The FDA Drug Safety Surveillance Program: Adverse Event Reporting Trends
نویسندگان
چکیده
منابع مشابه
Standardizing adverse drug event reporting data
BACKGROUND The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly a...
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Individual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Public available ICSRs reported in children (0-18 years) to FAERS were downloaded from the FDA-webs...
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Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Advers...
متن کاملData Mining of the Public Version of the FDA Adverse Event Reporting System
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, rep...
متن کاملTailoring adverse drug event surveillance to the paediatric inpatient
INTRODUCTION Although paediatric patients have an increased risk for adverse drug events, few detection methodologies target this population. To utilise computerised adverse event surveillance, specialised trigger rules are required to accommodate the unique needs of children. The aim was to develop new, tailored rules sustainable for review and robust enough to support aggregate event rate mon...
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ژورنال
عنوان ژورنال: Archives of Internal Medicine
سال: 2011
ISSN: 0003-9926
DOI: 10.1001/archinternmed.2011.89