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The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in ...
Variations in healthcare provider training & experience [45] [52] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk. [53] [54] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.
One of the main conclusions was that the majority of medical errors do not result from individual recklessness or the actions of a particular group; rather, most errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent adverse events. Thus, the Report recommended mistakes can best be ...
Bar code medication administration was designed as an additional check to aid the nurse in administering medications; however, it cannot replace the expertise and professional judgment of the nurse. The implementation of BCMA has shown a decrease in medication administration errors in the healthcare setting. [6]
Much of the research and focus on adverse events has been on medication errors–the most frequently reported adverse event for both adult and pediatric patients. [115] It is also of interest to note that medication errors are also the most preventable type of harm that can occur within the pediatric population.
State regulators faulted two hospitals in Southern California for medication errors that put patients at risk, including one who suffered a brain bleed after receiving repeated doses of blood thinner.
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
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