In the treatment of insomnia, assessment of the state of sleep is important in finding suitable hypnotics for individual patients. Though physicians select hypnotics according to general condition and concomitant medicines, patients are not always satisfied with their quality of sleep. We conducted interviews to assess sleeping conditions and satisfaction with hypnotics in 205 patients who included those treated with zolpidem (n=66, 32.2%) and brotizolam (n=60, 29.3%). No significant differences were observed in patient backgrounds between those taking zolpidem and brotizolam. Both medicines showed clinical efficacy matching their pharmacological characteristics. The onset of sleep tended to be quicker for zolpidem than for brotizolam. The number of patients who awoke before 5 o'clock was greater for zolpidem. Alternative hypnotics should be considered for patients who are not satisfied with the one they have been given due to these characteristics of the prescribed drugs..
A micro-tapered needle (TN-3305) with a 33 gauge (G) tip and 28G base has recently been developed. However, since there was a possibility of the reduction in needle diameter leading to reduced needle strength and an increase in injection resistance making the discharge time for insulin longer, we investigated the usefulness of this new type of needle in a basic study. A 33G injection needle (test product) and a commercially available pen-type special insulin syringe needle (pen-type syringe needle) for use in pre-filled insulin products were used as the controls. The study involved a strength test, a perforation resistance test using silicon rubber sheets and porcine skin, an injection resistance test and measurement of the insulin liquid lag time and size of the perforation scar. The results showed that the TN-3305 needle had almost the same strength as the 31G needle, and the injection resistance value and insulin liquid lag time were the same or less than those for the 30 G needle, and the perforation resistance value and size of the perforation scar were smaller than those for all of the commercially available pen-type syringe needles used. The tapered structure of the TN-3305 needle enabled it to overcome the problems associated with narrow needle diameters and to achieve the lowest perforation resistance in our basic study.
Interferon-ribavirin combination therapy is the mainstay treatment for chronic hepatitis C today. In view of its very common use, we investigated the adverse drug reactions through a retrospective review of medical records of chronic hepatitis C patients who underwent such therapy. We also determined their current condition by investigating hemoglobin levels, white blood cell counts and platelet counts. Subjects were 20 chronic hepatitis C patients (7 females and 13 males, mean age 53.6 years) who were hospitalized in the Department of Gastroenterology of Kasugai Municipal Hospital to undergo interferon-ribavirin combination therapy. Ten patients were classified as HCV serotype 1, and 10 as HCV serotype 2. Four patients discontinued the therapy. Bloodtests showed that the rate at which hemoglobin levels, white blood cell counts and platelet counts decreased tended to belower than before treatment. No notable adverse drug reactions were observed in this study, those that did occur were similar to those seen with interferon monotherapy and with the exception of muscle pain, there were no significant differences. However, many individualdifferences were seen in terms of severity, time of onset and duration of symptoms. This confirmed the need for guidanceto be geared towards individual patients. Based on the results of our investigation, we revised our brochure on interferonribavirin combination therapy to give a fuller explanation of the adverse reactions. We feel that it is very important for patients to have a good understanding of the possible adverse reactions beforehand and to make an adequate response whenthey occur during therapy.
In recent years, computerized prescription order entry systems have played an increasingly important role in medical risk management as such systems have become more sophisticated. Though prescription order entry systems enable us to access huge amounts of information in drug information databases on drug interactions, adverse reactions and so forth, it is very difficult to manage such large amounts of information. Prescription order entry systems have a prescription checking function but the master maintenance must be done properly for it to work well. With this in mind, we developed an improved system using a commercially available program, PC-ORDERING 2000 (NEC Corp.), to make it easier to use the master maintenance screen of the order entry system. In order to investigate the resulting improvements we did the following : 1) measured the improvement in input efficiency, 2) evaluated the improvement in reference functions, 3) evaluated the improvement in file output functions and 4) made a comparison with the existing system. As a result, we found that the required maintenance time with the improved system was reduced to 66% and considered this to be very important to risk management since the prescription checking function in the order entry system had been enhanced.
We felt that pharmacists should participate more actively in the evaluation of efficacy and safety in clinical trials. To improve the capability of pharmacists in this respect, we evaluated the support we gave to the investigators of the Japan EPA Lipid Intervention Study (JELIS), a long-term, large-scale clinical trial conducted at the Department of Pharmacy of our hospital. To identify the problems in our support, we investigated the number of days required to complete the Case Report Form (CRF) and the reliability of the data collected, by considering the adequacy of the items observed and the clinical inspection terms. Our findings indicated that it was feasible for pharmacists to handle the coordination of JELIS in addition to their everyday workload and we also noted an improvement in the clinical inspection rate, from 76.6% to 100% for JELIS I and from 97.5% to 100% for JELIS II. Moreover, we found the number of days required to complete the CRF was reduced from 109.8 days to 20.3 days for JELIS I and from 79.5 days to 21.0 days for JELIS II. These results show that the pharmacists in our hospital helped to maintain the reliability of clinical data.
