CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Completed
NCT Number: NCT02614638
Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy
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
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
One month of department-wide observation
OtherA 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.
Pharm Tech participates in department
OtherFollowing 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.
Primary outcomes
-
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
Time frame: 5 days
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).
Secondary outcomes
-
Number of patients with at least one medication error / total number of hospitalized patients included in the service
Time frame: 5 days
-
For each medication error: the name of the drug
Time frame: 5 days
-
For each medication error: the type of error
Time frame: 5 days
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.
-
For each medication error: the severity index
Time frame: 5 days
-
For each medication error: when (which step) the error occurred during the drug pathway
Time frame: 5 days
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
-
For each medication error: the evolution of the adverse drug event, if occurred
Time frame: 5 days
-
For each medication error: the criticality of the error
Time frame: 5 days
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.
-
The potential causes of medication errors
Time frame: 5 days
-
The average number of interruptions per hour during preparation or administration of drug doses by nurses
Time frame: 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
Time frame: 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
Time frame: 5 days
-
Nursing staff time dedicated to: the preparation of individual doses
Time frame: 5 days
-
Nursing staff time dedicated to: ordering health products
Time frame: 5 days
-
Nursing staff time dedicated to: stock management and exceptional orders
Time frame: 5 days
-
Nursing staff time dedicated to: the delivery, receipt and storage of health products
Time frame: 5 days
-
Nursing staff time dedicated to: cabinet inventories
Time frame: 5 days
-
Nursing staff time dedicated to: the management of expired drugs
Time frame: 5 days
-
The number of calls made to the central pharmacy
Time frame: 5 days
-
Staff time dedicated to managing exceptional requests
Time frame: 5 days
-
The number of drugs consumed
Time frame: 5 days
-
The number of medical devices consumed
Time frame: 5 days
-
The number of immobilized drugs
Time frame: 5 days
-
The number of immobilized medical devices
Time frame: 5 days
-
The cost of adverse drug events care
Time frame: 5 days
-
Care staff satisfaction questionnaire
Time frame: 5 days
-
Pharmacy technician satisfaction questionnaire
Time frame: 5 days
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Other
Registry information
Official study 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
Acronym: OPTI-PP
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Nov 25, 2015
- Registry last updated
- Feb 1, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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