The Institutional Review Board (IRB) examines the propriety of continuing clinical trials based on adverse event reports. However, since such a large number of adverse events are reported, both in Japan and other countries, it is a tremendous amount of work for a member of IRB to examine all the reports provided and it takes much time. In order to help the IRB be as efficient as possible in its activities, we conducted an investigation into the management of adverse event information at the University Hospital, Ryukyu University, between April 2002 and March 2003. The number of adverse events reported was 829 and among them, new, previously unknown adverse events accounted for 30.9 percent, and those from outside Japan for 96.6 percent. This indicates that examination could be more efficient and quicker if preference were given to such new adverse events from outside Japan. Thus, in order to assist the IRB, pharmacists should prepare a table of adverse events, in which they are categorized as known or unknown and also according to source, depending on whether they occurred in Japan or overseas.
It is important for students to acquire the skills of pharmaceutical care with respect to patients. However, clinical pharmacy education in Japan is still not fully developed and teachers at faculties of pharmacy generally teach students by means of lectures, which is too passive for students. Since such a lecture-based system will not help them to acquire pharmaceutical care skills, there should also be training that simulates the provision of pharmaceutical care in the clinical situation. To address this issue, the authors tested problem-based learning (PBL) on students, with the objective of developing problem solving skills and student independence. In the PBL, students gained an understanding of the principles of pharmacotherapy and drew up hypothetical schemes for pharmaceutical care, worked out the problems and discussed them together in small groups. They also practiced role-playing, which was intended to help them learn communication skills. Afterwards, the authors conducted a questionnaire survey to evaluate the student's impressions of the PBL and they evaluated it highly, particularly with regard to learning communication and problem-solving skills. These results suggest that it would be useful to introduce PBL in clinical pharmacy education in Japan.
We developed a support system for pharmaceutical counseling services using a handheld computer loaded with HS-WIN. HS-WIN is standard software for pharmaceutical counseling services that is compatible with Windows X-P, 2000 and 98. Our support system is linked to the pharmacy network system of Oita University Hospital. It enables various kinds of information to be retrieved from the pharmacy network system and shown on the display of a handheld computer. This includes drug information, names, sex, birth dates, heights and weights of patients as well as clinical department and ward-related information. The handheld computers are the VAIO PCG-U 1 and PCG-U 3 (SONY, Inc.) and they are used at the bedside. To evaluate the effectiveness of our system, we measured the time required for the management of medication histories and patient counseling records for three wards. The system was able to reduce the time required per patient by an average of 34 minutes.
The bioavailability of digoxin is known to differ between tablets and powders. To evaluate this difference in clinical practice, serum concentrations were compared between inpatients who received tablets (tablet group) and those who received a powder (powder group). For the powder, the quantity packaged by an automatic packaging machine and that on removal from the package were measured. The C/D (concentration/dose/body weight) in the powder group was significantly less than that in the tablet group when classified according to Ccr (creatinine clearance) and age. The difference in C/D increased with age, and, as compared with the tablet group, there was a 42.2 % greater decrease in C/D in the powder group for those over 80 years old. After removal from the package, the quantity of powder was about 6.1% less than it than that packaged by the automatic packaging machine. In a study using volunteers that was also performed, the powder losses stemming from packaging were 7.3% and 18.0% in young people and the elderly, respectively. These results suggest that the difference in C/D between tablets and the powder stemmed not only from the difference in their bioavailabilities but also from losses arising during preparation and at the time of taking the powder.
In the present study, the authors examined the change in thiamine content of a TPN fluid under clinical conditions, obtained Integrated Dose in Period (IDP) values and compared this data with IDP values calculated on the basis of stability data in the literature. We also determined the bisulfite ion concentration that affected the stability of thiamine in the TPN fluid. Our results showed that, 62.5 % and 59.5 % of the thiamine in the TPN fluid remained 24 hours after its preparation under light and dark conditions, respectively. The bisulfite ion concentration decreased from 0.279 mg/mL to 0.177 mg/mL under light and from 0.284 mg/mL to 0.227 mg/mL under dark conditions. While the IDP values that we obtained were less than those calculated on the basis of the literature, they were still over the daily thiamine requirement (1.3 mg), even after 48 hours. In conclusion, the authors demonstrated that the thiamine content of a TPN fluid could be maintained at an adequate level following preparation under the conditions of the daily clinical setting, and that one can rely on stability data from the literature for the purpose of estimating IDPs for vitamins.
