著者

鹿村 恵明 田中 愛佳 根岸 健一 下平 秀夫 若林 進 塚原 俊夫 野村 香織 出石 啓治 宮崎 長一郎 望月 眞弓 上村 直樹

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.18, no.4, pp.242-250, 2016-02-28 (Released:2017-03-17)

参考文献数

18

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Objective: For effective use of over-the-counter (OTC) drugs that are provided as relief supplies during a disaster, we aimed to develop a list of OTC drugs that can be used during a disaster.Methods: We obtained information about OTC drugs useful during a disaster by examining results of previous studies and lists of drugs used during a disaster.  We analyzed this information with the expert pharmacist of disaster support and established a rationale for our list and developed “the List of Useful OTC Drugs During a Disaster” and “the Information Card on Useful OTC Drugs During a Disaster.”Results: We developed our list of OTC drugs based on the following parameters: (1) while people with severe disorders (e.g. renal failure) are treated by medical teams, those with minor physical conditions are treated using OTC drugs and (2) those OTC drugs that can be used as substitutes for prescription drugs were preferably selected.  The List of Useful OTC Drugs ()—During a Disaster (containing 56 items) was developed for use mainly by medical professionals.  Further, pharmacists from disaster-relief medical teams may not always be available in disaster-stricken areas; therefore, the Information Card on Useful OTC Drugs During a Disaster was developed to enable disaster victims to independently make a certain level of decision.  The information card contained pictograms to call the attention of the disaster victims.Conclusion: Our results can provide a common tool for drug suppliers, medical professionals engaging in relief works in disaster-stricken areas, and disaster victims.

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

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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

山本 晃之 上村 直樹

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.18, no.4, pp.295-300, 2017 (Released:2017-03-17)

参考文献数

10

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Objective: The dispensing fee revision of April in 2016 made a review of the assessment of inquiries about prescriptions.  The requirement was added by articles that seemed to be pharmaceutically necessary, showing an increase of responsibility for pharmacists.  Based on this, we performed a discussion while collecting the cases of inquiries about prescriptions.Method: Among the inquiries about prescriptions performed at Jinjo Pharmacy for 4 months starting from April in 2016, we selected 83 cases where a prescription was changed by the pharmacist’s recommendation, based on pharmaceutical information such as drug duplication or drug interaction and confirmation of leftover medicine.  Then, we compared them with the study of inquiries about prescriptions performed by the Japan Pharmaceutical Association in 2015.Result/Consideration: Inquiries about dose were the leading content, followed by those about duplication with other drugs of same indications and appropriateness of dose considering the adjustment of number of days due to residual drug, which showed the importance of medicinal history and prescription records.  It is considered necessary to renew the contents of the prescription record properly, based on the information acquired, while at the same time changing the pharmaceutical history based on those records.  It is thought that an inquiry about prescriptions will be performed appropriately by making a judgment based on such information. In order to do that, updated knowledge about medicine and updated information about drugs is necessary.  In comparison of the two studies, both showed that the drug information on “safety” and “dose and dose regimen” accounted for a large part of inquiries.  Further consideration on them will be necessary.

著者

奥村 康子 小田 雅子 齊藤 浩司

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.17, no.1, pp.34-38, 2015 (Released:2015-06-28)

参考文献数

9

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Objective: Consultation contents from medical consumers can become a useful information for medical workers.  However, report which investigated about them is limited.  In this study, we investigated the question contents from medical consumers with telephone.Methods: Nineteen hundred records on the consultation from medical consumers with telephone from 2007 to 2011 were subject to this study.  Using appropriate keywords and check the records, corresponding cases were extracted.Results: Resources of drug information which medical consumers used had various one such as the Internet, television, books, and newspapers.  However the medical consumers did not necessarily understand drug information correctly from the Internet and books.  This means that support by pharmacists was necessary in those cases.Conclusion: We think that information sharing in the medical consumers and medical workers based on a good relationship is important for proper use of drugs.

