Many medical accidents concerning errors in the administration of injections have been reported in recent years but many of them could be prevented through the active involvement of pharmacists in this respect. At the Department of Pharmacy of the Municipal Ikeda Hospital, a ward pharmacy was established in April 2000 and the dispensing of injections, including the mixing of injections, was commenced. In October, 2001, an injection distribution surveillance system was also established. Under the system, injections are distributed to the patients' bedsides, information provided on the drugs in them and monitoring performed.
We conducted a survey of the dispensing of injections and the surveillance system. The mixed injection preparations targeted by the survey were drip infusions for administration between 10 : 00 and 22 : 00 whose prescriptions were received by the Department of Pharmacy by 17 : 00 on the day before use, and injection preparations were mixed 4 times a day.The dispensing of injections was divided into 5 tasks : receipt of dispensing requests, preparation of labels, measuring of quantities, mixing of preparations, and preparation of infusion sets and each task was investigated for dispensing errors.Warnings were issued under the distribution surveillance system when pharmacists misidentified patients in distributing injections to the patient's bedside and the situation was investigated.
The rate of pharmacist errors in mixing injection preparations was 2.23 % in a 4-month period and though 0.04% of the preparations in error were sent to wards, they were not administered to patients. Out of the 7, 690 instances in which injections were distributed to the patient's bedside by pharmacists in the 4-month period, in 3 instances (0.04%) pharmacists were warned about misidentifying patients. All of errors were human errors, but did not lead to errors in administration. This study suggests that risk of errors made with injections could be avoided by the close involvement of pharmacists in the work of administering injections. Greater use of codes was suggested for preventing human errors in future, since codes were printed on the injection in only 14.5 % of the injections distributed during our survey. Besides the increased use of such codes, the development of an injection dispensing surveillance system using them is also necessary.

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The objectives of this study were to evaluate the risk of the accumulation of midazolam and its active metabolites in critically ill patients in an intensive care unit (ICU) being treated by continuous hemodiafiltration (CHDF) using a polymethyl methacrylate (PMMA) and/or a polysulfone (PS) membrane and the influence of CHDF on the pharmacokinetics of midazolam in these patients. The serum and ultrafiltration liquid concentrations of midazolam and its active metabolites were measured by high-performance liquid chromatography to study the pharmacokinetics of midazolam and its active metabolites in seven patients with renal failure who were being treated by CHDF using a PMMA and/or a PS membrane. There was no progressive accumulation of midazolam or 1-hydroxymidazolam, though high levels of 1-hydroxymidazolam glucuronide were noted. The extraction rates for these 3 substances by CHDF using a PMMA and a PS membrane were 1.3%, 3.0% and 13.4%, and 5.0%, 4.8 % and 74.4%, respectively. A positive correlation was observed between the 1-hydroxymidazolam glucuronide concentration and serum creatinine concentration for CHDF using the PMMA membrane (r²=0.8223), while there was no correlation between these concentrations when the PS membrane was used (r²=0.0361). These results show that CHDF using a PMMA membrane did not affect the elimination of 1-hydroxymidazolam glucuronide but it was affected when the PS membrane was used. The risk of accumulation of 1-hydroxymidazolam glucuronide and the need for prolonged sedation should be therefore be taken into account in drug dose adjustment for patients undergoing CHDF.

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The numbers of adverse event reports submitted by clinical trial sponsors have been increasing. Since the reporting items were unified and adverse event reporting by electronic media was started, reviews by Institutional Review Board (IRB) have speeded up and it has become easier to understand the situation of adverse event reporting. In the present study we expressed the quality of adverse event reports in terms of objective numerical values. We report on this in the following and discuss a method of systematically evaluating all adverse event information.
The Visual Analogue Scale (VAS) was used to evaluate the results of a survey of doctors (Drs) and clinical research coordinators and clinical pharmacists (CRCs). Both the Drs and CRCs regarded unexpected serious adverse event information as the most important. However, though Drs also placed importance on the possibility of a causal relationship with the drug and information concerning the outcome, CRCs were not really interested in anything other than unexpected serious adverse event information. We also determined a numerical distribution for the adverse events using a numerical conversion table for adverse events that we had created ourselves and compared their normal distributions determined on the basis of keywords relating to “Predictability” or “Seriousness”.
Our numerical distributions enabled the quality of the adverse event information to be systematically evaluated and the ranking of adverse events through its use should speed up reviews by the IRB.

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The major requirement for the hospital pharmacist is the practice of good pharmaceutical care. In this study, we examined the content of such pharmaceutical care and whether the average number of drugs, drug costs and the incidence of adverse drug events was reduced by the presence of the pharmacist in the neurology ward of Nagoya Daini Red Cross Hospital. We also considered ways of improving the function of clinical pharmacists in the future.
The number of the clinical pharmacy practices for the month of September 2000 was 762 broken down into dispensing of drugs, consultation with patients and other clinical pharmacy practices, with 198, 338 and 226 practices each, respectively. The greatest proportion of other clinical pharmacy practices involved supplying drug information, with advice on prescription changes and amending prescriptions coming next. The number of the clinical pharmacy practices increased from 762 in 2000 to 893 in 2003, with practices covering a broad range of functions, all needing specialist pharmaceutical knowledge. Over this period, the average number of drugs in prescriptions, drug costs and incidence of adverse drug events decreased, which resulted from pharmacists ensuring that drugs were used properly by amending prescriptions.
A major goal of clinical pharmacists is to ensure that drugs are used properly and this can be achieved through their active involvement in all aspects of pharmaceutical care as an active member of the health care team. Their role should not be limited to instructing patients on how to take drugs.

