An observational study in Adverse Drug Event, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by University Hospital, Montpellier · Observational
Emergency departments (EDs) are a crucial element of the health care systems at interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hour per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that pharmacists but also student pharmacists were one of the best health care providers to establish medication history. Consequently, the aims of our study were to assess prevalence and characteristics of ADEs identified in an emergency department and to identify factors associated with ADEs in ED patients.
This prospective observational study is conducted at the ED of a tertiary care hospital (University hospital of Montpellier). This department supports 80 000 patients every years. Patient were not included if they were less than 18 years old, present acute psychological disturbance or they did not agree to participate at this study.
For each patient included, a pharmaceutical team conducted: medication reconciliation process to establish medication history and a structured interviews to determine self-reported adherence and self-medication. ADEs were attributed to a medication by the treating senior emergency physician: directly during patient consultation or after being alerted by the pharmaceutical team.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's enrollment of 13,453 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population was composed of patient admitted in emergency department of Montpellier University hospital.
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Exclusion criteria:
People with adverse drug event
Other: Detection of adverse drug events
People without adverse drug event
Detection of adverse drug events
Number of adverse drug events
Number of adverse drug events identified in a emergency deparmtent
Time frame: 1 day
number of variable associated with adverse drug events
number of variable associated with adverse drug events in ermergency department patients
Time frame: 1 day
Plan to share: Undecided — NC
Ran from Nov 2011 to primary completion in Dec 2019, 97 months.
Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's 97 months is above that.
Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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