Adverse drug event monitoring at the food and drug administration
نویسندگان
چکیده
منابع مشابه
Mortality and oral anticoagulants in the Food and Drug Administration Adverse Event Reporting System
OBJECTIVE The comparative crude death rates (CDR) among non-vitamin K antagonist oral anticoagulants (NOACs) are unknown. Further, whether NOACs improve survival when compared with warfarin is also unclear. We compared CDR co-reported for four NOACs combined or separately versus warfarin within the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. METHODS ...
متن کاملLeveraging Food and Drug Administration Adverse Event Reports for the Automated Monitoring of Electronic Health Records in a Pediatric Hospital
The objective of this study was to determine whether the Food and Drug Administration's Adverse Event Reporting System (FAERS) data set could serve as the basis of automated electronic health record (EHR) monitoring for the adverse drug reaction (ADR) subset of adverse drug events. We retrospectively collected EHR entries for 71 909 pediatric inpatient visits at Cincinnati Children's Hospital M...
متن کاملPharmacist 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...
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ژورنال
عنوان ژورنال: Journal of General Internal Medicine
سال: 2003
ISSN: 0884-8734,1525-1497
DOI: 10.1046/j.1525-1497.2003.20130.x