2 0 0 0 OA 内用抗がん薬適正使用のための簡易懸濁法可否情報一覧表の作成
- 著者
- 天野 学 比知屋 寛之 安 智美 清原 義史 座間味 義人 瀬戸 衛 井上 徹雄 田中 一穂 倉田 なおみ 駒田 富佐夫
- 出版者
- 日本社会薬学会
- 雑誌
- 社会薬学 (ISSN:09110585)
- 巻号頁・発行日
- vol.32, no.2, pp.43-47, 2013-12-10 (Released:2015-06-26)
- 参考文献数
- 28
- 被引用文献数
- 1 1
In cancer chemotherapy, it is very important to take into account the patient’s background. In recent years, a simple suspension method has attracted increased attention as a method that prevents changes in the stability and safety of various drugs. However, of 135 oral anticancer drugs, only 28 have been examined using this method, as of April 2013. In this study, we carefully investigated whether 53 oral anticancer drugs could be adapted to the simple suspension method, except for the 28 drugs that had already been previously reported. The results showed that most of these oral anticancer drugs could be adapted to the simple suspension method. Of seven drugs that were not adapted, six were generic drugs. In addition, it was clear that the evaluation of bicalutamide tablets was significantly different from our expected results. In conclusion, we were able to qualitatively assess all 53 oral anticancer drugs. This is equivalent to half of 107 untested drugs. These results provide useful information to cancer patients using oral anticancer drugs prepared using the simple suspension method.
2 0 0 0 OA カルバマゼピンとラモトリギンが関連した副作用の現状調査:
- 著者
- 駒田 富佐夫 栗岡 恵一
- 出版者
- 一般社団法人日本医薬品情報学会
- 雑誌
- 医薬品情報学 (ISSN:13451464)
- 巻号頁・発行日
- vol.19, no.2, pp.72-81, 2017 (Released:2017-09-07)
- 参考文献数
- 51
Objective: We previously showed that interstitial lung disease, pneumonia, abnormal liver function, and anaphylactic reactions were frequent adverse events, and we analyzed outcomes, suspected causative drugs, and the onset of adverse events using information derived from the “Japanese Adverse Drug Event Report” (JADER) database. Here, we aimed to determine the status of actual adverse reactions to carbamazepine (CBZ) and lamotrigine (LTG) using national public databases.Methods: Data from the “Information on Decision on Payment/non-payment of Adverse Reaction Relief Benefits” (IARRB; April 2012-March 2016) and JADER (April 2012-March 2016) databases were downloaded from the website of the Pharmaceuticals and Medical Devices Agency. Information from the national database of the “Health Insurance Claims and Specific Health Checkups of Japan” (NDB) (April 2014-March 2015) was downloaded from the website of the Ministry of Health, Labour and Welfare.Results: The numbers of females and males in the IARRB were 169 and 229, respectively, for CBZ and 135 and 56, respectively, for LTG. Those in JADER were 1,152 and 1,352, respectively, for CBZ and 1,358 and 806, respectively, for LTG. The respective ratios of males and females prescribed CBZ and LTG in the NDB were 46.2 and 53.8%, and 56.3 and 43.7%, respectively. Both CBZ and LTG were identified as very high-risk drugs associated with extreme skin reactions such as drug-induced hypersensitivity syndrome (DIHS), toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), erythema multiforme type drug eruption (EM), and disseminated papuloerythematous drug eruption (DPE). CBZ induced DIHS, EM, and DPE more frequently among elderly men (over 60 years old), whereas LTG induced these reactions in women of reproductive age.Conclusions: Elderly men prescribed CBZ and women of reproductive age prescribed LTG should be advised about extreme adverse skin reactions.
- 著者
- 駒田 富佐夫 中山 優子 高良 恒史
- 出版者
- 一般社団法人 日本医薬品情報学会
- 雑誌
- 医薬品情報学 (ISSN:13451464)
- 巻号頁・発行日
- vol.20, no.2, pp.72-80, 2018-08-31 (Released:2018-09-12)
- 参考文献数
- 18
- 被引用文献数
- 1
Objectives: The aim of this study was to investigate both the time‐to‐onset and the onset‐pattern of drug‐induced blood disorders (DIBD) following the administration of monoclonal antibody agents through the use of the spontaneous adverse reaction reporting system of the Japanese Adverse Drug Event Report (JADER) database. Methods: Data in the JADER database from April 2004 to October 2017 were downloaded from the Pharmaceuticals and Medical Devices Agency website. The DIBD dataset for monoclonal antibody agents was constructed based on the data for the drug information and adverse drug reactions. The information for the adverse drug reactions was categorized in accordance with the preferred terms of the Medical Dictionary for Regulatory Activities and included thrombocytopenia, platelet count decreased, neutropenia, neutrophil count decreased, leukopenia, white blood cell count decreased, pancytopenia, anaemia, agranulocytosis, granulocyte count decreased, granulocytopenia, and bone marrow failure. This dataset was then used to calculate the median onset times for the DIBD and the Weibull distribution parameters. Results: The median onset times of the DIBD for gemtuzumab ozogamicin, cetuximab, ramucirumab, trastuzumab, panitumumab, bevacizumab, infliximab, rituximab, trastuzumab, and ibritumomab tiuxetan (90Y) were 4, 10, 13, 14, 14, 14, 16, 16, 27, and 28 days, respectively. The Weibull distributions for cetuximab, trastuzumab, bevacizumab, infliximab, and tocilizumab were estimated to fit the early failure type profile, while those for gemtuzumab ozogamicin, ramucirumab, rituximab, and ibritumomab tiuxetan (90Y) were estimated to fit the wear out failure type profile. The Weibull distributions for panitumumab were estimated to fit the random failure type profile. Conclusions: The results of the present study clarified both the most likely time period and the onset‐pattern of DIBD that can occur in patients after the administration of monoclonal antibody agents.
