薬剤疫学
Online ISSN : 1882-790X
Print ISSN : 1342-0445
ISSN-L : 1342-0445
3 巻, 1 号
選択された号の論文の10件中1~10を表示しています
  • 清水 直容
    1998 年 3 巻 1 号 p. 3-9
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
  • 吉田 茂昭, 土門 常多
    1998 年 3 巻 1 号 p. 11-16
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Objective and Data Sources : To clarify where the crux of the problems lies in general usage of anticancer drugs in Japan, we examined the tracking reports on leading products in cancer market during 1994-1996. The results obtained were compared with 1995-6's actual purchase in National Cancer Center (NCC), Japan, and those in 1996 from the M. D. Anderson Cancer Center (MDACC), USA.
    Results : In Japan, oral agent of fluoropyrimidine such as UFT, doxifluridine (Furtulon), or 5-FU tablet, immunopotentiator such as Picibanil or Krestin, and anticancer hormonal agents accounted for approximately 70% of the market. As a result, the cytocidal anticancer injections which should be the leading agents for cancer chemotherapy are in the minority. In contrast, the actual purchase of NCC revealed that approximately 85% was for the cytotoxic injections and it was nearly the same with MDACC. In spite of this, the actual purchase for granulocyte colony stimulating factors (G-CSF) and antiemetics such as granisetron was so much larger in MDACC (30% of the total) that in NCC (7% of the total).
    Conclusion : The special circumstances in Japanese market reflects the poor development of medical oncology in this country where the truth-telling is uncommon, and less toxic chemotherapy is chosen without considering how much actually effective. Although, on the other hand, the similarity in NCC and MDACC indicates the expertness of cancer treatment, so big expense for G-CSF and antiemetics in USA makes us consider the importance of the rationalization for their usage in toxic chemotherapy in Japan.
  • 木村 哲
    1998 年 3 巻 1 号 p. 17-23
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
  • 鹿児島大学医学部附属病院の薬剤使用をめぐって
    熊本 一朗
    1998 年 3 巻 1 号 p. 25-30
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Objective : To examine past and present status of polypharmacy, multiple drug therapy, and drug utilization survey of the antibiotics.
    Design : Drug utilization survey using the database of the Kagoshima University Hospital information system.
    Methods : Data of the presriptions issued during every May between 1985 and 1997 were extracted from the database. Monthly prescriptions were classified by the number of the drugs they included. And the doses of the antibiotics were summed up yaerly.
    Results : During thirteen years between 1985 and 1997, the proportion of patients receiving ten drugs or more also increased from 1.50% to 4.89%. The annual utilization doses of the antibiotics are gradually decreased. For the drug utilization review the database of the hospital information system are the useful resources.
    Conclusion : The billing and acounting database in the hospital information system have a few problems as the reseach data sources. On the other hand, the drug history database to which are individually transfered from the prescription order entry database in hospital information system, are able to be adaptated to the research in pharmacoepidemiology.
    The hospital information system including the clinical subsystems are routinely operated and a large amount of the clinical patient data are daily archieved. For this reason the drug history database are able to combine and link to the other clinical database in the hospital information system such as the clinical laboratory results or the diagnosis data. These linkage database in hospital information system are virtual pharmacoepidemiology database and the useful research resources in pharmacoepidemiology.
  • 上田 慶二, 清水 直容, 吉田 茂昭, 木村 哲, 熊本 一朗
    1998 年 3 巻 1 号 p. 31-37
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
  • 宮地 典子, 奥隅 貴久美, 古川 広志, 佐竹 尚子, 片平 洌彦
    1998 年 3 巻 1 号 p. 39-45
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Objective : To analyze serious adverse drug reactions (ADRs) in terms of their occurrence, the related factors and the necessary means to avoid such ADRs, and proposal of possible preventive measures against ADRs.
    Design : Case series.
