In the treatment of tinea unguium (pulse therapy) using itraconazole preparations,the dose is large and can vary widely.For example,it could be 200mg (4 capsules) per single dose or 400mg (8 capsules) per day.In this study,we developed a novel solid dispersion preparation of itraconazole (itraconazole SD) that could be taken easily and safely even by elderly patients with limited swallowing ability.We also investigated dosage forms of itraconazole SD that can be taken by the standard method of swallowing tablets with a glass of water or as a suspension of disintegrated tablets in a glass of water.Further,in a bioequivalence study in humans,we found that itraconazole SD (test product) was bioequivalent to an innovator product (Itrizole capsule 50)when ingested orally in the normal way or as a suspension in water.
Our results suggested that the test product would be useful for patients who find it difficult to take several capsules or tablets at one time.In addition,the rapid disintegration of the test product enabled a suspension to be prepared easily and quickly.Furthermore,a suspension of the test product did not obstruct a thin tube (8 French) because the solid dispersion includes an enteric polymer,which does not dissolve in water,and the mean particle diameter is maintained at less than 120 μm in its preparation.Therefore,the test product would also be useful in the case of tube administration.

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The basic inhalation procedures for the Dry Powder Inhaler (DPI) and the pressurized Metered-dose Inhaler (pMDI) in the control of bronchial asthma are very different.Effective methods of instructing patients on the use of the pMDI have already been reported and we considered effective ways of instructing patients on inhalation with the DPI since none had really been established,for instance with regard to the basic inhalation procedure and inhalation persistence time.We considered that the inhalation persistence time for DPI should be 1 second or more.With this inhaler,we found that it was effective to use an instruction sheet,a practice device,and an inhalation circuit tester in instructing patients on inhalation with it.
In conclusion,patients should be made aware of the importance of a persistence time of at least 1 second as well as the inhalation velocity,and any method of instructing them on inhalation procedures should be easy to understand.

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To help ensure the proper use of anti-Methicillin-resitant S.aureus (MRSA) drugs,we developed a system for prior notification of the use of these drugs,which is incorporated into the physician order-entry system.The setup also includes a Therapeutic Drug Monitoring (TDM) order-system,which is booted automatically when a physician orders anti-MRSA drugs other than linezoride.Our system allows pharmacists and members of the infection control team to make detailed checks of notifications and dosage regimens.
In this study,we evaluated the notification system from the viewpoint of the proper use of anti-MRSA drugs.The total number of vials of anti-MRSA injections consumed decreased significantly after its introduction while the number of orders for TDM doubled as compared with before system introduction.Twenty percent of TDM orders through the new system were those which pharmacists had requested physicians to raise based on clinical data and drug regimens.By helping ensure the proper use of anti-MRSA drugs,the new system has improved clinical outcomes.

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There are many types of medication error,which include those relating to dosage,wrong medication given to patients,administration route,medication strength,falls and patient care.In order to reduce medication errors,we analyzed 1601 errors reported at Tokyo Teishin Hospital over a period of one year.As the most frequent medication errors were made by nurses,we analyzed the medication-related tasks conducted by nurses in all 12 wards of our hospital.Medication-related tasks took up an average of 13.5 hours of their working time,which accounted for 15% of total working hours,and most of these them were conducted in the daytime.As for the major tasks,giving drugs to patients took up 26.7% of the time,instructing patients regarding compliance 20.7% and making arrangements for the administration of drugs to patients 26.6 % (non-injection drugs 16.3%,injections 10.3%).
In order to prevent such medication-related errors,from 7 : 30 to 19 : 30,pharmacists performed all medication-related tasks instead of the nurses.We were able to prevent 26 instances of medication-related errors due to physicians in a period of month.These errors primarily concerned the continuation and/or discontinuation of drugs,protocol errors and medication given in error.Our findings suggested that it would be difficult to prevent them by only examining prescriptions in the dispensing room and concluded that errors could be more effectively prevented by having all medication-related tasks in wards performed by pharmacists.

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Metronidazole (MTZ) ointments,which are indispensable in the treatment of cancerous malodor,are not yet commercially available at pharmacies in Japan.In view of this,we prepared two MTZ preparations,MTZ-Hydrophilic ointment (MTZ-Oint) and MTZ-Carbopol^® gel (MTZ-Gel),and supplied them to patients at St.Luke’s International Hospital.MTZ preparations should be preferably soft and easy to spread in order to be applied to cancerous skin ulcers.We therefore conducted a sensory evaluation of the spreadability,viscosity,usability and other aspects of the texture of MTZ-Oint and MTZ-Gel with the help of nurses taking care of the patients.
Both MTZ-Oint and MTZ-Gel were adequate in terms of softness and spreadability,although MTZ-Gel was better in these respects than MTZ-Oint.We also examined the stability of the MTZ preparations under several storage conditions,finding that MTZ-Oint was stable under all of the storage conditions but MTZ-Gel had to be kept at room temperature in order to preserve its appearance and quality.These findings should be invaluable in the development of more effective preparations in the future.

