Metastatic breast cancer (MBC) is almost always incurable and median survival is 18-24 months.Although the combination of adriamycin (ADR) and docetaxel (DOC) has demonstrated higher efficacy against MBC,severe myelosuppression and cardiotoxicity have been dose-limiting factors.The purpose of this study was to devise an optimal dosing-schedule for this combination which lessens the severity of adverse effects and enhances antitumor effects.
(I) Dosing-sequence :
Mice were assigned to a simultaneous dosing group (ADR/DOC ; regimen commonly used in clinical practice) in which both drugs were administered simultaneously and 2 intermittent dosing groups (ADR-DOC and DOC-ADR) in which the second drug was administered 12 hours after the first one.In the DOC-ADR group,as compared to the ADR/DOC group,in addition to there being significantly less leukopenia and toxic death,the tumor growth inhibition rate was significantly higher.
(II) Dosing-interval :
When dosing intervals were varied in the 6-24 hour range in the DOC-ADR group,on day 21,body weights were markedly lower for doing intervals of 6 and 24 hours than they were for a dosing interval of 12 hours.
(III) Dosing-time :
For a group treated with ADR and one treated with DOC,adverse effects were least when the dosing times were 21 : 00 and 9 : 00,respectively.In a DOC (9 : 00)-ADR (21 : 00) group in which DOC was administered at 9 : 00 followed by ADR at 21 : 00 both body weight loss and leukopenia were significantly reduced as compared with a DOC (21 : 00)-ADR (9 : 00) group in which DOC was administered at 21 : 00 followed by ADR at 9 : 00.
These findings show that the therapeutic index of combination chemotherapy can be improved by choosing an optimal dosing-schedule.

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Clarithromycin (CAM) dry syrup is widely used for pediatric infections and nine generic versions of this product are now available on the Japanese market.The purpose of this study was to compare the pharmaceutical quality and palatability of the original CAM dry syrup with the nine generic versions.The quality evaluation included assessments of uniformity based on particle size and dividing methods.The particles of each product were divided into four groups on the basis of particle size and the mean CAM content of each group was determined.With the original product,the content was almost 100% for every particle size group,but for several of the generic products,the content was not uniform between particle size groups.Uniformity was lower for products divided by hand than those divided by machine and for many of the generic products,content uniformity exceeded the evaluation standard (JP XV),especially in the case that they were divided by hand.
In the evaluation of palatability which included the parameters of bitterness intensity (gustatory sensation test),ease of suspension and dispersion,and precipitation characteristics,for some generic products,the bitterness intensity increased over time.It was possible to achieve uniform suspension and dispersion for the original product but not for several of the generic products.As for precipitation characteristics,one of the generic products exhibited separation over time.

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We developed a reporting system for the identification of drugs brought to hospital by inpatients and introduced it at our hospital in April 2006.Using Microsoft^® Access 2000,the system identifies drugs from the information input.It prints out reports on the results of identification,orders for re-dispensing medicines (pulverized drugs,one-dose package drugs,etc.) and management tables for the drugs.Our system also enables us to prepare information sheets on the relationship between drugs brought in by inpatients and drugs prescribed during hospitalization for patients who are to be discharged from hospital.Making such information available to physicians and nurses is an efficient way of avoiding the risk of drug interactions.The re-dispensing information provided enables us to make effective use of drugs brought in by inpatients.

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In the treatment of cancer,radiotherapy is equally important to chemotherapy,and the pain arising from the adverse reactions of esophagitis and stomatis is treated with sodium aliginate (AL-Na).
We decided to try cooling AL-Na because it was felt that doing this would enhance the analgesic effect.When cooled,the time of adhesion to the affected part was longer than that for AL-Na at room temperature and the pain relieving effect was greatly enhanced.

