Obesity is one of the most common metabolic diseases,and obesity-associated disorders have reached epidemic proportions.Abdominal obesity in particular has been linked with elevations in total cholesterol (TC),low-density lipoprotein cholesterol (LDL-C),and triacylglycerol (TG),as well as with decreased high-density lipoprotein cholesterol (HDL-C),and is also associated with elevated blood pressure.It has been noted that excessive fat tissue in and around the abdomen leads to the very common disorder of metabolic syndrome but effective prophylactic agents and methods for treating it have not yet been discovered. Amid these circumstances,Bofutsushosan (BF),a Kampo (Chinese herbal medicine) remedy,has been studied as an antiobesity drug for the treatment of metabolic disorders.Specialists in Kampo medicine have prescribed BF for“HimanShou”(obesity with large waist and potbelly) through Kampo diagnosis based on“Shou”(constitution),which cannot be said to be the same condition as the obesity that is prevalent worldwide since it is diagnosed by the procedures of western medicine.Thus in order for BF to be accepted as an anti obesity treatment in modern medicine,much data must be collected on the mechanism by which it reduces fat as well as its safety.There also need to be ethical guidelines for its use for this purpose. With this in mind,we first conducted basic experiments on obese mice and then double-blind,randomized controlled trials on outpatients in an obesity clinic.The aim of this study was to test the effectiveness of Bofutsushosan in clinical practice,in particular for obesity with impaired glucose tolerance (IGT) which is reported to increase the risk of cardiovascular events,using western medical procedures and scientific evaluation methods.
The purposes of the present study were to analyze medication-related data stored in a database to reduce risks associated with the use of medicines brought to hospital by inpatients and to evaluate the effect of pharmacists’real-time checking of patient medication. Pharmacists interviewed patients concerning medicines they brought with them at the time of hospitalization in the Maxillo-Facial and Oral Surgery Departments of Tohoku University Hospital.The data obtained and additional information,such as that on contra-indications and adverse effects stemming from interactions of the medicines with food,were input to a computer database,and immediately made available to other medical staff.Between May 2005 and February 2006,nearly 50% of medicines brought by inpatients were for cardiovascular disorders,gastrointestinal problems and central nervous system disorders (19%,16% and 15%,respectively).Further,53% of them required caution to avoid interactions with drugs administered after hospitalization. Although numerous papers on pharmacist checking systems for medicines brought by inpatients have been published,little information of this type is available to medical staff,in particular to doctors.In the present study,we conducted a questionnaire survey of doctors and nurses to evaluate the necessity of pharmacists doing this kind of checking.The results showed that almost all of the medical staff surveyed felt that such checking by pharmacists was useful because the advice they gave prevented dangerous interactions with other medication given during hospitalization.The findings of the present study suggest that pharmacist management of medicines brought to hospital by patients is essential for ensuring their safety.
We investigated the cause of the softening of soft capsules in the present study and also established a method for the determination of soft capsule hardness using a durometer,an instrument used in JIS (Japanese Industrial Standards),as a means of testing toughness.The results obtained were more or less consistent with the tactile impression of the capsules.Under various humidity conditions,after removal from the press-through package (PTP),capsules showed softening within a few days,in a humidity-dependent manner,and temperature enhanced softening.For soft capsules kept in the PTP at room temperature,almost no change in softness was observed as a result of being isolated from humidity.Compared with soft capsules removed from the PTP,however,when under high temperature conditions,soft capsules still in the PTP exhibited enhanced softening.When the conditions were restored to the initial ones (room temperature,approximately 30% relative humidity) softened soft capsules tended to regain their toughness,except for those that were markedly softened or deformed.In other words,the present study clarified that changes in soft capsule toughness were due to absorption or desorption of moisture and temperature changes.In addition,the softening and hardening of soft capsules was found to be largely reversible.
Losartan is thought to stimulate uric acid excretion but there have been few studies on this effect in Japanese hypertension patients.The purpose of our study was to clarify that losartan decreases the incidence of hyperuricemia.To do this,at 5 hospitals,we investigated the incidence of hyperuricemia retrospectively in patients taking losartan for one year,and made a comparison with other antihypertensive drugs.At 2.9% (7/235)the incidence of hyperuricemia for the losartan group was lower than in the control group,in which it was 6.3% (189/2795).The risk factors for hyperuricemia were sex,age,serum uric acid prior to administration and diuretic use.Adjusted for these risk factors the hazard ratio (95% confidence interval) for losartan was 0.69 (0.27-1.72).Losartan was thus useful for hypertension patients in whom hyperuricemia was a risk factor,since its incidence was markedly lower as compared with other antihypertensive drugs.