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Using high performance liquid chromatography (HPLC), the author determined the content of nicardipine degradation product (L-1) in brand-name and generic-name nicardipine injection products. The mobile phase consisted of 0.25 % KH₂PO₄ (pH 6.5) -CH₃OH (25 : 75, v/v) and the detection wavelength was set at 254 nmUV. A separate peak for L-1 was identified by using reference standard compounds. Several products of nicardipine injection on the Japanese market were analysed and the L-1 contents varied among them. Through this study, we found that there were differences in quality between the brand-name and generic nicardipine injection products, and that there were also differences in quality among the individual generic products.

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Communication skills are an essential requirement for pharmacists if they are to function competently as medical professionals. Training using simulated patients has recently been introduced in medical education and we considered that the use of simulated patients would help pharmacy students to acquire the communication skills necessary for patient consultations. To do this, we instructed volunteer patients on how to act as simulated patients and started using them as part of the training in consultations for third-year students at Kobe Pharmaceutical University. The results of a survey conducted at the end of the training indicated that students recognized the high educational value of the simulated patients due to the sense of realism they brought into the training and the tension they experienced in interacting with them, saying that this increased their interest in the work of the pharmacist and stimulated their desire to learn. The use of simulated patients was effective in enhancing the communication skills because they had to focus on their attitudes and responses.

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Though the importance of pharmaceutical information in university pharmacist education has been widely recognized in recent years very few such curriculums have been initiated in continuing education courses for graduate pharmacists. A course in the evaluation and management of pharmaceutical information for clinical pharmacy graduate students was therefore started in 2000 at the Graduate School of Kobe Pharmaceutical University as a continuing education program for pharmacists in hospitals and pharmacies. In the course, students selected two pharmaceutical care-related themes and made presentations on them to the rest of their class using MS Power Point. The contents of the presentations were discussed afterwards in small groups. In order to evaluate the educational effect of this new form of study, a questionnaire survey was conducted from 2000 to 2001. Dividing attendees into pharmacists and full-time department graduate students as appropriate, and conducting tutorials for small groups, efficient training in problem solution capability was given. In addition, the creation of an educational website enabled EBM information to be collected quickly and accurately and this aided the training of the students in evaluating information. The active discussion of presentations in small groups enhanced the ability of students to generate quality information and the differences between before and after taking the course were shown statistically by the results of the questionnaire.

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Orally disintegrating tablets are generally highly hygroscopic and less resistant to physical damage than other types of tablets. In consideration of this, we examined orally disintegrating brotizolam tablets (D tablets), for damage sustained in dispensing using an automatic packaging machine as well as for changes in form and color after being packaged in the cassette. There was no damage to or changes in the form or color of the D tablets due to the automatic packaging machine, suggesting that it is strong enough for daily dispensing using such machines.
We also conducted a questionnaire survey of inpatients taking D tablets to find out how useful they were. Only 26% of the 62 inpatients surveyed took the D tablet without water because many of them were taking other drugs simultaneously. We therefore assumed that the D tablet would be useful when taken as a single drug in elderly and other patients in whom there are restrictions on water intake. There was no difference in numbers of patients who wished to continue taking the D tablet and the ordinary brotizolam tablet.
In conclusion, the D tablet appears to be as resistant as other types of tablets to unit dose packaging, and it should be selected in favour of the ordinary tablet in accordance with the preference and condition of each patient. With a view to improving QOL and patient compliance, pharmacists should provide the necessary information on such tablets.

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We carried out a medication questionnaire survey in the Pediatric Surgery Ward of our hospital to investigate how caregivers were giving powdered drugs to their children and drug history questionnaire survey to investigate adverse reactions and allergies. The subjects were 269 children aged 0-10 years. We found that 72% of the 42 children aged less than 1 year were given the powder dissolved in drinking water. As for the 51 children aged 1 year, 33 % were given the powder dissolved in water and 19 % took the powder mixed with yogurt or ice cream. For most of the 144 children aged 2-6 years, the powder was given alone (44%) or dissolved in water (42%), whereas 91 % of the 32 children aged 7 years or over took the powder alone. However, though such a large number of caregivers dissolved drug powders in drinking water before giving them to their children, only 37 % of them knew that some powdered drug preparations should not be dissolved in water. Thirty-six children were unwilling to take powders, but compliance improved in 14 of them (39%) through advice given in this respect. The drug history questionnaire showed that 3 of 4 children with a milk allergy had been given a prescription for MEIAKUTO^® granules. We requested their physicians to change the prescription to avoid any risks. It also revealed that 20 children had brought drugs into hospital with them, some of them antibiotics, which enabled the double administration of antibiotics to be avoided. The results of our surveys suggest that it is important to advise caregivers regarding the correct method of administration and that checks should be made for histories of side effects and allergies as well as medicines brought into hospital in order to avoid adverse drug reactions.

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The equivalencies of generic drugs are assessed by biological equivalency tests. These tests are conducted on healthy subjects by the crossover method in comparison with the original product, which makes them a useful method for comparing bioequivalencies among generics. However, since a large variation in the results is sometimes observed, we decided to determine what causes this.
We requested 28 companies to provide biological equivalency test results for pravastatin sodium tablet (23 products) and compared pharmacokinetic parameters among them. There was a large variation in pharmacokinetic parameters, especially in maximum serum drug concentration, area under the serum concentration to time curve and elimination half-life, though there were no differences between the original product and generic product in each test.
On comparing individual parameters from two tests that were carried out according to nearly the same protocol, there was a marked difference in the distribution of data among subjects, indicating that this was a factor causing parameter differences between tests. Thus, when pharmacists are thinking of using a generic drug, it is important for them to notonly consider average parameter values but also the process by which these values have been obtained.

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