1 0 0 0 OA 医薬品市販後に追加される重大な副作用の現状
- 著者
- 小林 大介 久津間 信明 中山 惠 鵜近 篤史 鈴木 暢之 佐次田 優子 遠藤 敏成 上田 秀雄 沼尻 幸彦 駒田 富佐夫 齋藤 侑也 森本 雍憲
- 出版者
- 一般社団法人日本医療薬学会
- 雑誌
- 医療薬学 (ISSN:1346342X)
- 巻号頁・発行日
- vol.28, no.6, pp.571-575, 2002-12-10 (Released:2011-03-04)
- 参考文献数
- 10
- 被引用文献数
- 2 1
When a novel additional adverse effect is reported for a marketed medicine, the medical information leaflet has to be revised to inform physicians and pharmacists of this. Pharmacists are responsible for informing patients of early warning symptoms to avoid the subsequent appearance of severe adverse effects. However, at present, patients may suffer from severe adverse events because such symptoms may remain unrecognized until the medicine is on the market. As a result, investigations to predict and prevent novel additional adverse effects of medicines are required. In this study, we investigated a novel additional adverse effect classified as a pharmacological effect based on the drug safety update (DSU). As a result, skin disorders including toxic epidermal necrolysis and Stevens Johnson syndrome, and pseudomembranous colitis have become evident as additional adverse effects of antibiotics, with a high incidence. In addition, neuroleptic malignant syndrome and aplastic anemia have also been reported as adverse effects of central nervous system agents.Therefore, it is important to provide patients with information about the early warning symptoms related to such adverse effects, even though such adverse effects are not contained in the patient information leaflet.
1 0 0 0 OA 医薬品情報学掲載論文からみた医薬品情報学に関する研究動向の解析
- 著者
- 駒田 富佐夫 中山 優子 木下 淳
- 出版者
- 一般社団法人日本医薬品情報学会
- 雑誌
- 医薬品情報学 (ISSN:13451464)
- 巻号頁・発行日
- vol.14, no.1, pp.26-34, 2012-05-31 (Released:2012-08-02)
- 参考文献数
- 18
Objective: We analyzed articles in the Japanese Journal of Drug Informatics with the goal of identifying recent research trends in drug informatics.Method: The appearance frequencies of keywords in the Japanese Journal of Drug Informatics (2001: vol. 3 (1) to 2009: vol. 11 (4)) and Japanese Journal of Pharmaceutical Health Care and Sciences (2009: vol. 35 (1) to (6)), and words in abstracts in Japanese Journal of Drug Informatics (2009: vol. 11 (1) to 2010: vol. 12 (4)) were analyzed. Results: To investigate keywords in the Japanese Journal of Drug Informatics, appearance frequencies of information, drug, drugs and pharmacist in 2001: vol. 3 (1) to 2003: vol. 5 (4), those of information, drug, drugs, medical, medication and questionnaire in 2004: vol. 6 (1) to 2006: vol. 8 (4), and those of information, drug, questionnaire, survey, pharmacist, adverse and generic in 2007: vol. 9 (1) to 2009: vol. 11 (4) were higher than those of other keywords. In the Japanese Journal of Pharmaceutical Health Care and Sciences, appearance frequencies of drug, pharmacy, care, patient, pharmaceutical, cancer, education, training, analysis and drugs were higher than those of other keywords. Information, drug(s), patients, pharmacists, hospital, use, questionnaire, medical, adverse, survey, agents, generic and pharmaceutical were high frequency words used in abstracts published in the Japanese Journal of Drug Informatics. These words in abstracts indicate a Zipf’s law-like rank distribution. Co-occurrence network graphs using abstracts showed that the first cluster consisted of medical, drug, adverse, drugs, pharmaceutical, hospital, doctors, contents and drug around information and pharmacists as hubs, and the second cluster consisted of 3 words (agents, woman and pregnant). Furthermore, co-occurrence network graphs indicated that care, medical, pharmaceutical, information, adverse, pharmacists, hospital, doctors, questionnaire, woman, pregnant, package and side were matters of important arguments and/or phenomena.Conclusion: These data suggest that the scope of themes in articles published in the Japanese Journal of Drug Informatics is establishing definitive categories. The recent themes and contents of the Japanese Journal of Drug Informatics were closely and mutually related.