Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
Online ISSN : 1882-790X
Print ISSN : 1342-0445
ISSN-L : 1342-0445
Volume 2, Issue 2
Displaying 1-6 of 6 articles from this issue
  • Satomi MUKAIDE, Yasuo OHHASHI, Noriaki NAKATANI, Kazuo SAMIZO
    1997 Volume 2 Issue 2 Pages 69-80
    Published: October 31, 1997
    Released on J-STAGE: February 28, 2011
    JOURNAL FREE ACCESS
    Objective : To evaluate communication effects of the intervention by written risk information on prescribed drugs and explore the influencing factors.
    Design : A randomized prospective controlled trial.
    Setting : An outpatient unit in a medical center.
    Patients : 243 outpatients prescribed antihypertensive drugs.
    Intervention : Patients were randomized into either the study or control group. The study group received sheets showing risk information in addition to drug's name and efficacy while the control group received those without risk information. Patients were requested to complete a questionnaire before and 1 month after receiving information.
    Main outcome measures : The communication effects, defined in terms of patient satisfaction, helpfulness of the sheets, reassurance about taking drugs and compliance evaluated by himself.
    Results : Of 243 patients, 123 completed the second questionnaire. Of those 123, the study group patients were significantly more satisfied (p=0.035). For other 3 measures, there were no significant differences between the study and control groups. But almost all patients regarded the sheets helpful. After receiving the sheets with or without risk information, 67 (61.5%, 109 answered) were reassured and the compliance was said to be improved with 32 (28.1%, 114 answered).
    From the exploratory analysis of 112 patients having completed both questionnaires, patients who evaluated the sheets helpful tended to be more reassured. The compliance of patients who were reassured tended to be better.
    Conclusion : Patients regarded the written drug information as a helpful medium and were more satisfied with risk information. Irrespective of whether risk information was included, reassurance and better compliance were attained by the written drug information.
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  • Yukari YAMAMOTO, Hitoshi SATO, Hiroshi INOUE, Ryuichi HAYASHI, Hideki ...
    1997 Volume 2 Issue 2 Pages 83-89
    Published: October 31, 1997
    Released on J-STAGE: February 28, 2011
    JOURNAL FREE ACCESS
    Objective : To examine the association between the combination therapy of calcium antagonists with angiotensin converting enzyme (ACE) inhibitors and underlying diseases for hypertensive patients.
    Design : Cross-sectional survey of the drug utilization.
    Methods : This survey included 603 hypertensive patients who had visited Toyama Medical and Pharmaceutical University Hospital, Toyama, Japan more than twice from January to June in 1996 and received the prescriptions of calcium antagonists and/or ACE inhibitors. Main outcome measure was the combined medication of calcium antagonists with ACE inhibitors. Underlying diseases under consideration were diabetes mellitus (DM), hyperlipidemia (LIPID), ischemic heart disease (IHD), chronic heart failure (CHF), and ischemic stroke (STROKE).
    Results : Out of 603 hypertensive patients, 57.5% received only calcium antagonists, 23.7% received only ACE inhibitors, and 18.7% received both of them. Patients with either IHD or CHF tended to receive the combination therapy as compared to DM or LIPID. Although men tended to receive the combination therapy, a gender effect might be a confounder for the association. Logistic regression showed a 33% increase (P=0.265) in frequency of the combination therapy in patients with IHD after adjusting for age and gender.
    Conclusion : Some underlying diseases were associated with more frequent prescriptions of the combination therapy for hypertensive patients, especially with ischemic heart diseases. This result should be regarded as an exploratory stage although the pattern of antihypertensive drug use could be reasonably explained from the pharmacological sense.
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  • Chisato HAMASHIMA, Syunya IKEDA, Naomi IKEGAMI
    1997 Volume 2 Issue 2 Pages 91-101
    Published: October 31, 1997
    Released on J-STAGE: February 28, 2011
    JOURNAL FREE ACCESS
    Objective : The economic aspect of pharmaceuticals is becoming a major issue of health care financing in Japan due to the high total volume of drug consumption. To consider the feasibility and usefulness of pharmacoeconomic (PE) studies in health policy making, we aimed to conduct a review of PE studies published in Japan.
    Methods : We collected original published PE studies conducted in Japan from 1985 to 1995, by retrieving through computer databases such as MEDLINE and JMEDICINE, as well as other methods. We then reviewed the papers according to a checklist developed by Drummond et al.
    Results : Fourteen articles were found to satisfy the inclusion criteria. The overall checklist compliance rate were 45.8%. All of the PE studies were based on randomized clinical trial. Most of the studies lacked some important elements of PE analysis, such as the identification of all important and relevant costs and consequences (14.3%) and the presentation of all issues of concern (7.1%). Furthermore, most models and assumptions used in the studies were considered by us to be unreliable and inappropriate.
