XELOX (capecitabine plus oxaliplatin) is a standard treatment for unresectable advanced colorectal cancer. Combining oral and intravenous administration, it is convenient method of treatment but full patient compliance regarding capecitabine is necessary to obtain efficacy. To help ensure good patient compliance for this drug, we established a pharmaceutical outpatient clinic at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR) where pharmacists interview patients prior to physicians' assessments. Medication compliance and adverse effects are investigated, and supportive care and prescription support provided. In this study, we evaluated the usefulness of the pharmaceutical outpatient clinic. We retrospectively investigated colorectal cancer patients who had received treatment with XELOX or XELOX + bevacizumab in our hospital. The end points included the number and content of inquiries concerning XELOX and the adoption rate of suggestions made regarding supportive care. In the results, inquiries concerning XELOX were made for 5.3% (14/260) of patients in a pharmaceutical intervention group (post-pharmaceutical outpatient clinic), in contrast to 16.8% (43/256)for a control group (no consultation in pharmaceutical outpatient clinic). The number of inquiries was significantly lower in the pharmaceutical intervention group than in the control group (p<0.001). In the pharmaceutical intervention group there were no inquiries about dosage. At 95.4%, the adoption rate for 592 prescription suggestions was very high. The results of our study indicate that the pharmaceutical outpatient clinic was useful for patients prescribed XELOX.
There are now many medicines for which pharmacists should monitor efficacy and adverse effects so, when necessary, they have to check the vital signs of patients directly in a physical assessment. We established a systematic training course on physical assessment for pharmacists and pharmacy students in Nagasaki Prefecture because there had not been one before, and evaluated its effectiveness. First of all, we established the Nagasaki Society of Physical Assessment for Pharmacists. Second, we set out General Instructional Objectives (GIOs) and Specific Behavioral Objectives (SBOs) in consultation with medical doctors, and developed a program for the physical assessment training course following a Learning Strategy (LS). To evaluate the program, we conducted a questionnaire survey and asked participants to carry out a self-assessment before and after the program. The survey results showed a high level of satisfaction with the training course and self-assessment scores after the course were significantly higher than before it. We therefore felt that our program was useful and appropriate for the people taking it.
We investigtated the preventive and inhibitory effects of goshajinkigan with regard to oxaliplatin-induced peripheral neuropathy in 29 patients who received mFOLFOX6 (± bevacizumab) for colorectal cancer in the Department of Surgery at Gunma Saiseikai Maebashi Hospital, from January to December 2010. A comparison was made between 3 groups: prophylactic coadministration of goshajinkigan group (combined with mFOLFOX6 at beginning (± bevacizumab)), therapeutic coadministration of goshajinkigan group (combined with mFOLFOX6 at onset of peripheral neuropathy (≦ grade1)) group and no goshajinkigan group. The endpoints were grade changes in peripheral neuropathy associated with continuous mFOLFOX6 (± bevacizumab), inhibitory effect ≧ grade1 and ≧ grade2 neurotoxicity in relation to the total dose of oxaliplatin, and TTF of mFOLFOX6 (± bevacizumab). The inhibitory effect with respect to peripheral neuropathy and TTF were investigated using Kaplan-Meier analysis and tested by the Log-Rank test. The results for all endpoints suggested that goshajinkigan had preventive and inhibitory effects in oxaliplatin-induced peripheral neuropathy where prophylactic coadministration of goshajinkigan > therapeutic coadministration of goshajinkigan> no goshajinkigan. Prophylactic coadministration of goshajinkigan achieved a significant inhibitory effect in grade 2 or worse peripheral neuropathy in relation to the total dose of oxaliplatin (p=0.002). These findings suggest that goshajinkigan can be used as a prophylactic and therapeutic agent in oxaliplatin-induced peripheral neuropathy.
