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

E-mail Address

E-mail address

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

    JAPAN, 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

    JAPAN, 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

  • Epidemiology and preventive medicine (Epidemiology and pharmacoepidemiology)

  • Medical engineering assessment (Regulatory Sciences)

  • Medical engineering assessment (Health Technology Assessment)

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

  • The first survey of gap between the actual labelling and efficacy information of functional substances in food under the regulatory processes in Japan

    Tanemura N., Machii Y., Urushihara H.

    Journal of Functional Foods (Journal of Functional Foods)  72 2020.09

    ISSN  17564646

     View Summary

    © 2020 The Author(s) To make well-informed choices, consumers need access to reliable and clear messages regarding the benefits of functional substances in food. This study identified foods with function claims (FFCs) in Japan that had a gap between actual labeling and efficacy information of functional substances not visible on their food package. Between April 1, 2015, to July 20, 2018, 1,310 FFCs were submitted to the regulatory agency and analyzed. The proportion of FFCs with a gap was highest in the health claim category of blood pressure management (79.5%), followed by neutral fat reduction in blood (75%) and suppression of blood sugar spikes (73.4%). These gaps are attributable to differences in food development strategy. Thus, to ensure the quality of benefit communication on FFC to consumers, scientific evidence regarding health claims of functional substances should be managed in an integrated manner.

  • Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan

    Tanemura, Nanae, Sasaki, Tsuyoshi, Sato, Junko and Urushihara, Hisashi

    The Patient - Patient-Centered Outcomes Research  2020

    ISSN  1178-1661

     View Summary

    The updated international draft guidelines, the “General Considerations for Clinical Studies, ICH E8 (R1)”, state that patient engagement ensures that all perspectives are captured in the research process; however, this is not well understood, specifically in Japan.

  • 自発報告に基づくシグナル検出ができること,できないこと ―その理論と実践―

    漆原尚巳

    医薬品情報学 21 ( 4 ) 135 - 141 2020

  • 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

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

    BMC Infectious Diseases (BMC Infectious Diseases)  19 ( 1 )  2019.07

     View Summary

    © 2019 The Author(s). Background: Influenza vaccination is recognized as a primary public health intervention which prevents the illness of patients and relieves the societal burdens of influenza for medical community as well as the economy. To date, no effectiveness study of influenza vaccination has been conducted including a large population with a wide age span, in Japan. Here, we evaluated the clinical effectiveness of influenza vaccination in a large Japanese population. Methods: We conducted a cohort study using a large-scale claims database for employee health care insurance plans. Vaccination status was identified using plan records for influenza vaccination subsidies. We excluded people aged 65 years or more because of the unavailability of vaccination records. Effectiveness of vaccination in preventing influenza and its complication was evaluated with doubly robust methods using inversed probability treatment weighting to adjust health conscious behaviours and other confounders. Results: During the 2013/2014 influenza season, 369,425 subjects with age range from 1 to 64 years were eligible. Vaccination rate was 39.5% and an estimated odds ratio (OR) for influenza onset was 0.775 after doubly robust adjustment. Age-stratified ORs were significantly reduced in all age groups; lowest in subjects aged 1 to 4 years (0.600) and highest in those aged 13 to 19 (0.938). ORs for all the influenza complication outcomes were also statistically significant (0.403-0.709). Conclusions: We confirmed the clinical effectiveness of influenza vaccination in people aged 1 to 64 years. Influenza vaccination significantly prevented influenza onset and was more effective in reducing secondary risks of influenza complications.

  • Comparative effectiveness and safety of warfarin and dabigatran in patients with non-valvular atrial fibrillation in Japan: A claims database analysis

    Koretsune Y, Yamashita T, Yasaka M, Ono Y, Hirakawa T, Ishida K, Kuroki D, Sumida T, Urushihara H

