著者

林 剛 舘 知也 野口 義紘 杉岡 まゆ子 青山 智 田中 和秀 安田 昌宏 後藤 千寿 山田 浩司 水井 貴詞 寺町 ひとみ

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.47, no.9, pp.464-476, 2021-09-10 (Released:2022-09-10)

参考文献数

15

---

In this study, we evaluated the effect of risk minimization activities in a risk management plan (RMP) formulated for sodium-glucose cotransporter-2 (SGLT2) inhibitors using both the Japanese Adverse Drug Event Report database (JADER) and real-world clinical data. We extracted data from the JADER, which is maintained by the Pharmaceuticals and Medical Devices Agency, from the first quarter of 2004 to the second quarter of 2020. We also used real-world clinical data of the patients who took SGLT2 inhibitors among those who visited or were admitted to Gifu Municipal Hospital from June 2014 to January 2018. We conducted a comparison before and after implementing the risk minimization activities. We compared the reported rate of clinical trials with the reported rate after marketing using the JADER. In addition, we compared the prevalence rate of the clinical trials of SGLT2 inhibitors with that in real clinical data. Furthermore, we compared the onset of side effects (in days) reported in clinical trials recorded in the JADER with that in real clinical data. The pre/post comparison showed a significant increase in the reported rates of increased ketone body, volume depletion, urinary tract infections, and genital infections. A significant decrease in the prevalence rates for hypoglycemia and increased ketone body was also observed. Moreover, the time to onset of side effects was significantly shortened in volume depletion. In conclusion, the risk minimization activities in RMP would contribute to the increased reported rate, decreased prevalence rate, and early detection of side effects.

著者

舘 知也 加藤 未紗 大澤 友裕 甲田 明英 福田 聖啓 田中 和秀 青山 智 安田 昌宏 水井 貴詞 後藤 千寿 寺町 ひとみ

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

vol.133, no.11, pp.1223-1233, 2013 (Released:2013-11-01)

参考文献数

19

被引用文献数

3 5

---

Since April 2011, a dosage adjustment program has been implemented at Gifu Municipal Hospital. In this program, upon receiving a prescription for renally eliminated drugs, pharmacists verify patients' serum creatinine concentrations by using a computerized medical record system to evaluate the patient's kidney function and suggest the appropriate dosage to doctors, if necessary. In our study, we used questionnaires that were administered to pharmacists and doctors at the hospital to investigate their respective working times and the cost of the program, in order to comprehensively analyze the clinical resource costs of the hospital and evaluate the economic burden of the program for levofloxacin. In addition, we studied the pharmacists' and doctors' attitudes toward the program and the circumstances of prescriptions for patients with renal dysfunction. The questionnaire comprised items such as time required for the program; attitude toward the program, including satisfaction; and attitude toward the circumstances of prescriptions for patients with renal dysfunction. The pharmacists' and doctors' working times and cost of the program were obtained from the questionnaire responses. For cost estimation, we used data from this study as well as those of our previous study that suggested that the levofloxacin program was economically beneficial. Furthermore, their attitudes toward the program and circumstances of prescriptions for patients with renal dysfunction were clarified. Regarding the pharmacists' tasks and interventions, we need to not only investigate attitudes toward them but also perform a cost analysis by the method of the economic evaluation of the medical techniques used in our study.