Sorafenib is an oral multikinase inhibitor for the treatment of patients with advanced hepatocellular carcinoma (HCC). However, it produces various adverse reactions (hand-foot syndrome, hypertension, diarrhea, etc.) that often lead to discontinuation of treatment, a clinical problem that needs to be addressed. In this study, we retrospectively reviewed the medical records of 50 patients with HCC who had been treated with sorafenib at Kyoto University Hospital to investigate factors influencing discontinuation of treatment continuation as well as development of adverse events. The overall rate for discontinuation of treatment (including treatment termination and dose reduction/interruption) due to adverse events was 56%, and that for treatment termination due to progressive disease was 30%. The frequency of discontinuation due to any reason within the first month was significantly higher in patients starting with 800 mg / day (19/35, 54.3%) than with 400 mg/day (3/15, 20.0%). In addition, the median duration of successful treatment with the starting dose was longer in patients on 400 mg/day than 800 mg/day (89 days vs. 29 days). The development of hand-foot syndrome (grade>2)or diarrhea (any grade) was significantly associated with female sex and liver dysfunction at baseline (Child-Pugh B/C), respectively. In conclusion, when sorafenib is administered at 800 mg / day to HCC patients at high risk of adverse events, we should take measures for the early management of adverse effects and consider dose modification, which may help to sustain sorafenib therapy for a longer period with no discontinuation due to severe adverse events.
Regarding the dose amount of steroid ointments, package inserts gives no precise direction and it is necessary to clearly determine the standard method for dose setting. For this purpose, a method called ‘Finger Tip Unit (FTU)’ has been proposed in a guideline for atopic dermatitis, but this method has some demerits that it assume the same caliber of ointment tubes' head among different drugs' formulations and also it does not consider inter-patients' variability of body surface area. In order to establish a new dose setting strategy instead of FTU, we propose a new standard method which is based on the calculated surface area of body regions that drugs are applied. This method uses the published data of age, body weight, height, and surface area ratio of each body region to whole body surface area. Consequently, an equation to calculate the length of ointment to be squeezed out of a tube is presented for each body region, and we also propose the length for a unit area which is useful for applying to small area on any body regions. These results would be useful in the points that it clearly determine dose amount of steroid ointments and also it lead to an improvement of patients' adherence as well as improving clinical efficacy of steroid ointments.
Previous studies have indicated that there is significantly less insoluble microparticle contamination with plastic ampoules than with glass ampoules. Therefore, it is recommended that plastic ampoules are used except for certain purposes such as quality management. However, no studies have been done on the effect of standing time after opening plastic ampoules, and the purpose of this study was to investigate a relationship between standing time and plastic particulate sedimentation after opening them. All of the ampoules used were snapped open by hand and left to stand undisturbed for 10, 15, 20, 25, 30, 45, 60 and 120 seconds. Liquid was aspirated from the tilted ampoules using an 18G non-filtered needle attached to a 30 mL syringe and then their contents were diluted with 20 mL distilled water and passed through a 0.20 μm membrane filter. Persistent particles were measured using a KL-04 particle counter after aspiration of the ampoule contents. Our results suggested that accumulated plastic particulate contamination with a particle size over 2.0 μm increased significantly after 60 seconds. This finding may help reduce or prevent injection of plastic particles into patients, and the use of filters may further decrease this risk.
Using a formula for calculating the glomerular filtration rate (GFR) for Japanese announced in 2009, individual patients' GFRs can be predicted by inversely correcting the formula with body surface area. In this study, we investigated the influence of the dissociation between the GFR normally employed to calculate the dose and inversely corrected GFR on carboplatin (CBDCA)-related thrombocytopenia. In a group with grade 3 or higher thrombocytopenia, the dissociation between the GFRs used to calculate the dose of CBDCA was significantly greater. Also, in an analysis of thrombocytopenia-related factors, including concomitant anti-cancer agents, the only significant difference was that regarding GFR dissociation. These results suggest that the introduction of the inversely corrected GFR for accurate calculation of the GFR and setting of CBDCA doses is useful in decreasing the incidence of serious thrombocytopenia.
We developed a scale for measuring pharmacists’ communication skills with respect to cancer patients. To this, we first devised 41 questions for improving communication skills needed for receiving cancer patients. We then carried out a questionnaire (41 questions with 1-5 graded Likert scale) survey of pharmacists (n=584) during August 2010. The collection and response rates were 36.3%. We used the completed responses from the 212 pharmacists for testing the reliability and the validity of our scale. Five factors (“Problem solution skill”, “Skill in understanding patient psychology”, “Self-control skill”, “Skill in ending reception period”, and “Skill in reporting to a patient and their family”) were extracted from 29 questions for a factor analysis. There was a high coefficient of correlation between our scale and the KiSS-18 (Social Skill) (r=0.618). The reliability of this scale showed high internal consistency (Cronbach α coefficient=0.916); thus the result of test for the validity of this scale supports high content validity. We propose the name Topics-29 for our pharmacist communication skill measuring scale.