    J Cardiol (Journal of Cardiology)  73 ( 3 ) 204 - 209 2019

    ISSN  09145087

     View Summary

    © 2018 The Authors Background: Antithrombotic therapy, including direct oral anticoagulants, is recommended in patients with non-valvular atrial fibrillation (NVAF) who are at intermediate-to-high risk of stroke. The aims of this study were to assess the patterns of oral anticoagulant (OAC) prescription in Japanese patients with NVAF and compare the effectiveness and safety of dabigatran and warfarin. Methods: This was a retrospective observational study of adults with NVAF who initiated dabigatran or warfarin between March 14, 2011 and June 30, 2016, using electronic claims data of approximately 12.94 million patients from 230 hospitals. Propensity score matching was used to derive equal patient cohorts. Outcomes included the combined incidence of stroke, systemic embolism, and intracranial bleeding (primary endpoint) and the incidence of major bleeding (secondary endpoint). Results: Overall, 400,884 patients were included. Among those prescribed an OAC, warfarin was the most common (34.3%). For the comparison of dabigatran and warfarin, 4606 patients were propensity-score matched in each cohort. Dabigatran recipients had lower incidences of stroke, systemic embolism, and intracranial bleeding [29.0 vs. 35.6 per 1000 patient-years; hazard ratio (HR), 0.72; 95% confidence interval (CI): 0.53–0.97; p = 0.031] and major bleeding (6.4 vs. 11.3 per 1000 patient-years; HR, 0.55; 95% CI: 0.30–0.99; p = 0.048). The most common type of bleeding in both groups was gastrointestinal and the incidence was lower in dabigatran recipients (1.6 vs. 6.4 per 1000 patient-years; HR, 0.24; 95% CI: 0.08–0.69; p = 0.009). Conclusions: In Japan, dabigatran was associated with a lower risk of stroke, systemic embolism, and intracranial bleeding and major bleeding compared with warfarin in patients with NVAF.

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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

    Introduction and explanation (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

    Introduction and explanation (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

    Introduction and explanation (scientific journal), Single Work

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Presentations 【 Display / hide

  • Drug Burden Of Polypharmacy And Anticholinergic/sedative Drugs And Physical/cognitive/mental Related Outcomes Of The Community-dwelling Elderly People: The Kawasaki Well-being Project"

    Ringo Asano, Asahi Tanaka, Yasumichi Arai, Takumi Hirata, Yukiko Abe, Yuko Oguma, Hisashi Urushihara

    The 35th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2019) (Philadelphia, PA) , 2019.08

  • Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with anticonvulsants in a Japanese population

    Toshiki Fukasawa, Hayato Takahashi, Nanae Tanemura, Masayuki Amagai, Hisashi Urushihara

    The 35th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2019) (Philadelphia, PA) , 2019.08

  • 生体情報常時モニタリングによる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

    飯村翔平, 種村菜奈枝, 和田敦, 松井礼子, 鈴木賢一, 中田和宏, 漆原尚巳

    日本臨床腫瘍薬学会学術大会2019 (札幌) , 2019.03

  • 地域在住高齢者におけるポリファーマシーと抗コリン作動薬及び鎮静作用薬が身体・認知・精神に与える影響の評価:The Kawasaki Wellbeing Project

    田中あさひ, 新井康通, 平田匠, 阿部由紀子, 小熊祐子, 漆原尚巳

    日本薬学会 第139年会 (幕張) , 2019.03

  • 平成28年度診療報酬改定前後における湿布薬の使用実態調査

    古畑汐梨, 漆原尚巳

    日本薬学会 第139年会 (幕張) , 2019.03

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

  • 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), 漆原尚巳, 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, 慶應義塾大学薬学部 三澤日出巳, Co-investigator

  • 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, 杉森裕樹, Co-investigator

  • 健康危機管理事態において用いる医学的対処の研究開発環境に関する研究

    2012.03
    -
    Present

    厚生労働省, Health and Labour Sciences Research Grants, 竹内勤, Co-investigator

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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: Awards of National Conference, Council and Symposium.  Country: 日本

  • 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

  • PHARMACEUTICAL LAW AND THE LEGAL SYSTEM

    2020

  • PHARMACEUTICAL LAW 2

    2020

  • PHARMACEUTICAL LAW 1

    2020

  • MEDICAL STATISTICS

    2020

  • INVITATION TO THE PHARMACEUTICAL SCIENCES

    2020

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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, Spring Semester, Major subject, Lecture

  • C17(4)(5)治験・バイオスタティスティクス

    Keio University, 2014, Autumn Semester, Major subject, Lecture

  • 薬学英語

    Keio University, 2014, Spring Semester, General education subject, Lecture, Within own faculty

  • 臨床薬物評価学

    Keio University, 2014, Spring Semester, Major subject, 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
  • 日本医薬品情報学会

     
  • Drug Information Association

     
  • International Society of Pharmacoepidemiology

     
  • 日本臨床疫学会

     

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Committee Experiences 【 Display / hide

  • 2015.07
    -
    Present

    理事, 日本製薬医学会

  • 2014.11
    -
    Present

    Medical Safety部会 部会長, 日本製薬医学会

  • 2013.10
    -
    Present

    中央治験審査委員会 委員, 恩賜財団済生会病院 

  • 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 

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