    Methods : Out of 598 cases collected through an in-patient drug monitoring conducted from April 1990 to March 1996 in Hospital T, 59 cases which were of Grade 3 of the Ministry of Health and Welfare Standards for Severity Classification of ADRs were selected for this study. By classifying the causes of and the possibilities to avoid reactions in 59 cases, we discussed measures to prevent serious reactions to drugs.
    Results : Symptoms involved were, in descending order, hypersensitivity, hepatic disorder, blood disorder, renal failure, cadiovascular system disorder, and other symptoms. Causal drugs were, in descending order, antibiotics, central nervous system drugs, circulatory drugs, gastrointestinal drugs, and other drugs.
    Regarding the causes for the ADRs, factors involved in “usage”, such as indication and dosage, represented the highest rate, 40.7%. In a detailed survey of the possible avoidance of such reactions, 49.2% of serious ADRs were judged preventable by careful administration of the drugs. Further, 15.3% of the cases were thought to have resulted from a lack of or an inadequate description in the package insert.
    Conclusions : The study indicates that the following steps are necessary to prevent ADRs. : (1) To be appropriately cautious to indications and dosages of the drug (including, in particular, indications and dosages for the aged, and renal failure or allergic patients, and the adjustment of dosage on the basis of drug-drug interaction); (2) To adhere strictly to contraindication ; (3) To offer suitable information on the ADRs to the patient who has experienced such a reaction ; and, (4) To be aware of unusual conditions by careful follow-up at an early stage after the administration.
    The following action plans were considered important for carrying out the steps mentioned above : 1) to deepen medical workers awareness to prevent ADRs ; 2) to establish a system that can correctly offer fundamental and essential information to physicians ; 3) to standardize drug treatment according to patient condition (age, renal-failure, etc.) and to establish a safety assurance system.
  • 大山 良治, 小出 大介, 浜田 知久馬, 矢船 明史, 久保田 潔, 大江 和彦, 伊賀 立二
    1998 年 3 巻 1 号 p. 47-59
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Objective : To know how to conduct good pharmacoepidemiology studies using hospital-based database in Japan.
    Methods : Medical records during 15 months January 1996 and March 1997 in the University of Tokyo Hospital Information System (HIS) are examined know whether it is possible to conduct pharmacoepidemiology studies similar to previous studies on asthma drugs (Spitzer et al, 1992) and calcium antagonists (Psaty et al, 1995). To know the stability of population covered by HIS, the following two intervals are calculated for ambulatory patients with asthma and hypertension ; 1) average intervals of successive two outpatient visits and 2) intervals between the last day of outpatient visit and the last day of observation.
    Results : The size of possible pharmacoepidemiology studies attainable using HIS is judged to be more than 5% of previous studies in Canada and America. Average intervals of successive two outpatient visits are estimated to be 30 days or less for 59% of 693 asthmatics and 77% of 2842 hypertensives. For 48% of asthmatics and 71% of hypertensives, intervals between the last day of outpatient visit and the last day of observation are estimated to be 30 days or less.
    Discussion : To attain a size appropriate for pharmacoepidemiology study, researchers must cooperate across hospitals. Although a patient can visit any hospital anywhere under Japanese comprehensive medical care plan, it seems that patients tend to become to visit one particular hospital. However, additional information on medical care in other hospitals is needed for each study subject.
    Conclusion : Japanese hospital-based database is suitable for pharmacoepidemiology studies as a record during a long time period is usually available for a large fraction of patients with a particular disease. The study may be free from some of biases closely associated with referral processes known to occur in hospital case-control studies. A design of case-control study selecting patients with long medical records across 5-10 hospitals is probably the most promising when using Japanese hospital-based databases.
  • 加藤木 好雄
    1998 年 3 巻 1 号 p. 61-70
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Objective : We sent out a questionnaire to major European pharmaceutical companies in attempt to determine the actual situation of European pharmacoeconomical activity.
    The questionnaire is expected to provide information which would be useful, when we, Japanese pharmaceutical companies monitor pharmacoeconomical activity to observe and estimate how the Japanese medical system is now changing and will change in the future.
