著者

小池 麻由 大津 史子 榊原 仁作 後藤 伸之

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.4, pp.134-143, 2013-02-28 (Released:2013-03-06)

参考文献数

20

被引用文献数

12

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Objective: Recently, use of health foods and supplements, as well as the amount of information available about them, has been steadily increasing.  Therefore, a noticeable increase in adverse drug reactions caused by health foods and supplements has also been seen.  The purpose of this study was to clarify the current status and backgrounds of patients with health food- or supplement-related adverse health effects.Methods: We selected the cases of health food- or supplement-related adverse health effects from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database, which contains over 57,000 case reports of adverse drug reactions.  We investigated the background, suspected products and adverse events in each case and conducted univariate logistic regression analysis to determine significance.Results: We obtained a total of 327 cases consisting of 103 causative products.  Women comprised 66% of study subjects and had a significant association with dietary supplements.  Patients with a history of liver disease had a significant association with liver damage caused by “Ukon,” a drink made from turmeric root and sold as an anti-hangover remedy in Japan.Conclusion: The causative products had several unique features.  This information should be utilized to prevent health food- and supplement-related adverse health effects in the future.

著者

竹下 治範 井上 知美 髙瀬 尚武 波多江 崇 室井 延之 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.270-276, 2017-02-28 (Released:2017-03-17)

参考文献数

10

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Objective: Finger-tip unit (FTU) has been used in Western countries to apply a specific amount of steroid ointment available in tube form.  Although prescription ointments for treating skin disorders are available in Japan, there are no indications for patients regarding the amount to be used.  Therefore, we investigated the factual assessment of patient compliance instructions on using the ointments given by pharmacists and conducted a comparative test on the amount of ointment in 1 FTU using commercially available ointment tube products.Methods: We conducted a questionnaire survey for 21 hospital pharmacists on patient compliance instructions for ointments.  Using six types of ointments, we measured the aperture area of ointment tube, weight of 1 FTU and squeezing number of tube.Results: Fewer than 50% of pharmacists explained the application methods and amounts for one-time use when they provided patient compliance instructions.  There were many patients who used an ointment inadequately.  The most were problems about the quantity of application.  Wide variations were found among the amount of ointment in 1 FTU weight and number of available uses.Conclusion: The survey results demonstrated that the methods used to apply the ointments are items that must also be emphasized by pharmacists when providing patients compliance instructions.  Furthermore, the patient compliance instructions should include the amount of ointment in 1 FTU and number of available uses within pharmaceutical products.

著者

高橋 斉 玉木 啓文 佐藤 宏樹 澤田 康文

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.19, no.2, pp.43-49, 2017 (Released:2017-09-07)

参考文献数

6

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Objective: Generic drugs similar in appearance to their brand-name counterparts have both advantages and disadvantages.  This study aimed to investigate patient preferences regarding the appearance of generic drugs.Design: A cross-sectional survey.Methods: We conducted a web-based survey between 2013 and 2014.  Patients aged ≥40 years who reported taking prescription drugs for >6 months were asked to provide their opinions on the appearance of generic drug formulations and press-through packages (PTPs).  Medical doctors and pharmacists were asked as to what type of appearance of generic drugs would be suitable as well as whether the appearance of these drugs and PTPs should be similar to that of their brand-name counterparts.Results: A total of 911 patients, 238 pharmacists, and 81 medical doctors responded to the survey.  Most of the patients (45.3%) surveyed reported that the similarity in the appearance of generic drug formulations and PTPs to those of their brand-name counterparts was not important, whereas only 15.6% of patients preferred generic drug formulations and PTPs similar in appearance to their brand-name counterparts.  In contrast, most of the medical doctors (53.1%) and pharmacists (88.2%) reported that the appearance of generic drug formulations and PTPs should be similar to that of their brand-name counterparts.Conclusion: Patients’ opinions on the appearance of generic drugs differ from what medical doctors and pharmacists perceive them to be.  Therefore, health care professionals should select generic drugs with an appearance as per the individual patient’s preference.

