著者

大内 隆宏 平田 一耕 村山 和真 舟越 亮寛

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.24, no.4, pp.179-186, 2023-02-28 (Released:2023-04-07)

参考文献数

17

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Objective: The success rate of third-line treatment for Helicobacter pylori (H. pylori) infection has been reported to depend on the use of antibacterial agents, potassium-competitive acid blockers, and proton pump inhibitors. However, there is insufficient information on the success rate of H. pylori treatment due to the differences in the clinically used drugs. Here, the factors influencing the success rate of third-line treatment for H. pylori infection was investigated.Methods: Patients aged 20 years or older, who had received third-line treatment for H. pylori infection from January 2013 to December 2021 at the Kameda Medical Center were included. The exclusion criteria were as follows: patients with unknown treatment results and discontinuation of treatment. The primary endpoint was treatment success rate, based on the differences in the treatment regimen and drug choice, which was retroactively investigated from medical records. Confounding factors were adjusted by multivariate logistic regression analysis.Results: Treatment regimens containing sitafloxacin resulted in higher treatment success rates (p<0.05). Multivariate logistic regression analysis showed that the administration of sitafloxacin was the only statistically significant factor influencing treatment success. However, vonoprazan also tended to influence treatment success.Conclusion: Treatment with sitafloxacin and vonoprazan increases the success rate of third-line treatment against H. pylori infection.

著者

齋藤 百枝美 村上 勲 厚味 厳一 土屋 雅勇 夏苅 英昭

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.16, no.1, pp.1-9, 2014-05-30 (Released:2014-06-09)

参考文献数

6

被引用文献数

2

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Objective: In this study, we evaluated to examine the short-term educational effects for drug abuse prevention, including lectures and students’ awareness of drug abuse.Method: A questionnaire consisting of eleven items and SD method-based image survey were conducted three times, prior to and following the lectures and after the summer vacation for first-year students of the Department of Pharmacy.Results: The numbers of responses to the questionnaire surveys conducted prior to and following the summer vacation were 323 (response rate: 95.8%) and 332 (response rate: 97.9%), respectively.  When asked: “Do you think that people should be allowed to use cannabis (illegal herbal drugs) as long as they do not cause any trouble to others”, 2.8 (3.4) and 6.9 (6.6)% of students answered “Yes” after the lectures prior to the summer vacation and following it, respectively; there were both increased.  Following the summer vacation, 28.6% of students answered “Yes” to the question: “Have you ever seen or heard of people using cannabis or illegal herbal drugs ?”  A total of 2.1% of students had been “solicited to use cannabis or illegal herbal drugs”, and all of them stated that it would be “easy to obtain illegal herbal drugs”.  As the reason for drug abuse by young people, 140 students (42.2%) cited “curiosity”, and 81.6%, or 271 students, stated that they would “refuse” to use any illegal drugs even if they were asked to do so.  The results of the SD method-based image survey suggested significant changes in students’ awareness of drug abuse during the summer vacation; they had the image of little risk on drug abuse prevention following the vacation.Conclusion: The effects of learning were not maintained in some first-year students because they faced a variety of temptations during the short summer vacation and their normative consciousness and images of drug abuse easily changed.  Therefore, it is necessary to provide lectures for new students to help them acquire accurate knowledge of drug abuse, enhance their normative consciousness, and increase their self-awareness as health care professionals, develop curriculums on a continuing basis, and deploy specialists so that students with psychological problems as identified by the survey, including stress, escapism, mental weakness, and anxiety, can consult them.

