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Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02614638
Acronym
OPTI-PP
Enrollment
129
Registered
2015-11-25
Start date
2016-09-30
Completion date
2016-12-16
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalization

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.

Interventions

OTHEROne month of department-wide observation

A pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only. During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses. He / she will collect medication errors and other observational data.

OTHERPharm Tech participates in department

Following a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month. He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission5 daysPrimary Outcome Measure as given in protocol: Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (during month 1 versus during month 3).

Secondary

MeasureTime frameDescription
For each medication error: the name of the drug5 days
For each medication error: the type of error5 daysErrors are classifies as one of the following types: Omission; Drug; Dosage form; Expired or damaged drug; Dose; Concentration; Frequency of administration; Administration technique; Route of Administration; Rate of administration; Duration of administration; Administration Time; Patient; Drug interaction.
For each medication error: the severity index5 days
For each medication error: when (which step) the error occurred during the drug pathway5 daysThe considered steps are: Writing the prescription Medical decision for the prescription Transcription Pharmaceutical analysis Deliverance Preparation / reconstitution Pillbox Administration Procurement Storage Compliance Therapeutic and clinical follow-up
For each medication error: the evolution of the adverse drug event, if occurred5 days
For each medication error: the criticality of the error5 daysCriticality is graded according to the following classes: 1. C: no potential harm to the patient; 2. D: treatment or increased monitoring without harm to the patient 3. (E to I): potential harm to the patient 3E: treatment or surgery with temporary harm 3F: longer duration of hospitalization with temporary harm 3G: permanent harm 3H: involving a life-threatening harm 3I: death Criticality is determined by the concordance of two, independent expert opinions; or, in case of discordance, the concordance of 2 out 3 expert opinions.
The potential causes of medication errors5 days
The average number of interruptions per hour during preparation or administration of drug doses by nurses5 days
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 unit5 days
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 unit5 days
Nursing staff time dedicated to: the preparation of individual doses5 days
Nursing staff time dedicated to: ordering health products5 days
Number of patients with at least one medication error / total number of hospitalized patients included in the service5 days
Nursing staff time dedicated to: the delivery, receipt and storage of health products5 days
Nursing staff time dedicated to: cabinet inventories5 days
Nursing staff time dedicated to: the management of expired drugs5 days
The number of calls made to the central pharmacy5 days
Staff time dedicated to managing exceptional requests5 days
The number of immobilized drugs5 days
The number of immobilized medical devices5 days
The number of drugs consumed5 days
The number of medical devices consumed5 days
The cost of adverse drug events care5 days
Care staff satisfaction questionnaire5 days
Pharmacy technician satisfaction questionnaire5 days
Nursing staff time dedicated to: stock management and exceptional orders5 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026