The patient was a 57-year-old woman. Even though she had received a diagnosis of tetralogy of Fallot as an student of elementary school, she did not consent to undertake surgical repair. Consequently, she had been observed until age 56, although she suffered from atrial fibrillation during this period. She decided to undergo surgical correction as she suffered from severe heart failure. The surgical repair included Maze procedure, a patch repair of ventricular septal defect, a repair of the right ventricular outflow tract and a pulmonary valve replacement. The right ventricular pressure reduced to around two-fifths of high left ventricular pressure postoperatively, and she was discharged without any complication.

To raise a level of safety and to enhance the effectiveness of complicated drug therapy, various drug monitoring programs have been implemented in these days. In the present study, we examined whether pharmaceutical care plans proposed by pharmacists contributed to drug therapy.The number of pharmaceutical proposals from pharmacists, which were adopted and put into poactice in the clinical stages, has increased annually and totaled 1,014 cases in the past four years. The number of proposals related to cancer chemotherapy increased remarkably. Moreover, most of the cancer-related proposals conserned drug dosage, suggesting that the pharmaceutical care by pharmacists may contribute to the safety management of drugs in drug therapy. Additionally, in the other clinical cases than cancer chemotherapy cases, there was an increase in the number of proposals based on patient's conditions and clinical examination data, which suggests frequent participation of pharmacists in drug therapy. Furthermore, it was found that 62.6% of the all pharmaceutical proposals were made by wards-resident pharmacists. This suggests that an increase in the numbrt of wards-resident pharmacists will contribute to more effective and safer drug therapy in the future.
pharmacotherapeutic ; Safety ; seconds ; Clinical ; Drug Monitoring

Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.