著者

森次 幸男 和田 耕治 池田 俊也

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.23, no.4, pp.166-177, 2022-02-28 (Released:2022-05-27)

参考文献数

14

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Objective: The purpose of this study was to assess the opinions of healthcare professional regarding the contributions of the Medical Affairs department. Furthermore, we aimed to identify factors influencing and reasons for the contributions in the new coronavirus disease 2019 (COVID-19) pandemic situation.Design/Methods: A web-based survey was conducted among healthcare professionals (Key Opinion Leader/Key Thought Leader, KOL/KTL) who had multiple contacts with the Medical Affairs department, Japan.Results: The responses of 141 KOL/KTLs in Japan were collected; 77.3% of the respondents indicated that the contributions of the Medical Affairs department exceeded their expectations (achieved the expected level of contribution). The most common responses were “the identification of unmet medical needs” and “the dissemination of medical and scientific information, providing advanced medical and scientific information;” other responses included “promoting sales of the company's drugs.” The requests from KOL/KTLs regarding quality were “knowledge about biological and clinical statistics” and “proposal and quick response ability from the perspective of medical staff and patients,” but these responses were partially different between physicians and pharmacists. COVID-19 has resulted in substantial changes, for example, “face-to-face” interactions have significantly decreased from 91.5 to 50.4% and “Online” interactions have significantly increased from 20.6 to 70.9%. However, the effects of the declaration of emergency state could not be identified. The KOL/KTLs requested to make the meeting times more appropriate, conduct in-depth two-way discussions, provide latest information, and discuss about professional manners and behaviors.Conclusion: In summary, regardless of the changes in the types of activities caused by COVID-19, the Medical Affairs department has made substantial contributions to healthcare professionals, who highly appreciated them. Furthermore, depending on responses of individuals whose expectations could not be met, areas of improvements have been suggested.

著者

明貝 怜美 澤井 夏海 須藤 洋行 佐藤 宏樹 藤田 行代志 三島 八重子 木﨑 速人 堀 里子 澤田 康文

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.24, no.1, pp.11-16, 2022-05-31 (Released:2022-06-11)

参考文献数

7

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Objective: Pharmacists at insurance pharmacies play an important role in the pharmaceutical care of outpatients receiving cancer chemotherapy. This study aimed to clarify the actual status of insurance pharmacies' involvement in cancer chemotherapy and associated issues, based on an analysis of prescription inquiries made to doctors by pharmacists at an insurance pharmacy.Design: This was a retrospective observational study.Methods: The data was collected in one insurance pharmacy, which received prescriptions mainly from Gunma Prefectural Cancer Center. Among 2, 258 inquiries recorded from January 2015 to May 2018, inquires related to oral anticancer drugs or supportive care medicine were extracted. The frequency of inquiries for each item, or the frequencies of factors that lead to inquiries were calculated. Inquiries considered to have potentially led to the prevention or avoidance of adverse drug reactions (ADRs), so-called “preavoidance” inquiries, were also extracted.Results: Four hundred and forty inquiries related to 20 oral anticancer drugs were included in the analysis. The prescriptions were changed after 92.7% of all prescription inquiries. Prescription inquiries for drugs with rest periods were more frequent than those for drugs without rest periods. The most common inquiries were about the medication schedules stated on the prescription, followed by inquiries about supportive care drugs. Approximately 60% of the pharmacy inquiries were related to“pre-avoidance”inquiries. Most of the pre-avoidance inquiries concerned prevention of ADRs, though these inquiries also contributed to“reduction or avoidance of mental anxiety”. The prescription inquiries were triggered by information collected by pharmacists from patient interviews and from medication histories.Conclusion: Our findings suggest that inquiries to the prescribing doctors by pharmacists at insurance pharmacies contribute significantly to the appropriate use of anticancer drugs.

