To improve the functionality and utility of incident analysis, we developed cPHARM-2E, a computerized incident analysis system. The new system was designed to electronically link the procedures of data collection, data analysis, identification of causative factors in medical errors, determination of specific preventive measures, and periodic follow up concerning implementation of the preventive measures. A comparison of the results of incident analysis for three semi-annual periods before and after the introduction of the cPHARM-2E analysis system showed that switching to the new system (1) doubled the total number of incidents reported, (2) reduced the number of high risk incidents by half, (3) tripled the number of preventive measures proposed, and (4) increased the number and percentage of proposed preventive measures that were completely implemented by tenfold and threefold, respectively. Our findings indicated that cPHARM-2E is a user-friendly incident analysis system that will contribute to the improvement of medical risk management and medical accident prevention programs.
Nausea and vomiting are two of the most unpleasant adverse effects associated with the use of antineoplastic agents and many patients regard them as the most stressful aspect of their disease, more stressful than even than the prospect of dying. Cisplatin, one such agent, is well known for having an emetic potential of almost 100% when administered to patients without emesis prophylaxis. The nausea it causes is the delayed-type and is hard to suppress completely with 5-HT3 antagonists. Dexamethasone (DEX) is often an effective antiemetic for cisplatin-induced nausea and vomiting, either by itself or in combination with other antiemetics. Though patients were receiving cisplatin under our regimen it did not include DEX. We therefore investigated the effects of DEX in patients with uterine cervix cancer who were being treated with a regimen including cisplatin. DEX reduced the degree of nausea and frequency of vomiting and increased appetite. It also improved the cost-effectiveness of the regimen. Based on these results, gynecologists in our hospital decided to include DEX in the cisplatin regimen. We feel that DEX should be the antiemetic drug of choice for cisplatin-regimens and in future, drug regimens should be specifically designed for each patient depending on the cause of nausea and vomiting, and the available evidence.
We conducted a statistical investigation in which we compared the drug consumption in a new hospice ward with that in other wards. In order to protect the personal information of patients, we used drug consumption data that did not identify individual patients. The results of the comparison showed how the inventory control of each drug could be optimized. They also revealed that the SSRI consumption pattern in the hospice ward was the most distinctive indicating that drugs being used for the management of symptoms with such patterns could be readily determined. We considered the statistical methods used in our investigation would be effective for inventory control in new wards and departments established in hospitals.
In the present study, we investigated the acquisition of skill in the self-administration of insulin (by insulin pens) among 79 diabetes outpatients at Ehime University School of Medicine in order to evaluate the influence of such skill on glycemic control. The degree of skill acquisition by patients with poor glycemic control (HbA1C≥8.0) was significantly (p<0.05) lower than that by those with good control (HbA1C<8.0), and patients who had continuously used insulin pens over a 3-year period had higher rates of incorrect usage. In addition, the mean HbA1C of patients who kept the needle of the insulin pen pointing downwards for a certain period of time was significantly (p<0.05) lower than that for those who held the needle downwards for less than this period of time. However, HbA1C was not affected by skill in draining needles after pointing insulin pens downwards, knowledge of product name or injection units, shaking, or priming. These results indicated that the precise acquisition of skill in the self-administration of insulin is necessary to achieve good glycemic control and that keeping the needle pointing downwards for a sufficient period of time is the most important factor in the self-administration procedure. They also suggested that medical staff should keep a check on the skill of patients in the self-administration of insulin and repeatedly provide instruction on this to patients.
We evaluated the quality of the branded product (two presentations : 5 and 10 mg) and generic versions (nine products : one of them 5 mg and the other eight 10 mg) of arotinolol hydrochloride through dissolution, purity, content, and content uniformity tests. The results of an estimation of dissolution characteristics based on the quality reevaluation procedure showed that the dissolution characteristics of six products differed from those at the time of the quality reevaluation. Furthermore, differences in dissolution characteristics between production lots were observed for two products, suggesting that there may be products showing variation in quality on the market. However, our results showed that none of the products had quality—related problems as regards content and content uniformity for individual tablets or entire lots. They further indicated that the purity of seven generic products was equal to or higher than that of the branded product. Based on a comprehensive evaluation of the quality parameters we selected, the quality of one generic product was equal to or higher than that of the branded product.
