Papers - Urushihara, Hisashi

The need for consumer science and regulatory science research on functional foods with health claims - What should we do to harmonize science and technology with society?

Tanemura N, Hamadate N, Urushihara H.

Trends in Food Science & Technology (ELSEVIER SCIENCE LONDON)  67 ( 67 ) 280 - 283 2017

Joint Work,  ISSN  0924-2244

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Background: According to the Codex Alimentarius of the foods with health claims (FHCs), two major factors play a significant role in the ability for consumers to select functional foods and utilize them appropriately for health maintenance (Codex Alimentarius, 1997). These are: 1) food labeling based on scientific evidence that consumers are able to understand; and 2) standardized criteria for obtaining scientific evidence.
Scope and approach: We discuss the regulatory system for foods with health claims in the world and the need for consumer science and regulatory science research through reviewing the history and recent topics about the regulation on FHCs in Japan.
Key findings and conclusions: There are some differences in regulations on FHCs among countries participating in the Codex, which have been said sometimes to cause some troubles. These are: 1) despite of the lack of renewal system, Japan experienced the first revocation event regarding the approved Foods for Specified Health Uses category of FHCs in 2016; and 2) global export barriers. Therefore, the introduction of mutual recognition rules among countries has been desired in Japan for further international harmonization. However, its feasibility seems to be low because of the complexity caused by such differences on regulations among countries. When it happens, we expect that the global regulatory climates on FHCs may be better regulated by involving neutral academic researchers and the trained experts in the field of consumer and regulatory science of functional foods. As Japan is the first country to establish the FHCs regulatory system in the world, it should lead to discuss the introduction of mutual recognition rules with other countries immediately. (C) 2017 Elsevier Ltd. All rights reserved.

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製造販売後調査における被験者同意と倫理審査

漆原尚巳, 村上結香, 松井健志, 田代志門

YAKUGAKU ZASSHI (全国病院調査)   2017

Joint Work

新たな研究倫理指針「人を対象とする医学系研究に関する倫理指針」と研究倫理の枠組み

Urushihara Hisashi

月刊薬事 57 ( 13 ) 2173 - 2178 2015.12

Research paper (scientific journal), Single Work

Price difference as a predictor of the selection between brand name and generic statins in Japan

Takizawa, Osamu, Urushihara, Hisashi, Tanaka, Shiro, Kawakami, Koji

HEALTH POLICY (ELSEVIER IRELAND LTD)  119 ( 5 ) 612 - 619 2015.05

Research paper (scientific journal), Joint Work, Accepted,  ISSN  0168-8510

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Objectives: This study aimed to explore the predictors of the selection between brand name drug (BR) and generic drug (GE) and to clarify the quantitative relationship about selection.
Methods: We identified "incident users" who dispensed statins between April 2008 and June 2011 in commercially databases consisted of dispensing claims databases (DCD) of out-of-hospital pharmacies and hospital claims databases (HCD) of in-house pharmacies in Japan. Predictors of the selection between BR and GE, including price difference (PD), the price of BR, their interaction and percent change of the price of GE relative to BR were explored by logistic regression using DCD and HCD separately.
Results: We extracted records of 670 patients who have opportunity for selection both BR and GE. Logistic regression analysis demonstrated that PD, the price of BR, interaction between them, and prescriber affiliation were factors significantly associated with the selection in the DCD; logit (p) = 9.735 - 0.251 x PD - 0.071 x the price of BR+0.002 x PD x the price of BR -1.816 x affiliation + 0.220 x gender 0.008 x age + 0.038 x monthly medical fee. PD was inversely proportional to BR choice in DCD and lead to the opposite result in HCD. Numerical simulation of selection revealed that the quantitative relationships heavily depend on situations.
Conclusions: PD and the price of BR are predictors of the selection between BR and GE interactively in out-of-hospital pharmacies, but not in in-house pharmacies of medical facilities. Results may support policies which increase the power of out-of-hospital pharmacies for selection. (C) 2015 Elsevier Ireland Ltd. All rights reserved.

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Prescription patterns and trends in anti-rheumatic drug use based on a large-scale claims database in Japan

Katada, Hirotaka, Yukawa, Naoichiro, Urushihara, Hisashi, Tanaka, Shiro, Mimori, Tsuneyo, Kawakami, Koji

