Serious adverse Drug events reported to the Food and Drug Administration (FDA): analysis of the FDA adverse event reporting system (FAERS) 2006-2011 database
نویسندگان
چکیده
منابع مشابه
Pharmacist reporting of serious adverse drug events to the Food and Drug Administration.
OBJECTIVE To identify barriers to and facilitators of pharmacist reporting of serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHOD Two focus groups consisting of practicing pharmacists were held in Austin, TX, in 2009. The following open-ended questions were used in the focus groups: (1) What do you think would make it easier to report serious ADEs to the FDA? ...
متن کاملTexas pharmacists' knowledge of reporting serious adverse drug events to the Food and Drug Administration.
OBJECTIVES To assess Texas pharmacists' knowledge of adverse drug event (ADE) reporting to the Food and Drug Administration (FDA) and to determine demographic and practice characteristics associated with this knowledge. DESIGN Cross-sectional descriptive study. SETTING Austin, TX, in June and July 2009. PARTICIPANTS 377 pharmacists practicing in hospital and community settings. INTERVEN...
متن کاملSerious adverse drug events reported to the Food and Drug Administration, 1998-2005.
BACKGROUND The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers. METHODS Using extracts published for research use, we analyzed all serious adverse drug events and medication errors in the United States reported to the Food and Drug...
متن کاملStimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)
BACKGROUND The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse...
متن کاملAdverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database
INTRODUCTION The growing problem of antibacterial resistance resulted in an increased interest in fosfomycin, especially its parenteral formulation. We reviewed fosfomycin safety profile using the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS) and published literature. METHODS We conducted a FAERS search and disproportionality analysis of all fosfomycin-associated AE...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2015
ISSN: 1098-3015
DOI: 10.1016/j.jval.2015.03.502