We recently reported on a pharmacy-oriented SOAP (hereinafter referred to as P-SOAP) (Jpn.J.Pharm.Health Care Sci.31 : 320-328,2005).In the present study,we created step-up teaching materials whose objective was to educate pharmacists regarding P-SOAP.The purposes of these materials were (1)to achieve a good understanding of P-SOAP,(2)to develop a wide variety of patient instruction items,(3)to aid understanding of patients’drug-related and pathological conditions,(4)to aid pharmacists in learning how to initiate communication,and (5)to help them adapt instructions to patient needs.P-SOAP registry tests were performed before starting the initial practice and 3,5,8,and 11 months after starting it to evaluate the teaching materials. Among 28 pharmacists who participated,16 were able to issue instructions on the use of drugs based on a thorough understanding of the pathological conditions of patients.The results of a comparison based on number of years after beginning employment at drug stores suggested that pharmacists in their first year had difficulty in studying pathological conditions in greater depth,those in the second to third year were able to achieve the goal of issuing instructions on the use of drugs based on a thorough understanding of pathological conditions through the practice of SOAP,and there were variations among those in their third year due to personal ability.Our results overall suggested that the use of the SOAP education materials would be useful for further enhancing pharmacists’capabilities after they had learned about the general aspects of drugs in the first year of employment at a drug store and gained a more detailed knowledge of them during the second year.
The authors attempted to quantify the risks of taking individual medicines or medicines in bags in error in the dispensing process using Technique for Human Error Rate Prediction (THERP).From data on dispensing errors occurring during the period from April,2003 to March,2004 in our pharmacy department,we derived parameters for incident analysis by THERP.We determined that in order to reduce the frequency of dispensing errors,highest priority should be placed on 2 inspection items-(1)taking medicine in error and (2)making errors in dispensing quantities of medicines.We therefore focused on these 2 types of error as important check items under THERP which resulted in reducing their frequency,though the reduction was not statistically significant.In conclusion,our findings suggest that THERP is a useful tool for detecting error-prone aspects of the dispensing process.
In our pre-clinical training program,students acquire expertise in reviewing prescriptions and measurement of powder and liquid form drugs in four stages with the objective of preventing dispensing errors.Through experiencing the preparation of drugs,students learned how to prevent potential errors in their clinical training.The effectiveness of the pre-clinical training program was determined through an evaluation by students and having them think about the causes of errors in drug preparation and measures to prevent them in groups. Our findings showed that the program achieved a significant improvement in risk management awareness.Further,the pre-clinical training increased the motivation of many students and after completing it,some of them said,“It was beneficial to learn the risks in drug preparation prior to practical training”and others,“I want to start working as a pharmacist as soon as possible”.These findings showed that a pre-clinical training program focusing on risk management was effective in helping students to learn about the knowledge and skills required of the pharmacist and increased their motivation prior to taking clinical training.
At Kinki University Hospital,the Institutional Review Board (IRB) was established in 1989 at the time that Good Clinical Practice (GCP) was introduced and since then,it has screened the clinical trials and clinical studies conducted by physicians and the number of persons in the screening committee has been increased.In April,2005,a medical statistician was assigned to the board and preliminary screening was started for clinical studies,which has reinforced the screening process. In the present study,we determined how the content of IRB screening has changed in accordance with responses made to recommendations made by the IRB,finding that the number of recommendations by the IRB had increased 1.88-fold for clinical trials and 4.62-fold for clinical studies.The fact that they covered everything from ethical to scientific aspects indicated the highly significant role they had played. Upon classifying IRB recommendations into three categories : ethical recommendations,scientific recommendations,reliability-related and other recommendations,we found that there had been a sharp increase in scientific recommendations and that there was room for improvement in statistical screening for clinical studies conducted by physicians. The above findings demonstrate the effectiveness of the participation of a medical statistician in the IRB.We would also like to point out the importance of the person responsible for the preparation of IRB minutes (usually a pharmacist) having a knowledge of the scientific aspects of protocols,statistical aspects in particular.
Very little information is available on the quality of generic products and it has recently been reported that anaphylaxy shock occurred when a generic formulation of an injectable cefazolin sodium product was used in a patient before surgery.This suggests that the generic product contained impurities that caused such an adverse reaction.It is therefore important to determine the constituents of generic products and compare them with those of the original products. We analyzed the original cefazolin sodium product and 4 generics of it by means of high performance liquid chromatography in order to determine differences in quality between them.Three impurities were found in the original product and 4 in the generic products,respectively.However,the impurity content of all of the generic products was significantly higher than that of the original product and on analyzing synthetic samples of impurities which could possibly be contained in the cefazolin sodium products,the chromatographic peaks of three of them overlapped with the peaks observed in the chromatograms of the original and generic products. These results suggest that there can be great differences in quality between the original and generic products,and that the impurities might be cefazolin-related substances.We must therefore select generics based on an appraisal of the quality information available for them in order to minimize unexpected adverse reactions and achieve more cost effective and safe therapy.