著者

中川 直人 村井 ユリ子 小原 拓 大原 宏司 栗田 幸代 Lai Leanne

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.19, no.4, pp.180-187, 2018 (Released:2018-03-21)

参考文献数

9

被引用文献数

1

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Objective: The clinical literature review is an important and required components in most of the US pharmacy school curriculum.  On the other hand, in Japan, pharmacy students usually read basic literature when research assignments are given.  However, in Japan, one is rarely taught how to critically read clinical literature in class.  Therefore, for the purpose of examining whether or not lectures regarding how to critically read clinical literature will affect collecting new drug information in pharmacy practice, we examined a survey which we circulated in both countries.  The survey asks pharmacists about reading clinical literature.Methods: One thousand nine hundred and ninety-seven pharmacists in Miyagi in Japan were given questionnaires by mail and 18,744 pharmacists in Florida in the US were given the URL of a web questionnaire by email.Results: Response rates in Miyagi and Florida were 30.3% and 0.91%, respectively.  Since the response in Florida was so small, statistical analysis was not performed.  Regarding the question of “Do you HABITUALLY read clinical literature ?,” “Yes” in Miyagi and Florida was 14.7% and 71.9%, respectively.  Regarding the question of “To what extent did you learn how to critically read clinical literature when you were a student-pharmacist ? ” (1: Not at all, 7: Yes), medians in Miyagi and Florida were “1” and “5,” respectively.  Regarding the question of “To what extent do you apply the information you obtain from clinical literature to your daily responsibilities ? ” (1: Not at all, 7: Yes), medians in Miyagi and Florida were “2” and “5,” respectively.Conclusions: We conclude that Japanese pharmacists in clinical practice do not sufficiently utilize drug information from new clinical literature because pharmacy education in Japan did not, until very recently at least, teach how to critically read clinical literature in class.

著者

佐藤 弘康 晴山 知拓 大井 菜美子 谷口 雄人 石田 陽美 八幡 弘子 橋本 義宏 小森 均

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.2, pp.63-69, 2014 (Released:2014-09-06)

参考文献数

12

被引用文献数

2

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Objective: Taking the wrong medicine or medication error is a serious concern to patient safety.  The aim of this study was to statistically survey the relation between the placement of drugs on medicine shelf and the occurrence of error in taking a medicine.Methods: The study comprised 2 groups.  The incident group contained 43 cases that were erroneously taken in the Obihiro Kosei General Hospital.  The control group contained 43 drug pairs matched by the similarity index of the drug names from among the drugs used in the hospital at random.  The similarity index of drug names was based on 10 quantitative indicators.  The distance of medicine shelf arrangement was represented by three variables: the horizontal distance, the vertical distance and the distance of shelf block.  Conditional logistic regression analyses of the occurrence of medication errors were performed by evaluating the three variables of the distance factor and their interaction for error in taking a similar-sounding named drugs.Results: Conditional logistic regression analysis revealed that the vertical distance (OR: 0.64, 95%CI: 0.42-0.99) and the distance of the shelf block (OR: 0.74, 95%CI: 0.57-0.97) were significant risk-reduction factors of medication errors.  Four variables were extracted as the most suitable logistic regression model in terms of the interaction between them.  As the interaction between 3 variables (the horizontal distance, the vertical distance and the distance of shelf block) was significant (OR: 0.93, 95%CI: 0.86-0.99), they may be considered as synergistic risk-reduction factors.  Moreover, the horizontal distance was found to be a risk-enhancement factor (OR: 1.52, 95%CI: 0.93-2.48).Discussion: In order to reduce the risk of medication errors due to similar-sounding drug names, placement of drug on the medicine shelf should take into consideration the three coordinates of the distance factor.

