Clinical research coordinators (CRCs) are required to have good communication skills in order to explain the informed consent process to potential volunteers.Based on the assumption that explaining informed consent should be part of advanced level training in developing the communication skills required of health care workers,role-playing exercises in the informed consent (IC) process were incorporated into the clinical trial coordinating office practical training for pharmacy students in 2006.
The role-playing exercises were greatly appreciated by trainees as they provided the opportunity to learn the importance of the attitude toward patients and effective communication,and have proved to be useful to pharmacy students.
Through such tools as audio-visual aids,we will further improve the quality of our program and also apply it in communication training for new medical personnel and other health care professionals.

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In clinical practice,the glomerular filtration rate (GFR) is often estimated from serum creatinine (Scr).However,several recent studies have shown that serum cystatin C (SCysC) is a better parameter for the diagnosis of early impaired renal function than Scr.
In this study,we measured SCysC and 24 hour creatinine clearance (CLcr) levels in 102 in-hospital patients to determine if there was a relationship between the 2 parameters,finding that 1/SCysC was significantly positively correlated with CLcr.From the results,we derived the simple formula CLcr=65.45/SCysC-3.36(r=0.79,p<0.01).
Using a formula including the one above we predicted vancomycin concentrations based on SCysC and compared them with actual vancomycin concentrations in 17 patients.Our analysis of the results showed that the formula had greater prediction accuracy for vancomycin concentrations than the Cockcroft&Gault equation which is based on Scr.
These results suggest that SCysC is a better marker of renal function for setting initial doses of vancomycin and other drugs that are renally excreted.

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Prevention of adverse effects is an important aspect of cancer chemotherapy.In this regard,nausea and vomiting induced by chemotherapy are limiting factors in patients’activities of daily living.As it has been reported that gender is a risk factor for emesis in other countries,we investigated the relationship between gender and the incidence of nausea and vomiting in Japanese outpatients receiving cancer chemotherapy.Our subjects were 70 male patients and 47 female patients receiving 6 regimens of chemotherapy at the Outpatient Oncology Unit of Kyoto University Hospital in 2005,for which the risk of acute emesis was over 90%.We studied the incidence of chemotherapy-induced emesis and evaluated its severity using the Common Terminology Criteria for Adverse Events v.3.0.Though almost all patients received dexamethasone and 5-HT3 serotonin receptor antagonists,the incidence of nausea with grade 2 or higher in female and male patients was 23.4% and 2.9%,respectively,and the incidence of vomiting in female and male patients was 25.5% and 5.7%,respectively.We examined these results by means of logistic regression analysis with adjustments for age and history prior to chemotherapy to see if there was an association between chemotherapy-induced emesis and gender.The findings indicated that woman had a higher incidence of emesis than man with adjusted odds ratios of 8.77 for nausea (95% confidence intervals 1.71-44.95)and 3.26 for vomiting (95% confidence intervals 0.90-11.77).This suggests that being female is a predictive factor of poor antiemetic control in Japanese patients and information on such predictive factors for adverse reactions should be useful to clinical pharmacists in conducting cancer chemotherapy more safely.

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Injectable medicines containing sodium carbonate produce carbon dioxide gas upon dissolution.The generated carbon dioxide causes a drop in liquid level in the drip cylinder during infusion,which may facilitate the entry of air into the bloodstream.In this study,we examined the influence of the amount of sodium carbonate in injectable medicines on the extent of lowering of the liquid level and investigated the risk of air embolism due to carbon dioxide,using seven injections and five half kit products.
Regardless of the injection-half kit combination,the injection liquid level was decreased when the injections were dissolved.The drop in the liquid level was up to 10mm.Except for cefozopram hydrochloride,the lowering of the liquid level seemed to be dependent on the amount of sodium carbonate.The liquid level was markedly lower for two port products than it was for TN or bag products,and was also lower at an infusion rate of 100mL/120min than it was at 100mL/60min.
In conclusion,besides sodium carbonate amount,infusion rate and hermeticity also seemed to be risk factors for air embolism following the dissolution of injectable medicines containing sodium carbonate.

