Information on the pharmacokinetic interactions of 8 statins (atorvastatin, simvastatin, lovastatin, fluvastatin, pravastatin, rosuvastatin, pitavastatin and cerivastatin (already withdrawn from the market)) with other drugs such as itraconazole, erythromycin, HIV protease inhibitors, digoxin and cyclosporine, and food products such as grapefruit juice was collected from the literature, summarized and analyzed. The results of clinical drug interaction(s) were then discussed on the basis of nonclinical interaction information regarding hepatic or intestinal metabolism by cytochrome P 450 and drug transporters such as MDR 1 and OATP 2. In conclusion, due to several complicating factors such as plasma protein binding, first pass effect, lipophilicity/hydrophilicity, and inter-conversion between acid and lactone forms, further clinical pharmacokinetic interaction studies will be needed to predict the likelihood of drug interactions.
Problem-based learning is an educational method whose focus is on developing communication skills and problemsolving ability.In the present study, we designed a communication training program based on problem-based learning to train second-year students in the ability to instruct patients on the use of medicines in a manner that meets their individual needs. The students first determined the various problems of patients in six clinical case scenarios arranged by teachers and then looked for solutions to the problems in textbooks and on the internet.Based on the findings, they prepared leaflets having drug information tailored to individual patients, which used illustrations to aid understanding.The leaflets were then used in role plays with a student and a teacher playing the parts of the pharmacist and patient.Sixteen students and one teacher observed the role play and made objective evaluations, and the teacher who played the part of the patient made a subjective evaluation using sheets for this purpose.The sheet for the subjective evaluation by the teacher included a face scale to indicate patient satisfaction.The training program was conducted twice. A significant difference was noted between the objective and subjective assessments both times the training program was conducted, which confirmed its usefulness.
A prospective comparative study was conducted to assess the efficacy and safety of low-dose steroids for delayed nausea in patients who had received platinum-based chemotherapy. Out of the 46 patients enrolled as our subjects, 21 were given 2 mg of dexamethasone (dexamethasone group) and 23 received no dexamethasone (control group).All patients enrolled were treated with dexamethasone (8 to 20 mg) and an intravenous 5-HT3 receptor antagonist prior to chemotherapy for the prevention of acute emesis. Following chemotherapy, they assessed themselves for nausea and anorexia for 7 days. When these symptoms were noted, dexamethasone was administered to patients in the dexamethasone group at 2 mg for 4 days. As the results of our study, nausea and anorexia were apparently relieved in the dexamethasone group and prolonged nausea and anorexia occurred in the control group. The nausea scores changed from 0.68 to 0.17 and from 0.70 to 0.72, respectively, in the dexamethasone group and control groups, respectively, and the anorexia scale scores from 1.33 to 0.60 and from 1.44 to 1.51, respectively, in the two groups. In the dexamethasone group, the improvement rate for nausea changed from 34.8% to 57.1% and that for anorexia changed from 17.4% to 71.4%, both significantly higher than in the control group. Though one patient in the dexamethasone group experienced mild heartburn, no other adverse events were observed, indicating that 2 mg of dexamethasone was well tolerated. In conclusion, we consider that low-dose steroid therapy in the early stages maybe clinically effective for delayed nausea.
Evidence-based medicine (EBM) is considered to be an important approach in making clinical decisions regarding the care of individual patients. We conducted a drug information training program applying EBM principles (EBM practice) as part of the hospital practical training curriculum for fourth-year undergraduates at Ehime University Medical School, and describe the EBM practice and its evaluation by students in the present report. In the EBM practice, students received two lectures and training on providing drug information using the EBM approach. We gave students a specific question, which required them to read clinical research articles (meta-analysis or randomized controlled study) in order to answer it. The training program consisted of 5 steps : STEP 1 Defining the specific question that needs to be answered ; STEP 2 Finding the best evidence to answer the question ; STEP 3 Critically evaluating the evidence to assess its validity and usefulness ; STEP 4 Applying the results of the critical evaluation in practice ; STEP 5 Presentation of drug information and discussion. After the training, we asked participating students to complete a questionnaire regarding their opinions of the training program and lectures. Almost all of the students felt satisfied with the EBM practice because it enabled them to enhance their understanding of the EBM process. Our findings suggested that the EBM practice was a useful training program for students.