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To assess the current situation of dispensing errors in pharmacy practice and analyze their causes,we conducted a survey of fourth year students (n=20)at Gifu Pharmaceutical University during their practical training in the pharmacy department in 2005.The rate of dispensing errors was a high 7.8%,and errors relating to names and specifications of drugs accounted for 42.1% of them.Precautions printed in colour seemed to be ineffective in preventing mistakes by the students.When analyzed in terms of day of the training,dispensing errors were most frequent on the 1 st (Monday) and 4 th (Thursday) days of the practice.These results indicate that dispensing practice should be shortened on the 1 st day to allow time for an orientation lecture and on the fourth day,students need to pay more attention to avoiding careless mistakes.On a daily basis,the rate of dispensing errors was highest between the early morning and 11 a.m.,and from 2 p.m.to 3 p.m.From this we inferred that,regardless of the workload,errors often occur soon after the start of pharmacy practice,both in the morning and afternoon,so students need to be more alert in the morning and after lunch.These results indicate the need for lectures in which students are taught about the fundamentals of dispensing and ways of preventing mistakes prior to the start of pharmacy practice.

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In cancer chemotherapy,avoidance of adverse effects,improvement of quality of life (QOL) and palliative care are clinically important types of supportive therapy.The aim of this study was to clarify the clinical usefulness of pharmaceutical care in cancer chemotherapy and to do this a survey of thirty-five patients with malignant hematological diseases was conducted from March 2005 to August 2005 at the Social Insurance Kyoto Hospital.
The survey revealed that there had been 35 cases in which pharmaceutical intervention had been proposed in 15 patients.Interventions related to chemotherapy protocols accounted for 8.6% of the total (3/35 cases) while the remaining 91.4% related to supportive therapy of which prescription changes accounted for 40.0% (14 patients).Among the 35 cases of proposed prescription changes,27 (77.1%) were accepted.
They comprised 14 cases of measures to avoid adverse effects,3 cases of supportive therapy to improve QOL,3 cases of palliative care and 7 cases relating to optimum dosages.Supportive therapy to directly mitigate the adverse events of cancer chemotherapy thus accounted for 20 cases of intervention (74.1%).In 24 of the 27 cases of prescription changes (88.9%),adverse effects were avoided or there was an improvement in symptoms.Our findings show that pharmaceutical care functions well in supportive therapy,and is clinically useful in cancer chemotherapy.

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Forty-two patients were surveyed regarding prescription changes and incidence of adverse events after undergoing renal transplantation at Gifu University Hospital.Immunosuppressive therapy including methylpredonisolone,tacrolimus,mycophenolate mofetil and basiliximab (monoclonal antibody against human interleukin-2 receptor) was administered after renal transplantation.As there was a significant increase in plasma concentrations of total cholesterol in 16 patients (171.0±19.4 mg/dL to 234.7±20.8 mg/dL) and a significant elevation of uric acid levels in 13 patients (5.3±1.3 mg/dL to 8.7±0.5 mg/dL) (P<0.01),drugs for hyperlipidemia and hyperuricemia were also prescribed for these patients.In addition to these changes,anti-osteoporosis agents were more frequently prescribed after transplantation.In contrast,there was a reduction in prescriptions for anti-hypertensive drugs and anti-hyperkalemia agents were reduced after the operation.The hyperlipidemia and hyperuremia were presumably adverse effects of the immunosuppressants and since they are known risk factors of graft rejection,we feel that it is important to check laboratory data and prescriptions for patients who have undergone renal transplantation in the practice of pharmaceutical care.

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By means of dissolution tests,we compared the quality of generic oral products (amantadine,ticlopidine,loxoprofen,diclofenac,brotizolam and clarithromycin) that had already undergone the official post-approval reevaluation of quality with the innovator products.The generic versions of ticlopidine,loxoprofen,diclofenac and brotizolam all met the official dissolution test standards but generic amantadine did not.Conducting the dissolution testing of generic clarithromycin under acidic conditions (pH 3.0) in observance of the revised guidelines which will come into force in November 2007 produced a significantly lower dissolution rate than that for the innovator product suggesting that a change in the test conditions should be considered.
On investigating the propriety of the simple suspension method for the testing of oral products,in the case of loxoprofen we found that there was quite a variation in the results among products.
Our findings show that more accurate information is needed for generic products.