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For infection control purposes,we conducted microbial surveillance targeting the air,floors,and sinks at approximately 250 locations from 1999 to 2004.Annual changes in the average number of microbial isolates from air,floor,and sink samples were not correlated but changes in particular sampling items were correlated.Hospital wards where there was greater movement of people produced larger average numbers of isolates than other parts of the hospital,for example examination rooms.We found that the average number of isolates from air and floor samples was higher when a new hospital ward was under construction as well as just after its opening.Methicillin-resistant Staphylococcus aureus (MRSA) was frequently isolated from floor samples (68.8%) and Pseudomonas aeruginosa was isolated from both floor (10.3%) and sink (89.7%) samples.The numbers of MRSA and Pseudomonas aeruginosa isolated from hospital ward samples were larger than those from other parts of the hospital.
Our microbial surveillance clearly showed that the distribution of environmental bacteria changed in the hospital overall rather than for individual units and was affected by human activity and environmental changes.Furthermore,the species of bacteria isolated from the air,floor,and sink samples were different.Therefore,our results suggest that it is important to address the sanitization of the hospital environment as a whole,not on a ward by ward basis.

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While chemotherapy with mFOLFOX 6 is the standard treatment for colorectal cancer,the preparation of the drugs for it takes longer than for other chemotherapy regimens.With the aim of reducing patient waiting time in the hospital,we established a system in which the sterile preparation of the drugs for mFOLFOX 6 therapy is conducted in two parts,in accordance with the scheduling of the first and second stages of administration.Once prepared,the drugs are transported to the chemotherapy room.Doing this achieved a significant decrease in the time that patients must wait for drugs to be prepared in the hospital pharmacy,of about 37 minutes.Our system should be effective in hospitals that require drugs to be transported for structural reasons,and is also applicable to FOLFILI.Our basic aim in preparing the drugs in 2 stages was to reduce the time that patients have to wait to start chemotherapy while keeping the overall preparation time the same to maintain safety,which we feel will contribute to improving patient QOL.

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To pharmacists,DEM (drug event monitoring) means the monitoring of events in patients taking certain drugs.We recently cooperated with pharmacies belonging to the Chiba Pharmaceutical Association to monitor events for bisphosphonates and raloxifene.These drugs were chosen because some of them have short usage records,as they have not been on the market for very long and have complicated dosing requirements.
Pharmacies questioned patients who had been prescribed bisphosphonates such as etidronate disodium,alendronate sodium hydrate and sodium risedronate hydrate,or raloxifene hydrochloride with regard to compliance and post-dosing events.The proportions of patients who forgot to take their medication were significantly greater for alendronate and risedronate,which have complicated dosing regimens,than raloxifene,which has less complicated dosing regimens.As for adverse events,the percentages of patients who had gastrointestinal disorders were 15.8% for etidronate,7.9% for alendronate,5.7% for risedronate,and 6.1% for raloxifene.Further,incidence of gastrointestinal disorders was higher in patients taking stomach medications such as antacids,gastric acid-secretion inhibitors and gastric mucosa protectors together with alendronate or risedronate.
In the present study,pharmacists’questioning of patients taking bisphosphonates or raloxifene clarified the status of compliance and occurrence rates of adverse events.Based on its results,we feel that more efforts should be made to collect patient information and counsel them on their medication in order to enhance the effectiveness and safety of drug therapy.

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Compensation for health problems caused by clinical trials is a serious economic concern for their subjects.Documents concerning compensation arising from clinical trials considered by the Institutional Review Board (IRB) are“Compensation for Damage to Subject Health”and“Explanation of Informed Consent”.In the present study,we conducted a comparison of the compensation details of these 2 documents.
We found that until 2002,documents submitted for most clinical trials had only been a copy of an insurance policy.In 2002,liability insurance policies were submitted to the IRB more often than compensation insurance policies but after this,the number of compensation insurance policies gradually increased and there were more of this type of policy than compensation insurance policies from 2004 onwards.When we asked sponsors to present documents giving detailed information on compensation in 2003,more than 80% submitted them.On the other hand,the submission of documents concerning informed consent did not increase.This showed that the details of compensation had not been fully explained to trial subjects.It has been said that half of trial subjects do not understand compensation details and our study showed that this is because the explanatory materials on compensation are inadequate.

