Japanese Journal of Drug Informatics
Online ISSN : 1883-423X
Print ISSN : 1345-1464
ISSN-L : 1345-1464
Volume 17, Issue 1
May
Displaying 1-8 of 8 articles from this issue
Review
  • Sho Ishikawa, Jun Saeki, Hiroko Toda, Tomohiro Ozawa, Masayoshi Hiroha ...
    2015 Volume 17 Issue 1 Pages 1-10
    Published: 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    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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Original article
  • Masahiro Nakayama, Masashi Hamada, Kayo Fukatsu, Muneo Kadobayashi, Ma ...
    2015 Volume 17 Issue 1 Pages 11-14
    Published: 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    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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  • Kouichi Hosomi, Mari Arai, Mai Fujimoto, Mitsutaka Takada
    2015 Volume 17 Issue 1 Pages 15-20
    Published: 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    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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  • Mitsuko Onda, Hirohisa Imai, Mika Kasuga, Mio Yasuda, Mamiko Shimomura ...
    2015 Volume 17 Issue 1 Pages 21-33
    Published: 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    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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Short communication
  • Yasuko Okumura, Masako Oda, Hiroshi Saitoh
    2015 Volume 17 Issue 1 Pages 34-38
    Published: 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    Objective: Consultation contents from medical consumers can become a useful information for medical workers.  However, report which investigated about them is limited.  In this study, we investigated the question contents from medical consumers with telephone.
    Methods: Nineteen hundred records on the consultation from medical consumers with telephone from 2007 to 2011 were subject to this study.  Using appropriate keywords and check the records, corresponding cases were extracted.
    Results: Resources of drug information which medical consumers used had various one such as the Internet, television, books, and newspapers.  However the medical consumers did not necessarily understand drug information correctly from the Internet and books.  This means that support by pharmacists was necessary in those cases.
    Conclusion: We think that information sharing in the medical consumers and medical workers based on a good relationship is important for proper use of drugs.
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Note
  • Tetsuya Ueki, Yoshiko Miyano, Yoshiko Sakamoto, Keiko Nagai, Yasuji Ha ...
    2015 Volume 17 Issue 1 Pages 39-44
    Published: 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    Objective: Information on medicines brought to hospital by inpatients is essential to optimize drug use and patient safety.  However, the actual situation and usefulness of identifying such medicines on the emergent admission of patients remain to be clarified.  The objective of this study was to examine the usefulness of identifying the medicines patients bring to the hospital on emergent admission.
    Methods: We compared the source of information on identifying medicines between two groups of patient: emergent admissions (N=276) and elective admissions (N=50), and also investigated intervention by pharmacists regarding the medicines patients had brought with them.
    Results: Regarding the source of information to identify the medicines, the rate of utilizing medicine notebooks on emergent admission was significantly lower than on elective admission, and the rate of inquiring with community pharmacies on emergent admission was significantly higher than on elective admission.  The frequencies of intervention by pharmacists in the two groups were similar, and, therefore, the usefulness of identifying the medicines patients brought was noted regardless of the admission course.
    Conclusion: Identifying the medicines patients bring to the hospital might be useful on emergent admission.  Hospital pharmacists should promote an increase in the medicine notebook utilization rate and reinforce cooperation with community pharmacies.
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  • Etsuko Kishikawa, Tadashi Yano, Satoshi Ichikawa, Muneo Miyasaka
    2015 Volume 17 Issue 1 Pages 45-52
    Published: May 30, 2015
    Released on J-STAGE: June 28, 2015
    JOURNAL FREE ACCESS
    Objective: Beginning in October 2014 a drug risk management plan (RMP) will be authorized as a condition for drug approval and for this and other reasons the role the medical representatives (MRs) play regarding drug information will become even greater. We therefore decided to conduct drug information awareness surveys of the MRs who visit our hospital.
    Methods: We first conducted a questionnaire survey on RMP, the Pharmaceuticals and Medical Devices Agency (PMDA), and postmarketing surveillance (PMS). Following the survey we held a seminar for MRs in relation to RMPs, after which we conducted a questionnaire again.
    Results: The surveys revealed that most of the MRs were not actively gathering information provided by the PMDA. They also revealed that after the seminar their knowledge regarding RMPs had increased and their understanding of the relationship between RMPs and PMS had deepened.
    Conclusion: Considering that the MRs gained a significantly deeper understanding after the seminar, participation by medical institutions, which are the recipients of the information, in the education of MRs can be said to be meaningful as a means of supporting proper information‐providing activities.
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