A training program incorporating a Problem-Oriented System (POS) with Problem-Based Learning (PBL) was introduced into the clinical pharmacy course of the pharmaceutical sciences graduate school at Fukuoka University. The POS training consisted of 7 processes for each of the 3 clinical case scenarios that we designed (case # 1 : asthma, case # 2 : hypertension, case # 3 : hyperlipemia). The requirements on the participants in finding and solving problems were increased during the training in the numerical order of the 3 cases. Our participation consisted of managing the POS training schedule and role-playing as patients (process 4). Students made SOAP notes on the role-playing (process 6) and looked for solutions to the problems (process 7). For each clinical case, students gained an understanding of the principles of pharmacotherapy, drew up hypothetical schemes for pharmaceutical care, worked out the problems and discussed them together in small groups. On conducting a questionnaire survey of the students' impressions of the training program, they made meaningful comments with regard to working together in the group discussions and the handling of problems. These findings indicate that our original POS program involving PBL was useful in raising students' problem solving skills and would help them to provide optimum pharmaceutical services.
The pharmacokinetic information provided in the package insert of the original pravastatin sodium product and the package inserts of 22 pravastatin sodium generics was examined. Pharmacokinetic parameters had been determined following the oral administration of 10 mg of pravastatin sodium. Package inserts were examined to see if all parameters were given or not and the ratios between the individual pharmacokinetic parameters of the original product (Op) and those of the generic products (Gp) were calculated using the formula PPr=Gp/Op (PPr= pharmacokinetic parameter ratio). While the package insert of the original product gave values for all of the pharmacokinetic parameters, i.e., Cmax, Tmax, T1/2, and AUC, the package inserts of only 10 of the 22 generic products had values for all four parameters. The PPrs of the generic products were 2.63 ± 0.61, 1.03 3.61 (mean ± S.D., min-max) for Cmax, 0.55 ± 0.09, 0.45-0.80 for Tmax, 1.98±0.78, 0.89-3.92 for T1/2, and 2.95±1.10, 1.25-5.23 for AUC. Though these results show that the generic products are definitely bioequivalent to the original product, many of them fall outside the acceptability limits (0.8-1.25) for bioequivalence when only the information in their package inserts is compared. Therefore, the package inserts of generic products should specify the name and manufacturer of the reference product used in the bioequivalence studies and also give the pharmacokinetic parameters determined for it. This information will make the package inserts of generic products more useful.
Two methods are commonly used to analyze the pharmacokinetics of ABK : the Sawchuk-Zaske (SZ) method, which uses a one-compartment model, and the Bayesian (BS) method, which uses population parameters based on a two-compartment model. Since it seemed possible that serum ABK concentrations predicted from pharmacokinetic parameters calculated by these two methods might differ, we carried out a comparison. We performed TDM after administering ABK to 18 patients with pneumonia and evaluated the peak and trough concentrations predicted by the two methods. The predicted between peak concentrations for the SZ method and BS method were well correlated and so were the predicted between trough concentrations for both methods. However, the peak and trough concentrations predicted by the BS method were higher than those for the SZ method by 3.9± 1.5 and 1.1± 0.8μg/mL, respectively, which suggests that actual peak concentrations could be lower than the therapeutic range if the target peak levels are set between 7 and 11μg/ mL when designing the dosage regimen by the BS method. We also compared measured values with values predicted based on patients' pharmacokinetic parameters (population means) using the initial dosage design function of TDM software for Habekacin ® (Research Committee for Anti-MRSA Drugs). The relationship between the measured values (y) and the predicted values (x) was represented by the regression equation y=1.075x -0.309 (R2= 0.729, n= 36), demonstrating the usefulness of the initial dosage design.
We conduct a 60 min practical training course in the use of bronchial asthma inhalation devices containing placebos for fifth-year undergraduate medical students and fourth-year undergraduate pharmacy students. The purpose of the training is to help students gain a better understanding of the inhalation technique and the importance of proper instruction on inhalation. In this report, we describe the practical training course and the evaluation of the metered-dose inhaler (MDI) and dry powder inhaler (DPI) by students. The course consists of 4 parts : 1. Explanation of the characteristics of different kinds of inhalation drugs and inhalation devices ; 2. Using the instructions, students practice of each step of the inhalation technique for MDI and DPI (diskhaler and diskas) inhalation devices containing placebos for patient practice ; 3. Students written evaluation of the operation of the inhalation device and instructions on it for each step assuming that the subject is an elderly patient or a younger adult patient and 4. Explanation of the need to confirm that patients have grasped the inhalation technique and the necessity of gargling after inhaling steroids. The 78 fifth-year medical students and 7 fourth-year pharmacy students who took our practical training course in 2003 said that compared to MDI and Diskhaler, Diskas was easier to operate and to provide instruction for. According to the results of a questionnaire given after the training, the students were satisfied with the practical training program on the use of inhalers for bronchial asthma.