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We examined the influence of the type of infusion pump and the physical properties (viscosity and surface tension) of paclitaxel (PTX) solution on the infusion rate of PTX.We diluted PTX to make 5% glucose injection solutions having a volume of 250 mL and set the infusion rate of the infusion pumps at 250 mL/h.The infusion rate of a PTX solution was almost the same as the rate setting when a flow rate control type infusion pump was used but the infusion rate of a PTX solution was slower with a drip sensor control type infusion pump and infusion took about 1.7 times as long as the rate setting.We therefore recommend using a flow rate control type infusion pump.
When infusing the weekly dosage of PTX using a drip sensor control infusion pump,we realized that infusion of the PTX solution could be finished within the scheduled time by setting the infusion rate 1.7 times faster.Further,our results indicated that the factor delaying the infusion of the PTX solution with the drip sensor control type infusion pump was not the increase in viscosity of the PTX solution but a drop in surface tension due to the surfactant in the PTX solution.

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It is important for pharmacy students to understand the structure of dispensing fees in the health insurance system if they are to participate actively in on-the-job training in a community pharmacy.While the major task of community pharmacists is to contribute to patients through dispensing medicines and providing information on prescription drugs,their professional skills are evaluated under the dispensing fee system.We introduced a program to help students understand the calculation of dispensing fees as part of their training in community pharmacy practice at our pharmacy school and in the present study,evaluated the program by measuring the level of satisfaction of students who participated in the program and noting changes in their examination scores afterwards.
Questionnaires and paper tests were given to students before and after training.The results showed that 97.7% of students were satisfied with the training program,and their scores improved from 0.87 to 4.34 (5=full marks).Based on multiple linear regression analysis,four factors-acquisition of new knowledge,training procedure,willingness to learn more,and level of interest before training-influenced the level of satisfaction.Though some students expressed negative opinions concerning the volume of material to learn and the duration of the program,analysis showed that these factors did not significantly influence the level of satisfaction.We considered that the reason for such opinions could be the use of drills in teaching and thus the program should be improved by introducing more adult-oriented techniques.

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As the number of medicines that patients bring with them on hospitalization is expected to increase with the introduction DPC system and patient co-payment rates rise,it will be necessary to make rules for the safety control and identification of medicines.However,one dose packages and cutting tablets into halves reduces the ability to identify the medicines that patients bring with them and their medicines may include those requiring greater caution,such as oral hypoglycemic agents.In view of this,we investigated the use of symbols on tablets and capsules by pharmacists for identification purposes as well as those on oral hypoglycemic agents.We found that a lot of pharmacists identify medicines only by identification numbers,though only a few medicines can be uniquely identified using such numbers,and that it became more difficult to identify tablets uniquely when cut in a half using the secant.It is therefore necessary to make rules that all related staff can use to identify oral hypoglycemic agents and other medicines requiring caution,not only for the identification of medicines that patients bring with them but also for identifying medicines in outpatient and emergency departments which is a frequent daily task.

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Providing pharmaceutical management to inpatients is an important part of the work of hospital pharmacists.However,there are few opportunities in postgraduate education to receive training in pharmaceutical management for inpatients.We conducted a group work (GW) workshop on auditing pharmaceutical management for inpatients and a questionnaire survey on the“status of audits of pharmaceutical management for inpatients”,“level of understanding of audits of pharmaceutical management for inpatients”and“satisfaction with the planning and management of this workshop”.
We performed an absolute evaluation and customer satisfaction analysis (relative evaluation) of the survey results which showed that the important issues in“improving the status of audits of pharmaceutical management for inpatients”were“to introduce audits in respective institutions”.In addition,the important issue in“improving the level of understanding of audits of pharmaceutical management for inpatients”was to“perform pharmaceutical evaluations”Furthermore,the important issues in improving the degree of“satisfaction with the planning and management of this workshop" were“date and place of the workshop”and“content of simulated cases”.The mean score for“GW is useful for understanding and practicing the tasks of this workshop”was the highest,suggesting that GW training was effective because its participants could immediately apply the knowledge obtained in lectures.

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Tacrolimus is an immunosuppressant which is usually administered to reduce the incidence of graft-versus-host-disease (GVHD) during allogeneic hemopoietic stem cell transplantation.The trough levels of tacrolimus are usually used as an index for monitoring pharmacokinetics and we conducted a pharmacokinetic analysis of the usefulness and validity of trough level monitoring following its oral administration.
The mean bioavailability of tacolimus in 19 subjects was 34±14.1%.There appeared to be a statistically significant correlation between trough levels and the area under the curve (AUC) (AUCpo (0-12)=15.46×trough level-8.64,R²=0.92),and this correlation seemed to be little influenced by subject background or drug-drug interaction.Using our results we made a table for the conversion of trough levels to AUC,since the immunosuppressive effect of tacrolimus was considered to be correlated with the AUC.
The conversion table will enable us to predict AUC values based on estimated target trough levels when switching the administration route from continuous instillation to oral administration,and will thus help ensure the appropriate use of tacrolimus in treatment.

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