著者

中島 誠 中木原 由佳 高橋 武士 野間口 寛 寺師 守彦 林 秀樹 杉山 正

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.18, no.1, pp.13-21, 2016 (Released:2016-06-13)

参考文献数

19

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Objective: We have used therapeutic drug monitoring (TDM) analysis software to set the initial dose of vancomycin in our hospital.  In contrast, the TDM guideline, in which the initial dose of vancomycin per body weight was set, was published in 2012.  We looked forward with utilizing the TDM guideline in the clinical setting, after which we conducted multiple surveys to determine the important points of the TDM guideline.Methods: We surveyed patients treated with vancomycin, in whom the initial dose was set using the TDM analysis software and the concordance rate between the vancomycin dose set with the software and that set with the TDM guideline.Results: The concordance rate of vancomycin dose was 42.1%.  The mean age of the high-dose group (vancomycin dose higher than that recommended by the TDM guideline), was younger than that of the recommended-dose group.  Additionally, the mean body weight of the high-dose group was significantly lower than that of the recommended-dose group.  The corrected creatinine clearance of the low-dose group was significantly lower than that of the recommended-dose group.Conclusion: Our results suggest that when the initial dose is set after referring the TDM guideline in patients who are not very high age, and having low body weight and decreased renal function, the dose may differ from the dose set by using TDM analysis software.  In addition, since the recommended dose per body weight is a range and not a single value, setting the dose appropriate to target trough concentration is necessary.

著者

成井 浩二 田淵 照人 渡邉 捷英 渡辺 謹三

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.17, no.4, pp.209-216, 2016-02-29 (Released:2016-03-19)

参考文献数

8

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Objective: An external training seminar was held for registered salesclerks of drugs to help them keep and improve their knowledge of drugs.  To promote self-medication and to enhance the content of training seminars, we collected data in the form of inquiries the clerks had received from customers and what information the clerks sought from drug companies.Methods: Our survey was conducted with 199 registered salesclerks of drugs at an external training seminar in Tokyo, Japan.Results: The main inquiries from customers to the registered salesclerks were “selection of an analgesic for headache” (83.8%), “selection of an analgesic for cramps” (62.3%), and “selection of an analgesic for toothache” (57.7%).  The main information that they sought from drug companies were “side effects,” “interaction between drugs,” “time of onset of action,” and “degree of effect of drugs.”Conclusions: To respond to the inquiries from customers, it was necessary to supply the clerks with knowledge of pharmacokinetics in the external training and to supply them with information on side effects, interaction between drugs, time of onset of action, and degree of effect of drugs on individual products from drug companies.  Additionally, this information and knowledge of drugs can be gained from not only the external training and drug companies but also from pharmacists they work with.  It was thought that continuing the external training seminars and input of information from drug companies led to levels similar to a pharmacist and the registered salesclerks contributed actively to promoting self-medication.

著者

大嶋 繁 小田 藍 根本 英一 土橋 朗 小林 大介 齋藤 侑也 白幡 晶

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.11, no.2, pp.66-75, 2009-11-30 (Released:2010-05-12)

参考文献数

9

被引用文献数

1

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Objective : There are two types of studies on the relationship between adverse events and genetic background and the relationship between constitution and genetic background.  To investigate the relationship between adverse events and constitution retrospectively, we first reviewed the appearance of the constitution responsible for the adverse events in the relevant sources of information.Methods : Fifty two pharmaceutical interview sheets, 150 case reports and two manuals; “jyudaina fukusayou kaihi notameno fukuyaku sidou jyouhousyu”, “jyutoku fukusayou sikanbetu manual” were selected for review.Results : Fourteen items about the constitution were found in the pharmaceutical interview sheets.  No items about the constitution were found in the case reports and manuals.Conclusion : Rules for the preparation of pharmaceutical interview sheets and case reports to use the constitution information is necessary for retrospective analysis of this issue.

著者

川名 真理子 小堀 裕果 中崎 允人 鈴木 正論 永井 淳子 佐々木 忠徳

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.105-110, 2013 (Released:2013-12-27)

