Currently, normal saline lock or normal saline containing heparin lock are routinely used after IVH or intermittent peripheral infusion in the clinical setting. Up till now, however, there has been no evidence for the optimal concentration of heparin in the lock solution for preventing thrombus formation in peripheral vein catheters and central venous catheters. The purpose of this study was to evaluate the effectiveness of normal saline against normal saline containing 10 U/mL or 100 U/mL heparin for preventing blood clotting in peripheral vein catheters. Patients (N=60) in Kanazawa University Hospital were randomized to 3 groups (saline lock group, 10 U/mL heparin lock group and 100 U/mL heparin lock group : N=20 for each). We evaluated the rates of thrombus formation and thrombus protein content after 24 hours of lock in peripheral vein catheters. Our results indicated that when the 100 U/mL heparin lock solution was used, both thrombus formation rates catheters and protein contents were significantly lower than for the other 2 groups. However, at 100 U/mL, the heparin lock solution caused most pain at the insertion site, though the reason for this was not clearly known. In conclusion, as compared with the normal saline solution and the 10 U/mL heparin lock solution, the 100 U/mL heparin lock solution was more effective in preventing the thrombus formation in the peripheral vein catheter.
We prepared a questionnaire mainly targeting the mentality of diabetic patients based on the Tokyo University Egogram (TEG) which is used as a means of evaluating personality characteristics. It was given to 125 outpatients and at the same time patient levels of HbA1c an indicator of blood glucose level control, were measured to see if there was a connection between blood glucose level control and patients' attitudes to treatment (degree of acceptance of the treatment). HbA1c was also measured at 3 months and 6 months afterwards. In the TEG results, the NP (nursing patient) value tended to be high and the AC (adapted child) value tended to be low. The mean level of HbA1c at the time of the survey was 7.10±1.21%. In trying to understand the characteristics of each diabetic patient, we found it important to gauge how each patient felt about the TEG scale, their degree of acceptance of treatment, awareness of self-control and feeling about low blood glucose levels.
Information concerning recalls of products derived from particular biological sources has been provided in the “Recall Information” section of a website containing information on drugs and medical equipment since July, 2003. However, considering that “products derived from particular biological sources” have mostly been recovered when the information is presented on the website, the quantity of the products for recovery is likely to be substantial based on “State of Progression of Retrospective Investigations of Blood Donors”, and that the Red Cross of Japan has provided 24,019 pieces of information to medical organizations in connection with retrospective investigations, recall information concerning “products derived from particular biological sources” differs from that for other products in that its presentation is restricted. However, the situation has been markedly influenced by the following regulations. 1. The possibility of retrospective investigation was increased by Article 68-9 of the Pharmaceutical Affairs Law enforced on July 30, 2003 : “Preparation and retention of records on biological products”.2) 2. The “Exhaustive review of blood donation histories of blood donors”3) stipulated that information must be provided to medical organizations, and the products in question must be recovered if they have not been used. In this study, the usefulness of retrospective investigation of recall information of “products derived from particular biological sources” was evaluated. The results suggest that, in evaluating “recall information”, it is necessary to investigate the total number of products to be recalled and the background of the recalls, and also to consider regulations other than the recall regulations applied to individual drugs.
We introduced a pharmaceutical care plan based on pharmaceutical management methods for liver cirrhosis patients. The plan included a check list of important points and through its use, we were able to pinpoint the pharmaceutical problems and conduct interventions to solve them. We evaluated its effectiveness in the clinical setting. Our subjects were liver cirrhosis patients who were hospitalized in the Department of Gastroenterology from March to October 2004. The pharmaceutical care plan was adopted in the latter four months of this period and we made a comparison between before and after introduction. We evaluated the pinpointing of pharmaceutical problems, pharmacist interventions, and the numbers of complaints of patients. The check list mentioned the pharmacist interventions conducted for the problems and included guidance for treatment from the time of admission to discharge. The before introduction of pharmaceutical care group had 30 patients (7 females and 23 males, average age 64 years), and the after introduction group had 17 patients (7 females and 10 males, average age 58 years). There was a 4.8-fold increase in the total number of pharmaceutical problems addressed for the after introduction group as compared with the before introduction group, a significant increase. Further, there was a 2.1-fold increase in the total number of pharmacist interventions in the after introduction group as compared with the before introduction group, also a significant increase. As for the number of patient complaints, there was a 1.2-fold increase in the after introduction group as compared with the before introduction group, again a significant difference. We therefore consider that our pharmaceutical care plan had been successful in improving the quality of care.