著者

森次 幸男 水野 裕久 柴 英幸 今野 浩一 岩崎 幸司

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.22, no.2, pp.59-82, 2020-08-31 (Released:2020-09-18)

参考文献数

9

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Objective: The purpose of this survey was to identify the roles, organizational structure, responsibilities, recruitment, skills, performance indicators and future trends of Medical Science Liaisons (MSLs). In addition, we compared the trend of changes with past surveys.Method: We contacted 52 pharmaceutical companies with a questionnaire survey on MSLs which included 28 items and analyzed the anonymized results using a web response system in Japan.Results: Responses were received from 40 companies (76.9%). The range of MSLs in each company was 0 to 80, the average number for companies withone or more MSLs was 23.6 (median was 13.0). Except for one company, the definition of “MSL” was generally the same. Except for one company, MSLs operated independently of the sales promotion activities. One MSL was responsible for an average of 21 Key Opinion Leader/Key Thought Leaders (KOL/KTL). The key performance indicators (KPI) for MSL activities mainly focused on quantitative indicators such as the number of information collections from KOL/KTL. On the other hand, qualitative indicators were also incorporated suchas feedback from KOL/KTL. “Knowledge of clinical medicine” and “Communication skills” were necessary skills for all companies. 41.9% of companies had an in-house certification program. Some companies will retain and/or decrease the number of MSLs in the future. MSLs were required to have advanced medical expertise as well as medical professional qualifications, and it was confirmed that there are various options for career plans such as MA, R&D, and promotional departments. No matter what the MSL’s therapeutic area (TA), many companies had high expectations for their activities.Conclusion: The current status of expected mission and responsiblities, KPI, size and career plans for MSL were revealed. Companies want MSL’s to play a central role in the inplementation of medical strategies and contribute to internal and external stakeholders.

著者

穴見 江梨子 坂本 豊伸 磯尾 優子 德山 智治 塚本 賢児 興津 暁子 天方 奉子 稲葉 一郎 宮野 恭彰 木戸 宏幸 湯川 栄二

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.23, no.3, pp.135-142, 2021-11-30 (Released:2021-12-14)

参考文献数

14

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Objective: Soon after two massive earthquakes in Kumamoto, Japan, on April 14 and 16, 2016, the Shirakawasuigen pharmacy located in the Minamiaso village received prescriptions for disaster medications. Since prescriptions for disaster medications are typically used at temporary emergency shelters, pharmacies usually do not receive requests for them. On checking the content of these prescriptions, we found numerous prescription errors and queries. This study aimed to assess issues with dispensing medications after disasters.Methods: We reviewed all disaster medication prescriptions received by the pharmacy from April 20 to May 28, 2016 and the medication histories of these patients. We confirmed each patient’s data and medical and medication histories. Furthermore, we classified disaster prescription errors and queries into five categories according to their content and summed them in each category.Results: We obtained patients’ medical and medication histories from 100 (77.5%) of the 129 prescriptions received. Of the 129 prescriptions, a total of 158 prescription errors and queries pertaining to 96 (74.4%) prescriptions were confirmed: 88 (55.7%) for unclear medication usage and dosages, 22 (13.9%) for incorrect medication names, 34 (21.5%) for pharmaceutical queries, 8 (5.1%) for exceeding fixed prescription days (within seven days), and 6 (3.8%) for other issues.Conclusion: Nearly 80% of the prescriptions for disaster medications had prescription errors and queries. Therefore, we evaluated that the prescription’s format and entry method can be improved. Furthermore, to ensure a smooth drug supply and to reduce prescription entry deficiencies and formal prescription queries, pharmacists need to effectively manage disaster prescriptions.

著者

豕瀬 諒 髙谷 瑞穂 村木 優一

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.22, no.3, pp.135-140, 2020-11-30 (Released:2020-12-15)

