A year-long prospective study was conducted to elucidate the effects of probucol, an anti-oxidative hypolipidemic agent, on the progression of diabetic nephropathy. A total of 152 diabetic outpatients with an urinary albumin level of 200mg/g·Cr or more, and who routinely visited our hospital were divided into two groups of 75 patients treated with probucol (500mg/day) and 77 non-treated patients. All patients were observed for 12 months. The results reveled no significant difference in the blood pressure or HbA1clevel between the two groups. However, the serum lipid levels in the probucol-treated group decreased by 16 to 18% (p< 0.01) for total cholesterol, 19 to 28% for neutral fat, and 17 to 21% (p<0.01) for HDL-cholesterol, while they did not significantly change in the non-treated group. As for the renal function, probucol suppressed the progression of nephropathy in a patients group with a moderate to severe serum creatinine and urinary albumin level and another patient group with a mild to moderate urinary protein level at severity level of from ± to 2 +. Kidney dialysis was required in 2 probucol-treated patients and 9 nontreated patients, where the rate of dialysis shift after the serum creatinine concentration exceeded 2.0mg/dL was 15% in the probucol-treated group and 58% in the non-treated group. From the present results, it was suggested that probucol suppresses the progression of diabetic nephropathy, thereby extending the period until dialysis is required.
In Japan, traditional herbal medicines (kampo medicines) have been widely used for various diseases as relatively safer drugs than Western medicines. However, serious adverse-events such as interstitial pneumonia (IP) and liver dysfunction (LD) have recently been reported. In this study, IP and LD associated with Kampo medicines were reviewed pharmacoepidemiologically to establish an effective monitoring protocol and appropriate treatment schedules while also elucidating the possible ingredients for IP and LD. Medline, JICST and J-Medicine databases were searched for IP and LD induced by Kampo medicines published in 1984-2000. Thirty-five cases of IP including 8 mortal cases and 28 cases of LD have been reported. As initial symptoms, 60-80% of IP patients developed dyspnea, fever and cough. On the other hand, the initial symptoms for LD patients were not characterized. Stopping the medications improved the symptoms in 29% of IP and 54% of LD patients. A total of 72 % of IP and 7 % of LD patients required corticosteroid treatment. Scutellariae radix was contained in Kampo medicines for 94% of IP patients and 89% of LD patients. A challenge test was positive in 9 cases of IP and 10 cases of LD. Scutellariae radix was contained in all positive Kampo medicines. Our review suggested that Scutellariae radix was a possible ingredient responsible for IP and LD. Monitoring the initial symptoms and immediately stopping medications were important steps for avoiding serious adverse-events associated with Kampo medicines.
The Ministry of Health and Welfare (the present, Ministry of Health, Labour and Welfare) has begun to report the recall information of medical supplies (in short, recall information) on the home page of the pharmaceutical information provision by the Organization for Pharmaceutical Safety and Research since April 1 st, 2001. However, all recall information on the home page appears the day after the official publication. In case of medical devices in comparison to pharmaceuticals, it takes a longer time to be reported on the home page. However, such recall information is valuable, because it is the only information source, which medical institutions can obtain up-to-date information spontaneously. At Uwajima City Hospital, from May 2001, the pharmacists have participated in a safety management program regarding new medical devices or medical materials. In order to keep all medical materials safe, pharmacists check the recall information regularly and provide them to the clinical site for risk management. Not only the medical institutions but also the dealers have begun to make practical use of such recall information. However, no system for using such information has yet been established among them. According to the regulations of recall information, a contact system from the maker to the dealer has been established. However, the first information of medical devices is always obtained through the home page. The way to obtain the information has been changing. Needless to say, the “Internet” is nowadays the main media for the communications all over the world. Accurate information must be speedy and reliable. The rational use of such information on the Internet is therefore urgently needed.
Selenium is a component of glutathione peroxidase (GPx), which metabolizes oxygen radicals. Generally, selenium is obtained from such foods as grains and fish. Therefore, for patients with severe motor and intellectual disabilities (SMID) who cannot orally consume meals, a selenium deficiency remains a problem. To overcome this problem, selenium oral solution was administered to SMID patients under long-term total parenteral nutrition, and the usefulness of selenium oral solution was evaluated using the serum selenium concentration and GPx activity as indices. Before selenium oral solution administration, the serum selenium concentration of SMID patients was 3.0 ± 0.7, μg/dL, which is an extremely the low value compared with 11.2 ± 1.2, μg/dL which is the normal value for a healthy adult. Moreover, the GPx activity of 48.5 ± 12.3 n mol/min/mL was also extremely low in comparison to a healthy adult' s value of 112.6 ± 5.6 n mol/min/mL. When a selenium oral solution (6, μg/kg) was administered to SMID patients for two weeks once per day, the serum selenium concentration and the GPx activity increased, and there was no difference from a normal healthy adult' s value. Although the selenium oral solution thereafter decreased to 1.5μg/kg once per day, the serum selenium concentration and the GPx activity were mostly maintained in the normal region. Moreover, a significant positive correlation was observed between the serum selenium concentration and the GPx activity. (p< 0.001) These results suggested that the administration of oral selenium solution to patients with selenium deficiency diseases, such as SMID, and patients under long-term total parenteral nutrition, thus improved the serum selenium concentration and GPx activity.