参考文献数

7

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Objective: There are only a few studies evaluating the effects of drug information services on pharmacotherapy.  We, therefore, studied the effects of providing drug information such as the effectiveness and safety of aliskiren on its pharmacotherapeutic efficacy by comparing before versus after drug information provision.Methods: Pharmacists provided drug information such as the effectiveness and safety of aliskiren coadministered with either ACE-I (angiotensin converting enzyme inhibitor) or ARB (angiotensin receptor blocker) to physicians and other healthcare professionals.  We compared the number of patients for whom aliskiren was prescribed, the proportion of diabetic patients taking both aliskiren and ACE-I (or ARB), the proportion of patients with low eGFR (estimated glomerular filtration rate), and the proportion of patients with hyperkalemia and related conditions, before versus after providing the drug information to the healthcare professionals.Results: The number of patients for whom aliskiren was prescribed decreased.  The proportion of patients taking both aliskiren and ACE-I (or ARB) decreased significantly after providing the drug information (p=0.007).  The proportion of diabetic patients taking both aliskiren and ACE-I (or ARB), the proportion of patients with low eGFR, and the proportion of patients with hyperkalemia also decreased, after providing the drug information.Conclusion: This study showed the drug information service to be clinically beneficial, achieving better pharmacotherapy.  Pharmacists should evaluate and provide information on the effectiveness and safety of drugs announced by authorities in a timely manner to achieve optimal patient care.

著者

岡本 有紀子 服部 慈久 中村 康夫 紙本 薫 鈴村 宏

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.17, no.2, pp.59-68, 2015 (Released:2015-10-01)

参考文献数

19

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Objective: Incidents, such as disturbance of consciousness due to adverse reactions of medications during automobile driving, could cause a serious accident.  Although automobile driving is indicated to be “prohibited” in the package inserts of many drugs, no explicit guidelines are available in Japan on specific guidance to patients.  Therefore, we attempted to prepare guidelines for medication guidance regarding automobile driving.Methods: We investigated the number of incidents involving traffic accidents and the disturbance of consciousness cases reported in “Japanese Adverse Drug Event Report” database by “Pharmaceuticals and Medical Devices Agency (PMDA).”  We also analyzed descriptions regarding automobile driving found in package inserts and guidelines to determine a risk level for each medication.Results: Guidelines for medication guidance were prepared based on four-level classification of drugs for which “prohibition” of automobile driving was indicated in their package inserts; these levels are “conform to pertinent guidelines,” “strictly prohibited,” “prohibited,” and “conditionally prohibited.”  The contents of the guidance prepared for some drugs were different from their package inserts.Conclusions: The guidelines prepared in this study can be expected to become a support tool to ensure close attention to cautions regarding automobile driving.  Because some contents of the guidance are different from that described in the package inserts, it is desirable to obtain agreement with physicians in hospitals adopting these guidelines.  In addition, guidelines based on a broader range of information should be prepared in the future.

著者

桐生 嘉浩 本間 直美 吉野 多栄子 村井 ユリ子 祖父江 展 佐藤 良智

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.1, pp.8-16, 2017-05-31 (Released:2017-06-16)

参考文献数

13

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Objective: Numerous new drugs have been developed in recent years, making the available types of prescription drugs quite diverse, with increasingly more complex drug interactions.  From an operations support system perspective, hospitals that cannot incorporate a large-scale custom-order system because of financial or use-efficiency limitations have no choice but to rely on commercial products.  However, this leaves many problems unsolved, such as functional restrictions and limited specifications.  In this study, we used Microsoft®Visual Basic®for Application (VBA) to develop an economical drug discrimination system suited to our situation and equipped with original function from the perspective of clinical pharmacists.Design: System design and development.Methods: We prototyped the system in VBA and used Microsoft®Excel®to create Query Tables.  The utility of the new system was evaluated based on drug discrimination output and time required in each process.Results: The new system is capable of inter-database communication and automated data analysis and uses drop-down lists of pre-defined options for data input in many places.  Compared with the conventional method, the new system enabled us to significantly reduce the average time needed to input and confirm data by as much as 61.9%.  This indicates that the new system can considerably reduce the time required for completing time-intensive processes and is also useful in preparing highly precise drug discrimination reports.Conclusion: Based on the results obtained so far, the new, original system, developed with zero design or development costs, is more efficient and offers more reliable information in the clinical setting than the conventional system.  As a result, we are able to maintain operational quality and reduce the amount of time required for drug discrimination.