    Discussion : The quality of PE studies conducted in Japan was not considered by us to be satisfactory and our analysis identified areas for improvement. Further improvement in this field is urgently needed and may be achieved through PE guideline development and the training of specialists.
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  • Yutaka NOJIMA, Takeshi MAYAMA, Hiroshi FUKUSHIMA, Tadashi KUSUNOKI
    1997 Volume 2 Issue 2 Pages 103-110
    Published: October 31, 1997
    Released on J-STAGE: February 28, 2011
    JOURNAL FREE ACCESS
    Spontaneous reporting system of adverse reactions (ADRs) is indispensable to secure drug safety. Although good systems of western countries are well-known in Japan, it seems that the French pharmacovigilance system is not familiar, as compared with the yellow-card system in the UK and the MEDWatch program in the US.
    This report outlines various features of the French system according to our information collected by a visit to the French medicines agency and one of the regional centers. The “good pharmacovigilance practices, ” enforced by the agency in 1995, is used as a reference.
    Notable features are summarized as follows : (1) decentralized activities by the 31 regional centers collecting spontaneous ADR reports from healthcare professionals, (2) centralized EDP-system retaining ADR data, (3) official decision-making process called “inquiry”, which opens when a signal of safety issues comes up, and synthesizes a consensus and proposal on necessary measures, (4) bidirectional communication between the regional centers and prescribers, reporting ADRs and providing safety information by Q & A, (5) collaboration of specialist committees and pharmaceutical companies with the above elements, and so forth.
    The system is characterized by these elements constructing collectively an effctive system to prevent ADRs and reduce the seriousness. These findings will be helpful, even in Japan, when subjects for improvement of a reporting system are discussed.
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  • Kiyoshi KUBOTA, Daisuke KOIDE, Chikuma HAMADA, Akifumi YAFUNE
    1997 Volume 2 Issue 2 Pages 111-130
    Published: October 31, 1997
    Released on J-STAGE: February 28, 2011
    JOURNAL FREE ACCESS
    Background : In Japan most (>85%) voluntary reports on suspected drug reactions are collected by drug companies.
    Objective : To know various aspects of case reports on suspected drug reactions collected by Japanese drug companies.
    Methods : Questionnaires were designed by our department and mailed to 96 major drug companies in late March 1997. They were reminded in mid-May and mid-June when not having responded.
    Results and Conclusion : Of 96 drug companies, 3 were found to be not eligible (e. g., selling only the OTC drugs) and excluded. Of the remaining 93 companies, 91 (98%) responded. Of all the case reports collected by drug companies (approximately 27, 000/year), 36%of serious or important cases are duly reported to Ministry of Health and Welfare (MHW) within 15 days or 30 days of receipt. In Japan individual case reports collected by drug companies and reported to MHW have been closed. Eleven companies are opposed to disclosing individual case reports while 6 agree unconditionally. Seventy companies agree to disclosing individual case reports with various conditions such as protecting patients' privacy, not disclosing the reporter's identity, and making individual case reports available to medical personnel only. Finally, 20 of 91 drug companies complained that MHW does not let them know individual case reports associated with their own products sent to MHW directly from medical doctors or via other companies. To promote pharmacoepidemiology, disclosing voluntary reports is pivotal and MHW is going to adopt this policy in two years for which however reporters and drug companies must be prepared in advance.
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  • Kiyoshi KUROKAWA, Yasuo OHASHI, Kanemi KAWABE, Kiyoshi KUBOTA, Yasuo K ...
    1997 Volume 2 Issue 2 Pages 131-144
    Published: October 31, 1997
    Released on J-STAGE: February 28, 2011
    JOURNAL FREE ACCESS
    Background : With a suppport from Ministry of Health and Welfare (MHW) Japan, we studied the feasibility of conducting event monitoring in Japan similar to Prescription-Event Monitoring in England. The manuscript presented is a report to MHW in 1996.
    Methods : Means available in Japan to identify drug, patient and doctor are examined. In addition, any modification needed to make on a questionnaire sent to doctors in PEM conducted in Japan is examined.
    Results and Conclusion : Monthly claims called as “Rezept” issued by individual hospitals and clinics and sent to insurers and outpatient prescriptions issued by hospitals to be dispensed by the pharmacies outside the hospitals are considered to be two available means to identify drug, patient and doctor. To have a sample representative of all drug users, the use of “Rezept” is needed as only a fraction of outpatient prescriptions are dispensed by independent pharmacies. However, the use of prescriptions dispensed by the independent pharmacies together with the cooperation of individual pharmacies is capable of finding a contemporary control which is a group of patients who have recently started “old” drugs comparable to the new “test drug”. In Japan no doctor may have a complete list of the hospitals and clinics a patient has visited and it is mandatory to ask doctors the last date when the patient visited the doctor. To clarify what problems arise when a PEM-like study is introduced to Japan, a pilot study is going to be done during 1997 and the feasibility will be examined further based on the results.
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