Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy (OPTI-PP)

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

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

Study Overview

• Status: Completed
• Conditions: Hospitalization
• Intervention / Treatment: Other: One month of department-wide observation; Other: Pharm Tech participates in 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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1st observational period (before experimental intervention); Patients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation	Other: One 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.
Experimental: 2nd obs. period (during experimental intervention); Following a one-month wash-out period, patients in this arm are included during a second month of observation during which the intervention is implemented. Intervention: Pharm Tech participates in department	Other: Pharm 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Primary 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).	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with at least one medication error / total number of hospitalized patients included in the service		5 days
For each medication error: the name of the drug		5 days
For each medication error: the type of error	Errors 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.	5 days
For each medication error: the severity index		5 days
For each medication error: when (which step) the error occurred during the drug pathway	The 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	5 days
For each medication error: the evolution of the adverse drug event, if occurred		5 days
For each medication error: the criticality of the error	Criticality is graded according to the following classes: C: no potential harm to the patient;; D: treatment or increased monitoring without harm to the patient; (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.	5 days
The potential causes of medication errors		5 days
The average number of interruptions per hour during preparation or administration of drug doses by nurses		5 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 unit		5 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 unit		5 days
Nursing staff time dedicated to: the preparation of individual doses		5 days
Nursing staff time dedicated to: ordering health products		5 days
Nursing staff time dedicated to: stock management and exceptional orders		5 days
Nursing staff time dedicated to: the delivery, receipt and storage of health products		5 days
Nursing staff time dedicated to: cabinet inventories		5 days
Nursing staff time dedicated to: the management of expired drugs		5 days
The number of calls made to the central pharmacy		5 days
Staff time dedicated to managing exceptional requests		5 days
The number of drugs consumed		5 days
The number of medical devices consumed		5 days
The number of immobilized drugs		5 days
The number of immobilized medical devices		5 days
The cost of adverse drug events care		5 days
Care staff satisfaction questionnaire		5 days
Pharmacy technician satisfaction questionnaire		5 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Géraldine Leguelinel-Blache, PharmD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 16, 2016
• Study Completion (Actual): December 16, 2016

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2015/GL-01; 2015-A01309-40 (Other Identifier: RCB number)