Combination therapy consisting of interferon (IFN) alpha 2b and ribavirin is effective for IFN-tolerant chronic hepatitis C. However, this therapy often causes anemia and other serious disorders of the red blood cells (RBC). On the other hand, IFN monotherapy causes leukopenia and thrombocytopenia. Up till now, little information has been available on the differences in adverse effects on blood cells between IFN monotherapy and IFN combination therapy with ribavirin. In this study, therefore, we investigated changes in RBC, white blood cells (WBC), platelets and hemoglobin levels in patients who underwent IFN monotherapy (n=6) and IFN combination therapy with ribavirin (n=22) in the Department of Gastroenterology of Sapporo City General Hospital. There were marked decreases in RBC and hemoglobin levels in the initial stage (1 to 4 weeks) of combination therapy and their levels did not recover in the remaining period of the therapy. In contrast, there was no appreciable change in these levels in the case of IFN monotherapy. WBC and platelets decreased in all patients in the initial stage for both therapies and there was no significant difference in their levels between monotherapy and combination therapy. One month after completing the two types of therapy, WBC and platelets had returned to their initial levels. On the other hand, it took 2 months for RBC and hemoglobin levels to recover. These data suggest that combination therapy with ribavirin specifically increases the incidence of anemia as compared with IFN monotherapy and that it is important to monitor RBC and hemoglobin levels after completion of IFN combination therapy with ribavirin.
In August 2002, the Pharmaceutical Society of Japan proposed “Model Core Curriculum for Pharmaceutical Education” as a means of improving pharmaceutical education and raising it to a more advanced level to meet changing health care needs in Japan. It has yet to be evaluated in detail. In the present study, we compared the curriculum in use at Showa University with the American style Pharm D pharmacy education program that has been implemented in Oregon State University, and noted the differences. We also conducted student surveys at 4 universities in the United States and Japan to ascertain their images of being a pharmacist and the content of the curriculums, and compared them between the two countries in order to identify problems and areas that need improvement. Another aim of the surveys was to evaluate the practicality of the new Model Core Curriculum. Some of the major points of comparison between the curriculums in Japan and America were learning objectives, educational strategies and student evaluations. Particular features of the American system were group discussions among students for the purpose of solving clinical problems and practical training sessions from the early stages to help students learn about the role of the pharmacist and importance of good teamwork with other medical staff step by step. A total of 729 people took part in our questionnaire and their responses revealed that more American students than Japanese students were satisfied with their pharmaceutical education and felt that they were acquiring skills that would be useful to them after graduation. Thus, for the new model curriculum in Japan to be most effective, both faculty and students must fully understand its educational goals and appreciate the importance of simulating clinical situations in curriculum. Further, in their evaluations of students, lecturers must give them feedback that enables them to realize the degree of progress they have made towards curriculum goals.
Acetylcysteine is used for the prevention of radiocontrast-induced reductions in renal function. However, as an oral solution, acetylcysteine has an unpleasant taste and smell, which can cause discomfort to patients. To solve this problem, we prepared an oral jelly of acetylcysteine consisting of acetylcysteine, gelatin, flavoring agent and purified water. The unpleasant taste and smell of acetylcysteine were greatly reduced through the use of flavoring agents like apple. We expect our acetylcysteine jelly to be a highly effective preparation for the prevention of radiocontrast-induced reductions in renal function.
To ensure the proper use of pharmaceutical products, it is important to check outpatient prescriptions brought by patients when they are hospitalized. In recent few years, with the introduction of the Diagnosis Procedure Combination (DPC) into the medical service fee system, patient's hospital days have been reduced. As this makes it necessary to schedule operations soon after admission, it is essential that pharmacists check prescription drugs, over-the-counter drugs and supplements brought to hospital by patients as soon as possible after hospitalization. For this purpose, we have established a convenient checking system under which the supervising pharmacist allocates patients to the respective pharmacists in charge of each ward in the morning of the day of admission. Each pharmacist interviews one or two patients to check their medicines between 2 and 5 p.m. when they can fit this in with their normal work. The advantage of this system is that it makes it easier to collect more precise information on patients through interviews and checking their medicines at the bedside. It also enables us to provide better advice to both patients and ward staff. Our system has contributed to raising the safety of patient treatment. Until now, several operations have been suspended because patients were taking anti-coagulation drugs and cases like this show the great importance of checking patient medications before hospitalization. Under the DPC system, the use of outpatient prescriptions during hospitalization has contributed to reducing hospital expenditure and our checking system has helped ensure that this is done safely.
When concentrated medical fluids are injected from the Y-site during infusions by such means as the intravenous push or piggyback techniques, drugs occasionally separate out due to their incompatibility. A technique called “flushing” is used to prevent this from happening. This involves the injection of a washing solution, such as physiological saline or glucose solution, from the Y-site before and/or after injection. However, no standards have been established for the use of this technique. To ascertain the most efficient flushing conditions, we studied the relationship among the amount of residual drug in the intravenous tubing, and the volume and rate of flow of the flushing solution (physiological saline) injected from the Ysite with an injectable furosemide (Lasix® Injection). The results showed that the volume of physiological saline required to prevent drug incompatibility by flushing out the intravenous tubing was five to six times the inner volume of intravenous tubing, but the flushing rate did not have any effect on flushing.