著者

村上 雅裕 桂木 聡子 行廣 佳奈 大野 雅子 天野 学 森山 雅弘

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.17, no.3, pp.133-139, 2015 (Released:2015-12-18)

参考文献数

7

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Objective: Along with the globalization of the Japanese economy, the number of international students in Japan has gradually increased.  Under these circumstances, international students to visit pharmacies for self-medication are expected to increase.  Thus, we carried out a questionnaire survey on international students conducting self-medication using non-prescription drugs, and examined its problem.Method: To clarify the status of self-medication using OTC drugs by students studying abroad, multiple-choice and free description-style questionnaire sheets written in Japanese or English were distributed to 30 international students based in Kobe City.  The sheets were independently completed by the students, excluding those who had difficulty in sufficiently comprehending the questions and required the researcher’s oral explanations for assistance.Result: While 90.0% of the respondents answered that they occasionally use non-prescription drugs in their own countries, only 60.0% answered that they had experience of purchasing the drugs in Japan.  When purchasing OTC drugs, 15.2% faced <difficulty in reading> instructions printed on their packages.  While 30.0% regarded <pharmacists’ advice> as important to purchase appropriate drugs in their home countries, only 23.3% sought such advice in Japan.Conclusion: These results revealed a tendency for international students to purchase OTC drugs following pharmacists’ advice less frequently in Japan than in their home countries despite their literacy difficulties.  In the future, we hope to examine issues such as possible active communication by pharmacists and the drugstore structure, so as to promote self-medication through purchasing drugs at Japanese pharmacies.  As a result, we hope to contribute to making Japanese pharmacies more foreign user-friendly in a real sense.

著者

飯嶋 久志 大澄 朋香

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.18, no.1, pp.22-32, 2016 (Released:2016-06-13)

参考文献数

104

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Objective: Clinical articles are important for individualization of drug therapy.  Especially, meta-analysis is positioned at the highest evidence level.  Therefore, we assessed the Quality Score of Meta-Analysis (QSMA) which provides simple assessments of both the quality and the format of meta-analyses, by applying them to incretin-related drugs as a model.  Furthermore, we attempted to extract clinical data from the literature employing a certain minimum standard.Method: We searched for meta-analyses of incretin-related drugs for diabetes in PubMed and the Cochrane Library, scoring the extracted articles for format using PRISMA statements, and for quality using QSMA.  Additionally, we classified these articles into two groups with a QSMA score of 70% as the basis, and verified the analysis sets (ITT, FAS, PP or APT) and sensitivity analysis.  Furthermore, we looked into those articles that scored 70% or higher to extract data that were deemed to have significant statistical differences.Results: Scoring of the 66 articles studied yielded 69.9±19.4% (mean ± SD) for format and 62.1±17.8% for quality.  These two variables produced a regression line of y=0.777x+7.834.  Comparison of the two groups classified on the basis of a 70% score on QSMA yielded a significant difference in sensitivity analysis only (p<0.05).  Seven effects and five side effects were extracted from articles with a QSMA score of 70% or higher.Conclusion: Although QSMA can provide simple assessment of quality and structure using eight items, analysis sets needs to be verified individually.  As the articles assessed provided statistically endorsed data, the clinical application of QSMA will be an issue in the future.

著者

松山 賢治

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.18, no.1, pp.N1-N5, 2016-05-31 (Released:2016-06-13)

著者

倉田 佳奈 高橋 由佳 岩崎 后穂 朴 京子 小山 慎一 日比野 治雄 山下 純

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.18, no.4, pp.223-234, 2016-02-28 (Released:2017-03-17)

参考文献数

9

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Objective: Instructions contained in over-the-counter medicine package inserts can be hard to read because of the limited printing space.  Pictograms are one means of helping users to understand important information.  However, few pictogram systems have been reliably and validly evaluated.  Therefore, a new method was developed to improve the clarity of each illustration and the legitimacy as a pictogram for conveying information important.Methods: Four creators developed 69 illustrations, each of which expressed one of 24 instructions in the package insert of an H2 blocker.  In a survey, participants (449 university undergraduate and graduate students and 103 pharmacy users) were asked to describe the possible meaning of each illustration and to provide their personal suggestions for improvement.  To evaluate comprehension of information, each instruction was broken into two or three different parts.  Comprehension level was calculated by: (number of people who answered correctly) × 100 / (total number of respondents).  Existing pictograms were included to compare comprehension levels for the same instructions.Results: Using 67% as the minimum standard for comprehension, we classified each illustration into one of three categories: “no need for improvement,” “need for partial improvement,” and “need for total improvement.”  The students and pharmacy users tended to accurately interpret the possible meanings of illustrations that were familiar to them.Conclusion: Breaking one instruction of the package insert into a few important pieces of information was useful for determining the level of improvement needed for each illustration.  Evaluating how well each illustration conveys important information in the instructions through two steps was also beneficial, which are to improve the illustration’s clarity with students and its legitimacy among pharmacy users for fulfilling the intended functions of a pictogram.