Thromboxane A2 (TXA2) is produced from arachidonic acid by cyclooxygenase-1 (COX-1) in thrombocytes and for the most part is converted to 11-dehydro-thromboxane B2 (11d-TXB2), the final stable metabolite. Daily excretion amounts of 11d-TXB2 in urine are well correlated with the extent of inhibition of COX-1 by aspirin. Since the collection of 24-hour urine that is generally used for such evaluation is a lot of work, we studied the validity of using spot urine for this purpose. The intra-day variation in urinary 11d-TXB2 levels was studied in six healthy volunteers. Urinary concentrations of 11d-TXB2 were measured using a commercial enzyme immunoassay kit. The urinary excretion rate of 11d-TXB2 was expressed as the concentration ratio of 11d-TXB2 vs. creatinine. The results showed that there was no marked variation in intra-day urinary excretion rates, the range being within of that for urine collected over 24 hours for each volunteer. However, the urinary excretion rate of 11d-TXB2 was slightly decreased at around 7 pm for almost all of the volunteers. These results indicated that spot urine could be used in place of 24-hours urine collection for evaluating 11d-TXB2 levels.
At the Niigata Pharmacy, there were 1,244 dispensing errors, consisting of 1,236 internal errors, 8 external errors and no accidents, during the year from April 2002 to March 2003. Eight-hundred-and-forty-one of the dispensing errors were safety-related, equivalent to 67.6% of all dispensing errors, and 1.6% of all prescriptions. Among the safety-related dispensing errors, 185 were adverse effect-related (14.9% of all dispensing errors) and 656 were symptom aggravation-related (52.7% of all dispensing errors). The breakdown for the safety-related errors was : about 40% for calculation errors, about 20% for dispensing omissions, about 15% for drug content errors, about 15% for dispensing other drugs in error and about 10% for other errors. The adverse effect-related errors consisted mainly of pharmaceutical mistakes, which were drug content errors, dispensing other drugs in error and dosage errors. On the other hand, symptom aggravation-related errors were mainly simple mistakes such as calculation errors and dispensing omissions. More than 90% of safety-related errors were calculation mistakes, with more than 74.6% of them being discovered at the halfway inspection and 24.5% being discovered at the final inspection. Our findings seem to indicate that pharmacists can cause a lot of risk for patients so we must make all possible efforts to reduce our mistakes and establish a double or triple check system to prevent dispensing errors.
It is often difficult for nurses to determine the content of powders that consist of several different medicines and sometimes medicines have been given to patients in error. To reduce this risk, we introduced a powder packaging machine with a printing system that produces packages with the patient's name and dosage information on them. We evaluated the introduction of the packaging machine through a questionnaire survey of nurses in general wards and parents of pediatric patients. It was found that 30% of nurses and 20% of parents had experienced medication errors due to absence of labeling on powder packages before introduction of the packaging machine and about 30% of the nurses and parents felt that the detailed labels printed by the packaging machine would prevent medication errors. The questionnaire included a section on possible invasion of privacy in the outpatient setting through the appearance of names on medicine packages and from the responses, we felt that the use of labels bearing patient names should be examined carefully to prevent this. In conclusion, we feel that the introduction of a powder packaging machine with a printing system has been beneficial to risk management and that additional improvements should be made to further reduce the risk of medication errors.
We have been conducting a four-week practical hospital training course incorporating experience-oriented programs for fourth-year undergraduate students at Ehime University Hospital. There are 17 such programs in the curriculum among them instruction in the self-administration of insulin and bronchial asthma inhalers, nutrition support, drug counseling training using case-based learning procedures and role-play practice (CBL practice), and evidence based medicine (EBM practice) based on the provision of drug information. Self-learning exercises were devised for CBL and EBM practices. At the end of the practical hospital training course, we conducted a questionnaire survey concerning understandability, extent of previous understanding, training time, necessity of each program and degree of satisfaction with it. Analysis of the responses showed that student satisfaction with the practical training program was positively and significantly correlated with understandability (r=0.756, p<0.01) and degree of experience received (r=0.538, p<0.05). However, there was no correlation between satisfaction and previous understanding, training time or necessity. These results suggest that the experience-oriented programs enhanced students' understanding of the hospital practical training and also increased their satisfaction with it.