参考文献数

13

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Objective: In Japan, healthcare professionals are required to report the adverse drug events that occur with the use of medicines to the Minister of Health, Labor, and Welfare. The reported information is collected in the Japanese Adverse Drug Event Report database (JADER) and is freely available. There are no reports that evaluated the adverse events (AEs) in JADER based on the need for a physician’s diagnosis. This study classified AEs by pharmacists or physicians in JADER based on the need for a physician’s diagnosis and evaluated the differences in their contents.Methods: AEs reported by pharmacists, physicians, pharmacists and physicians in the economic years 2004 to 2017 in JADER were collected annually, and the trends were compared. The AEs of methotrexate in 2017 were classified into two groups based on the need for a physician’s diagnosis. The necessity of a physician’s diagnosis was judged by two senior pharmacists and compared using the chi-squared test.Results: The number of AEs reported by pharmacists and physicians from 2004 to 2017 increased from 689 to 7,127 and from 20,933 to 39,382, respectively. Among the AEs of methotrexate in 2017, AEs requiring physician’s diagnosis reported by pharmacists were 337 events and physicians were 2,413 events. Whereas, AEs that did not require a physician’s diagnosis reported by pharmacists were 172 events and physicians were 321 events. Physicians had significantly more AEs requiring diagnosis than pharmacists did (p< 0.0001).Conclusion: The reports of pharmacists with JADER have fewer AEs with the diagnosis than those of physicians.

著者

勅使河原 彩織 茂木 義輝 阿部 真也 松井 洸 山口 浩 吉町 昌子 野村 和彦 富澤 明子 成井 浩二

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.23, no.2, pp.61-71, 2021-08-31 (Released:2021-09-25)

参考文献数

6

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Objective: There have been reports of health hazards caused by medical devices, cosmetics, quasi-drugs, daily necessities, hygiene products, etc. (health-related products) sold in pharmacies and drugstores. However, the role pharmacists play in dealing with the health hazards caused by health-related products has not been clarified. Therefore, we conducted a survey on the cases of health hazards related to health-related products and the views of pharmacists.Methods: A questionnaire was administered anonymously by email to 601 pharmacists working in community pharmacies or drugstores between December 11 and 20, 2019.Results: The number of valid responses was 585. The breakdown of health hazard cases where pharmacists counseled customers were 60 for medical devices, 31 for cosmetics, 18 for quasi-drugs, 9 for hygiene products, and 20 for daily necessities and others. Of those 138 cases, 19 cases of medical devices were estimated to have an intermediate risk as a health hazard, and the other 119 cases were all classified as low. Of the cases that the pharmacists were not approached for help, but were aware of, 57 were medical devices (21 high, 31 intermediate, 5 low), 44 were cosmetics (12 intermediate, 32 low), 12 were quasi-drugs (7 intermediate, 5 low), 7 were hygiene products (7 low), and 64 were daily necessities and others (26 high, 34 intermediate, 4 low). With regard to health-related products, 95% of the respondents indicated that they had responded to customer questions with advice.Conclusion: Our results show that there are various cases that could develop into health hazards due to health-related products, and most respondents felt a need to alert the public. As such, pharmacists and other staffs in drugstores will continue to provide health support functions to their customers by advising them on not only pharmaceuticals but also these health-related products.

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

村上 雅裕 三浦 友里 桂木 聡子 大野 雅子 天野 学 森山 雅弘

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.17, no.3, pp.140-144, 2015 (Released:2015-12-18)

参考文献数

5

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Objective: For pharmacists to select a suitable auxiliary device for eye drop administration for patients who have difficulty in applying eye drops, the pharmacists need to know the characteristics and level of difficulty of using each device.Methods: Thus, we compared the characteristics of New Rakuraku Tengan, Rakuraku Tengan III, and an eye-drop self-help device and also conducted a survey involving 40 healthy volunteers on each device’s accessibility and suitability for people with motor disabilities.Results: New Rakuraku Tengan received the highest score for “usage was able to easily understand” (70.0% of the respondents answered positively) and “suitability for poor-sighted people” (65.0%).  Rakuraku Tengan III received the highest score for the “effectiveness of photos and illustrations in the manual” (77.5%), but was evaluated to be difficult to use.  The eye-drop self-help device received the highest score for “suitability for people with difficulty raising their shoulders and arms” (75.0%).Results: Thus, we observed the need for pharmacists to have thorough knowledge of the products in order to recommend suitable auxiliary devices for eye drop administration for each patient.