著者

横井 正之 田城 孝雄

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.19, no.4, pp.188-194, 2018-02-28 (Released:2018-03-21)

参考文献数

10

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Objective: We analyzed the effects of the number of prescriptions on the number of drug stocks in community pharmacies by administering questionnaires to community pharmacies in Shiga Prefecture, Japan (N=159).Methords: We identified a significant positive correlation between drug stocks and their amount, and a significant negative correlation between inventory turnover and the concentration ratio of prescriptions issued by any medical institutions.  Therefore, this implies that the amount of drug stocks influenced value, and a lower ratio of prescriptions issued by neighboring medical institutions increased inventory turnover.  Furthermore, multi-regression analyses on the amount of drug stocks and the number of prescriptions from neighboring medical institutions and other medical institutions were performed.  The results are as follows.Results: The number of stock drugs is much less influenced by the number of the prescription of vicinity medical institutions than the other medical institutions.  On the other hands, the money amount of stock is more influenced by the number of the prescription of vicinity medical institutions than the other medical institutions.Conclusions: We thus identified the relation between the number of prescriptions from neighboring or other medical institutions and the number of drug stocks and their amount.  These findings will be made available to community pharmacies that want to prescriptions issued by not only the neighboring medical institutions but others as well.

著者

恩田 光子 今井 博久 春日 美香 安田 実央 下村 真美子 岡本 夏実 高田 百合菜 七海 陽子 田中 有香 荒川 行生

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.1, pp.21-33, 2015 (Released:2015-06-28)

参考文献数

37

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Objective: To examine the effect of pharmacists’ visits to homebound patients on the elimination of unused drugs.Method: We conducted a survey with pharmacies throughout Japan that provided home-visit service, asking them questions regarding their work with up to five patients (the survey period was from January 15 through the end of February, 2013).  Main survey questions were: (1) whether they managed unused drugs since the start of their home-visit, and (2) how they managed the unused drugs.  For (2), we conducted case studies by asking the pharmacists to choose the case that impressed them most and describe the unused drugs involved, actions taken, and the results.Results: Data on 5,447 patients were collected from 1,890 pharmacies throughout Japan (collection rate: 56.9%).  Pharmacists managed unused drugs from 2,484 patients (45.6%). 1,746 patients (3,590 cases) were qualified for analysis.  In 2,332 cases (65.0%), pharmacist intervention eliminated the incidences of unused drugs.  In 782 cases (21.8%), unused drugs were discarded, while the number of drug administration days was adjusted in 2,623 cases (73.1%).  In 21 cases (0.6%), drugs were both discarded and had the number of days adjusted.  There were others for 164 cases (4.5%).  The total price of the eliminated unused drugs was approximately 6,920,000 yen (4,000 yen/person).  Illnesses that benefited most from the elimination of unused drugs were chronic respiratory failure (16,306 yen/person), and Parkinson’s disease (4,803 yen/person).Conclusion: We confirmed the economic effect of eliminating unused drugs by pharmacists’ home visits.

著者

峯垣 哲也 湯月 翔太 伯井 理恵子 藤井 尚子 濱田 美輝 若林 未稀 辻本 雅之 西口 工司

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.19, no.3, pp.97-103, 2017 (Released:2017-12-27)

参考文献数

8

被引用文献数

1

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Objective: A simple suspension method in our previous study indicated that the amount of amlodipine recovered from a Norvasc®OD tablet was decreased by simultaneous suspension of a Magmitt®tablet containing magnesium oxide, due to the increase in pH.  However, it is still unclear whether this incompatibility arises in both brand name and generic tablets because the tablets may have different additives and mechanical properties.  In this study, we evaluated the degree of incompatibility between Magmitt®tablets and a range of amlodipine besylate tablets, including original and generic versions.Methods: Twenty-four kinds of amlodipine besylate tablets were used.  Magmitt®and amlodipine besylate tablets were suspended in warm water (55°C), and 10 min or 2 h later, the amount of amlodipine in the suspension was measured by HPLC-UV.Results: For almost all tested tablets, the recovery amount of amlodipine was significantly decreased in the presence of Magmitt®, and the amount recovered varied significantly between the types of amlodipine tablets.  However, Magmitt®tablet had little effect on the recovery of amlodipine from two specific brand tablets.Conclusions: An incompatibility between Magmitt®and most types of amlodipine besylate could be observed, although the degree of incompatibility depended on the brand of amlodipine.  These results are useful for the proper use of drugs.

