Treatment outcome studies have been the main part of post-marketing surveillance (PMS) in Japan, but it seems burdensome for medical practitioners to conduct them due to the lack of support compared to that for clinical trials. The Ministerial Ordinance on Good Clinical Practice for Drugs (Ordinance of the Ministry of Health and Welfare No 28 of March 27, 1997, GCP) applies to clinical trials to ensure a certain level of quality of clinical trials. But there have been no reports investigating the quality of treatment outcome studies in medical institutions. Therefore, we conducted a questionnaire survey of medical representatives (MR) on the treatment outcome study practice in medical institutions. The result shows that MRs are not satisfied with the speed of the studies, but with the quality in general. It also shows that physicians sometimes refuse to fill in or correct the case report form due to their busy practice, and it is suggested that not only medical practitioners but MRs have been overloaded with conducting treatment outcome studies. Known/mild adverse events are more often missed from reports, even though such event names are pre-specified in the form. It is important to plan treatment outcome studies focusing on important safety issues, which will lead to improvement of the studies as a whole. The quality of treatment outcome studies is expected to improve if their burden of preparing the report forms is reduced by focusing on important matters for investigation.
The objective of this study was to grasp patients' thoughts and feelings that are directly linked to their medication nonadherence. We provided communication skill training to pharmacists, focusing on observation of patients' expressions. The training encourages pharmacists to observe patients while providing explanations and ask open-ended questions in response to changes in the patient's expressions. The participants were 51 pharmacists. Significant improvements were seen after the training in both the recognition rate of changes in patients' expressions and the acquisition rate of new data from patients after asking open-ended questions. Open-ended questions accompanied by observation led to a significantly higher acquisition rate of new patient data compared with open-ended questions alone. More detailed data regarding problem-oriented medical record was provided in patients' subjective data after the training, and consequently, significantly improved the quality of pharmacists' care; for instance, this improvement included encouraging the development of more suitable care plans for patients. In addition, the results of the patient questionnaire showed almost all patients, including those who said that they were not normally able to do so, could ask questions or consult the pharmacist after the training. The most common reason given for this was that “the atmosphere was conducive to asking questions and there were opportunities to do so.” These findings suggest that when pharmacists observe changes in patients' expressions for the purpose of asking open-ended questions, more attention is given to the patients, thereby promoting a more comfortable atmosphere and creating more opportunities for patients to ask questions.
Pharmacists are required to form a partnership with their patients in order to support their recuperation; however, pharmacists have few opportunities to learn how to acquire high-quality communication skills while providing patient-centered care. Therefore, we created a new simulated patient (SP) participatory learning program using the Database of Individual Patient Experience-Japan (DIPEx-Japan), and verified its effectiveness and influence. The program comprised three stages: orientation, SP sessions plus general discussions using a video and a transcript of the SP session. For the SP sessions, we set up 10-min role-play situations between the SPs and the participants. After the role-play, the participants reflected on and discussed their communication skills during the role-play in small groups. General discussions with all the SPs and participants were conducted, based on the video and the transcript, to deepen the participants' understanding of the communication. The program's effectiveness and influence was evaluated using a 30-item questionnaire survey of awareness and behavior regarding pharmacist-patient communication. The results of the investigation were analyzed by student's t-test, analysis of variance, and correlation analysis. One hundred fourteen pharmacists participated in the program. Comparison of the responses before and one month after the study showed improvement in both awareness (P < 0.05) and behavior (P < 0.01). Our new SP participatory learning program focusing on the patient's background, thoughts, and feelings was able to improve awareness and behavior among pharmacists. Our program improved the communication skills of pharmacists and is expected to contribute to better pharmacist-patient communication.
A woman in her fifties with ovarian cancer (endometrioid adenocarcinoma, Stage Ⅲc, pT3cN1M0) received adjuvant dose-dense paclitaxel and carboplatin chemotherapy (monthly: paclitaxel 80 mg/m2 Days 1, 8, 15 + carboplatin AUC5 Day 1). She developed asymptomatic transaminitis and an elevated gamma-glutamyl transferase level without jaundice. The calculated alanine transaminase (ALT) and alkaline phosphatase (ALP) value indicated cholestatic injury or mixed hepatocellular and cholestatic injury. After ruling out other causes, the liver injury was etiologically attributed to paclitaxel and subsequently resolved with its dose reduction as Days 1, 8: 60-80% dose and Day 15: 80-100% dose. Chemotherapy was suspended only once because of grade 3 neutropenia, although she continued dose-dense chemotherapy in spite of mild liver abnormalities. The findings of this case suggest that liver dysfunction due to paclitaxel is dose-dependent, and that careful attention to the treatment of neutropenia is required for patients with liver abnormalities.
