Adverse Drug Events at Emergency Department

NCT03442010 | Completed

• 1 other identifier: RECHMPL18_0095
• Study Type: observational
• Target: 13,453
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adverse Drug Event

Keywords

Emergency department; Clinical Pharmacist; Adverse drug event

Outcome Measures

Primary Outcomes (1)

• Number of adverse drug events

  Number of adverse drug events identified in a emergency deparmtent

  1 day

Secondary Outcomes (1)

• number of variable associated with adverse drug events

  1 day

Study Arms (2)

People with adverse drug event

People with adverse drug event

Other: Detection of adverse drug events

People without adverse drug event

People without adverse drug event

Interventions

Detection of adverse drug events OTHER

Detection of adverse drug events

People with adverse drug event

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population was composed of patient admitted in emergency department of Montpellier University hospital.

You may qualify if:

• \- Patients aged above 18 years old, admitted to the department during the study period

You may not qualify if:

• \- Patient presenting acute psychological disturbance or they did not agree to participate at this study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (2)

• Lohan L, Marin G, Faucanie M, Laureau M, Macioce V, Perier D, Pinzani V, Giraud I, Castet-Nicolas A, Jalabert A, Villiet M, Sebbane M, Breuker C. Impact of medication characteristics and adverse drug events on hospital admission after an emergency department visit: Prospective cohort study. Int J Clin Pract. 2021 Jul;75(7):e14224. doi: 10.1111/ijcp.14224. Epub 2021 Apr 23.

  PMID: 33866662 DERIVED

• Laureau M, Vuillot O, Gourhant V, Perier D, Pinzani V, Lohan L, Faucanie M, Macioce V, Marin G, Giraud I, Jalabert A, Villiet M, Castet-Nicolas A, Sebbane M, Breuker C. Adverse Drug Events Detected by Clinical Pharmacists in an Emergency Department: A Prospective Monocentric Observational Study. J Patient Saf. 2021 Dec 1;17(8):e1040-e1049. doi: 10.1097/PTS.0000000000000679.

  PMID: 32175969 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Emergencies

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cyril BREUKER

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: November 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)