Papers - Tsuchiya, Masami

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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