Recently, carboplatin/paclitaxel (TJ) therapy has been recommended as a standard treatment for ovarian cancer. However, a clinical pathway for the safe use of these novel anticancer agents had not been established. We prepared a clinical pathway based on evidence-based medicine (EBM) using information from clinical records and the literature. We analyzed the clinical records of 33 patients who had undergone TJ therapy for ovarian cancer and were hospitalized in the gynecology ward of the Showa University Hospital. Grade 3 or higher toxicities of leucopenia, neutropenia, and thrombocytopenia occurred in 52%, 55%, and 6% of these patients, respectively. There were also high incidences of nausea, vomiting, arthralgia, and peripheral neuropathy. Check lists for these toxicities were therefore included in the clinical pathway. The National Cancer Institute Common Toxicity Criteria (NCI-CTC) were used for evaluation of the toxicities. Medicines andmedication criteria for supportive treatment were described based on the guidelines of the American Society of Clinical Oncology (ASCO) or the U.S. Infection Society. Doctors and co-medicals, nurses and pharmacists participated in discussionsaimed at making the clinical pathway safe, easy to use and readily available to wards. Firmly based on EBM and includingguidelines for conducting chemotherapy safely, the clinical pathway that we prepared should be helpful in risk management.
For the efficient management of stock medicines at our hospital, we developed a computer system in which expiration dates are recorded and used data produced by it to reconsider our selection of stock medicines. We report on an evaluation of this system. The monitoring of expiration warning lists automatically generated by the computer system by our pharmacists prevented stock medicines from expiring before use. Further, a reconsideration of our stock medicines based on usage data in each ward produced a 25.0% decrease in the total number of medicines stocked and a 24.7% decrease in the overall cost of stock medicines. Thus, the computer management system enhanced safety for our stock medicines and a reconsideration of medicines stocked based on usage data enabled us to reduce ward costs.
A retrospective evaluation of practical training in pharmaceutical health care andsciences undergone by third-year undergraduate students at Kyoto Pharmaceutical University was conducted through an anonymous questionnaire survey of students from 2000 to 2002. During these three years, the students had been very conscious of the necessity of the practical training for them. Therefore, the expectations of students of the practical training increased year by year and student's satisfaction with the training was greater than their expectations in every year. However, the students did express various opinions and desires regarding the practical training program and system. Based on the results of the survey, we considered ideas for improvement and solutions to problems. Modifications proposed included taking more care in selecting the practical training schedule, shortening of daily practical training sessions, concentration on training in communication skills, and changing from a passive to an active training schedule, including small group discussion, presentations, and role-plays. In 2003, these modifications were applied in the practical training in pharmaceuticalhealth care and sciences at Kyoto Pharmaceutical University. In conclusion, our survey was useful in that it enabled us to understand the needsof our students better and points of the practical training requiring improvement. We also consider that the survey was important because it enabled us to evaluate the practical training program for ourselves. We now hope to make the present practical training more effective for learning professional ethics required of pharmacists as a member of the clinical team.
In Japan, the daily dose of donepezil hydrochloride (DPZ) is fixed at 3mg for 1 or 2 weeks and is to be increased to 5mg thereafter. Although the initial dose of 3mg/day has proved useful for avoiding gastrointestinal and other adverse effects, it has not proved efficacious. However, as reported to the “Internet-Based System for Sharing Pharmaceutical Case Reports” (Ohtani H., et al., YAKUGAKU ZASSHI 122 : 185-192, 2002), DPZ has also been used under irregular dosage regimens. The aim of this study was to investigate the actual usage of DPZ in clinical practice by means of an e-mail questionnaire sent to pharmacists working in medical facilities. Replies were received from a total of 194 pharmacists (17.5%). Seventyfour (38.1%) respondents said that they had seen prescriptions for DPZ with irregular dosage regimens, most of which involved administering DPZ at a dose of 3mg/day for more than a week or reducing the dose of DPZ from 5 mg/day to 3 mg/day. The primary purpose of these irregular dosage regimens was to avoid adverse reactions. Although clinical trials have failed to prove efficacy for DPZ at a dose of 3mg/day, the results of our questionnaire imply that DPZ may actually be effective in some patients at this dose. Since irregular dosage regimens are not to be recommended, further clinical studies are needed to analyze the therapeutic effects of DPZ from the pharmacokinetic and pharmacodynamic viewpoints in order to clarify the factors of inter-patient variations in efficacy.