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Objective: We have developed an automatic vigilance system (AVS) that automatically reports adverse drug reactions (ADR) based on laboratory finding abnormalities and symptom keywords in electronic medical records. In this study, we aimed to evaluate the impact of detecting ADR using AVS on medical treatment.Methods: In AVS, drugs and their ADR signals, which would be detected and reported by AVS to pharmacists, were defined. Pharmacists evaluated the severity of these signals to identify whether these signals should be discussed with the doctor, continued to be followed up, or ignored. We investigated detection of ADR at University of Fukui Hospital between April 2016 and March 2017 along with whether prescriptions were modified because of ADR and the contribution of AVS. Assuming that ADR had worsened without appropriate treatment, medical expenses needed for treating severe ADR were calculated.Results: In total, 325 signals were defined for 146 drugs. There were 9,103 ADR signals confirmed by pharmacists for 8,531 subjects. Of these, 12 and 164 signals were discussed with the doctor and continuously observed, respectively. The pharmacist's suggestions based on AVS led to prescription modifications in 10 cases, corresponding to a reduction of 2.56 million yen in medical expenses in the event that these cases become severe.Conclusion: AVS assisted prescription revisions because of ADR and is thought to contribute to the prevention of worsening of ADR and reduction of medical expenses.
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<b>Objective</b>: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.<br><b>Method</b>: Among all of the newly approved medicines in Japan in 2010, 12 marketed products in the U. S. are selected. First, to examine the U. S. system, post-marketing safety concerns over those drugs at the time of approval in the U. S. were collected as well as its postmarketing requirements (PMR) which are studies or clinical trials that sponsors are required to conduct under one or more statutes of regulations. Then, the same drugsʼ safety issues discussed as special cautions listed during the approval process in Japan and the corresponding postmarketing safety studies were reviewed.<br><b>Result</b>: Both countries have many safety concerns in common, however, in Japan, ongoing studies are only conventional studies, such as post-marketing surveillance studies or all-cases studies, while the U. S. conducts studies to meet each individual requirement need. Ideal post-marketing safety study designs proposed by the task force, seemed beyond sponsors capabilities, particularly with regard to conduct studies with control group, and require involvement of academia external research organizations, or establishment of the national registry system for cancer and other major diseases.<br><b>Conclusion</b>: In Japan, Risk Management Plan (RMP) will soon be implemented in 2013, and that is expected to secure patientsʼ safety by the scientific pharmacovigilance plan with the international standard. It is an urgent task to discuss what plan is feasible in Japan and how to make the corporation of industry-government-academia a reality. (Jpn J Pharmacoepidemiol 2012; 17 (1): 55-66)
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<b>Objective: </b>In recent years, the Ministry of Health, Labor and Welfare has actively promoted the use of generic drugs. However, implementation of this policy has not progressed smoothly, as information on generic drugs is poorly organized. As a result, it is difficult for pharmacists to select the appropriate generic drugs. Therefore, we attempted to develop a code system to organize information on generic drugs.<br><b>Methods: </b>We analyzed the guidelines used for the approval of generic drugs. We then identified the important aspects for comparison of generic drugs and developed a code system. Next, we tested this code system using temocapril hydrochloride tablets, which is a generic drug.<br><b>Results: </b>We were able to develop a code system for selection of generic drugs. Furthermore, we confirmed the utility of this code system for selecting generic drugs in the case of temocapril hydrochloride tablets.<br><b>Conclusion: </b>We believe that this code system with be useful for pharmacists, but further development is necessary for other generic drugs.