Since thalidomide was introduced for the treatment of multiple myeloma at Yamanashi University Hospital in 2005,we have been taking measures to ensure its proper use based on a guideline for this purpose provided by The Japanese Society of Clinical Hematology.In the course of our efforts towards this goal,we have supplied patients taking thalidomide with a drug use diary.The diary is given to the patient's caregiver together with thalidomide with the aims of controlling the drug dosage and monitoring the patient's condition when he or she is at home. To evaluate the usefulness of the diary,we had patients,caregivers and attending physicians fill out a questionnaire.The results showed it was a useful means of controlling the thalidomide dosage and potentially helpful to the attending physicians and pharmacists concerned in monitoring patients' conditions when they were at home.However,a problem was noted in the distribution of the diary,which requires to be solved if the diary is to be made as effective as possible.
In cancer chemotherapy,it is essential for pharmacists to fully understand dosing regimens and precautions in the use of anticancer agents to ensure rational prescribing. At the Kanto Medical Center NTT EC,pharmacists are involved in regimen management to ensure effective and safe chemotherapy from the pharmaceutical perspective.In this study,we investigated the usefulness of prescription checking by pharmacists in ensuring rational prescribing. The number of prescriptions for anticancer agents checked by pharmacists during the six months from October 2006 to March 2007 was 1,275 and the total time taken for checking prescriptions,including the confirmation of questionable points and prescription corrections,was 83 hours and 35 minutes.The average time taken per prescription was 3.5 minutes.On each day,prescription checks were conducted by 1 or 2 pharmacists.Of 105 prescriptions,11(10.5%) were corrected by pharmacists,with the corrections concerning inappropriate doses,essential medicines that were missing from prescriptions and duplication of medicines.Such errors occurred despite regular regimen management. Our findings show that prescription checking by pharmacists is useful in ensuring that prescribing is rational and achieves effective,safe chemotherapy.The results of this study also showed that pharmacists need to carry out prescription checking based on an understanding of physicians’intentions,an adequate knowledge of the drugs concerned and familiarity with the electronic medical records system.
We evaluated the quality of parenteral injections (22 products) containing monoammonium glycyrrhizinate,the main extract from the Glycyrrhizae radix.The pH and osmolarity ratio of each product were within the range stated in the package insert. The glycyrrhizic acid,glycine,and L-cysteine concentrations in the injection products were 2.07-2.51 mg/mL,16.0-21.4 mg/mL,and 1.04-1.30 mg/mL,respectively.The concentrations of glycyrrhetinic acid and glycyrrhetic acid-3-Oglucuronide,impurities that cause pseudo-aldosteronism,were 0.173-2.24μg/mL and 0.777-8.29μg/mL,respectively,showing that there was a wide variation in the concentrations of these 2 substances among the products.Further,the results of discriminant analysis on impurity proportions suggested that it is possible to distinguish bulk powders from each other based on impurity contents.In conclusion,it is important to determine the proportions of impurities in glycyrrhizic acid products and their bulk powders in order to assess their quality.
Enbrel Injection is dissolved before use.We investigated the influence of the temperature of the vial containing Enbrel Injection and the water for injection on the reconstitution time of this drug.The procedures for the dissolution of Enbrel were conducted in the order given in the instructions under“Preparation of injection” in the guidebook for self-injection of Enbrel.Completion of reconstitution was designated as the time when no grains or lumps could be observed in a visual inspection.When the temperature of the vial and water for injection were both 5°C,the mean time for reconstitution was 314.8 seconds but when the temperature of the vial was 5°C and that of the water for injection was 25°C,dissolution time was 170.6 seconds.The heat of dissolution of Enbrel in water for injection at 25°C was determined to be 14.2±8.8 J and dissolution occurred by an endothermic reaction. These results indicate that water for injection at higher temperatures increases the speed of dissolution showing the validity of determining the time for dissolution.They also confirm that there is no problem with the existing instructions for the dissolution of the drug,which state that the water for injection should be kept at room temperature and the injection vial kept in a refrigerator.
We investigated the influence of the ampule package in reducing the risk of“one-point cut”glass injection ampules breaking when dropped.Four test products were subjected to horizontal and vertical drop tests from heights of 60 and 85 cm according to JIS Z 0202 in the Japanese Industrial Standards.A novel square ampule cover that was sufficiently larger than the glass ampule and sealed with a polypropylene film markedly reduced the breakage risk (Tukey’s HSD test : P< 0.001),and there was no significant correlation between the height from which ampules were dropped and breakage (analysis of variance : P=0.069). We concluded that the novel ampule cover was useful for the packaging of injectable drugs used in clinical practice as it not only reduces the risk of glass ampules breaking but also prevents scattering of the solutions contained in them.