This study determined the effects of long-term storage under various conditions after opening press through package (PTP) sheets on the stability of each tablet formula of statin for treatment of dyslipidemia and clarified the difference in stability between brand-name drugs and generic drugs. It was demonstrated that opened Crestor® tablets were stable for one year under the conditions of diffused light at room temperature and shielded light at room temperature. Although the content of rosuvastatin in ground Crestor® tablets was greatly decreased after only 1 month under the condition of diffused light, it was stable for at least 3 months under shielded light, indicating that shielded light is necessary for storage of ground Crestor® tablets. Of the four tablet formulae of simvastatin tested, only Lipola®M was within the stability standards after storage for 6 months under all conditions. The other tablet formulae of simvastatin showed changes in hardness or elution pattern even under the condition of shielded light at room temperature, indicating that care is needed in preparing one-dose packages of these formulae. Four tablet formulae of pravastatin used in this study were stable for 6 months under shielded light at room temperature. It was also found that three of the five formulae with decreasing elution velocity contained crospovidone and that the other formulae contained no crospovidone. This decrease in elution velocity appears to be due to reduction in porosity of the tablet caused by high humidity.
Daptomycin (DAP), a novel anti-methicillin-resistant Staphylococcus aureus (MRSA) drug, produces a bactericidal effect with a very rapid onset and is expected to be efficacious. However, the induction of muscle toxicity has been reported in the United States, but there have been few reports on the safety of the drug in Japanese people with a smaller physique and lower muscle mass. In this study, the efficacy and safety of DAP were evaluated in 66 patients on infection with gram-positive cocci (males, n = 32; median age: 65 years). The treatment was effective in 70.9% of the 55 patients in whom the treatment effects could be evaluated, and the response rate was particularly high in wound infection (83.3%) and urinary tract infection (88.9%). While a significant prolongation of the international normalized ratio, rash, etc., were observed as adverse reactions, no sign of muscle toxicity was identified, and no significant increase in creatine kinase was noted. The results of this study suggest the satisfactory efficacy and safety of DAP against infection with gram-positive cocci.
A portfolio-related questionnaire survey was conducted involving 95 fifth-year pharmacy students (term 1: 31; term 2: 32; and term 3: 32) who had completed a long-term clinical training program in academic year 2012. Among these students, 69.5% answered that the duration of portfolio evaluation was "appropriate," and 72.6% answered that such evaluation was "very useful" or "useful." In another survey that examined students' understanding of questions arising daily during clinical training involving 32 students of the term-3 group, the rate of correct answers was 58.3% when the students shared such questions and discussed them in presentations after the survey, 39.6% when only a survey was conducted to examine them, and 21.9% when the students did not listen to presentations or self-study. In contrast, their levels of understanding (memory) improved when they made presentations, or participated in discussions after self-study.
Only two dosage forms, 5 and 10 mg/pack, are commercially available for immediate-release morphine solutions. For this reason, patients requiring high dose morphine use a pack quickly, while suffering from breakthrough pain. In Nagoya University Hospital, we prepared high-concentration morphine aqueous solution for these patients by dissolving morphine hydrochloride powder. However, the maximum prescription period of this solution is set to 14 days by the internal rules of the pharmacy because it contains no antiseptic. Therefore, the patients must visit the hospital every 14 days to obtain the prescription. Whereas the maximum prescription period of morphine hydrochloride tablets is 30 days. Thus, the frequency of patient visits can be reduced by half if the patients themselves can prepare morphine solution from morphine tablets by a simple suspension method. Therefore, we examined the disintegration of morphine tablets by a simple suspension method, and the stability of morphine in the suspension. Initially, 5 or 20 tablets of “10-mg morphine tablet” were added to 20 mL of tap water at 55 °C, and disintegration of the tablets was macroscopically checked. Tablets were completely disintegrated in 5 minutes and in 10 minutes, respectively. Next, to evaluate the stability of morphine in the suspension, morphine concentration was measured by high-performance liquid chromatography until 28 days after suspending the tablets. The residual rate of morphine in the suspension was between 96.7% and 104.8%. These results suggest that morphine solution can be prepared from the tablets using a simple suspension method.
