Actual Class Contents Related to the Drug and Medical Device Safety Information Reporting System in Medical Schools across Japan

Abstract

Under the Drug and Medical Device Safety Information Reporting System, medical and pharmaceutical professionals are required to report information about adverse drug reactions to the Minister of Health, Labour and Welfare of Japan. In this study, we aim to investigate classes related to this system in the universities with medical schools across Japan. We had asked the universities with medical schools, nationwide, to participate in the study. Then, we collected information from them on the courses related to this system. Of 82 universities in total, 32 universities （39.0％）responded with the contents of such courses and 11 universities（13.4％）responded that they have no such classes. The courses related to this system, included 15 pharmacology courses, 9 medical safety/management courses, 10 clinical pharmacology/pharmacotherapy courses, 8 hygiene/public health courses, and 19 other courses. The most common grade in which these courses were taught was the 4th year, and only two universities had these courses in the 5th and 6th years. There was only one course in which drug safety information report forms were actually “filled in” by the students. In the free description columns, there were relatively many responses referring to the importance of making the students understand the pharmacokinetic/pharmacological mechanisms of adverse drug reactions and the necessity for the improvement of understanding of drug-induced sufferings including history. In conclusions, the lectures of this system in the medical schools were mainly conducted in pharmacology and clinical pharmacology/pharmacotherapy courses. However, lectures in the 5th and 6th years were insufficient, and the number of courses in which practical training and exercises were conducted was limited.