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In preparation for the introduction of advanced problem-based learning (PBL) at higher levels of the 6-year curriculum of pharmaceutical education which began in April 2006,we conducted a PBL trial in the clinical pharmacy course for graduate students (n=16).There was 1 case of Typical Type PBL and four cases of Question Type PBL.The results of a questionnaire survey concerning the PBL lectures indicated a high level of satisfaction for many students and in the“general evaluation”of the self-assessment by students,they gave high scores to both Typical Type PBL and Question Type PBL.The data obtained were subjected to Customer Satisfaction (CS) analysis which is generally used for market surveys.When applied to the self assessment,CS analysis uncovered problems that would have been overlooked by conventional statistical analysis such as those in mean assessment values.The use of Customer Satisfaction analysis in this way enabled us to infer that the combined use of Typical Type PBL and Question Type PBL was effective in self learning by students.

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Long-term treatment with antibacterial agents is thought to be a cause of increased susceptibility to resistance.To prevent resistance in bacteria,a method of determining adequate regimens is needed and the Monte Carlo simulation (MCS) has proved useful for this purpose.In order to evaluate the inhibitory effect of the meropenem (MEPM) usage amount according to the recommended regimen based on the results of the MCS,we conducted a retrospective study using data from a database of inpatients at Iizuka hospital in 2006.We estimated the usefulness of the recommended regimen by comparing MEPM daily doses and the integrated frequency rate (IFR) of the percentage time it was above the MIC (%T>MIC) with those of the actual regimens.The results of doing this indicated that switching the actual regimens to MCS results-based regimens would have decreased the daily dose of MEPM by 43.9%.We also found that for the same dosing interval and daily dose,a regimen with a shorter infusion time achieved a higher IFR for %T>MIC values of 30% and 50%.This finding serves as a caution that just selecting a prolonged infusion time is not certain to raise the IFR of %T>MIC.Thus,the selection of appropriate dosages in consideration of the MIC of the pathogen and achieving high IFR levels will provide accurate and effective administration of MEPM

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Patients admitted for surgical procedures have often taken a variety of medicines for heart disease or hypertension in addition to those for their underlying diseases.In this study,we examined the withdrawal periods for anticoagulants and antihypertensive medicines before surgery,and investigated the effect of angiotensin II receptor (ATII) antagonists on blood pressure during surgery.
In July 2005,300 patients underwent surgical procedures in the Day-Surgery Unit and 314 in the surgical wards (excluding ophthalmology).We prepared a chart of recommended withdrawal periods before surgery,and based on it investigated the withdrawal periods for these patients.Furthermore,patients were assigned to 2 groups : Group I in which ATII antagonists were withdrawn 24 hours prior to surgery or earlier (n=10); and Group II,in which ATII antagonists were administered in the morning of the day of surgery day (n=9),and compared blood pressures between two groups.
Forty-four patients (16.7%) in the Day-Surgery Unit and 47 patients (15.0%) in the surgery wards had been taking anticoagulants,angiotensin converting enzyme inhibitors or ATII antagonists.In the case of 10 patients in the Day-Surgery Unit and 12 patients in the surgery wards,anticoagulants were not discontinued sufficiently long enough before surgery.Further,patients who had been taking ATII antagonists had lower systemic blood pressures and more frequent episodes of hypotension than those not on ATII antagonists,although these differences were not statistically significant.
In conclusion,pharmacists should provide doctors with adequate information regarding times of drug withdrawal to reduce risks while patients are under anesthesia.

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We have been promoting proper antiemetic therapy for chemotherapy induced emesis based on antiemetic treatment guidelines.In doing this,we have formulated our own antiemetic usage criteria,and classified registered regimens according to emetic risk based on ASCO,MASCC and NCCN guidelines.We investigated the compatibility situation of currently registered regimens by assigning them either to a compatible group (antiemetic agent prescriptions for acute nausea and vomiting meeting the usage criteria) or a non-compatible group (prescriptions not meeting the usage criteria).Patients who had received chemotherapy were targeted for investigation of drug management and guidance records,and a comparison of the 2 groups was made regarding acute nausea and vomiting incidence.Regimens with a high emetic risk accounted for 57.3% of the total,the compatibility rate with the acute anti-emesis usage criteria was 36.3% and a large percentage of regimens with high emetic risk were in the non-compatible group (45.9%).Common deviations from the usage criteria in the non-compatible group were multiple doses of 5HT3 receptor antagonists and insufficient dosages of adrenal corticosteroids.Further,nausea and vomiting greater than grade 2 frequently occurred in this group,and this pattern became more evident as the emetic risk increased.
We demonstrated that the improvement of antiemetic therapy based on the guidelines was effective in alleviating emetic risk and our findings indicated that there was a particular need for improvement of therapy for high emetic risk regimens.