This study investigated the effect of using the neurokinin-1 receptor antagonist and 5-hydroxytryptamine-3 serotonin (5-HT3) receptor antagonists of the second generation on the rate of incidence of anticipatory nausea (AN) and patients' factors among ambulatory cancer patients receiving chemotherapy. Randomly selected patients who received high emetic chemotherapy or moderate emetic chemotherapy were asked to complete the Morrow Assessment of Nausea and Emesis scale, the Hospital Anxiety and Depression Scale, and the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. The evaluations were conducted twice (beginning-of-using before and after the new antiemetic drugs [neurokinin-1 receptor antagonist and 5-HT3 receptor antagonist of the third generation]). Complete data were available for 267 subjects (119 before using new antiemetic drugs; 148 after using new antiemetic drugs). A total of 15.1% vs 6.8% of the patients experienced AN before and after using new antiemetic drugs (P < 0.05). After using new antiemetic drugs, patients' global quality of life score was significantly improved. The findings suggest that the rate of incidence of AN in ambulatory cancer patients who receive chemotherapy was reduced by using new antiemetic drugs.
A safety management system should be established to prevent medication errors in pharmacies. Ain Pharmacy Fushimi introduced several devices in order to decrease the dispensing errors. However, errors originating from the input and the picking processes still remain. In this study, we report the effect of introducing two automated dispensing devices. One is an optical character reader (named FACE, FACE Co, Ltd Tokyo) and another is a machine specialized in fully automated preparation of press-through package (PTP) tablets seat (trade name “Robo-pick,” Yuyama Co, Ltd Osaka). The incidence rates during the four months before and after the introduction of these systems were compared. The whole incidence rates decreased from 0.011 to 0.002% (P < 0.001) significantly. The incidence rate related to the input process of prescription data into the receipt-computer decreased from 0.008 to 0.001% (P < 0.001), and the incidence rate related to picking mistake decreased by half, from 0.002 to 0.001% (P = 0.006). The study showed that the introduction of the two devices significantly reduced the number of incidents occurring during the dispensing process. The reduction of incidents or accidents by introducing automated dispensing devices may allow pharmacists to concentrate more on checking prescriptions and consultation on the medication for patients, where their professional expertise is most required.
Denosumab is a fully human monoclonal anti - receptor activator for nuclear factor κB ligand (RANKL) antibody, which suppresses the differentiation, activation, and survival of osteoclasts by inhibiting the binding of RANKL to its receptor, RANK. In a phase Ⅲ clinical trial, denosumab significantly decreased the time-to-first and time-to-first-and-subsequent skeletal related events (SRE) in advanced cancer patients with bone metastases. One of the most important adverse reactions of denosumab is hypocalcaemia. So, we prepared a preset prescription formula that includes calcium lactate 4 g/day and alfacalcidol 0.25 μg/day so as to prevent hypocalcaemia, which might be caused by denosumab. We retrospectively examined the efficacy and safety induced by this preset formula on 35 patients who had advanced to bone metastases between the period of April 2012 and March 2013 at our medical center. In our preset formula patient group, no hypocalcaemia or hypercalcaemia symptoms were observed. We conclude that our formula (calcium lactate 4 g/day and alfacalcidol 0.25 μg/day) is safe and effective to prevent hypocalcaemia presumably caused by denosumab treatment.
Loxoprofen (Loxonin®) is a widely administered non-steroidal anti-inflammatory drug (NSAID) in Japan, with annual sales exceeding 50 billion Japanese yen. Although it is a very versatile drug and is often administered to breastfeeding women, the information available regarding its mammary gland transfer is inadequate. Therefore, in this study, we analyzed loxoprofen levels in the blood and milk of four breastfeeding women who received the drug for pain relief. These women visited the Obstetrics and Gynecology Department of Hanwa Sumiyoshi General Hospital for consultation or a cesarean section. One tablet of Loxonin® (loxoprofen 60 mg) was orally administered to each of the four women, and blood and milk samples were collected 0, 30, 90, 150 and 330 min after drug administration. Twenty microliters of ethanol was added to the blood and milk samples (10 μL), and the mixture was centrifuged at 12000 g for 15 min. The supernatant was analyzed by high-performance liquid chromatography (HPLC). Loxoprofen levels in blood peaked 90 min after its oral administration in all four patients, with the highest level being 4.5 μg/mL in patient II, whereas loxoprofen level in milk was below the detection limit (0.1 μg/mL) at all time points. Taken together, the data suggest low mammary gland transfer of loxoprofen, and thereby a low lactation risk.