We examined the relationship between bleeding time and anti-platelet medicines prescribed to 472 ischemic heart disease patients in Gifu Prefectural Gifu Hospital. The average bleeding time of the patients taking aspirin (81-200 mg) and ticlopidine (100-200 mg) concomitantly was significantly longer than that of those in the control group, while that for patients taking aspirin alone or cilostazol (100-200 mg) and aspirin concomitantly was not significantly different from that of control. There was no significant correlation between the dosage (mg/kg) of each medicine and the bleeding time. In 14 patients, the bleeding time was not prolonged when the administration of platelet medicines was started or additional antiplatelet medicines were given. The presence of patients who did not respond to anti-platelet medicines, and the difficulty of achieving reproducibility in measured bleeding times might have lead to the absence of a significant correlation between the dosage of medicines and the bleeding time. Our findings therefore suggest that it may be difficult to evaluate the effectiveness of adjusting dosages of anti-platelet medicines from the bleeding time.
In the present study, we retrospectively evaluated the efficacy and safety of pravastatin sodium after switching from the branded product to a generic. Our subjects were 27 type II diabetes mellitus patients aged 52-87 years with hyperlipidemia as a complication, who received the branded product for 12 weeks and were followed up for more than 12 weeks after switching to the generic product. No significant differences were noted between the branded and generic products as regards serum lipids, creatine phosphokinase (measured in 6 patients), or biochemical parameters of hepatic and renal function. We may therefore conclude that the branded and generic pravastatin administered in this study had similar efficacy and safety profiles.
We conducted a questionnaire survey on postoperative pain, and the pain-relieving effect of loxoprofen sodium (loxoprofen) in outpatients following dental surgery in order to improve pain relief and explanation to patients concerning this drug. The questionnaire was given to patients who took loxoprofen after a dental surgery between October 2002 and February 2003 and the recovery rate was 67%. We analyzed the degree of pain after surgery, the time of taking loxoprofen, and the pain-relieving effect of loxoprofen. The pain-relieving effect was manifested within 60 minutes in 91% of patients and 69% of patients noted a definite reduction in pain. Patients in whom extractions were difficult to perform and those who had surgery other than extractions had a longer duration of pain than those who had extractions that were easy to carry out, and the frequency of taking loxoprofen was particularly high for those who had high pain manifestation rates and long duration of pain. Also, patients whose surgery time was longer experienced more intense postoperative pain. However, pain was relieved effectively when loxoprofen was taken immediately after a difficult extraction. From the questionnaire survey, we were able to obtain useful information on the severity of pain and adequate doses of loxoprofen for relief of pain following dental surgery. We used this information to improve our explanation of the use of loxoprofen to patients.
We developed a novel support system for more effective and safer cancer chemotherapy, whose major aims were to improve pharmaceutical care by reinforcing prescription checking, providing higher quality medical information and standardizing guidance for cancer patients. Protocols consisting of the dosages, dosing schedules and adverse reactions of anticancer drugs and procedures for their admixture were the key element of our support system. Prescription checking parameters included patient height, weight, body surface area, type of cancer diagnosed, dosage and dosing schedules. For patients who had received the same protocol for the same type of cancer previously, the dosage was checked using past dosage data, laboratory data and adverse effect information. In order to standardize guidance given to patients, we had the system automatically produce adverse effect monitoring and check sheets and used this information together with that obtained from patients to prepare information that would aid consultation. This helped avoid adverse events and ensure that anticancer jobs were used properly, which made cancer chemotherapy more effective and safer. The support system enabled valuable information on cancer chemotherapy to be provided to doctors, nurses and pharmacists. We therefore consider it to be a useful tool in chemotherapy for cancer patients.
We conducted a prospective investigation using the visual analog scale (VAS) method to evaluate the pharmacy experience and lectures of the Division of Pharmacy and Health Sciences, Graduate School of Natural Science and Technology, Kanazawa University. The students were instructed to evaluate their understanding and attainment of the pharmacy experience and lectures. The preceptors then evaluated the students in their charge based on their understanding and attainment of the pharmacy experience. Comparisons before and after the pharmacy experience and for each student-preceptor pair were performed with the aim of solving problems encountered, if any, for improvement. For most of the cases, scores of, self-evaluation by the students for after the pharmacy experience were higher than those for before, indicating that the pharmacy practice had been effective. The student-preceptor comparison showed that the students gave themselves higher scores for understanding and the preceptors gave their students higher scores for skills. This shows that the students felt that they had gained much knowledge of pharmacy but thought that they needed further training to improve their practical skills. In the self-evaluations after the course of lectures but prior to the pharmacy practice, the overall degree of understanding was 60%, however, this decreased after the pharmacy experience. Thus, the students were not able to retain the knowledge gained during the lectures until the end of the pharmacy experience, suggesting a need to review the content of the lectures and to rearrange schedules.
