Objective : Heparin lock flush solution is diluctes and divided into vials before its use while it is used in quantity in Japan. Then, we carried out the research on use of heparin lock flush solution.
Methods : We executed the nationwide questionnaire investigation concerning making heparin lock flush solution.
Results : The recovery of the nationwide questionnaire investigation was as high as 78% (64/82) indicating general concern for the problem.
Heparin lock flush solution was made in 97% (246/253) of wards. 69% (174/253) of wards had a standard for preparation. Therebon, it is thought that the standardization of heparin lock flush solution is possible. The use concentration employed most frequently for the peripheral intravenous injection was 10 units/ml and that for the central vein injection was 100/ml units. In many wards the amount used at 1 time for the peripheral intravenous injection was 5 ml or 10 ml and that for the central vein injection, was 5 ml, 10 ml, or 20 ml.
84% of nurses requested marketing of heparin lock flush solution.
Conclusion : We investigated the use realities and the problem of heparin lock flush solution from a past report etc. Heparin lock flush solution is listed to the pharmacopeia in the United States and Britain. Heparin lock flush solution should be supplied as the goods on the market immediately even if it is seen from the profit, the safety, the medical economy.

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Objective : Percutaneous ethanol injection (PEIT) for hepatocellular carcinoma is basic treatment of hepatocellular carcinoma. However, it is off-label uses to use ethanol for this treatment in the current state. Then, we executed the drug utilization study of Absolute ethanol injections at this time.
Methods : We executed the drug utilization study of Absolute ethanol injections at this time.
Results : The recovery of the questionnaire was high with 84.4% (151/179 medical institutions). The ethanol injections was made by 85% (129/151 facilities). Facilities where 100 or more ethanol injections was made annually were 76%. The raw material for making the ethanol injections was the reagent which was not the medicine in 44% of facilities. Information on safety and effectiveness concerning the ethanol injections was hardly offered from pharmacy. Finally, 96% (124/129 facilities) demanded marketing the ethanol injections.
Conclusion : We investigated the research report number by using “ICHUSHI” CD-ROM version (1988-1998) which was the medical literature data base. We were able to collect reports concerning PEIT of hepatocellular carcinoma of 636 reports. We were able to collect reports which used PEIT as a treatment method of hepatocellular carcinoma by as many as 636 reports. It has been understood that PEIT is enforced in Japan. Next, we reviewed the document and collected and evaluated information on effectiveness and safety concerning the ethanol injections used for PEIT. The treatment object, the usage, and the dosage have been decided at the relating academic meeting. Moreover, there was a report concerning a lot of effectiveness and safety in the PEIT treatment method of hepatocellular carcinoma. The ethanol injections used for PEIT is one of the medicines where information and scientific evidence concerning effectiveness and safety are accumulated. Moreover, a large amount of ethanol injections are nationally made in the pharmacy in the hospital. However, it has been proved that there are a lot of problems about the making. The ethanol injections is the medicine which should be supplied and made by the pharmaceutical company.

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Objective : To estimate the cost-effectiveness of using statins to prevent coronary heart disease (CHD) in men and women with hypercholesterolemia. Methods : A cost-effectiveness analysis of statins (such as, cerivastatin and pravastatin), by using “do-nothing” as a comparator, was conducted from a payer's point of view, based on a randomized controlled trial. By using a Markov model, life-time benefits (life-year gained) and costs were estimated. In the basic analysis, men and women of 50 years old with hypercholesterolemia (TC level ; 275 mg/ dl) were used. Both benefits and costs were discounted by 5% annually. The robustness of the model was tested by a sensitivity analysis.
Results : The cost per life-year gained with cerivastatin was ¥ 3, 480, 000 for men and ¥ 6, 340, 000 for women, respectively. The cost per life-year gained with pravastatin was ¥ 4, 650, 000 for men and¥ 8, 200, 000 for women, respectively. The incremental cost-effectiveness of cerivastatin compared with pravastatin was negative, indicating a low-cost and high-effect. A sensitivity analysis demonstrated the robustness of these results.
Conclusions : According to the Laupacis's criteria, cholesterol-lowering treatment by statins demonstrated the moderate evidence for adoption and appropriate utilization. Since this study is based on a small randomized controlled trial, several post-marketing surveillance studies will be necessary to confirm the validity.

