Kiyoto Naito, Hiroyuki Fujii, Eri Inoue, T. Yoshii, M. Shinohara, Shinichi Yamaguchi
baseline serum potassium levels affected the onset of the disease in clinical practice. Previous studies also reported the effects of renal insufficiency and other factors on the onset of hyperkalemia. ARB should be prescribed carefully in patients with these factors, as is conventionally done. science
{"title":"Risk of Hyperkalemia due to the Administration of Angiotensin Ⅱ Type 1 Receptor Blocker and Calcium Channel Blocker： Retrospective Cohort Study Based on Japanese Medical Information Database.","authors":"Kiyoto Naito, Hiroyuki Fujii, Eri Inoue, T. Yoshii, M. Shinohara, Shinichi Yamaguchi","doi":"10.3820/jjpe.26.e5","DOIUrl":"https://doi.org/10.3820/jjpe.26.e5","url":null,"abstract":"baseline serum potassium levels affected the onset of the disease in clinical practice. Previous studies also reported the effects of renal insufficiency and other factors on the onset of hyperkalemia. ARB should be prescribed carefully in patients with these factors, as is conventionally done. science","PeriodicalId":14576,"journal":{"name":"Japanese Journal of Pharmacoepidemiology\\/yakuzai Ekigaku","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82627539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
K. Ohga, Takako Sugita, Akihiro Seki, Teruyuki Honda, Genta Kawaguchi
Monitoring of the safety profile for the approved medical products consists of routine pharmacovigilance activities for all drugs and additional pharmacovigilance activities for product-specific concerns. Signal management is an important part of routine pharmacovigilance activities, so EMA and FDA have published the guidelines for signal management in various documents. The AMED Risk Management Plan（RMP） research group, which started its activities in 2018 to enhance risk management plan in Japan, reviewed the guidelines and related articles and then put together the principles of signal management. The guidelines in EU and US describes the signal detection and evaluation methods including points to consider when conducting them, responsibilities of each action, and the procedures that the regulatory authorities disclose the outcome of their activities, in addition to the principles and procedures of signal management. Through the guidelines, they establish transparency for public including pharmaceutical industry. Our group first created the Japanese definitions of signal-related terms. Based on them, we created high-level concept for a series of activities from signal detection to risk identification and discussed the future vision of signal management in Japan.
{"title":"Concept of Routine Pharmacovigilance, Especially Signal Management in the US and Europe","authors":"K. Ohga, Takako Sugita, Akihiro Seki, Teruyuki Honda, Genta Kawaguchi","doi":"10.3820/jjpe.26.e6","DOIUrl":"https://doi.org/10.3820/jjpe.26.e6","url":null,"abstract":"Monitoring of the safety profile for the approved medical products consists of routine pharmacovigilance activities for all drugs and additional pharmacovigilance activities for product-specific concerns. Signal management is an important part of routine pharmacovigilance activities, so EMA and FDA have published the guidelines for signal management in various documents. The AMED Risk Management Plan（RMP） research group, which started its activities in 2018 to enhance risk management plan in Japan, reviewed the guidelines and related articles and then put together the principles of signal management. The guidelines in EU and US describes the signal detection and evaluation methods including points to consider when conducting them, responsibilities of each action, and the procedures that the regulatory authorities disclose the outcome of their activities, in addition to the principles and procedures of signal management. Through the guidelines, they establish transparency for public including pharmaceutical industry. Our group first created the Japanese definitions of signal-related terms. Based on them, we created high-level concept for a series of activities from signal detection to risk identification and discussed the future vision of signal management in Japan.","PeriodicalId":14576,"journal":{"name":"Japanese Journal of Pharmacoepidemiology\\/yakuzai Ekigaku","volume":"53 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85719521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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