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A very important function of a drug information room is to answer questions from medical staff swiftly and accurately.While there have been many similar questions up till now,records of such questions and the answers given to them had only been accessible to drug information room personnel.In view of this,we made a database from the question and answer records in the drug information room into a database,and constructed a system by which it could be used easily by all staff.The use of a Web-version DB for the system enables searches of questions and answers by content via an electronic medical chart network.
In a usefulness evaluation of the database after its introduction,the selection of the response“Web-version DB is useful” ranged from 64.2%-94.4% among pharmacists,nurses,and doctors.The access counter showed that the Web-version DB was used every day.As all medical staff can use the Web-version DB regardless of location or time,we consider that it is very useful with regard to ensuring the proper use of drugs and taking effective risk management measures.

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Transcatheter arterial embolization (TAE) and transcatheter arterial infusion (TAI) using cisplatin suspended in Lipiodol^® Ultra-Fluide (Cisplatin/Lipiodol) are considered to be useful tumor-targeting therapies for hepatocellular carcinoma.However,little information is available on adverse events due to injection of Cisplatin/Lipiodol because the combined use Lipiodol and Cisplatin has not been approved by the Japanese government yet.Upon investigating the frequency and time of onset of adverse events following injection of Cisplatin/Lipiodol in 16 in-patients at Mie University Hospital,the frequency of the subjective symptoms of stomachache including epigastrium ache (75.0%),nausea or vomiting (50.0%),fever (50.0%),and gastric region discomfort (37.5%) was observed to be high.Further,leucocytes and neutrophils increased 2 days after injection (p<0.001)and the onset of thrombocytopenia was much earlier than that following injection of Cisplatin alone.Severe adverse events defined as grade 3 or 4 in the Common Toxicity Criteria for Adverse Events Version 3.0 (JCOG/JSCO version,National Cancer Institute) were observed in 12 patients.These results suggest that great caution should be exercised with respect to adverse events occurring during Cisplatin/Lipiodol therapy.

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In order to ensure that drug therapy is effective,it is important for patients to understand dosage regimens correctly and take drugs properly.For the purpose of enhancing compliance,we conducted a survey of the dosage forms and dosage regimens of choice for inpatients.The survey was conducted between March 1 and April 22,2005 and responses were obtained from 449 patients,aged from 3 to 92 years.Regarding number of doses,patients between 30 and 59 preferred a lower number of doses,but patients in their 70’s and older tended not to care so much about this.Patients who answered that they had missed doses accounted for 59.8 percent of the total,and missing doses tended to be more frequent after lunch when dosing regimens were three times a day,after meals.Patients desiring the Unite Dose Package (UDP) accounted for 37.9 percent,66.9 percent of whom were not receiving UDPs from the dispensing pharmacy.Informing doctors of these findings will lead to better patient compliance and raise safety for patients.

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Two trials of the Observational Structured Clinical Examination (OSCE) were conducted at Showa University,in 2005¹⁾ and 2006.In the 2 nd trial,2 new test stations (for aseptic technique and patient counseling skills) were added bringing the total to 4 test stations.This paper discusses the issues regarding the preparation and implementation of the OSCE,and its secondary effects.We held a one-day training session for new evaluators to prepare them for their task and the results of a survey conducted to determine the effectiveness of the training showed that it had had positive effects such as decreasing anxiety (2.9 points to 2.1 points : 5 points total) and increasing evaluator confidence with regard to dispensing skills,being an evaluator,and giving feedback to students.The one-day training was therefore useful in that it enabled evaluators to evaluate students with confidence.We provided students with audiovisual learning tools to help them prepare for the OSCE and a survey conducted afterwards showed that 80.6 to 89.1% of them felt the tools were very useful.Another survey regarding the effectiveness of the OSCE,which was conducted after their internship,revealed that it was useful to 67.2% as regards aseptic technique,and 45.1% regarding patient interviews,although 75.6% of students thought that there was discrepancy between OSCE and actual practice regarding dispensing procedures.Effective ways of eliminating this discrepancy are urgently needed.

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