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The 6-year pharmaceutical education curriculum commenced in April,2006,and the long-term pharmacy practice lasting 2.5 months will be introduced in 2010.In preparation for this,it became compulsory for 4 th year students of our university to take part in a 2-week course in pharmacy practice in 2006.To evaluate the result,we performed a questionnaire survey in which 404 students who had completed the practice were asked about what they felt were the burdens on them in the practice,their degree of satisfaction,what they had learned,and problems in the practice at the pharmacies where they undertook it and at our university.We then analysed the problems within our university in order to make improvements.
The burden on the students due to lack of knowledge was greater than the time-related burden,psychological,or physical burden.However,the students seemed to have become aware of their responsibility as pharmacists in the clinical setting as well as that to society and for most of them,the degree of satisfaction after the practice was greater than the degree of eagerness before it.Though they felt that the content of the practice at many institutions was rich and varied they felt the lectures at university before it were inadequate.While the results of this survey showed that most students obtained a sense of fulfillment from the practice and had no major problems,for a few the degree of satisfaction after the practice was less than the degree of eagerness before it.
Our university should now study the burdens felt by the students with a view to taking measures against them in the long-term pharmacy practice beginning in 2010.We felt that cooperation between the university and pharmaceutical associations was necessary in order to solve the problems quickly.

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Medication Notebooks have been expected to play an important role in avoiding risks associated with medical treatment.However,our findings from an initial investigation in which we asked patients about what they desired from Medication Notebooks by means of a questionnaire were that many patients carried more than one notebook,never carried one with them,did not show the notebook to anybody other than their family doctor or did not feel they were useful.In order make medication notebooks more useful to patients,we made“information stickers”for them which include questions frequently asked by patients,medication-related information such as laboratory data sheets and blood pressure graphs,and important dosage instructions and other important information.The stickers were designed to have a strong visual impact and be easy to understand and were inserted in notebooks when giving patients instructions on their medication.
Doing this resulted in increase in the percentage of patients carrying the notebook at 9 out of 11 pharmacies which adopted the information stickers as opposed to an increase in the carrying rate at only 3 out of 9 pharmacies which did not adopt them,a significant difference (P=0.035).In another questionnaire in which supervising pharmacists were asked whether the information stickers were a useful addition to that in the Medication Notebook,they responded that they were useful in communication with patients about notebooks and teaching them about their medication,and enhanced their knowledge.In conclusion,the adoption of our information stickers can make notebooks more patient-oriented and meet their expectations to a greater extent.

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In recent years,there has been a growing tendency to use generic drugs though there have been few studies on their efficacy and safety.However,there have been reports of decreased efficacy and more adverse effects with the use of generics which indicates that they are not equivalent to branded products.We retrospectively compared the efficacy and safety of generic metformin hydrochloride (Medet^® ) with the branded product (Merbin^® ) when a switch was made from the branded product to the generic.Regarding efficacy,there were no significant differences in Hemoglobin A₁c (HbA₁c) levels between before switching to Medet^® and three months after switching (6.89±0.77%→6.70±0.70% (at time of switch)→6.80± 0.85% : N.S.).We also analyzed drug safety using ALT,AST,γ-GTP,ALP and found no specific problems related to the switch to Medet^® .However an investigation of 274 subjects after switching to Medet^® revealed that there had been adverse effects in 10 of them.
While our findings suggest that the branded and generic products of metformin hydrochloride have similar efficacy,attention should be paid to the appearance of adverse effects after switching to a generic version.

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From the viewpoint of safety management,the examination of incompatibility by pharmacists and their provision of information on this subject are essential in ensuring that drugs are used properly.
In the present study,we investigated the situation regarding the enforcement of flushing,which is carried out to prevent incompatibility on injection,by means of a survey of members of the nursing department.The results showed that nursing staff recognized the necessity of flushing to a certain extent,but no standards had been established regarding the kinds of drugs that need to be flushed,or the volume and rate of flow of the flushing fluid.This suggests that pharmacists could do more in providing information on flushing and advising nursing staff concerning it,and in the survey many staff said that they would welcome the provision of information on flushing by pharmacists.The results of the survey thus showed that pharmacists can play an important role in drug safety management.

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