We conduct a three-week practical hospital training course for fourth-year undergraduate students twice a year (during the first and the second semesters) at Okayama University Medical School. In this course, students receive one day of training in the provision of drug information. We now describe the training on providing drug information and report on how it was evaluated by students. The training program consists of the following : 1.Explanation of the collection, documentation and provision of drug information, 2.Study of the collection of drug information from prepared examples, 3.Report preparation, 4.Role-playing in providing drug information, 5.Pharmacist's comments and further explanation. The examples used in the first semester consist of actual inquires that our pharmacy received, and for the second semester we developed hypothetical examples that included many technical terms used in the clinical setting, and included guidelines for each example. At the end of the practical hospital training courses for the first and second semesters, we conducted a questionnaire survey concerning the understanding of 68 technical terms connected with the provision of drug information, and compared the results between the two semesters. The results indicated that the second semester training on drug information provision was more effective than that in the first, suggesting that it is important to teach guidelines and conduct periodic evaluation.
With some drugs, the risk of increased intraocular pressure is stated in the package insert as a contraindication for patients with glaucoma. However, these drugs have often been prescribed in glaucoma patients. In the present study, we investigated the drugs that had been prescribed to glaucoma patients in our hospital as well as the use of such contraindicated drugs to see if they were being used rationally or not. In 53 patients hospitalized for glaucoma surgery in the ophthalmologic ward of the University of Tokyo Hospital, 38 patients (70%) had used drugs other than eye drops. Seven of the 38 patients had used drugs described in the package inserts as having contraindications for glaucoma patients, absolute contraindications in the case of 5 patients and relative contraindications in the case of 3 patients, with one patient having used drugs in both categories. The drugs with absolute contraindications were withdrawn in two patients, and continued in the other three patients based on the doctor's judgment that they had no effect on intraocular pressure. In addition, when we asked pharmaceutical manufacturers if there had been any case reports involving adverse effects for 59 drugs contraindicated for glaucoma in their package inserts, we discovered that for 16 of these drugs, there were no such case reports or other clinical evidence of adverse effects. From our investigation, we found that even in cases when increases in intraocular pressure may be prevented through ophthalmologic treatment, certain drugs are contraindicated for use in glaucoma patients in their package inserts. Thus there should be information in package inserts concerning the possibility of using such drugs together with ophthalmologic treatment so that they may be used in a more rational manner for glaucoma patients.
We investigated a highly effective method for collecting a sufficient quantity of autologous peripheral stem cells from patients with multiple myeloma in a single attempt. Eight patients (5 males and 3 females, mean age : 56.5 years) underwent remission-induction chemotherapy (built around a VAD regimen), followed by mobilization chemotherapy using cyclophosphamide (CPA 2 g/m2 given for 2 days, 7 patients) or etoposide (VP-16, 500 mg/m2 for 3 days, one patient). When the leukocyte count dropped below 1, 000/μL, a granulocyte colony stimulating factor, lenograstim (7.1 ±2.9μg/kg/day), was administered for around 7 days. When the leukocyte count exceeded 104/μL, stem cells were collected by processing the blood in a fluid having a volume of three times that of circulating blood and using a COBE Spectra, a blood component separating device. The required number of hematopoietic stem cells (CD 34+ cells, over 2.0 × 106/kg) was obtained from 6 patients in a single operation (within 4 hours). From 5 of them, a sufficient quantity was obtained for tandem grafting. Through adequate drug monitoring from the standpoint of a pharmacist, no severe adverse effects that would have necessitated interrupting the cell collecting procedure occurred.