著者

江戸 清人 安藤 崇仁

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.18, no.4, pp.N1_2-N4, 2017 (Released:2017-03-17)

参考文献数

16

著者

江角 悟 佐藤 智昭 黒田 智 河崎 陽一 名倉 弘哲 北村 佳久 千堂 年昭

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.18, no.2, pp.72-80, 2016 (Released:2016-09-27)

参考文献数

15

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Objective: In drug treatment for pregnant and lactating women, pharmacists need to contribute to adequate drug treatment by collecting much information from various sources.  However, it takes much time to collect information using plural sources.  In this study, we tried to develop a database system which enables expeditiously collecting the domestic and foreign drug use criteria information in order to streamline collecting information for pregnant and lactating women.  In addition, we assessed the utility of the database by comparing the time to collect information using the database to that using each information source and the usability by questionnaires.Methods: We developed a database system that integrates drug information from the FDA Pregnancy Category, Australian categories for prescribing medicines in pregnancy, “Drugs in Pregnancy & Lactation,” and Japanese package inserts.  For assessment of the usability of the database, we assessed the time required to collect information and subjective evaluation using the five-method questionnaires.Results: The database significantly reduced the time needed for collecting criteria information and made it possible to compile the information simultaneously from various sources.  The questionnaire survey showed that over 80% of pharmacists and students were satisfied with the database.Conclusion: It is suggested that our database system is useful to efficiently collect drug use criteria information for pregnant and lactating women.

著者

野口 義紘 齊藤 康介 江崎 宏樹 臼井 一将 加藤 未紗 舘 知也 寺町 ひとみ

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.17, no.4, pp.192-198, 2016 (Released:2016-03-19)

参考文献数

29

被引用文献数

3

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Objective: Antiplatelet therapy is useful for infraction prevention.  But, in elderly patients, adverse events are easily observed, owing to the decrease in metabolism and excretion of drugs.  Furthermore, applying guidelines for medical care of each disease does not necessarily result in good conclusions.  Therefore, we used Japanese Adverse Drug Event Report database and assessed safety signals with signal detection about adverse events developed by the antiplatelet therapy in the elderly patients.Methods: We analyzed all adverse events reported on ticlopidine hydrochloride that should be carefully administered, and clopidogrel, bisulfate and aspirin that are recommended as the alternative drugs.  We used the proportional reporting ratio for a safety index of drugs.Results: While some adverse events were expressed in only ticlopidine hydrochloride, bleeding signal was detected in all the subject agents.  In addition, onset risk of ticlopidine hydrochloride was found to be the lowest value.  Moreover, adverse events expressed in clopidogrel bisulfate and aspirin were of a wide-variety compared with ticlopidine hydrochloride.Conclusion: It is necessary to carefully administer not only ticlopidine hydrochloride but also the alternative drugs to the elderly patients as indicated, and there is a need to pay careful attention to administration of the alternative drugs.

著者

服部 慈久 岡本 有紀子 中村 康夫 紙本 薫 鈴村 宏

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.17, no.3, pp.164-168, 2015 (Released:2015-12-18)

