Clinical trial NCT02614638: Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy
Official title: Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.

This is a before-after study consisting of three sequential phases:

Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department

Detailed description: The secondary objectives of this study are:

A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.

B- To characterize detected medication errors.

C- To identify and evaluate the potential causes of medication errors.

D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.

E- To evaluate the economic impact of the presence of a pharmacy technician.

F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.

Eligibility criteria: Inclusion Criteria:

* The patient must be insured or beneficiary of a health insurance plan
* The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital

Exclusion Criteria:

* The patient is under judicial protection
* The patient, or his/her legal guardian, expresses opposition to participation in the study
* It is impossible to correctly inform the patient

Primary outcomes:
measure: The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission
timeFrame: 5 days
Secondary outcomes:
measure: Number of patients with at least one medication error / total number of hospitalized patients included in the service
timeFrame: 5 days
measure: For each medication error: the name of the drug
timeFrame: 5 days
measure: For each medication error: the type of error
timeFrame: 5 days
measure: For each medication error: the severity index
timeFrame: 5 days
measure: For each medication error: when (which step) the error occurred during the drug pathway
timeFrame: 5 days
measure: For each medication error: the evolution of the adverse drug event, if occurred
timeFrame: 5 days
measure: For each medication error: the criticality of the error
timeFrame: 5 days
measure: The potential causes of medication errors
timeFrame: 5 days
measure: The average number of interruptions per hour during preparation or administration of drug doses by nurses
timeFrame: 5 days
measure: The number of patients for whom personal treatments were managed by the nursing staff on admission / number of patients who brought their personal treatments to the care unit
timeFrame: 5 days
measure: The number of patients for whom personal treatments were returned by the nursing staff at hospital discharge / number of patients who brought their personal treatments to the care unit
timeFrame: 5 days
measure: Nursing staff time dedicated to: the preparation of individual doses
timeFrame: 5 days
measure: Nursing staff time dedicated to: ordering health products
timeFrame: 5 days
measure: Nursing staff time dedicated to: stock management and exceptional orders
timeFrame: 5 days
measure: Nursing staff time dedicated to: the delivery, receipt and storage of health products
timeFrame: 5 days
measure: Nursing staff time dedicated to: cabinet inventories
timeFrame: 5 days
measure: Nursing staff time dedicated to: the management of expired drugs
timeFrame: 5 days
measure: The number of calls made to the central pharmacy
timeFrame: 5 days
measure: Staff time dedicated to managing exceptional requests
timeFrame: 5 days
measure: The number of drugs consumed
timeFrame: 5 days
measure: The number of medical devices consumed
timeFrame: 5 days
measure: The number of immobilized drugs
timeFrame: 5 days
measure: The number of immobilized medical devices
timeFrame: 5 days
measure: The cost of adverse drug events care
timeFrame: 5 days
measure: Care staff satisfaction questionnaire
timeFrame: 5 days
measure: Pharmacy technician satisfaction questionnaire
timeFrame: 5 days
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Géraldine Leguelinel-Blache, PharmD, PhD
role: STUDY_DIRECTOR
References: