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Development and Evaluation of a Self-Learning Tool for Drug Information

Yumi Fukui ; Fumiko Ohtsu ; Nobuyuki Goto ; Masashi Ogawa ; Takafumi Ohta ; Nahoko Kurosawa ; Mayumi Mochizuki ; Yasuhiko Yamada

Japanese Journal of Drug Informatics.2015;16(4):193-200. doi:10.11256/jjdi.16.193

Objective: In pharmacy school, most faculty members use generic names when discussing medicine; however, in clinical clerkships, most staff members use brand names. This sometimes leads to poor communication and understanding between the students and medical staff.  The purpose of this study was to clarify the need for a tool to improve communication and understanding in relation to drug information.  Based on the findings of this survey, our secondary aim was to develop and subsequently evaluate such a tool.
Methods: To clarify the need for a self-learning tool, we conducted a questionnaire survey on 58 faculty members who teach courses on drug informatics.  Based on their responses, we then developed a self-learning tool that was subsequently evaluated by a total of 78 undergraduate students.
Results: Most of the faculty agreed concerning the necessity of a self-learning tool for drug information, particularly in regard to the establishment of a more user-friendly system and reduced user fees for students.  The faculty also believed that students should be able to associate the generic drug name with various kinds of information, including its safety, efficacy, and brand name.  All students agreed that the tool was helpful, very easy to use, and could be learned during their commute to school.
Conclusion: Our results suggest that most faculty members support the idea of having a tool capable of promoting a better understanding and grasp of drug information.  Therefore, our self-learning tool should be helpful in promoting increased knowledge concerning drug information for students in clinical clerkships.

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Submission Rates of Medication Notebooks in Insurance Pharmacies

Kazuki Ide ; Yoshihiro Ikumi ; Aya Kiuchi ; Junko Sone ; Makoto Kojima ; Hiroshi Yamada

Japanese Journal of Drug Informatics.2015;16(4):201-205. doi:10.11256/jjdi.16.201

Objective: To reveal the current use of medication notebooks in clinical practice and the differences in submission rates of medication notebooks among patients with different sociodemographic and medical characteristics.
Methods: We conducted a survey of the submission rates by studying the medication history, from June 19, 2014, to July 3, 2014.
Results: The overall submission rate of returning patients was 57.1% and the submission rate of patients who visit a single medical institution was significantly lower than patients who visit more than two (55.4% vs. 67.7%, p<0.001). Multivariate logistic regression also indicated significant differences between the single and multiple medical institution visit group (adjusted OR=2.74 [95% CI: 1.93-3.89], p<0.001). Submission rates for patients in their 20, 30, and 50 s who visit a single medical institution were lower than 40%.
Conclusions: To improve the usefulness of the community pharmacy and increase the submission rate, we need to increase awareness of the importance of medication notebooks among patients who visit a single medical institution. Additionally, future studies need to focus on factors such as age-related issues that might affect submission rates.

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Usefulness of Hospital Formulary and Required Drug Information as a Drug Therapy Reference for Medical Students during Clinical Training

Makoto Otsuka ; Tomoka Yamamoto ; Yoshihiro Kawahara ; Masayo Ueno ; Akie Arimoto ; Shoko Wakita ; Atsushi Washiyama ; Osamu Imakyure ; Koujiro Futagami

Japanese Journal of Drug Informatics.2015;16(4):179-185. doi:10.11256/jjdi.16.179

Objective: A hospital Formulary (HF) is useful not only for providing a list of formulary drugs, but also for drug safety management and clinical practice in hospitals.  Our Pharmacy Division serves as a clinical training facility for the Faculty of Medicine and offers a bedside learning (BSL) program that allows students to participate in medical services.  Providing medical students with a requisite understanding of pharmacotherapy in order to effectively provide medical services is the goal of the core curriculum of medical education and HF use in BSL may be effective in achieving this goal.  We conducted a survey in order to examine the usefulness of an HF for medical students during clinical training and to determine what drug information is required by students.
Methods: Between April 2012 and March 2013, a questionnaire survey was conducted on 88 fifth-year medical students    who participated in a 1-day BSL program using an HF.
Results: The response rate was 100%.  All students responded that they understood how to use the HF and believed it was useful in BSL.  However, the level of satisfaction with the explanatory notes was significantly lower than that of other sections providing clinically useful additional information such as monographs or supplementary tables (p<0.05).  More than 80% of the students considered monographs to be useful for obtaining information on side effects, warnings and contraindications, dosage and administration, indications, dosing in renal impairment, and drug name.  Students generally considered supplementary tables useful for obtaining information on serious side effects and their early identification, points of drug use in renal dysfunction, appropriate drug use in cancer chemotherapy, insulin and diabetes treatment, calculations of pediatric dosing, and a list of clinically used abbreviations.
Conclusion: These results suggest that medical students believe an HF is useful in BSL.  When medical students participate in pharmacotherapy during BSL programs outside the Pharmacy Division, an HF that not only lists drugs but also contains supplementary tables of clinically useful information may be required.

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Consumer Opinions on the Online Sales of Over-The-Counter Drugs

Shuki Fukushima ; Mitsuko Onda ; Mitsuru Nakazono ; Yuji Kawaguchi ; Syota Nakano ; Shingo Fujii ; Yuka Tanaka ; Yukio Arakawa

Japanese Journal of Drug Informatics.2015;16(4):186-192. doi:10.11256/jjdi.16.186

Objective: To identify consumer opinions on the online sales of over-the-counter drugs (“OTCs”) and related factors.
Methods: A Web survey of consumers was conducted. The main questions were: (1) Respondent attributes; (2) Frequency of purchasing OTCs; (3) Behaviors while in poor physical condition or while ill; (4) Experience of side effects; (5) Experience of purchasing health foods and OTCs online; (6) Opinion on online sales, and (7) The reasons for their opinion. Respondents were grouped into two categories based on whether they were for or against online sales in (6). The distributions of the answers to (1) through (5) from these groups were verified using the χ² test. Text mining was used to closely examine the answers to (7).
Results: 68.5% of the 2,609 respondents were in favor of online sales, with 31.5% against. Females and elderly respondents had higher rates of opposition. Consumers who frequently purchased OTCs, used drugs while in poor physical condition or while ill, and had experience purchasing health foods and OTCs online had higher rates of favoring it. The top reason for favoring online sales was “convenience,” while the main reasons for opposing it were “safety,” “difficulty in selection,” and “liability.”
Conclusion: Pharmacists will need to respond to consumer concerns when selling OTCs by developing the “ability to observe consumers’ condition and understand their concerns,” thereby improving their communication ability in face-to-face sales.

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Evaluation of Predictive Accuracy between Two Types of Vancomycin TDM Analysis Software

Shungo Imai ; Takehiro Yamada ; Ayako Nishimura ; Hiromitsu Oki ; Masayuki Kumai ; Takenori Miyamoto ; Kumiko Kasashi ; Ken Iseki

Japanese Journal of Drug Informatics.2015;16(4):169-178. doi:10.11256/jjdi.16.169

Objective: To attain optimal blood concentration rapidly, it is needed to perform initial dose setting appropriately when vancomycin (VCM) used.  In order to design initial dose settings of VCM more currently, we compared the predictive performance of two types of VCM therapeutic drug monitoring (TDM) analysis software retrospectively.
Method: We utilized two TDM analysis software, SHIONOGI-VCM-TDM ver.2009 (VCM-TDM) and “Vancomycin MEEK TDM analysis software Ver. 2.0” (MEEK), based on patient’s background. 112 patients who received VCM and performed TDM were analyzed during the period from October 2011 through September 2012 and compared the actual trough level with the predictive trough level.  The predictive performance was evaluated by calculating ME (mean prediction error), MAE (mean absolute prediction error), and RMSE (root mean squared error).  Age, gender, and a renal function were evaluated as patient’s background.
Results: VCM-TDM gave good predictive performance for patients overall.  When classified patient’s background complexly (sex, age, and renal function), as for male patients, VCM-TDM showed good predictive performance except for the group over 65 years old and CCr over 85 mL/min.  For female patients, the difference of predictive performance was not accepted by all groups.
Conclusion: These results suggest, for male patients, we should use VCM-TDM for initial dose settings except for the group over 65 years old and over CCr 85 mL/min.  For the other patients, we consider that both of software can be used.  These new findings seem to contribute to proper dosage settings of VCM.

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The Actual Status of the Provision of Drug Information in Clinical Clerkships and Development of an Online Self-Learning Tool

Akihiro Maenaka ; Fumiko Ohtsu ; Nobuyuki Goto ; Masashi Ogawa ; Takafumi Ohta ; Nahoko Kurosawa ; Mayumi Mochizuki ; Yasuhiko Yamada

Japanese Journal of Drug Informatics.2015;16(4):157-168. doi:10.11256/jjdi.16.157

Objective: The purpose of this study was to identify existing problems related to the provision of drug information in clinical clerkships.  In addition, we aimed to develop a self-learning tool based on our findings.
Methods: We conducted a questionnaire survey on students who had completed a clinical clerkship between December 2012 and February 2013 concerning the actual status of the provision of drug information.  Based on responses received from 86 students, we then developed an online self-learning tool.  This online tool was subsequently evaluated by the same 86 students.
Results: More than 20% of students surveyed reported never having made inquiries at their clerkship site; therefore, we developed an online self-learning tool for inquiry services in which students were able to learn step-by-step how to analyze, search, evaluate and provide inquiries.  A total of 89% of the students who tried this tool reported being satisfied with its use.
Conclusion: Our results suggest that students in clinical clerkships lack sufficient experience regarding drug information-related inquiries.  Therefore, our online self-learning tool should be helpful in promoting understanding of how to manage such inquiries for students in clinical clerkships.

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Exposure to Antineoplastic Drugs and Safe Handling from Literature Reviews

Sho Ishikawa ; Jun Saeki ; Hiroko Toda ; Tomohiro Ozawa ; Masayoshi Hirohara ; Kazuki Kushida

Japanese Journal of Drug Informatics.2015;17(1):1-10. doi:10.11256/jjdi.17.1

Antineoplastic drugs play an important role in cancer therapy. A growing number of patients and new fields of application have resulted in an increasing use of these agents. Most antineoplastic drugs are classified as carcinogenic, mutagenic, or teratogenic for humans. Antineoplastic drugs also cause adverse effects in health care workers who handle them. In the late 1960s, acute symptoms by exposure to antineoplastic drugs were first reported. In 1979, Falck reported a small increase in urine mutagenicity of nurse who handled antineoplastic drugs. Thereafter several studies showed that association of occupational exposure to antineoplastic drugs with health effects such as DNA damage, chromosomal abnormalities, adverse reproductive outcomes, possibly leukemia and other cancers. To prevent them, many guidelines for safe handling were published in various countries in 1980s, they are revised periodically afterward. In 1990s, despite recommended safe handling procedures, environmental contamination with antineoplastic drugs was still observed in hospital and health care workers were still exposed. In 2004, the National Institute for Occupational Safety and Health (NIOSH) published an Alert on hazardous drugs used in health care settings. One recommendation was to consider the use of closed system drug transfer devices (CSTD) in addition to ventilated cabinets. The effectiveness of CSTDs in reduction of environmental contamination and exposure of health care workers has been reported. Here this report briefly reviews the history of the health effects of exposure to antineoplastic drugs and of safe handling.

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Investigation of the Characteristics of Orally Disintegrating Film Formulation

Masahiro Nakayama ; Masashi Hamada ; Kayo Fukatsu ; Muneo Kadobayashi ; Masako Ohno ; Satoko Katsuragi ; Manabu Amano ; Masahiro Moriyama

Japanese Journal of Drug Informatics.2015;17(1):11-14. doi:10.11256/jjdi.17.11

Objective: In Japan, to prevent an increase in medical expenditure associated with development of super-aging society, the use of generic drugs is being promoted.  To help patients financially and meet their various other needs, generic drugs (e.g., orally disintegrating film formulations) whose dosage forms do not exist for original drugs are manufactured and distributed.  In this study, to evaluate the characteristics of an orally disintegrating film formulation, we performed dissolution, disintegration, and simulated intraoral tests of Amlodin® tablets 2.5 mg, Amlodin® OD tablets 2.5 mg, and Amlodipine OD film 2.5 mg that were manufactured by TEVA-KOWA PHARMA Co., Ltd.
Methods: Dissolution and disintegration tests were performed in line with the Japanese Pharmacopoeia, Sixteenth Edition, and the dose of amlodipine was determined by high-performance liquid chromatography.  During the simulated intraoral test, the tested drugs’ disintegration in purified water and artificial saliva was observed macroscopically, and recorded using a digital camera.
Results: Since the each formulation showed an over 85.0% rate of dissolution 15 min after the initiation of the dissolution test, no difference was found in elution behavior.  Also, in the simulated intraoral test, the film formulation began to disintegrate the earliest (2 and 10 min when using purified water and artificial saliva, respectively) among the tested drugs.
Conclusion: Our findings suggest that orally disintegrating film formulations show superior disintegration to uncoated or orally disintegrating tablets, and benefits on taking medicine was observed.

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Applied Data Mining of the FDA Adverse Event Reporting System, FAERS, and the Japanese Adverse Drug Event Report Database, JADER: Signal Detection of Adverse Events by New Quinolones

Kouichi Hosomi ; Mari Arai ; Mai Fujimoto ; Mitsutaka Takada

Japanese Journal of Drug Informatics.2015;17(1):15-20. doi:10.11256/jjdi.17.15

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.

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Examining the Effect of Pharmacists’ Visits to Homebound Patients on the Elimination of Unused Drugs

Mitsuko Onda ; Hirohisa Imai ; Mika Kasuga ; Mio Yasuda ; Mamiko Shimomura ; Natsumi Okamoto ; Yurina Takada ; Yoko Nanaumi ; Yuka Tanaka ; Yukio Arakawa

Japanese Journal of Drug Informatics.2015;17(1):21-33. doi:10.11256/jjdi.17.21

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.

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