The results of a population pharmacokinetic (PPK) analysis for Japanese suggest that smoking and gender difference are factors influencing the clearance of olanzapine, an atypical antipsychotic drug. However, no post-marketing verification has been conducted regarding how these factors affect the prescribing of this drug by practicing physicians. We therefore conducted a retrospective analysis on the effects of smoking and gender difference on olanzapine dosages. The results showed that smokers received significantly higher doses of olanzapine than non-smokers and that males tended to receive higher doses of olanzapine than females. The dosage for male smokers, the highest dose group, was 1.3 times that for female non-smokers, the lowest dose group. These results showed good correspondence with those of the PPK analysis given in the package insert and suggests that PPK data could be useful information for the community pharmacist.
There is a tendency for cancer chemotherapy to be switched from an in-patient to an outpatient basis for various reasons, among them development of support treatments, improvement of patient QOL and constraints on medical expenditure. Our subcommittee discussed various situations of pharmaceutical care in outpatient chemotherapy and based on the results, we prepared highly practical chemotherapy work sheets for medical staff. The content of the sheets consisted of information that we had gathered on typical cancer chemotherapy protocols that we discussed. Such information was collected while the patients were still in hospital and put to good use when they were switched to outpatient chemotherapy. It included pharmaceutical information regarding protocols such as recommended dosage, dosage schedule, precautions before administration and adverse effects. The present paper describes the use of our worksheets in EC therapy for breast cancer. Our sheets may be used in any period of treatment to monitor important items. If doctors, nurses and pharmacists all use the sheets, pharmaceutical care may be standardized and such standardization will help ensure that antineoplastic agents are used properly and safely.
The aim of this study was to assess the awareness of pharmacists, pharmacy students and researchers regarding “Drugs and Pregnancy”. In order to do this, a questionnaire was given to 211 attendees of a symposium held under a pharmacists' education program held at the University of Tokushima. The response rate was 108/211 (51%) and the breakdown of the respondents was students 46%, pharmacists 36% and researchers 9%. Among the 36 persons with experience of delivery, 67% had taken medicine during pregnancy, and 42% of them were worried about the embryotoxic effects of drugs. Persons with no experience of delivery were more worried about such effects than those who had experienced delivery. Before being given a prescription, 71% of the respondents had been asked about the possibility of pregnancy by a physician. On the other hand, no respondent had been asked about this by a pharmacist, suggesting that pharmacists are passive with regard to providing information about drugs and pregnancy. Information on drugs and pregnancy was mainly obtained from drug package inserts, books and pharmaceutical companies. The majority of the respondents (96%) were interested in a web site from which they could retrieve information on drug safety during pregnancy. They showed a willingness to cooperate with regard to recording medicines used during the pregnancy as well as the outcome of their pregnancies. Eighty-nine percent of the researchers and 78% of the students wanted to use teratogenicity information in drug design. All of the researchers answered that it was beneficial to share information on reproductive and developmental toxicity. The results of our questionnaire survey showed that many people desired drug safety information during pregnancy, and were willing to share such information.
We investigated the uniformity of content, rheological properties and chemical stability for prescription of Kindavate® ointment diluted with white petrolatum. When the ointment was levigated with white petrolatum (Propeto® for dilution) by a pharmacist or mixed by an autorotation/orbital mechanical mixer, a uniform ointment having the precise drug content could be prepared for all conditions. However, as the dilution ratio increased, the hardness of the ointment seemed to decrease based on the yield point measured with a spread meter and apparent absolute viscosity. Also, using a polarizing microscope, we observed a dispersion of oil droplets (consisting of liquid paraffin in clobetasone butyrate) in petrolatum for both Kindavate® ointment and the diluted ointment showing that the internal structure of ointment had not been affected by preparation of the diluted ointment either manually by pharmacists or using the mechanical mixer. When the diluted ointment was stored at 4 or 25°C in tight container in the absence of light, it was chemically stable for at least a month. Since our results showed that Kindavate® ointment diluted with petrolatum had a precise drug content and was stable over time, it should be feasible to prepare the ointment in advance of use.