One of the main roles of the hospital pharmacist is the practice of pharmaceutical care. In this study, we investigated whether the average number of drugs, drug costs and the incidence of adverse effects were reduced by the presence of a pharmacist in the neurology ward of Nagoya Daini Red Cross Hospital and also considered the future role of the hospital pharmacist. Previously, the main focus of pharmaceutical care was to improve patient compliance but it is now felt that the duties of a hospital pharmacist should not be limited to medication counseling. They should be involved in all aspects of drug therapy and play a central role in risk management. Pharmaceutical care involves a process by which pharmacists cooperate with each other to ensure the safety and effectiveness of a patient's drug therapy. It was found that the duties of the clinical pharmacist increased yearly from 2000 to 2003 and were extremely varied so it is now vital that they have a high level of knowledge in their field. It was also noted that the presence of a pharmacist in the ward substantially reduced the number of drugs prescribed as well as drug costs and the incidence of adverse effects due to multiple drug therapy. As members of a multidisciplinary care team, pharmacists now have to be responsible for the safety and effectiveness of medications and for all aspects of a patient's drug therapy. Thus their role is no longer limited to the narrow definition of clinical pharmacy practice which only involves medication counseling.
The stability of OPALMON® tablets under humid conditions was improved in a previous study through the use of a better formulation. In the present study, we tested the improved formulation (improved OPALMON® tablets) for purity, content, disintegration time, and tablet hardness. The improved OPALMON® tablets contain a lyophilized form of limaprost alfadex and dextran with dextrin. The stability of the existing formulation of the OPALMON® tablets and improved OPALMON® tablets was compared under humid conditions either by placing tablets in a Petri dish or putting them in a one-dose package which consisted of glassine and cellophane paper. The percentage degradation of the improved OPALMON® tablets was approximately 20% of that of the existing formulation. In the one-dose package, the purity of the improved formulation met the acceptance criteria for four months at 25°C and 60% relative humidity (RH), and eight weeks at 25°C and 75% RH. In the one-dose package, the content and disintegration time of the improved formulation also met the acceptance criteria for four months at 25°C and 60% RH, and eight weeks at 25°C and 75% RH. However, there was a slight reduction in tablet hardness for the improved formulation after one month at 25°C and 60% RH, and one week at 25°C and 75% RH. On evaluating the strength of the tablets at the time of packaging through a packaging test using a fully automated tablet packer, there were no broken or chipped tablets in either the initial samples or samples with reduced hardness. We therefore concluded that the hardness of the improved OPALMON® tablets is satisfactory for our purposes.
Eighty-one prescription drugs were divided into three groups according to the strength of the auto-correlation (strong, weak or none) of daily variations in the drug supply amounts at a pharmacy. The power spectral density and auto-correlation function were used as an indicator for the classification. Sixty-four drugs fell into the no auto-correlation group, 15 drugs into the weak auto-correlation group and 2 drugs into the strong auto-correlation group. Interestingly, our grouping using auto-correlation as a criterion was consistent with the target-oriented classification (standard commodity classification of Japan).
In Japan, the health insurance regulations state that it is necessary to start the administration of G-CSF for neutropenia caused by cancer chemotherapy after the neutropenia has appeared. Under these regulations however, in the case of malignant lymphoma, we can start to administer G-CSF at any time, except in the 24 hours before and after the chemotherapy. In the present study on malignant lymphoma, we found that it was more effective to administer G-CSF for the purpose of increasing the nadir of neutrophil counts early on rather than waiting for the appearance of neutropenia before starting its administration. We also noted that interrupting the administration of G-CSF for a day reduced the nadir of neutrophil counts. Further, in patients whose neutrophil counts were less than 100/μL developed sepsis more readily than those in whom neutrophil counts were more than 100/μL. As our conclusions, in malignant lymphoma patients, the continuous administration of G-CSF from the early stage can reduce the severity of neutropenia and such patients with severe neutropenia have an increased risk of sepsis.