著者

舘 知也 野口 義紘 寺町 ひとみ

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.1-11, 2018 (Released:2018-06-16)

参考文献数

68

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Objective: A medication notebook is developed in order to unitedly manage medication information of patients and is used by writing medication information such as history of ethical drugs, over-the-counter drugs and health foods, anamnesis, history of adverse events and allergy.  Adverse events, interaction and duplication of drugs can be prevented by showing a medication notebook to doctors and pharmacists.Data Sources·Study Selection·Data Extraction: In this article, we reviewed literatures regarding preceding studies on the utilization of medication notebooks comprehensively.Results·Conclusion: In our review, we could comprehend literature on medication notebooks systematically and could summarize a lot of evidences that confirm the usefulness of medication notebooks.  We need to produce further evidences on medication notebooks to spread medication notebooks.

著者

竹馬 章悟 小川 竜一 越前 宏俊

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.4, pp.175-184, 2016 (Released:2016-03-19)

参考文献数

72

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Objective: To evaluate the validity of dosage adjustment of renally eliminated drugs using Giusti and Hayton method in patients with renal dysfunction by reviewing the pharmacokinetic data of the drugs.Design: A systematic literature review.Methods: Drugs with the following characteristics: ≥70% of the drug excreted in urine is the unchanged form and ≥20% of the drug in plasma is the unbound drug, were retrieved from Goodman and Gilman’s the Pharmacological Basis of Therapeutics, 12th edition.  For the drugs identified, the area under the concentration-time curves (AUC) obtained from pharmacokinetic studies in healthy subjects and patients with renal dysfunction were extracted from package inserts, interview forms, summary basis of approval, and by systematic review of the MEDLINE database.  Pharmacokinetic studies in children, patients with end-stage renal disease, patients on hemodialysis, and kidney transplanted patients were excluded from this review.  The observed AUC ratio (AUCRobserved) of a drug was calculated by dividing mean AUC of patients by that of healthy subjects, and stratified by creatinine clearance (CLcr) into three categories: 50 to 79 mL/min, 30 to 49 mL/min, and 10 to 29 mL/min.  Theoretical AUC ratios (AUCRpredicted) of drugs for the respective CLcr categories were calculated using Giusti and Hayton method.Results: Twenty-six drugs met our study criteria, and 43 data sets were obtained from the data sources.  The AUCRobserved deviated from the AUCRpredicted by more than ±50% in 3 of 35 (9%) data sets for CLcr 50 to 79 mL/min, 4 of 39 (10%) data sets for CLcr 30 to 49 mL/min, and 7 of 29 (24%) data sets for CLcr 10 to 29 mL/min.Conclusion: Since AUCRpredicted calculated by Giusti and Hayton method erratically over- or under-estimates the maintenance doses in patients with reduced renal function, the use of AUCRobserved is preferred for dose adjustment in these patients.

著者

今井 志乃ぶ

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.2, pp.N29-N32, 2014 (Released:2014-09-06)

参考文献数

3

著者

Takuro Okada Masahito Nakazaki Asami Funaki Mariko Kawana Masateru Ito Hirokazu Ishizuka Junko Nagai Atsushi Tanaka Ryokan Funakoshi Tadanori Sasaki

出版者

Japanese Society of Drug Informatics

雑誌

Iyakuhin Johogaku (ISSN:13451464)

巻号頁・発行日

vol.19, no.3, pp.104-110, 2017 (Released:2017-12-27)