著者

阿部 真也 松本 忍 小林 彦登 斎藤 太寿 宮下 博幸 高野 照子 堺 直子 柴田 壮一 厚田 幸一郎

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.14, no.2, pp.75-81, 2012 (Released:2012-09-04)

参考文献数

10

被引用文献数

2

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Objective: In the intensive care unit (ICU), drugs are administered in sequence as the conditions of the patient change rapidly, and there are often cases where many injections are administered simultaneously.  For this reason, it is important to quickly select the appropriate administration route.  In this study, we prepared a quick reference table for incompatibilities of frequently used and highly important injections in the ICU (referred to as the “quick reference table”) that will enable selection of the appropriate administration route, and we investigated the status of use and usefulness of this quick reference table.Methods: The drugs included in the quick reference table were extracted from prescription records from May to October 2009, and these were finalized by discussions with the nurses in the ICU.  Three reference materials were used: Manual on the Supervision of Injection Preparation (3rd Edition), Data Search on Injection Incompatibilities 2009, and MICROMEDEX®.  The survey was conducted with all 12 nurses in the ICU after 4 months of distributing the quick reference table.Results: The quick reference table included 57 pharmaceutical items, and compatibility was classified into 10 categories.  The quick reference table was prepared as one A3 page for convenience.  The retrieval rate of the survey was 100%.  The average number of years of practical experience as a nurse was 12.2 years, and 11 out of 12 nurses used the quick reference table.  Of the 11 nurses who used the table, 6 answered that it was “very useful,” while 4 answered that it was “useful.”  All 11 nurses who used the quick reference table answered that they “consulted the pharmacists less frequently.”Conclusion: Satisfactory evaluations were obtained with regard to the details included in the quick reference table, and the table was estimated to be highly useful and important even for ICU nurses with many years of experience.  Furthermore, it was suggested that the quick reference table was also useful in reducing the workloads of the pharmacists.

著者

波多江 崇 田中 智啓 猪野 彩 田内 義彦 竹下 治範 辰見 明俊 濵口 常男

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.18, no.4, pp.289-294, 2017-02-28 (Released:2017-03-17)

参考文献数

24

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Objective: We conducted a meta-analysis on the suppressive effect of resistant maltodextrin on post-prandial blood glucose elevation, which is approved in Japan as food for specified health use, and the following is allowed to be indicated on the label “it is suitable for consumption by those who are concerned about their post-prandial blood glucose levels because the absorption of sugars is abated by the action of dietary fiber (resistant maltodextrin).”Method: Our literature search covered Ichushi-Web (Japan Medical Abstracts Society), Japan Science and Technology Information Aggregator, Electronic (J-stage), Google Scholar, and PubMed databases and extracted English and Japanese publications on randomized, double-blind, controlled studies comparing resistant maltodextrin and a control in Japanese subjects for the reduction of areas under the blood glucose response curves at 30, 60, and 120 min after eating as an efficacy index.Result: Among these publications, four articles with a Jadad score (an assessment of the quality of randomized controlled studies) of ≥ 3 were included in the meta-analysis.  Significant inhibitory effects were confirmed from areas under the blood glucose response curves at 30, 60, and 120 min after eating in the meta-analysis that was performed to evaluate the effects of resistant maltodextrin on post-prandial blood glucose elevation in Japanese individuals.Conclusion: However, we were not able to test for publication bias because the number of extracted publications was small, and thus, additional research and case studies are warranted.

