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: The guidance on “what to do when patients missed a dose” is an important item of medication instructions; however, only a small number of prescription drugs contain it. The “Drug Guide for Patients” and “Kusuri-no-Shiori” are documents designed to facilitate medication instructions for patients, having a section on “what to do when patients missed a dose.” Specific descriptions under it differ among medication instruction documents for some drugs, including those containing the same active pharmaceutical ingredients; however, the actual status of such discrepancies has not been clarified. In this study, we conducted a fact-finding survey to clarify such discrepancies using two medication instruction documents for drugs containing the same active pharmaceutical ingredients.Methods: The medication instructions of “Drug Guides for Patients” and “Kusuri-no-Shiori” for 532 active pharmaceutical ingredients used in oral drugs were included in the survey. After reading the descriptions under the “what to do when patients missed a dose” section, we divided them into six groups and determined whether the descriptions for the same ingredient in the documents fell in the same group.Results: For 186 ingredients (35.0%), we identified discrepancies between the documents. Among these, the instructions for 61 ingredients (11.5%) contained contradicting descriptions, such as “take the missed dose as soon as you remember” in one document and “always let go of the missed dose” in another document.Conclusions: A substantial number of discrepancies in descriptions about “what to do when patients missed a dose” were found between the two documents, raising concerns of confusion in medication instructions when the documents used were different. Therefore, the descriptions should be improved to resolve the discrepancies among medication instruction documents. Moreover, it is important for pharmacists or other healthcare professionals to review the descriptions thoroughly before using the document to provide appropriate medication instructions without confusion.

Objective: The use of direct oral anticoagulants (DOACs) has increased because they have some advantages over warfarin, such as fewer interactions and no requirement for coagulation monitoring in principle. DOACs have dose adjustment requirement based on renal function and other complex criteria that differ depending on specific DOAC preparations and indications. At the Nagoya City East Medical Center, DOAC dose‒related decisions previously depended on the knowledge and discretion of individual pharmacists. However, a dose checking sheet for DOACs (the Checking Sheet) was prepared and used on our electronic medical record system since September 2016 to increase the reliability of prescription checking, eliminate improper prescriptions, and ensure electronic documentation of pharmaceutical inquiries. In this study, we compared percentages of proper prescriptions before and after the introduction of the Checking Sheet to assess the effectiveness of its use, which has not been reported previously.Method: The percentage of proper DOAC prescriptions was used as a measure to assess the effectiveness of the Checking Sheet. We investigated DOAC prescriptions from March 2017, when the Checking Sheet system had been established, and compared those with prescriptions from March 2016 (before the Checking Sheet was introduced). Prescriptions of rivaroxaban, apixaban, edoxaban, and dabigatran for nonvalvular atrial fibrillation or venous thromboembolism were included; prescriptions dispensed outside the hospital were excluded.Result: DOAC prescriptions before and after the Checking Sheet introduction were similar in number. The percentage of proper prescriptions increased significantly from 82.4 to 94.3%. Among specific DOAC preparations, the number of improper prescriptions decreased significantly for apixaban and showed a tendency to decrease for rivaroxaban.Conclusion: The increases in the number of proper DOAC prescriptions observed after introducing the Checking Sheet showed that the Checking Sheet helped ensure a certain level of prescription checking, suggesting its usefulness for promoting proper DOAC use.