Japanese traditional herbal medicines (Kampo medicines) play an important role in healthcare in Japan. However, recently, adverse effects due to Kampo medicines, such as liver injury, have been reported. In order to examine the frequency of liver injury in patients taking Kampo medicines and to identify the herbs mainly responsible for liver injury, we examined ALT levels in patients before and after administration of Kampo medicines at Akiba Hospital in Sanbu-gun, Chiba Prefecture. We targeted outpatients who first came to the hospital between 1993 and 1996 and whose ALT levels before and after the administration of Kampo medicines were known. Out of the total of 305 patients, 15 patients had elevated ALT levels. Eighty-seven percent of the liver injury in these patients occurred more than 3 months after the date that Kampo medicines were first administered and the periods until it occurred varied from 2-8 months. Eleven Kampo medicine formulations were used for these patients but Scutellariae radix was the only herb given to all of them suggesting that this herb was responsible for the liver injury. Incidentally, herbal medicines containing only Scutellariae radix have previously been reported to cause liver injury. Therefore, patients treated with Kampo medicines containing Scutellariae radix should have regular blood tests at least once a month to check for any signs of liver injury.
To evaluate the quality of orodispersible famotidine tablets (15 versions of 8 preparations comprising the original product and 7 generic products), a hardness test, dropping shock test, abrasion test, and bitter taste test were conducted. Large differences were observed in the hardness, dropping shock, and abrasion tests among the preparations. In the dropping shock and abrasion tests, however, no change was observed in the appearance of some preparations but the tablet weight decreased or tablets broke into pieces with some of them. In the taste test, 4 preparations were found to be masked sufficiently against bitter taste, but 4 preparations were not. These results suggest that some of the generic products were superior in quality to the original product and some were inferior. It is therefore necessary to adequately evaluate differences in quality when selecting generic products.
Many elderly patients are fed by tube in Towa hospital and two special elderly nursing homes. Therefore the work of crushing practice for medication using feeding tubes has been increasing steadily year by year. The purpose of this study was to investigate the current crushing practice and to improve pharmacy practice efficiency through the introduction of simple suspension method that enables tablets and capsules to be administrated after dissolving or collapsing in hot water without crushing. We counted the number of prescriptions in crushing dispensing between January and December 2004 and investigated how nurse medicate in each ward. The current crushing practice hours was compared with predicted hours using simple suspension method. Furthermore, we examined the medicine that we should give information about when we use the method. The following results were obtained. The crushing dispensing percentage of all prescriptions was 13.0%. That breakdown was 43.5% for recuperation facilities, 30.4% for two special elderly nursing homes, and 26.1% for general wards. We predicted that the simple suspension method would reduce the monthly dispensing time from 43.2 hours required for crushing to 11.3 hours. The medication by nurse varied between wards. In addition to listing the 49 medicines that was impossible to administer using feeding tubes, we made an information card on Sennoside as medicine used most often that need to be changed in prescription. These results suggest that the introduction of simple suspension method enable to conduct more efficient and effective pharmacy practice.
In order to evaluate generic versions of famotidine, 11 kinds of famotidine tablets and 7 kinds of famotidine injection (both tablets and injection included the branded product, respectively) were subjected to dissolution testing and HPLC analysis. In the case of tablets, both the branded drug (Gaster®) and the 10 generics satisfied the standard dissolution test requirement that more than 70% of tablets should dissolve within 60 min, though there were significant differences in the time taken to achieve more than 70% dissolution. In this respect, some of the generics were quite different from the branded drug. As for the famotidine injection-formulations, both the branded drug, (Gaster® injection) and the 6 generics satisfied the standard for the content test in JP XIV. However, HPLC analysis showed that generic formulations contained a variety of impurities while the branded injection (Gaster® for injection 20 mg) contained very few impurities. In three of the generic injection-formulations-Famostagine® for injection 20 mg, Progogue® for injection 20 mg and Gasport® for injection 20 mg —the contents of impurities were significantly different from that of Gaster® for injection 20 mg. The present study showed that there were appreciable quality differences between the branded and generic versions of famotidine irrespective of formulation.