著者

稲葉 一郎 大浦 華代子 中田 雄一郎 今井 輝子

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.21, no.1, pp.1-8, 2019-05-31 (Released:2019-06-21)

参考文献数

11

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Objective: The use of generic products is a solution to the increasing healthcare cost in Japan. The pharmaceutical companies are trying to develop several generic products suitable to patient’s taste. The contribution of pharmacist by selecting generic product to each patient and a collection of patient’s opinion for products may accelerate the development of generic products improved usability for patients and medical workers. The present study examined the storage of generic products of sennoside in pharmacies and the patient preference for selection of generic products in 2003 and 2016 in Kumamoto, Japan.Methods: Sennoside was selected as a model drug, since it developed several generic products for long period. The survey on storage of sennoside pharmaceutics and the questionnaire survey for its generic products to patients were conducted at ethical pharmacies. The appearance and the dissolution of sennoside from generic tablets were compared with original product, Pursennid.Results: Thirteen sennoside products were stored in 2003 and 2016. The number of pharmacies that stored generic products increased from 33 to 54% in 13 years. The largest number of patients preferred Pursennid in 2003. In contrast, two generic products were more preferred than Pursennid in 2016. Interestingly, the reasons for preferring products were almost the same between 2003 and 2016, and their majority was color and size of tablet. The generic products tend to have a thinner thickness and larger diameter than Pursennid. The most preferred generic product in 2016 showed a faster dissolution of sennoside than Pursennid. However, the use of generic products is mainly related to their tablet appearances due to unrelation between the pharmacological effect of sennoside and its dissolution in GI tract.Conclusion: In the development of generic products of sennoside, as well as quality, the appearance is an important factor.

著者

山本 緑 石井 祐次

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.20, no.1, pp.41-46, 2018 (Released:2018-06-16)

参考文献数

21

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Objective: Smart drugs are widely used for nonmedical reasons in Western countries.  Given that smart drugs are often used for years, long-term effectiveness and safety are essential, but particularly difficult and costly to determine.  The use of smart drugs seems to be common among individuals in cognitively demanding environments, such as schools and universities, although the actual consumption of smart drugs has not been elucidated in Japan.  To monitor the prevalence of smart drugs among undergraduates, we conducted an awareness survey in Kyushu University and Healthcare Management College.Results: We found that 98% of students had never used smart drugs.  When asked “Would you like to use smart drugs ?” 55% of the students answered “No,” 10% answered “Yes,” and 33% answered “I couldn’t say.”  No associations were observed between these answers and sex, drinking, smoking, and pressure on academic performance.  It is suggested that users of soft enhancers, such as caffeine-containing products for cognitive enhancement, are more likely to use smart drugs.  We found that half of the students had used energy drinks for neuroenhancement prior to an exam.Conclusion: The present study indicated a low prevalence of smart drug use compared with that in other countries, whereas the use of caffeine-containing products for cognitive enhancement appeared to be similar to Western usage.  Furthermore, approximately 30% of the students agreed with the use and effectiveness of smart drugs.  Further studies of smart drugs among students should be conducted to prevent the abuse.

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.

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

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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

野口 義紘 林 勇汰 吉田 阿希 杉田 郁人 江崎 宏樹 齊藤 康介 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.18, no.4, pp.277-283, 2017-02-28 (Released:2017-03-17)

参考文献数

20

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Objective: Elderly patients commonly experience adverse drug events (ADEs) owing to their poor drug metabolizing and excretion ability, and these often cause multiple organ dysfunction syndrome.  Therefore, it is important that we identify the adverse drug events early on during prognosis.  We searched for oral medicines that might exacerbate the prognosis of ADEs in elderly patients.Methods: The objects under analysis were oral medicines that were registered in the Japanese Adverse Drug Event Report database (JADER).  The associations between the elderly/non-elderly patients and exacerbation risk/non-exacerbation risk were analyzed by risk ratios (RR).  The signal detection of exacerbation risk was defined as 95% confidence interval of lower limit of risk ratio>1 and χ2≥4.Results: The oral medicines that might markedly exacerbate the prognosis of ADEs in the elderly patients in comparison with the ADEs of young patients included 84 items, of which 63 have not been described as potentially inappropriate medicines in all guidelines for medical treatment of the elderly patients.Conclusion: In this study, while we could not search for oral medicines having a high risk of ADEs, we were able to search for oral medicines that might exacerbate the prognosis of ADEs in elderly patients.  This result could contribute to the proper use of medicines in the elderly patients.