It is important that laboratory data to be constantly checked according to described package inserts during usage of medicines. However, many hepatic and renal disorders were reported to have strong adverse reactions for prescription drugs. We investigated the necessity of hepatic and renal function checks in package inserts for 3300 prescription drugs. As a result, the number of drugs which recommended checks on hepatic and renal functions were 240 (7.3%) and 209 (6.3%) respectively. The described expression or place regarding checks of hepatic and renal functions on package inserts were various types of unclear information to doctors and pharmacists. We thus found that the present style of package inserts unapprehensive to the necessity of hepatic and neral function checks. So, in our hospital, we decided to provide a list of drugs that required hepatic and renal function checks during administration of drugs. These findings suggest that the need of hepatic and renal functions monitoring during the administration of drugs by the establishment of a new Clinical Checks item in the package inserts is therefore necessary.
Under the current concept, asthma is recognized as a chronic inflammatory disorder of the airways and inhaled corticosteroids are the most effective for the treatment of asthma. Dry powder steroids were first introduced to Japan in1998. This study evaluates the dry powder inhaler (DPI) from the perspective of ease of handling and the time required for instruction compared with the metered dose inhaler (MDI). Moreover, the relationship between peak inspiratory flow (PIF) and the number of times required for the complete inhalation of DPI were investigated. One hundred and six adult asthmatic outpatients were entered into this study, including 54 who received DPI with the Diskhaler® and 52 who received MDI with the Volmaticr® spacer. A checklist was prepared for the evaluation of device handling acquirement. More patients in the DPI group performed inhalation correctly than patients in the MDI group (83 vs. 34%). The time required for instruction in the DPI group was shorter than the MDI group (11.37±4.35 vs. 16.14± 3.82 minutes). These results showed that DPI was an easier-to-use device compared with MDI. However, patients with low PIF (< 50L/m) frequently failed to inhale dry powder completely. In addition, PIF and the number of times required for the complete inhalation of DPI were negatively correlated (r= 0.870, p< 0.01). This study showed that sufficient instruction and appropriate selection of the inhaler played an important for asthmatic patients requiring inhaled corticosteroids.
Effective communication is central to patient-centered care in the successful practice of pharmacy. As well as communication skills, a pharmacist should acquire an effective presentation technique to establish interpersonal communication at a more than purely on a verbal level. Most undergraduates of Kobe Pharmaceutical University undergo practical training in hospitals or community pharmacies. It is essential for students to acquire communication skills in order to derive the full benefit from the practical training. We introduced a presentation and communication program at the pre-practical training stage. In the presentation component, students were asked to make a presentation on eight different aspects of a certain drug; in the communication component, students took part in a session where they learned and discussed interview skills, non-verbal communication, open-ended questioning and effective communication. Questionnaires answered by the undergraduates suggested that this training course had made a strong impression on them and had served as a useful guide to acquiring the presentation and communication skills essential in pharmaceutical care.
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), is widely used in the treatment of patients with depression. It is known that fluvoxamine inhibits the activity of human cytochrome P450 enzymes (CYP) responsible for the oxidative metabolism of many drugs. Inhibition of CYP results in a number of clinically important pharmacokinetic drug interactions. Therefore, the interaction between warfarin and fluvoxamine was evaluated. The patients treated with fluvoxamine were selected from the prescription database file made for the prescriptions order entry system, which contains all the prescriptions filled for the inpatients and outpatients. There were 106 patients treated with fluvoxamine between July 2000 and June 2001. Of 106 patients, 20 used warfarin concomitantly during the study period. Increased INR/Dose values were observed in all patients after the initiation of fluvoxamine therapy. Subsequently, the high INR/Dose values were observed during the concomitant use of warfarin and fluvoxamine (P<0.01). It is suggested that the increase in the anticoagulant activity of warfarin occurred when fluvoxamine is used concomitantly. Therefore, frequent coagulation tests are required in patients treated with warfarin after the initiation or discontinuation of fluvoxamine therapy. In conclusion, warfarin should be used with worry when fluvoxamine is used concomitantly.
