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Objective@#To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. @*Methods@#This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. @*Results@#Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. @*Conclusion@#Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.
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Objective: In order to increase the efficiency and effectiveness of pharmacotherapy and maximize the benefit/risk ratio, patient follow-up after medication is imperative. Such follow-up includes medical adherence, drug efficacy, early detection and treatment of adverse events. All pharmacy pharmacists should, at their service counter, select and correctly identify the most noticeable symptoms of adverse drug reactions for the patient, especially with their other roles and responsibilities. Thus, we evaluated the usefulness of M*Adhere SPEHEC® in pharmaceutical management.Methods: During the month of April 2019, 21 pharmacists at six pharmacies responded to the survey.Results: Of 21 pharmacists, 18 (85.7%) stated that the efficiency and/or quality of pharmacotherapy management had improved. The system enabled evidence-based identification of drug adverse event symptoms, and the time for pharmaceutical care was reduced by an average of 2 min.Conclusion: Based on these results, M*Adhere SPEHEC® was confirmed to be highly useful in improving the efficiency and quality of pharmaceutical management for patient follow-up.
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Objective: We have developed an automatic vigilance system (AVS) that automatically reports adverse drug reactions (ADR) based on laboratory finding abnormalities and symptom keywords in electronic medical records. In this study, we aimed to evaluate the impact of detecting ADR using AVS on medical treatment.Methods: In AVS, drugs and their ADR signals, which would be detected and reported by AVS to pharmacists, were defined. Pharmacists evaluated the severity of these signals to identify whether these signals should be discussed with the doctor, continued to be followed up, or ignored. We investigated detection of ADR at University of Fukui Hospital between April 2016 and March 2017 along with whether prescriptions were modified because of ADR and the contribution of AVS. Assuming that ADR had worsened without appropriate treatment, medical expenses needed for treating severe ADR were calculated.Results: In total, 325 signals were defined for 146 drugs. There were 9,103 ADR signals confirmed by pharmacists for 8,531 subjects. Of these, 12 and 164 signals were discussed with the doctor and continuously observed, respectively. The pharmacist's suggestions based on AVS led to prescription modifications in 10 cases, corresponding to a reduction of 2.56 million yen in medical expenses in the event that these cases become severe.Conclusion: AVS assisted prescription revisions because of ADR and is thought to contribute to the prevention of worsening of ADR and reduction of medical expenses.
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A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.<br>1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities<br>2．How to select Safety Specification (SS) and describe its characteristics<br>・Selection of SS<br>・Characterization of SS<br>・Association with Research Questions (RQ)<br>3．How to define and describe RQ<br>・What is RQ ?<br>・RQ interpretation in other relevant guidelines<br>・Methodology to develop RQ for PVP with examples<br>・Best approach to integrating PVP for whole aspects of safety concern<br>4．How to optimize PVP for specific RQ<br>・Routine PVP or additional PVP ?<br>・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)<br>・Checklist to help develop PVP<br>5．Epilogue:<br>・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.<br>・Significance of background incidence rate and needs for comparator group<br>・Infrastructure for the future PVP activities<br>6．Appendix: Checklist to help develop PVP activities in RMP<br>The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.
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<b>Objective: </b>In recent years, the Ministry of Health, Labor and Welfare has actively promoted the use of generic drugs. However, implementation of this policy has not progressed smoothly, as information on generic drugs is poorly organized. As a result, it is difficult for pharmacists to select the appropriate generic drugs. Therefore, we attempted to develop a code system to organize information on generic drugs.<br><b>Methods: </b>We analyzed the guidelines used for the approval of generic drugs. We then identified the important aspects for comparison of generic drugs and developed a code system. Next, we tested this code system using temocapril hydrochloride tablets, which is a generic drug.<br><b>Results: </b>We were able to develop a code system for selection of generic drugs. Furthermore, we confirmed the utility of this code system for selecting generic drugs in the case of temocapril hydrochloride tablets.<br><b>Conclusion: </b>We believe that this code system with be useful for pharmacists, but further development is necessary for other generic drugs.
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<b>Objective: </b>The purpose of this study is to identify the problems in the adverse drug report (ADR) system in early post-marketing vigilance phase (EPM phase) in Japan.<br><b>Methods: </b>The incidence of all ADRs and the ratio of serious ADRs were compared between the new drug application phase (ND phase) and the EPM phase. The target medicines were Moxifloxacin (Avelox®tablets, 400mg), Gatifloxacin (Gatiflo®tablets, 100mg) and Prulifloxacin (Sword®tablets, 100mg).<br><b>Results: </b>The average incidence of all ADRs in the ND phase was 100-fold greater than that in the EPM phase. There were also 2-fold differences in the ratio of serious ADRs of individual medicines.<br><b>Conclusion: </b>There are several problems with the ADR system in the EPM phase in Japan. It is currently possible that the implementation of EPM will vary between in individual medicines and companies. This suggests that the present data cannot be applied universally. Thus, there is an urgent need to standardize the implementation of EPM.