Objective : There are two types of studies on the relationship between adverse events and genetic background and the relationship between constitution and genetic background.  To investigate the relationship between adverse events and constitution retrospectively, we first reviewed the appearance of the constitution responsible for the adverse events in the relevant sources of information.
Methods : Fifty two pharmaceutical interview sheets, 150 case reports and two manuals; “jyudaina fukusayou kaihi notameno fukuyaku sidou jyouhousyu”, “jyutoku fukusayou sikanbetu manual” were selected for review.
Results : Fourteen items about the constitution were found in the pharmaceutical interview sheets.  No items about the constitution were found in the case reports and manuals.
Conclusion : Rules for the preparation of pharmaceutical interview sheets and case reports to use the constitution information is necessary for retrospective analysis of this issue.

View full abstract

  In 2008, Japanese Society of Drug Informatics (JASDI) organized the Future Vision Committee (the Committee) to propose the essential focus of drug informatics.  To explore a future vision about the drug information sciences, it was necessary to collect a variety of opinions widely from researchers.  Therefore, at the 11^th annual meeting of JASDI in July 5-6, 2008, the Committee convened a workshop to extract problems in the researches of drug informatics by using KJ method and evaluated the contents.  The major problems raised were “the field of drug informatics is too broad” and “there is no definition and/or no system of the drug informatics”.  Related problems raised are the shortness of the history and lack of originality in the study.  From different viewpoints, it was also pointed out that the methodology of the research is not well established and no systematic education is provided.  Taken together, major problems in drug informatics are concluded to be the lack of definition and the lack of systematizations, and will be solved to a certain extent by defining the outcome of the researches in drug informatics.

View full abstract

Objective: The importance of self-supervised health care is growing.  In this field, we thought that pharmacists working in the community pharmacy or drugstore could play important roles in the health supervision of local residents, since they are familiar with community.  Here, we examined the effectiveness of “healthcare workshop” or “information service” by drugstore pharmacists on the consciousness of local residents regarding their health or the role of drugstore pharmacists as supporter of their medical health care.
Design and Methods: In the three branches of Yutaka pharmacy Ltd., we performed the “healthcare workshop” (4 times/ 6 months), “information service in regard to health or medical care” (about 10 times/day) and “distribution of medicine notebook” over 6 months.  To evaluate the effectiveness of these activities, the questionnaire was answered by the consumer in drugstores of the Yutaka pharmacy Ltd. before and after the “healthcare workshop” or “information service”.
Results: The recognition of pharmacist in the drugstore was significantly improved (before: 23.4%, after 39.1%).   In addition, the need of information service by drugstore pharmacists also increased from 62.5% to 76.1%.  Furthermore, the bringing ratio of medicine notebook and the percentage of submission of medicine notebook to doctors were increased from 52.1% to 61.5% and from 40.0% to 55.6%, respectively, while the possessive ratio of medicine notebook was not changed.
Conclusions: In the present study indicate that activities such as “healthcare workshop” and “information service” performed by pharmacists in drugstore are effective to provide many medical information extensively and to increase the need of information service by drugstore pharmacists in the local community.  In conclusion, continuance of these activities may important for drugstore pharmacists to be recognized as medical staff who support the health supervision of local residents in the future.