A large amount of drug information is now available on the internet and patients' needs for drug information are becoming greater, especially with regard to adverse drug reactions, efficacy and drug interactions (DIs). However, it is difficult for patients to learn about all possible drug interactions for the drugs that they have been prescribed. With this in mind, we developed a drug-drug and drug-food/drink interaction appraisal system for individual prescriptions utilizing web access functions embedded in mobile phones. The database on DIs was developed using Microsoft® Access 2003. Three database master files were created : “Prescription Drug Substance Master”, “Prescription Drug Brand Name Master”, and “Drug Interaction Master”. Excepting Prescription Drug Substance Master, the master files were sent to a server configured using Linux OS, MySQL, Apache®, and Hypertext Preprocessor (PHP). The database contains detailed information on 281 DIs, and 1064 entries for drug brand names and foods/drinks. It may be accessed from mobile phones, and its web pages were designed to be compatible with mobile phone operations. Through the use of the present DI appraisal system, it is possible to easily retrieve information on drug-drug or drug-food/drinks interactions using drug brand names. When entering data and updating the system, the people who maintain the database are able to not only input specific drug names but also pharmacological classifications for defining DIs. Furthermore, information on DIs is provided using comprehensive terms to make it easy for the general public to understand. In conclusion, by providing comprehensive information on DIs, the present DI appraisal system based on mobile phone access should raise patient awareness of DIs and can help to avoid them.
A standardized system for the entire hospital is required for the rational use of anti-MRSA drugs, and all clinical staff should have a common understanding of it. With this in mind, we introduced a clinical pathway (CP) for anti-MRSA drug TDM analysis, aiming at both standardization and efficiency improvement throughout our hospital. Under the standardized system, initial dosages were set for all anti-MRSA drugs and for all the patients to whom they are administered. Then, after the system had been introduced, we evaluated its influence on treatment efficiency. The number of requests for initial dosage setting submitted before prescription was only 2.5% without the CP (TDM group) but this increased to 35.0% after the introduction of the CP (TDM-PATH group). Further, mistakes in the timing of blood sampling decreased from 9 cases in the TDM group to 6 cases in the TDM-PATH group and the rate of applying initial dosage settings increased from 10.0% in the TDM group to 22.5% in the TDM-PATH group. In addition, the rate of conducting TDM analysis after setting the initial dosage increased from 55.0% in the TDM group to 72.5% in the TDM-PATH group. There was no instance of not setting initial dosages in the TDM-PATH group. In the first blood sampling, the standard blood concentration for the TDM group was established at 77.3% and at 82.8% for the TDM-PATH group. In the evaluation of the therapeutic effect, the efficiency was 43.5% in the Non-TDM group, 80.0% in the TDM group, and 75.8% in the TDM-PATH group showing a significant improvement both in the TDM group (p<0.01) and in the TDM-PATH group (p<0.001) (χ2-test).
Aspirin has an anti-platelet effect, and is being widely used for the prevention and treatment of thrombosis. Despite the benefits of aspirin in preventing thrombus, however, gastrointestinal complications often occur as an adverse effect and though many studies on the gastrointestinal complications due to high-dose aspirin have been conducted, there have been few studies on gastrointestinal complications due to low-dose aspirin. This paper describes the results of research on gastrointestinal complications due to low-dose aspirin conducted at a health insurance pharmacy. The prescribing frequencies of low-dose aspirin, antisecretory drugs (H2 receptor antagonists and proton pump inhibitors) at the health insurance pharmacy were calculated and then the prescription data was further classified according to concomitant use of low-dose aspirin products with antisecretory drugs, and the odds ratio of concomitant use was estimated. During the period from April, 2003 to March, 2004 the odds ratio of concomitant use of aspirin with antisecretory drugs was 2.07 (95% CI, 1.03-4.14). In this study, no patient was found to be taking antisecretory drugs concomitantly with aspirin and thus antisecretory drugs were not being used to prevent the gastrointestinal complications of aspirin. Our findings suggest that the risk of the gastrointestinal complications could be increased by taking low-dose aspirin over the long term.
