Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005
نویسندگان
چکیده
منابع مشابه
Serious 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 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 کاملInfluence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration.
AIM To investigate the influence of pharmacists' attitudes on intention to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHODS This cross-sectional study used a mail survey to collect data from hospital and community pharmacists practicing in Texas, United States. Three and 16 items were used to measure intention and attitudes, respectively, using a se...
متن کاملAutologous cultured chondrocytes: adverse events reported to the United States Food and Drug Administration.
BACKGROUND Carticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of symptomatic cartilaginous defects of the femoral condyle that are caused by acute or repetitive trauma in patients who have been previously managed with arthroscopy or other surgical procedures. The present report describes the adverse even...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Archives of Internal Medicine
سال: 2007
ISSN: 0003-9926
DOI: 10.1001/archinte.167.16.1752