Urushihara, Hisashi

写真a

Affiliation

Faculty of Pharmacy, Department of Pharmacy 医薬品開発規制科学講座 (Shiba-Kyoritsu)

Position

Professor

Career 【 Display / hide

  • 1995.04
    -
    2008.03

    Eli Lilly Japan, K.K.

  • 2008.04
    -
    2012.09

    Kyoto University, School of Medicine and Public Health, Pharmacoepidemiology, Assistant Professor

  • 2012.10
    -
    2013.08

    Kyoto University, School of Medicine, Ethics Committee, Lecturer

  • 2013.09
    -
    2016.03

    Keio University, Faculty of Pharmacy, Associate Professor

  • 2016.04
    -
    Present

    Keio University, Faculty of Pharmacy, Division of Drug Development and Regulatory Science, Professor

Academic Background 【 Display / hide

  • 1992.03

    Hokkaido University, Faculty of Pharmaceutical Science

    Graduate School, Completed, Master's course

  • 2005.04
    -
    2008.03

    Kyoto University, School of Medicine and Public Health, 社会健康医学系専攻

    Graduate School, Completed, Doctoral course

Academic Degrees 【 Display / hide

  • 薬学修士, Hokkaido University, Coursework, 1992.03

  • 医学博士(社会健康医学), Kyoto University, Coursework, 2008.03

 

Research Areas 【 Display / hide

  • Life Science / Medical management and medical sociology (Epidemiology and pharmacoepidemiology)

  • Life Science / Medical technology assessment (Regulatory Sciences)

Research Keywords 【 Display / hide

  • Regulartory science

  • Pharmacovigilance

 

Books 【 Display / hide

  • ストロムの薬剤疫学(原書名 Textbook of Pharmacoepidemiology, Second Edition, Edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy. 2013)

    監修:川上浩司, 漆原尚巳, 田中司朗, 南山堂, 2019.10

  • スタンダード薬学シリーズII 薬学総論Ⅰ. 薬剤師としての基本事項.

    漆原 尚巳. 編日本薬学会, 東京化学同人. 東京., 2015

    Scope: 第Ⅱ部 薬剤師に求められる倫理観 第8章 研究倫理. SBO38, 39, 40.

  • 臨床現場で実践する薬学研究のススメ.

    漆原 尚巳,澤田康文, 南山堂. 東京., 2014.10

    Scope: Step 2-3.「統計ソフトの選び方と解析時のポイント」. pp122-135

  • 医薬品のレギュラトリーサイエンス

    豊島聰編, 黒川達夫編, 望月眞弓, 漆原尚巳, 他9名, 南山堂. 東京., 2014.02

    Scope: 第4章 患者・健常人で有効性や安全性を確かめるための手立て Ⅲ 臨床研究における統計学の基礎。pp77-87

  • 最悪に備えよ

    漆原尚巳. 編 杉森裕樹, 大神英一, 山本美智子, 折井孝男, 中山健夫, 株式会社じほう, 日本, 2013.06

    Scope: 第4章 危機管理のための一般モデルおよび理論 471

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Papers 【 Display / hide

  • Comparison of the incidence of bleeding between baloxavir marboxil and other anti-influenza drugs among outpatients with influenza virus infection: A retrospective cohort study using an employment-based health insurance claims database in Japan

    Hara, A., Hara, K., Komeda, T., Ogura, E., Miyazawa, S., Kobayashi, C., Fujiwara, M., Yoshida, M. and Urushihara, H.

    Pharmacoepidemiol Drug Saf (Pharmacoepidemiology and Drug Safety)   2021.12

    Research paper (scientific journal), Joint Work, Last author, Accepted,  ISSN  1099-1557