Patients were followed up for serum lipid levels after we changed their prescriptions from pravastatin to atorvastatin at our hospital. There was no significant decrease in the serum lipid levels of 17 patients who completed the follow up period on atorvastatin. However, replacing pravastatin with atorvastatin lowered total cholesterol (TC) levels from 260.9 mg/dL, a decrease of about 20% and a significant difference (p<0.0001). LDL-cholesterol (LDL-C) levels dropped from 162.1 mg/dL to 122.5 mg/dL, about 29% less and also a significant difference (p<0.0001). Triglycerides (TG) were lowered from 162.2 mg to 115.5 mg/dL, also about 29% less and again a significant difference (p<0.005). There was also a significant drop in HDL-cholesterol (HDL-C) from 66.3 mg/dL to 63.5 mg/dL (p<0.005) but this was in the normal range. Atorvastatin seemed to be effective for treating patients in whom pravastatin had been considered ineffective. Further, since atorvastatin should be good at lowering TG levels, it may be effective when used selectively in treating patients with high levels of both LDL-C and TG.
The Clinical Trial Management Center in Kyushu University Hospital was originally established in April 1999 and was later reorganized to form the Clinical Research Center in October 2003 due to the expansion of support activities for clinical trials. In pace with this, the number of clinical research coordinators (CRCs) increased from 2 in 1999 to 13 in 2005. To improve the performance of clinical research for physicians, CRCs and secretariats, we conducted a questionnaire survey of sponsors of clinical trials (pharmaceutical company staff) to see how they evaluated the work done by our Clinical Research Center. The questionnaire consisted of 10 items regarding our overall conduct of trial practice for which scores were obtained anonymously. We sent the questionnaire to 116 sponsor staff and received replies from 101 of them, a recovery of rate of 87%. The sponsors were generally satisfied with the conduct of clinical research at our Center, but were not fully satisfied regarding a few items which included the payment system for trial expenses, physicians' awareness, and recruitment of subjects by CRCs. Based on the results, we have recently introduced a new education system designed to increase physicians' motivation. Under this system, the conduct of clinical trials is limited to physicians who receive regular lectures on clinical research and are certified by our Clinical Research Center.
We describe a pharmaceutical care plan for liver cancer patients based on pharmaceutical management methods. There is a checklist for the major points of the plan and by using it, we were able to identify the pharmaceutical problems and conduct interventions to solve them. We evaluated the clinical efficacy of the pharmaceutical care plan. Our subjects were liver cancer patients who were hospitalized in the Department of Gastroenterology from March to October, 2004. The pharmaceutical care plan was implemented in the last four months of this period and a comparison was made between a group of patients in whom its interventions were applied and a control group. In our study, we evaluated the pharmaceutical problems, pharmacist interventions, and the number of times patients receive guidance. The checklist suggested that pharmacist interventions be conducted for specific problems and included guidance for treatment from the time of admission to discharge. The control group comprised 30 patients (7 females, 23 males ; mean age, 70 years), and the intervention group comprised 48 patients (8 females, 40 males ; mean age, 68 years). As compared with the control group, there was a 2.9-fold increase in the total number of pharmaceutical problems addressed in the intervention group and there was a 2.8-fold increase in the total number of pharmacist interventions, both of these differences being significant. In the intervention group there was a 1.2- fold increase in the number of times patients received guidance over the control group but this difference was not significant. Based on these results, the pharmaceutical care plan is considered to be effective for improving the quality of patient care and pharmaceutical care for liver cancer patients.
A 57 year-old male patient with rectal cancer was operated on and then a colostoma was constructed. Oral therapy with diclofenac (75 mg/day) for relief of pain due to the primary cancer invasion and thoracic vertebrae metastasis had to be discontinued due to worsening difficulty in oral ingestion. Also due to the increasing severity of cancer-related pain in the buttocks and the back, infusion of fentanyl was initiated due to morphine intolerance, and was effective for pain relief for the former, but not in the latter, at 1.056 mg/day. Thus, therapy with diclofenac suppositories was initiated via his colostoma based on informed consent, since his anus was not available for this purpose due to the rectal surgery. Based upon the patient's own pain evaluation, the back pain was well controlled by the intracolostomal administration of diclofenac suppositories at a dose of 75 mg/day, although plasma concentrations of diclofenac were approximately 50% of those achieved with intracolostomal administration in another study. Though we can not clearly say why the intracolostomal administration of diclofenac suppositories was effective in spite of the low plasma concentrations of the drug, the combination of diclofenac and fentanyl may have produced a good analgesic action. The adminisration of Diclofenac via the colostoma was continued over 6 months, and there were no particular problems. These findings suggest that a colostoma is a useful alternative route for suppositories, when the rectum is unavailable.