Drug-Related Problems : Focus on Age and Diabetes (DRP-AD)

Observatory of Drug-Related Problems: Impact of the Age and the Presence of Diabetes

Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs.

DRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including

• medication reconciliation,
• an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients.

In this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP.

Translated with www.DeepL.com/Translator (free version)

Study Overview

• Status: Completed
• Conditions: Adverse Drug Events
• Intervention / Treatment: Other: Detection of Adverse Drug Events or Drug-Related Problems

• Study Type: Observational
• Enrollment (Actual): 27000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

- Patients aged above 18 years old, admitted to the emergency department or hospital

Exclusion criteria:

• Patients presenting acute psychological disturbance
• Patients that did not agree to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with an Adverse Drug Events or Drug-Related Problems	Other: Detection of Adverse Drug Events or Drug-Related Problems; Detection of Adverse Drug Events or Drug-Related Problems
Patients without an Adverse Drug Events or Drug-Related Problems	Other: Detection of Adverse Drug Events or Drug-Related Problems; Detection of Adverse Drug Events or Drug-Related Problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems	Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of Adverse Drug Events and Drug-Related Problems	Number and type of Adverse Drug Events and Drug-Related Problems	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Diabetes; Drug-Related Problems; Clinical Pharmacist
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: RECHMPL20_0667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No