1 0 0 0 OA 2.市場撤退薬の諸相
- 著者
- 津谷 喜一郎
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.40, no.1, pp.7-16, 2009 (Released:2009-03-20)
- 参考文献数
- 7
- 被引用文献数
- 2 4
The burden of adverse drug reaction (ADR) is not limited to morbidity and mortality. It also causes healthcare burden as measured by direct cost of hospitalization, etc. as well as economic burden including indirect cost of labor loss and the withdrawal of drugs from the market. It inflicts additional burden on healthcare resources because of litigations that often ensue in cases of serious ADR. Drug withdrawal can be very costly for the companies involved. Since the 2000s, pharmacogenetics has attracted attention as a means of preventing ADRs. The Council for International Organizations of Medical Sciences (CIOMS) published a report on pharmacogenetics in 2005. The Committee to review cases of “Yakugai” hepatitis in Japan and the regulation aimed at preventing its recurrence was established in association with Ministry of Health, Labor and Welfare (MHLW) in May 2008. This paper reviewed the various research on drug withdrawal conducted in the UK and the rest of the world, the US, and Japan. Several litigation cases were introduced. Four preventive measures were discussed, i.e. 1)use of pharmacogenetics in preventing ADRs, 2)use of economic Darwinism by providing longer exclusivity periods to those drugs proven to be safe through long-term clinical trials, etc., 3)use of private or foreign drug review agency as well as margin and insurance systems, and 4)voluntary marketing suspension of drugs with questionable safety profile initiated by pharmaceutical companies.
1 0 0 0 OA 医療機関における医薬品の採用と適正使用に関する調査 2015
- 著者
- 此村 恵子 金井 紀仁 上田 彩 草間 真紀子 赤沢 学
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.47, no.5, pp.189-199, 2016-09-30 (Released:2016-12-16)
- 参考文献数
- 18
- 被引用文献数
- 1
Objective: A policy survey regarding the development of hospital formulary and promotion of appropriate drug use in hospital settings was conducted.Methods: We have conducted a similar survey every five years since 2000 to monitor hospital policy changes. This year, we selected 500 hospitals with 200 or more beds from a list of 2,583 national hospitals for 2015. A stratified random sampling method was used to identify 250 hospitals that adopted the diagnosis procedure combination (DPC)-based payment system and those that did not (250 non-DPC hospitals). Questionnaires consisting of eight items were posted to individuals who had primary responsibility of drug management, during a study period from November 2015 to January 2016.Results: A total of 175 responses was returned (overall response rate 35%), with response rates of 42% for DPC hospitals and 28% for non-DPC hospitals (including general and mental hospitals). Inclusion of generic drugs in hospital formulary increased by 10 points from 10% in the 2010 survey. Approximately 85% of the hospitals developed their own formulary lists. According to the responses, the most important factors to select formulary drugs were effectiveness, safety, novelty, quality, formulation, price and cost-effectiveness. This trend was almost the same as that reported in the 2010 survey. Eighty-nine percent of DPC hospitals, 73% of general hospitals, and 45% of mental hospitals had specific criteria to select formulary drugs. Many hospitals reported that generic drugs were added to the formulary immediately after they became available in the market.Conclusion: The results of this survey suggested that many hospitals became more cost-conscious due to social pressure of cutting medical expenditure. The findings that many hospitals already developed formulary lists, had standardized formulary review process, and switched to generic drugs showed increased awareness of appropriate drug choices and uses. However, very few hospitals introduced cost-effectiveness analysis in the review process, and it might take time before this analysis becomes commonly used.
1 0 0 0 OA ヒト肝ミクロソームおよび遺伝子組換えヒトCYP発現系によるエトポシドの代謝
- 著者
- 河城 孝史 山下 幸和 Xue-Jun Zhao 小山 恵理子 谷 昌尚 千葉 寛 石崎 高志
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.28, no.1, pp.175-176, 1997-03-31 (Released:2010-06-28)
- 参考文献数
- 3
1 0 0 0 OA 2. 虎の門病院「妊娠と薬相談外来」の経験から
- 著者
- 林 昌洋
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.37, no.6, pp.331-337, 2006-11-30 (Released:2010-06-28)
- 参考文献数
- 3
1 0 0 0 OA ウコン (Curcuma) 属生薬のヒト肝CYP代謝活性への阻害効果
1 0 0 0 OA CHDF施行患者におけるミカファンギン体内動態に関する検討
1 0 0 0 フレカイニド内服中に心停止をきたした高齢担癌患者の1例
- 著者
- 小西 寿子 志賀 剛 瀬下 明良 木村 利美
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.49, no.4, pp.169-172, 2018-07-31 (Released:2018-08-22)
- 参考文献数
- 8
- 被引用文献数
- 1
症例は83 歳,男性.経皮的冠動脈形成術後に伴う心室期外収縮に対してフレカイニド 50 mg 1回 1錠 1日 2 回で服用していた.中部胆管癌を併発し,食事摂取量が減り,体重も減少した.他院でビタミン C 大量静注中に心肺停止を来し,心肺蘇生により心拍再開を得た.当院救急搬送後,心電図にてQT 間隔の延長 (0.76秒) を認め,フレカイニドを中止した (血中フレカイニド濃度は治療域であった) .さらに血清カリウム値が 2.0 mEq/L,血清アルブミン値が 2.7 g/dL と低値であったため,カリウム製剤による補正を行うとともにヒト血清アルブミン製剤 25 g/日の投与と中心静脈栄養を併用することで血清カリウム値も改善し QT 間隔が正常化した.本例では食事摂取不良による低栄養から低カリウム血症を来し,フレカイニドによる QT 延長作用が増強し心停止に至ったと考えられた.