A new type of rubber plug reduces leakage in the Lantus® OptiClick® 300 insulin pen (Sanofi Aventis K.K. ; n-OPC).In order to evaluate this improvement, using a questionnaire, we asked patients whether they had experienced leakage with the pen having the previous rubber plug (o-OPC) as well as concerning the effect of such leakage. Twenty-seven outpatients with diabetes provided responses. In Japan, the pre-filled insulin pen product NovoRapid FlexPen® (Novo Nordisk Pharma K.K. ; FLX) is widely used. As basic testing, we examined the material and structure of its rubber plug, and conducted an insulin injection accuracy test and a puncture resistance test. We also assessed the n-OPC to see how much it prevented the leakage that frequently occurred with the o-OPC. We compared the elasticity of plugs, conducted a puncture resistance test and an accuracy test, and compared how well they fit in the pens. The responses to the questionnaire indicated that leakage increases patient anxiety and required preventive measures to be taken as early as possible. The results of the basic testing showed that there were no problems with the FLX but the o-OPC had problems with regard to all test parameters. For the n-OPC, while the new plug material helped prevent leakage, there were still various points of the product that required improvement.
Training in medication management and instruction on the use of drugs based on the Model Core Curriculum was conducted over two-and-half months on a trial basis.We then conducted CS analysis to determine if there had been any improvement as regards students’evaluation of the training.The results indicated improvement in student evaluation as regards the points:“Ability to give advice on use of medication and explain adverse effects to patients,”and“Have sufficient knowledge and skill to be able to recognize adverse effects from talking to patients and observing their condition”. One of the factors underlying these improvements in student evaluations is thought to be the creation of full-time clinical pharmacist positions.The presence of full-time clinical pharmacists allows clinical training schedules to be properly managed and helps ensure that the training programs are conducted smoothly.In view of the improvement in student evaluations and the above observations, we consider that the creation of full-time clinical pharmacist positions is very important to the implementation of the Model Core Curriculum.
The six-year education system for pharmacy students was established in April, 2006.Under it, the practical training period has been extended in response to the“Model Core Curriculum for Practical Training”which stipulates more rigorous clinical education for students.The Model Core Curriculum has specific behavioral objectives (SBOs) associated with inpatient pharmaceutical services that not only concern the acquisition of the basic knowledge and skills needed for inpatient care but also proficiency in patient interviews and communication with other medical staff.In addition, students must interact with a diverse population of patients who have a wide range of diseases.In view of this, the review of current programs should be conducted as soon as possible to include training matched to all of the SBOs. We developed a training program for postgraduate students of Okayama University focusing on the SBOs of inpatient pharmaceutical care and communication skills.In it, we included role-playing, case report conferences and practical work at inpatient care units in addition to activities based on an original textbook.All students were given two or more medical specialties to deal with.The training program was conducted from April to July of 2006. In the training program all of the students achieved most of the SBOs.The role-playing and conferences meant that every student had equal opportunities to take part in the training, and they participated enthusiastically in discussions during the role-plays and conferences.We felt that our program was good at motivating the postgraduate students and provided them with effective practical training in inpatient pharmaceutical services.
In the present study, we established a practical training program for drug information involving active participation based on the“Model Core Curriculum for Practical Training”. Our subjects were 20 third or fourth year students from 8 universities who underwent practical training at the Department of Pharmacy, Mie University Hospital from February through August 2006.We used small group discussions based on the “KJ method”devised by Jiro Kawakita and simulated meetings of the pharmaceutical deliberation committee in which debate took place.A questionnaire using a descriptive format was administered to evaluate student opinions just before and after the training and a ten-grade VAS (Visual Analog Scale) was applied to the evaluation obtained just after the training was completed. Achievement of individual objectives was 18% in consideration of the number of training hours compared with those specified in the Model Core Curriculum and 92% in consideration of numbers of objectives.Based on questionnaire responses, understanding of the details of objectives tended to be better after the training that before it.VAS scores for satisfaction with the training as regards content and hours were 9.0±1.1 and 7.0±2.0 (mean±S.D.), respectively.The small group discussions based on the“KJ method”were helpful in obtaining the opinions of students and summarizing them in a short period of time and were useful in achieving drug information training based on active participation.The combination of small group discussions and active debate with drug information training enabled the training objectives to be comprehensively achieved.