参考文献数

11

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Objective: Although generic drugs are considered bioequivalent to the original drugs, for formulations such as adhesive agents, the sensation during use (hereinafter, “sensation”) and handling characteristics (hereinafter, “handling”) are usually not investigated during the approval process.  Therefore, we established new drug evaluation criteria for transdermal adhesive agents, which included those relevant to handling and sensation, and investigated their usefulness.Methods: This study assessed four test samples: the original loxoprofen sodium 100 mg tape (hereinafter, “LX-P 100 mg”) and three generic versions considered economically acceptable by our hospital.  The formulations were evaluated based on our criteria for generic drugs.  The handling and sensation were evaluated using a questionnaire with six parameters related to sensation and seven parameters related to handling.  The enrolled subjects comprised 20 pharmacists from our hospital.  Furthermore, a parallel evaluation using loxoprofen sodium 50 mg tape (hereinafter, “LX-P 50 mg”) was performed to explore the variance in the results of each individual criterion.Results: The evaluation revealed differences between the formulations with regard to the thickness of the adhesive agent and stability after opening the package.  Various differences were observed by evaluation of the handling and sensation.  Based on the parameters used, the differences between the various formulations of LX-P 100 mg occurred in the following criteria: tactile sensation commensurate to the degree of adhesion; superficial resemblance to other agents; ease of adhesion; and ease of package opening.  For LX-P 50 mg, the differences were found in superficial resemblance to other agents and ease of liner removal.Conclusion: Our newly established criteria for the evaluation of LX-P 100 mg revealed differences between the samples, which were used to identify products with poor handling and sensation.  Thus, this study successfully demonstrated the usefulness of the criteria for the purpose of medicine selection.

著者

村上 雅裕 中谷 真由美 安田 恵 天野 学

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.3, pp.209-213, 2016 (Released:2017-02-14)

参考文献数

12

被引用文献数

1

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Objective: The squeezing force and one-drop weight, suggested to directly influence adherence, were measured in 6 eye drop products containing a switch OTC drug, ketotifen fumarate, to investigate useful information for product selection.Methods: The squeeze force, one drop weight, and pH were measured using a digital force gauge, analytical balance, and pH meter, respectively.  Information on additives contained in each product was collected from package inserts.  For the total number of drops, the number per 10 mL was calculated from the obtained value.Results: The maximum squeeze force was 14.8 N of Irice AG Guard, and the one drop weight (33.2 mg) of Raferusa®AL was the minimum.  The total number of drops per 10 mL was 215 in Sutto eyes Z, being the minimum.  The pH was in the range of 5.2-5.7.  On comparison of additives among the products, a cooling agent was contained in only 2 products.Discussion: Since the squeeze force was in the range of 5.3-14.8 N, it was less likely that the squeeze force reduces usability.  Since the one-drop weights of 2 products were more than 10 mg lower than the weights of the other products, the dose may be insufficient and the effect may not be attained.  The pH was within the acceptable range in all products.  Two products contain a cooling agent as an additive, and this has to be explained beforehand.  Information related to usability, actual feeling of the effect, and sense of the use of the products containing ketotifen fumarate was collected.

著者

布施 春奈 大西 優香里 松井 布美 杉山 奈津子 小茂田 昌代

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.2, pp.64-71, 2016 (Released:2016-09-27)

参考文献数

39

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Objective: Tamoxifen is a drug that is frequently administered for 5 years to treat hormone receptor-positive breast cancer in premenopausal women.  Metabolism of tamoxifen by cytochrome P450 enzymes such as CYP3A4 and CYP2D6 is required for drug efficacy.  However, reports suggest that the effect of tamoxifen is attenuated in the presence of CYP2D6 inhibitors.  In this study, I evaluated drug-drug interactions that may attenuate tamoxifen action for improved pharmaceutical management.Data Source: Potential interactions were evaluated by using the tamoxifen package insert, Kyoto Encyclopedia of Genes and Genomes (KEGG), Pharmaceuticals and Medical Devices Agency (PubMed), and Lexicomp Online.  We have searched the paper using the PubMed and JDream III.The Choice of Research: The paper about the interaction related CYP2D6 and 3A4 of tamoxifen.Results and Conclusion: The use of tamoxifen is often long term; however, adverse effects such as hot flashes, can cause poor regimen adherence.  Although selective serotonin reuptake inhibitors (SSRIs) can effectively treat menopausal hot flashes, many SSRIs inhibit CYP2D6.  In particular, paroxetine has been reported to adversely affect tamoxifen metabolism.  There are 31 drugs and 843 compounds that inhibit CYP2D6.  Thus, it is necessary to avoid these combinations.  In addition, there are many CYP2D6 gene polymorphisms that have been identified in Japanese patients, and some reports indicate that they affect tamoxifen efficacy.  Therefore, in order to continue use of these medications without attenuating the effect of tamoxifen, development of medical database which can be updated daily is required to avoid CYP-related interactions.