    Methods : The questionnaires were sent directly to the headquarters in Europe or to subsidiaries of multinational companies which have their subsidiaries in Germany, the UK and France.
    Results : It was clear that there is no legal obligation to submit a pharmacoeconomical report as data for filing as a new drug and/or for filing for official drug price list in Germany, the UK and France. Of the three countries, the report made the best use of sales promotion in the UK. On the other hand, it was the least used in Germany.
    In France, the major purpose of the report was to explain to governmental authority the reason why the price for a new drug was set as such.
    Conclusion : Each country's pharmacoeconomical activities as surveyed by its pharmaceutical companies has particular characteristics. The contents of the activity depends on what type of users there are, for example, governmental administration, medical institution, health insurer etc. and it also depends on the expectations of the social environment regarding the economy and efficiency of medical treatment.
    It is necessary for us, Japanese pharmaceutical companies to have great considerartion for such social environment, when we consider pharmacoeconomical activity in Japan.
  • PCを用いて開始したケーススタディ
    渡辺 素子, 津谷 喜一郎, 山本 美智子
    1998 年 3 巻 1 号 p. 71-77
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Background : As the consequence of the decision at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) progress, drug safety information reporting system in Japan is being revised. This has led to inevitable increases in the number of safety reports submitted to the industries and in turn, the Ministry of Health and Welfare (MHW). In 1997, the MHW announced they would publicize this acquired information starting in 1999. In the USA, Food and Drug Administration (FDA) has released safety related information to the public, acquired over the years since 1969, though such means in the Web page of MEDWatch using the internet.
    Purpose : (1) To review accessibility of individual adverse experience (AE) reports in MEDWatch through internet, (2) to give advise to other possible Japanese users on the use of it and, (3) to give recommendation to the new system being developed in Japan by the MHW and/or other regulatory agency.
    Method : Case study started by using personal computer.
    Results : (1) The information cannot be accessible only using personal computers. Computer expert assistance and big computer are needed to access the information. (2) Information from more than a million AE cases is accessible. (3) Searches for information can be organized by pharmaceutical name, event term, patient demographics, and others. (4) The detailed information such as the course of the individual case from which drug causality could be assessed is not accessible. (5) The improvement of system should be needed for easy access such as “quick search”. (6) More “user friendly” system is desired to be developed by the MHW and/or other regulatory agency in Japan which enable easy and full access of the information.
  • 岡本 悦司
    1998 年 3 巻 1 号 p. 79-82
    発行日: 1998/05/31
    公開日: 2011/02/28
    ジャーナル フリー
    Background : Health insurance claims contain invaluable data for epidemiological survey. However their use for research purposes has been hampered by both bureaucratic red-tape and technical limitations. These include the lack of legal rationale for disclosure and the lack of electronic data transfer. In response to the recent advancement in these field, such as the governmental policy change to allow disclosure of the claims to patients and a rapid computerization of the claims, researchers interested in health insurance claims held liaison meetings to exchange views and know-hows to facilitate the epidemiological research using health insurance claims.
    Reports on the Meeting : The liason meetings have so far been held twice as part of Japan Public Health Association annual assembly, at Yamagata in 1995 and at Yokohama in 1997, both sponsored by the author. Fourteen researchers presented their research activities using health insurance claims and discussed with the attendants on their experience to overcome the bureaucratic red-tape and technical limitations. Two of the presenters beside the author were pharmacoepidemiologists : Dr. Hayashi addressed the value and possibilities of the claims as data source for pharmacoepidemiology and Dr. Kubota proposed PEM (Prescription Event Monitoring) using health insurance claims as triggers to complement the present voluntary ADR reporting.
    Implications : Since the bureaucratic and technical obstacles may be better handled through a coordinated and liaisoned action of the researchers, it is necessary to form a consortium of researchers and professionals who have any interest in health insurance claims regardless of their purposes and make guidelines and recommendations to assure legitimate and appropriate utilization of the potentially sensitive but useful individual information.
feedback
Top