Greater importance has been placed in recent years on the need for students to clearly see the effects of medication on patients. In this study, we examined whether a simulator is a useful implement in practical pharmacology training. We administered sympathomimetic drugs in a high-performance patient simulator, “SimMan 3G,” which had been set up to mimic a person in a healthy state. We observed on a PC monitor that epinephrine (0.25, 0.5, 1.0 mg) caused a dose-dependent increase in blood pressure, pulse rate and cardiac output in the SimMan 3G, as well as pupillary dilatation and sweating. Epinephrine (0.5 mg) was administered intravenously (iv), subcutaneously (sc) or intramuscularly (im). The levels of sympathomimetic responses appearing after the sc and im injections were half those appearing after iv injection. Epinephrine, norepinephrine or isoprenaline (10 μg/min) was administered at a higher dose than usual in iv drip form. Norepinephrine caused an increase in blood pressure and a decrease in cardiac output. Isoprenarine caused an increase in heart rate and cardiac output during and after administration. Dopamine or dobutamine was infused at 1, 5 or 10 μg/kg/min. The dose-dependent effect of dopamine, and also the differing effects of dobutamine and dopamine, could be clearly observed. Students were able to verify the relationship between adrenaline receptors and the adrenergic effect on the simulator. These results suggest that SimMan 3G is useful for practical pharmacology training.
Midazolam is metabolized by cytochrome P450 (CYP) 3A4, and voriconazole inhibits CYP3A4 activity. Although it is well known that midazolam interacts with voriconazole, there have been no reports about the sedative effect of midazolam when administered in combination with voriconazole, followed by discontinuation of voriconazole. Here, we describe one such case. The patient was administered voriconazole followed by midazolam with the aim of inducing sedation. The drugs were administered for 4 days, after which voriconazole was discontinued. Although the midazolam administration rate remained constant, the patient recovered consciousness approximately 24 hours after the last injection of voriconazole. Therefore, the flow rate of midazolam was increased to a rate 8 to 9.7 times higher than that used during the combined administration of voriconazole and midazolam. Thus, this case shows that it is necessary to increase the dosage of midazolam and to monitor patients carefully when voriconazole is discontinued after being administered in combination with midazolam.
Information on ethical drugs is managed by medication notebooks but information on over-the-counter (OTC) drugs and dietary supplements is hardly covered. Therefore, it is important to understand the awareness about medication-notebook use on the purchase of OTC drugs and dietary supplements and to take measures to improve awareness. In our study, in order to understand the awareness and situation of medication-notebook use and clarify the effect of group instructions for improving the awareness, we gave a lecture about medication-notebook use and investigated items such as awareness about medication notebooks before and after the lecture. We conducted a questionnaire survey in 80 participants in a public lecture in Gifu Municipal Hospital on April 19, 2014. The lecture explained about medication notebooks and their usefulness for ethical drugs, OTC drugs and dietary supplements, etc. The items of the questionnaire were, for example, awareness about medication-notebook use for ethical drugs, OTC drugs and dietary supplements (Likert scale, evaluation 1-5). The recovery rate of questionnaires was 80.0％. Regarding the awareness about medication-notebook use for OTC drugs and dietary supplements, the rates of evaluations 4 and 5 before the lecture were low (30-50%) regardless of ways of purchasing them, but the evaluations increased significantly after the lecture (P < 0.05). Our study clarified that awareness about using medication-notebooks for OTC drugs and dietary supplements is insufficient at present and suggested that group instructions about medication-notebook use improve awareness.
Various multidrug combination chemotherapy regimens with 5-fluorouracil (5-FU) as a basic drug are administered for unresectable advanced/recurrent colorectal cancer. S-1/CPT-11 treatment with tegafur/gimeracil/oteracil potassium (S-1), an oral derivative of fluorouracil (5-FU), and irinotecan (CPT-11), a DNA topoisomerase I inhibitor, which have different mechanisms of action, is expected to exert a therapeutic effect. However, the safety and feasibility of this therapy in elderly patients have not yet been well established. In this study, we retrospectively examined the safety and feasibility of S-1/CPT-11 therapy in elderly patients. Regarding safety, the neutrophil counts showed significantly milder decreases with S-1/CPT-11 therapy (Group A) than with standard-dose S-1/CPT-11 therapy (IRIS) (Group B)(P = 0.045). The severity of these decreases tended to be high, especially in Group B. Regarding the feasibility of therapy, the relative dose intensity decreased in Group B with values of 90.1 and 74.4 Groups A and B, respectively (P = 0.002). The median progression free survival did not differ significantly, with respective values of 4.5 and 4.6 months in Groups A and B. These results suggest high-level safety and feasibility, as well as favorable tolerability, of S-1/CPT-11 as a third-line therapy in clinical practice. Further examination of the effects on elderly patients is required.