著者

森 千与 酒井 隆全 矢野 玲子 田辺 公一 後藤 伸之 大津 史子

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.18, no.4, pp.261-269, 2017-02-28 (Released:2017-03-17)

参考文献数

24

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Purpose: The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events.  We performed a case series study.Methods: We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University.  We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.Result: We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events.  The most frequent offending drug in both groups was ritodrine hydrochloride.  The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride.  The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.Discussion: We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride.  Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride.  We need to monitor both mothers and fetuses during the drug administration.  It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers.  Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy.  We believe the results could be helpful in the early detection of adverse events in the future.

著者

Masayuki Ikenishi Akiko Kuroda Haruhiko Tsukazaki Masahiko Nakao Masashi Takeuchi Yuji Konishi Toshiyuki Matsuda Tohru Ohtori Kenji Matsuyama Mitsutaka Takada Hiroki Satoh Yasufumi Sawada Mutsuaki Ueda

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.3, pp.172-178, 2016 (Released:2017-02-14)

参考文献数

32

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Objective: To compare effects of the fluoropyrimidines S-1 and capecitabine on prothrombin time international normalized ratios (PT-INR) of warfarin following coadministration and after discontinuation of each fluoropyrimidine treatment.Methods: Medical records of patients receiving warfarin with either S-1 (6 patients) or capecitabine (7 patients) were obtained from four hospitals.Results: Increased PT-INR was observed until peak levels of warfarin were achieved in all patients in S-1 and capecitabine treatment groups. Moreover, PT-INR significantly changed after coadministration within each group (p<0.05). Specifically, ratios of peak PT-INR after coadministration of each fluoropyrimidine and those following administration of warfarin alone (PT-INR elevation ratio) were 3.31 and 3.29 in S-1 and capecitabine coadministration groups, respectively. Moreover, numbers of days to peak PT-INR were 38.3 and 31.3 days, respectively, and did not significantly differ between the treatment groups. Furthermore, PT-INR returned to pretreatment levels by 17.5 and 15.1 days after discontinuation of S-1 and capecitabine, respectively, and did not significantly differ between the treatment groups.Conclusion: Coadministration of S-1 and capecitabine similarly prolongs PT-INR by approximately 3-fold compared with administration of warfarin alone; therefore, these drug-drug interactions were clinically suggested to be of high risk for episodes of bleeding and remarkable alterations in coagulation parameters. Therefore, blood coagulation ability should be more carefully monitored with regard to PT-INRs in patients receiving warfarin with S-1 or capecitabine not only during coadministration but also after discontinuation of fluoropyrimidine treatments.

著者

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

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.106-113, 2016 (Released:2016-09-27)

参考文献数

21

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Objective: Medical education was initiated in 2012 as part of health and physical education (HPE) in junior high schools.  This new measure was a result of a revision of school curriculum guidelines.  In this study, we aimed to clarify the implementation status of medical education in schools.Methods: A questionnaire survey targeting junior high school teachers in Gifu (from 184 junior high schools) was conducted by mail.Results: 60.9% of schools responded (112/184).  HPE teachers and school pharmacists were found to be in charge of providing medical education in 94.6% and 10.7% of schools, respectively.  The average duration of classes was 50 min and the average frequency was 1.2 times a week.  On average, 0.9% of schools stated that implementing medical education was “under contemplation,” 2.7% held “occasional” classes, and 2.7% only held “drug abuse-related” classes.  It was also found that the most commonly used educational material was the school textbook (91.1% of schools).  Additionally, 87.5% of schools responded “yes” to “lectures are delivered by outside lecturers,” and 69.6% responded “yes” to “we hope to introduce workshop participation.”Conclusion: The results of the survey indicated that many junior high schools have provided medical education classes and that HPE teachers were in charge of teaching these classes.  However, some schools have not provided these classes.  It is considered necessary to enhance medical education activities in the pharmaceutical field by involving specialists from different areas.