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.

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Objective: Many patients in Kagawa University Hospital are administered medicines prepared by the simple suspension method.  Pharmacists in charge of these patients receive inquiries from doctors and nurses regarding the suitability of medicines for the simple suspension method.  Answering these inquiries is complicated and time-consuming as multiple data sources need to be searched.  In order to simplify these complicated procedures, we herein attempted to develop a novel database to provide valuable information that could contribute to the safe performance of the simple suspension method, and evaluated its usefulness.
Method: The specifications of the database were determined by analyzing previously answered inquiries.  To evaluate the usefulness of the database, we used test prescriptions and compared the amount of time required to gather information using the database and the conventional method, i.e., using books alone.  We also analyzed previous prescriptions with the database in order to determine what kinds of problems could be detected.
Results: The investigation of previous prescriptions indicated that some medicines needed to be examined not only for their suitability for the simple suspension method, but also their incompatibility.  Therefore, we added a feature regarding the incompatibility of medicines to the database.  The time required to gather the information needed to answer the test prescription was shorter with our database than with the conventional method.  Furthermore, the database improved the detection of medicines that require particular attention for their properties including incompatibility.  An analysis of previous prescriptions using our database indicated the possibility of incompatibility in half of the previous prescriptions examined.
Conclusion: Our database could rapidly provide information related to the simple suspension method, including the incompatibility of medicines.

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Objective: Clinical trials are designed to clarify the dose-dependency of drugs.  However, the dose-dependency of adverse drug reactions (ADR), especially in the subtherapeutic range, often remains unclear.  Whether decreasing a drug’s dose would reduce the risk of ADR is of interest to both clinicians and regulators.  This study aimed to clarify the dose-dependency of ADR during subtherapeutic exposure to non-steroidal anti-inflammatory drugs, immunosuppressants, β-adrenoceptor antagonists, or corticosteroids.
Methods: Data about the ADR risk profiles and the area under the concentration curve (AUC) values of the examined drugs during their subtherapeutic administration, e.g., after their topical or low-dose oral administration, were collected from the literature and compared with data obtained during the therapeutic administration of the drugs; i.e., at the standard oral dosage.
Results: The drugs that exhibited AUC of ≥20% during their therapeutic administration continued to cause significant systemic ADR during their subtherapeutic administration.  Whilst the drugs that demonstrated AUC of 3-20% during their therapeutic administration continued to cause systemic ADR during their subtherapeutic administration, the ADR tended to be less frequent.
Conclusion: The dose-dependency of ADR can be estimated by comparing the AUC and ADR risk profile data for a drug obtained during its topical, parenteral, or low-dose oral administration with that obtained during its oral administration at the standard dose.  However, some studies have detected high ADR frequencies even during reduced systemic exposure, suggesting that factors affecting the risk of ADR, e.g., patients’ background data, should be carefully matched between the datasets being compared.

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Objective: The aim of this study was to establish the proper definitions of venous thromboembolism (VTE) and bleeding events for a healthcare database in Japan.
Study Design: Validation study.
Methods: The study comprised patients with VTE or who had undergone orthopedic surgery of the lower extremities and whose outpatient or inpatient medical information from April 1, 2008 to September 30, 2013 was available.  The source population of the database was derived from 100 acute-care hospitals.  The endpoints were VTE events (deep venous thrombosis [DVT], pulmonary thromboembolism [PE]) and bleeding events (bleeding requiring blood transfusion, intracranial hemorrhage, intraocular hemorrhage, upper gastrointestinal [GI] bleeding, and lower GI bleeding).  The frequent events with laboratory data were randomly extracted and evaluated, while all the infrequent events with laboratory data were extracted and evaluated.  Positive predictive value (PPV) was defined as the proportion of events judged to be clinical by medical experts of all the extracted events.  First, we conducted a test with a small number of cases and then revised the definitions of events.  Second, we extracted and evaluated data in 50 patients for VTE and bleeding events patients, based on which we defined the target PPV level between 60 and 70%.
Results: Of the 5,044,743 patients in the database, 36,947 patients underwent orthopedic surgeries of the lower extremities and 3,578 patients experienced a VTE event.  The PPV at the first evaluation was 80.0% (8/10) for DVT, 57.1% (4/7) for PE, and 27.3% (6/22) for bleeding events.  At the second evaluation using the revised definitions, the PPV were 75.0% (42/56) for VTE and 73.3% (33/45) for bleeding events.  Overall, the PPVs for VTE and bleeding events were over 70%.  The PPV of the VTE events were 76.9% (30/39) for DVT and 70.6% (12/17) for PE.  The PPVs of each type of bleeding event were over 70% except for intracranial hemorrhage (44.4%, 4/9).
Conclusion: The PPV was high for VTE events (75.0%) and bleeding events (73.3%).  The definitions used in this study are rational for the identification of VTE, DVT, PE, and bleeding events in the healthcare database in Japan.  The definition for each type of bleeding event should be investigated in further studies.

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Objective: The aim of this study was to propose a method for preparing motion pictures to visualize the geometrical propagation of influenza infection.  The Greater Tokyo area (Kanto region) of Japan, which has a population of 43 million, was considered as a typical epidemic area for the 2012/2013 flu season.  Therefore, we collected data regarding the daily variations in the number of flu patients from 285 pharmacies located in the Kanto region during that time period.
Design and Methods: To visualize the information mined from these big data, a motion picture consisting of 90 frames ranging from December 12, 2012 to March 21, 2013 was created.  Each frame depicted the daily image of infection as a circle centered at the pharmacy location on the background map, and its radius was proportioned to patient number.  The time variations of the flu patients at the pharmacies appeared to be noisy, which would cause the flickering on a display screen.  We adopted data smoothing and a model time series of the Gaussian distribution curve to circumvent the above problem.
Result: The created motion picture indicated that the 2012/2013 flu season began near the central part of Toyo in December, 2012, spread towards the suburbs, and ended in March, 2013.
Conclusion: The method proposed in this study can be considered an efficient and intuitive way to communicate essential epidemiological information.

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Objective: In this study, we evaluated the change in degree of recognition and understanding of palliative care as pharmacy students’ years advanced.
Methods: A questionnaire survey consisting of 11 items about recognition of narcotics and 27 items about understanding of palliative care was conducted with first- to fifth-year pharmacy students.  We divided the questions about the image of narcotics into groups and classified the questions about their knowledge of palliative care into the categories based on some reports.
Results: Among the three groups of questions about the image of narcotics, the degree of “right recognition of narcotics” increased, and those of “wrong recognition of narcotics” and “sense of resistance to narcotics” decreased as pharmacy students’ years advanced.  Additionally, questions about their knowledge of palliative care were categorized into three: “basic guidelines for cancer pain relief and methods of narcotic use,” “role of pharmacists in palliative care and support for patients,” and “pharmacologic characteristics of narcotics.”  Their degree of understanding of each category increased with an increase in years.  Both the recognition of narcotics and understanding of palliative care changed in the fourth- and fifth-grade year students compared to the first-, second-, and third-year ones.
Conclusion: These results suggest that the recognition and understanding of palliative care changed along the same trends as pharmacy students’ years advanced.  Therefore, it is important that pharmacy students acquire appropriate knowledge to play an active role in palliative care.

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