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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01309-40 | Other Identifier | RCB number |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st observational period (before experimental intervention) | Active Comparator | Patients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation |
|
| 2nd obs. period (during experimental intervention) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One month of department-wide observation | Other | 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. |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Géraldine Leguelinel-Blache, PharmD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| Pharm Tech participates in department | Other | 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. |
|
| 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:
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 |