Objective: 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.
Methods: 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.
Results: 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.
Conclusion: We believe that this code system with be useful for pharmacists, but further development is necessary for other generic drugs.

Two patients of chronic mediastinitis after cardiac surgery were treated by omental transfer. Their previous cardiac operations were open mitral commissurotomy and aortic valve replacement. They underwent radical surgical therapy for mediastinitis 8 to 9 years after the first cardiac surgery. In both cases, the infection resulted from Dacron felt on the ascending aorta. Under the cardiopulmonary bypass, the Dacron felt and infected tissue were resected. And omental transfer was done to prevent recurrent infection. The patients have been follwed up for 10 to 14 months. And they have no symptoms of their mediastinitis during these periods. From these experience, we consider that omental transfer is very helpful to treat infectious complications after cardiac surgery.

From January, 1975 to December, 1989, 231 Björk-Shiley prostheses have been implanted in our hospital. During this period, we have experienced thrombosed valves in 0.69%/pt-yr for the aortic and 1.2%/pt-yr for the mitral position. Ten patients, four in the aortic and six in the mitral, have had thrombotic obstruction of a prosthetic valve. Seven cases of them had insufficient warfarin control. Clinical signs of thrombosed valves were dyspnea, thromboembolism and abnormal cardiac sound. Cineradiography was the most useful diagnostic method. Two cases underwent thrombolytic therapy, but one case died of cerebral complication and another needed an emergency cardiac operation 24 hours after the onset. Six survived among the eight surgical cases. We concluded that thrombosed valves mainly resulted from an insufficient anticoagulant therapy and an urgent surgical intervention would better be performed.

In this report, we describe our surgical experience with seven cases of acute type A aortic dissection which resulted from retrograde propagation from tears in the proximal descending arota. As an emergency procedure, we used a ringed intraluminal prosthesis in six patients and five of these survived. All survivors underwent follow up CT scanning during a period ranging from 4 months to 5.6 years after surgery, especially to evaluate the fate of the false lumen on the residual aorta. In four patients, the arch dissection has been completely occluded by thrombosis, however, it remained patent in one patient 2.3 years postoperatively in whom reentry was found in the arch vessel at the time of operation. Enlargement of the false lumen beyond the descending aorta was found in two patients. On the other hand, the results have been excellent in the most recent patient who underwent complete graft replacement of both the ascending aorta and aortic arch including the primary tear. The authors believe, therefore, that the complete graft replacement of the ascending aorta to the aortic arch should be considered as the procedure of choice in these particular patients. Only such procedures enable the complete healing of both the ascending and arch dissection, and reoperation can be confined to the area distal to the descending aorta, if necessary.

Objective: 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.
Methods: 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).
Results: 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.
Conclusion: 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.

Fifty-three patients who had received aortic valve replacement (AVR) using tilting disc valve prostheses (Lillehei-Kaster valve, Omniscience valve, Omnicarbon valve), underwent replacement of their aortic valve prostheses over the past 13 years. The indications for reoperation were non-structural opening failure in 35 patients, thrombosed valves, including 2 stuck valves in 8, prosthetic valve endocarditis (PVE) in 7 and perivalvular leakage (PVL) in 3. The interval periods until reoperation for opening failure and thrombosed valve were 112 and 118 months respectively, and for PVE and PVL were 21 and 25 months. There were 7 hospital deaths (13.2%). Surgical results in cases of active PVE with root abscess and stuck valve required emergency operation were significantly worse than these for nonstructural opening failure. Opening failures, which accounted for two-thirds of the indications for reoperation was found to be due to subvalvular pannus formation on minor orifices which hindered the disc from opening properly. It was suggested that reoperation for these types of prosthetic valve should be done before they develop into emergency cases, taking account of these valve-related complications.

Direct observation of the intravascular atherosclerotic change provides many diagnostic information and supports successful vascular surgery. Angioscopic inspections were performed in the 23 patients who underwent laser angioplasty for the peripheral arteries and 7 patients with aorto-coronary bypass surgery in this study. Useful images could be obtained in 19 (83%) of 23 observations in the peripheral arteries, and the successful rates of angioscopic observation were influenced by the diameter and the degree of kinking of each vessel. On the other hand, intraoperative observation of coronary artery with angioscope could be performed easily in all cases. From these findings, intraoperative application of angioscopy was considered to be useful procedure for the cardiovascular surgery.

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.
1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2．How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3．How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4．How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5．Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6．Appendix: Checklist to help develop PVP activities in RMP
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.