著者
小室 雅人 折井 啓一郎 小野寺 祐加 白神 誠
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.15, no.3, pp.111-117, 2013 (Released:2013-12-27)
参考文献数
6

Objective: If product information provided by pharmaceutical manufactures is not consistent with a product assessment made by the Pharmaceuticals and Medical Devices Agency (PMDA), users may gain false perceptions about the product, which may be detrimental to patients.  An investigation was conducted to compare the contents of product information provided by pharmaceutical manufacturers and product evaluation reports prepared by PMDA to identify any discrepancies between data assessment in the two documents.Methods: Descriptions in “Product Characteristics” and “Clinical Studies” of product information summaries were compared with product evaluation reports prepared by PMDA.  Inquiries were addressed to manufacturers if any questions arose.Results: The investigation was conducted on 66 new active ingredients approved in 2009 to 2010.  As 14 questions arose with 12 ingredients, inquiries were addressed to manufacturers, all of whom offered a response.  As a result, four questions were resolved for two ingredients.  However, for the remaining products, it was revealed that the manufacturers described in the product information summaries what they claimed at the time of submission even though their claims were not accepted by PMDA.Conclusion: It was considered that the pharmaceutical manufacturers possibly did not comprehend the contents of the PMDA’s evaluation reports.  It was suggested that the industry as a whole should examine the issue.  As discrepancies were observed even in product information summaries, which are viewed by a relatively large number of people, it was assumed that more issues may be found in promotional materials provided exclusively to healthcare professionals.
著者
中島 理恵 白神 誠
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.37, no.1, pp.9-18, 2018-06-10 (Released:2018-07-10)
参考文献数
14

When establishing new pharmacy services, they must be in line with the needs of individual community residents. In our research, it was clear that services provided by the newly implemented health support pharmacies and primary care pharmacist system in recent years satisfy the needs of patients as well as the public in general. We collected information via a survey that used a structured questionnaire. In addition to basic information (age/sex), it also covered details of their pharmacy use, their thoughts on pharmacy services, and the actual usability of pharmacy services. Differences in respondent’s opinions and the actual usability of each pharmacy service were compared between age groups and sexes. Female respondents had more favorable opinions about the antismoking, nutrition, and sickness prevention consultation services than male respondents did. The proportion of survey respondents in their 40s and 50s who proactively used pension and welfare consultation services was significantly higher than for other age groups. The younger generation perceived 24-hour pharmacies and the primary care pharmacy system as necessary. There is a large disparity between people’s thoughts and opinions on the actual usability of the services that primary care pharmacies aim to offer, and this differ in people’s ages and sexes. The younger generation tend to expect the pharmacy services. It is important for pharmacies to address the needs of the generation which is skeptical toward the separation of medical and dispensary practice and recognize them the new role of pharmacies.
著者
伊勢 雄也 萩原 研 齋藤 節生 本城 和義 宋 静香 加藤 あゆみ 片山 志郎 西澤 健司 平野 公晟 吉行 俊郎 木山 輝郎 三橋 恭子 亀井 美和子 白神 誠
出版者
公益社団法人日本薬学会
雑誌
藥學雜誌 (ISSN:00316903)
巻号頁・発行日
vol.124, no.11, pp.815-824, 2004-11-01
被引用文献数
1 1

米国では1983年よりMedicareの入院医療費の支払い方法として,医療費の診断群別定額支払い制度(Diagnosis Related Group/Prospective Payment System;DRG/PPS)が導入されているが,わが国でも平成15年4月より診断群分類(Diagnosis Procedure Combination;DPC)に基づく包括支払い制度が大学病院,国立がんセンター,国立循環器病センターなどの特定機能病院計82施設での入院医療において開始された.その結果,入院患者の在院期間の短縮と入院費用の削減並びに患者満足度の向上などを目的として,クリニカルパス(Clinical Pathway;CP)が日本の医療においてさらに注目されるようになった.日本医科大学付属病院(以下「当院」という)では1998年に「CP研究会」が設立され,患者ケアを医療スタッフがチームとなって行うシステムの構築を検討してきた.1)薬剤部では,その中でも胃癌の切除術患者CPに積極的に携わり,同CPに薬剤管理指導業務を導入することによる有用性並びにその費用対効果についての検討を行い,数多くの知見を得ている.
著者
藤田 優子 中島 理恵 小野寺 祐加 白神 誠
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.16, no.1, pp.23-27, 2014-05-30 (Released:2014-06-09)
参考文献数
3

Introduction: A health assessment sheet was developed to establish a new method for post marketing surveillance (PMS) for nonprescription drugs, the status of which has recently been switched from prescription (Rx) to over-the-counter (OTC) to confirm the efficacy and safety of Rx-to-OTC switched drugs.  The assessment sheet was designed to evaluate adverse reactions that may be possibly induced by the drugs and to elicit spontaneous complaints from consumers.  An investigation using the assessment sheet had been conducted earlier for famotidine tablets.  While the earlier investigation suggested the effectiveness of the assessment method, it also revealed some issues.  After making improvements in the assessment sheet, another investigation was conducted for Loxonin®S.Method: Purchasers of Loxonin®S were asked to tick symptoms that were applicable to them among those listed in the sheet.  They were asked to revisit the pharmacy and complete the sheet for the second time after drug administration.  The possibility of adverse reactions was considered for the symptoms additionally chosen at the second visit and they were then compared with the adverse reactions described in the package insert of Loxonin®S.Results: Total 284 people completed the health assessment sheet at their first and second visits.  Of them, 44 people (15.5%) reported additional symptoms at the second visit.  Commonly reported symptom was “frequent experience of sleepiness,” “persistent headaches” and “fatigability.”Conclusion: The study suggested that the health assessment sheet can be an effective tool for PMS for nonprescription drugs immediately after the Rx-to-OTC switch and contributes to detecting adverse reactions of the drugs.
著者
伊勢 雄也 恩田 光子 三浦 義彦 島崎 真知子 川田 佳子 萩原 研 片山 志郎 菊池 有道 亀井 美和子 小林 宏司 白神 誠
出版者
公益社団法人日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.127, no.6, pp.1021-1025, 2007 (Released:2007-06-01)
参考文献数
9
被引用文献数
2 4

The contents of pharmacist interventions, which were carried out by the ward pharmacists in their routine pharmacy service activities, were sorted and analyzed to evaluate the contributions of pharmacists. In the ward where pharmacists were stationed, there were a total of 196 cases of pharmacist intervention. The prescription was changed in 170 cases, giving a rate of prescription change of 86.7%. The breakdown of the pharmacist intervention was as follows: “efficacy/safety”, 106 cases, followed by “dosage regimen” (48 cases) and “compliance” (10 cases). Cost savings achieved during the investigation period were calculated to be 440,639 yen, and cost avoidance was valued at 1,941,847-3,883,695 yen using the Diagnosis Procedure Combination (DPC). The results of the present investigation showed that pharmacists contribute to through not only their pharmacy services, but also through the promotion of proper drug use and risk management, thereby contributing to hospital management through cost savings and avoidance.