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Objective : We studied the effective utilization of the community pharmacy-based prescription data for the event monitoring system in Japan, and attempted to evaluate the association between symptoms suspected of adverse drug reactions (ADRS) and the drug, inorder to improve the quality of ADR reports.
Methods : 1) The community pharmacy-based prescription data obtained from 98 patients to whom medicines were dispensed in a community pharmacy, were examined to select subjects who had discontinued drug treatment and to evaluate outcome after the discontinuation.2) In the cases who discontinued treatment, risk information (for example, timing from the onset of therapyto the appearance of symptoms, outcome after discontinuation, relapses and disease states, etc....) was collected from the prescription data. The association between the specific symptoms and the suspected drug was evaluated using the algorithm of Kitaguchi et al. (IYAKUHIN KENKYU 1983; 14 : 980-992).3) Also, the 98 patients were screened for subjective symptoms by interview using an ADR check list, and the cases that complained of symptoms of suspected ADRS were selected.4) In the selected cases, risk information was collected by talking with the patients, and the association between symptoms and the suspected drug was evaluated by this algorithm.
Results : 1) 16 cases with 26 symptoms had discontinued drug treatment. In these cases, the information related to the outcome after the drug discontinuation and disease states were obtained;not much information was available from the medication records. By using the algorithm, in 46% of the symptoms of these cases, the association between the symptoms and the drug was assessed as “possible”. Percentages of “definite”, “probable” and “remote” were 4%, 27% and 23%, respectively. 2) As a consequence of screening, 27 patients with 82 symptoms were suspected of ADRS. In these cases, there was little information related to timing, outcome and disease state. In fact, in half of the symptoms of these cases, the association between symptoms and the suspected drug could not be precisely determined.
Conclusion : For the purpose of improvement in quality of ADR reports, community pharmacies need to develop a good relationship with health care agencies or providers to share clinical information and risk informations, as well as, to collect the time course information related to ADRS from the appearance of the symptoms to disappearance after drug discontinuation. The event monitoring system in Japan does not require causality evaluations for suspected ADRS now, however, the intention to effectively evaluate causality will improve the usefulness of ADR reports.

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Objectives : High and medium-dose combination hormone agents have long been used in their off-label use as oral contraceptives. Oral contraceptives (the low-dose pill) are expected to be approved by the standing committee of the Central Pharmaceutical Affairs Council in June 1999, and are expected to be on the market by autumn, available to anyone bearing a doctor's prescription. A survey was conducted of pharmacy students to determine their acceptance and their perceptions of oral contraceptives (the low-dose pill). The results are discussed along with ways of dealing with the scientific information on the possible soon to be approved oral contraceptives (the low-dose pill), and some proposals are made for the future.
Methods : The survey was conducted by distributing questionnaire sheets to female pharmacy college students in September 1996. Of the 670 subjects, 98 responded positively to the use of oral contraceptives (the positive group), while 572 preferred not to use them (the negative group). The two groups were compared and the data was analyzed. Mantel-Haenszel test was used to evaluate demographic and background data, their views on using oral contraceptives (the low-dose pill) and ways of obtaining necessary information.
Results : In the responses to the questions on how the subjects feel about oral contraceptives (the low-dose pill), the positive group gave these reasons more frequently than those in the negative group : simple to use (p<0.001), a method with a high contraceptive rate (p<0.001), a means of contraception controlled by the woman (p<0.001). On the other hand, the reasons given more frequently by the negative group : feeling concerned about adverse drug reactions (p<0.001), a method allowing sexually transmitted diseases to propagate (p=0.009), a method increasing the burden on the woman (p<0.001).
In terms of the subjects' knowledge of oral contraceptives (the low-dose pill), although there has been some improvement observed during their four-year college life, they did not seen to understand accurate information.
Conclusion : The surveyed subjects had not understood accurate information, and this lack of knowledge may have formed their biased views on oral contraceptives (the low-dose pill). Given such results, it is anticipated that such misconceptions may affect their own decision-making in their use of the drug, and that it would cause inefficiency in providing future users with accurate information when these students become pharmacists. In the near future, there is expected to be a deluge of information concerning the low-dose pill. It is clearly necessary in pharmaceutical education to provide proper training of pharmacy students for self-education so as to increase efficiency when considering and evaluating information.

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A large-scale randomized prospective intervention study (Mega Study) was initiated by Ministry of Health and Welfare (MHW) Japan in 1993, and is on going with support from Sankyo Co., Ltd. This study is designed to test the hypothesis that reduction of serum cholesterol with pravastatin (a HMG-CoA reductase inhibitor) over an average of 5 years will reduce the incidence of fatal and nonfatal CHD (Coronary Heart Disease).
As a CRO (Contract Research Organization), we have set up a data center that is responsible for the conduction of this study. The main functions of the data center are to do patient registration, treatment randomization, clinical monitoring, data management, and statistical analysis.
This report outlines our some experiences with conduction of the data center, particularly relating to clinical monitoring, clinical data management, QA (Quality Assurance), and computer systems for such a data center.

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Post-marketing surveillance (PMS) of ethical drugs has been institutionalized in Japan. The framework of the PMS consists of : 1) collection of information related to the drug, 2) evaluation and analysis of that information, and determining the correspondence, 3) reporting the information and filing of applications of Reexamination/Reevaluation to the Ministry of Health and Welfare (the Koseisho), and finally 4) dissemination of information to medical and pharmaceutical professionals. Although a sphere of strict regulations is imposed for conducting these tasks, pharmaceutical companies comply with these regulations and execute post-marketing surveillance with an aim toward the true objective of the PMS, which is to “secure the proper use of ethical drugs”. In order to accomplish this objective, nothing is more important than for medical representatives (MR) to collect as much accurate information as possible, and for post-marketing surveillance management to conduct a precise evaluation and analysis of the collected information and then to feed back the pertinent information to medical and pharmaceutical professionals. With this in mind, pharmaceutical companies can be considered as conducting post-marketing surveillance systematically.

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