参考文献数

5

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Objective: When vehicular accidents occur as a result of impaired consciousness etc., because of adverse drug reactions, there is a risk that third parties may be harmed.  Till date, at Nagoya City East Medical Center (hereinafter, our hospital), the warnings about driving motor vehicles while taking drugs has varied depending on the doctor or pharmacist who provides the guidance.  Therefore, throughout our hospital, we aimed to standardize these warnings and to introduce measures to strictly enforce them.Methods: Among all the drugs used at our hospital, we identified those with warnings on the package insert about driving motor vehicles and classified them in accordance with “The Drug Administration Guidance Criteria Regarding the Driving of Vehicles,” created by our hospital on the basis of descriptions on the package insert and the level of risk of taking drugs.  We then standardized the warnings about driving motor vehicles while taking drugs, throughout our hospital.Results: Of the 1,416 drugs used at our hospital, we identified 294 (21%) with warnings about driving motor vehicles on the package insert, and more than half of these (158 drugs) had warnings about the prohibition of driving motor vehicles on the package insert.  As a result of classifying the drugs according to “The Drug Administration Guidance Criteria Regarding the Driving of Vehicles,” we identified 53 drugs with warnings about the prohibition of driving motor vehicles.  By the classification of the level of risk of taking drugs while driving motor vehicles and the hospital-wide standardization of the warnings about driving motor vehicles while taking drugs, we are now able to provide drug administration guidance in the form of warnings that are customized to the level of risk of using each drug.Conclusion: These measures have clarified the level of risk of taking each drug and warnings about driving motor vehicles while taking them.  In the future, we intend to cooperate with local pharmacies to intervene in the prescription of drugs outside well as inside hospitals.

著者

岡澤 香津子 若林 雅人 松岡 慶樹 佐々木 伸一 水越 裕樹 竹原 恵美子

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.2, pp.83-89, 2013 (Released:2013-09-05)

参考文献数

15

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Objective: The present study investigated awareness and knowledge about clinical trials among pharmacists working in the Nagano Hokushin area as well as their contribution to the enlightenment of clinical trial.Methods: A questionnaire survey of clinical trials was conducted to evaluate levels of interest, impressions, sources of information, and knowledge among hospital and community pharmacists.Results: We received responses from 77 hospital and 67 community pharmacists.  The levels of interest in clinical trials were not significantly different between hospital and community pharmacists.  About impressions, hospital pharmacists thought that clinical trials were “a new development.”  Contrarily, community pharmacists thought that clinical trials were “a field that they were seldom concerned with.”  About sources of information, hospital pharmacists found that “study meetings” were the most informative.  More community pharmacists than hospital pharmacists chose “general reports, for example, newspapers and televisions” as a source of information, and similarly more community pharmacists indicated that they had “few opportunities for obtaining information about clinical trials.”  About knowledge, the percentage of correct answers about clinical trials between hospital and community pharmacists was not significantly different.  A higher percentage of community pharmacists than hospital pharmacists answered unknown.Conclusion: Hospital and community pharmacists had different impressions and knowledge about clinical trials probably because of differences in sources of information and its access.  Henceforth, study meetings involving educational material about clinical trials should be held for discussing fundamental knowledge about the methods and structure of clinical trials and for discussing case studies wherein patients consult pharmacists about clinical trials.

著者

細見 光一 新居 万莉 藤本 麻依 高田 充隆

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.17, no.1, pp.15-20, 2015 (Released:2015-06-28)

参考文献数

47

被引用文献数

1

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Objective: Signal detection by analyzing adverse event spontaneous report databases is used to monitor drug safety.  One of the major spontaneous report databases is the FDA Adverse Event Reporting System (FAERS).  Recently, the Japanese Adverse Drug Event Report database (JADER) was released.  To compare FAERS and JADER, we calculated the signals of adverse events by new quinolones (NQs).Methods: We extracted reports of adverse events by NQs from FAERS and JADER, and analyzed them using the ROR data mining algorithm.  Thirteen kinds of NQs were extracted, and the terms of adverse events extracted were defined by MedDRA.Results: There were 35,990,645 reports in FAERS and 1,643,404 reports in JADER.  Significant RORs were found for hypersensitivity (FAERS: 1.78, JADER: 1.47), arrhythmia (1.07, 0.68), hypoglycemia (1.80, 2.03), hyperglycemia (0.72, 0.78), rhabdomyolysis (1.01, 0.78), tendon disorders (15.18, 6.59), psychiatric symptoms (1.12, 0.45) and convulsion (0.99, 1.31).  We identified 4 types of adverse events by comparing FAERS and JADER: 1) Signal detection in both, 2) No signal detection in either, 3) Signal detection only in FAERS, 4) Signal detection only in JADER.Conclusion: Analyzing spontaneous report databases has several limitations, but is still a valuable tool for identifying potential associations between drugs and adverse events.  Spontaneous report databases may also be useful for detecting differences in adverse events between different races, countries and regions.