     View Summary

    PURPOSE: Alerts for bleeding events are included in the Japanese package inserts of some anti-influenza drugs, including baloxavir marboxil and oseltamivir. However, there are few reports on the incidence of bleeding events during treatment with anti-influenza drugs. This large-scale quantitative assessment compared the incidence of bleeding events in influenza patients treated with baloxavir and other anti-influenza drugs and in untreated patients. METHODS: This retrospective cohort study used a large-scale Japanese employment-based health insurance claims database provided by JMDC Inc. and included outpatients diagnosed with influenza between October 1, 2018 and April 11, 2019. Bleeding events were identified by International Classification of Diseases 10th revision codes. Incidences were compared between patients treated with baloxavir or neuraminidase inhibitors and untreated patients. Odds ratios were calculated after exact matching to adjust for potential confounders. RESULTS: Among 529 201 influenza episodes, 30 964 were untreated and 498 237 were treated with anti-influenza drugs: baloxavir, 207 630; oseltamivir, 143 722; zanamivir, 28 208; peramivir, 5304; laninamivir, 113 373. Crude incidence proportions for total bleeding up to 20 days after influenza diagnosis were similar among treated groups, with a slightly higher value for peramivir (0.21% vs. 0.19% for baloxavir, oseltamivir, zanamivir, and laninamivir), and 0.30% in untreated patients. After exact matching, the incidence of bleeding for baloxavir was similar to that for other anti-influenza treatments (odds ratios for baloxavir were 0.90-0.99 compared to other therapies). CONCLUSIONS: Based on real-world observation using a large-scale claims database, a similar incidence of bleeding events was observed in recipients of the different anti-influenza drugs.

  • Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region

    Tanemura N., Sasaki T., Sato J., Urushihara H.

    Trials (Trials)  22 ( 1 )  2021.12

    Research paper (scientific journal), Joint Work, Accepted

     View Summary

    Background: Incomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan. Thus, using the European Clinical Trials Database (EudraCT), this study aimed to identify the factors related to the study design and administration that lead to incompletion of clinical trials that included pediatric patients. Methods: We focused on clinical trials that included patients under the age of 18 registered in the database, named as the European Clinical Trials Database between January 1, 2014, and December 31, 2018. Two groups of trials were identified: “all cases completed” and “not all cases completed,” reflecting whether they were completed in all participating countries/regions or not. To identify the factors of the occurrence of “not all cases completed,” a logistic regression analysis was performed to calculate the odds ratios and 95% confidence intervals. In total, 142 clinical trials (95 “all cases completed” and 47 “not all cases completed”) were analyzed. Results: The logistic regression analysis showed the number of countries in which a clinical trial was conducted to be the only significant factor (odds ratio: 1.3; 95% confidence interval: 1.1-1.5); this was identified as the primary factor for the occurrence of “not all cases completed” in the clinical trials that included pediatric patients. Conclusion: Our findings suggest that the feasibility of clinical trials that include pediatric patients, such as whether the countries in which the trial is to be conducted are suitable, must be considered prior to the trial.

  • Lifestyle behaviors associated with the initiation of renal replacement therapy in Japanese patients with chronic kidney disease: a retrospective cohort study using a claims database linked with specific health checkup results

    Hara, A., Hirata, T., Okamura, T., Kimura, S. and Urushihara, H.

    Environ Health Prev Med (Environmental Health and Preventive Medicine)  26 ( 1 ) 102 2021.12

    Research paper (scientific journal), Joint Work, Last author, Corresponding author, Accepted,  ISSN  1342078X

     View Summary

    BACKGROUND: Chronic kidney disease (CKD) is an independent risk factor for progression to an end-stage renal disease requiring dialysis or kidney transplantation. We investigated the association of lifestyle behaviors with the initiation of renal replacement therapy (RRT) among CKD patients using an employment-based health insurance claims database linked with specific health checkup (SHC) data. METHODS: This retrospective cohort study included 149,620 CKD patients aged 40-74 years who underwent a SHC between April 2008 and March 2016. CKD patients were identified using ICD-10 diagnostic codes and SHC results. We investigated lifestyle behaviors recorded at SHC. Initiation of RRT was defined by medical procedure claims. Lifestyle behaviors related to the initiation of RRT were identified using a Cox proportional hazards regression model with recency-weighted cumulative exposure as a time-dependent covariate. RESULTS: During 384,042 patient-years of follow-up by the end of March 2016, 295 dialysis and no kidney transplantation cases were identified. Current smoking (hazard ratio: 1.87, 95% confidence interval, 1.04─3.36), skipping breakfast (4.80, 1.98─11.62), and taking sufficient rest along with sleep (2.09, 1.14─3.85) were associated with the initiation of RRT. CONCLUSIONS: Among CKD patients, the lifestyle behaviors of smoking, skipping breakfast, and sufficient rest along with sleep were independently associated with the initiation of RRT. Our study strengthens the importance of monitoring lifestyle behaviors to delay the progression of mild CKD to RRT in the Japanese working generation. A substantial portion of subjects had missing data for eGFR and drinking frequency, warranting verification of these results in prospective studies.