Inhaled steroids play an important role in treating patients with bronchial asthma. Especially, inhaled steroid can prevent side effect at whole body because of providing a little quantity and high concentrated steroid at locally compared with oral or injected. Recently, during the inhalation of steroids, a metered dose inhaler displaces a dry powder inhaler. Although it is convenient due to its portability, it is reported that the rate of side effects in Flutide® is higher than that observed for inhaled steroids. We surveyed the occurrence of side effects, symptoms, period of usage, experience of metered dose inhaler medicine from fifty-three patients with face-finding on the spot regarding inhaled dry powder type steroids, Flutide® and determined whether or not side effects occur and then compared the findings. The frequency of side effects was 47.1 % and the average age of this group was older than that of the non-occurrence group (P<0.05). There were no differences between the other groups. There were many side effects of the throat. 70.6% patients inhaled Flutide® as directly about inhalant number and quantity in one day. These findings indicated a need to re-examine the inhalation speed and manner of gargling and the direction of inhalation to prevent side effects.
Medical workers are continually faced with determining the appropriate usage of disinfectants in the areas of hospital nursing and home health care. The present study has been designed to provide answers to such questions as “what kind of technique is best for intra-airway and oral aspiration ?” and “what is the most effective use of disinfectants during aspiration procedures to prevent infectious diseases ?” First, the microbial contamination of suction catheters and disinfectant solutions, which have been in use for 24 hours, were investigated. The results indicated contaminations in 50% of catheters and one of the disinfectant solutions, which were presumably caused by the different aspiration techniques of nurses. Experiments were designed to improve the manual, and the results presented to nurses and pharmacists. Additional items to the manual are : (1) The necessity of removing saliva and sputum from the catheter prior to rinsing with the disinfectant solution; (2) The appropriate volume of rinse water and disinfectant solution necessary to achieve a complete de-contamination of the catheter; (3) Preventive techniques used to avoid microbial contamination of disinfectant; (4) Disinfectant soaking techniques for the catheter; (5) Advice for hospital/home health care personnel regarding the proper bedside use of a catheter and disinfectant bottle to maintain appropriate hygienic conditions. The results and subsequent improvement of the instruction manual had a pronounced effect on both the aspiration techniques of nurses, and upon the attitude of pharmacists in our hospital. The pharmacists now realize their leading role in the effective and proper usage of disinfectants.
Clinical research as well as basic research is one of the important aspects for the development of clinical pharmacy. In clinical pharmacy research, like research in medicine, it is desirable to find and investigate problems on clinical pharmacotherapy and to utilize the findings of such results in the therapy. In order to promote such clinical pharmacy research, collaboration between hospital or community pharmacies and pharmaceutical universities is very important, because the former usually does not have enough space, equipment, or pharmacists to do the research, and the latter usually does not have chance to find the problems in clinical pharmaco-therapy. In the present study, we carried out a questionnaire survey concerning clinical pharmacy research, in order to clarify the present situations and needs in hospital or community pharmacy in Hiroshima prefecture. The results indicated that many pharmacists in hospital as well as community pharmacy feel that it is necessary to do clinical pharmacy research to understand and clarify the problems they found in clinical pharmacotherapy. In addition, though many of them are either not doing or can not do clinical pharmacy research under the present situation, they are interested in collaborating with pharmaceutical universities. These results offer important information in promoting clinical pharmacy research based on the collaboration between hospital or community pharmacies and pharmaceutical universities.
The new Good Clinical Practice (GCP) guidelines, which were based on ICH-GCP, were enforced in Japan in April 1997. These guidelines recommend that pharmacists play the role of managers of investigational drugs and also as cooperators (clinical research coordinator) in the performance of clinical trials. In this study, we carried out a survey of the attitude of the new graduate pharmacists (the group of graduates in the 1998 fiscal year and a group of graduates in the 1999 fiscal year) on clinical trials. After the first questionnaire, we lectured the students on GCP and performed clinical trials, and then the second questionnaire was conducted two months later. The group of graduates in the 1999 fiscal year had more opportunities to come in contact with information on clinical trials than the group in the 1998 fiscal year. Both groups knew that new GCP guidelines had been established, but they did not understand the details. Some of them had a negative impression concerning clinical trials. The lectures improved their knowledge and impression on the practice of clinical trials. After the lecture, over 90% of them thought that pharmacists should manage investigational drugs and provide information on these drugs for the rational practice of clinical trials. Furthermore, in 60% or more of the students, an improvement in the consciousness of evaluating the safety and efficacy of investigational drugs regarding the pharmacist's role was found.
The injection auto ample dispensing equipment, combined with an ordering system, was established at the Kasugai Municipal Hospital. This equipment enabled us to give a patient one injection per prescription unit out of approximately 400 different prescriptions. In the hospital, this is now available in every ward except in the ICU. This system has been functioning favorably since its installation : it accurately produces prescriptions for injections, written instructions for injections, and labels for infusion bottles. Due to these traits, the people who work in the wards think highly of this system. A safety control system to prevent medical mishaps has been established because drug duplications and interactions with all types of medications can be checked with the injection auto ample dispensing equipment before administering injections to patients. However, we still have some problems to solve : namely, we still have to check the incompatibility and maintain the stability in mixing injection drugs.