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<b>Objective: </b>In recent years, the Ministry of Health, Labor and Welfare has actively promoted the use of generic drugs. However, implementation of this policy has not progressed smoothly, and generic drug companies suggest that this is because medical staff and patients are not properly informed. We examined pharmacists’ knowledge and opinions concerning generic drugs.<br><b>Methods: </b>We conducteda questionnaire survey to determine community pharmacists’ opinions and understanding with regard to generic drugs.<br><b>Results: </b>About 90% of pharmacists were apprehensive about the use of generic drugs. All pharmacists scored low on factual questions, answering an average of 40 % correctly. The question about the bioequivalence evaluation method in particular was poorly answered. However, pharmacists’ anxiety about using generic drugs was not related to their knowledge.<br><b>Conclusion: </b>Our findings suggest that community pharmacists lack sufficient knowledge about generic drugs. It is therefore necessary to educate them on the use of generic drugs. Also, in order to allay pharmacists’ fears, it is important to improve the comprehensiveness of information concerning generic drugs.
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For the purpose of pharmacists to be able to be more involved clinically, the pharmacy education system in Japan was revised in April 2006 and the term length of pharmacy education was extended from 4 years to 6 years.<Br> The Japanese Society for Pharmacoepidemiology is deeply concerned about the new curriculum which will be adopted for the 6-year course, especially the handling of pharmacoepidemiology education. Two questionnaire surveys were sent to the dean of all schools of pharmacy to inquire whether they lecture pharmacoepidemiology and, if not, what study in pharmaceutical sciences would be most closely related to pharmacoepidemiology. The surveys were conducted just before and just after the introduction of the new system, in October 2005 and July 2007. The recovery of the first and second survey were 90% and 76%, respectively.<Br> In the first survey only 17 universities (31%) had lectures on pharmacoepidemiology but in the second survey 31 universities (57%) did, and in 55% of these 31 universities the lecture was required. The result indicates that the understanding of professors of pharmacy school regarding the lecture have been gradually promoted and they feel that pharmacoepidemiology is going to be considered to be one of the essential lectures in pharmacy education in Japan. However, many responders indicated that pharmacoepidemiology was still an immature field of study and there are few appropriate textbooks and no teaching experts, and therefore, the society should take these matters into reconsideration.
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<b>Objective: </b>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.<br><b>Methods: </b>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).<br><b>Results: </b>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.<br><b>Conclusion: </b>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.
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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. <BR>Methods : We executed the drug utilization study of Absolute ethanol injections at this time. <BR>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. <BR>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 : 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.<BR>Methods : We executed the nationwide questionnaire investigation concerning making heparin lock flush solution.<BR>Results : The recovery of the nationwide questionnaire investigation was as high as 78% (64/82) indicating general concern for the problem.<BR>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.<BR>84% of nurses requested marketing of heparin lock flush solution.<BR>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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Background : A vitamin K<SUB>2</SUB> agent has recently been approved and is going to be marketed for the treatment of osteoporosis. Since vitamin K<SUB>2</SUB> agents are known to cause rebound of blood coagulation capacity lowered by an anticoagulant warfarin, a great caution is necessary for the concomitant use of these agents.<BR>Objective and Design : A drug utilization survey to examine the use of warfarin and drugs for osteoporosis.<BR>Methods : Fukui Medical School Database was surveyed to identify patients who used warfarin and/or drugs for osteoporosis during the period between January 1, 1988 and July 31, 1995. Patients with a diagnosis osteoporosis made between December 1, 1983 and July 31, 1995, were also identified and their prescription data were extracted to examine the combined use of warfarin and drugs for osteoporosis. In addition, 53 outpatients with cardiovascular diseases were interviewed to know the treatments and medications given by other clinics.<BR>Results : Concomitant drug therapy for osteoporosis was given to 6.9% (56/813) of warfarin users. The proportion of concomitant use was 15% (36/234) in women, much higher than 3.5% (20/579) in men. More than 10% of the interviewed patients were receiving some treatments in other orthopedic clinics for osteoporosis or other diseases but few patients were aware of their medication.<BR>Conclusion : Old female users of warfarin, especially those having osteoporosis concomitantly, are likely to berome a high risk group for the possible interaction between warfarin and the vitamin K<SUB>2</SUB> agent. Useful information on the safety associated with the interaction between these two drugs should be given to this group of patients as well as to the prescribers and dispensers.