The objectives of this study were to 1) describe Japanese pharmacists' perceptions about community pharmacy on a variety of issues and 2) compare the perceptions between different groups. A questionnaire was administered to a convenience sample of community pharmacists in the Tokyo metropolitan area and Hiroshima prefecture. Pharmacists were surveyed on various issues such as job satisfaction, the separation of prescribing and dispensing, their relationship with patients and physicians, and pharmacy education. A five-point Likert scale was used to measure responses and ranged from 1=strongly disagree to 5=strongly agree. One hundred forty-four questionnaires were completed. Eighty-four percent of respondents were female, 37.5% had more than ten years of practice experience, and 81.9% worked in Tokyo. Japanese community pharmacists are neutral or satisfied with their jobs. However, respondents were not satisfied with the current state of community pharmacy in Japan (2.81±0.83), did not feel respected by patients (2.74±0.99) and physicians (1.99±0.95), felt that four years of education was not enough to provide adequate patient care (1.96±1.01), and would like to do more clinical oriented activities (3.77±0.84). Significant differences were found in some responses between groups such as males versus females and pharmacists with more versus less than ten years of practice experience. Respondents were not satisfied with the current state of community pharmacy in Japan. Areas that could use improvement are respect from patients and physicians, involvement in clinical activities, and assistance at work. Significant differences were found in the perceptions of the groups studied.
We investigated the usefulness of a suppository containing highly concentrated glycyrrhizin monoammonium (GZ-NH4) solution prepared by pretreatment with clove oil in rats. The aims of this study were to clarify membrane permeability, the bioavailability of GZ-NH4 and the extent of tissue damage. Membrane permeability was evaluated using Ussing-type diffusion chambers, bioavailability assessed through an in vivo absorption study, tissue damage evaluated through observation of hematoxylin-eosin stained tissues and an in vitro release study was carried out to select the suppository base. The formulations used were a GZ-NH4 solution prepared using phosphate buffered solution (control), GZ-NH4 containing 50% labrasol, and GZ-NH4 pretreated with 2% clove oil at 50°C and 70°C. The GZ-NH4 concentrations of all formulations were set to 50 mg/mL. With the GZ-NH4 pretreated with 2% clove oil formulations, the apparent permeability coefficients (Papp) were 1.7- and 1.9-fold higher, respectively, than that of the control formulation. When the various formulations were applied to the rat rectum at a dose of 50 mg/kg of GZ-NH4, the bioavailability of GZ-NH4 pretreated with 2% clove oil at 70°C was 25%, the highest among the four formulations. In the in vivo absorption study, no damage to the epithelial cells of the rectum was observed. These results suggest that GZ-NH4 pretreated with 2% clove oil at 70°C is the most useful formulation for rectal administration. In the in vitro release study to select suppository base, polyethyleneglycol 1000 (PEG 1000) was selected as the hydrophilic base and Witepsol H-15 as the lipophilic base. The initial release of GZ-NH4 was highest for the Witepsol H-15 suppository base. Overall, our results suggest that a lipophilic suppository containing GZ-NH4 pretreating with 2% clove oil at 70°C has the highest release and absorption rates for GZ-NH4 in rectal administration.
The Clinical Trial Management Center of Kyushu University Hospital was originally established in April 1999 and reorganized as the Clinical Research Center in October 2003 due to the expansion of support for clinical trials and general clinical research. In pace with this, the number of full-time clinical research coordinators (CRCs) increased from 2 in 1999 to 11 in 2004. To evaluate our function as CRCs and further improve it, we surveyed the opinions of physicians who have been in charge of clinical trials by questionnaire. Although most of the physicians generally appreciated the service we provide as CRCs, several of them said that there were not enough CRCs and that we had to provide better support. In conclusion, we felt there was a need to revise the content of the support provided to physicians by CRCs in the future. Also, in order to ensure the smooth conduct of clinical trials, in addition to enhancing physicians' appreciation of clinical research, we must further improve the situation of clinical trials, for instance by introducing a new system for evaluating their performance.