Details of a Researcher - Tsuchiya, Masami

Papers - Tsuchiya, Masami

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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

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

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

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

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

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

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 Sr0.6Ba0.4Nb2O6 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

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

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

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

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

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

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

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

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

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

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

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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