There are more than 600 towns/villages without pharmacies in Japan. We carried out a questionnaire survey in 131 of those towns/villages to find out how pharmacists should respond to this issue. The questionnaire showed that all of the towns/villages had hospitals or clinics and advanced home visit medical care was available in more than 80% of them. About 70% of the towns/villages considered that the lack of pharmacies was not inconvenient while 30% found it to be inconvenient. Next, to find out whether residents really had a proper understanding of the roles of pharmacies and pharmacists, they were shown a material entitled “Explanation of the Function of Pharmacies and the Role of Pharmacists”, and asked to complete a questionnaire again. This time, the questionnaire revealed that a total of more than 70% of the town and village residents surveyed thought that both pharmacies and pharmacists were necessary to the community or wished to have them in the future. These results show the strong desire for pharmacies and pharmacists in the community and also suggest that people need to be better informed of the role of pharmacies and the work of pharmacists.
In the Chukyo Hospital, two separate records of patient information had been kept by doctors and nurses and pharmacists in the past. Doctors and nurses had written it in medical records and pharmacists in pharmaceutical care records and patient compliance instruction records. These records have been unified recently and we carried out a questionnaire survey to see if doing this had been beneficial or not. Persons responding were 10 doctors (in neurosurgery and neurology) and 25 nurses The questionnaire revealed that the unified records had made patient information more accessible and shareable and had made it easier to view medication history at a glance. On the other hand, the greater amount of data and thicker files resulting from the unification were seen as a problem. However, overall, the unification of the medical records, pharmaceutical care records and patient compliance instruction records was seen as useful.
Very little quality information is available for generic pharmaceutical preparations and this is particularly so for injectable preparations for which few quality studies have been conducted. With this in mind, we conducted an inter-lot quality variation investigation on nafamostat mesilate preparations for both the original and generic products and compared the results. The investigation involved measuring amounts of impurities other than those of the active ingredient by high performance liquid chromatography. For the nine generic products investigated, impurity amounts were about 2.4 times that of the original (min. 2.0 times-max. 3.1 times). We determined that these differences were not due to hydrolysates of the active ingredient but to unknown substances since the amounts of these unknown substances in the generic products were about 5.7 times (min. 4.7 times-max. 8.0 times) their amount in the original product. Concerning inter-lot variation (maximum value-minimum value), we found that the variation in total impurity amounts for the generic products was 1.8 times (min. 0.7 times-max. 2.8 times) that of the original product, while the variation in unknown substance amounts for the generics was 3.1 times (min. 1.0 times-max.4.6 times) that for the original. The results of the present study suggest that it is necessary to take inter-lot variation into account in evaluating the quality of generic products. They also suggest that the higher contents of unknown impurities in the generics could be a cause of the in-circuit precipitation which has been reported with generic versions of nafamostat mesilate during blood purification in the clinical setting.
Adverse drug reactions cause increases in medical care expenditure. To investigate this, we estimated the annual cost of the treatment of serious drug-induced dermopathy based a report by the Ministry of Health Labour and Welfare (MHLW).We used the “relief system for sufferers of adverse drug reactions” and “Diagnosis Procedure Combination” to calculate the cost of treating each patient for serious drug-induced dermopathy, which worked out at 337, 470 yen/patient. In fiscal 2000, 302 cases of serious drug-induced dermopathy were reported so the total cost of treating this condition was estimated at 101, 915, 940 yen. This result shows that the economic cost of treating adverse drug reactions is very large.
Owing to their narrow therapeutic range, most antiarrhythmic agents require Therapeutic Drug Monitoring (TDM). Though TDM is an effective tool for adjusting the individual dosage to the optimum level, no study has shown that TDM is useful for dose adjustment in the case of cibenzoline. The aim of this study was thus to evaluate the usefulness of TDM in cibenzoline therapy. In the National Cardiovascular Center, TDM was introduced for cibenzoline in 1998. This resulted in reductions in mean serum concentrations and mean doses, and very few adverse effects have been reported. Thanks to dosage adjustment based on TDM, there was a decrease in the proportion of patients having serum concentrations of above 400 ng/mL from 2000 onwards. These results suggest that TDM is an effective tool for preventing cibenzoline toxicity and that it helps to ensure that cibenzoline is administered properly.
Patients with trigeminal neuralgia are usually treated with carbamazepine (CBZ) at the Pain Clinic in NTT East Corporation's Kanto Medical Center but some of them complain of dizziness and unsteadiness, and may even collapse. While therapeutic drug monitoring (TDM) for CBZ is covered by Government Health Insurance in the case of epilepsy, it is not covered for trigeminal neuralgia. The dosage regimen for CBZ has therefore usually been determined based on the physician's experience of patients with trigeminal neuralgia. In addition, since trigeminal neuralgia usually develops between the ages of 50 and 60, the age of patients must also be considered in determining the dosage regimen. In the present study, we investigated the relationship between the dose and status of dizziness and unsteadiness, i.e. whether patients experienced dizziness and/or unsteadiness, and the degree of any dizziness and unsteadiness that developed. We then predicted steady-state maximum plasma CBZ levels for the patients by means of a population-based pharmacokinetics calculation for clearance using their age and body weight (predicted maximum plasma CBZ level hereafter). We also statistically investigated the relationship among dose per body weight, dose per area of body surface and the predicted maximum plasma CBZ level and status of dizziness and unsteadiness. Multivariate analysis showed that the degree of dizziness and unsteadiness was significantly related to the predicted plasma CBZ level and discriminant analysis that the dosage should be set so such that the predicted plasma CBZ level is less than 11 mg/L (p< 0.032, sensitivity =70%, specificity=76%). Thus our method of predicting plasma CBZ levels could be used to determine safer dosages of CBZ when TDM is not performed.