CLINICAL RHEUMATOLOGY (SPRINGER LONDON LTD)  34 ( 5 ) 949 - 956 2015.05

Research paper (scientific journal), Joint Work, Accepted,  ISSN  0770-3198

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This drug utilization study aimed to investigate prescription patterns and trends for anti-rheumatic drug use in Japanese patients with rheumatoid arthritis (RA), clarifying if patients with RA in Japan are being treated according to EULAR recommendations and ACR guidelines. We used a large-scale claims database consisting of the medical claims of employee health insurance recipients, which included approximately one million insured people. The claims data for incident 5,126 patients with diagnosis codes of RA between January 1, 2005 and October 31, 2011 were analyzed. The number of patients who received disease modifying antirheumatic drugs (DMARDs) including biologics as initial therapy was 629 (12.3 %), while the others received non-DMARD therapy only. During the study period, use of methotrexate (MTX) and biologics as first-line drugs increased from 1.9 to 8.0 % and from 0 to 1.6 %, respectively (p < 0.001 for both), while that of non-steroidal anti-inflammatory drugs (NSAIDs) decreased (p = 0.004). Time from first RA diagnosis to the start of treatment with DMARDs decreased significantly from 2005 to 2010. These findings suggest that many early RA patients in Japan do not yet receive aggressive treatment, albeit that this prescribing practice has gradually changed to better comply with clinical recommendations. The current, obsolete Japanese RA guidelines require urgent updating to reflect the most recent knowledge and care with effective treatment modalities.

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Domperidone With ORT in the Treatment of Pediatric Acute Gastroenteritis in Japan: A Multicenter, Randomized Controlled Trial

Kita, Fumiyo, Hinotsu, Shiro, Yorifuji, Tohru, Urushihara, Hisashi, Shimakawa, Tetsuro, Kishida, Kenji, Wakazono, Yoshihiro, Yamauchi, Eiko, Sasaki, Hiroshi, Nakahata, Tatsutoshi, Kawakami, Koji

ASIA-PACIFIC JOURNAL OF PUBLIC HEALTH (SAGE PUBLICATIONS INC)  27 ( 2 ) NP174 - NP183 2015.03

Research paper (scientific journal), Joint Work, Accepted,  ISSN  1010-5395

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Domperidone is an antiemetic that is often prescribed for children with acute gastroenteritis in Japan. In this study, the authors assessed the efficacy of domperidone prescription in combination with oral rehydration treatment (ORT) in the treatment of vomiting during acute gastroenteritis in children during the early period. They performed a prospective multicenter randomized trial in Japan. Patients received either ORT or ORT and domperidone prescription. The primary outcome was the proportion of patients who had vomiting during the first 2 hours after randomization. A total of 56 children were eligible; 24 received ORT alone, and 32 received ORT and prescribed domperidone suppository. Results showed that 27.3% of children in the ORT group vomited as compared with 20.7% of children in the ORT and domperidone group (P = .41). In this study, it appears that domperidone in combination with ORT in the treatment of acute gastroenteritis does not reduce vomiting in the early period.

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Cost-effectiveness analysis of EGFR mutation testing and gefitinib as first-line therapy for non-small cell lung cancer

Narita, Yusuke, Matsushima, Yukiko, Shiroiwa, Takeru, Chiba, Koji, Nakanishi, Yoichi, Kurokawa, Tatsuo and Urushihara, Hisashi

Lung Cancer 90 ( 1 ) 71 - 77 2015

Research paper (scientific journal),  ISSN  0169-5002

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AbstractObjectives The combination use of gefitinib and epidermal growth factor receptor (EGFR) testing is a standard first-line therapy for patients with non-small cell lung cancer (NSCLC). Here, we examined the cost-effectiveness of this approach in Japan. Materials and methods Our analysis compared the ‘EGFR testing strategy’, in which EGFR mutation testing was performed before treatment and patients with EGFR mutations received gefitinib while those without mutations received standard chemotherapy, to the ‘no-testing strategy,’ in which genetic testing was not conducted and all patients were treated with standard chemotherapy. A three-state Markov model was constructed to predict expected costs and outcomes for each strategy. We included only direct medical costs from the healthcare payer's perspective. Outcomes in the model were based on those reported in the Iressa Pan-Asia Study (IPASS). The incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted life-years (QALYs) gained. Sensitivity and scenario analyses were conducted. Results The incremental cost and effectiveness per patient of the ‘EGFR testing strategy’ compared to the ‘no-testing strategy’ was estimated to be approximately JP¥122,000 (US$1180; US$1 = JP¥104 as of February 2014) and 0.036 QALYs. The ICER was then calculated to be around JP¥3.38 million (US$32,500) per QALY gained. These results suggest that the ‘EGFR testing strategy’ is cost-effective compared with the ‘no-testing strategy’ when JP¥5.0 million to 6.0 million per QALY gained is considered an acceptable threshold. These results were supported by the sensitivity and scenario analyses. Conclusion The combination use of gefitinib and EGFR testing can be considered a cost-effective first-line therapy compared to chemotherapy such as carboplatin–paclitaxel for the treatment for NSCLC in Japan.

