Biomaterial Database

[Analysis of Spontaneously Reported Adverse Events]. 2016

Mitsuhiro Nakamura

Drug Informatics, Gifu Pharmaceutical University.

Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance algorithms were used for signal detection, including the reporting odds ratio. An SRS is a passive reporting database and is therefore subject to numerous sources of selection bias, including overreporting, underreporting, and a lack of a denominator. Despite the inherent limitations of spontaneous reporting, SRS databases are a rich resource and data mining index that provide powerful means of identifying potential associations between drugs and their adverse effects. Our results, which are based on the evaluation of SRS databases, provide essential knowledge that could improve our understanding of clinical issues.

UI	MeSH Term	Description	Entries
D007564	Japan	A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo.	Bonin Islands
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D016907	Adverse Drug Reaction Reporting Systems	Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions.	Adverse Drug Reaction Reporting System,Drug Reaction Reporting Systems, Adverse
D057225	Data Mining	Use of sophisticated analysis tools to sort through, organize, examine, and combine large sets of information.	Text Mining,Mining, Data,Mining, Text
D060735	Pharmacovigilance	The detection of long and short term side effects of conventional and traditional medicines through research, data mining, monitoring, and evaluation of healthcare information obtained from healthcare providers and patients.	Pharmacovigilances
D019992	Databases as Topic	Works on organized collections of records, standardized in format and content, that are stored in any of a variety of computer-readable modes.	Data Banks as Topic,Data Bases as Topic,Databanks as Topic