  • Behavioral changes and hygiene practices of older adults in Japan during the first wave of COVID-19 emergency

    Arai Y., Oguma Y., Abe Y., Takayama M., Hara A., Urushihara H., Takebayashi T.

    BMC Geriatrics (BMC Geriatrics)  21 ( 1 )  2021.12

    Research paper (scientific journal), Joint Work, Accepted

     View Summary

    Background: On April 7, 2020, Japan declared a state of emergency due to the first wave of coronavirus disease 2019 (COVID-19) with the associated social distancing likely to have had a great impact on older adults’ lifestyle and health. This study aimed to explore the behavioral changes and personal hygiene practices in relation with background psychosocial and health characteristics of older adults during the COVID-19 emergency. Methods: A cross-sectional telephonic survey was conducted with the participants of the Kawasaki Aging and Wellbeing Project (KAWP), an on-going longitudinal cohort study of older adults aged 85 or older. The interviews were conducted using a structured questionnaire consisting of 11 closed questions regarding behavioral changes and personal hygiene practices during the state of emergency. Sociodemographic and health data were obtained from the KAWP baseline survey conducted 2.2 years before the telephonic survey. Results: Overall, 487 participants from the KAWP responded to the telephonic survey (response rate: 89.2%). 94.5% of the respondents reported no changes in basic lifestyle habits, such as eating, sleeping, smoking, and drinking, whereas 28.1% reported a decrease in physical activity, and 54.6% reported going out less frequently. One-third of the respondents reported a decrease in the number of people to converse with, as well as the amount of time to converse. For personal hygiene practices, 93.8% reported wearing a mask when they went out, and 50.3% reported an increased frequency of handwashing. Multiple logistic regression analysis revealed that engagement in physical activity at baseline (odds ratio [OR] = 1.95, 95% confidence interval [CI] = 1.23–3.08), smartphone ownership (OR = 2.15, 95% CI = 1.33–3.47), and visual impairment (OR = 1.79; 95% CI = 1.10–2.91) were independently associated with decreased physical activity during the COVID-19 emergency. Female respondents and smartphone ownership were significantly associated with more frequent handwashing. Conclusions: The study revealed that older adults in an urban setting responded to the COVID-19 emergency with behavioral changes. The findings of this study have implications for the design of preventive strategies to maintain the health and wellbeing of at-risk older adults.

  • Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with anticonvulsants in a Japanese population: Matched case–control and cohort studies

    Fukasawa T., Takahashi H., Takahashi K., Tanemura N., Amagai M., Urushihara H.

    Allergology International (Allergology International)  70 ( 3 ) 335 - 342 2021.07

    Research paper (scientific journal), Joint Work, Last author, Corresponding author, Accepted,  ISSN  13238930

     View Summary

    Background: Evidence for the risk and incidence of anticonvulsant-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in Japan is scarce. Methods: We conducted a matched case–control study using a large-scale Japanese claims database. SJS/TEN cases were identified using a claims-based algorithm developed in a previous study (sensitivity 76.9%, specificity 99.0%). Conditional logistic regression with Firth's bias correction to address an issue of rare events was used to estimate odds ratios (ORs) for SJS/TEN for each anticonvulsant use (90 days before the index date) versus non-use. 90-day cumulative incidence of SJS/TEN per 100,000 new users was calculated for 33 anticonvulsants. Causality between anticonvulsant use and SJS/TEN in each exposed case was assessed using the algorithm of drug causality for epidermal necrolysis (ALDEN) score. Results: From 5,114,492 subjects, we selected 71 SJS/TEN cases and 284 controls. We observed significantly increased ORs for SJS/TEN among new users of carbamazepine (OR 68.00) and lamotrigine (OR 36.00) with ALDEN scores of “probable” or higher. Cumulative incidence of SJS/TEN was 93.83 for carbamazepine and 84.33 for lamotrigine. One case newly exposed to phenytoin which developed SJS/TEN was rated “unlikely” in ALDEN causality, resulting in cumulative incidence of 66.27. Cumulative incidence of SJS/TEN was 25.23 for levetiracetam, 7.52 for clonazepam, and 1.23 for diazepam, but their ALDEN scores were “very unlikely”. Conclusions: This study is the first to document the differential risk of SJS/TEN for anticonvulsants in a real-world setting in Japan. Exposure to carbamazepine and lamotrigine was associated with an increased risk of SJS/TEN.

