Using PMDA Drug Adverse Event Report Database, Study on Collective Background of Adverse Events Caused by the Total Cold Medicine ： Classification of Onset Cases Using Latent Class Analysis / 薬剤疫学

Objective： Using PMDA's medication side effect database （JADER), the aim of this study is to explore the collective background and characteristics of cases in which adverse events were caused by the total cold medicine.Methods：Latent class analysis is performed on 990 subject cases reported from April 2004 to June 2015. The target group is classified into plural, and each characteristic is clearly indicated. Furthermore, the number of adverse events is counted for each class, and specialization coefficients are calculated. In addition, the signal detection is performed with the same data.Results：The population was divided into three classes. Class 1 was a group which do not have the original disease or medication, 53.7％ of the whole, and it was set as “health group” . Adverse events specialized were immune system diseases. Class 2 was 33.2％, a positive group for self-treatment, it was set as “self-treatment oriented group” . A specialized adverse event was a serious skin disorder. Class 3 was 13.1％, and 90％ of the class was over 60 years old and almost people had primary diseases and medicines, so they were “high age outpatient treatment group” . The main adverse events were lung disease and nervous system disorder. It was possible to relate the characteristic of the group as a background factor.Conclusion：By applying Latent class analysis to the adverse event, it was possible to clarify the relationship between the occurrence of adverse event and its background.This research is applicable to other medicines, and expected to contribute as a new application method of JADER.

Development of an Application for Using the Pharmaceuticals and Medical Devices Agency Side Effect Dataset More Effectively / 医薬品情報学

<b>Objective: </b>The Pharmaceuticals and Medical Devices Agency (PMDA) discloses reports with accumulated side effect information in comma-separated value (CSV) format.  It is difficult to use the information in this type of text file because the amount of data is large and composed of multiple fields.  Therefore, we developed an application that presents the data in a way that is easier to read and understand.<br><b>Methods: </b>The application can display the whole dataset, or the search results of certain medicines and side effects within the database in Microsoft Access 2013.  It exports data from search results into an Excel spreadsheet organized by medicine and side effect.<br><b>Results: </b>This application makes it possible to understand statistics contained in the side effect dataset, such as the number of cases, the medicines, and the side effects themselves.  Moreover, the application allows the totaled search results for the medicines and the side effects to be graphed.  It also makes it possible to understand the sex and age distribution of patients, as well as the days elapsed before developing a side effect.<br><b>Conclusions: </b>Recently, the importance of information concerning the safety of medicine has increased.  This system could facilitate the effective use of side effect information and the creation of medicine risk management plans in medical institutions.

Analysis of the Drug Monitoring Information by Using the CYP-Database for Predicting Drug-Drug Interactions / 医薬品情報学

<b>Objective: </b>In the previous study, the CYP database was constructed in order to relate drug-drug interactions to the CYP metabolic information of the package inserts.  In this study, we evaluated the clinical usefulness of the CYP database by using the Pharmaceutical and Medical Devices Agency (PMDA) Drug Monitoring Information.<br><b>Methods: </b>We examined the drugs in CYP isoform responsible for drug metabolism.  The age, sex, suspect drugs and co-administered drugs were extracted from 6,236 cases of the PMDA database of drug monitoring from January till November of 2008.<br><b>Results: </b>Twenty-three percent of all cases had co-administered drugs.  Forty-five percent of these cases were metabolized both suspect and co-administered drugs by the same CYP isoform, and three fourths of these cases were able to be detected only by the CYP database.  In addition, the administration of substrate medicines in combination with substrate medicines was the largest (57%), followed by cases of substrate medicines in combination with inhibitor medicines (28%).  Seventy-seven percent of the suspect drugs that had a large number of reported cases of side effects were substrate medicines, and the frequency of co-administration with substrate medicines was very high.<br><b>Conclusion: </b>These data suggest that the CYP database, being used together with package inserts, might be a clinically useful tool to avoid adverse events caused by drug-drug interactions.

Drug Safety Data on the Viewpoint of a Physician: / 薬剤疫学

From the standpoint of a physician, drug safety data include not only information on adverse effects, but also information required to perform drug therapy safely. Drug safety data required by physicians include pharmacological data, name of the drug, history and physical data of patients, and an electronic or paper-based prescribing system at the clinic. Although most physicians are generally interested in drug safety data, a focus is not placed on adverse effects, given that they represent only a minor fraction of what is required for clinical practice and prescribing drugs. Moreover, Japanese physicians, who are busy with daily clinical practice, cannot find the time to extract essential information from what is supplied or to manage, make use, and report adverse events.<Br>Many problems exist in the management of drug safety data, especially for adverse effects, including collection of data, database management, and feedback to physicians. In particular, current adverse effect reporting systems rely too heavily on physicians. In order to improve the sensitivity and management of drug safety data in Japan, it is expected that not only physicians but also pharmacists, paramedical staff, and patients will report drug safety data. One promising possibility is the establishment of a special division at all medical facilities that manages drug safety data. This concept is similar to that of the Governmental Consumer Agency (Shohisha-cho) launched in 2009. As an issue, drug safety traverses all of healthcare, so it may be necessary for the drug safety division to adopt not only specialists whose subspecialties are more focused, but also general physicians.