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Utilization trends and management and prescription of oral anticancer medicines using nationwide pharmacy databases and a questionnaire survey of community pharmacies in Japan

Takizawa O, Urushihara H, Tanaka S, Doi Y, Arai M, Matsunaga T, Ogata N, Kawakami K

International Journalof Pharmacy and Pharmaceutical Research 4 ( 3 ) 150 - 163 2015

Research paper (scientific journal), Joint Work, Accepted

Medications associated with falls in older people: systematic review of publications from a recent 5-year period

Hyerim Park, Hiroki Satoh, Akiko Miki, Hisashi Urushihara, Yasufumi Sawada

European Journal of Clinical Pharmacology (SPRINGER HEIDELBERG)  71 ( 12 ) 1429 - 1440 2015

Research paper (scientific journal), Joint Work, Accepted,  ISSN  0031-6970

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Falls are an important public health problem in older people. Medication use is considered a risk factor for falls. This study systematically reviewed recent studies to determine the medications that might be associated with the risk of falling in older people.
We conducted a systematic review of prospective and retrospective studies identified through the MEDLINE and CINAHL databases that quantitatively assessed the contribution of medications to falls risk in participants a parts per thousand yen60 years old published in English between May 2008 and April 2013.
The search identified 1,895 articles; 36 articles met the inclusion criteria. Of the 19 studies that investigated the effect of polypharmacy on the risk of falling, six studies reported that the risk of falling increased with polypharmacy. Data on the use of antihypertensive medications including calcium channel blockers, beta-blockers, and angiotensin system blocking medications were collected in 14 studies, with mixed results. Twenty-nine studies reported an association between the risk of falls and psychotropic medications including sedatives and hypnotics, antidepressants, and benzodiazepines.
The use of sedatives and hypnotics and antidepressants including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors appears to be related with an increased risk of falls. It is not clear if the use of antihypertensive medications is associated with the risk of falls in older people.

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Patterns and trends in diagnostic tests used for detection of colorectal cancer after screening with the immunochemical fecal occult blood test in Japan

Yamamichi J, Seto K, Hinotsu S, Nagata K, Kobayashi Y, Urushihara H, Kawakami K

Open Journal of Clinical Diagnostics 5   107 - 116 2015

Research paper (scientific journal), Joint Work, Accepted

医療上の必要性の高い未承認薬・適応外薬検討会議」において検討された適応外薬の申請形態

伊藤知美, 漆原尚巳, 松嶋由紀子, 中島慶太郎, 黒川達夫

臨床薬理 46(5)   233 - 241 2015

Research paper (scientific journal), Joint Work, Accepted

Responsiveness of the Japanese Osteoporosis Quality of Life questionnaire in women with postmenopausal osteoporosis

Urushihara Hisashi,Yoh K, Hamaya E, Taketsuna M, Tanaka K

Health Qual Life Outcomes 12   178 2014.12

Research paper (scientific journal), Joint Work, Accepted

Application of a self-controlled case series study to a database study in children

Ueyama H, Hinotsu S, Tanaka S, Urushihara H, Nakamura M

Drug Saf 37   259-268 2014.03

Research paper (scientific journal), Joint Work, Accepted

Academic clinical trials and drug regulations in japan: impacts of introducing the investigational new drug system.

Urushihara H, Kawakami K.

Therapeutic Innovation & Regulatory Science 48(4)   463-472 2014.02

Research paper (scientific journal), Joint Work, Accepted

Utilization of antipsychotic drugs in elderly patients with alzheimer's disease seen in ambulatory practice in japan.

Urushihara H, Kobayashi S, Honjo Y, Kosugi S, Kawakami K.

Science Postprint 1(1)   e00014 2014.01

Research paper (scientific journal), Joint Work, Accepted

Pharmaceutical company perspectives on current safety risk communications in Japan.

Urushihara H, Kobashi G, Masuda H, Taneichi S, Yamamoto M, Nakayama T, Kawakami K, Matsuda T, Ohta K, Sugimori H.

SpringerPlus 3(1)   51 2014.01

Research paper (scientific journal), Joint Work, Accepted

Prescribing pattern of anti-Parkinson drugs in Japan: a trend analysis from 2005 to 2010

Nakaoka S, Ishizaki T, Urushihara H, Satoh T, Ikeda S, et al.

PLoS One 9   e99021 2014

Research paper (scientific journal), Joint Work, Accepted

Transaction cost analysis of the new drug application process: a case study of a multinational pharmaceutical company in japan.

Hamada S, Shibata A, Urushihara H, Sengoku S, Suematsu C, Kawakami K.

Therapeutic Innovation & Regulatory Science 48(3)   371-7 2013.12

Research paper (scientific journal), Joint Work, Accepted

Biased safety reporting in blinded randomized clinical trials: meta-analysis of angiotensin receptor blocker trials.

Takabayashi N, Urushihara H, Kawakami K.

PLoS one 8(9)   e75027 2013.09

Research paper (scientific journal), Joint Work, Accepted

Economic evaluation of pravastatin for primary prevention of coronary artery disease based on risk prediction from JALS-ECC in japan.

Onishi Y, Hinotsu S, Nakao YM, Urushihara H, Kawakami K.

Value in Health Regional Issues 2(1)   5-12 2013.02

Research paper (scientific journal), Joint Work, Accepted