As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.

Objective: Incidents, such as disturbance of consciousness due to adverse reactions of medications during automobile driving, could cause a serious accident.  Although automobile driving is indicated to be “prohibited” in the package inserts of many drugs, no explicit guidelines are available in Japan on specific guidance to patients.  Therefore, we attempted to prepare guidelines for medication guidance regarding automobile driving.
Methods: We investigated the number of incidents involving traffic accidents and the disturbance of consciousness cases reported in “Japanese Adverse Drug Event Report” database by “Pharmaceuticals and Medical Devices Agency (PMDA).”  We also analyzed descriptions regarding automobile driving found in package inserts and guidelines to determine a risk level for each medication.
Results: Guidelines for medication guidance were prepared based on four-level classification of drugs for which “prohibition” of automobile driving was indicated in their package inserts; these levels are “conform to pertinent guidelines,” “strictly prohibited,” “prohibited,” and “conditionally prohibited.”  The contents of the guidance prepared for some drugs were different from their package inserts.
Conclusions: The guidelines prepared in this study can be expected to become a support tool to ensure close attention to cautions regarding automobile driving.  Because some contents of the guidance are different from that described in the package inserts, it is desirable to obtain agreement with physicians in hospitals adopting these guidelines.  In addition, guidelines based on a broader range of information should be prepared in the future.

Objective: When vehicular accidents occur as a result of impaired consciousness etc., because of adverse drug reactions, there is a risk that third parties may be harmed.  Till date, at Nagoya City East Medical Center (hereinafter, our hospital), the warnings about driving motor vehicles while taking drugs has varied depending on the doctor or pharmacist who provides the guidance.  Therefore, throughout our hospital, we aimed to standardize these warnings and to introduce measures to strictly enforce them.
Methods: Among all the drugs used at our hospital, we identified those with warnings on the package insert about driving motor vehicles and classified them in accordance with “The Drug Administration Guidance Criteria Regarding the Driving of Vehicles,” created by our hospital on the basis of descriptions on the package insert and the level of risk of taking drugs.  We then standardized the warnings about driving motor vehicles while taking drugs, throughout our hospital.
Results: Of the 1,416 drugs used at our hospital, we identified 294 (21%) with warnings about driving motor vehicles on the package insert, and more than half of these (158 drugs) had warnings about the prohibition of driving motor vehicles on the package insert.  As a result of classifying the drugs according to “The Drug Administration Guidance Criteria Regarding the Driving of Vehicles,” we identified 53 drugs with warnings about the prohibition of driving motor vehicles.  By the classification of the level of risk of taking drugs while driving motor vehicles and the hospital-wide standardization of the warnings about driving motor vehicles while taking drugs, we are now able to provide drug administration guidance in the form of warnings that are customized to the level of risk of using each drug.
Conclusion: These measures have clarified the level of risk of taking each drug and warnings about driving motor vehicles while taking them.  In the future, we intend to cooperate with local pharmacies to intervene in the prescription of drugs outside well as inside hospitals.

Endoscopic management is presently the recommended first-line of treatment for biliary strictures. However, surgery still has an important role especially for biliary obstruction (BO) with duodenal obstruction. Even though endoscopic treatment for concurrent BO and gastric-outlet obstruction has been proposed, it is still not widespread. Duodenal obstruction is often associated with malignant BO which makes endoscopic treatment more challenging. Biliary and gastrointestinal double bypass with Roux-en-Y hepaticojejunostomy and gastrojejunostomy is the most common surgical intervention for malignant biliary and gastric-outlet obstruction. A variety of procedures of biliary bypass and gastrointestinal bypass have been reported. According to several studies, mortality rates range from 0% to 7%, while morbidity rates range from 3% to 50%. Higher morbidity was observed in symptomatic patients caused by the disease. Most common morbidity after double bypass was delayed gastric emptying. Recurrence of BO and gastric-outlet obstruction was less frequently seen after surgical bypass compared to after endoscopic treatment. Minimally invasive approach has been applied to double bypass. Studies showed that laparoscopic double bypass has a shorter hospital stay and reduced postoperative pain; however, due to its technical demand, it is still presently an uncommon procedure. Robotic bypass surgery may resolve this issue in the future. Further analyses of outcomes of both surgical and endoscopic treatments are necessary to establish better and suitable palliation options for concurrent biliary and duodenal obstruction caused by unresectable malignant tumors.
Cholestasis ; Constriction, Pathologic ; Duodenal Obstruction ; Gastric Bypass ; Gastric Emptying ; Humans ; Length of Stay ; Mortality ; Pain, Postoperative ; Recurrence ; Surgical Procedures, Operative