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.