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Papers, etc., Registered in KOARA 【 Display / hide

Reviews, Commentaries, etc. 【 Display / hide

  • Correction: Influenza vaccination effectiveness for people aged under 65 years in Japan, 2013/ 2014 season: Application of a doubly robust method to a large-scale, real-world dataset (BMC Infectious Diseases DOI: 10.1186/s12879-019-4186-x)

    Shibata N., Kimura S., Hoshino T., Urushihara H.

    BMC Infectious Diseases (BMC Infectious Diseases)  19 ( 1 )  2019.08

     View Summary

    © The Author(s). 2019. After publication of the original article [1], in Table 1, in the second and third column, Vacnee and Non-vacnee should be replaced with Vaccinee and Non-vaccinee. The original article has been corrected. The publisher apologies for the inconvenience.

  • The Long Road to Perfect Harmony

    the Medicine Maker (UK: Texere Publishing Limited)   2017.10

  • 【薬剤疫学〜医療ビッグデータの利活用〜】 医薬品使用実態研究Drug Utilization Study 民間のデータベースを用いた医薬品の使用動向に関する研究

    Urushihara Hisashi

    医薬ジャーナル (医薬ジャーナル社)  52 ( 8 ) 1889 - 1894 2016.08

    Article, review, commentary, editorial, etc. (scientific journal)

  • 薬局発の情報学 変貌する医療のフロントエンド

    Urushihara Hisashi

    ファルマシア 51 ( 2 ) 135 - 139 2015.02

    Article, review, commentary, editorial, etc. (scientific journal), Single Work

  • Lifecycle Risk Assessment ~ CIOMS Working Group VI報告書及び米国研究製薬工業団体SPERTによる提案

    Urushihara Hisashi

    薬剤疫学 19 ( (2) )  2015.02

    Article, review, commentary, editorial, etc. (scientific journal), Single Work

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Presentations 【 Display / hide

  • 医療情報データベースを用いるためのOutcome Definition Repository(ODR)の構築 日本薬剤疫学ODR-Task Force報告

    井上 慧哉,岩上 将夫, 小野 利展, 北島 行雄, 木村 友美, 佐藤 泉美, 杉田 玲夢, 杉山 大典, 原 梓, 宮崎 真, 米倉 寛, 漆原 尚巳

    第26回日本薬剤疫学会学術総会, 

    2021.11

    Poster presentation

  • 医療情報データベースを用いた日本の抗菌薬による感染症治療の実態調査

    雨宮 優理, 原 梓, 田中 啓太, 漆原 尚巳

    第26回日本薬剤疫学会学術総会, 

    2021.11

    Oral presentation (general)

  • 有害事象予測に向けたElectronic Hospital Recordsに対する分散表現の適用

    石川 智貴, 矢向 高弘, 漆原 尚巳

    第26回日本薬剤疫学会学術総会, 

    2021.11

    Oral presentation (general)

  • 抗菌薬・抗真菌薬の使用とスティーヴンス・ジョンソン症候群及び中毒性表皮壊死症のリスク

    深澤 俊貴, 漆原 尚巳, 高橋 勇人, 川上 浩司

    第26回日本薬剤疫学会学術総会, 

    2021.11

    Oral presentation (general)

  • 三本の矢(マッチング、自己対照、トレンド分析)によるバロキサビルマルボキシルの出血リスク評価

    米田 卓司, 原 梓, 原 華苗, 小倉 江里子, 藤原 正和, 宮澤 昇吾, 吉田 真奈美, 漆原 尚巳

    第26回日本薬剤疫学会学術総会, 

    2021.11

    Oral presentation (general)

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Research Projects of Competitive Funds, etc. 【 Display / hide

  • Outcome definition repository for epidemiological research utilizing electronic medical record databases