- 著者
- 安 隆則
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.40, no.4, pp.171S-172S, 2009 (Released:2009-10-15)
- 参考文献数
- 10
1 0 0 0 OA 慢性気道炎症とマクロライドの新作用
- 著者
- 工藤 翔二
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.29, no.3, pp.539-540, 1998-05-31 (Released:2010-06-28)
- 参考文献数
- 4
1 0 0 0 OA 3.WarfarinとCYP2C9,VKORC1遺伝子多型
- 著者
- 高橋 晴美
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.39, no.6, pp.243-246, 2008 (Released:2009-03-01)
- 参考文献数
- 11
Warfarin is the mainstay of anticoagulation therapy, worldwide. Its clinical use, however, is complicated by the fact that it has a narrow therapeutic index with potential bleeding complications. The dosage requirement of warfarin to produce therapeutic anticoagulation varies widely among patients. Recently genetic factors such as the CYP2C9 and VKORC1 genes have been demonstrated to be determinants of warfarin response. CYP2C9 is the enzyme primarily responsible for the metabolic clearance of the S-enantiomer of warfarin. VKOR is the target protein of warfarin which recycles the reduced form of vitamin K, an essential cofactor in the formation of the vitamin K-dependent clotting factors. There is strong evidence to support an association between these genetic variants and therapeutic doses of warfarin. On the basis of these observations, the Food and Drug Administration (FDA) approved a labeling change for warfarin that includes the genetic information of VKORC1 and CYP2C9 as factors influencing inter-individual variability in warfarin dosing. The package insert as of August 2007 states that “lower initiation doses should be considered for patients with certain genetic variations in CYP2C9 and VKORC1 enzymes.” The FDA also approved clinical tests for these genetic variants. However, at present, a validated dosing algorithm, evidence of the clinical utility of genotyping and a reliable economic analysis are not availabie to recommend routine CYP2C9 and VKORC1 testing in every patient before the initiation of warfarin. The results of several randomized prospective controlled trials conducted to test the impact of genotype-guided warfarin dosing in Caucasian and Asian patients are shown in this review.
1 0 0 0 5.日本人小腸におけるチトクロームP450(CYP)分子種の発現
1 0 0 0 OA FD-1の活性化と生体内動態に関する実験的および臨床的知見
- 著者
- 竹内 和彦 渡辺 裕司 Tran Quan-Kim 楊 軍 小菅 和仁 寺田 肇 大橋 京一
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.32, no.1, pp.27S-28S, 2001-01-31 (Released:2010-06-28)
1 0 0 0 OA 1.抗血小板薬とその作用機序
- 著者
- 西川 政勝 田丸 智巳
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.40, no.6, pp.253-260, 2009 (Released:2009-12-25)
- 参考文献数
- 28
- 被引用文献数
- 1 1
Antiplatelet drugs belong to the class of pharmaceuticals that inhibit platelet activation and thereby suppress arterial thrombus formation. They are widely used for primary and secondary prevention of atherothrombotic diseases including coronary heart diseases, ischemic strokes and peripheral arterial diseases. These drugs are broadly classified into two categories: (1) inhibitors of the platelet activation signal-transduction system, and (2) stimulators of production of inhibitory signals such as cAMP and cGMP. The first category comprises ADP receptor (P2Y12) antagonists including ticlopidine, clopidogrel and prasugrel; the serotonin 5-HT2 receptor antagonist sarpogrelate; the cyclooxygenase-1 inhibitor aspirin; and eicosapentaenoic acid. The second category comprises prostacyclin analog, the cyclic nucleotide phosphodiesterase (PDE)-3 inhibitor cilostazol, and the PDE-5 inhibitor dipyridamole. Drugs in the second category stimulate vasodilation, as well as inhibit platelet aggregation. Current clinical trial evidence favors the use of aspirin, clopidogrel and cilostazol as first-line agents in the majority of patients with vascular disease. Clinical trials evaluating novel antiplatelet drugs will impact the direction of future practice.
1 0 0 0 OA 薬物による血液学的副作用の発現
- 著者
- 長村 重之
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.2, no.1, pp.36-40, 1971-01-30 (Released:2010-06-28)
- 参考文献数
- 12
1 0 0 0 OA 座長のまとめ
- 著者
- 梅村 和夫 和田 孝一郎
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.42, no.2, pp.63-64, 2011 (Released:2011-06-30)
1 0 0 0 OA 4.TGN1412事件の倫理的問題点:薬事規制による被験者保護の限界
- 著者
- 栗原 千絵子
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.39, no.4, pp.113S-114S, 2008 (Released:2009-02-04)
- 参考文献数
- 8
1 0 0 0 OA 累積二項確率の能率的算出法
- 著者
- 栗谷 典量
- 出版者
- 一般社団法人 日本臨床薬理学会
- 雑誌
- 臨床薬理 (ISSN:03881601)
- 巻号頁・発行日
- vol.10, no.1, pp.69-70, 1979-03-30 (Released:2010-06-28)
