Incidence and Risk Factor of Drug Related Problem Detected in Inpatient (DRPINPAT)

Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines and achieving achieve the desired therapeutic outcomes. Pharmaceutical care identifies and resolves actual or potential DRPs.

DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and may result in morbidity or mortality and increased health care costs. Health care costs may become a burden to the patient or may be to the government or to the third parties. Clinical Pharmacy is a discipline that promotes the quality use of medicines through evidence-based medicine and helps in identification and resolving DRPs. A clinical pharmacist through his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to resolve the same.

Consequently, the aims of our study were to assess prevalence and characteristics of DRPs identified in inpatient and to identify factors associated with DRPs.

Study Overview

• Status: Recruiting
• Conditions: Drug Related Problem
• Intervention / Treatment: Other: Detection of drug related problem in inpatient

Detailed Description

At admission, pharmaceutics' team (senior pharmacist, one resident and two pharmacy students), conducted medication reconciliation process within 24 hours of admission or on the first working day following admission for admissions during week-ends. A medication reconciliation process was conducted according to a validated protocol. The first step consists of getting the Best Possible Medication History (BPMH), defined as the most comprehensive list of all medications taken by the patient. The second step consists of comparing the BPMH with admission prescription made by the physician in charge.

During pharmacist interview, pharmacist discussed about medication adherence and knowledge.

The third step consists of characterizing, solving and documenting DRPs. Each DRP highlighted by pharmaceutical team were collected and were classified regarding drug class and problem' types. For each patient with an identified DRP, the potential clinical impact was determined through a consensus of an expert panel: 2 pharmacists (1 hospital senior pharmacist and the resident) and 2 senior clinicians from the clinical department. The index used to rate the significance of the errors was based on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for categorizing medication errors and adapted to get 4 severity categories with the type of error that leads to this severity: very serious, serious, moderate and minor.

For each medication, we collected its name, dosage, dosage forms and frequency of administration. For each DRP, we collected the type of DRP, the drug classes (according to anatomical therapeutic chemical classification system) and the potential clinical impact for the patient.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • 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 hospitalized in Montpellier University hospital.

Description

Inclusion criteria:

- Patients aged above 18 years old, admitted to the department during the study period and hospitalized for at least 24 hours

Exclusion criteria:

- NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient with drug related problem	Other: Detection of drug related problem in inpatient; Detection of drug related problem in inpatient
patient without drug related problem	Other: Detection of drug related problem in inpatient; Detection of drug related problem in inpatient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of drug related problems	Number of drug related problems identified in inpatient	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of variable associated with drug related problems	number of variable associated with drug related problems	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Cyril BREUKER, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): November 1, 2035
• Study Completion (Anticipated): January 1, 2036

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: inpatient; Clinical Pharmacist; Drug related problem; Medication Error
• Other Study ID Numbers: RECHMPL18_0135

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