    2021.04
    -
    2024.03

    MEXT,JSPS, Grant-in-Aid for Scientific Research, Grant-in-Aid for Scientific Research (C), Principal investigator

  • ウェアラブルデバイスを使用したがん性疼痛管理における医療用麻薬の客観的有用性評価

    2016
    -
    2018

    文部科学省, 平成28年度 基盤研究(C), Principal investigator

  • スイッチOTC薬導入による医療用医薬品処方への影響と社会経済学的効用の評価

    2014
    -
    Present

    薬学研究奨励財団, 研究助成金グループB, No Setting, Principal investigator

  • 創薬ルネサンス:既承認薬の滞在能力を引き出す体内資源活用の研究基盤形成

    2014
    -
    2017

    文部科学省, 私立大学戦略的研究基盤形成支援事業, Coinvestigator(s)

  • 患者及び医療関係者との医薬品等安全対策情報のリスクコミュニケーションに関する研究

    2013
    -
    2014

    厚生労働省, 厚生労働省科学研究費補助金, Coinvestigator(s)

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Awards 【 Display / hide

  • 第二回藤田賞 薬剤疫学分野受賞

    2014.03

    Type of Award: Award from Japanese society, conference, symposium, etc.

  • 第2回 藤田利治賞

    Urushihara H., 2014.03, 統計数理研究所, 第2回 藤田利治賞 薬剤疫学分野.

 

Courses Taught 【 Display / hide

  • STUDY OF MAJOR FIELD: (DRUG DEVELOPMENT AND REGULATORY SCIENCE)

    2022

  • SEMINAR: (DRUG DEVELOPMENT AND REGULATORY SCIENCE)

    2022

  • RESEARCH FOR BACHELOR'S THESIS 1

    2022

  • REGULATORY SCIENCE ADVANCED COURSE

    2022

  • PRINCIPLES OF HEALTH MANAGEMENT

    2022

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Courses Previously Taught 【 Display / hide

  • C17(1)医薬品開発と生産のながれ

    Keio University

    2014.04
    -
    2015.03

    Spring Semester, Lecture

  • C17(4)(5)治験・バイオスタティスティクス

    Keio University

    2014.04
    -
    2015.03

    Autumn Semester, Lecture

  • 薬学英語

    Keio University

    2014.04
    -
    2015.03

    Spring Semester, Lecture, Within own faculty

  • 臨床薬物評価学

    Keio University

    2014.04
    -
    2015.03

    Spring Semester, Lecture

Educational Activities and Special Notes 【 Display / hide

  • 慶應義塾大学薬学部医薬品開発規制科学講座学生指導

    2015
    -
    Present

    , Device of Educational Contents

 

Social Activities 【 Display / hide

  • 日本製薬医学会 理事

    2015.07
    -
    2018.03

     View Summary

    理事

  • 日本薬剤疫学会

    2013.10
    -
    Present

     View Summary

    理事

  • 恩賜財団済生会病院 

    2013.10
    -
    2018.03

     View Summary

    中央治験審査委員会 委員

  • 日本薬剤疫学会

    2013.04
    -
    Present

     View Summary

    適正なリスク管理計画実施のためのガイドライン作成タスクフォース 委員

  • 日本臨床腫瘍薬学会 

    2012.05
    -
    Present

     View Summary

    臨床研究委員会 委員

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Memberships in Academic Societies 【 Display / hide

  • 日本臨床疫学会, 

    2017.03
    -
    Present
  • 日本薬剤疫学会

     
  • 日本臨床腫瘍薬学会

     
  • 日本臨床試験研究会

     
  • 日本医薬品情報学会

     

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Committee Experiences 【 Display / hide

  • 2019.11
    -
    Present

    理事長, 日本薬剤疫学会 

  • 2013.09
    -
    Present

    理事、COI委員会委員長, 日本薬剤疫学会 

  • 2013.04
    -
    2014.03

    適正なリスク管理計画実施のためのガイドライン作成タスクフォース 委員, 日本薬剤疫学会 

  • 2010.03
    -
    2013.08

    医の倫理委員会 委員, 京都大学大学院医学研究科・医学部及び医学部附属病院 未承認医薬品等臨床研究・医師主導治験小委員会 

  • 2008.04
    -
    2016.03

    疫学コンサルタント, 日本イーライリリー株式会社安全性情報部