著者

掛谷 雅之 大津 史子 矢野 玲子 榊原 仁作 後藤 伸之

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.2, pp.70-80, 2014 (Released:2014-09-06)

参考文献数

23

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Objective: The present study investigated risk factors and subjective symptoms associated with drug-induced thrombocytopenia.Methods: We selected 361 patients with drug-induced thrombocytopenia from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database of over 65,000 case reports of adverse drug reactions and assigned these patients to a case group.  We also randomly selected 794 cases of adverse drug reactions not associated with thrombocytopenia as a control group.Results: Data were compared between the case and control groups, and results were analyzed using logistic regression analysis.  We identified type of infection (non-viral) and renal failure as risk factors for drug-induced thrombocytopenia.  In addition, administration of carbamazepine, methotrexate, interferon alpha, ticlopidine or valproic acid significantly increased the risk of drug-induced thrombocytopenia.  Significant associations were also found between drug-induced thrombocytopenia and purpura, fever, and mucosal bleeding.Conclusion: These findings provide helpful information for early detection and prevention of thrombocytopenia as a serious adverse drug reaction.

著者

鈴木 信也 川口 崇 猪狩 賢蔵 草野 淳一 安藤 栄輝

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.235-241, 2017 (Released:2017-03-17)

参考文献数

24

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Objective: Celecoxib has been reported to enhance the action of warfarin by inhibiting CYP2C9, its major hepatic drug-metabolizing enzyme, but sufficient information about the mechanism has not been obtained, especially in Japan.Methods: A study was conducted to investigate the prothrombin time international normalized ratio (PT-INR) and the warfarin sensitivity index (WSI) before and after concurrent administration of celecoxib, as well as the Drug Interaction Probability Scale (DIPS) scores to determine causality with drug interactions, in patients commencing concurrent therapy with celecoxib and warfarin at Kanagawa Prefectural Keiyukai Keiyu Hospital during the 4-year period from October 2011 to September 2015.Results: Analysis of 18 patients showed that the PT-INR increased significantly from 1.53±0.43 before concurrent therapy to 2.18±1.01 after concurrent therapy (p=0.0101).  The WSI also increased significantly from 0.76±0.50 before concurrent therapy to 1.01±0.65 after concurrent therapy (p=0.0044).  According to the DIPS scores, the causal relation was not rated as “Highly Probable” in any of the patients, while it was considered to be “Probable” in 3 patients, “Possible” in 10 patients, and “Doubtful” in 5 patients.Conclusion: The findings of this study suggested that when celecoxib treatment is initiated in patients who are already taking warfarin, attention must be paid to changes of coagulation profile, especially in elderly patients.

著者

下平 秀夫 野崎 真由 權 娟大 上村 直樹 海保 房夫

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.16-22, 2014-05-30 (Released:2014-06-09)

参考文献数

9

被引用文献数

5

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Objective: Recently, since usage of the kampo-medicines has changed from conventional usage, it is possible that the tendency of adverse reaction also changes.  Pharmaceuticals and Medical Devices Agency (PMDA) discloses information reported by Pharmaceuticals and Medical Devices Safety Information Reporting System.  In this study, we analyzed adverse drug events of kampo-medicines using Japanese Adverse Drug Event Report (JADER) database of PMDA.  We also investigated what adverse drug events are likely to be occurred by kampo-medicines and what kampo-medicine is likely to cause a particular adverse drug event.Methods: We focused on reports referring to suspected drugs for kampo-medicines from JADER database of PMDA for about nine years from April 2004 to February 2013.  We analyzed kampo-medicines, organs, and adverse drug events based on the number of reports.Results and Conclusion: We found 1,958 reports on adverse drug events for kampo-medicines.  The largest number of reports for kampo-medicines was on Shakuyakukanzoto, followed in order by Bofutsushosan, Saireito and Yokukansan.  The breakdown of each organ of adverse drug events reported was 34% for hepatobiliary system disorders, followed in order by 26% for respiratory, thoracic and mediastinal disorders, and 9% for metabolism and nutrition disorders.  A total of the above adverse drug events accounts for 70% of all adverse drug events.  The largest number of adverse drug events reported was 406 cases for interstitial lung disease, followed in order by 294 cases for liver disorder, 260 cases for hepatic dysfunction, 165 cases for hypokalemia, and 102 cases for pseudoaldosteronism.  There are many reports about pseudoaldosteronism of Yokukansan regardless of containing only 1.5 g ricorice per day.  As for cardiac disorders of Yokukansan, we need to pay attention to information in the future.