View full abstract

[Objectives] It has been demonstrated that HMG-CoA reductase inhibitors (statins) effectively reduce the low-density lipoprotein cholesterol (LDL-C) and total cholesterol levels in the blood, and currently, statins are most widely used for the treatment of hyperlipidemia.  On the other hand, it has been demonstrated that fibrates more effectively reduce the blood triglyceride level (TG).  However, concomitant use of statins and fibrates is contraindicated.
  Therefore, practical and situational use of fenofibrate (fibrate therapy) and atorvastatin (statin therapy) was investigated in patients with high TG and LDL-C levels in consideration of cost effectiveness.
[Method] Baseline TG and LDL-C levels were stratified, and a table of combination was prepared for TG and LDL-C values.  Effectiveness was measured by the number of patients who were able to achieve treatment targets.  Treatment targets were set referring to the reduction rate of serum lipid levels in dose finding studies of fenofibrate and atorvastatin and the target lipid levels identified in 2007 Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases.  Costs were measured by annual drug treatment costs, and the incremental cost effectiveness ratio of atorvastatin to fenofibrate was then estimated.  According to the actual patient distribution, the incremental cost effectiveness ratio of atorvastatin to fenofibrate in patients with TG level over 150 mg and LDL level over 140 mg was also estimated.
[Results] Fenofibrate was dominant over atorvastatin where effectiveness was higher and costs were lower in fenofibrate treatment in two patient groups; patients with LDL-C level under 160 mg patients with TG level over 170 mg and LDL-C level between 160 mg and 170 mg patients with TG level over 190 mg and LDL-C level between 170 mg and 180 mg patients with TG level over 230 mg and LDL-C level between 180 mg and 190 mg patients with TG level over 250 mg and LDL-C level between 190 mg and 200 mg patients with TG level over 290 mg and LDL-C level between 200 mg and 210 mg patients with TG level over 350 mg and LDL-C level over 210 mg.  In an analysis made according to the actual patient distribution, 571 fenofibrate patients and 534 atorvastatin patients were able to achieve the treatment targets, and fenofibrate was dominant over atorvastatin where effectiveness was higher and costs were lower in fenofibrate treatment.

View full abstract

Objective: The purpose of this study is to identify the problems in the adverse drug report (ADR) system in early post-marketing vigilance phase (EPM phase) in Japan.
Methods: The incidence of all ADRs and the ratio of serious ADRs were compared between the new drug application phase (ND phase) and the EPM phase.  The target medicines were Moxifloxacin (Avelox®tablets, 400mg), Gatifloxacin (Gatiflo®tablets, 100mg) and Prulifloxacin (Sword®tablets, 100mg).
Results: The average incidence of all ADRs in the ND phase was 100-fold greater than that in the EPM phase.  There were also 2-fold differences in the ratio of serious ADRs of individual medicines.
Conclusion: There are several problems with the ADR system in the EPM phase in Japan.  It is currently possible that the implementation of EPM will vary between in individual medicines and companies.  This suggests that the present data cannot be applied universally.  Thus, there is an urgent need to standardize the implementation of EPM.

View full abstract

Objective: In 2000, the Ministry of Health and Welfare issued an advisory that recommended intake of 0.4mg of folic acid in dietary supplements to reduce the risk of development of neural tube defects.  Since subsequent reports of questionnaire surveys by various investigators showed a low in the intake rate, we surveyed and evaluated the folic acid intake rate among the pregnant women consulting the Japan Drug Information Institute in Pregnancy.
Methods: We evaluated differences in folic acid intake rate according to the consulting women’s background factors. i.e., age, pregnancy planning, pregnancy history, and taking of anticonvulsant drugs in the 1053 women capable of participating in the survey among the 1061 pregnant women who requested a consultation with the Japan Drug Information Institute in Pregnancy between April 2006 and August 2008.
Results: According to the result of our survey, the intake rate of folic acid was 29% of the 1053 pregnant women.  The only 3 women of the 42 pregnant women taking anticonvulsant drugs took folic acid before they got pregnant.
Conclusion: Even now, 8 years after the Ministry of Health and Welfare advisory, the folic acid intake rate is low.  Drawing upon successful measures promoting intake in the U.S. and Canada,we play a vital role in delivering this critical health information to pregnant women.

View full abstract

Objective: To quickly collect and provide information on package insert revisions, packaging changes, discontinuation of drug manufacturing and distribution, and other information without fail.
Methods: Information was collected with the use of a drug information service site (SAFE DI) managed by an organization formed by 15 pharmaceutical wholesalers (SAFE Co., Ltd.).  The information obtained was processed into a house journal and provided to the department of pharmacy and other hospital personnel via an employees-only website (hospital LAN).
Results: Before the introduction of the SAFE DI, incomplete or delayed information collection sometimes forced personnel to urgently cope with packaging changes or discontinuation of drug manufacturing and distribution and assume a heavy workload.  Introduction of the system allowed quick collection and dissemination of such information without fail.
Conclusion: The recently introduced SAFE DI contributes to qualitative improvement in collection and dissemination of information.  Introduction of such a system may also be useful in other hospitals.

View full abstract