Although the daily use of aspirin reduces the risks of myocardial infarction, stroke and vascular death in patients at high risk of developing vascular disease, the use of preventative aspirin therapy in patients with no history of cardiovascular disease is controversial. For this reason, we studied the benefits and risks of aspirin therapy in the primary prevention of cardiovascular disease, in particular for aspirin at low doses. On performing a meta-analysis of 4 randomized trials with low-dose aspirin therapy for primary prevention, the low-dose aspirin was found to significantly reduce the risk of myocardial infarction (summary odds ratio (OR), 0.64; 95% confidence interval (CI), 0.56 to 0.74). Though the all-cause mortality (summary OR, 0.94; 95% CI, 0.84 to 1.04) was not significantly affected by aspirin therapy, it significantly increased the risk of gastrointestinal bleeding (summary OR, 2.03; 95% CI, 1.55 to 2.65). These results suggest that low-dose aspirin therapy is beneficial in the primary prevention of myocardial infarction, but it increases the risk of gastrointestinal bleeding
As a preliminary study for this purpose, we investigated the reasons for hospitalization and medications for 302 patients to whom we provided pharmaceutical care in this ward between April 2002 and March 2003. Based on the results, 8 types of drug (sulfonylureas, α-glucosidase inhibitors, biguanides, pioglitazone, HMG-CoA reductase inhibitors, fibrates, histamine H2 receptor antagonists, allopurinol) were selected for special monitoring and monitoring sheets were prepared for following up patients who had started to use such drugs within the last six months, and those at high risk of adverse drug reactions. Patients were monitored by 3 pharmacists who periodically audited the patients' monitoring plans. As a result of these activities, physicians accepted prescriptions proposed by our pharmacists for 9.8 % of the patients, in consideration of the early detection and prevention of adverse drug reactions. Thus, our standardization of the monitoring of adverse drug reactions in hospital pharmaceutical care proved to be effective for the early detection and prevention of adverse drug reactions
The administration of glimepiride brings about a decrease in blood glucose through an insulin secretion promoting action and an insulin resistance improving action. However, there has been no definite factor for predicting whether it will be effective in doing this or not. Thus in order to use glimepiride in a better way, we decided to evaluate the usefulness of pre-heparin serum lipoprotein lipase mass (preLPL) in determining insulin susceptibility, a patient background factor that influences the effectiveness of glimepiride in improving blood glucose. Changes in body weight, blood glucose and lipid metabolism were investigated during administration of glimepiride in 52 patients with Type 2 diabetes who visited our clinic during a 6 month period, when the dose was 3 mg/day. After six months of administering glimepiride, preLPL had increased by 20 ng/dL (p< 0.05). The background factors found to contribute most significantly to improving blood glucose levels were HbA1c greater than 8% (p< 0.01) and preLPL below 50 ng/dL (p< 0.05). These results suggest that the preLPL level would be a useful background factor in predicting the efficacy of glimepiride in improving blood glucose.
It has been reported that TPN (Total Parenteral Nutrition) causes many adverse events, among them hepatic dysfunction. In the present study, we investigated the occurrence of hepatic dysfunction in patients receiving TPN through laboratory measurement of serum AST and ALT levels, in consideration of TPN composition and co-administered drugs. Twenty-eight patients were enrolled for this study, all of whom had received TPN and been discharged without complications. In the selection process, patients who were not operated on or had lung cancer were excluded. The average age was 68.2 9.8 years and average period of TPN was 18.2 ± 10.0 days. The subjects were divided into a normal and an abnormal group, the former being normal for both AST and ALT serum levels, and the later abnormal for both AST and ALT levels. In the abnormal group, there was a tendency for subjects to have received TPN for a longer period, for the NPC of the TPN to be higher and free amino acids to be lower as compared with the normal group, although these differences were not significant. The NPC/N ratio was in the normal range, although it was higher in the abnormal group than in the normal group. Though the percentage antibiotic and H2-blocker use was slightly higher in the abnormal group, this difference was not significant. In the absence of significant differences in such factors between the groups, we were unable to pinpoint the cause of the hepatic dysfunction so this issue will require further investigation.
Recently the use of dry powder inhalers (DPIs) (steroids, long acting β agonists, etc.) has been increasing, and we use many different types of inhalation medicine in our hospital. Though it is difficult for medical staff other than pharmacists to instruct patients on the use of inhalers and check that they are using them properly because methods of use vary so much among products, the assistance of nurses in instructing patients is required when pharmacists are off duty. We therefore felt the need to develop a standardized instruction procedure by which nurses can instruct patients and make sure that they are using inhalers correctly. Based on the results of questionnaires given to nurses and patients and product package inserts, we prepared an instruction sheet for the use of inhalers and evaluated its effectiveness. The instruction sheet proved to be very helpful to nurses who were unfamiliar with instructing patients on the use of DPIs and the instruction was well understood by patients the first time it was given.