗がん薬による職業的曝露と環境汚染低減のため、薬剤師に対して化学発光液を用いた抗がん薬の取扱いに関するトレーニングを行い、その前後に作業者の手袋の残留抗がん薬量を測定した。研究対象者5名が化学発光液を用いたトレーニングを行い、5名全員について薬液入りバイアルのゴム栓、輸液ボトルのゴム栓部への化学発光液の付着が確認された。1時間のトレーニング実施後には、すべての被験者で化学発光液の落下や付着が認められなくなった。トレーニング前後における手袋の残留抗がん薬量に関して、5-フルオロウラシルはトレーニング実施前では5名中3名で検出されたのに対し、トレーニング実施後では5名中5名が検出限界以下であった。ゲムシタビン塩酸塩はトレーニング前後でそれぞれ5名中1名から検出され、同一の研究対象者であった。手袋に付着した抗がん薬量の測定は、トレーニング方法の評価指標として適用可能であることが示唆された。

A retrospective analysis of the risk factors for emetic events or usage of anti-emetic agents induced by TC (paclitaxel/carboplatin) therapy in patients with gynecologic cancer

土屋雅美, 小原拓, 猪岡京子, 高村千津子

日本臨床腫瘍薬学会雑誌(Web) ((一社)日本臨床腫瘍薬学会)  5   1 - 6 2016.12

ISSN  2189-129X

QOL 非小細胞肺癌におけるBevacizumab誘発蛋白尿に対するRAS阻害薬の有効性に関する多施設共同研究 NJLCG1303

土屋 雅美, 二瓶 哲, 佐藤 淳也, 久山 彰一, 鈴木 俊郎, 斎藤 佳敬, 木皿 重樹, 岡田 浩司, 原田 敏之, 横田 敦子, 照井 一史, 宮浦 誠治, 田所 佑実子, 前門戸 任, 森川 直人

肺癌 ((NPO)日本肺癌学会)  55 ( 5 ) 395 - 395 2015.10

Accepted,  ISSN  0386-9628

RAS Inhibitor Prevent Proteinuria of NSCLC Patients Who Received Bevasizumab Chemotherapy: NJLCG 1303

Shoichi Kuyama, Satoru Nihei, Toshiyuki Harada, Toshiro Suzuki, Yoshitaka Saito, Satoshi Oizumi, Shigeki Kisara, Akira Inoue, Atsuko Yokota, Hiroshi Yokouchi, Koji Okada, Yoshiaki Mori, Masami Tsuchiya, Makoto Maemondo, Kazufumi Terui, Kageaki Taima, Yumiko Tadokoro, Hiroshi Watanabe, Junya Sato, Naoto Morikawa

JOURNAL OF THORACIC ONCOLOGY (ELSEVIER SCIENCE INC)  10 ( 9 ) S662 - S662 2015.09

ISSN  1556-0864

An accurate quantitative HPLC-UV method for determination of sorafenib and sorafenib N-oxide in human serum

Shimada M, Okawa H, Maejima T, Yanagi T, Hisamichi K, Matsuura M, Akasaka K, Tsuchiya M, Kondo Y, Shimosegawa T, Mori M, Maekawa M, Suzuki H, Mano N

Tohoku J Exp Med. 2014;233(2):103-12.  2014

Accepted

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Total synthesis of (±)-lepadiformine a via radical translocation-cyclization reaction

Manabu Fujitani, Masami Tsuchiya, Kentaro Okano, Kiyosei Takasu, Masataka Ihara, Hidetoshi Tokuyama

Synlett  ( 5 ) 822 - 826 2010

Accepted,  ISSN  0936-5214

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A total synthesis of (±)-lepadiformine A was accomplished through construction of the 1-azaspiro[4.5]decane skeleton by a sequential radical translocation-cyclization reaction.

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