Incidence and Risk Factor of Drug Related Problem Detected in Inpatient

NCT ID: NCT03476733

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2036-01-01

Brief Summary

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.

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.

Conditions

Drug Related Problem

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient with drug related problem

patient with drug related problem

Detection of drug related problem in inpatient

Intervention Type: OTHER

Detection of drug related problem in inpatient

patient without drug related problem

patient without drug related problem

Detection of drug related problem in inpatient

Intervention Type: OTHER

Detection of drug related problem in inpatient

Interventions

Detection of drug related problem in inpatient

Detection of drug related problem in inpatient

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyril BREUKER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cyril BREUKER, PharmD,Phd

Role: CONTACT

c-breuker@chu-montpellier.fr

467337121 ext. 33

Facility Contacts

cyril BREUKER

Role: primary

c-breuker@chu-montpellier.fr

Other Identifiers

RECHMPL18_0135

Identifier Type: -

Identifier Source: org_study_id