著者

飯久保 尚 青柳 吉博 浅田 和広 後藤 伸之 近澤 洋平 多田 公揚 柳瀬 秀明 若林 進

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.19, no.4, pp.149-157, 2018 (Released:2018-03-21)

参考文献数

7

被引用文献数

1

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Objectives: Many pharmaceutical companies provide information on prescription drugs on their websites.  These websites are popular search tools for drug information for many reasons, including the availability of information at all times.  However, there are various sources of confusion for users, such as the website content differing between companies.  Therefore, to improve the usability of websites created by pharmaceutical companies, we investigated the expectations and perceptions of website users of current websites and presented our results to website users and developers.Design: A questionnaire survey.Methods: Website users were surveyed using a questionnaire developed based on data obtained from a preliminary survey of drug information pharmacists registered at the Japanese Society of Drug Informatics.  Then, using data from the user survey, we conducted a survey of website developers for pharmaceutical companies.Results: When asked what makes the websites of pharmaceutical companies excellent, 55.7% of users responded “a website filled with information.”  When asked how the website of pharmaceutical companies should be structured, the most common answer was “searchability and visibility” in responses in free-description format (25.3%) and was “inter-company consistency regarding types of drug information available as well as the process required for obtaining drug information” for responses in multiple-choice format (88.6%).  When asked whether users were unable to obtain drug information when needed because user registration was required, 87.3% of the users replied affirmatively, although 47.1% responded that some content should require user registration.  Of website developers, 46.9% collected and analyzed information about users’ website use.  They also hoped to identify the users’ needs.Discussion: The findings suggest that the usability of websites could be improved by providing opportunities for website users and developers to exchange opinions and by standardizing the content of pharmaceutical company websites, including what information should require user registration.

著者

今井 志乃ぶ

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.3, pp.N42-N46, 2014-11-30 (Released:2014-12-21)

参考文献数

17

著者

田中 博之 篠原 悦子 佐藤 光利 石井 敏浩

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.1, pp.1-6, 2016 (Released:2016-06-13)

参考文献数

22

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Objective: The aim of this study was to review cautionary statements regarding hypersensitivity to drugs with a moiety similar to sulfonamide on Japanese package inserts.Methods: From approved drugs listed as of March 2015, we selected those with a moiety similar to sulfonamide and examined their therapeutic categories, together with the presence or absence, location, and wording of cautionary statements regarding usage, and matters pertaining to a history of drug hypersensitivity that was not limited to sulfonamide, on the package inserts.Results: We extracted 73 drugs (65 components) that included a moiety similar to sulfonamide.  Their therapeutic categories were diverse, and 39 (53.4%) had cautionary statements about hypersensitivity caused by a moiety similar to sulfonamide.  Among these 39 drugs, the cautionary statements were located in different sections (Contraindication 31, Careful Administration 4, and Important Precautions 4).  The cautionary statements showed differences in wording according to the individual drugs or positions.  For 10 of the drugs, information pertaining to a history of drug hypersensitivity not limited to sulfonamide was provided.Conclusion: Medical staff should recognize that package inserts are not standardized with regard to cautionary statements about hypersensitivity caused by moieties similar to sulfonamide, and that it is necessary to predict or judge the likelihood of cross-hypersensitivity reaction to such moieties on the basis of their chemical structure.  In addition, it is necessary to carefully observe the clinical condition of individual patients who are receiving drugs that have a moiety similar to sulfonamide.