In recent years, the combined use of kampo medicines and Western drugs has been increasing.Though certain problems may occur when both types of medicines are taken together, they have not been adequately analyzed.To clarify such problems, we conducted a questionnaire survey of outpatients at the Kampo Clinic of Keio University Hospital. More than 50% of the patients being treated at the Kampo Clinic were also being treated at other departments, and the mean number of Western drugs being used in combination with kampo medicines was 1.5.Changes in the use of Western drugs after starting treatment with kampo medicine were observed in 20% of the patients, of whom 80% changed the frequency and/or dose of Western drugs by themselves or began to forget to take the Western drugs. In the future, physicians and pharmacists should make efforts to better understand the combined use of kampo medicines and Western drugs, as well as to improve compliance and avoid adverse effects due to drug interactions.
Recently, as the variety of medicines being used has increased, so has the incidence of adverse drug reactions (ADRs) and the range of different types of reactions experienced.It is thus important to determine causative medicines as soon as possible and prevent them being administered to patients again. With these objectives in mind, we established an ADR reporting system in April 2002.Under the system, doctors report ADRs to pharmacists who determine whether to classify the causative medicine as being contraindicated or subject to careful administration.A drug causing an allergic reaction is considered to be contraindicated and a drug for which an ADR depends on the dosage is considered to require careful administration.If a medicine is classified as being contraindicated, it cannot be administered to the patient in whom it caused an ADR again. Drug information is also shared with patients based on the ADR reports.When an ADR is serious, the pharmacist reports it to the Ministry of Health, Labour and Welfare and the pharmaceutical company.By enabling us to collect and manage ADR information efficiently, the system has been playing an important role in the prevention of ADRs in our hospital.However, we need to further improve it so that we can identify the causative medicines with greater accuracy.
Elcatonin injection is used for the treatment of osteoporosis in Japan.In order to compare the original product with generic versions, we measured the elcatonin content and amounts of impurities in both using high performance liquid chromatography, and observed changes in content with time under the conditions of light exposure and shaking. We found that elcatonin content and amounts of impurities varied among the generics and that changes in content with time under the above conditions for some generics were greater than the changes for the original product.These results suggest that some generic products should not be considered to be equivalent to the original product.
Prescriptions for injectable drugs are frequently modified just before dosing due to sudden changes in patients’conditions.It is therefore highly desirable to have an efficient system that facilitates the thorough management of injectable drugs.In this study, we created an inventory management system incorporating a commercially available automatic dispenser for injectable drugs (YS-APR) and evaluated its effectiveness in daily pharmaceutical care. When using the system, the value of the stock in the automatic dispenser was approximately 50% of the former level, and it could check JAN codes at the time of dispensing which avoided mistakes.There was no significant difference in stocking times between before and after introducing it.Our system not only improved inventory management but also contributed to reducing the risk of mistakes in dispensing injectable drugs.
The purpose of this study was to investigate the drugs prescribed for pregnant women at Tokushima University Hospital in Japan, and to evaluate the risks associated with the use of these drugs during pregnancy according to the pregnancy risk classification systems of the FDA, ADEC and that used in manufacturers’package inserts.Of 496 female outpatients who gave birth at Tokushima University Hospital, 81% had been prescribed at least one drug, and the mean was 4.0 drugs per patient.Analysis of the prescriptions revealed a pattern of drug use very different from that in other countries, in that Kampo (Japanese herbal) medicines were also prescribed.For more than half of the oral drugs prescribed, risks were not given in the FDA and/or ADEC pregnancy risk systems.In addition, there was no listing of pregnancy risks in the package inserts of 20 drugs.We therefore consider it to be very important to develop a globally harmonized system for evaluating the risks associated with prescription drugs taken during pregnancy.