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.

Objective : Transarterial or transapical aortic valve replacement (TAVR) procedures have been performed for high-risk patients with severe aortic valve stenosis (AS) in western countries. A high-risk patient is defined as having an STS score greater than 10%. In Japan, aortic valve replacement (AVR) with cardiopulmonary bypass (CPB) is standard care for AS, even if the patient is at high risk of developing complications. We calculated an expected operative risk of patients using a JAPAN score established by Japanese Adult Cardiovascular Surgery Database (JACVSD). Patients and Methods : Patients were divided into three groups : score less than 5%, low risk (LR) ; score 5-10%, moderate risk (MR) ; score more than 10%, high risk (HR). We also evaluated the efficacy of conventional AVR in each group. Between January 2002 and May 2011, we performed conventional AVR in our hospital and 116 patients who underwent AVR for symptomatic AS were enrolled in this study. Results : There were 79 patients in the LR group, 30 patients in the MR group and 7 patients in the HR group. The mean score was 2.6±1.1% in the LR group, 6.8±1.4% in the MR group and 23.3±16.8% in the HR group respectively. The mean follow-up period was 7.6±0.3 years. Preoperative co-morbidity was not statistically significant among three groups, however more octogenarians were found in the HR group. The aortic valve area and left ventricular ejection fraction (LVEF) were significantly smaller in the HR group. There were 4 cancer patients. The HR group had significantly longer operation and CPB times than the LR group. The operative mortality in all cases was 1.6%. Overall survival at 5 years was 78%. Actual survival at 5 years was 77% in the LR group, 82% in the MR group and 71% in the HR group. The major adverse cardiac and cerebrovascular event (MACCE)-free ratio at 5 years was 85%. Absence of death caused by MACCE at 5 years was 93%. All cancer patients died after AVR due to advancement in cancer. Conclusion : The results of conventional AVR with CPB were satisfactory in each group. Cancer patients may be good candidates for TAVR in the future.

  On July 7, 2010, a 74-year-old man came to our hospital, complaining that he had a nagging pain in his chest that started the preceding day. After performing electrocardiography, blood tests and electrocardiography, we diagnosed the case as acute myocardial infarction. At first, it was thought that blood flow could be restored in due course of time, antiplatelet and anticoagulant agents were used. Intracardiac catheterization was not included in our initial treatment plan. Three days after the initiation of the treatment, the patient had pain in his left inguinocrural region. Computed tomography and magnetic resonance imaging reveled hematoma in his left iliopsoas muscle. We stopped administering antiplatelet and anticoagulant agents to him. But anemia progressed from Hb14.1g/dL to 9.8 g/dL, so blood transfusions had to be given. After that, the patient underwent a rest cure. With the passage of time, the pain and swelling of the left iliopsoas muscle went down. Regarding the cardiac condition, however, the pain in the chest did not abate even when he was taking a rest. The antiplatelet therapy was resumed, with one type of agent given at first and then with another type added. Examinations using a coronary CT and a cadiac catheter found 90% stenosis at the proximal left anterior descending coronary artery. So, a bare metal stent was placed in the near-closed artery. Ever since, there has been no recrudescence of chest pain and no recurrence of iliopsoas muscle hematoma. The extravascated blood mass seemed to be dissolved spontaneously.